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: 1445940
Sex: F
Age:
State:

Vax Date: 04/02/2021
Onset Date: 04/03/2021
Rec V Date: 07/03/2021
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: Severe spasms, whole mouth, shoulders, down both arms, everywhere; Chest pains; Ear infection; This is a spontaneous report from a contactable consumer. A 62-year-old-Female consumer (patient), received bnt162b2 (BNT162B2, Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number ER8732, Expiration Date: 13Jul2021), dose 2 via an unspecified route of administration, administered in Arm Right on 02Apr2021 12:45 (Age at vaccination 62 year) as SINGLE DOSE for covid-19 immunisation. Medical history included, cardiac failure. Concomitant medication(s) included hydrocortisone, neomycin sulfate, polymyxin b sulfate (ANTIBIOTIC EAR). Historical vaccine includes bnt162b2 (BNT162B2, Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number EN6207, Expiration Date: 13Jul2021), dose 1 via an unspecified route of administration, administered in Arm Right on 12Mar2021 12:45 as DOSE 1, SINGLE for covid-19 immunisation. No history of all previous immunization with the Pfizer vaccine considered as suspect. No additional Vaccines administered on Same Date of the Pfizer Suspect. Concomitant Products Antibiotic she did not know the name or dose but has been taking for 5 days. Caller stated she was on lots of medications, as she is in heart failure. But only provided the Antibiotic she has been taking for the last 5 days for an ear infection. This is the only new medication. She stated it was a big pill, not a capsule, by mouth. Caller did not have any further details to provide on report about the Antibiotic. On 03Apr2021 patient experienced severe spasms, whole mouth, shoulders, down both arms, everywhere, on an unspecified date in 2021 chest pains and ear infection. Therapeutic measures were taken as a result of severe spasms, whole mouth, shoulders, down both arms, everywhere took Tylenol and it has not been working. No Emergency Room visit. The patient not wanted to report her AE and be warm-transferred, thus, e-transmitted. Response received was provided disclaimer that Pfizer is unable to make treatment recommendations for individual patients and responded per EUA fact sheet under "6 OVERALL SAFETY SUMMARY". Spoke from CONS document regarding listed adverse events may not be all possible side effects as serious or unexpected side effects may occur. The outcome for event severe spasms, whole mouth, shoulders, down both arms, everywhere was not recovered, for chest pain and ear infection its unknown. No follow-up attempts are needed. No further information is expected

Other Meds: ANTIBIOTIC EAR

Current Illness:

ID: 1445941
Sex: U
Age:
State:

Vax Date: 03/24/2021
Onset Date: 03/30/2021
Rec V Date: 07/03/2021
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: Had little infection; diarrhea; little bit of soreness the next day in arm; This is a spontaneous report from a non-contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown, Expiration date: Unknown), via an unspecified route of administration on 24Mar2021 as dose 1, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient had little infection. On 30Mar2021, the patient experienced little diarrhea and little bit of soreness the next day in arm. Patient stated, patient took the vaccine the 24Mar2021 and have been sit in the office. There was no yell, was quite feeling for about 4,5 minutes before patient took the shot that want to say it really. It would have been some mess was happened by visit. There was, patient just wanted to know it was alright to take it had little infection. 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: 1445942
Sex: U
Age:
State:

Vax Date: 03/01/2021
Onset Date: 03/01/2021
Rec V Date: 07/03/2021
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: Little diarrhea yesterday and little bit of soreness the next day on my arm.; Little diarrhea yesterday and little bit of soreness the next day on my arm.; I took the the vaccine the 24 of this month/I got it 24 and I go back. later on did the second; This is a spontaneous report received from a non-contactable consumer (patient). A patient of an unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: unknown), dose 2 via an unspecified route of administration in Mar2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: unknown) via an unspecified route of administration on 24Mar2021 as single dose for COVID-19 immunization. Patient had a little diarrhea in Mar2021 (yesterday as reported) and little bit of soreness the next day on my arm in Mar2021. Also had little infection in Mar2021. It was reported that patient got dose 1 on 24Mar2021 and went back. Later on did the second in Mar2021. There was, just wanted to know if it is alright to take it, had little infection. Patient had a little diarrhea in Mar2021 (yesterday as reported) and little bit of soreness the next day on my arm in Mar2021. 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: 1445943
Sex: F
Age:
State: NJ

Vax Date: 03/01/2021
Onset Date:
Rec V Date: 07/03/2021
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: soreness at injection site; pain under arm; tired; This is a spontaneous report from a non-contactable consumer (patient). An adult female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left in Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. First dose was administed in left arm in Feb2021. The patient medical history was not reported. No known allergies. The patient's concomitant medications were not reported. The patient experienced soreness at injection site, pain under arm, tired, all on an unspecified date. No treatment. No covid prior or post vaccination. The events outcome was recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1445944
Sex: F
Age:
State:

Vax Date: 04/02/2021
Onset Date: 04/02/2021
Rec V Date: 07/03/2021
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: Fatigue; injection site pain; This is a spontaneous report from a non-contactable consumer (patient). A 29-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 intramuscular on 02Apr2021 (Batch/Lot number was not reported) age at vaccination of 29-years-old, as single dose, for covid-19 immunisation. Medical history included covid-19 from an unknown date and unknown if ongoing. The patient was not pregnant and was not pregnant at the time of vaccination. The There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced fatigue on 02Apr2021 and injection site pain on 02Apr2021. No treatments were given. Since the vaccination, the patient has not been tested for COVID-19. The patient was recovering from the events. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1445945
Sex: M
Age:
State: TX

Vax Date:
Onset Date:
Rec V Date: 07/03/2021
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: felt very sick within a day of the shot; This is a spontaneous report from a contactable consumer or other non hcp. A 59-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation . Relevant medical history and concomitant medications were not reported. The patient experienced felt very sick within a day of the shot (illness) on an unspecified date with outcome of recovered.

Other Meds:

Current Illness:

ID: 1445946
Sex: U
Age:
State: NJ

Vax Date: 12/21/2020
Onset Date: 12/01/2020
Rec V Date: 07/03/2021
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: tested positive 28Dec2020; Post Covid Syndrome Headaches.; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number and Expiration date: unknown), via an unknown route of administration on 21Dec2020 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 21Dec2020 patient was given the first dose of Pfizer covid vaccine, unfortunately unknown to everyone patient was already positive, became symptomatic on 22Dec2020 and tested positive on 28Dec2020. Since that time patient has been experiencing post Covid Syndrome Headaches from an unknown date in Dec2020. Patient would like to know whether should take the second vaccine and when. Outcome of events was unknown.

Other Meds:

Current Illness:

ID: 1445947
Sex: F
Age:
State: OH

Vax Date: 04/05/2021
Onset Date: 03/25/2021
Rec V Date: 07/03/2021
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: SVT; This is a spontaneous report from a contactable physician. A 60-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), (At the age of 60-years) dose 1 via an unspecified route of administration, administered in Arm Right on 15Mar2021 15:00 as DOSE 1, SINGLE, dose 2 via an unspecified route of administration, administered in Arm Right on 05Apr2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included supraventricular tachycardia and History of svt. S/p ablation Onset date: 20-year Hx of sporadic episodes Pertinent details: Hx of 2 ablations- last one Nov2020. Patient was not Pregnant at the time of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not receive any other medications within 2 weeks of vaccination. Patient did not diagnose with COVID Prior to vaccination. Patient did not test for COVID-19 Since the vaccination. No Allergies ware reported. The patient concomitant medications were not reported. The patient experienced supraventricular tachycardia on 25Mar2021. Patient was visited Emergency room for event. Treatment received for the adverse event: Adenosine. It was reported that patient received Treatment: B blocker for 2nd dose. Seriousness Criteria: Important medical event. The outcome of event was recovered on 2021. Follow-up attempts are completed; information about lot/batch number cannot be obtained.; Sender's Comments: Based on the information available and a close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of supraventricular tachycardia. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate

Other Meds:

Current Illness: Supraventricular tachycardia

ID: 1445948
Sex: F
Age:
State: RI

Vax Date: 04/01/2021
Onset Date: 04/01/2021
Rec V Date: 07/03/2021
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: Low grade fever; chills; soreness & bruising at injection site; soreness & bruising at injection site; This is a spontaneous report from a contactable consumer(patient). A 51-years-old non-Pregnant female patient received second dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EP6955), via an unspecified route of administration on 01Apr2021 at 09:30 into right arm as SINGLE DOSE for COVID-19 immunization at clinic. The patient had received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL3247), via an unspecified route of administration on 09Mar2021 at 11:30 am into right arm as SINGLE DOSE for COVID-19 immunization at clinic. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. On 01Apr2021 at 22:00, the patient experienced Low grade fever, chills, soreness & bruising at injection site. No treatment was given for the events. The outcome of the events was recovered. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1445949
Sex: F
Age:
State: OH

Vax Date:
Onset Date:
Rec V Date: 07/03/2021
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: Caller got first dose and then got covid; Caller got first dose and then got covid; This is a spontaneous report from a contactable consumer or other non hcp. This report from a Pfizer sponsored program. This contactable consumer reported for herself that a female patient of an unspecified age received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot number: not reported), dose 1 via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unknown date, caller got first dose and then got COVID. It was reported that caller got first dose and then got COVID and missed her second dose. The clinical outcome of events was unknown. No follow-up attempts are possible, information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1445950
Sex: M
Age:
State:

Vax Date: 03/24/2021
Onset Date: 04/05/2021
Rec V Date: 07/03/2021
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: from 8 to 10 days after receiving the first dose of the vaccine they both took a COVID-19 test (on Monday) and tested positive with symptoms; This is a spontaneous report from a contactable consumer or other non health care professional (patient's wife) via a medical information team. A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number and Expiration date not reported), via an unspecified route of administration in an unspecified anatomical location on 24Mar2021 as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. After 5 days of vaccination, the patient started to develop a reaction in which he lost the smelling sensation, was short of breath and had fatigue and from 8 to 10 days after receiving the first dose of the vaccine, took a COVID-19 test (on Monday) and tested positive. The patient did not have any social contact after the vaccination. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 05Apr2021. The outcome of events was reported as unknown. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1445951
Sex: M
Age:
State: MI

Vax Date: 03/17/2021
Onset Date: 03/29/2021
Rec V Date: 07/03/2021
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: now he's tested positive for Covid as well; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported for a male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), dose 1 via an unspecified route of administration on 17Mar2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient reported has been exposed to someone who has covid on 29Mar2021 and now he's tested positive for Covid as well. Since is living in the same house with husband, she was quarantined because of that and she can not make the 2nd dose on time. She wanted to Know that they're in this kind of situation are they still going to have the 2nd dose. Their 2nd doses were on 07Apr2021. The patient underwent lab tests and procedures which included sars-cov-2 test was tested positive on an unspecified date. The outcome of event was unknown.

Other Meds:

Current Illness:

ID: 1445952
Sex: M
Age:
State: MD

Vax Date: 03/20/2021
Onset Date: 04/01/2021
Rec V Date: 07/03/2021
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: fever; sore; Fatigue; tested positive to have covid virus; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solu-tion for Injection, Lot Number and Expiration date was not reported), via an unspecified route of administration on 20Mar2021 as single dose for covid-19 immunization. Medical history included lymphoma from an unknown date and unknown if ongoing (a lymphoma survivor). The patients concomitant medications were not reported. On 01Apr2021 the patient tested positive to have covid virus. His wife got positive but not taken any of the doses yet. He also mentioned that he experienced fever, sore and fatigue on an unspecified date. The patient will get the 2nd dose on 12Apr2021. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 01Apr2021. Outcome of the events was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1445953
Sex: F
Age:
State: OH

Vax Date:
Onset Date:
Rec V Date: 07/03/2021
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: blood pressure is sky high/ BP was over 200; headache; This is a spontaneous report from a contactable consumer or other non hcp (patient sister).A female patient of an unspecified age received bnt162b2 (BNT162B2, formulation: solution for injection, Batch/Lot number was not reported and Expiry date was reported), dose 1 via an unspecified route of administration on an unspecified date as UNKNOWN, SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported.The patient experienced blood pressure is sky high and bp was over 200, headache on an unspecified date. She wonders if that is related to the vaccine; caller states she does not have the lot number to provide for the sister's Pfizer Vaccine. The patient underwent lab tests and procedures which included blood pressure measurement: over 200. The outcome of the event was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1445954
Sex: F
Age:
State: NY

Vax Date: 03/24/2021
Onset Date: 04/04/2021
Rec V Date: 07/03/2021
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: She was tested positive for the Covid-19; This is a spontaneous report from a contactable consumer (patient) via a Pfizer sponsored program A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), dose 1 via an unspecified route of administration on 24Mar2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient was tested positive for the COVID-19 on 04Apr2021. She wanted to know what she needs to do now (as reported). 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: 1445955
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 07/03/2021
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: We were sick we possibly have Covid; ache; I had a fever for two days off and on; have been sick; This is a spontaneous report from a contactable consumer or other non hcp (patient). This consumer reported similar events for 2 patients. This is 1 of 2 reports. A female patient of an unspecified age received first dose of bnt162b2 (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 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced we were sick we possibly have covid, ache, i had a fever for two days off and on, have been sick. Patient stated my husband and I both got the Pfizer shot on Monday night the first dose, now we have been sick. The patient had a fever for two days off and on and ache. My husband had a fever for 3 to 4 days and could we possibly have gotten Covid from it because he is gonna take the Covid test now because we were fine before the shot but now we find we were sick we possibly have Covid. The clinical outcome of the events was unknown. No follow-up attempts are possible. Information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021416222 Same reporter/diff patient

Other Meds:

Current Illness:

ID: 1445956
Sex: U
Age:
State: MI

Vax Date: 02/08/2021
Onset Date:
Rec V Date: 07/03/2021
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: joint pain; This is a Follow-up spontaneous report from a Pfizer-sponsored program. A contactable pharmacist reported that a patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTEC COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported, Expiration Date: unknown), dose 2 via an unspecified route of administration on 08Feb2021 as DOSE 2, SINGLE for covid-19 immunisation. Medical history included ongoing nodal marginal zone b-cell lymphoma, neoplasm malignant and arthritis. Concomitant medication(s) included ibrutinib (IMBRUVICA) taken for neoplasm malignant; valaciclovir hydrochloride (VALTREX) taken for neoplasm malignant. Historical vaccine included BNT162B2 on 20Jan2021 for covid-19 immunization. The physician reported, he has no antibodies against Sars-CoV-2, he waited a little over a month and saw his oncologist who ran a blood test to see what antibodies he had. He has CLL (chronic lymphocytic leukemia, he is on medication for cancer (Imbruvica and Valtrex). Since he tested negative for antibodies to protect from the virus caller would like to know if possibly the vaccine gives you or helps your immunity with elevated T cells. Also, he added that he experienced joint pain causing pain at the back and knees, but did not have any adverse events such as fever, tiredness etc. after taking the vaccine and he can't identify if it is joint pain due to his arthritis or the side effects of the Covid-19 vaccine. Outcome of events was unknown. No follow-up attempts are possible. Information about lot/batch number cannot be requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021421720 Same product and event, different patient

Other Meds: IMBRUVICA; VALTREX

Current Illness: Small lymphocytic lymphoma (Nodal marginal zone B-cell lymphoma) (Working Formulation)

ID: 1445957
Sex: F
Age:
State:

Vax Date:
Onset Date: 04/01/2021
Rec V Date: 07/03/2021
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: bloody/reddish stool; low platelet count; fatigue; nausea; hot flash; legs feel heavy/leg muscles tired; irritability; anxiety; diarrhea; This is a solicited report from a Pfizer-sponsored program contactable other healthcare professional and contactable 66-year-old female patient reported that she received palbociclib (IBRANCE), via oral from 01Apr2021 (Batch/Lot number was not reported) and ongoing, at 125 mg, daily, via an unspecified route of administration from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at 300 mg, twice day for breast cancer; bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as for covid-19 immunisation. The patient medical history was not reported. Concomitant medications included venlafaxine taken for an unspecified indication, start and stop date were not reported. Current dose: ibrance 125 mg (milligram) daily for 21 days and off for 7 days. patient reported she had fatigue, nausea for 2 minutes followed by a hot flash for 3 min and then goes away but occurs sometimes every two hours but has gotten better. legs feel heavy/leg muscles tired like she's been riding a bicycle for a long time. patient also reports when she started ibrance she had her 2nd covid vaccination and is not sure if that has also contributed to her side effects after starting ibrance. md (medical doctor) aware. no further information given. patient reports previously mentioned fatigue continues and remains the same, nausea continues but is better with anti-nausea medication, hot flashes continue and md prescribed venlafaxine (started today) to help out along with helping new report of irritability and anxiety, and previously mentioned legs feeling physically tired continues and remains the same. patient also has a new report of occasional diarrhea after starting ibrance. md aware. no further information given. The patient underwent lab tests and procedures which included platelet count: low. The action taken in response to the events for palbociclib was dose not changed , for bnt162b2 was not applicable. The outcome of events bloody/reddish stool, low platelet count was unknown, for events fatigue, hot flash, irritability, anxiety, diarrhea, outcome was recovering, for event legs feel heavy/leg muscles tired outcome of not recovered and for event nausea it was recovered. No follow-up attempts are needed. No further information expected.; Sender's Comments: Based on the available information and considering the reported events can be associated with ibrance, its role was considered possible.

Other Meds: VENLAFAXINE

Current Illness:

ID: 1445958
Sex: M
Age:
State: MA

Vax Date: 04/13/2021
Onset Date:
Rec V Date: 07/03/2021
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: experienced fever after first dose; This is a spontaneous report from Pfizer-sponsored program CEP 159558. A male contactable consumer reported for himself who received that BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: unknown), via an unspecified route of administration on 13APR2021 dose 1 single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medication was not reported. Unknowingly patient had possible exposure to Covid 10Apr2021. On an unknown date after vaccination patient experienced fever. Outcome of the events was unknown. Information regarding lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1445959
Sex: F
Age:
State: NJ

Vax Date: 02/16/2021
Onset Date:
Rec V Date: 07/03/2021
Hospital: Y

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: Caller states she has COPD, she was recently in the hospital for a flare up.; muscle aches; Spasms/Muscle cramps/Even my breasts were moving. It was contorting. It was in spasm; headache; Anxiety; blood work showed that Magnesium level was little low; Fatigue/Tired; This is a spontaneous report from a contactable Nurse (reported for herself). A 66-years-old female patient received bnt162b2 (BNT162B2; PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EL9266; Expiration Date: 31May2021), via an unspecified route of administration, administered in right arm on 16Feb2021 (at the age of 66-years-old) as Dose 2, Single for COVID-19 immunization. The patient's medical history included ongoing chronic obstructive pulmonary disease COPD (Coded to Chronic obstructive pulmonary disease) and high blood pressure. Concomitant medications were none.The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot Number: EL9262; Expiration Date: 31May2021),via an unspecified route of administration, administered in right arm on 22Jan2021 (at the age of 66-years-old) as Dose 1, single for COVID-19 immunization. On an unspecified date, the reporter stated that she got spasms. Even her breasts were moving. It was contorting. It was in spasm. Putting on her socks, she got a spasm. It started within 10 days to 2 weeks after the second vaccine. She had normal side effects shortly after the vaccine with headache and fatigue. Then that started to subside. Then the muscle aches started until it got to the point that her hands would contort and twitch. She couldn't put her socks on. It goes through her stomach, back, shoulders, and even her neck. The reporter states that she tried everything, and her doctor said to her there's something definitely wrong. She has COPD, she was recently in the hospital for a flare up. She's having muscle cramps, its been going on since her Covid vaccine, her second one, to the point that she cannot function, it sounds terrible, she can't comb her hair and she couldn't put her sock on the other day and it got pretty bad and her doctor said you need to make Pfizer aware of this. The reporter stated that in the hospital, they had her on with IV drip of magnesium to try and ease the muscle cramps and spasms and they also gave her Valium, which has helped. The reporter states her doctor, her primary care doctor, says they have been through everything to try and nail this down. The reporter states it's debilitating, she can't even roll over at night sometimes in bed. It was in her breast the other night and it was so bad; she could see it moving. The reporter states right now, she's loaded up on Flexeril and valium, and anything to relax the muscle, they gave her so that she could function. The minute she waits for it to wear off, it comes right back, and it doesn't completely go away, there's a buzz to it. The reporter states while speaking, she was experiencing a muscle cramp in one of her legs because she's leaning on it. She didn't have this problem before she got the second shot. Before the second vaccine, it started, she had the normal headache and this and that, but the muscle spasms came on slowly and now they are at a peak where its hard to function. When probed to determine NDC, Lot number or expiry date for the Flexeril and Valium she mentioned earlier in the call, the caller states these medications are dispensed in regular prescription bottles. She clarifies the names of the medications are Diazepam and Baclofen. Baclofen: Reporter reports Baclofen is 10 mg. Reporter states this is the same thing as Flexeril, but it's easier on the stomach. Reporter states she takes it every 8 hours as needed by mouth. Diazepam: She took one last night. Reporter states she takes the medication as needed, but on the bottle it says to take every 8 hours, two tablets by mouth. It also says to not take Xanax with it. Reporter states no LOT or Expiry date. Reporter states the bottle doesn't have all that information. Manufacturer: Mylan. Reporter adds three weeks ago, they put her on Xanax because the anxiety was horrible from it. Magnesium: Reporter states they told her she could continue taking the Magnesium, but they had to cut the dose in half because she was getting diarrhea from it. Reporter states it's just regular Magnesium off the shelf, it's a chelated blend, for sleep support for bone and muscle. Reporter states she was initially taking 200 mg but they cut her back to one a day so now she is taking 100mg once a day by mouth. Reporter provides LOT: 448151B, EXP: Jan2023. Reporter states no NDC or UPC. Reporter states its in a bottle, she sees the barcode, with very little numbers on it, but it doesn't say that. Reporter states in the hospital, she was on IV, she came home the day before Easter, she had quite a bit of it when she was in the hospital. She clarifies the medications are Baclofen and Diazepam, they are dispensed in pharmacy vials. Baclofen: 10mg; Reporter states this is the same thing as Flexeril, but it's easier on the stomach. Reporter states she takes it every 8 hours as needed by mouth. Lot/Exp: Unknown. Diazepam: 5mg. On the bottle it says every 8 hours, two tablets by mouth. Reporter states but she is not supposed to take Xanax with it. Caller states no LOT or Expiry date. Reporter verifies Baclofen and Diazepam are from the pharmacy and are in prescription bottles. Magnesium: Caller states she was initially taking 200 mg but they cut her back to one a day so now she is taking 100mg once a day by mouth. Reporter provides LOT: 448151B, EXP: Jan2023. Reporter states no NDC or UPC. Reporter states its in a bottle, she sees the barcode, with very little numbers on it, but it doesn't say that. Reporter states in the hospital, she was on IV- she had quite a bit of it when she was in the hospital. The reporter stated, "Yes my doctor has first it started I went in the hospital because I had an attack of the, from the COPD and when I was in there, they did blood work and the blood work showed that Magnesium level was little low and I told the doctors that I had muscle cramps, I told them when I was in the hospital that I was having severe muscle cramps ,and they giving me Magnesium in an IV form and it seemed to help minimally and I was also on IV for, IV prednisone, it was actually a, it was cause my breathing, it is a steroid". The events she has COPD, she was recently in the hospital for a flare up assessed as serious (hospitalization). The patient underwent lab tests and procedures which included investigation: little low on an unspecified date (blood work showed that Magnesium level was little low). Therapeutic measures were taken as a result of events. The outcome of the events was unknown.; Sender's Comments: Based on the information currently available,The casual association between the reported events and suspected vaccine BNT162B2 cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Other Meds:

Current Illness: COPD (COPD (Coded to: COPD) From - To - Ongoing)

ID: 1445961
Sex: F
Age:
State: MA

Vax Date: 04/19/2021
Onset Date: 04/19/2021
Rec V Date: 07/03/2021
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: Felt sensation of tightness in chest or fast heartbeat; Felt sensation of tightness in chest or fast heartbeat; Shaking hands; Tingling forearms; Jerking movement in hands; Looked like a parkinson's patient; Brief tingling in lips; Sharp pain in mid back; This is a spontaneous report from a contactable consumer (patient). A 49-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: ER8731), via an unspecified route of administration, administered in arm right on 19Apr2021 at 12:45 (at an age of 49-years-old) as dose 1, single for covid-19 immunisation at Pharmacy or Drug Store. Medical history included asthma, sulphonamide allergy and morphine allergy. The patient's concomitant medications were not reported. Patient not diagnosed with covid-19 prior to vaccination. Patient was not received any other vaccine prior four weeks of vaccination and patient did not receive any medication prior two weeks of vaccination. On 19Apr2021, about 2 minutes after shot the patient experienced shaking hands, tingling forearms, jerking movement in hands looked like a Parkinson's patient. Brief tingling in lips, felt sensation of tightness in chest or fast heartbeat like having had lots of coffee. Sharp pain in mid back this was all very dramatic and fast but disappeared fully within an hour No problems at all overnight or the next day. Since vaccination patient not tested for covid-19. No therapeutic measures were taken as a result of the events. The clinical outcome of the events was recovered on unspecified date in 2021. Follow-up attempts are needed. Further information is requested.

Other Meds:

Current Illness:

ID: 1445962
Sex: F
Age:
State: IA

Vax Date: 04/09/2021
Onset Date: 04/13/2021
Rec V Date: 07/03/2021
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: Shortness of breath lasting over 1 week; Migraine/Severe Headache; Migraine/Severe Headache; This is a spontaneous report from a contactable consumer (patient). A 30-year-old female patient received bnt162b2, via an unspecified route of administration, administered in Left Arm on 09Apr2021 18:00, at the age of 30-years-old, (Lot Number: EP7534) as DOSE 2, SINGLE for COVID-19 immunisation. Medical history included endometriosis, seasonal allergy, and migraine. Concomitant medication included norethindrone; gabapentin; loratadine (CLARITINE); ibuprofen, all were taken for unspecified indication, start and stop date were not reported. Historical vaccine includes dose 1 of BNT162B2 administered on 19Mar2021, 05:45 PM on left arm (No reaction on previous exposure to vaccine). The patient is not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient has not been diagnosed with COVID-19. On 13Apr2021, the patient experienced migraine/severe headache, shortness of breath lasting over 1 week. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The outcome of the events was not recovered. No treatment was received for the events. Since the vaccination, the patient has not been tested for COVID-19.

Other Meds: NORETHINDRONE [NORETHISTERONE]; GABAPENTIN; CLARITINE; IBUPROFEN

Current Illness:

ID: 1445963
Sex: F
Age:
State: PA

Vax Date: 04/14/2021
Onset Date: 04/15/2021
Rec V Date: 07/03/2021
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: No voice; I got very sick; Body aches; Teeth and gums hurt; Teeth and gums hurt; Face burns; Freezing chills; Cough; Extreme fatigue; Sore throat; Headache; Abdominal pain; Nausea; Diarrhea; Laryngitis; Lungs burn; This is a spontaneous report from a contactable consumer. A 49-year-old female patient (non-pregnant) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: Unknown) via an unspecified route of administration, administered in arm left on 14Apr2021 at 13:00 as second dose (at the age of 49-year-old) for covid-19 immunisation. The patient's medical history included hypertension and allergy to penicillin. 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 medication within 2 weeks of vaccination. The patient's concomitant medications were not reported. No other vaccines received within 4 weeks prior to the COVID vaccine. Previously patient took first dose of bnt162b2 (Lot number unknown) via an unspecified route of administration in left arm on24Mar2021 at 13:00 PM for covid-19 immunisation and had no reaction. On 15Apr2021 at 13:00 (PM), the patient experienced no voice, very sick, body aches, teeth and gums hurt, face burns, freezing chills, cough, lungs burn, extreme fatigue, sore throat, headache, abdominal pain, nausea, diarrhea and laryngitis. Patient received the treatment of tylenol, dayquil, in bed for two days. The outcome of events was resolving. Information on lot/batch number has been requested.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event fatigue, headache, nausea, diarrhea, chill and the suspect drug BNT162B2. Also, as there is limited information in the case provided, the causal association between the events aphonia, sickness, general body pain, teething pain, gum pain, burning sensation in face, cough, painful respiration, sore throat, abdominal pain, laryngitis and the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Other Meds:

Current Illness:

ID: 1445964
Sex: F
Age:
State: NY

Vax Date: 03/20/2021
Onset Date: 03/20/2021
Rec V Date: 07/03/2021
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: within a few hours of 1st shot, started feeling "pins & needles" throughout my entire body. Symptoms still continue even after the 2nd shot; This is a spontaneous report from a contactable consumer (Patient). A 58-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN6205), via an unspecified route of administration, administered in left arm on 20Mar2021 at 10:15 (at the age of 58-years-old) as dose 1, single dose, and again received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EWO158), via an unspecified route of administration, administered in left arm on 10Apr2021 as dose 2, single for COVID-19 immunisation in Health Clinic. Medical history included high blood pressure, cholestrol, pvc's. The patient has no known allergies. The patient has not been diagnosed with covid prior vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included acetylsalicylic acid (BABY ASPIRIN), metoprolol, amlodipine, atorvastatin. On 20Mar2021 at 12:00 (within a few hours of 1st shot), patient started feeling pins and needles throughout her entire body. Symptoms still continue even after the 2nd shot. The events resulted in Doctor or other healthcare professional office/clinic visit. The reporter considered the event as Serious. Location of injection information is available for all vaccines received on the same date. No treatment was received for the adverse events. The patient has not been tested for Covid since the vaccination. The outcome of the event was not recovered. Follow up needed, further information has been requested.

Other Meds: BABY ASPIRIN; METOPROLOL; AMLODIPINE; ATORVASTATIN

Current Illness:

ID: 1445965
Sex: F
Age:
State:

Vax Date: 04/09/2021
Onset Date: 04/09/2021
Rec V Date: 07/03/2021
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: Left ear and left side of face from my eye toward ear went numb/Numbness; Left ear and left side of face from my eye toward ear went numb/Numbness; hands swelled/Hands are still showing swelling on day 7; terribly sore arm; light headed; chills(but no fever); This is a spontaneous report from a contactable consumer or other non health care professional(Patient herself) of 54-year-old (non-pregnant) female patient received the first dose of bnt162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: Unknown), via an unspecified route of administration, administered in Left arm on 09Apr2021 08:15 (at the age of 54-years-old) at a single dose for covid-19 immunisation at Pharmacy or Drug Store. Medical history included none and Concomitant medications were not reported. No Known allergies reported. No Allergies to medications, food, or other products. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and Since the vaccination, patient had not been tested for COVID-19. On 09Apr2021, the patient experienced Left ear and left side of face from my eye toward ear went numb, hands swelled, had to take jewelry off. Numbness went away by next morning. Hands were still showed swelling on day 7, still not able to put jewelry on. She had some Normal side effects earlier in the day, terribly sore arm, light headed, chills (but no fever). No treatment was received for the events caused. The outcome of events was recovering. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1445966
Sex: F
Age:
State: WA

Vax Date: 04/14/2021
Onset Date: 04/14/2021
Rec V Date: 07/03/2021
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: fever; hives; nausea; headache; body ache; This is a spontaneous report from a contactable consumer or other non hcp. A 32-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0158), dose 2 via an unspecified route of administration, administered in Arm Left on 14Apr2021 at 08:00 (at the age of 32-years-old) as dose 2, single for covid-19 immunisation. The patient was allergic to Avocado, herbal medicine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included acetaminophen; vitamin c [ascorbic acid]; cordyceps sinensis, ganoderma lucidum, lentinus edodes, trametes versicolor, tremella fuciformis (MUSHROOM 5 COMPLEX). The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: ER8732) dose 1 via an unspecified route of administration, administered in Arm Left on Mar2021 for covid-19 immunisation. On 14Apr2021, the patient experienced body ache in unspecified time, hives at 20:00, headache at 02:00, fever at 20:00 and nausea at 20:00. It was reported that after receiving the second vaccine, from 12 hours after, the patient experienced general body ache and headache. Between 24-36 hours, symtoms (high fever, headache, general body ache, nausea etc.) became severe. 5 days after the second vaccination, sudden hives (inflammatory hives) occurred and the hives area continued to become wider and also, after the first dose, the patient had high fever, general body ache, nausea and headache. Since the vaccination, the patient has been tested for COVID-19. The adverse event resulted in Emergency room/department or urgent care. Upon follow up on 21Apr2021, details with pregnancy information, lot number date and time of vaccination was updated. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 19Apr2021. Treatment was given for the adverse event with Benadryl and hydrocortisone cream. Outcome of the events were not recovered. Follow-up (21Jun2021): Follow-up attempts completed. No further information expected.

Other Meds: ACETAMINOPHEN; VITAMIN C [ASCORBIC ACID]; MUSHROOM 5 COMPLEX

Current Illness:

ID: 1445967
Sex: F
Age:
State: NJ

Vax Date: 03/17/2021
Onset Date: 03/24/2021
Rec V Date: 07/03/2021
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: Symptoms actually got progressed and worsened over time to blisters that actually weeping; He diagnosed the patient with an autoimmune response to the first dose; Developed hives on her trunk and her legs and they were very itchy/Hives did progressed to soles of her feet, top of her hands, her back, her legs; Developed hives on her trunk and her legs and they were very itchy; This is a spontaneous report from a contactable Nurse. An 82-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number: EN6207 and Expire Date: Mar2021) via unspecified route of administration in arm (side unknown) on 17Mar2021 as dose 1, single for Covid-19 immunisation. The patient medical history included melanoma. The patient concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown whether any other medications the patient received within 2 weeks of vaccination. The patient has never had allergic reaction to any type of vaccine in the past or medications. On 24Mar2021, the patient was diagnosed with an autoimmune response to the first dose and prescribed oral steroid treatment. The patient developed hives on her trunk and her legs, and they were very itchy on 24Mar2021. She went to her primary health care physician who recommended Benadryl. The symptoms got progressed and worsened over time to blisters that weeping on an unspecified date. She went to a specialist, a dermatologist, who did biopsy of the blisters however reporter did not have the results of any biopsy, but the dermatologist indicated that she probably has an allergic type reaction to one of the chemicals in the vaccine, one of the ingredients. It was recommended to her by her MD not to get the 2nd dose. It started out initially only on her trunk and her legs after getting the first dose but then it progressed to blisters and then the hives further progressed to other body part, so it was over a week. Progressed more like blisters and itching. After she went to the dermatologist, the hives progressed to soles of her feet, top of her hands, her back, her legs. She continued treatment with Benadryl and topical treatment (unspecified medication) to the skin which really has not helped but the hives as of now were resolving, so has not fully gone away. It was resolving but not resolved yet. The patient revisited her physician and he advised her to seek an allergist's opinion. The allergist determined that the patient did not experience an allergic reaction to the first Covid vaccine. She underwent lab test which included biopsy of the blisters with unknown results on an unspecified date. Device date was reported as 24Mar2021. The outcome of event for autoimmune disorder, hives and itchy was recovering and for blisters it was unknown.; Sender's Comments: The causal association of reported events autoimmune disorder and urticaria in relation to suspected drug bnt162b2 (PFIZER-BIONTECH COVID-19 vaccine cannot be excluded based on temporal association in relation to vax schedule ans symptom presetnatation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate

Other Meds:

Current Illness:

ID: 1445968
Sex: M
Age:
State: MA

Vax Date: 03/23/2021
Onset Date:
Rec V Date: 07/03/2021
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: tested COVID-19 positive/had your first Pfizer shot and then week and half later contracted covid; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 23Mar2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient tested COVID-19 positive a week and a half after receiving the 1st dose so his 2nd dose schedule was moved on 20Apr from 13Apr. Consumer (Patient's wife) was asking on behalf of patient if this was okay confirming that patient already recovered from the virus. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on an unspecified date in 2021. The outcome of event was recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1445969
Sex: F
Age:
State: WI

Vax Date: 04/07/2021
Onset Date: 04/16/2021
Rec V Date: 07/03/2021
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 got tested positive for Covid; This is a spontaneous report from a contactable consumer (patient) from a Pfizer-sponsored program. This consumer reported similar events for 2 patients. This is the 1st of 2 reports. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiration date was not reported) via an unknown route of administration on 07Apr2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 16Apr2021, she got tested positive for covid. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 16Apr2021. She wanted to ask that what would happen and should she receive the second dose of the vaccine. The outcome of event was unknown. No follow-up attempts are possible; information about lot/batch number cannot been obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021438248 same reporter/drug/event, different patient

Other Meds:

Current Illness:

ID: 1445970
Sex: M
Age:
State: FL

Vax Date: 03/31/2021
Onset Date: 04/10/2021
Rec V Date: 07/03/2021
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: Blood pressure was elevated; having daily mild chest pain; mild left neck tension/warm sensations; mild left neck tension/warm sensations; This is a spontaneous report from a contactable consumer (patient). A 47-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 31Mar2021 12:00 (at the age of 47-years-old) (Batch/Lot Number: ER8737) as single dose for COVID-19 immunisation. Medical history included Allergies to medications, food, or other products: Yeast intolerance. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. 10 days after 1st dose vaccination, on 10Apr2021, the patient started having daily mild chest pain and mild left neck tension/warm sensations. This was still continuing at this date. Blood pressure was elevated and saw physician and had blood work. The adverse event resulted in Doctor or other healthcare professional office/clinic visit. Treatment received for the adverse event was Unknown. Outcome of the events was not recovered. Information on Lot/Batch number was available. Additional information has been requested.

Other Meds:

Current Illness:

ID: 1445971
Sex: F
Age:
State: IN

Vax Date: 03/12/2021
Onset Date: 04/01/2021
Rec V Date: 07/03/2021
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: panic attacks; believe that vaccine has negatively effected my hormones; have had a huge increase in migraines; unusually intense period symptoms; carpel tunnel in my hands and wrists; This is a spontaneous report from a contactable consumer or other health professional (patient) of 35-year-old non-pregnant 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 12Mar2021 17:00pm (at the age of 35 years old) (Batch/Lot number was not reported) as dose 1, single and dose 2 via an unspecified route of administration, administered in Arm Left on 09Apr2021 15:45 pm (Batch/Lot Number: EW0162) as dose 2, single both for covid-19 immunization at Pharmacy or Drug Store. The patient's medical history included covid-19 from unknown date and unknown if ongoing and concomitant medications were not reported. No known allergies. No allergies to medications, food, or other products. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient reported that on 01Apr2021, she believed that vaccine had negatively affected her hormones. The patient had a huge increase in migraines, unusually intense period symptoms, carpel tunnel in her hands and wrists, and panic attacks. Adverse event resulted in doctor or other healthcare professional office/clinic visit. The patient receive treatment for the adverse events. and Prescription for migraines. The clinical outcome of the events was not recovered. Information about lot/batch number is available. Follow-up attempts are needed.

Other Meds:

Current Illness:

ID: 1445972
Sex: F
Age:
State:

Vax Date: 03/25/2021
Onset Date: 03/01/2021
Rec V Date: 07/03/2021
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: Pain in Arm; Polyps; Hemorrhage of colon (Large intestinal hemorrhage); This is a spontaneous report based on the information received by Pfizer from AbbVie (Mfr. Control No: 21K-163-3835479-00). A contactable consumer (patient) reported for herself that A 63-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: ER8732), via intramuscular on 25Mar2021 (vaccinated at the age of 63 years) as DOSE 2, SINGLE for covid-19 immunisation; adalimumab (HUMIRA, Solution for injection in pre-filled pen), via subcutaneous from an unspecified date in 2020 (Batch/Lot number was not reported) and ongoing, at 40 mg, 1 in 2 week for ulcerative colitis. Medical history included ex-tobacco user from an unknown date to 2014, former tobacco use: a pack of cigarette for two days or more (stopped 2014), started smoking in her early twenty's and alcohol use from an unknown date and unknown if ongoing, she started to drink on her late twenty's and a glass of wine four times a week. Concomitant medications included hydrochlorothiazide, valsartan (DIOVAN HCT) taken for hypertension; lamotrigine (LAMICTAL), ziprasidone hcl (ZIPRASIDONE HCL), both were taken for bipolar; trazodone taken for sleeping; clonazepam (KLONOPIN) taken for anxiety; multiviti (TS NOS) and potassium taken as supplement; tocopherol (VITAMIN E [TOCOPHEROL]) taken for product used for unknown indication and for all Concomitants no start and stop date were reported. Historical vaccine includes first dose of BNT162B2 (Lot Number: EN6204) via Intra-muscular route of administration on 04Mar2021 for covid-19 immunisation. The patient experienced hemorrhage of colon (large intestinal hemorrhage) on an unspecified date in 2021, polyps on an unspecified date Mar2021 and pain in arm on 25Mar2021. On 17Mar2021, the patient underwent lab tests and procedures which included colonoscopy: several polyps, 6 polyps removed, humira helped her colon. The report received as, the patient stated that she had a colon bleeding for two weeks and stated that she did not take any medications for it and it just so happened that she already scheduled for routine colonoscopy. The patient stated that she did not missed or stop HUMIRA and just took it three days later after the colonoscopy as per her doctor instruction. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The report assessed as other medically important condition. Causality for event hemorrhage of colon (large intestinal hemorrhage) was not related, for polyps was as per reporter (drug/vaccine) and for pain in arm causality was probable. Outcome of the event pain in arm was unknown, event hemorrhage of colon (large intestinal hemorrhage) recovered on an unspecified date 2021 and polyps was recovered on unspecified date Mar2021. No follow-up attempts are needed. No further information is expected.

Other Meds: DIOVAN HCT; LAMICTAL; ZIPRASIDONE HCL; TRAZODONE; KLONOPIN; POTASSIUM; VITAMIN E [TOCOPHEROL]

Current Illness:

ID: 1445973
Sex: F
Age:
State: OK

Vax Date: 01/13/2021
Onset Date: 04/01/2021
Rec V Date: 07/03/2021
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: experienced black eyes; continuous numbness in left arm; continuous migraine; vertigo; This is a spontaneous report from a contactable consumer or other non-HCP. A 30-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EC0142) via an unspecified route of administration, administered in arm left on 13Jan2021 as single dose (at the age of 30-year-old, non-pregnant at the time of vaccination) for COVID-19 immunization. The patient's medical history included arthritis. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK5730) administered in arm left on 22Dec2020 for COVID-19 immunization and experienced no reaction on previous exposure to drug. The patient took albuterol [salbutamol] for product used for unknown indication and experienced drug hypersensitivity. Facility where the most recent COVID-19 vaccine was administered was hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received unspecified other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient had not diagnosed with COVID prior vaccination. And post vaccination, patient had not tested with COVID 19. On 01Apr2021, at 15:30 the patient experienced black eyes, continuous numbness in left arm, continuous migraine, vertigo. The patient underwent lab tests and procedures which included SARS-COV-2 test: negative on 05Apr2021. Therapeutic measures were taken as a result of experienced black eyes, continuous numbness in left arm, continuous migraine, vertigo. The outcome of event was not recovered.

Other Meds:

Current Illness:

ID: 1445974
Sex: M
Age:
State: GA

Vax Date: 03/17/2021
Onset Date: 04/01/2021
Rec V Date: 07/03/2021
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: The D-dimer part of the blood work came back as 0.44; runny nose; lost his taste; lost his smell; coughing stuff up; coughing up phlegm; sneezing; This is a spontaneous report received from a contactable consumer (reporting himself). A 64-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN6207, Expiry 31Jul2021), via an unspecified route of administration in left arm on 17Mar2021 at 11:30 (age at the time of vaccination was 64-years-old) as a single dose for COVID-19 immunization. The patient's medical history included COPD treated by CPAP (continuous positive airway pressure), high blood pressure, cancerous tumors removed from bladder, atrial fibrillation. The patient's history of all previous immunization with the Pfizer vaccine considered as suspect was none. The patient had no additional administered vaccines on same date with the Pfizer vaccine. The patient did not required any visit to emergency room or physician office. The patient had no loss of taste and smell within 4 weeks of prior vaccinations. The patient had no adverse events following prior vaccinations. The patient had no predisposing factors. No culture test was performed. The patient's concomitant medications included Eliquis (apixaban) taken for cardiac disorder from Feb2021 to an unspecified stop date; lisinopril and metoprolol tartrate for an unspecified indication. The patient called about the COVID-19 vaccine. The patient had his first COVID-19 vaccine on 17Mar2021. The patient had no issues with the first vaccine. About 2 weeks after the first dose received maybe around 01Apr2021, the patient started sneezing, having some phlegm, and coughing stuff up. The patient used a CPAP (continuous positive airway pressure) machine at night. Around 09Apr2021, the patient lost his taste and smell. The patient was scheduled for his second COVID-19 vaccine on 10Apr2021 but thought his symptoms were worse than the patient originally thought. The patient went to his doctor on 09Apr2021. The patient's doctor did the nasal swab for the COVID-19 virus. The patient never had a fever or chills. The patient's doctor gave him some erythromycin. The patient also did some blood tests. The patient's COVID-19 virus test came back negative. On the results of his blood tests on the first page, the first thing it says are that the patient's COVID-19 results were negative. The patient's doctor told him that the patient's body showed no response to the COVID-19 vaccine. The patient did not see that this blood test was testing for antibodies. Later in blood test paperwork the patient saw that it said antibodies not detected, does not preclude acute Sars-Cov-2 infection. The patient's paperwork said IgG and IgM were negative. The patient provided the following in a historical context. On an unspecified date in Feb2021, prior to receiving his first dose of the COVID-19 vaccine the patient had some heart problems. The patient gone into atrial fibrillation. The doctor prescribed Eliquis and put him on a heart monitor. The patient took a nuclear stress test and that was ok and now the patient was wearing a heart monitor. The patient's reading from his blood test results. The patient's D-dimer result was 0.44. In the reference range it said anything less than 0.50 was a normal range. But the patient was taking Eliquis and his doctor told him his D-dimer should be zero. The patient's doctor told him his D dimer was elevated. The patient's doctor believed the first COVID-19 vaccine has something to do with his D-dimer result. The caller reports that the patient heard about the Johnson and Johnson vaccine and blood clots but he had not heard anything about Pfizer having problems with blood clots or anything of that nature. The patient now has his second COVID-19 vaccine scheduled for next day on 23Apr2021. The patient's follow up visit with his doctor was on 17Apr2021. The patient's doctor advised him to wait until mid May2021 and start all over with the COVID-19 vaccines but this time his doctor wants him to get the Moderna COVID-19 vaccine. The patient was not sure why his doctor was wanting him to stay away from Pfizer. Was there an indication that the patient was not aware of that the Pfizer COVID-19 vaccine would cause his D dimer to be elevated at 0.44. The patient was aware and there may be other factors that cause his D dimer to be elevated. The patient just wants to see if he can get his second COVID-19 vaccine. The patient just wants to get the vaccine and get on with his life. The patient would not get the vaccine if there was a known reason not to get it. The outcome of the events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds: ELIQUIS; LISINOPRIL; METOPROLOL TARTRATE

Current Illness: Atrial fibrillation

ID: 1445975
Sex: F
Age:
State: IN

Vax Date: 04/07/2021
Onset Date: 04/07/2021
Rec V Date: 07/03/2021
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: Tachycardia; Motion sickness; Numbness of right forearm; Entire body swelling all extremities; itchy red rash: face, neck, upper chest, forearms, thighs, back eyebrows; severe frontal occipital lateral stabbing headache; sore & tender body; sore & tender body; chills; blurry vision; light sensitivity; foggy memory; swollen neck/neck was swelling; nauseated vomiting/Nausea and vomiting; nauseated vomiting/Nausea and vomiting; burning sensation; Right upper shoulder discomfort with swelling that goes into her neck; Light sensitivity; having a rash; rash is itching; scaling, and her skin is peeling; scaling, and her skin is peeling; redness; severe headache; This is a spontaneous report from a contactable Nurse (patient's mother). A 23-year-old female patient (daughter) received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: ER8737 and expiry date was not reported), via an unspecified route of administration, in Arm Left, on 07Apr2021 at 11:00 AM (age at vaccination: 23 year) as a single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccine in four weeks. The patient's medical history included anemic, eczema, gastric reflex, known allergies: citrus food, latex gloves, Compazine, Augment, and headaches from concussions. Concomitant medications included Ferrous Sulfate, Diethylpropion HCL, and glucose, sodium chloride (DNS). The patient was not diagnosed with COVID prior vaccination. The patient was not tested for COVID post vaccination. There was a product complaint to report. On 07Apr2021 12:30, the patient experienced swollen neck/neck was swelling, nauseated vomiting/nausea and vomiting, entire body swelling all extremities, itchy red rash: face, neck, upper chest, forearms, thighs, back eyebrows, severe frontal occipital lateral stabbing headache, sore, tender body and chills. On 07Apr2021, the patient experienced right upper shoulder discomfort with swelling that goes into her neck, light sensitivity, having a rash, rash is itching, her skin is peeling, redness and severe headache. On 09Apr2021, the patient experienced motion sickness and numbness of right forearm. On 12Apr2021, the patient had tachycardia and scaling. When probed to determine when the tachycardia began, the caller mentioned that the tachycardia was noted at the doctor's office. She confirmed the tachycardia began Monday, 12Apr2021. She clarified it was her second doctor's visit so if the caller gave the wrong date, they were able to find it by her records on her second doctor's visit. Caller confirmed with her daughter the tachycardia was still intermittent, it comes and goes. It seems to be that it has improved. She could consider it was medically significant because they didn't know what the root cause was. Her daughter has never experienced tachycardia before being dosed with the Pfizer vaccine. There was not treatment for tachycardia. Her daughter was still having a rash; she was breaking out intermittently. She confirmed she did not report online that her daughter was intermittently breaking out. At that time when she filed the report online, the rash just broke out. At that time, she didn't know if her daughter's rash was going to abate and then re-appear. If so, then she would have had to re-open a new event with a new date and time and rate it. She just looked at her daughter's skin, it's peeling. These were very itchy. Caller then clarified most of these events started the day of the vaccine, 07Apr2021 at 12:30 PM. She confirmed some of these events were reported online on the date of the incident and were still present. The severity of each event was on a grading scale, and right now her daughter's grading scale was 10. Online, the patient couldn't even tell how they really were feeling. The severity of each event needed to be asked. By the lack of getting all the information and the less Pfizer has, the better it looks for Pfizer. When probed for outcome, the caller confirmed the rash was still ongoing and it was medically significant because she was going to have to take her to dermatologist. She has been using hydrocortisone cream as treatment of the rash and it's not working. She did not have the NDC, LOT,EXP for the cream. She explained the skin peeling/scaling has been ongoing. Her skin breaks out in a rash and then becomes really scaly and then it peels. She clarified overall, she had a rash, but the rash was itching, had redness, scaling, and her skin was peeling. On scale of 1 to 10, the caller would rate this event as a 10. She confirmed and that it's continuous/ongoing and had not improved. Stated the rash was not to any localized area on her daughter's body, it's all over. She clarified further the rash can appear on her daughter's eyes, chin, cheeks, forearm, wrist, and leg. The severe headache was reported on the day of the vaccine as well as the rash, too. The severe headache was ongoing; caller gives it a grade 10+. She confirmed the headache was medically significant. It did prevent her daughter from driving a car, reading, or doing activities. Caller added that the headache was also disabling because it disables her daughter from functioning at her normal capacity, she's been hindered. Her normal activities she could not perform if the headache was present. The headache was described as stabbing, excruciating pain and burning sensation. When probed for the outcome of her daughter's severe headache, the caller explains it's in between persistent and worsening. On a good day, it's a grade 8.5. On a bad day, it's a grade 10+. No medical treatment for headache, she was not really allowed to do anything. She was waiting for Pfizer vaccine to wash out of her daughter's system. She explained her daughter was laying low and not introducing any more drugs to enter her body since she had a reaction. Caller again stated they were waiting for Pfizer's vaccine to wash out of her daughter's system because they feel as though something was triggering the rash that keeps appearing and the headaches were still there on a grade level of 10+. Her daughter was afraid to take medications, so they were having to do treatments like hot compresses to her daughter's head and neck, massaging her head/neck/back and turning the lights off. The Nausea and vomiting began on 07Apr2021 and was still ongoing. No treatment for nausea. Her daughter just gets still and goes to sleep. When the headaches were excruciating, it brings on nausea and vomiting. Also, she noticed motion sickness. When her daughter was riding in the car and she was experiencing a headache, she had terrible motion sickness. Caller confirmed the caller never had this motion sickness prior to the vaccine. The motion sickness was still ongoing. Her daughter was not treating the motion sickness in any way. She states maybe her daughter has taken one Zofran because it was so bad. No further details provided. The numbness of the right forearm started on 09Apr2021. She confirms the numbness is still ongoing, it comes and goes, intermittently and did not receive any treatment. On 07Apr2021, her entire neck was swelling, left and right side. The left side was better but the rightnside had intermittent swelling, there was ongoing swelling on the right side of her neck and did not receive any treatment and just rubbing of her daughter's neck. Her daughter also has right upper shoulder discomfort with swelling that goes into her neck that was ongoing. She confirmed this event to be medically significant and it has hindered her daughter's normal activity if her shoulder was swollen too bad and she was hurting. Her daughter just started physical therapy. The light sensitivity was still ongoing. If her daughter was not experiencing a headache, the light sensitivity was pretty good and treatment included dark rooms/ black out. Her daughter was following up with an allergy testing by the allergy doctor. She has to find out if there were any active ingredients in the Pfizer vaccine that triggered her daughter's reaction. Caller stated, "something in the COVID-19 vaccine trigge

Other Meds: FERROUS SULFATE; DIETHYLPROPION HCL; DNS

Current Illness:

ID: 1445976
Sex: F
Age:
State: CA

Vax Date: 04/08/2021
Onset Date: 04/18/2021
Rec V Date: 07/03/2021
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: Left arm fell asleep; uncontrollable nausea and vomiting; gradually got more nauseous; I was hyperventilating; Woke up with a headache; Had extreme vertigo with headache; body aches; disorientation; very tired; This is a spontaneous report received from a contactable consumer (Patient). A 38-year-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: WAG6975), via an unspecified route of administration, administered in Arm Right on 08Apr2021 14:00 (at the age of 38-years-old) as single dose for covid-19 immunisation. Medical history included anxiety and DVT in lower leg 7 years ago from surgery. Concomitant medications included bupropion hydrochloride (WELLBUTRIN) and cetirizine hydrochloride, pseudoephedrine hydrochloride (ZYRTEC DUO). Patient had no known allergies. Patient did not receive any other vaccines in four weeks. Patient was not diagnosed with covid-19 prior to vaccination, and she was not diagnosed with covid -19 since vaccination. On 18Apr2021 08:00, patient experienced left arm fell asleep, was hyperventilating, woke up with a headache, gradually got more nauseous, had extreme vertigo with headache, uncontrollable nausea and vomiting, body aches, disorientation and very tired. It was reported that she ended up in the ER 10 days after vaccine. Woke up with a headache then gradually got more nauseous. Had extreme vertigo with headache and uncontrollable nausea and vomiting. Left arm felt asleep, and she was hyperventilating. Couldn't stop vomiting until the Er gave her an injection and pills. Had body aches later that day and the next day and disorientation and very tired. No fever. Patient received Iv fluids, injection for nausea RX for vertigo as a therapeutic measure to treat adverse events. The events were recovered with sequel. Follow-up attempts are possible. Further information is expected.

Other Meds: WELLBUTRIN; ZYRTEC DUO

Current Illness:

ID: 1445977
Sex: F
Age:
State:

Vax Date: 04/08/2021
Onset Date: 04/21/2021
Rec V Date: 07/03/2021
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: tested positive for COVID-19; tested positive for COVID-19; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot number and Expiration date were not reported), via an unspecified route of administration on 08Apr2021 as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On 21Apr2021, the patient experienced tested positive for COVID-19. It was reported that the patient received first dose of Pfizer-BioNTech COVID-19 Vaccine on 08Apr2021 and had a small family gathering with fully vaccinated people, with not fully vaccinated people, and everyone managed to get sick. The patient tested positive for COVID-19 on 21Apr2021. 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: 1445978
Sex: F
Age:
State: TN

Vax Date: 04/21/2021
Onset Date: 04/21/2021
Rec V Date: 07/03/2021
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: rash on cheeks, jawline and neck; facial swelling; itch skin around jawline, some welting.; This is a spontaneous report from a contactable consumer (patient). A 56-year-old non-pregnant female patient (not pregnant at the time of vaccination) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: ER8731), via an unspecified route of administration in left arm on 21Apr2021 at 14:45 (at the age of 56 years old) as single for covid-19 immunisation. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: ER8734), via an unspecified route of administration in left arm on 29Mar2021 at 05:45 PM (at the age of 56 years old) for covid-19 immunisation. The patient's medical history was not reported. The patient had known allergies to sulfa based meds, chlorine, latex, wasp sting, seasonal environmental allergy (spring). Concomitant medications received within 2 weeks of vaccination included gummy multi-vitamin, fish oil, calcium, magnesium. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. No symptoms for 1st dose. 2nd dose received around 2:45 pm and on 21Apr2021, around 8:45 pm patient experienced itch skin around jawline, some welting. Woke up following day with rash on cheeks, jawline and neck, took 2 Benedryl before bedtime, following day some facial swelling rash lower back. Emailed Dr. instructed to take Zyrtec day, and Pepcid then Benedryl at night. Followed instructions, following morning woke up to even more facial swelling once oval face was square. Went to walk-in clinic for steroid shot. The event resulted in: Doctor or other healthcare professional office/clinic visit. Treatment received for the adverse event: injection of dexamethasone and dexamethasone. Reporter considered events as non-serious. The outcome of the events was unknown. No follow-up attempts are needed. No further information is expected.

Other Meds: FISH OIL; CALCIUM; MAGNESIUM

Current Illness:

ID: 1445979
Sex: F
Age:
State: AR

Vax Date: 04/22/2021
Onset Date: 04/22/2021
Rec V Date: 07/03/2021
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: shortness of breath; dizzy; felt very unwell; This is a spontaneous report from a contactable consumer (patient). A 46-year-old non-pregnant female patient (not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown), via an unspecified route of administration in right arm on 22Apr2021 at 10:00 as a single dose for COVID-19 immunization. Medical history included Lupus and Hypothyroidism from an unknown date and unknown if ongoing. Patient had known allergies to Suprex and Septra. Concomitant medications included methylprednisolone acetate (MEDROL [METHYLPREDNISOLONE ACETATE]); naltrexone for lupus, start and stop date were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. The patient had received a DePo medrol Steroid Shot and is on Low Does Naltrexone for lupus. On 22Apr2021, at 04:00, 5 hours after the shot she became very dizzy and shortness of breath. She also felt very unwell. Day two, she felt worse and could not breath alerting me to go to the ER to get checked out. The event resulted in: Emergency room/department or urgent care. The patient received treatment due to the events with ativan shot. The clinical outcome of events was recovering. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds: MEDROL [METHYLPREDNISOLONE ACETATE]; NALTREXONE

Current Illness:

ID: 1445980
Sex: F
Age:
State: MN

Vax Date: 04/23/2021
Onset Date: 04/01/2021
Rec V Date: 07/03/2021
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: severe abdominal pain; diarrhea and vomiting; diarrhea and vomiting; mucous and bloody stool; bloody stool; This is a spontaneous report from a contactable consumer (Patient). A 49-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EZ736), via an unspecified route of administration, administered in left arm on 23Apr2021 at 10:45 (at the age of 49-years-old) as dose 2, single for COVID-19 immunization. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0151), via an unspecified route of administration, administered in left arm on 02Apr2021 at 10:45 as dose 1, single for COVID-19 immunisation. Medical history included childhood asthma, tonsillitis and benignant ovarian cystoma. There were no known allergies. The concomitant medications included unspecified over-the-counter medicines. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. On 24Apr2021 at 01:15 AM (at the midnight of the next date of vaccination), the patient experienced severe abdominal pain, diarrhea and vomiting. In the next morning, severe abdominal pain and bloody stool were present. Although three days passed after vaccination, mucous and bloody stool were currently present. No treatment was received for the adverse events. Patient had not been tested for COVID-19 since vaccination. The outcome of the events was not recovered. Follow-up attempts completed. No further information expected.

Other Meds:

Current Illness:

ID: 1445981
Sex: M
Age:
State: CO

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

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: New onset seizure. Total of 4; This is a spontaneous report from a contactable consumer (patient). A 32-year-old male patient received bnt162b2 (BNT162B2), via an unspecified route of administration, administered in left arm on 02Apr2021 07:00, at the age of 32-years-old, (Lot Number: ER8737) as DOSE 1, SINGLE; and via an unspecified route of administration, administered in right arm on 23Apr2021 07:00 (Lot Number: EW0171) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included seizure on 01Apr2021 05:00AM. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. On unspecified date on Apr2021, after receiving the vaccine, patient had new onset seizure, total of 4. The event required ER visit, and the patient was hospitalized for 2 days due to this. Post vaccination, the patient been tested for COVID-19, tested with nasal swab with negative result on 24Apr2021. The outcome of the event was recovering. Information on Lot/Batch number was available. Additional information has been requested.

Other Meds:

Current Illness:

ID: 1445982
Sex: F
Age:
State:

Vax Date: 04/08/2021
Onset Date: 04/01/2021
Rec V Date: 07/03/2021
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: diagnosed with a COVID-19 active infection; This is a spontaneous report from a non-contactable consumer or other non hcp(Patient). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 08Apr2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunization .The patient medical history and concomitant medications were not reported. she received the first dose of the Pfizer's COVID-19 vaccine on 08Apr and a week later she was diagnosed with a COVID-19 active infection that required a visit to the Emergency Room. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on unknown date in Apr2021.The Consumer had an appointment for the administration of the second dose of the vaccine on May the 1st. AE for the COVID-19 active infection of the Patient and the visit to the ER. 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: 1445983
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 07/03/2021
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: Compression fracture in her back.; This is a spontaneous report from a contactable consumer(patient). A female patient of unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot/batch number: not provided), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient medical history and concomitant medication was not reported. Patient stated that she had recently taken Flexeril, a muscle relaxant, for a compression fracture in her back. She did not specify if it was prescribed to her before vaccination or in between vaccine doses. Patient received Pfizer Covid19 vaccine and asked if there was a contraindication with taking Flexeril because she was due for second dose tomorrow. The outcome of the event was unknown. Follow-up attempts not completed; information about lot/batch number cannot be obtained. No further information expected.

Other Meds:

Current Illness:

ID: 1445984
Sex: U
Age:
State: NJ

Vax Date: 03/24/2021
Onset Date: 03/01/2021
Rec V Date: 07/03/2021
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: My tongue has been burning, covered in swollen taste buds, and been swollen since the 4th day after the first shot on 24Mar; My tongue has been burning, covered in swollen taste buds, and been swollen since the 4th day after the first shot on 24Mar; My tongue has been burning, covered in swollen taste buds, and been swollen since the 4th day after the first shot on 24Mar; This is a spontaneous report from a contactable consumer or other non hcp. A patient of unspecified age and gender 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 24Mar2021 as single dose, for second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 14Apr2021 as single dose for covid-19 immunization. Medical history and concomitant medications were not reported. It was reported that I want to make you aware of my reaction to the Covid 19 vaccine. My tongue has been burning, covered in swollen taste buds, and been swollen since the 4th day (28Mar2021) after the first shot on 24Mar It started to subside a couple of days before the season shot so my Dr told me to go ahead with the second shot on 14Apr. Again, on Day 4 my tongue went crazy again and remains that way today. I am now in fear of a booster and do not know where to go from here. Treated w/ max doses of Benadryl, steroids, Pepcid. The outcome of the events recovered with sequelae. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1445985
Sex: M
Age:
State: TX

Vax Date: 03/18/2021
Onset Date: 03/19/2021
Rec V Date: 07/03/2021
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: a knot appeared just to the right of the bruise about the size of a silver dollar/about a size of a nickel; bruise on my inner elbow; This is a spontaneous report from a contactable consumer (patient). A 50-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), at the age of 50 years old via an unspecified route of administration, administered in Arm Left on 18Mar2021 11:00 (Batch/Lot Number: EN 6207) as DOSE 2, SINGLE for COVID-19 immunisation. Medical history included hypothyroidism from an unknown date and unknown if ongoing. Concomitant medications included levothyroxine sodium (SYNTHROID) taken for an unspecified indication, start and stop date were not reported; liothyronine taken for an unspecified indication, start and stop date were not reported; and varenicline tartrate (CHANTIX) taken for an unspecified indication, start and stop date were not reported. The patient previously took BNT162B2, (lot number: EL 9266), at the age of 50 years old, dose 1, single on 25Feb2021 11:00AM in the left arm for COVID-19 immunization. The facility where the most recent COVID-19 vaccine was administered was in the doctor's office/urgent care. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that 24 hours 19Mar2021 11:00 AM after the injection, the patient stated, "I woke up with a bruise on my inner elbow, 24 hrs after that on 20Mar2021 a knot appeared just to the right of the bruise about the size of a silver dollar. 24 hours after that on 21Mar2021 another knot appeared just below the bruise about the size of a nickel. Still have the large knot as of 28Apr2021." The events resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient was given steroid shot and antibiotics as treatment for the events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. The events did not result in death and was not life threatening. The event did not cause hospitalization and was not disabling and was not a congenital anomaly. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was not recovered. No follow-up attempts are needed. No further information is expected.

Other Meds: SYNTHROID; LIOTHYRONINE; CHANTIX

Current Illness:

ID: 1445986
Sex: M
Age:
State: AZ

Vax Date:
Onset Date:
Rec V Date: 07/03/2021
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: Heart started fluttering; his asthma has been worse; headache or migraine; headache or migraine; This is a spontaneous report received from a Pfizer sponsored program. A contactable consumer (patient's wife) reported that a male patient of unspecified age received the BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot/batch number, expiry date and NDC number: not provided) via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunisation. The patient's medical history includes ongoing asthma. Concomitant medications were not reported. Reporter stated that since her husband received the covid vaccine, his asthma has been worse, and his heart started fluttering and also has had a headache or migraine on an unspecified date. Reporter and her husband both received the Pfizer covid vaccine on an unspecified date. Reporter does not know right now if patient's symptoms are related to the covid vaccine. Reporter does not know all the details about patient's symptoms to report about them. Outcome of the events was unknown. Information on the lot/batch number has been requested. Follow-up attempts completed. No further information expected.

Other Meds:

Current Illness: Asthma

ID: 1445987
Sex: F
Age:
State:

Vax Date: 04/13/2021
Onset Date:
Rec V Date: 07/03/2021
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: Neuropathy; Vomiting; Severe coughing; Sick; Sputum; since the pfizer covid vaccine shot, all her pains have completely disappeared; sleeping for 2 days afterwards; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 65-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-119 VACCINE, Solution for injection) via unknown route of administration on 13Apr2021 as dose 1 single for COVID-19 immunization. Medical history included diabetic, neuropathy in her left hand and shoulder (gabapentin), pain was constant felt like a stabbing pain, prevented her from sleeping at night, she could not lift her left hand, slipped disc, pain in her neck (prednisone and another medication). Concomitant medications were none. It was reported that patient received 1st dose of pfizer covid vaccine on 13apr and was due for her second shot on the 4May. After the vaccination in 2021, stated she became very sick with vomiting, severe coughing with a lot of sputum and was sleeping for 2 days afterwards. States she was really concerned about her symptoms she went to urgent care on april 25th. stated the symptoms she experienced were all the symptoms of covid. She had a covid test done which was negative in 2021. Adds that prior to the vaccination, she had a history of neuropathy in her left hand and shoulder; pain was constant felt like a stabbing pain and prevented her from sleeping at night and she couldnt lift her left hand. She took gabapentin for the neuropathy and had been on disability since last year. Prior to the vaccination, she also had pain in her neck from a slipped disc and was given prednisone and another medication. since the pfizer covid vaccine shot, all her pains have completely disappeared in 2021, she has stopped taking her gabapentin and can lift her left hand. States I have 'felt so different since the shot'. patient was also diabetic. 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: 1445988
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 07/03/2021
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: Lack of drug effect; This is a solicited report Facilitated Collect based on the information received by Pfizer (MFR Control No. # 21K-163-3870248-00). A contactable 46-year-old female consumer (patient) reported for herself that. A 46-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), intramuscular on an unspecified date (age at vaccination 46-years) (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation; adalimumab (HUMIRA, Suspension for injection in pre-filled pen) , subcutaneous from an unspecified date (Batch/Lot Number: 1138527) to an unspecified date, at unspecified dose for Psoriatic arthritis. The patient medical history and concomitant medications were not reported. On an unspecified date patient experienced lack of drug effect (drug ineffective) (medically significant). On an unknown date, the patient experienced Humira did not work. COVID-19 vaccine was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The action taken in response to the event for adalimumab was unknown. Outcome of the event was not recovered. The reporter's assessment of the causal relationship of the event with the suspect product was not reported at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the event Drug ineffective and suspect drug BNT162B2 cannot be excluded.

Other Meds:

Current Illness:

ID: 1445989
Sex: M
Age:
State: MI

Vax Date: 04/26/2021
Onset Date: 04/01/2021
Rec V Date: 07/03/2021
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: scratchy throat; ear ache; mild headache; Heart racing; dizziness; heart flip flopped and sped up, that lasted 10 minutes; gassy and reflux type chest pressure with feeling trouble breathing/Difficulty breathing; gassy and reflux type chest pressure with feeling trouble breathing; allergic reaction; This is a spontaneous report from a Pfizer sponsored program. via contactable consumer or other non hcp. A 55-year-old male patient received bnt162b2 (BNT162B2, Formulation: solution for injection, Batch/Lot Number: EW0158 and expiry date was not reported) via intramuscular route of administration, administered in Arm Left on 26Apr2021 at 10:00 as dose 1 single, for covid-19 immunisation, (received the first dose of the Pfizer vaccine a week ago today, I had some reactions to the first shot, and am trying to determine whether or not to get the second shot). Patient medical history allergy to Penicillin diagnosed 2 years ago. He was advised as a child he was allergic to it, but the local medical provider wanted to actually prove if he was actually allergic and he was tested to verify. He was also allergic to the carrier that they give it to you in. Concomitant medication included cetirizine hydrochloride (ZIRTEC, Batch/Lot number and expiry date was not reported), 1 tablet daily for allergies (Started within the last year). There was no prior Vaccinations (within 4 weeks) and no AE following prior vaccinations. There was no history of previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available). There was no family history. There was no relevant test. He did not take prior vaccination. The patient experienced within 5 minutes had dizziness on 26Apr2021 at 10:05, and my heart flip flopped and sped up, that lasted 10 minutes. I went home and later in the day I had mild headache on 26Apr2021 at 12:00 that came and went away after about 5 minutes, then on26Apr2021 at 12:05, ear ache lasted about the same amount of time and then on 26Apr2021 at 12:10 a scratchy throat and that went away, on Apr2021 gassy and reflux type chest pressure with feeling trouble breathing on 26Apr2021 that was later in the day and carried into the majority of the next day and Within 5 minutes of getting shot, he had the dizziness and heart racing. Difficult breathing was at 14:00. It was worse the following morning at 10:00. That is when he took Tums and Benadryl and by 14:00, they resolved. Headache was at 12:00 This would go away and then earache and then scratchy throat and then difficulty breathing. Ear Ache at 12:05, Scratchy throat at 12:10. There was no ER or physician's office required. Dizziness at 10:05, Heart racing at 10:05. The reporter states, He received the first dose of the Pfizer vaccine a week ago today, had some reactions to the first shot, and trying to determine whether or not to get the second shot. He had the shot at 10am, within 5 minutes had dizziness, and my heart flip flopped and sped up, that lasted 10 minutes. He went home and later in the day he had mild headache that came and went away after about 5 minutes, then he had an ear ache lasted about the same amount of time and then a scratchy throat and that went away, had gassy and reflux type chest pressure with feeling trouble breathing that was later in the day and carried into the majority of the next day. He saw in an article that a man who was hospitalized, they gave him Pepcid, and epinephrine, and Benadryl. So he took 3 tums, and two Benadryl and within a few hours symptoms decreased and felt fine. Looking at the vaccination facility where we got the vaccine, it states, there was a remote chance of severe allergic reaction. He wasn't hospitalized, etc. He did reach out, because he have tested for Penicillin reaction, he spoke to his allergy doctor, so they aren't very helpful. they said to front load with an antihistamine. They consider a severe allergic reaction if he were hospitalized and intubated. Reporter wanted to know if there was anything that has to go on the vaccination card, as to why he may not have received the 2nd dose, like if it was due to an allergic reaction. Within 5 minutes of getting shot, he had the dizziness and heart racing. It lasted 5-10 minutes. It felt like his heart flip flopped and it could have just been an increase in heart rate. The difficulty breathing happened after he came home and it was about 2 hours after the shot. Before that, he had a headache that only lasted a few minutes and it went away. Then an ear ache, which was 5 minutes after that. Then he had a scratchy throat and that went away, then the breathing portion of it kind of started that day and it continued and got worse until the next morning. It felt like he had gas and/or reflux type feeling and it was harder to take a deep breath. He saw online where someone had been treated for the same thing and was given Epinephrine, Pepcid and Benadryl. He does not know the person and read about this individual that was treated for it. He does not have any information to report for this person. Patient stated he took 3 Tums and 2 Benadryl and it resolved within a couple of hours the following morning from having taken the shot. He was allergic to penicillin diagnosed previously and was concerned about getting the shot but they said he would be fine. He had dizziness, and heart racing that lasted 10 minutes. He also was having difficulty breathing and had reflux for 8 hours for which he took a Benadryl. He would like to know if he can get second dose after experiencing side these effects. On the factsheet, it said this would be considered a severe reaction. He does not have a date, manufacturer, lot or expiration for the penicillin he was allergic to. He got tested in the last 2 years at University and tested that he was actually allergic. He later stated it was suggested in childhood that he was allergic, but never properly diagnosed until a couple of years ago. The outcome of event (dyspnoea, dizziness , ear pain, throat irritation, palpitations and Headache) was recovering and rest of events were unknown. Follow-up attempts completed. No further information expected.

Other Meds: ZIRTEC

Current Illness:

ID: 1445990
Sex: F
Age:
State: MI

Vax Date: 04/08/2021
Onset Date: 04/01/2021
Rec V Date: 07/03/2021
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: Yesterday my back started having the same problems; Arms hurt; My lips and eyes were swollen; Neck swelling; My lips and eyes were swollen; I got hives and rashes all over my face, arms and chest thighs; I got hives and rashes all over my face, arms and chest thighs; chills; My muscles were hurting so much; Fever; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient herself) reported that a 25-year-female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and expiration date was not reported) via an unspecified route of administration on 08Apr2021 as single dose for COVID-19 immunization. Patient medical history included She was allergic to clams and COVID-19. Concomitant medications were not reported. Lab data included as blood work on an unspecified date results reported as allergic to clams (seafood) and COVID-19 test on an unspecified date in Jan2021 with positive results. On 23Apr2021 she got hives and rashes all over face, arms and chest thighs. On 23Apr2021 at night she went to the ER. They gave her Benadryl and steroids to see what happens. They did not prescribed anything, got one Benadryl and one steroid. They told her to just to observe. The next day she was fine. On 24Apr2021 started to get the hives again. On 27Apr2021 it was reported as patient lips and eyes were swollen and she saw her doctor and had blood work to see if she was allergic to anything. She was allergic to clams (seafood) but nothing else. In Apr 2021 she experienced chills, fever it was normal but two weeks later she got all these rashes and hives. Her doctor gave me Benadryl for 10 days and steroid for 5 days. She was scheduled on 29Apr2021 for the 2nd dose. She did not get, doctor wanted me to wait until she was done with steroids. Two days ago, her steroids were done, hives were going away it was the 28th and 29th her arms hurt. On the 29th her back started the same thing (like my hands and arms). Her muscles were hurting so much, felt like poking me with needles. On 02May2021 back started having the same problems. She was COVID positive in Jan and got better from it. Caller asked if there was seafood in the vaccine. Response was received as shellfish, fish, seafood and emailed as requested. She had a side effect after the first dose of the vaccine. It was asked as should she get the second dose and response was she should not get the Pfizer-BioNTech COVID-19 Vaccine if she had a severe allergic reaction after a previous dose of the vaccine or if she had a severe allergic reaction to any ingredient of the vaccine. The decision to receive the second dose for any other reason cannot be made by Pfizer. We refer you to speak to your healthcare provider about the risks of the vaccine compared to the risks of potentially not being fully protected against COVID-19 infection. She had a bad reaction on the 23Apr had a swollen lips and neck. The outcome of events (Fever and chills) was recovered on an unspecified date in Apr2021 and unknown for other events. Information about batch/lot number has been requested.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 636,615

Page last modified: 03 October 2021 5:28pm