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**
PLEASE CHECK BACK SOON
Download the files above while you wait.






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: 1569722
Sex: F
Age: 65
State: LA

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: 037K20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Dysphagia, Epiglottitis

Symptoms: feels dizzy; feeling really bad; freezer; Very sick; nauseous; throwing; A spontaneous report was received from a 65-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced feels dizzy/ dizziness ,nauseous/ nausea, felt like she was going to pass out/loss of consciousness, throwing up/vomiting, feeling really bad/feeling abnormal, freezer and cold /nasopharyngitis and very sick/illness. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 18 Mar 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) via unknown route for prophylaxis of COVID-19 infection. On 19 Mar 2021, after receiving mRNA-1273, the patient felt dizzy ,nauseous and felt like she was going to pass out. She tried to talk on the phone but she was throwing up and feeling really bad. She was freezer and cold. Very sick. She's going to the ER right then. Action taken with mRNA-1273 in response to the events was unknown. The outcome of events, dizziness, nausea, loss of consciousness , vomiting ,feeling abnormal, nasopharyngitis and illness were not considered to be resolved at the time of the report.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events and a causal relationship cannot be excluded. Further information has been requested.

Other Meds:

Current Illness:

ID: 1569723
Sex: F
Age:
State: SC

Vax Date: 02/09/2021
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: Fever 100.1; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever 100.1) and HEADACHE (Headache) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030214) for COVID-19 vaccination. The patient's past medical history included COVID-19 in October 2020. On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Mar-2021, the patient experienced PYREXIA (Fever 100.1) and HEADACHE (Headache). At the time of the report, PYREXIA (Fever 100.1) and HEADACHE (Headache) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Mar-2021, Body temperature: 100.1 (High) fever 100.1. Concomitant product use was not provided by the reporter. Treatment information was not provided.

Other Meds:

Current Illness:

ID: 1569724
Sex: F
Age: 69
State: OR

Vax Date: 03/01/2021
Onset Date: 03/10/2021
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 VACCINATION SITE WARMTH (hot and throbbing spot at injection site), RASH PAPULAR (red spots get bigger and bigger, like 5 inches by 3 inches now) and VACCINATION SITE ERYTHEMA (red spot at injection site) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination. The patient's past medical history included No adverse event. On 01-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 VACCINATION SITE WARMTH (hot and throbbing spot at injection site) and VACCINATION SITE ERYTHEMA (red spot at injection site). On an unknown date, the patient experienced RASH PAPULAR (red spots get bigger and bigger, like 5 inches by 3 inches now). The patient was treated with DOXYCYCLINE at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (hot and throbbing spot at injection site), RASH PAPULAR (red spots get bigger and bigger, like 5 inches by 3 inches now) and VACCINATION SITE ERYTHEMA (red spot at injection site) outcome was unknown. 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.

Other Meds:

Current Illness:

ID: 1569725
Sex: F
Age: 91
State: FL

Vax Date: 03/16/2021
Onset Date: 03/16/2021
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: itching around the site of injection; Sore arm around the site of injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (itching around the site of injection) and VACCINATION SITE PAIN (Sore arm around the site of injection) in a 91-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination. No relevant medical history reported. Concomitant products included TRAMADOL, PREDNISONE and TORSEMIDE for an unknown indication. On 16-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (itching around the site of injection) and VACCINATION SITE PAIN (Sore arm around the site of injection). At the time of the report, VACCINATION SITE PRURITUS (itching around the site of injection) and VACCINATION SITE PAIN (Sore arm around the site of injection) outcome was unknown. No treatment drug reported. Patient asked if she should put and ice pack on it or use cortisone cream. Patient mentioned she has only one lot and she was not sure whether its from the first vaccine or the second vaccine

Other Meds: TRAMADOL; PREDNISONE; TORSEMIDE

Current Illness:

ID: 1569726
Sex: F
Age: 76
State: NJ

Vax Date: 02/27/2021
Onset Date: 03/19/2021
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: Given the second dose 19 days after the first dose; A spontaneous report was received from a pharmacist concerning a 76-years-old female patient who received first dose of Moderna's COVID-19 vaccine (mRNA-1273) and was given the second dose 19 days after the first dose. The patient's medical history was not provided. No relevant concomitant medications were reported. On 27 Feb 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (lot/batch number: unknown) intramuscularly for prophylaxis of COVID-19 infection. On 19 Mar 2021, the patient was given the second dose 19 days after the first dose. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not provided. The outcome of the event was given the second dose 19 days after the first dose was considered recovered on 19 Mar 2021.; Reporter's Comments: This report refers to a case of inappropriate schedule of vaccine administered for mRNA-1273 (lot #unknown) with no associated AEs reported

Other Meds:

Current Illness:

ID: 1569727
Sex: M
Age: 82
State: NY

Vax Date: 01/12/2021
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: Passed the 37 days mark for the second dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Passed the 37 days mark for the second dose) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. No Medical History information was reported. On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Passed the 37 days mark for the second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Passed the 37 days mark for the second dose) had resolved. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medication details was reported. No treatment medication details was reported.

Other Meds:

Current Illness:

ID: 1569728
Sex: F
Age: 57
State:

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: 011J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Pyrexia, White blood cell count decreased

Symptoms: Had some pain in the arm in that area of the injection, it was sore; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE PAIN (Had some pain in the arm in that area of the injection, it was sore) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination. Concurrent medical conditions included Epilepsy. 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 VACCINATION SITE PAIN (Had some pain in the arm in that area of the injection, it was sore). On 18-Mar-2021, VACCINATION SITE PAIN (Had some pain in the arm in that area of the injection, it was sore) 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. Patient was scheduled to get the second dose on 15Apr2021 but has a brain surgery for epilepsy scheduled for the 14Apr2021 from before, so they inquire if they should advance the second dose or delay it, because they won't be able to attend the appointment since they will be in the hospital. Concomitant medication and treatment drug not reported.

Other Meds:

Current Illness: Epilepsy

ID: 1569729
Sex: M
Age: 64
State: NY

Vax Date: 03/01/2021
Onset Date: 03/01/2021
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: severe diarrhea; diffuse abdominal pain; swollen lump in face; face redness; migratory arthralgia in right foot; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN (diffuse abdominal pain), SWELLING FACE (swollen lump in face), ERYTHEMA (face redness), ARTHRALGIA (migratory arthralgia in right foot) and DIARRHOEA (severe diarrhea) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 017B21A) for COVID-19 vaccination. Concurrent medical conditions included Ammoniacal dermatitis (Allergic to ammonia (hair dye).), Myasthenia gravis and Lymphoma. On 01-Mar-2021 at 1:15 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021 at 1:15 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On 01-Mar-2021, the patient experienced ABDOMINAL PAIN (diffuse abdominal pain), SWELLING FACE (swollen lump in face), ERYTHEMA (face redness) and ARTHRALGIA (migratory arthralgia in right foot). On an unknown date, the patient experienced DIARRHOEA (severe diarrhea). At the time of the report, ABDOMINAL PAIN (diffuse abdominal pain), SWELLING FACE (swollen lump in face), ERYTHEMA (face redness) and ARTHRALGIA (migratory arthralgia in right foot) outcome was unknown and DIARRHOEA (severe diarrhea) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and 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 reported. Most recent FOLLOW-UP information incorporated above includes: On 19-Apr-2021: No specific follow-up information recorded.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds:

Current Illness: Ammoniacal dermatitis (Allergic to ammonia (hair dye).); Lymphoma; Myasthenia gravis

ID: 1569730
Sex: F
Age: 69
State: LA

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: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Abdominal pain, Chills, Sleep disorder

Symptoms: pain and soreness on the injection side; pain on the other side near her pacemaker; legs sore; ankles are sore; Her legs, ankles, and toes are sore as well / Fingers are sore too; She feels a little warm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PAIN (pain and soreness on the injection side), CHEST PAIN (pain on the other side near her pacemaker), PAIN IN EXTREMITY (legs sore), ARTHRALGIA (ankles are sore) and PAIN IN EXTREMITY (Her legs, ankles, and toes are sore as well / Fingers are sore too) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Pacemaker insertion (cardiac). On 18-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (pain and soreness on the injection side), CHEST PAIN (pain on the other side near her pacemaker), PAIN IN EXTREMITY (legs sore), ARTHRALGIA (ankles are sore), PAIN IN EXTREMITY (Her legs, ankles, and toes are sore as well / Fingers are sore too) and FEELING HOT (She feels a little warm). At the time of the report, VACCINATION SITE PAIN (pain and soreness on the injection side), CHEST PAIN (pain on the other side near her pacemaker), PAIN IN EXTREMITY (legs sore), ARTHRALGIA (ankles are sore), PAIN IN EXTREMITY (Her legs, ankles, and toes are sore as well / Fingers are sore too) and FEELING HOT (She feels a little warm) outcome was unknown. Not Provided For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Action taken for the mRNA-1273 (Moderna COVID-19 Vaccine) not applicable.

Other Meds:

Current Illness:

ID: 1569731
Sex: F
Age: 67
State: FL

Vax Date: 03/02/2021
Onset Date:
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: swelling; arm pain; itch; developed a rash at injection site; fever; joint pain; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (swelling), PAIN IN EXTREMITY (arm pain), PRURITUS (itch), VACCINATION SITE RASH (developed a rash at injection site) and PYREXIA (fever) in a 66-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. No Medical History information was reported. On 02-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 SWELLING (swelling), PAIN IN EXTREMITY (arm pain), PRURITUS (itch), VACCINATION SITE RASH (developed a rash at injection site), PYREXIA (fever) and ARTHRALGIA (joint pain). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, SWELLING (swelling), PAIN IN EXTREMITY (arm pain), PRURITUS (itch), VACCINATION SITE RASH (developed a rash at injection site), PYREXIA (fever) and ARTHRALGIA (joint pain) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication were given by the reporter.

Other Meds:

Current Illness:

ID: 1569732
Sex: M
Age:
State: NY

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

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

Lab Data:

Allergies:

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

Symptoms: Cough after 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Cough after 1st dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included No adverse event. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COUGH (Cough after 1st dose). At the time of the report, COUGH (Cough after 1st dose) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No relevant concomitant medications provided. No relevant treatment information provided. Most recent FOLLOW-UP information incorporated above includes: On 08-May-2021: No newinformation

Other Meds:

Current Illness:

ID: 1569733
Sex: F
Age:
State: CA

Vax Date: 03/11/2021
Onset Date: 03/12/2021
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: bottom had rash and was itchy; Itchy; Fatigue; Ached all over; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (bottom had rash and was itchy), PRURITUS (Itchy), FATIGUE (Fatigue) and MYALGIA (Ached all over) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. No Medical History information was reported. On 11-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 12-Mar-2021, the patient experienced RASH PRURITIC (bottom had rash and was itchy), PRURITUS (Itchy), FATIGUE (Fatigue) and MYALGIA (Ached all over). At the time of the report, RASH PRURITIC (bottom had rash and was itchy), PRURITUS (Itchy), FATIGUE (Fatigue) and MYALGIA (Ached all over) outcome was unknown. Not Provided No concomitant medication was reported. No treatment medication was reported. Action taken with mRNA-1273 with respect to events was not applicable.

Other Meds:

Current Illness:

ID: 1569734
Sex: F
Age: 48
State: FL

Vax Date: 03/12/2021
Onset Date: 03/12/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: face itching; face swelling; face was red from my neck up; chills; joint aches; body aches; Fever; This spontaneous case was reported by a physician and describes the occurrence of PRURITUS (face itching), FACE OEDEMA (face swelling), ERYTHEMA (face was red from my neck up), CHILLS (chills) and ARTHRALGIA (joint aches) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 12-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, the patient experienced CHILLS (chills), ARTHRALGIA (joint aches), MYALGIA (body aches) and PYREXIA (Fever). On 19-Mar-2021, the patient experienced FACE OEDEMA (face swelling) and ERYTHEMA (face was red from my neck up). On 20-Mar-2021, the patient experienced PRURITUS (face itching). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Itching, at a dose of 1 dosage form and HYDROCORTISONE (topical) for Itching, at a dose of 1 dosage form. At the time of the report, PRURITUS (face itching), FACE OEDEMA (face swelling), ERYTHEMA (face was red from my neck up), CHILLS (chills), ARTHRALGIA (joint aches), MYALGIA (body aches) and PYREXIA (Fever) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Mar-2021, Body temperature: 100.8 (High) Abnormal. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. Action taken with mRNA-1273 in response to the events was not applicable.

Other Meds:

Current Illness:

ID: 1569735
Sex: F
Age:
State: RI

Vax Date:
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: SYR
Vax Site: LA

Lab Data:

Allergies:

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

Symptoms: discomfort in throat/Arm Paresthesia; Numbness in right side of the arm/Numbness in right side of the face; Facial Paresthesia/Arm Paresthesia; This spontaneous case was reported by a health care professional and describes the occurrence of HYPOAESTHESIA (Numbness in right side of the arm/Numbness in right side of the face), PARAESTHESIA (Facial Paresthesia/Arm Paresthesia) and OROPHARYNGEAL DISCOMFORT (discomfort in throat/Arm Paresthesia) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concomitant products included LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) for an unknown indication. 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 HYPOAESTHESIA (Numbness in right side of the arm/Numbness in right side of the face), PARAESTHESIA (Facial Paresthesia/Arm Paresthesia) and OROPHARYNGEAL DISCOMFORT (discomfort in throat/Arm Paresthesia). At the time of the report, HYPOAESTHESIA (Numbness in right side of the arm/Numbness in right side of the face), PARAESTHESIA (Facial Paresthesia/Arm Paresthesia) and OROPHARYNGEAL DISCOMFORT (discomfort in throat/Arm Paresthesia) had resolved. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No treatment products reported.

Other Meds: BENADRYL 24 D

Current Illness:

ID: 1569736
Sex: F
Age: 70
State: GA

Vax Date: 03/10/2021
Onset Date: 03/18/2021
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: Redness; Swelling; Knot; Heat generating; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Redness), PERIPHERAL SWELLING (Swelling), LIMB MASS (Knot), FEELING HOT (Heat generating) and FATIGUE (Tiredness) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No relevant medical history was provided by the reporter. Concomitant products included METFORMIN, LOSARTAN, SPIRONOLACTONE, SERTRALINE, CALCIUM CITRATE, SIMVASTATIN, HYDROCHLOROTHIAZIDE, OXYMETAZOLINE HYDROCHLORIDE (CLARITIN ALLERGIC) and DIPHENHYDRAMINE 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 18-Mar-2021, the patient experienced FATIGUE (Tiredness). On 19-Mar-2021, the patient experienced ERYTHEMA (Redness), PERIPHERAL SWELLING (Swelling), LIMB MASS (Knot) and FEELING HOT (Heat generating). At the time of the report, ERYTHEMA (Redness), PERIPHERAL SWELLING (Swelling), LIMB MASS (Knot), FEELING HOT (Heat generating) and FATIGUE (Tiredness) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. On 19-Mar-2021, the patient observed her left arm was swollen, red and had a knot in it. The skin is also generating heat. These side effects had not subsided and are still present at this time. No treatment medication was reported.

Other Meds: METFORMIN; LOSARTAN; SPIRONOLACTONE; SERTRALINE; CALCIUM CITRATE; SIMVASTATIN; HYDROCHLOROTHIAZIDE; CLARITIN ALLERGIC; DIPHENHYDRAMINE.

Current Illness:

ID: 1569737
Sex: F
Age: 89
State:

Vax Date: 03/16/2021
Onset Date: 03/18/2021
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: left calf hot; left calf painful; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (left calf hot) and PAIN IN EXTREMITY (left calf painful) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 16-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced FEELING HOT (left calf hot) and PAIN IN EXTREMITY (left calf painful). At the time of the report, FEELING HOT (left calf hot) and PAIN IN EXTREMITY (left calf painful) outcome was unknown. No concomitant and treatment products reported. Action taken with mRNA-1273 in response to the events was Not Applicable.

Other Meds:

Current Illness:

ID: 1569738
Sex: F
Age: 68
State: KY

Vax Date: 03/10/2021
Onset Date: 03/18/2021
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: redness in right arm; swelling in right arm; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (redness in right arm) and PERIPHERAL SWELLING (swelling in right arm) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048H21H) for COVID-19 vaccination. No relevant medical history was provided by the reporter. On 10-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 ERYTHEMA (redness in right arm) and PERIPHERAL SWELLING (swelling in right arm). At the time of the report, ERYTHEMA (redness in right arm) and PERIPHERAL SWELLING (swelling in right arm) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication was reported. No treatment medication was reported.

Other Meds:

Current Illness:

ID: 1569739
Sex: F
Age: 68
State: OH

Vax Date: 03/11/2021
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: pain in left knee; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (pain in left knee) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination. No Medical History information was reported. On 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 ARTHRALGIA (pain in left knee). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, ARTHRALGIA (pain in left knee) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.

Other Meds:

Current Illness:

ID: 1569740
Sex: M
Age:
State: OH

Vax Date: 03/18/2021
Onset Date: 03/18/2021
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; Sore arm; Chills; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), PAIN IN EXTREMITY (Sore arm), CHILLS (Chills) and PAIN (Body aches) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination. Concurrent medical conditions included Diabetic and Heart disorder. Concomitant products included GLIPIZIDE, Metoprolol SUCCER, FUROSEMIDE, ALLOPURINOL, SIMVASTATIN, LISINOPRIL, DIGOXIN and METFORMIN HCL for an unknown indication. On 18-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 (Headache), PAIN IN EXTREMITY (Sore arm), CHILLS (Chills) and PAIN (Body aches). The patient was treated with NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency. At the time of the report, HEADACHE (Headache), PAIN IN EXTREMITY (Sore arm) and CHILLS (Chills) outcome was unknown and PAIN (Body aches) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.

Other Meds: GLIPIZIDE; Metoprolol SUCCER; FUROSEMIDE; ALLOPURINOL; SIMVASTATIN; LISINOPRIL; DIGOXIN; METFORMIN HCL

Current Illness: Diabetic; Heart disorder

ID: 1569741
Sex: M
Age: 74
State: FL

Vax Date: 03/15/2021
Onset Date: 03/18/2021
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: body ache; fever; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (body ache) and PYREXIA (fever) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A and 015M20A) for COVID-19 vaccination. Concurrent medical conditions included Hypertension. Concomitant products included GABAPENTIN for an unknown indication. On 15-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 18-Mar-2021, the patient experienced MYALGIA (body ache) and PYREXIA (fever). The patient was treated with PARACETAMOL (TYLENOL EXTRA STRENGTH) for Ache and Fever, at an unspecified dose and frequency. At the time of the report, MYALGIA (body ache) and PYREXIA (fever) outcome was unknown. Not Provided Additional concomitant medication included unspecified hypertension medication. Action taken with mRNA-1273 with respect to events was not applicable.

Other Meds: GABAPENTIN

Current Illness: Hypertension

ID: 1569742
Sex: U
Age: 61
State: NJ

Vax Date: 03/01/2021
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: 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: Constipation; Felt awful; This spontaneous case was reported by a consumer and describes the occurrence of CONSTIPATION (Constipation) and FEELING ABNORMAL (Felt awful) in a 61-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. In March 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced CONSTIPATION (Constipation) and FEELING ABNORMAL (Felt awful). At the time of the report, CONSTIPATION (Constipation) and FEELING ABNORMAL (Felt awful) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant and treatment products reported. It was reported that the patient received the vaccine about 10 days before the date of reporting. Treatment information was not provided.

Other Meds:

Current Illness:

ID: 1569743
Sex: F
Age: 35
State: GA

Vax Date: 03/15/2021
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: LA

Lab Data:

Allergies:

Symptom List: Unevaluable event

Symptoms: runny nose; chills; body aches; fever that ranged from 100.5 degrees to 99 degrees; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (runny nose), CHILLS (chills), MYALGIA (body aches) and PYREXIA (fever that ranged from 100.5 degrees to 99 degrees) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004AZ1A) for COVID-19 vaccination. No relevant medical history was provided by the reporter. Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) 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 18-Mar-2021, the patient experienced RHINORRHOEA (runny nose), CHILLS (chills), MYALGIA (body aches) and PYREXIA (fever that ranged from 100.5 degrees to 99 degrees). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, RHINORRHOEA (runny nose), CHILLS (chills), MYALGIA (body aches) and PYREXIA (fever that ranged from 100.5 degrees to 99 degrees) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: (abnormal) ranged from 100.5 degrees to 99 degrees. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Patient stated fever had continued to decline as well as some of the other symptoms. Some side effects were still present but were improving.

Other Meds: ZYRTEC [CETIRIZINE HYDROCHLORIDE]

Current Illness:

ID: 1569744
Sex: F
Age: 49
State: FL

Vax Date: 03/18/2021
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: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

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

Symptoms: This spontaneous case was reported by a consumer and describes the occurrence of INCORRECT DOSE ADMINISTERED (Received approximately 0.62ml of vaccine) and DEVICE CONNECTION ISSUE (About half of the vaccine spilled out because of an error in the needle) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) 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 INCORRECT DOSE ADMINISTERED (Received approximately 0.62ml of vaccine) and DEVICE CONNECTION ISSUE (About half of the vaccine spilled out because of an error in the needle). On 18-Mar-2021, INCORRECT DOSE ADMINISTERED (Received approximately 0.62ml of vaccine) and DEVICE CONNECTION ISSUE (About half of the vaccine spilled out because of an error in the needle) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product use was not provided by the reporter.; Reporter's Comments: This report refers to a case of incorrect dose administered, and device connection issue for mRNA-1273, lot # 040A21A with no associated AEs.

Other Meds:

Current Illness:

ID: 1569745
Sex: F
Age: 67
State: AZ

Vax Date: 03/10/2021
Onset Date: 03/10/2021
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: covid arm; very very red, hot, itching and burning; red circle got really red and started burning and itching; big red bulls eye; swollen; hot area/hot; red; This spontaneous case was reported by a consumer and describes the occurrence of OCULAR HYPERAEMIA (big red bulls eye), VACCINATION SITE OEDEMA (swollen), VACCINATION SITE WARMTH (hot area/hot), VACCINATION SITE REACTION (covid arm) and VACCINATION SITE PRURITUS (very very red, hot, itching and burning) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. 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 10-Mar-2021, the patient experienced VACCINATION SITE OEDEMA (swollen), VACCINATION SITE WARMTH (hot area/hot) and VACCINATION SITE ERYTHEMA (red). On 18-Mar-2021, the patient experienced OCULAR HYPERAEMIA (big red bulls eye), VACCINATION SITE PRURITUS (very very red, hot, itching and burning) and VACCINATION SITE PAIN (red circle got really red and started burning and itching). On an unknown date, the patient experienced VACCINATION SITE REACTION (covid arm). On 12-Mar-2021, VACCINATION SITE OEDEMA (swollen), VACCINATION SITE WARMTH (hot area/hot) and VACCINATION SITE ERYTHEMA (red) had resolved. On 19-Mar-2021, OCULAR HYPERAEMIA (big red bulls eye) had resolved. At the time of the report, VACCINATION SITE REACTION (covid arm), VACCINATION SITE PRURITUS (very very red, hot, itching and burning) and VACCINATION SITE PAIN (red circle got really red and started burning and itching) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged. No concomitant medications were reported. Treatment information was unknown. This case was linked to MOD-2021-267388 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: Telephone contact report received on 28-JUL-2021. Added New events big red bulls eye and covid arm. Updated action taken from unknown to no change.

Other Meds:

Current Illness:

ID: 1569746
Sex: F
Age: 45
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: Injection site pain, Menorrhagia

Symptoms: Swelling; Headache; Sore Injection Site; Vomiting; Body Aches; Joint pain; Fever 100.9F; Nausea; This spontaneous case was reported by a nurse and describes the occurrence of SWELLING (Swelling), HEADACHE (Headache), VACCINATION SITE PAIN (Sore Injection Site), VOMITING (Vomiting) and MYALGIA (Body Aches) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No relevant medical history was provided by the reporter. On 10-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 10-Feb-2021, the patient experienced SWELLING (Swelling), HEADACHE (Headache), VACCINATION SITE PAIN (Sore Injection Site), VOMITING (Vomiting), MYALGIA (Body Aches), ARTHRALGIA (Joint pain), PYREXIA (Fever 100.9F) and NAUSEA (Nausea). On 13-Feb-2021, SWELLING (Swelling), HEADACHE (Headache), VACCINATION SITE PAIN (Sore Injection Site), VOMITING (Vomiting), PYREXIA (Fever 100.9F) and NAUSEA (Nausea) had resolved. On 16-Feb-2021, MYALGIA (Body Aches) and ARTHRALGIA (Joint pain) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Feb-2021, Body temperature: 100.9 (abnormal) abnormal. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication was reported. No treatment medication was reported. Action taken with mRNA-1273 with respect to events was not applicable.

Other Meds:

Current Illness:

ID: 1569747
Sex: F
Age: 41
State: IL

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

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

Lab Data:

Allergies:

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

Symptoms: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (covid arm), HYPOAESTHESIA (arm numbness), ADVERSE DRUG REACTION (feeling like it's nerve related), PAIN (sharp pain) and PARAESTHESIA ORAL (tongue was tingling) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Pulmonary embolism. Concurrent medical conditions included Diabetes, Hypertension, Hypercholesterolemia and Allergy (Allergy, Unspecified). On 01-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 VACCINATION SITE REACTION (covid arm), HYPOAESTHESIA (arm numbness), ADVERSE DRUG REACTION (feeling like it's nerve related), PAIN (sharp pain), PARAESTHESIA ORAL (tongue was tingling), PARAESTHESIA (tingling on her cheek on the left side), VACCINATION SITE PRURITUS (extreme itching on the injection site) and FATIGUE (slight fatigue). At the time of the report, VACCINATION SITE REACTION (covid arm), ADVERSE DRUG REACTION (feeling like it's nerve related), PARAESTHESIA (tingling on her cheek on the left side) and VACCINATION SITE PRURITUS (extreme itching on the injection site) outcome was unknown and HYPOAESTHESIA (arm numbness), PAIN (sharp pain), PARAESTHESIA ORAL (tongue was tingling) and FATIGUE (slight fatigue) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No relevant concomitant medications were reported. Treatment information was not provided.

Other Meds:

Current Illness: Allergy (Allergy, Unspecified); Diabetes; Hypercholesterolemia; Hypertension

ID: 1569748
Sex: F
Age:
State: NY

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

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

Lab Data:

Allergies:

Symptom List: Nausea, Pain in extremity, Pyrexia

Symptoms: Neck pain; Back pain; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of NECK PAIN (Neck pain) and BACK PAIN (Back pain) 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 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 NECK PAIN (Neck pain) and BACK PAIN (Back pain). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Back pain and Neck pain, at an unspecified dose and frequency. At the time of the report, NECK PAIN (Neck pain) and BACK PAIN (Back pain) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Patient went to her doctor on 17-Mar-2021 and she was prescribed pain medication but the pharmacy did not had the medication available. She had taken Advil (ibuprofen) but the pain was still present at the time of reporting. She said she cannot sleep on her side but had to sleep on her back. She was not on any medication.

Other Meds:

Current Illness:

ID: 1569749
Sex: M
Age: 50
State: FL

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: RA

Lab Data:

Allergies:

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: swollen lymph node in neck area; arm sensitivity; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm sensitivity) and LYMPHADENOPATHY (swollen lymph node in neck area) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032MZ0A) for COVID-19 vaccination. No Medical History information was reported. On 17-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm sensitivity). On 19-Mar-2021, the patient experienced LYMPHADENOPATHY (swollen lymph node in neck area). At the time of the report, PAIN IN EXTREMITY (arm sensitivity) and LYMPHADENOPATHY (swollen lymph node in neck area) outcome was unknown. Not Provided No concomitant and treatment products reported. Action taken with mRNA-1273 in response to the events was Not Applicable.

Other Meds:

Current Illness:

ID: 1569750
Sex: F
Age: 67
State: WI

Vax Date: 03/18/2021
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: 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: Swollen under her armpit, near breast; lymph nodes are swollen; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Swollen under her armpit, near breast) and LYMPHADENOPATHY (lymph nodes are swollen) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045A21A and 031M20A) for COVID-19 vaccination. No medical history was reported by the reporter. Concomitant products included CALCIUM, VITAMIN C [ASCORBIC ACID] and VITAMIN D NOS for an unknown indication. 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) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced SWELLING (Swollen under her armpit, near breast) and LYMPHADENOPATHY (lymph nodes are swollen). At the time of the report, SWELLING (Swollen under her armpit, near breast) and LYMPHADENOPATHY (lymph nodes are swollen) outcome was unknown. Other relevant concomitant medicines included multi vitamin. The action taken with mRNA-1273 in response to the event was not applicable. No treatment information was provided.

Other Meds: CALCIUM; VITAMIN C [ASCORBIC ACID]; VITAMIN D NOS

Current Illness:

ID: 1569751
Sex: F
Age:
State: WI

Vax Date: 02/21/2021
Onset Date: 03/19/2021
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: "hurt to raise the arm"; "soreish arm"; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA ("soreish arm") and PAIN IN EXTREMITY ("hurt to raise the arm") in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 21-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) (unknown route) dosage was changed to 1 dosage form. On 19-Mar-2021, the patient experienced MYALGIA ("soreish arm") and PAIN IN EXTREMITY ("hurt to raise the arm"). At the time of the report, MYALGIA ("soreish arm") and PAIN IN EXTREMITY ("hurt to raise the arm") outcome was unknown. Not Provided No concomitant and treatment products reported. Action taken with mRNA-1273 in response to the events was Not Applicable.

Other Meds:

Current Illness:

ID: 1569752
Sex: F
Age:
State: IL

Vax Date: 02/19/2021
Onset Date: 02/19/2021
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: Sore arm; Tenderness; Circular rash; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), TENDERNESS (Tenderness) and RASH (Circular rash) in a female patient of an unknown age 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 19-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), TENDERNESS (Tenderness) and RASH (Circular rash). At the time of the report, PAIN IN EXTREMITY (Sore arm), TENDERNESS (Tenderness) and RASH (Circular rash) 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 was reported. No treatment medication was reported. This case was linked to MOD21-058317 (Linked Report).; Sender's Comments: MOD21-058317:

Other Meds:

Current Illness:

ID: 1569753
Sex: F
Age: 76
State: MI

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

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

Lab Data:

Allergies:

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

Symptoms: This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (shoulder and neck pain pretty bad) and NECK PAIN (shoulder and neck pain pretty bad, sometimes the pain is as severe as an electric shock) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination. No Medical History information was reported. On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, the patient experienced ARTHRALGIA (shoulder and neck pain pretty bad) and NECK PAIN (shoulder and neck pain pretty bad, sometimes the pain is as severe as an electric shock). At the time of the report, ARTHRALGIA (shoulder and neck pain pretty bad) and NECK PAIN (shoulder and neck pain pretty bad, sometimes the pain is as severe as an electric shock) outcome was unknown. No concomitant and treatment products reported. Action taken with mRNA-1273 in response to the events was Not Applicable. It was reporter she did not experience any side effects at all after the second shot. She went on to state she could tell if the shoulder and neck pain she experienced with the first shot was from the vaccine. Most recent FOLLOW-UP information incorporated above includes: On 08-May-2021: Followup information was received on 08 May 2021, dosage related information was updated.

Other Meds:

Current Illness:

ID: 1569754
Sex: F
Age:
State: WI

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: 011j20a
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

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

Symptoms: Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant) in a female patient of an unknown age (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination. No medical history information is reported. Concomitant products included LEVOTHYROXINE and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication. On 18-Mar-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 30-Sep-2020 and the estimated date of delivery was 05-Jul-2021. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the twenty-fourth 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 23-Oct-2020, Pregnancy test: positive (Positive) positive. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. concomitant medications included prenatal vitamins No treatment medications were provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.

Other Meds: LEVOTHYROXINE; BABY ASPIRIN

Current Illness:

ID: 1569755
Sex: M
Age:
State: NY

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

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

Lab Data:

Allergies:

Symptom List: Tremor

Symptoms: supper achy, like getting the flu; Diarrhea; constipation; lost his appetite; bad headache across the back of his head; chills ? he was hot and cold all day; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (supper achy, like getting the flu), DIARRHOEA (Diarrhea), CONSTIPATION (constipation), DECREASED APPETITE (lost his appetite) and HEADACHE (bad headache across the back of his head) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001421A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. 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 INFLUENZA LIKE ILLNESS (supper achy, like getting the flu), DIARRHOEA (Diarrhea), CONSTIPATION (constipation), DECREASED APPETITE (lost his appetite), HEADACHE (bad headache across the back of his head) and CHILLS (chills ? he was hot and cold all day). At the time of the report, INFLUENZA LIKE ILLNESS (supper achy, like getting the flu), DIARRHOEA (Diarrhea), CONSTIPATION (constipation), DECREASED APPETITE (lost his appetite), HEADACHE (bad headache across the back of his head) and CHILLS (chills ? he was hot and cold all day) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant and treatment medications were provided. One week after vaccination, the patient had bad headache across the back of head, super achy like getting the flu and lost appetite. Next day morning, the patient also had chills- hot and cold all day. On day 3 headache continued and by day 4 patient was better. On an unknown date, the patient experienced constipation and diarrhea. This case was linked to MOD-2021-115907 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 08-May-2021: Follow-up received on 08-05-2021:Significant information received, Added constipation and diarrhea as events.

Other Meds:

Current Illness:

ID: 1569756
Sex: F
Age:
State: MD

Vax Date: 03/10/2021
Onset Date: 03/10/2021
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: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (For next 2 days, patient's arm was red and sore around injection site after receiving 1st dose), VACCINATION SITE PAIN (For next 2 days, patient's arm was red and sore around injection site after receiving 1st dose), VACCINATION SITE PRURITUS (8 days later, she noticed that the arm was itching, warm and swollen at injection site on right arm), VACCINATION SITE WARMTH (8 days later, she noticed that the arm was itching, warm and swollen at injection site on right arm) and VACCINATION SITE SWELLING (8 days later, she noticed that the arm was itching, warm and swollen at injection site on right arm) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) 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) .5 ml. On 10-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (For next 2 days, patient's arm was red and sore around injection site after receiving 1st dose) and VACCINATION SITE PAIN (For next 2 days, patient's arm was red and sore around injection site after receiving 1st dose). On 18-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (8 days later, she noticed that the arm was itching, warm and swollen at injection site on right arm), VACCINATION SITE WARMTH (8 days later, she noticed that the arm was itching, warm and swollen at injection site on right arm) and VACCINATION SITE SWELLING (8 days later, she noticed that the arm was itching, warm and swollen at injection site on right arm). On 13-Mar-2021, VACCINATION SITE ERYTHEMA (For next 2 days, patient's arm was red and sore around injection site after receiving 1st dose) and VACCINATION SITE PAIN (For next 2 days, patient's arm was red and sore around injection site after receiving 1st dose) had resolved. At the time of the report, VACCINATION SITE PRURITUS (8 days later, she noticed that the arm was itching, warm and swollen at injection site on right arm), VACCINATION SITE WARMTH (8 days later, she noticed that the arm was itching, warm and swollen at injection site on right arm) and VACCINATION SITE SWELLING (8 days later, she noticed that the arm was itching, warm and swollen at injection site on right arm) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment products reported. Concomitant products included Cholesterol medication, Low dose Aspirin and Multi-vitamin.

Other Meds:

Current Illness:

ID: 1569757
Sex: M
Age: 35
State: FL

Vax Date: 03/20/2021
Onset Date: 03/20/2021
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: Too Much dizzy; Headache; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Too Much dizzy) and HEADACHE (Headache) in a 35-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 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021, the patient experienced DIZZINESS (Too Much dizzy) and HEADACHE (Headache). At the time of the report, DIZZINESS (Too Much dizzy) and HEADACHE (Headache) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication was reported. Treatment information was not provided. Most recent FOLLOW-UP information incorporated above includes: On 09-May-2021: TCR Form received on 09-MAY-2021 and it doesn't have any new information

Other Meds:

Current Illness:

ID: 1569758
Sex: F
Age: 72
State: CT

Vax Date: 02/15/2021
Onset Date: 03/17/2021
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: This spontaneous case was reported by a consumer and describes the occurrence of URINARY TRACT INFECTION (Having an UTI), MALAISE (Just did not feel well), HEADACHE (Slight headache), CHILLS (Developed chills so bad she was shivering) and PYREXIA (Developed a fever of 99.0) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A210A and 016M2UA or OA) for COVID-19 vaccination. Concurrent medical conditions included UTI. On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Mar-2021, the patient experienced MALAISE (Just did not feel well), HEADACHE (Slight headache) and CHILLS (Developed chills so bad she was shivering). On 18-Mar-2021, the patient experienced URINARY TRACT INFECTION (Having an UTI) and PYREXIA (Developed a fever of 99.0). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, URINARY TRACT INFECTION (Having an UTI), MALAISE (Just did not feel well) and HEADACHE (Slight headache) outcome was unknown and CHILLS (Developed chills so bad she was shivering) and PYREXIA (Developed a fever of 99.0) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Mar-2021, Body temperature: 99.0 (High) Through out, the day her fever ranges from 102.8-103. On 19-Mar-2021, Body temperature: 102 (High) Around 102. No concomitant medication details was reported. Treatment medications included acetaminophen, unspecified antibiotics, and AZO. Action taken with mRNA-1273 in response to the events was not applicable.

Other Meds:

Current Illness: UTI

ID: 1569759
Sex: F
Age: 87
State: NY

Vax Date: 02/16/2021
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: Palpitations; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Palpitations) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination. The patient's past medical history included COVID-19 (Just had a little fever took Tylenol but was not hospitalized.) in September 2020. Concomitant products included METOPROLOL, RIVAROXABAN (XARELTO), SIMVASTATIN, OMEPRAZOLE, VITAMIN D NOS, ZINC and PARACETAMOL (TYLENOL) for an unknown indication. On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PALPITATIONS (Palpitations). At the time of the report, PALPITATIONS (Palpitations) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment medication was reported. This case was linked to MOD-2021-051779 (Patient Link).

Other Meds: METOPROLOL; XARELTO; SIMVASTATIN; OMEPRAZOLE; VITAMIN D NOS; ZINC; TYLENOL

Current Illness:

ID: 1569760
Sex: F
Age: 65
State:

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: 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: Stiffness muscle; Pain in arm; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Stiffness muscle ) and PAIN IN EXTREMITY (Pain in arm ) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination. The patient's past medical history included Surgery (She had surgery in her left arm.). On 18-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 muscle ) and PAIN IN EXTREMITY (Pain in arm ). At the time of the report, MUSCULOSKELETAL STIFFNESS (Stiffness muscle ) and PAIN IN EXTREMITY (Pain in arm ) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No treatment medication were provided. No concomitant medication were provided. Most recent FOLLOW-UP information incorporated above includes: On 08-May-2021: TCR on 08-May-2021 included no new information. Consumer doesn't want to provide email ID over phone and She doesn't have access to fax.

Other Meds:

Current Illness:

ID: 1569761
Sex: F
Age:
State: TX

Vax Date: 02/03/2021
Onset Date: 03/19/2021
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: She lost part of her vision/Her vision is distorted; She is having issues with one of her eyes; This spontaneous case was reported by a consumer and describes the occurrence of EYE DISORDER (She is having issues with one of her eyes) and VISUAL IMPAIRMENT (She lost part of her vision/Her vision is distorted) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046A21A and 012M20A) for COVID-19 vaccination. Concurrent medical conditions included Food allergy, Drug allergy and Allergy (Other products.). Concomitant products included HYOSCYAMINE from 20-Feb-2021 to an unknown date for Ache stomach, AMLODIPINE BESYLATE from 10-Jan-2021 to an unknown date and BISOPROLOL FUMARATE (BISOPROLOL FUMERATE) from 10-Jan-2021 to an unknown date for Blood pressure management, FUROSEMIDE from 25-Mar-2021 to an unknown date for Diuretic effect, DESIPRAMINE from 18-Feb-2021 to an unknown date for Stomach ache. On 03-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) (unknown route) dosage was changed to 1 dosage form. On 19-Mar-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EYE DISORDER (She is having issues with one of her eyes). On 25-Jun-2021, the patient experienced VISUAL IMPAIRMENT (She lost part of her vision/Her vision is distorted). On 25-Jun-2021, VISUAL IMPAIRMENT (She lost part of her vision/Her vision is distorted) had resolved. At the time of the report, EYE DISORDER (She is having issues with one of her eyes) had resolved. Not Provided No treatment details were reported. Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Patient demographics, dose one details, concomitant medications were added and dose 2 details and event details and outcome was updated.

Other Meds: FUROSEMIDE; AMLODIPINE BESYLATE; BISOPROLOL FUMERATE; HYOSCYAMINE; DESIPRAMINE

Current Illness: Allergy (Other products.); Drug allergy; Food allergy

ID: 1569762
Sex: F
Age: 45
State: TX

Vax Date: 02/23/2021
Onset Date: 03/09/2021
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: Warm to touch; Itchiness at injection site; Hardness; Red/brown circles; Raised skin/ swelling; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Warm to touch), VACCINATION SITE PRURITUS (Itchiness at injection site), VACCINATION SITE INDURATION (Hardness), VACCINATION SITE ERYTHEMA (Red/brown circles) and VACCINATION SITE SWELLING (Raised skin/ swelling) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced VACCINATION SITE WARMTH (Warm to touch), VACCINATION SITE PRURITUS (Itchiness at injection site), VACCINATION SITE INDURATION (Hardness), VACCINATION SITE ERYTHEMA (Red/brown circles) and VACCINATION SITE SWELLING (Raised skin/ swelling). At the time of the report, VACCINATION SITE WARMTH (Warm to touch), VACCINATION SITE PRURITUS (Itchiness at injection site), VACCINATION SITE INDURATION (Hardness), VACCINATION SITE ERYTHEMA (Red/brown circles) and VACCINATION SITE SWELLING (Raised skin/ swelling) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No relevant concomitant medications were reported. Treatment details was not reported by the reporter.

Other Meds:

Current Illness:

ID: 1569763
Sex: F
Age: 68
State: VT

Vax Date: 03/18/2021
Onset Date: 03/19/2021
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: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Blood pressure. 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 PAIN IN EXTREMITY (Sore arm). The patient was treated with PARACETAMOL (TYLENOL) for Fever and Painful arm, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Mar-2021, Body temperature: 101 (High) 101 degree Fahrenheit. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. The patient was on unspecified blood pressure medication.

Other Meds:

Current Illness: Blood pressure

ID: 1569764
Sex: F
Age: 28
State:

Vax Date: 03/10/2021
Onset Date: 03/17/2021
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: Arm tight like a sunburn; Arm hot to the touch; Big red circle; Arm pain; Covid arm; Left arm a little splotchy; Left arm felt weird; Arm felt tight; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE DYSAESTHESIA (Left arm felt weird), VACCINATION SITE MOVEMENT IMPAIRMENT (Arm felt tight), RASH ERYTHEMATOUS (Arm tight like a sunburn), VACCINATION SITE WARMTH (Arm hot to the touch) and VACCINATION SITE BRUISING (Big red circle) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003a21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 10-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 VACCINATION SITE DYSAESTHESIA (Left arm felt weird) and VACCINATION SITE MOVEMENT IMPAIRMENT (Arm felt tight). On 18-Mar-2021, the patient experienced RASH ERYTHEMATOUS (Arm tight like a sunburn), VACCINATION SITE WARMTH (Arm hot to the touch), VACCINATION SITE BRUISING (Big red circle), PAIN IN EXTREMITY (Arm pain), VACCINATION SITE REACTION (Covid arm) and VACCINATION SITE RASH (Left arm a little splotchy). The patient was treated with MELOXICAM on 18-Mar-2021 at an unspecified dose and frequency. At the time of the report, VACCINATION SITE DYSAESTHESIA (Left arm felt weird), VACCINATION SITE MOVEMENT IMPAIRMENT (Arm felt tight), RASH ERYTHEMATOUS (Arm tight like a sunburn), VACCINATION SITE WARMTH (Arm hot to the touch), VACCINATION SITE BRUISING (Big red circle), PAIN IN EXTREMITY (Arm pain), VACCINATION SITE REACTION (Covid arm) and VACCINATION SITE RASH (Left arm a little splotchy) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant products reported.

Other Meds:

Current Illness:

ID: 1569765
Sex: F
Age:
State: WI

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

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

Lab Data:

Allergies:

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

Symptoms: Hard time walking; Hands and legs are shaking/ Shaking too bad; Discovered couldn't get up from recliner; Got bad chills; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (Hard time walking), TREMOR (Hands and legs are shaking/ Shaking too bad), MOVEMENT DISORDER (Discovered couldn't get up from recliner) and CHILLS (Got bad chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 092971A) for COVID-19 vaccination. Concurrent medical conditions included Dizziness. On 08-Mar-2021 at 10:30 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, the patient experienced CHILLS (Got bad chills). On 09-Mar-2021, the patient experienced GAIT DISTURBANCE (Hard time walking), TREMOR (Hands and legs are shaking/ Shaking too bad) and MOVEMENT DISORDER (Discovered couldn't get up from recliner). At the time of the report, GAIT DISTURBANCE (Hard time walking), TREMOR (Hands and legs are shaking/ Shaking too bad), MOVEMENT DISORDER (Discovered couldn't get up from recliner) and CHILLS (Got bad chills) outcome was unknown. Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.

Other Meds:

Current Illness: Dizziness

ID: 1569766
Sex: F
Age: 74
State: MI

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: 026LZOA
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Vomiting

Symptoms: This spontaneous case was reported by a consumer and describes the occurrence of INCORRECT ROUTE OF PRODUCT ADMINISTRATION (second dose was put almost at the top of my shoulder where i can feel bone and there is very little), PAIN IN EXTREMITY (arm is still hurting), VACCINATION SITE MOVEMENT IMPAIRMENT (I can?t raise my arm like I used to), LIMB DISCOMFORT (it even interfers with dressing myself) and VACCINATION SITE DISCOMFORT (had quite a bit of discomfort when it was injected) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007M20A and 010A2*A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (second dose was put almost at the top of my shoulder where i can feel bone and there is very little), PAIN IN EXTREMITY (arm is still hurting), VACCINATION SITE DISCOMFORT (had quite a bit of discomfort when it was injected), PYREXIA (had some fever (100.2 F)) and PYREXIA (fever went back up like 3 times). On an unknown date, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (I can?t raise my arm like I used to) and LIMB DISCOMFORT (it even interfers with dressing myself). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (second dose was put almost at the top of my shoulder where i can feel bone and there is very little), PAIN IN EXTREMITY (arm is still hurting), VACCINATION SITE MOVEMENT IMPAIRMENT (I can?t raise my arm like I used to), LIMB DISCOMFORT (it even interfers with dressing myself), VACCINATION SITE DISCOMFORT (had quite a bit of discomfort when it was injected), PYREXIA (had some fever (100.2 F)) and PYREXIA (fever went back up like 3 times) outcome was unknown. Concomitant product use was not provided by the reporter. Action taken with mRNA-1273 in response to the event was not applicable.

Other Meds:

Current Illness:

ID: 1569767
Sex: F
Age: 23
State: IL

Vax Date: 03/10/2021
Onset Date: 03/12/2021
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: Weird swelling blisters on the left side of he lip; Swelling blisters on left side of lip; This spontaneous case was reported by a consumer and describes the occurrence of BLISTER (Weird swelling blisters on the left side of he lip) and SWELLING (Swelling blisters on left side of lip) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) 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 12-Mar-2021, the patient experienced BLISTER (Weird swelling blisters on the left side of he lip) and SWELLING (Swelling blisters on left side of lip). At the time of the report, BLISTER (Weird swelling blisters on the left side of he lip) and SWELLING (Swelling blisters on left side of lip) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medication included birth control. No treatment information was provided.

Other Meds: ASPIRIN (E.C.)

Current Illness:

ID: 1569768
Sex: F
Age: 79
State: MA

Vax Date: 02/22/2021
Onset Date: 02/22/2021
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: The site of injection is dark purple; The site of injection is sore/ painful; Swelling (size of an orange); This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOLOURATION (The site of injection is dark purple), VACCINATION SITE PAIN (The site of injection is sore/ painful) and VACCINATION SITE SWELLING (Swelling (size of an orange)) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) 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 22-Feb-2021, the patient experienced VACCINATION SITE DISCOLOURATION (The site of injection is dark purple), VACCINATION SITE PAIN (The site of injection is sore/ painful) and VACCINATION SITE SWELLING (Swelling (size of an orange)). At the time of the report, VACCINATION SITE DISCOLOURATION (The site of injection is dark purple), VACCINATION SITE PAIN (The site of injection is sore/ painful) and VACCINATION SITE SWELLING (Swelling (size of an orange)) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No relevant concomitant medications were provided. No treatment information was provided. This case was linked to MOD-2021-114285 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: Additional information received included no new information.

Other Meds:

Current Illness:

ID: 1569769
Sex: F
Age: 87
State: IL

Vax Date: 02/02/2021
Onset Date: 03/11/2021
Rec V Date: 08/15/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025j20-2A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site swelling, Limb discomfort

Symptoms: upset stomach; red rash at injection site; red rash at injection site; Sore arm; past 36 days from first dose; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), ABDOMINAL DISCOMFORT (upset stomach), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (past 36 days from first dose), INJECTION SITE RASH (red rash at injection site) and INJECTION SITE ERYTHEMA (red rash at injection site) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A and 032L20A) for COVID-19 vaccination. No relevant medical history was provided by the reporter. Concomitant products included LEVOTHYROXINE and METOPROLOL for an unknown indication. On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (past 36 days from first dose). On 12-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), INJECTION SITE RASH (red rash at injection site) and INJECTION SITE ERYTHEMA (red rash at injection site). On 15-Mar-2021, the patient experienced ABDOMINAL DISCOMFORT (upset stomach). On 11-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (past 36 days from first dose) had resolved. At the time of the report, PAIN IN EXTREMITY (Sore arm), INJECTION SITE RASH (red rash at injection site) and INJECTION SITE ERYTHEMA (red rash at injection site) had resolved and ABDOMINAL DISCOMFORT (upset stomach) outcome was unknown. No treatment medication was reported. Action taken with mRNA-1273 with respect to events was not applicable.

Other Meds: LEVOTHYROXINE; METOPROLOL

Current Illness:

ID: 1569770
Sex: F
Age: 84
State:

Vax Date: 03/12/2021
Onset Date: 03/12/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Chills, Diarrhoea, Fatigue, Feeling abnormal, Headache

Symptoms: red; itching; pain at site; rash on arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (pain at site), VACCINATION SITE RASH (rash on arm), VACCINATION SITE PRURITUS (itching) and ERYTHEMA (red) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 00B21A) for COVID-19 vaccination. No Medical History information was reported. On 12-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 12-Mar-2021, the patient experienced VACCINATION SITE PAIN (pain at site), VACCINATION SITE RASH (rash on arm), VACCINATION SITE PRURITUS (itching) and ERYTHEMA (red). At the time of the report, VACCINATION SITE PAIN (pain at site), VACCINATION SITE RASH (rash on arm), VACCINATION SITE PRURITUS (itching) and ERYTHEMA (red) outcome was unknown. No concomitant products reported. Benadryl was used as a treatment product. Action taken with mRNA-1273 in response to the events was Not Applicable. This case was linked to MOD21-051781 (E2B Linked Report).; Sender's Comments: MOD21-051781:cross link

Other Meds:

Current Illness:

ID: 1569771
Sex: F
Age: 87
State: NY

Vax Date: 02/16/2021
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: RA

Lab Data:

Allergies:

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

Symptoms: Lump at injection site/ Like a hard ball like trying to get into my blood it's like getting into my veins,like it's going to my blood vessels slowly; Like a hard ball like; Lump hurts when touched; Red spot at injection site; Palpitations; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Palpitations), VACCINATION SITE MASS (Lump at injection site/ Like a hard ball like trying to get into my blood it's like getting into my veins,like it's going to my blood vessels slowly), VACCINATION SITE INDURATION (Like a hard ball like), VACCINATION SITE PAIN (Lump hurts when touched) and VACCINATION SITE ERYTHEMA (Red spot at injection site) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 14M20A and 004M20A) for COVID-19 vaccination. The patient's past medical history included COVID-19 (Patient took Tylenol, just have a little fever, but was not hospitalized.) in September 2020. Concomitant products included METOPROLOL, RIVAROXABAN (XARELTO), SIMVASTATIN, OMEPRAZOLE, VITAMIN D NOS, ZINC and PARACETAMOL (TYLENOL) for an unknown indication. On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 18-Mar-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PALPITATIONS (Palpitations). On an unknown date, the patient experienced VACCINATION SITE MASS (Lump at injection site/ Like a hard ball like trying to get into my blood it's like getting into my veins,like it's going to my blood vessels slowly), VACCINATION SITE INDURATION (Like a hard ball like), VACCINATION SITE PAIN (Lump hurts when touched) and VACCINATION SITE ERYTHEMA (Red spot at injection site). At the time of the report, PALPITATIONS (Palpitations), VACCINATION SITE MASS (Lump at injection site/ Like a hard ball like trying to get into my blood it's like getting into my veins,like it's going to my blood vessels slowly), VACCINATION SITE INDURATION (Like a hard ball like), VACCINATION SITE PAIN (Lump hurts when touched) and VACCINATION SITE ERYTHEMA (Red spot at injection site) had resolved. No treatment information was provided. Patient stated that she was scheduled for an operation, surgery for her Pacemaker the week after she took the second dose of vaccine as reported. This case was linked to MOD-2021-051766. Most recent FOLLOW-UP information incorporated above includes: On 19-Jul-2021: Follow-up received on 19-Jul-2021 contains significant information. The event outcome was updated from unknown to recovered/ resolved.

Other Meds: METOPROLOL; XARELTO; SIMVASTATIN; OMEPRAZOLE; VITAMIN D NOS; ZINC; TYLENOL

Current Illness:

Total 2021 VAERS Injuries: 636,615

Page last modified: 03 October 2021 5:28pm