VAERS 2021 Database www.vaers.hhs.gov

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

Total Manufacturer

Incidents per State

State Total
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: 1509072
Sex: M
Age:
State:

Vax Date: 06/03/2021
Onset Date: 06/29/2021
Rec V Date: 07/28/2021
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Symptoms: Itchy hives but it was worse yesterday; He also slept for like 10-11 hours last; Hives; Itchy hives; This is a spontaneous report from a contactable consumer reported for a patient. A 13-years-old male patient received second dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 03Jun2021 as dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took first dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported) via unspecified route of administration for covid-19 immunization, past drug event was reported amoxicillin and experienced urticaria, azithromycin and experienced urticaria (had hives before after taking amoxicillin and azithromycin but they were smaller and stopped after a day or two, as reported). On 29Jun2021, the patient experienced hives, on an unspecified date of 2021 itchy hives, but it was worse yesterday on 12Jul2021, he also slept for like 10-11 hours last on Jul2021. Reportedly, a friend wrote [Son] has had terrible hives for 2 weeks. I feel so bad for him. We went to an allergist yesterday who put him on a ton of meds- it seems to be helping. I asked what is triggering the hives. She responded I can't tell you. Because she knows I'm obligated to report AEs. Then she wrote: Actually the allergist isn't sure. It's not food and she thinks environmental is unlikely. But we are waiting for bloodwork. So could be normal allergy. I feel terrible for him, he so uncomfortable. The increased meds yesterday seemed to help bc his whole body isn't red and hot. He still has itchy hives but it was worse yesterday. He also slept for like 10-11 hours last night, so he had enough relief to actually sleep. He has had hives before after taking amoxicillin and azithromyocin but they were smaller and stopped after a day or two. Therapeutic measures were taken as a result of hives, itchy hives. The outcome of the events hives, itchy hives was not recovered, the outcome of other events was unknown. Information on lot/Batch number has been requested.

Other Meds:

Current Illness:

ID: 1509073
Sex: F
Age:
State: SC

Vax Date: 05/17/2021
Onset Date: 06/04/2021
Rec V Date: 07/28/2021
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Symptoms: when i was out in the sun for 45 minutes I burned extensively and after 3 weeks I am still red.; I didn't even burn my legs and they started peeling; when i was out in the sun for 45 minutes I burned extensively and after 3 weeks I am still red.; This is a spontaneous report from a contactable consumer. A 47-years-old female patient received BNT162B2 (Formulation: Solution for injection; Batch/Lot number: unknown), via an unspecified route of administration, administered in Arm Left on 17May2021 17:00 (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history was not reported. Concomitant medications included lamotrigine (LAMICTAL), methotrexate (METHOTREXATE), meloxicam (MELOXICAM), hydroxychloroquine sulfate (PLAQUENIL [HYDROXYCHLOROQUINE SULFATE]), methylprednisolone (PRED [METHYLPREDNISOLONE]) taken for an unspecified indication, start and stop date were not reported. The patient previously took sulfa, phenargan plus for drug hypersensitivity. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 04Jun2021 patient reported when she was out in the sun for 45 minutes she burned extensively and after 3 weeks she is still red. She peeled but my skin was scaley, it isn't the usual sunburn she gets. She didn't her sister had same issue. The patient underwent lab tests and procedures which included sars-cov-2 test (Nasal Swab): negative on 09Jun2021. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient been tested for COVID-19. The outcome of the event was recovering.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021895011 same reporter, drug and event, different patient

Other Meds: LAMICTAL; METHOTREXATE; MELOXICAM; PLAQUENIL [HYDROXYCHLOROQUINE SULFATE]; PRED [METHYLPREDNISOLONE]

Current Illness:

ID: 1509074
Sex: U
Age:
State: NJ

Vax Date: 07/06/2021
Onset Date: 07/07/2021
Rec V Date: 07/28/2021
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Symptoms: Heartburn; Inflamation; Soreness in pectoral muscles; slight pain also in pectoral muscles.; This is a spontaneous report from a contactable consumer (patient) reported in response to consumer letter sent via follow-up letter. A patient of unspecified age and gender received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EW0186) via unspecified route of administration, administered in Arm Left on 06Jul2021 at 10:30 as single dose for covid-19 immunisation. Vaccination facility type was Doctor's office/Urgent care. No prior vaccinations reported. Medical history included olfacto genital dysplasia. The patient's concomitant medications were not reported. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number EW0182) via unspecified route of administration, administered in Arm Left on 25May2021 10:30 as single dose for covid-19 immunisation. On 07Jul2021 at 10:00, the patient experienced inflammation, soreness in pectoral muscles and slight pain also in pectoral muscles. Also have heartburn started on 08Jul2021 and the patient have never had that before. Heartburn on 08Jul2021 and on 09Jul2021. The adverse event was required in a visit to Physician office. The patient had no treatment received for the adverse events. The outcome of the event Heartburn recovered on 09Jul2021 and recovering from the events inflammation, soreness in pectoral muscles and slight pain also in pectoral muscles.

Other Meds:

Current Illness:

ID: 1509075
Sex: F
Age:
State:

Vax Date: 02/02/2021
Onset Date: 02/01/2021
Rec V Date: 07/28/2021
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Symptoms: Her eyes being itchy; Eye tearing; Her eyes being red; This is a spontaneous report from a contactable consumer (patient). A 78-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Unknown), via an unspecified route of administration on 02Feb2021, as dose 2, single for COVID-19 immunization. The patient's medical history was not reported. Concomitant medication taken 2 weeks after the first dose included varicella zoster vaccine rge (cho) (SHINGRIX) from Jan2021, taken for an unspecified indication, stop date was not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Unknown), via an unspecified route of administration on 12Jan2021, as single dose for COVID-19 immunization. On an unspecified date in Feb2021, the patient's eyes were being itchy and red; and had eye tearing since the second shot. The patient was prescribed with eye drops. The clinical outcome of the events was reported as not resolved. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1509076
Sex: M
Age:
State: IN

Vax Date: 02/01/2021
Onset Date: 02/01/2021
Rec V Date: 07/28/2021
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Symptoms: euphoric feeling; This is a spontaneous report from a contactable consumer or other non hcp. This case was split to capture events after first and second dose of vaccine. This is the first of two reports, reflecting events after the 1st dose. A 52-years-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot No was not reported), via an unspecified route of administration, administered in Arm Right on Feb2021 as 1stdose, single, for covid-19 immunisation. Historical vaccine was Flu Vaccine which got started the Flu Vaccine back in September. Medical history included nephrolithiasis from an unknown date and unknown if ongoing , diabetes mellitus from an unknown date and unknown if ongoing. Concomitant medication(s) included insulin aspart (NOVOLOG) taken for diabetes mellitus, start and stop date were not reported; insulin glargine (LANTUS) taken for an unspecified indication from an unspecified start date and ongoing; atorvastatin (ATORVASTATIN) taken for blood triglycerides decreased, blood cholesterol from an unspecified start date and ongoing; dapagliflozin propanediol monohydrate (FARXIGA) taken for diabetes mellitus from an unspecified start date and ongoing; lisinopril (LISINOPRIL) taken for hypertension from an unspecified start date and ongoing; carvedilol (CARVEDILOL) taken for blood triglycerides increased from an unspecified start date and ongoing; lorazepam (ATIVAN) taken for anxiety from an unspecified start date and ongoing; sertraline hydrochloride (ZOLOFT) taken for sleep disorder from an unspecified start date and ongoing. The patient experienced euphoric feeling on Feb2021. Patient is a 52-year-old male who has a medical history of diabetes and received the first dose of the Pfizer Covid-19 vaccine back in Feb2021 and had complaints of a euphoric feeling and had the second dose of the Pfizer Covid-19 vaccine back in Mar2021 and felt "sick", had complaints of nausea, felt as if he was "beaten with a baseball bat from head to toe", and afterwards he started developing bone pain and numbness in his hands to elbows with "knots" that appeared. Patient states that he still has numbness and bone pain, but the pain is getting better. Has been to rheumatologists and doctors for complaints he experienced after being administered the second dose of the Pfizer Covid-19 vaccine and HCP wants to put him on pain medication per patient and is asking how long will his side effects last and if the side effects are normal, patient is asking if he will return to 100percentage, asking if information can be provided to his employer regarding his side effects, if there is a doctor that works for Pfizer that would know about his side effects, asking to speak with someone "higher" about information on his side effects. Patient states that he doesn't believe no one else has not had his side effects and feels that there is more information about what he is experiencing. Patient states that You guys are trying to brush me off. Patient stated he is 52 years old; a very active guy and he took the first shot and did not notice much of it. He then stated he had like a euphoric feeling that went away like initially sounded like stated 3 hours. However, after getting the second vaccine, two days after that everything changed, and he and his body was never the same. HCP details patient stated we can call every one of his doctors. He has several of them that he has had to see due to this. He confirmed all the doctors are at Hospital with the same address. Diabetes Doctor withheld- Rheumatologist, sated saw this doctor the first time today. withheld- Cancer Doctor withheld- Neurologist. Event Details was confirmed after the first dose he had a euphoric feeling. He clarified it went away after one hour and no problem after it. He received the first dose sometime in Feb2021, he does not remember the exact date. It was towards the end of Feb2021. After the second dose, sometime in Mar2021. Stated it would have been three to four weeks after the first one. Stated hospital would have record of when he received the COVID Vaccine. He further clarified not being the same as, He stated he has worked the same job for 23 years. After getting this vaccine he has missed more work than before. He never missed work over covid. He has missed more work than ever in life. He now has knots coming all over his hands. He has had to see two rheumatologists so far and his family doctor. The pain started two days after getting the second dose. The pain went from his elbows, down to his hands, and knuckles. He stated he no longer has any pain. It slowly went away. The pain started going away three weeks ago. He did not take any pain medicine. He does not take drugs or alcohol. The knots on his hands started coming up slowly. It was not overnight. It was within 3?4-week time period it started to come up. He showed all of this to the doctor and told this is not right. He did not have anything until he got the Pfizer vaccine. The knots are almost gone, not 100% gone, but almost gone. The knots did not really hurt. However, the knots did move around with a little pain. The pain was not that bad. Numbness: He stated he still cannot feel his hands. They are so freaking numb. He cannot feel his fingers. He started to feel numb three days after the second dose. It started and then got worse. He could not pick up his hammer. The pain was so excruciating. He reiterated he was very active, physical, exercised, ride bike each day. He worked hard all his life and did not really have pain except back pain before the vaccine. After day two he started to have pain like never before. It's like the vaccine attacked something in his body. He later, confirmed the numbness is getting better at this time. The numbness uses to be from his elbows down. Caller questioned when he would get the feeling back. During interaction, caller got upset and stated, "this should have been," but did not complete sentence. He then stated he was trying to do each thing right. Now two doctors so far have told him to never take the COVID vaccine again. He cannot take the booster if one is offered of any kind. He was just trying to do the right thing and as a result he missed all kinds of work. At work he is getting his ass ringed at work because he goes the COVID Vaccine, and he could not perform his job the way he usually would be able to due to the pain. Stated, now he is back to working 90% now. He got upset and stated this vaccine should have been studied more. He wants to know why it would affect him like this. He mentioned his other family members go the COVID Vaccine and they had no problems related to this product. Patient did not have vaccination card with him to provide lot/exp/NDC of first or second dose which was stated it is at home. He confirmed he got both doses in right arm. The right one where got shot in was double as bad with the knots than the left. The pain was worse in the right arm than left a little bit. Mentioned he is right-handed and uses his right hand more. Indication: He got the vaccine because he had not seen mom or dad in almost a year. They live in a senior living facility and could not see without getting the covid vaccine. Concomitant Medications: He mentioned all of these medications he has been on for the last 15 years Investigations: Stated has has so much lab work done in the last 3-4 months. Has had enough lab work to last a lifetime. Now he has a paper to get it done again. He does not have any specific results to provide. He stated the doctor has it and he does not know what these codes mean. At end of call, he commented this vaccine is safe for like 99.99% of people, but it was not safe for him. It's not safe because one would not have these effects and then it slowly starts to go away if it was safe. Outcome of the event was recovered. Information about lot/batch number has been requested.

Other Meds: NOVOLOG; LANTUS; ATORVASTATIN; FARXIGA; LISINOPRIL; CARVEDILOL; ATIVAN; ZOLOFT

Current Illness:

ID: 1509077
Sex: F
Age:
State:

Vax Date: 07/13/2021
Onset Date: 07/14/2021
Rec V Date: 07/28/2021
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Symptoms: nausea/completely nauseous; bad headache; felt really sick; arm was also sore; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number, NDC number and Expiry Date were not provided), via an unspecified route of administration on 13Jul2021 at 12:30 in the afternoon as dose 2, single dose for covid-19 immunisation. Patient history he had COVID in December, but she just feels really sick. The patient's concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1, on an unspecified date for covid-19 immunization. She stated that she got her 2nd dose of the Pfizer BioNTech Covid-19 vaccine yesterday 12:30 in the afternoon and on 14Jul2021, she felt really sick around 2 or 3 in the morning of the following day, her arm was also sore, it started out as a bad headache and had progressed to nausea. She took some Advil to relieve the headache, but she is still feeling the side effects of the vaccine. She states that she's just feeling really sick after the second dose. She states she's completely nauseous, she has a bad headache, she just feels really sick. She states she doesn't know what to do. She asked, is it normal to feel nauseous after? she just wanted to know if what she's feeling is normal, she just hates feeling like this. She wanted to know if feeling nausea, bad headache, and feeling unwell are among the commonly reported adverse events after getting the Pfizer BioNTech Covid-19 Vaccine. She confirmed that the product she received and is speaking of was the Pfizer Covid 19 Vaccine. She stated that it was the Pfizer 19, Covid Vaccine number two, she got it done. Reporter seriousness for nauseous, bad headache and just feels really sick was unspecified. The outcome of events was unknown. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1509078
Sex: M
Age:
State: GA

Vax Date: 04/20/2021
Onset Date: 04/01/2021
Rec V Date: 07/28/2021
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Symptoms: runny nose for a few hours; This is a spontaneous report from a contactable consumer (patient) reported for himself. A 49-year-old male patient received bnt162b2 (BNT162B2, Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 20Apr2021 09:15 as dose 1, single for covid-19 immunization. patient received 2nd vaccination shot on 19May2021 at approximately 9:30 AM Eastern. The patient medical history and concomitant medications were not reported. On an unspecified date in Apr2021 patient experienced runny nose for a few hours. Reportedly, I am writing this letter to request financial assistance with my medical bills. Consumer request was 2 fold, first to get financial assistance that will cost me thousands in out of pocket expenses due to these tests to see what is going on. I shouldn't have to spend the next few years paying off medical expenses because of a vaccination shot, and second to make Pfizer aware of this situation. The outcome of event was recovered on an unspecified date in Apr2021. Information about Lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1509079
Sex: F
Age:
State: IN

Vax Date: 06/29/2021
Onset Date: 06/30/2021
Rec V Date: 07/28/2021
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Symptoms: received the 1st dose of the Pfizer covid vaccine but tested positive to covid 5 days after; Vomited; got really shaky; not able to drive; bad headache; This is a spontaneous report from a contactable pharmacist. A 17-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 vaccine, formulation: solution for injection, Batch/Lot Number: EW0198), dose 1 via an unspecified route of administration, administered in Deltoid Right on 29Jun2021 (17-year-old at the time of vaccination) as dose 1, single for covid-19 immunisation. Medical history reported as none. Concomitant medication(s) included fluoxetine hydrochloride (PROZAC) 40 mg once daily taken for an unspecified indication, start and stop date were not reported. On 30Jun2021, the patient experienced Vomited, got really shaky, not able to drive and bad headache. The patient received the 1st dose of the Pfizer covid vaccine but tested positive to covid 5 days after sars-cov-2 test positive on 05Jul2021. The reporter stated her daughter received the first dose and then ended up testing COVID positive. She received her first Pfizer Vaccine and she ended up with Covid positive, 5 days later. So, my question is with her second vaccine, do they recommend any way or not, should we, because she had the first one and became infected. She also had side effects from the first vaccine. Side effects: Pharmacist stated," I know she vomited, she got really shaky, really bad headache and she was not able to drive." Laboratory test: Pharmacist stated, "No lab but she tested COVID positive e on 05Jul2021 from 'PCR' (Not spelled) COVID test. The outcome of the events were unknown. The patient underwent lab tests and procedures which included PCR sars-cov-2 test: positive on 05Jul2021. No follow-up attempts are possible. No further information is expected.

Other Meds: PROZAC

Current Illness:

ID: 1509080
Sex: F
Age:
State: CA

Vax Date:
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Rec V Date: 07/28/2021
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Symptoms: daughter has had serious hives all over her body; This is a spontaneous report from a contactable consumer. A 35-years-old female patient (reporter's daughter) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number was not reported, patient was 35-year-old at the time of vaccination), on an unspecified date as single dose for covid-19 immunisation and no adverse reaction experienced. It was reported that patient was perfectly healthy and has had serious hives all over her body after the she got the second Pfizer vaccine for COVID and this has gone on for three months. Nothing she has tried has worked and it's really a terrible situation. I think this is a more common occurrence than we know and wonder if you recommend anything. On an unspecified date, the patient experienced daughter has had serious hives all over her body. Patient received treatment for event. The outcome of event was unknown. Information about lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1509081
Sex: F
Age:
State:

Vax Date: 03/09/2021
Onset Date: 03/10/2021
Rec V Date: 07/28/2021
Hospital: Y

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Symptoms: Urinary tract infection; Pain; unable to walk; lack of mobility and that it take 1 and sometimes 2 people to assist her; becoming more depressed and hopeless; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration on 09Mar2021 (Batch/Lot number was not reported) (at the age of 70-year-old) as dose number unknown, single for covid-19 immunisation; alglucosidase alfa (ALGLUCOSIDASE ALFA), intravenous from 16May2006 (Batch/Lot number was not reported) and ongoing, at 2200 mg every other week, then from 04Jun2021 at unspecified dose for Pompe's disease. Medical history included Pompe's disease. The patient's concomitant medications were not reported. On 19Mar2021, patient was admitted for a urinary tract infection and pain (both assessed as serious due to hospitalization) and the medical team was concerned about her lack of mobility and that it take 1 and sometimes 2 people to assist her (serious: disability) and because of that, the medical team was recommending patient go to a skilled nursing facility. Therapy with alglucosidase alfa was ongoing. On 09Mar2021 the patient received Pfizer biontech covid-19 vaccine, unknown formulation, dose, route and frequency (with an unknown batch number). On 10Mar2021 after a latency of 14 years 9 months 22 days, the patient could not walk for which patient was hospitalized and was sent to a nursing home and was now living in assisted living. The patient will not restart the treatment as she cannot walk and was in assisted living. And patient is increasingly becoming more depressed and hopeless. The action taken in response to the events for alglucosidase alfa was unknown. The outcome of events was unknown. Reporter causality: unassessable for depression and couldnt walk, not reported for rest events. Company causality: not reportable for all the events. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

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Current Illness:

ID: 1509082
Sex: F
Age:
State: NC

Vax Date: 06/07/2021
Onset Date: 06/11/2021
Rec V Date: 07/28/2021
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Symptoms: feel sick; agitated; I had red swollen spots eczema on my arms then lower legs after two days; I also am having more fatigue with physical effort -after very simple tasks such as climbing stairs; This is a spontaneous report from a contactable consumer (Patient herself). A 51-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 07Jun2021 at 16:30 (at the age of 51-year-old) as single dose for covid-19 immunisation at Pharmacy or Drug Store. Patient was not pregnant at the time of vaccination. Medical history included depression, anxiety and sleep issues from an unknown date and unknown if ongoing. The patient was not diagnosed with COVID-19 before vaccination. Patient had no known allergies but very sensitive to any medications. Concomitant medication(s) included zinc (ZINC); vitamin d [vitamin d nos] (VITAMIN D [VITAMIN D NOS]); ubidecarenone (Q10); st john's wort (ST JOHN'S WORT) and panax ginseng (GINSENG [PANAX GINSENG]) 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. Patient received zinc, vitamin D, Q10, saint John's wort and Ginseng within 2 weeks of vaccination. Patent reported I started to feel sick and agitated, not being able to do anything after 3 days of having the second dose not really being aware from what it is from. I had it on Monday at 4 pm and on Sunday I was at the urgent care in another state where I was travelling because starting on Saturday, I had red swollen spots of eczema on my arms then lower legs after two days I called again to my virtual doctor and had a virtual visit. had a pack of methylprednisolone and after it I tried prednisone few days and went back for another few days on methylprednisolone ll this time I took Claritin orally at the end I started using Hydrocortisone cream and zinc cream and hypnosis those last worked so I improved after 2 weeks minimum I want refund for all my urgent care visit and copy for my virtual visit and all over the counter creams I had to purchased I also I am having more fatigue with physical effort after very simple tasks such as climbing stairs I plan to see a cardiologist. Since vaccination patient not tested for covid-19. This case assessed as non-serious by the reporter. Events resulted to visit Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Therapeutic measures were taken as a result of the events with methylprednisolone, prednisone, Claritin orally, Hydrocortisone cream and zinc cream and hypnosis. The outcome of the events was reported as recovering. Information on the Batch/lot number has been requested.

Other Meds: ZINC; VITAMIN D [VITAMIN D NOS]; Q10; ST JOHN'S WORT; GINSENG [PANAX GINSENG]

Current Illness:

ID: 1509083
Sex: F
Age:
State: NJ

Vax Date: 03/06/2021
Onset Date: 03/16/2021
Rec V Date: 07/28/2021
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Symptoms: Swollen lymph nodes, checked 3 months later with ultrasound and seems resolved; This is a spontaneous report from a contactable consumer (patient). A 53-years-old female patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EN6199) via an unspecified route of administration, administered in left arm on 06Mar2021 (at the age of 53-years-old) as dose 1, single for COVID-19 immunization. Medical history included dystonia and migraines. The patient concomitant medications were not reported. The patient previously took erythromycin and experienced drug hypersensitivity. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications the patient received within 2 weeks of vaccination was yes. Prior to vaccination was the patient diagnosed with covid-19 was no. Since the vaccination, the patient did not test for covid-19. Patient is not pregnant at time of vaccination. On 16Mar2021, the patient experienced swollen lymph nodes, checked 3 months later with ultrasound and seems resolved. The patient underwent lab tests and procedures which included ultrasound scan with results resolved. No treatment received for the adverse events. The outcome of the event was resolved on an unspecified date.

Other Meds:

Current Illness:

ID: 1509084
Sex: F
Age:
State: WI

Vax Date: 06/24/2021
Onset Date: 06/24/2021
Rec V Date: 07/28/2021
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Symptoms: My right arm was sore; Rubbery legs; Sinus drainage; Sore ears; Stuffy nose; Slight stomach ache; Chills; Tiredness / I was tired for about a week afterwards; Sweats; This is a spontaneous report from a contactable consumer (patient). A 43-year-old non pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection, Batch/Lot Number: EW0181), via an unspecified route of administration on 24Jun2021 08:15 (age at vaccination was 43 years) as DOSE 2, SINGLE for COVID-19 immunization at Doctor's office/urgent care. The patient's medical history was not reported. The patient had no known allergies. Concomitant medication included levocetirizine dihydrochloride (XYZAL), nicotine taken for an unspecified indication, start and stop date were not reported. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection, Batch/Lot Number: unknown), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not test COVID-19 positive prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. On 24Jun2021, by early afternoon patient's right arm was sore. At 5:00PM (by evening) the patient experienced rubbery legs, sinus drainage, sore ears, stuffy nose, slight stomachache, chills, tiredness, and sweats. Patient was tired for about a week afterwards. The events were reported as non-serious and patient was not hospitalized. The outcome of the events was recovered on an unspecified date in 2021.

Other Meds: XYZAL; nicotine

Current Illness:

ID: 1509085
Sex: F
Age:
State:

Vax Date: 04/12/2021
Onset Date: 07/05/2021
Rec V Date: 07/28/2021
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Symptoms: tested positive to COVID-19 on 05Jul2021; tested positive to COVID-19 on 05Jul2021; This is a spontaneous report from a non-contactable consumer (patient). A 39-year-old female patient received both doses of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 on 12Apr2021 (Lot Number: EW0153) and dose 1 on 16Mar2021 (Lot Number: EN6206) both intramuscular (at the age of 39-year-old) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient got COVID vaccine and tested positive to COVID-19 on 05Jul2021. The patient underwent lab tests and procedures which included SARS-CoV-2 test: positive on 05Jul2021. The patient outcome of the event was unknown. Subsequently, the complaint group via company reported that Conclusion: the complaint for Lack of Effect with the product for the COVID-19 Vaccine was investigated. The investigation included review of manufacturing records, analytical results at the time of lot release, retained reference samples, deviations, and complaint lot history trends. The final scope was limited to include the reported finished goods lot EN6206, fill lot EN5339, the bulk formulated drug product lot EN5327. No returned complaint sample was received. All deviation investigations performed during the manufacturing process of the lot were reviewed. The conclusion of all investigations confirmed there was no quality issue which would affect the quality of the lot. No root cause or CAPA were identified as the complaint was not confirmed. Subsequently, the complaint group via company reported that Conclusion: the complaint for lack of effect of the Pfizer BioNTech COVID-19 vaccine lot EW0153 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot EW0153, fill lot EP8692 and the bulk formulated drug product EW8071. A complaint sample was not returned, and photographs were not received. No related quality issues were identified during the investigation. There is no impact to product quality. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications. Subsequently, the complaint group via company reported that Conclusion: the complaint for Lack of Effect with the product for the COVID-19 Vaccine was investigated. The investigation included review of manufacturing records, analytical results at the time of lot release, retained reference samples, deviations, and complaint lot history trends. The final scope was limited to include the reported finished goods lot EN6206, fill lot EN5339, the bulk formulated drug product lot EN5327. No returned complaint sample was received. All deviation investigations performed during the manufacturing process of the lot were reviewed. The conclusion of all investigations confirmed there was no quality issue which would affect the quality of the lot. No root cause or CAPA were identified as the complaint was not confirmed. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1509086
Sex: F
Age:
State: MS

Vax Date: 07/03/2021
Onset Date: 07/03/2021
Rec V Date: 07/28/2021
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Symptoms: Sore and pin in arm of vaccination site for 7 days; Swollen lymph nodes in arm pit and neck (lymphadenopathy) under vaccination arm for more than 14 days; Sore throat; tired; Inappropriate schedule of vaccine administration; This is a spontaneous report received from a contactable consumer (patient). A 52-year-old female patient received first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- unknown) via an unspecified route of administration in left arm on 03Jul2021 at 23:30 as dose 1 single and second dose (Lot number- Pfizer Evvo198 RX5449) via an unspecified route of administration in upper left arm on 03Jul2021 as dose 2 single for COVID-19 immunization. Patient's age at vaccination was 52-year-old). Medical history included Graves' disease, allergic to peanuts, Clidomiocin. Patient previously took Tapazol, Aspartame and experienced allergy. Concomitant medications included levothyroxine sodium (SYNTHROID), amitriptyline. COVID-19 vaccine was administered at Pharmacy or Drug Store. 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. Patient was not pregnant at the time of vaccination. On 05Jul2021, patient experienced sore and pin in arm of vaccination site for 7 days, swollen lymph nodes in arm pit and neck (lymphadenopathy) under vaccination arm for more than 14 days, sore throat and tired for a week. Since the vaccination, the patient had not been tested for COVID-19. No treatment was received for the adverse events. The outcome of the events was recovering.

Other Meds: SYNTHROID; AMITRIPTYLINE

Current Illness:

ID: 1509087
Sex: F
Age:
State:

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Rec V Date: 07/28/2021
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Symptoms: bloating and feels swollen; This is a spontaneous report from a Pfizer-sponsored program COVAX US Support. A contactable female consumer reported for herself 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 an unspecified date as dose 2, single for COVID-19 immunisation. 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 unspecified date as dose 1, single for COVID-19 immunisation. It was reported that the caller received second shot and was experienced bloating and feels swollen. The outcome of the event was unknown. Information on the lot/batch number has been requested.

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Current Illness:

ID: 1509088
Sex: F
Age:
State: FL

Vax Date: 02/02/2021
Onset Date:
Rec V Date: 07/28/2021
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Symptoms: Eye issue of excessive tearing and redness; Eye issue of excessive tearing and redness; itching eyes; This is a spontaneous report from a contactable consumer (patient). A 78-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, expiry date: unknown), dose 2 via an unspecified route of administration on 02Feb2021 as dose 2, single for covid-19 immunisation. Medical history included ongoing macular degeneration. Historical vaccine of BNT162B2 for Covid-19 immunization as 12Jan2021 at the age of 78-year. Concomitant medications included varicella zoster vaccine rge (cho) (SHINGRIX). She clarified that she had regular eye care due to macular degeneration, and she also had the Shingrix vaccine in that general time period of 2 weeks between any other vaccine doses. The patient experienced eye issue of excessive tearing and redness, itching eyes in 2021. She received second dose of Pfizer Covid-19 Vaccine in Feb and this been going on since. Caller clarified that her last name was (withheld), as provided by inbound transfer agent. She clarified that she has been administered both doses of the Pfizer Covid-19 Vaccine, with her second dose being administered in Feb2021. She clarified that she has had an eye issue of excessive tearing and redness for several months that may or may not have something to do with the Pfizer Covid-19 Vaccine. She clarified that she was not sure of exactly when this event started but it was in the ballpark of after she got the second dose of the Pfizer Covid-19 Vaccine. She called to ask if there have been any reports of this effect with the Pfizer Covid-19 Vaccine. Consumer on the line who did not want to file a report, but wants to know if this has been reported before as she was experiencing red and itching eyes. She has received both doses of the Pfizer COVID-19 Vaccine. She is 78 years old and her birthday is tomorrow. She received the first dose, on 12Jan2021 and the second dose on 02Feb2021. Transfer agent stated she informed the caller this was not listed as a side effect. Transfer agent stated the caller was looking to see if anyone at all, like in the history has reported this allergy. Informed transfer agent in this department did not have anything to speak to regarding events. Transfer agent stated she tried to inform the caller of this, but she was not having that either. Therefore, was trying to transfer to safety department to see if we could help. After transfer, caller clarified event details. She stated she is having redness in the eyes and excessive tearing. She was under treatment and has macular degeneration. She goes to the specialist once a month and is seeing other specialist to determine what the issue is. She is currently using a lot of drops. She was calling because she wanted to know if this was a possible reaction to the COVID-19 Vaccine, if other people are having eye issue. She declined to continue with safety report, because she did not want to report as event because she feels it could also be a million other things. It could be her carpet or shampoo. She stated she has spoken to several different departments. At first she was speaking with a Medical department that said they do not handle COVID and then she was transferred to the Medical department that handles COVID and all they could tell her was it was not on the list of reactions. Caller stated, even though it's not listed on their list of reactions she wants to know if it has been reported at all before. She declined transfer back to Medical Information as she was told by them only have information on actual side effects. They don't know about things before it reaches a certain threshold. She stated she was informed the safety department captures the AE reports and they are the ones who could tell. After placing the caller on hold, caller then questioned about the vaccine booster. She stated she was happy to get the vaccine, she is grateful and feels that it saved her life. She wanted to know the recommendations on the booster and the projected timeline of when should get it as she is coming up on having had the vaccine for six months now and wants it before it is wore out. The outcome of events was not recovered. Information about lot/batch number has been requested.

Other Meds: SHINGRIX

Current Illness: Macular degeneration

ID: 1509089
Sex: U
Age:
State:

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Rec V Date: 07/28/2021
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Symptoms: I want to know Is my arm still suppose to be sore; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient) reported that . A patient of unspecified age had received unknown dose of bnt162b2 (BioNTech COVID-19 Vaccine RNATY, Solution for injection, Batch/Lot Number: unknown), via intramuscular on unspecified date as single dose for covid-19 immunisation. The patient medical history and concomitant medication were not reported.I just got the covid shot Monday. I want to know Is my arm still suppose to be sore. On unspecified date, the patient had experienced Pain in extremity.The following information was not provided during the call: Patient gender. Information about batch/ lot number has been requested.

Other Meds:

Current Illness:

ID: 1509090
Sex: F
Age:
State: CA

Vax Date: 07/11/2021
Onset Date: 07/13/2021
Rec V Date: 07/28/2021
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Symptoms: Rash and swelling on face, feet/toes, arms, fingers, and a little on back; Tonsils slightly swollen; Rash and swelling on face, feet/toes, arms, fingers, and a little on back; swelling on face, feet/toes, arms, fingers, and a little on back; swelling on arms, fingers; This is a spontaneous report received from a contactable consumer (patient) or other non hcp. A 15-years-old (non-pregnant) female patient received BNT162B2 (PFIZER-COVID-19 VACCINE, Batch/Lot number and Expiration date was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 11Jul2021 13:30 (at the age of 15-years-old) as dose 1, single for covid-19 immunization.Medical history included urinary tract infection from an unknown date and unknown if ongoing. Concomitant medication(s) included cefalexin taken for urinary tract infection, start and stop date were not reported.The patient previously took azithromycin for drug hypersensitivity and experienced rash, azithromycin for drug hypersensitivity and experienced swelling. On 13Jul2021 at 06:00 the patient experienced rash and swelling on face, feet/toes, arms, fingers, and a little on back, tonsils slightly swollen, joint swelling, swelling on arms, fingers. Adverse event resulted in patient visited Emergency room, department or urgent care. patient received treatment with Zyrtec.The patient did not tested for covid before and prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Device Date: 14Jul2021.The outcome of the events was recovering. Information about lot/batch number has been requested.

Other Meds: CEPHALEXINE

Current Illness:

ID: 1509091
Sex: M
Age:
State:

Vax Date: 03/18/2021
Onset Date: 03/18/2021
Rec V Date: 07/28/2021
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Symptoms: fever; Chills; headache; Body Aches; forgetting stuff worsening; This is a spontaneous report from a contactable consumer (male patient reported for himself). A 48-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot number was not reported), via an unspecified route of administration on 18Mar2021 (at the age of 48-year-old) as dose number unknown, single for COVID-19 immunization. Medical history included allergies, migraines, nerve pain, acid reflux, JC levels getting too high, ongoing pneumonia, ongoing COVID-19. The patient concomitant medications included teriflunomide (AUBAGIO), hydrocodone bitartrate, paracetamol (NORCO), gabapentin, omeprazole (PROTONIX), azelastine, fluticasone propionate (FLONASE ALLERGY RELIEF), montelukast sodium (SINGULAIR), amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), allergy shots. The patient experienced fever, chills, headache, body aches, forgetting stuff worsening on 18Mar2021. The patient underwent lab tests and procedures which included JC levels getting too high. Outcome of the events was recovered on an unspecified date in 2021. No further information was reported. Information on lot/batch number has been requested.

Other Meds: AUBAGIO; NORCO; GABAPENTIN; PROTONIX [OMEPRAZOLE]; AZELASTINE; FLONASE ALLERGY RELIEF; SINGULAIR; ADDERALL

Current Illness: COVID-19; Pneumonia

ID: 1509092
Sex: F
Age:
State: SC

Vax Date:
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Rec V Date: 07/28/2021
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Symptoms: Was out in the sun for 45 minutes burned extensively and after 3 weeks still red.; Was out in the sun for 45 minutes burned extensively and after 3 weeks still red.; Skin was scaley; This is a spontaneous report from a contactable consumer. A female patient of unspecified age received bnt162b2 (PFIZER-BIONTEC COVID-19 VACCINE, formulation: solution for injection) via unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. Medical history and Concomitant medications were not reported. It was reported that when she was out in the sun for 45 minutes burned extensively and after 3 weeks she was still red. she peeled but her skin was scaley, it was not the usual sunburn she get. The outcome of all events was unknown. Information on lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021894278 same reporter, drug and event, different patient

Other Meds:

Current Illness:

ID: 1509093
Sex: M
Age:
State: FL

Vax Date:
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Rec V Date: 07/28/2021
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Symptoms: very sick from both, 3 or 4 days he ran fevers and all; very sick from both, 3 or 4 days he ran fevers and all; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single and dose 2 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 medical history and concomitant medications were not reported. It was reported that about her son's experience with Pfizer COVID 19 vaccination, her husband got it, and had both shots, he got very sick from both, 3 or 4 days he ran fevers and all. Report declined; states he is fine. The outcome of event was Unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1509094
Sex: M
Age:
State:

Vax Date: 07/09/2021
Onset Date: 07/13/2021
Rec V Date: 07/28/2021
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Symptoms: he has these spots on his body/showed her a red spot; circular spots on the other arm and there is a deep one the one arm and in the other leg and all over the body; This is a spontaneous report from a contactable pharmacist. A 26-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), dose unknown via an unspecified route of administration on 09Jul2021 (at the age of 26 years old) (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 13Jul2021 14:00, the patient has these spots on his body. The patient came in and it looks like he has these spots on his body. He got the vaccine 09Jul2021. He showed her a red spot near where it would have been given, that looks like it is likely from it. But then there are bullet spots on the other arm and down on his foot. They almost look like targets and are pretty circular. The patient is there now. The reporter clarified the spot that she thought was where it was given was actually on his other arm. It looks like circular spots on the other arm and there is a deep one the one arm and in the other leg and all over the body. The spots first occurred not shortly after lunch time, yesterday, around 2:00PM. He had gotten the vaccine last Thursday and a few days had passed since then. Patient clarifies they were all on the arm, in both arms. The reporter considered the events as non-serious. The outcome of the events was unknown. Information regarding the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1509095
Sex: U
Age:
State:

Vax Date:
Onset Date: 07/11/2021
Rec V Date: 07/28/2021
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Symptoms: Vaccinated in Apr2021. As of now I have test positive for COVID-19 as of 11Jul2021; Vaccinated in Apr2021. As of now I have test positive for COVID-19 as of 11Jul2021; This is s spontaneous report from a contactable consumer. This consumer (patient) reported that the 27-year-old patient of an unspecified gender received first dose of bnt162b2 (BNT162B2, 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, dose 2 via an unspecified route of administration on Apr2021 (Batch/Lot number was not reported) as dose 2, single for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced vaccinated in apr2021. as of now i have test positive for covid-19 as of 11jul2021 on an unspecified date with outcome of unknown , vaccinated in apr2021. as of now i have test positive for covid-19 as of 11jul2021 on 11Jul2021 with outcome of unknown. Seriousness criteria of the events was medically significant. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 11Jul2021. The clinical course was reported as follows: I am 27 years old and was fully vaccinated in Apr2021. As of now I have test positive for COVID-19 as of 11Jul2021.I'm interested in participating for the Pfizer Booster shot. Information on the lot/batch number has been requested.

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Current Illness:

ID: 1509096
Sex: U
Age:
State: PA

Vax Date: 03/04/2021
Onset Date: 03/04/2021
Rec V Date: 07/28/2021
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Symptoms: Numbness at base of skull; Bell's Palsy; Numbness on left side of tongue, went to jaw and cheek, travelled up left side of face, to back of head at the base of the skull; This is a spontaneous report from a contactable pharmacist via medical information team. A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: EL9269), via an unspecified route of administration, administered in Arm Right on 04Mar2021 at 15:30 as a single dose for COVID-19 immunization. Medical history included osteoporosis. There were no concomitant medications. Reported that pharmacist was involved in administering the Pfizer COVID-19 vaccines at her work and due to the increase in concerns about Guillain-Barre syndrome developing with the Johnson and Johnson COVID-19 vaccine it prompted her to call Pfizer because she remembered 1 patient who was diagnosed with Guillain-Barre syndrome after receiving the second dose and she remembers 2 patients who developed Bell's Palsy after receiving their first doses of the Pfizer COVID-19 vaccines and they were not given the second doses due to these adverse events. She stated that she did report these events through the VAERS reporting system per their hospital protocol. These doses were given as outpatient. No history of previous immunization with the Pfizer vaccine considered as suspect. No additional Vaccines Administered on Same Date of the Pfizer Suspect. No prior Vaccinations within 4 weeks of vaccinations. No AE(s) following prior vaccinations. On 04Mar2021, the patient experienced bell's palsy, numbness on left side of tongue, went to jaw and cheek, travelled up left side of face, to back of head at the base of the skull, on an unspecified date in Jun2021, the patient experienced numbness at base of skull. Term highlighted by the reporter for Bell's palsy, Numbness on left side of tongue, went to jaw and cheek, travelled up left side of face, to back of head at the base of the skull, Numbness at base of skull. Relatedness of drug to reaction(s)/event(s) assessed for Bell's palsy, Numbness on left side of tongue, went to jaw and cheek, travelled up left side of face, to back of head at the base of the skull, Numbness at base of skull by method of assessment as related. All reported events were medically significant. It was reported that the patient's symptoms started around 1600-1615 on the day of their vaccine, 04Mar2021. The patient did not seek medical attention so was never formally diagnosed. Experienced numbness starting on the left side of the tongue that went up to the jaw and cheek. The numbness travelled up the left side of their face to the back of their head at the base of their skull. These symptoms lasted for about 48 hours and they were recovered completely. About a month ago, in June, the patient experienced the same kind of numbness at the base of their skull. It lasted for a couple of hours and then was gone. No AE(s) require a visit to emergency Room and physician Office. The outcome of event (Bell's Palsy, Numbness on left side of tongue, went to jaw and cheek, travelled up left side of face, to back of head at the base of the skull) was recovered on an unspecified date in Mar2021 and the outcome of event (Numbness at base of skull) was recovered on an unspecified date in Jun2021.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events Bell's palsy and Hypoaesthesia due to close temporal relationship. The case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021895191 same reporter/drug/event, different patient

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Current Illness:

ID: 1509097
Sex: U
Age:
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Symptoms: One of his friends had same side effects and all over his arms and legs.; This is a spontaneous report from a contactable consumer (patients friend). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: ER0161, Expiry date: unknown), dose number unknown via an unspecified route of administration on an unspecified date as single for covid-19 immunisation. Medical history and concomitant medications were not reported. Caller stated that, one of his friends had same side effects and rash all over his arms and legs, all over his body for the last three months and nothing is curing it and it started off on their (friends) legs as well. Reporter stated that, he will tell him about reporting, but that is up to him. Reporter declined to complete report on behalf of his friend. No further details provided. The outcome of the event of rash was not recovered at the time of this report.

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Current Illness:

ID: 1509098
Sex: U
Age:
State: CA

Vax Date: 04/09/2021
Onset Date: 04/01/2021
Rec V Date: 07/28/2021
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Symptoms: felt leg pain then disappeared day after/feel leg soreness; woke up 2-3 times per night; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiry date not reported), via an unspecified route of administration on 09Apr2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 09Apr2021 afternoon, after the first dose, the patient felt leg pain then disappeared day after. Couple days after, the patient started to feel leg soreness during nights and woke up 2-3 times per night. The patient went to check with doctor. The patient underwent lab tests and procedures which included all blood test: normal (everything was great) on an unspecified date in 2021. The leg pain continues. On 13Jul2021, the patient watched nightly news and noticed new side effects which was exactly same as the patient feeling. The outcome for the event leg pain was not recovered while it was unknown for woke up 2-3 times per night. Information about batch/lot number has been requested.

Other Meds:

Current Illness:

ID: 1509099
Sex: F
Age:
State: MA

Vax Date: 03/01/2021
Onset Date:
Rec V Date: 07/28/2021
Hospital:

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Symptoms: both forearms ache; chest felt heavy; lips swelled; eyelids drooped; hands were weaker than usual; whole right side was weak; she could not eat; could not digest food; Lost weight; she got continual heartburn and burped throughout the day after she ate; felt burning; Her stomach was knotted, she could feel her stomach closing up on her; Her stool was mush for the whole three months, it finally got to droplets that turned to mush.; it affected her digestive system and her release of the stools.; Her forehead was very much wrinkled; has a lot of food intolerances and it is not new that she is intolerant; This is a spontaneous report from a contactable consumer or other non hcp. An 80-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EN6205), via an unspecified route of administration, administered in Arm Left on 01Mar2021 (at the age of 80-years-old) as dose 2, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. She does not take pills. She takes vitamins but states that does not count. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EL9262) via unspecified route of administration, administered in Arm left on 08Feb2021, in the morning around 9:30 or 10am (at the age of 80-years-old) as dose 1, single for covid-19 immunisation. It was reported that she thinks she should report the difficulty she had with the vaccine since it was not the usual adverse reactions and it was extended. She went to doctor several times. She was wanted to know how to deal with it. Clarifies she does not have a question since this was no longer part of her system. She woke up every morning between 05:30 and 07:00 am and was awoken by both forearms aching. Then it got to where the right forearm ache was worse than the left. Sometimes she felt burning. Her chest felt heavy. Her lips swelled. Her eyelids drooped; left eyelid drooped more than the right eyelid. Her whole right side was weak. When she wrote her right hand was weaker than usual. The worst reaction was that she could not eat, she could not digest food, her digestion was completely off. When she went to doctor, she weighed 92 pounds since she got continual heartburn and burped throughout the day after she ate, and this continued for hours. She had to make special food for herself since she could not digest/ eat most food. She ate fish, bread, and potato. She could not digest anything heavy. Her stomach was knotted, she could feel her stomach closing up on her. She was fearful of eating. Her stool was mush for the whole three months, it finally got to droplets that turned to mush. The main thing as she said, it affected her digestive system and her release of the stools. She lost 8 to 10 pounds. She kept a diary of her food and feelings for months. Her forehead was very much wrinkled, she has wrinkles anyways since she was old, but she had wrinkles in her wrinkles. She had a lot of food intolerances and it was not new that she was intolerant. Her body had many intolerances such chocolate, lactose, nuts, and some medications. She cannot eat anything with any chemicals such as msg and yellow food dye. She cannot eat deli meat since it contains some chemical. At first, she didn't realize it and did not know what was going on with her body, she noticed the side effects mentioned above more after the second dose which was given on 01Mar2021. It took three and half months and finally went it all went away, recovered completely. The patient was recovered from all the events on an unspecified date. No follow-up attempts required. No further information expected.

Other Meds:

Current Illness:

ID: 1509100
Sex: M
Age:
State: PA

Vax Date:
Onset Date:
Rec V Date: 07/28/2021
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Symptoms: has no immunity after his Pfizer COVID vaccine; This is a spontaneous report from a Pfizer sponsored program from a contactable consumer. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number and expiry date was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient has no immunity after his pfizer covid vaccine on an unspecified date. The outcome of event was unknown. Information on Lot/Batch number has been requested.

Other Meds:

Current Illness:

ID: 1509101
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 07/28/2021
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Symptoms: had more or less the same reaction that the caller had, Her lips felt swollen and they were tingling, she had a taste like lead or metal in her mouth, she was not feeling well and she had disgusting diarrhea, it was black and horrible; had more or less the same reaction that the caller had, Her lips felt swollen and they were tingling, she had a taste like lead or metal in her mouth, she was not feeling well and she had disgusting diarrhea, it was black and horrible; had more or less the same reaction that the caller had, Her lips felt swollen and they were tingling, she had a taste like lead or metal in her mouth, she was not feeling well and she had disgusting diarrhea, it was black and horrible; had more or less the same reaction that the caller had, Her lips felt swollen and they were tingling, she had a taste like lead or metal in her mouth, she was not feeling well and she had disgusting diarrhea, it was black and horrible; had more or less the same reaction that the caller had, Her lips felt swollen and they were tingling, she had a taste like lead or metal in her mouth, she was not feeling well and she had disgusting diarrhea, it was black and horrible; had more or less the same reaction that the caller had, Her lips felt swollen and they were tingling, she had a taste like lead or metal in her mouth, she was not feeling well and she had disgusting diarrhea, it was black and horrible; This is a spontaneous report from a contactable consumer (friend's wife). This consumer reported similar event for 2 patients. This is the second report. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiry date not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient had more or less the same reaction that the caller had, her lips felt swollen and they were tingling, she had a taste like lead or metal in her mouth, she was not feeling well and she had disgusting diarrhea, it was black and horrible. The outcome for the events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021894470 same reporter/drug, different patient/AE

Other Meds:

Current Illness:

ID: 1509102
Sex: F
Age:
State: TX

Vax Date: 07/08/2021
Onset Date: 07/11/2021
Rec V Date: 07/28/2021
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Symptoms: tired; fever; bodyaches; headaches; tingling and burning on both feet, knees, on the arms, elbows and hands (for both arms); tingling and burning on both feet, knees, on the arms, elbows and hands (for both arms); This is a spontaneous report from a contactable consumer or other non hcp(patient). A 62-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EW0191), via an unspecified route of administration, administered in arm left on 08Jul2021 (at the age of 62-year-old) as single dose for COVID-19 immunisation. Medical history included, fibromyalgia, arthritis, irritable bowel syndrome, intervertebral disc degeneration, spinal stenosis, intervertebral disc protrusion, pain does not take anything for it, just drinks a lot of water, and tries to walk around and stretch. Concomitant medications included latanoprost (0.005% ophthalmic solution, instill one drop into both eyes at bedtime; Bottle says 125mcg/2.5ml) taken for glaucoma; ascorbic acid (VITAMIN C ACID) 500 mg; ascorbic acid, bioflavonoids NOS (ESTER C + BIOFLAVONOIDS) 1x/day (500mg vegetarian capsule, usually takes one a day); colecalciferol (VITAMIN D [COLECALCIFEROL]). The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: unknown), via an unspecified route of administration, administered on 17Jun2021 (at the age of 62-year-old) as single dose for COVID-19 immunisation. On an unspecified date, the patient experienced tired. On 11Jul2021, the patient experienced tingling and burning on both feet, knees, on the arms, elbows and hands. On 12Jul2021 11:00, the patient experienced fever, bodyaches, headaches, tingling and burning on both feet, knees, on the arms, elbows and hands. Reporter is a 62-year-old, female who had both doses of the PFIZER-BIONTECH COVID-19 VACCINE. She has no significant side effect after getting her 1st dose. However, after getting her 2nd dose on 08Jul2021, the Reporter experienced fever, bodyaches, headaches and on 12Jul2021 had experienced tingling and burning on both feet, knees, on the arms, elbows and hands (for both arms). She mentioned that it is tolerable but still keeps her up at night. Caller added that she has autoimmune response and had some inflammatory diseases. Caller also mentioned that she took Tylenol 500 mg for her fever, bodyaches and headaches and was resolved immediately on Saturday/Sunday. In line with this, caller would like to know if she can take ibuprofen for the tingling and burning sensations. The patient underwent lab tests and procedures which included body temperature: 100. Therapeutic measures were taken as result of fever (pyrexia), bodyaches (pain), headaches (headache). The outcome of the events fever, bodyaches, headaches was recovered on unknown date in 2021. The outcome of the events tingling and burning on both feet, knees, on the arms, elbows and hands was unknown. No follow-up attempts are possible. No further information is expected.

Other Meds: LATANOPROST; VITAMIN C ACID; ESTER C + BIOFLAVONOIDS; VITAMIN D [COLECALCIFEROL]

Current Illness:

ID: 1509103
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 07/28/2021
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Symptoms: vertigo since receiving both doses of the vaccine; This is a spontaneous report from a contactable consumer (reporter's friend). A 76-year-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unknown date, as dose 1 and dose 2, single for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unknown date, the patient experienced vertigo since receiving both doses of the vaccine. The outcome of the event was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1509104
Sex: M
Age:
State: CA

Vax Date: 07/12/2021
Onset Date:
Rec V Date: 07/28/2021
Hospital:

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Symptoms: Rash on skin, face, mouth, legs; This is a spontaneous report from a contactable consumer (patient) or other non health care professional. A 21-years-old male patient received bnt162b2 (Covid-19 vaccine, Formulation: Solution for injection), via an unspecified route of administration on 12Jul2021 as dose 2, single for covid-19 immunisation The patient medical history and concomitant medications were not reported. The patient previously received BNT162B2 for Covid-19 immunization (Dose 1). On an unspecified date, the patient experienced rash on skin, face, mouth, legs. Treatment received for the adverse events. The outcome of the event was unknown. Information about batch/ lot number has been requested.

Other Meds:

Current Illness:

ID: 1509105
Sex: F
Age:
State: NJ

Vax Date: 04/09/2021
Onset Date: 04/12/2021
Rec V Date: 07/28/2021
Hospital: Y

Vax Type:
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Symptoms: pneumothorax, her right lung collapsed; cyst that was ready to burst on her lung; swelling in her right arm under the arm and in her chest area and breast; swelling in her right arm under the arm and in her chest area and breast; a heart murmur; a high resting heart rate; Back pain; lymph node swelling under her right arm pit into her chest; swelling in her lymph nodes and in her chest that were painful; swelling in her right arm under the arm and in her chest area and breast; This is a spontaneous report from a contactable consumer (patient's mother). A 21-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 09Apr2021 (lot number EW0153), at the age of 21 years, as the first single dose, for COVID-19 immunisation. Medical history was not reported. Concomitant medication included an unspecfied low estrogen birth control (she just took a birth control pill every day, probably on it since she was 16 or 17 years old). On 12Apr2021 the patient experienced back pain. On an unspecified date in 2021 the patient experienced lymph node swelling under her right arm pit into her chest. She had swelling in her lymph nodes and in her chest that were painful and she could touch them. On 16Apr2021 the patient experienced pneumothorax (on that day she went to the urgent care and they told her that her lung was about to collapse). The reporter finally got her daughter to come home from school and she took her to the emergency room on 17Apr2021. When the lung had collapsed, she felt worse and then she was in the hospital for an entire week. This event required hospitalization from 17Apr2021 to 29Apr2021. On 23Apr2021 she had a tube in her chest that was drawing the air out and they did something where they inflated her lung to see if it would stay and it wouldn't stay so they had to do surgery on 26Apr2021. When they went to do surgery they saw that on the outer part of her lung where the hole was that it wouldn't heal and they saw that it was like a cobble stone texture on the outside of the lung. The patient was in the hospital until 29Apr2021 and she was in the ICU the entire time. She went for check-ups and everything seemed to be good and her lung had healed. The caller was trying to connect dots between her family members and she had asked her daughter how she felt right after the COVID vaccine and her daughter said that she felt like "ehhh" and then on 12Apr2021 she had the back pain, then on 13Apr2021 she had air bubbles in her chest and on 15Apr2021 she was trying to walk to bars and she was out of breath. On 16Apr2021 the urgent care said they saw a cyst that was ready to burst on her lung and she was on bed rest and was given steroids. The caller thought that the swelling and the lymph nodes and having the cobble stone texture were all from irritation and then it had made a blister that popped creating the hole. On 29Jun2021 the patient experienced heart murmur and a high resting heart rate. Around 29Jun2021, the patient was feeling like her heart was moving in her chest and that it was out of synch and not right and that it was racing high and so the reporter called their family doctor who saw the patient the next day. They did an EKG that was irregular and now she had a heart murmur. She wasn't born with that and she had never had that and she didn't leave the hospital with that. She was fine until now with her having the murmur and the high resting heart rate, around 85. The caller didn't know the exact EKG irregularities because it said "normal" but they gave a copy to her and said to bring it to the cardiologist because it was not normal. The reporter didn't know the details and won't until the follow-up appointment on 16Jul2021 which was when they would have a better idea about what they were going to call this. She had the swelling in her right arm under the arm and in her chest area and breast, she was thin breasted, this was on the right side and then her right lung collapsed. The caller says that this was not a coincidence. There was no way that she would have three family members injured if it wasn't for the COVID vaccine. Her daughter should be taking an allergy medication but she won't take it. The patient did not receive the 2nd dose (when she had gotten out of the hospital after her pneumothorax that was when she was supposed to get her 2nd dose but they didn't go get it because they couldn't risk that). Back pain resolved on an unspecified date in 2021. The other events outcome was unknown. Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : PFIZER INC-2021899289 same reporter/product/patient, different dose/event

Other Meds:

Current Illness:

ID: 1509106
Sex: F
Age:
State:

Vax Date: 07/14/2021
Onset Date: 07/14/2021
Rec V Date: 07/28/2021
Hospital:

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Symptoms: Asthma; This is a spontaneous report from a contactable consumer (mother). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number and expiry date not reported), via an unspecified route of administration on 14Jul2021 (also reported as in this morning) as dose number unknown, single for COVID-19 immunisation. Medical history included asthma. Concomitant medication included salbutamol (SALBUTAMOL) taken for asthma. The patient experienced asthma on 14Jul2021. The reporter was asking if the patient can use her Ventolin inhaler as she experienced asthma. The outcome for the event was unknown. Information on lot/batch number has been requested.

Other Meds: SALBUTAMOL

Current Illness:

ID: 1509107
Sex: F
Age:
State: NJ

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

Vax Type:
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Symptoms: Right and left feet had went numb; This is a spontaneous report from a contactable consumer. This consumer reported for a patient that: An unspecified age of female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date reported, Solution for injection), via an unspecified route of administration, administered on an unspecified date, as an unknown, single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced a right and left feet had went numb. Within the original report the caller mentioned that when her daughter was sitting in the chair after the COVID vaccine that her right and left feet had went numb. She said that this same side effect also happened to her friend (withheld). The event accessed as a non serious. The outcome of event is unknown. Probed if caller wanted to complete a safety report for the individual mentioned and she declined and said that she cannot speak on their behalf. Information about lot/batch number is requested.

Other Meds:

Current Illness:

ID: 1509108
Sex: F
Age:
State: NJ

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

Vax Type:
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Symptoms: Hers are hot and painful; Hers are hot and painful; her feet and ankles down were bright red they got hotter and redder; This is a spontaneous report from a contactable consumer. This consumer reported for a female patient (reporter's friend) of unspecified age that received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot: UNKNOWN) via an unspecified route as a single dose on an unspecified date for COVID-19 immunization. Medical history and concomitant medications were not reported. It was reported that the patient developed 'COVID toes' on unspecified date. Hers (toes) were hot and painful, so hot that you could fry an egg on them. She sat in the sun for maybe 15 minutes and her feet and ankles down were bright red. They got hotter and redder and it was so uncomfortable that she had to go to her doctor who had called it COVID toes phenomenon. She had to get a topical steroid and go back to the doctor's again for her feet. The outcome of the events was unknown.

Other Meds:

Current Illness:

ID: 1509109
Sex: M
Age:
State: NJ

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

Vax Type:
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Symptoms: Hashimoto's disease; Painful, cold, purple feet; Painful, cold, purple feet; Painful, cold, purple feet; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received the 2nd dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration, on an unspecified date (Batch/Lot number was not reported), as single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced Hashimoto's disease (medically significant) on an unspecified date with outcome of unknown and painful, cold, purple feet (non-serious) on an unspecified date with outcome of unknown. The lot number for the vaccine, bnt162b2, was not provided and will be requested during follow-up.

Other Meds:

Current Illness:

ID: 1509110
Sex: M
Age:
State: NJ

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

Vax Type:
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Symptoms: COVID toes; This is a spontaneous report from a contactable consumer or other non hcp. A male patient (caller's friend's husband) of an unspecified age received BNT162B2, Solution for injection, Batch/Lot number was not reported, Expiry date was not provided) via an unspecified route of administration on an unspecified date (at an unspecified age) as dose number unknown, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date he patient experienced covid toes. Additional information: Within the original report the caller was following up on two previous reports that she had made for side effects from the COVID vaccine. Within the original report the caller mentioned that her friend's husband had the same kind of side effects with the COVID toes and he said that the good news is that the vaccine was rolled out early but the bad news is also that the vaccine was rolled out early. Reporter seriousness for COVID toes was reported as unspecified. Investigation Assessment was not provided. The outcome of the event was unknown. Additional Context: The report is cross referenced to report ID: 6L9I1WGJ Information about lot/Batch number has been requested.

Other Meds:

Current Illness:

ID: 1509111
Sex: F
Age:
State: MO

Vax Date: 07/12/2021
Onset Date: 07/13/2021
Rec V Date: 07/28/2021
Hospital:

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Symptoms: Left underarm and left breast pain; Left underarm and left breast pain; This is a spontaneous report from a contactable other hcp (patient). A 59-year-old non-pregnant female patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Lot number: Fa6780), via an unspecified route of administration, administered in Arm Left on 12Jul2021 16:30 as DOSE 1, SINGLE for covid-19 immunisation. Medical history included hypertension and Penicillin allergy. Prior to vaccination patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. patient received within 2 weeks of vaccination: Blood pressure meds. The patient experienced left underarm and left breast pain on 13Jul2021. The outcome of the events was not recovered.

Other Meds:

Current Illness:

ID: 1509112
Sex: F
Age:
State: IN

Vax Date: 06/22/2021
Onset Date:
Rec V Date: 07/28/2021
Hospital:

Vax Type:
Manufacturer:
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Symptoms: My front left tooth and two bottom teeth have been demineralizing and you can see through them now.; I have bone pain in my pelvic bone.; This is a spontaneous report received from contactable consumer (pharmacist reported for herself). A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0180; Expiration Date: Aug2021), via an unspecified route of administration on 22Jun2021 at 12:00 (at the age of 41-year-old), as dose 1, single; and received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EY0584, Expiration Date: Oct2021), via an unspecified route of administration on 14Jul2021 at 12:00, (at the age of 41-year-old), as dose 2, single in left arm for COVID-19 immunization at Pharmacy/drug store. The patient's medical history included multiple sclerosis, and ulcerative colitis. Concomitant medications included natalizumab (TYSABRI) taken for multiple sclerosis, start and stop date were not reported. The patient did not receive any other vaccines within four weeks prior to Covid19 vaccine. The pharmacist reported that she had an adverse drug reaction, that has been occurring since her first COVID vaccine and she got her second COVID vaccine on 14Jul2021 and it was more pounced since that point of time. On an unspecified date, the patient's front left tooth and two bottom teeth had been demineralized and could see through them now and had bone pain in her pelvic bone. The events were persistent. It was progressively getting worst. Patient had appointment with her doctor and took blood test. Patient tried her pain medication that she had for Ulcerative colitis and had Tylenol. The patient bought toothpaste and mouth wash that contain high concentration of fluoride. The patient underwent lab tests and procedures which included blood test: unknown, on an unspecified date. The clinical outcome of the events was unknown.

Other Meds: TYSABRI

Current Illness:

ID: 1509113
Sex: U
Age:
State: FL

Vax Date: 03/01/2021
Onset Date:
Rec V Date: 07/28/2021
Hospital:

Vax Type:
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Vax Name:
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Symptoms: have now leg//knee problems; have now leg//knee problems.knee pain; drag right leg in home, and they fell like rubber as hard standing; in bed is worse as hard to get into position to get asleep; This is a spontaneous report from a contactable consumer (Patient). A 82-years-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection), dose 2 via an unspecified route of administration on an unspecified date in Mar2021 (Batch/Lot number was not reported) as dose 2, single and dose 1 via an unspecified route of administration on an unspecified date in Feb2021 (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in 2021, patient have leg, knee problems. Some times patient drag right leg in home, and they felt like rubber as hard standing. In bed it was worse as hard to get into position to get asleep for knee pain. Patient can not see a doctor as they only will talk on phone so this is hard. The outcome of events was unknown. Information about lot/batch number is requested.

Other Meds:

Current Illness:

ID: 1509114
Sex: U
Age:
State: MI

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

Vax Type:
Manufacturer:
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Symptoms: lupus and Sjogren syndrome; lupus and Sjogren syndrome; This is a spontaneous report from a contactable consumer (patient), reported to the Pfizer Clinical Trials Contact Center. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown), via unspecified route of administration, on an unspecified date in 2021, as dose 1 and dose 2, single (both the doses) for COVID-19 immunisation. Medical history included immunosuppressed system. Concomitant medications included unspecified immuno-suppressant medication. The patient received both Pfizer Covid vaccine shots in 2021. On an unspecified date in 2021, the patient experienced lupus and Sjogren's syndrome. The events were serious (medically significant). The patient underwent lab test which included Antibodies test: unknown results (still do not have any antibodies). The outcome of the events was unknown. Information on lot/batch number has been requested.

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ID: 1509115
Sex: F
Age:
State: FL

Vax Date: 06/24/2021
Onset Date: 06/01/2021
Rec V Date: 07/28/2021
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Symptoms: Rash starting on her face down to her chest and its getting worse; This is a spontaneous report from a Pfizer sponsored program COVAX US support. A contactable female consumer reported for herself that a patient of an unspecified age received bnt162b2 (Pfizer Covid-19 Vaccine; formulation: solution for injection), dose 2 via an unspecified route of administration on 24Jun2021 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient historical vaccine included BNT162B2 1st dose for covid-19 immunization and no events were reported for 1st dose. The patient reported in Jun2021 that 2 weeks after her 2nd dose (24Jun) she experienced rash and it got worse. Rash starting on her face down to her chest. Patient was unable to remember her 1st dose schedule. She was asking what to do. The outcome of the event was unknown. Information about batch/ lot number has been requested.

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Current Illness:

ID: 1509116
Sex: F
Age:
State: LA

Vax Date: 07/13/2021
Onset Date: 07/01/2021
Rec V Date: 07/28/2021
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Symptoms: Itching all over and hurting, I have sore throat.; Itching all over and hurting, I have sore throat.; have not slept, it kept me over night long; Itching and my face is red and hot hot but I am cold, covered with three blankets and I have chills, sore throat, but I do not have fever; my face is red and hot hot; It just started hurting little bit; Itching and my face is red and hot hot but I am cold, covered with three blankets and I have chills, sore throat, but I do not have fever.; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: ER8733), via an unspecified route of administration on 13Jul2021 (at the age of 66-year-old), as dose 1, single for COVID-19 Immunization. Medical history included 14 back surgeries, had 2 shoulder surgery, had 1 hand surgery and 1 hip surgery. Concomitant medications included 13 unspecified medications (also reported as: take lot of medication, yes. Kidney). Consumer stated that she took the shot yesterday and last time she was okay. On an unknown date in Jul2021, just started hurting little bit, have not slept, it kept her over night long. On 13Jul2021 either between 8 and 10 clock, started itching all over and hurting. She had sore throat, itching all over and her face was red and hot but she was cold, covered with three blankets and she have chills, hurting and they told her that she will hurt but she do not have fever. Consumer stated that she had an appointment on 03Aug2021 for 2nd dose. Consumer stated lab test was not done, and she have to go for lab test. Regarding treatment consumer stated that she does not know what to do. The outcome of the event pruritus was not recovered. The outcome of the remaining events was unknown.

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Current Illness:

ID: 1509117
Sex: U
Age:
State:

Vax Date: 07/11/2021
Onset Date: 07/01/2021
Rec V Date: 07/28/2021
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Symptoms: Developing a skin rash; it spread all over my body; Allergic reaction; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number was not reported), via an unspecified route of administration on 11Jul2021 12:15 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number was not reported), via an unspecified route of administration on 20Jun2021 as dose 1, single for covid-19 immunisation. The patient received the second dose of the vaccine on Sunday afternoon and developed a skin rash (on Jul2021). The patient was not sure if it was from the vaccine or not, but it spread all over the body and patient was little bit concerned. The patient does not know if that vaccine was good, it does give an allergic reaction or something in the vaccine (Further clarification was unknown) that was not sure of. The outcome of the events was unknown. Information on the lot/batch number has been requested.

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Current Illness:

ID: 1509118
Sex: F
Age:
State: TX

Vax Date: 12/01/2020
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Rec V Date: 07/28/2021
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Symptoms: She received the 1st dose of the Pfizer-BioNTech Covid-19 Vaccine back in December. Then a week after, she was diagnosed with Covid-19.; This is a spontaneous report from a contactable consumer via Pfizer sponsored program COVAX US Support. A 64-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection), via an unspecified route of administration on Dec2020 (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient received the 1st dose of the Pfizer-BioNTech COVID-19 Vaccine back in December. Then a week after, she was diagnosed with COVID-19. Due to this, instead of receiving the 2nd dose 3 weeks after, she received it 6 months after the 1st dose. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on an unspecified date. The outcome of the event was unknown. Information on the lot/ batch number has been requested.

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Current Illness:

ID: 1509119
Sex: F
Age:
State: VA

Vax Date: 07/13/2021
Onset Date: 07/01/2021
Rec V Date: 07/28/2021
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Symptoms: Runny nose; Coughing; her throat is irritated/scratchy; feels like she flu like symptoms; feels like she is getting a cold; 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, Formulation: Solution for injection, Lot Number and Expiration Date: unknown), via an unknown route of administration on 13Jul2021 as dose 1, single for covid-19 immunization. Medical history included diabetes and hypertension. The patient's concomitant medication included unspecified medication for her high blood pressure. The patient reported that, she took the shot on Tuesday 13Jul2021 and yesterday (as reported) on an unknown date in Jul2021 she started having a runny nose and has been coughing. She was not really sick. Her nose has been running a lot and she was coughing a lot. She feels like her throat is irritated/ scratchy and flu-like symptoms. On an unknown date in Jul2021, she felt like she is getting a cold. Outcome of events was unknown. Information on the lot/batch number has been requested.

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Current Illness:

ID: 1509171
Sex: U
Age:
State: TX

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Rec V Date: 07/28/2021
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Symptoms: fainting episodes; This spontaneous report was received from a registered nurse via a sales representative and refers to a 9-year-old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date in 2021 (reported as in the past 4 to 6 months), the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) injection, 0.5 milliliter, intramuscularly (injection site, lot # and expiration date were not provided) for prophylaxis. On the same date right after the injection, the patient experienced fainting episode. The patient was kept in the clinic for a while, recovered, and was sent home. It was reported the patient sought medical attention but it was unknown if any treatment was given. The relatedness between the event and the suspect vaccine was not provided. Upon internal review, the event of fainting episode was considered to be medically significant. This is one of three reports received from the same reporter.; Sender's Comments: US-009507513-2107USA007327: US-009507513-2107USA007555:

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Current Illness:

ID: 1509172
Sex: U
Age:
State: TX

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Rec V Date: 07/28/2021
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Symptoms: fainting episodes; This spontaneous report was received from a registered nurse via a company representative and refers to a 9-year-old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date in 2021 (reported as in the past 4 to 6 months), the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) injection, 0.5 milliliter, intramuscularly (injection site, lot # and expiration date were not provided) for prophylaxis. On the same date right after the injection, the patient experienced fainting episode. The patient was kept in the clinic for a while, recovered, and was sent home. It was reported the patient sought medical attention but it was unknown if any treatment was given. The relatedness between the event and the suspect vaccine was not provided. Upon internal review, the event of fainting episode was considered to be medically significant. This is one of three reports received from the same reporter.; Sender's Comments: US-009507513-2107USA007327: US-009507513-2107USA007519:

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Current Illness:

Total 2021 VAERS Injuries: 704,237

Page last modified: 03 October 2021 5:28pm