chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: warm; upper arm is still red; itchy; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE WARMTH (warm), VACCINATION SITE ERYTHEMA (upper arm is still red) and VACCINATION SITE PRURITUS (itchy) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (warm), VACCINATION SITE ERYTHEMA (upper arm is still red) and VACCINATION SITE PRURITUS (itchy). At the time of the report, VACCINATION SITE WARMTH (warm), VACCINATION SITE ERYTHEMA (upper arm is still red) and VACCINATION SITE PRURITUS (itchy) had not resolved.            No concomitant medications were reported. no treatment details were reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Facility had been administering an expired lot number to multiple patients; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Facility had been administering an expired lot number to multiple patients) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) 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 EXPIRED PRODUCT ADMINISTERED (Facility had been administering an expired lot number to multiple patients). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Facility had been administering an expired lot number to multiple patients) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No concomitant medications was reported.  No treatment drug details was reported.  Date the vial was initially stored in refrigerator on 15-Oct-2021. Other administration dates prior to 03-Dec-2021 and also on 03-Dec-2021.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of personal independence in daily activities, Photosensitivity reaction, Pruritus, Rash, Type IV hypersensitivity reaction
Clinical narrative: Can't swim; No longer sit in the sun; Late allergic reaction to the Moderna Covid 19 vaccine; After the 2nd dose started itching very badly on upper left arm and shoulder/ by summer itching started happen in the evening and also moved to the right arm; A very bad rash; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Can't swim), PHOTOSENSITIVITY REACTION (No longer sit in the sun), TYPE IV HYPERSENSITIVITY REACTION (Late allergic reaction to the Moderna Covid 19 vaccine), PRURITUS (After the 2nd dose started itching very badly on upper left arm and shoulder/ by summer itching started happen in the evening and also moved to the right arm) and RASH (A very bad rash) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029K20A and 039K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-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 LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Can't swim), PHOTOSENSITIVITY REACTION (No longer sit in the sun) and TYPE IV HYPERSENSITIVITY REACTION (Late allergic reaction to the Moderna Covid 19 vaccine). an unknown date, the patient experienced PRURITUS (After the 2nd dose started itching very badly on upper left arm and shoulder/ by summer itching started happen in the evening and also moved to the right arm) and RASH (A very bad rash). At the time of the report, LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Can't swim), PHOTOSENSITIVITY REACTION (No longer sit in the sun), TYPE IV HYPERSENSITIVITY REACTION (Late allergic reaction to the Moderna Covid 19 vaccine) and RASH (A very bad rash) outcome was unknown and PRURITUS (After the 2nd dose started itching very badly on upper left arm and shoulder/ by summer itching started happen in the evening and also moved to the right arm) had not resolved.            No concomitant medications were reported.  Treatment details included steroid ointment to relieve itching topically. Patient stated that she visited several dermatologist. The first one diagnoses was a late allergic reaction to the Moderna COVID-19 vaccine, the second doctor disapproved the diagnosis of previous doctor that stated it was related to Moderna. Dermatologist recommended stay out of the sun.   This case was linked to MOD-2021-404428 (Patient Link).
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: full dose (0.5 ml) given for booster dose; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL OVERDOSE (full dose (0.5 ml) given for booster dose) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: J & J vaccine (J & J vaccine). Past adverse reactions to the above products included No adverse event with J & J vaccine.    On 03-Dec-2021 at 11:35 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Dec-2021, the patient experienced ACCIDENTAL OVERDOSE (full dose (0.5 ml) given for booster dose). On 03-Dec-2021, ACCIDENTAL OVERDOSE (full dose (0.5 ml) given for booster dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided.  Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Frustration tolerance decreased, Illness, Nausea, Vomiting
Clinical narrative: Patient was very frustrated; felt sick; nausea; little vomiting; This spontaneous case was reported by a consumer and describes the occurrence of FRUSTRATION TOLERANCE DECREASED (Patient was very frustrated), ILLNESS (felt sick), NAUSEA (nausea) and VOMITING (little vomiting) 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-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Dec-2021, the patient experienced FRUSTRATION TOLERANCE DECREASED (Patient was very frustrated), ILLNESS (felt sick), NAUSEA (nausea) and VOMITING (little vomiting). At the time of the report, FRUSTRATION TOLERANCE DECREASED (Patient was very frustrated), ILLNESS (felt sick), NAUSEA (nausea) and VOMITING (little vomiting) outcome was unknown.            The patient started to feel sick  on 04-Dec-2021 (today )at 9:30.The patient had nausea and a little vomiting. The patient was very frustrated and was not interested in answering anything.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Myalgia, Pyrexia
Clinical narrative: chills; low grade fever; achiness; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), PYREXIA (low grade fever) and MYALGIA (achiness) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Nov-2021, the patient experienced CHILLS (chills), PYREXIA (low grade fever) and MYALGIA (achiness). At the time of the report, CHILLS (chills), PYREXIA (low grade fever) and MYALGIA (achiness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications was reported. No treatment drug details was reported.  The events lasted for 24 hours.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: Is it common to run a fever of 100 after the second vaccine shot; This spontaneous case was reported by an other health care professional and describes the occurrence of PYREXIA (Is it common to run a fever of 100 after the second vaccine shot) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Is it common to run a fever of 100 after the second vaccine shot). At the time of the report, PYREXIA (Is it common to run a fever of 100 after the second vaccine shot) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100 (High) fever of 100.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication list was not provided. Treatment information was not provided.   Reporter did not allow further contact
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: She said that with the first 2 shots she got "fever and chills, not a real deal; She said that with the first 2 shots she got "fever and chills, not a real deal; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (She said that with the first 2 shots she got "fever and chills, not a real deal) and CHILLS (She said that with the first 2 shots she got "fever and chills, not a real deal) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history  was reported.  Concomitant products included ESTRADIOL BENZOATE (ESTRADIOL [ESTRADIOL BENZOATE]) for an unknown indication.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In September 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 PYREXIA (She said that with the first 2 shots she got "fever and chills, not a real deal) and CHILLS (She said that with the first 2 shots she got "fever and chills, not a real deal). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency and ALUMINIUM HYDROXIDE GEL, DRIED, MAGNESIUM CARBONATE (PEPCID [ALUMINIUM HYDROXIDE GEL, DRIED;MAGNESIUM CARBONATE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, PYREXIA (She said that with the first 2 shots she got "fever and chills, not a real deal) and CHILLS (She said that with the first 2 shots she got "fever and chills, not a real deal) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       some supplements as regular medication was reported. 7 months later patient received the 2nd dose and the booster shot  on the 03Dec2021.   This case was linked to MOD-2021-404471, MOD-2021-404472 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: vial punctured more than 20 times; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vial punctured more than 20 times) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (vial punctured more than 20 times). At the time of the report, EXPIRED PRODUCT ADMINISTERED (vial punctured more than 20 times) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication were reported. No treatment medication were reported.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Headache, Neck pain, Toothache
Clinical narrative: head, neck, teeth aches; head, neck, teeth aches; dizziness; head, neck, teeth aches; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (head, neck, teeth aches), TOOTHACHE (head, neck, teeth aches), DIZZINESS (dizziness) and HEADACHE (head, neck, teeth aches) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Heart murmur.    On 02-Dec-2021 at 12:00 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NECK PAIN (head, neck, teeth aches), TOOTHACHE (head, neck, teeth aches), DIZZINESS (dizziness) and HEADACHE (head, neck, teeth aches). At the time of the report, NECK PAIN (head, neck, teeth aches), TOOTHACHE (head, neck, teeth aches), DIZZINESS (dizziness) and HEADACHE (head, neck, teeth aches) outcome was unknown.            No concomitant medication was reported.  No treatment medication use was reported   This case was linked to MOD-2021-404357 (Patient Link).   Reporter did not allow further contact
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain
Clinical narrative: Achy after second vaccination; Headache after second vaccination; Chill after second vaccination; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Achy after second vaccination), HEADACHE (Headache after second vaccination) and CHILLS (Chill after second vaccination) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN (Achy after second vaccination), HEADACHE (Headache after second vaccination) and CHILLS (Chill after second vaccination). At the time of the report, PAIN (Achy after second vaccination), HEADACHE (Headache after second vaccination) and CHILLS (Chill after second vaccination) outcome was unknown.            No concomitant medications were reported.  Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: side effect from the Modena booster; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (side effect from the Modena booster) 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 November 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In November 2021, the patient experienced VACCINATION COMPLICATION (side effect from the Modena booster). At the time of the report, VACCINATION COMPLICATION (side effect from the Modena booster) outcome was unknown.            No concomitant medications were reported  No treatment information was provided
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: "had the shakes at night"; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR ("had the shakes at night") in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Heart murmur.    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 TREMOR ("had the shakes at night"). At the time of the report, TREMOR ("had the shakes at night") outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. Treatment medication was not provided by the reporter.   This case was linked to MOD-2021-404347 (Patient Link).   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: gave a higher dose than intended; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL OVERDOSE (gave a higher dose than intended) 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 03-Dec-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Dec-2021, the patient experienced ACCIDENTAL OVERDOSE (gave a higher dose than intended). On 03-Dec-2021, ACCIDENTAL OVERDOSE (gave a higher dose than intended) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported by the reporter.  No treatment medication was reported by the reporter.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Constipation, Dizziness, Headache, Malaise
Clinical narrative: feeling very crummy; dizzy; weak, very miserable; bit constipated; broken up aches and pains; very bad headache; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (feeling very crummy), DIZZINESS (dizzy), ASTHENIA (weak, very miserable), CONSTIPATION (bit constipated) and PAIN (broken up aches and pains) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030H21B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: Pfizer double vaccine from 01-Apr-2021 to 26-Apr-2021. Past adverse reactions to the above products included No adverse event with Pfizer double vaccine.    On 02-Dec-2021 at 1:00 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (feeling very crummy), DIZZINESS (dizzy), ASTHENIA (weak, very miserable), CONSTIPATION (bit constipated), PAIN (broken up aches and pains) and HEADACHE (very bad headache). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) on 03-Dec-2021 at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) on 03-Dec-2021 at an unspecified dose and frequency. At the time of the report, MALAISE (feeling very crummy), DIZZINESS (dizzy), ASTHENIA (weak, very miserable), CONSTIPATION (bit constipated) and PAIN (broken up aches and pains) outcome was unknown and HEADACHE (very bad headache) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. The patient reported a very rough night. The headache had subsided a bit, but he was up most of the night.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: feeling very crummy; dizzy; weak, very miserable; bit constipated; broken up aches and pains; very bad headache; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (feeling very crummy), DIZZINESS (dizzy), ASTHENIA (weak, very miserable), CONSTIPATION (bit constipated) and PAIN (broken up aches and pains) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030H21B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: Pfizer double vaccine from 01-Apr-2021 to 26-Apr-2021. Past adverse reactions to the above products included No adverse event with Pfizer double vaccine.    On 02-Dec-2021 at 1:00 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (feeling very crummy), DIZZINESS (dizzy), ASTHENIA (weak, very miserable), CONSTIPATION (bit constipated), PAIN (broken up aches and pains) and HEADACHE (very bad headache). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) on 03-Dec-2021 at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) on 03-Dec-2021 at an unspecified dose and frequency. At the time of the report, MALAISE (feeling very crummy), DIZZINESS (dizzy), ASTHENIA (weak, very miserable), CONSTIPATION (bit constipated) and PAIN (broken up aches and pains) outcome was unknown and HEADACHE (very bad headache) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. The patient reported a very rough night. The headache had subsided a bit, but he was up most of the night.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Dry eye, Eye pain
Clinical narrative: dryness in both eyes; pain in right eye; This spontaneous case was reported by a consumer and describes the occurrence of DRY EYE (dryness in both eyes) and EYE PAIN (pain in right eye) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018F21A, 032L20A and 026L20A) for COVID-19 vaccination.     Concurrent medical conditions included Uveitis and Blind right eye. Concomitant products included PREDNISONE, MOXIFLOXACIN HYDROCHLORIDE (VIGAMOX), METOPROLOL, ATORVASTATIN, AMLODIPINE and OMEPRAZOLE for an unknown indication.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Nov-2021, the patient experienced DRY EYE (dryness in both eyes) and EYE PAIN (pain in right eye). The patient was treated with PREDNISOLONE ongoing since an unknown date at an unspecified dose and frequency and CARMELLOSE SODIUM (REFRESH [CARMELLOSE SODIUM]) ongoing since an unknown date for Adverse event, at an unspecified dose and frequency. At the time of the report, DRY EYE (dryness in both eyes) had not resolved and EYE PAIN (pain in right eye) was resolving.            Pain in the right eye had reduced down to around 30%.
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Myalgia
Clinical narrative: felt bad/not feeling that good; aching; head is hurting a little bit; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt bad/not feeling that good), MYALGIA (aching) and HEADACHE (head is hurting a little bit) 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) at an unspecified dose. On an unknown date, the patient experienced FEELING ABNORMAL (felt bad/not feeling that good), MYALGIA (aching) and HEADACHE (head is hurting a little bit). At the time of the report, FEELING ABNORMAL (felt bad/not feeling that good) was resolving and MYALGIA (aching) and HEADACHE (head is hurting a little bit) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Sinus headache
Clinical narrative: Sinus kind of headache/ headache is increasing; Body ache/ body ache is increasing; This spontaneous case was reported by a patient and describes the occurrence of SINUS HEADACHE (Sinus kind of headache/ headache is increasing) and MYALGIA (Body ache/ body ache is increasing) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 077C21B, 026L20A and 029L20A) for COVID-19 vaccination.     Concomitant products included METOPROLOL TARTRATE, ACETYLSALICYLIC ACID (BABY ASPIRIN), ROSUVASTATIN and PANTOPRAZOLE for an unknown indication.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Dec-2021, the patient experienced SINUS HEADACHE (Sinus kind of headache/ headache is increasing) and MYALGIA (Body ache/ body ache is increasing). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] for Headache sinus and Myalgia, at a dose of 325 mg. At the time of the report, SINUS HEADACHE (Sinus kind of headache/ headache is increasing) and MYALGIA (Body ache/ body ache is increasing) had not resolved.            No medical history was provided by the reporter.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Hyperhidrosis, Hypoaesthesia, Nausea
Clinical narrative: having some numbness in the limbs/having some numbness in the face/numbness and tingles on my left arm and foot/last night in the middle of the night it started to travel across my chest, upper back to my right arm and hand; all sweat up; having some tingling in the limbs/having some tingling in the face/numbness and tingles on my left arm and foot; felt faint; sore arm; headache; nausea; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (having some numbness in the limbs/having some numbness in the face/numbness and tingles on my left arm and foot/last night in the middle of the night it started to travel across my chest, upper back to my right arm and hand), HYPERHIDROSIS (all sweat up), PARAESTHESIA (having some tingling in the limbs/having some tingling in the face/numbness and tingles on my left arm and foot), DIZZINESS (felt faint) and VACCINATION SITE PAIN (sore arm) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 30-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In November 2021, the patient experienced HYPOAESTHESIA (having some numbness in the limbs/having some numbness in the face/numbness and tingles on my left arm and foot/last night in the middle of the night it started to travel across my chest, upper back to my right arm and hand), HYPERHIDROSIS (all sweat up), PARAESTHESIA (having some tingling in the limbs/having some tingling in the face/numbness and tingles on my left arm and foot), DIZZINESS (felt faint), VACCINATION SITE PAIN (sore arm), HEADACHE (headache) and NAUSEA (nausea). At the time of the report, HYPOAESTHESIA (having some numbness in the limbs/having some numbness in the face/numbness and tingles on my left arm and foot/last night in the middle of the night it started to travel across my chest, upper back to my right arm and hand), HYPERHIDROSIS (all sweat up), PARAESTHESIA (having some tingling in the limbs/having some tingling in the face/numbness and tingles on my left arm and foot), HEADACHE (headache) and NAUSEA (nausea) outcome was unknown and DIZZINESS (felt faint) and VACCINATION SITE PAIN (sore arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication reported. treatment medication includes antihistamines   Most recent FOLLOW-UP information incorporated above includes: On 04-Dec-2021: follow-up received on 04-DEC-2021 contains significant information which includes patient demographic details updated, new events  added, treatment information added
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Vaccination site pain
Clinical narrative: having some numbness in the limbs/having some numbness in the face/numbness and tingles on my left arm and foot/last night in the middle of the night it started to travel across my chest, upper back to my right arm and hand; all sweat up; having some tingling in the limbs/having some tingling in the face/numbness and tingles on my left arm and foot; felt faint; sore arm; headache; nausea; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (having some numbness in the limbs/having some numbness in the face/numbness and tingles on my left arm and foot/last night in the middle of the night it started to travel across my chest, upper back to my right arm and hand), HYPERHIDROSIS (all sweat up), PARAESTHESIA (having some tingling in the limbs/having some tingling in the face/numbness and tingles on my left arm and foot), DIZZINESS (felt faint) and VACCINATION SITE PAIN (sore arm) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 30-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In November 2021, the patient experienced HYPOAESTHESIA (having some numbness in the limbs/having some numbness in the face/numbness and tingles on my left arm and foot/last night in the middle of the night it started to travel across my chest, upper back to my right arm and hand), HYPERHIDROSIS (all sweat up), PARAESTHESIA (having some tingling in the limbs/having some tingling in the face/numbness and tingles on my left arm and foot), DIZZINESS (felt faint), VACCINATION SITE PAIN (sore arm), HEADACHE (headache) and NAUSEA (nausea). At the time of the report, HYPOAESTHESIA (having some numbness in the limbs/having some numbness in the face/numbness and tingles on my left arm and foot/last night in the middle of the night it started to travel across my chest, upper back to my right arm and hand), HYPERHIDROSIS (all sweat up), PARAESTHESIA (having some tingling in the limbs/having some tingling in the face/numbness and tingles on my left arm and foot), HEADACHE (headache) and NAUSEA (nausea) outcome was unknown and DIZZINESS (felt faint) and VACCINATION SITE PAIN (sore arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication reported. treatment medication includes antihistamines   Most recent FOLLOW-UP information incorporated above includes: On 04-Dec-2021: follow-up received on 04-DEC-2021 contains significant information which includes patient demographic details updated, new events  added, treatment information added
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication, Vaccination site rash
Clinical narrative: Moderna arm; rash at the injection stie/covid rash; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Moderna arm) and VACCINATION SITE RASH (rash at the injection site/Covid rash) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     No medical history provided by reporter.  Concomitant products included VALACYCLOVIR [VALACICLOVIR] and SPIRONOLACTONE for an unknown indication.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced VACCINATION COMPLICATION (Moderna arm) and VACCINATION SITE RASH (rash at the injection site/Covid rash). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Adverse reaction, at an unspecified dose and frequency. At the time of the report, VACCINATION COMPLICATION (Moderna arm) and VACCINATION SITE RASH (rash at the injection stie/covid rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-404415, MOD-2021-404423, MOD-2021-404534 (Patient Link).
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Hypertension, Urticaria
Clinical narrative: Patient has high blood pressure because of the hives; Patient broke up in bad hives; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Patient broke up in bad hives) and HYPERTENSION (Patient has high blood pressure because of the hives) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 071F21A) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE for an unknown indication.    On 06-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Nov-2021, the patient experienced URTICARIA (Patient broke up in bad hives). On an unknown date, the patient experienced HYPERTENSION (Patient has high blood pressure because of the hives). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at an unspecified dose and frequency; PREDNISONE at an unspecified dose and frequency and PEPSIN at an unspecified dose and frequency. At the time of the report, URTICARIA (Patient broke up in bad hives) and HYPERTENSION (Patient has high blood pressure because of the hives) outcome was unknown.            concomitant medication included levothyroxine used for thyroids
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Sick; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sick) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023C21A. and 042E21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high.   On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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. In May 2021, the patient experienced ILLNESS (Sick). In May 2021, ILLNESS (Sick) had resolved.            Concomitant information was not provided.  It was reported that patient was sick for 2 days and took almost one week to be back to normal.  Treatment information was not provided.   This case was linked to MOD-2021-404385 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: adverse effect; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (adverse effect) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (adverse effect). At the time of the report, VACCINATION COMPLICATION (adverse effect) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided.  Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Muscle spasms
Clinical narrative: bad cramps; This spontaneous case was reported by an other health care professional and describes the occurrence of MUSCLE SPASMS (bad cramps) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MUSCLE SPASMS (bad cramps). At the time of the report, MUSCLE SPASMS (bad cramps) 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 concomitant medications reported by reporter No treatment medications provided by the reporter.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Nasopharyngitis, Pain in extremity
Clinical narrative: I felt a little off, like I had a small, slight cold; My arm was sore; Slight cold; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (I felt a little off, like I had a small, slight cold), PAIN IN EXTREMITY (My arm was sore) and NASOPHARYNGITIS (Slight cold) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021B21A and 013A21A) for COVID-19 vaccination.     The patient's past medical history included Heart failure, Tachycardia, Bradycardia, Atrial fibrillation, Atrial flutter, Dressler's syndrome ((Pericarditis)), COVID-19 (Patient tested positive), Hip replacement (Left hip done 7 months ago.), Thoracotomy (Took blood out of patient lungs. Patient had a thoracotomy to correct problem.) and Surgery (About 8 or 9 yrs ago patient had Mini-Maze heart surgery.). Concurrent medical conditions included COPD. Concomitant products included BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT) for an unknown indication.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Apr-2021, the patient experienced MALAISE (I felt a little off, like I had a small, slight cold), PAIN IN EXTREMITY (My arm was sore) and NASOPHARYNGITIS (Slight cold). The patient was treated with ALBUTEROL [SALBUTAMOL] ongoing since an unknown date for Adverse event, at an unspecified dose and frequency and AMOXICILLIN for Adverse event, at a dose of 875 mg twice a day. At the time of the report, MALAISE (I felt a little off, like I had a small, slight cold), PAIN IN EXTREMITY (My arm was sore) and NASOPHARYNGITIS (Slight cold) outcome was unknown.            This case was linked to MOD-2021-404300, MOD-2021-404411 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: fever post vaccine administration; This spontaneous case was reported by a physician and describes the occurrence of PYREXIA (fever post vaccine administration) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (fever post vaccine administration). At the time of the report, PYREXIA (fever post vaccine administration) 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.   Concomitant medications was not provided by the reporter. Treatment information was not provided. Patient asked antipyretic  can be take for fever post vaccine administration?
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Sensitive skin, Urticaria
Clinical narrative: rashes all over my body/rash comes and goes; hives all over my torso/hives in both arms/hives in stomach/hives in back/if I scratch, it will turn into a welt; sensitive skin; itchy; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives all over my torso/hives in both arms/hives in stomach/hives in back/if I scratch, it will turn into a welt), SENSITIVE SKIN (sensitive skin), PRURITUS (itchy) and RASH (rashes all over my body/rash comes and goes) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939903, 047A21A. and 012A21A) for COVID-19 vaccination.     Concomitant products included VALACYCLOVIR [VALACICLOVIR] and SPIRONOLACTONE for an unknown indication.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced URTICARIA (hives all over my torso/hives in both arms/hives in stomach/hives in back/if I scratch, it will turn into a welt), SENSITIVE SKIN (sensitive skin) and PRURITUS (itchy). On an unknown date, the patient experienced RASH (rashes all over my body/rash comes and goes). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at a dose of several weeks everyday. In 2021, PRURITUS (itchy) had resolved. At the time of the report, URTICARIA (hives all over my torso/hives in both arms/hives in stomach/hives in back/if I scratch, it will turn into a welt) and SENSITIVE SKIN (sensitive skin) had not resolved and RASH (rashes all over my body/rash comes and goes) outcome was unknown.            This case was linked to MOD-2021-404415, MOD-2021-404394, MOD-2021-404415, MOD-2021-404534, MOD-2021-404423 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal, Influenza like illness
Clinical narrative: pretty much like the worst flu I've ever had; really worried/really frightening/really unhappy; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (pretty much like the worst flu I've ever had) and FEELING ABNORMAL (really worried/really frightening/really unhappy) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (pretty much like the worst flu I've ever had) and FEELING ABNORMAL (really worried/really frightening/really unhappy). At the time of the report, INFLUENZA LIKE ILLNESS (pretty much like the worst flu I've ever had) and FEELING ABNORMAL (really worried/really frightening/really unhappy) outcome was unknown.            NO Concomitant drug reported. NO Treatment drug reported.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Pyrexia
Clinical narrative: body aches; chills; fever; headache; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (body aches), CHILLS (chills), PYREXIA (fever) and HEADACHE (headache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (body aches), CHILLS (chills), PYREXIA (fever) and HEADACHE (headache). At the time of the report, MYALGIA (body aches), CHILLS (chills), PYREXIA (fever) and HEADACHE (headache) outcome was unknown.            No treatment and concomitant medications were provided. The patient was having body aches, chills, fever and headache.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate, Tremor
Clinical narrative: Patient started to shake all body; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Patient started to shake all body) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045JUT) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Dec-2021, the patient experienced TREMOR (Patient started to shake all body). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) on 04-Dec-2021 for Adverse event, at an unspecified dose and frequency. At the time of the report, TREMOR (Patient started to shake all body) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Dec-2021, Heart rate: 100 (High) 100 heartbeats per minute.         Concomitant medications were not provided.  Patient took Tylenol 10 minutes after booster dose.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arms; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arms) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027H21B, 013A21A and 007B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Dec-2021, received third 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 (Sore arms). At the time of the report, PAIN IN EXTREMITY (Sore arms) outcome was unknown.            No concomitant medications were reported.  Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: currently having a hard time getting around; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (currently having a hard time getting around) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (currently having a hard time getting around). At the time of the report, VACCINATION COMPLICATION (currently having a hard time getting around) outcome was unknown.            No concomitant medications reported by reporter. No treatment medications provided by the reporter.   Reporter did not allow further contact