VAERS 2021 Database www.vaers.hhs.gov

Main Page | All 2021 Deaths | Videos
VAERS Updated: 10/01/2021
** VAERS DATABASE Last updated: October 1, 2021**
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Manufacturers

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

Incidents per State

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

ID: 0918748
Sex: U
Age:
State:

Vax Date: 12/01/2020
Onset Date: 12/01/2020
Rec V Date: 01/04/2021
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: just kind of having blackout; Severe fatigue/fatigue; Severe myalgia; Some congestion; Severe headache; Haziness; This is a spontaneous report from a contactable other healthcare professional (HCP), who is also the patient. This patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in Dec2020 at single dose for COVID-19 immunisation. Relevant medical history and concomitant medications were not reported. In Dec2020, the patient experienced just kind of having blackout, severe fatigue, severe myalgia, some congestion, severe headache and haziness. On day six, symptoms improved and suddenly he/she was having symptoms again, severe myalgia, some congestion severe headaches and fatigue. The outcome of the events was unknown. The information about batch/lot number has been requested.; Sender's Comments: This report fails to include the basic information that is required for an independent medical evaluation. Assessment is postponed after receipt of a more complete case report. 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: 0918749
Sex: F
Age:
State:

Vax Date: 12/01/2020
Onset Date: 12/01/2020
Rec V Date: 01/04/2021
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: Flu like symptoms like myalgia, achy head, mental cloudiness; Flu like symptoms like myalgia, achy head, mental cloudiness; Flu like symptoms like myalgia, achy head, mental cloudiness; Flu like symptoms like myalgia, achy head, mental cloudiness; Deep cough; This is a spontaneous report from a non-contactable physician. A female patient of unspecified age received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date in Dec2020, in left upper arm like deltoid, for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date in Dec2020, immediately after receiving the vaccine, the patient experienced a deep cough which came on all of a sudden, followed 31 hours post vaccine by flu like symptoms like myalgias, achy head and mental cloudiness. She was feeling a bit better on 22Dec2020 morning and she was back at work. So, it was like a short couple of hours, maybe 24 hours turnaround. The events were resolving at the time of report. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported flu like symptoms like myalgias, achy head and mental cloudiness and the administration of the COVID 19 vaccine BNT162B2 based on the plausible temporal association. 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, as appropriate.

Other Meds:

Current Illness:

ID: 0918750
Sex: U
Age:
State:

Vax Date: 12/22/2020
Onset Date: 12/01/2020
Rec V Date: 01/04/2021
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: Urination bleeding; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162b2 (Solution for injection, lot number and expiration date not provided), via an unspecified route of administration at single dose on 22Dec2020 for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced urination bleeding in Dec2020 and wanted to know if it was going to be a side effect. The outcome of the event was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 0918751
Sex: F
Age:
State: CA

Vax Date: 12/19/2020
Onset Date: 12/19/2020
Rec V Date: 01/04/2021
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: severe fever; chills; severe night sweats; hives throughout my body; a rash on my face; This is a spontaneous report from a contactable nurse. This nurse reported for helf that the 37-year-old female patient received first dose of bnt162b2 (BNT162B2, product: COVID 19, brand: Pfizer), via an unspecified route of administration on Left Arm on 19Dec2020 10:30AM at single dose for covid-19 immunisation. No Pregnant at the time of vaccination. Medical history included Known Allergies to medications, food, or other products:Cocoa butter. Concomitant medications were unknown. Facility where the most recent COVID-19 vaccine was administered was Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient reported that "Starting seven hours after the vaccine, I experienced severe fever and chills. The next morning, despite multiple anti-pyretics, the fevers/chills were worse. Also I experienced severe night sweats, likely related to the fevers. Three days after the vaccine, I began to have hives throughout my body and a rash on my face. Responds to Benadryl, but eventually reappears." The event started from 19Dec2020 05:30 PM. Treatment was received for the adverse event included Anti-pyretics, anti-inflammatories, anti-histamine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Facility type vaccine was hospital. No other vaccine in four weeks. The patient recovered with lasting effects. No Covid prior vaccination. No Covid tested post: vaccination. The outcome of the event was recovered/resolved with sequel in Dec2020. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: The reported events severe fever and chills, severe night sweats, and hives and a rash on face were likely related to the use of first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), due to temporal relationship and clinical course. 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:

Current Illness:

ID: 0918753
Sex: F
Age:
State: MA

Vax Date: 12/16/2020
Onset Date: 12/17/2020
Rec V Date: 01/04/2021
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 erythema, Injection site pruritus, Injection site swelling, Injection site warmth

Symptoms: Left sides shock like pains in head. Lasts 3-5 seconds and go away. It's a stabbing shock like pain. Started on Thursday 17Dec2020 at 7:45 pm; Left sides shock like pains in head. Lasts 3-5 seconds and go away. It's a stabbing shock like pain. Started on Thursday 17Dec2020 at 7:45 pm; This is a spontaneous report from a contactable nurse reported for herself. A 28-year-old female patient (no pregnant) received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly in left arm on 16Dec2020 14:00 at single dose for COVID-19 immunization. Medical history was none. The patient's concomitant medications were not reported. The patient experienced left sides shock like pains in head, lasted 3-5 seconds and went away. It's a stabbing shock like pain. The events started on Thursday 17Dec2020 at 19:45. It was unknown whether treatment was received for the events. The events resulted in doctor or other healthcare professional office/clinic visit. The events were reported as non-serious. The most recent COVID-19 vaccine was administered in hospital. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was not recovered. Information on the lot/batch number has been requested.; Sender's Comments: Based on the compatible time association, the event left sides shock like pains in head is possibly related to suspect BNT162B2 administration. 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: 0918755
Sex: F
Age:
State: KS

Vax Date: 12/21/2020
Onset Date: 12/21/2020
Rec V Date: 01/04/2021
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 began to experience dizziness/shakiness.; patient began to experience dizziness/shakiness.; This is a spontaneous report from a non-contactable other hcp reporting for a patient. A 58-year-old female patient received first dose of BNT162B2 (Pfizer product, lot number: EH9899), intramuscular on 21Dec2020 16:00 at single dose on left arm for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that during her 15 minute waiting period after the injection (21Dec2020 16:15), the patient began to experience dizziness/shakiness. This provider was notified of patient reaction and she was then transferred to the emergency bay via wheelchair where she was assessed. Monitored patient for severe reaction symptoms, including rapid progression of symptoms, respiratory distress with dyspnea, increased work of breathing, persistent cough and cyanosis, vomiting, hypotension, dysrhythmia, chest pain and collapse. Treatment included no therapy, but did continue with vital checks at approximately 5 minute intervals. Patient discharge: stable to go home and follow up with PCP. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected; Sender's Comments: Based on the compatible time association, the dizziness and shakiness are possibly related to suspect BNT162B2 administration. 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: 0918758
Sex: F
Age:
State: NH

Vax Date: 12/21/2020
Onset Date: 12/22/2020
Rec V Date: 01/04/2021
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: Pyrexia, White blood cell count decreased

Symptoms: Small bowel obstruction with diffuse bowel and pelvic lymphadenopathy 36 hours after injection; Small bowel obstruction with diffuse bowel and pelvic lymphadenopathy 36 hours after injection; This is a spontaneous report from a contactable physician (patient). A 61-years-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EH9899), intramuscularly on 21Dec2020 12:30 to at single dose on left arm for COVID-19 immunization in hospital. Medical history included crohn's disease. No known allergies. Concomitant medications within 2 weeks of vaccination included estradiol, progesterone, colestipol hydrochloride (COLESTID), ustekinumab (STELARA), cyanocobalamin (B12). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced small bowel obstruction with diffuse bowel and pelvic lymphadenopathy 36 hours after injection on 22Dec2020 22:00 with outcome of recovered in Dec2020. The adverse events resulted in emergency room/department or urgent care, hospitalization for 3 days. Therapeutic measures were taken as a result of event included inpatient observation, nothing by mouth (reported as NPO), intravenous fluids. No COVID prior vaccination, COVID test nasal swab was negative on 23Dec2020 post vaccination. It was not reported as serious.; Sender's Comments: There is not a reasonable possibility that reported events small bowel obstruction and lymphadenopathy are related to BNT162B2 vaccine. The patient had underlying Crohn's disease, which put patient at risk of developing the event. 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: ; ; COLESTID; STELARA; B12 [CYANOCOBALAMIN]

Current Illness:

ID: 0918759
Sex: F
Age:
State: NC

Vax Date: 12/23/2020
Onset Date: 12/24/2020
Rec V Date: 01/04/2021
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: burst blood vessel in left eye/blood in her eye; This is a spontaneous report from a contactable physician (patient). A 35-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EH9899, expiry date 01Mar2021), via an unspecified route of administration on 23Dec2020 at single dose for covid-19 immunization. Vaccine location was left deltoid. The facility type vaccine was hospital. Medical history included ongoing rheumatoid arthritis for about 8 years. No known allergies. Patient didn't do relevant test. Concomitant medication included duloxetine hydrochloride (CYMBALTA) for rheumatoid arthritis for 2 years, sulfasalazine for rheumatoid arthritis for 4 months, it's unknown if they were ongoing. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received the vaccine yesterday (23Dec2020), which she was very excited about, but today (24Dec2020) she woke up with a burst blood vessel in her left eye, she appears to have blood in her eye. This has never happened to her before. She knows this can occur with patients that have COVID but didn't know if it was a side effect to receiving the vaccine. Patient didn't receive treatment for the adverse event. The action taken in response to the event for BNT162B2 was not applicable. The outcome of event was not recovered. The relatedness between COVID vaccine and event "burst blood vessel in left eye" was related by reporter. Pfizer is a marketing authorization holder of [BNT162B2] in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of [BNT162B2] has submitted the same report to the regulatory authorities.; Sender's Comments: "Burst blood vessel in eye" is not uncommon in general population, and there are many causes of the event. Considering temporal relationship, a contribution role of the injection of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) to the reported Eye haemorrhage cannot be excluded. 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: CYMBALTA;

Current Illness: Rheumatoid arthritis (for about 8 years)

ID: 0918760
Sex: M
Age:
State: FL

Vax Date: 12/17/2020
Onset Date: 12/17/2020
Rec V Date: 01/04/2021
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: Tachycardia; Intermittent palpitations; Low grade fever/fever; muscle aches; This is a spontaneous report from a contactable physician. A 27-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly in unknown arm on 17Dec2020 at single dose for routine mass immunizations (covid-19 immunization). The COVID-19 vaccine was administered at Hospital. Not a military facility. The patient's medical history was reported as none and concomitant medications was none (he was on no other medications). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced tachycardia, intermittent palpitations, low grade fever/fever all started somewhere in the morning of 18Dec2020 and muscle aches on 17Dec2020. Physician assessed tachycardia and intermittent palpitations as serious due to medically significant. Physician stated that one of his workers had the vaccine and proceeded to have tachycardia and low grade fever. He would like to know if patient should get the second dose. The patient had mostly tachycardia with some intermittent palpitations. Patient was seen in his office on 18Dec2020, and got the COVID vaccine on 17Dec2020. He also reported fever and muscle aches, although the fever was subjective and was not documented. Tachycardia improved and sent him to cardiology on 21Dec2020. It was not life threatening and they did an Electrocardiogram (EKG). His initial heart rate was 130. When he was seen again in their office on 21Dec2020, it was 93, which was baseline. It improved. He never got his temperature. The highest in office was 99.5 degrees Fahrenheit. He had some muscle aches. The physician just sent patient to cardiology because he was having intermittent tachycardia and intermittent palpitations. Two visits to physician office. He was seen on 18Dec2020 and again on 21Dec2020. Relevant tests: they did testing for tachycardia but not related specifically. They did thyroid and EKG in office and he did not know if test were back. EKG was ok. The Thyroid, Complete blood count (CBC) and lipid (all were on an unknown date in Dec2020) were not back and were just done to make sure there were no cardiac issues. The outcome of the events was recovering. The lot/batch number has been requested.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events tachycardia and palpitations cannot be excluded. 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: 0918761
Sex: F
Age:
State: VA

Vax Date: 12/21/2020
Onset Date: 12/24/2020
Rec V Date: 01/04/2021
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: Cellulitis: below left elbow; Soft tissue swelling; This is a spontaneous report from a contactable nurse (patient). A 63-year-old female patient (62 years old at time of vaccination) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EH9899), intramuscular in left upper arm on 21Dec2020 13:00 at a single dose for COVID-19 immunization administered in the hospital. Medical history included ongoing hypertension and cervical cancer from 2015 and ongoing. The patient has been taking unspecified concomitant medication/s. The patient previously took amoxicillin and had allergies and nausea. On 24Dec2020 16:00, patient had cellulitis below left elbow and soft tissue swelling. On 25Dec2020, patient went to ER and X-ray was taken and patient was prescribed Keflex 500mg 3x day. Prior to vaccination, the patient was not diagnosed with COVID-19: Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovering.; Sender's Comments: Based on the information currently provided, the vaccination with BNT162B2 might play a contributory role in triggering the onset of cellulitis. 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: Cervical cancer; Hypertension

ID: 0918762
Sex: F
Age:
State: OR

Vax Date: 12/21/2020
Onset Date: 12/26/2020
Rec V Date: 01/04/2021
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: congestion in the throat and upper lungs; congestion in the throat and upper lungs; This is a spontaneous report from a contactable other healthcare professional (patient). A 61-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK5730), intramuscular on the left arm on 21Dec2020 09:30 at a single dose for COVID-19 immunization. The patient's medical history included herpes 2. The patient was not pregnant. The patient had no known allergies to medications, food, or other products. There were no concomitant medications. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. On 26Dec2020 09:00, the patient experienced congestion in the throat and upper lungs. Oxygen level was 98 and temperature was 97.7. She had a good diet, no dairy, and no Christmas junk food, so for the patient, it was inexplicable. She was also consistent at mask wearing and all the precautions. No treatment was received for the adverse events. Outcome of the events was not recovered. The events were reported as non-serious.; Sender's Comments: Considering the temporal gap between the vaccination and the event onset, the Company considers the event pulmonary congestion is unlikely related to vaccination with BNT162B2. 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: 0918763
Sex: F
Age:
State: FL

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

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

Lab Data:

Allergies:

Symptom List: Rash, Urticaria

Symptoms: She was hospitalized for a month Occurred after a flu two months prior and a stomach flu 2-3 weeks prior; She was hospitalized for a month Occurred after a flu two months prior and a stomach flu 2-3 weeks prior; This is a spontaneous report from a contactable consumer. A 75-year-old female patient received bnt162b2 (BNT162B2, lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date at a single dose for covid-19 vaccination. Medical history included guillain-barre syndrome from 2011 at the age of 65 and Levaquin allergy. The patient's concomitant medications were not reported. On an unspecified date, the patient was hospitalized for a month that occurred after a flu two months prior and a stomach flu 2-3 weeks prior. The outcome of the events was unknown. Information about lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 0918764
Sex: F
Age:
State: NY

Vax Date: 12/20/2020
Onset Date: 12/01/2020
Rec V Date: 01/04/2021
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: I got my left arm pit, lump on it, I have bigger than 1 cm 2 lumps, hidradenitis/Pain under my arm; Patient received Pfizer Covid-19 Vaccine who is a nursing mom; Patient received Pfizer Covid-19 Vaccine who is a nursing mom; Mastitis; I got Myalgia all over the body, especially on my shoulders and back; I had chills but my temperature was normal; This is a spontaneous report from a contactable physician (patient herself). This physician reported information for herself (mother) and baby. This is the mother case. A 40-year-old female patient received her first dose of bnt162b2 (BNT162B2, also reported as Pfizer Covid-19 Vaccine, lot/batch number and expiry date were not reported), via an unspecified route of administration on 20Dec2020 18:30 at single dose for Covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient informed that she got in her left shoulder and left arm pit, lump on it. It was bigger than 1 cm 2 lumps, hidradenitis under her pits arm same size on 21Dec2020. She also reported that she was nursing mom to her self-kid which is 16 months old. She had Mastitis right now (20Dec2020) and informed that she hadn't it her life before. She got her vaccine on Sunday (20Dec2020) in night. She started to have pain under her arm on monday afternoon (21Dec2020) and then since yesterday (20Dec2020) she had mastitis. The mastitis in the right side, lump and the in the left side, which was the site of the vaccine. She never got a fever but got myalgia all over the body, especially on her shoulders and back and also she had chills but her temperature was normal. The outcome of events was unknown. Information on the Lot/Batch Number has been requested.; Sender's Comments: Based on the close temporal relationship, the association between the event mastitis with BNT162b2 can not be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2020520371 Fetal case

Other Meds:

Current Illness:

ID: 0918765
Sex: F
Age:
State: CA

Vax Date: 12/22/2020
Onset Date: 12/22/2020
Rec V Date: 01/04/2021
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: 26Dec2020 continued decreased perfusion added bilateral knee joint pain; 26Dec2020 continued decreased perfusion added bilateral knee joint pain; 25Dec2020 added facial edema; 24Dec2020 ++6 pitting edema on ankles and feet +3 pitting legs and abdomen; 24Dec2020 ++6 pitting edema on ankles and feet +3 pitting legs and abdomen; throat scratchy and tight; throat scratchy and tight; 23Dec2020 slight swelling on feet and ankles; 23Dec2020 slight swelling on feet and ankles; Tingling and best flutter 5 minutes after administration; Tingling and best flutter 5 minutes after administration; This is a spontaneous report from a contactable nurse (patient). A 48-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot/batch number: EJ1685, expiration date: Mar2021), intramuscularly on 22Dec2020 at 09:45 at single dose for COVID-19 immunization in hospital. The patient medical history included known allergies: Sulfa, Penicillin; fibromyalgia; hypertension; high cholesterol. Prior to vaccination, patient was not diagnosed with COVID-19. The patient's concomitant medications included other medications was received within 2 weeks of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced on 22Dec2020 09:45 tingling and best flutter 5 minutes after administration; 23Dec2020 slight swelling on feet and ankles; 24Dec2020 ++6 pitting edema on ankles and feet +3 pitting legs and abdomen, throat scratchy and tight; 25Dec2020 added facial edema; 26Dec2020 continued decreased perfusion added bilateral knee joint pain. Since the vaccination, patient had not been tested for COVID-19. Therapeutic measures were taken as result of the events included diphenhydramine hydrochloride (BENADRYL) 50 mg every 6 hours. The outcome of the events was not recovered. The report was reported as non-serious, with seriousness criteria-Results in death: No; Life threatening: No; Caused/prolonged hospitalization: No; Disabling/Incapacitating: No; Congenital anomaly/birth defect: No.; Sender's Comments: Flutter occurred 5 minutes after vaccination; a possible causal association between administration of the suspect vaccine bnt162b2 and the serious event onset cannot be fully 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: 0918766
Sex: F
Age:
State: MT

Vax Date: 12/18/2020
Onset Date: 12/18/2020
Rec V Date: 01/04/2021
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: dizzy/feel faint; perspiring; like blood not getting to my head; had to get on hands and knees, crawl; felt like my heart may be racing 10 min after vaccine/heart felt off beat and like blood not getting to my head/heart rate was 142; felt like my heart may be racing 10 min after vaccine/heart felt off beat and like blood not getting to my head/heart rate was 142; arm sore day #1 and #2- not unexpected; This is a spontaneous report from a contactable Physician(patient). A 48-year-old female patient received first dose (BNT162B2, lot number EK5730) , intramuscular at Arm Right on 18Dec2020 14:15 at the 48-year-old at single dose for COVID-19 immunization. The medical history included elevated blood pressure , allergic to sulfa, hypertension and Covid. The concomitant products included alprazolam, diphenhydramine hydrochloride (BENADRYL), spironolactone, metoprolol for hypertension, colecalciferol (VITAMIN D 3). The patient previously took nubaine and experienced drug allergy. The patient also happened to be a physician in private practice and received the vaccine at her local hospital. The patient had hypertension which was under excellent control on metoprolol 25 mg. She took it as prescribed every day surrounding the vaccine. On day #1 at the vaccine she felt like her heart may be racing 10 min after vaccine was about 80 on 18Dec2020 14:25. nothing serious. The patient experienced arm sore day #1 and #2 and not unexpected. On about 7 pm the day after the vaccine 19Dec2020 she was tachy at rate of about 105. She took her metoprolol heart rate never came down. At about 9:30 pm on 19Dec2020 when her rate should have been about70- she got up from couch after falling asleep. Upon standing felt like she was very dizzy. Walked upstairs, started to feel faint, perspiring, heart felt off beat and like blood not getting to my head. She had to get on hands and knees, crawl and heart rate was 142 and sustained for almost a minute. It took over an hour for it to come back to 86 and stayed there all night. There was not treatment to all of the adverse events. The outcome of the events was Recovering.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the palpitations, tachycardia and other reported events due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including EKG, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Other Meds: ; BENADRYL; ; ; VITAMIN D 3

Current Illness:

ID: 0918767
Sex: F
Age:
State: NY

Vax Date: 12/21/2020
Onset Date: 12/23/2020
Rec V Date: 01/04/2021
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: Severe rash; This is a spontaneous report from a contactable healthcare professional (patient). A 42-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK5730 (pending clarification)), intramuscularly at the left arm on 21Dec2020 at 16:00 (04:00 PM) at single dose for COVID-19 immunization. The patient was vaccinated at a hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not pregnant at the time of vaccination. The patient's medical history included Diabetic, type 1, allergies to penicillin, and the patient diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. The patient previously took codeine and experienced allergies. The patient received other unspecified medications within 2 weeks of vaccination. The patient experienced severe rash on 23Dec2020 at 21:30 (09:30 PM). The adverse event resulted in emergency room/department or urgent care: the patient was treated at local ER with prednisone and benadryl. The event was reported as non-serious. The patient recovered from the severe rash on an unspecified date in Dec2020.; Sender's Comments: Based on the information currently provided, the vaccination with BNT162B2 might play a contributory role in triggering the onset of severe rash. 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: 0918768
Sex: F
Age:
State: NY

Vax Date: 12/23/2020
Onset Date: 12/25/2020
Rec V Date: 01/04/2021
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: Diarrhea persisted 24 hours with mucous and bloody mucous after all fecal material was exhausted.; Did have one episode of chills; This is a spontaneous report from a contactable physician. A 51-year-old female patient received the first dose of bnt162b2 (BNT162B2) lot no: EK9231, intramuscular on 23Dec2020 09:45 at a single dose for COVID-19 immunization in workplace clinic. Medical history included hypothyroid, allergies from bee sting, and covid-19 from Apr2020, all unknown if ongoing. Concomitant medication included levothyroxine sodium (SYNTHROID). The patient did not receive other vaccine in four weeks. On 25Dec2020, in the late evening at 11:45 PM-almost midnight, the patient experienced diarrhea, severe, without nausea or vomiting. Did have one episode of chills that resolved. Diarrhea persisted 24 hours with mucous and bloody mucous after all fecal material was exhausted. The patient had COVID-19 in Apr2020 and had positive antibodies in Jun2020 with high titers. She confirmed with their ID chief that she should proceed to receive the vaccine. Diarrhea resolved in 24 hours. Some lingering increased GI activity. No fever (temp 99.0F) (Dec2020). The patient recovered from events without treatment in Dec2020. The events were reported as non-serious. The patient was not tested for COVID-19 post vaccination.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of diarrhea, severe cannot be excluded, considering the plausible temporal relationship and the known adverse profile of the suspect product. 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: 0918770
Sex: F
Age:
State: GA

Vax Date: 12/22/2020
Onset Date: 12/22/2020
Rec V Date: 01/04/2021
Hospital: Y

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: Difficulty breathing; This is a spontaneous report from a contactable pharmacist. A 54-year-old female patient received her first dose of intramuscular BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 22Dec2020 at 04:15 PM at single dose in left arm for COVID-19 immunisation at the age of 54-year-old. Lot number was ELO140. Medical history was unknown, concomitant medications were unspecified. Patient was not pregnant at the time of vaccination. On 22Dec2020 at 04:30 PM, the patient experienced difficulty in breathing, and she was hospitalized for one day. The patient was treated with EPI for the event. The patient was recovering from the event.; Sender's Comments: Based on the compatible temporal association, the Company considers the event difficulty in breathing is possibly related to vaccination with BNT162B2. 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: 0918772
Sex: F
Age:
State: IL

Vax Date: 12/23/2020
Onset Date: 12/24/2020
Rec V Date: 01/04/2021
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: short of breath; Intense headache; tiredness; body aches; This is a spontaneous report from a contactable other healthcare professional (patient). A 47-year-old female patient (not pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: ELO124), via an unspecified route of administration on 23Dec2020 at 14:30 on Left arm at single dose for COVID-19 immunization in hospital. The patient medical history included Rheumatoid arthritis, lupus. No known allergy, no allergies to medications, food, or other products. Prior to vaccination, patient was not diagnosed with COVID-19. Concomitant medications included baricitinib (OLUMIANT), hydroxychloroquine, prednisone. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced Intense headache, tiredness, body aches, short of breath on 24Dec2020; events were resulted in: Doctor or other healthcare professional office/clinic visit. Since the vaccination, patient had been tested for COVID-19 on 27Dec2020: Nasal Swab, result was unknown. No treatment was received for the events. The outcome of the events was not recovered.

Other Meds: OLUMIANT; ;

Current Illness:

ID: 0918773
Sex: F
Age:
State: UT

Vax Date: 12/20/2020
Onset Date: 12/20/2020
Rec V Date: 01/04/2021
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: have COVID; have COVID; bone-crushing-pain; fever; This is a spontaneous report from a contactable consumer reporting for a patient (nurse). A 47-year-old female patient received first single dose of BNT162B2 (Solution for injection, batch/lot number and exp date not reported), via an unspecified route of administration on 20Dec2020 for immunization. The patient's medical history concomitant medications were not reported (unknown). Patient was an ER Nurse and took first dose of vaccine and then described mild/moderate symptoms on day one only. On 23Dec2020, patient posted they have COVID (positive COVID test). Contracted from spouse who got it from work. She further described it as "hit by a truck." On Day 4 she describes her COVID symptoms: bone-crushing-pain when fever rises. Symptoms were COVID symptoms, not directly related to vaccine. The events/symptoms started on 20Dec2020. Patient had no Covid prior vaccination. The patient was COVID tested post vaccination. The patient considered the events as non-serious. The outcome of events was not recovered. Information on Lot/Batch number has been requested.

Other Meds:

Current Illness:

ID: 0918774
Sex: M
Age:
State: OR

Vax Date: 12/22/2020
Onset Date: 12/01/2020
Rec V Date: 01/04/2021
Hospital: Y

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: abdominal pain; nausea; high blood pressure; This is a spontaneous report from a contactable consumer. A 93-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140), via an unspecified route of administration on 22Dec2020 at a single dose for COVID-19 immunization. Medical history included diabetic and irritable bowel. The patient's concomitant medications were not reported. The patient received the COVID vaccine and had abdominal pain, nausea and high blood pressure within 12 to 18 hours of vaccine received. The events lead to nursing home to emergency room and admitted to hospital. The patient was hospitalized due to events since 23Dec2020. Outcome of the events was recovering.

Other Meds:

Current Illness:

ID: 0918775
Sex: F
Age:
State: WI

Vax Date: 12/19/2020
Onset Date: 12/26/2020
Rec V Date: 01/04/2021
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: Golf ball size lump in armpit of injection arm; This is a spontaneous report from a contactable nurse. A 49-year-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration on left arm on 19Dec2020 18:15 at SINGLE DOSE for COVID-19 immunization. There was no medical history reported. Concomitant medication included estradiol (ESTROGEN), and meloxicam. On 26Dec2020 08:00, the patient experienced golf ball size lump in armpit of injection arm. The patient did not receive treatment for the adverse event. The outcome of the event was not recovered. Information on the lot/batch number has been requested.

Other Meds: ESTROGEN;

Current Illness:

ID: 0918776
Sex: F
Age:
State: OK

Vax Date: 12/24/2020
Onset Date:
Rec V Date: 01/04/2021
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: I had seizure like 3 times; Vasovagal reaction; Fever; Headache; Weakness; It's just little bit shaky and breathless; It's just little bit shaky and breathless; allergic reaction; This is a spontaneous report from a contactable consumer. A 40-year-old female patient received bnt162b2 (BNT162B2, lot number: EK5730), via an unspecified route of administration on 24Dec2020 at a single dose for covid-19 vaccination. There were no relevant medical history and concomitant medications. The patient reported that on an unspecified date, she had an allergic reaction. She had vasovagal reaction and seizures. Vasovagal was an allergic reaction that happened, and added that basically it's an allergic reaction. The patient experienced fever, headache, and weakness like right now. It was just little bit shaky, ever since yesterday and she had been way off like she take it as instruction yesterday, weakness, headache and breathless did not stopped from yesterday. The patient had been taking Tylenol for fever and headache. The patient reported that the events persisted. On 24Dec2020, lab work was done at the hospital, and she was told that the lab work was okay and they did CT scan of head because she developed seizure. She had seizure like 3 times so they scanned her brain. The outcome of the events was not recovered.

Other Meds:

Current Illness:

ID: 0918778
Sex: F
Age:
State: CO

Vax Date: 12/17/2020
Onset Date: 12/18/2020
Rec V Date: 01/04/2021
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: developed a migraine; nausea; sensitivity to light and sound; sensitivity to light and sound; she developed significant loss of mental clarity (brain fog); On 18Dec in the AM, developed progressive severe soreness at injection site, worse than any other vaccine, hurt even just the the touch. This lasted about a total of 36 hours and progressively improve; brain fog; retroorbital headache/intermittent mild tension type frontal headache; This is a spontaneous report from a contactable physician (patient). A 29-year-old female patient received first dose BNT162B2 (lot number EH9899), via an unspecified route of administration on 17Dec2020 12:00 at 29 years old at single dose at Left arm for COVID-19 immunization. Medical history included Mirena IUD, personal and family history of retinal migraines (without headache). The concomitant medications were magnesium citrate, melatonin, ademetionine (SAME) and fish oil. On 18Dec2020 in the AM, developed progressive severe soreness at injection site, worse than any other vaccine, hurt even just the touch. This lasted about a total of 36 hours and progressively improved. There was no swelling, redness, or other local symptoms. In the afternoon on 18Dec2020, she developed significant loss of mental clarity (brain fog) while at work. In the evening on 18Dec2020, developed mild retroorbital headache (this was actually the first headache of my life). All day 19Dec2020 and about half the day of 20Dec2020 developed a migraine (also the first of my life), experienced as retroorbital pounding headache, sensitivity to light and sound in 19Dec2020, nausea without vomiting in 19Dec2020, and loss of mental clarity. She had intermittent mild tension type frontal headache on 20Dec2020 PM with all other symptoms resolved, all symptoms resolved by 21Dec2020 AM. The patient used naproxen 440 mg and Tylenol 1000 mg on 19Dec2020. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient was not Allergic to medications, food, or other products. The outcome of the events was recovered on 21Dec2020. The information on the batch number has been requested.; Sender's Comments: Based on information available, the reported loss of mental clarity together with other events was likely related to the first dose BNT162B2 due to temporal relationship and clinical course. 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: ; ; SAME [ADEMETIONINE];

Current Illness:

ID: 0918779
Sex: F
Age:
State: FL

Vax Date: 12/22/2020
Onset Date: 12/24/2020
Rec V Date: 01/04/2021
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: husband and daughter tested positive/after taking the shot, she was feeling sick and had a fever/wondering if the vaccine can give the reaction, or maybe she has the virus; husband and daughter tested positive/after taking the shot, she was feeling sick and had a fever/wondering if the vaccine can give the reaction, or maybe she has the virus; having a lot IO symptoms; fever; has been feeling "sick"; This is a spontaneous report from a contactable consumer. A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), via an unspecified route of administration on the left arm on 22Dec2020 at single dose for COVID-19 immunisation. The patient's husband and daughter tested positive (COVID-19). There were no concomitant medications. The patient stated, "had the first vaccine shot, later clarified as Pfizer COVID vaccine, on 22Dec2020, and didn't have any symptoms before that, her husband and daughter tested positive, but she was staying away from that, had no symptoms, but after taking the shot, on 24Dec2020, she was feeling sick and had a fever, and has had a fever ever since, and she is taking Tylenol and Motrin every six hours, and even then she still gets the fever, it hasn't stopped, she is having a lot IO symptoms, and is wondering if the vaccine can give the reaction, or maybe she has the virus. On 24Dec2020 is when the fever started and she was feeling sick. States she filled out a report online, on (Website)". The outcome of the events was not recovered.

Other Meds:

Current Illness: COVID-19 virus test positive (husband and daughter)

ID: 0918780
Sex: M
Age:
State: MD

Vax Date: 12/24/2020
Onset Date: 12/01/2020
Rec V Date: 01/04/2021
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: his gums became discolored and turned purple/gums (both sides up and down) remain purple/discoloration to the gums in his mouth; his mouth started hurting; feeling hot; Body aches; Fever; Pain to the gums in his mouth; muscle aches; sore throat; neck pain; This is a spontaneous report from a contactable nurse (patient). A 26-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration to right shoulder on 24Dec2020 11:30 at a single dose for COVID-19 immunization. There were no medical history and concomitant medications. The patient received vaccine on 24Dec2020. He experienced body aches, fever, and feeling hot with onset of about 3-4 hours after he was administered (24Dec2020). Next day (25Dec2020), his mouth started hurting, his gums became discolored and turned purple. Gums (both sides up and down) remained purple. He will be seeing a dentist. He also reported pain and discoloration to the gums in his mouth on 25Dec2020. He had been experiencing some of the regular side effects such as muscle aches, sore throat, neck pain on an unspecified date in Dec2020. Outcome of the event gum discoloration was not recovered, of the events feeling hot, generelized aching, and fever was recovered on 26Dec2020, of the event gum pain was recovering, and of the remaining events was unknown. He reported seriousness criteria as what he thinks to be medically significant at this point; that they could be medically significant. He is scheduled to receive the second dose of the product which at this point he does not plan to change. Dose change is unknown until he determines cause of these events and on what the doctor and dentist he is going to see recommend. He believes events could be caused by the vaccine. Information on the lot/batch number has been requested.; Sender's Comments: A causal association between BNT162 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: 0918782
Sex: F
Age:
State: NY

Vax Date:
Onset Date:
Rec V Date: 01/04/2021
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: extreme muscle ache that she couldn't move; I couldn't take the pain/severe body ache severe like I couldn't walk; I couldn't take the pain/severe body ache severe like I couldn't walk; extreme muscle ache that she couldn't move; High fever; Lot of chills; Itchiness; Hives; she was crying; This is a spontaneous report from a contactable Nurse (patient). A 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), intramuscular on an unspecified date at single dose for covid-19 immunization. Patient history was no and investigation assessment was no. There were no concomitant medications. The patient had hives and itchiness and then that was the first day that was after 8 minutes and then the next day the patient had severe body ache severe like I couldn't walk, she cried. The patient took Tylenol and Ibuprofen as she couldn't take the pain (further clarification was unknown). The patient had high fever 102.4 and was having a lot of chills. Start date of event was 24th, the 23rd she had the hives and the 24th she had the extreme muscle ache that she couldn't move and she was crying and she had the chills and the fever on the 24th. So it on started 23rd with the hives so then it started with the body aches and the fever on the 24th. Outcome of the events was recovered. The causality between the events and drug was considered as related by the reporter via Global Introspection. Information on the batch/lot number has been requested.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported body ache severe like I couldn't walk, extreme muscle ache that she couldn't move, and the administration of BNT162B2, based on the reasonable temporal association. 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.

Other Meds:

Current Illness:

ID: 0918783
Sex: M
Age:
State: TX

Vax Date: 12/21/2020
Onset Date: 12/21/2020
Rec V Date: 01/04/2021
Hospital: Y

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: left sided weakness; it has weakened his heart; stutter; severe stroke like symptoms; Ventricular tachycardia/help keep his heart rate at bay; Loss of balance; extreme numbness and tingling in left hand and foot; tingling in left hand and foot; oral motor impairment; mouth weakness and not coordinated/mouth is fatigued easily; Issues finding words and trouble speaking; Issues finding words and trouble speaking; Ejection fraction down to 25%; The initial case was missing the following minimum criteria: adverse event. Upon receipt of follow-up information on 28Dec2020, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable other healthcare professional (HCP). A 29-years-old male patient received bnt162b2 (lot number: EJ1685), intramuscular (deltoid left) on 21Dec2020 at 05:30 at 0.3 mL single (first dose) for Covid. Medical history was reported as "none". Concomitant medications were not reported. The patient previously received Flu vaccine in Oct2020 for immunization. The patient is an Occupational Therapist, and he called to report an adverse event that he experienced with the first dose of the COVID Vaccine. He received the vaccine last Monday, 21Dec2020 at 5:30AM before his shift at work, then 20 minutes later, he was having severe stroke like symptoms. He experienced severe left sided weakness, loss of balance, extreme numbness and tingling in his left hand and foot, he had issues finding his words and he couldn't speak, and he had an oral motor impairment where his mouth was weak and not coordinated. The staff at the hospital did a neurological exam on him, and he failed, so he had to go to the emergency room (ER). The patient added that he was already in the hospital when this happened, and the ER doctors suspected that he had a CVA, and they gave him TPA to prevent any permanent brain damage and it worked. The patient then added that due to the shock of this whole event, from everything that happened, it has weakened his heart. Reportedly, he is a healthy 29 year old man, with no preexisting conditions, and he works out, and he has no heart conditions, but he had to get a cardiology follow up a few days after he got the vaccine, because he started going in to Ventricular Tachycardia, which he had never had in his life. So, the doctors at the hospital went ahead and did an Echocardiogram and an EKG, and he was told that his Ejection Fraction is down to 25%. He stated his heart is so weak, that he cannot work right now, but the structure of his heart is fine and has not had any damage. The hospital staff thought that maybe the patient had a chronic heart issue that he just did not know about, and that the stress of this event maybe made it kick into overdrive, but he states that the cardiologist said that was not the case, because the structure of his heart is fine, and the only thing they can see is that the heart is pumping weak. One physician even suggested that due to the shock of the event, he might have Takotsubo Cardiomyopathy, which is a broken heart, but because the structure of his heart is okay, it should be reversible. He stated that he is hoping he will heal up good, because he is young and has no pre-existing conditions. He added that his heart is in such a state right now; he has to wear an external defibrillator. The patient stated that all these happened about 20 minutes after he received the vaccine, and he was admitted to the hospital from 21Dec2020 to 25Dec2020. His neurological symptoms have resolved except that he has a stutter that he did not have before and his mouth is fatigued easily, so he has to slow down when he is eating, but now he can eat regular for the most part. The patient confirmed that he was not specifically prescribed the product; it was administered to him at his place of work, but it was optional. He stated he considered how he is working with COVID patients every day, and given the circumstance, he thought that it would be a best practice for him to get the vaccine. He had not gone to his primary care doctor in a while because he had been fine and healthy, but he called them and found out that his primary care had retired, so he has to find a new one now. Regarding the issues finding words and trouble speaking, he stated that he has improved, but it is still ongoing, he is just stuck in a plateau zone. With the Ventricular Tachycardia, he stated that this is an ongoing issue, as he has to wear the life vest even though he has no need to activate it yet. He did have one minor bought of the VTach, but because he is a therapist, he knows how to take care of it with relaxation techniques, he knows how to manage it. He had one bought of VTach the evening prior, but he was able to get it under control. The doctors have him on medication to help keep his heart rate at bay. He has never had to use medication before and is on the following medications to help keep his heart rate at bay: Metoprolol 25mg one tablet once daily by mouth and Lisinopril 5mg one tablet once daily by mouth. The VTach has improved, it was good enough he was able to discharge home, but it is still a concern. His cardiologist said that, basically his hope, is that once his body recover from the whole shock of everything, then his ejection fraction will heal, and his heart will heal. He again stated that the doctor told him that the structure of his heart is perfectly fine; he has thick walls in his heart, no leaking valves, and the heart was not conducting any abnormal signals. The doctor just said that right now, his heart is super weak and that it is an acute problem. With the Takotsubo Cardiomyopathy, he states that two doctors mentioned this diagnosis, but he confirmed that he was not actually diagnosed with this issue, he was just diagnosed with Ventricular Tachycardia. The outcome of the ejection fraction down to 25% was unknown to the patient at this time as he has not had another EKG or echocardiogram, but the cardiologist told him that the cardiologist expects that this will not be resolved quickly anyway. The patient confirmed that he did not receive any other vaccines on the same day he received the COVID vaccine. The only other vaccine he had this year was the flu vaccine which he got back in Oct2020. He has gone on to his online portal and there are the bloodwork results and all the imaging results on there from his CTs and MRIs, but he did not see the EKG or Echocardiogram results yet. He does not have this pulled up at this time, but he does have access to this stuff and can provide it later, if requested. He is curious about the next steps from here to how his case is processed. He is also curious if this information would help Pfizer make modifications to the vaccine if it is found that a lot of people are having the same reaction as he did. He is also wondering, given his situation, that probably he is not going to get the second dose, for his safety, but he is wondering what percentage of effectiveness the first dose does having just covered. The events left sided weakness, loss of balance, extreme numbness and tingling in left hand and foot resolved on 25Dec2020; severe stroke like symptoms and oral motor impairment; mouth weakness and not coordinated/mouth is fatigued easily resolved in 2020. The events ventricular tachycardia/help keep his heart rate at bay and issues finding words and trouble speaking were resolving, stutter had not resolved while the outcome of the events it has weakened his heart, and ejection fraction down to 25% was unknown.; Sender's Comments: The reported information is unclear and does not allowa meaningful assessment of the case. It will be reassessed upon receipt of follow up information. 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: 0918784
Sex: F
Age:
State: CT

Vax Date: 12/16/2020
Onset Date: 12/22/2020
Rec V Date: 01/04/2021
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: Left sided hearing loss; This is a spontaneous report from a contactable physician who was also the patient. A 42-year-old non-pregnant female patient received bnt162b2, lot number and expiration date were unknown, via an unspecified route of administration on 16Dec2020 , 8:30 at a single dose for covid-19 immunization. The patient's medical history included antiphospholipid antibody from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On 22Dec2020, the patient experienced left sided hearing loss. It was unknown if patient received treatment for the event. The outcome of the event was not recovered. The patient was not diagnosed with COVID prior to vaccination and has not been tested for COVID-19 since vaccination. Patient has no allergies. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Information on the lot/batch number has been requested.; Sender's Comments: As an individual case report there is not enough evidence to establish a causal relationship with the suspect vaccine. Currently there is no clear biological plausibility between the vaccine use and the even onset. More information such as complete medical history and concomitant medications 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.

Other Meds:

Current Illness:

ID: 0918786
Sex: F
Age:
State: RI

Vax Date: 12/27/2020
Onset Date: 12/27/2020
Rec V Date: 01/04/2021
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: tightness in throat and lump in throat/had a tightness and lump in her throat; tightness in throat and lump in throat/had a tightness and lump in her throat; allergic reaction like rash, tightness in throat, and lump in throat; allergic reaction like rash/red rash on her chest and rash was on her arms too; cheeks were flushed; This is a spontaneous report from a contactable nurse (patient). This nurse reported similar events for 3 patients. This is the first of 3 reports. A 23-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number: EK9231, intramuscular in the right deltoid, first dose on 27Dec2020 14:15 at a single dose for covid-19 prevention. Medical history included ongoing asthma and reactive airway which she was diagnosed when she was like 5 years old (2002). Concomitant medication included albuterol [salbutamol] for asthma which started when she was 8 years old or so. The patient wanted to know if she can receive the second dose of covid vaccine after experiencing symptoms of allergic reaction like rash, tightness in throat, and lump in throat. She wanted to know the ingredients and specific proteins in the covid vaccine. The patient received the COVID Vaccine and she developed a reaction. On 27Dec2020, she had a red rash on her chest, and her cheeks were flushed, and the rash was on her arms too, and she had a tightness and lump in her throat, it was not painful to swallow but she could feel the pressure with swallowing. She stated that she did not experience shortness of breath, but regardless, she was seen in the ER and she was given IV SOLUMEDROL, and BENADRYL, and she was watched for 5 or 6 hours and then she was sent home with an Epi Pen, around the clock Benadryl, and prednisone. She asked the ER doctors if they thought it was okay for her to receive the second dose of the product, and they told her to contact employee health for that question. She mentioned that she contacted that employee health and was told to contact her primary care provide which she did. Her primary care doctor instructed the caller to call Pfizer and gather some more information regarding ingredients, as the she may have had the reaction to a particular protein filler. She was also wondering if this is a known reaction to the product. She received the vaccine on 27Dec2020 at 2:15 PM. She reported that the red rash on her chest and arms, and her cheeks being flushed, resolved yesterday after receiving IV BENADRYL. Had a tightness and lump in her throat which was still ongoing, and it was kind of off and on and when the she takes Benadryl it goes away. She reported that this one is medically significant because even though she did not have shortness of breath, it could have affected her airway. She confirmed that she received no other vaccines on the same day as the COVID vaccine. The outcome of the events 'had a tightness and lump in her throat', allergic reaction was not recovered (a s reported); while recovered on 27Dec2020 for allergic reaction like rash/red rash on her chest and rash was on her arms too and cheeks were flushed.; Sender's Comments: Based on temporal association, the causal relationship between bnt162b2 and the events throat tightness, sensation of foreign body, allergy to vaccine, rash erythematous and flushing cannot be excluded. 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.,Linked Report(s) : US-PFIZER INC-2020517134 different patient, same drug and same event;US-PFIZER INC-2020517133 different patient, same drug and same event.

Other Meds: ALBUTEROL [SALBUTAMOL]

Current Illness: Asthma; Reactive airways disease

ID: 0918787
Sex: F
Age:
State: AZ

Vax Date: 12/27/2020
Onset Date: 12/27/2020
Rec V Date: 01/04/2021
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: Fever up to 120F; Bodyaches; Headache; dulled taste and smell; dulled taste and smell; Pain at the injection site; This is a spontaneous report from a contactable other HCP. A 25-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (reported as COVID 19 vaccine), intramuscular on 27Dec2020 12:00PM at single dose for covid-19 immunization. Vaccine location was left arm and it was the first dose. The patient medical history was not reported. Concomitant medication included influenza vaccine (FLU) on 16Dec2020 at right arm. Patient was not diagnosed with COVID-19 prior to vaccination nor tested for COVID-19 since the vaccination. The patient didn't receive any other medications within 2 weeks of vaccination. The patient experienced fever up to 120F, bodyaches, headache, dulled taste and smell, pain at the injection site on 27Dec2020. Patient didn't receive treatment for the adverse events. The action taken in response to the events for BNT162B2 was not applicable. The outcome of events was not recovered. The events were reported as non-serious. Pfizer is a marketing authorization holder of [BNT162B2] in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of [BNT162B2] has submitted the same report to the regulatory authorities. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: A causal association between BNT162B2 and the event hyperpyrexia cannot be excluded based on 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: 0918788
Sex: F
Age:
State: CA

Vax Date: 12/22/2020
Onset Date: 12/23/2020
Rec V Date: 01/04/2021
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: High blood pressure 187/95; Heart rate at one time 210 bpm; chest pain; Shortness of breath; This is a spontaneous report from a contactable pharmacist (patient) reported for herself that a 45-years-old female patient received first dose of BNT162B2 (lot number: EH9899), via intramuscular in left arm on 22Dec2020 07:00 AM at single dose for COVID-19 immunization. The patient was not pregnant. No known allergies. No allergies to medications, food, or other products. No other vaccine was received within 4 weeks prior to the COVID vaccine. No other medications were received within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior vaccination and patient was not tested for COVID-19 since the vaccination. There were no medical history or concomitant medications. The patient experienced high blood pressure 187/95, heart rate at one time 210 bpm, shortness of breath and chest pain on 23Dec2020 10:00 AM. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Treatment was received for heart rate at one time 210 bpm which included lab works and medication given propranolol to decrease heart rate. The outcome of the event was recovering.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events hypertension, heart rate increased, chest pain and dyspnoea cannot be excluded. The information available in this report is limited and 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: 0918789
Sex: F
Age:
State: MA

Vax Date: 12/18/2020
Onset Date: 12/01/2020
Rec V Date: 01/04/2021
Hospital: Y

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: She had an immediate reaction of accelerated heart rate and elevated blood pressure; She has very slightly elevated heart enzymes.; She had an immediate reaction of accelerated heart rate and elevated blood pressure; She's very anxious and very anxious tonight being alone at the hospital.; This is a spontaneous report from a contactable consumer (patient's father). A 30-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 18Dec2020 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had an immediate reaction of accelerated heart rate and elevated blood pressure. She was monitored for an hour and it subsided. On unspecified date in Dec2020 at 1:00am in the morning she had racing heart rate and went to ER. She was still in hospital. Things were not entirely stabilized. She had very slightly elevated heart enzymes in Dec2020 with outcome of unknown. They keep her overnight for an echocardiogram in morning. The patient was very anxious being alone at the hospital. Caller questioned if this has been reported with the vaccine. Lot/Batch and Expiry date has been requested.

Other Meds:

Current Illness:

ID: 0918790
Sex: F
Age:
State: CA

Vax Date: 12/19/2020
Onset Date: 12/19/2020
Rec V Date: 01/04/2021
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: mental cloudiness; bruising of injection site; arm pain; fatigue; This is a spontaneous report from non-contactable Pharmacist (patient). A 33-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) intramuscular at right arm on 19Dec2020 08:15 at single dose for Covid-19 immunization. The Covid-19 vaccine was administered in a hospital facility. Medical history included seasonal allergies, heartburn, and allergies to ethanol. The patient has no Covid prior vaccination. Concomitant medication included cetirizine, esomeprazole, melatonin; all from unspecified date for unspecified indication. The patient did not receive other vaccines in four weeks prior to the Covid vaccine. On 19Dec2020 at 15:00, the patient experienced bruising of injection site (x 1 week), arm pain, fatigue, mental cloudiness (approximately x 1 day). The patient was not tested post vaccination. The patient did not received treatment due to the events. The outcome of the events mental cloudiness, bruising of injection site, arm pain and fatigue was recovered in Dec2020. No follow-up attempts are possible. Information about lot/batch number cannot be obtained.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the event mental impairment cannot be excluded. The information available in this report is limited and 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: 0918791
Sex: F
Age:
State: MA

Vax Date: 12/19/2020
Onset Date: 12/19/2020
Rec V Date: 01/04/2021
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: 30 minutes after receiving vaccine, patient reported heart racing, dizziness, flushing, burning pain in her chest, dizziness. tachycardia, nausea and throat tightness; 30 minutes after receiving vaccine, patient reported heart racing, dizziness, flushing, burning pain in her chest, dizziness. tachycardia, nausea and throat tightness; 30 minutes after receiving vaccine, patient reported heart racing, dizziness, flushing, burning pain in her chest, dizziness. tachycardia, nausea and throat tightness; 30 minutes after receiving vaccine, patient reported heart racing, dizziness, flushing, burning pain in her chest, dizziness. tachycardia, nausea and throat tightness; 30 minutes after receiving vaccine, patient reported heart racing, dizziness, flushing, burning pain in her chest, dizziness. tachycardia, nausea and throat tightness; 30 minutes after receiving vaccine, patient reported heart racing, dizziness, flushing, burning pain in her chest, dizziness. tachycardia, nausea and throat tightness; 30 minutes after receiving vaccine, patient reported heart racing, dizziness, flushing, burning pain in her chest, dizziness. tachycardia, nausea and throat tightness; This is a spontaneous report from a contactable pharmacist. A 58-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number= EH9899), intramuscular on 19Dec2020 07:00 at SINGLE DOSE at Left arm for covid-19 immunization. Medical history included breast cancer female and allergies to shell fish and Latex. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. 30 minutes after receiving vaccine on 19Dec2020 07:30 am, patient reported 'heart racing, dizziness, flushing, burning pain in her chest, dizziness. tachycardia, nausea and throat tightness. Patient was taken to the ED where she received IV Benadryl and was observed for 4 hours. Patient was discharged home and symptoms subsided. The events resulted in emergency room/department or urgent care. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. Outcome of the events was recovered in Dec2020.; Sender's Comments: There is a plausible temporal relationship between immunization and onset of allergic reaction in a subject with a positive medical history for allergy to food (shellfish); causality cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Other Meds:

Current Illness:

ID: 0918792
Sex: M
Age:
State:

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

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

Lab Data:

Allergies:

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

Symptoms: exacerbation of cryptogenic organizing pneumonia; fever; malaise; wheezing; This is a spontaneous report from a contactable physician reported for himself. A 60-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration from an unspecified date at single dose for Covid-19 immunization. Medical history included rheumatoid arthritis. The patient's concomitant medications were not reported. The patient experienced having fever and malaise after vaccination and then a few days later he has been wheezing. The patient believed it was an exacerbation of cryptogenic organizing pneumonia. The outcome of the events exacerbation of cryptogenic organizing pneumonia, fever, malaise and wheezing was unknown. Follow-up activities are possible, information on the batch number has been requested.; Sender's Comments: The association between the event cryptogenic organizing pneumonia with BNT162b2 can not be fully 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: 0918793
Sex: M
Age:
State: NC

Vax Date: 12/21/2020
Onset Date: 12/01/2020
Rec V Date: 01/04/2021
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: Cough, Limb discomfort, Pain, SARS-CoV-2 test positive

Symptoms: Sudden onset Acoustic Neuritis without Labyrinthitis, hyperacusis, loss of hearing, fullness in ears, dizziness and tinnitus.; Sudden onset Acoustic Neuritis without Labyrinthitis, hyperacusis, loss of hearing, fullness in ears, dizziness and tinnitus.; Sudden onset Acoustic Neuritis without Labyrinthitis, hyperacusis, loss of hearing, fullness in ears, dizziness and tinnitus.; Sudden onset Acoustic Neuritis without Labyrinthitis, hyperacusis, loss of hearing, fullness in ears, dizziness and tinnitus.; Sudden onset Acoustic Neuritis without Labyrinthitis, hyperacusis, loss of hearing, fullness in ears, dizziness and tinnitus.; sore arm; nerve related hearing loss; This is a spontaneous report from a contactable physician reporting for himself. A 69-years-old male patient received bnt162b2 (BNT162B2; Lot : EKS730) vaccine , intramuscular in the left deltoid on 21Dec2020 15:30 at single dose for covid-19 immunisation . Medical history included atrial fibrillation from 2009. There were no concomitant medications. The patient stated he experienced sore arm on the same day 21Dec2020 and this was not a big deal. On 26Dec2020 the patient experienced sudden onset of acoustic neuritis without labyrinthitis, hyperacusis, fullness in ears, dizziness and tinnitus . The patient also experienced nerve related hearing loss from Dec2020. Sore arm was considered non serious events, while the remaining were considered Important Medical Events. The outcome of nerve related hearing loss was recovered, the outcome of sore arm was unknown, while the outcome of the remaining events was recovering.; Sender's Comments: Based on the temporal association, it cannot be fully excluded that the vaccination with BNT162B2 might play a contributory role in the events onset. 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: 0918794
Sex: F
Age:
State: TN

Vax Date: 12/25/2020
Onset Date: 12/25/2020
Rec V Date: 01/04/2021
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: I have lost hearing in my right ear; the right side of my face was numb; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Batch/lot number number EJ1685, expiration date Mar2021, on 25Dec2020 09:30 at single dose on left arm for Covid-19 vaccination. Medical history and concomitant medications were none. The patient had not received other vaccine in four weeks. The patient had no covid prior vaccination. The patient had no covid tested post vaccination. The patient received her first Covid-19 vaccination on Christmas morning. She worked at a medical center. Within an hour of when she got home, she lost hearing in one ear and also had some numbness on the same side of her face, She was wondering if that was something she should be concerned and she still didn't have hearing in her right ear. Treatment received for the events included Tylenol. The outcome of the events was not resolved.

Other Meds:

Current Illness:

ID: 0918795
Sex: F
Age:
State: CA

Vax Date: 12/19/2020
Onset Date: 12/01/2020
Rec V Date: 01/04/2021
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: She suspected that she had an undiagnosed autoimmune disease.; Spinal pain that elicits nausea; spinal pain that elicits nausea; Headache that is worse at night/Headache worse at night time, sometimes gets better during the day/bad head ache; Body aches; Feeling crappy; Low grade fever; Pressure in the head; Terrible pain; Neck pain; This is a spontaneous report from a contactable other health professional (patient). A 43-yearsold female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 19Dec2020 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received Covid19 vaccine on 19Dec2020 and reported that at 36 hours she had body aches, feeling crappy, and low grade fever in Dec2020, she had since developed at headache that is worse at night, and spinal pain that elicits nausea. She suspected that she had an undiagnosed autoimmune disease. She was inquiring about duration of the reported AE's from clinical trials, and tried to decide how long she will feel this way. And going on 10 days and she's just struggling, bad headache and neck pain headache worse at night time, sometimes gets better during the day. Terrible pain and nausea. Any info on length of side effects: 36 hours- body aches feeling crappy. Low grade fever. Nausea with the spinal pain, pressure in the head. Difference in people with autoimmune issues- infertility - suspected autoimmune. The outcome of the events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based on the information currently available, there is no biological plausibility to implicate the suspect vaccine to the occurrence of the serious event autoimmune disease. More information such as medical history and concomitant medications and confirmative diagnostic workups are needed for full medial 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.

Other Meds:

Current Illness:

ID: 0918797
Sex: F
Age:
State: GA

Vax Date: 12/22/2020
Onset Date: 12/22/2020
Rec V Date: 01/04/2021
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: Heart rate high; Blood pressure high; bruise at the site of the vaccination; This is a spontaneous report from a contactable other health professional reporting for herself. A female patient of an unspecified age received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration, on 22Dec2020, at single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On 22Dec2020, 1-1.5 hours after vaccination, the patient experienced heart rate high with outcome of unknown , blood pressure high with outcome of unknown and bruise at the site of the vaccination with outcome of unknown. The patient underwent lab tests and procedures which included: blood pressure, high (22Dec2020); heart rate, high (22Dec2020). She returned to the emergency room (ER) of the hospital where she received the vaccine due to all the events. Therapeutic measures were taken as a result of heart rate high and blood pressure high and included treatment with a beta blocker. The patient was also prescribed with a blood pressure medicine from the ER physician. The events heart rate high and blood pressure high were considered medically significant. The information on the lot/batch number has been requested.; Sender's Comments: Based on the compatible temporal association, the Company considers the events heart rate high and blood pressure high are possibly related to vaccination with BNT162B2. 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: 0918798
Sex: F
Age:
State:

Vax Date: 12/21/2020
Onset Date: 12/21/2020
Rec V Date: 01/04/2021
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: tingling of the lips/Lips tingled; Throat got tight; This is a spontaneous report from a contactable other hcp(patient). The 49-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK5730, Expiry Date: 31Mar2021), via an unspecified route of administration at left arm on 21Dec2020 at single dose for COVID-19 immunization. There were no concomitant medications nor medical history. Patient got first dose of the COVID vaccine and experienced her lips tingled/ tingling of the lips and her throat got tight, both on 21Dec2020, led to medically significant, lasted about 20 minutes. They observed her and she did not need any further treatment. Outcome of events was recovered in 21Dec2020.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of her lips tingled/ tingling of the lips and her throat got tight cannot be excluded, considering the plausible temporal relationship and the known adverse event (anaphylactic adverse reaction) profile of the suspect product. 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: 0918799
Sex: F
Age:
State: NY

Vax Date: 12/23/2020
Onset Date: 12/24/2020
Rec V Date: 01/04/2021
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: disoriented; hit her head and cut herself; hit her head and cut herself; Passed out at night; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), via an unspecified route of administration on 23Dec2020 at single dose at left arm for COVID-19 immunization. Medical history included Atrial fibrillation/heart problems diagnosed prior to the vaccine, got the COVID virus on 18Nov2020, disoriented in Nov2020. Concomitant medications included her heart medication every day and vitamins, nothing out of the normal. Caller stated she had heart problems. The heart problems were diagnosed prior to the vaccine. Caller also stated that she got the COVID virus this year before the vaccine as well and she was off, of work for like a month. On 23Dec2020 she got the vaccine. Then on Thursday 24Dec2020 and Friday 25Dec2020 she had a reaction. She had passed out in the night, hit her head and cut herself, she was then disoriented for 1 full day. Caller stated that the last time she was disoriented like this was when she had the COVID Virus, because she had heart problems. Caller stated that she was fine now. Caller stated that she had been off, of work so much. The heart problem she had was Atrial Fibrillation. Caller clarified that she had the COVID virus this year in Nov2020, it was before thanksgiving, on 18Nov2020 she had the virus, then on 19Nov2020 she got tested and it was positive. She got the vaccine on the 23Dec2020 Wednesday then on 24Dec2020 at night she passed out and on 25Dec2020 she was disoriented all day. Investigation Assessment: No. On 24Dec2020 she was going to bathroom, and found herself on the floor, then the following day 25Dec2020 was when she was disoriented. She knew this because when she had the actual COVID virus previous in Nov2020 this happened previously. When queried outcome of being disoriented she stated that she still felt a little weird but if getting better very, very slow. The Second dose was schedule for 13Jan2021. Caller confirmed that she did have a Positive Test for Covid Previously. Her treatment at the time was in the Emergency Room, they gave her an Antibody infusion, she had to schedule it because it was actually a clinical trial. Caller was asked if she knew the name of covid test, she stated that she does not know, she only recalled that she opened her mouth and they test her that way. The outcome of the event "disoriented" was recovering, of the other events was unknown.

Other Meds:

Current Illness:

ID: 0918800
Sex: U
Age:
State: MD

Vax Date: 12/01/2020
Onset Date: 12/01/2020
Rec V Date: 01/04/2021
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: Bells Palsy; This is a spontaneous report from a contactable consumer. This consumer reported similar events for three patients. This is 1st of three reports. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (also reported as Comirnaty), via an unspecified route of administration on an unspecified in Dec2020 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced bells palsy on Dec2020. The action taken in response to the event for bnt162b2 was not applicable. The outcome of event was unknown. No follow-up attempts are possible; information about batch/lot number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020519118 same reporter/drug/event, different patient;US-PFIZER INC-2020519119 same reporter/drug/event, different patient

Other Meds:

Current Illness:

ID: 0918801
Sex: U
Age:
State: MD

Vax Date: 12/01/2020
Onset Date: 12/01/2020
Rec V Date: 01/04/2021
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: Bell's Palsy; This is a spontaneous report from a contactable consumer or other non HCP. This consumer reported same events for three patients (nurses). This is 2nd of 3 reports. A patient of an unknown age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, also reported as COMIRNATY), via an unspecified route of administration on unknown date in Dec2020 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were unknown. Healthcare worker reported that 3 nurses who work in her facility received Pfizer's COVID vaccine last week (Dec2020) came in with Bell's Palsy in Dec2020. Event took place after use of product. The outcome of event was unknown. No follow-up attempts are possible. Information about batch/Lot number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020519105 same reporter, same drug, same event, different patients;US-PFIZER INC-2020519119 same reporter, same drug, same event, different patients

Other Meds:

Current Illness:

ID: 0918802
Sex: U
Age:
State: MD

Vax Date: 12/01/2020
Onset Date: 12/01/2020
Rec V Date: 01/04/2021
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: Bells Palsy; This is a spontaneous report from a contactable consumer or other non HCP. This consumer reported same events for three patients. This is a 3rd of 3 reports. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, also reported as Comirnaty), via an unspecified route of administration on an unspecified in Dec2020 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Healthcare worker reported that 3 nurses who work in her facility received Pfizer's COVID vaccine last week (Dec2020) came in with Bells Palsy. Event took place after use of product. The outcome of event was unknown. No follow-up attempts are possible; information about batch/lot number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020519118 same reporter, same drug, same event, different patients;US-PFIZER INC-2020519105 same reporter, same drug, same event, different patients

Other Meds:

Current Illness:

ID: 0918803
Sex: F
Age:
State: FL

Vax Date: 12/08/2020
Onset Date: 12/08/2020
Rec V Date: 01/04/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Headache, Limb discomfort, Nasal congestion

Symptoms: a 20 month old, inadvertently, received a Quadracel vaccine instead of the DTaP with no AE; a 20 month old, inadvertently, received a Quadracel vaccine with no AE; Initial information regarding an unsolicited valid non-serious case was received from a nurse via Medical Information (Reference number- 00385237) and transmitted to Sanofi on 08-Dec-2020. This case involves a 20 months old female patient who was inadvertently administered a 0.5ml standard dose of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] (lot number: C5763AA and expiry date: 26-Aug-2022) once via intramuscular route in the right thigh for prophylactic vaccination (Product administered to patient of inappropriate age) instead of fourth dose of DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE produced by unknown manufacturer (wrong product administered) on 08-Dec-2020. The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included INFLUENZA VACCINE INACT SPLIT 4V (FLUZONE QUADRIVALENT) and HIB VACCINE CONJ (TET TOX) (ACTHIB) for prophylactic vaccination. This was an actual medication error due to wrong vaccine administered and inappropriate age at vaccine administration (latency was same day). At the time of reporting, no adverse event was reported to the patient. Reporter asked if this dose would count in vaccination and if there were any concerns. Reporter stated that the physician did not think so and the office just wanted to know. Reporter also stated that this vaccine was used for first time in the patient. No potential product technical complaint (PTC). This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.

Other Meds: FLUZONE QUADRIVALENT; ACTHIB

Current Illness:

ID: 0918804
Sex: M
Age: 70
State: AR

Vax Date: 12/17/2020
Onset Date: 12/23/2020
Rec V Date: 01/04/2021
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: Back pain, Cold sweat, Headache, Nausea, Vomiting

Symptoms: This report is only in response to the request from the agency to submit all patients into VAERS that received the COVID19 vaccine and subsequently tested positive for COVID19. No other adverse reactions to the vaccine were reported. The patient reported a COVID19 positive test on 12/23/20.

Other Meds:

Current Illness:

ID: 0918806
Sex: F
Age: 39
State: OH

Vax Date: 12/27/2020
Onset Date: 01/03/2021
Rec V Date: 01/04/2021
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: none

Symptom List: Injection site swelling, Limb discomfort

Symptoms: On Day 8 of vaccination (1/3/21) woke up with a sore arm, swelling and hard area. Slight pink area and warm to the touch. Mild itching occurred evening of 1/3/21. Cold compress applied, not helpful. On day 9 (1/4/21) all symptoms continue but increase of pain and heavy feeling in arm. Swelling is increased, pink area is increased. Remains warm to touch.

Other Meds: Sertraline, melatonin, Vit B-6, L-theanine drink daily nutrition shake for meal replacement

Current Illness: none

ID: 0918807
Sex: M
Age: 49
State: AK

Vax Date: 12/31/2020
Onset Date: 01/02/2021
Rec V Date: 01/04/2021
Hospital:

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

Lab Data:

Allergies: Latex allergy

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

Symptoms: Patient got his Covid vaccine this past Thursday, 2 days ago. He experienced typical side effects of a sore left shoulder and some fatigue but was feeling well until this afternoon around 1:55 PM when he noticed throbbing of his left hand. He looked down and noticed that there was a purple discoloration to his middle finger and distal palmar aspect of his hand. He felt like there was maybe some swelling as well and that he might have been having an allergic reaction so called the emergency department for further advice and came in for evaluation. By the time I arrived to the emergency department the patient's left hand was no longer swollen and there was only a small purple discoloration to the palmar proximal middle finger. I was concerned that the patient developed a small blood clot that was resolved upon evaluation.

Other Meds: None

Current Illness: None

ID: 0918808
Sex: F
Age: 37
State: NY

Vax Date: 01/02/2021
Onset Date: 01/02/2021
Rec V Date: 01/04/2021
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: Fever of 101.5 and Heart palpatations

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 636,615

Page last modified: 03 October 2021 5:28pm