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: 1439797
Sex: F
Age:
State: WA

Vax Date: 04/13/2021
Onset Date: 04/25/2021
Rec V Date: 07/01/2021
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: a rash all over the body after the 1st dose; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: penmanship is not that great on vaccine card, so unable to tell if LOT number is 6W0153 or GW0153, Expiry date: unknown, age at vaccination: 50-year-old), via an unspecified route of administration in Arm Right on 13Apr2021 17:30 as dose 1, single for covid-19 immunisation administered at Pharmacy. Medical history included ongoing allergic to penicillin (Mother is also allergic to penicillin). The patient does not even take vitamins or over the counter pills or any other medications. The concomitant medications within 4 weeks were not reported. The patient reported, after 2 weeks since getting the shot, has been getting a rash all over her body on 25Apr2021. It is not just the Covid arm, it is all over, the rash. Is asking if she should have the second shot tomorrow since she still has the rash. The patient was treated with Benadryl and was prescribed Prednisone for the rash. The outcome of the event was not recovered. Follow-up attempts are completed; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness: Penicillin allergy (Mother is also allergic to penicillin.)

ID: 1439798
Sex: M
Age:
State:

Vax Date: 04/27/2021
Onset Date:
Rec V Date: 07/01/2021
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: tested positive for covid 19; This is a spontaneous report from a contactable consumer (patient). A 50-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), dose 1 via an unspecified route of administration on 27Apr2021 as first dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. He had first dose of the Pfizer Covid vaccine on 27Apr2021 and then tested positive for covid 19 on 2021. He would have completed quarantine before the day of his second dose on 11May2021. Also asking question was it okay for him to still get his second dose of the vaccine. The patient underwent lab tests and procedures which included sars-cov-2 antibody test: positive on 2021. The outcome of event was unknown.

Other Meds:

Current Illness:

ID: 1439799
Sex: F
Age:
State: OR

Vax Date: 05/01/2021
Onset Date: 05/02/2021
Rec V Date: 07/01/2021
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: stomach cramping; At the site of injection there was bruising and whelps; Bruising on arm; then diarrhea for 6 days and really bad explosive kind; welts and red swollen on arm and then chills and nausea and vomiting and more diarrhea and stomach pain lots.; welts and red swollen on arm and then chills and nausea and vomiting and more diarrhea and stomach pain lots.; welts and red swollen on arm and then chills and nausea and vomiting and more diarrhea and stomach pain lots.; welts and red swollen on arm and then chills and nausea and vomiting and more diarrhea and stomach pain lots.; welts and red swollen on arm and then chills and nausea and vomiting and more diarrhea and stomach pain lots.; welts and red swollen on arm and then chills and nausea and vomiting and more diarrhea and stomach pain lots.; welts and red swollen on arm and then chills and nausea and vomiting and more diarrhea and stomach pain lots.; Tired; I just I feel miserable; it's blowout, it making hard for me to work,; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Left on 01May2021 09:00 (Batch/Lot Number: EW0171) as dose 2, single (at the age of 51-year-old) for covid-19 immunisation. Medical history included anxiety, depression and ocd from an unknown date and unknown if ongoing. The patient previously took codeine for hypersensitivity. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication(s) included duloxetine hydrochloride (CYMBALTA), bupropion hydrochloride (WELLBUTRIN), hydroxyzine hydrochloride (HYDROXIZINE). The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number-ER8732) at left arm on 03Apr2021 09:00 as dose 1, single for covid-19 immunisation. On 02May2021, the patient experienced bruising on arm, then diarrhea for 6 days and really bad explosive kind and then welts and red swollen on arm and then chills and nausea and vomiting and more diarrhea and stomach pain lots. Tired. No fun at all and still dealing with this, 6 days out. Have had to be off work as well. Almost went to er last night. The patient stated she was on day 18 now after the second Pfizer shot, she had for covid and she still have stomach issues and diarrhea a lot of it every single day and she had been tested for every single thing as well as for Covid and she does not have any of that. She also stated that it is like every day, it's blowout, it making hard for me to work, there's lot of days she had to take a off so. She further stated she have had test Influenza A and B, two Covid tests and neurovirus toxin, every test available and nothing was coming back positive. So the first shot was on 03Apr2021. Caller stated she was having a really bad reaction to the Pfizer COVID 19 vaccine. She has extreme diarrhea, stomach cramping, and chills off and on. She has been tested by her doctor and everything has come back negative. She was going to the bathroom every 20 min. Now, within 1/2 to 1 hour after eating she has to go to the bathroom. She was not eating much. She started a heavy-duty antibiotic yesterday. She was taking Imodium. At the site of injection there was bruising and whelps I just I feel miserable. They subsided, but then after a bad bought of diarrhea, on about day 12, the red whelps returned. The adverse event resulted in Doctor or other healthcare professional office/clinic visit. The patient underwent 2 covid tests on 06May2021, Nasal swab tests (a rapid one and one with results in 2 to 4 days), result was negative and another Nasal Swab, result pending. Prior to vaccination, the patient was not diagnosed with COVID-19. The outcome of the events bruising on arm, then diarrhea for 6 days and really bad explosive kind, welts and red swollen on arm and then chills and nausea and vomiting and more diarrhea and stomach pain lots, tired was not recovered and for rest it was unknown. No Follow-up attempts completed. No further information is expected.

Other Meds: CYMBALTA; WELLBUTRIN; HYDROXIZINE

Current Illness:

ID: 1439800
Sex: F
Age:
State: FL

Vax Date: 04/24/2021
Onset Date:
Rec V Date: 07/01/2021
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: arm soreness, arm that received the shot; fatigue; swollen lymph nodes; burning sensation in the left side of the body; chest pain; sever indigestion/severe heartburn; left side of the body just has a weird odd feeling; whole left side of the body is hot; arm started getting hot and sore again; This is a spontaneous report from a contactable consumer (patient). A 64-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EW0153), dose 1 via an unspecified route of administration, administered in arm on 24Apr2021 as single for COVID-19 immunisation. The patient medical history included autoimmune illness. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced arm soreness, arm that received the shot, fatigue, swollen lymph nodes, burning sensation in the left side of the body, chest pain, sever indigestion/severe heartburn, left side of the body just has a weird odd feeling, whole left side of the body is hot, and getting hot and sore again. The patient reported that she had the typical side effects like the sore arm and a little bit of fatigue. About the fifth day after she had severe heartburn and chest pain. She further reported that since the heartburn episode she felt like there was burning down her left side of the body. The arm that received the shot stopped being sore but then about 2 days ago it started getting hot and sore again but there were no bumps or swelling. On the left side of her body, she felt like it was on fire and her lymph nodes were swollen under her arm and her left side of the body just had a weird, odd feeling. She has an autoimmune disease, and she was wondering if that could be why she was having a reaction to the vaccine. The outcome of all the events were unknown. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1439801
Sex: F
Age:
State:

Vax Date: 04/07/2021
Onset Date:
Rec V Date: 07/01/2021
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: cough; chronic diarrhea/Uncontrollable Diarrhea; Itching on back of my head and in front of my arms; hands and muscles aching; swelling; pain; hands and muscles aching; This is a spontaneous report from a contactable reported for unknown patient. A 58-year-old female patient received BNT162B2 (Pfizer-BioNTech Covid-19 Vaccine, Solution for injection, Lot number: Unknown), via an unspecified route of administration on 07Apr2021, as dose 2, single for COVID-19 immunization. The patient's medical history included hearing impairment and smoker, unknown if ongoing. Concomitant medications were not reported. The patient previously received first dose of BNT162B2 (Pfizer-BioNTech Covid-19 Vaccine, Solution for injection, Lot number: Unknown), via an unspecified route of administration on an unspecified date, as single dose for COVID-19 immunization. On an unspecified date, after the second dose of vaccine, the patient experienced cough; but attributed it to smoking, chronic diarrhoea/uncontrollable diarrhoea, itching on back of her head and in front of her arms, hands and muscles aching, swelling, and pain. Patient experienced chronic uncontrollable diarrhoea and every time when she ate or drink something, she had diarrhea afterwards. The patient took Pepto-Bismol for diarrhoea and it did not stop. She tried to eat fruits and everything but became miserable. The clinical outcome of the event diarrhoea was not resolved and clinical outcome of all other events was unknown. No follow-up attempts are needed. information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1439802
Sex: F
Age:
State: NY

Vax Date: 03/31/2021
Onset Date: 04/25/2021
Rec V Date: 07/01/2021
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: Several rashes have developed on the arm of the injection site of the second dose; This is a spontaneous report from a contactable consumer, the patient. A 79-year-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via an unspecified route of administration in left arm on 31Mar2021 at 15 hours as a single dose, for COVID-19 immunisation. Medical history included pre-diabetic. The concomitant medications included metformin (MANUFACTURER UNKNOWN) and atorvastatin (MANUFACTURER UNKNOWN) both for unknown indication. 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 and the patient has not been tested for COVID-19. The patient previously received single dose of Pfizer vaccine in arm Left on 03Mar2021 at 12:45 hours. On 25Apr2021, the patient experienced several rashes that had developed on the arm of the injection site (vaccination site rash) following the second dose. The first sign of the rash had occurred during the week of 25Apr2021 and was still present at the time of this report. The rash had begun with a circular patch around where the shot was given and had spread down the arm which formed a circle around the middle of the forearm. The event had not resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the reported event was not recovered at the time of this report. No follow-up attempts are possible. Information about lot number cannot be obtained.

Other Meds: ATORVASTATIN; METFORMIN

Current Illness:

ID: 1439803
Sex: F
Age:
State: OR

Vax Date: 05/02/2021
Onset Date: 05/06/2021
Rec V Date: 07/01/2021
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: fairly debilitating; can hardly eat; generally feeling unwell; really weak; feels shakey; diarrhea; stomach churning; This is a spontaneous report from a contactable consumer or other non hcp. A 64-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6201), via an unspecified route of administration, administered in Arm Left on 02May2021 at 10:30 or 11:00 am, (at the time of vaccination 64-years-old), as a SINGLE DOSE for COVID-19 immunization. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: ER8737), via an unspecified route of administration, administered in Arm Left on 11Apr2021 (at the time of vaccination 64-years-old), as a SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 06May2021, the patient experienced diarrhea, stomach churning; on 07May2021, really weak, feels shakey; on an unspecified date, fairly debilitating, can hardly eat and generally feeling unwell. Caller has been taking anti-diarrheal Loperamide, 2mg, every day since 06May2021. Patient neither visited to emergency room nor physician office. Patient did not take any vaccine within 4 weeks prior vaccination. The outcome of the events diarrhea, really weak, feels shakey and stomach churning was not recovered and events fairly debilitating, can hardly eat and generally feeling unwell was unknown. No Follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1439804
Sex: M
Age:
State: FL

Vax Date: 04/29/2021
Onset Date: 04/29/2021
Rec V Date: 07/01/2021
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: Congestion; Coughing, described as initially so bad he was collapsing, now a hacking and rattling cough; Fever; Body aches; Diarrhea; stomach pain/Diarrhea, with stomach cramping; Nausea; lack of appetite; Fatigue; Fatigue, kept falling asleep; This is a spontaneous report from a contactable consumer (Patient's mother). A 16-years-old male patient received first dose BNT162B2 (BNT162B2, solution for injection, Batch/Lot Number: EW0171), via an unspecified route of administration, administered in Arm Right on 29Apr2021 09:30 (at the age of 16-year-old) as dose 1, single for covid-19 immunisation. Medical history included migraine from Jul2018 and ongoing, irritable bowel syndrome from Jul2018 and ongoing. Irritable bowel syndrome is constipation, not diarrhea. Concomitant medications included rizatriptan taken for migraine from Jul2018 and ongoing. Patient did not took any other vaccines within 4 weeks, prior covid-19 immunisation. No adverse events following prior vaccinations. On 29Apr2021, the patient experienced congestion, coughing, described as initially so bad he was collapsing, now a hacking and rattling cough, fever, body aches, stomach pain, diarrhea, with stomach cramping, nausea, lack of appetite, fatigue, kept falling asleep. It was reported that caller states he may have inherited this from her. Caller states that (patient) her son had a bad 2018, as they were trying to figure out what was going on with him, medically. Patient had a colonoscopy and endoscopy and Patient was diagnosed with migraines and irritable bowel syndrome at that time. Caller states his issue with irritable bowel syndrome is constipation, not diarrhea. Caller states that she and her son had the Pfizer Covid shot. Caller states that she and her son, had the vaccine, last Thursday, recaptured later in report as 29Apr2021.Caller states her symptoms were not that bad, and reports she still has diarrhea. Caller states that her son, 3 hours after the vaccine, had, reclarified, congestion, cough, fever, body aches, stomach pain, nausea, diarrhea, and fatigue, where he kept falling asleep. Caller reports that her son is 16 years old. Caller states that some of the effects have gone down, but the stomach pain and diarrhea have remained. caller states that because of her son's symptoms, he was tested for the Covid virus, specifically because his cough got so bad, that he was almost collapsing. Caller states he was tested for Covid on Monday, and his test was negative. The main reason she is calling is to get an answer about his symptoms. Caller states that she really can't get an answer from his doctor, as he instructed the Caller if her son's symptoms got bad, to take him to the emergency room. Now mostly his stomach pain and diarrhea remain. Caller states she started giving her son Imodium. Reclarified, Caller asks are there any suggestions for treatment of his diarrhea and stomach pain. Caller asks, how long will they last as it has been over 7 days. Caller states she has been on the internet researching this question. Caller states the doctor recommended giving her son the medication, Imodium, and if in 10 days, it is not resolved, then the doctor will recommend another treatment or further testing for her son. Caller states it is hard to find information online. Caller states her son's Paediatrician is at a loss. Caller agrees to continue a safety report for her son. Cough outcome caller answers as improved, but adds he was coughing so bad that he was collapsing. Caller states the cough is now just a hacking, rattling cough. Time around 11am, fever at noon caller states, Body aches ends caller states roughly on Saturday 01May2021 around noon, stomach pain around noon caller answers as kind of persisting, reclarified as he has spikes of the pain being worse, then it settles down like in the beginning, with moderate pain. Nausea caller states around 11 am, and the nausea came before the stomach pain. caller adds that because of the nausea, her son complains of a lack of appetite, and it came on because of the nausea, and that lack of appetite is still present. Diarrhea caller states at noon, and the diarrhea happened when his stomach started cramping. Caller clarifies that her son started taking the Imodium yesterday, and initially had no results yesterday. Caller reports that today his diarrhea is not as bad, as it was yesterday and Fatigue, kept falling asleep Caller states her son is still sleeping a lot and tired. caller reports probably around noon, and for the first 3 days after the vaccine, he slept, Caller reports he is improved, but still tired, not falling down tired. Investigation included Caller states that he was showing signs of Covid after the first vaccine and she wanted to make sure he did not have the Covid virus. No History of all 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). Patient did not visited emergency room and physician room, Caller reports that she has called her son's doctor, but did not actually see him in person. Caller states that there have been 3 or 4 calls back and forth, between herself and the doctor. Caller notified that Medical Information and/or Pfizer is unable to provide medical advice but may have resources to help answer some questions. Caller verbalized understanding. Second call notification was given as Caller was on speakerphone getting information from her Son, for his report. The patient underwent lab tests and procedures which included sars-cov-1 test: negative on 03May2021, endoscopy, colonoscopy. Therapeutic measures were taken as a result of diarrhea included imodium. The outcome of the events congestion, coughing, described as initially so bad he was collapsing, now a hacking and rattling cough, fatigue, kept falling asleep were recovering, nausea, lack of appetite were recovered with sequel on 01May2021, fever was recovered on 03May2021, body aches was recovered on an unknown date in 2021, diarrhea with stomach cramping was not recovered, and the outcome of the event stomach pain was unknown. No follow-up attempts are needed. No further information is expected.

Other Meds: RIZATRIPTAN

Current Illness: Constipation predominant irritable bowel syndrome (Verbatim: Irritable bowel syndrome Irritable bowel syndrome is constipation, not diarrhea.); Migraine (Verbatim: Migraines)

ID: 1439805
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 07/01/2021
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: Blood clot; This is a spontaneous report from a contactable consumer (patient's friend) via Medical Information Team. A patient of an unspecified age and gender received an unknown dose number of BNT162B2 (COVID-19 Vaccine - Manufacturer Unknown, Formulation: Solution for injection), via an unspecified route, on an unknown date (Batch/Lot Number: unknown) as single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, reporter reported that the patient actually had a blood clot after receiving a COVID Vaccine but did not verify manufacturer of friend's vaccine. The outcome of the event was unknown. Information on lot number/batch number has been requested.

Other Meds:

Current Illness:

ID: 1439806
Sex: F
Age:
State:

Vax Date: 02/01/2021
Onset Date: 02/01/2021
Rec V Date: 07/01/2021
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: she was set back and was sick as a dog for 3-4 days; This is a spontaneous report from a contactable consumer. A 80-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Unknown), via an unspecified route of administration on Feb2021, as dose 1, single for COVID-19 immunisation. The patient's medical history included COVID on an unspecified date in Jan2021, to which she had terrible indigestion and was hospitalized to the hospital for 8 days. Patient's oxygen levels were 91-92, in which she would occasionally get some oxygen to help her breathe. She had tests done for 4 days in the hospital, after which she was discharged upon recovery. Concomitant medications were not reported. The patient's doctor advised to get vaccinated within 3 weeks after recovering from COVID, to which the patient opted for 4 weeks after because she felt it was too soon. Patient was healthy after her recovery. On an unspecified date in Feb2021, after the administration of first dose of vaccine, the patient was set back and was sick as a dog for 3-4 days. Patient recovered from it, but has yet to receive her 2nd dose. Patient was not sure how she could receive it and she believes she has enough antibodies and asked about any test to determine how many antibodies she took and what was the value she was looking for. The patient underwent lab tests and procedures which included oxygen consumption: 91-92 during COVID infection, on Feb2021. The clinical outcome of the event was resolved, on an unspecified date in Feb2021. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1439807
Sex: F
Age:
State: PA

Vax Date: 05/12/2021
Onset Date: 05/12/2021
Rec V Date: 07/01/2021
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: Sore left arm; tiredness; This is a spontaneous report from a contactable consumer (Parent). A 12-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for Injection, Batch/Lot Number: EN5318) via an unspecified route of administration, administered in Left Arm on 12May2021 (at the age of 12-years-old) as Dose 1, Single for COVID-19 immunization. The patient's medical history was not reported. The Concomitant medications included fluticasone propionate (FLONASE [FLUTICASONE PROPIONATE]) loratadine (CLARITINE) vaccine in two weeks. No other vaccine administered in four weeks. No Known allergies were reported. The patient did not test for covid post vaccination. The patient did not suffer from covid prior vaccination. On 12May2021, the patient experienced sore left arm and tiredness. Patient did not received ant treatment. Query included Pfizer Drug safety unit recently received the attached report submitted via pfizersafetyreporting.com. Please help to confirm the date that you became aware of the adverse events in this report as this effects regulatory reporting timelines. This awareness date is the date you became aware of the occurrence of the reported events. If you are the patient in the case, your awareness date would be the date that you became aware you were experiencing the reported events. If you are not the patient in the case, your awareness date would be the date you became aware of the occurrence of the reported events. This awareness date represents the Pfizer receipt date of the report and reflects the earliest date that any Pfizer colleague learned of the adverse event. If you learned of these events from another Pfizer colleague, please provide the date that the first Pfizer colleague became aware of the events reported, as regulatory reporting due dates are calculated based on the first day that a Pfizer colleague became aware of the adverse events. Response received I first became aware of this event on 12May2021. Please let me know if you need anything else. The outcome for the events was recovering.

Other Meds: FLONASE [FLUTICASONE PROPIONATE]; CLARITINE

Current Illness:

ID: 1439808
Sex: M
Age:
State: MI

Vax Date: 03/02/2021
Onset Date:
Rec V Date: 07/01/2021
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: metallic taste and smell; metallic taste and smell/diesel taste and smell; diesel taste and smell; This is a spontaneous report from a contactable consumer (patient himself) via Pfizer. A 68-year-old male patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration in left arm on 02Mar2021 at around 13:00 (as reported) as dose 2, single (at the age of 68-years-old) for COVID-19 immunization. Patient medical history was not reported. The concomitant medications included amitriptyline had been on for 20 years, patient takes as needed because he was in a bad car accident at a dose of 10 mg, butalbital, caffeine, paracetamol (FIORICET), cyclobenzaprine, had been on for 20 years at a dose of 10 mg taken for headache. Historical vaccine included BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration in left arm on 09Feb2021 at around 14:00 (as reported) as dose 1, single for COVID-19 immunization. Patient received both doses of the Pfizer-BioNTech COVID-19 Vaccine (First dose last 09Feb2021 & Second dose on 02Mar2021). He reported to have had a metallic taste and smell, like a diesel engine. Patient mentioned he was unsure when this started but it had been 3 months already. He also stated that he saw a physician, but he still wanted to know if it had been reported. He had an awful taste and smells the same odor. It had been a few months with the metallic taste in his mouth. Patient added that diesel taste and smell started about the time that they got the shots. Patient stated that he did say it was metallic earlier but he would not say it was metallic, he thought that people who do not have experience say it was metallic. He stated it was more like diesel fumes and a bitter taste that he tastes and smells. He did not know when this started but stated that it just stays the same. Patient was asked when symptoms started and he stated he could not really say that. He never thought about it until the last months or so he noticed he had it for a while. He smelled the same odor and taste if that makes any sense because taste and smell are related. Patient added he had never been sick or had any childhood diseases. He wanted to know if it was something because the doctor wants to test his kidney and liver. He had no health problems. He had bloodwork a month before the vaccines and everything was fine and they want to use him as a lab rat right now. Description of Product Complaint included patient was discussing the treatment for his diesel-like taste and smell that he was experiencing for a while. The doctor gave him a pantoprazole 40 mg for acid reflux. The adverse events resulted in physician office visit but not the emergency room visit. Patient received pantoprazole at a dose of 40 mg for acid reflux. The outcome of the events was not resolved. Additional information about batch/lot has been requested.

Other Meds: AMITRIPTYLINE; FIORICET; CYCLOBENZAPRINE

Current Illness:

ID: 1439809
Sex: F
Age:
State: CA

Vax Date: 03/17/2021
Onset Date:
Rec V Date: 07/01/2021
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: hair has been falling out by the hand full; It is quite frustrating; This is a spontaneous report from a contactable consumer (patient, self-reported). A 69-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on 17Mar2021 (age at vaccination: 69 year), as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that she received the Pfizer vaccine with the 2nd shot completed on 17Mar2021. Not long after receiving the vaccine, her hair has been falling out by the hand full on an unspecified date in 2021. She has found that she was not alone in this as several neighbor's family members and read elsewhere other folks who received the Pfizer vaccine have the same issue: hair falling out and asked did the Pfizer vaccine have any chemo drugs. Now she didn't know how to stop the hair loss. It was quite frustrating. She was a 69-year-old female and do not take any type of chemotherapy now or ever. The patient asked about to advise on why this was happening right after the second vaccine that she received and there were a people in our community that were interested in an answer on this subject. Outcome of the events was unknown. Information on batch/ lot number has been requested.

Other Meds:

Current Illness:

ID: 1439810
Sex: F
Age:
State: NY

Vax Date: 04/30/2021
Onset Date: 04/30/2021
Rec V Date: 07/01/2021
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: Patient had significant impairment of daily activities. She had dizziness random episodes while driving, sitting, which were not positional; mild SN hearing loss; tinnitus; Dizziness; Fatigue; arm hurt; she was feeling weird; This is a spontaneous report from a contactable physician (patient). This physician reported in response to HCP letter sent via email follow that included: This 39-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: EW0167) via intramuscular route in right deltoid on 30Apr2021 at 16:45 on a Friday (at the age of 39-year-old) as dose 1, single for COVID-19 immunisation. Medical history and concomitant medication were not reported. No pertinent family history was reported. She had no other vaccinations that day or in the four weeks prior. She did not start new medications. The patient experienced dizziness on 30Apr2021, deafness, tinnitus in May2021, fatigue, pain in extremity, she was feeling weird, loss of personal independence in daily activities on an unspecified date. Reporter called as patient who said that she was calling about the Pfizer COVID-19 vaccine because she took the first dose the 30Apr2021 and felt dizzy within 10-15-minute period, so she stood there a few minutes or whatever and then came home, and then she was still having dizziness. She said that the dizziness was not when she was moving, it was when was sitting doing work, she felts dizzy and felts fatigued. She said she was going for testing, but the reason she was calling was her second dose was scheduled for Friday and she did not think she would be able to take it then, so she would like to know how did this work. She said that they would be doing blood work and a brain MRI or something, she had an appointment with a neurologist, and she did not want to take it with the testing, without the results. Reporter said that it was given at a State government site, she set up her appointment through a website. She asked if she needs to call them to tell them she was not coming for a second dose and wants to ask if she would be able to get her second dose after the time when she knows if she was normal to get it. Reporter said her dizziness began before 5:00PM, she was feeling weird and dizzy so they put ice packs on her head for a few minutes and it was no good, she thought this was not good, it was also hot there so maybe there was something to do with it, and they said wait 15 minutes so she sat there, then slowly came home. She says she thought maybe it would go away. She says this was the main thing, her arm was also hurting, but this is normal she guesses everyone had that. She says her arm hurt for two days and then was fine after that. She says her dizziness or fatigue she did not take anything for, she did not know what to do, she thought maybe water would help. Patient had dizziness immediately after vaccine and had been persisting every day. Tinnitus started 2 weeks later with mild sensorineural hearing loss on audiology testing. No prior medical issues. Labs, MRI without contrast were normal VNG testing from ENT pending. MRI with contrast internal auditory canal pending. Patient had significant impairment of daily activities. She had dizziness random episodes while driving, sitting, which were not positional. Lab data was normal, MRI was normal. VNG test from ENT and MRI IAC with contrast was pending. Adverse event was resulted in physician office visit. Ice packs treatment received for event feeling abnormal and dizziness. Reporter said she looked it up online and it said you could get the second dose of the vaccine up to 28 days or 9 weeks or something like that, she just wanted to know if she could get it at a later date if everything was normal, like her labs or everything. Seriousness criteria was reported as persistent /significant disability/incapacity for dizziness, tinnitus and mild SN hearing loss. Reporter consider the Pfizer product had a causal effect to the adverse event. The outcome of event deafness, tinnitus, dizziness was not resolved and for rest of events was unknown. No follow-up attempts are possible. No further information is expected. Follow-up (15Jun2021): This is a spontaneous follow-up report from a contactable physician (patient). This physician reported in response to HCP letter sent via email follow that includes: Lab data was updated. No follow-up attempts are possible. 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 events Sensorineural hearing loss,dizziness,tinnitus and Activities of daily living impaired cannot be totally 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: 1439811
Sex: F
Age:
State:

Vax Date: 04/09/2021
Onset Date: 04/13/2021
Rec V Date: 07/01/2021
Hospital: Y

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: Loss of consciousness with hospitalization for six days; This is a spontaneous report from a contactable Other HCP (Nurse) and a contactable consumer (patient). An 85-year-old patient received second dose of BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiry date: Not reported), via an unspecified route of administration on 09Apr2021 as dose 2, single for COVID-19 immunisation. The patient medical history included high blood pressure, for which she takes "critical blood pressure medications- that are compounded by a special pharmacy", lot of allergies including cannot tolerate artificial sugars as they cause headaches, sensitive to many things for which she responds with flu and can only tolerate brand medications as generic" have too many fillers" for which she also developed a headache and "feels awful". She had been independent and living alone (her husband has dementia and lives in a care centre), She was able to drive and able to walk independent of assistive deceives. A history of a loss of consciousness in the past was denied. Concomitant medications included Doxazosin Mesilate (CARDURA) for high blood pressure, Vitamin D3 as dietary supplement, Alprazolam (XANAX), Metoprolol tartrate (LOPRESSOR), Cipcal Vitamin D3 Gummies and Nature's Bounty D3 Gummies, Strawberry, Orange & Lemon Flavored Gummies (Lot number:5164590, Expiry Date: 31Jan2022). The patient previously received first dose of BNT162B2 (Lot number and Expiry date: Not reported), via an unspecified route of administration, administered on 19Mar2021 as dose 1, single for COVID-19 immunisation. On 13Apr2021 the patient experienced loss of consciousness with hospitalization for six days and inpatient rehabilitation for ten days. In Apr2021, the patient had a head scan, urinalysis, throat test, unspecified blood tests and heart tests (all heart tests they could do). Outcome of the event was unknown. No Follow-up attempts are needed, information about lot/batch number can not be obtained.; Sender's Comments: Considering a plausible temporal relationship, a causal association between the reported event of loss of consciousness and suspect drug bnt162b2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Other Meds: VITAMIN D3; CARDURA; XANAX; LOPRESSOR

Current Illness:

ID: 1439812
Sex: F
Age:
State:

Vax Date: 05/15/2021
Onset Date:
Rec V Date: 07/01/2021
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: pt. is having inflammation and pain in left ankle; pt. is having inflammation and pain in left ankle; feels that bones are very weak; This is a spontaneous report from a Caremark Xeljanz C&P Program (Program ID: CEP 141003). A contactable CVS/Caremark Specialty Pharmacy reported for female patient. This is a spontaneous report from a contactable other Healthcare professional. A 36-years-old female patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on 15May2021 (at the age of 36 years old) as a dose 2, single, for covid-19 immunization; tofacitinib citrate (XELJANZ XR), oral from 2019 (Batch/Lot number was not reported) and ongoing, at 11 mg, daily for rheumatoid arthritis (From 2019 to 8May2021). Patient's medical history included, rheumatoid arthritis from 2019 and ongoing. The patient's concomitant medications were not reported. Patient took first dose of bnt162b2 on 28Apr2021 dose 1, single, for covid-19 immunization. Patient reported that, her xeljanz was on therapy hold as per md instruction to discontinue 1 week before each of the covid-19/corona virus vaccine doses, so patient stopped it a week before her Pfizer corona vaccine on 28Apr2021 and then a week before 15May2021, due to missed doses patient was having inflammation and pain in left ankle (she stepped wrong and hurt her left ankle as previously reported), felt that bones are very weak, md was aware and ordered patient to resume xeljianz on monday, 24May2021. On an unspecified date, the patient experienced pt. is having inflammation and pain in left ankle and feels that bones are very weak. Outcome of the events were unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness: Rheumatoid arthritis

ID: 1439813
Sex: F
Age:
State: OR

Vax Date: 05/18/2021
Onset Date: 05/18/2021
Rec V Date: 07/01/2021
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: reaction: allergic to product/the covid-19 had a serious side effects; The initial case was missing the following minimum criteria: adverse event. Upon receipt of follow-up information on 15Jun2021, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable consumer (patient). This consumer reported events for different vaccine doses. This is the second of two reports. This 82-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EWOI75), via an unspecified route of administration on 18May2021 (at the age of 82-year-old) as single dose for COVID-19 immunization. The patient's medical history included contusion from brain damage from 1987 and ongoing (she was hit by a drunk 30 years ago) and allergic to sulfa (Sulfonamide allergy). Concomitant medication included alprazolam (manufacturer unknown) taken for brain injury and contusion from 1987 and ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), intramuscularly on 27Apr2021 13:45 (at the age of 82-year-old) as single dose for COVID-19 immunization and experienced adverse reactions of can barely think on 27Apr2021 13:45, she is a mess and can barely walk. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 18May2021, the patient experienced reaction: allergic to product which was serious due to medically significant. The patient stated, "I did not choose to be vaccinated it was my family, my son would not see me until I had vaccinated. If I had acknowledged my allergy to sulfa they would have refused the vaccination. Because I am allergic to sulfa the covid-19 had a serious side effects." No treatment was received for the adverse event. The clinical outcome of the "reaction: allergic to product/the covid-19 had a serious side effects" was resolving. Follow-up attempts completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021515270 same patient and drug, different dose and event.

Other Meds: ALPRAZOLAM

Current Illness: Brain damage (she was hit by a drunk 30 years ago); Contusion (contusion from brain damage)

ID: 1439814
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 07/01/2021
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: a small amount of the vaccine leaked out; a small amount of the vaccine leaked out; This is a spontaneous report from a contactable other hcp (Nurse). A male patient of an unspecified age received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced a small amount of the vaccine leaked out. The reporter stated that they had a patient who while he was receiving the second dose of his Pfizer COVID 19 vaccination a small amount of the vaccine leaked out. She states that they followed the agency recommendations on if it was estimated to be less then half of the vaccine dose, not to revaccinate. This patient is concerned that he is not fully protected since some of the vaccination leaked out. Information on the batch number has been requested.

Other Meds:

Current Illness:

ID: 1439815
Sex: U
Age:
State: FL

Vax Date:
Onset Date:
Rec V Date: 07/01/2021
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: shingles; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Batch/Lot Number and expiration date were not reported) via an unspecified route of administration on unspecified date as single dose for COVID-19 immunisation. Patient's medical history and concomitant medication were not reported. On an unspecified date, patient was diagnosed with shingles after being vaccinated with the suspect vaccine. The outcome of event was unknown. Information about lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1439816
Sex: M
Age:
State: VA

Vax Date: 06/09/2021
Onset Date: 06/01/2021
Rec V Date: 07/01/2021
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: Second dose of Covid-19 vaccine administered greater than 6 hours after vaccine was mixed; Second dose of Covid-19 vaccine administered greater than 6 hours after vaccine was mixed; Second dose of Covid-19 vaccine administered greater than 6 hours after vaccine was mixed; Sore arm; This is a spontaneous report from a contactable pharmacist via Pfizer sponsored program. This report has similar events for 3 patients. This is 2 of 3 reports A 13-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE). 2nd dose. Formulation: solution for injection, Lot number EW0217) via an unspecified route of administration, on 09Jun2021, single dose (at the age of 13-years-old) for COVID-19 immunization. The patients medical history and concomitant medications were not reported. On 09Jun2021, the patient experienced product temperature excursion issue, poor quality vaccine administered, product preparation error and in Jun2021 the patient experienced pain in arm. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The clinical outcome of the events was unknown. Information on Lot/Batch number has been requested. Follow up (14Jun2021): This is a follow up spontaneous report from a contactable pharmacist. This pharmacist reported for a 13-year-old male patient that: Duplicate AE E-transmitted for report of inadvertent dosing of the vaccine past 6 hour storage in syringe. Caller would like written document sent to email address. Caller states she has not received previous email request. Response: Disclaimer Provided Pfizer has conducted physical and chemical stability studies which have shown that the vaccine maintains all its measured quality attributes when diluted vaccine is stored in polycarbonate or polypropylene syringes for 6 hours at 2 degree C to 30 degree C. Microbiological risk must be considered. Degradation of RNA in the vaccine has been observed when stored for longer than 6 hours in syringes.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021683146 same reporter, AE and product, different patient;US-PFIZER INC-2021684836 same reporter, AE and product, different patient

Other Meds:

Current Illness:

ID: 1439817
Sex: M
Age:
State: FL

Vax Date: 06/07/2021
Onset Date: 06/08/2021
Rec V Date: 07/01/2021
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: The patient was less than 12 years old; he had a lymphoma inflammation; he started complaining that his armpit hurts more than where he took his shot,; he started to feel too much pain on his arm; he also had headache; This is a spontaneous report received from a contactable consumer (parent). A 9 years old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 07Jun2021 13:30 (Batch/Lot Number: twc/71), vaccinated at the age of 9 years old, as single dose for covid-19 immunisation. Patient received the first dose on 17May2021 16:00 in Arm Left. Medical history included attention deficit hyperactivity disorder. The patient's concomitant medications were not reported. Relevant past drug history included "Mold, ash three". Patient took his second dose on Monday at 1:30PM on his left arm, at 5 pm he went to his regular ninja class (the doctor said he could exercises normally) He did one exercise then he started to feel too much pain on his arm then he stopped. Next day, on 08Jun2021 he started complaining that his armpit hurts more than where he took his shot, he also had headache. Reporter took him to the doctor and he told me he had a lymphoma inflammation. Reporter not sure if it was from the exercise or for the vaccine, Reporter just want to report to help on the research. He is under antibiotics now and still with a lot of pain when you touch it. The doctor said if not get better in 1 week he is going to take an ultrasound. Outcome of reported events was recovering.

Other Meds:

Current Illness:

ID: 1439818
Sex: F
Age:
State: IL

Vax Date: 06/09/2021
Onset Date: 06/09/2021
Rec V Date: 07/01/2021
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: Hives all over from neck down in my feet, and they are red, swollen and itchy; This is a spontaneous report from a contactable consumer (patient). A 28-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular, administered in Deltoid Left on 09Jun2021 (Lot Number: ER8730) (at age of 28-year-old) as single dose for covid-19 immunisation. Medical history was reported as No. The patient's concomitant medications were not reported. On 09Jun2021, the patient had hives all over from neck down in her feet, and they are red, swollen and itchy. The patient took Benadryl last night (09Jun2021) as treatment. when ask dose of Benadryl: Consumer stated, "I don't know I threw the package away, so I am not sure about that." The outcome of the event was not resolved.

Other Meds:

Current Illness:

ID: 1439819
Sex: F
Age:
State: IN

Vax Date: 05/27/2021
Onset Date: 05/01/2021
Rec V Date: 07/01/2021
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: She has had diarrhea for 14 days and it is worsening.; This is a spontaneous report from a contactable consumer (patient). A 64-years-old female patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot/batch no: EW0176, expiration date 01Aug2021) via unspecified route in the right arm, on 27May2021 (at the age of 64-years-old) as 1st dose, single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient stated that after the first dose of the Pfizer COVID shot on May2021, she has had 14 days of diarrhea real bad. Patient received her first dose of the Pfizer Covid-19 Vaccine and has a question about the side effect Diarrhea. She has had diarrhea for 14 days and it is worsening. She is asking how long the diarrhea will last. She stated that she talked to her Pharmacist and he recommended a medicine for her to take and she is still having diarrhea. She was wondering if there was anything she could take to help with the diarrhea because that was embarrassing and her rectum was raw and when it hits, she does not know if she had time to make it to bathroom. Pharmacist recommended her to take for the diarrhea Loperamide Hydrochloride Lot number 977532, Expiry Oct2022. Patient had no other vaccines on the same day as the suspect product. There was no emergency room or physician office visit required for the event. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Description of complaint included patient who experienced an adverse event to the suspect product COVID shot and while completing a safety report on that suspect product, caller mentioned that her Pharmacist recommended that she takes Loperamide Hydrochloride for diarrhea, and she states that her diarrhea is not getting better. query mentioned Start date for 1st dose was given as 27Apr2021 and 27May2021. Kindly, confirm the start date of 1st dose. Response After reviewing the call recording it was confirmed the first dose was given on 27May2021. This was populated incorrectly by the call handler in the designated field. The clinical outcome for the event was not recovered. No new information received. No follow-up attempts are needed. No further information is expected

Other Meds:

Current Illness:

ID: 1439820
Sex: F
Age:
State:

Vax Date: 05/22/2021
Onset Date: 05/22/2021
Rec V Date: 07/01/2021
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: Numbness in one of her legs/ I have numbness in one my leg; This is a spontaneous report from a contactable consumer (patient) through Medical Information. A 46-year-old female patient received bnt162b2 first dose of (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 22May2021 as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient stated she received her 1st dose of the Pfizer COVID 19 vaccine "3 weeks ago." She is scheduled to have her 2nd dose administered today, however states that she is unsure if the symptoms she is experiencing could be a side effect from the 1st dose. She states that the symptoms of numbness in one of her legs began shortly after the time she got her 1st vaccine. She is not sure if the two are related to one another or not but wanted to follow up and ask and see if numbness in the legs a potential side effect is and should she follow through with 2nd dose of COVID vaccination or be seen by HCP. She stated I got the first dose of the vaccine on 22May2021, this was Saturday. So, it's going to be 3 weeks in 2 days. So anyways I have this side effect and I am stepped in to see if this is a side effect of a vaccine because it started around the same time. The outcome of the event was reported as unknown. Follow up attempts are needed; information about lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1439821
Sex: F
Age:
State: NJ

Vax Date: 05/08/2021
Onset Date: 05/01/2021
Rec V Date: 07/01/2021
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: Fever; burning around the chest/has felt a burning feeling; This morning she felt the pain and it comes and goes. It stays ok for a while and feels discomfort; pain in left arm, continuing to chest and around breast; Tingling sensation around the chest; pain in left arm, continuing to chest and around breast; This is a spontaneous report from a contactable consumer or other non-health care professional from a Pfizer Sponsored Program. A 34-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0182), via an unspecified route of administration, administered in arm left on 08May2021 at 14:00 as 2nd dose, single for COVID-19 immunization. The patient did not had any medical history. Patient's husband and mother-in-law both took it and did not have that kind of feeling. They took the vaccine in both arms and she took it in the same arm, the left arm. Concomitant medications were not reported. The patient did not receive prior vaccination within four weeks.The patient historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/lot number: EW0161) via unspecified route of administration administered in arm left on 17Apr2021 as 1st dose, single for COVID-19 immunization.On 08May2021, after the second dose the patient had a fever. In may2021, for the last 15 days from date of reporting, patient has been experiencing, pain in left arm, continuing to chest and around breast and had started to get a little tingling feeling, especially when moving or running in the morning and was feeling that pain. She had booked and appointment and met with the doctor, who examined her. She did not find anything concerning. She suggested an X-ray after a week or so and did mention that it could be side effect of the vaccine. The pain just started the end of May, 2 weeks ago from today she was still experiencing the pain, mainly on the left side and has stayed the same and once or twice, has felt a burning feeling. This morning she felt the pain and it comes and goes. It stays ok for a while and feels discomfort. She stated that tingling and burning around the chest, started once when she was walking really fast. Sometimes, she feels it in the morning when she wakes up, she feels tingling and burning feeling around the chest. Everything has stayed the same. Has been the same kind of experience, the same kind of feeling. Is now having a little discomfort on left side. She stated that she had a fever which was 99 point something, for a day, then went away. It was right after she got the vaccine, the second dose, 8MAY2021. It was that night she got the fever. The treatment was received for the event fever with Ibuprofen while for other events the treatment was not received as she stated that she was just tried to sleep. The adverse events pain in left arm resulted in physician office visit. The patient underwent lab tests included blood work with unknown results on 10Jun2021 and body temperature: 99 point something on 08May2021. The outcome for the events pain in left arm, tingling sensation around the chest and burning around the chest/has felt a burning feeling was not resolved while for event pyrexia resolved on 09May2021 and outcome for other events was unknown. Information on lot/batch number was available. Additional information has been requested.

Other Meds:

Current Illness:

ID: 1439822
Sex: F
Age:
State: OH

Vax Date: 02/18/2021
Onset Date: 03/01/2021
Rec V Date: 07/01/2021
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: Twisted her knee a little bit/folding chair came down and slammed down onto her knee; Deep bruise; could only remember the itchy thing; problem with her knee on left side; Weakness to right arm; Arm just reacted strangely, ache, hurt like a toothache just where the vaccine had been placed; Arm just reacted strangely, ache, hurt like a toothache just where the vaccine had been placed; This is a spontaneous report from a contactable consumer (patient). A 86-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EL9266; Expiration Date: 31May2021), via an unspecified route of administration, administered in arm right on 18Feb2021 as 2nd dose, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EL9265, Expiry: 20May2021), dose injection to right arm, not too high up on the shoulder. The patient experienced calling to report pain, weakness to right arm, twisted her knee a little bit/folding chair came down and slammed down onto her knee, deep bruise, she hasn't gotten the vaccine for shingles, could only remember the itchy thing, problem with her knee on left side on an unspecified date, second dose hurt when it went in on 18Feb2021, arm had also sort of lost the strength in it too on an unspecified date in Mar2021, arm just reacted strangely, ache, hurt like a toothache just where the vaccine had been placed on an unspecified date in Mar2021. Patient reported that there is a dot where the second dose needle went in her arm. She do not have COVID so assumed she should get it so they could keep living. After the first dose she do not even feel anything, had no reaction to that. The second dose hurt when it went in, but she thought it would go away. So for about 3 weeks she was fine after that. Starting on unknown date in Mar2021, about 3 weeks after she was administered the second dose her arm just reacted strangely, ache, hurt like a toothache just where the vaccine had been placed. It continued that way. Her arm had also sort of lost the strength in it too which still was not returned totally. Events are ongoing, still every once in a while would come back like a toothache; people say it would go away. She asked the expected duration of events; and if potential third dose is or is not recommended relative to events. Patient thought she was about 5 feet and keeps getting shorter, used to be more than 5 feet tall. But she vacuums, moves things around, trying to do what she should do; but events are continuing and she just wondered how long it would continue yet before it went away. Doctor said they would get a third dose of the Pfizer Covid-19 Vaccine, and she do not know whether she should relative to these events. The reason she got the Pfizer Covid-19 Vaccine doses in the right arm is because 2 years ago when she got the flu shot patient had a reaction where site was very red; so she thought she was not going to get injection in the left arm again because she is left handed. She knows that not supposed to get other vaccines, so she has not gotten the vaccine for shingles. The harder she tries to remember the worse it is, then she remembered vaccine for shingles. The physician put cortisone in her shoulder because he said it was something else, that he really do not think it was from the shot. She thought well she has had no accident, no fall, no bang, nothing to produce this other than the shot. He looked at it and gave her some exercises to do, so she was going to continue with therapy at the clinic; she goes to see the lady next week. Before all this happened it was going on and on and on. She had a problem with her knee on left side which the doctor looked at during that appointment. After the Pfizer Covid-19 Vaccine was administered, about 6 weeks ago she was working out in the yard. She do not think it had anything to do with the vaccine. The patient underwent lab tests and procedures which included x-ray: unknown results on unspecified date. Therapeutic measures were taken as a result of calling to report pain, weakness to right arm, second dose hurt when it went in, arm had also sort of lost the strength in it too, twisted her knee a little bit/folding chair came down and slammed down onto her knee, deep bruise, arm just reacted strangely, ache, hurt like a toothache just where the vaccine had been placed, arm just reacted strangely, she hasn't gotten the vaccine for shingles, could only remember the itchy thing, problem with her knee on left side. The seriousness of the events was medically significant. The clinical outcome of arm had also sort of lost the strength in it too, deep bruise were recovering, of the arm just reacted strangely, ache, hurt like a toothache just where the vaccine had been placed were not recovered, of the calling to report pain, weakness to right arm, hurt when it, second dose hurt when it went in, twisted her knee a little bit/folding chair came down and slammed down onto her knee went in, she hasn't gotten the vaccine for shingles, could only remember the itchy thing and problem with her knee were unknown.

Other Meds:

Current Illness:

ID: 1439823
Sex: F
Age:
State: OH

Vax Date: 05/22/2021
Onset Date: 05/01/2021
Rec V Date: 07/01/2021
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: "rash on her stomach and bumps on the body but now went away" but she is still "itchy"/and chest with a few bumps; "rash on her stomach and bumps on the body but now went away" but she is still "itchy".; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 77-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration on 22May2021 (Batch/Lot Number: EW0172) as dose 1, single (age at vaccination 77-year-old) for covid-19 immunisation. Medical history included glaucoma from an unknown date. Concomitant medication(s) included dorzolamide hydrochloride, timolol maleate (COSOPT) and brimonidine tartrate (BRIMONIDINE AFT) taken for glaucoma from an unspecified start date and ongoing; latanoprost, netarsudil mesilate (ROCKLATAN) taken for glaucoma, start and stop date were not reported. The patient did not receive any other vaccines within four weeks prior to the vaaccination. On May2021, the patient experienced rash on her stomach and bumps on the body but now went away but she is still itchy and chest with a few bumps. "She is still a little itchy. she has been scratching on her back and arms". Caller had her first dose of the Pfizer BioNTech Covid-19 last 19May2021 and a couple days after, she had a light reaction. She developed rash on her stomach and bumps on the body but now went away but she is still itchy. Caller asked if she should hold up a day or 2 for the next vaccine because she is scheduled tomorrow for her second dose and she doesn't want to have a severe reaction to the next one because she is still itchy all over. The rash and bumps began a few days later. The rash and bumps did not happen right away, it was a delayed reaction. It was not a bad rash; it was just a slight rash. Most of the rash was on the side of her stomach and chest with a few bumps. She also had a couple of bumps on her leg and thigh. The bumps on her leg and body did not all come at once. A couple of bumps would appear, and then a couple more, and then a little bit more. She took some Benadryl, and her granddaughter brought her some cream. She had been scratching on her back and arms: She had been scratching her back and arms, but there were no bumps or anything. She had been quite itching. Some days she was really itchy. This had been going on since she received the first dose of the covid vaccine. It was not a really bad itch, but she finds herself itching, and it was not normal for her. She thinks she received the first dose of the covid vaccine on 19May2021, but she might have that date wrong. She has trouble seeing and had to get a magnifying glass to read the information off of her vaccine record card. She clarifies that she did not receive the first dose of the covid vaccine on 19May 2021. She received the first dose of the covid vaccine three weeks ago from tomorrow. She received the first dose of the covid vaccine on 22May2021. She had to get something to enlarge the writing so she could read the correct date off of her vaccine record card. Therapeutic measures were taken as a result of events includes Benadryl and some cream. The treatment not received for events She is still a little itchy. She has been scratching on her back and arms and rash on her stomach and bumps on the body but now went away but she is still itchy. The outcome for event rash on her stomach and bumps on the body but now went away but she is still itchy/and chest with a few bumps was recovered on an unknown date in May2021 and another event was not recovered. Follow-up attempts are completed. No further information is expected.

Other Meds: COSOPT; BRIMONIDINE AFT; ROCKLATAN

Current Illness:

ID: 1439824
Sex: M
Age:
State: CT

Vax Date: 04/14/2021
Onset Date:
Rec V Date: 07/01/2021
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: Nausea; Fever; Fatigue; Chest pain; Difficulty breathing; This is a spontaneous report from a contactable consumer (patient). A 49-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, #lot: Er2613) via an unspecified route of administration administered in Arm Right on 24Mar2021 and second dose (#lot: Er8629) via an unspecified route of administration administered in Arm Right on 14Apr2021 as single dose (at the age of 49-years-old) for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced nausea, fever, fatigue, chest pain and difficulty breathing on an unspecified date. The patient did not report this because he didn't think it was relevant until recent media about myocarditis. He was close 3x to dialing 911 thought was having heart attack. The outcome of all the events was unknown. Information on Lot/Batch number was available. Additional information has been requested.

Other Meds:

Current Illness:

ID: 1439825
Sex: F
Age:
State: CA

Vax Date: 05/10/2021
Onset Date: 05/10/2021
Rec V Date: 07/01/2021
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: My period started 20 days early and had NOT stopped; First dose and second dose administered on 10May2021; First dose and second dose administered on 10May2021; This is a spontaneous report from a contactable consumer (patient) reported that a 43-years-old non-pregnant female patient received first and second dose of bnt162b2 (Pfizer COVID-19, Solution for injection, Lot Number: EW0179), via intramuscular route of administration on 10May2021, 17:00 (at the age of 43-years-old) on left arm as first dose, single then (Lot Number: EW0186), via intramuscular route of administration on left arm on 10May2021 at second dose, single for COVID-19 immunisation. Medical history included allergic to shellfish and penicillin. Other medical history was none. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient had not been tested for COVID-19. Concomitant medications were not reported. The most recent COVID-19 vaccine was administered in hospital. 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. The patient received first and second dose on 10May2021. On 13May2021 at 13:00, 3 days post vaccine, the patient experienced bleeding heavily. Her period started 20 days early and had not stopped. She had been seeking treatment and have no pre vaccine condition to cause this type of bleeding. Patient received treatment for the adverse event. The patient had exam blood work ultrasound. The outcome of the event my period started 20 days early and had not stopped was not recovered and other events was unknown.

Other Meds:

Current Illness:

ID: 1439826
Sex: M
Age:
State: GA

Vax Date: 06/03/2021
Onset Date: 06/03/2021
Rec V Date: 07/01/2021
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: Severe chest pain; fever; This is a spontaneous report from a contactable consumer (patient). A 15-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0179), via an unspecified route of administration in the right arm on 03Jun2021 at 10:00 (at the age of 15-year-old) as single dose for COVID-19 immunisation in public health clinic. Medical history included Tourette's syndrome from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included pimozide taken for an unspecified indication, start and stop date were not reported. The patient previously received first dose of bnt162b2 (Lot number: EW0179), via an unspecified route of administration in the right arm on 13May2021 at 12:15 (at the age of 15-year-old) as single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 03Jun2021 at 22:00, the patient experienced severe chest pain and two days of fever up to 39.8 degree Celsius. The events were reported as non-serious. The patient did not receive any treatment for the events. The patient underwent lab tests and procedures which included fever: 39.8 centigrade on 03Jun2021. Since the vaccination, the patient had not been tested for COVID-19. The outcome of severe chest pain was resolved on an unknown date in Jun2021, and fever was resolved on 05Jun2021.

Other Meds: PIMOZIDE

Current Illness:

ID: 1439827
Sex: F
Age:
State: CA

Vax Date: 06/11/2021
Onset Date: 06/11/2021
Rec V Date: 07/01/2021
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: Numbness in tongue; Back of throat/sinus irritation; Back of throat/sinus irritation; Mild tingling of lips; This is a spontaneous report from a non-contactable consumer (patient). A 57-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EW0196), dose 2 via an unspecified route of administration, administered in left arm on 11Jun2021 18:15 (at the age of 57-year-old), as single dose for COVID-19 immunisation in pharmacy or drug Store. The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EW0185), administered in left arm on 14May2021 13:00, as single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. On 11Jun2021 at 19:15, the patient experienced mild tingling of lips, numbness in tongue and back of throat/sinus irritation. The patient visit to doctor or other healthcare professional office/clinic. Therapeutic measures were taken as a result of mild tingling of lips, numbness in tongue, back of throat/sinus irritation, back of throat/sinus irritation and treatment with Benedryl. Outcome of the events was resolving. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1439828
Sex: F
Age:
State:

Vax Date: 06/12/2021
Onset Date: 06/12/2021
Rec V Date: 07/01/2021
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: heat under my skin and like on my neck, and in my, on my face and I noticed it worse on my left side even with death feeling; I felt a feeling of anxiety right away/felt a rush in my chest of like what an anxiety attack feels like; I started getting like kind of gross taste in my mouth; I really getting this rush of really this gross metallic taste it's like a taste of like pennies and blood in my mouth; Hot burning feeling under her skin.; felt headache on right side of her head; pausing feeling in my head; rush in her head, blood; This is a spontaneous report from a consumer (patient) from a Pfizer-sponsored program. A female patient of unspecified age received BNT162b2 (COVID-19 Vaccine - Manufacturer Unknown, solution for injection, Lot Number: Unknown), via an unspecified route of administration on 12Jun2021 as dose 2, single for covid-19 immunisation. The patient medical history included anaphylactic reaction, migraine. The patient concomitant medications were not reported. The patient previously received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: Unknown), via an unspecified route on 22May2021 as dose 1, single for covid-19 immunisation experienced tired, migraines. On 12Jun2021, the patient experienced and stated that heat under my skin and like on my neck, and in my, on my face and I noticed it worse on my left side even with death feeling, felt a feeling of anxiety right away, felt a rush in my chest of like what an anxiety attack feels like, started getting like kind of gross taste in my mouth; I really getting this rush of really this gross metallic taste it's like a taste of like pennies and blood in my mouth, Hot burning feeling under her skin, rush in her head, blood, felt headache on right side of her head. Patient stated that "After the first one honestly I got tired after it and I started getting migraines but only on the right side of my head and they having gone away and I noticed that it was after that vaccine and after the initial one the first one, and then I just got the second one like honestly probably 2 hours ago and I noticing like a facts in my body right now like I didn't have prior to taking the second shot 2 hours ago, I am having this felling now like, I still have the headache on one side of my head but now I am felling this felling of like heat under my skin and like on my neck, and in my, on my face and I noticed it worse on my left side even with death feeling and I am feeling like how do I explain this like a orbit kind of like a pausing feeling in my head , I am not dead, I am not like passing out, I am just a feel like a pausing feeling and when I first got the shot right when I first got it I felt a feeling of anxiety right away. I am not scared of needles or anything, I am not gaining anxiety from getting the shot I am scared of it. I am on other medication and I have other health issues, so I wanna make sure like was this normal, is this not a good reaction because I don't wanna sit at home and think ok this was normal and within like 2 hours I have like anaphylactic reaction or something because I had an anaphylactic reaction before in my life and people make things they happen instantly, times they happen over time, it start happening slowly sometime." The outcome of the events was unknown. Follow-up attempts are needed. Further information is expected.

Other Meds:

Current Illness:

ID: 1439829
Sex: F
Age:
State: MO

Vax Date: 06/06/2021
Onset Date: 06/06/2021
Rec V Date: 07/01/2021
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: feeling like going to pass out; difficulty breathing; chest pain; Moderate headache; fatigue; moderate muscle aches; joint pain; This is a spontaneous report from a contactable consumer. A 15-years-old non-pregnant female patient received second dose of bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot number: EW0177 and Expiration date: unknown), via an unknown route of administration, in left arm on 06Jun2021 at 11:15 (at the age of 15-years-old) as dose 2 single for covid-19 immunisation. Medical history included ADHD (attention deficit hyperactivity disorder), mood disorder, asthma, NKA other than seasonal outdoor allergies and minor lactose intolerance from an unknown date. Concomitant medications included methylphenidate hydrochloride (CONCERTA); oxcarbazepine (TRILEPTAL) and salbutamol sulfate (PROAIR HFA) taken for an unspecified indication, start and stop date were not reported. Patient previously took first dose of bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot number: EW0185 and Expiration date: unknown), via an unknown route of administration, in left arm on 16May2021 at 11:00 (at the age of 15-years-old) for covid-19 immunisation. Patient did not receive any other vaccine within 4 weeks prior to covid vaccine. Prior to vaccination, the patient was not diagnosed with covid-19. On 06Jun2021 at 12:00, the patient experienced moderate headache, fatigue, moderate muscle aches, joint pain, chest pain, difficulty breathing and feeling like going to pass out. Lasted for exactly 48 hours. The case was assesses as non-serious. Patient received Ibuprofen and steroid inhaler as treatment for events. On an unspecified date in Jun2021, the events were recovered. Follow-up attempts are needed. Further information is expected.

Other Meds: CONCERTA; TRILEPTAL; PROAIR HFA

Current Illness:

ID: 1439830
Sex: M
Age:
State: WA

Vax Date:
Onset Date:
Rec V Date: 07/01/2021
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: wheezing; shortness of breath; flushing; sweating; nauseated; After 3rd infusion, (3rd loading dose) patient experienced shortness of breath, wheezing, flushing, sweating, nauseated; This is a spontaneous report from contactable nurse via Pfizer Sales Representative. A male patient of age 44 received BNT162B2 (COVID-19 Vaccine - Manufacturer Unknown, Formulation: Solution for injection), via an unspecified route of administration on an unspecified date as a dose 3, single for COVID-19 immunisation. Co-suspect medication included infliximab (INFLECTRA, Formulation: Powder for injection, Lot number: EJ1527), via an unspecified route of administration on an unspecified date as an unknown for an unspecified indication. The patient's medical history included Ankylosis Spond. Historical vaccine included BNT162B2 (COVID-19 Vaccine - Manufacturer Unknown, Formulation: Solution for injection), via an unspecified route of administration on an unspecified date in May2021 as a dose 2, single for COVID-19 immunisation, had received 2nd Covid Vaccination at least two weeks prior and the patient received BNT162B2 (COVID-19 Vaccine - Manufacturer Unknown, Formulation: Solution for injection), via an unspecified route of administration on an unspecified date as a dose 1, single for COVID-19 immunisation, 1st shot of vaccine. The patient's concomitant medications were not reported. It was reported that, after 3rd infusion (3rd loading dose), on an unspecified date, the patient experienced shortness of breath, wheezing, flushing, sweating and nauseated. Used Humira prior switching to Inflectra. (Name) stated that, it was unknown whether it was Pfizer or Moderna, but Pfizer was more commonly available being it came out first. No previous issues with Inflectra until Covid shot. The patient was not using Methotrexate. Being treated for Ankylosis Spond. No premeds were used prior to infusion. The reporter stated that, the events took place after use of product. The outcome of the events was unknown.

Other Meds: Inflectra

Current Illness:

ID: 1439831
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 07/01/2021
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: Shingles; Rash; This is a spontaneous report from a Pfizer Colleague. A non-contactable consumer (Patient) reported that a unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: Unknown), dose 1 via an unspecified route of administration on an unspecified date as single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient stated that, after the first dose, the patient developed shingles. Not certain if it was related but my doctor reported it to withheld. After a couple of days, the patient developed a rash (different than shingles) all over my body. At first doctor thought it was poison ivy, but it was quite severe. The patient was treated with vytrex for the event shingles and for the event rash, patient was on steroids (unspecified) for 12 days. It's been more than 5 weeks now; patient still had the rash (it's calming down since this past weekend but still had new rash). Patient did not know if there's any connection to the vaccine, was there other similar incidents.Neither steroids or antihistamine seemed to help much. The outcome of the event shingles was resolved on an unknown date. The outcome of the event rash was not resolved. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1439832
Sex: U
Age:
State:

Vax Date: 06/01/2021
Onset Date: 06/01/2021
Rec V Date: 07/01/2021
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: I have been feeling a real sick; Headache; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date in Jun2021 as dose 1, single for covid-19 immunisation. The patient medical history was none. The patient concomitant medications were not reported. On an unknown date in Jun2021, the patient has been feeling a real sick and had headache. Reportedly, patient was on day 5 after first shot (Unspecified Shot) here for the Covid thing and had been feeling a real sick. Patient was little better today, just had a headache and was just wondering if that was normal as patient was on day 5. The outcome of the events was unknown. Follow-up attempts are needed. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1439833
Sex: F
Age:
State: FL

Vax Date: 06/11/2021
Onset Date: 06/11/2021
Rec V Date: 07/01/2021
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: I had fallen asleep in chair; wiped my nostril and saw blood. It bled profusely for almost 5 minutes/nasal bleeding; wiped my nostril and saw blood. It bled profusely for almost 5 minutes/nasal bleeding; This is a spontaneous report from a contactable consumer (patient). A 65-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0179), via intramuscular route of administration in the left arm on 11Jun2021 at 08:30 (at the age of 65-year-old) as dose 1, single for COVID-19 immunization in pharmacy or drug store. Medical history included ongoing Hashimoto, more than 5 years ago, asthma from an unknown date in Mar2020 and ongoing, ongoing hypertension, more than 10 years ago. The family history included Hashimoto, asthma and hypertensive. Concomitant medications included lisinopril; magnesium, vitamin d nos; all for hypertension from an unspecified start date and ongoing. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient reported that she had fallen asleep in chair. It was in the afternoon; she woke up and her nose felt like it was running. She wiped her nostril and saw blood. It bled profusely for almost 5 minutes. She never had a nosebleed in her life (On 11Jun2021 at 17:15, the patient had nasal bleeding then again on 13Jun2021 at 17:15). The patient did not receive any treatment for the events. The outcome of the events was reported as resolved. Additional information is requested.

Other Meds: LISINOPRIL; MAGNESIUM; VITAMIN D NOS

Current Illness: Asthma; Hashimoto's disease (Onset Date: > 5years ago); Hypertension (Onset Date: > 10years ago)

ID: 1439834
Sex: M
Age:
State: SC

Vax Date: 06/12/2021
Onset Date:
Rec V Date: 07/01/2021
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: Headache; This is a Spontaneous report from a contactable Consumer. This consumer reported for 15-year-old male patient (reporter's son). A 15-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot Number: EW0178), dose 2 via an unspecified route of administration, administered in arm left on 12Jun2021 as dose 2, single for COVID-19 immunization, (age at the time of vaccination was 15-year-old). The patient medical history and concomitant medications was not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot Number: Unknown), dose 1 via an unspecified route of administration, administered on 22May2021 as dose 1, single for COVID-19 immunization, (age at the time of vaccination was 15-year-old). On an unspecified date the reporter stated, I have the question, my son (consumer) had his second (Pfizer) vaccine (unspecified vaccine) yesterday (12 Jun 2021) and he has headache (overnight). I just wanted to know whether I could give him something worth medicine (treatment) for the headache." The patient did not receive any treatment for the above event. Outcome of the event was reported as unknown. Information on Lot/Batch number was available. Additional information has been requested.

Other Meds:

Current Illness:

ID: 1439835
Sex: F
Age:
State: IL

Vax Date: 03/10/2021
Onset Date: 03/10/2021
Rec V Date: 07/01/2021
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: Beginning about 8 hours after the 2nd shot I started having body aches, and headache. As the night wore on I started having fever and chills with a SEVERE headache like nothing I have ever had before.; Beginning about 8 hours after the 2nd shot I started having body aches, and headache. As the night wore on I started having fever and chills with a SEVERE headache like nothing I have ever had before.; Beginning about 8 hours after the 2nd shot I started having body aches, and headache. As the night wore on I started having fever and chills with a SEVERE headache like nothing I have ever had before.; Beginning about 8 hours after the 2nd shot I started having body aches, and headache. As the night wore on I started having fever and chills with a SEVERE headache like nothing I have ever had before.; extreme fatigue; This is a spontaneous report from a contactable consumer (patient herself). A 49-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EN6201) via an unspecified route of administration in left arm on 10Mar2021 08:15 as dose 2, single (at the age of 49-years-old) for COVID-19 immunization. The patient was not pregnant at the time of vaccination. Patient medical history included hypothyroidism. The concomitant medications included levothyroxine sodium (SYNTHROID), multivitamins [vitamins NOS] and OXYBUTYNIN. Historical vaccine included BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EN6201) via an unspecified route of administration in left arm on 17Feb2021 13:15 for COVID-19 immunization. Patient did not have COVID-19 prior to vaccination. Patient was not tested for COVID-19 post vaccination. Patient did not receive any vaccine in four weeks. On 10Mar2021 at 15:00 Beginning about 8 hours after the 2nd shot patient started having body aches, and headache. As the night wore on she started having fever and chills with a severe headache like nothing she had ever had before. The following day was much of the same, fever, body aches, severe headache and extreme fatigue. 48 hours post injection all of the symptoms were gone with the exception of a headache which lingered about another 12 hours. She was still having almost daily headaches 3 months later and not sure if it was vaccine related or coincidence but not normal for her. The patient did not receive any treatment for the adverse events. On an unspecified date in Mar2021, the outcome of the events was resolved with sequel. Information about lot/ batch number has been requested.

Other Meds: SYNTHROID; OXYBUTYNIN; MULTIVITAMINS [VITAMINS NOS]

Current Illness:

ID: 1439836
Sex: F
Age:
State: WA

Vax Date: 06/04/2021
Onset Date: 06/12/2021
Rec V Date: 07/01/2021
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: large rash around injection site. skin hot to the touch, swollen, itchy, painful; large rash around injection site. skin hot to the touch, swollen, itchy, painful; large rash around injection site. skin hot to the touch, swollen, itchy, painful; large rash around injection site. skin hot to the touch, swollen, itchy, painful; large rash around injection site. skin hot to the touch, swollen, itchy, painful; This is a spontaneous report from a contactable consumer (patient). A 61-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot Number: EW0185) via an unspecified route of administration, in right arm on 04Jun2021 at 16:30 (at the age of 61-years-old) as 1st dose, single for covid-19 immunisation. The patient medical history was reported as known allergies to zinc. Concomitant medications in two weeks included multi vitamin, paracetamol (TYLENOL) and ibuprofen (ADVIL). The patient did not receive any vaccines within four weeks prior to the vaccination. On 12Jun2021 at 11:00, the patient experienced large rash around injection site. Skin hot to the touch, swollen, itchy and painful. Prior to vaccination patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. Any treatment received for the event was unknown. Outcome of all events was not recovered.

Other Meds: TYLENOL; ADVIL [IBUPROFEN]

Current Illness:

ID: 1439837
Sex: F
Age:
State: WA

Vax Date:
Onset Date:
Rec V Date: 07/01/2021
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: tremors and headache; tremors and headache; This is a spontaneous report from a contactable Nurse via Pfizer sales representative. A 72-years-old female patient 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 an unspecified date as 2nd dose, single dose for covid-19 immunisation. The patient medical history was not reported. Concomitant medications included methotrexate sodium taken for an unspecified indication, start and stop date were not reported; adalimumab (HUMIRA) taken for an unspecified indication, start and stop date were not reported; infliximab (REMICADE) taken for an unspecified indication, start and stop date were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown, Expiration date: Unknown), on an unspecified date as 1st dose, single dose for covid-19 immunisation. On an unspecified date, the patient experienced tremors and headache. After 15th infusion, patient experienced tremors and headache, post 2nd Vaccination for Covid believed to be Pfizers. Patient used Humira, prior to switching to Remicade. Had received 2nd Covid Vaccination at least two weeks prior to their infusion. (Name) said it was unknown if it was Pfizer or Moderna, but Pfizer was more commonly available being it came out first. No previous issues with Remicade until 2nd Covid shot. Event took place after use of product. The outcome of the events was unknown. Information on lot/ batch number has been requested.

Other Meds: METHOTREXATE SODIUM; HUMIRA; REMICADE

Current Illness:

ID: 1439838
Sex: M
Age:
State: CA

Vax Date: 06/13/2021
Onset Date: 06/14/2021
Rec V Date: 07/01/2021
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: Stabbing pain in abdomen, as if someone was stabbing my abdomen and moving it up and down; This is a spontaneous report from a contactable consumer. A 19-year-old adult male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EW0178), via unspecified route of administration in the left arm, on 13Jun2021, as dose 2, single for COVID-19 Immunisation. Medical history was not reported. Concomitant medications included Spironolactone and Estradiol. The patient had no known allergies. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EW0173), via unspecified route of administration in the left arm, on 23May2021, as 1st dose, single for COVID-19 Immunisation. On 14Jun2021 at 13:00, the patient experienced stabbing pain in abdomen, (Reported as: as if someone was stabbing his abdomen and moving it up and down). 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 and Since the vaccination, the patient had not been tested for COVID-19. The outcome of the event was unknown.

Other Meds: SPIRONOLACTONE; ESTRADIOL

Current Illness:

ID: 1439839
Sex: F
Age:
State: IL

Vax Date: 03/25/2021
Onset Date: 03/25/2021
Rec V Date: 07/01/2021
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: Diagnosed with Shingles; Accidental overdose; This is a spontaneous report from a contactable consumer (patient). A 51-year-old non-pregnant non pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER2613), via an unspecified route of administration, administered in arm right on 25Mar2021 (at the age of 51-years-old) as dose 1, single and second dose (Batch/Lot Number: EW0158) via an unspecified route of administration, administered in Arm Right on 25Mar2021 as dose 2 single for covid-19 immunisation at the hospital. The patient had no medical history. The patient had no known allergies. The patient's concomitant medication included sertraline hydrochloride (ZOLOFT) taken for an unspecified indication and unspecified allergy medications and vitamins. The patient had no other vaccine in four weeks. No covid prior vaccination. The patient was not tested for covid post vaccination. On 25Mar2021, the patient experienced accidental overdose. On 10Jun2021, the patient was diagnosed with shingles. As a treatment for diagnosed with shingles the patient received valtrex, topical. The clinical outcome of the diagnosed with shingles was recovering and the outcome of the accidental overdose was unknown.

Other Meds: ZOLOFT

Current Illness:

ID: 1439840
Sex: M
Age:
State: FL

Vax Date: 01/08/2021
Onset Date: 02/09/2021
Rec V Date: 07/01/2021
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: A ringing in both my years, this has continued continuously 24 hours a day; It seems to inhibit my hearing acuity. To this day my hearing seems to be diminishing at noticeable daily rate; An impairment in my vision. it manifested in both eyes equally as a washed out field of vision making it hard to read and discern fine details. also see some small sparkles in my eyes; A red spotted rash UNDERNEATH skin. The rash covered all torso up to neck, arms,wrist and legs to ankles. The rash subsided within about two weeks however to this day I still show some traces; A red spotted rash UNDERNEATH skin. The rash covered all torso up to neck, arms,wrist and legs to ankles. The rash subsided within about two weeks however to this day I still show some traces; A low grade fever daily of appr 99.5 starting every day at 3:00 PM until after midnight. The fevers continued daily; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 67-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EL1283), via an unspecified route of administration, administered in left arm on 08Jan2021 12:00 (age at vaccination was 67 years) as single dose, patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EL9262) via an unspecified route of administration, administered in left arm on 08Jan2021 (age at vaccination was 67 years) as single dose for COVID-19 immunization. The patient medical history included allergic to penicillin. The patient concomitant medication included famotidine (PEPCID AC) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not test COVID-19 positive prior to vaccination. The patient had tested for COVID-19 since the vaccination on an unspecified date in 2021. On or about 09Feb2021 the patient experienced a running a low-grade fever daily of approximately 99.5 starting every day at 3:00 PM lasting until after midnight. The fevers continued daily until approximately 26Feb2021. On 19Feb2021 patient saw a red spotted rash underneath his skin. The rash covered all his torso up to his neck, arms to his wrist, and legs to ankles. The rash mostly subsided within about two weeks however to this day he still shows some mild traces of this rash on his torso. On 04Mar2021 patient had noticed a ringing in both his ears, this has continued continuously 24 hours a day, to this date. It seemed to inhibit his hearing acuity. To this day patient hearing seems to be diminishing at noticeable daily rate. On 07Mar2021 patient had noticed an impairment in his vision. This impairment was manifested in both eyes equally as a washed-out field of vision making it hard to read and discern fine details. At times he also saw some small sparkles in his eyes. The patient said that he was experiencing strong side effects of the Covid-19 vaccine. The patient underwent lab tests and procedures which included pyrexia: 99.5 on 09Feb2021, sars-cov-2 test: negative on 16May2021 Nasal Swab. The outcome of the events was not recovered. Information on the lot/batch number has been requested.

Other Meds: PEPCID AC

Current Illness:

ID: 1439841
Sex: F
Age:
State: OR

Vax Date: 05/29/2021
Onset Date: 06/02/2021
Rec V Date: 07/01/2021
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 period started two days early on 02Jun (which by itself is not an issue) but I have not stopped bleeding since then and am still passing actual tissue/clots almost daily.; I have not stopped bleeding/ am still passing actual tissue/clots almost daily; This a spontaneous report from consumer (Patient). A 47-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EW0187), via an unspecified route of administration on 29May2021 (at the age of 47)(at 11:30 AM), as dose 2, single in left arm for covid-19 immunization at vaccine clinic. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient medical history was not reported and ha d no allergies to medications, food, or other products. Device Date was reported as 15Jun2021. The patient's concomitant medications included lexapro (escitalopram oxalate) and collagen powder(collagen hydrolysate). The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EW0173) via unspecified route on left arm on 01May2021 01:30 PM for COVID-19 Immunization. On 02Jun2021 (at 12:00PM), patient experienced her period started two days early on 02Jun (which by itself is not an issue) but she has not stopped bleeding since then and still passing actual tissue/clots almost daily. The outcome of the events was not recovered.

Other Meds: LEXAPRO; COLLAGEN HYDROLYSATE

Current Illness:

ID: 1439842
Sex: F
Age:
State: TX

Vax Date: 04/07/2021
Onset Date: 04/01/2021
Rec V Date: 07/01/2021
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: had the first dose of the Pfizer COVID-19 vaccine on 07Apr2021 and on Saturday of that week, she tested positive for COVID-19; really high fever; she was sick with Covid; tired; back ache; This is a spontaneous report from a Pfizer COVAX support. A 44-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for Injection, Lot Number: EW0156), via an unspecified route of administration, administered on Arm Right at the age of 44-year-old on 07Apr2021 11:30 as single dose for covid-19 immunization. Medical history (including any illness at time of vaccination) and Family Medical History Relevant to adverse event was reported as none. There was no adverse event following prior vaccinations. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. Reporter stated that she got the vaccine on Wednesday and by Friday or Saturday, she was sick with Covid and stated it was kind of the perfect storm, being exposed at the same time as she got the first vaccine. Reporter stated she doesn't have prescribed Healthcare Professional and confirms it was the Pfizer Covid Vaccine she received. Reporter stated her first dose was given on Wednesday, 07Apr2021 and by Saturday she had COVID. On 09Apr2021(Friday), she started feeling kind of tired, rundown and she stated that she was thinking it might be the vaccine side effect at first, she wasn't super concerned but by Saturday morning, she had a very high fever and tested positive on Saturday morning. She confirmed that she had the rapid test positive on 10Apr2021. Reporter stated that the tiredness and fever, took her a solid, close to 7 days to recover and the tiredness took her between 7 and 9 days to feel better. She stated that she would say some of the tiredness and backache actually started earlier in the week as she had a busy week, she was done a lot of stuff, staying up late at night. She stated that she was tired, her back hurt a little bit, because she was being physically active, but looking back she was probably having mild symptoms perhaps prior to that Friday and stated at the time she was worked too hard, done too much, staying up too late, all those things probably were very mild symptoms even on the Wednesday when she got the shot and by Friday she felt like okay, she was tired. She wanted to know if she can get the second dose of the Pfizer COVID-19 vaccine and to know if there is a timeframe in getting the second dose. The patient underwent lab tests and procedures which included sars-cov-1 test positive: positive on 10Apr2021. The patient did not visit to Emergency Room/ Physician Office. The outcome of the events tired was recovered on 18Apr2021, really high fever was recovered on 17Apr2021, back ache was recovered on an unspecified date in 2021 whereas she was sick with covid was unknown. Follow-up 15Jun2021: New information from a contactable consumer includes patient medical history, vaccine administered information, events onset date, Physician room visit, outcome of events, adverse event details.

Other Meds:

Current Illness:

ID: 1439843
Sex: F
Age:
State: VA

Vax Date: 04/09/2021
Onset Date: 04/19/2021
Rec V Date: 07/01/2021
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: leukocytoclastic vasculitis (LCV)/petechial/purpuric lesions on lower legs and feet/crops of lesions/rash; This is a spontaneous report from a contactable health care professional. An 18-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 1 intramuscular administered in Arm Left on 09Apr2021 (Lot Number: ER2613) as dose 1, single for covid-19 immunisation in Pharmacy or Drug Store. The patient medical history was not reported. No known drug allergies. Concomitant medication received within 2 weeks of vaccination included cetirizine hydrochloride (ZYRTEC). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient began with petechial/purpuric lesions on lower legs and feet on 19Apr2021. Patient has had continued crops of lesions appear since that time. Has worsened over time. Was diagnosed with leukocytoclastic vasculitis (LCV). A biopsy was collected on 12May2021. The patient was put on an oral prednisone taper, showed improvement on high doses but once tapered down, rash returned worse with no resolution. Visited 3 times and 2 visits to her pediatrician has not resolved. Continued worsening over time. Events resulted in Doctor or other healthcare professional office/clinic visit. No covid prior vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. Covid test type post vaccination: Nasal Swab, SARS-CoV-2, NAA on 11May2021 with Negative result. The outcome of event was not recovered. Event was reported as non-serious and not results in death, life threatening, caused/prolonged hospitalization, disabling/incapacitating, congenital anomaly/birth defect.; Sender's Comments: Based on temporal association, the causal relationship between bnt162b2 and the event leukocytoclastic vasculitis cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes 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: ZYRTEC [CETIRIZINE HYDROCHLORIDE]

Current Illness:

ID: 1439844
Sex: F
Age:
State: WI

Vax Date: 05/07/2021
Onset Date: 06/01/2021
Rec V Date: 07/01/2021
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: she had a scratchy throat; On Saturday morning, she had a scratchy throat, and she has been coughing more; headache; eyes were itching and burning; eyes were itching and burning; she was so cold; bone-racking chills/ shivering; really high fever of 103.4F; pretty dehydrated; This is a spontaneous report received from a contactable consumer (patient). This 63-year-old female received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: EW0169; Expiry date UNKNOWN), via intramuscular route of administration, in Arm left, on 07May2021 at 13:30 (at the age of 63-year-old), as a single dose, for Covid-19 immunization. The patient medical history included arthritis. The patient's concomitant medications included Tylenol for arthritis. Patient was previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: EW0169; Expiry date UNKNOWN), via intramuscular route of administration, in Arm left, on 16Apr2021 13:30 (at the age of 63-year-old), as a single dose, for Covid-19 immunization; and Shingrix (She received the first dose of Shingrix about a month before in Feb2021 and 2nd She received the second dose of Shingrix on 18Mar2021). The patient did not receive additional vaccines on same date of the Pfizer Suspect. On 05Jun2021, the patient had really high fever reached up to 103.4 degrees Fahrenheit and she had bone-racking chills and was shivering which lasted whole Saturday night through Tuesday, 08Jun 2021. She could not take a shower because she was so cold. She had to crank up the air conditioning in her room up to 73 degrees, and she thought that was really odd. At home, she normally Kept her air on 68 degrees. She was hot natured. She went to bed that night and woke up late the next morning with a headache on 06Jun2021, and her eyes were itching and burning. She thought it was because of seasonal allergies, and all of the pollen in the air. On the same day (on sunday afternoon), she was so cold. She was sitting in her chair with a heating pad on her back, and two blankets on top of her. Her temperature at that point was 97.7 degrees Fahrenheit. She felt so hot that she kicked everything off, and she still felt hot. She rechecked her temperature, and it was 102.2 degrees Fahrenheit. She took a Tylenol for arthritis and she took that anyways, but she took an extra dose in the middle of the day for her fever. The fever lasted for a while. She checked her temperature a couple of hours later, and her temperature was 103.4 degrees Fahrenheit and clarified that this was on 06Jun2021. It was a pretty quick spike, by that same evening, her temperature was 99.9 degrees Fahrenheit. But that was still feverish for her, normal for her was 96.8-97.2 degrees Fahrenheit. 97.7 degrees Fahrenheit was on the higher range for her. She was freezing all night and woke up in the middle of the night with shivering chills. This was not normal for her. On 06Jun2021, she had headache which lasted all day Tuesday till 08Jun2021. On Monday, 07 Jun 2021, she was in bed bundled up. Her temperature the rest of the time was 98.7 degrees Fahrenheit or 98.9 degrees Fahrenheit. Seriousness criteria: Unknown, she states that is why she called today. She woke up on Wednesday, 09Jun2021, and still had a headache. But once she got to moving around, the headache went away. She thinks she got a headache because she was pretty dehydrated on an unspecified date in Jun2021, and the fever dried her out. The reporter (patient) stated that her husband had Ankylosing Spondylitis, and took an immunosuppressant, so he was a very vulnerable person hence her husband wanted her to get the vaccine, so she went with it. Her and her husband got it at the same time. On an unspecified date in Jun2021, she went to get tested for covid this week. On 12Jun2021 (Saturday morning), she had a scratchy throat, had cough and she had been coughing more. This was infrequent with other symptoms, and she was attributing them to allergies. She thought, she was getting her annual case of bronchitis. The patient stared that her weight was 188.2 pounds and had recently lost 88 pounds and she was happy to say she was under 200 pounds and stated that she had more weight to lose. There was no emergency room and physician Office visits for the events. The patient received treatment for the fever only with Tylenol. The patient underwent lab tests and procedures which included Really high fever showing body temperature at 103.4 Fahrenheit, on 05Jun2021, 97.7 degrees Fahrenheit on 06Jun2021, 102.2 and rest of the time was in between 98.7 to 98.9 on an unspecified date in Jun2021; Covid test got negative for both rapid test and PCR test, on an unspecified date in Jun2021; and weight showed under 200 pounds as recently lost 88 pounds on an unspecified date in Jun2021. The outcome of the events fever of 103.4f (pyrexia) and chills was resolved on 08Jun2021, the outcome for headache was resolved on 09Jun2021, the outcome for cough resolved on an unspecified date in 2021, for throat irritation was resolving while the outcome for eyes were itching and burning, pretty dehydrated, and feeling cold was unknown.; Sender's Comments: The causal association between the event Pyrexia and Cough and the suspect drug BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) 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: TYLENOL

Current Illness:

ID: 1439845
Sex: F
Age:
State: GA

Vax Date:
Onset Date:
Rec V Date: 07/01/2021
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: inflammation & pain have been going on for five months now; inflammation & pain have been going on for five months now; I am not able to walk or grasp items with my hands. I cannot care for myself.; I am not able to walk or grasp items with my hands. I cannot care for myself.; I cannot care for myself.; This is a spontaneous report from a Pfizer sponsored program Pfizer via a contactable consumer (patient, self-reported). A female patient of an unspecified age received a dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on an unspecified date, as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that she needed someone to contact her regarding treatment/reversal to her immune systems over reaction to the mRNA from the Covid Vaccine. On an unspecified date, the patient had inflammation and pain have been going on for five months now. She has been to the ER twice now. Her PCP has not been able to help. She was referred to a rheumatologist who has not been able to help her since she did not have RA. She could not take any more steroids because they were damaging her body. She was not able to walk or grasp items with her hands. She could not care for herself. There was no Product quality complaint (PQC) present. Outcome of the event inflammation and pain have been going on for five months now was not recovered and for all other events, it was unknown.

Other Meds:

Current Illness:

ID: 1439846
Sex: M
Age:
State: CA

Vax Date: 04/24/2021
Onset Date:
Rec V Date: 07/01/2021
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: pain in his arm and shoulder; pain in his arm and shoulder; he got the second shot for COVID and he could not move his arm; big bulge under his arm; pain is from the hand, up to the shoulder, neck and head; pain is from the hand, up to the shoulder, neck and head; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 24Apr2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 immunisation and had no reaction. On 24Apr2021, the patient got the second shot for Covid and he can't move his arm. This was the first time of him feeling bad and then when he got home and began to walk around, he had to sit. For 11 days he had pain on pain on pain and little by little he started to get under his arm, a big bulge. He put ice on it and it went down and he took something for inflammation, but still the pain stayed. Now the past few weeks he had seen his doctor and asked about it and went to Orthopedic doctor about the right shoulder and he told them about the pain in his left arm from the shot and they sent him to do a MRI. He said it's not right because the MRI is expensive and the insurance had to pay. The pain was killing him and no one was doing nothing for him. He did not know what to do once the results come back at the end of this week. Again, mentioned he had MRI of shoulder and left arm. The pain is from the hand, up to the shoulder, neck and head. He stated he was still experiencing pain in his arm and shoulder. Wanted to know what will happen to him because he already went to the doctor and they did not know. Should he see the doctor again. Went to the place he got the vaccine and the nurse had to call him back and was surprised what happened to him. He was having a poor time and now had to stay home. Just wanting to know how long he was going to stay like that. The 24th of this month will be 2 months. How long do side effects last. He had undergone MRI and was currently awaiting results. He asked "How long does it stay like that? This kind of pain. He could have a heart attack. Scared because of his son". Indicated son passed from Sars-COV-2. Outcome of the event pain in his arm and shoulder was not recovered and other events was unknown. Information about lot/batch number has been requested.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 636,615

Page last modified: 03 October 2021 5:28pm