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: 1165576
Sex: F
Age:
State: AZ

Vax Date: 02/05/2021
Onset Date:
Rec V Date: 04/04/2021
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: Slight cellulitis at the injection site; Sore arm; Fever of about 102.4?; Nausea; A spontaneous report was received from a consumer who is a 79-year-old female patient that received Moderna's COVID-19 vaccine (mRNA-1273) vaccine and experienced cellulitis at injection site/injection site cellulitis, sore arm/pain in extremity, fever to 102.4/pyrexia, nausea. The patient's medical history was not reported. Products known to have been used by the patient, within two weeks prior to the event were not reported. On 05-FEB-2021, prior to the onset of events, the patient received the first dose of two planned doses of mRNA-1273 (Batch number:011M20A) intramuscularly on arm for prophylaxis of COVID-19 infection. On an unknown date, after receiving the first dose of vaccine, patient experienced feeling a sore arm, like a slight cellulitis at injection site, fever of 102.4 and nausea. The event injection site cellulitis was considered as serious (Medically Significant). Treatment medication included alcohol which was used at the injection site. Laboratory tests were not reported. Action taken with mRNA-1273 in response to the event was unknown. The outcome of the events experienced cellulitis at injection site/injection site cellulitis, sore arm/pain in extremity, fever to 102.4/pyrexia and nausea were considered as unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1165577
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 04/04/2021
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: I am experiencing Bells' palsy and don't knowwhat to do about it.; A spontaneous report was received from a consumer concerning a unknown age, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Bell's palsy/facial paralysis. The patient's medical history was not provided by the reporter. Concomitant medications were not reported . On unspecified date, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) through unknown route for prophylaxis of COVID-19 infection. On unspecified date, after vaccination patient experienced Bell's palsy. Treatment for the event was not provided. Lab details were not provided. The event was medically significant. Action taken with mRNA-1273 in response to the events was not applicable. The outcome of Bell's palsy was considered unknown.; Reporter's Comments: This case concerns a female of unknown age who had a serious unexpected event of Bell's palsy (facial paralysis). Event onset occurred with unknown latency after first dose mRNA-1273. Treatment not reported. Event outcomes unknown. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1165578
Sex: M
Age: 92
State: OH

Vax Date: 02/22/2021
Onset Date: 02/22/2021
Rec V Date: 04/04/2021
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: Fell; Felt like he was dying; couldn't taste, and had a terrible taste in his mouth; Could not smell; Stomach hurt; A spontaneous report was received from a consumer concerning a 92-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced could not taste and had terrible taste in his mouth (ageusia), could not smell (anosmia), his stomach hurt (abdominal pain upper), felt like he was dying (feeling abnormal) and he fell (fall). The patient's medical history included hospitalization due to COVID-19. No relevant concomitant medications were reported. The patient received their first of two planned doses of mRNA-1273 (Batch number not provided) an unspecified date. On 22 Feb 2021, two hours prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly for prophylaxis of COVID-19 infection. Two hours after the vaccination, the patient could not taste, and had a terrible taste in his mouth The patient could not smell and his stomach hurt. The patient felt like he was dying. On 23 Feb 2021, the patient fell. 911 was called and the patient was hospitalized. Treatment for the event included electrolytes. The patient had an abnormal electrocardiogram (EKG The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable. The outcome of the events, could not taste and had a terrible taste in his mouth (ageusia), could not smell (anosmia), his stomach hurt (abdominal pain upper), felt like he was dying (feeling abnormal) and he fell (fall), were unknown.; Reporter's Comments: Very limited information regarding the event has been provided at this time. Noting advance age is a risk factor. Noting the history of advance age and previous COVID infection may remain as risk factors. Further information has been requested.

Other Meds:

Current Illness:

ID: 1165579
Sex: M
Age: 76
State: AZ

Vax Date: 01/22/2021
Onset Date: 01/22/2021
Rec V Date: 04/04/2021
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: COVID arm bullseye; Arm was red and swollen; Arm was red and swollen; His arm started itching; Oxygen level dropped; Little aching and fatigued; A rash on the same arm as his injection; Little aching and fatigued; A spontaneous report was received from a consumer concerning a 76-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the following: little aching and fatigued (fatigue/pain), drop in oxygen levels(hypoxia), his arm started itching (pruritis),arm was red and swollen (erythema/peripheral swelling), rash on the same arm as injection (rash), and COVID arm bullseye (vaccination site reaction). The patient's medical history was not provided. Concomitant medications reported were metoprolol. On 22 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 041L20A) intramuscularly for prophylaxis of COVID-19 infection. On 22 Jan 2021, the patient felt fatigued and a little aching after receiving the vaccine. The patient's oxygen levels were being monitored and had dropped from an average of 95 to 90-91. On 2 Feb 2021, the patient's arm started itching. By 3 Feb 2021, the patient's arm was red and swollen. On 4 Feb 2021, the patient developed the "COVID arm bullseye" that appeared to be swollen, hot and spreading down towards the elbow. On 9 Feb 2021, the COVID arm bullseye was bigger than a baseball, was starting to fade in color , but had spread further almost to the elbow. No treatment information was provided. Action taken with mRNA-1273 in response to the events was unknown. The outcome of events, little aching and fatigued, drop in oxygen levels, arm started itching, arm was red and swollen, rash on the same arm as injection, and COVID arm bullseye, was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.

Other Meds: METOPROLOL SUCCINATE

Current Illness:

ID: 1165580
Sex: F
Age:
State: OH

Vax Date: 02/27/2021
Onset Date: 02/28/2021
Rec V Date: 04/04/2021
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: I sat down on floor passed out for 5 mins; light headedness, dizzy; Sweaty; arm soreness; legs felt achy; A spontaneous report was received from a consumer who was also a 65-year old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced sat down on floor passed out for 5 mins/ loss of consciousness, legs felt achy/ pain in extremity, light headedness, dizzy/ dizziness, sweaty/hyperhidrosis, and arm soreness/ vaccination site pain. The patient's medical history was not provided. Concomitant medications included fluticasone propionate and salmeterol xinafoate and salbutamol. On 27 Feb 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: 025A21A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 28 Feb 2021, the patient had arm soreness and in night her legs felt achy. On 01 Mar 2021, the patient suddenly had light headedness, dizzy, and sweaty. The patient sat down on floor passed out for five minutes. The patient reported feeling better. Treatment for the events included Ibuprofen and paracetamol. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the events, the patient sat down on floor passed out for five minutes was considered as resolved on 1 Mar 2021. The outcome of the events, the patient suddenly had light headedness, dizzy, and sweaty was considered recovering.; Reporter's Comments: This case concerns a 65-year-old female with serious unexpected events of loss of consciousness along with nonserious unexpected dizziness, hyperhidrosis, pain in extremity and expected vaccination site pain. Event onset occurred 2 days after the first dose of mRNA-1273. Treatment included Motrin and Tylenol. Events resolving. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Other Meds: WIXELA INHUB; ALBUTEROL [SALBUTAMOL]

Current Illness:

ID: 1165581
Sex: M
Age: 79
State: GA

Vax Date: 02/01/2021
Onset Date: 02/11/2021
Rec V Date: 04/04/2021
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: rash from the elbows to the wrists in both arms; Moderna arm; a very red splotch that was 4x3inches for the first 3 days but know it has been spreading reaching; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 17-Feb-2021 and was forwarded to Moderna on 18-Feb-2021. This spontaneous case was reported by a physician assistant (subsequently medically confirmed) and describes the occurrence of RASH (rash from the elbows to the wrists in both arms) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event (no medical history reported. ). Concomitant products included SIMVASTATIN (ZOCOR) for an unknown indication. On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced RASH (rash from the elbows to the wrists in both arms) (seriousness criterion medically significant), PERIPHERAL SWELLING (Moderna arm) and RASH MACULAR (a very red splotch that was 4x3inches for the first 3 days but know it has been spreading reaching). At the time of the report, RASH (rash from the elbows to the wrists in both arms), PERIPHERAL SWELLING (Moderna arm) and RASH MACULAR (a very red splotch that was 4x3inches for the first 3 days but know it has been spreading reaching) outcome was unknown. 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 concerns a 79 Y/O M with a serious unexpected event of rash, and nonserious unexpected rash macular and peripheral swelling. Event onset 11 days after first dose mRNA-1273. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: This case concerns a 79 Y/O M with a serious unexpected event of rash, and nonserious unexpected rash macular and peripheral swelling. Event onset 11 days after first dose mRNA-1273. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Other Meds: ZOCOR

Current Illness:

ID: 1165582
Sex: F
Age: 58
State: PA

Vax Date: 02/26/2021
Onset Date: 02/26/2021
Rec V Date: 04/04/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Pyrexia, White blood cell count decreased

Symptoms: mild pain at the injection site of vaccine; after diarrhea, she had blood dripping in the toilet; pain in kidney area; pains in abdomen/soreness in lower abdomen; nausea; throwing up; chills; A spontaneous report was received from a consumer, concerning a female patient of 58 age , who received Moderna's COVID-19 vaccine and experienced after diarrhea, she had blood dripping in the toilet (diarrhea haemorrhagic), pain in kidney area (back pain), pains in abdomen/soreness in lower abdomen (abdominal pain), nausea, throwing up (vomiting), chills, and mild pain at the injection site of vaccine (vaccination site pain). History of the patient was not provided. Concomitant product use was not provided by the reporter. On 26Feb2021, prior to the onset of events, the patient received his first of two planned doses of mRNA-1273 (lot number 025A21A) via intramuscular route in her right arm for COVID-19 infection prophylaxis. On 26Feb2021, after first dose of vaccine, the patient had intense lower abdominal pain, cramping, nausea, vomiting and diarrhea. Patient reported chills with a temperature of 98.9. Patient noticed blood dripping after diarrhea, until 2 days after vaccination (Sunday). Patient states she has less cramps today, but pain in the loin (kidney area). she also had mild pain at the injection site of the vaccine. Action taken with mRNA-1273 in response to the event Abdominal pain, Muscle spasms, Nausea, Vomiting, Diarrhoea, Chills, Tremor, Haemorrhage, Renal pain, and Vaccination site pain was reported as unknown. The outcome of the event Abdominal pain, Nausea, Vomiting, Chills, Haemorrhage was considered to be unknown. Renal pain and Vaccination site pain was considered to be recovered/ resolved at the time of this report. Haemorrhage was considered to be medically significant. No treatment medication was reported.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time. Further information has been requested.

Other Meds:

Current Illness:

ID: 1165583
Sex: F
Age: 65
State: MA

Vax Date: 02/27/2021
Onset Date: 02/28/2021
Rec V Date: 04/04/2021
Hospital: Y

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: Blood pressure was 200/100; Very dizzy; Could not lie down without things spinning around; Felt unsteady; Nauseous; A spontaneous report was received from a consumer concerning a 65-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced blood pressure raise (200/100) with dizziness, nausea, vertigo and gait disturbance. The patient's medical history was not provided. Concomitant medications were not reported. On 27 Feb 2021, 16 hours prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch number: 010A21A) intramuscularly for the prophylaxis of COVID-19 infection. On 28 Feb 2021, the patient woke up to turn over and was very dizzy. The dizziness continue most of the following day, and the patient was also nauseous and could not lie down without things spinning around. The patient stayed upright and felt unsteady so they had to hold on to the walls to move around. The patient was taken to urgent care where her blood pressure was 200/100. She was taken to the hospital where she remained for two days and tests were taken. Treatment medications included nitroglycerin and acetylsalicylic acid. The patient was released from the hospital on 02 Mar 2021. She had an appointment with her PCP (primary care physician) on Friday 05 Mar 2021 for follow-up. Action taken with mRNA-1273 in response to the events was unknown. The outcomes of the events were reported as unknown.; Reporter's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.

Other Meds:

Current Illness:

ID: 1165584
Sex: F
Age: 83
State: AZ

Vax Date: 02/26/2021
Onset Date: 02/26/2021
Rec V Date: 04/04/2021
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: Blood pressure dropped down to 85; Patient could not get out of bed; Slept on and off; Temperature of 100.4 ?F; More than a shivering, like having convulsions; cold; Shaking; Left arm was a little bit tender; A spontaneous case was reported by a consumer concerning an 83-year-old female patient who experienced More than a shivering, like having convulsions, feeling cold/chilliness, shaking, Left arm was a little bit tender, blood pressure dropped down to 85, patient could not get out of bed, slept on and off) and temperature of 100.4 ?F. The patient's past medical history was not provided. Concomitant medications included blood thinners (unspecified). On 26-Feb-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 26-Feb-2021, the patient experienced SEIZURE (More than a shivering, like having convulsions), NASOPHARYNGITIS (Cold), TREMOR (Shaking) and TENDERNESS (Left arm was a little bit tender). On an unknown date, the patient experienced BLOOD PRESSURE DECREASED (Blood pressure dropped down to 85), BEDRIDDEN (Patient could not get out of bed), SLEEP DISORDER (Slept on and off) and PYREXIA (Temperature of 100.4 ?F). Treatment information was not provided for these events. The action taken with mRNA-1273 in response to these events was unknown. On 26-Feb-2021, SEIZURE (More than a shivering, like having convulsions), NASOPHARYNGITIS (Cold) and TREMOR (Shaking) outcome was unknown. On 28-Feb-2021, TENDERNESS (Left arm was a little bit tender) outcome was unknown. At the time of the report, BLOOD PRESSURE DECREASED (Blood pressure dropped down to 85), BEDRIDDEN (Patient could not get out of bed), SLEEP DISORDER (Slept on and off) and PYREXIA (Temperature of 100.4 ?F) outcome was unknown. The patient consented for safety follow-up.; Reporter's Comments: Based on the current available information which includes a temporal association between the use of the product and the start date of the reported event, and excluding any other etiology, a causal relationship with the event cannot be excluded

Other Meds:

Current Illness:

ID: 1165585
Sex: F
Age: 80
State: PA

Vax Date: 02/18/2021
Onset Date: 02/22/2021
Rec V Date: 04/04/2021
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: significant amount, huge hives were probably 2 inches in diameter all over her body; hives on her trunk breast little on legs, arms, and hair; A spontaneous report was received from a family member concerning an 80-year old, female patient who developed hives on her trunk, breast, hair, a little on legs and arms, hives were huge and a significant amount(Angioedema, Urticaria). The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 18 Feb 2021, approximately four days prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (batch number 023M20A) intramuscularly for prophylaxis of COVID-19 infection. On 22 Feb. 2021, the patient experienced hives on her trunk, breast, hair, a little on legs and arms. The hives were huge and a significant amount. They were probably 2 inches in diameter all over her body. The patient took a 7 days course of prednisone as advised by her HCP. The symptoms went away after finishing a 7 days course of prednisone but returned 2 days after finishing the medication. The patient is currently taking over-the-counter claritin and pepsid as advised by her HCP to help alleviate the symptoms. Treatment for the event included a 7 days course of prednisone, over-the-counter claritin and pepsid. Action taken with mRNA-1273 in response to the event was not provided. The outcome of events were considered not recovered.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1165586
Sex: F
Age: 72
State: NJ

Vax Date: 02/10/2021
Onset Date: 03/01/2021
Rec V Date: 04/04/2021
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: disorientation; couldn't properly respond/was speaking gibberish; weakness; cough; now she's dealing with fluctuating fever/running a slight temperature; Chills; was physically shaking, like a convulsion; doesn't feel she's completely okay; A spontaneous report was received from a consumer, who was the husband of a 72-year-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced extreme chills, was physically shaking, like a convulsion (seizure), disorientation, couldn't properly respond/was speaking gibberish (disorganized speech), weakness (asthenia), fluctuating fever/running a slight temperature (pyrexia), cough, and doesn't feel she's completely okay (malaise). The patient's medical history was not provided by the reporter. Concomitant medications included acyclovir. On 12 MAR 2021, the patient received their second of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. On the same day, the patient had extreme chills and was physically shaking, like a convulsion where her husband had to hold her up. On 12 Mar 2021, she experienced disorientation, she couldn't properly respond/was speaking gibberish, and had weakness. The husband called 911 and a stroke was ruled out. At the time of the report, the patient was dealing with a fluctuating fever/was running a slight temperature and a cough. The husband didn't feel she was completely ok. Treatment for the events included Gatorade and paracetamol. The reporter considered the events of disorientation and couldn't properly respond/was speaking gibberish to be disabling. Action taken with mRNA-1273 in response to the events was unknown except for stroke it was resolved. The outcome of the events of chills, was physically shaking, like a convulsion, disorientation, couldn't properly respond/was speaking gibberish, and weakness were unknown. The events of fluctuating fever/running a slight temperature, cough, and doesn't feel she's completely okay were considered not resolved at the time of this report.

Other Meds: ZOVIRAX [ACICLOVIR]

Current Illness:

ID: 1165587
Sex: F
Age: 83
State: NC

Vax Date: 01/12/2021
Onset Date: 02/03/2021
Rec V Date: 04/04/2021
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: heart attack; Admitted to hospital 3Feb2021 oxygen satuation 77; BP elevated; fluid was drained from her gall bladder and antibiotics were started; lot of fluid in her stomach / the fluid was drained from her gall bladder; 2nd dose of vaccine is overdue by 66 days; This spontaneous case was reported by a consumer and describes the occurrence of GALLBLADDER OEDEMA (lot of fluid in her stomach / the fluid was drained from her gall bladder), MYOCARDIAL INFARCTION (heart attack), OXYGEN SATURATION DECREASED (Admitted to hospital 3Feb2021 oxygen satuation 77), BLOOD PRESSURE INCREASED (BP elevated) and CHOLECYSTITIS INFECTIVE (fluid was drained from her gall bladder and antibiotics were started) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Diabetes mellitus, Hypertension, AFib, Congestive heart failure and Pacemaker complication. Concomitant products included AMIODARONE, AMLODIPINE, ASPIRIN [ACETYLSALICYLIC ACID], BUMETANIDE, BUSPIRONE, CYANOCOBALAMIN, APIXABAN (ELIQUIS), VITAMIN D2, ESCITALOPRAM OXALATE (LEXAPRO), GLIPIZIDE, LISINOPRIL, LOSARTAN POTASSIUM (COZAAR), LOSARTAN, MAGNESIUM OXIDE, METOPROLOL, PRAVASTATIN and SPIRONOLACTONE for an unknown indication. On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced GALLBLADDER OEDEMA (lot of fluid in her stomach / the fluid was drained from her gall bladder) (seriousness criterion hospitalization), OXYGEN SATURATION DECREASED (Admitted to hospital 3Feb2021 oxygen satuation 77) (seriousness criterion hospitalization), BLOOD PRESSURE INCREASED (BP elevated) (seriousness criterion hospitalization) and CHOLECYSTITIS INFECTIVE (fluid was drained from her gall bladder and antibiotics were started) (seriousness criterion hospitalization). On 10-Feb-2021, the patient experienced MYOCARDIAL INFARCTION (heart attack) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (2nd dose of vaccine is overdue by 66 days). At the time of the report, GALLBLADDER OEDEMA (lot of fluid in her stomach / the fluid was drained from her gall bladder), MYOCARDIAL INFARCTION (heart attack), OXYGEN SATURATION DECREASED (Admitted to hospital 3Feb2021 oxygen satuation 77), BLOOD PRESSURE INCREASED (BP elevated) and CHOLECYSTITIS INFECTIVE (fluid was drained from her gall bladder and antibiotics were started) was resolving and PRODUCT DOSE OMISSION ISSUE (2nd dose of vaccine is overdue by 66 days) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Feb-2021, Blood pressure measurement: elevated (High) elevated. On 03-Feb-2021, Oxygen saturation: 77 (Low) low. On 10-Feb-2021, Catheterisation cardiac: abnormal (abnormal) a blockage was found. On 10-Feb-2021, Myocardial necrosis marker: elevated (High) elevated. 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. Treatment for the events included cholecystostomy and antibiotics for infection. The coronary artery blockage was deemed to be medically treated. Very limited information regarding these events has been provided at this time. Patient's advanced age along with concomitant medications and underlying conditions may have been contributory for the occurrence of the events. This report also refers to a case of 2nd dose product administration error of 66 days delay for mRNA-1273, lot # unknown. Further information has been requested.; Sender's Comments: Very limited information regarding these events has been provided at this time. Patient's advanced age along with concomitant medications and underlying conditions may have been contributory for the occurrence of the events. This report also refers to a case of 2nd dose product administration error of 66 days delay for mRNA-1273, lot # unknown. Further information has been requested.

Other Meds: AMIODARONE; AMLODIPINE; ASPIRIN [ACETYLSALICYLIC ACID]; BUMETANIDE; BUSPIRONE; CYANOCOBALAMIN; ELIQUIS; VITAMIN D2; LEXAPRO; GLIPIZIDE; LISINOPRIL; COZAAR; LOSARTAN; MAGNESIUM OXIDE; METOPROLOL; PRAVASTATIN; SPIRONOLACTONE

Current Illness:

ID: 1165588
Sex: M
Age:
State: NV

Vax Date: 03/02/2021
Onset Date: 03/03/2021
Rec V Date: 04/04/2021
Hospital: Y

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

Lab Data:

Allergies:

Symptom List: Blood pressure decreased, Chest pain, Chills, Confusional state, Decreased appetite

Symptoms: Unable to walk; Diarrhea; A spontaneous report was received from a consumer concerning a 75-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events diarrhea, unable to walk/gait inability. The patient's medical history was not provided. No relevant concomitant medications were reported. On 2 Mar 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 013A21A) intramuscularly for prophylaxis of COVID-19 infection. On 3 Mar 2021, after the vaccination, he walked 3 miles back to his house. On the 3 Mar 2021, he was unable to walk and he started having diarrhea. On 18 Mar 2021, he was admitted to the hospital because he still could not walk. The relevant lab tests included MRI, EKG, blood test and CT scan with the result all negative. On 20 Mar 2021 the patient is reported to being still admitted to the hospital and his physician stated considering recharging him to a rehab facility. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the event unable to walk was not resolved. The outcome of events diarrhea was unknown.; 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, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1165589
Sex: F
Age: 73
State: NY

Vax Date: 02/11/2021
Onset Date: 02/11/2021
Rec V Date: 04/04/2021
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: Snake-like skin; Red bumps/rashes spread all over the body; Burning rashes; Itching rashes; Sandy-like skin; Leathery skin; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 19-Mar-2021 and was forwarded to Moderna on 19-Mar-2021. This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ICHTHYOSIS (Snake-like skin), RASH ERYTHEMATOUS (Red bumps/rashes spread all over the body), SKIN BURNING SENSATION (Burning rashes) and RASH PRURITIC (Itching rashes) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event (No reported medical history). On 11-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced ICHTHYOSIS (Snake-like skin) (seriousness criterion medically significant), RASH ERYTHEMATOUS (Red bumps/rashes spread all over the body) (seriousness criterion disability), SKIN BURNING SENSATION (Burning rashes) (seriousness criterion disability), RASH PRURITIC (Itching rashes) (seriousness criterion disability), KERATOSIS PILARIS (Sandy-like skin) and LICHENIFICATION (Leathery skin). At the time of the report, ICHTHYOSIS (Snake-like skin), RASH ERYTHEMATOUS (Red bumps/rashes spread all over the body), SKIN BURNING SENSATION (Burning rashes), RASH PRURITIC (Itching rashes), KERATOSIS PILARIS (Sandy-like skin) and LICHENIFICATION (Leathery skin) had not resolved. No concomitant medications reported. Treatment medications included diphenhydramine and 6-day pack prednisone. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1165590
Sex: F
Age: 69
State: NY

Vax Date: 01/19/2021
Onset Date: 02/23/2021
Rec V Date: 04/04/2021
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: another gushing nose bleed; minor nose bleed; fourth nose bleed; third severe nose bleed; second severe nose bleed; This spontaneous case was reported by a consumer and describes the occurrence of EPISTAXIS (second severe nose bleed), EPISTAXIS (third severe nose bleed), EPISTAXIS (fourth nose bleed) and EPISTAXIS (another gushing nose bleed) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Breast cancer. Concurrent medical conditions included Von Willebrand's disease. On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Feb-2021, the patient experienced EPISTAXIS (second severe nose bleed) (seriousness criterion disability). On 25-Feb-2021, the patient experienced EPISTAXIS (third severe nose bleed) (seriousness criterion disability). On 09-Mar-2021, the patient experienced EPISTAXIS (fourth nose bleed) (seriousness criterion disability). On 13-Mar-2021, the patient experienced EPISTAXIS (minor nose bleed). On 18-Mar-2021, the patient experienced EPISTAXIS (another gushing nose bleed) (seriousness criterion disability). On 13-Mar-2021, EPISTAXIS (minor nose bleed) had resolved. In March 2021, EPISTAXIS (fourth nose bleed) had resolved. On 18-Mar-2021, EPISTAXIS (another gushing nose bleed) had resolved. At the time of the report, EPISTAXIS (second severe nose bleed) and EPISTAXIS (third severe nose bleed) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Mar-2021, Computerised tomogram head: normal (normal) Normal frontal sinuses, nose, and frontal lobe of brain. Concomitant product use was not reported. Treatment for the nose bleeds included intravenous desmopressin, aminocapriotic acid, cauterization, and packing.; Sender's Comments: This case concerns a 69 Y/O F with multiple serious unexpected events of severe epistaxis. Event onset 8 days after first dose mRNA-1273. Treated with desmopressin, aminocapriotic acid, cauterization. Events resolved. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Other Meds:

Current Illness: Von Willebrand's disease

ID: 1165591
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 04/04/2021
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: serious medical condition; A spontaneous report was received from a consumer female patient, concerning herself, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced serious medical condition/vaccination adverse event. The patient's medical history was not provided. Concomitant medication was not reported. On an unknown date, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) via unknown route for prophylaxis of COVID-19 infection. On an unknown date, the patient received their second of two planned doses of mRNA-1273 (Lot number: unknown) via unknown route for prophylaxis of COVID-19 infection. On an unknown date, after the first dose of the two planned doses of mRNA-1273, the patient was said to have experienced a serious medical condition. Post second dose of the planned two doses of mRNA-1273, the event became severe. Treatment given was not provided. The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable. The event serious medical condition was reported as resolved on an unknown date.; Sender's Comments: Very limited information regarding the reported event has been provided at this time. Further information has been requested.

Other Meds:

Current Illness:

ID: 1165592
Sex: F
Age: 38
State: CA

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

Symptom List: SARS-CoV-2 antibody test, SARS-CoV-2 test negative

Symptoms: Difficulty breathing, swelling and itchiness in mouth and throat, and dizziness all within 5-10 minutes of taking shot. Used inhaler, took Benadryl. Symptoms subsided within two hours.

Other Meds:

Current Illness:

ID: 1165593
Sex: F
Age: 23
State: TX

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

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

Lab Data:

Allergies: NKDA Hay fever allergies (e.g. pollen)

Symptom List: Ear pain, Hypoaesthesia

Symptoms: Shooting nerve pain down left arm. Numbness and tingling to left arm

Other Meds: N/A

Current Illness: N/A

ID: 1165594
Sex: F
Age: 22
State: TX

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

Vax Type: PNC13
Manufacturer: PFIZER\WYETH
Vax Name: PNEUMO (PREVNAR13)
Lot:
Dose Series: UNK
Vax Route:
Vax Site: LG

Lab Data:

Allergies: Non known

Symptom List: Abdominal pain upper, Dizziness, Dysgeusia

Symptoms: Fever and chills (8:30pm-2:00am next day) Nausea / vomiting (3-4am next day) Extreme back pain (mostly lower back) (2am-7am next day) Red, hot, itchy rash on left side of back / abdomen (I just noticed at 11pm day after, not sure when it began) Extreme fatigue and mental fogginess (8pm day of - still continuing 11pm day after)

Other Meds: I take a multivitamin and vitamin c supplements (supposed to be daily but I often forget)

Current Illness: I randomly felt nauseous for a few hours a week before

ID: 1165595
Sex: F
Age: 29
State: AK

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

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

Lab Data:

Allergies: Avocado, mango

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

Symptoms: Ongoing migraine present for over 48 hours. Nausea, vomiting, back pain, joint pain, neck pain, pain at injection site, fever, chills, fatigue, all lasting for 36 hours.

Other Meds: Morena IUD, multivitamin

Current Illness: None

ID: 1165596
Sex: M
Age: 57
State: HI

Vax Date: 05/22/2014
Onset Date: 05/23/2014
Rec V Date: 04/04/2021
Hospital:

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

Lab Data:

Allergies: None

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

Symptoms: Sudden Sensorineural Hearing Loss in the left ear, including tinnitus and diplacusis. Treated 24 hours after onset with 500mg IV methylprednisolone from Dr. Repeated 45 hours after onset with 500mg IV methylprednisolone. Prescription of 500mg Trental q.d. The hearing normalized after several weeks.

Other Meds: QD: aspirin 100mg, Vitamin C, 20mg Mevacor, Methyl Salicylate ointment

Current Illness: Strained shoulder blade earlier on the day of adverse event.

ID: 1165597
Sex: F
Age: 32
State: PA

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

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

Lab Data:

Allergies: No

Symptom List: Unevaluable event

Symptoms: Swollen painful lymph nodes under left arm, headache, nausea, chills, body aches

Other Meds: Famotidine, vitamin d, lorazepam

Current Illness: None

ID: 1165598
Sex: F
Age: 64
State: FL

Vax Date: 03/31/2021
Onset Date: 03/31/2021
Rec V Date: 04/04/2021
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: Iodine, citrus,various antibiotics, synthroid, mango, potassium in iv

Symptom List: Chills, Dizziness, Injection site pain, Myalgia, Pyrexia

Symptoms: Headache, fever, bone and bodyaches. Inflamed red area at site of injectionwith itching, painful and hot to the touch started within 24 hours after injection. Still red inflamed hot and itchy as of day of report. Fever has resolved, bone and body ache diminished. No betterment as of yet at injection site

Other Meds: Eliquis, tylenol, xanax, metoprolol er, flovent, b complex, armour thyroid,, vit d3

Current Illness: Copd, cfs/me, a fib,fibromyalgia, diabetes

ID: 1165599
Sex: F
Age: 54
State: CA

Vax Date: 03/24/2021
Onset Date: 03/26/2021
Rec V Date: 04/04/2021
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: None

Symptom List: Injection site pain, Pain

Symptoms: Sudden onset of tinnitus in my left ear. Still ongoing as of 10 days later. Very prominent hissing.

Other Meds: None

Current Illness: None

ID: 1165600
Sex: M
Age: 25
State: CT

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

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

Lab Data:

Allergies: None

Symptom List: Injection site pain, Menorrhagia

Symptoms: Went downhill rapidly... Aprox 6 hours after shot was administered I was shaking uncontrollably (freezing sensation) fever 102.6 and commiting. Woke up this morning and felt better but still very much aches and pains and headache

Other Meds: None

Current Illness: None

ID: 1165601
Sex: M
Age: 51
State: IN

Vax Date: 04/01/2021
Onset Date: 04/02/2021
Rec V Date: 04/04/2021
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: Penicillin

Symptom List: Arthralgia, Chills, Headache, Mobility decreased, Myalgia

Symptoms: Note: These symptoms are from the second injection of the vaccine; first was March 11...no problematic symptoms from that one. Symptoms started at midnight on April 2 (10 hours after injection) with chills, not sure if accompanied by fever. By 8:00am, chills subsided, but had body aches and headache the rest of the day and though the night. Ended by 8:00am on April 3.

Other Meds: Atorvastatin, Allopurinol, Levothyroxine

Current Illness:

ID: 1165602
Sex: M
Age: 34
State:

Vax Date: 04/02/2021
Onset Date: 04/03/2021
Rec V Date: 04/04/2021
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: Fever of 100.2 starting morning after vaccination. Body aches, chills, fatigue.

Other Meds:

Current Illness:

ID: 1165603
Sex: F
Age:
State: KS

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

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

Lab Data:

Allergies:

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: body aches; nausea; headache; fever; chills; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EK9231), via an unspecified route of administration on 08Jan2021 as single dose for COVID-19 immunization. The patient's medical history reported as blood pressure high. The patient previously took the first dose of bnt162b2 (Lot number: EK5730) on 18Dec2020 for COVID-19 immunization. Concomitant medication included nifedipine extended release 60 mg, one time a day for blood pressure high from 20 years and continuing. On 08Jan2021, the patient experienced body aches, nausea, headache, fever and chills. The patient was neither admitted to hospital nor received treatment for the events. The patient was fine. On 09Jan2021, the outcome of the events was recovered. Follow-up (03Feb2021): The initial case was missing the following minimum criteria: No adverse event. Upon receipt of follow-up information on (03Feb2021), this case now contains all required information to be considered valid. This is a follow-up spontaneous report received from a contactable consumer in response to Non-HCP letter sent that included: events, suspect product details and relevant medical history.

Other Meds: NIFEDIPINE

Current Illness:

ID: 1165604
Sex: F
Age:
State: MD

Vax Date: 01/22/2021
Onset Date: 01/22/2021
Rec V Date: 04/04/2021
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: fogginess; tiredness; dizzy feeling. lasted 24 hours.; chills at night; cloudy minded. started approximately 2 hours after shot; sore arm for 24 hours as well; numbness in top of hand and thumb and pointer finger; This is a spontaneous report from a contactable consumer, the patient. A 66-year-old female patient (not pregnant) received first dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot Number: EL9262), via an unspecified route of administration, on Arm Left on 22Jan2021 at 12:15 as a single dose for COVID-19 immunization. Medical history included coronary artery disease, cough, back issues, arthritis and multiple allergies (from an unknown date and unknown if ongoing). Patient had allergies to medications, food, or other products. Concomitant medications included levothyroxine (Levothyroxine), clopidogrel bisulfate (Plavix), dexlansoprazole (Dexilant), metoclopramide hydrochloride (Metoperon) and pravastatin (Pravastatin). All medications were received within 2 weeks of vaccination. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications were taken for an unspecified indication, start and stop date were not reported. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. On 22Jan2021, immediately after vaccine, warmth radiating down left arm followed by numbness in top of hand and thumb and pointer finger. Lasted several hours. Approximately 2 hours after shot), the patient experienced chills at night and cloudy minded. At 14:00 patient had fogginess, tiredness and dizzy feeling. Lasted 24 hours. Patient had sore arm for 24 hours as well. No treatment was provided for events. Outcome of the events was reported as recovering.

Other Meds: LEVOTHYROXINE; PLAVIX; DEXILANT; METOPERON; PRAVASTATIN

Current Illness:

ID: 1165605
Sex: F
Age:
State: AL

Vax Date: 01/20/2021
Onset Date: 01/20/2021
Rec V Date: 04/04/2021
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: nerve damage; she didnt sleep; Fatigue; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration in left arm on 20Jan2021 at single dose for COVID-19 immunization. Medical history included acid reflux which was under control. She has been good for last 2 months. Two years ago (2019), she did have her polyps removed from uterine wall, it was done as outpatient but they still put her to sleep, but it had took her 2 weeks to get over the reaction of being put to sleep, it was the anesthesia, it wasn't pain, but she was very tired and groggy after. She has had no positive antibody or COVID test prior to the vaccine. Concomitant medication included famotidine (PEPCID) for acid reflux. The patient previously took flu vaccine. She was getting flu shot every year with no issue. She had a previous reaction to anesthesia (unspecified) which include feeling tired ang groggy. The patient had a weird, not the usual reactions, like she had read about. On 20Jan2021, she experienced fatigue, achy pain, and shoulder and joint pain. She even went to the doctor yesterday because of it. She was told she has nerve damage from the shot and a high immune response to the shot, which was a good thing, but her question was if she should take the second shot. The nerve damage started on 20Jan2021 at 10:00 that night causing shoulder pain, back pain, and lower back pain; because of it, she was not able to sleep. She only slept for 3 hours on Thursday night. She is a teacher and even had to miss school on Friday. It was just a constant dull aching pain. She was groggy. Some symptoms were typical. She never ran a fever, the pain in her shoulder went to the arms, back across to the front of the chest, she could follow it with her hand, it was achy all on the left side. She went to the doctor and said it was nerve damage. When she got the actual shot, she felt nothing, she couldn't even feel it from nurse, it did not hurt. It was not going away. The patient spoke with her friend, and her friend told her that it sounds like what she was experiencing or how she was responding was as if she has the COVID virus. Then, she was diagnosed with nerve damage by a healthcare professional. Her first dose was on 20Jan2021, the nerve damage symptoms began that same night. She was schedule for the second dose on 10Feb2021. She further reported that the symptoms were ongoing, but it was better. Her lower back pain was gone. Now, it was just localized to her shoulder, upper back, and across the chest. The patient was not taking any new medicine. She actually read to not even take TYLENOL OR ADVIL 2 days prior as it can lessen the effectiveness of the vaccine. That was why she didn't take TYLENOL until Friday afternoon on 22Jan2021. She toughed it out for 2 days. The doctor told her she could take ADVIL right now. The healthcare professional did not do any test, she really just left the office hoping that it would resolve on its own. The outcome of the event nerve damage was recovering and unknown for all other events. Follow-up attempts are completed. No further information is expected.

Other Meds: PEPCID [FAMOTIDINE]

Current Illness:

ID: 1165606
Sex: F
Age:
State: LA

Vax Date: 01/16/2021
Onset Date: 01/17/2021
Rec V Date: 04/04/2021
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: headache; This is a spontaneous report from a contactable consumer (patient). This 76-year-old female consumer (patient herself) reported that she received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL3246) via an unspecified route in Left arm on 16Jan2021 being 02:34 PM (at the age of 76-years-old) as single dose for COVID-19 immunisation. Relevant medical history and concurrent conditions included Blood pressure high started on 2009, Glaucoma, she had a car accident in 2009 where she got hit from behind that caused issues with her neck and she has this in her right eye, and her doctor put her on a new eyedrop in November, but other than that her meds stayed the same. Concomitant medications were not reported. Patient stated that her husband and her took the first dose of the vaccine on Saturday 16Jan2021. She says she was fine Saturday, then she woke up on Sunday morning with a headache behind her eyes that was not bad but she noticed it most of the day and then at night it was behind her eyes, the top of her head, and behind her head on 17Mar2021 at 07:00. She says she has had headaches all last week, and she took Advil and Tylenol which sometimes helped. She says she finally saw her doctor last Friday on the 22nd because she felt that was a long time for her to have headaches as a result of a vaccine and her doctor had her do a CAT scan to be sure, since she is 76, to check if she might be having a stroke or something. She says she has continued to have headaches, though not as bad as last week, and she was reading the material they got at the hospital because they are supposed to have the second shot 06Feb2021. She says she would like to know, have they had people report having headaches that long. She says she took both Tylenol, clarified to being Equate brand Acetaminophen, and Advil. Equate brand Ibuprofen 200mg: She says she normally doesn't take Advil. Equate brand Acetaminophen: She says she has two bottles one of which she keeps in the bedroom, so she doesn't know which bottle her doses came from. She says both of the Equate brand Acetaminophen bottles are extra strength, 500mg. She says when she took these two medications she was careful not to overtake or take too much, but she can't really tell how much she took. She says she thinks she first took one Tylenol and one Advil, then later that night when it really bothered her, she thinks she took maybe two Advil's and one Tylenol, but she didn't write it down. She says now her headache is not nearly like it was last week. She says that she spoke to her doctor on Friday because she was starting to get concerned about it, but it was not unbearable all day long, she would wake up with it then take something, and during the day it was better, then at night it would be worse. She says this week it mainly bothered her that it was at the back of her head and neck area, since she does have problems sometimes with headaches at the back of her head after she had a car accident in 2009 where she got hit from behind that caused issues with her neck. She says she doesn't have sinus issues, so the headache behind her eyes was odd, and since the information said side effect, it is too big of a coincidence that she got the shot Saturday and she had a headache on Sunday. probably in 2009, and she started taking Amlodipine 5mg then, and then after she retired from teaching her doctor decided she didn't need it and she stopped taking it. She says she has been taking again since about a year and a half ago, in 2018 at the end of the year. Amlodipine NDC/LOT/EXP: Unknown, it was dispensed in a pharmacy bottle, it says use before 14Nov2021. Laboratory tests included CT scan resulted negative on 22Jan2021. The outcome of the event was recovering.

Other Meds:

Current Illness:

ID: 1165607
Sex: M
Age:
State: IL

Vax Date: 01/27/2021
Onset Date:
Rec V Date: 04/04/2021
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: he is experiencing soreness in the arm.; This is a spontaneous report from a Pfizer sponsored program Pfizer First Connect. A contactable consumer reported for an 87-years-old male patient (husband) received first dose of BNT162B2 (solution for injection; Lot Number: EL8982) via intramuscular at left arm on 27Jan2021 12:30 PM as single dose for covid-19 immunisation. The patient medical history reported None and concomitant medications were not reported. The reporter stated that her husband received the vaccine as well he is experiencing soreness in the arm. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Therapeutic measures were taken for this event. The event considered non serious. The outcome of the event was unknown.

Other Meds:

Current Illness:

ID: 1165608
Sex: M
Age:
State: SC

Vax Date: 01/22/2021
Onset Date: 01/28/2021
Rec V Date: 04/04/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: tested positive for Covid-19; This is a spontaneous report from a contactable consumer (patient's wife). A 78-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: EL8982), via an unspecified route of administration in right arm on 22Jan2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The consumer confirmed that the patient did not received other vaccines on the same day as the COVID vaccine. The consumer reported that she and the patient were scheduled for the second dose on 12Feb2021, 3 weeks later. On 27Jan2021, the patient underwent COVID-19 PCR test, which was positive on 28Jan2021. The consumer was also tested, and her test result was negative, but they were unsure if the patient got it from her because she had a minor exposure 14 days ago. The outcome of the event was unknown. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1165609
Sex: F
Age:
State: FL

Vax Date: 01/28/2021
Onset Date: 01/28/2021
Rec V Date: 04/04/2021
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: This is a spontaneous report from a contactable consumer or other non hcp. A 75-year-old female patient received bnt162b2 (BNT162B2, solution for injection, Lot #: EL9262), dose 1 via an unspecified route of administration, administered in Arm Left on 28Jan2021 as SINGLE DOSE for covid-19 immunisation. Medical history included asthma from an unknown date and unknown if ongoing Verbatim: Asthma, hypertension from an unknown date and unknown if ongoing Verbatim: High blood pressure, blood cholesterol increased from an unknown date and unknown if ongoing Verbatim: High cholesterol, drug hypersensitivity from an unknown date and unknown if ongoing, headache from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously took halothane and experienced drug hypersensitivity, nitrous oxide and experienced drug hypersensitivity. The patient experienced constant headache on 28Jan2021. The patient underwent lab tests and procedures which included investigation: normal. The action taken in response to the event for bnt162b2 was not applicable. The outcome of the event was not recovered.

Other Meds:

Current Illness:

ID: 1165610
Sex: F
Age:
State: NY

Vax Date: 12/28/2020
Onset Date:
Rec V Date: 04/04/2021
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: arm soreness at injection site (both vaccines); This is a spontaneous report from a contactable Other HCP (patient). A 61-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number EL0140), via an Intramuscular route of administration on left arm on 28Dec2020 12:00 at single dose for Covid-19 immunization administered at Hospital. The patient medical history included hypothyroidism and hyperlipidemia. Concomitant medication in two weeks of vaccination were not reported. No Allergies to medications, food, or other products was reported. The patient reported, arm soreness at injection site on an unspecified date. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any treatment for the event. Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, the patient has been tested for COVID-19. On 25Jan2021, the patient underwent lab test SARS-CoV-2 test Nasal Swab result-negative. The outcome of event was recovered.

Other Meds:

Current Illness:

ID: 1165611
Sex: F
Age:
State: MO

Vax Date: 01/15/2021
Onset Date: 01/17/2021
Rec V Date: 04/04/2021
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: More tired feeling than usual; cough since two days after vaccine; This is a spontaneous report received from a contactable other healthcare professional. A 60-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249, expiry date: unknown), intramuscular in the right arm, on 15Jan2021 12:00, as single dose, for covid-19 immunisation, at a hospital. Medical history included HIV infection and fatigue. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 since the vaccination. Concomitant medication included bictegravir sodium, emtricitabine, tenofovir alafenamide fumarate (BIKTARVY). The patient previously took codeine and experienced allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced more tired feeling than usual and had a cough two days after the vaccine, on 17Jan2021. No treatment was received for the events. The patient was recovering from the events. The reporter assessed the events as non-serious.

Other Meds: BIKTARVY

Current Illness:

ID: 1165612
Sex: F
Age:
State: MI

Vax Date: 01/20/2021
Onset Date: 01/24/2021
Rec V Date: 04/04/2021
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: fatigue; nausea; This is a spontaneous report from a contactable nurse(patient herself). A 29-year-old female patient received the first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE solution for injection; batch/lot number and expiry date were unknown) via an unspecified route of administration in the right arm on 20Jan2021 11:00 (at the age of 29-years-old) at a single dose for covid-19 immunization in a pharmacy or drug store. Medical history included Hashimoto's disease, anxiety and depression; all of which started from an unknown date and unknown if ongoing. Concomitant medications included piroxicam (PAXIL) and bupropion hydrochloride (WELLBUTRIN), both taken for an unspecified indication and start and stop dates were not reported. The patient was not pregnant at the time of vaccination. 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 has no allergies to medications, food, or other products. On 24Jan2021 23:00, the patient experienced fatigue and nausea and reported that she has been experiencing the events since her shot. Events resulted in physician office visit. The events were reported as non-serious. It was unknown if a treatment was received for the events. The outcome of these events was not recovered. Information on the lot/batch number has been requested.

Other Meds: PAXIL; WELLBUTRIN

Current Illness:

ID: 1165613
Sex: F
Age:
State: MI

Vax Date: 01/21/2021
Onset Date: 01/23/2021
Rec V Date: 04/04/2021
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: sore and swollen arm; sore and swollen arm; This is a spontaneous report from a non-contactable consumer (patient). A 41-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number EL9261; expiration date not reported), via an unspecified route (administered on right arm) at the age of 41-years-old on 22Jan2021 06:15 AM as single dose for COVID-19 immunization. Medical history included seasonal allergy and penicillin allergy both from unknown date and unknown if ongoing. Concomitant medication included cetirizine hydrochloride (ZYRTEC) taken for an unspecified indication, start and stop date were not reported. Prior to vaccination, the patient has not been diagnosed with COVID-19 and didn't receive any other vaccines. The patient is not pregnant at the time of vaccination. The patient experienced sore and swollen arm on 23Jan2021. The events were reported as non-serious. Since the vaccination the patient has not been tested positive for COVID-19. No treatment was received for the events. The outcome of the events was not recovered/resolved. No follow-up attempts are possible. No further information is expected.

Other Meds: ZYRTEC

Current Illness:

ID: 1165614
Sex: F
Age:
State:

Vax Date: 01/28/2021
Onset Date:
Rec V Date: 04/04/2021
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: arm was sore; This is a spontaneous report from a non-contactable consumer or other non hcp (patient herself). A 58-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number, and expiration date not reported), via an unspecified route of administration on 28Jan2021 at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient's arm was sore on an unspecified date (reporter was uncertain for the event duration reported as "maybe an hour or 2"). The patient underwent lab tests and procedures which included body temperature: 97.4 degrees Fahrenheit and 97.6 degrees Fahrenheit on an unspecified date. The outcome of the event was recovered on unspecified date. No follow-up attempts are possible, information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1165615
Sex: F
Age:
State: NC

Vax Date: 01/25/2021
Onset Date: 01/27/2021
Rec V Date: 04/04/2021
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: inner ear disorder; debilitating; extreme dizziness; nausea; vomiting; stomach discomfort; slight weakness; This is a spontaneous report from a contactable consumer. A 69-years-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EN5318), via an unspecified route of administration, administered in Arm Left on 25Jan2021 13:30 (at the age of 49-years-old) at a single dose for COVID-19 immunization. Medical history included blood pressure, cholesterol and seasonal allergies. Blood pressure and cholesterol controlled by meds. Other medical history included drug hypersensitivity. The patient was known allergies to Codeine, Erythromycin, Septra, Sulfa drugs, Vicodin, Medrol. The patient's concomitant medications were not reported.. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient experienced inner ear disorder, very debilitating, extreme dizziness, nausea, vomiting on 27Jan2021 at 08:30 AM. The patient had inner ear problems before, 5 or 6 in my lifetime. She was still experiencing some stomach discomfort and a slight weakness. She had no idea if her inner ear problems this week are related to the vaccine or not. The outcome of events were recovering.

Other Meds:

Current Illness:

ID: 1165616
Sex: F
Age:
State: MO

Vax Date: 01/28/2021
Onset Date: 01/30/2021
Rec V Date: 04/04/2021
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: Muscle aches localized to right upper extremity, shoulder and neck muscles; Significant tenderness to right deltoid (injection site); This is a spontaneous report from a non-contactable health care professional (other HCP; patient herself). A 26-year-old female patient received the second dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE solution for injection; Batch/Lot Number: EL3248; Expiration date: Unknown) via an unspecified route of administration in the right arm on 28Jan2021 14:15 (at the age of 26-years-old) at a single dose for covid-19 immunization in a hospital. The patient's medical history and concomitant medications were not reported. The patient was previously vaccinated with the first dose of BNT162B2 (Batch/Lot Number: EL1284; Expiration date: Unknown) via an unspecified route of administration in the right arm on 08Jan2021 10:00 (at the age of 25-years-old) at a single dose for covid-19 immunization. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, has not been tested for COVID-19. The patient has no allergies to medications, food, or other products. On 30Jan2021 09:00, the patient experienced muscle aches localized to right upper extremity, shoulder and neck muscles and significant tenderness to right deltoid (injection site). Injection site was also reported as right arm. The events were reported as non-serious. No treatment was given for the events. The outcome of these events was recovering. No follow up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1165617
Sex: F
Age:
State: MI

Vax Date: 01/27/2021
Onset Date: 01/27/2021
Rec V Date: 04/04/2021
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: Canker Sores; Intermittent Headache; Intermittent fatigue; This is a spontaneous report from a contactable consumer (patient). A 61-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number EL3248; expiration date not reported), via an unspecified route (administered on left arm) at the age of 61-years-old on 27Jan2021 02:00 PM as single dose for COVID-19 immunization. Medical history included hypertension and sulfonamide allergy (Allergies: Sulfur-based) both from an unknown date and unknown if ongoing. The patient reported unspecified concomitant medications. Prior to vaccination, the patient has not been diagnosed with COVID-19. The patient didn't receive any other vaccines within 4 weeks prior to COVID vaccine. The patient is not pregnant at the time of vaccination. The patient experienced canker sores, intermittent headache and intermittent fatigue on 27Jan2021 16:00. The events were reported as non-serious. Since the vaccination the patient has not been tested for COVID-19. No treatment was received for the events. The outcome of the events was recovering/resolving. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1165618
Sex: F
Age:
State:

Vax Date: 01/29/2021
Onset Date: 01/01/2021
Rec V Date: 04/04/2021
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: allergic reaction; her face was itchy; swollen tongue; This is a spontaneous report from a contactable consumer (sister-in-law) via Medical Information Team. A female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 29Jan2021 as SINGLE DOSE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date in Jan2021, the patient experienced allergic reaction and described it as "her face was itchy and has a swollen tongue." The reporter assessed the events as non-serious. Therapeutic measures were taken as a result of all events which includes Benadryl. The patient was recovering from all events. Information on the lot/batch number has been requested. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1165619
Sex: M
Age:
State: OH

Vax Date: 01/21/2021
Onset Date:
Rec V Date: 04/04/2021
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: rash, very mild just itching a little bit on right arm just inside the elbow/rash on both arms; took some Benadryl, it helped him sleep; Swelling in eyes; Eyes watering a lot; eyes red, itchy, and swollen/he deduced that he was having an allergic reaction; eyes red, itchy, and swollen/he deduced that he was having an allergic reaction; eyes red, itchy, and swollen/he deduced that he was having an allergic reaction; This is a spontaneous report from a contactable consumer (patient). A 58-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 21Jan2021 (Batch/Lot Number: EL9262) as a single dose for COVID-19 immunization. Medical history included cannot see well out of right eye. There were no concomitant medications. Patient had a rash that appeared a couple days after, very mild just itching a little bit on his right arm just inside the elbow. Patient received the vaccine in the opposite arm in the left arm. Patient is going back on 11Feb2021 for the second dose. It was reported that it is better than being on a ventilator. Patient ruled out everything else the rash could have come from, he didn't change his laundry soap, or anything else. He haven't changed anything since he took the vaccine. He didn't speak to his MD about the rash, because he didn't think about it. He is going to be talking to his Doctor on Monday (unspecified date). He is going to get some calamine lotion but he took some Benadryl, it helped him sleep. It was also reported that the patient had a rash on both arms and swelling in his eyes and he went to the eye doctor who has prescribed him some medication and cream from family doctor. He noticed the rash a couple days after the vaccine and the issues with his eyes too, they were also watering a lot, can hardly see out of the right eye, he had this problem prior to vaccination. The cornea specialist prescribed him some drops, that his eyes were red, itchy, and swollen, he deduced that he was having an allergic reaction. Outcome of the event "took some Benadryl, it helped him sleep" was recovering and of the other events was not recovered. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1165620
Sex: F
Age:
State:

Vax Date: 01/21/2021
Onset Date: 01/21/2021
Rec V Date: 04/04/2021
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: Arm pain for 48 hours; Some tingling down to fingertips; This is a spontaneous report from a non-contactable consumer. A 46-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number EL8982; expiration date not reported), via an unspecified route (administered on right arm) at the age of 46-years-old on 21Jan2021 01:45 PM as single dose for COVID-19 immunization. The patient medical history was not reported. Concomitant medications included rosuvastatin calcium (CRESTOR) and levothyroxine sodium (SYNTHROID) both taken for an unspecified indication, start and stop date were not reported. Prior to vaccination, the patient has not been diagnosed with COVID-19. The patient didn't receive any other vaccines within 4 weeks prior to COVID vaccine. The patient is not pregnant at the time of vaccination. The patient has no allergies to medications, food, or other products. The patient experienced arm pain for 48 hours and some tingling down to fingertips on 21Jan2021 05:00 PM. Therapeutic measures were taken as a result of the events included ibuprofen and Tylenol. The events were reported as non-serious. Since the vaccination the patient has not been tested for COVID-19. The outcome of the events was recovered/resolved. No follow-up attempts are possible. No further information is expected.

Other Meds: CRESTOR; SYNTHROID

Current Illness:

ID: 1165621
Sex: M
Age:
State: CA

Vax Date: 01/26/2021
Onset Date: 01/28/2021
Rec V Date: 04/04/2021
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: Headache; Fever; Chills; Body aches; Dizziness; Nausea; Vomiting; This is a spontaneous report from a contactable consumer (patient). A 68-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EK9231), via an unspecified route of administration, administered in left arm on 26Jan2021 09:15 (at the age of 68-year-old) as single dose for COVID-19 immunisation. The patient medical history included GERD (Gastrooesophageal reflux disease) and shellfish allergy. 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 omeprazole, multi vitamin, fish oil and acetylsalicylic acid (BABY ASPIRIN). The patient previously took historical vaccine, first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EH9899), via an unspecified route of administration, administered in left arm on 05Jan2021 09:00 (at the age of 68-year-old) as single dose for COVID-19 immunisation. On 28Jan2021, at 02:00, the patient experienced nausea, vomiting, headache, fever, chills, body aches and dizziness. The patient did not receive any treatment for the events. The seriousness of the events was reported as non-serious. The outcome of the events was recovered on an unknown date in Jan2021.

Other Meds: OMEPRAZOLE; BABY ASPIRIN; FISH OIL

Current Illness:

ID: 1165622
Sex: M
Age:
State: TX

Vax Date: 01/19/2021
Onset Date:
Rec V Date: 04/04/2021
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: episodes of Myoclonus (jerking) that seem to have accelerated of late; episodes of Myoclonus (jerking) that seem to have accelerated of late; This is a spontaneous report from a contactable consumer or other non hcp (patient himself). A 67-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3249, batch and expiration date not reported), via an unspecified route of administration, administered on the right arm on 19Jan2021 15:00 (at the age of 67-years-old) at a single dose for COVID-19 immunisation. Medical history included degenerative disc disease, allergies to penicillin, and ongoing myoclonus. Prior to vaccination, the patient was not diagnosed with COVID-19.The patient's concomitant medications were not reported. Since the vaccination, has not been tested for COVID-19. The patient experienced episodes of myoclonus that seem to have accelerated of late on an unspecified date. Events were assessed as non-serious. Treatment was not received for the events. The outcome of the events reported was not recovered.

Other Meds:

Current Illness: Myoclonus

ID: 1165623
Sex: F
Age:
State: OR

Vax Date: 01/08/2021
Onset Date: 01/13/2021
Rec V Date: 04/04/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site swelling, Limb discomfort

Symptoms: 5 days after 1st vaccine red, 3 painful nodules to right calf and swelling to ankles bilaterally diagnosed as Erythema Nordosum; 5 days after 1st vaccine red, 3 painful nodules to right calf and swelling to ankles bilaterally diagnosed as Erythema Nordosum; This is a spontaneous report from a contactable nurse or other health care professional. A 56-years-old non pregnant female patient received first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Lot Number: EL 1283) via an unspecified route of administration in Arm Left on 08Jan2021 02:30 as single dose for covid-19 immunisation. Medical history included migraine and headaches. Concomitant medication included Nortriptyline 30 mg q (Every) hs (Night); Prozac 20 mg in am; Rel. On 13Jan2021 at 10:00, 5 days after 1st vaccinethe patient experienced 3 painful nodules to right calf and swelling to ankles bilaterally diagnosed as Erythema Nordosum. Therapeutic measures were taken as a result of 5 days after 1st vaccine red, 3 painful nodules to right calf and swelling to ankles bilaterally diagnosed as erythema nordosum (joint swelling), 5 days after 1st vaccine red, 3 painful nodules to right calf and swelling to ankles bilaterally diagnosed as erythema nordosum (erythema nodosum). The patient received the treatment with ibuprofen 600 mg TID (Three times a day). The outcome of the events was not resolved.

Other Meds: NORTRIPTYLINE; PROZAC

Current Illness:

ID: 1165624
Sex: F
Age:
State: WI

Vax Date: 01/25/2021
Onset Date: 01/27/2021
Rec V Date: 04/04/2021
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: Chills, Diarrhoea, Fatigue, Feeling abnormal, Headache

Symptoms: Had heartbeat irregularity; This is a spontaneous report from a Pfizer-sponsored program . An unspecified age of female patient received first dose of bnt162b2 (BNT162B2; Solution for injection) via unspecified route of administration on 25Jan2021 at single dose for covid-19 immunization. Relevant medical history and concomitant medications were not provided. It was reported that on 25Jan had her first dose of the vaccine then had heartbeat irregularity yesterday and today, also taking amlodipine regularly. The outcome of the event was "Unknown". Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1165625
Sex: F
Age:
State: IN

Vax Date: 01/28/2021
Onset Date: 02/01/2021
Rec V Date: 04/04/2021
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: Felt spaced out/feels spacy; Tired; Achy; This is a spontaneous report from a contactable consumer. An 86-year-old female patient received first dose of bnt162b2 (BNT162B2; Solution for injection) via unspecified route of administration on Left arm on 28Jan2021 13.00 at single dose for covid-19 immunization. Relevant medical history and concomitant medications were not provided. It was reported that caller received the first dose of the Pfizer-BioNtech Covid-19 vaccine on 28Jan2021, this morning she felt spaced out, tired and achy. Caller would like to know if this normal 4 days after receiving the vaccine. From 01Feb2021 patient experienced Ongoing feeling spacy, tired and achy. Caller states she has a quick question, states she had second Pfizer vaccination last Thursday 28Jan2021, states she felt real well until today, states she feels spacy, tired, and achy. Wants to know if this is normal for four days later. States she got the vaccine in her left arm on 28Jan2021 at 1PM. Declined to provide HCP information. Does not have NDC, Lot, or Expiration Date to provide at this time. The caller was provided with a phone number of (phone ), option 3, and business hours prior to warm transfer to (name withheld), INT-#. The outcome of the event was "Not recovered". Information on the Lot/batch number has been requested.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 636,615

Page last modified: 03 October 2021 5:28pm