chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Headache, Hyperhidrosis, Pain
Clinical narrative: chills; sweating; felt like she was not having a lot of energy; body aches; fever; feel really hot; mild headache; soreness at the injection site; This spontaneous case was reported by a physician and describes the occurrence of CHILLS (chills), HYPERHIDROSIS (sweating), ASTHENIA (felt like she was not having a lot of energy), PAIN (body aches) and PYREXIA (fever) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced CHILLS (chills), HYPERHIDROSIS (sweating), ASTHENIA (felt like she was not having a lot of energy), PAIN (body aches), PYREXIA (fever), VACCINATION SITE WARMTH (feel really hot), HEADACHE (mild headache) and VACCINATION SITE PAIN (soreness at the injection site). The patient was treated with IBUPROFEN ongoing since an unknown date for Headache, at a dose of 800 mg. At the time of the report, CHILLS (chills), HYPERHIDROSIS (sweating), ASTHENIA (felt like she was not having a lot of energy), PAIN (body aches), PYREXIA (fever), VACCINATION SITE WARMTH (feel really hot), HEADACHE (mild headache) and VACCINATION SITE PAIN (soreness at the injection site) 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
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain, Vaccination site warmth
Clinical narrative: chills; sweating; felt like she was not having a lot of energy; body aches; fever; feel really hot; mild headache; soreness at the injection site; This spontaneous case was reported by a physician and describes the occurrence of CHILLS (chills), HYPERHIDROSIS (sweating), ASTHENIA (felt like she was not having a lot of energy), PAIN (body aches) and PYREXIA (fever) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced CHILLS (chills), HYPERHIDROSIS (sweating), ASTHENIA (felt like she was not having a lot of energy), PAIN (body aches), PYREXIA (fever), VACCINATION SITE WARMTH (feel really hot), HEADACHE (mild headache) and VACCINATION SITE PAIN (soreness at the injection site). The patient was treated with IBUPROFEN ongoing since an unknown date for Headache, at a dose of 800 mg. At the time of the report, CHILLS (chills), HYPERHIDROSIS (sweating), ASTHENIA (felt like she was not having a lot of energy), PAIN (body aches), PYREXIA (fever), VACCINATION SITE WARMTH (feel really hot), HEADACHE (mild headache) and VACCINATION SITE PAIN (soreness at the injection site) 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
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Injection site itchy; Injection site red; Injection site started being swollen again; Injection site a little swollen; Injection site sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Injection site itchy), VACCINATION SITE SWELLING (Injection site a little swollen), VACCINATION SITE PAIN (Injection site sore), VACCINATION SITE ERYTHEMA (Injection site red) and VACCINATION SITE SWELLING (Injection site started being swollen again) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE for an unknown indication.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced VACCINATION SITE SWELLING (Injection site a little swollen) and VACCINATION SITE PAIN (Injection site sore). On 14-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (Injection site itchy), VACCINATION SITE ERYTHEMA (Injection site red) and VACCINATION SITE SWELLING (Injection site started being swollen again). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. On 06-Mar-2021, VACCINATION SITE SWELLING (Injection site a little swollen) and VACCINATION SITE PAIN (Injection site sore) had resolved. At the time of the report, VACCINATION SITE PRURITUS (Injection site itchy), VACCINATION SITE ERYTHEMA (Injection site red) and VACCINATION SITE SWELLING (Injection site started being swollen again) outcome was unknown.            Concomitant medication provided also include hormone replacement patch.  Treatment provided include anti itch-cream.   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Follow up received on 10-May-2021, the details about, De challenge and re challenge results updated
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Vaccination site pain
Clinical narrative: experiencing body aches; soreness near injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (soreness near injection site) and MYALGIA (experiencing body aches) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     No medical history were reported.  Concomitant products included AMLODIPINE, LISINOPRIL, LEVOTHYROXINE and PRAVASTATIN for an unknown indication.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced VACCINATION SITE PAIN (soreness near injection site). On 17-Mar-2021, the patient experienced MYALGIA (experiencing body aches). The patient was treated with PARACETAMOL (TYLENOL) for Vaccination site pain and Myalgia, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (soreness near injection site) and MYALGIA (experiencing body aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Exposure via breast milk
Clinical narrative: Received vaccine during breastfeeding; This spontaneous case was reported by a consumer and describes the occurrence of EXPOSURE VIA BREAST MILK (Received vaccine during breastfeeding) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    MEDICAL HISTORY (Parent): Concurrent medical conditions included Maternal exposure during breast feeding.    No Medical History information was reported.   In March 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 an unknown date, the patient experienced EXPOSURE VIA BREAST MILK (Received vaccine during breastfeeding). At the time of the report, EXPOSURE VIA BREAST MILK (Received vaccine during breastfeeding) had resolved. Not Provided          No Concomitant medicines were provided.  No Treatment medicines were provided.   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: Updated Month of Vaccination
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Fatigue, Headache, Nausea, SARS-CoV-2 test
Clinical narrative: COUGHING; MILD HEADACHE TO TERRIBLE HEADACHES; NAUSEA; FATIGUE; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (COUGHING), HEADACHE (MILD HEADACHE TO TERRIBLE HEADACHES), NAUSEA (NAUSEA) and FATIGUE (FATIGUE) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COUGH (COUGHING), HEADACHE (MILD HEADACHE TO TERRIBLE HEADACHES), NAUSEA (NAUSEA) and FATIGUE (FATIGUE). At the time of the report, COUGH (COUGHING), HEADACHE (MILD HEADACHE TO TERRIBLE HEADACHES), NAUSEA (NAUSEA) and FATIGUE (FATIGUE) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Mar-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant and treatment medication were not provided.
Sex: F
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: heart racing while taking the first dose; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (heart racing while taking the first 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 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced PALPITATIONS (heart racing while taking the first dose). On 06-Feb-2021, PALPITATIONS (heart racing while taking the first dose) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  Treatment information was not provided.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia
Clinical narrative: Muscle pain; Joint soreness; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Muscle pain) and ARTHRALGIA (Joint soreness) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A and 015M20A) for COVID-19 vaccination.     The patient's past medical history included Lyme disease.   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Mar-2021, the patient experienced MYALGIA (Muscle pain) and ARTHRALGIA (Joint soreness). At the time of the report, MYALGIA (Muscle pain) and ARTHRALGIA (Joint soreness) outcome was unknown. Not Provided          Concomitant Product use was not provided.  Treatment information was not provided.  Action taken with mRNA-1273 in response to events was not applicable.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: Maternal exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     Family history included Congenital heart disease NOS (paternal cousin). Concomitant products included PAROXETINE HYDROCHLORIDE (PAXIL [PAROXETINE HYDROCHLORIDE]) and MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 06-Jun-2021. On 08-Mar-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). On 08-Mar-2021, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Myalgia, Pain in extremity, Pyrexia
Clinical narrative: body aches; fever; glands were swollen; soreness in arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (body aches), PYREXIA (fever), LYMPHADENOPATHY (glands were swollen) and PAIN IN EXTREMITY (soreness in arm) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    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 MYALGIA (body aches), PYREXIA (fever), LYMPHADENOPATHY (glands were swollen) and PAIN IN EXTREMITY (soreness in arm). On 06-Mar-2021, PYREXIA (fever) had resolved. On 11-Mar-2021, MYALGIA (body aches), LYMPHADENOPATHY (glands were swollen) and PAIN IN EXTREMITY (soreness in arm) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient was treated with Tylenol and Ibuprofen
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Vaccination site discomfort
Clinical narrative: after shot she felt that shot is went down in her finger; tingling sensation in left hand fingers; feeling like pricking needle in her hand sometime in feet; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOMFORT (after shot she felt that shot is went down in her finger), PARAESTHESIA (tingling sensation in left hand fingers) and PARAESTHESIA (feeling like pricking needle in her hand sometime in feet) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced VACCINATION SITE DISCOMFORT (after shot she felt that shot is went down in her finger), PARAESTHESIA (tingling sensation in left hand fingers) and PARAESTHESIA (feeling like pricking needle in her hand sometime in feet). At the time of the report, VACCINATION SITE DISCOMFORT (after shot she felt that shot is went down in her finger) and PARAESTHESIA (tingling sensation in left hand fingers) had resolved and PARAESTHESIA (feeling like pricking needle in her hand sometime in feet) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Swollen arm at injection site; Red Arm at injection site; Sore Arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore Arm), PERIPHERAL SWELLING (Swollen arm at injection site) and INJECTION SITE ERYTHEMA (Red Arm at injection site) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore Arm). On 16-Mar-2021, the patient experienced PERIPHERAL SWELLING (Swollen arm at injection site) and INJECTION SITE ERYTHEMA (Red Arm at injection site). At the time of the report, PAIN IN EXTREMITY (Sore Arm), PERIPHERAL SWELLING (Swollen arm at injection site) and INJECTION SITE ERYTHEMA (Red Arm at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were reported No treatment medications were reported
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site mass, Vaccination site pain, Vaccination site pruritus
Clinical narrative: itchiness at the area of the injection; soreness at the area of the injection; red bumps (mosquito bite like) at the area of the injection; red bumps (mosquito bite like) at the area of the injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (itchiness at the area of the injection), VACCINATION SITE PAIN (soreness at the area of the injection), VACCINATION SITE ERYTHEMA (red bumps (mosquito bite like) at the area of the injection) and VACCINATION SITE MASS (red bumps (mosquito bite like) at the area of the injection) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (itchiness at the area of the injection), VACCINATION SITE PAIN (soreness at the area of the injection), VACCINATION SITE ERYTHEMA (red bumps (mosquito bite like) at the area of the injection) and VACCINATION SITE MASS (red bumps (mosquito bite like) at the area of the injection). At the time of the report, VACCINATION SITE PRURITUS (itchiness at the area of the injection), VACCINATION SITE PAIN (soreness at the area of the injection), VACCINATION SITE ERYTHEMA (red bumps (mosquito bite like) at the area of the injection) and VACCINATION SITE MASS (red bumps (mosquito bite like) at the area of the injection) 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.   Patient was allergic to many unspecified medications where she will break out in hives.  No concomitant medications was reported by the reporter No treatment medications was  provided by the reporter.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Feeling cold, Malaise, Pain in extremity, Pyrexia
Clinical narrative: not feeling well; chills; 102 Fahrenheit fever; sore arm; very very very cold; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), FEELING COLD (very very very cold), MALAISE (not feeling well), CHILLS (chills) and PYREXIA (102 Fahrenheit fever) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm), FEELING COLD (very very very cold), CHILLS (chills) and PYREXIA (102 Fahrenheit fever). On 17-Mar-2021, the patient experienced MALAISE (not feeling well). At the time of the report, PAIN IN EXTREMITY (sore arm), FEELING COLD (very very very cold), MALAISE (not feeling well), CHILLS (chills) and PYREXIA (102 Fahrenheit fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Mar-2021, Pyrexia: 102 (High) 102.         Concomitant product use was not provided by the reporter.   Treatment information was not provided
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect route of product administration
Clinical narrative: Gotten injected in her triceps vs her deltoid muscle; A spontaneous report was received from a consumer concerning a 45-years-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) in her triceps vs her deltoid muscle/incorrect route of product administration.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 08 Mar 2021, the patient received their first of two planned doses of mRNA-1273 (Batch Number: Unknown) for prophylaxis of COVID-19 infection.  On 08 Mar 2021, the patient got injected in her triceps vs her deltoid muscle. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcomes of the event got injected in her triceps vs her deltoid muscle was resolved on 08 Mar 2021.; Reporter's Comments: This report refers to a case of error for mRNA-1273 with no associated AEs.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Herpes zoster, Pain in extremity
Clinical narrative: Shingles; ongoing joint pain in both feet; ongoing joint pain in both hands; This spontaneous case was reported by a non-health professional and describes the occurrence of ARTHRALGIA (ongoing joint pain in both hands), HERPES ZOSTER (Shingles) and PAIN IN EXTREMITY (ongoing joint pain in both feet) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, the patient experienced ARTHRALGIA (ongoing joint pain in both hands) and PAIN IN EXTREMITY (ongoing joint pain in both feet). On 07-Apr-2021, the patient experienced HERPES ZOSTER (Shingles). At the time of the report, ARTHRALGIA (ongoing joint pain in both hands), HERPES ZOSTER (Shingles) and PAIN IN EXTREMITY (ongoing joint pain in both feet) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 07-Apr-2021: new adverse event reported
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Decreased appetite, Diarrhoea, Ear pain
Clinical narrative: so weak; was up all night itching all over my face, arms, legs; stayed up till 4:30am; pain in my ears; pain and ache all over; terrible headache; nausea; temperature was 101 degree; Couldn't eat and did not want to drink; diarrhea; started getting sick few hours after the shot; wasn't feeling good; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (started getting sick few hours after the shot), MALAISE (wasn't feeling good), ASTHENIA (so weak), DECREASED APPETITE (Couldn't eat and did not want to drink) and DIARRHOEA (diarrhea) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 15-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 ILLNESS (started getting sick few hours after the shot) and MALAISE (wasn't feeling good). On 16-Mar-2021, the patient experienced DECREASED APPETITE (Couldn't eat and did not want to drink), DIARRHOEA (diarrhea), HEADACHE (terrible headache), NAUSEA (nausea) and PYREXIA (temperature was 101 degree). On 17-Mar-2021, the patient experienced PRURITUS (was up all night itching all over my face, arms, legs), INSOMNIA (stayed up till 4:30am), EAR PAIN (pain in my ears) and MYALGIA (pain and ache all over). On an unknown date, the patient experienced ASTHENIA (so weak). The patient was treated with PARACETAMOL (TYLENOL) for Feeling unwell, at an unspecified dose and frequency. At the time of the report, ILLNESS (started getting sick few hours after the shot), MALAISE (wasn't feeling good), ASTHENIA (so weak), DECREASED APPETITE (Couldn't eat and did not want to drink), DIARRHOEA (diarrhea), PRURITUS (was up all night itching all over my face, arms, legs), INSOMNIA (stayed up till 4:30am), EAR PAIN (pain in my ears), MYALGIA (pain and ache all over), HEADACHE (terrible headache), NAUSEA (nausea) and PYREXIA (temperature was 101 degree) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Mar-2021, Body temperature: 101 (High) 101 degree F.         No concomitant medications were reported.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Illness, Insomnia, Malaise, Myalgia
Clinical narrative: so weak; was up all night itching all over my face, arms, legs; stayed up till 4:30am; pain in my ears; pain and ache all over; terrible headache; nausea; temperature was 101 degree; Couldn't eat and did not want to drink; diarrhea; started getting sick few hours after the shot; wasn't feeling good; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (started getting sick few hours after the shot), MALAISE (wasn't feeling good), ASTHENIA (so weak), DECREASED APPETITE (Couldn't eat and did not want to drink) and DIARRHOEA (diarrhea) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 15-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 ILLNESS (started getting sick few hours after the shot) and MALAISE (wasn't feeling good). On 16-Mar-2021, the patient experienced DECREASED APPETITE (Couldn't eat and did not want to drink), DIARRHOEA (diarrhea), HEADACHE (terrible headache), NAUSEA (nausea) and PYREXIA (temperature was 101 degree). On 17-Mar-2021, the patient experienced PRURITUS (was up all night itching all over my face, arms, legs), INSOMNIA (stayed up till 4:30am), EAR PAIN (pain in my ears) and MYALGIA (pain and ache all over). On an unknown date, the patient experienced ASTHENIA (so weak). The patient was treated with PARACETAMOL (TYLENOL) for Feeling unwell, at an unspecified dose and frequency. At the time of the report, ILLNESS (started getting sick few hours after the shot), MALAISE (wasn't feeling good), ASTHENIA (so weak), DECREASED APPETITE (Couldn't eat and did not want to drink), DIARRHOEA (diarrhea), PRURITUS (was up all night itching all over my face, arms, legs), INSOMNIA (stayed up till 4:30am), EAR PAIN (pain in my ears), MYALGIA (pain and ache all over), HEADACHE (terrible headache), NAUSEA (nausea) and PYREXIA (temperature was 101 degree) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Mar-2021, Body temperature: 101 (High) 101 degree F.         No concomitant medications were reported.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pruritus, Pyrexia
Clinical narrative: so weak; was up all night itching all over my face, arms, legs; stayed up till 4:30am; pain in my ears; pain and ache all over; terrible headache; nausea; temperature was 101 degree; Couldn't eat and did not want to drink; diarrhea; started getting sick few hours after the shot; wasn't feeling good; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (started getting sick few hours after the shot), MALAISE (wasn't feeling good), ASTHENIA (so weak), DECREASED APPETITE (Couldn't eat and did not want to drink) and DIARRHOEA (diarrhea) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 15-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 ILLNESS (started getting sick few hours after the shot) and MALAISE (wasn't feeling good). On 16-Mar-2021, the patient experienced DECREASED APPETITE (Couldn't eat and did not want to drink), DIARRHOEA (diarrhea), HEADACHE (terrible headache), NAUSEA (nausea) and PYREXIA (temperature was 101 degree). On 17-Mar-2021, the patient experienced PRURITUS (was up all night itching all over my face, arms, legs), INSOMNIA (stayed up till 4:30am), EAR PAIN (pain in my ears) and MYALGIA (pain and ache all over). On an unknown date, the patient experienced ASTHENIA (so weak). The patient was treated with PARACETAMOL (TYLENOL) for Feeling unwell, at an unspecified dose and frequency. At the time of the report, ILLNESS (started getting sick few hours after the shot), MALAISE (wasn't feeling good), ASTHENIA (so weak), DECREASED APPETITE (Couldn't eat and did not want to drink), DIARRHOEA (diarrhea), PRURITUS (was up all night itching all over my face, arms, legs), INSOMNIA (stayed up till 4:30am), EAR PAIN (pain in my ears), MYALGIA (pain and ache all over), HEADACHE (terrible headache), NAUSEA (nausea) and PYREXIA (temperature was 101 degree) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Mar-2021, Body temperature: 101 (High) 101 degree F.         No concomitant medications were reported.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, Malaise, Pyrexia, SARS-CoV-2 test
Clinical narrative: feels like he has COVID; feel ill; fever that rose from 99 degrees to 101.2 degrees; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (feels like he has COVID), MALAISE (feel ill) and PYREXIA (fever that rose from 99 degrees to 101.2 degrees) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced COVID-19 (feels like he has COVID), MALAISE (feel ill) and PYREXIA (fever that rose from 99 degrees to 101.2 degrees). At the time of the report, COVID-19 (feels like he has COVID), MALAISE (feel ill) and PYREXIA (fever that rose from 99 degrees to 101.2 degrees) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Dec-2020, SARS-CoV-2 test: positive Positive. On 17-Mar-2021, Body temperature: 99 to 101.2 (High) rose from 99 degrees to 101.2 degrees.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were reported.  No Treatment information was reported.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: m patient was 11 weeks pregnant when they received the first dose of the Moderna vaccine; This spontaneous prospective pregnancy case was reported by a physician and describes the occurrence of EXPOSURE DURING PREGNANCY (m patient was 11 weeks pregnant when they received the first dose of the Moderna vaccine) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN LOW) for Hypertension, MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]), VITAMIN B6, LORATADINE (CLARITIN [LORATADINE]), DOXYLAMINE;PYRIDOXINE and SERTRALINE HYDROCHLORIDE (ZOLOFT) for an unknown indication.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 20-Sep-2021. On 06-Mar-2021, the patient experienced EXPOSURE DURING PREGNANCY (m patient was 11 weeks pregnant when they received the first dose of the Moderna vaccine). At the time of the report, EXPOSURE DURING PREGNANCY (m patient was 11 weeks pregnant when they received the first dose of the Moderna 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 treatment medication information was reported.
Age: 53.0
Sex: U
Vaccine: COVID19
Symptoms: Product temperature excursion issue
Clinical narrative: received vaccine after temperature excursion; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (received vaccine after temperature excursion) in a 53-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     No Medical History information was reported.    On 18-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (received vaccine after temperature excursion). On 18-Mar-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (received vaccine after temperature excursion) had resolved.        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.   Concomitant product use was not provided by the reporter.   Treatment information was not provided.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Myalgia
Clinical narrative: weakness; fatigued; body pain; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ASTHENIA (weakness), FATIGUE (fatigued) and MYALGIA (body pain) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included CICLOSPORIN (RESTASIS) for Eye dryness, PANTOPRAZOLE for GERD, MAGNESIUM OXIDE, ORYZANOL, PYRIDOXINE HYDROCHLORIDE, THIAMINE MONONITRATE, TOCOPHERYL ACETATE (MAGWELL) for Magnesium supplementation, ZOLPIDEM for Sleep disorder NOS, AMYLASE, ASCORBIC ACID, CELLULASE, FOLIC ACID, LIPASE, PROTEASE NOS (JUICE PLUS) for Supplementation therapy.    On 02-Mar-2021 at 10:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021 at 3:00 PM, the patient experienced FATIGUE (fatigued) and MYALGIA (body pain). On 03-Mar-2021, the patient experienced ASTHENIA (weakness). The patient was treated with PARACETAMOL (TYLENOL) in March 2021 for Fatigue, at an unspecified dose and frequency. At the time of the report, ASTHENIA (weakness), FATIGUE (fatigued) and MYALGIA (body pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Diarrhoea, Dizziness, Fatigue, Myalgia
Clinical narrative: fatigue, weakness & dizziness; felt generally bad with weakness; tiredness; muscle ache; Pain; diarrhea; This spontaneous case was reported by a patient and describes the occurrence of ASTHENIA (felt generally bad with weakness), FATIGUE (tiredness), MYALGIA (muscle ache), PAIN (Pain) and DIARRHOEA (diarrhea) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension and COPD.   On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Mar-2021, the patient experienced ASTHENIA (felt generally bad with weakness), FATIGUE (tiredness), MYALGIA (muscle ache), PAIN (Pain) and DIARRHOEA (diarrhea). On 11-Mar-2021, the patient experienced DIZZINESS (fatigue, weakness & dizziness). On 11-Mar-2021, FATIGUE (tiredness), MYALGIA (muscle ache), PAIN (Pain) and DIARRHOEA (diarrhea) had resolved. At the time of the report, ASTHENIA (felt generally bad with weakness) and DIZZINESS (fatigue, weakness & dizziness) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant medication included unspecified hypertensive and COPD medication.  No treatment medication included.   This case was linked to MOD-2021-112169 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: Updated outcomes for 1st dose
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: fatigue, weakness & dizziness; felt generally bad with weakness; tiredness; muscle ache; Pain; diarrhea; This spontaneous case was reported by a patient and describes the occurrence of ASTHENIA (felt generally bad with weakness), FATIGUE (tiredness), MYALGIA (muscle ache), PAIN (Pain) and DIARRHOEA (diarrhea) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension and COPD.   On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Mar-2021, the patient experienced ASTHENIA (felt generally bad with weakness), FATIGUE (tiredness), MYALGIA (muscle ache), PAIN (Pain) and DIARRHOEA (diarrhea). On 11-Mar-2021, the patient experienced DIZZINESS (fatigue, weakness & dizziness). On 11-Mar-2021, FATIGUE (tiredness), MYALGIA (muscle ache), PAIN (Pain) and DIARRHOEA (diarrhea) had resolved. At the time of the report, ASTHENIA (felt generally bad with weakness) and DIZZINESS (fatigue, weakness & dizziness) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant medication included unspecified hypertensive and COPD medication.  No treatment medication included.   This case was linked to MOD-2021-112169 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: Updated outcomes for 1st dose
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dyspnoea, Headache, Myalgia, Nasopharyngitis
Clinical narrative: cold; Cannot take deep breath; Headache; Mild Fever; Chill; aches and pains, body aches; Left Arm sore and Hurting; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (cold), DYSPNOEA (Cannot take deep breath), PAIN IN EXTREMITY (Left Arm sore and Hurting), HEADACHE (Headache) and CHILLS (Chill) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced PAIN IN EXTREMITY (Left Arm sore and Hurting), CHILLS (Chill) and MYALGIA (aches and pains, body aches). On 17-Mar-2021, the patient experienced NASOPHARYNGITIS (cold), DYSPNOEA (Cannot take deep breath), HEADACHE (Headache) and PYREXIA (Mild Fever). The patient was treated with PARACETAMOL (TYLENOL) on 12-Mar-2021 for Pain in arm, at an unspecified dose and frequency. At the time of the report, NASOPHARYNGITIS (cold), DYSPNOEA (Cannot take deep breath), PAIN IN EXTREMITY (Left Arm sore and Hurting), HEADACHE (Headache), CHILLS (Chill), MYALGIA (aches and pains, body aches) and PYREXIA (Mild Fever) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.  The patient reported on 12-Mar-2021, she experienced chill, aches and pains, headache, arm sore and hurting. Patient took Tylenol and felt better. On 17-Mar-2021, she experienced chills, body ache, headache, mild fever, cannot take deep breath and cold coming feeling. Patient took Tylenol.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: cold; Cannot take deep breath; Headache; Mild Fever; Chill; aches and pains, body aches; Left Arm sore and Hurting; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (cold), DYSPNOEA (Cannot take deep breath), PAIN IN EXTREMITY (Left Arm sore and Hurting), HEADACHE (Headache) and CHILLS (Chill) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced PAIN IN EXTREMITY (Left Arm sore and Hurting), CHILLS (Chill) and MYALGIA (aches and pains, body aches). On 17-Mar-2021, the patient experienced NASOPHARYNGITIS (cold), DYSPNOEA (Cannot take deep breath), HEADACHE (Headache) and PYREXIA (Mild Fever). The patient was treated with PARACETAMOL (TYLENOL) on 12-Mar-2021 for Pain in arm, at an unspecified dose and frequency. At the time of the report, NASOPHARYNGITIS (cold), DYSPNOEA (Cannot take deep breath), PAIN IN EXTREMITY (Left Arm sore and Hurting), HEADACHE (Headache), CHILLS (Chill), MYALGIA (aches and pains, body aches) and PYREXIA (Mild Fever) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.  The patient reported on 12-Mar-2021, she experienced chill, aches and pains, headache, arm sore and hurting. Patient took Tylenol and felt better. On 17-Mar-2021, she experienced chills, body ache, headache, mild fever, cannot take deep breath and cold coming feeling. Patient took Tylenol.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia
Clinical narrative: muscle aches; headaches; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (muscle aches) and HEADACHE (headaches) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0315M20A and 044A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MYALGIA (muscle aches) and HEADACHE (headaches). At the time of the report, MYALGIA (muscle aches) and HEADACHE (headaches) outcome was unknown. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medication information was provided.  No treatment products information was provided.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Ear swelling
Clinical narrative: left ear swelled up- same side as the injection site; This spontaneous case was reported by a consumer and describes the occurrence of EAR SWELLING (left ear swelled up- same side as the injection site) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     The patient's past medical history included Guillain Barre syndrome.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced EAR SWELLING (left ear swelled up- same side as the injection site). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) for Ear swelling, at an unspecified dose and frequency. At the time of the report, EAR SWELLING (left ear swelled up- same side as the injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Tachycardia
Clinical narrative: fast heartbeat; This spontaneous case was reported by a patient and describes the occurrence of TACHYCARDIA (fast heartbeat) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced TACHYCARDIA (fast heartbeat). On 17-Mar-2021, TACHYCARDIA (fast heartbeat) had resolved.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant product use was not provided by the reporter.   Treatment information was not provided.