VAERS 2021 Database www.vaers.hhs.gov

Main Page | All 2021 Deaths | Videos
VAERS Updated: 10/01/2021
** VAERS DATABASE Last updated: October 1, 2021**
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Manufacturers

Total Manufacturer

Incidents per State

State Total
81,113
AK1,714
AL5,764
AR3,714
AS44
AZ13,902
CA61,408
CO11,540
CT8,301
DC1,684
DE1,779
FL38,956
FM3
GA14,350
GU90
HI2,312
IA4,534
ID2,585
IL20,431
IN23,113
KS4,507
KY7,614
LA5,033
MA14,651
MD12,530
ME3,136
MH8
MI19,033
MN12,001
MO9,478
MP30
MS2,865
MT2,259
NC16,365
ND1,362
NE2,902
NH3,001
NJ18,431
NM3,872
NV4,358
NY34,605
OH19,115
OK6,207
OR8,429
PA23,803
PR2,249
QM2
RI1,989
SC6,509
SD1,179
TN9,334
TX36,348
UT4,255
VA14,708
VI50
VT1,730
WA14,596
WI10,934
WV2,320
WY856
XB5
XL1
XV2

ID: 1560346
Sex: F
Age: 76
State: FL

Vax Date: 02/26/2021
Onset Date: 02/27/2021
Rec V Date: 08/15/2021
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Symptoms: fatigue; arm cherry red; arm swollen down to elbow; arm hot; arm itching; nausea; teeth chattering chills; fever; body aches; head aches; This spontaneous case was reported by a nurse and describes the occurrence of INJECTION SITE REACTION (arm swollen down to elbow), VACCINATION SITE WARMTH (arm hot), PRURITUS (arm itching), NAUSEA (nausea) and CHILLS (teeth chattering chills) in a 76-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 26-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced INJECTION SITE REACTION (arm swollen down to elbow), VACCINATION SITE WARMTH (arm hot), PRURITUS (arm itching), NAUSEA (nausea), CHILLS (teeth chattering chills), PYREXIA (fever), MYALGIA (body aches), HEADACHE (head aches) and INJECTION SITE ERYTHEMA (arm cherry red). On 28-Feb-2021, the patient experienced FATIGUE (fatigue). The patient was treated with PARACETAMOL (TYLENOL) on 27-Feb-2021 for Fever, at a dose of 650 milligram and METHYLPREDNISOLONE ACETATE (MEDROL [METHYLPREDNISOLONE ACETATE]) for Adverse reaction, at a dose of 4 milligram twice a day. On 27-Feb-2021, NAUSEA (nausea) had resolved. At the time of the report, INJECTION SITE REACTION (arm swollen down to elbow), VACCINATION SITE WARMTH (arm hot), PRURITUS (arm itching), CHILLS (teeth chattering chills), PYREXIA (fever), MYALGIA (body aches), HEADACHE (head aches), FATIGUE (fatigue) and INJECTION SITE ERYTHEMA (arm cherry red) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Feb-2021, Body temperature: 102.5 deg f (High) fever. On 28-Feb-2021, Body temperature: 105.5 deg f (High) fever. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications reported.

Other Meds:

Current Illness:

ID: 1560347
Sex: F
Age: 65
State: NJ

Vax Date: 02/26/2021
Onset Date: 02/26/2021
Rec V Date: 08/15/2021
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Symptoms: Chest tightness; Bone pain; Ear pain; Pain in the face; Neck pain; Diarrhea; Fever; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (Chest tightness), BONE PAIN (Bone pain), EAR PAIN (Ear pain), FACIAL PAIN (Pain in the face) and NECK PAIN (Neck pain) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced CHEST DISCOMFORT (Chest tightness), BONE PAIN (Bone pain), EAR PAIN (Ear pain), FACIAL PAIN (Pain in the face), NECK PAIN (Neck pain), DIARRHOEA (Diarrhea) and PYREXIA (Fever). The patient was treated with PARACETAMOL (TYLENOL) in February 2021 for Adverse reaction, at an unspecified dose and frequency. On 01-Mar-2021, CHEST DISCOMFORT (Chest tightness), BONE PAIN (Bone pain), EAR PAIN (Ear pain), FACIAL PAIN (Pain in the face), NECK PAIN (Neck pain), DIARRHOEA (Diarrhea) and PYREXIA (Fever) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported. Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: Follow-up received and reporter contact information was updated.

Other Meds:

Current Illness:

ID: 1560348
Sex: M
Age:
State:

Vax Date:
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Rec V Date: 08/15/2021
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Symptoms: experiencing some side effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (experiencing some side effects) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (experiencing some side effects). At the time of the report, VACCINATION COMPLICATION (experiencing some side effects) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication was reported. No treatment information was provided.

Other Meds:

Current Illness:

ID: 1560349
Sex: F
Age: 79
State: OH

Vax Date: 02/07/2021
Onset Date: 02/07/2021
Rec V Date: 08/15/2021
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Symptoms: Burning sensation from the injection site down to her elbow; Not feeling well in general; Soreness; Fatigue; Headache; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (Burning sensation from the injection site down to her elbow), MALAISE (Not feeling well in general), PAIN (Soreness), FATIGUE (Fatigue) and HEADACHE (Headache) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination. Concurrent medical conditions included Arthritis, Hypertension and Cholesterol. On 07-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Feb-2021, the patient experienced BURNING SENSATION (Burning sensation from the injection site down to her elbow), MALAISE (Not feeling well in general), PAIN (Soreness), FATIGUE (Fatigue) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Arthritis, at a dose of UNK dosage form and DIURETICS for Hypertension, at an unspecified dose and frequency. On 10-Feb-2021, MALAISE (Not feeling well in general), FATIGUE (Fatigue) and HEADACHE (Headache) had resolved. At the time of the report, BURNING SENSATION (Burning sensation from the injection site down to her elbow) and PAIN (Soreness) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. This case was linked to MOD-2021-099179 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: Patient Email address was not provided.

Other Meds:

Current Illness: Arthritis; Cholesterol; Hypertension

ID: 1560350
Sex: F
Age: 53
State: MA

Vax Date: 03/01/2021
Onset Date: 03/01/2021
Rec V Date: 08/15/2021
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Symptoms: persistent tingling in her right foot, toes, and ankle; lips were feeling dry and tingling; lips were feeling dry and tingling; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (persistent tingling in her right foot, toes, and ankle), LIP DRY (lips were feeling dry and tingling) and PARAESTHESIA ORAL (lips were feeling dry and tingling) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination. Concurrent medical conditions included Penicillin allergy (rash and hives), Drug allergy (welbutrin: rash and hives) and Menopause (experiencing hot flashes and chills). Concomitant products included MULTIVITAMINS [VITAMINS NOS] for an unknown indication. On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced PARAESTHESIA (persistent tingling in her right foot, toes, and ankle), LIP DRY (lips were feeling dry and tingling) and PARAESTHESIA ORAL (lips were feeling dry and tingling). At the time of the report, PARAESTHESIA (persistent tingling in her right foot, toes, and ankle), LIP DRY (lips were feeling dry and tingling) and PARAESTHESIA ORAL (lips were feeling dry and tingling) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Patient applied Vaseline for the event lips were feeling dry and tingling, and felt better at the time of report.

Other Meds: MULTIVITAMINS [VITAMINS NOS]

Current Illness: Menopause (experiencing hot flashes and chills); Penicillin allergy (rash and hives)

ID: 1560351
Sex: F
Age: 72
State: WA

Vax Date: 02/04/2021
Onset Date: 02/14/2021
Rec V Date: 08/15/2021
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Symptoms: low grade fever; diagnosed with shingles; skin pain; pain at the injection site; red rash around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (diagnosed with shingles), PAIN OF SKIN (skin pain), VACCINATION SITE PAIN (pain at the injection site), VACCINATION SITE RASH (red rash around the injection site) and PYREXIA (low grade fever) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. No medical history was provided by the reporter. Concomitant products included GABAPENTIN, LEVOTHYROXINE, PANTOPRAZOLE, LAMOTRIGINE, ACETYLSALICYLIC ACID (ASPIRIN CUPAL [ACETYLSALICYLIC ACID]) and PAROXETINE for an unknown indication. On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, the patient experienced VACCINATION SITE PAIN (pain at the injection site) and VACCINATION SITE RASH (red rash around the injection site). On 15-Feb-2021, the patient experienced PAIN OF SKIN (skin pain). On 18-Feb-2021, the patient experienced HERPES ZOSTER (diagnosed with shingles). On 23-Feb-2021, the patient experienced PYREXIA (low grade fever). The patient was treated with ACETAMINOPHEN in February 2021 for Adverse reaction, at an unspecified dose and frequency. On 25-Feb-2021, PYREXIA (low grade fever) had resolved. At the time of the report, HERPES ZOSTER (diagnosed with shingles), PAIN OF SKIN (skin pain), VACCINATION SITE PAIN (pain at the injection site) and VACCINATION SITE RASH (red rash around the injection site) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. It was also reported that the shingles appeared on the same side of the body where the vaccine was administered. Patient was treated with unspecified antiviral medication for Shingles starting on 19-FEB-2021.

Other Meds: GABAPENTIN; LEVOTHYROXINE; PANTOPRAZOLE; LAMOTRIGINE; ASPIRIN CUPAL [ACETYLSALICYLIC ACID]; PAROXETINE

Current Illness:

ID: 1560352
Sex: F
Age: 66
State: TN

Vax Date: 02/26/2021
Onset Date: 02/28/2021
Rec V Date: 08/15/2021
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Symptoms: Abdominal cramps; Sweating; headache; nausea; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN (Abdominal cramps), HYPERHIDROSIS (Sweating), HEADACHE (headache), NAUSEA (nausea) and FATIGUE (fatigue) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination. No Medical History information was reported. On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced ABDOMINAL PAIN (Abdominal cramps), HYPERHIDROSIS (Sweating), HEADACHE (headache), NAUSEA (nausea) and FATIGUE (fatigue). On 02-Mar-2021, ABDOMINAL PAIN (Abdominal cramps), HYPERHIDROSIS (Sweating), HEADACHE (headache), NAUSEA (nausea) and FATIGUE (fatigue) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant and treatment drugs were reported.

Other Meds:

Current Illness:

ID: 1560353
Sex: F
Age: 37
State: IL

Vax Date: 02/21/2021
Onset Date: 02/21/2021
Rec V Date: 08/15/2021
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Symptoms: Injection arm going to sleep; Itchiness at the injection site; redness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Injection arm going to sleep), VACCINATION SITE PRURITUS (Itchiness at the injection site) and VACCINATION SITE ERYTHEMA (redness at the injection site) in a 37-year-old female patient 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 21-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Itchiness at the injection site) and VACCINATION SITE ERYTHEMA (redness at the injection site). On 01-Mar-2021, the patient experienced VACCINATION COMPLICATION (Injection arm going to sleep). In February 2021, VACCINATION SITE PRURITUS (Itchiness at the injection site) and VACCINATION SITE ERYTHEMA (redness at the injection site) had resolved. At the time of the report, VACCINATION COMPLICATION (Injection arm going to sleep) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications reported. Treatment medications was not provided by the reporter

Other Meds:

Current Illness:

ID: 1560354
Sex: M
Age: 74
State: MN

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

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Symptoms: Extremely achy; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Extremely achy) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included COVID-19. On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced PAIN (Extremely achy). On 27-Feb-2021, PAIN (Extremely achy) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications reported. Treatment medications was not provided by the reporter

Other Meds:

Current Illness:

ID: 1560355
Sex: F
Age: 75
State: OH

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

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Symptoms: Rash on arm localized; Swelling; A spontaneous report was received from a consumer concerning a 75-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events swelling, rash on arm localized. The patient's medical history was not provided. No relevant concomitant medications were reported. On unknown date, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 013M20A) intramuscularly for prophylaxis of COVID-19 infection. On 15 Feb 2021, the patient experienced the event(s) swelling. On 28 Feb 2021, the patient experienced the event(s) rash on arm localized. Treatment details included No HCP consulted. Action taken with mRNA-1273 in response to the events was not reported. On 17 Feb 2021 the outcome of event(s), swelling was resolved. On28 Feb 2021 the outcome of event(s), rash on arm localized was resolved.

Other Meds:

Current Illness:

ID: 1560356
Sex: F
Age:
State: IL

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

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Symptoms: pin-prickly-like tingling on her back; hot on her arm at the injection; felt a little bit of nausea; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (pin-prickly-like tingling on her back), VACCINATION SITE WARMTH (hot on her arm at the injection) and NAUSEA (felt a little bit of nausea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 26-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PARAESTHESIA (pin-prickly-like tingling on her back), VACCINATION SITE WARMTH (hot on her arm at the injection) and NAUSEA (felt a little bit of nausea). At the time of the report, PARAESTHESIA (pin-prickly-like tingling on her back), VACCINATION SITE WARMTH (hot on her arm at the injection) and NAUSEA (felt a little bit of nausea) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications reported. Treatment medications was not provided by the reporter

Other Meds:

Current Illness:

ID: 1560357
Sex: F
Age: 72
State: FL

Vax Date: 01/30/2021
Onset Date: 01/30/2021
Rec V Date: 08/15/2021
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Symptoms: Soreness at the injection site post first dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Soreness at the injection site post first dose) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination. No Medical History information was reported. On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, the patient experienced VACCINATION SITE PAIN (Soreness at the injection site post first dose). At the time of the report, VACCINATION SITE PAIN (Soreness at the injection site post first dose) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications reported. Treatment medications was not provided by the reporter This case was linked to MOD-2021-030677.

Other Meds:

Current Illness:

ID: 1560358
Sex: F
Age:
State: OK

Vax Date: 02/23/2021
Onset Date: 02/23/2021
Rec V Date: 08/15/2021
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Symptoms: coughing up a phlegm, spitting up phlegm; body aches; headache; chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCTIVE COUGH (coughing up a phlegm, spitting up phlegm), PAIN (body aches), HEADACHE (headache), CHILLS (chills) and PYREXIA (fever) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. D24M20A) for COVID-19 vaccination. Concurrent medical conditions included Heart disease, unspecified. On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced PAIN (body aches), HEADACHE (headache), CHILLS (chills) and PYREXIA (fever). On an unknown date, the patient experienced PRODUCTIVE COUGH (coughing up a phlegm, spitting up phlegm). On 26-Feb-2021, PAIN (body aches), HEADACHE (headache), CHILLS (chills) and PYREXIA (fever) had resolved. At the time of the report, PRODUCTIVE COUGH (coughing up a phlegm, spitting up phlegm) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Patient's concomitant medication included unspecified heart medication. Treatment medications was not provided by the reporter

Other Meds:

Current Illness:

ID: 1560359
Sex: U
Age:
State: IL

Vax Date: 02/24/2021
Onset Date:
Rec V Date: 08/15/2021
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Symptoms: urinary frequency; urinary urgency; chills; This spontaneous case was reported by a consumer and describes the occurrence of POLLAKIURIA (urinary frequency), MICTURITION URGENCY (urinary urgency) and CHILLS (chills) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 24-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced POLLAKIURIA (urinary frequency), MICTURITION URGENCY (urinary urgency) and CHILLS (chills). At the time of the report, POLLAKIURIA (urinary frequency), MICTURITION URGENCY (urinary urgency) and CHILLS (chills) outcome was unknown. No concomitant medications reported. Treatment medications was not provided by the reporter Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1560360
Sex: F
Age:
State: FL

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

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Symptoms: UTI; This spontaneous case was reported by a consumer and describes the occurrence of URINARY TRACT INFECTION (UTI) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced URINARY TRACT INFECTION (UTI). At the time of the report, URINARY TRACT INFECTION (UTI) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No Concomitant and treatment medications were provided. Patient has no side effects after receiving first dose of moderna vaccine. Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: Non significant follow up:NNI

Other Meds:

Current Illness:

ID: 1560361
Sex: F
Age: 59
State: UT

Vax Date: 01/16/2021
Onset Date: 02/22/2021
Rec V Date: 08/15/2021
Hospital:

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Symptoms: Dizziness when laying down, and sitting up; headaches; chills; body aches; in the fog; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body aches), FEELING ABNORMAL (in the fog), DIZZINESS (Dizziness when laying down, and sitting up), HEADACHE (headaches) and CHILLS (chills) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. No medical history was reported. Concomitant products included CALCIUM from 01-Jan-2013 to an unknown date for Calcium supplementation, MAGNESIUM from 01-Jan-2013 to an unknown date for Magnesium supplementation, COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) from 01-Jan-2013 to an unknown date for Supplementation therapy, ZINC from 01-Jan-2013 to an unknown date for Zinc supplementation. On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, the patient experienced DIZZINESS (Dizziness when laying down, and sitting up). On an unknown date, the patient experienced PAIN (body aches), FEELING ABNORMAL (in the fog), HEADACHE (headaches) and CHILLS (chills). On 29-Mar-2021, DIZZINESS (Dizziness when laying down, and sitting up) had resolved. At the time of the report, PAIN (body aches), FEELING ABNORMAL (in the fog), HEADACHE (headaches) and CHILLS (chills) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. On an unknown date, Blood pressure tests and EKG's were performed. Blood work was done. Ears were inspected and lung and heart were listened to. Patient's blood pressure for 2 weeks and the ranges were normal most of the time with some elevated readings. Everything was normal, there were no findings. No treatment medications were reported. Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: Patient characteristics have updated. Concomitant drugs includes vitamin D, calcium, mag, zinc have been updated. Outcome of the event dizziness has updated

Other Meds: CALCIUM; MAGNESIUM; ZINC; VITAMIN D [COLECALCIFEROL]

Current Illness:

ID: 1560362
Sex: M
Age: 60
State: PA

Vax Date: 02/16/2021
Onset Date: 02/17/2021
Rec V Date: 08/15/2021
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Symptoms: Skin dry after 1st dose; Skin itchy after 1st dose; Did not get the 2nd dose; shoulders and arms have some red zones on them; full body rash; full body rash, like a sunburn; it's not peeling but it's like flaking off/ skin flaked like dandruff; their skin like stings; their torso was completely red; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RASH ERYTHEMATOUS (full body rash, like a sunburn), SKIN EXFOLIATION (it's not peeling but it's like flaking off/ skin flaked like dandruff), PAIN OF SKIN (their skin like stings), ERYTHEMA (their torso was completely red) and ERYTHEMA (shoulders and arms have some red zones on them) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Cancer and Myeloma. Concomitant products included BORTEZOMIB (VELCADE) for Cancer, PROCHLORPERAZINE for Nausea, GABAPENTIN, LANSOPRAZOLE, ACETYLSALICYLIC ACID (BABY ASPIRIN), CALCIUM, ATORVASTATIN, DEXAMETHASONE and ACICLOVIR 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 17-Feb-2021, the patient experienced RASH ERYTHEMATOUS (full body rash, like a sunburn), SKIN EXFOLIATION (it's not peeling but it's like flaking off/ skin flaked like dandruff), PAIN OF SKIN (their skin like stings), ERYTHEMA (their torso was completely red) and RASH (full body rash). On 22-Feb-2021, the patient experienced ERYTHEMA (shoulders and arms have some red zones on them). On an unknown date, the patient experienced DRY SKIN (Skin dry after 1st dose), PRURITUS (Skin itchy after 1st dose) and PRODUCT DOSE OMISSION ISSUE (Did not get the 2nd dose). In April 2021, SKIN EXFOLIATION (it's not peeling but it's like flaking off/ skin flaked like dandruff) had resolved. At the time of the report, RASH ERYTHEMATOUS (full body rash, like a sunburn), PAIN OF SKIN (their skin like stings), ERYTHEMA (their torso was completely red), ERYTHEMA (shoulders and arms have some red zones on them) and RASH (full body rash) outcome was unknown, DRY SKIN (Skin dry after 1st dose) and PRURITUS (Skin itchy after 1st dose) had not resolved and PRODUCT DOSE OMISSION ISSUE (Did not get the 2nd dose) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. The patient developed full body rash, like a sunburn, which started on their back and went to their chest and stomach. The rash was not peeling but was like flaking off, and later the rash was on their legs, arms, head and shoulder. Patient's skin was like stings and reported that he just had chemotherapy the same day and injection BORTEZOMIB for cancer. Patient's torso that got the rash first was completely red, and was not peeling anymore at the time of reporting, but their shoulders and arms were peeling, with some red zones on them. Patient's cancer doctor prescribed an unspecified steroid but reported that it did not do anything for the rash. Patient additionally reported in 14-APR-2021 that, his skin flaked like dandruff for about 7 weeks after the first dose. Patient's skin was still dry and itchy, at the time of report but was not shedding anymore. Patient reported to be using Vaseline like lotion to keep it moisturized. Patient also reported that he did not get the second dose as nobody would tell him if he should or not. Most recent FOLLOW-UP information incorporated above includes: On 01-Mar-2021: Follow up report included no new information On 14-Apr-2021: Follow up report included details of the events and outcome.

Other Meds: VELCADE; GABAPENTIN; LANSOPRAZOLE; BABY ASPIRIN; CALCIUM; ATORVASTATIN; PROCHLORPERAZINE; DEXAMETHASONE; ACICLOVIR

Current Illness: Cancer; Myeloma

ID: 1560363
Sex: F
Age: 73
State: TN

Vax Date: 03/01/2021
Onset Date: 03/01/2021
Rec V Date: 08/15/2021
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Symptoms: blurring in my right eye; woke with a bad throb in the right side of my head; heart was racing/fast heartbeat; left eye began twitching with sharp pains; left eye began twitching with sharp pains; tingling in lips; left eye felt very dry; left side of my neck felt sore/ got a tight feeling; left eye had begun to water; left side of my face had swollen; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA ORAL (tingling in lips), ABNORMAL SENSATION IN EYE (left eye felt very dry), NECK PAIN (left side of my neck felt sore/ got a tight feeling), LACRIMATION INCREASED (left eye had begun to water) and SWELLING FACE (left side of my face had swollen) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced PARAESTHESIA ORAL (tingling in lips), ABNORMAL SENSATION IN EYE (left eye felt very dry), NECK PAIN (left side of my neck felt sore/ got a tight feeling), LACRIMATION INCREASED (left eye had begun to water) and SWELLING FACE (left side of my face had swollen). On 05-Mar-2021, the patient experienced BLEPHAROSPASM (left eye began twitching with sharp pains) and EYE PAIN (left eye began twitching with sharp pains). On 30-Mar-2021, the patient experienced PALPITATIONS (heart was racing/fast heartbeat) and HEADACHE (woke with a bad throb in the right side of my head). On an unknown date, the patient experienced VISION BLURRED (blurring in my right eye). On 30-Mar-2021, HEADACHE (woke with a bad throb in the right side of my head) had resolved. In April 2021, SWELLING FACE (left side of my face had swollen) had resolved. At the time of the report, PARAESTHESIA ORAL (tingling in lips), ABNORMAL SENSATION IN EYE (left eye felt very dry), NECK PAIN (left side of my neck felt sore/ got a tight feeling), LACRIMATION INCREASED (left eye had begun to water) and VISION BLURRED (blurring in my right eye) outcome was unknown and PALPITATIONS (heart was racing/fast heartbeat), BLEPHAROSPASM (left eye began twitching with sharp pains) and EYE PAIN (left eye began twitching with sharp pains) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications reported. After 15 mins of vaccination, patient's lips began to tingle, left eye felt very dry and left side of my neck felt sore. After about 30 mins, patient's left eye had begun to water and the left side of my face had swollen. After four days of vaccination, patient's left eye began twitching with sharp pains, which patient experience often at the time of report. Patient also had blurring in right eye. On 30-MAR-2021, patient woke with a bad throb in the right side of head and heart was racing. After a few mins it cleared up, but patient had the fast heartbeat often, at the time of report. Treatment medications was not provided by the reporter Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Follow up report included additional event details

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Current Illness:

ID: 1560364
Sex: F
Age:
State: NV

Vax Date: 01/21/2021
Onset Date: 02/25/2021
Rec V Date: 08/15/2021
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Symptoms: Flu like symptoms; very hot to touch; Vaccination site itchy; Headache; Injection site was very red; Injection site rash; This spontaneous case was reported by a patient and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), VACCINATION SITE WARMTH (very hot to touch), VACCINATION SITE PRURITUS (Vaccination site itchy), HEADACHE (Headache) and VACCINATION SITE ERYTHEMA (Injection site was very red) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was provided by the reporter. Concomitant products included INSULIN GLARGINE (LANTUS), METOPROLOL TARTRATE, AMLODIPINE, OMEPRAZOLE, PIOGLITAZONE, HYDROCHLOROTHIAZIDE, GLIPIZIDE and TRAZODONE for an unknown indication. On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), VACCINATION SITE WARMTH (very hot to touch), VACCINATION SITE PRURITUS (Vaccination site itchy), HEADACHE (Headache), VACCINATION SITE ERYTHEMA (Injection site was very red) and VACCINATION SITE RASH (Injection site rash). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms), VACCINATION SITE WARMTH (very hot to touch), VACCINATION SITE PRURITUS (Vaccination site itchy), HEADACHE (Headache), VACCINATION SITE ERYTHEMA (Injection site was very red) and VACCINATION SITE RASH (Injection site rash) had resolved. Patient reported that the side effects healed after couple of days. Treatment medications was not provided by the reporter This case was linked to MOD-2021-030690 (Patient Link).

Other Meds: LANTUS; METOPROLOL TARTRATE; AMLODIPINE; OMEPRAZOLE; PIOGLITAZONE; HYDROCHLOROTHIAZIDE; GLIPIZIDE; TRAZODONE

Current Illness:

ID: 1560365
Sex: M
Age: 73
State:

Vax Date: 02/25/2021
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Rec V Date: 08/15/2021
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Symptoms: pain in groin; This spontaneous case was reported by a non-health professional and describes the occurrence of GROIN PAIN (pain in groin) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination. No medical history was provided by the reporter. Concomitant products included PREDNISONE for an unknown indication. On 25-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced GROIN PAIN (pain in groin). At the time of the report, GROIN PAIN (pain in groin) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. This spontaneous case was reported by a and describes the occurrence of GROIN PAIN (pain in groin) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included No adverse event. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced GROIN PAIN (pain in groin). At the time of the report, GROIN PAIN (pain in groin) outcome was unknown. Patient take Amoxicillin and Prednisone as a Concomitant medication. Reporter did not allow further contact

Other Meds: PREDNISONE

Current Illness:

ID: 1560366
Sex: M
Age:
State: MA

Vax Date: 02/07/2021
Onset Date: 02/18/2021
Rec V Date: 08/15/2021
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Symptoms: Patient experienced headache 1 & 1/2 week after receiving 1st dose; This spontaneous case was reported by a patient family member or friend and describes the occurrence of HEADACHE (Patient experienced headache 1 & 1/2 week after receiving 1st dose) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination. The patient's past medical history included Surgery (Unspecified other surgery). Concomitant products included IBUPROFEN (ADVIL 12 HOUR) for Surgery. On 07-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 18-Feb-2021, the patient experienced HEADACHE (Patient experienced headache 1 & 1/2 week after receiving 1st dose). At the time of the report, HEADACHE (Patient experienced headache 1 & 1/2 week after receiving 1st dose) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Patient did not take any treatment for the event

Other Meds: ADVIL 12 HOUR

Current Illness:

ID: 1560367
Sex: F
Age: 84
State: NY

Vax Date: 02/15/2021
Onset Date: 02/15/2021
Rec V Date: 08/15/2021
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Symptoms: generalized itching; feeling of tightness of throat; shortness of breath; This spontaneous case was reported by a physician and describes the occurrence of PRURITUS (generalized itching), THROAT TIGHTNESS (feeling of tightness of throat) and DYSPNOEA (shortness of breath) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included No adverse event. Concomitant products included FEXOFENADINE, ALPRAZOLAM, CARVEDILOL, VITAMIN B12 (CYANOCOBALAMIN AND ANALOGUES), Esterase, THIOPHENE and USTELL for an unknown indication. On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced PRURITUS (generalized itching), THROAT TIGHTNESS (feeling of tightness of throat) and DYSPNOEA (shortness of breath). On 15-Feb-2021, THROAT TIGHTNESS (feeling of tightness of throat) and DYSPNOEA (shortness of breath) had resolved. At the time of the report, PRURITUS (generalized itching) 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: FEXOFENADINE; ALPRAZOLAM; CARVEDILOL; VITAMIN B12 (CYANOCOBALAMIN AND ANALOGUES); Esterase; THIOPHENE; USTELL

Current Illness:

ID: 1560368
Sex: M
Age:
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Vax Date: 02/02/2021
Onset Date: 02/02/2021
Rec V Date: 08/15/2021
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Symptoms: Tired; Fatigued; This spontaneous case was reported by a patient and describes the occurrence of FATIGUE (Tired) and FATIGUE (Fatigued) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, the patient experienced FATIGUE (Tired) and FATIGUE (Fatigued). At the time of the report, FATIGUE (Tired) and FATIGUE (Fatigued) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications reported. Treatment medications was not provided by the reporter

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Current Illness:

ID: 1560369
Sex: F
Age: 72
State: FL

Vax Date: 01/30/2021
Onset Date: 03/01/2021
Rec V Date: 08/15/2021
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Symptoms: 2.5-3 inch hard spot on her arm (half the size of a tennis ball); Swelling and redness in the injection site; Swelling and redness in the injection site; More painful/soreness at the injection site post first dose; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE REACTION (2.5-3 inch hard spot on her arm (half the size of a tennis ball)), INJECTION SITE SWELLING (Swelling and redness in the injection site), INJECTION SITE ERYTHEMA (Swelling and redness in the injection site) and INJECTION SITE PAIN (More painful/soreness at the injection site post first dose) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 030L20A) for COVID-19 vaccination. No Medical History information was reported. On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Mar-2021, the patient experienced INJECTION SITE REACTION (2.5-3 inch hard spot on her arm (half the size of a tennis ball)). 01-Mar-2021, the patient experienced INJECTION SITE SWELLING (Swelling and redness in the injection site), INJECTION SITE ERYTHEMA (Swelling and redness in the injection site) and INJECTION SITE PAIN (More painful/soreness at the injection site post first dose). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) on 28-Feb-2021 for Injection site reaction, at a dose of 1 dosage form. At the time of the report, INJECTION SITE REACTION (2.5-3 inch hard spot on her arm (half the size of a tennis ball)), INJECTION SITE SWELLING (Swelling and redness in the injection site), INJECTION SITE ERYTHEMA (Swelling and redness in the injection site) and INJECTION SITE PAIN (More painful/soreness at the injection site post first dose) had not resolved. As treatment patient also applied ice but with no relief This case was linked to MOD-2021-030659 (Patient Link).

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Current Illness:

ID: 1560370
Sex: F
Age: 67
State: FL

Vax Date: 02/25/2021
Onset Date: 02/25/2021
Rec V Date: 08/15/2021
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Symptoms: arm was sore at the injection site; hot at the injection site; red at injection site; face got red & blotchy; neck got red & blotchy; mouth got very dry; throat tightened up; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (face got red & blotchy), ERYTHEMA (neck got red & blotchy), PAIN IN EXTREMITY (arm was sore at the injection site), DRY MOUTH (mouth got very dry) and VACCINATION SITE WARMTH (hot at the injection site) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced DRY MOUTH (mouth got very dry) and THROAT TIGHTNESS (throat tightened up). On 25-Feb-2021 at 12:05 AM, the patient experienced ERYTHEMA (face got red & blotchy) and ERYTHEMA (neck got red & blotchy). On 26-Feb-2021, the patient experienced PAIN IN EXTREMITY (arm was sore at the injection site), VACCINATION SITE WARMTH (hot at the injection site) and VACCINATION SITE ERYTHEMA (red at injection site). At the time of the report, ERYTHEMA (face got red & blotchy), ERYTHEMA (neck got red & blotchy), PAIN IN EXTREMITY (arm was sore at the injection site), DRY MOUTH (mouth got very dry), VACCINATION SITE WARMTH (hot at the injection site), THROAT TIGHTNESS (throat tightened up) and VACCINATION SITE ERYTHEMA (red at injection site) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications reported. Treatment medications was not provided by the reporter

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Current Illness:

ID: 1560371
Sex: F
Age:
State: TX

Vax Date:
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Rec V Date: 08/15/2021
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Symptoms: bad reaction to the second shot; friend is female and she had to lied in bed all day; Fatigue; headache; pain in arm; migraine; muscle pain; Malaise; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (bad reaction to the second shot), BEDRIDDEN (friend is female and she had to lied in bed all day), FATIGUE (Fatigue), HEADACHE (headache) and PAIN IN EXTREMITY (pain in arm) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event. Concomitant products included PROLIFE for Asthma, ASCORBIC ACID, VITAMIN D3, ZINC and VITAMIN B COMPLEX for an unknown indication. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 2 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (bad reaction to the second shot), BEDRIDDEN (friend is female and she had to lied in bed all day), FATIGUE (Fatigue), HEADACHE (headache), PAIN IN EXTREMITY (pain in arm), MIGRAINE (migraine), MYALGIA (muscle pain) and MALAISE (Malaise). At the time of the report, VACCINATION COMPLICATION (bad reaction to the second shot), BEDRIDDEN (friend is female and she had to lied in bed all day), FATIGUE (Fatigue), HEADACHE (headache), PAIN IN EXTREMITY (pain in arm), MIGRAINE (migraine), MYALGIA (muscle pain) and MALAISE (Malaise) outcome was unknown.

Other Meds: ASCORBIC ACID; VITAMIN D3; ZINC; VITAMIN B COMPLEX; PROLIFE

Current Illness:

ID: 1560372
Sex: F
Age: 91
State: FL

Vax Date: 02/05/2021
Onset Date: 02/05/2021
Rec V Date: 08/15/2021
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Symptoms: cried out in pain; she did sleep a lot for the next three days; Abdominal pain/Extreme abdominal Pain; This spontaneous case was reported by a patient family member or friend and describes the occurrence of ABDOMINAL PAIN (Abdominal pain/Extreme abdominal Pain), PAIN (cried out in pain) and SOMNOLENCE (she did sleep a lot for the next three days) in a 91-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination. The patient's past medical history included Aortic valve replacement on 11-Jun-2014. Concurrent medical conditions included Diabetic since 2011, Dementia (dramatic memory change after 4/04/2021) in December 2012, Congestive heart failure since 14-Oct-2011 and AFib since 03-Sep-2011. Concomitant products included OMEPRAZOLE SODIUM (OMEPRAZOLE [OMEPRAZOLE SODIUM]) from 01-Apr-2021 to an unknown date for Abdominal pain, DIGOXIN from 12-Jun-2017 to an unknown date for Atrial fibrillation, PARACETAMOL (TYLENOL REGULAR) for Back pain, METOPROLOL SUCCINATE from 28-Jun-2017 to an unknown date and DILTIAZEM HYDROCHLORIDE (DILTIAZEM HCL CD) from 21-Jul-2020 to an unknown date for Blood pressure, DONEPEZIL HCL from 22-Apr-2014 to an unknown date for Dementia, SITAGLIPTIN PHOSPHATE (JANUVIA) from 06-Oct-2018 to an unknown date for Diabetes, PRIMIDONE from 08-May-2012 to an unknown date for Tremor, NITROFURANTOIN from 08-Aug-2020 to an unknown date for UTI, TORSEMIDE from 07-Oct-2011 to an unknown date for Water retention, CENTRUM SILVER +50 from 11-Jul-2014 to an unknown date, CALCIUM CARBONATE, ERGOCALCIFEROL (OSCAL 500 + D) from 17-Jul-2014 to an unknown date and LEVOTHYROXINE SODIUM (SYNTHROID) from 12-Jun-2017 to an unknown date for an unknown indication. On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced ABDOMINAL PAIN (Abdominal pain/Extreme abdominal Pain). On an unknown date, the patient experienced PAIN (cried out in pain) and SOMNOLENCE (she did sleep a lot for the next three days). The patient was treated with CALCIUM CARBONATE (TUMS [CALCIUM CARBONATE]) (oral) 05-Feb-2021 for Abdominal pain, at a dose of 1 dosage form. On 07-Feb-2021, ABDOMINAL PAIN (Abdominal pain/Extreme abdominal Pain) had resolved. At the time of the report, PAIN (cried out in pain) and SOMNOLENCE (she did sleep a lot for the next three days) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Patient contacted her primary doctor who performed UTI testing and sugar levels.No issues were found. Concomitant medications included Digestive Probiotic given AM 1Pill Preventative help with Antibiotics Started 15 Aug 2020, and Diabetes Type dose Changed from 04 2021 to 2 pills per family doctor Started 06 0ct 2018 This case was linked to MOD-2021-262745 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: Follow up report included reporters contact details On 21-Jul-2021: Follow-up information received on 21 Jul 2021 contains significant information. updated reporter information, added patient demographics, added medical history vascular dementia, AFIB, CHF,TAVR, diabetic. Added concomitants Omeprazole ,Centrum-50, Digoxin, Metoprolol, Oscal, Primidone, Tylenol, Donepezil Hcl, Diltiazem Hcl , nitrofurantoin , Januvia, . event abdominal pain stop dated updated 07 Feb 2021. Added events pain and sleepy.

Other Meds: OMEPRAZOLE [OMEPRAZOLE SODIUM]; CENTRUM SILVER +50; DIGOXIN; METOPROLOL SUCCINATE; OSCAL 500 + D; PRIMIDONE; TORSEMIDE; TYLENOL REGULAR; DONEPEZIL HCL; NITROFURANTOIN; JANUVIA; DILTIAZEM HCL CD; SYNTHROID

Current Illness: AFib; Congestive heart failure; Diabetic

ID: 1560373
Sex: F
Age: 80
State: AZ

Vax Date: 02/03/2021
Onset Date: 03/01/2021
Rec V Date: 08/15/2021
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Symptoms: COVID arm; Raised Bump; injection arm ache; Red circle; Injection arm ache; neck ache; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (neck ache), VACCINATION SITE REACTION (COVID arm), INJECTION SITE MASS (Raised Bump), PAIN IN EXTREMITY (Injection arm ache) and INJECTION SITE PAIN (injection arm ache) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 032M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Mar-2021, the patient experienced NECK PAIN (neck ache) and PAIN IN EXTREMITY (Injection arm ache). On an unknown date, the patient experienced VACCINATION SITE REACTION (COVID arm), INJECTION SITE MASS (Raised Bump), INJECTION SITE PAIN (injection arm ache) and INJECTION SITE ERYTHEMA (Red circle). At the time of the report, NECK PAIN (neck ache) and PAIN IN EXTREMITY (Injection arm ache) had not resolved, VACCINATION SITE REACTION (COVID arm) outcome was unknown and INJECTION SITE MASS (Raised Bump), INJECTION SITE PAIN (injection arm ache) and INJECTION SITE ERYTHEMA (Red circle) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided by the reporter. Treatment of the events include, Ibuprofen and naproxen. This case was linked to US-MODERNATX, INC.-MOD-2021-098624 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: Follow up information was received on 29 Apr 2021, include, contact details, date of second dose administration and events.; Sender's Comments: US-MODERNATX, INC.-MOD-2021-098624:Case created for second dose

Other Meds:

Current Illness:

ID: 1560374
Sex: F
Age: 70
State: IN

Vax Date: 01/29/2021
Onset Date:
Rec V Date: 08/15/2021
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Symptoms: bad itching; Redness; rash; circle of rash 3 or 4 inches below the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (bad itching), ERYTHEMA (Redness), RASH (rash) and INJECTION SITE RASH (circle of rash 3 or 4 inches below the injection site) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030620A) for COVID-19 vaccination. The patient's past medical history included No adverse event. On 29-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 PRURITUS (bad itching), ERYTHEMA (Redness), RASH (rash) and INJECTION SITE RASH (circle of rash 3 or 4 inches below the injection site). At the time of the report, PRURITUS (bad itching), ERYTHEMA (Redness), RASH (rash) and INJECTION SITE RASH (circle of rash 3 or 4 inches below the injection site) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications reported by investigator No treatment medications provided by the reporter.

Other Meds:

Current Illness:

ID: 1560375
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/15/2021
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Symptoms: Arm pain; Muscle soreness; Slight fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm pain), MYALGIA (Muscle soreness) and PYREXIA (Slight fever) 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 (No reported medical history). 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 PAIN IN EXTREMITY (Arm pain), MYALGIA (Muscle soreness) and PYREXIA (Slight fever). At the time of the report, PAIN IN EXTREMITY (Arm pain), MYALGIA (Muscle soreness) and PYREXIA (Slight fever) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications reported by investigator No treatment medications provided by the reporter.

Other Meds:

Current Illness:

ID: 1560376
Sex: F
Age:
State:

Vax Date: 02/26/2021
Onset Date: 02/27/2021
Rec V Date: 08/15/2021
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Symptoms: not able to eat; light headed; high blood pressure; nauseous; arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was sore), DECREASED APPETITE (not able to eat), DIZZINESS (light headed), HYPERTENSION (high blood pressure) and NAUSEA (nauseous) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Type 2 diabetes mellitus. Concomitant products included SEMAGLUTIDE (OZEMPIC) for Type 2 diabetes mellitus. On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, the patient experienced PAIN IN EXTREMITY (arm was sore). On 28-Feb-2021, the patient experienced DECREASED APPETITE (not able to eat), DIZZINESS (light headed), HYPERTENSION (high blood pressure) and NAUSEA (nauseous). At the time of the report, PAIN IN EXTREMITY (arm was sore), DECREASED APPETITE (not able to eat), DIZZINESS (light headed), HYPERTENSION (high blood pressure) and NAUSEA (nauseous) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No treatment medications provided by the reporter.

Other Meds: OZEMPIC

Current Illness: Type 2 diabetes mellitus

ID: 1560377
Sex: U
Age:
State: PA

Vax Date:
Onset Date:
Rec V Date: 08/15/2021
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Symptoms: Patient got COVID after the first dose of the vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of SARS-COV-2 TEST POSITIVE (Patient got COVID after the first dose of the vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SARS-COV-2 TEST POSITIVE (Patient got COVID after the first dose of the vaccine). At the time of the report, SARS-COV-2 TEST POSITIVE (Patient got COVID after the first dose of the vaccine) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) got COVID after the first dose of the vaccine. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medication and treatment drug were not reported.

Other Meds:

Current Illness:

ID: 1560378
Sex: F
Age: 70
State: FL

Vax Date: 01/22/2021
Onset Date: 01/22/2021
Rec V Date: 08/15/2021
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Symptoms: Pain in arm at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain in arm at injection site) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced VACCINATION SITE PAIN (Pain in arm at injection site). The patient was treated with NAPROXEN at a dose of 1 dosage form. At the time of the report, VACCINATION SITE PAIN (Pain in arm at injection site) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. .

Other Meds:

Current Illness:

ID: 1560379
Sex: F
Age: 60
State: OK

Vax Date: 03/01/2021
Onset Date: 03/01/2021
Rec V Date: 08/15/2021
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Symptoms: The site of injection itching; the site of injection is swelling; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PRURITUS (The site of injection itching) and INJECTION SITE SWELLING (the site of injection is swelling) in a 60-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 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced INJECTION SITE PRURITUS (The site of injection itching) and INJECTION SITE SWELLING (the site of injection is swelling). At the time of the report, INJECTION SITE PRURITUS (The site of injection itching) and INJECTION SITE SWELLING (the site of injection is swelling) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No relevant concomitant medications were reported. No treatment information was provided.

Other Meds:

Current Illness:

ID: 1560380
Sex: F
Age: 71
State: OK

Vax Date: 02/28/2021
Onset Date: 02/28/2021
Rec V Date: 08/15/2021
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Symptoms: Fever; Redness; Swelling; Hotness; Itchiness; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), ERYTHEMA (Redness), SWELLING (Swelling), FEELING HOT (Hotness) and PRURITUS (Itchiness) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination. No Medical History information was reported. On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced PYREXIA (Fever), ERYTHEMA (Redness), SWELLING (Swelling), FEELING HOT (Hotness) and PRURITUS (Itchiness). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PYREXIA (Fever), ERYTHEMA (Redness), SWELLING (Swelling), FEELING HOT (Hotness) and PRURITUS (Itchiness) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No relevant concomitant medications were reported.

Other Meds:

Current Illness:

ID: 1560381
Sex: F
Age:
State: NJ

Vax Date: 02/27/2021
Onset Date:
Rec V Date: 08/15/2021
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Symptoms: Dizziness; Vomiting; Chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), VOMITING (Vomiting), CHILLS (Chills) and HEADACHE (Headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Dizziness), VOMITING (Vomiting), CHILLS (Chills) and HEADACHE (Headache). At the time of the report, DIZZINESS (Dizziness), VOMITING (Vomiting), CHILLS (Chills) and HEADACHE (Headache) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.

Other Meds:

Current Illness:

ID: 1560382
Sex: F
Age: 69
State: TX

Vax Date: 01/13/2021
Onset Date: 02/27/2021
Rec V Date: 08/15/2021
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Symptoms: Had second shot outside of 42 day window; A spontaneous report was received from a consumer concerning a 69-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced second shot outside of 42 day window (Inappropriate schedule of vaccine administration). The patient's medical history, was not reported. Concomitant medications reported included bupropion, lamotrigine, Librium, progesterone/ estrogen, magnesium glycinate, deplin and suboxone. On 13 Jan 2021, prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (Lot number: 027L20A) intramuscularly for prophylaxis of COVID-19 infection. On 27 Feb 2021, prior to the onset of the events, the patient received the second of two planned doses of mRNA-1273 (Lot number: 012A21A) intramuscularly for prophylaxis of COVID-19 infection. Patient took second dose outside of 42 day window. No laboratory details was provided.No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the event, second shot outside of 42 day window, was considered as resolved on 27 Feb 2021.; Reporter's Comments: This report refers to a case of inappropriate schedule of vaccine administration for mRNA-1273, lot # 012A21A with no associated AEs.

Other Meds: BUPROPION; LAMOTRIGINE; LIBRIUM [CHLORDIAZEPOXIDE HYDROCHLORIDE]; MAGNESIUM GLYCINATE; DEPLIN [CALCIUM LEVOMEFOLATE]; SUBOXONE; ESTROGEN NOS;PROGESTERONE

Current Illness:

ID: 1560383
Sex: U
Age:
State: NJ

Vax Date: 02/10/2021
Onset Date:
Rec V Date: 08/15/2021
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Symptoms: Soreness of arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Soreness of arm) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 10-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (Soreness of arm). At the time of the report, MYALGIA (Soreness of arm) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.; Sender's Comments: Based on the available information and the temporal association between the use of the product and the event occurrence, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1560384
Sex: F
Age: 33
State: PA

Vax Date: 02/25/2021
Onset Date: 02/25/2021
Rec V Date: 08/15/2021
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Symptoms: Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) in a 33-year-old female patient (gravida 4, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination. The patient's past medical history included Miscarriage on 26-May-2017, Miscarriage on 15-Nov-2017, Depression, Anxiety, Degenerative disc disease in 2009, Stenosis in 2009, Spinal osteoarthritis in 2009, Alcohol use from 2003 to 2011 and Ex-smoker from 2006 to 2020. Concurrent medical conditions included Allergy to topical drugs (allergic to sulfa drugs) and Latex allergy. Concomitant products included VALACICLOVIR HYDROCHLORIDE (VALTREX) and VALACICLOVIR HYDROCHLORIDE (VALTREX) for Cold sores, MAGNESIUM for Headache and Constipation, MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for Pregnancy, ALCOHOL, NICOTINE and MARIJUANA. On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 02-Sep-2020 and the estimated date of delivery was 09-Jun-2021. On 25-Feb-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the twenty-fifth week of the pregnancy. On 25-Feb-2021, MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Sep-2020, Pregnancy test: positive (Positive) Positive. On 27-Sep-2020, Ultrasound antenatal screen: normal (normal) normal. 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. On a unknown dates, the patient reports having an ultrasound, NIPP, and genetic screening that resulted in normal findings.

Other Meds: PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]; VALTREX; VALTREX; MAGNESIUM; ALCOHOL; NICOTINE; MARIJUANA

Current Illness:

ID: 1560385
Sex: F
Age: 70
State: OH

Vax Date: 02/23/2021
Onset Date: 02/23/2021
Rec V Date: 08/15/2021
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Symptoms: Difficulty Breathing; Heart Palpitation for two and half days; Dizziness; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Difficulty Breathing), PALPITATIONS (Heart Palpitation for two and half days) and DIZZINESS (Dizziness) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 milliliter. On 23-Feb-2021, the patient experienced DYSPNOEA (Difficulty Breathing), PALPITATIONS (Heart Palpitation for two and half days) and DIZZINESS (Dizziness). At the time of the report, DYSPNOEA (Difficulty Breathing), PALPITATIONS (Heart Palpitation for two and half days) and DIZZINESS (Dizziness) outcome was unknown. Possible The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant was provided. Patient treatment information was not provided.

Other Meds:

Current Illness:

ID: 1560386
Sex: F
Age: 74
State: TN

Vax Date: 02/24/2021
Onset Date: 02/25/2021
Rec V Date: 08/15/2021
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Symptoms: Very Weak; Lightheaded; Low Blood Pressure 130/60 mmHg; High Resting Heart Rate 80 BPM.; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Very Weak), DIZZINESS (Lightheaded), HYPOTENSION (Low Blood Pressure 130/60 mmHg) and HEART RATE INCREASED (High Resting Heart Rate 80 BPM.) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID- 19 Immunisation. No Medical History information was reported. On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, the patient experienced ASTHENIA (Very Weak), DIZZINESS (Lightheaded), HYPOTENSION (Low Blood Pressure 130/60 mmHg) and HEART RATE INCREASED (High Resting Heart Rate 80 BPM.). At the time of the report, ASTHENIA (Very Weak), DIZZINESS (Lightheaded), HYPOTENSION (Low Blood Pressure 130/60 mmHg) and HEART RATE INCREASED (High Resting Heart Rate 80 BPM.) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: 80 80 BPM. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.

Other Meds:

Current Illness:

ID: 1560387
Sex: M
Age:
State:

Vax Date: 02/26/2021
Onset Date:
Rec V Date: 08/15/2021
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Symptoms: sore arm; very sleepy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore arm) and SOMNOLENCE (very sleepy) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (sore arm) and SOMNOLENCE (very sleepy). At the time of the report, VACCINATION SITE PAIN (sore arm) and SOMNOLENCE (very sleepy) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.

Other Meds:

Current Illness:

ID: 1560388
Sex: F
Age:
State:

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

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Symptoms: Nine days later she had a pruritic rash with urticaria lasting four days; Nine days later she had a pruritic rash with urticaria lasting four days; This spontaneous case was reported by a health care professional and describes the occurrence of RASH PRURITIC (Nine days later she had a pruritic rash with urticaria lasting four days) and URTICARIA (Nine days later she had a pruritic rash with urticaria lasting four days) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included No adverse event. On 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 RASH PRURITIC (Nine days later she had a pruritic rash with urticaria lasting four days) and URTICARIA (Nine days later she had a pruritic rash with urticaria lasting four days). At the time of the report, RASH PRURITIC (Nine days later she had a pruritic rash with urticaria lasting four days) and URTICARIA (Nine days later she had a pruritic rash with urticaria lasting four days) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.

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Current Illness:

ID: 1560389
Sex: F
Age: 61
State: FL

Vax Date: 02/16/2021
Onset Date: 03/02/2021
Rec V Date: 08/15/2021
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Symptoms: red ring around the injection site; soreness around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (red ring around the injection site) and VACCINATION SITE PAIN (soreness around the injection site) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, the patient experienced RASH ERYTHEMATOUS (red ring around the injection site) and VACCINATION SITE PAIN (soreness around the injection site). At the time of the report, RASH ERYTHEMATOUS (red ring around the injection site) and VACCINATION SITE PAIN (soreness around the injection site) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No relevant concomitant medications were reported. Treatment medications were not provided by reporter.

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Current Illness:

ID: 1560390
Sex: F
Age: 72
State: AL

Vax Date: 02/10/2021
Onset Date: 02/10/2021
Rec V Date: 08/15/2021
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Symptoms: sore arm; A spontaneous report was received from a consumer concerning a 72-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events sore arm. The patient's medical history was not provided. No relevant concomitant medications were reported. On 10 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 041L20A) via unknown route in the left arm for prophylaxis of COVID-19 infection. On 10 Feb 2021, the patient experienced the event(s) sore arm. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of event(s), sore arm was unknown.

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Current Illness:

ID: 1560391
Sex: F
Age: 55
State: OK

Vax Date: 02/03/2021
Onset Date: 02/01/2021
Rec V Date: 08/15/2021
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Symptoms: shingles; rash on her ribs on her front right side; pulled muscle; pain in her right back shoulder blade; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (shingles), PAIN (pain in her right back shoulder blade), RASH (rash on her ribs on her front right side) and MUSCLE STRAIN (pulled muscle) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20a) for COVID-19 vaccination. The patient's past medical history included No adverse event. On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced PAIN (pain in her right back shoulder blade) and MUSCLE STRAIN (pulled muscle). On 21-Feb-2021, the patient experienced RASH (rash on her ribs on her front right side). On 22-Feb-2021, the patient experienced HERPES ZOSTER (shingles). On 22-Feb-2021, MUSCLE STRAIN (pulled muscle) had resolved. At the time of the report, HERPES ZOSTER (shingles), PAIN (pain in her right back shoulder blade) and RASH (rash on her ribs on her front right side) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.

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Current Illness:

ID: 1560392
Sex: M
Age:
State:

Vax Date: 02/23/2021
Onset Date: 02/23/2021
Rec V Date: 08/15/2021
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Symptoms: did not feel well; headache; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (did not feel well) and HEADACHE (headache) 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 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, the patient experienced MALAISE (did not feel well) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at a dose of 1 dosage form. On 24-Feb-2021, MALAISE (did not feel well) and HEADACHE (headache) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Reporter did not allow further contact

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Current Illness:

ID: 1560393
Sex: F
Age: 70
State: TX

Vax Date: 01/27/2021
Onset Date: 02/13/2021
Rec V Date: 08/15/2021
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Symptoms: Left leg became really swollen to the point the skin was stretching; Leg was numb; Gums became very sensitive; Developed a rash on her arm; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Left leg became really swollen to the point the skin was stretching), HYPOAESTHESIA (Leg was numb), GINGIVAL PAIN (Gums became very sensitive) and INJECTION SITE RASH (Developed a rash on her arm) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination. No Medical History information was reported. On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced PERIPHERAL SWELLING (Left leg became really swollen to the point the skin was stretching), HYPOAESTHESIA (Leg was numb), GINGIVAL PAIN (Gums became very sensitive) and INJECTION SITE RASH (Developed a rash on her arm). At the time of the report, PERIPHERAL SWELLING (Left leg became really swollen to the point the skin was stretching), HYPOAESTHESIA (Leg was numb), GINGIVAL PAIN (Gums became very sensitive) and INJECTION SITE RASH (Developed a rash on her arm) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No relevant concomitant medications were reported. Treatment drugs include Steroid for 7 days for an unknown indication.

Other Meds:

Current Illness:

ID: 1560394
Sex: F
Age: 74
State: CA

Vax Date: 02/28/2021
Onset Date: 03/01/2021
Rec V Date: 08/15/2021
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Symptoms: Sharp ringing noise in ear still going; Little tired; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Sharp ringing noise in ear still going) and FATIGUE (Little tired) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Fish allergy and Tinnitus. On 28-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 01-Mar-2021, the patient experienced TINNITUS (Sharp ringing noise in ear still going) and FATIGUE (Little tired). At the time of the report, TINNITUS (Sharp ringing noise in ear still going) had not resolved and FATIGUE (Little tired) outcome was unknown. No relevant concomitant medications were reported. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not applicable.

Other Meds:

Current Illness:

ID: 1560395
Sex: M
Age: 73
State: AZ

Vax Date: 03/01/2021
Onset Date: 03/01/2021
Rec V Date: 08/15/2021
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Symptoms: Received an incorrectly stored vaccine; A spontaneous report was received from a consumer concerning a 73-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and reported receiving an incorrectly stored vaccine. The patient's medical history, was not reported. Concomitant medications was not reported. On 01 Mar 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025A21A)for prophylaxis of COVID-19 infection. On 01 Mar 2021, the patient was informed by the vaccination provider that his vaccine was stored incorrectly. No laboratory details was provided.No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the event, receiving an incorrectly stored vaccine , was considered resolved .; Reporter's Comments: This report refers to a case of Incorrectly stored vaccine for mRNA-1273, lot # 025A21A with no associated AEs.

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Current Illness:

Total 2021 VAERS Injuries: 639,999

Page last modified: 03 October 2021 5:28pm