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**
PLEASE CHECK BACK SOON
Download the files above while you wait.






Manufacturers

Total Manufacturer

Incidents per State

State Total
92,076
AK1,880
AL6,345
AR4,151
AS46
AZ14,991
CA66,887
CO12,550
CT8,943
DC1,795
DE2,009
FL42,724
FM4
GA17,031
GU124
HI2,580
IA4,919
ID2,892
IL22,128
IN24,197
KS5,047
KY9,111
LA5,500
MA15,718
MD13,434
ME3,351
MH8
MI20,971
MN13,585
MO10,747
MP30
MS3,198
MT2,477
NC18,051
ND1,501
NE3,109
NH3,218
NJ20,216
NM4,218
NV4,728
NY37,667
OH20,793
OK6,692
OR9,244
PA25,607
PR2,588
QM2
RI2,163
SC7,261
SD1,282
TN10,445
TX39,890
UT4,618
VA15,980
VI67
VT1,830
WA16,071
WI12,042
WV2,571
WY926
XB5
XL1
XV2

ID: 1442609
Sex: M
Age:
State: IN

Vax Date: 05/26/2021
Onset Date:
Rec V Date: 07/02/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: insomnia started getting worse; he gets so tried; his body start 'jerking'; feels like he is suffocating; it's like somebody is choking him/choking sensation/feels like somebody has his thumb in the middle of his adam's apple and his throat; light headed; This is a spontaneous report from a contactable consumer (patient's mother). A 40-year-old male patient received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number and expiry date unknown), via an unspecified route of administration on 26May2021 as the 2ND dose, single for COVID-19 immunization. Medical history included ongoing ventricular tachycardia. Concomitant medication included amiodarone (manufacturer unknown) taken for ventricular tachycardia, start and stop date were not reported, taking the highest dose (as reported). The patient previously received the first dose of bnt162b2 (lot number and expiry date unknown) on 03May2021 for COVID-19 immunization and right after the patient experienced insomnia and cough. When the patient went back to his second vaccine, his insomnia started getting worse. He can't sleep at all and when he does fall asleep it is only for 2 hours and he gets so tired, his body starts 'jerking' and it makes him wake up. Since the second vaccine, the patient said it's like somebody is choking him, he said it feels like he is suffocating and he said it feels like somebody has his thumb in the middle of his adam's apple and his throat and so they send him to the emergency room and they told him to go home and just take sleeping pills. However the reporter stated that the patient can't take the sleeping pills because of his ventricular tachycardia and the medicine that he is on. They were getting the patient setup for his test the following morning from the day of the report and when he woke the morning of the day of the report he experienced the choking sensation and all that kind of stuff but he is light headed and they don't know if he should be taken to that test the following morning but yes the test is really important because of his heart and they don't know if he can take the medication that they are going to give a 'nuclear' medication with having all these side effects like these if it is from the Pfizer vaccine so that was why the patient's mother was reaching out for somebody with medical knowledge about the vaccine and the side effects and if someone could tell them if the patient could continue with his test. They wanted to know how long the side effects will last and if the side effects need treatment. The patient had a lab test (unspecified) and a chest x-ray both on unspecified dates but they did not have the results at the time of the report. The outcome of the events was unknown. Information on lot number/batch number was requested.

Other Meds: AMIODARONE

Current Illness: Ventricular tachycardia

ID: 1442610
Sex: F
Age:
State: NY

Vax Date: 03/29/2021
Onset Date: 03/29/2021
Rec V Date: 07/02/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: Headache; Extreme body fatigue; Muscle aches; Had difficulty sitting up or lying down unless lying on a hard floor; Felt like I was going to pass out; Heart palpitations; Two panic attacks; Chest pains/Felt like heart attack; Shortness of breath/Felt like heart attack; Increased severe anxiety; Depression; This is a spontaneous report from a contactable Healthcare Professional. A non-pregnant 51-years-old female patient received the second dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine administered via an unspecified route of administration, in left arm on 29Mar2021 10:15, at 51 years of age, (Batch/Lot Number: ER8733) as single dose, for COVID-19 immunization. Medical history included hyperthyroidism, allergy to shrimp, menopause and allergy to IV dye, all from an unknown date. Historical vaccine included the first dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine (Batch/Lot Number: EN6206) on 08Mar2021 10:00 AM, at 51 years of age, administered in left arm. Concomitant medications included levothyroxine 25 mcg, progesterone and estradiol, all taken for an unspecified indication, since an unknown date. The patient didn't receive any other vaccine in the previous 4 weeks. She wasn't diagnosed with COVID-19 before vaccination. The patient reported that on 29Mar2021, after the second dose she had severe headache; extreme body fatigue; muscle aches; and had difficulty sitting up or lying down unless lying on a hard floor for the first 3-4 days after vaccine. For 3 weeks she continued to have severe continual headache; extreme body fatigue where if she tried to exercise or simply walk dog or go up flight of stairs she felt like she was going to pass out; she also had heart palpitations and two panic attacks, all of these symptoms lasted 3 weeks after vaccine. She went to the emergency room twice: once for headache and chest pains (as she felt like heart attack); second time it was for shortness of breath, again she felt like heart attack, she had to call for an ambulance. All these instances increased severe anxiety and panic and interfered with her work and daily functioning until 24Apr2021. She then began to feel herself again. However, she was still experiencing anxiety, depression, and panic at times. The patient underwent lab tests and procedures on an unknown date in 2021, which included CT scan, chest X-ray and EKG, with unknown results. The patient was tested for COVID-19 via nasal swab on 23Apr2021, which was negative. The patient was treated with headache medication. The events headache, extreme body fatigue, muscle aches, had difficulty sitting up or lying down unless lying on a hard floor, felt like i was going to pass out, heart palpitations, chest pains and shortness of breath recovered with sequelae on an unknown date, whereas the events two panic attacks, increased severe anxiety and depression had not resolved yet at the time of the report.

Other Meds: LEVOTHYROXINE; PROGESTERONE; ESTRADIOL

Current Illness:

ID: 1442611
Sex: F
Age:
State: NM

Vax Date: 05/04/2021
Onset Date: 05/04/2021
Rec V Date: 07/02/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: Extreme bout of Raynaud's (primary) in right hand; This is a spontaneous report from a non-contactable consumer (patient). A 61-year-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 vaccine), via an unspecified route of administration, administered in Arm Left on 04May2021 08:30 (Batch/Lot Number: EW0150) as unknown, single for covid-19 immunisation. Medical history included very occasional Raynaud's (primary) usually in chilly conditions. The patient concomitant medication was not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, was the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. On 04May2021 09:30, the patient experienced extreme bout of Raynaud's (primary) in right hand. The patient reported it was probably triggered by very brief visit to frozen section of grocery store. The patient reported that her fingers numb and turned dark blue (rather than the usual white) and base of thumb also turned dark blue and feeling numb. The patient drive home and applied warm water, which relieved attack. The patient stated that it was first time in 40 years she had a Raynaud's attack that has been swift and severe. The outcome of the event was recovered on unspecified date in May2021. Information on Lot/Batch number was available. Additional information has been requested.

Other Meds:

Current Illness:

ID: 1442612
Sex: F
Age:
State: NY

Vax Date: 05/14/2021
Onset Date: 05/19/2021
Rec V Date: 07/02/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: tested positive for Covid; This is a spontaneous report from a contactable consumer (wife). A 58-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: Unknown, Expiration date: Unknown), via an unspecified route of administration on 14May2021, as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On 19May2021, 5 days after vaccination, the patient was tested positive for COVID. She received her first COVID vaccine on 14May2021 but was exposed to COVID on the same day. The reporter asked for guidance on when she can receive her second vaccine dose. The reporter stated that they already spoke with her HCP who instructed her to get the second dose as soon as possible. The patient underwent lab tests and procedures which included SARS-COV-2 test: negative on 12May2021, SARS-COV-2 test: positive on 19May2021. The clinical outcome of the event was unknown. Information about lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1442613
Sex: M
Age:
State: SC

Vax Date: 06/01/2021
Onset Date:
Rec V Date: 07/02/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: little murmur in [his] heart; This is a spontaneous report from a contactable consumer(patient). This 84-year-old male patient received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EW0158) on 01Jun2021 via an unknown route in right arm at 84-year-old for Covid-19 immunization. Medical history and concomitant drug were not provided. Historical vaccine included 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EW0150) on 11May2021 at 84-year-old for Covid-19 immunization. Patient had an echocardiogram scheduled this Wednesday, 06Jun2021, and further reported had scheduled for an echocardiogram on 09Jun2021; due to a "little murmur in [his] heart", which his doctor noted during his physical exam a couple days ago. The Patient stated that he heard from other people that they don't recommend any other scans after receiving the second dose of the vaccine, and inquired if it's safe in getting his scheduled echocardiogram. Outcome of the event was unknown.

Other Meds:

Current Illness:

ID: 1442614
Sex: F
Age:
State: TX

Vax Date: 06/02/2021
Onset Date: 06/01/2021
Rec V Date: 07/02/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: Broke out in a rash on my face and it was very itchy, it was all in the lower area, it was pretty heavy and it itched/I woke up itching my face; scratching; Broke out in a rash on my face and it was very itchy, it was all in the lower area, it was pretty heavy and it itched/ like a red rash and it was all below my eyes going from ear and behind my ear; is that shingles because I had shingles before but very mild (not clarified further) but this is pretty red.; I was like tired; I was sleepy; I do not feel like I have a fever but my face is very warm; I checked the temperature, it was 97.1 and normally, my temperature runs lower than 97, usually my temperature runs 96.1; was broken out and it is almost like welt; This is a spontaneous report from a contactable consumer. A 75-year-old female patient received first dose of BNT162B2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 02Jun2021 at 12:05 (Batch/Lot Number: EW0191; Expiration Date: 02Jun2021) as DOSE 1, SINGLE for covid-19 immunization. Medical history included bad tooth, urinary tract infection and shingles from unknown dates and covid-19 and pneumonia from Nov2020. Concomitant medications included amoxicillin (AMOXICILLIN) taken for bad tooth, start and stop date were not reported and ciprofloxacin (CIPROFLOXACIN) taken for urinary tract infection, start and stop date were not reported. Consumer stated, "I got my COVID shot on 02June2021, Wednesday and my shoulder didn't even hurt it didn't get red, nothing, I felt great and then the next day Thursday I felt fine. And then yesterday morning I broke out in a rash on my face and it was very itchy, it was all in the lower area, it was pretty heavy and it itched. And then this morning it's still, I put Aloe Vera on it yesterday and it calmed it down and it felt better, it wasn't itching anymore but this morning I woke up and it's still there and it's 'welt' looking today. For her Medical Condition, Consumer stated, "Yes, I am, I have bad tooth in my mouth and I have to have it pulled and I have been on antibiotics for a week I guess. I might also mention that I had COVID in November last year and my doctor asked me to wait for 6 months before I got the shot. I had my blood work in December and everything is good. Ya everything is normal except my triglycerides are too high." Consumer stated, "I was sleepy when I got my home from getting shot, I was like tired, so I laid down on couch and rested and I have been fine and started talking. I had no side effects, no side effects, I talked about it too much. This Saturday, I woke up itching my face, scratching and I looked in mirror and I was broken out like a red rash and it was all below my eyes going from ear and behind my ear and it itches all across my face. I broke out in a rash and today, it is worse. Today, I put some aloevera on it and it helped and it saved it otherwise I just keep scratching my face of. I didn't have fever, I checked the temperature, it was 97.1 and normally, my temperature runs lower than 97, usually my temperature runs 96.1 or something like that, I do not feel like I have a fever but my face is very warm and was broken out and it is almost like welt. I did had Covid back in November and I was very sick then, I was in the hospital, they did take me to the hospital to get an X-ray and I did have spotted pneumonia but I don't even remember that week, I was ill. So, before I got my shot, I told them that I had urinary tract infection and I also have bad tooth and it has to be pulled (Consumer had urinary tract infection and bad tooth before getting the vaccine)and I have been on strong antibiotics (Unspecified Medications) for the whole week until I got my shot, I still was taking like 25mg of antibiotics per day for two different infections but the antibiotics works with each other and they said, I can go ahead and take my shot, it would be fine. The only thing that I am wondering is that, if it could have triggered this, I do not know. Also, I am wondering, is that shingles because I had shingles before but very mild (not clarified further) but this is pretty red. Could it be possibly be a reaction to the vaccine?" The patient underwent lab tests and procedures which included blood test: normal on Dec2020, blood triglycerides: high on Dec2020, body temperature: 97.1 on Nov2020 and x-ray: pneumonia on Nov2020. Therapeutic measures were taken as a result of broke out in a rash on my face and it was very itchy, it was all in the lower area, it was pretty heavy and it itched/ like a red rash and it was all below my eyes going from ear and behind my ear/i woke up itching my face. The outcome of the events was unknown. Information on Lot/Batch number was available. Additional information has been requested.

Other Meds: AMOXICILLIN; CIPROFLOXACIN

Current Illness:

ID: 1442615
Sex: M
Age:
State: PA

Vax Date: 05/27/2021
Onset Date: 06/01/2021
Rec V Date: 07/02/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: fever of 102, fever was getting higher as 102.6; fatigue; headaches; This is a spontaneous report from a contactable consumer (patient) from Pfizer sponsored program COVAX US Support. This 42-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via intramuscular in left arm on 27May2021 at 14:00, at patient age of 46-year-old, as single dose (Lot number EW0178, Expiry Date: Aug 2021) for COVID-19 immunization. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had no other medical history and no known allergies. The patient's concomitant medications included gabapentin, quetiapine fumarate (SEROQUEL), chloroquine. The patient had no past drug reaction. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced the adverse events from 01Jun2021. The patient got a high fever of 102 which had lasted a week and it was not getting any better. The patient also experienced headache and fatigue. The patient went to the emergency room on 07Jun2021, where they did blood work and a chest X-ray and a CT scan. Everything came back normal and they can not figure out why he had this persistent high fever. The patient wanted to know how long this is going to last or what was going on. On 08Jun2021, the patient reported fever was getting higher as 102.6. It was going up little more everyday. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Covid test post vaccination included Rapid test on 05Jun2021 showed negative (Nasal Swab); Non rapid test on 07Jun2021 showed negative (Nasal Swab). The patient received treatment including paracetamol (ACETAMINOPHEN), ibuprofen (MOTRIN), Ibuprofen. The outcome of the events was not resolved.

Other Meds: GABAPENTIN; SEROQUEL; CHLOROQUINE

Current Illness:

ID: 1442616
Sex: F
Age:
State: MI

Vax Date: 05/28/2021
Onset Date: 05/28/2021
Rec V Date: 07/02/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: extreme discomfort in her chest; liver enzyme that normal is 40 and it was 110; Dose Number : 1; Date of start of drug: 16Apr2021; Dose Number : 2; Date of start of drug: 28May2021; This is a spontaneous report from a contactable consumer (patient's mother). This is the second of two reported. This report concerns events occurred after the second dose. A 16-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EW0180), administered in left arm, on 28May2021 at 18:00 (at the age of 16-years-old) at dose 2, single for COVID-19 immunization. The patient was not pregnant. Medical history included ichthyosis vulgaris. No COVID prior vaccination and no COVID tested post vaccination. The patient had not known allergies. Concomitant medications were not reported. No other vaccines were received in four weeks and no other medications in two weeks. The patient received the first dose of BNT162b2 (lot number: EW0164) on 16Apr2021 at 13:30, at the age of 16-years-old, administered in right arm for COVID-19 immunization and experienced extreme radiating nerve pain in her arm to her fingertips. The reporter purposely waited 6 weeks for her second vaccine because she had adverse reactions to her first. The patient suffered extreme discomfort in her chest on 01Jun2021 at 03:00 AM. She described it as something sitting on her chest not allowing air in at a level 7 w 10 being dead. She had been taken to emergency room (ER) immediately. There she received an EKG, heart and lung scan and bloodwork on 01Jun2021. All that showed up was a liver enzyme that normal was 40 and it was 110, on 01Jun2021 at 03:00 AM. No treatment was administered in response to the events. The events were reported as non-serious and they required emergency room/department or urgent care visit. The patient had recovered from the events extreme discomfort in her chest and liver enzyme that normal is 40 and it was 110 in Jun2021, the outcome of the other event was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021669577 same patient/drug, different doses/events

Other Meds:

Current Illness:

ID: 1442617
Sex: F
Age:
State: KS

Vax Date: 06/07/2021
Onset Date: 06/07/2021
Rec V Date: 07/02/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: Her arm is just sore this time and she is tired; Her arm is just sore this time and she is tired; His daughter received twice the dose/ They put two and a half dosage given and they didn't diluted it correctly; They put two and a half dosage given and they didn't diluted it correctly; This is a spontaneous report from a contactable consumer (patient's father/ parent). A 15-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 07Jun2021 (9:00 or 09:10 this morning AM) (Lot Number: EW0180; Expiration Date: 01Aug2021) as single dose (at the age of 15-years-old) for COVID-19 immunization. Medical history included allergic to peaches. There were no concomitant medications. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 17May2021 16:00 (Lot Number: EW0167) as single dose (at the age of 15-years-old) for COVID-19 immunization. The patient received the second dose today (of the vaccine) and father was notified by the pharmacist that she received twice the dose of the vaccine today. The pharmacist called and said they put two and a half dosage given and they didn't diluted it correctly. Her arm is just sore this time and she is tired. She got her first shot and it was fine then. The patient underwent lab tests and procedures which included body temperature: fine on 07Jun2021. The patient did not receive any treatment for the events. The outcome of the events was unknown. The events were assessed as non-serious. The patient did not have any other vaccine after COVID vaccine.

Other Meds:

Current Illness:

ID: 1442618
Sex: F
Age:
State: IL

Vax Date: 05/30/2021
Onset Date: 05/30/2021
Rec V Date: 07/02/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: similar to extreme allergy/ felt like she was having an allergic reaction; Couldn't breathe/ because of so much stuffy nose/ felt like she was drowning; Stuffy nose/ Nasal congestion; Runny nose; Sneezing; Sore throat; Dry cough; wasn't feeling well; Headache; This is a spontaneous report from a contactable consumer (patient). A 36-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW018U) via an unspecified route of administration at left arm (near shoulder) on 30May2021 10:00 (36-year-old at time of vaccination), at single dose, for COVID-19 immunisation. The patient's medical history included birth control. Concomitant medications included "Aurobindo" (unspecified) taken once a day for birth control (Has been taking about a year and a half). The patient previously received flu shot and experienced sick for a month (7 years ago). There was no history of all previous immunization with the Pfizer vaccine considered as suspect. There were no additional vaccines administered on same date of the pfizer suspect. There were no other vaccinations within four weeks prior to the first administration date of the suspect vaccine. Patient states she did her first vaccine on Sunday in the morning and then by the end of day, she wasn't feeling well (From 30May2021). Thought this was normal and in a couple days would go away and it's Friday. Patient states it started Sunday with headache (From 30May2021) then a couple days of sore throat (From 31May2021), then similar to extreme allergy. States she had stuffy nose (From 02Jun2021), it was running (Runny nose from 02Jun2021), it was so bad. And patient states on the day of reporting it looks like it's going down, but headache how it happened the first day is coming back. States headache is so strong and ibuprofen doesn't help, she tried Dayquil it doesn't help, Vicks, nothing. Clarifies Vicks that you apply on chest. Patient states she was not sick before, not at all. States she was completely healthy before, no flu, no cold, and what's happening now, she has no idea. It's been five days sick and she doesn't know what to do. Event details: Patient states it was middle of the day on the day of vaccine when she had strong headache, then after was the sore throat and pain was so strong she couldn't tolerate from both the headache and sore throat that she could not tolerate. Patient states she doesn't usually take medicine at all. The headache went away on Monday, and instead of headache she experienced sore throat until Tuesday, and then Wednesday, she felt like she was having an allergic reaction- she was sneezing (From 02Jun2021), her nose was running, constantly, and she couldn't breathe (From: 02Jun2021), it was so much, she felt like she was drowning. She couldn't breathe because of so much stuffy nose. Clarifies headache got better and has came back on the day of reporting and still persisting. She doesn't have sneezing and runny nose, they went away Thursday evening (03Jun2021). Patient states she doesn't have stuffy nose, but is speaking strangely, nasal, talking through the nose and describes as nasal congestion. Patient confirms she only has nasal congestion and headache on the day of reporting and adds she has a dry cough (From 30May2021), that doesn't really bother her, that started on Sunday 30May2021. Patient is unsure of times of onset, states she knows when she gets up that it exists, headache on the day of reporting started a couple hours away. Patient states her question is what does she do now. It's been five days, do we want her to wait another five days to see what's gonna happen, or what? Adverse events did not require a visit to emergency room or physician office. Treatment: Clarifies ibuprofen is Motrin, Manufacturer: Johnson and Johnson Consumer Inc; Strength: 200 mg tablets; Count: 225 tablets. Patient states took two a day for headache and then for sore throat when she couldn't tolerate the pain. Lot: OGE2850A (Patient unsure if it is an O or 0), Expiration date: May2022. Zyrtec: States on Wednesday when she had extreme allergies, she took Zyrtec. Patient reports it helped a little, but not much, but later states it did help runny nose and sneezing, and confirms both symptoms have resolved. Clarifies runny nose was like Niagara, and Zyrtec did help. Dayquil: Made in (country name), Proctor and Gamble, Strength: acetaminophen 325 mg/ phenylephrine HCL 5mg/ dextromethorphan HBr 10mg, Count: 60 liquid caps, Lot: 9077171961, Expiration date: Dec2021, UPC/NDC unknown. Baby Vicks: Applied on her chest one night, states it did not help and has no product available to provide information. Therapeutic measures were taken as a result of the events headache, sore throat, runny nose, and sneezing. The outcome of the event sore throat was recovered on 01Jun2021; runny nose and sneezing were recovered on 03Jun2021; headache and stuffy nose/ nasal congestion were not recovered; outcome of other events was unknown.

Other Meds:

Current Illness:

ID: 1442619
Sex: F
Age:
State: VA

Vax Date: 06/03/2021
Onset Date:
Rec V Date: 07/02/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: Shingles; This is a spontaneous report from a contactable nurse. A 48-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in the left arm on 03Jun2021 at 09:03 (Batch/Lot Number: EW0180) as 2ND DOSE, SINGLE for COVID-19 immunisation. Medical history included Psoriatic arthritis, Psoriasis and an autoimmune disorder. Concomitant medication included secukinumab (COSENTYX) taken for an unspecified indication, start and stop date were not reported. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in the right arm on 10May2021 at 10:16 (Batch/Lot Number: EW0173) as 1ST DOSE, SINGLE for COVID-19 immunisation, and didn't have reaction with that shot. The patient had no prior vaccination within 4 weeks. The patient called to report that she got her second shot and it's not dangerous like threatening or death or anything like that, but she did come down with shingles after her second vaccination. When probed for permission to probe, the patient added that it was totally fine. She just wanted to make sure she reported it, because she thought it would probably be tracked for people with autoimmune issue. When asked regarding the causality, the nurse (patient) agreed that it is, but there was more to it than just that. She added that she was immunocompromised, she has an autoimmune disorder, and have psoriatic arthritis for which she is treated and at a higher risk for side effect. The nurse added that she did get a confirmation from her primary care doctor. She did guarantee the day before and did confirm it was shingles. Treatment for the adverse effects included some steroid. The patient added that she was on Nitropack (not clarified further) right, and on Acyclovir which has helped tremendously with the side effect. With regards to the lab test, the nurse stated that she didn't need any, they were able to look at it, and they were able to examine her. The blisters were very apparent that it was not psoriasis and that it was shingles because it looks very different from her psoriasis, and it follows the pattern which shingles does. The patient also stated that she just wanted to make sure that they get this information so that they can keep tracking more and more. The outcome of the events was unknown. Information on the batch/lot number has been requested.

Other Meds: COSENTYX

Current Illness:

ID: 1442620
Sex: F
Age:
State: AZ

Vax Date: 06/06/2021
Onset Date: 06/06/2021
Rec V Date: 07/02/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: pretty high temperature; This is a spontaneous report from a contactable consumer (parent). A 19-year-old female patient (daughter) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number was not reported) via an unspecified route of administration, administered in right arm, on 06Jun2021 at 14:00 (at the age of 19 years old) as 1st dose, single for COVID-19 immunisation. Medical history included diabetes and asthma. Concomitant medications included insulin lispro (HUMALOG); and, insulin glargine (LANTUS), both were taken for an unspecified indication, start and stop date were not reported. The patient has no prior vaccination within 4 weeks. On 06Jun2021, about 5 or 6 hours ago, it was reported that the patient experienced pretty high temperature, and they wanted to know if that's an after effect of the shot because it's not listed in the side effects. The treatment for the adverse event was just a rest (as reported). The outcome of the event was unknown. Information about batch/Lot number has been requested.

Other Meds: HUMALOG; LANTUS

Current Illness:

ID: 1442621
Sex: F
Age:
State: IA

Vax Date: 06/04/2021
Onset Date: 06/04/2021
Rec V Date: 07/02/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: During day of 6/7, was able to keep down a little food, but still experiencing nausea; diarrhea; Range of motion in arm was also quite limited; could not engage in normal activities; Nauseated; arm was very sore; bouts of dizziness which continued for next two days; felt very hot; face flushed; This is a spontaneous report from a contactable consumer (patient). A 38-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 04Jun2021 17:45 (Batch/Lot Number: EW0171) age at vaccination of 38-years-old, as single dose, for covid-19 immunisation. Medical history included covid-19 from an unknown date and unknown if ongoing (Prior to vaccination). The patient was not pregnant and was not pregnant at the time of vaccination. Concomitant medications included ascorbic acid (VIT-C) taken for an unspecified indication, start and stop date were not reported; ergocalciferol (VIT D) taken for an unspecified indication, start and stop date were not reported; calcium citrate (CALCIUM CITRATE) taken for an unspecified indication, start and stop date were not reported and multivitamin for an unspecified indication, start and stop date were not reported. The patient previously took trimox ketone and experienced drug hypersensitivity. Immediately after shot, on 04Jun2021 18:00, the patient felt very hot and face flushed; then approximately 1 hour after, had bouts of dizziness which continued for next two days. During the evening of 05Jun2021, became nauseated (and arm was very sore), and most of day during 06Jun2021, had diarrhea and additional nausea, could not engage in normal activities and range of motion in arm was also quite limited. During day of 07Jun2021, was able to keep down a little food, but still experiencing nausea. No treatments were given for the events. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient was recovering from the events.

Other Meds: VIT-C; VIT D; CALCIUM CITRATE

Current Illness:

ID: 1442622
Sex: F
Age:
State: FL

Vax Date: 06/06/2021
Onset Date: 06/07/2021
Rec V Date: 07/02/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: Excessive bleeding in the vaginal area and what looks like skin like shedding/mucus shedding; Excessive bleeding in the vaginal area and what looks like skin like shedding/mucus shedding; This is a spontaneous report from a contactable consumer (patient). A 23-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 06Jun2021 17:00 (Batch/Lot Number: EWO177), age at vaccination of 23-years-old, as single dose,for covid-19 immunisation. Medical history was none. The patient was not pregnant and was not pregnant at the time of vaccination. The patient had no allergy. Concomitant medications included lisdexamfetamine mesilate (VYVANSE) taken for an unspecified indication, start and stop date were not reported; ethinylestradiol, norgestimate (ESTARYLLA) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced excessive bleeding in the vaginal area and what looks like skin like shedding/mucus shedding on 07Jun2021 11:00 AM. No treatments were given for the events. Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store. 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 was not recovered from the events.

Other Meds: VYVANSE; ESTARYLLA.

Current Illness:

ID: 1442623
Sex: F
Age:
State: FL

Vax Date: 06/03/2021
Onset Date: 06/06/2021
Rec V Date: 07/02/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: rash down three quarters of left arm; Arm was hot, very itchy and red; Arm was hot, very itchy and red; Arm was hot, very itchy and red; This is a spontaneous report from a non-contactable consumer (patient) received via a sales representative. A 68-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 intramuscular, administered in arm left on 03Jun2021 (batch/lot number was not reported) as 2ND DOSE, SINGLE for COVID-19 immunization. Medical history included Psoriatic Arthritis. Concomitant medication included infliximab (REMICADE). The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly, on 13May2021 at the age of 68- years in the left arm for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not pregnant at the time of vaccination. On 06Jun2021, the patient experienced rash down three quarters of left arm, arm was hot, very itchy and red. Therapeutic measures were taken as the result of the events which included treatment with Advil and Benadryl. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was not recovered. The events were considered non-serious. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds: REMICADE

Current Illness:

ID: 1442624
Sex: F
Age:
State: TX

Vax Date: 06/02/2021
Onset Date:
Rec V Date: 07/02/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: broke out a rash all over her face/ bad rash on her face under her eye from her ear to ear down her throat/it was burning/it itch; This is a spontaneous report from a contactable consumer (patient) reported that a 75-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0191), via an unspecified route of administration, administered in arm left on 02Jun2021 (at the age of 75-years-old) as 1st dose, single for covid-19 immunization. The patient medical history included allergies, had a UTI and a bad tooth that needs to be pulled. The patient was taking blood pressure pills and stuff, have been taking two antibiotics. On an unspecified date, the patient broke out a rash all over her face. Have really bad rash on her face under her eye from her ear to ear down her throat. It was burning and she have put allergen gel on it and that's seemed to sooth it, because it itch so bad and she took a Benadryl long ago. The outcome of the event was not recovered. Information on lot/batch number was available. Additional information has been requested.

Other Meds:

Current Illness:

ID: 1442625
Sex: F
Age:
State: AL

Vax Date: 06/01/2021
Onset Date: 06/06/2021
Rec V Date: 07/02/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: Small hives around her wrist on the same arm received the vaccine/ hives on my lower abdomen, near my diaphragm, back of my legs, thighs and arms again; Itchiness on both of the arms; Some redness/ getting red on my wrist that I was vaccinated on my left wrist and then on my right arm; I am scratching it my skin and kind of broke out in some slight hives, small little hives and getting red; This is a spontaneous report from a contactable consumer (patient). A 32-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: GW0177), via an unspecified route of administration, administered in left arm on 01Jun2021 16:30 as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient had no prior vaccination within 4 weeks. The vaccination facility type was pharmacy/drug store. One week after getting the vaccine on Sunday (06Jun2021), the patient had some small hives on her wrist (same arm that received the vaccine) and it was itching in both arms. She took some Benadryl and the itching ceased but there was still some redness. The patient had woke up in the middle of the night of 06Jun2021 and she was scratching it her skin and kind of broke out in some slight hives, small little hives and getting red on her wrist that she was vaccinated on her left wrist and then on her right arm she was kind of breaking out and scratching kind of hard. She took a half of a Benadryl cleared it up and then the very next day she ended up breaking out. She had hives again on her left wrist abdomen and the back of her legs. The next day, she had hives on her lower abdomen, near her diaphragm, back of my legs, thighs and arms again. She spoke with her doctor and he said to call Pfizer to report the side effects and wanted to know if she should get the 2nd dose. She is scheduled for the 2nd dose on 22Jun2021. Therapeutic measures were taken as a result of the events and included treatment with Benadryl (formulation not specified). The outcome of the events hives, itching, and vaccination site erythema were recovered on 08Jun2021, and for the event scratch was recovered on Jun2021.

Other Meds:

Current Illness:

ID: 1442626
Sex: F
Age:
State: TX

Vax Date: 04/16/2021
Onset Date: 04/17/2021
Rec V Date: 07/02/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: Chills; Severe headache; Really bad tinnitus; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: ER8731), via an unspecified route of administration, administered in left arm on 16Apr2021 15:00 (at the age of 65 years old) as dose 1, single for COVID-19 immunization. Medical history included mildly high blood pressure, and Sulfa-based drugs allergy from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included acetylsalicylic acid (ASPIRIN 81); hydrochlorothiazide; and losartan, all taken for an unspecified indication. The patient previously took aspartame and experienced drug allergy. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. After vaccination, on 17Apr2021, the patient woke up at 01:30 AM with chills and a severe headache. The symptoms disappeared the next day, but still have mild headaches and noticed really bad tinnitus several days later on an unspecified date in 2021. No treatment was received for the events. The outcome of the event really bad tinnitus was unknown, and for other events was recovered with sequel. The patient received the second dose of BNT162B2 on 07May2021 15:00, for COVID-19 immunization.

Other Meds: ASPIRIN 81; HYDROCHLOROTHIAZIDE; LOSARTAN

Current Illness:

ID: 1442627
Sex: M
Age:
State: CA

Vax Date:
Onset Date:
Rec V Date: 07/02/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: elevated liver enzymes; ALT is in the upper range; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient stated that he was having an adverse reaction that was not listed on "the site" and was not a general reaction. He said that he had a lot of reactions but he was most concerned about his elevated liver enzymes. He had a blood test 3 days after getting the first dose of the Pfizer COVID-19 vaccine and his ALT was in the upper range. He did another blood test 2 months later and his ALT level barely came down. He wanted to know all the information from Pfizer about having an elevated ALT level after vaccination. He talked to his hepatologist, he had an elevated ALT score that they were concerned about and it was remained elevated in the upper range for about 2 months now following the vaccine. He had also had a bunch of other side effects but the most concerning for him was his liver and he thought there was a link because he had done a lot of enzyme test, liver panel over the last 15 years and he had never seen this level of ALT on his liver health before his life and this blood test had taken 3 days after he received first dose of Pfizer vaccine. The outcome of the events was unknown. Information regarding the Lot/Batch number has been requested.

Other Meds:

Current Illness:

ID: 1442628
Sex: F
Age:
State: OR

Vax Date: 05/05/2021
Onset Date: 05/19/2021
Rec V Date: 07/02/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: where RUQ tenderness was noted on exam; BILI was 1.1; C-reactive protein (CRP) 25.8; She had persistent circulation sxs in her feet/ persistent Raynaud's type sxs primarily; her toes felt numb; patient noticed her toes felt numb, looked purplish; patient noticed her toes felt numb, looked purplish, and were cold; fever > 101 with chills and myalgias; fever > 101 with chills and myalgias; fever > 101 with chills and myalgias; This is a spontaneous report from a contactable Physician. A 38-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), at the age of 38-year-old, via intramuscular on 05May2021 as single dose for COVID-19 immunisation. Medical history included morbid obesity, fibromyalgia, Post-traumatic stress disorder (PTSD), Anxiety, Attention deficit hyperactivity disorder (ADD), depression, prehypertensiony. Known allergies: cefixime (FLEXERIL), tape. The patient previously received the first dose of BNT162B2 on 14Apr2021 at the age of 38-year-old, for COVID-19 immunization. Concomitant medications included bifidobacterium infantis (ALIGN); ergocalciferol (VIT D); iron; magnesium. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Clinical course: On 19May2021 the patient noticed her toes felt numb, looked purplish, and were cold. She took a shower, then spiked a fever > 101 with chills and myalgias. 48 hours later her fever was improved and she went for a COVID test (on 21May2021), which was negative. She had persistent circulation sxs in her feet. The reporter saw her on office on 25May2021, where RUQ tenderness was noted on exam. Labs were significant for white blood count (WBC) 8.0 with normal difference, Blood albumin (ALB) 3.3, Blood bilirubin (BILI) 0.3, C-reactive protein (CRP) 25.8, Red blood cell sedimentation rate (ESR) 54, normal Urine analysis (UA), Antinuclear antibody (ANA) 1:80 with a cytoplasmic pattern, neg cascade. Ultrasound abdomen (Abd U/S) was negative. Repeat labs 03Jun2021 her CRP was now 9.3 and BILI was 1.1, otherwise negative CBC and CMP. Patient seen 08Jun2021 with persistent Raynaud's type sxs primarily. Repeat labs pending at the time of this report. The events were reported as non-serious. No treatment received for the events. The events resulted in physician office visit. The outcome of the events was recovering. Information on the lot/batch number has been requested.

Other Meds: ALIGN; VIT D; IRON; MAGNESIUM.

Current Illness:

ID: 1442629
Sex: F
Age:
State: AZ

Vax Date: 06/04/2021
Onset Date: 06/07/2021
Rec V Date: 07/02/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: Rapid Heart Beat; chest pain; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, LOT/Batch number and expiration date unknown) via an unspecified route of administration in right arm on 04Jun2021 at 16:00 at age of 40-year-old at single dose for COVID-19 immunization. Patient was not pregnant at time of vaccination and events onset. Relevant medical history was none. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient didn't receive any other medications within 2 weeks of vaccination. On 07Jun2021 at 02:00 AM, patient experienced rapid heart beat and chest pain. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care visit. Outcome of the events was not recovered. No treatment received for the events. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1442630
Sex: F
Age:
State: NE

Vax Date: 03/19/2021
Onset Date: 05/29/2021
Rec V Date: 07/02/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: Broke out with shingles; This is a Spontaneous report from a Pfizer sponsored program Accredo Xeljanz Program. A Contactable Nurse reported for a 62-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on an unspecified date (age at vaccination: 62 year), as a single dose for COVID-19 immunization and tofacitinib citrate (XELJANZ XR, prolonged-release tablet), via Oral, from 19Mar2021 (Batch/Lot number was not reported; Expiration Date: 28Feb2023) to an unspecified date, at 11 mg, daily for rheumatoid arthritis. It was unknown if the patient was pregnant at the time of vaccination. The patient's medical history included allergies: codeine. Concomitant medications included urea, methotrexate, valaciclovir hydrochloride, hydroxychloroquine sulfate, duloxetine HCL, pregabalin, and methylprednisolone. The patient held her doses of xeljanz prior to receiving her second COVID-19 vaccinations. It was reported that on 29May2021, the patient was broke out with shingles. Outcome of the event was not resolved. Please provide the Information of lot/batch number of suspect product.

Other Meds: UREA; METHOTREXATE; VALACYCLOVIR [VALACICLOVIR HYDROCHLORIDE]; HYDROXYCHLOROQUINE SULFATE; DULOXETINE HCL; PREGABALIN; METHYLPREDNISOLONE

Current Illness:

ID: 1442631
Sex: F
Age:
State:

Vax Date: 05/19/2021
Onset Date: 05/01/2021
Rec V Date: 07/02/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: developed chills; achiness; headache; crawling sensation in her throat; This is a spontaneous report from a contactable nurse (patient). A 62-year-old female patient received the first dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 19May2021 (received at the age of 62-years-old) as DOSE 1, SINGLE for COVID-19 immunization. Medical history included immune compromised from an unspecified date and ongoing. Concomitant medications were not reported. The patient experienced chills, achiness, headache, crawling sensation in her throat on May2021. The patient received her first Pfizer Covid vaccine dose on 19May2021. After which she developed chills, achiness, and a headache. She states that later that same day she had "a crawling sensation" in her throat. She was apprehensive about getting the second dose and was advised by an HCP to take Benadryl before the second dose of the vaccine on 08Jun2021. Therapeutic measures were taken as a result the adverse events. Outcome of the events was unknown. Information on batch number has been requested.

Other Meds:

Current Illness: Immune disorder (NOS)

ID: 1442632
Sex: F
Age:
State: WA

Vax Date:
Onset Date:
Rec V Date: 07/02/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: having dreams about dead people following the second dose of the Covid-19 vaccine; This is a spontaneous report received from a contactable other healthcare professional (nurse). This nurse reported similar event for two patients. This is the second of two reports. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 from an unspecified date for COVID-19 immunisation. The nurse reported that she was not the only one having nightmares. Nurse reported that her coworker, the patient, had the PFIZER-BIONTECH COVID-19 VACCINE and said that she had the same problem. Nurse stated that her coworker reported that she was having dreams about dead people following the second dose of the COVID-19 vaccine. The nurse reported that the patient was better now but that the patient said she thought she was going to die. The outcome of the event was recovering. Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021677871 same reporter/drug/event, different patient

Other Meds:

Current Illness:

ID: 1442633
Sex: F
Age:
State: PA

Vax Date: 05/10/2021
Onset Date: 05/01/2021
Rec V Date: 07/02/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: Hives on left wrist; started feeling a little funny when she first got the vaccine; Felt really tired; Raspy voice; This is a spontaneous case from a female contactable consumer (patient herself). A 61-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- ER8736) via an unspecified route of administration in left arm on 10May2021 as dose 1, single (at the age of 61-years-old) and received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EW0173) via an unspecified route of administration in left arm on 07Jun2021 as dose 2, single for COVID-19 immunization. Vaccine was not administered at Military Facility. Patient history included ongoing seasonal allergies, hypertension, benign tumor in breast (found at 16 years old), type II diabetes from 2014, thyroid, non-smoker, fibroid tumor (surgically removed in 2003), anemia, overweight (but was losing weight) parasites, hay fever. In early 2000s, her glucose was 80 which was normal. UTI infections for which patient took ciprofloxacin in the past. Patient experienced typical dizziness from the Ciprofloxacin. Patient was allergic to trees, foods and cats, dust and grass that is freshly cut, beef, corn, strawberries, ragweed and blooming flowers/plants. Her allergies have tremendously improved the older she has gotten. In the 1990s, they were really bad. She was eating scallops and other seafood. She knows she was getting contaminated food. She picked up these parasites which eat the glucose and other nutrients out of her body. She went from one doctor to another, only 2 doctors found the parasites. These parasites are microscopic and some of them could be pinworms, but also could look like hookworms, pinworms, and different types of parasites. She believed she developed Type II Diabetes because the parasites were eating glucose and nutrients out of her body. She was previously eating well, three meals a day. She confirms she was diagnosed for diabetes in 2014. She was severely anemic in 2003. She knows if the anemia goes on for 6 months, she can have vital organ failure. She had not been tested lately for anemia. Patient family history included patient said her brother was allergic to the penicillin family. Her brother had Covid. He tested seventh in the county for Covid last year. He also took the vaccine this year. The concomitant medications were not reported. The patient stated when she first got the vaccine, she started feeling a little funny. She broke out in hives on her wrists about an hour after both injections. She clarified that the hives were only on the wrist of the arm where she got the vaccine. When she tried to tell people she broke out in hives immediately within an hour after receiving the vaccine, people were doubting her. She makes the comment that we all have a different chemical make-up and she is allergic to a lot of things. She did have a reaction. The reactions that she mostly had were that she got tired and she did get hives around her wrist. She comments that she has had hives around her wrist before, but mostly it had been a reaction to food that she was allergic to. She had been tested by allergists with standard tests. She explained they used to do injections and now they do the back test. She had broken out in hives around her wrist before, this was not the first time. She had 3 other health conditions that gets her attention. Patient was not sure if the stress and the spike in her blood pressure could have anything to do with the hive breakout or if it was an anaphylactic reaction. When she came down with the second tumor, she became severely anemic and she gained 100 pounds. She clarifies the tumor was the size of a golf ball, 3.5cm fibroid. She became severely anemic and had a hemoglobin count of 7.6. She told to the healthcare team she suspected a tumor. Instead of listening to her, she was tested for diabetes and other things, and were not on the right track. Those tests were coming back negative. So, she did gain a lot of weight and she is taking the weight off, but it had took a long time. Her underlying conditions could have led to her death, and her doctors did not get her to any other professionals. The hives on her wrist started again a day before (07Jun2021), but she actually broke out in hives the first time after the first injection. Patient stated the first dose was in the beginning of May, about 3 or 4 weeks ago. She later confirmed the first dose was on 10May2021. She confirmed she broke out in hives the same day she received her doses, within the hour. She confirmed the hives were on her wrist of her left arm, where she had the injection. She confirms there were no hives on the right wrist. The hives were still ongoing today, but they were going down. She can still see the hives and feel the bumps under her skin. However, they looked like they were going down. She has had hives before so she knows what they were. Patient stated she felt really tired and she woke up in hives. She had a little bit of a raspy throat. Her throat did not hurt, but her voice was a little bit raspy a day before (May2021). However, she also had seasonal allergies. Her allergies were bad in April and May and also bad in September and October. So, one part could be the allergies. However, she thought it was strange she broke out on the same arm where she had the injection. The adverse events did not result in physician office or emergency room visit. Patient did not receive any treatment for the adverse events. The outcome of the event hives was not resolved while of the other events was unknown. Information on Lot/Batch number was available. Additional information has been requested.

Other Meds:

Current Illness: Seasonal allergy (Hay fever, From all of the pollen.); Type 2 diabetes mellitus (She confirms she was diagnosed for diabetes in 2014.)

ID: 1442634
Sex: M
Age:
State:

Vax Date: 01/30/2020
Onset Date:
Rec V Date: 07/02/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: arm was stiff; This is a spontaneous report from a contactable consumer and other healthcare professional. A 70-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 was not reported) as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunisation; ruxolitinib phosphate (JAKAFI), oral from 30Jan2020 (Batch/Lot Number: 1232358; Expiration Date: 28Feb2023) to an unspecified date, at 5 mg, 2x/day for chronic myeloproliferative disease. The patient medical history and concomitant medications were not reported. Ruxolitinib phosphate was used off-label for chronic myeloproliferative disease. Patient's arm was stiff on an unspecified date. Relevant test included on date unknown: routine EKG on tread mill (unknown results), Stress test by cardiologist visit with no problems (normal). The action taken in response to the events for ruxolitinib phosphate was unknown. The outcome of event was unknown. Information about Lot /Batch number has been requested.

Other Meds:

Current Illness:

ID: 1442635
Sex: F
Age:
State: OH

Vax Date: 04/03/2021
Onset Date: 04/03/2021
Rec V Date: 07/02/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: itching all over and breaking out into hives. Arms, legs, back, neck, face; itching all over and breaking out into hives. Arms, legs, back, neck, face; This is a spontaneous report from a contactable consumer (patient). A 20-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in left arm on 03Apr2021 11:00 (at the age of 20-year-old) (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. The patient had no medical history and no concomitant medications. The patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and did not receive other medications within 2 weeks of vaccination. On 03Apr2021, 23:00, about 12 hours after the shot, the patient started itching all over and breaking out into hives in her arms, legs, back, neck, and face. She applied diphenhydramine (BENADRYL) cream which helped somewhat. By the morning, it was gone. When she went to get the 2nd vaccine, they wouldn't give it to her because of the reaction she had and said that the 2nd could give a worse reaction. She stated that she will play soccer in college and was required to get a full vaccine prior to returning to school in August, so she needs to know what she can/should do. Prior to vaccination, the patient was not diagnosed with COVID-19 and Since the vaccination, the patient had not been tested for COVID-19. Outcome of events was recovered in Apr2021. Information about batch/Lot number has been requested.

Other Meds:

Current Illness:

ID: 1442636
Sex: F
Age:
State: NC

Vax Date: 04/01/2021
Onset Date: 04/01/2021
Rec V Date: 07/02/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: The first vaccine, I experienced chills in the early evening first, then fever overnight. Was lethargic for approx. a week.; The first vaccine, I experienced chills in the early evening first, then fever overnight. Was lethargic for approx. a week.; The first vaccine, I experienced chills in the early evening first, then fever overnight. Was lethargic for approx. a week.; This is a spontaneous report from a contactable consumer (patient). A 51-year-old non-pregnant female patient received bnt162b2 (Pfizer/BionTech COVID 19 brand), dose 1 via an unspecified route of administration, administered in left arm on 01Apr2021 16:00 (Lot Number: ER8734) as single for COVID-19 immunization. Medical history included allergies, obesity, and exercise-induced asthma (diagnosed) from an unknown date and unknown if ongoing. Concomitant medications included naproxen sodium (ALEVE) taken for an unspecified indication, start and stop date were not reported; chlorpheniramine maleate taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took codeine and experienced sensitive to codeine product. After the first vaccine on 01Apr2021, patient experienced chills in the early evening first, then fever overnight on 01Apr2021. The patient was lethargic for approx. a week from Apr2021. Outcome of events was recovered in Apr2021. Events was reported as non-serious. The patient has received 2nd dose (lot # ER8736) on 29Apr2021 18:00 in the left arm. Follow-up attempts are needed. Further information is requested.

Other Meds: ALEVE; CHLORPHENIRAMINE MALEATE

Current Illness:

ID: 1442637
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 07/02/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: After the first dose all he had was a sore arm; This is a spontaneous report from a contactable consumer (patient himself) via Medical Information Team. A 25-year-old male patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration as 1st dose, single (at the age of 25-years-old) and received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration in left arm on 07Jun2021 as 2nd dose, single for COVID-19 immunization. Patient medical history and concomitant medications were not reported. After the first dose all patient had was a sore arm. The outcome of the event was unknown. Information about lot/batch number is requested.

Other Meds:

Current Illness:

ID: 1442638
Sex: M
Age:
State: VA

Vax Date: 06/03/2021
Onset Date: 06/09/2021
Rec V Date: 07/02/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: Severe chills, headache, nausea, vomiting for approximately 1-1/2 hours; severe chills, headache, nausea, vomiting for approximately 1-1/2 hours; severe chills, headache, nausea, vomiting for approximately 1-1/2 hours; severe chills, headache, nausea, vomiting for approximately 1-1/2 hours; This is a spontaneous report from a contactable consumer (patient). A 14-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 03Jun2021 16:30 (Lot Number: ew0186) at 14 years old as single dose for covid-19 immunisation. Medical history was none. No Known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received first dose of bnt162b2 on 13May2021 16:30 (lot number: ew0186) at 14 years old in left arm for covid-19 immunisation. The patient experienced severe chills, headache, nausea, vomiting for approximately 1-1/2 hours on 09Jun2021 23:00. Treatment received for the adverse event was aleve pm. Since the vaccination, the patient has not been tested for COVID-19. The outcome was recovered. This case was reported as not serious. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1442639
Sex: F
Age:
State: NY

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

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: could not stand on her feet.; severe dizziness; the dizziness was so bad that she could not walk short distances inside the house (from the kitchen to the bedroom); This is a spontaneous report from contactable consumers (one is patient's husband). A 73-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 07May2021 (Lot Number: EW0167) at 73 years old as single dose for covid-19 immunisation. Medical history included thyroid, glaucoma, heart, blood pressure and vertigo. Concomitant medication(s) included ongoing amlodipine besilate taken for Blood pressure; ongoing levothyroxine sodium taken for thyroid; ongoing atenolol taken for heart; ongoing latanoprost taken for glaucoma. The patient previously took flu vaccine over 20 years ago and she got like hot, like hitting herself, like her head was burning; took the pneumococcal vaccine, maybe 3-4 years ago. 2 days after (8May2021) the patient received the vaccination she started to feel severe dizziness, the dizziness was so bad that she could not walk short distances inside the house (from the kitchen to the bedroom). Patient stated this began on 08May2021 around nighttime, says it was not too much. The following day was really crazy, said she never felt anything like this before. She has had vertigo, but never this kind of dizziness, she experienced this for two or two-and-a-half days. It started about day-and a-half after the vaccine for two days. Patient stated the dizziness was gone, but may have lasting effects, she was not sure. What she went through those two days, she thought she was dying and could not stand on her feet. No emergency room or physician office visit. The patient had to see the doctor for a year because of her thyroid, he made her take a blood test to see if the thyroid was working properly. The outcome was unknown.

Other Meds: AMLODIPINE BESILATE; LEVOTHYROXINE SODIUM; ATENOLOL; LATANOPROST

Current Illness:

ID: 1442640
Sex: F
Age:
State: TN

Vax Date: 06/09/2021
Onset Date: 06/01/2021
Rec V Date: 07/02/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: Burning in toes and feet; eyelids were dry.; burning in my eyes and feet/felt both eyes started to burn.; burning in my eyes and feet; it is persisting and worsened.; This is Spontaneous report received from a contactable consumer (patient). A 52-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0171), via an unspecified route of administration, administered in Arm Left on 09Jun2021 between 14:00 and 15:00 (at the age of 52-years-old), as 2nd dose, single for COVID-19 immunization. Medical history and concomitant medications were not reported. Prior Vaccinations within 4 weeks was None. Historical vaccination included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/lot number: EW0185) via unspecified route of administration in the left arm, on 19May2021 in a daytime 15:00 or 16:00, as 1st dose, single for COVID-19 Immunization and experienced little weak. On 09Jun2021 (day of vaccination), after the needle was out of her arm, the patient experienced burning in her both eyes and feet, especially her left foot and it was still present. On 10Jun2021, the patient experienced burning in toes and feet, eyelids were dry. Caller stated that she did not even feel the needle go in her arm. It was reported that the patient took Pfizer BioNTech Covid-19 Vaccine because lots of people died without it and she figured that she needed to get it. Caller stated that she hadn't weighed herself in a while but she thought she would be about 230 pounds. Caller thought this would last only a little while. She got afraid since it kept going. She read up that toxins can cause burning like that. She wasn't sure what was in the syringe and had her questioning what was in the syringe. It started right after the shot. It burned the rest of the day and into the night. Caller said she woke up last night and it was still burning. This morning it felt like her eyelids were dry. She didn't feel burning as much. They were just dry. It improved but her eyelids were dry. She said the burning in her eyes was a 10 yesterday but a 1 now. Caller stated that her toes were burning especially the left. It moved down from the top to the bottom of the foot. It started this morning. Caller looked on the website for side effects and this was not on the list for side effects. The burning started with the toes and spread to the middle of feet, especially left foot. She was drinking water to try and get the toxins that were in there out. She did not know what would cause this as it was not on the list of side effects. It spread form the toes to the foot. Caller said the right toes were burning but not as bad as the left. Caller stated that she did not do anything but drink water to try and get the toxins out. She went online and say there were toxins in the vaccine and she was wondering about the toxins and what was in the syringe, or if it was outdated. The outcome of the events burning in my eyes and feet/felt both eyes started to burn, burning in toes and feet were not recovered. The outcome of the events eyelid skin dryness and condition aggravated was unknown. Information on Lot/Batch number was available. Additional information has been requested. Follow-up (11Jun2021): This is a follow up spontaneous report from a PPD Pfizer. This PPD Pfizer reported in response via mail follow-up activity which included that: After listening to the call recording associated with the caller confirmed the spelling of her first name. Additional information has been requested; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021683896 same patient/drug, different dose/event

Other Meds:

Current Illness:

ID: 1442641
Sex: F
Age:
State: FL

Vax Date: 03/26/2021
Onset Date: 03/26/2021
Rec V Date: 07/02/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: The ringing in my ear is just depressing me.; Nausea; Has trouble sleeping/she is not sleeping well; Feel weird; Headaches; Gained weight; Felt extremely fatigued; Arm was a little sore; Neck pain around the right side; Tinnitus; This is a spontaneous report from a contactable consumer.A 74-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 26Mar2021 (Batch/Lot Number: ER2613) as 2ND DOSE, SINGLE DOSE for covid-19 immunisation. She has had adrenal insufficiency and took steroids for that for quite some time. On Nov2018 she weened off of steroids after being on them for a long time, and her adrenals kicked in. She has been totally off of steroids since then. Every 6 months she gets her cortisol and ACTH tested which is related to the adrenals, and everything is perfect. Her adrenal insufficiency was probably stress related. Her husband, the woman that raised her, and her dog all died within a year in 2002 or 2003, plus she was holding down and job and flying back and forth taking care of her aunt. They thought she had it for longer than she had symptoms. It started in 2004 or 2005. There were no concomitant medications. Patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE,lot: EN6199) on 03Mar2021 in her left arm for covid-19 immunization and experienced tinnitus.She developed tinnitus after receiving the vaccine. She feels nausea and has trouble sleeping because of that. They are all complaining of ringing in the ear. It is just not Pfizer but Moderna vaccine as well.she received the injection in the left arm. she developed a neck pain around the right side. The neck pain started around the same time as I received my vaccine. she feel nauseous. She just feel weird when she get up. It is quite bothersome and affecting my life. She would be incredible difficult to live like this. She feel out of center. The ringing in her ear is just depressing me. She can not believe something like this could happened to her. The intensity is not minimal. She was trying to have an optimist view she thought it will go away but it did not. She felt extremely fatigued on 27Mar2021 with outcome of recovering, arm was a little sore on 26Mar2021 with outcome of unknown , gained weight on an unspecified date with outcome of unknown. She is fairly new to her area. She had an appointment with her physician yesterday, and she did ask if there were any complaints of tinnitus. Her physician answered in the negative, but she had received a complaint of rectal bleeding. She told her physician that her tinnitus was really bothering her. Her physician looked in her ears, nose, and throat, and it did not seem to be allergy related. She was hoping it would be allergies so she could take Allegra and it would go away. She has no email available for her physician. When she lived in (withheld) all of the doctors were in contact through email. Here it seems it is just phone and fax for everything.Second dose Extremely fatigued: She had no other side effects except for the second day after the second dose she felt extremely fatigued and that was it. The second day she noticed the fatigue was more pronounced. Second dose Terrible Tinnitus: Now it is into June, and she wanted to wait until she was sure there was something really going on. She was taking Benadryl, but all it did was make her sleepy. Her sister in law told her to try one of the allergy medications, she can not remember what it was. She only took it once or twice and it did not do anything. It said on the allergy medication package that it relieves symptoms within 24 hours, but it was 48 hours and she had no relief. She does not take the Benadryl any longer. Benadryl lot: LAL0002, expiration date: Dec2022.Second dose Extremely fatigued: Then she woke up and her ears were ringing and she was tired. She thought what is going on here. She slept on and off that Saturday which would have been 27Mar2021 and then it just continued. Every now and then she still feels fatigued. It is pretty typical for her, she is not exercising like she should. The patient underwent lab tests and procedures which included blood corticotrophin: everything is perfect on Every 6 months she gets her cortisol and ACTH tested which is related to the adrenals, and everything is perfect. Therapeutic measures as Benadryl were taken as a result of tinnitus .Outcome of Felt extremely fatigued was recovering, outcome of Tinnitus was not recovered, for remaining events was unknown.

Other Meds:

Current Illness:

ID: 1442642
Sex: F
Age:
State:

Vax Date: 04/08/2021
Onset Date: 04/01/2021
Rec V Date: 07/02/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: she had first dose of Pfizer on 08Apr2021 and first dose of Moderna on 18May2021; Caller had the first dose of the Pfizer COVID-19 vaccine on 08Apr2021 tested positive for COVID-19 on 18Apr2021.; I got sick; went to a physician with severe symptoms; Physician told her she needed to start over with the Vaccine with first and second dose; This is a spontaneous report from a contactable consumer(patient). A female patient of an unspecified age received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 08Apr2021 as, 1st dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Consumer stated that she received the Pfizer vaccine the first dose on 08Apr2021 then came down with COVID on 10Apr2021, just two days later, went to a physician with severe symptoms on 18Apr2021 and he diagnosed me Positive and he told me that since she had the Pfizer Vaccine just before I got sick I was going to have to start over another first dose and then a second dose, so not knowing you know there may be any difference she received first dose of Moderna on 18May so, she had first dose of Pfizer on 08Apr2021 and first dose of Moderna on 18May2021 and she don't know since the first dose of Pfizer was a long ago and she asked do I go ahead with the second dose of Pfizer or do I go ahead with the Moderna since I got it on 18May2021 and get the second dose of Moderna. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 18Apr2021. Reporter seriousness for Had her first dose of Pfizer COVID-19 Vaccine on 08Apr2021 and came down with COVID on 10Apr2021, 2 days after: Unspecified. The outcome of the events was unknown. Follow up (10Jun2021): This is a Follow up spontaneous report from a contactable consumer. This consumer (patient) reported that: event details. Information about lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1442643
Sex: F
Age:
State: MD

Vax Date: 05/19/2021
Onset Date:
Rec V Date: 07/02/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: hives; rash; itching; This is a spontaneous report from a contactable consumer reported for herself. This 63-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Left Arm on 19May2021 10:30 (Lot Number: EW0182) at single dose for COVID-19 immunisation. Medical history included Hypothyroid, allergies. The patient's concomitant medications were not reported. Patient was not pregnant. The patient experienced hives, rash, itching on unspecified date with outcome of recovering - did not relate to vaccine at the time. Events resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. AE Treatment: Steroid, diphenhydramine hydrochloride (BENADRYL) and famotidine (PEPCID). Patient did not have COVID prior vaccination, and did not have COVID tested post vaccination.

Other Meds:

Current Illness:

ID: 1442644
Sex: F
Age:
State: GA

Vax Date: 03/02/2021
Onset Date: 03/25/2021
Rec V Date: 07/02/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: Has happened for 3 months now on both arms; fall asleep; pins and needles sensation/ tingling in my feet; This is a spontaneous report from a contactable consumer. A 37-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 02Mar2021 13:15 (Lot Number: EL9264) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included migraine (hormone triggered). Concomitant medications included diclofenac potassium (CAMBIA); rizatriptan benzoate (MAXALT) taken for an unspecified indication, start and stop date were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced has happened for 3 months now on both arms, fall asleep, pins and needles sensation, tingling in my feet on 25Mar2021 22:00. Clinical course reported as: If I lay on my side the arm will fall asleep and pins and needles sensation will continue for hours even after no longer laying on the side. Has happened for 3 months now on both arms. Also tingling in my feet. Outcome of events was not recovered. Treatment included Gabapentin not working. The patient underwent lab tests and procedures which included nerve study: normal. events resulted Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Since the vaccination, the patient has not been tested for COVID-19.

Other Meds: CAMBIA; MAXALT

Current Illness:

ID: 1442645
Sex: M
Age:
State: IL

Vax Date: 03/11/2021
Onset Date: 03/12/2021
Rec V Date: 07/02/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: Shortness of breath; Chest pain; rapid respiration; weakness; increased heart rate; This is a spontaneous report from a contactable consumer (patient). A 60-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EN6199), via an unspecified route of administration, administered in Arm Left on 11Mar2021 09:00 (at age of 60 years old) as single dose for COVID-19 immunization. Medical history included Kidney stone. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient's concomitant medications were not reported. The patient had Chest pain, shortness of breath, rapid respiration, weakness, increased heart rate on 12Mar2021 12:00PM. The adverse event result in: Emergency room/department or urgent care. No treatment received. The outcome of the events was unknown. This case Serious reported as No.

Other Meds:

Current Illness:

ID: 1442646
Sex: F
Age:
State: CT

Vax Date: 04/07/2021
Onset Date: 04/07/2021
Rec V Date: 07/02/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: Felt immediate tiredness after injection; Debilitating symptoms; Developed body pain; Swelling in joints; Inflammation; This is a spontaneous report from a contactable consumer (patient). This 73-year-old female non-pregnant patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via unspecified route of administration in left arm on 07Apr2021 at 14:15, at patient age of 73-year-old, as single dose (Lot number ER8737) for COVID-19 immunization. The patient was not diagnosed with COVID-19 prior to vaccination. The patient's medical history included asthma, pituitary surgery, spinal surgery, knee replacement. The patient's concomitant medications included fluticasone propionate, salmeterol xinafoate (ADVAIR), lorazepam, salbutamol (ALBUTEROL), ibuprofen (ADVIL). The patient's relevant past drug history included penicillin and sulfa drugs. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via unspecified route of administration in left arm on 17Mar2021 at 14:00, at patient age of 73-year-old, as single dose (Lot number EN6208) for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received the second dose of bnt162b2 on 07Apr2021. On 07Apr2021, the patient felt immediate tiredness after injection with debilitating symptoms continuing for 7 weeks, under the care. Finally, she developed body pain and swelling in joints. The patient was examined by doctor and gave blood sample on 24May2021. Blood work showed inflammation, causing pain and swelling. Initially prescribed hydroxychloroquine and gabapentin; added prednisone which started on 10Jun2021. The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was not resolved.

Other Meds: ADVAIR; LORAZEPAM; ALBUTEROL [SALBUTAMOL]; ADVIL [IBUPROFEN]

Current Illness:

ID: 1442647
Sex: F
Age:
State: OH

Vax Date: 05/14/2021
Onset Date: 05/15/2021
Rec V Date: 07/02/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: Heart palpitation of 122 hps that lasted 12 hours; Fatigue; short of breath; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received the second dose of BNT162B2 (PFIZER COVID-19 VACCINE, lot number: unknown), at the age of 46 years old, in left arm on 14May2021 11:30 at single dose for COVID-19 immunisation. The patient medical history was none. The patient was not pregnant. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks and any other medications within 2 weeks prior to vaccination. The patient previously took hydrocodone bitartrate and acetaminophen (VICODIN) and eritromicina (reported as erithromicine) and experienced allergies. The patient previously received the first dose of BNT162B2 (lot number: unknown), at the age of 46 years old, in left arm on 23Apr2021 11:30 at single dose for COVID-19 immunisation. The patient experienced heart palpitation of 122 hps that lasted 12 hours, fatigue and short of breath on 15May2021 02:00. The patient had not been tested for COVID-19 since the vaccination. No treatment received. The outcome of events was recovered. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1442648
Sex: M
Age:
State: FL

Vax Date: 03/28/2021
Onset Date: 04/20/2021
Rec V Date: 07/02/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: difficulty breathing and shortness of breath.; fever; chills; lethargy; This is a spontaneous report from a contactable consumer. A 21-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 28Mar2021 (Lot Number: ER8734) at age of 20 years old as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was not reported. Prior to vaccination the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient previously received first dose of bnt162b2 (lot number: EP7534) at age of 20 years old on 28Mar2021 for COVID-19 Immunisation and experienced fever, chills, lethargy. The patient experienced difficulty breathing and shortness of breath, fever, chills, lethargy on 20Apr2021 12:00. No treatment was received. Clinical course reported as: The night of the second dose, I began to have difficulty breathing and shortness of breath. This slowly became worse the next day. The breathing issues did subside over about two weeks and now I am 95% back to normal. I did experience fever, chills, and lethargy for both of the second doses. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 22Apr2021 Nasal Swab, sars-cov-2 test: negative on 25Apr2021 Nasal Swab, sars-cov-2 test: negative on 26May2021 Nasal Swab. Outcome of events was recovering. Since the vaccination the patient had not been tested for COVID-19. Case was reported as nonserious.

Other Meds:

Current Illness:

ID: 1442649
Sex: F
Age:
State: MI

Vax Date: 06/01/2021
Onset Date: 06/01/2021
Rec V Date: 07/02/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: Her body produces mucous/blowing her nose; She had a horrible cough she couldn't get out; her blood clot was already high; lose her voice; She had chills; rattle in her chest; She was cold ,and it was hot (88 degrees); She was sweating, and was warm all over her body.; She was sweating, and was warm all over her body.; Her throat seemed sore after.; She had dry cough. It felt dry; This is a spontaneous report from a contactable consumer (Patient) via Medical Information Team. A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EW0183, NDC number and Expiry date: Unknown), via an unspecified route of administration, administered in left arm on 01Jun2021 (at the age of 48-years-old) as dose 1, single for COVID-19 immunisation. Medical history included ongoing high WBC/white blood cell count increased and anaemic. Patient was overweight. Patient said that before the shot, she as been exposed to COVID-19 and never caught the virus. She has taken a COVID-19 test and it was negative two days ago and does not have COVID. Concomitant medication(s) included fenofibrate taken for blood cholesterol, colecalciferol (VITAMIN D 2000), iron, losartan and hydrochlorothiazide taken for blood pressure, from an unspecified start date and ongoing. It was reported that, two days after getting vaccinated, the patient got sick, and she feels like she has pneumonia. She was overweight. On an unspecified date in Jun2021, her body produces mucous/blowing her nose, and she had chills on 03Jun2021. Patient said that it all started a little after the shot. She felt like she had sand in her throat and she woke up feeling bad. She had a horrible cough on an unspecified date she could not get out. She still has a rattling in her chest. She wants to know if it is possible for this to stay in her chest and form a blood clot. Patient said that after vaccination, she had her nephew graduation, and she screamed at it. Then her throat seemed sore after and she would lose her voice, but it would come back. Her throat started hurting. As the days went on, she felt like there was dust in her throat. She had dry cough and it felt dry. It was like more dust had collected in her throat. Patient felt real sick, but she never had a fever. She was cold and it was hot (88 degrees) in and was sweating and was warm all over her body. Patient has a higher than normal WBC/ and that was one of her main concerns about getting the vaccine. Since her blood clot was already high and she was scared it would put her WBC in maximum overdrive. There was no investigation assessment. The patient underwent lab tests and procedures which included coagulation test: high on unspecified date in 2021 her blood clot was already high, SARS-CoV-2 test: Negative on 30May2021 and white blood cell count: high on unspecified date in 2021 (high white blood cell count). Patient wanted to know if there is any chance of getting pneumonia with the vaccine for which patient received response as "a review of the Prescribing Information for Pfizer COVID-19 vaccine failed to find any information regarding pneumonia being an adverse event with the vaccine". Patient was wondering if Pfizer is getting reports of side effects being full on pneumonia like symptoms that last. Patient asked if there was any chance that of blood clots after vaccination, and would like to know if anemic people who had the vaccine had adverse events and if there had been reports of cytokine storm and received response which says, failed to find any information regarding cytokine storm being an adverse event with the vaccine and was asked patient to consult with her doctor or health care provider for further guidance. The outcome of the events rattle in her chest, her throat seemed sore after, she had dry cough and her blood clot was already high was not recovered, and the outcome of chills, she got sick, her body produces mucous/blowing her nose, she had a horrible cough she couldn't get out, she was cold, and it was hot (88 degrees), she was sweating, and was warm all over her body and lose her voice was unknown. Information on Lot/Batch number was available. Additional information has been requested.

Other Meds: FENOFIBRATE; VITAMIN D 2000; IRON; LOSARTAN; HYDROCHLOROTHIAZIDE

Current Illness: WBC increased (she has a high white blood cell count and is anemic.)

ID: 1442650
Sex: F
Age:
State:

Vax Date: 06/08/2021
Onset Date: 06/08/2021
Rec V Date: 07/02/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: Fell on the floor and could not get herself up; Felt a shock; Puking and throwing up; Headache; Dizziness and could not get self up; Feeling like throwing up; Tightening of the lips; stomach was so painful; Unable to eat; Feeling so weak; Fever; Feeling so tired; Lost a lot of weight; She could not do anything; GI issues like feeling like things in her stomach and not feeling comfortable at all.; She was out of breath from the puking.; Not constipation but a sharp pain.; She does fasting and does not have an appetite; This is a spontaneous report from Other HCP (Nurse assistant; patient herself). A 39-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EW0186; Expiration Date: 31Aug2021) via an unspecified route of administration, administered in Arm Left on 08Jun2021 as single dose for COVID-19 immunization. Medical history included vitamin D from an unknown date and unknown if ongoing she used to take Vitamin D, accident from 2020 to an unknown date She states there was one time she had an accident and took a baby aspirin. History: Caller used to take supplement but not she did not, she used to take Vitamin D which was a supplement she takes every day like a Vitamin D and a women's pill and she used to take a fish pill but since this time she was not taking anything because she did not want anything that would be contraindication. Caller did not clarify statement or provide any additional details. She states there was one time she had an accident and took a baby aspirin but she did not take it anymore. Caller confirmed she was not taking these at time of vaccination and that her accident occurred prior to the vaccine. Caller added she was not allergic to anything, she had never reported an allergic reaction, and any medication she did not have anything she feels she was allergic to. She was good. Her health was good. Patient had not any other history and products. The patient's concomitant medications were not reported. It was reported that, she received her first injection on 08Jun2021 and she felt like that night and the whole day she threw up, had some puking and stomach, heavy headache, and a lot of dizziness. She called back her husband and her husband called back because she could not do anything. She had a headache, dizziness, fell on the floor and could not get herself up. Caller added that she started feeling like throwing up and her lips would tighten up and her stomach was so painful she has not been able to eat and has been throwing up which is a problem. Right now, she had one week without eating well. She feels like she have to go to the bathroom or like her stomach was upset and she has to throw up instead of having a BM. She had a headache and was feeling so tired and like a headache. She decided to call to see if Pfizer had experienced something like this because of how her stomach was acting. Caller was asked for clarification as she was speaking fast and states she was having GI issues like feeling like things in her stomach and not feeling comfortable at all. Caller stated that night they called 911 because it was serious and was told to take tylenol and she just had been taking tylenol and drinking water for her headache. Caller stated that she was continuing that thing - she was feeling fever and wanted to know. They were taking her temperature and it was 98 points and she was concerned about her fever. Caller stated that they told her husband to give her water and rest which did not work. She did not call because she was so weak and she usually has a good appetite but she did not have an appetite. Caller got her injection at this hospital and this was where she has her primary. Caller did not provide any additional details. Her stomach was hurting, she could not eat anything it was so terrible. Puking and throwing up: first of all, that day, when she went for her vaccine she went to come from work in the morning at 9:45 and went for the injection and they said it was horrible, she felt dizziness, she was sleepy the whole night so she thought she was sleeping like she felt the need to sleep and fell asleep immediately at 11 so that night she was feeling dizzy and weak. She was weak and dizzy and because she was sleepy she woke up around 7 in the evening to get ready for work and that was when she woke up. She fell on the floor, felt a shock and a fall. She started throwing up and her husband came and picked her up because he did not want her to choke because she was sleeping down on the floor. That is when she started throwing up and he gave her a container to throw up. He gave her one to do it, but she was feeling like she could not hold anything and was puking and felt a headache pounding up and felt like everything was going around like she was feeling dizzy. Caller clarifies she does not know what it is called, everything is going around and at that time she was out of breath from the puking. She did not eat because she slept there and there was nothing to puke so she was forcing something to come out so it was just she did not have anything in her stomach to come up. She woke up, and was asleep, she did not know what happened when she went to sleep and when she woke up too. Caller did not provide clear timeline and was asked regarding if events are still occurring and she states for now, the dizziness is not now and was not coming. The headache she takes tylenol now and she takes tylenol when she feels feverish. Caller stated what led her to call Pfizer was about the stomach problems and not eating. Also, the pain that was sharp and was going and it was not constipation but a sharp pain. She did not know how she can describe it a lot, she was having troubles like a stomachache. When she ate something, like the more she eats, like a little pancake one week, he said do not eat because she did fasting and did not have an appetite. When she ate and drinks it was like drinking a lot of water, she could not even drink things she likes. Caller added she was sure she did not have Covid because of every week they get a test. The reporter seriousness for all the events was unspecified. Patient was taking tylenol for headache and fever. The patient underwent lab tests and procedures which included body temperature: 98 points on 08Jun2021, and COVID-19: negative on an unspecified date. The outcome of event dizziness and could not get self up was recovered on an unspecified date while unknown for all other events.; Sender's Comments: Based on plausible temporal relationsip the causal role of the suspect vaccine bnt162b2 cannot be excluded for reported adverse events The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate

Other Meds:

Current Illness:

ID: 1442651
Sex: M
Age:
State: OK

Vax Date:
Onset Date:
Rec V Date: 07/02/2021
Hospital: Y

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: sick since getting the shot and has been in the emergency room 3 times in the last month half; This is a spontaneous report from a contactable consumer. A nearly 80-year-old elderly male patient received bnt162b2 (COVID-19 VACCINE -MANUFACTURER UNKNOWN), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) and dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included ongoing chronic bone disease and disabled from 2008 and Sick. The patient's concomitant medications were not reported. Covid 19 Vaccine and who explains he was a disabled person and who went to the hospital twice for the vaccine. He is not sure the type, they told him very little about the vaccine, but it did him no good. He has been disabled since 2008. He saw all this going on TV and got 2 letters 4 weeks apart from the hospital saying he needed to come get the vaccine so he went on down and got it. Whatever vaccine he got, it didn't help. He doesn't know what he was ill with but he has been in the hospital 3 times. Reporter explains he has rare blood, AB negative and positive blood but no one ever asked him about that. The reporter explains he was still sick. He was told he needed the vaccine. He has been in the hospital 3 times. The product he got, it was secret, the hospital didn't tell him but just told him to come and get it. Reporter confirms he doesn't know if he got the Pfizer vaccine but it was given 4 weeks apart (has no NDC, Lot, or Expiry). Reporter explains he doesn't want to do a report, he wants to get our product because what he got didn't work. When they brought out the needle, he just saw the syringe with a little bit of liquid in it, just a tiny bit. That is what they gave him, just that little bit. Caller confirms he has been sick since getting the shot and has been in the emergency room 3 times in the last month half. He explains that he has been sick before the vaccine also, he has a chronic bone disease. When he goes to the ED they got too much going on there to help. He has not been given any test result, caller does not know if he had COVID after the shot. He just wants to get medication to help him. He is not sure he is getting enough. When caller is referred back to his HCP the caller explains he has an appointment coming up but wants to know what we can do to help him. He was sick and saw where there was some disorder out there that was killing people so he went out there quick as he could to get the shot. Now he is sick and wants to know what we are doing. He saw an advertisement on tv about all this. Caller reporting on the Covid 19 Vaccine and who explains he is a disabled person and who went to the hospital twice for the vaccine. He is not sure the type, they told him very little about the vaccine, but it did him no good. Whatever vaccine he got, it didn't help. He doesn't know what he was ill with but he has been in the hospital 3 times. He has not been given any test result, caller does not know if he had COVID after the shot. Caller explains he doesn't want to do a report, he wants to get our product because what he got didn't work. At the time of this report event patient not recovered the event. Information about lot/batch number has been requested.

Other Meds:

Current Illness: Bone disorder (He has a chronic bone disease.); Disability (He is a disabled)

ID: 1442652
Sex: F
Age:
State: CA

Vax Date: 06/07/2021
Onset Date:
Rec V Date: 07/02/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: Arm sore; This is a spontaneous report from a Pfizer Sponsored Program COVAX US Support. A contactable female consumer reported that: A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Unknown), via an unspecified route of administration on 07Jun2021 as dose 2, single for COVID-19 immunisation; medroxyprogesterone acetate (DEPO-PROVERA, Formulation: Suspension for injection, Lot Number: UNKNOWN), via an unspecified route of administration on 16Jun2021 as dose number unknown, single for birth control. The patient medical history and concomitant medications were not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Unknown), via an unspecified route of administration on an unknown date as dose 1, single for COVID-19 immunisation. No investigation assessment was provided. It was reported that she got a second dose on 07Jun2021 and had a doctor appointment "today". She said that the doctor injected a medication, in the same site, that she got her vaccine. She reported that the area hurt a little more "today", then when she got her vaccine. She confirmed that she was calling about the Pfizer vaccine for COVID virus. She reclarified that she got the second vaccine on 07Jun2021, and "today", she went to the doctor for her birth control, for the Depo shot (medroxyprogesterone acetate). She didn't think about anything, until later. She asked if it was alright, that she got the vaccine and her Depo shot, in the same site and if there would be an interaction. She clarified that her arm was sore, originally, from the COVID vaccine and stated her arm is also sore, from the Depo shot. The outcome of event was reported as unknown. Information on lot/ batch number has been requested.

Other Meds:

Current Illness:

ID: 1442653
Sex: F
Age:
State: VA

Vax Date: 06/15/2021
Onset Date: 06/15/2021
Rec V Date: 07/02/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: doctor told her that it was an adverse reaction to the vaccine and not to get the second dose; She's been sleeping for days so she is not feeling well; She's been sleeping for days so she is not feeling well; Broke out in hives and hives went around her mouth; Throat was getting swollen; This is a spontaneous report from a contactable consumer (parent). A 22-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number was not reported; Expiration Date: Aug2021, patient was 22-year-old at the time of vaccination), via an unspecified route of administration in Arm Left on 15Jun2021 at 08:00 as single dose for covid-19 immunisation. No medical history was reported. Concomitant medication(s) included spironolactone and birth control (unspecified). Reported that caller was not sure about lot number, it just says EW, it could be 0 or it could be an O, it just says EW it might be 0, its just say EW0178 or O187, I am not sure. It was reported that caller reported on behalf of patient and stated that caller and her daughter got a vaccine on Tuesday morning and Tuesday afternoon, she broke out in hives and I had to take her to the emergency room and get her shot of epinephrine (Treatment) and they put her prednisone (Treatment) on because her hives were around to her mouth and throat was getting swollen and their doctor told her that it was an adverse reaction to the vaccine and not to get the second dose and they told us to call an report it. she's been sleeping for days so she is not feeling well. Patient was about about 5 (feet) 7 (inches) and about 200 (pounds) and she will be 23 on Saturday. Patient not received prior Vaccination within four weeks. On 15Jun2021, the patient experienced broke out in hives and hives went around her mouth, throat was getting swollen, on an unspecified date, She won't be getting her second dose, she's been sleeping for days so she is not feeling well. Reporter seriousness for Broke out in hives and hives went around her mouth, Throat was getting swollen, she's been sleeping for days so she is not feeling well was unspecified. Patient visit emergency room after the Broke out in hives and hives went around her mouth, Throat was getting swollen. Reported that the hives went away, and they have not come back, she just went all off. Reported that doctor said that we should call because she has definitely a serious reaction so, she won't be getting her second dose, but I will. Patient received treatment for event (broke out in hives and hives went around her mouth and throat was getting swollen). The outcome of event (broke out in hives and hives went around her mouth) was recovered on an unspecified date in 2021 and the outcome of events (Throat was getting swollen, she's been sleeping for days so she is not feeling well) was unknown. Information about lot/batch number has been requested.

Other Meds: SPIRONOLACTONE

Current Illness:

ID: 1442654
Sex: M
Age:
State: CO

Vax Date: 03/01/2021
Onset Date: 03/01/2021
Rec V Date: 07/02/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: This is a spontaneous report from a contactable physician. A 30-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration on Mar2021 (Batch/Lot number was not reported) (Age at Vaccination 30 years) as DOSE 2, SINGLE for COVID-19 immunization. Medical history included transgender operation from an unknown date and unknown if ongoing, anaemia from an unknown date and unknown if ongoing , haematuria from an unknown date and unknown if ongoing. Concomitant medication(s) included estradiol (ESTRACE) 2 mg TID; spironolactone (SPIROLACTONE) 50 mg TID; ibuprofen (IBUPROFEN) 200mg PRN and vitamin d3 (VITAMIN D3) 200u one daily. The patient historical vaccine included (BNT162B2), dose 1 via an unspecified route of administration on unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE for COVID-19 immunisation and had no adverse event. The patient referred to nephrology for evaluation of proteinuria and microscopic hematuria in the setting of the second dose of the COVID 19 vaccine. It was wondered if there wasn't an autoimmune reaction like HSP or IgAN type syndrome. Kidney biopsy preformed, confirmed IgA Nephropathy, primary and secondary forms as well as infection on unknown date in Mar2021. If primary IgA nephropathy the findings are consistent with Oxford Classification of MI E0 S1 T0 C0. The outcome of the events was not resolved. Information on Lot/Batch number was available. Additional information has been requested; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events and suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Other Meds: ESTRACE; SPIROLACTONE; IBUPROFEN; VITAMIN D3

Current Illness:

ID: 1442655
Sex: F
Age:
State: MI

Vax Date: 05/27/2021
Onset Date: 06/17/2021
Rec V Date: 07/02/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: I woke up with severe hearing distortion in my left ear.; This is a spontaneous report from a contactable consumer (patient). A 32-year-old non pregnant (including at the time of vaccination) female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 27May2021 09:45 (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization at the Pharmacy or Drug Store. Medical history reported as none and there were no concomitant medications. On 17Jun2021 05:45, the patient woke up with severe hearing distortion in her left ear. She made a doctor or other healthcare professional office/clinic visit and received steroids as treatment. The patient was not diagnosed with COVID-19 prior to vaccination and not tested for COVID-19 since the vaccination. Outcome of the event was not recovered. Information about lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1442656
Sex: F
Age:
State: MA

Vax Date: 03/01/2021
Onset Date: 03/04/2021
Rec V Date: 07/02/2021
Hospital: Y

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: Not eating, unable to eat without choking.; Not eating, unable to eat without choking.; Couldn't swallow; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 79-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection Batch/Lot number was not reported) via an unspecified route of administration on 01Mar2021 as dose 1, single for COVID-19 immunization.Medical history included gastrointestinal issues and high blood pressure. The patient's concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, it is unknown the patient been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine, other medications the patient received within 2 weeks of vaccination was high blood pressure meds, pain meds.On 04Mar2021, the patient was not eating, unable to eat without choking. Couldn't swallow. Adverse event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization, disability or permanent damage. Duration of hospitalization was 30. The patient had not yet recovered from the event.

Other Meds:

Current Illness:

ID: 1442657
Sex: F
Age:
State: WI

Vax Date: 01/06/2021
Onset Date: 05/06/2021
Rec V Date: 07/02/2021
Hospital: Y

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: Urticarial vasculitis; Pruritic raised bullseyes blotches with bruises in the middle; Pruritic raised bullseyes blotches with bruises in the middle; Pruritic raised bullseyes blotches with bruises in the middle; Pruritic raised bullseyes blotches with bruises in the middle; This is a spontaneous report received from a contactable nurse (patient). A 60-year-old non-pregnant female patient (not pregnant at the time of vaccination) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: el1284 expiration date: unknown), via an unspecified route of administration in left arm on 06Jan2021 at 10:00 AM (at the age of 60 years old), as single dose for covid-19 immunization. Medical history included gastrooesophageal reflux disease from an unknown date and unknown if ongoing. The patient had known allergies to sulfa and Wellbutrin. Concomitant medications the patient received within 2 weeks of vaccination included famotidine; and vitamin d for an unspecified indication, start and stop date were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EK5730 expiration date: unknown), via an unspecified route of administration in right arm on 16Dec2020 at 10:00 AM (at the age of 60 years old) for covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced urticarial vasculitis developed symptoms On 06May2021, with pruritic raised bullseyes blotches with bruises in the middle. Treated with unspecified iv steroid, antihistamines and continued steroids and taper to colchicine. The adverse event result in: Doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization. The patient was hospitalized for one day. The outcome of events of Urticarial vasculitis, Pruritic raised bullseyes blotches with bruises in the middle was recovering. Reporter considered events as serious. Information on Lot/Batch number was available. Additional information has been requested. ; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events and suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Other Meds: FAMODITINE; VITAMIN D [VITAMIN D NOS]

Current Illness:

ID: 1442658
Sex: F
Age:
State:

Vax Date: 03/01/2019
Onset Date: 01/01/2021
Rec V Date: 07/02/2021
Hospital: Y

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: Tiredness/ tired easily; Viral infection/caught a virus; Small bowel obstruction; Dose 1 on 25Mar2021; Dose 2 on 12Apr2021; This is a solicited report based on the information received by Pfizer from AbbVie Inc. (MFR Con-trol No. # 21K-163-3926388-00). A non-contactable consumer (patient) reported that a 34-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscular on 12Apr2021 (lot number and expiry date: unknown) at the age of 34-years-old as dose 2, single; intramuscular on 25Mar2021 (lot number and expiry date: unknown) at the age of 34-years-old as dose 1, single, for COVID-19 immunisation; adalimumab (HUMIRA), subcutaneous from Mar2019 (lot number and expiry date: unknown) to 27Apr2021, at 8571 mg (40 mg,1 in 2 wk) for Crohn's disease. Medical history included tobacco user from 2004 to May2021 , alcohol user from 2008 to an unknown date, acute myeloid leukaemia from 2017 to an unknown date, smoker, small intestine resection surgery in May2021 (Patient had an inpatient small intestine resection in May2021), and stomach spasm. The patient had a family history of acute myeloid leukemia. Concomitant medications included varenicline tartrate (CHAMPIX) to quit smoking, start and stop date were not reported; metoprolol taken for high blood pressure, start and stop date were not reported; dicyclomine taken for stomach spasm, start and stop date were not reported; venlafaxine hydrochloride (EFFEXOR) taken for antidepressant; start and stop date were not reported; and Tri-Trezisem. The patient previously took morphine and experienced allergy. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On an unknown date, the patient was tired easily (tiredness) and caught a virus (viral infection). In Jan2021, the patient experienced small bowel obstruction. The patient was told to quit smoking and was too clean without smoking. She had small intestine re-section surgery and was told not to take HUMIRA during surgery. She also had caught a virus and got over it as of 27May2021. The patient stated that she was told by her doctor that smoking was the cause of her small bowel obstruction. The patient underwent inpatient small intestine resection in May2021. The events tiredness, small bowel obstruction and viral infection/caught a virus were considered serious due to hospitalization on unspecified date, and due to other medically important condition. The patient underwent magnetic resonance imaging in Mar2021 which showed small bowel obstruction. Outcome of the events tiredness and small bowel obstruction was recovering, while for viral infection/caught a virus was recovered on 27May2021. The last action taken in response to the events for adalimumab was dose not changed. Causality for HUMIRA (adalimumab): The reporter's causality for the events of small intestine resection, tired easily and caught a virus was not provided. The reporter's causality for the events of small bowel obstruction with HUMIRA (ADALIMUMAB) was reported as "no reasonable possibility". The company (AbbVie Inc.) assessed that there is no reasonable possibility that the events of small intestine re-section, tired easily and small bowel obstruction are related to HUMIRA (ADALIMUMAB). The company also assessed that there is a reasonable possibility that the event of caught a virus is related to HUMIRA (adalimumab). No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on the current available information, the events Tiredness, Viral infection, Small bowel obstruction are most likely related to an intercurrent or underlying condition which is not related to the suspected drug. Medical history of acute myeloid leukaemia may provide an explanation for the event of Tiredness and Viral infection; Crohn's disease may provide an explanation for the event of Small bowel obstruction. The case will be reassessed if additional information becomes available.

Other Meds: CHAMPIX; METOPROLOL; DICYCLOMINE; EFFEXOR

Current Illness: Tobacco user

Total 2021 VAERS Injuries: 704,237

Page last modified: 03 October 2021 5:28pm