VAERS 2021 Database www.vaers.hhs.gov

Main Page | All 2021 Deaths | Videos
VAERS Updated: 10/01/2021
** VAERS DATABASE Last updated: October 1, 2021**
PLEASE CHECK BACK SOON
Download the files above while you wait.







Manufacturers

Total Manufacturer

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: 1543324
Sex: F
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List: Dysphagia, Epiglottitis

Symptoms: Pregnant patient received second Moderna COVID-19 vaccine; This spontaneous prospective pregnancy case was reported by a health care professional and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant patient received second Moderna COVID-19 vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant patient received second Moderna COVID-19 vaccine). At the time of the report, EXPOSURE DURING PREGNANCY (Pregnant patient received second Moderna COVID-19 vaccine) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication was provided. Patient was pregnant and just received her second dose of the Moderna COVID-19 vaccine. No treatment information was provided.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.

Other Meds:

Current Illness:

ID: 1543325
Sex: F
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List: Anxiety, Dyspnoea

Symptoms: reaction a week later at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (reaction a week later at the injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (reaction a week later at the injection site). At the time of the report, VACCINATION SITE REACTION (reaction a week later at the injection site) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment information was provided. No concomitant medication was provided.

Other Meds:

Current Illness:

ID: 1543326
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/11/2021
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: Pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING DELIVERY (Pregnancy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced MATERNAL EXPOSURE DURING DELIVERY (Pregnancy). At the time of the report, MATERNAL EXPOSURE DURING DELIVERY (Pregnancy) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No treatment information provided by reporter.

Other Meds:

Current Illness:

ID: 1543327
Sex: F
Age: 29
State: MA

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

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

Lab Data:

Allergies:

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: This spontaneous prospective pregnancy case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) in a 29-year-old female patient (gravida 2) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A and 025J20A) for COVID-19 vaccination. The patient's past medical history included Sleep apnea (Stable) in 2015 and Narcolepsy (Stable) in 2015. Concurrent medical conditions included Hypertension since December 2020, Hypothyroidism (Stable) since December 2020, Migraine (Stable) in November 2020 and Heartburn since 2015. Concomitant products included FAMOTIDINE for Heartburn, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for Hypertension, LEVOTHYROXINE for Hypothyroidism, MAGNESIUM OXIDE for Migraine, PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE] for Pregnancy. On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 29-Sep-2020 and the estimated date of delivery was 07-Jul-2021. On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the fourteenth week of the pregnancy. At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Oct-2020, Pregnancy test: positive (Positive) Positive. In January 2021, Ultrasound foetal: inconclusive (Inconclusive) Inconclusive and inconclusive (Inconclusive) Inconclusive. In 2021, Glucose tolerance test: 105 (normal) 105. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No Treatment information was provided. The patient's date of conception was 12-Oct-2020. The patient had a miscarriage on 14-May-2020.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.

Other Meds: ASPIRIN (E.C.); LEVOTHYROXINE; PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS ; MAGNESIUM OXIDE; FAMOTIDINE

Current Illness: Heartburn; Hypertension; Hypothyroidism (Stable)

ID: 1543328
Sex: M
Age: 72
State: OK

Vax Date: 01/18/2021
Onset Date: 01/20/2021
Rec V Date: 08/11/2021
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: felt little pain/pain aching on the whole body; headache; injection site was swollen; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (felt little pain/pain aching on the whole body), HEADACHE (headache) and INJECTION SITE SWELLING (injection site was swollen) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. No Medical History information was reported. On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced PAIN (felt little pain/pain aching on the whole body), HEADACHE (headache) and INJECTION SITE SWELLING (injection site was swollen). At the time of the report, PAIN (felt little pain/pain aching on the whole body), HEADACHE (headache) and INJECTION SITE SWELLING (injection site was swollen) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product use was not provided by the reporter. No treatment information was provided.

Other Meds:

Current Illness:

ID: 1543329
Sex: F
Age: 71
State: MI

Vax Date: 01/13/2021
Onset Date: 01/14/2021
Rec V Date: 08/11/2021
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: Grape sized swelling near the injection Site; Grape sized swelling near the injection Site; Itchy sensation near the injection Site; Itchy sensation near the injection Site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of the first episode of VACCINATION SITE PRURITUS (Itchy sensation near the injection Site), the second episode of VACCINATION SITE PRURITUS (Itchy sensation near the injection Site), the first episode of VACCINATION SITE SWELLING (Grape sized swelling near the injection Site) and the second episode of VACCINATION SITE SWELLING (Grape sized swelling near the injection Site) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination. No Medical History information was reported. On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced the first episode of VACCINATION SITE PRURITUS (Itchy sensation near the injection Site) and the second episode of VACCINATION SITE PRURITUS (Itchy sensation near the injection Site). On 17-Jan-2021, the patient experienced the first episode of VACCINATION SITE SWELLING (Grape sized swelling near the injection Site) and the second episode of VACCINATION SITE SWELLING (Grape sized swelling near the injection Site). At the time of the report, last episode of VACCINATION SITE PRURITUS (Itchy sensation near the injection Site) was resolving and last episode of VACCINATION SITE SWELLING (Grape sized swelling near the injection Site) had not 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. Concomitant product use was not provided by the reporter. No treatment information was provided.

Other Meds:

Current Illness:

ID: 1543330
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/11/2021
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: tested positive; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (tested positive) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (tested positive). At the time of the report, COVID-19 (tested positive) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No treatment information was provided. No concomitant medication was provided.

Other Meds:

Current Illness:

ID: 1543331
Sex: F
Age: 34
State: KS

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

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

Lab Data:

Allergies:

Symptom List: Pharyngeal swelling

Symptoms: Got vaccine during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Got vaccine during pregnancy) in a 34-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination. The patient's past medical history included Pregnancy (Accessory Tragus Live, full-term birth) on 18-Jun-2019 and Alcohol use (1-2 drinks per week) on 01-Nov-2020. Concomitant products included VITAMIN D NOS from 2019 to an unknown date and MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) from 2018 to an unknown date for an unknown indication. On 09-Jan-2021 at 2:30 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 05-Nov-2020 and the estimated date of delivery was 12-Aug-2021. On 09-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Got vaccine during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the ninth week of the pregnancy. On 09-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Got vaccine during pregnancy) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Nov-2020, Pregnancy test: positive (Positive) Positive. 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. Estimated date of conception was on 18-Nov-2020. Number of fetus was found to be one. On ??-???-2012, lab test included genetic predisposition test, however the result included heterozygous for factor 5 Lieden. Concomitant product Vitamin D was used for the indication to help breast milk. Treatment information was not provided.

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

Current Illness:

ID: 1543332
Sex: M
Age: 65
State: FL

Vax Date: 01/15/2021
Onset Date: 01/19/2021
Rec V Date: 08/11/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Abdominal pain, Chills, Sleep disorder

Symptoms: Mild fever 99-100 F; Coughing; Tested positive for covid; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Mild fever 99-100 F) and COUGH (Coughing) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 613L20A) for COVID-19 vaccination. No medical history reported. Concomitant products included ATORVASTATIN for Cholesterol. On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced PYREXIA (Mild fever 99-100 F) and COUGH (Coughing). The patient was treated with ACETAMINOPHEN at an unspecified dose and frequency and OMEPRAZOLE for Reflexes abnormal, at an unspecified dose and frequency. At the time of the report, PYREXIA (Mild fever 99-100 F) and COUGH (Coughing) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Jan-2021, SARS-CoV-2 test: Positive. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2021: NNI

Other Meds: ATORVASTATIN

Current Illness:

ID: 1543333
Sex: F
Age:
State:

Vax Date: 01/08/2021
Onset Date: 01/19/2021
Rec V Date: 08/11/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Diarrhoea, Nasal congestion

Symptoms: Hot at the site; Itchy at the site; Rash at the site; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE WARMTH (Hot at the site), VACCINATION SITE PRURITUS (Itchy at the site) and VACCINATION SITE RASH (Rash at the site) 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 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Hot at the site), VACCINATION SITE PRURITUS (Itchy at the site) and VACCINATION SITE RASH (Rash at the site). At the time of the report, VACCINATION SITE WARMTH (Hot at the site), VACCINATION SITE PRURITUS (Itchy at the site) and VACCINATION SITE RASH (Rash at the 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. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1543334
Sex: F
Age: 34
State: TX

Vax Date: 01/05/2021
Onset Date: 01/05/2021
Rec V Date: 08/11/2021
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: MEDICAL HISTORY (Patient): The patient's past medical history included Alcoholic (1 drink/ week ,patient stop drinking on 01-Jul-2020) in 2011, Pregnancy (live full term birth) on 08-May-2016, Pregnancy (live full term birth) on 27-Feb-2018 and Miscarriage on 18-Jun-2020. Concomitant products included Colace for Constipation, MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for Pregnancy, VITAMIN D NOS for Prevention, FAMOTIDINE (PEPCID AC) for Reflux esophagitis. On 05-Jan-2021 at 12:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021 at 10:15 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 18-Jun-2020 and the estimated date of delivery was 31-Mar-2021. On 05-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Got vaccine during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the twenty-eighth week of the pregnancy. On 05-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Got vaccine during pregnancy) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Nov-2020, Ultrasound antenatal screen normal: normal (normal) normal. On 16-Dec-2020, Glucose tolerance test: normal (normal) normal. On 03-Feb-2021, Ultrasound antenatal screen normal: normal (normal) normal. Treatment information not provided. Most recent FOLLOW-UP information incorporated above includes: On 04-Feb-2021: internal review on 21-JUL-2021 to update analysis and patient pregnancy details. On 25-Jun-2021: follow-up received on 25-Jun-2021 contains no new information

Other Meds: PEPCID AC; Colace; PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]; VITAMIN D NOS

Current Illness:

ID: 1543335
Sex: F
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List: Rash, Urticaria

Symptoms: pregnant; This spontaneous prospective pregnancy case was reported by a nurse and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (pregnant) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (pregnant). At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (pregnant) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication was provided. No treatment information was provided.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.

Other Meds:

Current Illness:

ID: 1543336
Sex: F
Age:
State: TN

Vax Date: 01/11/2021
Onset Date: 01/11/2021
Rec V Date: 08/11/2021
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: Her back felt like it was about to break; Sinus was messed up; Feeling really bad; Her muscle still feels kinda sore; A spontaneous report was received from a consumer concerning a 73-year-old, female patient who experienced her muscle feeling sore (myalgia), sinus was messed up (sinus disorder), feeling really bad (malaise) and her back felt like it was about to break (back pain). The patient's medical history included shingles. Concomitant products known to have been used by the patient, within two weeks prior to the event, included iron, vitamin B12, spironolactone, vitamin C, zinc, vitamin D, and rosuvastatin. The patient received their first dose of mRNA-1273 on 11 Jan 2021 for prophylaxis of COVID-19 infection. On 11 Jan 2021, after the patient received her vaccine, her back felt like it was about to break, her muscle still felt like it was sore. The patient's sinus was messed up and she felt really bad. Treatments of these events included paracetamol, acetylsalicylic acid and pseudoephedrine. Action taken with mRNA-1273 in response to the event was unknown. The outcomes of the events, muscle feeling sore, feeling really bad, sinus messed up and back felt like it was about to break were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds: IRON; VITAMIN B12 [CYANOCOBALAMIN]; SPIRONOLACTONE; VITAMIN C [ASCORBIC ACID]; ZINC; VITAMIN D [COLECALCIFEROL]; CRESTOR

Current Illness:

ID: 1543337
Sex: F
Age: 32
State:

Vax Date: 02/03/2021
Onset Date: 02/03/2021
Rec V Date: 08/11/2021
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: arm soreness; pregnancy; This spontaneous prospective pregnancy case was reported by a physician and describes the occurrence of PAIN IN EXTREMITY (arm soreness) and MATERNAL EXPOSURE DURING PREGNANCY (pregnancy) in a 32-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. No medical history information provided. Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for Prenatal care, ALUMINIUM HYDROXIDE GEL, DRIED, MAGNESIUM CARBONATE (PEPCID [ALUMINIUM HYDROXIDE GEL, DRIED;MAGNESIUM CARBONATE]) for an unknown indication. On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The patient's last menstrual period was on 25-Aug-2020 and the estimated date of delivery was 25-May-2021. On 03-Feb-2021, the patient experienced PAIN IN EXTREMITY (arm soreness) and MATERNAL EXPOSURE DURING PREGNANCY (pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the twenty-third week of the pregnancy. The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Unknown. On 03-Feb-2021, MATERNAL EXPOSURE DURING PREGNANCY (pregnancy) had resolved. At the time of the report, PAIN IN EXTREMITY (arm soreness) 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 treatment information was provided.

Other Meds: PEPCID [ALUMINIUM HYDROXIDE GEL, DRIED;MAGNESIUM CARBONATE]; PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]

Current Illness:

ID: 1543338
Sex: F
Age: 35
State: IN

Vax Date: 02/03/2021
Onset Date: 02/03/2021
Rec V Date: 08/11/2021
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: Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. No Medical History information was reported. On 03-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 08-Nov-2020 and the estimated date of delivery was 08-Aug-2021. On 03-Feb-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the twelfth week of the pregnancy. On 03-Feb-2021, EXPOSURE DURING PREGNANCY (Pregnant) 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: 1543339
Sex: F
Age:
State:

Vax Date: 02/01/2021
Onset Date: 02/01/2021
Rec V Date: 08/11/2021
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: pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (pregnant) 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 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 01-Feb-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (pregnant). On 01-Feb-2021, MATERNAL EXPOSURE DURING PREGNANCY (pregnant) had resolved. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant meds were provided. No treatment information provided.

Other Meds:

Current Illness:

ID: 1543340
Sex: F
Age: 34
State: MD

Vax Date: 01/13/2021
Onset Date: 01/13/2021
Rec V Date: 08/11/2021
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: Heart was racing really fast; Shortness of Breath; Tightness on the chest; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Heart was racing really fast), DYSPNOEA (Shortness of Breath) and CHEST DISCOMFORT (Tightness on the chest) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination. No Medical History information was reported. On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced PALPITATIONS (Heart was racing really fast), DYSPNOEA (Shortness of Breath) and CHEST DISCOMFORT (Tightness on the chest). The patient was treated with METOPROLOL (oral) for Hypertension, at a dose of 1 dosage form and LORAZEPAM (oral) for Anxiety, at a dose of 1 dosage form. At the time of the report, PALPITATIONS (Heart was racing really fast), DYSPNOEA (Shortness of Breath) and CHEST DISCOMFORT (Tightness on the chest) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications details were not reported by the reporter.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1543341
Sex: F
Age: 63
State: DC

Vax Date: 01/04/2021
Onset Date: 01/04/2021
Rec V Date: 08/11/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Ear pain, Hypoaesthesia

Symptoms: 3 papules on chest; Scabe on shoulder; Itchy Rash on Right Shoulder and Chest; Extreme itching on Right shoulder and chest; Experienced soreness, achiness and periodic sharp pain in Right Foot; Soreness; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN (Soreness), PAIN IN EXTREMITY (Experienced soreness, achiness and periodic sharp pain in Right Foot), PRURITUS (Extreme itching on Right shoulder and chest), RASH PRURITIC (Itchy Rash on Right Shoulder and Chest) and SCAB (Scabe on shoulder) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event (No Historical condition reported). Concomitant products included PARACETAMOL (TYLENOL) for an unknown indication. On 04-Jan-2021 at 8:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jan-2021, the patient experienced PAIN (Soreness). On 14-Jan-2021, the patient experienced PAIN IN EXTREMITY (Experienced soreness, achiness and periodic sharp pain in Right Foot). On 18-Jan-2021 at 2:00 PM, the patient experienced PRURITUS (Extreme itching on Right shoulder and chest). On 18-Jan-2021 at 8:00 PM, the patient experienced RASH PRURITIC (Itchy Rash on Right Shoulder and Chest). 18-Jan-2021 at 8:00 PM, the patient experienced SCAB (Scabe on shoulder) and PAPULE (3 papules on chest). At the time of the report, PAIN (Soreness), PAIN IN EXTREMITY (Experienced soreness, achiness and periodic sharp pain in Right Foot), PRURITUS (Extreme itching on Right shoulder and chest), RASH PRURITIC (Itchy Rash on Right Shoulder and Chest), SCAB (Scabe on shoulder) and PAPULE (3 papules on chest) had not 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 treatment information was provided.

Other Meds: TYLENOL

Current Illness:

ID: 1543342
Sex: F
Age: 29
State: TX

Vax Date: 02/04/2021
Onset Date: 02/04/2021
Rec V Date: 08/11/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Abdominal pain upper, Dizziness, Dysgeusia

Symptoms: vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. The patient's past medical history included Alcohol use. Concurrent medical conditions included Pregnancy since August 2020. Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication. On 04-Feb-2021 at 1:45 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was in July 2020 and the estimated date of delivery was on an unknown date. On 04-Feb-2021, the patient experienced EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy. On 04-Feb-2021, EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In August 2020, Pregnancy test: positive (Positive) positive. On 03-Dec-2020, Ultrasound abdomen: normal (normal) normal. In January 2021, Glucose tolerance test: 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. Patient estimated due date is on an unknown date in APR 2021. No information was provided on concomitant medication. No treatment information was provided.

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

Current Illness: Pregnancy

ID: 1543343
Sex: F
Age: 56
State: IL

Vax Date: 01/11/2021
Onset Date: 01/11/2021
Rec V Date: 08/11/2021
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: welts; injection site redness; injection site pain; headache; A spontaneous report was received from a consumer concerning a 57- year old-white-female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced injection site urticaria,injection site erythema,injection site pain and headache. The patient's medical history was not provided.No relevant concomitant medications were reported. On 11-Jan-2021,prior to the onset of the events, the patient received their planned dose of mRNA-1273 (lot/batch 026L20A) intramuscularly on right arm for prophylaxis of COVID-19 infection. On 11-jan-2021,the patient experienced injection site was red and was very sore and had a welt. she did get a headache then everything went away and she felt great. Then on the 20Jan2021 the site became red again but was not sore but the size became the half dollar. No laboratory data was provided.Treatment information was not provided. Action taken with mRNA-1273 in response to the events was unknown. The outcome of the events injection site urticaria,injection site pain and headache was considered as resolved at the time of the report.The outcome of the event injection site erythema was considered as not resolved at the time of the report

Other Meds:

Current Illness:

ID: 1543344
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/11/2021
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: Face was swollen; Bad result from the injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Bad result from the injection) and SWELLING FACE (Face was swollen) in a female 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (Bad result from the injection) and SWELLING FACE (Face was swollen). At the time of the report, VACCINATION SITE REACTION (Bad result from the injection) and SWELLING FACE (Face was swollen) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided by the reporter. No treatment information was provided.

Other Meds:

Current Illness:

ID: 1543345
Sex: F
Age: 81
State: OH

Vax Date: 01/19/2021
Onset Date: 01/20/2021
Rec V Date: 08/11/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Unevaluable event

Symptoms: cheek bones hurt underneath her eyes.; Experienced chest pain; Experienced arm soreness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of FACIAL PAIN (cheek bones hurt underneath her eyes.), CHEST PAIN (Experienced chest pain) and VACCINATION SITE PAIN (Experienced arm soreness at the injection site) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included Knee replacement, Stent placement (Kidney stent.), Hysterectomy and Diverticulitis (Diverticulitis surgery(bagged then reversal).). Concurrent medical conditions included Aching in knees, Bladder discomfort, Migraine, Back pain, Sciatic nerve injury (Sciatic nerve pain.), Blood pressure inadequately controlled (High Blood pressure), Acid reflux (esophageal), Penicillin allergy, Allergy (Sulfa allergy.), Allergy (Codeine allergy.), Iodine allergy, Allergy (Morphine allergy.), Allergy (Patient reported: NSAID's (can't take due to bad kidneys).), Allergy (Ultram allergy.), Allergy (Cymbalta allergy.) and Allergy (Requip allergy. Reporter mentioned:Requip (hallucinated).). Concomitant products included ZOLMITRIPTAN (ZOMIG) for Migraine, HYDROCODONE BITARTRATE, PARACETAMOL (VICODIN) for Pain, CLOPIDOGREL BISULFATE (PLAVIX), MIRABEGRON (MYRBETRIQ), FESOTERODINE FUMARATE (TOVIAZ), FAMOTIDINE, CALCIUM CITRATE, COLECALCIFEROL (CITRACAL + D3), DOCUSATE (Col-rite), GABAPENTIN (NEURONTIN), LUTEIN [XANTOFYL], ROSUVASTATIN CALCIUM (CRESTOR) and OLMESARTAN MEDOXOMIL (BENICAR) for an unknown indication. On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced FACIAL PAIN (cheek bones hurt underneath her eyes.), CHEST PAIN (Experienced chest pain) and VACCINATION SITE PAIN (Experienced arm soreness at the injection site). On 20-Jan-2021, FACIAL PAIN (cheek bones hurt underneath her eyes.) and CHEST PAIN (Experienced chest pain) had resolved. At the time of the report, VACCINATION SITE PAIN (Experienced arm soreness at the injection site) had not resolved. The consumer reported that on 20JAN2021, her cheek bones hurt underneath her eyes, and she experienced chest pain. Both events lasted 20 minutes and resolved. She reported that she pushed on her face to help with the pain and held her chest. No treatment medication reported. That same night, she again experienced and reported that her cheek bones hurt underneath her eyes and she experienced chest pain. This time, these same events lasted 30 minutes and resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds: PLAVIX; MYRBETRIQ; TOVIAZ; FAMOTIDINE; CITRACAL + D3; Col-rite; NEURONTIN; LUTEIN [XANTOFYL]; CRESTOR; BENICAR; ZOMIG; VICODIN

Current Illness: Aching in knees; Allergy (Ultram allergy.); Allergy (Sulfa allergy.); Allergy (Requip allergy. Reporter mentioned:Requip (hallucinated).); Allergy (Patient reported: NSAID's (can't take due to bad kidneys).); Allergy (Morphine allergy.); Allergy (Codeine allergy.); Iodine allergy; Penicillin allergy

ID: 1543346
Sex: M
Age: 75
State: TX

Vax Date: 01/07/2021
Onset Date: 01/07/2021
Rec V Date: 08/11/2021
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: Tingling; Rash; The rash was also at my knees extending about 10 inches up; Sinus infection; A spontaneous report was received on 21-JAN-2021 from a consumer, concerning male patient of 75 years old, who received Moderna's COVID-19 vaccine and experienced : Sinus infection when he got the vaccine, hands started tingling, rash appeared between his fingers, extending up to his shoulders on each arm, rash was also at his knees extending about 10 inches up. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 07-JAN-2021, the patient received her first dose of the Modena vaccine mRNA-1273((Lot # Unknown) via unknown route for COVID-19 infection prophylaxis. 18-JAN-2021 he went to the ER for his rash, but no lab data was provided by the reporter and he was prescribed with steroids and Benadryl. As a treatment medication he has taken diphenhydramine HCl (Benadryl), Amoxylin, Calamine lotion and steroids as a treatment in response to the event with mRNA-1273. The outcome of the events Sinus infection when he got the vaccine, hands started tingling, rash appeared between his fingers, extending up to his shoulders on each arm, rash was also at his knees extending about 10 inches up. was considered to be Not Recovered/Not Resolved at the time of this report.

Other Meds:

Current Illness:

ID: 1543347
Sex: F
Age:
State:

Vax Date: 01/06/2021
Onset Date:
Rec V Date: 08/11/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site pain, Pain

Symptoms: Diarrhea; Muscle weakness inability to work fingers on hand/Muscle weakness; Inability to "work" my fingers on that hand; Burning sensation in neck and head; Itchiness/ Pruritus; Palpitations; Tingling; Local arm soreness; Feeling hot; Red Eye; Large red welt/ Hives; Red/ Redness; Feeling worsens; Painful; It is like a very heavy weight; Does impede my daily work functions; Numbness; Rash; Chills; Headache; This spontaneous case was reported by an other health care professional and describes the occurrence of DIARRHOEA (Diarrhea), MUSCULAR WEAKNESS (Muscle weakness inability to work fingers on hand/Muscle weakness), DYSKINESIA (Inability to "work" my fingers on that hand), BURNING SENSATION (Burning sensation in neck and head) and PRURITUS (Itchiness/ Pruritus) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025L20A and 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Hay fever. Concomitant products included MULTIVITAMINS [VITAMINS NOS], MAGNESIUM, VITAMIN B NOS (B-COMPLEX [VITAMIN B NOS]), LEVOTHYROXINE, LIOTHYRONINE (NP THYROID) and KRILL OIL for an unknown indication. On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to at an unspecified dose. On an unknown date, the patient experienced DIARRHOEA (Diarrhea), MUSCULAR WEAKNESS (Muscle weakness inability to work fingers on hand/Muscle weakness), DYSKINESIA (Inability to "work" my fingers on that hand), BURNING SENSATION (Burning sensation in neck and head), PRURITUS (Itchiness/ Pruritus), PALPITATIONS (Palpitations), PARAESTHESIA (Tingling), PAIN IN EXTREMITY (Local arm soreness), FEELING HOT (Feeling hot), OCULAR HYPERAEMIA (Red Eye), URTICARIA (Large red welt/ Hives), ERYTHEMA (Red/ Redness), CONDITION AGGRAVATED (Feeling worsens), PAIN (Painful), FEELING ABNORMAL (It is like a very heavy weight), IMPAIRED WORK ABILITY (Does impede my daily work functions), HYPOAESTHESIA (Numbness), RASH (Rash), CHILLS (Chills) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, DIARRHOEA (Diarrhea) and HEADACHE (Headache) had resolved, MUSCULAR WEAKNESS (Muscle weakness inability to work fingers on hand/Muscle weakness), DYSKINESIA (Inability to "work" my fingers on that hand), BURNING SENSATION (Burning sensation in neck and head), PAIN IN EXTREMITY (Local arm soreness) and URTICARIA (Large red welt/ Hives) had not resolved and PRURITUS (Itchiness/ Pruritus), PALPITATIONS (Palpitations), PARAESTHESIA (Tingling), FEELING HOT (Feeling hot), OCULAR HYPERAEMIA (Red Eye), ERYTHEMA (Red/ Redness), CONDITION AGGRAVATED (Feeling worsens), PAIN (Painful), FEELING ABNORMAL (It is like a very heavy weight), IMPAIRED WORK ABILITY (Does impede my daily work functions), HYPOAESTHESIA (Numbness), RASH (Rash) and CHILLS (Chills) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. The treatment medication include the NSAID. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was not applicable. This case was linked to MOD-2021-104489 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 27-Jun-2021: Follow-up received included patient demographic details included race and ethnicity; relevant history details included hay fever; concomitant medication details included multivitamin, magnesium, B-complex, NP-thyroid and krill oil; suspect vaccine re-challenge detail; new adverse events rash, chills, palpitations, tingling, itchy eyes, numbness and feeling hot; treatment medications included Tylenol, Epinephrine and Benedryl.

Other Meds: MULTIVITAMINS [VITAMINS NOS]; MAGNESIUM; B-COMPLEX [VITAMIN B NOS]; NP THYROID; KRILL OIL

Current Illness:

ID: 1543348
Sex: F
Age: 37
State: MI

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

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

Lab Data:

Allergies:

Symptom List: Injection site pain, Menorrhagia

Symptoms: exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (exposure during pregnancy) in a 37-year-old female patient (gravida 4, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. The patient's past medical history included Stillbirth (16 weeks 2 days due to infection) on 11-Jul-2019 and Induced abortion (Induced Abortion at 6 weeks and 6 days trisomy 17 triploid. At 10 weeks had DNC.) on 11-Feb-2020. Concurrent medical conditions included Difficulty with anesthesia (Anesthesia sensitivity) and Ex-alcohol user (2-4 drinks a month (prior use)). Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) and FISH OIL (OMEGA 3 [FISH OIL]) for an unknown indication. On 03-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 09-Jul-2020 and the estimated date of delivery was 15-Apr-2021. On 03-Feb-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the thirtieth week of the pregnancy. On 03-Feb-2021, MATERNAL EXPOSURE DURING PREGNANCY (exposure during pregnancy) had resolved. Not Provided DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Aug-2020, Pregnancy test: positive (Positive) positive. On an unknown date, Blood glucose: normal (normal) normal. On an unknown date, Ultrasound antenatal screen: normal (normal) At 19 weeks and normal (normal) At 28 weeks. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Treatment information was not provided.

Other Meds: PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]; OMEGA 3 [FISH OIL]

Current Illness: Difficulty with anesthesia (Anesthesia sensitivity); Ex-alcohol user (2-4 drinks a month (prior use))

ID: 1543349
Sex: F
Age: 68
State: TX

Vax Date: 01/11/2021
Onset Date: 01/12/2021
Rec V Date: 08/11/2021
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: Golf-sized lump in my arm; Body aches real bad; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Golf-sized lump in my arm), MYALGIA (Body aches real bad) and NAUSEA (Nausea) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. No Medical History information was reported. On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Jan-2021, the patient experienced VACCINATION SITE MASS (Golf-sized lump in my arm), MYALGIA (Body aches real bad) and NAUSEA (Nausea). On 12-Jan-2021, MYALGIA (Body aches real bad) had resolved. On 13-Jan-2021, NAUSEA (Nausea) had resolved. At the time of the report, VACCINATION SITE MASS (Golf-sized lump in my arm) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medications details were not reported by the reporter. Treatment details were not reported by the reporter.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1543350
Sex: F
Age:
State: GA

Vax Date: 01/17/2021
Onset Date: 01/20/2021
Rec V Date: 08/11/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Nausea, Pain in extremity, Pyrexia

Symptoms: Itches; Rash on right shoulder; A spontaneous report was received from a (Consumer) concerning a ? 89Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events (PT term) list. The patient's medical history was not provided. No relevant concomitant medications were reported. On17JAN2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 028LZON ) intramuscularly in the Anatomical location for prophylaxis of COVID-19 infection. On17JAN2021, The patient experienced the events list (verbatims) with seriousness criteria. Moderna Customer Care. Case Number 00030215 Patient reaceived the first dose of the Moderna Covid-19 vaccine on the 17JAN2021 on her left and yesterday, she noticed rash on right shoulder and it itches.On the first day after receiving the vaccine, she took ibuprofen and 4 hours later she took it again. Patient is an 89 year old female. She takes vitamins, Prevagen, Losartan, Amlodipine. She received the vaccine at a Pharmacy. Lot number 028LZON Consent was received for safety to follow-up and for this call to be documented. She wants to know when she will receive her second dose and How will she find out about it. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. unknown outcomes: At the time of this report, the outcome of the event(s) (when there are multiple events, list out which events are being referenced here) was unknown>.

Other Meds: VITAMINS NOS; PREVAGEN [APOAEQUORIN;COLECALCIFEROL]; LOSARTAN; AMLODIPINE

Current Illness:

ID: 1543351
Sex: F
Age: 67
State: NV

Vax Date: 01/20/2021
Onset Date: 01/20/2021
Rec V Date: 08/11/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 04-Feb-2021 and was forwarded to Moderna on 04-Feb-2021. This spontaneous case was reported by a consumer and describes the occurrence of INCORRECT PRODUCT ADMINISTRATION DURATION (scheduled to receive 2nd dose of the moderna vaccine 50 days instead of 21-42 day after 1st dose) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032120A) for COVID-19 vaccination. No Medical History information was reported. On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jan-2021, the patient experienced INCORRECT PRODUCT ADMINISTRATION DURATION (scheduled to receive 2nd dose of the moderna vaccine 50 days instead of 21-42 day after 1st dose). At the time of the report, INCORRECT PRODUCT ADMINISTRATION DURATION (scheduled to receive 2nd dose of the moderna vaccine 50 days instead of 21-42 day after 1st dose) had resolved. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Patient received the first dose of Moderna covid-19 vaccine on 20-Jan-2021 and reported that she is scheduled on 11-Mar-2021 to receive the second dose which is a 50 days instead of 21-42 days. Patient stated that she hadn't scheduled yet. No concomitant medications were reported. No treatment information was reported

Other Meds:

Current Illness:

ID: 1543352
Sex: M
Age: 56
State: MI

Vax Date: 02/03/2021
Onset Date: 02/03/2021
Rec V Date: 08/11/2021
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: few dots of blood on the Band Aid; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE HAEMORRHAGE (few dots of blood on the Band Aid.) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) 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) (Intramuscular) at an unspecified dose. On an unknown date, the patient experienced VACCINATION SITE HAEMORRHAGE (few dots of blood on the Band Aid.). The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.

Other Meds:

Current Illness:

ID: 1543353
Sex: F
Age: 27
State: KS

Vax Date: 01/05/2021
Onset Date:
Rec V Date: 08/11/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Nausea

Symptoms: 8 weeks pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (8 weeks pregnant) in a 27-year-old female patient (gravida 3, para 2) who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 05-Jan-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 an unknown date and the estimated date of delivery was 16-Sep-2021. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (8 weeks pregnant). At the time of the report, EXPOSURE DURING PREGNANCY (8 weeks pregnant) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (8 weeks pregnant) in a 27-year-old female patient (gravida 4) who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included Pregnancy. On 05-Jan-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 an unknown date and the estimated date of delivery was 16-Sep-2021. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (8 weeks pregnant). The delivery occurred on 15-Sep-2021. For neonate 1, The outcome was reported as Unknown. At the time of the report, EXPOSURE DURING PREGNANCY (8 weeks pregnant) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Most recent FOLLOW-UP information incorporated above includes: On 29-Jan-2021: No specific follow-up information recorded. No significant information on follow-up. Most recent FOLLOW-UP information incorporated above includes: On 29-Jan-2021: No specific follow-up information recorded.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 27-year-old female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.

Other Meds:

Current Illness:

ID: 1543354
Sex: F
Age: 28
State: TX

Vax Date: 01/29/2021
Onset Date: 01/29/2021
Rec V Date: 08/11/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site pain

Symptoms: Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) in a 28-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 29-Jan-2021 at 11:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The patient's last menstrual period was on 14-Oct-2020 and the estimated date of delivery was 21-Jul-2021. On 29-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the fifteenth week of the pregnancy. At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medications was not reported . Treatment history was not reported . Previous pregnancy end date was 04 Oct 2018 outcome was live birth.

Other Meds:

Current Illness:

ID: 1543355
Sex: F
Age: 32
State:

Vax Date: 12/30/2020
Onset Date: 12/30/2020
Rec V Date: 08/11/2021
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: pregnant; Experienced sore arm both times; This spontaneous prospective pregnancy case was reported by a physician and describes the occurrence of EXPOSURE DURING PREGNANCY (pregnant) and PAIN IN EXTREMITY (Experienced sore arm both times) in a 32-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025J20A and 028L20A) for COVID-19 vaccination. No Medical History was provided by the reporter. Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication. On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 25-Sep-2021. On 30-Dec-2020, the patient experienced EXPOSURE DURING PREGNANCY (pregnant) and PAIN IN EXTREMITY (Experienced sore arm both times). On 30-Dec-2020, EXPOSURE DURING PREGNANCY (pregnant) had resolved. At the time of the report, PAIN IN EXTREMITY (Experienced sore arm both times) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No treatment information was provided.

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

Current Illness:

ID: 1543356
Sex: F
Age:
State: CA

Vax Date: 01/12/2021
Onset Date: 01/12/2021
Rec V Date: 08/11/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Sweats; Injection site hot to touch; Redness on the injeciton site; Fatigue; Headache; Fever; Nausea; Chills; This spontaneous case was reported by an other health care professional and describes the occurrence of HYPERHIDROSIS (Sweats), VACCINATION SITE WARMTH (Injection site hot to touch), VACCINATION SITE ERYTHEMA (Redness on the injeciton site), FATIGUE (Fatigue) and HEADACHE (Headache) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011J20A and 001B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Polycystic ovarian syndrome. Concurrent medical conditions included Drug allergy (Allergic to Codeine). On 12-Jan-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 12-Jan-2021, the patient experienced HYPERHIDROSIS (Sweats), VACCINATION SITE WARMTH (Injection site hot to touch), VACCINATION SITE ERYTHEMA (Redness on the injeciton site), FATIGUE (Fatigue), HEADACHE (Headache), PYREXIA (Fever), NAUSEA (Nausea) and CHILLS (Chills). On 17-Jan-2021, HEADACHE (Headache), PYREXIA (Fever), NAUSEA (Nausea) and CHILLS (Chills) had resolved. On 21-Jan-2021, FATIGUE (Fatigue) had resolved. At the time of the report, HYPERHIDROSIS (Sweats) had resolved and VACCINATION SITE WARMTH (Injection site hot to touch) and VACCINATION SITE ERYTHEMA (Redness on the injeciton site) had not resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications reported by reporter. Treatment medication not reported. Action taken with mRNA-1273 was not applicable. Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2021: Follow-up received on 22-Apr-2021: Added patient medical history, allergic conditions and update in events outcome.

Other Meds:

Current Illness: Drug allergy (Allergic to Codeine)

ID: 1543357
Sex: F
Age: 59
State: KY

Vax Date: 01/06/2021
Onset Date:
Rec V Date: 08/11/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Tremor

Symptoms: almost blacked out; Sweating; Vomiting (24 hours); Nausea; Fever (101); severe headache; A spontaneous report was received from a consumer concerning a female patient of unknown age who experienced fever (101), severe headache, nausea, sweating, vomiting (24 hours), and almost "blacked out".. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 06JAN2021, the patient received their first of two planned doses of mRNA-1273 (Batch number: 039k20a) intramuscularly for prophylaxis of COVID-19 infection. Patient called on 04Feb2021 to inquire about getting second dose of Moderna COVID-19 vaccine. She was concerned about the side effects she experienced after getting the first dose on 06Jan2021 (expiration date unknown). She is due for her second dose on 06Feb2021. The side effects she experienced were fever (101), severe headache, nausea, sweating, vomiting (24hours), and almost "blacked out". Patient was advised by HCP to contact Moderna before getting second dose. Treatment information included Tylenol and Zofran. The events, fever (101), severe headache, nausea, sweating, vomiting (24hours), and almost "blacked out". were considered recovered/resolved.

Other Meds:

Current Illness:

ID: 1543358
Sex: F
Age:
State: FL

Vax Date: 01/05/2021
Onset Date:
Rec V Date: 08/11/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Erythema, Pruritus

Symptoms: arm was "hot"; very itchy; rash at the injection site; red sport at site of injection; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE WARMTH (arm was "hot"), VACCINATION SITE PRURITUS (very itchy), VACCINATION SITE RASH (rash at the injection site) and VACCINATION SITE ERYTHEMA (red sport at site of injection) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included Breast cancer (Status is controlled.) since 1985, Breast cancer (Status is controlled.) since 2015, Breast cancer (Status is controlled.) in 2017 and Bypass surgery (Status is controlled.) in 2017. Concurrent medical conditions included Diabetes (Status is controlled.) since 2002, Penicillin allergy, Drug allergy (Codeine allergy), Food allergy (Citrus allergy) and Drug allergy (Sulfa allergy). Concomitant products included CLOPIDOGREL for Anticoagulant therapy, EXEMESTANE for Cancer, DULAGLUTIDE (TRULICITY) for Diabetes, LOSARTAN, CLONIDINE and METOPROLOL for Heart disease, unspecified, DEXLANSOPRAZOLE (DEXILANT) for Reflux gastritis, LEVOTHYROXINE for Thyroid disorder, METHENAMINE for UTI. On 05-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 VACCINATION SITE WARMTH (arm was "hot"), VACCINATION SITE PRURITUS (very itchy), VACCINATION SITE RASH (rash at the injection site) and VACCINATION SITE ERYTHEMA (red sport at site of injection). At the time of the report, VACCINATION SITE WARMTH (arm was "hot"), VACCINATION SITE PRURITUS (very itchy), VACCINATION SITE RASH (rash at the injection site) and VACCINATION SITE ERYTHEMA (red sport at site of injection) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Patient started to get a rash at the injection site. The rash was larger and very itchy. Cannot reach any of the doctors. Otherwise patient feels ok. Patient does not feel sick or have a fever. Due for second injection 02 Feb 2021 and does not know what to do. Treatment included antihistamine and cortisone cream. Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2021: New events added, Patient demographics added, Concomitant medications added

Other Meds: CLOPIDOGREL; LOSARTAN; CLONIDINE; METOPROLOL; EXEMESTANE; TRULICITY; LEVOTHYROXINE; METHENAMINE; DEXILANT

Current Illness: Breast cancer (Status is controlled.); Diabetes (Status is controlled.); Drug allergy (Sulfa allergy); Drug allergy (Codeine allergy); Food allergy (Citrus allergy); Penicillin allergy

ID: 1543359
Sex: M
Age:
State: NY

Vax Date: 01/13/2021
Onset Date: 01/15/2021
Rec V Date: 08/11/2021
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: Arm Soreness; Shoulder Soreness; A spontaneous report was received from a consumer concerning a male patient who received Moderna's Covid 19 vaccine and developed arm soreness and shoulder soreness. The patient's medical history and lab datas were not provided. Concomitant product used was not provided . The patient received his first dose of mRNA-1273 (Batch number: 013L20A), intramuscularly on 13-JAN-2021. On 15-JAN-2021, the patient developed arm soreness and shoulder soreness.The patient told that he is hypochondriac and didn't want to disclose his details. He also stated that two of his co-workers were also experiencing exactly the same AEs but didn't want to share/disclose their names. Treatment information was unknown. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the events were unknown.

Other Meds:

Current Illness:

ID: 1543360
Sex: F
Age: 84
State: IN

Vax Date: 01/11/2021
Onset Date: 01/19/2021
Rec V Date: 08/11/2021
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: Arm swelling with a size of 8x 9 cm; arm itching; A spontaneous report was received from a Physician concerning a 84-year-old, female patient who experienced arm swelling with a size of 8x 9 cm and Itching. The patient's medical history was not provided by the reporter. Concomitant medications reported included lisinopril and primidone. On 11-01-2021, time not specified, eight days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 013L20A) intramuscularly in the left deltoid .arm for prophylaxis of COVID-19 infection. On 19-01-2021, the patient experienced Arm swelling with a size of 8x 9 cm and Itching. The patient is still experiencing these symptoms. Treatment for the events was not provided. Action taken with mRNA-1273 in response to the events was not reported. The events, Arm swelling with a size of 8x 9 cm and Itching were considered not resolved.

Other Meds: LISINOPRIL; PRIMIDONE

Current Illness:

ID: 1543361
Sex: F
Age:
State: NJ

Vax Date: 01/12/2021
Onset Date: 01/14/2021
Rec V Date: 08/11/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Asthenia, Chills, Headache, Myalgia

Symptoms: Felt cold/chilly; Swollen, stiff, red knuckles and joints; Sensitive to the temperature; Swollen, stiff, red knuckles and joints; Tired; Itchy and hot again; Rash around the injection site; Red, hot, knot at the injection site; Red, hot, knot at the injection site; Red, hot, knot at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Red, hot, knot at the injection site), VACCINATION SITE MASS (Red, hot, knot at the injection site), FEELING COLD (Felt cold/chilly), JOINT SWELLING (Swollen, stiff, red knuckles and joints) and TEMPERATURE INTOLERANCE (Sensitive to the temperature) in a 92-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. No Medical History information was reported. On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Red, hot, knot at the injection site), VACCINATION SITE MASS (Red, hot, knot at the injection site), VACCINATION SITE RASH (Rash around the injection site) and VACCINATION SITE ERYTHEMA (Red, hot, knot at the injection site). On 19-Jan-2021, the patient experienced PRURITUS (Itchy and hot again). On an unknown date, the patient experienced FEELING COLD (Felt cold/chilly), JOINT SWELLING (Swollen, stiff, red knuckles and joints), TEMPERATURE INTOLERANCE (Sensitive to the temperature), ERYTHEMA (Swollen, stiff, red knuckles and joints) and FATIGUE (Tired). At the time of the report, VACCINATION SITE WARMTH (Red, hot, knot at the injection site), VACCINATION SITE MASS (Red, hot, knot at the injection site), FEELING COLD (Felt cold/chilly), JOINT SWELLING (Swollen, stiff, red knuckles and joints), TEMPERATURE INTOLERANCE (Sensitive to the temperature), ERYTHEMA (Swollen, stiff, red knuckles and joints), PRURITUS (Itchy and hot again), VACCINATION SITE RASH (Rash around the injection site), VACCINATION SITE ERYTHEMA (Red, hot, knot at the injection site) and FATIGUE (Tired) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medication was not provided. Treatment include hot compress on the site to keep the vaccine flowing and cold compress on the site for when she was itchy. Most recent FOLLOW-UP information incorporated above includes: On 21-Jan-2021: Follow up received and it contain information about patient contact information updated and patient demographics updated and new events were added. On 04-Aug-2021: Non-sig follow up; patient's street address provided.

Other Meds:

Current Illness:

ID: 1543362
Sex: M
Age: 96
State: CA

Vax Date: 02/02/2021
Onset Date: 01/31/2021
Rec V Date: 08/11/2021
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: shocks on the ribs; patient fell from the bed; broken rib; A spontaneous report was received from a consumer concerning a 96 years-old, male patient who experienced shocks on the ribs: paraesthesia. The patient's medical history included a fall from bed on 31 Jan 2021 which resulted in broken left rib. Products known to have been used by the patient, within two weeks prior to the event, included dabigatran etexilate mesilate, furosemide sodium, cilostazol, levothyroxine, simvastatin, Tamsulosin, finasteride, and losartan. The patient received their first of two planned doses of mRNA-1273 (Lot #013M20A) intramuscularly, in the left arm on 02 Feb 2021 for prophylaxis of COVID-19 infection. On 04 Feb 2021, the patient started to feel little shocks on the ribs on the right side. The reporter wanted to know if the shocks were normal side effects. Treatment for the event included Tylenol. Action taken with mRNA-1273 was unknown. The outcome of event shocks on the ribs, was unknown.

Other Meds: TRADAXA; LASIX [FUROSEMIDE SODIUM]; CILOSTAZOL; LEVOTHYROXINE; SIMVASTATIN; TAMSULOSIN; FINASTERIDE; LOSARTAN

Current Illness:

ID: 1543363
Sex: M
Age: 81
State: TN

Vax Date: 01/01/2021
Onset Date: 01/19/2021
Rec V Date: 08/11/2021
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: Triangle raise red mark; Hurting very slightly at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Triangle raise red mark) and INJECTION SITE PAIN (Hurting very slightly at injection site) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination. No Medical History information was reported. On 01-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Triangle raise red mark) and INJECTION SITE PAIN (Hurting very slightly at injection site). At the time of the report, VACCINATION SITE ERYTHEMA (Triangle raise red mark) and INJECTION SITE PAIN (Hurting very slightly at injection site) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.

Other Meds:

Current Illness:

ID: 1543364
Sex: F
Age:
State: FL

Vax Date: 01/20/2021
Onset Date: 01/20/2021
Rec V Date: 08/11/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Pain in extremity

Symptoms: arm got hard and sore at the injection site; sore at the injection site; A spontaneous report was received from a (Consumer) concerning a ? 71Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events (PT term) list. The patient's medical history was not provided. No relevant concomitant medications were reported. On 20/Jan/2021 prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: if reported or unknown) intramuscularly in the Anatomical location for prophylaxis of COVID-19 infection. On 20/Jan/2021, The patient experienced the events list (verbatims) with seriousness criteria. Moderna Customer Care. Case Number 00030781 Patient states she received her first dose of the Moderna Covid-19 vaccine yesterday and her arm got hard and sore at the injection site and she wants to know if she can put ice at the site. Patient is a 71 year old female who received the vaccine in her left arm. She has not taken anything yet and takes Calcium, Biotin, Stool Softener, Collagen Powder. Consent for safety to follow-up was received and also to have this call documented. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. unknown outcomes: At the time of this report, the outcome of the event(s) (when there are multiple events, list out which events are being referenced here) was unknown>.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds: CALCIUM; BIOTIN; STOOL SOFTENER; COLLAGEN & MAGNESIUM

Current Illness:

ID: 1543365
Sex: F
Age: 31
State: TX

Vax Date: 01/16/2021
Onset Date: 01/16/2021
Rec V Date: 08/11/2021
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: SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE] and CALCIUM ACETATE for an unknown indication. On 16-Jan-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 an unknown date and the estimated date of delivery was 12-Jul-2021. On 16-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy). On 16-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. The patient reported that she learned she was pregnant on 03-Nov-2020. Her due date reported to be 12-Jul-2021. She reported her pre-pregnancy weight as 165 lbs and current weight as 170 lbs. Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2021: NNI

Other Meds: ZYRTEC ALLERGY; ALBUTEROL HFA; PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS ; CALCIUM ACETATE

Current Illness:

ID: 1543366
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/11/2021
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: side effects; Headache; chills; bodyache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (side effects), HEADACHE (Headache), CHILLS (chills) and MYALGIA (bodyache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (side effects), HEADACHE (Headache), CHILLS (chills) and MYALGIA (bodyache). At the time of the report, VACCINATION COMPLICATION (side effects), HEADACHE (Headache), CHILLS (chills) and MYALGIA (bodyache) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.

Other Meds:

Current Illness:

ID: 1543367
Sex: F
Age:
State: MA

Vax Date: 01/05/2021
Onset Date: 01/05/2021
Rec V Date: 08/11/2021
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: pregnant; This spontaneous prospective pregnancy case was reported by a nurse and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (pregnant) in a 40-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included Pregnancy on 09-Nov-2018 and Miscarriage on 01-Jun-2020. Concurrent medical conditions included Pregnancy since 25-Aug-2020. Concomitant products included VITAMIN D NOS, IRON, PARACETAMOL (TYLENOL) and CALCIUM MEFOLINATE (L METHYLFOLATE) for an unknown indication. On 05-Jan-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 01-Aug-2020 and the estimated date of delivery was 04-May-2021. On 05-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the twenty-second week of the pregnancy. On 05-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (pregnant) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Aug-2020, Pregnancy test: positive (Positive) Positive. In November 2020, Genetic counselling: ok normal. In November 2020, Puncture site haemorrhage: failed Failed. In November 2020, Ultrasound uterus normal: ok ok. 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. Patient had Live full-term birth on 09NOV2018 and had Miscarriage one 01JUN2020. patient took Tylenol 7times in pregnancy. 2nd dose is schedule on 2-feb-2021.

Other Meds: VITAMIN D NOS; IRON; TYLENOL; L METHYLFOLATE

Current Illness: Pregnancy

ID: 1543368
Sex: F
Age: 35
State: TX

Vax Date: 01/28/2021
Onset Date: 01/28/2021
Rec V Date: 08/11/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Vomiting

Symptoms: Pregnant; Headache; Sore arm; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant), HEADACHE (Headache) and MYALGIA (Sore arm) in a 35-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination. Concurrent medical conditions included Pregnancy since 12-Nov-2020. Concomitant products included DULOXETINE HYDROCHLORIDE (DULOXETINE DR) for Anxiety depression, MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for Pregnancy. On 28-Jan-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 03-Nov-2020 and the estimated date of delivery was 10-Aug-2021. On 28-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant), HEADACHE (Headache) and MYALGIA (Sore arm). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the twelfth week of the pregnancy. At the time of the report, EXPOSURE DURING PREGNANCY (Pregnant), HEADACHE (Headache) and MYALGIA (Sore arm) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Treatment information not provided.

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

Current Illness: Pregnancy

ID: 1543369
Sex: F
Age: 38
State: TX

Vax Date: 02/04/2021
Onset Date:
Rec V Date: 08/11/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Headache, Limb discomfort, Nasal congestion

Symptoms: maternal exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (maternal exposure during pregnancy) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 04-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 12-Dec-2020 and the estimated date of delivery was 18-Sep-2021. On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (maternal exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the seventh week of the pregnancy. At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (maternal exposure during pregnancy) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications was not provided. Treatment history was not reported.

Other Meds:

Current Illness:

ID: 1543370
Sex: F
Age: 77
State: AZ

Vax Date: 01/08/2021
Onset Date: 01/08/2021
Rec V Date: 08/11/2021
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: Pain in arm; Body ache; A rash at the injection site, not itchy,and getting large as pocket size; She felt light headed; She felt tired; A little bit sore the injection site; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (She felt light headed), PAIN (Body ache), PAIN IN EXTREMITY (Pain in arm), VACCINATION SITE RASH (A rash at the injection site, not itchy,and getting large as pocket size) and VACCINATION SITE PAIN (A little bit sore the injection site) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J202A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was provided by the reporter. The patient's past medical history included Guillain Barre syndrome. Previously administered products included for Product used for unknown indication: Flu shot. Concurrent medical conditions included Cholesterol since 1999 and Diverticulosis (Diverticulosis was kept in check with proper diet + Metamucil.) since 2002. Concomitant products included ROSUVASTATIN, ROSUVASTATIN CALCIUM (CRESTOR) and PRAVASTATIN SODIUM (PRAVACHOL) for Cholesterol, ASPIRIN [ACETYLSALICYLIC ACID] for Ischemic heart disease prophylaxis, PLANTAGO OVATA (METAMUCIL FIBRE THERAPY) for an unknown indication. On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced VACCINATION SITE PAIN (A little bit sore the injection site). On 09-Jan-2021, the patient experienced DIZZINESS (She felt light headed) and FATIGUE (She felt tired). On 09-Jan-2021 at 7:00 AM, the patient experienced VACCINATION SITE RASH (A rash at the injection site, not itchy,and getting large as pocket size). On 10-Jan-2021, the patient experienced PAIN (Body ache). On an unknown date, the patient experienced PAIN IN EXTREMITY (Pain in arm). The patient was treated with PARACETAMOL (TYLENOL) on 10-Jan-2021 at a dose of 2 dosage form. On 09-Jan-2021, DIZZINESS (She felt light headed) and FATIGUE (She felt tired) had resolved. On 10-Jan-2021, PAIN (Body ache) had resolved. On 11-Jan-2021, VACCINATION SITE PAIN (A little bit sore the injection site) had resolved. On 15-Feb-2021 at 7:00 AM, VACCINATION SITE RASH (A rash at the injection site, not itchy,and getting large as pocket size) had resolved. At the time of the report, PAIN IN EXTREMITY (Pain in arm) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Patient stated that rash developed got larger as the day passed. Size noted that size of silver dollar to the size of PAST-IT-NOTE, but round not square was noted. This case was linked to MOD-2021-250724 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2021: Follow-up received on 15-04-2021 has Reporter contact information updated. On 07-Jul-2021: Follow-up received on 07-JUL-2021 contains Patient Demographics, Medical Condition, Second dose information, concomitant Medications, Adverse Event Stop date.

Other Meds: METAMUCIL FIBRE THERAPY; ROSUVASTATIN; CRESTOR; PRAVACHOL; ASPIRIN [ACETYLSALICYLIC ACID]

Current Illness: Cholesterol; Diverticulosis (Diverticulosis was kept in check with proper diet + Metamucil.)

ID: 1543371
Sex: F
Age:
State: CA

Vax Date: 01/18/2021
Onset Date: 01/19/2021
Rec V Date: 08/11/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site swelling, Limb discomfort

Symptoms: Sore arm at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm at the injection site) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination. No Medical History information was reported. On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm at the injection site). On 20-Jan-2021, PAIN IN EXTREMITY (Sore arm at the injection site) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.

Other Meds:

Current Illness:

ID: 1543372
Sex: M
Age: 66
State: NC

Vax Date: 01/20/2021
Onset Date:
Rec V Date: 08/11/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Blood in Urine; Chills; High fever; Fatigue; Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD URINE PRESENT (Blood in Urine), CHILLS (chills), PYREXIA (high fever), FATIGUE (fatigue) and ARTHRALGIA (joint pain) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 016M20A) for COVID-19 vaccination. No Medical History information was reported. On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-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 BLOOD URINE PRESENT (Blood in Urine), CHILLS (chills), PYREXIA (high fever), FATIGUE (fatigue) and ARTHRALGIA (joint pain). At the time of the report, BLOOD URINE PRESENT (Blood in Urine), CHILLS (chills), PYREXIA (high fever), FATIGUE (fatigue) and ARTHRALGIA (joint pain) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged. Company comment: 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 No Concomitant Medicines were provided No Treatment medicines were provided This case was linked to US-MODERNATX, INC.-MOD-2021-076605 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 14-Apr-2021: Patient Demographics updated. Added four New Events Arthralgia, Fatigue, Chills, Pyrexia. Added Details of Second dose. Action taken with the drug was Updated from Unknown to No Change.; 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 US-MODERNATX, INC.-MOD-2021-076605:First dose

Other Meds:

Current Illness:

ID: 1543373
Sex: F
Age: 36
State:

Vax Date: 01/26/2021
Onset Date: 01/26/2021
Rec V Date: 08/11/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: maternal exposure during pregnancy; Sore arm after getting the vaccine; This spontaneous prospective pregnancy case was reported by a health care professional and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (maternal exposure during pregnancy) and VACCINATION SITE PAIN (Sore arm after getting the vaccine) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination. The patient's past medical history included No adverse event. On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 26-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (maternal exposure during pregnancy) and VACCINATION SITE PAIN (Sore arm after getting the vaccine). On 26-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (maternal exposure during pregnancy) had resolved. At the time of the report, VACCINATION SITE PAIN (Sore arm after getting the vaccine) outcome was unknown. Not Provided For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant product use was not reported. Treatment information was not provided. Most recent FOLLOW-UP information incorporated above includes: On 04-Feb-2021: Internal review on 19JUL2021 resulted in updates to pregnancy details.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 704,237

Page last modified: 26 October 2021 2:21am