chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Nausea, Vaccination site erythema
Clinical narrative: Lot of redness around the injection site; Really tired; Nauseous; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Lot of redness around the injection site), FATIGUE (Really tired) and NAUSEA (Nauseous) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (Lot of redness around the injection site), FATIGUE (Really tired) and NAUSEA (Nauseous). At the time of the report, VACCINATION SITE ERYTHEMA (Lot of redness around the injection site), FATIGUE (Really tired) and NAUSEA (Nauseous) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.  No treatment details were provided.
Sex: F
Vaccine: COVID19
Symptoms: Arthritis
Clinical narrative: Arthritic swelling in her finger; This spontaneous case was reported by a pharmacist and describes the occurrence of ARTHRITIS (Arthritic swelling in her finger) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ARTHRITIS (Arthritic swelling in her finger). At the time of the report, ARTHRITIS (Arthritic swelling in her finger) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not provided.   Treatment information was not provided.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Myalgia, Pain in extremity, Paraesthesia, Vaccination site rash
Clinical narrative: pain radiated down to her fingers; tingled; arm feels heavy; arm hurt and was sore,feels like a cinderblock is on the top art of her arm that feels painful; rash on arm at Vaccination site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain radiated down to her fingers), PARAESTHESIA (tingled), LIMB DISCOMFORT (arm feels heavy), MYALGIA (arm hurt and was sore,feels like a cinderblock is on the top art of her arm that feels painful) and VACCINATION SITE RASH (rash on arm at Vaccination site) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032B21A and 037A21B) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-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 PAIN IN EXTREMITY (pain radiated down to her fingers), PARAESTHESIA (tingled), LIMB DISCOMFORT (arm feels heavy), MYALGIA (arm hurt and was sore,feels like a cinderblock is on the top art of her arm that feels painful) and VACCINATION SITE RASH (rash on arm at Vaccination site). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (pain radiated down to her fingers), PARAESTHESIA (tingled), LIMB DISCOMFORT (arm feels heavy), MYALGIA (arm hurt and was sore,feels like a cinderblock is on the top art of her arm that feels painful) and VACCINATION SITE RASH (rash on arm at Vaccination site) outcome was unknown.            No concomitant medications reported.   Treatment information not reported.   This case was linked to MOD-2021-213379 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia, Pyrexia
Clinical narrative: feel tired; headache; fever; arm is sore; 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 FATIGUE (feel tired), HEADACHE (headache), PYREXIA (fever) and MYALGIA (arm is sore) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (feel tired), HEADACHE (headache), PYREXIA (fever) and MYALGIA (arm is sore). At the time of the report, FATIGUE (feel tired), HEADACHE (headache), PYREXIA (fever) and MYALGIA (arm is sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided  No treatment medications were reported
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Injection site rash, Pain, Pain in extremity, Paraesthesia
Clinical narrative: arm hurt and was sore/ feels like a cinderblock is on the top art of her arm that feels heavy and painful; pain radiated down to her fingers; tingled; sluggish; fatigued; rash on arm at injection site; This spontaneous case was reported by a patient and describes the occurrence of SLUGGISHNESS (sluggish), FATIGUE (fatigued), INJECTION SITE RASH (rash on arm at injection site), PAIN IN EXTREMITY (arm hurt and was sore/ feels like a cinderblock is on the top art of her arm that feels heavy and painful) and PAIN (pain radiated down to her fingers) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032B21A and 037A21B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SLUGGISHNESS (sluggish), FATIGUE (fatigued), INJECTION SITE RASH (rash on arm at injection site), PAIN IN EXTREMITY (arm hurt and was sore/ feels like a cinderblock is on the top art of her arm that feels heavy and painful), PAIN (pain radiated down to her fingers) and PARAESTHESIA (tingled). At the time of the report, SLUGGISHNESS (sluggish), FATIGUE (fatigued), INJECTION SITE RASH (rash on arm at injection site), PAIN IN EXTREMITY (arm hurt and was sore/ feels like a cinderblock is on the top art of her arm that feels heavy and painful), PAIN (pain radiated down to her fingers) and PARAESTHESIA (tingled) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable.  Treatment information was not provided. Concomitant product use was not provided.    This case was linked to MOD-2021-213373 (Patient Link).
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Sluggishness
Clinical narrative: arm hurt and was sore/ feels like a cinderblock is on the top art of her arm that feels heavy and painful; pain radiated down to her fingers; tingled; sluggish; fatigued; rash on arm at injection site; This spontaneous case was reported by a patient and describes the occurrence of SLUGGISHNESS (sluggish), FATIGUE (fatigued), INJECTION SITE RASH (rash on arm at injection site), PAIN IN EXTREMITY (arm hurt and was sore/ feels like a cinderblock is on the top art of her arm that feels heavy and painful) and PAIN (pain radiated down to her fingers) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032B21A and 037A21B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SLUGGISHNESS (sluggish), FATIGUE (fatigued), INJECTION SITE RASH (rash on arm at injection site), PAIN IN EXTREMITY (arm hurt and was sore/ feels like a cinderblock is on the top art of her arm that feels heavy and painful), PAIN (pain radiated down to her fingers) and PARAESTHESIA (tingled). At the time of the report, SLUGGISHNESS (sluggish), FATIGUE (fatigued), INJECTION SITE RASH (rash on arm at injection site), PAIN IN EXTREMITY (arm hurt and was sore/ feels like a cinderblock is on the top art of her arm that feels heavy and painful), PAIN (pain radiated down to her fingers) and PARAESTHESIA (tingled) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable.  Treatment information was not provided. Concomitant product use was not provided.    This case was linked to MOD-2021-213373 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Vaccination adverse reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Vaccination adverse reaction) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Vaccination adverse reaction). At the time of the report, VACCINATION COMPLICATION (Vaccination adverse reaction) outcome was unknown.        Action taken with mRNA-1273 in response to the events was not applicable No treatment information and concomitant medications were provided   This case was linked to MOD-2021-213355, MOD-2021-213355 (Patient Link).
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure fluctuation, Blood pressure measurement, Electrocardiogram, Heart rate, Myalgia
Clinical narrative: Blood pressure continue to go up and down; sore on area of vaccine shot; Slight fever lasted 3 hours; Body ache; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE FLUCTUATION (Blood pressure continue to go up and down), VACCINATION SITE PAIN (sore on area of vaccine shot), PYREXIA (Slight fever lasted 3 hours) and MYALGIA (Body ache) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041C21A and 004C21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Aspirin allergy). Concomitant products included VITAMIN C [ASCORBIC ACID] and FISH OIL for an unknown indication.   On 04-May-2021 at 5:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Jun-2021 at 5:45 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Jun-2021, the patient experienced BLOOD PRESSURE FLUCTUATION (Blood pressure continue to go up and down), VACCINATION SITE PAIN (sore on area of vaccine shot), PYREXIA (Slight fever lasted 3 hours) and MYALGIA (Body ache). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at a dose of 1 dosage form; HYDROCHLOROTHIAZIDE (HYDROCHOROTHIAZIDE) (oral) on 05-May-2021 at a dose of 25 milligram and CLONIDINE HCL on 05-May-2021 at a dose of 0.2 milligram. At the time of the report, BLOOD PRESSURE FLUCTUATION (Blood pressure continue to go up and down) outcome was unknown and VACCINATION SITE PAIN (sore on area of vaccine shot), PYREXIA (Slight fever lasted 3 hours) and MYALGIA (Body ache) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-May-2021, Blood pressure measurement: 157/101 (Inconclusive) at 10:25AM, 157/93 (Inconclusive) at 10:50AM and 165/103 (Inconclusive) at 12:13PM. On 05-May-2021, Electrocardiogram: unknown (Inconclusive) at 1:30PM. On 05-May-2021, Heart rate: 61 Inconclusive, 63 Inconclusive and 70 Inconclusive. On 05-May-2021, X-ray: unknown (Inconclusive) at 1:30PM.         The action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-106771, MOD-2021-106771 (Patient Link).
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain, X-ray
Clinical narrative: Blood pressure continue to go up and down; sore on area of vaccine shot; Slight fever lasted 3 hours; Body ache; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE FLUCTUATION (Blood pressure continue to go up and down), VACCINATION SITE PAIN (sore on area of vaccine shot), PYREXIA (Slight fever lasted 3 hours) and MYALGIA (Body ache) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041C21A and 004C21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Aspirin allergy). Concomitant products included VITAMIN C [ASCORBIC ACID] and FISH OIL for an unknown indication.   On 04-May-2021 at 5:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Jun-2021 at 5:45 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Jun-2021, the patient experienced BLOOD PRESSURE FLUCTUATION (Blood pressure continue to go up and down), VACCINATION SITE PAIN (sore on area of vaccine shot), PYREXIA (Slight fever lasted 3 hours) and MYALGIA (Body ache). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at a dose of 1 dosage form; HYDROCHLOROTHIAZIDE (HYDROCHOROTHIAZIDE) (oral) on 05-May-2021 at a dose of 25 milligram and CLONIDINE HCL on 05-May-2021 at a dose of 0.2 milligram. At the time of the report, BLOOD PRESSURE FLUCTUATION (Blood pressure continue to go up and down) outcome was unknown and VACCINATION SITE PAIN (sore on area of vaccine shot), PYREXIA (Slight fever lasted 3 hours) and MYALGIA (Body ache) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-May-2021, Blood pressure measurement: 157/101 (Inconclusive) at 10:25AM, 157/93 (Inconclusive) at 10:50AM and 165/103 (Inconclusive) at 12:13PM. On 05-May-2021, Electrocardiogram: unknown (Inconclusive) at 1:30PM. On 05-May-2021, Heart rate: 61 Inconclusive, 63 Inconclusive and 70 Inconclusive. On 05-May-2021, X-ray: unknown (Inconclusive) at 1:30PM.         The action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-106771, MOD-2021-106771 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Patient had the first dose from Moderna and the second dose from Pfizer; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Patient had the first dose from Moderna and the second dose from Pfizer) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Patient had the first dose from Moderna and the second dose from Pfizer). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (Patient had the first dose from Moderna and the second dose from Pfizer) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication information was provided. No treatment medication information was provided.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Product dose omission issue, SARS-CoV-2 test
Clinical narrative: tested positive   few weeks after  receiving first dose of Moderna Covid-19 Vaccine; second dose on 26th Jan2021 but could not take due to the covid-19 infection; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive   few weeks after  receiving first dose of Moderna Covid-19 Vaccine) and PRODUCT DOSE OMISSION ISSUE (second dose on 26th Jan2021 but could not take due to the covid-19 infection) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure fluctuation.    On 27-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (tested positive   few weeks after  receiving first dose of Moderna Covid-19 Vaccine) and PRODUCT DOSE OMISSION ISSUE (second dose on 26th Jan2021 but could not take due to the covid-19 infection). At the time of the report, COVID-19 (tested positive   few weeks after  receiving first dose of Moderna Covid-19 Vaccine) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (second dose on 26th Jan2021 but could not take due to the covid-19 infection) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, SARS-CoV-2 test: positive (Positive) tested positive few weeks after receiving first dose of Moderna Covid-19 Vaccine.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product include unspecified blood pressure pill.  No treatment medications provided by the reporter.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient took the second dose past the 42 days mark; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient took the second dose past the 42 days mark) in an 18-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 034C21A and 002C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Jun-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient took the second dose past the 42 days mark). On 08-Jun-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient took the second dose past the 42 days mark) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  No treatment information was provided.  The patient received both scheduled doses of mRNA-1273 prior to the events therefore, action taken with the drug in response to the events was not applicable.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Feeling abnormal, Malaise, Nausea, Poor quality sleep
Clinical narrative: Felt terrible / Felt raunchy; Did not get back to normal; Sleep Restless; feeling very bloated; Bit nauseous; Vomitting; Slightly elevated fever; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Felt terrible / Felt raunchy), MALAISE (Did not get back to normal), POOR QUALITY SLEEP (Sleep Restless), ABDOMINAL DISTENSION (feeling very bloated) and NAUSEA (Bit nauseous) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma, Irritable bowel syndrome, Osteoporosis and Drug allergy (Cipro). Concomitant products included MONTELUKAST for Allergy, FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for Asthma, ATORVASTATIN for Cholesterol, OPIUM TINCTURE for Irritable bowel syndrome.   On 10-Feb-2021 at 9:15 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021 at 9:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Mar-2021, the patient experienced FEELING ABNORMAL (Felt terrible / Felt raunchy), MALAISE (Did not get back to normal), POOR QUALITY SLEEP (Sleep Restless), ABDOMINAL DISTENSION (feeling very bloated), NAUSEA (Bit nauseous), VOMITING (Vomitting) and PYREXIA (Slightly elevated fever). At the time of the report, FEELING ABNORMAL (Felt terrible / Felt raunchy), MALAISE (Did not get back to normal), POOR QUALITY SLEEP (Sleep Restless), ABDOMINAL DISTENSION (feeling very bloated), NAUSEA (Bit nauseous), VOMITING (Vomitting) and PYREXIA (Slightly elevated fever) had resolved.            Concomitant medication Vitamin D  was reported.  Treatment drug information was not given.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jul-2021: Significant follow-up received update patient history, updated suspect drug dosage regimen, added concomitant drugs and new event added restless sleep and updated medical history and outcome of events
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: Felt terrible / Felt raunchy; Did not get back to normal; Sleep Restless; feeling very bloated; Bit nauseous; Vomitting; Slightly elevated fever; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Felt terrible / Felt raunchy), MALAISE (Did not get back to normal), POOR QUALITY SLEEP (Sleep Restless), ABDOMINAL DISTENSION (feeling very bloated) and NAUSEA (Bit nauseous) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma, Irritable bowel syndrome, Osteoporosis and Drug allergy (Cipro). Concomitant products included MONTELUKAST for Allergy, FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for Asthma, ATORVASTATIN for Cholesterol, OPIUM TINCTURE for Irritable bowel syndrome.   On 10-Feb-2021 at 9:15 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021 at 9:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Mar-2021, the patient experienced FEELING ABNORMAL (Felt terrible / Felt raunchy), MALAISE (Did not get back to normal), POOR QUALITY SLEEP (Sleep Restless), ABDOMINAL DISTENSION (feeling very bloated), NAUSEA (Bit nauseous), VOMITING (Vomitting) and PYREXIA (Slightly elevated fever). At the time of the report, FEELING ABNORMAL (Felt terrible / Felt raunchy), MALAISE (Did not get back to normal), POOR QUALITY SLEEP (Sleep Restless), ABDOMINAL DISTENSION (feeling very bloated), NAUSEA (Bit nauseous), VOMITING (Vomitting) and PYREXIA (Slightly elevated fever) had resolved.            Concomitant medication Vitamin D  was reported.  Treatment drug information was not given.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jul-2021: Significant follow-up received update patient history, updated suspect drug dosage regimen, added concomitant drugs and new event added restless sleep and updated medical history and outcome of events
Age: 45.0
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Interchange of vaccine products
Clinical narrative: received first dose of Astra Zeneca covid-19 vaccine and second dose of Moderna Covid-19; first dose of astra zeneca covid 19 vaccine in 03April2021,The patient received second dose of Moderna Covid-19 vaccine today, 08June2021; This spontaneous case was reported by a nurse and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (received first dose of Astra Zeneca covid-19 vaccine and second dose of Moderna Covid-19) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose of astra zeneca covid 19 vaccine in 03April2021,The patient received second dose of Moderna Covid-19 vaccine today, 08June2021) in a 45-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Jun-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (received first dose of Astra Zeneca covid-19 vaccine and second dose of Moderna Covid-19) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose of astra zeneca covid 19 vaccine in 03April2021,The patient received second dose of Moderna Covid-19 vaccine today, 08June2021). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (received first dose of Astra Zeneca covid-19 vaccine and second dose of Moderna Covid-19) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose of astra zeneca covid 19 vaccine in 03April2021,The patient received second dose of Moderna Covid-19 vaccine today, 08June2021) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported.  No treatment information provided.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenopia, Feeling abnormal, Headache, Hyperhidrosis
Clinical narrative: forehead is a little abnormally sweaty; "eyes feel heavy like I'm under medication"; "I have a headache trying to come on"; "it just felt weird"; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (forehead is a little abnormally sweaty), ASTHENOPIA ("eyes feel heavy like I'm under medication"), HEADACHE ("I have a headache trying to come on") and FEELING ABNORMAL ("it just felt weird") in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Jun-2021, the patient experienced HYPERHIDROSIS (forehead is a little abnormally sweaty), ASTHENOPIA ("eyes feel heavy like I'm under medication"), HEADACHE ("I have a headache trying to come on") and FEELING ABNORMAL ("it just felt weird"). At the time of the report, HYPERHIDROSIS (forehead is a little abnormally sweaty), ASTHENOPIA ("eyes feel heavy like I'm under medication"), HEADACHE ("I have a headache trying to come on") and FEELING ABNORMAL ("it just felt weird") outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable.  Treatment information was not provided. Concomitant product use was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Induration, Peripheral swelling
Clinical narrative: I developed a large hard lump in my armpit of the arm; large hard lump; 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 PERIPHERAL SWELLING (I developed a large hard lump in my armpit of the arm) and INDURATION (large hard lump) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (I developed a large hard lump in my armpit of the arm) and INDURATION (large hard lump). At the time of the report, PERIPHERAL SWELLING (I developed a large hard lump in my armpit of the arm) and INDURATION (large hard lump) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment drug information provided. No concomitant drug information provided.   Reporter did not allow further contact
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Peripheral swelling, Rash, Somnolence
Clinical narrative: Swelling arm; Sleepy / sleepy since March; Arm hurts; Rash broken out / rash broke out on my arm; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swelling arm), SOMNOLENCE (Sleepy / sleepy since March), MYALGIA (Arm hurts) and RASH (Rash broken out / rash broke out on my arm) in a 70-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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (Swelling arm), SOMNOLENCE (Sleepy / sleepy since March), MYALGIA (Arm hurts) and RASH (Rash broken out / rash broke out on my arm). At the time of the report, PERIPHERAL SWELLING (Swelling arm), SOMNOLENCE (Sleepy / sleepy since March), MYALGIA (Arm hurts) and RASH (Rash broken out / rash broke out on my arm) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The concomitant information was not provided.  The treatment information was not provided.       Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2021: Non significant follow up appended On 10-Jun-2021: Non-significant follow-up
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Feeling abnormal, Muscle discomfort, Musculoskeletal discomfort, Oestradiol
Clinical narrative: muscle discomfort; a couple joint's discomfort; my game's been off a little; This spontaneous case was reported by a non-health professional and describes the occurrence of MUSCLE DISCOMFORT (muscle discomfort), MUSCULOSKELETAL DISCOMFORT (a couple joint's discomfort) and FEELING ABNORMAL (my game's been off a little) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A and 040A21A) 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 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Apr-2021, the patient experienced MUSCLE DISCOMFORT (muscle discomfort), MUSCULOSKELETAL DISCOMFORT (a couple joint's discomfort) and FEELING ABNORMAL (my game's been off a little). On 12-Apr-2021, MUSCLE DISCOMFORT (muscle discomfort), MUSCULOSKELETAL DISCOMFORT (a couple joint's discomfort) and FEELING ABNORMAL (my game's been off a little) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-May-2021, Blood pressure measurement: increased (High) increased. On 12-May-2021, Oestradiol: 99 (Inconclusive) 99 pd/ml. On an unknown date, Oestradiol:.         Concomitant medication use includes a statin (specific drug and indication not further specified).  It was noted that the patient has had normal CCK and Thyroid levels (dates not provided). Following his lab appointment on 12May2021, the patient had his estradiol rechecked on 23May2021 and was found to be basically in the same range.  Also during a doctor's visit around the beginning of June, the patient had a spurt of blood pressure which he attributes to whitecoat and is a usual occurrence for him.   Treatment information was not provided.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Product dose omission issue, SARS-CoV-2 test
Clinical narrative: scheduled to take their second dose on 26th Jan2021 but could not; tested positive few weeks after receiving first dose of Moderna Covid-19 Vaccine; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive few weeks after receiving first dose of Moderna Covid-19 Vaccine) and PRODUCT DOSE OMISSION ISSUE (scheduled to take their second dose on 26th Jan2021 but could not) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes, Heart disease, unspecified and Cholesterol.    On 27-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Dec-2020, the patient experienced COVID-19 (tested positive few weeks after receiving first dose of Moderna Covid-19 Vaccine). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (scheduled to take their second dose on 26th Jan2021 but could not). At the time of the report, COVID-19 (tested positive few weeks after receiving first dose of Moderna Covid-19 Vaccine) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (scheduled to take their second dose on 26th Jan2021 but could not) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication included Diabetes pills, Heart pills, water pill, Cholesterol medication, not otherwise specified.  No treatment details were provided.   This case was linked to MOD-2021-213385 (E2B Linked Report).; Sender's Comments:  MOD-2021-213385:MOD-2021-213385 (WifeCase)
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: felt like crap for a month / had weird symptoms for a month straight; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt like crap for a month / had weird symptoms for a month straight) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (felt like crap for a month / had weird symptoms for a month straight). At the time of the report, FEELING ABNORMAL (felt like crap for a month / had weird symptoms for a month straight) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product information was not provided. Treatment information was not provided.   This case was linked to MOD-2021-213477 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: I was vaccinated and still got COVID-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (I was vaccinated and still got COVID-19) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (I was vaccinated and still got COVID-19). At the time of the report, COVID-19 (I was vaccinated and still got COVID-19) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.   Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site mass
Clinical narrative: Is it normal to have a ball where you got the vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE MASS (Is it normal to have a ball where you got the vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE MASS (Is it normal to have a ball where you got the vaccine). At the time of the report, VACCINATION SITE MASS (Is it normal to have a ball where you got the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. No treatment details were provided.
Sex: U
Vaccine: COVID19
Symptoms: Pityriasis rubra pilaris
Clinical narrative: Pityriasis rubra pilaris; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of PITYRIASIS RUBRA PILARIS (Pityriasis rubra pilaris) 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.    In March 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PITYRIASIS RUBRA PILARIS (Pityriasis rubra pilaris). At the time of the report, PITYRIASIS RUBRA PILARIS (Pityriasis rubra pilaris) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information was provided. No relevant concomitant medications were reported. The patient did not receive any treatment. Lab details were not provided.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Hypersomnia, Inappropriate schedule of product administration, SARS-CoV-2 test
Clinical narrative: weakness; could not receive the second dose for 90 days after the infusion; sleep alot; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weakness), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (could not receive the second dose for 90 days after the infusion), HYPERSOMNIA (sleep alot) and FATIGUE (fatigue) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ASTHENIA (weakness), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (could not receive the second dose for 90 days after the infusion), HYPERSOMNIA (sleep alot) and FATIGUE (fatigue). At the time of the report, ASTHENIA (weakness), HYPERSOMNIA (sleep alot) and FATIGUE (fatigue) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (could not receive the second dose for 90 days after the infusion) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Apr-2021, SARS-CoV-2 test: positive (Positive) tested positive for COVID-19.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported.  The patient received antibody infusion (not specified) on 12-Apr-2021 for treatment of COVID-19.  For mRNA-1273 (COVID 19 Vaccine Moderna), the reporter did not provide any causality assessments.    This case was linked to MOD21-108548 (E2B Linked Report).; Sender's Comments:  MOD21-108548:MOD21-108548 (husband case)
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Myalgia
Clinical narrative: Spasm on the opposite arm of injection site (left arm); Pain on the opposite arm of injection site (left arm); This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 09-Jun-2021 and was forwarded to Moderna on 09-Jun-2021.    This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 09-Jun-2021 and was forwarded to Moderna on 09-Jun-2021.    This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (Spasm on the opposite arm of injection site (left arm)) and MYALGIA (Pain on the opposite arm of injection site (left arm)) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO) and BUPRENORPHINE for an unknown indication.    On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jun-2021, the patient experienced MUSCLE SPASMS (Spasm on the opposite arm of injection site (left arm)) and MYALGIA (Pain on the opposite arm of injection site (left arm)). At the time of the report, MUSCLE SPASMS (Spasm on the opposite arm of injection site (left arm)) and MYALGIA (Pain on the opposite arm of injection site (left arm)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Dermatitis contact, Feeling abnormal, Therapeutic response unexpected
Clinical narrative: presence of poison ivy rash with no itching; off-label benefit from receiving the Moderna COVID-19 Vaccine; felt crappy/dragging; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (off-label benefit from receiving the Moderna COVID-19 Vaccine), DERMATITIS CONTACT (presence of poison ivy rash with no itching) and FEELING ABNORMAL (felt crappy/dragging) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 026L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Previously administered products included for an unreported indication: STEROIDS (high dose steroids generally used to treat the allergic reaction to poison ivy). Concurrent medical conditions included Allergy to plants (severe allergic reaction to poison ivy - has occurred off and on for 35 years). Concomitant products included BORAGO OFFICINALIS OIL, FISH OIL, LINUM USITATISSIMUM OIL (3 OMEGAS), ESOMEPRAZOLE, MAGNESIUM, MULTIVITAMINS [VITAMINS NOS], COLECALCIFEROL (VITAMIN D3), UBIDECARENONE (CO Q10) and ASCORBIC ACID (VIT C) for an unknown indication.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Feb-2021, the patient experienced FEELING ABNORMAL (felt crappy/dragging). On an unknown date, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (off-label benefit from receiving the Moderna COVID-19 Vaccine) and DERMATITIS CONTACT (presence of poison ivy rash with no itching). On 14-Feb-2021, FEELING ABNORMAL (felt crappy/dragging) had resolved. At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (off-label benefit from receiving the Moderna COVID-19 Vaccine) had resolved and DERMATITIS CONTACT (presence of poison ivy rash with no itching) outcome was unknown.            Treatment information not reported.   This case was linked to MOD-2021-213441 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus
Clinical narrative: itching at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (itching at injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PRURITUS (itching at injection site). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and CORTISONE at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PRURITUS (itching at injection site) 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.