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
187,133MODERNA
33,878JANSSEN
2,321PFIZER\BIONTECH
1,091GLAXOSMITHKLINE BIOLOGICALS
983UNKNOWN MANUFACTURER
363MERCK & CO. INC.
229SEQIRUS, INC.
45DYNAVAX TECHNOLOGIES CORPORATION
41NOVARTIS VACCINES AND DIAGNOSTICS
29SANOFI PASTEUR
18EMERGENT BIOSOLUTIONS
8PAXVAX
7TEVA PHARMACEUTICALS
4PFIZER\WYETH
3BERNA BIOTECH, LTD.
2SMITHKLINE BEECHAM
2INTERCELL AG
2PROTEIN SCIENCES CORPORATION
1CSL LIMITED

Incidents per State

State Total
77,548
AK1,869
AL5,581
AR3,688
AS47
AZ14,288
CA61,984
CO11,665
CT8,149
DC1,663
DE1,807
FL37,749
FM5
GA15,058
GU120
HI2,453
IA4,625
ID2,692
IL20,334
IN24,007
KS4,615
KY7,696
LA4,887
MA14,654
MD12,514
ME3,129
MH11
MI18,739
MN12,528
MO9,710
MP29
MS2,790
MT2,375
NC16,368
ND1,356
NE2,880
NH3,100
NJ17,634
NM3,916
NV4,239
NY34,355
OH19,081
OK6,195
OR8,636
PA23,083
PR2,370
QM2
RI2,088
SC6,411
SD1,212
TN9,131
TX35,174
UT4,273
VA14,937
VI64
VT1,676
WA14,909
WI11,259
WV2,388
WY861
XB5
XL1
XV2

ID: 1405560
Sex: M
Age:
State: PA

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

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 037K20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Dysphagia, Epiglottitis

Symptoms: Exposed to covid virus; This is a spontaneous report from a Pfizer-sponsored program via medical information team. A contactable male consumer reported that a male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, batch/lot number: unknown) via an unspecified route of administration on an unspecified date as 1st dose, single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Caller would like to know if he can get the 2nd dose of the vaccine tomorrow 28Mar2021 or should be rescheduled as he was exposed with the virus, he lives in the same house with his daughter. Also, on 26Mar2021, he was tested but he did not get the results yet so he was confused if he needs to take the 2nd dose or should push a week more. Caller added that he will get his result for his covid test today. His daughter was tested on Wednesday 24Mar2021 and the result came on 26Mar2021 positive, already got the 2 doses of the vaccine, the second dose was 11Feb2021 and the 1st dose was 3 weeks before the 2nd dose. Already spoke to his health care professional and advised him to cancel his second dose and reschedule it the next week. Outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1405561
Sex: F
Age:
State:

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

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025L20A
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Anxiety, Dyspnoea

Symptoms: migraine; This is a spontaneous report received by Pfizer from the company (Case ID: GI-2021-2655). A contactable consumer reported for a female patient (wife) who received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 2ND DOSE, SINGLE for covid-19 immunisation; eletriptan hbr (RELPAX), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication . The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced migraine (non-serious) on an unspecified date with outcome of unknown. The action taken in response to the event( for eletriptan hbr was unknown. No follow-up attempts are Possible. Information on lot/batch cannot be obtained.

Other Meds:

Current Illness:

ID: 1405562
Sex: M
Age:
State: PA

Vax Date: 03/22/2021
Onset Date: 03/24/2021
Rec V Date: 06/17/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot: EL1284
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Chest discomfort, Dysphagia, Pain in extremity, Visual impairment

Symptoms: Tested positive for COVID-19; This is a spontaneous report from a contactable consumer (patient) via the Health Authority. A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 22Mar2021 as a 1st dose, single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient reported that, he received Pfizer COVID-19 vaccine (this past Monday) on 22Mar2021, and later tested positive for COVID-19 on (Wednesday) 24Mar21, which means he likely had COVID when he received the vaccine. On 24Mar2021, the patient underwent lab test and procedure included SARS-CoV-2 test: Covid positive. Given that you are not supposed to receive the vaccine until 90 days after being infected. He wanted to know if there was anything he should do. He appeared to be asymptomatic. He also wanted to know if he should receive the second dose of the vaccine (He scheduled to receive it on Monday, 12Apr2021). The outcome of the event was unknown. No follow up attempts are possible. Information about Lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1405563
Sex: F
Age:
State: MN

Vax Date: 03/13/2021
Onset Date:
Rec V Date: 06/17/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: unknown
Dose Series: UNK
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: Cold sore; Developed cold sore above lip after receiving vaccine.; This is a spontaneous report from a contactable consumer (patient, self-reported). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on 13Mar2021, as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that she received her first dose on 13Mar2021 and was scheduled on 04Apr2021 for the second dose. As per the patient, the cold sore started a few days ago, around the 24Mar2021. The patient developed cold sore above lip after receiving vaccine. The patient asked she had a cold sore, could she get the second dose. The patient calling about the Pfizer COVID-19 vaccine who says she had a question about getting her second shot that she was supposed to get Saturday because she had a cold sore, and she was wondering if that means she could not get her second dose of the vaccine. Outcome of the events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1405564
Sex: M
Age:
State:

Vax Date: 03/14/2021
Onset Date: 03/19/2021
Rec V Date: 06/17/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth

Symptoms: positive for covid; This is a spontaneous report from a contactable consumer or other non hcp.A 19-year-male patient received first dose of bnt162b2 (BNT162B2,PFIZER-BIONTECH COVID-19 Vaccine,Batch/Lot number and Expiry date: not reported), via an unspecified route of administration on 14Mar2021 as 1ST Dose, Single Dose for covid-19 immunisation.The patient medical history and concomitant medications were not reported.The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 19Mar2021.On 19Mar2021 the patient experienced positive for covid sars-cov-2 test positive. patient stated that he had received his first dose on14Mar2021and was tested sars-cov-2 test positive on 19Mar2021 he came out of quarantine on an unspecified date. The patient stated that his second dose was scheduled on 10Apr2021,he wanted to know whether he could receive the second dose or not.The outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot been obtained.

Other Meds:

Current Illness:

ID: 1405565
Sex: F
Age:
State: TN

Vax Date: 03/26/2021
Onset Date: 03/01/2021
Rec V Date: 06/17/2021
Hospital:

Vax Type: FLUC4
Manufacturer: SEQIRUS, INC.
Vax Name: INFLUENZA (SEASONAL) (FLUCELVAX QUADRIVALENT)
Lot: 276563
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Chills, Confusional state, Eye inflammation, Headache, Laboratory test

Symptoms: Woke up three or four different times with cold sweats- soaking wet and got really cold; Woke up three or four different times with cold sweats- soaking wet and got really cold; She couldn't make it to work today; She was soaked and got really cold.; Vomitting; She didn't eat anything all day Saturday and she was only able to eat half a banana on Sunday; Nausea; She was hot; Mild fever; Bad headache; Weakness; She started feeling sick; She hasn't been feeling good; Muscle soreness- hurting all over; Tiredness; Felt like she was getting the covid again; Her body was sore and she was hurting all over; Migraines; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL 1406), via an unspecified route of administration on 26Mar2021 at 11:30AM as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Patient was wondering if what she's experiencing was normal, she hasn't been feeling good since vaccination, she couldn't make it to work today. She felt like getting covid again in December, she didn't know if that was normal or not, she had covid and was in the hospital for it for five and a half days. She clarifies she started feeling sick later that night at about 11:30-12:00 AM, she first woke up with a real bad headache and then she got nauseous and felt sick. she didn't eat anything all day Saturday and she was only able to eat half a banana on Sunday. She confirms she hasn't been nauseas since Sunday morning. On 27Mar2021 experienced vomiting around 1-1:30 AM that stopped about 4-5 am on 27Mar2021. Caller mentions that with the mild fever, this morning she woke up three or four different times with cold sweats. Caller states she doesn't know if it was her fever breaking, but she was soaking wet. Caller clarifies that this was different from night sweats because she was soaked and got really cold. Caller reports she suffers from migraines, she took her migraine medicine, but it didn't help- it didn't make the headache go away. Caller clarifies she is taking Imitrex, but doesn't know the exact dosage. She can take no more than two within a 24 hour period. She doesn't have her pill bottle handy. She explains everything started the symptoms hit her all at the same time that Friday night around 11pm-12am. She was nauseas, headachy, she was hot, running a mild fever, she was weak. It woke her up. Caller states that she feels like she is getting better, most of the muscle soreness is gone. Her body was sore and she was hurting all over, but that's pretty much gone. Caller declines to continue with the report, stating she is really tired and the questions are getting to her and just wearing her out. She had 1st this Friday 26Mar2021 11:30AM, then during that night she experienced the side effects like nausea, headache and fever. Caller is feeling a little better now. Asking if those side effects are normal. Patient wanted to know if the second dose was worse than the first dose for side effects. Patient wanted to know if the People who had covid and received the vaccine then the people who did not have covid and received the vaccine have worse side effects, is that true. As response referred the patient to the doctor. Caller reports her doctor knows about her having covid and being in the hospital. Treatment received included they were giving her antibodies, antivirals, migraine medicine. outcome of Nausea, Vomiting , Muscle soreness was recovered for Headache, Weakness and Tiredness was not recovered for General body pain, Fever was recovering for Migraines was not recovered and for rest of the events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1405566
Sex: F
Age:
State: AL

Vax Date: 03/15/2021
Onset Date: 03/24/2021
Rec V Date: 06/17/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Pyrexia, White blood cell count decreased

Symptoms: Received first dose of Covid-19 vaccine and tested positive for Covid; This is a spontaneous report from a contactable consumer (patient herself). A 30-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6205) via an unspecified route of administration on 15Mar2021 as 1ST DOSE, SINGLE DOSE for covid-19 immunisation. The patient's medical history was none, and concomitant medications were not reported. On 24Mar2021, the patient tested positive for covid (sars-cov-2 test positive). The patient was scheduled to get the second dose three weeks later 05Apr2021. The patient wanted to know if it is still ok to get the second dose of the vaccine even after tested positive for Covid. The outcome of the event was unknown. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1405567
Sex: F
Age:
State:

Vax Date: 03/23/2021
Onset Date: 03/28/2021
Rec V Date: 06/17/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: UNK
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Pharyngeal swelling

Symptoms: diagnosed with COVID; This is a spontaneous report from a contactable consumer (wife) or other non hcp. A 70-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 23Mar2021 as 1st dose, single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On 28Mar2021, Yesterday, the patient was diagnosed with COVID-19. The patient had felt terrible and had fevers and these are the symptoms of COVID-19. The patient was scheduled to second dose on 13Apr2021. The patient wants to know how long they (patient and her husband) should wait to get the second vaccine, considering their COVID diagnosis. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch cannot be obtained.

Other Meds:

Current Illness:

ID: 1405568
Sex: M
Age:
State: OH

Vax Date: 03/17/2021
Onset Date: 03/27/2021
Rec V Date: 06/17/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Abdominal pain, Chills, Sleep disorder

Symptoms: 27Mar2021, he tested positive for 2 covid test; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 56-years-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 17Mar2021 (at the age of 56-years-old) as 1st dose, single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient stated that everything was fine, but on Saturday 27Mar2021, he tested positive for 2 covid test. The patient underwent lab tests and procedures which included sars-cov-2 test positive on 27Mar2021. Patient was advised by his doctor to delay his 2nd dose for 90 days. The 2nd dose was originally scheduled on 07Apr2021. Patient was asking for general guidance regarding this. The outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1405569
Sex: M
Age:
State: MI

Vax Date: 03/16/2021
Onset Date: 03/20/2021
Rec V Date: 06/17/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011J201A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Diarrhoea, Nasal congestion

Symptoms: tested positive for Covid one week after getting first vaccination; sinus issues; got what he thought was allergies; This is a spontaneous report from a contactable consumer. This male patient of an unspecified age reported for himself that he received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 16Mar2021 (Batch/Lot number was not reported) as 1ST DOSE, SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient concomitant medications were not reported. The patient tested positive for covid one week after getting first vaccination and sinus issues on an unspecified date. He got what he thought was allergies on Saturday, 20Mar2021. On Tuesday, his nose cleared up and he added that he did not really feel bad, but he wanted to be checked just to be sure. He added that he tested positive for Covid, approximately a week after he got his first vaccine. He was asking what to do about the second vaccination and whether he should receive the second vaccination. He stated that he was not severe so he was wondering if the first shot did do something or he was immune. He wonders if the shot helped with his covid symptoms. He offered information regarding medical institute, and that they can not provide medical advice. He added that he does not mind getting the second vaccine and that he thinks it was interesting that he got Covid. He gave information to contact physician if for medical advice, and stated that he will do that. The patient also stated that can you riddle me this then, Saturday at noon he saw a guy who had the same symptoms with his sinuses also. He said see you later to the guy, and then two hours later had an allergy attack when he was out in the woods, so he figured it was just allergies, but his sinuses continued to have issues. He wanted to know if he could have contracted or have gotten the attack within two hours, like could he have contracted COVID from that other guy, within just two hours. He clarifies that he means could he have developed covid in those two hours. He offered information for medical institute and transfer, but states that his phone was blowing up so he will have to call later. He declined to complete a report or additional information regarding the guy that he saw on Saturday, and state he will tell that guy to call directly. Caller did not provide details whether the man he saw on Saturday had Covid or had received the vaccine. He added that he would like to go through the safety report for himself, but then stated that he had to go. He asked what the incubation time for Covid. He asked how many questions the report was, stated that he will contact his physician to follow up. He added he will go to the websites given for information and to report any events. He said he has to get running and will go online. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1405570
Sex: F
Age:
State: NY

Vax Date: 03/18/2021
Onset Date: 03/01/2021
Rec V Date: 06/17/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling

Symptoms: she developed a fever; joint pain; muscle pain; diarrhea; nausea; chills; arm hurt for a little bit; No appetite; Headache; stomach pain; she is not feeling that well; tested positive to COVID-19 last Tuesday; This is a spontaneous report from a contactable consumer (patient). A 69-years-old female patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number: not reported) dose 1 via an unspecified route of administration on 18Mar2021 as single dose for covid-19 immunisation. The patient's medical history and concomitant were not reported. It was reported that her arm hurt for a little bit. On 25Mar2021 she developed a fever, joint pain, muscle pain, diarrhoea, nausea, and chills. She wants to know if its normal to get the side effects 7 days later. States that she had knee injections on 22Mar2021, she wants to know if that caused her side. She stated she got her first vaccination on 18Mar and she was fine for 6 days, almost 7 days and then on the 7th day laid me to, she developed a fever 101.68 (not clarified) and she have been running this temperature since Thursday, chills, no appetite, diarrhea, some nausea and very slight headache but its still, all on this temperature every day she put she was better today and then just an hour go and took her temp she was feeling chills and whatever and backup to a 101, so her main concern was are you have anyone having a reaction 7 days into a shot but she know its not being around for a long time, so she just want to know that she should be concerned. On 30March2021, She states that she had a sore arm couple of hours and then she was fine. After a week later she got a fever, chills, headache, diarrhea, and stomach pain. She states everything has been going on since then and she is curious, she has never heard of this happening 7 days later. Is this normal or has this happened to anyone else, it sounds like its all reactions, trying to decide if this is a reaction to the shot or if she should go to the doctor.. She explained she went to the doctors and tested positive to COVID-19 last Tuesday. She added she thought she was better, but her temperature was at 101?F today. She asked what to do about the second dose of the vaccine scheduled on 08Apr2021. Caller asked, Should she get the second dose of the vaccine since she experienced these side effects, If she get tested for Covid and am positive, can she get the second dose and how far beyond the 21-day interval could the second dose of the Pfizer-BioNTech COVID-19 vaccine be administered. The patient underwent lab tests and procedures which included body temperature: 101 Fahrenheit on Mar2021, sars-cov-2 test: positive on Mar2021. The outcome of events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1405571
Sex: M
Age:
State: MI

Vax Date: 03/13/2021
Onset Date: 03/20/2021
Rec V Date: 06/17/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 039k20a
Dose Series: 1
Vax Route: SYR
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Rash, Urticaria

Symptoms: This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 13Mar2021 at a single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 20Mar2021, 1 week later first shot, the patient experienced symptoms of COVID-19 and tested positive. 2 days later he got an antibody infusion. His doctor suggested to get the second shot 2 weeks after he feel 100 percent or close and stated that as per the CDC guidelines if he got the shot and the antibodies, he should wait 90 Days. The outcome of the event was unknown. No follow up attempts are possible. Information about Lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1405572
Sex: F
Age:
State: NH

Vax Date: 03/27/2021
Onset Date: 03/28/2021
Rec V Date: 06/17/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Blood pressure decreased, Chest pain, Chills, Confusional state, Decreased appetite

Symptoms: Her arm hurts below the vaccination site in her left arm and the center area to an inch above her elbow; Fatigue; A slight cough; Her left arm began to ache and shake/left arm pain; Her left arm began to ache and shake/left arm shaking; She had arm pain when woke up the next day, and the 28th she had slight swelling; This is a spontaneous report from a contactable consumer (patient). A 61-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955), via an unspecified route of administration, administered in left arm on 27Mar2021 (at the age of 61-years-old) as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient stated on Sunday morning while taking a phone call her left arm began to ache and shake and she had to end the call. Caller states her arm hurts below the vaccination site in her left arm and the center area to an inch above her elbow. Caller states she can't use her left hand too much because it starts to ache and shake, says she was holding the phone talking to someone and after about 50 minutes her arm hurt, then 5 minutes later it started to shake and she had to stop using her hand to hold the phone. She says she had the same problem driving to work last night, she works night, she couldn't use her left arm driving for the trip because it was shaking. then she couldn't do as much of her usual work because it starts to shake and she needs two hands to do her job. She says today she also has a little bit of a cough and fatigue. The patient reported that since it was after her first dose that she had these problems she would like to know if it is safe for her to have her second dose that is scheduled for 24Apr2021. She could use her left arm now and was currently holding the phone in that hand to see if the event reoccurs. She says her arm aches above her injection site to two inches below her elbow, and when it shakes it was like her arm was having a seizure. She was used to having 4 hour phone calls to stay in touch with people and holding a phone for long periods of time was not unusual for her, but her arm could not hold it after that 50 minute call. She had arm pain when woke up the next day, and the 28th she had slight swelling by Saturday afternoon or evening, then she woke up more swelling the next day. She said this was at a mass vaccination site she got her first dose. She had a constant ache, and she hasn't taken any Ibuprofen for it. Since she has been holding the phone this call, it has begun aching more, she has been holding the phone 15 minutes, and it started to ache, but there was no shaking yet. States she is scheduled for the second dose on 24Apr2021. She would like to know if her side effects are normal and if she should receive the second dose. Outcome of the event was unknown. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1405573
Sex: F
Age:
State:

Vax Date: 03/10/2021
Onset Date: 03/17/2021
Rec V Date: 06/17/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025J20-2A
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Dyspnoea, Fatigue, Feeling abnormal, Head discomfort, Headache

Symptoms: She said she is past quarantine peroid and fever free for a week now.; she was exposed to covid and tested positive; This is a spontaneous report from a contactable consumer via medical information team. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: Unknown) via unspecified route of administration on 10Mar2021 as 1st single dose for COVID-19 immunisation. Medical history and concomitant medication were not reported. The patient received her first dose of the Pfizer covid vaccine on 10Mar2021 and on 09Mar2021 she was exposed to covid and tested positive on 17Mar2021. On an unknown date, patient was past quarantine period and fever free for a week now. Patient was scheduled to get her 2nd shot tomorrow and wanted to know if she can already get her second dose. The outcome of event fever was resolved and COVID-19 was unknown. No follow-up attempts are completed; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1405574
Sex: F
Age:
State: MO

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

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Heart rate decreased, Heart rate increased, Hypertension, Injection site pain, Musculoskeletal chest pain

Symptoms: This is spontaneous report from a Pfizer sponsored program COVAX US Support. A contactable consumer reported on behalf of a female patient (mother). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: unknown) via an unspecified route of administration on an unspecified date as UNKNOWN, SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient had the second dose appointment on 06Apr, however tested positive to COVID-19 Virus on an unspecified date. Caller wanted to know if her mother can take the vaccine because her quarantine would almost be over. The patient underwent lab tests and procedures which included SAR-COV-2 test which was positive on an unspecified date. No follow-up attempts are possible. Information about lot/batch cannot be obtained.

Other Meds:

Current Illness:

ID: 1405575
Sex: M
Age:
State:

Vax Date: 03/25/2021
Onset Date: 03/25/2021
Rec V Date: 06/17/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Nausea, Pain, Pain in extremity, Paraesthesia oral, Pyrexia

Symptoms: Caller tested positive yesterday after getting his first covid vaccine; This is a spontaneous report from a non-contactable consumer (patient) reporting himself via Pfizer-sponsored program. A male patient reported that he received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot Number: not provided) via an unspecified route of administration on 26Mar2021 as 1ST DOSE, SINGLE DOSE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that, on 25Mar2021, patient tested positive after getting his first covid vaccine and he would like to know if he can still get his second covid vaccine. Transferred due to getting covid and being scheduled 4 weeks to get his second covid vaccine. The patient underwent laboratory tests and procedures which included SARS-CoV-2 test: positive on 25Mar2021. The outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1405576
Sex: F
Age:
State: WA

Vax Date: 03/13/2021
Onset Date: 03/17/2021
Rec V Date: 06/17/2021
Hospital:

Vax Type: DTAPHEPBIP
Manufacturer: GLAXOSMITHKLINE BIOLOGICALS
Vax Name: DTAP + HEPB + IPV (PEDIARIX)
Lot:
Dose Series: UNK
Vax Route:
Vax Site: LG

Lab Data:

Allergies:

Symptom List: SARS-CoV-2 antibody test, SARS-CoV-2 test negative

Symptoms: This is a spontaneous report from a contactable Female consumer (patient). A 69-year-old (non-pregnant) female patient received second dose of BNT162B2 (BNT162B2, Formulation: Solution for injection, Lot Number: EN6208, Expiration date: unspecified), via intramuscular route, administered in left arm on 13Mar2021 at 11:15 (at the age of 69-year-old) as 2nd dose, single dose for COVID-19 immunization. Patient received the first dose of BNT162B2 (BNT162B2, Formulation: Solution for injection, Lot Number: EN6198, Expiration date: unspecified), via intramuscular route, administered in left arm on 24Feb2021at 15:45 as 1st dose, single dose for COVID-19 immunization. The patient medical history includes flu shots on unspecified date, the vaccine stopped the fractured sleep such bliss, bronchitis I had many times as child. Concomitant medications were not reported. No other vaccine taken 4 weeks prior. On 17Mar2021, after the vaccination, the patient experienced Tiredness/ suddenly exhausted, swollen lips after drinking green tea, Hay fever with little blooming in mountains, rashes, Welts on skin were brushed against things. On 18Mar2021, patient experienced mild headache, eyes and nose running, became allergic to nearly everything, On 20Mar2021, patient experienced Low Blood Oxygen when climbing Low hill 89% and 91%, On 22Mar2021 patient experienced Chest and upper back pain. on unspecified date patient experienced sneezing, shoulder started hurting, migraine and bad sleep. The patient continued to work around home but did not go down the hill again for another week all cleared up by 15 considered taking otc drug Benadryl but warred it might mess immune response of vaccine. Patient said he was migraine- free for about a month after 2nd vaccine had first migraine. Patient usually get 8 hrs of sleep fractured over a 12-hr period of trying to sleep the vaccine stopped the fractured sleep. Lab investigations include heart rate with reading 56 bpm and steady 56 bpm on unspecified dates and oxygen saturation 89% and 91 % on unspecified dates. Good effects were all pain in old injury in left shoulder is gone. Therapeutic measures were taken as a result of events sneezing, eyes and nose running, mild headache, Low Blood Oxygen when climbing Low hill 89+91%. The outcome of the events urticaria, pyrexia, lip swelling, hypersensitivity, chest pain, backpain, fatigue, rash, oxygen saturation and headache was recovered on unspecified date, whereas outcome of other events was unknown. No follow-up attempts possible. No further information expected.

Other Meds:

Current Illness:

ID: 1405577
Sex: F
Age:
State: MA

Vax Date: 03/26/2021
Onset Date: 03/29/2021
Rec V Date: 06/17/2021
Hospital:

Vax Type: HIBV
Manufacturer: MERCK & CO. INC.
Vax Name: HIB (PEDVAXHIB)
Lot:
Dose Series: UNK
Vax Route:
Vax Site: LG

Lab Data:

Allergies:

Symptom List: Ear pain, Hypoaesthesia

Symptoms: she tested positive with COVID-19; This is a spontaneous report from a contactable consumer (Patient) from a Pfizer Sponsored Program COVAX US Support. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Batch/Lot Number: Unknown, Expiration date: Unknown) via an unspecified route of administration on 26Mar2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. No medical information was reported. On 29Mar2021, the patient reported that she tested positive with COVID-19. The clinical outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch cannot be obtained.

Other Meds:

Current Illness:

ID: 1405578
Sex: F
Age:
State: TX

Vax Date: 03/23/2021
Onset Date: 03/30/2021
Rec V Date: 06/17/2021
Hospital:

Vax Type: PNC13
Manufacturer: PFIZER\WYETH
Vax Name: PNEUMO (PREVNAR13)
Lot:
Dose Series: UNK
Vax Route:
Vax Site: LG

Lab Data:

Allergies:

Symptom List: Abdominal pain upper, Dizziness, Dysgeusia

Symptoms: tired; feeling dizzy; headaches; had slight flu like symptoms and was really dizzy and tired; lost the sense of smell and taste; lost the sense of smell and taste; This is a spontaneous report from a Pfizer-sponsored program received from a consumer (patient) reporting for herself. A 31-year-old female patient (31 years age at vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EP6955, Expiration Date: 30Jun2021), via an unspecified route of administration in left arm on 23Mar2021 at 10:00 as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Prior to the first dose of vaccination, she did not receive any vaccinations within 4 weeks. No additional vaccines were administered on same date of the suspect vaccine. The patient stated that 7 after vaccination on 30Mar2021, she noticed she had no smell or taste or anything and asked whether it was an allergic reaction and should she be tested for the virus. She felt very dizzy and tired, and it was a lot more severe. She added that she felt flu like symptoms and believed the event continued at the time of report. She did not require treatment or a visit to her HCP or the Emergency room. She did not receive the 2nd dose of the Pfizer vaccine at the time of report. The clinical outcomes of the events loss of smell and taste, dizziness, tiredness, headache, and flu like symptoms were reported as unknown at the time of report. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1405579
Sex: M
Age:
State:

Vax Date: 03/14/2021
Onset Date: 03/25/2021
Rec V Date: 06/17/2021
Hospital:

Vax Type: RV1
Manufacturer: GLAXOSMITHKLINE BIOLOGICALS
Vax Name: ROTAVIRUS (ROTARIX)
Lot:
Dose Series: 1
Vax Route: PO
Vax Site: MO

Lab Data:

Allergies:

Symptom List: Blood pressure increased, Chest discomfort, Heart rate increased

Symptoms: Tested positive with COVID-19 and he had some other symptoms; This is a spontaneous report from a contactable consumer (himself) to Pfizer-sponsored program. A male patient of unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number: unknown and Expire Date: unknown) via unspecified route of administration on 14May2021 as 1st dose, single dose for Covid-19 immunisation. The patient's medical history and concomitant medications are not reported. After vaccination, on 25Mar2021, he tested positive with COVID-19 and he had some other symptoms. His appointment for the second dose was on 04Apr2021 and he would like to ask whether he needs to get tested negative first before he gets the second shot or shall he proceed going for the second shot. He would like to know if he should proceed or not. However, the concern was, he has the adverse effect that's why caller was trying to transfer it to another program. The patient underwent lab test which included SARS-CoV-2 test positive on 25Mar2021. The outcome of event was unknown. No follow-up attempts are possible. Information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1405580
Sex: F
Age:
State: MA

Vax Date: 03/18/2021
Onset Date:
Rec V Date: 06/17/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot: Eh9899
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site erythema, Injection site pruritus, Injection site swelling, Lymph node pain, Lymphadenopathy

Symptoms: Got first dose and tested positive for Covid-19 virus; This is a spontaneous report from a contactable Consumer or other non-health professional. A contactable consumer reported for a female patient (grandmother). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Batch/Lot number was not reported), via an unspecified route of administration on 18Mar2021 as 1st dose, single dose for COVID-19 immunization. Patient's medical and concomitant medication history were not reported. On an unspecified date, the patient underwent lab tests and procedures which included SARS-CoV-2 test was positive. It was reported that, "reporter, grandmother (patient) got the first dose on 18Mar2021 and patient was supposed to get the second dose on 08Apr2021 however the patient tested positive the COVID-19 virus yesterday and caller wants to know if patient can take the second dose of the vaccine or what the best thing they could do or should do?" patient scheduled to receive the second vaccine in the series on (08Apr2021)." Reporter was informed about Pfizer Medical Information Department. No follow-up attempts are possible; information about lot/batch number cannot been obtained

Other Meds:

Current Illness:

ID: 1405581
Sex: F
Age:
State: CA

Vax Date: 03/25/2021
Onset Date: 03/26/2021
Rec V Date: 06/17/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Unevaluable event

Symptoms: Cold sore; this breakout was bad; This is a spontaneous report received from a contactable consumer. A 55-Year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: unknown) via an unspecified route of administration, in arm left, on 25Mar2021 at 09:30 AM (at the age of 55 years, non-pregnant), as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications was not reported. There was no history of allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 26Mar2021, the patient had experienced Cold sore (I am so curious if you have ever heard this, have not had one in years and this breakout was bad). The treatment received for the adverse event was reported as anti-viral. Outcome of the event was reported as recovering/resolving. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1405582
Sex: F
Age:
State: PA

Vax Date: 03/19/2021
Onset Date: 03/19/2021
Rec V Date: 06/17/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Chills, Dizziness, Injection site pain, Myalgia, Pyrexia

Symptoms: Tasted a bitter, strange taste in her mouth; Several hives on her lips and tongue; Tongue started to feel thick; Her face, it was very red and felt it was a little swollen; Her face, it was very red and felt it was a little swollen; This is a spontaneous report from a contactable consumer or other non hcp. A 72-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, Batch/Lot Number: EP7534), via an unspecified route of administration, administered in arm left on 19Mar2021 14:30 (age at vaccination: 72 years) as SINGLE DOSE for COVID-19 immunization. Medical history included ongoing asthma probably 20 years ago, ongoing hypersensitivity since birth, she does take allergy shots too every 4-5 weeks. Concomitant medications included montelukast (MONTELUKAST) taken at 10mg 1x/day for asthma from an unspecified start date and ongoing; cetirizine hydrochloride (ZYRTEC ALLERGY) taken at 10mg 1x/day for hypersensitivity from an unspecified start date and ongoing; enviomycin (TUM-N) and betacarotene, bioflavonoids nos, biotin, calcium ascorbate, calcium pantothenate, calcium phosphate, choline bitartrate, chromic chloride, colecalciferol, copper sulfate, cyanocobalamin, folic acid, hesperidin, inositol, iron amino acid chelate, lycopene, lysine hydrochloride, magnesium oxide, manganese sulfate, molybdenum trioxide, nicotinamide, phytomenadione, potassium iodide, potassium sulfate, pyridoxine hydrochloride, retinol acetate, riboflavin, selenomethionine, silicon dioxide, colloidal, sodium borate decahydrate, thiamine mononitrate, tocopheryl acid succinate, ubidecarenone, zinc oxide (MULTIVITAMIN & MINERAL) both (TUM-N , MULTIVITAMINS & Mineral) taken for an unspecified indication from an unspecified start date and ongoing. The patient did not receive any other vaccine prior to COVID-19 Vaccine. Caller stated she had mild allergic reaction to the first vaccine and wanted to know if the second dose of the vaccine was same or stronger than the first dose. On 19Mar2021, caller stated her reaction was, she had allergies, her reaction was first almost immediately after, she tasted a bitter, strange taste in her mouth, then she got several hives on her lips. Caller stated her tongue started to feel thick, she could breathe, she had no problem in breathing. Caller stated she did have problems with hives, then she pulled her mask aside for her husband to see her face and it was very red, felt it was a little swollen. Caller states she took two Benadryl, stayed there about an hour as they observed her, came home, and took two Benadryl and everything went away in half an hour. Caller states she talked to the allergist today and was being advised not to get the second vaccine. Caller stated the taste stopped the next morning. Caller states it was gone except the bitterness as soon as she took the Benadryl. Caller states they made her sit there an hour, it took half an hour to get home and in two hours everything was gone except the bitterness. Confirmed bitterness stopped on 20Mar2021. caller wanted to know if she takes the Benadryl before the second would that interfere with the efficacy of the vaccine. The patient underwent laboratory investigations included antibodies were tested and got a level of 1.64 (unit not provided) in 2021. The outcome of the events several hives on her lips and tongue, tongue started to feel thick, her face, it was very red and felt it was a little swollen her face it was very red and felt it was a little swollen reported as recovered on 19Mar2021, tasted a bitter, strange taste in her mouth recovered on 20Mar2021. No follow up attempts are needed. No further information is expected.

Other Meds: MONTELUKAST; ZYRTEC ALLERGY; TUM-N; MULTIVITAMIN & MINERAL

Current Illness: Allergy (Since birth); Asthma (probably 20 years ago, she does take allergy shots too every 4-5 weeks.)

ID: 1405583
Sex: F
Age:
State: CA

Vax Date: 03/29/2021
Onset Date: 03/29/2021
Rec V Date: 06/17/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011L20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site pain, Pain

Symptoms: States she felt like she had Covid; felt terrible; very sick to stomach; bad headache; chills; increased temperature; diarrhea; sore arm; she got too sick after the first dose; body aches; reaction; This is a spontaneous report from a contactable consumer (herself). A female patient of unknown age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration on 29Mar2021 as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The caller stated that she had a reaction after receiving the first dose. On 15Apr2021, she did not want to get the 2nd dose because she was scared. the patient stated that she experienced adverse events like headache, chills, increased temperature, diarrhea, sore arm, and covid-like symptoms. States she felt like she had Covid, states she had Covid 19 around thanksgiving 2020 and now she knows exactly what it feels like. Started three hours after the first dose, had a bad headache and very sick to stomach, after that she got diarrhea, chills and body aches, felt terrible. Lasted for 7 days. She wanted to do the right thing and cancel the appointment instead of just not showing up. Patient asked she went on the computer and read that if you have had covid, you only need one vaccine, is this true. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1405584
Sex: M
Age:
State:

Vax Date: 03/29/2021
Onset Date: 04/05/2021
Rec V Date: 06/17/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site pain, Menorrhagia

Symptoms: Had a urinalysis that tests for alcohol and he tested positive in that test; This is a spontaneous report from a contactable consumer. A male patient of unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number: unknown and Expire Date: unknown) via unspecified route of administration on 29Mar2021 as single dose for Covid-19 immunisation. Patient had to have a urinalysis this past Monday on 05Apr2021 due to having a DUI, urinalysis came back positive for alcohol, he stated he has not had any alcohol and the only other thing he has had are stool softeners. He wanted to know if the Pfizer COVID-19 vaccine could interfere with the urinalysis and He did not want another positive urinalysis. The outcome of the vent was unknown. A review of the Prescribing Information for Pfizer COVID-19 vaccine (LAB-1457-7.0; Revised: 06Apr2021) failed to find any information regarding interaction of the Pfizer COVID-19 vaccine to urinalysis and causing people to test positive for alcohol. Please consult with doctor or health care provider for further guidance, as doctor/healthcare provider is the most familiar with medical condition. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1405585
Sex: M
Age:
State: PA

Vax Date: 02/17/2021
Onset Date: 02/18/2021
Rec V Date: 06/17/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025J20A
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Arthralgia, Chills, Headache, Mobility decreased, Myalgia

Symptoms: chills; fatigue; low grade fever; This is a spontaneous report received from a contactable 79-year-old male consumer (patient). A 79-years-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN9581), via an unspecified route on 17Feb2021 (at the age of 79-years) as 1st dose, single dose in the right arm for covid-19 immunisation. The patient medical history included major radial prostatectomy on 04Feb2021. The patient had no allergies. Concomitant medications were not reported. On unspecified date, the patient experienced reaction of chills and fatigue, low grade fever but in a couple hours that went away which lasted about 7 hours. On 11Mar2021 he got the 2nd dose of the Pfizer vaccine. He was fine. He had no problems until 15Mar20201 (4 days afterwards). He started getting chills, shaking uncontrollably , nausea, fatigue, a little bit of everything. He wouldn't be calling you but this has not subsided. It's been 3 weeks now and He was not feeling well. It ebbs and tides. He been taking a diary. He went to the ER last Monday because He was wheezing in the morning and had shortness of breathe in-between all the other symptoms. They did all kind of blood tests, covid test which was negative, chest x-ray showed bronchitis. Blood work and ultrasound of my bladder. Patient stated that ?They sent me home with a inhaler, steroid and an antibiotic and every day since then it seems like at night 9, or 10 o'clock I start feeling better and sleep through the night. My fever is 97.7F but about 2, 3 or 4 o'clock my fever ticks up a little and I start to feel lousy, my stomach feels... I feel like I have hot flashes; a feeling of warmth with achiness and lack of appetite. So I take my Tylenol 7 or 8 o'clock at night my temperature is 97.7F. I haven't had 1 good day since. I've been to my doctor, ER, I've talked with the CDC. What information do you have for people who have had long term symptoms/side effects? What am I supposed to do? Someone from Pfizer needs to give me advice. If not I'll go to the news network. I don't feel well. It's directly related. No one has given me relief or help. It's impacting my life. I've been sick every day. Is there someone above you who can tell me what to do? I took their (Pfizer's) vaccine that was recommended. It was your vaccine. Not mine. Someone has to have an answer for me. Unless you want to go and have lawsuit and the news. Just think about it, if you had to go through the symptoms of having the flu everyday... please relay this to someone. If I don't heard back within a week, then I'm going ballistic. It's not going to be pretty. Someone has to get back to me to help. I want someone to tell me that I'm not crazy, I'm not the only experiencing this. There has to be an answer. I took your vaccine. You are responsible. I want to know. I can't be the only one in the whole world who is feeling like this. I've been to the ER and the doctors. I've had every side effects but theirs go away in a few days, but mine hasn't. I need advice... that I'm not nuts... something that will help me get better. I want to feel better. It's effecting my family my life. Doesn't it seem odd? I can't be the only one? Someone has to know something. They (drug companies) like to hide the facts. I am sick because I took a (your vaccine) vaccine. I need someone to get back to me'. He reports he did have major surgery about a week before receiving the first injection of the Pfizer covid-19 vaccine. After the first injection, he reports only have mild reactions that went away. After the second dose of the Pfizer covid-19 vaccine, he has been experiencing an achy feeling, heat throughout the body, shivering, shaking, trouble walking, and some fever. He reports taking Tylenol, and that helps, but he is still having symptoms that come and go and it has been 3 weeks since the second injection of the Pfizer covid-19 vaccine. He reports going to the ER for treatment after the second injection, and a COVID-19 test was negative and they did not find anything else other than the Pfizer covid-19 vaccine that would be causing his symptoms. The difference is this hasn't gone away, its now about 3.5 weeks and he hasn't had a good day since then he has been experiencing chills and fever. It goes away for a couple hours, it goes away till around 9 or 10PM at night, then he is good at night, then in the afternoons around 2PM or so the fever kind of comes back and instead of chills he is getting warm flush, when taking his temperature he notices it ticks up. He is taking Tylenol every 6 hours. Patient stated about Fatigue: Yesterday morning he got a blood test and he did not have a fever he was normal 97F, but he could barely take 10 steps, the fatigue varies, it does not coincide with the fever. Looking back over the 3 weeks, the fatigue is better now. The Only thing he thinks could be relevant, on 04FEB2021 he had a major radial Prostatectomy, he was then discharged the following day, he thinks maybe his body never fully recovered from the procedure, but one ever told him anything. The patient underwent lab tests and procedures which included covid test which was negative, chest x-ray showed bronchitis. The patient took Tylenol (Lot SSA042 Expiry Oct2021) for events. The outcome of the events was unknown. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1405587
Sex: F
Age:
State: FL

Vax Date: 03/30/2021
Onset Date: 04/06/2021
Rec V Date: 06/17/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Nausea, Pain in extremity, Pyrexia

Symptoms: Dizziness; Weakness; Stiff neck; Nausea; Heart racing; Loss of appetite; feeling COVID-like symptoms; flu-like symptoms; achy; Diarrhea; Extreme fatigue; This is a spontaneous report from a contactable consumer or other non hcp. A 48-years-old female patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection, Batch/Lot Number: ER8732; Expiration Date: Jul2021), via intramuscularly, administered in left arm on 30Mar2021 15:30 as single dose for covid-19 immunization. The patient medical history inclided allergic to all the cillins (As reported) and gluten. Concomitant medication was not reported. The patient did not receive any other vaccine in four weeks. She does not think so, the last vaccination, she remembers getting was when she was a child. On an unknown date, the patient calling regarding the COVID-19 vaccination. She was concerned because she had an immediate reaction after the shot, dizziness weakness stiff neck nausea heart racing all of that. Then she felt normal things afterwards like sore arm achy tired. that kind of stuff. Last week a week and half after the vaccination the patient started feeling COVID-like symptoms/ flu-like symptoms. She went on Friday and got COVID tested which she was negative. She slept for 19 hours in a 1.5 day period. She called to report these symptoms but also she read on the CDC site that if you had any reaction to the first shot you should not get the second shot. She was concerned on what to do because her second shot is scheduled for next Tuesday. The patient declined stating she has not gone to the doctor she only went to get COVID tested. She does not go to the doctor very often hardly ever. The patient clarified beginning on 06Apr2021 of last week she started having COVID-like symptoms/ flu-like symptoms. She clarifies these symptoms to be achy weak diarrhea extreme fatigue She did not leave the bed for a full day. She slept for 19 hours which is not like her at all. She had nausea. She did not eat she had loss of appetite. She did not have a fever though. She explains she has not recovered completely from these symptoms she was still tired and weak, but she was better now. She did warn them of her allergies prior to getting vaccinated and they had her sit there for 30 minutes after. The patient wants to find out if anybody else has had this type of reaction. The patient underwent lab tests and procedures which included sars-cov-2 test was negative on unspecified date, it was Negative COVID-19 test. The outcome of the event was unknown. Communication: NDC Lot number and expiry date were not probed for her allergy to all the cillins as the caller did not provide a specific product name just a drug class. Communication: Provided report reference number. Referred caller back to her healthcare professional for any treatment recommendations or medical advice. For product specific questions about the COVID-19 vaccine caller was provided the number and hours of operation prior to attempted warm transfer. They was experiencing a high call volume at the time of the call. Caller was placed in the queue to hold for the next available agent. No follow-up attempts are needed. No further information is expected

Other Meds:

Current Illness:

ID: 1405588
Sex: F
Age:
State: TX

Vax Date: 03/24/2021
Onset Date: 04/14/2021
Rec V Date: 06/17/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: UNK
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: I tested positive for pregnancy in 17Mar2021. In 24Mar2021 I got my first covid vaccine from Pfizer; feel cold (really cold) all the time; feel weak; This is a spontaneous report from contactable consumer female (patient, mother reported for herself). A 41-year-old pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date were not reported) via intramuscular route of administration, administered on right arm on 24Mar2021 at 07:15 hours, as 1st single dose (at the age of 41-years-old) for COVID-19 immunization. Medical history included dementia, patient was non-smoker, did not drink alcohol and use illicit drugs during this pregnancy. Patient had one previous pregnancy and no previous maternal pregnancy compilations. Concomitant medication included patient was taking Throne dietary supplement for prenatal supplement from 18Mar2021, daily and ongoing. First day of last Menstrual period was 14Feb2021. Estimated delivery of patient was 21Nov2021. Gestation period at the time of initial exposure was 2 weeks, 1st trimester. Patient had no problems before delivery. No drugs were taken by father (patient's husband) during the mother's pregnancy, father was non-smoker, did not drink alcohol and use illicit drugs during this pregnancy. The patient did not had allergies to medications, food or other products. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. Reportedly, patient was not diagnosed with COVID-19 prior to vaccination. Patient had not been tested for COVID-19 since the vaccination. The patient tested positive for pregnancy in 17Mar2021. On 24Mar2021, she got her first COVID vaccine from Pfizer. Patient first appointment with her OB/GYN was in 05Apr2021. Her doctor did an ultrasound and checked the baby's vital signs. She confirmed that the baby was the right size, and the baby heartbeat was good. She said everything was ok with the baby. On 14Apr2021 she got her second Covid vaccine from Pfizer. Her vaccine was schedule at 10:00 AM. After she got the vaccine, she started to have cramps. About 1:00 PM she started bleeding (light red). She called her doctor and she told her to go to her office. About 1:45 PM She had a new ultrasound. Her doctor said that she did not find any heartbeat in the baby and that she was having an abortion. On 10May2021, it was reported that on unspecified date of 2021, after she got the vaccine, patient had some different symptoms like feel cold (really cold) all the time and feel weak. During all this time she was taking just Thorne-Dietary supplement. Patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date were not reported) via intramuscular route of administration, administered on left arm on 14Apr2021 at 10:15 hours, as 2nd single dose (at the age of 41-years-old) for COVID-19 immunization. Patient called her doctor at 14:00 to 14:30 hours on 14Apr2021, during physician office visit, the doctor did a sonogram and she said that she was having a spontaneous abortion/miscarriage with 7 weeks (2 months) of gestational age. During the sonogram/ultrasound, no heartbeat was detected for fetal. Patient stated that it was the first time that she had miscarriage, her first pregnancy was normal, and her son was born. Patient got the 2 vaccines but wasn't informed about the Lot number. The outcome of feel cold (really cold) all the time and feel weak was unknown and not recovered for rest of the event. No follow-up attempts are needed. information about lot/batch number cannot be obtained. Follow up attempts are completed. No further information is expected. Follow-up (10May2021): This is a follow up-spontaneous report from a contactable consumer. This Consumer reported in response to EDP follow-up questionnaire which included that: New events was added. Pregnancy details, medical history and concomitant medication was added. Clinical course and text were amended accordingly.

Other Meds:

Current Illness:

ID: 1405589
Sex: F
Age:
State:

Vax Date: 04/14/2021
Onset Date:
Rec V Date: 06/17/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Headache, Heart rate increased, Injection site erythema, Injection site pain, Injection site swelling

Symptoms: she didn't feel good; she was feelin bad; she tested positive; This is a spontaneous report from a contactable consumer or other non-health care professional. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 14Apr2021 as 1st dose, single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, caller reports that, his wife received her first dose on Sunday, 14 Apr The Tuesday after she received her first shot she didn't feel good and then wednesday "she was feeling bad" and Friday "I took her to the ER and she tested positive". The adverse event she was feeling bad and she tested positive was resulted in emergency room visit. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on an unspecified date. The clinical outcome of the events was reported as unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021423380 same reporter/drug, different patient/AE

Other Meds:

Current Illness:

ID: 1405590
Sex: U
Age:
State: TX

Vax Date: 04/12/2021
Onset Date: 04/17/2021
Rec V Date: 06/17/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Nausea

Symptoms: This is a spontaneous report from a Pfizer sponsored program Pfizer RX Pathways. A contactable consumer reported that a patient of unspecified age and gender received BNT162B2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot No: UNKNOWN) via an unspecified route of administration on 12Apr2021 at 1ST DOSE, SINGLE DOSE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient reported that, "I received my first dose of the Pfizer vaccine on Monday 12Apr2021 well 5 days later(17Apr2021) I woke up to the worst cold sore outbreak and entire lip is swollen on unspecified date". The patient reported that, "I ever had normally I only get cold sores once per year during cold season when I have an active cold at the moment I have no other cold symptoms and I had never seen anything like this and asked why is this happening to me." The outcome of the events was reported as unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1405591
Sex: M
Age:
State:

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

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: UNK
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site pain

Symptoms: feel tired; covid symptoms; This is a spontaneous report from Pfizer program. This is a spontaneous report from a contactable consumer, the patient. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient had Covid vaccine on Monday and on Wednesday he started to feel tired and had Covid symptoms. He wanted to know if that was normal or not. Outcome of the event was unknown. No Follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1405592
Sex: F
Age:
State: FL

Vax Date: 04/08/2021
Onset Date: 04/01/2021
Rec V Date: 06/17/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site induration, Injection site pruritus, Injection site swelling, Injection site warmth

Symptoms: Infection; This is a spontaneous report from a contactable consumer (Patient) via Pfizer sponsored program. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), second dose via an unspecified route of administration on 08Apr2021 as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine given to patient previously was dose 1 received bnt162b2 for COVID-19 immunisation. It was reported that patient had the second dose of the vaccine on 08Apr2021. After a week on an unspecified date in Apr2021, she had an infection and her doctor gave her Prednisone as a corrective treatment, "she started taking this medicine today". She wanted to know if the drug will interfere with the effectiveness of the vaccine. Were any unaddressed medical questions referred or forwarded to Medical Information reported as yes. The outcome of the event was reported as unknown. No follow-up attempts are possible. information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1405593
Sex: F
Age:
State: FL

Vax Date: 03/31/2021
Onset Date: 03/31/2021
Rec V Date: 06/17/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011j20a
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Chills, Dizziness, Nausea, Pain, Tachycardia

Symptoms: Her blood pressure can be normal for two solid days and then have a reading of 170/110. Her blood pressure was about that high when she got to ER on 10Apr2021, in spite of Propanol.; Her heart started flipping around in her chest; a little localized pain to her right arm where the injection was given; whole body was aching; Caller was so ill she barely ate or slept for three solid days.; Caller was so ill she barely ate or slept for three solid days.; After the vaccine, her joints ached to move. To move her elbow was 10x worse than normal. To get up and walk on her knee, to use that joint, was 10x harder and hurt 10x worse than usual; left knee and left elbow were inflamed; Very dehydrated; aching something terrible, like all of her joints; pain in her neck; Herpes outbreak; Really dizzy and felt weak; Really dizzy and felt weak; her mouth was extremely dry, had a weird metallic/chemical kind of taste; her mouth was extremely dry, had a weird metallic/chemical kind of taste; horrendous burning on the left side, just on the lower part of her rib cage and encompassed the whole top of her stomach; This is a spontaneous report from a contactable consumer (patient). A 55-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 31Mar2021 15:00 (Batch/Lot Number: EW0150) as single dose for COVID-19 immunisation. Medical history included 2 time breast cancer survivor: The latest cancer (second time) was in February of last year, she lost a quarter of her breast again to six 1mm atypical lobular hyperplasia tumors all together in her right breast. Operated on a year ago. They did follow up scan in Sep2020. She was cleared for one year. Osteoarthritis: Patient had several places in her back, but the MRI's shown osteoarthritis was more prominent in her neck. On 18Sep2019, she was injured in whiplash type car accident. Neurosurgeon did complete MRI on all three sections (cervical, thoracic, and lumbar) two weeks after accident. He just redid a second neck MRI and the osteoarthritis is worse, lots of bone spurs. She does have osteosclerosis/arthritis, mainly in her spine, but she also has Carpal tunnel and a bad knee. Degenerative disc disease was diagnosed long ago. Spinal stenosis was diagnosed long ago. She had a previous surgery, 18 years ago, a fusion at C5 and C6 in her neck. She had injured both her left knee and elbow in past from falling down/tripping because of her vision. Sprained Elbow over extended backward, messed-up joint. Fell on left knee: No surgery but did mess up the joint but were inflamed. Borderline diabetic/pre-diabetic started in 2016, she was trying to control with diet. The patient had a little acid reflux, a little chronic pain. She contracted herpes when she was 27 (in 1991). Concomitant medication(s) included propranolol (PROPRANOLOL) taken for blood pressure measurement from Jan2020 to an unspecified stop date; fluorouracil (FLUOROURACIL) taken for skin cancer, start and stop date were not reported. Propranolol: can take one in morning if not too late, sometimes have to wait until 1100 or 1200 and then as needed if later in day or evening have sudden rise can take second one or half of a tablet. Started taking Propranolol after noticing a drop in Potassium and other minerals/electrolytes. She went into kind of an a-fib event with very low potassium, determined have sinus tachycardia secondary to something else. Sometimes, her blood pressure is 100/72, so she can't touch it. She kind of has to use it throughout the day as needed. Her blood pressure goes up and down because of her sinus tachycardia. Her normal blood pressure was considered low normal. Fluorouracil: She was not doing full body treatment (she has done full body before and those are wicked). She was only spot treating a couple places on her face, left arm and right top of shoulder (not where the vaccine was given). In current spot treatment. Battling basil cells and squamous cells since age 32. Been taking about 23 years now and currently in treatment for a couple that tested positive for basil cell. The patient previously received flu shot in sept of 2017, first ever had other than vaccines for school as a child and she got so sick with the Flu in Feb2018 for 10 days, she about died. She never took the flu shot again. Other than that, she has never had any other vaccines unless as a child. The patient had no Prior Vaccinations (within 4 weeks). Family Medical History Relevant to AE(s) was none. The patient received their first dose Pfizer Covid Vaccine on 31Mar2021 and was due to have second shot. The patient had immediate side effects, as well as had some after getting home for at least a week or better. She had immediate reaction and was made to stay in the store for 30 minutes to monitor. The facility has it set up where you go across to another area just across from the Pharmacy once you received the vaccine, and there was a lady there that puts a 15 minute timer on chairs and makes you sit down. The lady just stood there and monitored everyone, making sure no one was having any problems. As soon as the caller sat down, the caller said to her girlfriend who was sitting in front of her, "oh my God, I don't feel right." The lady monitoring everyone asks the patient if she was feeling okay. The patient responded no, and that she was feeling really dizzy and felt weak. The lady pulled over another chair and made the patient put her legs up and she went and got the pharmacist. The pharmacist and additional pharmacist who gave vaccination to the patient also came over. The pharmacist instructed someone to go get a "pulse ox finger reader thing", which was placed on the patient's finger. The pharmacist asked if patient felt anything else which the patient was. As soon as the her feet were put up and the lady went to get the pharmacist, she noticed her mouth was extremely dry, just like a dessert, and she had a really weird taste in her mouth. She clarified it was like a metallic kind of taste, or a chemical kind of taste. She has never tasted anything like that- she was not sure what to compare it to other than it just wasn't right. The pharmacist monitored the pulse ox after it was placed on her finger. Her oxygen level was good at 98 and her heart rate was good in the 80's. The timer was turned to 30 minutes instead of the original 15. All of this took place within the first 5 minutes after the patient sat down. The pharmacist instructed the lady to keep a close eye on patient and to keep the pulse ox on her finger. She kept her feet up the entire time. She couldn't have anything to drink after, the Pharmacist said no, and said if she had any further issues, to call 911. She made it through that 30 minutes. She held onto her girlfriend's arm going out of the store because she felt like her legs were kind of weak and rubbery. She didn't seem to be as dizzy, but the caller still had a real dry mouth and weird taste. States her girlfriend who drove was her neighbor and the patient doesn't drive. When the patient was dropped off at her place, a couple hours later, the patient was being cautious and on guard. Drinking water seemed to alleviate the dryness some in her mouth and kind of got rid of that taste. But then, she noticed horrendous burning on the left side, just on the lower part of her rib cage and encompassed the whole top of her stomach-literally was between belly button and bottom of breast, just that center area of her trunk, from rib cage to rib cage. She explained the burning started on her left side and moved across like fire toward her other rib cage. The burning lasted probably about 5-10 minutes. She tried not to panic and asked herself if she had eaten. She received the vaccine at 1500 and she had eaten lunch. She hadn't been sick or anything from lunch. She doesn't have any stomach issues that would cause intense burning. Caller has a little acid reflux, but wasn't burping or anything. This was just like instant, "on fire" pain that went from left to the right, right through the middle of her trunk area. Then, the burning we

Other Meds: PROPRANOLOL; FLUOROURACIL

Current Illness:

ID: 1405594
Sex: F
Age:
State: GA

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

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 039K20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Tremor

Symptoms: headache; like my throat was swelling; heart rate accelerated; I felt tight in my chest and throat; I felt tight in my chest and throat; I felt warm; nauseous; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 27-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 07Apr2021 02:45 (Batch/Lot Number: EN6204) as 1st dose, single dose for covid-19 immunisation. The patient medical history was not reported. Concomitant medication(s) included drospirenone, ethinylestradiol (NIKKI) taken for a contraception, LORATADINE taken for an unspecified indication and start and stop date were not reported. The patient previously took sulfa drugs. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient was not pregnant at the time of vaccination. The patient experienced headache, like my throat was swelling, heart rate accelerated, i felt tight in my chest and throat, i felt tight in my chest and throat, i felt warm, nauseous on 07Apr2021 03:30. The patient reported that patient was stayed almost 30 minutes on site with the emt and then on the car ride back home patient started feeling like her throat was swelling and she tried to brush it off but then her heart rate accelerated and she felt tight in her chest and throat and then patient felt warm. patient started feeling nauseous and developed a headache so patient drove to the ER. Her throat continued to swell and release for the next few hours. Therapeutic measures were taken as a result of events includes PREDNISONE. The outcome for all events was recovered on unknown date in 2021. No follow-up attempts are needed. No further information is expected.

Other Meds: NIKKI; LORATADINE

Current Illness:

ID: 1405595
Sex: F
Age:
State: MI

Vax Date: 04/08/2021
Onset Date: 04/08/2021
Rec V Date: 06/17/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Erythema, Pruritus

Symptoms: COVID-19 PCR test positive; they had a sore arm that day that went away with no side effects.; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient) reported that a 50-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: ER8732) via an unspecified route of administration on 08Apr2021 at 07:00 pm on left arm as 1st dose, single dose for COVID-19 immunization. The medical history and concomitant medications were not reported. The patient reported that three out of four of her family got the first dose of the vaccine then tested positive for COVID-19 on 20Apr2021. Her husband went in related to his allergies to get tested. She says it was her mother-in-law that had passed, then Tuesday they all got tested and they were all negative. She says her husband started feeling like he had allergies Friday after he cut the grass, and her son is a crazy person about COVID, but he has asthma so he wanted them to all get tested again since allergies can be like COVID, and her husband's test was positive, so then she and her son got tested and they were positive, so they had three positives out of the four family members who got the first dose. She clarifies that her mother-in-law didn't get the vaccine, but she had passed away Tuesday, and they contracted COVID during that time after she passed away at home. They had not gotten any other vaccinations the day of the first dose of the COVID-19 vaccine or in the four weeks prior. Their second dose is scheduled on 29Apr2021, he would like to know if they need to get tested and test negative for Covid-19 before receiving the second dose of the vaccine. They told her May 4th was when they could get their second dose after quarantining. She says that they were all fine after they got the first dose of the vaccine, they had a sore arm that day that went away with no side effects. She says that her arm soreness began that night into the next day, then it went away without treatment the next day after that, so lasting about 24 hours. She says she felt like if she had been able to move her arm after instead of how she slept on it at night, it would have been less, but she didn't get to move it around much since they got it at night. No follow-up attempts are needed. No further information is expected

Other Meds:

Current Illness:

ID: 1405596
Sex: F
Age:
State: NY

Vax Date: 03/29/2021
Onset Date: 04/08/2021
Rec V Date: 06/17/2021
Hospital:

Vax Type: UNK
Manufacturer: UNKNOWN MANUFACTURER
Vax Name: VACCINE NOT SPECIFIED (NO BRAND NAME)
Lot:
Dose Series: UNK
Vax Route: SYR
Vax Site: UN

Lab Data:

Allergies:

Symptom List: Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling, Myalgia

Symptoms: I developed a pretty severe outbreak of genital herpes. I had not had an outbreak like this since I contracted it 22 years ago.; This is a spontaneous report from a contactable consumer (patient). A 54-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: ER8730), via an unspecified route of administration, administered in Left arm on 29Mar2021 at the age of 54-years-old as 2nd dose, single for covid-19 immunisation. Medical history included asthma, hypothyroidism from an unspecified date, Allergies to medications, food, or other products augmentin & CIPRO, genital herpes from an unspecified date and had not had an outbreak like that since she contracted it 22 years ago. Concomitant medication included levothyroxine (LEVOTHYROXINE) taken for an unspecified indication, on an unspecified date received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took first dose of historical vaccine, bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: En6199), via an unspecified route of administration, administered in Left arm on 08Mar2021 13:30 at the age of 54-years-old as single dose for covid-19 immunisation. The patient previously took augmentin [amoxicillin;clavulanic acid] and cipro [ciprofloxacin] and experienced drug allergy. The patient was diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. On 08Apr2021, the patient developed a pretty severe outbreak of genital herpes. She had not had an outbreak like that since she contracted it 22 years ago and no treatment was received for the adverse event. The patient underwent lab tests and procedures which included COVID-19 (sars-cov-2 test): positive on an unspecified date. The reporter assessed events as non-serious with no seriousness criteria of resulting in death, Caused/prolonged hospitalization, Disabling/Incapacitating, Congenital anomaly/birth defect. The outcome of event was recovering. No follow-up attempts are needed. No further information is expected.

Other Meds: LEVOTHYROXINE

Current Illness:

ID: 1405597
Sex: M
Age:
State: MI

Vax Date: 04/08/2021
Onset Date: 04/08/2021
Rec V Date: 06/17/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Cough, Limb discomfort, Pain, SARS-CoV-2 test positive

Symptoms: Sniffles/ runny nose; not feeling normal after all; Sinus congestion; cough; COVID-19 PCR test positive; arm soreness; This is a spontaneous report from a contactable consumer (patient). A 55-years -old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: ER8732), via an unspecified route of administration as single dose on 08Apr2021 at 19:00 into left arm for COVID-19 immunisation. Medical history included pancreatitis. The concomitant medications were not reported. Patient had no other vaccinations the same day as his first dose of the COVID-19 vaccine or in the four weeks prior. On 8Apr2021, patient experienced arm soreness. On 19Apr2021, patient COVID-19 PCR test was positive. Patient stated that he was diagnosed 34 years ago, he has been battling it since then and has numerous surgeries and numerous things since. He had symptoms starting Friday. He says this Friday will have been 7 days, on the 23rd. He says on the following Friday, which is the 30th he was told he could get his second shot, but he was scheduled to get his second shot on the 29th, he wonders if that day made a difference. He says he was symptomatic, so he didn't know where he is at on a timeline to getting the second dose. He says he got the first dose shot the week prior and then that happened to his mom, so going into that weekend he had the allergy symptoms and obviously to play it safely they got tested and they were all negative. He says that following Friday he thought he had normal sinus congestion after cutting the grass, he is also always getting the sniffles from his neighbor's white pollen tree. He says to play it safe he got tested again Monday and that turned out to be positive. He says on the Wednesday the week prior it was negative after the shot they had on the 8th, then this test he had it. He says that his mom passed on the 13th, then on Tuesday which was the 14th they all were tested and all were negative. He says that he got tested again and it was positive after he felt his runny nose and cough that he had originally thought was normal over the course of the weekend was not feeling normal after all, and to play it safe he got tested. He says after his positive test after his first test was negative, because he was positive the second time everyone got tested, and his daughter was the only one who was negative the second test. Enquired ask how they could get information from the facility about when it would be ok to get the second dose, if it was when they had no more symptoms or if it was after a person tested positive or was asymptomatic 10-14 days that they can go get second dose. Enquired when is the best time to get the second dose after testing positive, whether they are symptomatic or asymptomatic.The outcome of the events was unknown. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1405598
Sex: F
Age:
State: MI

Vax Date: 04/08/2021
Onset Date: 04/01/2021
Rec V Date: 06/17/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 039K20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Asthenia, Chills, Headache, Myalgia

Symptoms: arm soreness; This is a spontaneous report from contactable reporter(mother), reporting for her daughter (patient) A female patient of unknown age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration in left arm on 08Apr2021 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unknown date, the patient stated about Pfizer COVID-19 vaccine who says it was hard to figure out where to call. She said that they had their first dose April 8th. She says that they had a family member that passed away last Tuesday, and around that time was when they contracted and tested positive for COVID-19, for which they have been quarantined. She says that there had been a lot of people in and out of where they were after her mother in law passed, and some were wearing masks and some weren't. She says she and her son tested this past Tuesday which was positive, and they told her May 4th was when they could get their second dose after quarantining. She says that her husband was tested Monday and was positive and he was told it would be the 30th or something like that. Caller says that her son was tested Wednesday, and was told he was positive, and he also must be asymptomatic. She says all three of them tested positive out of the four that went, only her daughter was negative. She says that she needs to reschedule shots for the second dose that were scheduled for 24th of April, but she was not sure how to go about that. The patient says her husband went in related to his allergies to get tested. She says it was her mother-in-law that had passed, then Tuesday they all got tested and they were all negative. She says her husband started feeling like he had allergies Friday after he cut the grass, and her son is a crazy person about COVID, but he has asthma so he wanted them to all get tested again since allergies can be like COVID, and her husband's test was positive, so then she and her son got tested and they were positive, so they had three positives out of the four family members who got the first dose. She clarifies that her mother in law didn't get the vaccine, but she she had passed away Tuesday, and they contracted COVID during that time after she passed away at home. She says they contracted something from there, since they haven't been anywhere else and have stayed at home other than going there after her mother in law passed away. The patient says that they were all fine after they got the first dose of the vaccine, they had a sore arm that day that went away with no side effects. She says they all took the COVID-19 shot on April 8th. Caller says that her mother in law passed away on the 13th, and her husband had allergies kind of after, and she and her son had nothing. She says that they have no congestion, fever, none of that stuff. She says she was really shocked when they gave her the result that she was positive. The patient underwent lab tests and investigation results which included COVID-19 PCR test for which the result was negative. The outcome of the events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1405599
Sex: F
Age:
State: NY

Vax Date: 04/20/2021
Onset Date: 04/23/2021
Rec V Date: 06/17/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011J20A
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site erythema, Injection site pain, Injection site swelling

Symptoms: This is a spontaneous report from a contactable consumer or other non hcp. A 33-years-old female patient received BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number, expiration date: unknown), via an unspecified route of administration, administered in Left arm on 20Apr2021 18:00 as 2ND DOSE, SINGLE DOSE, for covid-19 immunization. Medical history included herpes simplex from an unknown date. Concomitant medication included sertraline HCL (SERTRALINE HCL), Ethinylestradiol, etonogestrel (NUVARING) taken for an unspecified indication, start and stop date were not reported. Historical vaccine included first dose of bnt162b2 via an unspecified route of administration, administered in Arm Left on 30 Mar 2021 (Batch/Lot number was not reported) as for covid-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since vaccination, patient had not tested for COVID-19. on 23Apr2021 05:00 the patient stated that patient developed a cold sore the day after my fever from the shot subsided, or three days following the shot. Patient had HSV1 since childhood, but only develop cold sores occasionally. It stood out to me because I had one in mid-March for the first time in a few years, which was normal. Having a second so close to the vaccine made me think it was a secondary effect, or potential reaction to the fever. The patient had no Allergies to medications, food, or other products. Outcome for the events was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds: Sertraline HCl; NUVARING

Current Illness:

ID: 1405600
Sex: F
Age:
State: CA

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

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot: EK9231
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Chills, Feeling cold, Feeling hot, Myalgia, Pain

Symptoms: This is a spontaneous report from a Pfizer sponsored program. A contactable female consumer (patient) of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that patient got first dose of the vaccine and experiencing pain on half of her face and wanted to know if that was okay. There was no any unaddressed medical questions referred or forwarded to Medical Information. The outcome of event was unknown. No Follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1405601
Sex: M
Age:
State: AK

Vax Date: 03/10/2021
Onset Date: 03/01/2021
Rec V Date: 06/17/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Pain in extremity

Symptoms: loss of taste and smell; loss of taste and smell; joint pain; This is a spontaneous report from a contactable consumer (patient's father) reported. A 16-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6199; Expiration Date: Jun2021) via an unspecified route of administration, administered in arm right on 10Mar2021 13:30 as first dose, single dose for COVID-19 immunization. The patient medical history was not reported. There were no allergies reported. Concomitant medication included MULTIVITAMIN, VITAMIN D3 and VITAMIN C. After Received the first dose of Covid Vaccine, the patent had every side effect on the list plus those not listed, loss of taste and smell to some extent and joint pain. He missed 5 days of school. He got it on a Wednesday, 31Mar2021 and was too sick to get out of bed on Thursday, 01Apr2021 and Friday, 02Apr2021. Thursday morning, 01Apr2021 he passed out and hit the floor. On the following Monday, 05Apr2021 he struggled back to school after 5 days, but came home early. He has just been trashed, too trashed to train for his sport, further described as too weak to train, he hasn't trained for 3 weeks. He still has a fever. His local doctor here does not have any suggestions other than he should take acetaminophen and ibuprofen alternately to get rid of the headache and fever. The patient was administered his second dose of Pfizer Covid Vaccine on 31Mar2021. After the 2nd dose of vaccination, the patient experienced Pain in the arm, Redness, Swelling, 2 inch diameter raised circle at injection site, Tiredness, Fever, Shortness of breath, Passed out, Hit the floor, Put a big bump on his head; Chills, Headache, Muscle pain, Leg pain, Fatigue, Too trashed to train for his sport, Joint pain, Swollen glands, Loss of taste and smell to some extent, Brain fog, The time to recover from any exertion seems to be longer by a lot. Onset time after receipt of second dose of Pfizer Covid Vaccine: 3 hours. When patient experienced peak expression of adverse event after receipt of second dose of Pfizer Covid Vaccine: 48 hours. No other vaccine within four weeks prior to the first administration date of the suspect vaccine. The outcome of the events was unknown. No follow-up attempts are needed. No further information is expected.

Other Meds: MULTIVITAMIN; VITAMIN D3; VITAMIN C

Current Illness:

ID: 1405602
Sex: U
Age:
State:

Vax Date: 02/10/2021
Onset Date:
Rec V Date: 06/17/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot:
Dose Series: 2
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Abdominal pain upper, Abnormal behaviour, Adverse reaction, Anger, Asthma

Symptoms: This is a spontaneous report from a contactable consumer (the patient). A patient of unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was unknown), via an unspecified route of administration, in left arm on 10Feb2021 as a single dose for COVID-19 immunisation. Medical history included intracranial pressure increased. Concomitant medication included topiramate (TOPAMAX) taken for an unspecified indication, start and stop date were not reported. The patient previously took first dose of BNT62B2 for COVID-19 immunization on 20Jan2021 and Valtrex for cold sores (which the patient had that through childhood but the patient had not had it for like 10 years. Doctor set patient on Valtrex and then when patient stopped Valtrex it started up again). On an unspecified date, the patient experienced flair out or outbreak of cold sores. It was reported that the patient had seen some article saying that It could be like that a Pfizer vaccine could be a trigger for someone that had that in the past, and wanted to get some information on it. The patient underwent lab tests and procedures which included full blood count: unknown result on an unspecified date. Therapeutic measures were taken as a result of flair out or outbreak of cold sores (oral herpes) with Valtrex. The outcome of event was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds: TOPAMAX

Current Illness:

ID: 1405603
Sex: M
Age:
State: WA

Vax Date: 02/16/2021
Onset Date: 04/26/2021
Rec V Date: 06/17/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 039K20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Consciousness fluctuating, Crying, Dry skin, Epistaxis, Headache

Symptoms: a shooting pain started up into his knee and it just aches all the time; It is irritated where he cannot wear a shoe now/He cannot get up and out of chair/ He cannot do anything; Everything was normal except for that same mass in his foot; he has a soft tumor on both feet/ the tumor is sticking out; his foot started hurting/his right foot is having pain/ the pain is starting to get worse; now I can't walk; This is a spontaneous report from a contactable consumer (patient reported himself). A 79-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Lot Number: EN6201), via an unspecified route of administration, administered in arm left on 16Feb2021 09:00 (at the age of 79-year-old) at a 2nd dose, single dose for COVID-19 immunization. The patient medical history included foot tumor. The patient's concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior vaccinations. The patient previously took historical vaccine of first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Lot Number: EL9265) via an unspecified route of administration, administered in arm left on 29Jan2021 09:00 as single dose for COVID-19 immunization. The patient reported he has a soft tumor on both feet/ the tumor is sticking out, his foot started hurting/his right foot is having pain/ the pain is starting to get worse, now I can't walk, it is irritated where he cannot wear a shoe now/he cannot get up and out of chair/ he cannot do anything, everything was normal except for that same mass in his foot on an unspecified date in 2021, a shooting pain started up into his knee and it just aches all the time on 26Apr2021. AE resulted to visit physician office. Patient is a consumer, asking what do I do or what can I take to make this pain go away. Patient reported that he received both doses of the Pfizer covid vaccine, his first dose in January and his second dose February 1. Patient reported that around the same time that he got his shots his foot started hurting and now I can't walk. Patient reported that he has a soft tumor on both feet but his right foot is having pain, the tumor is sticking out and the pain is starting to get worse. Patient reported that nothing works to take the pain away. Patient reported that he saw his doctor a while back but reports that back then the pain wasn't as bad, they did x-rays and nothing was wrong. Patient reported that now the pain is terrible. Soon after having the COVID vaccine shot in Jan 2021, patient started having foot problems on his right foot. Patient did have a preexisting soft tumor in that foot. It is irritated where he cannot wear a shoe now. Patient can't stand or walk on it. It is constantly aching. A couple of days ago, a shooting pain started up into his knee and it just aches all the time. Patient was wondering if this is one of the side effects. Patient wants to find out if it is caused by the vaccine. Patient had a x-ray three weeks ago, and there was nothing wrong with his foot. Patient had no break, no spurs, or anything. Everything was normal except for that same mass in his foot. Patient thinks the vaccine affected the mass. Patient can't walk on his foot it just aches. Patient foot became irritated in Jan 2021. It was irritating. It has worsened. The shooting pain up to his knee started 26 Apr 2021. Patient just drove to the hospital today to get information and the pain shot up a little bit today. Even when patient is sitting in a chair he has aching and shooting pains in his foot. Patient went to the store in pain. Patient cannot do anything, cannot get up and out of chair, can't turn around with his foot on the floor. The patient underwent lab tests and procedures which included x-ray was normal -he had a x-ray three weeks ago, and there was nothing wrong with his foot. He had no break, no spurs, or anything. Everything was normal except for that same mass in his foot. Outcome of the event a shooting pain started up into his knee and it just aches all the time was not recovered, and rest of the events was unknown. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1405604
Sex: M
Age:
State:

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

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Hypotonia, Lethargy, Respiratory rate decreased, Screaming, Skin warm

Symptoms: He lost feeling in his entire arm.; He had complete numbness in his arm; Later in the day he got tingling and then had feeling back in his arm and hands; This is a spontaneous report from a contactable consumer (patients wife). A 57-year-old male patient 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 unspecified date (at the age of 57-year-old) as 1st dose, single dose for COVID-19 immunization. The patient medical history and concomitant medications. On an unspecified date, the patient had a reaction at the site and they kept him there to monitor him. He lost feeling in his entire arm. He had complete numbness in his arm. Later in the day he got tingling and then had feeling back in his arm and hands. Outcome of the events are reported as unknown at this point of time. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1405605
Sex: F
Age:
State: NY

Vax Date: 02/21/2021
Onset Date:
Rec V Date: 06/17/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 026LZOA
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Vomiting

Symptoms: very sore arm; low grade fever; rash chest and back; electrical shock feeling like upper side of teeth; aches; This is a spontaneous report received from a contactable consumer (Patient). A 58-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: EL9266 and Expiration date was not reported), via an unspecified route of administration, in left arm, on 21Feb2021 at 15:00 (at the age of 58 years), as a single dose for COVID-19 immunisation. The patient medical history and concomitant medications was not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: EL9262 and Expiration date was not reported), via an unspecified route of administration, in arm left, on 31Jan2021 at 15:00 (at the age of 58 years), as a single dose for COVID-19 immunisation. On an unknown date, the patient stated that very sore arm for 2-3 days onset immediate stayed in bed next day aches, low grade fever better by evening, rash chest and back(shoulders) 3rd day electrical shock like feeling right side upper teeth-lasted about 1 week. AE doesn't require a visit to Emergency Room, Physician Office. There was no treatment received. Outcome of the events was reported as unknown. No follow up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1405606
Sex: M
Age:
State: TX

Vax Date: 04/30/2021
Onset Date: 04/30/2021
Rec V Date: 06/17/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 037K20A
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Headache, Limb discomfort, Nasal congestion

Symptoms: Tightness in throat for 15 minutes; light fever; feeling very sluggish; pain when the vaccine was administered.; This is a spontaneous report from a contactable consumer (patient). A 21-years-old male patient received first dose of bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot number and Expiration date: unknown), via an unknown route of administration, in left arm on 30Apr2021 at 16:30 (at the age of 21-years-old) as First dose , single dose for covid-19 immunisation. Medical history included crohn's disease, coeliac disease, asthma and Bactrim allergy. Concomitant medications included amoxicillin (AMOXIL), codeine phosphate, paracetamol (TYLENOL WITH CODEINE) and ibuprofen (IBUPROFEN) taken for an unspecified indication. Patient has not received any other vaccine in four weeks. Prior vaccination, patient was not diagnosed with covid-19. Since the vaccination, patient has not tested positive for covid-19. On 30Apr2021 at 16:30, the patient experienced tightness in throat for 15 minutes, light fever, feeling very sluggish and pain when the vaccine was administered. Therapeutic measures were taken as a result of tightness in throat for 15 minutes, light fever, feeling very sluggish and pain. Treatment received for the events included Tylenol 500 mg. Outcome of events was recovering. No follow-up attempts needed. No further information is expected.

Other Meds: AMOXIL; TYLENOL WITH CODEINE; IBUPROFEN

Current Illness:

ID: 1405607
Sex: F
Age:
State: IL

Vax Date: 04/22/2021
Onset Date: 04/23/2021
Rec V Date: 06/17/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Back pain, Cold sweat, Headache, Nausea, Vomiting

Symptoms: outbreak of herpes on her lip; Herpes AE: states it is getting worse, it started as one now she has seven to eight.; tching around the site of injection, spots of itching, no pattern, little tiny red raised dots, one arm, one near ankle, bunch on her back. So small remind her of tiny insect bites.; Flu Like Symptoms; Low Grade Fever; This is a spontaneous report from a contactable consumer. A 59-year-old female patient received bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot number: EW0164) via an unspecified route of administration in the left arm, on 22Apr2021 at 18:00, as 2nd dose, single dose for COVID-19 immunization. Historical vaccine included the patient received bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot number: EW0150) via an unspecified route of administration, as 1st dose, single dose for COVID-19 immunization. Medical history included oral herpes. Concomitant medications were not reported. On 23Apr2021, the patient experienced herpes outbreak, Arm, Itching around the site of injection, spots of itching, no pattern, little tiny red raised dots, one arm, one near ankle, bunch on her back. So small remind her of tiny insect bites, flu Like symptoms and low Grade Fever. The patient stated nothing happened with the first vaccine. The patient stated that she wanted to self report, and she had some drive time, so she was calling to self report a side effect. The patient also stated she doesn't know how common it was but she read shingles was something that was reported in rheumatology. She had an outbreak of herpes on her lip and used to getting one spot once or twice a year, usually with extreme weather changes. The patient reported that 8-12 hours after the shot, she had multiple outbreaks, 7-8 outbreaks where the lip meets the skin. The patient had called her physician to order Valtrex. The patient also stated what she saw on the websites, there have been reports of shingles outbreaks. Stated she had shingles before, but not the shingles vaccine. The patient received treatment Benadryl and Valtrex. Additional vaccines administered on same date of the Pfizer Suspect was none. Prior Vaccinations within 4 weeks was both doses of the Pfizer Covid Vaccine. The outcome of the event oral herpes was not recovered. Outcome of the event condition aggravated was unknown. Outcome of the event vaccination site pruritis was recovering. On 24Apr2021, the outcome of the event flu like symptoms and pyrexia was recovered. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness: Herpes on lip (Verbatim: Herpes on lip)

ID: 1405608
Sex: F
Age:
State: FL

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

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025j20-2A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site swelling, Limb discomfort

Symptoms: Cold sore on roof of mouth and on inner lower lip; This is a spontaneous report from a contactable consumer (patient) reporting herself. A 42-years-old female patient received bnt162b2 (BNT162B2, solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 01May2021 at 12:15 (Batch/Lot Number: EW0172) as 2ND DOSE, SINGLE DOSE for covid-19 immunisation at Pharmacy or Drug Store (42-years-old at the time of vaccination). Patient received first dose of (BNT162B2, solution for injection), via an unspecified route of administration, administered in Arm Left on 10Apr2021 12:00 (Batch/Lot Number8729) for covid-19 immunisation. Medical history included hypothyroidism from an unknown date and unknown if ongoing and there were no allergies. Concomitant medications included levothyroxine sodium (LEVOTHYROXINE SODIUM), fluoxetine hydrochloride (PROZAC), ibuprofen (IBUPROFEN) taken for an unspecified indication, start and stop date were not reported. Post or prior to the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01May2021, the patient experienced cold sore on roof of mouth and on inner lower lip. Patient did not receive any treatment for the event. The clinical outcome of the event was not recovered. No follow-up attempts are possible. No further information is expected.

Other Meds: LEVOTHYROXINE SODIUM; PROZAC; IBUPROFEN

Current Illness:

ID: 1405609
Sex: F
Age:
State:

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

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Chills, Diarrhoea, Fatigue, Feeling abnormal, Headache

Symptoms: This is a spontaneous report from a contactable consumer (patient herself). A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as 1st dose, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. It was reported that she received her first dose of the Pfizer BioNTech COVID-19 vaccine and on an unspecified date, the patient was sick for 4 days after where she could not get out of bed and could not even get up to eat. She stated that with the second dose of the vaccine, she was sick for 5 days after. The outcome of the events was unknown. Additionally patient states that she was calling to report side effects that her 84 year old mother is experiencing after taking Olmesartan (did verify that spelling with the caller). She states that her mother has been experiencing dizziness, headaches, "always sneezing", "always cleaning her eyes and especially her nose", vomiting, and "terrible" diarrhea. patient reported that this has been going on for "many, many long years." Caller only wanted to call in to report this but did ask how long it has been since Pfizer discontinued making this product. Response: Reviewed the attached VR but let caller know that I was unable to find the discontinuation date for this product as it was not listed. Let caller know that I am only trained to speak on the Pfizer BioNTech COVID-19 vaccine and we can only speak about Pfizer produced products here at Pfizer. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1405610
Sex: M
Age:
State: TN

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

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 037K20A
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Hot flush, Myalgia, Nausea, Tension headache

Symptoms: Shingles; stomach issues/pain in his stomach; constipation; He has lost a lot of weight.; This is a spontaneous report from a contactable consumer (patient). A 67-years-old male patient received bnt162b2 (BNT162B2, Lot number: ER9731 and Expiration date: unknown), via an unknown route of administration, in left arm on 18Apr2021 (at the age of 67-years-old) as first dose, single dose for covid-19 immunisation. The patient had no medical history was not reported. The patient concomitant medications were not reported. Patient had not received any other vaccine within 4 weeks. On 23Apr2021, a week later after first dose of vaccine he got shingles. He had been to his family doctor. He was on medication for it at the time of reporting. On an unknown date in Apr2021, he lost a lot of weight. He was going for an ultrasound and they saw his side. They hold him that the ultrasound could not be done because that was shingles. He was getting the ultrasound because he was having stomach issues which started after the vaccine. He was having constipation and pain in his stomach that started on 21Apr2021 or 22Apr2021 (Wednesday or Thursday as reported). That part was getting better. He was put on Valacyclovir, 1 tablet a day for 10 days. He has three more prescriptions. They are all Prednisone. He was on tapered dose. He took on the first day, then drops down to a smaller dose after three days and then drops to an even smaller dose. Patient went to physician office. Therapeutic measures were taken as a result of shingles (herpes zoster), stomach issues/pain in his stomach (abdominal pain upper). Outcome of events constipation and weight loss was unknown while outcome of event abdominal pain upper was recovering and for event herpes zoster was not recovered. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 636,615

Page last modified: 03 October 2021 5:28pm