VAERS 2021 Database www.vaers.hhs.gov

Main Page | All 2021 Deaths | Videos
VAERS Updated: 11/12/2021
** VAERS DATABASE Last updated: November 12, 2021**
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Manufacturers

Total Manufacturer
199,106MODERNA
36,710JANSSEN
5,381PFIZER\BIONTECH
2,555GLAXOSMITHKLINE BIOLOGICALS
1,469UNKNOWN MANUFACTURER
897MERCK & CO. INC.
627SEQIRUS, INC.
112DYNAVAX TECHNOLOGIES CORPORATION
91SANOFI PASTEUR
75NOVARTIS VACCINES AND DIAGNOSTICS
40EMERGENT BIOSOLUTIONS
14PAXVAX
12TEVA PHARMACEUTICALS
12PROTEIN SCIENCES CORPORATION
9PFIZER\WYETH
4BERNA BIOTECH, LTD.
4SMITHKLINE BEECHAM
3INTERCELL AG
1MEDIMMUNE VACCINES, INC.
1CSL LIMITED

COVID19 Lot Number

VAX LOT Total
2S9CL7,949
7,473
2,547
1,506
1,187
1,051
1,049
s0294561,043
866
IMM209861
816
UT7065MA766
657
579
U62828AA563
557
538
U6737AA516
515
S034636506
4F472471
458
P100253275449
444
276563436
429
418
4BH32414
MENVEO404
PP9L5362
UJ446AA337
319
306
290
271
49TM3270
R1B252M253
4F472179
933622147
C5763AA144
CW3116134
3Y7NL126
UNK114
113
ARBA141A105
104
103
96
300057A90
79
1F4EB73
R1B743M62
56
UJ090AA55
51
UH894AB46
45
UNK44
UNK42
42
EJ168638
Unknown36
35
34
32
32
26
el128424
24
A115A22
22
EN620222
21
UNK20
20
19
Z127A19
19
17
JEV18K95E15
12
111798PI12
10
A739088
No batch number8
3333324181078
6
6
TAR356
5
5
U6935AA5
UNK5
4
unknown4
3
2
55RB72
2
2
2
2
2
U7124AA2
JEV18A68E2
2
ABYB05BA1
1
1
1
1
AMVA436A1
1
1
TJ3521
A130A; VIS give1
1
U7140BB1
1
1
SP UP016AA1
1
1808P08802/ESV01
037K20A300,947
EL1284288,578
57,766
1,432

Incidents per State

State Total
82,750
CA62,821
FL38,209
TX36,512
NY34,921
PA23,646
IN23,622
IL20,597
MI19,590
OH19,426
NJ18,413
NC16,769
GA15,932
WA15,351
VA15,234
MA14,876
AZ14,206
MN12,940
MD12,656
CO11,908
WI11,425
MO10,240
TN9,685
OR8,768
KY8,437
CT8,300
SC6,700
OK6,293
AL5,692
LA5,025
IA4,825
KS4,821
UT4,637
NV4,374
NM3,967
AR3,807
ME3,161
NH3,096
NE2,918
MS2,859
ID2,785
WV2,469
HI2,459
PR2,417
MT2,414
RI2,076
DE1,868
AK1,830
VT1,734
DC1,715
ND1,388
SD1,269
WY866
GU118
VI69
AS47
MP29
MH8
XB6
FM4
QM3
XV2
XL1

ID: 1711717
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/18/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 037K20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Dysphagia, Epiglottitis

Symptoms: gave a "whole vial, 6 doses to one patient."; This is a spontaneous report from a contactable Pharmacist. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown) on an unspecified date at single dose via an unspecified route of administration for COVID-19 immunization. Relevant medical history and concomitant medications were not reported. Reporter informed that the Clinic across the street gave a whole vial, 6 doses to one patient. HCP was unsure if the Vaccine was diluted or undiluted because They weren't answering their phone, so he can't find out right now. HCP was also unable to provide any patient information at this time. Reporter was at a hospital and he was got a safety issue at one his clinics across the street (as reported). They gave a whole vial to a patient, he clarified as six doses. He didn't know if they should send them to the ER or just monitor them at the clinic for an hour. He was concerning for any guidance on that. The patient experienced overdose on an unspecified date with outcome unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up. Sender's Comments: Based on plausible dose, event relationship post vaccination, and the causal role of BNT162B2 vaccine cannot be excluded for the reported even. The impact of this report on the benefit/risk profile of the product is evaluated as part of 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, as appropriate.

Other Meds:

Current Illness:

ID: 1711718
Sex: F
Age:
State: CA

Vax Date: 09/01/2021
Onset Date: 09/01/2021
Rec V Date: 09/18/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025L20A
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Anxiety, Dyspnoea

Symptoms: couldn't sleep at all; she was rushing, she had a lot of energy and she couldn't settle down; extremely fatigued; shaking; diarrhea; doesn't feel well / She doesn't feel well and she wants to know if she is okay; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 01Sep2021 (Batch/Lot number was not reported) as single dose for Covid-19 immunisation. The patient medical history was not reported. Historical vaccine included Flu vaccine in 1998 (23 years ago) for immunization which she had an adverse reaction. The patient's concomitant medications were not reported. The patient stated she got the first dose of the vaccine on Wednesday night (01Sep2021) and was having some issues and wanted to talk to someone because she was alone and doesn't feel well (Sep2021). She was fine with no pain or side effects all day yesterday. Thursday she was fine. Friday (03Sep2021), well last night, she couldn't sleep at all. It was like she was rushing, she had a lot of energy and she couldn't settle down. She didn't sleep an hour and now was extremely fatigued today. On an unknown date in Sep2021, she has been shaking, didn't sleep, had diarrhea and was fatigued but has no pain at the site of the injection. She can't tell if these are normal things. She just can't tell if it was from the vaccine or what was going on and thought someone should be told. She said she consulted the doctor about her symptoms and they referred her. She stated because she had an adverse reaction to a flu shot many years ago, where she had an immediate reaction with that, she just didn't feel right and wanted to make sure the symptoms she has were normal and she stated it does not say anything about how long they last in the paperwork she received. She also wanted to know how soon a bad reaction would occur after the vaccine, if it was within an hour. She didn't feel well and she wanted to know if she was okay. She stated she was fine and she was expecting a reaction early and didn't have anything and said that it was good to hear [regarding when severe allergic reactions usually occur vs side effects] and made her feel a little calmer. She stated she will keep sipping water and rest as much as she can. She stated if she did get worse she may not be able to call anybody. Outcome of the events was unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1711719
Sex: F
Age:
State: NJ

Vax Date: 08/23/2021
Onset Date: 08/01/2021
Rec V Date: 09/18/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot: EL1284
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data: Test Date: 20210829; Test Name: blood work; Result Unstructured Data: Test Result:unknown results; Test Date: 20210829; Test Name: ultrasound of heart; Result Unstructured Data: Test Result:unknown results; Test Date: 20210829; Test Name: EKG; Result Unstructured Data: Test Result:everything was fine; Comments: she also had 2 EKGs done, 1 in the urgent care and 1 in the hospital on Sunday; Test Date: 20210829; Test Name: EKG; Result Unstructured Data: Test Result:everything was fine; Comments: she also had 2 EKGs done, 1 in the urgent care and 1 in the hospital on Sunday; Test Date: 2021; Test Name: full physical exam; Result Unstructured Data: Test Result:that nothing was wrong; Comments: shows that nothing was wrong with her.; Test Date: 20210829; Test Name: full physical exam; Result Unstructured Data: Test Result:unknown results; Test Date: 20210829; Test Name: X-ray; Result Unstructured Data: Test Result:unknown results

Allergies:

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

Symptoms: was feeling something weird; it felt like she was going to have a heart attack, it was scary and like a grabbing in her chest where the heart is; hard time breathing; pain down her neck and around the ribs at the bottom of her breast and into the heart area and that's when it grabbed.; diagnosed with inflammation around her heart/ high carditis; This is a spontaneous report from a contactable consumer (patient). A 48-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot Number: FC3180, expiry date not reported), via an unspecified route of administration, administered in right arm on 23Aug2021 10:10 (at the age of 48 years old) as dose 1, single for covid-19 immunization. Medical history included high blood pressure, for which she was diagnosed about 4-5 years ago; and she had surgery on her left wrist. There were no concomitant medications. The patient had no prior vaccinations (within 4 weeks). Patient received the 1st dose of the Comirnaty vaccine on 23Aug2021. Patient got diagnosed with inflammation around her heart after (2021). She was in urgent care and emergency on 29Aug2021. She stated that doctor mentioned taking Z-pak before taking the next dose. As per caller, her doctor informed her that she could be given a Z-pak before the second shot. However, she still has to consult with a cardiologist regarding this. She also mentioned that she just wanted to report herself because she was told that what she was experiencing was rare. She added that 2 weeks prior to getting the 1st shot (2021), she had a full physical exam which showed that nothing was wrong with her. She was scared about getting the shot but mentioned that she still wanted to get it. She also asked until when will her symptom last. She wanted to know when she can receive the 2nd shot of the Comirnaty vaccine due to her symptoms and because she still needed to consult with a cardiologist on what to take or do before she receives the 2nd shot. The patient mentioned that the patient took Covid 19 vaccine as her mom and dad are elderly and she works with children. She further mentioned that she had the Pfizer shot about 2 and a half weeks ago and had a reaction to it 5 days into it that led her to the urgent care and then the hospital and then to her doctor. She wanted to report because of the fact that it was inflammation around her heart and was documented that way. This was her 1st dose. Patient right now not to get the 2nd dose to see how she feels a little longer because of her heart. She had an ultrasound of her heart, an x ray and bloodwork and had a full physical (all on 29Aug2021) before getting the shot and it was documented (unknown results). She was scared of getting it, it hurt like she couldn't breath; it was really difficult. She was told by her doctor the pharmacist that gave the shot to delay her shot but maybe be put on medication before the shot, the doctor said that like a Z-Pack. She works for the school district and they all have to get the shot and she suffered very bad, she drove herself to the urgent care and they called the hospital and said to go right now. She was told they may want to put her on something before the next shot and was wanting to know if we have information on this. She was a certified home health aide before the pandemic. She was diagnosed with high carditis, she could not recall how to say it and has it written down somewhere; it was where there was inflammation around the heart. She further mentioned that she got her 1st dose on 23Aug2021 and she went to the urgent care, she was feeling something weird and it got stronger and uncomfortable and it was scary, on Sunday 29Aug2021. The feeling weird started 25Aug2021 and in Aug2021 progressed to a hard time breathing, it felt like she was going to have a heart attack, it was scary and like a grabbing in her chest where the heart is. She got the vaccine in her right side not the left as she had surgery on her left wrist and she did not mess with that side. She stated that everything happened on the left. She had pain down her neck and around the ribs at the bottom of her breast and into the heart area and that was when it grabbed (2021). It was still there but not as strong, it could get strong sometimes but she knew it was there but sometimes it could get really tight and other times she was doing her daily thing and nothing. It was a weird feeling like a boob hurt but behind that and they gave her a lidocaine patch and she thought what the hell for the pain was behind the boob. Moving around she could feel it and it was hard to describe, it really was. She also had 2 EKGs done, 1 in the urgent care and 1 in the hospital on Sunday (29Aug2021). She said everything was fine and that was when they were like they said it was a possibility it could be that word she could not say, the inflammation around the heart and they said she needed to make an appointment to see her doctor and she was very fortunate he had a cancellation on Wednesday. Patient received the vaccine at pharmacy. She was asking how long could she wait for the 2nd shot, that they want to do another test and she was trying to get an appointment with a cardiologist. She was stuck between a puzzle and doesn't know. She stated that providing information helps everybody, there can be word that this could happen; that whatever the word was she can't pronounce if it is they said male boys have it and she is female and 48 and that is a percentage. The events resulted to emergency room visit and doctor/physician visit. Therapeutic measures were taken as a result of the reported events. The outcome of the events was unknown. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1711720
Sex: F
Age:
State: AZ

Vax Date: 03/12/2021
Onset Date: 03/12/2021
Rec V Date: 09/18/2021
Hospital:

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

Lab Data: Test Date: 20210831; Test Name: Nasal Swab; Test Result: Negative

Allergies:

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: Left arm 6 months later still stuck, ears ringing. Tinnitus now very bad; Left arm 6 months later still stuck, ears ringing. Tinnitus now very bad; This is a spontaneous report from a contactable consumer (patient). A 70-years-old female patient received BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine, dose number unknown, via an unspecified route of administration, administered in left arm on 12Mar2021 07:00, at 70 years of age, (Batch/Lot Number: Ew0150) as single dose for COVID-19 immunization. Medical history included allergy to sulfa drugs from an unknown date. The patient was not diagnosed with COVID-19 prior vaccination. Concomitant medication included estrogens conjugated (PREMARIN) taken for an unspecified indication, since an unknown date. The patient didn't receive any other vaccine within 4 weeks prior to the COVID-19 vaccine. The patient reported that on 12Mar2021 08:00 she experienced left arm stuck, ears ringing, tinnitus. These events were assessed serious as disabling/incapacitating. On 31Aug2021 the patient underwent SARS-CoV-2 test (nasal swab) which was negative. It was reported that 6 months later the left arm was still stuck, ears were still ringing and tinnitus was now very bad. No treatment was administered for the events. At the time of the report the event had not resolved yet. Follow-up attempts are completed. No further information is expected.

Other Meds: PREMARIN

Current Illness:

ID: 1711721
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/18/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Pituitary does not work and take growth hormones/no growth hormones after his pituitary was injured 3 times; Forgets to take the injections daily/does have a difficult time remembering words; He does have problems with his brain function; Cough; Forgetting to take the medication is due psychological; Not have enough energy; Does not feel that great the day of or the day after receiving the COVID vaccine; This is a spontaneous report received from a contactable consumer or other non-health care professional (patient) reported for himself. A male patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunisation. Medical history included glaucoma, tremor (after the Heparin complications he was left with tremors) from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. The patient previously took bnt162b2 for covid-19 immunisation and experienced no adverse event, heparin and experienced poisoned by heparin, left unconscious. Patient stated he was told early on patient may have took a 3rd dose of the Pfizer vaccine because my pituitary does not work and take growth hormones. He states nobody has told him if he needs to come back in 3 weeks or what so he did not know and wanted to call and check on this. He states he had no problem with the 2 doses and although he did not want to take it again, he would if he needs to. Caller took a regular dose of Omnitrope. At the first vaccination visit the caller did not get any helpful information or literature with the vaccine just the card and the follow up appointment. He stated that he has a hard time communicating with his health care professional due to her assistant not liking him. The literature the caller received at his 2nd dose he claims to be very helpful in indicating that he would be a candidate for the 3rd booster dose. Patient has been diagnosed with having no growth hormones after his pituitary was injured 3 times. He stated he actually forgets he was taking his medication although he has no trouble with his treatments he sometimes, or often times, forgets to take the injections daily. Caller states that he does had problems with his brain function but he feels as though it was improving. He did not not know how to explain it. He stated he has a cough but the cough was from a medication that was used due to his Glaucoma that irritated his cough. He does not think it has anything to do with covid and has had the cough since taking the medication. Patient stated he was not on a high dose of his Omnitrope and it stays in his system for 3 days. He claims him forgetting to take the medication is due psychological and due to possibly not wanting to take the medication. Caller also noted that he was poisone by Heparin he took about 2.5 years ago and was left unconscious by himself in the sticks alone. He stated his thinking ability has much improved since then. He does have a difficult time remembering words even though he knows what he wants to say. Caller claims to be doing much better. He states the meds have improved everything with me, I am a lot more clear, I remember names and everything better. Patient stated he did not have enough energy to deal with it in the beginning and it has improved my health in general. Caller reports after the Heparin complications he was left with tremors and when he has to talk about it he sometimes gets those tremors back in his right hand. Caller reports that he has started to write better. Caller stated he would get the booster dose in 28 days. Caller noted that he does not feel that great the day of or the day after receiving the COVID vaccine but he has been through so much more. I am getting better with the other things. No negative but I needed to check with someone who really knew, I was assuming. He questions maybe the wording they asked him before about his medications/condition or booster dosing was not clear. A third dose of the Pfizer-BioNTech COVID-19 Vaccine (0.3 mL) administered at least 28 days following the second dose of this vaccine was authorized for administration to individuals at least 12 years of age who have undergone solid organ transplantation, or who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise. Caller stated that he was unable to get his 2nd dose of the vaccine as scheduled and had to wait 4 weeks nearly 5 weeks to get it. He was not sure if this made a difference or not. He stated that the vaccination site was set up at his local grocery but they were gone for the 2nd dosing round and he had to travel further to get the vaccine. Caller would like to know how he goes about getting the 3rd vaccine. He questions what he should bring when he goes to get the vaccine and if he should bring his medication to prove anything. Treatment was received for the events. The outcome of the events was reported as blood growth hormone decreased, mental disorder, feeling abnormal was unknown and memory impairment, cerebral disorder, asthenia was recovering was cough not recovered. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1711722
Sex: F
Age:
State: NC

Vax Date: 08/11/2021
Onset Date: 08/11/2021
Rec V Date: 09/18/2021
Hospital:

Vax Type: FLUC4
Manufacturer: SEQIRUS, INC.
Vax Name: INFLUENZA (SEASONAL) (FLUCELVAX QUADRIVALENT)
Lot: 276563
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data: Test Date: 20210811; Test Name: blood pressure; Result Unstructured Data: Test Result:Dropped

Allergies:

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

Symptoms: anaphylaxis; lip swelling; Eyes swelling; blood pressure dropped; Heart palpitations; This is a spontaneous report from a contactable healthcare professional. A non-pregnant 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in left arm on 11Aug2021 15:38 (Batch/Lot Number: EW0187) as dose 1, single (at the age of 43 years old) for COVID-19 immunisation. Medical history included allergies: Alpha Gal, all mammal products, shrimp, adhesives and dermatitis contact. There were no concomitant medications. The patient previously took ALEVE and magnesium stearate, multivitamins and experienced allergies. Nine minutes after injection (11Aug2021): itching on hands, arms, legs. At 15 min: lip swelling, eyes swelling, blood pressure dropped. It was in anaphylaxis and admitted to ER. Treatment: Epinephrine, Steroids, albuterol breathing treatment. Prior to vaccination, the patient was not diagnosed with COVID-19 and not been tested for COVID-19. The event was reported as life-threatening except for palpitations. The outcome of palpitation was unknown and other events was recovering.; Sender's Comments: Based on plausible dose- event relationship post-vaccination and the causal role of BNT162B2 vaccine cannot be excluded for the reported events. Underlying hypertension could be contributory to the reported 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:

Current Illness:

ID: 1711723
Sex: F
Age:
State: OH

Vax Date:
Onset Date:
Rec V Date: 09/18/2021
Hospital:

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

Lab Data: Test Name: COVID; Result Unstructured Data: Test Result: still got covid.

Allergies:

Symptom List: Pyrexia, White blood cell count decreased

Symptoms: his wife was vaccinated but still got CoVid; his wife was vaccinated but still got Covid; This is a spontaneous report from a program via a non-contactable other, HCP reported for a female patient. A female patient of an unspecified age received a dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on an unspecified date, as unknown, a single dose for COVID-19 immunization. The reporter stated the patient was vaccinated but still got COVID on an unspecified date. The reporter went on to express wishes that hopes everyone from Pfizer gets COVID and wondered how we could sleep with ourselves for inventing such a terrible vaccine and went on with some profanities and hung up. The patient underwent lab test and procedure included COVID with result still got covid on an unspecified date. Outcome of the events was unknown. No follow-up attempts are Possible. Information on Lot/batch number cannot be obtained. Sender's Comments: As there is limited information in the case provided, the causal association between the event Covid 19 and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.

Other Meds:

Current Illness:

ID: 1711724
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/18/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Pharyngeal swelling

Symptoms: stroke; heart attack; he has a lot of heart problems; This is a spontaneous report from a contactable consumer or other non hcp. A 69-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number was not reported) via an unspecified route of administration on an unspecified date as single dose and First dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number was not reported) via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced stroke, heart attack, he has a lot of heart problems. Clinical course was reported as patient was 69-year-old patients who wants to know when he and his wife will get their booster shot. He has a lot of heart problems. he had a stroke and a couple of heart attack. The clinical outcome of the event was unknown. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1711725
Sex: F
Age:
State: FL

Vax Date: 09/01/2021
Onset Date: 09/02/2021
Rec V Date: 09/18/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Abdominal pain, Chills, Sleep disorder

Symptoms: red bumps on both arms; The lady who administered the vaccine did not go deeper in injecting the vaccine; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer (patient's mother) reported for her (daughter, the patient). A 12-year-old female patient received first dose of bnt162b2 (Pfizer BioNTech covid-19 mRNA vaccine, Solution for injection), via an unspecified route on 01Sep2021, as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 02Sep2021 after the first dose of vaccine, reporter stated that the lady who administered the vaccine did not go deeper in injecting the vaccine and could have been an error on administration since today on 02Sep2021, patient started experiencing really red bumps on both of their arms (she and her daughter) where the injection site was. Reporter mentioned that her husband and two more daughters had the complete doses of the vaccine but did not have any adverse reactions and clarified that they were all fine. The clinical outcome of the events was unknown. The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow-up.

Other Meds:

Current Illness:

ID: 1711726
Sex: F
Age:
State: TN

Vax Date: 08/29/2021
Onset Date: 08/29/2021
Rec V Date: 09/18/2021
Hospital:

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

Lab Data: Test Date: 20210507; Test Name: Nasal Swab; Test Result: Negative

Allergies:

Symptom List: Diarrhoea, Nasal congestion

Symptoms: Flutter in heart; Metal taste in mouth; Nauseous; diarrhea; Fuzzy head; loss mental focus; Bump appeared on bottom lip; This is a spontaneous report from a non-contactable consumer (patient). A 43-year-old female patient received the first dose of bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration, administered in Arm Right on 29Aug2021 13:00 (Lot Number: FD8448) as dose 1, single for COVID-19 immunisation. Medical history included known allergies to Morphine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. There were no concomitant medications. COVID test (Nasal Swab) on 07May2021 was negative. On 29Aug2021 after 30min of shot (at 13:30), patient experienced a metal taste in mouth; flutter in heart lasted a day; nauseous and diarrhea lasted 4 days; fuzzy head and loss mental focus that lasted 5 days; and a bump appeared on bottom lip. The adverse events result in Doctor or other healthcare professional office/clinic visit. The outcome of the event 'Flutter in heart' was recovered on 30Aug2021 13:30, for 'nauseous and diarrhea' was recovered on 02Sep2021 13:30, for 'Fuzzy head' and 'loss of mental focus' was recovered on 03Sep2021 13:30, for the other events was recovering. No follow up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1711727
Sex: F
Age:
State: CA

Vax Date: 09/01/2021
Onset Date: 09/01/2021
Rec V Date: 09/18/2021
Hospital:

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

Lab Data: Test Date: 2021; Test Name: Oxygen; Result Unstructured Data: Test Result: 99%; Test Date: 2021; Test Name: PCR; Result Unstructured Data: Test Result: Negative; Test Date: 20210903; Test Name: PCR; Result Unstructured Data: Test Result: Positive.

Allergies:

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

Symptoms: tested positive on the PCR/Tested positive of the covid-19 virus after the both the doses; tested positive on the PCR/Tested positive of the covid-19 virus after the both the doses; sore arm; chills; couldn't sleep well/ couldn't sleep really well; felt feverish; fatigue; Injection site pain; Sleeplessness; This is a spontaneous report from a Contactable Consumer. A 61-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot number: FA6780), via an unspecified route of administration on 01Sep2021 age at vaccination was 61 years as DOSE 2, SINGLE for covid-19 immunisation. Medical history and concomitant medications were not reported. Historical vaccine includes the patient received first dose of BNT162B2 Pfizer Covid 19 vaccine, Batch/Lot number: FA6780 on an unspecified date for COVID-19 immunization had side effect of sore arm. In Sep2021, the patient had sore arm, chills, couldn't sleep well/couldn't sleep really well, felt feverish, fatigue, injection site pain, and sleeplessness. On 03Sep2021, the patient tested positive on the PCR for the covid-19 virus after the both the doses. The reporter reported that, I have recently gotten vaccinated, my first dose a little over 3 weeks ago and my second dose Wednesday. On Wednesday night, I had a sore arm which is normal for me because I had it with the first one, but then I started with chills throughout the night. I couldn't sleep well, felt feverish. Around 5am, about 16 hours after injection, I took 1 Tylenol felt better almost immediately and said awesome I was just having side effects. To be safe, I went to go get tested around noon time the next feeling just fine back to myself, took another Tylenol as a precaution because I had the fatigue, the whole 9 yards. I felt fine yesterday for the rest of the day, I thought great my side effects are over, until I got a phone call this morning from the state of that said you tested positive on the PCR, you tested positive, but I'm feeling back to myself now, like okay. I went and got another PCR test that had someone else do it and that came back negative. I'm feeling just fine, oxygen at 99%, everything is normal about me, but I'm really concerned did I have covid. The lab data included oxygen saturation was 99% on an unspecified date in 2021, PCR test negative on an unspecified date in 2021, and PCR test positive on 03Sep2021. The treatment medication included TYLENOL for fever. Outcome of the events sore arm, chills, I couldn't sleep well/couldn't sleep really well, felt feverish, fatigue, injection site pain, and sleeplessness were recovered in 2021 and other events was unknown. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1711728
Sex: F
Age:
State: AK

Vax Date: 04/27/2021
Onset Date: 05/31/2021
Rec V Date: 09/18/2021
Hospital: Y

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

Lab Data: Test Date: 20210526; Test Name: COVID-19 test via Nasal Swab; Test Result: Negative

Allergies:

Symptom List: Rash, Urticaria

Symptoms: Pulmonary Embolus; Sudden Cardiac Arrest; Myocarditis; Pericarditis; This is a spontaneous report from a contactable consumer (patient herself). A 45-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in the right arm on 27Apr2021 at 09:45 at the age of 45 years old (Batch/Lot Number: EN6206, Expiration date: unknown) as dose 2, single for COVID-19 immunization. The vaccination facility type was the physician/doctor's office/urgent care. The patient was not pregnant at the time of vaccination. Relevant medical history included anxiety and migraines, both from an unknown date and unknown if ongoing. The patient had no known allergies. The patient had no COVID-19 prior vaccination. The patient had no other vaccine in four weeks. Concomitant medications in two weeks included fluoxetine; minocycline; nortriptyline; and "Spironolac" (as reported); all taken for an unspecified indication, start and stop date were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in the right arm on 30Mar2021 at 09:00 AM at the age of 45 years old (Batch/Lot number: EN6202, Expiration date: unknown), as dose 1, single for COVID-19 immunization. On 31May2021 at 08:00, the patient experienced pulmonary embolus, sudden cardiac arrest, myocarditis, and pericarditis. The adverse events (AEs) resulted in both doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. This report was considered serious, as the events resulted in hospitalization and disability and were also considered life threatening. The patient was hospitalized for pulmonary embolus, sudden cardiac arrest, myocarditis, and pericarditis on an unspecified date for 6 days. The patient underwent lab test and procedure, which included COVID-19 test via nasal swab: negative on 26May2021. Therapeutic measures were taken as a result of pulmonary embolus, sudden cardiac arrest, myocarditis, and pericarditis, which included resuscitation, blood thinners, colchicine, and implantable cardioverter defibrillator (ICD). The patient had recovered with sequelae from all the events on an unspecified date in 2021.

Other Meds: FLUOXETINE; MINOCYCLINE; NORTRIPTYLINE

Current Illness:

ID: 1711729
Sex: M
Age:
State: CA

Vax Date: 03/04/2021
Onset Date: 03/30/2021
Rec V Date: 09/18/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Blood pressure decreased, Chest pain, Chills, Confusional state, Decreased appetite

Symptoms: Within several weeks my hair began to fall out in general, not patches.; This is a spontaneous report from a contactable consumer. This 68-year-old male consumer (patient) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot Number: ENG205), dose 1 via an unspecified route of administration, administered in Arm Right on 04Mar2021 (at the age of 68-year-old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included hiv infection from an unknown date and unknown if ongoing Other medical history: HIV, rubber sensitivity from an unknown date and unknown if ongoing Known allergies: Latex, drug hypersensitivity from an unknown date and unknown if ongoing Known allergies: Penicillan. The patient experienced alopecia (within several weeks my hair began to fall out in general, not patches) on 30Mar2021 with outcome of recovered with sequelae. Adverse events was classified as serious: Disability or permanent damage Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1711730
Sex: M
Age:
State: NC

Vax Date: 02/10/2021
Onset Date: 02/17/2021
Rec V Date: 09/18/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025J20-2A
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Dyspnoea, Fatigue, Feeling abnormal, Head discomfort, Headache

Symptoms: I began getting lesions in my mouth and gums.; I began getting lesions in my mouth and gums.; This is a spontaneous report from a contactable consumer (patient). A 71-year-old male patient received the second dose of BNT162B2 (Pfizer-BIONTECH COVID-19 Vaccine), via an unspecified route of administration, administered in the left arm on 10Feb2021 (Batch/Lot Number: EL3249) single, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient did not have COVID prior to vaccination and had no known allergies. The patient received the first dose of BNT162B2 (Pfizer-BIONTECH COVID-19 Vaccine) on 21Jan2021 (Lot number: EK9231) in the left arm. The patient had no other vaccines within four weeks. The patient stated that one week after the second vaccine, on 17Feb2021, he began getting lesions in his mouth and gums. He has consulted an oral surgeon and ENT specialist but have received no answers and no relief from the lesions. Stated that he had never had as much as a cold sore or ulcer in his mouth prior to his injection. He believed that the vaccine had some part in causing the lesions. Treatment for the events included mouthwash and prednisone. The patient was not tested for COVID post vaccination. Outcome of the events was not recovered.

Other Meds:

Current Illness:

ID: 1711731
Sex: F
Age:
State: FL

Vax Date: 05/05/2021
Onset Date: 07/01/2021
Rec V Date: 09/18/2021
Hospital:

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

Lab Data: Test Date: 20210811; Test Name: Nasal Swab; Result Unstructured Data: Test Result:Negative; Comments: Covid test name post vaccination= PCR

Allergies:

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

Symptoms: Lost some movements; Left arm still hurts; This is a spontaneous report from a contactable consumer (patient). A 55-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in the left arm on 05May2021 (as reported) (Batch/Lot Number: Ew0182) as dose 2, single (at the age of 55-years-old) for Covid-19 immunisation. There was no medical history. The patient has unspecified concomitant medications (other medications in two weeks). The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in the left arm on 05May2021 (as reported) at 12:00 AM (Batch/Lot Number: Ek10173) as dose 1, single for Covid-19 immunisation. The patient had no other vaccine in four weeks. The patient lost some movements and left arm still hurts on 01Jul2021. No treatment was administered for the events. The patient had no Covid prior vaccination. The patient was tested for Covid via nasal swab (PCR) on 11Aug2021 and resulted negative. The events had not resolved.

Other Meds:

Current Illness:

ID: 1711732
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/18/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Nausea, Pain, Pain in extremity, Paraesthesia oral, Pyrexia

Symptoms: Rash; This is a spontaneous report received from a contactable consumer (mother). This consumer re-ported behalf of female patient (daughter) in response to Non HCP telephonic follow up activity that included. A 35-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: not provided) via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. Medical history and concomitant medications were not reported. It was reported that she took Pfizer covid vaccine and got a rash. Outcome of event was unknown. Follow-up attempts were completed. No further information is expected; information about lot/batch number could not be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101152710

Other Meds:

Current Illness:

ID: 1711733
Sex: F
Age:
State: CT

Vax Date: 04/12/2021
Onset Date: 04/15/2021
Rec V Date: 09/18/2021
Hospital: Y

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

Lab Data:

Allergies:

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

Symptoms: lethargic; trouble breathing; fever; Sore arm at injection site; tiredness; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received bnt162b2 (Pfizer COVID 19 ), dose 1 via an unspecified route of administration, administered in left arm on 12Apr2021 11:15 (Lot Number: EW0158) as dose 1, single at the age of 61-year-old for COVID-19 immunisation. The patient was not pregnant. Medical history included renal hypertension, osteoarthritis, born with one kidney, shellfish allergy, insulin allergy. Concomitant medications included pravastatin; candesartan cilexetil; chlorthalidone, all taken for an unspecified indication in two weeks. No other vaccine in four weeks. The patient experienced sore arm at injection site, tiredness on 15Apr2021. About a week later she was lethargic and had a fever, trouble breathing. Had to call ambulance to be transported to the hospital and was admitted. AE resulted in emergency room/department, hospitalization for 9 days, life threatening illness (immediate risk of death from the event). Treatment received for the events which included oxygen, medication. No COVID prior vaccination. It was unknown If COVID tested post vaccination. The outcome of events was recovering.

Other Meds: PRAVASTATIN; CANDESARTAN CILEXETIL; CHLORTHALIDONE

Current Illness:

ID: 1711734
Sex: F
Age:
State: NV

Vax Date: 08/08/2021
Onset Date: 08/09/2021
Rec V Date: 09/18/2021
Hospital:

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

Lab Data: Test Date: 20210901; Test Name: Nasal Swab/ PCR, covid test; Test Result: Negative

Allergies:

Symptom List: Ear pain, Hypoaesthesia

Symptoms: Mast Cell Activation syndrome and POTS returned 24 hours after the vaccine; Mast Cell Activation syndrome and POTS returned 24 hours after the vaccine; Mast Cell Activation syndrome and POTS returned 24 hours after the vaccine; I have developed hives on my stomach and itching; I have developed hives on my stomach and itching; This is a spontaneous report from a contactable other health care professional, (the patient reported for self). A 46-years-old (non-pregnant) female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: EYO584), dose 1 via an unspecified route of administration, administered in arm left on 08Aug2021 13:00 (at the age of 46-years-old) as dose 1, single for COVID-19 immunization. Medical history included lyme disease, mast cell activation syndrome, Vestibular Migraines, Postural Orthostatic Tachycardia syndrome (POTS) and Known allergies includes: allergy to Sulfa based drugs and foods. Concomitant medications (Other medications in two weeks) includes: loratadine (CLARITINE), multivitamin and mineral taken for unspecified indication from unknown dates. The patient did not receive any other vaccine in four weeks. The patient did not have COVID prior to the vaccination. On 09Aug2021 08:00, the patient developed hives on stomach and itching. Mast Cell Activation syndrome and POTS returned after the vaccine when it had previously been gone. The events resulted in doctor or other healthcare professional office/clinic visit. Post vaccination, on 01Sep2021, the patient underwent lab test and procedures which includes: Nasal Swab/ PCR, covid test which showed negative result. The patient received mast cell stabalizer and antihistamines as treatment for the events. The outcome of the events was not recovered. No follow-up attempts were needed. No further information was expected. ; Sender's Comments: Based on the temporal relation, the association between the events of Mast Cell activation Syndrome and Postural Orthostatic Tachycardia Syndrome and the suspect product of BNT162B2 cannot be completely ruled out. The patient's medical history of the reported events is a confounding factor 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 ad-verse 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: CLARITINE

Current Illness:

ID: 1711735
Sex: M
Age:
State: FL

Vax Date: 08/27/2021
Onset Date: 08/28/2021
Rec V Date: 09/18/2021
Hospital:

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

Lab Data: Test Name: CAT scan; Result Unstructured Data: Test Result:Done; Comments: Muscle, head and neck CAT scan

Allergies:

Symptom List: Abdominal pain upper, Dizziness, Dysgeusia

Symptoms: left side of his face feeling paralyzed; left eye smaller; left side neck pain; facial nerve swollen; earache and behind ear as well; Carotid artery swollen and painful; Neck stiffness; Left arm soreness; Carotid artery swollen and painful; muscle tenderness; headache on the left side of my head; This is a spontaneous report from a contactable consumer (reported for himself). A 34-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: FC3180/Batch number was not reported), dose 1 via an unspecified route of administration, administered in arm left on 27Aug2021 (at the age of 34-year-old) as dose 1, single for covid-19 immunisation. Medical history included psoriasis (Inverse Psoriasis), psoriasis (Psoriasis Arthritis) and compartment syndrome from an unknown date and unknown if ongoing. Concomitant medications included otezla (APREMILAST) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient has no reported allergies. The consumer reported that the day after patient received the vaccine, on 28Aug2021, he woke up with a headache on the left side of his head, same side where the vaccine was injected in his left arm. Next noticed his left eye smaller, left side of his face feeling paralyzed, left side neck pain, facial nerve swollen, earache and behind ear as well. Left arm soreness and muscle tenderness. Carotid artery swollen and painful. Neck stiffness. The event left side of his face feeling paralyzed was assessed as serious (medically significant). The reporter stated the events result in emergency room/department or urgent care. Therapeutic measures were taken as a result of events included treatment with Anti-inflammatory drugs. On an unknown date, the patient underwent muscle, Head and Neck Cat Scan. The outcome of the events was not resolved. No follow-up attempts are possible. No further information is expected.

Other Meds: OTEZLA

Current Illness:

ID: 1711736
Sex: F
Age:
State: OH

Vax Date: 09/01/2021
Onset Date: 09/02/2021
Rec V Date: 09/18/2021
Hospital:

Vax Type: RV1
Manufacturer: GLAXOSMITHKLINE BIOLOGICALS
Vax Name: ROTAVIRUS (ROTARIX)
Lot:
Dose Series: 1
Vax Route: PO
Vax Site: MO

Lab Data: Test Date: 20210901; Test Name: Nasal Swab; Test Result: Negative

Allergies:

Symptom List: Blood pressure increased, Chest discomfort, Heart rate increased

Symptoms: Post menopausal Vaginal bleeding x1 day beginning night of vaccination; This is a spontaneous report from a contactable consumer (patient). A 65-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number and expiration dates were not reported), dose 1 via unknown route administration at left arm on 01Sep2021 at 11:00 am (age at vaccination 65-year-old) as single dose for COVID-19 immunisation. The patient had allergy to sulfa from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient medical history included endometrial cancer with hysterectomy, asthma, hypothyroid, arthritis, retinal detachment and choledocholithiasis from an unknown date and unknown if ongoing. The patient took other medications in two weeks included amlodipine, levothyroxine, ursodiol, tramadol and vitamin B1 from an unknown date for unknown indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient had post-menopausal vaginal bleeding in 1 day beginning night of vaccination on 02Sep2021 at 12:00 am. The patient had not received any treatment for the event. The patient underwent lab tests and procedures which included Sars-cov-2 test (Nasal swab): Negative on 01Sep2021. The Facility where the most recent COVID-19 vaccine administered was Doctor's office/urgent care. The patient did not receive any treatment for the adverse event. The outcome of the event was recovered on an unknown date in 2021. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow-up.

Other Meds: AMLODIPINE BESILATE; LEVOTHYROXINE SODIUM; URSODIOL; TRAMADOL; VITAMIN B1 [THIAMINE]

Current Illness:

ID: 1711737
Sex: F
Age:
State: MD

Vax Date: 04/09/2021
Onset Date: 04/09/2021
Rec V Date: 09/18/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot: Eh9899
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data: Test Date: 20210420; Test Name: CTA head W/WO Contrast; Result Unstructured Data: Test Result:No health problems found; Test Date: 2021; Test Name: EMG; Result Unstructured Data: Test Result:No health problems found; Test Date: 20210420; Test Name: Lumbar Puncture; Result Unstructured Data: Test Result:No health problems found

Allergies:

Symptom List: Injection site erythema, Injection site pruritus, Injection site swelling, Lymph node pain, Lymphadenopathy

Symptoms: Neurological disorder; Like my hands get tired quickly; Woke up several time at night; My feet and toes are cold; Weakness/I don't have much energy to keep my hands up a long time; Numbness and Pins and needles on legs and foots/numbness on my wrist and fingers; Numbness and Pins and needles on legs and foots/Pins and needles on my leap; This is a spontaneous case received from a contactable consumer (patient herself). A 31-year-old non-pregnant female patient received first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EWO158), via an unspecified route of administration on 09Apr2021 at 14:45 (age at vaccination 31-year-old) as DOSE 1, SINGLE for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. The patient's medical history, known allergies and concomitant medications was not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 09Apr2021 14:50, the patient experienced numbness and pins and needles on legs and foot all the time when she sits down or lay down on her bed. On 10Apr2021 04:00, the patient woke up several time at night because of numbness/pins and needles. The patient stated that she had same symptoms and additional weakness, her feet and toes were cold, pins and needles on her leap that last few seconds. On 13Apr2021, the patient experienced numbness on her wrist and fingers. On 17Apr2021, the patient stated she had pins and needles at night, it was stronger, and she do not have much energy to keep hands up a long time, like her hands get tired quickly. On 02Sep2021, the patient stated she still have same problems. The Next EMG exam was scheduled on 10Sep. She had visited several Allergists, Neurologists but no health issue was found except neurological disorder caused by the vaccine. On 20Apr2021, the patient visited emergency room. The patient underwent lab test and procedures which included CTA Head W/WO Contrast and lumbar puncture and the results was no health problems found. The treatment for the events was unknown. Seriousness of the events was reported as disabling/incapacitating. The outcome of the events was not recovered.

Other Meds:

Current Illness:

ID: 1711738
Sex: F
Age:
State: CA

Vax Date: 01/01/2021
Onset Date: 01/01/2021
Rec V Date: 09/18/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Unevaluable event

Symptoms: Then I got severe cardiac arrhythmias first time ever in my life. 20x PVC per minute. I still have it; after second dose really sick about 4 days.; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on Jan2021, as a single dose for COVID-19 immunization at hospital. The patient was not pregnant at the time of vaccination. The patient's medical history included hypothyroid. Concomitant medications were not reported. Past drug included morphine (known allergy: morphine). The patient was not diagnosed with COVID prior vaccination. The patient was not tested for COVID post vaccination. The patient reported that after second dose she really sick about 4 days. Then she got severe cardiac arrhythmias first time ever in my life. 20x PVC per minute. She still had it on an unspecified date in Jan2021. The patient did not receive any treatment for the events. Outcome of the events was not recovered. The lot number for BNT162B2 was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1711739
Sex: M
Age:
State: MD

Vax Date: 03/31/2021
Onset Date: 04/02/2021
Rec V Date: 09/18/2021
Hospital: Y

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

Lab Data: Test Date: 2021; Test Name: diagnostics test; Result Unstructured Data: Test Result:Bacterial endocarditis which threw septic emboli; Comments: Bacterial endocarditis which threw septic emboli to his brain, heart, spleen and lower extremities.; Test Date: 20210822; Test Name: COVID-19 rapid test; Test Result: Negative ; Comments: Nasal Swab

Allergies:

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

Symptoms: he underwent open heart surgery on 01Sep2021 to replace his mitral valve; he was found down at home on 26Aug2021; Not feel well; 4 months of decreasing exercise tolerance; ending with a URI; fever; chills; stroke/MI; Bacterial endocarditis; This is a spontaneous report from a contactable consumer. A 70-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: ER8727), via an unspecified route of administration, administered in right arm on 31Mar2021 (at the age of 70 years old) as dose 2, single for COVID-19 immunization. Medical history included hypertension, and hyperlipidaemia from an unknown date. The patient had no history of COVID prior to vaccination. The patient previously received the first dose of BNT162B2 (lot number: EN6206), on 10Mar2021, administered on left arm, for COVID-19 immunization. Concomitant medications included acetylsalicylic acid (ASPIRIN (E.C.)); rosuvastatin calcium (CRESTOR); telmisartan (MICARDIS); ascorbic acid (VITAMIN C); and vitamin D, all taken for an unspecified indication, start and stop date were not reported. Two days post second Pfizer COVID-19 vaccine, on 02Apr2021, the patient began to not feel well. He experienced 4 months of decreasing exercise tolerance ending with a URI, fever, chills, stroke/MI. He was also found down at home on 26Aug2021 and was taken to the hospital. Diagnostic tests in 2021 revealed bacterial endocarditis which threw septic emboli to his brain, heart, spleen and lower extremities. He underwent open heart surgery on 01Sep2021 to replace his mitral valve. He was in the ICU recovering at the time of the report. The patient was hospitalized for the events for 11 days. The events resulted in a doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event), and disability or permanent damage. The patient underwent diagnostic tests in 2021: Bacterial endocarditis which threw septic emboli to his brain, heart, spleen and lower extremities; and COVID-19 rapid test: negative on 22Aug2021 (Nasal Swab). The patient was recovering from the events.

Other Meds: ASPIRIN (E.C.); CRESTOR; MICARDIS; VITAMIN C [ASCORBIC ACID]; VITAMIN D [VITAMIN D NOS]

Current Illness:

ID: 1711740
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/18/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site pain, Pain

Symptoms: Bell's Palsey after receiving the vaccine; This is a spontaneous report from a Pfizer-sponsored program. A non-contactable consumer reported for a patient. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 Vaccine, solution for injection, Batch/lot number was not reported), via an unspecified route of administration, on an unspecified date at a dose number unknown, single for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unspecified date, the patient developed Bell's Palsey. The reporter stated a family member developed Bell's Palsey after receiving the vaccine. The reporter had first hand knowledge of the patient and was reporting on a specific patient. The reporter stated that she is not going to get the vaccine. The outcome of the event was unknown. No follow up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1711741
Sex: F
Age:
State:

Vax Date:
Onset Date: 07/15/2021
Rec V Date: 09/18/2021
Hospital:

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

Lab Data: Test Date: 20210715; Test Name: Covid-19; Test Result: Positive

Allergies:

Symptom List: Injection site pain, Menorrhagia

Symptoms: Rheumatoid arthritis flare up; COVID-19; drug ineffective; This is a solicited report based on information received by Pfizer (Mfr. Control No.: 21K-163-4061179-00). A contactable consumer (patient) reported on herself. A 53-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and expiration date: was not reported), dose 1 intramuscular on an unspecified date as DOSE 1, SINGLE for COVID-19 immunisation; upadacitinib (RINVOQ), oral from an unspecified date (Batch/Lot number and expiration date: was not reported) to an unspecified date, at unspecified dose for moderate to severe Rheumatoid Arthritis. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced rheumatoid arthritis flare up. On 15Jul2021, the patient experienced COVID-19. The patient underwent lab tests and procedures which included COVID-19: positive on 15Jul2021. The outcome for the events was unknown. The reporter's causality for the events of Neck Procedure, COVID-19, and Rheumatoid Arthritis Flare with RINVOQ (UPADACITINIB) was not provided. AbbVie's opinion is that there is no reasonable possibility that the events of Neck Procedure, COVID-19 and Rheumatoid Arthritis Flare are related to RINVOQ (UPADACITINIB). The reporter's causality for the events of COVID-19, and Rheumatoid Arthritis Flare with PFIZER BIONTECH COVID-19 VACCINE was assessed as possible. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events DI, Covid 19, Ra aggravated and suspect drug BNT162B2 cannot be excluded The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Other Meds:

Current Illness:

ID: 1711742
Sex: F
Age:
State: CA

Vax Date: 08/01/2021
Onset Date: 08/19/2021
Rec V Date: 09/18/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: faint; I had sore arm; I had sore arm with numbness; I had sore arm with numbness and tingling; Sore throat; running nose; Chills; Headache; Weakness; body aches/my body is in a lot of pain; joints pain; dizziness; nausea; This is a spontaneous report from a contactable other hcp for herself. A 48-years-old female patient (patient was not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: FC31eZ, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on unspecified date of Aug2021 (age at vaccination was 48 years) as dose 1, single for COVID-19 immunization. The patient's medical history included psoriasis from an unknown date. The patient did not have any known allergies. The patient did not receive any concomitant medications or other medications in two weeks. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 19Aug2021 at 15:00 immediate after vaccine patient had sore arm with numbness and tingling for 2 days, sore throat , running nose , chills , headache, weakness. After 24 hours patient start having body aches, joints pain with dizziness, faint, and nausea, weakness from that day to present. Patient did the vaccine 17 days ago and her body was in a lot of pain, joints pain, patient had days when she couldn't get out of bed. Patient had to call in to work multiple time because she couldn't function. Daily she had a lot joints pain all over her body. Treatment was referral to rheumatologist for treatment of psoria. Patient visit the clinic. Therapeutic measures were taken as a result of faint, i had sore arm, i had sore arm with numbness, i had sore arm with numbness and tingling, sore throat, running nose, chills, headache, weakness, body aches/my body is in a lot of pain , joints pain, dizziness and nausea. The outcome of the events i had sore arm and i had sore arm with numbness was recovered on 21Aug2021. Rest outcome of all event was not recovered.; Sender's Comments: Based on available information, there is reasonable possibility of causal association between the event syncope and the suspect drug BNT162B2

Other Meds:

Current Illness:

ID: 1711743
Sex: F
Age:
State: AZ

Vax Date: 07/18/2021
Onset Date: 07/29/2021
Rec V Date: 09/18/2021
Hospital: Y

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

Lab Data:

Allergies:

Symptom List: Nausea, Pain in extremity, Pyrexia

Symptoms: Strangling feeling in esophagus with productive phlegm; difficulty swallowing; chest, neck, and head (eyes, sinus, ear, under the ears in neck area) pressure; extreme dryness of the mouth, throat, and intestines;; numbness and tingling of the head; numbness and tingling of the head; dizziness; shortness of breath; muscle spasms in legs and back; Strangling feeling in esophagus with productive phlegm; dehydration; weakness; hypoglycemia; left sided salivary gland infection; This is a spontaneous report from a contactable nurse (patient). A 37-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EW0179, Expiration date was not reported) via an unspecified route of administration, administered in arm left on 18Jul2021 at 16:00 (age at vaccination: 37-years-old) as dose 2, single for COVID-19 immunization (pharmacy or drug store). The patient medical history included hypothyroidism, gastritis, TB in right salivary gland, pneumonia, bronchitis, and influenza. The patient was not pregnant at the time of vaccination. The patient had previously taken first dose of bnt162b2 (PFIZ-ER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EW0179, Expiry date was not reported) via an unspecified route of administration, administered in arm right on 27Jun2021 at 16:00 (age at vaccination: 37-years-old) as dose 1, single for COVID-19 immunization and had experienced warm feeling, nausea. The patient had no known allergies. The patient concomitant medications included levothyroxine sodium (SYNTHROID); spironolactone (SPIRONOLACTONE); multivitamin. On 29Jul2021 at 19:30, the patient was hospitalized for 2 days and had experienced strangling feeling in esophagus with productive phlegm, difficulty swallowing, chest, neck, and head (eyes, sinus, ear, under the ears in neck area) pressure; extreme dryness of the mouth, throat, and intestines; numbness and tingling of the head, dizziness, shortness of breath, muscle spasms in legs and back, left sided salivary gland infection, dehydration, weakness, hypoglycemia. Therapeutic measures were taken as a result of strangling feeling in esophagus with productive phlegm, difficulty swallowing, chest, neck, and head (eyes, sinus, ear, under the ears in neck area) pressure; extreme dryness of the mouth, throat, and intestines; numbness and tingling of the head, dizziness, shortness of breath, muscle spasms in legs and back, left sided salivary gland infection, dehydration, weakness, hypoglycemia and included Decadron, Normal Saline. The patient was hospitalized for 2 days. Adverse events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care and hospitalization. The patient had not received any other vaccine within 4 weeks. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. The outcome of the events was recovering.; Sender's Comments: As there is limited information in the case provided, the causal association between the event Vaccina-tion failure, COVID-19 and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Other Meds: SYNTHROID; SPIRONOLACTONE

Current Illness:

ID: 1711744
Sex: F
Age:
State:

Vax Date: 08/18/2021
Onset Date:
Rec V Date: 09/18/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: Rheumatoid arthritis; Foot surgery; Eye operation; Fatigue; Energy decreased; Upper extremity dysfunction; Postoperative complication; Difficulty in walking; Filmy visionDifficulty focusing eyes; Foot pain; Pain in hand; Infection; Lower extremity dysfunction; This is a solicited report from a contactable consumer (patient) based on information received by Pfizer from a company (Mfr. Control No.:21K-163-3829982-00). A 66-year-old (pending clarification) female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 2 intramuscular on 18Aug2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at unspecified dose for moderate to severe rheumatoid arthritis. On 28Jul2021, patient received first dose COVID-19 vaccine manufactured by Pfizer for Covid-19 Immunisation intramuscularly. The patient medical history was not reported. Concomitant medications included sulfasalazine; vitamins nos. The patient experienced rheumatoid arthritis on an unspecified date with outcome of unknow, foot surgery on an unspecified date with outcome of recovering , eye operation on an unspecified date with outcome of unknown , fatigue on an unspecified date with outcome of not recovered , energy decreased on an unspecified date with outcome of unknown , upper extremity dysfunction on an unspecified date with outcome of not recovered , lower extremity dysfunction in 2021 with outcome of not recovered , postoperative complication on an unspecified date with outcome of not recovered , difficulty in walking on an unspecified date with outcome of not recovered, filmy vision/ difficulty focusing eyes on an unspecified date with outcome of not recovered , foot pain on an unspecified date with outcome of recovering , pain in hand on an unspecified date with outcome of not recovered , infection in 2021 with outcome of unknown. The action taken in response to the events for adalimumab was unknown. Clinical course: Solicited report by a consumer of a 66-year-old female with events of big left toe amputated from rheumatoid arthritis/no big toe on it cause toes to bunch up, right foot surgery and eye surgery and on-serious tired all the time/feeling fatigued, no energy anymore, left hand had lot of trouble things up/could barely put fingers together pick up a pill and could only use hands about 20 percent of the left hand. Problems with left foot/four toes of left foot really bad, eyes were getting worse after first surgery, that there was a film over eyes. Hard to walk, hard to focus on an object/screen, foot pain. Pain in hands/hands were getting bad and not look any better and infection with Humira (Adalimumab). There was no reported medical history. On unknown dates, the patient experienced big lift toe amputated from rheumatoid arthritis/no big toe on it and causes toes to bunch up, right foot surgery, eye surgery, tired all the time /feeling fatigued, no energy anymore, left hand had lot of trouble picking things up/could barely put use hands about 20 percent of the left hand, eyes were getting worse after first surgery, that there was film over eyes, hard to talk, hard to focus an object or screen, foot pin and pain in hands/hands were getting really bad and not look any better. In 2021, the patient experienced problems with left foot/four foot/four toes of left foot really bad infection. Pfizer BioNTech Covid-19 Vaccine (Tozinameran) was considered suspect. The patient had to go off Humira for her right foot surgery, and she said she could absolutely tell a difference with her pain. In Mar2021, they took the pins out, rebuilt her whole right foot and her big toe was fused, and her foot was so much better. She was so happy with her right foot it was like it was back to normal and so she was walking more on that side. She had problems with her left foot in 2021, she did not have a big toe, it was amputated. Since there was no big toe on it, it caused her toes to bunch up, and makes it really hard to walk. Physician looked at her hands and they did not look any better but they did not look any worse, she could use her hands about twenty percent of her left hand, she could barely put her fingers together pick up a pill and had a lot of trouble in picked things up. She reported her eyes were getting worse after her first surgery, that there was a film over her eyes. It was hard to focus on an object or screen. She did not have a big toe of left foot, and the other four toes were really bad. She stopped her Humira and methotrexate. Physician put her on a low dose of steroids for a few weeks, she took them all and she was finished and she actually felt better. The last time she stopped then it took a while for the Humira to take effect she was so fatigued. In 2021, had surgery for correct her left toes from rheumatoid arthritis. She got a infection, had not started back yet. Causality for surgery was reported as reasonable possibility and outcome was reported as recovering. It was unknown if patient was enrolled in a COVID-19 vaccine trial. On 28Jul2021, patient received first dose COVID-19 vaccine manufactured by Pfizer. On 18Aug2021, patient received second dose COVID-19 vaccine manufactured by Pfizer. The patient was treated with Prednisone and Methotrexate. Causality for Humira (Adalimumab): The reporter's causality for the event(s) of big left toe amputated from rheumatoid arthritis/no big toe on it cause toes to bunch up, right foot surgery and eye surgery and on-serious tired all the time/feeling fatigued no energy anymore, left hand had lot of trouble things up/could barely put fingers together pick up a pill and could only use hands about 20 percent of the left hand, eyes were getting worse after first surgery, that there was film over eyes unknown onset, hard to focus on an object, hard to focus on screen and pain in hands/hands were getting really bad and not look any better with Humira (Adalimumab) was no reasonable possibility. The reporter's casualty for the event(s) of eye surgery, no energy anymore, problems with left foot/four toes of foot really bad, hard to walk. Foot pain and infection was not provided. Company's opinion is that there is no reasonable possibility that the events of big left toe amputated from rheumatoid arthritis /no big toe on it causes toes to bunch up, right foot surgery, eye surgery, tired all the time/feeling fatigued, no energy anymore, left hand had lot of trouble picking things up/could barely put fingers together pick up a pill and could only use hands about 20 percent of the foot hand. Problems with left foot/foot toes of left foot really bad, eyes were getting worse after first surgery, that there was a film over eyes unknown onset, hard to focus on an object or screen, foot pain and pain in hands/hands were getting really bad and not look any better are related Humira (Adalimumab). Company's opinion is that the event of infection not assessable. The reporter considered that no reasonable possibility for event Pain in hand with PFIZER BIONTECH COVID-19, for other events the causality was not reported. The reporter's assessment of the causal relationship of the events other than Pain in hand with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. No Follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information provided in the narrative, a causal association between the suspect drug (bnt162b2) and the events Rheumatoid Arthritis, foot deformity, eye disorder, fatigue, asthenia, musculoskeletal disorder, post procedural complication, gait disturbance, blurred vision, foot pain and infection cannot be completely excluded. However, the causal association between the suspect drug (bnt162b2) and pain in hand is unrelated. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer proc

Other Meds: SULFASALAZINE; VITAMINS NOS

Current Illness:

ID: 1711745
Sex: M
Age:
State: NY

Vax Date: 07/29/2021
Onset Date: 07/29/2021
Rec V Date: 09/18/2021
Hospital:

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

Lab Data: Test Name: Weight; Result Unstructured Data: Test Result:155 lbs; Comments: My weight likes may be 155 (pounds)

Allergies:

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

Symptoms: mild headache; arm pain; Patient had pain at the injection site that was sore and a little stiff; Patient had pain at the injection site that was sore and a little stiff; This is a spontaneous report from a contactable consumer (patient). A 60-years-old male patient received bnt162b2 (PFIZER COVID 19 VACCINE, Solution for injection, Lot Number: EW0217; Expiration Date: 30Sep2021(further not clarified) via intramuscularly, administered in left arm on 29Jul2021 morning like between 9 and 10 O clock (at the age of 60-years-old) as dose 1, single for covid-19 immunisation. The patient's medical history and concomitant medications were none. Vaccination Facility Type was Hospital. Investigation Assessment was no. Prior Vaccinations, no medication received within 4 weeks. On 29Jul2021 in the evening, patient experienced arm pain and mild headache which went away after 2 to 3 days. The patient had pain at the injection site that was sore and a little stiff in 2021. The patient was reading online, and they said most patients can still get headaches months after the shot. The caller wants to know if this was normal. After the first dose the caller had pain at the injection site that was sore and a little stiff. The headache and the arm pain started the evening after the first dose. The event did not require a visit to emergency room and physician office. During his first shot he experienced little arm pain and mild headache, which went away after 2-3 days. Consumer stated that had been taking Aspirin. Consumer stated that the day would both go (voice not clear) like Tylenol and Motrin like he did not know. It might be of 25 milligrams of each (further not clarified). The patient underwent lab tests and procedures which included weight 155 lbs on unspecified date. The outcome of the event mild headache was recovered on 31Jul2021, event arm pain was recovering, and other events was unknown. Follow-up attempts have been completed and no further information is expected.

Other Meds:

Current Illness:

ID: 1711746
Sex: M
Age:
State:

Vax Date:
Onset Date: 08/01/2021
Rec V Date: 09/18/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Nausea

Symptoms: COVID-19; COVID-19; Joint pain; This is a non-interventional study report from the marketing program facilitated collect received from a contactable consumer or other non hcp received by Pfizer. (Manufacturer Control No: 2016-0191204). A 59-years-old male patient received BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN), solution for injection, Batch/Lot number was not reported), via intramuscular on an unspecified date as dose 1, single for covid-19 immunisation and adalimumab (HUMIRA, Solution for injection in pre-filled pen, Batch/Lot number was not reported), subcutaneous from an unspecified date to an unspecified date, at unspecified dose for psoriatic arthropathy. The patient medical history included psoriatic arthritis. The patient's concomitant medications were not reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On an unspecified date in Aug2021, the patient experienced covid-19, joint pain. The outcome of the events was unknown. The reporter assessed the causality between humira and events as Reasonable possibility. The reporter assessed the causality between BNT162B2 and events as possible.; Sender's Comments: Based on the information in the case provided, the causal association between the events Suspected Covid 19 and Arthralgia and the suspect drug BNT162B2 cannot be excluded.

Other Meds:

Current Illness:

ID: 1711747
Sex: M
Age:
State: FL

Vax Date: 08/26/2021
Onset Date: 08/29/2021
Rec V Date: 09/18/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site pain

Symptoms: Periods of fluttering; rapid heart beat; This is a spontaneous report from a non-contactable consumer (patient). A 35-year-old male patient received bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Left arm on 26Aug2021 09:00, at the age of 35-years-old, (Lot Number: FD8448) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included none. The patient's concomitant medications were not reported. On 29Aug2021, the patient experienced periods of fluttering and rapid heart beat. The event involved physician office visit. The outcome of the event was unknown. It was unknown if treatment was received for the events. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1711748
Sex: F
Age:
State:

Vax Date: 12/25/2020
Onset Date:
Rec V Date: 09/18/2021
Hospital:

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

Lab Data: Test Date: 20201124; Test Name: Magnetic resonance imaging; Result Unstructured Data: Test Result:inflammation but nothing torn

Allergies:

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

Symptoms: Light-headed; Fell; Difficulty in walking/could not hardly walk across the floor; This is a solicited report from a contactable consumer (patient) based on the information received by Pfizer (Mfr. Control No.:20K-163-3678612-00). A 62 years old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular at age of 62 years on 14Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation; adalimumab (HUMIRA, Solution for injection in pre-filled pen), subcutaneous from 25Dec2020 (Batch/Lot number was not reported) to 14Apr2021, at 40 mg, daily for moderate to severe adult crohn's. Medical history included inflammation from 24Nov2020 (magnetic resonance imaging). Concomitant medications included oxycodone; tramadol; ondansetron (ZOFRAN); aspirin [acetylsalicylic acid]; vitamin b complex. The patient experienced light-headed in 2021, difficulty in walking/could not hardly walk across the floor in 2021, fell in 2021. The events reported as serious for other medically important condition. Clinical course: Solicited report by a consumer of a 61 year old female with events of total knee replacement/detached part from it/contraption not adhered to bone and fell out/inclined kill patient, going up and down/had to take one step at the time, painful knee/excruciating shoulder pain, rotator cuff surgery and knee swollen and non-serious afraid to go anywhere due to covid, slept a lot, light headed and stumbling around like a drunk for two days, low immune system, tested positive for covid, boyfriend positive for covid, bowels movements three or four times a morning, pharmacy sent humira syringe instead of pen, miserable, knee was not 100 percent, gained weight, lost sense of smell, could not eat, total knee replacement/detached part from it/contraption not adhered to bone and fell out/inclined kill patient, going up and down/had to take one step at the time, light headed, could not hardly walk across the floor, black and blue front back ankle to thigh and in front and back, still knee hurts from where had a knee replacement, little breakout crohn's disease due to stress, elevated white blood count, swollen, scar tissue, lost sense of taste, fell into the chair, shin aches/ pain, headache, nauseous, tender to touch, allergies, nerve pain, arm was sore and pain shoots down shin, physician said it was nerve endings with humira (adalimumab). The patient had a relevant medical history of inflammation. On unknown dates, the patient experienced total knee replacement/detached part from it/contraption not adhered to bone and fell out/inclined kill patient, going up and down/had to take one step at the time, painful knee/excruciating shoulder pain, knee swollen, afraid to go anywhere due to covid, light headed and stumbling around like a drunk for two days, low immune system, tested positive for covid, boyfriend positive for covid, bowels movements three or four times a morning, miserable, knee was not 100 percent, gained weight, lost sense of smell, could not eat, black and blue front back ankle to thigh and in front and back, little breakout CROHN'S disease due to stress, elevated white blood count, swollen, scar tissue, lost sense of taste, shin aches/ pain, headache, tender to touch, allergies, nerve pain and pain shoots down shin, physician said it was nerve endings. in 2021, the patient experienced pharmacy sent HUMIRA syringe instead of pen, light headed, could not hardly walk across the floor, still knee hurts from where had a knee replacement, fell into the chair, nauseous and arm was sore. On 10Apr2021, the patient experienced slept a lot. In Apr2021, the slept a lot resolved. In May2021, the patient experienced rotator cuff surgery. On an unknown date, light headed and stumbling around like a drunk for two days resolved. Pfizer Biontech covid-19 vaccine (TOZINAMERAN) was also considered suspect. The patient had magnetic resonance imaging on the 24Nov2020 that showed inflammation but nothing torn. She had excruciating shoulder pain. She had to have her knee worked on again too. She was afraid to go anywhere due to COVID. Her knee was painful and swollen. Total knee replacement was done. Contraption did not adhere to her bone and fell out. She was in a lot of pain. The physician thought that little two pronged contractions they put in it was shifted. She had surgery to fix detached part from knee replacement. She had total knee replacement on 14Jan2021 and discontinued HUMIRA for six weeks. She was in a lot of pain. She had three CORTISONE shots in her knee and nothing touched the pain. She had a little breakout due to stress. In recovery, the patient got a call from her boyfriend that he had COVID so she was made to wear a mask. She had an emotional breakdown and cried. At 10 AM of the next morning, she was informed that she tested positive for COVID. Something was put in her IV. At 5 PM the patient was released and she was okay. At 9 PM her fever jumped from 101 to 103 and stayed that way all weekend. She woke up with headache and lost sense of smell and taste. She was nauseous as well. The patient thought that it might be from not taking her pain pills. She finally got to go in-person for physical therapy for her knee. Pharmacy sent her a syringe instead of a pen. Physician gave her a PHENERGAN and within a couple of hours she felt better and everything was gone. Her shin was just aching. She was black and blue from the front to the back of ankle to thigh. Physician advised her not to take a bath for six weeks due to possible infection. She massaged knee, so it would be flat. She took about four days' worth of OXYCODONE. She had no other side effects. Her allergies were horrible. She was miserable. She took allergy medicine. She had light headed, stumbling around like a drunk for two days. On 10Apr2021, she slept a lot. Her physician told her knee looks really good and that her pain was nerve pain. She was tender to touch and a little swollen. She had some scar tissue, pain and swelling. Her physician thought about changing her to another medicine from HUMIRA because bowel not normal had three to four times a day and it was diarrhea. Only time her bowel movements were normal when she eats refried beans. She said it was working so she did not want to change. She believes no matter what she did they were not going to be normal. She was used to HUMIRA and it makes her feel so much better. She agreed to have physician contacted. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On 14Apr2021, she received 1st dose COVID-19 Vaccine manufactured by Pfizer. On 04May2021 she received 2nd dose COVID-19 Vaccine manufacture by Pfizer. With the first shot she was so light headed, she could not hardly walk across the floor. She kept going to the right. Fell into the chair next to her. Pharmacist at Walgreens gave her Pfizer vaccine. She took covid vaccine because her immune system was low. The patient had still swollen knee and still hurts from where she had a knee replacement. Inclined kill her, going up or coming down. She did not understand it. Steps she had to take one at a time. She had pain shoots down her shin and the physician said it was nerve endings and that would be go away eventually. Physician told her to keep rubbing vitamin e cream on it. Patient agreed to have physician contacted. In May2021 she had Rotator cuff surgery. Gained weight and Knee had not 100 percent. She also had COVID-19 and her white blood count was elevated. Causality for Humira with difficulty in walking, light-headed and fell per reporter was not reported per Mfr. was no reasonable possibility. The action taken in response to the events difficulty in walking, light-headed and fell for adalimumab was unknown. The outcome of the events difficulty in walking, light-headed and fell was unknown. The reporter's assessment of the causal relationship of the events difficulty in walking, light-headed and fell with the suspect product BNT162B2 was not provided at the time of this report. Since no determination has been received, the case is managed based the company causality assessment. The lo

Other Meds: OXYCODONE; TRAMADOL; ZOFRAN [ONDANSETRON]; ASPIRIN [ACETYLSALICYLIC ACID]; VITAMIN B COMPLEX; HUMIRA

Current Illness:

ID: 1711749
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/18/2021
Hospital:

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

Lab Data: Test Name: Heart beat; Result Unstructured Data: Test Result:Irregular; Test Name: Heart beat; Result Unstructured Data: Test Result:rapid

Allergies:

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

Symptoms: Partial loss of eyesight for short period; Irregular and rapid heartbeat a times; Irregular and rapid heartbeat a times; This is a spontaneous report from a non-contactable consumer (patient). A 59-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. The patient medical history was not reported. The patient had no history of COVID prior vaccination. The patient was not COVID tested post vaccination. There were no concomitant medications. The patient experienced partial loss of eyesight for short period, and irregular and rapid heartbeat a times. The evens resulted in doctor or other healthcare professional office/clinic visit. The outcome of the events was unknown. No follow-up attempts are possible. Information about batch/lot number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1711750
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/18/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Tremor

Symptoms: had miscarriage after vaccination; This is a spontaneous report from a non-contactable consumer via a Pfizer Sponsored Program. This consumer reported for two female patients. This is the first of two reports. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiry date not reported), via an unspecified route of administration, on an unspecified date, as dose number unknown, single, for COVID-19 immunisation. The patient medical history was not reported. There were no concomitant medications. The patient had miscarriage after vaccination on an unspecified date. The outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101154145 different patient, same reporter/product/event

Other Meds:

Current Illness:

ID: 1711751
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/18/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Erythema, Pruritus

Symptoms: patient had miscarriage after vaccination; This is a spontaneous report from a non-contactable consumer via a Pfizer Sponsored Program. This consumer reported for two female patients. This is the second of two reports. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient medical history was not reported. There were no concomitant medications. The patient had miscarriage after vaccination on an unspecified date. The outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101154129 different patient, same reporter/product/event

Other Meds:

Current Illness:

ID: 1711752
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/18/2021
Hospital:

Vax Type: UNK
Manufacturer: UNKNOWN MANUFACTURER
Vax Name: VACCINE NOT SPECIFIED (NO BRAND NAME)
Lot:
Dose Series: UNK
Vax Route: SYR
Vax Site: UN

Lab Data:

Allergies:

Symptom List: Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling, Myalgia

Symptoms: Headache; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: SC3184, expiry date: unknown) via unspecified route of administration, on an unspecified date as dose 1, single for covid-19 immunisation. Patients medical history and concomitant medications were not reported. It seemed like patient got headache since got the (first dose) shot. Patient got it on Sunday and had headache in morning Monday and still had it today (unspecified date). Patient wanted to know what should be done to get rid of the headache. The outcome of event was unknown.

Other Meds:

Current Illness:

ID: 1711753
Sex: F
Age:
State: MD

Vax Date: 08/03/2021
Onset Date: 08/19/2021
Rec V Date: 09/18/2021
Hospital:

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

Lab Data: Test Date: 202108; Test Name: Blood work; Result Unstructured Data: Test Result:Unknown result; Test Date: 202108; Test Name: Chest X-ray; Result Unstructured Data: Test Result:Unknown result; Test Date: 202108; Test Name: EKG; Result Unstructured Data: Test Result:Unknown result

Allergies:

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

Symptoms: severe chest pain; severe chest pain / pressure on right side; severe chest pain / pressure on right side that woke me from sleep; This is a spontaneous report from a non-contactable consumer (patient). A 46-year-old female patient received first dose of bnt162b2 via unspecified route of administration in the arm left, on 03Aug2021 at 17:15 (lot number: fc3180), at the age of 46-years-old, at single dose for COVID-19 immunisation. Medical history included insomnia. Patient was not pregnant at the time of vaccination. Concomitant medication included diphenhydramine hydrochloride (BENADRYL) for unspecified indication, and unspecified vitamins. The patient experienced severe chest pain / pressure on right side that woke the patient from sleep, all on 19Aug2021 at 04:00 am. The events resulted in Doctor or other healthcare professional office/clinic visit, and Emergency room/department or urgent care. Therapeutic measure was taken in response to the events which included unspecified IV med. Laboratory tests included EKG, Chest X-ray, blood work on unspecified date in Aug2021 with unknown results. Outcome of the event was recovered on unspecified date in 2021. No follow-up attempts are possible. No further information is expected.

Other Meds: BENADRYL

Current Illness:

ID: 1711754
Sex: U
Age:
State:

Vax Date: 09/02/2021
Onset Date:
Rec V Date: 09/18/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Asthenia, Chills, Headache, Myalgia

Symptoms: Threw up a couple of time and passed out; I just feel really sick; Extremely tired and weak yesterday and last night I started having numbness and extreme weakness on the right side of my body; Extremely tired and weak yesterday and last night I started having numbness and extreme weakness on the right side of my body; Threw up a couple of time and passed out; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection), dose 1 via an unspecified route of administration on 02Sep2021 (Batch/Lot Number: F3183) as dose 1, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date the patient experienced extremely tired and was weak the previous night and last night he/she started having numbness and extreme weakness on the right side of his/her body and then threw up a couple of time and passed out. The patient still had significant numbness and weakness on his/her right side so, he/she is trying to identify, if he/she need to go into an emergency room or anything or what to do. The patient just felt really sick. The outcome of all the events was unknown.

Other Meds:

Current Illness:

ID: 1711755
Sex: F
Age:
State:

Vax Date: 04/12/2021
Onset Date: 03/01/2021
Rec V Date: 09/18/2021
Hospital:

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

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

Allergies:

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

Symptoms: Stomach upset; Cramps; Gastrointestinal disturbance; Chronic diarrhea; Food allergy; Vaccination site reaction; Loss of voice; Mast cell activation syndrome; This is a solicited report based on the information received by Pfizer (Manufacturer Control No: 21K-163-3794962-00) form a contactable consumer (patient). A 39-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose on 12Apr2021 (Batch/Lot number was not reported) and second dose on 04May2021 (Batch/Lot number was not reported) both via intramuscular as single dose for covid-19 vaccination; upadacitinib (RINVOQ), oral from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at unspecified dose for moderate to severe rheumatoid arthritis. Patient medical history included heart issues (started 2000). Concomitant medications included cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) and epinephrine (EPIPEN) both taken for an unspecified indication, start and stop date were not reported. Solicited report by a consumer of a female patient with events of mast cell activation syndrome, stomach upset, cramping, gastrointestinal disturbance, chronic diarrhea, food allergies/allergic to egg product, possible reaction to covid vaccine and loss of voice with RINVOQ (UPADACITINIB). The patient had a relevant medical history of heart issues from 2000. On unknown dates, the patient experienced stomach upset, cramping, gastrointestinal disturbance, chronic diarrhea, food allergies/allergic to egg product, possible reaction to covid vaccine, vaccination site reaction and loss of voice. In Mar2021, the patient experienced mast cell activation syndrome. On unknown dates, stomach upset, cramping, gastrointestinal disturbance and chronic diarrhea resolved. PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN) was also considered suspect. The patient had two instances, that lasted one day of diarrhea, cramping and overall stomach upset over a period of ten days and her symptoms subsided. She had colonoscopy due to chronic diarrhea and food allergies, in the process of testing. She had mast cell activation syndrome that was diagnosed in Mar2021, histamines were having intagatlic reaction. She had adjusted her diet, seemed like it was improving, but still feeling it. She had diarrhea, severe cramps, loss of voice lasting a day or two. She was taking Zyrtec four times daily. Carried Epipen. Possible reaction to covid vaccine, but was allergic to egg product and had egg product day of second dosage. Adverse event information provided by her was related to covid vaccine: It was unknown if she was enrolled in a COVID-19 Vaccine Trial. On 12Apr2021, she received 1st dose COVID-19 Vaccine manufactured by Pfizer biontech. On 04May2021, she received 2nd dose COVID-19 Vaccine manufactured by Pfizer biontech. The patient underwent lab tests and procedures which included colonoscopy: unknown result on an unspecified date. The action taken in response to the events for upadacitinib was unknown. The outcome of events mast cell activation syndrome was not recovered/not resolved; outcome of events stomach upset, cramps, gastrointestinal disturbance and chronic diarrhea was recovered/resolved; outcome of food allergy was recovering/resolving; outcome of events vaccination site reaction and loss of voice was unknown. Causality for RINVOQ(UPADACITINIB): The reporter's causality for the events of mast cell activation syndrome, stomach upset, cramping, gastrointestinal disturbance, chronic diarrhea, food allergies/allergic to egg product, vaccination site reaction and loss of voice was not provided. Causality for BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE): The reporter's causality for the events of mast cell activation syndrome, stomach upset, cramping, gastrointestinal disturbance, chronic diarrhea, food allergies/allergic to egg product, vaccination site reaction and loss of voice was possible. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Considering the plausible drug-event temporal association, a contributory role of the suspect product bnt162b2 to the reported events cannot be excluded. Case will be reassessed upon receipt of additional information. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate

Other Meds: ZYRTEC [CETIRIZINE HYDROCHLORIDE]; EPIPEN

Current Illness:

ID: 1711756
Sex: M
Age:
State: IL

Vax Date:
Onset Date:
Rec V Date: 09/18/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot: EK9231
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

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

Symptoms: Often not breathing; Cheeks and throat are little bit puffy; Cheeks and throat are little bit puffy; Headache; Tiredness; Restlessness; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and the patient's concomitant medications were not reported. The patient experienced often not breathing, cheeks and throat are little bit puffy, headache, tiredness, restlessness all on an unspecified date with outcome of unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1711757
Sex: F
Age:
State:

Vax Date: 12/25/2020
Onset Date: 05/01/2021
Rec V Date: 09/18/2021
Hospital:

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

Lab Data: Test Date: 202105; Test Name: COVID TEST; Test Result: Positive ; Comments: she also had covid-19; Test Date: 202105; Test Name: weight; Result Unstructured Data: Test Result:gained; Test Date: 202105; Test Name: White blood count; Result Unstructured Data: Test Result:elevated; Test Name: Body Temperature; Result Unstructured Data: Test Result:Unknown Result; Test Date: 20201124; Test Name: MAGNETIC RESONANCE IMAGING; Result Unstructured Data: Test Result:Unknown Result; Test Name: COVID TEST; Result Unstructured Data: Test Result:Unknown Result

Allergies:

Symptom List: Pain in extremity

Symptoms: she also had covid-19; she also had covid-19; her white blood count was elevated; knee had not 100 percent; gained weight; This is a solicited report based on the information received by Pfizer (Mfr control no: 20K-163-3678612-00). A 62-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via intramuscular on 04May2021 (at the age of 62-year-old) as dose 2, single, and dose 1 intramuscular on 14Apr2021 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous from 25Dec2020 to an unspecified date, at 40 mg for crohn's disease. Medical history included inflammation from 24Nov2020 to an unknown date, the patient had magnetic resonance imaging on the 24Nov2020 that showed inflammation but nothing torn, device physical property issue from an unknown date and unknown if ongoing Detachment of device (Device physical property issue), arthralgia from an unknown date and unknown if ongoing, Painful joints, complication associated with device from an unknown date and unknown if ongoing, joint swelling from an unknown date and unknown if ongoing; Knee swelling, fear of disease from an unknown date and unknown if ongoing, hypersomnia from an unknown date and unknown if ongoing; Sleep excessive, gait disturbance from an unknown date and unknown if ongoing; Stumbling, immunodeficiency from an unknown date and unknown if ongoing, exposure to sars-cov-2 from an unknown date and unknown if ongoing, frequent bowel movements from an unknown date and unknown if ongoing, wrong dosage dispensed from an unknown date and unknown if ongoing, feeling miserable from an unknown date and unknown if ongoing, knee arthropathy from an unknown date and unknown if ongoing, loss of smell from an unknown date and unknown if ongoing, oral intake reduced from an unknown date and unknown if ongoing, mobility decreased from an unknown date and unknown if ongoing, contusion of lower leg from an unknown date and unknown if ongoing, medical device site joint pain from an unknown date and unknown if ongoing, stress from an unknown date and unknown if ongoing, swelling from an unknown date and unknown if ongoing, scar from an unknown date and unknown if ongoing, loss of taste from an unknown date and unknown if ongoing, crohn's disease aggravated from an unknown date and unknown if ongoing, pain legs from an unknown date and unknown if ongoing, headache from an unknown date and unknown if ongoing, nauseous from an unknown date and unknown if ongoing, tenderness from an unknown date and unknown if ongoing, allergy from an unknown date and unknown if ongoing, nerve pain from an unknown date and unknown if ongoing, pain in arm from an unknown date and unknown if ongoing, peripheral neuropathic pain from an unknown date and unknown if ongoing. Concomitant medications included oxycodone taken for an unspecified indication, start and stop date were not reported; tramadol taken for an unspecified indication, start and stop date were not reported; vitamin b complex taken for an unspecified indication, start and stop date were not reported; ondansetron (ZOFRAN) taken for an unspecified indication, start and stop date were not reported; aspirin [acetylsalicylic acid] taken for an unspecified indication, start and stop date were not reported. On an unspecified date in May2021, the patient experienced she also had covid-19, her white blood count was elevated, knee had not 100 percent, gained weight, rotator cuff surgery. The patient underwent lab tests and procedures which included body temperature: unknown result on an unspecified date, magnetic resonance imaging: unknown result on 24Nov2020, sars-cov-2 test: unknown result on an unspecified date, sars-cov-2 test: positive on May2021 she also had covid-19, weight: gained on an unspecified date in May2021, white blood cell count: elevated on May2021. The outcome of the events was unknown. Causality for Humira with she also had covid-19, her white blood count was elevated, knee had not 100 percent, gained weight, rotator cuff surgery per reporter was not reported per Mfr. was no reasonable possibility. The reporter's assessment of the causal relationship of the eventsshe also had covid-19, her white blood count was elevated, knee had not 100 percent, gained weight, rotator cuff surgery with the suspect product BNT162B2 was no reasonable possibility. The lot number for BNT162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine cannot be excluded for the reported events due to temporal relationship.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: OXYCODONE; TRAMADOL; VITAMIN B COMPLEX; ZOFRAN [ONDANSETRON]; ASPIRIN [ACETYLSALICYLIC ACID]

Current Illness:

ID: 1711758
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/18/2021
Hospital:

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

Lab Data: Test Date: 2021; Test Name: temperature; Result Unstructured Data: Test Result:102 degree for 3 days

Allergies:

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

Symptoms: lung got congested; temperature was 102 degrees for 3 days; Rash; This is a spontaneous report received from a contactable consumer or other non-health care professional (patient) via a Pfizer-sponsored program. A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 2 single for covid-19 immunization. (Reason for no lot number: of Covid vaccine: Complainant hung up abruptly/transfer incomplete). Medical history included issue with her heart from 2021 to an unknown date (she went to the doctor because she was still having issues and they noticed she had an issue with her heart. It's been going on about 6 months now). The patient's concomitant medications were not reported. This report is related to a study or programme. Patient previously took first dose of (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection), via an unspecified route of administration on an unspecified date for COVID-19 immunization. On an unspecified date in 2021 after second dose of BNT162B2, the patient's lung got congested, temperature was 102 degrees for 3 days and she also experienced rash. The patient reported that she got both doses of the Covid vaccine, but after the second dose, about 20 minutes later her lung got congested. She went out to her vehicle and used her inhaler and still noticed the problem when she went home that night. She got the regular symptoms and her temperature was 102 degrees for 3 days. Patient had a rash and that all got better, but her lung was still congested. She went to the doctor because she was still having issues and they noticed she had an issue with her heart. It's been going on about 6 months now. Patient went to the emergency room and everything checked out to be fine as far as her heart and lungs. She noticed there was Polyethylene Glycol in the Covid vaccine, and she was wanting to know if this could have caused the issues, if someone else had reported this, or if Pfizer had any recommendations on how to get this all fixed. The patient underwent lab tests and procedures which included body temperature: 102 degree for 3 days on an unspecified date in 2021. Therapeutic measures were taken as a result of lung got congested. The outcome of the event lung got congested was not resolved, and rash was resolving, and outcome of the events temperature was 102 degrees for 3 days was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1711759
Sex: F
Age:
State: CA

Vax Date: 05/01/2021
Onset Date: 05/01/2021
Rec V Date: 09/18/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: the patient on the like 3rd day was knocked out a few seconds and almost brought her to the emergency room; This is a spontaneous report from a contactable consumer (caller is the husband of the patient). This is the second of 2 reports. A 27-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at the beginning of May2021 (Batch/Lot number was not reported) as single dose (at the age of 27) for covid-19 immunisation. Medical history included ongoing genital herpes (reporter does not know when she was diagnosed with genital herpes but states it was many years ago and was before the Pfizer Covid vaccine), caesarean section (she had their 2nd son and had C-sections with both children). There were no concomitant medications. The patient experienced the patient on the like 3rd day was knocked out a few seconds and almost brought her to the emergency room in May2021. It was reported 'she does take anything like one Tylenol in her case she would be fine but she cannot handle strong doses of any medication and had an epidural shot and can't handle over doses of any medication and states that he has no lots, expiry dates, medication names for medications that she cannot handle the doses of including Tylenol to provide'. The outcome was unknown. The lot number for BNT162b2 was not provided and will be requested during follow up

Other Meds:

Current Illness: Genital herpes

ID: 1711760
Sex: F
Age:
State: MN

Vax Date: 06/14/2021
Onset Date: 06/17/2021
Rec V Date: 09/18/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Involuntary movement in right arm and head; Numbness and tingling with severe pain in hands feet and lower legs with joint pain; Numbness and tingling with severe pain in hands feet and lower legs with joint pain; Numbness and tingling with severe pain in hands feet and lower legs with joint pain; Numbness and tingling with severe pain in hands feet and lower legs with joint pain; Numbness and tingling with severe pain in hands feet and lower legs with joint pain; This is a spontaneous report from a contactable consumer (patient). A 13-years-old female non-pregnant patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: Ew0196; Expiry date was unknown), via an unspecified route of administration in the right arm on 14Jun2021 (at the age of 13-years-old) as dose 2, single for COVID-19 immunization at Pharmacy or Drug Store. Medical history was not reported. Patient had known allergies. There were no concomitant medications. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccine within four weeks. The patient had no other medications in two weeks. Historical vaccine included first dose of BNT162B2 (Lot number: Ew0172; Expiry date was unknown), via unspecified route of administration at right arm on 22May2021 (at the age of 13-years-old) as dose 1, single for COVID-19 immunization. On 17Jun2021 at 02:00, after second vaccination, the patient experienced numbness and tingling with severe pain in hands feet and lower legs with joint pain and involuntary movement in right arm and head. Adverse events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, Disability or permanent damage. Therapeutic measures were taken as a result of involuntary movement in right arm and head, numbness and tingling with severe pain in hands feet and lower legs with joint pain. Outcome of the events was not recovered at the time of report. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1711761
Sex: M
Age:
State: FL

Vax Date: 05/02/2021
Onset Date:
Rec V Date: 09/18/2021
Hospital:

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

Lab Data: Test Name: bloodwork; Result Unstructured Data: Test Result:Unknown Results; Test Name: MRI of brain; Result Unstructured Data: Test Result:Unknown Results

Allergies:

Symptom List: Vomiting

Symptoms: Couldn't eat; heavy fatigue; facial tingling and numbness; facial tingling and numbness; This is a spontaneous report from a contactable consumer (patient). A 29-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration administered in left arm at a pharmacy or drug store facility on 02May2021 16:00 (Batch/Lot Number: ER8736) as DOSE 2, SINGLE for covid-19 immunisation. The patient had no covid prior to vaccination and has not been tested for covid post vaccination. The patient had known allergies to dexamethasone. Concomitant medication included famotidine, ibuprofen (DUEXIS). Historical vaccine includes first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on 11Apr2021 (at the age of 29-year-old) for covid-19 immunisation and experienced couldn't eat for 3-5 days after and heavy fatigue. On unspecified date, the patient experienced couldn't eat for 3-5 days, heavy fatigue, and facial tingling and numbness. The events resulted in doctor or other healthcare professional office/clinic visit and was considered serious due to permanent disability. The patient underwent lab tests and procedures which included blood test: unknown results and magnetic resonance imaging (MRI) of brain: unknown results on unspecified date. Therapeutic measures were taken as a result of the events which included Heprin, Niacinamide B6, vitamins, MRI of brain, and bloodwork. The patient had not yet recovered from the events.

Other Meds: DUEXIS

Current Illness:

ID: 1711762
Sex: M
Age:
State: MA

Vax Date: 08/20/2021
Onset Date: 08/20/2021
Rec V Date: 09/18/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 037K20A
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data: Test Date: 20210903; Test Name: Doppler ultrasound; Result Unstructured Data: Test Result:Extensive Clots; Comments: More information available: No; Test Date: 20210903; Test Name: Sonogram; Result Unstructured Data: Test Result:Extensive Clots; Comments: More information available: No

Allergies:

Symptom List: Headache, Limb discomfort, Nasal congestion

Symptoms: Sonogram shows extensive clots throughout superficial greater saphenous veins; Severe lower leg pain; Received third dose of the Covid 19 Vaccine; Received third dose of the Covid 19 Vaccine; This is a spontaneous report received from a contactable physician (patient). A 68-year-old male patient received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot number: EW0198) via an unspecified route of administration on 20Aug2021 (at the age of 68-year-old) as dose 3, single for COVID-19 immunisation. Patient do not have any medical history including any illness at time of vaccination and There were no concomitant medications. Patient do not have any relevant family medical history. Patient did not receive any other vaccines prior to vaccination (within 4 weeks) and patient was healthy prior to vaccination. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot number: EL1284) via an unspecified route of administration on 22Dec2020 (at the age of 67-year-old) as dose 1, single and then dose 2 (Lot number: EL1283) via an unspecified route of administration on 14Jan2021 for COVID-19 immunisation. It was reported that caller states he was calling about the Pfizer Product: Covid 19 Vaccine. States he was calling about a suspected, and highly likely, side effect. States he had the third vaccine about a week ago. One week later he had severe lower leg pain He thought it was musculoskeletal, so he treated it as such. States it did not go away. States he had a sonogram done that shows extensive clots throughout the superficial greater saphenous veins. Caller states his leg pain has been pretty bad the entire time that he has had it. States that hopefully it doesn't move deeper into his system and become life threatening. States he had the sonogram, doppler ultrasound, today. He has to start Eliquis today also and will be on it for a minimum of three months. The patient experienced severe lower leg pain on 27Aug2021, sonogram shows extensive clots throughout superficial greater saphenous veins on 03Sep2021 received third dose of the covid 19 vaccine on 20Aug2021. The patient underwent lab tests and procedures which included ultrasound doppler: extensive clots on 03Sep2021 More information available: No, ultrasound scan: extensive clots on 03Sep2021 More information available: No. He called his primary care provider and told him his symptoms. His primary care ordered him the sonogram. Then caller states he called his cardiologist to discuss treatment. Patient did not visit the emergency room or physician office for the events. Outcome of events severe lower leg pain was not recovered and sonogram shows extensive clots throughout superficial greater saphenous veins was unknown.; Sender's Comments: Based on the information available in the case , a contributory role of the suspect product bnt162b2 to the reported events cannot be excluded. Case will be reassessed upon receipt of additional information. The impact of this report on the benefit/risk profile of the Pfizer drug 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: 1711763
Sex: U
Age:
State: AL

Vax Date: 08/25/2021
Onset Date: 08/25/2021
Rec V Date: 09/18/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: nerves are just all over the place in legs; legs have been throbbing and aching; legs are feeling really heavy; dose 1 was given in Jun2021; dose 2 was given on 25Aug2021; dose 1 was given in Jun2021; dose 2 was given on 25Aug2021; This is a spontaneous report from a contactable consumer (patient). A 60-year-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the left arm, on 25Aug2021 (Batch/lot number: FC3184, Expiration date unknown), at age 60 years old, as dose 2, single, for COVID-19 immunisation. Relevant medical history includes being paraplegic on a wheelchair from an unknown date and ongoing. Concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the left arm, in Jun2021 (Bath/lot number: EW0150), at age 60 years old, as dose 1, single, for COVID-19 immunization and had some really bad side effects. The patient did not receive any other vaccines within 2 weeks prior to the first BNT162B2 shot. It was reported that the patient received dose 1 in Jun2021. The patient was supposed to receive dose 2 on 21Jul2021 but did not receive it. The patient received dose 2 on 25Aug2021. On 26Aug2021, 1 day after dose 2, the patient's legs have been throbbing and aching, nerves are just all over the place in legs are feeling really heavy. So, the patient went to the ER on 26Aug2021 and they gave the patient an unspecified shot to calm the nerves down. The patient reported that it has been over a week and the patient was still having problems. The patient does not understand why the hurting does not stop. The patient states that it has gotten better but still hurts, the physician said it would last 4-5 days, but it has been past 7 days already. The outcome of the events was not resolved. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness: Paraplegic; Wheelchair user

ID: 1711764
Sex: F
Age:
State: ME

Vax Date: 09/03/2021
Onset Date: 09/05/2021
Rec V Date: 09/18/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025j20-2A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data: Test Name: blood pressure; Result Unstructured Data: Test Result:High

Allergies:

Symptom List: Injection site swelling, Limb discomfort

Symptoms: suicidal thougths; Severe depression; tgen my c-ptsd got so severe; This is a spontaneous report from a Non-contactable consumer (patient). A 34-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: unknown) via an unspecified route of administration (Age at time of vaccination: 34) on 03Sep2021, 03.45 PM in left arm as dose 1, single dose for COVID-19 immunisation. Patient medical history reported as C-pstd, migraines, concussions, fibromyalgia, pmdd, endometriosis, diabetes type 2, high blood pressure from an unknown start and stop dates. Patient's known allergies were too many to list. Concomitant medication reported as Vitamin B12, folic acid, fluvoxamine, buisperone. No other vaccine administered within four weeks. COVID prior vaccination was reported as no and COVID test post vaccination reported as no. On 05Sep2021 03:30 AM, patient experienced Severe depression and suicidal thoughts increase and tgen c-ptsd got so severe. On unspecified date patient underwent lab test and procedure included Blood pressure measurement: high. Treatment was not taken. The clinical outcome of all events were unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds: VITAMIN B12 [CYANOCOBALAMIN]; FOLIC ACID; FLUVOXAMINE; BUSPIRONE

Current Illness:

ID: 1711765
Sex: M
Age:
State:

Vax Date: 08/26/2021
Onset Date: 08/26/2021
Rec V Date: 09/18/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Weakness; Low grade fever; Itch throat; trying to find out so that he doesn't know infect anybody else the COVID; got symptoms of COVID; This is a spontaneous report received from a contactable consumer (patient's wife) reported that a male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number and Expiry Date: Unknown), via an unspecified route of administration on 26Aug2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient was calling on behalf of her husband who got the first dose of the Pfizer COVID-19 Vaccine last 26Aug2021 and after getting it, the husband got symptoms of COVID which was weakness, low grade fever and itch throat actually he was asking if, was it possible that these are the side effects of vaccine. The patient's wife did not know, he was not in here with me, she was trying to find out so that he doesn't know infect anybody else the COVID (Further clarification unknown). Reporter seriousness for all events were unspecified. The outcome of the events was unknown. This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.

Other Meds:

Current Illness:

ID: 1711766
Sex: M
Age:
State: MD

Vax Date: 08/22/2021
Onset Date: 08/22/2021
Rec V Date: 09/18/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 037K20A
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Hot flush, Myalgia, Nausea, Tension headache

Symptoms: Fainted, Could not get up for 30 minutes; Tunnel vision; Clammy Skin; Headache; This is a spontaneous report from a contactable Consumer or other non-HCP (patient). A 12-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EW0164), dose 1 via an unspecified route of administration, administered in Arm Left on 22Aug2021 at 16:00 (at the age of 12-year-old) as DOSE 1, SINGLE for covid-19 immunisation at Pharmacy or Drug Store. Medical history was none. The patient had no COVID prior vaccination. Known allergies was reported as unknown. There were no concomitant medications. The patient had no other vaccine in four weeks. The patient had no other medications in two weeks. The patient had not been COVID tested post vaccination. On 22Aug2021 at 04:15 AM, the patient experienced fainted, tunnel vision, clammy skin, headache and could not get up for 30 minutes. No treatment was received to treat the events. The patient outcome of the events was Unknown at the time of this report. Follow-Up (07Sep2021): Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am