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
46,870MODERNA
532GLAXOSMITHKLINE BIOLOGICALS
353PFIZER\BIONTECH
231MERCK & CO. INC.
221UNKNOWN MANUFACTURER
62SEQIRUS, INC.
25DYNAVAX TECHNOLOGIES CORPORATION
13EMERGENT BIOSOLUTIONS
12SANOFI PASTEUR
9NOVARTIS VACCINES AND DIAGNOSTICS
5PFIZER\WYETH
5PAXVAX
2TEVA PHARMACEUTICALS
2PROTEIN SCIENCES CORPORATION
1BERNA BIOTECH, LTD.
1INTERCELL AG
1CSL LIMITED

COVID19 Lot Number

VAX LOT Total
2S9CL1,906
1,575
289
IMM209286
252
236
229
s029456178
171
UT7065MA166
155
149
145
S034636133
107
U62828AA103
100
98
P10025327596
U6737AA85
UJ446AA79
78
78
59
57
4BH3254
4F47253
52
27656352
50
PP9L548
49TM346
42
40
38
MENVEO38
4F47237
R1B252M36
34
C5763AA30
93362229
25
300057A24
UNK24
22
CW311621
18
17
15
UH894AB15
3Y7NL12
R1B743M12
EJ168611
el128410
10
10
10
9
ARBA141A9
UNK9
8
UNK8
8
1F4EB8
Unknown7
7
No batch number6
5
5
UJ090AA5
5
5
4
4
4
UNK4
JEV18K95E4
UNK3
A115A3
Z127A3
3
3333324181073
2
2
2
TAR352
1
1
1
1
1
A739081
1
1
1
1
1
037K20A68,542
EL128447,700
133

Incidents per State

State Total
15,185
CA14,096
NY7,507
TX7,196
FL6,939
IN5,527
PA4,560
IL4,179
OH4,054
AZ3,856
MI3,771
NJ3,411
MA3,278
VA3,208
NC3,114
WA3,034
GA2,864
MD2,652
MN2,534
CO2,532
WI2,457
MO2,029
OR1,943
TN1,715
CT1,693
KY1,603
OK1,226
AL1,201
KS1,162
IA1,157
SC1,106
NM1,065
UT973
AR951
LA945
NE829
NV797
ME795
MT789
NH756
ID674
AK661
WV661
PR650
MS585
HI536
RI510
VT441
SD361
ND356
DE350
DC239
WY209
GU32
AS16
VI13
MP9
MH3
FM2
QM1
XB1

ID: 0976734
Sex: M
Age:
State:

Vax Date: 12/28/2020
Onset Date: 12/28/2020
Rec V Date: 01/27/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Large rash around the injection site; This is a spontaneous report from a contactable physician (patient). A 31-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140), intramuscular (left arm) on 28Dec2020 19:00 at single dose for Covid-19 immunization. There was no medical history; no known allergies. The patient's concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 28Dec2020, the patient experienced large rash around the injection site which lasted 7 days. There was no treatment received for the adverse event. The outcome of event was recovered on 04Jan2021. The patient has not been tested for COVID-19 since the vaccination.

Other Meds:

Current Illness:

ID: 0976735
Sex: F
Age:
State: MI

Vax Date: 01/11/2021
Onset Date: 01/12/2021
Rec V Date: 01/27/2021
Hospital:

Lab Data: Test Date: 202101; Test Name: bottom number; Result Unstructured Data: Test Result:53; Comments: bottom number went up to 53; Test Date: 20210111; Test Name: Blood pressure; Result Unstructured Data: Test Result:133/80; Test Date: 20210113; Test Name: Blood pressure; Result Unstructured Data: Test Result:93/50; Test Date: 20210113; Test Name: Blood pressure; Result Unstructured Data: Test Result:87/56; Test Date: 20210113; Test Name: Blood pressure; Result Unstructured Data: Test Result:90/50; Test Date: 202101; Test Name: Blood pressure; Result Unstructured Data: Test Result:133/70; Comments: normal; Test Date: 202101; Test Name: Blood pressure; Result Unstructured Data: Test Result:133/90; Comments: normal

Allergies:

Symptoms: fever; severe chills/could not get warm; her breathing was deep; drop in blood pressure; mild swelling/Swelling of Left Arm; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EK9231) via an unspecified route of administration in the left arm on 11Jan2021 10:00 at a single dose for COVID-19 vaccine (because she's 74 and high risk). Medical history included hypertension. Concomitant medication included irbesartan oral (by mouth) from an unspecified date (maybe 3 years ago) and ongoing at 300 mg once daily (150mg, 2 tablets once a day in the morning) for hypertension as blood pressure medication. The patient received the first dose of vaccine on Monday (11Jan2021) morning (AM) at 10 at the county (public) health department. She had no problem at all until yesterday Tuesday, she experienced mild swelling; the swelling happened in the upper left arm (swelling of left arm) which started on 12Jan2021, this was also the same side that she got her vaccine on, the left arm. On 13Jan2021 she woke up at 4AM [also reported as thirty (30) hours after the shot] in which she started to have severe chills (horrendous chills), could not get warm under the blanket for an hour and a half. It lasted a long time. Her severe chills did stop, she used an electric (heated) blanket. This morning on 13Jan2021 at 8:30, she woke up with the fever, which she was able to reduce with acetaminophen (did take two acetaminophen). Her fever was also gone. She was a little concerned because she thought her breathing was deep too on 13Jan2021. She did some relaxing breathing which helped. It lasted a long time. The patient also experienced a drop in blood pressure on 13Jan2021. Her blood pressure has been running the past few days at 133/80 on 11Jan2021. Today (13Jan2021), she took her blood pressure and it was at 93/50. It went to 87/56 after drinking some salty soup on 13Jan2021 (the bottom number in the blood pressure was going up a little, and the top number was going down a little). Her blood pressure has been normal 133/70 on Jan2021, but this morning it was 90/50 on 13Jan2021. Her blood pressure has been running normal the last couple of days like 133/90 on Jan2021. She was shocked it was lower. She knew they talk about dizziness and weakness, but she didn't experience that. She was concerned about that sudden drop in blood pressure. She did some research and started eating some salty soup and stuff (has been drinking salty soup). Her bottom number went up to 53 on Jan2021. She was concerned about that drop there. She was wondering if that was a side effect of the vaccine (result of the vaccine). She asked if drop in blood pressure was a concern. She had no positive test for Covid before the vaccine. She never had any tested, she's been pretty isolated. She had no antibody test. She has had no issues with vaccine in the past. Therapeutic measures were taken as a result of severe chills/could not get warm, fever, her breathing was deep, and drop in blood pressure. The outcome of swelling of left arm/mild swelling and drop in blood pressure was not recovered; of severe chills/could not get warm was recovered on 13Jan2021 05:30 and fever was recovered on 13Jan2021; and of her breathing was deep was recovering.

Other Meds: IRBESARTAN

Current Illness:

ID: 0976736
Sex: M
Age:
State: NY

Vax Date: 01/11/2021
Onset Date: 01/01/2021
Rec V Date: 01/27/2021
Hospital:

Lab Data: Test Date: 20210112; Test Name: Temperature; Result Unstructured Data: Test Result:102.1 Fahrenheit; Test Date: 20210113; Test Name: Temperature; Result Unstructured Data: Test Result:one hundred and something Fahrenheit

Allergies:

Symptoms: he had 102.1 temp; he started not feeling well; chills; ringing in ears/ The ringing was in both ears; body aches; joint aches; fatigue; lymphadenopathy/had swollen lymph nodes like the size of an apple; he was uncomfortable; His eyes were also hurting; The light bothered his eyes; This is a spontaneous report from a contactable Other HCP (patient) and a contactable Nurse (patient's wife). A 51-year-old male patient received the 2nd dose of bnt162b2 (BNT162B2, Batch/lot # EL3246, Expiry Date Apr2021) at single dose at left arm on 11Jan2021 18:00 for Covid-19 immunisation, administered at hospital as being a certified registered nurse anesthetist (CRNA). The patient medical history was none. There were no concomitant medications. The patient received the 1st dose of bnt162b2 (BNT162B2, lot # EK5730, expiry: 31Mar2021) at single dose at left arm on 23Dec2020 for Covid-19 immunisation and he has been fine, no adverse effect occurred. No additional vaccines administered on same date of BNT162B2. The patient experienced lymphadenopathy which is a size of tennis ball under my left armpit /had swollen lymph nodes like the size of an apple in his left arm in the axillary area, where he received the vaccine on 12Jan2021, he started not feeling well on 12Jan2021 around 9.00, he had 102.1 temp Fahrenheit on 12Jan2021 17:00, chills on 12Jan2021, ringing in ears/ the ringing was in both ears on 12Jan2021, body aches on 12Jan2021, joint aches on 12Jan2021, fatigue on 12Jan2021, his eyes were also hurting on an unspecified date in Jan2021, the light bothered his eyes on an unspecified date in Jan2021. The patient underwent lab tests and procedures which included body temperature: 102.1 fahrenheit on 12Jan2021, he was uncomfortable on 12Jan2021, body temperature: 100 and something fahrenheit on 13Jan2021. The outcome of lymphadenopathy/had swollen lymph nodes like the size of an apple was worsened, of he had 102.1 temp, ringing in ears/ the ringing was in both ears was not recovered, he started not feeling well, his eyes were also hurting, light bothered his eyes was unknown, chills, body aches, joint aches, fatigue was recovered on 13Jan2021. Course of events: Around 9AM on 12Jan2021 he started not feeling well. By the time he got home from work he had 102.1 temp Fahrenheit around 5PM. Temp was ongoing. His eyes were also hurting. The light bothered his eyes. He can't put his arm down. His left arm in the axillary area, where he received the vaccine, had swollen lymph nodes like the size of an apple. He had chills, ringing in ears, body aches and joint aches, and fatigue 12Jan2021. He was uncomfortable. The ringing was in both ears. On 13Jan2021 his temp was one hundred and something. What is concerning was the swelling in the armpit in the arm he received the vaccine in. It was very painful. It was starting to radiate up his arm. He did not go to the doctor, since he was relatively healthy. No event required a visit to Emergency Room or Physician Office. The reporting Nurse assessed the events he had 102.1 temp, His left arm in the axillary area, where he received the vaccine, had swollen lymph nodes like the size of an apple as serious as medically significant. The reporting Nurse assessed the events he had 102.1 temp, His left arm in the axillary area, where he received the vaccine, had swollen lymph nodes like the size of an apple, chills, Ringing in ears, body aches and joint aches, and Fatigue as related to BNT162B2.; Sender's Comments: Based on a compatible temporal association and known product safety profile, causality between events lymphadenopathy and fever and BNT162B2 COVID-19 vaccine 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: 0976737
Sex: F
Age:
State: CA

Vax Date: 01/12/2021
Onset Date: 01/13/2021
Rec V Date: 01/27/2021
Hospital:

Lab Data: Test Date: 20210113; Test Name: fever; Result Unstructured Data: Test Result:101.4; Comments: fever

Allergies:

Symptoms: fever 101.4; This is a spontaneous report from a contactable other healthcare professional (patient). A 54-year-old female patient started to receive second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EL1284), intramuscular on 12Jan2021 12:00 PM at single dose on the left arm for COVID-19 immunization. The patient is not pregnant. The patient has no known drug allergies (NKDA). There were no medical history and concomitant medications. No other vaccines in four weeks and no other medications in two weeks. No COVID prior vaccination. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EJ1685) intramuscular on 22Dec2020 12:00 PM on the left arm. Facility type vaccine was hospital. On 13Jan2021 12:00 PM, the patient experienced fever 101.4. No treatment for the event. Outcome of the event was recovered in Jan2021. Patient was not tested for COVID post vaccination.

Other Meds:

Current Illness:

ID: 0976738
Sex: F
Age:
State: WA

Vax Date: 01/04/2021
Onset Date: 01/12/2021
Rec V Date: 01/27/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Delayed allergic reaction at injection site - red, raised, hard, warm to touch, and itchy. Not painful.; red; raised, hard; warm to touch; itchy; This is a spontaneous report from a contactable other health professional (HCP). A 41-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), via an unspecified route of administration on arm left on 04Jan2021 at a single dose for COVID-19 immunization. Medical history included obesity and known allergies to penicillin, both from an unknown date and unknown if ongoing. Concomitant medication included phentermine. The patient experienced a delayed allergic reaction at injection site - red, raised, hard, warm to touch, and itchy, not painful on 12Jan2021. Therapeutic measures were taken as a result of delayed allergic reaction at injection site - red, raised, hard, warm to touch, and itchy. The outcome of the events was recovering.

Other Meds: PHENTERMINE

Current Illness:

ID: 0976739
Sex: F
Age:
State: NC

Vax Date: 01/11/2021
Onset Date: 01/12/2021
Rec V Date: 01/27/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Severe rigors involving core and extremities, making it difficult to breathe.; Severe rigors involving core and extremities, making it difficult to breathe.; muscle pain; joint pain noted in hips; loss of appetite; profound fatigue; This is a spontaneous report from a non-contactable nurse (patient). A 31-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot: EK9231, expiry: unknown), via an unspecified route of administration on 11Jan2021 11:45 on the left arm at a single dose for COVID-19 immunization. The patient received the vaccine in a hospital. The patient had no other vaccine in four weeks. Medical history included clinical depression. The patient has no known allergies. The patient was not tested for COVID prior and post vaccination. Concomitant medications included bupropion and multivitamin. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot: EK5730, expiry: unknown) on 21Dec2020 at 11:00 in the right arm for COVID-19 immunization. On 12Jan2021 at 01:00, the patient experienced severe rigors involving core and extremities, making it difficult to breathe. Flexeril 10 mg was taken to help relieve rigors. Rigors stopped and ease of breathing resumed in 1 hour. Other symptoms include muscle pain, joint pain noted in hips, loss of appetite, and profound fatigue x48 hrs. The events difficult breathing, muscle pain, joint pain noted in hips, loss of appetite and profound fatigue were not treated. The outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the compatible temporal association, the vaccination with BNT162B2 might play a contributory role in triggering the onset of "severe rigors involving core and extremities, making it difficult to breathe". 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: BUPROPION

Current Illness:

ID: 0976740
Sex: F
Age:
State: IL

Vax Date: 01/11/2021
Onset Date: 01/12/2021
Rec V Date: 01/27/2021
Hospital:

Lab Data:

Allergies:

Symptoms: maculopapular rash on abdomen; redness covering trunk and extremities, sparing head, hands, and feet; This is a spontaneous report from a contactable healthcare professional (patient). A 58-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL246 and expiry date: unknown), via an unspecified route of administration, left arm on 11Jan2021 09:45 at a single dose for COVID-19 immunization. The first dose was received on 21Dec2020 10:30 (lot number: EJ1685) on the left arm. Medical history included mild asthma GERD (gastrooesophageal reflux disease, and allergies to certain antibiotics causing a rash. Patient was not pregnant. Concomitant medication included montelukast sodium, omeprazole, and colecalciferol (VITAMIN D). The adverse events began as maculopapular rash on abdomen now redness covering trunk and extremities, sparing head, hands, and feet on 12Jan2021. Outcome of the events was not recovered. No treatment for the events was received. Patient was not diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination.

Other Meds: MONTELUKAST SODIUM; OMEPRAZOLE; VITAMIN D [COLECALCIFEROL]

Current Illness:

ID: 0976741
Sex: M
Age:
State:

Vax Date: 12/29/2020
Onset Date: 12/31/2020
Rec V Date: 01/27/2021
Hospital:

Lab Data: Test Date: 20201231; Test Name: COVID-19; Test Result: Positive

Allergies:

Symptoms: He mentioned that he took the first dose of the COVID-19 vaccine on 29Dec2020. Then, after a few days, tested positive for COVID-19.; He mentioned that he took the first dose of the COVID-19 vaccine on 29Dec2020. Then, after a few days, tested positive for COVID-19.; This is a spontaneous report from a Pfizer-sponsored program, Pfizer First Connect. A contactable nurse (patient) reported that a male patient of an unspecified age received first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; lot/batch number and expiry date were unknown), via an unspecified route of administration on 29Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. He mentioned that he took the first dose of the COVID-19 vaccine on 29Dec2020. Then, after a few days, tested positive for COVID-19. He is scheduled for his second dose this weekend (16Jan2021-17Jan2021). He wants more information about his safety. What happens next, the do's and don'ts. He is asking if there is any information on this. The outcome of the event was unknown. Information about the lot/batch number has been requested.; Sender's Comments: Based on the information currently available, lack of efficacy of the suspected vaccine BNT162B2 cannot be completely excluded. However, individuals may not be protected until at least 7 days after their second dose of the vaccine. It is unlikely that the patient would have fully developed immunity due to the very short time lag between the first vaccine dose and the event onset.

Other Meds:

Current Illness:

ID: 0976742
Sex: F
Age:
State:

Vax Date: 01/12/2021
Onset Date: 01/01/2021
Rec V Date: 01/27/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Paratrex to kill of parasites; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received her first dose of bnt162b2 (BNT162B2 reported as PFIZER-BIONTECH COVID-19 VACCINE; unknown lot number and expiration date), via an unspecified route of administration on 12Jan2021 at a single dose for covid-19 immunization. The patient medical history was not reported. Concomitant medication included bismuth subsalicylate, calcium carbonate (PEPTO BISMOL). The patient reported that she and her husband got the vaccination yesterday (12Jan2021) and she was taking Paratrex to kill of parasites. She was also taking Pepto Bismol. The patient inquired if this will interfere with the vaccine. The outcome of the event was unknown. The following information on the batch/lot number has been requested

Other Meds: PEPTO BISMOL [BISMUTH SUBSALICYLATE;CALCIUM CARBONATE]

Current Illness:

ID: 0976743
Sex: F
Age:
State:

Vax Date: 01/12/2021
Onset Date:
Rec V Date: 01/27/2021
Hospital:

Lab Data:

Allergies:

Symptoms: fever; dizziness; head hurts feeling like it is going to split/headache; medicine taste in her mouth; aches all over; This is a spontaneous report from a contactable consumer (patient) via the Medical Information Team. This consumer reported same events for different patients. This is the first of two reports. A female patient of unspecified age (reported as 56 [units unspecified]) received her second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; unknown lot number and expiration date), via an unspecified route of administration on 12Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; unknown lot number and expiration date), via an unknown route of administration on unknown date at a single dose for COVID-19 immunization. The patient reported that she got her second vaccine and her friend got the vaccine same day and her friend was feeling the same way as the reporter was feeling: had fever, dizziness, headache (also reported as head hurts feeling like it is going to split), aches all over, medicine taste in her mouth, and has been in bed all day; all on unspecified dates. The patient reported that she has taken acetaminophen (TYLENOL) but no diphenhydramine (BENADRYL). The outcome of the events was unknown. The following information on the batch/lot number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021031286 same reporter/drug/events, different patient

Other Meds:

Current Illness:

ID: 0976744
Sex: F
Age:
State:

Vax Date: 12/28/2020
Onset Date: 01/01/2021
Rec V Date: 01/27/2021
Hospital:

Lab Data: Test Date: 202101; Test Name: Covid test; Result Unstructured Data: Test Result:positive

Allergies:

Symptoms: tested positive COVID-19; tested positive COVID-19; This is a spontaneous report from a contactable healthcare professional, reporting for herself. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on 28Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient received first dose of the COVID-19 vaccine on 28Dec2020, 9 days later tested positive COVID-19. She requested information on the recommendations for getting her second dose of the vaccine. The patient underwent lab tests and procedures which included Covid test: positive on Jan2021. The outcome of the events was unknown. Information on the batch/lot number has been requested.; Sender's Comments: Comirnaty's effectiveness is documented after 7 days from the second dose

Other Meds:

Current Illness:

ID: 0976745
Sex: M
Age:
State:

Vax Date: 01/01/2021
Onset Date: 01/01/2021
Rec V Date: 01/27/2021
Hospital:

Lab Data:

Allergies:

Symptoms: His nose has been dripping; This is a spontaneous report from a contactable consumer, reporting for himself. A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date in Jan2021 at a single dose for COVID-19 immunization. Medical history included allergy from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient had his COVID-19 vaccine three days ago and since then his nose has been dripping. He wanted to know why he was not allowed to take his allergy test. He also said that he thinks his allergy is to cortisone but was not that serious. He was going to the doctor to get a cortisone shot and he wanted to know if he was able to do that or not. He said it was an allergy shot, he guessed it was going to be cortisone, but he doesn't know for sure he just knows it was an allergy shot. He says he was supposed to get his second shot 31Jan2021, so he was trying to see if he has enough time in between to take his allergy shot. He was going to go as soon as he can to go get the allergy shot, he thinks it will be plenty of time because his second shot should be the 31Jan2021. No, he does not have time he was not sick he just doesn't want it to get worse and he just does wants to know if he can take the allergy shot. If not, it was fine, but he wants to know if it was alright to take it. He just wanted to know if he can take the allergy shot or not. The outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 0976747
Sex: F
Age:
State:

Vax Date: 01/12/2021
Onset Date:
Rec V Date: 01/27/2021
Hospital:

Lab Data: Test Name: temperature; Result Unstructured Data: Test Result:99.0; Test Name: temperature; Result Unstructured Data: Test Result:98.1.

Allergies:

Symptoms: his mother's temperature rise to 98.1/ she had temperature of 99.0; headache; chills; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date unspecified), via an unspecified route of administration on 12Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Consumer said he was calling for his mother who received the 1st dose of the Covid-19 Vaccine. He said that after receiving the vaccine, his mother's temperature rose to 98.1 and also experienced headache and chills on an unspecified date. Consumer wants to know if these side effects have been reported. Today, he was looking at pamphlet that they gave her when she got the shot. She called them and they said they had to look for the # number. He sees on here that there may be injection site pain tenderness, muscle pain, joint pain, fever and chills. He says right now, she had temperature of 99.0 and she took Aspirin or Tylenol at 12. He says he was just checking on her health to make sure what do they do. She also said she had a headache and she took Aspirin. He clarified that she took Tylenol, she did not take Aspirin. He has been hearing if there were side effects to just rest. She was saying she had some chills and she took Tylenol 325 mg. He says he would have thought that the hospital where she got the vaccine would have explained to them what to do if she experienced anything but he was thinking that this was just side effects. He asks if he should just call the physician talk with them. He would like to know how often these side effects have been reported with the vaccine. He pretty much understands the process, he was just looking out for his mom and just wanted to know if she needs to go into the hospital or if she was fine. Outcome of events was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 0976748
Sex: M
Age:
State: MD

Vax Date: 01/11/2021
Onset Date: 01/12/2021
Rec V Date: 01/27/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Shivering; muscle cramps; Extreme Neck and back pain; Extreme Neck and back pain; Left armpit pain with tinglingly sensation down left arm; Left armpit pain with tinglingly sensation down left arm; This is a spontaneous report from a contactable nurse. A 26-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EL1283, expiry date not reported), via an unspecified route of administration on 11Jan2021 at a single dose in the left arm for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient had no COVID prior to vaccination. The patient had no other vaccine in four weeks. The patient had the first dose of bnt162b2 (brand: Pfizer, lot number: Ej1685, expiry date not reported) on 21Dec2020, intramuscular in the left arm for COVID 19 immunization. On 12Jan2021, patient experienced shivering and muscle cramps the first day; extreme neck and back pain x2 days post injection. On third day post injection, patient experienced left armpit pain with tinglingly sensation down left arm. No treatments received in response to the events reported. The patient was not tested for COVID post vaccination. The outcome of the events shivering, muscle cramps, extreme neck and back pain and left armpit pain with tinglingly sensation down left arm was unknown.

Other Meds:

Current Illness:

ID: 0976749
Sex: F
Age:
State: GA

Vax Date: 01/11/2021
Onset Date: 01/11/2021
Rec V Date: 01/27/2021
Hospital:

Lab Data: Test Date: 20210111; Test Name: heart beat; Result Unstructured Data: Test Result:Erratic heart beat

Allergies:

Symptoms: Erratic heart beat; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: lot number: Elo140), via an unspecified route of administration on left arm on 11Jan2021 13:00 (first dose) at a single dose for COVID-19 immunization. The patient medical history was not reported. The patient is not pregnant at the time of vaccination. No other vaccine in four weeks. Patient had no COVID prior vaccination and no known allergies. Concomitant medications included other medication (taken other medication in two weeks). The patient experienced erratic heart beat on 11Jan2021 14:00. The event resulted in doctor or other healthcare professional office/clinic visit. There was no treatment for the event. The patient was not COVID tested post vaccination. The outcome of the event was not recovered.

Other Meds:

Current Illness:

ID: 0976750
Sex: F
Age:
State: FL

Vax Date: 01/13/2021
Onset Date: 01/13/2021
Rec V Date: 01/27/2021
Hospital:

Lab Data:

Allergies:

Symptoms: there was a little sensation but it may have been in her head; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number, expiration date unknown) , via an unspecified route of administration in her arm on 13Jan2021 at a single dose for COVID-19 immunisation . The patient's medical history and concomitant medications were not reported. On 13Jan2021, the patient reported that she received the COVID vaccine today and did not feel a thing, she did not feel the needle or the shot. She said other people have sore arm so she wanted to check if she should be feeling anything. She said she removed the bandaid to see the needle puncture but she did not see it. She felt like the nurse didn't give it to her in her arm. Her arm is not sore. She had to wait 15 minutes after she got the vaccine. There was a little sensation from it but maybe it was in her head on 13Jan2021. The nurse pinched her arm when she gave it. The patient stated her next dose is scheduled on 03Feb2021. The outcome of the event was unknown. Information on Lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 0976751
Sex: F
Age:
State: GA

Vax Date: 01/08/2021
Onset Date: 01/08/2021
Rec V Date: 01/27/2021
Hospital:

Lab Data:

Allergies:

Symptoms: severe arthralgias; migraine headache; mild nausea; This is a spontaneous report from a contactable nurse. A 59-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EL0142/expiration date unknown) dose number 2, via an unspecified route of administration on 08Jan2021 09:00 at a single dose on the right arm for COVID-19 immunization. The patient received the vaccine in a hospital. Medical history included asthma, arrhythmia, sulfonamide allergy, and latex allergy. The patient was not diagnosed with COVID prior vaccination and was not tested for COVID post vaccination. Historical vaccine included BNT162B2 (COVID-19, lot number EJ1685, dose number 1) on 18Dec2020 06:30 on the right arm. There were no other vaccinations within 4 weeks. Concomitant medications included ASA, acetylsalicylic acid, caffeine, paracetamol, salicylamide (EXCEDRIN), cyanocobalamin (VIT B12), ergocalciferol (VIT D), and cetirizine hydrochloride (ZYRTEK). The patient experienced severe arthralgias, migraine headache, and mild nausea on 08Jan2021 20:00. The outcome of the events was recovered in Jan2021.

Other Meds: ASA; EXCEDRIN [ACETYLSALICYLIC ACID;CAFFEINE;PARACETAMOL;SALICYLAMIDE]; VIT B12; VIT D; ZYRTEK

Current Illness:

ID: 0976752
Sex: F
Age:
State: PA

Vax Date: 01/11/2021
Onset Date: 01/12/2021
Rec V Date: 01/27/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Muscle pain; Joint pain; Headache; This is a spontaneous report from a non-contactable other health care professional. A 46-year-old female patient received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: EL3246), via an unspecified route of administration on 11Jan2021 at SINGLE DOSE at left arm for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received first dose of COVID19 vaccine bnt162b2 for COVID-19 immunization on 21Dec2020; lot number: EL0140 on left arm at 46 years old. On 12Jan2021, the patient experienced muscle pain, joint pain, and headache. The patient did not receive treatment for the events. The outcome of the events was unknown. No follow up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 0976753
Sex: M
Age:
State: NJ

Vax Date: 01/12/2021
Onset Date: 01/13/2021
Rec V Date: 01/27/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Left arm pain at rest and with movement; headache; full body myalgias; sore throat; This is a spontaneous report from a contactable physician (patient). A 33-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK9231 expiration date unknown), intramuscular in left arm on 12Jan2021 at 08:00 at a single dose for COVID-19 immunization. Medical historywas reported as none. The patient had no known allergies. The patient's concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EH9899) on 22Dec2020 at 12:30 PM for COVID-19 immunization. The patient has not had COVID prior to vaccination. The patient had no other vaccines within four weeks. On 13Jan2021 at 14:00, the patient experienced left arm pain at rest and with movement, headache, full body myalgias, and sore throat. Therapeutic measures were taken as a result of the events and included treatment with ibuprofen. The patient was not tested for COVID post vaccination. The outcome of the events was recovering.

Other Meds:

Current Illness:

ID: 0976754
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 01/27/2021
Hospital:

Lab Data:

Allergies:

Symptoms: migraine; This is a spontaneous report from a contactable consumer. An adult male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date unspecified), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced migraine that has lasted for almost one week since receiving the vaccine. The reporter did not know if the vaccine that the patient received was from Pfizer or Moderna. Outcome of event was unknown. Information on lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 0976755
Sex: F
Age:
State: CA

Vax Date: 01/13/2021
Onset Date: 01/13/2021
Rec V Date: 01/27/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Fatigue; Chills; Brain fog; Headache; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided), via an unspecified route of administration (left arm) on 13Jan2021 16:15 at single dose for covid-19 immunisation. There were no medical history and concomitant medications. On 13Jan2021 17:45, the patient experienced Fatigue, chills, brain fog, headache. No treatment was given for the events. The outcome of the events was recovering. The patient has no Covid prior vaccination and was not tested post vaccination. Information on the Batch/Lot number has been requested.

Other Meds:

Current Illness:

ID: 0976756
Sex: F
Age:
State: WI

Vax Date: 01/12/2021
Onset Date: 01/13/2021
Rec V Date: 01/27/2021
Hospital:

Lab Data: Test Date: 20210113; Test Name: fever; Result Unstructured Data: Test Result:low

Allergies:

Symptoms: chills; achy back; low fever; injection site pain; This is a spontaneous report from a contactable other health care professional. A 59-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number el 3248 and expiration date not provided), intramuscular (right arm) first dose on 12Jan2021 12:00 at single dose for covid-19 immunisation. The patient's medical history included psoriasis, seasonal allergies, and If COVID prior vaccination: Yes. The patient's concomitant medication included oxymetazoline hydrochloride (CLARITIN EYE ALLERGY RELIEF), ergocalciferol (VIT D), vitamin c [ascorbic acid], and zinc. On 13Jan2021 07:00, the patient experienced chills, achy back, low fever, injection site pain. No treatment was given to the events. The outcome of the events was not recovered. No other vaccine was taken within four weeks and not tested for Covid post vaccination.

Other Meds: CLARITIN EYE ALLERGY RELIEF; VIT D; VITAMIN C [ASCORBIC ACID]; ZINC

Current Illness:

ID: 0976757
Sex: F
Age:
State:

Vax Date: 12/23/2020
Onset Date: 01/01/2021
Rec V Date: 01/27/2021
Hospital:

Lab Data: Test Date: 20210101; Test Name: COVID; Test Result: Positive ; Test Date: 20210113; Test Name: COVID; Test Result: Positive ; Comments: also added testing positive to COVID today

Allergies:

Symptoms: first dose of the COVID-19 vaccine on 23Dec2020, and testing positive to COVID on 01Jan2021; first dose of the COVID-19 vaccine on 23Dec2020, and testing positive to COVID on 01Jan2021; This is a spontaneous report from a non-contactable Other HCP. A 61-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration on 23Dec2020 at a single dose for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient received the first dose of the COVID-19 vaccine on 23Dec2020, and testing positive to COVID on 01Jan2021. She mentioned that her "last recorded symptoms" were on 06Jan2021 and has been "symptom less" for 8 days, now. She specified that her second dose was due today but she didn't receive it at her workplace, as planned (due to isolation measures). She asked what was the allowed window to receive the second dose of the vaccine? She also asked what were the criteria to receive the second dose, after testing positive. She then asked if she would need to repeat the vaccination series. Patient also mentioned testing positive to COVID on 13Jan2021. The outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on the mechanism of action of BNT162B2 vaccine, it is unlikely the patient would have fully developed immunity for the vaccine to be effective, due to the number of days passed since the vaccine was given. However, a causal relationship between event "first dose of the COVID-19 vaccine on 23Dec2020, and testing positive to COVID on 01Jan2021" (coded to Drug ineffective / SARS-CoV-2 test positive) and BNT162B2 vaccine cannot be completely excluded.

Other Meds:

Current Illness:

ID: 0976758
Sex: F
Age:
State: CA

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

Lab Data: Test Name: COVID tests; Test Result: Negative

Allergies:

Symptoms: like an anaphylactic reaction but not in her throat; itching and inflammation, in eyes as well/eyes were swollen and itchy; itching and inflammation, in eyes as well; swelling on her eyes and itching on her eye lids; swelling on her eyes and itching on her eye lids; welts; whelps on her hip, inflamed and itchy/general arthritis symptoms; Headache dull; shingle like rash on tailbone, genital area / raised itchy rash on the tailbone like shingles; itching on her face that she couldn't see / raised itchy area on her left cheek and eyes; rash / rash down her thighs/rash that was across her body; rash vulva; swelling / vulva was swollen; itching / itching around the genital area, vulva; itching / itching around the genital area, vulva; This is a spontaneous report from a Pfizer-sponsored program. A contactable Nurse (patient) worked in outpatient mental health reported that a 60-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284, Expiry Date: Apr2021) via an unspecified route of administration on 04Jan2021 at 16:20 in the left arm at single dose for COVID-19 vaccination. Vaccine administered at hospital and not military facility. No additional vaccines administered on same date of the Pfizer suspect. Medical history included ongoing Graves' disease (the patient had her thyroid irradiated away for Grave's disease 25 years ago). Family Medical History was none. Concomitant medication included ongoing levothyroxine 1.25 mcg once daily by mouth Graves' disease taking for 25 years. Prior vaccination within 4 weeks was none. The patient received her Pfizer COVID 19 vaccine on 04Jan2021. Since then she started to experience a genital itch immediately; a rash that was across her body; eyes were swollen and itchy; new itchy rash 13Jan2021. She felt okay going home then she started to have itching around the genital area. She thought she might have a yeast infection but she didn't have any other symptoms for a yeast infection. Her vulva became swollen from 05Jan2021 and itchy from 04Jan2021 and she noticed rash around her body. It all started in the genital area. The next day the rash spread down her thighs and she noticed an itchy place on her face, but you couldn't see it. Her thighs were inflamed and she noticed patches of angry whelps on her hips as well as a itchy rash area on her tailbone that seemed more like shingles; size of a quarter; raised, itchy, rash, that felt like it was radiating out. Then she noticed the rash on her face on her cheek, general swelling on her eyes and itching on her eye lids. Now the genital itching was less and most of her symptoms were improved but her eye was driving her crazy and it was more swollen on the outside. She tried to treat her eyes with eye drops Dry Eye Relief (manufacturer Similasan; no UPC seen, lot number: 15942; expiration date: Sep2022, ingredients include Belladonna) but it didn't help. They were still itchy and weepy. The eye drops were not working. She also treated the rash and itching with Benadryl at night and it improved the symptoms overall. She took Tylenol (UPC 300043760; lot number: PMA003; expiration date: Aug2022) and Bayer Aspirin (81mg; lot number: NAA93E1; expiration date: Feb2023. No UPC code on bottle) every day for general arthritis symptoms, but they didn't touch her dull headache she has had on and off since the vaccine. Before she got the vaccine, she had a little tag on her vulva, it was tiny. Now after experiencing the itching, swelling, rash on her vulva, the tag was gone. It just took a layer of skin right off. It was not uncomfortable but the whole layer of the skin was gone. It was very uncomfortable while it was happening but now it was okay. When she noticed these symptoms, she tried to call occupational health and a institute but didn't get anyone. She also contacted her HCP but had not heard back. It seemed to her like a lot of side effects and a lot of itching. She didn't have it in her throat, but all that itching seems a lot like an anaphylactic reaction. She was curious whether we would recommend her to take the second dose since they say the reaction to the second dose was worse. She had multiple COVID tests that have all come back negative. A friend tested positive so she had a test; and she had a test when she traveled. The events did not require a visit to physician or emergency room. The patient had reactions: itching, rash, swelling, welts, shingle like rash on tailbone, genital area, hips moving to her face, itching and inflammation, in eyes as well. She wanted to know if the 2nd dose was recommended. It was "like an anaphylactic reaction but not in her throat." itching around the genital area, vulva started from 04Jan2021, vulva was swollen started from 05Jan2021; Rash vulva started from 06Jan2021 to 10Jan2021; rash down her thighs started from 07Jan2021; Raised itchy rash on the tailbone like shingles started from 06Jan2021, whelps on her hip, inflamed and itchy from 07Jan2021; itching on her face that she couldn't see started from 06Jan2021; raised itchy area on her left cheek and eyes started from 07Jan2021; Headache dull started from 06Jan2021. The events Headache dull, itching on her face that she couldn't see; whelps on her hip, inflamed and itchy and raised itchy rash on the tailbone like shingles were reported as non-serious by the reporter and other events were considered as medical significant by the reporter. Investigation assessment for the events was reported as No. The outcome of the event anaphylactic reaction, inflammation in eye, welts was unknown, outcome of the event Rash vulva was recovered on 10Jan2021; of Headache dull, swelling eye was not recovered, of other events was recovering.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of anaphylaxis cannot be excluded, considering the plausible temporal relationship and the known adverse event profile of the suspect product. Severe allergic reaction is the known risk for the product. 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: LEVOTHYROXINE

Current Illness: Graves' disease (Had her thyroid irradiated away for Grave's disease 25 years ago)

ID: 0976759
Sex: M
Age:
State: MO

Vax Date: 01/12/2021
Onset Date: 01/13/2021
Rec V Date: 01/27/2021
Hospital:

Lab Data:

Allergies:

Symptoms: chills; injection site soreness; fever; headache; fatigue; This is a spontaneous report from a non-contactable consumer. A 35-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EK4176, expiration date not reported) via an unspecified route of administration on the left arm on 12Jan2021 at a single dose for COVID-19 immunization. Medical history included hepatitis B and patient had tested positive for Covid in May2020 and had recovered. Concomitant medications included hepatitis B experimental medicine. On 13Jan2021, the patient experienced injection site soreness, chills, fever, headache, fatigue. No treatment was received for the events. Post vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Outcome of the events was not recovered. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 0976760
Sex: F
Age:
State: KS

Vax Date: 01/08/2021
Onset Date: 01/09/2021
Rec V Date: 01/27/2021
Hospital:

Lab Data:

Allergies:

Symptoms: slight headache; low grade fever and chills for approx 10 hours post injection; low grade fever and chills for approx 10 hours post injection; This is a spontaneous report from a contactable other healthcare professional (HCP). A 65-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EK9231), intramuscular on 08Jan2021 18:00 (reported as 06:00 PM) at single dose on the left arm for COVID-19 immunization. Patient is not pregnant. There were no other medical history. No known allergies. The patient's concomitant medications were not reported. No other vaccine in four weeks. Facility type vaccine was hospital. No COVID prior vaccination. The patient experienced slight headache, low grade fever and chills for approximately 10 hours post injection on 09Jan2021 02:00 PM. No treatment for the events. Outcome of the events was recovered in Jan2021. Patient was not tested for COVID post vaccination. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 0976761
Sex: M
Age:
State: CA

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

Lab Data:

Allergies:

Symptoms: Hives; itching; swelling of feet, hands; swelling of axilla, buttocks; redness on hips, worsening after 1 week after second dose; administration date: 17Dec2020 / administration date: 05Jan2021; fever; chills; fatigue; malaise; body aches; headache; tinnitus; This is a spontaneous report from a contactable nurse (patient). A 29-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK9231; expiry date: unknown) via an unspecified route of administration in the right arm, on 05Jan2021 at 16:00, at a single dose, for COVID-19 immunization. Relevant medical history included known allergies to poison ivy/ poison oak. Concomitant medications included finasteride. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK5730; expiry date: unknown) on 17Dec2020 at 14:00 in the left arm for COVID-19 immunization. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in the hospital. On 05Jan2021, at 20:00, after second dose, the patient experienced hives with itching and swelling of feet, hands, axilla, buttocks, redness on hips, worsening after 1 week after second dose. On an unspecified date in Jan2021, for a 3-day period after second dose, patient had fever, chills, fatigue, malaise, body aches, headache, tinnitus, all since resolved except hives worsening. The patient did not receive therapy for the events. Outcome of the event hives was not recovered, for event "administration date: 17Dec2020 / administration date: 05Jan2021" was unknown, while for the other events was recovered. The patient has not been tested for COVID-19 since vaccination.

Other Meds: FINASTERIDE

Current Illness:

ID: 0976762
Sex: F
Age:
State: IN

Vax Date: 12/30/2020
Onset Date: 01/08/2021
Rec V Date: 01/27/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Swollen lymph node on left side of neck that is oblong in shape, measuring 2.5in x 1.5in; This is a spontaneous report from a contactable consumer. A 38-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK9231, expiration date not reported), via an unspecified route of administration (reported: left arm), on 30Dec2020 at 20:30 at a single dose, for COVID-19 immunization. Medical history was not reported. Concomitant medication includes unspecified multivitamins. The patient experienced swollen lymph node on left side of neck that is oblong in shape, measuring 2.5in x 1.5in, on 08Jan2021 at 5 AM. The patient has not recovered from the event.

Other Meds:

Current Illness:

ID: 0976763
Sex: F
Age:
State: IN

Vax Date: 12/20/2020
Onset Date: 01/01/2021
Rec V Date: 01/27/2021
Hospital: Y

Lab Data: Test Date: 20210101; Test Name: eosinophils; Result Unstructured Data: Test Result:slight increase; Comments: 09:00 PM; Test Date: 20210101; Test Name: CRP; Result Unstructured Data: Test Result:slight increase; Comments: 09:00 PM; Test Date: 20210101; Test Name: platelets; Result Unstructured Data: Test Result:increase; Comments: 09:00 PM

Allergies:

Symptoms: 2 weeks after covid 19 vaccine, had severe multiple allergic reactions never experienced.; Suture reaction to surgical site; allergic flare up of previously healed and closed nerve block locations; slight increase in eosinophils, CRP; slight increase in eosinophils, CRP; increase in platelets; This is a spontaneous report from a contactable nurse (patient). A 29-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number Ek5t30), intramuscularly on 20Dec2020 12:00 at single dose for covid-19 immunization. Vaccine location was right arm and it was the first dose. Patient is not pregnant. The facility type vaccine was workplace clinic. Medical history included hypothyroidism from an unknown date. Patient was not diagnosed with COVID-19 prior to vaccination nor tested for COVID-19 since the vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. 2 weeks after COVID-19 vaccine on 01Jan2021 21:00, patient had severe multiple allergic reactions never experienced. Suture reaction to surgical site, allergic flare up of previously healed and closed nerve block locations, then later apparent full body reaction to Bactrim. At least 3 allergic reactions never experienced before with slight increase in eosinophils, CRP, and increase in platelets. Severe Suture rejection to extremely common sutures. The adverse events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization one day. Patient received IV methylprednisone, Benadryl, famotidine as treatment for the adverse events. The outcome of events was recovered in Jan2021. Known allergies included apparent Bactrim allergy, in spite of allergic symptoms starting 4 days prior to taking Bactrim.; Sender's Comments: Based on the information currently provided, the vaccination might trigger the onset of multiple allergic reactions accompanying with lab abnormalities, considering the plausible temporal relationship. Severe allergic reaction is the known risk for the product. 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: 0976764
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 01/27/2021
Hospital:

Lab Data:

Allergies:

Symptoms: rash on the arm where the vaccine was administered into; she said, "it looks blistery".; rash on the arm where the vaccine was administered into; she said, "it looks blistery".; This is a spontaneous report from a non-contactable other health professional. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), batch/lot number and expiry date not provided, via an unspecified route of administration on an unspecified date at a SINGLE DOSE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced rash on the arm where the vaccine was administered into; she said, "it looks blistery". The outcome of events was unknown. No follow up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 0976765
Sex: F
Age:
State: WA

Vax Date:
Onset Date:
Rec V Date: 01/27/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Fatigue/Tiredness/I was tired that I could hardly get out the bed the next day; Nausea; Headache; Muscle paining; Chills; Feeling unwell; upset stomach; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), both intramuscular on an unspecified date (three weeks apart) at single dose (0.3 mL) for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient wanted to know if the reaction to the vaccine after the second dose is expected to be the same than as for the first dose. She also wanted to know if the second dose of the vaccine is stronger or the same as the first dose of the Pfizer BioNtech Covid 19 vaccine. She also wanted to know if your immune system is compromised because of a heart transplant should you receive the Pfizer-BioNtech Covid-19 vaccine or follow your HCP recommendations if they know this information. The patient experienced fatigue and nausea after her first dose of the COVID Vaccine. It was further reported that "It was the Pfizer vaccine for virus (further not clarified hence, captured as Unspecified vaccine" (pending clarification). The patient reacted but not seriously, she had most of the symptoms like upset stomach, tiredness. She didn't have the injection site pain, she was tired that she could hardly get out the bed the next day and then headache, muscle paining, some chills and no fever and some nausea. Just kind of feeling unwell. And she was just wondering a little bit about the second dose that they get. She was asking if she reacted to this that way will she react even worse to the next one or do they know that. Unknown if treatment was given. Limited information was available over the call. The outcome of the events was unknown. No follow-up attempts are possible. Information about lot/batch number could not be requested. No further information is expected.

Other Meds:

Current Illness:

ID: 0976766
Sex: F
Age:
State: PA

Vax Date: 01/12/2021
Onset Date: 01/12/2021
Rec V Date: 01/27/2021
Hospital:

Lab Data: Test Date: 20201119; Test Name: Nasal Swab; Test Result: Negative

Allergies:

Symptoms: headache; Right arm pain; fatigue; myalgia; This is a spontaneous report from a contactable healthcare professional (patient). A 38-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK9231), via an unspecified route of administration on right arm on 12Jan2021 08:30 (dose number 2) at a single dose for COVID-19 immunization. Medical history included allergic rhinitis. The patient was not pregnant at the time of vaccination. No other vaccine in four weeks and no other medication in two weeks. There were no concomitant medications. The patient previously took dexilant and had known allergies to the medication. The patient experienced right arm pain, fatigue, myalgia and headache on 12Jan2021 15:00. Treatment for the events included Advil 200 mg. The patient was tested for COVID (Nasal Swab) on 19Nov2020 which showed negative result. The outcome of the events was not recovered.

Other Meds:

Current Illness:

ID: 0976767
Sex: F
Age:
State: MO

Vax Date: 01/07/2021
Onset Date: 01/09/2021
Rec V Date: 01/27/2021
Hospital:

Lab Data: Test Name: EMG; Result Unstructured Data: Test Result:isolated nerve; Test Name: MRI; Result Unstructured Data: Test Result:isolated nerve

Allergies:

Symptoms: I had acute onset Mononeuropathy of the R posterior interosseous nerve; This is a spontaneous report from a contactable physician (patient herself). A 44-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK9231; expiry date: unknown) intramuscular on 07Jan2021 at 16:30, at a single dose, for COVID-19 immunization. The patient has no relevant medical history, has no known allergies, and has no concomitant medications. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The patient previously received first dose of (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK5730; expiry date: unknown) on 17Dec2020 at 12:00, for COVID-19 immunization. The patient stated that 48 hours after administration, on 09Jan2021 at 15:00, she had an acute onset mononeuropathy of the right (R) posterior interosseous nerve. Patient stated this may be unrelated and she wanted to know if this is a trend. She was seen by neuro, she had electromyogram (EMG) and magnetic resonance imaging (MRI) and it was definitely an isolated nerve. The event was treated with prednisone. Outcome of the event was recovering. The patient has not been tested for COVID-19 since vaccination.; Sender's Comments: Based on the information currently provided, the vaccination with BNT162B2 might play a contributory role in triggering the onset of mononeuropathy. 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: 0976768
Sex: F
Age:
State: OR

Vax Date: 01/13/2021
Onset Date: 01/13/2021
Rec V Date: 01/27/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Chemical taste in mouth; This is a spontaneous report from a non-contactable other hcp (patient). A 51-year-old female patient received their first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: Ek9231, expiry date not reported), via an unspecified route of administration on 13Jan2021 13:30 at single dose for COVID-19 immunization. The patient medical history was not reported. Concomitant medication included fluoxetine hydrochloride (PROZAC). The patient experienced chemical taste in mouth on 13Jan2021 14:00. The patient did not have COVID prior to vaccination and has not tested positive post vaccination. The patient was recovering from the event. No follow up attempts are possible. No further information is expected.

Other Meds: PROZAC

Current Illness:

ID: 0976769
Sex: F
Age:
State: PA

Vax Date: 01/11/2021
Onset Date: 01/12/2021
Rec V Date: 01/27/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Facial swelling; Numbness and tingling of Mouth, tongue and face; Numbness and tingling of Mouth, tongue and face; Numbness and tingling of Mouth, tongue and face; Numbness and tingling of Mouth, tongue and face; This is a spontaneous report from a contactable other hcp (patient) reported that a 36-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: El1284), via an unspecified route of administration on the left arm on 11Jan2021 13:00 at a single dose for Covid-19 immunization. Medical history included endometriosis, gastrooesophageal reflux disease (GERD) and liver lesion; all from an unknown date. Concomitant medications included fish oil (FISH OIL), omeprazole (PROTONIX [OMEPRAZOLE]) and sertraline hydrochloride (ZOLOFT); all were taken from an unspecified date for an unspecified indication. The patient previously took amantadine and experienced drug allergy. On 12Jan2021 03:00, the patient experienced facial swelling, and numbness and tingling of mouth, tongue and face. Therapeutic measures were taken as a result of facial swelling, numbness and tingling of mouth, tongue and face. The reported events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The outcome of the events was not recovered.

Other Meds: FISH OIL; PROTONIX [OMEPRAZOLE]; ZOLOFT

Current Illness:

ID: 0976770
Sex: F
Age:
State: AK

Vax Date: 01/08/2021
Onset Date: 01/09/2021
Rec V Date: 01/27/2021
Hospital:

Lab Data: Test Date: 20210109; Test Name: Heartbeat; Result Unstructured Data: Test Result:rapid

Allergies:

Symptoms: Soreness in neck; headache; nausea; joint ache; jaws hurting; rapid heartbeat; fatigue; This is a spontaneous report from a contactable other healthcare professional (patient). A 55-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EL3248), via an unspecified route of administration on 08Jan2021 14:30 (reported as 02:30 PM) at single dose on the left arm for COVID-19 immunization. Patient is not pregnant. Medical history included Attack cardia, reflux and arthritis. Concomitant medications (other medications in two weeks) included amoxicillin, verapamil, omeprazole, estradiol (ESTROGEN) and cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]). No other vaccine in four weeks. The patient previously took morphine, Remeron, azithromycin and digoxin and experienced allergies. No COVID prior vaccination. The patient experienced soreness in neck, headache, nausea, joint ache, jaws hurting, rapid heartbeat and fatigue on 09Jan2021 8:00 AM. No treatment received for the events. Outcome of the events was recovering. Patient was not tested for COVID post vaccination.

Other Meds: AMOXICILLIN; VERAPAMIL; OMEPRAZOLE; ESTROGEN; ZYRTEC [CETIRIZINE HYDROCHLORIDE]

Current Illness:

ID: 0976771
Sex: F
Age:
State: FL

Vax Date: 01/11/2021
Onset Date: 01/11/2021
Rec V Date: 01/27/2021
Hospital:

Lab Data: Test Date: 20210111; Test Name: temperature; Result Unstructured Data: Test Result:fever

Allergies:

Symptoms: Throat tightness/numbness; Throat tightness/numbness; Shortness of breath w/min exertion; Dull chest pain; Right calf pain/cramping; Right calf pain/cramping; Fever; Chill; Body aches; Severe headache; Left arm swelling; left arm swelling, redness, knot; left arm swelling, redness, knot; Pain at injection site; Fatigue; This is a spontaneous report received from a contactable nurse (who is also the patient). A 59-year-old female patient received the second dose of BNT162B2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284, expiry date: unknown), intramuscular in the left arm, on 11Jan2021 07:30, at single dose, for COVID-19 immunization, in the hospital. Medical history included COVID-19 (COVID prior vaccination: Yes) and known allergies to penicillin and erythromycin. There were no concomitant medications. Historical vaccine included the first dose of BNT162B2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899, expiry date: unknown), intramuscular in the left arm, on 23Dec2020 07:15, for COVID-19 immunization. The patient experienced shortness of breath w/min exertion, right calf pain/cramping, fever, chill, body aches, severe headache, left arm swelling, redness, knot and pain at injection site, dull chest pain, fatigue, throat tightness/numbness on 11Jan2021. The events resulted to emergency room/department or urgent care visit. The patient did not receive treatment for the events. The patient was not tested for COVID-19 post vaccination. The outcome of the events was not recovered.; Sender's Comments: The 59-year-old patient received the second dose of BNT162B2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE) on 11Jan2021, and experienced shortness of breath w/min exertion, dull chest pain, throat tightness/numbness and other symptoms on the same day. Considering plausible temporal relationship, the events were probably related to the second dose of BNT162B2. The case will be reassessed should additional information become 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: 0976772
Sex: F
Age:
State: PA

Vax Date: 01/05/2021
Onset Date: 01/06/2021
Rec V Date: 01/27/2021
Hospital:

Lab Data: Test Date: 20210101; Test Name: Nasal Swab; Test Result: Negative

Allergies:

Symptoms: Dizziness, fever, sore/dry throat, severe headache, muscle aches, swollen lymph nodes, sore arm at injection site, chills. Dizziness and headache persisting from time to time; Dizziness, fever, sore/dry throat, severe headache, muscle aches, swollen lymph nodes, sore arm at injection site, chills. Dizziness and headache persisting from time to time; Dizziness, fever, sore/dry throat, severe headache, muscle aches, swollen lymph nodes, sore arm at injection site, chills. Dizziness and headache persisting from time to time; Dizziness, fever, sore/dry throat, severe headache, muscle aches, swollen lymph nodes, sore arm at injection site, chills. Dizziness and headache persisting from time to time; Dizziness, fever, sore/dry throat, severe headache, muscle aches, swollen lymph nodes, sore arm at injection site, chills. Dizziness and headache persisting from time to time; Dizziness, fever, sore/dry throat, severe headache, muscle aches, swollen lymph nodes, sore arm at injection site, chills. Dizziness and headache persisting from time to time; Dizziness, fever, sore/dry throat, severe headache, muscle aches, swollen lymph nodes, sore arm at injection site, chills. Dizziness and headache persisting from time to time; Dizziness, fever, sore/dry throat, severe headache, muscle aches, swollen lymph nodes, sore arm at injection site, chills. Dizziness and headache persisting from time to time; Dizziness, fever, sore/dry throat, severe headache, muscle aches, swollen lymph nodes, sore arm at injection site, chills. Dizziness and headache persisting from time to time; This is a spontaneous report from a contactable other hcp. A 27-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number:ek9x31 and expiry date unknown), intramuscular on the right arm on 05Jan2021 11:45 at a SINGLE DOSE for covid-19 immunisation. Medical history included pneumonia, bronchitis and sinusitis from an unknown date and unknown if ongoing. Concomitant medication included ethinylestradiol, norgestimate (TRI-SPRINTEC), fish oil (FISH OIL) and olly womans multivitamin. The patient experienced dizziness, fever, sore/dry throat, severe headache, muscle aches, swollen lymph nodes, sore arm at injection site and chills on 06Jan2021. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 01Jan2021. Therapeutic measures were taken as a result of the events. The patient was advised to rest for 2 days and take Tylenol. The outcome of the events was recovered with sequelae.

Other Meds: TRI-SPRINTEC; FISH OIL

Current Illness:

ID: 0976773
Sex: F
Age:
State:

Vax Date:
Onset Date: 01/12/2021
Rec V Date: 01/27/2021
Hospital:

Lab Data: Test Date: 20210112; Test Name: Covid; Test Result: Positive

Allergies:

Symptoms: She received 1st dose of Covid vaccine and then tested positive for Covid.; She received 1st dose of Covid vaccine and then tested positive for Covid.; This is a spontaneous report from a contactable other health professional from a Pfizer-sponsored program Pfizer First Connect. A female elderly patient (Grandmother, 80 or older) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received 1st dose of covid vaccine and then tested positive for covid on 12Jan2021. The patient underwent lab tests and procedures which included Covid: positive on 12Jan2021. The reporter's grandmother (female, caller stated age is 80 or older) received the vaccine 3 weeks ago and was scheduled to get the vaccine tomorrow but tested positive for covid on 12Jan2021. The reporter was wondering whether she could get the 2nd dose in this case. She's asymptomatic, not sure when she came down with it. She resided in a Senior care facility. They would have (Pharmacy name) coming tomorrow to get the vaccine. They stated she won't be getting it. The reporter was asked whether it would lose effectiveness if wait and whether the efficacy would go down If wait longer to get the 2nd dose. The outcome of events was unknown. Information on the batch number and lot number has been requested.

Other Meds:

Current Illness:

ID: 0976774
Sex: F
Age:
State: FL

Vax Date: 01/11/2021
Onset Date: 01/11/2021
Rec V Date: 01/27/2021
Hospital:

Lab Data:

Allergies:

Symptoms: body aches; chills; severe headache/Extreme headache; chest discomfort/chest pain/heaviness/Feels like something is heavy on my chest; chest discomfort/chest pain/heaviness/Feels like something is heavy on my chest; extremely tired; not able to carry out daily activities; This is a spontaneous report from a contactable other health care professional. A 40-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 11Jan2021 07:45 at SINGLE DOSE at left arm for COVID-19 immunization. Medical history reported as none. The patient has no known allergies. The patient received first dose of COVID19 vaccine BNT162B2 on 24Dec2020 11:45PM at left arm. There were no concomitant medications. The patient stated, On 11Jan2021 16:00, "I'm having body aches, chills, severe headache/extreme headache and chest discomfort/chest pain. I understand that the body is trying to build an immune response and I understand that body aches and chills are part of that but I don't get headaches, ever, and I have never had chest discomfort or heaviness like this so how is that an immune response. I want you to tell me why I feel this way." It was also reported that the patient was extremely tired, and not able to carry out daily activities. The patient did not receive treatment for the events. The outcome of the events was not recovered. AE resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Information about batch/lot number has been requested.

Other Meds:

Current Illness:

ID: 0976775
Sex: U
Age:
State: IN

Vax Date: 01/11/2021
Onset Date: 01/11/2021
Rec V Date: 01/27/2021
Hospital:

Lab Data:

Allergies:

Symptoms: fatigue; headache; fever; This is a spontaneous report from a contactable nurse (patient). A 38-year-old patient of an unspecified gender received 2nd dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date unspecified), via an unspecified route of administration on 11Jan2021, 07:45, at single dose (right arm) for COVID-19 immunization. Medical history included asthma, atrial septal aneurysm, anxiety and migraines. The patient had known allergies. Concomitant medications were not reported. Patient had other unspecified medications in 2 weeks. The patient previously took first dose of bnt162b2 on 21Dec2020, 07:45, right arm for COVID-19 immunization. On 11Jan2021 at 22:00, the patient experienced fatigue, headache and fever. The patient had no other vaccine in four weeks. The patient did not have Covid prior vaccination and was not Covid tested post vaccination. Outcome of events was recovering. Information about lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 0976776
Sex: F
Age:
State: WA

Vax Date: 12/31/2020
Onset Date: 12/31/2020
Rec V Date: 01/27/2021
Hospital:

Lab Data: Test Date: 20201231; Test Name: blood pressure; Result Unstructured Data: Test Result:went up; Test Date: 20201231; Test Name: pulse; Result Unstructured Data: Test Result:went up

Allergies:

Symptoms: intermittent dizziness; felt a "closing in" sensation/brain fog; pulse and blood pressure went up; pulse and blood pressure went up; severe headache; hot flushing; chest tightness; started getting pale; sweating; peripheral perfusion worsened; palpitations; This is a spontaneous report from a contactable nurse (patient). A 45-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, unknown lot number and expiration), intramuscular in left arm on 31Dec2020 at 08:15 AM at a single dose for COVID-19 immunization in a workplace clinic. Medical history included mild asthma and known allergies to bee stings. There were no concomitant medications. Within a few minutes of the vaccine on 31Dec2020, the patient felt a "closing in" sensation and then her pulse and blood pressure went up. She developed a severe headache and hot flushing with chest tightness. The medical team gave her epinephrine in right thigh and she felt a bit better. Then she started getting pale, sweating, and peripheral perfusion worsened so she was given a second dose of epi. She started feeling better, but had a headache, palpitations and "brain fog" for about 5 days after and she still having intermittent dizziness (unspecified date). The patient received epinephrine IM and benadryl IV push for the events. The events resulted in emergency room/department or urgent care visit. The patient has no COVID prior to vaccination and was not tested for COVID post vaccination. The patient did not receive other vaccine in four weeks and other medications in two weeks. The patient recovered from the events with lasting effects. The patient had not yet recovered from the event dizziness, while the patient recovered with sequelae for the remaining events. Information on the lot/batch number has been requested.; Sender's Comments: The reported events were likely related to the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), due to plausible temporal relationship. The case will be reassessed should additional information become 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: 0976777
Sex: F
Age:
State: MD

Vax Date: 01/09/2021
Onset Date: 01/09/2021
Rec V Date: 01/27/2021
Hospital:

Lab Data:

Allergies:

Symptoms: severe incapacitating headache starting several hours after vaccine and lasting at least through today 13Jan2021. Steroids prescribed today; This is a spontaneous report from a contactable nurse (patient). A 55-year-old female patient receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EH9899 and expiration date not provided), via an unspecified route of administration (right arm) first dose on 09Jan2021 11:30 at single dose for covid-19 immunisation. The patient's medical history included Asthma and hypertension. The patient's concomitant medication includes unspecified medication. On 09Jan2021 23:00, the patient experienced severe incapacitating headache starting several hours after vaccine and lasting at least through today 13Jan2021. The patient event resulted in doctor or other healthcare professional office/clinic visit and Steroids prescribed today. Treatment includes prednisone. The outcome of the event was unknown.; Sender's Comments: Based on the compatible time association and drug's safety profile, the event headache is possibly related to suspect BNT162B2 administration. 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: 0976778
Sex: F
Age:
State: NJ

Vax Date: 01/12/2021
Onset Date: 01/12/2021
Rec V Date: 01/27/2021
Hospital:

Lab Data: Test Name: blood pressure; Result Unstructured Data: Test Result:went up; Test Name: Heart rate; Result Unstructured Data: Test Result:160

Allergies:

Symptoms: heart started to race; tingling sensation from her left arm that radiated to all over her body to the point where she felt paralyzed; tingling sensation from her left arm that radiated to all over her body to the point where she felt paralyzed; heart rate jumped to 160; heart rate jumped to 160 and blood pressure went up; choking sensation on her neck; This is a spontaneous report from a contactable healthcare professional. A 42-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EL1284/expiration date), dose number 2 via an unspecified route of administration on 12Jan2021 at a single dose on the left arm for COVID-19 immunization. Medical history was not reported. The patient did not have COVID prior vaccination. The patient previously took nitroglycerin and experienced drug allergy. Historical vaccine included BNT162B2 (lot number EL0140, dose number 1) for immunization on 22Dec2020 after which the patient experienced mild headache. Concomitant medications were not reported. There were no other vaccines received within 4 weeks. The patient had no adverse reaction other than mild headache after the first dose, so she was very relaxed and she felt comfortable getting the 2nd dose. However, after 10 minutes after the second dose, her heart started to race and she started to feel a tingling sensation from her left arm that radiated to all over her body to the point where she felt paralyzed. Her heart rate jumped to 160 and her blood pressure went up. She couldn't even open her eyes nor speak a word. She was transported to the ER and was given steroids and anti-histamine. She refused to get an epinephrine shot at first, but she started to feel choking sensation on her neck so she asked for an epi shot. The patient had not been tested for COVID post-vaccination. The outcome of the events was recovering.; Sender's Comments: Based on temporal association, a possible contributory role of BNT162B2 cannot be excluded for reported events heart racing, tingling sensation, paralyzed, heart rate high, blood pressure increased and chocking sensation. 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: 0976779
Sex: M
Age:
State: MD

Vax Date: 01/11/2021
Onset Date: 01/11/2021
Rec V Date: 01/27/2021
Hospital:

Lab Data:

Allergies:

Symptoms: sig elevation in previously controlled HTN; chills without fever; extreme fatigue; upset stomach without true nausea and loss of appetite; upset stomach without true nausea and loss of appetite; This is a spontaneous report from a contactable physician (patient). A 54-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL0142), via an unspecified route of administration on 11Jan2021 08:30 at a single dose for COVID-19 immunization. Medical history included hypertension, environmental allergies, and COVID-19. Concomitant medication included nebivolol hydrochloride (BYSTOLIC), cetirizine hydrochloride (ZYRTEC), and esomeprazole magnesium (NEXIUM [ESOMEPRAZOLE MAGNESIUM]). The patient experienced sig elevation in previously controlled HTN, chills without fever, extreme fatigue, upset stomach without true nausea and loss of appetite on 11Jan2021. No treatment received for adverse events. The outcome of the events was recovering. Facility type Vaccine was Hospital. No other vaccine in four weeks. The patient was not COVID tested post vaccination.

Other Meds: BYSTOLIC; ZYRTEC; NEXIUM [ESOMEPRAZOLE MAGNESIUM]

Current Illness:

ID: 0976780
Sex: M
Age:
State: VA

Vax Date: 01/12/2021
Onset Date: 01/01/2021
Rec V Date: 01/27/2021
Hospital:

Lab Data: Test Date: 20210112; Test Name: COVID-19 nasal swab and PCR tests; Test Result: Negative

Allergies:

Symptoms: Extreme arm soreness; Chills; Fever; Headache; It felt like he got the flu; This is a spontaneous report from a non-contactable pharmacist (patient). A 35-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EJ1686), via an unspecified route of administration in left arm, on 12Jan2021 at 12:00, at a single dose, for COVID-19 immunization. The patient's medical history included COVID-19 (prior to vaccination). There were no concomitant medications. No other vaccine was administered in four weeks. The facility where the vaccine was administered was in a nursing home or senior living facility. On 12Jan2021 at 10 PM, the patient had extreme arm soreness that did not go away with ibuprofen or paracetamol (TYLENOL). The patient had chills and a fever the night he got the injection. The patient also had a headache for 2 days after the injection (Jan2021). It felt like he got the flu in Jan2021. Post vaccination on 12Jan2021, the patient underwent COVID-19 nasal swab and PCR tests that was negative. Therapeutic measures were taken as a result of "Extreme arm soreness" including ibuprofen and paracetamol; no treatment was administered for the other events. The patient was recovering from the events. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 0976781
Sex: F
Age:
State: GA

Vax Date: 01/12/2021
Onset Date: 01/12/2021
Rec V Date: 01/27/2021
Hospital:

Lab Data: Test Date: 20210112; Test Name: BP; Result Unstructured Data: Test Result:193/113; Comments: elevated; Test Date: 20210112; Test Name: EKG; Result Unstructured Data: Test Result:Unknown results; Test Date: 20210112; Test Name: BPM; Result Unstructured Data: Test Result:134; Test Date: 20210112; Test Name: pulse; Result Unstructured Data: Test Result:Unknown results; Test Date: 20210112; Test Name: lab work; Result Unstructured Data: Test Result:Unknown results

Allergies:

Symptoms: elevated BP : 193/113; Tachycardia 134 BPM; bad headache; numbness and tingling in both hands; numbness and tingling in both hands; nausea; rash across the top of my chest; sore muscles in legs; This is a spontaneous report from a contactable nurse. A 53-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EL1283, via intramuscular route of administration in the left arm, on 12Jan2021 10:30 at SINGLE DOSE for covid-19 immunization. Medical history included asthma, sinusitis and migraine. Concomitant medications included fluticasone propionate, salmeterol xinafoate (ADVAIR), albuterol, estradiol, norethisterone acetate (ESTRADIOL AND NORETHINDRONE), vitamin d3, zinc, paracetamol (TYLENOL) and diphenhydramine hydrochloride (BENADRYL). The patient previously took erythromycin, levaquin, biaxin and cefzil (on unspecified dates) and experienced allergy. The patient started having reactions after 20 mins (12Jan2021, 10:45am): a bad headache, elevated BP: 193/113 (no history of hypertension), tachycardia 134 BPM, numbness and tingling in both hands, nausea, and a rash across the top of the chest. Since it was administered in a workplace drive-thru clinic, there was a 15-30 mins post vaccine monitoring. She was taken inside for further evaluation and monitoring with no changes after 30 mins. EMS was called for transport to the closet hospital that wasn't on diversion. Her allergist was consulted by the treating ER physician and was later discharged with prescriptions for the following: Epipen, prednisone for 5 days, and pepcid. Follow-up with allergist in 3-5 days and PCP. Patient was still recovering however headache was and sore muscles in legs were still present. The outcome of events headache was and sore muscles in legs was not recovered whereas patient was recovering from all other events. Therapeutic measures taken as result of the events included Benadryl, Pepcid, Zofran, Tylenol, 1L Saline bolus, EKG, lab work, monitoring on a pulse ox, frequent BP. No follow-up attempts are possible. No further information is expected. Information on the lot/batch number has been obtained.; Sender's Comments: Based on the compatible time association, the reported events are possibly related to suspect BNT162B2 administration. 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: ADVAIR; ALBUTEROL [SALBUTAMOL]; ESTRADIOL AND NORETHINDRONE; VITAMIN D3; ZINC; TYLENOL; BENADRYL

Current Illness:

ID: 0976782
Sex: F
Age:
State: WI

Vax Date: 12/31/2020
Onset Date: 12/31/2020
Rec V Date: 01/27/2021
Hospital:

Lab Data:

Allergies:

Symptoms: rash and itchiness on face and chest; rash and itchiness on face and chest; anxiety; feeling restless/shakiness; insomnia; difficulty concentrating; feeling restless/shakiness; she developed sudden chest tightness; throat hoarseness; scratchiness; lightheadedness; This is a spontaneous report from a contactable pharmacist. An adult female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration on 31Dec2020 10:45 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Approximately 5 minutes later on 31Dec2020 10:50, she developed sudden chest tightness, throat hoarseness and scratchiness, and lightheadedness. Staff responded with AED and rescue meds, called for EMS transport to ED. Employee reported that at ED , the patient was treated with rescue medications including Benadryl, Pepcid, solumedrol, but symptoms continued to worsen, therefore epi was given which improved symptoms. The patient was observed in ED for approximately 6 hours before being discharged home with oral antihistamines, steroid pack, and an epi-pen. Once home, employee experienced a rash and itchiness on face and chest which has now resolved. Patient was still experiencing side effects from medications including insomnia, anxiety, difficulty concentrating, and feeling restless/shakiness. The outcome of the events sudden chest tightness, throat hoarseness and scratchiness, and lightheadedness was recovering; the outcome of the events rash and itching was recovered on an unknown date; while the outcome of the remaining events was not recovered. Information on the lot/batch number has been requested.; Sender's Comments: Based on a close chronological association, a causal relationship between events chest tightness, throat hoarseness and scratchiness, and lightheadedness occurred approx. 5 minutes after vaccination and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE,) 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: 0976783
Sex: F
Age:
State: CA

Vax Date: 01/09/2021
Onset Date: 01/01/2021
Rec V Date: 01/27/2021
Hospital:

Lab Data: Test Date: 202101; Test Name: oxygen level; Result Unstructured Data: Test Result:89 to 90

Allergies:

Symptoms: Shortness of breath; chest was hurting; Headache; Feeling tired; Joint aches; oxygen at the time, and it was 89 to 90; achy; This is a spontaneous report from a contactable nurse (patient). A 59-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, unknown lot number and expiration), via an unspecified route of administration right deltoid on 09Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; unknown lot number and expiration) on 21Dec2020 via injection in left deltoid for COVID-19 immunization. The patient reported that she feels fine today (13Jan2021), but she received her second dose of the COVID vaccine on Saturday, 09Jan2021. She experienced side effects including headache, feeling tired, and joint aches on 11Jan2021. She also experienced shortness of breath on 12Jan2021. The shortness of breath started early Tuesday morning in the middle of the night. She would say that it was like her chest was hurting. She measured her oxygen at the time, and it was 89 to 90 (Jan2021). It gradually went up from there. This lasted about 3 hours. She is fine now. She would say these are all not serious as she knew it could be from the vaccine and she was keeping an eye on it. She could get up and do things she was just achy (Jan2021). It took her by surprise. She does not know if this is a known side effect or if it should be expected or if she should report this. The patient recovered from the events "oxygen at the time, and it was 89 to 90" on unspecified date; headache and joint aches on 11Jan2021; shortness of breath and "chest was hurting" on 12Jan2021; feeling tired on 13Jan2021; while unknown outcome for the remaining events. The events shortness of breath, joint aches, feeling tired, and headache were assessed as related to COVID vaccine by the reporter. The event shortness of breath, feeling tired, joint aches, and headache was assessed as non-serious Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 0976784
Sex: F
Age:
State: CA

Vax Date: 01/11/2021
Onset Date: 01/11/2021
Rec V Date: 01/27/2021
Hospital:

Lab Data: Test Date: 20210111; Test Name: Blood pressure; Result Unstructured Data: Test Result:b/p low; Test Date: 20210111; Test Name: Body temperature; Result Unstructured Data: Test Result:100.4; Test Date: 20210111; Test Name: tachycardia; Result Unstructured Data: Test Result:119-135

Allergies:

Symptoms: weak; hot flashes; cramping; joints hurt; her hands & feet were so cold they hurt (like when holding snow with bare hands); her hands & feet were so cold they hurt (like when holding snow with bare hands); anxiety; dizzy; her body feels weird; sweating; b/p low; throat hurts; tachycardia (119-135); 100.4; chills; body ache; nausea; vomiting; pounding headache; eyes burning; face & neck felt flushed; This is a spontaneous report from a non-contactable nurse (patient). A 41-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), intramuscular on 11Jan2021 16:00 at a single dose on left arm for COVID-19 immunization. Medical history included asthma, hypoglycemia, vitamin d deficiency, migraines, and allergy to Ilizone (unspecified). The patient was not diagnosed with COVID prior to vaccination. The patient was not pregnant at the time of vaccination. Concomitant medications included loratadine (ALAVERT), phentermine, ibuprofen, and paracetamol (TYLENOL). The patient was administered with first dose of bnt162b2 on 21Dec2020 for COVID-19 immunization (product-COVID 19, brand-Pfizer, lot number-EH9899, administration time-11:45 AM, administrator route-intramuscular, vaccine location-right arm). The patient previously took salbutamol sulfate (VOLMAX) and experienced allergy. No other vaccines in four weeks prior to COVID vaccination. On 11Jan2021 17:00, the patient experienced body temperature of 100.4 (no unit reported), chills, body ache, nausea, vomiting, pounding headache, eyes burning, face and neck felt flushed, tachycardia (her watch kept alarming 119-135), weak, hot flashes, cramping, joints hurt, her hands and & feet were so cold they hurt (like when holding snow with bare hands), anxiety, dizzy, her body feels weird, sweating, b/p (blood pressure) low, and throat hurts. There was no treatment given for the events. The patient has not been tested for COVID post vaccination. The patient is recovering from the events. No follow-up attempts are possible. No further information is expected.

Other Meds: ALAVERT; PHENTERMINE; IBUPROFEN; TYLENOL

Current Illness:

Total 2021 VAERS Injuries: 134,999

Page last modified: 14 December 2021 10:42pm