chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 17.0
Sex: U
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 17 year old received the vaccine; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old received the vaccine) in a 17-year-old patient of an unknown 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 PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old received the vaccine). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old received the vaccine) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Treatment medication was not provided by the reporter.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: An inmate received a third dose of the Moderna COVID-19 Vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXTRA DOSE ADMINISTERED (An inmate received a third dose of the Moderna COVID-19 Vaccine) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025J20-2A, 025J20-2A and 047B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LEVETIRACETAM (KEPPRA XR), TAMSULOSIN HYDROCHLORIDE (FLOMAX RELIEF), ZONISAMIDE, IBUPROFEN and OXCARBAZEPINE (TRILEPTAL) for an unknown indication.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Apr-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Apr-2021, the patient experienced EXTRA DOSE ADMINISTERED (An inmate received a third dose of the Moderna COVID-19 Vaccine). On 28-Apr-2021, EXTRA DOSE ADMINISTERED (An inmate received a third dose of the Moderna COVID-19 Vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature fluctuation, Chills, Dizziness, Feeling cold, Headache
Clinical narrative: Sweat through sheets and different outfits; Body temperature still not regulated; Freezing cold; Arm looks like a goose egg, inflamed, and has a big bump; Dizziness; Super bad headache; Starting at midnight,he was physically shaking because he was so cold; Fever all night; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Sweat through sheets and different outfits), BODY TEMPERATURE FLUCTUATION (Body temperature still not regulated), FEELING COLD (Freezing cold), PERIPHERAL SWELLING (Arm looks like a goose egg, inflamed, and has a big bump) and DIZZINESS (Dizziness) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 05-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPERHIDROSIS (Sweat through sheets and different outfits), BODY TEMPERATURE FLUCTUATION (Body temperature still not regulated), FEELING COLD (Freezing cold), PERIPHERAL SWELLING (Arm looks like a goose egg, inflamed, and has a big bump), DIZZINESS (Dizziness), HEADACHE (Super bad headache), CHILLS (Starting at midnight,he was physically shaking because he was so cold) and PYREXIA (Fever all night). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and ELECTROLYTES NOS, GLUCOSE (PEDIALYTE [ELECTROLYTES NOS;GLUCOSE]) at an unspecified dose and frequency. At the time of the report, HYPERHIDROSIS (Sweat through sheets and different outfits), BODY TEMPERATURE FLUCTUATION (Body temperature still not regulated), FEELING COLD (Freezing cold), PERIPHERAL SWELLING (Arm looks like a goose egg, inflamed, and has a big bump), DIZZINESS (Dizziness), HEADACHE (Super bad headache), CHILLS (Starting at midnight,he was physically shaking because he was so cold) and PYREXIA (Fever all night) had not resolved.            No concomitant medications provided.  Patient was given water for hydration.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis, Peripheral swelling, Pyrexia
Clinical narrative: Sweat through sheets and different outfits; Body temperature still not regulated; Freezing cold; Arm looks like a goose egg, inflamed, and has a big bump; Dizziness; Super bad headache; Starting at midnight,he was physically shaking because he was so cold; Fever all night; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Sweat through sheets and different outfits), BODY TEMPERATURE FLUCTUATION (Body temperature still not regulated), FEELING COLD (Freezing cold), PERIPHERAL SWELLING (Arm looks like a goose egg, inflamed, and has a big bump) and DIZZINESS (Dizziness) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 05-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPERHIDROSIS (Sweat through sheets and different outfits), BODY TEMPERATURE FLUCTUATION (Body temperature still not regulated), FEELING COLD (Freezing cold), PERIPHERAL SWELLING (Arm looks like a goose egg, inflamed, and has a big bump), DIZZINESS (Dizziness), HEADACHE (Super bad headache), CHILLS (Starting at midnight,he was physically shaking because he was so cold) and PYREXIA (Fever all night). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and ELECTROLYTES NOS, GLUCOSE (PEDIALYTE [ELECTROLYTES NOS;GLUCOSE]) at an unspecified dose and frequency. At the time of the report, HYPERHIDROSIS (Sweat through sheets and different outfits), BODY TEMPERATURE FLUCTUATION (Body temperature still not regulated), FEELING COLD (Freezing cold), PERIPHERAL SWELLING (Arm looks like a goose egg, inflamed, and has a big bump), DIZZINESS (Dizziness), HEADACHE (Super bad headache), CHILLS (Starting at midnight,he was physically shaking because he was so cold) and PYREXIA (Fever all night) had not resolved.            No concomitant medications provided.  Patient was given water for hydration.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Rash, Vaccination site pain
Clinical narrative: she noted rashes; her arm hurt; she had headache; chills; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (her arm hurt), HEADACHE (she had headache), CHILLS (chills) and RASH (she noted rashes) 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 02-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-May-2021, the patient experienced VACCINATION SITE PAIN (her arm hurt), HEADACHE (she had headache) and CHILLS (chills). On 04-May-2021, the patient experienced RASH (she noted rashes). On 04-May-2021, VACCINATION SITE PAIN (her arm hurt), HEADACHE (she had headache) and CHILLS (chills) had resolved. At the time of the report, RASH (she noted rashes) outcome was unknown. Not Provided          Concomitant medication was not provided Treatment medication include Benadryl .  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.    This case was linked to MOD-2021-106457 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chills, Decreased appetite, Fatigue, Headache
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (miss her second dose), MALAISE (feeling sick), COVID-19 (results were positive for Covid), DECREASED APPETITE (no appetite) and MYALGIA (body aches) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, the patient experienced MALAISE (feeling sick). On 14-Apr-2021, the patient experienced COVID-19 (results were positive for Covid). On 28-Apr-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (miss her second dose). On an unknown date, the patient experienced DECREASED APPETITE (no appetite), MYALGIA (body aches), CHILLS (chills), FATIGUE (feeling very tired) and HEADACHE (headaches). The patient was treated with PARACETAMOL (TYLENOL) for Headache, Tired out, Chills, Ache and Feeling sick, at an unspecified dose and frequency. At the time of the report, PRODUCT DOSE OMISSION ISSUE (miss her second dose), MALAISE (feeling sick), COVID-19 (results were positive for Covid), DECREASED APPETITE (no appetite), MYALGIA (body aches), CHILLS (chills), FATIGUE (feeling very tired) and HEADACHE (headaches) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Apr-2021, SARS-CoV-2 test positive: positive (Positive) Positive. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medication was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Myalgia, Product dose omission issue, SARS-CoV-2 test positive
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (miss her second dose), MALAISE (feeling sick), COVID-19 (results were positive for Covid), DECREASED APPETITE (no appetite) and MYALGIA (body aches) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, the patient experienced MALAISE (feeling sick). On 14-Apr-2021, the patient experienced COVID-19 (results were positive for Covid). On 28-Apr-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (miss her second dose). On an unknown date, the patient experienced DECREASED APPETITE (no appetite), MYALGIA (body aches), CHILLS (chills), FATIGUE (feeling very tired) and HEADACHE (headaches). The patient was treated with PARACETAMOL (TYLENOL) for Headache, Tired out, Chills, Ache and Feeling sick, at an unspecified dose and frequency. At the time of the report, PRODUCT DOSE OMISSION ISSUE (miss her second dose), MALAISE (feeling sick), COVID-19 (results were positive for Covid), DECREASED APPETITE (no appetite), MYALGIA (body aches), CHILLS (chills), FATIGUE (feeling very tired) and HEADACHE (headaches) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Apr-2021, SARS-CoV-2 test positive: positive (Positive) Positive. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medication was not provided.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Tiredness/ little fatigue/ very mild; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Tiredness/ little fatigue/ very mild) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 030B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included TACROLIMUS, ALLOPURINOL and ACICLOVIR SODIUM (ACYCLOVIR ABBOTT VIAL) for an unknown indication.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-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 FATIGUE (Tiredness/ little fatigue/ very mild). At the time of the report, FATIGUE (Tiredness/ little fatigue/ very mild) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.   This case was linked to MOD-2021-106460 (Patient Link).
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Caregiver, Chills, Fatigue, Gait inability
Clinical narrative: Went to urgent care after the first dose; Walking is very difficult after the vaccine; pain; muscle pain is much worse; Chills; Joint pain which are still there; Headaches feel worse after second dose; There's always different muscles that hurt; my arm was sore for a day or two; muscle aches got worse overtime; less than 10 minutes, I had fatigue very strong; body feels like I have flu; This spontaneous case was reported by a consumer and describes the occurrence of GAIT INABILITY (Walking is very difficult after the vaccine), PAIN (pain), CAREGIVER (Went to urgent care after the first dose), MALAISE (body feels like I have flu) and MYALGIA (muscle pain is much worse) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and Lot# 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Multiple sclerosis.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced MALAISE (body feels like I have flu), FATIGUE (less than 10 minutes, I had fatigue very strong), ARTHRALGIA (my arm was sore for a day or two) and MYALGIA (muscle aches got worse overtime). On 01-Apr-2021, the patient experienced GAIT INABILITY (Walking is very difficult after the vaccine), PAIN (pain), MYALGIA (muscle pain is much worse), CHILLS (Chills), ARTHRALGIA (Joint pain which are still there), HEADACHE (Headaches feel worse after second dose) and MYALGIA (There's always different muscles that hurt). On an unknown date, the patient experienced CAREGIVER (Went to urgent care after the first dose). The patient was treated with TRAMADOL at an unspecified dose and frequency. At the time of the report, GAIT INABILITY (Walking is very difficult after the vaccine), PAIN (pain), CAREGIVER (Went to urgent care after the first dose), MALAISE (body feels like I have flu), MYALGIA (muscle pain is much worse), CHILLS (Chills), ARTHRALGIA (Joint pain which are still there), HEADACHE (Headaches feel worse after second dose), FATIGUE (less than 10 minutes, I had fatigue very strong), MYALGIA (There's always different muscles that hurt), ARTHRALGIA (my arm was sore for a day or two) and MYALGIA (muscle aches got worse overtime) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.   This case was linked to MOD-2021-106452 (Patient Link).
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Malaise, Myalgia, Pain
Clinical narrative: Went to urgent care after the first dose; Walking is very difficult after the vaccine; pain; muscle pain is much worse; Chills; Joint pain which are still there; Headaches feel worse after second dose; There's always different muscles that hurt; my arm was sore for a day or two; muscle aches got worse overtime; less than 10 minutes, I had fatigue very strong; body feels like I have flu; This spontaneous case was reported by a consumer and describes the occurrence of GAIT INABILITY (Walking is very difficult after the vaccine), PAIN (pain), CAREGIVER (Went to urgent care after the first dose), MALAISE (body feels like I have flu) and MYALGIA (muscle pain is much worse) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and Lot# 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Multiple sclerosis.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced MALAISE (body feels like I have flu), FATIGUE (less than 10 minutes, I had fatigue very strong), ARTHRALGIA (my arm was sore for a day or two) and MYALGIA (muscle aches got worse overtime). On 01-Apr-2021, the patient experienced GAIT INABILITY (Walking is very difficult after the vaccine), PAIN (pain), MYALGIA (muscle pain is much worse), CHILLS (Chills), ARTHRALGIA (Joint pain which are still there), HEADACHE (Headaches feel worse after second dose) and MYALGIA (There's always different muscles that hurt). On an unknown date, the patient experienced CAREGIVER (Went to urgent care after the first dose). The patient was treated with TRAMADOL at an unspecified dose and frequency. At the time of the report, GAIT INABILITY (Walking is very difficult after the vaccine), PAIN (pain), CAREGIVER (Went to urgent care after the first dose), MALAISE (body feels like I have flu), MYALGIA (muscle pain is much worse), CHILLS (Chills), ARTHRALGIA (Joint pain which are still there), HEADACHE (Headaches feel worse after second dose), FATIGUE (less than 10 minutes, I had fatigue very strong), MYALGIA (There's always different muscles that hurt), ARTHRALGIA (my arm was sore for a day or two) and MYALGIA (muscle aches got worse overtime) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.   This case was linked to MOD-2021-106452 (Patient Link).
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Feeling like my shingle are coming on; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Feeling like my shingle are coming on) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-2021, the patient experienced HERPES ZOSTER (Feeling like my shingle are coming on). The patient was treated with PARACETAMOL (TYLENOL) for Hypersomnia, at an unspecified dose and frequency and VALACICLOVIR HYDROCHLORIDE (VALTREX) for Shingles, at an unspecified dose and frequency. At the time of the report, HERPES ZOSTER (Feeling like my shingle are coming on) outcome was unknown. Not Provided          No concomitant medications were provided.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of urticaria (he had hives and was miserable) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 031B21A) for COVID-19 immunization. No medical history reported. On Apr 22, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On an unknown date, patient experienced urticaria (he had hives and was miserable). The patient treated with Benadryl (diphenhydramine hydrochloride), at an unspecified dose and frequency and Sarna (camphor/menthol), at an unspecified dose and frequency. At the time of the report, urticaria (he had hives and was miserable) outcome: unknown/not provided. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. No concomitant medication information provided.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Hypoaesthesia, Vaccination site erythema, Vaccination site mass, Vaccination site reaction
Clinical narrative: Immediately, his arm turned bright red and his hand went numb.; swollen and red lump at the injection site; Immediately, his arm turned bright red and his hand went numb; swollen and red lump at the injection site; swollen and red lump at the injection site; my left arm at the injection site looks as if someone cut a grape fruit in half and stuck it on the side; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Immediately, his arm turned bright red and his hand went numb.), VACCINATION SITE MASS (swollen and red lump at the injection site), HYPOAESTHESIA (Immediately, his arm turned bright red and his hand went numb), VACCINATION SITE ERYTHEMA (swollen and red lump at the injection site) and VACCINATION SITE SWELLING (swollen and red lump at the injection site) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-May-2021, the patient experienced ERYTHEMA (Immediately, his arm turned bright red and his hand went numb.), VACCINATION SITE MASS (swollen and red lump at the injection site), HYPOAESTHESIA (Immediately, his arm turned bright red and his hand went numb), VACCINATION SITE ERYTHEMA (swollen and red lump at the injection site), VACCINATION SITE SWELLING (swollen and red lump at the injection site) and VACCINATION SITE REACTION (my left arm at the injection site looks as if someone cut a grape fruit in half and stuck it on the side). At the time of the report, ERYTHEMA (Immediately, his arm turned bright red and his hand went numb.), VACCINATION SITE MASS (swollen and red lump at the injection site), HYPOAESTHESIA (Immediately, his arm turned bright red and his hand went numb), VACCINATION SITE ERYTHEMA (swollen and red lump at the injection site), VACCINATION SITE SWELLING (swollen and red lump at the injection site) and VACCINATION SITE REACTION (my left arm at the injection site looks as if someone cut a grape fruit in half and stuck it on the side) outcome was unknown. Not Provided          No concomitant medication was reported. Treatment medication was not provided.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: Immediately, his arm turned bright red and his hand went numb.; swollen and red lump at the injection site; Immediately, his arm turned bright red and his hand went numb; swollen and red lump at the injection site; swollen and red lump at the injection site; my left arm at the injection site looks as if someone cut a grape fruit in half and stuck it on the side; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Immediately, his arm turned bright red and his hand went numb.), VACCINATION SITE MASS (swollen and red lump at the injection site), HYPOAESTHESIA (Immediately, his arm turned bright red and his hand went numb), VACCINATION SITE ERYTHEMA (swollen and red lump at the injection site) and VACCINATION SITE SWELLING (swollen and red lump at the injection site) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-May-2021, the patient experienced ERYTHEMA (Immediately, his arm turned bright red and his hand went numb.), VACCINATION SITE MASS (swollen and red lump at the injection site), HYPOAESTHESIA (Immediately, his arm turned bright red and his hand went numb), VACCINATION SITE ERYTHEMA (swollen and red lump at the injection site), VACCINATION SITE SWELLING (swollen and red lump at the injection site) and VACCINATION SITE REACTION (my left arm at the injection site looks as if someone cut a grape fruit in half and stuck it on the side). At the time of the report, ERYTHEMA (Immediately, his arm turned bright red and his hand went numb.), VACCINATION SITE MASS (swollen and red lump at the injection site), HYPOAESTHESIA (Immediately, his arm turned bright red and his hand went numb), VACCINATION SITE ERYTHEMA (swollen and red lump at the injection site), VACCINATION SITE SWELLING (swollen and red lump at the injection site) and VACCINATION SITE REACTION (my left arm at the injection site looks as if someone cut a grape fruit in half and stuck it on the side) outcome was unknown. Not Provided          No concomitant medication was reported. Treatment medication was not provided.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Dyspnoea, Headache, Pyrexia
Clinical narrative: short of breath; coughing; chills; Headache; vomiting; fever; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (short of breath), COUGH (coughing), CHILLS (chills), HEADACHE (Headache) and VOMITING (vomiting) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Pneumonia. Concurrent medical conditions included Bronchitis.    On 05-Apr-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 DYSPNOEA (short of breath), COUGH (coughing), CHILLS (chills), HEADACHE (Headache), VOMITING (vomiting) and PYREXIA (fever). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, DYSPNOEA (short of breath), CHILLS (chills), HEADACHE (Headache) and VOMITING (vomiting) outcome was unknown, COUGH (coughing) had not resolved and PYREXIA (fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, X-ray: abnormal (abnormal) Diagnosed with bronchitis..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were administered. Treatment medication included tylenol two pills for the infection and one pill for cough.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting, X-ray
Clinical narrative: short of breath; coughing; chills; Headache; vomiting; fever; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (short of breath), COUGH (coughing), CHILLS (chills), HEADACHE (Headache) and VOMITING (vomiting) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Pneumonia. Concurrent medical conditions included Bronchitis.    On 05-Apr-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 DYSPNOEA (short of breath), COUGH (coughing), CHILLS (chills), HEADACHE (Headache), VOMITING (vomiting) and PYREXIA (fever). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, DYSPNOEA (short of breath), CHILLS (chills), HEADACHE (Headache) and VOMITING (vomiting) outcome was unknown, COUGH (coughing) had not resolved and PYREXIA (fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, X-ray: abnormal (abnormal) Diagnosed with bronchitis..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were administered. Treatment medication included tylenol two pills for the infection and one pill for cough.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: Intense Vertigo; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (Intense Vertigo) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Apr-2021, the patient experienced VERTIGO (Intense Vertigo). On 05-Apr-2021, VERTIGO (Intense Vertigo) had resolved. Not Provided          No treatment medications are reported.   This case was linked to MOD-2021-106485 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 06-Jun-2021: The follow up Source document received on 06-JUN-2021 contains No New Information
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Condition aggravated, Fatigue, Myalgia
Clinical narrative: weakness,could not get out of bed, he does not have energy; sleep at night is different,does not get a restful sleep; symptoms escalated over the course of 4 days; extreme fatigue,tiredness,wiped out for a good 3 to 4 hours; achiness,muscle pain; joint pain; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weakness,could not get out of bed, he does not have energy), SLEEP DISORDER (sleep at night is different,does not get a restful sleep), CONDITION AGGRAVATED (symptoms escalated over the course of 4 days), FATIGUE (extreme fatigue,tiredness,wiped out for a good 3 to 4 hours) and MYALGIA (achiness,muscle pain) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B212A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Cholesterol, Chronic pain, Diabetes and Fibromyalgia. Concomitant products included SIMVASTATIN for Cholesterol, INSULIN LISPRO (HUMALOG) and INSULIN GLARGINE (LANTUS) for Diabetes, TRAMADOL for Pain, LEVOTHYROXINE SODIUM (SYNTHROID) and LEVOTHYROXINE for Thyroid therapy, OXYCODONE, FISH OIL, CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ASTHENIA (weakness,could not get out of bed, he does not have energy), SLEEP DISORDER (sleep at night is different,does not get a restful sleep), CONDITION AGGRAVATED (symptoms escalated over the course of 4 days), FATIGUE (extreme fatigue,tiredness,wiped out for a good 3 to 4 hours), MYALGIA (achiness,muscle pain) and ARTHRALGIA (joint pain). At the time of the report, ASTHENIA (weakness,could not get out of bed, he does not have energy), SLEEP DISORDER (sleep at night is different,does not get a restful sleep), CONDITION AGGRAVATED (symptoms escalated over the course of 4 days), MYALGIA (achiness,muscle pain) and ARTHRALGIA (joint pain) outcome was unknown and FATIGUE (extreme fatigue,tiredness,wiped out for a good 3 to 4 hours) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications includes Oxycodone short acting along with above mentioned medications. Treatment medication reported includes Oxycodone ER, Oxycodone short acting, and Tramadol.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Sleep disorder
Clinical narrative: weakness,could not get out of bed, he does not have energy; sleep at night is different,does not get a restful sleep; symptoms escalated over the course of 4 days; extreme fatigue,tiredness,wiped out for a good 3 to 4 hours; achiness,muscle pain; joint pain; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weakness,could not get out of bed, he does not have energy), SLEEP DISORDER (sleep at night is different,does not get a restful sleep), CONDITION AGGRAVATED (symptoms escalated over the course of 4 days), FATIGUE (extreme fatigue,tiredness,wiped out for a good 3 to 4 hours) and MYALGIA (achiness,muscle pain) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B212A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Cholesterol, Chronic pain, Diabetes and Fibromyalgia. Concomitant products included SIMVASTATIN for Cholesterol, INSULIN LISPRO (HUMALOG) and INSULIN GLARGINE (LANTUS) for Diabetes, TRAMADOL for Pain, LEVOTHYROXINE SODIUM (SYNTHROID) and LEVOTHYROXINE for Thyroid therapy, OXYCODONE, FISH OIL, CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ASTHENIA (weakness,could not get out of bed, he does not have energy), SLEEP DISORDER (sleep at night is different,does not get a restful sleep), CONDITION AGGRAVATED (symptoms escalated over the course of 4 days), FATIGUE (extreme fatigue,tiredness,wiped out for a good 3 to 4 hours), MYALGIA (achiness,muscle pain) and ARTHRALGIA (joint pain). At the time of the report, ASTHENIA (weakness,could not get out of bed, he does not have energy), SLEEP DISORDER (sleep at night is different,does not get a restful sleep), CONDITION AGGRAVATED (symptoms escalated over the course of 4 days), MYALGIA (achiness,muscle pain) and ARTHRALGIA (joint pain) outcome was unknown and FATIGUE (extreme fatigue,tiredness,wiped out for a good 3 to 4 hours) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications includes Oxycodone short acting along with above mentioned medications. Treatment medication reported includes Oxycodone ER, Oxycodone short acting, and Tramadol.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives on left thigh; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives on left thigh) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-May-2021, the patient experienced URTICARIA (Hives on left thigh). At the time of the report, URTICARIA (Hives on left thigh) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Teatment given included Benadryl.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain in extremity
Clinical narrative: pain on right arm; headache; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain on right arm), HEADACHE (headache) and FATIGUE (fatigue) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included mobic                                                          arthritis for Arthritis, duloxetine                                                     depression for Depression, protonix                                                       gerd for GERD.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, the patient experienced PAIN IN EXTREMITY (pain on right arm), HEADACHE (headache) and FATIGUE (fatigue). At the time of the report, PAIN IN EXTREMITY (pain on right arm), HEADACHE (headache) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-106488 (Patient Link).
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: Vertigo comes in waves; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (Vertigo comes in waves) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-May-2021, the patient experienced VERTIGO (Vertigo comes in waves). At the time of the report, VERTIGO (Vertigo comes in waves) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.     This case was linked to MOD-2021-106475 (Patient Link).
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20A and 012L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Mar-2021, the patient experienced DIARRHOEA (Diarrhea). At the time of the report, DIARRHOEA (Diarrhea) had not resolved. Not Provided          This case was linked to MOD-2021-079056 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: Follow up received on 05-MAY-2021 event outcome changed
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Product dose omission issue, Pyrexia
Clinical narrative: More than 36 days have passed since first dose; mild body aches; mild fever; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (More than 36 days have passed since first dose), MYALGIA (mild body aches) and PYREXIA (mild fever) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 28-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 PRODUCT DOSE OMISSION ISSUE (More than 36 days have passed since first dose), MYALGIA (mild body aches) and PYREXIA (mild fever). At the time of the report, PRODUCT DOSE OMISSION ISSUE (More than 36 days have passed since first dose), MYALGIA (mild body aches) and PYREXIA (mild fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details were reported. No Treatment Medications were reported.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Mass, Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: arm  swelling; sore arm; red lump on arm; arm itchy; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (arm  swelling), PAIN IN EXTREMITY (sore arm), MASS (red lump on arm) and PRURITUS (arm itchy) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014C21A and 018B21A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included MELOXICAM (MOBIC) for Arthritis, DULOXETINE for Depression, OMEPRAZOLE (PROTONIX [OMEPRAZOLE]) for GERD.   On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-May-2021, the patient experienced PERIPHERAL SWELLING (arm  swelling), PAIN IN EXTREMITY (sore arm) and MASS (red lump on arm). 04-May-2021, the patient experienced PRURITUS (arm itchy). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, PERIPHERAL SWELLING (arm  swelling), PAIN IN EXTREMITY (sore arm), MASS (red lump on arm) and PRURITUS (arm itchy) outcome was unknown.            This case was linked to MOD-2021-106480 (Patient Link).
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash; Rash; This spontaneous case was reported by a nurse and describes the occurrence of the first episode of RASH (Rash) and the second episode of RASH (Rash) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     No medical history reported.  Concomitant products included APIXABAN (ELIQUIS), EZETIMIBE (ZETIA), FUROSEMIDE (LASIX [FUROSEMIDE]), METOPROLOL, AMLODIPINE, OLMESARTAN, ALPRAZOLAM (XANAX), DIGOXIN, MULTIVITAMIN [VITAMINS NOS], FISH OIL, VITAMIN E [VITAMIN E NOS], VITAMIN C [ASCORBIC ACID], VITAMIN D3, DENOSUMAB (PROLIA) and PROBIOTICS NOS for an unknown indication.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced the first episode of RASH (Rash). On 20-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced the second episode of RASH (Rash). At the time of the report, last episode of RASH (Rash) had not resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication include osteo bio flex three to four times weekly.  Treatment for the events include anti-itch gold bond cream.  The patient experienced Rash(red and itchy in nature ) from the shoulder to the elbow, which got spread to all over the body.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Feeling abnormal, Illness, Loss of personal independence in daily activities, Malaise
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (the pain appear in the arm), FEELING ABNORMAL (feels like a piece of my arm was removed), PAIN (never felt this kind of pain,it's like it's in the bone), MALAISE (feeling sick) and FEELING ABNORMAL (Make my life horrible) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. 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 04-May-2021, the patient experienced PAIN (never felt this kind of pain,it's like it's in the bone). On an unknown date, the patient experienced PAIN IN EXTREMITY (the pain appear in the arm), FEELING ABNORMAL (feels like a piece of my arm was removed), MALAISE (feeling sick), FEELING ABNORMAL (Make my life horrible), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (can't take a shower), PAIN (terrible pain), COVID-19 (Got COVID) and ILLNESS (little bit sick for 5 days). At the time of the report, PAIN IN EXTREMITY (the pain appear in the arm), FEELING ABNORMAL (feels like a piece of my arm was removed), PAIN (never felt this kind of pain,it's like it's in the bone), MALAISE (feeling sick), FEELING ABNORMAL (Make my life horrible), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (can't take a shower), PAIN (terrible pain), COVID-19 (Got COVID) and ILLNESS (little bit sick for 5 days) outcome was unknown. Not Provided. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: Positive. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant and treatment medications were not provided by reporter.