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: 1000206
Sex: F
Age:
State: PA

Vax Date: 12/18/2020
Onset Date: 12/18/2020
Rec V Date: 02/04/2021
Hospital:

Lab Data: Test Name: Blood pressures; Result Unstructured Data: Test Result:155/95; Test Name: Blood pressures; Result Unstructured Data: Test Result:135/85; Test Date: 20210120; Test Name: Blood pressures; Result Unstructured Data: Test Result:117/68; Test Name: blood work; Result Unstructured Data: Test Result:normal; Test Name: EKG; Result Unstructured Data: Test Result:normal

Allergies:

Symptoms: Elevation of Blood pressures proceeded with high 155/95; heart flutter; extreme breast tenderness; axillary swelling; felt general unwell feeling; This is a spontaneous report from a contactable healthcare professional reporting for self. This 49-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number= EL0140) via intramuscular on 18Dec2020 12:00 PM at right arm at single dose for COVID-19 immunization. Medical history included known allergies: cinnamon. Patient did not have COVID prior vaccination. Concomitant medications included cyanocobalamin (B12), zinc, 4-(4-hydroxyphenyl)butan-2-one, crocus sativus, magnesium oxide (BELL DE NUIT PRECIOUS MAGICAL). It was reported that first day approx 6 hours after injection patient felt general unwell feeling, next day (19Dec2020) extreme breast tenderness and initiation of axillary swelling. At day 10 post injection (28Dec2020) she experienced some type of heart flutter. Elevation of Blood pressures proceeded with high 155/95 on unspecified date. PCP visit with normal EKG and blood work following week. BP in office 135/85 (from memory). Patient did not receive second dosage at day 21 and BP has currently returned to normal this a.m. (20Jan2021) 117/68. There was no treatment received for events. Patient did not test COVID post vaccination. The outcome of events was recovered.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. 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 RAs, Ethics Committees, and Investigators, as appropriate.

Other Meds: B12 [CYANOCOBALAMIN]; ZINC; BELL DE NUIT PRECIOUS MAGICAL

Current Illness:

ID: 1000207
Sex: F
Age:
State: MN

Vax Date: 01/11/2021
Onset Date: 01/14/2021
Rec V Date: 02/04/2021
Hospital:

Lab Data:

Allergies:

Symptoms: cellulitis in right arm below injection site; fever; headache; chills; fatigue; This is a spontaneous report from a contactable nurse (patient). A 32-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 in right arm on 11Jan2021 at 07:45 AM at a single dose for COVID-19 immunization in a hospital. Medical history reported as none. The patient has no known allergies. The patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; unknown lot number and expiration) on 23Dec2020 at 07:45 AM in left arm for COVID-19 immunization. Concomitant medications included dicyclomine; and unspecified birth control and multivitamin. The patient experienced fever, headache, chills, fatigue, and then got cellulitis in right arm below injection site following second dose of COVID vaccine on 14Jan2021 at 12:00 PM. 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. The patient received antibiotics (Keflex) as treatment for the events. The patient recovered from the events in Jan2021. Information on the Lot/Batch number has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Vaccination site cellulitis cannot be excluded. The case will be reassessed if additional information becomes 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: DICYCLOMINE

Current Illness:

ID: 1000208
Sex: F
Age:
State:

Vax Date: 01/11/2021
Onset Date: 01/15/2021
Rec V Date: 02/04/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Have swelling of Lymph Nodes; This is a spontaneous report from a contactable consumer. A 72-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 11Jan2021 at a single dose for covid-19 immunisation. The patient's medical history included hypertension from an unknown date and unknown if ongoing. Concomitant medication included hydrochlorothiazide, losartan, and amlodipine for hypertension. The patient experienced swelling of lymph nodes on 15Jan2021. The outcome of the event was unknown. Information on the Lot/Batch Number has been requested.

Other Meds: HYDROCHLOROTHIAZIDE; LOSARTAN; AMLODIPINE

Current Illness:

ID: 1000209
Sex: F
Age:
State: NY

Vax Date: 12/29/2020
Onset Date: 12/29/2020
Rec V Date: 02/04/2021
Hospital:

Lab Data:

Allergies:

Symptoms: was supposed to get the second dose yesterday 19Jan2021 but location is closed/ could get it up to the 26Jan2021; paralysis of the chin and half of the face; and around the mouth; This is a spontaneous report from a contactable consumer report for self. A 49-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at right arm on 29Dec2021 20:00 PM for COVID-19 immunization. Medical history included ongoing severe migraines. None family history. There were no concomitant medications. No Prior Vaccinations within 4 weeks. After an hour she had paralysis of the chin and half of the face; and around the mouth. It only lasted a few minutes, like 10 minutes and then it went away, she was fully recovered. She did not got to a doctor or the ER. Adds she was supposed to get the second dose yesterday 19Jan2021 but she has to go to another location as that location is closed. They told her she could get it up to the 26Jan2021 and then it would be more problematic to get. The event outcome was recovered on 29Dec2020. Information on the lot/batch number has been requested.

Other Meds:

Current Illness: Migraine

ID: 1000210
Sex: F
Age:
State: IN

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

Lab Data: Test Name: Lab work; Result Unstructured Data: Test Result:Unknown results; Comments: close to 10 days ago; Test Name: COVID; Test Result: Positive

Allergies:

Symptoms: patient was positive; patient was positive; This is a spontaneous report from a contactable nurse. A 34-year-old female patient (nurse's daughter) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EK9231), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunization. Medical history was none. There were no concomitant medications. The nursed reported that "The patient was positive, the whole family had COVID and they all came down which was about the same time which was 29Dec. She was treated in the ER with steroids and since that point we have all recovered until she went for the 2nd dose. Probably close to 10 days ago, they did do some lab work at the hospital". The outcome of events was unknown.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 cannot be excluded for reported events.

Other Meds:

Current Illness:

ID: 1000211
Sex: U
Age:
State:

Vax Date: 01/14/2021
Onset Date: 01/15/2021
Rec V Date: 02/04/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Diarrhea; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route single dose for COVID-19 immunization on 14Jan2021, 3 o'clock (unspecified in am or pm). Medical history and concomitant medication were not reported. The patient went swimming next day (15Jan2021) for an hour without stopping and did water aerobics and nothing hurt. The patient was doing great but came down with a little diarrhea, Friday, Saturday, and Sunday (from 15Jan2021 to 17Jan2021). The patient woke up this morning (17Jan2021) and stated probably had it during the night. Action taken for BNT162B2 was not applicable. Outcome of the event was unknown. Information on the batch/lot number has been requested.

Other Meds:

Current Illness:

ID: 1000212
Sex: M
Age:
State: WI

Vax Date: 01/19/2021
Onset Date: 01/20/2021
Rec V Date: 02/04/2021
Hospital:

Lab Data: Test Name: IgA; Result Unstructured Data: Test Result:low

Allergies:

Symptoms: typical Bell's Palsy; right side facial pain near the anterior right ear and traveling down the facial cranial nerve from that area to his jaw; right side facial pain near the anterior right ear and traveling down the facial cranial nerve from that area to his jaw; Weak feeling coming from the jaw; This is a spontaneous report from a non-contactable nurse (wife). A 38-year-old male patient (husband) received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot Number EL3248 and Expiration Date unknown) via an unspecified route of administration on 19Jan2021 18:00 (vaccine location: left arm) at single dose for COVID-19 immunisation. The patient's medical history included hypogammaglobulinaemia, from years low IGA, chickenpox and shingles in the past. The concomitant medications were not reported. No history and additional vaccines administered on same date. On 20Jan2021 when patient woke up, right now at 09:21 AM, he noticed right side facial pain near the anterior right ear and traveling down the facial cranial nerve from that area to his jaw. Reporter stated this was typical Bell's Palsy and the usual treatment is the same as for herpes zoster; steroids and antivirals is the recommended treatment. Reporter is planning to call the doctor as she feels he needs treatment right away and she will get the doctor to prescribe this treatment. Patient has a weak feeling coming from the jaw. Patient had a history of chicken pox and chronic herpes zoster but this was the first time he had had Bell's Palsy. States the effects are persisting and medically significant. Patient was scheduled for the second dose 09Feb2021. Wanted to know about if patient should get the second dose of the vaccine. The outcome of events was not recovered. No follow-up attempts are possible. No further information is expected.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. 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 RAs, Ethics Committees, and Investigators, as appropriate.

Other Meds:

Current Illness:

ID: 1000213
Sex: F
Age:
State: AZ

Vax Date: 01/14/2021
Onset Date: 01/14/2021
Rec V Date: 02/04/2021
Hospital:

Lab Data: Test Date: 202101; Test Name: COVID; Test Result: Positive ; Comments: had to go in and get tested for COVID and my result came out this morning positive

Allergies:

Symptoms: tested for COVID and result came out positive/ body ache, fever, headache and cough; tested for COVID and result came out positive/ body ache, fever, headache and cough; This is a spontaneous report from a contactable other healthcare professional (patient). A 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL0142), via an unspecified route of administration, on 24Dec2020 at single dose as first dose, on left deltoid on 14Jan2021 as second dose at single dose to protect patient from COVID. Medical history included prediabetes and blood pressure high. Concomitant medication included metformin for prediabetes, losartan for blood pressure high. The patient's second vaccine (COVID 19 Vaccine) was just past this 14Jan2021. Then she had a lot of symptoms on 14Jan2021, the patient had like body ache, fever, headache and cough. The patient started to have suddenly with the side effects from the vaccine and then it was fine until yesterday and then she had to go in and get tested for COVID because she had never tested positive and her result came out this morning positive in Jan2021. The patient received Tylenol as treatment. The outcome of events was unknown.; 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 second vaccine dose and the event onset.

Other Meds: METFORMIN; LOSARTAN

Current Illness:

ID: 1000214
Sex: F
Age:
State: NC

Vax Date: 12/29/2020
Onset Date:
Rec V Date: 02/04/2021
Hospital:

Lab Data: Test Name: COVID-19 test; Test Result: Positive

Allergies:

Symptoms: Tested positive for the COVID-19; Tested positive for the COVID-19; Headache; This is a spontaneous report from a Pfizer sponsored program Pfizer First Connect via a contactable consumer (patient) reported for herself. A female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 29Dec2020 at single dose for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient got her first dose of this Vaccine date is 29Dec2020 and now she had tested positive for the COVID-19, so she wants to know if what to do if she should take the second dose which is scheduled 19Jan2021. Physician confirmed it was COVID-19 Vaccine of Pfizer. She had got a headache. Events outcome was unknown. Information about lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1000215
Sex: F
Age:
State: SD

Vax Date: 12/30/2020
Onset Date: 12/31/2020
Rec V Date: 02/04/2021
Hospital:

Lab Data:

Allergies:

Symptoms: impairing her from driving/ bothering her while driving; panic; nauseous; increasingly more and more dizziness with visual disturbances; increasingly more and more dizziness with visual disturbances/She feels things are moving that aren't; This is a spontaneous report from a contactable physician, the patient. A 45-year-old female physician received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: EK9231, Expiry: Apr 2021), intramuscularly in the left deltoid on 30Dec2020 at 16:30 (at the age of 45-years-old) as a single dose for COVID-19 immunization. Medical history included heartburn. Concomitant medications included (dexlansoprazole) DEXILANT for heartburn from an unspecified date (reported as a year and a half). The patient did not receive any other vaccinations within 4 weeks prior to the vaccine. On 31Dec2020, the patient experienced dizziness with visual disturbances. She was having increasingly more and more dizziness with visual disturbances where today (20Jan2021) she felt nauseous from that. It was impairing her from driving because she felt things were moving that weren't and made her panic on the interstate, as of an unspecified date. It. Initially it was bothering her while driving, but now she noticed it while sitting at her desk or when she ate. It was all the time now. The reporter assessed the events "increasingly more and more dizziness with visual disturbances/she feels things are moving that aren't" as being between disabling and medically significant. The patient did not visit the emergency room or a physician's office, although stated it probably did require it. The patient queried whether to receive the second dose today as her symptoms were worsening. The clinical outcome of "increasingly more and more dizziness with visual disturbances/she feels things are moving that aren't" was not resolved, and of nauseous, "impairing her from driving/ bothering her while driving" and panic were unknown.; Sender's Comments: Based on a compatible temporal relationship causality between events dizziness with visual disturbances and BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA 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: DEXILANT

Current Illness:

ID: 1000216
Sex: M
Age:
State:

Vax Date: 01/04/2021
Onset Date: 01/01/2021
Rec V Date: 02/04/2021
Hospital: Y

Lab Data: Test Date: 202101; Test Name: CAT scan; Result Unstructured Data: Test Result: pneumonia; Comments: they did a CAT scan, and he had pneumonia in there; Test Date: 202101; Test Name: absolute eosinophils; Result Unstructured Data: Test Result: 22.2; Comments: Eosinophil count high; Test Date: 202101; Test Name: absolute eosinophils; Result Unstructured Data: Test Result: 2.4

Allergies:

Symptoms: Pneumonia; Eosinophil count high; allergic reaction; This is a spontaneous report from a contactable consumer (patient's wife). An 81-year-old male patient received the first dose of COVID-19 vaccine (UNSPECIFIED TRADE NAME), via an unspecified route of administration on 04Jan2021 at single dose for covid-19 vaccination. The patient's medical history and concomitant medications were not reported. The patient had his first vaccine dose on 04Jan, then 7 days later he was in the hospital with a really high eosinophils count and infiltrate in his lungs, they did a CAT scan, and he had pneumonia in there. Patient's wife said that he was in the hospital for three days for Pneumonia, and now he was out of the hospital and he was supposed to get his second dose of the vaccine on the 25th. She would like to know if her husband should have the second dose, since she didn't know if the pneumonia was caused from the vaccine for sure, it could be an allergic reaction for the vaccine since his count was 22.2 for absolute eosinophils and that was down now to 2.4. She would like to know if it was safe for him get the second dose. She said her husband was still coughing and she didn't know, she was afraid for him to get it. The patient underwent lab tests and procedures which included a CAT scan in Jan2021 and he had pneumonia in there , absolute eosinophils: 22.2 (Eosinophil count high) in Jan2021, absolute eosinophils: 2.4 in Jan2021. The outcome of the events was unknown. Information about lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1000217
Sex: F
Age:
State: NC

Vax Date: 01/07/2021
Onset Date: 01/01/2021
Rec V Date: 02/04/2021
Hospital: Y

Lab Data: Test Date: 20210110; Test Name: chest x-ray; Result Unstructured Data: Test Result:they could not diagnose with Shingles.; Test Date: 20210110; Test Name: cat scan; Result Unstructured Data: Test Result:they could not diagnose with Shingles.; Test Date: 20210109; Test Name: test/labs, checked vitals; Result Unstructured Data: Test Result:it all came back fine; Test Date: 20210110; Test Name: test/labs, checked vitals; Result Unstructured Data: Test Result:Unknown results

Allergies:

Symptoms: Disoriented; Urinary tract infection; Shingles/rash; Complaining of pain and burning; Complaining of pain and burning; she was not feeling that well; lose her mental faculties; This is a spontaneous report from a contactable pharmacist. A 94-year-old female patient (reporter's mother) receive the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246), via an unspecified route of administration on 07Jan2021 (around 3:15 PM to 3:20 PM) at 0.3 mL, single (0.3ml dose injection in right arm) for COVID-19 immunization. Medical history included blood pressure, cholesterol, blood thinner and fluid. The patient historical vaccine included varicella zoster vaccine live (ZOSTAVAX) for immunization. There was no history of all previous immunization with the Pfizer vaccine considered as suspect as this was the first dose. The patient had no prior Vaccinations within 4 weeks. Concomitant medications included ongoing apixaban (ELIQUIS) for blood thinner, ongoing furosemide (LASIX) for fluid, valsartan for blood pressure, ongoing pravastatin for cholesterol. The reporter was calling because her mother had the COVID-19 Vaccine on 07Jan2021, it was on a Thursday. By that Friday (08Jan2021) she was not feeling that well. Caller stated she did not know if what occurred had any correlation to the vaccine, but she wanted to report these details in case this started to be came a problem. Her mother is 94 years old and was in very good shape. However, now she was in the hospital completely disoriented. Since getting the vaccine she had subsequently broke out with shingles two days after getting the vaccine on 09Jan2021. Caller reiterated she was not saying this had anything to do with the vaccine, but she just wanted to reported these events. Caller initially stated it was unknown why patient was admitted to the hospital. She went on to explain her mother, the patient, was complaining of pain and burning. She started complaining of this pain and burning in the evening like around 5PM (on 08Jan2021 17:00). She later broke out into shingles. Caller mentioned patient has not had the SHINGRIX vaccine yet. However, she did have the older vaccine, ZOSTAVAX. Caller confirmed patient received the ZOSTAVAX years before. Patient went to the Emergency Room the first time on 09Jan2021 due to complaining of pain and burning and they could not find anything wrong with her. They checked her vitals and ran several tests and it all came back fine. They then sent her home. Patient went back to the Emergency Room on 10Jan2021 and completed another battery of test, labs, checked vitals, had chest x-ray, and cat scan at this time they could not diagnose with Shingles. On 11Jan2021, the patient had an appointment with her Primary Doctor and he did not find anything wrong. Patient came home with caller's sister and she was helping her get undressed. That was when the sister noticed a rash on the patient's body. The rash broke out on her body on Monday 11Jan2021. They tried to call the doctor that night, but did not get a response. On Tuesday 12Jan2021 they took the patient to urgent care and that was when she was formally diagnosed with Shingles. She was started on medication for the Shingles, Acyclovir, and sent home. They also thought she had a slight Urinary Tract Infection. She was started on CIPRO for the urinary tract infection. Patient was home for a couple of days in Jan2021 and she was not getting any better. She was then starting to lose her mental faculties. They thought this was from the urinary tract infection. Caller clarified the patient was then admitted to the hospital on 16Jan2021 due being disoriented. For causality assessment, it was mentioned that it is so coincidental this happened right after getting the vaccine. She was healthy and then it was like a snowball. The outcome of the events was unknown.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events 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: ELIQUIS; LASIX [FUROSEMIDE]; VALSARTAN; PRAVASTATIN

Current Illness:

ID: 1000218
Sex: F
Age:
State: LA

Vax Date: 01/08/2021
Onset Date: 01/14/2021
Rec V Date: 02/04/2021
Hospital:

Lab Data: Test Name: biopsy on her hip; Result Unstructured Data: Test Result:Unknown results; Test Name: height; Result Unstructured Data: Test Result:5 foot 2 inches; Comments: States she used to be 5 foot 2 inches, shrunk prior to vaccine

Allergies:

Symptoms: rash that looks like measles; rash on right side that goes around to back looks like diaper rash; This is a spontaneous report from a contactable pharmacist. An 87-year-old female patient started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number EK9231), via an unspecified route of administration on 08Jan2021 at single dose for covid-19 immunisation. Medical history was none. There were no concomitant medications. The patient stated she had this injection 08Jan2021, states the following Thursday, 14Jan2021, she broke out with 2 different reactions, a rash that looks like measles all over, the second reaction is part on her back looks like a little kid has not had their diaper changed, like diaper rash, like half a belt from the right side to the back. States she is very concerned, the patient went to a dermatologist who she had a lot of faith in, doctor met her at the door, read about it but has never seen a reaction like this. States that they injected her with something and it worked in two different places. States she did a biopsy on her hip and took movies to show her students, called her and stated she need to report this event. The patient states she wants to know if she should get the second vaccine. States she used to be 5 foot 2 inches, shrunk prior to vaccine. The patient last night to report but she could not get through. Stated she got injection on right arm. The patient stated the rashes are trying to improve. States the rash that looks like measles started on the right side and now is all over. The patient stated she is allergic to bromines and swims in a bromine salt water heated swimming pool and this has nothing to do with it but the point she is saying is that she says your allergic to things and then not have reactions and sometimes you do. Both events were serious with criteria of medially signicant. The patient underwent lab tests and procedures which included biopsy: unknown results, body height: 5 foot 2 inches (States she used to be 5 foot 2 inches, shrunk prior to vaccine). The outcome of the event rash that looks like measles was not recovered, while the outcome of the other event was unknown.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events 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: 1000219
Sex: F
Age:
State: FL

Vax Date: 01/19/2021
Onset Date: 01/19/2021
Rec V Date: 02/04/2021
Hospital:

Lab Data: Test Date: 20210119; Test Name: temperature; Result Unstructured Data: Test Result: Low grade fever; Test Date: 20210120; Test Name: temperature; Result Unstructured Data: Test Result: 99.4; Test Date: 20210108; Test Name: coronavirus; Result Unstructured Data: Test Result: negative

Allergies:

Symptoms: one of the nurses at the outpatient clinic where she works was positive for covid; Nausea; she started feeling a little warm; Low grade fever; Chills; This is a spontaneous report from a contactable nurse reporting for herself. A 67-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3302), intramuscularly on 19Jan2021 11:03 on right arm at single dose for COVID-19 immunization. Vaccination Facility Type was at Clinic. Medical history included just had rotator cuff repair surgery last Thursday (11Jan2021), pain, muscle relaxer. Concomitant medications included acetaminophen; hydrocodone as pain medicine, methocarbamol as muscle relaxer. Historical Vaccine included first dose of BNT162B2 (Lot number: EK9231) intramuscularly on 28Dec2020 at 9:52 am for COVID-19 immunization on right arm and experienced right arm soreness at the injection site. It was reported that last night (19Jan2021) she had a low grade fever and chills, then it went away, she was not having the chills earlier today and the fever went away. The fever had come back and she was chilled even though it was hot. She tested negative for coronavirus that Monday (08Jan2021) prior to the surgery. She was being told that one of the nurses at the outpatient clinic where she worked was positive for covid. She clarified that the fever and the chills go together and started last night. The fever did get better and she was not feeling feverish or chilled during the day. About 2 or 3 hours ago (20Jan2021) she started feeling a little warm, nauseated and she checked her temperature 30 minutes ago and it was 99.4. She always run low and did not have a fever. No treatment received for all events. The outcome of event low grade fever was resolving, outcome of events chills and nauseated were not resolved, outcome of other events were unknown.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events low grade fever, chills and nausea 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: ACETAMINOPHEN;HYDROCODONE; METHOCARBAMOL

Current Illness:

ID: 1000220
Sex: F
Age:
State: IN

Vax Date: 01/17/2021
Onset Date: 01/17/2021
Rec V Date: 02/04/2021
Hospital:

Lab Data: Test Date: 20210117; Test Name: heart beat; Result Unstructured Data: Test Result:fast; Test Date: 202101; Test Name: blood work; Result Unstructured Data: Test Result:Unknown results

Allergies:

Symptoms: My body aches/My whole body is aching; Fast heartbeat; I have difficulty in breathing; This is a spontaneous report from a contactable consumer (patient). An 81-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249), via an unspecified route of administration from 17Jan2021 at 0.3 mL single for COVID-19 immunization. Medical history included immunotherapy for breathing, for her lungs. Concomitant medication included umeclidinium bromide, vilanterol trifenatate (ANORO) for immunotherapy for breathing. The patient whole body was aching from the shot (Later clarified as COVID 19 Vaccine Pfizer) that she got yesterday (on 17Jan2021). She had fast heart beats and she had difficulty in breathing and her whole body was really aching. Her whole body aches and pain of her body. The patient wanted to know how to get rid of the pain. The patient thought that she took treatment included Advil. And patient was still achy. The due date for next shot was on 07Feb2021. The patient underwent lab tests and procedures which included heart rate fast on 17Jan2021 and had lab work last week (in Jan2021), that was for her blood work. The outcome of the event whole body was aching was not recovered, of the rest events was unknown.

Other Meds: ANORO

Current Illness:

ID: 1000221
Sex: U
Age:
State:

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

Lab Data:

Allergies:

Symptoms: chills; high anxiety; nervous wreck; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that the patient had some chills and high anxiety, also mentioned being a nervous wreck on an unspecified date. Outcome of the events was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1000222
Sex: M
Age:
State: TX

Vax Date: 01/16/2021
Onset Date: 01/17/2021
Rec V Date: 02/04/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Hives; This is a spontaneous report from a contactable consumer (patient). A 64-years-old male patient received second dose of bnt162b2 (BNT162B2, lot number: EL3249), via an unspecified route of administration on 16Jan2021 07:00 on Left upper Arm at SINGLE DOSE for covid-19 immunisation. Medical history included Blood pressure, High cholesterol, Asthma. Concomitant medication included losartan for high cholesterol, montelukast for asthma, valsartan for blood pressure. The patient woke-up at 5 AM with hives on 17Jan2021. The event was treated with Benadryl and have the hydrocortisone cream that went away and came back, that went away and came back and came back again in the morning of reporting date, so the consumer didn't know it's related. Investigation Assessment: No. The event outcome was not recovered.

Other Meds: LOSARTAN; MONTELUKAST; VALSARTAN

Current Illness:

ID: 1000223
Sex: F
Age:
State: ND

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

Lab Data:

Allergies:

Symptoms: dizzy; throwing up; Head spinning; nausea; This is a spontaneous report from a contactable nurse (patient). A 22-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL1284), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation. There were no medical history or concomitant medications. The patient started to get like extremely dizzy, was throwing up, head spinning, had horrible nausea; started to get really carsick on an unspecified date. The patient went into a walk in a clinic and that gave her ondansetron (ZOFRAN). So, she had been taking that for the nausea and the vomiting. She had also been taking meclozine (MECLIZINE) and dimenhydrinate (DRAMAMINE) too. The outcome of event dizzy was not recovered, while for other events was unknown.

Other Meds:

Current Illness:

ID: 1000224
Sex: F
Age:
State: CA

Vax Date: 01/15/2021
Onset Date: 01/16/2021
Rec V Date: 02/04/2021
Hospital:

Lab Data:

Allergies:

Symptoms: I am kind of tired; Redness and little bit of swelling, a patch that is getting bigger just below the site where the injection was; Redness and little bit of swelling, a patch that is getting bigger just below the site where the injection was; Pain; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), Lot number: GL1283, on 15Jan2021 at 10 AM at single dose for COVID-19 immunization. The patient had some medical history, but not reported. Concomitant medications were not reported. Patient stated, she received her second dose of the COVID Pfizer vaccine (COVID 19 Vaccine) on Friday at 10 AM and usual it pained next day (16Jan2021) but they went away by the end of the day. However, she noticed that yesterday (17Jan2021) and today (18Jan2021) there was redness and little bit of swelling, a patch that was getting bigger just below the site where the injection was made. Yesterday it was smaller. Today the part was larger and little bit swollen So she thought she better see what's going on. Patient stated she was kind of tired. She was old. For treatment, the patient went to the drug store today and got some Benadryl. So, she took two Benadryl tablets at about three hours prior to the report and it hadn't effected it one way or the other. The patient didn't have any lab test. Patient's height was 5'5 and three quarters. The outcome of the events "Pain" and "Redness and little bit of swelling, a patch that is getting bigger just below the site where the injection was" was not recovered at the time of report. The outcome of tired was unknown.

Other Meds:

Current Illness:

ID: 1000225
Sex: F
Age:
State: FL

Vax Date: 01/15/2021
Onset Date: 01/01/2021
Rec V Date: 02/04/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Dizzy; She is not feeling well; When she went home she fell, she had a terrible fall and she got a terrible bruise on her head; When she went home she fell, she had a terrible fall and she got a terrible bruise on her head; Tired; This is a spontaneous report from a Pfizer-sponsored program via a contactable consumer (patient). A female patient of an unspecified age received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 15Jan2021 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. In Jan2021, the patient experienced dizzy, she was not feeling well, when she went home she fell, she had a terrible fall and she got a terrible bruise on her head, she also tired. The outcome of the events was unknown. Information about lot/batch number has been requested.

Other Meds:

Current Illness:

Date Died:

ID: 1000226
Sex: F
Age:
State: GA

Vax Date: 01/19/2021
Onset Date: 01/27/2021
Rec V Date: 02/04/2021
Hospital: Y

Lab Data:

Allergies:

Symptoms: volvulus; volvulus and needed surgery followed by further ischemia; This is a spontaneous report from a contactable physician. An 86-year-old female patient received her first single dose of BNT162B2 (Pfizer-BioNTech Covid-19 vaccine) intramuscularly on 19Jan2021 for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had no known allergies. The patient developed volvulus and needed surgery followed by further ischemia and at end of life. The events onset date reported as 27Jan2021. Patient had 3days hospitalization and died eventually. It was unknown if an autopsy was performed. Information about lot/batch number has been requested.; Sender's Comments: Very limited information was provided in this report. No relevant information regarding the clinical course of the events, the patient's underlying medical conditions were mentioned. Based on the information currently available, lacking any other alternative explanations as so far, the reported volvulus and Intestinal ischaemia are managed as related to COVID-19 vaccine, BNT162B2, for reporting purpose, only. 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 RA, IEC, as appropriate.; Reported Cause(s) of Death: volvulus; ischemia

Other Meds:

Current Illness:

ID: 1000227
Sex: M
Age:
State: CA

Vax Date: 01/23/2021
Onset Date: 01/24/2021
Rec V Date: 02/04/2021
Hospital: Y

Lab Data: Test Date: 20210124; Test Name: covid test (Nasal Swab); Test Result: Negative

Allergies:

Symptoms: heart attack; This is a spontaneous report from a contactable consumer (patient). A 67-year-old male patient received bnt162b2 (BNT162B2, lot # EL9263) at single dose at left arm on 23Jan2021 14:15 for Covid-19 immunisation. Medical history included hypertension, high cholesterol. No known allergies. The patient had not experienced Covid-19 prior vaccination. There were no concomitant medications. The patient had not received any other vaccines within 4 weeks prior to the BNT162B2 vaccine. On 24Jan2021 06:00, the morning after he received the COVID-19 vaccine, he had a heart attack. The patient was hospitalized for heart attack for 2 days and evet was considered life threatening. The doctor placed 2 stents in his arteries. The patient underwent lab tests and procedures which included Sars-cov-2 test: negative on 24Jan2021.

Other Meds:

Current Illness:

Date Died: 01/26/2021

ID: 1000228
Sex: M
Age:
State: NV

Vax Date: 01/21/2021
Onset Date: 01/21/2021
Rec V Date: 02/04/2021
Hospital:

Lab Data:

Allergies:

Symptoms: dead; Collapsed; bnt162b2 was given to patient with immunocompromised w/ reportable conditions; bnt162b2 was given to patient with immunocompromised w/ reportable conditions; This is a spontaneous report from a contactable nurse. A 40-year-old male patient receive first dose of bnt162b2 (Lot number: EK9231, Brand: Pfizer), intramuscular in left arm on 21Jan2021 15:15 at single dose for COVID-19 immunization. Medical history included immunocompromised w/ reportable conditions from an unknown date and unknown if ongoing, positive for Covid in September from Sep2020 to an unknown date. The patient's concomitant medications were not reported. The patient experienced dead, collapsed on 26Jan2021. Therapeutic measures were taken as a result of collapsed. The outcome of collapsed was unknown. The patient died on 26Jan2021. It was not reported if an autopsy was performed. Received Covid vaccine here on 21Jan2021, was at work on 26Jan2021 and collapsed, no known complaints at the time, CPR (cardiopulmonary resuscitation) was initiated immediately, transported to ER (Emergency room) and pronounced dead. Unknown if other vaccine in four weeks. The patient had COVID prior vaccination. Unknown If COVID tested post vaccination.; Sender's Comments: Based on the information currently provided, the patient was immunocompromised and had prior COVID infection. The death and syncope more likely are associated with the patient underlying medical conditions. More information such medical history, concomitant medications, treatment indication and event term details especially death cause and autopsy results are needed for fully medical assessment. 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.; Reported Cause(s) of Death: Dead

Other Meds:

Current Illness:

ID: 1000229
Sex: F
Age:
State: FL

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

Lab Data:

Allergies:

Symptoms: she had a pneumonia shot where kind of the same thing happened, she had red, bumped up and itchiness at the injection.; she had a pneumonia shot where kind of the same thing happened, she had red, bumped up and itchiness at the injection.; she had a pneumonia shot where kind of the same thing happened, she had red, bumped up and itchiness at the injection.; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received pneumococcal 13-val conj vac (dipht crm197 protein) (reported as PNEUMONIA SHOT), via an unspecified route of administration on an unspecified date at single dose for immunization. The patient medical history and concomitant medications were not reported. The patient had a pneumonia shot and she had red, bumped up and itchiness at the injection. She didn't remember if she was diagnosed with cellulitis as it was a long time ago and she had no NDC, Lot, or Expiry for the product. The outcome of the events was unknown. Pfizer is a marketing authorization holder of [Pneumococcal 13-Val Conj Vac (Dipht CRM197 Protein)] in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of [Pneumococcal 13-Val Conj Vac (Dipht CRM197 Protein)] has submitted the same report to the regulatory authorities. No follow-up attempts are needed; Information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1000230
Sex: F
Age:
State: NC

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

Lab Data:

Allergies:

Symptoms: Patient reports pain and loss of use of arm after receiving Prevnar13.; Patient reports pain and loss of use of arm after receiving Prevnar13; This is a spontaneous report from a contactable consumer (patient) communicated to Pfizer sales representative. A female patient of an unspecified age received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13, Solution for injection in pre-filled syringe), via an unspecified route of administration on an unspecified date at single dose for immunisation. The patient medical history was not reported and concomitant medications were not reported. The patient reported pain and loss of use of arm after receiving Prevnar13. She explains it was two to three years ago and she still does not have full range of motion in the arm and still has pain. Event took place after use of product. The event outcome was not recovered. No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1000231
Sex: F
Age:
State: TX

Vax Date: 01/20/2021
Onset Date: 01/25/2021
Rec V Date: 02/04/2021
Hospital: Y

Lab Data: Test Date: 20210125; Test Name: Nasal Swab; Test Result: Negative

Allergies:

Symptoms: currently receiving IVIG for Acute Inflammatory Demyelinating Neuropathy; This is a spontaneous report from a contactable physician report for self. This 41-year-old no pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140), at left arm on 20Jan2021 at single dose for COVID-19 immunization. Medical history included Breast cancer (remission, 15 years ago), GERD, Hyperlipidemia. Concomitant medication not reported. Patient previously received second dose of Gardasil vaccine on 16Dec2020 at left arm and first dose of BNT162B2 (lot number: EJ1685) on 30Dec2020 08:15 AM at left arm. Five days after 2nd covid vaccine (on 25Jan202021 01:00 PM), patient started experiencing excruciating pain along the plantar aspects of both feet. This, with numbness and tingling ascended upwards (in a matter of hours) to lower back and arms. Patient went to local emergency room and was later transferred to (Institute name) for higher level of care. She was currently receiving IVIG for Acute Inflammatory Demyelinating Neuropathy. This is a GBS-like illness. Very debilitating, due to pain. No motor deficits yet. Hoping the IVIG stops the Demyelinating process in its tracks. The events resulted in hospitalization for 6 days. Patient received Nasal Swab covid test date on 25Jan2021 with result of "Negative". The outcome of events was not recovered.; Sender's Comments: Based on temporal association, a possible contributory role of BNT162B2 cannot be completely excluded for reported event acute inflammatory demyelinating neuropathy. 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: 1000232
Sex: M
Age:
State:

Vax Date: 01/14/2021
Onset Date: 01/01/2021
Rec V Date: 02/04/2021
Hospital:

Lab Data:

Allergies:

Symptoms: On 14Jan2021, the patient received the second dose of BNT162B2 and the first dose on 28Dec2020; extreme blurriness in left eye; Nauseous; intense headache at the base of neck up to eye socket; This is a spontaneous report from a contactable consumer (reporting for himself). A 68-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EL8982), via an unspecified route of administration on 14Jan2021 at a single dose for COVID-19 immunization. Medical history and concomitant medications were none. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EL1284) on 28Dec2020 for COVID-19 immunization and experienced severe headache and was nauseous. The patient experienced extreme blurriness in left eye, nauseous, intense headache at the base of neck up to eye socket in Jan2021. On 14Jan2021, the patient received the second dose of BNT162B2 and the first dose on 28Dec2020. Therapeutic measures were taken as a result of extreme blurriness in left eye, nauseous, intense headache at the base of neck up to eye socket and included: ibuprofen 1000mg. The outcome of extreme blurriness in left eye, nauseous and on 14Jan2021, the patient received the second dose of BNT162B2 and the first dose on 28Dec2020 as unknown and of intense headache at the base of neck up to eye socket was recovered in Jan2021.

Other Meds:

Current Illness:

Date Died:

ID: 1000233
Sex: M
Age:
State:

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

Lab Data:

Allergies:

Symptoms: just died; This is a Spontaneous report from a Pfizer Sponsored Program from a contactable consumer. A male patient of an unspecified age received 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 just died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: just died

Other Meds:

Current Illness:

ID: 1000234
Sex: F
Age:
State:

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

Lab Data: Test Name: Purpureocillium lilacinum cultures; Test Result: Positive ; Test Name: Eye test; Result Unstructured Data: Examination of the right eye was unremarkable; Test Name: Eye test; Result Unstructured Data: preliminary corneal cultures on blood and Saboraud's agars revealed fungal elements; Test Name: Slit-lamp; Result Unstructured Data: central corneal infiltrate with feathery borders measuring 2.4 mm x 2.0 mm with an overlying epithelial defect; Test Name: Slit-lamp examination; Result Unstructured Data: Slit-lamp examination of the left eye revealed a central corneal infiltrate with feathery borders measuring 2.4 mm x 2.0 mm with an overlying epithelial defect with associated satellite lesions, 2+ stromal edema, and presence of keratic precipitates with hypopyon inferiorly.; Test Name: Visual acuity; Result Unstructured Data: was 20/20 in the right eye and 20/400 in the left eye

Allergies:

Symptoms: Purpureocillium lilacinum Keratitis; corneal ulcer; blurry vision; pain; photophobia of the affected eye; reactivation of herpes zoster dermatitis/of herpes zoster lesions on the flank; Initial information was received on 09-Nov-2020 regarding an unsolicited valid serious case from the other health care professional via a literature full article. This case involves a 64 year old female patient who had purpureocillium lilacinum keratitis (keratitis fungal), reactivation of herpes zoster dermatitis/of herpes zoster lesions on the flank (herpes zoster reactivation), blurry vision (vision blurred), eye pain, photophobia of the affected eye (photophobia) and corneal ulcer (ulcerative keratitis), while she received vaccines INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT]. The patient's past medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Herpes zoster and Herpes zoster. Patient endorsed a history of soft contact lens misuse, including periodic extended and overnight contact lens wear. She denied trauma or exposure to vegetable matter. On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination. On an unknown date, the patient developed a serious purpureocillium lilacinum keratitis (keratitis fungal), reactivation of herpes zoster dermatitis/of herpes zoster lesions on the flank (herpes zoster reactivation), blurry vision (vision blurred), eye pain, photophobia of the affected eye (photophobia) and corneal ulcer (ulcerative keratitis), unknown latency following the administration of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT]. These events was assessed as medically significant. On an unknown date, the patient developed a non serious reactivation of herpes zoster dermatitis/of herpes zoster lesions on the flank (herpes zoster reactivation) unknown latency following the administration of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT]. Relevant laboratory test results included: On an unknown date Purpureocilium lilacinum keratitis culture showed positive and slit-lamp examination showed left eye revealed a central corneal infiltrate with feathery borders measuring 2.4 mm x 2.0 mm with an overlying epithelial defect with associated satellite lesions, 2plus stromal edema, and presence of keratic precipitates with hypopyon inferiorly. On examination, the patient's best corrected visual acuity was 20/20 in the right eye and 20/400 in the left eye. Examination of the right eye was unremarkable Routine corneal scrapings were performed using blood, chocolate, Sabourads and non-nutrient agars, as well as thioglycolate broth. Empirical treatment with hourly fortified vancomycin and tobramycin was initiated, along with oral valacyclovir. Three days later, the preliminary corneal cultures on blood and Saborauds agars revealed fungal elements. Fortified antibiotics were decreased and the patient was started on hourly topical voriconazole. Final culture and speciation results indicated Purpureocillium lilacinum as the causative agent. After approximately 3 months of voriconazole monotherapy, the infiltrate regressed, leaving behind a partially light-blocking anterior stromal scar. The patient was treated with VANCOMYCIN (VANCOMYCIN) and TOBRAMYCIN (TOBRAMYCIN),along with oral valacyclovir 1 gram three times daily. The patients best corrected visual acuity improved to 20/25 in the left eye. At the time of reporting, the outcome of event was recovering. Information on lot number was requested for this case.; Sender's Comments: This case concerns a 64 year old female patient who had keratitis fungal, herpes zoster reactivation,vision blurred, eye pain, photophobia and ulcerative keratitis after vaccination with FLUZONE QUADRIVALENT. The time to onset is unknown. Additional information regarding medical history, condition at the time of vaccination, lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the suspect vaccine cannot be assessed.

Other Meds:

Current Illness: Herpes zoster dermatitis

ID: 1000235
Sex: F
Age:
State:

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

Lab Data: Test Name: temperature; Test Result: 103.6 {DF}; Result Unstructured Data: laying in bed with 103.6 temperature

Allergies:

Symptoms: laying in bed with 103.6 temperature; feels like she's dying; Initial information received on 24-Jan-2021 regarding an unsolicited valid non-serious case from consumer/non-health care professional. This case involved a female patient of unknown age who was laying in bed with 103.6 temperature (body temperature increased) and feels like she's dying (feeling abnormal), while she received vaccines INFLUENZA VACCINE. Medical history, past medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported. On an unknown date, the patient received INFLUENZA VACCINE [lot number: unknown and expiration date: unknown] at an unknown dose via unknown route in an unknown administration site for prophylactic vaccination. On an unknown date, (latency: unknown) patient who was laying in bed with 103.6 temperature (body temperature increased) and feels like she's dying (feeling abnormal) following the administration of suspect vaccine. It was not reported if the patient received a corrective treatment. Outcome of the events were unknown. There will be no information available regarding batch number in this case.

Other Meds:

Current Illness:

ID: 1000236
Sex: F
Age:
State:

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

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

Allergies:

Symptoms: covid; almost died; Initial information received on 26-Jan-2021 regarding an unsolicited valid serious media case received from a consumer or non-healthcare professional. This case involves a female patient (age not reported) who developed Covid (covid-19) and almost died (near death experience), while she received INFLUENZA VACCINE. The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number and expiry date not reported via an unknown route in an unknown administration site for prophylactic vaccination. On an unknown date, the patient developed Covid (covid-19) and almost died (near death experience) (unknown latency) following the administration of INFLUENZA VACCINE. These events were assessed as medically significant. It was reported that reporter's sister got the flu shot still got covid and almost died. Flu shot did not helped her one bit. Relevant laboratory test results included: SARS-CoV-2 test - On an unknown date: Positive It was not reported if the patient received a corrective treatment. At the time of reporting, the outcome was unknown for events. Information on the batch number was requested.; Sender's Comments: This poorly documented media case concerns a female patient (age not reported) who developed covid-19 during the pandemic and reportedly almost died after vaccination with INFLUENZA VACCINE (unknown manufacturer). The time to onset was unknown. Moreover, patient's medical condition at the time of vaccination and lab tests ruling out predisposing etiologies were not reported. Based upon the reported information, the role of the suspect vaccine cannot be assessed.

Other Meds:

Current Illness:

ID: 1000237
Sex: U
Age:
State:

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

Lab Data:

Allergies:

Symptoms: Every time patient ever got flu shot ,still got the flu.Rarely when patient didnt; Initial information received on 21-Jan-2021 regarding an unsolicited valid non-serious case from a consumer/non-health care professional. This case involves patient (unknown demography) who every time ever got flu (influenza),after receiving INFLUENZA VACCINE. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiration date not reported) via unknown route in unknown administration site for prophylactic vaccination. On an unknown date, the patient every time had non-serious flu (influenza, unknown latency) after getting INFLUENZA VACCINE. Also reported that the patient had it rarely when he/she did not (As reported in the source by the reporter: "Every time I ever got flu shot I still got the flu...Rarely when I didn't"). No laboratory data reported. It was not reported if the patient received a corrective treatment. At the time of reporting, the outcome was not reported for the reported event. There will be no information on the batch number for this case.

Other Meds:

Current Illness:

ID: 1000238
Sex: U
Age:
State: WI

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

Lab Data:

Allergies:

Symptoms: swelling; Initial information received on 22-Jan-2021 regarding an unsolicited valid non-serious case received from a physician. This case involves adult patient of unknown demographics who experienced swelling, while the patient received INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE]. The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was not reported. On an unknown date, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (lot number and expiration date were not reported) via unknown route in unknown administration site for prophylactic vaccination. On an unknown date, the patient developed a non-serious swelling following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. No laboratory test was reported. It was not reported if the patient received a corrective treatment. The patient was reported as unknown.

Other Meds:

Current Illness:

ID: 1000239
Sex: U
Age:
State:

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

Lab Data:

Allergies:

Symptoms: got severely sick; Initial information was received on 25-Jan-2021 regarding an unsolicited valid non-serious social media case from a consumer or non-health care professional (patient). This case involves patient (unknown demography) who got severely sick (illness), while the patient received INFLUENZA VACCINE [Flu shot]. It is unknown if the patient had any medical history, concomitant disease or risk factor. Medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination. On an unknown date, the patient got severely sick (illness) (non-serious) unknown latency following the administration of INFLUENZA VACCINE. It was reported that, patient got flu shot got one 20 years, got severely sick. Never had one since, never had the flu. Will never get one again. Details of laboratory data were not reported. It was not reported if the patient received any corrective treatment. At the time of report, the outcome was unknown for the event. There will be no information available on the batch number for this case.

Other Meds:

Current Illness:

ID: 1000240
Sex: U
Age:
State:

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

Lab Data:

Allergies:

Symptoms: got severely sick; Initial information was received on 25-Jan-2021 regarding an unsolicited valid non-serious social media case from a consumer or non-health care professional (patient). This case involves patient (unknown demography) who got severely sick (illness), while the patient received INFLUENZA VACCINE [Flu shot]. It is unknown if the patient had any medical history, concomitant disease or risk factor. Medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination. On an unknown date, the patient got severely sick (illness) (non-serious) unknown latency following the administration of INFLUENZA VACCINE. It was reported that, patient got flu shot got one 20 years, got severely sick. Never had one since, never had the flu. Will never get one again. It is unknown if the patient experienced any additional symptoms/events. Details of laboratory data were not reported. It was not reported if the patient received any corrective treatment. At the time of report, the outcome was unknown for the event. There will be no information available on the batch number for this case.

Other Meds:

Current Illness:

ID: 1000241
Sex: U
Age:
State: FL

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

Lab Data:

Allergies:

Symptoms: patient was administered with second dose of fluzone quadrivalent 18 days after initial dose with no reported adverse event; Initial information was received on 14-Jan-2021 regarding an unsolicited valid non-serious case from a other health professional. This case involves a 4-year-old patient (gender unknown) who was administered with second dose of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] 18 days after initial dose with no reported adverse event (lot number and expiry date not reported) via an unknown route at an unknown administration site on an unknown date for prophylactic vaccination, (inappropriate schedule of product administration). Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided. It was an actual medication error due to inappropriate schedule of vaccine administered. (latency: unknown). At the time of report, no adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. There will be no information available on the lot number for this case.

Other Meds:

Current Illness:

ID: 1000242
Sex: F
Age:
State: IL

Vax Date: 10/22/2009
Onset Date:
Rec V Date: 02/04/2021
Hospital:

Lab Data: Test Name: Allergy test; Result Unstructured Data: has no allergies

Allergies:

Symptoms: lips and eyes swelled up; lips and eyes swelled up; flu symptoms; Initial information received on 19-Jan-2021 regarding an unsolicited valid non-serious case from consumer/non-health care professional. This case involved a female patient of unknown age who experienced lips and eyes swelled up (lip swelling and eye swelling) and flu symptoms (influenza), while she received vaccines INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV]. Medical history, past medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported. On 22-Oct-2009, the patient received INFLUENZA QUADRIVAL A-B VACCINE [lot number: unknown and expiration date: unknown] at an unknown dose via unknown route in an unknown administration site for prophylactic vaccination. On an unknown date in 2009, (latency: unknown) patient who experienced lips and eyes swelled up (lip swelling and eye swelling) and flu symptoms (influenza) following the administration of suspect vaccine. Relevant laboratory test results included: Allergy test - On an unknown date: [had no allergies]. It was not reported if the patient received a corrective treatment. Outcome of the events were unknown. There will be no information available regarding batch number in this case.

Other Meds:

Current Illness:

ID: 1000243
Sex: U
Age:
State: NE

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

Lab Data:

Allergies:

Symptoms: received the doses Fluzone High-Dose Quadrivalent one month apart due to an oversite issue, no AE; Initial information received on 19-Jan-2021 regarding an unsolicited valid non-serious case from a pharmacist. This case involves patient (unknown demographics) who received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (lot number and expiration date not reported) one month apart due to an oversite issue via unknown route in unknown administration site for prophylactic vaccination on an unknown dates (extra dose administered). Medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. This was an actual medication error due to extra dose administered [latency was same day]. At the time of reporting, no adverse event was reported to the patient. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. There will be no information on the batch number for this case.

Other Meds:

Current Illness:

ID: 1000244
Sex: F
Age: 63
State: PA

Vax Date: 01/19/2021
Onset Date: 01/19/2021
Rec V Date: 02/04/2021
Hospital:

Lab Data:

Allergies:

Symptoms: administered 0.5 ml of Daptacel in the left deltoid by SS, the vaccine had expired prior to the administration with no AE; Initial information regarding this unsolicited valid non-serious case This case involves a 63 year old female patient who received a 0.5 ml dose of vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (lot: U6101, expiry date: 23-Oct-2020), via intramuscular route at left deltiod, on 19-Jan-2021 (expired product administered). The patient's medical history, medical treatments, vaccinations, concomitant medication and family history were not provided. It was an actual medication error due to the expired product administered. At the time of reporting, the patient had no adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.

Other Meds:

Current Illness:

ID: 1000245
Sex: F
Age: 12
State: TN

Vax Date: 01/07/2021
Onset Date: 01/07/2021
Rec V Date: 02/04/2021
Hospital:

Lab Data:

Allergies:

Symptoms: patient recived vaccine expired on 26-Aug-2020/no AE; Initial information was received on 20-Jan-2021 regarding an unsolicited valid non-serious case received from a other health professional. This case involves 12-year-old female patient who received a forth dose of 0.5 ml of IPV (VERO) [IPOL] vaccine which was expired 26-Aug-2020 [lot number: R1D972M] via an intramuscular route in the left deltoid on 07-Jan-2020 for prophylactic vaccination (expired product administered). Medical history, medical treatment, vaccination, concomitant medications and family history were not provided. It was an actual medication error due to expired vaccine used. (latency: at the time of vaccination) At the time of report, no adverse event was reported. It was reported that, normally they(reporter) would not have kept this vaccine for more than 28 days and they do not have an explanation on how this happened. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.

Other Meds:

Current Illness:

ID: 1000246
Sex: M
Age: 0
State: TX

Vax Date: 01/21/2021
Onset Date: 01/21/2021
Rec V Date: 02/04/2021
Hospital:

Lab Data:

Allergies:

Symptoms: the powder component of the Pentacel was reconstituted with sterile water instead of the liquid that came with the powder and was then administered to the infant, with no reported adverse event; Initial information received on 22-Jan-2021 regarding an unsolicited valid non-serious case received from other health professional. This case involves a 4-months-old male patient for whom it was reported that the powder component of the pentacel was reconstituted with sterile water instead of the liquid that came with the powder and was then administered to the infant, with no reported adverse event (product preparation error), while he received DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL]. The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included pneumococcal vaccine conj 7v (CRM197) (Prevnar). On 21-Jan-2021, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot number: UJ337AAA and expiration date: 05-Jul-2021) via unknown route in unknown administration site for prophylactic vaccination. It was a case of medication error due to product preparation error. (Latency: same day of vaccination). It was reported that the powder component of the pentacel was reconstituted with sterile water instead of the liquid that came with the powder and was then administered to the infant. At the time of report, no adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. There will be no information available on the batch number for this case.

Other Meds: PREVNAR

Current Illness:

ID: 1000381
Sex: F
Age: 20
State: PA

Vax Date: 02/03/2021
Onset Date: 02/04/2021
Rec V Date: 02/04/2021
Hospital:

Lab Data: None this far

Allergies: Celiac Disease Allergies to Regalan, Benadryl

Symptoms: Left arm was slightly sore last night (day of injection). Provided 400 mg Advil. Woke up at 5:30 am with a 102 fever, headache, queasiness, and all over body ache. Provided 400 mg Advil as of 6:00 am and monitoring.

Other Meds: Inderal LA - 60 mg/day Multivitamin Miralax - 17 grams/day

Current Illness: None

ID: 1000385
Sex: F
Age: 69
State: FL

Vax Date: 02/03/2021
Onset Date: 02/03/2021
Rec V Date: 02/04/2021
Hospital:

Lab Data:

Allergies: n/a

Symptoms: Client felt nauseous and had palpitation. Paramedics assess client on site. Client was released at 10.

Other Meds: Client unsure of medications currently taking.

Current Illness:

ID: 1000388
Sex: M
Age: 30
State: SD

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

Lab Data: cbc, cmp

Allergies:

Symptoms: Fever, tachycardia, hypotension, diffuse urticaria

Other Meds:

Current Illness:

ID: 1000392
Sex: U
Age: 35
State: IL

Vax Date: 01/19/2021
Onset Date: 01/20/2021
Rec V Date: 02/04/2021
Hospital:

Lab Data:

Allergies:

Symptoms: SEVERE FEVER , WEAKNESS , AND ACHES THAT LASTED ABOUT 20 HOURS.

Other Meds:

Current Illness:

ID: 1000394
Sex: F
Age:
State: IN

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

Lab Data:

Allergies: None

Symptoms: Chills, temp 101

Other Meds: Baby asa,bioten,allergy pill,valsartan,melixicam,alendronate sodium.

Current Illness: None

ID: 1000398
Sex: F
Age: 42
State:

Vax Date: 01/30/2021
Onset Date: 02/03/2021
Rec V Date: 02/04/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Diarrhoea

Other Meds: Levothyroxine

Current Illness:

ID: 1000400
Sex: M
Age: 48
State: IN

Vax Date: 02/01/2021
Onset Date: 02/03/2021
Rec V Date: 02/04/2021
Hospital:

Lab Data:

Allergies: None

Symptoms: Swollen/painful lymph nodes behind L collar bone and in L arm

Other Meds: Aleve

Current Illness: None

ID: 1000402
Sex: F
Age: 35
State: NY

Vax Date: 02/03/2021
Onset Date: 02/04/2021
Rec V Date: 02/04/2021
Hospital:

Lab Data:

Allergies: Reglan

Symptoms: Fever, muscle aches, headache

Other Meds: Metoprolol, multivitamin, iron, vitamin c, biotin, collagen, vitamin d, magnesium

Current Illness: None

ID: 1000405
Sex: F
Age: 32
State: IA

Vax Date: 12/30/2020
Onset Date: 12/30/2020
Rec V Date: 02/04/2021
Hospital:

Lab Data: did not seek medical help

Allergies: NKA

Symptoms: Face and arm on the side COVID vaccine given started tingling and got warm right away then had numbness and tingling after. For the first 15 mins also had heart palpitations. 12 hours later after waking up face sensation was dull and improved over the night.

Other Meds: multivitamin, vitamin C, Vitamin D

Current Illness: none

Total 2021 VAERS Injuries: 134,999

Page last modified: 14 December 2021 10:42pm