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: 1557239
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/14/2021
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: Face Acne; Rapid heart rate; This spontaneous case was reported by a consumer and describes the occurrence of ACNE (Face Acne) and TACHYCARDIA (Rapid heart rate) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced ACNE (Face Acne) and TACHYCARDIA (Rapid heart rate). At the time of the report, ACNE (Face Acne) and TACHYCARDIA (Rapid heart rate) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No Concomitant Medications were provided By the reporter. No Treatment History was provided by the reporter. Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Follow-up information received contains non-significant information

Other Meds:

Current Illness:

ID: 1557240
Sex: M
Age: 63
State: TX

Vax Date: 02/08/2021
Onset Date: 02/15/2021
Rec V Date: 08/14/2021
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: Loss of taste; Loss of smell; Chills; Headaches; 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), AGEUSIA (Loss of taste), ANOSMIA (Loss of smell), CHILLS (Chills) and HEADACHE (Headaches) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. No Medical History information was reported. On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Feb-2021, the patient experienced COVID-19 (Tested positive for COVID-19). On an unknown date, the patient experienced AGEUSIA (Loss of taste), ANOSMIA (Loss of smell), CHILLS (Chills) and HEADACHE (Headaches). At the time of the report, COVID-19 (Tested positive for COVID-19) outcome was unknown and AGEUSIA (Loss of taste), ANOSMIA (Loss of smell), CHILLS (Chills) and HEADACHE (Headaches) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Feb-2021, SARS-CoV-2 test: positive (Positive) Tested positive for the virus with a mild case. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No relevant concomitant medications were reported. No treatment information was provided. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1557241
Sex: F
Age: 70
State: TN

Vax Date: 02/03/2021
Onset Date: 02/03/2021
Rec V Date: 08/14/2021
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: Injection site itching; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Injection site itching) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. L016M20A) for COVID-19 vaccination. The patient's past medical history included No adverse event. On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage form. On 03-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Injection site itching). At the time of the report, VACCINATION SITE PRURITUS (Injection site itching) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medication information was not provided. Treatment information was not provided.

Other Meds:

Current Illness:

ID: 1557242
Sex: F
Age: 85
State: OH

Vax Date: 01/08/2021
Onset Date: 01/08/2021
Rec V Date: 08/14/2021
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: soreness in her arm; fatigue; chills; nausea; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness in her arm), FATIGUE (fatigue), CHILLS (chills) and NAUSEA (nausea) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011L20A and 013M20A) for COVID-19 vaccination. The patient's past medical history included COVID-19 in November 2020, Cholesterol high (controlled) and Pulmonary edema (fluid in lungs). Concurrent medical conditions included Diabetic, Hypertension, Allergic reaction to antibiotics (amoxicillin), Dust allergy (and mold), Sulfonamide allergy, Drug allergy (Zestril), Drug allergy (Actos), Drug allergy (Avandia) and Drug allergy (Most statins). Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR), INSULIN LISPRO (HUMALOG), INSULIN GLARGINE (LANTUS) and FUROSEMIDE (LASIX [FUROSEMIDE]) for an unknown indication. On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Jan-2021, the patient experienced PAIN IN EXTREMITY (soreness in her arm), FATIGUE (fatigue), CHILLS (chills) and NAUSEA (nausea). At the time of the report, PAIN IN EXTREMITY (soreness in her arm), FATIGUE (fatigue), CHILLS (chills) and NAUSEA (nausea) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged. Treatment medications were not reported. Patient took second dose on 09-FEB-2021. This case was linked to MOD-2021-026890 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: No new information.

Other Meds: CRESTOR; HUMALOG; LANTUS; LASIX [FUROSEMIDE]

Current Illness: Allergic reaction to antibiotics (amoxicillin); Diabetic; Drug allergy (Zestril); Drug allergy (Most statins); Drug allergy (Avandia); Drug allergy (Actos); Dust allergy (and mold); Hypertension

ID: 1557243
Sex: M
Age: 80
State: CT

Vax Date: 01/21/2021
Onset Date: 02/23/2021
Rec V Date: 08/14/2021
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: Pink ring the size of a nickle; Rash at the injection site that extends to the elbow; Bump at the site of the injection; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (Pink ring the size of a nickle), VACCINATION SITE INDURATION (Bump at the site of the injection) and VACCINATION SITE RASH (Rash at the injection site that extends to the elbow) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023N20A and 032L20A) for COVID-19 vaccination. No medical history was provided by the reporter. Concomitant products included DIPHENHYDRAMINE and HYDROCORTISONE for an unknown indication. On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Feb-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE INDURATION (Bump at the site of the injection). On 24-Feb-2021, the patient experienced RASH ERYTHEMATOUS (Pink ring the size of a nickle) and VACCINATION SITE RASH (Rash at the injection site that extends to the elbow). At the time of the report, RASH ERYTHEMATOUS (Pink ring the size of a nickle), VACCINATION SITE INDURATION (Bump at the site of the injection) and VACCINATION SITE RASH (Rash at the injection site that extends to the elbow) outcome was unknown. No treatment information was specified Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: ollow-up information received) contains non-significant information

Other Meds: DIPHENHYDRAMINE; HYDROCORTISONE

Current Illness:

ID: 1557244
Sex: F
Age: 69
State: TN

Vax Date: 01/01/2021
Onset Date: 02/25/2021
Rec V Date: 08/14/2021
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: hot to touch (vaccination site); injection site turned darker in color; next day it was sore; redness at night, redness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (hot to touch (vaccination site)), VACCINATION SITE DISCOLOURATION (injection site turned darker in color), VACCINATION SITE ERYTHEMA (redness at night, redness at injection site) and VACCINATION SITE PAIN (next day it was sore) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011M20A and 010A21A) for COVID-19 vaccination. No relevant concomitant medications reported. No relevant medical history was reported. In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (redness at night, redness at injection site). On 26-Feb-2021, the patient experienced VACCINATION SITE WARMTH (hot to touch (vaccination site)), VACCINATION SITE DISCOLOURATION (injection site turned darker in color) and VACCINATION SITE PAIN (next day it was sore). At the time of the report, VACCINATION SITE WARMTH (hot to touch (vaccination site)), VACCINATION SITE DISCOLOURATION (injection site turned darker in color), VACCINATION SITE ERYTHEMA (redness at night, redness at injection site) and VACCINATION SITE PAIN (next day it was sore) outcome was unknown. treatment medicine include antihistamine and Tylenol This case was linked to MOD-2021-026687 (Patient Link).

Other Meds:

Current Illness:

ID: 1557245
Sex: M
Age: 77
State: OH

Vax Date: 02/23/2021
Onset Date: 02/23/2021
Rec V Date: 08/14/2021
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: Looks like a sunburn; Itchy around the injection site; Rash around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (Looks like a sunburn), VACCINATION SITE PRURITUS (Itchy around the injection site) and VACCINATION SITE RASH (Rash around the injection site) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No relevant concomitant medications reported. No relevant medical history was reported. On 23-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. On 23-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Itchy around the injection site) and VACCINATION SITE RASH (Rash around the injection site). On 01-Mar-2021, the patient experienced RASH ERYTHEMATOUS (Looks like a sunburn). At the time of the report, RASH ERYTHEMATOUS (Looks like a sunburn), VACCINATION SITE PRURITUS (Itchy around the injection site) and VACCINATION SITE RASH (Rash around the injection site) outcome was unknown. patient did not take medication as treatment. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1557246
Sex: F
Age:
State: TX

Vax Date: 01/29/2021
Onset Date: 02/07/2021
Rec V Date: 08/14/2021
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: Itching started yesterday; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching started yesterday) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination. The patient's past medical history included No adverse event (no reported medical history). Concomitant products included CURCUMIN for an unknown indication. On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Feb-2021, the patient experienced PRURITUS (Itching started yesterday). At the time of the report, PRURITUS (Itching started yesterday) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medications reported were Curcumin, some kind of compounded medication for thyroid for drug use for unknown indication. Treatment details included lotion and some kind of spray. Based on the current available information and temporal association between the use of the product and the start date of this event, a causal relationship cannot be excluded. Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of this event, a causal relationship cannot be excluded.

Other Meds: CURCUMIN

Current Illness:

ID: 1557247
Sex: F
Age: 64
State: PA

Vax Date: 02/02/2021
Onset Date: 02/02/2021
Rec V Date: 08/14/2021
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: feet felt swollen; fingers were numb and tingly; tingly; it was red and hot; its itchy; it got black and blue; sugar glucose high; no appetite; Migraine/ Headache; it was red and hot; left arm swelled up where the injection site is; irritable; achy/pain/ Hand feet pain; a little bit of palpitations; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (a little bit of palpitations), IRRITABILITY (irritable), PAIN IN EXTREMITY (achy/pain/ Hand feet pain), PERIPHERAL SWELLING (feet felt swollen) and HYPOAESTHESIA (fingers were numb and tingly) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030R20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Previously administered products included for Vaccination: flu (On left deltoid.). Concurrent medical conditions included Asthma (Asthma attack), Diabetes (For 1st shot sugar increased), Hypertension, Hypothyroidism, Diabetic neuropathy (Extreme pain in hands and feet. numb and tingle increase) and Anxiety. Concomitant products included ALPRAZOLAM (XANAX) for Anxiety, GLIPIZIDE (GLIPIZIDE XL), METFORMIN, INSULIN GLARGINE, LIXISENATIDE (SOLIQUA), DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE (FARXIGA) and LISINOPRIL for Diabetes, METOPROLOL and EZETIMIBE (ZETIA) for Hypertension, LEVOTHYROXINE for Hypothyroidism, GABAPENTIN, VITAMINS NOS (MULTIVIT [VITAMINS NOS]), VIT D [VITAMIN D NOS] and VITAMINS NOS (VIT B COMPLEXE [VITAMINS NOS]) 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 02-Feb-2021, the patient experienced PALPITATIONS (a little bit of palpitations). On 03-Feb-2021, the patient experienced IRRITABILITY (irritable) and PAIN IN EXTREMITY (achy/pain/ Hand feet pain). On an unknown date, the patient experienced PERIPHERAL SWELLING (feet felt swollen), HYPOAESTHESIA (fingers were numb and tingly), PARAESTHESIA (tingly), VACCINATION SITE WARMTH (it was red and hot), PRURITUS (its itchy), SKIN DISCOLOURATION (it got black and blue), BLOOD GLUCOSE INCREASED (sugar glucose high), DECREASED APPETITE (no appetite), MIGRAINE (Migraine/ Headache), VACCINATION SITE ERYTHEMA (it was red and hot) and VACCINATION SITE SWELLING (left arm swelled up where the injection site is). At the time of the report, PALPITATIONS (a little bit of palpitations), IRRITABILITY (irritable), PAIN IN EXTREMITY (achy/pain/ Hand feet pain), PERIPHERAL SWELLING (feet felt swollen), HYPOAESTHESIA (fingers were numb and tingly), PARAESTHESIA (tingly), VACCINATION SITE WARMTH (it was red and hot), PRURITUS (its itchy), SKIN DISCOLOURATION (it got black and blue), BLOOD GLUCOSE INCREASED (sugar glucose high), DECREASED APPETITE (no appetite), MIGRAINE (Migraine/ Headache), VACCINATION SITE ERYTHEMA (it was red and hot) and VACCINATION SITE SWELLING (left arm swelled up where the injection site is) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment information was not provided This case was linked to MOD-2021-111905. Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: Updated patient demographics, updated relevant history, updated concomitant medications, updated events outcome from unknown to recovered/resolved and updated event listedness

Other Meds: GLIPIZIDE XL; METOPROLOL; METFORMIN; SOLIQUA; XANAX; LEVOTHYROXINE; GABAPENTIN; FARXIGA; LISINOPRIL; ZETIA; MULTIVIT [VITAMINS NOS]; VIT D [VITAMIN D NOS]; VIT B COMPLEXE [VITAMINS NOS]

Current Illness: Anxiety; Asthma (Asthma attack); Diabetes (For 1st shot sugar increased); Diabetic neuropathy (Extreme pain in hands and feet. numb and tingle increase); Hypertension; Hypothyroidism

ID: 1557248
Sex: F
Age:
State: MS

Vax Date: 01/26/2021
Onset Date:
Rec V Date: 08/14/2021
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: sore arm/really sore; chills; nausea; horrible headache; whole body hurting; high temperature (100.9 was the highest; sweating; strong reaction; really sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm/really sore), CHILLS (chills), NAUSEA (nausea), HEADACHE (horrible headache) and PAIN (whole body hurting) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031C20A and 062G20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event. Concomitant products included TRAMADOL, ESTRADIOL, PANTOPRAZOLE, LEVOCETIRIZINE, MONTELUKAST, POTASSIUM, HYDROCHLOROTHIAZIDE, TRIAMTERENE (TRIAMTERENE/HYDROCHLOROTHIAZIDE) and FLUTICASONE PROPIONATE (FLONASE ALLERGY RELIEF) for an unknown indication. On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, 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 experienced PAIN IN EXTREMITY (sore arm/really sore), CHILLS (chills), NAUSEA (nausea), HEADACHE (horrible headache), PAIN (whole body hurting), PYREXIA (high temperature (100.9 was the highest), HYPERHIDROSIS (sweating), VACCINATION COMPLICATION (strong reaction) and PAIN (really sore). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (sore arm/really sore), CHILLS (chills), NAUSEA (nausea), HEADACHE (horrible headache), PAIN (whole body hurting), PYREXIA (high temperature (100.9 was the highest), HYPERHIDROSIS (sweating), VACCINATION COMPLICATION (strong reaction) and PAIN (really sore) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Pyrexia: 100.9 100.9. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. This case was linked to MOD21-039239 (Patient Link).

Other Meds: TRAMADOL; ESTRADIOL; PANTOPRAZOLE; LEVOCETIRIZINE; MONTELUKAST; POTASSIUM; TRIAMTERENE/HYDROCHLOROTHIAZIDE; FLONASE ALLERGY RELIEF

Current Illness:

ID: 1557249
Sex: F
Age: 63
State: MI

Vax Date: 01/05/2021
Onset Date: 02/25/2021
Rec V Date: 08/14/2021
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: 45 days have gone by after the first dose and the patient didn't receive her 2nd dose; 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 2nd dose 45 days after 1st dose. The patient's medical history was not provided. No relevant concomitant medications were reported. On 05 Jan 2021, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Batch Number: 011j20a) in left arm for prophylaxis of COVID-19 infection. On 25 Feb 2021, 45 days have gone by after the first dose and the patient didn't receive her 2nd dose. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not applicable. The outcome of the event patient didn't receive her 2nd dose 45 days have gone was considered recovered.; Reporter's Comments: This report refers to a case of inappropriate schedule of vaccine administered for mRNA-1273 with no associated AEs reported.

Other Meds:

Current Illness:

ID: 1557250
Sex: F
Age: 73
State: IN

Vax Date: 02/25/2021
Onset Date: 02/25/2021
Rec V Date: 08/14/2021
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: Headache; Fever of 102 F and may have went higher; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) and PYREXIA (Fever of 102 F and may have went higher) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M24A) 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) (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 25-Feb-2021, the patient experienced PYREXIA (Fever of 102 F and may have went higher). On 26-Feb-2021, the patient experienced HEADACHE (Headache). The patient was treated with IBUPROFEN at an unspecified dose and frequency. On 26-Feb-2021, PYREXIA (Fever of 102 F and may have went higher) had resolved. At the time of the report, HEADACHE (Headache) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Feb-2021, Body temperature: 102 (High) fever of 102 F.. Concomitant medications were not reported Treatment using wet cloth and ice water was reported Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Follow-up information received contains non-significant information

Other Meds:

Current Illness:

ID: 1557251
Sex: F
Age: 65
State:

Vax Date: 02/20/2021
Onset Date:
Rec V Date: 08/14/2021
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: Abdominal pain; Difficulty of breathing; Muscle pain; This spontaneous case was reported by a nurse and describes the occurrence of ABDOMINAL PAIN (Abdominal pain), DYSPNOEA (Difficulty of breathing) and MYALGIA (Muscle pain) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination. Concurrent medical conditions included Blood pressure high, Anxiety, Asthma, Allergy to antibiotic (septra ), Seafood allergy and Penicillin allergy. On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 an unknown date, the patient experienced ABDOMINAL PAIN (Abdominal pain), DYSPNOEA (Difficulty of breathing) and MYALGIA (Muscle pain). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form, qid. At the time of the report, ABDOMINAL PAIN (Abdominal pain), DYSPNOEA (Difficulty of breathing) and MYALGIA (Muscle pain) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medications included currently patient is taking medication for high blood pressure and anxiety. Treatment information included taking inhaler. Action taken with mRNA-1273 in response to the events was not Applicable.

Other Meds:

Current Illness: Allergy to antibiotic (septra); Anxiety; Asthma; Blood pressure high; Penicillin allergy; Seafood allergy

ID: 1557252
Sex: F
Age: 73
State: CT

Vax Date: 02/17/2021
Onset Date: 02/24/2021
Rec V Date: 08/14/2021
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: Injection site is red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Injection site is red) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination. Concurrent medical conditions included Hypertension and High cholesterol. On 17-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 ERYTHEMA (Injection site is red). At the time of the report, VACCINATION SITE ERYTHEMA (Injection site is red) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medication including medication for high blood pressure and cholesterol was reported. No treatment information was specified.

Other Meds:

Current Illness: High cholesterol; Hypertension

ID: 1557253
Sex: M
Age:
State: NV

Vax Date:
Onset Date:
Rec V Date: 08/14/2021
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: Shoulder pain; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Shoulder pain) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included No adverse event. 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 ARTHRALGIA (Shoulder pain). At the time of the report, ARTHRALGIA (Shoulder pain) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown. Treatment information was not provided. Concomitant information was not provided.

Other Meds:

Current Illness:

ID: 1557254
Sex: F
Age: 80
State: TX

Vax Date: 02/25/2021
Onset Date: 02/25/2021
Rec V Date: 08/14/2021
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: Fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) in an 80-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) (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 25-Feb-2021, the patient experienced PYREXIA (Fever). At the time of the report, PYREXIA (Fever) outcome was unknown. Concomitant medications were not reported No treatment information was specified

Other Meds:

Current Illness:

ID: 1557255
Sex: F
Age:
State:

Vax Date:
Onset Date: 02/25/2021
Rec V Date: 08/14/2021
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: Arm is painful; Eyes are swollen; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm is painful) and EYE SWELLING (Eyes are swollen) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included No adverse event. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 25-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm is painful) and EYE SWELLING (Eyes are swollen). At the time of the report, PAIN IN EXTREMITY (Arm is painful) and EYE SWELLING (Eyes are swollen) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown. Treatment information was not provided Concomitant information was not provided. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1557256
Sex: F
Age: 56
State:

Vax Date: 02/28/2021
Onset Date: 02/28/2021
Rec V Date: 08/14/2021
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: sore arm; heart palpatations; chest tightness; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (heart palpatations), CHEST DISCOMFORT (chest tightness) and PAIN IN EXTREMITY (sore arm) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No relevant medical history was reported. Concomitant products included LISINOPRIL, APREMILAST (OTEZLA), BUPROPION HYDROCHLORIDE (WELLBUTRIN), LORAZEPAM (ATIVAN), CEFIXIME (FLEXERIL [CEFIXIME]), PARACETAMOL (TYLENOL) and OXYCODONE HYDROCHLORIDE, OXYCODONE TEREPHTHALATE, PARACETAMOL (PERCOCET [OXYCODONE HYDROCHLORIDE;OXYCODONE TEREPHTHALATE;PARACETAMOL]) for an unknown indication. On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Feb-2021, the patient experienced PALPITATIONS (heart palpatations) and CHEST DISCOMFORT (chest tightness). On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm). On 28-Feb-2021, PALPITATIONS (heart palpatations) and CHEST DISCOMFORT (chest tightness) had resolved. At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Treatment Medications were not provided by the reporter. This case was linked to US-MODERNATX, INC.-MOD-2021-101121 (E2B Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2021-101121:

Other Meds: LISINOPRIL; OTEZLA; WELLBUTRIN; ATIVAN; FLEXERIL [CEFIXIME]; TYLENOL; PERCOCET [OXYCODONE HYDROCHLORIDE;OXYCODONE TEREPHTHALATE;PARACETAMOL]

Current Illness:

ID: 1557257
Sex: F
Age:
State: NY

Vax Date:
Onset Date:
Rec V Date: 08/14/2021
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: Chills; Fever 101?F; Headache; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), PYREXIA (Fever 101?F) and HEADACHE (Headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included No adverse event. 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 CHILLS (Chills), PYREXIA (Fever 101?F) and HEADACHE (Headache). At the time of the report, CHILLS (Chills), PYREXIA (Fever 101?F) and HEADACHE (Headache) outcome was unknown. Not Provided DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Pyrexia: 101 f 101 f. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant information was not provided. Treatment information was not provided. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1557258
Sex: M
Age: 73
State: PA

Vax Date: 02/17/2021
Onset Date: 02/17/2021
Rec V Date: 08/14/2021
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: Partial loss of taste and smell; Partial loss of taste and smell; Shortness of breath now and then; Cough now and then; Maybe post nasal drip; Sore arm; Nasty fever at night/Fever; Very tired; Mild headache; Nausea; Left arm near shoulder ached; Chills; Back pain at the waist line; Unable to sleep; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Back pain at the waist line), INSOMNIA (Unable to sleep), AGEUSIA (Partial loss of taste and smell), ANOSMIA (Partial loss of taste and smell) and DYSPNOEA (Shortness of breath now and then) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Mitral valve prolapse, Sleep apnea and Kidney stones. On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced BACK PAIN (Back pain at the waist line), INSOMNIA (Unable to sleep), PAIN IN EXTREMITY (Sore arm), PYREXIA (Nasty fever at night/Fever), FATIGUE (Very tired), HEADACHE (Mild headache), NAUSEA (Nausea), ARTHRALGIA (Left arm near shoulder ached) and CHILLS (Chills). On an unknown date, the patient experienced AGEUSIA (Partial loss of taste and smell), ANOSMIA (Partial loss of taste and smell), DYSPNOEA (Shortness of breath now and then), COUGH (Cough now and then) and UPPER-AIRWAY COUGH SYNDROME (Maybe post nasal drip). On 17-Feb-2021, PAIN IN EXTREMITY (Sore arm) and HEADACHE (Mild headache) had resolved. On 18-Feb-2021, BACK PAIN (Back pain at the waist line) had resolved. At the time of the report, INSOMNIA (Unable to sleep), AGEUSIA (Partial loss of taste and smell), ANOSMIA (Partial loss of taste and smell), DYSPNOEA (Shortness of breath now and then), COUGH (Cough now and then), UPPER-AIRWAY COUGH SYNDROME (Maybe post nasal drip), PYREXIA (Nasty fever at night/Fever), FATIGUE (Very tired), NAUSEA (Nausea), ARTHRALGIA (Left arm near shoulder ached) and CHILLS (Chills) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medication was not provided. Treatment information was not provided.

Other Meds:

Current Illness: Kidney stones; Mitral valve prolapse; Sleep apnea

ID: 1557259
Sex: F
Age: 73
State: MI

Vax Date: 02/25/2021
Onset Date: 02/25/2021
Rec V Date: 08/14/2021
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: increased frequency of urination; insomnia; chills; headache; soreness at site of injection; This spontaneous case was reported by a consumer and describes the occurrence of POLLAKIURIA (increased frequency of urination), INSOMNIA (insomnia), CHILLS (chills), HEADACHE (headache) and INJECTION SITE PAIN (soreness at site of injection) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination. No medical history provided by reporter. Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID], TRAZODONE, AMLODIPINE, VITAMINS NOS (MVI [VITAMINS NOS]) and SIMVASTATIN 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 25-Feb-2021, the patient experienced POLLAKIURIA (increased frequency of urination), INSOMNIA (insomnia), CHILLS (chills), HEADACHE (headache) and INJECTION SITE PAIN (soreness at site of injection). The patient was treated with ACETYLSALICYLIC ACID, CAFFEINE, SALICYLAMIDE (STANBACK HEADACHE) at an unspecified dose and frequency. On 26-Feb-2021, POLLAKIURIA (increased frequency of urination) had resolved. At the time of the report, INSOMNIA (insomnia), CHILLS (chills), HEADACHE (headache) and INJECTION SITE PAIN (soreness at site of injection) 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. Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Follow-up information received on 11-MAY-2021 contains non-significant information.

Other Meds: ASPIRIN [ACETYLSALICYLIC ACID]; TRAZODONE; AMLODIPINE; MVI [VITAMINS NOS]; SIMVASTATIN

Current Illness:

ID: 1557260
Sex: F
Age: 34
State: NC

Vax Date: 02/25/2021
Onset Date: 02/25/2021
Rec V Date: 08/14/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Unevaluable event

Symptoms: Chills; Headache; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), HEADACHE (Headache) and FATIGUE (Fatigue) in a 34-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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced CHILLS (Chills), HEADACHE (Headache) and FATIGUE (Fatigue). At the time of the report, CHILLS (Chills), HEADACHE (Headache) and FATIGUE (Fatigue) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications were not provided. Treatment information was not provided.

Other Meds:

Current Illness:

ID: 1557261
Sex: F
Age: 71
State: PA

Vax Date: 02/05/2021
Onset Date: 02/05/2021
Rec V Date: 08/14/2021
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: flushing in her face; This spontaneous case was reported by a consumer and describes the occurrence of FLUSHING (flushing in her face) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20) for COVID-19 vaccination. The patient's past medical history included Surgery (Surgery in right arm due to cancer). On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced FLUSHING (flushing in her face). On 05-Feb-2021, FLUSHING (flushing in her face) had resolved. 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. Concomitant medication was not provided. Treatment information was not provided. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1557262
Sex: M
Age: 35
State:

Vax Date: 01/26/2021
Onset Date: 01/26/2021
Rec V Date: 08/14/2021
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: Abdominal pain; Difficulty of breathing; Muscle pain; This spontaneous case was reported by a nurse and describes the occurrence of ABDOMINAL PAIN (Abdominal pain), DYSPNOEA (Difficulty of breathing) and MYALGIA (Muscle pain) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Asthma. Concomitant products included VITAMIN B12 NOS for an unknown indication. On 26-Jan-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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 26-Jan-2021, the patient experienced ABDOMINAL PAIN (Abdominal pain), DYSPNOEA (Difficulty of breathing) and MYALGIA (Muscle pain). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 27-Jan-2021, ABDOMINAL PAIN (Abdominal pain), DYSPNOEA (Difficulty of breathing) and MYALGIA (Muscle pain) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. This case was linked to MOD-2021-026685 (Patient Link).

Other Meds: VITAMIN B12 NOS

Current Illness: Asthma

ID: 1557263
Sex: F
Age: 72
State: MI

Vax Date: 02/11/2021
Onset Date: 02/11/2021
Rec V Date: 08/14/2021
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 consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itching around injection site), VACCINATION SITE PAIN (Pain at the injection site), VACCINATION SITE RASH (Rash around injection site) and RASH (Rash fades away and comes back) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015m20a) for COVID-19 vaccination. Concurrent medical conditions included Hypertension. Concomitant products included TOCOPHERYL ACETATE (EVITA) for an unknown indication. On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced VACCINATION SITE PAIN (Pain at the injection site). On 15-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Itching around injection site) and VACCINATION SITE RASH (Rash around injection site). On an unknown date, the patient experienced RASH (Rash fades away and comes back). At the time of the report, VACCINATION SITE PRURITUS (Itching around injection site), VACCINATION SITE PAIN (Pain at the injection site), VACCINATION SITE RASH (Rash around injection site) and RASH (Rash fades away and comes back) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medication included Blood pressure medications. Treatment information was not provided.

Other Meds: EVITA

Current Illness: Hypertension

ID: 1557264
Sex: F
Age: 82
State: NY

Vax Date: 02/15/2021
Onset Date: 02/16/2021
Rec V Date: 08/14/2021
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: Red band around arm; warm; itchiness; redness; soreness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Red band around arm), VACCINATION SITE WARMTH (warm), VACCINATION SITE PRURITUS (itchiness), VACCINATION SITE ERYTHEMA (redness) and MYALGIA (soreness) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination. Concomitant products included PROPRANOLOL for Hypertension, ASCORBIC ACID, BETACAROTENE, CUPRIC OXIDE, TOCOPHERYL ACETATE, ZINC OXIDE (PRESERVISION), CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) and FOLIC ACID for an unknown indication. On 15-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 VACCINATION SITE WARMTH (warm), VACCINATION SITE PRURITUS (itchiness), VACCINATION SITE ERYTHEMA (redness) and MYALGIA (soreness). On 18-Feb-2021, the patient experienced VACCINATION SITE REACTION (Red band around arm). On 18-Feb-2021, VACCINATION SITE PRURITUS (itchiness) had resolved. On 20-Feb-2021, VACCINATION SITE WARMTH (warm) and MYALGIA (soreness) had resolved, VACCINATION SITE ERYTHEMA (redness) outcome was unknown. On 23-Feb-2021, VACCINATION SITE REACTION (Red band around arm) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: Follow up received on 03-MAY-2021 and contains concomitant medications, events out come, new events were updated.

Other Meds: PROPRANOLOL; PRESERVISION; VITAMIN D 2000; FOLIC ACID

Current Illness:

ID: 1557265
Sex: F
Age: 61
State: KS

Vax Date: 02/25/2021
Onset Date: 02/26/2021
Rec V Date: 08/14/2021
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: This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Stomach feels weird) and PYREXIA (Fever of 101.2) in a 61-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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced ABDOMINAL DISCOMFORT (Stomach feels weird) and PYREXIA (Fever of 101.2). At the time of the report, ABDOMINAL DISCOMFORT (Stomach feels weird) outcome was unknown and PYREXIA (Fever of 101.2) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Feb-2021, Body temperature: 101.2 (Inconclusive) 101.2. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications were not provided. Patient has not taken anything to treat the symptom.

Other Meds:

Current Illness:

ID: 1557266
Sex: M
Age: 67
State: AZ

Vax Date: 02/12/2021
Onset Date:
Rec V Date: 08/14/2021
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: Fell on the floor for almost an hour before help arrived; Light headedness; Sick to stomach; Nausea; Joint pain, kneel pain; This spontaneous case was reported by a consumer and describes the occurrence of FALL (Fell on the floor for almost an hour before help arrived), DIZZINESS (Light headedness), ABDOMINAL DISCOMFORT (Sick to stomach), NAUSEA (Nausea) and ARTHRALGIA (Joint pain, kneel pain) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included Broken bones. Concurrent medical conditions included Hypertension. Concomitant products included LISINOPRIL for Hypertension, OXYCODONE, OXYCODONE HYDROCHLORIDE (OXYCONTIN) and GABAPENTIN (NEURONTIN) for Pain. On 12-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 FALL (Fell on the floor for almost an hour before help arrived), DIZZINESS (Light headedness), ABDOMINAL DISCOMFORT (Sick to stomach), NAUSEA (Nausea) and ARTHRALGIA (Joint pain, kneel pain). At the time of the report, FALL (Fell on the floor for almost an hour before help arrived), DIZZINESS (Light headedness), ABDOMINAL DISCOMFORT (Sick to stomach), NAUSEA (Nausea) and ARTHRALGIA (Joint pain, kneel pain) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Treatment information was not provided.

Other Meds: OXYCODONE; OXYCONTIN; NEURONTIN; LISINOPRIL

Current Illness: Hypertension

ID: 1557267
Sex: U
Age:
State: PA

Vax Date:
Onset Date:
Rec V Date: 08/14/2021
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: administered 0.3 ml instead of the recommended 0.5 ml dose; A spontaneous report was received from a Pharmacist (a PharmD) concerning seven patient (reporter was not sure about the number) (ages and genders unknown) who received Moderna's COVID-19 vaccine (mRNA-1273) and were administered 0.3 ml instead of the recommended 0.5ml dose (accidental underdose). No medical histories were provided. Concomitant product use was not provided. On unspecified dates, the patients received doses of mRNA-1273 (lot number: 031M20A) intramuscularly for prophylaxis of COVID-19 infection. The reporter, who was calling on behalf of another pharmacist, stated that one "intern" administered 0.3 ml instead of the recommended 0.5ml dose of Moderna vaccine to seven patients (the reporter was not sure about the number of patients). Action taken with mRNA-1273 in response to the event was not applicable. The outcome of the event was considered resolved.; Reporter's Comments: This report refers to a case of accidental underdose for mRNA-1273 (lot # 031M20A) with no associated AEs reported.

Other Meds:

Current Illness:

ID: 1557268
Sex: F
Age: 57
State: TX

Vax Date: 02/25/2021
Onset Date:
Rec V Date: 08/14/2021
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: Rash throughout body; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash throughout body) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination. No Medical History information was reported. On 25-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 RASH (Rash throughout body). At the time of the report, RASH (Rash throughout body) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medications were not provided. Treatment information was not provided.

Other Meds:

Current Illness:

ID: 1557269
Sex: F
Age:
State: WI

Vax Date: 02/01/2021
Onset Date: 02/01/2021
Rec V Date: 08/14/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site pain

Symptoms: Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) 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. In February 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. In February 2021, the patient experienced HEADACHE (Headache). At the time of the report, HEADACHE (Headache) outcome was unknown. No relevant concomitant medications were reported. Treatment information was not provided.

Other Meds:

Current Illness:

ID: 1557270
Sex: M
Age: 60
State: CA

Vax Date: 01/20/2021
Onset Date: 01/21/2021
Rec V Date: 08/14/2021
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: This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (COVID Fogginess), INTERCHANGE OF VACCINE PRODUCTS (received Pfizer vaccine as 2nd dose) and PYREXIA (Fever - Temperature of 99.0F) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination. Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) 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 30-Jun-2021 at 3:00 AM, the patient received second dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) .3 ml. On 21-Jan-2021, the patient experienced FEELING ABNORMAL (COVID Fogginess) and PYREXIA (Fever - Temperature of 99.0F). On 30-Jun-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (received Pfizer vaccine as 2nd dose). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] for Adverse event, at an unspecified dose and frequency. On 23-Jan-2021, FEELING ABNORMAL (COVID Fogginess) and PYREXIA (Fever - Temperature of 99.0F) had resolved. On 30-Jun-2021, INTERCHANGE OF VACCINE PRODUCTS (received Pfizer vaccine as 2nd dose) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Jan-2021, Body temperature: 99.0 (Inconclusive) 99.0F. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications reported. Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2021: Added reporter information and event.

Other Meds:

Current Illness:

ID: 1557271
Sex: F
Age: 74
State: NV

Vax Date: 01/20/2021
Onset Date: 02/17/2021
Rec V Date: 08/14/2021
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: ARTHRITIS; Dull headaches; Head and neck hurting; stiff neck/ PROBLEM MOVING MY NECK; crackling sound from her neck; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Head and neck hurting), MUSCULOSKELETAL STIFFNESS (stiff neck/ PROBLEM MOVING MY NECK), JOINT NOISE (crackling sound from her neck), ARTHRITIS (ARTHRITIS) and HEADACHE (Dull headaches) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 028L20A) for COVID-19 vaccination. Concurrent medical conditions included Cerebral palsy. On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Feb-2021, the patient experienced PAIN (Head and neck hurting) and JOINT NOISE (crackling sound from her neck). 17-Feb-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (stiff neck/ PROBLEM MOVING MY NECK). On an unknown date, the patient experienced ARTHRITIS (ARTHRITIS) and HEADACHE (Dull headaches). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN (Head and neck hurting), MUSCULOSKELETAL STIFFNESS (stiff neck/ PROBLEM MOVING MY NECK), JOINT NOISE (crackling sound from her neck), ARTHRITIS (ARTHRITIS) and HEADACHE (Dull headaches) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: abnormal (abnormal) CT scan results includes diagnosis of stenosis of spine.. No Concomitant medication was provided. Other treatment included 8 Hour arthritis Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: Follow up was received on 20-JUL-2021 Patient lab details CT scan was Added diagnosed with stenosis of spine and Treatment information was added 8 hour arthrits

Other Meds:

Current Illness: Cerebral palsy

ID: 1557272
Sex: F
Age: 66
State: NJ

Vax Date: 01/05/2021
Onset Date: 01/12/2021
Rec V Date: 08/14/2021
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: Covid-19; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of COVID-19 (Covid-19) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011L20A and 007A21A) 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 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On 12-Jan-2021, the patient experienced COVID-19 (Covid-19). At the time of the report, COVID-19 (Covid-19) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive Positive. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were given to the patient. The patient received monoclonal antibodies none days after vaccine administration. This case was linked to MOD-2021-011079 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 14-Apr-2021: email, address, birth date, product start date and batch number updated; Reporter's Comments: This case concerns a female of unknown age who experienced aa serious unexpected event of COVID-19. The event occurred 6 days after the first dose of mRNA-1273 and was treated with monoclonal antibody infusion. Event outcome unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1557273
Sex: F
Age: 72
State: AZ

Vax Date: 02/25/2021
Onset Date: 02/25/2021
Rec V Date: 08/14/2021
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: Muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Muscle pain) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 341240) for COVID-19 vaccination. The patient's past medical history included No adverse event. On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, the patient experienced MYALGIA (Muscle pain). At the time of the report, MYALGIA (Muscle pain) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Treatment information was not provided. Concomitant information was not provided.

Other Meds:

Current Illness:

ID: 1557274
Sex: F
Age: 40
State: CA

Vax Date: 02/05/2021
Onset Date: 02/05/2021
Rec V Date: 08/14/2021
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: a little bit of pain; she has her arm in which she received the vaccine warm to the touch; he has her arm in which she received the vaccine red; she has her arm in which she received the vaccine tender; she has her arm in which she received the vaccine swollen; a little bit of pain; This spontaneous case was reported by a consumer and describes the occurrence of the first episode of PAIN (a little bit of pain), VACCINATION SITE WARMTH (she has her arm in which she received the vaccine warm to the touch), INJECTION SITE ERYTHEMA (he has her arm in which she received the vaccine red), INJECTION SITE PAIN (she has her arm in which she received the vaccine tender) and VACCINATION SITE SWELLING (she has her arm in which she received the vaccine swollen) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041CZ010D) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Arthritis since an unknown date. Concurrent medical conditions included Seasonal allergy (Patient is taking allergy medicine for seasonal allergies.). Concomitant products included NAPROXEN for Arthritis. On 05-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) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced the first episode of PAIN (a little bit of pain), VACCINATION SITE WARMTH (she has her arm in which she received the vaccine warm to the touch), INJECTION SITE ERYTHEMA (he has her arm in which she received the vaccine red), INJECTION SITE PAIN (she has her arm in which she received the vaccine tender), VACCINATION SITE SWELLING (she has her arm in which she received the vaccine swollen) and the second episode of PAIN (a little bit of pain). At the time of the report, VACCINATION SITE WARMTH (she has her arm in which she received the vaccine warm to the touch), INJECTION SITE ERYTHEMA (he has her arm in which she received the vaccine red), INJECTION SITE PAIN (she has her arm in which she received the vaccine tender), VACCINATION SITE SWELLING (she has her arm in which she received the vaccine swollen) and the last episode of PAIN (a little bit of pain) outcome was unknown. No treatment information provided.

Other Meds: NAPROXEN

Current Illness: Arthritis; Seasonal allergy (Patient is taking allergy medicine for seasonal allergies.)

ID: 1557275
Sex: M
Age:
State: NC

Vax Date: 02/03/2021
Onset Date: 02/03/2021
Rec V Date: 08/14/2021
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: Rash like flaky, dry, itchy, dandruff, broken skin; rash like flaky, dry, itchy, dandruff, broken skin; Like dandruff; rash like flaky, dry, itchy, dandruff, broken skin; Rash on chest that started like pimples and spread neck, below the scalp, and behind and inside ears; pain in muscle of injection site and soreness; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Rash like flaky, dry, itchy, dandruff, broken skin), SKIN EXFOLIATION (rash like flaky, dry, itchy, dandruff, broken skin), DANDRUFF (Like dandruff), DRY SKIN (rash like flaky, dry, itchy, dandruff, broken skin) and RASH (Rash on chest that started like pimples and spread neck, below the scalp, and behind and inside ears) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. Concomitant products included LISINOPRIL, GEMFIBROZIL, OMEPRAZOLE, ASPIRIN [ACETYLSALICYLIC ACID], VITAMIN D [VITAMIN D NOS], ALPRAZOLAM and EZETIMIBE for an unknown indication. On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, the patient experienced VACCINATION SITE PAIN (pain in muscle of injection site and soreness). On an unknown date, the patient experienced RASH PRURITIC (Rash like flaky, dry, itchy, dandruff, broken skin), SKIN EXFOLIATION (rash like flaky, dry, itchy, dandruff, broken skin), DANDRUFF (Like dandruff), DRY SKIN (rash like flaky, dry, itchy, dandruff, broken skin) and RASH (Rash on chest that started like pimples and spread neck, below the scalp, and behind and inside ears). At the time of the report, RASH PRURITIC (Rash like flaky, dry, itchy, dandruff, broken skin), SKIN EXFOLIATION (rash like flaky, dry, itchy, dandruff, broken skin), DANDRUFF (Like dandruff), DRY SKIN (rash like flaky, dry, itchy, dandruff, broken skin), RASH (Rash on chest that started like pimples and spread neck, below the scalp, and behind and inside ears) and VACCINATION SITE PAIN (pain in muscle of injection site and soreness) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Treatment information included OTC ointment, dry skin lotion, spray on hear, Topical cream and special shampoo.

Other Meds: LISINOPRIL; GEMFIBROZIL; OMEPRAZOLE; ASPIRIN [ACETYLSALICYLIC ACID]; VITAMIN D [VITAMIN D NOS]; ALPRAZOLAM; EZETIMIBE

Current Illness:

ID: 1557276
Sex: F
Age:
State: MI

Vax Date:
Onset Date:
Rec V Date: 08/14/2021
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: really sick; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (really sick) in an adult female patient 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (really sick). At the time of the report, ILLNESS (really sick) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were reported. No treatment medications were reported.

Other Meds:

Current Illness:

ID: 1557277
Sex: F
Age: 64
State:

Vax Date: 02/26/2021
Onset Date: 02/27/2021
Rec V Date: 08/14/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site erythema, Injection site pain, Injection site swelling

Symptoms: Arm feeling very warm; Redness that is spreading on her vaccination arm; Chills like she had the flu; Chills like she had the flu; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of INFLUENZA LIKE ILLNESS (Chills like she had the flu), FEELING HOT (Arm feeling very warm), VACCINATION SITE ERYTHEMA (Redness that is spreading on her vaccination arm) and CHILLS (Chills like she had the flu) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No relevant concomitant medications reported. No relevant medical history 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 INFLUENZA LIKE ILLNESS (Chills like she had the flu) and CHILLS (Chills like she had the flu). On 01-Mar-2021, the patient experienced FEELING HOT (Arm feeling very warm) and VACCINATION SITE ERYTHEMA (Redness that is spreading on her vaccination arm). The patient was treated with PARACETAMOL (TYLENOL) for Chills, at an unspecified dose and frequency. On 28-Feb-2021, INFLUENZA LIKE ILLNESS (Chills like she had the flu) and CHILLS (Chills like she had the flu) had resolved. At the time of the report, FEELING HOT (Arm feeling very warm) and VACCINATION SITE ERYTHEMA (Redness that is spreading on her vaccination arm) 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.

Other Meds:

Current Illness:

ID: 1557278
Sex: F
Age: 78
State:

Vax Date: 02/15/2021
Onset Date: 02/17/2021
Rec V Date: 08/14/2021
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: High blood pressure; up and down heart rate; Dry mouth; Taste of Salt; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (High blood pressure), PALPITATIONS (up and down heart rate), DRY MOUTH (Dry mouth) and DYSGEUSIA (Taste of Salt) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) 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) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced HYPERTENSION (High blood pressure), PALPITATIONS (up and down heart rate), DRY MOUTH (Dry mouth) and DYSGEUSIA (Taste of Salt). At the time of the report, HYPERTENSION (High blood pressure), PALPITATIONS (up and down heart rate) and DRY MOUTH (Dry mouth) had not resolved and DYSGEUSIA (Taste of Salt) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were provided. No treatment information provided. This case was linked to US-MODERNATX, INC.-MOD-2021-101121 (E2B Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2021-101121:

Other Meds:

Current Illness:

ID: 1557279
Sex: F
Age: 89
State: SD

Vax Date: 02/25/2021
Onset Date: 02/26/2021
Rec V Date: 08/14/2021
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: Body ache; Fatigue; Fever of 100.2F; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Body ache), FATIGUE (Fatigue) and PYREXIA (Fever of 100.2F) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included No adverse event. On 25-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced MYALGIA (Body ache), FATIGUE (Fatigue) and PYREXIA (Fever of 100.2F). The patient was treated with TRAMADOL at a dose of 1 dosage form and PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, MYALGIA (Body ache), FATIGUE (Fatigue) and PYREXIA (Fever of 100.2F) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Feb-2021, Pyrexia: 100.2 Fever of 100.2F. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were reported.

Other Meds:

Current Illness:

ID: 1557280
Sex: F
Age:
State: TX

Vax Date: 02/19/2021
Onset Date:
Rec V Date: 08/14/2021
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: Heat goes right to her head; Chills; Nauseous; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (Heat goes right to her head), CHILLS (Chills) and NAUSEA (Nauseous) 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 19-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 an unknown date, the patient experienced FEELING HOT (Heat goes right to her head), CHILLS (Chills) and NAUSEA (Nauseous). At the time of the report, FEELING HOT (Heat goes right to her head), CHILLS (Chills) and NAUSEA (Nauseous) outcome was unknown. Action taken with mRNA-1273 in response to the events was not applicable. Concomitant and treatment information were not provided.

Other Meds:

Current Illness:

ID: 1557281
Sex: F
Age:
State: IL

Vax Date:
Onset Date:
Rec V Date: 08/14/2021
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: Flu-like symptoms; 3 days of body aches; Nausea; Chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu-like symptoms), PAIN (3 days of body aches), NAUSEA (Nausea), CHILLS (Chills) and PYREXIA (Fever) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like symptoms), NAUSEA (Nausea), CHILLS (Chills) and PYREXIA (Fever). an unknown date, the patient experienced PAIN (3 days of body aches). At the time of the report, INFLUENZA LIKE ILLNESS (Flu-like symptoms), PAIN (3 days of body aches), NAUSEA (Nausea), CHILLS (Chills) and PYREXIA (Fever) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Relevant concomitant product usage were not reported by the reporter. No treatment details were added.

Other Meds:

Current Illness:

ID: 1557282
Sex: F
Age: 71
State: MI

Vax Date: 02/13/2021
Onset Date: 02/25/2021
Rec V Date: 08/14/2021
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: Covid arm; Itchy at injection site; Swollen at injection site; Flu like symptoms; Nausea; Tired; Headache; Achy; Weakness; Stomachache; This spontaneous case was reported by a health care professional and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), VACCINATION SITE REACTION (Covid arm), PAIN (Achy), ASTHENIA (Weakness) and ABDOMINAL PAIN UPPER (Stomachache) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and ATORVASTATIN CALCIUM (LIPITOR) for an unknown indication. On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), PAIN (Achy), ASTHENIA (Weakness), ABDOMINAL PAIN UPPER (Stomachache), NAUSEA (Nausea), FATIGUE (Tired) and HEADACHE (Headache). On an unknown date, the patient experienced VACCINATION SITE REACTION (Covid arm), VACCINATION SITE PRURITUS (Itchy at injection site) and VACCINATION SITE SWELLING (Swollen at injection site). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 24-Feb-2021, VACCINATION SITE REACTION (Covid arm), VACCINATION SITE PRURITUS (Itchy at injection site) and VACCINATION SITE SWELLING (Swollen at injection site) had resolved. At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms), PAIN (Achy), ASTHENIA (Weakness), ABDOMINAL PAIN UPPER (Stomachache), NAUSEA (Nausea), FATIGUE (Tired) and HEADACHE (Headache) outcome was unknown. 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: SYNTHROID; LIPITOR

Current Illness:

ID: 1557283
Sex: M
Age: 80
State:

Vax Date: 02/23/2021
Onset Date: 02/24/2021
Rec V Date: 08/14/2021
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: . On an unspecified date, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly for prophylaxis of COVID-19 infection. On an 23 Feb 2021, one day prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 002A21A) intramuscularly for prophylaxis of COVID-19 infection. On 24 Feb 2021, the patient experienced the event(s) dizziness, nausea, vomiting. No treatment information was provided. Action taken with mRNA-1273 in response to the events was considered to be not applicable. The outcome of event(s), dizziness, nausea, vomiting was unknown.

Other Meds:

Current Illness:

ID: 1557284
Sex: F
Age: 65
State: GA

Vax Date: 02/26/2021
Onset Date: 02/26/2021
Rec V Date: 08/14/2021
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: Arm is sore at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Arm is sore at the injection site) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) 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 INJECTION SITE PAIN (Arm is sore at the injection site). At the time of the report, INJECTION SITE PAIN (Arm is sore at the injection site) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant was provided. Patient treatment information was no provided.

Other Meds:

Current Illness:

ID: 1557285
Sex: F
Age: 68
State: CA

Vax Date: 02/15/2021
Onset Date: 02/23/2021
Rec V Date: 08/14/2021
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: Warm to the touch at the site of injection; Red sore knot at the injection site; Red sore knot at the injection site; Headache; Low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (Warm to the touch at the site of injection), VACCINATION SITE INDURATION (Red sore knot at the injection site), INJECTION SITE ERYTHEMA (Red sore knot at the injection site), HEADACHE (Headache) and PYREXIA (Low grade fever) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 91M20A) for COVID-19 vaccination. No Medical History information was reported. On 15-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, the patient experienced INJECTION SITE WARMTH (Warm to the touch at the site of injection), VACCINATION SITE INDURATION (Red sore knot at the injection site), INJECTION SITE ERYTHEMA (Red sore knot at the injection site), HEADACHE (Headache) and PYREXIA (Low grade fever). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, INJECTION SITE WARMTH (Warm to the touch at the site of injection), VACCINATION SITE INDURATION (Red sore knot at the injection site), INJECTION SITE ERYTHEMA (Red sore knot at the injection site), HEADACHE (Headache) and PYREXIA (Low grade fever) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No relevant concomitant medications were provided.

Other Meds:

Current Illness:

ID: 1557286
Sex: U
Age:
State: AZ

Vax Date: 02/25/2021
Onset Date: 02/25/2021
Rec V Date: 08/14/2021
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: Vaccine leaked out of syringe, patient received deviation from normal dose; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (Vaccine leaked out of syringe, patient received deviation from normal dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included No adverse event. On 25-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 25-Feb-2021, the patient experienced UNDERDOSE (Vaccine leaked out of syringe, patient received deviation from normal dose). At the time of the report, UNDERDOSE (Vaccine leaked out of syringe, patient received deviation from normal dose) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medications were not provided. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1557287
Sex: M
Age: 62
State: VA

Vax Date: 01/28/2021
Onset Date: 01/29/2021
Rec V Date: 08/14/2021
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: "Nut" on the elbow after getting the second dose of Moderna COVID-19; High temperature; Chills; This spontaneous case was reported by a consumer and describes the occurrence of JOINT SWELLING ("Nut" on the elbow after getting the second dose of Moderna COVID-19), PYREXIA (High temperature) and CHILLS (Chills) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027620A) for COVID-19 vaccination. No Medical History information was reported. On 28-Jan-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) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced JOINT SWELLING ("Nut" on the elbow after getting the second dose of Moderna COVID-19), PYREXIA (High temperature) and CHILLS (Chills). At the time of the report, JOINT SWELLING ("Nut" on the elbow after getting the second dose of Moderna COVID-19), PYREXIA (High temperature) and CHILLS (Chills) had resolved. No concomitant medications were reported. No treatment information was provided. Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: The follow up received contain significant information :outcome of the events changed from unknown to recovered.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1557288
Sex: M
Age: 80
State: NV

Vax Date: 02/11/2021
Onset Date:
Rec V Date: 08/14/2021
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: 2 week later,light pink around injection site; Developing a rash and redness spreading; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOLOURATION (2 week later,light pink around injection site) and VACCINATION SITE RASH (Developing a rash and redness spreading) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination. The patient's past medical history included No adverse event. Concomitant products included SACUBITRIL VALSARTAN SODIUM HYDRATE (ENTRESTO) for an unknown indication. On 11-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 VACCINATION SITE DISCOLOURATION (2 week later,light pink around injection site) and VACCINATION SITE RASH (Developing a rash and redness spreading). At the time of the report, VACCINATION SITE DISCOLOURATION (2 week later,light pink around injection site) and VACCINATION SITE RASH (Developing a rash and redness spreading) 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. Treatment medication includes Thyroid pill.

Other Meds: ENTRESTO

Current Illness:

Total 2021 VAERS Injuries: 636,615

Page last modified: 03 October 2021 5:28pm