chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Pregnancy test, Ultrasound antenatal screen
Clinical narrative: Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant) in a 27-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hypercholesterolemia since 2017. Concomitant products included CLINDAMYCIN and BENZOYL PEROXIDE for Acne, MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was in November 2020 and the estimated date of delivery was date. On 10-Feb-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy.  On 10-Feb-2021, EXPOSURE DURING PREGNANCY (Pregnant) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Dec-2020, Pregnancy test: positive (Positive) Positive. On 02-Dec-2020, Ultrasound antenatal screen:. On 17-Feb-2021, Ultrasound antenatal screen: normal (normal) Normal.         The patient's estimated date of conception is 24 Nov 2020. Treatment information was not provided.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Urinary tract infection
Clinical narrative: UTI; This spontaneous case was reported by a consumer and describes the occurrence of URINARY TRACT INFECTION (UTI) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     Concomitant products included METOPROLOL and APIXABAN (ELIQUIS) for an unknown indication.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced URINARY TRACT INFECTION (UTI). The patient was treated with CLARITHROMYCIN (MACROBID [CLARITHROMYCIN]) for Adverse event, at an unspecified dose and frequency. On 08-Mar-2021, URINARY TRACT INFECTION (UTI) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia oral
Clinical narrative: numbness of her tongue and lips; This spontaneous case was reported by a nurse and describes the occurrence of HYPOAESTHESIA ORAL (numbness of her tongue and lips) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy.    On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Mar-2021, the patient experienced HYPOAESTHESIA ORAL (numbness of her tongue and lips). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) (oral) for Adverse event, at a dose of 25 milligram. At the time of the report, HYPOAESTHESIA ORAL (numbness of her tongue and lips) 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.   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: NNI On 04-May-2021: Additional information received
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Flushing, Headache, Myalgia
Clinical narrative: he had only body aches; flushed; headache; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (he had only body aches), FLUSHING (flushed) and HEADACHE (headache) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 2 dosage form. On 06-Mar-2021, the patient experienced MYALGIA (he had only body aches), FLUSHING (flushed) and HEADACHE (headache). On 06-Mar-2021, FLUSHING (flushed) and HEADACHE (headache) had resolved. At the time of the report, MYALGIA (he had only body aches) had resolved.            No concomitant and treatment medications were provided.
Sex: M
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: Swelling noted on his body; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Swelling noted on his body) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SWELLING (Swelling noted on his body). At the time of the report, SWELLING (Swelling noted on his body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not reported  Treatment information was not provided
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Glucose tolerance test, Pregnancy test, Ultrasound scan
Clinical narrative: Patient is pregnant and received the first vaccine dose; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Patient is pregnant and received the first vaccine dose) in a 37-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A71A) for COVID-19 vaccination.     Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for Pregnancy.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was in October 2020 and the estimated date of delivery was 16-Jul-2021. On 06-Mar-2021, the patient experienced EXPOSURE DURING PREGNANCY (Patient is pregnant and received the first vaccine dose). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy.  On 06-Mar-2021, EXPOSURE DURING PREGNANCY (Patient is pregnant and received the first vaccine dose) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Oct-2020, Pregnancy test: positive (Positive) positive. On an unknown date, Glucose tolerance test: normal (normal) normal. On an unknown date, Ultrasound scan: normal (normal) normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       On an unknown date, the patient did Genetic testing and the findings were normal. Estimated date of conception was reported as 20-Oct-2020. The delivery date of previous pregnancy was reported as 07-Sep-2016.                No treatment information was provided.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Injection site erythema, Injection site pruritus
Clinical narrative: itchy; red; Little dizzy; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PRURITUS (itchy), INJECTION SITE ERYTHEMA (red) and DIZZINESS (Little dizzy) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE PRURITUS (itchy), INJECTION SITE ERYTHEMA (red) and DIZZINESS (Little dizzy). At the time of the report, INJECTION SITE PRURITUS (itchy), INJECTION SITE ERYTHEMA (red) and DIZZINESS (Little dizzy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not reported.  Treatment information was not provided
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Somnolence
Clinical narrative: Excessive Sleeping; Headache; Feeling Nauseous; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Excessive Sleeping), HEADACHE (Headache) and NAUSEA (Feeling Nauseous) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced SOMNOLENCE (Excessive Sleeping), HEADACHE (Headache) and NAUSEA (Feeling Nauseous). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, SOMNOLENCE (Excessive Sleeping), HEADACHE (Headache) and NAUSEA (Feeling Nauseous) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided Treatment information includes Tylenol
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness, Injection site nodule, Pruritus, Vaccination site erythema, Vaccination site pruritus
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (slight flu symptoms), VACCINATION SITE ERYTHEMA (where I got the shot, there's a red circle), VACCINATION SITE PRURITUS (slightly smaller than a tennis ball), INJECTION SITE NODULE (3 red little bumps) and PRURITUS (itchy) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination. Concomitant products included ATORVASTATIN, QUINAPRIL, FENOFIBRATE and NIACIN for an unknown indication. On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (slight flu symptoms), VACCINATION SITE ERYTHEMA (where I got the shot, there's a red circle), VACCINATION SITE PRURITUS (slightly smaller than a tennis ball), INJECTION SITE NODULE (3 red little bumps) and PRURITUS (itchy). At the time of the report, INFLUENZA LIKE ILLNESS (slight flu symptoms), VACCINATION SITE ERYTHEMA (where I got the shot, there's a red circle), VACCINATION SITE PRURITUS (slightly smaller than a tennis ball), INJECTION SITE NODULE (3 red little bumps) and PRURITUS (itchy) 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. concomitant medication: Metoprolol ER. Treatment information was not provided.
Age: 55.0
Sex: U
Vaccine: COVID19
Symptoms: Pruritus, Skin texture abnormal
Clinical narrative: back started itching; patient looked at her back and has darkish colored spots, the spots the texture of the skin has changed; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (back started itching) and SKIN TEXTURE ABNORMAL (patient looked at her back and has darkish colored spots, the spots the texture of the skin has changed) in a 55-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Feb-2021, the patient experienced PRURITUS (back started itching) and SKIN TEXTURE ABNORMAL (patient looked at her back and has darkish colored spots, the spots the texture of the skin has changed). At the time of the report, PRURITUS (back started itching) and SKIN TEXTURE ABNORMAL (patient looked at her back and has darkish colored spots, the spots the texture of the skin has changed) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported.  No treatment medication was reported.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pyrexia
Clinical narrative: fever; tired; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (tired) and PYREXIA (fever) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Mar-2021, the patient experienced FATIGUE (tired). On 08-Mar-2021, the patient experienced PYREXIA (fever). At the time of the report, FATIGUE (tired) and PYREXIA (fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Mar-2021, Pyrexia: 100.9.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not reported.  Treatment information was not provided.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Body temperature abnormal, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Temperature for a few hours; Left arm Itchy; Left arm is swollen; This spontaneous case was reported by a consumer and describes the occurrence of BODY TEMPERATURE ABNORMAL (Temperature for a few hours), VACCINATION SITE PRURITUS (Left arm Itchy) and VACCINATION SITE SWELLING (Left arm is swollen) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced BODY TEMPERATURE ABNORMAL (Temperature for a few hours), VACCINATION SITE PRURITUS (Left arm Itchy) and VACCINATION SITE SWELLING (Left arm is swollen). The patient was treated with PARACETAMOL (TYLENOL) for Body temperature abnormal, at an unspecified dose and frequency. On 03-Mar-2021, BODY TEMPERATURE ABNORMAL (Temperature for a few hours) had resolved. At the time of the report, VACCINATION SITE PRURITUS (Left arm Itchy) and VACCINATION SITE SWELLING (Left arm is swollen) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Mar-2021, Body temperature: abnormal (abnormal) abnormal.         No relevant concomitant medications were reported.  Treatment for the event includes paracetamol.   Reporter did not allow further contact
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersomnia, Vaccination complication
Clinical narrative: not feeling well; sleeping more than normal; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (not feeling well) and HYPERSOMNIA (sleeping more than normal) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included IMMUNOGLOBULIN HUMAN NORMAL (HIZENTRA) for an unknown indication.    On 27-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 2 dosage form. On 27-Feb-2021, the patient experienced VACCINATION COMPLICATION (not feeling well) and HYPERSOMNIA (sleeping more than normal). At the time of the report, VACCINATION COMPLICATION (not feeling well) and HYPERSOMNIA (sleeping more than normal) outcome was unknown.            Treatment information was not provided.  Action taken with mRNA-1273 in response to the event was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: Non-Significant follow up appended
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Headache, Pain
Clinical narrative: Soreness; Diarrhea on and off; Fatigue; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Soreness), DIARRHOEA (Diarrhea on and off), FATIGUE (Fatigue) and HEADACHE (Headache) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, the patient experienced PAIN (Soreness), DIARRHOEA (Diarrhea on and off), FATIGUE (Fatigue) and HEADACHE (Headache). At the time of the report, PAIN (Soreness), DIARRHOEA (Diarrhea on and off), FATIGUE (Fatigue) and HEADACHE (Headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication information was not provided.   Treatment medication information was not given.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Event outcome updated and declined further follow-up.
Sex: F
Vaccine: COVID19
Symptoms: Injection site discolouration, Pain in extremity, Pruritus
Clinical narrative: sore arm; Large pink spot; Itchy arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), INJECTION SITE DISCOLOURATION (Large pink spot) and PRURITUS (Itchy arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 21-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 PAIN IN EXTREMITY (sore arm), INJECTION SITE DISCOLOURATION (Large pink spot) and PRURITUS (Itchy arm). At the time of the report, PAIN IN EXTREMITY (sore arm), INJECTION SITE DISCOLOURATION (Large pink spot) and PRURITUS (Itchy arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not reported.  Treatment information was not provided.   This case was linked to MOD-2021-037749 (Patient Link).
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Hyperhidrosis, Injection site pain, Retching
Clinical narrative: chills/sweats; dry heaving; chills/sweats; sore arm at the site of the injection; This spontaneous case was reported by an other and describes the occurrence of HYPERHIDROSIS (chills/sweats), RETCHING (dry heaving), CHILLS (chills/sweats) and INJECTION SITE PAIN (sore arm at the site of the injection) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, the patient experienced HYPERHIDROSIS (chills/sweats), RETCHING (dry heaving), CHILLS (chills/sweats) and INJECTION SITE PAIN (sore arm at the site of the injection). On 25-Feb-2021, HYPERHIDROSIS (chills/sweats), RETCHING (dry heaving), CHILLS (chills/sweats) and INJECTION SITE PAIN (sore arm at the site of the injection) had resolved.            No concomitant medications were reported.  No treatment medication were reported.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Pain
Clinical narrative: Dizziness; Pain; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness) and PAIN (Pain) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Feb-2021, the patient experienced DIZZINESS (Dizziness) and PAIN (Pain). On 05-Feb-2021, DIZZINESS (Dizziness) and PAIN (Pain) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not reported.  Treatment information was not provided.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Injection site pain, Injection site reaction, Pain
Clinical narrative: hardness in arm; soreness to the touch in arm; tiredness; headaches; body aches; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE REACTION (hardness in arm), INJECTION SITE PAIN (soreness to the touch in arm), FATIGUE (tiredness), HEADACHE (headaches) and PAIN (body aches) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M208) for COVID-19 vaccination.     Concomitant products included SERTRALINE and BUPROPION HYDROCHLORIDE (WELLBUTRIN) for an unknown indication.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE REACTION (hardness in arm), INJECTION SITE PAIN (soreness to the touch in arm), FATIGUE (tiredness), HEADACHE (headaches) and PAIN (body aches). At the time of the report, INJECTION SITE REACTION (hardness in arm), INJECTION SITE PAIN (soreness to the touch in arm), FATIGUE (tiredness), HEADACHE (headaches) and PAIN (body aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: more than 36 days have passed since getting first dose; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (more than 36 days have passed since getting first dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE for an unknown indication.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (more than 36 days have passed since getting first dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (more than 36 days have passed since getting first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided.   This case was linked to MOD-2021-036120 (Patient Link).; Sender's Comments: This report refers to a case of Inappropriate schedule of product administration for mRNA-1273.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm tenderness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm tenderness) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 027L20A) 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. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 03-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (Arm tenderness). At the time of the report, PAIN IN EXTREMITY (Arm tenderness) outcome was unknown.       Concomitant product use was not reported.  Treatment information was not provided.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: After several days, I got a bad rash on lower arm; A spontaneous report was received from a consumer concerning herself, who is a 74-years-old female patient received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events after several days, i got a bad rash on lower arm, that went to my upper arm.  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 first of two planned doses of mRNA-1273 (lot/batch: Lot# 025J20A) via unknown route in the left arm for prophylaxis of COVID-19 infection.   On 17 Feb 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: Lot# 007M20A) via unknown route in the left arm for prophylaxis of COVID-19 infection.  On an unknown date, after receiving first dose the patient experienced the event bad rash on lower arm then that went to upper arm. Patient read online that said I got a covid arm.   Treatment of the rash include diphenhydramine, paracetamol, and ointment.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event after several days, i got a bad rash on lower arm, that went to my upper arm was resolved.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, White blood cell count
Clinical narrative: Bruising; This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION (Bruising) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No Medical history information was reported.  Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO) for Anxiety, MELATONIN for Insomnia, BIOTIN and MULTIVITAMINS [VITAMINS NOS] for an unknown indication.    On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced CONTUSION (Bruising). At the time of the report, CONTUSION (Bruising) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Mar-2021, White blood cell count: (Low) WBC being slightly below normal range.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       Other concomitant medication include: Multivitamins. Treatment information was not provided. Tested negative for Von Willebrand disease.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Patient height and weight updated. Concomitant medications Lexapro, biotin, multivitamis, melatonin added. AE Outcome updated as recovered.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Pregnancy test, Ultrasound scan
Clinical narrative: The patient's past medical history included Alcohol use (Prior use-twice monthly). Concurrent medical conditions included Migraine (Migraine with Aura), Anxiety and Allergic asthma. Concomitant products included ONDANSETRON (ZOFRAN MELT) for Nausea, DOXYLAMINE SUCCINATE (UNISOM 2), VITAMIN B6, VITAMIN D NOS and MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-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 01-May-2020 and the estimated date of delivery was 16-Feb-2021. On 09-Feb-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  forty-fourth week of the pregnancy. The delivery occurred  on 17-Feb-2021, which was reported as Full-term. For neonate 1, the birth weight was 3390 grams (7lbs 8oz). The outcome was reported as Term Birth NOS. Length of the baby was 51 cm and head circumference was 33 cm. On 09-Feb-2021, MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-May-2020, Pregnancy test: positive (Positive) positive. In February 2021, Ultrasound scan: normal (normal) normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   On 01 Mar 2017 and 15 Sep 2019 patient had  stillbirth. On 30 Jan 2018 and 17 Feb 2021 patient had full term birth. The estimated due date of conception was 14 May 2020. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: Follow up information was received and the patient demographics, past medical history, pregnancy information were updated.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain
Clinical narrative: Last night after shower I saw in the location of injection arm was red about 3 inches wide and 6-7; I had my arm sore for 4-5 days after the shot; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 23-Feb-2021 and was forwarded to Moderna on 08-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (I had my arm sore for 4-5 days after the shot) and VACCINATION SITE ERYTHEMA (Last night after shower I saw in the location of injection arm was red about 3 inches wide and 6-7) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 01M20A) for COVID-19 vaccination.     Concomitant products included LOSARTAN for an unknown indication.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced VACCINATION SITE PAIN (I had my arm sore for 4-5 days after the shot). On 22-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (Last night after shower I saw in the location of injection arm was red about 3 inches wide and 6-7). At the time of the report, VACCINATION SITE PAIN (I had my arm sore for 4-5 days after the shot) and VACCINATION SITE ERYTHEMA (Last night after shower I saw in the location of injection arm was red about 3 inches wide and 6-7) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pyrexia
Clinical narrative: Headache; Fatigue; Fever; This spontaneous case was reported by a physician and describes the occurrence of HEADACHE (Headache), FATIGUE (Fatigue) and PYREXIA (Fever) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 06-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage form. On 07-Mar-2021, the patient experienced HEADACHE (Headache), FATIGUE (Fatigue) and PYREXIA (Fever). On 08-Mar-2021, HEADACHE (Headache), FATIGUE (Fatigue) and PYREXIA (Fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   no treatment information was provided. no concomitant medications was provided.   Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: Additional Info: Possible NNI
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash that does not go away , which spread to the back.; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash that does not go away , which spread to the back.) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20A and 007M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced RASH (Rash that does not go away , which spread to the back.). At the time of the report, RASH (Rash that does not go away , which spread to the back.) outcome was unknown.            No relevant concomitant medications were reported.  No treatment information was provided.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Dry eye, Dry mouth, Ocular discomfort, Vision blurred
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of OCULAR DISCOMFORT (eyesight is not clear as it used to be), DRY EYE (eyes is dry.), VISION BLURRED (slight blurred) and DRY MOUTH (mouth feels dry as well.) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 03LM20A) for COVID-19 vaccination. Concurrent medical conditions included Blood pressure. Concomitant products included VENLAFAXINE HYDROCHLORIDE (FLAVIX) for an unknown indication. On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Mar-2021, the patient experienced OCULAR DISCOMFORT (eyesight is not clear as it used to be), DRY EYE (eyes is dry.), VISION BLURRED (slight blurred) and DRY MOUTH (mouth feels dry as well.). At the time of the report, OCULAR DISCOMFORT (eyesight is not clear as it used to be), DRY EYE (eyes is dry.), VISION BLURRED (slight blurred) and DRY MOUTH (mouth feels dry as well.) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant product : Blood pressure medication. Treatment information was not provided. Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: TCR.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Tooth extraction
Clinical narrative: Tooth extraction; This spontaneous case was reported by a consumer and describes the occurrence of TOOTH EXTRACTION (Tooth extraction) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 04DA21A) for COVID-19 vaccination.     No medical history was reported by the reporter.  Concomitant products included INSULIN HUMAN, INSULIN HUMAN INJECTION, ISOPHANE (INSULIN NOVOLIN), METFORMIN, METOPROLOL, LOSARTAN, HYDRALAZINE and AMLODIPINE for an unknown indication.    On 05-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced TOOTH EXTRACTION (Tooth extraction). At the time of the report, TOOTH EXTRACTION (Tooth extraction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. patient reported that she was given antibiotics.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: Chills; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CHILLS (Chills). At the time of the report, CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not reported.  Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Dyspepsia, Frequent bowel movements, Headache, Pain in extremity, Vomiting
Clinical narrative: Not so sore arm; headache; continuous bowel movements; Vomiting; severe indigestion; This spontaneous case was reported by a consumer and describes the occurrence of DYSPEPSIA (severe indigestion), PAIN IN EXTREMITY (Not so sore arm), HEADACHE (headache), FREQUENT BOWEL MOVEMENTS (continuous bowel movements) and VOMITING (Vomiting) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 2 dosage form. On 07-Mar-2021, the patient experienced DYSPEPSIA (severe indigestion), HEADACHE (headache), FREQUENT BOWEL MOVEMENTS (continuous bowel movements) and VOMITING (Vomiting). On an unknown date, the patient experienced PAIN IN EXTREMITY (Not so sore arm). On 08-Mar-2021, DYSPEPSIA (severe indigestion), FREQUENT BOWEL MOVEMENTS (continuous bowel movements) and VOMITING (Vomiting) had resolved. At the time of the report, PAIN IN EXTREMITY (Not so sore arm) and HEADACHE (headache) outcome was unknown.            No Concomitant Medications were provided. No treatment medications were provided.   This case was linked to MOD-2021-037723 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Cough, Inappropriate schedule of product administration, Malaise, SARS-CoV-2 test negative
Clinical narrative: Cough; 2nd dose of vaccine is scheduled for more than 35 days after 1st dose; symptoms of COVID; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (symptoms of COVID), COUGH (Cough) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose of vaccine is scheduled for more than 35 days after 1st dose) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included PARACETAMOL (TYLENOL) and BENZONATATE for an unknown indication.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced MALAISE (symptoms of COVID). On an unknown date, the patient experienced COUGH (Cough) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose of vaccine is scheduled for more than 35 days after 1st dose). At the time of the report, MALAISE (symptoms of COVID) and COUGH (Cough) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose of vaccine is scheduled for more than 35 days after 1st dose) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Mar-2021, SARS-CoV-2 test negative: negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was provided.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Fatigue, Injection site erythema, Injection site mass, Injection site pain
Clinical narrative: Arm started to itch on the same place they got the vaccine; Red spot; Hard lump; Little swollen; Warm  to the touch; Little back ache; Some redness that spread a little; Was a little sore; Tender; Tired; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of INJECTION SITE ERYTHEMA (Some redness that spread a little), INJECTION SITE PAIN (Was a little sore), TENDERNESS (Tender), FATIGUE (Tired) and INJECTION SITE PRURITUS (Arm started to itch on the same place they got the vaccine) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included MONTELUKAST for Allergy, ACETYLSALICYLIC ACID (BABY ASPIRIN), SERTRALINE and VITAMINS NOS for an unknown indication.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced INJECTION SITE ERYTHEMA (Some redness that spread a little), INJECTION SITE PAIN (Was a little sore), TENDERNESS (Tender) and FATIGUE (Tired). On 04-Mar-2021, the patient experienced INJECTION SITE PRURITUS (Arm started to itch on the same place they got the vaccine), INJECTION SITE ERYTHEMA (Red spot), INJECTION SITE MASS (Hard lump), INJECTION SITE SWELLING (Little swollen), INJECTION SITE WARMTH (Warm  to the touch) and BACK PAIN (Little back ache). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE, PARACETAMOL (TYLENOL PM) for Adverse event, at an unspecified dose and frequency. On 28-Feb-2021, INJECTION SITE ERYTHEMA (Some redness that spread a little), INJECTION SITE PAIN (Was a little sore) and TENDERNESS (Tender) had resolved. On 01-Mar-2021, FATIGUE (Tired) had resolved. At the time of the report, INJECTION SITE PRURITUS (Arm started to itch on the same place they got the vaccine), INJECTION SITE ERYTHEMA (Red spot), INJECTION SITE MASS (Hard lump), INJECTION SITE SWELLING (Little swollen), INJECTION SITE WARMTH (Warm  to the touch) and BACK PAIN (Little back ache) 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.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Injection site swelling, Injection site warmth, Tenderness
Clinical narrative: Arm started to itch on the same place they got the vaccine; Red spot; Hard lump; Little swollen; Warm  to the touch; Little back ache; Some redness that spread a little; Was a little sore; Tender; Tired; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of INJECTION SITE ERYTHEMA (Some redness that spread a little), INJECTION SITE PAIN (Was a little sore), TENDERNESS (Tender), FATIGUE (Tired) and INJECTION SITE PRURITUS (Arm started to itch on the same place they got the vaccine) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included MONTELUKAST for Allergy, ACETYLSALICYLIC ACID (BABY ASPIRIN), SERTRALINE and VITAMINS NOS for an unknown indication.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced INJECTION SITE ERYTHEMA (Some redness that spread a little), INJECTION SITE PAIN (Was a little sore), TENDERNESS (Tender) and FATIGUE (Tired). On 04-Mar-2021, the patient experienced INJECTION SITE PRURITUS (Arm started to itch on the same place they got the vaccine), INJECTION SITE ERYTHEMA (Red spot), INJECTION SITE MASS (Hard lump), INJECTION SITE SWELLING (Little swollen), INJECTION SITE WARMTH (Warm  to the touch) and BACK PAIN (Little back ache). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE, PARACETAMOL (TYLENOL PM) for Adverse event, at an unspecified dose and frequency. On 28-Feb-2021, INJECTION SITE ERYTHEMA (Some redness that spread a little), INJECTION SITE PAIN (Was a little sore) and TENDERNESS (Tender) had resolved. On 01-Mar-2021, FATIGUE (Tired) had resolved. At the time of the report, INJECTION SITE PRURITUS (Arm started to itch on the same place they got the vaccine), INJECTION SITE ERYTHEMA (Red spot), INJECTION SITE MASS (Hard lump), INJECTION SITE SWELLING (Little swollen), INJECTION SITE WARMTH (Warm  to the touch) and BACK PAIN (Little back ache) 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.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Hypersensitivity, Throat irritation
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of DYSPNOEA (Shortness of breath), THROAT IRRITATION (Scratchy throat) and HYPERSENSITIVITY (Hypersensitivity reaction) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma, Obesity, Penicillin allergy, Shellfish allergy and Oil allergy (Grape seed oil allergy.). Concomitant products included PREDNISONE for Asthma.    On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Mar-2021, the patient experienced DYSPNOEA (Shortness of breath), THROAT IRRITATION (Scratchy throat) and HYPERSENSITIVITY (Hypersensitivity reaction). At the time of the report, DYSPNOEA (Shortness of breath), THROAT IRRITATION (Scratchy throat) and HYPERSENSITIVITY (Hypersensitivity reaction) 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 activities for event was done with diphenhydramine (Benadryl) 25 mg oral and was monitored by an onsite nurse for 30 minutes. Patient felt better and was sent home.   Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: hypersensitivity form- Add medical history, allergies.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination error
Clinical narrative: First vaccinated with Pfizer's vaccine and second vaccine was Moderna's; A spontaneous report was received from a consumer concerning 63- years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and first vaccinated with Pfizer's vaccine and second vaccine was Moderna's/wrong product administered.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 26 Feb 2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (batch number: 010A21A) for prophylaxis of COVID-19 infection.  The patient was first vaccinated with Pfizer's vaccine on 05Feb2021 and second vaccine was Moderna's on 26 Feb 2021. The patient did not experience any reactions.  The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in response to the events was not applicable.  The outcome of the event first vaccinated with Pfizer's vaccine and second vaccine was Moderna's was considered recovered on 26 Feb 2021.  Follow-ups received on 24 Mar 2021 and 25 Mar 2021 included no new information.; Reporter's Comments: This report refers to a case of wrong vaccine administered for mRNA-1273.  There were no reported adverse events associated with this case.