VAERS 2021 Database www.vaers.hhs.gov

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

Total Manufacturer
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: 1657863
Sex: F
Age:
State:

Vax Date: 04/01/2021
Onset Date: 04/01/2021
Rec V Date: 08/31/2021
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: appeared to look like MRSA- not the rest of the reaction; Skin Reaction; Red bumps all over my face and neck; Itchy; Urticaria like / hives on my neck; There were a lot of flat red and purple colorations on my face; Impetigo; Hyperpigmentation on my forehead; Microcirc red dots all over my face like inflammation and blood vessels; They are super annoying it's like having blood clots on my skin; This is a spontaneous report from a non-contactable nurse (patient). A 30-year-old female non-pregnant patient received bnt162b2, second single dose via an unspecified route of administration, administered in arm left in Apr2021 (Batch/Lot number was not reported) for covid-19 immunisation at age of 30-year-old. Medical history included allergy to amoxicillin; clavulanic acid (AUGMENTIN), fentanyl, duck feathers and hay. The patient previously received first single dose of bnt162b2 at left arm in Mar2021 at age of 30-year-old. The patient's concomitant medications were not reported. 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. The patient experienced skin reaction- red bumps all over her face and neck, itchy, then urticaria like / hives on neck. The patient went to urgent care, got doxycycline (doxy) - treated some of the red lesions which appeared to look like MRSA- not the rest of the reaction. there were a lot of flat red and purple colorations on face. She looked polka dotted. After the doxy, the bumpy lesions and the crusted ones went away. The patient never had any yellow crusting so it was not typical that these be impetigo, nor does impetigo come with hyperpigment polka dots. The hives and wheals went away after taking benadryl. but the itching lasted 2 days. the hyperpigmentation on forehead was still here now in Aug2021. The patient nor hyperpigment spots just randomely pop up like that. Some of them were straight uppurple. Ive have since this occurred, what looked to be microcirc red dots all over my face like inflammation and blood vessels. They are super annoying it's like having blood clots on skin. Events onset in Apr2021. The event resulted to doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient received doxycycline, Benadryl as treatment for the events. Outcome of the events was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Staphylococcal infection, skin reaction,rash papular, Pruritus, Urticaria, Skin discolouration, Impetigo, Skin hyperpigmentation, Inflammation and thrombosis cannot be totally excluded.This case will be reassessed once additional information is available.The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Other Meds:

Current Illness:

ID: 1657864
Sex: U
Age:
State: MN

Vax Date: 04/25/2021
Onset Date: 06/10/2021
Rec V Date: 08/31/2021
Hospital:

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

Lab Data: Test Date: 20210610; Test Name: ANA positive; Result Unstructured Data: Test Result:1:1280; Test Date: 20210610; Test Name: rheumatoid and autoimmune diseases; Test Result: Negative; Test Date: 20210607; Test Name: PCR; Test Result: Negative; Comments: Nasal Swab.

Allergies:

Symptom List: Anxiety, Dyspnoea

Symptoms: paresthesia of face and arms; numbness and pain of face, arms, legs, and extremities; numbness and pain of face, arms, legs, and extremities; numbness and pain of face, arms, legs, and extremities; Back, Muscle, and Joint pain; Back, Muscle, and Joint pain; Back, Muscle, and Joint pain; This is a spontaneous report from a contactable consumer (patient). An unspecified gender 44-year-old patient received the second dose of BNT162B2 (PFIZER COVID 19) via an unspecified route of administration on the left arm on 25Apr2021 at 15:30 (Batch/Lot Number: ER8735) at the age of 44-year-old as single dose for COVID-19 immunization. Known allergies included ragweed allergy, slight allergy to bananas, cat/dog allergy, alternaria allergy and birch allergy. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. The patient didn't receive other vaccines within 4 weeks prior to the COVID vaccine. The patient didn't received other medications within 2 weeks of vaccination. The patient previously received the first dose of BNT162B2 via an unspecified route of administration on the left arm on 04Apr2021 at 03:30 PM (Batch/Lot Number: ER8737) at the age of 44-year-old as single dose of COVID-19 immunization. On 10Jun2021 at 17:00, the patient experienced initial paresthesia of face and arms, eventual numbness and pain of face, arms, legs, and extremities. Back, Muscle, and Joint pain. ANA positive, 1:1280. Negative for all rheumatoid and autoimmune diseases thus far. Still working with Neurology, no large muscle or nerve issues, small fiber skin biopsy scheduled this week. The patient performed PCR (Nasal Swab) on 07Jun2021 and result was negative. The events resulted in emergency room visit and physician office visit. No treatment was not received. The events were not resulted in hospitalization prolonged. The outcome of events was not recovered.

Other Meds:

Current Illness:

ID: 1657865
Sex: F
Age:
State: NJ

Vax Date: 04/08/2021
Onset Date: 04/01/2021
Rec V Date: 08/31/2021
Hospital:

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

Lab Data: Test Date: 2021; Test Name: Cholesterol; Result Unstructured Data: Test Result: Unknown; Test Date: 2021; Test Name: Blood Work; Result Unstructured Data: Test Result: Unknown; Test Date: 2021; Test Name: Gout; Result Unstructured Data: Test Result: no uric acid; Comments: It's not gout she has no uric acid; Test Date: 2021; Test Name: Heart test; Result Unstructured Data: Test Result: Good; Test Date: 2021; Test Name: Liver Function; Result Unstructured Data: Test Result: Good; Test Date: 2021; Test Name: Lyme's; Result Unstructured Data: Test Result: showing negative; Test Date: 2021; Test Name: Cancer; Result Unstructured Data: Test Result: No; Test Date: 2021; Test Name: Kidney Function; Result Unstructured Data: Test Result: Good.

Allergies:

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

Symptoms: severe swollen feet; wart; sinus infection; she's had back pain and chronic pain, things happening in upper body, and it settled in the feet; she's had back pain and chronic pain, things happening in upper body, and it settled in the feet; ears shooting in pain; This is a spontaneous report from a Pfizer Sponsored Marketing Program via Regulatory Authority, contactable consumer (patient). A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 08Apr2021 (Batch/Lot Number: EP7533; Expiration Date: 31Jul2021) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included Lyme's disease and breast cancer. A patient with a medical history of Lyme's disease and cancer who started taking Tamoxifen during the early months of spring 2021 (unable to provide an exact date). Medical Conditions: She got rid of breast cancer in the left breast last May, all of this was before the covid vaccine, her Lyme's disease was diagnosed 8 years ago. She had Lyme's for over 5 years before it was diagnosed and caught, she was misdiagnosed. Concomitant medications included anastrozole (ARIMIDEX) taken for an unspecified indication from Jul2021 to the end of Jul2021; tamoxifen taken for an unspecified indication from 2021 to an unspecified stop date. She discontinued the Arimidex generic called Anastrozole 1mg once a day at night. She discontinued Anastrozole at the end of Jul2021. When queried for the Lot number, caller states that she needs to get the bottle, during this she states that it be easier to walk on her butt right now than her feet, maybe that would help her abs, she is disgruntled, she lives at a lake and wanted to be swimming like she does seasonally and that she is not doing. Anastrozole is dispensed in a manufacture bottle, 1mg tablet, Lot 110796 Expiry DEC2022 NDC... caller states that she needs to focus on it, her eyes are screwing up it is 0093-7536-56 Manufacture in Israel by Teva. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 16MAR2021 (Lot EN6206) for covid-19 immunisation. Caller received the first dose of the Pfizer Covid-19 vaccine on 16MAR2021 and started having complaints of body aches, chills, and fever. Joint pain had been months, she had always had joint pain because of Lyme's Disease, but this was more out of ordinary last month. Inclusively with the first vaccine she had achiness, joint pain in neck and shoulders that shifted down the body, mild fever, and sinus infection. Her symptoms occurred for the 3-4 days after the first dose. After second dose, the patient experienced wart in Jun2021, sinus infection, back pain and chronic pain, things happening in upper body, and it settled in the feet, ears shooting in pain all in Apr2021, severe swollen feet in Jul2021. Caller received the second dose of the Pfizer Covid-19 vaccine on 08APR2021 and four days afterwards had complaints of a sinus infection (In Apr2021) and started taking a Z-pack on day five or six after receiving the second dose. Caller now has complaints of severe swollen feet (Jul2021) and states that she has consulted with her HCP about it and has had blood work done and a diagnosis of gout has been eliminated. Caller stated that its unexplainable, she has received the shots, was is on board with the process and was pro vaccine, even she was pushing at people to get the vaccine, people said that they didn't want the government telling them what to do but people wear seat belts. Now with the delta variant and it spiking in so many places, she was just not willing to be one of those people. She was an open book, she had an infectious disease doctor and with her Lyme's disease he was the first to crack it, he got to the end result. She is 58 and has been through menopause, other doctors would tell her what she was experiencing was menopause, but she knew that there was something serious going on. She did not get covid. She is a massage therapist by trade. She recalls getting the second dose in a 3 weeks span. She was due on the 7Apr2021 but went on the 8Apr2021 at 8AM. Her card was a non laminated sheet but she will get it laminated since it seems like this was becoming a standard protocol to carry the card. She got the vaccine at withheld by the withheld, they did kick ass job. She thought she didn't have a reaction (sinus infection), but after the first 4 days, which was a breeze she thought, on the 4th or 5th days she had the sinus infection come out the blue, with her eye balls swelled, ears shooting in pain and even her neck on the right side was swelling. She got both injection son the right side. Swollen feet just started in the midst of Jul2021, it was way after the second dose, she's had back pain and chronic pain, things happening in upper body, and it settled in the feet. At the moment it is ongoing and getting worse. The swelling started in the last 2 weeks. Initially, the pain was there in the feet, but the swelling was not there. Investigation: She did 4 vials of Blood work on Wednesday and got results on Saturday, they checked Liver and kidney function, cholesterol and gout. It's not gout she has no uric acid. The Lyme's was showing negative, it was low levels not big enough to be put as a red flag. The kidney and liver is good, heart is good, no cancer. Just before she had growth on her head, it wasn't on face, it was ugly, it was a wart, she never had a wart before, it showed up Jun2021, she saw Doctor. withheld but didn't think to say anything though, she thought it was a bug bite, it grew really fast she discovered it big on 23Jul2021 or in that time frame. Her feet were killing her but she stayed in the ocean, her feet were killing her, but she had a beach hat on. They removed the wart on 05Aug2021 by a dermatologist, it was cut off and sent to a lab. The outcome of severe swollen feet, back pain and chronic pain, things happening in upper body, and it settled in the feet was not recovered, outcome of other events was unknown. Information on the lot/batch number has been requested.

Other Meds: Arimidex; Tamoxifen

Current Illness:

ID: 1657866
Sex: F
Age:
State: CT

Vax Date: 06/14/2021
Onset Date: 06/14/2021
Rec V Date: 08/31/2021
Hospital: Y

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

Lab Data:

Allergies:

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: Allergic reaction from the vaccine; Fever; It was very hard for me to breath; This is a spontaneous report received from a contactable consumer(patient). A 28-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 14Jun2021 (Lot Number: ER8736) (at age of 28-year-old) in Left upper arm as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant drugs was not reported. There was no prior vaccination (within 4 weeks). The patient previously took the first dose of BNT162B2 on 07May2021 (at age of 28-year-old) (Lot: EWO164, not sure if this O or 0) for COVID-19 Immunization. The patient experienced allergic reaction from the vaccine (hypersensitivity) (hospitalization), fever (pyrexia) (hospitalization), it was very hard for me to breath (dyspnoea) (hospitalization), all on 14Jun2021. Consumer stated, "I had my first dose of Pfizer vaccine 07May2021 and my second one is on 14Jun2021 and on 14June night, I started to have like a fever and it was very hard for me to breath. So, I waited to like a few hours I might feel little bit better but my condition got worse. So, I decided to go to an emergency room. On June 15, early morning and as a resort of that, they gave like a medicine there they managed my breathing problem and my fever and so I went home. And as a resort of that I have a medical bill of # dollars. So, I get energy care and the following morning like 7 they have prescribed me a medicine for allergy, it is like an allergic reaction so like for the allergic reaction that I have from the vaccine, So, after administration of medicine for hour my fever brought down I was able to somehow breathe and everything is manageable at my end." When clarified, consumer stated, "Basically, I was able to breathe a little, what they did in emergency room they just managed me in order for me to breath and all that and then they released me but I still have some fever but I was able to breath. So, it was early morning it was like 3 o'clock in the morning so there was no urgent care or any facility that I can go apart from emergency department at that hour. So, I was able to breathe. So, upon discharge I did take the medical services of an urgent care like 7 o'clock in the morning and they are the ones that prescribed me the medicine for allergy which I bought but that is all started out." Treatment: Consumer stated, "Saline nasal spray, Albuterol Sulfate, its inhalation aerosol inhaler 90 mcg and other one is antihistamine and other one is just Tylenol." The outcome of the events was resolved on 15Jun2021. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1657867
Sex: U
Age:
State: FL

Vax Date: 07/18/2021
Onset Date: 07/18/2021
Rec V Date: 08/31/2021
Hospital:

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

Lab Data: Test Name: Blood pressure; Result Unstructured Data: Test Result:137/76; Test Name: Temperature; Result Unstructured Data: Test Result:98 Fahrenheit; Test Name: CT head Brain W/O contrast; Result Unstructured Data: Test Result:Results awaiting; Test Name: Culture Urine -Random; Result Unstructured Data: Test Result:Unknown; Test Name: CBC with diierential; Result Unstructured Data: Test Result:Unknown; Test Name: Pulse; Result Unstructured Data: Test Result:68; Test Name: MRI; Result Unstructured Data: Test Result:Unknown; Test Name: Basic Metabolic Panel; Result Unstructured Data: Test Result:Unknown; Test Name: Oxygen Saturation; Test Result: 99 %; Test Name: Respiration; Result Unstructured Data: Test Result:18; Test Name: POCT HCG Urine; Result Unstructured Data: Test Result:Unknown; Test Name: POCT Urine Dipstick; Result Unstructured Data: Test Result:Unknown; Test Name: Urinalysis; Result Unstructured Data: Test Result:Unknown

Allergies:

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

Symptoms: vomiting; weakness; SOB; Palpitations; headache; body pain; high blood pressure; nausea; heart beat; pain heart; couldnt sleep all night; This is a spontaneous report from a contactable consumer (patient). A 42-year-old patient of an unspecified gender received the first dose of bnt162b2 (BNT162B2), via an unspecified route of administration at the age of 42-year-old on 18Jul2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included allergy to penicillins, cat dander, dog dander. The patient's concomitant medications were not reported. The patient received first dose of Pfizer vaccine on 18Jul2021. The patient was really disappointed the way vaccine was working. A lot of side effects from vaccine without knowing exactly side effects. The patient decided to take the vaccine on 18Jul2021 and was completely fine before the vaccine. Everything goes wrong that night 18Jul2021, the patient couldn't sleep at night and thought it was normal reaction. But on 19Jul2021 everything got worse and the patient going to emergency room because the symptoms was not normal such as headache, body pains, high blood pressure, nausea, heartbeat abnormal, pain heart. The doctor said it was normal reaction to the vaccine and said if the patient feels same after 5 days, they need to check. But all symptoms got worse in fact, the patient started vomiting with all symptoms that no was going away on 01Aug2021. The patient was back to the hospital again with headache, nausea, vomiting, high blood pressure, weakness. The patient received some medication that day and feel better. But the next day the symptoms no was going away, the patient had a lot of headache, nausea, high blood pressure and pain heart. The patient was waiting for MRI test of head. The patient was not able to work because got side effects from vaccine Pfizer. The patient also experienced SOB (dyspnoea) and palpitations on 29Jul2021. The events were caused patient Emergency Room Visit. It is reported the patient under treatment with Acetaminophen (Tylenol), Metoclopramide HCL (REGLAN), sodium Chloride 0.9% 1000ml Bolus for all events. The patient underwent lab tests and procedures which included blood pressure measurement: 137/76, body temperature increased: 98 fahrenheit, CT head Brain W/O contrast: results awaiting, Culture Urine -Random: unknown, CBC with diierential: unknown, Pulse: 68, MRI: unknown, Basic Metabolic Panel: unknown, oxygen saturation: 99 %, Respiration: 18, POCT HCG Urine: unknown, POCT Urine Dipstick: unknown, Urinalysis: unknown, all on an unknown date. The outcome of the all events were not recovered.

Other Meds:

Current Illness:

ID: 1657868
Sex: F
Age:
State: IL

Vax Date:
Onset Date: 08/09/2021
Rec V Date: 08/31/2021
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 Name: Covid-19; Test Result: Positive

Allergies:

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

Symptoms: I had the shot of Pfizer (Pfizer Covid-19 Vaccine) and I have Covid; I had the shot of Pfizer (Pfizer Covid-19 Vaccine) and I have Covid; This is a spontaneous report from a contactable consumer(patient). A 50 years old female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 02Feb2021(vaccination at age of 49 years old) (Batch/Lot number was not reported) as single dose, 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. Anatomical site of vaccine administration reported as in the arms, in the upper arms, both arms, on in the right and then one in the left upper arm. Medical history included Hiatal hernia, gastrooesophageal reflux disease, Fibromyalgia, Covid. Concomitant medication(s) included duloxetine hydrochloride (CYMBALTA), omeprazole and duloxetine for Fibromyalgia, taken for an unspecified indication, start and stop date were not reported. The patient underwent lab tests and procedures which included covid-19: positive on unknown date. Consumer stated "I had the shot of Pfizer (Pfizer Covid-19 Vaccine) and I have Covid. And this is the second time that I have had Covid. This time it has been the worst. I guess, the weird thing was that I got it twice and I don't know if there is something like they should do, like check me or to see if I should have like to check me or to see if I should have like, if I would have scared if I would have to get it again. I just think now that there is something that you guys needed to know because like I work in a hospital in withheld and I am like the first person who has gotten sick, it is like, my whole hospital has like turned away freaky now." (Further clarification unknown), I am a Certified Nursing aide, I would be willing to like your study or something to figure out why, I got sick. I don't want to get sick again, it is weird." Consumer stated, "My first symptoms started. I had a headache on Monday, the 09Aug2021. They put me on withheld what they call it, which is Azithromycin Tablet that is what I am on now." Outcome for events was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds: CYMBALTA; OMEPRAZOLE; DULOXETINE

Current Illness:

ID: 1657869
Sex: U
Age:
State: TX

Vax Date: 03/28/2021
Onset Date:
Rec V Date: 08/31/2021
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-19 Virus test; Test Result: Positive

Allergies:

Symptom List: Pyrexia, White blood cell count decreased

Symptoms: They have 7 or 8 people positive for covid at this time; all of them have received the vaccine and 6 people out of 7 or 8 that are infected have the Pfizer BioNTech Coivid-19 vaccine; They have 7 or 8 people positive for covid at this time; all of them have received the vaccine and 6 people out of 7 or 8 that are infected have the Pfizer BioNTech Covid19 vaccine; This is a spontaneous report from contactable Nurse. This Nurse reported similar events for 6 patients. This report is for 5th of 6 patient. A 64-year-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration on 28Mar2021 (Lot Number: ER8734; Expiration Date: 31Jul2021) at the age of 64-year-old as dose number unknown, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced positive for covid at this time; all of them have received the vaccine and 6 people out of 7 or 8 that are infected have the Pfizer BioNTech Covid19 vaccine. The patient underwent lab tests and procedures which included COVID-19 Virus test: positive on unknown date. The outcome of events was unknown. As of 19Aug2021, product Quality complaint Group provided conclusion: The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE INJECTABLE lot ER8734 was investigated. The investigation included reviewing manufacturing and packaging batch records, deviation investigations, analytical release test results, and an analysis of complaint history for the reported lot. The final scope was determined to be the reported finished goods lot ER8734, fill lot EP8686, and the formulated drug product lot EP8573. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality. No root cause or CAPA were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101058200 same product and event, different patients

Other Meds:

Current Illness:

ID: 1657870
Sex: F
Age:
State: LA

Vax Date: 07/19/2021
Onset Date: 08/06/2021
Rec V Date: 08/31/2021
Hospital: Y

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

Lab Data: Test Name: LP; Test Result: Negative ; Comments: negative LP.; Test Name: MS evaluation; Test Result: Negative ; Comments: MS evaluation negative

Allergies:

Symptom List: Pharyngeal swelling

Symptoms: hemiparesis; acute disseminated encephalomyelitis; Has multiple brain demyelinating lesions; psychiatric problems; This is a spontaneous report from a contactable physician. A 61-year-old female patient (not pregnant) received an unknown dose of BNT162B2 via intramuscular on 19Jul2021 (Lot Number: EW0191) at the age of 61-year-old as single dose for COVID-19 immunization. Medical history included HTN and depression. Known allergy included PCN, flagyl and azithromycin. The patient didn't receive other vaccine in four week. The patient had received other medications in two weeks. The patient didn't COVID prior vaccination. The patient didn't perform COVID test post vaccination. The patient previously received Azithromycin, Flagyl and experienced allergy. On 06Aug2021, patient developed hemiparesis and psychiatric problems. She was hospitalized and diagnosed with acute disseminated encephalomyelitis. Has had 2 neurologic consultations. Has multiple brain demyelinating lesions.MS evaluation negative, negative LP. The events resulted in emergency room visit and physician office visit. The patient was hospitalized for three days. Treatment included IV steroids. The outcome of events was not recovered.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Hemiparesis, Psychiatric disorder NOS, Acute disseminated encephalomyelitis and Demyelination cannot be totally 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: 1657871
Sex: F
Age:
State: PA

Vax Date: 05/01/2021
Onset Date: 05/01/2021
Rec V Date: 08/31/2021
Hospital: Y

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: 2-3 weeks following COVID-19 vaccination the patient suffered a ruptured ovarian cyst. This was followed by a rash and intense pain. The patient is now unable to walk and in a rehab. Not clear if thes; 2-3 weeks following COVID-19 vaccination the patient suffered a ruptured ovarian cyst. This was followed by a rash and intense pain. The patient is now unable to walk and in a rehab. Not clear if thes; 2-3 weeks following COVID-19 vaccination the patient suffered a ruptured ovarian cyst. This was followed by a rash and intense pain. The patient is now unable to walk and in a rehab. Not clear if thes; 2-3 weeks following COVID-19 vaccination the patient suffered a ruptured ovarian cyst. This was followed by a rash and intense pain. The patient is now unable to walk and in a rehab. Not clear if thes; This is a spontaneous report from a contactable consumer. An adult female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular in May2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included coeliac disease (known allergies: Celiac disease-related issues). The patient's concomitant medications were not reported. It was unknown if the patient receive any other vaccines within 4 weeks prior to the COVID vaccine and any other medications the patient received within 2 weeks of vaccination.Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, it was unknown if the patient had been tested for COVID-19. In May2021, 2-3 weeks following COVID-19 vaccination the patient suffered a ruptured ovarian cyst. This was followed by a rash and intense pain. The patient is now unable to walk and in a rehab. The events resulted in emergency room/department or urgent care, hospitalization, disability or permanent damage. The outcome of the events was recovering. Therapeutic measures were taken as a result of the events. The lot number for [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1657872
Sex: F
Age:
State: GA

Vax Date: 03/18/2021
Onset Date: 04/15/2021
Rec V Date: 08/31/2021
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: 20210601; Test Name: calcium; Result Unstructured Data: Test Result:10.2 mg/dl mg/dl; Test Date: 20210601; Test Name: cholesterol; Result Unstructured Data: Test Result:217 mg/dl mg/dl; Test Date: 20210601; Test Name: creatinine; Result Unstructured Data: Test Result:1.01 mg/dl mg/dl; Test Date: 20210601; Test Name: glucose; Result Unstructured Data: Test Result:103 mg/dl mg/dl; Test Date: 20210714; Test Name: BONE MINERAL DENSITY; Result Unstructured Data: Test Result:0.869 g/cm2; Comments: Left hip; Test Date: 20210714; Test Name: BONE MINERAL DENSITY; Result Unstructured Data: Test Result:0.552 g/cm2; Comments: Left femoral neck; Test Date: 20210714; Test Name: BONE MINERAL DENSITY; Result Unstructured Data: Test Result:0.874 g/cm2; Comments: Spine (L1-13); Test Date: 20210714; Test Name: DXA bone density; Result Unstructured Data: Test Result:Osteopenia in the lumbar spine and osteoporosis in; Comments: Osteopenia in the lumbar spine, T score is -1.3 and osteoporosis in the left femoral neck, the T score is -2.7 were detected. Spine (L1-13) BMD: 0.874 g/cm2, Left Hip Total BMD: 0.869 g/cm2, Left femoral neck BMD: 0.552 g/cm2; Test Date: 20210415; Test Name: ECG; Result Unstructured Data: Test Result:Abnormal ECG; Comments: Moderate voltage criteria for left ventricular hypertrophy (LVH), may be normal variant, Normal sinus rhythm, Non specific T wave abnormality; Test Date: 20210601; Test Name: GFR MDRD Af Amer; Result Unstructured Data: Test Result:68 ml/min/1.73m2; Test Date: 20210601; Test Name: GFR MDRD Non Af Amer; Result Unstructured Data: Test Result:58 ml/min/1.73m2; Test Date: 20210601; Test Name: HDL; Result Unstructured Data: Test Result:52 mg/dl mg/dl; Test Date: 20210601; Test Name: ldl; Result Unstructured Data: Test Result:144 mg/dl; Test Date: 20210601; Test Name: Non-HDL cholesterol (LDL + VLDL); Test Result: 165 mg/dl; Test Date: 20210714; Test Name: osteopenia; Result Unstructured Data: Test Result:1.3; Comments: osteopenia in lumbar spine, the T score is 1.3; Test Date: 20210714; Test Name: osteoporosis; Result Unstructured Data: Test Result:2.7; Comments: osteoporosis in the left femoral neck, the T score is 2.7

Allergies:

Symptom List: Diarrhoea, Nasal congestion

Symptoms: osteoporosis; reduced kidney function; left ventricular hypertrophy; This is a spontaneous report from a contactable consumer (patient). A 65-years-old female patient received the second dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine via an unspecified route of administration on 18Mar2021, at 65 years of age, (Batch/Lot Number: EP7534) as single dose for COVID-19 immunization. Medical history included headache from 04Apr2021 and ongoing, for which a MRI-Brain was performed on 30Jul2021 follow up with Dr is scheduled on 31Aug2021 and family history of stroke in Aug2009. Historical vaccine included the first dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine Lot# EL9266) administered on 25Feb2021, after which her hair has been shedding and falling out. The patient didn't receive any other vaccination within the previous 4 weeks. Concomitant medications included telmisartan 40 mg tablets by mouth; ubidecarenone (CO Q-10) 10 mg capsule; amlodipine besilate 10 mg tablet by mouth; omeprazole 20 mg capsule by mouth; fluticasone propionate 50 mcg/actuation nasal spray, acetylsalicylic acid (ASPIRIN) 81 mg by mouth and omega-3 fatty acids-fish oil 360-1,200 mg cap, all taken for an unspecified indication since an unknown date and benzalkonium chloride;sodium chloride (ALIVE) tablet taken for an unknown indication since 30Jun2020. On 15Apr2021 an abnormal ECG was detected: Moderate voltage criteria for left ventricular hypertrophy (LVH), may be normal variant, Normal sinus rhythm, Non specific T wave abnormality. Lipid panel performed on 01Jun2021 showed high LDL and a high cholesterol. A suggestion to correct it with nutritional and exercise was made. Chemistry also showed a reduced kidney function, assessed as medically significant. Moreover the patient experienced osteoporosis, assessed as medically significant. It was diagnosed through a DXA Bone density exam performed on 14Jul2021 9:14 AM for asymptomatic menopausal state. Lumbar and hip (proximal femur) bone densitometry was performed using the Hologic Bone Densitometry Unit. Osteopenia in the lumbar spine, T score is -1.3 and osteoporosis in the left femoral neck, the T score is -2.7 were detected. Based on FRAX assessment the 10 year probability of major osteoporotic fracture is 14%. Ten year risk for hip fracture is 3.4%. The patient underwent lab tests and procedures which included Spine (L1-13) BMD: 0.874 g/cm2 (Young Adult comparison, T score: -1.3, Age-Matched comparison, Z score: 0.5) - L4 was omitted as it was falsely elevated due to sclerotic and degenerative change. Left Hip Total BMD: 0.869 g/cm2 (Young Adult comparison, T score: -0.6, Age-Matched comparison, Z score: 0.7), Left femoral neck BMD: 0.552 g/cm2 (Young Adult comparison, T score: -2.7, Age-Matched comparison, Z score:-1.1). Relevant lab test collected on 01Jun2021 also included Glucose 103 mg/dl (standard range- 65-99 mg/dl) (for someone without known diabetes, a glucose value between 100 and 125 mg/dl is consistent with prediabetes and should be confirmed with a follow up test); Creatinine 1.01 mg/dl (standard range 0.50- 0.99 mg/dl), GFR MDRD Non Af Amer- 58 ml/min/1.73m2; GFR MDRD Af Amer- 68 ml/min/1.73m2 (standard range > or= 60 ml/min/1.73m2), calcium- 10.2 mg/dl (standard range 8.6-10.4 mg/dl), cholesterol, total- 217 mg/dl (standard range < 200 mg/dl), HDL- 52 mg/dl (standard range > or= 50 mg/dl ), LDL calculated- 144 mg/dl (Reference range < 100 for primary prevention), Non-HDL Chol (LDL + VLDL) 165 mg/dl (calc) (standard range < 130 mg/dl (calc)). At the time of the report the events outcome was unknown. Follow-up attempts are completed. No further information is expected.

Other Meds: TELMISARTAN; CO Q-10; AMLODIPINE BESILATE; OMEPRAZOLE; FLUTICASONE PROPIONATE; ASPIRIN [ACETYLSALICYLIC ACID]; FISH OIL;OMEGA-3 FATTY ACIDS; ALIVE

Current Illness: Headache (MRI Brain 30Jul2021 follow up with Dr 31Aug2021)

ID: 1657873
Sex: F
Age:
State: NJ

Vax Date: 03/18/2021
Onset Date: 08/15/2021
Rec V Date: 08/31/2021
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: 20210816; Test Name: COVID-19 test; Test Result: Positive

Allergies:

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

Symptoms: Tested positive to covid; Tested positive to covid; This is a spontaneous report from a contactable consumer (patient herself). A non-pregnant 55-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), dose 1 via an unspecified route of administration, administered in left arm, on 25Feb2021 (Batch/Lot Number: EL3247) as DOSE 1, SINGLE, and dose 2 via an unspecified route of administration, administered in left arm, on 18Mar2021 (Batch/Lot Number: EL3247) as DOSE 2, SINGLE, for COVID-19 immunization, Age at Vaccination: 55 years (as reported). Relevant medical history includes high blood pressure. Prior to vaccination, the patient was not diagnosed with COVID-19. Patient had no known allergies. Concomitant medications included losartan and vitamins nos (DAILY VITAMINS), both taken for an unspecified indication, start and stop date were not reported. On 15Aug2021, patient had runny nose, cough, headache, sore throat, chills without fever, watery eyes, heavy eyes. Then on 16Aug2021, patient tested positive to COVID. No treatment was received for the events. Since the vaccination, the patient had been tested for COVID-19 via nasal swab on 16Aug2021 with result positive. Facility where the most recent COVID-19 vaccine was administered was at a workplace clinic. The outcome of the events was not recovered.

Other Meds: LOSARTAN; DAILY VITAMINS

Current Illness:

ID: 1657874
Sex: F
Age:
State: KY

Vax Date: 03/23/2021
Onset Date: 03/24/2021
Rec V Date: 08/31/2021
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: 20210717; Test Name: covid; Test Result: Negative ; Comments: Nasal Swab

Allergies:

Symptom List: Rash, Urticaria

Symptoms: continuous rash; itching; burning since second vaccine; allergy to chemical; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient (not pregnant) received the second dose of BNT162B2 via an unspecified route of administration on the left arm on 23Mar2021 at 13:00 (Lot Number: Unknown) at the age of 64-year-old as single dose for COVID-19 immunization. Medical history included hypothyroidism, PTSD, depression, latex allergy and penicillin allergy. The patient was not COVID prior vaccination. The patient performed Covid test (Nasal Swab) post vaccination on 17Jul2021 and result was negative. Concomitant medications included levothyroxine sodium, celecoxib (CELEXA [CELECOXIB]) and cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]). The patient previously received the first dose of BNT162B2 via an unspecified route of administration on the left arm on an unspecified date at 13:00 (Lot Number: Unknown) as single dose for COVID-19 immunization. On 24Mar2021 at 01:00 AM, the patient experienced continuous rash, cyclical, itching, and burning since second vaccine. Dermatology biopsies indicate allergy to chemical. The events resulted in emergency room visit and physician office visit. No treatment was received. The outcome of events was not recovered. The lot number for BNT162B2, was not provided and will be requested during follow up.

Other Meds: LEVOTHYROXINE SODIUM; CELEXA [CELECOXIB]; ZYRTEC [CETIRIZINE HYDROCHLORIDE]

Current Illness:

ID: 1657875
Sex: F
Age:
State: FL

Vax Date: 05/02/2021
Onset Date: 07/01/2021
Rec V Date: 08/31/2021
Hospital: Y

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: Broke her ankle/Ankle surgery; Diagnosed with bells palsy; Ear kept hurting/Ear ache; Balance issues; Dizziness; Fell; Passing out; Vertigo; Ramsay Hunt syndrome which is shingles in the ear; Ramsay Hunt syndrome which is shingles in the ear; Hearing loss; This is a spontaneous report from a contactable consumer. A 62-year-old female consumer (patient) reported for herself. A 62-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE Solution for injection Lot Number: EP7533) via an unspecified route of administration in arm left on 02May2021 13:30 as dose 2, single for (age at vaccination: 62 years) COVID-19 immunisation. Medical history included overweight from an unknown date and unknown if ongoing she mentions she was a little overweight. Concomitant medications included pregabalin (LYRICA) taken for an unspecified indication from 24Jul2021 and ongoing. Historical vaccine includes bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE Solution for injection Lot Number: EP7533) via an unspecified route of administration in arm left on 10Apr2021 as dose 1, single for (age at vaccination: 62 years) COVID-19 immunisation. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available). Additional Vaccines Administered on Same Date of the Pfizer Suspect If applicable, vaccines administered on same date with the Pfizer vaccine considered as suspect was none. Prior Vaccinations (within 4 weeks), other vaccinations within four weeks prior to the first administration date of the suspect vaccines was none. The adverse events following prior vaccinations was none. On 02Jul2021, the patient experienced ear ache. On 04Jul2021, patient had vertigo, ramsay-hunt syndrome which was shingles in the ear, bell's palsy. On an unknown date Jul2021, had balance issues, hearing loss. On 27Jul2021, had dizziness, patient broke her ankle/ankle surgery, passed out and fell. The patient was in hospital for bell's palsy from 04Jul2021 to 09Jul2021 and for broken ankle from 27Jul2021 to 29Jul2021. The events caused hospitalization. The events resulted in Emergency Room/Physician Office. It was reported that her ear kept hurting for a while and she was admitted to the hospital on 04Jul2021 and was diagnosed with Ramsay Hunt syndrome which was shingles in the ear. She was in the hospital from 04Jul2021 to 09Jul2021 and she still had balance issues and they gave her medicine to take for a while. On 27Jul2021, she had dizziness as she was trying to walk to the bathroom she fell and broke her ankle because of the Ramsay Hunt Syndrome. On 04Jul2021, she was also diagnosed with bells palsy. Caller states she was told her symptoms could be from the vaccine and knows that it could be after the fact but she was wondering if there was any help that could be provided by Pfizer and she needs financial help to pay for doctors bills that she has and they add up to 3000 or 4000 dollars, had insurance but she also has to go to therapy for her ankle and she has hearing loss from the Ramsay Hunt syndrome. Caller states she has also been out of work since 02Jul2021 and she wanted to know if she can be compensated for loss wages. On 02Jul2021, she had gone to the doctor because of her ear ache. She was given Amoxicillin and then on 04Jul2021, she woke up and had vertigo. She got her daughter to come over and help her because she was spinning like crazy. Her daughter stayed with her up until 10 minutes before her husband would get home from work. Her husband got off at 6. From the time her daughter left (10 minutes before her husband arrived home), the Bell's palsy started. She didn't even realize it until her husband looked at her and thought she had a stroke. Her husband took her to Emergency Care which she was then transported by ambulance to the hospital where she was diagnosed with Bell's Palsy and Ramsay Hunt syndrome.Caller clarifies she had balance issues and ended up passing out and falling on 27Jul2021. She spent another 2 days in the hospital. She was in the hospital from 27Jul2021 to 29Jul2021. She had surgery on her ankle the night of 27Jul2021. Lot number was the same for both the first and second dose. She started Lyrica on 24Jul2021, but she had taken Lyrica before and had no problems with it. She was still taking Lyrica with no issues. She confirms she cannot provide any NDC, Lot, or expiry date for the Lyrica as this product was dispensed in a pharmacy vial with just an Rx number. The clinical outcome of the events was unknown.

Other Meds: LYRICA

Current Illness:

ID: 1657876
Sex: M
Age:
State: OH

Vax Date: 06/21/2021
Onset Date: 07/01/2021
Rec V Date: 08/31/2021
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: My muscles are becoming very very weak and theres a pulling kind of sensation in my lower abdomen which is not going away and getting worse.Also my legs become very very weak and I am unable to do my; My muscles are becoming very very weak and theres a pulling kind of sensation in my lower abdomen which is not going away and getting worse.Also my legs become very very weak and I am unable to do my; My muscles are becoming very very weak and theres a pulling kind of sensation in my lower abdomen which is not going away and getting worse.Also my legs become very very weak and I am unable to do my; My muscles are becoming very very weak and theres a pulling kind of sensation in my lower abdomen which is not going away and getting worse.Also my legs become very very weak and I am unable to do my; This is a spontaneous report from a contactable consumer (patient). A 48-year-old male patient received the second dose of BNT162B2 via an unspecified route of administration on the right arm on 21Jun2021 at 03:15 (Lot Number: EW0178) at the age of 48-year-old as single dose for COVID-19 immunization. Medical history included sulfa group allergy. It was unknown whether the patient received other vaccine in four weeks. The patient didn't COVID prior vaccination. The patient didn't perform COVID test post vaccination. The patient didn't received other medications in two weeks. The patient previously received the first dose of BNT162B2 via an unspecified route of administration on the right arm on 28May2021 at 03:15 (Lot Number: EW0178) at the age of 48-year-old as single dose for COVID-19 immunization. On 01Jul2021, the patient's muscles were becoming very very weak and there a pulling kind of sensation in lower abdomen which was not going away and getting worse. Also the legs become very very weak and the patient was unable to do daily chores. The outcome of events was not recovered. The events resulted in emergency room visit and physician office visit. Treatment included physical therapy and CT scan. The outcome of events was not recovered.

Other Meds:

Current Illness:

ID: 1657877
Sex: M
Age:
State: WI

Vax Date:
Onset Date:
Rec V Date: 08/31/2021
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: Tested positive for Covid after both vaccines; Result Unstructured Data: Test Result:Got positive

Allergies:

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

Symptoms: had both doses of the Pfizer vaccine and now has Covid; Had both doses of the Pfizer vaccine and now has Covid; This is a spontaneous report from a contactable consumer (patient's mother) or other non-healthcare professional. A 45-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number and Expiry date was not reported) as DOSE 2, SINGLE and dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number and Expiry date was not reported) as DOSE 1, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient had both doses of the Pfizer vaccine and now has covid. The reporter stated that her son is healthy, and he had both of the Covid vaccines, Pfizer, and he got Covid. The patient underwent lab tests and procedures which included Sars-cov-2 test: got positive on an unspecified date. The outcome of the events was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1657878
Sex: F
Age:
State: NY

Vax Date: 01/19/2021
Onset Date: 01/20/2021
Rec V Date: 08/31/2021
Hospital:

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

Lab Data: Test Date: 20210221; Test Name: covid test; Test Result: Negative ; Comments: Nasal swab; Test Date: 20210224; Test Name: covid test; Test Result: Negative ; Comments: nasal swab; Test Date: 20210712; Test Name: covid test; Test Result: Negative ; Comments: Nasal swab; Test Date: 20210811; Test Name: covid test; Test Result: Negative ; Comments: Nasal swab

Allergies:

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

Symptoms: On 20Jan2021, Right sided Bell's palsy was developed; After Bell's palsy, right-sided cervical radiculopathy started; Now, right-sided trigeminal neuralgia was started.; This is a spontaneous report from a contactable other healthcare professional. A 54 year old non pregnant female patient received bnt162b2 (BNT162B2), dose 1 intramuscular, administered in Arm Left on 19Jan2021 16:00 (Batch/Lot Number: EL3246) as DOSE 1, SINGLE for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient did not have COVID prior vaccination. The patient was tested for COVID post vaccination. On 20Jan2021, the patient experienced Right sided Bell's palsy was developed, After Bell's palsy, right-sided cervical radiculopathy started, Now, right-sided trigeminal neuralgia was started. The patient underwent lab tests and procedures which included sars-cov-2 antibody test negative on 21Feb2021 with nasal swab, sars-cov-2 antibody test: negative on 24Feb2021 with nasal swab, sars-cov-2 antibody test negative on 12Jul2021 with nasal swab and sars-cov-2 antibody test negative on 11Aug2021 with nasal swab. Therapeutic measures were taken as a result of this with Tegetol for trigeminal neuralgia. The outcome of events was unknown. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the events Bell's palsy 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: 1657879
Sex: M
Age:
State: CA

Vax Date: 04/09/2021
Onset Date: 05/01/2021
Rec V Date: 08/31/2021
Hospital:

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

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

Allergies:

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

Symptoms: In the third week, I woke up in the morning and came down with Bells Palsy; After the second shot two week later I became sick with a fever, super tired, and a massive headache at the back of my head behind the ear.; fever; super tired; massive headache at the back of head behind the ear; sick; This is a spontaneous report from a contactable consumer (patient). A 55-year-old male patient received the second dose of BNT162B2 via an unspecified route of administration on the left arm on 09Apr2021 at 12:30 (Lot Number: er8731) at the age of 55-year-old as single dose for COVID-19 immunization. Medical history included high blood pressure. known allergy included mangos. The patient was not COVID prior vaccination. The patient didn't perform COVID test post vaccination. The patient didn't receive other vaccine in four weeks. The patient didn't receive other medication in two weeks. The patient previously received the first dose of BNT162B2 via an unspecified route of administration on the left arm in Mar2021 at 12:30 PM(Lot Number: er2613) as single dose for COVID-19 immunization. On 01May2021 at 07:00 AM , two weeks after the second shot, the patient became sick with a fever, super tired, and a massive headache at the back of head behind the ear. In the third week, the patient woke up in the morning and came down with Bells Palsy. Treatment included predisone. The events resulted in emergency room visit and physician office visit. The outcome of events was recovered with sequel.

Other Meds:

Current Illness:

ID: 1657880
Sex: M
Age:
State:

Vax Date: 01/01/2021
Onset Date:
Rec V Date: 08/31/2021
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: 2021; Test Name: CT of lungs; Result Unstructured Data: Test Result:unknown results; Test Date: 2021; Test Name: COVID-19; Test Result: Positive ; Test Date: 2021; Test Name: X-ray; Result Unstructured Data: Test Result:unknown results

Allergies:

Symptom List: Ear pain, Hypoaesthesia

Symptoms: they ran a COVID test and he tested positive/mild fever; they ran a COVID test and he tested positive/mild fever; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 30Dec2020 (Batch/Lot number was not reported) as dose 1, single dose and on an unspecified date in Jan2021 (three weeks later)(Batch/Lot number was not reported) as dose 2, single dose for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications included blood thinners. The patient received first COVID vaccine on 30Dec2020 and second dose three weeks later. He resided in assisted living facility and had several co-morbidities. He fell was taken to hospital to assess for internal bleeding since he was on blood thinners. He had a mild fever so they ran a COVID test and he tested positive on an unspecified date in 2021. ED physician did X-ray and CT of lungs. Gave patients dose of doxycycline to clear up lungs. Patient home and stable. Event took place after use of product. The outcome of the events was unknown. The lot number for BNT162B2, was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1657881
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/31/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Abdominal pain upper, Dizziness, Dysgeusia

Symptoms: Bell's palsy; numbness in their face and in their arms and finger tips; This is a spontaneous report from contactable consumer. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: not reported, Expiration date: not reported) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date in 2021, patient experienced Bell's palsy and numbness in their face and in their arms and fingertips. Reporter also stated, I was given this number from the CDC so that I can speak with a medical, somebody that is familiar with the adverse side effects that are not the normal side effects from the Pfizer Covid-19 vaccine. We have a patient that has had their first shot and had an adverse reaction of what appear to be the Bell's palsy where they experienced the numbness in their face and in their arms and fingertips and so for. Outcome for 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: 1657882
Sex: F
Age:
State: CA

Vax Date: 04/14/2021
Onset Date: 08/08/2021
Rec V Date: 08/31/2021
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: 20210810; Test Name: Blood test; Test Result: Positive ; Test Date: 20210808; Test Name: Body temperature; Result Unstructured Data: Test Result:101.2; Test Date: 20210809; Test Name: BinaxNow; Result Unstructured Data: Test Result:Negative; Comments: Nasal Swab; Test Date: 20210810; Test Name: BinaxNow; Result Unstructured Data: Test Result:Positive; Comments: Nasal Swab

Allergies:

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

Symptoms: Came down with symptoms on 08Aug2021 - headache, fever of 101.2+ and cough. Tested negative on 8/9/21 with Abbott BinaxNow kit and positive on 8/10/21 with Abbott BinaxNow kit; Came down with symptoms on 08Aug2021 - headache, fever of 101.2+ and cough. Tested negative on 8/9/21 with Abbott BinaxNow kit and positive on 8/10/21 with Abbott BinaxNow kit; This is a spontaneous report from a contactable consumer (patient). A 21-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: ER8729), via an unspecified route of administration, administered in Arm Left on 14Apr2021 (at the age of 21-years-old) as dose 2, single and received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: ER2613) via an unspecified route of administration, administered in Arm Left on 22Mar2021 16:00 (at the age of 21-years-old) as dose 1, single for covid-19 immunization at other. The patient medical history was not reported. There were no concomitant medications. No known allergies and no other medical history. No other vaccine in four weeks and other medications in two weeks. No covid prior vaccination. Covid was tested post vaccination. On 08Aug2021 21:00, the patient came down with symptoms of headache, fever of 101.2+ and cough. Tested negative on 09Aug2021 with Abbott BinaxNow kit and positive on 10Aug2021 with Abbott BinaxNow kit and then positive with hospital clinic test on 10Aug2021. Lost sense of smell and taste but symptoms resolved within 8 days. Still cannot taste much. The adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included body temperature: 101.2 on 08Aug2021, sars-cov-2 test (nasal swab): negative on 09Aug2021, blood test: positive on 10Aug2021, sars-cov-2 test (nasal swab): positive on 10Aug2021. The patient received treatment for events. Received Tylenol for fever and monitoring pulse and oxygen. The outcome of events was recovering. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1657883
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/31/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Lack of drug effect; Lack of drug effect; Localized itching; Unexpected therapeutic benefit; This is a solicited study report from the marketing program received from a contactable consumer (patient). A 58-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscular on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation; risankizumab (SKYRIZI), subcutaneous from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at unknown dose for Moderate to severe chronic plaque psoriasis. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced localized itching, unexpected therapeutic benefit, lack of drug effect on an unspecified date with outcome of not recovered. On unknown dates, the patient experienced itchiness in head, back and buttocks, unexpected benefit/had no joint pain or swelling since starting SKYRIZI and lack of effect. COVID-19 vaccine was also considered suspect. The patient got Covid vaccine and experienced itchiness for about a week or two. He started experiencing itchiness in head, back, and buttocks less than 12 weeks after doing Skyrizi injection. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On unknown date, patient received 1st dose COVID-19 Vaccine. Primary reporter did not have the lot number information, because the packaging was discarded. The action taken in response to the events for risankizumab was unknown. Causality for SKYRIZI(RISANKIZUMAB): The reporter's causality for the events of itchiness in head, back and buttocks, unexpected benefit/had no joint pain or swelling since starting SKYRIZI and lack of effect with SKYRIZI(RISANKIZUMAB) was a reasonable possibility. The reporter's assessment of the causal relationship of the events 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 on the company causality assessment. The lot number for the vaccine, bnt162b2, was not provided and will be requested during follow up.; Sender's Comments: Based on the information provided, known drug safety profile and plausible temporal association, the causality between BNT162B2 and Drug ineffective, Suspected COVID-19, Pruritus and Therapeutic response unexpected cannot be completely excluded.

Other Meds: SKYRIZI [RISANKIZUMAB]

Current Illness:

ID: 1657884
Sex: F
Age:
State:

Vax Date: 07/01/2021
Onset Date:
Rec V Date: 08/31/2021
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: possible blood clotting; burning sensation on her left side particulary her foot and leg same side she got shot in her arm; her toes on left are still a little tingly; This is a spontaneous report from a contactable consumer. This consumer reported for a female other HCP (patient) that the female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number, Expiry Date: not reported), via an unspecified route of administration, administered in arm on an unspecified date in Jul2021 as dose 1, single for covid-19 immunisation. Medical history included history of not responding well to vaccine shots including the flu shot which gave her shingles. No medical conditions beside history of intolerance to vaccines.The patient's concomitant medications were not reported. Patient was a nurse at a dermatology office and she knew who got COVID vaccine in July. She directly reported it to field force (consumer) as both reporter and patient. She experienced a burning sensation on her left side particularly her foot and leg same side she got shot in her arm. She said that her primary care doc was worried about possible blood clotting so advised against her 2nd shot. She said that her toes on left were still a little tingly so she was concerned to take second shot which she was supposed to take on an unspecified date. The outcome of event her toes on left were still a little tingly was not recovered while the outcome of other events was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1657885
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/31/2021
Hospital:

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

Lab Data: Test Name: blood clot; Result Unstructured Data: Test Result:Had blood clot

Allergies:

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

Symptoms: had a blood clot; developed heart issues, and had to have a pacemaker inserted.; lost circulation to his feet/lose his feet from the vaccine; lost circulation to his feet/lose his feet from the vaccine; This is a follow-up spontaneous report from a Pfizer- sponsored program. This consumer reported for a male consumer(patient). This is a third case out of 4 cases. A male patient of an unspecified age was received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot number: not reported), 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. On an unspecified date, the patient had a blood clot, lost circulation to his feet/lose his feet from the vaccine, developed heart issues, and had to have a pacemaker inserted. The reporter reported that, caller states that after three of her family members received the Pfizer Covid-19 vaccine that they all developed blood clots. Outcome of the events 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-202101075369 same reporter/product, different patient / event.

Other Meds:

Current Illness:

ID: 1657887
Sex: M
Age:
State: CA

Vax Date: 07/21/2021
Onset Date: 07/01/2021
Rec V Date: 08/31/2021
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: Thrombosis in Left Leg and Pain; Back pain; he still felt sick; Thrombosis in Left Leg and Pain; This is a spontaneous report from a contactable consumer (patient) reported for himself. A 47-year-old male patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection), dose 2 via an unspecified route of administration, administered in left arm on 21Jul2021 (at the age of 47-years-old) (Batch/Lot Number: EW0198) as dose 2, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient previously took first dose of BNT162B2 (lot number: PA7484, vaccine location: Left arm) on 02Jul2021 for covid-19 immunisation. The patient states that he had pain in his back, so he went to the ER, he still felt sick, so he went to another ER at a different hospital (probably 2 weeks later from the vaccine) and they told him that he had a thrombosis in his leg (on an unspecified date in 2021) and gave him prescriptions and he left the same day. The patient states his second trip to the ER was on 14Aug2021. As the patient still had the same pain (Pain in leg on an unspecified date In Jul2021) so he went back to an ER for a second time because the first time they didn't check his blood or anything. Caller clarifies that he was not admitted to the hospital, he was treated and released from the ER Caller states he is supposed to go to the hospital today, but he has no one to drive him. Regarding treatment reporter stated they gave him Norco for Pain and Xarelto. patient stated he will probably have to go back to the hospital because he did not see any change in this leg, patient stated he will see if they can see him again for more pain medicine. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The outcome of back pain was recovered on an unspecified date in 2021. The outcome of still felt sick was unknown. The outcome of the other events was not recovered. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1657888
Sex: M
Age:
State: NE

Vax Date: 03/22/2021
Onset Date: 03/22/2021
Rec V Date: 08/31/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site pain, Menorrhagia

Symptoms: the patient administered moderna vaccine after the pfizer covid 19 vaccine on 19Aug2021; two doses on one day in 22MAR2021 and a third dose 13APR2021.; patient received three doses of the Pfizer Covid 19 vaccine; This is a spontaneous report from a contactable pharmacist. A 47-years-old male patient received bnt162b2 (BNT162B2, solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on 22Mar2021 (age at the vaccination 47-years-old) as dose 2, single, and dose 1 (Batch/Lot number: ER2613) on 22Mar2021 as dose 1 single, and dose 3 as extra dose on 13Apr2021 as dose 3, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. A patient received three doses of the Pfizer COVID 19 vaccine: two doses on one day in 22Mar2021 and a third dose 13Apr2021. The patient came to the pharmacy and the patient stated he had not had a COVID vaccination, so the patient administered moderna vaccine after the pfizer covid 19 vaccine on 19Aug2021 after the pfizer covid 19 vaccine. The events assessed as medically significant. The outcome of events was unknown. Caller states causality as no, unrelated. Product: Moderna COVID 19 vaccine; treatment 19AUG2021 at 1615PM in left deltoid; lot 017C21A; NDC 80777-273-10; expiration date 19OCT2021; dose 0.5ml. No follow-up attempts are needed; information about lot/batch number cannot be obtained.; Sender's Comments: Based on the known safety profile of the vaccine BNT162B2, a temporal relation between the events: Extra dose administered and Inappropriate schedule of product administration ;and the administration of the vaccine cannot be excluded.,Linked Report(s) : US-PFIZER INC-202101086686 same AE/drug, different patient.

Other Meds:

Current Illness:

ID: 1657889
Sex: F
Age:
State: KS

Vax Date: 04/06/2021
Onset Date: 04/14/2021
Rec V Date: 08/31/2021
Hospital: Y

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

Lab Data: Test Date: 20210801; Test Name: Covid test; Test Result: Negative

Allergies:

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

Symptoms: 70% loss of hearing in both ears within 12 days of vaccine/steady hearing loss; Chewing; swallowing; sore throat; headaches/head pain; Vertigo; double vision in 3 months; This is a spontaneous report from a contactable consumer (patient). A 78-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 06Apr2021 at 10:30 AM (Batch/Lot Number: ER8734) as DOSE 2, SINGLE (at the age of 78-years-old) for COVID-19 immunisation. The patient's medical history was not reported. There were no concomitant medications. The patient had no known allergies. The patient's historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 16Mar2021 at 10:30 AM (Batch/Lot Number: EP7534) as DOSE 1, SINGLE (at the age of 78-years-old) for COVID-19 immunisation. On 14Apr2021, the patient experienced 70% loss of hearing in both ears within 12 days of vaccine/steady hearing loss, chewing, swallowing, sore throat, headaches/head pain, vertigo, and double vision in 3 months. The adverse events resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, hospitalization, disability, or permanent damage. The patient was hospitalized for 1 day for the events. The patient underwent lab tests and procedures which included covid-19: negative on 01Aug2021. The patient did not receive any treatment for the adverse events. 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 been tested for COVID-19 and was negative on 01Aug2021. The patient had not recovered from the events. That information on the Lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1657890
Sex: F
Age:
State: UT

Vax Date: 02/04/2021
Onset Date: 02/01/2021
Rec V Date: 08/31/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Nausea, Pain in extremity, Pyrexia

Symptoms: blood clots on the outside of my legs and torso; dry mouth; dry eyes; This is a spontaneous report from a contactable consumer (patient). An 86-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date: unknown), via an unspecified route of administration on 04Feb2021 (at the age of 86 years) as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiry date unknown), via an unspecified route of administration, administered on an unspecified date in Jan2021 (at the age of 86 years) as dose 1, single for COVID-19 immunization. It was reported that the patient had the second (dose) Pfizer Covid shot on 04Feb2021, the next week on an unknown date in Feb2021, she got dry mouth, dry eyes and then I got little blood clots on the outside of my legs and torso." The patient did not receive any treatment for the events. The outcome of 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: 1657891
Sex: F
Age:
State: MA

Vax Date: 06/08/2021
Onset Date: 06/01/2021
Rec V Date: 08/31/2021
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: I ended up feeling I passed out woke up about 30 seconds after trying to catch my breath and making strange noises with my throat I lost consciousness; I felt a tingling on my left arm and spreading to my back; Shortness of breath; Very dizzy; My throat was swollen, closed, I felt air passage is closed or closing and when I woke up I was making funny noises with my throat trying to clear an air passage; My throat was swollen, closed I felt air passage is closed or closing and when I woke up I was making funny noises with my throat trying to clear an air passage; My arm could not be lifted for 17 hours; Very tired for 2 days 2-4 days; This is a spontaneous report from a contactable consumer or non-HCP reported about herself (patient). A 48-year-old female patient received first dose of bnt162b2 (BNT162B2; Solution for injection; Lot Number: EW0177), via an unspecified route of administration, administered in left arm as dose 1, single on 08Jun2021 13:00 (at the age of 48-year-old) for covid-19 immunisation. The patient medical history, family medical history and concomitant medications were not reported. As per reporter, patient received the first dose of vaccine on 08Jun2021 and about a minute later had some side effects, she felt a tingling on left arm and spreading to her back, shortness of breath, very dizzy and ended up felt she passed out. Patient lost consciousness for 30 seconds and then woke up and had shortness of breath and throat was swollen, closed, she felt air passage was closed or closing, closing and made funny or strange noises with her throat tried to clear an air passage. She laid down for 30 minutes there at the pharmacy where they monitored her and then they sent her home. Patient's arm could not be lifted for 17 hours and just very tired for 2 days, 2-4 days. Patient's doctor recommended to see an allergist and do not get the second dose. Patient do not have a second vaccination appointment. No treatment was received for side effect. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. At the time of this report, outcome of the events was unknown.

Other Meds:

Current Illness:

ID: 1657892
Sex: M
Age:
State: AZ

Vax Date:
Onset Date:
Rec V Date: 08/31/2021
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: Headache, Heart rate increased, Injection site erythema, Injection site pain, Injection site swelling

Symptoms: Developed a blood clot 3 days later; This is a spontaneous report from a contactable physician communicated to a Pfizer sales representative. A male patient of an unspecified age received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), at an unknown route, dose number unknown, single for COVID-19 immunization. The patient medical history included DVT from an unknown date and unknown if ongoing. The patient received Eliquis for DVT. The patient concomitant medications were not reported. The patient developed a blood clot 3 days later. The patient received treatment for the event. The outcome of 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: Based on the information available and close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported event Thrombosis . The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Other Meds:

Current Illness:

ID: 1657893
Sex: F
Age:
State: CO

Vax Date: 08/19/2021
Onset Date: 07/30/2021
Rec V Date: 08/31/2021
Hospital:

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

Lab Data: Test Date: 20210721; Test Name: Nasal Swab/Binaxnow; Test Result: Negative ; Comments: Hospital test; Test Date: 20210731; Test Name: Nasal Swab/Binaxnow; Test Result: Negative ; Comments: Binaxnow; Test Date: 20210821; Test Name: Nasal Swab/Binaxnow; Test Result: Positive ; Comments: Binaxnow

Allergies:

Symptom List: Nausea

Symptoms: covid test date=21Aug2021, covid test result=Positive/Body aches, lost of smell and taste; covid test date=21Aug2021, covid test result=Positive/Body aches, lost of smell and taste; Body aches; Lost of smell and taste; Lost of smell and taste; This is a spontaneous report from a contactable other health care professional (patient). A 39-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: FA7485), via an unspecified route of administration, administered in arm left on 29Jul2021 at 12:30 PM (at the age of 39 years) as DOSE 1, SINGLE and second dose of bnt162b2 (Batch/Lot Number: FC3182) via an unspecified route of administration, administered in arm left on 19Aug2021 at 08:30 AM (at the age of 39 years) as DOSE 2, SINGLE for covid-19 immunisation. The patient was not pregnant at the time of vaccination. Vaccine was administered at pharmacy or drug store. No other vaccines were received within four weeks prior to the administration of bnt162b2. Medical history included asthma, neurofibromatosis and penicillin allergy; all from an unknown date and unknown if ongoing. Concomitant medication included montelukast sodium (SINGULAIR) taken within two weeks of vaccination for an unspecified indication, start and stop date were not reported. On 30Jul2021 at 07:30 AM, the patient experienced body aches, lost of smell and taste. The report was non serious (as reported). On 21Jul2021, the patient underwent covid test post vaccination at hospital with covid test type nasal swab: negative, on 31Jul2021, covid test post vaccination as Binaxnow test with covid test type nasal swab: negative, on 21Aug2021, covid test post vaccination as Binaxnow test with covid test type nasal swab: positive. Events were considered as medically significant. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was tested for COVID-19. No treatment was received for the adverse events. Outcome of the events was not recovered.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported event Covid 19 and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.

Other Meds: SINGULAIR

Current Illness:

ID: 1657894
Sex: F
Age:
State: NJ

Vax Date: 02/23/2021
Onset Date: 07/24/2021
Rec V Date: 08/31/2021
Hospital:

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

Lab Data: Test Date: 202002; Test Name: blood work; Result Unstructured Data: Test Result: Normal; Test Date: 202106; Test Name: blood work; Result Unstructured Data: Test Result: Elevated liver enzymes; Test Name: Elevated liver enzymes; Result Unstructured Data: Test Result: levels went back down; Comments: Her liver enzymes were re-tested a month later and her levels went back down; Test Date: 202106; Test Name: Elevated liver enzymes; Result Unstructured Data: Test Result: Elevated liver enzymes; Comments: Elevated liver enzymes; Test Name: genetic molecular studies; Result Unstructured Data: Test Result: Essential thrombocytosis; Comments: She had genetic molecular studies and everything came back fine except she was diagnosed with Essential thrombocytosis; Test Date: 202106; Test Name: MRI; Result Unstructured Data: Test Result: Normal; Test Name: Platelet count; Result Unstructured Data: Test Result:650,000; Comments: elevated clotting platelet; Test Date: 202002; Test Name: Platelet count; Result Unstructured Data: Test Result: Normal; Test Date: 202106; Test Name: Platelet count; Result Unstructured Data: Test Result:592,000; Comments: elevated clotting platelet; Test Date: 202106; Test Name: covid-19 test; Result Unstructured Data: Test Result: Not Positive; Test Date: 202106; Test Name: ultrasound scan; Result Unstructured Data: Test Result: things on liver, had Fatty liver; Comments: they saw things on liver and that she had a fatty liver.

Allergies:

Symptom List: Injection site pain

Symptoms: All three tested positive for COVID and she was the only one who didn't; fatty liver; her immunity is lower now; Essential thrombocytosis; clotting platelet elevated; Elevated liver enzymes; head pain; shooting pain going across her head, from the base of her neck up to the middle of her and also around the top of head/left temple was always where her headaches were; strange sensation in the nerves; had fatigue, fatigue in arm; had fatigue, fatigue in arm; This is a spontaneous report from a contactable consumer (patient). A 66-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE mRNA, formulation: solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 23Feb2021 (Batch/Lot Number: EL9266) as DOSE 2, SINGLE (at the age of 65-years-old), dose 1 via an unspecified route of administration on 05Feb2021 (Batch/Lot Number: EL3302) as DOSE 1, SINGLE (at the age of 65-years-old) for COVID-19 immunisation. The patient's medical history included ongoing haemangioma, what they thought were lesions on her liver were hemangioma's which she has had for 15 years and known about. Concomitant medications included calcium and vitamin D NOS. The patient on an unspecified date in 2021, experienced head pain; shooting pain going across her head, from the base of her neck up to the middle of her and also around the top of head/left temple was always where her headaches were, platelets have been elevated, essential thrombocytosis, and elevated liver enzymes. The patient took the Pfizer COVID 19 vaccine, queried whether there were any reports of elevated clotting platelet after taking the vaccine. The patient mentioned that she had a normal platelet count in Feb2020 and all of a sudden, her clotting platelet elevated after she got the vaccine. The caller explained she had shooting pain going across her head, from the base of her neck up to the middle of her and also around the top of head. It was like strange sensation in the nerves. It was like a tension headache where a part of it did not materialize. Caller stated that she had fatigue, fatigue in arm, and other things but the rest of it was pretty normal. The caller explained her clotting platelets have been elevated. She was normal before. In Feb2020, she had blood work, and everything was normal. At the time of report, her clotting platelets were elevated, and she was diagnosed with essential thrombocytosis which meant her body was making too many platelets. The caller stated that the shooting pain in her head just kind of randomly happened. She had it weeks later and it went away. She was alarmed by it. She was on her computer and all of a sudden out of nowhere, she had this strange head pain. She does not remember whether it was after the first or second dose of the COVID vaccine, she has not had it again. She stated it was not like a normal headache and where her normal headaches were. She clarified her left temple was always where her headaches were. This was not normal headache; it was a different kind of pain in her head. What concerned her more is why all of a sudden, she was having this weird blood disorder. She explained she went from 592,000 and then a month later went to 650,000. The doctor was planning to check her in 3 months to ensure her levels were not getting any whackier. She was reading stuff about this happening to people with their white blood cell count and she wanted to know whether there was any correlation with these things. And whether did it trigger a mutation in her bone marrow. The patient queried whether it was a lifelong sickness. She was worried she would spend the rest of her life dealing with this and that she may be shooting off blood clots and have a fatal incident from a blood clot. And now, they were pushing getting the booster shot. She wanted to know why she should need more now. Caller made the comment that she was with three people on 24Jul2021, inside at dinner. She was with person who was coughing their brains out but had a mask on, another person who was not wearing a mask, and the third person who only had one shot. All three tested positive for COVID and she was the only one who did not. She clarified she still had immunity obviously, and she does not want to get another shot. The caller asked whether she should get an antibody test to see how many antibodies she has left. The doctor told even if she does not have antibodies, it does not mean the efficacy of the vaccine was not good. She does not want to over immunize herself especially after freaking out about these clotting platelets. The caller stated the doctors do not think it was the COVID vaccine although it takes years of research and data to come up with answers and correlations. She was just on the more curious side of life and always trying to find out how to save people and help people. The caller stated she has to save herself because it was a dangerous situation, she has to live in. Caller explained she does not have any medical conditions or anything. She was only taking Calcium which she had been taking for a couple of years. She had never taken anything. She was taking Vitamin D, but she was fine at the time of the vaccine. Her immunity was lower at the time of reporting than it was probably was then because she has been hiding in the house. She clarified she was on Vitamin D, but she does not take anything different or new. The caller stated she had not gone near a doctor until she went in Feb2021 for her annual. She was thrilled she had gotten that over with. It was only after the vaccine, her levels started to go back up this Jun2021. She hurt herself at the gym and thought she broke a rib, so she went to the doctor for that. They did blood work, and her liver enzymes were elevated. She was sent for an ultrasound which scared her because she was told they saw things on liver and that she had a fatty liver. She was skinny and does not eat fatty food. She was scheduled for an MRI and her MRI came back normal; her liver enzymes went back to normal which was bizarre. It was determined through her MRI, that what they thought were lesions on her liver were hemangioma's which she has had for 15 years and known about. They sent her merrily on her way. The patient's liver enzymes were re-tested a month later and her levels went back down. One of the readings, GGP or GPG or something (caller was not sure what it was called), still showed high and they thought that was a fatty liver. She lost 5lbs and was trying to lose fat. She then had elevated platelets. They tested her again and her platelet levels went up more. She had genetic molecular studies, and everything came back fine except she was diagnosed with essential thrombocytosis which was a genetic thing where she was making too many platelets. This was out of the clear blue and the caller was wondering if there was any correlation with the Covid vaccine. The patient did not want to get the booster shot and it made her platelet levels go off the chart and she have to take serous medications with serious side effects. She has read these medications could cause serious side effects such as non-melanoma skin cancers, and it was dangerous. The patient underwent lab tests and procedures which included blood work: normal on an unspecified date in Feb2020, blood work: elevated liver enzymes on an unspecified date in Jun2021, elevated liver enzymes: elevated liver enzymes on an unspecified date in Jun2021, elevated liver enzymes: levels went back down on an unspecified date, liver enzymes were re-tested a month later and her levels went back down, , investigation: essential thrombocytosis, she had genetic molecular studies and everything came back fine except she was diagnosed with essential thrombocytosis , magnetic resonance imaging: normal on Jun2021, platelet count: 592,000 on an unspecified date in Jun2021 and 650,000 elevated clotting platelet, platelet count: normal on an unspecified date in Feb2020, COVID-19 test : not positive on Jun2021, ultrasound scan: they saw things on liver and that she had a fatty liver, on an unspecified date in Jun2021 they saw things o

Other Meds: CALCIUM; VITAMIN D NOS

Current Illness: Hemangioma (thought were lesions on her liver were hemangioma's which she has had for 15 years and known about).

ID: 1657895
Sex: M
Age:
State: CA

Vax Date: 03/15/2021
Onset Date: 08/17/2021
Rec V Date: 08/31/2021
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 induration, Injection site pruritus, Injection site swelling, Injection site warmth

Symptoms: Bell's Palsy; This is a spontaneous report from a contactable consumer or other non hcp. A 44-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration, administered in left arm on 15Mar2021 15:00 (Batch/Lot number was not reported, age at vaccination 44-year-old) as single for COVID-19 immunisation. Medical history was reported as none and concomitant medications were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number was not reported) via an unspecified route of administration, administered in left arm on 22Feb2021 03:00 pm as single dose for COVID-19 immunisation. On 17Aug2021 13:00, the patient experienced bell's palsy. He received treatment medications as prednisone and valacyclovir. The seriousness of event considered as disability. It was reported that patient had emergency room visit and physician office visit. He had no known allergies. No COVID prior vaccination and no COVID tested post vaccination. No other vaccine in four weeks and no other medications in two weeks. The outcome of event was not recovered. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

Date Died: 03/24/2021

ID: 1657896
Sex: M
Age:
State: PA

Vax Date: 02/13/2021
Onset Date: 02/20/2021
Rec V Date: 08/31/2021
Hospital: Y

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: Nasal Swab; Test Result: Negative ; Test Name: urinalysis; Result Unstructured Data: Test Result:normal

Allergies:

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

Symptoms: treated for suspected UTI (though urinalysis was normal) with antibiotic; kidney failure; He passed away on 24Mar2021 due to heart failure; diagnosed with pericarditis; Developing fever; weakness; This is a spontaneous report from a contactable consumer. A 81-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 13Feb2021 12:00 (Batch/Lot number was not reported) (at age of 81-year-old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included atrial fibrillation, stroke, kidney disease, hyperlipidemia and Known allergies: NKDA. There was no other vaccine in four weeks. Concomitant medications included rivaroxaban (XARELTO); allopurinol; and acetylsalicylic acid (ASPIRIN 81). On 20Feb2021, The patient started developing fever, weakness. Saw family Dr on 26Feb2021, treated for suspected UTI (though urinalysis was normal) with antibiotic. On 01Mar2021 high fever returned with extreme weakness. Admitted to hospital from 01Mar2021 to 18Mar2021 and diagnosed with pericarditis. He was sent home on Hospice. He passed away on 24Mar2021 due to heart failure. Prior to the vaccination, he was having no symptoms of infection, he was active and healthy, and he was seeing a cardiologist regularly.AE resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event), Patient died on 24Mar2021. Death cause: heart failure, kidney failure. AE treatment: numerous medications given during hospitalization. No covid prior vaccination.Covid tested post vaccination: was Yes. Covid test type post vaccination: Nasal Swab, Covid test result: Negative. No autopsy performed. The outcome of the events heart failure and kidney failure was fatal, of the rest of events was unknown. The lot number for BNT162b2, was not provided and will be requested during follow up; Reported Cause(s) of Death: kidney failure; heart failure

Other Meds: XARELTO; ALLOPURINOL; ASPIRIN 81

Current Illness:

ID: 1657897
Sex: F
Age:
State: NC

Vax Date: 05/28/2021
Onset Date: 05/28/2021
Rec V Date: 08/31/2021
Hospital: Y

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

Lab Data:

Allergies:

Symptom List: Tremor

Symptoms: left arm became tingly; left arm numb; listless; began to swell 13 minutes after the vaccine.; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 28May2021 08:30 (Lot Number: EW0183) (at age of 61-year-old) as DOSE 2, SINGLE for covid-19 immunisation. Patient took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unknown date at age of 61-year-old at left arm for covid-19 immunization. Patient was not pregnant. There was known allergies. No covid prior vaccination, no covid tested post vaccination. Medical history included IBS-D, Fibromyalgia, Sciatic Nerve Nerve, degenerative Joint Disease, TMJ Syndrome. There were no concomitant medications. No other vaccine in four weeks. The patient experienced left arm became tingly, numb, listless and began to swell 13 minutes after the vaccine. Events onset date was reported as 28May2021 08:30 AM. AEs resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event), hospitalization for 3 days. Patient received treatment for the adverse events. The outcome of events was not recovered.

Other Meds:

Current Illness:

ID: 1657898
Sex: M
Age:
State: AZ

Vax Date: 08/07/2021
Onset Date: 08/15/2021
Rec V Date: 08/31/2021
Hospital:

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

Lab Data: Test Date: 20210815; Test Name: microscopic research; Result Unstructured Data: Test Result:dangers possibility of blood clotting

Allergies:

Symptom List: Erythema, Pruritus

Symptoms: i see stacked cells and dangers possibility of blood clotting; Feeling deathly ill; Cellularly my body having difficult time communicating to my brain; Inflammation of many internal organs; physical internal pain; i am deeply intuitively feeling that this is spiritual warfare; This is a spontaneous report from a contactable consumer (patient). A 28-year-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in arm right on 07Aug2021 14:00 (Lot Number: EW0217) at age of 28-year-old as single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. No other vaccine in four weeks.The patient experienced Its a poison to my body, Feeling deathly ill, Cellularly my body having difficult time communicating to my brain., Inflammation of many internal organs never felt this way ever in my life. After conducting microscopic research with microscope I see stacked cells and dangers possibility of blood clotting. As a spiritual being who communicates with divine entities, This is 100% the work of the devil. Not only am I receiving physical internal pain but I am deeply intuitively feeling that this is spiritual warfare. Adverse event start date was 15Aug2021 at time of 14:00. AE resulted in: Life threatening illness (immediate risk of death from the event). No treatment received. No covid prior vaccination. No covid tested post vaccination. The outcome of events was not recovered. No follow up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1657899
Sex: F
Age:
State: KY

Vax Date:
Onset Date:
Rec V Date: 08/31/2021
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: complete hearing loss in her right ear; This is a spontaneous report from a Pfizer-sponsored program. A contactable 77-year-old female consumer (patient) reported that she received second dose of bnt162b2 (COVID 19 Vaccine, mRNA, Solution for injection, Batch/Lot Number, Expiry Date: not reported), via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunization. The patient medical history was not reported. Concomitant medication(s) included clopidogrel bisulfate (PLAVIX) and aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]) for blood thinners (when she received the vaccine). Other concomitant medication included adalimumab (HUMIRA) taken for an unspecified indication, start and stop date were not reported. The patient was previously received as first dose of bnt162b2 (COVID 19 Vaccine, mRNA, Solution for injection, Batch/Lot Number, Expiry Date: Unknown), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunization. She received both doses of COMIRNATY. After receiving her second dose at 10 AM, caller stated that, on an unspecified date, she had complete hearing loss in her right ear at 8 PM the same day. The event was serious (medically significant). Caller sought information on this side effect with COMIRNATY vaccine. Caller stated that she did not blame Pfizer, but she wished there was information out there whether or not she should take the booster dose. The outcome of event was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds: ASPIRIN [ACETYLSALICYLIC ACID]; HUMIRA; PLAVIX

Current Illness:

ID: 1657900
Sex: F
Age:
State: TN

Vax Date: 07/06/2021
Onset Date: 08/20/2021
Rec V Date: 08/31/2021
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: 20210820; Test Name: Nasal swab; Test Result: Positive ; Comments: Nasal Swab

Allergies:

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

Symptoms: my 13 year old daughter received her 2nd covid vaccine on 06Jul2021 and tested positive for covid 20Aug2021; my 13 year old daughter received her 2nd covid vaccine on 06Jul2021 and tested positive for covid 20Aug2021; This is a spontaneous report from a contactable consumer. This consumer reported for a 13-year-old female consumer (daughter) that: A 44-year-old (non-pregnant) female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EW0196), via an unspecified route of administration, administered in Arm Left on 06Jul2021 (at the age of 44-years-old) as DOSE 2, SINGLE and patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EW0196), via an unspecified route of administration, administered in Arm Left on 04Jun2021 (at the age of 44-years-old) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. Patient was not pregnant at the time of vaccination. It was reported that no other vaccine administered in four weeks. Prior to vaccination, the patient did not diagnose with COVID-19. The patient did not tested for COVID-19 post vaccination. The patient experienced my 13 year old daughter received her 2nd covid vaccine on 06Jul2021 and tested positive for covid 20Aug2021 on 20Aug2021. Therapeutic measure were taken as no as a result of event. The patient underwent lab tests and procedures which included Nasal swab (sars-cov-2 test): positive on 20Aug2021 (Nasal Swab). The outcome of event was unknown

Other Meds:

Current Illness:

Date Died:

ID: 1657901
Sex: M
Age:
State: OH

Vax Date:
Onset Date:
Rec V Date: 08/31/2021
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: death; This is a spontaneous report from a Pfizer-sponsored-program. A contactable consumer reported that a male patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on unspecified date at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The reporter stated "You are despicable. Your VAX caused my dad's death. Apparently, lives are disposable as long as you make your money. I hope your family members don't die slow, agonizing deaths from this vax like my dad did". It was unknown if autopsy was done. The outcome of the event was fatal. Information on the lot/batch number has been requested.; Reported Cause(s) of Death: death

Other Meds:

Current Illness:

Date Died:

ID: 1657902
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/31/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: died; This is a spontaneous report from a contactable consumer. An 18-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number and expiration date not provided) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient died on an unspecified date due to unknown cause of death. Unknown treatment received. It was unknown if an autopsy was performed. The lot number for BNT162B2 was not provided and will be requested during follow up.; Reported Cause(s) of Death: died

Other Meds:

Current Illness:

ID: 1657903
Sex: M
Age:
State: ME

Vax Date: 03/11/2021
Onset Date: 03/13/2021
Rec V Date: 08/31/2021
Hospital: Y

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

Lab Data: Test Name: ALS; Test Result: Negative; Test Name: HIV test; Test Result: Negative; Test Date: 20210320; Test Name: Sedimentation rate increased; Result Unstructured Data: Test Result:400; Test Name: Syphilis; Test Result: Negative.

Allergies:

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

Symptoms: tingling around his clavicle and extreme weakness; inflammatory markers were up to 400; tingling around his clavicle and extreme weakness; severe neuropathy; On the 30Jul2021 the caller got the Johnson and Johnson covid vaccine; On the 30Jul2021 the caller got the Johnson and Johnson covid vaccine; Sedimentation rate increased; couldn't do anything- couldn't boost himself up in the bed; got weaker as the week progressed and by Friday he was extremely weak; discomfort around the upper chest around the clavicle; vasculitis; This is a spontaneous report from a Pfizer sponsored program via Regulatory Authority. A 69-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: EN6208) via an unspecified route of administration, administered in Arm Left on 11Mar2021 at 11:15 as DOSE 1, SINGLE (at the age of 69-years-old) for covid-19 immunisation; Covid-19 vaccine janssen (COVID-19 VACCINE JANSSEN), via an unspecified route of administration from 30Jul2021 (Batch/Lot number was not reported) to 30Jul2021, at DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history included diabetes mellitus, blood pressure measurement, hypertension. The patient's concomitant medications were not reported. The patient experienced tingling around his clavicle and extreme weakness and was subsequently hospitalized for 13 days from 20Mar2021 to 01Apr2021. Patient reported that no one could tell him how to proceed, whether to get the 2nd dose of the Pfizer product or not. Patient reported not receiving any recommendations, but his doctor told him, "if you insist on getting it, don't get a mRNA-based vaccine" and there were some physicians who told him "given that you have IVIG you probably have enough antibodies" and other doctors saying "if the IVIG was higher prior to getting vaccinated, it might not have given you any benefit". The patient received the Johnson & Johnson Covid19 vaccine on 30Jul2021, having decided on his own. Patient was looking for guidance on how to proceed moving forward, especially with "booster's being recommended". Patient wanted to know how protected he might be having gotten one dose of the Pfizer Covid19 vaccine and one dose of the Johnson & Johnson Covid19 vaccine? Patient stated "I trusted the Pfizer more than any other, which is why I took that" and "I think I'll just stick with J&J. It appears I can take that without side effects. It remains a viable option for me." stating he'd wait for their guidance regarding booster doses. The patient was admitted as an inpatient for 13 days and diagnosed with severe neuropathy from the vaccine. The patient's inflammatory markers were up to 400. The patient was told not to get a second dose of the Pfizer covid vaccine. On the 30Jul2021 the patient got the Johnson and Johnson covid vaccine because no one could tell him when he cold get his second dose. The patient was now wondering how protected he is? Should the patient get the Pfizer covid booster vaccine? The patient started having symptoms on 13Mar2021 but they were never severe. On 15Mar2021 the symptoms the patient had was discomfort around the upper chest around the clavicle, but patient didn't have any pain. On 15Mar2021 the patient PCP diagnosed him with vasculitis and prescribed prednisone. The patient got weaker as the week progressed and by Friday he was extremely weak. The patient's PCP told him to go to the emergency room. The patient went to the emergency room on 20Mar2021 and the providers saw his sedimentation rate was 400 and they admitted him. The other marker they checked was 297, but the patient did not know the name of it. The neuropathy got worse and he could move his limbs but couldn't do anything- couldn't boost himself up in the bed. The patient could feed himself but not get up. The patient was incorrectly diagnosed with vasculitis by his PCP when the weakness was actually severe neuropathy. The outcome of the event severe neuropathy was not resolved and outcome of other events was unknown. Investigation: On 09Aug2021 the caller got his sedimentation rate checked and it was below 20. The caller was tested in the hospital for everything imaginable because they were looking for any kind of underlying disorders. The caller was tested for HIV and syphilis and was negative. They even considered ALS, Guillian Barre, or a tick borne disease. They found nothing and everything was negative. The last 5 days of the hospitalization the caller had IVIG administered. But the caller was already improving prior to the IVIG, he measured his improvement based on if he could boost himself up in bed. The caller got 5 days worth of the IVIG. Result: 400. The infectious disease doctor had talked to the Pfizer nurse who passed on her their observation of what is going on when the caller was in the hospital. Communication: PC filed. The caller was provided with phone number, option 3, and hours of operation of Monday through Friday, 8AM to 8PM EST, prior to warm transfer to withheld: INT-#. Description of Product Complaint: The caller had the first dose of the Pfizer covid vaccine on 11Mar2021. The caller was told not to get a second dose of the Pfizer covid vaccine. On the 30Jul2021 the caller got the Johnson and Johnson covid vaccine because no one could tell him when he cold get his second dose. The caller is now wondering how protected he is? Should the caller get the Pfizer covid booster vaccine? Pfizer covid vaccine lot EN6208, NDC and expiration date unknown. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1657904
Sex: M
Age:
State: MI

Vax Date: 04/26/2021
Onset Date:
Rec V Date: 08/31/2021
Hospital: Y

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

Lab Data: Test Date: 2021; Test Name: Fevers; Result Unstructured Data: Test Result:102; Test Date: 2021; Test Name: Brain natriuretic peptide; Result Unstructured Data: Test Result:Unknown; Test Date: 2021; Test Name: C-reactive protein; Result Unstructured Data: Test Result:Increased; Test Date: 2021; Test Name: Ejection fraction; Result Unstructured Data: Test Result:Decreased; Test Date: 2021; Test Name: Red blood cell sedimentation rate; Result Unstructured Data: Test Result:Increased; Test Date: 2021; Test Name: Respiratory Viral Panel; Result Unstructured Data: Test Result:Unknown; Test Date: 2021; Test Name: SARS-COV-2 Test; Test Result: Negative ; Test Date: 2021; Test Name: Troponin I; Result Unstructured Data: Test Result:Increased; Test Date: 2021; Test Name: White blood cell count; Result Unstructured Data: Test Result:Increased

Allergies:

Symptom List: Pain in extremity

Symptoms: Fevers with a Tmax of 102; Chills; Conjunctivitis; Stocking glove rash to the hands and feet; C-reactive protein increased; Ejection fraction decreased; Red blood cell sedimentation rate increased; Tongue eruption; Troponin I increased; White blood cell count increased; Respiratory Viral Panel; Brain natriuretic peptide; This is a spontaneous report from a non contactable consumer, reports were pulled from the FDA VAERS site by a Pfizer Colleague. The consumer reported for a 17-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: none, Expiry Date: not reported),via intramuscular on an unknown site on 26Apr2021 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number, Expiry Date: not reported), via an unspecified route on an unspecified date as dose 1, single for covid-19 immunisation. Patient presented 4 days after the start of symptoms, which started 14 days after the second dose of the vaccine. Patient presented with fevers with a Tmax of 102, chills, conjunctivitis, stocking glove rash to the hands and feet, C-reactive protein increased, ejection fraction decreased, red blood cell sedimentation rate increased, tongue eruption, troponin I increased, white blood cell count increased, respiratory viral panel, brain natriuretic peptide on an unknown date in 2021. The patient was hospitalized for 3 days due to all events on an unspecified date and all events were considered as life-threatening. The patient did not visit emergency room or physician office. The patient underwent lab tests and procedures on an unspecified date in 2021 which included body temperature: 102, brain natriuretic peptide: unknown, c-reactive protein: increased, ejection fraction: decreased, red blood cell sedimentation rate: increased, respiratory viral panel: unknown, sars-cov-2 test: negative, troponin i: increased, white blood cell count: increased. The outcome of all event was recovered on unspecified date in 2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1657905
Sex: M
Age:
State:

Vax Date: 06/06/2021
Onset Date: 06/06/2021
Rec V Date: 08/31/2021
Hospital: Y

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

Lab Data: Test Name: blood lactic acid; Result Unstructured Data: Test Result:increased; Test Date: 20210606; Test Name: EKG; Result Unstructured Data: Test Result:pericarditis Positive; Comments: pericarditis Positive; Test Date: 20210606; Test Name: lactic acidosis; Result Unstructured Data: Test Result:5.5; Comments: peaking at 5.5; Test Date: 20210606; Test Name: troponin; Result Unstructured Data: Test Result:increased; Comments: peaking at 2.9 approximately

Allergies:

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

Symptoms: septic shock with myopericarditis; septic shock with myopericarditis; rigors; fever; diffuse maculopapular rash; tachycardic; tachypneic; blood lactic acid increased; electrocardiogram abnormal; lactic acidosis; troponin increased; This is a spontaneous report from a non-contactable consumer or other non hcp. A 18-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: unknown), via intramuscular route of administration, administered on 06Jun2021 as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: unknown), via unspecified route of administration, administered on unspecified date as single dose for COVID-19 immunisation. It was reported that medications at time of Vaccination was none. No known allergies. The patient experienced septic shock with myopericarditis, rigors, fever, diffuse maculopapular rash, tachycardic, tachypneic, blood lactic acid increased, electrocardiogram abnormal, lactic acidosis, troponin increased on 06Jun2021. Symptoms started out with rigors and a fever. This progressed to a diffuse maculopapular rash that resolved within 24 hours. It was reported that event were Serious, Life Threatening Hospitalized and patient visited emergency room. It was reported that Permanent Disability and Congenital Anomaly / Birth Defect was no. Following day, he was tachycardic and tachypneic when he presented to the emergency department. Ultimately he was found to be in septic shock with myopericarditis. He required pressors. He was currently still in the hospital. It was reported that Prolonged Hospitalization Existence was no and days in hospital was unknown. The patient underwent lab tests and procedures which included blood lactic acid: increased, electrocardiogram: pericarditis positive on 06Jun2021 (pericarditis Positive), lactic acidosis: 5.5 on 06Jun2021(peaking at 5.5), troponin: increased on 06Jun2021 (peaking at 2.9 approximately. The outcome of event septic shock with myopericarditis , tachycardic, tachypneic, blood lactic acid increased, electrocardiogram abnormal, lactic acidosis and troponin increased was not recovered and for rest event outcome was recovered on 07Jun2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

Date Died:

ID: 1657906
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/31/2021
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: lost a friend; This is a spontaneous report from a non-contactable consumer reporting same event under the same suspect product for 12 patients. This is one of 12 reports. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified routed of administration on unspecified date as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The reporter had lost a friend. The cause of death was unknown. It was unknown if autopsy was done. The outcome of the event was fatal. 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-202101100128 Same reporter/event/drug, different patient;US-PFIZER INC-202101100129 Same reporter/event/drug, different patient;US-PFIZER INC-202101100127 Same reporter/event/drug, different patient; Reported Cause(s) of Death: lost a friend

Other Meds:

Current Illness:

Date Died:

ID: 1657907
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/31/2021
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: I have lost 3 friends in Spain; This is a spontaneous report from a non-contactable consumer. This consumer reported similar events for twelve patients. This is one of twelve reports. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified routed of administration on unspecified date as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The reporter stated "I have lost 7 friends in , 3 in , 1 in and a friend of my son 14 years." The cause of death was unknown. It was unknown if autopsy was done. The outcome of the event was fatal. 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-202101100059 Same reporter/event/product, different patient; Reported Cause(s) of Death: lost 3 friends

Other Meds:

Current Illness:

Date Died:

ID: 1657909
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/31/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Vomiting

Symptoms: lost a friend of my son 14 years; This is a spontaneous report from a non-contactable consumer reporting same event under the same suspect product for 12 patients. This is one of 12 reports. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified routed of administration on unspecified date as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The reporter had lost a friend of the reporter's son 14 years (seems the reporter's son's age who is not the patient). The cause of death was unknown. It was unknown if autopsy was done. The outcome of the event was fatal. 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-202101100059 Same reporter/event/drug, different patient; Reported Cause(s) of Death: lost a friend of my son 14 years

Other Meds:

Current Illness:

ID: 1657910
Sex: F
Age:
State: TX

Vax Date: 02/23/2021
Onset Date: 02/24/2021
Rec V Date: 08/31/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Headache, Limb discomfort, Nasal congestion

Symptoms: Renal failure; periodic uncontrollable shaking; This is a spontaneous report from a contactable consumer. A 94-years-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 23Feb2021 12:00 (Batch/Lot number was not reported) (at the age of 94-years-old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history was none, she was just old. There were no known allergies. The patient did not get covid prior vaccination. There was no other vaccine in four weeks. Concomitant medications in two weeks included temazepam; ascorbic acid, calcium, minerals nos, retinol, tocopheryl acetate, vitamin b nos, vitamins nos, zinc (CENTRUM SILVER); ascorbic acid, retinol, tocopherol (OCUVITE) all taken for an unspecified indication, start and stop date were not reported. The patient experienced renal failure and periodic uncontrollable shaking on 24Feb2021 13:00. The events resulted in doctor or other healthcare professional office/clinic visit. There was no treatment received. The outcome of the event periodic uncontrollable shaking and renal failure was unknown. Covid was not tested post vaccination. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds: TEMAZEPAM; CENTRUM SILVER [ASCORBIC ACID;CALCIUM;MINERALS NOS;RETINOL;TOCOPHERYL ACETATE;VITAMIN B NOS;VITAMINS; OCUVITE [ASCORBIC ACID;RETINOL;TOCOPHEROL]

Current Illness:

ID: 1657911
Sex: M
Age:
State:

Vax Date: 08/01/2021
Onset Date:
Rec V Date: 08/31/2021
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: glaucoma; sharp pains to his right middle and index fingers; sharp pains to feet and toes of both feet; sharp pains to feet and toes of both feet; far sight is blurry; slight numbness to the right side of his face; dull pain in his stomach; This is a spontaneous report from a contactable consumer. This male consumer (patient) reported that: A male 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, administered in Arm Right on Aug2021 as DOSE 2, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered on unspecified date as DOSE 1, SINGLE for covid-19 immunization. On an unspecified date, the patient experienced glaucoma, sharp pains to his right middle and index fingers, sharp pains to feet and toes of both feet, sharp pains to feet and toes of both feet, far sight is blurry, slight numbness to the right side of his face, dull pain in his stomach. Consumer called about the Pfizer COVID-19 vaccine who said it has been a week since he got his second injection and he is still experiencing side effects. He said that he has a dull pain in his stomach also that feels like he got punched in the stomach that hasn't gone away and has slight numbness to the right side of his face, which he had the shot in his right side arm. He do not know if it has to do with his glaucoma or not, but before all the shots his vision was good, now looking further his far sight is blurry. He said he called the eye doctor and has an appointment to check that out and seemed like everyone he knows was done with all side effects in one to two days, so he was concerned that he still has the feeling like he was punched in the stomach. Caller declined to complete a report, and says he just needed to know if this could be life threatening or if he just needed to see his doctor. No further details provided about other people who had side effects. Event glaucoma was considered as serious (medically significant). The clinical outcome of events were unknown. Information on the Lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1657912
Sex: F
Age:
State: IL

Vax Date: 01/20/2021
Onset Date: 01/20/2021
Rec V Date: 08/31/2021
Hospital: Y

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

Lab Data:

Allergies:

Symptom List: Injection site swelling, Limb discomfort

Symptoms: difficulty swallowing; lightheaded; anaphylaxis; obstructed airway; stridor; inability to talk; This is a spontaneous report from a contactable Nurse (patient). A 52-years-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 20Jan2021 10:00 (Batch/Lot Number: EL0140) (at the age of 52-years-old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included hypertension from an unknown date, Known allergies: Flu Shot, Raw egg. The patient did not receive other vaccine in four weeks. The patient did not get covid prior vaccination. Concomitant medications in two weeks included metoprolol; losartan; minocycline; bupropion hydrochloride (WELLBUTRIN) and colecalciferol (D3) all taken for an unspecified indication, start and stop date were not reported. On 20Jan2021 13:00, approximately 4 hours post vaccine the patient developed difficulty swallowing, lightheaded, she went home but ended up in ER with anaphylaxis treated with Epinephrine, solumedrol and benadryl. She was discharged that evening from the ER, symptoms resolved. The same symptoms started the next day on 21Jan2021 around 11am, this time symptoms were much quicker onset, she left work for ER and had totally obstructed airway and stridor, inability to talk. She was hospitalized after ER treatment and was discharged the next day on 22Jan2021, early afternoon. She was advised not to get the 2nd vaccine, which she had not. The patient was hospitalized for the events from 21Jan2021 to 22Jan2021. The adverse events resulted in Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event). Therapeutic measures were taken as a result of all the events included Epinephrine, Solumedrol, Diphenhydramine, zofran. The patient did not get covid tested post vaccination. The outcome of the events was resolved in 2021.; Sender's Comments: Based on the available information in the case, the causal association between the events, dysphagia, dizziness, anaphylactic reaction, obstructive airway disorder, stridor, speech disorder 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 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: METOPROLOL; LOSARTAN; MINOCYCLINE; WELLBUTRIN; D3

Current Illness:

ID: 1657913
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/31/2021
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: Myocarditis; This is a spontaneous report from a contactable consumer (reported for her husband). The case was for the husband. A male patient of an unspecified age received 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 number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced myocarditis. The clinical course was as follows: the reporter husband who is stuck getting this stupid thing that could probably kill him because he was a man and men who are 40 down to 17 are getting myocarditis and you people didn't seem to care about that. This case assessed as serious (life threatening and medically significant). The outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1657915
Sex: U
Age:
State:

Vax Date: 08/24/2021
Onset Date: 08/01/2021
Rec V Date: 08/31/2021
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: The patient felt like death. The patient literally felt like dying.; Anaphylactic shock; whole body was in the seizure; stomach felt like bonfire; lungs, back, shoulder blade, stomach and legs hurt; lungs, back, shoulder blade, stomach and legs hurt; lungs, back, shoulder blade, stomach and legs hurt; lungs, back, shoulder blade, stomach and legs hurt; legs hurt; angry; This is a spontaneous report from a non-contactable consumer (patient self). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration on 24Aug2021 (Batch/Lot number was not reported) at the age of unknown as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 on an unknown date at the age of unknown as single dose for COVID-19 immunization. The patient was angry in Aug2021 because the last night (24Aug2021) he/she was in an anaphylactic shock after taking second Pfizer jab. The stomach felt like bonfire on 24Aug2021. The patient felt like death. The patient literally felt like dying. The patient called doctor. And a bunch of other conditions. The vaccine destroyed the whole body. It was not the shock. It was lungs, back, shoulder blade, stomach and legs hurt on 24Aug2021. The whole body was in the seizure on 24Aug2021. Outcome of the events was unknown. No Follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am