chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Abdominal discomfort, Diarrhoea
Clinical narrative: long term stomach sensitivity /; Diarrhea; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 28-Jun-2021 and was forwarded to Moderna on 28-Jun-2021.    This spontaneous case was reported by a patient and describes the occurrence of ABDOMINAL DISCOMFORT (long term stomach sensitivity /) and DIARRHOEA (Diarrhea) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ABDOMINAL DISCOMFORT (long term stomach sensitivity /) and DIARRHOEA (Diarrhea). At the time of the report, ABDOMINAL DISCOMFORT (long term stomach sensitivity /) and DIARRHOEA (Diarrhea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication use was unknown Treatment information was unknown
Sex: U
Vaccine: COVID19
Symptoms: Asthma, Bronchitis
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of bronchitis (diagnosed last week) and bronchial asthma in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced bronchitis (diagnosed last week) and bronchial asthma. At the time of the report,  bronchitis (diagnosed last week) and bronchial asthma outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant medication details reported. Treatment included 2 antibiotics and steroids.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Arm that got the shot has been feeling sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN ( Arm that got the shot has been feeling sore) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Jun-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 27-Jun-2021, the patient experienced VACCINATION SITE PAIN ( Arm that got the shot has been feeling sore). At the time of the report, VACCINATION SITE PAIN ( Arm that got the shot has been feeling sore) outcome was unknown.            No concomitant medications was reported by the reporter No treatment medications was  provided by the reporter.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Hypoaesthesia, Impaired work ability, Insomnia, Loss of personal independence in daily activities, Paraesthesia
Clinical narrative: Tingling through my whole body; Numbness through my whole body; It affected my sleep; It affected my work; it affected my daily activities; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Tingling through my whole body), HYPOAESTHESIA (Numbness through my whole body), INSOMNIA (It affected my sleep), IMPAIRED WORK ABILITY (It affected my work) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (it affected my daily activities) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage form. On an unknown date, the patient experienced PARAESTHESIA (Tingling through my whole body), HYPOAESTHESIA (Numbness through my whole body), INSOMNIA (It affected my sleep), IMPAIRED WORK ABILITY (It affected my work) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (it affected my daily activities). At the time of the report, PARAESTHESIA (Tingling through my whole body), HYPOAESTHESIA (Numbness through my whole body), INSOMNIA (It affected my sleep), IMPAIRED WORK ABILITY (It affected my work) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (it affected my daily activities) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications  were reported. No Treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Missed 2nd dose.; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed 2nd dose.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed 2nd dose.). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed 2nd dose.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported. No treatment medication was reported.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Patient got 1st dose on 10 May 2021, and wants 2nd shot today 28jun2021; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient got 1st dose on 10 May 2021, and wants 2nd shot today 28jun2021) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-May-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient got 1st dose on 10 May 2021, and wants 2nd shot today 28Jun2021). On 10-May-2021, PRODUCT DOSE OMISSION ISSUE (Patient got 1st dose on 10 May 2021, and wants 2nd shot today 28jun2021) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant and treatment medications were provided.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Discomfort, Menstrual disorder, Menstruation delayed, Pain in extremity
Clinical narrative: She was uncomfortable in bed because of this; Delay of 3 days in her period; Next period suffer a change in flow (lower than usual); Fever of 38.4°C; Strong pain in her arm; This spontaneous case was reported by a consumer and describes the occurrence of DISCOMFORT (She was uncomfortable in bed because of this), MENSTRUATION DELAYED (Delay of 3 days in her period), PAIN IN EXTREMITY (Strong pain in her arm), MENSTRUAL DISORDER (Next period suffer a change in flow (lower than usual)) and PYREXIA (Fever of 38.4°C) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 054C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Jun-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 27-Jun-2021, the patient experienced PAIN IN EXTREMITY (Strong pain in her arm). On 28-Jun-2021, the patient experienced PYREXIA (Fever of 38.4°C). On an unknown date, the patient experienced DISCOMFORT (She was uncomfortable in bed because of this), MENSTRUATION DELAYED (Delay of 3 days in her period) and MENSTRUAL DISORDER (Next period suffer a change in flow (lower than usual)). The patient was treated with IBUPROFEN ongoing since an unknown date for Fever, at an unspecified dose and frequency. On 28-Jun-2021, PYREXIA (Fever of 38.4°C) had resolved. At the time of the report, DISCOMFORT (She was uncomfortable in bed because of this), MENSTRUATION DELAYED (Delay of 3 days in her period), PAIN IN EXTREMITY (Strong pain in her arm) and MENSTRUAL DISORDER (Next period suffer a change in flow (lower than usual)) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Jun-2021, Body temperature: 38.4 (High) 38.4°C, 37.4°c (High) 37.4°C and 37°c (normal) 37°C.         Concomitant medication included birth control pills.  Patient reported that all symptoms faded in a couple of days as normal identified side effects.   This case was linked to MOD-2021-187591 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 24-Jul-2021: Outcome of event was updated to resolved and event of menstrual disorder added. lab data updated from initial source.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: She was uncomfortable in bed because of this; Delay of 3 days in her period; Next period suffer a change in flow (lower than usual); Fever of 38.4°C; Strong pain in her arm; This spontaneous case was reported by a consumer and describes the occurrence of DISCOMFORT (She was uncomfortable in bed because of this), MENSTRUATION DELAYED (Delay of 3 days in her period), PAIN IN EXTREMITY (Strong pain in her arm), MENSTRUAL DISORDER (Next period suffer a change in flow (lower than usual)) and PYREXIA (Fever of 38.4°C) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 054C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Jun-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 27-Jun-2021, the patient experienced PAIN IN EXTREMITY (Strong pain in her arm). On 28-Jun-2021, the patient experienced PYREXIA (Fever of 38.4°C). On an unknown date, the patient experienced DISCOMFORT (She was uncomfortable in bed because of this), MENSTRUATION DELAYED (Delay of 3 days in her period) and MENSTRUAL DISORDER (Next period suffer a change in flow (lower than usual)). The patient was treated with IBUPROFEN ongoing since an unknown date for Fever, at an unspecified dose and frequency. On 28-Jun-2021, PYREXIA (Fever of 38.4°C) had resolved. At the time of the report, DISCOMFORT (She was uncomfortable in bed because of this), MENSTRUATION DELAYED (Delay of 3 days in her period), PAIN IN EXTREMITY (Strong pain in her arm) and MENSTRUAL DISORDER (Next period suffer a change in flow (lower than usual)) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Jun-2021, Body temperature: 38.4 (High) 38.4°C, 37.4°c (High) 37.4°C and 37°c (normal) 37°C.         Concomitant medication included birth control pills.  Patient reported that all symptoms faded in a couple of days as normal identified side effects.   This case was linked to MOD-2021-187591 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 24-Jul-2021: Outcome of event was updated to resolved and event of menstrual disorder added. lab data updated from initial source.
Sex: U
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: Consumer answered "Yes" when asked if they had received the Moderna COVID-19 and experienced a side effect; This spontaneous case was reported by a consumer and describes the occurrence of UNEVALUABLE EVENT (Consumer answered "Yes" when asked if they had received the Moderna COVID-19 and experienced a side effect) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced UNEVALUABLE EVENT (Consumer answered "Yes" when asked if they had received the Moderna COVID-19 and experienced a side effect). At the time of the report, UNEVALUABLE EVENT (Consumer answered "Yes" when if they had received the Moderna COVID-19 and experienced a side effect) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported. No treatment information was provided.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Lip swelling, Pain in extremity
Clinical narrative: Brain fog; Swelling of Lips; Headache; Sore Arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore Arm), FEELING ABNORMAL (Brain fog), LIP SWELLING (Swelling of Lips) and HEADACHE (Headache) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included BICTEGRAVIR SODIUM, EMTRICITABINE, TENOFOVIR ALAFENAMIDE FUMARATE (BIKTARVY) for an unknown indication.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (Sore Arm). On 28-Jun-2021, the patient experienced FEELING ABNORMAL (Brain fog), LIP SWELLING (Swelling of Lips) and HEADACHE (Headache). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form. At the time of the report, PAIN IN EXTREMITY (Sore Arm), FEELING ABNORMAL (Brain fog), LIP SWELLING (Swelling of Lips) and HEADACHE (Headache) outcome was unknown.            This case was linked to MOD-2021-238986 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Received the first dose on March 24, 2021, are they still eligible for the second dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Received the first dose on March 24, 2021, are they still eligible for the second dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Received the first dose on March 24, 2021, are they still eligible for the second dose). On 24-Mar-2021, PRODUCT DOSE OMISSION ISSUE (Received the first dose on March 24, 2021, are they still eligible for the second dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided by the reporter. Treatment information was not provided.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received his first dose of the Moderna Covid-19 vaccine as an expired vaccine.; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received his first dose of the Moderna Covid-19 vaccine as an expired vaccine.) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received his first dose of the Moderna Covid-19 vaccine as an expired vaccine.). On 21-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Patient received his first dose of the Moderna Covid-19 vaccine as an expired vaccine.) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication information were provided.  No treatment information was provided.  The vaccine was placed in the refrigerator on 20-May-2021. The vaccine expiration date was 19-Jun-2021. No Other Adverse Events were reported.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Shingles) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jun-2021, the patient experienced HERPES ZOSTER (Shingles). The patient was treated with ACYCLOVIR [ACICLOVIR] for Shingles, at an unspecified dose and frequency. At the time of the report, HERPES ZOSTER (Shingles) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided. Treatment information was not provided.    For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-239102, MOD-2021-239102.
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: first dose of the vaccine two months ago and missed my second dose appointment; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (first dose of the vaccine two months ago and missed my second dose appointment) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (first dose of the vaccine two months ago and missed my second dose appointment). At the time of the report, PRODUCT DOSE OMISSION ISSUE (first dose of the vaccine two months ago and missed my second dose appointment) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided by reporter. Treatment information was not provided by reporter.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Nasal congestion, Vaccination site pain
Clinical narrative: congestion; Soreness at the injection site on left arm; This spontaneous case was reported by a consumer and describes the occurrence of NASAL CONGESTION (congestion) and VACCINATION SITE PAIN (Soreness at the injection site on left arm) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025C0A) for COVID-19 vaccination.     The patient's past medical history included Surgery (artificial heart valve) and Dental surgery NOS (received amoxicillin on 23JUNE2021 prior to vaccine). Concomitant products included AMOXICILLIN for an unknown indication.    On 26-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jun-2021, the patient experienced NASAL CONGESTION (congestion) and VACCINATION SITE PAIN (Soreness at the injection site on left arm). The patient was treated with GUAIFENESIN (MUCINEX) ongoing since an unknown date for Rhinitis, at an unspecified dose and frequency. On 28-Jun-2021, VACCINATION SITE PAIN (Soreness at the injection site on left arm) had resolved. At the time of the report, NASAL CONGESTION (congestion) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient received amoxicillin on 23-JUN-2021 prior to vaccine for a dental procedure and consumed Mucinex 3 weeks ago for cold symptoms, which was unrelated to vaccine injection as symptoms appeared prior to injection.  It was reported that the patient got the second shot and was fine.  Treatment details were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: Follow up information received on 26-Jul-2021,  and received 2nd dose details, updated outcome of nasal congestion to resolved.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Product administered to patient of inappropriate age
Clinical narrative: 16 year old son got the Moderna Covid-19 Vaccine accidentally; sore arm; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old son got the Moderna Covid-19 Vaccine accidentally) and MYALGIA (sore arm) in a 16-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-May-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old son got the Moderna Covid-19 Vaccine accidentally). On an unknown date, the patient experienced MYALGIA (sore arm). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old son got the Moderna Covid-19 Vaccine accidentally) and MYALGIA (sore arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication not provided.  Treatment information not provided.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: mildly painful in my arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (mildly painful in my arm) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B1321A and 011D21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included VITAMIN B COMPLEX (B-COMPLEX [VITAMIN B COMPLEX]), VITAMIN D [VITAMIN D NOS], VITAMIN A [RETINOL], PROBIOTICS NOS and OMEGA-3 NOS for an unknown indication.   On 15-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jun-2021 at 10:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 16-May-2021, the patient experienced MYALGIA (mildly painful in my arm). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. At the time of the report, MYALGIA (mildly painful in my arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-239035 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: Covid Positve; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Covid Positve) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SARS-COV-2 TEST POSITIVE (Covid Positve). At the time of the report, SARS-COV-2 TEST POSITIVE (Covid Positve) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) SARS-CoV-2 test.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided by the reporter. .
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia
Clinical narrative: chills; headache; sore arm; This spontaneous case was reported by a non-health professional and describes the occurrence of CHILLS (chills), HEADACHE (headache) and MYALGIA (sore arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Medical history was not provided.     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 CHILLS (chills), HEADACHE (headache) and MYALGIA (sore arm). At the time of the report, CHILLS (chills), HEADACHE (headache) and MYALGIA (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication information was provided.   No treatment information was provided.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: mild symptoms after the first one / side effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (mild symptoms after the first one / side effects) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On an unknown date, the patient experienced VACCINATION COMPLICATION (mild symptoms after the first one / side effects). At the time of the report, VACCINATION COMPLICATION (mild symptoms after the first one / side effects) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) dosing remained unchanged.       Concomitant drug was not reported. Treatment medication was not reported.   This case was linked to MOD-2021-239046 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 01-Jul-2021: Follow up received on 01-JUL-2021 contains No new information (NNI)
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Vaccination site erythema
Clinical narrative: Bright red circle 2 inches in diameter where the shot was given; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Bright red circle 2 inches in diameter where the shot was given) and MYALGIA (Sore arm) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     No Medical History Information was Reported.     On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (Bright red circle 2 inches in diameter where the shot was given) and MYALGIA (Sore arm). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of 1 dosage form. At the time of the report, VACCINATION SITE ERYTHEMA (Bright red circle 2 inches in diameter where the shot was given) and MYALGIA (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medication Information was Reported Contact information was updated. Caller confirmed side effects previously reported. Some information was lost due to system crashing.   This case was linked to MOD-2021-067622 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Loss of personal independence in daily activities, Vaccination complication
Clinical narrative: Severe side effects & worse after the second one & i have blood / side effects; For the past 2 weeks unable to go to work & For the past 2 weeks I am unable to drive my car; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Severe side effects & worse after the second one & i have blood / side effects) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (For the past 2 weeks unable to go to work & For the past 2 weeks I am unable to drive my car) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Severe side effects & worse after the second one & i have blood / side effects) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (For the past 2 weeks unable to go to work & For the past 2 weeks I am unable to drive my car). At the time of the report, VACCINATION COMPLICATION (Severe side effects & worse after the second one & i have blood / side effects) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (For the past 2 weeks unable to go to work & For the past 2 weeks I am unable to drive my car) outcome was unknown.            No concomitant medications were provided.  No treatment medication were provided.   This case was linked to MOD-2021-239039.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 01-Jul-2021: Follow-up information received  contains non-significant information
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received dose after refrigerated expiry date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received dose after refrigerated expiry date) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received dose after refrigerated expiry date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received dose after refrigerated expiry date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Treatment information was unknown. Action taken with mRNA-1273 in response to the events was not applicable.
Sex: U
Vaccine: COVID19
Symptoms: Bronchitis, Cough, Erythema, Fatigue, Headache
Clinical narrative: Severe cough /Cough getting worse; Nights of sweat; like a bronchitis cough; swelling; redness on skin; fever / high temperature; tiredness; headache; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Severe cough /Cough getting worse), NIGHT SWEATS (Nights of sweat), BRONCHITIS (like a bronchitis cough), SWELLING (swelling) and ERYTHEMA (redness on skin) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 24-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COUGH (Severe cough /Cough getting worse), NIGHT SWEATS (Nights of sweat), BRONCHITIS (like a bronchitis cough), SWELLING (swelling), ERYTHEMA (redness on skin), PYREXIA (fever / high temperature), FATIGUE (tiredness) and HEADACHE (headache). At the time of the report, COUGH (Severe cough /Cough getting worse), NIGHT SWEATS (Nights of sweat), BRONCHITIS (like a bronchitis cough), SWELLING (swelling), ERYTHEMA (redness on skin), PYREXIA (fever / high temperature), FATIGUE (tiredness) and HEADACHE (headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: 105 (High) high heart rate of 105 when laying down.         No concomitant medications were reported.  No treatment medications were provided by the reporter.  On day 4 patient had no sweat at night   Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: follow-up was received and contains no significant information.
Sex: U
Vaccine: COVID19
Symptoms: Heart rate, Night sweats, Pyrexia, Swelling
Clinical narrative: Severe cough /Cough getting worse; Nights of sweat; like a bronchitis cough; swelling; redness on skin; fever / high temperature; tiredness; headache; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Severe cough /Cough getting worse), NIGHT SWEATS (Nights of sweat), BRONCHITIS (like a bronchitis cough), SWELLING (swelling) and ERYTHEMA (redness on skin) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 24-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COUGH (Severe cough /Cough getting worse), NIGHT SWEATS (Nights of sweat), BRONCHITIS (like a bronchitis cough), SWELLING (swelling), ERYTHEMA (redness on skin), PYREXIA (fever / high temperature), FATIGUE (tiredness) and HEADACHE (headache). At the time of the report, COUGH (Severe cough /Cough getting worse), NIGHT SWEATS (Nights of sweat), BRONCHITIS (like a bronchitis cough), SWELLING (swelling), ERYTHEMA (redness on skin), PYREXIA (fever / high temperature), FATIGUE (tiredness) and HEADACHE (headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: 105 (High) high heart rate of 105 when laying down.         No concomitant medications were reported.  No treatment medications were provided by the reporter.  On day 4 patient had no sweat at night   Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: follow-up was received and contains no significant information.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Essential tremor, Feelings of worthlessness, Pain in extremity
Clinical narrative: Severe leg on the right side; Maimed for life; Severe hip pain on the right side; Diagnosed with essential tremors; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Severe leg on the right side), ESSENTIAL TREMOR (Diagnosed with essential tremors), FEELINGS OF WORTHLESSNESS (Maimed for life) and ARTHRALGIA (Severe hip pain on the right side) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     No medical history was provided by reporter.  Concomitant products included MULTIVITAMIN [VITAMINS NOS] for an unknown indication.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jun-2021, the patient experienced ESSENTIAL TREMOR (Diagnosed with essential tremors). On an unknown date, the patient experienced PAIN IN EXTREMITY (Severe leg on the right side), FEELINGS OF WORTHLESSNESS (Maimed for life) and ARTHRALGIA (Severe hip pain on the right side). The patient was treated with PROPRANOLOL for Essential tremor, at a dose of 1 dosage form. At the time of the report, PAIN IN EXTREMITY (Severe leg on the right side), ESSENTIAL TREMOR (Diagnosed with essential tremors), FEELINGS OF WORTHLESSNESS (Maimed for life) and ARTHRALGIA (Severe hip pain on the right side) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Name of concomitant medications for seizure were denied by the patient.     This case was linked to MOD-2021-215104 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 09-Jul-2021: Follow-up information received on 09-JUL-2021 contains no new information.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received a Moderna COVID-19 vaccine dose from a 20 hours punctured vial; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received a Moderna COVID-19 vaccine dose from a 20 hours punctured vial) 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 26-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received a Moderna COVID-19 vaccine dose from a 20 hours punctured vial). On 26-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Patient received a Moderna COVID-19 vaccine dose from a 20 hours punctured vial) 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 concomitant medications were provided. Treatment medications were unknown.
Sex: U
Vaccine: COVID19
Symptoms: Discomfort, Fatigue, Headache, Vaccination site pain
Clinical narrative: some dicomfort for about 36 hrs; headache; fatigue; injection site soreness; This spontaneous case was reported by a consumer and describes the occurrence of DISCOMFORT (some dicomfort for about 36 hrs), HEADACHE (headache), FATIGUE (fatigue) and VACCINATION SITE PAIN (injection site soreness) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DISCOMFORT (some dicomfort for about 36 hrs), HEADACHE (headache), FATIGUE (fatigue) and VACCINATION SITE PAIN (injection site soreness). At the time of the report, DISCOMFORT (some dicomfort for about 36 hrs), HEADACHE (headache), FATIGUE (fatigue) and VACCINATION SITE PAIN (injection site soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product use was reported No treatment information was provided   This case was linked to MOD-2021-239072 (Patient Link).
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Rash macular
Clinical narrative: Splotches; Rash; Lots of itching; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (Splotches), RASH (Rash) and PRURITUS (Lots of itching) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH MACULAR (Splotches), RASH (Rash) and PRURITUS (Lots of itching). At the time of the report, RASH MACULAR (Splotches), RASH (Rash) and PRURITUS (Lots of itching) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The action taken with mRNA-1273(Moderna COVID-19 vaccine) was not applicable. No concomitant medication was mentioned. Treatment medication mentioned is Cortisone cream.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Chills, Erythema, Insomnia
Clinical narrative: My energy level remains fairly low, and I lie down frequently during day; Didn't sleep all night; erythema; Extreme aching of all muscles and joints in body; Extreme aching of all muscles and joints in body; chills; felt back itchy at night, saw rash in mirror the next morning; felt back itchy at night, saw rash in mirror the next morning; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (My energy level remains fairly low, and I lie down frequently during day), INSOMNIA (Didn't sleep all night), PRURITUS (felt back itchy at night, saw rash in mirror the next morning), ERYTHEMA (erythema) and RASH (felt back itchy at night, saw rash in mirror the next morning) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20A and 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypersensitivity reaction, Urticaria, Hay fever, Drug allergy (swelling of fingers,lips) since 1960, Drug allergy (rash, stomach upset) since 2019, Drug allergy (Rash) since 2019, Arrhythmia since 2011 and Urinary retention (self catherize twice daily). Concomitant products included APIXABAN (ELIQUIS) and METOPROLOL for Arrhythmia.   On 27-Jan-2021 at 12:10 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021 at 10:10 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Feb-2021, the patient experienced PRURITUS (felt back itchy at night, saw rash in mirror the next morning) and RASH (felt back itchy at night, saw rash in mirror the next morning). On an unknown date, the patient experienced ASTHENIA (My energy level remains fairly low, and I lie down frequently during day), INSOMNIA (Didn't sleep all night), ERYTHEMA (erythema), MYALGIA (Extreme aching of all muscles and joints in body), ARTHRALGIA (Extreme aching of all muscles and joints in body) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL) for Ache, at an unspecified dose and frequency. On 06-Feb-2021, PRURITUS (felt back itchy at night, saw rash in mirror the next morning) and RASH (felt back itchy at night, saw rash in mirror the next morning) had resolved. At the time of the report, ASTHENIA (My energy level remains fairly low, and I lie down frequently during day), INSOMNIA (Didn't sleep all night), ERYTHEMA (erythema), MYALGIA (Extreme aching of all muscles and joints in body), ARTHRALGIA (Extreme aching of all muscles and joints in body) and CHILLS (chills) outcome was unknown.            Concomitant product also included Centrum Silver for good health.   This case was linked to MOD-2021-029271 (Patient Link).
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pruritus, Rash
Clinical narrative: My energy level remains fairly low, and I lie down frequently during day; Didn't sleep all night; erythema; Extreme aching of all muscles and joints in body; Extreme aching of all muscles and joints in body; chills; felt back itchy at night, saw rash in mirror the next morning; felt back itchy at night, saw rash in mirror the next morning; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (My energy level remains fairly low, and I lie down frequently during day), INSOMNIA (Didn't sleep all night), PRURITUS (felt back itchy at night, saw rash in mirror the next morning), ERYTHEMA (erythema) and RASH (felt back itchy at night, saw rash in mirror the next morning) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20A and 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypersensitivity reaction, Urticaria, Hay fever, Drug allergy (swelling of fingers,lips) since 1960, Drug allergy (rash, stomach upset) since 2019, Drug allergy (Rash) since 2019, Arrhythmia since 2011 and Urinary retention (self catherize twice daily). Concomitant products included APIXABAN (ELIQUIS) and METOPROLOL for Arrhythmia.   On 27-Jan-2021 at 12:10 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021 at 10:10 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Feb-2021, the patient experienced PRURITUS (felt back itchy at night, saw rash in mirror the next morning) and RASH (felt back itchy at night, saw rash in mirror the next morning). On an unknown date, the patient experienced ASTHENIA (My energy level remains fairly low, and I lie down frequently during day), INSOMNIA (Didn't sleep all night), ERYTHEMA (erythema), MYALGIA (Extreme aching of all muscles and joints in body), ARTHRALGIA (Extreme aching of all muscles and joints in body) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL) for Ache, at an unspecified dose and frequency. On 06-Feb-2021, PRURITUS (felt back itchy at night, saw rash in mirror the next morning) and RASH (felt back itchy at night, saw rash in mirror the next morning) had resolved. At the time of the report, ASTHENIA (My energy level remains fairly low, and I lie down frequently during day), INSOMNIA (Didn't sleep all night), ERYTHEMA (erythema), MYALGIA (Extreme aching of all muscles and joints in body), ARTHRALGIA (Extreme aching of all muscles and joints in body) and CHILLS (chills) outcome was unknown.            Concomitant product also included Centrum Silver for good health.   This case was linked to MOD-2021-029271 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Headache, Myalgia, Pyrexia
Clinical narrative: Headache; Fever; Arm swell; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), PYREXIA (Fever) and MYALGIA (Arm swell) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headache), PYREXIA (Fever) and MYALGIA (Arm swell). At the time of the report, HEADACHE (Headache), PYREXIA (Fever) and MYALGIA (Arm swell) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided. Treatment information was not provided.