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: 1646659
Sex: F
Age:
State: NC

Vax Date: 07/30/2021
Onset Date: 07/31/2021
Rec V Date: 08/28/2021
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: Seemed to reactivate my polymyalgia rheumatica autoimmune; Seemed to reactivate my polymyalgia rheumatica autoimmune; Muscle pain; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: FC3180), via an unspecified route of administration, administered in right arm on 30Jul2021 18:30 (at 65 years old) as dose 1, single for COVID-19 immunization. Medical history included polymyalgia rheumatica, and allergies to fluorquinolone family of antibiotics. 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. There were no concomitant medications. The patient previously took erythromycin, sulfamethoxazole, and levofloxacin and experienced drug allergy. On 31Jul2021, the patient reported muscle pain and reported that the vaccine seemed to reactivate her polymyalgia rheumatica autoimmune. There were no treatments received for the events. The outcome of the events was not recovered. Follow-up attempts are completed, No further information is expected.

Other Meds:

Current Illness:

ID: 1646660
Sex: F
Age:
State: TX

Vax Date: 08/05/2021
Onset Date: 08/05/2021
Rec V Date: 08/28/2021
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: Having really heavy menstral bleeding; Am not due for a period until the end of the month i had ended my last cycle on 28Jul; This is a spontaneous report from a contactable consumer or other non-HCP (patient herself). A 29-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: FA7485), dose 1 via an unspecified route of administration, administered in the right arm on 05Aug2021 18:30 (at the age of 29-years-old) as dose 1, single for COVID-19 immunisation. The patient's medical history included known allergies to Latex. The patient's concomitant medications received within 2 weeks of vaccination included diclofenac sodium (SPRINTEX) taken birth control. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had no Covid prior to vaccination. The patient was not tested post vaccination. On 05Aug2021, the patient was vaccinated at 6:30 pm and at 7:30 (19:30) pm started having really heavy menstrual bleeding she was not due for a period until the end of the month she had ended her last cycle on 28Jul2021, and her cycles were never this heavy. The adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient not received treatment for the events. The outcome of the events was not recovered.

Other Meds: SPRINTEX

Current Illness:

ID: 1646661
Sex: M
Age:
State: IL

Vax Date: 04/12/2021
Onset Date: 04/01/2021
Rec V Date: 08/28/2021
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 Date: 2021; Test Name: magnesium; Result Unstructured Data: Test Result:Low; Test Date: 20210412; Test Name: Blood pressure; Result Unstructured Data: Test Result:High; Test Date: 20210412; Test Name: Blood pressure; Result Unstructured Data: Test Result:Low; Test Date: 202102; Test Name: Blood work; Result Unstructured Data: Test Result:Normal; Test Date: 2021; Test Name: Blood work; Result Unstructured Data: Test Result:Unknown result; Test Date: 2021; Test Name: Blood work; Result Unstructured Data: Test Result:abnormal; Test Date: 2021; Test Name: stress test; Result Unstructured Data: Test Result:Fine; Test Date: 2021; Test Name: C reactive protein; Result Unstructured Data: Test Result:fine and low; Test Date: 2021; Test Name: EKG; Result Unstructured Data: Test Result:Abnormal and read possible inferior infarct; Test Date: 2021; Test Name: EKG; Result Unstructured Data: Test Result:S and T wave abnormality and tachycardia; Test Date: 2021; Test Name: d dimer; Result Unstructured Data: Test Result:fine and low; Test Date: 2021; Test Name: Heart rate; Result Unstructured Data: Test Result:above 120 while he was laying down; Test Date: 2021; Test Name: Heart rate; Result Unstructured Data: Test Result:48-140 bpm; Test Date: 2021; Test Name: Heart rate; Result Unstructured Data: Test Result:Elevated; Test Date: 2021; Test Name: Heart rate; Result Unstructured Data: Test Result:150 beats per minute; Test Date: 2021; Test Name: neutrophils absolute; Result Unstructured Data: Test Result:high; Test Date: 2021; Test Name: troponin; Result Unstructured Data: Test Result:fine and low; Test Date: 202102; Test Name: white blood cell count; Result Unstructured Data: Test Result:Normal; Test Date: 2021; Test Name: white blood cell count; Result Unstructured Data: Test Result:High

Allergies:

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

Symptoms: left arm felt cold, temperature of his arm was cold; head felt like he was coming off Novocain, like at the very end of coming off of novocain/ face felt numb, like when you sleep on your arm and cut the circulation off but his head felt like that; felt like his right hand was going asleep/at night he would feel both his legs go to sleep; Pins and needles; He had high blood pressure; he would feel both his legs go to sleep, like as if his heart was not working as hard; Felt like he had low blood pressure; face felt numb/legs went completely numb; possibly got up too fast and almost felt like he was going to pass out; probably anxiety; feel chest pain; hyperventilated; he could not move anything and everything was clenching up; hands clenched and he could not move anything and everything was clenching up; magnesium was low; high white blood cell count; high neutrophils absolute; heart beat would go from 48bpm; Panic attacks; it looked like he had a heart attack before in his lower heart/possible inferior infarct; Tachycardia/resting heart rate was elevated; His head was clenching up and felt like he was going to die; This is a spontaneous report from a contactable consumer (patient). A 34-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 12Apr2021 (Batch/Lot Number: ER8735) (at the age of 34 years) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included feeling abnormal (cut the circulation off but his head felt like that, felt like this once before when he had a wisdom tooth in the past). There were no concomitant medications. The patient previously took vicodin. Patient received his first dose of the Pfizer COVID-19 vaccine on 12Apr2021 and has not received the second dose yet, stated that there was a delay because he had issues after the first shot. He had issues after his first shot and he is recovered now. He had been to the ER three times after the vaccine. He was never admitted. The doctor said it might be anxiety. He is asking if he can the got second shot and be fully vaccinated since it has been about 4 months since his first dose. On the day of the vaccine, he never got a chance to sit down. He got the shot and was wandering around. First thing was that his left arm felt cold, temperature of his arm was cold. Within 20 minutes his head felt like he was coming off Novocain, not severe Novocain, like at the very end of coming off of novocain is what it felt like. He asked if it was normal and was worried. He then went home and he felt like his right hand was going asleep, it was like a pins and needles feeling which scared him. He went to ER on 12Apr2021. He had high blood pressure and he did not know at the time. The ER did not do any more tests and they sent him home and said the vaccine was safe and was told it was probably anxiety. At night he would feel both his legs go to sleep, like as if his heart was not working as hard. Felt like he had low blood pressure even though he could not check it. He remembers waking up where his face felt numb, like when you sleep on your arm and cut the circulation off but his head felt like that. He may have felt like this once before when he had a wisdom tooth in the past and had Vicodin and possibly got up too fast and almost felt like he was going to pass out. He thought to remedy it since he thought it was a blood circulation issue to wear tight socks and keep his legs lifted up to help with blood circulation, he did this for three nights. He did not go to the doctor at this time since he felt like he was fine. After those three nights, those blood circulation and pins and needles symptoms went away. Then he started to feel chest pain 3 or 4 days after the vaccine. He never really goes to the doctor and was able to get an appointment at a cardiologist and he did a ton of bloodwork. He did blood work in Feb2021 prior to the vaccine and it was all normal. The cardiologist did an ekg that was abnormal and read possible inferior infarct. Cardiologist asked him if he had ever had a heart attack since it looked like he had a heart attack before in his lower heart. Next thing that day was another test where he ran on treadmill, it was a stress test and this test came out fine. The cardiologist said the ekg was probably just positioning since the stress test was fine. C reactive protein, d dimer, and troponin was drawn and it was all fine and low. Next ER visit happened the week that he was supposed to get second shot which he thought may have been anxiety. He noticed his resting heart rate was elevated since the shot. He started wearing a band that was monitoring his heart beat. Felt like he had adrenaline dumps and his heart rate would go up on occasion. He had one of these episodes, one of the days he was working from home and his resting heart rate was 150 beats per min. He felt chest pain and heart beat was high and it was scary. This made him go an immediate care place around 11am, not the hospital. Another ekg which was abnormal and showed S and T wave abnormality and tachycardia. He had elevated heartrate for a long period of time. He was supposed to go to his PCP but he rushed to ER instead. He was diagnosed at the ER as a panic attack. He hyperventilated, his legs went completely numb and hands clenched and he could not move anything and everything was clenching up. His head was clenching up and felt like he was going to die. The ER gave him an anti-anxiety pill that was called lorazepam and he did feel the symptoms subside. He did breathing exercises as well. He felt better and they did a bunch of blood tests. The findings that were abnormal was his magnesium was low, high white blood cell count, and high neutrophils absolute, which is a type of white blood cell he thinks. He was prescribed lorazepam. And was told that an anti-depressant would help but it made him worse and he stopped taking it. He continued for a little bit having these panic attacks where his hands would clench up and the lorazepam would get him out of it. While he was driving, his hands would clench up and have panic attacks while driving. The third time he went to ER was in mid Jun2021 because he had symptoms of a panic attack; his heart beat was very high. He took lorazepam which should calm his mind and heart rate, but his heart rate stayed elevated, heart rate stayed above 120 while he was laying down. They did more blood and heart tests. Ekg was normal rhythm but showed tachycardia. He did a Holter monitor prior to this and only finding was often times of tachycardia, that his range of heart beat would go from 48bpm to 140bpm, all times of the day which concerned him since he thought anxiety would cause this when awake but his heart beat would be elevated even when he was sleeping. Blood test showed his white blood cells and absolute neutrophils were still high but came down. D dimer and troponin was low so there was no heart damage or blood clots. He had an appointment with his regular doctor and was prescribed propranolol, which is a beta blocker, to lower his heart rate. Since the beta blocker, reports it has worked and he has only had to take it once. He has a baseline lab tests with quest diagnostics and his white blood count was normal in Feb2021. A lot of the things that were elevated after the shot were normal back in Feb2021 prior to the vaccine. He has the labs if needed. He was never admitted to the hospital. He does not have the antidepressant to provide details because he only took two and discarded it. Now he is 100% fine. The outcome of events was recovered. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1646662
Sex: F
Age:
State:

Vax Date: 07/30/2021
Onset Date: 07/31/2021
Rec V Date: 08/28/2021
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: she felt her heart was squeezed really tight and had a similar feeling with anxiety attack; This is a spontaneous report from a contactable consumer. This 48-year-old female consumer reported for herself that. A 48-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 30Jul2021 as (At the age of 48-years) DOSE 1, SINGLE for covid-19 immunisation. Medical history included anxiety from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient experienced she felt her heart was squeezed really tight and had a similar feeling with anxiety attack. It was reported that Caller had the 1st dose of the Pfizer COVID 19 vaccine on 30Jul2021 the day after, she felt her heart was squeezed really tight and had a similar feeling with anxiety attack Asking if this is a reported side effects of the vaccine - She has been experiencing the symptoms until now. The outcome of evets was not recovered. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1646663
Sex: F
Age:
State: MD

Vax Date: 02/11/2021
Onset Date: 02/01/2021
Rec V Date: 08/28/2021
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: 20210215; Test Name: mammogram; Result Unstructured Data: Test Result:Unknown results; Test Date: 2021; Test Name: ultrasound; Result Unstructured Data: Test Result:Unknown results

Allergies:

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

Symptoms: enlarged lymph nodes/swollen lymphnodes; Pain especially under right side of my breast; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 11Feb2021 (lot number: EN9581) as dose 1, single and via an unspecified route of administration on 03Mar2021 (lot number: EN6205) as dose 2, single for COVID-19 immunization. Medical history included overweight from an unknown date and unknown if ongoing. Concomitant medications included vitamins NOS taken for an unspecified indication, start and stop date were not reported. The patient experienced enlarged lymph nodes/swollen lymphnodes on an unspecified date in Feb2021 and pain especially under right side of my breast on an unspecified date in 2021. It was reported that the patient developed swollen lymphnodes after the first dose. They continue to be swollen. She had an emerge lymph node and they said it was probably due to Pfizer. She had her second shot on 03Mar2021. They thought it was reaction of it because of the vaccine. Ever since then they had to call her every 8 week or every 6 weeks, the lymph nodes were still enlarged so she just need to see how during trial she should expect them to be enlarged. The exact date, she had to look it up it and said it was couple days after she got her first shot, she went for her mammogram she had to look that again and said it was probably around 15Feb roughly but she does not have the exact date. The patient added that she thought it got worse to be honest. She still has pain especially under right side of her breast. The patient underwent lab tests and procedures which included mammogram: unknown results on 15Feb2021 and ultrasound scan: unknown results on 2021. The outcome of the events was not recovered. Follow-up attempts are completed. No further information is expected.

Other Meds: VITAMINS NOS

Current Illness:

ID: 1646664
Sex: F
Age:
State: HI

Vax Date: 02/24/2021
Onset Date: 02/24/2021
Rec V Date: 08/28/2021
Hospital: Y

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: Test Date: 20210224; Test Name: tachycardia; Result Unstructured Data: Test Result:increase; Comments: 01:30 AM

Allergies:

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

Symptoms: tachycardia, swelling of throat, sever muscle and joint pain, Lingering short term memory problems that affect daily life; tachycardia, swelling of throat, sever muscle and joint pain, Lingering short term memory problems that affect daily life; tachycardia, swelling of throat, sever muscle and joint pain, Lingering short term memory problems that affect daily life; tachycardia, swelling of throat, sever muscle and joint pain, Lingering short term memory problems that affect daily life; tachycardia, swelling of throat, sever muscle and joint pain, Lingering short term memory problems that affect daily life; This is a spontaneous report from a contactable HCP (patient). A 34-year-old female patient (not pregnant) received the second dose of BNT162B2 via an unspecified route of administration on left arm on 24Feb2021 at 01:00 PM (Lot Number: EL9263) at the age of 34-year-old as single dose for COVID-19 immunization. Medical history included asthma. Known allergies included erythromycin, shellfish and flu vaccine. No other vaccine in four weeks. COVID prior vaccination was none. COVID tested post vaccination was none. Concomitant medication included cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]). The patient previously received flu vaccine, the erythromycin and experienced erythromycin allergies. The patient previously received the first dose of BNT162B2 via an unspecified route of administration on left arm on 03Feb2021 at 02:00 PM (Lot Number: EL8982) at the age of 34-year-old as single dose for COVID-19 immunization. On 24Feb2021 at 01:30 AM, the patient experienced tachycardia, swelling of throat, sever muscle and joint pain, Lingering short term memory problems that affect daily life. The events resulted in emergency room/department or urgent care. Treatment was received for events included epi, Benadryl, steroids and cardiac monitoring. The outcome of events was resolved with sequel.; Sender's Comments: Based on available information and the drug temporal relationship, the causality between the events memory impairment, tachycardia, pharyngeal swelling, myalgia, arthralgia and the suspect drug "BNT162B2" annot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Other Meds: ZYRTEC [CETIRIZINE HYDROCHLORIDE]

Current Illness:

ID: 1646665
Sex: F
Age:
State: GA

Vax Date: 05/01/2021
Onset Date: 06/01/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Pyrexia, White blood cell count decreased

Symptoms: arm is still sore/would hurt/it is worse now with the hurting; arm is still sore, at first it was just red and swollen a bit; arm is still sore, at first it was just red and swollen a bit; brain tumor; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program Pfizer RxPathways. A female patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot number was not reported) via an unspecified route of administration on May2021 as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Historical vaccine includes first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot number was not reported) on Apr2021 for COVID-19 immunization. On an unspecified date, patient experienced arm is still sore, at first it was just red and swollen a bit, but would hurt and it is worse now with the hurting. On Jun2021 patient had brain tumor and would be undergoing surgery. Outcome of event "arm is still sore/would hurt/it is worse now with the hurting" was not recovered while outcome of all other events was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1646666
Sex: F
Age:
State: CA

Vax Date: 08/03/2021
Onset Date: 08/03/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data: Test Name: oxygen level; Result Unstructured Data: Test Result:95-97

Allergies:

Symptom List: Pharyngeal swelling

Symptoms: feet swelled up a little bit; Elephantitis; Having trouble breathing/short of breath, she couldn't take a deep breath; allergic reaction; legs were itching; weird-looking rash, very bumpy and red; bubbly and itching; weird-looking rash, very bumpy and red; bubbly and itching; weird-looking rash, very bumpy and red; bubbly and itching; This is a spontaneous report from a contactable nurse (patient). A 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), at same age, dose 2 intramuscular, administered in Deltoid Left on 03Aug2021 (Batch/Lot Number: EW0177) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0177), at age of 63 years old, on Left deltoid for covid-19 immunisation on 13Jul2021. Reported an "allergic reaction" after receiving the Pfizer-BioNTech COVID-19 Vaccine, patient developed a "bumpy and bubbly rash". Patient clarified she had an allergic reaction. As soon as she got the shot. She got the shot at 14:30-15:30, and within 2 hours, by 16:00, she was having trouble breathing. She was short of breath, she couldn't take a deep breath. Her legs were itching. She had a weird looking rash- it's very bumpy and red. It looks like Elephantitis. She explains further it's a weird rash, it's not hives, it's a different kind of rash. She knew what hives was and it's not hives. The rash was bumpy and looks bubbly, she still had the rash. The rash was very itch and she still had scars from it. She mentioned her feet swelled up a little bit. When probed for the seriousness criteria of her reaction, the patient stated it could be life-threatening if you can't breathe. Her reaction began after her second dose. She received her second dose on 03Aug2021. The lot number is the same for both her first and second dose. She explains the amount of the dose was not on her vaccine record card. She felt the reaction was definitely caused from the vaccine. She stated there were no blood tests for this reaction. Her CO2, clarified as her oxygen level was between 95 and 97, which was okay. None of vaccines administered on same date of the Pfizer suspect. Patient went to emergency room urgent care because she couldn't breathe. None of Vaccinations administered within four weeks prior to the first administration date of the suspect vaccine. Reporter seriousness for short of breath, she couldn't take a deep breath was Life threatening Reporter considered that short of breath, she couldn't take a deep breath and weird-looking rash, very bumpy and red; bubbly and itching were related. The outcomes of events having trouble breathing/short of breath, she couldn't take a deep breath, Elephantitis and feet swelled up a little bit were unknown, while other events were not recovered.; Sender's Comments: Based on the information available and close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events Elephantitis and Breathing difficult . The case will be reassessed once new information is available The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Other Meds:

Current Illness:

ID: 1646667
Sex: F
Age:
State:

Vax Date: 03/01/2021
Onset Date:
Rec V Date: 08/28/2021
Hospital:

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

Lab Data: Test Name: biopsy; Test Result: Negative ; Test Name: colonoscopy; Test Result: Negative ; Test Name: mammogram; Test Result: Negative

Allergies:

Symptom List: Abdominal pain, Chills, Sleep disorder

Symptoms: The has been feeling non-stop pain at back of her neck, head, shoulder blades, and the arm; The has been feeling non-stop pain at back of her neck, head, shoulder blades, and the arm.; The has been feeling non-stop pain at shoulder blades/joint pain; Caller had developed a painful lump on her neck.; feeling strain and pain in the arm; She said she isn't bothered by the lump but instead of the pain.; feeling strain and pain in the arm; pain in the arm where she got the 2nd shot; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 48-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot Number unspecified, expiration date unspecified), via an unspecified route of administration, administered in Arm on Mar2021 as dose 2, single for covid-19 immunization. Previously on an unknown date, the patient received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number unspecified, expiration date unspecified), via an unspecified route of administration on an unknown date as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date, the patient has been feeling non-stop pain at back of her neck, head, shoulder blades and joint pain, the patient had developed a painful lump on her neck, feeling strain and pain in the arm. Patient stated she had both shots and noticed a side effect. Reportedly, soon after the vaccine, she had a lump on her neck, and went to the doctor. Patient does not know what the lump is. The patient reported she was not bothered by the lump but instead of the pain. She also had been feeling strain and pain in the arm where she got the 2nd shot. The patient had to visit the doctor due to painful lump in the neck and non-stop pain. There the doctor advised few tests which included biopsy, colonoscopy, mammogram and all the results were negative for cancer but lump was still there. Patient has every test possible. The patient took Advil and tried warm compress to relive the pain, but it still would not go away. The patient informed that this has been affecting her day to day in general and had concern if this was a lifelong pain. Patient asked if she can be on the clinical trial mentioned -How long side effects last from the paragraph which read "The safety evaluation of participants was still ongoing. The report was not related to a study or programme. Patient declined to complete a safety report. Patient questioned do other people have this, how long do they have it, was this a short term or long term effect. Treatment was received for the events. The outcome of the events was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1646668
Sex: F
Age:
State: UT

Vax Date: 03/20/2021
Onset Date: 04/26/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data: Test Date: 20210426; Test Name: Heart rate; Result Unstructured Data: Test Result:100-135 bpm

Allergies:

Symptom List: Diarrhoea, Nasal congestion

Symptoms: Fast heart beat (100-135 bpm when sitting and not active).; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 34-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EW0162), via an unspecified route of administration, administered in the left arm on 20Mar2021 10:00 (at the age of 34-year-old) as dose 2, single for COVID-19 immunisation. The patient's medical history was not reported. Patient had no known allergies. Patient took birth control medication within 2 weeks of vaccination. Patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: ER8727), via an unspecified route of administration, administered in the left arm on 20Mar2021 10:00 (at the age of 34-year-old) as dose 1, single for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 26Apr2021, the patient experienced fast heartbeat (100-135 bpm when sitting and not active). Patient Had not gone to doctor but was thinking of going. The patient underwent lab tests and procedures which included heart rate increased: 100-135 bpm on 26Apr2021. No treatment received as a result of events. The reporter considered the event as non-serious. The outcome of the event was not recovered.

Other Meds:

Current Illness:

ID: 1646669
Sex: M
Age:
State:

Vax Date: 03/24/2021
Onset Date:
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: having unusual feelings and situations in his life; He has been a little unsteady when walking; needs assistance standing for more than a minute; constipation; speech trouble.; states that it is getting worse.; Dizziness; This is a spontaneous report from a contactable consumer or other non hcp. A male patient of an 61 years age received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported expiry date: unknown) via an unspecified route of administration on 24Mar2021 (at the age of 61-years-old) as a Dose 2,Single for COVID-19 immunization. The patient's medical history was not reported. The patient's concomitant medications were not reported. Patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported expiry date:Unknown) via an unspecified route of administration on an unspecified date as a Dose 1,Single for COVID-19 immunization. The patient had second shot on 24Mar2021 and was fine but had a little bit of dizziness, unsteady walking, trouble standing up and had pretty bad constipation. He had been a little unsteady when walking, needs assistance standing for more than a minute, he had to lean on something, he developed constipation and speech trouble. These began feeling this 3 months ago and can't relate this to the vaccine and stated that it was getting worse. Reporter stated that he had been having unusual feelings and situations in his life and wondering if people have had similar reactions. Outcome of the events was unknown. Information about the Lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1646670
Sex: M
Age:
State: AL

Vax Date: 05/27/2021
Onset Date: 08/06/2021
Rec V Date: 08/28/2021
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: 20210806; Test Name: Nsal Swab; Test Result: Positive ; Comments: Nasal swab

Allergies:

Symptom List: Rash, Urticaria

Symptoms: tested positive for Covid; tested positive for Covid; This is a spontaneous report from a contactable consumer (patient's parent) via COVID-19 Adverse Event Self-Reporting Solution (COVAES). A 23-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: ER8735) via intramuscular route, administered in Left Arm on 05May2021(23-year-old at vaccination) as Dose 1, single and via intramuscular route, and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: EW0171), administered in Left Arm on 27May2021, (23-year-old at vaccination) as Dose 2, single, both doses for Covid-19 immunization. The patient's medical history was reported as none. The patient had no known allergies. The patient's concomitant medications were not reported. Facility where the most recent COVID-19 vaccine was administered was reported as Other. 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 had been tested for COVID-19. On 06Aug2021 at 10:00 AM, the reporter stated that, the patient had experienced a loss of smell today after attending a wedding this past weekend and tested positive for Covid this afternoon. The adverse event resulted in Doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included SARS-CoV-2 test (Nasal swab): positive on 06Aug2021. No treatment received from the resulted events. The outcome of the events was not recovered. Follow-up attempts completed. No further information expected.

Other Meds:

Current Illness:

ID: 1646671
Sex: F
Age:
State: CA

Vax Date: 02/01/2021
Onset Date:
Rec V Date: 08/28/2021
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: lung problem; This is a spontaneous report from a contactable consumer (patient) from a Pfizer sponsored program COVAX US Support. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on Feb2021 as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient historical vaccine included first 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 Feb2021 as single for COVID-19 immunisation. The patient experienced lung problem on an unspecified date. Reported as, "she already received her first and second of the Pfizer Covid-19 vaccine in February. Caller mentioned that she's been hearing news that Pfizer is providing a third dose or a booster shot and she wants to know if it's true. Also would like to know if it is necessary for her to get the third dose because she'll be going on a cruise in September and she also mentioned that she has a little bit of a lung problem. Outcome of the event was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1646672
Sex: F
Age:
State: CA

Vax Date: 08/05/2021
Onset Date: 08/05/2021
Rec V Date: 08/28/2021
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: The next day got a bit of a rash on arms.; Right away got like a sour metal kind of taste in mouth; This is a spontaneous report from a contactable other healthcare professional, the patient. A 42-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3180) via an unspecified route of administration in the left arm on 05Aug2021 at 09:00 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Other medical history not reported. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 05Aug2021 at 09:45, the patient right away experienced like a sour metal kind of taste in mouth. On 06Aug2021, the patient experienced a bit of a rash on the arms. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events sour metal kind of taste in mouth and a bit of a rash on the arms was not recovered at the time of this report.

Other Meds:

Current Illness:

ID: 1646673
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/28/2021
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: Heart rate decreased, Heart rate increased, Hypertension, Injection site pain, Musculoskeletal chest pain

Symptoms: On her arms, from mid forearm to fingertips had kind of neuropathy feeling; the right side of her face had tingling nerve/feet up to mid-calf had tingling; entire chest felt like it was on fire, which went up the neck; entire chest felt like it was on fire, which went up the neck/aching in the neck; Later added that it was more than esophageal, digestive burning; sore arm; legs felt wobbly like they could give out from under her, but they didn't.; digestive burning; trigeminal nerve thing; Ocular migraine; vision gets flashing lights; This is a spontaneous report from a non-contactable other hcp (patient herself). A 61-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included allergies to medicines like CT dyes, but it's always been tightness in the chest, a little shortness of breath. The patient's concomitant medications were not reported. Reports that she had an odd reaction to her first vaccine. Her entire chest felt like it was on fire, which went up the neck. A lot of allergies to medicines like CT dyes, but it's always been tightness in the chest, a little shortness of breath. This was different. Describes it as you could draw a circle on her chest. the whole chest felt like it was on fire. Later added that it was more than esophageal, digestive burning. Started about 5 hours after vaccine administered. She wants to know if there are other people with that, and if so, should she get the second dose. Says symptoms persisted for about 72 hours after, had aching in the neck, the original burning in cavity of chest quit, but still had one spot on the right side of chest and neck. 10:15 am tuesday got shot, by saturday, like someone flipped a light switch, and everything that was going on just quit. Says she has weird things with medicine. Caller then asked about myocarditis. Knows most of those were younger boys. Do you ever get older people? And would it resolve on it's own and would it resolve on it's own without steroids? Did they take the second vaccine and were they ok? Or did they have to take medications for that? Were they all men? She says the other thing that happened is that the morning after the vaccination, her legs (no history of neuropathy) feet up to mid-calf had tingling, not burning, and legs felt wobbly like they could give out from under her, but they didn't. She was able to keep walking. On her arms, from mid forearm to fingertips had kind of neuropathy feeling. No signs of stroke. Says she doesn't want to end up with MS or a heart problem. On the day of vaccine, the right side of her face had tingling nerve, like you could draw a line from temple to nose on the cheekbone. Was tingly several times, but didn't stay. States it was almost like a trigeminal nerve thing, or like an ocular migraine, and that part of your vision gets flashing lights, and there is a little brown haze and squiggly lines. This happened on her right side (also side of injection). Did the Bells Palsy resolve itself or did it result in the paralysis of the face? What about Guillain Barre? Says it is probably too soon to know if anyone has gotten MS but wondering about GBS. What happens when you put second dose in there, more permanent, does that mean you have to have a history of GBS? Or can you get GBS from the vaccine? Due for 2nd dose 17AUG. How much protection does she have with one dose and should she get the second dose. The outcome of the events was recovered on an unspecified date in 2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the event Peripheral neuropathy and suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Other Meds:

Current Illness:

ID: 1646674
Sex: F
Age:
State: WI

Vax Date: 08/05/2021
Onset Date: 08/06/2021
Rec V Date: 08/28/2021
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: Both arms and tops of hands were burning; Both arms and tops of hands appear reddened the day after vaccine; Showering the warm water felt like pins and needles; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0186) via an unspecified route of administration in the left arm on 05Aug2021 at 16:30 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history included fibromyalgia. The patient had known allergies to dust and shellfish. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not take any concomitant medications. The patient also took epinephrine (MANUFACTURER UNKNOWN) for unknown indication on an unknown date and experienced drug allergy. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 06Aug2021 at 11:00, the patient experienced both arms and tops of hands were burning and reddened the day after vaccine. When she showering the warm water felt like pins and needles on her skin. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. No therapeutic measures were taken as a result of the reported events. The clinical outcomes of events both arms and tops of hands were burning, both arms and tops of hands were reddened and showering the warm water felt like pins and needles were not resolved at the time of this report.

Other Meds:

Current Illness:

ID: 1646675
Sex: M
Age:
State: CA

Vax Date: 01/07/2021
Onset Date: 04/04/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data: Test Name: CT SCAN; Result Unstructured Data: Test Result:UNKNOWN; Comments: CT SCAN OF SINUSES; Test Name: MRI; Result Unstructured Data: Test Result:UNKNOWN

Allergies:

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

Symptoms: Headache; Hearing impaired; Dizziness; Vomiting; Brain fog for several days; Vertigo; staggered walk/crawl; This is a spontaneous report from a contactable consumer, the patient. A 68-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3302) via an unspecified route of administration on the right arm on 07Jan2021 at 15:30 as a single dose for COVID-19 immunisation. Medical history included gynecomastia and testosterone low. The patient did not have any allergies to food, medications and other products. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 04Apr2021 at 10:00 the patient experienced daily headaches and still ongoing. Intermittent hearing phenomenon - reduced, ringing, garbled, and/or amplification of low frequency sounds. Several instances of dizziness that became severe and resulted in staggered walk/crawl and vomiting, lasting several hours. Brain fog for several days after each vertigo incident. The events resulted in doctor or other healthcare professional office/clinic visit and also in emergency room/department or urgent care. Therapeutic measures were taken as a result of headache, hearing impaired, dizziness, vomiting, brain freeze and vertigo and included treatment with Meclizine. The patient underwent CT(computerized tomography) scan of sinuses, MRI(Magnetic resonance imaging), and various exams on an unknown date and the result was unknown. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events headache, hearing impaired, dizziness, vomiting, brain freeze and vertigo were not recovered at the time of this report.

Other Meds:

Current Illness:

ID: 1646676
Sex: F
Age:
State: FL

Vax Date: 03/25/2021
Onset Date: 03/01/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data: Test Name: Blood pressure; Result Unstructured Data: Test Result:120 or 124; Comments: her blood pressure is always consistent at 120 or 124; Test Date: 202103; Test Name: Blood pressure; Result Unstructured Data: Test Result:180; Comments: blood pressure was going up and stayed high at 180 something.; Test Date: 2020; Test Name: Echo; Result Unstructured Data: Test Result:unknown results; Test Date: 2021; Test Name: Echo; Result Unstructured Data: Test Result:regurgitation of the heart valve; Comments: and is mitral valve regurgitation.

Allergies:

Symptom List: Ear pain, Hypoaesthesia

Symptoms: severe allergic reactions/she developed the allergy; throat itching; tingling sensation/she felt tingling all the way up to her face; itching and the itching was going to her ears; facial swelling; rash; swelling; was feeling tingling in her throat; states her blood pressure was going up and stayed high at 180; mitral valve regurgitation; heart palpitations/Heart racing; chest tightening/chest was bothering; she couldn't breathe; Felt dizzy; felt like a panic attack; This is a spontaneous report from a contactable consumer (patient). A 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in right arm on 25Mar2021 (Batch/Lot number was not reported) (at the age of 44-years-old) as dose 1, single for COVID-19 immunisation. Medical history included ongoing immunocompromised, non-Hodgkin's lymphoma (chemotherapy for non-Hodgkin's lymphoma prior to the Pfizer COVID Vaccine), had allergies before/she had a mild allergy. There were no concomitant medications. Patient had the 1st dose of the Pfizer COVID 19 vaccine last 25Mar2021 and never received the 2nd dose due to severe allergic reactions. Patient's doctor advised her not to get the 2nd dose. She had throat itching and tingling sensation, facial swelling, heart palpitations, and rash. This week (in 2021) she was diagnosed with mitral valve regurgitation. Patient had a severe allergic reaction and ended up in the emergency room and went to see her cardiologist because she was feeling palpitations and this happened after the vaccine. Patient stated they did an echo in the emergency room. She was not admitted to the hospital for an overnight stay. At minute 29 after receiving the vaccine, by the time she walked to the car 28-29 minutes later, she developed the allergy and it began with her throat itching and she had allergies before and went to the nurse to tell her and said she had a mild allergy and was feeling tingling in her throat and they gave her Benadryl. Then 15 minutes passed, and she was not better and was itching. The itching was going to her ears and she felt tingling all the way up to her face and they gave her another Benadryl and she said she felt fine other than a mild allergy and asked to call her sister to come pick her up because she had had two Benadryl and would fall asleep. Patient stated she was facing down and looked up and the nurse said her face was swelling and to go to the emergency room for observation and was put on a stretcher and she said she felt fine. They took her to the emergency room and the allergy started progressing super-fast and started the same tingling in her throat and felt that through her entire body, had a rash, swelling and thought she was going to die. About two weeks afterwards the allergy kicked her butt so badly that afterward she could not catch her breath to walk and was not wanting to go back to her HCP and did not want to walk and her chest was bothering her and breathing was bothering her for a while. In 2021, the palpitations began and she was feeling them while she was there and her chest tightening and her heart racing and felt like she couldn't breathe and thought she was going to die and kept telling her HCP that she had allergies before her entire life but never experienced this and felt it in her chest. In Mar2021, her blood pressure was going up and stayed high at 180 something and her blood pressure is always consistent at 120 or 124 and she had never seen the numbers like that until she got the Pfizer COVID vaccine; states she does not still have chest tightness. Her high blood pressure stayed for about two weeks and she did not know that but went to her immunologist and the machine was broken and she had not seen her other HCP at the hospital but kept checking her blood pressure and it stayed high. The palpitations she had after the Pfizer Covid vaccine and she saw her primary care physician about maybe 3 weeks ago again and felt dizzy and had to pull over the interstate and it was just a weird feeling and she requested to see the cardiologist. She had her port for her chemo removed and while she was doing the intake for that they asked her about her vaccine status before she went in for port removal and she did not know what happened but had what felt like a panic attack and her HCP and anesthesiologist said she just kind of relieved that moment and she was not vaccinated at that time. She went to see her HCP and was really nervous about taking the Pfizer COVID vaccine and the palpitations are still ongoing and she felt it at night. States she wore a heart monitor for about a week and they did the echo last week and her cardiologist told her yesterday it was regurgitation of the heart valve and is mitral valve regurgitation. She called her oncologist this morning to ask for information on her echo from last year (2020) to see if the results of her recent echo were new or not new and needed the baseline to see what happened and they said she did not have that before on her previous echo. Outcome of itching, facial swelling was recovered on 25Mar2021, chest tightening and panic attack was recovered in 2021, mitral valve regurgitation was unknown while rest of events was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness: Immunocompromised (she is immunocompromised)

ID: 1646677
Sex: F
Age:
State: IN

Vax Date:
Onset Date: 05/01/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Abdominal pain upper, Dizziness, Dysgeusia

Symptoms: Diagnosed with nummular eczema; This is a spontaneous report from a contactable consumer, the patient. A 67-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6200) via an unspecified route of administration in the left arm on an unknown date in 2021 as a single dose for COVID-19 immunisation. The patient had history of known allergies to sulfa. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included omeprazole (MANUFACTURER UNKNOWN), cetirizine hydrochloride (ZYRTEC) and multivitamin from an unknown date for unknown indication and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6201) via an unspecified route of administration in the left arm on 09Feb2021 at 18:45 (at the age of 67-years-old) as a single dose for COVID-19 immunisation. The patient also took erythromycin (MANUFACTURER UNKNOWN), tetracycline (MANUFACTURER UNKNOWN) and doxorubicin (ADRIAMYCIN) for unknown indication on an unknown date and experienced drug allergy. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 01May2021, the patient had been diagnosed with nummular eczema about six weeks after the vaccination. She never had eczema before. Since the vaccination, the patient had not been tested for COVID-19. The adverse event resulted in doctor or other healthcare professional office or clinic visit. Therapeutic measures were taken as a result of reported events which included treatment with topical steroid cream (MANUFACTURER UNKNOWN). The clinical outcome of the event nummular eczema was not recovered at the time of this report.

Other Meds: OMEPRAZOLE; ZYRTEC [CETIRIZINE HYDROCHLORIDE]

Current Illness:

ID: 1646678
Sex: M
Age:
State: MD

Vax Date: 05/06/2021
Onset Date: 05/06/2021
Rec V Date: 08/28/2021
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: Altered sense of smell. A lot of things smell very bad; received first dose/second dose on 06May2021; This is a spontaneous report from a contactable other hcp. A 20-year-old male patient received first dose of BNT162B2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Right on 06May2021 (Batch/Lot Number: EW0167) as DOSE 1, SINGLE and second dose via an unspecified route of administration, administered in Arm Left on 06May2021 (Batch/Lot Number: ER8736) as DOSE 2, SINGLE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. The patient experienced altered sense of smell. a lot of things smell very bad Experiencing this for 3 months and received first dose/second dose on 06May2021. No treatment was received for the events. Outcome of the event altered sense of smell. a lot of things smell very bad was not recovered.; Sender's Comments: Based on the information provided, known drug safety profile and plausible temporal association, the causality between BNT162B2 and the event Parosmia cannot be completely excluded. The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, ethics committees. and investigators, as appropriate.

Other Meds:

Current Illness:

ID: 1646679
Sex: F
Age:
State: NJ

Vax Date: 07/22/2021
Onset Date: 07/01/2021
Rec V Date: 08/28/2021
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: This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA7484) via an unspecified route of administration in the left arm on 22Jul2021 at 17:30 (at the age of 39-year-old) as a single dose for COVID-19 immunisation. Medical history included sulfonamide allergy (allergy to sulfa). Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. on 23Jul2021 at 17:30, 24 hours after the initial dose, the patient upper left arm where the vaccine was injected broke out in large red hives. The patient stated, the hives went down as she took a Claritin and used Benadryl cream, but on an unknown date in Jul2021, she was left with a large red rash for about a week. On an unknown date in 2021, the patient had brown discoloration all over upper left arm that was beginning to scab off. Therapeutic measures were taken as a result of event hives and included treatment with CLARITIN and BENADRYL cream suggested by the pharma. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events upper left arm where the vaccine was injected broke out in large red hives and large red rash was resolved with sequelae on an unknown date in 2021. The clinical outcome of the events brown discoloration all over upper left arm and scab off was unknown at the time of this report.

Other Meds:

Current Illness:

ID: 1646680
Sex: F
Age:
State: NY

Vax Date: 08/04/2021
Onset Date: 08/05/2021
Rec V Date: 08/28/2021
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: Unevaluable event

Symptoms: Drooping of the face; Rash around forehead and eyes; swollen eyes; numb face spreading quickly; Alligator like skin and blotches drooping of the face; Alligator like skin and blotches drooping of the face; This is a spontaneous report from a contactable consumer (patient). A 18-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation; solution for injection, Lot Number: Fa7484), dose 1 via an unspecified route of administration, administered in Arm Left on 04Aug2021 16:00 (age at Vaccination 18 years) as dose 1, single for covid-19 immunisation at Pharmacy or Drug Store. Relevant medical history and concurrent conditions was none. Patient did not have any relevant past drug history. Patient did not receive any other medication within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient experienced rash around forehead and eyes, swollen eyes, numb face spreading quickly, alligator like skin and blotches, drooping of the face on 05Aug2021 at 12:00 AM. It was reported that the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that events caused emergency room/department or urgent care visit. Since the vaccination patient was not tested for COVID-19. There was no hospitalization. Patient took treatment for the events. The treatment medication included Prednisone and antihistamine. The case was reported as non-serious. The outcome of the events was reported as not recovered.

Other Meds:

Current Illness:

ID: 1646681
Sex: F
Age:
State: OR

Vax Date: 04/26/2021
Onset Date: 04/26/2021
Rec V Date: 08/28/2021
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: Test Date: 20210506; Test Name: Covid test/Nasal swab; Result Unstructured Data: Test Result:Negative

Allergies:

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

Symptoms: I felt out of body like I could not focus for the first day; increasingly more and more dizzy and put off it; I was also exhausted and could barely do anything; havent been able to work since I got the vaccine; This is a spontaneous report from a contactable consumer (patient). A 37-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: En6203), via an unspecified route of administration in the left arm on 26Apr2021 at 13:30 (at the age of 37-years-old) as DOSE 1, SINGLE for COVID-19 immunization. Patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had tested for COVID-19. The patient stated that on 26apr2021 14:00, she felt out of body like she could not focus for the first day and then increasingly more and more dizzy and put off it. She was also exhausted and could barely do anything, ended up in urgent care and then the ER. She had not been able to work since she got the vaccine and still struggle everyday with her energy and cognitive levels. The events were assessed to be serious (Disabling/Incapacitating). The events resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient underwent sars-cov-2 test: negative on 06May2021. The patient received treatment for the events. The clinical outcome for events was recovering.

Other Meds:

Current Illness:

ID: 1646682
Sex: M
Age:
State: MA

Vax Date: 05/21/2021
Onset Date: 07/13/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data: Test Date: 2021; Test Name: Blood test; Result Unstructured Data: Test Result:UNKNOWN; Test Date: 2021; Test Name: Computerised tomography; Result Unstructured Data: Test Result:UNKNOWN; Test Date: 2021; Test Name: Biopsy; Result Unstructured Data: Test Result:UNKNOWN; Test Date: 20210630; Test Name: Nasal Swab; Test Result: Negative

Allergies:

Symptom List: Injection site pain, Pain

Symptoms: lymph nodes in left side of neck, total 6 big and small nodes.; This is a spontaneous report from a contactable consumer, the patient. A 22-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew0188) via an unspecified route of administration in the left arm on 21May2021 at 14:30 (at the age of 22-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies. The patient did not receive any medication within 2 weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew0171) via an unspecified route of administration in the right arm on 30Apr2021 at 14:30 as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 30Jun2021, the patient underwent test with COVID-19 test (nasal swab) and the result was negative. On 13Jul2021 at 18:15, the patient experienced lymph nodes in left side of neck, total 6 big and small nodes. The event resulted in doctor or other healthcare professional office/clinic visit ,emergency room/department or urgent care . On an unknown date in 2021 patient underwent biopsy, unspecified blood test, (CT) examination and results were unknown. The clinical outcome of the event enlargement of lymph nodes was not recovered.

Other Meds:

Current Illness:

ID: 1646683
Sex: M
Age:
State: SC

Vax Date: 03/04/2021
Onset Date: 03/15/2021
Rec V Date: 08/28/2021
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: 202107; Test Name: NCS; Result Unstructured Data: Test Result:worsening of the chronicity of the radiculopathy; Test Date: 202107; Test Name: NCS; Result Unstructured Data: Test Result:acute denervation bilateral spinal muscles as well; Test Date: 202107; Test Name: NCS; Result Unstructured Data: Test Result:ight L5/S1 acute denervation; Test Date: 202106; Test Name: myelogram; Result Unstructured Data: Test Result:no change from prior

Allergies:

Symptom List: Injection site pain, Menorrhagia

Symptoms: new acute denervation bilateral spinal muscles as well as right L5/S1 acute denervation; I started falling by getting jolts down my right leg and the leg goes weak and I fall; I started falling by getting jolts down my right leg and the leg goes weak and I fall; worsening of the chronicity of the radiculopathy; jolts down my right leg; This is a spontaneous report from a contactable physician (Patient). A 55-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Lot Number: En6199) via intramuscular route of administration (age at vaccination 55-year) in Left Arm on 04Mar2021 at 02:30 as dose 1, single for COVID-19 immunization. Medical history included diabetes, hypertension, low testosterone, high triglycerides, Flu, latex, tetanus, chronic back issues, chronic L5/S1 radiculopathy, all from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously took Cymbalta and experienced allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination, but none new. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 15Mar2021 at 08:00 the patient experienced new acute denervation bilateral spinal muscles as well as right l5/s1 acute denervation, he started falling by getting jolts down his right leg and the leg goes weak and he fall, worsening of the chronicity of the radiculopathy. It was reported by the patient that "I have chronic back issues already with chronic L5/S1 radiculopathy. Mid-March I started falling by getting jolts down my right leg and the leg goes weak and I fall. It has progressively gotten worse to where I need a cane to walk. Had repeat myelogram in June because of this and no change from prior. Had NCS/EMG end of July showing worsening of the chronicity of the radiculopathy but also new acute denervation bilateral spinal muscles as well as right L5/S1 acute denervation. I continue to worsen". The patient underwent lab tests and procedures which included nerve conduction studies: worsening of the chronicity of the radiculopathy, nerve conduction studies: acute denervation bilateral spinal muscles as well, nerve conduction studies: right l5/s1 acute denervation, all in Jul2021; spinal myelogram: no change from prior in Jun2021. Therapeutic measures were taken as a result of the adverse events, PT. Neurology consult treatment was pending. The seriousness of the events was reported as serious (Disabling/Incapacitating). Adverse events resulted in Doctor or other healthcare professional office/clinic visit. The clinical outcome of the events was not recovered.; Sender's Comments: The reported events are assessed as possibly related to the suspect drug BNT162B2 based on plausible temporal association but consider also possible contributory effects from patient's medical history and/or concomitant medications. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Other Meds:

Current Illness:

ID: 1646684
Sex: M
Age:
State: NM

Vax Date: 03/24/2021
Onset Date: 03/27/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: SVT; Respiratory problems; This is a spontaneous report from a contactable consumer (patient himself). A 71-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Er2613), via an unspecified route of administration, administered in left arm on 24Mar2021 (age at vaccination: 71 years) as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history included diabetes mellitus. The patient did not take concomitant medications (patient did not take any other medications within 2 weeks of vaccination). The patient's historical vaccine included bnt162b2 on an unknown date at 14:00 in left arm as DOSE 1, SINGLE for covid-19 immunisation. The vaccine was administered in a hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 27Mar2021 12:00, the patient experienced svt (supraventricular tachycardia) and respiratory problems. Onset of SVT within 5 days on second shot also respriatory problems. All the events were considered to be disabling. The event of svt was treated with medications. The adverse events led to Doctor or other healthcare professional office/clinic visit, Disability or permanent damage. It was serios and seriousness criteria not resulted in death, life threatening, caused/prolonged hospitalization, congenital anomaly/birth defect but Seriousness criteria resulted in Disabling/Incapacitating. Prior to vaccination, the patient was diagnosed with COVID-19 nor the patient has been tested for COVID-19 since the vaccination. The outcome of the events was not recovered. The device date was 07Aug2021. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1646685
Sex: F
Age:
State: FL

Vax Date: 04/10/2021
Onset Date: 06/06/2021
Rec V Date: 08/28/2021
Hospital: Y

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

Lab Data: Test Date: 2021; Test Name: Nasal Swab; Result Unstructured Data: Test Result:Unknown results

Allergies:

Symptom List: Nausea, Pain in extremity, Pyrexia

Symptoms: Kidney failure; Lupus Nephritis; This is a spontaneous report received from a contactable consumer. This consumer (patient) reported for herself that the 61-year-old female patient received second dose of bnt162b2 (BNT162B2, COVID 19, brand: Pfizer Covid19) at the age of 61-year-old, dose 2 via an unspecified route of administration, administered in Arm Left on 10Apr2021 14:00 (Batch/Lot Number: ER8737) as dose 2, single for covid-19 immunisation. Medical history included Diabetis from an unknown date and unknown if ongoing, High blood pressure from an unknown date and unknown if ongoing. She is not pregnant or not pregnant at the time of vaccination. No known allergies. The patient's concomitant medications were not reported. The patient previously took first dose of bnt162b2 (BNT162B2, COVID 19, brand: Pfizer Covid19) at the age of 61-year-old in Arm Left on 20Mar2021 14:00 (Batch/Lot Number: EP7534) for covid-19 immunization. The patient experienced kidney failure on 06Jun2021 15:00 with outcome of not recovered , lupus nephritis on 06Jun2021 15:00 with outcome of not recovered. Seriousness criteria of the events was hospitalization, disability, medically significant, life threatening. The patient was hospitalized for kidney failure and lupus nephritis for 5 days. The patient underwent lab tests and procedures which included sars-cov-2 test (Nasal swab): unknown results on 2021. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The adverse event result in [Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event), Disability or permanent damage]. It is unknown if the treatment received. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19.

Other Meds:

Current Illness:

ID: 1646686
Sex: F
Age:
State: NJ

Vax Date: 04/02/2021
Onset Date: 04/04/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data: Test Date: 20210404; Test Name: Nerve test; Result Unstructured Data: Test Result:20% damaged; Comments: which was showing 20% of my nerves were damaged.

Allergies:

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: I got muscle twitches in the left arm where it was injected/it has progressed to twitching over my whole body; severe pain pins and needles electric shocks; severe pain pins and needles electric shocks; severe pain pins and needles electric shocks; feeling like I am wearing Gloves and socks in my arms and legs; My balance is affected; 20% of my nerves are damaged; This is a spontaneous report from a contactable consumer (patient). A 52-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: ER8727), via an unspecified route of administration (at the age of 52-years), administered in arm left on 02Apr2021 at 11:00 as dose 2, single for COVID-19 immunization. Medical history included hypothyroidism and high blood pressure, and had allergies to penicillin. Concomitant medications included atenolol, received within 2 weeks of vaccination. The patient historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EN6z06), via an unspecified route of administration (at the age of 52-years), administered in arm left on 15Mar2021 at 09:30 as dose 1, single for COVID-19 immunization and experienced no reaction on previous exposure to drug. The patient did not receive any other vaccine 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. The patient was not pregnant at time of vaccination. On 04Apr2021, It was reported that after the second dose I got muscle twitches in the left arm where it was injected. Now it has progressed to twitching over her whole body. now have severe pain pins and needles electric shocks and feeling like she was wearing, gloves and socks in her arms and legs. Her balance was affected. Her neurologist did a nerve test which was showing 20% of my nerves were damaged. The events were considered as serious (Disabling/Incapacitating) as per reporter. The treatment was not received for all the events. The adverse event result in physician office visit and emergency room visit. The facility where the most recent COVID-19 vaccine was administered was reported as other. The clinical outcome for all the events was reported as not recovered.

Other Meds: ATENOLOL

Current Illness:

ID: 1646687
Sex: F
Age:
State: TX

Vax Date: 01/12/2021
Onset Date: 01/21/2021
Rec V Date: 08/28/2021
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 Date: 20210121; Test Name: EMG; Result Unstructured Data: Test Result:Negative; Test Date: 20210517; Test Name: EMG; Result Unstructured Data: Test Result:Normal; Test Date: 20210203; Test Name: MRI LUMBAR; Result Unstructured Data: Test Result:NORMAL; Comments: Leg weakness worse; Test Date: 20210424; Test Name: MRI BRAIN; Result Unstructured Data: Test Result:Normal; Test Date: 20210129; Test Name: CERVICAL MRI spondylosis; Result Unstructured Data: Test Result:no myelopathy; Test Date: 20210315; Test Name: PCR; Test Result: Negative ; Comments: Nasal Swab

Allergies:

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

Symptoms: Same neuropathy; Heart racing better; Blepharospasm L eye; Worse Fatigue Weakness; Worse Fatigue Weakness; Tachy/bp change; Gastric paresis; Glove stocking pins and temp changes; Dry eyes; EXTENSIVE SFN; SHAKY trembling hands/shakiness/muscle shakiness; More leg weakness and paresthesia constant -Felt heavy; Tingling bilat; Leg weakness/unsteady/leg weakness worse/Legs give out; This is a spontaneous report from a contactable consumer (patient, self-reported). A 51-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EL3248 and expiry date was not reported), via Intramuscularly, in Arm Left, on 12Jan2021 at 14:00 PM (age at vaccination: 51 years), as a single dose for COVID-19 immunization at hospital. The patient was not pregnant at the time of vaccination. The patient's medical history was not reported. The patient did not have known allergies. Concomitant medications included bupropion hydrochloride (WELLBUTRIN), DHEA, vit D [VITAMIN D NOS], calcium, estrogen NOS, hydroxyprogesterone caproate (PROGE), and testosterone. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was tested for COVID-19. On 10Feb2021, the patient experienced more leg weakness and paresthesia constant -Felt heavy. On 23Mar2021, the patient had shaky trembling hands/shakiness/muscle shakiness. On 03May2021, the patient had extensive SFN. On 17May2021, the patient experienced gastric paresis, glove stocking pins and temp changes, dry eyes, and tachy/bp change. On 21May2021, the patient had worse fatigue weakness. On 11Jun2021, the patient had blepharospasm L eye. On 20Jun2021, the patient visited to neurologists and think vaccine related and sending her to Infectious disease next week. On 21Jun2021, the patient experienced tingling bilat and neurology (withheld) - complete assessment done with 5 Day steroid taper helped paresthesia and symptoms recurred on day 0. The patient had leg weakness/unsteady/leg weakness worse/Legs give out. On an unspecified date in Jul2021, the patient experienced same neuropathy and heart racing better. The patient underwent lab tests and procedures which included electromyogram: negative on 21Jan2021, electromyogram: normal on 17May2021, magnetic resonance imaging LUMBAR: normal on 03Feb2021 Leg weakness worse, magnetic resonance imaging BRAIN: normal on 24Apr2021, CERVICAL magnetic resonance imaging neck spondylosis: no myelopathy on 29Jan2021, and sars-cov-2 test: negative on 15Mar2021 Nasal Swab. The adverse event result in doctor or other healthcare professional office/clinic visit. The patient received treatment for the events. Outcome of the events was not recovered.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine cannot be excluded for the reported events of "Neuropathy" "Gastroparesis" due to temporal relationship and current known drug safety profile. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate

Other Meds: WELLBUTRIN; DHEA; VIT D [VITAMIN D NOS]; CALCIUM; ESTROGEN NOS; PROGE; TESTOSTERONE

Current Illness:

ID: 1646688
Sex: F
Age:
State: PA

Vax Date: 03/31/2021
Onset Date: 04/03/2021
Rec V Date: 08/28/2021
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: Diagnosed with vitiligo in a small area in back, two spots developed within 2 days of second dose.; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the left arm on 31Mar2021 at 12:30 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history included known allergies to penicillin. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202) via an unspecified route of administration in the left arm on 10Mar2021 at 12:30 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 03Apr2021, within 2 days of second dose, the patient developed two spots and was diagnosed with vitiligo in a small area in the back. The patient had no family history nor any other prior indications. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the event which included treatment with steroid and topical medication. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event diagnosed with vitiligo in a small area in back was not recovered at the time of this report.

Other Meds:

Current Illness:

ID: 1646689
Sex: M
Age:
State: NJ

Vax Date: 04/16/2021
Onset Date: 04/22/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data: Test Date: 2021; Test Name: Blood test; Result Unstructured Data: Test Result:Unknown result

Allergies:

Symptom List: Injection site pain

Symptoms: Vomiting when eating pain in stomach.; Vomiting when eating pain in stomach.; Ive lost over 40 pounds since this began; Still unable to eat and keep Food down; Muscle loss; This is a spontaneous report received from a contactable consumer or other non-health care professional (patient) reported for himself that. A 51-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: ER8731), via an unspecified route of administration, administered in right arm on 16Apr2021 09:00 (at the age of 51-years-old) as dose 2, single for COVID-19 immunization. Medical history included migraine from an unknown date and unknown if ongoing. Concomitant medication included vitamins nos (VITAMINS NOS) taken for migraine, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, was the patient did not diagnosed with COVID-19. Since the vaccination, did not patient been tested for COVID-19. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: ER8727) via an intramuscular route of administration, administered in right arm on 26Mar2021 09:00 (at the age of 51-years-old) as dose 1, single for COVID-19 immunization. On 22Apr2021 07:00 patient experienced, vomiting when eating pain in stomach. Cannot keep anything down can only manage to hold down hard pretzels and cheese. Patient had lost over 40 pounds since this began. No medication can help with the pain in his stomach or help alleviate any of the pain. Still unable to eat and keep food down. Patient had lost over 40 pounds since this began. (Withheld) was worried now about muscle loss. The events assessed as serious (medically significant). Patient received treatment medication for vomiting and pain in stomach. Patient visited doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included blood test: unknown result (nothing shows wrong with my insides) in 2021. The outcome of the events was reported as not recovered.

Other Meds: VITAMINS NOS

Current Illness:

ID: 1646690
Sex: F
Age:
State: NV

Vax Date: 07/30/2021
Onset Date: 07/30/2021
Rec V Date: 08/28/2021
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: 20210730; Test Name: BP; Result Unstructured Data: Test Result:198/120; Comments: 196/110 plus still at 110 after 2 hours rushed to hospital

Allergies:

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

Symptoms: my face began to swell; my BP went to 198/120 plus 110/196/110 plus still at 110; I was unable to breath and chocking on my own fluids in my lungs; My lungs were chocking me; This is a spontaneous report from a contactable consumer (patient). A 41-years-old female non-pregnant patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection) via an unspecified route of administration, administered in left arm on 30Jul2021 at 14:15 (Batch/Lot Number: FA7485) as a single dose for covid-19 immunization. Medical history included chronic obstructive pulmonary disease (COPD), chronic myeloid leukaemia (CML) in remission and heart condition. Concomitant medications included topiramate, metoprolol and lisinopril; all taken for an unspecified indication from an unknown date. 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 had not been tested for COVID-19. About thirty minutes after the injection at 16:00, the patient face began to swell, and her BP went to 198/120 plus 110. Then 2 hours later she was rushed to hospital and was unable to breath and chocking on her own fluids in her lungs. She arrived at hospital unable to breathe nor catch her breath. Her lungs were chocking her, and her BP was 196/110 plus still at 110. After entering emergency room (ER) they had no clue what to do and treated her as a covid patient. She needed a nebulizer and was told the ER doctor couldn't give it to her there and no beds were available. The doctor gave her pills without explaining and then kept treating her like she came in for covid. She had the worst reaction of her life and was treated horribly. The doctor did not give her discharge paperwork, nor did hospital follow up. It was not until she went yesterday to her GP and he even said the notes were missing information, also the doctor supposedly sent me with prescriptions which she never got. She encountered, all side effects of the shot. The adverse events resulted in emergency room/department or urgent care. The outcome of the events was recovered with sequel. No follow up attempts are possible. No further information is expected.; Sender's Comments: Based on plausible dose-event temporal relationship likely hypersensitivity post-vaccination the causal role of bnt162b2 vaccine cannot be excluded for reported events. Underlying CMLL and chronic onstructive pulmonary disease are significant risk factors. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate

Other Meds: TOPIRAMATE; METOPROLOL; LISINOPRIL

Current Illness:

ID: 1646691
Sex: M
Age:
State: CO

Vax Date: 08/03/2021
Onset Date: 08/05/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Some pain right from the arm where there shot was administered coming right up to the area of collar bone on right/ There seems to be some sort of crumb forming around collar bone and very painful; There seems to be some sort of crumb forming around collar bone; Some pain right from the arm where there shot was administered; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old, male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EWO198) via an unspecified route of administration in the right arm on 03Aug2021 at 13:45 (at the age of 42-year-old) as a single dose for COVID-19 immunisation. Medical history and known allergies were reported as not available. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included ibuprofen (MANUFACTURER UNKNOWN) for unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EWO186) via an unspecified route of administration in the right arm on 13Jul2021 at 11:30 (at the age of 42-year-old) as a single dose for COVID-19 immunisation. On 05Aug2021 at 04:30, the patient experienced some pain right from the arm where the shot was administered and came right up to the area of collar bone on right, there seemed to be some sort of crumb forming around collar bone and was very painful. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events some pain right from the arm where there shot was administered and came right up to the area of collar bone on right, there seemed to be some sort of crumb forming around collar bone and very painful were not recovered at the time of this report.

Other Meds: IBUPROFEN

Current Illness:

ID: 1646692
Sex: M
Age:
State: PA

Vax Date: 05/25/2021
Onset Date: 05/26/2021
Rec V Date: 08/28/2021
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 Date: 202106; Test Name: PCR: Nasal Swab; Test Result: Negative ; Comments: Nasal Swab

Allergies:

Symptom List: Tremor

Symptoms: body aches/ Body continues to feel very achy; slight fever/occasional low fever; chest pain; difficulty taking a deep breath; inability to exercise; sleep disturbances; Body continues to feel very achy like the flu; shooting pains in limbs; occasional tremor in hands and feet; This is a spontaneous report from a contactable consumer (reported for himself). A 20-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EW0178/Batch number was not reported), dose 2 via an unspecified route of administration on 25May2021 (at the age of 20-years-old) as dose 2, single for covid-19 immunisation at Pharmacy. Medical history included pectus excavatum from an unknown date and unknown if ongoing (Other medical history: Medical history includes Nuss procedure to correct pectus excavatum), mite allergy from an unknown date and unknown if ongoing (Known allergies: only dust mites). The patient's concomitant medications were not reported. The patient did not receive any other vaccines on the same day of vaccine vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medications within 2 weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient been tested for COVID-19. The patient previously received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EW0176/Batch number was not reported), dose 1 via an unspecified route of administration on 04May2021 (at the age of 20-years-old) as dose 1, single for covid-19 immunisation at Pharmacy. On 26May2021 at 10:00, the patient experienced body aches/ body continues to feel very achy, slight fever/occasional low fever, chest pain, difficulty taking a deep breath, inability to exercise, sleep disturbances, body continues to feel very achy like the flu, shooting pains in limbs and occasional tremor in hands and feet. The case assessed as serious disability. The reporter stated the events result in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on an unspecified date in Jun2021 (Nasal Swab). Therapeutic measures were taken as a result of events included treatment with Diagnostic tests and trial of medicines. The outcome of the events was not resolved. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1646693
Sex: F
Age:
State: FL

Vax Date: 08/03/2021
Onset Date: 08/03/2021
Rec V Date: 08/28/2021
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: 20210804; Test Name: PCR; Result Unstructured Data: Test Result:Negative; Comments: Nasal Swab; Test Date: 20210805; Test Name: PCR; Result Unstructured Data: Test Result:Negative; Comments: Nasal Swab; Test Date: 20210806; Test Name: PCR; Result Unstructured Data: Test Result:Negative; Comments: Nasal Swab

Allergies:

Symptom List: Erythema, Pruritus

Symptoms: Migraine; Vomit; Nose bleed; Headache; There was a faint but strange "dreamlike" feeling when I stood up & some faint distortions of light; This is a spontaneous report from a contactable consumer or other healthcare professional (patient). A 43-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot number was unknown), via an unspecified route of administration, administered in Arm Left on 03Aug2021 (at the age of 43-years-old) as dose 1, single for covid-19 immunization at pharmacy or drug store. Medical history included hyperemesis gravidarum (she had a pregnancy complication 10 years ago) from an unknown date and unknown if ongoing. Patient had no known allergies. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No list of any other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination/post vaccination, the patient had been tested for COVID-19. Patient had excellent health and never needed any hospitalizations or long-term medications. Received Pfizer mRNA vaccine. Ok for about 15 minutes. 03Aug2021 5:18pm started to leave the pharmacy but there was a faint but strange dreamlike feeling when she stood up and some faint distortions of light so she stayed for a bit until she knew it was safe to drive. 7:15pm she experienced the first migraine of her life, it caused her to vomit, and the first nosebleed of her life approximately an hour after the shot. She had to lie down with a wet rage on her face due to the light, so it was hard to say the exact time. After she vomited, she felt well enough to drive to the ER. At 8:24pm arrived at the ER at the hospital so they could check her and analyze what was happening with the nosebleed. Now just headache which she had expected. They took her vitals and admitted her but unfortunately, due to the outbreak, there were over 100 people ahead of her and it was night so after several hours she needed to go home and go to bed so she did a follow up with her PCP the next morning. The adverse event resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 04Aug2021 (nasal swab), sars-cov-2 test: negative on 05Aug2021 (nasal swab), sars-cov-2 test: negative on 06Aug2021 (nasal swab). No treatment was received. The outcome of events syncope, migraine, epistaxis, vomiting and headache was reported as recovered with lasting effects. No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events Syncope, migraine, headache, vomiting, epistaxis and suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Other Meds:

Current Illness:

ID: 1646694
Sex: F
Age:
State: FL

Vax Date: 04/05/2021
Onset Date: 04/19/2021
Rec V Date: 08/28/2021
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: the reaction started with a rush like I was going to faint.; feel a surge or flush of heat followed by my heart racing/each day I'd be woken by the surge/flush and all symptoms repeating; feel a surge or flush of heat followed by my heart racing/Palpitations; anxiety; inability to eat; my insides felt like they were being squeezed; This is a spontaneous report from contactable consumer (patient, self-reported). A 64-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: ER 8733 and expiry date was not reported), via an unspecified route of administration, in Arm Left, on 05Apr2021 at 11:30 AM (age at vaccination: 64 years), as a single dose for COVID-19 immunization at Pharmacy or Drug Store. The patient was not pregnant at the time of vaccination. The patient's medical history included colitis ulcerative. The patient previously took Tramadol, Pseudoephedrine, Dextromethorphan, and Keflex which had known allergies. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EN 6208 and expiry date was not reported), via an unspecified route of administration, in Arm Left, on 13Mar2021 at 12:45 PM (age at vaccination: 64 years), as a single dose for COVID-19 immunization at Pharmacy or Drug Store. Concomitant medication included mesalamine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient reported that on 19Apr2021 at 12:15 PM, (2 weeks to the day after her 2nd shot), the reaction started with a rush like I was going to faint. For 11 days following her body would feel a surge or flush of heat followed by her heart racing, palpitations, anxiety, inability to eat, her insides felt like they were being squeezed. This lasted for the most part, the entire day. When it subsided, she felt normal, but each day she would be woken by the surge/flush and all symptoms repeating. The adverse event result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient received treatment clonazepam to control the palpitations. Outcome of the event the reaction started with a rush like I was going to faint was recovered on an unspecified date and for all other events, it was recovered on 30Apr2021 at 12:15. Follow-up attempts are completed. No further information is expected.

Other Meds: MESALAMINE

Current Illness:

ID: 1646695
Sex: F
Age:
State: NC

Vax Date: 07/26/2021
Onset Date: 07/27/2021
Rec V Date: 08/28/2021
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: 2021; Test Name: COVID-19; Result Unstructured Data: Test Result:Unknown results; Comments: Since the vaccination, has the patient been tested for COVID-19?:Yes

Allergies:

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

Symptoms: Swelling and bruised left leg pain so severe can't walk; Swelling and bruised left leg pain so severe can't walk; Swelling and bruised left leg pain so severe can't walk/ leg still painful; Swelling and bruised left leg pain so severe can't walk; This is a spontaneous report from a contactable consumer, the patient. A 65-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in arm left on 26Jul2021 at 10:00 (age at vaccination: 65-year-old, non-pregnant) (Batch/Lot Number: FA3980) as DOSE 1, SINGLE for covid-19 immunization at a Pharmacy or Drug Store. The patient medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had tested for COVID-19. Concomitant medication included celecoxib (CELEBREX) taken for an unspecified indication, start and stop date were not reported. The patient previously took Cortisone shot in left knee on 25Jun2021. Patient had known drug allergies to Codiene. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 27Jul2021, the patient experienced swelling and bruised left leg pain so severe can't walk. Two weeks later leg still painful and difficult to walk. The patient underwent lab tests and procedures which included Sars-Cov-2 test: unknown results on an unknown date in 2021. Patient did not receive any treatment for the events. The events resulted in emergency room visit. There was no hospitalization/ prolonged hospitalization reported. The seriousness criteria reported as disability. The outcome of the events was not recovered. No follow-up attempts are possible. No further information is expected.

Other Meds: CELEBREX

Current Illness:

ID: 1646696
Sex: M
Age:
State: NJ

Vax Date: 04/18/2021
Onset Date: 04/21/2021
Rec V Date: 08/28/2021
Hospital: Y

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

Lab Data: Test Date: 20210430; Test Name: COVID test type: Blood test; Test Result: Negative ; Comments: Post vaccination

Allergies:

Symptom List: Asthenia, Chills, Headache, Myalgia

Symptoms: Pulmonary fibrosis; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 58-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection), via an unspecified route of administration, administered in right arm on 18Apr2021 12:30 (age at vaccination was 58 years) (Batch/Lot Number: EW0161) as dose 1, single for covid-19 immunization. Medical history included cardiac failure congestive from an unknown date. Concomitant medication included valsartan (VALSARTAN) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had tested negative for COVID-19 since the vaccination. On 21Apr2021, at 12:00am after receiving the vaccine the patient experienced pulmonary fibrosis resulted in emergency room visit, Disability or permanent damage. The patient stayed 7 days in the hospital. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 30Apr2021 Post vaccination. The patient received treatment for the events. The outcome of the event was not recovered. Follow-up attempts completed. No further information expected

Other Meds: VALSARTAN

Current Illness:

ID: 1646697
Sex: M
Age:
State: TX

Vax Date: 08/06/2021
Onset Date: 08/07/2021
Rec V Date: 08/28/2021
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: I must have blacked out for a second; Woke up cold the following morning; I then felt light headed. I couldn't hold my head up; I couldn't hold my head up; feeling weak; I hit my head when I fell.; arm was sore where I got the shot.; This is a spontaneous report from a contactable consumer (reported himself). A 15-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: EW0183), via an unspecified route of administration, administered in arm right on 06Aug2021 17:30 (age at vaccination 15-year-old) as dose 1, single for COVID-19 immunisation and school or student health clinic. The patient medical history was not reported. The patient concomitant medication was vitamin C (unspecified) received within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient stated that on 07Aug2021 09:00, he woke up cold the following morning. Patient sat down to eat breakfast at the kitchen table. Patient stated that "I then felt lightheaded. I couldn't hold my head up". Patient stated that his body just went limp. Patient was feeling weak, then patient went sideways. Patient stated that "I must have blacked out for a second" because the next thing patient know, her mother was picking me up from the floor. Patient stated that "I hit my head when I fell". The rest of the day patient felt weak, his head hurt, and patient stated that "arm was sore where I got the shot". The patient received acetaminophen as the treatment for the events. The patient was not hospitalization. Since the vaccination, the patient had not tested for COVID-19. The outcome of the events was resolving. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1646698
Sex: F
Age:
State: NY

Vax Date: 07/28/2021
Onset Date: 07/29/2021
Rec V Date: 08/28/2021
Hospital: Y

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: Test Date: 20210807; Test Name: Nasal Swab; Test Result: Negative

Allergies:

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

Symptoms: Severe chest tightness and severe pain; Severe chest tightness and severe pain; flu like symptoms; chest pains have gotten worse; This is a spontaneous report from a contactable consumer or other non hcp (patient herself). A 28-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch Number/Lot Number: EW0185), via an unspecified route of administration, administered in Arm Left on 28Jul2021 15:00 (at the age of 28-Years-old) as dose 1, single for COVID-19 immunisation. Facility where the most recent COVID-19 vaccine was administered was reported as other. Medical history was reported as none. There were no concomitant medications. No known allergies were reported. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine (prior vaccination was none). No other medications the patient received within 2 weeks of vaccination. The patient experienced severe chest tightness and severe pain, flu like symptoms and chest pains have gotten worse on 29Jul2021. The patient was hospitalized for severe chest tightness and severe pain, flu like symptoms and chest pains have gotten worse for 1 day. The adverse event resulted in visiting of emergency room/ department or urgent care. The adverse events were considered as serious with seriousness criteria of hospitalization. Patient went to the emergency room for pain and chest pain was worse over 9 days. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 07Aug2021. No treatment was received for the reported events. The outcome of the events was reported as not recovered.

Other Meds:

Current Illness:

ID: 1646699
Sex: F
Age:
State: PA

Vax Date: 04/29/2021
Onset Date: 04/01/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data: Test Name: blood work; Result Unstructured Data: Test Result:Low; Comments: vitamin D level was low; Test Name: X-rays; Result Unstructured Data: Test Result:rheumatoid arthritis

Allergies:

Symptom List: Pain in extremity

Symptoms: I bent over and I could hardly get up; when I sit down I want to shut my eyes but yet I cannot sleep; It takes all my energy just to do something; Rheumatoid arthritis; my back hurts specially the lower back; Lost my appetite. I have to force my self to eat as I don't want to eat anymore; It (arm) is still sore and the pain shot up to my shoulder, and that pain comes and goes; Pulled muscle; I could not move my arm around for a couple days; My stomach hurts at right side; It (arm) is still sore; Tired; This is a spontaneous report from a contactable consumer (patient). A 71-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection) via an unspecified route of administration in left arm on 08Apr2021 (Batch/Lot Number: ER8729) and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection) via an unspecified route of administration in left arm on 29Apr2021 (Batch/Lot Number: ER8736) both as a single dose for COVID-19 immunization. Age at vaccination was 71-years-old. Medical history included blood cholesterol, high blood pressure, restless legs syndrome (Patient mentioned that she has restless leg syndrome for that she was given something but did not work so she does not even take it. The doctor gave her something that was really for parkinson's, but she was never diagnosed with parkinson's. She does not take it and it doesn't help and she does better without it.) and reflux. Concomitant medications included rosuvastatin taken for blood cholesterol, hydrochlorothiazide, triamterene (TRIAMTERENE AND HYDROCHLOROTHIAZIDE) taken for high blood pressure and omeprazole 40 mg taken for reflux, colecalciferol (VITAMIN D3) for unknown indication. Patient reported that back in April, it was the beginning and the end, patient had that two shots of Pfizer vaccine (confirmed as Pfizer COVID vaccine) and since then patient had been extremely tired and never felt like this before and it's a tired that patient couldn't explain, when she sat down she wanted to shut her eyes but yet she could not sleep (Apr2021). Patient mentioned that if she had 20 hours of sleep since April, she was lucky. It took all her energy just to do something. Patient further reported that that was not the only thing, in the beginning, she got a shot, she understands her arm hurts because she does get vaccinated every year (further not clarified) and her arm gets sore but this time it was still sore and the pain shot up to her shoulder, and that pain comes and goes. Patient confirmed she was still experiencing the pain. Last month (Jul2021), she bent over and she could hardly get up. She went to numerous visits to doctors, and at first the doctor said she pulled a muscle, the doctor gave her a shot for pain, pain meds and muscle relaxant (names not clarified), which she didn't like to take but she took them anyway but they did not help. So, she called her doctor, and she went to see the physician assistant who did not do anything and said she wanted more drugs. Patient went back to patient first and demanded to have X-rays of her back, to which doctor said no, you don't need it. She said her stomach hurts at right side and her back hurts, especially the lower back, X-rays were taken and confirmed as rheumatoid arthritis. She was extremely tired. Patient thought she lost 5 pounds. She also lost her appetite. She had to force herself to eat as she did not want to eat anymore. Patient could not move her arm around for a couple days. On an unspecified date, the patient underwent lab test which included X-rays: rheumatoid arthritis and blood work: Low (vitamin D level was low) work was done, she thought it was before the COVID-19, but she was not sure. Her vitamin D level was low so she was told to take vitamin D3. The outcome of the event I bent over and I could hardly get up it was not recovered while for the other event was unknown. Follow-up attempts are completed. No further information is expected.

Other Meds: ROSUVASTATIN; TRIAMTERENE AND HYDROCHLOROTHIAZIDE; OMEPRAZOLE; VITAMIN D3

Current Illness:

ID: 1646700
Sex: U
Age:
State: NC

Vax Date: 08/02/2021
Onset Date: 08/01/2021
Rec V Date: 08/28/2021
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: I had a seizure before, I got down and head hit on the wall.; I had a seizure before, I got down and head hit on the wall.; I had a seizure before, I got down and head hit on the wall.; I have neuropathy in my head so bad. It's very hard for me to write.; I can barely walk.; I am suffering so bad; This is a spontaneous report from a contactable consumer (patient). A 90-year-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: Unknown) via an unspecified route of administration on 02Aug2021 (at the age of 90 years old) as dose 1, single for COVID-19 immunization. Medical history included menstrual seizure, iritis. Concomitant medication included "lot of medications" as reported by the patient. No other vaccine was administered prior to COVID vaccine. The patient experienced "i had a seizure before, i got down and head hit on the wall" on 06Aug2021, "i have neuropathy in my head so bad, it's very hard for me to write, i am suffering so bad, i can barely walk" on an unspecified date on Aug2021. Patient have lot of medical problems, and lot of health issues but well. Patient wouldn't feeling that bad, just the few weeks before, patient was diagnosed with iritis and have history of having menstrual seizures. Patient took the vaccination this past Monday (02Aug2021) and patient was going on well. This Friday (06Aug2021) after patient took it, When patient was walked into the room that, patient go to wait. Patient had a seizure before, patient got down and head hit on the wall. Patient took the first one on Monday and due to take second which the 23rd of this month. What to do. Patient was suffering so bad. Patient don't feel up to, have neuropathy in head so bad It's very hard for patient to write. Outcome of all the events were unknown. The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1646701
Sex: M
Age:
State: TX

Vax Date: 08/03/2021
Onset Date: 08/04/2021
Rec V Date: 08/28/2021
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 Date: 20210804; Test Name: body temperature; Result Unstructured Data: Test Result:104 or 105; Comments: fever at 03:00; Test Date: 20210804; Test Name: body temperature; Result Unstructured Data: Test Result:104; Comments: fever - morning after vaccination; Test Date: 20210806; Test Name: body temperature; Result Unstructured Data: Test Result:102

Allergies:

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

Symptoms: fever/the fever started to skyrocket to 104 or 105.; Dry throat; feeling a bit nauseous; lower body feels weak; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program. A 14-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in Arm Right on 03Aug2021 16:00 (Batch/Lot Number: SC3180) as dose 1, single for COVID-19 immunization at a pharmacy. The patient has no medical history and concomitant medications. No history of previous immunization with the Pfizer vaccine. No additional vaccines administered on same date. No vaccinations 4 weeks prior. No relevant tests. On 04Aug2021 03:00, the patient experienced fever/the fever started to skyrocket to 104 or 105, dry throat, feeling a bit nauseous, and lower body feels weak. The patient got the fever of 104 in the morning after the vaccine, now it has lowered to 102 but stayed consistently at 102. He has been taking ibuprofen 600mg for the fever. He took them every eight hour, one each eight hours. It has been breaking up his fever since it lowered it from 104 to 102. The patient underwent lab tests and procedures which included body temperature: 104 or 105 (fever) on 04Aug2021 at 03:00, body temperature: 104 (fever) on 04Aug2021 morning after vaccination, and body temperature: 102 on 06Aug2021. The outcome of the event fever and dry throat was not recovered, for the event nauseous was recovered on an unspecified date, for lower body feels weak was recovered on 04Aug2021. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1646702
Sex: F
Age:
State: FL

Vax Date: 08/03/2021
Onset Date: 08/03/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Ringing in Left ear; Low nausea; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3180) via an unspecified route of administration in the left arm on 03Aug2021 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. Other medical history was reported as none. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 03Aug2021, the patient experienced ringing in left ear and low nausea. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events ringing in left ear and low nausea was not recovered at the time of this report.

Other Meds:

Current Illness:

ID: 1646703
Sex: M
Age:
State: NJ

Vax Date: 04/17/2021
Onset Date: 06/01/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Vomiting

Symptoms: Arthritis pain in finger of dominant hand on a daily basis, started to occur 2 months after receiving 2nd dose. I wake up with my ring finger folded and all fingers feeling very stiff. I need to stretch my hand to get relief.; Arthritis pain in finger of dominant hand on a daily basis, started to occur 2 months after receiving 2nd dose. I wake up with my ring finger folded and all fingers feeling very stiff. I need to stretch my hand to get relief.; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the left arm on 17Apr2021 at 09:00 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. The patient previously had shellfish and experienced shellfish allergy. Concomitant medications taken within two weeks of vaccination included low dose acetylsalicylic acid (ASPIRIN). The patient previously took ciprofloxacin (CIPRO) for unknown indication on unknown date and experienced drug allergy. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the left arm on 28Mar2021 at 09:00 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced arthritis pain in finger of dominant hand on a daily basis, started to occur from 01Jun2021 at 06:30, two months after receiving second dose. The patient woke up with his ring finger folded and all fingers feeling very stiff. The patient needed to stretch his hand to get relief. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. The clinical outcome of the event arthritis pain in finger of dominant hand on a daily basis, started to occur from 01Jun2021 at 06:30, two months after receiving second dose; the patient woke up with his ring finger folded and all fingers feeling very stiff; the patient needed to stretch his hand to get relief was not resolved at the time of this report.

Other Meds: ASPIRIN [ACETYLSALICYLIC ACID]

Current Illness:

ID: 1646704
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/28/2021
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: Moderate menstrual cramps; Back cramps; Early menstrual cycle; This is a spontaneous report from a non-contactable healthcare professional, the patient. A 25-year-old female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. Medical history included latex allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included ethinylestradiol; levonorgestrel (SETLAKIN) for unspecified indication from an unknown date. On an unknown date, the patient experienced moderate menstrual cramps, back cramps and early menstrual cycle. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event moderate menstrual cramps, back cramps and early menstrual cycle was unknown at the time of report. No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.

Other Meds: SETLAKIN

Current Illness:

ID: 1646705
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/28/2021
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: Tested for COVID; Test Result: Positive.

Allergies:

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

Symptoms: This is a spontaneous report from a contactable consumer. This consumer reported for a Physician. A male patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: unknown, expiry date: unknown) via unspecified route of administration on an unspecified date as dose 1, single and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: unknown, expiry date: unknown) via intramuscular route of administration on an unspecified date as dose 2, single for COVID-19 immunisation. Patient's medical history and concomitant medications were not reported. It was unknown whether the patient receive any other vaccines within 4 weeks prior to the COVID vaccine and any other medications within 2 weeks of vaccination. It was unknown whether prior to vaccination, the patient diagnosed with COVID-19, and whether since the vaccination, the patient been tested for COVID-19. On an unspecified date, patient was tested positive for COVID. Doctor or other healthcare professional office/clinic visit took place due to the adverse events. The patient underwent lab test for SARS-CoV-2, with results as positive on an unspecified date. The outcome of events was unknown. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1646706
Sex: F
Age:
State: LA

Vax Date: 08/02/2021
Onset Date: 08/03/2021
Rec V Date: 08/28/2021
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: Heart palpitations for 3 days; Muscle weakness; Shooting pain along whole right side; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 02Aug2021 at 17:30 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. The patient did not receive any medication within 2 weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 03Aug2021 at 08:00, the patient experienced heart palpations for 3 days, muscle weakness and shooting pain along the whole right side which was ongoing at the time of this report. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the event heart palpations was resolved on 06Aug2021 and muscle weakness and shooting pain along whole right side were not resolved at the time of this report. The lot number for BNT162b2 was not provided and will be requested during follow-up.

Other Meds:

Current Illness:

ID: 1646707
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/28/2021
Hospital:

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

Lab Data: Test Name: COVID Test; Result Unstructured Data: Test Result:COVID; Comments: Covid_tested_post_vaccination: Yes

Allergies:

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

Symptoms: A person who was fully vaccinated and caught covid.; A person who was fully vaccinated and caught covid.; This is a spontaneous report from a non-contactable consumer (patient). A patient of unspecified age and gender received and first dose of bnt162b2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN, lot number was not reported) via an unspecified route of administration on an unspecified date as dose 1, single and second dose of bnt162b2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN, lot number was not reported) via an unspecified route of administration on an unspecified date as dose 2, single both for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Reported Event that video (link content) shows a person who was fully vaccinated and caught covid. I am unsure of the type of vaccine received. The video explains progression of symptoms. On an unspecified date, the patient experienced a person who was fully vaccinated and caught covid. No seriousness criteria were reported. The patient underwent lab tests and procedures which included sars-cov-2 test: which resulted as covid post vaccination. The outcome of the events was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1646708
Sex: F
Age:
State: NJ

Vax Date: 08/06/2021
Onset Date: 08/08/2021
Rec V Date: 08/28/2021
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: I am breastfeeding; I am breastfeeding; I received the vaccine Friday evening and continued to pump regularly since then and within 36 hours got my period; I received the vaccine Friday evening and continued to pump regularly since then and within 36 hours got my period; This is a spontaneous report from a contactable consumer (patient herself). A 37-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number and expiration date was not reported) via an unspecified route of administration, administered in Arm Left on 06Aug2021 18:00 (at age of as 37-years-old) DOSE 1, SINGLE for COVID-19 immunization. Patient was not pregnant at the time of vaccination. Patient's medical history and concomitant medications were not reported. Patient had not known allergies. Other medical history was reported as None. 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. It was reported that, on 08Aug2021 14:45 the patient was breastfeeding and she had been for 8 months and have not had menstrual cycle this whole time. Patient received the vaccine Friday evening and continued to pump regularly since then and within 36 hours got period. Patient did not receive any treatment for AEs. Since the vaccination, the patient had not been tested for COVID-19. Outcome of event I received the vaccine Friday evening and continued to pump regularly since then and within 36 hours got my period was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101015626 maternal case/Child case

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am