VAERS 2021 Database www.vaers.hhs.gov

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VAERS Updated: 10/01/2021
** VAERS DATABASE Last updated: October 1, 2021**
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Manufacturers

Total Manufacturer
187,133MODERNA
33,878JANSSEN
2,321PFIZER\BIONTECH
1,091GLAXOSMITHKLINE BIOLOGICALS
983UNKNOWN MANUFACTURER
363MERCK & CO. INC.
229SEQIRUS, INC.
45DYNAVAX TECHNOLOGIES CORPORATION
41NOVARTIS VACCINES AND DIAGNOSTICS
29SANOFI PASTEUR
18EMERGENT BIOSOLUTIONS
8PAXVAX
7TEVA PHARMACEUTICALS
4PFIZER\WYETH
3BERNA BIOTECH, LTD.
2SMITHKLINE BEECHAM
2INTERCELL AG
2PROTEIN SCIENCES CORPORATION
1CSL LIMITED

Incidents per State

State Total
77,548
AK1,869
AL5,581
AR3,688
AS47
AZ14,288
CA61,984
CO11,665
CT8,149
DC1,663
DE1,807
FL37,749
FM5
GA15,058
GU120
HI2,453
IA4,625
ID2,692
IL20,334
IN24,007
KS4,615
KY7,696
LA4,887
MA14,654
MD12,514
ME3,129
MH11
MI18,739
MN12,528
MO9,710
MP29
MS2,790
MT2,375
NC16,368
ND1,356
NE2,880
NH3,100
NJ17,634
NM3,916
NV4,239
NY34,355
OH19,081
OK6,195
OR8,636
PA23,083
PR2,370
QM2
RI2,088
SC6,411
SD1,212
TN9,131
TX35,174
UT4,273
VA14,937
VI64
VT1,676
WA14,909
WI11,259
WV2,388
WY861
XB5
XL1
XV2

ID: 1569972
Sex: F
Age: 37
State: PA

Vax Date: 03/17/2021
Onset Date: 03/18/2021
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: This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (stomach cramping), ASTHENIA (feels very weak), HYPERSOMNIA (sleeping all day), COVID-19 (feels like covid again) and PYREXIA (Fever for two days) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19 (She got Covid in Dec) in December 2019. On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced PYREXIA (Fever for two days). On an unknown date, the patient experienced ABDOMINAL PAIN UPPER (stomach cramping), ASTHENIA (feels very weak), HYPERSOMNIA (sleeping all day), COVID-19 (feels like covid again) and HEADACHE (really bad headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, ABDOMINAL PAIN UPPER (stomach cramping), ASTHENIA (feels very weak), HYPERSOMNIA (sleeping all day), COVID-19 (feels like covid again), PYREXIA (Fever for two days) and HEADACHE (really bad headache) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. no concomitant medications are provided. second dose is scheduled on 14Apr2021. patient feels like she has COVID again which she had in December and called out of work both days.

Other Meds:

Current Illness:

ID: 1569973
Sex: U
Age: 76
State: FL

Vax Date: 03/18/2021
Onset Date: 03/18/2021
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: temperature of 99.3F/temperature of 101.1F; body aches; bedridden all day; slept all day; right arm hurt and woke her up; nauseated; headache from back of her neck to the entire head; shot hurt a lot; Orbs around my eyes hurt; Loss of weight; sick as a dog; loss of smell; loss of taste; Overwhelming fatigue; This spontaneous case was reported by a consumer and describes the occurrence of BEDRIDDEN (bedridden all day), HYPERSOMNIA (slept all day), ILLNESS (sick as a dog), ANOSMIA (loss of smell) and AGEUSIA (loss of taste) in a 76-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19 from 16-Feb-2021 to 23-Feb-2021 and Pacemaker insertion (cardiac). Concurrent medical conditions included Drug allergy (Allergic to Glucophage, Januvia, Lipitor and Premarin drugs.) and Diabetes. Concomitant products included MULTIVITAMINS [VITAMINS NOS], RIVAROXABAN (XARELTO), METFORMIN HYDROCHLORIDE, HYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUM (LOSARTAN HCTZ), GLYBURIDE, SIMVASTATIN, METOPROLOL TARTRATE, ASCORBIC ACID, BETACAROTENE, CUPRIC OXIDE, TOCOPHERYL ACETATE, ZINC OXIDE (PRESERVISION), FERROUS SULFATE (SLOW IRON), COLECALCIFEROL (D3 5000), UBIDECARENONE (COQ10 [UBIDECARENONE]), L-CARNITINE [LEVOCARNITINE], ASPIRIN [ACETYLSALICYLIC ACID], BIOTIN, VITAMIN B COMPLEX and CANNABIDIOL (CBD OIL) for an unknown indication. On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced ILLNESS (sick as a dog), ANOSMIA (loss of smell), AGEUSIA (loss of taste), EYE PAIN (Orbs around my eyes hurt), WEIGHT DECREASED (Loss of weight), VACCINATION SITE PAIN (shot hurt a lot) and FATIGUE (Overwhelming fatigue). On 19-Mar-2021, the patient experienced BEDRIDDEN (bedridden all day), HYPERSOMNIA (slept all day), PAIN IN EXTREMITY (right arm hurt and woke her up), NAUSEA (nauseated), HEADACHE (headache from back of her neck to the entire head) and MYALGIA (body aches). On 20-Mar-2021, the patient experienced PYREXIA (temperature of 99.3F/temperature of 101.1F). On 20-Mar-2021, MYALGIA (body aches) had resolved. On 21-Mar-2021, BEDRIDDEN (bedridden all day), HYPERSOMNIA (slept all day), ILLNESS (sick as a dog), ANOSMIA (loss of smell), AGEUSIA (loss of taste), PAIN IN EXTREMITY (right arm hurt and woke her up), EYE PAIN (Orbs around my eyes hurt), WEIGHT DECREASED (Loss of weight), NAUSEA (nauseated), HEADACHE (headache from back of her neck to the entire head), VACCINATION SITE PAIN (shot hurt a lot), PYREXIA (temperature of 99.3F/temperature of 101.1F) and FATIGUE (Overwhelming fatigue) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Mar-2021, Body temperature: 99.3 (High) 99.3 F and 101.1 (High) 101.1 F. On an unknown date, Body temperature: 101.8 (High) 101.8 F and 100.1 (High) 100.1. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. This case was linked to MOD-2021-136082 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Non significant follow up received on 10-MAY-2021, No new information On 11-May-2021: Non significant follow up received on 11-MAY-2021, No new information On 17-May-2021: significant follow up received on 17-MAY-2021, Updated patient demographics, updated medical history, changed re-challenge from not applicable to positive, updated re-challenge date, added additional concomitant medications, updated all events stop date and changed outcome of all events from unknown to recovered/resolved.

Other Meds: MULTIVITAMINS [VITAMINS NOS]; XARELTO; METFORMIN HYDROCHLORIDE; LOSARTAN HCTZ; GLYBURIDE; SIMVASTATIN; METOPROLOL TARTRATE; PRESERVISION; SLOW IRON; D3 5000; COQ10 [UBIDECARENONE]; L-CARNITINE [LEVOCARNITINE]; ASPIRIN [ACETYLSALICYLIC ACID]

Current Illness: Diabetes; Drug allergy (Allergic to Glucophage, Januvia, Lipitor and Premarin drugs.)

ID: 1569974
Sex: F
Age: 65
State: NM

Vax Date: 03/09/2021
Onset Date: 03/09/2021
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: This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was sore), VACCINATION SITE WARMTH (hot), VACCINATION SITE PRURITUS (itchy), VACCINATION SITE ERYTHEMA (red) and VACCINATION SITE SWELLING (puffy) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027421A) for COVID-19 vaccination. Concomitant products included DESVENLAFAXINE SUCCINATE (PRISTIQ), STRESS B COMPLEX [AMINOBENZOIC ACID;ASCORBIC ACID; BIOTIN; CALCIUM PANTOTHENATE; CHOLINE BITARTRATE; CYANOCOBALAMIN; FOLIC ACID; INOSITOL; NICOTINIC ACID; PYRIDOXINE HYDROCHLORIDE;RIBOFLAVIN;ROSA CANINA;THIAMINE MONONITRATE], CLONAZEPAM and APOAEQUORIN (PREVAGEN [APOAEQUORIN]) for an unknown indication. On 09-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm was sore). On 18-Mar-2021, the patient experienced VACCINATION SITE WARMTH (hot), VACCINATION SITE PRURITUS (itchy), VACCINATION SITE ERYTHEMA (red) and VACCINATION SITE SWELLING (puffy). At the time of the report, PAIN IN EXTREMITY (arm was sore), VACCINATION SITE WARMTH (hot), VACCINATION SITE PRURITUS (itchy), VACCINATION SITE ERYTHEMA (red) and VACCINATION SITE SWELLING (puffy) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Event outcome and treatment details were not reported.

Other Meds: PRISTIQ; STRESS B COMPLEX [AMINOBENZOIC ACID;ASCORBIC ACID;BIOTIN;CALCIUM PANTOTHENATE;CHOLINE BITARTRATE;CYA; CLONAZEPAM; PREVAGEN [APOAEQUORIN]

Current Illness:

ID: 1569975
Sex: F
Age: 56
State: MS

Vax Date: 02/10/2021
Onset Date: 02/10/2021
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: Dizziness; Fever; This spontaneous case was reported by a nurse and describes the occurrence of DIZZINESS (Dizziness) and PYREXIA (Fever) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037k20A) for COVID-19 vaccination. No Medical History information was reported. On 10-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced DIZZINESS (Dizziness) and PYREXIA (Fever). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 13-Feb-2021, DIZZINESS (Dizziness) and PYREXIA (Fever) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. second dose was given to the deltoid muscle (unknown arm)

Other Meds:

Current Illness:

ID: 1569976
Sex: U
Age:
State: WA

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 erythema, Injection site pruritus, Injection site swelling, Injection site warmth

Symptoms: patient who received 0.13 mL, 1/4 of a dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of INCORRECT DOSE ADMINISTERED (patient who received 0.13 mL, 1/4 of a dose) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .13 ml. On an unknown date, the patient experienced INCORRECT DOSE ADMINISTERED (patient who received 0.13 mL, 1/4 of a dose). At the time of the report, INCORRECT DOSE ADMINISTERED (patient who received 0.13 mL, 1/4 of a dose) had resolved. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication reported. Treatment information not provided.

Other Meds:

Current Illness:

ID: 1569977
Sex: M
Age:
State: MA

Vax Date:
Onset Date:
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: COVID arm; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE REACTION (COVID arm) 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 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 VACCINATION SITE REACTION (COVID arm). At the time of the report, VACCINATION SITE REACTION (COVID 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. No concomitant medication was reported Treatment information was not provided.

Other Meds:

Current Illness:

ID: 1569978
Sex: F
Age: 68
State: MA

Vax Date: 02/18/2021
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: Pyrexia, White blood cell count decreased

Symptoms: Injection site redness; Injection site swelling; Injection site soreness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Injection site redness), VACCINATION SITE SWELLING (Injection site swelling) and VACCINATION SITE PAIN (Injection site soreness) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007B21A and 0024M20A) for COVID-19 vaccination. No Medical History information was reported. On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-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 VACCINATION SITE ERYTHEMA (Injection site redness), VACCINATION SITE SWELLING (Injection site swelling) and VACCINATION SITE PAIN (Injection site soreness). At the time of the report, VACCINATION SITE ERYTHEMA (Injection site redness), VACCINATION SITE SWELLING (Injection site swelling) and VACCINATION SITE PAIN (Injection site soreness) had not resolved. Not Provided No concomitant medications were reported. 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: 1569979
Sex: M
Age: 72
State: WA

Vax Date: 03/11/2021
Onset Date: 03/18/2021
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: Injection site is red rash; red rash orange in size; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Injection site is red rash) and VACCINATION SITE RASH (red rash orange in size) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. O4M20A) for COVID-19 vaccination. no medical information provided. Concomitant products included FENOFIBRATE, HYDROCHLOROTHIAZIDE (DICHLOTRIDE [HYDROCHLOROTHIAZIDE]) and CALCIUM LEVOMEFOLATE (METHYL FOLATE) for an unknown indication. On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced VACCINATION SITE RASH (Injection site is red rash) and VACCINATION SITE RASH (red rash orange in size). At the time of the report, VACCINATION SITE RASH (Injection site is red rash) and VACCINATION SITE RASH (red rash orange in size) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. treatment information not provided.

Other Meds: FENOFIBRATE; DICHLOTRIDE [HYDROCHLOROTHIAZIDE]; METHYL FOLATE

Current Illness:

ID: 1569980
Sex: F
Age: 72
State: IN

Vax Date: 01/26/2021
Onset Date: 02/22/2021
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: Abdominal pain, Chills, Sleep disorder

Symptoms: Experienced chills after second dose; after second dose her arm started to hurt; She could barely sleep because whole arm was so painful; She could barely sleep because whole arm was so painful; she cannot move her right arm at all after second dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (after second dose her arm started to hurt), INSOMNIA (She could barely sleep because whole arm was so painful), VACCINATION SITE MOVEMENT IMPAIRMENT (she cannot move her right arm at all after second dose), CHILLS (Experienced chills after second dose) and PAIN IN EXTREMITY (She could barely sleep because whole arm was so painful) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 029520A) for COVID-19 vaccination. Concurrent medical conditions included Asthma and Dry macular degeneration. Concomitant products included BUDESONIDE (PULMICORT) for Asthma, OLMESARTAN for Blood pressure abnormal, ASCORBIC ACID, COPPER GLUCONATE, TOCOPHERYL ACID SUCCINATE, XANTOFYL, ZEAXANTHIN, ZINC OXIDE (AREDS 2 VISUAL ADVANTAGE) for Dry macular degeneration, MIRTAZAPINE for Sedative therapy, BUPROPION HYDROCHLORIDE (WELLBUTRIN), MONTELUKAST SODIUM (SINGULAIR), CALCIUM, DOCOSAHEXAENOIC ACID, EICOSAPENTAENOIC ACID (OMEGA 3 [DOCOSAHEXAENOIC ACID;EICOSAPENTAENOIC ACID]) and MULTIVITAMIN [VITAMINS NOS] for an unknown indication. On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Feb-2021, the patient experienced VACCINATION SITE PAIN (after second dose her arm started to hurt), INSOMNIA (She could barely sleep because whole arm was so painful), VACCINATION SITE MOVEMENT IMPAIRMENT (she cannot move her right arm at all after second dose) and PAIN IN EXTREMITY (She could barely sleep because whole arm was so painful). On 23-Feb-2021, the patient experienced CHILLS (Experienced chills after second dose). The patient was treated with PARACETAMOL (TYLENOL EXTRA STRENGTH) from 23-Feb-2021 to 24-Feb-2021 for Adverse event, at a dose of 2 dosage form. On 24-Feb-2021, CHILLS (Experienced chills after second dose) had resolved. At the time of the report, VACCINATION SITE PAIN (after second dose her arm started to hurt), INSOMNIA (She could barely sleep because whole arm was so painful), VACCINATION SITE MOVEMENT IMPAIRMENT (she cannot move her right arm at all after second dose) and PAIN IN EXTREMITY (She could barely sleep because whole arm was so painful) outcome was unknown. Concomitant medication included probiotic supplement. The patient felt that Tylenol was helpful. It was reported that chills went away on 24-Feb-2021. On 24-Feb-2021, the arm was still hurting (in the muscles and top of shoulder). This case was linked to MOD-2021-024305 (E2B Linked Report).; Sender's Comments: MOD-2021-024305:

Other Meds: PULMICORT; WELLBUTRIN; OLMESARTAN; SINGULAIR; MIRTAZAPINE; AREDS 2 VISUAL ADVANTAGE; CALCIUM; OMEGA 3 [DOCOSAHEXAENOIC ACID;EICOSAPENTAENOIC ACID]; MULTIVITAMIN [VITAMINS NOS]

Current Illness: Asthma; Dry macular degeneration

ID: 1569981
Sex: F
Age:
State: KY

Vax Date: 03/10/2021
Onset Date: 03/11/2021
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: Hot at injection site/warm at injection site; Itchy at injection site; Fever; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Hot at injection site/warm at injection site), VACCINATION SITE PRURITUS (Itchy at injection site) 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 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced VACCINATION SITE WARMTH (Hot at injection site/warm at injection site), VACCINATION SITE PRURITUS (Itchy at injection site) and PYREXIA (Fever). At the time of the report, VACCINATION SITE WARMTH (Hot at injection site/warm at injection site), VACCINATION SITE PRURITUS (Itchy at injection site) and PYREXIA (Fever) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported. No treatment medications were reported.

Other Meds:

Current Illness:

ID: 1569982
Sex: M
Age: 48
State: MS

Vax Date: 02/10/2021
Onset Date: 02/10/2021
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: Headache; Sore Arm; Chills; This spontaneous case was reported by a nurse and describes the occurrence of HEADACHE (Headache), VACCINATION SITE PAIN (Sore Arm) and CHILLS (Chills) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination. No Medical History information was reported. On 10-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced HEADACHE (Headache), VACCINATION SITE PAIN (Sore Arm) and CHILLS (Chills). At the time of the report, HEADACHE (Headache), VACCINATION SITE PAIN (Sore Arm) and CHILLS (Chills) outcome was unknown. Not Provided For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication information was provided. No treatment medication information was provided. Action taken with mRNA-1273 in response to the drug was not applicable.

Other Meds:

Current Illness:

ID: 1569983
Sex: M
Age: 34
State: NY

Vax Date: 03/19/2021
Onset Date: 03/19/2021
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: This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination. The patient's past medical history included No adverse event. On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.

Other Meds:

Current Illness:

ID: 1569984
Sex: F
Age: 66
State: MS

Vax Date: 02/03/2021
Onset Date: 02/03/2021
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: Back Ache; Nausea; Vomiting; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of BACK PAIN (Back Ache), NAUSEA (Nausea) and VOMITING (Vomiting) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 immunisation. The patient's past medical history included No adverse event. On 03-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced BACK PAIN (Back Ache), NAUSEA (Nausea) and VOMITING (Vomiting). In February 2021, BACK PAIN (Back Ache), NAUSEA (Nausea) and VOMITING (Vomiting) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. Treatment information was not provided. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.

Other Meds:

Current Illness:

ID: 1569985
Sex: M
Age:
State: NV

Vax Date: 03/18/2021
Onset Date: 03/19/2021
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: Chills; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills) 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 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, the patient experienced CHILLS (Chills). At the time of the report, CHILLS (Chills) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. The concomitant medications and treatment details were not provided.

Other Meds:

Current Illness:

ID: 1569986
Sex: F
Age:
State: NC

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: LA

Lab Data:

Allergies:

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

Symptoms: fever; dizziness; headache; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), DIZZINESS (dizziness) and HEADACHE (headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Thyroid cancer. 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 PYREXIA (fever), DIZZINESS (dizziness) and HEADACHE (headache). At the time of the report, PYREXIA (fever), DIZZINESS (dizziness) and HEADACHE (headache) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. The patient was taking unspecified concomitants for thyroid cancer. The patient experienced dizziness, headaches, and fever following her dose and was taken by the rescue squad to the emergency room for her symptoms. She was not admitted to the hospital but was discharged from the emergency room after receiving a steroid injection for her symptoms.

Other Meds:

Current Illness: Thyroid cancer

ID: 1569987
Sex: F
Age:
State: IN

Vax Date: 03/15/2021
Onset Date:
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: Arm itching really bad; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Arm itching really bad) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination. No medical history was provided by reporter. On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRURITUS (Arm itching really bad). At the time of the report, PRURITUS (Arm itching really bad) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Most recent FOLLOW-UP information incorporated above includes: On 08-May-2021: TCR

Other Meds:

Current Illness:

ID: 1569988
Sex: F
Age: 63
State: CA

Vax Date: 03/10/2021
Onset Date: 03/10/2021
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: she had neck and back cramps; she had back cramps; itching; hot arm; swollen arm; can't move her arm; tiredness; vomiting; diarrhea; terrible headache; can't sleep; dizziness; everything hurts; her lungs hurt; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (she had neck and back cramps), BACK PAIN (she had back cramps), PRURITUS (itching), FEELING HOT (hot arm) and PERIPHERAL SWELLING (swollen arm) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included GABAPENTIN and DULOXETINE for an unknown indication. On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced MUSCLE SPASMS (she had neck and back cramps), BACK PAIN (she had back cramps), PRURITUS (itching), FEELING HOT (hot arm), PERIPHERAL SWELLING (swollen arm), LIMB DISCOMFORT (can't move her arm), FATIGUE (tiredness), VOMITING (vomiting), DIARRHOEA (diarrhea), HEADACHE (terrible headache), INSOMNIA (can't sleep), DIZZINESS (dizziness), PAIN (everything hurts) and PULMONARY PAIN (her lungs hurt). At the time of the report, MUSCLE SPASMS (she had neck and back cramps), BACK PAIN (she had back cramps), PRURITUS (itching), FEELING HOT (hot arm), PERIPHERAL SWELLING (swollen arm), LIMB DISCOMFORT (can't move her arm), FATIGUE (tiredness), VOMITING (vomiting), DIARRHOEA (diarrhea), HEADACHE (terrible headache), INSOMNIA (can't sleep), DIZZINESS (dizziness), PAIN (everything hurts) and PULMONARY PAIN (her lungs hurt) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.

Other Meds: GABAPENTIN; DULOXETINE

Current Illness:

ID: 1569989
Sex: F
Age:
State: NY

Vax Date: 03/17/2021
Onset Date: 03/18/2021
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: Bad headache; nausea; extremely fatigue; feeling sick; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Bad headache), NAUSEA (nausea), FATIGUE (extremely fatigue) and MALAISE (feeling sick) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination. The patient's past medical history included No adverse event (No reported medical history). On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced HEADACHE (Bad headache), NAUSEA (nausea), FATIGUE (extremely fatigue) and MALAISE (feeling sick). The patient was treated with PARACETAMOL (TYLENOL) for Paracetamol, at an unspecified dose and frequency. At the time of the report, HEADACHE (Bad headache), NAUSEA (nausea), FATIGUE (extremely fatigue) and MALAISE (feeling sick) was resolving. Unknown The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medication information not provided. Treatment medication include Tylenol.

Other Meds:

Current Illness:

ID: 1569990
Sex: F
Age: 65
State: VA

Vax Date: 03/17/2021
Onset Date: 03/17/2021
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: Feels uncomfortable; Pain came back into shoulder joint; Tenderness in her tissue; Agonizing painful joint (rate it 20 for 10); Vaccine given on the given on the hardest part of the muscle and very high/liquid has gone to her joint rather than to the muscle/sensation felt like needle went into the joint and not the muscle/believes the shot was given incorrectly; A spontaneous report (United States) was received from a consumer who was also a 65-years-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) on the hardest part of the muscle and very high; liquid has gone to her joint rather than to the muscle; sensation felt like needle went into the joint and not the muscle; believes the shot was given incorrectly/incorrect route of product administration and who experienced feels uncomfortable/malaise, agonizing painful joint (rate it 20 for 10); pain came back into shoulder joint/arthralgia and tenderness in her tissue/vaccination site pain. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 17 Mar 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: 002B21A (via an unknown route) intramuscularly in the hardest part of the muscle for prophylaxis of COVID-19 infection. On 17 Mar 2021, the patient received vaccine in the hardest part of the muscle and patient believes that the shot was given too high when administered. Patient stated that patient did not feel the needle go in, the sensation felt like the needle went into the joint and not the muscle. She added that it took 3.5 days for the severe pain to go away, but the day before reporting the pain woke patient from sleep. Patient described tenderness in tissue and the pain came back into shoulder joint was feeling uncomfortable. Patient believes the shot was given incorrectly. Treatment for the event included advil for agonizing painful joint (rate it 20 for 10). Action taken with mRNA-1273 in response to the events was not provided. The events, Vaccine given on the given on the hardest part of the muscle and very high/liquid has gone to her joint rather than to the muscle/sensation felt like needle went into the joint and not the muscle/believes the shot was given incorrectly, was recovered on 17 Feb 2021 and the event agonizing painful joint (rate it 20 for 10) was recovered on 20 Feb 2021. The outcome of other reported events was not reported.; Sender's Comments: MOD21-063203:MI Report

Other Meds:

Current Illness:

ID: 1569991
Sex: M
Age: 73
State: SC

Vax Date: 02/26/2021
Onset Date: 03/07/2021
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: disorientation; Persistent headache; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of DISORIENTATION (disorientation), HEADACHE (Persistent headache) and VACCINATION SITE PAIN (sore arm) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) 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 07-Mar-2021, the patient experienced DISORIENTATION (disorientation), HEADACHE (Persistent headache) and VACCINATION SITE PAIN (sore arm). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Headache, Disorientation and Vaccination site pain, at an unspecified dose and frequency. At the time of the report, DISORIENTATION (disorientation) and VACCINATION SITE PAIN (sore arm) outcome was unknown and HEADACHE (Persistent headache) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medications details were not reported by the reporter.

Other Meds:

Current Illness:

ID: 1569992
Sex: F
Age:
State: PA

Vax Date: 03/18/2021
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: Temperature of 101; body aches; Bone hurts; Muscle Pain; This spontaneous case was reported by a consumer and describes the occurrence of BODY TEMPERATURE INCREASED (Temperature of 101), PAIN (body aches), BONE PAIN (Bone hurts) and MYALGIA (Muscle Pain) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 18-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BODY TEMPERATURE INCREASED (Temperature of 101), PAIN (body aches), BONE PAIN (Bone hurts) and MYALGIA (Muscle Pain). At the time of the report, BODY TEMPERATURE INCREASED (Temperature of 101), PAIN (body aches), BONE PAIN (Bone hurts) and MYALGIA (Muscle Pain) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101 (High) Temperature of 101. Action taken with mRNA-1273 Moderna COVID-19 Vaccination was Not applicable. No Concomitant medication was provided. No Treatment medication was provided.

Other Meds:

Current Illness:

ID: 1569993
Sex: F
Age: 72
State: WA

Vax Date: 03/11/2021
Onset Date: 03/11/2021
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: Unevaluable event

Symptoms: red rash at injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE RASH (red rash at injection site) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 11-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced INJECTION SITE RASH (red rash at injection site). On 14-Mar-2021, INJECTION SITE RASH (red rash at injection site) had resolved. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medication and treatment medication was not reported.

Other Meds:

Current Illness:

ID: 1569994
Sex: F
Age: 91
State: MS

Vax Date: 03/19/2021
Onset Date: 03/05/2021
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: Chills, Dizziness, Injection site pain, Myalgia, Pyrexia

Symptoms: injection site turned red; chills; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills) and VACCINATION SITE ERYTHEMA (injection site turned red) in a 91-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 19-Mar-2021, 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) and VACCINATION SITE ERYTHEMA (injection site turned red). At the time of the report, CHILLS (chills) and VACCINATION SITE ERYTHEMA (injection site turned red) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. The patient reported no past medical history or concurrent medical conditions. No treatment medications or concomitant medications reported.

Other Meds:

Current Illness:

ID: 1569995
Sex: F
Age: 38
State: NJ

Vax Date: 01/08/2021
Onset Date: 01/08/2021
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: Maternal exposure during breast feeding; Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) and MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding) in a 38-year-old female patient (gravida 1, para 0) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031l20a and 012l20a) for COVID-19 vaccination. The patient's past medical history included Alcoholic. Family history included Hirschsprung's disease (Patient's brother had Hirschsprung's disease history was reported.). Concurrent medical conditions included Sulfonamide allergy and Hypothyroidism since 17-Dec-2020. Concomitant products included LEVOTHYROXINE from 17-Dec-2020 to an unknown date for Hypothyroidism. On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 27-Aug-2020 and the estimated date of delivery was 22-May-2021. On 08-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). On an unknown date, the patient experienced MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the thirty-ninth week of the pregnancy. The vaginal delivery occurred on 24-May-2021, which was reported as Full-term. For neonate 1, the birth weight was 3350 grams (7lbs 6oz) with an APGAR score of 8 and 9 at (1, 5 minutes). The outcome was reported as Delivered NOS. fetus height 53.34 cm and 39 weeks of gestation was reported. On 08-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved. At the time of the report, MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Oct-2020, Pregnancy test: Positive. Concomitant product used included prenatal gummy medications which is taking orally from 01 Oct 2020 for pregnancy.Fetus detail includes identified infant abnormalities at 1 month post-partum laryngeal malacia was reported.Pregnancy related complications included hypothyroidism. No treatment information was provided. Most recent FOLLOW-UP information incorporated above includes: On 28-Jul-2021: Significant Follow-up contains pregnancy information,allergy,Pregnancy test,LMP date,height and weight race of the patient,fetus details, family history and best doctor information and concomitant products.

Other Meds: LEVOTHYROXINE

Current Illness: Hypothyroidism; Sulfonamide allergy

ID: 1569996
Sex: U
Age:
State: CO

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: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site pain, Menorrhagia

Symptoms: 16 year old; A spontaneous report was received from a Pharmacist concerning a 16 years old patient of unspecified gender who received Moderna's COVID-19 vaccine. The patient's medical history was not reported. Concomitant medications were not provided by the reporter. On an unspecified date, prior to the onset of events, the patient received the first unplanned dose of mRNA-1273 (lot number: unknown) via Intramuscular route for the prophylaxis of COVID-19 infection. No treatment medication was reported. Action taken with mRNA-1273 in response to the event was unknown. The outcome of the event was resolved at the time of this report.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age (16 year old) for mRNA-1273 (lot number unknown) with no associated AEs reported.

Other Meds:

Current Illness:

ID: 1569997
Sex: F
Age:
State: MD

Vax Date: 03/02/2021
Onset Date: 03/09/2021
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: Itchy rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Itchy rash) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination. No medical history was provided by the reporter. Concomitant products included RAMIPRIL (ALTACE), ESOMEPRAZOLE SODIUM (NEXIUM [ESOMEPRAZOLE SODIUM]) and CLOPIDOGREL BISULFATE (PLAVIX) for an unknown indication. On 02-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) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced RASH PRURITIC (Itchy rash). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form and HYDROCORTISONE at a dose of 1 dosage form. At the time of the report, RASH PRURITIC (Itchy rash) had not resolved. Not Provided concomitant medications include OTC supplements. Treatment details included Benadryl, Hydrocortisone topical. Action taken with mRNA-1273 in response to the drug was not applicable. Most recent FOLLOW-UP information incorporated above includes: On 08-May-2021: Patient still have a rash despite dermatologist treatment , urgent care visit and visit to primary care physician.

Other Meds: ALTACE; NEXIUM [ESOMEPRAZOLE SODIUM]; PLAVIX

Current Illness:

ID: 1569998
Sex: M
Age:
State: GA

Vax Date:
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: Nausea, Pain in extremity, Pyrexia

Symptoms: Dosing error (pediatric use); A spontaneous report was received from a healthcare professional concerning a 17 year old patient who received first dose of Moderna's COVID-19 Vaccine (mRNA-1273) and experienced Product administered to patient of inappropriate age. The patient's medical history, was not provided. Concomitant product use was not provided by the reporter. On an unknown date, the patient received the first of two planned doses of mRNA-1273 (Batch number: 023M20A) intramuscularly for prophylaxis of COVID-19 infection. On an unknown date, the patient experienced the event Product administered to patient of inappropriate age. No treatment information was provided. Action taken with mRNA-1273 in response to the events was unknown. The outcome of the event, Product administered to patient of inappropriate age, was considered resolved.; Sender's Comments: This report refers to a case of Product Administered to Patient of Inappropriate Age for mRNA-1273 (Lot number: 023M20A) with no associated AEs.

Other Meds:

Current Illness:

ID: 1569999
Sex: U
Age:
State: MS

Vax Date: 03/18/2021
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: RA

Lab Data:

Allergies:

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: vomiting; severe headache; nausea; diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (vomiting), HEADACHE (severe headache), NAUSEA (nausea) and DIARRHOEA (diarrhea) in a 68-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History Information was reported. On 18-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 an unknown date, the patient experienced VOMITING (vomiting), HEADACHE (severe headache), NAUSEA (nausea) and DIARRHOEA (diarrhea). At the time of the report, VOMITING (vomiting), HEADACHE (severe headache), NAUSEA (nausea) and DIARRHOEA (diarrhea) had not resolved. No relevant Concomitant medications were reported. No Treatment information for the event was provided. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 19-Mar-2021 and was forwarded to Moderna on 19-Mar-2021. This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (vomiting), HEADACHE (severe headache), NAUSEA (nausea) and DIARRHOEA (diarrhea) in a 68-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History Information was reported. On 18-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 an unknown date, the patient experienced VOMITING (vomiting), HEADACHE (severe headache), NAUSEA (nausea) and DIARRHOEA (diarrhea). At the time of the report, VOMITING (vomiting), HEADACHE (severe headache), NAUSEA (nausea) and DIARRHOEA (diarrhea) had not resolved. No relevant Concomitant medications were reported. No Treatment information for the event was provided.

Other Meds:

Current Illness:

ID: 1570000
Sex: F
Age: 65
State: NJ

Vax Date: 01/26/2021
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: RA

Lab Data:

Allergies:

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

Symptoms: warm; scratchy throat; stuffy nose; thick mucus; tired; muscle pain; headaches; chills; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (warm), OROPHARYNGEAL DISCOMFORT (scratchy throat), DYSPNOEA (stuffy nose), INCREASED VISCOSITY OF UPPER RESPIRATORY SECRETION (thick mucus) and FATIGUE (tired) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20A and 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Seasonal allergy. Concomitant products included NAPROXEN for Back pain and Back pain, ENALAPRIL for Blood pressure. On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-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 FEELING HOT (warm), OROPHARYNGEAL DISCOMFORT (scratchy throat), DYSPNOEA (stuffy nose), INCREASED VISCOSITY OF UPPER RESPIRATORY SECRETION (thick mucus), FATIGUE (tired), MYALGIA (muscle pain), HEADACHE (headaches) and CHILLS (chills). At the time of the report, FEELING HOT (warm), OROPHARYNGEAL DISCOMFORT (scratchy throat), DYSPNOEA (stuffy nose), INCREASED VISCOSITY OF UPPER RESPIRATORY SECRETION (thick mucus), FATIGUE (tired), MYALGIA (muscle pain), HEADACHE (headaches) and CHILLS (chills) outcome was unknown. Patient has received Tylenol treatment for the symptoms. Action taken with mRNA-1273 in response to the event was not applicable.

Other Meds: NAPROXEN; ENALAPRIL

Current Illness: Seasonal allergy

ID: 1570001
Sex: F
Age:
State: TX

Vax Date: 02/22/2021
Onset Date: 02/22/2021
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: Pregnant patient received both doses of vaccine; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant patient received both doses of vaccine) in a female patient of an unknown age (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 22-Feb-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant patient received both doses of vaccine). On 19-Mar-2021, EXPOSURE DURING PREGNANCY (Pregnant patient received both doses of vaccine) had resolved. Not Provided Concomitant product use was not provided by the reporter. Treatment information was not provided.

Other Meds:

Current Illness:

ID: 1570002
Sex: F
Age:
State: PA

Vax Date: 03/17/2021
Onset Date: 03/17/2021
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: Injection site pain

Symptoms: chills; fever; fatigue; muscle pain; It's sort of having COVID again; sore arm - right arm; headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm - right arm), HEADACHE (headache), CHILLS (chills), PYREXIA (fever) and FATIGUE (fatigue) in a 70-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 COVID-19 in February 2021. Concurrent medical conditions included Arthritis rheumatoid. On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm - right arm) and HEADACHE (headache). On 18-Mar-2021, the patient experienced CHILLS (chills), PYREXIA (fever), FATIGUE (fatigue), MYALGIA (muscle pain) and COVID-19 (It's sort of having COVID again). The patient was treated with IBUPROFEN at an unspecified dose and frequency. On 19-Mar-2021, HEADACHE (headache), CHILLS (chills), PYREXIA (fever), FATIGUE (fatigue), MYALGIA (muscle pain) and COVID-19 (It's sort of having COVID again) had resolved. At the time of the report, PAIN IN EXTREMITY (sore arm - right arm) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Patient used ibuprofen as treatment medication. No concomitant medications were reported.

Other Meds:

Current Illness: Arthritis rheumatoid

ID: 1570003
Sex: F
Age: 67
State: IA

Vax Date: 02/17/2021
Onset Date: 02/17/2021
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 induration, Injection site pruritus, Injection site swelling, Injection site warmth

Symptoms: Freezing; Arm felt hot; Vomiting; Severe Headache; slight temperature; Chills; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), NASOPHARYNGITIS (Freezing), FEELING HOT (Arm felt hot), VOMITING (Vomiting) and HEADACHE (Severe Headache) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A and 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 18-Mar-2021, the patient experienced NASOPHARYNGITIS (Freezing), FEELING HOT (Arm felt hot), VOMITING (Vomiting), HEADACHE (Severe Headache), PYREXIA (slight temperature) and CHILLS (Chills). At the time of the report, PAIN IN EXTREMITY (Sore arm), NASOPHARYNGITIS (Freezing), FEELING HOT (Arm felt hot), VOMITING (Vomiting), HEADACHE (Severe Headache), PYREXIA (slight temperature) and CHILLS (Chills) outcome was unknown. Not Provided No concomitant medications reported. Treatment medications was not provided by the reporter Action taken with mRNA-1273 in response to the events was not applicable. This case was linked to MOD-2021-051543 (Patient Link).

Other Meds:

Current Illness:

ID: 1570004
Sex: F
Age: 36
State: MA

Vax Date: 03/10/2021
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: RA

Lab Data:

Allergies:

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

Symptoms: Loss of taste; Headache; Fever; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (Loss of taste), HEADACHE (Headache) and PYREXIA (Fever) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination. The patient's past medical history included No adverse event. On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced AGEUSIA (Loss of taste), HEADACHE (Headache) and PYREXIA (Fever). At the time of the report, AGEUSIA (Loss of taste), HEADACHE (Headache) and PYREXIA (Fever) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported. No laboratory details were provided. No treatment medications were reported.

Other Meds:

Current Illness:

ID: 1570005
Sex: F
Age: 69
State: WI

Vax Date: 02/19/2021
Onset Date: 03/18/2021
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: Tremor

Symptoms: severe rash on the left arm; Painful arm; itchy; did not want to receive the second dose; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE RASH (severe rash on the left arm), VACCINATION SITE PAIN (Painful arm), VACCINATION SITE PRURITUS (itchy) and INCOMPLETE COURSE OF VACCINATION (did not want to receive the second dose) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination. No Medical History information was reported. On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced INCOMPLETE COURSE OF VACCINATION (did not want to receive the second dose). On 19-Mar-2021, the patient experienced VACCINATION SITE RASH (severe rash on the left arm), VACCINATION SITE PAIN (Painful arm) and VACCINATION SITE PRURITUS (itchy). At the time of the report, VACCINATION SITE RASH (severe rash on the left arm), VACCINATION SITE PAIN (Painful arm) and VACCINATION SITE PRURITUS (itchy) outcome was unknown and INCOMPLETE COURSE OF VACCINATION (did not want to receive the second dose) had resolved. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications was included. Patient was treated with steroids.

Other Meds:

Current Illness:

ID: 1570006
Sex: F
Age:
State:

Vax Date: 03/09/2021
Onset Date:
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: Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea) 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 09-Mar-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 DIARRHOEA (Diarrhea). At the time of the report, DIARRHOEA (Diarrhea) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications reported by reporter. Treatment medication not reported. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1570007
Sex: M
Age:
State: IL

Vax Date: 03/09/2021
Onset Date: 03/09/2021
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: chills; nausea; tiredness; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), NAUSEA (nausea) and FATIGUE (tiredness) 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 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced CHILLS (chills), NAUSEA (nausea) and FATIGUE (tiredness). On 10-Mar-2021, CHILLS (chills), NAUSEA (nausea) and FATIGUE (tiredness) had resolved. 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.

Other Meds:

Current Illness:

ID: 1570008
Sex: F
Age: 38
State: MO

Vax Date: 01/26/2021
Onset Date: 01/26/2021
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: Cough, Limb discomfort, Pain, SARS-CoV-2 test positive

Symptoms: Second dose on more than 28 days; Pain and soreness at injection site; Received 1ml of Moderna Covid vaccine as 1st dose; This spontaneous case was reported by a nurse and describes the occurrence of OVERDOSE (Received 1ml of Moderna Covid vaccine as 1st dose), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose on more than 28 days) and INJECTION SITE PAIN (Pain and soreness at injection site) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 044A21A) for COVID-19 vaccination. Concurrent medical conditions included Drug allergy (compazine ), Drug allergy (vancomycin ) and Drug allergy (doxycycline). On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 ml. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Jan-2021, the patient experienced OVERDOSE (Received 1ml of Moderna Covid vaccine as 1st dose) and INJECTION SITE PAIN (Pain and soreness at injection site). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose on more than 28 days). The patient was treated with IBUPROFEN ongoing since an unknown date for Symptomatic treatment, at an unspecified dose and frequency. On 26-Jan-2021, OVERDOSE (Received 1ml of Moderna Covid vaccine as 1st dose) had resolved. On 29-Jan-2021, INJECTION SITE PAIN (Pain and soreness at injection site) had resolved. At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose on more than 28 days) 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.

Other Meds:

Current Illness: Drug allergy (vancomycin); Drug allergy (doxycycline); Drug allergy (compazine)

ID: 1570009
Sex: M
Age:
State: FL

Vax Date:
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: Asthenia, Chills, Headache, Myalgia

Symptoms: dizziness; weakness.; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness) and ASTHENIA (weakness.) 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 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 DIZZINESS (dizziness) and ASTHENIA (weakness.). At the time of the report, DIZZINESS (dizziness) and ASTHENIA (weakness.) had not resolved. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were reported. No treatment medications were provided by the reporter. Most recent FOLLOW-UP information incorporated above includes: On 30-Mar-2021: Patient demographics, outcome of events updated On 11-May-2021: No new information

Other Meds:

Current Illness:

ID: 1570010
Sex: F
Age:
State: CA

Vax Date: 03/11/2021
Onset Date: 03/11/2021
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: itchiness redness and hardness in the injection site; itchiness redness and hardness in the injection site; itchiness redness and hardness in the injection site; metallic/chemical taste in mouth; heart beat real fast; visual changes; lightheaded; the veins in both hands were quite large, bulging; super nauseated; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (metallic/chemical taste in mouth), HEART RATE INCREASED (heart beat real fast), OCULAR DISCOMFORT (visual changes), DIZZINESS (lightheaded) and VASODILATATION (the veins in both hands were quite large, bulging) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Anaphylaxis (Anaphylaxis to Ibuprofen, penicillin, aspirin). On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced DYSGEUSIA (metallic/chemical taste in mouth), HEART RATE INCREASED (heart beat real fast), OCULAR DISCOMFORT (visual changes), DIZZINESS (lightheaded), VASODILATATION (the veins in both hands were quite large, bulging) and NAUSEA (super nauseated). On 18-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (itchiness redness and hardness in the injection site), VACCINATION SITE ERYTHEMA (itchiness redness and hardness in the injection site) and VACCINATION SITE INDURATION (itchiness redness and hardness in the injection site). At the time of the report, DYSGEUSIA (metallic/chemical taste in mouth), HEART RATE INCREASED (heart beat real fast), OCULAR DISCOMFORT (visual changes), DIZZINESS (lightheaded), VASODILATATION (the veins in both hands were quite large, bulging), NAUSEA (super nauseated), VACCINATION SITE PRURITUS (itchiness redness and hardness in the injection site), VACCINATION SITE ERYTHEMA (itchiness redness and hardness in the injection site) and VACCINATION SITE INDURATION (itchiness redness and hardness in the injection site) 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 provided. No treatment medications were reported. Patient was pre-medicated with antihistamine.

Other Meds:

Current Illness:

ID: 1570011
Sex: F
Age: 60
State: FL

Vax Date: 03/11/2021
Onset Date: 03/11/2021
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: Injection site redness (deep redness); Injection site tenderness; injection site itching; Body ache; headache; Injection site tenderness; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body ache), HEADACHE (headache), the first episode of INJECTION SITE PAIN (Injection site tenderness), FATIGUE (fatigue) and VACCINATION SITE ERYTHEMA (Injection site redness (deep redness)) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced PAIN (Body ache), HEADACHE (headache), the first episode of INJECTION SITE PAIN (Injection site tenderness) and FATIGUE (fatigue). On 19-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (Injection site redness (deep redness)), the second episode of INJECTION SITE PAIN (Injection site tenderness) and INJECTION SITE PRURITUS (injection site itching). At the time of the report, PAIN (Body ache), HEADACHE (headache), FATIGUE (fatigue), VACCINATION SITE ERYTHEMA (Injection site redness (deep redness)), the last episode of INJECTION SITE PAIN (Injection site tenderness) and INJECTION SITE PRURITUS (injection site itching) 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. Treatment information was not provided. Lab details were not provided.

Other Meds:

Current Illness:

ID: 1570012
Sex: F
Age: 62
State:

Vax Date: 02/26/2021
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: Pain in extremity

Symptoms: Dizziness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included Pulmonary arterial hypertension. Concomitant products included TREPROSTINIL SODIUM (REMODULIN) from 02-Feb-2021 to an unknown date for an unknown indication. On 26-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced DIZZINESS (Dizziness). At the time of the report, DIZZINESS (Dizziness) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Reporter did not allow further contact

Other Meds: REMODULIN

Current Illness:

ID: 1570013
Sex: M
Age: 57
State: RI

Vax Date: 03/05/2021
Onset Date: 03/18/2021
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: Arm hurts more; less range of motion; elbow feels tight; stiffness in left shoulder and arm; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 19-Mar-2021 and was forwarded to Moderna on 19-Mar-2021. This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (stiffness in left shoulder and arm), LIMB DISCOMFORT (Arm hurts more), JOINT RANGE OF MOTION DECREASED (less range of motion) and ARTHRALGIA (elbow feels tight) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination. No reported medical history. On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (stiffness in left shoulder and arm). On 19-Mar-2021, the patient experienced LIMB DISCOMFORT (Arm hurts more), JOINT RANGE OF MOTION DECREASED (less range of motion) and ARTHRALGIA (elbow feels tight). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) at a dose of 1 dosage form. At the time of the report, MUSCULOSKELETAL STIFFNESS (stiffness in left shoulder and arm), LIMB DISCOMFORT (Arm hurts more), JOINT RANGE OF MOTION DECREASED (less range of motion) and ARTHRALGIA (elbow feels tight) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant information was not provided. Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: Follow-up information received on 18-May-2021 contains non-significant information.

Other Meds:

Current Illness:

ID: 1570014
Sex: F
Age: 55
State: PA

Vax Date: 03/15/2021
Onset Date: 03/15/2021
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: feel Sleepy; Feeling tired; Soreness of Right arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness of Right arm), SOMNOLENCE (feel Sleepy) and FATIGUE (Feeling tired) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. Concurrent medical conditions included Blood pressure and Diabetes. Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) and VITAMINS NOS for an unknown indication. On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced PAIN IN EXTREMITY (Soreness of Right arm). On 16-Mar-2021, the patient experienced SOMNOLENCE (feel Sleepy) and FATIGUE (Feeling tired). At the time of the report, PAIN IN EXTREMITY (Soreness of Right arm), SOMNOLENCE (feel Sleepy) and FATIGUE (Feeling tired) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Additional concomitant medications included unspecified medicines for blood pressure and diabetes. Patient did not take any treatment for the symptoms. Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: Follow up received: No new information.

Other Meds: ASPIRIN (E.C.); VITAMINS NOS

Current Illness: Blood pressure; Diabetes

ID: 1570015
Sex: F
Age: 49
State: MS

Vax Date: 02/03/2021
Onset Date: 02/03/2021
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: This spontaneous case was reported by a nurse and describes the occurrence of ASTHENIA (Loss of Energy), HEADACHE (Headache), NAUSEA (NAUSEA), CHILLS (Chills) and PYREXIA (Low grade fever) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L28) for COVID-19 vaccination. The patient's past medical history included no adverse drug effect. On 03-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 03-Feb-2021, the patient experienced ASTHENIA (Loss of Energy), HEADACHE (Headache), NAUSEA (NAUSEA), CHILLS (Chills) and PYREXIA (Low grade fever). In February 2021, ASTHENIA (Loss of Energy), HEADACHE (Headache), NAUSEA (NAUSEA), CHILLS (Chills) and PYREXIA (Low grade fever) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. There is no concomitants drugs information was provided. No treatment information provided.

Other Meds:

Current Illness:

ID: 1570016
Sex: M
Age:
State: CA

Vax Date: 03/18/2021
Onset Date: 03/19/2021
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: cold sores flared up on lips; Nausea; Fever; Intense pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Intense pain), ORAL HERPES (cold sores flared up on lips), NAUSEA (Nausea) and PYREXIA (Fever) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. Concurrent medical conditions included Multiple sclerosis. On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced PAIN (Intense pain), NAUSEA (Nausea) and PYREXIA (Fever). On 21-Mar-2021, the patient experienced ORAL HERPES (cold sores flared up on lips). At the time of the report, PAIN (Intense pain), ORAL HERPES (cold sores flared up on lips), NAUSEA (Nausea) and PYREXIA (Fever) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product use was not provided. Treatment information was not provided. Reporter did not allow further contact

Other Meds:

Current Illness: Multiple sclerosis

ID: 1570017
Sex: M
Age:
State: WI

Vax Date: 02/09/2021
Onset Date: 01/01/2021
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: This spontaneous case was reported by a pharmacist and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Pfizer Dose One) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included No adverse event (No relevant medical history reported). On 09-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Jan-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Pfizer Dose One). On 01-Jan-2021, INTERCHANGE OF VACCINE PRODUCTS (Pfizer Dose One) had resolved. 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. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1570018
Sex: F
Age: 65
State: NY

Vax Date: 03/07/2021
Onset Date: 03/01/2021
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: Abnormal Lymph Nodes under right arm; Tingling sensation in both feet; Numbness in all toes; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Abnormal Lymph Nodes under right arm), PARAESTHESIA (Tingling sensation in both feet) and HYPOAESTHESIA (Numbness in all toes) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. No Medical History information was reported. On 07-Mar-2021 at 11:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced PARAESTHESIA (Tingling sensation in both feet) and HYPOAESTHESIA (Numbness in all toes). On 16-Mar-2021 at 2:15 PM, the patient experienced LYMPHADENOPATHY (Abnormal Lymph Nodes under right arm). At the time of the report, LYMPHADENOPATHY (Abnormal Lymph Nodes under right arm), PARAESTHESIA (Tingling sensation in both feet) and HYPOAESTHESIA (Numbness in all toes) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Mar-2021, Magnetic resonance imaging: abnormal (abnormal) abnormal lymph nodes under my right arm. On 16-Mar-2021, Mammogram: abnormal (abnormal) abnormality. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged. No concomitant medication was reported. The treatment information was unknown. Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: Follow-up information was received on 18-May-2021 contains information regarding the reporter, the patient's demographics, and the outcome of the events.

Other Meds:

Current Illness:

ID: 1570019
Sex: F
Age: 65
State: WA

Vax Date: 03/18/2021
Onset Date: 03/01/2021
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: This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm for a couple of days no other reaction it wasn't extremely sore nor unbearable), PAIN (has a degenerative joint disease and has pain in her neck and right shoulder), ARTHRALGIA (bad pain on her knee which has arthritis), FATIGUE (tiredness and fatigue) and FATIGUE (tired) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination. Concurrent medical conditions included Degenerative joint disease and Seizure. On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced PAIN (has a degenerative joint disease and has pain in her neck and right shoulder), ARTHRALGIA (bad pain on her knee which has arthritis) and FATIGUE (tiredness and fatigue). On 18-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm for a couple of days no other reaction it wasn't extremely sore nor unbearable). On an unknown date, the patient experienced FATIGUE (tired). At the time of the report, PAIN IN EXTREMITY (sore arm for a couple of days no other reaction it wasn't extremely sore nor unbearable), PAIN (has a degenerative joint disease and has pain in her neck and right shoulder), ARTHRALGIA (bad pain on her knee which has arthritis), FATIGUE (tiredness and fatigue) and FATIGUE (tired) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No relevant concomitant medications were reported. No treatment information was provided. Most recent FOLLOW-UP information incorporated above includes: On 09-May-2021: Events were resolved and consumer consented to follow up via phone.

Other Meds:

Current Illness: Degenerative joint disease; Seizure

ID: 1570020
Sex: F
Age:
State: NC

Vax Date: 03/18/2021
Onset Date: 03/18/2021
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: 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. On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced HEADACHE (headache). At the time of the report, HEADACHE (headache) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment medication was taken. No concomitant medication was taken.

Other Meds:

Current Illness:

ID: 1570021
Sex: F
Age: 81
State: MI

Vax Date: 02/27/2021
Onset Date:
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: A vein had been hit, patient had a little bruise; It is extremely itchy; Rash 2 inches below injection site; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION (A vein had been hit, patient had a little bruise), VACCINATION SITE PRURITUS (It is extremely itchy), VACCINATION SITE RASH (Rash 2 inches below injection site) and VACCINATION SITE PAIN (Sore arm) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination. Concurrent medical conditions included Scoliosis and Asthma. Concomitant products included NAPROXEN (MOTRIN [NAPROXEN]), OXYCODONE, METFORMIN, VENLAFAXINE, LOSARTAN, ATORVASTATIN CALCIUM (LIPITOR), METOPROLOL and FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) for an unknown indication. On 27-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 CONTUSION (A vein had been hit, patient had a little bruise), VACCINATION SITE PRURITUS (It is extremely itchy), VACCINATION SITE RASH (Rash 2 inches below injection site) and VACCINATION SITE PAIN (Sore arm). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, CONTUSION (A vein had been hit, patient had a little bruise), VACCINATION SITE PRURITUS (It is extremely itchy), VACCINATION SITE RASH (Rash 2 inches below injection site) and VACCINATION SITE PAIN (Sore arm) 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: MOTRIN [NAPROXEN]; OXYCODONE; METFORMIN; VENLAFAXINE; LOSARTAN; LIPITOR; METOPROLOL; ADVAIR

Current Illness: Asthma; Scoliosis

Total 2021 VAERS Injuries: 636,615

Page last modified: 03 October 2021 5:28pm