chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Broke out in hives, has tremendous amount of hives; Congested; Entire body is itchy; Hasn't slept much, she's struggling; Some chills; Some fever; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Broke out in hives, has tremendous amount of hives), NASAL CONGESTION (Congested), PRURITUS (Entire body is itchy), INSOMNIA (Hasn't slept much, she's struggling) and CHILLS (Some chills) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Immunocompromised and Lyme disease (The patient used to be in a tremendous amount of antibiotics in the past). Concomitant products included VITAMINS NOS for an unknown indication.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In September 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In September 2021, the patient experienced CHILLS (Some chills) and PYREXIA (Some fever). On 21-Sep-2021, the patient experienced URTICARIA (Broke out in hives, has tremendous amount of hives), NASAL CONGESTION (Congested), PRURITUS (Entire body is itchy) and INSOMNIA (Hasn't slept much, she's struggling). The patient was treated with PREDNISONE at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, URTICARIA (Broke out in hives, has tremendous amount of hives), NASAL CONGESTION (Congested), PRURITUS (Entire body is itchy), INSOMNIA (Hasn't slept much, she's struggling), CHILLS (Some chills) and PYREXIA (Some fever) outcome was unknown.            Treatment medicines include Prednisone and Benadryl
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: diarrhea for a week due to which she could not leave the house; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea for a week due to which she could not leave the house) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A, 025L20A and 058E21A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced DIARRHOEA (diarrhea for a week due to which she could not leave the house). The patient was treated with LOPERAMIDE HYDROCHLORIDE (IMODIUM) for Diarrhea, at an unspecified dose and frequency. In February 2021, DIARRHOEA (diarrhea for a week due to which she could not leave the house) had resolved.            No relevant concomitant medications were reported.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: caught COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (caught COVID-19) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (caught COVID-19). At the time of the report, COVID-19 (caught COVID-19) outcome was unknown.            No relevant concomitant medications were reported. Treatment information was unknown.; Sender's Comments: This case concerns a 40-year-old male patient with no relevant medical history reported, who experienced non-serious unexpected event of COVID-19. The event occurred on an unknown date after the first dose of Spikevax. Rechallenge was unknown since information regarding second dose was not provided. The benefit-risk relationship of drug is not affected by this report
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Off label use, Pulmonary oedema
Clinical narrative: Shortness of breath/suddenly she could not breathe at all; took like 7 liters of fluid out of her lungs/her lungs were filled up with fluid; Patient received 3rd dose and was not immunocompromised; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY OEDEMA and DYSPNOEA in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 20-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In September 2021, the patient experienced PULMONARY OEDEMA (seriousness criteria hospitalization and medically significant). On 20-Sep-2021, the patient experienced DYSPNOEA (seriousness criterion hospitalization) and OFF LABEL USE (Patient received 3rd dose and was not immunocompromised). The patient was hospitalized on sometime in September 2021 due to DYSPNOEA and PULMONARY OEDEMA. On 20-Sep-2021, OFF LABEL USE (Patient received 3rd dose and was not immunocompromised) had resolved. At the time of the report, PULMONARY OEDEMA and DYSPNOEA outcome was unknown.            Reporter mentioned that the only concomitant medication was the diuretic. Treatment medication given as Diuretic and Oxygen.  Reporter mentioned that the patient was put on a ventilator. Her mother is usually active and independent. She said her mother was not immunosuppressed. She was having shortness of breath and saw her cardiologist in August and had a chest X-ray and had another appointment for the cardiologist in September. Patient was not able to breath. The paramedic got here, put all those monitors on her, she could not breathe. Then she was in the ICU on a vent, that was on Monday night. Then she got off the vent and now she's on oxygen. She drives, she had gone to a funeral out of town that day. Her daughter said that if our Safety department can't talk to her because of HIPPA that she has a medical power attorney and also her mom is talking now (she could not talk before because she was on a vent).  This case concerns an 81 year-old female with no medical history provided, who experienced the unexpected event of Pulmonary Oedema and Dyspnoea. The event of Pulmonary Oedema occurred sometime in September, while Dyspnoea occurred on the same day as the third dose of Moderna COVID-19 Vaccine. The benefit-risk relationship of Moderna COVID-19 Vaccine in not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Arthropathy
Clinical narrative: Everyone had knee problem after receiving moderna vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ARTHROPATHY (Everyone had knee problem after receiving moderna vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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 ARTHROPATHY (Everyone had knee problem after receiving moderna vaccine). At the time of the report, ARTHROPATHY (Everyone had knee problem after receiving moderna vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant was reported. No treatment was reported.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Interchange of vaccine products, Mass
Clinical narrative: Knot which is hot in her upper arm; Knot which is hot in her upper arm; Received her 1st and 2nd doses from Pfizer and received a 3rd Moderna shot; This spontaneous case was reported by a consumer and describes the occurrence of MASS (Knot which is hot in her upper arm), FEELING HOT (Knot which is hot in her upper arm) and INTERCHANGE OF VACCINE PRODUCTS (Received her 1st and 2nd doses from Pfizer and received a 3rd Moderna shot) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006ZDIA) for COVID-19 vaccination.     Previously administered products included for an unreported indication: PFIZER BIONTECH COVID-19 VACCINE (Lot number: EN6200, First dose) on 27-Feb-2021, PFIZER BIONTECH COVID-19 VACCINE (Lot number: EN6206 and Second dose) on 20-Mar-2021.    On 23-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Sep-2021, the patient experienced MASS (Knot which is hot in her upper arm), FEELING HOT (Knot which is hot in her upper arm) and INTERCHANGE OF VACCINE PRODUCTS (Received her 1st and 2nd doses from Pfizer and received a 3rd Moderna shot). On 23-Sep-2021, INTERCHANGE OF VACCINE PRODUCTS (Received her 1st and 2nd doses from Pfizer and received a 3rd Moderna shot) had resolved. At the time of the report, MASS (Knot which is hot in her upper arm) and FEELING HOT (Knot which is hot in her upper arm) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: soreness of arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness of arm) in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (soreness of arm). At the time of the report, PAIN IN EXTREMITY (soreness of arm) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant medications were not provided by reporter.  Treatment information was not provided by reporter.   This case was linked to MOD-2021-331145, MOD-2021-331146 (E2B Linked Report).; Sender's Comments:  MOD-2021-331146:Dose 3 case MOD-2021-331145:Dose 2 case
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Hypoaesthesia, Malaise, Paraesthesia
Clinical narrative: Sick after 2nd vaccine; Swollen Right Foot after 2nd vaccine; Tingling in arms, feet and legs after 2nd vaccine; Numbness in the arms, feet and legs after the 2nd vaccine; Fever 102F after 2nd vaccine; Chills after 2nd vaccine; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Sick after 2nd vaccine), PERIPHERAL SWELLING (Swollen Right Foot after 2nd vaccine), PARAESTHESIA (Tingling in arms, feet and legs after 2nd vaccine), HYPOAESTHESIA (Numbness in the arms, feet and legs after the 2nd vaccine) and PYREXIA (Fever 102F after 2nd vaccine) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   In August 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Sep-2021, the patient experienced MALAISE (Sick after 2nd vaccine), PERIPHERAL SWELLING (Swollen Right Foot after 2nd vaccine), PARAESTHESIA (Tingling in arms, feet and legs after 2nd vaccine), HYPOAESTHESIA (Numbness in the arms, feet and legs after the 2nd vaccine), PYREXIA (Fever 102F after 2nd vaccine) and CHILLS (Chills after 2nd vaccine). On 12-Sep-2021, MALAISE (Sick after 2nd vaccine), PYREXIA (Fever 102F after 2nd vaccine) and CHILLS (Chills after 2nd vaccine) had resolved. At the time of the report, PERIPHERAL SWELLING (Swollen Right Foot after 2nd vaccine), PARAESTHESIA (Tingling in arms, feet and legs after 2nd vaccine) and HYPOAESTHESIA (Numbness in the arms, feet and legs after the 2nd vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Sep-2021, Body temperature: 102f (High) she had a Fever 102F.         No concomitant product was provided by the reporter. No treatment medication was provided.   This case was linked to MOD-2021-330949.   Reporter did not allow further contact
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Pyrexia
Clinical narrative: Sick after 2nd vaccine; Swollen Right Foot after 2nd vaccine; Tingling in arms, feet and legs after 2nd vaccine; Numbness in the arms, feet and legs after the 2nd vaccine; Fever 102F after 2nd vaccine; Chills after 2nd vaccine; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Sick after 2nd vaccine), PERIPHERAL SWELLING (Swollen Right Foot after 2nd vaccine), PARAESTHESIA (Tingling in arms, feet and legs after 2nd vaccine), HYPOAESTHESIA (Numbness in the arms, feet and legs after the 2nd vaccine) and PYREXIA (Fever 102F after 2nd vaccine) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   In August 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Sep-2021, the patient experienced MALAISE (Sick after 2nd vaccine), PERIPHERAL SWELLING (Swollen Right Foot after 2nd vaccine), PARAESTHESIA (Tingling in arms, feet and legs after 2nd vaccine), HYPOAESTHESIA (Numbness in the arms, feet and legs after the 2nd vaccine), PYREXIA (Fever 102F after 2nd vaccine) and CHILLS (Chills after 2nd vaccine). On 12-Sep-2021, MALAISE (Sick after 2nd vaccine), PYREXIA (Fever 102F after 2nd vaccine) and CHILLS (Chills after 2nd vaccine) had resolved. At the time of the report, PERIPHERAL SWELLING (Swollen Right Foot after 2nd vaccine), PARAESTHESIA (Tingling in arms, feet and legs after 2nd vaccine) and HYPOAESTHESIA (Numbness in the arms, feet and legs after the 2nd vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Sep-2021, Body temperature: 102f (High) she had a Fever 102F.         No concomitant product was provided by the reporter. No treatment medication was provided.   This case was linked to MOD-2021-330949.   Reporter did not allow further contact
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: He test results came back positive for Covid-19; Lack of drug effect; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 24-Sep-2021 and was forwarded to Moderna on 24-Sep-2021.    This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (He test results came back positive for Covid-19) and DRUG INEFFECTIVE (Lack of drug effect) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Sep-2021, the patient experienced SARS-COV-2 TEST POSITIVE (He test results came back positive for Covid-19) and DRUG INEFFECTIVE (Lack of drug effect). At the time of the report, SARS-COV-2 TEST POSITIVE (He test results came back positive for Covid-19) and DRUG INEFFECTIVE (Lack of drug effect) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Sep-2021, SARS-CoV-2 test: positive (Positive) Positive.         It was reported that patient has mild symptoms. No relevant concomitant medications were reported. No treatment information was reported.; Sender's Comments: This case concerns a 63-year-old male patient with no reported medical, who experienced SARS-CoV-2 test positive and Drug ineffective 3 months, 28 days after the second dose of Spikevax. The reporter did not provide causality assessment. The rechallenge was not applicable The benefit-risk relationship of Spikevax in not affected by this report.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: I just administered a First Moderna Covid-19 vaccine to a 16 year old; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (I just administered a First Moderna Covid-19 vaccine to a 16 year old) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020F21A) 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 24-Sep-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (I just administered a First Moderna Covid-19 vaccine to a 16 year old). On 24-Sep-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (I just administered a First Moderna Covid-19 vaccine to a 16 year old) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient did not complain of any other adverse events.   No concomitant medications were reported.  No treatment information was reported.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: sore left injection site arm after first vaccination; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore left injection site arm after first vaccination) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (On 28-FEB-2020 Patient experienced chest pain at that time and  Treatment received with Dr) in February 2020.    In May 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In May 2021, the patient experienced VACCINATION SITE PAIN (sore left injection site arm after first vaccination). At the time of the report, VACCINATION SITE PAIN (sore left injection site arm after first vaccination) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not reported.   This case was linked to MOD-2021-331229 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 2 doses of Covid Vaccine but as a mistake he was given the Sputnik and 3 months later the second dose of the Moderna; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2 doses of Covid Vaccine but as a mistake he was given the Sputnik and 3 months later the second dose of the Moderna) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2 doses of Covid Vaccine but as a mistake he was given the Sputnik and 3 months later the second dose of the Moderna). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2 doses of Covid Vaccine but as a mistake he was given the Sputnik and 3 months later the second dose of the Moderna) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported. No Treatment medications were reported.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Inappropriate schedule of product administration
Clinical narrative: Headache; Greater then 35 days between Covid-19 vaccinations; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Greater then 35 days between Covid-19 vaccinations) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Sep-2021, the patient experienced HEADACHE (Headache) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Greater then 35 days between Covid-19 vaccinations). On 24-Sep-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Greater then 35 days between Covid-19 vaccinations) had resolved. At the time of the report, HEADACHE (Headache) outcome was unknown.            No concomitant medications were reported No treatment information was reported.   This case was linked to MOD-2021-081668 (Patient Link).
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Muscle tightness, SARS-CoV-2 test, Vaccination site mass, Vaccination site pain
Clinical narrative: The left arm was tight where the lump was; Lump in the left arm where he received the shot; Left arm pain the area where he got the shot; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MUSCLE TIGHTNESS (The left arm was tight where the lump was), VACCINATION SITE MASS (Lump in the left arm where he received the shot) and VACCINATION SITE PAIN (Left arm pain the area where he got the shot) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A21A and 037B21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 02-Feb-2021. Concurrent medical conditions included Blood pressure abnormal, High cholesterol and Diabetes. Concomitant products included METFORMIN for an unknown indication.   On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-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 MUSCLE TIGHTNESS (The left arm was tight where the lump was), VACCINATION SITE MASS (Lump in the left arm where he received the shot) and VACCINATION SITE PAIN (Left arm pain the area where he got the shot). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency. At the time of the report, MUSCLE TIGHTNESS (The left arm was tight where the lump was) outcome was unknown, VACCINATION SITE MASS (Lump in the left arm where he received the shot) had resolved and VACCINATION SITE PAIN (Left arm pain the area where he got the shot) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered, Fatigue, Myalgia
Clinical narrative: Tired; Soreness in hand; 3rd dose administered to patient who is not immunocompromised; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Tired), MYALGIA (Soreness in hand) and EXTRA DOSE ADMINISTERED (3rd dose administered to patient who is not immunocompromised) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and 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 FATIGUE (Tired), MYALGIA (Soreness in hand) and EXTRA DOSE ADMINISTERED (3rd dose administered to patient who is not immunocompromised). At the time of the report, FATIGUE (Tired), MYALGIA (Soreness in hand) and EXTRA DOSE ADMINISTERED (3rd dose administered to patient who is not immunocompromised) outcome was unknown.            No concomitant product use was provided by the reporter. No treatment medication was provided. The 1st and 2nd dose 7 and a half months ago and 3rd dose administered 3 to 4 weeks ago
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Fall, Meniscus injury
Clinical narrative: slipped on ice; tore the meniscus in left knee; This spontaneous case was reported by a consumer and describes the occurrence of FALL (slipped on ice) and MENISCUS INJURY (tore the meniscus in left knee) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Knee meniscectomy in March 2021.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced FALL (slipped on ice) (seriousness criterion medically significant) and MENISCUS INJURY (tore the meniscus in left knee) (seriousness criterion medically significant). The patient was treated with Surgery (Left knee meniscus surgery in March 2021) for Meniscus injury. At the time of the report, FALL (slipped on ice) and MENISCUS INJURY (tore the meniscus in left knee) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. Treatment information was not provided. Case was assessed as serious as per reported seriousness in source document.  This case concerns a 68-year-old, male patient with no relevant medical history, who experienced the expected serious events of fall and meniscus injury. The events occurred approximately 15 days after the first dose of Spikevax. The rechallenge was negative   as the events did not recur after the second dose of the vaccine. The concurrent event of fall remains a confounder for meniscus injury. The benefit-risk relationship of Spikevax is not affected by this report.   This case was linked to MOD-2021-331173 (Patient Link).; Sender's Comments: This case concerns a 68-year-old, male patient with no relevant medical history, who experienced the expected serious events of fall and meniscus injury. The events occurred approximately 15 days after the first dose of Spikevax. The rechallenge was negative   as the events did not recur after the second dose of the vaccine. The concurrent event of fall remains a confounder for meniscus injury. The benefit-risk relationship of Spikevax is not affected by this report.
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: soreness of arm; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 24-Sep-2021 and was forwarded to Moderna on 24-Sep-2021.    This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (soreness of arm) in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A, 013L20A and 013L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MYALGIA (soreness of arm). At the time of the report, MYALGIA (soreness of arm) had resolved.            No concomitants medications was reported.  No treatments medications was reported.   This case was linked to MOD-2021-330997, MOD-2021-331146 (E2B Linked Report).; Sender's Comments:  MOD-2021-331146:Dose 3 case MOD-2021-330997:Dose 1 case
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Fatigue, Myalgia
Clinical narrative: sore arm; dizzy/light headed; weakness; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizzy/light headed), ASTHENIA (weakness), FATIGUE (fatigue) and MYALGIA (sore arm) in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039021A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Sep-2021, the patient experienced DIZZINESS (dizzy/light headed), ASTHENIA (weakness) and FATIGUE (fatigue). On an unknown date, the patient experienced MYALGIA (sore arm). At the time of the report, DIZZINESS (dizzy/light headed), ASTHENIA (weakness), FATIGUE (fatigue) and MYALGIA (sore arm) outcome was unknown.            This case was linked to MOD-2021-331145, MOD-2021-330997 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  MOD-2021-330997:Dose 1 case MOD-2021-331145:Dose 2 case
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: the arm was a little sore (3rd shot); This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (the arm was a little sore (3rd shot)) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 012M20A) for COVID-19 vaccination.     The patient's past medical history included Lung cancer. Concomitant products included ATORVASTATIN CALCIUM (LIPITOR), METOPROLOL SUCCINATE, AMLODIPINE, LOSARTAN POTASSIUM (LOSARTAN [LOSARTAN POTASSIUM]), ACETYLSALICYLIC ACID (ASPIRINE) and ESOMEPRAZOLE for an unknown indication.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Mar-2021, the patient experienced PAIN IN EXTREMITY (the arm was a little sore (3rd shot)). At the time of the report, PAIN IN EXTREMITY (the arm was a little sore (3rd shot)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medications reported.   This case was linked to MOD-2021-331310 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: report side effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (report side effects) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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 VACCINATION COMPLICATION (report side effects). At the time of the report, VACCINATION COMPLICATION (report side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.   No treatment information was provided.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: minor arm soreness; Minor bodyaches; This spontaneous case was reported by a physician and describes the occurrence of PAIN IN EXTREMITY (minor arm soreness) and PAIN (Minor bodyaches) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     Concurrent medical conditions included Chronic myeloid leukemia (blood work every six months; mutation remains low to zero) since 01-Oct-2014. Concomitant products included DASATINIB MONOHYDRATE (SPRYCEL) from 01-Dec-2014 to an unknown date for CML, AMLODIPINE BESYLATE from 01-Jan-2005 to an unknown date and LOSARTAN POTASSIUM from 31-Aug-2021 to an unknown date for Hypertension.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Jan-2021, the patient experienced PAIN IN EXTREMITY (minor arm soreness) and PAIN (Minor bodyaches). At the time of the report, PAIN IN EXTREMITY (minor arm soreness) and PAIN (Minor bodyaches) 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.   Treatment information was not provided.   This case was linked to MOD-2021-320005, MOD-2021-331218 (Patient Link).
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Hypertension, Myalgia, Tinnitus
Clinical narrative: severe ringing in ears; elevated blood pressure; minor arm sorness; minor body aches; This spontaneous case was reported by a physician and describes the occurrence of TINNITUS (severe ringing in ears), HYPERTENSION (elevated blood pressure) and MYALGIA (minor arm sorness; minor body aches) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     Concurrent medical conditions included Chronic myeloid leukemia (blood work every six months; mutation remains low to zero) since 10-Jan-2014. Concomitant products included LOSARTAN POTASSIUM from 31-Aug-2021 to an unknown date for Blood pressure increased, DASATINIB MONOHYDRATE (SPRYCEL) from 12-Jan-2014 to an unknown date for Chronic myeloid leukemia, AMLODIPINE BESYLATE from 01-Jan-2005 to an unknown date for Elevated blood pressure reading without diagnosis of hypertension.    On 27-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Feb-2021, the patient experienced TINNITUS (severe ringing in ears), HYPERTENSION (elevated blood pressure) and MYALGIA (minor arm sorness; minor body aches). At the time of the report, TINNITUS (severe ringing in ears), HYPERTENSION (elevated blood pressure) and MYALGIA (minor arm sorness; minor body aches) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered TINNITUS (severe ringing in ears), HYPERTENSION (elevated blood pressure) and MYALGIA (minor arm sorness; minor body aches) to be possibly related.    No treatment information was provided.   This case was linked to MOD-2021-320005, MOD-2021-331185 (Patient Link).
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Lymphadenopathy, Pyrexia, Vaccination site pain, Vaccination site swelling
Clinical narrative: Fever; Joint pain in arms and legs; arm is very sore and swollen on the top (injection site); arm is very sore and swollen on the top (injection site); Supraclavicular swelling, a lymph node is swollen; This spontaneous case was reported by an other health care professional and describes the occurrence of PYREXIA (Fever), ARTHRALGIA (Joint pain in arms and legs), VACCINATION SITE PAIN (arm is very sore and swollen on the top (injection site)), VACCINATION SITE SWELLING (arm is very sore and swollen on the top (injection site)) and LYMPHADENOPATHY (Supraclavicular swelling, a lymph node is swollen) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 012L20A) for COVID-19 vaccination.     The patient's past medical history included Viral infection NOS in March 2020. Concurrent medical conditions included Viral myocarditis (Cardiomyopathy) in June 2020 and Sleep disorder. Concomitant products included HYDROXYCHLOROQUINE, VITAMIN D NOS, FAMOTIDINE, VITAMIN B12 NOS (VITAMIN B 12 [VITAMIN B12 NOS]), FISH OIL and LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Sep-2021, the patient experienced PYREXIA (Fever), ARTHRALGIA (Joint pain in arms and legs), VACCINATION SITE PAIN (arm is very sore and swollen on the top (injection site)), VACCINATION SITE SWELLING (arm is very sore and swollen on the top (injection site)) and LYMPHADENOPATHY (Supraclavicular swelling, a lymph node is swollen). The patient was treated with HYDROXYCHLOROQUINE SULFATE (PLAQUENIL [HYDROXYCHLOROQUINE SULFATE]) for Tendinitis, at an unspecified dose and frequency and SULFASALAZINE ongoing from March 2021 for Tendinitis, at an unspecified dose and frequency. At the time of the report, PYREXIA (Fever), ARTHRALGIA (Joint pain in arms and legs), VACCINATION SITE PAIN (arm is very sore and swollen on the top (injection site)), VACCINATION SITE SWELLING (arm is very sore and swollen on the top (injection site)) and LYMPHADENOPATHY (Supraclavicular swelling, a lymph node is swollen) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patients concomitant medications include Medication for sleep disorder.  Lot number for 3rd dose of the vaccine reported as 0 (4 or 7) (5 or S) C21A.  The patient used ice.   This case was linked to MOD-2021-331260, MOD-2021-331212 (Patient Link).
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: Vertigo which got worse after the shot; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (Vertigo which got worse after the shot) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Feb-2021, the patient experienced VERTIGO (Vertigo which got worse after the shot). At the time of the report, VERTIGO (Vertigo which got worse after the shot) outcome was unknown.            No concomitant medications were reported No treatment medications were  reported   This case was linked to MOD-2021-331252 (Patient Link).
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Urine output increased, Vaccination complication
Clinical narrative: Not feeling well after the second vaccine; Urinated a lot after the second vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Not feeling well after the second vaccine) and URINE OUTPUT INCREASED (Urinated a lot after the second vaccine) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Apr-2021, the patient experienced VACCINATION COMPLICATION (Not feeling well after the second vaccine) and URINE OUTPUT INCREASED (Urinated a lot after the second vaccine). On 15-Apr-2021, VACCINATION COMPLICATION (Not feeling well after the second vaccine) and URINE OUTPUT INCREASED (Urinated a lot after the second vaccine) had resolved.            No concomitant drugs were reported. No treatment drugs were reported.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Arthritis, Pain, Somnolence
Clinical narrative: the arthritis was painful; slept for 12 hours; very very achy; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRITIS (the arthritis was painful), SOMNOLENCE (slept for 12 hours) and PAIN (very very achy) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A, 012M20A and 046C21A) for COVID-19 vaccination.     Concurrent medical conditions included Lung cancer. Concomitant products included ATORVASTATIN CALCIUM (LIPITOR), METOPROLOL SUCCINATE, AMLODIPINE, LOSARTAN, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) and ESOMEPRAZOLE for an unknown indication.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Mar-2021, the patient experienced ARTHRITIS (the arthritis was painful), SOMNOLENCE (slept for 12 hours) and PAIN (very very achy). The patient was treated with HYDROCODONE BITARTRATE, PARACETAMOL (VICODIN) at a dose of Vicodin 10/325mg took maybe 1/2 to a 1. At the time of the report, ARTHRITIS (the arthritis was painful), SOMNOLENCE (slept for 12 hours) and PAIN (very very achy) was resolving.            This case was linked to MOD-2021-331149 (Patient Link).; Sender's Comments: This case concerns a 73-year-old, male patient with medical history of lung cancer, who experienced the unexpected non-serious adverse event of special interest of arthritis. The event occurred on the same day after the second dose of Spikevax (Moderna COVID-19 vaccine. The rechallenge was negative since the patient recovered from the event and then received the third dose without recurrence. The medical history of lung cancer remains and negative rechallenge remains as a potential confounder. The benefit-risk relationship of Spikevax (Moderna COVID-19 vaccine) is not affected by this report.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Headache, Pyrexia
Clinical narrative: fever (102°F); Fatigue; headache; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever (102°F)), FATIGUE (Fatigue) and HEADACHE (headache) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     Concomitant products included PARACETAMOL (TYLENOL) for Adverse event.    On 24-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Sep-2021, the patient experienced PYREXIA (fever (102°F)), FATIGUE (Fatigue) and HEADACHE (headache). At the time of the report, PYREXIA (fever (102°F)), FATIGUE (Fatigue) and HEADACHE (headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Sep-2021, Body temperature: 102 (High) (102°F)High.         No treatment information were reported.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Epistaxis, Hypertension
Clinical narrative: Nose bleeding; high blood pressure; This spontaneous case was reported by a consumer and describes the occurrence of EPISTAXIS (Nose bleeding) and HYPERTENSION (high blood pressure) 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 EPISTAXIS (Nose bleeding) and HYPERTENSION (high blood pressure). At the time of the report, EPISTAXIS (Nose bleeding) and HYPERTENSION (high blood pressure) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product used was not provided by the reporter. Treatment medication used was not provided by the reporter.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Injection site erythema, Injection site pruritus, Malaise, Pain
Clinical narrative: Feel weak; Feel sick; it started to swell up below the injection site in a lemon sized lump; little red circles; Sarted itching like crazy; This area continued to stay swollen and itchy; Pain in patient's arm which worsened; This spontaneous case was reported by a patient and describes the occurrence of PAIN (Pain in patient's arm which worsened), ASTHENIA (Feel weak), MALAISE (Feel sick), VACCINATION SITE MASS (it started to swell up below the injection site in a lemon sized lump) and INJECTION SITE ERYTHEMA (little red circles) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 061E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 21-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Sep-2021, the patient experienced PAIN (Pain in patient's arm which worsened). On 22-Sep-2021, the patient experienced ASTHENIA (Feel weak), MALAISE (Feel sick), VACCINATION SITE MASS (it started to swell up below the injection site in a lemon sized lump), INJECTION SITE ERYTHEMA (little red circles), INJECTION SITE PRURITUS (Sarted itching like crazy) and VACCINATION SITE SWELLING (This area continued to stay swollen and itchy). The patient was treated with NAPROXEN SODIUM (ALEVE) for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN (Pain in patient's arm which worsened), ASTHENIA (Feel weak), MALAISE (Feel sick), VACCINATION SITE MASS (it started to swell up below the injection site in a lemon sized lump), INJECTION SITE ERYTHEMA (little red circles), INJECTION SITE PRURITUS (Sarted itching like crazy) and VACCINATION SITE SWELLING (This area continued to stay swollen and itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided by reporter.