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
92,076
AK1,880
AL6,345
AR4,151
AS46
AZ14,991
CA66,887
CO12,550
CT8,943
DC1,795
DE2,009
FL42,724
FM4
GA17,031
GU124
HI2,580
IA4,919
ID2,892
IL22,128
IN24,197
KS5,047
KY9,111
LA5,500
MA15,718
MD13,434
ME3,351
MH8
MI20,971
MN13,585
MO10,747
MP30
MS3,198
MT2,477
NC18,051
ND1,501
NE3,109
NH3,218
NJ20,216
NM4,218
NV4,728
NY37,667
OH20,793
OK6,692
OR9,244
PA25,607
PR2,588
QM2
RI2,163
SC7,261
SD1,282
TN10,445
TX39,890
UT4,618
VA15,980
VI67
VT1,830
WA16,071
WI12,042
WV2,571
WY926
XB5
XL1
XV2

ID: 1566810
Sex: M
Age: 60
State: NJ

Vax Date: 03/04/2021
Onset Date: 03/06/2021
Rec V Date: 08/15/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Dysphagia, Epiglottitis

Symptoms: Back Pain; Fatigue; Headache; Knee Pain/Shoulder Pain/Joint Pain; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Back Pain), FATIGUE (Fatigue), HEADACHE (Headache) and ARTHRALGIA (Knee Pain/Shoulder Pain/Joint Pain) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included Bronchitis (Hospitalized) since an unknown date. Concurrent medical conditions included Thyroid disorder NOS and Blood pressure fluctuation. On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced BACK PAIN (Back Pain), FATIGUE (Fatigue), HEADACHE (Headache) and ARTHRALGIA (Knee Pain/Shoulder Pain/Joint Pain). The patient was treated with NAPROXEN SODIUM (ALEVE) for Pain, at an unspecified dose and frequency. At the time of the report, BACK PAIN (Back Pain), FATIGUE (Fatigue), HEADACHE (Headache) and ARTHRALGIA (Knee Pain/Shoulder Pain/Joint Pain) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 antibody test: negative (Negative) negative. It was reported that patient was on thyroid and blood pressure medications. Before receiving the vaccination, patient was in a hospital for bronchitis and was on medication for 10 days. Action taken with mRNA-1273 in response to events was not applicable. This case was linked to US-MODERNATX, INC.-MOD-2021-108731 (E2B Linked Report). Reporter did not allow further contact Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: Second dose vaccine date was added.; Sender's Comments: US-MODERNATX, INC.-MOD-2021-108731:second dose case

Other Meds:

Current Illness: Blood pressure fluctuation; Bronchitis (Hospitalized); Thyroid disorder NOS

ID: 1566811
Sex: M
Age:
State:

Vax Date: 03/04/2021
Onset Date: 03/08/2021
Rec V Date: 08/15/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Anxiety, Dyspnoea

Symptoms: headache; sweaty; Feverish; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (sweaty), PYREXIA (Feverish) and HEADACHE (headache) 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 04-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, the patient experienced HYPERHIDROSIS (sweaty) and PYREXIA (Feverish). On 14-Mar-2021, the patient experienced HEADACHE (headache). At the time of the report, HYPERHIDROSIS (sweaty), PYREXIA (Feverish) and HEADACHE (headache) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No relevant concomitant medications were reported. Treatment information was not provided. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1566812
Sex: F
Age:
State: NY

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

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Chest discomfort, Dysphagia, Pain in extremity, Visual impairment

Symptoms: Night sweat; Injection site pain; This spontaneous case was reported by a consumer and describes the occurrence of NIGHT SWEATS (Night sweat) and VACCINATION SITE PAIN (Injection site pain) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038K20A and 010M20A) for COVID-19 vaccination. The patient's past medical history included No adverse reaction. On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Jan-2021, the patient experienced VACCINATION SITE PAIN (Injection site pain). On 25-Jan-2021, the patient experienced NIGHT SWEATS (Night sweat). On 25-Jan-2021, NIGHT SWEATS (Night sweat) and VACCINATION SITE PAIN (Injection site pain) had resolved. No concomitant medications were provided. Treatment information provided mentioned Tylenol, Zyrtec, and hydrocortisone 2.5%. Action taken with mRNA-1273 in response to the event was not applicable as patient received both doses of the vaccine. This case was linked to MOD-2021-058663 (Patient Link).

Other Meds:

Current Illness:

ID: 1566813
Sex: F
Age: 70
State: NH

Vax Date: 03/04/2021
Onset Date: 03/04/2021
Rec V Date: 08/15/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: Red area in arm; Hard area in arm; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Red area in arm) and INDURATION (Hard area in arm) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation. No Medical History information was reported. On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced ERYTHEMA (Red area in arm) and INDURATION (Hard area in arm). At the time of the report, ERYTHEMA (Red area in arm) and INDURATION (Hard area in arm) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No Concomitant Medication were provided. No Treatment Medications were provided.

Other Meds:

Current Illness:

ID: 1566814
Sex: F
Age: 50
State: IL

Vax Date: 02/20/2021
Onset Date: 02/28/2021
Rec V Date: 08/15/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

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

Symptoms: shortness of breath for about 30 minutes; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (shortness of breath for about 30 minutes) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No medical history was provided by the reporter. On 20-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 DYSPNOEA (shortness of breath for about 30 minutes). On 28-Feb-2021, DYSPNOEA (shortness of breath for about 30 minutes) had resolved. 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: 1566815
Sex: M
Age:
State:

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

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

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

Symptoms: Received a dose of the Moderna COVID19 vaccine from a vial that went through a temperature; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Received a dose of the Moderna COVID19 vaccine from a vial that went through a temperature) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) 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 PRODUCT TEMPERATURE EXCURSION ISSUE (Received a dose of the Moderna COVID19 vaccine from a vial that went through a temperature). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Received a dose of the Moderna COVID19 vaccine from a vial that went through a temperature) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were reported. No treatment medications were provided by the reporter.

Other Meds:

Current Illness:

ID: 1566816
Sex: F
Age:
State: NC

Vax Date: 03/05/2021
Onset Date: 03/05/2021
Rec V Date: 08/15/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Pyrexia, White blood cell count decreased

Symptoms: Increased Heart rates; A spontaneous report was received from a consumer (patient) concerning a 43-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced increased heart rate. The patient's medical history was not provided. No relevant concomitant medications were reported. On 5 Mar 2021, 14 hours prior to the onset of the events the patient received second of two planned doses of mRNA-1273 (batch: 032M20A) Intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 5 Mar 2021, experienced increased heart rate. Her baseline heart rate is usually 60-80 bpm, it went up 120-130 bpm. On 9 Mar 2021, she went to an urgent care. On the same day, electrocardiogram (EKG) was normal. On 15 Mar 2021, the patient followed-up with her doctor and was asked to get some lab work done which she planned to do on 16 Mar 2021. No treatment information was provided. The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable. The outcome of event of increased heart rate was unknown. The reporter did not provide assessment for the event of increased heart rate.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1566817
Sex: M
Age: 54
State: GA

Vax Date: 03/09/2021
Onset Date: 03/01/2021
Rec V Date: 08/15/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Pharyngeal swelling

Symptoms: red splotchy rash; CHILLS; soreness at the injection site; body aches or feeling horrible; joint aches or feeling horrible; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (red splotchy rash), CHILLS (CHILLS), VACCINATION SITE PAIN (soreness at the injection site), MYALGIA (body aches or feeling horrible) and ARTHRALGIA (joint aches or feeling horrible) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030LZOA?) for COVID-19 vaccination. Co-suspect product included non-company product IBUPROFEN for Symptomatic treatment. No medical history reported by the reporter. Concomitant products included METOPROLOL SUCCINATE for an unknown indication. On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started IBUPROFEN (unknown route) 1 dosage form(s). On 10-Mar-2021, the patient experienced RASH ERYTHEMATOUS (red splotchy rash). In March 2021, the patient experienced CHILLS (CHILLS), VACCINATION SITE PAIN (soreness at the injection site), MYALGIA (body aches or feeling horrible) and ARTHRALGIA (joint aches or feeling horrible). At the time of the report, RASH ERYTHEMATOUS (red splotchy rash), CHILLS (CHILLS), VACCINATION SITE PAIN (soreness at the injection site), MYALGIA (body aches or feeling horrible) and ARTHRALGIA (joint aches or feeling horrible) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Reporter did not allow further contact

Other Meds: METOPROLOL SUCCINATE; IBUPROFEN

Current Illness:

ID: 1566818
Sex: F
Age: 68
State: CA

Vax Date: 01/27/2021
Onset Date: 02/24/2021
Rec V Date: 08/15/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Abdominal pain, Chills, Sleep disorder

Symptoms: Enflamed her fibromyalgia; Injection site pain; Aversion to light; Excruciating muscle pain from head to toe; Joints were really bad; Ended up in bed for three days; This spontaneous case was reported by a consumer and describes the occurrence of FIBROMYALGIA (Enflamed her fibromyalgia), PHOTOPHOBIA (Aversion to light), BEDRIDDEN (Ended up in bed for three days), MYALGIA (Excruciating muscle pain from head to toe) and ARTHRALGIA (Joints were really bad) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010AZIA and 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Fibromyalgia. On 27-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 24-Feb-2021, the patient experienced PHOTOPHOBIA (Aversion to light), MYALGIA (Excruciating muscle pain from head to toe) and ARTHRALGIA (Joints were really bad). On an unknown date, the patient experienced FIBROMYALGIA (Enflamed her fibromyalgia), BEDRIDDEN (Ended up in bed for three days) and VACCINATION SITE PAIN (Injection site pain). The patient was treated with CELECOXIB (CELEBREX) at an unspecified dose and frequency. At the time of the report, FIBROMYALGIA (Enflamed her fibromyalgia) and ARTHRALGIA (Joints were really bad) was resolving, PHOTOPHOBIA (Aversion to light) and VACCINATION SITE PAIN (Injection site pain) outcome was unknown and BEDRIDDEN (Ended up in bed for three days) and MYALGIA (Excruciating muscle pain from head to toe) had resolved. No concomitant medications were provided.

Other Meds:

Current Illness: Fibromyalgia

ID: 1566819
Sex: F
Age: 25
State: AZ

Vax Date: 02/13/2021
Onset Date: 02/14/2021
Rec V Date: 08/15/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Diarrhoea, Nasal congestion

Symptoms: pregnant; the most gnarly bruise, started at the injection site, it was really large, dark and purple; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of CONTUSION (the most gnarly bruise, started at the injection site, it was really large, dark and purple) and EXPOSURE DURING PREGNANCY (pregnant) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination. The patient's past medical history included Fertilization (Genetically normal embryo prior to transfer for IVF). Previously administered products included for In vitro fertilization: Estrogen from 04-Sep-2020 to 20-Nov-2020 and Progesterone since 04-Sep-2020. Concomitant products included LEVOTHYROXINE and MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication. On 13-Feb-2021 at 3:55 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 29-May-2021. On 14-Feb-2021, the patient experienced CONTUSION (the most gnarly bruise, started at the injection site, it was really large, dark and purple). On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (pregnant). On 05-Mar-2021, CONTUSION (the most gnarly bruise, started at the injection site, it was really large, dark and purple) had resolved. At the time of the report, EXPOSURE DURING PREGNANCY (pregnant) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Sep-2020, Pregnancy test: positive (Positive) Positive. On 28-Oct-2020, Ultrasound scan: (normal) Patient's ultrasound results were normal.. On 04-Mar-2021, Gestational diabetes: (Negative) Patient's gestational diabetes results were negative.. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. The patient was tested positive for pregnancy on 14-Sep-2020 and estimated date of conception was 10-Sep-2020. Patient had two anatomy scans on 06-Jan2021 and 20-Jan-2021, results were not reported and scheduled for another scan on 01-Apr-2021. No treatment information was reported.

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

Current Illness:

ID: 1566820
Sex: F
Age: 62
State: WA

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

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

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

Symptoms: Soreness of the arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness of the arm) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 03A21A) 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 PAIN IN EXTREMITY (Soreness of the arm). At the time of the report, PAIN IN EXTREMITY (Soreness of the arm) outcome was unknown. Not Provided 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: 1566821
Sex: F
Age: 65
State: MN

Vax Date: 03/12/2021
Onset Date: 03/13/2021
Rec V Date: 08/15/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Rash, Urticaria

Symptoms: Injection site, hot to touch; Swelling at the injection site; Blotchy red near the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Injection site, hot to touch), VACCINATION SITE SWELLING (Swelling at the injection site) and VACCINATION SITE ERYTHEMA (Blotchy red near the injection site) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 immunisation. 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 13-Mar-2021, the patient experienced VACCINATION SITE WARMTH (Injection site, hot to touch). 13-Mar-2021, the patient experienced VACCINATION SITE SWELLING (Swelling at the injection site) and VACCINATION SITE ERYTHEMA (Blotchy red near the injection site). The patient was treated with NAPROXEN at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (Injection site, hot to touch), VACCINATION SITE SWELLING (Swelling at the injection site) and VACCINATION SITE ERYTHEMA (Blotchy red near the injection site) outcome was unknown. Concomitant medications was not reported. Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: Follow-up information received contains non-significant information

Other Meds:

Current Illness:

ID: 1566822
Sex: F
Age: 65
State: NM

Vax Date: 03/10/2021
Onset Date:
Rec V Date: 08/15/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

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

Symptoms: sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination. No Medical History information was reported. On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications were not provided. Treatment information was not provided.

Other Meds:

Current Illness:

ID: 1566823
Sex: F
Age: 50
State: DC

Vax Date: 03/07/2021
Onset Date: 03/07/2021
Rec V Date: 08/15/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

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

Symptoms: Severe persistent arm pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Severe persistent arm pain) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 07-Mar-2021 at 2:00 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Mar-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (Severe persistent arm pain). The patient was treated with PARACETAMOL (TYLENOL) for Pain in arm, at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) for Pain in arm, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Severe persistent arm pain) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No relevant concomitant medications were reported.

Other Meds:

Current Illness:

ID: 1566824
Sex: M
Age: 52
State: PA

Vax Date: 03/09/2021
Onset Date: 03/09/2021
Rec V Date: 08/15/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

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

Symptoms: he felt his face warm; his face was red; he thinks he had allergic reaction; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (he felt his face warm), ERYTHEMA (his face was red) and HYPERSENSITIVITY (he thinks he had allergic reaction) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination. No relevant medical history was reported. Concomitant products included PRAVASTATIN, METFORMIN and ACETYLSALICYLIC ACID (ASPIRIN) for an unknown indication. On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced FEELING HOT (he felt his face warm). 09-Mar-2021, the patient experienced ERYTHEMA (his face was red) and HYPERSENSITIVITY (he thinks he had allergic reaction). On 09-Mar-2021, FEELING HOT (he felt his face warm), ERYTHEMA (his face was red) and HYPERSENSITIVITY (he thinks he had allergic reaction) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Mar-2021, Heart rate: 75-185 (Inconclusive) 75-185. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. The patient also reported his "RPM from 75 to 185.... he felt okay all the time." No treatment medications provided by the reporter. This case was linked to US-MODERNATX, INC.-MOD-2021-046377 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: the patient stated he took 2nd dose of Moderna and he felt fine with no issues. Denied additional follow-up; Sender's Comments: US-MODERNATX, INC.-MOD-2021-046377:Husband case

Other Meds: PRAVASTATIN; METFORMIN; BABY ASPIRIN

Current Illness:

ID: 1566825
Sex: F
Age: 80
State: WI

Vax Date: 01/18/2021
Onset Date: 03/15/2021
Rec V Date: 08/15/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

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

Symptoms: Patient got 3rd dose of vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXTRA DOSE ADMINISTERED (Patient got 3rd dose of vaccine) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012a21a, 011m20a and 037k20a) for COVID-19 vaccination. No medical history was provided by the reporter. On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Mar-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Mar-2021, the patient experienced EXTRA DOSE ADMINISTERED (Patient got 3rd dose of vaccine). On 15-Mar-2021, EXTRA DOSE ADMINISTERED (Patient got 3rd dose of vaccine) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. This case was linked to MOD-2021-044862, MOD-2021-044851 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 06-Apr-2021: Non significant follow up received on 06-APR-2021, no new information

Other Meds:

Current Illness:

ID: 1566826
Sex: F
Age:
State:

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

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: SARS-CoV-2 antibody test, SARS-CoV-2 test negative

Symptoms: hurting arthritis pain; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRITIS (hurting arthritis pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Arthritis. Concomitant products included PREDNISONE for an unknown indication. 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 ARTHRITIS (hurting arthritis pain). The patient was treated with ACETYLSALICYLIC ACID for Adverse event, at an unspecified dose and frequency. At the time of the report, ARTHRITIS (hurting arthritis pain) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.

Other Meds: PREDNISONE

Current Illness: Arthritis

ID: 1566827
Sex: M
Age: 64
State: MI

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

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Ear pain, Hypoaesthesia

Symptoms: surgery due to infection; Injection site shoulder pain; headache; This spontaneous case was reported by a consumer and describes the occurrence of INFECTION (surgery due to infection), VACCINATION SITE PAIN (Injection site shoulder pain) and HEADACHE (headache) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. Concomitant products included FENTANYL, HYDROCODONE, PROMETHAZINE, MOMETASONE FUROATE (NASONEX), FLUTICASONE, SODIUM PROPIONATE (PROPIONATE), INSULIN, TRAVOPROST, DIAZEPAM, VITAMIN C [ASCORBIC ACID], METFORMIN, PREDNISONE, ACETYLSALICYLIC ACID (BABY ASPIRIN), HYDROCHLOROTHIAZIDE, MIRABEGRON (MYRBETRIQ), ATORVASTATIN, LISINOPRIL, VITAMIN D [VITAMIN D NOS], MULTIVITAMIN [VITAMINS NOS], MAGNESIUM, Co-Q10, SITAGLIPTIN PHOSPHATE (JANUVIA [SITAGLIPTIN PHOSPHATE]) and CURCUMA LONGA (TURMERIC [CURCUMA LONGA]) for an unknown indication. On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced VACCINATION SITE PAIN (Injection site shoulder pain) and HEADACHE (headache). On an unknown date, the patient experienced INFECTION (surgery due to infection). At the time of the report, INFECTION (surgery due to infection), VACCINATION SITE PAIN (Injection site shoulder pain) and HEADACHE (headache) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medication also included PreserVision Areds 2 Eye Vitamin Mineral No information about treatment was given.

Other Meds: FENTANYL; HYDROCODONE; PROMETHAZINE; NASONEX; FLUTICASONE; PROPIONATE; INSULIN; TRAVOPROST; DIAZEPAM; VITAMIN C [ASCORBIC ACID]; METFORMIN; PREDNISONE; BABY ASPIRIN; HYDROCHLOROTHIAZIDE; MYRBETRIQ; ATORVASTATIN; LISINOPRIL; VITAMIN D [VITAM

Current Illness:

ID: 1566828
Sex: F
Age: 75
State: OR

Vax Date: 03/11/2021
Onset Date: 03/12/2021
Rec V Date: 08/15/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Abdominal pain upper, Dizziness, Dysgeusia

Symptoms: severe diaaherra; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (severe diaaherra) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination. Concurrent medical conditions included Asthma, COPD and Hypertension. On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DIARRHOEA (severe diaaherra). The patient was treated with LOPERAMIDE HYDROCHLORIDE (LOMOTIL [LOPERAMIDE HYDROCHLORIDE]) for Diarrhoea, at an unspecified dose and frequency. At the time of the report, DIARRHOEA (severe diaaherra) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications reported were asthma medication, chronic obstructive pulmonary disease medication, and blood pressure medication.

Other Meds:

Current Illness: Asthma; COPD; Hypertension

ID: 1566829
Sex: U
Age:
State: TX

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

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Blood pressure increased, Chest discomfort, Heart rate increased

Symptoms: Patient received her first vaccine on January 16th; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient received her first vaccine on January 16th) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included No adverse event (No medical history reported.). On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient received her first vaccine on January 16th). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Patient received her first vaccine on January 16th) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.; Reporter's Comments: This report refers to a case of missed dose for mRNA-1273, lot # unknown with no associated AEs.

Other Meds:

Current Illness:

ID: 1566830
Sex: F
Age:
State: TX

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

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

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

Symptoms: wound up with COVID 19; Missed the 2nd shot; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (wound up with COVID 19) and PRODUCT DOSE OMISSION ISSUE (Missed the 2nd shot) 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-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 COVID-19 (wound up with COVID 19) and PRODUCT DOSE OMISSION ISSUE (Missed the 2nd shot). At the time of the report, COVID-19 (wound up with COVID 19) and PRODUCT DOSE OMISSION ISSUE (Missed the 2nd shot) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test: positive (Positive) Positive for COVID 19 on an Unknown date. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product information was not provided. Treatment information was unknown.

Other Meds:

Current Illness:

ID: 1566831
Sex: M
Age: 68
State: NM

Vax Date: 03/10/2021
Onset Date: 03/11/2021
Rec V Date: 08/15/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Unevaluable event

Symptoms: Chest feels like its draining; Shakes that lasted 3-4 hours; Muscle soreness; Tired; Headache; Fever of 103? F; Uncontrollable chills; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CHEST DISCOMFORT (Chest feels like its draining), TREMOR (Shakes that lasted 3-4 hours), MYALGIA (Muscle soreness), FATIGUE (Tired) and HEADACHE (Headache) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) 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 11-Mar-2021, the patient experienced TREMOR (Shakes that lasted 3-4 hours), MYALGIA (Muscle soreness), FATIGUE (Tired), HEADACHE (Headache), PYREXIA (Fever of 103? F) and CHILLS (Uncontrollable chills). On 15-Mar-2021, the patient experienced CHEST DISCOMFORT (Chest feels like its draining). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 11-Mar-2021, TREMOR (Shakes that lasted 3-4 hours) and CHILLS (Uncontrollable chills) had resolved. At the time of the report, CHEST DISCOMFORT (Chest feels like its draining), MYALGIA (Muscle soreness), FATIGUE (Tired), HEADACHE (Headache) and PYREXIA (Fever of 103? F) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Mar-2021, Body temperature: 103? f, (High) 103? F. On 12-Mar-2021, Body temperature: 102? f. (High) 102? F.. On 13-Mar-2021, Body temperature: 101-102? f. (High) 101-102? F.. On 14-Mar-2021, Body temperature: normal (normal) Normal. 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 06-May-2021: Follow up was received on 06-MAY-20221. All reported events outcome was updated to recovered/resolved.

Other Meds:

Current Illness:

ID: 1566832
Sex: F
Age: 59
State: FL

Vax Date: 03/05/2021
Onset Date: 03/05/2021
Rec V Date: 08/15/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

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

Symptoms: sore arm; (lump in arm) that is very red and raised; (lump in arm) that is very red; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), VACCINATION SITE MASS ((lump in arm) that is very red and raised) and ERYTHEMA ((lump in arm) that is very red) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination. Concurrent medical conditions included Blood pressure. Concomitant products included IRON, VITAMIN D NOS, CURCUMIN (TURMERIC MERIVA), HYDROCODONE, CINNAMON [CINNAMOMUM VERUM], GABAPENTIN and ACETIC ACID (SUMMERS EVE VINEGAR - WATER) for an unknown indication. On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm), VACCINATION SITE MASS ((lump in arm) that is very red and raised) and ERYTHEMA ((lump in arm) that is very red). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (sore arm), VACCINATION SITE MASS ((lump in arm) that is very red and raised) and ERYTHEMA ((lump in arm) that is very red) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medication included blood pressure medicine

Other Meds: IRON; VITAMIN D NOS; TURMERIC MERIVA; HYDROCODONE; CINNAMON [CINNAMOMUM VERUM]; GABAPENTIN; SUMMERS EVE VINEGAR - WATER

Current Illness: Blood pressure

ID: 1566833
Sex: M
Age: 54
State: OK

Vax Date: 03/10/2021
Onset Date: 03/10/2021
Rec V Date: 08/15/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Injection site pain, Pain

Symptoms: tongue feel like it was burnt with coffee; soreness in arm of injection site; This spontaneous case was reported by a consumer and describes the occurrence of TONGUE DISCOMFORT (tongue feel like it was burnt with coffee) and VACCINATION SITE PAIN (soreness in arm of injection site) in a 55-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 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 PAIN (soreness in arm of injection site). On 12-Mar-2021, the patient experienced TONGUE DISCOMFORT (tongue feel like it was burnt with coffee). On 12-Mar-2021, VACCINATION SITE PAIN (soreness in arm of injection site) had resolved. On 18-Mar-2021, TONGUE DISCOMFORT (tongue feel like it was burnt with coffee) had resolved. 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. Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: Follow up received on 06-May-2021. Outcome of event updated.

Other Meds:

Current Illness:

ID: 1566834
Sex: M
Age: 43
State: TX

Vax Date: 03/09/2021
Onset Date: 03/15/2021
Rec V Date: 08/15/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Injection site pain, Menorrhagia

Symptoms: This spontaneous case was reported by a consumer and describes the occurrence of CHILLS, MYALGIA in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination. No Medical History information was reported. On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced CHILLS, MYALGIA and LYMPHADENOPATHY. At the time of the report, CHILLS, MYALGIA and LYMPHADENOPATHY outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were provided by the reporter. Treatment of the events included an unspecified anti-inflammatory.

Other Meds:

Current Illness:

ID: 1566835
Sex: F
Age: 80
State: ME

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

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

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

Symptoms: unrelenting and cannot focus; arm is still tender; arm feels a little swollen; aches, pains (Muscle pain specifically); fatigue; continues to feel extremely fatigued, exhausted and she cannot stop napping; This spontaneous case was reported by a consumer and describes the occurrence of DISTURBANCE IN ATTENTION (unrelenting and cannot focus), TENDERNESS (arm is still tender), PERIPHERAL SWELLING (arm feels a little swollen), MYALGIA (aches, pains (Muscle pain specifically)) and FATIGUE (fatigue; continues to feel extremely fatigued, exhausted and she cannot stop napping) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination. Concurrent medical conditions included Insect sting allergy. On 25-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DISTURBANCE IN ATTENTION (unrelenting and cannot focus), TENDERNESS (arm is still tender), PERIPHERAL SWELLING (arm feels a little swollen), MYALGIA (aches, pains (Muscle pain specifically)) and FATIGUE (fatigue; continues to feel extremely fatigued, exhausted and she cannot stop napping). At the time of the report, DISTURBANCE IN ATTENTION (unrelenting and cannot focus) and MYALGIA (aches, pains (Muscle pain specifically)) outcome was unknown and TENDERNESS (arm is still tender), PERIPHERAL SWELLING (arm feels a little swollen) and FATIGUE (fatigue; continues to feel extremely fatigued, exhausted and she cannot stop napping) had not resolved. No relevant concomitant medications were reported. Treatment details included aspirin and diphenhydramine.

Other Meds:

Current Illness: Insect sting allergy

ID: 1566836
Sex: F
Age:
State:

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

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Nausea, Pain in extremity, Pyrexia

Symptoms: COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in an 82-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, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test positive: positive (Positive) Positive for COVID. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No relevant concomitant medications were reported. No treatment information was provided. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1566837
Sex: F
Age: 63
State: NY

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

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: This spontaneous case was reported by a consumer and describes the occurrence of EYE IRRITATION (Eyes burning), FEELING ABNORMAL (Felt like she had been run over by a Mack truck), HYPERHIDROSIS (Sweating), INFLUENZA LIKE ILLNESS (Flu-like symptoms) and HEADACHE (Headache) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced EYE IRRITATION (Eyes burning), FEELING ABNORMAL (Felt like she had been run over by a Mack truck), HYPERHIDROSIS (Sweating), INFLUENZA LIKE ILLNESS (Flu-like symptoms), HEADACHE (Headache), VACCINATION SITE PAIN (Sore arm), FATIGUE (Very exhausted) and CHILLS (Chills). At the time of the report, EYE IRRITATION (Eyes burning), FEELING ABNORMAL (Felt like she had been run over by a Mack truck), HYPERHIDROSIS (Sweating), INFLUENZA LIKE ILLNESS (Flu-like symptoms), HEADACHE (Headache), VACCINATION SITE PAIN (Sore arm), FATIGUE (Very exhausted) and CHILLS (Chills) 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: 1566838
Sex: F
Age: 76
State: CA

Vax Date: 02/16/2021
Onset Date: 02/23/2021
Rec V Date: 08/15/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

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

Symptoms: very sore along her upper left torso, soreness was in the front and back; started to develop a red rash and blisters, blisters are scabbed over good, diagnosed with shingles; red, itchy, and sore circle which was about 6 inches around the injection site.; red, itchy, and sore circle which was about 6 inches around the injection site.; red, itchy, and sore circle which was about 6 inches around the injection site.; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (very sore along her upper left torso, soreness was in the front and back; started to develop a red rash and blisters, blisters are scabbed over good, diagnosed with shingles), VACCINATION SITE PRURITUS (red, itchy, and sore circle which was about 6 inches around the injection site.), VACCINATION SITE ERYTHEMA (red, itchy, and sore circle which was about 6 inches around the injection site.) and VACCINATION SITE PAIN (red, itchy, and sore circle which was about 6 inches around the injection site.) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination. The patient's past medical history included Mastectomy. On 16-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 VACCINATION SITE PRURITUS (red, itchy, and sore circle which was about 6 inches around the injection site.), VACCINATION SITE ERYTHEMA (red, itchy, and sore circle which was about 6 inches around the injection site.) and VACCINATION SITE PAIN (red, itchy, and sore circle which was about 6 inches around the injection site.). On 10-Mar-2021, the patient experienced HERPES ZOSTER (very sore along her upper left torso, soreness was in the front and back; started to develop a red rash and blisters, blisters are scabbed over good, diagnosed with shingles). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and VALACICLOVIR HYDROCHLORIDE (VALTREX) at an unspecified dose and frequency. On 24-Feb-2021, VACCINATION SITE PRURITUS (red, itchy, and sore circle which was about 6 inches around the injection site.) had resolved. On 27-Feb-2021, VACCINATION SITE ERYTHEMA (red, itchy, and sore circle which was about 6 inches around the injection site.) and VACCINATION SITE PAIN (red, itchy, and sore circle which was about 6 inches around the injection site.) had resolved. At the time of the report, HERPES ZOSTER (very sore along her upper left torso, soreness was in the front and back; started to develop a red rash and blisters, blisters are scabbed over good, diagnosed with shingles) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No relevant concomitant medications were reported.

Other Meds:

Current Illness:

ID: 1566839
Sex: F
Age:
State: NJ

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

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Nausea

Symptoms: itchiness; soreness on her arm; hives on her leg and back like mosquito bites; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PRURITUS (itchiness), PAIN IN EXTREMITY (soreness on her arm) and URTICARIA (hives on her leg and back like mosquito bites) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012a21a) for COVID-19 vaccination. No Medical History information was reported. On 12-Mar-2021 at 10:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced PRURITUS (itchiness), PAIN IN EXTREMITY (soreness on her arm) and URTICARIA (hives on her leg and back like mosquito bites). On 13-Mar-2021, PRURITUS (itchiness), PAIN IN EXTREMITY (soreness on her arm) and URTICARIA (hives on her leg and back like mosquito bites) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications were not provided by the reporter. Treatment for the events included oral diphenhydramine, hydrocortisone cream, and calamine cream. Her physician stated that she should not take the 2nd vaccine dose.

Other Meds:

Current Illness:

ID: 1566840
Sex: F
Age: 83
State: MI

Vax Date: 02/04/2021
Onset Date: 03/01/2021
Rec V Date: 08/15/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Injection site pain

Symptoms: Little bumps in cheek area, on the back, thigh area, across the shoulder; Rash that she developed 4 to 5 days after getting 2nd dose of vaccine; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Little bumps in cheek area, on the back, thigh area, across the shoulder) and RASH (Rash that she developed 4 to 5 days after getting 2nd dose of vaccine) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Seizure. On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In March 2021, the patient experienced SWELLING (Little bumps in cheek area, on the back, thigh area, across the shoulder) and RASH (Rash that she developed 4 to 5 days after getting 2nd dose of vaccine). At the time of the report, SWELLING (Little bumps in cheek area, on the back, thigh area, across the shoulder) and RASH (Rash that she developed 4 to 5 days after getting 2nd dose of vaccine) had not resolved. Concomitant medication include seizure medication. Treatment information was not provided. This case was linked to MOD-2021-213779 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 15-Mar-2021: Follow-up received and does not contain any new information.

Other Meds:

Current Illness: Seizure

ID: 1566841
Sex: F
Age:
State:

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

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

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

Symptoms: weak; tired; This spontaneous case was reported by a patient and describes the occurrence of ASTHENIA (weak) and FATIGUE (tired) 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 11-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 ASTHENIA (weak) and FATIGUE (tired). At the time of the report, ASTHENIA (weak) and FATIGUE (tired) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant and treatment medications were reported.

Other Meds:

Current Illness:

ID: 1566842
Sex: F
Age: 74
State: FL

Vax Date: 03/04/2021
Onset Date: 03/15/2021
Rec V Date: 08/15/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

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

Symptoms: Sore arm; Warm to touch at the injection site; Hardness at the injection site; Redness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), VACCINATION SITE WARMTH (Warm to touch at the injection site), VACCINATION SITE INDURATION (Hardness at the injection site) and VACCINATION SITE ERYTHEMA (Redness at the injection site) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination. Concurrent medical conditions included Osteoporosis, Sjogren's syndrome, Anxiety and Neuropathy. On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), VACCINATION SITE WARMTH (Warm to touch at the injection site), VACCINATION SITE INDURATION (Hardness at the injection site) and VACCINATION SITE ERYTHEMA (Redness at the injection site). At the time of the report, PAIN IN EXTREMITY (Sore arm), VACCINATION SITE WARMTH (Warm to touch at the injection site), VACCINATION SITE INDURATION (Hardness at the injection site) and VACCINATION SITE ERYTHEMA (Redness at the injection site) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. The patient reported taking concomitant medications to treat osteoporosis, Sjogren Syndrome, anxiety, and neuropathy (unspecified). Treatment information was not provided.

Other Meds:

Current Illness: Anxiety; Neuropathy; Osteoporosis; Sjogren's syndrome

ID: 1566843
Sex: F
Age: 76
State: PA

Vax Date: 03/11/2021
Onset Date: 03/12/2021
Rec V Date: 08/15/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Tremor

Symptoms: Dizziness; headache; Body Pain/body aches; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), HEADACHE (headache) and MYALGIA (Body Pain/body aches) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. No Medical History information was reported. On 11-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 DIZZINESS (Dizziness), HEADACHE (headache) and MYALGIA (Body Pain/body aches). At the time of the report, DIZZINESS (Dizziness), HEADACHE (headache) and MYALGIA (Body Pain/body aches) 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: 1566844
Sex: M
Age: 58
State: WA

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

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Erythema, Pruritus

Symptoms: Due to scheduling issues, he missed the second dose; A spontaneous report was received from a consumer concerning a 58-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and due to scheduling issues, he missed the second dose/ product dose omission issue. The patient's medical history was not provided. No relevant concomitant medications were reported. On 27-Jan-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch Number: 007M20A) for prophylaxis of COVID-19 infection. On an unspecified date, due to scheduling issues, the patient missed the second dose. The patient was more than 42 days post first dose and was not able to get the second dose. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the event, due to scheduling issues, he missed the second dose was considered resolved.; Sender's Comments: This report refers to a case of Missed Dose for mRNA-1273, lot #unknown with no associated AEs.

Other Meds:

Current Illness:

ID: 1566845
Sex: M
Age:
State: IN

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

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling, Myalgia

Symptoms: Messed up sinuses; Muscle ache; Chills; Fever; Flu like symptoms; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of SINUSITIS (Messed up sinuses), INFLUENZA LIKE ILLNESS (Flu like symptoms), PAIN IN EXTREMITY (Sore arm), MYALGIA (Muscle ache) and CHILLS (Chills) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 11-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 12-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms). On 13-Mar-2021, the patient experienced SINUSITIS (Messed up sinuses), MYALGIA (Muscle ache), CHILLS (Chills) and PYREXIA (Fever ). At the time of the report, SINUSITIS (Messed up sinuses), INFLUENZA LIKE ILLNESS (Flu like symptoms), PAIN IN EXTREMITY (Sore arm), MYALGIA (Muscle ache), CHILLS (Chills) and PYREXIA (Fever ) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Mar-2021, Body temperature: 101.2 (High) fever of 101.2. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. The concomitant medications were not listed. The treatment information was not provided. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1566846
Sex: M
Age: 65
State: MD

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

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

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

Symptoms: left calve and foot swelled up; lower back pain between kidneys; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (left calve and foot swelled up) and BACK PAIN (lower back pain between kidneys) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013K21A) 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) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced PERIPHERAL SWELLING (left calve and foot swelled up) and BACK PAIN (lower back pain between kidneys). On 08-Mar-2021, PERIPHERAL SWELLING (left calve and foot swelled up) and BACK PAIN (lower back pain between kidneys) had resolved. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No relevant concomitant medications were reported. No treatment information was provided.

Other Meds:

Current Illness:

ID: 1566847
Sex: F
Age: 84
State: FL

Vax Date: 02/19/2021
Onset Date: 03/07/2021
Rec V Date: 08/15/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Asthenia, Chills, Headache, Myalgia

Symptoms: Couldn't smell the Vapor Rub; I am very nasally and it's all up in my head; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of NASAL DISORDER (I am very nasally and it's all up in my head) and ANOSMIA (Couldn't smell the Vapor Rub) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Mar-2021, the patient experienced NASAL DISORDER (I am very nasally and it's all up in my head). On 09-Mar-2021, the patient experienced ANOSMIA (Couldn't smell the Vapor Rub). At the time of the report, NASAL DISORDER (I am very nasally and it's all up in my head) and ANOSMIA (Couldn't smell the Vapor Rub) outcome was unknown. Treatment medications included Z-pack and Vapor Rub

Other Meds:

Current Illness:

ID: 1566848
Sex: M
Age:
State: AL

Vax Date: 12/30/2020
Onset Date: 12/30/2020
Rec V Date: 08/15/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

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

Symptoms: Flu-like symptoms; Bad headache; fever; Chills; This spontaneous case was reported by an other health care professional and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu-like symptoms), HEADACHE (Bad headache), PYREXIA (fever) and CHILLS (Chills) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On 30-Dec-2020, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like symptoms), HEADACHE (Bad headache), PYREXIA (fever) and CHILLS (Chills). At the time of the report, INFLUENZA LIKE ILLNESS (Flu-like symptoms), HEADACHE (Bad headache), PYREXIA (fever) and CHILLS (Chills) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Pyrexia: 99-100 f 99-100 F. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication and treatment information was provided. Action taken with mRNA-1273 in response to the events was not applicable. This case was linked to MOD-2021-024861 (Patient Link).

Other Meds:

Current Illness:

ID: 1566849
Sex: F
Age: 91
State: CA

Vax Date: 01/29/2021
Onset Date: 03/14/2021
Rec V Date: 08/15/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

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

Symptoms: This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Woke up in the middle of the night and felt dizzy) in a 91-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A and 042L20A) for COVID-19 vaccination. Concurrent medical conditions included Blood pressure high. On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Mar-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DIZZINESS (Woke up in the middle of the night and felt dizzy). On 14-Mar-2021, DIZZINESS (Woke up in the middle of the night and felt dizzy) had resolved. Concomitant medications included unspecified high blood pressure medication. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not Applicable. This case was linked to MOD-2021-058186 (Patient Link).

Other Meds:

Current Illness: Blood pressure high

ID: 1566850
Sex: F
Age:
State: NY

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

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Pain in extremity

Symptoms: A redness around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (A redness around the injection site) in an 86-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 06-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (A redness around the injection site). The patient was treated with LORATADINE (CLARITIN [LORATADINE]) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE ERYTHEMA (A redness around the injection site) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. The reporter was calling on behalf of their mother who received the vaccine 2 weeks ago and developed a redness around the injection site. Reportedly, on 15-Mar-2021, it became larger. No Concomitant product use was reported.

Other Meds:

Current Illness:

ID: 1566851
Sex: M
Age:
State: MS

Vax Date: 01/18/2021
Onset Date: 01/18/2021
Rec V Date: 08/15/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Abdominal pain upper, Abnormal behaviour, Adverse reaction, Anger, Asthma

Symptoms: Past the 42 days and has not received second dose; Back pain; Muscle spasms in back; Back knots; A spontaneous report was received from a consumer concerning a male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced, back pain, muscle spasms in back, back knots and past the 42 days had not received second dose. The patient's medical history was not provided. No relevant concomitant medications were provided. On 18 Jan 2021, prior to the onset of events, the patient received their first of the two planned doses of mRNA-1273 (lot/batch: unknown) via unknown route for prophylaxis of COVID-19 infection. On 18 Jan 2021, on the day of vaccination, the patient developed back pain and muscle spasm in back and back knots for three weeks. In addition, the patient had not received his second dose yet and was past the 42 days for receiving it. No Laboratory investigations were provided. No Treatment information was provided. Action taken with mRNA-1273 in response to the events was not applicable. The outcomes of the events, back pain, muscle spasms in back and back knots, were resolved.; Reporter's Comments: This report refers to a case of Inappropriate schedule of product administration for mRNA-1273. Based on the current available information and temporal association between the use of the product and the start date of the events (back pain, muscle spasms in back, and back knots), a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1566852
Sex: M
Age: 72
State: FL

Vax Date: 01/30/2021
Onset Date: 03/01/2021
Rec V Date: 08/15/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

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

Symptoms: palpitations; same side effects as it did; COVID; felt like if it was a chicken was being killed; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (palpitations), VACCINATION COMPLICATION (same side effects as it did), COVID-19 (COVID) and FEELING ABNORMAL (felt like if it was a chicken was being killed) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Blood pressure abnormal. On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In March 2021, the patient experienced PALPITATIONS (palpitations), VACCINATION COMPLICATION (same side effects as it did), COVID-19 (COVID) and FEELING ABNORMAL (felt like if it was a chicken was being killed). At the time of the report, PALPITATIONS (palpitations), VACCINATION COMPLICATION (same side effects as it did), COVID-19 (COVID) and FEELING ABNORMAL (felt like if it was a chicken was being killed) outcome was unknown. Concomitant medications included unspecified blood pressure pills. No treatment information was provided.

Other Meds:

Current Illness: Blood pressure abnormal

ID: 1566853
Sex: M
Age:
State: PR

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

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

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

Symptoms: received a dose of the Moderna COVID19 vaccine from a vial that went through a temperature excursion; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (received a dose of the Moderna COVID19 vaccine from a vial that went through a temperature excursion) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) 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 PRODUCT STORAGE ERROR (received a dose of the Moderna COVID19 vaccine from a vial that went through a temperature excursion). At the time of the report, PRODUCT STORAGE ERROR (received a dose of the Moderna COVID19 vaccine from a vial that went through a temperature excursion) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications reported . No treatment medications provided by the reporter.

Other Meds:

Current Illness:

ID: 1566854
Sex: F
Age: 53
State: CA

Vax Date: 02/18/2021
Onset Date: 02/18/2021
Rec V Date: 08/15/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Vomiting

Symptoms: increased heart rate; Elevated blood pressure up to 177/110; Facial flushing; This spontaneous case was reported by a nurse and describes the occurrence of TACHYCARDIA (increased heart rate), HYPERTENSION (Elevated blood pressure up to 177/110) and FLUSHING (Facial flushing) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 062H20D) for COVID-19 vaccination. Concomitant products included MELATONIN, OXITRIPTAN (5 HTP [OXITRIPTAN]), VITAMINS NOS and LORATADINE (CLARITIN [LORATADINE]) for an unknown indication. On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced TACHYCARDIA (increased heart rate), HYPERTENSION (Elevated blood pressure up to 177/110) and FLUSHING (Facial flushing). On 18-Feb-2021, TACHYCARDIA (increased heart rate) and FLUSHING (Facial flushing) had resolved. On 25-Feb-2021, HYPERTENSION (Elevated blood pressure up to 177/110) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Feb-2021, Blood pressure measurement: 177/110 (High) 177/110. 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: MELATONIN; 5 HTP [OXITRIPTAN]; VITAMINS NOS; CLARITIN [LORATADINE]

Current Illness:

ID: 1566855
Sex: F
Age: 81
State: MA

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

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Headache, Limb discomfort, Nasal congestion

Symptoms: shingles; Sore arm/painful; red dowm to her elbow; hot to touch; swollen; itchy; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (shingles), PAIN IN EXTREMITY (Sore arm/painful), ERYTHEMA (red dowm to her elbow), HYPERAESTHESIA (hot to touch) and PERIPHERAL SWELLING (swollen) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 11-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 an unknown date, the patient experienced HERPES ZOSTER (shingles), PAIN IN EXTREMITY (Sore arm/painful), ERYTHEMA (red dowm to her elbow), HYPERAESTHESIA (hot to touch), PERIPHERAL SWELLING (swollen) and PRURITUS (itchy). At the time of the report, HERPES ZOSTER (shingles), PAIN IN EXTREMITY (Sore arm/painful), ERYTHEMA (red dowm to her elbow), HYPERAESTHESIA (hot to touch), PERIPHERAL SWELLING (swollen) and PRURITUS (itchy) outcome was unknown. No concomitant medication was reported. No treatment medication was reported The patient had been applying cold ice pack to help with the swelling but the itchiness is still bothersome. Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: Updated reporter's address and added one additional event (shingles). On 11-May-2021: Reporter email address was added, patient demographics was added and first dose details of suspect product was updated.

Other Meds:

Current Illness:

ID: 1566856
Sex: F
Age: 61
State: NJ

Vax Date: 03/10/2021
Onset Date: 03/10/2021
Rec V Date: 08/15/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Back pain, Cold sweat, Headache, Nausea, Vomiting

Symptoms: Hypersensitivity reaction; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (Hypersensitivity reaction) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030a21a) for COVID-19 vaccination. Previously administered products included for Shingles: Shingrix (Shingles Vaccine). Past adverse reactions to the above products included No adverse event with Shingrix. Concurrent medical conditions included Asthma since 1996, Hypersensitivity reaction, Allergy to antibiotic (Avelox allergy Facial swelling, lip swelling, eye lid swelling), Overgrowth bacterial since 13-Apr-2013, Hay fever and Hives. Concomitant products included MELATONIN from April 2020 to an unknown date for Sleep problem, VITAMIN D3 from April 2015 to an unknown date for an unknown indication. On 10-Mar-2021 at 12:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HYPERSENSITIVITY (Hypersensitivity reaction). The patient was treated with SALBUTAMOL (nasal) at an unspecified dose and frequency; PARACETAMOL (TYLENOL) at a dose of 1 dosage form and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (oral) from 10-Mar-2021 to 13-Mar-2021 for Hypersensitivity reaction, at a dose of UNK, prn. On 13-Mar-2021, HYPERSENSITIVITY (Hypersensitivity reaction) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Patient had headache and fatigue for 3 or 4 days.Event was recovered on 26-2021. Patient experienced similar events after second dose. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Of note, the patient's medical history of previous hypersensitivity reactions is a confounding factor that may play a possible contributory role. Most recent FOLLOW-UP information incorporated above includes: On 17-Jun-2021: ADR form was received on 17-JUN-2021. Patient's demographics such as race, ethnicity, weight, height was added. Patient's relevant medical history, concomitant medications was updated. Patient was diagnosed with hypersensitivity reaction, so this event was included. Event outcome was updated. It contains significant information.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Of note, the patient's medical history of previous hypersensitivity reactions is a confounding factor that may play a possible contributory role.

Other Meds: MELATONIN; VITAMIN D3

Current Illness: Allergy to antibiotic (Avelox allergy Facial swelling, lip swelling, eye lid swelling); Asthma; Hay fever; Hives; Hypersensitivity reaction; Overgrowth bacterial

ID: 1566857
Sex: F
Age: 54
State: PA

Vax Date: 02/04/2021
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Rec V Date: 08/15/2021
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Symptom List: Injection site swelling, Limb discomfort

Symptoms: Shipment of the 2nd dose to the facility had been delayed; at that point I was beyond the 42 day mark; Shipment of the 2nd dose to the facility had been delayed; at that point I was beyond the 42 day mark; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT AVAILABILITY ISSUE (Shipment of the 2nd dose to the facility had been delayed; at that point I was beyond the 42 day mark) and PRODUCT ADMINISTRATION INTERRUPTED (Shipment of the 2nd dose to the facility had been delayed; at that point I was beyond the 42 day mark) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination. No Medical History information was reported. On 04-Feb-2021 at 11:35 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT AVAILABILITY ISSUE (Shipment of the 2nd dose to the facility had been delayed; at that point I was beyond the 42 day mark) and PRODUCT ADMINISTRATION INTERRUPTED (Shipment of the 2nd dose to the facility had been delayed; at that point I was beyond the 42 day mark). At the time of the report, PRODUCT AVAILABILITY ISSUE (Shipment of the 2nd dose to the facility had been delayed; at that point I was beyond the 42 day mark) and PRODUCT ADMINISTRATION INTERRUPTED (Shipment of the 2nd dose to the facility had been delayed; at that point I was beyond the 42 day mark) had resolved. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing was delayed on an unknown date. Concomitant medications were not provided by the reporter. Treatment information was not reported. Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: The completed Form includes an update to patient's race and additional event details, the patient had not received 2nd dose at the time of the FU report

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Current Illness:

ID: 1566858
Sex: M
Age: 65
State: KY

Vax Date: 03/13/2021
Onset Date: 03/15/2021
Rec V Date: 08/15/2021
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Symptom List: Chills, Diarrhoea, Fatigue, Feeling abnormal, Headache

Symptoms: Dizziness; head feels like its numb; feels like he is in "drunk mode"; Nausea; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DIZZINESS (Dizziness), HYPOAESTHESIA (head feels like its numb), SOMNOLENCE (feels like he is in "drunk mode") and NAUSEA (Nausea) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination. No Medical History information was reported. On 13-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 DIZZINESS (Dizziness), HYPOAESTHESIA (head feels like its numb), SOMNOLENCE (feels like he is in "drunk mode") and NAUSEA (Nausea). At the time of the report, DIZZINESS (Dizziness), HYPOAESTHESIA (head feels like its numb), SOMNOLENCE (feels like he is in "drunk mode") and NAUSEA (Nausea) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No relevant concomitant medications were reported. The patient reached primary care professional (PCP) who advised him to wait for 48 hours for events to subside. No treatment was taken by the patient.

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Current Illness:

ID: 1566859
Sex: F
Age:
State: CA

Vax Date: 02/06/2021
Onset Date: 02/06/2021
Rec V Date: 08/15/2021
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Symptom List: Hot flush, Myalgia, Nausea, Tension headache

Symptoms: This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (arm was sore) and FATIGUE (extremely fatigue) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination. Concurrent medical conditions included Atrial fibrillation. Concomitant products included DILTIAZEM for Atrial fibrillation, APIXABAN (ELIQUIS) for an unknown indication. On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced MYALGIA (arm was sore). On 07-Feb-2021, the patient experienced FATIGUE (extremely fatigue). At the time of the report, MYALGIA (arm was sore) and FATIGUE (extremely fatigue) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessment. Treatment information was not provided. This case was linked to MOD-2021-045433 (Patient Link).

Other Meds: ELIQUIS; DILTIAZEM

Current Illness: Atrial fibrillation

Total 2021 VAERS Injuries: 704,237

Page last modified: 26 October 2021 2:21am