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: 1558983
Sex: M
Age: 85
State: FL

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: LA

Lab Data:

Allergies:

Symptom List: Dysphagia, Epiglottitis

Symptoms: Just a little soreness on the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Just a little soreness on the injection site) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. Concurrent medical conditions included Ulcerative colitis (in remission) since 15-Sep-2018. Concomitant products included BUDESONIDE from 01-Oct-2018 to an unknown date for Diarrhea. On 27-Feb-2021 at 5:00 PM, 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 PAIN (Just a little soreness on the injection site). At the time of the report, VACCINATION SITE PAIN (Just a little soreness on the injection site) was resolving. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment medication was reported. Most recent FOLLOW-UP information incorporated above includes: On 01-May-2021: Reporter Information updated, Patient Medical History and Concomitant Medications added,

Other Meds: BUDESONIDE

Current Illness: Ulcerative colitis (in remission)

ID: 1558984
Sex: U
Age:
State: NC

Vax Date: 02/25/2021
Onset Date: 02/26/2021
Rec V Date: 08/15/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025L20A
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Anxiety, Dyspnoea

Symptoms: WOKE UP WITH A TREMENDOUS HEADACHE; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (WOKE UP WITH A TREMENDOUS HEADACHE) 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 25-Feb-2021 at 10:15 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced HEADACHE (WOKE UP WITH A TREMENDOUS HEADACHE). At the time of the report, HEADACHE (WOKE UP WITH A TREMENDOUS HEADACHE) had not resolved. No treatment information provided.

Other Meds:

Current Illness:

ID: 1558985
Sex: F
Age: 75
State:

Vax Date: 02/23/2021
Onset Date: 02/26/2021
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: shingles in her scalp; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HERPES ZOSTER (shingles in her scalp) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. No Medical History information 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 dosage form. On 26-Feb-2021, the patient experienced HERPES ZOSTER (shingles in her scalp). The patient was treated with VALACICLOVIR HYDROCHLORIDE (VALACYCLOVIR HCL) for Adverse event, at a dose of UNK dosage form. At the time of the report, HERPES ZOSTER (shingles in her scalp) outcome was unknown. No concomitant medication were provided Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: Follow received on 29-APR-2021 : Consumer declined Consent.

Other Meds:

Current Illness:

ID: 1558986
Sex: F
Age: 35
State: NM

Vax Date: 02/25/2021
Onset Date: 02/25/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No medical history was provided and concomitant drugs are provided. Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication. On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was in August 2020 and the estimated date of delivery was 04-May-2021. On 25-Feb-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy. On 25-Feb-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. This case was linked to MOD-2021-102237 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: NNI

Other Meds: PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]

Current Illness:

ID: 1558987
Sex: M
Age: 65
State: FL

Vax Date: 02/25/2021
Onset Date: 02/25/2021
Rec V Date: 08/15/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 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: Exacerbate his symptoms from his back surgery; Back pain; Leg Spasms; Increased back spasms; Achiness; Dizziness; Chills; Nausea; Headache; Fever of 99.2 F; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Exacerbate his symptoms from his back surgery), BACK PAIN (Back pain), MUSCLE SPASMS (Leg Spasms), MUSCLE SPASMS (Increased back spasms) and PAIN (Achiness) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19 in November 2020 and Spinal stenosis (Multiple surgeries conducted NOS). Concomitant products included GABAPENTIN and MELOXICAM for an unknown indication. 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 VACCINATION COMPLICATION (Exacerbate his symptoms from his back surgery), BACK PAIN (Back pain), MUSCLE SPASMS (Leg Spasms), MUSCLE SPASMS (Increased back spasms), PAIN (Achiness), DIZZINESS (Dizziness), CHILLS (Chills), NAUSEA (Nausea), HEADACHE (Headache) and PYREXIA (Fever of 99.2 F). At the time of the report, VACCINATION COMPLICATION (Exacerbate his symptoms from his back surgery), BACK PAIN (Back pain), MUSCLE SPASMS (Leg Spasms), MUSCLE SPASMS (Increased back spasms), PAIN (Achiness), DIZZINESS (Dizziness), CHILLS (Chills), NAUSEA (Nausea), HEADACHE (Headache) and PYREXIA (Fever of 99.2 F) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2020, Body temperature: 99.2 (Inconclusive) 99.2. In November 2020, SARS-CoV-2 test positive: Positive. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.

Other Meds: GABAPENTIN; MELOXICAM

Current Illness:

ID: 1558988
Sex: F
Age: 68
State:

Vax Date: 02/26/2021
Onset Date: 02/26/2021
Rec V Date: 08/15/2021
Hospital:

Vax Type: FLUC4
Manufacturer: SEQIRUS, INC.
Vax Name: INFLUENZA (SEASONAL) (FLUCELVAX QUADRIVALENT)
Lot: 276563
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

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

Symptoms: itch a lot; rash on right arm, and a little bit on left one as well, and mainly on back; swelling of the injection site; red circle around the area the size of a baseball; lump/knot in the injection site; This spontaneous case was reported by a health care professional and describes the occurrence of INJECTION SITE MASS (lump/knot in the injection site), PRURITUS (itch a lot), RASH (rash on right arm, and a little bit on left one as well, and mainly on back), VACCINATION SITE SWELLING (swelling of the injection site) and VACCINATION SITE ERYTHEMA (red circle around the area the size of a baseball) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) 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 MASS (lump/knot in the injection site), VACCINATION SITE SWELLING (swelling of the injection site) and VACCINATION SITE ERYTHEMA (red circle around the area the size of a baseball). On 02-Mar-2021, the patient experienced PRURITUS (itch a lot) and RASH (rash on right arm, and a little bit on left one as well, and mainly on back). On 02-Mar-2021, VACCINATION SITE SWELLING (swelling of the injection site) had resolved. At the time of the report, INJECTION SITE MASS (lump/knot in the injection site), PRURITUS (itch a lot), RASH (rash on right arm, and a little bit on left one as well, and mainly on back) and VACCINATION SITE ERYTHEMA (red circle around the area the size of a baseball) had not 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 Most recent FOLLOW-UP information incorporated above includes: On 09-Mar-2021: No specific follow-up information recorded.

Other Meds:

Current Illness:

ID: 1558989
Sex: F
Age: 72
State: TX

Vax Date: 01/27/2021
Onset Date: 02/03/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Pyrexia, White blood cell count decreased

Symptoms: Sore Armpit (Injected Arm); Sore breast on movement; Sore Shoulder (Injected Arm); This spontaneous case was reported by a consumer and describes the occurrence of AXILLARY PAIN (Sore Armpit (Injected Arm)), BREAST PAIN (Sore breast on movement) and ARTHRALGIA (Sore Shoulder (Injected Arm)) in a 73-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. On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced AXILLARY PAIN (Sore Armpit (Injected Arm)), BREAST PAIN (Sore breast on movement) and ARTHRALGIA (Sore Shoulder (Injected Arm)). At the time of the report, AXILLARY PAIN (Sore Armpit (Injected Arm)), BREAST PAIN (Sore breast on movement) and ARTHRALGIA (Sore Shoulder (Injected Arm)) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were given No treatment information was provided

Other Meds:

Current Illness:

ID: 1558990
Sex: F
Age: 84
State: NJ

Vax Date: 02/23/2021
Onset Date: 02/24/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Pharyngeal swelling

Symptoms: rm was just a little red below the injection site after first dose; rm was just a little red below the injection site after first dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (rm was just a little red below the injection site after first dose) and VACCINATION SITE BRUISING (rm was just a little red below the injection site after first dose) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 032L20A) for COVID-19 vaccination. No Medical History information was reported. On 23-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) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced VACCINATION SITE BRUISING (rm was just a little red below the injection site after first dose). On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (rm was just a little red below the injection site after first dose). At the time of the report, VACCINATION SITE ERYTHEMA (rm was just a little red below the injection site after first dose) and VACCINATION SITE BRUISING (rm was just a little red below the injection site after first dose) outcome was unknown. Not Provided No treatment information was provided. This case was linked to MOD-2021-028240 (Patient Link).

Other Meds:

Current Illness:

ID: 1558991
Sex: F
Age:
State: OH

Vax Date: 02/26/2021
Onset Date: 02/26/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Abdominal pain, Chills, Sleep disorder

Symptoms: Have a fatty tumor and think that they shot it in there instead of in muscle; A spontaneous report was received from a consumer concerning a female patient of unspecified age, who received Moderna's COVID-19 vaccine and instead of putting the shot into the muscle, the patient had a fatty tumor and think that they shot it in there. The patient's medical history was not provided. No relevant concomitant medications were reported. On 26 Feb 2021, prior to the onset of events, the patient's received their first of two planned doses of mRNA-1273 (Batch number: unknown) for prophylaxis of Covid-19 infection. On 26 Feb 2021, after she received the vaccine, the patient reported instead of putting the shot into the muscle, the patient had a fatty tumor and think that they shot it in there. No treatment information was provided. Action taken with mRNA-1273 in response to the event was unknown. The outcome of the event, instead of putting the shot into their muscle, they have a fatty tumor and think they shot it in there was considered as resolved.; Reporter's Comments: This report refers to a case of incorrect dose administered for mRNA-1273 (lot # unknown) with no associated AEs reported.

Other Meds:

Current Illness:

ID: 1558992
Sex: F
Age:
State:

Vax Date: 01/18/2021
Onset Date: 01/27/2021
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: little tender to touch; a red rash at the injection site; felt warm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (little tender to touch), VACCINATION SITE RASH (a red rash at the injection site) and VACCINATION SITE WARMTH (felt warm) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, the patient experienced VACCINATION SITE PAIN (little tender to touch), VACCINATION SITE RASH (a red rash at the injection site) and VACCINATION SITE WARMTH (felt warm). At the time of the report, VACCINATION SITE PAIN (little tender to touch), VACCINATION SITE RASH (a red rash at the injection site) and VACCINATION SITE WARMTH (felt warm) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.

Other Meds:

Current Illness:

ID: 1558993
Sex: F
Age: 73
State: MI

Vax Date: 02/05/2021
Onset Date: 02/05/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling

Symptoms: was taken to ER and given some treatment; Itchy; Hives, ended up spread in many parts of her body,; This spontaneous case was reported by a consumer and describes the occurrence of EMERGENCY CARE (was taken to ER and given some treatment), PRURITUS (Itchy) and URTICARIA (Hives, ended up spread in many parts of her body,) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination. Concurrent medical conditions included Cholesterol, Thyroid disorder NOS and Thrombocythemia. On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, the patient experienced EMERGENCY CARE (was taken to ER and given some treatment), PRURITUS (Itchy) and URTICARIA (Hives, ended up spread in many parts of her body,). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 UNK and PREDNISONE at an unspecified dose and frequency. At the time of the report, EMERGENCY CARE (was taken to ER and given some treatment), PRURITUS (Itchy) and URTICARIA (Hives, ended up spread in many parts of her body,) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Patient was given steroid injection,Benadryl injection and prednisone pills as a treatment medication. Concomitant Medication included unspecified cholesterol medication , thyroid medication, quimo drug pill for type. It was reported that that the patient had many problems after she had the shot and it was unknown if it was related to the shot. Her problems lasted for 3 months. Most recent FOLLOW-UP information incorporated above includes: On 21-Jun-2021: F/U received on 21-JUN-2021,Clinical course information and event outcome updated.

Other Meds:

Current Illness: Cholesterol; Thrombocythemia; Thyroid disorder NOS

ID: 1558994
Sex: F
Age:
State:

Vax Date: 02/26/2021
Onset Date: 02/26/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Rash, Urticaria

Symptoms: Didn't sleep all night; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Didn't sleep all night) 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 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 INSOMNIA (Didn't sleep all night). At the time of the report, INSOMNIA (Didn't sleep all night) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.

Other Meds:

Current Illness:

ID: 1558995
Sex: F
Age: 61
State: LA

Vax Date: 02/07/2021
Onset Date: 02/07/2021
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: headache; 99.8?F low grade fever; Pain at injection site; Chills; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), PYREXIA (99.8?F low grade fever), VACCINATION SITE PAIN (Pain at injection site) and CHILLS (Chills) 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 07-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Feb-2021, the patient experienced HEADACHE (headache), PYREXIA (99.8?F low grade fever), VACCINATION SITE PAIN (Pain at injection site) and CHILLS (Chills). At the time of the report, HEADACHE (headache), PYREXIA (99.8?F low grade fever), VACCINATION SITE PAIN (Pain at injection site) and CHILLS (Chills) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Feb-2021, Body temperature: (Low) Low grade fever 99.8 F. This case was linked to MOD-2021-046584 (Patient Link).

Other Meds:

Current Illness:

ID: 1558996
Sex: F
Age: 37
State:

Vax Date: 02/01/2021
Onset Date: 02/01/2021
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: SYR
Vax Site: LA

Lab Data:

Allergies:

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

Symptoms: Bump/ball the size of a quarter size not raised; Itchy; Slight soreness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Bump/ball the size of a quarter size not raised), VACCINATION SITE PRURITUS (Itchy) and VACCINATION SITE PAIN (Slight soreness) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. no medical history is provided and concomitant drugs are provided. Concomitant products included IRON and PANTOPRAZOLE for an unknown indication. On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced VACCINATION SITE PAIN (Slight soreness). On 09-Feb-2021, the patient experienced VACCINATION SITE MASS (Bump/ball the size of a quarter size not raised) and VACCINATION SITE PRURITUS (Itchy). On 02-Feb-2021, VACCINATION SITE MASS (Bump/ball the size of a quarter size not raised) outcome was unknown, VACCINATION SITE PAIN (Slight soreness) had resolved. At the time of the report, VACCINATION SITE PRURITUS (Itchy) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.

Other Meds: IRON; PANTOPRAZOLE

Current Illness:

ID: 1558997
Sex: F
Age: 73
State: NY

Vax Date: 02/27/2021
Onset Date: 02/27/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (vaccination site pain) in a 73-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 27-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 VACCINATION SITE PAIN (vaccination site pain). At the time of the report, VACCINATION SITE PAIN (vaccination site pain) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medication information was not provided. Treatment provided was unknown. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1558998
Sex: F
Age: 65
State: CA

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

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Nausea, Pain, Pain in extremity, Paraesthesia oral, Pyrexia

Symptoms: flu like symptoms; nausea; chills; body aches; fatigue; fever; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (nausea), CHILLS (chills), MYALGIA (body aches), FATIGUE (fatigue) and PYREXIA (fever) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included LEVOTHYROXINE and PROGESTERONE for an unknown indication, ESTRADIOL (ESTRADOT). On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced NAUSEA (nausea), CHILLS (chills), MYALGIA (body aches), FATIGUE (fatigue) and PYREXIA (fever). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms). At the time of the report, NAUSEA (nausea), CHILLS (chills), MYALGIA (body aches), FATIGUE (fatigue), PYREXIA (fever) and INFLUENZA LIKE ILLNESS (flu like symptoms) 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 information not provided.

Other Meds: LEVOTHYROXINE; ESTRADOT; PROGESTERONE

Current Illness:

ID: 1558999
Sex: F
Age: 41
State: CT

Vax Date: 01/04/2021
Onset Date:
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: couldn't get the second dose; A spontaneous report was received from a HCP concerning about a 41 years old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced medication error of missed the second dose. The patient's medical history was not reported. Concomitant medications were not reported. On 04 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch number:026L20A) via intramuscular in left arm for prophylaxis of COVID-19 infection. On an unknown date in the month of Feb 2021, the patient realized that she missed her second dose of vaccination as she had to leave the country. Laboratory tests was not reported. Treatment information was not provided. All the events occurred after first dose of vaccination. Action taken with mRNA-1273 in response to the events are unknown. The outcome of event not applicable; Reporter's Comments: This report refers to a case of missed second dose of mRNA-1273 unintentionally, with no associated AEs. Causality for the medication error is not applicable.

Other Meds:

Current Illness:

ID: 1559000
Sex: F
Age: 80
State: MD

Vax Date: 02/10/2021
Onset Date: 02/10/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Ear pain, Hypoaesthesia

Symptoms: arm was red; arm was hot; arm was swollen; there was a rash on their neck in the side where they got the vaccine with redness on it; itching a lot on their back and ear and the palm of their hand; very very tired, terribly fatigued; it was like a hive on their upper lip; ears started itching; threw up some liquid that night; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (it was like a hive on their upper lip), EAR PRURITUS (ears started itching), ERYTHEMA (arm was red), FEELING HOT (arm was hot) and PERIPHERAL SWELLING (arm was swollen) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Seafood allergy (shellfish), Seasonal allergy (Seasonal) and Allergy to plants (Christmas trees). Concomitant products included LISINOPRIL, FAMOTIDINE, CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) and PROBIOTICS NOS for an unknown indication. On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced URTICARIA (it was like a hive on their upper lip), EAR PRURITUS (ears started itching) and VOMITING (threw up some liquid that night). On 22-Feb-2021, the patient experienced ERYTHEMA (arm was red), FEELING HOT (arm was hot), PERIPHERAL SWELLING (arm was swollen), RASH ERYTHEMATOUS (there was a rash on their neck in the side where they got the vaccine with redness on it), PRURITUS (itching a lot on their back and ear and the palm of their hand) and FATIGUE (very very tired, terribly fatigued). The patient was treated with SERTRALINE HYDROCHLORIDE ongoing since an unknown date at an unspecified dose and frequency. On 10-Feb-2021, VOMITING (threw up some liquid that night) had resolved. At the time of the report, URTICARIA (it was like a hive on their upper lip), EAR PRURITUS (ears started itching), ERYTHEMA (arm was red), FEELING HOT (arm was hot), PERIPHERAL SWELLING (arm was swollen), RASH ERYTHEMATOUS (there was a rash on their neck in the side where they got the vaccine with redness on it), PRURITUS (itching a lot on their back and ear and the palm of their hand) and FATIGUE (very very tired, terribly fatigued) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. On 10-Feb-2021, the patient took (Sertaline) 30 minutes before getting the vaccine. Her doctor wanted her to have the Moderna vaccine since it was the least allergic one. No other treatment was reported. This case was linked to MOD-2021-028289 (Patient Link).

Other Meds: LISINOPRIL; FAMOTIDINE; VITAMIN D 2000; PROBIOTICS NOS

Current Illness: Allergy to plants (Christmas trees); Seafood allergy (shellfish); Seasonal allergy (Seasonal)

ID: 1559001
Sex: F
Age: 63
State: PA

Vax Date: 02/19/2021
Onset Date: 02/20/2021
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: headache; muscle pain; joint pain; chills; nausea; fever(100.8); headache; This spontaneous case was reported by a consumer and describes the occurrence of the first episode of HEADACHE (headache), MYALGIA (muscle pain), ARTHRALGIA (joint pain), CHILLS (chills) and NAUSEA (nausea) in a 63-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 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced the first episode of HEADACHE (headache), MYALGIA (muscle pain), ARTHRALGIA (joint pain), CHILLS (chills), NAUSEA (nausea), PYREXIA (fever(100.8)) and the second episode of HEADACHE (headache). The patient was treated with IBUPROFEN, PSEUDOEPHEDRINE HYDROCHLORIDE (MOTRIN COLD & FLU) for Adverse event, at a dose of UNK dosage form. On 20-Feb-2021, MYALGIA (muscle pain), ARTHRALGIA (joint pain), CHILLS (chills), NAUSEA (nausea), PYREXIA (fever(100.8)) and the last episode of HEADACHE (headache) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medication were reported.

Other Meds:

Current Illness:

ID: 1559002
Sex: F
Age: 73
State: TX

Vax Date: 01/20/2021
Onset Date: 02/24/2021
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: Bone pain; Tremors; difficulty breathing since her nose and throat seem stuffy; No appetite; no taste; Upper arm pain; nose and throat seem stuffy; fever; Body aches; Headache; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of BONE PAIN (Bone pain), TREMOR (Tremors), DYSPNOEA (difficulty breathing since her nose and throat seem stuffy), DECREASED APPETITE (No appetite) and AGEUSIA (no taste) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025L20A and 011m20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Food allergy (Lactose) and Colon cancer. On 20-Jan-2021 at 10:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021 at 10:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Feb-2021, the patient experienced BONE PAIN (Bone pain), TREMOR (Tremors), DYSPNOEA (difficulty breathing since her nose and throat seem stuffy), DECREASED APPETITE (No appetite), AGEUSIA (no taste), PAIN IN EXTREMITY (Upper arm pain), NASAL CONGESTION (nose and throat seem stuffy), PYREXIA (fever), MYALGIA (Body aches), HEADACHE (Headache) and FATIGUE (Fatigue). At the time of the report, BONE PAIN (Bone pain), TREMOR (Tremors), DYSPNOEA (difficulty breathing since her nose and throat seem stuffy), DECREASED APPETITE (No appetite), AGEUSIA (no taste), NASAL CONGESTION (nose and throat seem stuffy), PYREXIA (fever), MYALGIA (Body aches), HEADACHE (Headache) and FATIGUE (Fatigue) outcome was unknown and PAIN IN EXTREMITY (Upper arm pain) had not resolved. The patient did not take any concomitant medications. No treatment information was reported. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Most recent FOLLOW-UP information incorporated above includes: On 02-May-2021: Reporter address, patient demographics, medical history, first dose date and lot number, additional event, medically confim.

Other Meds:

Current Illness: Colon cancer; Food allergy (Lactose)

ID: 1559003
Sex: M
Age:
State: TX

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

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

Lab Data:

Allergies:

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

Symptoms: Rash all over the body; itchy rash all over the body; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (itchy rash all over the body) and RASH (Rash all over the body) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH PRURITIC (itchy rash all over the body) and RASH (Rash all over the body). At the time of the report, RASH PRURITIC (itchy rash all over the body) and RASH (Rash all over the body) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown. No concomitant medications reported. No treatment information provided.

Other Meds:

Current Illness:

ID: 1559004
Sex: F
Age: 67
State:

Vax Date: 02/06/2021
Onset Date: 02/06/2021
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: Heat at the injection site; Swollen arm; Bruising; Mild headache; felt itchiness and burning on and off on eyes; felt itchiness and burning on and off on eyes; Lightheadedness; Blurry vision; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Heat at the injection site), HEADACHE (Mild headache), EYE PRURITUS (felt itchiness and burning on and off on eyes), EYE IRRITATION (felt itchiness and burning on and off on eyes) and DIZZINESS (Lightheadedness) in a 67-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. Concurrent medical conditions included Glaucoma. Concomitant products included TIMOLOL for Glaucoma, LEVOTHYROXINE for an unknown indication. On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced HEADACHE (Mild headache), EYE PRURITUS (felt itchiness and burning on and off on eyes), EYE IRRITATION (felt itchiness and burning on and off on eyes), DIZZINESS (Lightheadedness) and VISION BLURRED (Blurry vision). On an unknown date, the patient experienced VACCINATION SITE WARMTH (Heat at the injection site), PERIPHERAL SWELLING (Swollen arm) and CONTUSION (Bruising). At the time of the report, VACCINATION SITE WARMTH (Heat at the injection site), EYE PRURITUS (felt itchiness and burning on and off on eyes), EYE IRRITATION (felt itchiness and burning on and off on eyes), DIZZINESS (Lightheadedness), PERIPHERAL SWELLING (Swollen arm) and CONTUSION (Bruising) outcome was unknown and HEADACHE (Mild headache) and VISION BLURRED (Blurry vision) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment information provided.

Other Meds: LEVOTHYROXINE; TIMOLOL

Current Illness: Glaucoma

ID: 1559005
Sex: F
Age: 67
State: FL

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

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

Lab Data:

Allergies:

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

Symptoms: Teeth hurt; dull headache; felt like she was going to die, she felt like a vegetable; Unable to get off the couch and couldn't open her windows; she couldn't think about moving; left arm started to feel sore; didn't feel well all through the night,she thinks it will kill her and is harming her body; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (left arm started to feel sore), VACCINATION COMPLICATION (didn't feel well all through the night,she thinks it will kill her and is harming her body), FEELING ABNORMAL (felt like she was going to die, she felt like a vegetable), MALAISE (Unable to get off the couch and couldn't open her windows) and ASTHENIA (she couldn't think about moving) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19 from 20-Nov-2020 to February 2021. Concomitant products included LEVOTHYROXINE for an unknown indication. On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced PAIN IN EXTREMITY (left arm started to feel sore) and VACCINATION COMPLICATION (didn't feel well all through the night,she thinks it will kill her and is harming her body). On 03-Mar-2021, the patient experienced FEELING ABNORMAL (felt like she was going to die, she felt like a vegetable), MALAISE (Unable to get off the couch and couldn't open her windows) and ASTHENIA (she couldn't think about moving). On 05-Mar-2021, the patient experienced TOOTHACHE (Teeth hurt) and HEADACHE (dull headache). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of UNK, every 4-6 hours. On 05-Mar-2021, PAIN IN EXTREMITY (left arm started to feel sore), VACCINATION COMPLICATION (didn't feel well all through the night,she thinks it will kill her and is harming her body), FEELING ABNORMAL (felt like she was going to die, she felt like a vegetable), MALAISE (Unable to get off the couch and couldn't open her windows) and ASTHENIA (she couldn't think about moving) had resolved. At the time of the report, TOOTHACHE (Teeth hurt) and HEADACHE (dull headache) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.

Other Meds: LEVOTHYROXINE

Current Illness:

ID: 1559006
Sex: F
Age: 68
State: MD

Vax Date: 02/02/2021
Onset Date: 02/02/2021
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: difficult to raise right arm; muscle soreness; hamstring muscle pain on left thigh; soreness and tenderness; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (soreness and tenderness), LIMB DISCOMFORT (difficult to raise right arm), MYALGIA (muscle soreness) and MYALGIA (hamstring muscle pain on left thigh) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination. No Medical History information was reported. 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 TENDERNESS (soreness and tenderness). On an unknown date, the patient experienced LIMB DISCOMFORT (difficult to raise right arm), MYALGIA (muscle soreness) and MYALGIA (hamstring muscle pain on left thigh). The patient was treated with IBUPROFEN (ADVIL 12 HOUR) for Adverse event, at a dose of UNK dosage form. At the time of the report, TENDERNESS (soreness and tenderness), LIMB DISCOMFORT (difficult to raise right arm), MYALGIA (muscle soreness) and MYALGIA (hamstring muscle pain on left thigh) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Patient also used a heating pad for treatment.

Other Meds:

Current Illness:

ID: 1559007
Sex: F
Age: 66
State: NY

Vax Date: 01/12/2021
Onset Date: 01/12/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site pain, Menorrhagia

Symptoms: sick and could not get out of bed/ sick for about 1.5 weeks; had a lump the size of a golf ball on her arm; heart was also racing again (like when she had COVID19) and her pulse was very fast.; As if I had COVID19 all over again; pulse was very fast; arm was also painful; fever of 102.7 F; headache; throat was dry; As if she was losing her voice; This spontaneous case was reported by a consumer and describes the occurrence of DRY THROAT (throat was dry), ILLNESS (sick and could not get out of bed/ sick for about 1.5 weeks), AXILLARY MASS (had a lump the size of a golf ball on her arm), PALPITATIONS (heart was also racing again (like when she had COVID19) and her pulse was very fast.) and COVID-19 (As if I had COVID19 all over again) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19 (Severe) in March 2020. Concurrent medical conditions included Asthma. On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced DRY THROAT (throat was dry) and APHONIA (As if she was losing her voice). On 13-Jan-2021, the patient experienced ILLNESS (sick and could not get out of bed/ sick for about 1.5 weeks), AXILLARY MASS (had a lump the size of a golf ball on her arm), PALPITATIONS (heart was also racing again (like when she had COVID19) and her pulse was very fast.), COVID-19 (As if I had COVID19 all over again), HEART RATE INCREASED (pulse was very fast), PAIN IN EXTREMITY (arm was also painful), PYREXIA (fever of 102.7 F) and HEADACHE (headache). At the time of the report, DRY THROAT (throat was dry), ILLNESS (sick and could not get out of bed/ sick for about 1.5 weeks), PALPITATIONS (heart was also racing again (like when she had COVID19) and her pulse was very fast.), COVID-19 (As if I had COVID19 all over again), HEART RATE INCREASED (pulse was very fast), APHONIA (As if she was losing her voice), PAIN IN EXTREMITY (arm was also painful), PYREXIA (fever of 102.7 F) and HEADACHE (headache) outcome was unknown and AXILLARY MASS (had a lump the size of a golf ball on her arm) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Jan-2021, Body temperature: 102.7 f High. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications reported. Treatment included Advil

Other Meds:

Current Illness: Asthma

ID: 1559008
Sex: F
Age: 68
State: IL

Vax Date: 02/25/2021
Onset Date: 02/25/2021
Rec V Date: 08/15/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025J20A
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

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

Symptoms: Almost passed out; Dizziness; Feel flushed; Joints feel inflamed; Soreness in her arm; Chills; soreness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PRESYNCOPE (Almost passed out), DIZZINESS (Dizziness), FLUSHING (Feel flushed), ARTHRITIS (Joints feel inflamed) and PAIN IN EXTREMITY (Soreness in her arm) in a 68-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. Concurrent medical conditions included Arthritis (arthritis in right arm). On 25-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced VACCINATION SITE PAIN (soreness at the injection site). On 26-Feb-2021, the patient experienced PRESYNCOPE (Almost passed out), DIZZINESS (Dizziness), FLUSHING (Feel flushed), ARTHRITIS (Joints feel inflamed), PAIN IN EXTREMITY (Soreness in her arm) and CHILLS (Chills). At the time of the report, PRESYNCOPE (Almost passed out), DIZZINESS (Dizziness), FLUSHING (Feel flushed), ARTHRITIS (Joints feel inflamed) and CHILLS (Chills) outcome was unknown and PAIN IN EXTREMITY (Soreness in her arm) and VACCINATION SITE PAIN (soreness at the injection site) had not resolved. No concomitant medications reported. Treatment included Tylenol

Other Meds:

Current Illness: Arthritis (arthritis in right arm)

ID: 1559009
Sex: M
Age:
State: GA

Vax Date: 01/29/2021
Onset Date:
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Nausea, Pain in extremity, Pyrexia

Symptoms: Sinus infection; This spontaneous case was reported by a consumer and describes the occurrence of in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 12M20A) for COVID-19 vaccination. No Medical History information was reported. On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant product information was not provided by the reporter. It was reported that the patient did not take any treatment medications for the events. Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: TCR Attached, event outcome updated.

Other Meds:

Current Illness:

ID: 1559010
Sex: F
Age:
State: FL

Vax Date: 02/09/2021
Onset Date: 02/09/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: headache on the left side; Nausea; she didn't feel good; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 03-Feb-2021 and was forwarded to Moderna on 10-Feb-2021. This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (she didn't feel good), HEADACHE (headache on the left side) and NAUSEA (Nausea) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. The patient's past medical history included Adverse reaction. Concomitant products included FAMOTIDINE for an unknown indication. On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced FEELING ABNORMAL (she didn't feel good). On 10-Feb-2021, the patient experienced HEADACHE (headache on the left side) and NAUSEA (Nausea). The patient was treated with IBUPROFEN (ADVEL) ongoing since an unknown date at an unspecified dose and frequency; PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency and OXYMETAZOLINE HYDROCHLORIDE (CLARITIN ALLERGIC) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (she didn't feel good), HEADACHE (headache on the left side) and NAUSEA (Nausea) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: US-MODERNATX, INC.-MOD-2021-164014:second dose

Other Meds: FAMOTIDINE

Current Illness:

ID: 1559011
Sex: F
Age:
State: PA

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: RA

Lab Data:

Allergies:

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

Symptoms: headache; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of HEADACHE (headache) and CHILLS (chills) in a 51-year-old 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, 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 HEADACHE (headache) and CHILLS (chills). The patient was treated with IBUPROFEN (ADVIL 12 HOUR) for Adverse event, at a dose of UNK dosage form. At the time of the report, HEADACHE (headache) and CHILLS (chills) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.

Other Meds:

Current Illness:

ID: 1559012
Sex: F
Age: 83
State: WA

Vax Date: 02/25/2021
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: RA

Lab Data:

Allergies:

Symptom List: Nausea

Symptoms: Headache; Fever; Injection site pain; Injection site swelling; Injection site redness; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), PYREXIA (Fever), VACCINATION SITE PAIN (Injection site pain), VACCINATION SITE SWELLING (Injection site swelling) and VACCINATION SITE ERYTHEMA (Injection site redness) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination. No Medical History information was reported. On 25-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headache), PYREXIA (Fever), VACCINATION SITE PAIN (Injection site pain), VACCINATION SITE SWELLING (Injection site swelling) and VACCINATION SITE ERYTHEMA (Injection site redness). At the time of the report, HEADACHE (Headache), PYREXIA (Fever), VACCINATION SITE PAIN (Injection site pain), VACCINATION SITE SWELLING (Injection site swelling) and VACCINATION SITE ERYTHEMA (Injection site redness) outcome was unknown.

Other Meds:

Current Illness:

ID: 1559013
Sex: F
Age: 34
State: NY

Vax Date: 02/26/2021
Onset Date: 02/26/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site pain

Symptoms: Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant) in a 35-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination. Concurrent medical conditions included Alcohol use (3 drinks/week). Concomitant products included DIPHENHYDRAMINE HYDROCHLORIDE (UNISOM [DIPHENHYDRAMINE HYDROCHLORIDE]) for Morning sickness, VITAMIN B6 for Nausea, MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication. On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 16-Nov-2020 and the estimated date of delivery was 28-Aug-2021. On 26-Feb-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the fourteenth week of the pregnancy. At the time of the report, EXPOSURE DURING PREGNANCY (Pregnant) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Dec-2020, Pregnancy test: Positive. On 07-Jan-2021, Ultrasound foetal: normal. On 28-Jan-2021, Amniocentesis: normal normal. On 28-Jan-2021, Ultrasound foetal: normal. On 18-Feb-2021, Amniocentesis: no results yet. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Treatment information was not provided.

Other Meds: PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]; UNISOM [DIPHENHYDRAMINE HYDROCHLORIDE]; VITAMIN B6

Current Illness:

ID: 1559014
Sex: F
Age:
State:

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

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

Lab Data:

Allergies:

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

Symptoms: Having reactions lasting for two weeks; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Having reactions lasting for two weeks) 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 VACCINATION SITE REACTION (Having reactions lasting for two weeks). At the time of the report, VACCINATION SITE REACTION (Having reactions lasting for two weeks) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.

Other Meds:

Current Illness:

ID: 1559015
Sex: M
Age: 84
State: AZ

Vax Date: 02/05/2021
Onset Date: 02/17/1900
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: dizziness; Difficult breathing; fast heart beat; light headedness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (light headedness), DIZZINESS (dizziness), DYSPNOEA (Difficult breathing) and HEART RATE INCREASED (fast heart beat) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20-2A) for COVID-19 vaccination. No Medical History information was reported. On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-1900, the patient experienced DIZZINESS (light headedness). On 17-Feb-2021, the patient experienced DIZZINESS (dizziness), DYSPNOEA (Difficult breathing) and HEART RATE INCREASED (fast heart beat). The patient was treated with ANTIBIOTICS for Adverse event, at a dose of UNK dosage form. At the time of the report, DIZZINESS (light headedness), DIZZINESS (dizziness), DYSPNOEA (Difficult breathing) and HEART RATE INCREASED (fast heart beat) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: negative (Negative) negative for pneumonia. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.

Other Meds:

Current Illness:

ID: 1559016
Sex: M
Age: 43
State: NY

Vax Date: 02/23/2021
Onset Date:
Rec V Date: 08/15/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 039K20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Tremor

Symptoms: lymphocyte count was 22 and now it is 14.7; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHOPENIA (lymphocyte count was 22 and now it is 14.7) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination. No Medical History information was reported. On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LYMPHOPENIA (lymphocyte count was 22 and now it is 14.7). At the time of the report, LYMPHOPENIA (lymphocyte count was 22 and now it is 14.7) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.

Other Meds:

Current Illness:

ID: 1559017
Sex: M
Age: 82
State: FL

Vax Date: 01/11/2021
Onset Date: 02/09/2021
Rec V Date: 08/15/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Erythema, Pruritus

Symptoms: Injection site swelling; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE SWELLING (Injection site swelling) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 010M20A) for COVID-19 vaccination. The patient's past medical history included No adverse event. On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Feb-2021, the patient experienced INJECTION SITE SWELLING (Injection site swelling). At the time of the report, INJECTION SITE SWELLING (Injection site swelling) outcome was unknown. Not Provided No concomitant medications reported. No treatment information provided.

Other Meds:

Current Illness:

ID: 1559018
Sex: U
Age: 67
State: MN

Vax Date: 02/26/2021
Onset Date:
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: ear ache; scratchy throat on the right side; Neck Pain; pain; This spontaneous case was reported by a consumer and describes the occurrence of EAR PAIN (ear ache), OROPHARYNGEAL PAIN (scratchy throat on the right side), NECK PAIN (Neck Pain) and EYE PAIN (pain) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination. No Medical History information was reported. On 26-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EAR PAIN (ear ache), OROPHARYNGEAL PAIN (scratchy throat on the right side), NECK PAIN (Neck Pain) and EYE PAIN (pain). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of UNK dosage form. At the time of the report, EAR PAIN (ear ache), OROPHARYNGEAL PAIN (scratchy throat on the right side), NECK PAIN (Neck Pain) and EYE PAIN (pain) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.

Other Meds:

Current Illness:

ID: 1559019
Sex: F
Age: 42
State: TX

Vax Date: 02/05/2021
Onset Date: 02/08/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Cough, Limb discomfort, Pain, SARS-CoV-2 test positive

Symptoms: feel pain; swelling in her armpit left area; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (feel pain) and PERIPHERAL SWELLING (swelling in her armpit left area) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. can't find it) for COVID-19 vaccination. The patient's past medical history included No adverse event. On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, the patient experienced PAIN IN EXTREMITY (feel pain) and PERIPHERAL SWELLING (swelling in her armpit left area). Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications reported. No treatment information provided. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1559020
Sex: F
Age: 81
State: MD

Vax Date: 02/12/2021
Onset Date:
Rec V Date: 08/15/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 039K20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Asthenia, Chills, Headache, Myalgia

Symptoms: soreness; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (soreness) and FATIGUE (fatigue) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN (soreness) and FATIGUE (fatigue). At the time of the report, PAIN (soreness) and FATIGUE (fatigue) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment information was provided.

Other Meds:

Current Illness:

ID: 1559021
Sex: M
Age:
State: NY

Vax Date: 02/11/2021
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: SYR
Vax Site: LA

Lab Data:

Allergies:

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

Symptoms: Sore throat; Fever; A spontaneous report was received from a type concerning a 79-years-old patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events sore throat and fever. The patient's medical history was not provided. Concomitant medications reported were atorvastatin, Flomax, Metoprolol, hemocoel, ezetimibe, aspirin drugs used for unknown indication. On 11 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 020M204) via unknown route for prophylaxis of COVID-19 infection. On an unknown date, the patient experienced the event(s) sore throat, fever. Treatment details included azithromycin since yesterday. Action taken with mRNA-1273 in response to the events was not reported. The outcome of events, sore throat and fever were unknown.

Other Meds: ATORVASTATIN; FLOMAX; METOPROLOL; EZETIMIBE; ASPIRIN (E.C.)

Current Illness:

ID: 1559022
Sex: F
Age: 44
State: HI

Vax Date: 02/11/2021
Onset Date: 02/12/2021
Rec V Date: 08/15/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot: EK9231
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Chills, Feeling cold, Feeling hot, Myalgia, Pain

Symptoms: This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (extremely sick), CHILLS (chills), PAIN (body aches), HEADACHE (Headache) and MYALGIA (muscle aches) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Psoriasis. On 11-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced ILLNESS (extremely sick), CHILLS (chills), PAIN (body aches), HEADACHE (Headache) and MYALGIA (muscle aches). On 13-Feb-2021, the patient experienced ARTHRALGIA (joint aches). The patient was treated with IBUPROFEN (ADVIL 12 HOUR) for Adverse event, at an unspecified dose and frequency. On 14-Feb-2021, ILLNESS (extremely sick) and CHILLS (chills) had resolved. At the time of the report, PAIN (body aches), HEADACHE (Headache), MYALGIA (muscle aches) and ARTHRALGIA (joint aches) outcome was unknown.

Other Meds:

Current Illness:

ID: 1559023
Sex: M
Age: 77
State:

Vax Date: 02/08/2021
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: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Pain in extremity

Symptoms: bloody nose; This spontaneous case was reported by a consumer and describes the occurrence of EPISTAXIS (bloody nose) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 30L20A) for COVID-19 vaccination. Concurrent medical conditions included Factor XI deficiency (but hadn't had a bloody nose in 2 months.). Concomitant products included SODIUM CHLORIDE (SALINE SPRAY) for an unknown indication. On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, the patient experienced EPISTAXIS (bloody nose). On 10-Feb-2021, EPISTAXIS (bloody nose) had resolved. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No treatment information provided. Most recent FOLLOW-UP information incorporated above includes: On 10-Feb-2021: Patient's medical history updated. On 28-Jun-2021: Possible NNI

Other Meds: SALINE SPRAY

Current Illness: Factor XI deficiency (but hadn't had a bloody nose in 2 months.)

ID: 1559024
Sex: M
Age:
State:

Vax Date: 02/25/2021
Onset Date: 02/26/2021
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: fever of 102; chills; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever of 102) and 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 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 PYREXIA (fever of 102) and CHILLS (chills). At the time of the report, PYREXIA (fever of 102) and CHILLS (chills) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment information was provided.

Other Meds:

Current Illness:

ID: 1559025
Sex: M
Age:
State:

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: Consciousness fluctuating, Crying, Dry skin, Epistaxis, Headache

Symptoms: Side effects after the 1st dose.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Side effects after the 1st dose.) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 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 VACCINATION COMPLICATION (Side effects after the 1st dose.). At the time of the report, VACCINATION COMPLICATION (Side effects after the 1st dose.) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment information provided.

Other Meds:

Current Illness:

ID: 1559026
Sex: F
Age: 34
State: PA

Vax Date: 01/28/2021
Onset Date: 01/28/2021
Rec V Date: 08/15/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Hypotonia, Lethargy, Respiratory rate decreased, Screaming, Skin warm

Symptoms: Pregnant; This spontaneous retrospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-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 an unknown date and the estimated date of delivery was 14-Feb-2021. On 28-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant). The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Delivered NOS. patient was still pregnant when she got the first vaccine and then gave birth before she got her second vaccine. On 26-Feb-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No Concomitant medications was provided by the reporter. No Treatment medications was provided by the reporter.

Other Meds:

Current Illness:

ID: 1559027
Sex: M
Age: 65
State:

Vax Date: 02/08/2021
Onset Date: 02/20/2021
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: COVID-19; Diarrhea; Lack of appetite; Body temperature increased; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19), DIARRHOEA (Diarrhea), DECREASED APPETITE (Lack of appetite) and PYREXIA (Body temperature increased) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination. Concurrent medical conditions included Hypertension, Hyperlipidemia and Acid reflux (esophageal). Concomitant products included MULTIVITAMIN [VITAMINS NOS] for an unknown indication. On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Feb-2021, the patient experienced COVID-19 (COVID-19), DIARRHOEA (Diarrhea), DECREASED APPETITE (Lack of appetite) and PYREXIA (Body temperature increased). At the time of the report, COVID-19 (COVID-19), DIARRHOEA (Diarrhea), DECREASED APPETITE (Lack of appetite) and PYREXIA (Body temperature increased) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Feb-2021, Body temperature: 101 (High) Body temperature was 101 degree Fahrenheit. On 20-Feb-2021, COVID-19: positive (Positive) Positive for COVID-19. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No treatment medication was reported. Concomitant products included High blood pressure medication, Hyperlipidemia medication and Acid reflux medication. Patient was scheduled for second dose of mRNA-1273 on 10-Mar-2021.

Other Meds: MULTIVITAMIN [VITAMINS NOS]

Current Illness: Acid reflux (esophageal); Hyperlipidemia; Hypertension

ID: 1559028
Sex: M
Age: 91
State: MD

Vax Date: 02/23/2021
Onset Date: 02/23/2021
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: Arm pain; fast heart rate; fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm pain), PALPITATIONS (fast heart rate) and PYREXIA (fever) in a 91-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination. Concurrent medical conditions included Hypertension. On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm pain), PALPITATIONS (fast heart rate) and PYREXIA (fever). At the time of the report, PAIN IN EXTREMITY (Arm pain), PALPITATIONS (fast heart rate) and PYREXIA (fever) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment information provided.

Other Meds:

Current Illness: Hypertension

ID: 1559029
Sex: M
Age: 82
State: OH

Vax Date: 01/25/2021
Onset Date: 02/25/2021
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: Sore Arm; Felt like in a daze; Memory lapse; Seems like he lost it; Got the chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore Arm), FEELING ABNORMAL (Felt like in a daze), MEMORY IMPAIRMENT (Memory lapse), SENSORY LOSS (Seems like he lost it) and CHILLS (Got the chills) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 038K20A) for COVID-19 vaccination. No Medical History information was reported. On 25-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 25-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore Arm), FEELING ABNORMAL (Felt like in a daze), MEMORY IMPAIRMENT (Memory lapse), SENSORY LOSS (Seems like he lost it) and CHILLS (Got the chills). At the time of the report, PAIN IN EXTREMITY (Sore Arm), FEELING ABNORMAL (Felt like in a daze), MEMORY IMPAIRMENT (Memory lapse), SENSORY LOSS (Seems like he lost it) and CHILLS (Got the chills) had resolved. No treatment information was provided.

Other Meds:

Current Illness:

ID: 1559030
Sex: F
Age: 48
State: NJ

Vax Date: 01/29/2021
Onset Date:
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: On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ORAL PAIN (Mouth sores or blisters in mouth day after 1st dose). The patient was treated with PARACETAMOL (TYLENOL) for Symptomatic treatment, at an unspecified dose and frequency. At the time of the report, ORAL PAIN (Mouth sores or blisters in mouth day after 1st dose) 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:

Current Illness:

ID: 1559031
Sex: F
Age:
State: OK

Vax Date: 02/23/2021
Onset Date: 02/23/2021
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: Feeling Tired; Having Chills; Nausea; Feeling achy; Muscle ache; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Feeling Tired), CHILLS (Having Chills), NAUSEA (Nausea), PAIN (Feeling achy) and MYALGIA (Muscle ache) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination. No Medical History information was reported. On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced FATIGUE (Feeling Tired), CHILLS (Having Chills), NAUSEA (Nausea), PAIN (Feeling achy) and MYALGIA (Muscle ache). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of 1 dosage form; NAPROXEN SODIUM (ALEVE) ongoing since an unknown date at a dose of 1 dosage form and DIMENHYDRINATE (DRAMAMINE) ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, FATIGUE (Feeling Tired), CHILLS (Having Chills), NAUSEA (Nausea), PAIN (Feeling achy) and MYALGIA (Muscle ache) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.

Other Meds:

Current Illness:

ID: 1559032
Sex: F
Age: 54
State: MD

Vax Date: 01/28/2021
Onset Date: 02/25/2021
Rec V Date: 08/15/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 037K20A
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Hot flush, Myalgia, Nausea, Tension headache

Symptoms: Soreness in face; Redness in her face; Itching in her face; This spontaneous case was reported by a consumer and describes the occurrence of FACIAL PAIN (Soreness in face), ERYTHEMA (Redness in her face) and PRURITUS (Itching in her face) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025520A and 013l20a) for COVID-19 vaccination. Concurrent medical conditions included Blood pressure high since 01-Jan-2005, Acid reflux (oesophageal) since 01-Jan-2000, Depression since 01-Jan-2011, Drug allergy (codeine) and Sulfonamide allergy (Sulfa drugs). Concomitant products included CHLORTHALIDONE from 01-Jan-2015 to an unknown date, POTASSIUM CHLORIDE from 01-Jan-2019 to an unknown date and ACETYLSALICYLIC ACID (ASPIRIN 81) from 01-Jan-2005 to an unknown date for Blood pressure, VALSARTAN from 01-Jan-2005 to an unknown date for Blood pressure high, ARMODAFINIL (NUVIGIL) from 01-Jan-2005 to an unknown date for Sleep apnea. On 28-Jan-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 FACIAL PAIN (Soreness in face), ERYTHEMA (Redness in her face) and PRURITUS (Itching in her face). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) for Adverse event, at a dose of 50 milligram; STEROIDS for Adverse event, at a dose of UNK dosage form; ASCORBIC ACID, ROSA CANINA FRUIT (VITAMIN C & ROSEHIP) for Adverse event, at a dose of 1000 milligram and CYANOCOBALAMIN, FOLIC ACID (VITAMIN B12 & FOLIC ACID) for Adverse event, at a dose of 2000 milligram. On 01-Mar-2021, ERYTHEMA (Redness in her face) and PRURITUS (Itching in her face) had resolved with sequelae. At the time of the report, FACIAL PAIN (Soreness in face) outcome was unknown. Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: Follow up received on 29 April 2021 added patient demographics, medical history, vaccine information, concomitant medication,event outcome, treatment information.

Other Meds: VALSARTAN; NUVIGIL; CHLORTHALIDONE; POTASSIUM CHLORIDE; ASPIRIN 81

Current Illness: Acid reflux (oesophageal); Blood pressure high; Depression; Drug allergy (codeine)

Total 2021 VAERS Injuries: 636,615

Page last modified: 03 October 2021 5:28pm