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: 1134886
Sex: F
Age: 43
State:

Vax Date: 02/02/2021
Onset Date: 02/02/2021
Rec V Date: 03/25/2021
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: VACCINE ERROR: DOSE GIVER OVER 6 HOURS AFTER VIAL PUNCTURED

Other Meds:

Current Illness:

ID: 1134887
Sex: F
Age: 48
State: OH

Vax Date: 03/25/2021
Onset Date: 03/25/2021
Rec V Date: 03/25/2021
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: A few minutes after receiving vaccine patient reported with itchy throat and tingling of neck and face. Previous history of anaphylaxis to bee stings. Gave 50mg Benadryl and bottle of water. Patient did not want Epi-pen until absolutely necessary because she said previously it took her down for 2 days. She had us call husband and sister and asked for EMS to be called. Still declined Epi-pen. EMS took her to (hospital).

Other Meds:

Current Illness:

ID: 1134888
Sex: F
Age: 63
State: MA

Vax Date: 03/10/2021
Onset Date: 03/12/2021
Rec V Date: 03/25/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot: EL1284
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies: None

Symptom List: Chest discomfort, Dysphagia, Pain in extremity, Visual impairment

Symptoms: Achy left arm, tenderness in left armpit, pins & needles feeling in left hand, discomfort extends to left chest & shoulder blade

Other Meds: Amlodipine, Chlorthalidone, Atorvastatin, potassium supplement

Current Illness: None

ID: 1134889
Sex: F
Age: 54
State: TX

Vax Date: 03/20/2021
Onset Date: 03/20/2021
Rec V Date: 03/25/2021
Hospital:

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

Lab Data:

Allergies: None

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: The first day I had chills and fatigue about 6 hours after the shot. The next morning I woke up and the room was spinning and I had severe muscle aches. I had to call off work. I went back to bed and slept 13 hours and then felt fine.

Other Meds: Losartan/Hctz, Prozac, tramadol, tizanidine, lorazepam, zetia, zyrtec

Current Illness: None

ID: 1134890
Sex: F
Age: 29
State: NY

Vax Date: 03/24/2021
Onset Date: 03/24/2021
Rec V Date: 03/25/2021
Hospital:

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

Lab Data:

Allergies: Peanuts (throat tightening) Shellfish (throat tightening) Latex (hives)

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

Symptoms: Patient previously had an adverse reaction of throat tightness to the first dose of the Moderna covid vaccine. She had been counseled to discuss with her doctor about getting a second dose, and if cleared, to receive the second dose at a hospital facility. Patient reports that she discussed with her doctor, who advised her to wait for allergy testing, however the patient chose not to wait for the shipment and decided to proceed with receiving the second dose at the same location as the first dose. Per patient, had taken two puffs of QVAR prior to second dose vaccination. 11:30am Time of administration of second dose 11:40am Adverse reaction began. Patient reports throat tightness, lightheadedness, foggy. Denies trouble breathing, itching. Reports had breakfast. Two areas of erythema noted on her neck. No erythema on chest/trunk/arms/face/ears. 11:50pm BP 147/92, HR 91, O2 sat 99% 12:01pm Administered two tablets of 25mg diphenhydramine. 12:03pm O2 sat 99%, HR 112. Appears teary-eyed, distressed about circumstances. Lungs clear to auscultation bilaterally, no stridor or use of accessory muscles. 12:08pm Neck erythema resolving. 12:11pm O2 sat 99%, HR 92, BP 143/97. Reports throat tightness feels the same, but not worse. 12:19pm O2 sat 99%, HR 94 12:28pm Reports throat still tight, but feeling much better. Affect and appearance much improved, no acute distress, lucid and conversational. No erythema on neck/chest/trunk/arms/face/ears. 12:35pm Patient declined offer to consider EMS if throat tightness not resolving. Patient has her own epi-pen. Provided counseling on s/s of anaphylaxis, training husband on use of epi-pen. Instructed to call 911 if symptoms worsen or have difficulty breathing. 12:45pm BP 145/88, HR 89, O2 sat 99% 12:49pm Discharged home.

Other Meds: Allegra D (twice a day in morning and evening) QVAR 80mcg Adderall 15mg (twice a day in morning and lunch) Levocetirizine 5mg (at night) Fluticasone Pro 50mcg spray Fexofenadine HCl 180mg tablet Azelastine 0.1% 137mcg spray

Current Illness:

ID: 1134891
Sex: F
Age: 37
State: CA

Vax Date: 03/21/2021
Onset Date: 03/23/2021
Rec V Date: 03/25/2021
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: none

Symptom List: Chills, Confusional state, Eye inflammation, Headache, Laboratory test

Symptoms: My left underarm area is swollen and feels soft. The same consistency as a water balloon. There is some redness in my armpit as well. And the vaccination site is reddish and feels tougher than the rest of my arm or my right arm.

Other Meds: birth control; Tylenol pm at night during the following three subsequent nights post Dose 2. Then Advil once I noticed the swelling as per my physician's advice.

Current Illness: none

ID: 1134893
Sex: M
Age: 55
State: PA

Vax Date: 03/18/2021
Onset Date: 03/21/2021
Rec V Date: 03/25/2021
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: None

Symptom List: Pyrexia, White blood cell count decreased

Symptoms: Moderna COVID-19 vaccine Developed a severe rash on left side of my stomach with two blisters 1/2? diameter in size. I was sitting in the sun on my deck for about 2 hours and was wearing a shirt that covered my stomach. Rash disappeared after 3 days. Blisters are still present but look better. No medical treatment required

Other Meds: Baclofen, (10/10/10), 30 mg/day Lyrica, (200/200/200), 600 mg/day Flomax, .4 mg, 2 tablets 1x/day Urecholine, 5 mg, 2 tablets, 2x/day Valium 2 mg, 3 tablets, 1X/day Polyethylene Glycol 3350, NF (miralax), 17 grams daily Folic Acid, 400 mg

Current Illness: None

ID: 1134894
Sex: F
Age: 29
State: UT

Vax Date: 03/08/2021
Onset Date: 03/15/2021
Rec V Date: 03/25/2021
Hospital:

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

Lab Data:

Allergies: Tape and Morphine

Symptom List: Pharyngeal swelling

Symptoms: At approximately 7 days post first Moderna COVID vaccine she noticed redness, pain, swelling in her left arm at the injection site. Seen at urgent care as she did not have a PCP. They diagnosed cellulitis and put her on PO Keflex which she took. It looked better in 48 hours after starting antibiotic and looked completely resolved 7 after starting antibiotic.

Other Meds: unknown

Current Illness: none

ID: 1134895
Sex: F
Age: 44
State:

Vax Date: 02/02/2021
Onset Date: 02/02/2021
Rec V Date: 03/25/2021
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: VACCINE ERROR: DOSE GIVER OVER 6 HOURS AFTER VIAL PUNCTURED

Other Meds:

Current Illness:

ID: 1134896
Sex: F
Age: 69
State: CO

Vax Date: 02/11/2021
Onset Date: 03/03/2021
Rec V Date: 03/25/2021
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: Nsaids

Symptom List: Diarrhoea, Nasal congestion

Symptoms: 26 days after my first Moderna vaccination I developed Shingles. I talked to my sisters family and she also developed Shingles after a COVID vaccination.

Other Meds: ASA 81mg, Synthroid, Donepezil, Azathioprine, Buproprion HCL, Rosuvastatin, Duloxetine, Dexilant,Liothiprine,

Current Illness:

ID: 1134897
Sex: F
Age: 20
State:

Vax Date: 03/21/2021
Onset Date: 03/21/2021
Rec V Date: 03/25/2021
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: No adverse event, but pt received a more potent dose. Pharmacist reconstituted with 0.8ml instead of 1.8ml.

Other Meds:

Current Illness:

ID: 1134898
Sex: F
Age: 26
State: WI

Vax Date: 01/19/2021
Onset Date: 01/19/2021
Rec V Date: 03/25/2021
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: Doxycycline; amoxicillin - rashes

Symptom List: Rash, Urticaria

Symptoms: I developed a rash ten minutes after receiving the second dose. On my neck and it trailed down to chest area. They took me to Urgent Care and they gave me Benadryl and the Rash went away.

Other Meds: no

Current Illness: no

ID: 1134899
Sex: F
Age: 66
State: CT

Vax Date: 02/11/2021
Onset Date: 02/18/2021
Rec V Date: 03/25/2021
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 known allergies

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

Symptoms: 4 inch by 2 inch red, hot, itchy rash area lasting 4 days. Sinus congestion.

Other Meds: Calcium 1000mg daily Vitamin D 1000mcg daily Vitamin C 1000mg daily

Current Illness: Sty right eye, resolved with Augmentin Feb. 3, 2021

ID: 1134900
Sex: F
Age: 67
State: MA

Vax Date: 03/10/2021
Onset Date: 03/20/2021
Rec V Date: 03/25/2021
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: Only seasonal allergies & cats

Symptom List: Dyspnoea, Fatigue, Feeling abnormal, Head discomfort, Headache

Symptoms: On day 11 post shot I started to feel mildly nauseated. Next day nausea increased, as did muscle aches and pain - by early evening I had repeated bouts of uncontrollable vomiting and uncontrollable diarrhea [no cramps, no warning] that lasted most of the night. I did have a fever briefly - got all red and felt like I was on fire - but that passed pretty quickly while the rest continued. I had to stay up all night, any attempt to lie down triggered more vomiting. By 3 in the morning I was ?on empty? and by 6 am could lie down. Nausea took three more days to leave completely. Muscle pain is resolving, almost gone. I am resuming my meds [everything that went down before came right back up]. The only tummy pain was after hours of vomiting [muscle strain]. Today is the 25th and I?m still tired and a bit foggy but otherwise feel better. I had a call with my doctor about this and she said I should report it so that?s what I?m doing.

Other Meds: Atorvastatin, venlafaxine, nabumetone,, cyclobenzaprine, multivitamin, calcium, Advair, combivent

Current Illness: None

ID: 1134901
Sex: F
Age: 42
State: IL

Vax Date: 03/08/2021
Onset Date: 03/09/2021
Rec V Date: 03/25/2021
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: Penicillin/Benadryl

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

Symptoms: Inability to move within 24 hours - lasting 48+ hours Vomiting Pain in left (shot) arm radiating to left breast Rash Headache on the first day Chest pain/tightness, consistent shortness of breath, worse with exertion Brain fog Fatigue Inability to concentrate Very acute depression in the first 3-4 days after the 2nd shot

Other Meds: None

Current Illness: None

ID: 1134902
Sex: M
Age: 62
State:

Vax Date: 02/02/2021
Onset Date: 02/02/2021
Rec V Date: 03/25/2021
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: VACCINE ERROR: DOSE GIVER OVER 6 HOURS AFTER VIAL PUNCTURED

Other Meds:

Current Illness:

ID: 1135251
Sex: M
Age: 64
State: MD

Vax Date: 02/04/2014
Onset Date:
Rec V Date: 03/25/2021
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: shingles, including any and all of its sequelae; The information was received from a lawyer rand refers to a elderly male patient of unknown age. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 04-FEB-2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) in a clinic for prophylaxis (dose, route of adminstration, lot # and expiration date were not reported). The patient was 64-years-old when he received zoster vaccine live (ZOSTAVAX) (reported as 65-years-old). As a result of his receipt of zoster vaccine live (ZOSTAVAX) in 2014, patient was caused to suffer shingles, including any and all of its sequelae. As a result of his receipt of zoster vaccine live (ZOSTAVAX), patient was caused to suffer severe personal injuries, pain, suffering, and emotional distress, as well as to incur substantial economic damages. As a result of the foregoing acts and omissions, the patient was caused to suffer serious and dangerous side effects including shingles as well as other severe and personal injuries which are permanent and lasting in nature, physical pain and mental anguish, including diminished enjoyment of life, as well as the need for lifelong medical treatment, monitoring and/or medications. As a result of the foregoing acts and omissions, the patient requires and/or will require more health care and services and did incur medical, health, he will int the future be required to obtain further medical and/or hospital care, attention and services. Patient also has suffered diminished capacity for the enjoyment of life, a diminished quality of life, increased risk of premature death, aggravation of preexisting conditions, activation of latent conditions, and other loses and damages. The reporter considered shingles to be related to zoster vaccine live (ZOSTAVAX).

Other Meds:

Current Illness:

ID: 1135255
Sex: F
Age:
State: CA

Vax Date: 02/22/2021
Onset Date: 02/22/2021
Rec V Date: 03/25/2021
Hospital: Y

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

Lab Data:

Allergies:

Symptom List: Ear pain, Hypoaesthesia

Symptoms: GI bleed; received dose 2 on 22Feb2021 10:15; received dose 2 on 22Feb2021 10:15; This is a spontaneous report from a contactable consumer. A 73-year-old female non-pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 22Feb2021 10:15 at 73-year-old (Lot Number: EN6201) as single dose for covid-19 immunization; apixaban (ELIQUIS), via an unspecified route of administration from 22Feb2021 06:00 (Batch/Lot number was not reported), at unspecified dose for cerebrovascular accident prophylaxis. Facility type vaccine was hospital. Medical history included atrial fibrillation and diverticulum. No covid prior vaccination. No known allergies. The patient's concomitant medications were not reported. The patient previous received the first dose of the vaccine (lot number: EN5318) on 05Feb2021 12:00 at Left arm for covid-19 immunization. No other vaccine in four weeks. At 11:45 am (an hour and a half later) on 22Feb2021. The patient was admitted to the hospital via the Emergency room for a gastrointestinal bleed. The patient had taken the Eliquis at 6 am that morning. The patient was hospitalized for GI bleed from 22Feb2021 to 26Feb2021 for 4 days. The patient underwent lab tests and procedures which included Nasal Swab sars-cov-2 test: negative on 22Feb2021. The action taken in response to the event for apixaban was unknown. The outcome of the event GI bleed was recovered. Treatment of Kcentra Infusion and 2 units of blood transfusion received. Additional information received by Pfizer from Bristol-Myers Squibb (manufacturer control number: US-BRISTOL-MYERS SQUIBB COMPANY-BMS-2021-026613), license party for apixaban also included: BMS's assessment (event GI bleed was serious).; Sender's Comments: This patient had developed gastrointestinal haemorrhage after receiving apixaban therapy. Based on the anticoagulant nature of apixaban, its role in the bleeding event is considered possible.

Other Meds: Eliquis.

Current Illness:

ID: 1135262
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 03/25/2021
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: had his shots and got shingles a year later/Suspected vaccination failure; had his shots and got shingles a year later; This case was reported by a consumer and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, 1 year after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. Additional details were provided as follows: The reporter was the patient's wife. The age at vaccination was not reported. The reporter stated that, her husband had shingles a year later administration of shingles shots. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization for shingles and laboratory confirmation for shingles were not provided.

Other Meds:

Current Illness:

ID: 1135263
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 03/25/2021
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: This case was reported by a consumer via interactive digital media and described the occurrence of paralysis of arms in a male patient who received Herpes zoster (Shingle's vaccine). On an unknown date, the patient received Shingle's vaccine. On an unknown date, unknown after receiving Shingle's vaccine, the patient experienced paralysis of arms (serious criteria disability and GSK medically significant), anxiety and activities of daily living impaired. On an unknown date, the outcome of the paralysis of arms was recovered/resolved and the outcome of the anxiety and activities of daily living impaired were unknown. It was unknown if the reporter considered the paralysis of arms, anxiety and activities of daily living impaired to be related to Shingle's vaccine. Additional details were provided as follows: The reporter was the patient's wife. The age at vaccination was not reported. The reporter stated that, after shingles shot, her husband's arm paralyzed for over a week, and it was frightening. The reporter had to help the patient for everything from showering to dressing to bathroom. The reporter stated that, did some research and lysine kept you from getting shingles. The reporter stated that never again would they get vaccines, or flu shots or all these crazy shots.

Other Meds:

Current Illness:

ID: 1135264
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 03/25/2021
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: took the shots a couple of months before, he came down with them/suspected vaccination failure; took the shots a couple of months before he came down with them.; This case was reported by a consumer and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine. Additional details were provided as follows: Age at vaccination was not reported. The case was reported by the patient for himself. The patient took the Shingles shots a couple of months before, he came down with them. This case was considered as suspected vaccination failure since details regarding time to onset and laboratory test confirming shingles were not provided.

Other Meds:

Current Illness:

ID: 1135265
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 03/25/2021
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: Suspected vaccination failure; I had shingles after having the vaccine / still get shingles but not as severe; This case was reported by a consumer and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. The patient's past medical history included chickenpox (as a child). On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. Additional details were reported as follows: The age at vaccination was not reported. The patient had shingles after having the vaccine and still get shingles but not as severe. This case was considered to be a suspected vaccination failure case, as the details regarding being full vaccination schedule, laboratory confirmation for shingles and exact time to onset were unknown.

Other Meds:

Current Illness:

ID: 1135267
Sex: F
Age: 82
State: CA

Vax Date: 02/01/2020
Onset Date: 03/01/2020
Rec V Date: 03/25/2021
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: Suspected vaccination failure; outbreak of Shingles; pain; rash on the back; two dses were given only one month apart / Dse #1-Feb. 2020 & Dse #2-March 2020; This case was reported by a other health professional via sales rep and described the occurrence of suspected vaccination failure in a 84-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. In March 2020, the patient received the 2nd dose of Shingrix. In February 2020, the patient received the 1st dose of Shingrix. In March 2020, unknown after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced drug dose administration interval too short. In March 2021, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pain and rash. On an unknown date, the outcome of the vaccination failure, shingles, pain, rash and drug dose administration interval too short were unknown. It was unknown if the reporter considered the vaccination failure, shingles, pain and rash to be related to Shingrix and Shingrix. Additional details were reported as follows: This case was reported by medical assistant. The age at vaccination was not reported. The patient stated to the reporter that the two doses were given only one month apart, which led to shortening of vaccination schedule. Approximately one year after receiving the 2nd doses of Shingrix, the patient experienced an outbreak of shingles and initial symptoms were pain, followed by a rash on the back. This case was considered to be a suspected vaccination failure case, as the details regarding laboratory confirmation for shingles was unknown. The reporter consented to follow up.

Other Meds:

Current Illness:

ID: 1135270
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 03/25/2021
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: suspected vaccination failure; had shingles shot then after my 2 / developed shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included COVID-19 VACCINE for prophylaxis. Concomitant products included COVID-19 VACCINE. On an unknown date, the patient received Shingles vaccine and the 2nd dose of COVID-19 VACCINE. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. Additional details were reported as follows: This case was reported by patient. The age at vaccination was not reported. The patient reported that preventing was a lie. The patient had shingles shot then after 2 COVID shots, the patient developed the shingles which the patient thought that the patient was having a heart attack. This case was considered to be a suspected vaccination failure case, as the details regarding being full vaccination schedule, laboratory confirmation for shingles and exact time to onset were unknown. It was unknown if the reporter considered the shingles to be related to Covid vaccine.

Other Meds: COVID-19 VACCINE

Current Illness:

ID: 1135271
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 03/25/2021
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: Suspected Vaccination failure/Have had the 2 shots for shingles and still have outbreaks of it!; Have had the 2 shots for shingles and still have outbreaks of it!; This case was reported by a consumer and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine. Additional details were provided as follows: The age at vaccination was not reported. The patient had the 2 shots for shingles and had outbreaks of Shingles. This case was considered as suspected vaccination failure as time to onset and laboratory confirmation test were unknown at the time of reporting.

Other Meds:

Current Illness:

ID: 1135272
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 03/25/2021
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: got the shingles after getting the vaccine./ Suspected Vaccination failure; got the shingles after getting the vaccine.; This case was reported by a consumer and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. Additional details were provided as follows: The reporter reported for himself or herself. The age at vaccination was not reported. The patient had shingles after shingles vaccine. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization for shingles, time to onset for event and laboratory confirmation for shingles were not provided.

Other Meds:

Current Illness:

ID: 1135274
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 03/25/2021
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: Suspected vaccination failure; Shingles; This case was reported by a consumer and described the occurrence of Suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. Additional details were provided as follows: The age at vaccination was not reported. The age group of patient was not reported but was captured as an adult as per vaccine indication. The patient had Shingles after vaccination. This case was considered as suspected vaccination failure as completion of primary vaccination schedule, time to onset and laboratory confirmation test were unknown at the time of reporting.

Other Meds:

Current Illness:

ID: 1135275
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 03/25/2021
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: Suspected vaccination failure/First vaccine yrs ago / 2 part vaccine / Shingles now; My body is a mess with shingles now. Buttocs and back; First vaccine yrs ago / Turned 65 / 2 part; This case was reported by a consumer and described the occurrence of Suspected vaccination failure in a 65-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and drug dose administration interval too long. On an unknown date, the outcome of the vaccination failure, shingles and drug dose administration interval too long were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine. Additional details were provided as follows: The age at vaccination was not reported for 1st dose. The patient received the 2nd dose of Shingrix later than the recommended schedule, which led to lengthening of vaccination schedule. The patient had f1st vaccine years ago and when turned to 65 years the physician pushed into getting the 2 part vaccine. The patient's body was a mess with shingles, buttocs and back. This case was considered as suspected vaccination failure as time to onset and laboratory confirmation test were unknown at the time of reporting.

Other Meds:

Current Illness:

ID: 1135280
Sex: F
Age: 83
State: NV

Vax Date: 01/25/2021
Onset Date: 01/25/2021
Rec V Date: 03/25/2021
Hospital: Y

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

Lab Data:

Allergies:

Symptom List: Headache, Heart rate increased, Injection site erythema, Injection site pain, Injection site swelling

Symptoms: severely dehydrated; cramping lower abdomen; flu like symptoms; intense vomiting; headache; fever; nausea; disoriented; cramping; A spontaneous report was received from a consumer who was also an 83-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced severe dehydration/Dehydration, cramping in lower abdomen/ abdominal pain lower, fever/pyrexia, nausea, headache, disorientation, flu like symptoms/ Influenza like illness, intense vomiting/ vomiting and cramping/ muscle spasms. Patient's medical history was not provided, and concomitant medicines were not reported. On 25 Jan 2021, the same day as the onset of symptoms, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the left arm for prophylaxis of COVID-19 infection. Patient reported that she initially had an "extreme reaction" with severe, flu-like symptoms, headache, fever, disorientation, nausea and dehydration. She reported that she had a fever within three hours of receiving the vaccination. She stated that she suffered extreme vomiting for three and a half weeks along with ongoing headache, fever and cramping. On an unknown date, she was in the hospital, or ER, where she received medication for nausea and intravenous medication for dehydration (unknown if hospitalized}. She reported eight hours of pain/cramping in her lower abdomen, and again, stated that she was severely dehydrated. (The duration of hospitalization or ER visit was not reported). At the time of reporting, she said that her symptoms were ongoing, however, much less severe. Treatment included was nausea medication (patient did not remember the drug's name), intravenous (IV) medication for dehydration, IV antibiotics and dicycloverine. Action taken with mRNA-1273 was not reported. The outcomes of the events, dehydration, cramping in lower abdomen, fever, nausea, headache, disorientation, flu like symptoms, intense vomiting and cramping, were considered recovering/resolving.; 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:

Date Died: 01/22/2021

ID: 1135281
Sex: M
Age: 57
State: AZ

Vax Date: 01/21/2021
Onset Date: 01/22/2021
Rec V Date: 03/25/2021
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: Passed away; A spontaneous report was received from a Healthcare Professional concerning a 57-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and passed away/death. The patient's medical history was not provided. However, the patient had some serious chronic health condition. No relevant concomitant medications were reported. On 21 Jan 2021, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (lot/batch: LOT: 011L20A Exp: 03July2021) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection. He did not experience any symptoms right away and nothing within the next 15 mins under observation. On 22 Jan 2021, the patient passed away. Treatment details was not reported. Action taken with mRNA-1273 in response to the event passed away, was not applicable. On 22 Jan 2021, the patient died. It was unknown if an autopsy was performed.; Reporter's Comments: Very limited information regarding the event of death has been provided at this time. Further information has been requested.; Reported Cause(s) of Death: Passed away

Other Meds:

Current Illness:

ID: 1135282
Sex: F
Age: 67
State: NC

Vax Date: 02/12/2021
Onset Date: 02/12/2021
Rec V Date: 03/25/2021
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: I had the black stool, there was blood; Stomach upset; muscle ache; Fatigue; Nausea; A spontaneous report was received from a Reporter like Consumer concerning a 67? Year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events muscle ache, had the black stool there was blood/ Haematochezia, nausea, stomach upset, fatigue were reported. The patient's medical history was not provided. No relevant concomitant medications were reported. On 12 Feb 2021, prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (lot/batch:024M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 12 Feb 2021 , The patient experienced the events muscle ache, had the black stool, there was blood , nausea, stomach upset, fatigue were reported. Event i had the black stool, there was blood was considered medically significant. Laboratory details were not provided. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of event haematochezia was unknown and for other event it was resolved on 13 Feb 2021.; Reporter'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: 1135283
Sex: M
Age: 72
State: FL

Vax Date: 01/15/2021
Onset Date: 01/15/2021
Rec V Date: 03/25/2021
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: saw a ghost while being totally awake; Arm hurt; A spontaneous report was received from a Consumer concerning a 72-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events arm hurt, saw a ghost while being totally awake. The patient's medical history was not provided. No relevant concomitant medications were reported. On 15 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot batch: 011J20A) intramuscularly for prophylaxis of COVID-19 infection. On 15 Jan 2021, the patient experienced the events arm hurt. on 17 JAN 2021 saw a ghost while being totally awake. The event saw a ghost while being totally awake was considered to be medically significant. Treatment details included For the symptoms: Acetaminophen., Other: drops for his eyes for the glaucoma., FMarasco 03Feb2021 Action taken with mRNA-1273 in response to the events was not reported. On 15 Jan 2021 the outcome of events arm hurt was resolved. On 17 Jan the outcome of events include, saw a ghost while being totally awake was not reported.; 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: Glaucoma

ID: 1135284
Sex: M
Age: 55
State: CA

Vax Date: 01/13/2021
Onset Date: 01/28/2021
Rec V Date: 03/25/2021
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: Seizure; A spontaneous report was received from a consumer concerning a 55-years-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced seizure. The patient's medical history, as provided by the reporter, included epilepsy. Concomitant medications included lamotrigine and levetiracetam. On 13 Jan 2021, prior to the onset of the event, the patient received their dose of mRNA-1273 (Batch Number: 025L20A) intramuscularly for prophylaxis of COVID-19 infection. On 28 Jan 2021, the patient experienced medically significant event, seizure and was hospitalized. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the event seizure was resolved on 28 Jan 2021.; Reporter'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: LAMOTRIGINE; LAMICTAL; LEVETIRACETAM

Current Illness: Epilepsy

ID: 1135285
Sex: M
Age: 70
State: OH

Vax Date: 02/17/2021
Onset Date: 02/18/2021
Rec V Date: 03/25/2021
Hospital: Y

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: severe vomiting for one hour non stop; A spontaneous report was received from a consumer concerning a 70 year old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and developed severe vomiting. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 17 Feb 2021, approximately 1 day prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: 006M20A) intramuscularly for prophylaxis of COVID-19 infection. On 18 Feb 2021, he had severe vomiting for 1 hour non stop. He was hospitalised on that day and received treatment for that. On 19 Feb 2021, he was discharged from hospital. Treatment information was not provided. Action taken with mRNA-1273 in response to the events was not provided. The event, vomiting, was considered resolved on 19 Feb 2021.; 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: 1135286
Sex: F
Age:
State: WI

Vax Date: 02/18/2021
Onset Date: 02/18/2021
Rec V Date: 03/25/2021
Hospital: Y

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: in and out of consciousness; blood pressure was 170/112; severe chills; UTI; A spontaneous report was received from a consumer, concerning a 98-year old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced severe chills/ chills, blood pressure was 170/112/ hypertension, was in and out of consciousness/ consciousness fluctuating, chronic heart failure/ cardiac failure chronic and urinary tract infection (UTI). The patient's medical history included were chronic heart failure and urinary tract infection. Concomitant medication included was apixaban. On 18 Feb 2021, the patient received their second of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection. On 18 Feb 2021, same day of receiving vaccine, the patient experienced severe chills, blood pressure was 170/112, and was in and out of consciousness. She was hospitalized and remained at the hospital. 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 events, were considered as unknown.; Reporter's Comments: Very limited information regarding the events has been provided at this time. However, advanced age, history of chronic heart failure and concurrent underlying urinary tract infection may remain as risk factors. Further information has been requested.

Other Meds:

Current Illness: Chronic heart failure

ID: 1135287
Sex: F
Age:
State: AL

Vax Date: 01/19/2021
Onset Date: 01/19/2021
Rec V Date: 03/25/2021
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: Light energy; Fever; Arm hurt pretty bad; Chills; Body aches; Fatigue; Passed out twice; Felt like ran over by truck; A spontaneous report was received from a consume who is a female patient who passed out twice/ loss of consciousness, felt like she was run over by truck/ feeling abnormal, fatigue, chills, body aches/ myalgia, fever/ pyrexia, arm hurt pretty bad/ pain in extremity and light energy/ asthenia. The patient's medical history was not reported. Patient's concomitant reported included Lexapro and Spironolactone. On 19 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 041l20A) intramuscularly for prophylaxis of COVID-19 infection. On 19 Jan 2021, same day of receiving vaccine, the patient passed out twice and felt like she was run over by truck. She also experienced fatigue, chills, body aches, fever and arm hurt pretty bad. On 21 Jan 2021, 2 days later, she had light energy. No treatment information was reported. Action taken with mrna-1273 in response to the events was not reported. The outcome of events was not reported.; 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 (pyrexia, pain in extremity, chills, myalgia, asthenia, fatigue, feeling abnormal) a causal relationship cannot be excluded. Very limited information regarding the event (LOC) has been provided at this time. Further information has been requested.

Other Meds: LEXAPRO; SPIRONOLACTONE

Current Illness:

ID: 1135288
Sex: M
Age: 84
State: SC

Vax Date: 02/02/2021
Onset Date: 02/08/2021
Rec V Date: 03/25/2021
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: Dizziness; A spontaneous report was received from a consumer (patient), concerning himself, an 84-years-old male patient, unknown race and ethnicity, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced dizziness. The patient's medical history included major brain surgery one year ago due to a major fall off a ladder, a blood clot in his head, seizure and a pacemaker placement several years ago. Current condition included needs cane or walker. Concomitant medications reported were levetiracetam, pantoprazole, allopurinol, apixaban, carvedilol and rosuvastatin. On 02 Feb 2021, prior to the onset of the event, the patient received first of two planned doses of mRNA-1273 (lot/batch: 012M20A), intramuscular for prophylaxis of COVID-19 infection. On 08 Feb 2021, the patient experienced dizziness that was pretty severe and needs cane and walker when standing. Patient stated that he was feeling better today on 10 Feb 2021, than past two days. Reportedly, patient was inquiring about his second dose scheduled on 02 Mar 2021. Treatment details were not provided. Action taken with mRNA-1273 in response to the event was not reported. The outcome of event, dizziness was recovering.; Reporter'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: LEVETIRACETAM; PANTOPRAZOLE; ALLOPURINOL; ELIQUIS; CARVEDILOL; ROSUVASTATIN

Current Illness: Cane user

ID: 1135289
Sex: F
Age: 45
State: PA

Vax Date: 01/19/2021
Onset Date: 02/03/2021
Rec V Date: 03/25/2021
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: bulls eye rash on same arm injected; A spontaneous report was received from a 45-years-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced bull's eye rash on same injected arm/Lyme's disease. The patient's medical history was not provided. No relevant concomitant medications were reported. On 19 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 013L20A) intramuscularly for prophylaxis of COVID-19 infection. On 02 Feb 2021, 16 days after receiving the vaccine, the patient developed a bull's eye rash on same arm of injection. On 03 Feb 2021 the patient was diagnosed with lyme's disease. The patient was prescribed a 21-day regiment of doxycycline. Action taken with mRNA-1273 in response to the events was unknown. The outcome of event(s), Lyme's disease was unknown.; Reporter's Comments: Based on the current available information and the mechanism of action of mRNA-1237 vaccine, the event of Lyme's disease is assessed as unlikely related.

Other Meds:

Current Illness:

ID: 1135290
Sex: F
Age: 63
State: CA

Vax Date: 01/26/2021
Onset Date: 02/22/2021
Rec V Date: 03/25/2021
Hospital: Y

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: Seizure; Neurologically confused; A spontaneous report was received from a consumer concerning a 63-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a seizure and was neurologically confused (confusional state). The patient's current conditions included epilepsy. Concomitant product use was not provided by the reporter. On 26-JAN-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 for prophylaxis of COVID-19 infection. On 22-FEB-2021, right before the patient was supposed to get the second dose of vaccine, she had a seizure and was hospitalized. The same day, patient was neurologically confused. The patient underwent different unknown tests including computerized tomography. On 24-FEB-2021, the patient was discharged from hospital. No treatment information was provided by the reporter. Action taken with mRNA-1273 in response to the events was unknown. The outcome of events, seizure and confusional state were resolved/recovered; Reporter's Comments: Based on reporter's causality and the prior history of epilepsy, the events are assessed as unlikely related to mRNA-1273.

Other Meds:

Current Illness: Epilepsy

ID: 1135291
Sex: M
Age: 83
State: IN

Vax Date: 02/03/2021
Onset Date: 03/04/2021
Rec V Date: 03/25/2021
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: Bell's Palsy; Felt lightheaded and dizziness; Fatigue; A spontaneous report was received from a consumer concerning an 83 year-old male patient who was administered Moderna's COVID-19 vaccine (mRNA-1273) and developed Bell's palsy, Dizziness, and Fatigue. The patient's medical history and concomitant medications were not reported. On 03-FEB-2021, prior to the onset of events, the patient received his first dose of two planned doses of mRNA-1273 (lot# unknown) intramuscularly for the prophylaxis of COVID-19 infection. On 04-MAR-2021, the patient was taken to ER and was diagnosed with a mild case of Bell's palsy. He also felt dizziness, lightheaded, and fatigue. Attending doctor at the Veterans Administration said he could take the vaccine but his primary care physician advised him to wait a week. Treatment included prednisone and valacyclovir. Action taken with mRNA-1273 in response to the events was not applicable. The outcomes of events, Bell's Palsy, Dizziness, and Fatigue, were 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:

Date Died:

ID: 1135292
Sex: M
Age:
State: NJ

Vax Date: 02/11/2021
Onset Date: 02/01/2021
Rec V Date: 03/25/2021
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: Stroke shortly after the first dose; A spontaneous report was received from a consumer concerning an 81 year old, male patient who experienced stroke shortly after the first dose (cerebrovascular accident). The patient's medical history was not provided. No relevant concomitant medications were reported. On 11 FEB 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection. It was reported that the patient experienced stroke shortly after the first dose. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the event of stroke shortly after the first dose (cerebrovascular accident) was considered unknown.; Reporter's Comments: This is a case of sudden death in a 93-year-old female subject with no medical hx reported who suffered a stroke (unspecified days) after receiving first dose of vaccine. Very limited information has been provided at this time. Further information will be pursued..

Other Meds:

Current Illness:

ID: 1135293
Sex: F
Age: 81
State: AZ

Vax Date: 03/09/2021
Onset Date: 03/10/2021
Rec V Date: 03/25/2021
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: Spasms like seizures; Fidgeting non-stop; Barring their teeth like a grimace; Low-grade fever; A spontaneous report was received on 10 Mar 2021 from a consumer concerning a 81-years old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced spasms like seizures/ seizure, fidgeting non-stop/restlessness, barring their teeth like a grimace/bruxism and low-grade fever/pyrexia. The patient's medical history included COVID-19 and severe Alzheimer's disease. Concomitant product use was not provided. On 09 Mar 2021, approximately 1 day prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (Batch number: unknown) for prophylaxis of COVID-19 infection. On 10 Mar 2021, the patient experienced low-grade fever, spasms like seizures, fidgeting non-stop and barring their teeth like a grimace. Treatment information was not provided. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the events, spasms like seizures, fidgeting non-stop, barring their teeth like a grimace, and low-grade fever, were 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: Alzheimer's disease (The patient has severe Alzheimer's.)

ID: 1135294
Sex: F
Age: 71
State: MN

Vax Date: 02/08/2021
Onset Date: 03/01/2021
Rec V Date: 03/25/2021
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: Mini stroke thing; Hot; 15-20 sec she had hard time talking; Mumbling; Fatigue; Chills; A spontaneous report was received from a consumer concerning his wife a 71-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced fatigue, hot/ feeling hot, chills and for 15-20 sec she had hard time talking/ dysarthria, mumbling/ speech disorder, like mini stroke thing/ transient ischaemic attack. The patient's medical history included high blood pressure. Concomitant medications included pill for high blood pressure. On 08 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (Batch Number: Unknown) intramuscularly in the left arm (non-dominant) for prophylaxis of COVID-19 infection. On 08 Mar 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (Batch Number: Unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 08 Mar 2021, on the same night the patient experienced felt fatigue, hot, chills and for 15-20 sec the patient had hard time talking, mumbling, like mini stroke thing a medically significant event. No treatment information was 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 outcome of the events, fatigue, hot, chills and for 15-20 sec she had hard time talking, mumbling, like mini stroke thing was not reported.; 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. The patient's medical history of high blood pressure is a risk factor for stroke and hence remains a confounder for causality. The patient did not consent for the follow up.

Other Meds:

Current Illness: Blood pressure high (Pill for high blood pressure)

ID: 1135295
Sex: M
Age: 53
State: FL

Vax Date: 03/08/2021
Onset Date: 03/09/2021
Rec V Date: 03/25/2021
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: Stomach is crampy; Muscle joints hurt; Bad headache; Chills; Threw up; Bad fever; Passed out; Loose bowels; Sweating; A spontaneous report was received from a consumer concerning a 53 years old male patient who developed passed out/loss of consciousness, diabetic/diabetes mellitus, loose bowels/diarrhoea, bad fever/pyrexia, sweating/hyperhidrosis, muscle joints hurt/myalgia, stomach is crampy/abdominal pain, bad headache/headache, threw up/vomiting and chills. The patient's medical history included diabetes and sinus infection. Products known to have been used by the patient, within two weeks prior to the event, included Metformin and sinus medication. The patient received their first of two planned doses of mRNA-1273 (Batch number: 036A21A) on 8 Mar 2021 in the left arm for prophylaxis of COVID-19 infection. On 9 Mar 2021 around 10 AM the patient started feeling bad. Patient threw up, had loose bowels, bad fever, couldn't get warm for 3 hours, was sweating, and passed out. On 10 Mar 2021 patient stated that all his muscle joints hurt, and his stomach is crampy, and has a bad headache and chills. The medically significant event is loss of consciousness. Treatment information was not provided. Action taken with mRNA-1273 in response to the event(s) was not provided. The outcome of the event(s) passed out, diabetic, loose bowels, bad fever, sweating, muscle joints hurt, stomach is crampy, bad headache, threw up and chills was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.

Other Meds: METFORMIN

Current Illness: Diabetic

ID: 1135296
Sex: M
Age: 85
State: MN

Vax Date: 03/05/2021
Onset Date:
Rec V Date: 03/25/2021
Hospital: Y

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: Heart failure; Renal failure; Acute renal failure; Cardiac dysfunction; Shortness of breath; Not producing urine; Lower extremity edema; A spontaneous report was received from a physician concerning an 85-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced shortness of breath, not producing urine, lower extremity edema, acute renal failure, cardiac dysfunction, renal failure, and heart failure. The patient's medical history, as provided by the reporter, included COVID-19 three months ago. Patient had no prior history of heart failure. No Concomitant medications were reported. On 05 Mar 2021, prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection. After four days, the patient presented at the hospital with a constellation of symptoms including shortness of breath, lower extremity edema, acute renal failure, cardiac dysfunction, not producing urine. Patient was determined to be in renal failure and heart failure. For treatment of the events the patient was admitted to the hospital. Action taken with mRNA-1273 in response to the events was not reported. The seriousness criteria for all the events was hospitalization. The outcome of the events, shortness of breath, not producing urine, lower extremity edema, acute renal failure, cardiac dysfunction, renal failure, and heart failure 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 event, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1135297
Sex: M
Age: 74
State: CA

Vax Date: 02/09/2021
Onset Date: 02/21/2021
Rec V Date: 03/25/2021
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: Acute neuropathy pain in their left foot particularly in the lateral aspect; Made walking difficult and running (which they do frequently) impossibl; Two weeks of significant discomfort; A spontaneous report was received from a Physician concerning a 64-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced acute neuropathy pain in their left foot particularly in the lateral aspect/neuropathy peripheral, made walking difficult/gait disturbance and two weeks of significant discomfort/discomfort. The patient's medical history included kidney removed because of cancer. Concomitant medications reported included vitamin d3, calcium carbonate, cyanocobalamin, calcium levomefolate and curcumin. On 9 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch Number: 024M20A) in the left arm for prophylaxis of COVID-19 infection. On 21 Feb 2021, the patient experienced medically significant event acute neuropathy pain in their left foot particularly in the lateral aspect, made walking difficult and two weeks of significant discomfort. Treatment details included paracetamol. Action taken with mRNA-1273 in response to the events was not reported. The outcome of event, acute neuropathy pain in their left foot particularly in the lateral aspect was considered resolving (gotten gradually better). The outcome of events, made walking difficult and two weeks of significant discomfort was not reported.; Reporter'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: VITAMIN D3; CALCIUM CARBONATE; VITAMIN B12 [CYANOCOBALAMIN]; METHYL FOLATE; CURCUMIN

Current Illness: Cancer (One kidney removed because of cancer)

ID: 1135298
Sex: M
Age: 31
State: KS

Vax Date: 01/26/2021
Onset Date: 01/26/2021
Rec V Date: 03/25/2021
Hospital: Y

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

Lab Data:

Allergies:

Symptom List: Back pain, Cold sweat, Headache, Nausea, Vomiting

Symptoms: blood clot; Fever; sick feeling; chills; nausea; night sweats; A spontaneous report was received from a healthcare professional concerning a 31-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced sick feeling/illness, chills, nausea, night sweats, blood clot/thrombosis, and fever/pyrexia. The patient's medical history included Cystic Fibrosis and only has half of their liver. No relevant concomitant medications were reported. On 26-JAN-2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly for prophylaxis of COVID-19 infection. On 26JAN2021, the patient began experiencing symptoms including sick feeing, chills, nausea, and night sweats. The patient had blood clot and fever on 21-FEB-2021. Patient was admitted into the hospital on 22-FEB-2021 and discharged on 26-FEB-2021. He received the following tests while in the hospital: MRI, Bone Density, and LABS. Treatment of the events included Eliquis. Action taken with mRNA-1273 in response to the events was not reported. On 25 Feb 2021 the outcome of event, fever was resolved. The outcome of events, sick feeling, chills, nausea, night sweats, blood clot were 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 event, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1135299
Sex: F
Age: 63
State: FL

Vax Date: 03/05/2021
Onset Date: 03/10/2021
Rec V Date: 03/25/2021
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: Bleeding breast; A spontaneous report was received from a consumer concerning a 63 year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced breast bleeding. The patient's medical history was not reported. No concomitant medications were reported. On 05-Mar-2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) for prophylaxis of COVID-19 infection. On 10-Mar-2021 patient experienced some blood from breast. The patient's doctor recommended an emergency mammogram. Action taken with mRNA-1273 in response to the events was unknown. The outcome events, breast bleeding, was considered unknown.; Reporter's Comments: This case concerns a 63 year-old, female patient, who experienced some blood from breast 6 days after the first dose of mRNA. The patient's doctor recommended an emergency mammogram. Very limited information regarding this event/s has been provided at this time. Further information has been requested.

Other Meds:

Current Illness:

ID: 1135300
Sex: F
Age: 79
State: NY

Vax Date: 02/25/2021
Onset Date:
Rec V Date: 03/25/2021
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: Stroke; Dizziness; Blurred Vision; Slurred speech; Felt numbness; Tiredness; A sponatenous report was received from a consumer concerning a 79 years old female patient who experienced dizziness, tiredness, slurred speech, numbness, blurred vision, stroke, very very lethargic and had tingling in face and fingers, lost speech, lost eyesight. The patient's medical history as reported by the reporter includes hypertensive, diabetic and had circulation problems. Concomitant medications taken by the patient was not provided. On 25 Feb2021, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025A21A) through intramuscular route at unspecified site for prophylaxis of COVID-19 infection. On an unknown date, patient had dizziness, tiredness (which is very unusual for patient), slurred speech numbness and blurred vision and then patient was taken to the ER and diagnosed with having stroke. She was admitted and discharged when her condition improved. As per the follow up report received, the reporter reported that patient ended up in having a stroke which was a medically significant event and she was very very lethargic and had dizziness, felt numbness and tingling in face and fingers. Patient had also lost speech, lost eyesight which was a medically significant event. Patient went to the hospital where she was diagnosed. Patient was feeling better at the time of reporting and mostly recovered but feeling weak. Patient went to hospital and treatment activities for events was unknown. Action taken with mRNA-1273 in response to the events was unknown. The outcome of events, experienced dizziness, tiredness, slurred speech, numbness, blurred vision, stroke, very very lethargic and had tingling in face and fingers was recovering/resoving and lost speech, lost eyesight was unknown.; Reporter's Comments: There is not enough information to assess the causal association between the reported events and the administration of the mRNA-1273 vaccine. Critical details such as the onset date of the event is lacking. Event is also confounded by the patient's advanced age and underlying medical conditions of hypertensive, diabetic and had circulation problems.

Other Meds:

Current Illness: Diabetes; Hypertensive

ID: 1135301
Sex: M
Age: 53
State: TN

Vax Date: 03/11/2021
Onset Date: 03/11/2021
Rec V Date: 03/25/2021
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: Patient report to have been in A-fib for three days after receiving first dose of vaccine; Throat closure; Felt like anaphylaxis; A spontaneous report was received from a consumer who was a 53-year-old, male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and who developed atrial fibrillation and an anaphylactic reaction. The patient's medical history included heart failure and allergies to butter and NSAIDS. Products known to have been used by the patient, within two weeks prior to the event, included metoprolol, diltiazem, apixaban, lisinopril and loratadine. The patient received their first of two planned doses of mRNA-1273 (Batch number: 040A21A) on 11 Mar 2021 in the left arm for prophylaxis of COVID-19 infection. On 11 Mar 2021, the patient reported that he experienced a moderate reaction; throat closure (not complete). He stated that it felt like anaphylaxis. He also reported having a numb tongue. He reported that the reaction was not immediate and that it started about four hours after the vaccine. Treatment information was not provided. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the event, atrial fibrillation, was considered recovered/resolved. The outcome of the event, anaphylactic reaction, was considered recovering/resolving.; Reporter's Comments: This case concerns a 53-year-old male who experienced a serious anaphylactic reaction with serious unexpected event of atrial fibrillation and throat closure. Event onset occurred the same day as the first dose of mRNA-1273. Treatment not reported. Atrial fibrillation resolved, and anaphylaxis 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: METOPROLOL; DILTIAZEM; APIXABAN; LISINOPRIL; LORATADINE

Current Illness: Allergic reaction to drug (allergic to NSAIDS); Allergic reaction to food; Heart failure

Total 2021 VAERS Injuries: 636,615

Page last modified: 03 October 2021 5:28pm