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: 1564192
Sex: F
Age: 70
State: MN

Vax Date: 02/08/2021
Onset Date: 02/08/2021
Rec V Date: 08/15/2021
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: Area of her tongue taste weird; Food taste weird; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 09-Mar-2021. The most recent information was received on 03-May-2021 and was forwarded to Moderna on 03-May-2021. This spontaneous case was reported by a consumer and describes the occurrence of TONGUE DISORDER (Area of her tongue taste weird) and TASTE DISORDER (Food taste weird) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010m20a) for COVID-19 immunisation. The patient's medical history was not provided. Concomitant products included LISINOPRIL, VENLAFAXINE HYDROCHLORIDE (VENLAFAXINE XR), ATORVASTATIN CALCIUM (LIPITOR) and CELECOXIB. On 08-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced TONGUE DISORDER (Area of her tongue taste weird) and TASTE DISORDER (Food taste weird). At the time of the report, TONGUE DISORDER (Area of her tongue taste weird) and TASTE DISORDER (Food taste weird) was resolving. Treatment information was not provided. Reporter did not allow further contact Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: AE outcome

Other Meds: LISINOPRIL; VENLAFAXINE XR; LIPITOR; CELECOXIB.

Current Illness:

ID: 1564193
Sex: F
Age:
State: AL

Vax Date: 02/24/2021
Onset Date:
Rec V Date: 08/15/2021
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: Pain in arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in arm ) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Pain in arm ). At the time of the report, PAIN IN EXTREMITY (Pain in arm ) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product use was not provided by the reporter. No treatment information was provided. This case was linked to MOD-2021-038512 (E2B Linked Report).; Sender's Comments: MOD-2021-038512:cluster case (Other people at work took the vaccine)

Other Meds:

Current Illness:

ID: 1564194
Sex: F
Age: 71
State: MI

Vax Date: 02/16/2021
Onset Date: 02/16/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: rash on back; rash on chest; rash on arms; very itchy; sore arm; allergies; headache; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash on back), RASH (rash on chest), RASH (rash on arms), HEADACHE (headache) and PRURITUS (very itchy) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Penicillin allergy and Drug allergy (Latuda(lurasidone),Zyprexa(olanzapine), levo-dromoran(levorphanol), halzal and adhesive tape.). On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced HEADACHE (headache). On an unknown date, the patient experienced RASH (rash on back), RASH (rash on chest), RASH (rash on arms), PRURITUS (very itchy), INJECTION SITE PAIN (sore arm) and HYPERSENSITIVITY (allergies). On 18-Feb-2021, HEADACHE (headache) had resolved. At the time of the report, RASH (rash on back), RASH (rash on chest), RASH (rash on arms), PRURITUS (very itchy), INJECTION SITE PAIN (sore arm) and HYPERSENSITIVITY (allergies) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medication were not reported. Treatment Started using cortisone cream from 10Mar2021.

Other Meds:

Current Illness: Penicillin allergy

ID: 1564195
Sex: U
Age:
State: NY

Vax Date:
Onset Date:
Rec V Date: 08/15/2021
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: A spontaneous report was received from a pharmacist concerning an elderly patient, who received the second dose of the Moderna's COVID-19 vaccine (mRNA-1273) 2 days apart. The patient's medical history was not provided. No relevant concomitant medications were reported. On an unspecified date, the patient received the first of two planned doses of mRNA-1273 (Batch Number: Unknown) for prophylaxis of COVID-19 infection. Two days later (on an unspecified date) the patient received the second dose of Moderna vaccine (Inappropriate schedule of product administration). No treatment information was provided. The patient received both scheduled doses of mRNA-1273 therefore, action taken with the drug in response to the event was not applicable. The outcome of the event was considered recovered.; Reporter's Comments: This case concerns a patient of unknown gender and age who received their second of two planned doses of mRNA-1273 (Lot unknown), reporting Inappropriate schedule of product administration without any associated adverse events.

Other Meds:

Current Illness:

ID: 1564196
Sex: F
Age: 80
State: FL

Vax Date: 01/20/2021
Onset Date: 01/21/2021
Rec V Date: 08/15/2021
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: 48 days since she received the first dose of vaccine; Sore Arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore Arm) and PRODUCT DOSE OMISSION ISSUE (48 days since she received the first dose of vaccine) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 13L20A) for COVID-19 vaccination. No Medical History information was reported. On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore Arm). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (48 days since she received the first dose of vaccine). The patient was treated with NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency. On 23-Jan-2021, PAIN IN EXTREMITY (Sore Arm) had resolved. At the time of the report, PRODUCT DOSE OMISSION ISSUE (48 days since she received the first dose of vaccine) had resolved. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medication list was not provided.

Other Meds:

Current Illness:

ID: 1564197
Sex: F
Age: 68
State: PR

Vax Date: 02/11/2021
Onset Date: 02/13/2021
Rec V Date: 08/15/2021
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: Had a feeling like "falling into the vacuum"/ They felt like they were going to die; Heart was a bit raced; Palpitations; Blood pressure elevated; Could not breathe, had like asthma; Mouth was dry, completely dry; Headache; This spontaneous case was reported by a physician and describes the occurrence of FEELING ABNORMAL (Had a feeling like "falling into the vacuum"/ They felt like they were going to die), HEART RATE INCREASED (Heart was a bit raced), PALPITATIONS (Palpitations), BLOOD PRESSURE INCREASED (Blood pressure elevated) and DYSPNOEA (Could not breathe, had like asthma) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M207) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Cancer (.) and Lymphadenectomy (Cancer removed from left arm and they got their lymph nodes removed). Concurrent medical conditions included Asthma. Concomitant products included DOXAZOSIN, ATORVASTATIN and METOPROLOL for an unknown indication. On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, the patient experienced FEELING ABNORMAL (Had a feeling like "falling into the vacuum"/ They felt like they were going to die), HEART RATE INCREASED (Heart was a bit raced), PALPITATIONS (Palpitations), BLOOD PRESSURE INCREASED (Blood pressure elevated), DYSPNOEA (Could not breathe, had like asthma), DRY MOUTH (Mouth was dry, completely dry) and HEADACHE (Headache). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. On 21-Feb-2021, FEELING ABNORMAL (Had a feeling like "falling into the vacuum"/ They felt like they were going to die), HEART RATE INCREASED (Heart was a bit raced), PALPITATIONS (Palpitations), BLOOD PRESSURE INCREASED (Blood pressure elevated), DYSPNOEA (Could not breathe, had like asthma), DRY MOUTH (Mouth was dry, completely dry) and HEADACHE (Headache) had resolved. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.

Other Meds: DOXAZOSIN; ATORVASTATIN; METOPROLOL

Current Illness: Asthma

ID: 1564198
Sex: F
Age: 57
State: TN

Vax Date: 02/18/2021
Onset Date: 02/25/2021
Rec V Date: 08/15/2021
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: Tested positive for Covid-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for Covid-19) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation. The patient's past medical history included No adverse event (no reported medical history). On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 25-Feb-2021, the patient experienced COVID-19 (Tested positive for Covid-19). At the time of the report, COVID-19 (Tested positive for Covid-19) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Feb-2021, SARS-CoV-2 test positive: positive (Positive) positive. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were reported. No laboratory details were provided. No treatment medications were reported.

Other Meds:

Current Illness:

ID: 1564199
Sex: F
Age: 59
State: TX

Vax Date: 03/06/2021
Onset Date: 03/06/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Pharyngeal swelling

Symptoms: Fever; light headedness; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) and DIZZINESS (light headedness) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Passive smoking, Bronchitis and Chronic cough. On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced DIZZINESS (light headedness). On 07-Mar-2021, the patient experienced PYREXIA (Fever). At the time of the report, PYREXIA (Fever) was resolving and DIZZINESS (light headedness) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product use was not provided by the reporter.She reported that within an hour she felt so light. Patient's mucus was cleared up from chest which patient had from chronic smoking and bronchitis. patient's chronic cough had also completely gone since the day of getting vaccine. Treatment information was not provided.

Other Meds:

Current Illness: Bronchitis; Passive smoking

ID: 1564200
Sex: F
Age:
State:

Vax Date: 03/01/2021
Onset Date:
Rec V Date: 08/15/2021
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: Ache; Fatigue/exhausted; 104 fever that lasted for 24 hours; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 09-Mar-2021. The most recent information was received on 13-Jul-2021 and was forwarded to Moderna on 13-Jul-2021. This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Ache), FATIGUE (Fatigue/exhausted) and PYREXIA (104 fever that lasted for 24 hours) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination. No Medical History information was reported. On 01-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (Ache), FATIGUE (Fatigue/exhausted) and PYREXIA (104 fever that lasted for 24 hours). At the time of the report, PAIN (Ache) and FATIGUE (Fatigue/exhausted) outcome was unknown and PYREXIA (104 fever that lasted for 24 hours) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 104 (High) 104 fever. No relevant concomitant medications were reported. It was reported that patient currently was fine, and her last shot was 4 months ago. No treatment information was reported. Action taken with mRNA-1273 in response to the events was not applicable. Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: Follow-up information received on 13-Jul-2021 and included New event (Pyrexia) was added, Description as reported for event Fatigue was updated to Fatigue/exhausted, Lab data (Body temperature) was added and details about patient second dose and event description was added in narrative.

Other Meds:

Current Illness:

ID: 1564201
Sex: F
Age:
State:

Vax Date:
Onset Date: 02/24/2021
Rec V Date: 08/15/2021
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: Pricking skin sensation; Itching; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Pricking skin sensation) and PRURITUS (Itching) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Feb-2021, the patient experienced PARAESTHESIA (Pricking skin sensation) and PRURITUS (Itching). At the time of the report, PARAESTHESIA (Pricking skin sensation) and PRURITUS (Itching) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was considered as not applicable. No treatment medication were provided. No concomitant medication were provided. .7 days ago patient had itchiness .It's a prickly itchiness.

Other Meds:

Current Illness:

ID: 1564202
Sex: F
Age: 76
State: NJ

Vax Date: 01/29/2021
Onset Date: 01/29/2021
Rec V Date: 08/15/2021
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: Really tired; Her arm hurt at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Really tired) and VACCINATION SITE PAIN (Her arm hurt at the injection site) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination. No Medical History information was reported. On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jan-2021, the patient experienced FATIGUE (Really tired) and VACCINATION SITE PAIN (Her arm hurt at the injection site). At the time of the report, FATIGUE (Really tired) and VACCINATION SITE PAIN (Her arm hurt at the injection site) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were reported. Treatment details was not provided.

Other Meds:

Current Illness:

ID: 1564203
Sex: F
Age: 62
State: FL

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

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

Lab Data:

Allergies:

Symptom List: Rash, Urticaria

Symptoms: administered in lower deltoid - pretty far from where the usual injection triangle exists; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (administered in lower deltoid - pretty far from where the usual injection triangle exists) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (administered in lower deltoid - pretty far from where the usual injection triangle exists). At the time of the report, PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (administered in lower deltoid - pretty far from where the usual injection triangle exists) 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. No relevant concomitant medications reported. No treatment information was provided.

Other Meds:

Current Illness:

ID: 1564204
Sex: U
Age: 81
State: FL

Vax Date: 03/02/2021
Onset Date: 03/08/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: swelling right eye; rash on face forehead; fever; This spontaneous case was reported by a consumer and describes the occurrence of EYE SWELLING (swelling right eye), RASH (rash on face forehead) and PYREXIA (fever) in an 81-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included No adverse event (Past medical history not provided). On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced EYE SWELLING (swelling right eye), RASH (rash on face forehead) and PYREXIA (fever). At the time of the report, EYE SWELLING (swelling right eye), RASH (rash on face forehead) and PYREXIA (fever) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications taken by the patient were not provided. Treatment activities for the event fever was done with paracetamol.

Other Meds:

Current Illness:

ID: 1564205
Sex: M
Age: 71
State: MN

Vax Date: 02/26/2021
Onset Date: 02/26/2021
Rec V Date: 08/15/2021
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: rash woke him up in the middle of the night; rash spots are itchy and red; rash spots are itchy and red; rash all over the body and it comes and goes/rash on knees, elbow, shoulder, and arms; rash on the right arm around injection site; This spontaneous case was reported by a consumer and describes the occurrence of POOR QUALITY SLEEP (rash woke him up in the middle of the night), RASH PRURITIC (rash spots are itchy and red), RASH ERYTHEMATOUS (rash spots are itchy and red), RASH (rash all over the body and it comes and goes/rash on knees, elbow, shoulder, and arms) and INJECTION SITE RASH (rash on the right arm around injection site) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. No Medical History information was reported. On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced POOR QUALITY SLEEP (rash woke him up in the middle of the night), RASH PRURITIC (rash spots are itchy and red), RASH ERYTHEMATOUS (rash spots are itchy and red), RASH (rash all over the body and it comes and goes/rash on knees, elbow, shoulder, and arms) and INJECTION SITE RASH (rash on the right arm around injection site). The patient was treated with HYDROCORTISONE (HYDROCORTISONE 1% IN ABSORBASE) at a dose of UNK dosage form and DL- LACTIC ACID (EUCERIN DERMO PURIFYER) at a dose of UNK dosage form. At the time of the report, POOR QUALITY SLEEP (rash woke him up in the middle of the night), RASH PRURITIC (rash spots are itchy and red), RASH ERYTHEMATOUS (rash spots are itchy and red), RASH (rash all over the body and it comes and goes/rash on knees, elbow, shoulder, and arms) and INJECTION SITE RASH (rash on the right arm around injection site) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were reported. No laboratory details were provided. No treatment medications were reported.

Other Meds:

Current Illness:

ID: 1564206
Sex: M
Age: 72
State: FL

Vax Date: 03/08/2021
Onset Date: 03/08/2021
Rec V Date: 08/15/2021
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: Woke up "feeling bad"; Not able to get up; Felt very sick; "Can't get around much"; Chills; Fever 102.6F; "Feels worn out"; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Woke up "feeling bad"), SLEEP PARALYSIS (Not able to get up), ILLNESS (Felt very sick), DYSPNOEA ("Can't get around much") and CHILLS (Chills) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Atrial fibrillation, Hypertension (High blood pressure) and Hyperlipidemia (High cholesterol). Concurrent medical conditions included Seasonal allergy. On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, the patient experienced FEELING ABNORMAL (Woke up "feeling bad"), SLEEP PARALYSIS (Not able to get up), ILLNESS (Felt very sick), DYSPNOEA ("Can't get around much"), CHILLS (Chills), PYREXIA (Fever 102.6F) and FATIGUE ("Feels worn out"). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (Woke up "feeling bad"), SLEEP PARALYSIS (Not able to get up), ILLNESS (Felt very sick), DYSPNOEA ("Can't get around much"), CHILLS (Chills), PYREXIA (Fever 102.6F) and FATIGUE ("Feels worn out") outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Mar-2021, Body temperature: 102.6 (Inconclusive) 102.6F. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No relevant concomitant medications were reported.

Other Meds:

Current Illness: Seasonal allergy

ID: 1564207
Sex: F
Age: 85
State: CA

Vax Date: 01/18/2021
Onset Date: 01/28/2021
Rec V Date: 08/15/2021
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: Generalized pink discoloration at the injection; Lump near the injection site; COVID Arm; Red patch on the injection upper arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOLOURATION (Generalized pink discoloration at the injection), VACCINATION SITE MASS (Lump near the injection site), RASH ERYTHEMATOUS (Red patch on the injection upper arm) and VACCINATION SITE REACTION (COVID Arm) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination. NO Medical History Information was reported. On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, the patient experienced RASH ERYTHEMATOUS (Red patch on the injection upper arm). On 31-Jan-2021, the patient experienced VACCINATION SITE DISCOLOURATION (Generalized pink discoloration at the injection), VACCINATION SITE MASS (Lump near the injection site) and VACCINATION SITE REACTION (COVID Arm). At the time of the report, VACCINATION SITE DISCOLOURATION (Generalized pink discoloration at the injection), VACCINATION SITE MASS (Lump near the injection site), RASH ERYTHEMATOUS (Red patch on the injection upper arm) and VACCINATION SITE REACTION (COVID Arm) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No relevant concomitant medications were reported. Treatment details included Ice to treat the delayed injection site reaction. Most recent FOLLOW-UP information incorporated above includes: On 18-Jun-2021:

Other Meds:

Current Illness:

ID: 1564208
Sex: F
Age: 69
State:

Vax Date: 02/23/2021
Onset Date: 02/23/2021
Rec V Date: 08/15/2021
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: Some arm soreness; Diarrhea; Vomiting; Chills; A little bit tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Some arm soreness), DIARRHOEA (Diarrhea), VOMITING (Vomiting), CHILLS (Chills) and FATIGUE (A little bit tired) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, the patient experienced PAIN IN EXTREMITY (Some arm soreness), DIARRHOEA (Diarrhea), VOMITING (Vomiting), CHILLS (Chills) and FATIGUE (A little bit tired). At the time of the report, PAIN IN EXTREMITY (Some arm soreness), DIARRHOEA (Diarrhea), VOMITING (Vomiting) and CHILLS (Chills) was resolving and FATIGUE (A little bit tired) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No relevant concomitant medications were reported. No treatment information was reported.

Other Meds:

Current Illness:

ID: 1564209
Sex: F
Age:
State: FL

Vax Date: 03/02/2021
Onset Date: 03/02/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Ear pain, Hypoaesthesia

Symptoms: Arm was slightly sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was slightly sore) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm was slightly sore). At the time of the report, PAIN IN EXTREMITY (Arm was slightly sore) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. There was no concomitant list and Treatment was unknown. This case was linked to MOD-2021-033567 .; Sender's Comments: MOD-2021-033567: Same reporter

Other Meds:

Current Illness:

ID: 1564210
Sex: F
Age:
State: MA

Vax Date: 02/04/2021
Onset Date: 03/09/2021
Rec V Date: 08/15/2021
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: Cold; Then it affected her joints; Chills; On her upper arm, she felt something warm; Very red around the area and lower and across; Felt a little itchy; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Cold), ARTHRALGIA (Then it affected her joints), VACCINATION SITE WARMTH (On her upper arm, she felt something warm), ERYTHEMA (Very red around the area and lower and across) and VACCINATION SITE PRURITUS (Felt a little itchy) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A and 026A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Rheumatoid arthritis. On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Mar-2021, the patient experienced VACCINATION SITE WARMTH (On her upper arm, she felt something warm), ERYTHEMA (Very red around the area and lower and across) and VACCINATION SITE PRURITUS (Felt a little itchy). On an unknown date, the patient experienced NASOPHARYNGITIS (Cold), ARTHRALGIA (Then it affected her joints) and CHILLS (Chills). At the time of the report, NASOPHARYNGITIS (Cold), ARTHRALGIA (Then it affected her joints), VACCINATION SITE WARMTH (On her upper arm, she felt something warm), ERYTHEMA (Very red around the area and lower and across), VACCINATION SITE PRURITUS (Felt a little itchy) and CHILLS (Chills) outcome was unknown. No relevant concomitant medications were reported No treatment information was reported.

Other Meds:

Current Illness:

ID: 1564211
Sex: F
Age: 93
State: WA

Vax Date: 03/04/2021
Onset Date: 03/04/2021
Rec V Date: 08/15/2021
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: can't eat at all; can't keep any thing down, not even water; vomiting; a bruise on her arm; Arm Hurt; This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION (a bruise on her arm), PAIN IN EXTREMITY (Arm Hurt), FEEDING DISORDER (can't eat at all), HYPOKINESIA (can't keep any thing down, not even water) and VOMITING (vomiting) in a 93-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination. No Medical History information was reported. On 04-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced CONTUSION (a bruise on her arm) and PAIN IN EXTREMITY (Arm Hurt). On 08-Mar-2021, the patient experienced FEEDING DISORDER (can't eat at all), HYPOKINESIA (can't keep any thing down, not even water) and VOMITING (vomiting). At the time of the report, CONTUSION (a bruise on her arm), PAIN IN EXTREMITY (Arm Hurt), FEEDING DISORDER (can't eat at all), HYPOKINESIA (can't keep any thing down, not even water) and VOMITING (vomiting) had resolved. Concomitant product use was not provided by the reporter. Treatment information was not provided. Reporter did not allow further contact Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Follow up received on 03-MAY-2021, contains information such as events outcome has changed.

Other Meds:

Current Illness:

ID: 1564212
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/15/2021
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: chills; fatigue; rash on lower back.; eczema; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), FATIGUE (fatigue), RASH (rash on lower back.) and ECZEMA (eczema) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CHILLS (chills), FATIGUE (fatigue), RASH (rash on lower back.) and ECZEMA (eczema). At the time of the report, CHILLS (chills), FATIGUE (fatigue), RASH (rash on lower back.) and ECZEMA (eczema) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.

Other Meds:

Current Illness:

ID: 1564213
Sex: M
Age:
State: NJ

Vax Date: 12/30/2020
Onset Date:
Rec V Date: 08/15/2021
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: Pain in left arm has returned and is more intense than the first occurrence; Received second dose in right arm and experienced more pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in left arm has returned and is more intense than the first occurrence) and VACCINATION SITE PAIN (Received second dose in right arm and experienced more pain) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination. No Medical History information was reported. On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Pain in left arm has returned and is more intense than the first occurrence) and VACCINATION SITE PAIN (Received second dose in right arm and experienced more pain). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Pain in left arm has returned and is more intense than the first occurrence) had not resolved and VACCINATION SITE PAIN (Received second dose in right arm and experienced more pain) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product use not provided. Additional treatment medications include Advil.

Other Meds:

Current Illness:

ID: 1564214
Sex: F
Age: 65
State: OH

Vax Date: 02/27/2021
Onset Date:
Rec V Date: 08/15/2021
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: Injection site scab mark that is red; Injection site itching; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE SCAB (Injection site scab mark that is red) and INJECTION SITE PRURITUS (Injection site itching) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination. The patient's past medical history included No adverse event (No Reported Medical event). Concomitant products included DIPHENHYDRAMINE for an unknown indication. On 27-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE SCAB (Injection site scab mark that is red) and INJECTION SITE PRURITUS (Injection site itching). At the time of the report, INJECTION SITE SCAB (Injection site scab mark that is red) and INJECTION SITE PRURITUS (Injection site itching) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment Information was not provided.

Other Meds: DIPHENHYDRAMINE.

Current Illness:

ID: 1564215
Sex: F
Age: 28
State: MD

Vax Date: 01/05/2021
Onset Date: 01/05/2021
Rec V Date: 08/15/2021
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: eye twitching; tired; Medication leaked down my arm; This spontaneous case was reported by a health care professional and describes the occurrence of MUSCLE TWITCHING (eye twitching), INCORRECT DOSE ADMINISTERED (Medication leaked down my arm) and FATIGUE (tired) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination. No Medical History information was reported. On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2021, the patient experienced INCORRECT DOSE ADMINISTERED (Medication leaked down my arm). On an unknown date, the patient experienced MUSCLE TWITCHING (eye twitching) and FATIGUE (tired). On 05-Jan-2021, INCORRECT DOSE ADMINISTERED (Medication leaked down my arm) had resolved. At the time of the report, MUSCLE TWITCHING (eye twitching) and FATIGUE (tired) 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. No concomitant medications were reported. No treatment medications were reported. This case was linked to MOD-2021-045238 (Patient Link).

Other Meds:

Current Illness:

ID: 1564216
Sex: F
Age: 50
State: OK

Vax Date: 03/08/2021
Onset Date: 03/08/2021
Rec V Date: 08/15/2021
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: This spontaneous case was reported by a nurse and describes the occurrence of HYPOAESTHESIA ORAL (Tip of tongue became numb/numbness of upper lip), PARAESTHESIA (Tingling in left neck), ERYTHEMA (Neck, from left to right, was red) and HYPOAESTHESIA (numbness to nose/soft palate numbness) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination. Concurrent medical conditions included Allergy to chemicals (Allergic to bleach), Allergy to insect sting (Allergic to bee sting), Adhesive tape allergy (Local skin reactions to adhesives) and Allergy (Allergic if in a closed room). On 08-Mar-2021 at 1:32 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, the patient experienced HYPOAESTHESIA ORAL (Tip of tongue became numb/numbness of upper lip) and PARAESTHESIA (Tingling in left neck). 08-Mar-2021, the patient experienced HYPOAESTHESIA (numbness to nose/soft palate numbness). On 08-Mar-2021 at 1:50 PM, the patient experienced ERYTHEMA (Neck, from left to right, was red). At the time of the report, HYPOAESTHESIA ORAL (Tip of tongue became numb/numbness of upper lip), PARAESTHESIA (Tingling in left neck), ERYTHEMA (Neck, from left to right, was red) and HYPOAESTHESIA (numbness to nose/soft palate numbness) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. No laboratory details were provided. No treatment medications were reported.

Other Meds: LEVOTHYROXINE; METOPROLOL; ZYRTEC [CETIRIZINE HYDROCHLORIDE]; ADVAIR; MULTIVITAMIN [VITAMINS NOS]

Current Illness: Adhesive tape allergy (Local skin reactions to adhesives); Allergy (Allergic if in a closed room); Allergy to chemicals (Allergic to bleach); Asthma; Bee sting hypersensitivity; Drug allergy (SSRI's); Hypothyroidism; Migraine

ID: 1564217
Sex: F
Age: 69
State: VA

Vax Date: 03/05/2021
Onset Date: 02/05/2021
Rec V Date: 08/15/2021
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: Could hardly raise her arm; stools; general malaise; flu; felt sick; chills; fever of 102F; muscle pain; joint pain; felt worn out; injection site was red; Injection site was swollen; Next day arm still sore; This spontaneous case was reported by a consumer and describes the occurrence of MOBILITY DECREASED (Could hardly raise her arm), PAIN IN EXTREMITY (Next day arm still sore), DIARRHOEA (stools), MALAISE (general malaise) and INFLUENZA (flu) in a 69-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. No Medical History information was reported. On 05-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, the patient experienced PAIN IN EXTREMITY (Next day arm still sore), VACCINATION SITE ERYTHEMA (injection site was red) and VACCINATION SITE SWELLING (Injection site was swollen). On 05-Mar-2021, the patient experienced DIARRHOEA (stools), MALAISE (general malaise), INFLUENZA (flu), ILLNESS (felt sick), CHILLS (chills), PYREXIA (fever of 102F), MYALGIA (muscle pain), ARTHRALGIA (joint pain) and FATIGUE (felt worn out). On an unknown date, the patient experienced MOBILITY DECREASED (Could hardly raise her arm). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, MOBILITY DECREASED (Could hardly raise her arm), PAIN IN EXTREMITY (Next day arm still sore), DIARRHOEA (stools), MALAISE (general malaise), INFLUENZA (flu), ILLNESS (felt sick), VACCINATION SITE ERYTHEMA (injection site was red), VACCINATION SITE SWELLING (Injection site was swollen), CHILLS (chills), PYREXIA (fever of 102F), MYALGIA (muscle pain), ARTHRALGIA (joint pain) and FATIGUE (felt worn out) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1564218
Sex: M
Age:
State: TX

Vax Date: 01/30/2021
Onset Date: 02/27/2021
Rec V Date: 08/15/2021
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: itchiness on the palms of his hands; rash developing on his neck and chest/rash around his waist.; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchiness on the palms of his hands) and RASH (rash developing on his neck and chest/rash around his waist.) in an 87-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Feb-2021, the patient experienced PRURITUS (itchiness on the palms of his hands). 27-Feb-2021, the patient experienced RASH (rash developing on his neck and chest/rash around his waist.). At the time of the report, PRURITUS (itchiness on the palms of his hands) and RASH (rash developing on his neck and chest/rash around his waist.) outcome was unknown. Action taken with mRNA-1273 in response to the event was not applicable. Reporter stated that the patient takes lots of medications but someone takes care of them for him. Patient self treated the events using cortisone cream with mild relief but stated that itchiness comes back.

Other Meds:

Current Illness:

ID: 1564219
Sex: F
Age: 16
State: NC

Vax Date: 02/25/2021
Onset Date: 02/25/2021
Rec V Date: 08/15/2021
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: 16 year old received the first shot of the Moderna Covid vaccine; A spontaneous report was received from a pharmacist regarding a 16 year old female patient who received Moderna's COVID-19 vaccine (mRNA-1273)/Product administered to patient of inappropriate age. No adverse event was reported after the administration of the vaccine. The patient's medical history was not provided. No concomitant product use was reported. On 25 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 012M20A) intramuscularly for prophylaxis of COVID-19 infection. On an unknown date, it was reported that the patient who was 16 year old received the first shot. Treatment information was not applicable. Action taken with mRNA-1273 was unknown. The outcome of the event, product administered to patient of inappropriate age, was resolved.; Reporter's Comments: This case concerns a 16-year-old female patient who received their first of two planned doses of mRNA-1273 (Lot 012M20A), reporting Product administered to patient of inappropriate age without any associated adverse events.

Other Meds:

Current Illness:

ID: 1564220
Sex: F
Age: 69
State: WA

Vax Date: 02/28/2021
Onset Date: 02/28/2021
Rec V Date: 08/15/2021
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: lost taste and smell; lost taste and smell; fever; chills with teeth chattering/chills; headache; exhausted; body aches; terrible night sweats; This spontaneous case was reported by a consumer and describes the occurrence of NIGHT SWEATS (terrible night sweats), AGEUSIA (lost taste and smell), ANOSMIA (lost taste and smell), PYREXIA (fever) and CHILLS (chills with teeth chattering/chills) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19 (lost taste and smell.) in March 2020. On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced NIGHT SWEATS (terrible night sweats), PYREXIA (fever), HEADACHE (headache), FATIGUE (exhausted) and MYALGIA (body aches). 28-Feb-2021, the patient experienced CHILLS (chills with teeth chattering/chills). On an unknown date, the patient experienced AGEUSIA (lost taste and smell) and ANOSMIA (lost taste and smell). The patient was treated with PARACETAMOL (TYLENOL EXTRA STRENGTH) ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, NIGHT SWEATS (terrible night sweats), AGEUSIA (lost taste and smell), ANOSMIA (lost taste and smell), PYREXIA (fever), CHILLS (chills with teeth chattering/chills), HEADACHE (headache), FATIGUE (exhausted) and MYALGIA (body aches) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2020, SARS-CoV-2 test: positive (Positive) Positive. In July 2020, SARS-CoV-2 antibody test: positive (Positive) Positive. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concominant medications were provided. Treatment information also included heat pads and corn bags. Most recent FOLLOW-UP information incorporated above includes: On 30-Jun-2021: Follow up received on 30 Jun 2021 included no new information.

Other Meds:

Current Illness:

ID: 1564221
Sex: U
Age: 73
State:

Vax Date: 02/24/2021
Onset Date: 02/24/2021
Rec V Date: 08/15/2021
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: hot. 6" x 3" inches; Rash full arm to elbow; Pain at injection left; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (hot. 6" x 3" inches), VACCINATION SITE RASH (Rash full arm to elbow) and VACCINATION SITE PAIN (Pain at injection left) in a 73-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A20A) for COVID-19 vaccination. No Medical History information was reported. On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced VACCINATION SITE PAIN (Pain at injection left). On 02-Mar-2021, the patient experienced VACCINATION SITE WARMTH (hot. 6" x 3" inches) and VACCINATION SITE RASH (Rash full arm to elbow). The patient was treated with LORATADINE (CLARITIN [LORATADINE]) at a dose of 1 dosage form; CORTISONE at a dose of 1 dosage form; TRIAMCINOLONE at a dose of 1 dosage form and IBUPROFEN (ADVIL [IBUPROFEN]) at a dose of 1 dosage form. On 02-Mar-2021, VACCINATION SITE PAIN (Pain at injection left) had resolved. At the time of the report, VACCINATION SITE WARMTH (hot. 6" x 3" inches) and VACCINATION SITE RASH (Rash full arm to elbow) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No relevant concomitant medications were reported. Treatment information also included ice. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1564222
Sex: M
Age: 72
State: MA

Vax Date: 03/06/2021
Onset Date:
Rec V Date: 08/15/2021
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: liver enzymes were not good; This spontaneous case was reported by a consumer and describes the occurrence of HEPATIC ENZYME ABNORMAL (liver enzymes were not good) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. Concurrent medical conditions included Diabetes and Kidney disorder. Concomitant products included INSULIN ASPART (NOVOLOG), LOSARTAN and ATORVASTATIN for an unknown indication. On 06-Mar-2021 at 4:45 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEPATIC ENZYME ABNORMAL (liver enzymes were not good). At the time of the report, HEPATIC ENZYME ABNORMAL (liver enzymes were not good) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Treatment information was unknown.

Other Meds: NOVOLOG; LOSARTAN; ATORVASTATIN

Current Illness: Diabetes; Kidney disorder

ID: 1564223
Sex: U
Age:
State: CA

Vax Date:
Onset Date:
Rec V Date: 08/15/2021
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: A spontaneous report, was received from a Non Health Professional, concerning an unknown age of patient with unknown gender age, who was administered Moderna's COVID-19 vaccine (mRNA-1273) and patients got their injections from a vial that has experienced a temperature excursion (Incorrect product storage). The patient's medical history, concomitant history, lab data was not provided by the reporter. On unknown date, the patient received their first of two planned doses of mRNA-1273 (Lot number: 028L20A) intramuscularly for prophylaxis of COVID-19 infection. On unknown date, the patient got their injections from a vial that has experienced a temperature excursion (Incorrect product storage). The Action taken with the second dose of mRNA-1273 in response to the event was not reported. The outcome of the events were considered as recovered.; Reporter's Comments: This report refers to a case of Product storage error for mRNA-1273, lot #028L20A with no associated AEs.

Other Meds:

Current Illness:

ID: 1564224
Sex: F
Age:
State: IL

Vax Date:
Onset Date:
Rec V Date: 08/15/2021
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: a lot of people had flu like symptoms; chills; fever of 100; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 01-Mar-2021 and was forwarded to Moderna on 01-Mar-2021. This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (a lot of people had flu like symptoms), CHILLS (chills) and PYREXIA (fever of 100) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (a lot of people had flu like symptoms), CHILLS (chills) and PYREXIA (fever of 100). At the time of the report, INFLUENZA LIKE ILLNESS (a lot of people had flu like symptoms), CHILLS (chills) and PYREXIA (fever of 100) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product use was not provided. Treatment information was not provided. This case was linked to MOD-2021-029671, MOD-2021-038923, MOD-2021-038840 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 10-Mar-2021: No specific follow-up information recorded.; Sender's Comments: MOD-2021-029671:REporter's first injection MOD-2021-038923:Reporter's second injection MOD-2021-038840:Reporter's friend

Other Meds:

Current Illness:

ID: 1564225
Sex: F
Age:
State: AL

Vax Date: 02/24/2021
Onset Date:
Rec V Date: 08/15/2021
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: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) had resolved. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication was reported. No treatment medication was reported. This case was linked to MOD-2021-038277 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 08-Jul-2021: Updated Patient demographics, and outcome of the event; Sender's Comments: MOD-2021-038277:

Other Meds:

Current Illness:

ID: 1564226
Sex: F
Age: 72
State: IL

Vax Date: 02/10/2021
Onset Date: 02/21/2021
Rec V Date: 08/15/2021
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: Vaccination site erythema; Vaccination site pruritus; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Vaccination site erythema) and VACCINATION SITE PRURITUS (Vaccination site pruritus) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination. No Medical History information was reported. On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (Vaccination site erythema) and VACCINATION SITE PRURITUS (Vaccination site pruritus). On 26-Feb-2021, VACCINATION SITE ERYTHEMA (Vaccination site erythema) and VACCINATION SITE PRURITUS (Vaccination site pruritus) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment medication were provided. No concomitant medication were provided.

Other Meds:

Current Illness:

ID: 1564227
Sex: M
Age: 63
State: NY

Vax Date: 03/07/2021
Onset Date: 03/08/2021
Rec V Date: 08/15/2021
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: Headache; Fatigue; chills; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), FATIGUE (Fatigue) and CHILLS (chills) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003A21A and 003A21A) for COVID-19 vaccination. Concurrent medical conditions included Blood pressure. Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN) and Statin drugs for an unknown indication. On 07-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, the patient experienced HEADACHE (Headache), FATIGUE (Fatigue) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. On 09-Mar-2021, HEADACHE (Headache) had resolved. At the time of the report, FATIGUE (Fatigue) and CHILLS (chills) outcome was unknown.

Other Meds: ASPIRIN; Statin drugs

Current Illness: Blood pressure

ID: 1564228
Sex: M
Age:
State: FL

Vax Date: 01/28/2021
Onset Date:
Rec V Date: 08/15/2021
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: Patient has not gotten second vaccine by day 35 from date of first dose; This spontaneous case was reported by a health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient has not gotten second vaccine by day 35 from date of first dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient has not gotten second vaccine by day 35 from date of first dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient has not gotten second vaccine by day 35 from date of first dose) had resolved. Not Provided For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Treatment and concomitant medications were not provided by reporter.; Sender's Comments: This report refers to a case of Inappropriate Schedule Of Product Administration for mRNA-1273 (Lot #: Unknown) with no associated AEs.

Other Meds:

Current Illness:

ID: 1564229
Sex: F
Age: 55
State:

Vax Date: 01/06/2021
Onset Date: 01/06/2021
Rec V Date: 08/15/2021
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: pain across the back and shoulders; pain across the back and shoulders; numbness, dizziness and loss of balance; numbness, dizziness and loss of balance; numbness, dizziness and loss of balance; very painful stabbing pain, 9/10 on the scale of pain, on the fingernails and went to the entire; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (very painful stabbing pain, 9/10 on the scale of pain, on the fingernails and went to the entire), BACK PAIN (pain across the back and shoulders) and ARTHRALGIA (pain across the back and shoulders) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A011J20A) for COVID-19 vaccination. No Medical History information was reported. On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2021, the patient experienced PAIN IN EXTREMITY (very painful stabbing pain, 9/10 on the scale of pain, on the fingernails and went to the entire). On an unknown date, the patient experienced BACK PAIN (pain across the back and shoulders) and ARTHRALGIA (pain across the back and shoulders). At the time of the report, PAIN IN EXTREMITY (very painful stabbing pain, 9/10 on the scale of pain, on the fingernails and went to the entire), BACK PAIN (pain across the back and shoulders) and ARTHRALGIA (pain across the back and shoulders) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.

Other Meds:

Current Illness:

ID: 1564230
Sex: F
Age: 81
State: KY

Vax Date: 02/02/2021
Onset Date: 03/01/2021
Rec V Date: 08/15/2021
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: rash on right hand; blisters look like they are gonna open; red places on nose; red places on hand; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (red places on nose), ERYTHEMA (red places on hand), BLISTER (blisters look like they are gonna open) and RASH (rash on right hand) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination. No medical history was provided by the reporter. Concomitant products included WARFARIN for an unknown indication. On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Mar-2021, the patient experienced ERYTHEMA (red places on hand). On 05-Mar-2021, the patient experienced ERYTHEMA (red places on nose) and BLISTER (blisters look like they are gonna open). On 09-Mar-2021, the patient experienced RASH (rash on right hand). At the time of the report, ERYTHEMA (red places on nose), ERYTHEMA (red places on hand), BLISTER (blisters look like they are gonna open) and RASH (rash on right hand) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. This case was linked to MOD-2021-138794 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 17-May-2021: concomitant medications updated, event updated, product information updated.

Other Meds: WARFARIN

Current Illness:

ID: 1564231
Sex: F
Age: 73
State: OK

Vax Date: 02/26/2021
Onset Date: 02/27/2021
Rec V Date: 08/15/2021
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: This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (felt in a Ping-Pong machine, could not walk very well, she was bouncing back and forth), ILL-DEFINED DISORDER (felt in a Ping-Pong machine, could not walk very well, she was bouncing back and forth), ASTHENIA (felt weak), CHILLS (chills) and PYREXIA (low grade fever) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced GAIT DISTURBANCE (felt in a Ping-Pong machine, could not walk very well, she was bouncing back and forth), ILL-DEFINED DISORDER (felt in a Ping-Pong machine, could not walk very well, she was bouncing back and forth), CHILLS (chills), PYREXIA (low grade fever) and VOMITING (throwing up dark yellow and it tasted terrible). On 28-Feb-2021, the patient experienced ASTHENIA (felt weak) and HEADACHE (headache). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, GAIT DISTURBANCE (felt in a Ping-Pong machine, could not walk very well, she was bouncing back and forth), ILL-DEFINED DISORDER (felt in a Ping-Pong machine, could not walk very well, she was bouncing back and forth), ASTHENIA (felt weak), CHILLS (chills), PYREXIA (low grade fever), VOMITING (throwing up dark yellow and it tasted terrible) and HEADACHE (headache) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.

Other Meds:

Current Illness:

ID: 1564232
Sex: F
Age: 45
State: MI

Vax Date: 02/08/2021
Onset Date: 03/08/2021
Rec V Date: 08/15/2021
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: Received second dose of vaccine subcutaneously; A spontaneous report was received from a nurse concerning a 45-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and it was noted that she received second dose of vaccine subcutaneously/ Incorrect route of product administration. Medical history or concomitant product use was not reported. On 08 Feb 2021, the patient received her first of the two planned doses of mRNA-1273 (batch number: 012L20A) intramuscularly for prophylaxis of COVID-19 infection. On 08 Mar 2021, the patient received her second of the two planned doses of mRNA-1273 (batch number: 010M20A) subcutaneously in the left arm. It was reported that the injection was given on the tender surface of the skin, not muscle. Treatment information was not provided. The action taken with mRNA-1273 in response to the event was not applicable since the patient took her second dose already. The outcome of the event was resolved on 08 Mar 2021.; Reporter's Comments: This report refers to a case of incorrect route of product administration for mRNA-1273, lot # 012L20A with no associated AEs.

Other Meds:

Current Illness:

ID: 1564233
Sex: M
Age: 73
State:

Vax Date: 03/01/2021
Onset Date: 03/02/2021
Rec V Date: 08/15/2021
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: Slight headaches; Fever of 100; Chills; This spontaneous case was reported by a physician and describes the occurrence of PYREXIA (Fever of 100), CHILLS (Chills) and HEADACHE (Slight headaches) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination. Concurrent medical conditions included Hypertension and Diabetes mellitus. Concomitant products included METFORMIN for Diabetes mellitus, LOSARTAN for Hypertension, PANCRELIPASE (ZENPEP) for Pancreas disorder. On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced PYREXIA (Fever of 100) and CHILLS (Chills). On an unknown date, the patient experienced HEADACHE (Slight headaches). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Symptomatic treatment, at a dose of 1 dosage form. At the time of the report, PYREXIA (Fever of 100), CHILLS (Chills) and HEADACHE (Slight headaches) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Mar-2021, Body temperature: 100 (High) 100 F. 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 information included advil.

Other Meds: LOSARTAN; METFORMIN; ZENPEP

Current Illness: Diabetes mellitus; Hypertension

ID: 1564234
Sex: M
Age: 72
State: WA

Vax Date: 02/25/2021
Onset Date: 02/27/2021
Rec V Date: 08/15/2021
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: overall itch; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (overall itch) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. No medical history was reported by the reporter. Concomitant products included BENZONATATE for an unknown indication. On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced PRURITUS (overall itch). The patient was treated with OXYMETAZOLINE HYDROCHLORIDE (CLARITIN ALLERGIC) ongoing since an unknown date at a dose of 1 dosage form. On 27-Feb-2021, PRURITUS (overall itch) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.

Other Meds: BENZONATATE

Current Illness:

ID: 1564235
Sex: F
Age: 38
State: TN

Vax Date: 02/03/2021
Onset Date: 03/04/2021
Rec V Date: 08/15/2021
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: nausea; tired; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (nausea) and FATIGUE (tired) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029A21A and 011M20A) for COVID-19 immunisation. No Medical History information was reported. On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced NAUSEA (nausea) and FATIGUE (tired). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, NAUSEA (nausea) and FATIGUE (tired) was resolving.

Other Meds:

Current Illness:

ID: 1564236
Sex: F
Age:
State: NC

Vax Date: 02/25/2021
Onset Date: 02/26/2021
Rec V Date: 08/15/2021
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: diarrhea; upset stomach; headache; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), ABDOMINAL DISCOMFORT (upset stomach) and HEADACHE (headache) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 25-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced DIARRHOEA (diarrhea), ABDOMINAL DISCOMFORT (upset stomach) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and BISMUTH SUBSALICYLATE (PEPTO-BISMOL) at an unspecified dose and frequency. At the time of the report, DIARRHOEA (diarrhea), ABDOMINAL DISCOMFORT (upset stomach) and HEADACHE (headache) outcome was unknown. Concomitant medications was reported cholesterol medication. No laboratory details were provided. No treatment medications were reported. Action taken with mRNA-1273 in response to the events was not applicable.

Other Meds:

Current Illness:

ID: 1564237
Sex: F
Age: 72
State: AZ

Vax Date: 02/15/2021
Onset Date: 03/08/2021
Rec V Date: 08/15/2021
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: Shingles; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Shingles) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination. No Medical History information was reported. On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, the patient experienced HERPES ZOSTER (Shingles). At the time of the report, HERPES ZOSTER (Shingles) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medications included blood pressure medications. Treatment medications included shingles vaccine.

Other Meds:

Current Illness:

ID: 1564238
Sex: F
Age: 79
State: NY

Vax Date: 03/06/2021
Onset Date: 03/07/2021
Rec V Date: 08/15/2021
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: experienced severe headache; soreness at the site of injection; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (experienced severe headache) and VACCINATION SITE PAIN (soreness at the site of injection) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination. No Medical History information was reported. On 06-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Mar-2021, the patient experienced HEADACHE (experienced severe headache) and VACCINATION SITE PAIN (soreness at the site of injection). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, HEADACHE (experienced severe headache) and VACCINATION SITE PAIN (soreness at the site of injection) was resolving. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported.

Other Meds:

Current Illness:

ID: 1564239
Sex: F
Age: 79
State: WA

Vax Date: 02/11/2021
Onset Date: 02/11/2021
Rec V Date: 08/15/2021
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: Vomiting; little bit of a sore arm; had no appetite; diarrhea; exhausted; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (little bit of a sore arm), DECREASED APPETITE (had no appetite), DIARRHOEA (diarrhea), FATIGUE (exhausted) and VOMITING (Vomiting) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031120A) for COVID-19 vaccination. The patient's past medical history included Cancer. Concurrent medical conditions included Hypersensitive syndrome and Blood pressure high. On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, the patient experienced PAIN IN EXTREMITY (little bit of a sore arm), DECREASED APPETITE (had no appetite), DIARRHOEA (diarrhea) and FATIGUE (exhausted). On an unknown date, the patient experienced VOMITING (Vomiting). The patient was treated with DOMPERIDONE (MOTILIUM [DOMPERIDONE]) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (little bit of a sore arm), DECREASED APPETITE (had no appetite), DIARRHOEA (diarrhea), FATIGUE (exhausted) and VOMITING (Vomiting) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medications were low dose high blood pressure medication.

Other Meds:

Current Illness: Blood pressure high; Hypersensitive syndrome

ID: 1564240
Sex: F
Age: 36
State: NC

Vax Date: 03/08/2021
Onset Date: 03/08/2021
Rec V Date: 08/15/2021
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: Breastfeeding mother; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING BREAST FEEDING (Breastfeeding mother) and PAIN IN EXTREMITY (sore arm) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination. The patient's past medical history included No adverse event (No reported medical history.). On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced MATERNAL EXPOSURE DURING BREAST FEEDING (Breastfeeding mother) and PAIN IN EXTREMITY (sore arm). At the time of the report, MATERNAL EXPOSURE DURING BREAST FEEDING (Breastfeeding mother) and PAIN IN EXTREMITY (sore arm) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Products known to have been used by the patient, within two weeks prior to the event, included birth control. Treatment information was not provided.

Other Meds:

Current Illness:

ID: 1564241
Sex: F
Age: 65
State: IN

Vax Date: 03/04/2021
Onset Date: 03/04/2021
Rec V Date: 08/15/2021
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: one minute she felt okay and then she felt bad again; hurting; rash on her arm; fells like fever on it; hurting arm; 101 ?F fever; couldn't sleep; itching on arm; SORE MUSCLE; body aches; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (couldn't sleep), PRURITUS (itching on arm), SKIN TEMPERATURE (fells like fever on it), PAIN IN EXTREMITY (hurting arm) and FEELING ABNORMAL (one minute she felt okay and then she felt bad again) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced INSOMNIA (couldn't sleep), PRURITUS (itching on arm), MYALGIA (SORE MUSCLE) and MYALGIA (body aches). On 07-Mar-2021, the patient experienced SKIN TEMPERATURE (fells like fever on it), PAIN IN EXTREMITY (hurting arm), DISCOMFORT (hurting), RASH (rash on her arm) and PYREXIA (101 ?F fever). On an unknown date, the patient experienced FEELING ABNORMAL (one minute she felt okay and then she felt bad again). At the time of the report, INSOMNIA (couldn't sleep), PRURITUS (itching on arm), SKIN TEMPERATURE (fells like fever on it), PAIN IN EXTREMITY (hurting arm), FEELING ABNORMAL (one minute she felt okay and then she felt bad again), DISCOMFORT (hurting), RASH (rash on her arm), MYALGIA (SORE MUSCLE), MYALGIA (body aches) and PYREXIA (101 ?F fever) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment :Cortisone

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 636,615

Page last modified: 03 October 2021 5:28pm