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
88,334
AK1,815
AL6,133
AR3,993
AS45
AZ14,539
CA64,759
CO12,159
CT8,719
DC1,747
DE1,868
FL41,499
FM3
GA16,132
GU92
HI2,477
IA4,739
ID2,763
IL21,496
IN23,655
KS4,844
KY8,414
LA5,328
MA15,281
MD13,105
ME3,277
MH8
MI20,143
MN12,873
MO10,275
MP30
MS3,073
MT2,392
NC17,450
ND1,440
NE3,023
NH3,124
NJ19,456
NM4,089
NV4,600
NY36,525
OH20,140
OK6,525
OR8,918
PA24,920
PR2,483
QM2
RI2,092
SC6,952
SD1,243
TN10,038
TX38,745
UT4,482
VA15,477
VI62
VT1,780
WA15,487
WI11,573
WV2,461
WY894
XB5
XL1
XV2

ID: 1405793
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 06/17/2021
Hospital:

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Symptoms: Patient received the first dose of the covid vaccine, and experienced paralysis on the side of her cheek, and then it went away the next day.; This is a spontaneous report from a Pfizer sponsored program via a contactable consumer. A female patient (reporter's daughter) of an unspecified age (reported as in her late twenties) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included patient was healthy, patient only takes birth control from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Patient received the first dose of the COVID vaccine, and experienced paralysis on the side of her cheek, and then it went away the next day. Outcome of the event was recovered.

Other Meds:

Current Illness:

ID: 1405794
Sex: F
Age:
State: OK

Vax Date: 05/24/2021
Onset Date: 05/25/2021
Rec V Date: 06/17/2021
Hospital: Y

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Symptoms: right leg, arm, and cheek felt strange; Slight tingling in face which spread throughout out body/ One week after woke up to right hand asleep/pins and needles; This is a spontaneous report from a contactable consumer (patient). A 33-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in Arm Left on 24May2021 11:30 (Batch/Lot number was not reported) as 1st dose, single dose for covid-19 immunisation. Not pregnant at time of vaccination. No other vaccine in four weeks. Medical history included insomnia, Penicillin allergy, Liquid IV Contrast allergy. No COVID prior vaccination. Concomitant medications included ibuprofen; zaleplon. The patient experienced slight tingling in face which spread throughout out body beginning one day after receiving 1st dose on 25May2021 08:00. One week after woke up to right hand asleep/pins and needles and right leg, arm, and cheek felt strange. The events resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization with duration of 1 day. The patient underwent lab tests and procedures which included Nasal Swab: negative on 31May2021. Outcome of the events was unknown. Information on the lot/batch number has been requested.

Other Meds: IBUPROFEN; ZALEPLON

Current Illness:

ID: 1405795
Sex: M
Age:
State: IL

Vax Date: 03/18/2021
Onset Date: 03/18/2021
Rec V Date: 06/17/2021
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Symptoms: He came home that night and had sore arm and he was flushed in the face; He came home that night and had sore arm and he was flushed in the face; This is a spontaneous report from a contactable consumer. A 66-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Lot Number: ER2631; Expiration Date: 31Jul2021), dose 1 via an unspecified route of administration, administered in left arm on 18Mar2021 at 09:30 as 1st dose, single dose for COVID-19 immunization.Medical history included intervertebral disc protrusion (Back and neck herniated) from 2014, ligament injury (2 knees going out, 2 surgeries by scope on both knees) from 2012 , knee operation (2 knees going out, 2 surgeries by scope on both knees) in 2012 , rotator cuff syndrome (Rotator cuffs left and right) from 2016 , wrist surgery(Bicep and left wrist surgery) in 2000 , surgery (Bicep and left wrist surgery) in 2000 , ongoing blood pressure measurement (Had for 5 years). Concomitant medications received within 2 weeks of vaccination included tramadol (TRAMADOL) 50mg taken for ligament injury, intervertebral disc protrusion, rotator cuff repair taking from over 10 years and losartan (LOSARTAN) 100-12.5mg taken for blood pressure measurement from 5 years.It was unknown Since the vaccination, if patient has been tested for COVID-19. It was unknown if patient was diagnosed with COVID-19.Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.The patient underwent lab tests and procedures which included on 14May2021, blood test seem to be fine ,chest x-ray,magnetic resonance imaging and electrocardiogram were negative, on 22May2021blood test seem to be fine, on 22May2021 electrocardiogram was negative and SARS-CoV-2 antibody test was negative. On 18Mar2021, patient experienced sore arm and flushed face. It was reported that patient came home that night and had sore arm and he was flushed in the face. The outcome of event sore arm resolved in 2021 and out of flushed face was resolving. Information on Lot/Batch number was available. Additional information has been requested.

Other Meds: TRAMADOL; LOSARTAN

Current Illness: Blood pressure (Had for 5 years); Herniated disc (Back and neck herniated); Knee ligament injury (2 knees going out, 2 surgeries by scope on both knees); Rotator cuff injury (Rotator cuffs left and right)

ID: 1405796
Sex: F
Age:
State: CA

Vax Date: 05/27/2021
Onset Date: 05/28/2021
Rec V Date: 06/17/2021
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Symptoms: Entire body is covered in huge hives and rashes/hives and rashes were all over my thighs, hips, stomach, back, legs, arms, neck; Entire body is covered in huge hives and rashes/hives and rashes were all over my thighs, hips, stomach, back, legs, arms, neck; Feel extremely hot; Had trouble sleeping; itchy on her head/itchiness spread throughout my body/itchy on my head, neck and ears; Feel feverish; This is a spontaneous report from a contactable consumer (patient herself). A non-pregnant 30-year-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in left arm, at age 30-years, on 27May2021 18:30 (Batch/Lot Number: EW0185) as 2ND DOSE, SINGLE DOSE for COVID-19 immunisation. Medical history included herpes simplex virus 1, beta thalassemia, allergy to green onion, white onion, leeks, garlic, wheat, mangoes and chemical sunscreens. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not receive any other medications within 2 weeks of vaccination. The patient historically received first dose of BNT162B2 (Batch/lot number: EW0172), on the left arm at age 30 years on 06May2021 06:30 PM for COVID-19 immunisation. On Friday 28May2021, patient started to feel feverish around 11AM and that last until Saturday evening. Saturday night 29May2021 23:45, patient began to feel extremely hot and itchy on her head, neck and ears. She also had trouble sleeping because the itchiness spread throughout her body. She woke up Sunday morning 30May2021 and discovered that her entire body was covered in huge hives and rashes. The hives and rashes were all over her thighs, hips, stomach, back, legs, arms, neck. She tried taking BENADRYL all day Sunday but on Monday evening, 31May2021 the hives started spreading more to new places: a huge circle patch in between her chest, on the sides of her ribs, under her armpits, the size of a pancake-shaped hive on her neck and collarbone, pancake-shaped hive on the back of her tail bone, on her buttocks, as well as hives spreading down to the right arm and hand. This Tuesday morning 01Jun2021, patient woke up and find the hives were in new places on her body: many large hives splotches on her shins and calves. Since the vaccination, the patient has not been tested for COVID-19. Facility where the most recent COVID-19 vaccine was administered was other. The outcome of the event feel feverish was recovered on 29May2021, while for the other events, it was not recovered.

Other Meds:

Current Illness:

ID: 1405797
Sex: M
Age:
State: MO

Vax Date: 05/15/2021
Onset Date: 05/15/2021
Rec V Date: 06/17/2021
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Symptoms: throat swelling; numbness in knees and feet; numbness in knees and feet; This is a spontaneous report from a contactable consumer (patient mother). A 15-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) at 15-years-old, dose 1 via an unspecified route of administration, administered in Arm Left on 15May2021 11:38 (Batch/Lot Number: EW0173) as 1ST DOSE, SINGLE DOSE for covid-19 immunisation. Medical history included asthma. Vaccination Facility Type: Pharmacy. No history of previous immunization with the Pfizer vaccine considered as suspect. No additional Vaccines Administered on Same Date of the Pfizer Suspect. Additional Information for Other Conditions: consumer stated that patient had probably mostly grown out of it. Patient was diagnosed whenever he was three years old. The patient's concomitant medications were not reported. The patient received first dose of vaccine and experienced throat swelling (his throat closed up a little bit), numbness in knees and feet about 12 minutes after vaccine on 15May2021 11:50 with outcome of recovered in 15May2021. Therapeutic measures were taken as a result of throat swelling, it recovered completely after patient took Benadryl. No investigation assessment. The events did not require a visit to: Emergency Room or Physician Office. They gave patient Benadryl there, and told reporter if patient has anymore issues to take him to the emergency room. No prior Vaccinations within 4 weeks. the consumer wanted to see if patient should get the second dose of the covid vaccine, was also going to check with patient's doctor.

Other Meds:

Current Illness:

ID: 1405798
Sex: F
Age:
State: CO

Vax Date:
Onset Date:
Rec V Date: 06/17/2021
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Symptoms: Headache; nausea; loss of smell; congestion; runny nose; cough; body aches; I feel sometime hot sometime I feel chill; I feel sometime hot sometime I feel chill; feel cold; Back pain; This is a spontaneous report from a contactable consumer (patient). A 35-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot Number: EW0187), at same age, as 2ND DOSE, SINGLE DOSE for covid-19 immunisation. Medical history includes coronavirus infection. The patient concomitant medications were not reported. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EW0167), for covid-19 immunisation. Patient was experiencing symptoms like she did when she previously had the coronavirus infection and wanted to know if it could be side effects of the vaccine or if she was infected again. Her symptoms included headache, nausea, loss of smell, congestion, runny nose, cough and body aches. Patient felt sometime hot sometime she felt chill, she felt cold she felt like that way too. She got a congestion and later be headache and cough then after Friday it's getting worse and worse like she start feeling lot of headache yesterday and then nausea and back pain, the cold and the hot and have a lot of cough. For anatomical site of vaccine, consumer stated, for first dose on the left and second dose on right. The outcomes of events were unknown.

Other Meds:

Current Illness:

ID: 1405799
Sex: F
Age:
State: FL

Vax Date:
Onset Date:
Rec V Date: 06/17/2021
Hospital: Y

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Symptoms: Diagnosed with osteomyelitis post vaccination of both doses; Sour taste in her mouth; This is a spontaneous report from a Pfizer sponsored program from a contactable consumer (patient). A 66-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1st dose, single dose, dose 2 via an unspecified route of administration on 06Feb2021 (Batch/Lot number was not reported) as 2nd dose, single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient has been diagnosed with osteomyelitis post vaccination of both doses of the PFIZER-BIONTECH COVID-19 VACCINE. She got her last dose on 06Feb2021. She also reported a sour taste in her mouth. The patient mentioned that she allegedly read on the Pfizer website the occurrence of transverse myelitis post vaccination of the PFIZER-BIONTECH COVID-19 VACCINE. She wanted to know if osteomyelitis has also been reported. The patient had both doses of the Covid-19 Vaccine and got out of the hospital a week ago. She was in the hospital from osteomyelitis. She saw that there were side effects from the spine for the Covid vaccine and wanted to know how it happened. She was confused. She has been sitting here the past week going how the heck did this happen and what did she do. She was diagnosed with osteomyelitis and was wondering if it could be a side effect. She has an appointment with the neurosurgeon in an hour. She was told she was being transferred to a medical professional who could answer her question. Reporter seriousness for osteomyelitis was hospitalization. The outcome of the events was unknown. Information about lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1405800
Sex: F
Age:
State: FL

Vax Date: 03/26/2021
Onset Date: 03/26/2021
Rec V Date: 06/17/2021
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Symptoms: blood vessels to burst around eyes; severe swelling and itching in entire face, neck, ears, around eyes; severe swelling and itching in entire face, neck, ears, around eyes; growths that popped up in entire neck area; Dose number 1: 08Mar2021, dose number 2: 26Mar2021; This is a spontaneous report from a contactable consumer(patient). A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 26Mar2021 16:00 (Lot Number: EP6955) at her 48-year-old as 2nd dose, single dose for covid-19 immunization. The patient medical history was not reported. She was not pregnant,no known allergies, no other medical history. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were no concomitant medications. Historical vaccine included first dose of BNT162B2 on 08Mar2021 12:00 PM (Lot number: EN6208) in left arm at her 48-year-old for COVID-19 immunization. On 30Mar2021 10:00, the patient experienced severe swelling and itching in entire face, neck, ears, around eyes (causing blood vessels to burst around eyes) and growths that popped up in entire neck area that wasn't there before and still exists to date 01Jun2021. Treatment Steroids received for all events and physician office visit required. Outcome of blood vessels to burst around eyes, severe swelling and itching in entire face, neck, ears, around eyes, and growths that popped up in entire neck area was not recovered. Case was assessed as non-serious.

Other Meds:

Current Illness:

ID: 1405801
Sex: F
Age:
State: CA

Vax Date: 02/12/2021
Onset Date: 03/10/2021
Rec V Date: 06/17/2021
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Symptoms: Blood clot in the right lower leg; This is a spontaneous report from a contactable consumer (patient). This 58-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) second dose at the age of 58-year-old (lot number=EN 6201) on 12Feb2021 at 12:30 PM as single dose on Left arm for COVID-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19. Medical history included Diabetes, CAD, arthritis and known allergies Yes. The patient was not Pregnant at Time of Vaccination. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination. The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) first dose at the age of 58-year-old (lot number=EL1283) on 22Jan2021 at 12:30 PM as single dose on Right arm for COVID-19 immunization. The patient experienced adverse event of Blood clot in the right lower leg on 10Mar2021 at 04:00 PM. The adverse event result in Doctor or other healthcare professional office/clinic visit. The treatment of Blood thinner received for the adverse event. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the event was Unknown. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1405802
Sex: F
Age:
State: OH

Vax Date: 04/16/2021
Onset Date: 04/01/2021
Rec V Date: 06/17/2021
Hospital: Y

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Symptoms: Loss of balance; fell; Dizziness; Hurts; Weaker side on the right, with right hand and right leg; This is a spontaneous report from a contactable consumer (patient's husband). A 26-year-old female patient (young and healthy, Height: 168 cm, Weight: 56.7) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 16Apr2021 (Lot Number: ER8735) as 2ND DOSE, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were none. The patient previously received the first dose of bnt162b2 for covid-19 immunisation on 26Mar2021 (Lot: ER8727, Expiration date: 31Jul2021, Left arm). The consumer mentioned that she experienced dizziness and a loss of balance after the shot, to which she fell on 19Apr2021 and was brought to the ER. It was suspected that she had a TIA or a mini stroke but the results of computerised tomogram head (CT test for brain) and magnetic resonance imaging (MRI) came back show negative. He mentioned that this happened a month and a half ago and she is doing fine as of calling. Fell and couldn't balance has gotten a lot better. Still as weaker side on the right, with right hand and right leg. States she needs a walker sometimes and at the end of the day when she walks a lot, still has some dizziness sometimes and has to go see family doctor every 2 weeks. Caller states supposed to see rehab doctor today, first appointment available. The consumer states he was told by doctors he needed to call Pfizer to check in and see what's going on with that. They would like to know of this has been reported. States they went later, 8 hours after her first fall. Reports first fall and couldn't balance herself occurred on 19Apr2021 at 03:00 in morning and didn't think it was anything serious until 10:00, he came back home and it was still occurring & still falling. Caller states they sent her to emergency room right away and he thinks she fell again in front of doctor and that's why they had to test her a lot. Caller states they kept her a day inside and wouldn't let him in and did every test and wouldn't let her go until the day after. Caller was not really sure if admitted to a hospital room or stayed in the emergency room during visit, but thinks a hospital room. Went to ER around 15:00 on 19Apr2021 and kept until 20Apr2021. States doctor would love to keep her another day and then he doesn't know what happened, but after 3-4 hours that day, nurse came over and said she could then go home. Confirmed this day was 20Apr2021. Been going to acupuncture doctor every week. Sees family doctor every 2 weeks, Re-hab appointments starting today. States family doctor gave her the following medications: Ferrous Sulf 325 mg one tablet every day; and Naproxen 500 mg twice a day. Caller states dizziness has gotten better, happens at the end of the day, and for right sided weakness, she still has harder time to pick up smaller stuff and doesn't work functionally as well as before and if she puts pressure on it, then it hurts. None history of all previous immunization with the Pfizer vaccine considered as suspect. None additional Vaccines Administered on Same Date of the Pfizer Suspect considered as suspect. None prior Vaccinations (within 4 weeks) prior to the first administration date of the suspect vaccine(s). The events Fall and couldn't balance, Weakness of right side require a visit to Emergency Room and Physician Office. The patient was hospitalized for loss of balance, to which she fell from 19Apr2021 to 20Apr2021. The outcome of hurts was unknown. The patient was recovering from other events.

Other Meds:

Current Illness:

ID: 1405804
Sex: F
Age:
State: FL

Vax Date: 05/30/2021
Onset Date: 05/31/2021
Rec V Date: 06/17/2021
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Symptoms: passed out; fall; she felt kind of weird.; bruised and sore; bruised and sore; This is a spontaneous report from a contactable consumer (patient). A 55-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 30May2021 14:00 (Lot Number: EW8736, at vaccination age 55 years old) as 2ND DOSE, SINGLE DOSE for covid-19 immunisation. The patient medical history was none. The patient's concomitant medications were not reported. The patient previously took the first dose of bnt162b2 on 07May2021 13: 00 in left arm (LOT: EW0171) for covid-19 immunisation and had no adverse effect. The patient expected to feel the normal things like tiredness, feeling crappy, but she got her vaccine on Sunday 30May2021 at 14:00 and then the next morning 31May2021 when she woke up at 0730, she didn't know how many hours that is, she got up, she was putting her contacts in and she felt kind of weird. The next thing she knows she was passed out by her bed. Then she got up, put her other contact in, then she had to let her dogs out. She went to let her dogs out and passed out again. It was really bizarre, she never faints ever. Luckily she didn't get injured from the fall, but is bruised and sore. AE(s) did not require a visit to emergency room or physician office. The outcome of event passed out was recovered, others was unknown.

Other Meds:

Current Illness:

ID: 1405805
Sex: F
Age:
State: IA

Vax Date: 05/14/2021
Onset Date: 05/15/2021
Rec V Date: 06/17/2021
Hospital:

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Symptoms: I began getting a rash. It got worse each day and appeared all over my body; itchy; warm; This is a spontaneous report from a contactable consumer (patient). A 38-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EW0168), Left arm on 14May2021 08:00 AM at age of 38-year-old, as single dose, for covid-19 immunisation. Medical history included Celiac disease, rheumatoid arthritis. Prior to vaccination, the patient did not diagnose with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No any other medications the patient received within 2 weeks of vaccination. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Left arm on 23Apr2021 08:15 AM at age of 38-year-old at single dose lot: ER8737 for covid-19 immunisation. Within 40 hours of receiving second dose on 15May2021 23:00, she began getting a rash. It got worse each day and appeared all over body. The rash spread so bad that on day 14 ,she went to a care. She was prescribed steroids over a 9 day period. She was on day 4 currently. Still have rash. It's itchy, warm, and hurts. It's on arms, legs, back, chest, stomach, neck, and face. Adverse events result in Emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Outcome of the events was not recovered.

Other Meds:

Current Illness:

ID: 1405806
Sex: M
Age:
State: FL

Vax Date: 03/24/2021
Onset Date:
Rec V Date: 06/17/2021
Hospital:

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Symptoms: pneumonia; severe bronchitis; pain at the injection side upper torso, both arms , shoulder, chest on the right side and tinnitus; pain at the injection side upper torso, both arms , shoulder, chest on the right side and tinnitus; pain at the injection side upper torso, both arms , shoulder, chest on the right side and tinnitus; pain at the injection side upper torso, both arms , shoulder, chest on the right side and tinnitus; pain at the injection side upper torso, both arms , shoulder, chest on the right side and tinnitus; tinnitus; had tinnitus which is interfering with sleep and cognition; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient) reported for himself that the 64-year-old male patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 24Mar2021 (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunisation. Medical history included bronchitis chronic from 1963, diabetes mellitus from an unknown date and unknown if ongoing, arthritis from an unknown date and unknown if ongoing, bronchitis from an unknown date and unknown if ongoing, pneumonia from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient experienced pneumonia on an unspecified date with outcome of unknown, severe bronchitis on an unspecified date with outcome of unknown, pain at the injection side upper torso, both arms, shoulder, chest on the right side and tinnitus on an unspecified date with outcome of unknown, had tinnitus which is interfering with sleep and cognition on an unspecified date with outcome of unknown. The clinical course was reported as follows: The patient received his first dose of the Pfizer covid vaccine on Mar24 and since 10 weeks he has pain at the injection side, upper torso, both arms , shoulder, chest on the right side and tinnitus. The patient wanted to know about prolonged pain. He stated " study and study states 0.8 percent of receiptant of the covid vaccine (unknown manufacture) suffered tinnitus. He said she had severe bronchitis, pneumonia 8-10 times. He was confined to bed for 6 weeks when last time he had pneumonia. The patient is still experiencing pain all throughout the area of the injection site, upper torso, both arms and he has had tinnitus which is interfering with sleep and cognition. The patient clarified that the date of his 1st dose was on 24Mar2021 which will be 10 weeks ago tomorrow and what he has experienced is not something he had expected. He does have severe underlying conditions that he has to be protected from COVID for. He has had chronic acute bronchitis since 1963 and when he was into his 30s the bronchitis advanced to walking pneumonia at least 8 times and severe pneumonia twice. He has never had a common cold, every time he has had a common cold it has progressed into his lungs to bronchitis and ever since his mid 30s he has developed some form of minor to acute pneumonia. He didn't go looking for symptoms on the internet he developed these problems and then he searched and there's an study, a study and a study that all say that tinnitus affects about 0.8% of the population and he has had it for 10 weeks. It has never stopped. It is affecting his sleep, his cognitive ability and his concentration. As for his shoulder, he doesn't know about that as much. He hasn't found any studies on the internet for long term severe pain but it may be an aggravation of a former injury. He would like to see if this severe long term pain has been reported before. He asks, would you advise to get a second dose? Apparently he has read more of the studies online than the doctors he has consulted in his county have. The only response he got from the doctors there were that they don't think the COVID vaccine caused his condition. No one has read any studies of any adverse reactions or at least none that are in his HMO which is his Medicare advantage program, so he is limited in his choice of doctors. He has diabetes, arthritis, and he can't even remember his other preexisting conditions, that's how bad the tinnitus is affecting him. Information on Lot/Batch number has been requested.

Other Meds:

Current Illness:

ID: 1405807
Sex: F
Age:
State: AZ

Vax Date: 02/26/2021
Onset Date: 02/01/2021
Rec V Date: 06/17/2021
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Symptoms: sinus headaches; Her platelets are supposed to be 150,000 to 180,000, and hers are normally 120,000. Right now they are like 30,000.; Suspect ITP; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received bnt162b2 (BNT162B2), dose 2 administered in Arm Left on 26Feb2021 (Batch/Lot Number: EL9267) at age of 67-year-old as 2ND DOSE, SINGLE for covid-19 immunisation. Time the Vaccination Was Given Between 1100 and 1300. Vaccination Facility Type was Mass vaccination drive thru site. Medical history included she had a low platelet count before the vaccine, Seasonal allergies, Sinus headaches, diagnosed allergies, compromised immune status, respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity. She doesn't remember what vaccines caused her to have a sore arm, maybe tetanus, but she doesn't remember. Her maternal grandmother had leukemia which is one of the possible causes. She never had anybody else in her family with ITP or anything like that. Concomitant medications included paracetamol (TYLENOL), ibuprofen, caffeine, paracetamol (EXCEDRIN), all taken for headache. She had both doses of the Pfizer covid 19 vaccine. The patient had her first dose of the Covid-19 Vaccine (lot: EL9269) on 05Feb2021 in her right arm and her second dose in her left arm on 26Feb2021. One of the reasons she got them in 2 different arms was because she heard she might be less likely to have arm pain. She doesn't remember what vaccines caused her to have a sore arm, maybe tetanus, but she doesn't remember. It has been years since she had another vaccine. She had enough that she actually wrote in her journal on 28Feb2021 that she was getting unusual black and blue marks all over and they were bigger than usual. It is possible it was immediately as soon as she had the second dose. She wrote on 28Feb2021, but she knows that is not the first day she noticed it. It is getting better. she still gets new ones that seem random. She has 2 marks right now on her trunk. She has one on her stomach and one on her side. She is still getting them but not as frequent or as bad. Some she knew where they were from, and others she had no recollection of hitting herself. She went to the doctor and had a regular physical and bloodwork done, and she is in the process of being diagnosed. They suspect ITP (Immune Thrombocytopenia Purpura). The AE require a visit to Physician Office. She gets seasonal allergies, and from time to time she gets sinus headaches. She thinks she might have had some headaches at that time. She assumed they were sinus headaches because it felt like they were. During the day she took 1 Excedrin and 1 Extra Strength Tylenol for the headaches. At night she sometimes took 2 Tylenol and sometimes Ibuprofen. She does remember having some headaches. Her headaches come and go. She had them she is thinking in February or March. She still has headaches. It is normal for her year round. She had quite a few more for a while, but now it is more normal like once a week. She takes the Excedrin, Extra Strength Tylenol, and Ibuprofen as needed. She tends to go with Excedrin and Tylenol for headaches during the day if she can. At night she tends to go with Tylenol unless she took it too close to bedtime to be able to take it at night. The Tylenol is 500mg. The Excedrin is a mixture of 250mg Acetaminophen, 250mg Aspirin, and 65mg caffeine. When she took the Ibuprofen she usually took 600mg. She did have bloodwork done. Her platelets are supposed to be 150,000 to 180,000, and hers are normally 120,000. Right now they are like 30,000. They said if she notices anything weird to go to the ER. She has had several platelet tests done. The first was on 04May2021, and her platelets were 30,000. The second was on 11May2021, and her platelets were 30,000. She had it done again on 17May2021, and her platelets were 25,000. Last week she had a bone marrow scan, and she will need a bone marrow biopsy. She did have a bone marrow biopsy done at a surgery center, but no treatment. It was to rule out other possible causes. The outcome of sinus headaches was recovering, of other events was unknown.

Other Meds: TYLENOL; IBUPROFEN; EXCEDRIN [CAFFEINE;PARACETAMOL]

Current Illness:

ID: 1405808
Sex: M
Age:
State: CT

Vax Date: 05/11/2021
Onset Date: 05/14/2021
Rec V Date: 06/17/2021
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Symptoms: There where times where I felt I was going to pass out; I became very dizzy and fatigued/ light headedness; I became very dizzy and fatigued; Had extreme brain fog and light headedness; Had shortness of breath. Tightness in throat and dry mouth; Tightness in throat and dry mouth; Tightness in throat and dry mouth; I also developed a very strong metal taste in my mouth that lasted for a few weeks; Sometimes I would also get strange sensations or weakness in my muscles with sweats or hot flashes; Sometimes I would also get strange sensations or weakness in my muscles with sweats or hot flashes; Sometimes I would also get strange sensations or weakness in my muscles with sweats or hot flashes; Some days I would wake up feeling like I was intoxicated like a drunk feeling; The feelings also came with extreme anexity and panic although the symptoms themselves could have caused that; The feelings also came with extreme anexity and panic although the symptoms themselves could have caused that; Sometimes I would also get strange sensations or weakness in my muscles with sweats or hot flashes; This is a spontaneous report from a contactable consumer (patient). A 33-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 11May2021 10:15 (at 33-year-old) (Lot Number: EW0182) as 2nd dose, single in arm right for COVID-19 immunisation. Medical history included anxiety, depression, and panic. No known allergies. The patient's concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 19Apr2021 15:30 (at 33-year-old) (Lot Number: EW0171) as 1st dose, single in arm right for COVID-19 immunisation. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient wasn't diagnosed with COVID-19. After about 7-10 days after 2nd dose vaccination he became very dizzy and fatigued, and had extreme brain fog and light headedness. There where times where he felt he was going to pass out. He also had shortness of breath, tightness in throat and dry mouth. He also developed a very strong metal taste in his mouth that lasted for a few weeks. Sometimes he would also get strange sensations or weakness in his muscles with sweats or hot flashes. Some days he would wake up feeling like he was intoxicated like a drunk feeling. The feelings also came with extreme anexity and panic although the symptoms themselves could have caused that. The onset date of events was reported as 14May2021 02:30 am. No treatment received for events. Since the vaccination, the patient hasn't been tested for COVID-19. The outcome of the events was resolving.

Other Meds:

Current Illness:

ID: 1405809
Sex: F
Age:
State: FL

Vax Date: 05/28/2021
Onset Date: 05/28/2021
Rec V Date: 06/17/2021
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Symptoms: felt exhausted; Blood pressure low, after the seizure: 73/49 and 68/42; skin pale and sweating, after the first vaccine; skin pale and sweating, after the first vaccine; Tired and weak, with some lightheadedness, after the first vaccine; Tired and weak, with some lightheadedness, after the first vaccine; Seizure: described as staring, passing out, stiffening of arms, talking like a toddler and giddy, after the first vaccine.; Seizure: described as staring, passing out, stiffening of arms, talking like a toddler and giddy, after the first vaccine.; Seizure: described as staring, passing out, stiffening of arms, talking like a toddler and giddy, after the first vaccine.; Seizure: described as staring, passing out, stiffening of arms, talking like a toddler and giddy, after the first vaccine.; Seizure: described as staring, passing out, stiffening of arms, talking like a toddler and giddy, after the first vaccine.; felt funny; This is a spontaneous report from a contactable consumer(mother, a nursing assistant, years ago) reported for a patient(daughter). The 16-year-old female patient received bnt162b2 (BNT162B2, Pfizer vaccination, Covid vaccine) at the age of 16-year-old, dose 1 via an unspecified route of administration, administered in Arm Left on 28May2021 11:52 (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunisation. Medical history included seizure from 28May2021 to an unknown date (doctor wants to schedule an EEG, for further evaluation of the seizure ,because they did not do that test in the hospital.), ongoing Feels down at times (Consumer states the doctor originally prescribed her daughter another medication. Because all the appointments were by video, Consumer felt the doctor was not understanding her daughter's issue. Consumer states the original medication for ADHD was helping her daughter, but it made her daughter uncomfortable, as her daughter had no problems with attention, or school. Caller states then the doctor changed the medication to Zoloft. Name of previous medication was Zenzedi.). No family Medical History. Concomitant medication included sertraline hydrochloride (ZOLOFT) taken for depressed mood from 19May2021 and ongoing. Consumer states that her daughter is not depressed, but just feels down at times, and it is not severe. Consumer states the doctor had her daughter on another medication before Zoloft, that is used for ADHD. Consumer states that her daughter has not been diagnosed with ADHD, and the doctor switched the medication once her issues were further understood, as clarified in later part of report. The patient experienced seizure: described as staring, passing out, stiffening of arms, talking like a toddler and giddy, after the first vaccine on 28May2021 with outcome of recovered, felt funny on 28May2021 with outcome of recovered , blood pressure low, after the seizure: 73/49 and 68/42 on 28May2021 11:52 with outcome of recovered , skin pale and sweating, after the first vaccine on 28May2021 with outcome of recovered , skin pale and sweating, after the first vaccine on 28May2021 with outcome of recovered, tired and weak, with some lightheadedness, after the first vaccine on 28May2021 with outcome of unknown, tired and weak, with some lightheadedness, after the first vaccine on 28May2021 with outcome of unknown, felt exhausted on an unspecified date with outcome of unknown. The patient underwent lab tests and procedures which included blood pressure measurement: 73/49 on 28May2021 low , blood pressure measurement: 68/42 on 28May2021 low , blood pressure measurement: normal on 28May2021, heart rate: 55 on 28May2021, heart rate: 70 on 28May2021. The clinical course was reported as follows: Consumer states she took her daughter Friday, to have her first Pfizer vaccination, later reclarified as the Covid vaccine. Consumer states her daughter had a seizure after the vaccine. Consumer states Height maybe 5'8" or 5'9". Consumer states her daughter was weighed at the hospital. Consumer states that the experience was terrifying for her, to watch her daughter have the seizure. Consumer states her husband got the vaccine, and was fine. Consumer reports that her daughter got the vaccine at 11:52 am and within 30 seconds, her daughter said she felt funny, and then rolled her eyes and passed out. Consumer states after a minute, her daughter was conscious and the staff was rushing to her aid, as the Consumer called 911. Consumer states that for the next 25 to 30 minutes, her daughter was talking like a toddler, and was pale and sweating. Consumer states that the paramedics, told her daughter that she had a seizure, as they took her to the hospital. Consumer reports her daughters blood pressure, around the time of the event. Consumer states the first blood pressure, when her daughter awakened, after the seizure about 2 minutes later was 73/49, pulse 55, and a few minutes after that it was 68/42 and her pulse was 70. Seizure: Time: 11:52 am, almost immediately after the vaccine. Outcome: caller answers as she is monitoring her daughter closely. Consumer states that during her seizure, her daughter started to stare, and then passed out. Consumer states her daughter did have some stiffening of the arms with the seizure. Blood pressure low: Consumer states he daughter's blood pressure, began to elevate, before they transported her to the emergency room. Time: 11:52 am, almost immediately after the vaccine. Outcome: Consumer answers as her daughter's blood pressure was stabilized enough by the time she was transferred to the hospital, where it normalized. Consumer reports later that her daughter's skin was pale and she was sweating, at this time. Reclarified, Consumer states that when her daughter was talking to the medical staff, she was talking like a toddler, and giddy. Consumer states she was trying to tell the staff that this is not normal for her daughter. Consumer reports her daughter feels tired and weak after all the events. Consumer states she signed up for VSafe. Time: Consumer states sometime, after the vaccine. End: Consumer answers as her daughter is not as tired and weak, as she was the first day the event happened. Caller states that the next day, her daughter relaxed all day, and the day after that, her daughter went to work and felt exhausted, but felt that she could still go to work. Consumer states that yesterday at work, her daughter said she felt weak, and lightheaded. Consumer states that after having a snack and a break, her daughter felt better and worked the rest of her shift. Outcome: Unknown. Reclarified, Caller states she does not want to assume anything, and is monitoring her daughter, and that this event may be due to another reason, as well. Consumer clarifies her daughter went to the emergency room and then was released. Vaccination Facility Type was pharmacy. No Vaccine Administered at Military Facility. No History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available).No additional Vaccines Administered on Same Date of the Pfizer Suspect. The event Seizure required a visit to Emergency Room, not Physician Office. Prior Vaccinations (within 4 weeks), list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine was none. No AE(s) following prior vaccinations. Caller reports some prior vaccinations that her daughter had without any events. Consumer states that her daughter is not going to get the second vaccination. Consumer states that she does not know the potential risk, if her daughter gets another vaccination. Information about lot/batch number has been requested.

Other Meds: ZOLOFT

Current Illness: Depressed mood (Caller felt the doctor was not understanding her daughter's issue.)

ID: 1405810
Sex: F
Age:
State:

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Rec V Date: 06/17/2021
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Symptoms: We tested positive after receiving the first vaccination; This is a spontaneous report from a contactable male consumer reported for himself and his wife, this is second of 2 cases, for the female patient (wife). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1st dose, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Reporter stated, "On 07May of this year I took the covid-19 vaccination. Two days later I was very sick. When was tested and come to find out I had the virus, the Covid- 19 virus. Okay we together, my wife and I have done the 14 day quarantine which ended this past Saturday on 29th. So my question is should we take the second vaccination, since how we tested positive after receiving the first vaccination." The patient underwent lab tests and procedures which included sars-cov-2 test: positive. Outcome was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021635316 same reporter/product, different patient / event.

Other Meds:

Current Illness:

ID: 1405811
Sex: F
Age:
State:

Vax Date: 05/20/2021
Onset Date: 05/27/2021
Rec V Date: 06/17/2021
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Symptoms: blood clot; high levels of d dimer in blood; very dizzy; can barely walk; migraine; fatigue; chills; temperature changes; pain in body switching from left to right and vice verse; chest pain; shallow breathing; This is a spontaneous report from a non-contactable consumer. This consumer (patient) reported that a 29-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 29-years, via an unspecified route of administration on 20May2021 at single dose for COVID-19 immunization, in hospital. Medical history was not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at time of vaccination. Concomitant medications included gabapentin, lorazepam (ATIVAN), norethisterone (NORETHINDRONE), omeprazole. The patient previously received all antibiotics except for doxycycline. The patient went to hospital to check for blood clot; high levels of d dimer in blood; very dizzy, can barely walk; migraine; fatigue; chills and temperature changes; pain in body switching from left to right and vice verse; chest pain and shallow breathing; serious side effects 1 week later. The events occurred on 27May2021. The adverse events resulted in doctor or other healthcare professional office/clinic visit, resulted in emergency room/department or urgent care. Outcome of the events was not recovered/not resolved. Since the vaccination, the patient has not been tested for COVID-19. No follow-up attempts are possible; information about lot/batch number cannot be obtained

Other Meds: GABAPENTIN; ATIVAN; NORETHINDRONE [NORETHISTERONE]; OMEPRAZOLE

Current Illness:

ID: 1405812
Sex: F
Age:
State: MA

Vax Date: 04/15/2021
Onset Date: 04/23/2021
Rec V Date: 06/17/2021
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Symptoms: ITP (immune-mediated thrombocytopenia); This is a spontaneous report from a contactable other HCP (patient). A 49-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in left arm on 15Apr2021 13:15 (Batch/Lot Number: ER8729) as 1st dose, single for covid-19 immunisation; paracetamol (TYLENOL), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication. Medical history included premature menopause. Patient not diagnosed with COVID-19 Prior to vaccination. The patient previously took penicilline and sulfa drugs and experienced allergy. Concomitant medications within 2 weeks of vaccination include Multivitamin and paracetamol (TYLENOL). No other vaccines within 4 weeks prior to the COVID. The patient experienced ITP (immune-mediated thrombocytopenia) on 23Apr2021. Patient received immunosuppression with steroids for the event. The outcome of event was not recovered. Patient received dose 2 administered in left arm on 06May2021 13:15 (Batch/Lot Number: EW0175). Patient has not been tested for COVID-19 Since the vaccination.; Sender's Comments: Based on the current limited available information and the drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event of Immune-mediated thrombocytopenia cannot be totally excluded/assessed. The case will be reassessed if additional information becomes available.

Other Meds: TYLENOL

Current Illness:

ID: 1405813
Sex: M
Age:
State: AL

Vax Date: 05/21/2021
Onset Date: 05/01/2021
Rec V Date: 06/17/2021
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Symptoms: hot and cold with sweats; hot and cold with sweats; Shortness of breath; Eyes ache and itch a little bit; Headache, like stuffed up, sinus headache; Rattling in chest at night like fluid/ whistling sounds; whistling sounds; A lot of mucus in lungs; got real sick with flu-like symptoms; got real sick with flu-like symptoms; coughing up a lot of; heat flash; feeezing; cold, flu, and pneumonia feel like; chills; joint pain; Severe pain in left bicep; pulled muscle; muscle was tight; Eyes ache and itch a little bit; he was 215 and now 223 lbs. Seems like he gained weight; This is a spontaneous report from a contactable consumer (patint). A 64-year-old male patient received the second dose of BNT162B2 (PFIZER COVID-19 VACCINE), via an unspecified route of administration, administered in right arm on 21May2021 13:00 (Lot Number: EW0168) at the age of 64 years as 2nd dose, single dose for COVID-19 immunisation. Medical history included arthritis and pneumonia, had not been diagnosed with COPD, but took a lung test, and was prescribed this symbicort 3 months ago. During the pandemic he was never sick and never had symptoms of COVID, was never hospitalized or none of that. Patient was tested and was negative. Concomitant medication(s) included budesonide, formoterol fumarate (SYMBICORT). Historical vaccine included the first dose of BNT162B2 via an unspecified route of administration, administered in left arm on 30Apr2021 (Lot Number: EW0171) at the age of 64 years as single dose for COVID-19 immunisation. Within seven days of taking second shot, patient began to get real sick with flu-like symptoms, started 5 days after he took second shot. Was feeling fine, usually did an hour walk every morning. And 5 days ago, did an extra 30 minutes on his walk to boost himself and that's when he began to get sick. Confirmed date as 26May2021. Still came and went. Stated he developed mucus in his lungs began 27May2021, on 28May2021, got more mucus in his lungs. This past Saturday, didn't buy Mucinex, but got something for severe cold and chest to break up mucus from forming. Patient stated today he was able to start back walking and gradually coughing up mucus. Improving slowly, but surely. Denied shortness of breath. Has rattling in chest at night like fluid, which began on 27May2021. Hot and cold with sweats began on 29May2021 and were not as bad as they were. Stated women should have not men. Shortness of breath began on 28May2021. Not to the point of having to call emergency services. Stated it all came down on him at once. Stated he started to call for ambulance but didn't most emergency rooms sit there for 11 to 12 hours before looking at you or fall out dead. Reported slowly getting better. No sneezing, just felt like he was feverish, but did not have a fever, didn't have a thermometer so he could only go by sweat that he had and the chill he has. Patient stated joint pain that normally didn't bother him. Stated the first shot didn't affect him the way the second shot had. States he now had a little joint pain, like pulled muscles around his lungs, around biceps, sharp pains around biceps. Severe pain in left bicep on 27May2021. His friend thought he was having a heart attack, but wasn't. It was up above heart more like a pulled muscle than a heart attack pain. Patient stated this morning while outside after his walk, all of a sudden a pulled muscle pain in bicep on right side. Stated was this thing moving around on me since started on left side now on right side. Pain had stopped was just a sharp pain, muscle was tight. Stated has never had sharp pains to hit him like that since he was alive. Patient stated he did not have a runny nose, his eyes may ache and itch a little bit, but was coughing up a lot of, had whistling sounds and had a lot of mucus in his lungs. Patient had rattling in chest at night like fluid on 27May2021. Hadn't had runny eyes or stuff in the corner of his eyes. Patient felt like he has gained weight since taking the shot. He was 215 and now 223 lbs. Seems like he gained weight. Patient had headache, like stuffed up, sinus headache from 27May2021. Patient was taking generic brand Tylenol for joint pain. When having chills, he would take 2 in the morning and drink hot coffee. Then all of sudden, went along with joint pain and chills, after moving around and walk outside, broke out into a heat flash. Stated this was irritating. He's freezing one minute and about to burn up the next. Vicks Dayquil pill form for severe cold and allergy to help mucus in chest. Stated he was not able to make it that far to a drug store or Walmart and got from service station. Stated he had had a cold and knew what cold, flu, and pneumonia feel like, what he used to have before this Covid thing. Stated he knew how to recognize some things and not put himself to point of not getting any help. The Symbicort Budesonide didn't do anything to release the mucus. It seemed like it just bypassed that. AEs did not require a visit to emergency room or physician office. Outcome of events got real sick with flu-like symptoms, a lot of mucus in lungs, headache, like stuffed up, sinus headache, hot and cold with sweats, shortness of breath, eyes ache and itch a little bit was recovering, joint pain, muscle pain, pulled muscle, muscle was tight, was recovered and the other events was unknown.

Other Meds: SYMBICORT

Current Illness:

ID: 1405814
Sex: F
Age:
State: SC

Vax Date: 04/07/2021
Onset Date: 05/01/2021
Rec V Date: 06/17/2021
Hospital: Y

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Symptoms: hospital with AFib; Has clots in both legs/Developed one blood clot in arm; fell; Has clots in heart, in multiple areas of heart; This is a spontaneous report from a contactable consumer (patient's daughter). A 75-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 07Apr2021 (Batch/Lot Number: ER8733) as 2nd dose, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration in arm on 10Mar2021 (Lot Number: EN6204) for covid-19 immunisation. The patient in hospital with AFib on 21May2021. The patient fell on 17May2021, it was unsure if the patient fell on 17May2021 from the AFib. The patient had been hospitalized since 21May2021. It was unknow if the reason the patient fell was because the patient went into a different rhythm. The patient got sick and got AFib. The AFib was still ongoing and the patient was still hospitalized. The patient had clots in both legs, it began when the patient was hospitalized on 21May2021. The patient had no history of blood clots. The patient had clots in heart, in multiple areas of heart. All the blood clots were acquired while the patient was in the hospital. The patient developed one blood clot in arm on 31May2021 after being on apixaban (ELIQUIS), the patient acquired a clot in one arm. The other clots started on 28May2021 and 29May2021. In past weekend the patient went in to get a TEE and they could not perform the TEE because the callers mother had blood clots in her heart. Reporter seriousness for events hospital with AFib and clots in both legs/clots in heart, in multiple areas of heart/developed one blood clot in arm was unspecified. The outcome of events was unknown. No follow up attempts are possible. No further information is expected.

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Current Illness:

ID: 1405816
Sex: F
Age:
State: CA

Vax Date: 02/20/2021
Onset Date: 03/15/2021
Rec V Date: 06/17/2021
Hospital: Y

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Symptoms: The patient experienced occurrence of E.coli sepsis on 15Mar2021 and ended up in hospital; The patient experienced occurrence of E.coli sepsis on 15Mar2021 and ended up in hospital; The patient got so weak; This is a spontaneous report received from a contactable retired registered nurse (patient). An 85-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in arm left (left shoulder, but not certain) on 20Feb2021 11:30 (Batch/Lot Number: EN6701) at age of 85-year-old at single dose for COVID-19 immunization (the patient didn't want to catch COVID and wanted to have antibodies to fight it). Vaccine was not administered at known Facility. Medical history included first hospitalization for E.coli (Escherichia coli) sepsis was in Feb2021, prior to receiving the first dose Pfizer COVID Vaccine, the patient received more antibiotics from home health and the patient was in the hospital for five days from 01Feb2021 to 05Feb2021 and had the last antibiotic on 09Feb2021. Concomitant medications included ceftriaxone (ROCEPHIN) and cefalexin (KEFLEX) taken for E.coli sepsis from 15Mar2021 to 02Apr2021. Prior Vaccinations (within 4 weeks) there was not any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. The patient experienced occurrence of E.coli sepsis on 15Mar2021 and ended up in hospital. The patient had been in the hospital again after receiving the first dose Pfizer COVID Vaccine for the patient's second occurrence of E. Coli sepsis. The patient was in rehab by 01Apr2021 and was taken by medical transport at the hospital to receive her second dose Pfizer COVID Vaccine. The patient clarified she had E.coli sepsis twice. The patient's first hospitalization for E.coli sepsis was from 01Feb2021 to 05Feb2021, prior to receiving the first dose Pfizer COVID Vaccine. The caller's second hospitalization was from 15Mar2021 to 02Apr2021, the patient was in rehab for three weeks. The patient stated she was no longer on any antibiotics. The patient was on ceftriaxone first and then cefalexin, IV. The caller was in the emergency room on 15Mar2021 and they admitted the patient at health facility for three days, then they transported the patient to a bed in the rehab area because the patient needed another 21 doses of antibiotics and the patient needed to learn to walk again. The patient got so weak. The patient was discharged on 02Apr2021. The event E.coli sepsis required visit to emergency room and physician office. Relevant tests were none. The outcome of the events was unknown.; Sender's Comments: Based on the limited information in the case, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported E.Coli Sepsis. 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: ROCEPHIN [CEFTRIAXONE]; KEFLEX [CEFALEXIN]

Current Illness:

ID: 1405817
Sex: F
Age:
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Vax Date: 05/01/2021
Onset Date: 05/01/2021
Rec V Date: 06/17/2021
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Symptoms: fell on the floor and she lose all the conscious; she got a kind of choke; fell on the floor and she lose all the conscious; lose all the energy; cannot breathe; This is a spontaneous report from a contactable consumer (patient's mother). A 19-year-old female patient received bnt162b2 (Pfizer product, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on May2021 as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Last Friday (unspecified May2021) she was vaccinated with the Pfizer and she got a lot of symptoms of the vaccine, after 20 seconds she fell on the floor and she lose all the conscious and took that it was minute and half to come up and she got a kind of choke, cannot breathe and lose all the energy, it took almost 2 days to become normal again. The patient's mother did not want her to get another shot. The outcome of events was recovered. Information about lot/batch number has been requested.

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Current Illness:

ID: 1405818
Sex: F
Age:
State: NJ

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Rec V Date: 06/17/2021
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Symptoms: INR was only 1.5 it was below therapeutic range; Dizzy/light headed; she is very upset; Nausea; This is a spontaneous report from a contactable consumer (patient) from a Pfizer sponsored program. A female patient of unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included diabetes type 1. Concomitant medication included escitalopram oxalate (LEXAPRO) taken for an unspecified indication, start and stop date were not reported. The patient experienced INR was only 1.5 it was below therapeutic range, dizzy/light headed, nausea, she was very upset on an unspecified date. Event details: The consumer reported that she received the first dose of the vaccine. Two days after the shot her INR have dropped below therapeutic range she did have the blood disorder (Further not clarified hence not captured in tab) and she was upset that all three of her doctor's told her to get the shot and she have blood disorder so she was very upset about that and like to speak to somebody. She felt like little bit light headed, she felt dizzy and a little bit nausea after the first dose. The outcome of the events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds: LEXAPRO

Current Illness:

ID: 1405819
Sex: M
Age:
State: NJ

Vax Date: 04/19/2021
Onset Date: 04/01/2021
Rec V Date: 06/17/2021
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Symptoms: pain in left arm lasting for about 24 hours; This is a spontaneous report from a contactable consumer (patient). A 45-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in left arm on 19Apr2021 18:30 (Lot Number: EW0161), at the age of 45-year-old, as single dose for COVID-19 immunisation. The medical history included multiple chemical sensitivities and polyneuropathy. The concomitant medication was not reported. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. After Vaccine #1 the patient experienced pain in his left arm lasting for about 24 hours in Apr2021. The outcome of the event was recovered in Apr2021.

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Current Illness:

ID: 1405820
Sex: M
Age:
State: NJ

Vax Date: 05/10/2021
Onset Date: 05/10/2021
Rec V Date: 06/17/2021
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Symptoms: pain in my left arm lasting for about 24 hours; After Vaccine #2 also experienced flu/cold-like symptoms; Body aches/pain; sneezing; running/stuffy nose; running/stuffy nose; This is a spontaneous report from a contactable consumer (patient). A 45-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration, administered in arm left on 10May2021 11:30 (Lot Number: EW0173) at age of 45-year-old at single dose for COVID-19 immunization at facility of Health Clinic. Medical history included multiple Chemical Sensitivities, polyneuropathy. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine or any other medications the patient received within 2 weeks of vaccination. The patient previously took first dose of bnt162b2 (Lot number: EW0161) on 19Apr2021 18:30 in left arm and experienced pain in left arm and lasting for about 24 hours. After second dose, the patient experienced pain in his left arm, flu/cold-like symptoms , body aches/pain, sneezing, running/stuffy nose, all on 10May2021 23:00. The events were serious for disability. There was no treatment for the events. Body aches slowly started to disappear on 11May2021. Other symptoms lessened over the course of next 10 days but never really gone away. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the body aches/pain was resolved on 11May2021, the rest events was resolving.

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Current Illness:

ID: 1405821
Sex: F
Age:
State: TX

Vax Date: 06/02/2021
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Rec V Date: 06/17/2021
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Symptoms: I have been seeing like, like when I see a cord it seems like it moves like a snake; I was laying down and I was looking at my rug, my rug looked like it was moving like a snake; little achy right; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0191) via unspecified route in left arm single dose for COVID-19 immunization on 02Jun2021 09:50 at 53-year-old. Medical history included: blood pressure high. Concomitant medication included lisinopril for blood pressure high. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0176) via unspecified route in left arm single dose for COVID-19 immunization on 11May2021 10:00 at 53-year-old. The patient felt just a little, like little achy right if I have a little small virus but then she took the Ibuprofen (treatment) and was okay but she had been seeing like, like when she saw a cord, like one way you plugged in, it seemed like it moved like a snake and then she was looking, she was laying down and was looking at her rug, her rug looked like it was moving like a snake, like a wave and then she came to see therapist because she had an appointment and when she was driving, it seemed like the road would move like snake also and then the birds were flying, it seemed like, when you see a jet when it flied and it had like a smoke coming from the back, it seemed like the birds had smoke coming from their back and then when shewent to tell her therapist, she thought maybe it's the medicine that was making her, she meant the vaccine was making her that way and she was like talking to her and she had like curtains behind her and it seemed like the curtains are moving around like snake. The patient never had anything like that, ever happened to her. Outcome of the events was unknown. No follow-up attempts are needed. No further information is expected.

Other Meds: LISINOPRIL

Current Illness:

ID: 1405822
Sex: M
Age:
State: NY

Vax Date: 05/18/2021
Onset Date: 05/01/2021
Rec V Date: 06/17/2021
Hospital: Y

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Symptoms: Coronary artery disease; mild tenderness of the injection site of right deltoid; This is a spontaneous report from a Pfizer sponsored program from a contactable consumer (patient). A 62-year-old male patient received bnt162b2 (reported as Pfizer Covid-19 Vaccine), dose 1 intramuscular, administered in deltoid right on 18May2021 14:00 (Batch/Lot Number: EW0172) as 1st dose, single at the age of 62-year-old for covid-19 immunisation. Medical history included essential thrombocythaemia from May2014 and ongoing (Outpatient at withheld since 2015 for this condition. This is a myeloproliferative disorder where bone marrow makes too many blood platelets. Previously on chemotherapeutic agent hydroxyurea from time of diagnosis May2014 until 29Jun2020. Has not been on any other medication since then except low dose aspirin), chest pain, headache, and nausea from 2021 (all started approximately 4-6 weeks prior to 20May2021). The patient's concomitant medications were not reported. The patient previously took acetylsalicylic acid (ASPIRIN) (reported as Low Dose Aspirin) at 81 mg from May2014 and ongoing for essential thrombocythaemia, hydroxycarbamide (HYDROXYUREA) for essential thrombocythaemia from May2014 to 29Jun2020 (Previously on chemotherapeutic agent hydroxyurea from time of diagnosis May2014 until 29Jun2020). Patient received the first dose of bnt162b2 18May2021. From 20May2021 to 25May2021 he got hospitalized and took a blood thinner for 5 days. He is scheduled to receive the second dose of bnt162b2 on 08Jun2021. He wants to know if he can still get the second dose of bnt162b2 if he took the blood thinner for 5 days when he got hospitalized. Patient clarified that he was administered his first dose of bnt162b2 on 18May2021. He reported having chest pains, headaches and nausea that all started approximately 4-6 weeks prior to 20May2021 which was the date he was admitted to the hospital relative to those events. He specified that these events were ongoing prior to him ever being administered the bnt162b2. He was admitted to the hospital on 20May2021 until discharged on 25May2021. He has had no further episodes of these events, but whether recovered completely or with lasting effects is unknown. Patient is a retired medical laboratory technician, has a degree, has worked in medical labs in the past but is currently retired. Admitted to hospital as cardiac patient with no cardiac history prior to initial onset of these events around 4-6 weeks prior to 20May2021. He was brought to the hospital emergency department via ambulance that he himself called. While hospitalized they recommended surgery to him, he declined surgery, left the hospital and is seeking another opinion. While hospitalized he was administered blood thinner or anti-coagulant Heparin intravenously. He was not sure if he started Heparin on 20May2021 or 21May2021, but thinks it was from 21May2021 to 25May2021. He thinks he was brought to the hospital and admitted somewhere between 22:30 on 20May2021 and 00:00 21May2021; but verified hospitalization repeatedly as starting 20May2021. Patient provided additional details regarding these events: about 4-6 weeks prior to 20May2021 he had been having rather severe headaches, nausea and chest pain-not constantly, but having them. He had been able to function, in other words take care of himself, do business although sometimes a bit difficult and uncomfortable because of those symptoms but got it done. On 20May2021 when this continued he had been pretty busy that day out from about 10:00 or 11:00 until about 21:30. He accomplished everything he wanted to do that day, had eaten a couple of times. He had no headaches that day, had some chest pains, nausea but at end of day when he came home about 21:30 he had the worst chest pain of the day. Because he had been having these types of symptoms: headaches, nausea, chest pain for 4-6 weeks before that, he called ambulance went to local hospital called his primary doctors' office before he did that; and so they agreed he should go so he did. The tests that were performed were amongst many blood tests from CBCs to chemistry to PTT to a PTT because he had been put on heparin particularly. Maybe a lipid profile type test, was given an echocardiogram and an angiogram. Put on a cardiac unit; no prior cardiac history or heart problems prior to this. Regarding results they were saying he had coronary artery disease; that had 3 modes of treatment: anything from medication regimen only to stent to bypass or open heart surgery so that's the sort of testing that was done. He never looked, he's going to get records in the future. He has been a medical lab technologist he knows how to draw the labs; he knows what the purple top for CBC with or without diff is; he knows EDTA ethylenediaminetetraacetic acid is, he knows the light blue top is gonna be sodium citrate for coagulation studies for prothrombin time etc.; he knows the red topper is maybe chemistry; so know those kinds of things, he knows how to perform venipuncture blood sample, finger stick and heel sticks. He had no history of cardiac problems other than what appears to be going on now; never been on anticoagulant before this hospitalization. He does not believe the chest pain, nausea and headaches are attributable to the vaccine; he is not going to say it couldn't be that; but on the surface he does not think the vaccine had anything to do with the events-events were going on before he got the bnt162b2. At the time he got the bnt162b2 he believes he mentioned having essential thrombocytosis and may have mentioned that he was an outpatient at that facility. He also mentioned he had mild tenderness of the injection site of right deltoid; but that is common and expected with any intramuscular injection; he did not notice any other types of side effects he could attribute to the vaccine. The mild tenderness of the injection site of right deltoid onset date and time was immediately or shortly after the time of injection on 18May2021 and only lasted about a day, stopped about 19May2021; event was nothing unusual. Unknown if recovered completely. Product name repeatedly verified by patient. Patient provided additional details from CDC vaccine record card: Vaccine first dose Covid-19 product name/manufacturer lot number: the following information was handwritten into the card by the people who administered the vaccine to him: Pfizer EW0172. Covid-19 vaccination record card. date administered: 18May2021. Facility: withheld-which he later referred to interchangeably as withheld. When he received initial dose on 18May2021, outside of the CDC vaccine record card, he was given future appointment card and a multi-page document all together titled Fact Sheet for Recipients and Caregivers; and in that information, that's how he came to call Pfizer. There's a telephone number inside, on page 5 of this document; in the section titled additional information it says if you have questions visit the website or call telephone number provided below: withheld that's how he got the number to call Pfizer. On page 2 of that same document section: What you should mention to your vaccination provider before you get the Pfizer-BioNTech Covid-19 Vaccine? Tell the vaccination provider about all of your medical conditions, including if you have any allergies, have a fever, have a bleeding disorder or are on a blood thinner, are immunocompromised or are on a medicine that affects your immune system, are pregnant or plan to become pregnant, are breastfeeding, have received another COVID-19 vaccine. What prompted him to call was on and before 18May2021 he had not been hospitalized; he was not having any bleeding disorder or on any blood thinner. He gets the first dose on 18May2021 he is scheduled for second dose on 08Jun2021 about 21 days after the dose at same place; what prompted the call today is, he was hospitalized with chest pains. During that hospital stay was on Heparin. He was not diagnosed with any bleeding disorder. He has no longer been on any blood thinner of any kind since 25May2021. So his question is given the fact that he is scheduled for the second dose,

Other Meds:

Current Illness: Essential thrombocytosis (Outpatient since 2015 for this condition/time of diagnosis May2014)

ID: 1405823
Sex: F
Age:
State: IN

Vax Date: 05/04/2021
Onset Date: 05/06/2021
Rec V Date: 06/17/2021
Hospital: Y

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Symptoms: Hip pain that turned into extreme pain that left me unable to sit, stand or put pressure on hip; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at 48-year-old, dose 2 via an unspecified route of administration, administered in Arm Right on 04May2021 17:30 (Batch/Lot number was not reported) as 2nd dose, single dose for covid-19 immunisation in Public Health Clinic facility. The patient medical history was not reported. Patient is not Pregnant at the time of vaccination. Patient received other medications within 2 weeks of vaccination (unspecified). the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient previously received the first dose of BNT162B2 (Pfizer, Batch/lot number: Unknown) at 48 years old into right arm on 12Apr2021 04:00 PM for COVID-19 Immunization. The patient experienced hip pain that turned into extreme pain that left her unable to sit, stand or put pressure on hip (hospitalization for 4 days) on 06May2021 08:00. AE resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. no covid prior vaccination. The patient underwent lab tests and procedures which included Nasal Swab post vaccination on 15May2021: negative. It was unknown if treatment received for the event. Outcome of the event was recovering. It was serious report. Seriousness criteria of Results in death, Life threatening, Caused/prolonged hospitalization, Disabling/Incapacitating and Congenital anomaly/birth defect were all No. Follow attempts are needed; further information has been expected.

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Current Illness:

ID: 1405824
Sex: M
Age:
State: FL

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Rec V Date: 06/17/2021
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Symptoms: He guesses the vocal cord is having swollenness so it's itchiest when he talks; muscle pain/ When he bends over his muscles burn; Swelling; regular pain were also where they put the injection; soreness in his limbs; Joint inflammation; soreness in his limbs like his shoulders, his pelvis, his hips and his knees/ his shoulders, his pelvis, his hips and his knees they when he bends over it burns; cough a lot when like the air is dry/ a slight cough that when he talk he get itch in his throat; it's itchiest when he talks/ when he talk he get itch in his throat; body aches/ When he bends over his body hurts; This is a spontaneous report received from a contactable consumer (patient). A 59-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number and expiration date unknown) via an unspecified route of administration at left arm (reported as left shoulder) on an unspecified date (unknown age at time of vaccination), at single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. There was no other vaccination within 4 weeks prior to the first administration. Patient stated he just wants to report some side effects that he had, he already had his second shot but after his first shot ,the third day after his first shot he had muscle pain, he has swelling and he means regular pain were also where they put the injection and also when he gets his second shot and doctor said not to get it because he was still in pain two weeks after and they give him a new date for two weeks after that when to get there, his vaccine and they gave it to him but it's been seven weeks and he is still having muscle pain, joint inflammation and soreness in his limbs like his shoulders, his pelvis, his hips and his knees and he developed a cough that's still it's been with him for like four weeks but the cough is very rare. He doesn't cough at night. He just coughs a lot when like the air is dry. He gets up onto an ER. He went to the doc, clinic and they send him to ER and they told him have the cough, the pain. The pain was because of the swollenness of the reaction. The cough is because of his swollen, he guesses the vocal cord is having swollenness so it's itchiest when he talks but like he said it hasn't gone away. They tell him it would take from two weeks to six months for side effects to go away. When he bends over his muscles burn. He doesn't know why. He never had the problem before. He got body aches. When he bends over his body hurts and he has a slight cough that when he talk he get itch in his throat and that's been like three weeks and but like his shoulders, his pelvis, his hips and his knees they when he bends over it burns. Adverse event started after vaccination, about seven weeks before reporting. It was after his first vaccine. Anatomical site of vaccination: Patient got both doses on his left shoulder. No lab test performed recently. Patient stated that the symptoms are getting better and better like he said since a week they haven't gone away yet completely. When probed for LOT#, patient stated his wife has got all the cards but she is not here. Therapeutic measures were taken as a result of the events and included steroids (He went to see his health, they gave him some steroids, the side effect went away for a week and as soon as he gets down on his steroids they came back. He is supposed to go to see his doctor tomorrow). The outcome of the events was recovering. Information on the lot/batch number has been requested.

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Current Illness:

ID: 1405825
Sex: U
Age:
State: CA

Vax Date: 05/18/2021
Onset Date: 05/01/2021
Rec V Date: 06/17/2021
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Symptoms: I started my menstrual cycle 2 weeks sooner; the menstrual cycle had a lot of blood clots, clots coming out.; I started my menstrual cycle 2 weeks sooner; the menstrual cycle had a lot of blood clots, clots coming out.; extremely itchy from head to toe; Rash almost like I don't know if it's hive or rash on my body and on my face; when I scratch to itch.; Rash almost like I don't know if it's hive or rash on my body and on my face; when I scratch to itch.; This is a spontaneous report from a contactable consumer (patient). A 34-years-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 18May2021 (Batch/Lot Number: EW0161) as single dose for COVID-19 immunisation. The patient medical history was none. No family medical history. Concomitant medication included escitalopram oxalate (LEXAPRO). No prior vaccinations within 4 weeks. On an unspecified date in May2021, the patient experienced extremely itchy from head to toe and rash almost like, patient didn't know if it's hive or as rash on body and on face which patient never gotten in life especially where patient scratch to itch. And patient started menstrual cycle 2 weeks sooner than it should started and the menstrual cycle had a lot of blood clots, clots coming out. Treatment in response to event included diphenhydramine hydrochloride (BENADRYL). The patient had a blood test (Jun2021) done just to check level of like vitamin D, vitamin b, full blood panel. Just a regular full blood panel. Outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.

Other Meds: LEXAPRO

Current Illness:

ID: 1405826
Sex: F
Age:
State: VA

Vax Date: 02/16/2021
Onset Date: 02/22/2021
Rec V Date: 06/17/2021
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Symptoms: Experienced upper left quadrant pain; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration in Arm Left on 16Feb2021 (at the age of 72 years old) as 1st dose, single dose for COVID-19 immunisation. Medical history included rheumatoid arthritis diagnosed 15 years ago, systemic lupus erythematosus diagnosed 20 years ago, Varying connective tissue disorders, avascular necrosis on the right side of the body, and blood cholesterol. Concomitant medication included methotrexate (METHOTREXATE) 20 mg every friday by mouth taken for rheumatoid arthritis, clopidogrel bisulfate (PLAVIX) 75 mg once a day taken for anticoagulant therapy, and rosuvastatin (ROSUVASTATIN) 20 mg once a day taken for blood cholesterol. On 22Feb2021 the patient experienced upper left quadrant pain. Reporter stated as She was taking methotrexate for rheumatoid arthritis and no one told her to stop it before receiving the vaccine. She experienced upper left quadrant pain that sent her to the emergency room three times but she was not admitted at any time. She would like to know if Pfizer has any reports similar to this with people who have autoimmune disorders. No information in pharmaceutical ingredient regarding reports of upper left quadrant pain in people with autoimmune disorders.According to pharmaceutical ingredient additional adverse reactions, some of which may be serious, may become apparent with more widespread use of the vaccine. She states her doctor told her not to receive the second dose after her reaction to the first dose. She would like to know how covered was she from receiving one dose. She would like to know after a certain amount of time can she restart the vaccine series without being on her methotrexate. No information in pharmaceutical ingredient regarding restarting the vaccine series after discontinuing methotrexate.The patient took covid vaccine as she did not want to get the virus and wanted to not spread it and for her family. She wants to know about the Pfizer covid vaccine. She got the first vaccine and she did really well for the first 3 days then found herself in the emergency room. She was in the emergency room with severe left upper quadrant pains and she has never experienced this in her lifetime. They ran tests and couldn't find anything. They found some minor little lung things that come with age. Everyone in her family- her children and husband has had both doses and done fine. She still has some slight pains but it stopped about a month ago. This event happened after the first dose of the vaccine.This happened in the middle of February. The patient inquired if after a certain amount of time can she start the shots over without taking the methotrexate. She did not receive the second dose of the covid vaccine.The patient underwent lab tests and procedures which included investigation: normal on an unspecified date and found some minor little lung things that come with age. The report assessed the event as non serious. Outcome of the event was recovered in 2021. Information on lot/batch number has been requested.

Other Meds: METHOTREXATE; PLAVIX; ROSUVASTATIN

Current Illness:

ID: 1405827
Sex: M
Age:
State: MN

Vax Date: 03/19/2021
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Rec V Date: 06/17/2021
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Symptoms: Did Xray found a big black spot on top of left side of stomach. dr said it was blood clot from the vaccine.; Severe stomach pain; This is a spontaneous report received from a contactable consumer (patient). This 68-year-old male patient received bnt162b2, dose 2 via an unspecified route of administration on 19Mar2021 (Batch/Lot number was not reported) as 2nd dose, single at the age of 68-year-old for covid-19 immunisation. The patient received the 1st dose of bnt162b2 on unknown date for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced severe stomach pain. Did Xray found a big black spot on top of left side of stomach. Dr said it was blood clot from the vaccine. Happened week after taking shot. The product was used by the patient. The outcome of event was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1405828
Sex: F
Age:
State: IN

Vax Date: 04/11/2021
Onset Date:
Rec V Date: 06/17/2021
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Symptoms: It was kind of like she was having some coughing; she was not feeling real good before she went to receive her second dose/stuff; This is a spontaneous report from a contactable consumer. This is case report for first dose. This 79-year-old female consumer reported for herself that who received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number and expiry date was unknown) via an unspecified route of administration on 11-APR-2021 (at the age of 79-years-old) as a single dose for COVID-19 immunization. Medical history included asthma and allergies that are chronic. Concomitant medication was not reported. The patient stated that on an unknown date her breathing was at 113 percentage breathing capacity (good) and the allergy specialist wanted her to go ahead and get the injection, which the patient did. The patient clarified that she received the first dose of vaccine and that she did really good with that one. The patient explained she was not feeling really good before she went to receive her second dose. It was kind of like she was having some coughing and stuff, but she thought it was not bad and that she could still go ahead and get it. The patient then received the second COVID vaccine on 13May2021. She came home and slept almost all night long and thought she was okay. Outcome of the events was she was not feeling real good before she went to receive her second dose/stuff and coughing was unknown. Information on the Batch/Lot number has been requested.

Other Meds:

Current Illness:

ID: 1405829
Sex: M
Age:
State:

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Rec V Date: 06/17/2021
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Symptoms: was reported that patient experienced:confirmed covid.; was reported that patient experienced:confirmed covid.; This is a spontaneous report from a non-contactable other healthcare professional (HCP). This non-contactable other HCP was reporting same events under the same suspect product for two patients. This is one of two reports. An around 50-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number and Expiration date were unknown) as the 2nd dose, single dose for COVID-19 immunization. The patient previously received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date for COVID-19 immunization. Relevant medical history included that the patient was obese and had multiple sclerosis (MS), both from an unknown date and unknown if ongoing. Concomitant medication included ocrelizumab (OCREVUS) taken for an unspecified indication, start and stop date were not reported. It was reported that patient experienced: confirmed covid on an unspecified date. It was further reported that there were two MS patients currently more than (>) 1 month post second vaccine (both Pfizer) with lab confirmed covid (positive); both with medically significant illness, neither required hospitalization. The outcome of the event was unknown. No follow-up attempts are possible, information about batch/lot number cannot be obtained. No further information is expected.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 cannot be excluded for reported "experienced: confirmed covid".,Linked Report(s) : US-PFIZER INC-2021641519 same reporter, drug, and event; different patient

Other Meds: OCREVUS

Current Illness:

ID: 1405830
Sex: M
Age:
State: NY

Vax Date: 05/14/2021
Onset Date: 05/14/2021
Rec V Date: 06/17/2021
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Symptoms: Blister-like hives appeared on tops of ears, then upper back and back of hand; Sore arm; Nausea; Fatigue; Tremors; Headache; Vomiting; This is a spontaneous report from a contactable consumer (patient). A 12-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number and Expiration Date: unknown), dose 1 via an unspecified route of administration, administered in Arm Right on 14May2021 09:00 as single dose for COVID-19 immunization. The patient medical history and concomitant medication was not reported. The patient previously had the known allergies included hives developed after 1 dose of amoxicillin and Azithromycin, hives present after several doses of m (as reported). The patient did not have the COVID prior vaccination and was not tested for COVID post vaccination. The patient did not receive other vaccine in four weeks. The patient received Multivitamin and Probiotic in two weeks. On 14May2021 at 01:00 PM, after the 4 hours of dose the patient experienced blister-like hives appeared on tops of ears, then upper back and back of hand. Then, sore arm, nausea, fatigue, tremors, headache through night. Following day continued with hives, headache, fatigue, sore arm, plus vomiting. Felt much better by the second day post shot. Just hives and arm soreness continued. The patient did not receive treatment for the events. On an unspecified date, the events nausea, fatigue, vomiting, tremors and headache were resolved. The outcome of blister-like hives appeared on tops of ears, then upper back and back of hand and sore arm were not resolved. Information on lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1405831
Sex: F
Age:
State: AZ

Vax Date: 04/24/2021
Onset Date: 04/24/2021
Rec V Date: 06/17/2021
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Symptoms: 3 weeks later she "couldn't move her left arm at the shoulder; shoulder pain and immobility; she had horrible pain; only had a little soreness at the injection site; the vaccine had been injected into the bursa and not the arm muscle; This is a spontaneous report received from a Pfizer sponsored program via medical information team. A contactable consumer (patient) reported a 36-year-old female patient received the second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0175, expiry date was unknown) via an unspecified route of administration, administered arm left (in the bursa in and not the arm muscle) on 24Apr2021 (at an age of 36-years-old) as 2nd dose, single dose for COVID-19 immunization. The patient medical history included migraines (from an unknown date in 1997 and current status: ongoing), Splenectomy (onset date: she was 18 years, caller reported that she is technically immunocompromised but hasn't been an issue. Caller reported that she had her spleen removed because of a bleeding disorder and removing her spleen took care of it), chronic pain (from: unspecified, current status: ongoing, in her left hip and back since after she had her left hip replaced when she was 20 years old), infection in femur (onset date: when she was 18, 19, or 20, after left hip replacement at age 20, current status: ongoing, Caller reported that she didn't have any symptoms of infection, the only thing going on was that the bone of her left femur was getting thinner and it was excruciating. Caller reported that all the tests were normal. Caller reported that she developed the infection while she was on prednisone during her recovery from hip replacement), depression (from: unspecified and current status: ongoing), left hip replacement (onset date: she was 20 years old, because the infection in her femur had spread to the joint), immunocompromised (but had not been an issue). The patient did not receive any vaccination prior vaccinations within 4 weeks. The patient's concomitant medication included oxycodone (MANUFACTURER UNKNOWN), via an unspecified route of administration, on an unspecified date in 2010 and ongoing, at 10 mg four times a day for chronic pain (the patient stated the patient took oxycodone during the colder months because her pain was more manageable and she took oxycodone during the hotter months because her pain was much worse); sumatriptan succinate (IMITREX) (MANUFACTURER UNKNOWN), via an unspecified route of administration, on an unspecified date at unknown dose and frequency for migraine (for migraines and it felt similar to that, like a bruise); escitalopram (MANUFACTURER UNKNOWN), via an unspecified route of administration, on an unspecified date in 2020 and ongoing at unknown dose and frequency for unknown indication; cyanocobalamin (VITAMIN B12) (MANUFATURER UNKNOWN), via an unspecified route of administration, on an unspecified date in 2020 and ongoing at unknown dose, once a day for unknown indication; ibuprofen (MANUFACTURER UNKNOWN), via an unspecified route of administration, on an unspecified date in 2020 and ongoing at 800 mg thrice a day for help with inflammation (but that the dose was cut back because she didn't need that high of a dose). The patient reported that she previously was prescribed RELPAX and IMITREX tablets for migraines (one times she was put on a beta blocker and something else combined that gave her major memory problems) and nuvaring for birth control. Historical vaccination included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0150, expiry date was unknown) via an unspecified route of administration, administered in injection at arm left on 04Apr2021 for COVID-19 immunization. On 24Apr2021, the patient experienced the vaccine had been injected into the bursa and not the arm muscle. On 25Apr2021, the patient experienced only had a little soreness at the injection site. On an unspecified date, the patient experienced 3 weeks later she "couldn't move her left arm at the shoulder, shoulder pain and immobility, she had horrible pain. Caller reported that the vaccine didnt go into her body so it crystallized. The patient reported that she had a little soreness at the injection site a day later after receiving the first dose BNT162B2 on 14Apr2021. The patient reported that the soreness at the injection site felt like a normal and she was unsure of when the soreness at the injection site went away because the soreness was so slight that it was not an issue. Second dose of BNT162B2 Covid-19 vaccine was administered 20 days after first dose. The patient reported that reported that she does 4 weeks at a time to skip her period. On 25Apr2021, the patient experienced with a little soreness at the injection site. The patient reported that she was fine following the vaccine, she waited 15 minutes and was good. The patient reported that she did not have any pain in her shoulder for 3 weeks and only had a little soreness at the injection site. She barely had a bump, and had no muscle soreness, fever, aches, or chills. The patient reported that she had no reaction either time to the Covid-19 vaccine. On an unknown date in May2021, (3 weeks later after second dose of vaccination) the patient suddenly could not move her left arm at the shoulder. The patient went emergency room/physician office for pain in shoulder, could not move shoulder. The patient stated that her shoulder felt exactly like her femur did at the time. She had horrible pain and was unable to move her shoulder. The patient reported that nothing was helping. The event could not move her left arm at shoulder was reported as worsened. The pain began traveling down her arm into her hand. The patient reported that she could not move it completely, but there was a lot that she could do all of the sudden. The patient stated that the shot was given higher than normal (one she had before in first dose). She went to the emergency room and the physician told her the vaccine had been injected into the bursa and not the arm muscle. The patient did not provide further details for other incidents where vaccines were injected into the bursa. The patient was given prednisone in the emergency room and a prescription to take continue taking the prednisone at home. The patient reported that about 12 hours after receiving the prednisone, her shoulder felt so much better. Patient reported that the pharmacy didn't have the prednisone until Friday, 28May2021. The patient did not take the prednisone again until Saturday, 29May2021, because the prednisone had kept her awake and she wanted to get a good night sleep. The patient took the prednisone on Saturday 29May2021, Sunday 30May2021, and Monday 31May2021. Caller reported that she should had also taken the prednisone on Tuesday 01Jun2021 and Wednesday 02Jun2021, but on Sunday 30May2021, she had horrible stomach pains from the prednisone. The patient reported that she took the prednisone on Monday, 31May2021, and it made things worse. The patient's PCP is prescribing another type of steroid for her to take. The patient asked steroid was safe to get the 2nd dose while taking another steroid. The patient reported that the pain in her shoulder was getting worse because she stopped taking the steroids and she was feeling almost back to normal before she stopped taking the steroids. The patient reported that some movements still cause twinges of pain in her shoulder and that the pain is going into her hand. The patient reported that she had a severe reaction to the second dose of BNT162B2. The patient also reported that the vaccine did not go into her body so it crystallized and in the emergency room gave her steroids in order to assist. The patient wanted to know since the second dose of BNT162B2 did not actually work if she can have it redone, and if it was safe to get the second dose of BNT162B2 vaccine while she was on steroids. The patient reported second dose of Covid-19 vaccine didn't work relevant tests was reported as none. The patient went to the emergency room a week ago today, 02Jun2021. The outcome of th

Other Meds: VITAMIN B12 [CYANOCOBALAMIN]; IBUPROFEN; OXYCODONE; IMITREX; ESCITALOPRAM

Current Illness: Chronic pain; Depression; Immunocompromised (but had not been an issue); Infection (onset date: when she was 18, 19, or 20, after left hip replacement at age 20. Caller reported that she didn't have any symptoms of infection, the only thing going on was that the bone of her left femur was getting thinner and it was excruciating. Caller reported that all the tests were normal. Caller reported that she developed the infection while she was on prednisone during her recovery from hip replacement.); Migraine

ID: 1405833
Sex: F
Age:
State:

Vax Date: 04/16/2021
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Rec V Date: 06/17/2021
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Symptoms: face droops; Migraines; This is a spontaneous report from a contactable consumer (patient) via a Pfizer Sponsored Program. A female patient of an unspecified age received second dose of bnt162b2 (BNT162B2), via an unspecified route of administration on 16Apr2021 (Batch/Lot number was not reported) as 2ND DOSE, SINGLE for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included testosterone taken for an unspecified indication from an unspecified start date and ongoing. The patient experienced side effects, migraines and face droops. The outcome of the events was unknown. Information regarding the lot/batch number has been requested.

Other Meds: TESTOSTERONE

Current Illness:

ID: 1405834
Sex: U
Age:
State:

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Rec V Date: 06/17/2021
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Symptoms: was reported that patient experienced:confirmed covid.; was reported that patient experienced:confirmed covid; low O2; Shortness of breath; This is a Spontaneous report from a non-contactable health care professional based on the information received by Pfizer(Manufacturer Control No: LRN4341875). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; ), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 2ND DOSE, SINGLE for covid-19 immunization. Medical history included multiple sclerosis from an unknown date and unknown if ongoing.. Concomitant medication included ocrelizumab (OCREVUS). On an unspecified date, The patient experienced :confirmed Covid, low o2, shortness of breath. The event were considered medically significant. Events of low 02 and shortness of breath required an emergency room visit.. The reporter states 'two MS patient now greater than 1 month post second vaccine (both Pfizer) with lab confirmed Covid. Both with medically significant illness, neither required hospitalization. The patient underwent lab tests and procedures which included sars-cov-2 test: lab confirmed covid on an unknown date. The clinical outcome of the events was unknown, No follow-up attempts are possible; information about lot batch number cannot be obtained. .

Other Meds: OCREVUS

Current Illness:

ID: 1405836
Sex: M
Age:
State: NC

Vax Date:
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Rec V Date: 06/17/2021
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Symptoms: not feeling good today at all; extreme fever reaching 100.4 F; This is a spontaneous report from a contactable consumer (friend). A 51-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 unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient went and got the shot yesterday he was not feeling good today at all. He has a temperature of 100.4. He had an extreme fever reaching 100.4 F. He took ibuprofen instead of Tylenol. The reporter was told to take Tylenol and asking if him taking Ibuprofen did that to him. He just went to eat. He should not have taken ibuprofen and was supposed to take Tylenol. The report was considered as non-serious by reporter. The outcome of events was unknown. Information on the batch/lot number has been requested.

Other Meds:

Current Illness:

ID: 1405837
Sex: F
Age:
State:

Vax Date: 05/13/2021
Onset Date:
Rec V Date: 06/17/2021
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Symptoms: she doesn't want to since she got very ill; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 13May2021 as single dose for COVID-19 immunization. Medical history included COVID from Feb2021 to an unknown date. The patient's concomitant medications were not reported. Patient stated she received the first dose of a Covid 19 vaccine on 13May2021, she was scheduled to get the second dose on 03Jun2021. She stated she heard she needs to quarantine for 14 days after receiving the second dose, but she needs to travel out of town on the 07Jun2021; and she was told that if she misses her appointment she should restart the series, which she doesn't want to since she got very ill on an unspecified date in 2021 and she also had Covid and was hospitalized for 10 days on February. She wanted to know if this information was true. Patient confirmed yesterday that she actually got the Pfizer vaccine. Before the vaccine, she had COVID and almost died. The outcome of event was unknown. Information related to batch/Lot no. was requested.

Other Meds:

Current Illness:

ID: 1405838
Sex: M
Age:
State: NJ

Vax Date: 04/18/2021
Onset Date: 04/01/2021
Rec V Date: 06/17/2021
Hospital: Y

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Symptoms: The heart rate was 245; A blood clot in the caller's neck; It was thought he might have lymphoma; Felt like he had a golf ball in his left arm/that little golf ball in his arm started traveling to his whole body- his back, his chest, legs, calves; Sweating; Didn't feel too great; Breathing was off/trouble breathing; Throat was hurting/sore throat; Neck was swollen; This is a spontaneous report from a contactable consumer. This consumer (patient) reported for himself that: A 38-year-old male patient received first dose of BNT162B2 (Solution for injection; Lot number: ER8131 or ER8231 and Expiration date were not reported) via an unspecified route of administration, administered in left arm on 18Apr2021 (at the age of 38-year-old) as first dose, single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 18Apr2021, he went to get the Covid shot through name withheld which Pfizer sponsors and it was done at name withheld. He went there and took the shot. He was told to wait 15 minutes and then left. When he got to car, immediately he felt like he had a golf ball in his left arm. The next couple of days, that little golf ball in his arm started traveling to his whole body. He felt it in his back, his chest, he felt it in his legs. Literally, in the next 3 days, he felt it literally travel through his whole body. He felt it in his calves, it was crazy also mentioned they felt sore or like ball in the arm. He started sweating and didn't feel too great. He thought it was standard side effects and didn't think much of it. A couple of days past by and then Thursday morning, he woke up and his breathing was very off. He clarifies his throat was hurting. He thought it was a sore throat and took some cough medicine and cough drops. Then the next day, it wasn't going away and was still hurting, wasn't getting any better. His breathing was very rough. If he was just standing still like laying down, then felt okay. But if went to move or do something it was very difficult. Again, expecting these symptoms, some people have said these symptoms and he didn't' think much of it. The next morning patient woke up and breathing felt fine. His neck was swollen. He thought maybe he had a sore throat or something. He was taking cough drops to soothe his throat the following day, the throat was still hurting, and it was the same. The patient called the doctor and did a telehealth. The patient told the doctor when he received the first dose Pfizer Covid Vaccine and all his symptoms. The doctor said it is a little unpredictable, nothing the doctor hasn't heard. He went to the doctor office the next day and was hooking to a nebulizer for breathing and prescribed an asthma pump. The doctor thought patient had Lymphoma in the neck. The doctor wanted to go the following day for an ultrasound. He went to the ultrasound and they checked the neck and immediately there were red flags. His heart rate was checked, and the heart rate was 245. The patient was hospitalized from 27Apr2021 to 08May2021. The minute they saw heart rate and started putting intravenous and received treatment to low down heart rate. The heart rate went down to 170 or 165. He had x-rays and a CAT scan done. He had fluids in his heart and fluid in the lung and a blood clot in neck. He had a hole cut open on left side to lungs and the lungs were drained. He went back to the ICU, they ran another CAT scan and X-ray and gave the medication. He does not know if this medication was antibiotics or what the medication was. The CDC received this information because the patient case was so rare. When the CAT scan and X-rays were run again, the fluid is right back up in the lungs. Then he was taken to surgery for the heart. An incision was cut from where itches is to back on the side, a very big incision. The heart was gone into to cut a little piece around the heart. Something was cut out so the heart could drain, and fluid could get out of the heart. While all of this is happening, he wasn't getting any better, was getting worse. The patient health deteriorated, breathing was about 10 percent and was hooked up to a breathing machine. He was sedated at that time and not awake anymore. The machine was keeping him alive. Now, every day for basically five days he was asleep and not knowing what was going on and was tested for Leukemia, cancer, and A to Z every disease you can think of to try to find common ground. Everything came back negative; nothing was wrong with the caller. He was given this or that medication every day and was sedated for about 5 days. Every day of the sedation was getting worse. He was dying and time was ticking. On the 5th day, everything was getting worse. The woman kicked everyone out of the room and went into his mouthpiece on the ventilator that was keeping the alive doing the breathing for the patient. The woman pulled something out of his lung. The woman started pumping him with steroids. What the woman took out of his lung stopped the fluid from going in. The fluid wouldn't fill back up in the lung. Once the woman started giving the steroids, the steroids killed the Pfizer Covid Vaccine. The steroids reversed the Pfizer Covid Vaccine. He was started breathing on his own again. After a couple of hours, the patient finally woke up. The patient is now recovered and has been home the past few weeks on a whole bunch of medication. He is on blood thinners, steroids, and stomach stuff. The outcome of the events was unknown. Information on Lot/Batch number was available. Additional information has been requested.

Other Meds:

Current Illness:

ID: 1405839
Sex: F
Age:
State: NJ

Vax Date: 05/02/2021
Onset Date: 05/02/2021
Rec V Date: 06/17/2021
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Symptoms: First shot - hives; This is a spontaneous report from a contactable Pharmacist (patient). A 53-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 02May2021 13:15 (Batch/Lot number was not reported) (at age of 53-year-old) as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included COVID-19 prior to vaccination. known allergies: Prior to the vaccine: aspirin, ibuprofen, MIT/CIT/BIT. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took methylisothiazolinone. The patient experienced hives on 02May2021 14:30 . The event result in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Therapeutic measures were taken as a result of hives included: at hospital anti-histaminic and anti-inflammatory.The outcome was not resolved. Since the vaccination, the patient has not been tested for COVID-19. Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021645254 same reporter/patient/product, different dose/event.

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Current Illness:

ID: 1405840
Sex: F
Age:
State: CA

Vax Date: 03/30/2021
Onset Date: 04/02/2021
Rec V Date: 06/17/2021
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Symptoms: Periodic chest pain/heaviness as well as occasional shortness of breathe; Periodic chest pain/heaviness as well as occasional shortness of breathe; periodic chest pain/heaviness as well as occasional shortness of breathe; Tingly sensations in my left arm; This is a spontaneous report from a contactable consumer (patient). A 39-years-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 30Mar2021 09:00 at the age of 39-years-old (Batch/Lot Number: EP7533) as 1ST DOSE, SINGLE DOSE for covid-19 immunisation. Medical history was None. There were no concomitant medications. The patient previously took cefalexin monohydrate (KEFLEXIN) and experienced allergies. There was no other vaccine in four weeks. There were no other medications in two weeks. The patient did not get covid prior vaccination. covid was not tested post vaccination. The patient stated she began to have tingly sensations in her left arm like it was 'asleep' from 02Apr2021. The tingly sensations started to move to her other limbs, and she went to see her neurologist (Name). He ran some test, blood work and an MRI of the Brain and no issues were found. In the last two to three weeks, she had been having periodic chest pain/heaviness as well as occasional shortness of breath from 02Apr2021. She went to the local urgent care; they did some blood test and again no issues found.Today she went to her neurologist to report her symptoms and he had made her an urgent cardiologist appointment for 3Jun2021. The events resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient underwent lab tests and procedures which included blood test: no issues were found, MRI Brain WO: no issues were found, nerve tests: unknown results, all on an unspecified date. The outcome of the events was not resolved.

Other Meds:

Current Illness:

ID: 1405841
Sex: F
Age:
State: OH

Vax Date:
Onset Date: 06/02/2021
Rec V Date: 06/17/2021
Hospital: Y

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Symptoms: I have severe allergies now because from the shot I almost died; shot made my allergies like ten times worse; I have severe allergies now because from the shot I almost died; shot made my allergies like ten times worse; I can't hear you my allergies are horrible today; Light-headed; Cough; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration at 1 O'clock on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included allergies from an unknown date. The patient reported I'm on five different pills, I don't have them right now I didn't take up from the pharmacy yet. The patient stated, "I had to go to emergency room last night and I had a reaction to the vaccine and I have severe allergies now because from the shot I almost died. I can't hear you my allergies are horrible today. I started now with a cough, I have severe allergies and this all I had to go to hospital. I'm still like light-headed and I'm coughing too much and I never done it until I got the COVID shot. The events started couple of days after the injection. The patient further stated, "I have severe allergies and they thought I have a blood clot in my lung and I still have nothing wrong with that, my lungs and heart are fine. It's this shot the shot made my allergies like ten times worse. Now I'm in like on five different pills now." The patient reported no treatment received for the events, only thing they did is they done a test in my lung and everything is fine, my heart is fine so I'm doing pretty good. The event Cough started on 02Jun2021; other events started on unspecified date. The patient was hospitalized for the severe allergies now because from the shot she almost died. The outcome of event Cough and Light-headed was not recovered, outcome of other events was unknown. Information on the lot/batch number has been requested.

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ID: 1405842
Sex: F
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Onset Date: 01/14/2021
Rec V Date: 06/17/2021
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Symptoms: patient experienced Covid-19; feeling ill; arm soreness; COVID-19; This is a solicited report from a Non-Clinical-Study (Facilitated Collect) based on information received by Pfizer from via AbbVie (manufacturer control number: 21K-163-3734456-00): A contactable consumer reported that a 44-year-old female received bnt162b2 (BNT162B2, Solution for injection ) intramuscularly on an unspecified date as single dose for COVID-19 vaccination and adalimumab (HUMIRA, Solution for injection in pre-filled pen) subcutaneously citrate free for psoriatic arthritis and currently discontinued. Medical history reported and concomitant medications were not reported. On unknown dates, the patient experienced feeling ILL and arm soreness. On 14Jan2021, the patient experienced COVID 19. In 2021, the COVID 19 resolved. On an unspecified date patient underwent COVID-19 test with Positive result. The outcome of events COVID-19 was recovered and for remaining events its unknown. The reporters causality for the events of feeling ill, covid 19 and arm soreness with HUMIRA was no reasonable possibility and with BNT162B2 it was not reported. No follow-up attempts possible. No further information expected. Information about lot/batch number has been requested.; Sender's Comments: Based on the known safety profile, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported Covid-19

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ID: 1405843
Sex: F
Age:
State: NJ

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Onset Date: 05/19/2021
Rec V Date: 06/17/2021
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Symptoms: hemorrhagic cyst; Breast pain and tenderness began after 2nd shot; Breast pain and tenderness began after 2nd shot; uterine tract infection; abdominal pain; swelling; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 57-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on an unspecified date (also reported as on 28Mar2021, pending confirm) (Batch/Lot Number: ER8731) as 2ND DOSE, SINGLE for covid-19 immunization, at the age at vaccination of 57 years old. Patient was not pregnant. Medical history included Colon surgery in 2017, followed by colon cancer chemotherapy in 2017- 2018, follow up CT scans performed every 6 months. CT scan on 04Apr2021 showed no observation of cyst on ovary. Historical vaccine included first dose of COVID 19 vaccine (Brand: Pfizer; Lot number: ER8733; Vaccine location: Left arm) on 28Mar2021 11:00 AM). Concomitant medications included cetirizine hcl (CETIRIZINE HCL) 10 mg taken for an unspecified indication, start and stop date were not reported. The patient experienced hemorrhagic cyst (medically significant), breast pain and tenderness began after 2nd shot, uterine tract infection, abdominal pain, swelling, all on 19May2021 with outcome of not recovered. The patient underwent lab tests which included CT scan: no observation of cyst on 04Apr2021, ultra sound Retroperitoneal of uterine, ovaries, kidneys, bladder, a complex lesion was identified in right ovary measuring 14.3 x 15.7 x 8.2 cm on 25May2021. Adverse event reported as: Breast pain and tenderness began after 2nd shot and lasted approximately 30 days. On 19May2021 had symptoms of uterine tract infection, abdominal pain, swelling. On 25May2021, primary care doctor ordered an ultra sound Retroperitoneal of uterine, ovaries, kidneys, bladder and a complex lesion was identified in right ovary measuring 14.3 x 15.7 x 8.2 cm, may represent a hemorrhagic cyst. Left ovary not visualized. Followup is planned with gynecology surgeon. AE resulted in: Doctor or other healthcaremprofessional office/clinic visit. The treatment received for events included: antibiotic to treat infection. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Additional information is requested.

Other Meds: CETIRIZINE HCL

Current Illness: Chemotherapy (followed by colon cancer chemotherapy in 2017- 2018)

ID: 1405844
Sex: F
Age:
State: PA

Vax Date: 05/15/2021
Onset Date: 05/01/2021
Rec V Date: 06/17/2021
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Symptoms: Dizziness/lightheadedness; Nausea; Blurred vision; Terrible headache; a little palpitation; Clogged throat; this heaviness (not clarified); This is a spontaneous report from a contactable consumer (parent). A 15-years-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 15May2021 16:00 (Batch/Lot Number: EW0182) as single dose for COVID-19 immunisation. Medical history included no other illness. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and any other medications 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. The patient previously received Amoxicillin, Azithromicin, Cefdinir, Gardasil(Pf) and had allergy. The patient had Nausea that does not go away with Gardasil. She also received HPV vaccine previously and experienced nausea and the dizziness for a month. Reporter stated, "she did not have any allergic 'condition' (not clear) but she was allergic, she had always had a rash when she had this Amoxicillin this antibiotic. She was allergic to Penicillin." The patient had the COVID Pfizer Vaccine on 15May2021 and as soon as she had her first dose she started to feel nausea and dizziness and from there 5 days later she had, she felt a terrible headache, 'this heaviness' (not clarified), headache, dizziness, palpitation. The reporter took her to the emergency room, they did all the test and they didn't really see anything in the results. From there she cannot stop to have nausea and dizziness and clogged throat so the reporter had to give allergy medication to her every day. She did have, she never had an allergic reaction to any vaccine but the HPV vaccine (captured as unspecified vaccine in tab) what was similar to what she is experiencing now. She had nausea and the dizziness for a month that she couldn't stay in school and she has this nausea and dizziness and clogged throat she has to run for this allergy medication what normally she never needed. So, she doesn't want to take this second dose and the reporter was wondering if it is Pfizer because she was just like (Height), a (Weight) pounds if because the reporter understand the vaccine is one for everybody, isn't this strong for a kid with that height that weight, that you do not needed the second dose. The patient could not she said she will not because she goes to school and she feel the nausea and dizziness and so. The reporter would like to report it because it maybe Pfizer's that she was thinking that 1 dose would be enough for kids. When asked about the start of experiencing adverse events, the reported stated that "Well the nausea and dizziness, she was a little bit not sure about like headache right after like her we stayed there like half hours because the doctor said to stay there because she has her reaction to which but then we just the reporter felt the nausea and everything was so bright you know, the reporter had the same effect but her went away and the patient after we received she was, the whole day but not too bad, 5 days after then she but she was already with this nausea, dizziness and 5 days after she got the palpitation, bad headache, nausea, dizziness and then I took her to the emergency room." Reporter stated, "No they have improved, the only thing now left is every day she has this nausea, dizziness and then she said about dizziness and then nausea and then clogged throat and then the reporter gave her the 'allergic pill I gave that, to this allergy' (not clarified further) really she gave only 1 tablet a day." Reporter stated, "On 20May2021, they did a blood test, they did urine test, they did a ECG, so the hospital did all and the doctor too, nothing new." The reporter had lab test result on chart, she stated they put on her chart but she also had the copy of the results. Okay, here they put the result is a line on the chart. Okay here they put like linear line lab test complete, she get all the line because here they didn't put results but screen for metabolic and kidney disorder they did, they did an 'urinary tract infection' (not clarified) they have marked in the ECG. Okay you going to ask for specific (incomplete sentence)." The patient had no other illness but reporter need to know what Gardasil and Covid 19 vaccine have in common because the symptoms were very similar. Nausea that does not go away. She asked if it is the preservative or what ingredients. Never had a reaction to any other vaccine. She just wanted to call the Medical Department if she should have the vaccine on Saturday or not. On 15May2021, 4:30 AM, the patient experienced dizziness, nausea, lightheadedness, blurred vision, headache, a little palpitation (as reported). The patient received treatment Children allergy medication. Adverse events resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Outcome of the events clogged throat, heaviness was unknown and other events was not recovered.

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Current Illness:

ID: 1405845
Sex: F
Age:
State: FL

Vax Date: 02/20/2021
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Rec V Date: 06/17/2021
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Symptoms: Heart palpitations; Rash on right arm; Itching; This is a spontaneous report received from a contactable consume(patient). A 65-year-old female patient received second dose of bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: EN6200, Expiration date: UNKNOWN), via an unspecified route of administration in right arm on 20Feb2021 (at the age of 65-years-old) 1ST DOSE SINGLE DOSE as single dose for COVID-19 immunization. The patient medical history is reported as none. The concomitant medications were not reported. The family medical history relevant to AE(s) was not provided by the reporter. The patient did not receive any other vaccines within 4 weeks prior to the covid vaccine. It was reported that no history of all previous immunization with the Pfizer vaccine considered as suspect and no additional vaccines administered on same Date of the Pfizer Suspect. The Historical vaccine taken was first dose of BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE Solution for injection, Batch/Lot Number: PFR, EN5318, Expiration date: UNKNOWN), via an unspecified route of administration in right arm on 28Jan2021 between 10 am and 1pm, midday, during the day(at the age of 65-years-old), and experienced a breakout of a rash on the arm where she was given the injection, it then went away and getting scabs and lesions, within 24 to 48 hours, after the first vaccine. On an unspecified date after her second dose, the patient experienced Rash on right arm and Itching, right arm and she also experienced heart palpitations on an unspecified date. The reporter reported many details, which included that she works out, eats well and is in tune with her body she is aware of the palpitations, and attributes that to the vaccine states she had read documentation that heart arrhythmia is being noted as a side effect of people who have gotten the vaccination and stated that she is unsure of the exact date, but it was close to the time of the second vaccine on 20Feb2021 she thought it would go away over time, but she is still getting palpitations, the rash as it started with the first vaccine and then went through until after the second vaccine it went away, but stayed for a good month. She wants to clarify that the rash was all the way down her arm and states she still has a little bit of the rash left on her forearm, but it is very minimal and itching after first and second vaccine, stated as approximately early evening as it is very minimal on her right arm and as it was lingering. The AE(s) did not required the visit of Emergency Room or Physician Office. The relevant tests are reported as none. The outcome of all the events was reported as resolving. Follow-up attempts are possible. Further information is expected.

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Current Illness:

ID: 1405846
Sex: U
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Vax Date: 05/29/2021
Onset Date: 05/30/2021
Rec V Date: 06/17/2021
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Symptoms: Arm that hurt; I can barely move my arm, I can barely lift it, it is like a dead arm/The pain is like un-bearable; Arm that hurt; I can barely move my arm, I can barely lift it, it is like a dead arm/The pain is like un-bearable; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 29May2021 (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 stated, I have my vaccination my second dose on Saturday, you know I have an arm that hurt but since then apparently I don't know really what happened but I can barely move my arm, I can barely lift it, it is like a dead arm. I do go to the urgent care because the pain is like unbearable. The events occurred on 30May2021; outcome of events was unknown. Information about batch/lot number has been requested

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Total 2021 VAERS Injuries: 679,999

Page last modified: 03 October 2021 5:28pm