VAERS 2021 Database www.vaers.hhs.gov

Main Page | All 2021 Deaths | Videos
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: 1793228
Sex: F
Age:
State: FL

Vax Date: 04/05/2021
Onset Date: 04/09/2021
Rec V Date: 10/16/2021
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: big welts come up; she can't sleep; She's weak; it gives her a break and feels stinging; misery and miserable pain from the itching/feels stinging; she has other illnesses; Sometimes she forgets but not as much as she does now; her head was hurting; She feels awful, and it's hard to think straight; Itching; She has been breaking out; dizzy; This is a spontaneous report from a contactable consumer (patient). A 82-years-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection, lot number: ER2613 and expiration date was not reported), second dose via an unspecified route of administration, administered in Arm Left on 05Apr2021 11:30 (at the age of 82-years-old) single for covid-19 immunization. Medical history included ongoing Blood pressure high (Verbatim: Blood pressure high), heart problems and pacemaker from an unknown date and unknown if ongoing. Patient previously took first dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection, lot number: EN6206 and expiration date was not reported) administered in Left arm on 15Mar2021 for covid-19 immunization. On 09Apr2021, the patient experienced itching, she had been breaking out and dizzy. On 10Apr2021, her head was hurting and she feels awful, and it's hard to think straight. On an unspecified date, the patient experienced big welts come up, she can't sleep, she's weak, it gives her a break and feels stinging, misery and miserable pain from the itching/feels stinging, she has other illnesses, sometimes she forgets but not as much as she does now. It was reported that the patient said that she will be in such misery and miserable pain from the itching. It had been keeping her up all night and she was not able to sleep. She had been breaking out. She rubs the area and big welts come up. She had always been weak, but she felt it more now. She was unsure when this feeling started, but it might be a week or more ago. Stated she had other illnesses and was not keep her house the way she would like to. The headache gave her a harsh pain and then it stopped. The pain was on and off. She had a lot of illnesses and takes 7-8 medication every morning. She had heart problems and had a pacemaker places about 7 years ago. She also had high blood pressure and had a problem with her blood and takes a blood thinner. She did not underwent for any tests. Stated they gave her that crazy shot. For treatment she used alcohol on the skin and that was the only think that would relief it. The prescription that the doctor gave her did not do anything. Triamcinolone 0.1 % cream, provided Rx-959987. No specific lot number provided when queried. Patient did not receive any additional vaccines and prior vaccinations (within 4 weeks). There were no patient medical history (including any illness at time of vaccination) and family medical history relevant to the events. Patient did not visit to Emergency Room for any events but she felt like she needed to go now to the Emergency Room for itching. Therapeutic measures were taken as a result of itching and big welts come up. Outcome of events big welts come up, she can't sleep, it gives her a break and feels stinging, misery and miserable pain from the itching/feels stinging, she has other illnesses, sometimes she forgets but not as much as she does now were unknown while itching, she has been breaking out, dizzy, her head was hurting, she feels awful, and it's hard to think straight and she's weak were not recovered. No follow-up attempts are needed. No further information is expected

Other Meds:

Current Illness: Blood pressure high (Verbatim: Blood pressure high)

ID: 1793229
Sex: F
Age:
State: OR

Vax Date: 03/31/2021
Onset Date: 04/03/2021
Rec V Date: 10/16/2021
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: First, I take several more Rx than space available to tell you. My reaction occurred 3 days after the injection. I had a fine all over body rash. It was quite red. Did not itch. Took 3 days to resolve; This is a spontaneous report from a contactable consumer(patient). A 61-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EP7533), via an unspecified route of administration on 31Mar2021 at 18:15(at the age of 61-years-old) administered in Arm Right as a single dose for COVID-19 immunisation at at Pharmacy or Drug Store. Medical history included HBP, a fib, 5yr s/p breast cancer, pituitary adenoma benign; allergies to Adhesive, contrast dye (all from an unknown date and unknown if ongoing). Concomitant medication(s) included bupropion; metformin; lamotrigine; modafinil; citalopram hydrobromide (PRAM) taken for an unspecified indication, start and stop date were not reported. The patient was not Pregnant at the time of vaccination. On 03Apr2021 at 15:30, it was reported that My reaction occurred 3 days after the injection. I had a fine all over body rash. It was quite red. Did not itch. Took 3 days to resolve. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.Therapeutic measures were taken as a result of event and took 10 mg Zyrtec per day after the first day of the rash. The outcome of the event was recovered. No follow-up attempts are needed. No further information is expected.

Other Meds: BUPROPION; METFORMIN; LAMOTRIGINE; MODAFINIL; PRAM [CITALOPRAM HYDROBROMIDE]

Current Illness:

ID: 1793230
Sex: M
Age:
State: PA

Vax Date: 04/06/2021
Onset Date: 04/07/2021
Rec V Date: 10/16/2021
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: Test Name: Blood test; Result Unstructured Data: Test Result:Normal; Comments: done in emergency room; Test Name: chest X-ray; Result Unstructured Data: Test Result:Normal; Comments: done in emergency room; Test Name: CAT scan; Result Unstructured Data: Test Result:Normal; Comments: done in emergency room

Allergies:

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

Symptoms: Shortness of breath irritated by problem he's having; trouble performing normal daily functions; Weak; Tired; Bit lightheaded; This is a spontaneous report from a contactable consumer (patient). A 83-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: ER8735) via an unspecified route of administration, administered in arm left on 06Apr2021 at 15:10 (at the age of 83-year-old) as DOSE 2, SINGLE for COVID-19 immunisation. Medical history included atrial fibrillation from 1987 to an unknown date (his last episode was in 2018), ongoing chronic obstructive pulmonary disease (COPD) for about 10 years maybe 2011 and ongoing sleep apnoea syndrome. The patient family medical history included his father died of a heart attack and his mother died from dementia like alzheimer's. Concomitant medications included salbutamol (ALBUTEROL HFA) taken for chronic obstructive pulmonary disease, start and stop date was not reported. He took albuterol whenever he was short of breath. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6204) via an unspecified route of administration, administered in arm left on 16Mar2021 as DOSE 1, SINGLE for COVID-19 immunisation. On 07Apr2021, the patient experienced weak, tired and bit lightheaded. Shortness of breath irritated by problem he was having and trouble performing normal daily functions on an unspecified date. On an unspecified date, the patient underwent lab tests and procedures which included in the emergency room blood test: normal, chest X-ray: normal and computerised tomogram: normal. It was reported that the patient underwent lab tests and procedures which included in the emergency room they did a urinalysis and took blood from him. He was sure there were 8 of the vials, and 4 of the little bottles took quite a bit of blood. He asked if they were giving someone a transfusion. They did a CAT scan of his head because they thought it might be a brain bleed. They did a chest X-ray and that was negative, he had no problem. They didn't even notice anything wrong with his COPD. Maybe they couldn't see it on an X-ray. The patient woke up in the morning at about 0900 he realized he was sick. Through the night he slept well. The patient had sleep apnea and had a CPAP on him at night with oxygen. When he woke up he felt short of breath which was unusual. When he woke up with the CPAP it almost processes it and takes care of the shortness of breath. He also had the oxygen. When he woke up he knew something was wrong. The patient took albuterol whenever he was short of breath and he had another medicine he took once a day, patient took a lot he had 13 prescriptions and then took some generic over the counter medications that doctors recommend. The outcome of the event weak and tired was recovering, bit lightheaded was not recovered, shortness of breath irritated by problem he's having and trouble performing normal daily functions was unknown. No follow-up attempts are needed. No further information is expected.

Other Meds: ALBUTEROL HFA

Current Illness: COPD (He has had COPD for about 10 years.); Sleep apnea

ID: 1793231
Sex: F
Age:
State: CA

Vax Date: 03/19/2021
Onset Date: 04/13/2021
Rec V Date: 10/16/2021
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: Caller states that there is a bumpy redness around 4 or 5 bump; She states that the deep throb feeling did wake her up, she was sleeping.; itchy bumps on inside of lower arm; deep throb at the site; This is a spontaneous report from a contactable consumer (patient). A 61-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN, G or 6, 204, Expiration date was not reported), dose 2 via an unspecified route of administration, administered in Arm Right on 19Mar2021 (age at vaccination 61 years) as dose 2, single, dose 1 intramuscular, administered in Arm Right on 26Feb2021 (Batch/Lot Number: EN6 or G 205) as dose 1, single for covid-19 immunisation. Medical history included None. Concomitant medication included escitalopram oxalate (LEXAPRO) taken for Anxiety. (she does not really remember how long she has been taking the product, 8 years maybe), estradiol (ESTRADIOL) taken for hormone replacement therapy, start and stop date were not reported (taking for about 10 years). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient not visited Emergency Room and Physician Office. It was reported Vaccine Administered at Military Facility. On 13Apr2021 03:00, the patient experienced deep throb at the site. On 13Apr2021 04:00, itchy bumps on inside of lower arm a few hours later. On an unspecified date, the patient had caller states that there is a bumpy redness around 4 or 5 bump, she states that the deep throb feeling did wake her up, she was sleeping on an unspecified date This was noticed about 3 or 4 am in the morning. Reporter stated, she felt she should report a delayed reaction to the vaccine that happened about a month after her second dose. Caller explains the throbbing lasted 10 or 20 seconds and then it was gone. It wasn't something that came and went. Topical cream on the area of the arm where the bumps are located, treatment except her fingernails. It was reported itchy bumps are different now, not as itchy and look like they have scabbed over, there is a bumpy redness around 4 or 5 bumps, and she would say they are healing since they scabbed up. They are taking their time to heal, the bumps. The outcome the event deep throb at the site was recovered on 13Apr2021 and itchy bumps on inside of lower arm was recovering and Caller states that there is a bumpy redness around 4 or 5 bump, Sleep disturbance was unknown. No follow-up attempts are needed. No further information is expected.

Other Meds: LEXAPRO; ESTRADIOL

Current Illness:

ID: 1793232
Sex: M
Age:
State: MA

Vax Date: 04/19/2021
Onset Date: 04/19/2021
Rec V Date: 10/16/2021
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: Left hand erythema/Lines in his hands seemed to be exaggerated; Left hand erythema/Lines in his hands seemed to be exaggerated; Upset stomach; Some diarrhea; Soreness in arm; His GI complaints started about maybe 2 to 3 hours after the vaccine.; Tingling in his scalp on the left side/Tingling on lateral aspect of abdominal wall; This is a spontaneous report from a contactable other hcp (patient). A 41-years-old male patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EW0162) via an unspecified route of administration on 19Apr2021 at 10:30 (at the age of 41-year-old) as dose 1, single for COVID-19 immunisation. The patient medical history included he has put on a few pounds from lockdown. Concomitant medications were not reported. History of all previous immunization with the Pfizer vaccine considered as suspect was reported as none. Historical vaccine reported as He has gotten flu shots. Additional vaccines administered on same date of the Pfizer Suspect was reported as none. Prior Vaccinations (within 4 weeks) was reported as none. Patient family medical history was reported as none. Relevant Tests reported as none. On 19Apr2021 the patient experienced left hand erythema/lines in his hands seemed to be exaggerated, tingling in his scalp on the left side/tingling on lateral aspect of abdominal wall, upset stomach, some diarrhea, soreness in arm, his gi complaints started about maybe 2 to 3 hours after the vaccine. It reported that about 4 to 6 hours later on the same side of his body that he had the shot he started having some symptoms. On his left hand he had some erythema, and the lines in his hands seemed to be exaggerated where the lines were deeper. He had tingling in his scalp on the left side. Also on the lateral aspect of his abdominal wall he had the same type of sensation. He didn't see anything on his abdominal wall and he didn't shave to see his scalp. It was reported that like his symptoms would appear and disappear over the course of a day. It was reported that 2 to 3 hours after he got the shot he had an upset stomach and some diarrhea. The patient stated that when his hand thing showed up his wife said it looked like it would be itchy. It was not itchy but he could tell it was not normal.It was not burning or itching but there was something wrong with his hand how he described. He is wondering if it is still safe to get the second shot. It was reported that the erythema was coming and going. It is weird how things were transient, and it was kind of rotating between 3 different spots. Other than the soreness everything has recovered completely. Patient not received treatment for the events. Outcome of the event soreness in arm was not recovered and other events was recovered on 19Apr2021. No follow-up attempts are needed. No further information is expected

Other Meds:

Current Illness:

ID: 1793233
Sex: F
Age:
State: IL

Vax Date: 04/19/2021
Onset Date: 04/19/2021
Rec V Date: 10/16/2021
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: Swollen lips with blisters; Swollen lips with blisters; Sore swollen gums; Sore swollen gums; flared ms symptoms, (i.e. hand trembling and band around chest),; flared ms symptoms, (i.e. hand trembling and band around chest),; Aching body; Fever; chills; Coughing; This is a spontaneous report received from a contactable consumer (patient) reported herself that. A 54-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot number: Ep7533) via an unspecified route of administration at right arm on 19Apr2021 13:00 (at the age of 53-year-old) as dose 2, single for COVID-19 immunisation. Medical history included CVID (Common variable immunodeficiency), MS (Multiple sclerosis), PE(s) (Pulmonary embolism), Allergies, Bone disease, Pacemaker, Wheelchair bound. Patient did not have covid prior to vaccination and post vaccination patient did not test COVID-19. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient received other medications within 2 weeks of vaccination. Patient do have allergies to medications, food and other products. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot number: Er8727) via an unspecified route of administration at right arm on 28Mar2021 13:00 (at the age of 53-year-old) as dose 1, single for COVID-19 immunisation. The patient experienced swollen lips with blisters, sore swollen gums, flared ms symptoms, (i.e. hand trembling and band around chest), aching body, fever, chills and coughing on 19Apr2021. Patient visit the physician office visit for the events. Outcome of all events was not recovered. No follow-up attempts are needed. No further information is expected

Other Meds:

Current Illness:

ID: 1793234
Sex: F
Age:
State: IL

Vax Date: 04/20/2021
Onset Date: 04/20/2021
Rec V Date: 10/16/2021
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 Date: 20210422; Test Name: Covid-19 Test; Test Result: Negative

Allergies:

Symptom List: Pyrexia, White blood cell count decreased

Symptoms: Feels like ear ache on right ear; Cough; Shortness of breath; Headache; Super runny nose; Hot and cold flashes; Sore throat - second dose; dripping sweat; felt like she was going to pass out; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 23-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: ER2613; Expiration Date: Jun2021, NDC number was not included on her Covid-19 vaccine records), second dose intramuscular route of administration, administered in Arm Left on 20Apr2021 at 12:45 (at the age of 23-years-old) as single for COVID-19 immunization. The patient was vaccinated at a household Pfizer event No Medical history and no other products were not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EK5730; Expiration Date: Mar2021), first dose intramuscular route of administration, administered in Arm Left on 30Mar2021 (at the age of 23-years-old) as single for COVID-19 immunization and experienced Sore throat (first dose: Caller reported that the sore throat went away in 36 hours. Patient reported that her sore throat started about 30 minutes after her first dose of the Covid-19 vaccine) and General body aches. The patient had no family medical history relevant to adverse events. The patient was not additionally administered vaccines, took no Prior Vaccinations (within 4 weeks). The patient had no adverse events following prior vaccinations. The patient got the second dose of the Pfizer Covid-19 vaccine a couple days ago on Tuesday, 20Apr2021, she was having a bad reaction to the Covid-19 vaccine, her reaction started with a sore throat a sore throat the same day (started a couple of hours after she received the second dose) that she got the Covid-19 vaccine (20Apr2021). she realized that on 20Apr2021 she was sweating and thought it was, had a cough that gets better and then gets worse just depending on if she was sitting near her humidifier, she will literally be dripping sweat (on an unspecified date in 2021) and then freezing during the hot and cold flashes, she did not realize that she was getting hot and cold flashes on 20Apr2021, that she thought she was just really hot. The hot and cold flashes started on Tuesday, 20Apr2021 but were not bad until Wednesday, 21Apr2021. On Wednesday, 21Apr2021, she started getting other symptoms. On Wednesday, 21Apr2021 when she started getting hot and cold flashes, and her headache (21Apr2021) was worse when she wakes up in the morning, she sounded congested (Super runny nose, on 21Apr2021), but her nose was not backed up at all, she was very concerned because it's very hard to breathe when she wakes up; she experienced shortness of breath (21Apr2021), she did not know if it was just a headache on that side that was causing the ear pain (22Apr2021) She felt like she was going to pass out (on an unspecified date in 2021). The patient further stated that everything that she read about online and the information she received with her Covid-19 vaccine, nothing has said anything about shortness of breath or cough or the symptoms that she had experienced. she went to the emergency room; she got 2 bags of fluids and was sent home; the emergency room staff instructed her to stay hydrated and hang out at home. She just did not know when or at what point she was supposed to go back to the hospital. The hospital staff told her that there was nothing that they can do besides maybe give her a breathing treatment for the shortness of breath, Events Shortness of breath, cough, sore throat, hot and cold flashes led to Emergency room. The patient underwent lab test and procedure which included Covid-19 test found to be negative on 22Apr2021. The events did not let the patient to Physician Office. she took ibuprofen (treatment) for her headache. she just moved and still needed to get a new primary care physician. The outcome of events dripping sweat and felt like she was going to pass out was unknown and of other events was not recovered. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1793235
Sex: M
Age:
State: WV

Vax Date:
Onset Date:
Rec V Date: 10/16/2021
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: chills; fever; This is a spontaneous report from a contactable other hcp(nurse). A male patient of an unspecified age received bnt162b2 ((PFIZER-BIONTECH COVID -19 VACCINE, formulation: solution for injection, Batch/Lot Number: Not Provided, expiry date: unknown) via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date the patient experienced chills, and fever. Patient went to facility and is having adverse reactions to the COVID 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: 1793236
Sex: M
Age:
State: CA

Vax Date: 04/12/2021
Onset Date: 04/01/2021
Rec V Date: 10/16/2021
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: Pain in back of chest, lung area; Pain he is experiencing in his chest is worse on the left side; Couldn't move; Felt very ill; Swollen lymph nodes on his neck; This is a spontaneous report from a contactable consumer (patient's mother). A 24-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number: unknown, expiry date and NDC number were not reported) via an unspecified route of administration on 12Apr2021 (at the age of 24-years-old) as dose 2, single for covid-19 immunisation. Medical history included ongoing asthma and he had this condition his whole life. This report was not related to a study or programme. Concomitant medication included fluticasone furoate, vilanterol trifenatate (BREO ELLIPTA) taken for asthma from an unspecified start date and ongoing. The patient's historical vaccine included first dose of BNT162B2 (COVID Pfizer vaccine; lot number was not reported) on an unspecified date for covid-19 immunization. The patient took covid vaccine because he is an essential worker. On an unknown date in Apr2021 the patient experienced pain in back of chest (lung area), swollen lymph nodes on his neck, couldn't move, felt very ill, pain he was experiencing in his chest was worse on the left side, the reporter said it was the side of his body as he got the vaccine on. The patient took a dose of his Breo Inhaler thinking that it would help. He had to miss work to go to the doctor about his symptoms. No investigation assessment. The outcome of the events chest pain, and lymphadenopathy was not recovered and for all other events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds: BREO ELLIPTA

Current Illness: Asthma (had this condition his whole life.)

ID: 1793237
Sex: F
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List: Diarrhoea, Nasal congestion

Symptoms: itchy and a burning sensation at the same time/ This sensation occurred with the first dose but resolved within a few days; itchy and a burning sensation at the same time/ This sensation occurred with the first dose but resolved within a few days; This is a spontaneous report from contactable consumer (patient). A 46-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 Vaccine, Solution for injection, Batch/Lot number was not reported) via intramuscular route on an unspecified date as dose 1, single for COVID-19 immunization. Medical history included urticaria or hives from cold water from an unknown date and unknown if ongoing. Concomitant medications were not reported. On an unspecified date, after first vaccination, the patient experienced itchy and a burning sensation at the same time. Reported that, the side effects were mild. The patient's lips, perioral area and eyes where one would usually apply eyeliner- though she doesn't apply make up, was itchy and a burning sensation at the same time. This sensation occurred with the first dose but resolved within a few days. The patient hypothesized that her side effects may be genetic because her brother and sister who live in other countries received Astra Zeneca and her sister developed hives and brother developed a wheel. Her 10-year-old son has also had to use an EpiPen several times. The outcome of the events were recovered on an unspecified date. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1793238
Sex: F
Age:
State: NC

Vax Date:
Onset Date: 04/24/2021
Rec V Date: 10/16/2021
Hospital:

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

Lab Data: Test Date: 20210424; Test Name: body temperature; Result Unstructured Data: Test Result:100.3

Allergies:

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

Symptoms: i had a fever of 100.3; when i woke up i had felt super tried; body aches; my arm that received the shot was very sore; This is a spontaneous report from a contactable consumer (patient). A 35-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, Lot Number: EW0170) via an unspecified route of administration in arm left on an unspecified date as dose 2, single for COVID-19 immunization. Medical history included blood clot (other medical history: blood clot for that she was taking eliquis for). The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and prior to vaccination, the patient was not diagnosed with COVID-19. The most recent COVID-19 vaccine was administered at school or student health clinic. Concomitant medication included apixaban (ELIQUIS) taken for thrombosis. The patient's historical vaccine included received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, Lot Number: EW0150) via an unspecified route of administration in right arm on 02Apr2021 16:30 as dose 1, single for COVID-19 immunization and experienced pain in arm. On 24Apr2021 07:30, the patient experienced fever of 100.3, when woke up, she felt super tried, body aches and her arm that received the shot was very sore. She was able to sleep it off and after 24 hours she was feeling 100 percent. On 24Apr2021 07:30, her body temperature was 100.3. No treatment was given for the events. The seriousness of the event was non-serious. On 25APR2021, the outcome of the events recovered. No follow-up attempts are needed. No further information is expected.

Other Meds: ELIQUIS

Current Illness:

ID: 1793239
Sex: F
Age:
State:

Vax Date: 03/19/2021
Onset Date: 03/19/2021
Rec V Date: 10/16/2021
Hospital:

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

Lab Data: Test Date: 2021; Test Name: Nasal Swab; Test Result: Negative

Allergies:

Symptom List: Rash, Urticaria

Symptoms: SOB; pain in right arm that radiated to right neck and shoulder; generalized itching; pain in right arm that radiated to right neck and shoulder; pain in right arm that radiated to right neck and shoulder; pain in right arm that radiated to right neck and shoulder; This is a spontaneous report from a contactable other healthcare professional (nurse, patient). A 45-year-old non pregnant female patient received BNT162b2 (Pfizer BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number and Expiration date was not reported) via an unspecified route of administration, administered in right arm on 19Mar2021 as dose 1, single (at the age of 45-years-old) for COVID 19 immunization (Hospital). Medical history included asthma and known allergies (both from an unknown date and unknown if ongoing) and COVID-19 (prior to vaccination) from an unknown date to unknown date. The patient's concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient had been tested for COVID-19, since the vaccination, via nasal swab and result was negative. On 19Mar2021 (began immediately after receiving injection), patient experienced generalized itching, shortness of breath (SOB), pain in right arm that radiated to right neck and shoulder. Events were reported to ED physician monitoring. Symptoms lasted for several days. Patient received no treatment for the events. The outcome of SOB was recovered on 23Apr2021, and rest of the events was recovered on an unspecified date in 2021. No follow up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1793240
Sex: F
Age:
State: PA

Vax Date: 04/06/2021
Onset Date: 04/06/2021
Rec V Date: 10/16/2021
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: Blood pressure decreased, Chest pain, Chills, Confusional state, Decreased appetite

Symptoms: full body chills and sweating (no fever at all); full body chills and sweating (no fever at all); severe joint pain started in legs (ankles/knees) and moved up to hands. elbows, shoulders and back; bruise/rash; bruise/rash; This is a spontaneous report from a contactable consumer or other non hcp. A 42-years-old non-pregnant female patient received (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, lot number: EP7533) via an unspecified route of administration, administered in Arm Right on 06Apr2021 13:30 (at the age of 42 years) as dose 2 single for COVID-19 immunisation at Pharmacy or Drug Store. Medical history included type 1 diabetes mellitus, osteoarthritis, hereditary spherocytosis, blindness from an unknown date and unknown if ongoing. Concomitant medications included insulin lispro (INSULIN LISPRO); metformin (METFORMIN) taken for an unspecified indication, start and stop date were not reported. Historical vaccine included first dose of BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, lot number: EP7534) via an unspecified route of administration, administered in Arm Right on 16Mar2021 13:30 (at the age of 42 years) dose 1 single for COVID-19 immunisation. She did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination she was not diagnosed with COVID-19. Since the vaccination, she has not tested for COVID-19. She was not pregnant at the time of vaccination. 3-4 hours after receiving 2nd dose of vaccine the patient experienced full body chills and sweating, severe joint pain started in legs and moved up to hands. elbows, shoulders and back which lasted about 16 hours, bruise/rash, on 06Apr2021 15:30 which appeared about 1 week after 2nd shot and was still there till 26Apr2021. No treatment taken for the adverse events. The outcome of the events was recovered on an unspecified date in Apr2021 and for events Rash and Bruise was not recovered. No follow-up attempts are needed. No further information is expected.

Other Meds: INSULIN LISPRO; METFORMIN

Current Illness:

ID: 1793241
Sex: F
Age:
State: NC

Vax Date: 04/16/2021
Onset Date: 04/16/2021
Rec V Date: 10/16/2021
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: Pain under right breast; Shortness of breath while walking long distance; Fast heartrate when walking; Gas problems; Rash on her face; Face swelled up around jaw part; Headache; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 60-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number: ER8729 and expiry date: unknown), via an unspecified route of administration in right arm on 16Apr2021 at 14:45 (at the age of 60-year-old) as a dose 1, single for covid-19 immunization at clinic facility. The patient medical history included she was diagnosed with migraines like tension in front from years ago; she had the high blood pressure first then had a pregnancy and ended up with diabetes years ago in 1995, all were ongoing. Family medical history relevant to events was reported as no. Concomitant medication included Lantus (insulin glargine) has been taking since couple of years to ongoing, she switched to Lantus from Levemir (insulin detemir); Novolog (insulin aspart) for the longest time, still ongoing; Ozempic (semaglutide) for 9-10 months weekly start date 2020 to ongoing; metformin 2x/day start date 1995 to ongoing; benazepril 4-5 months ago to ongoing; atenolol 1x/day for a couple of years to ongoing; Triamterene/HCTZ (hydrochlorothiazide, triamterene) 25 mg, 1x/day for a couple years to ongoing, reported that it was switched out from HCTZ and OMEGA 3 FISH OIL [FISH OIL], fish oil 1x/day for a while to ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. Adverse events following prior to the vaccinations was reported as no. History of all previous immunization with the Pfizer vaccine considered as suspect was reported as first dose and not applicable. On 16Apr2021, she has a headache, which goes on the back of her neck or the top of her head. On 18Apr2021, patient experienced rash on her face in the evening on the Sunday following her first vaccination, which was near the moles on her face and look like a circle as big as a dime, which has been there for over a week, she went to the dermatology doctor office because of rash, face had swelled up around the jaw part. It was reported that the, received the first dose on 16APR2021 and had a "bad reaction". She asked If she doesn't take the second dose, will she have a bad reaction? On 24Apr2021 (2 days ago from time of call on 26Apr2021), she had pain under her right breast comes and goes, and when it comes, it comes hard. She thinks that she was having gas problems and that she has never felt that pain before and she hasn't lifted anything to pull the muscle. Fast heartrate happened over the weekend of 24Apr2021 to 25Apr2021. On 25Apr2021 (last night), while she was walking around the house up and down the stairs, she had shortness of breath. She has not felt anything so far on 26Apr2021, and that she does not know if the fast heartrate was better or just the same and reported that she didn't have these problems until she got the Covid-19 vaccine shot and she was planning to not to take the second dose of the Covid-19 vaccine which scheduled on 07May2021, due to the symptoms and inquired if it will affect her in any way if she doesn't get the second dose of the Covid-19 vaccine. However, she was going to talk to her physician at the appointment tomorrow and she doesn't want to have to go through any more issues if she has to take the second dose of the Covid-19 vaccine. So, she was trying to eat light and not eat anything greasy so that she can get to her doctor. Dermatologist informed the patient that she doesn't know what was causing the rash and gave her antibiotics, but she was sceptical and did not take them. Dermatologist ruled out that the rash on her face could have resulted from irritation of the moles on her face. Vaccine administered at military facility was reported as no. Additional vaccines administered was reported as no. Patient has not visited to emergency room. Therapeutic measures included Tylenol (lot number: SSA111, expiration date: 22Oct2024 and UPC: 30043675) for her headache, which help a little bit but not much; migraines medication was prescribed but she has not taken it. Reporter seriousness for the events were unspecified. The outcome of the events headache, pain under right breast, gas problem, fast heartrate when walking and Shortness of breath while walking long distance were reported as not recovered and remaining all events were reported as recovering. No follow-up attempts are needed. No further information is expected.

Other Meds: LANTUS; LEVEMIR; NOVOLOG; OZEMPIC; METFORMIN; BENAZEPRIL; ATENOLOL; OMEGA 3 FISH OIL [FISH OIL]; TRIAMTERENE & HCTZ

Current Illness: Blood pressure high (she had high blood pressure first then had a pregnancy and ended up with diabetes years ago in 1995.); Diabetes (she had high blood pressure first then had a pregnancy and ended up with diabetes years ago in 1995.); Migraine (migraines like tension in front from years ago)

ID: 1793242
Sex: F
Age:
State: NJ

Vax Date: 04/07/2021
Onset Date:
Rec V Date: 10/16/2021
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: Antibodies; Test Result: Positive ; Comments: Tested Positive for antibodies by her pulmonologist

Allergies:

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

Symptoms: migraines; shortness of breath (sob); This is a spontaneous report from a Pfizer sponsored program via contactable consumer or other non hcp (patient) via medical information team. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, batch or lot number: was not reported), via an unspecified route of administration on 07Apr2021, as a single dose for COVID-19 immunization. The patient's medical history included covid 19 last year, May 2020, and had severe reactions. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced migraines, and shortness of breath (sob) and visited emergency room 2 or 3 times. On unspecified date, the patient underwent lab tests and procedures which included Antibodies, Cardiolipin antibody: Positive, Tested Positive for antibodies by her pulmonologist. Her 2nd vaccine dose was scheduled on 28Apr21, and her HCP referred her to poison control for information regarding how long she should wait to get her 2nd dose. Unaddressed medical questions referred or forwarded. 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: 1793243
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/16/2021
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: This is a spontaneous report from a contactable consumer or other non-HCP. A male patient, of an unspecified age, received the 2nd dose of BNT162B2 (Comirnaty, solution for injection, batch/lot# and expiration date: unknown), via an unspecified route of administration, on an unspecified date, for COVID-19 immunisation. The patient's medical history and concomitant medication not reported. Historical vaccine included the 1st dose of BNT162B2 (Comirnaty, solution for injection, batch/lot# and expiration date: unknown), single dose, for COVID-19 immunization. Patient stated he received both doses Pfizer COVID-19 vaccine. The second dose was 8 days ago. 1 or 2 days after it, he had joint pain: knees, elbow, shoulders, hands and back. He usually takes naproxen for that; but the vaccination providers said he could only take Tylenol or Aspirin (has not been helping, it just slightly lessens the pain). He takes Tylenol 3 times a day. The outcome of all events: unknown.

Other Meds:

Current Illness:

ID: 1793244
Sex: M
Age:
State: CA

Vax Date: 04/21/2021
Onset Date: 04/23/2021
Rec V Date: 10/16/2021
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: This is a spontaneous report from a contactable consumer (patient reported for himself). A 43-year-old male patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# unknown), at the age of 43, in left arm, via an unspecified route of administration, on Apr 21, 2021, at 13:00, single dose, for COVID-19 immunization. The patient's medical history and concomitant not reported. The patient has no known allergies. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not tested for COVID-19. On Apr 23, 2021, patient experienced allergy/rash (itches around stomach and waste line area). The patient did not receive any treatment for the events reported. The outcome of the events: not recovered. This follow-up is being submitted to notify that the batch/lot number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information expected.

Other Meds:

Current Illness:

ID: 1793245
Sex: F
Age:
State: VA

Vax Date: 04/15/2021
Onset Date: 04/15/2021
Rec V Date: 10/16/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Ear pain, Hypoaesthesia

Symptoms: I have hard breath & sleepy always please I need help in Emergency room couldn't find answer; I have hard breath & sleepy always please I need help in Emergency room couldn't find answer; This is a spontaneous report from a contactable consumer (patient). A 34-years-old non pregnant female patient received bnt162b2 (Solution injection; Batch/Lot number was not reported) via an unspecified route of administration, administered in Arm Left on 15Apr2021 at 12:00 (at the age of 34-years-old) as dose number unknown, single dose for COVID-19 immunisation. Medical history included food fruit allergy. There were no concomitant medications. Patient did not receive any other vaccines in four weeks. Patient was not diagnosed with covid prior to vaccination. Patient was not tested for covid post vaccination. On 15Apr2021 at 13:00, patient experienced to have hard breath and sleepy always please. Patient stated that she need help in emergency room couldn't find answer. Therapeutic measures were not taken due to the events. The outcome of the events was not recovered No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1793246
Sex: F
Age:
State:

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

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

Lab Data: Test Name: Fever; Result Unstructured Data: Test Result:104 Fahrenheit.

Allergies:

Symptom List: Abdominal pain upper, Dizziness, Dysgeusia

Symptoms: Chest pain; Fever, of 104; Vomit; Tired and exhausted; This is a spontaneous case received from a non-contactable consumer (patient). A female patient of unspecified age received second dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot# EW - Not legible), via an unspecified route of administration on 23Apr2021 as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medication was bot reported. Historical vaccine included first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot # ER 8727), via an unspecified route of administration on 02Apr2021 as dose 1, single for COVID-19 immunisation. The patient reported that after the second dose of the Pfizer COVID vaccine on Friday, 23Apr2021, about after 12 hours she had fever of 104, after 24 hours after the second dose she began to feel chest pain that moved to the middle of her chest. The patient experienced vomiting and her whole body was tired and exhausted. The patient did not receive any treatment for the event fatigue. 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: 1793247
Sex: M
Age:
State: GA

Vax Date: 04/21/2021
Onset Date:
Rec V Date: 10/16/2021
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: Asthma exacerbation; Cough; This Case has been made valid conservatively since patient experienced adverse events with Suspect product BNT162B2 in Follow up 01. This is a spontaneous report from a contactable other health care professional and nurse via Pfizer sponsored program. A 17-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: Not reported, Expiry date: Unknown), via an unspecified route of administration on 21Apr2021 as dose 2, single (at the age of 17-years-old) for COVID-19 immunisation. The patient medical history was not reported. Concomitant medications included oral steroids for asthma. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: Not reported, Expiry date: Unknown), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. Caller was not sure when the patient received the first dose, she did not get that date from the patient's mother. On an unspecified date, the patient experienced asthma exacerbation and cough. It was reported that he needed some oral steroids for an asthma exacerbation that had been going on for several weeks. Nurse didn't think the asthma flare up was due to the vaccine at all, but she wanted to know if there was any contradictions for giving oral steroids immediately following the second dose of vaccination. Nurse confirmed the asthma exacerbation was occurred prior to the first dose of the COVID-19 vaccine. It was not a severe exacerbation; he had been dealing with a cough for about 3 to 4 weeks. She did not believe that the cough was because of vaccine itself. The outcome of the events was unknown. No further details were provided or obtained. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1793248
Sex: F
Age:
State: VA

Vax Date: 03/06/2021
Onset Date: 04/01/2021
Rec V Date: 10/16/2021
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: itching; breathing difficulties/ immediate breathing problems; coughing; increased hearth rate; Overdose; Inappropriate schedule of vaccine administered; allergic reactions to food; vocal cords are limits her swallowing capacity; vocal cords are limits her swallowing capacity; This repeated and was more severe; This is a spontaneous report from a contactable female consumer (patient). A 57-year-old non-pregnant female patient received first bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EN6199), via an unspecified route of administration, administered in left arm on 06Mar2021 at 11:30 (at the age of 57-year-old) as dose 1, single for COVID-19 immunisation and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EK4176) via an unspecified route of administration, administered in left arm on 06Mar2021 (at the age of 57-year-old) as dose 2, single for COVID-19 immunisation. The patient's medical history included high blood pressure from an unknown date and unknown if ongoing. The patient had known allergies. The patient's concomitant medications were not reported. Prior to vaccination, patient was not diagnosed with COVID-19 and since the vaccination, patient had not been tested for COVID-19. Facility type vaccine was mentioned as other. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not covid prior vaccination and covid was not tested post vaccination. On 06Apr2021, immediate reaction was itching, breathing difficulties, coughing and increased hearth rate. Events overdose and Inappropriate schedule of vaccine administered. Emergency medical technician (EMT) was involved and administered two Benadryl pills and after 45 minutes patient was back to normal. This repeated and was more severe during the second dose of the vaccine. After two weeks, on an unspecified date in Apr2021, allergic reactions to food started. She can only eat very limited amount of bread cheese, and some select fruit. All other food caused itching, breathing problem and coughing. The patient went to a specialist and was prescribed allergy medication and the situation improved little. Whenever patient eats, companions will wait with Epipen and Benadryl pills. Her vocal cords limit her swallowing capacity and immediately breathing problems starts. These episodes last only 10-15 minutes but are increasingly concerned because if she experience these without any companion. Adverse event resulted in doctor or other healthcare professional office / clinic visit and Emergency room /department or urgent care and EMT and Doctor visit. The clinical outcome of events was not recovered and the events overdose and Inappropriate schedule of vaccine administered was unknown. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1793249
Sex: M
Age:
State:

Vax Date: 01/21/2021
Onset Date:
Rec V Date: 10/16/2021
Hospital:

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

Lab Data: Test Date: 2021; Test Name: Weight; Result Unstructured Data: Test Result:He is gaining weight; Comments: he is already obese.

Allergies:

Symptom List: Unevaluable event

Symptoms: fire/ red sun burn rash; His skin is peeling from head to toe/He has a scaling skin; His skin is peeling from head to toe; This is a spontaneous report from a contactable consumer (patient's son) reported for a patient. A 80-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on 21Jan2021 (age at vaccination was 80 years) as dose 1, single and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on 21Feb2021 (age at vaccination was 80 years) as dose 2, single for COVID-19 immunization. The patient's medical history included obese (he was already obese). The patient's concomitant medications were not reported. On an unspecified date in 2021, the patient developed a fire/red sun burn rash two days after his vaccine. He went to see a couple of specialists including an allergist who prescribed him prednisone. He had a scaling skin. The rash caused itchiness with prednisone it subsided. When he stops taking the prednisone it starts again. It was annoying to see him suffer like that. His skin was peeling from head to toe. The reporter didn't want the patient to take prednisone it made him hungry.On an unspecified date in 2021, he was gaining weight and he was already obese. The doctors said the rash should subside with time, but the reporter was worried and concerned. They were in May and they see no improvement. The reporter wanted to know more if anyone reported this kind of side effects and whether there was any medical treatment other than taking prednisone. The reporter received the response to discuss any alternative treatment plans with the patient's physician. 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: 1793250
Sex: M
Age:
State: FL

Vax Date:
Onset Date:
Rec V Date: 10/16/2021
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: fever; nausea; chills; headache; achy; This is a spontaneous report from a contactable consumer (Certified Nursing Assistant) reported for a male patient. A male patient of unspecified age received first dose of bnt162b2 (Pfizer COVID-19 Vaccine, solution for injection, Lot number: unknown), via an unspecified route on an unknown date as a single dose for COVID-19 immunization. Medical history included COVID-19. The patient concomitant medications were not reported. On an unknown date, patient had a reaction after his first Covid-19 vaccine. Details of the event was not known. Patient had a fever and reporter was surprised at that because he had Covid prior to the vaccine as well. He had nausea and fever and similar symptoms (achey, chills, headache) she (reporter) was experiencing. The patient had not undergone relevant medical tests. The clinical outcome of the events was unknown. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1793251
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/16/2021
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: Excessive redness in the right eye; 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 VACCINE, Formulation: solution for injection), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced excessive redness in the right eye on an unspecified date. Event took place after use of product. Outcome of the event was unknown. Reporter does not wish to be contacted for follow-up. No Follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1793252
Sex: M
Age:
State: FL

Vax Date: 01/27/2021
Onset Date: 02/01/2021
Rec V Date: 10/16/2021
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 work; Result Unstructured Data: Test Result:all came back fine; Comments: He has blood work every 3 months - all came back fine, cholesterol blood pressure and things of that nature

Allergies:

Symptom List: Injection site pain, Menorrhagia

Symptoms: completely round rash an inch wide on the opposite side of the injection spot that itches now and then but never goes away; This is a spontaneous report received from a contactable consumer (patient). A 75-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID -19 VACCINE, formulation: solution for injection, Batch/Lot Number: EL9262, expiry date: unknown) via an unspecified route of administration, administered in left upper arm on 27Jan2021 11:00 AM as dose 2, single for COVID-19 immunization (at the age of 75-year-old) at hospital. The patient's medical history and concomitant medications were not reported. No family medical history relevant to AE(s). The patient previously received BNT162B2 (PFIZER-BIONTECH COVID -19 VACCINE, formulation: solution for injection, LOT: EL1284 expiry date: unknown) on 06Jan2021 11:00 AM via unspecific route of administration in left upper arm as dose 1, 0.3 mL single, for COVID-19 immunization (at the age of 75-year-old). The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine, and no AE(s) following prior vaccinations. No additional vaccines administered on same date of the Pfizer suspect. On an unspecified date in Feb2021, within a week or less of the injection the patient experienced completely round rash an inch wide on the opposite side of the injection spot that itches now and then but never went away in the inside of his arm versus the outside part of his arm where he got the injections and it might had been 3 days, it was came back from 27Jan2021 and he knew it was only there from the second injection. It was reported that, it was not rough, it was smooth, no bumps. It was started 3-4 days after the injection, it was grown in size, it was redder and more irritating. He did not pay much attention it, if it had appeared a couple days after, he expected it to fade and it never really faded. He was not wearing different shirts or anything, he had been wearing the same one. It looked like a cause and effect from the vaccination. Patient took Pfizer COVID Vaccine to protect himself from the virus. On an unspecific date, the patient underwent lab tests and procedures which included blood count: all came back fine. He had blood work every 3 months all came back fine, cholesterol blood pressure and things of that nature. It was nothing related to the COVID vaccine. The patient had not visited the emergency room for the event. The event resulted in doctor or other healthcare professional office/clinic visit which includes he had seen a dermatologist for the event about 3 weeks ago, approximately, and he saw it, and said it is not like rashes he has seen with the vaccine and thought it was an irritation of some short. The outcome of the event was not recovered. No follow up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1793253
Sex: M
Age:
State: HI

Vax Date: 02/08/2021
Onset Date: 02/17/2021
Rec V Date: 10/16/2021
Hospital:

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

Lab Data: Test Name: Allergy test; Result Unstructured Data: Test Result:Normal; Comments: everything was fine; Test Date: 20210213; Test Name: Covid-19 test; Test Result: Negative ; Comments: Type: Other

Allergies:

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

Symptoms: I developed hives and rashes randomly on my body. Sometimes it looks like paintbrush stokes on my skin. Both types are extremely itchy.; I developed hives and rashes randomly on my body. Sometimes it looks like paintbrush stokes on my skin. Both types are extremely itchy.; I developed hives and rashes randomly on my body. Sometimes it looks like paintbrush stokes on my skin. Both types are extremely itchy.; Rashes; Paintbrush stokes of redness on his skin; The initial case was missing the following minimum criteria [Unidentifiable reporter]. Upon receipt of follow-up information on [27Apr2021], this case now contains all required information to be considered valid. This is a spontaneous report received from a contactable consumer or other non-health care professional (patient) via Pfizer-sponsored program Corporate (Pfizer). A 59-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number-unknown (not specified clearly) via an unspecified route of administration in left arm on 08Feb2021 (at the age of 59 years-old) as dose 2, single for COVID-19 immunization at hospital. The patient medical history was not reported. The patient had no known allergies. The concomitant medications included other medications taken within two weeks was simvastatin (ZOCOR) taken for an unspecified indication, start and stop date were not reported. Historical vaccine includes bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch no: not reported/Lot number- EL1283) via an unspecified route of administration in right arm (reported as right) on 11Jan2021 08:00 am (at the age of 59 years-old) as dose 1, single for COVID-19 immunization. No other vaccine taken within four weeks. Patient had not tested for covid prior vaccination and tested for covid post vaccination. It was reported that a week after his second dose on 17Feb2021, the patient had developed hives and rashes randomly on his body. Sometimes it looks like paintbrush strokes of redness on his skin, these hives/rashes are very itchy. Reported adverse events resulted in Doctor or other healthcare professional office/clinic visit. Both his allergist and dermatologist told him that it was his body reaction to the vaccine. The patient underwent lab tests and procedures which included sars-cov-2 test results negative for covid-19 on 13Feb2021 for type of other and on an unspecified date tested for Allergy test with normal results (everything was fine). No treatment received for adverse events. The outcome of all events was not recovered. No follow-up attempts are possible; Information about lot/batch number cannot been obtained. No further information is expected.

Other Meds: ZOCOR

Current Illness:

ID: 1793254
Sex: M
Age:
State:

Vax Date: 03/29/2021
Onset Date: 04/01/2021
Rec V Date: 10/16/2021
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: Swelling in neck; He thinks it is his lymph nodes that started on Wednesday and the swelling has not gone down yet; This is a spontaneous report received from a contactable consumer or other non-health professional (patient). A 49-year-old male consumer received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot number: Unknown) dose 1, Via an unspecified route of administration, administered in left deltoid on 29MAR2021 at 12:00 as a single dose for (at the age of 49 years old) for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Prior Vaccinations were none. On Apr2021 he has had swelling in his neck started late Tuesday and late Wednesday, and it comes and goes and he thinks it is his lymph nodes that started on Wednesday and the swelling has not gone down yet. Treatment include he has been taking Advil and that seems to help. Outcome of the event were not recovered. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1793255
Sex: F
Age:
State: MI

Vax Date: 04/15/2021
Onset Date:
Rec V Date: 10/16/2021
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: itching; tiredness; excessive urination; swelling of eyes; tight skin; puffy face; swelling all over her body; red bumps; This is a spontaneous report from a contactable parent reporting different events under the same suspect product for two patients. This is one of two reports: Reporting for 27-year-old female patient (daughter). A 27-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: ER8732), first dose via an unspecified route of administration, administered in left arm on 15Apr2021 at 09:00 (at the age of 27-year-old) as dose 1, single for COVID-19 immunisation at church. Medical history included ongoing arthritis, ongoing drug hypersensitivity, ongoing rubber sensitivity. There were no concomitant medications. No Investigation Assessment was reported. Report is not related to a study or program. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No additional vaccines administered on same date of the Pfizer suspect. No previous immunization with the Pfizer vaccine considered as suspect. No vaccine administered at military facility. The caller has three adult children who received the first dose of Pfizer COVID-19 vaccine on 15 Apr 2021 and two of the three children had reactions. One of the children is on the autism spectrum and the other just has orthopedic issues, but both had swelling all over their body and itching. This report is in regard to the caller's daughter, (Withheld). She confirms her daughter has orthopedic issues. She has a lot of allergies and is allergic to a lot of medications. They suspected she may have issues with the vaccine. She explains her children didn't have any noticeable reactions on site during their vaccination appointment which was like 9am, but by the time they got home, her daughter was like "Mom, I'm starting to itch all over", so she started her on the Benadryl. First, the caller tried to call the local health department and was directed to their family physician. So, she called the family physician, she reported it. She was told as long as it didn't feel like her daughter's throat was swelling or closing, to continue with the Benadryl every 8 hours and monitor her, and the same with her son. Her daughter started complaining of itchiness at like 4 am the next day, she came into the caller's room and was like "Mom, I'm itching like crazy and swollen all over". Her daughter showed the caller how tight her hands were and how puffy her cheeks were. As soon as their doctor's office opened the next morning, the caller did report both of her children's experience. She confirms her daughter had serious itching. The caller did not see any redness on her daughter or splotching, but her daughter was itchy. She could see some little red bumps on her daughter's skin, but nothing significant. The caller's daughter was also complaining about how tired she was. Her daughter said to the caller, "I was so tired I did not think I ate dinner". Her daughter came down at 4:00 to speak with the caller and her husband and tell them what she was experiencing. Her daughter said, "I just felt so tired all I could do was sleep". So, her daughter felt the tired sensation on day 1 of receiving the vaccine. Her daughter did tell the caller she had to pee a lot in the night. She confirms her daughter had no swelling of the eyes, but she did feel the swelling all over her body. Her daughter has a very fair complexion, so the caller could see how tight her skin was, how super puffy her face was, her stomach was. The caller could just see the swelling, just like with her son. It was very apparent. The caller's daughter did not complain that her throat was closing. She does have an EpiPen because she was allergic to everything under the sun or that one could think of. She clarified her daughter has seasonal allergies, any kind of bug allergy, she has had allergic reactions to medications. She mentions her daughter had an allergic reaction to a pain medication the doctor gave when she had her wisdom teeth pulled and she was taken to the hospital. Her daughter is allergic to Penicillin. She clarifies her daughter is allergic to any "-penicillin" or "-statins". No other details provided by caller. She got a bee bite sting, and that lead to hospitalization. Before her children got their injections, the caller asked was anything that they were doing have latex because all of her children have latex allergies as well. The caller was informed there was no latex was used at the vaccination site. Caller confirms she also has a latex allergy. Her daughter is still itching. It has lasted the entire week. She confirms all her daughter's symptoms are continuing today. She confirms, her daughter has no lip swelling, but she is still complaining of itchiness. She mentions her daughter is deathly afraid to get part 2 of the vaccine. She doesn't know what is going to happen. She did tell the nurse on site how she had an adverse reaction to the nasal flu vaccine. That was a hospitalization, too, but she had other flu injections with no reactions. When providing the Lot number, the caller mentions the second letter looks like a "K", but she believes the second letter is an "R" as she compares the Lot number to her son's vaccine record card. She confirms Lot number was " ER7832". Withheld has no medical history or takes anything that was related, but she takes amlodipine and metoprolol, but that's it, other than taking Zyrtec or Cetirizine if she has seasonal allergies. The doctor told her daughter to just take Tylenol for other discomforts/achiness she felt during these reactions. It was reported that the caller has three adult children who received the first dose of Pfizer COVID-19 vaccine on 15 Apr 2021 and two of the three children had reactions. Both children had swelling all over body, itching. She confirms her daughter had no swelling of the eyes, but she did feel the swelling all over her body. Her daughter has a very fair complexion, so the caller could see how tight her skin was, how super puffy her face was, her stomach was. The caller called the family physician, she reported it. She was told as long as it did not feel like her daughter's throat was swelling or closing, to continue with the Benadryl every 8 hours and monitor her, and the same with her son. The doctor told her daughter to just take Tylenol for other discomforts/achiness she felt during these reactions. Her daughter is still itching. It has lasted the entire week. She confirms all of her daughter's symptoms are continuing today. She confirms, her daughter has no lip swelling, but she is still complaining of itchiness. The events had not resulted in for death, life-threatening, prolonged hospitalization, disabling/incapacitating or Congenital anomaly/birth defect. Adverse event did not require a visit to emergency room and physician office, just a phone call to the doctor. No relevant tests were performed. The outcome of the event excessive urination was reported as unknown and rest all events were reported as not resolved. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness: Arthritis; Latex allergy; Penicillin allergy.

ID: 1793256
Sex: M
Age:
State: NJ

Vax Date:
Onset Date:
Rec V Date: 10/16/2021
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: Test Name: numerous lab reports; Result Unstructured Data: Test Result:inconclusive; Comments: numerous lab reports that were all inconclusive

Allergies:

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

Symptoms: rash; This is a spontaneous report from a contactable male consumer(patient) reported for himself. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date were not reported) an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date patient experienced rash. The patient stated that he had what he suspect was rash from Pfizer Vaccine and his current dermatologist said only that it was unusual then left me hanging for the next month without any explanation for the numerous lab reports that were all inconclusive his lack of concern was unacceptable. Fortunately, the rash was finally went away, outcome appears resolved on its own. The outcome of the event was recovered. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1793257
Sex: M
Age:
State: PA

Vax Date:
Onset Date:
Rec V Date: 10/16/2021
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: got sick; fever; chills; couldn't walk upstairs; This is a spontaneous report from a contactable other health professional received from a Pfizer COVID Vaccine Program. An adult male patient in his forties received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: unknown, Expiration date was not reported), via an unspecified route of administration on an unspecified date as a dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient got sick, fever and chills. It was reported that, the reporter has not seen anybody, they've, like, started to pull weird stuff that have happened three weeks later, there's like a, an, uh, obstetrician who had some blood platelet thing and they're trying to figure it out. But they're not really sure if it's related. They stated that, old people usually don't have a side effect. Stated that, [name other] got sick after the second one, too. Stated that, he got chills, fever and got sick after the second one. Stated that, dr had to send home the other day as the patient couldn't walk upstairs. The outcome of events was unknown. The causality was reported as related. No follow-up attempts are possible, information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1793258
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/16/2021
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: Injection site pain

Symptoms: swole up; This is a spontaneous report from a Pfizer sponsored program. A non-contactable consumer reported that a 77-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date (at the age of 77-year-old) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included sensitivity (not allergy) to iodine, penicillin which goes away by itself. The patient's concomitant medications were not reported. The patient previously took sulfur and experienced sensitivity which goes away by itself. On an unspecified date, the patient experienced swole up. When they went to see into her heart they gave her a lot of stuff, she swole up, they didn't tell her 100% that it was caused by the iodine. Also, an injection with painkillers made her swell up once. The outcome of event 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: 1793259
Sex: M
Age:
State: FL

Vax Date: 04/13/2021
Onset Date: 04/01/2021
Rec V Date: 10/16/2021
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: Painful burn / rash all over hands; Painful burn / rash all over hands; He has brown spots on the tops of his hands.; The burn are did go to his other pointer/index finger and across his other fingers; Everywhere he had the sores it's been peeling and he has these bright pink spots all over his hands; he couldn't even lift his arm up; sleeps on his left side and he couldn't sleep the night he got the vaccine; his arm was super painful; He felt so mad; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 32-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; Lot Number: ER8729), via an unspecified route of administration, administered in left arm on 13Apr2021 (at the age of 32-year-old) as dose 1, single for an COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 13Apr2021, he reports he sleeps on his left side, and he couldn't sleep the night he got the vaccine. On 15Apr2021 the patient experienced painful burn / rash all over hands, he has brown spots on the tops of his hands, the burn are did go to his other pointer/index finger and across his other fingers, everywhere he had the sores it's been peeling and he has these bright pink spots all over his hands, he couldn't even lift his arm up, and on unknown date in Apr2021 his arm was super painful and he felt so mad. It was reported that, he's left-handed and the day he received the COVID 19 vaccine was the worst day, he couldn't even lift his arm up. His arm was super painful. He tried to sleep on his back, and he'd roll over onto his arm and wake up in pain. He took pictures of his hands every day. He has pictures to show. He took pictures of his hands to a friend of his who was an emergency room doctor and his doctor friend told him that he's definitely having a reaction to the COVID 19 vaccine. He went back to the facility that gave him the COVID 19 vaccine and the person at that facility told he should not get the second vaccine and that he should see his primary care doctor. He sent these pictures to his doctor friend. The clinical outcome of the event painful burn / rash all over hands, was not revered and while the outcome of other events was unknown. No follow-up attempts are possible; No further information is expected.

Other Meds:

Current Illness:

ID: 1793260
Sex: F
Age:
State:

Vax Date: 04/14/2021
Onset Date:
Rec V Date: 10/16/2021
Hospital:

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

Lab Data: Test Name: body temperature; Result Unstructured Data: Test Result:Temperature

Allergies:

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

Symptoms: Headache; Temperature; This is a spontaneous report from a Pfizer sponsored program via a non-contactable consumer (patient) reported for herself. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on 14Apr2021 (age at vaccination was unknown) as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced headache and temperature. The patient wanted to know if she has to get the second dose of vaccine as she experienced side effects of headache and temperature following the first dose on 14Apr2021. 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: 1793261
Sex: M
Age:
State: NJ

Vax Date: 04/22/2021
Onset Date: 04/22/2021
Rec V Date: 10/16/2021
Hospital:

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

Lab Data: Test Name: PCR; Result Unstructured Data: Test Result:Unknown result; Comments: he is still waiting for result.

Allergies:

Symptom List: Tremor

Symptoms: fever; discomfort as well as breathing; discomfort as well as breathing; he experiences a shortness of breath; This is a spontaneous report from a Pfizer sponsored program. This contactable male consumer (Patient) reported for himself that: A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: unknown), via an unspecified route of administration on 22Apr2021 as DOSE 1, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 22Apr2021 after the vaccination, the patient experienced a shortness of breath. On an unspecified date, the patient experienced fever and discomfort as well as breathing. On an unspecified date, the patient underwent lab tests and procedures which included PCR test: unknown result (he was waiting for the result). It was reported that, patient had his 1st shot this 22Apr2021. He did some workout in the gym after taking it, then after getting home, he experiences a shortness of breath that was about 45mins, the day after which was Friday, he felt fever and discomfort as well as breathing. On the same day, he actually did a PCR test, and he was still waiting for the result. Patient was concerned if those experiences was from COVID-19 or from the vaccine. Unaddressed medical questions were not referred or forwarded to Medical Information. The outcome of events was reported as unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1793262
Sex: F
Age:
State: PA

Vax Date: 03/23/2021
Onset Date: 03/23/2021
Rec V Date: 10/16/2021
Hospital:

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

Lab Data: Test Date: 20210423; Test Name: COVID-19; Result Unstructured Data: Test Result:Negative; Comments: Nasal swab.

Allergies:

Symptom List: Erythema, Pruritus

Symptoms: disoriented; dizzy; I felt drunk; Patient was also having paranoid thoughts; chills; nausea; forgetfulness; slightly depressed mood; fatigue; This is a spontaneous report from a contactable consumer(patient). A 49-years-old non pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: Zn6208), via an unspecified route of administration, administered in arm left on 23Mar2021 (at the age of 49-years-old) as dose 1, single for COVID-19 immunisation. Medical history included OA HTN PMDD (premenstrual dysphoric disorder), food allergy, gluten sensitivity, dairy intolerance. The patient had COVID prior vaccination. Concomitant medication included sertraline hydrochloride (ZOLOFT), bupropion hydrochloride (WELLBUTRIN), lisinopril, cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE], vitamin c [ascorbic acid], colecalciferol (VITAMIN D [COLECALCIFEROL] (taken for an unspecified indication from an unspecified start date to an unspecified stop date). Patient was not pregnant at the time of vaccination. Patient reported after her first dose, later in the day, on 23Mar2021 at 20.00, the patient experienced disoriented, dizzy, felt drunk. It lasted for several hours. Patient was also having paranoid thoughts. Patient had to ask her husband to pick her up because she did not think she could drive. After that patient had the effects that most people report chills, nausea, forgetfulness, slightly depressed mood, fatigue, etc. The patient received Psych care treatment for the events. On 23Apr2021 patient underwent lab tests and procedures which included sars-cov-2 antibody test: negative (nasal swab). The patient had COVID test post vaccination. The outcome of the events was not recovered. No follow-up attempts are possible. No further information is expected.

Other Meds: ZOLOFT; WELLBUTRIN; LISINOPRIL; ZYRTEC [CETIRIZINE HYDROCHLORIDE]; VITAMIN C [ASCORBIC ACID]; VITAMIN D [COLECALCIFEROL.]

Current Illness:

ID: 1793263
Sex: F
Age:
State: WI

Vax Date: 02/18/2021
Onset Date:
Rec V Date: 10/16/2021
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: pain in joints; Pain in joints and spine; This is a spontaneous report from a contactable consumer or other non hcp. A 80-year-old female patient received second dose of BNT162B2 (COMIRNATY, solution for injection, lot number EN5318 and expiry date was not reported), via an unspecified route of administration, in Arm Right on 18Feb2021(at the age of 80-year-old), as Dose 2,Single for COVID-19 immunization at hospital. Historical vaccine included first dose of BNT162B2 (COMIRNATY, solution for injection, lot number EN5318 and expiry date was not reported), via an unspecified route of administration, in Arm Right on 28Jan2021 at 10:45 as Dose 1,Single for COVID-19 immunization. The patient medical history included hypersensitivity (allergies) since childhood and still ongoing, drug hypersensitivity (Allergy to IVP dye) from 1970 and ongoing since 1st administered, obesity from 1989 and ongoing, coronary artery disease from an unspecified date and still ongoing. Concomitant medications included valsartan from past 20 years and ongoing, atorvastatin from past 10 years and ongoing and metoprolol from past 20 years and ongoing, all taken for an unspecified indication. On an unspecified date, the patient experienced pain in joints and spine. Outcome of the events was unknown. No follow-up attempts are needed. No further information is expected.

Other Meds: VALSARTAN; ATORVASTATIN; METOPROLOL

Current Illness: Allergic reaction NOS (since chidhood); Allergic reaction to drug (Allergy to IVP dye since 1st administered); Coronary artery disease; Obesity

ID: 1793264
Sex: F
Age:
State: GA

Vax Date: 04/22/2021
Onset Date: 04/22/2021
Rec V Date: 10/16/2021
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: Swelling of face; Slight rash on face; This is a spontaneous report from a contactable consumer (patient). A 21-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER8737), via an unspecified route of administration, administered in arm left on 01Apr2021 (age at vaccination was 21 years) as DOSE 1, SINGLE and second dose of bnt162b2 (Batch/Lot Number: EW0158), via an unspecified route of administration, administered in arm left on 22Apr2021 at 12:00 PM (age at vaccination was 21 years) as DOSE 2, SINGLE for covid-19 immunisation at other facility. The patient was not pregnant at the time of vaccination. Medical history was none. No known allergies reported. Concomitant medications were not reported. No other vaccines were received within four weeks prior to the COVID vaccine. No other medications received within 2 weeks of vaccination. On 22Apr2021 at 09:00 PM, the patient experienced swelling of face and slight rash on face. The events resulted in visit to emergency room/department or urgent care. Therapeutic measures taken as a result of the events included treatment with Benadryl 25mg every 6 hours. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not tested for COVID-19. Outcome of the events was recovering. Follow-up (21Jun2021): Follow-up attempts completed. No further information expected.

Other Meds:

Current Illness:

ID: 1793265
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/16/2021
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: having some bleeding on the administration site of the vaccine; might have considered that they have hit a wrong vessel; This is a spontaneous report from a contactable Pharmacist reported for a consumer (patient). A 50-years-old female received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on an unspecified date (age at vaccination was unknown) as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on an unspecified date (age at vaccination was unknown) as dose 1, single for COVID-19 immunization. On an unspecified date, the patient had some bleeding on the administration site of the vaccine. The reporter wanted to get recommendations as to the administration of a possible third dose (it's safety and possible timing) to a patient who feared that they might not get the recommended dose to elicit full efficacy of the PFIZER-BIONTECH COVID-19 VACCINE following that her 2nd dose was administered on a manner where she bleed. Immunizing authority might have considered that they have hit a wrong vessel upon the administration of the vaccine, thus the bleeding on the patient's end. Now, patient was suggesting to have a 3rd dose as she was afraid that vaccine came out alongside with her blood. The reporter also gave an additional information that they would consider these events normal and not report this because on his own opinion, having some bleeding on the administration site of the vaccine didn't merely state that the vaccine/drug comes out of alongside with it. However, he only would like to be certain about this. The reporter wanted to know if patients receiving 2nd dose of the PFIZER-BIONTECH COVID-19 VACCINE who did not experienced any side effect should be concerned about vaccine efficacy. 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: 1793266
Sex: F
Age:
State: IL

Vax Date: 04/08/2021
Onset Date: 04/08/2021
Rec V Date: 10/16/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: hives are on her face, arms, legs, stomach, chest, back, and neck; itched all night; hives are around her eyes, the right side of her face it is splotchy and swollen; person who gave Covid-19 injection said she hit a blood vessel in the patient's arm. It bled a little bit more; person who gave Covid-19 injection said she hit a blood vessel in the patient's arm. It bled a little bit more; This is a spontaneous report from a contactable consumer (mother). A 19-years-old female patient (daughter) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: ER8731) intramuscular in left deltoid on 08Apr2021 at 13:30 pm (at the age of 19 years) as dose 1, single for COVID-19 immunization. Medical history included hypothyroidism from 22Aug2016 and ongoing, oesophageal atresia from 04Feb2002 to 09Feb2002 (Pertinent Details: Esophageal atresia repair and tracheoesophageal fistula Repair 05Feb2002), tonsillitis from 05Jun2005 to 05Jun2005 (Pertinent Details: Tonsillectomy and Adenoidectomy 05Jun2005), migraine from 2005 to an unknown date (Pertinent Details: Controlled), vitiligo from 2016 to an unknown date, polycystic ovaries from 05Dec2020 and ongoing, covid-19 from 21Dec2020 to an unknown date, contraception. Concomitant medications included levothyroxine sodium (EUTHYROX) taken for hypothyroidism from 2017 to an unspecified stop date; desogestrel, ethinylestradiol (ENSKYCE) taken for contraception from 2019 to an unspecified stop date. No prior vaccinations within 4 weeks. The patient previously took doxycycline and experienced hives (it happened years ago). On 08Apr2021 at 13:30, it was reported that the person who gave the Covid-19 injection said she hit a blood vessel in the patient's arm. It bled a little bit more. After she put a Band-Aid on it, her arm was ok. On 09Apr2021 at 09:30, the patient experienced hives on her face, arms, legs, stomach, chest, back, and neck. On 09Apr2021, the patient experienced hives are around her eyes, the right side of her face it was splotchy and swollen, itched all night. It was reported that patient got hives the day after she received the vaccine. She was initially taking 2 Benadryl (treated with Benadryl for 2 weeks) in the morning and 2 Benadryl (25mg tablets Lot number: AAF101, Expiry date Oct2022) at night and that wasn't helping. She went to her doctor yesterday, 19Apr2021 and the doctor put her on Prednisone 50mg (for 1 week). Once the Prednisone wears off the hives were coming back with a vengeance. Patient took her first dose of Prednisone yesterday morning at 10:00AM. By 10:00PM last night the hives were back, all over her face and the hives were worse than what they were before. Reporter reported that the hives were on patient face, arms, legs, stomach, chest, back, and neck. Patient didn't think she's getting the second vaccine. Obviously she's allergic to the Covid 19 vaccine. Patient worked last night, 20Apr2021 and the hives started coming back on her face around 10:00PM. She got off work and lives minutes away. Her hives were getting worse by the second. Patient took half a Prednisone pill and 2 more 25mg Benadryl. That didn't even work, she itched all night. The hives were around her eyes, the right side of her face, it was splotchy and swollen. Patient went back to physician's office, they prescribed Prednisone again with a lower dose for a longer timespan. This did not help. Patient returned to Physician's office, in addition to previous prescription, they added montelukast. The hives were currently controlled by taking of 2 claritin and montelukast daily. The outcome of the events hit a blood vessel in the patient's arm, it bled a little bit more was recovered on unspecified date in 2021, hives on her face, arms, legs, stomach, chest, back, and neck was recovering while for the other evens was unknown. Follow-up attempts are completed. No further information is expected.

Other Meds: EUTHYROX; ENSKYCE

Current Illness: Hypothyroidism; Polycystic ovaries

ID: 1793267
Sex: F
Age:
State: CT

Vax Date:
Onset Date:
Rec V Date: 10/16/2021
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: bruisingon the neck; Experienced fatigue; This is a spontaneous report from a Pfizer sponsored program Support. A contactable female consumer (Patient) reported for herself: A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown), via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were unknown. On an unspecified date the patient experienced bruising on the neck and fatigue (after getting second dose). 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: 1793268
Sex: F
Age:
State: NY

Vax Date: 04/16/2021
Onset Date: 04/27/2021
Rec V Date: 10/16/2021
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: This is a spontaneous report from a contactable consumer or other non-HCP (patient). A 34-year-old (non-pregnant) female patient received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection, batch/lot# EW0161), at the age of 34, via an unspecified route of administration, in left arm, on Apr 16, 2021, at 10:15, single dose, for COVID-19 immunisation. Medical history: none. The patient has no known allergies. The patient's concomitant medications not reported. The patient previously took the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection), on an unspecified date, single dose, for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not tested for COVID-19 since the vaccination. On Apr 27, 2021, at 08:00, patient had a very big inflammation in her left armpit. It hurts and she was worried about it, since she will most likely need a mammogram to study the case. She read it might be linked to COVID-19 vaccine effects and wanted to report it in order to make the right diagnosis and treatment. No treatment received for adverse events. She was asked for further studies to identify the reason for the bump and if is a reaction from the vaccine or something else. Reportedly, the event took place after use of product. The outcome of events: not recovered. No follow-up attempts needed. No further information expected.

Other Meds:

Current Illness:

ID: 1793269
Sex: F
Age:
State: KS

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

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

Lab Data:

Allergies:

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

Symptoms: Red bumps to her legs and neck and they are itchy; red bumps to her legs and neck and they are itchy; This is a spontaneous report from a contactable consumer (patient) via Pfizer-sponsored program Support. A female patient of an unspecified age received second dose of 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 23Apr2021 09:00 as dose 2, single for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: Not reported, Expiration Date: Not reported), via an unspecified route of administration on 02Apr2021 as dose 1, single for covid-19 immunisation. On an unspecified date, the patient experienced red bumps to her legs and neck and they are itchy. Caller got the first dose of the vaccine on 02Apr2021 and the second was received yesterday 23Apr2021 at 9am (correct dosing schedule). Reporter said she woke up this morning with red bumps to her legs and neck and they are itchy. She wanted to know if it was okay to take Benadryl. 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: 1793270
Sex: F
Age:
State: OH

Vax Date: 04/24/2021
Onset Date:
Rec V Date: 10/16/2021
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: Headache; chills; fever; nausea; This is a spontaneous report from a Pfizer-sponsored program COVAX US support via a contactable consumer reported for a patient (reporter's granddaughter). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on 24Apr2021 (age at vaccination was unknown) as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced headache, chills, fever and nausea after the first dose of the COVID vaccine. The reporter was wondering what the patient could take to treat the symptoms. The outcome of the events was unknown. No follow up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1793271
Sex: F
Age:
State: SC

Vax Date: 03/11/2021
Onset Date:
Rec V Date: 10/16/2021
Hospital:

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

Lab Data: Test Name: PCR test; Result Unstructured Data: Test Result:didn't develop any antibodies

Allergies:

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

Symptoms: Allergic reaction; Migraine; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EN6207; Expiration Date: Jul2021), via an unspecified route of administration on 11Mar2021 as dose 1, single for COVID-19 immunization. Medical history included mild case of covid infection (prior to first shot) and did not develop any antibodies as per a PCR test done 2 and 3 weeks after infection. The patient stated that she was at high risk for covid infections. Concomitant medications were not reported. On an unspecified date in 2021, the patient experienced allergic reaction, migraine for 14 days. On an unspecified date, the patient underwent lab tests and procedures which included polymerase chain reaction: did not develop any antibodies. The outcome of events unknown. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1793272
Sex: F
Age:
State: CA

Vax Date: 04/22/2021
Onset Date: 04/23/2021
Rec V Date: 10/16/2021
Hospital:

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

Lab Data: Test Date: 20210423; Test Name: body temperature; Result Unstructured Data: Test Result:103.3 Fahrenheit

Allergies:

Symptom List: Vomiting

Symptoms: fever; redness; skin warm; Her skin continues to be warm and itching; purple blotch on her skin; She reports the hives are worse, they are spreading more and she thinks more are coming out.; rash like hives on her thighs, her arms and all over her body; rash is very thick and tight and it's giving her pain; cough; swollen lymph nodes; very bad headache; her temp was 101.8 with a slight headache. A few hours later her temp was 103.3 with a very bad headache; armpit started to swell; felt like she couldn't eat; felt like she would throw up; This is a spontaneous report from a contactable consumer or other non hcp. A 54-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: Batch/Lot Number: EW0170; Expiration Date: 31Aug2021), via an unspecified route of administration, administered in Arm Left on 22Apr2021 (at the age of 54-years-old) as dose 2, single for COVID-19 immunisation. Medical history included blood pressure measurement from an unknown date and unknown if ongoing. Concomitant medication(s) included atorvastatin (ATORVASTATIN) and losartan (LOSARTAN) taken for an unspecified indication from an unspecified start date and ongoing. The patient previously took aspirin [acetylsalicylic acid] and experienced drug hypersensitivity. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: Batch/Lot Number: ER8737), via unspecified route of administration, administered in Arm Left on 01Apr2021 as dose 1, single for COVID-19 immunisation. It was reported that patient received her second Pfizer COVID 19 Vaccine on 22April2021. Patient experienced fever, redness, skin warm, her skin continues to be warm and itching on an unspecified date, swollen lymph nodes, very bad headache, her temp was 101.8 with a slight headache. A few hours later her temp was 103.3 with a very bad headache, armpit started to swell, cough, felt like she couldn't eat, felt like she would throw up on 23Apr2021, rash is very thick and tight and it's giving her pain on 24Apr2021 rash like hives on her thighs, her arms and all over her body, purple blotch on her skin, She reports the hives are worse, they are spreading more and she thinks more are coming out. on 25Apr2021. She experienced a fever, swollen lymph nodes under her arm and a very bad headache. On Friday 23April2021 her temp was 101.8 with a slight headache. A few hours later her temp was 103.3 with a very bad headache. Her armpit started to swell on Friday 23April2021. On Sunday 25April2021 she developed a rash on her thighs that has spread at this time. The rash started as redness on her thighs with different size dots. The following day it was all together. There is a small area where no redness is present that has turned purple. She described the purple area as "looks like a bruise". She took Zyrtec the first night. It kind of helped with the itching. On Monday night 26April2021 she took Benadryl per her pharmacy recommendation, no relieve. Her skin continues to be warm & itching.`She can't sleep much during the night. Patient wants to know if the purple spot on her leg may be a blood clot and if so when should she seek for medical help. On Sunday, 25Apr2021, maybe at around 4:00PM-5:00PM she started to develop a rash like hives on her thighs and both her arms and then all over body. It looks like hives. Since then she's taken Zyrtec and tried Benadryl. The hives continue to spread and the hives are really painful. She called her doctor around 3:00AM in morning, 27Apr2021 because her hives were very itchy. On her thigh there is some kind of purple blotch on her skin. She was afraid that she had a blood clot. She sent pictures to the doctor and the doctor saw how bad the hives were and prescribed her Prednisone. Patient asking that if she can take the Prednisone that had been prescribed. She is calling to see if taking the Prednisone is going to void out her COVID 19 vaccine or interrupt the effectiveness of the vaccine. She reports she panicked early in the morning around 2:30AM because she noticed the purple blotches. She has more on her thigh. She reports the hives are worse, they are spreading more and she thinks more are coming out. The rash is very thick and tight and it's giving her pain. The Zyrtec and the Benadryl aren't helping at all. Well maybe the Zyrtec is helping a little bit with the itching. She does report she exercises regularly. She wants to point out that when she had the COVID 19 vaccine, within 24 hours she had a fever of 103.3 and her headache was terrible. She had a really bad headache. She took Tylenol probably at the 26th hour after she received her COVID 19 vaccine. She received her vaccine at 2:00PM and she took the Tylenol the following day at around 3:15PM because she couldn't stand the pain of her headache anymore. Her armpit was swollen and then maybe because of the fever she felt like she couldn't eat, she felt like she would throw up. She did not vomit. When she took the Tylenol, a couple hours after, her headache was better and the fever had gone down to 102 degrees Fahrenheit. She would say that she felt good, she felt better on Sunday morning, 25Apr2021. She still gets a headache if she coughs. But then in the afternoon on Sunday 25Apr2021 is when the hives came. She reports the swollen area under her arm was better on Sunday, 25Apr2021. Is no longer swollen. She did feel a little pain under her arm but she does not feel that anymore. She can tell it is better because she can put her arm down by her side and not feel the lump anymore. The patient underwent lab tests and procedures which included body temperature: 103.3 fahrenheit on 23Apr2021. Outcome of the events swollen lymph nodes, her temp was 101.8 with a slight headache. A few hours later her temp was 103.3 , felt like she could not eat and felt like she would throw up was recovered on 25Apr2021, outcome of rash like hives on her thighs, her arms and all over her body, rash is very thick and tight and it's giving her pain and Hives was not recovered and outcome of very bad headache, armpit started to swell, redness, Her skin continues to be warm and itching, purple blotch on her skin and cough was Unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained

Other Meds: ATORVASTATIN; LOSARTAN.

Current Illness:

ID: 1793273
Sex: M
Age:
State:

Vax Date: 04/02/2021
Onset Date:
Rec V Date: 10/16/2021
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: headache; fever; chills; very unusual markings on legs; This is a spontaneous report from non-contactable consumer (patient himself) via Pfizer sponsored program. A male patient of an unspecified age received first dose of BNT162B2(PFIZER-BIONTECH mRNA COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 02Apr2021 (Batch/Lot number was not reported) as Dose 1, Single for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. After vaccine, the patient had experienced normal side effects such as headache, fever and chills. But the last week or so he had very unusual markings on legs. Lines on legs go up and down and they come and go. Never took any medication. Even HCP doesn't knew where marks came from but suggested covid vaccine. The outcome of the events was unknown. No follow-up attempts are possible; Information related to batch/Lot number could not be requested.

Other Meds:

Current Illness:

ID: 1793274
Sex: F
Age:
State: MO

Vax Date: 03/05/2021
Onset Date:
Rec V Date: 10/16/2021
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: Arm sore; This is a spontaneous report received from a contactable consumer or other non hcp. A 64-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: EN6203) via an unspecified route of administration in Arm Left on 05Mar2021 (age at vaccination 64years old) as single dose for covid-19 immunisation. Medical history included diabetes mellitus from an unknown date and unknown if ongoing Taking metformin maintain normal range, obesity from an unknown date and unknown if ongoing 300 lbs, hypertension from an unknown date and unknown if ongoing maintain normal range with mild medication, arthritis from an unknown date and unknown if ongoing take anti-inflammatory drugs, pain medication as needed. The patient had a historical vaccine of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: EM9809) via an unspecified route of administration in Arm Left on 05Mar2021 14:00 (age at vaccination 64years old) as single dose for covid-19 immunisation. Concomitant medication(s) included paracetamol (TYLENOL); diphenhydramine hydrochloride (BENADRYL) all taken for an unspecified indication, start and stop date were not reported. The patient experienced arm sore on an unspecified date. The clinical outcome of the event was unknown. Therapeutic measures were taken as a result of arm sore. No follow-up attempts are needed. Information about lot/batch number cannot be obtained.

Other Meds: TYLENOL; BENADRYL

Current Illness:

ID: 1793275
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/16/2021
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:

Allergies:

Symptom List: Injection site swelling, Limb discomfort

Symptoms: she bled at injection site after administration and some vaccine; she bled at injection site after administration and some vaccine; This is a spontaneous report from a Pfizer sponsored program support. A contactable health care professional reported for the patient. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient had bled at injection site after administration and some vaccine might have come out. 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: 1793276
Sex: F
Age:
State:

Vax Date: 04/06/2021
Onset Date:
Rec V Date: 10/16/2021
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: sinisistus; low grade fever; cough; body aches; chills; This is a spontaneous report from a non-contactable consumer (patient) via a Pfizer sponsored program. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number and Expiry date: not reported), via an unspecified route of administration on 06Apr2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced sinisistus, low grade fever, cough, body aches and chills. Patient and her husband were due for second dose of bnt162b2 vaccine Thursday, she had two questions, what was the reason for the time laps in reactions (14-15 days) and should they get the second dose. 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: 1793277
Sex: F
Age:
State:

Vax Date: 04/20/2021
Onset Date: 04/20/2021
Rec V Date: 10/16/2021
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: Arm swelling; Unable to stand without falling; Unable to stand without falling; Very dizzy; Severe fatigue; Migraine/sledgehammer feeling in my head and temp; Migraine/sledgehammer feeling in my head and temp; Chills; High fever; Vomited; Chest palpitations; A 43-years-old non pregnant female patient received second dose of bnt162b2 (Solution injection; Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 20Apr2021 (at the age of 43-years-old) as single dose for covid-19 immunisation. Medical history was none. Patient had no known allergies. The patient concomitant medications were not reported. Patient previously received first dose of bnt162b2 (Solution injection; Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 30Mar2021 as single dose for covid-19 immunisation. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 20Apr2021, 7 hours after the vaccination, patient experienced arm swelling, unable to stand without falling, very dizzy, severe fatigue, migraine/sledgehammer feeling in my head and temp, chills, high fever, vomited 4 times and chest palpitations. Patent reported that she started recommended medication and will seek medical care. The outcome of all the events was not recovered. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am