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: 1276967
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 05/01/2021
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: very little arm trouble the next day (barely); This is spontaneous report from a contactable consumer (patient) via Pfizer sponsored program. This consumer reported events for both doses of bnt162b2. This is for the first dose. An 86-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The first shot the patient had no issues. The patient told them he wanted them to give it to him slow. He had very little arm trouble the next day (barely). The outcome 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-2021407944 Same patient, different dose and event

Other Meds:

Current Illness:

ID: 1276968
Sex: M
Age:
State:

Vax Date:
Onset Date: 04/10/2021
Rec V Date: 05/01/2021
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: feeling crappy/feeling bad; chills; felt clammy and was sweating; was unsteady and couldn't stand to cut the grass / wasn't as easy on his feet and out of balance; couldn't stand to cut the grass; after receiving the vaccine the ringing in his ears also came back and was getting worse as well; This is a spontaneous report received from a contactable consumer reporting for himself. This 62-year-old male patient received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unknown date in 2021, for COVID-19 immunization. Medical history included COVID in Dec2020 and he had ringing in his ears, also known as tinnitus, and this was clearing up and almost gone. Concomitant medications were not reported. The patient felt okay on 10Apr2021 but was unsteady and couldn't stand to cut the grass. The patient wasn't as easy on his feet and out of balance and this was his only symptom on 10Apr2021. On 11Apr2021 the patient was feeling crappy and wanted to know if he should go to the hospital. When he went to church on 11Apr2021 morning he began feeling bad and almost left because he had chills, felt clammy and was sweating. He had COVID in Dec2020 and he had ringing in his ears also known as tinnitus and this was clearing up and almost gone but after receiving the vaccine the ringing in his ears also came back and was getting worse as well. His doctor told him that people who had COVID prior to receiving the vaccine may have an increased immune response and he guessed that it was what was taking place with him currently but he did not like it and did not want to go through it again with the second dose. Events outcome was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1276969
Sex: F
Age:
State: MI

Vax Date: 12/18/2020
Onset Date: 03/19/2021
Rec V Date: 05/01/2021
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: COVID19 infection well after successful vaccination; COVID19 infection well after successful vaccination; This is a spontaneous report from a contactable other health professional. A 43-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: EJ1685), dose 1 via an unspecified route of administration, administered in Arm Left on 18Dec2020 as single dose, dose 2 via an unspecified route of administration, administered in Arm Left on 25Jan2021 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number:EJ1686) as single dose for COVID-19 immunization. On an unspecified date the patients medical history included drug hypersensitivity(Penicillin, Rocephin). On an unspecified date concomitant medications included sertraline hydrochloride (ZOLOFT), amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), amlodipine (AMLODIPINE) taken for an unspecified indication. The patient previously took rocephin [ceftriaxone sodium] and experienced drug hypersensitivity. On 19Mar2021 the patient experienced covid19 infection well after successful vaccination, covid19 infection well after successful vaccination. The outcome of the events recovering.; Sender's Comments: The event COVID19 is most likely an intercurrent condition. Based on temporal relation, the association between onset of event COVID19 and vaccination cannot be ruled out.

Other Meds: ZOLOFT; ADDERALL; AMLODIPINE

Current Illness:

ID: 1276970
Sex: F
Age:
State: OH

Vax Date: 04/07/2021
Onset Date: 04/08/2021
Rec V Date: 05/01/2021
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: feeling unwell; Just stayed in bed and rode it out.; slight rash at injection sight/red rash; injection site itchy; armpit swollen/armpit swollen; 103 fever; sweats; severe pounding headache; no energy; tired; chills; wiped out/weak; nausea; diarrhea; no appetite; This is a spontaneous report from a contactable consumer or other non hcp. A 57-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot Number: ER8729) dose 2 via an unspecified route of administration, administered in right arm on 07Apr2021 11:00 as SINGLE DOSE for covid-19 immunization. Medical history included Blood pressure, Diabetic, potassium and some known allergies of Sulfa, Bees. Historical vaccine was covid 19. The patient's concomitant medications were not reported. On 08Apr2021 at 12:00 AM, the patient experienced chills, sweats, up to 103 fever, severe pounding headache, no energy, tired/wiped out/weak, nausea, diarrhea, no appetite, red rash at injection site, itchy, armpit swollen, started about about 12 hours after shot. The patient stated that first 3 days was roughest. Everything above lasted for 4 days. Day 5 just little energy, feeling unwell and slight rash at injection sight/sight swelling armpit and no appetite. Just stayed in bed and rode it out. The outcome of the events was reported as recovering. The action taken in response to the events for bnt162b2 was not applicable.

Other Meds:

Current Illness:

ID: 1276971
Sex: F
Age:
State: MI

Vax Date: 03/01/2021
Onset Date: 03/01/2021
Rec V Date: 05/01/2021
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: sore arm; aches; chills; overall tiredness; This is a spontaneous report from a contactable consumer. Follow-up (20Apr2021) was received from same reporter and processed together with initial information. An adult female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: Unknown) via an unspecified route of administration on unspecified date in Mar2021 as single dose for COVID-19 immunization. The patients' medical history and concomitant medications were not reported. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown if the patient was diagnosed with COVID-19 prior to vaccination. It is unknown whether the patient is pregnant at time of vaccination. On Mar2021, the patient experienced sore arm, aches, chills, overall tiredness. It was unknown if the patient received treatment to the events. It was unknown if the patient has been tested for COVID-19 since the vaccination. Outcome of the events was recovered on unspecified date in 2021. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1276972
Sex: F
Age:
State: MI

Vax Date: 03/01/2021
Onset Date: 03/01/2021
Rec V Date: 05/01/2021
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: Dose 2: headache, chills, sore arm; Dose 2: headache, chills, sore arm; Dose 2: headache, chills, sore arm; Aches; This is a spontaneous report from a contactable consumer. An adult female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: Unknown), dose 2 via an unspecified route of administration on Mar2021 as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was unknown whether the patient diagnosed with COVID-19 prior to vaccination. On an unspecified date Mar2021, the patient experienced Dose 2: headache, chills, sore arm, and aches. It was unknown whether the patient has been tested for COVID-19. Treatment received for the events was unknown. The outcome of the events was recovered. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1276973
Sex: F
Age:
State: CT

Vax Date: 04/07/2021
Onset Date: 04/07/2021
Rec V Date: 05/01/2021
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: injection site soreness; general body aches; upset stomach; This is a spontaneous report from a contactable consumer (patient's guardian). A 28-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: unknown), via an unspecified route of administration on 07Apr2021 at 16:15 at single dose for COVID-19 immunization. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: unknown), via an unspecified route of administration on 17Mar2021 at 04:15 PM at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient was not allergic to medications, food, or other products. The patient received other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 07Apr2021 at 19:00, the patient experienced injection site soreness, general body, aches, upset stomach. No treatment was received for the adverse events. The outcome of the events was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained

Other Meds:

Current Illness:

ID: 1276974
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 05/01/2021
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: I just do not feel good; I was kind of feeling weak and now I am feeling even worse; Shortness of breath; Mental fatigue; Headache; Chills; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included had knee replacement surgery on 08Mar2021 and was kind of feeling weak. The patient's concomitant medications were not reported. The patient went on Wednesday to get the Pfizer vaccine and just did not feel good. The patient had knee replacement surgery on 08Mar2021 and was kind of feeling weak before getting the shot and now was feeling even worse. The patient had shortness of breath and mental fatigue. The patient had headache that would not go away, patient had chills. The outcome of events feeling weak before getting the shot and now was feeling even worse and headache was not recovered; other events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1276975
Sex: M
Age:
State: PA

Vax Date: 04/09/2021
Onset Date: 04/09/2021
Rec V Date: 05/01/2021
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: Chills; aches in bones and muscles; aches in bones and muscles; fatigue; This is a spontaneous report from a contactable consumer (parent) reported for his/her son. A 19-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 09Apr2021 at 09:00 AM (Lot number: EP6955) on the right arm as single dose for covid-19 immunization. Medical history included depressed left ventricular function due to COVID-19. Prior to vaccination, the patient had diagnosed with COVID-19. Concomitant medications included fexofenadine hydrochloride (ALLEGRA); metoprolol tartrate; probiotic; ascorbic acid, ergocalciferol, folic acid, nicotinamide, panthenol, retinol, riboflavin, thiamine hydrochloride (MULTIVITAMINS); that patient received within 2 weeks of vaccination. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 19Mar2021 at 09:00 AM (lot number: EP6955) on the right arm as single dose for covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced chills, aches in bones and muscles, fatigue; that the symptoms started late evening 09Apr2021 at 23:00. Treatment of Tylenol received for the adverse event. The outcome of the events was recovered on 11Apr2021. No follow-up attempts are needed. No further information is expected.

Other Meds: ALLEGRA; METOPROLOL TARTRATE; PROBIOTICS; MULTIVITAMINS [ASCORBIC ACID;ERGOCALCIFEROL;FOLIC ACID;NICOTINAMIDE;PANTHENOL;RETINOL;RIBOFLAVIN;THI

Current Illness:

ID: 1276976
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 05/01/2021
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: his 2nd Pfizer COVID19 vaccine today and is asking if it would be okay for him to get vaccinated today after being cleared from quarantine last Saturday because he had COVID; his 2nd Pfizer COVID19 vaccine today and is asking if it would be okay for him to get vaccinated today after being cleared from quarantine last Saturday because he had COVID; This is a spontaneous report from a Pfizer-sponsored program via medical information team. A contactable consumer (patient) reported that a male patient of unknown age received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: unknown), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunisation. Medical history and concomitant medication were not reported. On an unknown date patient was diagnosed with COVID and he was enquiring that he was scheduled for his 2nd Pfizer COVID19 vaccine today and was asking if it would be okay for him to get vaccinated today after being cleared from quarantine last Saturday. Outcome for the events was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1276977
Sex: F
Age:
State:

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

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

Lab Data:

Allergies:

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

Symptoms: She got the first one and then she got Covid.; She got the first one and then she got Covid.; This is a spontaneous report from a contactable consumer (reported for her aunt). A 74-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection) dose 1 via an unspecified route of administration on an unspecified date (Lot number and expiry date was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced got the first one and then she got COVID. She said that she had registered her aunt to get that vaccine. She asked, what does she do about her second dose. Caller thinks that, the patient was still having the symptoms. The patient was scheduled for the 16th. Caller asked that, would she contact pharmacy to reschedule. The patient underwent lab tests and procedures which included sars-cov-2 test: positive. The outcome of the events were unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1276978
Sex: F
Age:
State:

Vax Date: 04/01/2021
Onset Date:
Rec V Date: 05/01/2021
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: she had a little infection in her root canal; This is a spontaneous report from a contactable consumer reported for herself. A 60-years-old female patient received first dose of (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: unknown) via an unspecified route of administration on 01Apr2021 as SINGLE DOSE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient stated she received the first dose of the vaccine on 01Apr2021 and is scheduled for her second dose on 22Apr2021. She stated she had a routine dental visit and approximately on unknown date in 2021, found out she had a little infection in her root canal, and they are going to need to do a root canal. This was scheduled after the first shot. She wanted to know if it is safe or if she had this procedure before her second dose. She stated he is trying to schedule it after the second dose of the vaccine, but she wants it done as soon as possible. She asked if she should have this done before or after the vaccine. No PQC present. The outcome of event was unknown. No follow-up attempts are possible. Information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1276979
Sex: F
Age:
State: PA

Vax Date: 03/18/2021
Onset Date: 03/18/2021
Rec V Date: 05/01/2021
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: Anaphylactic reaction immediately after vaccination; This is a spontaneous report from a contactable consumer (patient). A 22-year-old non-pregnant female patient received the first dose of BNT162B2 (BNT162B2; Batch/Lot number was not reported), via an unspecified route of administration, administered in right arm on 18Mar2021 16:00 at single dose for COVID-19 immunization. The patient's medical history included asthma, known allergies to legumes, soy, egg, and tree nuts. The patient's concomitant medications were not reported. The facility type vaccine was hospital. The patient had no other vaccine in four weeks. The patient experienced anaphylactic reaction immediately after vaccination on 18Mar2021 16:00. The event resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care visit. Therapeutic measures were taken as a result of the event and included treatment with Epi pen injection. The patient had no COVID prior vaccination and has not been tested for COVID post vaccination. The outcome of the event was recovered on an unspecified date. Information about lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1276980
Sex: F
Age:
State: NY

Vax Date: 03/28/2021
Onset Date: 04/01/2021
Rec V Date: 05/01/2021
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: feel sick; she began to feel sick and got tested and she also tested positive on April 1st; This is a spontaneous report from a contactable consumer (grandfather) via medical information team. A 19-year-old female patient was administered with first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown,), via an unspecified route of administration on 28Mar2021 as a single dose for COVID-19 immunization. A few days later someone she works with tested positive for Covid, she began to feel sick and got tested and she also tested positive on 01Apr2021 and It was reported that, now patient was feeling much better and her second vaccine dose was scheduled on 18Apr2021. He asked, can she go as planned to get her second dose or does she have to wait since she had covid. Outcome of the events was unknown. Information about lot and batch number was requested.

Other Meds:

Current Illness:

ID: 1276981
Sex: F
Age:
State: PA

Vax Date: 04/08/2021
Onset Date: 04/08/2021
Rec V Date: 05/01/2021
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: diarrhea real bad; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 08Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included constipation (had planned to take a stool softener) and maybe deaf or hard of hearing. The patient's concomitant medications were not reported. Right after the shot on 08Apr2021, patient almost did not make it to the bathroom. She had diarrhea real bad, off and on, that whole day for about 3 hours and was fine after that. Outcome of the event was recovered on 08Apr2021. The reporter considered the event non-serious. No follow-up attempts are completed. Information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1276982
Sex: M
Age:
State: IL

Vax Date:
Onset Date:
Rec V Date: 05/01/2021
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: I have taken both shots./ I am in an isolated room for 14 days.; asymptomatic, but came up with a positive reading; This is a spontaneous report from a contactable consumer (patient) via a Pfizer sponsored program. An 84-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first (Batch/Lot number was not reported) and second dose (Batch/Lot number was not reported); both via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient reported that he have taken both shots, his temp range has been between 97.2 to 98.4 and was asymptomatic, but came up with a positive reading. He was in an isolated room for 14 days. The patient underwent lab tests and procedures which included body temperature: between 97.2 to 98.4 and SARS-CoV-2 test: positive both on unspecified dates. The outcome of the events was unknown.

Other Meds:

Current Illness:

ID: 1276983
Sex: M
Age:
State: FL

Vax Date: 03/26/2021
Onset Date:
Rec V Date: 05/01/2021
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: diagnosed with Covid 19/tested positive for Covid-19; diagnosed with Covid 19/tested positive for Covid-19; This is a spontaneous report from a contactable consumer (Patient). A male patient of an unspecified age (Age: 62 Unit: Unspecified) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), dose 1st via an unspecified route of administration on 26Mar2021 as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient tested positive for covid-19 (drug ineffective) on an unspecified date. It was reported that the patient called in to ask if he can still get his second dose of the vaccine. He got his first dose last 26Mar2021. Second dose is scheduled on 17Apr2021. The patient underwent lab tests and procedures which included sars-cov-2 test: positive. The outcome of the event was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1276984
Sex: F
Age:
State:

Vax Date:
Onset Date: 04/03/2021
Rec V Date: 05/01/2021
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: memory issue; Got covid; Got covid; This is a spontaneous report from a non-contactable consumer. A 59-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunization. The patients medical history and concomitant medications were not reported. On unspecified date, the patient was diagnosed with COVID and she just got out of hospital before day. The reason why the patient called was she was supposed to take the second dose next day. The patient was still under quarantine and her brother was supposed to get the shot. The patient cannot take him. The patient brother stayed with her cousin and he wanted to take the second shot. The patient was not underage but had some memory issues. The patients brother needed someone to be with him. 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: 1276985
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 05/01/2021
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: sore arm; This is a spontaneous report from a contactable consumer. A 61-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history was and concomitant medications were not reported. The patient experienced sore arm on an unspecified date. Outcome of event was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021406291 same patient, different event in seperate vaccine

Other Meds:

Current Illness:

ID: 1276986
Sex: F
Age:
State:

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

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

Lab Data:

Allergies:

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

Symptoms: she developed symptoms and tested positive; This is a spontaneous report received from a contactable consumer (patient's friend). A 54-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection and Lot Number: UNKNOWN) via an unspecified route of administration on an unspecified date (reported as a couple of weeks ago) as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date the patient developed symptoms and tested positive for COVID. He enquired if my friend would have the 2nd dose on later than 21 days, will it have the same effectiveness. she already completed her isolation and showed no symptoms at all. He wants to confirm if the patient can now have the 2nd dose on the scheduled appointment which is 21 days after since her primary care physician advised her to wait until she completely recovered and have the 2nd dose in between 21 and 42 days. The pharmacist told her that she can have the 2nd dose on the scheduled appointment which is 21 days. He says she scheduled the vaccine, and a major medical center are saying to wait the 90 days before the vaccine, she was not sure if she should get the second dose to start over. The outcome of the event was recovered. Information on lot/ batch number has been requested.

Other Meds:

Current Illness:

ID: 1276987
Sex: M
Age:
State: NY

Vax Date:
Onset Date:
Rec V Date: 05/01/2021
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: he tested positive for covid; he tested positive for covid; This is a spontaneous report from a contactable consumer (parent) via Pfizer sponsored program . A 35-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot and expiry date not provided) via an unspecified route of administration on an unspecified date in 2021 (reported as 3.5 weeks ago) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. On an unspecified date in 2021, patient tested positive for covid. Reporter believes that her son had an exposure with Covid before the 1st dose. Patient just finished the 10day quarantine today and scheduled to have the 2nd dose tomorrow (i.e., 14Apr2021). Reporter would like to know if her son should still proceed with the 2nd dose as scheduled because she believes that her son should not get too many antibodies, since the 1st dose was given almost 3weeks ago. Outcome for the events were unknown. Information on lot number/batch number has been requested.

Other Meds:

Current Illness:

ID: 1276988
Sex: F
Age:
State: CA

Vax Date: 04/08/2021
Onset Date: 04/08/2021
Rec V Date: 05/01/2021
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: My bones feel like they are exploding; stabbing pains; brain fog; Involuntary muscle movements; joint/muscle pain; joint/muscle pain; fever chills; hypersensitivity to skin; muscle weakness; migraine; skin burning; rashes; hives; muscles spasms; Dose: 1 Start date: 22Mar2021; Dose: 2 Start date: 08Apr2021; Dose: 1 Start date: 22Mar2021; Dose: 2 Start date: 08Apr2021; This is a spontaneous report from a contactable consumer (patient). A 34-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EP6955, expiration date was not reported), via an unspecified route of administration, administered in the left arm on 08Apr2021 12:30 at single dose for covid-19 immunisation. Medical history included tachycardia, depression, migraines. Concomitant medications included escitalopram oxalate (LEXAPRO); metoprolol tartrate; clarithromycin (CLARITIN [CLARITHROMYCIN]); topiramate. The patient previously took vicodin and experienced hypersensitivity (known allergies), first dose of bnt162b2 on 22Mar2021 04:00 pm (lot number: EN6207, expiration date was not reported) for covid-19 immunisation. On 08Apr2021 at 14:00, the patient experienced involuntary muscle movements, stabbing pains, joint/muscle pain, brain fog, fever chills, hypersensitivity to skin, muscle weakness, migraine, skin burning, rashes, hives, muscles spasms. This has been the most painful experience of my life and it still isn't over. It gets a little better each day but is still just so painful. I can't believe a vaccine can make someone feel this way. My bones feel like they are exploding. No treatment was given in response to the events. No prior covid vaccination. Not tested for covid post vaccination. Outcome of the events was unknown.

Other Meds: LEXAPRO; METOPROLOL TARTRATE; CLARITIN [CLARITHROMYCIN]; TOPIRAMATE

Current Illness:

ID: 1276989
Sex: M
Age:
State: TX

Vax Date: 03/09/2021
Onset Date: 03/23/2021
Rec V Date: 05/01/2021
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: Received his first shot of the Pfizer Covid-19 vaccine on 09Mar2021 and his second dose was scheduled for 30Mar2021, but on 23Mar2021 he tested positive for COVID-19; Received his first shot of the Pfizer Covid-19 vaccine on 09Mar2021 and his second dose was scheduled for 30Mar2021, but on 23Mar2021 he tested positive for COVID-19; Started to feel ill; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 67-year-old male patient received first dose of BNT162B2, (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot Number and expiration date were unknown) via an unspecified route of administration in left arm on 09Mar2021 14:45 (age at vaccination 67 years old) at single dose for COVID-19 immunisation at pharmacy. There was no medical history, no relevant family history and concomitant medication. There were no other vaccines in four weeks and no AEs following prior vaccinations. There was no history of previous immunizations 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 were no additional vaccines administered on same date of the Pfizer Suspect. The patient stated that he received his first shot of the Pfizer Covid-19 vaccine on 09Mar2021, and his second dose was scheduled for 30Mar2021, but on Tuesday 23Mar2021 he felt ill and had a Covid 19 test on 23Mar2021 17:00 which was positive and was quarantined for 12 to 15 days. He would like to know if he should schedule his second dose. Has been over 3 weeks since first vaccination; hasn't gotten second yet. He took 10-12 days off an away from everyone. He was supposed to have his second vaccine on 30Mar2021, but he was still on quarantine for 2 more days at that time. The patient stated that he was trying to reschedule his second vaccine and wanted to know if that was the right thing to be doing. The patient also stated that since it was beyond the 3 weeks period from his first one, he wants to make sure whether he was doing the right thing by scheduling his second one for tomorrow. The patient stated that he had no issues after the vaccine and states that the illness was not that bad for him. Reporter states that he just needs to confirm his appointment online and he can get his vaccination tomorrow at 14:45. The patient also said since it was beyond the 3 weeks from his first vaccine, he just wants to make sure he was doing the right thing. The patient did not visit emergency room or physician office, states he only spoke on the phone with his doctor after his positive test. The report is not related to a study program. Patient did not have lot number as he was at work and does not have his card. Also states he thought he took a picture of it on his phone but he didn't. The outcome of events was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1276990
Sex: F
Age:
State: NJ

Vax Date: 03/27/2021
Onset Date: 03/27/2021
Rec V Date: 05/01/2021
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: pain/arm pain; shakiness of left arm; This is a spontaneous report from a contactable pharmacist. A 31-year-old female patient (not pregnant at the time of vaccination) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via intramuscular on 27Mar2021 on the left arm as single dose for COVID-19 immunization. Medical history included irregular menses, low thyroid, high prolactin. No allergies to medications, food, or other products. There were no concomitant medications, no other medications the patient received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient did not diagnose with COVID-19. Since the vaccination, the patient did not test for COVID-19. On 27Mar2021, patient experienced pain and shakiness of left arm within a few minutes after the shot. The shakiness lasted for about 15 minutes then went away. The arm pain lasted for about 1 day then stopped. There was no treatment received for the adverse event. The outcome of events was recovered on unspecified date. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1276991
Sex: F
Age:
State: KY

Vax Date: 04/01/2021
Onset Date: 04/06/2021
Rec V Date: 05/01/2021
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: She got the first dose on 01APR2021.She tested positive to COVID-19 on 06APR2021.; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided) via an unspecified route of administration on 01Apr2021 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient got the first dose on 01Apr2021. She tested positive to COVID-19 on 06Apr2021. The next dose is scheduled on 25Apr2021. She wanted to know if she should still get the dose on the scheduled date or she should wait for a specific time. The outcome of the event was unknown. The event was assessed as non-serious. Information about lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1276992
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 05/01/2021
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: He got COVID19 after his first shot; He got COVID19 after his first shot; This is a spontaneous report from a contactable pharmacist via a Medical information team. A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: unknown), via an unspecified route of administration on an unspecified date as SINGLE DOSE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient got COVID19 after his first shot, followed by an antibody therapy. He has to wait 90 days before getting his second shot. Seriousness of the events was considered as medically significant. The outcome of events was unknown. Information about lot/batch has been requested.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product BNT162B2 or comirnaty to the reported event Drug ineffective and covid-19 cannot be ruled out.But also consider relevant medical history and concomitant drug history.

Other Meds:

Current Illness:

ID: 1276993
Sex: F
Age:
State: MO

Vax Date: 03/26/2021
Onset Date:
Rec V Date: 05/01/2021
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: wife just tested positive for COVID-19; wife just tested positive for COVID-19; cough; congested head; sinus infection; yellow mucus; This is a spontaneous report from a contactable consumer(patient's husband). An 82-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, (Batch/Lot number was not reported), first dose via an unspecified route of administration on 26Mar2021 as SINGLE DOSE for covid-19 immunization. Patient medical history and concomitant medications were not reported. On an unspecified date the reporter stated that his wife just tested positive for COVID-19. Second dose will be on 16Apr2021. He would like to know if she is still able to get it. He reports that the only symptoms she has are cough, "congested head", feels like a sinus infection, and "spitting out" yellow mucus. The patient underwent lab tests and procedures which included sars-cov-2 test: tested positive on an unspecified date. Outcome of the events was unknown. Follow-up (12Apr2021): This is a follow-up spontaneous report. No new information received. Information about lot/batch has been requested.

Other Meds:

Current Illness:

ID: 1276994
Sex: F
Age:
State: GA

Vax Date: 03/23/2021
Onset Date: 04/05/2021
Rec V Date: 05/01/2021
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: she received her first dose of the Pfizer COVID-19 vaccine on 23Mar2021 and last Wednesday she tested positive for COVID-19; she received her first dose of the Pfizer COVID-19 vaccine on 23Mar2021 and last Wednesday she tested positive for COVID-19; This is a spontaneous report from a contactable consumer (patient) via Pfizer-sponsored program COVAX US Support. A 49-Year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EN6207), via an unspecified route of administration in upper left arm on 23Mar2021 at 13:15at single dose for COVID-19 immunization. Patient took covid vaccine because she was immunocompromised and wanted to get vaccinated. The patient had medical history of immunocompromisation. The patient did not received other vaccine in four weeks. Concomitant medications were not reported. the patient had unspecified chronic medical condition. On 05Apr2021, patient tested positive for COVID-19 and got result on Wednesday 07Apr2021.The patient stated she has a chronic medical condition but that is does not effect weather or not she tested positive. Her second dose is scheduled for tomorrow, 13Apr2021, however her healthcare professional told her to wait for 10 days after the symptoms subside. She wants clarification on whether or not she will need to restart the vaccination series if she reschedules her second dose for a later date. It was further reported that her doctor that since her quarantine period is not up tomorrow she was told to wait until her 14 day quarantine is over to get her second dose which is 2 or 3 days more. Patient asked will this effect her getting it a few days late or will she have to start the process over. The patient also stated that her mother tested positive for COVID-19 after being vaccinated with the Pfizer COVID-19 vaccine and this happened about a month after her second dose. The patient states that she filed a report for herself, however, she did not file an official report for her mother. She did confirm that she told DSU about her mother's AE. The patient asks when should I test for COVID-19 again to make sure I'm negative? I have upcoming tests that I have to complete and they require me to have a negative COVID-19 test before I can complete them. The patient further states, I guess your vaccine is not providing as much protection as you thought since my mom got COVID after being fully vaccinated with the Pfizer Covid vaccine for a month. Patient declined to provide email address as she is not good at checking it. The outcome of the events was unknown.

Other Meds:

Current Illness:

ID: 1276996
Sex: M
Age:
State: CT

Vax Date: 04/01/2021
Onset Date: 04/08/2021
Rec V Date: 05/01/2021
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: Fatigue/tiredness; cough; head cold; congestion; arm pain; This is a spontaneous report from a contactable consumer reported for himself. A 50-years-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in arm right on 01Apr2021 11:45 as single dose for COVID-19 immunisation. Medical history included diabetes mellitus. No known allergies. Concomitant medications included metformin 500 mg, amlodipine besilate (NORVASC) 2.5 mg. The patient experienced fatigue, cough, head cold, congestion, tiredness, arm pain on 08Apr2021 (also reported that on the 4Apr2021 was when the symptoms started), that lasted 24 hours, no treatment received for the adverse events. The events were reported as non-serious. Prior to vaccination, the patient did not diagnose with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Outcome of the events was recovering. The patient became aware that it may have to do with the vaccine and not with his seasonal allergies on the 11Apr2021. No follow-up attempts are needed. No further information is expected.

Other Meds: METFORMIN; NORVASC

Current Illness:

ID: 1276997
Sex: M
Age:
State: MI

Vax Date: 01/13/2021
Onset Date: 04/12/2021
Rec V Date: 05/01/2021
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: tested positive for COVID-19; tested positive for COVID-19; This is a spontaneous report from a contactable Pfizer colleague (patient) or other non-healthcare professional and other non-HCP via Medical Information Team. A 48-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot : EL3248; Expiration Date: Apr2021) via an unspecified route of administration in left arm on 13Jan2021 09:00 and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE mRNA, Solution for injection, Lot : EL3248; Expiration Date: Apr2021) via an unspecified route of administration in left arm on 02Feb2021 06:30 both as single dose for covid-19 immunization. The patient was 48-years-old at the time of vaccination. Medical history included blood pressure. Concomitant medication(s) included Norvasc 10mg daily for blood pressure and was ongoing. On 12Apr2021, patient experienced tested positive for COVID-19. On 12Apr2021, patient underwent lab tests and procedures which included sars-cov-2 test: positive. Outcome of the event was unknown. Follow-up (12Apr2021): New information received from the same Pfizer colleague which included: patient details, start date of event, suspect vaccine information and concomitant medication.

Other Meds: NORVASC

Current Illness:

ID: 1276998
Sex: F
Age:
State: MS

Vax Date: 04/08/2021
Onset Date: 04/08/2021
Rec V Date: 05/01/2021
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: she felt fatigue which she still feels today; This is a spontaneous report from a contactable consumer (Patient). A 73-years-old female patient received bnt162b2 (Formulation: Solution for injection), dose 1 via an unspecified route of administration on 08Apr2021 as SINGLE DOSE for covid-19 immunisation. Medical history included chronic obstructive pulmonary disease from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient experienced she felt fatigue which she still feels today on 08Apr2021. On 08Apr2021 was her first dose of the covid vaccine. Within 3-4 hours she started experiencing fatigue and still has it as of 12Apr2021. She is wondering if she should still get the second dose. The outcome of the event was not resolved. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1276999
Sex: M
Age:
State: NV

Vax Date: 01/28/2021
Onset Date:
Rec V Date: 05/01/2021
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: does not believe it was effective/I don't think the first one was even working; supposed to be in the deltoid and if it is not in the muscle and is in the subcutaneous fat; his arm was a little sore where the needle went in; it was administered into the muscle and it was administered into the fatty portion of my arm and the shot was administered too quickly; This is a spontaneous report from a contactable consumer reported for himself. A 72-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown, Expiry date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on 28Jan2021 (at the age of 72-year-old) at a single dose for covid-19 immunisation. Medical history and concomitant medication were not reported. The patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown, Expiry date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on 18Feb2021 (age at vaccination was unknown) at a single dose for covid-19 immunisation. He received both Pfizer vaccines. The first one on 28Jan2021 and second one on 18Feb2021. The reporter stated that he believed the first shot was not administered correctly because of the way it was done. He watched them inject the solution and stated that it was supposed to be in the deltoid and if it was not in the muscle and was in the subcutaneous fat it will not be effective, and he did not believe it was effective. He stated that he thinks the first shot may have not been administered correctly and he didn't think that he had got the effect of the vaccine like it should be. He didn't have any side effects. He didn't think the first one was even working because he didn't think it was administered correctly, he didn't think it was administered into the muscle and it was administered into the fatty portion of his arm and the shot was administered too quickly. It was way too fast and did not believe they could have put anything in. He received this in (State) and it was administered in a high school where there were no people in there other than the national guard and the people bringing it in and making sure it was mixed and at the right temperature. The person who administered it may not have been well-trained so they may have put it in too fast. He stated the second dose was done nicely. He stated he had no other side effects other than his arm was a little sore where the needle went in. He asked whether he could get a third shot to make up for the first one that did not work. Now he watched people getting the vaccine on TV in other places and they seem to take little bit of time to inject it. This was just like in and out so fast. The second one was great. He asked so, if he get a third shot, is it dangerous or will that be okay. The reporter wanted to know if it is safe if he receives a third dose of the vaccine because he thinks the first one does not count, so it would be like getting 2 doses. He stated he already checked with a medical provider and they don't have any knowledge of how to use it. He also contacted the CDC. He tried to contact the Chief Medical Officer of Pfizer, but he is no longer the chief medical officer. After a verbal response was provided, he stated he is just going to get the third dose and will tell them if he dies, they should just call us but then said he was kidding. He said he can sign up for the vaccine, it is very easy, he just has to say he is getting his first shot. The reporter stated it is really frustrating to not be able to get studies done on this [a need for a third dose if a first dose is invalid]. He stated, since he couldn't get any info ourselves, he guess he will have to be the guinea pig. He stated you can always pass this on to the higher ups. He wanted to know if a third dose would be safe to get or if it would potentially kill him. The reporter stated that J&J stopped giving their vaccine because they are having so many people coming down with adverse side effects. They were trying to keep up with Pfizer and Moderna and came out with it too quickly. Limited information was available over the call. Information on the lot/batch number has been requested. Follow-up (12Apr2021): New information received from a contactable consumer in response to Non-HCP letter sent to consumer included: Updated the clinical details.

Other Meds:

Current Illness:

ID: 1277000
Sex: F
Age:
State: FL

Vax Date: 03/26/2021
Onset Date: 04/01/2021
Rec V Date: 05/01/2021
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: started experiencing all the symptoms last week Wednesday and tested positive; started experiencing all the symptoms last week Wednesday and tested positive; This is a spontaneous report from a contactable consumer (patient). This (Age: 55; Unit: unknown) female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIOTECH-COVID-19 VACCINE, Solution for injection, Batch/Lot number and expiry was not reported), via an unspecified route of administration on 26Mar2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in Apr2021, the patient started experiencing all the symptoms last week Wednesday and tested positive yesterday (11Apr2021) or today (12Apr2021) with lab test sars-cov-2 test. Second dose was scheduled for this Friday and she would like to know whether she could get the 2nd dose of the covid vaccine as she has tested positive for covid or whether she would need to start the vaccination series again if she was unable to get the 2nd dose of the covid vaccine as scheduled. And she was suggesting that they need to put something happier on hold music because she already felt like she was dying. The outcome of started experiencing all the symptoms last week Wednesday and tested positive was unknown. Information about the Lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1277001
Sex: M
Age:
State: FL

Vax Date: 04/09/2021
Onset Date:
Rec V Date: 05/01/2021
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: pain on the injection site; he states that the vaccination provider squeezed the area where he received the second dose; This is a spontaneous report from a contactable consumer . A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in Arm on 09Apr2021 (Lot number was not reported) as single dose for covid-19 immunisation.The patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number was not reported) via an unspecified route of administration, on an unspecified date as single dose for covid-19 immunisation. He said when he got the 2nd dose, the one who injected the vaccine squeezed his arm. He reported that the arm should not be squeezed if the vaccine will be administered, he wants to know if that's true and if there would be a problem with the vaccine administered since his arm was squeezed and reported that the 2nd dose seems to have no effect. He said he felt the needle when it was administered, but he only felt a little pain on the injection site, but no other side effects. He wants to confirm if he really got the 2nd dose of the vaccine. On an unspecified date, the patient experienced pain on the injection site and he states that the vaccination provider squeezed the area where he received the second dose. Outcome of the events was unknown. No Follow-up attempts are needed. Information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1277002
Sex: M
Age:
State: NY

Vax Date: 04/09/2021
Onset Date: 04/10/2021
Rec V Date: 05/01/2021
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: Headache; Fatigue; This is a spontaneous report from a non-contactable consumer (patient). This 34-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in left arm on 09Apr2021 (Lot Number: EP6955) as single dose for COVID-19 immunization. Medical history included Pencillin allergy. The patient's concomitant medication was none. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EP6955) on left arm on 19Mar2021 (at age of 34-year-old) for covid-19 immunization, took codeine and experienced allergies. The patient experienced headache and fatigue on 10Apr2021. The patient had no covid prior vaccination, and no covid tested post vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There was no treatment received for the adverse event. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of event headache was recovered on 12Apr2021, of event fatigue was recovered on an unspecified date. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1277003
Sex: F
Age:
State: NY

Vax Date: 03/11/2021
Onset Date: 03/11/2021
Rec V Date: 05/01/2021
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: Feeling faint; tingling of tongue; numbness left side face; heart racing; red blotchy rash on chest; unusual high blood pressure; headache; This is a spontaneous report from a contactable consumer (patient). A 63-year-old non-pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN6204), via an unspecified route of administration, administered in left arm on 11Mar2021 08:30 as single dose for COVID-19 immunization in an unspecified facility. Medical history included Shingles from Aug2020, mild lymphedemia legs, mild arthritis, and history of stroke from an unknown date. The patient had no known allergies, no COVID prior to vaccination, and has not been tested for COVID post vaccination. The patient has not received other vaccine in four weeks. The patient's concomitant medication includes an unspecified medication taken in two weeks. On 11Mar2021 8:45 am, immediately following injection, the patient experienced feeling faint, tingling of tongue, numbness left side face, heart racing, red blotchy rash on chest, unusual high blood pressure, and a 5-day headache. No treatment was given. The outcome of the events was reported as recovered.

Other Meds:

Current Illness:

ID: 1277004
Sex: F
Age:
State: CA

Vax Date: 04/02/2021
Onset Date: 04/02/2021
Rec V Date: 05/01/2021
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: disoriented; confusion; weak/lack energy; facial and tongue numbness; facial and tongue numbness; dizzy and light headed; This is a spontaneous report from a contactable other HCP. A 63-year-old female patient (pregnant no) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in left arm on 02Apr2021 11:00 (Lot Number: EW0151) as single dose for COVID-19 immunization. Medical history included hypothyroid (long standing with no new meds), allergies to nkda. Concomitant medication included levothyroxine sodium (SYNTHYROID). On 02Apr2021 11:15 am, the patient felt disoriented, confusion, weak, facial and tongue numbness, dizzy and light headed, lack energy lasted 10 days. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events resulted in doctor or other healthcare professional office/clinic visit. There was no treatment received for the adverse event. The outcome of the events was recovered on 12Apr2021. No follow-up attempts are needed. No further information is expected.

Other Meds: SYNTHYROID

Current Illness:

ID: 1277005
Sex: M
Age:
State:

Vax Date: 04/12/2021
Onset Date:
Rec V Date: 05/01/2021
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: stated that his friends father got covid three weeks after the first dose of vaccine; stated that his friends father got covid three weeks after the first dose of vaccine; This is a spontaneous report from a contactable physician reported for a patient. An male patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry dates were not provided), via an unspecified route of administration, on 12Apr2021, 19:09:26 , as a single dose for COVID-19 immunization. Patient medical history and concomitant medications were not provided. Physician was reported that his friends father got covid three weeks after the first dose of vaccine. Patient underwent lab tests and procedure SARS-CoV-2 test (positive). Outcome of the events were unknown. Information about Lot/Batch number is requested.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event and the suspect drug.

Other Meds:

Current Illness:

ID: 1277006
Sex: F
Age:
State: MO

Vax Date: 03/22/2021
Onset Date: 04/12/2021
Rec V Date: 05/01/2021
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: Caller found out she tested positive for COVID-19; Caller found out she tested positive for COVID-19; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program. A 20-years-old female patient 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 22Mar2021, as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. On 12Apr2021 the patient experienced she tested positive for covid-19. she asked if she can still get the second dose of the vaccine. She took first dose on 22Mar2021 and scheduled to take the 2nd dose 12Apr2021 but she was tested covid 19 positive. She was asking if she can take the 2nd dose today. The patient underwent lab tests and procedures which included COVID-19 test positive on 12Apr2021. The clinical outcome of the event was unknown. Follow up (12Apr2021): This follow up report contains no new medically significant safety information. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1277007
Sex: M
Age:
State: MA

Vax Date: 03/01/2021
Onset Date: 04/05/2021
Rec V Date: 05/01/2021
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: Diagnosed with COVID-19; Diagnosed with COVID-19; Nausea; Tired; Unable to eat; Diarrhea; This is a spontaneous report from a contactable consumer. An 80-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 08Feb2021 (15:15) (Lot number: EM9809; Expiration date was not reported) and the second dose on 01Mar2021 (Lot number: EN6203; Expiration date was not reported), both on the right arm as a single dose, with route of administration unspecified, for COVID-19 immunization at the pharmacy/drug store. Medical history included myasthenia gravis and diabetes. The patient had unspecified concomitant medications. On 05Apr2021, the patient had nausea; was tired; unable to eat; and had diarrhea. On 10Apr2021, the patient was diagnosed with COVID-19 (tested positive for SARS COV-2 RT-PCR nasal swab). The events had resulted into doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the reported events. The patient's computerized tomogram (CT) value was 16.1-33.0 on an unspecified date. The outcome of the events was not recovered.

Other Meds:

Current Illness:

ID: 1277008
Sex: F
Age:
State: CT

Vax Date:
Onset Date: 04/03/2021
Rec V Date: 05/01/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Pain in extremity

Symptoms: Excessive Menstrual bleeding with period after 1st vaccination; This is a spontaneous report from a contactable consumer. A 42-year-old female patient (pregnant no) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), at age of 42-year-old, dose 1 via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. Medical history included covid. The patient's concomitant medications were not reported. There was no other vaccine in four weeks. The patient had covid prior vaccination. No covid tested post vaccination. No known allergies and no other medical history. The patient experienced excessive menstrual bleeding with period after 1st vaccination on 03Apr2021. There was no treatment for the event. The outcome of the event was recovered on an unspecified date in 2021. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1277009
Sex: M
Age:
State: NM

Vax Date: 04/05/2021
Onset Date: 04/08/2021
Rec V Date: 05/01/2021
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: hives all over; This is a spontaneous report received from a contactable consumer (patient's wife). A 38-year-old male patient received the 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EP6955, expiration date: 30Jun2021) via an unspecified route of administration in the arm right on 05Apr2021 11:16 AM as a single dose for covid-19 immunisation. Medical history included ongoing asthma since he was born and eye surgery from 05Mar2021. Concomitant medications included prednisolone acetate from 05Mar2021 after eye surgery. The patient previously received (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6202, expiration date: Jun2021) on 15Mar2021 11:16 AM at 38 years old for covid-19 immunisation. The patient received his second Covid 19 vaccine on 05Apr2021 and the hives started on 08Apr2021. The patient had hives all over. The hives did get worse overnight. The patient had gotten hives when he was younger but it was a reaction to a plant. The hives he had currently have not gone away even with a shower or taking Benadryl. He took 2 25mg tablets of Benadryl within an hour of each other yesterday, 08Apr2021. Then about 9 hours later he took 2 more 25mg tablets. He was going to sleep so he thought the Benadryl (lot number: SEF004, expiry date: Dec2021) would help with that. The patient had no questions except if her husband needed to go to the doctor. The AEs did not required a visit to Emergency Room, no physician office. The patient had no Prior Vaccinations (within 4 weeks). Outcome of the events was not recovered. No follow-up attempts are needed. No further information is expected.

Other Meds: PREDNISOLONE ACETATE

Current Illness: Asthma

ID: 1277010
Sex: F
Age:
State: TN

Vax Date: 04/07/2021
Onset Date: 04/08/2021
Rec V Date: 05/01/2021
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: Left side face swelling; This is a spontaneous report from a contactable consumer reported for herself. This 56-year-old female patient received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6207) via an unspecified route of administration in the left arm (reported as "left shoulder") on 07Apr2021 13:00 as a single dose for covid-19 immunisation. Medical history included asthma diagnosed as a child. The patient stated it's not ongoing, it's more during seasonal allergies. She took Singulair to help. Concomitant medications were unknown. The patient had Pfizer covid19 vaccine on Wednesday 07Apr2021 and left side face swelling yesterday on 08Apr2021. It's on the left side of the face. It started around the eye and currently she can feel it running down the side of the face. Left side face swelling was reported as worsened. The patient asked if she would be okay to get the second vaccine. She stated she was not in pain, but was concerned that she won't be able to get the second vaccine. She had not treated the swelling yet, and was not sure if she should see her doctor. She was scheduled for the second dose of the vaccine. The patient had no prior Vaccinations (within 4 weeks). Outcome of the events was not recovered. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1277011
Sex: M
Age:
State: MN

Vax Date: 03/11/2021
Onset Date: 03/01/2021
Rec V Date: 05/01/2021
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: temp to 100; weakness; fatigue; nausea; diarrhea; This is a spontaneous report from a contactable physician, the patient. A 76-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot EN6206, second dose) solution for injection intramuscular in the left arm on 11Mar2021 at 08:20 (at the age of 76-years-old) as a single dose for COVID-19 immunization. Medical history included ongoing blood pressure high from 2010, ongoing high lipid from 1980, and ongoing esophagitis from 1975. Concomitant medications included ongoing atenolol for blood pressure high from 2010, ongoing lisinopril for high blood pressure from 2010, ongoing atorvastatin for high lipids for greater than 10 years, ongoing fenofibrate for high lipid for greater than 10 years, and ongoing lansoprazole (PREVACID) for esophagitis for greater than 10 years. The patient did not receive any other vaccines within four weeks prior to the vaccination. Historical vaccine included BNT162B2 (first dose, lot EL9266) for COVID-19 immunization on 18Feb2021 and experienced headache, nausea, diarrhea, weakness, fatigue, and 99.5 temp (fever). The patient experienced moderate weakness, fatigue, Temp to 100 F, Nausea + diarrhea x2 in Mar2021. Treatment for the event fever included liquid Rx-TYLENOL at 500 mg twice. The outcome of the events weakness, fatigue, Temp to 100, nausea, and diarrhea was unknown. Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Fever 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: ATENOLOL; LISINOPRIL; ATORVASTATIN; FENOFIBRATE; PREVACID

Current Illness: Blood pressure high; Esophagitis; Lipids increased

ID: 1277012
Sex: F
Age:
State: NY

Vax Date:
Onset Date:
Rec V Date: 05/01/2021
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: my lymph nodes on my left side began to swell and now they are both swollen the left and the right and the neck area:; pain in her throat; pain in her ear; felt fatigue for 1 day; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 46-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6207, Expiry date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on an unknown date at a single dose for covid-19 immunisation. The patient historical vaccine included first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6203, Expiry date: unknown), via an unspecified route of administration on 05Mar2021, at single Covid-19 immunization. Patient medical history included breast cancer survivor, blood pressure high and cough. Patient concomitant medications included paracetamol (TYLENOL), candesartan cilexetil, felodipine (ATACAND COMB) taken for High Blood pressure, letrozole (LETROZOLE) taken for cancer it was estrogen blocker, celecoxib (CELEXA [CELECOXIB]) and benzonatate (TESSALON PERLE), all concomitant medications start date stop date was unspecified. After receiving the first dose of the vaccine, she had swollen lymph nodes under her arm pit. After receiving the second dose of the vaccine, she had swollen lymph nodes, pain in her throat, pain in her ear and felt fatigue for 1 day. She took Tylenol for 5 days. She added that last Thursday, her lymph nodes were swollen on both sides. She saw her doctor, Patient underwent lab test and procedure which included ultrasound and told her it was likely due to the vaccine. She mentioned that she is a breast cancer survivor. The patient stated that she is calling because she wanted to report a reaction and she wanted to see if they have heard of those reaction before due to the COVID vaccine, swollen lymph node on the vaccine site. When again probed for the concern, the patient stated that swollen lymph node on the left side and on the right side. She got the vaccine on the left side, but it started on the left side. When paraphrased the above concern, the patient stated that this was a reaction swollen lymph node. It was like her 'neck' and her throat and ear were hurting for like 5 days and then like two weeks after the vaccine her lymph nodes on her left side began to swell and now they are both swollen the left and the right and the neck area. The patient stated that from the next day she had pain in her throat and in her ear and then it lasted for like 5 days. She had pain in her ear and her throat and on last Thursday she does not know what date it was, but it was the first day, on that day she had swollen node on left side like 3 swollen lymph nodes, so she went for ultrasound. She asked whether people have been reporting this as a side effect. The patient added that from the first vaccine she had like node under her armpit hurting, to the first dose. It was painful under the armpits like lymph nodes under the armpits. The outcome of the events was unknown. No follow-up attempts are needed. No further information is expected. Follow up (14Apr2021): New information received from a contactable consumer in response to Non-HCP letter sent to consumer included: Updated the concomitant medications (paracetamol (TYLENOL), candesartan cilexetil, felodipine (ATACAND COMB), letrozole (LETROZOLE), celecoxib (CELEXA [CELECOXIB]) and benzonatate (TESSALON PERLE), medical history (Blood pressure high and cough) and clinical details.

Other Meds: TYLENOL; ATACAND COMB; LETROZOLE; CELEXA [CELECOXIB]; TESSALON PERLE

Current Illness:

ID: 1277013
Sex: F
Age:
State: KS

Vax Date: 03/17/2021
Onset Date: 03/17/2021
Rec V Date: 05/01/2021
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: She had a back ache; Her neck and shoulder ached; Her neck and shoulder ached; This is a spontaneous report received from a contactable consumer (patient). An 80-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm right on 17Mar2021 14:30 as single dose for covid-19 immunisation. Medical history included covid from Nov2020, and lost there sense of taste and smell. The patient's concomitant medications were not reported. The patient experienced she had a back ache, and her neck and shoulder ached on 17Mar2021. The outcome of event back ache was unknown, while other events were recovered on 24Mar2021. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1277014
Sex: M
Age:
State: MN

Vax Date:
Onset Date:
Rec V Date: 05/01/2021
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: Soreness at injection site; This is a spontaneous report from a contactable consumer. A 73 years old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm right on an unspecified date as single dose for covid-19 immunisation. Medical history included high blood pressure. The patient was on high blood pressure medication but is not sure what the name of it was. The patient experienced soreness at injection site on an unspecified date with outcome of unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1277015
Sex: M
Age:
State: PA

Vax Date: 03/13/2021
Onset Date: 04/07/2021
Rec V Date: 05/01/2021
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: not feeling well; This is a spontaneous report from a contactable consumer (patient). A 69-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 13Mar2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient wasn't feeling well on 07Apr2021. The outcome of event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1277016
Sex: F
Age:
State: CA

Vax Date: 03/25/2021
Onset Date: 04/03/2021
Rec V Date: 05/01/2021
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: Ulcers in the back of my mouth; Severe neck pain; This is a spontaneous report from a contactable consumer (patient). A 54-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in the left arm on 25Mar2021 at 13:45 (batch/lot number: EN6208) as a single dose for COVID-19 immunisation. Medical history included hidradenitis suppurativa from 2019 and ongoing (stated it has been about 2 years ago when she was diagnosed), anti-synthetase syndrome from 2020 and ongoing (diagnosed about a year ago, tested positive for an antibody of it), she was disabled from an unknown date and blood pressure (abnormal) from an unknown date. Family history was reported as none. Concomitant medication included mycophenolate mofetil hydrochloride (CELLCEPT) taken for anti-synthetase syndrome from an unspecified start date and ongoing - her rheumatoid doctor told her to get it, she suffered from anti-synthetase syndrome, this was an immune suppressant, she started taking this a few months ago (4-5 months ago), she was on another immune suppressant, but switched to this one. The patient stated she takes other medication for blood pressure, but it was not relevant. No further details provided. The patient received the Pfizer Covid vaccine and wanted to report side effects. She has an autoimmune disease. The symptoms started with severe pain in her neck on 03Apr2021. After that subsided, the back of her mouth broke out into ulcers on 06Apr2021, and it has been there for about 8 days. She was scheduled for the second dose this Wednesday, 14Apr2021. Stated she will get the second dose because she has a severe autoimmune disease. She went to her nose and throat doctor and got medicine for her mouth ulcers. The event mouth ulcers required a visit to the physician's office. Stated she will go for her second vaccine. She wanted to report side effects, and asked should she receive the second vaccine. Vaccination facility type was sports club center. Vaccine administered at military facility reported as no. No prior vaccinations (within 4 weeks). Relevant tests were reported as none. The outcome was recovered on 06Apr2021 for the event "severe neck pain" and not recovered for the event "ulcers in the back of my mouth".

Other Meds: CELLCEPT

Current Illness: Antisynthetase syndrome (Diagnosed about a year ago. Tested positive for an antibody of it.); Hidradenitis suppurativa (States it has been about 2 years ago when she was diagnosed.)

ID: 1277017
Sex: F
Age:
State: TN

Vax Date: 03/19/2021
Onset Date: 03/01/2021
Rec V Date: 05/01/2021
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: Felt like a sunburn or wind burn on head, cheeks, both sides, and upper arms/Face on the right side felt like a sunburn or windburn; face on the right side became numb-like and it went to the other side; right breast was swollen; This is a spontaneous report received from a contactable consumer reported for self. A 69-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration administered in Arm Right on 19Mar2021 (Lot Number: EN620P) as single dose for COVID-19 immunisation. No additional vaccines administered on same date of the Pfizer suspect. Prior vaccinations (within 4 weeks) was none. Medical history included Diabetic from 1995 and ongoing, blood pressure high from 1995 and ongoing (just took her usual medications); eczema from 2014. Family medical history relevant to AEs was none. The patient's concomitant medications were none. Historical vaccine included first dose of BNT162B2 via an unspecified route of administration, administered in Arm Right on 26Feb2021 (Lot Number: EX9266) for COVID-19 immunisation; took the shingles shot and broke out they claimed that she had topical eczema. She thinks it was from the shot. That was in 2014. After the second or third day, her face on the right side became numb-like and it went to the other side on 22Mar2021. And now, on her head and on her body, it felt like a sun burn or wind burn. She took Benadryl and it is not going away. She didn't know if it was from the shot. It started 3 days after she had it on 19Mar2021. It started on the third day in her face and seemed to work its way down. Her right breast was swollen on Mar2021, and her daughter took the shot and got deathly sick, her right side was swollen to 3 times its size on her breast. She didn't swell that much and hers has gone down now. Her arms are really tender like sunburn or wind burn. As long as she is sitting still it doesn't bother her but if her clothes hit it or anything it is annoying. She didn't know if other people have complained about that. The patient stated it hurt on her head, like a sunburn. She said there was no numbness, it was more like a sunburn. It doesn't hurt unless touched, like her bra rubbing against it and agitating it. She didn't have this until she had the shot. She got the shot on 19Mar2021, and about 22Mar2021 it started with her face first. It worked its way down her body. It was about a week later that it spread to other parts of her body. She waited about calling because every day she thought it would be getting better. but it hasn't. she took Benadryl for a sunburn-type feeling on her body and it hasn't helped. She had not received any other treatment. There no AEs require a visit to emergency room or physician office. She had a physical done in between her first and second dose. She had routine bloodwork. Outcome of the event right breast was swollen was recovered, of the other events was not recovered. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness: Blood pressure high; Diabetic

Total 2021 VAERS Injuries: 636,615

Page last modified: 03 October 2021 5:28pm