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**
PLEASE CHECK BACK SOON
Download the files above while you wait.






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: 1000181
Sex: F
Age:
State: FL

Vax Date: 01/18/2021
Onset Date: 01/18/2021
Rec V Date: 02/04/2021
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: Bad headache; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received BNT162B2 first dose on 18Jan2021 15:30 on left arm at single dose for COVID-19 immunization at Parking lot of a big stadium. Medical history included stressed and headache, both from 18Jan2021 before vaccine and medication to help sleep. Concomitant medication included ongoing clonazepam (KLONOPIN) tablet at 2mg pill at night to help sleep. Vaccine not Administered at Military Facility. No History of all previous immunizations with the Pfizer Vaccine considered as suspect. No Additional Vaccines Administered on Same Date. No Prior Vaccinations within 4 weeks. She is calling because she got the vaccine today and she has a bad headache. She mentioned she knows headache is a possible side effect. However, she is calling to see what she can take or what she cannot take for the headache. She stated before getting the vaccine she was stressed and had a headache that had started today, 18Jan2021, before she got the vaccine. She mentioned she was waiting 3.5 to 4 hours before getting the shot and that is when the headache started. However, after getting the vaccine it has gotten worse and it is to the point where she wants to place an icepack on her face. Stated it could be situational. She knows she was in the car for at least 5 hours. She also mentioned the paperwork we provide with a list of symptoms should also have listed what medications she can or cannot take. She finds it troubling that we do not have the listed on the paperwork. We have headache could be a possible symptom, but no information on what can be taken for symptoms. She also mentioned she needed her reading glasses to attempt to read the patient card provided that list the lot number and details regarding date for next dose. She then stated after looking at the card it is impossible to read. She cannot read the person's handwriting. The lot number is so messy. She believes it is: L2 7 or 8, 922 or 422, something like that, she cannot really tell the handwriting is so messy. The event not require a visit to Emergency Room or Physician's Office. The outcome of the event was not recovered. Information on the lot/batch number has been requested.

Other Meds: KLONOPIN

Current Illness:

ID: 1000182
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 02/04/2021
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: fever that lasted for a day then it resolved; This is a spontaneous report from a Pfizer sponsored program IBCC (Inbound Call Center for HCPs). A non-contactable consumer reported for a male patient (her husband). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced fever that lasted for a day then it resolved on an unspecified date with outcome of recovered on an unspecified date. Caller wanted to know any data available for covid vaccine use in GBS (Guillain-Barre syndrome) and autoimmune disorder. caller sated her husband had reaction to the vaccine, fever that lasted for a day then it resolved. caller stated she has autoimmune disease also so wanted to know does the vaccine worsen the symptoms. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1000183
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 02/04/2021
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: dull headache; body aches; This is a spontaneous report from a contactable consumer, the patient received from Pfizer. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 vaccination. Medical history and concomitant medication were not reported. On an unspecified date, the patient experienced dull headache and body aches. The clinical outcome of dull headache and body aches was unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1000184
Sex: M
Age:
State: AZ

Vax Date: 01/17/2021
Onset Date: 01/19/2021
Rec V Date: 02/04/2021
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: dizziness; This is a spontaneous report from a contactable consumer (patient's wife). This consumer reported same events for two patients. This is the second of two reports. A male patient (husband) of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EL1284 and expiry date unknown) via unspecified route of administration on 17Jan2021 at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient's wife reported that she got the shot on Sunday (17Jan2021) along with her husband (patient). The patient's wife informed that all of the sudden she was getting dizzy, otherwise they had no problem. She even made a second appointment. The reporter informed that her husband (patient) was getting it also. The reporter informed that the dizziness for both of them started today on 19Jan2021. The outcome of the event dizziness was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021061733 same reporter/drug/event and different patients

Other Meds:

Current Illness:

ID: 1000185
Sex: M
Age:
State:

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

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

Lab Data:

Allergies:

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

Symptoms: Had a stroke; This is a spontaneous report from a contactable consumer via Pfizer-sponsored programs. A male patient (reporter's husband) of an unspecified age received first single dose of BNT162B2 (Solution for injection, batch/lot number and exp date not reported), via an unspecified route of administration on an unspecified date for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient got the first dose of Covid vaccine on an unspecified date (Friday) at 12:35 PM, and had a stroke on Saturday morning at 10:30AM and was confined at the hospital (date/s unspecified) at the time of reporting. Reporter asked if there was any correlation or any fact sheets available with the vaccine and the stroke that happened to the patient. The outcome of the event was unknown. Information about lot number and expiry date for the suspect product will be requested in follow-up attempts.

Other Meds:

Current Illness:

ID: 1000186
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 02/04/2021
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: patient bled, and a proportion of vaccine in the syringe was not administered; patient bled, and a proportion of vaccine in the syringe was not administered; This is a spontaneous report from a contactable pharmacist. A patient of unspecified age and gender received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot/batch number and expiration date not provided), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose for COVID-19 immunization. The pharmacist had a question regarding incomplete administration of 2nd dose of bnt162b2. While one patient was given a vaccine, patient bled, and a proportion of vaccine in the syringe was not administered on an unspecified date. The pharmacist asking was there any information about giving a third dose to those who received invalid second dose. The outcome of the events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based on temporal association, the causal relationship between bnt162b2 and the event haemorrhage 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:

Current Illness:

ID: 1000187
Sex: F
Age:
State: OR

Vax Date: 01/15/2021
Onset Date: 01/16/2021
Rec V Date: 02/04/2021
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: Body aches; Chills; Headache; Arm was really, really sore - the whole arm; This is a spontaneous report from a contactable consumer (patient who is a mental health therapist). A 50-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number and Expiration Date were not reported), via an unspecified route of administration in left arm, on 15Jan2021 at 16:00 (4 PM), at a single dose, for COVID-19 immunization. The patient had no medical history and concomitant medications. No other vaccines were given the same day or 4 weeks prior. No problem with vaccines in past that she can recall from childhood. The patient received the vaccine last Friday (15Jan2021) and side effects started early evening Saturday (16Jan2021) or late afternoon. The patient had body aches, a few chills, headache, and her arm was really, really sore - the whole arm. At the time of reporting, all are way better. The patient was recovering from the events. Information about lot number and expiration date for the suspect product will be requested in follow-up attempts.

Other Meds:

Current Illness:

ID: 1000188
Sex: F
Age:
State:

Vax Date: 01/15/2021
Onset Date:
Rec V Date: 02/04/2021
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: very itchy throat; can't sleep; This is a spontaneous report from a contactable consumer (patient). A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 15Jan2021 as a single dose for COVID-19 immunization. Medical history included "underlying conditions." Concomitant medications were not reported. The patient reported after she received the vaccine her throat was very itchy and no pain on an unspecified date. It bothered her so much that she couldn't even sleep. She wanted to know if this was a normal side effect to be very itchy in the throat. She had called out of work since Monday (18Jan2021) and did not want to go to the emergency room where people had COVID. She did not want to be around people. The outcomes of the events were unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.

Other Meds:

Current Illness:

ID: 1000189
Sex: M
Age:
State: OH

Vax Date: 01/18/2021
Onset Date:
Rec V Date: 02/04/2021
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: anxious; This is spontaneous report from a contactable consumer (patient's niece). A 92-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were unknown) via an unspecified route of administration, on 18Jan2021, at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient's niece reported that her uncle had the Pfizer vaccine yesterday and now was acting really anxious. She was wondering if this is normal. Outcome of the event was unknown. Information on lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1000190
Sex: F
Age:
State: OR

Vax Date: 01/14/2021
Onset Date: 01/17/2021
Rec V Date: 02/04/2021
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: left paraclavicular lymphadenopathy; This is a spontaneous report from a contactable nurse (patient) reported that a 30-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246), intramuscular on the left arm on 14Jan2021 14:30 at a single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. Patient was not pregnant. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), intramuscularly on the left arm on 23Dec2020 10:45 for Covid-19 immunization. It was reported that approximately 72 hours (17Jan2021) after second dose, the patient developed left paraclavicular lymphadenopathy. No treatment received was reported for the reported event. The outcome of the event was not recovered.

Other Meds:

Current Illness:

ID: 1000191
Sex: F
Age:
State: CA

Vax Date: 01/05/2021
Onset Date: 01/05/2021
Rec V Date: 02/04/2021
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: tested for antibodies, and does not have any; States her second dose was on 05Jan2021, that was day number 18 after the first one.; States her second dose was on 05Jan2021, that was day number 18 after the first one.; This is a spontaneous report from a Pfizer-sponsored program from a contactable pharmacist (patient). A 47-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on 05Jan2021 at single dose (reported as 0.3, unit not provided) for COVID-19 immunisation, by injection to left arm. Medical history was none. Concomitant medications included levothyroxine sodium (SYNTHROID). Historical vaccine included first dose of BNT162B2 on an unknown date for COVID-19 immunisation. The patient states her second dose was on 05Jan2021, that was day number 18 after the first one. On 18Jan2021 the patient was tested for antibodies, and does not have any. She was expecting to have antibodies. She is not sick, she did not get sick, but because she didn't have antibodies it is upsetting, but there is nothing going on with body because she doesn't have the antibodies. Calling to find out what she should do now, if she needs to be revaccinated. The event was reported serous as medically significant. Outcome was not recovered. Method of assessment: Global Introspection was related, there is no reason why she wouldn't develop antibodies normally.; Sender's Comments: The 47-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), on an unknown date, and then received second dose on 05Jan2021, that was day number 18 after the first one. On 18Jan2021 the patient was tested for antibodies, and does not have any. There is possibility of false negative COVID-19 antibody test. The exact reason was unknown. The case will be reassessed should additional information become 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: SYNTHROID

Current Illness:

ID: 1000192
Sex: F
Age:
State:

Vax Date: 09/01/2020
Onset Date:
Rec V Date: 02/04/2021
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: headache; This is a spontaneous report received from a non-contactable consumer (patient) via Medical Information Team. An 80-year-old female patient received pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) (PREVNAR 13; Solution for injection in pre-filled syringe), via an unspecified route of administration on Sep2020 at single dose for immunization. The patient medical history and concomitant medications were not reported. It was reported that, the patient received a dose of pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) on Sep2020 after her physician recommended her to be immunized with the vaccine after the risk of Pneumonia and COVID-19 concomitantly. The patient developed a headache on an unspecified date after the administration of the vaccine pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) and that persists up to this day. The patient reports that her Physician had studied her medical conditions with tests, and MRI and different medications but it has not taken away the headaches. The outcome of the event was reported as unknown. No follow-up attempts are possible. Information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1000193
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 02/04/2021
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: Diverticulitis; little bit of pain; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient) reported that a female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient got her first shot of covid vaccine, sometimes she have Diverticulitis a little bit of pain and she wanted to find out if it's ok to take antibiotics and also get the second shot on the 28th. The outcome of the events was unknown. Information on the Lot/Batch number has been requested

Other Meds:

Current Illness:

ID: 1000194
Sex: M
Age:
State: CA

Vax Date: 01/10/2021
Onset Date: 01/10/2021
Rec V Date: 02/04/2021
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: Stomach upset; This is a spontaneous report from a contactable pharmacist. A 47-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3246), intramuscular in the left arm on 10Jan2021 (at the age of 47-year-old) as a single dose for COVID-19 immunization. Medical history included hypertension. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. . The patient did not receive any other vaccines within four weeks prior to the vaccination. Historical vaccine included Dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL0140), intramuscular, left arm on 20Dec2020 for COVID-19 immunization. On 10Jan2021, the patient experienced stomach upset. The patient took Compazine for the stomach upset. The clinical outcome of the event stomach upset was recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.

Other Meds:

Current Illness:

ID: 1000195
Sex: F
Age:
State: FL

Vax Date:
Onset Date:
Rec V Date: 02/04/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: shoulder was sore and painful; This is a spontaneous report from a contactable consumer (patient's husband). A female patient of an unspecified age received the first dose of bnt162b2 (BNT162B2), Batch/lot number was not provided, via an unspecified route of administration from an unspecified date as a SINGLE DOSE for COVID-19 vaccination. Medical history was none. There were no concomitant medications. The consumer reported his wife had the same vaccine and her shoulder was sore and painful on an unspecified date. They still have pain when they move their shoulder. The consumer later clarified that her shoulder is not sore anymore. They put an ice on their shoulder. Outcome of the shoulder was sore and painful was recovered on unknown date. Information on lot number/batch number was requested.

Other Meds:

Current Illness:

ID: 1000196
Sex: F
Age:
State: NJ

Vax Date: 01/13/2021
Onset Date: 01/01/2021
Rec V Date: 02/04/2021
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: Aches and pains; Fatigue; Fever/My temperature was 99 which "generally" (not clarified) my temperature is usually 97; Arm was extremely painful; Joint pain; Headache; Could not work today because I was not feeling good; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Lot), via an unspecified route of administration, on 13Jan2021 (at the age of 63-years-old) as a single dose for COVID-19 vaccination. Medical history includes heart disorder. Concomitant medication included: Simvastatin, Atenolol, and medicine for my "heart". The patient reported that she received the first dose on 23Dec2021 and stated she had no reaction. On an unspecified date, the patient stated "I could not work today because I was not feeling good from the vaccine. I got it on the 13th I had off some work yesterday so I had a temperature aches and pains, fatigue and I had to call out last night. Today I am running still very slight fever, aches and pains - so it is improving." The first day, I was fine. I got it at the end of the day. The second day my arm was not red or anything but it was extremely painful, joint pain, headache, fatigue and my temperature was 99 (my temperature is usually 97). Today the temperature is lower and that does not hurt as much." The clinical outcome of the events malaise, aches and pain, fatigue, pyrexia, pain in arm, joint pain, and headache was unknown. No follow-up attempts are possible. No further information is expected.

Other Meds: SIMVASTATIN; ATENOLOL

Current Illness:

ID: 1000197
Sex: F
Age:
State: AZ

Vax Date: 01/05/2021
Onset Date: 01/01/2021
Rec V Date: 02/04/2021
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: Do not believe he gave it IM, I believe he gave it subQ; Redness; Swelling; heat coming out; Skin lesions 4.5 to 7cms/Red spot on my arm; Low grade temperature elevation; Fatigue; This is a spontaneous report from a contactable physician (patient). A 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EH9899, reported as "SARS-COV-2 then it says Pfizer EH9899", expiry date: Unknown), subcutaneous on 05Jan2021 at single dose for COVID-19 immunization (reported as "To not get COVID 19"). Medical history included hypothyroidism. Concomitant medication included levothyroxine sodium (SYNTHROID) 25mcg, once a day for hypothyroidism. The patient got the vaccine last Tuesday (05Jan2021). When she got the vaccine, the gentleman was from military who gave the vaccine. The patient does not believe that he gave it intramuscular (IM), she believed that he gave it "subQ" because she had no muscle tenderness and "skin a 4.5 by 7cm skin reaction", and it was nowhere near the deltoid muscle. The patient had a high degree of suspicion that he gave it "subQ" (subcutaneous). When asked for the anatomical location of administration, the patient stated that "He gave it on my right arm but it was not into the deltoid, I think he gave it subcutaneously. I am not positive of that but missed the deltoid, it was lower, it was below the deltoid, it was in between the deltoid and the bicep and I am assuming it was subQ because none of my muscles were sore at all after getting the vaccine, accept that big red spot on my arm". Patient asked "Now my question to you is because I looked through all your literature and I can't find anything about this". Since then the skin lesion within a couple of days it was up to about 4.5 to 7cms. It was still about that size however the redness has gone way down, "the not redness", just pink, the swelling was almost gone. The heat coming out of it was almost gone. The patient mentioned that the actual skin region was much better, it was still about the same size though. Patient was not too worried about that and stated "what am concerned about is what I've also have is a low grade temperature elevation and some fatigue. If I got it on 3 O'clock on Tuesday the 5th that would be day 9. Is the 9 days post injection for dose 1 to still have a low grade temperature elevation and some fatigue. Is that acceptable or does that indicate a problem?". Patient stated the she went to her internist and he had a look at it and he said "I had no idea, he said that they just don't have experience like this. Do you have a phone number that I can talk to somebody?". The patient was about 5' 7" (height) and about 175 pounds (weight) approximately. The patient stated that fatigue and temperature elevation started one or two days after the vaccine (Jan2021). Patient reported that she still have it. The fatigue was much less but it was there and low grade temperature elevation was still there. There was no investigation assessment. The patient assessed that the events swelling, redness, skin lesions, temperature and fatigue were related to COVID-19 vaccine, also reported as "Yes, because I never had that before and I am not taking anything now. So, it is like yes. It is definitely because that. The two main symptoms I am asking about are the fatigue and the low grade temperature elevation". Outcome of the events fatigue and skin lesion, redness, swelling and heat coming out was recovering, for low grade temperature elevation was not recovered.

Other Meds: SYNTHROID

Current Illness:

ID: 1000198
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 02/04/2021
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: Tested positive for COVID in between the doses for the vaccines; Tested positive for COVID in between the doses for the vaccines; This is a spontaneous report from a Pfizer sponsored program. A contactable registered nurse (not the patient) reported a patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; COVID Vaccine a Pfizer product; lot number: EK9231) via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Reporter added they were exposed before getting it and did not realize that they were exposed. The patient was tested positive for COVID in between the doses for the vaccines, on an unspecified date. She was wondering what we suggest they do with the second dose. The outcome of event was unknown.; Sender's Comments: Based on the information currently available, a lack of efficacy with BNT162B2 in this patient cannot be completely excluded.

Other Meds:

Current Illness:

ID: 1000199
Sex: M
Age:
State: NY

Vax Date: 12/30/2020
Onset Date: 01/12/2021
Rec V Date: 02/04/2021
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: positive COVID-19 test with no symptoms; positive COVID-19 test with no symptoms; This is a spontaneous report from a Pfizer-sponsored program from a contactable physician (patient). A 56-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EL1284), via an unspecified route of administration on 30Dec2020 at single dose for COVID-19 immunisation. Medical history and concomitant medications were none. The patient had a PCR test on 12Jan2021 and was COVID-19 positive, asymptomatic. The patient had a rapid test on 14Jan2021 and came out negative. The doctor was asking if he can be able to get the second vaccine a longer than 3 weeks which is in the 6th week, asking if it could make a difference since he was tested positive. The outcome of the events was recovered on 14Jan2021.; Sender's Comments: The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on 30Dec2020, and a PCR COVID-19 test positive on 12Jan2021, asymptomatic. No complete effect of the suspect vaccine could be reasonably achieved from first dose to protect from the targeted infection. Further information is needed for a full meaningful medical assessment.

Other Meds:

Current Illness:

ID: 1000200
Sex: U
Age:
State: PA

Vax Date:
Onset Date:
Rec V Date: 02/04/2021
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: Allergic reaction; This is a spontaneous report from a contactable Other HCP. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced allergic reaction on an unspecified date. Event outcome was unknown. Information on Lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1000201
Sex: F
Age:
State: MO

Vax Date: 01/15/2021
Onset Date: 01/15/2021
Rec V Date: 02/04/2021
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: I feel like I have a lump in my throat and I have a hard time when I lay down breathing it feels like just something caught in my throat and it was not there before; I feel like I have a lump in my throat and I have a hard time when I lay down breathing it feels like just something caught in my throat and it was not there before; This is a spontaneous report received from a contactable consumer (who is also the patient). A 77-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK4176, expiry date: unknown), via an unspecified route of administration, on 15Jan2021, at single dose, for COVID-19 immunization. Medical history included inflammatory bowel disease. Concomitant medication included diphenoxylate from 14Jan2021 for inflammatory bowel disease. The patient stated, "I feel like I have a lump in my throat and I have a hard time when I lay down breathing it feels like just something caught in my throat and it was not there before. I never had that before and it feels like I have a hard time when I lay down to breathe and I was wondering if that has anything to do with the side effect of this vaccine." When asked for treatment, patient stated, "No, because it just started yesterday (15Jan2021). That is why I called you. I wanted to know if that dangerous. Do I have to go to an emergency clinic because today is Saturday and everything is closed or should I just do not worry about it." The outcome of the events was unknown.

Other Meds: DIPHENOXYLATE

Current Illness:

ID: 1000202
Sex: U
Age:
State:

Vax Date: 01/14/2021
Onset Date: 01/01/2021
Rec V Date: 02/04/2021
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: woke up with little aches; Dizzy; Little breathless; Heart goes pumping; Nervous; Very tired; I don't know if I'm dehydrated; Not feeling well; This is a spontaneous report from a contactable consumer (patient). A 77-year-old patient of unspecified gender received bnt162b2 (BNT162B2, lot number and expiry date were not reported), via an unspecified route of administration, on 14Jan2021 at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient received the COVID vaccine on Thursday, 14Jan2021. The patient was doing well on the day of vaccination. The following day, 15Jan2021, the patient was very tired. At the morning of the report, 16Jan2021, the patient woke up with little aches, tired, but they don't know what it was. The night before, 15Jan2021, the patient got a little get upset from something, a door man, or some noise. But all of a sudden, they got a little breathless, and I felt little dizzy. And the patient had some orange juice, (Beverage company name withheld) and a little cereal. The patient commented, "I guess, it's the dizziness, lightheaded and you know, your heart goes pumping a little, a little dizzy and things like that. So, I just thought I'd call." The patient added, "I have Allegra here, I didn't take it though. I have a little (Beverage company name withheld). I just got a little nervous, I live alone and except the (Beverage company name withheld). I hope, I don't know if I could go or act to sleep or just a little lightheaded, you know, breathless and dizzy and I wasn't sure of that. And it's two days, Thursday afternoon and it's Friday. I don't know, this is strange, I don't know if I'm dehydrated or this reaction to the vaccine, Pfizer. I can't tell you, I am just a little scared. I am not feeling well, and I wanted to know if there is anything dangerous? Or anything I can do?" The patient's second dose was scheduled on 04Feb2021. Outcome of the events was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1000203
Sex: M
Age:
State: FL

Vax Date: 01/12/2021
Onset Date: 01/13/2021
Rec V Date: 02/04/2021
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: sugar was elevated a whole lot/went real high; This is a spontaneous report from a contactable consumer (patient). A 79-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown), via an unspecified route of administration on 12Jan2021 at single dose for Covid-19 immunization (wanted to get because of the virus). The patient's medical history included hard of hearing and diabetes (reported as "diabetes and stuff). Concomitant medications included empagliflozin (JARDIANCE), dulaglutide (TRULICITY), and other medications (as reported " I take stuff for blood pressure all kind of stuff"). The patient reported that he got the vaccine on Tuesday (12Jan2021), he stated that he has diabetes and stuff and he noticed on Wednesday, Thursday, Friday his sugar was elevated a whole lot and he thought that would be possibly from the vaccine or it might be stressed because the Covid (unspecified). He stated that he doesn't know but it's unusual, he means it went real high. He wanted to know if there are any reports of like affects it might cause on hi sugar to go high. The patient checked this morning (unspecified date) it was high and just checked about 20 minutes ago and it has come down again so (further not clarified)." The patient mentioned that he takes Jardiance and Trulicity, once a week; he took Trulicity this morning (unspecified date) and stated, "so that probably helped". He had an unspecified laboratory test about 3 months ago, and there was no problem." The outcome of event was unknown. Information on the lot/batch number has been requested.

Other Meds: JARDIANCE; TRULICITY

Current Illness:

ID: 1000204
Sex: F
Age:
State: NY

Vax Date: 01/12/2021
Onset Date: 01/12/2021
Rec V Date: 02/04/2021
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: Did get a reaction and my hands swelled up about 20 minutes after the vaccine and my tongue swelled up; Doctor said I cannot take the 2nd dose of the vaccine; Did get a reaction and my hands swelled up about 20 minutes after the vaccine and my tongue swelled up; Doctor said I cannot take the 2nd dose of the vaccine; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EH9899 and expiration date Mar2021), via an unspecified route of administration first dose on 12Jan2021 at single dose for covid-19 immunisation. The patient's medical history included Asthma, Allergy, and Penicillin allergy. Concomitant medication included fexofenadine hydrochloride (ALLEGRA) for allergy at 180 mg, daily, budesonide (PULMICORT) for Asthma at Pulmicort is a inhaler 180, 2 puffs a day, montelukast sodium (SINGULAIR) for Asthma at 10 mg. Historical vaccine includes Tetanus and experienced allergic reaction. Past drug includes Sulphur and experienced allergy. It was reported that the patient had the vaccine on 12Jan2021 and patient was working in long term care "administrator". The patient did get a reaction and the patient hands swelled up about 20 minutes after the vaccine and her tongue swelled up. The patient did take Benadryl. The patient called her primary care doctor and was told to stay on the Benadryl and the patient was okay. The patient stated that the pharmacist that gave her the vaccine gave the Benadryl right away when the patient started swelling up. The patient spoke to her allergist and stated that she cannot take the second dose vaccine. So, the patient was concerned about her coverage because she work in a long term case. The doctor would not give me the shingle vaccine (unspecified vaccine) because they were afraid the patient would have a reaction to that. The outcome of the events was unknown.

Other Meds: ALLEGRA; PULMICORT; SINGULAIR

Current Illness:

ID: 1000205
Sex: F
Age:
State: TX

Vax Date: 01/14/2021
Onset Date: 01/01/2021
Rec V Date: 02/04/2021
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: acting weird and wouldnt eat; UTI; Aspirations phenomena; This is a spontaneous report from a Pfizer Sponsored Program Pfizer First Connect. A female patient of an unspecified age started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 14Jan2021 at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The reporter was calling about mother. Said Mom is in E.R. Had received covid vaccine on Thursday. Friday she was ok. Saturday mom was acting weird and wouldn't eat. Saturday night she was thrashing around and wouldn't settle down so they took mom to E.R. was diagnosed with Aspirations phenomena and UTI. Treated the UTI then put her in nursing home. The outcome of the events was unknown. Information about lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1000206
Sex: F
Age:
State: PA

Vax Date: 12/18/2020
Onset Date: 12/18/2020
Rec V Date: 02/04/2021
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: Elevation of Blood pressures proceeded with high 155/95; heart flutter; extreme breast tenderness; axillary swelling; felt general unwell feeling; This is a spontaneous report from a contactable healthcare professional reporting for self. This 49-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number= EL0140) via intramuscular on 18Dec2020 12:00 PM at right arm at single dose for COVID-19 immunization. Medical history included known allergies: cinnamon. Patient did not have COVID prior vaccination. Concomitant medications included cyanocobalamin (B12), zinc, 4-(4-hydroxyphenyl)butan-2-one, crocus sativus, magnesium oxide (BELL DE NUIT PRECIOUS MAGICAL). It was reported that first day approx 6 hours after injection patient felt general unwell feeling, next day (19Dec2020) extreme breast tenderness and initiation of axillary swelling. At day 10 post injection (28Dec2020) she experienced some type of heart flutter. Elevation of Blood pressures proceeded with high 155/95 on unspecified date. PCP visit with normal EKG and blood work following week. BP in office 135/85 (from memory). Patient did not receive second dosage at day 21 and BP has currently returned to normal this a.m. (20Jan2021) 117/68. There was no treatment received for events. Patient did not test COVID post vaccination. The outcome of events was recovered.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. 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 RAs, Ethics Committees, and Investigators, as appropriate.

Other Meds: B12 [CYANOCOBALAMIN]; ZINC; BELL DE NUIT PRECIOUS MAGICAL

Current Illness:

ID: 1000207
Sex: F
Age:
State: MN

Vax Date: 01/11/2021
Onset Date: 01/14/2021
Rec V Date: 02/04/2021
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: cellulitis in right arm below injection site; fever; headache; chills; fatigue; This is a spontaneous report from a contactable nurse (patient). A 32-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, unknown lot number and expiration), via an unspecified route of administration in right arm on 11Jan2021 at 07:45 AM at a single dose for COVID-19 immunization in a hospital. Medical history reported as none. The patient has no known allergies. The patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; unknown lot number and expiration) on 23Dec2020 at 07:45 AM in left arm for COVID-19 immunization. Concomitant medications included dicyclomine; and unspecified birth control and multivitamin. The patient experienced fever, headache, chills, fatigue, and then got cellulitis in right arm below injection site following second dose of COVID vaccine on 14Jan2021 at 12:00 PM. The events resulted in emergency room/department or urgent care visit. The patient has no COVID prior to vaccination and was not tested for COVID post vaccination. The patient did not receive other vaccine in four weeks. The patient received antibiotics (Keflex) as treatment for the events. The patient recovered from the events in Jan2021. Information on the Lot/Batch number has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Vaccination site cellulitis cannot be excluded. The case will be reassessed if 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: DICYCLOMINE

Current Illness:

ID: 1000208
Sex: F
Age:
State:

Vax Date: 01/11/2021
Onset Date: 01/15/2021
Rec V Date: 02/04/2021
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: Have swelling of Lymph Nodes; This is a spontaneous report from a contactable consumer. A 72-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 11Jan2021 at a single dose for covid-19 immunisation. The patient's medical history included hypertension from an unknown date and unknown if ongoing. Concomitant medication included hydrochlorothiazide, losartan, and amlodipine for hypertension. The patient experienced swelling of lymph nodes on 15Jan2021. The outcome of the event was unknown. Information on the Lot/Batch Number has been requested.

Other Meds: HYDROCHLOROTHIAZIDE; LOSARTAN; AMLODIPINE

Current Illness:

ID: 1000209
Sex: F
Age:
State: NY

Vax Date: 12/29/2020
Onset Date: 12/29/2020
Rec V Date: 02/04/2021
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: was supposed to get the second dose yesterday 19Jan2021 but location is closed/ could get it up to the 26Jan2021; paralysis of the chin and half of the face; and around the mouth; This is a spontaneous report from a contactable consumer report for self. A 49-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at right arm on 29Dec2021 20:00 PM for COVID-19 immunization. Medical history included ongoing severe migraines. None family history. There were no concomitant medications. No Prior Vaccinations within 4 weeks. After an hour she had paralysis of the chin and half of the face; and around the mouth. It only lasted a few minutes, like 10 minutes and then it went away, she was fully recovered. She did not got to a doctor or the ER. Adds she was supposed to get the second dose yesterday 19Jan2021 but she has to go to another location as that location is closed. They told her she could get it up to the 26Jan2021 and then it would be more problematic to get. The event outcome was recovered on 29Dec2020. Information on the lot/batch number has been requested.

Other Meds:

Current Illness: Migraine

ID: 1000210
Sex: F
Age:
State: IN

Vax Date:
Onset Date:
Rec V Date: 02/04/2021
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: patient was positive; patient was positive; This is a spontaneous report from a contactable nurse. A 34-year-old female patient (nurse's daughter) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EK9231), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunization. Medical history was none. There were no concomitant medications. The nursed reported that "The patient was positive, the whole family had COVID and they all came down which was about the same time which was 29Dec. She was treated in the ER with steroids and since that point we have all recovered until she went for the 2nd dose. Probably close to 10 days ago, they did do some lab work at the hospital". The outcome of events was unknown.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 cannot be excluded for reported events.

Other Meds:

Current Illness:

ID: 1000211
Sex: U
Age:
State:

Vax Date: 01/14/2021
Onset Date: 01/15/2021
Rec V Date: 02/04/2021
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: Diarrhea; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route single dose for COVID-19 immunization on 14Jan2021, 3 o'clock (unspecified in am or pm). Medical history and concomitant medication were not reported. The patient went swimming next day (15Jan2021) for an hour without stopping and did water aerobics and nothing hurt. The patient was doing great but came down with a little diarrhea, Friday, Saturday, and Sunday (from 15Jan2021 to 17Jan2021). The patient woke up this morning (17Jan2021) and stated probably had it during the night. Action taken for BNT162B2 was not applicable. Outcome of the event was unknown. Information on the batch/lot number has been requested.

Other Meds:

Current Illness:

ID: 1000212
Sex: M
Age:
State: WI

Vax Date: 01/19/2021
Onset Date: 01/20/2021
Rec V Date: 02/04/2021
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: typical Bell's Palsy; right side facial pain near the anterior right ear and traveling down the facial cranial nerve from that area to his jaw; right side facial pain near the anterior right ear and traveling down the facial cranial nerve from that area to his jaw; Weak feeling coming from the jaw; This is a spontaneous report from a non-contactable nurse (wife). A 38-year-old male patient (husband) received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot Number EL3248 and Expiration Date unknown) via an unspecified route of administration on 19Jan2021 18:00 (vaccine location: left arm) at single dose for COVID-19 immunisation. The patient's medical history included hypogammaglobulinaemia, from years low IGA, chickenpox and shingles in the past. The concomitant medications were not reported. No history and additional vaccines administered on same date. On 20Jan2021 when patient woke up, right now at 09:21 AM, he noticed right side facial pain near the anterior right ear and traveling down the facial cranial nerve from that area to his jaw. Reporter stated this was typical Bell's Palsy and the usual treatment is the same as for herpes zoster; steroids and antivirals is the recommended treatment. Reporter is planning to call the doctor as she feels he needs treatment right away and she will get the doctor to prescribe this treatment. Patient has a weak feeling coming from the jaw. Patient had a history of chicken pox and chronic herpes zoster but this was the first time he had had Bell's Palsy. States the effects are persisting and medically significant. Patient was scheduled for the second dose 09Feb2021. Wanted to know about if patient should get the second dose of the vaccine. The outcome of events was not recovered. No follow-up attempts are possible. No further information is expected.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. 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 RAs, Ethics Committees, and Investigators, as appropriate.

Other Meds:

Current Illness:

ID: 1000213
Sex: F
Age:
State: AZ

Vax Date: 01/14/2021
Onset Date: 01/14/2021
Rec V Date: 02/04/2021
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: tested for COVID and result came out positive/ body ache, fever, headache and cough; tested for COVID and result came out positive/ body ache, fever, headache and cough; This is a spontaneous report from a contactable other healthcare professional (patient). A 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL0142), via an unspecified route of administration, on 24Dec2020 at single dose as first dose, on left deltoid on 14Jan2021 as second dose at single dose to protect patient from COVID. Medical history included prediabetes and blood pressure high. Concomitant medication included metformin for prediabetes, losartan for blood pressure high. The patient's second vaccine (COVID 19 Vaccine) was just past this 14Jan2021. Then she had a lot of symptoms on 14Jan2021, the patient had like body ache, fever, headache and cough. The patient started to have suddenly with the side effects from the vaccine and then it was fine until yesterday and then she had to go in and get tested for COVID because she had never tested positive and her result came out this morning positive in Jan2021. The patient received Tylenol as treatment. The outcome of events was unknown.; Sender's Comments: Based on the information currently available, lack of efficacy of the suspected vaccine BNT162B2 cannot be completely excluded. However, individuals may not be protected until at least 7 days after their second dose of the vaccine. It is unlikely that the patient would have fully developed immunity due to the very short time lag between the second vaccine dose and the event onset.

Other Meds: METFORMIN; LOSARTAN

Current Illness:

ID: 1000214
Sex: F
Age:
State: NC

Vax Date: 12/29/2020
Onset Date:
Rec V Date: 02/04/2021
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: Tested positive for the COVID-19; Tested positive for the COVID-19; Headache; This is a spontaneous report from a Pfizer sponsored program Pfizer First Connect via a contactable consumer (patient) reported for herself. A female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 29Dec2020 at single dose for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient got her first dose of this Vaccine date is 29Dec2020 and now she had tested positive for the COVID-19, so she wants to know if what to do if she should take the second dose which is scheduled 19Jan2021. Physician confirmed it was COVID-19 Vaccine of Pfizer. She had got a headache. Events outcome was unknown. Information about lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1000215
Sex: F
Age:
State: SD

Vax Date: 12/30/2020
Onset Date: 12/31/2020
Rec V Date: 02/04/2021
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: impairing her from driving/ bothering her while driving; panic; nauseous; increasingly more and more dizziness with visual disturbances; increasingly more and more dizziness with visual disturbances/She feels things are moving that aren't; This is a spontaneous report from a contactable physician, the patient. A 45-year-old female physician received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: EK9231, Expiry: Apr 2021), intramuscularly in the left deltoid on 30Dec2020 at 16:30 (at the age of 45-years-old) as a single dose for COVID-19 immunization. Medical history included heartburn. Concomitant medications included (dexlansoprazole) DEXILANT for heartburn from an unspecified date (reported as a year and a half). The patient did not receive any other vaccinations within 4 weeks prior to the vaccine. On 31Dec2020, the patient experienced dizziness with visual disturbances. She was having increasingly more and more dizziness with visual disturbances where today (20Jan2021) she felt nauseous from that. It was impairing her from driving because she felt things were moving that weren't and made her panic on the interstate, as of an unspecified date. It. Initially it was bothering her while driving, but now she noticed it while sitting at her desk or when she ate. It was all the time now. The reporter assessed the events "increasingly more and more dizziness with visual disturbances/she feels things are moving that aren't" as being between disabling and medically significant. The patient did not visit the emergency room or a physician's office, although stated it probably did require it. The patient queried whether to receive the second dose today as her symptoms were worsening. The clinical outcome of "increasingly more and more dizziness with visual disturbances/she feels things are moving that aren't" was not resolved, and of nauseous, "impairing her from driving/ bothering her while driving" and panic were unknown.; Sender's Comments: Based on a compatible temporal relationship causality between events dizziness with visual disturbances and 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: DEXILANT

Current Illness:

ID: 1000216
Sex: M
Age:
State:

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

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: Pneumonia; Eosinophil count high; allergic reaction; This is a spontaneous report from a contactable consumer (patient's wife). An 81-year-old male patient received the first dose of COVID-19 vaccine (UNSPECIFIED TRADE NAME), via an unspecified route of administration on 04Jan2021 at single dose for covid-19 vaccination. The patient's medical history and concomitant medications were not reported. The patient had his first vaccine dose on 04Jan, then 7 days later he was in the hospital with a really high eosinophils count and infiltrate in his lungs, they did a CAT scan, and he had pneumonia in there. Patient's wife said that he was in the hospital for three days for Pneumonia, and now he was out of the hospital and he was supposed to get his second dose of the vaccine on the 25th. She would like to know if her husband should have the second dose, since she didn't know if the pneumonia was caused from the vaccine for sure, it could be an allergic reaction for the vaccine since his count was 22.2 for absolute eosinophils and that was down now to 2.4. She would like to know if it was safe for him get the second dose. She said her husband was still coughing and she didn't know, she was afraid for him to get it. The patient underwent lab tests and procedures which included a CAT scan in Jan2021 and he had pneumonia in there , absolute eosinophils: 22.2 (Eosinophil count high) in Jan2021, absolute eosinophils: 2.4 in Jan2021. The outcome of the events was unknown. Information about lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1000217
Sex: F
Age:
State: NC

Vax Date: 01/07/2021
Onset Date: 01/01/2021
Rec V Date: 02/04/2021
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: Cough, Limb discomfort, Pain, SARS-CoV-2 test positive

Symptoms: Disoriented; Urinary tract infection; Shingles/rash; Complaining of pain and burning; Complaining of pain and burning; she was not feeling that well; lose her mental faculties; This is a spontaneous report from a contactable pharmacist. A 94-year-old female patient (reporter's mother) receive the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246), via an unspecified route of administration on 07Jan2021 (around 3:15 PM to 3:20 PM) at 0.3 mL, single (0.3ml dose injection in right arm) for COVID-19 immunization. Medical history included blood pressure, cholesterol, blood thinner and fluid. The patient historical vaccine included varicella zoster vaccine live (ZOSTAVAX) for immunization. There was no history of all previous immunization with the Pfizer vaccine considered as suspect as this was the first dose. The patient had no prior Vaccinations within 4 weeks. Concomitant medications included ongoing apixaban (ELIQUIS) for blood thinner, ongoing furosemide (LASIX) for fluid, valsartan for blood pressure, ongoing pravastatin for cholesterol. The reporter was calling because her mother had the COVID-19 Vaccine on 07Jan2021, it was on a Thursday. By that Friday (08Jan2021) she was not feeling that well. Caller stated she did not know if what occurred had any correlation to the vaccine, but she wanted to report these details in case this started to be came a problem. Her mother is 94 years old and was in very good shape. However, now she was in the hospital completely disoriented. Since getting the vaccine she had subsequently broke out with shingles two days after getting the vaccine on 09Jan2021. Caller reiterated she was not saying this had anything to do with the vaccine, but she just wanted to reported these events. Caller initially stated it was unknown why patient was admitted to the hospital. She went on to explain her mother, the patient, was complaining of pain and burning. She started complaining of this pain and burning in the evening like around 5PM (on 08Jan2021 17:00). She later broke out into shingles. Caller mentioned patient has not had the SHINGRIX vaccine yet. However, she did have the older vaccine, ZOSTAVAX. Caller confirmed patient received the ZOSTAVAX years before. Patient went to the Emergency Room the first time on 09Jan2021 due to complaining of pain and burning and they could not find anything wrong with her. They checked her vitals and ran several tests and it all came back fine. They then sent her home. Patient went back to the Emergency Room on 10Jan2021 and completed another battery of test, labs, checked vitals, had chest x-ray, and cat scan at this time they could not diagnose with Shingles. On 11Jan2021, the patient had an appointment with her Primary Doctor and he did not find anything wrong. Patient came home with caller's sister and she was helping her get undressed. That was when the sister noticed a rash on the patient's body. The rash broke out on her body on Monday 11Jan2021. They tried to call the doctor that night, but did not get a response. On Tuesday 12Jan2021 they took the patient to urgent care and that was when she was formally diagnosed with Shingles. She was started on medication for the Shingles, Acyclovir, and sent home. They also thought she had a slight Urinary Tract Infection. She was started on CIPRO for the urinary tract infection. Patient was home for a couple of days in Jan2021 and she was not getting any better. She was then starting to lose her mental faculties. They thought this was from the urinary tract infection. Caller clarified the patient was then admitted to the hospital on 16Jan2021 due being disoriented. For causality assessment, it was mentioned that it is so coincidental this happened right after getting the vaccine. She was healthy and then it was like a snowball. The outcome of the events was unknown.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events 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: ELIQUIS; LASIX [FUROSEMIDE]; VALSARTAN; PRAVASTATIN

Current Illness:

ID: 1000218
Sex: F
Age:
State: LA

Vax Date: 01/08/2021
Onset Date: 01/14/2021
Rec V Date: 02/04/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Asthenia, Chills, Headache, Myalgia

Symptoms: rash that looks like measles; rash on right side that goes around to back looks like diaper rash; This is a spontaneous report from a contactable pharmacist. An 87-year-old female patient started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number EK9231), via an unspecified route of administration on 08Jan2021 at single dose for covid-19 immunisation. Medical history was none. There were no concomitant medications. The patient stated she had this injection 08Jan2021, states the following Thursday, 14Jan2021, she broke out with 2 different reactions, a rash that looks like measles all over, the second reaction is part on her back looks like a little kid has not had their diaper changed, like diaper rash, like half a belt from the right side to the back. States she is very concerned, the patient went to a dermatologist who she had a lot of faith in, doctor met her at the door, read about it but has never seen a reaction like this. States that they injected her with something and it worked in two different places. States she did a biopsy on her hip and took movies to show her students, called her and stated she need to report this event. The patient states she wants to know if she should get the second vaccine. States she used to be 5 foot 2 inches, shrunk prior to vaccine. The patient last night to report but she could not get through. Stated she got injection on right arm. The patient stated the rashes are trying to improve. States the rash that looks like measles started on the right side and now is all over. The patient stated she is allergic to bromines and swims in a bromine salt water heated swimming pool and this has nothing to do with it but the point she is saying is that she says your allergic to things and then not have reactions and sometimes you do. Both events were serious with criteria of medially signicant. The patient underwent lab tests and procedures which included biopsy: unknown results, body height: 5 foot 2 inches (States she used to be 5 foot 2 inches, shrunk prior to vaccine). The outcome of the event rash that looks like measles was not recovered, while the outcome of the other event was unknown.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Other Meds:

Current Illness:

ID: 1000219
Sex: F
Age:
State: FL

Vax Date: 01/19/2021
Onset Date: 01/19/2021
Rec V Date: 02/04/2021
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: one of the nurses at the outpatient clinic where she works was positive for covid; Nausea; she started feeling a little warm; Low grade fever; Chills; This is a spontaneous report from a contactable nurse reporting for herself. A 67-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3302), intramuscularly on 19Jan2021 11:03 on right arm at single dose for COVID-19 immunization. Vaccination Facility Type was at Clinic. Medical history included just had rotator cuff repair surgery last Thursday (11Jan2021), pain, muscle relaxer. Concomitant medications included acetaminophen; hydrocodone as pain medicine, methocarbamol as muscle relaxer. Historical Vaccine included first dose of BNT162B2 (Lot number: EK9231) intramuscularly on 28Dec2020 at 9:52 am for COVID-19 immunization on right arm and experienced right arm soreness at the injection site. It was reported that last night (19Jan2021) she had a low grade fever and chills, then it went away, she was not having the chills earlier today and the fever went away. The fever had come back and she was chilled even though it was hot. She tested negative for coronavirus that Monday (08Jan2021) prior to the surgery. She was being told that one of the nurses at the outpatient clinic where she worked was positive for covid. She clarified that the fever and the chills go together and started last night. The fever did get better and she was not feeling feverish or chilled during the day. About 2 or 3 hours ago (20Jan2021) she started feeling a little warm, nauseated and she checked her temperature 30 minutes ago and it was 99.4. She always run low and did not have a fever. No treatment received for all events. The outcome of event low grade fever was resolving, outcome of events chills and nauseated were not resolved, outcome of other events were unknown.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events low grade fever, chills and nausea 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: ACETAMINOPHEN;HYDROCODONE; METHOCARBAMOL

Current Illness:

ID: 1000220
Sex: F
Age:
State: IN

Vax Date: 01/17/2021
Onset Date: 01/17/2021
Rec V Date: 02/04/2021
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: My body aches/My whole body is aching; Fast heartbeat; I have difficulty in breathing; This is a spontaneous report from a contactable consumer (patient). An 81-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249), via an unspecified route of administration from 17Jan2021 at 0.3 mL single for COVID-19 immunization. Medical history included immunotherapy for breathing, for her lungs. Concomitant medication included umeclidinium bromide, vilanterol trifenatate (ANORO) for immunotherapy for breathing. The patient whole body was aching from the shot (Later clarified as COVID 19 Vaccine Pfizer) that she got yesterday (on 17Jan2021). She had fast heart beats and she had difficulty in breathing and her whole body was really aching. Her whole body aches and pain of her body. The patient wanted to know how to get rid of the pain. The patient thought that she took treatment included Advil. And patient was still achy. The due date for next shot was on 07Feb2021. The patient underwent lab tests and procedures which included heart rate fast on 17Jan2021 and had lab work last week (in Jan2021), that was for her blood work. The outcome of the event whole body was aching was not recovered, of the rest events was unknown.

Other Meds: ANORO

Current Illness:

ID: 1000221
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 02/04/2021
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: chills; high anxiety; nervous wreck; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that the patient had some chills and high anxiety, also mentioned being a nervous wreck on an unspecified date. Outcome of the events was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1000222
Sex: M
Age:
State: TX

Vax Date: 01/16/2021
Onset Date: 01/17/2021
Rec V Date: 02/04/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Hives; This is a spontaneous report from a contactable consumer (patient). A 64-years-old male patient received second dose of bnt162b2 (BNT162B2, lot number: EL3249), via an unspecified route of administration on 16Jan2021 07:00 on Left upper Arm at SINGLE DOSE for covid-19 immunisation. Medical history included Blood pressure, High cholesterol, Asthma. Concomitant medication included losartan for high cholesterol, montelukast for asthma, valsartan for blood pressure. The patient woke-up at 5 AM with hives on 17Jan2021. The event was treated with Benadryl and have the hydrocortisone cream that went away and came back, that went away and came back and came back again in the morning of reporting date, so the consumer didn't know it's related. Investigation Assessment: No. The event outcome was not recovered.

Other Meds: LOSARTAN; MONTELUKAST; VALSARTAN

Current Illness:

ID: 1000223
Sex: F
Age:
State: ND

Vax Date:
Onset Date:
Rec V Date: 02/04/2021
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: dizzy; throwing up; Head spinning; nausea; This is a spontaneous report from a contactable nurse (patient). A 22-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL1284), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation. There were no medical history or concomitant medications. The patient started to get like extremely dizzy, was throwing up, head spinning, had horrible nausea; started to get really carsick on an unspecified date. The patient went into a walk in a clinic and that gave her ondansetron (ZOFRAN). So, she had been taking that for the nausea and the vomiting. She had also been taking meclozine (MECLIZINE) and dimenhydrinate (DRAMAMINE) too. The outcome of event dizzy was not recovered, while for other events was unknown.

Other Meds:

Current Illness:

ID: 1000224
Sex: F
Age:
State: CA

Vax Date: 01/15/2021
Onset Date: 01/16/2021
Rec V Date: 02/04/2021
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: I am kind of tired; Redness and little bit of swelling, a patch that is getting bigger just below the site where the injection was; Redness and little bit of swelling, a patch that is getting bigger just below the site where the injection was; Pain; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), Lot number: GL1283, on 15Jan2021 at 10 AM at single dose for COVID-19 immunization. The patient had some medical history, but not reported. Concomitant medications were not reported. Patient stated, she received her second dose of the COVID Pfizer vaccine (COVID 19 Vaccine) on Friday at 10 AM and usual it pained next day (16Jan2021) but they went away by the end of the day. However, she noticed that yesterday (17Jan2021) and today (18Jan2021) there was redness and little bit of swelling, a patch that was getting bigger just below the site where the injection was made. Yesterday it was smaller. Today the part was larger and little bit swollen So she thought she better see what's going on. Patient stated she was kind of tired. She was old. For treatment, the patient went to the drug store today and got some Benadryl. So, she took two Benadryl tablets at about three hours prior to the report and it hadn't effected it one way or the other. The patient didn't have any lab test. Patient's height was 5'5 and three quarters. The outcome of the events "Pain" and "Redness and little bit of swelling, a patch that is getting bigger just below the site where the injection was" was not recovered at the time of report. The outcome of tired was unknown.

Other Meds:

Current Illness:

ID: 1000225
Sex: F
Age:
State: FL

Vax Date: 01/15/2021
Onset Date: 01/01/2021
Rec V Date: 02/04/2021
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: Dizzy; She is not feeling well; When she went home she fell, she had a terrible fall and she got a terrible bruise on her head; When she went home she fell, she had a terrible fall and she got a terrible bruise on her head; Tired; This is a spontaneous report from a Pfizer-sponsored program via a contactable consumer (patient). A female patient of an unspecified age received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 15Jan2021 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. In Jan2021, the patient experienced dizzy, she was not feeling well, when she went home she fell, she had a terrible fall and she got a terrible bruise on her head, she also tired. The outcome of the events was unknown. Information about lot/batch number has been requested.

Other Meds:

Current Illness:

Date Died:

ID: 1000226
Sex: F
Age:
State: GA

Vax Date: 01/19/2021
Onset Date: 01/27/2021
Rec V Date: 02/04/2021
Hospital: Y

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: volvulus; volvulus and needed surgery followed by further ischemia; This is a spontaneous report from a contactable physician. An 86-year-old female patient received her first single dose of BNT162B2 (Pfizer-BioNTech Covid-19 vaccine) intramuscularly on 19Jan2021 for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had no known allergies. The patient developed volvulus and needed surgery followed by further ischemia and at end of life. The events onset date reported as 27Jan2021. Patient had 3days hospitalization and died eventually. It was unknown if an autopsy was performed. Information about lot/batch number has been requested.; Sender's Comments: Very limited information was provided in this report. No relevant information regarding the clinical course of the events, the patient's underlying medical conditions were mentioned. Based on the information currently available, lacking any other alternative explanations as so far, the reported volvulus and Intestinal ischaemia are managed as related to COVID-19 vaccine, BNT162B2, for reporting purpose, only. 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 RA, IEC, as appropriate.; Reported Cause(s) of Death: volvulus; ischemia

Other Meds:

Current Illness:

ID: 1000227
Sex: M
Age:
State: CA

Vax Date: 01/23/2021
Onset Date: 01/24/2021
Rec V Date: 02/04/2021
Hospital: Y

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: heart attack; This is a spontaneous report from a contactable consumer (patient). A 67-year-old male patient received bnt162b2 (BNT162B2, lot # EL9263) at single dose at left arm on 23Jan2021 14:15 for Covid-19 immunisation. Medical history included hypertension, high cholesterol. No known allergies. The patient had not experienced Covid-19 prior vaccination. There were no concomitant medications. The patient had not received any other vaccines within 4 weeks prior to the BNT162B2 vaccine. On 24Jan2021 06:00, the morning after he received the COVID-19 vaccine, he had a heart attack. The patient was hospitalized for heart attack for 2 days and evet was considered life threatening. The doctor placed 2 stents in his arteries. The patient underwent lab tests and procedures which included Sars-cov-2 test: negative on 24Jan2021.

Other Meds:

Current Illness:

Date Died: 01/26/2021

ID: 1000228
Sex: M
Age:
State: NV

Vax Date: 01/21/2021
Onset Date: 01/21/2021
Rec V Date: 02/04/2021
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: dead; Collapsed; bnt162b2 was given to patient with immunocompromised w/ reportable conditions; bnt162b2 was given to patient with immunocompromised w/ reportable conditions; This is a spontaneous report from a contactable nurse. A 40-year-old male patient receive first dose of bnt162b2 (Lot number: EK9231, Brand: Pfizer), intramuscular in left arm on 21Jan2021 15:15 at single dose for COVID-19 immunization. Medical history included immunocompromised w/ reportable conditions from an unknown date and unknown if ongoing, positive for Covid in September from Sep2020 to an unknown date. The patient's concomitant medications were not reported. The patient experienced dead, collapsed on 26Jan2021. Therapeutic measures were taken as a result of collapsed. The outcome of collapsed was unknown. The patient died on 26Jan2021. It was not reported if an autopsy was performed. Received Covid vaccine here on 21Jan2021, was at work on 26Jan2021 and collapsed, no known complaints at the time, CPR (cardiopulmonary resuscitation) was initiated immediately, transported to ER (Emergency room) and pronounced dead. Unknown if other vaccine in four weeks. The patient had COVID prior vaccination. Unknown If COVID tested post vaccination.; Sender's Comments: Based on the information currently provided, the patient was immunocompromised and had prior COVID infection. The death and syncope more likely are associated with the patient underlying medical conditions. More information such medical history, concomitant medications, treatment indication and event term details especially death cause and autopsy results are needed for fully medical assessment. 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.; Reported Cause(s) of Death: Dead

Other Meds:

Current Illness:

ID: 1000231
Sex: F
Age:
State: TX

Vax Date: 01/20/2021
Onset Date: 01/25/2021
Rec V Date: 02/04/2021
Hospital: Y

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: currently receiving IVIG for Acute Inflammatory Demyelinating Neuropathy; This is a spontaneous report from a contactable physician report for self. This 41-year-old no pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140), at left arm on 20Jan2021 at single dose for COVID-19 immunization. Medical history included Breast cancer (remission, 15 years ago), GERD, Hyperlipidemia. Concomitant medication not reported. Patient previously received second dose of Gardasil vaccine on 16Dec2020 at left arm and first dose of BNT162B2 (lot number: EJ1685) on 30Dec2020 08:15 AM at left arm. Five days after 2nd covid vaccine (on 25Jan202021 01:00 PM), patient started experiencing excruciating pain along the plantar aspects of both feet. This, with numbness and tingling ascended upwards (in a matter of hours) to lower back and arms. Patient went to local emergency room and was later transferred to (Institute name) for higher level of care. She was currently receiving IVIG for Acute Inflammatory Demyelinating Neuropathy. This is a GBS-like illness. Very debilitating, due to pain. No motor deficits yet. Hoping the IVIG stops the Demyelinating process in its tracks. The events resulted in hospitalization for 6 days. Patient received Nasal Swab covid test date on 25Jan2021 with result of "Negative". The outcome of events was not recovered.; Sender's Comments: Based on temporal association, a possible contributory role of BNT162B2 cannot be completely excluded for reported event acute inflammatory demyelinating neuropathy. 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: 1000232
Sex: M
Age:
State:

Vax Date: 01/14/2021
Onset Date: 01/01/2021
Rec V Date: 02/04/2021
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: On 14Jan2021, the patient received the second dose of BNT162B2 and the first dose on 28Dec2020; extreme blurriness in left eye; Nauseous; intense headache at the base of neck up to eye socket; This is a spontaneous report from a contactable consumer (reporting for himself). A 68-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EL8982), via an unspecified route of administration on 14Jan2021 at a single dose for COVID-19 immunization. Medical history and concomitant medications were none. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EL1284) on 28Dec2020 for COVID-19 immunization and experienced severe headache and was nauseous. The patient experienced extreme blurriness in left eye, nauseous, intense headache at the base of neck up to eye socket in Jan2021. On 14Jan2021, the patient received the second dose of BNT162B2 and the first dose on 28Dec2020. Therapeutic measures were taken as a result of extreme blurriness in left eye, nauseous, intense headache at the base of neck up to eye socket and included: ibuprofen 1000mg. The outcome of extreme blurriness in left eye, nauseous and on 14Jan2021, the patient received the second dose of BNT162B2 and the first dose on 28Dec2020 as unknown and of intense headache at the base of neck up to eye socket was recovered in Jan2021.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 636,615

Page last modified: 03 October 2021 5:28pm