VAERS 2021 Database www.vaers.hhs.gov

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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: 1261546
Sex: M
Age: 65
State: MS

Vax Date: 02/25/2021
Onset Date:
Rec V Date: 04/27/2021
Hospital: Y

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: hospitalized; unable to take his second vaccine within the recommended window; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of HOSPITALISATION (hospitalized) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HOSPITALISATION (hospitalized) (seriousness criterion hospitalization) and PRODUCT DOSE OMISSION ISSUE (unable to take his second vaccine within the recommended window). At the time of the report, HOSPITALISATION (hospitalized) and PRODUCT DOSE OMISSION ISSUE (unable to take his second vaccine within the recommended window) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. This case of a 65-year-old male patient who was hospitalized (reason not provided) and was unable to take his second vaccine within the recommended window(product dose omission). There is not enough information to assess the event of hospitalization as reason for hospitalization was not provided. The event of product dose omission is assessed as not applicable.; Sender's Comments: This case of a 65-year-old male patient who was hospitalized (reason not provided) and was unable to take his second vaccine within the recommended window(product dose omission). There is not enough information to assess the event of hospitalization as reason for hospitalization was not provided. The event of product dose omission is assessed as not applicable.

Other Meds:

Current Illness:

ID: 1261547
Sex: F
Age:
State: IL

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

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: Mass on Kidney; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of RENAL MASS (Mass on Kidney) in a 77-year-old female patient who received mRNA-1273 for COVID-19 vaccination. The patient's past medical history included Thyrotoxicosis with goiter (Thyrotoxicosis with diffuse goiter without thyrotoxic crisis). Concurrent medical conditions included Sulfonamide allergy (Allergic to sulfa antibiotics) and Chronic lymphocytic leukemia (Chronic Lymphocytic Leukemia of B cell type not having achieved remission). Concomitant products included IBRUTINIB (IMBRUVICA) from 10-Dec-2016 to 23-May-2018 for Chronic lymphocytic leukemia, PARACETAMOL (TYLENOL), METHIMAZOLE, VITAMIN D NOS, ATORVASTATIN CALCIUM, GABAPENTIN, LIDOCAINE, METOPROLOL TARTRATE, OXYCODONE HYDROCHLORIDE, CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) and VITAMIN C [ASCORBIC ACID] for an unknown indication. On an unknown date, the patient received first dose of mRNA-1273 (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RENAL MASS (Mass on Kidney) (seriousness criteria hospitalization). At the time of the report, RENAL MASS (Mass on Kidney) outcome was unknown. For mRNA-1273 (Intramuscular), the reporter did not provide any causality assessments. The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the mRNA-1273 in response to the events was not applicable. Based on current available information and the temporal Association between product use and the start date of the events a causal relationship is unlikely. Very little information is available for review. Further information has been requested.; Sender's Comments: Based on current available information and the temporal Association between product use and the start date of the events a causal relationship is unlikely. Very little information is available for review. Further information has been requested.

Other Meds: IMBRUVICA; TYLENOL; METHIMAZOLE; VITAMIN D NOS; ATORVASTATIN CALCIUM; GABAPENTIN; LIDOCAINE; METOPROLOL TARTRATE; OXYCODONE HYDROCHLORIDE; ZYRTEC [CETIRIZINE HYDROCHLORIDE]; BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]; VITAMIN C [ASCORBIC ACID

Current Illness: Chronic lymphocytic leukemia (Chronic Lymphocytic Leukemia of B cell type not having achieved remission); Sulfonamide allergy (Allergic to sulpha antibiotics)

ID: 1261548
Sex: F
Age: 57
State: NY

Vax Date: 03/08/2021
Onset Date: 03/26/2021
Rec V Date: 04/27/2021
Hospital: Y

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: COVID pneumonia, Covid 19 positive, acute respiratory failure, hypoxia; Encephalopathy; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 PNEUMONIA (COVID pneumonia, Covid 19 positive, acute respiratory failure, hypoxia) and ENCEPHALOPATHY (Encephalopathy) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Chronic migraine, Fibromyalgia, DVT, Pulmonary embolism, Clotting disorder, Bipolar disorder, Immunodeficiency, Chronic obstructive pulmonary disease, Congestive heart failure, Hypertension, Arthritis, Drug allergy (Allergy to cephalosporins, NSAIDS, Quinolones, Darvocet, trazodone, lyrica), Peanut allergy (Allergy to peanut, tree nut) and Latex allergy. Concomitant products included ALBUTEROL [SALBUTAMOL], AMLODIPINE, BUSPIRONE, CILOSTAZOL and CYCLOBENZAPRINE for an unknown indication. On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced COVID-19 PNEUMONIA (COVID pneumonia, Covid 19 positive, acute respiratory failure, hypoxia) (seriousness criteria hospitalization and medically significant) and ENCEPHALOPATHY (Encephalopathy) (seriousness criteria hospitalization and medically significant). The patient was hospitalized on 28-Mar-2021 due to COVID-19 PNEUMONIA and ENCEPHALOPATHY. At the time of the report, COVID-19 PNEUMONIA (COVID pneumonia, Covid 19 positive, acute respiratory failure, hypoxia) and ENCEPHALOPATHY (Encephalopathy) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Chest X-ray: Multifocal pneumonia. In March 2021, Computerised tomogram: CT head showed Punctate hyper density in the right hemipons without direct correlation on previous imaging. In March 2021, SARS-CoV-2 test: positive (Positive) positive. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No Treatment medications were provided. Based on the current available information and temporal association between the use of the product and the start date of the event, COVID19 pneumonia a causal relationship may be unlikely related. Encephalopathy may ensue with the widespread infection stemming from COVID19.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, COVID19 pneumonia a causal relationship may be unlikely related. Encephalopathy may ensue with the widespread infection stemming from COVID19.

Other Meds: ALBUTEROL [SALBUTAMOL]; AMLODIPINE; BUSPIRONE; CILOSTAZOL; CYCLOBENZAPRINE

Current Illness: Arthritis; Bipolar disorder; Chronic migraine; Chronic obstructive pulmonary disease; Clotting disorder; Congestive heart failure; Drug allergy (Allergy to cephalosporins, NSAIDS, Quinolones, Darvocet, trazodone, lyrica); DVT; Hypertension; Immunodeficiency; Latex allergy; Peanut allergy (Allergy to peanut, tree nut); Pulmonary embolism

ID: 1261549
Sex: M
Age:
State:

Vax Date: 04/17/2021
Onset Date:
Rec V Date: 04/27/2021
Hospital: Y

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 diarrhea; tachycardia; chest pain; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DIARRHOEA (severe diarrhea), TACHYCARDIA (tachycardia) and CHEST PAIN (chest pain) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination. No Medical History information was reported. On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (severe diarrhea) (seriousness criterion hospitalization), TACHYCARDIA (tachycardia) (seriousness criterion hospitalization prolonged) and CHEST PAIN (chest pain) (seriousness criterion hospitalization). The patient was hospitalized on 28-Mar-2021 due to DIARRHOEA. At the time of the report, DIARRHOEA (severe diarrhea) was resolving, TACHYCARDIA (tachycardia) had not resolved and CHEST PAIN (chest pain) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, SARS-CoV-2 antibody test: positive (Positive) Had no symptoms from Covid 19. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were provided to the patient. Treatment information was not provided. Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded. Onset date for events was provided as 28-Apr-2021, which is after the report was submitted. As vaccine was administered on 17-apr-2021 it is likely the onset date of events was 18-apr-2021 rather than the 28th, but this will need to be clarified on FU; Sender's Comments: Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded. Onset date for events was provided as 28-Apr-2021, which is after the report was submitted. As vaccine was administered on 17-apr-2021 it is likely the onset date of events was 18-apr-2021 rather than the 28th, but this will need to be clarified on FU.

Other Meds:

Current Illness:

ID: 1261550
Sex: M
Age:
State: FL

Vax Date: 01/25/2021
Onset Date: 01/25/2021
Rec V Date: 04/27/2021
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: Pain in the arm w/vaccine; chills; lightheaded; severe cough with lots of phlegm; lowgrade fever; sluggish; very tired; This is a spontaneous report from a contactable consumer (patient). A 73-year-old male patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Lot number: EL1283, Expiration date was not reported), via an unspecified route of administration, on 25Jan2021 10:00 right arm as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. patient did not receive any other medications within 2 weeks of vaccination. Allergies to medications, food, or other products reported as no. Prior to vaccination, the patient diagnosed with COVID-19 reported as unknown. Since the vaccination, patient has not been tested for COVID-19. Patient experienced Pain in the arm w/vaccine, chills and lightheaded on 25Jan2021 12:00. Next few days had a severe cough with lots of phlegm low-grade fever, sluggish, very tired on an unspecified date in 2021. My wife called our Primary and he gave me prescribed cough medicine and antibiotics which I am drinking now. Ironically my wife did not get the vaccine but tested positive for covid on 03Feb. She got very ill on 31Jan. As per the reporter seriousness criteria for the events reported as non-serious. The outcome of the events was unknown.

Other Meds:

Current Illness:

ID: 1261551
Sex: M
Age:
State: NC

Vax Date: 01/27/2021
Onset Date: 01/27/2021
Rec V Date: 04/27/2021
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: Fever; Congestion, head congestion, chest congestion; Congestion, head congestion, chest congestion; Cough; Stiff neck, it is in upper shoulder, it is real tight; Forearm ache; Sluggish and tired; Sluggish and tired; This is a spontaneous report from a contactable consumer (patient). A 72-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EL3247) via an unspecified route of administration in right arm on 27Jan2021 09:00 as single dose for covid-19 immunization. The patient was 72-years-old at the time of vaccination. The vaccination facility type was hospital. No prior Vaccinations within 4 weeks.The patients medical history included diabetes mellitus, blood pressure abnormal, blood cholesterol abnormal, thyroid disorder, cardiac disorder, neuropathy peripheral, anxiety from an unknown date and unknown if ongoing. The patient's concomitant medication(s) included atorvastatin strength 80 mg and at a dose of 80 mg once a day at night time, taken for blood cholesterol, levothyroxine sodium (SYNTHROID), strength 50 mg and at a dose of 50 mg once a day in the morning, taken for thyroid disorder; bisoprolol, strength 5 mg and at a dose of 5mg half a tablet once a day, taken for blood pressure abnormal and cardiac disorder; hydrochlorothiazide, strength 25 mg and at a dose of 25mg once a day, taken for blood pressure abnormal; gabapentin, strength 300 mg and at a dose of 300mg capsule; up to three times a day as needed, taken for neuropathy peripheral, venlafaxine hydrochloride strength 75 mg at a dose of 75mg one capsule once a day, taken for anxiety; aspirin [acetylsalicylic acid] at a dose of 81mg at night, taken for an unspecified indication. The concomitant medications started from an unknown date and were ongoing. The patient experienced sluggish and tired on 27Jan2021, forearm ache on 27Jan2021, fever on 28Jan2021, , congestion, head congestion, chest congestion on 28Jan2021, cough on 28Jan2021, stiff neck, it is in upper shoulder, it is real tight on 28Jan2021. The outcome of the events sluggish and tired, fever, congestion, head congestion, chest congestion were recovering and unknown for the other events. He is scheduled for the second vaccine on 18Feb2021. He wants to know if that is still recommended? Follow-up attempts are completed. No further information is expected.

Other Meds: ATORVASTATIN; SYNTHROID; BISOPROLOL; HYDROCHLOROTHIAZIDE; GABAPENTIN; VENLAFAXINE HCL; ASPIRIN [ACETYLSALICYLIC ACID]

Current Illness:

ID: 1261552
Sex: F
Age:
State: GA

Vax Date:
Onset Date:
Rec V Date: 04/27/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Pyrexia, White blood cell count decreased

Symptoms: felt something popped in her hip/knee area when she stepped upstairs; chills; This is a spontaneous report from a sponsored program. A contactable female consumer (patient) reported that A female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown, Expiration date: unknown), via an unspecified route of administration on an unspecified date at single dose and second dose received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown, expiration date: unknown), via an unspecified route of administration on 13Feb2021 12:30 PM at single dose for COVID-19 immunization. The patient medical history and concomitant medication were not reported. Patient experienced after first dose felt something popped in her hip/knee area when stepped upstairs, and patient was taking meloxicam every day. Patient felt something cool in chest, it was like water whooshing through body. It occurred for about 5-6 minutes and patient went to the emergency room to have it checked and the HCPs said that patient was having chills. The outcome of event felt something popped in her hip/knee was unknown and other outcome of event chill was recovered. Follow-up (13Feb2021): This is a follow-up spontaneous report from a sponsored program. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1261553
Sex: F
Age:
State: CA

Vax Date: 02/02/2021
Onset Date: 02/02/2021
Rec V Date: 04/27/2021
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: Sore jaw - painful "clicking"/Jaw pain; Sore jaw - painful "clicking"/Jaw pain; This is a spontaneous report from a contactable consumer. A 69-years-old female patient (Non-pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EN5318) intramuscular, administered in left arm on 02Feb2021 17:00 at a single dose for COVID-19 immunization. Medical history included ongoing autoimmune Hashimoto's disease, known allergies to sulfa, osteoporosis and she had 2 oral surgeries. Concomitant medication included levothyroxine sodium (LEVOXYL) and probiotics. On 02Feb2021 18:00 The patient experienced sore jaw - painful "clicking"/jaw pain. No covid prior vaccination and No tested covid post vaccination. The caller said that she started taking Fosamax for osteoporosis. She stated for the first 4 doses it caused her joint pain and on the 4th week she got jaw pain. Patient took it once a week. Patient was advised to stop taking it and she did. The caller said that she has had the clicking in her jaw since taking Fosamax and this has been ongoing. She is not a medication taker. She said that she did take Advil for the jaw pain and then she read the next day that you should not take it before or after the Covid vaccine. The caller said that all of the other information that she read said that it was ok to take it after the vaccine, just not before. Her second dose was scheduled for 23Feb2021. Treatment was given for the events. The outcome of the events was recovered on 07Feb2021.

Other Meds: LEVOXYL; PROBIOTICS

Current Illness: Hashimoto's disease (Verbatim: Hashimoto's disease;Additional Information for Other Conditions: She said that she takes medication for it. She said that she was diagnosed 14 years ago.)

ID: 1261554
Sex: M
Age:
State: KY

Vax Date: 01/24/2021
Onset Date: 01/25/2021
Rec V Date: 04/27/2021
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: Light headed; This is a spontaneous report from a contactable consumer (patient). A 87-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and expiry: not reported), via an unspecified route of administration, administered in arm left on 24Jan2021 13:30 as single dose for covid-19 immunisation (at the age of 87 years). Medical history included macular degeneration, neuropathy and no known allergies. Concomitant medications included metformin, gabapentin and statins. There was no covid prior vaccination and no covid prior vaccination and no other vaccine in four weeks. On 25Jan2021 14:00, the patient experienced light headed. The outcome of event was recovered on an unspecified date in 2021. Information of Lot/Batch number has been requested.

Other Meds: METFORMIN; GABAPENTIN

Current Illness:

ID: 1261555
Sex: F
Age:
State: CO

Vax Date: 02/12/2021
Onset Date: 02/12/2021
Rec V Date: 04/27/2021
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: body aches; diuresis; shortness of breath with pO2 = 84; chills (used every blanket that I could find; tremendous thirst; vomiting; This is a spontaneous report from a contactable consumer (patient). A 74-year-old non pregnant female patient second dose received bnt162b2 (BNT162B2, solution for injection, single dose; age at time of vaccination 74-year), via an unspecified route of administration in left arm on 12Feb2021 13:15 as single dose for covid-19. Medical history included Multiple connective tissue disorder; COVID-19. The patient concomitant medication included prednisone (unknown formulation) from 29Jan2021 at 10 mg, daily. The patient previously received first single dose of bnt162b2 on 22Jan2021 single dose for Covid-19 immunization (age at time of vaccination 74-year). Also had Sulfa drugs allergy. the patient receive other vaccines within 4 weeks prior to the COVID vaccine; other medications the patient received within 2 weeks of vaccination was Prednisone 10mg/day. On 12Feb2021 23:00, chills (used every blanket that I could find), tremendous thirst, vomiting. In the morning and next day (13Feb2021) body aches and diuresis. Next night (13FEB2021) shortness of breath with p02 84. By morning of (14Feb2021) shortness of breath was gone and p02 back to 96. Vomiting and aches continued for part of the day. Patient not received treatment for the adverse event. The reported seriousness for all events was non serious. Prior to vaccination, the patient diagnosed with COVID-19; Since the vaccination, the patient not tested for COVID-19. The outcome of the events chills, tremendous thirst, vomiting, body aches and diuresis was reported as recovering and the patient recovered from the event shortness of breath on 14Feb2021. Information on the lot/batch number has been requested.

Other Meds: PREDNISONE

Current Illness:

ID: 1261556
Sex: M
Age:
State: MI

Vax Date: 02/12/2021
Onset Date: 02/14/2021
Rec V Date: 04/27/2021
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: Headache; fatigue; body aches; cold-like symptoms; This is a spontaneous report from a contactable consumer. A 34-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EL3248) via an unspecified route of administration in right arm on 12Feb2021 15:00 as single dose and was previously administered the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EL3248) via an unspecified route of administration in right arm on 19Jan2021 07:30 for covid-19 immunization. Patient was 34-years-old at the time of vaccination. Vaccination facility type was workplace clinic. Patient medical history was not reported. Concomitant medication included fish oil, alprazolam and vitamins nos (DAILY MULTIVITAMIN). On 14Feb2021 at 09:00, the patient experienced headache, fatigue, body aches and cold-like symptoms. No covid prior vaccination. No covid tested post vaccination. No known allergies. No other vaccine in four weeks. No treatment was given for the event. The outcome of the events was recovering.

Other Meds: FISH OIL; ALPRAZOLAM; DAILY MULTIVITAMIN

Current Illness:

ID: 1261557
Sex: F
Age:
State: OH

Vax Date: 01/28/2021
Onset Date: 01/28/2021
Rec V Date: 04/27/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Rash, Urticaria

Symptoms: eczema; had rash and itching on the front of her chest and stomach area and spreaded all over the front and then went to the back; had rash and itching on the front of her chest and stomach area and spreaded all over the front and then went to the back; This is a spontaneous report received from a contactable health care professional (patient). A 76-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL9265, Expiry date: Unknown) on 28Jan2021 at 11:40 (at the age of 76-years-old) via unknown route at single dose on high on left upper arm for COVID-19 immunization. Relevant medical history included cold sores in nose and mouth. The patient was allergic to morphine and the morphine family drug. She had reaction when she had her hysterectomy (Occurred just one time and was years ago). The patient takes one prescription for her thyroid. The patient also had a medical history of Herpes and shingles. On the same date 28Jan2021, after 4 to 6 hours of vaccination (at 16:00 to 17:00) the patient had rash and itching on the front of her chest and stomach area and spreaded all over the front and then went to the back. The patient did not have rash on arms and legs, only on torso. She had no trouble in breathing and swelling. The patient also had eczema immediately after the COVID-19 Vaccination and she does not know her stress might have triggered it.The patient wants to know whether she should receive the second dose and if the second dose would cause a worse reaction than the first time. The patient prescribing physician told it did not sound like anything serious, just a mild reaction. A week later the patient went to dermatologist. Both her doctor and dermatologist stated it does not sound like it was severe. The patient's dermatologist stated it was a mild reaction rash and itching and told her it was fine to receive the second dose. The patient to get a steroid cream to get rid of the itch and rash. The patient was anxiety and stuff from not living normally. The patient worked in a retirement and nursing home for a very short time, but was never a physician, pharmacist, or nurse. She received treatment with triamcinolone ointment 0.1 percent. The action taken in response to the event(s) for BNT162B2 was not applicable. Outcome of the events ?had rash and itching on the front of her chest and stomach area and spreaded all over the front and then went to the back' and eczema was unknown.

Other Meds:

Current Illness:

ID: 1261558
Sex: F
Age:
State: FL

Vax Date:
Onset Date:
Rec V Date: 04/27/2021
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: terrible headaches; fever; nausea; terrible stomach pain; colitis; fatigue; diarrhea; she was sick; This is a spontaneous report from a contactable consumer or other non hcp. A 66-years-old female patient received bnt162b2 (BNT162B2, Solution for injection), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot Number: EN5318) as SINGLE DOSE for covid-19 immunisation. Medical history included sore arm as a side effect when she had a pneumonia shot. The patient's concomitant medications were not reported. Historical vaccine included bnt162b2 (BNT162B2, Solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot Number: EL1283) as SINGLE DOSE for covid-19 immunisation and had a sore arm for 2 days and joint pain for over a week.On an unspecified date after 2 dose of vaccine, patient experienced terrible headaches, fever, nausea, terrible stomach pain, fatigue, diarrhoea, colitis which she had never had before and she was sick. It was reported that at the end of the week patient started feeling better, however she started with diarrhea again and its been for over a week. If she eats anything she had to go right to the bathroom (banana, rice, turkey, eggs (8 pounds to begin), she was trying to hydrate herself. She started eating lightly trying to heal, and after a week she thought she was better, now her stomach was a wreck. Patient wanted to know the duration of these symptoms and if vaccine could have been contaminated and if she was going to have this gastric symptom for a long time or the whole time.She would like to know how the vaccine works and how does it leave your system. She says that the minute she got home she had the runs, it went right through her. She says she started eating lightly trying to heal, and after a week she thought she was better, now her stomach was a wreck. She says she had done a report before. Caller says that she would like to report that and ask question, since the vaccine was in her, would this always be a problem, it feels like she had colitis which she has never had before. She said she could not get to her doctor for an appointment for a few days, and she would like to know if it could be her IBS. She said with a normal medication she could drink a lot to get it out of her system, but with a vaccine she was not sure of what she could do. She says after the second time she did an online report and then she was starting to feel much better then her stomach exploded again. Caller says she can't eat much, and she was wondering how the vaccine works, since it was still in her and irritating her. The outcome of the event's terrible headaches, fever, nausea, terrible stomach pain, fatigue, colitis and she was sick were reported as unknow and the outcome of diarrhoea was not recovered. Information on batch number has been requested.

Other Meds:

Current Illness:

ID: 1261559
Sex: F
Age:
State: VA

Vax Date: 02/10/2021
Onset Date: 02/11/2021
Rec V Date: 04/27/2021
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: dry mouth; swelling redness at injection site; swelling redness at injection site; tired; chills; wasn't feeling herself; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE,Lot Number: EN5318; Expiry date: Unknown), dose 2 via an unspecified route of administration, administered in Arm Left on 10Feb2021 at SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 11Feb2021, the patient experienced tired and chills, after 3 days on 13Feb2021, dry mouth, swelling redness at injection site and swelling redness at injection site and wasn't feeling herself. The patient stated that after receiving the vaccine she was fine and went to sleep that day, it was the next day on 11Feb2021 is when she experienced the chills and being tired. She didn't go out, she wasn't feeling herself. The injection site was noticed around the 3rd day, she had a band aid on it, she was instructed to keep the band aid on for a couple days, she noticed the injection site symptoms around the 13Feb2021. She is calling because she wants to know if she can take any kind of medicine like aspirin. She hasn't gotten out of bed, she is tired. She is still experiencing all the symptoms reported. The outcome of the event was not recovered.

Other Meds:

Current Illness:

ID: 1261560
Sex: M
Age:
State: MA

Vax Date: 02/16/2021
Onset Date: 02/17/2021
Rec V Date: 04/27/2021
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: low fever (100F); headache; muscle ache; This is a spontaneous report from a contactable consumer. A 64-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration on 16Feb2021 09:00 as single dose for covid-19 immunization. Patient was 64-years-old at the time of vaccination. Vaccination facility type was workplace clinic. The patient medical history and concomitant medications were not reported. No Known allergies. On 26Jan2021, the patient received other pfizer vaccine within 4 weeks. No other medications in two weeks. No prior covid vaccination. No covid tested post vaccination. On 17Feb2021 at 01:00, patient experienced Low fever (100F), headache, muscle ache. The events assessed as non-serious. No treatment received. The outcome of the events was unknown. Information about lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1261561
Sex: F
Age:
State: MA

Vax Date: 01/22/2021
Onset Date: 01/22/2021
Rec V Date: 04/27/2021
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: covid_test_name_post_vaccination= RT-PCR, covid_test_date= 29Jan2021, covid_test_result= Positive; Itching soft palate area; Itching in ears; mild respiratory trouble; This is a spontaneous report received from a contactable health care professional (patient) and from a Pfizer sponsored program. A 44-year-old female patient of received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL9261) left arm on 22Jan2021 at 17:45 (at the age of 40-years-old) via intramuscularly at single dose on the unspecified anatomical location for COVID-19 immunization. Relevant medical history included asthma and psoriasis. The patient had known allergy to penicillin. The patient did not receive any other vaccine in four weeks. The patient was not pregnant at the time of vaccination. Concomitant medications included fluticasone propionate (FLOVENT), ethinylestradiol,/levonorgestrel (SRONYX) and cetirizine. On the same date, two hours (at 19:00) after administration of first dose the patient had Itching soft palate area, itching in ears and mild respiratory trouble. The patient received treatment with diphenhydramine 25mg. On 29Jan2021, nasal swab RT-PCR COVID test was positive for the patient. Outcome of the events Itching soft palate area, itching in ears and mild respiratory trouble was recovered while outcome of the event was unknown. The action taken in response to the event(s) for BNT162B2 was not applicable.

Other Meds: FLOVENT; SRONYX; CETIRIZINE

Current Illness:

ID: 1261562
Sex: F
Age:
State: MN

Vax Date: 02/08/2021
Onset Date: 02/08/2021
Rec V Date: 04/27/2021
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: She is tired; she has been sneezing; injection site is extremely painful; Chills; mild headache; muscle and joint pain; muscle and joint pain; temperature went up to 98.8; Cold; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 86-years-old female patient received first dose of bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot Number: EN5138, Expire Date: Unknown) intramuscularly in arm left on 08Feb2021 at 09:20 as single dose for COVID-19 immunization. Medical history included ongoing diabetes, thyroid disorder. She was diagnosed for diabetes for about 30 years ago. Concomitant medications included unspecified thyroid pill, furosemide (LASIX [FUROSEMIDE]) taken for an unspecified indication and ongoing metformin (METFORMIN) 500mg tablet by mouth three times a day taken for diabetes. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. On 08Feb2021, the patient stated the injection site was extremely painful. She had not put on a cold pack. She had the chills so bad. She was letting it hurt. She was tired. She had a mild headache and still has one, its not bad. She had muscle and joint pain. She had a slight fever. She came down with a cold on the same day she had the vaccine, she had been sneezing and had the whole thing with a cold. She does not think the cold had anything to do with the shot. The patient underwent lab tests and procedures which included body temperature fluctuation: 98.8 on 08Feb2021. Her normal temperature is 96.2, and her temperature went up to 98.8, her temp is starting to go down. She was scheduled for second dose on 01Mar2021. The outcome of the events injection site is extremely painful, muscle and joint pain, temperature went up to 98.8 were reported as recovering/resolving and other events chills, cold was reported as not recovered/not resolved and mild headache was reported as recovered/resolved on Feb2021. The outcome events sneezing and fatigue were unknown.

Other Meds: LASIX [FUROSEMIDE]; METFORMIN

Current Illness: Diabetes

ID: 1261563
Sex: F
Age:
State:

Vax Date: 02/10/2021
Onset Date: 02/10/2021
Rec V Date: 04/27/2021
Hospital:

Vax Type: HIBV
Manufacturer: MERCK & CO. INC.
Vax Name: HIB (PEDVAXHIB)
Lot:
Dose Series: UNK
Vax Route:
Vax Site: LG

Lab Data:

Allergies:

Symptom List: Ear pain, Hypoaesthesia

Symptoms: jaw tenderness; soreness on her arm; This is a spontaneous report from a contactable nurse. This female nurse (patient) reported that she received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 Vaccine; Solution for injection; Lot number/Expiry date: Unknown) via an unspecified route of administration as a single dose for COVID-19 immunization on 10Feb2021. The patient's medical history and concomitant medications were not reported. On 10Feb2021, she had only soreness on her arm where she got the vaccine and on 11Feb2021 (reported as now this morning), she is having jaw tenderness when she opens her mouth. She says she would like to know if this is a known side effect or something else. She says that it is slight, so it could be something else. Investigation Assessment was Not Provided. The clinical outcome for the events was unknown. No follow-up attempts are possible. No further information is expected. Information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1261564
Sex: M
Age:
State: MI

Vax Date: 01/22/2021
Onset Date: 01/22/2021
Rec V Date: 04/27/2021
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: After second vaccination, an intermittent "squeezing" full head headache (each lasting around 2-3 seconds) starting; This is a spontaneous report from a contactable pharmacist. The 46-year-old male patient received bnt162b2 (COMIRNATY) solution for injection, dose 2 (Batch/Lot Number: EL3249) on 22Jan2021, at 09:30 AM, and dose 1 (Batch/Lot Number: EK9231) on 02Jan2021 at 10:00 AM via an Intramuscular route of administration in right arm as a single dose for covid-19 immunisation. The medical history and concomitant medication were not reported. Patient reported on 22Jan2021 at 01:15 PM after 1st vaccination, mild intermittent headache that subsided after 24 hours. And after second vaccination, a intermittent squeezing full head headache (each lasting around 2-3 seconds) starting 2 hours post vaccination. It seemed to subside after 2 weeks and now has returned. Patient took other medications in two weeks once time. Patient received treatment drug as Ibuprofen. The patient did not have covid prior vaccination. The patient was not tested for covid post vaccination. Patient did not have any known allergies. The outcome of event was Not recovered.

Other Meds: IBUPROFEN

Current Illness:

ID: 1261565
Sex: M
Age:
State: OH

Vax Date: 02/13/2021
Onset Date: 02/13/2021
Rec V Date: 04/27/2021
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: fever/My dad reached up to a 103; My dad was sleepy and tired after he got the shot yesterday in the morning; My dad was sleepy and tired after he got the shot yesterday in the morning; This is a spontaneous report from a contactable consumer via Medical information team. An 83-year-old male patient received second dose of bnt162b2 (BNT162B2, Solution for injection, Lot number and Expiration date was not reported), via an unspecified route of administration on 13Feb2021 as single dose for covid-19 immunisation. Medical history included high blood pressure. Concomitant medication was not reported. Historical vaccine included first dose of BNT162B2 for Covid-19 immunization. reporter (daughter) stated, "I am calling for my mom and dad, both of them received the second Pfizer shot yesterday and they both have the same age, they both (birth year withheld) born. They both had fever just last night like this early morning. My dad reached up to a 103. My dad was sleepy and tired after he got the shot yesterday in the morning. He was sleepy and then in the evening he starts getting fever on 13Feb2021. They took tylenol for it. The patient underwent lab tests and procedures which included height: 5'5, 5'3 as well, temperatures: 103 and Weight: about 200 lbs on an unspecified date in 2021. The outcome of the events was unknown. Information on Lot /Batch Number has been requested.

Other Meds:

Current Illness:

ID: 1261566
Sex: M
Age:
State: MA

Vax Date: 02/14/2021
Onset Date: 02/14/2021
Rec V Date: 04/27/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot: Eh9899
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site erythema, Injection site pruritus, Injection site swelling, Lymph node pain, Lymphadenopathy

Symptoms: Swelling in left armpit lymph node.Swelling and water retention in surrounding area; 1st dose administered on 28Jan2021 and 2nd dose administered on 14Feb2021; This is a spontaneous report from a contactable consumer (patient). A 42-years-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL9264, expiry date was unknown) via an unknown route in the left arm on 14Feb2021, at 07:45 AM, (at the age of 42 years) as a single dose for COVID-19 immunisation. Patient did not have medical history. The patient had no allergies. Concomitant medications included curcuma longa rhizome, piper nigrum fruit (TURMERIC) and chondroitin (within 2 weeks of the vaccination). Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL9262, expiry date was unknown) via an unknown route in the left arm on 28Jan2021 at 05:00 PM (at the age of 41 years) as a single dose for COVID-19 immunization. On 02Feb2021, the patient had covid test (covid test type post vaccination: Nasal Swab) and result was negative. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 15Feb2021 at 04:00 AM the patient experienced swelling in left armpit lymph node, swelling and water retention in surrounding area. Patient did not receive any treatment for the adverse event. 1st dose administered on 28Jan2021 and 2nd dose administered on 14Feb2021 to patient, which is Inappropriate schedule of vaccine administered. The outcome of the event swelling in left armpit lymph node, swelling and water retention in surrounding area was recovering. Information about batch number has been requested.

Other Meds: CHONDROITIN; TURMERIC +

Current Illness:

ID: 1261567
Sex: F
Age:
State: FL

Vax Date: 02/03/2021
Onset Date: 02/03/2021
Rec V Date: 04/27/2021
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: chills; Fever/fever 99.9; Malaise; Headache; This is a spontaneous report from a contactable consumer, the patient. A 72-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 03Feb2021 (Batch/Lot Number: EL8952) (at the age of 72-years-old) as single dose for covid-19 immunisation. The patient medical history was not reported. Concomitant medications included azilsartan kamedoxomil (EDARBI) and torsemide (MANUFACTURER UNKNOWN) both taken for an unspecified indication from an unspecified start date and ongoing. The patient previously received BNT162B2 (COMIRNATY), dose 1, administered in Arm left (Batch/Lot number: EK9231) (at the age of 72-years-old) for covid-19 immunisation and experienced malaise, nausea, no appetite and throwing up bile. On 03Feb2021, the patient experienced chills, fever, malaise, headache. The events not resulted in emergency room/physician office. The outcome of events was unknown.

Other Meds: EDARBI; TORSEMIDE

Current Illness:

ID: 1261568
Sex: M
Age:
State: MO

Vax Date: 02/16/2021
Onset Date: 02/16/2021
Rec V Date: 04/27/2021
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: headache; sore muscles throughout my body; alternating sense of hot/cold; general fatigue; strong soreness at the injection site (left arm); feeling chills; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm left on 16Feb2021 09:00 (Batch/Lot Number: EN 5318) (at the age of 39-years-old) as single dose for covid-19 immunisation. Medical history included none. The patient had no known allergies. Concomitant medication included desvenlafaxine succinate (PRISTIQ) 50 mg ER taken for an unspecified indication, from an unknown start date (two weeks prior to vaccination). The patient previously received BNT162B2 (Batch/Lot Number: EN 5318) dose 1 via an unspecified route of administration in left arm on 26Jan2021 at 12:00 for covid-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On the day when patient received second dose on 16Feb2021 at 21:00, he felt strong soreness at the injection site (left arm) and began feeling chills by the time he went to bed (12 hours after receiving the vaccine), but no other symptoms. On the following day (17Feb2021) when he woke up, he experienced a multitude of symptoms, including headache, sore muscles throughout my body, alternating sense of hot/cold, and general fatigue. These symptoms continued most of the day but began to subside by that evening. No treatment was given for the events. The outcome of the events was recovered on 18Feb2021.

Other Meds: PRISTIQ

Current Illness:

ID: 1261569
Sex: F
Age:
State: NY

Vax Date: 02/15/2021
Onset Date: 02/20/2021
Rec V Date: 04/27/2021
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: chills; fever; achy joints; headache; metallic taste; loss of appetite/lost appetite/no appetite; very weak; tired; uncontrollable teeth chattering; This is a spontaneous report from a contactable consumer (patient). An 82-year-old non-pregnant female patient (patient was not pregnant at the time of vaccination) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL 9266), via an unspecified route of administration, administered in Arm Left on 15Feb2021 (at the age of 82-years-old) at a single dose for covid-19 immunisation. Medical history included Hashimoto disease and known allergies: penicillin. Concomitant medications patient received in two weeks included nebivolol hydrochloride (BYSTOLIC); rosuvastatin calcium (CRESTOR); levothyroxine. The patient previously took first dose of BNT162B2 (Lot number: EN-5318) on 25Jan2021 at 02:15 PM in the left arm at a single dose for covid-19 immunisation. On 20Jan2021 at 09:00 PM, the patient experienced chills, fever, achy joints, headache, metallic taste, loss of appetite which lasted for 2 days. On the 5th day after vaccine, I lost appetite again felt very weak and tired all day and by evening I spiked a fever 102.2 with uncontrollable teeth chattering. The same occurred 6th day, metal taste, no appetite, fever 101.2. Today is 7th day, still no appetite and temp are normal. 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. No treatment was received for the adverse events. The patient underwent lab tests and procedures which included body temperature: 102.2 on 20Feb2021, 101.2 on 21Feb2021 and normal on 22Feb2021. The patient was recovering from all the events.

Other Meds: BYSTOLIC; CRESTOR; LEVOTHYROXINE

Current Illness:

ID: 1261570
Sex: F
Age:
State: NE

Vax Date: 02/06/2021
Onset Date: 02/12/2021
Rec V Date: 04/27/2021
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: Started feeling like kind of small lumps in that muscle or little below; redness; Muscle soreness; itching; This is a spontaneous report received from a contactable consumer (patient) via Medical Information Team. A 77-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Batch/Lot Number: EN6201, expiry date: unknown), via an unspecified route of administration on 06Feb2021 (at the age of 77-years-old) at a single dose for COVID-19 immunisation. The patient's medical history was not reported. Concomitant medication included DILTIAZEM. Patient stated I take Tiadylt and it is, I think maybe to dilate blood vessels and rest of the stuff is over the counter. The patient received the vaccine on 06Feb2021 and experienced some muscle soreness. Patient stated, I just wanted to report that I received a Pfizer Covid vaccine on February 6th and experienced some muscle soreness. But on the 12Feb2021, I started feeling like kind of small lumps in that muscle or little below and some redness and by Saturday, redness was about three and a half inches in length and two inches wide and lumps are still there, you could see the lumps. Also, I could feel that knot, it is probably like an inch and a half big knot. I am just thinking if it was reaction. It itched a lot but I didn't really have any pain or discomfort with it, it just was red and little warmer to touch. No treatment was received for the events. The outcome of redness and vaccination site lump was reported as recovering, while the outcome of itching and muscle soreness was unknown. Follow-up attempts are completed. No further information is expected.

Other Meds: DILTIAZEM

Current Illness:

ID: 1261571
Sex: F
Age:
State: CA

Vax Date:
Onset Date:
Rec V Date: 04/27/2021
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: Sudden low back pain; stiffness; This is a spontaneous report from a contactable consumer. The consumer reported similar events for two patients, this is the 2nd of 2 reports. A female patient of an unspecified age received the second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of the same vaccine for covid-19 immunization on an unspecified date. The patient experienced sudden low back pain and stiffness on an unspecified date a few hours after receiving her second vaccination. The outcome of the events was unknown. No follow-up attempts are needed. Information on the lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021154727 same drug/reporter, different patient/event

Other Meds:

Current Illness:

ID: 1261572
Sex: M
Age:
State: MT

Vax Date: 02/10/2021
Onset Date: 02/12/2021
Rec V Date: 04/27/2021
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: total body hives, fatigue; total body hives, fatigue; This is a spontaneous report from a contactable consumer (patient). A 69-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: el9266), via an unspecified route of administration on right arm on 10Feb2021 (at the age of 59-year-old) as single dose for COVID-19 immunisation. Medical history included hypertension and hyperlipidaemia and covid-19 prior vaccination. No known allergies to medications, food, or other products. Patient received unspecified other medications within 2 weeks of vaccination. The patient experienced total body hives and fatigue on 12Feb2021 08:00 AM. The events were considered as non-serious. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient was treated with antihistamine. The patient recovered from both the events on an unspecified date in 2021.

Other Meds:

Current Illness:

ID: 1261573
Sex: F
Age:
State:

Vax Date: 02/14/2021
Onset Date: 02/14/2021
Rec V Date: 04/27/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: soreness of the injection arm; This is a spontaneous report from a non-contactable reporter. A 27-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH mRNA COVID-19 VACCINE, Solution for injection), dose 1 in the left arm on 14Feb2021 (Batch/Lot number EN6201) as a SINGE DOSE for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The patient's medical history and concomitant medications was not reported. The patient did not do a test Covid post vaccination. The patient did not receive any treatment. Patient did not receive any other vaccine in four weeks. On 14Feb2021 after the first dose of the vaccine, the patient experienced soreness of the injection arm. Outcome of the event was recovered. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1261574
Sex: F
Age:
State: NJ

Vax Date: 02/14/2021
Onset Date: 02/15/2021
Rec V Date: 04/27/2021
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: dizziness; She lifted her head and the room was spinning. It as weird. It has abided somewhat. She is a little foggy; This is a spontaneous report from a contactable nurse. A 66-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection and Batch/Lot Number: N6201) via an unspecified route of administration in Left arm on 14Feb2021 17:00 as single dose for COVID-19 immunization (66-year age at Vaccination). The patient medical history and concomitant medications were not reported. The patient was vaccinated with the Pfizer and experienced dizziness on 15Feb2021 6:15 am at the gym, the patient had to stop and drink water. The patient doesn't see that listed unless a side effect of severe allergic reactions. She is wondering if this is a side effect. On an unspecified date in 2021 she lifted her head and the room was spinning. It as weird. It has abided somewhat. She is a little foggy. She has a friend who is a nurse who said her fellow nurse had her first dose of the vaccine and had dizziness as well. She doesn't have that nurses information but will pass on that she should call in and report as well. Outcome of the events was not recovered.

Other Meds:

Current Illness:

ID: 1261575
Sex: F
Age:
State: SC

Vax Date: 02/09/2021
Onset Date: 02/12/2021
Rec V Date: 04/27/2021
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: welts on face; really itchy spots on face and neck; ears were red, hot, and itchy; ears were red, hot, and itchy; This is a spontaneous report from a contactable consumer(patient).A 63-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number was not reported), dose 2 via an unspecified route of administration on 09Feb2021 as single dose for covid-19 immunisation. Medical history was none.Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection,lot number EM9810) via unspecified route of administration on 20Jan2021 as single dose for covid-19 immunisation, anatomical location was left upper arm muscle. There were no concomitant medications.Patient was took second dose of vaccine on 09Feb2021 and on 12feb2021, night her ears were real hot, she had no other symptoms at all with the vaccine, no headache or fever, her ears were red, hot, and itchy, welts on face are still there and itchy, and her neck, and on 15feb2021, she has 2 spots on two fingers, they have itchy spots on them, little bump on each one. She wondered if this was related to it, it was 3 days after the vaccine, that it started. She was not sure this was an experienced, she was curious to know if it was a side effect. Family medical history relevant to AE was none. she has taken some Benadryl. The outcome of the event was unknown.

Other Meds:

Current Illness:

ID: 1261576
Sex: M
Age:
State: FL

Vax Date: 01/25/2021
Onset Date: 01/25/2021
Rec V Date: 04/27/2021
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: arm was a little sore; Little rash, red dots on inside of bicep; This is a spontaneous report from a contactable consumer(Patient). A 78-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1via an unspecified route of administration, administered in Arm Left on 25Jan2021 16:35 as single dose for covid-19 immunisation. Medical history included mitral valve prolapse. The patient's concomitant medications were not reported. Had Pneumonia shot and yearly Flu shot. Had no reaction. Has no NDC/Lot/Exp to provide for Pneumonia and Flu shot. On 25Jan2021 in evening patient had a little rash on inside part of bicep. There were little red dots. It itched for a while. Next day was gone. Stated he was shrinking and provided height as 5 feet 11 inches. First time the dots were there it itched a little bit, next morning it was gone. Had no reaction to COVID-19 Vaccine. Had no fever, nothing else. Next day his arm was a little sore. Patient clarified rash and red dots occurred on both arms. Patient thought rash and red dots were something else like detergent or he didn't rinse soap off in the shower. his doctor didn't seem to think it was anything serious. No prior vaccinations within 4 weeks. Had a family medical history of diabetes runs in family, but most other people had that in their eighties and nineties.The outcome of the event little rash on inside part of bicep, little red dots was recovered on 26Jan2021 and for other it was unknown.

Other Meds:

Current Illness:

ID: 1261577
Sex: F
Age:
State: IL

Vax Date: 02/22/2021
Onset Date: 02/22/2021
Rec V Date: 04/27/2021
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: The left side of my body feels tingling and numbness; tingling on the left side of my mouth; This is a spontaneous report from a contactable consumer (patient herself). A 54-year-old non-pregnant female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EN6200, Expiry Date: unknown) on 22Feb2021 15:00 via unspecified route of administration in the left arm on at single dose for COVID-19 immunization. The patient denied any medical history. She had no known allergies. The patients concomitant medications were not reported. Subsequently at the same time, after receiving the vaccine, the patient felt tingling and numbness in left side of her body. It started on her left calf, and she could mostly feel numbness and tingling on the left side of her mouth. The reporter assessed the events as non-serious. No emergency room or physician office was involved. No COVID prior vaccination, since the vaccination the patient hadn't been tested for COVID-19. There were no relevant test. It was unknown if the patient received treatment. The outcome of the event was unknown. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1261578
Sex: F
Age:
State: WA

Vax Date: 02/09/2021
Onset Date: 02/09/2021
Rec V Date: 04/27/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011j20a
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Chills, Dizziness, Nausea, Pain, Tachycardia

Symptoms: Tachycardia within 5 minutes of injection. Elevated HR for about 3 days; This is a spontaneous report from a contactable consumer (Patient herself). A 60-year-old non-pregnant female patient received first dose BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN6201, Expiration date: Unknown) via an unspecified route of administration in the left arm on 09Feb2021 12:15 as SINGLE DOSE for covid-19 immunisation. The patient's medical history included genital herpes and gastro oesophageal reflux disease from an unknown date and unknown if ongoing. The patient previously took morphine and flagyl and experienced drug hypersensitivity. The patients concomitant medications were not reported. On 09Feb2021 12:30 she experienced tachycardia within 5 minutes of injection and she had elevated heart rate for about 3 days on. She also had other medications in two weeks. She had no other vaccine in four weeks. The patient underwent lab tests and procedures which included heart rate: elevated. The outcome of event was recovered with sequele.

Other Meds:

Current Illness:

ID: 1261579
Sex: F
Age:
State: WA

Vax Date: 02/18/2021
Onset Date: 02/18/2021
Rec V Date: 04/27/2021
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: 1st day: sleepy; 2nd day: some achiness at injection sight; 2nd day: some achiness at injection sight and body; 3rd day: occasional light diarrhea; discomfort; This is a spontaneous report from a contactable consumer or other non-HCP (Patient herself). A 79-year-old female (not pregnant) patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EN6200, Expiration date: Not reported) via an unspecified route of administration in the left arm on 18Feb2021 09:45 as SINGLE DOSE for covid-19 immunisation. Medical history included drug hypersensitivity from an unknown date and unknown if ongoing. Concomitant medications included omeprazole (OMEPRAZOLE) and paracetamol (TYLENOL 8 HOUR). The patient experienced on 18Feb2021 13:00; 1st day: sleepy, 2nd day: some achiness at injection sight and body, 3rd day: occasional light diarrhea, discomfort. The patient was not tested for COVID-19 prior to vaccination and after vaccination. The patient has not received any other vaccine within four weeks. The patient was treated with Tylenol and Pepto-Bismol. The outcome of the events was recovering.

Other Meds: OMEPRAZOLE; TYLENOL 8 HOUR

Current Illness:

ID: 1261580
Sex: M
Age:
State: OH

Vax Date: 02/22/2021
Onset Date: 02/23/2021
Rec V Date: 04/27/2021
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: chills; sweats; nausea; This is a spontaneous report received from a contactable consumer. A 44-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection and Lot Number: EN6198), via an unspecified route of administration in left arm on 22Feb2021 15:15 as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 23Feb2021, the patient experienced chills, sweats, and nausea. The outcome of the events was reported as recovered on an unspecified date.

Other Meds:

Current Illness:

ID: 1261581
Sex: F
Age:
State: CT

Vax Date: 02/22/2021
Onset Date: 02/23/2021
Rec V Date: 04/27/2021
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: Injection site soreness; This is a spontaneous report received from a contactable consumer. A 56-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection and lot number: EL 3247) via an unspecified route of administration in left arm on 22Feb2021 12:00 at single dose for COVID-19 immunization. Patient medical history included ADHD and Depression. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), multivitamin, fish oil and ademetionine (SAM-E). On 23Feb2021 05:30 patient experienced with Injection site soreness. Patient did not receive any treatment. Outcome of event was recovering.

Other Meds: ADDERALL; FISH OIL; SAM-E

Current Illness:

ID: 1261582
Sex: F
Age:
State: OH

Vax Date: 01/26/2021
Onset Date: 01/26/2021
Rec V Date: 04/27/2021
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: Dry cough; This is a spontaneous report from a contactable other Hcp (patient herself). A 40-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection and Lot Number: EK5730) via intramuscular in Left Arm on 26Jan2021 as single dose and second dose via an unspecified route of administration on 18Feb2021 09:00 (Lot Number: EL3249) as single dose for COVID-19 immunization. Medical history included Hypothyroid. Concomitant medications included levothyroxine and liothyronine. On 26Jan2021, he patient experienced dry cough for about five days after first dose of vaccine. On 18Feb2021 at around 9 am, second dose was given and again she started dry cough late that night and it was persisting through today. Patient did not receive any treatment. The outcome of the event was not recovered. No follow up attempts are possible. No further information is expected.

Other Meds: LEVOTHYROXINE; LIOTHYRONINE

Current Illness:

ID: 1261583
Sex: F
Age:
State: FL

Vax Date: 02/06/2021
Onset Date: 02/01/2021
Rec V Date: 04/27/2021
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: lymph node swollen; lower in arm only pain around shot area; Chills; This is a spontaneous report from a contactable consumer (patient). A female patient of unknown age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via unknown route of administration on 06Feb2021 in right arm at single dose for COVID-19 immunisation. Medical history and Concomitant medications were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 16Jan2021 for Covid-19 immunization and experienced very bad arm pain on injection arm, tiredness/fatigue, mild headache, chills, and feeling unwell. It was reported that patient experienced lower in arm only pain around shot area, lymph node swollen and sore still today and chills all in Feb2021. No treatment received for adverse events. The outcome of lymphadenopathy was not recovered, vaccination site pain was unknown, chills was recovered in Feb2021. Information about Lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1261584
Sex: M
Age:
State: OH

Vax Date: 02/13/2021
Onset Date: 02/14/2021
Rec V Date: 04/27/2021
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: her husband experienced only some sore arm.; This is a spontaneous report from a contactable consumer (wife). A 68-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9267; Expiration Date: 31May2021) via unknown route of administration in right arm on 13Feb2021 as single dose for COVID-19 immunization. Medical history and Concomitant medication were not reported. It was reported that the patient experienced only some sore arm on 14Feb2021. The outcome of event was recovered in 2021. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1261585
Sex: F
Age:
State: IL

Vax Date: 02/15/2021
Onset Date: 02/01/2021
Rec V Date: 04/27/2021
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: Flushing in my face, in my cheeks and the redness; Flushing in my face, in my cheeks and the redness; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL3249; Expiration Date: May2021) via an unspecified route of administration, administered in right arm on 15Feb2021 09:30 as single dose for COVID-19 immunisation. Medical history included fibromyalgia, migraine and ongoing asthma. Concomitant medications included duloxetine at 50mg, amitriptyline at 50mg, topiramate at 150mg and fluticasone propionate (FLOVENT) for asthma with a dosage regimen of 2 Sprays one in morning and one in the evening. It was reported that Yesterday patient went to get the shot (clarified as Covid-19 Vaccine Pfizer, 1st shot) in about 9:30 in the morning and know that patient listed all the side effects, you can go ahead and get from it and the only thing that patient experienced shortly after it was flushing in face, in cheeks and the redness in Feb2021 and I still do have that today. For treatment patient stated, "No, I took a tiny bit of Benadryl this morning, since the, if it would help like lessen the redness but it seems like it lightly helped it because I woke up this morning and I was like oh my god I am still red, it seems like lightly helped." The outcome of the events was not recovered. No follow-up attempts are possible. No further information is expected.

Other Meds: DULOXETINE; AMITRIPTYLINE; TOPIRAMATE

Current Illness: Asthma

ID: 1261586
Sex: F
Age:
State: OH

Vax Date: 02/17/2021
Onset Date: 02/17/2021
Rec V Date: 04/27/2021
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: Mild pain at injection site; Slight headache; Mild fatigue; This is a spontaneous report from a contactable consumer(patient). A 65-year-old female non-pregnant patient received BNT162B2((PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), intramuscularly in the left arm on 17Feb2021 11:00 (Lot Number: EL9266) at single dose for Covid-19 immunization. Medical history included asthma, mitral valve prolapses, gastroenteritis and leiomyoma. (Two weeks after receiving BNT162B2) the patient's concomitant medications included Calcium, Vitamin D3, Cranberry capsules and Turmeric. The past medications included Penicillin, Vancomycin, Levaquin, Ceftin and experienced known allergies to Penicillin, Vancomycin, Levaquin, Ceftin. Prior vaccination with BNT162B2 the patient had not experienced any covid symptoms. The patient reported that she was not on any other vaccine till four weeks after receiving BNT162B2. No Covid test were conducted post BNT162B2 vaccination. On 17Feb2021 19:00, the patient experienced mild pain at injection site, slight headache, mild fatigue. At the time of report, the outcome of the events mild pain at injection site, slight headache and mild fatigue was recovered on an unspecified date of 2021. The patient had not taken any treatment medications for the experienced events.

Other Meds: CRANBERRY; TURMERIC [CURCUMA LONGA]; CALCIUM; VITAMIN D3

Current Illness:

ID: 1261587
Sex: M
Age:
State: NJ

Vax Date: 02/15/2021
Onset Date: 02/16/2021
Rec V Date: 04/27/2021
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: Swelling in lymph node area under left arm and sensitive to touch.; This is a spontaneous report from a contactable other HCP (patient). A 57-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9266), via an unspecified route of administration in left arm on15Feb2021, at 09:15 (at the age of 57-year-old) as a single dose for COVID-19 immunisation. The patient medical history included IGA Nephropathy. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient concomitant medication included atorvastatin, losartan and aspirin. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3302), via an unspecified route of administration in left arm on 25Jan2021, at 09:15 for COVID-19 immunisation. On 16Feb2021 at 05:00, the patient experienced swelling in lymph node area under left arm and sensitive to touch. The patient treatment details for the event was unknown. The outcome of the event swelling in lymph node area under left arm and sensitive to touch was unknown.

Other Meds: ATORVASTATIN; LOSARTAN; ASPIRIN [ACETYLSALICYLIC ACID]

Current Illness:

ID: 1261588
Sex: F
Age:
State: AZ

Vax Date: 02/17/2021
Onset Date: 02/17/2021
Rec V Date: 04/27/2021
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: menstrual bleeding occurred after receiving the shot, this was early for the cycle; menstrual bleeding occurred after receiving the shot, this was early for the cycle and lasted 2-3 days.; This is a spontaneous report from a contactable Other HCP (patient). A 33-year-old female non-pregnant patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9267) via an unspecified route of administration, on 17Feb2021 at 07:45 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. The patient medical history was reported as none. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient concomitant medication included multivitamin, ascorbic acid (VITAMIN C), colecalciferol (VITAMIN D), cyanocobalamin (VITAMIN B12). The patient did not receive any other vaccine within 4 weeks prior to the vaccine. The patient previously took Tetracycline and experienced allergy. On 17Feb2021, at 11:00 the patient experienced menstrual bleeding after receiving the shot, this was early for the cycle and lasted 2-3 days. The patient did not receive any treatment for the event menstrual bleeding occurred after receiving the shot, this was early for the cycle and lasted 2-3 days. The outcome of the event was recovered on an unknown date in Feb2021 while for other event menstrual bleeding occurred after receiving the shot, this was early for the cycle (Irregular menstruation) was unknown.

Other Meds: VITAMIN C [ASCORBIC ACID]; VITAMIN D [COLECALCIFEROL]; VITAMIN B12 [CYANOCOBALAMIN]

Current Illness:

ID: 1261589
Sex: F
Age:
State: CA

Vax Date:
Onset Date:
Rec V Date: 04/27/2021
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: Killer headache; Waves of nausea; General fatigue; This is a spontaneous report from a contactable consumer (patient herself). A 37-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number and expiration date were unknown), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. The patient's medical history was not reported. Concomitant medications included ergocalciferol (VITAMIN D), ethinylestradiol, norgestimate (ORTHO TRI-CYCLEN); Both from an unspecified date and ongoing. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number and expiration date were unknown), as a single dose for COVID-19 immunisation and experienced entire body tingling on day 2 for a full week, very heavy sweats and just body felt hot all over on day3/4 after dose, body just felt weird and off on full week and patient did not receive treatment medications for the reactions. The reactions were recovered now. It was reported that, 2nd dose patient had more typical side effects. Killer headache on an unspecified date for about 36 hours, beginning 12 hours after shot. Also waves of nausea and general fatigue on an unspecified date. The outcome of the events was unknown. Information about lot/ batch number has been requested.

Other Meds: VITAMIN D [ERGOCALCIFEROL]; ORTHO TRI-CYCLEN

Current Illness:

ID: 1261590
Sex: F
Age:
State: MI

Vax Date: 02/17/2021
Onset Date: 02/18/2021
Rec V Date: 04/27/2021
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: Bad headache; Stomach ache; Chills; Hot flashes; Aches all over; Fever; Nausea; This is a spontaneous report from a contactable consumer (patient herself). A 47-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL9267), via an unspecified route of administration in left arm on 17Feb2021 at 18:30 (at the age of 47-year-old) as a single dose for COVID-19 immunisation. The patient's medical history included Hashimoto's disease, endometriosis, GERD (gastrooesophageal reflux disease). Known allergies were none. Concomitant medication included ethinylestradiol, norethisterone acetate (JUNEL) received in two weeks for birth control. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL3247) on 27Jan2021 at 18:00 as a single dose in left arm for COVID-19 immunisation. The patient did not receive other vaccine in four weeks. The patient was not diagnosed with COVID prior vaccination. The patient has not tested for COVID post vaccination. The patient experienced bad headache, stomach ache, chills, hot flashes, aches all over, fever, nausea on 18Feb2021 at 06:00 AM. The adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive treatment medication for the adverse events. The outcome of the events was recovering.

Other Meds: JUNEL

Current Illness:

ID: 1261591
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 04/27/2021
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: Experiencing moderate fatigue; This is a spontaneous report based on information received by Pfizer (Pfizer colleague). A contactable consumer reported that a patient of an unspecified Gender and age received second dose BNT162b2 (Comirnaty, Formulation: Solution for injection), via an unspecified route of administration on unknown date at single dose for COVID-19 immunization. The patient medical history and Concomitant medication were not reported. Historical vaccine included BNT162b2 (Comirnaty) for Covid-19 immunisation. On an unspecified date, patient reported that they were experiencing moderate fatigue (tiredness) after their 2nd COVID vaccination (Pfizer/BioNTech). Outcome for event was unknown. Information about lot/ batch number has been requested.

Other Meds:

Current Illness:

ID: 1261592
Sex: F
Age:
State: AZ

Vax Date: 02/06/2021
Onset Date: 02/10/2021
Rec V Date: 04/27/2021
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: About 3 to 4 days after injection,I noticed swollen nodes under my left(injection arm); Rash on left,Rash worsened on my left arm expanded to my torso, right arm and legs; This is a spontaneous report from a contactable Other health care professional. A 49-year-old female non-pregnant patient (Other HCP) received first dose BNT162B2 (Pfizer Covid vaccine, Solution for injection, Lot number: EN5318) via an unspecified route of administration in arm left on 06Feb2021 11:00 AM at single dose for COVID-19 immunisation. Medical history included Hashimoto's thyroiditis. Concomitant medications included Levothyroxine, vitamin D (COLECALCIFEROL). No covid prior vaccination and no covid tested post vaccination. On 10Feb2021, the patient reported that about 3 to 4 days after injection, patient noticed swollen lymph nodes under her left arm (injection arm) and rash on left arm. Rash worsened on patient left arm, expanded to her torso, right arm, and legs. The patient received treatment for the events via unspecified treatment medications as anti-itch meds, antihistamine and steroid pack. The outcome for the events was not recovered.

Other Meds: LEVOTHYROXINE; VITAMIN D [COLECALCIFEROL]

Current Illness:

ID: 1261593
Sex: M
Age:
State: SD

Vax Date: 02/23/2021
Onset Date:
Rec V Date: 04/27/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025j20-2A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site swelling, Limb discomfort

Symptoms: his neck pain; This is a spontaneous report from a sponsored program received from contactable consumer (patient). A male patient of an unspecified age received first dose of bnt162b2 (Pfizer Covid-19 Vaccine, Solution for injection), via an unspecified route of administration on 23Feb2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported as patient received first dose today and was asking when he can take pain medications like Advil for his neck pain on an unspecified date in 2021. He believes the neck pain was not related to the vaccine dose. The Clinical outcome of the event (neck pain) was unknown.; Sender's Comments: There is not a reasonable possibility that the event neck pain was related to BNT162B2 based on the available information.

Other Meds:

Current Illness:

ID: 1261594
Sex: F
Age:
State: NY

Vax Date: 02/12/2021
Onset Date: 02/14/2021
Rec V Date: 04/27/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: numbness in mouth; cold sore; lip swelling and facial itching; lip swelling and facial itching; This is a spontaneous report received from two contactable nurses (one is patient). A 33-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EZ9261, Expiration Date: May2021), via an unspecified route of administration on left arm on 12Feb2021 at 0.3 mL, single for COVID-19 immunisation. Medical history included cold sore (history of cold sores for 15 years, takes Valtrex to treat it). Concomitant medication included valaciclovir hydrochloride (VALTREX) taken for cold sore. The patient stated that she received the COVID-19 vaccine last Friday, 12Feb2021, states she was eligible at her employer, it was done at (pharmacy name). States since Sunday, 14Feb2021, she has experienced lower lip swelling and facial itching. States she also developed a cold sore on 15Feb2021 but has a history of cold sores for 15 years, takes Valtrex to treat it. States she also has numbness inside of her mouth on 18Feb2021. States she has no clue if it has anything to do with the vaccine. The outcome of the events was reported as not recovered.

Other Meds: VALTREX

Current Illness:

ID: 1261595
Sex: F
Age:
State: IL

Vax Date: 02/15/2021
Onset Date: 02/16/2021
Rec V Date: 04/27/2021
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: the soreness is quite evident; swelling at the injection site; This is a spontaneous report from a contactable consumer (patient). A 78-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9267 and expiration date was unknown) via an unspecified route of administration on left arm on 15Feb2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced swelling at the injection site on 16Feb2021 and the soreness is quite evident on an unspecified date. The outcome of swelling at the injection site was not recovered and soreness is quite evident was unknown.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 636,615

Page last modified: 03 October 2021 5:28pm