chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: she woke up with "covid arm"; she also had hives all over her body; feeling itchy; a big rash at the injection site that it's getting better; body ache; Nausea; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body ache), PAIN IN EXTREMITY (she woke up with "covid arm"), URTICARIA (she also had hives all over her body), PRURITUS (feeling itchy) and NAUSEA (Nausea) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy, Peanut allergy, Fruit allergy (fresh fruit.) and Allergy to nuts (tree nut.).    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced PAIN (body ache), NAUSEA (Nausea) and FATIGUE (Fatigue). On 20-Mar-2021, the patient experienced PAIN IN EXTREMITY (she woke up with "covid arm"), URTICARIA (she also had hives all over her body), PRURITUS (feeling itchy) and RASH (a big rash at the injection site that it's getting better). On 15-Mar-2021, PAIN (body ache) outcome was unknown, NAUSEA (Nausea) and FATIGUE (Fatigue) had resolved. At the time of the report, PAIN IN EXTREMITY (she woke up with "covid arm") had resolved and URTICARIA (she also had hives all over her body), PRURITUS (feeling itchy) and RASH (a big rash at the injection site that it's getting better) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       treatment include topical Benadryl. No other medication reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-119837 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: the follow up were received on 11-MAY-2021 , the patient details were updated, relevant history was updated , event outcome updated; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-119837:First dose case
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Hypoaesthesia oral
Clinical narrative: tongue became numb; lip became numb; right hand became numb; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA ORAL (tongue became numb), HYPOAESTHESIA ORAL (lip became numb) and HYPOAESTHESIA (right hand became numb) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced HYPOAESTHESIA ORAL (tongue became numb), HYPOAESTHESIA ORAL (lip became numb) and HYPOAESTHESIA (right hand became numb). On 22-Mar-2021, HYPOAESTHESIA ORAL (tongue became numb), HYPOAESTHESIA ORAL (lip became numb) and HYPOAESTHESIA (right hand became numb) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitants products were reported. No treatment information was provided.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: red, hot, and itchy area around injection site- size of a grapefruit; red, hot, and itchy area around injection site- size of a grapefruit; red, hot, and itchy area around injection site- size of a grapefruit; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (red, hot, and itchy area around injection site- size of a grapefruit), VACCINATION SITE PRURITUS (red, hot, and itchy area around injection site- size of a grapefruit) and VACCINATION SITE ERYTHEMA (red, hot, and itchy area around injection site- size of a grapefruit) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included DILTIAZEM for an unknown indication.   On 12-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, the patient experienced VACCINATION SITE WARMTH (red, hot, and itchy area around injection site- size of a grapefruit), VACCINATION SITE PRURITUS (red, hot, and itchy area around injection site- size of a grapefruit) and VACCINATION SITE ERYTHEMA (red, hot, and itchy area around injection site- size of a grapefruit). On 20-Mar-2021, VACCINATION SITE WARMTH (red, hot, and itchy area around injection site- size of a grapefruit), VACCINATION SITE PRURITUS (red, hot, and itchy area around injection site- size of a grapefruit) and VACCINATION SITE ERYTHEMA (red, hot, and itchy area around injection site- size of a grapefruit) had resolved.            Treatment for events included ice. Action taken with mRNA-1273 in response to the event was not applicable.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Female orgasmic disorder, Lip blister, Nervous system disorder
Clinical narrative: central nervous system is buzzing throughout her whole body; feels as she is having a consent orgasm in her private area; blisters surrounding her lip area; fever of 102.5; chills; vomiting; This spontaneous case was reported by a consumer and describes the occurrence of NERVOUS SYSTEM DISORDER (central nervous system is buzzing throughout her whole body), FEMALE ORGASMIC DISORDER (feels as she is having a consent orgasm in her private area), LIP BLISTER (blisters surrounding her lip area), PYREXIA (fever of 102.5) and CHILLS (chills) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in October 2020. Concurrent medical conditions included Trigeminal neuralgia, Drug allergy and Anesthesia. Concomitant products included LISINOPRIL from 15-Jan-2015 to an unknown date, METOPROLOL from 15-Jan-2015 to an unknown date and ALPRAZOLAM from 15-Jan-2015 to an unknown date for Blood pressure high, AMLODIPINE for an unknown indication.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced LIP BLISTER (blisters surrounding her lip area), PYREXIA (fever of 102.5), CHILLS (chills) and VOMITING (vomiting). On 23-Mar-2021, the patient experienced NERVOUS SYSTEM DISORDER (central nervous system is buzzing throughout her whole body) and FEMALE ORGASMIC DISORDER (feels as she is having a consent orgasm in her private area). The patient was treated with PARACETAMOL (TYLENOL) for Symptomatic treatment, at an unspecified dose and frequency. On 22-Mar-2021, LIP BLISTER (blisters surrounding her lip area), PYREXIA (fever of 102.5), CHILLS (chills) and VOMITING (vomiting) had resolved. At the time of the report, NERVOUS SYSTEM DISORDER (central nervous system is buzzing throughout her whole body) had not resolved and FEMALE ORGASMIC DISORDER (feels as she is having a consent orgasm in her private area) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102.5 (High) 102.5 fever.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: Patient demographics, medical history added. Events, concomitant medication  updated.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: central nervous system is buzzing throughout her whole body; feels as she is having a consent orgasm in her private area; blisters surrounding her lip area; fever of 102.5; chills; vomiting; This spontaneous case was reported by a consumer and describes the occurrence of NERVOUS SYSTEM DISORDER (central nervous system is buzzing throughout her whole body), FEMALE ORGASMIC DISORDER (feels as she is having a consent orgasm in her private area), LIP BLISTER (blisters surrounding her lip area), PYREXIA (fever of 102.5) and CHILLS (chills) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in October 2020. Concurrent medical conditions included Trigeminal neuralgia, Drug allergy and Anesthesia. Concomitant products included LISINOPRIL from 15-Jan-2015 to an unknown date, METOPROLOL from 15-Jan-2015 to an unknown date and ALPRAZOLAM from 15-Jan-2015 to an unknown date for Blood pressure high, AMLODIPINE for an unknown indication.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced LIP BLISTER (blisters surrounding her lip area), PYREXIA (fever of 102.5), CHILLS (chills) and VOMITING (vomiting). On 23-Mar-2021, the patient experienced NERVOUS SYSTEM DISORDER (central nervous system is buzzing throughout her whole body) and FEMALE ORGASMIC DISORDER (feels as she is having a consent orgasm in her private area). The patient was treated with PARACETAMOL (TYLENOL) for Symptomatic treatment, at an unspecified dose and frequency. On 22-Mar-2021, LIP BLISTER (blisters surrounding her lip area), PYREXIA (fever of 102.5), CHILLS (chills) and VOMITING (vomiting) had resolved. At the time of the report, NERVOUS SYSTEM DISORDER (central nervous system is buzzing throughout her whole body) had not resolved and FEMALE ORGASMIC DISORDER (feels as she is having a consent orgasm in her private area) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102.5 (High) 102.5 fever.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: Patient demographics, medical history added. Events, concomitant medication  updated.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Ocular hyperaemia, Rash, Vaccination site discolouration, Vaccination site pain
Clinical narrative: Eyes were red; Blue injection site; elbows to her wrists was red (no rash or itchiness); Broke out on her neck(It was scaly); Injection site hurts; This spontaneous case was reported by a consumer and describes the occurrence of OCULAR HYPERAEMIA (Eyes were red), VACCINATION SITE DISCOLOURATION (Blue injection site), ERYTHEMA (elbows to her wrists was red (no rash or itchiness)), RASH (Broke out on her neck(It was scaly)) and VACCINATION SITE PAIN (Injection site hurts) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, the patient experienced OCULAR HYPERAEMIA (Eyes were red), VACCINATION SITE DISCOLOURATION (Blue injection site), ERYTHEMA (elbows to her wrists was red (no rash or itchiness)), RASH (Broke out on her neck(It was scaly)) and VACCINATION SITE PAIN (Injection site hurts). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, OCULAR HYPERAEMIA (Eyes were red), VACCINATION SITE DISCOLOURATION (Blue injection site), ERYTHEMA (elbows to her wrists was red (no rash or itchiness)), RASH (Broke out on her neck(It was scaly)) and VACCINATION SITE PAIN (Injection site hurts) outcome was unknown.            Concomitant product use was not provided by the reporter.     Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: TCR has information of events after first dose.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram head, Electroencephalogram, Extra dose administered, Magnetic resonance imaging head
Clinical narrative: Extra syringe from yesterday administered today; This spontaneous case was reported by a nurse and describes the occurrence of EXTRA DOSE ADMINISTERED (Extra syringe from yesterday administered today) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     Family history included Seizure (mother and sister). Concomitant products included ACETAMINOPHEN for Pain, LEVETIRACETAM (KEPPRA [LEVETIRACETAM]) for Seizure, KETOCONAZOLE (NIZORAL) for an unknown indication.    On 23-Mar-2021 at 8:48 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021 at 8:48 AM, the patient experienced EXTRA DOSE ADMINISTERED (Extra syringe from yesterday administered today). On 23-Mar-2021, EXTRA DOSE ADMINISTERED (Extra syringe from yesterday administered today) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram head: unknown (Inconclusive) unknown. On an unknown date, Electroencephalogram: normal (normal) normal. On an unknown date, Magnetic resonance imaging head: unknown (Inconclusive) mild cerebellar atrophy and incidental finding of Dandy-Walker Varient on MRi..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered EXTRA DOSE ADMINISTERED (Extra syringe from yesterday administered today) to be not related.    Patient had onset of  seizure on 25 Feb 2021 .  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: Follow up received on 24-may-2021, contains no new information. On 07-Jun-2021: Follow-up received on 07-Jun-2021. Patient datails were updated. Added event start date. Added Vaccine information.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Influenza like illness, Myalgia, Nausea
Clinical narrative: sore; all the flu-like symptoms; fever; body aches; headache; chills; nausea; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (sore), INFLUENZA LIKE ILLNESS (all the flu-like symptoms), PYREXIA (fever), MYALGIA (body aches) and HEADACHE (headache) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in 2020.    On 24-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN (sore), INFLUENZA LIKE ILLNESS (all the flu-like symptoms), PYREXIA (fever), MYALGIA (body aches), HEADACHE (headache), CHILLS (chills) and NAUSEA (nausea). At the time of the report, PAIN (sore), INFLUENZA LIKE ILLNESS (all the flu-like symptoms), PYREXIA (fever), MYALGIA (body aches), HEADACHE (headache), CHILLS (chills) and NAUSEA (nausea) 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. No treatment information was provided.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: sore; all the flu-like symptoms; fever; body aches; headache; chills; nausea; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (sore), INFLUENZA LIKE ILLNESS (all the flu-like symptoms), PYREXIA (fever), MYALGIA (body aches) and HEADACHE (headache) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in 2020.    On 24-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN (sore), INFLUENZA LIKE ILLNESS (all the flu-like symptoms), PYREXIA (fever), MYALGIA (body aches), HEADACHE (headache), CHILLS (chills) and NAUSEA (nausea). At the time of the report, PAIN (sore), INFLUENZA LIKE ILLNESS (all the flu-like symptoms), PYREXIA (fever), MYALGIA (body aches), HEADACHE (headache), CHILLS (chills) and NAUSEA (nausea) 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. No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Vaccination site pruritus
Clinical narrative: Itching in arms, neck, stomach; Itching at injection site; This spontaneous case was reported by a nurse and describes the occurrence of PRURITUS (Itching in arms, neck, stomach) and VACCINATION SITE PRURITUS (Itching at injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Anaphylactic reaction to omega 3's in the past). Concomitant products included DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for an unknown indication.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRURITUS (Itching in arms, neck, stomach) and VACCINATION SITE PRURITUS (Itching at injection site). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Itching and Vaccination site pruritus, at an unspecified dose and frequency. At the time of the report, PRURITUS (Itching in arms, neck, stomach) and VACCINATION SITE PRURITUS (Itching at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant products were reported.   Reporter did not allow further contact
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: pain or soreness on the neck; little itchy; swollen; little soreness; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (pain or soreness on the neck), VACCINATION SITE PRURITUS (little itchy), VACCINATION SITE SWELLING (swollen) and VACCINATION SITE PAIN (little soreness) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     Concurrent medical conditions included Bell's palsy (Bell's Palsy on the right side of the face). Concomitant products included FINASTERIDE for an unknown indication.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced NECK PAIN (pain or soreness on the neck), VACCINATION SITE PRURITUS (little itchy), VACCINATION SITE SWELLING (swollen) and VACCINATION SITE PAIN (little soreness). At the time of the report, NECK PAIN (pain or soreness on the neck), VACCINATION SITE PRURITUS (little itchy), VACCINATION SITE SWELLING (swollen) and VACCINATION SITE PAIN (little soreness) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Other relevant concomitant medications included, Fenestra and Sterol lactone were reported.   Treatment information was not provided.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Patient only 17 years old (underage); interchange of vaccine product; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient only 17 years old (underage)) and WRONG PRODUCT ADMINISTERED (interchange of vaccine product) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient only 17 years old (underage)) and WRONG PRODUCT ADMINISTERED (interchange of vaccine product). On 01-Mar-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient only 17 years old (underage)) and WRONG PRODUCT ADMINISTERED (interchange of vaccine product) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: This report refers to a case of Wrong product administered and product administered to patient of inappropriate age (17 year old) for mRNA-1273 (lot number unknown) with no associated AEs.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore 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 25-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 PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitants products were reported.No treatment information was provided.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives all over her body; This spontaneous case was reported by a health care professional and describes the occurrence of URTICARIA (Hives all over her body) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced URTICARIA (Hives all over her body). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of UNK, qhs. At the time of the report, URTICARIA (Hives all over her body) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitants products were reported.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Throat irritation
Clinical narrative: constantly coughing; throat is itching; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (constantly coughing) and THROAT IRRITATION (throat is itching) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Asthma. Concomitant products included FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]), ASPIRIN [ACETYLSALICYLIC ACID], ALENDRONATE SODIUM (ALENDRONATE), MONTELUKAST, DICLOFENAC and LORATADINE for an unknown indication.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COUGH (constantly coughing) and THROAT IRRITATION (throat is itching). At the time of the report, COUGH (constantly coughing) and THROAT IRRITATION (throat is itching) 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 assessment.  Treatment information was not provided.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Palpitations
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (racing of her heart/beating loudly) and FEELING ABNORMAL (felt like it was going to come out of her chest) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PALPITATIONS (racing of her heart/beating loudly) and FEELING ABNORMAL (felt like it was going to come out of her chest). At the time of the report, PALPITATIONS (racing of her heart/beating loudly) and FEELING ABNORMAL (felt like it was going to come out of her chest) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Additional information received on 10-May-2021 contain no new information.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Induration, Peripheral swelling
Clinical narrative: swelling on the left arm; Hardness; Redness; This spontaneous case was reported by an other health care professional and describes the occurrence of PERIPHERAL SWELLING (swelling on the left arm), INDURATION (Hardness) and ERYTHEMA (Redness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (swelling on the left arm), INDURATION (Hardness) and ERYTHEMA (Redness). At the time of the report, PERIPHERAL SWELLING (swelling on the left arm), INDURATION (Hardness) and ERYTHEMA (Redness) 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 drugs were not provided concomitant drugs were not provided.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Coronavirus test positive
Clinical narrative: Tested positive for covid -19; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of CORONAVIRUS TEST POSITIVE (Tested positive for covid -19) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced CORONAVIRUS TEST POSITIVE (Tested positive for covid -19). At the time of the report, CORONAVIRUS TEST POSITIVE (Tested positive for covid -19) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Feb-2021, Coronavirus test positive: 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.   Concominant medication were not reported. Treatment information was not provided.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Diarrhoea, Electrocardiogram, Presyncope, Product administration interrupted
Clinical narrative: It has been 38 days since she received first dose and does not have second dose scheduled yet due to availability; It has been 38 days since she received first dose and does not have second dose scheduled yet due to availability; felt like she was going to pass out; spontaneous diarrhea; arm pains in same arm of injection; chest pains; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (chest pains), PRESYNCOPE (felt like she was going to pass out), DIARRHOEA (spontaneous diarrhea), PRODUCT ADMINISTRATION INTERRUPTED (It has been 38 days since she received first dose and does not have second dose scheduled yet due to availability) and PRODUCT AVAILABILITY ISSUE (It has been 38 days since she received first dose and does not have second dose scheduled yet due to availability) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included CARVEDILOL (COREG), RAMIPRIL (ALTACE), ROSUVASTATIN and VITAMINS NOS for an unknown indication.    On 08-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 CHEST PAIN (chest pains) and VACCINATION SITE PAIN (arm pains in same arm of injection). On 05-Mar-2021, the patient experienced PRESYNCOPE (felt like she was going to pass out) and DIARRHOEA (spontaneous diarrhea). On an unknown date, the patient experienced PRODUCT ADMINISTRATION INTERRUPTED (It has been 38 days since she received first dose and does not have second dose scheduled yet due to availability) and PRODUCT AVAILABILITY ISSUE (It has been 38 days since she received first dose and does not have second dose scheduled yet due to availability). On 05-Mar-2021, CHEST PAIN (chest pains), PRESYNCOPE (felt like she was going to pass out), DIARRHOEA (spontaneous diarrhea) and VACCINATION SITE PAIN (arm pains in same arm of injection) had resolved. At the time of the report, PRODUCT ADMINISTRATION INTERRUPTED (It has been 38 days since she received first dose and does not have second dose scheduled yet due to availability) and PRODUCT AVAILABILITY ISSUE (It has been 38 days since she received first dose and does not have second dose scheduled yet due to availability) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Electrocardiogram: normal (normal) normal. On an unknown date, Urine analysis: normal (normal) normal. On an unknown date, X-ray: normal (normal) normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was reported.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Product availability issue, Urine analysis, Vaccination site pain, X-ray
Clinical narrative: It has been 38 days since she received first dose and does not have second dose scheduled yet due to availability; It has been 38 days since she received first dose and does not have second dose scheduled yet due to availability; felt like she was going to pass out; spontaneous diarrhea; arm pains in same arm of injection; chest pains; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (chest pains), PRESYNCOPE (felt like she was going to pass out), DIARRHOEA (spontaneous diarrhea), PRODUCT ADMINISTRATION INTERRUPTED (It has been 38 days since she received first dose and does not have second dose scheduled yet due to availability) and PRODUCT AVAILABILITY ISSUE (It has been 38 days since she received first dose and does not have second dose scheduled yet due to availability) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included CARVEDILOL (COREG), RAMIPRIL (ALTACE), ROSUVASTATIN and VITAMINS NOS for an unknown indication.    On 08-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 CHEST PAIN (chest pains) and VACCINATION SITE PAIN (arm pains in same arm of injection). On 05-Mar-2021, the patient experienced PRESYNCOPE (felt like she was going to pass out) and DIARRHOEA (spontaneous diarrhea). On an unknown date, the patient experienced PRODUCT ADMINISTRATION INTERRUPTED (It has been 38 days since she received first dose and does not have second dose scheduled yet due to availability) and PRODUCT AVAILABILITY ISSUE (It has been 38 days since she received first dose and does not have second dose scheduled yet due to availability). On 05-Mar-2021, CHEST PAIN (chest pains), PRESYNCOPE (felt like she was going to pass out), DIARRHOEA (spontaneous diarrhea) and VACCINATION SITE PAIN (arm pains in same arm of injection) had resolved. At the time of the report, PRODUCT ADMINISTRATION INTERRUPTED (It has been 38 days since she received first dose and does not have second dose scheduled yet due to availability) and PRODUCT AVAILABILITY ISSUE (It has been 38 days since she received first dose and does not have second dose scheduled yet due to availability) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Electrocardiogram: normal (normal) normal. On an unknown date, Urine analysis: normal (normal) normal. On an unknown date, X-ray: normal (normal) normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was reported.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Dysphonia
Clinical narrative: hoarse throat/her voice is going; COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) and DYSPHONIA (hoarse throat) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     Concomitant products included MONTELUKAST, FAMOTIDINE, PRAVASTATIN, OMEPRAZOLE and HYDROCHLOROTHIAZIDE 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 07-Mar-2021, the patient experienced COVID-19 (COVID-19). On an unknown date, the patient experienced DYSPHONIA (hoarse throat). At the time of the report, COVID-19 (COVID-19) and DYSPHONIA (hoarse throat) 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.   No treatment products reported.   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Follow up information was received on 10 May 2021 wherein event hoarse voice was added.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Dental discomfort
Clinical narrative: tooth issue; This spontaneous case was reported by a consumer and describes the occurrence of DENTAL DISCOMFORT (tooth issue) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DENTAL DISCOMFORT (tooth issue). At the time of the report, DENTAL DISCOMFORT (tooth issue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant information were not provided. Treatment information were not provided.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Itchiness; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchiness) 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-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced PRURITUS (Itchiness). At the time of the report, PRURITUS (Itchiness) 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.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Migraine, Nasopharyngitis, Pyrexia
Clinical narrative: Cold; Migraine; High fever 103F; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Cold), MIGRAINE (Migraine) and PYREXIA (High fever 103F) in an 18-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced MIGRAINE (Migraine) and PYREXIA (High fever 103F). On 16-Mar-2021, the patient experienced NASOPHARYNGITIS (Cold). On 06-Mar-2021, MIGRAINE (Migraine) and PYREXIA (High fever 103F) had resolved. At the time of the report, NASOPHARYNGITIS (Cold) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Mar-2021, Body temperature: 103 (High) 103F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication use was provided by the reporter.  No treatment of events was reported.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Pregnancy test, Ultrasound foetal
Clinical narrative: 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 26-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     The patient's past medical history included Miscarriage in June 2020. Concurrent medical conditions included Asthma (Using an inhaler). Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for Pregnancy, DOCUSATE SODIUM (COLACE) for an unknown indication.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 20-Nov-2020 and the estimated date of delivery was 29-Aug-2021. On 23-Mar-2021, the patient experienced EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  seventeenth week of the pregnancy.  On 23-Mar-2021, EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Dec-2020, Pregnancy test: positive (Positive) Positive. On an unknown date, Ultrasound foetal: normal (normal) normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Other concomitant product was an inhaler for Asthma.  No treatment information was reported.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: her arm started itching,; arm turned red; arm was a bit swollen; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), PRURITUS (her arm started itching,), ERYTHEMA (arm turned red) and PERIPHERAL SWELLING (arm was a bit swollen) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 20-Mar-2021, the patient experienced PRURITUS (her arm started itching,), ERYTHEMA (arm turned red) and PERIPHERAL SWELLING (arm was a bit swollen). At the time of the report, PAIN IN EXTREMITY (Sore arm), PRURITUS (her arm started itching,), ERYTHEMA (arm turned red) and PERIPHERAL SWELLING (arm was a bit swollen) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No contaminant products were reported. No treatment information was reported.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle strain, Pain in extremity, Skin discolouration, Vaccination site pain, Vaccination site pruritus
Clinical narrative: Muscle tug; Large medium dark pink area; Itching at the injection site; Pain at the injection site; Pain in the area, in the upper part of her left arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in the area, in the upper part of her left arm), SKIN DISCOLOURATION (Large medium dark pink area), MUSCLE STRAIN (Muscle tug), VACCINATION SITE PRURITUS (Itching at the injection site) and VACCINATION SITE PAIN (Pain at the injection site) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 04821A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ATORVASTATIN CALCIUM (LIPITOR) from 19-Feb-2021 to an unknown date for Osteoporosis, RISEDRONATE SODIUM (RISEDRONATE), COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) and CALCIUM for an unknown indication.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced PAIN IN EXTREMITY (Pain in the area, in the upper part of her left arm). On 19-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (Itching at the injection site) and VACCINATION SITE PAIN (Pain at the injection site). On 20-Mar-2021, the patient experienced SKIN DISCOLOURATION (Large medium dark pink area). On 22-Mar-2021, the patient experienced MUSCLE STRAIN (Muscle tug). The patient was treated with HYDROCORTISONE (HYDROCORTISON AL) for Itching, at a dose of 1 % hydrocortisone used only once. On 22-Mar-2021, SKIN DISCOLOURATION (Large medium dark pink area) and VACCINATION SITE PRURITUS (Itching at the injection site) had resolved, VACCINATION SITE PAIN (Pain at the injection site) outcome was unknown. At the time of the report, PAIN IN EXTREMITY (Pain in the area, in the upper part of her left arm) had resolved and MUSCLE STRAIN (Muscle tug) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments.  Patient had a large medium dark pink area and it was so big 4 inches wide x 2 inches side to side.  On 21FEB2020, size was 3 1/2 by 1 1/2.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Induration, Myalgia, Pruritus, Rash
Clinical narrative: hardness; itching in arm; rash; soreness; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of INDURATION (hardness), PRURITUS (itching in arm), RASH (rash), MYALGIA (soreness) and FATIGUE (fatigue) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for an unknown indication.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, the patient experienced INDURATION (hardness), PRURITUS (itching in arm), RASH (rash), MYALGIA (soreness) and FATIGUE (fatigue). At the time of the report, INDURATION (hardness), PRURITUS (itching in arm), RASH (rash), MYALGIA (soreness) and FATIGUE (fatigue) 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.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: she began having diarrhea and still has diarrhea to this day.; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (she began having diarrhea and still has diarrhea to this day.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included OXYCODONE for an unknown indication.   On 10-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, the patient experienced DIARRHOEA (she began having diarrhea and still has diarrhea to this day.). At the time of the report, DIARRHOEA (she began having diarrhea and still has diarrhea to this day.) had not resolved.            Treatment medication include over the counter anti-diarrhea pills.  Action taken with mRNA-1273 in response to event was not applicable.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle twitching
Clinical narrative: twitching on right arm/ left side of face; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE TWITCHING (twitching on right arm/ left side of face) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced MUSCLE TWITCHING (twitching on right arm/ left side of face). On 19-Mar-2021, MUSCLE TWITCHING (twitching on right arm/ left side of face) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitants products were reported. No treatment information was provided.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Gynaecomastia
Clinical narrative: Enlarge breast (gynecomastia); This spontaneous case was reported by a health care professional and describes the occurrence of GYNAECOMASTIA (Enlarge breast (gynecomastia)) 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 17-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Mar-2021, the patient experienced GYNAECOMASTIA (Enlarge breast (gynecomastia)). At the time of the report, GYNAECOMASTIA (Enlarge breast (gynecomastia)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Treatment information was not provided.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable