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
86,983
AK1,797
AL6,084
AR3,947
AS45
AZ14,444
CA64,247
CO12,095
CT8,676
DC1,739
DE1,854
FL41,197
FM3
GA15,750
GU92
HI2,442
IA4,718
ID2,737
IL21,330
IN23,567
KS4,796
KY8,305
LA5,287
MA15,198
MD13,033
ME3,262
MH8
MI20,025
MN12,747
MO10,141
MP30
MS3,054
MT2,378
NC17,317
ND1,432
NE3,005
NH3,110
NJ19,339
NM4,071
NV4,562
NY36,265
OH19,983
OK6,487
OR8,860
PA24,780
PR2,472
QM2
RI2,083
SC6,906
SD1,236
TN9,935
TX38,463
UT4,458
VA15,392
VI62
VT1,772
WA15,366
WI11,500
WV2,436
WY884
XB5
XL1
XV2

ID: 1316115
Sex: F
Age:
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Onset Date: 04/01/2021
Rec V Date: 05/14/2021
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Symptoms: She has had pain in that arm; It feels like something is crawling down her arm to her fingers that are numb and tingling; It feels like something is crawling down her arm to her fingers that are numb and tingling; This is a spontaneous report from a contactable consumer (reported on herself). A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot Number and Expiration Date was not reported), via an unspecified route of administration in Arm Left on an unspecified date as 2nd dose, dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine includes BNT162B2 1st dose, single for COVID-19 immunization. Patient was a teacher, female and would like to know if numbness and tingling sensation are reported side effects of getting the BNT162B2. She experienced these side effects after getting the second dose of the vaccine. Patient states that she was calling to find out if something was a side effect of the COVID-19 Pfizer Shot. States that she had both doses of the shot in her left arm. For the past 2 and a half weeks she has had pain in that arm and it feels like something is crawling down her arm to her fingers that are numb and tingling. States she has discussed this with others who had the vaccine at the same time as her and a couple of them said they had it too. No further information or identifiers provided by patient. States she was about to go to the Emergency Room about this symptom. The outcome of the events was un-known. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1316116
Sex: F
Age:
State:

Vax Date: 04/21/2021
Onset Date: 04/22/2021
Rec V Date: 05/14/2021
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Symptoms: I felt like an electric shock in my body; something crawling inside her throat; Dizziness and lightheaded ness; Heart rate was up; I could not breathe properly; felt a sensation in her throat/t was like something was stuck in the upper part of her chest and throat; Panic attack; felt a sensation in her throat/t was like something was stuck in the upper part of her chest and throat; This is a spontaneous report received from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (Pfizer-BioNTech COVID-19 vaccine), dose 1 via an unspecified route of administration on 21Apr2021 (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient reported that the day she got the vaccine she was ok but the next day around 10 am (22Apr2021) she had sudden dizziness and lightheadedness, her heart rate was up and felt she could not breathe properly. The patient opened the door to get oxygen, drank some water and ate, it took 1 hour and she felt better. That same night she felt a sensation in her throat, she was able to breathe when she took deep breaths but it was like something was stuck in the upper part of her chest and throat, It lasted a few minutes. On Friday (23Apr2021) in the night she felt again something weird like something crawling inside her throat, she felt like an electric shock in her body and heart rate went up. She went out to take fresh air and felt better. The patient did go to the hospital on Friday night, they checked her oxygen and lungs it was ok, it was normal. The patient was told at the hospital that she could take the 2nd dose, was told it could be a panic attack, not likely an allergic reaction. 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: 1316117
Sex: F
Age:
State: CO

Vax Date: 03/18/2021
Onset Date:
Rec V Date: 05/14/2021
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Symptoms: Elevated (doubled) bilirubin; This is a spontaneous report received from a contactable pharmacist. A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) dose 1 via an unspecified route of administration, on 18Mar2021 and dose 2 on 08Apr2021 as a single dose, for covid-19 immunisation. Medical history of the patient included metastatic breast cancer and Gilbert disease. Concomitant medications were not reported. On an unspecified date in 2021, the patient experienced elevated (doubled) bilirubin after her vaccine series. Outcome of event was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021473014 same reporter/drug/AE, different patients(2nd of 3 patients);US-PFIZER INC-2021473015 same reporter/drug/AE, different patients (3rd of 3 patients);US-PFIZER INC-2021473013 same reporter/drug/AE, different patients (1st of 3 patients)

Other Meds:

Current Illness:

ID: 1316118
Sex: M
Age:
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Rec V Date: 05/14/2021
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Symptoms: swelling upon administration; This is a spontaneous report from a contactable consumer (patient). A 63-year-old adult male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration at the "top of the arm" on unknown date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and the patient's concomitant medications were not reported. The patient experienced minimal to no pain (only some swelling upon administration) on an unspecified date with outcome of unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1316119
Sex: F
Age:
State: IL

Vax Date: 03/19/2021
Onset Date:
Rec V Date: 05/14/2021
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Symptoms: partial hearing loss, 20%; tinnitus; This is a spontaenous report from a contactable consumer. A 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 19Mar2021 (Lot Number: ER2613) as 1ST DOSE, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced partial hearing loss, 20% and tinnitus on an unspecified date. The patient underwent lab tests and procedures which included Sars-Cov-2 antibody test: negative on 26Apr2021. Outcome of the events was unknown. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1316120
Sex: F
Age:
State: TX

Vax Date: 01/07/2021
Onset Date: 01/01/2021
Rec V Date: 05/14/2021
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Symptoms: rash in face and back; This is a spontaneous report from a contactable consumer (patient herself). A 32-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 07Jan2021 14:30 (Batch/Lot Number: Ej1686) as 1st dose, single for COVID-19 immunisation. Medical history included immunoglobulin g4 related disease (IGG4-RD) and rheumatoid arthritis. The patient was not diagnosed with COVID-19 prior to vaccination. The patient's concomitant medications were not reported. The patient previously took rituxan and experienced allergies. The patient experienced rash in face and back on an unspecified date in Jan2021. The outcome of event was recovering. Information about bat/lot number has been obtained.

Other Meds:

Current Illness:

ID: 1316121
Sex: M
Age:
State:

Vax Date: 04/01/2021
Onset Date: 04/01/2021
Rec V Date: 05/14/2021
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Symptoms: head aches; double vision; This is a spontaneous report from a non-contactable consumer (patient). A 55-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: unknown), via an unspecified route on 01Apr2021 as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced head aches on 01Apr2021 and double vision on unspecified date in Apr2021. Patient stated that since he had the second shot Pfizer 01Apr2021, that same day he started having head aches and hasn't stopped since, last week Wednesday, he started having double vision that still exists, went to the eye doctor, bought new glasses. They want him to see a specialist next. Since he had the second shot this has been going on with him that is why he thought it was related to the vaccine. He asked is there anything else he should be doing. Response was a review of the prescribing information for Pfizer BIONTECH COVID 19 VACCINE did not find information regarding double vision. Pfizer cannot assess causality (i.e., cannot assess if what you described/are experiencing is associated with the Pfizer BIONTECH COVID 19 VACCINE). Beyond what is described in the

Other Meds:

Current Illness:

ID: 1316122
Sex: F
Age:
State: IA

Vax Date: 04/07/2021
Onset Date: 04/17/2021
Rec V Date: 05/14/2021
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Symptoms: had episode of SVT and sinus tachycardia/ heart has been unstable; had episode of SVT and sinus tachycardia/ heart has been unstable; This is a spontaneous report from a contactable consumer (patient). A 35-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EW0153) via an unspecified route of administration, administered on the left arm on 07Apr2021 04:30 1st dose, single for COVID-19 immunization. The patient had no medical history. The patient's concomitant medications were not reported. On 17Apr2021, she had episode of SVT and sinus tachycardia. Then again on 23Apr2021. Her heart has been unstable since. The events resulted in Emergency room/department or urgent care visit and Doctor or other healthcare professional office/clinic visit. Treatment received: patient is now on meds to regulate her heart and blood tests (15Apr2021: negative). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were no other medications the patient received within 2 weeks of vaccination. Patient was not pregnant. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, has the patient been tested for COVID-19: Nasal Swab negative on 15Apr2021. The facility where the vaccine was administered was in a doctor's office/urgent care. Event was reported as non-serious: did not result in death, was not life-threatening, did not cause/prolonged hospitalization, was not disabling/incapacitating and did not cause congenital anomaly/birth defect. Outcome of the events was not recovered.

Other Meds:

Current Illness:

ID: 1316123
Sex: F
Age:
State: MD

Vax Date: 03/12/2021
Onset Date: 03/19/2021
Rec V Date: 05/14/2021
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Symptoms: Vesicular rash; Shingles outbreak; This is a spontaneous report from a contactable other healthcare professional (patient's daughter). A 74-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6208), via an unspecified route of administration, administered in the right arm, on 12Mar2021, as 1st dose, single, for COVID-19 immunisation; and the second dose of hepatitis B vaccine (trade name unspecified, lot number not reported), via an unspecified route of administration, on 15Mar2021, at an unspecified dose, for immunization. The patient's medical history included hemodialysis from 2016 and ongoing (has been on hemodialysis for maybe 5 years), possible shingles and chickenpox when she was a kid. Concomitant medications were unspecified, there is quite an extensive list of medications (unspecified) the patient is on. It was reported that the patient had the hepatitis B shot too close to the COVID-19 vaccine. On 12Mar2021, the patient received the COVID-19 vaccine. On 15Mar2021, at her dialysis treatment, the patient received the second shot of the hepatitis B vaccine. It was reported as an error as it was administered too close to the Pfizer COVID-19 vaccine. By that Friday, 19Mar2021, the patient had a vesicular rash that the reporter would guess was a shingles outbreak. The patient was taken to her primary doctor for the events. The reporter thought this was related to the patient's immune system dealing with 2 vaccines and the virus had the opportunity. Treatment for the events included a whole course of antiviral (unspecified) which started on 19Mar2021. The patient then received her second dose of COVID-19 vaccine on 03Apr2021 (lot number: ER8732) in her right arm. The dialysis clinic said they would continue to give the next hepatitis B shot and the reporter asked them to hold on while she gets more information. The reporter asked about the implications of receiving the hepatitis B vaccine too close to the first dose of COVID-19 vaccine and asked when they should resume the hepatitis B shots. The patient recovered from the events on an unspecified date (reported as "went away at the end of the 10-day course of the antiviral"). No follow up attempts are needed. No further information expected.

Other Meds:

Current Illness: Hemodialysis (She has been on hemodialysis for maybe 5 years.)

ID: 1316124
Sex: F
Age:
State:

Vax Date: 03/31/2021
Onset Date: 04/03/2021
Rec V Date: 05/14/2021
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Symptoms: Herpes Zoster aka Shingles; This is a spontaneous report from a contactable consumer (patient). A 35-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCIN), via an unspecified route of administration, administered on the left arm on 31Mar2021 08:30 (Batch/Lot Number: ER8734) as unknown, single for covid-19 immunisation. Medical history included chronic migraine, wheat allergy and covid-19 prior to vaccination. No other vaccines were received in 4 weeks. Patient was not pregnant. The patient's concomitant medications were not reported. The patient experienced herpes zoster aka shingles on 03Apr2021 08:00. Event resulted in healthcare professional office/ clinic visit. Unspecified antiviral was given as treatment. Outcome of the event was recovering. The event was considered non-serious by the reporter. Patient had not been tested post-vaccination. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1316125
Sex: M
Age:
State: MI

Vax Date: 04/08/2021
Onset Date: 04/22/2021
Rec V Date: 05/14/2021
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Symptoms: had a virus; This is a spontaneous report from a contactable consumer (patient). A 63 years old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 08Apr2021 (Batch/Lot Number: EW0150) as single dose at right arm for covid-19 immunisation. Medical history was none. Concomitant medication(s) included amlodipine besilate for blood pressure abnormal. The patient reported that on 22Apr2021, he went to the emergency and they said he had a virus and he had appointment made there, so he want to know did he went there to take his second shot or what did he do next. Consumer stated that No Treatment receive, he was hydrated and they gave him through the bottles in the hospital and send him home the same day. The outcome of the event was unknown.

Other Meds: AMLODIPINE BESYLATE

Current Illness:

ID: 1316126
Sex: F
Age:
State:

Vax Date: 04/19/2021
Onset Date: 04/24/2021
Rec V Date: 05/14/2021
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Symptoms: labored breathing; heart rate elevated; This is a spontaneous report from a contactable consumer (patient). A female patient of unknown age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 19Apr2021 at single dose for COVID-19 immunisation. Medical history included dyslexia. Concomitant medication was not reported. The patient received her first dose of Pfizer vaccine last Monday (19Apr2021). She went to the ER Saturday (24Apr2021) experiencing symptoms when she got home and last week. Is for the Covid 19 vaccine. She had dyslexia which was before vaccine. She had labored breathing after the vaccine and her heart rate was elevated. She was unable to bring her heart rate down. It was difficult to walk upstairs and read warm ups for her senior citizens. The outcome of the events was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1316127
Sex: M
Age:
State: PA

Vax Date: 04/20/2021
Onset Date: 04/24/2021
Rec V Date: 05/14/2021
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Symptoms: he lifted a heavy object and tore the bicep distal tendon in that same (left) arm; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 20Apr2021 13:30 (Batch/Lot Number: EW0162) (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history included cholesterol and spinal disc surgical repair in 2005. Concomitant medications included atorvastatin; cetirizine; aspirin [acetylsalicylic acid] (ASPIRIN), all were taken for an unspecified indication, start and stop date were not reported. The patient previously took codeine and experienced rash and wool-lanolin and experienced itch. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient had not received other vaccine in four weeks. On 24Apr2021 18:00, four days after injection into his left arm, he lifted a heavy object and tore the bicep distal tendon in that same (left) arm which resulted in doctor or other healthcare professional office/clinic visit. The patient received treatment for the event and surgical repair to be scheduled as soon as possible (ASAP). The outcome of event, he lifted a heavy object and tore the bicep distal tendon in that same (left) arm, was not recovered. No follow-up attempts are needed. No further information is expected.

Other Meds: ATORVASTATIN; CETIRIZINE; ASPIRIN

Current Illness:

ID: 1316128
Sex: M
Age:
State: CT

Vax Date: 04/23/2021
Onset Date: 04/27/2021
Rec V Date: 05/14/2021
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Symptoms: feel unwell; developed shingles; This is a spontaneous report from a contactable consumer (patient's wife). A 38-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered on left arm on 23Apr2021 (Batch/Lot Number: ER8735) as 2nd dose, single (at the age of 38 years old) for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1, at the age of 38 years old for COVID-19 immunisation. The patient experienced Pfizer covid 19 vaccine on 23Apr2021. he started to feel unwell Sunday into Monday and was formally diagnosed with shingles yesterday (27Apr2021). Treatment for adverse event: Reporter stated, "They just provide valacyclovir, that's the antiviral an the other one is, shingles can cause like nerve pain, Gabapentin. It's 1gram tablet and the tablet has to be taken by mouth three times a day for week. It's 100mg one capsule by mouth 3 times daily for the 30 dosages". The outcome of shingles was not recovered and other event was unknown. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1316129
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 05/14/2021
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Symptoms: the rash across the midline (Across my face up to my left eye, neck, left and right arms, stomach, right leg); shingles; This is a spontaneous report from a non-contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced the rash across the midline (Across my face up to my left eye, neck, left and right arms, stomach, right leg) but that's how the patient's family apparently gets shingles on an unspecified date. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1316130
Sex: F
Age:
State: GA

Vax Date: 03/24/2021
Onset Date: 03/24/2021
Rec V Date: 05/14/2021
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Symptoms: She did not sleep well due to the discomfort; sore arm; Swollen lymph nodes; Discomfort in neck, shoulder, and elbow on right side; Discomfort in neck, shoulder, and elbow on right side; Discomfort in neck, shoulder, and elbow on right side; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received the 2nd dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration in arm right, on 24Mar2021 morning (Lot Number: ER8730), as single dose, for COVID-19 immunisation. Medical history included hypertension. Concomitant medication included hydrochlorothiazide, valsartan (VALSARTAN HYDROCHLOROTHIAZIDE KRKA) taken for hypertension from around 2 years before. The patient previously took influenza vaccine for immunisation in Oct2020, valsartan for hypertension (discontinued), the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech) for COVID-19 immunisation and experienced chest discomfort, neck discomfort and lymphadenopathy. The patient experienced discomfort in neck, shoulder, and elbow on right side (non-serious) in 2021 with outcome of not recovered, sore arm (non-serious) on 24Mar2021 with outcome of not recovered, swollen lymph nodes (non-serious) in 2021 with outcome of not recovered, she did not sleep well due to the discomfort (non-serious) in Apr2021 with outcome of unknown. Therapeutic measures were taken as a result of discomfort in neck, shoulder, and elbow on right side and sore arm and included treatment with ibuprofen about every 3 days for the last week and a half. The patient reported that at first it was just in her arm which was a little bit sore and then it went down to her elbow and has never gone away. Discomfort was actually under her shoulder blade. She clarifies it did not stop at the top of her shoulder, it was also under her shoulder blade. No follow-up attempts are needed. No further information is expected.

Other Meds: VALSARTAN HYDROCHLOROTHIAZIDE KRKA

Current Illness:

ID: 1316131
Sex: M
Age:
State: FL

Vax Date: 04/05/2021
Onset Date:
Rec V Date: 05/14/2021
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Symptoms: the pain was shooting down to his heart; severe pain in his left shoulder after that second dose; injection site pain; pain is around his arms/going on the top of his legs; back and wraps down to the heart; major pain up around his shoulders and around the back of neck; I have stomach problems, I am collapsed stomach; This is a spontaneous report from a contactable consumer (patient). This 55-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) in his left arm on 05Apr2021 at single dose for COVID-19 immunisation. Medical history included Arthritis, Sinus problem, Asthma, Bipolar disorder. Concomitant medications were not reported. The patient previously received first dose of BNT162B2 on unspecified date at age of 55 years old for COVID-19 immunisation. The patient experienced injection site pain, severe pain in his left shoulder after that second dose. Some major pain up around his shoulders and around the back of neck, his left side was worst. He said that the pain was shooting down to his heart. So he went to the hospital because he thought it was something to the heart. They tested him, they evaluated him but they ruled out anything that has to do with the heart. They checked his heart, he had a cardiac catheterization, and was ruled out, everything came out negative. So, he just got out of hospital and was still developing the pain and it's on his left side, it's on his right side (as reported). He called all his doctors, they had no answers for him, now he was still in a lot of pain in both of shoulders like he was saying his left side was still the worst, and it has not gone away and the pain is still shooting down around his heart and shooting down around the back of neck and now it's going on the top of his legs. He went to the bone doctor and he was getting an MRI done, because the doctors said nothing was torn in his arms or tissues. He stated the pain was around his arms, back and wraps down to the heart. He was in dire pain, 8.5/10 and had a feeling of it was related to the vaccine. He clarified the pain was in both shoulders and the left side was worse and that was the side he had his shot on. Patient stated he had stomach problems, he was collapsed stomach. The outcome of events was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1316132
Sex: F
Age:
State:

Vax Date: 04/01/2021
Onset Date: 04/01/2021
Rec V Date: 05/14/2021
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Symptoms: positive COVID-19 test; positive COVID-19 test; This is a spontaneous report from a contactable pharmacist received via the medical information team. A female patient of unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 01Apr2021 as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date in Apr2021, the patient tested positive for COVID-19. The reporter questioned if there was a specific amount of time the patient had to wait before getting the second dose. The clinical outcome of positive COVID-19 test was unknown. Information on batch number has been requested; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of COVID-19 and suspected LOE. There is limited information provided in this report. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to agency, as appropriate.

Other Meds:

Current Illness:

ID: 1316133
Sex: F
Age:
State: NC

Vax Date: 04/06/2021
Onset Date: 04/01/2021
Rec V Date: 05/14/2021
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Symptoms: Sometimes similar to the feeling she had when she had shingles in the past; She says it feels like period symptoms; This is a spontaneous report received from a contactable consumer (patient's husband). A 59-year-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration on 06Apr2021 (Batch/Lot number was not reported) as 1st dose, single for COVID-19 immunization. Medical history included shingles. The patient's concomitant medications were not reported. The patient has developed issues on Apr2021, she says it feels like period symptoms and sometimes similar to the feeling she had when she had shingles in the past. They recently read of possible side effects that include the vaccine possibly stimulating previous auto immune issues. Should she get the 2nd shot or visit with physician before receiving? The outcome of the events was unknown. Information on the lot/batch number has been requested.

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Current Illness:

ID: 1316134
Sex: M
Age:
State: NJ

Vax Date: 04/10/2021
Onset Date: 04/11/2021
Rec V Date: 05/14/2021
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Symptoms: body aches; chest pain; pressure on chest; low fever; cold; tested positive for covid 19; This is a spontaneous report from a contactable consumer report for self from a Pfizer sponsored program Covax US Support. A 62-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 10Apr2021 16:30 (Batch/Lot Number: EW0158) as single dose for covid-19 immunisation. No additional vaccines administered on same date of the Pfizer suspect. No prior Vaccinations within 4 weeks. Medical history included ongoing high blood pressure started 8-9 years ago. Concomitant medications included lisinopril (LISINOPRIL) taken for high blood pressure about few years; acetylsalicylic acid (BAYER ASPIRIN) taken to keep the blood thin and blood pressure; Carvedilol taken for heart valve, something to do with his heart since couple years ago. Patient received his first vaccine dose on 10Apr2021 and on 11Apr2021 tested positive for covid 19. He was at Emergency Department on an unspecified date. He went because he had body aches, chest pain, pressure on chest, once in a while had low fever, cold, and achy body. He was given a treatment, but doesn't know the name of what was given. It was through the Intravenous site. Patient no longer has symptoms and has completed his required isolation. He is due to get his second vaccine dose on 01May and asked do he get second dose or should wait. The outcome of events was unknown.

Other Meds: LISINOPRIL; BAYER ASPIRIN; CARVEDILOL

Current Illness: Blood pressure high (started 8-9 years ago)

ID: 1316135
Sex: M
Age:
State: MS

Vax Date: 03/22/2021
Onset Date: 03/22/2021
Rec V Date: 05/14/2021
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Symptoms: caller is disabled and has a bad back and stuff; have tons of ills because of the shot; felt soreness in the arm; Sleepiness; caller was tired; The initial safety information received was reporting only non-serious adverse drug reactions, upon receipt of follow-up information on 28Apr2021, this case now contains serious adverse reactions. Information processed together. This is a spontaneous report from a contactable consumer (patient). A 65-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 22Mar2021 between 09:00-10:00 (Lot Number: EP6955) as 1st dose, single for COVID-19 immunisation. There was no medical history, no family medical history relevant to adverse events. The patient's concomitant medications were not reported. There were no prior vaccinations within 4 weeks. The patient felt soreness in the arm and it made him sleepy after the first dose of the Pfizer COVID-19 vaccine in the evening of 22Mar2021. When he got back home the same day 22Mar2021 sleepiness began. The patient stated this was probably going to happen anyway, he was disabled and had a bad back and stuff on an unspecified date. The patient had to drive 30 some miles, 31 miles to be exact to see the doctor to receive the Pfizer Covid Vaccination. When he returned from the trip he was tired and would go to sleep anyway on 22Mar2021. The patient stated soreness in the arm had been gone for maybe 3 or 4 days, he was good, no problem with arm, and sleepiness went away. The patient mentioned that he had tons of ills on unspecified date because of the shot. The patient was not experiencing any of this before having the Pfizer Covid Vaccine. The events did not require a visit to Emergency room or Physician office. There were no relevant tests. The outcome of events felt soreness in the arm and Sleepiness was recovered, and of the other events was unknown.

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Current Illness:

ID: 1316136
Sex: M
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Symptoms: This is a spontaneous report from a contactable pharmacist received via Medical Information Team. A 71-year-old male 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 and concomitant medications were not reported. The patient experienced worsening control of blood glucose since receiving vaccine on an unspecified date. The patient outcome of the event was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.; Sender's Comments: Based on the information provided by the reporter, it appears unlikely that subject vaccine contributed to the event of worsening control of blood glucose. The reported event likely represent intercurrent medical condition. There is 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:

Current Illness:

ID: 1316137
Sex: F
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Rec V Date: 05/14/2021
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Symptoms: woke up my eye burned like somebody touch me, was color blue like someone hit me. only right side; woke up my eye burned like somebody touch me, was color blue like someone hit me. only right side; This is a spontaneous report from a non-contactable consumer (patient). A 59-years-old female patient received the first dose bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on an unspecified date (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date the caller reported I woke up and my eye burned like somebody touch me, was color blue like someone hit me. Only right side. I got my injection in the left arm. Consumer inquired What happens in the second vaccine? Can it be worse after the second? Is there any record of this happening on the inside. (bruising, blood clotting) ? The clinical outcome of the events was unknown. No follow-up attempts are possible. No further information expected.

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Current Illness:

ID: 1316138
Sex: F
Age:
State:

Vax Date: 04/26/2021
Onset Date: 04/28/2021
Rec V Date: 05/14/2021
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Symptoms: Heart rate is also down from 60 to 49; Her usual blood pressure is 102/60, however it is at 134/64 right now; She has light-headedness/dizziness; This is a spontaneous report received a contactable pharmacist. A female of unspecified age received a dose (unspecified dose number) of BNT162b2 (solution for injection; batch/lot and expiry information not provided) as a single dose via unspecified route on 26Apr2021 (reported as forty-eight hours ago) for COVID-19 immunisation. There was no medical history, concomitant medications or past drug history reported. The pharmacist reported that her cousin received the Pfizer COVID vaccine forty-eight hours ago. The pharmacist reported that her cousin's blood pressure is usually 102/60, however it is at 134/64 on 28Apr2021 (reported as right now). The pharmacist also mentioned that her heart rate is also down from 60 to 49 and she has light-headedness and dizziness on 28Apr2021 (reported as right now). The outcome of the events blood pressure 134/64 right now, heart rate is also down from 60 to 49, and light-headedness and dizziness, was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of HR decreased, BP increased and dizziness. There is limited information provided in this report. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to agency, as appropriate.

Other Meds:

Current Illness:

ID: 1316139
Sex: F
Age:
State: TN

Vax Date: 03/29/2021
Onset Date: 04/01/2021
Rec V Date: 05/14/2021
Hospital: Y

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Symptoms: appendix ruptured/aapendicitis; mild flu symptoms; energy level was low; stool is soft; bowel movements are not consistent; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, Lot Number: ER8737), via an unspecified route of administration, administered in the right arm on 29Mar2021 as a single dose for COVID-19 immunization. Medical history included allergy to penicillin from an unknown date and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included lisdexamfetamine mesilate (VYVANSE, reported as 'VYVANSE Xr'); duloxetine (manufacturer unknown) and lamotrigine (manufacturer unknown) all taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 05Apr2021, the patient had stomach ache and pains. On 06Apr2021, the stomach pains were constant and sometimes sharp and there were mild flu symptoms. On 07Apr2021, the patient had severe stomach pain and flu symptoms. The patient took a nasal swab rapid COVID test also which came back negative. In the afternoon of 07Apr2021, the patient's temperature hit 104 and she went to the ER. After the CT scan, appendicitis was confirmed and the patient went into an emergency appendectomy. The patient's appendix ruptured. On 09Apr2021, the patient was released from the hospital. As of 28Apr2021, the most of the patient's symptoms are gone but bowel movements are not consistent and stool is soft. The patient's energy level was low and there was slight lower stomach pain at times. The outcome of the events was unknown. No follow-up attempts are needed. No further information is expected.

Other Meds: VYVANSE; DULOXETINE; LAMOTRIGINE

Current Illness:

ID: 1316140
Sex: F
Age:
State: MI

Vax Date: 03/05/2021
Onset Date: 03/27/2021
Rec V Date: 05/14/2021
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Symptoms: diagnosed with COVID/Fever, tiredness, cough; diagnosed with COVID/Fever, tiredness, cough; This is a spontaneous report from a contactable female consumer (patient). A 71-year-old female patient received first dose bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 05Mar2021 (Lot Number: EN6202) at single dose for COVID-19 immunisation. Medical history included type 2 diabetes from 1995 to an unknown date. The patient's concomitant medications were not reported. The patient was questioning the vaccine's efficacy because she had received her 1st dose last 05Mar2021 which was 7 and a half weeks ago. She mentioned that this was because 2 days before her supposed scheduled 2nd dose on 26Mar2021, she started running a temperature and suspected that she was infected by her Husband who had COVID at that time. She was diagnosed with COVID on 27Mar2021. She mentioned that she had a cough that would not go away so that was why she made sure that she had no symptoms before getting her 2nd shot. This past weekend, she mentioned that the cough was not as prevalent as before so she decided to get the shot. She mentioned that the nurse at the facility said that she would still be okay until she mentioned that her 1st shot was on 05Mar2021. She mentioned that her husband was healthier than her that's why he got the 2nd dose 6 and a half weeks after the 1st one. She would like to know if it will be still effective with her. She had been coughing and had a fever. When asked to provide outcome for COVID virus, she stated that she was basically recovered, but was still a little tired. At night time, she starts coughing. She did fine during the day, but she was so much better. She was able to do things. She just has a little bit of a cough. This all started around 5 days into it. Fever started 24Mar2021. It lasted for 13 days and the last day of fever was 05Apr2021. She started coughing 30Mar2021 or 31Mar2021. She later stated it may have been more like 28Mar2021 or 29Mar2021. She will be 72 on Sunday and said she was old and that just comes with being old. She felt ok. The tiredness started time same time as the coughing. She did not feel bad until she started coughing. A couple of days after she was diagnosed was when she started feeling bad. She was able to drive herself to get the test and took a shower and felt ok. She took the test on Friday and found out on Saturday. On Sunday and Monday was when she started coughing. That was when the fever started and it never got over 100.5 degrees. Adverse events (AE) details and time of onset was reported as: positive COVID virus in the morning; cough in the morning; fever in the afternoon; tiredness in the morning. There was no prescriber. She just had it because she was a high risk patient. There were additional vaccines administered on same date of the Pfizer suspect, no prior vaccinations (within 4 weeks), AE following prior vaccination, family medical history and relevant test. The outcome of the events was recovering.

Other Meds:

Current Illness:

ID: 1316141
Sex: F
Age:
State: MA

Vax Date: 03/01/2021
Onset Date: 03/01/2021
Rec V Date: 05/14/2021
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Symptoms: This is a spontaneous report from a contactable consumer (patient's sibling). A currently 65-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on an unspecified date in Mar2021 as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the first Pfizer COVID 19 Vaccine about 6-7 weeks ago (in Mar2021). She has partial kidney function along with diabetes (unspecified onset dates). Two days after the vaccine (in Mar2021) she had an excruciating headache. The following day (in Mar2021), she experienced chills, fever and diarrhea. After several weeks (an unspecified date in 2021), she developed shingles. The clinical outcome of the event "shingles" was not resolved while the outcome of events "partial kidney function along with diabetes", excruciating headache, chills, fever and diarrhea was unknown. The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow-up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021476991 same patient, different dose number and event

Other Meds:

Current Illness:

ID: 1316142
Sex: F
Age:
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Rec V Date: 05/14/2021
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Symptoms: sharp pain in her head; high blood pressure; This is a spontaneous report from a contactable consumer (patient) received via Medical Information Team. A 59-year-old female patient received first dose of 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 and concomitant medications were not reported. The patient reported that she ended in the emergency room (ER) because of a sharp pain in her head and high blood pressure up to 4 days after getting the first dose of vaccine. The patient outcome of the events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

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Current Illness:

ID: 1316143
Sex: F
Age:
State: NJ

Vax Date: 03/14/2021
Onset Date: 04/17/2021
Rec V Date: 05/14/2021
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Symptoms: they packed my nose to stop it from bleeding, clots were coming out, clots coming both ways,; nose bleed; my blood pressure went up; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 14Mar2021 10:00 as 2nd dose ,single for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included acetylsalicylic acid (ASPIRIN BAYER). The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 28Feb2021 for COVID-19 Immunization. The patient received the Second dose of Pfizer on 14Mar2021, states, "On 17Apr2021, Saturday, nose bleed started, and my blood pressure went up. I Called ambulance took blood pressure and it was 210/107. I didn't go to hospital, nose bleed had stopped while they were there, I stayed in ambulance until blood pressure came down. Sunday I went to ER (emergency room) because my nose started bleeding again, it stopped Sunday, but they checked the nose, nothing was there. I stayed in the hotel, Monday morning I blood again, Tuesday I bled even more starting at 7am and it didn't stop. Went to the hospital to ER (emergency room), they packed my nose to stop it from bleeding, clots were coming out, clots coming both ways, they checked blood, not anemic, everything okay with blood. on 23rd they removed the pack from nose, ENT told me no vessels were broken, he said I was fine. That is when I received a phone call about someone else having this problem. A week later a class mate said her sister had the same reaction after getting the Pfizer vaccine." She was calling about the Covid 19 vaccine. She received her second vaccine on 14Mar2021 and had no problems during that time. On 17Apr2021 she called an ambulance because she had a nosebleed. Her blood pressure was also high at that time around 210/107mmHg. Her nosebleed stopped with emergency management technicians and her blood pressure came back down. She did not go to the emergency room at this time. On 18Apr2021 at around 3:00AM, she had another nosebleed and she did go to the emergency department at about 10:00AM. She has never had a nosebleed before. When she was examined in the emergency room on 18Apr2021, she had no blood in her nose that the doctor could see. On 19Apr2021 around 7:00AM she had another nosebleed but the nosebleed stopped and she did not go back to the emergency room. On 20Apr2021, her nose started bleeding around 5:00AM and it didn t stop so she went back to the emergency room around 7:00AM and the doctor in the emergency room packed her left nostril and the blood was coming out of the right nostril and out of her mouth. She was bleeding for a few more minutes and then the bleeding stopped. Her blood pressure was fine. Her bloodwork was checked and everything was fine. She wasn t anemic or anything like that. She didn t have an bad effects from the nosebleeds. The emergency room told her to follow up with her primary care doctor on Thursday, 22Apr2021, but her primary care doctor no longer takes her insurance. She did go see an Ear, Nose, and Throat doctor on Friday, 23Apr2021. The Ear, Nose, and Throat doctor removed the nasal packing and examined the inside of her nose and told her that he could not see any broken vessels or any cause as to why she would be having nosebleeds. The patient's apartment is being renovated and she thought she might be having a reaction to the hotel she s staying in. She moved out of her apartment on 12Apr2021 and her nosebleeds started 17Apr2021. She has missed work because of her nosebleeds and she started back to work this week. When probing for her Covid 19 vaccine information she reports she does not have the vaccine record card with her. She received the second Covid 19 vaccine on 17Mar2021. NDC/Lot/Expiry not known. First Covid 19 vaccine date is in the suspect product field. She does not have the NDC/Lot/Expiry for the first date either. She reports she had a regular physical with her doctor in Nov2020. She received a tetanus vaccine at that visit. She reported she sometimes takes 2-3 regular Bayer Aspirin for minor pain. She took the Bayer Aspirin on Saturday, 17Apr2021, because she was going somewhere and she knew she would be sitting for a while at that place. She would like to report she experienced no discomfort, or aches or pains or headaches with her Covid 19 vaccine. There is no prior Vaccinations (within 4 weeks). The outcome of the events was unknown. Information about lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021476976 same reporter/drug/event, different patient

Other Meds: ASPIRIN BAYER

Current Illness:

ID: 1316144
Sex: F
Age:
State: MO

Vax Date:
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Rec V Date: 05/14/2021
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Symptoms: Bell's Palsy; This is a spontaneous report from a contactable physician. A female patient of unknown age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) on an unknown date in 2021 (reported as a month before this report) as a single dose for Covid-19 immunization. Medical history and concomitant medications were not reported. On an unknown date in 2021 (reported as a month before this report), the patient experienced Bell's palsy. Outcome was unknown. The reporting physician was asking if the second dose is required. Information on the batch number has been requested.; Sender's Comments: Assuming a plausible temporal association, a reasonable possibility that the reported Bell's palsy is related to BNT162B2 vaccine cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified.

Other Meds:

Current Illness:

ID: 1316145
Sex: M
Age:
State: NY

Vax Date: 03/05/2021
Onset Date:
Rec V Date: 05/14/2021
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Symptoms: Positive for COVID; Positive for COVID; Second dose would be administered more than 42 days; Second dose would be administered more than 42 days; This is a spontaneous report received from Medical Information from a contactable pharmacist. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), first dose, via an unspecified route of administration on 05Mar2021 (Batch/Lot number unknown) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications were not reported. The patient received his first dose of the vaccine on 05Mar2021. He tested positive for COVID-19 and received the monoclonal antibodies/ passive antibody therapy on 21Mar2021. The pharmacist inquired if the patient will need to wait 90 days before receiving the second dose of the vaccine. The pharmacist inquired if the patient will need to restart the vaccination over with the second vaccine being about four months out. The second dose would be administered more than 42 days, longer than recommended intervals for mRNA vaccines. The outcome of the events drug ineffective and COVID-19 was unknown. The lot/batch number for the vaccine was not provided and will be requested during follow-up.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Drug ineffective and COVID-19 cannot be totally excluded. The case will be reassessed if additional information becomes available.

Other Meds:

Current Illness:

ID: 1316146
Sex: F
Age:
State: IN

Vax Date: 01/30/2021
Onset Date: 02/01/2021
Rec V Date: 05/14/2021
Hospital: Y

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Symptoms: After first shot began experiencing weakness in legs; fell several times; This is a spontaneous report received from a contactable consumer (the patient). This is the first of 2 reports. A 71-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EL9262) via an unspecified route of administration in left arm on 30Jan2021 at age of 71-year-old at single dose for COVID-19 immunisation. Relevant medical history included COVID-19 from Nov2020 (Was in hospital with COVID in November. Did well in December and January). Other medical history reported as "none". No known allergies. Concomitant medications (received within 2 weeks of vaccination) included bupropion taken for an unspecified indication from an unspecified date; clonazepam taken for an unspecified indication from an unspecified date and "Celebs" (as reported). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had not been tested for COVID-19 since the vaccination. After first shot began experiencing weakness in legs and fell several times. The events onset date was 01Feb2021. "Steroids" was received for the event "weakness in legs". CT scans of entire spine and brain with unknown result. The events resulted in Doctor or other healthcare professional office/clinic visit, Hospitalization (for 23 days), Disability or permanent damage. The outcome of the events was not recovered.; Sender's Comments: Linked Report(s) :PFIZER INC-2021531421 same patient/reporter/drug, different AE in separated time

Other Meds: BUPROPION; CLONAZEPAM

Current Illness:

ID: 1316147
Sex: M
Age:
State:

Vax Date: 04/19/2021
Onset Date: 04/25/2021
Rec V Date: 05/14/2021
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Symptoms: he had an episode which he states is similar to a TIA (transient ischemic attack); Reports experiencing something similar last may except for 'the paralysis'.; numbness, pain and tightness in his lower half of his body which was more prominently felt on his left side.; numbness, pain and tightness in his lower half of his body which was more prominently felt on his left side.; numbness, pain and tightness in his lower half of his body which was more prominently felt on his left side.; States he felt as though his knee had a tear in it- it felt it was on fire; tightness in left knee; shortness of breath; feeling foggy; headache; balance issue; coordination off; having a hard time to get a sentence out (felt like his motor skills were affected); having a hard time to get a sentence out (felt like his motor skills were affected); confusion; blurred vision; impending sense of doom; post fatigue; his energy doesnt feel up to par; This is a spontaneous report from a contactable consumer (patient) reported for himself. A 28-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 19Apr2021 at 28 years old (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient stated that on 19Apr, he had the first shot of pfizer covid vaccine. This past sunday (25Apr2021), he had an episode which he stated was similar to a TIA (transient ischemic attack). Reported numbness, pain and tightness in his lower half of his body which was more prominently felt on his left side. Stated he felt as though his knee had a tear in it- it felt it was on fire; he experienced burning and tightness in left knee. He also reported having shortness of breath, headache, feeling foggy, balance issue, coordination off, having a hard time to get a sentence out (felt like his motor skills were affected), confusion, blurred vision and an impending sense of doom. Stated this episode persisted for 15 min and then it resolved. Currently he was experiencing a 'post fatigue' and his energy didn't feel up to par. Reported experiencing something similar last may except for 'the paralysis'. Had not followed up with his provider. Patient was scheduled for second shot of Pfizer covid vaccine on 10May, he was asking for information if he decided to delay his second shot past may 10th. He was asking for information on getting the second shot given his recent experience possibly related to the vaccine shot. Was not sure if he should get the second shot. He was asking about side effects for the second shot- if it would be worse. Asking if there were any reports of blood clots with Pfizer covid vaccine. The outcome of the events 'post fatigue' and "his energy didn't feel up to par" was unknown, of other events was recovered on 25Apr2021. Information about lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1316148
Sex: M
Age:
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Rec V Date: 05/14/2021
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Symptoms: He felt like he was getting Covid again; A slight fever; Stomach was bothering him; Appetite wasn't there; mental trauma; after receiving the vaccine it went into his hips; This is a spontaneous report received from a contactable consumer (patient). A 62-years-old male patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization. Medical history included hip problems (bone on bone on both hips-scheduled surgery for 11June2021), pulmonary embolism from Feb2021 to an unknown date (hospitalized for three days due to a pulmonary embolism) ,Covid-19 from Feb2021 to an unknown date (in February he tested positive for Covid) The patient's concomitant medications were not reported. The patient experienced he felt like he was getting covid again, a slight fever, stomach was bothering him, appetite wasn't there, mental trauma, bone on bone on both hips. he feels like when he got covid it went into his hips and after receiving the vaccine. The patient underwent lab tests and procedures which included sars-cov-1 test: positive on Feb2021. The clinical course was reported as follows Male patient aged 62, received first dose of the Pfizer BioNTech Covid 19 vaccine approximately 3 weeks ago (date unspecified) from his place of employment. In February he tested positive for Covid and was hospitalized for three days due to a pulmonary embolism. Two days after receiving his first dose of the vaccine, he started developing symptoms, he felt like he was getting Covid again. He experienced a slight fever, stomach was bothering him, appetite wasn't there and it took two weeks to recover. 'He has hip problems, bone on bone on both hips. He feels like when he got Covid it went into his hips and after receiving the vaccine it went into his hips'. He has a scheduled surgery for 11June2021. He reports mental trauma from having covid and when he got side effects from the vaccine it felt like he was getting Covid all over again. Callers wife inquired Can you wait six weeks to get second dose? Caller inquired Does he have to get his second dose of the vaccine or does he have enough coverage from having covid and having the first dose? The clinical outcome of the event after receiving the vaccine it went into his hips was unknown while the remaining events was recovered. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1316149
Sex: M
Age:
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Rec V Date: 05/14/2021
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Symptoms: The patient received dose 1 of Pfizer vaccine on an unspecified date (also reported as around 10 weeks ago) and the patient contracted COVID; The patient received dose 1 of Pfizer vaccine on an unspecified date (also reported as around 10 weeks ago) and the patient contracted COVID; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (also reported as around 10 weeks ago) (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient received dose 1 of Pfizer vaccine on an unspecified date (also reported as around 10 weeks ago) and the patient contracted COVID on an unspecified date (for clarification). The patient underwent Covid-19 test and became negative on an unspecified date (reported as 2 1/2 weeks ago). The outcome of the event was recovered on an unspecified date. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1316150
Sex: F
Age:
State:

Vax Date: 03/30/2021
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Rec V Date: 05/14/2021
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Symptoms: some nerve issues, hands and feet; tinnitus; This is a spontaneous report from a non-contactable consumer, the patient. A female patient of an unspecified age received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 30Mar2021 (Batch/Lot number was not reported) as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient saw her neurologist and reported tinnitus on an unspecified date, it stayed the same as she reported it. Her neurologist that she saw at 7:30 this morning. They were going to do nerve testing. He wanted her to hold off on getting the second dose. He said that it's 80% efficacy. She had already gone past 4 weeks and he said that she could wait longer. She was having some nerve issues, hands and feet, nothing to do with the vaccine as they didn't think so. He didn't think it's related to the vaccine. He told her that she didn't have to get it right away because he said that it was 80% now, from reports that they heard. The patient wanted to know the timing information on the second dose and what was the efficacy of one dose. The patient stated that she would definitely be getting it past 42 days, not even know if I was going to get the second dose. The outcome of events, some nerve issues, hands and feet and tinnitus was unknown. The patient stated that her husband was a superintendent and he talked to health department once week. No follow-up attempts are possible, information about lot/batch number cannot be obtained.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of Neuropathy peripheral and tinnitus due to temporal relationship. However, the reported events may possibly represent intercurrent medical conditions in this patient. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Other Meds:

Current Illness:

ID: 1316151
Sex: F
Age:
State: FL

Vax Date: 12/19/2020
Onset Date: 01/08/2021
Rec V Date: 05/14/2021
Hospital: Y

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Symptoms: This is a spontaneous report from a contactable other HCP (healthcare professional), the patient. A 72-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot Number: E11283) via an unspecified route of administration on 19Dec2021 at 12:00 (at the age of 72-years-old) as a single dose for COVID-19 immunisation. Medical history included "HTH GERD" and sulfa allergy, both from unspecified dates and unspecified if ongoing Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications (received within two weeks of the vaccination) included pantoprazole sodium sesquihydrate (PROTONIX), losartan and anastrazole, all taken for unspecified indications on unspecified dates. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient previously received demerol for an unspecified indication on an unspecified date and experienced allergy (reported as "known allergies: Eli sulfa demerol"). On 08Jan2021 at 12:00 the patient experienced severe cellulitis on trunk anterior/ posterior, elevated temp white count pain, fatigue, SOB (shortness of breath) and chest pain. All events were serious for hospitalization on an unspecified date, for 5 days. All events resulted in a doctor or other healthcare professional office/clinic visit and an emergency room/department or urgent care visit. The events required treatment with antibiotics for 6 weeks. The clinical outcomes of the events severe cellulitis on trunk anterior/ posterior, elevated temp white count pain, fatigue, SOB (shortness of breath) and chest pain were all recovered/resolved with sequel (recovered with lasting effects) on an unspecified date. Since the vaccination, the patient had not been tested for COVID-19. Information on Lot/Batch number was available. Additional information has been requested.; Sender's Comments: Based on the information available the reported events more likely represent intercurrent medical conditions that were unlikely related to BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE). 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: PROTONIX [PANTOPRAZOLE SODIUM SESQUIHYDRATE]; LOSARTAN; ANASTROZOLE

Current Illness:

ID: 1316152
Sex: F
Age:
State: NJ

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Rec V Date: 05/14/2021
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Symptoms: clots were coming out; nose bleed; blood pressure went up; This is a spontaneous report from a contactable consumer (classmate's sister). This is the second of two reports. A 62-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection) via an unspecified route of administration on an unspecified date (at an unspecified age) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection) via an unspecified route of administration on an unspecified date (at an unspecified age) as a single dose for COVID-19 immunization. On an unspecified date (almost a month after receiving the second COVID-19 vaccine) the patient experienced clots were coming out, nosebleed and blood pressure went up. The reporter called to report that she had received a phone call from an old classmate, who had a sister, who experienced the same reaction after getting the Pfizer vaccine. This patient experienced the same nosebleeds after the COVID-19 vaccine. This person's nosebleeds started almost a month after she received the second dose of the COVID-19 vaccine. That was when the reporter started trying to figure out where these nosebleeds were coming from. She did not have any further information on the person that she mentioned. The clinical outcomes of the events clots were coming out, nosebleed and blood pressure went up were unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021476256 same reporter/drug/event, different patient

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Current Illness:

ID: 1316154
Sex: F
Age:
State: IL

Vax Date: 04/08/2021
Onset Date: 04/23/2021
Rec V Date: 05/14/2021
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Symptoms: bleeding heavily with small clots; has not had menstrual cycle since 2018; started spotting; bleeding heavily with small clots; This is a spontaneous report from a contactable consumer, the patient. This 51-year-old (non-pregnant) female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727), via an unspecified route of administration in the right arm on 08Apr2021 11:30 (at the age of 51-year-old) as a single dose for COVID-19 immunization. Medical history included endometriosis diagnosed in 1993 and subsequently she had laparoscopy twice by the age of 26-year-old; and ongoing menopause since 2018. History of Parity 1: the patient was pregnant with her daughter and have her naturally at 27 years old and never had another pregnancy again. The patient's concomitant medications were only women multi-vitamins. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient reported that she has not had menstrual cycle since 2018. On 23Apr2021, the patient started spotting. Since 26Apr2021, she has been bleeding heavily with small clots. All day today (on 28Apr2021) she has been bleeding very very heavy with clots. She was planning to go to her doctor by morning, but she was following through with her second dose tomorrow (29Apr2021). The clinical outcome of the events "have not had menstrual cycle since 2018; started spotting; bleeding heavily with small clots" were not resolved. The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow-up.

Other Meds:

Current Illness: Menopausal

ID: 1316155
Sex: F
Age:
State: MI

Vax Date:
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Rec V Date: 05/14/2021
Hospital: Y

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Symptoms: This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (Patient's relative) reported for a female patient of an unspecified age received BNT162B2 (PFIZER COVID 19 VACCINE, Lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date at unknown dose number, single for COVID-19 immunization. The patient's medical history and concomitant medication were not reported. The patient received the Pfizer Covid vaccine. The patient was fine and healthy after the shot. Subsequently she fell down, hurt her hip and broke her wrist. Last Monday, she went for a steroid shot that was given in her wrist. On Tuesday, she was flushed and threw up. They took her to the hospital, and she was diagnosed with blood clots in her brain. She has been in the hospital since that Tuesday (unspecified date) due to the reported events. She has since been admitted to the hospital with a swelling of her brain, and confusion. The events happened on unspecified dates. She is scheduled for a magnetic resonance imaging (MRI). The outcome of the events was unknown. Information on the batch number has been requested.

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Current Illness:

ID: 1316156
Sex: M
Age:
State: PA

Vax Date: 01/22/2021
Onset Date:
Rec V Date: 05/14/2021
Hospital: Y

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Symptoms: resulted into blood clots in his throat and left side of his body; This is a spontaneous report from a contactable consumer via a Pfizer sponsored program. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose on 22Jan2021 (Batch/Lot Number: EL1283) as 1st dose, single, second dose on 16Feb2021 (Batch/Lot Number: EL9264) as 2nd dose, single; both via an unspecified route of administration for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient reported that he ended up in the hospital after receiving both covid vaccines which resulted into blood clots in his throat and left side of his body from the waist down on an unspecified date. The patient was hospitalized due to the event from 25Apr2021 to 27Apr2021. The outcome of the event was unknown.

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Current Illness:

ID: 1316157
Sex: F
Age:
State:

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Rec V Date: 05/14/2021
Hospital: Y

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Symptoms: they were concerned about blood clot; shaking uncontrollably; pouring sweat; sheet white with no color to skin at all; blood pressure 68/30; not particularly coherent; This is a spontaneous report received from a contactable consumer (patient's husband). A female patient of unspecified age received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via an unspecified route on an unspecified date as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The reporter stated his wife had adverse event to the COVID vaccine last week. He stated that they both got the vaccine. At 3 AM on unspecified date, the reporter woke up because his wife (patient) was shaking uncontrollably, pouring sweat, sheet white no color to skin at all, not particularly coherent and had blood pressure 68/30. They had to call an ambulance and she was brought to the hospital. They were able to get her blood pressure up and stabilized her after 8 hours. They were concerned about blood clot and did other scans. Lab data included blood pressure 68/30 (units unspecified) and scans with unknown results; both on unspecified date. The clinical outcomes of shaking uncontrollably, pouring sweat, sheet white no color to skin at all, not particularly coherent and blood clot were unknown, while of blood pressure 68/30 was recovering. The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1316158
Sex: F
Age:
State: IL

Vax Date: 04/23/2021
Onset Date: 04/25/2021
Rec V Date: 05/14/2021
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Symptoms: This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in left arm on 23Apr2021 01:00 (Batch/Lot Number: EW0164) (at the age of 48 years old) at 1st dose, single for COVID-19 immunization. Medical history included low iron, Bell's palsy in Jan2020 and patient had no known allergies. The patient was not pregnant at time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications within 2 weeks of vaccination. On 25Apr2021 08:00 (after receiving the vaccine 2 days later), the patient had Bells Palsy symptoms started along with a head ache. The adverse event resulted in doctor or other healthcare professional office/clinic visit. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had been tested for COVID-19. The outcome of the events was not recovered.

Other Meds:

Current Illness:

ID: 1316159
Sex: M
Age:
State: FL

Vax Date: 04/06/2021
Onset Date: 04/06/2021
Rec V Date: 05/14/2021
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Symptoms: Cellulitis; immune system being weakened; fevers which came and went; chills; sweats; nausea; loss of appetite; light headedness; lack of energy; This is a spontaneous report from a contactable consumer (the patient). A 36-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0151) via an unspecified route of administration in left arm on 06Apr2021 12:30 at age of 36-year-old at single dose for COVID-19 immunisation. The patient had no relevant medical history. No known allergies. The patient's concomitant medications were not reported. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN6205) via an unspecified route of administration in left arm from 16Mar2021 12:30 at age of 36-year-old for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. The patient did not diagnose with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. The patient was very sick for 4 days: fevers which came and went, chills, sweats, nausea, loss of appetite, light headedness, lack of energy. As a result of his immune system being weakened, he wound up with Cellulitis which he was still fighting over 3 weeks after the shot. As the patient was normally a healthy male, it was strange that he would wind up with a bacterial infection. The patient also stated that after the second dose he experienced cellulitis in his left leg to thigh area. He went to emergency room for scan and to rule out clot. He thought he was immunocompromised and that was why he got the cellulitis in the leg. Caller wanted to get the compensation information to help with the bills. The events onset date was 06Apr2021 17:00. 2 rounds of antibiotics was received for the events. The events result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient underwent lab tests and procedures which included ultrasound with unknown result. The outcome of the events was recovering.

Other Meds:

Current Illness:

ID: 1316160
Sex: F
Age:
State: PA

Vax Date: 03/03/2021
Onset Date: 03/04/2021
Rec V Date: 05/14/2021
Hospital: Y

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Symptoms: left hand was edematous and cold; left hand was edematous and cold; left hand pain; blood clot; swollen submandibular gland that got bigger/could feel her mouth getting bigger; ill with something not related to the vaccine; This is a spontaneous report from a contactable nurse (patient) via Medical information team. A 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 intramuscular, administered in Arm Left on 03Mar2021 15:00 (Lot Number: EN6201) as 1ST DOSE, SINGLE for COVID-19 immunization. Medical history included stroke on 2007, COVID-19 from an unknown date and unknown if ongoing. Concomitant medications included clopidogrel bisulfate (PLAVIX) taken for stroke from 2007 to an unspecified stop date; and acetylsalicylic acid (ASPIRIN (E.C.)) taken for stroke from 2007 to an unspecified stop date. The next day on 04Mar2021, the patient had a swollen submandibular gland that got bigger. She could feel her mouth getting bigger. The patient was admitted into the hospital on 07Mar2021 and released on 09Mar2021. She was readmitted to the hospital on 11Mar2021 until 18Mar2021. The patient went back into the hospital on 21Mar2021 and released 20Apr2021. The gland was removed on 13Apr2021. She developed a blood clot. She went to the emergency room and was sent home on Xarelto. The patient mentioned that she received the 1st dose of the vaccine on 03Mar2021 and came down ill with something not related to the vaccine. She was hospitalized for 4 weeks and ended up missing her 2nd dose appointment on 24/Mar/2021. She would like to get her 2nd dose but she is now 5 weeks overdue for it. She mentioned the hospital is recommending that she restart her vaccination. She is looking for guidance from Pfizer. The facility where the most recent COVID-19 vaccine was administered was in the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient underwent had CT and MRI of left arm/wrist which she does not have results to provide. Event relatedness to vaccine was unknown for events, swollen submandibular gland that got bigger, left hand was edematous and cold, left hand pain and blood clot. The outcome of the event blood clot swollen submandibular gland was recovered with sequel on unspecified date, the outcome of ill feeling was unknown and the outcome of the rest of the events was recovering.; Sender's Comments: The 67-year-old female patient had medical history of stroke. Based on information available, the reported thrombosis and other events were unlikely related to the vaccine of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE). This case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Other Meds: PLAVIX; ASPIRIN (E.C.)

Current Illness:

ID: 1316161
Sex: F
Age:
State:

Vax Date: 03/04/2021
Onset Date:
Rec V Date: 05/14/2021
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Symptoms: diagnosed her with inflammatory breast cancer; experienced chills and such that started in the middle of the night; a week after having that Pfizer vaccine she started noticing bruising on her right breast and there was swelling; a week after having that Pfizer vaccine she started noticing bruising on her right breast and there was swelling; This is a spontaneous report a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration in the left arm on 04Mar2021 (Lot number: UNKNOWN) as single dose for COVID-19 immunisation. Medical history included ovarian cancer (12 years ago and she survived). Concomitant medication included ibuprofen. The patient reported after 1st dose she was diagnosed her with inflammatory breast cancer. The patient experienced chills and such that started in the middle of the night. She had no real aches and pains in that first couple of days. The patient reported that a week after having that Pfizer vaccine she started noticing bruising on her right breast and there was swelling. She noticed some unusual things happening with her breast and at first she thought that she didn't know if it was from the COVID vaccine or if maybe she had hit something. But within a week or two she had severe breast swelling and noticed other bruising. After that first COVID vaccine she thought that it was an unusual thing that happened so she called her doctor and they have now diagnosed her with inflammatory breast cancer which comes up quickly and can't always be diagnosed on a mammogram. It wasn't with a lump that they decided to see if she had this, it was because of the swelling and bruising. The doctor said well it could be coincidental with the COVID vaccine but it is awfully strange that this came up shortly after the first vaccine. The clinical outcome of the events was unknown. Information on the lot/batch number has been requested.

Other Meds: IBUPROFEN

Current Illness:

ID: 1316162
Sex: F
Age:
State: VA

Vax Date: 04/26/2021
Onset Date: 04/26/2021
Rec V Date: 05/14/2021
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Symptoms: bursts of energy; headache; Chills; Panic attack; Panic attack; Hyperventilation; seeing green; feeling faint / dizzy; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: EN6206), via an unspecified route of administration in the right arm on 26Apr2021 at 08:45 (at the age of 54-years-old) as a single dose for COVID-19 immunization. Medical history included ductal carcinoma in situ (DCIS), asthma from 5 years old, calcification of the breast, vitamin D deficiency, "keep immune system up", ongoing panic and anxiety disorder. Concomitant medications included ascorbic acid/calcium carbonate/calcium pantothenate/calcium phosphate/chromium/cyanocobalamin/folic acid/magnesium carbonate/ magnesium hydroxide/manganese gluconate/nicotinic acid/potassium bicarbonate/potassium carbonate/potassium phosphate dibasic/pyridoxine hydrochloride/quercetin/riboflavin sodium phosphate/sodium bicarbonate/sodium phosphate/thiamine hydrochloride/thioctic acid/zinc ascorbate (EMERGEN-C) to keep immune system up and colecalciferol (D3) for vitamin D deficiency. The patient did not receive any other vaccinations within 4 weeks of the vaccine. On 26Apr2021, right after the vaccination, the patient felt a little dizzy but proceeded to her car anyway, got about half a mile away and felt extreme panic. On 26Apr2021 at 09:35, the patient had a major panic attack (which the patient gets, "but it had to be something really big"). She began hyperventilating on 26Apr2021, felt like she was going to faint. She pulled over and started breathing in her hands until she felt almost normal; the anxiety didn't go away, but that was normal for her. Then the faintness came back, and she pulled over again; mentioned she was in heavy traffic and hurried up to pull over. Eventually she contacted her son and he came and took over the wheel. This happened three times on her 45-minute drive; at 15 minutes, then 10 minutes and then at 9 or 8 minutes. She stated she had nothing to eat or drink before the vaccine and they didn't advise her to get anything to eat or drink and that may have had something to do with it. She could see everything looking greenish and it was a sunny day outside. She had a bottle of water and started to drink, and it subsided for a little bit. She pulled over and sat for 15 minutes; there were trucks and cars going really fast; she was doing self-talk saying you can do this and get home; then she drove about 10 or 15 more minutes; she had stayed on the side so she could pull over; cars honked at her for going so slow and she pulled over again. It happened again after 20 minutes. She was feeling really funny. Her son took her for coffee and something to eat. Throughout the day she was having hyperventilation and anxiety feelings until about 19:30 it went away. She had a good night's rest. On 27Apr2021 in the evening, the patient experienced chills so she put on socks; and she had a headache (she never had headaches), so she went to bed. Then she woke up at midnight and felt really energetic, so she watched a little TV then went back to sleep. Now it was day three and she had a lot of bursts of energy. This morning, 28Apr2021, she had a burst of energy and felt renewed. The events did not require a visit to the physician office or emergency room. The clinical outcome of feeling faint and seeing green was resolved on 26Apr2021; of dizzy, headache, and chills was resolved on 27Apr2021; of panic attack and hyperventilation was not resolved; of bursts of energy was unknown. Information on batch number has been requested

Other Meds: EMERGEN C; D3

Current Illness: Anxiety disorder; Panic disorder

ID: 1316163
Sex: M
Age:
State: CA

Vax Date: 04/28/2021
Onset Date: 04/28/2021
Rec V Date: 05/14/2021
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Symptoms: Seizure; Felt dizzy; Eye sight was blurry; Shake and jerk; Shake and jerk; Skin turned pale; Heart rate was high; Nauseous; This is a spontaneous report from a contactable consumer. A 17-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 28Apr2021 16:00 as unknown, single for covid-19 immunisation. The patient medical history was not reported. Concomitant medications included fish oil; magnesium [magnesium citrate]; vitamin d [vitamin d nos]; probiotic [bifidobacterium lactis]; vitamin b complex (VITAMIN B). The consumer stated, approximately 20 minutes after receiving the vaccine (28Apr2021 16:15) the patient felt dizzy, eyesight was blurry, and he began to shake and jerk. It resembled a seizure. His skin turned pale, heart rate was high, and he felt nauseous. It took him approximately 5-10 minutes to feel "normal" again. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The adverse event result in emergency room/department or urgent care. There is no treatment for AE. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was resolving. Information about Batch/Lot no. has been requested.

Other Meds: FISH OIL; MAGNESIUM [MAGNESIUM CITRATE]; VITAMIN D [VITAMIN D NOS]; PROBIOTIC [BIFIDOBACTERIUM LACTIS]; VITAMIN B

Current Illness:

ID: 1316164
Sex: F
Age:
State: NY

Vax Date: 04/06/2021
Onset Date: 04/01/2021
Rec V Date: 05/14/2021
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Symptoms: site of where she got injected got infected and she was diagnosed with Cellulitis/ arm pain; rash is mostly on her shin, on that part of her body, and goes up her leg. It is like little raised bumps; injection site itchy; scratching so much like she would scratch her skin off; scratching so much like she would scratch her skin off; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration (at the age of 49-years-old), administered in Arm Left on 06Apr2021 12:00 (Batch/Lot Number: Unknown) as 1st dose, single for COVID-19 immunization. Medical history included cellulitis from a bug bite in a different location. The patient's concomitant medications were not reported. The patient initially stated she had an allergic reaction, then clarified to reaction. She had this reaction three weeks to the date of the first shot. She had to go Urgent Care. The site of where she got injected got infected and she was diagnosed with Cellulitis. Her injection site is all red and infected, it is like a rash there. She further explained she is unsure if this is an allergic reaction, but she has a rash, it is itchy. Her injection site is tender, itchy, warm, and red. She was given antibiotics to take. She does not have her primary care doctors address to provide at time of call. She further clarified today is like the 3rd or 4th day of having a rash, later clarified the start as 24Apr2021. The rash is mostly on her shin, on that part of her body, and goes up her leg. It is like little raised bumps. In the middle of the night she found herself scratching so much like she would scratch her skin off. The rash on her arm feels different. There is site pain there, but it also itches. It feels hard like she just got the shot in the arm. She feels like she wants to scratch and there are bumps there. Time of onset of rash in arm was started mid-afternoon. The arm pain started as clarified 26Apr2021. She confirmed she still feels the arm pain. It is bothersome. She wants to itch it. She does not think it is has gotten worse. However, she just started the antibiotics. Time of onset of arm pain was middle of the night. She went to urgent care yesterday and was officially diagnosed with cellulitis yesterday, 27Apr2021. Treatment included an antibiotic and antihistamine, but she does not have the name to provide. She scheduled an appointment to see the doctor when she gets back home. Sure he will do testing/blood work. The outcome of the events was unknown. The event "site of where she got injected got infected and she was diagnosed with Cellulitis" was considered as serious (medically significant). No history of all previous immunizations with the Pfizer vaccine considered as suspect. No additional vaccines administered on same date of the Pfizer suspect. She was supposed to get the second shot yesterday, but she did not due to everything going on. She wants to know if she should see her doctor before getting the second vaccination. She stated she is not comfortable with getting the second dose. If she wanted to get the second dose wanted to know what the window of opportunity was to get the second dose. Information on the lot/batch number has been requested.

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Current Illness:

ID: 1316165
Sex: F
Age:
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Vax Date: 04/23/2021
Onset Date: 04/24/2021
Rec V Date: 05/14/2021
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Symptoms: 12 hours post vaccination blacked out. Post regaining consciousness both hands and arms became numb; Mild migrane; Forehead felt numb for 3 d/Post regaining consciousness both hands and arms became numb; slight tingling in fingers; This is a spontaneous report from a non-contactable other hcp (patient). A 29-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 23Apr2021 19:00 as single dose for covid-19 immunisation. Medical history was reported as none. The patient's concomitant medications were not reported. The patient felt okay after vaccine. 12 hours post vaccination (24Apr2021 08:00) blacked out. Post regaining consciousness both hands and arms became numb. Felt slight tingling in fingers. Mild migrane. Forehead felt numb for 3 days. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There is no list of any other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. There is no known allergies and other medical history. The outcome of the events was resolving. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: The causal association cannot be excluded between the reported event of Loss of consciousness and BNT162B2. The impact of this report on the benefit-risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for AE. 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.

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Total 2021 VAERS Injuries: 674,568

Page last modified: 03 October 2021 5:28pm