VAERS 2021 Database www.vaers.hhs.gov

Main Page | All 2021 Deaths | Videos
VAERS Updated: 10/01/2021
** VAERS DATABASE Last updated: October 1, 2021**
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Manufacturers

Total Manufacturer

Incidents per State

State Total
63,479
AK1,562
AL4,914
AR3,110
AS44
AZ12,730
CA54,886
CO10,464
CT7,347
DC1,568
DE1,561
FL33,514
FM3
GA12,508
GU74
HI2,078
IA4,130
ID2,361
IL18,091
IN22,023
KS4,061
KY6,276
LA4,395
MA13,121
MD11,272
ME2,858
MH8
MI16,697
MN10,689
MO8,360
MP30
MS2,487
MT2,035
NC14,437
ND1,184
NE2,562
NH2,717
NJ16,033
NM3,532
NV3,784
NY30,921
OH17,029
OK5,673
OR7,479
PA21,111
PR1,959
QM2
RI1,833
SC5,601
SD1,087
TN8,048
TX31,896
UT3,791
VA13,180
VI48
VT1,592
WA13,026
WI9,856
WV2,120
WY754
XB5
XL1
XV2

ID: 1320228
Sex: F
Age: 35
State: IN

Vax Date: 05/13/2021
Onset Date: 05/13/2021
Rec V Date: 05/15/2021
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Allergies: N/a

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Symptoms: Sore throat, fever, chills, painful body aches

Other Meds: N/a

Current Illness: N/a

ID: 1320229
Sex: F
Age:
State: IL

Vax Date: 04/04/2021
Onset Date: 04/05/2021
Rec V Date: 05/15/2021
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Symptoms: Fever above 105 degrees for 5 days; Enlarged lymph nodes on left side of neck; tremors; causing difficulties breathing; pushing on esophagus; This is a spontaneous report from a contactable consumer (patient). A 27-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number was unknown and expiry was not reported), via an unspecified route of administration, in Left arm on 04Apr2021 at 13:00 (at the age of 27-years-old) at 1st dose single for COVID-19 immunization. Medical history included environmental allergies and Hashimoto's. Concomitant medication included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) in two weeks of vaccination. The patient previously took Ceclor and experienced allergies. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination has not been tested for COVID-19. Patient was not pregnant at the time of vaccination. The patient had fever, above 105 degrees for 5 days and unable to reduce with Tylenol, causing tremors; had enlarged lymph nodes on left side of neck causing difficulties breathing and pushing on esophagus as per ER physician on 05Apr2021 at 12:00 after the first dose. The events resulted in emergency room/department or urgent care (2 visits to ER needed in first 5 days following vaccine). Residual issues remained. Treatment was given for the events. The outcome of the event fever was recovered with sequel on 10Apr2021 while the other events (enlarged lymph nodes on left side of neck causing difficulties breathing and pushing on esophagus) was recovered with sequel in Apr2021. The event tremor was recovered in Apr2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained

Other Meds: ADDERALL

Current Illness:

ID: 1320230
Sex: F
Age: 42
State: CA

Vax Date: 04/21/2021
Onset Date: 04/21/2021
Rec V Date: 05/15/2021
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Symptoms: Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Additional Details: Follow up report from the first VAERS reported, regarding patient reporting redness from deltoid to elbow. Called patient on 04/29/2021 patient indicated that she has taken Bendryl at night and there was imporvement. Todays follow up call 05/14/2021 patient indicated a few days after the bendaryl, all symptoms had resolved. Currently patient indicated that there is no longer a redness from deltoid to the elbow.

Other Meds:

Current Illness:

ID: 1320231
Sex: F
Age: 28
State: VA

Vax Date: 05/12/2021
Onset Date: 05/13/2021
Rec V Date: 05/15/2021
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Allergies: Latex

Symptom List:

Symptoms: Intense migraine, fever, body aches 12 hours after injection. 25 hours after injection I had swollen lymph nodes in collarbone & armpit & minor migraine. Still have headache 3 days after injection.

Other Meds: None

Current Illness: None

ID: 1320232
Sex: F
Age:
State: NC

Vax Date: 02/15/2021
Onset Date: 02/19/2021
Rec V Date: 05/15/2021
Hospital: Y

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Symptoms: she had a stroke; ischemic stroke; This is a spontaneous report from a contactable consumer (Patient, self-reported). A 67-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EN6201), dose 2 via an unspecified route of administration, administered in Arm Left on 15Feb2021 11:00AM, as 2ND DOSE, SINGLE for covid-19 immunisation. Medical history included, allergic to bees and patient says there are members of her extended family that had strokes but they were almost 100 years old when they had them. her uncle died in October around Thanksgiving and he was 3 months shy of 100. She says they checked her heart and she was fine. Patient did not receive other vaccine in four weeks of vaccination. Concomitant medication's included levothyroxine sodium 50 mg once a day patient has been taking this for probably 5 years for inactive thyroid and General multivitamin for general health, patient says it is recommended by her general practice physician and she has been taking this for maybe 8 years, she guesses. Patient says she had an ischemic stroke 5 days after the second COVID vaccination. She says she is calling to see if there are any records of that happing to other people. She says she has to leave the call in 25 minutes. Patient says she had a stroke then went to the Emergency Room. For the outcome of the ischemic stroke she says there may be some things that she doesn't know. She says her doctor said she was ok and she can go back to what she was doing. Patient says the first shot says BioNTech and the second one just says Pfizer. She says the first one is a sticker and the second one is hand written. Second dose was on 15FEB2021, lot number EN6 then 2 or Z, she says she assumes it is a 2 based on the other lot number, then she thinks 01. For indication patient says she is all for the vaccinations, she thinks it's important to get the vaccine. She says she is the daughter of a physician. She says she is not scared of the vaccine, she believes in it. The patient previously received first dose of (BNT162B2), via an unspecified route of administration, administered in Arm Left, on 25Jan2021 11:00 PM (Batch/Lot Number: EL3247) as 1ST DOSE, SINGLE for covid-19 immunisation. On 19Feb2021 (probably late morning), the patient experienced ischemic stroke and on unspecified date of 2021 she had a stroke. The patient was hospitalized for the events from 19Feb2021 to 21Feb2021. The patient underwent lab tests and procedures which included echocardiogram: unknown, her echocardiogram was fine, magnetic resonance imaging: unknown and ultrasound scan: unknown on 2021. Outcome of the events was unknown. Follow up (PRD/SRD 04May2021): This is a Follow-up spontaneous report from a contactable consumer. Follow up(10May2021): This is a Spontaneous report from a Medical information Team. This consumer(patient) reported that: Follow-up attempts are completed. No further information is expected

Other Meds: LEVOTHYROXINE SODIUM

Current Illness:

ID: 1320233
Sex: U
Age:
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Rec V Date: 05/15/2021
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Symptoms: Now has COVID; Now has COVID; This is a spontaneous report from a contactable consumer, the patient. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as a single dose for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient now has COVID on an unspecified date after first dose. The patient underwent lab tests and procedures which included SARS-COV-2 test: positive on an unknown date. The clinical outcome of the event patient now has COVID was unknown. The batch/lot numbers for the vaccine, PFIZER-BIONTECH COVID-19 MRNA VACCINE, were not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1320234
Sex: F
Age:
State:

Vax Date: 04/01/2021
Onset Date: 04/01/2021
Rec V Date: 05/15/2021
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Symptoms: pretty significant rash all over her body that look like underlying diffused erythema with a multiforma look.; This is a spontaneous report from a contactable physician. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on an unspecified date in Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for covid-19 immunisation and the patient experienced a few small red spots on her body. The patient experienced pretty significant rash all over her body that look like underlying diffused erythema with a multiforma look on an unspecified date. The outcome of the event was unknown. The 2nd dose, which she received last week (in Apr2021), blew her up with a pretty significant rash all over her body that look like underlying diffused erythema with a multiforma look. She mentioned that she was already given steroids at a fairly moderate amount without improvement. She is considering on giving her a high dose of steroids. She is asking if there have been any reports on this and for any input on the situation. Response: Was going to offer information on the reports of allergic reactions but caller clarified that what happened to the patient was not histamine-mediated. Mentioned to caller that there was no specific data on non-histamine-mediated skin reactions. Offered data on use with immunosuppressive therapy to address higher steroid dose issue but caller mentioned that it will not be helpful. The outcome of the event was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.; Sender's Comments: Considering the plausible temporal association, the reasonable possibility that the event reported as ' Diffused erythema with a multiforma look' (Erythema multiforme) is related to BNT162B2 vaccine cannot be excluded. No alternative explanations were reported. 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 agency, as appropriate.

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Current Illness:

Date Died:

ID: 1320235
Sex: M
Age:
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Rec V Date: 05/15/2021
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Symptoms: died from Pfizer vaccine of anaphylactic reaction; This is a spontaneous report from a non-contactable consumer. A 60-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as unknown, single for Covid-19 immunisation. Medical history included hypersensitivity (there was something he was allergic to it's what is used in contrast imaging). Concomitant medications were not reported. The patient had an anaphylactic reaction to the vaccination and through the anaphylactic reaction he passed away. The patient died on an unspecified date. It was not reported if an autopsy was performed. Information about lot/batch number has been requested.; Reported Cause(s) of Death: Anaphylactic reaction

Other Meds:

Current Illness:

ID: 1320236
Sex: M
Age:
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Rec V Date: 05/15/2021
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Symptoms: had got his first Pfizer Vaccine this past Friday and then he ended up testing positive on Tuesday for COVID.; had got his first Pfizer Vaccine this past Friday and then he ended up testing positive on Tuesday for COVID.; This is a spontaneous report from a contactable consumer. This consumer (patient father) reported for a patient that: An unspecified age of male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown, Expiry Date: Unknown), via an unspecified route of administration, administered on unknown date as a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On unknown date, the patient got his first Pfizer Vaccine this past Friday and then he ended up testing positive on Tuesday for COVID. He had scheduled appointment on May 21st to get his second dose. Since the vaccination, the patient had been tested for COVID-19 with SARS-CoV-2 test and resulted positive on unknown date. The outcome of the events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1320237
Sex: F
Age:
State: CA

Vax Date: 03/01/2021
Onset Date: 03/01/2021
Rec V Date: 05/15/2021
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Symptoms: heart arrhythmia; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on Mar2021 (Lot Number: ER8732) (at the age of 43-year-old) as single dose for COVID-19 immunisation. The patient medical history was not reported. Concomitant medication included bupropion hydrochloride (WELLBUTRIN XL) taken for an unspecified indication, start and stop date were not reported. The patient experienced heart arrhythmia on Mar2021. The patient outcome of the event was unknown.

Other Meds: WELLBUTRIN XL

Current Illness:

ID: 1320238
Sex: F
Age:
State: MA

Vax Date: 04/14/2021
Onset Date: 04/14/2021
Rec V Date: 05/15/2021
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Symptoms: muscle is tearing away from my arm. I feel like I injured it pretty badly; muscle is tearing away from my arm. I feel like I injured it pretty badly. Burning, sharp, achy pain; Started like a pulled muscle feeling; My arm feels really heavy and painful; My arm feels really heavy and painful; I found where the pain is coming from and its right where the injection site was; muscle is tearing away from my arm; aches and pains on left side of body; Extremely tired; This is a spontaneous report from a contactable consumer (patient). A 34-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: er 8734, expiration date: Jul2021) at the age of 34-years-old, via an unspecified route of administration in left arm on 14Apr2021 at 13:00 at 1st dose, single for COVID-19 immunisation. Medical history included being immunocompromised and rheumatoid arthritis. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included cholestyramine. She has not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took aspirin. The patient received the vaccine at a pharmacy and on the day of the shot (14Apr2021), she experienced aches and pains on left side of body and she was extremely tired for 2 days. On 29Apr2021 at 19:00, 2 weeks and 1 day after first shot, the patient felt like her muscle was tearing away from her arm and felt like she injured it pretty badly. There was a burning, sharp, achy pain which was much worse than that achy feeling after the shot. The onset was very sudden. It started like a pulled muscle feeling. Now, she could not find a position that did not hurt constantly. There were tons of pain when she moves it and the pain seemed to worsen when she leaves it. Her arm felt really heavy and painful down at her side. She thought it was the front of her arm/shoulder, then maybe the back; but she found where the pain was coming from and its right where the injection site was. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the event "extremely tired" was recovered on 16Apr2021 and not recovered for all other events.

Other Meds: CHOLESTYRAMINE

Current Illness:

ID: 1320239
Sex: F
Age:
State: CA

Vax Date: 04/17/2021
Onset Date: 04/01/2021
Rec V Date: 05/15/2021
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Symptoms: heart arrhythmia; hypokalemic, low in potassium; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration, administered in Arm Left on 17Apr2021 at age of 43-year-old (Lot Number: EW0162) at single dose for COVID-19 immunization. The patient's medical history was not reported. Concomitant medication included bupropion hydrochloride (WELLBUTRIN XL). The patient previously took first dose of bnt162b on 26Mar2021 (lot number: ER8732) for COVID-19 immunization and experienced heart arrhythmia. After the second vaccine in Apr2021, it exponentially increased to the point that she was in the emergency room (ER), the patient was laying flat on the floor and as soon as I get out the arrhythmia started. On an unspecified date in Apr2021 night they were testing and it was arrhythmia. She didn't know if it is related to the vaccine or not but she did not have arrhythmia beforehand and a friend of the patient mentioned that she should call it in. She underwent many lab tests in Apr2021 because she was in the ER. The lab results showed that she was hypokalemic, low in potassium other then that everything came back fairly normal. The patient was on treatment for arrhythmia on 29Apr2021. The outcome of the events was unknown.

Other Meds: WELLBUTRIN XL

Current Illness:

ID: 1320240
Sex: F
Age:
State: NC

Vax Date:
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Rec V Date: 05/15/2021
Hospital: Y

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Symptoms: fever; Bad headache; Chills; Nausea; This is a spontaneous report from a Pfizer-sponsored program COVAX SUPPORT received from a contactable consumer (Grandmother). A female patient of unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown) on an unspecified date at single dose via an unspecified route of administration for COVID-19 immunization. Relevant medical history and concomitant medications were not reported. The patient experienced bad headache, chills, fever and nausea on an unspecified date after vaccination. It was informed that she was in the hospital receiving treatment. At the time of the reporting the patient had not yet recovered from reported events.

Other Meds:

Current Illness:

ID: 1320241
Sex: F
Age:
State: CA

Vax Date: 04/20/2021
Onset Date: 04/20/2021
Rec V Date: 05/15/2021
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Symptoms: sudden feeling of being very unwell that felt like potential heart attack symptoms; sudden feeling of being very unwell that felt like potential heart attack symptoms; extreme fatigue and sudden shortness of breath/shortness of breath while walking; chest tightness; nausea; headache; Flu-like symptoms and greater fatigue; unusual heart PVC's started and worsened over the next 6 days; unusual heart PVC's started and worsened over the next 6 days; feeling very tired that was not cured by sleeping; moderate muscle pain and aches; moderate muscle pain and aches; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received the 2nd dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration in arm left, on 20Apr2021 at 08:30 AM (Lot Number: ER8732), as single dose, for COVID-19 immunisation. Medical history included atrial fibrillation corrected by cardiac ablation, drug hypersensitivity (all sulfur related drugs). Concomitant medication included alprazolam (unknown manufacturer). Previously the patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech, lot# ER8732) for COVID-19 immunisation, at single dose in arm left, on 30Mar2021 at 08:15 AM. The patient experienced sudden feeling of being very unwell that felt like potential heart attack symptoms (medically significant) on 27Apr2021 with outcome of recovering, moderate muscle pain and aches (non-serious) on 20Apr2021 with outcome of recovering, unusual heart pvc's started and worsened over the next 6 days (non-serious) on 22Apr2021 with outcome of recovering, feeling very tired that was not cured by sleeping (non-serious) on 22Apr2021 with outcome of recovering, flu-like symptoms and greater fatigue (non-serious) on 26Apr2021 with outcome of recovering, extreme fatigue and sudden shortness of breath/shortness of breath while walking (non-serious) on 27Apr2021 with outcome of recovering, chest tightness (non-serious) on 27Apr2021 with outcome of recovering, nausea (non-serious) on 27Apr2021 with outcome of recovering, headache (non-serious) on 27Apr2021 with outcome of recovering. The events required emergency room visit. On unknown date the patient underwent lab tests and procedures which included blood test: unknown result, chest x-ray: unknown result, electrocardiogram: unknown result. Therapeutic measures were taken as a result of the events. Clinical course: beginning later the same day after receiving 2nd vaccine dose and continuing for 2 days, moderate muscle pain and aches. On 22Apr2021 unusual heart PVC's started and worsened over the next 6 days. Also beginning at that time, feeling very tired that was not cured by sleeping. On 26Apr2021, began feeling flu-like symptoms and greater fatigue. On 27Apr2021, extreme fatigue and sudden shortness of breath while walking from my car to the office, accompanied by chest tightness, nausea, headache, intense, and sudden feeling of being very unwell that felt like potential heart attack symptoms. These continued throughout the day. On 28Apr2021, continued fatigue and all other symptoms including the heart PVC's. All symptoms began to lessen near the end of the day. On 29Apr2021, further lessening of all symptoms. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.

Other Meds: ALPRAZOLAM

Current Illness:

ID: 1320242
Sex: F
Age:
State: NV

Vax Date: 04/06/2021
Onset Date: 04/16/2021
Rec V Date: 05/15/2021
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Symptoms: deathly ill after the vaccine; blood clots in stool; This is a spontaneous report from a contactable pharmacist. An adult female patient received COVID-19 vaccine (UNSPECIFIED TRADE NAME), via an unspecified route of administration on 06Apr2021 (Batch/Lot Number: Unknown) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store. The patient experienced deathly ill after the vaccine and blood clots in stool on 16Apr2021 with outcome of recovering. Patient stated they had blood clots in stool 2 weeks after the vaccination but was deathly ill after the vaccine. The adverse event result in Doctor or other healthcare professional office/clinic visit. Information on the lot/batch number has been requested.; Sender's Comments: Based on the temporal relationship, the association between the events "deathly ill" and "blood clots in stool" with COVID-19 vaccine can not be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Other Meds:

Current Illness:

ID: 1320243
Sex: F
Age:
State: GA

Vax Date: 04/15/2021
Onset Date: 04/15/2021
Rec V Date: 05/15/2021
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Symptoms: Severe muscle soreness (paralyzing); Severe muscle soreness (paralyzing); soreness in tissue and bones; soreness in tissue and bones; unable to walk straight; numbness in hands, arms, and feet.; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm left on 15Apr2021 11:00 (Batch/Lot Number: EW0162) at the age of 49 years, as 0.3 ml single for covid-19 immunisation. Previously the patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot: EN6207, on 25Mar2021 at 11:00 AM at 0.3 ml single in left arm. Medical history included calcium deposits and mitral valve prolapse, from an unknown date and unknown if ongoing. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's concomitant medications were not reported. On 15Apr2021 at 18:00 the patient experienced severe muscle soreness (paralyzing), soreness in tissue and bones, unable to walk straight, numbness in hands, arms, and feet (severe symptoms as such for 4 days). The outcome of the events was resolving.

Other Meds:

Current Illness:

ID: 1320244
Sex: M
Age:
State: IL

Vax Date: 03/12/2021
Onset Date: 03/01/2021
Rec V Date: 05/15/2021
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Symptoms: Rheumatoid arthritis flare up; Pain in joint involving hand; Injection site papule; Bruising; Sprain; Dizziness; Loss of balance; Sickness; Vision decreased / Bilateral abnormal vision; Blurring of eyes; fatigue; bumps from the injector pen; Pain in extremity / ARM PAIN; This is a solicited report from non-Pfizer sponsored program received from a contactable physician based upon information received by Pfizer from company (21K-163-3820459-00). A 59-year-old adult make received the first dose of intramuscular BNT162b2 (solution for injection; Lot EL3248 expiry information not provided) as a single dose on 12Mar2021 (at 59-years-old) for COVID-19 immunisation. The patient also started to receive subcutaneous adalimumab (HUMIRA, unspecified formulation) 40mg at an unspecified frequency from an unspecified date for arthritis. Relevant medical history included rheumatoid arthritis, inflammation, high blood pressure, red face, red skin, used cane for walking because he could not walk (before adalimumab), and a loss of hearing in the left ear (one month prior to starting adalimumab). It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Concomitant medications included sulfasalazine for inflammation; lisinopril for high blood pressure; and another [unspecified] medication for inflammation. The patient previously received treatment for inflammation with steroids which were not good enough. On an unspecified date in Mar2021, after receiving the vaccine, the patient developed arm pain, it made him tired, he had dizziness, fatigue almost every time, and a loss of balance. The patient had bumps from the injector pen/ Injection site papule, Pain in joint involving hand, bruising, sprain, and sickness. On an unspecified date in Apr2021 the patent experienced bilateral abnormal vision/vision decreased and blurring of eyes. On 09Apr2021, patient received second dose BNT162b2 (solution for injection; Lot EL3302 expiry information not provided) as a single dose. The action taken with adalimumab was unknown. The outcome of the event Sickness was recovered on an unspecified date. The outcome of the events bilateral abnormal vision/vision decreased, blurring of eyes, and fatigue, was not recovered. The outcome of the events pain in extremity / arm pain, bruising, sprain, dizziness, loss of balance, was recovering. The outcome of the events Pain in joint involving hand, Injection site papule, and bumps from the injector pen was unknown. The reporter's assessment of the causal relationship of the event 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. No follow-up attempts possible. No further information expected.; Sender's Comments: Based on available information, a possible contributory role of subject product, BNT162B2 vaccine cannot be excluded for the reported events of Injection site papule, Pain in joint involving hand, bruising, dizziness, loss of balance, fatigue and sickness, based on temporal relationship. Based on the information provided by the reporter, it appears unlikely that the subject product contributed to the RA flare and other reported events, which likely represent intercurrent medical conditions. There is very limited information provided in this report. This case will be reassessed upon receipt of follow-up information. 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: SULFASALAZINE; LISINOPRIL

Current Illness:

ID: 1320245
Sex: F
Age:
State: NY

Vax Date: 02/23/2021
Onset Date: 04/21/2021
Rec V Date: 05/15/2021
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Symptoms: Nasal Swab covid was tested post vaccination; Nasal Swab covid was tested post vaccination; This is a spontaneous report from a contactable consumer (patient). A 64-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Right on 23Feb2021 14:00 (Lot Number: EL9262) as single dose, dose 1 via an unspecified route of administration, administered in Arm Left in Jan2021 14:00 (Lot Number: GL0140) as single dose for covid-19 immunisation.Medical history included acute sinusitis. The patient did not have known allergies.The patient's concomitant medications included unspecified products within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have COVID prior vaccination. Nasal Swab covid test was tested post vaccination on 21Apr2021 and result was positive.It was also reported that "TESTED POSITIVE FOR COVID-19 ON 23Apr2021" and "event start date 19Apr2021 12:00 PM". The event resulted in Doctor or other healthcare professional office/clinic visit, Disability or permanent damage. The event outcome was resolving.

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Current Illness:

ID: 1320246
Sex: F
Age:
State: FL

Vax Date: 02/03/2021
Onset Date: 02/01/2021
Rec V Date: 05/15/2021
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Symptoms: pain all over body; Chest pain; Leg pain; severe pain on her neck, she couldn't lift her head; Monday morning she couldn't get out of bed.; the red blood cell count was low; the hemoglobin was low; having to use a walker; anxiety; her heart starts racing; has been taking steroids and her weight has shot up like crazy now she is 120 lbs; The platelets which is the ones that do the clotting, normal high is 200 and hers were higher than normal at 760; This is a spontaneous report from a contactable consumer (patient) via Pfizer-sponsored program. An 80-year-old (currently she just turned 81-year-old) female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in arm left on 03Feb2021 3:20 PM (Batch/Lot Number: EN5318) as single dose at the age of 80-year-old for covid-19 immunisation, as care provider for her husband, administered at a COVID vaccine clinic setup. Medical history, family medical history and concomitant medications were none. She has been very healthy. Before BNT162B2 first dose, In Jan2021, 2 weeks prior BNT162B2, she got the second dose of shingles shot (VARICELLA VACCINE) for immunization with no adverse effect. No adverse effect occurred following prior vaccinations. No other history of all previous immunization with BNT162B2. No additional vaccines administered on same date of BNT162B2. In Feb2021 she experienced pain all over body with outcome of recovered, chest pain with outcome of recovered, leg pain with outcome of recovered, severe pain on her neck. In 2021 the patient experienced the platelets which is the ones that do the clotting, normal high is 200 and hers were higher than normal at 760, she couldn't lift her head, Monday morning she couldn't get out of bed, the red blood cell count was low, the hemoglobin was low, having to use a walker, anxiety, her heart starts racing, has been taking steroids and her weight has shot up like crazy now she is 120 lbs. The patient underwent lab tests and procedures which included in 2021: haemoglobin: low, platelet count: 760 higher than normal at 760, red blood cell count: low , weight: 120lbs. Therapeutic measures were taken as a result of events. The course of events was as follows: After she got the first dose she had some adverse reactions in 2021: she had pain all over body, chest pain, leg pain, severe pain on her neck, that she couldn't lift her head. She has seen some specialists to seek assistance, she has seen a hematologist, and a rheumatologist. She has been on steroids and she was not yet done with the second dose of the Pfizer COVID 19 vaccine. Her doctor was very aware. When this started 3 months before, she 110 lbs but she has been taking steroids and her weight has shot up like crazy now she is 120 lbs, she told her doctor that she had no more fat clothes she will have to get off of the steroids, they blame everything on steroids. She said nothing else is relevant she was fine, in fact she was dancing the weekend before, that Saturday night she went to a Portuguese evening and was learning to do their dances and Monday morning she couldn't get out of bed. She refused to go to Emergency Room for the events. She has seen her doctor who requested she see a hematologist and a rheumatologist because she was having pain in her legs, she was having to use a walker. The hematologist found that her blood was out of whack. The platelets which was the ones that do the clotting, normal high is 200 and hers were higher than normal at 760, higher than what they call the high normal. The events pain all over body she had chest pain, leg pain, severe pain on her neck may have began a week after the vaccine in Feb2021. The pain was not ongoing, it was gone. They gave her massive doses of steroids she was taking 15 mg of steroids and right now they are lowering it. She had not the pain now but it was worse than childbirth. She has recovered completely from the pain, she felt fine now she has to wait until they take the steroids away again. She stated a lot of the blood, the red blood cell count was low, the hemoglobin was low, everything was low except for the platelets. So they told her to wait. She stated they blame everything on the steroids. Her anxiety started and her heart started racing, they said it was steroids, she was hungry they say it was steroids, she told the doctor she was gaining weight, they say it was steroids. No further information provided. She went to physician on 28Apr2021, the blood hematologist and they say it seemed that most blood work was back to almost normal everything was going down, the treatment she was receiving was working, the platelets were going down. She confirmed she had to wait to come off the steroids to get the second dose and she asked the doctor if she could get the second dose, she still wanted to get it but they told her she has to wait until she is completely off the steroids. The outcome of pain all over body, chest pain, leg pain, severe pain on her neck, she couldn't lift her head was recovered in 2021, of platelets which is the ones that do the clotting, normal high is 200 and hers were higher than normal at 760 was recovering, of she couldn't get out of bed, the red blood cell count was low, the hemoglobin was low, having to use a walker, anxiety, her heart starts racing, has been taking steroids and her weight has shot up like crazy now she is 120 lbs was unknown.

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Current Illness:

ID: 1320247
Sex: F
Age:
State: CA

Vax Date: 04/27/2021
Onset Date: 04/28/2021
Rec V Date: 05/15/2021
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Symptoms: passed out; Severe abdominal pain; arm was very sore from the injection site; hit my head very hard; I felt the need to vomit; woozy; bruised; This is a spontaneous report from a contactable consumer reporting for herself. A 33-years-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 27Apr2021 (Batch/Lot Number: EW0165) as single dose for covid-19 immunisation . The patient medical history and concomitant medications were not reported. The patient passed out on 28Apr2021 02:30 with outcome of recovering , had severe abdominal pain on 28Apr2021 02:30 with outcome of recovering , arm was very sore from the injection site on 28Apr2021 02:30 with outcome of recovering , hit my head very hard on 28Apr2021 with outcome of recovering , i felt the need to vomit on 28Apr2021 with outcome of recovering , woozy on 28Apr2021 with outcome of recovering , bruised on 28Apr2021 with outcome of recovering. Loss of consciousness was considered an Important Medical Event. Course of the event: The patient stated: At 2:20 am I woke up with severe abdominal pain, and my arm was very sore from the injection site. I got up to take Tylenol since i hadn't taken any yet. While I was trying to read the label I got very dizzy and I tried to walk back to my bed and I passed out onto the floor. When I woke up I felt like I had hit my head very hard, I slowly went back to my bedroom and passed out again and my husband found me unconscious And called 911. When I woke up I felt the need to vomit and have bowl movements so he took me to the bathroom. When the paramedics came I was conscious but very nauseous and woozy. Now I am bruised all over, the bridge of my nose where I hit my face, and knees and elbows". Follow up information has been requested.

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Current Illness:

ID: 1320248
Sex: F
Age:
State: NJ

Vax Date: 03/20/2021
Onset Date: 03/29/2021
Rec V Date: 05/15/2021
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Symptoms: fainting; POTS; Dysautonomia; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient (non-pregnant at time of vaccination) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration administered in the left arm on 20Mar2021 (Lot number: EP7534) as single dose for COVID-19 immunisation. Medical history included hypertension and depression, allergies to penicillin. Concomitant medications included fluoxetine hydrochloride (PROZAC), bupropion hydrochloride (WELLBUTRIN), labetalol. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration administered in the left arm on 02Mar2021 (Lot number: EN6205) as single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient did not diagnose with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Occurred on 29Mar2021, patient experienced dysautonomia: fainting and POTS. The adverse events resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The outcome of events was not recovered.

Other Meds: PROZAC; WELLBUTRIN; LABETALOL

Current Illness:

ID: 1320249
Sex: M
Age:
State: TX

Vax Date: 04/12/2021
Onset Date: 04/13/2021
Rec V Date: 05/15/2021
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Symptoms: migraines; dizziness off and on; Severe chronic headaches; fatigue; little lethargic/feeling lethargic; sensitivity to light; balance is off/was going left and right trying to stay in balance; hypersomnia; not been able to work or drive since being vaccinated; vision impairment; This is a spontaneous report from contactable other HCP. A 37-years-old (current age of 37-38 when the reported events began) male patient received first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Formulation: Solution for injection, Batch/Lot Number: EW0I58; expiration: not reported), intramuscular, administered in arm right on 12Apr2021 16:00 as single for Covid-19 immunisation/covid precautions, not wanting to get covid at pharmacy or drug store. The patient medical history was none. Concomitant medication(s) included vortioxetine hydrobromide (TRINTELLIX; received within 2 weeks of vaccination). No additional vaccines administered on same date of the Pfizer suspect, no other prior vaccinations (within 4 weeks prior to the COVID vaccine), no relevant family medical history. The patient was not diagnosed with COVID-19 prior to vaccination and since the vaccination. No other products and no investigation assessment. On 13Apr2021, the patient had headache, sensitivity to light, was feeling lethargic, balance was off, fatigue, and hypersomnia. The headache and vision impairment (start date: 13Apr2021) were ongoing and began the very next day after the 1st dose of the Pfizer COVID Vaccine and at first the headache was very severe and now was just different and his headache kind of moved around and was always constant and persistent and got better and then boom it came back. The patient had been a little lethargic (start date: 13Apr2021) and that began the same day as the headache and vision impairment which was the very next day after the 1st dose of the vaccine. Dizziness (start date: 13Apr2021) began the very next day after the vaccine and was almost like an imbalance of whenever he was walking, he noticed he was kind of not walking a straight line almost and was going left and right trying to stay in balance (start date: 13Apr2021) and this was a little bit better. After the 1st dose the patient was getting a little concerned right now because he got the vaccine about three weeks ago and ever since he had been having severe chronic headaches and vision impairment that was ongoing and began the very next day after the 1st dose of the vaccine; the patient was a little lethargic, kind of had dizziness off and on and went to his PCP, had an MRI, and was sent to a neurologist. The patient was taking Advil, Motrin and Tylenol that were not helping his migraines (start date: unspecified) and nothing from the bunch of medications the neurologist gave him were working to help and stated Nurtec ODT (lot 3990840, expiry date Oct2022 and NDC 72618-3001-1) 75mg once daily and Nortriptyline 10mg (orange pharmacy bottle with no lot, expiry date or NDC) supposed to be one capsule the 1st week and then two capsules after that by mouth. Motrin, Advil and Tylenol (no lot numbers, expiry dates or UPC numbers to provide because he ran out of those and threw the bottles away when he was done and has been meaning to get more but has not). Unspecified medicines, Toradol IV were given as therapeutic measure. The patient was not sure about the dates regarding his MRI (MRI was maybe a week and a half after this all started and then maybe a week after that he saw the neurologist). Headaches kept him up to night also and the patient had been to neurology, ophthalmology consultation, and received an MRI. The adverse events resulted in disability or permanent. The patient had not been able to work or drive since being vaccinated. The patient had no further treatment and had not gone to the ER but was under advisement that he was to go to the ER, but he could not afford to go to the ER. The patient had not had the 2nd dose of the Pfizer COVID Vaccine yet and his PCP and neurologist both agree that he would not be getting the 2nd dose of the vaccine due to the reactions he has had. The patient was calling to see if Pfizer offered help as he was without insurance and his PCP said he might need to send the patient to the hospital which might be out of the question and he was calling to see if Pfizer could help him with anything as he has not been at work for three weeks and the headache was not going away. The patient underwent lab tests and procedures which included magnetic resonance imaging with no results on unspecified date and nasal swab (sars-cov-2 test) was negative on 15Apr2021. The outcome for little lethargic/feeling lethargic was not recovered, severe chronic headaches was not recovered, sensitivity to light was not recovered, balance is off was not recovered, fatigue was not recovered, hypersomnia was not recovered, not been able to work or drive since being vaccinated was not recovered, vision impairment was not recovered, kind of has dizziness off and on was recovering and for migraine was not recovered. Information on Lot/Batch number was available. Additional information has been requested; Sender's Comments: The events was considered related to suspect drug based on Compatable temporal association and known safety profile of the drug. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.

Other Meds: TRINTELLIX

Current Illness:

ID: 1320250
Sex: M
Age:
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Vax Date: 04/01/2021
Onset Date: 04/01/2021
Rec V Date: 05/15/2021
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Symptoms: Headache; positive COVID-19 test; positive COVID-19 test; This is a spontaneous report from a contactable consumer (patient). An 18-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on Apr2021 (Batch/Lot Number was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient reported that: "I got the vaccine on Sunday afternoon and I got the COVID test yesterday at the school and I got positive result". The patient experienced headache on 28Apr2021. The patient underwent lab tests and procedures which included COVID-19 test: positive on Apr2021. The patient outcome of headache was recovering and unknown for the other events. Information on the lot/batch number has been requested.

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ID: 1320251
Sex: M
Age:
State: CA

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Rec V Date: 05/15/2021
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Symptoms: blood clot; heart attack; This is a spontaneous report from a contactable consumer. This consumer reported for his father. A male patient of an unspecified age received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation . The patient medical history and concomitant medications were not reported. The patient experienced blood clot and had an heart attack on an unspecified date with outcome of unknown. Information on the lot/batch number has been requested.

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ID: 1320252
Sex: F
Age:
State: NY

Vax Date: 04/27/2021
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Rec V Date: 05/15/2021
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Symptoms: her sugar numbers are high; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot Number: EW0175), via an unspecified route of administration on 27Apr2021 as 1st dose, single for COVID-19 immunization. Medical history included diabetes (she is a diabetic), IUD (intrauterine contraception, 10 year IUD). The patient's concomitant medications were not reported. She got the first dose of the Pfizer covid 19 vaccine yesterday (27Apr2021). She has 10 year IUD in her, states it is not a hormonal one and she is asking if her IUD could affect anything. Reports her sugar numbers are high, she is a diabetic. She is wondering if the vaccine could affect her sugar. The outcome of the event was unknown.

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Current Illness:

ID: 1320253
Sex: F
Age:
State: AL

Vax Date: 04/26/2021
Onset Date: 04/27/2021
Rec V Date: 05/15/2021
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Symptoms: Itching; Tongue is numb and tingling; Tongue is numb and tingling; allergic reaction; at the injection site she broke out; rashes on both arms/saw other red dots appear; Rash; This is a spontaneous report from a contactable consumer.A 18-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 26Apr2021 18:00 (Batch/Lot Number: EW0153; Expiration Date: Jul2021) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced rash on 27Apr2021, itching on 28Apr2021, tongue is numb and tingling on 27Apr2021, allergic reaction on 27Apr2021, she thought it was acne at first, but at the injection site she broke out on 27Apr2021, rashes on both arms/saw other red dots appear on 27Apr2021. Clarified allergic reaction as: She thought it was acne at first, but at the injection site she broke out. She has rashes on both arms. Rash seems to be spreading. Really started to show on day two and day three. Hasn't taken anything for it. She tends to break out on her arms, that's just her own body, but she saw other red dots appear that hadn't been there on her arms. She was itching last night and that was new. Is not itching as of now. She went to the hospital and was told to take Benadryl. Clarified she went to the vaccination facility, which was the hospital, and she was asked what was going on. She was not a patient of the ER and was not admitted to the hospital. Forgot to mention her tongue has been numb and tingling for a couple of days. First noticed it when she had something cold, but has persisted even without drinking something cold. Started Tuesday, 27Apr2021, night. Wondering if that is a side effect. Read in the pamphlet it is part of an allergic reaction. Read that rash is a part of a severe reaction.Outcome of all events was not recovered. Therapeutic measures were taken as a result of all events.

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ID: 1320254
Sex: M
Age:
State: TX

Vax Date: 04/17/2021
Onset Date: 04/20/2021
Rec V Date: 05/15/2021
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Symptoms: Severe allergic reaction; all his back was red; pain; felt like his throat was getting really raspy/ felt like his throat was about to close; tried to drink water and couldn't even pass (swallow) it; body rash all over the body, it was itching and itching/ itching and itching, got the rash on arm escape, inside arm, belly, penis, inside legs, body in the back everywhere; This is a spontaneous report from a contactable consumer (patient) reported for himself that a 46-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0150) at the age of 46-years, via intramuscular in left arm on 17Apr2021 at single dose for COVID-19 immunisation. Medical history included enlarged prostate; gout; anxiety. Concomitant medications included medication for diet; prostate medication because his prostrated was enlarge; medication for gout and anxiety. Patient stated that he got injected with COVID-19 the Pfizer shot and they gave him like side effects, pain. He was experiencing one of the severe allergic reactions. The body rash all over the body, it was itching and itching. He didn't know what to take with it. He mean he called the health department, they told him to take diphenhydramine hydrochloride (BENADRYL) but he mean what can remove this bad rash all over the body. If he did what they need to give him because he spoke to a COVID-19 nurse and was told that no reverse on the vaccine. There was nothing you can take to reverse the effect. He stated that he took vaccine on 17Apr2021, and on 20Apr2021, after three days later, had broke down with rashes. When probed for ongoing of the side effects, patient stated that of the vaccine, yes, he was itching and itching, got the rash on his arm escape, inside his arm, belly, penis, inside legs, body in the back everywhere, all his back was red. He mentioned that his doctors told him to take diphenhydramine hydrochloride, it was over the counter for allergy. They said you have to take that but the doctor, the health department told him that didn't work, may be take the steroids shot but patient spoke to another doctor they told him that steroids shot was not recommended. As of 03May2021, patient stated that he went and got the first dose and 3 days later, he broke out in a rash. Then, on Friday, 30Apr2021, he felt like his throat was getting really raspy. He thought "well, let me get some water". He tried to drink water and couldn't even pass (swallow) it. He felt like his throat was about to close. He drove himself to the Emergency Room and was given a steroid shot. He confirmed he had rash and itchiness all over his body 3 days after receiving the first dose, clarifies starting on 20Apr2021. The patient was only seen in the ER and was not admitted into the hospital. He was given a steroid shot that was supposed to be for the feeling of his throat closing up and for any type of rashes and stuff like that. He confirmed he was also given an intravenous dose of diphenhydramine hydrochloride 50mg. However, he was still itchy. The patient underwent lab tests and procedures, which included weight was 260-270lbs. Blood work on 30Apr2021 was normal. Outcome of the events was unknown.

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ID: 1320255
Sex: M
Age:
State: MI

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Rec V Date: 05/15/2021
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Symptoms: had two seizures on the same day; epilepsy; This is a spontaneous report received from a non-contactable consumer reported for a 20-year-old male patient received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The medical history and concomitant medications were not reported. The patient had epilepsy. He had two seizures this week on the same day and he had not had a seizure in 1.5 years. The outcome of the events was unknown. Information on the lot/batch has been requested.

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Current Illness:

ID: 1320256
Sex: F
Age:
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Rec V Date: 05/15/2021
Hospital: Y

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Symptoms: pneumonia; a hard time breathing; coughing up dark yellow phlegm; coughing up dark yellow phlegm; This is a spontaneous report from a contactable consumer (patient's sister). A 67-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medication included tofacitinib citrate (XELJANZ XR), via an unspecified route of administration from Oct2020 to an unspecified date, at 11 mg for an unspecified indication. On an unspecified date the patient experienced pneumonia, had a hard time breathing and coughing up dark yellow phlegm and was admitted to the hospital. The patient was treated with antibiotics for pneumonia. The outcome of the events was unknown. No follow up attempts are possible. Information about Lot/batch number cannot be obtained.

Other Meds: XELJANZ XR

Current Illness:

ID: 1320257
Sex: F
Age:
State:

Vax Date: 04/18/2021
Onset Date: 04/27/2021
Rec V Date: 05/15/2021
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Symptoms: abscess on her pharynx; sore throat; This is a spontaneous report received from a contactable consumer (patient herself). A 21-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Formulation: solution for injection; Lot number and Expiration date: UNKNOWN), via an unspecified route of administration on 18Apr2021, as a single dose for COVID-19 vaccination. The patient's medical history and concomitant medications were not reported. Patient reported that a week later on 27Apr2021, she got a sore throat. Caller reported that she went to the doctor on 30Apr2021 and was tested negative for covid but was diagnosed with an abscess on her pharynx. Patient described it as a pouch full of puss. Patient reported that she was prescribed an antibiotic and steroids as treatment for events. Patient stated that her throat does not hurt anymore. Patient reported that she will go to an ENT on Friday to make sure it was completely gone. Patient asked if was is safe to take the second dose even if she was taking antibiotics and steroids. Patient stated her last dose of the steroid was today and she would only be on the antibiotic on Sunday. Patient inquired would there be a problem, and response was given. Drug Interactions. Patient also inquired if she can wait more than three weeks apart. The outcome of the events was resolved for sore throat and unknown for abscess on pharynx. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1320258
Sex: F
Age:
State: OH

Vax Date: 03/11/2021
Onset Date:
Rec V Date: 05/15/2021
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Symptoms: Diagnosed with UTI and was under the medication of antibiotics; This is a spontaneous report from a contactable consumer (patient) received from a Pfizer-sponsored program, COVAX Support. A female patient of unspecified age received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number and expiration date not reported), via an unspecified route of administration on 11Mar2021 (also reported as 12Mar2021) (at an unspecified age) at 1st dose, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient had her first dose on 11Mar2021 and was scheduled to return on 01Apr2021. However, she was not able to receive the second dose because she was diagnosed with UTI (urinary tract infection) on an unspecified date in 2021 and was under the medication of antibiotics. The patient also mentioned that on 04Apr2021, she had a surgery on wrist that caused her to delay the second dose again. On 03May2021, the patient reported that it has been six weeks since she had her first Pfizer COVID vaccine, it was on 12Mar2021 (pending clarification). The patient has been unable to get the second shot due to health issues. The patient then asked if she needs to start over with the first shot again or if she can just arrange for the second shot. Outcome of the event was unknown. Information on lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1320259
Sex: F
Age:
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Rec V Date: 05/15/2021
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Symptoms: shingles; This is a spontaneous report from a non-contactable consumer (Pfizer employee). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) at 2nd dose, single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. After the patient got her 2nd Pfizer vaccine for Covid, she got shingles, and she thought they were related. Outcome of the event was unknown. No follow-up attempts are possible, information about batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1320260
Sex: F
Age:
State: PA

Vax Date: 04/15/2021
Onset Date:
Rec V Date: 05/15/2021
Hospital: Y

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Symptoms: tested positive for covid and is in the hospital; tested positive for covid and is in the hospital; This is a spontaneous report received from a contactable consumer (Patient husband) via Medical Information Team. A 61-Year-old female patient received first dose of BNT162B2 (Pfizer- Biontech COVID-19 Vaccine, solution for injection, Lot number: unknown) via an unspecified route of administration on 15Apr2021 (at the age of 61-years-old), as a single dose for Covid-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date, patient tested positive for COVID and was in the hospital. The patient under lab test that included: SARS-CoV-2 test: Positive on an unspecified date. The patient was due for the second dose on 06May2021. The outcome of the events was unknown. Information about batch/lot number has been requested.

Other Meds:

Current Illness:

ID: 1320261
Sex: F
Age:
State:

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Rec V Date: 05/15/2021
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Symptoms: kidney stones; This is a spontaneous report from a contactable consumer. This female consumer (patient) reported that, A female patient of an unspecified age received first dose of bnt162b2 (BNT162B2 solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as 1st dose, single for covid-19 immunisation. The patient medical history and concomitant was not reported. On an unspecified date the patient experienced kidney stones with outcome of unknown. Follow up attempts needed. Further information is expected

Other Meds:

Current Illness:

ID: 1320262
Sex: F
Age:
State: GA

Vax Date: 01/21/2021
Onset Date: 05/03/2021
Rec V Date: 05/15/2021
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Symptoms: COVID-19 confirmed by positive COVID-19 test; COVID-19 confirmed by positive COVID-19 test; This is a spontaneous report from a contactable consumer (patient). A 34-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), 1st dose via an unspecified route of administration, administered in arm left on 21Jan2021 (Batch/Lot Number: EL3302) at the age of 34-year-old as single dose, 2nd dose via an unspecified route of administration, administered in arm left on 10Feb2021 12:00 (Batch/Lot Number: EM9810) at the age of 34-year-old as single dose for COVID-19 immunization. Relevant medical history and relevant past drug history was none. The patient was not pregnant. Concomitant medications included escitalopram oxalate (LEXAPRO); ethinylestradiol, ferrous fumarate, norethisterone acetate (LO LOESTRIN FE); probiotics; paracetamol (TYLENOL). 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. Reported event was tested positive for COVID on 03May2021. Treatment received for the adverse event was medicines and rest. The patient underwent lab tests and procedures which included Lumiradx Sars-Cov-2 AG: positive on 03May2021 (Nasal Swab). The outcome of event was recovering. Follow-up attempts are needed. Further information is expected.

Other Meds: LO LOESTRIN FE; PROBIOTICS; TYLENOL; LEXAPRO

Current Illness:

ID: 1320263
Sex: M
Age:
State: NC

Vax Date: 03/23/2021
Onset Date:
Rec V Date: 05/15/2021
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Symptoms: dvt; diarrhea; okay for him to get the second dose outside of the recommended 3 weeks ( 6 weeks and 2 days ).; This is a spontaneous report from a contactable consumer. This male consumer reported for himself. A 63-years-old male patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 23Mar2021 as 1ST DOSE, SINGLE for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. On unspecified date patient experienced side effects such as diarrhea and DVT on their left leg. As second dose scheduled on 06May2021 wanted to know if it is okay for him to get the second dose outside of the recommended 3 weeks (6 weeks and 2 days). He would like to know if Diarrhea and Blood Clots are side effects of the vaccine as he is currently experiencing these adverse events. The Outcome of the events were unknown. Follow-up (05May2021): This is a Follow-up spontaneous report from a Pfizer-sponsored program. This contactable male consumer reported side effect from the first dose, second dose scheduled on 06May2021. Medical Information: Were any unaddressed medical questions referred or forwarded to Medical Information: Yes: Customer and/or medical inquiry forwarded or referred to MI. Information about lot/ batch number has been requested.

Other Meds:

Current Illness:

ID: 1320264
Sex: F
Age:
State:

Vax Date: 04/10/2021
Onset Date:
Rec V Date: 05/15/2021
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Symptoms: Tendency to glaucoma; She had an episode were her eyes swelled up really bad; Eyes were red and wet; Blurry vision; Eyes were red and wet; This is a spontaneous report from a contactable consumer (patient herself). A 25-year-old female patient received the first dose of the BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot/Batch number: not reported) via an unknown route of administration on 10Apr2021 as SINGLE DOSE for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. In 2021, the patient experienced tendency to glaucoma, she had an episode were her eyes swelled up really bad, eyes were red and wet, blurry vision. The outcome of the events was unknown. It was reported that the patient was supposed to receive the second dose yesterday and she had to reschedule because of events. The patient questioned if there are reports of deaths after getting the vaccine. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1320265
Sex: M
Age:
State: MD

Vax Date: 04/26/2021
Onset Date: 04/27/2021
Rec V Date: 05/15/2021
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Symptoms: my facial paralysis significantly worsened; This is a spontaneous report from a contactable consumer (patient). A 66-year-old male patient received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Right on 26Apr2021 (Lot Number: EW0170) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications included unspecified products within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 and has not been tested for COVID-19 since the vaccination. The patient previously received BNT162B2 lot EW0150 on 05Apr2021 14:00 at left arm for Covid-19 Immunization, 9 days later, on 14Apr2021, woke up with severe facial paralysis and MRI result determined it was Bells Palsy. He received 2nd vaccination on 26Apr2021, the following day on 27Apr2021 his facial paralysis significantly worsened. He cannot close his eye all the way, he cannot keep saliva in his mouth, his speech was impaired, it's difficult to eat and frankly he's mortified to go out in public and terrified that he might have to live this way for a while. The patient received Prednisone as treatment. The event resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The outcome of the event was not resolved.

Other Meds:

Current Illness:

ID: 1320266
Sex: M
Age:
State: PA

Vax Date: 02/14/2021
Onset Date: 03/18/2021
Rec V Date: 05/15/2021
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Symptoms: Acute Deep Vein Thrombosis of the Right Subclavian Vein; Swelling of his right arm; This is a spontaneous report received from a contactable Physician. A 59-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via intramuscular, administered in right arm on 14Feb2021 (Lot Number: el9269) at single dose for COVID-19 immunization in workplace clinic. Medical history included hypertension, hyperlipidemia, lyme, osteoarthritis. There was no known allergies. Concomitant medications included lisinopril; pravastatin; pantoprazole sodium sesquihydrate (PROTONIX). It was unknown if the patient receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took first dose of bnt162b2 via intramuscular, administered in left arm on 24Jan2021 (Lot Number: en5318) at single dose for COVID-19 immunization. The patient evaluated in the emergency room on 18Mar2021 for swelling of his right arm. Patient had a venous doppler right ext, which showed acute deep vein thrombosis of the right subclavian vein. The events result in doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care, and serious for life threatening illness. Treatment for the events included rivaroxaban (XARELTO) and referral to hematologist. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was not resolved.; Sender's Comments: Based on the information currently available, causality between reported events Subclavian vein thrombosis and Peripheral swelling and BNT162B2 vaccine cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Other Meds: LISINOPRIL; PRAVASTATIN; PROTONIX [PANTOPRAZOLE SODIUM SESQUIHYDRATE]

Current Illness:

ID: 1320267
Sex: F
Age:
State:

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Onset Date:
Rec V Date: 05/15/2021
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Symptoms: Hashimoto's Thyroiditis; patchy redness on my cheek; rash; welts; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: Unknown), via an unspecified route of administration on an unspecified date as 1st dose single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date, the patient experienced after the first dose on the 3rd day, she had patchy redness on cheek, then had a rash on her face from earlobe to the other earlobe. It started out as red spots that it's so bad that it welts together. It went down on her neck and she had one spot that stayed on her face and one spot on chest and a rash on face. After the 1st dose, she went to a dermatologist and he put to patient on a topical steroid cream and steroid tablet for 5 days. After she had the 2nd vaccine, she didn't have an outbreak until 2 weeks after because she still had that steroid in her system, she believes. The patient had a sore in mouth after the 2nd outbreak. It was also on lips during 2nd one. The patient stated that her lips were really dry, so it was possibly her body just being run down. About 5-6 days ago, she had a rash, but it has appeared only on my lips. Each time she got this outbreak, she had chills for 4 hours and a low-grade fever. Now it's on her lips and on the outer rim of my lips. She will go to the dermatologist. She also had Hashimoto's Thyroiditis, which reduces her immune system. She has been to urgent care, to HCP, and she stated that it was her 3rd trip to the dermatologist. The outcome of the events was reported as an unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1320268
Sex: F
Age:
State: MI

Vax Date:
Onset Date:
Rec V Date: 05/15/2021
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Symptoms: brain bleeds; headache; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1st dose, single (at the age of 55-year-old) for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient stated that she had brain bleeds on an unspecified date. She had had no headache. The patient stated that she had one (referring to headache) after the vaccine that lasted for three days. She was going to get the second vaccine on 04May2021. The patient did not know if this triggered another bleed. The patient stated that the doctor has not ordered a scan to check if she has had another bleed. The patient did not know if she should get the second dose or not, and wanted to know if it was safe to get the second dose or if it was related to vaccine. The outcome of event headache was recovered, and of the other event was unknown. Information on the lot/ batch number has been requested.

Other Meds:

Current Illness:

ID: 1320269
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 05/15/2021
Hospital: Y

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Symptoms: angioedema, Not just with the pfizer with other things; lupus flare; smelled the metal I taste; This is a spontaneous report from a contactable nurse (reported herself). A 79-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number: unknown, Expiration date: unknown), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. She had unspecified allergies. The patient medical history and concomitant medications were not reported. The patient experienced angioedema not just with the Pfizer with other things, lupus flare and smelled the metal she tastes on an unspecified date. The patient stated that she had angioedema, not just with the Pfizer with other things (Unspecified Medication), that she probably need to hold up and take the injection and she was trying to make sure when she could receive. It was reported that she was just trying to find out if she was qualified to get the injection because she had angioedema. Patient reported that she has a lot of health issues. She has high dose of metal that she smelled (looked at the ingredients: Mercury) and two hospitalizations with severe reactions. The report was not related to the study program. The outcome of the events was unknown. Information about lot/ batch number has been requested. ; Sender's Comments: Based on the limited information currently available the causal association between the reported events angioedema, lupus flare and smelled the metal she tastes and the usage of the vaccine cannot be excluded and meaningfully assessed. The case will be reassessed once the information regarding the date of vaccination and event onset, medical history and concomitant medications are reported. 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: 1320270
Sex: F
Age:
State: TX

Vax Date: 03/04/2021
Onset Date: 03/01/2021
Rec V Date: 05/15/2021
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Symptoms: Patient reported clot developed in calf 1 week following first dose; Confusion; This is a spontaneous report from a contactable consumer (reporting for herself). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 04Mar2021 (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for COVID-19 immunization; and sarilumab (KEVZARA), via an unspecified route of administration from 05Mar2021 (Batch/Lot number was not reported) at an unknown dose and frequency for an unspecified indication. The patient medical history was not reported. Concomitant medication included enoxaparin sodium (LOVENOX [ENOXAPARIN SODIUM]) taken for an unspecified indication, start and stop date were not reported. In Mar2021, the patient reported that clot developed in calf 1 week following first dose of Pfizer covid-19 vaccine. Also, with a lot of confusion. She stated that she was driving and got lost in her 1 stoplight/1-mile small town. The outcome of the events was unknown. The action taken in response to the event for sarilumab was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds: LOVENOX [ENOXAPARIN SODIUM]

Current Illness:

ID: 1320271
Sex: U
Age:
State: NJ

Vax Date:
Onset Date:
Rec V Date: 05/15/2021
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Symptoms: got COVID after the 1st shot; got COVID after the 1st shot; This is a spontaneous report from a contactable consumer. This consumer reported similar events for three patients. This is the first of three reports. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number was not reported), via an unspecified route of administration on an unspecified date as 1st dose, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, it was reported that the patient got COVID after the 1st shot. The patient underwent lab tests and procedures which included COVID-19 test: positive on an unspecified date. The outcome of the events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : PFIZER INC-2021503620 same reporter/vaccine, similar events, different patient; PFIZER INC-2021503619 same reporter/vaccine, similar events, different patient

Other Meds:

Current Illness:

ID: 1320273
Sex: U
Age:
State: NJ

Vax Date:
Onset Date:
Rec V Date: 05/15/2021
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Symptoms: got COVID after the 1st shot; got COVID after the 1st shot; This is a spontaneous report from a contactable consumer. This consumer reported similar events for three patients. This is the third of three reports. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number was not reported), via an unspecified route of administration on an unspecified date as 1st dose, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, it was reported that the patient got COVID after the 1st shot. The patient underwent lab tests and procedures which included COVID-19 test: positive on an unspecified date. The outcome of the event was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : PFIZER INC-2021503608 same reporter/vaccine, similar events, different patient.; PFIZER INC-2021503619 same reporter/vaccine, similar events, different patient.

Other Meds:

Current Illness:

ID: 1320274
Sex: F
Age:
State: FL

Vax Date: 04/29/2021
Onset Date: 04/30/2021
Rec V Date: 05/15/2021
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Symptoms: Unable to fully extent her arm past the 90? angle/her arm is very stiff, she can rotate it, but can't extend it; This is a spontaneous report received from a contactable consumer (Patient, reported for herself). A 19-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot number and expiration date was unknown), dose 2 via an unspecified route of administration, in arm left on 29Apr2021 15:00 (at the age of 19-year-old) as single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient stated she just knows her family has a history of high blood pressure, but she is in perfect health. The patient previously received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot number and expiration date was unknown), via an unspecified route of administration, in arm left on an unspecified date 09:00 (at the age of 19-year-old) as single for COVID-19 immunization. The patient did not get any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not report any side effects prior vaccination. The patient did not administer additional vaccines on same date of vaccination. The patient experienced unable to fully extent her arm past the 90 degree angle/her arm is very stiff, she can rotate it, but she cannot extend it on 30Apr2021. The patient caller reported being unable to fully extent her arm past the 90 degree angle after getting the second dose of the Pfizer-BIONTECH COVID-19 vaccine. She explained the affected arm is where she received the vaccine. She asked if her symptom was reported as a side effects from the vaccine, and how to treat it. Patient stated that she visited an emergency room on Saturday and they gave her FLEXERIL, a muscle relaxant, and it has not really done much. Caller stated FLEXERIL is 5 mg twice a day by mouth. Patient stated she took FLEXERIL and she is been taking Aleve too but it is the Aleve for back and muscle, she thought it is 50mg or something around that. Seriousness of the event was reported as serious, medically significant. The outcome of event was not recovered. Information on lot/ batch number has been requested.

Other Meds:

Current Illness:

ID: 1320276
Sex: M
Age:
State: NC

Vax Date: 05/01/2021
Onset Date: 05/02/2021
Rec V Date: 05/15/2021
Hospital: Y

Vax Type:
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Symptoms: flu-like symptoms; oxygen saturation is low; having difficulty breathing; experiencing a rapid heart rate/ had tachycardia, fast heart beat; being tested for Covid 19; complaining of feeling unwell since receiving the first dose of the Pfizer Covid vaccine; his nose was very stuffy; needed to blow his nose like 100 times; This is a spontaneous report from a contactable consumer (patient's daughter). A 72-years-old male patient (reporter's father) received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date was not reported), via an unspecified route of administration, administered in arm on 01May2021 (at the age of 72-years-old) as a single dose for covid-19 immunization. Medical history included hypertension, tachycardia. The patient's concomitant medications were not reported. On 02May2021, the patient was complaining of feeling unwell since receiving the first dose of the Covid vaccine. Caller states father has been having flu-like symptoms. His oxygen saturation was low and he was having difficulty breathing. He was experiencing a rapid heart rate and currently was being tested for Covid 19, he was having chest ray done, and blood work. his heart rate was like 140 and then his oxygen would go down to 80. Caller states she didn't know if Pfizer has ever heard of symptoms like that. Caller states she just wanted to know what was going on, he's in the hospital now. The patient had tachycardia, fast heart beat. Caller states he is 72 years old, he was just laying down and felt his heart really bad, they used a monitor and his heart rate was 140, it was super elevated. Caller states they used the oxygen thing that they put on his finger and the oxygen levels were 80 so it was really low. Caller states he was completely fine, he never went out of the house, he was completely fine, normal. Caller states he does have hypertension though and he drinks medicine for that but she doesn't know which medicine it is. Caller states the first day they applied the vaccine, he felt good. Caller states the second day, he didn't feel good, had flu-like symptoms, his nose was very stuffy, he needed to blow his nose almost 100 times, he was not feeling well at all. Caller states her mom had to take him to the hospital. Reporter enquired if my father could take the second dose since he had this reaction and got answer that should not get COVID-19 Vaccine if you had a severe allergic reaction after a previous dose of this vaccine and had a severe allergic reaction to any ingredient of this vaccine. The patient was taking Pfizer Covid vaccine because he wants to be protected. Caller verifies the patient is continuing to have all symptoms reported still. Caller states he was super healthy and he just went there and took the vaccine and he never goes out, so she doesn't know. Caller reports all of patient's symptoms reported have worsened. Caller verifies it was an injection in his arm, but doesn't know which arm. Caller also unsure of dosage given. Caller states they were like no only Pfizer, so he waited so long for Pfizer and finally when he applied to Pfizer and got it, he was so happy and so now he's so sad because he feels bad. Caller requesting to be transferred to the medical staff at this time. Caller states she doesn't have time to finish the report for her father or herself because her lunch break is almost over. The patient underwent lab tests and procedures on 02May2021 which included heart rate: 140- super elevated , oxygen saturation: 80 -really low , covid-19 positive: positive .The seriousness of the event was considered as serious hospitalisation by reporter. Outcome of the events was not recovered. Follow up attempts are needed. information about lot/batch number cannot be obtained.

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Current Illness:

ID: 1320277
Sex: F
Age:
State: MA

Vax Date: 02/17/2021
Onset Date: 05/01/2021
Rec V Date: 05/15/2021
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Symptoms: COVID-19 confirmed by positive COVID-19 test; COVID-19 confirmed by positive COVID-19 test; This is a spontaneous report from a contactable consumer (patient). A 23-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided), 1st dose via an unspecified route of administration, administered in arm left on 28Jan2021 as a single dose, 2nd dose via an unspecified route of administration, administered in arm left on 17Feb2021 as a single dose; both at age of 23 years old for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient contracted COVID-19 after being fully vaccinated on 01May2021. No treatment was received for the events. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. And the patient had no COVID-19 prior vaccination. The report was reported as non-serious. The patient underwent lab tests and procedures which included PCR test: positive (nasal swab) on 04May2021. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

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Current Illness:

ID: 1320278
Sex: F
Age:
State: MS

Vax Date: 04/15/2021
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Rec V Date: 05/15/2021
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Symptoms: Patient is feeling weak; All she wants to do is to sleep; This is a spontaneous report from a contactable consumer reported a female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), dose 1 via an unspecified route of administration on 15Apr2021 as 1ST DOSE SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. Patient was feeling weak and all she wanted to do was to sleep and she did not know when she going out of the hospital. Patient was scheduled for the 2nd dose on 06May2021. The outcome of the events was unknown. Information on the lot/batch number has been requested.

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Current Illness:

ID: 1320279
Sex: F
Age:
State: CO

Vax Date: 04/12/2021
Onset Date: 04/22/2021
Rec V Date: 05/15/2021
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Symptoms: chest pain; pulse started racing; dizzy and light headed; significant allergic reaction to the vaccine/Respiratory tract oedema /Flushing/urticaria/swollen tongue/Pharyngeal swelling/Dizziness; mental fog; This is a spontaneous report from a contactable consumer (patient). A 34-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm right on 12Apr2021 14:45 (Batch/Lot Number: Er8737) as 2nd dose, single for covid-19 immunisation. The first dose was received on 22Mar2021 14:45 (lot number: En6208) on the left arm. Medical history included polycystic ovaries, thyroid and serious food allergies. Concomitant medications included levothyroxine sodium (TIROSINT) taken for an unspecified indication, start and stop date were not reported. Approximately 10 minutes after shot on 22Apr2021 15:00 (2nd dose only) patient was flushed, pulse started racing, and hives appeared all over her chest. Over the next hour hives worsened, heart rate stayed fast, had swelling in tongue and throat, and became dizzy and light headed. Patient's husband wanted to take her to ER, but patient was stupidly resistant. She took a large dose of Benadryl. As the swelling in her airway lessened and the mental fog passed it became more obvious that patient had been having a significant allergic reaction to the vaccine. She was instructed to wait at the pharmacy she received the shot at for only 5 minutes because she had not had an adverse reaction to the 1st dose. She was alone when the reaction began. Patient took a 2nd dose of Benedryl before bed. The next day on 23Apr2021, chest pain began again and patient did go to the ER. The doctor believed symptoms on day 1 were an allergic reaction to vaccine and on day 2 were a strong immune response to the vaccine. They did an EKG and monitored the patient. She reported she was okay at the time of report. Patient received treatment for the events. Outcome was recovered. Patient was not diagnosed with COVID prior to vaccination and had not been tested post-vaccination Information on the lot/batch number has been requested.

Other Meds: TIROSINT

Current Illness:

Total 2021 VAERS Injuries: 559,999

Page last modified: 03 October 2021 5:28pm