VAERS 2021 Database www.vaers.hhs.gov

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

Total Manufacturer
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: 0934934
Sex: F
Age:
State: FL

Vax Date: 12/16/2020
Onset Date: 12/18/2020
Rec V Date: 01/11/2021
Hospital:

Lab Data:

Allergies:

Symptoms: I was in a low disease state of SLE, 2 days after injection i had a severe flare of lupus requiring steroids; This is a spontaneous report from a contactable other Hcp (patient). This 36-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EH9899), intramuscularly on 16Dec2020 13:30 at single dose in Arm left for COVID-19 immunisation. Facility where the most recent COVID-19 vaccine was administered was Hospital. Medical history included systemic lupus erythematosus (SLE) and in remission. No Pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient did not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.Concomitant medication received within 2 weeks of vaccination included hydroxychloroquine, topiramate (TROKENDI), prucalopride succinate (MOTEGRITY). The patient was in a low disease state of SLE, 2 days after injection and had a severe flare of lupus requiring steroids on 18Dec2020. The adverse event result in Doctor or other healthcare professional office/clinic visit. Steroids received as treatment. The outcome was recovering. The events were assessed as non-serious; 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 Systemic lupus erythematosus syndrome aggravated cannot be totally 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: ; TROKENDI; MOTEGRITY

Current Illness:

ID: 0934935
Sex: F
Age: 28
State: CA

Vax Date: 01/07/2021
Onset Date: 01/07/2021
Rec V Date: 01/11/2021
Hospital:

Lab Data:

Allergies: Allergy to Pork and pork protein

Symptoms: Sore arm, bruise at injection site, fatigue - all lasting 3 days

Other Meds: None

Current Illness: none

ID: 0934936
Sex: F
Age:
State: IL

Vax Date: 12/31/2020
Onset Date: 12/31/2020
Rec V Date: 01/11/2021
Hospital:

Lab Data:

Allergies:

Symptoms: experiencing an allergic reaction; Hives all over her face and neck/hives on face and neck; This is a spontaneous report from a contactable Physician (patient). A 30-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL0140, Expiry Date: 31Mar2021) via an unspecified route of administration in left upper arm on 31Dec2020 13:25 at single dose for COVID-19 immunisation. Medical history included crohn's disease from Jul2005 and ongoing, ongoing psoriasis, gastrooesophageal reflux disease (GERD), hand tremor. Concomitant medication included ongoing infliximab (REMICADE) for Crohn's, ongoing esomeprazole sodium (NEXIUM) for GERD, ongoing propranolol for hand tremor, copatsol topical steroid for Psoriasis, ongoing Multivitamin, ongoing vitamin B complex (B COMPLEX), ongoing biotin, ongoing iron, ongoing Calcium/Vitamin D, ongoing curcuma longa (TURMERIC). The patient had an allergic reaction after getting the COVID vaccine. She had an allergic reaction after getting the vaccine. She had hives all over her face and neck. She already had a Medrol Dose Pack at home and some Benadryl. She contacted her doctor who prescribed an Epi Pen for her, but she did not have to use the Epi Pen. She stated she used the Benadryl for three days. She started to get hives all over her face and neck the same date she got the vaccine. It started 2 hours after she got the vaccine (31Dec2020 15:25). She confirmed this was the first dose of the COVID Vaccine. She asked that if it is safe to take the second dose after experiencing an allergic reaction to the first dose. Symptoms include hives on face and neck. Patient had no trouble breathing. Took steroids and Benadryl for 3 days or until symptoms have been managed. No any of the events require a visit to emergency room. Reporter seriousness for hives all over her face and neck was reported as medically significant. Events outcome was recovered on 03Jan2021.; 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 events Allergic reaction and Hives cannot be totally 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: REMICADE; NEXIUM [ESOMEPRAZOLE SODIUM]; PROPANOLOL [PROPRANOLOL]; B COMPLEX [VITAMIN B COMPLEX]; ; ; ; TURMERIC [CURCUMA LONGA]; MULTIVITAMIN [ASCORBIC ACID;BIOTIN;CALCIUM PANTOTHENATE;CYANOCOBALAMIN;FOLIC ACID;NICOTINIC ACID;PYR

Current Illness: Crohn's disease; Psoriasis

ID: 0934937
Sex: F
Age:
State: NM

Vax Date: 12/18/2020
Onset Date: 12/18/2020
Rec V Date: 01/11/2021
Hospital:

Lab Data: Test Name: temperature; Result Unstructured Data: Test Result:Unknown result

Allergies:

Symptoms: blasting headaches; chills all night; dry heaving all night; Nausea; no fever but her skin felt hot; sore left arm; This is a spontaneous report from a contactable nurse for herself. This 64-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscular on 18Dec2020 at single dose on left upper arm (lot: EKS730), via an unspecified route of administration on 05Jan2021 14:30 at single dose (lot: EL1284 or EKI284) for COVID-19 immunisation. Medical history and concomitant medications were none. The patient did not have anything with the first shot except a sore left arm on 18Dec2020. She stated that if she lays on left side it is sore. The patient had the sore left arm both times that she got the vaccine. She got second dose of vaccine on 05Jan2021 at 2:30pm and had a blasting headache and just had chills that went away about hour ago on 05Jan2021. She did not have a fever but her skin felt hot on 05Jan2021. She stated that she had dry heaves on 05Jan2021. The patient started that she had a blasting headache within a few hours of the vaccine and it gradually got worst by the time she went to bed. Stated that the chills and dry heaves started then and throughout the night. The chills stopped an hour before she got up. Stated that she went to check her temperature and did not have a fever despite having chills and her skin feeling hot. Stated that nausea started about 10 at night on 05Jan2021. Seriousness for blasting headache, chills and dry heaves was disabling, for nausea was medically significant, for other events was non-serious. The patient took Ibuprofen for the headache. Stated that she was going to try to drink something. The outcome of sore left arm was not recovered; of chills was recovered on 06Jan2021. The outcome of other events was recovering. The causality for blasting headache, chills, dry heaves, nausea and skin felt hot was related (Source of assessment: Primary Source Reporter, Method of assessment: Agency Information on the batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the headache, chills, dry heaves and other reported events due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Other Meds:

Current Illness:

ID: 0934938
Sex: F
Age: 25
State:

Vax Date: 01/09/2021
Onset Date: 01/09/2021
Rec V Date: 01/11/2021
Hospital:

Lab Data:

Allergies:

Symptoms: called in sick to work. not feeling well.

Other Meds:

Current Illness:

ID: 0934939
Sex: F
Age:
State: MI

Vax Date: 12/18/2020
Onset Date:
Rec V Date: 01/11/2021
Hospital:

Lab Data: Test Date: 20210106; Test Name: COVID test rapid (Nasal Swab); Test Result: Negative

Allergies:

Symptoms: severe muscle pain, diagnosis of polymyalgia rheumatica; This is a spontaneous report from a contactable other HCP (patient). A 53-year-old female patient received the first dose of BNT162b2 (Lot/batch number and Expiration date were not provided), at the age of 53-year-old, via an unspecified route of administration at right arm on 18Dec2020 08:30 at single dose for covid-19 immunization. Medical history included hypertension (htn), allergies: penicillin. Concomitant medication included cefatrizine propyleneglycolate (CEFTIN), lisinopril, levothyroxine sodium (SYNTHROID). The patient experienced severe muscle pain, diagnosis of polymyalgia rheumatica on an unspecified date. The patient was not pregnant at the time of vaccination. The patient underwent lab tests and procedures which included COVID test rapid (Nasal Swab): negative on 06Jan2021. The outcome of the event was unknown. Information on the lot/batch number has been requested.; Sender's Comments: A possible contributory effect of suspect drug BNT162B2 on reported event 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: CEFTIN [CEFATRIZINE PROPYLENEGLYCOLATE]; ; SYNTHROID

Current Illness:

ID: 0934940
Sex: F
Age:
State: TX

Vax Date: 12/18/2020
Onset Date: 12/19/2020
Rec V Date: 01/11/2021
Hospital:

Lab Data: Test Date: 20201226; Test Name: Fever; Result Unstructured Data: Test Result:103 degree; Test Date: 20201230; Test Name: Fever; Result Unstructured Data: Test Result:broke; Test Date: 20201228; Test Name: Covid test; Test Result: Negative ; Comments: She got tested for Covid and it was negative.

Allergies:

Symptoms: shaking; weak; cough; shortness of breath; very ill/ sick; horrible chills; I had a 103 degree fever for 4 days, horrible chills that were just debilitating; ached everywhere/ severe aches; site soreness; This is a spontaneous report from a contactable nurse (patient). A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EH9899) via an unspecified route of administration at left upper arm on 18Dec2020 at single dose for COVID-19 immunization. Medical history included auto immune problems, diabetes, thyroid condition, all ongoing since age 28; pemphigusvulgarism since Sep2020 and ongoing. No concomitant medications. Patient is a frontline worker. She received the vaccine on 18Dec2020 at (Name) where she works. 9 days later she got very ill. she didn't know if it's unrelated. She wanted to know if there is anything she need to be watching out for in order to get her second vaccine on Friday. She was so sick and she did have some autoimmune problems. She was really healthy. On 26Dec2020, she had a 103 degree fever for 4 days, horrible chills that were just debilitating. She was just shaking. She ached everywhere, she had severe aches since 26Dec2020. She got tested for Covid and it was negative on 28Dec2020, she had no cough and no vomit. She stayed in bed and drank lots of fluids and toughed it out. By New Year's Day (reported as 30Dec2020) her fever broke but she was so weak and didn't work. She was back at work now. Also, she experienced site soreness from the injection since 19Dec2020. She did have a cough or any shortness of breath. She felt awful. She had recovered. She was just a little nervous because everything she read said the reaction was more severe with second injection. She planned on getting the second shot. She would have a repeat Covid test on 07Jan2020. Reporter seriousness for fever 103: Medically significant. Reporter seriousness for severe aches: Medically significant. Reporter considered the causality of the event site soreness was related with bnt162b2, of the events fever 103 and severe aches was unknown. The outcome of the event fever was recovered on 30Dec2020, of event ache was recovered on 31Dec2020, of event chills was recovering, of event vaccination site pain was recovered on an unspecified date in Dec2020, of events cough and shortness of breath was recovered on an unspecified date.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the fever, pain and other reported events due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Other Meds:

Current Illness: Autoimmune disorder (since age 28); Diabetes (since age 28); Pemphigus vulgaris; Thyroid disorder (since age 28)

ID: 0934941
Sex: F
Age: 49
State: MA

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

Lab Data:

Allergies: no

Symptoms: Woke with chills, shaking, fever( up to 103) increased hart rate O2 sat between 92-95%, Symptoms lasted intermittently from 10:30 pm 1/5/21 until 0500 am 1/6/21. Continued with low grade fever on 1/6/21, fever resolved 1/7/21. Continued with episodes of increased heart rate baseline 70"s, intermittently up to 100-130.1/8/21 noted a few episodes of increase heart rate 100-120 lasting for only a few minutes.

Other Meds: no

Current Illness: no

ID: 0934942
Sex: M
Age:
State: FL

Vax Date: 01/03/2020
Onset Date: 01/03/2020
Rec V Date: 01/11/2021
Hospital:

Lab Data:

Allergies:

Symptoms: (doctor) was not sure whether or not he might get a staph infection, a viral infection; (doctor) was not sure whether or not he might get a staph infection, a viral infection; thought he had a mosquito bite; area on the opposite side of his body, on the left hand side, he noticed that there were several small pustules; the area was raised, it was red, it was warm; Pain; extremely uncomfortable; It was very, very itchy and the area felt like it got itself swollen; It was very, very itchy and the area felt like it got itself swollen; irritation; Initially an area under his left arm which was very swollen it appeared to be filled with fluid of some type/thought it was edema/now had it under his right arm, it's probably impacting lymph system; This is a spontaneous report from a contactable consumer (patient wife). A male patient of an unspecified age started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EH9899, expiration date not reported), via an unspecified route of administration on 03Jan2020 16:00, at a single dose for Covid-19 immunization. Medical history included heart bypass 15 years ago and some orthopedic problems. The patient's concomitant medications were not reported. The patient previously took codeine and epinephrine experienced sensitivity. On 03Jan2020, the patient had an injection the Pfizer vaccine in county (not clarified further) (place name withheld) which is the (place name withheld) area on Sunday at approximately 4:00 PM EST. He has no significant medical problems other than the prior history of, he had heart bypass 15 years ago and some orthopedic problems, but nothing else other than that. She had never had any adverse reactions to any medications although he has, he shouldn't say, he does have a sensitivity to Codeine which he reported and Epinephrine which he had a sensitivity to also. He got the vaccine after waiting three and half hours in line and they went off, last night that would be Sunday night, several hours later he noticed an odd sensation and did not really take a look at it, he thought he had a mosquito bite perhaps as they live in (place name withheld) and they live in the land that has lots of mosquito, so he didn't pay too much attention to it. Approximately four hours after the injection, he was going to go to bed and removed his shirt and found that the area on the opposite side of his body, on the left hand side he noticed that there were several small pustules, the area was raised it was red it was warm, it was on the opposite side under his arm on his chest he was extremely uncomfortable. It was very, very itchy and the area felt like it got itself swollen and he shared with his wife, the wife suggested that he contact the physician of course he didn't contact, his primary physician said he can see a dermatologist and sent images and yesterday he went to see a dermatologist, so prophylactically he took the 25 mg of diphenhydramine hydrochloride (BENADRYL) and also 2 acetaminophen (EXTRA STRENGTH TYLENOL) and he treated the pain and itching with ice. He slept with an ice bag and woke up just in morning and in New Year they were able to see a dermatologist, he thought it was dermatological. He was concerned but not overly concerned with the area pretty swollen. He saw a dermatologist yesterday, and gave him a topical treatment, the dermatologist gave him three different, naproxene (NAPROSYN), the other one is Triamcinolone Acetonide cream now the irritation he got the MUPIROCIN ointment now as the dermatoligist told him to do, continue what he was doing as he was comfortable, The dermatologist took some specimens from the pustules and send them to lab and she (doctor) is not sure whether or not he might get a staph infection, a viral infection he was not sure. Initially there was an area under his left arm which is very swollen it appeared to be filled with fluid of some type, he was not sure what was it. He thought it was edema but when he popped it, it felt very much like fluid not like blood but it is some type of fluid filled area most likely his wife said the size are greater and less that it was yesterday and that seems to go down over the last night but not all the way it's decreased by what 20%, 30%, 40% he can't tell, alright 50% but now he has it under under right arm, it's probably impacting his lymph system and he put a call into his cardiologist. So he was asking now what does he do. The outcome of the events were unknown.

Other Meds:

Current Illness:

ID: 0934943
Sex: F
Age:
State: MO

Vax Date: 01/05/2021
Onset Date: 01/06/2021
Rec V Date: 01/11/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Her arm is a little sore; the tissue paper is red after wiping her anal area/ reddish looking poop/ there are pieces of blood or something is different; This is a spontaneous report from a contactable other Health Professional (patient). A 75-year-old female patient receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL0142), via an unspecified route of administration on 05Jan2021 at single dose for covid-19 immunization, also reported as for work. Medical history included ulcer (15 to 20 years before 06Jan2021). Concomitant medication included prasugrel from Apr2020 and ongoing as blood thinner, acetylsalicylic acid, ascorbic acid (ASPIRIN) from Apr2020 and ongoing as blood thinner. The patient went to the bathroom in the morning 06Jan2021, she had to poop. When she wiped, it was reddish looking. The patient stated her stool color was normal, but the tissue paper is red after wiping her anal area. At first she thought hm oh well. Then she had been to the bathroom a couple of times 06Jan2021, and that the same thing happened. She had never experienced that before. It seems to her that there were pieces of blood or something was different. She wasn't hurting or anything. She was not weak or anything at this time. Her arm was a little sore, but she expected that. She was concerned about the color. She worked in the mammography department. She didn't have a prescribing doctor. She got it at work. She had noticed a difference of color in her poop. It had been the same all day. The outcome of the reddish poop was not recovered, of sore arm was unknown. The patient asked would the vaccine cause rectal blood upon wiping after defecation?; Sender's Comments: Reported blood in stool is considered intercurrent and unrelated to BNT162B2. 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: ; ASPIRIN [ACETYLSALICYLIC ACID;ASCORBIC ACID]

Current Illness:

ID: 0934945
Sex: F
Age: 60
State: WI

Vax Date: 12/30/2020
Onset Date: 01/06/2021
Rec V Date: 01/11/2021
Hospital:

Lab Data:

Allergies: Doxycycline

Symptoms: Red, swollen around injection site and now on 1-11-21 red ring around injection site.

Other Meds: Creon, sertraline, omeprazole, topiramate, zyrtec. Biotin, vitamin d

Current Illness: No

ID: 0934946
Sex: F
Age:
State: IN

Vax Date: 12/23/2020
Onset Date: 01/02/2021
Rec V Date: 01/11/2021
Hospital:

Lab Data: Test Date: 20210106; Test Name: x-rays; Result Unstructured Data: Test Result:Unknown results; Comments: they were awaiting the X-rays

Allergies:

Symptoms: Joint pain /felt like it was worsening joint pain; just severe pain to where she couldn't walk; This is a spontaneous report from a contactable Other HCP. A 70-year-old female patient received BNT162B2(Lot Number: ET1685), via an unspecified route of administration at Deltoid Left on 23Dec2020 08:00 at the 70 years old at single dose for COVID-19 immunization. The medical history included rheumatoid arthritis. The concomitant medications were none. The patient received the shot on 23Dec2020 and experienced Joint pain afterward on 02Jan2021. The patient did have rheumatoid arthritis so there was that. The patient felt like it was worsening joint pain on 02Jan2021. She has had no fever, just severe pain to where she couldn't walk on 02Jan2021. The joint pain has gotten worse and it has gotten to where she is going to advise her not to take the second shot. The Reporter assessed the seriousness for the events was Disabling. The events did not require a visit to Emergency Room but required a Physician Office visit on 06Jan2021. The patient received a steroid injection on 06Jan2021. There was none History of all previous immunization with the Pfizer vaccine considered as suspect. There was none Additional Vaccines Administered on Same Date of the Pfizer Suspect. There was no Prior Vaccinations within 4 weeks. The patient underwent lab tests and procedures, which included x-rays on 06Jan2021: unknown results (they were awaiting the X-rays). The outcome of the events was not recovered. The information on the batch number has been requested.; Sender's Comments: Based on the available information the events worsening joint pain and walking difficulty are attributed to underlying Rheumatoid arthritis; however, based on a compatible temporal association, contributory role of BNT162B2 vaccine to events occurrence cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Other Meds:

Current Illness:

ID: 0934947
Sex: F
Age:
State: NY

Vax Date: 01/03/2021
Onset Date: 01/03/2021
Rec V Date: 01/11/2021
Hospital:

Lab Data:

Allergies:

Symptoms: it was debilitating for her at work; It even hurts to move the right eye in one direction and hurts to speak, the pain was so bad.; pain in right leg and bottom sole of right foot; hurts to speak; numbness right upper side of lip; pins and needle feeling right upper quadrant of face; pain and dull aching right upper side of face; right hand numbness, wasn't able to feel anything; generalized headache; generalized muscle weakness and pain; generalized muscle weakness and pain; This is a spontaneous report from a contactable other hcp (patient). A 31-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 03Jan2021 at single dose in deltoid right for covid-19 immunization. There were no medical history or concomitant medications. The patient received the vaccine on 03Jan2021 and within 15 minutes had a generalized headache. Later that night she had generalized muscle weakness and pain, but really didn't think too much about it. The next day at work (04Jan2021), she had numbness on the right upper side of her lip and a pins and needle feeling in the right upper quadrant of the face. Had a lot of pain in the area as well on the right upper side of the face as well as a dull aching pain that lasted for hours. Later that day when using the computer and she was trying to reach for her mouse she noticed her right hand wasn't able to feel anything and that lasted about 20-25 minutes. Kept slapping the mouse with her hand, but could not feel anything, her hand went numb. Yesterday (05Jan2021), she had the same pins and needle feeling in the same area of the face and that dull achy feeling and it occurred for hours and it was very kind of debilitating for her at work. Later that night she had pain in her right leg and felt the same way, that very severe achiness, which was the pins and needles feeling up and down the leg and underneath the right foot. All these symptoms tend to be on her right side and it definitely lasted for hours. It started about 1 and didn't end until 6-7pm. It even hurts to move the right eye in one direction and hurts to speak, the pain was so bad. This morning (06Jan2021) she had to call out of work because at 3am the generalized headache, pain was unbearable. She was still experiencing the pain in right leg and bottom sole of right foot. She did not receive any vaccines the same day or 4 weeks prior. No problems with vaccines in past. She had made an appointment with a neurologist and will have a MRI done on Friday, 08Jan2021. No further details provided. All events required a visit to physician office. All events were reported as serious per medically significant. The outcome of all events was not resolved. The reporter considered all events were related to the vaccine. Information about Lot/Batch number has been requested.; Sender's Comments: Based on a compatible temporal relationship, causality between reported events and BNT162B2 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: 0934948
Sex: F
Age: 37
State: TN

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

Lab Data:

Allergies: None

Symptoms: Fever, malaise, sore muscles, nausea, vomiting

Other Meds: None

Current Illness: None

ID: 0934949
Sex: F
Age:
State: NC

Vax Date: 12/31/2020
Onset Date: 01/01/2021
Rec V Date: 01/11/2021
Hospital:

Lab Data:

Allergies:

Symptoms: soreness/The pain radiates down to her left elbow and also goes up the neck; The pain radiates down to her left elbow and also goes up the neck; The pain radiates down to her left elbow and also goes up the neck; This is a spontaneous report from contactable other HCP (patient' husband). A 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK9231), via an unspecified route of administration on 31Dec2020 at single dose for COVID-19 immunization. Medical history reported as none. No concomitant medications. The patient had a whole lot of soreness on 01Jan2021 and it was not getting any better. His wife had called her health care provider. She had an appointment in several days. The pain radiates down to her left elbow and also goes up the neck in Jan2021. The reporter seriousness for soreness: Medically significant. The outcome of event pain was not recovered. The outcome of rest events was unknown.; Sender's Comments: Based on a compatible temporal relationship, causality between event pain and BNT162B2 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: 0934950
Sex: F
Age:
State: TX

Vax Date: 12/30/2020
Onset Date: 12/30/2020
Rec V Date: 01/11/2021
Hospital:

Lab Data: Test Name: covid; Result Unstructured Data: Test Result:no positive; Comments: She has had no positive test for covid prior to vaccine; Test Name: Weight; Result Unstructured Data: Test Result:Lost 20 lbs

Allergies:

Symptoms: She is having an allergic reaction; Itching was reported as worsened/Swelling was reported as worsened/loss of appetite was reported as worsened; From the time she got the vaccine to now, she has lost 20 lbs; shake/shaking; swelling in the lips, throat, and eye lids; swelling in the lips, throat, and eye lids; swelling in the lips, throat, and eye lids; She has been sick since Wednesday; itching all over from head to toe; loss of appetite; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at left arm on 30Dec2020 at single dose for COVID-19 immunization. Medical history included hypertension and allergic to ace inhibitors. There were no concomitant medications. Patient was calling about the Covid Vaccine. She was having an allergic reaction. She did not know what to do to stop it. She went to the ER yesterday (04Jan2021). She had been sick since Wednesday (30Dec2020), she was itching all over from head to toe since 30Dec2020, she got a prescription for Prednisone, she took 2 doses yesterday, 1 dose today, and would take another this evening. She took Benadryl, an hour ago and had an episode, and so she had to jump in the shower and let the cold water run to stop itching, the itching did not stop but it has minimized. She put Benadryl gel and she was still itching, she had taken enough Benadryl. Patient asked what is the best way and if she needed an IV of something, she went to ER on Sunday, she was not seen by doctor, it was a nurse practitioner, she didn't do anything but just listen to her and she only looked at ankles to check for swelling. Patient stated that she had been drinking water and urinating, she had no appetite and lost 20 lbs. Patient confirmed that she got her first dose of the Covid vaccine on 30Dec2020 at 1 o clock, the itching started the same day at 5 o clock, the itching was from head to toe. She experienced swelling in the lips, throat, and eye lids, which started 02Jan2021. She began losing her appetite on 30Dec2020. From the time she got the vaccine to now (05Jan2021), she has lost 20 lbs. An hour ago (05Jan2020) she had an episode, which made her shake, and she did not have the shakes before, this was the first date she started shaking. Itching was reported as worsened/Swelling was reported as worsened/loss of appetite was reported as worsened. Her 2nd dose was scheduled in 21 Days. However, she may not get the second dose, patient stated that she could not get through this no more. She had no positive test for Covid prior to vaccine. She had no antibody test prior to the vaccine. She had not any issues with vaccines in the past. Patient stated that if she was still feeling this way, she would go to a different hospital. When she went to the ER, she was not hospitalized, they sent her back home the same day. Patient would like to know if there was anything that can remove the vaccine from the body. The outcome of the events itching all over from head to toe, loss of appetite, swelling in the lips, throat, and eye lids was not recovered, of the other events was unknown. Information about lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 0934951
Sex: M
Age:
State: AZ

Vax Date: 12/17/2020
Onset Date:
Rec V Date: 01/11/2021
Hospital: Y

Lab Data: Test Name: HIV test; Result Unstructured Data: Test Result:Unknown results; Test Name: radiologic; Result Unstructured Data: Test Result:Acute demyelinating encephalomyelitis; Comments: states it looks like a radiologic diagnosis; Test Name: X-ray; Result Unstructured Data: Test Result:Unknown results

Allergies:

Symptoms: Acute demyelinating encephalomyelitis; Slurring his speech; Stroke; This is a spontaneous report from a contactable physician. A 35-year-old male patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular in deltoid (unknown if right or left) on 17Dec2020 at 30 ug, single for 'Preventative'. Medical history included hypertension. There were no concomitant medications.(Physician) He is calling about the Pfizer Covid 19 vaccine. States what is going on with the patient may be associated as a side effect. The patient got the vaccine two to three weeks ago, he clarifies the patient received the vaccine on 17Dec2020 and the patient ended up acutely developing (states it is a presumptive diagnosis) Acute demyelinating encephalomyelitis, states it looks like a radiologic diagnosis. The patient is an employee at hospital. When querying seriousness states it is medically significant but could be disabling but he thinks the patient will recover. Reporter seriousness for acute demyelinating encephalomyelitis: Medically significant, Hospitalization. Patient was hospitalized on Sunday and he is still admitted at this time. Dates when patient was in hospital for acute demyelinating encephalomyelitis was from 03Jan2021 to ongoing. Caller thinks the patient was flown to (Place) yesterday. The patient's mother asked the caller if the caller thought the acute demyelinating encephalomyelitis was from the vaccine and the caller responded that he did not think it was from the vaccine. He confirms the patient is still admitted in the hospital and the patient's attending neurologist is doctor. The caller heard about the patient from doctor. When querying covid vaccine dose, the caller states the standard dose is 30 mcg. This was clarified and documented as provided. The patient has not received his second dose yet. He asks if the patient should receive the second dose. He asks a general question if a pregnant patient can be given the Pfizer covid vaccine. He heard the patient had a stroke then the CFO tried to talk to him and the patient was slurring his speech. Caller spoke to the patient's mother this morning and caller told the mother that he would try to find out what is going on with the patient. He asked that the patient get an HIV test even though he does not think the patient is at risk. Vaccination facility type was Hospital. Vaccine administered at military facility was No. None additional vaccines administered on same date of the PFIZER suspect. AE acute demyelinating encephalomyelitis require a visit to Emergency Room, not visit to physician office. Prior Vaccinations (within 4 weeks) was none. He has heard of acute demyelinating encephalomyelitis being associated with vaccines in the past and states that it is rare and usually in kids. States he saw patients that may have had acute demyelinating encephalomyelitis back in the 80s and 90s. Therapeutic measures were taken as a result of acute demyelinating encephalomyelitis (Patient will get steroids tonight pending the review of the x-ray). The outcome of the events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: The reported stroke with speech slurred, and the presumptive diagnosis of acute demyelinating encephalomyelitis (looks like a radiologic diagnosis by the reporting physician), was most likely an intercurrent disease, and unlikely causally related to the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE). 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: 0934952
Sex: M
Age: 46
State: NJ

Vax Date: 01/06/2021
Onset Date: 01/07/2021
Rec V Date: 01/11/2021
Hospital:

Lab Data: None

Allergies: aspirin 325 mg, penicillin

Symptoms: Vaccine recipient experienced shivering, fever, severe headache, nausea, and generalized ache 12 hours after receiving the vaccine. On a follow-up call on 1/8/2021, he reported that the symptoms have resolved. Pfizer-BioNTech COVID- 19 Vaccine EUA.

Other Meds: Cymbalta

Current Illness: None

ID: 0934953
Sex: F
Age:
State:

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

Lab Data:

Allergies:

Symptoms: her nerve was bad; Getting all sick, cold, sick and experiencing terrible side effects; Getting all sick, cold, sick and experiencing terrible side effects; Fatigue; Muscle ache; Nauseous; Felt awful; Can't eat all the day, no appetite; phobic something to drinking water; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient received bnt162b2 (lot/batch number and expiration date not provided), via an unspecified route of administration, on an unspecified date, at single dose, for COVID-19 immunization. No relevant medical history. The patient's concomitant medications were not reported. The patient experienced getting all sick, cold, sick and experiencing terrible side effects, fatigue, muscle ache, nauseous, cannot do anything, felt awful, cannot eat all the day, no appetite, phobic something to drinking water. The patient has been sick for three days now. The patient was a "senior" (not clarified) care giver at the nursing home. Everybody at nursing home at the nursing home got the shot and now everybody has cold and sick. She has only one day of work and she has to come into her job to take care of elderly people. As since current everybody is experiencing the terrible adverse, terrible side effects, everything. Fatigue, muscle ache everything. The bosses at her nursing home cannot give them three days or even seven days off of work after receiving a contract to give them shot. It was confirmed that the patient received the COVID vaccine. The patient also stated that they are off of that side effects. They are not interrupted not just the "arm" (not clarified) been there. The patient said she getting everything. She was getting all the side effects. So when they had this Pfizer drug shot "they didn't get seven days off of" (not clarified) work. If a person gets a shot, they are feeling fatigue, nauseous (incomprehensible voice). They can't do anything. They should be allowed to stay home from work. Right now everybody in the nursing home is feeling the adverse effect. The entire building. So, she was telling Pfizer to report the report is that all of sudden that the nursing home "seniors" (not clarified) and nurses they got the shot, they can't even get to work. The effects are so bad that they can't do anything. The patient also stated that fatigue, she had fatigue all day. The first day she got the shot her nerve was bad but the second day was everything fatigue. She felt awful, she could not eat, she had no appetite. She was phobic something to drinking water, she cannot eat all the day. "Fruit or something 5 I can eat" (incomprehensible voice)." When probed for the LOT#, the reporter stated, "No they did not give me anything. All they did is I think 037 I think it looks like a 'K' 20A. (further not clarified) like it says (further not clarified) 037K20A that's (further not clarified)." The outcome of the events was unknown. Information on lot number/batch number was requested.

Other Meds:

Current Illness:

ID: 0934954
Sex: U
Age:
State:

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

Lab Data:

Allergies:

Symptoms: aware of 6 cases of Bell's Palsy by the companies making these vaccines; This is a spontaneous report from contactable Other HCP. This Other HCP reported same events for 6 patients. This report is for 2nd of 6 patients. 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 single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The other HCP was aware of 6 cases of Bell's Palsy by the companies making these vaccines since an unknown date. The event was reported as non-serious. The event outcome was unknown. Information about lot/batch number has been requested.; Sender's Comments: Based on a compatible temporal relationship, causality between event Bell's Palsy and BNT162B2 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.,Linked Report(s) : US-PFIZER INC-2021007605 same reporter, same drug, same event, different patients.

Other Meds:

Current Illness:

ID: 0934955
Sex: U
Age:
State:

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

Lab Data:

Allergies:

Symptoms: aware of 6 cases of Bell's Palsy by the companies making these vaccines; This is a spontaneous report from a contactable other HCP. This Other HCP reported similar events for 6 patients. This report is for 3rd of 6 patient. 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 SINGLE DOSE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The reporter reported since the use of modified RNA in covid vaccines, he/she had aware of 6 cases of Bell's Palsy by the companies making these vaccines since an unknown date. The outcome of the event was unknown. Information about batch/lot number has been requested.; Sender's Comments: Based on a compatible temporal relationship, causality between event Bell's Palsy and BNT162B2 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.,Linked Report(s) : US-PFIZER INC-2021007605 Different patient, same drug/event.

Other Meds:

Current Illness:

ID: 0934956
Sex: M
Age: 32
State: FL

Vax Date: 12/29/2020
Onset Date: 01/06/2021
Rec V Date: 01/11/2021
Hospital:

Lab Data: None

Allergies: NKDA

Symptoms: Vesicular single dermatome rash consistent with shingles. Previous case of varicella as child with documented titer markers. No eye, face, ear involvement. Rash is located around the T6 distribution on the left.

Other Meds: No RX at time of vaccine

Current Illness: None

ID: 0934957
Sex: U
Age:
State:

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

Lab Data:

Allergies:

Symptoms: aware of 6 cases of Bell's Palsy by the companies making these vaccines; This is Spontaneous report from a contactable Other HCP. This Other HCP reported similar events for 6 patients. This is 4th of six reports. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiration date not provided), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The reporter reported since the use of modified RNA in covid vaccines, he/she had aware of 6 cases of Bell's Palsy by the companies making these vaccines since an unknown date. The outcome of the event was unknown. Information on the Lot/batch number has been requested.; Sender's Comments: Based on a compatible temporal relationship, causality between event Bell's Palsy and BNT162B2 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.,Linked Report(s) : US-PFIZER INC-2021007605 same reporter, same drug, same event, different patient

Other Meds:

Current Illness:

ID: 0934958
Sex: U
Age:
State:

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

Lab Data:

Allergies:

Symptoms: aware of 6 cases of Bell's Palsy by the companies making these vaccines; This is a spontaneous report from a contactable other health professional (HCP). This other HCP reported similar events for 6 patients. This is the 5th of 6 patient. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiration date not provided), 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 reporter reported since the use of modified RNA in covid vaccines, he/she had aware of 6 cases of Bell's Palsy by the companies making these vaccines since an unknown date. The outcome of the event was unknown. Information about batch/lot number has been requested.; Sender's Comments: Based on temporal association, the causal relationship between bnt162b2 and the event facial paralysis cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once 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.,Linked Report(s) : US-PFIZER INC-2021007605 Different patient, same drug/event.

Other Meds:

Current Illness:

ID: 0934959
Sex: F
Age:
State: CT

Vax Date: 12/30/2020
Onset Date:
Rec V Date: 01/11/2021
Hospital:

Lab Data: Test Name: PCR swabbing; Result Unstructured Data: Test Result:Unknown results

Allergies:

Symptoms: Looked like an encephalopathy; Face was all swollen; Head swelled; Glands swelled; Fatigue; Headache/ So much pain in my head; Couldn't talk; Complete brain fog; nausea; This is a spontaneous report from a contactable nurse. This 60-year-old female nurse (Patient) reported that received bnt162b2 (BNT162B2, Pfizer COVID-19 vaccine), via an unspecified route of administration on 30Dec2020 at single dose for covid-19 immunisation. Medical history included Atrial fibrillation, Chronic Lyme, Lupus and Autoimmune. Concomitant medications included Metoprolol at 12.5 mg for Atrial fibrillation and acetylsalicylic acid (BABY ASPIRIN). No diabetes, no hypertension. None of the usual common diseases. Registered Nurse stated, "I received vaccine this past Wednesday. I was just talking to a couple of my colleagues and honestly I received the vac. at work. I did not really read through the paperwork and was 'weird' sharing reactions to the vaccine which for me was pretty bad reaction and thought like I need to go through your paperwork and report it. So I thought I should call and just give some information. The usual fatigue which I go to after being normal, my arm was not sore. However, as the week progressed into Friday I had a constant headache but it was manageable and then by Friday night my glands swelled, my nerves behind my ears, my neck and I was extremely fatigued, bad headache and went to bed and I had not gone out and finally I got out today I spoke with my Physician yesterday. What happened it looked like an encephalopathy but my head swelled, my face was all swollen, complete brain fog, fatigue and I couldn't talk. I was in so much pain in my head resulting in (incomplete sentence)." Lab work included the only thing is the PCR swabbing. No blood test. Registered Nurse further stated, "I don't know if that is important. But I will tell you and if it is you can send me the questions. I do have a history of Autoimmune. So my Physician thought that this was just like an enhancement of like my bodies reaction I have Chronic Lyme and I have lupus like my ANA has always been stressful. But we think that it is a family thing. No treatment for the Lyme. I did a lot of antibiotic and a lot of naturopathic stuff but that is in the past. But anyhow for anything else what I did was when I got the injection they said try and just take Tylenol not Ibuprofen but there was no way I was going to make it through with just that . So I took Ibuprofen. I called my Physician yesterday morning because I was not sure about what was is happening and I thought it might be secondary sinus infection or something else going on and it reassured me that it is definitely due to the vaccine. He said it is just your body's reaction, take the Ibuprofen, hydrate. Had me take what I had in my house Tigan for nausea. So I was extremely nauseous from the severity of the headache." Registered Nurse stated, "I just wanted to let you know what happened and the intensity of what it was because normally I would expect a headache. But this was a 'go dated'. Registered Nurse stated, "I guess the only question that I have is so do my work has this question and I was going to call my doctor tomorrow may be might know it better. I know that I have to take the second dose. But I understand the second round can be worse than the first. Is there anything that they are recommending that I can do may be prior to ease the reaction?" The outcome of the events was unknown. Information on the Lot/Batch number has been requested.; Sender's Comments: The reported clinical manifestations including swelling face and head swelled, which was suspected as encephalopathy by the reporting nurse, was probably related to the bnt162b2 (BNT162B2, Pfizer COVID-19 vaccine), due to temporal relationship. The subject's underlying Chronic Lyme, Lupus and Autoimmune were likely the risk factors to the onset of the events. 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: ; BABY ASPIRIN

Current Illness:

ID: 0934961
Sex: F
Age:
State: TX

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

Lab Data: Test Date: 20210105; Test Name: lactate; Result Unstructured Data: Test Result:1.5; Test Date: 20210105; Test Name: blood pressure; Result Unstructured Data: Test Result:90/50; Test Date: 202101; Test Name: blood pressure; Result Unstructured Data: Test Result:Normal range; Test Date: 20210104; Test Name: Temperature; Result Unstructured Data: Test Result:104; Test Date: 20210105; Test Name: Temperature; Result Unstructured Data: Test Result:102.8; Test Date: 202101; Test Name: Temperature; Result Unstructured Data: Test Result:105; Comments: axillary temperature; Test Date: 20210105; Test Name: CRP; Result Unstructured Data: Test Result:30; Test Date: 20210105; Test Name: heart rate; Result Unstructured Data: Test Result:144-152 at rest; Test Date: 202101; Test Name: heart rate; Result Unstructured Data: Test Result:109; Comments: normal range; Test Date: 20210105; Test Name: O2 sat; Result Unstructured Data: Test Result:95-96; Test Date: 20210105; Test Name: COVID-19 test; Test Result: Negative

Allergies:

Symptoms: Swollen lymph nodes; blood pressure was 90/50; Chills; body aches; Fatigue; Joint pain; Bone pain; Headache; Swelling, pain, redness and soreness at the injection site; Swelling, pain, redness and soreness at the injection site; Swelling, pain, redness and soreness at the injection site; Tachycardia / heart rate was 144-152; painful to breath and she was grunting; also said that the injection site itched a little bit.; Fever; First dose on 17Dec2020, second does on 04Jan2021; This is a spontaneous report from a contactable nurse reporting for herself. A 35-year-old female patient received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) ( (lot number was unknown) intramuscularly on 17Dec2020 at 0.3ml, and the second single dose (lot number EJ1685) intramuscularly on 04Jan2021 07:45 at 0.3ml, for COVID-19 prophylaxis. Medical history included ongoing diabetes. Her diabetes was diagnosed about 6 months ago (reported on 06Jan2021) and was well controlled. Her glucose was at 140 at the ER (emergency room) even after drinking a drink that had sugar in it. The patient's concomitant medications were not reported. The patient received the second dose on 04Jan2021 at 07:45 and experienced a severe reaction hours after she received it, and she ended up having to go the ER and that they were baffled about what happened. She reported her symptoms were: fatigue, joint pain mainly in her knees, bone pain that did not feel like muscle pain, headache, swollen lymph nodes in the left axilla, and swelling, redness, pain, and soreness in the left arm at the injection site and also said that the injection site itched a little bit. Her symptoms started about 9-10 at night on 04Jan2021. She said that she felt like with the second dose she noticed the soreness and pain and redness at injection site after about 2 hours after receiving the second dose, which was sooner than with the first injection. The fever started with the chills and body aches. The chills and body aches started at 22:00 on 04Jan2021. She took acetaminophen and melatonin to try and sleep it off. Fever was after that at around midnight 04Jan2021 and she was burning in fever and her temperature was 104. She stated she started taking layers off and got out from under her covers. She had a sweater on when she took her temperature and her axillary temperature was 105. She said that she got into a hot shower because that was the only thing that provided comfort to her chills. She had not had any chills in about the last 12 hours though (as reported on 06Jan2021). She said that the body aches were so severe that she just sat in her bed and cried. She had tachycardia and she was grunting in pain. She was rotating ibuprofen and acetaminophen and then her fever was not as high. She stated that if her fever came back it was lower each time, and if she did not take the medications though, the bone pain was excruciating. She said that with the bone pain it was like no-one can hold her hand or hug her. Fatigue started at around midnight 04Jan2021. Her headache was at midnight. She felt like she had a headband on and was radiating down the back of her neck. She noticed the lymph nodes were swollen after she went to the ER at around 07:00-08:00 05Jan2021. She was walking with pillow under her arm, and if she moved or lifted her arm it hurt. She went to the ER at 01:00 05Jan2021. Her blood pressure was 90/50, her heart rate was 144-152 at rest, temperature was 102.8, O2 saturation was 95-96. She said that it was painful to breath and she was grunting, but did not have any breathing issues. The nurse thought she was septic and notified the doctor. The nurse and the doctor did not think it was the vaccine and thought that she was COVID-19 positive. But after they tested her, she was negative for flu and COVID and they were baffled. They were unclear on what happened and did not think it was from the vaccine. They bolused her 1 liter of Normal Saline and gave her a dose of Fentanyl that minimally helped with the bone pain. She was also given 30mg of ketorolac (TORADOL) IV (intravenous) and that significantly improved her pain. She was there a total of 3 hours. She was admitted to the back area of the ER. She said that they drew labs and everything was within normal limits. Her CRP (C-reactive protein) was 30 and her lactate was at 1.5. She said that they told her that she was most likely having an immune response to the vaccine. Her heart rate and blood pressure came to a more normal range and everything returned to baseline. Her heart rate was 109. She was told to rotate paracetamol (TYLENOL) and ibuprofen for at least the next 24 hours and hydrate. The events fever, chills, fatigue, joint pain, bone pain, headache, swollen lymph nodes, and swelling, pain, redness and soreness at the injection site were serious due to hospitalization from 05Jan2021 to 05Jan2021. The patient was recovering from fever, chills, joint pain, headache, heart rate and blood pressure, not recovered from fatigue, bone pain, swollen lymph nodes and swelling, pain, redness and soreness at the injection site. The event swollen lymph nodes worsened. The outcome of "injection site itched a little bit" was unknown. The reporter considered the events fever, chills, fatigue, joint pain, bone pain, headache, swollen lymph nodes, and swelling, pain, redness and soreness at the injection site were all related to the vaccine; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events pyrexia, chills, fatigue, pain, arthralgia, bone pain, headache, lymphadenopathy, vaccination site erythema, vaccination site swelling, vaccination site pain, blood pressure decreased, tachycardia, grunting and vaccination site pruritus cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once 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:

Current Illness: Diabetes (Verbatim: Diabetes)

ID: 0934962
Sex: F
Age: 58
State: OH

Vax Date: 01/08/2021
Onset Date: 01/11/2021
Rec V Date: 01/11/2021
Hospital:

Lab Data: NA

Allergies: sulfa (sulfonamide antibiotics)- vomiting

Symptoms: 01-08-21 - headache; injection site sore 01-09-21 - headache; injection site sore 01-10-21 - headache; injection site sore 01-11-21 - headache; injection site sore, injection site redness; injection site warm to touch

Other Meds: KEFLEX; NEXIUM; NOVOLOG; LANTUS; PRILOSEC

Current Illness:

ID: 0934964
Sex: F
Age: 37
State: TX

Vax Date: 12/29/2020
Onset Date: 01/04/2021
Rec V Date: 01/11/2021
Hospital:

Lab Data:

Allergies: n/a

Symptoms: 6 days post injection, arm became red, warm, hard

Other Meds: multivitamin vitamin d3

Current Illness: n/a

ID: 0934965
Sex: F
Age:
State: WV

Vax Date: 12/01/2020
Onset Date: 12/01/2020
Rec V Date: 01/11/2021
Hospital:

Lab Data:

Allergies:

Symptoms: The lip starting ripping and the face started itching; The lip starting ripping and the face started itching; It started spreading from the ear to the neck, it started itching bad and getting hive in that area; having trouble in breathing because it was swelling up; having trouble in breathing because it was swelling up; The lip was swelled to red and then it started to going up the jaw; The lip was swelled to red and then it started to going up the jaw; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot#: EJ1686, expiration date: Mar2021) via an unspecified route of administration on the arm right in Dec2020 at single dose for COVID-19 immunisation. Medical history included ongoing blood pressure high. Concomitant medication included lisinopril taken for blood pressure high. The patient had the BNT162B2 on Thursday morning (Dec2020) and Thursday evening the patient had a reaction to that, the lip was swelled to red and then it started to going up the jaw. So the next day it was in the jaw and in the lip and then the lip starting ripping and the face started itching and that's didn't go away and then yesterday it started spreading from the ear to the neck, it started itching bad and getting hive in that area. The patient went to the emergency room, consumer stated that she had nurse practitioner that called her on a steroid (treatment). The consumer stated, "the thing she called her also in an Epi Pen in case she has started having trouble in breathing because it was swelling up. The patient didn't have to end up using that but she just has to use in case she has". Treatment was received for the events. The outcome of the events was unknown.

Other Meds:

Current Illness: Blood pressure high

Date Died: 01/04/2021

ID: 0934966
Sex: F
Age:
State: CA

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

Lab Data: Test Date: 20201225; Test Name: COVID-19; Test Result: Negative ; Test Date: 20210104; Test Name: COVID-19; Test Result: Positive

Allergies:

Symptoms: COVID-19; COVID-19; Pneumonia; respiratory failure; This is a spontaneous report from a contactable consumer. An 80-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 02Jan2021 for COVID-19 immunization. Medical history included Alzheimer's and others. No known allergies. Concomitant medications included unspecified medications. The reporter's mother in law was tested for COVID-19 at a nursing facility on 25Dec2020 and she was negative. On 02Jan2021, she received the first dose of Pfizer vaccine. On 04Jan2020, she developed a high fever, needed oxygen and was positive for COVID-19. Date of death was 04Jan2021. The cause of her death was listed as pneumonia, respiratory failure and COVID-19. No autopsy performed. No treatment received. No one knew if the vaccination contributed to her death. It was hard to know if her death was due to the administration of the vaccine or it exacerbated the COVID19 symptoms which led to her death. Since this was unknown, it could have been a possibility. The reporter wanted to give us this information because we might want to consider having high risk population, patients with underlying conditions, older population tested for COVID-19 prior to the vaccination, as this is not currently a recommendation or a requirement. All is very new and they are all learning so the reporter wanted to share this information with us. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There are medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. The outcome of the events was fatal. Information about Lot/Batch has been requested.; Sender's Comments: The association between the fatal event lack of effect (pneumonia, respiratory failure and COVID-19) with BNT162b2 can not be fully 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.; Reported Cause(s) of Death: Pneumonia, respiratory failure and COVID-19; Pneumonia, respiratory failure and COVID-19; Pneumonia, respiratory failure and COVID-19; Pneumonia, respiratory failure and COVID-19

Other Meds:

Current Illness:

ID: 0934967
Sex: M
Age: 61
State: OH

Vax Date: 01/05/2021
Onset Date: 01/07/2021
Rec V Date: 01/11/2021
Hospital:

Lab Data: Prescribed a course of augmentin in case of infection. Will get a facial xray to rule out dental issue if swelling and pain persist after antibiotics.

Allergies:

Symptoms: Facial swelling along the left side of the face along jawline leading up to ear. Pain when closing mouth resulting in some drooling from keeping mouth open. Also some nasal drainage and feeling of unwell. Telehealth appointment occurred on 1/8/21. Both corners of his mouth would raise when smiling so a stroke was ruled out. Could possibly be a coincidence with the vaccine timing but healthcare professional advised us to report it here.

Other Meds: Humira, levothyroxine, aspirin, multi vitamin, ensure, metamucil, Dexilant,Ferrous sulfate, folic acid, vitamin B12, Vitamin C, Methotrexate

Current Illness:

Date Died: 01/06/2021

ID: 0934968
Sex: M
Age:
State: CA

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

Lab Data:

Allergies:

Symptoms: he passed away; not responsive; mind just seemed like it was racing; body was hyper dried; Restless; not feeling well; ate a bit but not much; kind of pale; Agitated; Vomiting; trouble in breathing; This is a spontaneous report from a contactable consumer (brother of the patient). A 54-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on 04Jan2021 (at the age of 54-years-old) as a single dose for COVID-19 immunization. Medical history included diabetes and high blood pressure. Concomitant medications included metformin (MANUFACTURER UNKNOWN) taken for diabetes, glimepiride (MANUFACTURER UNKNOWN) taken for diabetes, lisinopril (MANUFACTURER UNKNOWN), and amlodipine (MANUFACTURER UNKNOWN). The patient experienced not feeling well, ate a bit but not much, kind of pale, vomiting, trouble in breathing, and agitated on 04Jan2021; body was hyper dried and restless on 05Jan2021; mind just seemed like it was racing on 06Jan2021; and not responsive and he passed away on 06Jan2021 at 10:15 (reported as: around 10:15 AM). The clinical course was reported as follows: The patient received the vaccine on 04Jan2021, after which he started not feeling well. He went right home and went to bed. He woke up and ate a bit but not much and then was kind of pale. The patient then started to vomit, which continued throughout the night. He was having trouble in breathing. Emergency services were called, and they took his vitals and said that everything was okay, but he was very agitated; reported as not like this prior to the vaccine. The patient was taken to urgent care where they gave him an unspecified steroid shot and unspecified medication for vomiting. The patient was told he was probably having a reaction to the vaccine, but he was just dried up. The patient continued to vomit throughout the day and then he was very agitated again and would fall asleep for may be 15-20 minutes. When the patient woke up, he was very restless (reported as: his body was just amped up and could not calm down). The patient calmed down just a little bit in the evening. When the patient was awoken at 6:00 AM in the morning, he was still agitated. The patient stated that he couldn't breathe, and his mind was racing. The patient's other brother went to him and he was not responsive, and he passed away on 06Jan2021 around 10:15 AM. It was reported that none of the symptoms occurred until the patient received the vaccine. Therapeutic measures were taken as a result of vomiting as aforementioned. The clinical outcome of all of the events was unknown; not responsive was not recovered, the patient died on 06Jan2021. The cause of death was unknown (reported as: not known by reporter). An autopsy was not performed. The batch/lot number for the vaccine, BNT162B2, was not provided and has been requested during follow up.; Reported Cause(s) of Death: not responsive and he passed away

Other Meds: ; ; ;

Current Illness:

ID: 0934969
Sex: F
Age:
State:

Vax Date: 12/23/2020
Onset Date: 12/26/2020
Rec V Date: 01/11/2021
Hospital:

Lab Data: Test Date: 20201226; Test Name: Fever; Result Unstructured Data: Test Result:Fever

Allergies:

Symptoms: Acute appendicitis; Severe acute abdominal pain; Chills; Fever; This is a spontaneous report from a contactable Nurse (patient). A 42-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (expiration date Mar2021, incomplete lot number L0140, not sure the first letter it is C or E), via an unspecified route of administration on 23Dec2020 at single dose for covid-19 immunization. None medical history. Concomitant medication included escitalopram oxalate (LEXAPRO). The patient experienced a little bit chills and fever she felt coming exactly on the 26th but she expected that and that was all fine but patient ended up in (Incomplete sentence). She went to work on 30th December and had some onset of severe acute abdominal pain and she ended up in an emergency appendectomy by 6 O'clock that evening. So she had an acute appendicitis and she did some research and it says that she can be listed in to the severe complications that the number in the vaccinated group was double back to the procedural group. The 26th it resided and patient felt better until the 30th when she have acute severe abdominal pain onset. She left work went for emergency room and she was in surgery within four hours. The outcome of events chills and fever was recovering, the other events was unknown. Because of the research that is on the website patient cannot help and think that it is related. Patient believed the relatedness of drug to events was related. Information about lot/batch number has been requested.; 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: LEXAPRO

Current Illness:

ID: 0934970
Sex: F
Age: 60
State:

Vax Date: 01/08/2021
Onset Date: 01/08/2021
Rec V Date: 01/11/2021
Hospital:

Lab Data:

Allergies:

Symptoms: dizziness around 8:00pm, fatigue, severe headache, neck & shoulder pain, body aches, joint pain, nauseous, mild shortness of breath

Other Meds:

Current Illness:

ID: 0934971
Sex: M
Age: 2
State: MI

Vax Date: 12/29/2020
Onset Date: 12/29/2020
Rec V Date: 01/11/2021
Hospital:

Lab Data:

Allergies:

Symptoms: FLUBLOK to patients under 18 years of age (with no adverse event); Initial information was received on 04-Jan-2021 regarding an unsolicited valid non-serious case from an other health professional. This case involves a 2 year old male patient who received 0.5 mL dose of influenza quadrivalent recombinant vaccine (Flublok QIV) (lot number: UJ509AA, expiry date: 10-MAY-2021) via intramuscular route in the left deltoid as prophylactic vaccination on 29-Dec-2020. Medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was not reported. It was a case of an actual medication error due to inappropriate age at vaccine administration. At the time of report no adverse event was reported. It was reported that, administration of FLUBLOK to patients under 18 years of age. Caller reports FLUBLOK had been administered to 11 pediatric patients. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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: 0934972
Sex: F
Age: 17
State: MI

Vax Date: 12/22/2020
Onset Date: 12/22/2020
Rec V Date: 01/11/2021
Hospital:

Lab Data:

Allergies:

Symptoms: administration of FLUBLOK to 17 years of patient with no adverse event; Initial information was received on 04-Jan-2021 regarding an unsolicited valid non-serious case received from an other health professional. This case involves a 17 year old female patient who was administered with QUADRIVALENT RECOMBINANT INFLUENZA VACCINE (FLUBLOK QIV) (Product administered to patient of inappropriate age). Reporter would like to know if they were "covered" for influenza vaccination for the season. Medical history was not provided. Concomitant medications was not reported. On 22-Dec-2020, the patient received a 0.5 ml once dose of suspect QUADRIVALENT RECOMBINANT INFLUENZA VACCINE (Prefilled syringe) via intramuscular route in the left deltoid (lot UJ509AA and expiry date 10-May-2021) for prophylactic vaccination. It was a case of actual medication error due to Inappropriate age at vaccine administration. (latency- same day) At the time of report, no adverse event was reported. (None- adverse event symptoms were 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

Other Meds:

Current Illness:

ID: 0934973
Sex: F
Age: 92
State: TN

Vax Date: 01/05/2021
Onset Date: 01/06/2021
Rec V Date: 01/11/2021
Hospital:

Lab Data: NA

Allergies: Sulfa

Symptoms: Resident experienced vomiting and edema of the lips. The M.D prescribed benadryl.

Other Meds:

Current Illness: Alzheimers, Dementia, CVA (Hx), diabetes, CAD, SARS-CO-V2

ID: 0934974
Sex: U
Age:
State:

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

Lab Data:

Allergies:

Symptoms: Local reactions back to back; This spontaneous case was received on 17-Dec-2020 from other non-health professional (consumer) via Med Communications (reference number: SEQW20-05827) and concerned a patient of unreported age and gender. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine, subunit influenza virus vaccine polyvalent; dose, route of administration and anatomical location: not reported) for influenza prophylaxis. The batch number reported was 279847, expiration date: 30-Jun-2021. On an unspecified date, an unknown amount of time after receiving Flucelvax Quadrivalent, the patient developed local reactions back to back. It was not reported whether the patient received any corrective treatment. The outcome of the event was unknown. The reporter did not provide causality assessment. The case is linked to the cases 202007728, 202007729 and 202007730 (the same reporter). Company comment:The patient was vaccinated with the suspect product, Flucelvax Quadrivalent. On an unspecified date and unknown amount of time after receiving vaccine, the patient developed local reaction. Chronology is unclear. More information regarding temporal relationship, concomitant medications and underlying medical history is needed. Causality is assessed as unassessable due to lack of information.; Sender's Comments: The patient was vaccinated with the suspect product, Flucelvax Quadrivalent. On an unspecified date and unknown amount of time after receiving vaccine, the patient developed local reaction. Chronology is unclear. More information regarding temporal relationship, concomitant medications and underlying medical history is needed. Causality is assessed as unassessable due to lack of information.

Other Meds:

Current Illness:

ID: 0934975
Sex: F
Age: 54
State: CA

Vax Date: 12/27/2020
Onset Date: 01/07/2021
Rec V Date: 01/11/2021
Hospital:

Lab Data: Labs (troponin, CBC, CMP and some others I am unaware of) were done at both ED visits as was an EKG and chest Xray. I was told the only issue was found on my EKG which showed atrial flutter. ED visit #1 was on 1/7/21 and ED visit #2 was on 1/8/21. I was cardioverted on 1/8/21 and sent home on Eliquis. I have follow up with a cardiologist on 1/13/21 and with my PCP today at 1400.

Allergies: NKDA

Symptoms: On day 11 post vaccine administration, I started to experience an irregular heart rhythm. I went to the ED at my place of employment and was found to be in atrial flutter. Just prior to them administering a medication (metropolol), I spontaneously converted back to sinus rhythm. I was sent home and told to follow up with my PCP or go to the ED should it return. The following evening around 515 pm, I went into the same type of rhythm so went to the ED for evaluation. I was again found to be in atrial flutter after a repeat EKG was done. About two hours after arriving, I was cardioverted and my rhythm returned to sinus rhythm. I was discharged home and continue to be in sinus rhythm and am now on blood thinners.

Other Meds: Zyrtec, Flonase, Vit D

Current Illness: N/A

ID: 0934976
Sex: U
Age:
State:

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

Lab Data:

Allergies:

Symptoms: Local reactions back to back; This spontaneous case was received on 17-Dec-2020 from other non-health professional (consumer) via Med Communications (reference number: SEQW20-05827) and concerned a patient of unreported age and gender. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine, subunit influenza virus vaccine polyvalent; dose, route of administration and anatomical location: not reported) for influenza prophylaxis. The batch number reported was 279847, expiration date: 30-Jun-2021. On an unspecified date, an unknown amount of time after receiving Flucelvax Quadrivalent, the patient developed local reactions back to back. It was not reported whether the patient received any corrective treatment. The outcome of the event was unknown. The reporter did not provide causality assessment. The case is linked to the cases 202007727, 202007729 and 202007730 (the same reporter). Company comment:The patient was vaccinated with the suspect product, Flucelvax Quadrivalent. On an unspecified date and unknown amount of time after receiving vaccine, the patient developed local reaction. Chronology is unclear. More information regarding temporal relationship, concomitant medications and underlying medical history is needed. Causality is assessed as unassessable due to lack of information.; Sender's Comments: The patient was vaccinated with the suspect product, Flucelvax Quadrivalent. On an unspecified date and unknown amount of time after receiving vaccine, the patient developed local reaction. Chronology is unclear. More information regarding temporal relationship, concomitant medications and underlying medical history is needed. Causality is assessed as unassessable due to lack of information.

Other Meds:

Current Illness:

ID: 0934977
Sex: U
Age:
State:

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

Lab Data:

Allergies:

Symptoms: Local reactions back to back; This spontaneous case was received on 17-Dec-2020 from other non-health professional (consumer) via Med Communications (reference number: SEQW20-05827) and concerned a patient of unreported age and gender. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine, subunit influenza virus vaccine polyvalent; dose, route of administration and anatomical location: not reported) for influenza prophylaxis. The batch number reported was 279847, expiration date: 30-Jun-2021. On an unspecified date, an unknown amount of time after receiving Flucelvax Quadrivalent, the patient developed local reactions back to back. It was not reported whether the patient received any corrective treatment. The outcome of the event was unknown. The reporter did not provide causality assessment. The case is linked to the cases 202007727, 202007728 and 202007729 (the same reporter). Company comment:The patient was vaccinated with the suspect product, Flucelvax Quadrivalent. On an unspecified date and unknown amount of time after receiving vaccine, the patient developed local reaction. Chronology is unclear. More information regarding temporal relationship, concomitant medications and underlying medical history is needed. Causality is assessed as unassessable due to lack of information.; Sender's Comments: The patient was vaccinated with the suspect product, Flucelvax Quadrivalent. On an unspecified date and unknown amount of time after receiving vaccine, the patient developed local reaction. Chronology is unclear. More information regarding temporal relationship, concomitant medications and underlying medical history is needed. Causality is assessed as unassessable due to lack of information.

Other Meds:

Current Illness:

ID: 0934979
Sex: F
Age: 57
State: IN

Vax Date: 01/09/2021
Onset Date: 01/10/2021
Rec V Date: 01/11/2021
Hospital:

Lab Data: n/a

Allergies: Ciprofloxacin, Penicillin, Atorvastin.

Symptoms: Chills, fever, body aches, light headed, weakness.

Other Meds: Vitamin D3, Synthroid, ASA 81 mg, Vitamin C, Multivitamin, Praluent injection

Current Illness: N/A

ID: 0934980
Sex: F
Age: 65
State: NJ

Vax Date: 01/09/2021
Onset Date: 01/09/2021
Rec V Date: 01/11/2021
Hospital:

Lab Data: none

Allergies: Augmentin

Symptoms: Moderna COVID-19 Vaccine EUA...Pain in the left arm with tenderness and warm to touch. In addition joint pain in my left ankle, swelling. Unable to put pressure when standing or walking. Using a cane since I did have an injury in the ankle 10 years ago. Also had a left hip replacement in 2016.

Other Meds: Atorvastatin 40mg Triamt/Hctz 37.5-25mg Metoprol tab 50mg 2x day Xarelto 20mg Vitamin D

Current Illness: none

ID: 0934981
Sex: F
Age: 41
State: MT

Vax Date: 01/07/2021
Onset Date: 01/11/2021
Rec V Date: 01/11/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Arm Soreness, redness around injection site

Other Meds:

Current Illness:

ID: 0934982
Sex: F
Age: 39
State: MI

Vax Date: 01/05/2021
Onset Date: 01/06/2021
Rec V Date: 01/11/2021
Hospital:

Lab Data: Ultrasound of left upper arm 1/7/2021

Allergies: None

Symptoms: Developed extensive bruising, swelling, pain, to left deltoid, upper arm and numbness and tingling in her left wrist extending to her left thumb and index finger Patient is a 39 y.o. female with a past medical history of asthma and obesity who presents for evaluation of Chief Complaint Patient presents with Arm pain Reaction to covid injection Patient has swelling and bruising at the site of her recent COVID-19 injection given 2 days prior. She has been icing the area taking Motrin without relief. She has pain with movement of the arm and it seem to be worsening. She notes some numbness and tingling in her left wrist extending to her left thumb and index finger. She has a prior history of carpal tunnel. Blood pressure is well controlled today. No fever, chest pain, palpitation, shortness of breath. Exercise tolerance is stable. Tolerating medications well.

Other Meds: None noted

Current Illness: None noted

ID: 0934983
Sex: M
Age: 51
State: CA

Vax Date: 01/07/2021
Onset Date: 01/08/2021
Rec V Date: 01/11/2021
Hospital:

Lab Data:

Allergies: None

Symptoms: Soreness in left arm at sight of injection within 12 hours, joint pain in left shoulder within 12 hours, slight headache within 14 to 16 hours and fatigue / general weakness within 24 hours lasting approximately 12 hours. All side affects gone within 48 hours of initial injection.

Other Meds: None

Current Illness: None

ID: 0934984
Sex: M
Age: 76
State: TX

Vax Date: 01/05/2021
Onset Date: 01/06/2021
Rec V Date: 01/11/2021
Hospital:

Lab Data:

Allergies: None

Symptoms: Pt complains of severe lethargy since injection (6 days). Severe enough that he is unable to leave the house as is his usual custom. Denies fever. Reports blood sugars lower than normal and he's had to adjust his insulin intake in response to this. Some nausea, but no vomiting. Denies fever.

Other Meds: Lantus Victoza Glucophage Allopurinol ASA Lipitor

Current Illness: Diabetes

ID: 0934985
Sex: F
Age: 44
State: CA

Vax Date: 01/07/2021
Onset Date: 01/07/2021
Rec V Date: 01/11/2021
Hospital:

Lab Data:

Allergies: penicilin

Symptoms: Tongue and lips started to feel "prickily" and then became numb. The next two or so days pain in my right kidney area.

Other Meds: Zoloft, nyquil zzz, advil

Current Illness: recent history of iron deficient anemia (iron infusions a few months prior to vaccination)

ID: 0934986
Sex: M
Age: 61
State: WI

Vax Date: 12/17/2020
Onset Date: 12/18/2020
Rec V Date: 01/11/2021
Hospital:

Lab Data: none

Allergies:

Symptoms: Per the patient's description, about 36 hours after the first dose he began having pain and tingling sensation and feeling of swelling in both feet and less in both hands. He had difficulty walking for about 2 days. No fever or anything else. After the second dose given on January 5, 2021, Lot number EL1284, he had a milder reaction that lasted for one day and started 2 days after the shot.

Other Meds:

Current Illness:

ID: 0934987
Sex: F
Age: 42
State:

Vax Date: 01/09/2021
Onset Date: 01/09/2021
Rec V Date: 01/11/2021
Hospital:

Lab Data: Slightly tachycardic.

Allergies: Banana, latex, azithromycin

Symptoms: The patient observed to be flushed, lightheaded, and nauseous 10 min after the vaccine. Denies, trouble breathing, chest discomfort, or difficulty swallowing, facial swelling, or notable rash. Did not eat breakfast that morning and was nervous about receiving the vaccine. Slightly tachycardic. Given cetirizine 10 mg with relief.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 134,999

Page last modified: 14 December 2021 10:42pm