VAERS 2021 Database www.vaers.hhs.gov

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VAERS Updated: 11/12/2021
** VAERS DATABASE Last updated: November 12, 2021**
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Manufacturers

Total Manufacturer
199,106MODERNA
36,710JANSSEN
5,381PFIZER\BIONTECH
2,555GLAXOSMITHKLINE BIOLOGICALS
1,469UNKNOWN MANUFACTURER
897MERCK & CO. INC.
627SEQIRUS, INC.
112DYNAVAX TECHNOLOGIES CORPORATION
91SANOFI PASTEUR
75NOVARTIS VACCINES AND DIAGNOSTICS
40EMERGENT BIOSOLUTIONS
14PAXVAX
12TEVA PHARMACEUTICALS
12PROTEIN SCIENCES CORPORATION
9PFIZER\WYETH
4BERNA BIOTECH, LTD.
4SMITHKLINE BEECHAM
3INTERCELL AG
1MEDIMMUNE VACCINES, INC.
1CSL LIMITED

COVID19 Lot Number

VAX LOT Total
2S9CL7,949
7,473
2,547
1,506
1,187
1,051
1,049
s0294561,043
866
IMM209861
816
UT7065MA766
657
579
U62828AA563
557
538
U6737AA516
515
S034636506
4F472471
458
P100253275449
444
276563436
429
418
4BH32414
MENVEO404
PP9L5362
UJ446AA337
319
306
290
271
49TM3270
R1B252M253
4F472179
933622147
C5763AA144
CW3116134
3Y7NL126
UNK114
113
ARBA141A105
104
103
96
300057A90
79
1F4EB73
R1B743M62
56
UJ090AA55
51
UH894AB46
45
UNK44
UNK42
42
EJ168638
Unknown36
35
34
32
32
26
el128424
24
A115A22
22
EN620222
21
UNK20
20
19
Z127A19
19
17
JEV18K95E15
12
111798PI12
10
A739088
No batch number8
3333324181078
6
6
TAR356
5
5
U6935AA5
UNK5
4
unknown4
3
2
55RB72
2
2
2
2
2
U7124AA2
JEV18A68E2
2
ABYB05BA1
1
1
1
1
AMVA436A1
1
1
TJ3521
A130A; VIS give1
1
U7140BB1
1
1
SP UP016AA1
1
1808P08802/ESV01
037K20A300,947
EL1284288,578
57,766
1,432

Incidents per State

State Total
82,750
CA62,821
FL38,209
TX36,512
NY34,921
PA23,646
IN23,622
IL20,597
MI19,590
OH19,426
NJ18,413
NC16,769
GA15,932
WA15,351
VA15,234
MA14,876
AZ14,206
MN12,940
MD12,656
CO11,908
WI11,425
MO10,240
TN9,685
OR8,768
KY8,437
CT8,300
SC6,700
OK6,293
AL5,692
LA5,025
IA4,825
KS4,821
UT4,637
NV4,374
NM3,967
AR3,807
ME3,161
NH3,096
NE2,918
MS2,859
ID2,785
WV2,469
HI2,459
PR2,417
MT2,414
RI2,076
DE1,868
AK1,830
VT1,734
DC1,715
ND1,388
SD1,269
WY866
GU118
VI69
AS47
MP29
MH8
XB6
FM4
QM3
XV2
XL1

ID: 1812426
Sex: F
Age:
State: CA

Vax Date:
Onset Date: 05/06/2021
Rec V Date: 10/23/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 037K20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Dysphagia, Epiglottitis

Symptoms: pain in the arm; she had some tiredness soon; This is a spontaneous report from a contactable consumer (patient herself). A 74-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunisation (at the age of 74years). Medical history included ongoing bladder infections and ulcer in her vaginal area. Concomitant medication(s) included estrogens conjugated (ESTROGENS CONJUGATED) taken for an unspecified indication. The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation, Premarin Vaginal cream and Estradiol Vaginal Cream 0.01%. On 06May2021, the patient experienced pain in the arm and, she had some tiredness soon on an unspecified date in 2021. Patient stated, she was using Premarin Cream. She used it last night and this morning when she urinated it smelled like formaldehyde. It stays like that for some time. She has had bladder infections and then thought something was wrong. She talked with her nurse who asked what medications and cream she was using. Then patient made the connection when she used it last night and it smelled like that this morning. Patient and her friend had the shot about 50 days ago. Her friend complained a day or so ago that her arm was hurting and then complained her elbow was hurting yesterday. She didn't think it was related to the vaccine. Then this morning patient's arm was hurting. She clarified shot as Pfizer COVID19 Vaccine and asked if arm pain that long after the vaccine been reported. Urine smelled like formaldehyde: started this morning, but it has happened in the past. It has been going on for 2 weeks since she started using it again. She had used Premarin before and stopped and went to another cream. She doesn't remember any side effects with the other cream. The other cream cost twice as much as Premarin. She states this has been an on going problem. She didn't want to use Premarin before and can't remember why. The Premarin cost 45 and the other cream is 90. Patient clarified the other cream she used was Estradiol Vaginal Cream 0.01%. She used Estradiol and had no issue at all. She bought two tubes and they last 6 months to a year each. Then she stopped using it because she didn't want to spend the money. The outcome of both the events was unknown. Follow up attempts are completed. No further information is expected.

Other Meds: ESTROGENS CONJUGATED

Current Illness: Bladder infection (verbatim: Bladder infections)

ID: 1812427
Sex: M
Age:
State: NY

Vax Date: 04/16/2021
Onset Date: 04/16/2021
Rec V Date: 10/23/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025L20A
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Anxiety, Dyspnoea

Symptoms: Made him hyperallergic to things that he was a little allergic to; Tracheitis; Throat tightening with difficulty breathing; Throat tightening with difficulty breathing; Swelling in the neck area; Fatigue; Dry cough; This is a spontaneous report from a contactable consumer (patient himself). A 40-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Unknown, Expiration date: Unknown), via an unspecified route of administration in Left arm on 16Apr2021 at 12:50 as dose 1, single (at the age of 40-years-old) for COVID-19 immunization. The patient did not receive any other vaccine within 4 weeks prior to the COVID-19 vaccine. The patient had no history of all previous immunization with the Pfizer vaccine considered as suspect. The vaccine was administered in College. The patient's medical history included ongoing asthma diagnosed 30 years ago and Shelfish allergy from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On 16Apr2021, the patient experienced swelling in the neck area, fatigue, dry cough and throat tightening with difficulty breathing. On 19Apr2021, the patient experienced tracheitis. The patient made him hyperallergic to things that he was a little allergic to on an unspecified date. It was reported that he had an adverse reaction on the first shot 3 weeks ago. He states that after the first shot he got swelling in the neck area initially then difficulty breathing began hours after the injection. He stated that maybe 3, 4 or 5 hours after the vaccine but was not sure of the exact number of hours. He stated that he had been to Physician office visit. He stated steam in the shower or vocalization and that those start inflammation of his throat again. Reporter stated that his doctor diagnosed him with tracheitis. He stated that he took the vaccine on Friday at 12:50 pm and saw the doctor on Monday at 10:15 am where he was diagnosed with acute tracheitis. He stated that he had been to an allergist and an ENT doctor a few days ago. He said that he had a flare up yesterday and has progressively gotten less severe and triggered less inflammation in throat and difficulty breathing. Reporter stated he had been coughing to get throat open. Reporter stated that he has not been cognizant of it since that time. He states that he doesn't mean that the swelling hadn't happened, but he was more focused on the inside the throat. He said that a half an hour to an hour later his throat started to tighten. He stated that he got triggered by certain stimuli, steam and vocalization, and rubbing the area. He stated he could reproduce the issue if he rubbed the area. He stated that the frequency had decreased, and in that case, it had improved. He stated that when it does occur it felt pretty similar to the initial time. He had fatigue first then probably a half an hour to an hour later the swelling started. He believed the fatigue had gone away, but not 100 percent sure. He stated that there were times he had felt fatigue and was not 100 percent of the cause. He stated that if he did felt fatigue, he assumed it because of the tracheitis. He stated that the coughing is parallel with the throat tightening. When he wanted to open his airway or pass way the coughing seems to occur. He stated he got relief or a more open passage way and the coughing reflex or coughing bouts are less. When he got the tightness of the throat or the inflammation, he sort of goes into coughing. It was reported that the symptoms lasted 25 days after the shot and made him hyperallergic to things that he was a little allergic to and he is getting throat tightening with those things. The outcome of the events swelling in the neck area, dry cough, tracheitis and throat tightening with difficulty breathing was not recovered. The outcome of the event fatigue and made him hyperallergic to things that he was a little allergic to was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness: Asthma (Verbatim: asthma Diagnosed 30 years ago)

ID: 1812428
Sex: M
Age:
State: FL

Vax Date: 05/04/2021
Onset Date: 05/01/2021
Rec V Date: 10/23/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot: EL1284
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Chest discomfort, Dysphagia, Pain in extremity, Visual impairment

Symptoms: blisters on different areas- arms, legs, chest and some on his back/get blisters all over his body; Has dry skin; Skin is itchy but not sure if its from the blisters; chest is the worst part of it and he has bad scars left from them; This is a spontaneous report from a contactable consumer. This consumer (patient) reported for himself that, A 85-years-old male patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot Number: EW0172) (at the age of 85 years old), dose 2 via an unspecified route of administration, administered in arm left on 04May2021 as dose 2, single for covid-19 immunisation (age at the vaccination 85-years-old). Historical vaccine, the patient took first dose bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot number: EB8737), dose 1 via an unspecified route of administration administered in arm left, on 04Apr2021 as dose 1, single for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. Patient's first dose was on 04Apr2021, and he developed blisters on his chest that lasted for a month and did not resolve before receiving the second dose. He received his second shot on 04May2021. On an unspecified date in May 2021, he had blisters on different areas arms, legs, chest and some on his back. His chest was the worst part of it and he had bad scars left from them. Some were berry small and some were quite large, smaller than a penny about half an inch by quarter inch. The small ones were like a ball point pen. He had dry skin and tried to keep lotion on them. Skin was itchy but not sure if it was from the blisters. He also had one blister on his arm and one on his leg. He has burst some, but he saw his doctor told him not to burst anymore and was prescribed some cream that he still had to pick up from the pharmacy. He saw his family doctor and he couldn't find any reason why they would be developing. Treatment for the events was received. There was no history of all previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines administered on same date of the Pfizer suspect. There was no prior vaccination within four weeks. The relevant tests were reported. The outcome for the events were unknown. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1812429
Sex: F
Age:
State: NJ

Vax Date: 05/01/2021
Onset Date: 05/02/2021
Rec V Date: 10/23/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: unknown
Dose Series: UNK
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: Extremely fatigue for 4 days; Heavy sweats; Loss of appetite; Headache; Dizzy; Continuing vertigo for longtime today is 5th day; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0176) via an unspecified route of administration in the left arm on 01May2021 at 15:00 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history and known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the left arm on 10Apr2021 at 15:00 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. On 02May2021 at 07:00, the patient experienced extremely fatigue for 4 days, heavy sweats, loss of appetite, headache, dizzy and continuing vertigo for long time, today was 5th day (at the time of this report). The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event extremely fatigue for 4 days was resolved on 06May2021 at 07:00. The clinical outcome of the events heavy sweats, loss of appetite, headache, dizzy and continuing vertigo for long time today was 5th day was not resolved at the time of this report. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1812430
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/23/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth

Symptoms: Injection site soreness; Ache behind the eyes and like a sinus headache; It went down to the neck, shoulder and back and have whole body pain.; It went down to the neck, shoulder and back and have whole body pain.; It went down to the neck, shoulder and back and have whole body pain.; It went down to the neck, shoulder and back and have whole body pain.; This is a spontaneous report received from a contactable consumer or other non-healthcare professional (Patient). A 58-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunisation. Medical history included he lost his eye sight in service from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown) via an unspecified route of administration on an unspecified date (at the age of 58-years-old) as dose 1, single for COVID-19 immunisation and experienced injection site soreness. After the 2nd Pfizer covid vaccine patient had injections site soreness and 12 hours after in the middle of the night I started to ache behind the eyes and like a sinus headache then it went down to the neck, shoulder and back and have whole body pain on an unknown date. 10 hours after it began about 24 hours after the injection treatment was received for the events as 400 mg of ibuprofen without thinking about it. to minimize the aches and pains. Now patient worried he blunted the efficacy of the vaccine. Patient took the ibuprofen 24 hours after received the vaccine, 12 hours after had some symptoms. Patient took it 24 hours after the vaccination, 12 hours after the onset of symptoms. The outcome of the events was reported as unknown. Description of complaint: Caller stated that 12 hours after symptoms he took ibuprofen and he didn't consider how it may blunt or depress the immune response. If it blunted or adversely effected the immune response to the vaccination. He has concerns about the actual level of immunity developed from the second dose and if it may have blunted the effects. No follow up attempts are needed, No further information is expected.

Other Meds:

Current Illness:

ID: 1812431
Sex: F
Age:
State:

Vax Date: 05/04/2021
Onset Date: 05/05/2021
Rec V Date: 10/23/2021
Hospital:

Vax Type: FLUC4
Manufacturer: SEQIRUS, INC.
Vax Name: INFLUENZA (SEASONAL) (FLUCELVAX QUADRIVALENT)
Lot: 276563
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Chills, Confusional state, Eye inflammation, Headache, Laboratory test

Symptoms: Severe chills; Severe headache; Severe nausea; Emesis; Mild myalgia; Moderate to severe fatigue; This is a spontaneous report from a non-contactable consumer, the patient. A 33-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 04May2021 at 13:00 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. Medical history included known allergies to non-steroidal anti-inflammatory drugs (NSAIDs). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medications. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 05May2021 at 05:00, the patient experienced severe chills, severe headache, severe nausea, emesis, mild myalgia and moderate to severe fatigue. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of the events which included treatment with paracetamol (TYLENOL) and bed rest. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event's severe chills, severe headache, severe nausea, emesis, mild myalgia and moderate to severe fatigue were not resolved at the time of this report. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1812432
Sex: F
Age:
State: FL

Vax Date: 05/10/2021
Onset Date: 05/10/2021
Rec V Date: 10/23/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Pyrexia, White blood cell count decreased

Symptoms: This morning she reports having an a feeling like a hair caught in her throat or how your throat feels when you need to cough up phlegm; This morning she reports having an a feeling like a hair caught in her throat or how your throat feels when you need to cough up phlegm/feeling in back of throat like a hair is stuck in the back of it; Sore arm; Nauseous; light sensitivity; super tired; eyes were itchy, on and off.; she didn't feel good; she felt itchy all over and it would come and go from one part of her body to the next/eyes were itchy, on and off. Then, she would get an itch in her ear, then her leg, then her head and face; she noticed a non-itchy rash on her forearm on the same arm as the injection was given and reports it comes and goes.; her anxiety just gets worse; This is a spontaneous report from a contactable consumer (patient). A 34-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EW0168, and Expiration date: Unknown), via an unspecified route of administration, administered in left arm on 10May2021 10:00 (at the age of 34-year-old) as dose 1, single for COVID-19 immunization. The patient medical history included ongoing anxiety (she was diagnosed with anxiety maybe 8-10 years ago), allergic to alcohol beverages (ongoing, she did she test it on a shot of Tequila and did end up getting very bad symptoms), intolerant to the sulfites (her doctor thinks she is intolerant to the sulfites), sensitive skin, and smoking cigarettes for 20 years. She did not have a history of catching pneumonia or anything. The patient previously received tetanus shot years back. There were no concomitant medications. No investigation assessment was done. No history of all previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines administered on same date of the Pfizer suspect. No prior vaccinations (within 4 weeks). It was reported that, the patient, who had a history of sensitive skin, received her first injection of the Pfizer COVID-19 vaccine at 10:00 on 10May2021. She felt fine afterwards and stayed 30 minutes for monitoring before going home. After getting home, she felt itchy all over and it would come and go from one part of her body to the next. She further described as her head would itch and then it would move to the arm later. She stated that she had no rash at that time. On 10May2021, around 09:00 PM, "she noticed a non-itchy rash on her forearm on the same arm as the injection was given and reports it comes and goes". She said the rash was further down, like on her forearm, it was not itchy, it would just come and go. On 10May2021, the patient felt super tired, maybe an after receiving the vaccine. Right when she got the vaccine, she felt a little nauseous. The nausea when it first happened went away when she turned her car on and caught a little air. She had a lot of symptoms. She added the symptoms she was mentioning are the "scary ones" that were making her freak out, however she knew the tiredness was normal. She did have light sensitivity, which she did not know if that was a symptom. However, she noticed when she got out of her car (it was super sunny out), it was like she could not even open her eyes. She clarified she was able to open her eyes, but the sunlight was so much brighter than it normally was. She went out to eat around 02:00 PM and after she finished eating, she felt super nauseous, but she did not know if she ate too much. All she wanted to do was to close her eyes because she was so tired, and she didn't feel good. She was so tired. She got home at 04:00 PM and fell asleep at 05:30 PM, she woke back up around 10:00 PM. She took a very long nap. Normally, if she took even like a 2 hour nap during the day, it was still hard to fall asleep that night, but she ended up falling back asleep at like 11:00 PM on 10May2021 night. She was only awake for like an hour after taking her nap before she went back to sleep and then she woke up at 07:00 AM the next morning. She did not really pay attention to her arm throughout the day like when she went out to lunch and stuff because the itchiness was not happening too much. However, she noticed the rash when she woke up from her nap at 10:00 PM on 10May2021. The rash went away 20 minutes after- she went to go look again to see if the rash was worse and the rash disappeared. The patient sated on 10May2021, she had sore arm. She explained the arm soreness did not happen right way after the vaccine, it started between 04:00 and 05:00 PM. On 10May2021, her eyes were itchy, on and off. Then, she would get an itch in her ear, then her leg, then her head and face. She states it was so annoying and it was throughout the whole night. The patient stated she did not want to take a Claritin because she did not want to stay up all night. When she woke up in morning, the rash came back again on 11May2021, so she did take a Claritin, so the itchiness was kind of calming down a little bit and the rash just went away. She had a little bit of itching but was not as bad as it was on 10May2021 (last night). On 11May2021, "this morning she reports having an a feeling like a hair caught in her throat or how your throat feels when you need to cough up phlegm/feeling in back of throat like a hair is stuck in the back of it". She described it as the feeling you get when you need to clear your throat because it had mucus in it. The patient stated that the thing that was freaking her out was the feeling in the back of her throat. Since she left her house this morning around 07:30 until the time of reporting, she did not see the rash on her arm. She tried to look around her whole body but she did not see anything. She does see something on her stomach, but she did not know if that was just her freaking out. She explained she did have sensitive skin and "sometimes when she sprays perfume it goes through her shirt, and her stomach will get a little red". The patient said, definitely the rash on her arm was from the vaccine because she never got anything on her arm. The patient explained she felt a little tired. However, she did not know if it was from the vaccine or if it was just an every day tiredness. She was usually never that tired. The last time she felt that tired was when she was pregnant. That tiredness was not normal for her. She confirmed the tiredness was still ongoing but it had improved. The nausea was still ongoing and persisting. She did not know if it was because she was thinking so much about this, but she was not feeling to well. She was super anxious. She compared the itchiness to when like "when one little bug is on you for a second, and then for the whole day your body is itching and freaking out, thinking there is a bug on you". However, the feeling in her throat was concerning her. She was thinking to herself "oh my gosh, am I going to die?" That was all that was going through her head. She did not know if it was her anxiety kicking in, but she was starting to feel super nauseas. The patient added, "it sucks living with anxiety, freaking out over any little health condition, she hates it". She stated on an unknown date in 2021, her anxiety just gets worse. No relevant tests were performed. The patient was scared to take second vaccine. The patient was asking if it was normal to have non itchy rash looking thing on the arm that she got the injection which was the left arm like you know where the forearm was like the bottom part of your arm. The patient was scheduled second vaccination dose on 31May2021. The outcome of events pruritus, rash, pain in extremity, nausea, and fatigue was reported as not resolved. The outcome of events productive cough, oropharyngeal discomfort, photophobia, eye pruritus, malaise, and anxiety was unknown. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness: Alcohol allergy (she did she test it on a shot of Tequila and did end up getting very bad symptoms.); Anxiety (Verbatim: Anxiety she was diagnosed with anxiety maybe 8-10 years ago)

ID: 1812433
Sex: M
Age:
State:

Vax Date: 04/29/2021
Onset Date:
Rec V Date: 10/23/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: UNK
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Pharyngeal swelling

Symptoms: muscle pains; Light headedness/light headed; scratchy throat; cough; sore throat; chills; Body aches; flu like symptoms/he is sick or has a virus, not Covid, but like getting the flu or something; This is a spontaneous report from a Pfizer sponsored program via a contactable consumer (patient's wife). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Not reported, Expiration date: Unknown), via an unspecified route of administration on 29Apr2021 as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Not reported, Expiration date: Unknown), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. The patient experienced muscle pains, light headedness or light-headed, scratchy throat, cough, sore throat, chills, body aches, flu like symptoms and he was sick or had a virus, not COVID, but like getting the flu or something on an unspecified date. It was reported that the patient developed symptoms 9-10 days after he received his second dose of the Pfizer COVID-19 vaccine. The outcome of the events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1812434
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/23/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Abdominal pain, Chills, Sleep disorder

Symptoms: Muscle pain; Joint pain; Back pain; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiration date not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced muscle pain, joint pain, and back pain. As reported clinical course: Patient was wondering how long pain will last. She says that she called about a week ago. She wasn't aware that muscle and joint pain were associated with the Covid Vaccine pretty strongly. States that some of the pain was continuing, the joint pain was gone. States that the severe back and joint pain scared her so much. She found out it was normal. Her Nurse Practitioner said that the pain could be present for up to 3 weeks. States that if other people aren't effected like she has been they think it was all in the person's head. States she has been having to work through her pain as they are testing at school now and she cannot take off. She was also wondering what was in the vaccine that causes this side effect. This report was not related to a study or programme. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1812435
Sex: F
Age:
State: VA

Vax Date: 03/31/2021
Onset Date: 04/01/2021
Rec V Date: 10/23/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011J201A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data: Test Name: Blood work; Result Unstructured Data: Test Result:Normal; Test Name: Chest X-ray; Result Unstructured Data: Test Result:Normal; Test Name: EKG; Result Unstructured Data: Test Result:Normal; Test Name: Antibody blood test; Test Result: Positive

Allergies:

Symptom List: Diarrhoea, Nasal congestion

Symptoms: Blood pressure has been higher; Predominantly chest pain for which cardiac issues have been eliminated; This is a spontaneous report from a contactable consumer (patient herself). A 43-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number and expiration date was not reported) via an unspecified route of administration, administered in Arm Left on 31Mar2021 15:30 (at the age of 43-years-old) as DOSE 1, SINGLE for COVID-19 immunization. Medical history included ongoing rheumatoid arthritis; diagnosed probably 10 years ago, costochondritis; caller stated they diagnosed her with costochondritis, and she has had it before, myocardial infraction and neoplasm malignant from an unknown date and unknown if ongoing. Family medical history relevant to AE(s): Grandfather died young from heart attack. States her mom was never healthy, but she did not know if that was related and she did not have any problems with Pfizer vaccine. Caller stated they have the typically cancer and stuff. Concomitant medication included adalimumab (HUMIRA) taken for rheumatoid arthritis from 2017 and ongoing. Humira: supposed to do every other week but she does it every month and okayed with rheumatologist. Past 6 Years; Past 4 years been spacing it out. Summer she did 5 weeks, winter 4 weeks. Tried to go off. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. AE(s) following prior vaccination was reported as none. Patient received the 1st dose of the Pfizer COVID vaccine on 31Mar2021, but has complained of side effects since, predominantly chest pain on 01Apr2021for which cardiac issues have been eliminated. Caller was being followed by a Rheumatologist and was being treated for the symptoms. Caller wanted to know. Caller enquired if she just get the one shot and not the other, what would the efficacy of one dose. The chest pain was not as bad, but it has been 7 weeks and she had not gotten her second shot because she has not been up to it. Caller was asking for additional information about her chest pain and if it was normal to still have it 7 weeks later and guidelines on the second vaccine. Caller stated the chest pain was pretty awful and probably the worst she had ever felt. Stated she could especially feel it when she would cough, sneeze or breathe. Caller Stated she was not sure if it was from the vaccine or her autoimmune disorder on overdrive with having the vaccine in her body because it was not something it is used to. Caller states sometimes her blood pressure has been higher, but she thought it was because she was stressed out. Caller Stated she went to an urgent care on 04Apr2021 and it her blood pressure was elevated and she went back again and they did not say anything, so she assumed it was better. Caller stated her heart looked fine. AEs resulted in emergency room and physician office visit. Emergency Room/Urgent Care 04Apr2021 and back for a follow up that Friday 10Apr2021. Treatment- gave muscle relaxers, prednisone dose pack, lots of Advil. Prednisone came after her rheumatologist appointment on 21Apr2021. Caller states her blood work showed COVID antibodies. Caller asked whether that means she had COVID or not or whether they were from the vaccine?. Caller stated she was a vegan, healthy, and she was in good shape. Caller states she took Humira the week before the shot. The patient underwent lab tests and procedures which included blood test, electrocardiogram and chest x-ray which was normal, SARS-COV-2 antibody test: positive on an unspecified date. This report was not serious. The outcome of event predominantly chest pain for which cardiac issues have been eliminated was resolving while outcome of blood pressure has been higher was resolved on an unspecified date in Apr2021. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds: HUMIRA

Current Illness: Rheumatoid arthritis (Diagnosed probably 10 years ago)

ID: 1812436
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/23/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data: Test Name: blood pressure; Result Unstructured Data: Test Result:unknown; Test Name: Covid test; Test Result: Negative

Allergies:

Symptom List: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling

Symptoms: experiencing shortness of breath; cough; This is a spontaneous report from a contactable consumer or other non-health care professional reporting for wife (Patient). A 27-year-old female patient received bnt162b2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection and Batch no/ Lot number: not reported) via an unknown route of administration on an unspecified date as dose 1, single for covid-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date, patient experienced with shortness of breath and cough together, after her 1st dose of the vaccine 10 days before. Patient went to the doctor for the resulted events, and she tested for the Covid. Patient did not have these problems until she received her vaccination was reported as no. Investigation Assessment was not provided. On an unknown date, patient underwent lab tests and procedure which were evaluated blood pressure test with unknown results and a COVID test results negative for Sars-cov-2. Reporter mentioned that patient did not have these problems until she received her vaccination. They are evaluating a possible respiratory problem, but it was still too early to conclude. Patient was asking whether the reported events were side effect of vaccine. The outcome of the events was unknown. No follow-up attempts are needed; Information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1812437
Sex: F
Age:
State: NJ

Vax Date: 05/08/2021
Onset Date: 05/09/2021
Rec V Date: 10/23/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 039k20a
Dose Series: 1
Vax Route: SYR
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Rash, Urticaria

Symptoms: extremely nauseous; short of breath; Very lightheaded/dizzy; feeling terrible; pain in her neck and jaw; pain in her neck and jaw; This is a spontaneous report received from a contactable consumer (patient). A 52-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; formulation: Solution for injection, Lot Number: unknown), via an unspecified route of administration on 08May2021 (age at vaccine 52-years-old) as dose 1, single for covid-19 immunization.The patient medical history and concomitant medications was not reported. On 09May2021, the patient experienced Very lightheaded/dizzy, very short of breath, extremely nauseous and on unknown date in 2021, the patient experienced pain in her neck and jaw, feeling terrible. It was reported that patient have been feeling terrible, extremely nauseous, short of breath, dizzy and reported pain in her neck and jaw. she was asking if she needs to go to the emergency room as she was not the type of person to seek medical attention even when she previously tore her ACL. she did not have a primary care provider. She referred to vaccination Provider or urgent care for additional guidance as caller stated she did not have a primary care provider she reported that she was one of those people that would like her death to be a surprise, so she doesn't go to the doctor or the emergency room. She stated that she does not know if this was something that was normal or if she should go to the doctor. The clinical outcome of the events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1812438
Sex: F
Age:
State: RI

Vax Date:
Onset Date:
Rec V Date: 10/23/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data: Test Name: serum antibody test; Test Result: Negative

Allergies:

Symptom List: Blood pressure decreased, Chest pain, Chills, Confusional state, Decreased appetite

Symptoms: loss of taste; loss of smell; She had full sickness for an entire week; Water even tasted like minerals; sore throat and then it started going into her lungs; malaise; diarrhea; swollen glands in neck and tongue; This is a spontaneous report received from a contactable consumer (patient). A 73-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number, NDC number were not reported) via an unspecified route of administration on an unspecified date in 2021 (at the age of 73-years-old) as dose 1, single for covid-19 immunisation. Medical history includes that she had covid-19, 17 months ago in December/January, more than a year ago. She was one of the first people to have it. Nobody knew what it was. She stayed home and was extremely sick. She had it in her lungs so bad, she lived alone, and could not call for help. She could not manage more than a whisper. She could not get air across her voice box. She toughed it out and used her homeopathic remedies. It got better little by little and she got over it. In March, when she found out what it was. She lost her taste and smell and could not eat and got diarrhoea for 3 days and then she was flying home after the holiday beginning in January and started feeling a sore throat and then got her lungs. She got lungs so bad that after that was getting better, she was coughing so hard to get it out of her lungs. Her symptoms were the same as what she heard about in March. She did not go to the doctor. She should have gone to the hospital, and she would have gotten a ventilator and would have died. Six months later, she had a serum antibody test done to see if she had it because her doctor did not believe her, and he said to take a test and it was negative. No discernible amount could be seen in antibodies, but the test also said that antibodies could be hiding in her body if she had it and her doctor did not believe her because it was negative. The patient concomitant medications were not reported. She had her first Pfizer covid vaccine two and half weeks ago. On an unspecified date in 2021, the patient had full sickness for an entire week. She thought she still had antibodies in her and that was what she was reacting with. It was not as bad as how it was the first time. It so happened the shot was on Thursday, and she did not feel well on Saturday. There was a delay. Thursday into Saturday, two days later, food tasted funny. She thought what is wrong with food. Water even tasted like minerals. And then the next day, she had diarrhoea. The third day, she had a sore throat and then it started going into her lungs. She was using her homeopathic stuff and she stopped it dead and did not get pneumonia. She had malaise, she was sick, but it was not severe. It was a very similar reaction. About two days after Pfizer vaccine, she had loss of taste, smell, diarrhoea, swollen glands in neck and tongue then the symptoms stopped before going to lungs due to her taking homeopathic remedies, symptoms lasted 4-5 days. She thought what she needs to know is what is in the first vaccine that makes the second one different from the first. Normally, the first shot sets people up for a reaction after the second shot. She stated that this should be expected after the second shot. She wanted to know if it is different if she had Covid before. Her concern was does she need the second shot if she already had the immune boost that happens. She was schedule for the second dose. The patient underwent lab tests and procedures which included antibody test and result was negative on an unspecified date. The outcome of the events loss of taste, loss of smell, diarrhoea, lymphadenopathy was recovered in 2021 and for all other events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information expected.

Other Meds:

Current Illness:

ID: 1812439
Sex: F
Age:
State: MA

Vax Date: 05/08/2021
Onset Date: 05/08/2021
Rec V Date: 10/23/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025J20-2A
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Dyspnoea, Fatigue, Feeling abnormal, Head discomfort, Headache

Symptoms: Rash/Rash and Itching all over her skin was reported as worsened; Itching/Rash and Itching all over her skin was reported as worsened; Skin is very irritated/Skin is very irritated was reported as worsened; Kind of an allergic reaction; This is a spontaneous report from a contactable consumer (patient's mother) reported for a patient (reporter's daughter). A 17-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: ER8736, Expiration date: unknown) via an unspecified route of administration, administered in right arm on 08May2021 at 09:30 am (age at vaccination was 17 years) as dose 2, single for COVID-19 immunization. The patient did not have any medical history. The patient's family history relevant to adverse event included the patient's mother had asthma. Concomitant medications included naproxen sodium (ALEVE), paracetamol (TYLENOL) and gramicidin, neomycin sulfate, polymyxin b sulfate (NEOSPORINE) all taken for an unspecified indication. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EW0153, Expiration date: unknown) via an unspecified route of administration, administered in right arm on 17Apr2021 (age at vaccination was 17 years) as dose 1, single for COVID-19 immunization and had no reaction after the first dose of the COVID 19 Vaccine. No additional vaccines were administered on same date of the Pfizer suspect. The facility where the most recent COVID-19 vaccine was administered was Community Center. The vaccine was not administered at other Facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 08May2021 about 11:00 am to 12:00 pm, about an hour or two after the vaccine the patient complained of itching and got a rash later that day. The patient had rash and itching all over her skin. Rash and itching all over her skin was reported as worsened. It had gotten worse over time. It was not severe. On 08May2021, the patient's skin was very irritated and the patient had a kind of an allergic reaction. The patient woke up that morning with complaints of the skin irritations being worse. Skin was very irritated was reported as worsened. It was not critical, the patient's skin was just very irritated. Prior to the second dose of the COVID 19 Vaccine the patient had no itching or rashes. She was trying to find information on skin reactions but could not find any information. She wanted information on this and how long it lasts and what to do about it. The patient was referred to HCP for further discussion and treatment recommendations. The reporter denied any medications, medical conditions, labs, testing or treatments for the patient that are relevant to these events. The adverse events did not require a visit to Emergency Room or Physician Office. No relevant tests were done. The outcome of the event kind of an allergic reaction was unknown. The outcome of the other events was not resolved. No follow-up attempts are needed. No further information is expected

Other Meds: ALEVE; TYLENOL; NEOSPORINE

Current Illness:

ID: 1812440
Sex: M
Age:
State: CA

Vax Date: 03/04/2021
Onset Date: 03/04/2021
Rec V Date: 10/23/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data: Test Name: Corona IGG; Result Unstructured Data: Test Result:negative; Comments: The first was an ABIGG, SPIKE S and the reading was a little arrow to the left less than 1.; Test Name: Sars Covid 2 IGG spikes; Result Unstructured Data: Test Result:negative; Comments: The second antibody test he had done was a CoV-2 IGG/IGM and the little arrow read to the left of 1.4. and then later were 0.04 and 0.02 readings.

Allergies:

Symptom List: Heart rate decreased, Heart rate increased, Hypertension, Injection site pain, Musculoskeletal chest pain

Symptoms: little lightheaded; tired; This is a spontaneous report from a contactable consumer via medical information team. A 76-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/ lot number was not reported), via an unspecified route of administration on 04Mar2021 as dose 1, single for COVID-19 immunization. The medical history included chronic lymphocytic leukaemia (CLL), he was diagnosed 14-15 months ago with CLL and had been taking Imbruvica 420mg/day. His WBC count was 16K and was 50-60% lymphocytes but now his bloodwork was good and controlled by Imbruvica. He also had dental, orthopaedic and heart issues. He had a spleen that was measuring 22cm and was pushing his stomach out. He then moved from to a private doctor and had moved from Stage 2 to Stage 0. He had had no side effects from the Imbruvica. The patient's concomitant medications were not reported. On 04Mar2021 after the first shot the patient felt a little lightheaded and then tired the same day. He also received his second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/ lot number was not reported) on 24Mar2021. On an unspecified date the patient underwent lab tests and procedures which included immunity test to check if he gained immunity to the shots like Corona IGG /Sars Covid 2 IGG spikes both came out negative. The first was an ABIGG, SPIKE S done two weeks after the vaccine and the reading was a little arrow to the left less than 1. His doctor told him that this only shows recent infection. The second antibody test he had done four weeks after the vaccine was a CoV-2 IGG/IGM and the little arrow read to the left of 1.4. and then later were 0.04 and 0.02 readings. The outcome of the events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1812441
Sex: F
Age:
State: SC

Vax Date: 04/05/2021
Onset Date: 04/01/2021
Rec V Date: 10/23/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Nausea, Pain, Pain in extremity, Paraesthesia oral, Pyrexia

Symptoms: she developed a chemical smell and taste; she developed a chemical smell and taste; can't taste her food, and everything smells the same; This is a spontaneous report from a contactable consumer or healthcare professional Nurse (patient). A 63-years-old female patient received first dose of BNT162B2 (Pfizer-BioNTech Covid-19 Vaccine, formulation: solution for injection, lot number: EW0150, expiry date: unspecified date in Jul2021) via unknown route of administration in left arm on 05Apr2021 at 16:30 (at the age of 62 years old) as DOSE 1, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medication were reported. She stated that she quit taking any other medications to try and rule them out, and she had not yet restarted those other mediations, so she was sure that this event had to be from the vaccine. It was reported that a couple of days after her 1st dose, she developed a chemical smell and taste. She stated that she cannot taste her food, and everything tastes the same on an unspecified date in Apr2021. She said this reaction was still ongoing. Like her bowel movements smell the same as her coffee, same as toothpaste and food. She was wondering how long this would last and if other people have had this side effect. It was reported that if this was a known side effect, then it should be listed on the list of side effects, because it was not on the papers she was given. It was reported that the reporter wanted to know if this was a known side effect of the vaccine, and how long it lasts. She said she had heard of it happening to other people. she got it because of the pressure that she would have to have it in order to travel places, and because she has friends who were concerned to not be around anyone who did not have the vaccine. It was stated that she was frustrated about it because she had not planned for this to occur, it was not life threatening in any way, but if she was going to have this for the rest of her life, she wanted to know it now and said she may need to get herself a tongue and nose transplant. The patient had no other vaccines on the same day as the suspect product and did not receive other vaccines Prior Vaccinations (within 4 weeks). The patient did not visit Emergency Room or physician office due to events. It was reported that the event can't taste her food, and everything smells was related to product. The outcome of the event can't taste her food, and everything smells the same was not recovered and other was unknown. Follow up attempts were completed. No further information was expected

Other Meds:

Current Illness:

ID: 1812442
Sex: F
Age:
State: TX

Vax Date: 04/14/2021
Onset Date: 04/15/2021
Rec V Date: 10/23/2021
Hospital:

Vax Type: DTAPHEPBIP
Manufacturer: GLAXOSMITHKLINE BIOLOGICALS
Vax Name: DTAP + HEPB + IPV (PEDIARIX)
Lot:
Dose Series: UNK
Vax Route:
Vax Site: LG

Lab Data:

Allergies:

Symptom List: SARS-CoV-2 antibody test, SARS-CoV-2 test negative

Symptoms: She was so dizzy; pain in her shoulder started; then it went under her arm, a throbbing pain; Then, it shot down to her calf, its weird; Her muscles just ache; she had no strength in her wrist; After the first shot she had a bruise on her arm for week after she got it; Around the second day she experienced head spinning; chest tightness; This is a spontaneous report from a contactable consumer or other non healthcare professional. A 54 year old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 14Apr2021 13:00 (Batch/Lot Number: ER8733) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included hepatitis from an unknown date and unknown if ongoing, Arthritis, Degenerative Joint Disease. The patient's concomitant medications were not reported. The patient experienced around the second day she experienced head spinning causing vertigo on 15Apr2021 with outcome of unknown, chest tightness causing chest discomfort on 15Apr2021 with outcome of unknown, she was dizzy on an unspecified date with outcome of unknown , pain in her shoulder started causing arthralgia on an unspecified date with outcome of recovered , then it went under her arm, a throbbing pain causing axillary pain on an unspecified date with outcome of recovered , then, it shot down to her calf, its weird causing pain in extremity on an unspecified date with outcome of recovered, her muscles just ache causing myalgia on an unspecified date with outcome of recovered , she had no strength in her wrist causing muscular weakness on an unspecified date with outcome of recovered, after the first shot she had a bruise on her arm for week after she got it causing vaccination site bruising on an unspecified date with outcome of recovered. Therapeutic measures were taken as a result of , her muscles just ache, Ointment Capsaicin Deep Penetrating, Odour Free for Arthritis Pain Relief. They gave her Naproxen but, she never took it, Follow-up(11May2021):This is a follow-up spontaneous report from a contactable consumer. This female consumer (patient) reported for herself that: Additional information regarding medical history, adverse events and therapeutic measures taken were added. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1812444
Sex: F
Age:
State: WA

Vax Date: 04/27/2021
Onset Date: 05/01/2021
Rec V Date: 10/23/2021
Hospital:

Vax Type: HIBV
Manufacturer: MERCK & CO. INC.
Vax Name: HIB (PEDVAXHIB)
Lot:
Dose Series: UNK
Vax Route:
Vax Site: LG

Lab Data:

Allergies: Sesame oil

Symptom List: Ear pain, Hypoaesthesia

Symptoms: This is a spontaneous report from a contactable consumer (patient). A 26-year-old (non-pregnant) female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# not reported), at the age of 27, via an unspecified route of administration, in left arm, on Apr 27, 2021, 08:15, single dose, for COVID-19 immunization. The patient's medical history not reported. Concomitant medications included Nexplanon and testosterone. The patient previously took sesame oil and experienced drug hypersensitivity. Reportedly, patient did not receive any other vaccine in four weeks. The patient did not have COVID-19 prior to vaccination, nor tested post vaccination. On May 1, 2021, at 12:00 (patient reported 10 days post vaccine), she still has a lump at vaccination site, arm soreness, headaches almost every day and nausea. The patient did not receive any treatment for the events. At the time of report, the outcome: not recovered from the events. No follow-up attempts possible. Information about batch/lot cannot be obtained. No further information expected.

Other Meds: Nexplanon; Testosterone

Current Illness:

ID: 1812445
Sex: F
Age:
State: PA

Vax Date: 04/27/2021
Onset Date: 04/01/2021
Rec V Date: 10/23/2021
Hospital:

Vax Type: PNC13
Manufacturer: PFIZER\WYETH
Vax Name: PNEUMO (PREVNAR13)
Lot:
Dose Series: UNK
Vax Route:
Vax Site: LG

Lab Data:

Allergies:

Symptom List: Abdominal pain upper, Dizziness, Dysgeusia

Symptoms: was in both hands, that numbing sensation; painful arm, so painful she couldn't even lift it or move it; she could not get up; Nauseous was reported as worsened; the palms of her hands turned very red, it looked like she had a glove on; felt pins and needles in her hands; severe left sided arm pain; arm pain which radiated to her shoulder blades, neck, back under her am/ she feels all painful and achy/ the whole area was so severe; thought the vaccine might have hit a nerve; The shoulder, neck, back, shoulder blade, it just feels like it's burning; severe left sided arm pain which radiated to her shoulder blades; severe left sided arm pain which radiated to her shoulder blades, neck; severe left sided arm pain which radiated to her shoulder blades, neck, back under her am/ upper back; severe left sided arm pain which radiated to her shoulder blades, neck, back under her am, and left breast; This is a spontaneous report from a contactable consumer (patient) reporting herself. A 69-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number EW0169) via an unspecified route of administration, administered in left arm on 27Apr2021 at 14:15-14:30 (age at the time of vaccination was 69-years-old) as dose 1, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. She did not take any medication. No other products were administered. There were no any history of all previous immunizations with the Pfizer vaccine considered as suspect and no additional vaccines administered on same date of the Pfizer suspect. No prior vaccinations within 4 weeks and no any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. No adverse events following prior vaccinations. There was no patient's medical history (including any illness at time of vaccination) and no family medical history relevant to adverse events. No relevant tests. It was reported that, after receiving first dose, the patient has felt pins and needles in her hands. Aside from this, she had severe left sided arm pain which radiated to her shoulder blades, neck, back under her am, and left breast. She was feeling all these stabbing pins and needles in her hands, worse in her left hand. She said this has been going on for 2 weeks now. Nauseous was reported as worsened. She wanted to know if this was a known side effect associated with the Pfizer-BioNTech Covid-19 Vaccine, and if it would go away. Consumer also wanted to know if this might had been caused by the vaccine not being administered properly and did not go into the muscle. She thought the vaccine might have hit a nerve, but she did not that the pins and needles in her hands have already subsided. She stated her hands, the palms of her hands turned very red. She stated it looked like she had a glove on but she experienced such a painful arm, so painful she could not even lift it or move it, it was been severe, it was into her shoulder, neck, shoulder blade, upper back, the whole area was so severe. She stated into the back of her neck, shoulder, her whole back, shoulder blade on left side, under her arm, and into the breast on her left side. She was supposed to go back for another shot, she did not think so. She stated at that point, it was in both hands, that numbing sensation and she was showing to her husband her hands, and he said it looked like she had a glove on. She was trying to stay calm. She told her husband to get back to the car and she had some water so she drank a little bit of water. She sat in the car a little bit and they started to slowly head home and it just continued as far as the arm pain just kept getting worse. It was very painful and had been since the beginning. The pain seemed to get worse every day and went to the neck, back, and shoulder. As far as the redness, that seem like that had gotten better, that had improved. Pins and needles had gotten better. The first week and a half with pins and needles was very bad, but every day, it had started to get a little bit better. She was not having as much, not like it was at all, she was happy about that, that it was improved. The shoulder, neck, back, shoulder blade, it just felt like it was burning. The next day, her husband had to lift her up out of bed, she could not get up. She felt all painful and achy, it was that kind of thing, it came and went. She would say today she had it pretty much on the day of reporting, but she was having a lot of burning in the neck and the back of the shoulder blade, almost like up or down the spine just all over there and the arm and shoulder in the front. She was never even had a flu vaccine but they were vaccinated through childhood for everything but had no real problems with anything. She did not even want to take Tylenol because she did not know what she heard she did not know if she heard they were advising not to take anything like that. She did not visit emergency room and physician office. The outcome of events severe left sided arm pain which radiated to her shoulder blades, neck, upper back under her am, and left breast/ she feels all painful and achy/ she feels all painful and achy/ the whole area was so severe, nauseous was reported as worsened, the shoulder, neck, back, shoulder blade, it just felt like it was burning were not recovered, outcome of events felt pins and needles in her hands, the palms of her hands turned very red, in both hands, that numbing sensation were recovering and outcome of other events were unknown. No follow-up attempts were needed. No further information was expected.

Other Meds:

Current Illness:

ID: 1812446
Sex: F
Age:
State: IL

Vax Date: 10/01/2020
Onset Date: 05/08/2021
Rec V Date: 10/23/2021
Hospital:

Vax Type: RV1
Manufacturer: GLAXOSMITHKLINE BIOLOGICALS
Vax Name: ROTAVIRUS (ROTARIX)
Lot:
Dose Series: 1
Vax Route: PO
Vax Site: MO

Lab Data:

Allergies:

Symptom List: Blood pressure increased, Chest discomfort, Heart rate increased

Symptoms: her lips became dry and the corner is a little dry.; She states her lip is also discolored, being a little darker than usual.; some tingling and a little burning; some tingling and a little burning; This is a spontaneous report from a Pfizer sponsored program COVAX US support. A contactable consumer (patient) reported for that a 67-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection Lot Number: EW0161), via an unspecified route of administration in left arm on 06May2021 at 11:00 (at the age of 67 years old) as dose 1, single for covid-19 immunisation; levetiracetam (KEPPRA), oral from Oct2020 (Batch/Lot number was not reported) and ongoing, at 500 mg, 2x/day, 1 tablet twice a day by mouth for seizure. Medical history included seizure from Oct2020 and ongoing, multiple sclerosis from 1998 and ongoing. The patient's concomitant medications were not reported. The patient previously took keppra for seizure. The patient not had history of all previous immunization with the Pfizer vaccine considered as suspect. The patient did not administer additional vaccines on same date of the Pfizer suspect. The patient did not receive any other vaccines within 4 weeks. She received first dose of the Pfizer BioNTech Covid 19 vaccine last Thursday. Late Saturday afternoon, on 08May2021her lips became dry and the corner was a little dry. They are also having some tingling and a little burning, and still ongoing today. She stated her lip was also discolored, being a little darker than usual. In the corner of her mouth, she thinks she may be developing a cold sore, but she gets those once or twice a year. She also has been on Keppra since October, and she got dry hands from the Keppra. Her second dose was scheduled for 27May2021. He stated late Saturday night the patient started having dryness and itchiness on her neck and she wonders what the problem with this was. She clarified it was not the neck. Stated she has dryness on her lips and a little darkness in the corner of her bottom lip. Therapeutic measures were taken as a result of her lips became dry and the corner was little dry, she states her lip was also discolored, being a little darker than usual with lubricating with vaseline Lip Therapy Tube. No family medical history relevant to adverse events was provided and no relevant tests were performed. The patient did not visit emergency room or physician office. The action taken in response to the events for KEPPRA was unknown. The outcome of events was recovering. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness: MS; Seizures

ID: 1812447
Sex: F
Age:
State: GA

Vax Date: 05/11/2021
Onset Date: 05/11/2021
Rec V Date: 10/23/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot: Eh9899
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site erythema, Injection site pruritus, Injection site swelling, Lymph node pain, Lymphadenopathy

Symptoms: Rash allover her body, upper lip swollen, hands swollen and red, having a lot of itching; Rash allover her body; Upper lip swollen; Hands swollen and red, having a lot of itching; Hands swollen and red, having a lot of itching; Hands are swollen red and hot; She has blisters or hives on her body and everything is red and inflamed and itchy; She has blisters or hives on her body and everything is red and inflamed and itchy; She has blisters or hives on her body and everything is red and inflamed and itchy; She has blisters or hives on her body and everything is red and inflamed and itchy; Both ears are red and swollen and a lot itching; right shoulder, have a lot of pain and can hardly move it; right shoulder, have a lot of pain and can hardly move it; hives, redness and rash in left arm from where I got the shot; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, lot number: EW3344, Expiry date: unknown) (age at the time of vaccination was 58 years), administered in deltoid Left on 11May2021 at 10:00 as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medication was not reported. The patient did not take any other vaccine in four weeks prior COVID -19 vaccine. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: not reported), via an unspecified route of administration, on an unspecified date as dose 1, single for COVID-19 immunization. On 11May2021 at 13:00, after the second dose, the patient started experiencing rash all over her body, upper lip swollen, hands swollen and red, having a lot of itching. The patient received the dose on her left shoulder, but her right shoulder have a lot pain and can hardly move it, and a big red hive, and itching too. The patient had hives, redness and rash in left arm where the patient took the shot and my upper lips were swollen. The patient had different form of lips, because they were so swollen. The patient lips become red, in the back of both legs got itching and hives. The outcome of the events was unknown. No follow-up attempts were needed; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1812448
Sex: F
Age:
State: MD

Vax Date: 05/04/2021
Onset Date: 05/01/2021
Rec V Date: 10/23/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data: Test Name: Blood pressure; Result Unstructured Data: Test Result:Normal

Allergies:

Symptom List: Unevaluable event

Symptoms: tightness in chest; Diarrhea; light headedness; total exhaustion; weird heart palpations; heartburn; sleeping all the time; worse with movement and exertion; This is a spontaneous report from a contactable consumer (Patient) reported for herself that: A 61-years-old female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0172) via an unspecified route of administration, on 04May2021 (At the age of 61 years) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included pericarditis, when she was 19 years old, cardiac disorder, dyspepsia and anaphylactic shock from an unknown date and unknown if ongoing. Concomitant medications included Ipratropium bromide taken for an unspecified indication from 22Apr2021 to an unspecified stop date; Fluticasone propionate taken for nasal drip issues, Mylanta for indigestion, Omeprazole was taken for unspecified indication, hydrochlorothiazide, lisinopril was taken for blood pressure measurement, start and stop date were not reported. On an unspecified date in May2021, the patient had experienced weird heart palpations, worse with movement and exertion, sleeping all the time and heartburn. On 04May2021, the patient had experienced total exhaustion and lightheaded. On 07May2021, the patient had experienced diarrhea. On8 May 2021, the patient had experienced tightness in chest. I am more concerned with the chest tightness because of my history of heart problems and lab test I have been checking my blood pressure and its been within the normal range I just don't know if I should go to the ER. On 09May2021, the event diarrhea was recovered. At the time of reporting, the events weird heart palpation, tightness in chest, light headedness and total exhaustion was not recovered whereas the events worse with movement and exertion, sleeping all the time and heartburn were unknown. No follow-up attempts are needed. No further information is expected.

Other Meds: IPRATROPIUM BROMIDE; FLONASE ALLERGY RELIEF; OMEPRAZOLE; MYLANTA 11; LISINOPRIL + HIDROCLOROTIAZIDA

Current Illness:

ID: 1812449
Sex: M
Age:
State: WI

Vax Date: 04/22/2021
Onset Date:
Rec V Date: 10/23/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Chills, Dizziness, Injection site pain, Myalgia, Pyrexia

Symptoms: trouble speaking; with the balance which he fell on the flour,; muscle ache; severe headache/Caller reports an extremely strong headaches.; he took some medication to help him sleep at night; Weakness; Equilibrium is way off; Back hurts; below 98.6 degrees, after the first vaccine; Felt extremely horrible; Could not hardly walk; This is a spontaneous report from a contactable consumer or other Non-Health Care Professional. A male patient of an unspecified age received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration on 22Apr2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced trouble speaking, the issue with the balance which he fell on the flour, muscle ache and severe headache which he took some medication to help him sleep at night, Weakness, Equilibrium is way off, Could hardly get out of bed, and fell out of bed and couldn't get up, Could hardly get out of bed, and fell out of bed and couldn't get up, Back hurts, his temperature went up 1.2 degrees and down 1.2 degrees, below 98.6 degrees. Caller is afraid to take the second dose schedule because he might have severe side effects. Second dose schedule will be on 13May2021. At the time of reporting, the outcome of the events were unknown. No follow-up attempts are possible; Information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1812450
Sex: F
Age:
State: HI

Vax Date: 05/07/2021
Onset Date: 05/07/2021
Rec V Date: 10/23/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011L20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site pain, Pain

Symptoms: tingling feeling on body; warmness; Phlegm coming up; cough; Sore throat; Achy Feeling; Low Feverish Feeling; Fatigue; Dry throat; felt she developed a common cold; This is a spontaneous report from a contactable consumer or other non hcp. A 45-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EWB163) via an unspecified route of administration, administered in left arm, on 07May2021 09:30 (at the age of 45 year), as dose 2, single for COVID-19 immunization. The patient medical history was not reported. The patient concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: ERB735) via an unspecified route of administration, administered in left arm, on 16Apr2021 (at the age of 45 year), as dose 1, single for COVID-19 immunization. History of all previous immunization with the Pfizer vaccine considered as suspect was both doses of the Pfizer COVID-19 vaccine. The patient was not received additional vaccine administered on same date of the Pfizer suspect. The adverse event was not resulted in Emergency room and Physician office visit. Prior vaccination within 4 weeks reported was both doses of the Pfizer COVID-19 vaccine. Following prior vaccination, the patient was not experienced adverse event. The patient stated, she received second dose of Pfizer COVID-19 vaccine last Friday morning (07May2021) and 18 hours later she reported warmness of body (on unspecified date), achy body, low grade fever, tingling feeling on body (on an unspecified date), fatigue (on 08May2021), dry throat (on 07May2021), phlegm coming up (10May2021) and then developed sore throat on Sunday (09May2021). On 10May2021, the patient feels like she has to cough. The patient stated, she felt like she developed a common cold, but her symptoms went away very fast which is unusual for her. The patient asked if it helps with the common cold. The patient stated, she called Pfizer because she wanted to know if the vaccine can help to fight against the common cold. The patient stated, she received second dose of vaccine on 07May2021 and at the same time she got the common cold from her child. The patient stated, her symptoms were similar to the second vaccine side effects, but she realized she was fighting a cold. The patient stated, she has already gotten rid of the phlegm and green (as reported) and she feels fine now on day 4. The patient stated, she got the second vaccine at 09:30 on Friday (07May2021), and she started to have some achy feelings and a low feverish feeling when she was sleeping at 03:30 (on 08May2021). As a therapeutic measure, the patient received Theraflu 3 times yesterday (on unspecified date), Gargle with silver structured water a couple of times and swallow, Vitamin C, Zinc, Turmeric capsule. The outcome of tingling feeling on body, common cold, warmness of body was unknown. The outcome of achy feeling, low feverish feeling was recovered on 08May2021. The outcome of fatigue, dry throat was recovered on 09May2021. The outcome of cough, phlegm coming up, sore throat was recovered on 11May2021. No follow-up attempts are needed. No further information is expected

Other Meds:

Current Illness:

ID: 1812451
Sex: F
Age:
State: NY

Vax Date: 05/09/2021
Onset Date: 05/09/2021
Rec V Date: 10/23/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site pain, Menorrhagia

Symptoms: she was not given the Pfizer covid vaccine into the deltoid muscle; her arm is red; her arm is swollen; This is a spontaneous report from a contactable consumer (patient herself). A 40-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EW0123; Expiration date: unknown) via an unspecified route of administration, administered in Arm Right on 09May2021 as DOSE 2, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient's Medical History (including any illness at time of vaccination) was reported as no. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) was reported as none. AE(s) following prior vaccinations was reported as no. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient had previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EW0162; Expiration date: unknown) via an unspecified route of administration, administered in Arm Right on 18Apr2021 as DOSE 1, SINGLE for COVID-19 immunization. On 09May2021 it was reported that, the caller explained she got the dose on Sunday and it was not given in the correct site; it was not given the upper deltoid area. She explained that it was given more in the middle of the arm between the elbow and the shoulder, not the bicep but the front of that like the medial triceps area. The location the vaccine was being administered was a mega center but there were military people administering the product. Now her arm was red and swollen and she was concerned she did not get the full dose and will not have full immunity. She had questions about this. The area that was red and swollen was noticed a few hours after getting the shot. There was a half dollar swollen area that was like a welt and was raised and a red area at the inject site. It was not painful. AE(s) did not require a visit to emergency room or physician office. Patient had not relevant tests. The outcome of event her arm is red and her arm is swollen was not resolved. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1812452
Sex: M
Age:
State:

Vax Date: 04/28/2021
Onset Date: 05/10/2021
Rec V Date: 10/23/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025J20A
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Arthralgia, Chills, Headache, Mobility decreased, Myalgia

Symptoms: reddish type of rash on the back and front of his body, the upper arms and a little on his neck/rash all on the front and sides of his body; This is a spontaneous report from a contactable consumer or other non hcp (patient himself). A 74-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot Number: EW0183, Expiry date: Unknown) via an unspecified route of administration on 28Apr2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 10May2021 the patient experienced yesterday, he developed a reddish type of rash on the back and front of his body, the upper arms and a little on his neck/rash all on the front and sides of his body. The outcome of events was unknown. Information about batch/Lot number has been requested.

Other Meds:

Current Illness:

ID: 1812453
Sex: F
Age:
State: MI

Vax Date: 04/14/2021
Onset Date: 04/01/2021
Rec V Date: 10/23/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Nausea, Pain in extremity, Pyrexia

Symptoms: itchy eyes started from eyebrows; doesn't feel good; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 69-year-old female patient reported for herself that she received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: Unknown, Expiration date: Unknown), via an unspecified route of administration on 14Apr2021 as DOSE 2, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took bnt162b2 (Batch/Lot number was not reported), via an unspecified route of administration on 24Mar2021 as DOSE 1, SINGLE for covid-19 immunization. On an unspecified date in Apr2021, after a week, the patient developed itchy eyes that started from eyebrows. The patient had sought consultation to ophthalmologist on 28Apr2021 or 29Apr2021 and was advised that it might be an allergic reaction to something. As the days went by it became worst. She wants to know if itchiness of her eyes is an allergic reaction from the COVID 19 vaccine that she had. she doesn't feel good and just wants to know if it's a reaction to the vaccine or not. The patient was seen by her primary care doctor and was prescribed cream (unspecified) for itchiness. Therapeutic measures were taken as a result of the itchy eyes started from eyebrows. Outcome of the event was not recovered. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1812454
Sex: M
Age:
State: NC

Vax Date: 05/08/2021
Onset Date: 05/08/2021
Rec V Date: 10/23/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: UNK
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: high temperature (38C and more)/ fever symptoms; headache; strong fatigue; inflamed lymph nodes in the armpits; This is a spontaneous report from a contactable consumer (patient). A 36-years-old male patient received BNT162B2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection, Batch/Lot Number: EW0182), via an unspecified route of route of administration, administered at left arm on 08May2021 at 10:00 A.M (at the age of 36-year-old) as dose 2, single for covid-19 immunisation. Medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection, Batch/Lot number: EW0189) via an unspecified route of administration, administrated at left arm on 17Apr2021 at 10:00 A.M (at the age of 36-year-old) as dose 1, single for covid-19 immunization. The patient does not receive any other vaccines within 4 weeks prior to the COVID vaccine. No known allergies reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included meloxicam and tamsulosin hydrochloride (TAMSLUSIN); both from an unspecified date for an unspecified indication. On 08May2021 at 17:00, the patient had a high temperature (38C and more) and had it for two days/ fever symptoms, headache, a strong fatigue for two more days already and it did not pass yet and inflamed lymph nodes in the armpits. The patient did not receive any treatment for the events. Outcome of the events was not recovered. No follow-up attempts are needed. No further information is expected.

Other Meds: MELOXICAM; TAMSLUSIN

Current Illness:

ID: 1812455
Sex: M
Age:
State: NY

Vax Date: 04/04/2021
Onset Date: 04/05/2021
Rec V Date: 10/23/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Headache, Heart rate increased, Injection site erythema, Injection site pain, Injection site swelling

Symptoms: phlegm that was green in the morning; heaviness in his chest; with first dose he had just the sore arm; This is a spontaneous report from a contactable consumer or other non-health professional (patient). This 42-year-old male patient received bnt162B2 (BNT162B2, solution for injection, Batch/Lot number: EP7533) via an unspecified route of administration, in Left arm on, 04Apr2021 at 13:00, as DOSE 1, single for COVID-19 immunisation (age at vaccination:42-years-old).The patient's medical history and concomitant medications was not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient laboratory test were not reported. The clinical course was as follows: Patient reported that his experience was unusual with the Pfizer vaccine. With the first dose he just had sore arm. It occurred that day or night and lasted 24 hours, probably not that long. He got his 1st shot exactly 6 weeks ago. Added, exactly 5 weeks, rather. 10 days later he began feeling heaviness in his chest. He had no cough but had phlegm that was green in the morning. He had no cough, no fever, chills or loss of taste. He felt fine, until the second shot. The heaviness in the chest he had since 15Apr2021 and has kind of decreased. He was not short of breath, had no cough, just green phlegm. He never experienced phlegm without a cough or congestion, but it went away before the 2nd shot. The event sore arm recovered on 06Apr2021.The outcome of the event phlegm that was green in the morning was recovered on an unspecified date before the second shot on 25Apr2021. The outcome of the event heaviness in his chest was resolving. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1812456
Sex: F
Age:
State: SC

Vax Date: 04/19/2021
Onset Date: 04/19/2021
Rec V Date: 10/23/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Nausea

Symptoms: Menstruation abnormally long after 1st dose of vaccination.; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 47-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIOTECH COVID-19 VACCINE, solution for injection, Lot number was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 19Apr2021 at 15:00 (age at vaccination: 47 years) as dose 1 single for covid-19 immunisation. Patient's medical history included hypothyroidism.Patient did not receive any other vaccine in 4 weeks. Concomitant medication included varenicline tartrate (CHANTIX) taken for an unspecified indication, levothyroxine sodium (SYNTHROID) taken for an unspecified indication, ethinylestradiol, norgestimate (TRI LO MILI) taken for an unspecified indication. No known allergies were reported. Patient did not have Covid prior to vaccination. Patient was not tested COVID post vaccination. On 19Apr2021 at 03:00 pm, the patient experienced menstruation abnormally long after 1st dose of vaccination. Therapeutic measures change in birth control were taken as a result of menstruation abnormally long after 1st dose of vaccination. At the time of this report, the outcome of event was recovered on an unknown date in 2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds: CHANTIX; SYNTHROID; TRI LO MILI

Current Illness:

ID: 1812457
Sex: F
Age:
State: IL

Vax Date: 03/22/2021
Onset Date: 04/26/2021
Rec V Date: 10/23/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: UNK
Vax Route: IM
Vax Site: LA

Lab Data: Test Date: 20210426; Test Name: blood test; Result Unstructured Data: Test Result:UNKNOWN; Test Date: 20210426; Test Name: Chest X-ray; Result Unstructured Data: Test Result:UNKNOWN

Allergies:

Symptom List: Injection site pain

Symptoms: sick; started having asthma at that time; This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient) via Pfizer sponsored program. A 52-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: solution for injection, Batch/Lot Number: EP6955; Expiration Date: Jun2021), via an unspecified route of administration, administered in Arm Left on 22Mar2021 11:45 (at age of 52-years-old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included asthma and ongoing chronic obstructive pulmonary disease. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Adverse events following prior vaccinations was reported as none. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available)was reported as none. No additional administered vaccines if applicable, list all vaccines administered on same date with the Pfizer vaccine considered as suspect was reported. Concomitant medication(s) included salbutamol (Ventoline [Salbutamol] taken for an unspecified indication from an unspecified start date and ongoing and Brio inhaler (Formulation, Batch/Lot Number and Expiration Date: not reported) only as needed. Clarified spelling of Brio inhaler, documented as provided. The patient experienced sick on an unspecified date and on 26Apr2021 03:00 patient experienced asthma. The patient was scheduled for second dose on 26Apr2021 and has missed her second dose as she was sick. The patient reported that she was in the hospital. She has a history of asthma and chronic obstructive pulmonary disease and she had to go to the hospital for a treatment. Clarified caller went to the emergency room and the caller confirmed she was not admitted to the hospital. The caller needs to know where she can go for her second dose Covid 19 vaccine. She's not sure if the facility where she received her first dose are still doing vaccines at that site. She reports she called the paramedics to take her to the hospital around 3:00AM on 26Apr2021. She started having asthma at that time and she received a treatment in the emergency room and within 45 minutes she was feeling better. She was discharged from the emergency department around 7:00AM-8:00AM on 26Apr2021. The patient underwent lab tests and procedures on 26Apr2021 which included blood test and chest x-ray, the results were unknown. Therapeutic measures were taken as a result of started having asthma at that time (asthma). The outcome of the event sick was unknown and the outcome of the event asthma was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds: VENTOLINE [SALBUTAMOL]

Current Illness: Chronic obstructive pulmonary disease (Verbatim: Chronic obstructive pulmonary disease)

ID: 1812458
Sex: U
Age:
State:

Vax Date: 04/14/2021
Onset Date:
Rec V Date: 10/23/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site induration, Injection site pruritus, Injection site swelling, Injection site warmth

Symptoms: I had severe headache in back of my head; This is a spontaneous report from a contactable consumer or other non hcp (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: UNKNOWN), via an unspecified route of administration on 14Apr2021 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: UNKNOWN), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. It was reported that three weeks ago on 14Apr2021 patient took the vaccine and then patient had severe headache in back of head, very severe headache, it goes and it comes right away on an unspecified date. Patient stated that had been taking Tylenol but it does not really work so patient started taking Aspirin. Patient don't want to report it, patient want to know what should do, is this normal, this is the headache. The patient received treatment as a result event. Outcome of the event was not resolved. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1812459
Sex: M
Age:
State: MD

Vax Date: 04/30/2021
Onset Date:
Rec V Date: 10/23/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011j20a
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Chills, Dizziness, Nausea, Pain, Tachycardia

Symptoms: shoulder and chest pain; shoulder and chest pain; pressure across his chest; This is a spontaneous report from a contactable consumer (patient). A 56-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on 30Apr2021 at 16:20 (age at vaccination: 56 years), as dose 2, single dose for COVID-19 immunization. The patient's medical history included heart attack in Dec2017. Past drug included Imdur (60mg once per day by mouth), lisinopril (10mg once per day by mouth), Atorvastatin (40mg once per day by mouth), and Carvedilol (6.25mg and takes two per day of one in the morning and one in the evening). Concomitant medications included lisinopril, isosorbide mononitrate (IMDUR), atorvastatin calcium (ATORVASTATIN AL) and carvedilol. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an un-specified route of administration, on 07Apr2021, as dose 1, single dose for COVID-19 immunization. The patient did not received any vaccine prior vaccinations (within 4 weeks). The patient experienced shoulder and chest pain 4-5 days after his second shot on an unspecified date. He just had the vaccine 2nd dose on 30Apr2021 and was telling his cardiologist how he was feeling and told him with activity and pushing his heart on the treadmill he did not feel any-thing but then he started putting the pieces together. He began having pressure across his chest and looked it up on the CDC and it said during the trials there were three heart attack type things reported and he wanted to find out if Pfizer had narrowed down that information to a particular medication or it happened almost right away after the vaccine or if it was a few weeks later; states he did not have the reported events prior to the Pfizer COVID vaccine and has worked very hard and lost 80 pounds and changed his diet and the pressure in his chest started about 4 days after the 2nd dose of the Pfizer COVID Vaccine. The patient stated he has not yet required treatment for the reported events. The adverse events did not require a visit to emergency room. There was a Product Complaint. Outcome of the events shoulder and chest pain was unknown and pressure across his chest was not recovered. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds: LISINOPRIL; IMDUR; ATORVASTATIN AL; CARVEDILOL

Current Illness:

ID: 1812460
Sex: F
Age:
State: TX

Vax Date: 05/05/2021
Onset Date:
Rec V Date: 10/23/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 039K20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Tremor

Symptoms: head spinning; caller experienced pain over her body, throbbing pain; intermittent warm feeling over her body; dizzy; tired; muscles ache; Her shoulder started hurting first,The her wrist started hurting; then it moved to under her arm; so bad she did not sleep at all; Caller reports suddenly she would break out in sweats; This is a spontaneous report from a contactable consumer (patient). A 54-years-old female patient received second dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection, Batch/Lot number EW0172) via intramuscular, administered in Arm Left on 05May2021 13:00 (age at vaccination 54 years) as dose 2, single for covid-19 immunisation. The patient's Medical history included she started gaining some weight. This started before she got the Pfizer COVID Vaccine. she reports no one else in her family would get the shot her brother, her sister, no one else would get it. Hepatitis-Onset Date: She got it when she was 17; Stop Date: she does not know if she still has it or not. Arthritis-onset Date: Diagnosed along time ago. Degenerative Joint disease; Onset Date: Diagnosed along time ago. patient was a waitress but, has not worked since but, because one of her co-workers got COVID and died. patient was not sure if this stuff could be from the Hepatitis, she was not sure. The concomitant medications not reported. The patient previously received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection, Batch/Lot number ER8733), dose 1 intramuscular, administered in Arm Left on 14Apr2021 13:00 (age at vaccination 54 years) as dose 1, single for covid-19 immunisation. After the first shot she had a bruise on her arm for week after she got it. It lasted about a week. Vaccination Facility Type was at Park, its a big hub where they gave it. There was no history of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available). There was no additional Vaccines Administered on Same Date of the Pfizer Suspect. AE did not require a visit to emergency Room. There was no prior Vaccinations (within 4 weeks). On an unknown date, patient reports ever since she had the 2nd shot her head has been spinning, she was dizzy, tired, everything hurts. Her muscles ache, when she moves something hurts. Her shoulder started hurting first, then it moved to under her arm, that was some of the worst pain she has had in her life. her wrist started hurting, so bad she did not sleep at all. Then her other shoulder hurt she thinks something was wrong and wants to know when her symptoms will go away. It has been 7 days since her 2nd shot. she reports suddenly she would break out in sweats, her body just starts heating up and she starts sweating. patient reports something was going on. After the 1st shot head was spinning, it was so bad she shut her eyes in her room but, the room just kept spinning. She was so dizzy. she reports she was dizzy and a little tired after getting the 1st shot, but after the 2nd shot she just doesn't sleep after getting it. After she got the shot she has been hurting ever since after the 1st night, the pain in her shoulder started, then it went under her arm, a throbbing pain. Then, it shot down to her calf, its weird. Her muscles just ache. She put a wrap on her wrist because she had no strength in her wrist, she wore a wrist band and the next day it was fine. Head spinning, dizzy, tired : patient reports it comes and goes, last night it spun. On the 1st or 2nd night after the 1st shot, she would try to lay down and the room was just spinning. She was just dizzy and tired, after the 1st shot it was like that but, after the second it was more stuff. Not Sleeping: It has been ongoing, last night she could not sleep, her other shoulder hurt and so slept on the couch. Sweating: Last night it started, she thought she had a hot flash but, she doesn't think it was a hot flash, its weird. She felt it get hotter and hotter and hotter. It comes and goes. she reports last night it was cold because it rained last night. she reports she was in near her state. She reports the feeling just comes over you like a river, she was burning up and like started sweating. It comes and goes. Pain in the shoulders, under her arm, her wrist and her calf; muscle aches: They hurt all last night, all night like her wrist. She put the cream on and she went to sleep then the pain in her wrist was gone. Like on Sunday, it hurt for hours on Sunday, her wrist. she reports something else hurts every day, its going through all her body, it feels like the pain was hitting every muscle, its weird. patient reports she was diagnosed with Arthritis and degenerative joint disease. She was diagnosed along time ago, it started before, about 3 years ago in her back. She kept going to the hospital due to such back pain. she reports she doesn't normally hurt. Like one time when she had her daughter, when she was 42. patient reports she did not sleep last night. she reports she needs her glasses to read the vaccine card. Treatment included she reports even the arthritis they gave her along time ago, she has been. They told her her next step would be pain management, so she never went back to the doctor even back then. They gave her Naproxen but, she never took it, well maybe one every once in a while, but, she has not taken it and has not been taking it. Naproxen: NDC, Lot and Expiration: She still has them but, she was not taking them. They are in her medicine cabinet. patient reports she has not been to a doctor in over 2 years. She does not know what was going on with all this dizziness and this pain. Ointment: Capsaicin Deep Penetrating, Odour Free, Arthritis Pain Relief. NDC, Lot, Expiration Date: patient reports she needs to get her glasses to read it. Expiration: Confirmed with the patient that it was NOV 2021. she used an ointment for the muscle aches. The outcome of events was reported as unknown. No follow-up attempts are needed. No further information was expected.

Other Meds:

Current Illness:

ID: 1812461
Sex: F
Age:
State: CT

Vax Date: 04/13/2021
Onset Date: 04/13/2021
Rec V Date: 10/23/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Erythema, Pruritus

Symptoms: Hives; itching/itching on injection site; Redness,Lump, itching on injection site a few days after vaccination; Redness,Lump, itching on injection site a few days after vaccination; This is a spontaneous report from a contactable consumer. This 64-year-old female consumer (patient) reported that: A 64-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0153), via an unspecified route of administration in Arm Left on 13Apr2021 at 12:30 PM (age at the time of vaccination was 64 years) as DOSE 2, SINGLE for covid-19 immunisation. Patient known allergies: fluconazole. The patient medical history includes high blood pressure, osteoporosis, arthritis, herniated disc. Concomitant medication was not reported. The patient receive other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. Patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: 8727), via an unspecified route of administration in Arm Left on 23Mar2021 at 14:00 (at the age of 64-year-old) as DOSE 1, SINGLE for covid-19 immunisation and experienced hives and itching half hour after vaccine. On 13Apr2021 13:00 patient experienced hives, itching/itching on injection site. On unspecified date in 2021 had redness and lump on injection site a few days after vaccination. Patient didn't received treatment for the events. The clinical outcome of the events was not recovered. No follow-up attempts are required. No further information is expected.

Other Meds:

Current Illness:

ID: 1812462
Sex: F
Age:
State:

Vax Date: 05/10/2021
Onset Date:
Rec V Date: 10/23/2021
Hospital:

Vax Type: UNK
Manufacturer: UNKNOWN MANUFACTURER
Vax Name: VACCINE NOT SPECIFIED (NO BRAND NAME)
Lot:
Dose Series: UNK
Vax Route: SYR
Vax Site: UN

Lab Data:

Allergies:

Symptom List: Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling, Myalgia

Symptoms: sharp pain in the middle of her chest; feeling fatigue; sore throat; achiness in her arm and back; This is a spontaneous report from a contactable consumer reported for daughter (patient) that: A 27-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 10May2021 as DOSE 2, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Previously patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 19Apr2021as DOSE 1, SINGLE for COVID-19 immunization.On an unspecified date the patient experienced sharp pain in the middle of her chest, feeling fatigue, sore throat and achiness in her arm and back. It was reported that Patient received her second dose of the Pfizer-BioNTech COVID-19 vaccine yesterday and experienced a sharp pain in the middle of her chest about 10 minutes ago. She asked her daughter to join the line and her daughter added she has been feeling fatigue, a sore throat, achiness in her arm and back. Her daughter also described the pain on her chest as shooting pain at first which lasted between 10-15 minutes and now it feels more like a tightness with sharp pain here and there. They asked if chest pain were reported as side effect from the vaccine. The outcome of the events was unknown. No follow-up attempts are needed. information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1812463
Sex: F
Age:
State: NC

Vax Date: 04/01/2020
Onset Date:
Rec V Date: 10/23/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Cough, Limb discomfort, Pain, SARS-CoV-2 test positive

Symptoms: Body aches; A low grade fever; And exhaustion,following her covid vaccination, she states the symptoms only lasted a day; This is a spontaneous report from a contactable consumer (herself) via Pfizer sponsored program Accredo Xeljanz. A 61-years-old non pregnant female patient received bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation; Tofacitinib citrate (XELJANZ), oral from Apr2020 (Batch/Lot number was not reported) to an unspecified date, at 5 mg, 2x/day for psoriatic arthropathy. No known allergies and medical history was reported. Concomitant medications included olmesartan medoxomil; rosuvastatin calcium (CRESTOR); omeprazole; vitamin d [vitamin d nos]; tramadol hcl and meloxicam (MOBIC) taken for an unspecified indication, start and stop date were not reported. The patient was not pregnant at time of vaccination. The patient experienced in 2021 body aches, a low grade fever, and exhaustion, following her covid vaccination, she stated the symptoms only lasted a day on Feb/Mar 2021. No treatment measures were taken as result of events. The clinical outcome of the events were recovered in 2021. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds: OLMESARTAN MEDOXOMIL; CRESTOR; OMEPRAZOLE; VITAMIN D [VITAMIN D NOS]; TRAMADOL HCL; MOBIC

Current Illness:

ID: 1812464
Sex: F
Age:
State: AZ

Vax Date: 05/07/2021
Onset Date: 05/01/2021
Rec V Date: 10/23/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 039K20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Asthenia, Chills, Headache, Myalgia

Symptoms: eyes were a little bit swollen; it is a little itchy; congestion; being sneezing a lot; This is a spontaneous report from a contactable consumer (Patient). A 35-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EWO1TO), via an unspecified route of administration on 07May2021 (at the age of 35 years old) as a single dose for COVID-19 immunisation. The patient's medical history included Seasonal allergy, Prediabetes from an unknown date and unknown if ongoing. The patient's concomitant medication included Prempro (ESTROGENS CONJUGATED, MEDROXYPROGESTERONE ACETATE) taken for hormones and start date and stop date was not reported. On an unspecified date of May-2021 the patient experienced eyes were a little bit swollen, Itchy, congestion, being sneezing a lot. The patient reported that her eye got too it was like its swollen but in two different parts like lid and then patient's upper eye lid and in the eye lid area and like patient was telling (name), patient did not know she got the vaccine on 07May it was a friday. So on Monday night patient noticed two swollen spots on eye. The patient was napping so she was not sure when that happened. Patient was washing face when Patient noticed swelling of the eye. The patient had tend to have seasonal allergy, it was just during spring and during fall time. So like the patient was telling (name) yesterday patient had Tylenol for my allergy but patient was calling to make sure she could take Zyrtec because this is something new the vaccine. The patient did not know if the patient could take over the counter medication so that's why patient called this number in the web page. The patient did not receive any treatment for events. The outcome of the events was unknown. Follow-up(11May2021): This is a follow-up spontaneous report from a contactable consumer included Relevant medical history was added, Patient information updated, Product details were added and Concomitant drugs were added. Follow-up attempts are completed. No further information is expected.

Other Meds: Prempro

Current Illness:

ID: 1812465
Sex: M
Age:
State: CA

Vax Date: 03/24/2021
Onset Date:
Rec V Date: 10/23/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011J20A
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data: Test Name: ABIGG; Result Unstructured Data: Test Result:The first was an ABIGG, SPIKE S and the reading wa; Comments: the reading was a little arrow to the left less than 1; Test Name: Blood work; Result Unstructured Data: Test Result:Good; Comments: controlled by Imbruvica.; Test Name: Corona IGG; Test Result: Negative ; Comments: He had the immunity test to check if he gained immunity to the shots, like Corona IGG /Sars Covid 2 IGG spikes both came out negative.; Test Name: lymphocytes; Result Unstructured Data: Test Result:50-60% lymphocytes; Test Name: Sars Covid 2 IGG spikes; Test Result: Negative ; Comments: He had the immunity test to check if he gained immunity to the shots, like Corona IGG /Sars Covid 2 IGG spikes both came out negative. the little arrow read to the left of 1.4. and then later were 0.04 and 0.02 readings.; Test Name: SPIKE S; Result Unstructured Data: Test Result:The first was an ABIGG, SPIKE S and the reading wa; Comments: the reading was a little arrow to the left less than 1; Test Name: WBC count; Result Unstructured Data: Test Result:16K

Allergies:

Symptom List: Injection site erythema, Injection site pain, Injection site swelling

Symptoms: Sore arm; Little lightheaded; Tired; Got the Pfizer vaccines 1st dose-03/04/2021 and 2nd dose 03/24/2021 (less than 21 days in between doses).; Got the Pfizer vaccines 1st dose-03/04/2021 and 2nd dose 03/24/2021 (less than 21 days in between doses).; This is a spontaneous report received from a contactable consumer or other non-healthcare professional (Patient). A 76-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration on 24Mar2021 as dose 2, single for COVID-19 immunisation. The patient medical history included chronic lymphocytic leukaemia (he was diagnosed 14-15 months ago with CLL, He had a spleen that was measuring 22cm and was pushing his stomach out. He has moved from Stage 2 to Stage 0), dental disorder nos, orthopaedic, heart issues from an unknown date and unknown if ongoing. The concomitant medications included ibrutinib (IMBRUVICA) taken for an unspecified indication, start and stop date were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration on 04Mar2021 (at the age of 76-years-old) as dose 1, single for covid-19 immunisation. On unspecified date, the patient experienced sore arm, little lightheaded, tired and got the pfizer vaccines 1st dose-03/04/2021 and 2nd dose 03/24/2021 (less than 21 days in between doses). The patient asked that hopefully after the two initial doses and the booster I'm hoping to have some immunity. The patient also asked about data on patients with CLL or leukemia. He was confused, if there is a way to test for efficacy after the vaccine or not. On an unspecified date, the patient underwent lab tests and procedures which included blood immunoglobulin g: the first was an abigg, spike s (was a little arrow to the left less than 1), blood test: good (controlled by Imbruvica), investigation resulted negative (He had the immunity test to check if he gained immunity to the shots, like Corona IGG /Sars Covid 2 IGG spikes both came out negative), lymphocyte count resulted 50-60% lymphocytes, sars-cov-2 antibody test resulted negative (He had the immunity test to check if he gained immunity to the shots, like Corona IGG /Sars Covid 2 IGG spikes both came out negative and the little arrow read to the left of 1.4. and then later were 0.04 and 0.02 readings), sars-cov-2 antibody test: the first was an abigg, spike s (the reading was a little arrow to the left less than 1) and white blood cell count resulted 16k. The outcome of the events was reported as unknown. No follow-up attempts are needed, information about lot/batch number cannot be obtained.

Other Meds: IMBRUVICA

Current Illness:

ID: 1812466
Sex: M
Age:
State: NY

Vax Date: 05/08/2021
Onset Date: 05/10/2021
Rec V Date: 10/23/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot: EK9231
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Chills, Feeling cold, Feeling hot, Myalgia, Pain

Symptoms: he developed a rash from his chest to his arms and legs, and now it is on all of his face; he started to develop a rash and had a telehealth appointment with a doctor and they said it looked like chicken pox; and the doctor said in their opinion that the rash looks like Chicken Pox; This is a spontaneous report from a contactable pharmacist. A 21-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, lot number and Expiry date: not reported) (age at the time of vaccination was 21 years), via unspecified route on 08May2021 as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medication was not reported. Patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, lot number and Expiry date: not reported), via unspecified route on an unspecified date, as dose 1, single for COVID-19 immunization. On 10May2021, the patient had developed rash from his chest to his arms and legs, had a telehealth appointment with a doctor and they said it looked like chicken pox. The outcome of the event was unknown. No follow-up attempts were possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1812467
Sex: F
Age:
State:

Vax Date: 09/11/2020
Onset Date:
Rec V Date: 10/23/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Pain in extremity

Symptoms: Muscle soreness; This is a spontaneous report based on the information received by facilitating company. (MCN#: 2021US000559) from a non-contactable consumer (Patient). A 58-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: not reported, Expiry date: not reported), via an unspecified route of administration on an unspecified date (at age of 58-years-old) as dose number unknown, single for covid-19 immunization. Co-suspect included abaloparatide (TYMLOS, Formulation: injection, Batch/Lot number: not reported, Expiry date: not reported), 80 mcg once day subcutaneously on 11Sep2020 for age-related osteoporosis without current pathological fracture. The patient medical history and concomitant medication was not provided. Relevant surgical, social, or substance-usage history was not provided. On an unspecified date, the patient experienced had muscle soreness after she received the bnt162b2 vaccine. On unknown date, the patient had increased muscle- soreness. No relevant lab or diagnostic tests were reported. The action taken in response to the event for abaloparatide was dose not changed. No treatment was reported. The outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1812468
Sex: U
Age:
State: PA

Vax Date: 04/14/2021
Onset Date: 04/01/2021
Rec V Date: 10/23/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot:
Dose Series: 2
Vax Route:
Vax Site:

Lab Data: Test Name: Antinuclear antibody; Result Unstructured Data: Test Result:Normal; Test Name: Polymerase chain reaction flu; Result Unstructured Data: Test Result:Normal; Test Name: SARS-CoV-2 test; Result Unstructured Data: Test Result:Normal; Test Name: Body temperature; Result Unstructured Data: Test Result:daily elevated

Allergies:

Symptom List: Abdominal pain upper, Abnormal behaviour, Adverse reaction, Anger, Asthma

Symptoms: These symptoms included fever, fatigue, malaise, and joint pain/Has had over a month of fever; These symptoms included fever, fatigue, malaise, and joint pain; These symptoms included fever, fatigue, malaise, and joint pain; These symptoms included fever, fatigue, malaise, and joint pain; This is a spontaneous report from a contactable physician reported for patient. This is 1 of 2 reports. A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date: not reported), via an unspecified route of administration, administered at unspecified anatomical location on 14Apr2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced fever/has had over a month of fever in Apr2021, these symptoms included fever, fatigue, malaise, and joint pain in 2021. The patient underwent lab tests and procedures which included antinuclear antibody: normal, polymerase chain reaction: normal, sars-cov-2 test normal. The reporter asked regarding two of his patients and seek any medical information to help him better make his decisions in providing treatment. HCP states that his first patient received the Pfizer COVID 19 vaccine on 14APR2021 and developed adverse effects beginning the following day and states that this has been ongoing with symptoms for a month and that he has seen the patient around 4 times since then which the last visit being 10MAY2021. The patient continues to have daily elevated temperatures throughout the day, but the other symptoms have started to decrease. Reporter have run tests to rule out other things such as ANA, PCR flu, covid, body temperature: daily elevated etc. and they have all resulted normal. The reporter asked are there been reports of ongoing fevers like this. The reporter wants to know is there any information on the efficacy of the Pfizer COVID 19 vaccine when the doses are given longer than 21 days apart. The reporter reported that he wanted to see if Pfizer has any information regarding patients running fevers for an extended period following the Covid-19 vaccine and declined to complete safety report. Report filed with minimal information provided. Reporter provided with phone number, and reportum reference number, JPVY58TK, prior to transfer. The outcome of the event was unknown No follow-up attempts are needed. Information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1812469
Sex: M
Age:
State: MI

Vax Date: 04/27/2021
Onset Date: 04/29/2021
Rec V Date: 10/23/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 039K20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Consciousness fluctuating, Crying, Dry skin, Epistaxis, Headache

Symptoms: feels tiredness; back ache; Rash and Itches, broke out, wrist going away; This is a spontaneous report from a contactable consumer (patient). A 67-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number was ER8733 and expiration date was not reported), via an unspecified route of administration, administered in left arm on 27Apr2021 at 10:30 (Age at vaccination was 67 years) as dose 2, single for covid-19 immunisation. Medical history included ongoing seasonal allergy (patient states had sneezing but that is going away), herpes zoster from an unknown date and unknown if ongoing (he has had the shingles shot before, and he was supposed to be due for the second one, but they said to wait a month after the last Covid vaccine. Patient states his first shot from the shingles vaccine, he noticed that it wore him out too because they gave him the virus and he was tired for a few days). The patient's concomitant medications were not reported. Previously patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: EW0150 and expiration date were not reported), via an unspecified route of administration, on 01Apr2021 as dose 1, single for COVID-19 immunization. The patient experienced rash and itches, broke out, wrist going away on 29Apr2021. Patient noticed that he developed some rash in right hand, left wrist and behind his knee in right leg about 3-4. On 30Apr2021, the patient experienced feels tiredness, back ache. He says about the tiredness that he could be in bed all day and he does not feel like doing some morning exercise and about the back pain, he feels like a back spasm that has given him problems in his golf (he missed yesterday course) and washing his car. Patient also states he doesn't remember injuring his back. Patient states it was severe last night, but it comes and goes. States when he was sitting still it goes away but it was still there when he bends over to the left and right, he had muscle soreness. States he was lethargic and could sit in the chair all day and not move. Patient states he was hoping it didn't effect his kidneys, it was on the lower right side. The patient did not perform any relevant test. Patient had Laser treatment on his back because he thought it was a muscle, but they don't seem to be doing much and Aleve was also took. Therapeutic measures were taken as a result of back ache (back pain). The outcome of all the events was not recovered. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness: Seasonal allergy

ID: 1812470
Sex: F
Age:
State: NV

Vax Date: 05/11/2021
Onset Date: 05/01/2021
Rec V Date: 10/23/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Hypotonia, Lethargy, Respiratory rate decreased, Screaming, Skin warm

Symptoms: cough; She is hot and cold; She woke up last night 3 hours later sore in her arm, and a little sicky sicky; nausea; chills; joint and muscle pain; headache; very tired; joint and muscle pain; little sicky sicky; Feeling weak; shivering; All the side effects have worsened; feels like she is going to pass out; This is spontaneous report from a contactable consumer (patient). A 69-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0L68), dose 1 via an unspecified route of administration, administered in Arm Right on 11May2021 13:00 as (Age at Vaccination 69-years-old) DOSE 1, SINGLE for COVID-19 immunization. Medical history included stent placement from Feb2021 to Feb2021, I have trouble passing bowel and urine from an unknown date and unknown if ongoing, Bladder bag from an unknown date and unknown if ongoing.Concomitant medications were not reported. On 12May2021 the patient experienced nausea, chills, joint and muscle pain, headache, very tired. on an unspecified date the patient experienced cough, she is hot and cold, she woke up last night 3 hours later sore in her arm, and a little sicky sicky. On 11May2021 joint and muscle pain (Arthralgia), On May2021 patient experienced little sicky sicky , feeling weak, shivering, all the side effects have worsened, feels like she is going to pass out. It was reported that As per caller she received her 1st dose yesterday (11May2021), since then she had, nausea, chills (hot and cold), shaking, joint and muscle pain, headache and very tired, and had a cough this morning. Caller added, I have trouble passing bowel and urine, around the holidays last year I had a severe blockage and in Feb2021 I got a stent put. I had been on liquids, I was 5ft5in and 99lbs, can't gain weight and I was still weak from the surgery. I know of 2 girlfriends who were down for 2 days after getting the vaccine. Usually when I get the flu shot, I was down for 3 days. Caller got her first COVID shot yesterday. She has not been feeling well for several months now. She had a blockage in her small intestine and stomach, and they put stents in, in Feb 2021. She only weighs 99 lbs, she was 69 years old. She usually doesn't get the flu shot because she gets sick every time. Caller doesn't have the NDC/lot/expiration for the Flu shots. She didn't take it last year. She went to (withheld) to get her COVID vaccine yesterday. She woke up feeling sick, nauseated, chills, joint pain, muscle pain, and headache. She is tired. She feels like she is going to pass out. She doesn't want to go to the hospital. She had surgery in Feb2021, and they put metal stents in her stomach and intestines. Caller doesn't have a prescribing doctor. She got the vaccine yesterday at 1 o'clock. Today she is weak and shivering. She is hot and cold. She has real joint and muscle pain. All the side effects have worsened. She woke up last night 3 hours later sore in her arm, and a little sicky sicky. The outcome of the events Nausea, chills, joint and muscle pain, headache, very tired was not recovered. While for others was unknown. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1812471
Sex: F
Age:
State: FL

Vax Date: 05/05/2021
Onset Date: 05/01/2021
Rec V Date: 10/23/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 026LZOA
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Vomiting

Symptoms: Hives on left arm and both upper legs; she felt dizzy two days after first dose; itchiness; hot feeling; bump on arm injection site; bump on arm injection site and on upper leg; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 34-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0179, Expiry date: unknown), via intramuscularly in left arm on 05May2021 17:45 (at the age of 34 years old) as dose 1, single for covid-19 immunization. Patients medical history included she was diagnosed with allergies, compromised immune status, respiratory illness, genetic /chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity: Fibroids and ovarian cyst all diagnosed Jan 2021, patients family medical history included, her mother was in remission from breast cancer. Patients concomitant medication included Megestrol Acetate taken orally at 20 mg once a day for micro fibrosis and ovarian cyst, she also said that she was menstruating at the time when she received the vaccine. She received her first dose of Pfizer-Biontech Covid19 vaccine 05May2021. She experienced a delayed reaction, which included hives on her injection arm and bilateral upper legs on 07May2021, itchiness, and a hot feeling that wasn't a fever and she was scheduled to receive her second dose on 26May2021. She experienced side effects include bump on arm injection site and on upper leg on an unknown date in May2021. It was gone now. Also, she felt dizzy two days after first dose. She felt real hot but did not had a fever. It looked like hives on left arm. To her it looked like them. It was small bumps that were slightly raised. It was not that noticeable. She just felt when she rubbed her hand over it. It was also on both upper legs. Patient also stated she did not have dizziness. She was hot the day of and the day after from 05May2021 to 06May2021. The following day was when she had the itchiness from to 06May2021 to 07May2021. She had not taken anything that day but had older medication in her system, which she did report when she went to get shot. It was the Megestrol Acetate. She was also scheduled for a surgery during the first week of June to remove cysts and fibroids, she would have to be put under. She is not sure what other medication they are using. She wants to make sure that that medication will not affect anything or that the vaccine will not affect anything. She experienced adverse events after her first dose and was nervous about the second dose being so close to her surgery. She queried about whether she can still have her surgery as scheduled, She has an operation coming up first week of Jun 2021, to get cyst and fibroids removed. She would have to be put under. She was not sure what other medication they are using. She wants to make sure that that medication will not affect anything or that the vaccine will not affect anything. Second dose was scheduled for 26May2021. She had a pre-op for surgery the day before. There were no additional vaccines administered on same date of the Pfizer suspect, there were no prior vaccinations (within 4 weeks) and no adverse events following prior vaccinations. Outcome of events felt hot and itchy was recovered and hives was unknown. No follow-up attempts needed. No further information is expected.

Other Meds: MEGESTROL ACETATE

Current Illness: Fibroids; Ovarian cyst

ID: 1812472
Sex: F
Age:
State: OR

Vax Date: 05/11/2021
Onset Date: 05/11/2021
Rec V Date: 10/23/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 037K20A
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Headache, Limb discomfort, Nasal congestion

Symptoms: she started itching everywhere; had hives; she also had massive diarrhea.; Her injection site was also extremely painful/Injection site really sore and hurtful; She also had vision blurriness/Vision affected a little; shortness of breath; redness and spots; quite uncomfortable; This is a spontaneous report received from a contactable consumer (patient, self-reported) via medical information team. A 67-year-old female patient BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot/batch number: EW0183 and expiry date was not reported), via an unspecified route of administration in arm right, on 11May2021 at 12:45 PM (age at vaccination: 67 years), as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 11May2021, the patient experienced she started itching everywhere, had hives, she also had massive diarrhoea, her injection site was also extremely painful/injection site really sore and hurtful, she also had vision blurriness/vision affected a little, shortness of breath, redness and spots, quite uncomfortable. Clinical course was reported as female patient who received her 1st dose of the vaccine yesterday. within 2 hours after the injection the patient had itching everywhere and had hives. This proceeded to continue to the night, where she also had massive diarrhoea. Reportedly the patient injection site was also extremely painful, which made her quite uncomfortable. She also had vision blurriness and shortness of breath. The patient also stated that the itchiness was still there, but it was nothing like it was be-fore. The redness and spots have diminished but she was still itching to death. The patient also stated that they are better than last night but still ongoing. Reportedly the patient did not want to get the injection, but her family suggested it. The patient also stated that she has some health problems. No further information provided by the patient. Reportedly the patient just wanted to report her information that she was concerned about getting the second shot. States that she has multiple allergies, does not specify. Reported that that she spoke with her allergist before the first shot, and they told her to get the injection. Reportedly the patient was wondering if she should get the second injection. The clinical outcome of the event she started itching everywhere was not recovered, and other event redness and spots was recovered, and other events was recovering. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1812473
Sex: M
Age:
State: FL

Vax Date: 04/02/2021
Onset Date: 04/06/2021
Rec V Date: 10/23/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Back pain, Cold sweat, Headache, Nausea, Vomiting

Symptoms: face was red, scaly, and itchy; face was red, scaly, and itchy; face was red, scaly, and itchy; terrible rash with an allergy in his face it was dry, it was itchy, red; his face was swollen too; rash/it started on his face, it goes to his nose/below his belly button, like 4 inches to the right; terrible rash with an allergy in his face it was dry, it was itchy, red; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 79-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: ER8732) via an unspecified route of administration, administered in right arm on 02Apr2021 at 15:00 (at the age of 79-year-old) as DOSE 1, SINGLE, for COVID-19 immunization. Medical history included throat cancer from 2000 to an unknown date. Patient's concomitant medications were not reported. On 06Apr2021 after vaccination, the patient's face was red, scaly, and itchy. The patient also experienced terrible rash with an allergy in his face it was dry, it was itchy, red; face was swollen, and rash/it started on his face, it goes to his nose/below his belly button, like 4 inches to the right on 06Apr2021. It was reported that the patient's face was red, scaly, and itchy. He had a terrible rash with an allergy in his face. His face was swollen too. Rash/it started on his face, it goes to his nose/it started getting red and dry and then when he got up in the morning it was full blast completely/below his belly button, like 4 inches to the right/like a rash of the same type/rash on the face. He called his primary doctor and his doctor told him to rush to the emergency room; so he did not have any problem with his throat. He had throat cancer in 2000 and so now he had problems swallowing because of the radiation and so his doctor told him to rush to the emergency room before he has any more problems with his throat or with swallowing, so that's what he did. He went to the emergency room on 07Apr2021 because he had a terrible allergy. He did not go to the physician office. At the emergency room, they took his vitals and asked him questions and they gave him medicine and in one hour, he was out. They gave him 2 different medicines that he took for 14 days. The medicine they gave him worked and then 14 days later he was okay, he was back in good shape and the medicine worked. No investigation assessment was performed. His face was back to its normal. He has recovered completely from the rash. He would like to know if he should get the second dose due to the first reaction. The outcome of the events was resolved on an unspecified date in Apr2021. No follow-up attempts were needed. No further information was expected.

Other Meds:

Current Illness:

ID: 1812474
Sex: F
Age:
State: IL

Vax Date: 05/10/2021
Onset Date: 05/10/2021
Rec V Date: 10/23/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025j20-2A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data: Test Name: blood pressure; Result Unstructured Data: Test Result:high; Test Date: 20210510; Test Name: blood pressure; Result Unstructured Data: Test Result:drop; Test Name: Mammogram; Result Unstructured Data: Test Result:cyst on her breast; Test Name: pap smears; Result Unstructured Data: Test Result:good

Allergies:

Symptom List: Injection site swelling, Limb discomfort

Symptoms: She felt dizzy, weak, and tired.; She felt dizzy, weak, and tired.; She felt dizzy, weak, and tired.; Drop in her blood pressure; Right arm pain; headache; fever; she felt pressure on the top of her head, eyes, and nose; dizzy/states that if she stays in bed she is okay. If she gets up, it comes back; She felt like her ear was going to burst/Caller asks if it is okay to feel pressure going into her head from both ears like it is going to blow out; she felt pressure on the top of her head, eyes, and nose; she felt pressure on the top of her head, eyes, and nose; This is a spontaneous report from a contactable patient (patient). A 46-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0172), parenteral, administered in Arm Right on 10May2021 at around 12 or 12:30 (at the age of 46-year-old) as single dose for COVID-19 immunization. Medical history included cyst on her breast, it had been diagnosed since probably like 3 to 4 years. She thinks when she turned 40, or it was longer than that, she did not pay attention. Twice a year she gets a mammogram. She believes when she turned 40 it was her first mammogram and they found it. Her pap smears and everything have been good and she had a cyst on her breast that had been under control, it is not cancer or anything. When she was pregnant her last pregnancy her blood pressure went high. She ended up into a C-section. She had headache that time. She confirmed the high blood pressure with pregnancy was 12 years ago. She felt like her blood pressure went high up, up, up and she could not get it down and ended up having a C-section. She did not end up having problems and was on blood pressure medications for years, but everything was normal. The patient had no family medical history relevant to AEs, but her sister had a history of seizures. Concomitant medication(s) included ascorbic acid, ergocalciferol, folic acid, nicotinamide, panthenol, retinol, riboflavin, thiamine hydrochloride (MULTIVITAMINS) taken for an unspecified indication, start and stop date were not reported. She had been taking since more than 10 years or more. There was no history of previous immunization with the Pfizer vaccine considered as suspect and no vaccines administered on same date with the Pfizer vaccine considered as suspect. The patient had no other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s) and had no AEs following prior vaccinations. After she received the 1st dose, the patient felt dizzy, weak, and tired. When she sat on the chair, she said she noticed a drop in her blood pressure. In addition to this, she said she felt weak, and dizzy again, and this time it was accompanied by headache which she noticed when she went to work. She also said that between half an hour and an hour, she felt pressure on the top of her head, eyes, and nose. She felt like her ear was going to burst. She ended up going to the emergency room because she can no longer stand the dizziness. She mentioned that they were ruling out a blood clot so she had to see a neurologist. Later on confirmed that there was no blood clot. She also mentioned that she was afraid to get the 2nd dose but her doctor advised her to proceed with it. She did mention that she was feeling a little better today (11May2021). The patient reported that she got the shot last day (10May2021) and as soon as she got the shot she read the paper that they gave her that says what reactions are. She had to sit down because she got dizzy and a headache. She thought it was her blood pressure. She drove and went to work. She got back home and was feeling so tired and had a headache. She did not work on 11May2021 because she was still tired and had dizziness. She still had dizziness, was still tired, and still had headache. She had been in bed most the day. If she gets up or something, her head started going back. She felt so dizzy. She also had right arm pain, no redness or swelling. She did not know if there was swelling, there might be swelling now - she just feels like everything, like if she touches it or rubs it it hurts. The sore arm started after, 2 to 3 hours after she got the shot. The sore arm was still there. Not as much today as last day. It was still hurting. It did not hurt as much. Patient added that she did not read the paper yesterday as soon as she got the shot. She stood up, went to sit down, and felt dizzy. There was a doctor right there and she was going to ask the doctor to take her blood pressure. She felt like her body was shutting down and she was like damn, she never thought this was because of the vaccine. She did not read the paper they gave her until work. Then she realized that was what it was - she was so super tired and dizzy. Dizzy was the same. If she knew she was going to stay in bed - patient interrupts sentence and states that if she stays in bed she was okay. If she gets up, it comes back. She was going to get something to ate and she just did not want to get up. Patient added first came the dizziness and tiredness and headache right away. Tiredness started right away when she went down. Patient clarifies that she meant that when she sat down, like when she was going to sit down, she felt like she was getting sick like a fever that was icky. She felt like how it feels before someone gets a fever, icky, and that's how she felt. Patient added that the dizziness, tired, and headache all started the same. She did not know how to say it was a headache because it was like a pressure. Her ears were like when she was going to have an infection, it was pressure in her ears. The pressure in her head was on top of her head. Last day, when she got a headache, she believes when she was pregnant her last pregnancy her blood pressure went high. Patient cannot think of what it is called. She ended up into a C-section. That headache that time, she has never had it before, until yesterday. It was the same as years ago. But now it was just the top of her head. She did not end up having problems and was on blood pressure medications for years, but everything is normal. Now it was like, she felt the same pain in her head as she did before. Patient stated she received vaccination because it was a requirement, that it was required now and also she was going to see a doctor for pap smears and other things and they say she had to be fully vaccinated. She was not scared or afraid of the vaccine like other people were. She was not expecting to have those issues. Her pap smears and everything had been good and she had a cyst on her breast that had been under control, it was not cancer or anything. Other than that, she was going to see her doctor on 01Jun2021 to do, as far as she knows, she had no issues she knows of. Patient states that she only took Tylenol. Her coworker said take Tylenol and she had been taking it. She got a paper that she read and that was when she called and it said signs of allergy reaction. The word allergy reaction said hard breathing, swelling face and throat, and something with the heart, weakness which is what she feels, and dizziness. Patient confirmed she did not have these, just the weakness and the dizziness. No rash. No swelling. She felt dizzy and weak and her head. She had pressure that if she did not move she was fine. She did not know, maybe it was because she laying down. If she started doing stuff like she usually does, it comes back when she gets up as pressure. She just did not want to go to the hospital, she will just be so depressed if she does go to the hospital. She felt bad but she thinks she will feel good if she stays in bed. The patient may not get second vaccine: she states whatever right now, she just cannot stand it. She was scared of the second shot. If this happened now, she did not want to get the second shot. She did not feel well at all. She enquired if it was okay to feel pressure going into her head from both ears like it was going to blow out. She felt pressure again. The patient was informed that there is no information on low blood pressure, and pressure in the head, eyes, n

Other Meds: MULTIVITAMINS [ASCORBIC ACID;ERGOCALCIFEROL;FOLIC ACID;NICOTINAMIDE;PANTHENOL;RETINOL;RIBOFLAVIN;THI

Current Illness:

ID: 1812475
Sex: F
Age:
State: GA

Vax Date: 04/30/2021
Onset Date: 05/11/2021
Rec V Date: 10/23/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Chills, Diarrhoea, Fatigue, Feeling abnormal, Headache

Symptoms: her arm stayed sore for 3 days; States her arm is not sore, redness and bruising has gone down her arm some; it is a little worse than when she first noticed it; it is black and blue and under it on the sides and right in the back in the same area she is bruised; After a few days she developed 4 bruises around her left arm where she got the shot; has had blurriness in her vision; This is a spontaneous report from a contactable consumer. A 65-years-old female patient received first dose of bnt162b2 (Formulation: Solution for injection; Batch/Lot Number: EN6204), dose 1 via an un-specified route of administration, administered in Arm Left on 30Apr2021 as dose 1, single for covid-19 immunisation (at the age of 65-years-old). Medical history included myocardial infarction from 2018 to an unknown date, covid-19 from 2020 to an unknown date, asthma from an unknown date and unknown if ongoing. Concomitant medications included acetylsalicylic acid (ASPIRIN (E.C.)) taken for an unspecified indication, start and stop date were not reported. He has a caller on the other line who is a consumer, and she already reported the symptoms that she had from the Pfizer COVID vaccine for her 1st dose to the transfer agent. She got the 1st dose of the COVID vaccine on 29APR2021 and after a few days she developed 4 bruises around her left arm where she got the injection. Her second dose is scheduled on 21MAY2021. According to her she is taking a blood thinner, aspirin, and she also had a heart attack earlier this year. The caller was just asking if she can have the second shot since she had these symptoms and if this is a normal side effect of the COVID vaccine. Caller clarified that she had a heart attack in 2018 and she was on blood thinners after her heart attack, but her doctor took her off them last year, well actually it wasn't last year. She came off them in the early part of this year, 2021, because she was scared to come off the blood thinners because of the COVID hit in 2020 so she continued taking them and she came off them after she was able to go back to the doctor and see them. Her doctor told her to stop taking the blood thinner and she hasn't taken anymore in about 2 to 3 months. Would that still be in her system She wants to know if she will be able to take the 2nd shot. That's what she was concerned about. Will she bruise, have a bump or have a rash if she gets the 2nd dose Caller says that medical information transferred her to DSU to answer this question for her. She just wants to know if she will be okay because she had a mild case of COVID and she just doesn't want to go back into that situation again. That's why she took the COVID vaccine, but if she is going to bruise up like this, is it mandatory for the second dose or is it okay for her to take the second dose. Will she be alright. She says that she doesn't want to go back and forth being transferred. She said she will call her doctor after this phone call with the DSU agent. She doesn't want to go to the emergency clinic for them to just see a little bit of bruising but the only reason she was calling is because her daughter in law said that she didn't know that the caller was going to bruise like that. The caller is trying to convince them to go get the COVID vaccine so that they can be secure in their household but if she got that bruise from it then she thinks that they won't go through and take it. She was the first one that tried to get it done out of her household. Caller says that she goes to the hospital for her treatments and for her primary care but there is no telling who she might get as a doctor when she goes over there. Declined name, phone number and email. She says Pfizer can contact the hospital if they want to because she is about to as well. She said that the bruises showed up a couple days after she had the vaccine because her daughter in law first told her that she was bruised but she didn't pay much attention to it. The caller told her daughter in law that since she just got the COVID vaccine that she was going to be a little bruised from it, that's what the paper said. So, she left it alone and then this morning what made her call in is that her daughter in law said that the bruise is going down her arm and that she is bruised in more than just 1 spot. Caller says that she changed shirts and she then saw the bruises, but she also knows that her arm stayed sore for 3 days. She took Tylenol for it, and it is not sore now just bruised. She has no more soreness in her arm, she can move it around, but the first three days she couldn't do anything or even lift it to change night clothes. She didn't pay much attention until she saw the bruises going down her arm and she noticed that she has more than one bruise. Where the nurse shot her at it is black and blue and under it on the sides and right in the back in the same area she is bruised. Also she has had blurriness in her vision that started yesterday and she had it early this morning but it was like blackness going across her eyes on the right side. That's why she said as soon as she is off the phone with this DSU agent she is going to call the doctor for an appointment either today or tomorrow, but probably tomorrow. Caller says that the blurriness is coming and going. She really is not saying that she is sick, sick but she is just concerned about the bruises and if they will heal up. Because she had a mild case of the COVID at least that's what they said when she went to the hospital. She is an asthma patient and she couldn't really get her breath and she knew that she hadn't had an asthma treatment so she went to get one from the hospital and that's when they sent her butt home and told her to quarantine. She stayed sick for a month and a half, and it doesn't ever go away because she still has symptoms even after her quarantine. It is because they don't give you medicine for it. She was using her home remedies like honey, lemon, vitamin C and vitamin D to get her immune system up to par. She decided to go ahead and get the shot because she doesn't want that no more. You don't heal up from that, her smell never came back properly, and her taste never came back like it was before. That's why she decided to go ahead and get the COVID vaccine. Also, she has a 92-year-old mother who she hasn't seen, and she wants to be able to hug her and tell her she loves her. She didn't get the COVID vaccine because of word of mouth, it was because of her and her health and what she needs to do for herself. Confirmed that caller had COVID prior to the first dose of her COVID vaccine. She had COVID last year in 2020. Caller states she went and got the first dose of the Pfizer Covid vaccine, last week, and she is all bruised at the vaccination site. States it is red and bruised, that she noticed it on 9May2021, states she got the vaccine on 29APR2021. States her arm is not sore, redness and bruising has gone down her arm some, like someone has beat her, states it is a little worse than when she first noticed it. The outcome of the event bruises around her left arm where she got the shot was not recovered. The outcome of the events was blurriness in her vision, her arm is not sore, redness and bruising has gone down her arm some, it is a little worse than when she first noticed it, it is black and blue and under it on the sides and right in the back in the same area she is bruised was unknown, Outcome of the event arm stayed sore for 3 days was recovered. No follow-up attempts are needed. No further information is expected.

Other Meds: ASPIRIN (E.C.)

Current Illness:

ID: 1812476
Sex: M
Age:
State: MA

Vax Date: 05/07/2021
Onset Date: 05/01/2021
Rec V Date: 10/23/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 037K20A
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Hot flush, Myalgia, Nausea, Tension headache

Symptoms: Was sick; he vomited more bile than anything else.; bad stiffness in his joints; Every joint in body so stiff I could barely walk; This is a spontaneous report from a contactable consumer (patient). A 62-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EN0167, Expiry date was not reported) via an unspecified route of administration, administered in Arm Left on 07May2021 12:00 (age at vaccination: 62years-old) as DOSE 1, SINGLE for COVID-19 immunization. Patient also took diazepam (VALIUM) and prednisone via an unspecified route of administration from 07May2021 (Lot number was not reported) to an unspecified date, at unspecified dose for pinched nerve in his neck. Medical history included patient had hip surgery 4 weeks prior to receiving the vaccine, ongoing pinched nerve in neck from Apr2021, he pinched a nerve in his neck 3 weeks after his hip surgery in Apr2021 from walking with the walker and putting weight on his power side when he pinched the nerve in his neck that he felt the pain going down his arm and into his hand and fingers, ongoing Heart problem (he had a heart attack a couple of years ago and that he has a couple of stents), ongoing multiple allergies, ongoing breathing problems (he was diagnosed with a breathing problem years ago and his breathing problem is partly from smoking and allergies). Concomitant medication included fluticasone propionate, salmeterol xinafoate (ADVAIR HFA) taken for breathing problem. Amlodipine and atorvastatin both taken for heart problem, clopidogrel for blood thinner (all were began taking 2-3 years ago). Apixaban (ELIQUIS) for prone to blood clotting (began taking Eliquis about a year after his heart attack, roughly 2 years ago), fluticasone propionate FLONASE [FLUTICASONE PROPIONATE] taken for allergies (he has been using Flonase for a year or so), hydrochlorothiazide taken for unspecified indication which made patient go to the bathroom, losartan and metoprolol taken for heart problem (he began taking Losartan and metoprolol about 2 years ago), fluticasone propionate (PROAIR [FLUTICASONE PROPIONATE]) taking for breathing problem (he has been using ProAir for a couple years), montelukast taken for allergies (he started taking Montelukast about a year ago) and VITAMIN D [VITAMIN D NOS] taken for unspecified indication (he began taking vitamin D about a year and a half ago or 2 years ago at the most). All concomitant medication were ongoing and start date was unspecified. Patient did not receive any other vaccines within 4 weeks and no AE following prior to covid vaccine. No family medical history relevant to AE. On an unspecified date in May2021, the patient experienced bad stiffness in his joints, every joint in body so stiff he could barely walk, was sick and he vomited more bile than anything else. It was reported that 3.5 days after he received the first dose of the Covid-19 vaccine on 07May2021, every joint in his body was so stiff that it was difficult for him to walk and he was sick, that the joint stiffness was ongoing and improved. And he was sick for one occurrence and recovered completely. he vomited more bile than anything else, that he had not eaten his regular or normal diet. The joint stiffness has eased up that he was not where he was before he got the Covid-19 vaccine. he had been moving around and walking around his apartment with his walker. He was going to start therapy for his hip but cancelled because of the pain in his shoulder and he had to cancel the therapy appointment again because of the stiffness in his joints. Patient reported that he was prescribed Valium and Prednisone for the pinched nerve in his neck, that he didn't know if the joint stiffness could be a side effect of the medication he was prescribed at the emergency room and that he doesn't know if he was allergic to any of these medications or not. Patient was not visited any physician office or emergency room for any events. Patient stated that he did call his primary care physician about his stiff joints and his primary care physicians staff instructed to him to go see the physician who did the hip surgery. he did not call the physician that did his hip surgery because he knows they are going to tell him to go to the hospital. The outcome of the event Illness was recovered on an unspecified date in May2021, while the outcome of event vomiting was unknown and other events were recovering. No follow-up attempts are needed. No further information is expected

Other Meds: ADVAIR HFA; AMLODIPINE; ATORVASTATIN; CLOPIDOGREL; ELIQUIS; FLONASE [FLUTICASONE PROPIONATE]; HYDROCHLOROTHIAZIDE; LOSARTAN; METOPROLOL; PROAIR [FLUTICASONE PROPIONATE]; MONTELUKAST; VITAMIN D [VITAMIN D NOS]

Current Illness: Breathing difficult (he was diagnosed with a breathing problem years ago and is partly from smoking and allergies.); Cervical radiculopathy (he pinched a nerve in his neck 3 weeks after his hip surgery in Apr2021.); Heart attack (he had a heart attack a couple of years ago and that he has a couple of stents.); Multiple allergies

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am