chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Bedridden, Chills, Feeling cold, Gait inability, Myalgia
Clinical narrative: heat turned up to maximum in his room and he still felt cold; felt incapacitated in bed whole day; in bed whole day; muscle aches that never seemed to go away/muscle pain; fever; bad chills; This spontaneous case was reported by a pharmacist and describes the occurrence of FEELING COLD (heat turned up to maximum in his room and he still felt cold), GAIT INABILITY (felt incapacitated in bed whole day), BEDRIDDEN (in bed whole day), MYALGIA (muscle aches that never seemed to go away/muscle pain) and PYREXIA (fever) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0131A21A and 030M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension (Mild) and Allergy. Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Allergy, AMLODIPINE for Hypertension.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Mar-2021, the patient experienced GAIT INABILITY (felt incapacitated in bed whole day), BEDRIDDEN (in bed whole day), MYALGIA (muscle aches that never seemed to go away/muscle pain), PYREXIA (fever) and CHILLS (bad chills). On an unknown date, the patient experienced FEELING COLD (heat turned up to maximum in his room and he still felt cold). On 11-Mar-2021, GAIT INABILITY (felt incapacitated in bed whole day), PYREXIA (fever) and CHILLS (bad chills) had resolved. On 12-Mar-2021, BEDRIDDEN (in bed whole day) had resolved. At the time of the report, FEELING COLD (heat turned up to maximum in his room and he still felt cold) outcome was unknown and MYALGIA (muscle aches that never seemed to go away/muscle pain) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medications were provided.  Patient had annoying muscle aches in the morning, which would dissipate throughout the day.   This case was linked to MOD-2021-405274 (Patient Link).
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: heat turned up to maximum in his room and he still felt cold; felt incapacitated in bed whole day; in bed whole day; muscle aches that never seemed to go away/muscle pain; fever; bad chills; This spontaneous case was reported by a pharmacist and describes the occurrence of FEELING COLD (heat turned up to maximum in his room and he still felt cold), GAIT INABILITY (felt incapacitated in bed whole day), BEDRIDDEN (in bed whole day), MYALGIA (muscle aches that never seemed to go away/muscle pain) and PYREXIA (fever) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0131A21A and 030M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension (Mild) and Allergy. Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Allergy, AMLODIPINE for Hypertension.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Mar-2021, the patient experienced GAIT INABILITY (felt incapacitated in bed whole day), BEDRIDDEN (in bed whole day), MYALGIA (muscle aches that never seemed to go away/muscle pain), PYREXIA (fever) and CHILLS (bad chills). On an unknown date, the patient experienced FEELING COLD (heat turned up to maximum in his room and he still felt cold). On 11-Mar-2021, GAIT INABILITY (felt incapacitated in bed whole day), PYREXIA (fever) and CHILLS (bad chills) had resolved. On 12-Mar-2021, BEDRIDDEN (in bed whole day) had resolved. At the time of the report, FEELING COLD (heat turned up to maximum in his room and he still felt cold) outcome was unknown and MYALGIA (muscle aches that never seemed to go away/muscle pain) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medications were provided.  Patient had annoying muscle aches in the morning, which would dissipate throughout the day.   This case was linked to MOD-2021-405274 (Patient Link).
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm after initial series; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm after initial series) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     Concurrent medical conditions included Lung disorder NOS (Lungs problem). Concomitant products included VITAMIN D NOS and VITAMIN B NOS for an unknown indication.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced PAIN IN EXTREMITY (sore arm after initial series). In 2021, PAIN IN EXTREMITY (sore arm after initial series) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient has a tracheotomy on their neck Concomitant medications includes medication for sugar, medication for high blood pressure, four different inhalers for lung problems. Treatment medication was not provided by the reporter.   This case was linked to MOD-2021-405078, MOD-2021-405079 (Patient Link).
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Vaccination site rash
Clinical narrative: Delayed rash on left arm; Rash starts at the injection site and is crossed-banded; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Delayed rash on left arm) and VACCINATION SITE RASH (Rash starts at the injection site and is crossed-banded) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939903, 011A21A and 016M20A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy and Drug allergy (Allergic to Lisinopril.).   On 21-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Mar-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 05-Dec-2021, the patient experienced RASH (Delayed rash on left arm) and VACCINATION SITE RASH (Rash starts at the injection site and is crossed-banded). At the time of the report, RASH (Delayed rash on left arm) and VACCINATION SITE RASH (Rash starts at the injection site and is crossed-banded) outcome was unknown.            No concomitant product use was provided by the reporter. No treatment medication was provided.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: knee stopped hurting again and hip stopped hurting and she feels like she is 20 years younger; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (knee stopped hurting again and hip stopped hurting and she feels like she is 20 years younger) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031H21A, 038B21A and 031A21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure abnormal.   On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (knee stopped hurting again and hip stopped hurting and she feels like she is 20 years younger). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (knee stopped hurting again and hip stopped hurting and she feels like she is 20 years younger) outcome was unknown.            Concomitant medications include Blood pressure medication. No treatment information was provided.   This case was linked to MOD-2021-405732, MOD-2021-405734 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: nauseous; This spontaneous case was reported by an other health care professional and describes the occurrence of NAUSEA (nauseous) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NAUSEA (nauseous). At the time of the report, NAUSEA (nauseous) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.   This case was linked to MOD-2021-162182, MOD-2021-162197 (Patient Link).
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Little sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Little sore arm) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012H21B, 007M20A and 030A21A) for COVID-19 vaccination.     The patient's past medical history included Tracheostomy (Tracheotomy on neck.). Concurrent medical conditions included Diabetes, Blood pressure high and Lung disorder NOS. Concomitant products included VITAMIN D [VITAMIN D NOS] and VITAMIN B [VITAMIN B NOS] for an unknown indication.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Little sore arm). At the time of the report, VACCINATION SITE PAIN (Little sore arm) had resolved.            Concomitant medications reported also included medication for sugar, medication for high blood pressure and four different inhalers for lung problems.  No treatment medication was provided.   This case was linked to MOD-2021-405078, MOD-2021-405059 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: Received full dose instead of half dose as booster; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL OVERDOSE (Received full dose instead of half dose as booster) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ACCIDENTAL OVERDOSE (Received full dose instead of half dose as booster). At the time of the report, ACCIDENTAL OVERDOSE (Received full dose instead of half dose as booster) had resolved.            No concomitant medications reported by reporter No treatment medications provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Illness, Movement disorder
Clinical narrative: felt sick but she has no fever; could not move said that it lasted for 24 hours; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (felt sick but she has no fever) and MOVEMENT DISORDER (could not move said that it lasted for 24 hours) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included INSULIN for an unknown indication.    On 25-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, the patient experienced ILLNESS (felt sick but she has no fever) and MOVEMENT DISORDER (could not move said that it lasted for 24 hours). On 26-Feb-2021, MOVEMENT DISORDER (could not move said that it lasted for 24 hours) had resolved. At the time of the report, ILLNESS (felt sick but she has no fever) outcome was unknown.            No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Migraine
Clinical narrative: Migraine headache; This spontaneous case was reported by an other health care professional and describes the occurrence of MIGRAINE (Migraine headache) 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 04-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 MIGRAINE (Migraine headache). At the time of the report, MIGRAINE (Migraine headache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient was told to take Tylenol and wants to know whether ibuprofen  can be taken for migraine headache .  Concomitant medication use was unknown.  Treatment information was unknown.   Reporter did not allow further contact
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: left shoulder swelled up a little bit after the 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (left shoulder swelled up a little bit after the 2nd dose) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 041L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-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 SWELLING (left shoulder swelled up a little bit after the 2nd dose). At the time of the report, SWELLING (left shoulder swelled up a little bit after the 2nd dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.   This case was linked to MOD-2021-405240 (Patient Link).
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Pyrexia, Vaccination site movement impairment
Clinical narrative: Low grade fever; Patient felt tired; severe shoulder pain that leave the patient to limited to No range of motion; severe shoulder pain that leave the patient to limited to No range of motion; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (severe shoulder pain that leave the patient to limited to No range of motion), ARTHRALGIA (severe shoulder pain that leave the patient to limited to No range of motion), PYREXIA (Low grade fever) and FATIGUE (Patient felt tired) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Dec-2021, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (severe shoulder pain that leave the patient to limited to No range of motion) and ARTHRALGIA (severe shoulder pain that leave the patient to limited to No range of motion). On an unknown date, the patient experienced PYREXIA (Low grade fever) and FATIGUE (Patient felt tired). At the time of the report, VACCINATION SITE MOVEMENT IMPAIRMENT (severe shoulder pain that leave the patient to limited to No range of motion), ARTHRALGIA (severe shoulder pain that leave the patient to limited to No range of motion), PYREXIA (Low grade fever) and FATIGUE (Patient felt tired) outcome was unknown.            Concomitant medications were not provided. Treatment information include OTC pain killer for severe shoulder pain that leave the patient to limited to No range of motion.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Blood potassium increased, Muscular weakness, Musculoskeletal stiffness, Myalgia, Pain in extremity
Clinical narrative: muscles felt weak; muscles felt a bit tender; the left arm felt like it had had a shot, it was a little bit sore; left arm was a little bit swollen; clavicle area started to swelled up on the opposite side from the shot, from the neck all the way down. it was super-swollen.; neck was stiff; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (neck was stiff), SWELLING (clavicle area started to swelled up on the opposite side from the shot, from the neck all the way down. it was super-swollen.), MUSCULAR WEAKNESS (muscles felt weak), MYALGIA (muscles felt a bit tender) and PAIN IN EXTREMITY (the left arm felt like it had had a shot, it was a little bit sore) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Migraine. Concomitant products included TOPIRAMATE (TOPAMAX) for Migraine, BUPROPION HYDROCHLORIDE (WELLBUTRIN) and VITAMINS NOS for an unknown indication.    On 12-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Dec-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (neck was stiff). On 02-Dec-2021, the patient experienced SWELLING (clavicle area started to swelled up on the opposite side from the shot, from the neck all the way down. it was super-swollen.). On 05-Dec-2021, the patient experienced MUSCULAR WEAKNESS (muscles felt weak), MYALGIA (muscles felt a bit tender), PAIN IN EXTREMITY (the left arm felt like it had had a shot, it was a little bit sore) and PERIPHERAL SWELLING (left arm was a little bit swollen). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, MUSCULOSKELETAL STIFFNESS (neck was stiff), SWELLING (clavicle area started to swelled up on the opposite side from the shot, from the neck all the way down. it was super-swollen.), MUSCULAR WEAKNESS (muscles felt weak), MYALGIA (muscles felt a bit tender), PAIN IN EXTREMITY (the left arm felt like it had had a shot, it was a little bit sore) and PERIPHERAL SWELLING (left arm was a little bit swollen) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood potassium increased: high (High) high.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient consulted with their HCP, who indicated a sonogram of the head and neck area.  Patient is scheduled to get the Moderna second dose on Friday 10Dec2021 and wonder if they should get it, wait or not get it at all.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Swelling
Clinical narrative: muscles felt weak; muscles felt a bit tender; the left arm felt like it had had a shot, it was a little bit sore; left arm was a little bit swollen; clavicle area started to swelled up on the opposite side from the shot, from the neck all the way down. it was super-swollen.; neck was stiff; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (neck was stiff), SWELLING (clavicle area started to swelled up on the opposite side from the shot, from the neck all the way down. it was super-swollen.), MUSCULAR WEAKNESS (muscles felt weak), MYALGIA (muscles felt a bit tender) and PAIN IN EXTREMITY (the left arm felt like it had had a shot, it was a little bit sore) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Migraine. Concomitant products included TOPIRAMATE (TOPAMAX) for Migraine, BUPROPION HYDROCHLORIDE (WELLBUTRIN) and VITAMINS NOS for an unknown indication.    On 12-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Dec-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (neck was stiff). On 02-Dec-2021, the patient experienced SWELLING (clavicle area started to swelled up on the opposite side from the shot, from the neck all the way down. it was super-swollen.). On 05-Dec-2021, the patient experienced MUSCULAR WEAKNESS (muscles felt weak), MYALGIA (muscles felt a bit tender), PAIN IN EXTREMITY (the left arm felt like it had had a shot, it was a little bit sore) and PERIPHERAL SWELLING (left arm was a little bit swollen). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, MUSCULOSKELETAL STIFFNESS (neck was stiff), SWELLING (clavicle area started to swelled up on the opposite side from the shot, from the neck all the way down. it was super-swollen.), MUSCULAR WEAKNESS (muscles felt weak), MYALGIA (muscles felt a bit tender), PAIN IN EXTREMITY (the left arm felt like it had had a shot, it was a little bit sore) and PERIPHERAL SWELLING (left arm was a little bit swollen) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood potassium increased: high (High) high.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient consulted with their HCP, who indicated a sonogram of the head and neck area.  Patient is scheduled to get the Moderna second dose on Friday 10Dec2021 and wonder if they should get it, wait or not get it at all.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Hypersensitivity, Rash, Urticaria
Clinical narrative: Hives; Feeling terrible; Allergic reaction; Rash; Chills; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives), FEELING ABNORMAL (Feeling terrible), HYPERSENSITIVITY (Allergic reaction), RASH (Rash) and CHILLS (Chills) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045J21A, 04821A and 019B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Dec-2021, the patient experienced URTICARIA (Hives), FEELING ABNORMAL (Feeling terrible), HYPERSENSITIVITY (Allergic reaction), RASH (Rash) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency and DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, EPHEDRINE SULFATE, ETHANOL, PARACETAMOL (NYQUIL) for Adverse event, at an unspecified dose and frequency. At the time of the report, URTICARIA (Hives), FEELING ABNORMAL (Feeling terrible), HYPERSENSITIVITY (Allergic reaction), RASH (Rash) and CHILLS (Chills) 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.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired doses administered to 8 patients; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired doses administered to 8 patients) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) 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) (Intramuscular) 1 dosage form. On 03-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired doses administered to 8 patients). On 03-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Expired doses administered to 8 patients) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported  No treatment information was provided  Total 8 doses from 1 vial  was administered out of 8 doses 7 was booster doses, and 1 was regular dose.
Sex: U
Vaccine: COVID19
Symptoms: Hypersensitivity, Urticaria
Clinical narrative: hives; allergies; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives) and HYPERSENSITIVITY (allergies) 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,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced URTICARIA (hives) and HYPERSENSITIVITY (allergies). At the time of the report, URTICARIA (hives) and HYPERSENSITIVITY (allergies) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.   This case was linked to MOD21-169582 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: Patient first received the Moderna booster shot last Dec.1 and then accidentally was given another booster shot today Dec. 6; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL OVERDOSE (Patient first received the Moderna booster shot last Dec.1 and then accidentally was given another booster shot today Dec. 6) 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 01-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Dec-2021, the patient experienced ACCIDENTAL OVERDOSE (Patient first received the Moderna booster shot last Dec.1 and then accidentally was given another booster shot today Dec. 6). On 06-Dec-2021, ACCIDENTAL OVERDOSE (Patient first received the Moderna booster shot last Dec.1 and then accidentally was given another booster shot today Dec. 6) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were reported.  Patient was suppose to receive a Flu shot today but the nurse accidentally administered Moderna booster shot instead of the Flu shot.
Sex: U
Vaccine: COVID19
Symptoms: Muscle spasms, Vaccination complication
Clinical narrative: charlie horse leg cramps; leg cramps; some side effects; This spontaneous case was reported by an other health care professional and describes the occurrence of MUSCLE SPASMS (charlie horse leg cramps), MUSCLE SPASMS (leg cramps) and VACCINATION COMPLICATION (some side effects) 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 (charlie horse leg cramps), MUSCLE SPASMS (leg cramps) and VACCINATION COMPLICATION (some side effects). At the time of the report, MUSCLE SPASMS (charlie horse leg cramps), MUSCLE SPASMS (leg cramps) and VACCINATION COMPLICATION (some side effects) 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 medication was reported.     No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: gave second dose at day 11; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (gave second dose at day 11) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, 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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (gave second dose at day 11). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (gave second dose at day 11) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Erythema, Neck pain
Clinical narrative: extreme neck pain; redness all the way down the arm; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (extreme neck pain) and ERYTHEMA (redness all the way down the arm) 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 NECK PAIN (extreme neck pain) and ERYTHEMA (redness all the way down the arm). At the time of the report, NECK PAIN (extreme neck pain) and ERYTHEMA (redness all the way down the arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported   No treatment information was provided
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Fall, Fatigue, Gait disturbance
Clinical narrative: weak, is sleeping all the time; weak, is sleeping all the time; has to use a cane to walk, which he didn't used to before.; dizzy, which is not normal for him; started experiencing tiredness and went to lie down; He has fallen 4 times since receiving the booster dose; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weak, is sleeping all the time), SOMNOLENCE (weak, is sleeping all the time), FALL (He has fallen 4 times since receiving the booster dose), GAIT DISTURBANCE (has to use a cane to walk, which he didn't used to before.) and DIZZINESS (dizzy, which is not normal for him) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058H21A and 019B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included TIA (He was hospitalized 3 times in 2019 due to the TIAs) in July 2019. Concurrent medical conditions included Grand mal seizure since July 2020. Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID], ATORVASTATIN, COLECALCIFEROL (VITAMIN D3), DOCUSATE SODIUM (COLACE), LEVETIRACETAM (KEPPRA [LEVETIRACETAM]), PHENYTOIN (DILANTIN [PHENYTOIN]) and POTASSIUM CHLORIDE for an unknown indication.   On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-May-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 02-Dec-2021, the patient experienced FALL (He has fallen 4 times since receiving the booster dose), DIZZINESS (dizzy, which is not normal for him) and FATIGUE (started experiencing tiredness and went to lie down). On an unknown date, the patient experienced ASTHENIA (weak, is sleeping all the time), SOMNOLENCE (weak, is sleeping all the time) and GAIT DISTURBANCE (has to use a cane to walk, which he didn't used to before.). At the time of the report, ASTHENIA (weak, is sleeping all the time), SOMNOLENCE (weak, is sleeping all the time), FALL (He has fallen 4 times since receiving the booster dose), GAIT DISTURBANCE (has to use a cane to walk, which he didn't used to before.), DIZZINESS (dizzy, which is not normal for him) and FATIGUE (started experiencing tiredness and went to lie down) outcome was unknown.            No treatment medications were reported.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: weak, is sleeping all the time; weak, is sleeping all the time; has to use a cane to walk, which he didn't used to before.; dizzy, which is not normal for him; started experiencing tiredness and went to lie down; He has fallen 4 times since receiving the booster dose; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weak, is sleeping all the time), SOMNOLENCE (weak, is sleeping all the time), FALL (He has fallen 4 times since receiving the booster dose), GAIT DISTURBANCE (has to use a cane to walk, which he didn't used to before.) and DIZZINESS (dizzy, which is not normal for him) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058H21A and 019B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included TIA (He was hospitalized 3 times in 2019 due to the TIAs) in July 2019. Concurrent medical conditions included Grand mal seizure since July 2020. Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID], ATORVASTATIN, COLECALCIFEROL (VITAMIN D3), DOCUSATE SODIUM (COLACE), LEVETIRACETAM (KEPPRA [LEVETIRACETAM]), PHENYTOIN (DILANTIN [PHENYTOIN]) and POTASSIUM CHLORIDE for an unknown indication.   On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-May-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 02-Dec-2021, the patient experienced FALL (He has fallen 4 times since receiving the booster dose), DIZZINESS (dizzy, which is not normal for him) and FATIGUE (started experiencing tiredness and went to lie down). On an unknown date, the patient experienced ASTHENIA (weak, is sleeping all the time), SOMNOLENCE (weak, is sleeping all the time) and GAIT DISTURBANCE (has to use a cane to walk, which he didn't used to before.). At the time of the report, ASTHENIA (weak, is sleeping all the time), SOMNOLENCE (weak, is sleeping all the time), FALL (He has fallen 4 times since receiving the booster dose), GAIT DISTURBANCE (has to use a cane to walk, which he didn't used to before.), DIZZINESS (dizzy, which is not normal for him) and FATIGUE (started experiencing tiredness and went to lie down) outcome was unknown.            No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Urgent adverse effect; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Urgent 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 (Urgent adverse effect). At the time of the report, VACCINATION COMPLICATION (Urgent 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: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Shingles after 2nd dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     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 HERPES ZOSTER (Shingles after 2nd dose). At the time of the report, HERPES ZOSTER (Shingles after 2nd dose) outcome was unknown.            No concomitant medications were provided. No treatment information were provided.   This case was linked to MOD-2021-405216 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: internal itching; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (internal itching) 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 PRURITUS (internal itching). At the time of the report, PRURITUS (internal itching) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported. No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Dysstasia, Myalgia, Pain in extremity
Clinical narrative: I cannot stand for 10 minutes; Pain from my hips to feet; Pain from my hips; Had extensive body aches; This spontaneous case was reported by a nurse and describes the occurrence of DYSSTASIA (I cannot stand for 10 minutes), PAIN IN EXTREMITY (Pain from my hips to feet), ARTHRALGIA (Pain from my hips) and MYALGIA (Had extensive body aches) 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) (unknown route) 1 dosage form. In November 2021, the patient experienced ARTHRALGIA and MYALGIA. On an unknown date, the patient experienced DYSSTASIA and PAIN IN EXTREMITY. In November 2021, MYALGIA had resolved. At the time of the report, DYSSTASIA, PAIN IN EXTREMITY and ARTHRALGIA outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.                             Treatment information was not provided by the reporter.  2 weeks before reporting patient received Moderna booster vaccine. and the following week patient experienced pain from my hips to feet and was not able to stand for 10 minutes was always in pain.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Inappropriate schedule of product administration, Nausea
Clinical narrative: Felt nauseous; Felt tired; Inappropriate schedule of vaccine administered; Bad headaches 2 hours after the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Bad headaches 2 hours after the vaccine), NAUSEA (Felt nauseous), FATIGUE (Felt tired) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for COVID-19 vaccination: Pfizer Vaccine. Past adverse reactions to the above products included No adverse event with Pfizer Vaccine.    On 29-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HEADACHE (Bad headaches 2 hours after the vaccine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On an unknown date, the patient experienced NAUSEA (Felt nauseous) and FATIGUE (Felt tired). The patient was treated with PARACETAMOL (TYLENOL 8 HOUR) for Headache, at an unspecified dose and frequency. On 29-Nov-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved. At the time of the report, HEADACHE (Bad headaches 2 hours after the vaccine), NAUSEA (Felt nauseous) and FATIGUE (Felt tired) outcome was unknown.            No concomitant medications were reported.  The reporter thinks the patient received full dose for their booster dose. Patient received primary series of the Pfizer Covid-19 vaccine.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pain
Clinical narrative: Achiness; Chills; This spontaneous case was reported by a physician and describes the occurrence of PAIN (Achiness) and CHILLS (Chills) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (One year ago) in 2020.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (Achiness) and CHILLS (Chills). At the time of the report, PAIN (Achiness) and CHILLS (Chills) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  Treatment medications were not reported.   This case was linked to MOD-2021-405275 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: felt tired after her second Moderna Covid-19 vaccine.; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (felt tired after her second Moderna Covid-19 vaccine.) 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, the patient experienced FATIGUE (felt tired after her second Moderna Covid-19 vaccine.). At the time of the report, FATIGUE (felt tired after her second Moderna Covid-19 vaccine.) outcome was unknown.            No concomitant drug details were reported. No treatment details were reported.    Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: soreness of the arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness of the arm) 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 01-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Dec-2021, the patient experienced PAIN IN EXTREMITY (soreness of the arm). At the time of the report, PAIN IN EXTREMITY (soreness of the arm) outcome was unknown.            No concomitant medications provided. No treatment medications provided.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: really intense hives for 10 days now./ hives now spread to her body; woke up with really intense itching on her head / really intense itching behind her ears; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (really intense hives for 10 days now./ hives now spread to her body) and PRURITUS (woke up with really intense itching on her head / really intense itching behind her ears) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A, 018B21A and 013F21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE, ETHINYLESTRADIOL, NORETHISTERONE ACETATE (LOESTRIN), SPIRONOLACTONE and METFORMIN for an unknown indication.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Nov-2021, the patient experienced URTICARIA (really intense hives for 10 days now./ hives now spread to her body) and PRURITUS (woke up with really intense itching on her head / really intense itching behind her ears). At the time of the report, URTICARIA (really intense hives for 10 days now./ hives now spread to her body) and PRURITUS (woke up with really intense itching on her head / really intense itching behind her ears) outcome was unknown.            Treatment medication include two oatmeal baths a day to calm the skin ,two urgent care and two allergist.