chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Nasopharyngitis
Clinical narrative: "feel like i'm coming down with a cold"; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS ("feel like i'm coming down with a cold") in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NASOPHARYNGITIS ("feel like i'm coming down with a cold"). At the time of the report, NASOPHARYNGITIS ("feel like i'm coming down with a cold") outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient experienced cold two weeks prior to first dose. Concomitant medications were not reported. Treatment details were not reported.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Depressed mood, Dizziness, Dysstasia, Paraesthesia
Clinical narrative: dizzy; feeling of beginning to fall; tingly toes and legs; could not stand on her legs, did not feel well legs don't feel right; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizzy), DEPRESSED MOOD (feeling of beginning to fall), PARAESTHESIA (tingly toes and legs) and DYSSTASIA (could not stand on her legs, did not feel well legs don't feel right) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included GLIPIZIDE for Diabetes mellitus, MECLOZINE HYDROCHLORIDE (MECLIZINE [MECLOZINE HYDROCHLORIDE]) for Dizziness, METFORMIN, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), PREDNISOLONE and CEFALEXIN MONOHYDRATE (KEFLEX [CEFALEXIN MONOHYDRATE]) for an unknown indication.    On 17-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-May-2021, the patient experienced DIZZINESS (dizzy), DEPRESSED MOOD (feeling of beginning to fall), PARAESTHESIA (tingly toes and legs) and DYSSTASIA (could not stand on her legs, did not feel well legs don't feel right). The patient was treated with SALINE [SODIUM CHLORIDE] (intravenous) at an unspecified dose and frequency. On 25-May-2021, DIZZINESS (dizzy), DEPRESSED MOOD (feeling of beginning to fall), PARAESTHESIA (tingly toes and legs) and DYSSTASIA (could not stand on her legs, did not feel well legs don't feel right) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The treatment medication was antibiotic.   Most recent FOLLOW-UP information incorporated above includes: On 09-Jun-2021: Follow up received and contains No new information.
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: 1st dose 50 days ago; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (1st dose 50 days ago) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (1st dose 50 days ago). At the time of the report, PRODUCT DOSE OMISSION ISSUE (1st dose 50 days ago) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medications were reported. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 09-Jun-2021: On 09-Jun-2021, follow up document was attached which contains no new information.
Sex: U
Vaccine: COVID19
Symptoms: Constipation
Clinical narrative: Constipation; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of CONSTIPATION (Constipation) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CONSTIPATION (Constipation). At the time of the report, CONSTIPATION (Constipation) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Oral herpes
Clinical narrative: fever blister; cold sore; This spontaneous case was reported by a consumer and describes the occurrence of ORAL HERPES (fever blister) and ORAL HERPES (cold sore) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history provided.     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 ORAL HERPES (fever blister) and ORAL HERPES (cold sore). At the time of the report, ORAL HERPES (fever blister) and ORAL HERPES (cold sore) outcome was unknown.            No treatment medication provided. No concomitant medication provided.   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Heart rate, Hypersensitivity
Clinical narrative: experiencing difficulty of breathing; allergic reaction; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (experiencing difficulty of breathing) and HYPERSENSITIVITY (allergic reaction) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 21-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-May-2021, the patient experienced DYSPNOEA (experiencing difficulty of breathing) and HYPERSENSITIVITY (allergic reaction). At the time of the report, DYSPNOEA (experiencing difficulty of breathing) and HYPERSENSITIVITY (allergic reaction) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-May-2021, Heart rate: high (High) heart rate is high.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity
Clinical narrative: sore arm; body aches; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) and MYALGIA (body aches) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 3002331) for COVID-19 immunisation.     No Medical History information was reported.    On 13-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-May-2021, the patient experienced PAIN IN EXTREMITY (sore arm) and MYALGIA (body aches). On 15-May-2021, PAIN IN EXTREMITY (sore arm) and MYALGIA (body aches) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no treatment and concomitant medication reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: vaccine was administered just outside the 12 hour window once it was punctured to patient; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine was administered just outside the 12 hour window once it was punctured to patient) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine was administered just outside the 12 hour window once it was punctured to patient). At the time of the report, EXPIRED PRODUCT ADMINISTERED (vaccine was administered just outside the 12 hour window once it was punctured to patient) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Med Info Agent:  AE Submitted via agency   Reporter did not allow further contact
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Product dose omission issue
Clinical narrative: Missed to take Second dose of Covid-19 Vaccine exceeded 90 days; Sore arm with first dose; This spontaneous case was reported by a nurse and describes the occurrence of PAIN IN EXTREMITY (Sore arm with first dose) and PRODUCT DOSE OMISSION ISSUE (Missed to take Second dose of Covid-19 Vaccine exceeded 90 days) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm with first dose). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed to take Second dose of Covid-19 Vaccine exceeded 90 days). At the time of the report, PAIN IN EXTREMITY (Sore arm with first dose) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Missed to take Second dose of Covid-19 Vaccine exceeded 90 days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 45 patient were vaccinated by vaccine after 39 days storage in refrigerator; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (45 patient were vaccinated by vaccine after 39 days storage in refrigerator) 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 was provided by the reporter.     On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (45 patient were vaccinated by vaccine after 39 days storage in refrigerator). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (45 patient were vaccinated by vaccine after 39 days storage in refrigerator) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.   Reporter did not allow further contact
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hot flush, Hyperthermia, Myalgia
Clinical narrative: Over heating; Headache/Bursting pain in left side of head; Body aches; Hot flushes/Little bit different than normal ones,come fast and go fast.; This spontaneous case was reported by a consumer and describes the occurrence of HOT FLUSH (Hot flushes/Little bit different than normal ones,come fast and go fast.), HYPERTHERMIA (Over heating), HEADACHE (Headache/Bursting pain in left side of head) and MYALGIA (Body aches) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041B21A and 041B21A) for COVID-19 vaccination.     Concomitant products included THYROID (ARMOUR THYROID) for Thyroid disorder.   On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-May-2021, the patient experienced HOT FLUSH (Hot flushes/Little bit different than normal ones,come fast and go fast.). On an unknown date, the patient experienced HYPERTHERMIA (Over heating), HEADACHE (Headache/Bursting pain in left side of head) and MYALGIA (Body aches). The patient was treated with IBUPROFEN for Headache, at an unspecified dose and frequency. At the time of the report, HOT FLUSH (Hot flushes/Little bit different than normal ones,come fast and go fast.), HYPERTHERMIA (Over heating), HEADACHE (Headache/Bursting pain in left side of head) and MYALGIA (Body aches) outcome was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Muscle spasms
Clinical narrative: muscle cramps; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (muscle cramps) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MUSCLE SPASMS (muscle cramps). At the time of the report, MUSCLE SPASMS (muscle cramps) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided.  Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Depressed mood, Feeling abnormal, Illness
Clinical narrative: Put completely down; Soo sick; Feel real bad; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of DEPRESSED MOOD (Put completely down), ILLNESS (Soo sick) and FEELING ABNORMAL (Feel real bad) 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 24-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DEPRESSED MOOD (Put completely down), ILLNESS (Soo sick) and FEELING ABNORMAL (Feel real bad). At the time of the report, DEPRESSED MOOD (Put completely down), ILLNESS (Soo sick) and FEELING ABNORMAL (Feel real bad) outcome was unknown.            No concomitant medication information was provided No treatment medication information was provided
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Pain in extremity, Pyrexia, Vitreous floaters
Clinical narrative: floaters in her left eye which are still there; Fever; sore arm; very tired and run down afterwards; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VITREOUS FLOATERS (floaters in her left eye which are still there), FATIGUE (very tired and run down afterwards), MYALGIA (sore arm), PYREXIA (Fever) and PAIN IN EXTREMITY (sore arm) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031B21A and 006C21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 31-Mar-2021, the patient experienced FATIGUE (very tired and run down afterwards), MYALGIA (sore arm) and PAIN IN EXTREMITY (sore arm). On 30-Apr-2021, the patient experienced PYREXIA (Fever). On 01-May-2021, the patient experienced VITREOUS FLOATERS (floaters in her left eye which are still there). On 01-Apr-2021, FATIGUE (very tired and run down afterwards), MYALGIA (sore arm) and PAIN IN EXTREMITY (sore arm) had resolved. On 01-May-2021, PYREXIA (Fever) had resolved. At the time of the report, VITREOUS FLOATERS (floaters in her left eye which are still there) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported by the reporter.   No treatment medications provided by the reporter.   This case was linked to MOD-2021-176004 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Chills, Dizziness, Headache
Clinical narrative: Dizziness; Headaches; Chills; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), HEADACHE (Headaches) and CHILLS (Chills) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unkown) 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 DIZZINESS (Dizziness), HEADACHE (Headaches) and CHILLS (Chills). At the time of the report, DIZZINESS (Dizziness), HEADACHE (Headaches) and CHILLS (Chills) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable.  No concomitant medications were reported. Treatment information was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Feeling ache and pains; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Feeling ache and pains) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN (Feeling ache and pains). At the time of the report, PAIN (Feeling ache and pains) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment was reported.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Bowel movement irregularity
Clinical narrative: unexpected bowel movement; This spontaneous case was reported by a consumer and describes the occurrence of BOWEL MOVEMENT IRREGULARITY (unexpected bowel movement) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included GERD, COPD and Pneumonectomy (Lung removed). Concomitant products included OMEPRAZOLE for an unknown indication.    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 BOWEL MOVEMENT IRREGULARITY (unexpected bowel movement). At the time of the report, BOWEL MOVEMENT IRREGULARITY (unexpected bowel movement) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Rhinorrhoea
Clinical narrative: Have running nose; Weakness; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (Have running nose) and ASTHENIA (Weakness) 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 21-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-May-2021, the patient experienced RHINORRHOEA (Have running nose) and ASTHENIA (Weakness). At the time of the report, RHINORRHOEA (Have running nose) and ASTHENIA (Weakness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication list was not provided. Treatment information was not provided.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pyrexia, Vitreous floaters
Clinical narrative: floaters in her left eye which are still there; very tired and run down that night; fever; headache; This spontaneous case was reported by a consumer and describes the occurrence of VITREOUS FLOATERS (floaters in her left eye which are still there), FATIGUE (very tired and run down that night), PYREXIA (fever) and HEADACHE (headache) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-2021, the patient experienced FATIGUE (very tired and run down that night), PYREXIA (fever) and HEADACHE (headache). On 01-May-2021, the patient experienced VITREOUS FLOATERS (floaters in her left eye which are still there). On 01-May-2021, FATIGUE (very tired and run down that night), PYREXIA (fever) and HEADACHE (headache) had resolved. At the time of the report, VITREOUS FLOATERS (floaters in her left eye which are still there) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-175972 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: muscle pain; Med Info Agent:  Customer care transferred the Case# 00169419 Patient said he received his first vaccine on 4May2021, but before this he recovered from Covid-19 in March. After receiving his first vaccine he experienced muscle pain. He said he will receive his second vaccine on 4Jun2021. He was asking after his second vaccine, how long he should wait to interact with her girlfriend.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Influenza like illness, No adverse event, Product temperature excursion issue
Clinical narrative: Administered vaccine after temperature excursion; No adverse reactions reported after first dose; gave moderna vaccine from a punctured vial eft out more than 12 hours/doses from vial that had been punctured for more than 12 hours; Flu-like symptoms within four hours of the administration; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Administered vaccine after temperature excursion), EXPIRED PRODUCT ADMINISTERED (gave moderna vaccine from a punctured vial eft out more than 12 hours/doses from vial that had been punctured for more than 12 hours), INFLUENZA LIKE ILLNESS (Flu-like symptoms within four hours of the administration) and NO ADVERSE EVENT (No adverse reactions reported after first dose) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ATENOLOL, ESCITALOPRAM, OMEPRAZOLE, PRAZOSIN and SALBUTAMOL for an unknown indication.   On 01-Jan-1900, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (gave moderna vaccine from a punctured vial eft out more than 12 hours/doses from vial that had been punctured for more than 12 hours) and INFLUENZA LIKE ILLNESS (Flu-like symptoms within four hours of the administration). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Administered vaccine after temperature excursion) and NO ADVERSE EVENT (No adverse reactions reported after first dose). At the time of the report, EXPIRED PRODUCT ADMINISTERED (gave moderna vaccine from a punctured vial eft out more than 12 hours/doses from vial that had been punctured for more than 12 hours), INFLUENZA LIKE ILLNESS (Flu-like symptoms within four hours of the administration) and NO ADVERSE EVENT (No adverse reactions reported after first dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: Follow-up was received on 26-05-2021 and included new information batch number,AE On 28-May-2021: Follow-up was received on 1-06-2021 and included no new information. On 01-Jun-2021: Follow-up was received on 1-06-2021 and included no new information. On 01-Jun-2021: Follow-up was received on 1-06-2021 and included no new information. On 01-Jun-2021: Follow-up was received on 1-06-2021 and included no new information. On 01-Jun-2021: No specific follow-up information recorded.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever). At the time of the report, PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant  medication were not provided.  Treatment information were not provided.   Reporter did not allow further contact
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Mouth swelling, Swelling, Swelling face
Clinical narrative: swollen neck; swollen mouth; swollen face; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (swollen neck), MOUTH SWELLING (swollen mouth) and SWELLING FACE (swollen face) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination.     The patient's past medical history included Surgery. Concomitant products included LISINOPRIL, METOPROLOL and EPINEPHRINE (EPIPEN) for an unknown indication.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Mar-2021, the patient experienced SWELLING (swollen neck), MOUTH SWELLING (swollen mouth) and SWELLING FACE (swollen face). At the time of the report, SWELLING (swollen neck), MOUTH SWELLING (swollen mouth) and SWELLING FACE (swollen face) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information reported by the reporter  It was reported that the patient was kept on going with words like her epipen was costing a lot and she wanted information on reimbursement. She also mentioned something about surgery. Did not clarify what kind of surgery but said something like she was not sure if surgery was because of the vaccine.   Most recent FOLLOW-UP information incorporated above includes: On 04-Aug-2021: Non-significant follow up appended On 04-Aug-2021: Significant follow up. Narrative details updated. Concomitant medication was added. Procedure was added.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Dry mouth, Hyperhidrosis, Joint swelling, Myalgia
Clinical narrative: Extremely dry mouth; Both ankles are swollen/The left is worst. It's really, really bad.; Body aches; The sweats; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (The sweats), DRY MOUTH (Extremely dry mouth), JOINT SWELLING (Both ankles are swollen/The left is worst. It's really, really bad.) and MYALGIA (Body aches) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included OLANZAPINE.    On 19-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-May-2021, the patient experienced HYPERHIDROSIS (The sweats) and MYALGIA (Body aches). On 25-May-2021, the patient experienced DRY MOUTH (Extremely dry mouth) and JOINT SWELLING (Both ankles are swollen/The left is worst. It's really, really bad.). At the time of the report, HYPERHIDROSIS (The sweats), DRY MOUTH (Extremely dry mouth), JOINT SWELLING (Both ankles are swollen/The left is worst. It's really, really bad.) and MYALGIA (Body aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 09-Jun-2021: Consumer stated does not have an email address or fax number. She is not interested in providing additional information regarding adverse event.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Bedridden, Chills, Diarrhoea, Dizziness
Clinical narrative: She had diarrhea; As of now, she feels dizzy; nausea; chills; 6 days later, she had fatigue; Fever; She also says that when she coughs, she coughs spots of blood; when she sneezes, she sneezes spots of blood; She was bed-ridden for 3 days; She started with back ache 5 days after receiving 1st dose; She had muscle aches; This spontaneous case was reported by a patient and describes the occurrence of BACK PAIN (She started with back ache 5 days after receiving 1st dose), HAEMOPTYSIS (She also says that when she coughs, she coughs spots of blood), EPISTAXIS (when she sneezes, she sneezes spots of blood), BEDRIDDEN (She was bed-ridden for 3 days) and DIARRHOEA (She had diarrhea) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history reported.  Concomitant products included LEVOTHYROXINE for an unknown indication.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced BACK PAIN (She started with back ache 5 days after receiving 1st dose), BEDRIDDEN (She was bed-ridden for 3 days) and MYALGIA (She had muscle aches). On 30-Mar-2021, the patient experienced HAEMOPTYSIS (She also says that when she coughs, she coughs spots of blood), EPISTAXIS (when she sneezes, she sneezes spots of blood), NAUSEA (nausea), CHILLS (chills), FATIGUE (6 days later, she had fatigue) and PYREXIA (Fever). On 05-Apr-2021, the patient experienced DIZZINESS (As of now, she feels dizzy). On an unknown date, the patient experienced DIARRHOEA (She had diarrhea). The patient was treated with ACETAMINOPHEN for Symptomatic treatment, at an unspecified dose and frequency. At the time of the report, BACK PAIN (She started with back ache 5 days after receiving 1st dose), HAEMOPTYSIS (She also says that when she coughs, she coughs spots of blood), EPISTAXIS (when she sneezes, she sneezes spots of blood), BEDRIDDEN (She was bed-ridden for 3 days), DIARRHOEA (She had diarrhea), DIZZINESS (As of now, she feels dizzy), NAUSEA (nausea), CHILLS (chills), FATIGUE (6 days later, she had fatigue), PYREXIA (Fever) and MYALGIA (She had muscle aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis, Fatigue, Haemoptysis, Myalgia, Nausea
Clinical narrative: She had diarrhea; As of now, she feels dizzy; nausea; chills; 6 days later, she had fatigue; Fever; She also says that when she coughs, she coughs spots of blood; when she sneezes, she sneezes spots of blood; She was bed-ridden for 3 days; She started with back ache 5 days after receiving 1st dose; She had muscle aches; This spontaneous case was reported by a patient and describes the occurrence of BACK PAIN (She started with back ache 5 days after receiving 1st dose), HAEMOPTYSIS (She also says that when she coughs, she coughs spots of blood), EPISTAXIS (when she sneezes, she sneezes spots of blood), BEDRIDDEN (She was bed-ridden for 3 days) and DIARRHOEA (She had diarrhea) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history reported.  Concomitant products included LEVOTHYROXINE for an unknown indication.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced BACK PAIN (She started with back ache 5 days after receiving 1st dose), BEDRIDDEN (She was bed-ridden for 3 days) and MYALGIA (She had muscle aches). On 30-Mar-2021, the patient experienced HAEMOPTYSIS (She also says that when she coughs, she coughs spots of blood), EPISTAXIS (when she sneezes, she sneezes spots of blood), NAUSEA (nausea), CHILLS (chills), FATIGUE (6 days later, she had fatigue) and PYREXIA (Fever). On 05-Apr-2021, the patient experienced DIZZINESS (As of now, she feels dizzy). On an unknown date, the patient experienced DIARRHOEA (She had diarrhea). The patient was treated with ACETAMINOPHEN for Symptomatic treatment, at an unspecified dose and frequency. At the time of the report, BACK PAIN (She started with back ache 5 days after receiving 1st dose), HAEMOPTYSIS (She also says that when she coughs, she coughs spots of blood), EPISTAXIS (when she sneezes, she sneezes spots of blood), BEDRIDDEN (She was bed-ridden for 3 days), DIARRHOEA (She had diarrhea), DIZZINESS (As of now, she feels dizzy), NAUSEA (nausea), CHILLS (chills), FATIGUE (6 days later, she had fatigue), PYREXIA (Fever) and MYALGIA (She had muscle aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: She had diarrhea; As of now, she feels dizzy; nausea; chills; 6 days later, she had fatigue; Fever; She also says that when she coughs, she coughs spots of blood; when she sneezes, she sneezes spots of blood; She was bed-ridden for 3 days; She started with back ache 5 days after receiving 1st dose; She had muscle aches; This spontaneous case was reported by a patient and describes the occurrence of BACK PAIN (She started with back ache 5 days after receiving 1st dose), HAEMOPTYSIS (She also says that when she coughs, she coughs spots of blood), EPISTAXIS (when she sneezes, she sneezes spots of blood), BEDRIDDEN (She was bed-ridden for 3 days) and DIARRHOEA (She had diarrhea) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history reported.  Concomitant products included LEVOTHYROXINE for an unknown indication.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced BACK PAIN (She started with back ache 5 days after receiving 1st dose), BEDRIDDEN (She was bed-ridden for 3 days) and MYALGIA (She had muscle aches). On 30-Mar-2021, the patient experienced HAEMOPTYSIS (She also says that when she coughs, she coughs spots of blood), EPISTAXIS (when she sneezes, she sneezes spots of blood), NAUSEA (nausea), CHILLS (chills), FATIGUE (6 days later, she had fatigue) and PYREXIA (Fever). On 05-Apr-2021, the patient experienced DIZZINESS (As of now, she feels dizzy). On an unknown date, the patient experienced DIARRHOEA (She had diarrhea). The patient was treated with ACETAMINOPHEN for Symptomatic treatment, at an unspecified dose and frequency. At the time of the report, BACK PAIN (She started with back ache 5 days after receiving 1st dose), HAEMOPTYSIS (She also says that when she coughs, she coughs spots of blood), EPISTAXIS (when she sneezes, she sneezes spots of blood), BEDRIDDEN (She was bed-ridden for 3 days), DIARRHOEA (She had diarrhea), DIZZINESS (As of now, she feels dizzy), NAUSEA (nausea), CHILLS (chills), FATIGUE (6 days later, she had fatigue), PYREXIA (Fever) and MYALGIA (She had muscle aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Dyspnoea
Clinical narrative: Shortness of breath; Weakness; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness of breath) and ASTHENIA (Weakness) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (Shortness of breath) and ASTHENIA (Weakness). At the time of the report, DYSPNOEA (Shortness of breath) and ASTHENIA (Weakness) outcome was unknown.            no concomitant medication were reported no treatment information was provided   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Eye pain, Myalgia, Ocular discomfort
Clinical narrative: pain like she's getting stuck with needles in her eye; eye pain; severe I'll pain; This spontaneous case was reported by a consumer and describes the occurrence of OCULAR DISCOMFORT (pain like she's getting stuck with needles in her eye), EYE PAIN (eye pain) and MYALGIA (severe I'll pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.    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 OCULAR DISCOMFORT (pain like she's getting stuck with needles in her eye), EYE PAIN (eye pain) and MYALGIA (severe I'll pain). At the time of the report, OCULAR DISCOMFORT (pain like she's getting stuck with needles in her eye), EYE PAIN (eye pain) and MYALGIA (severe I'll pain) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable. Concomitant drug was not reported. Treatment medication was not reported.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: White blood cell count increased
Clinical narrative: white blood cell count increased / elevated blood cells; This spontaneous case was reported by a consumer and describes the occurrence of WHITE BLOOD CELL COUNT INCREASED (white blood cell count increased / elevated blood cells) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Mar-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 WHITE BLOOD CELL COUNT INCREASED (white blood cell count increased / elevated blood cells). At the time of the report, WHITE BLOOD CELL COUNT INCREASED (white blood cell count increased / elevated blood cells) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.        Concomitant product was not provided. treatment medication was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: follow-up was received on 26-05-2021. non significant follow up
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: fever is 100.9; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever is 100.9) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.   On 25-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-May-2021, the patient experienced PYREXIA (fever is 100.9). At the time of the report, PYREXIA (fever is 100.9) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-May-2021, Body temperature: 100.9 (Inconclusive) 100.9.         Concomitant medications were not provided.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not applicable.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Device connection issue, Pain in extremity, Underdose
Clinical narrative: did not receive a full second vaccine dose; left arm painful; did not receive a full second vaccine dose; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (left arm painful), UNDERDOSE (did not receive a full second vaccine dose) and DEVICE CONNECTION ISSUE (did not receive a full second vaccine dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050C21A) for COVID-19 vaccination.     Concomitant products included METFORMIN for an unknown indication.    On 25-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-May-2021, the patient experienced PAIN IN EXTREMITY (left arm painful) and UNDERDOSE (did not receive a full second vaccine dose). On an unknown date, the patient experienced DEVICE CONNECTION ISSUE (did not receive a full second vaccine dose). The patient was treated with PARACETAMOL (TYLENOL) for Pain in arm, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (left arm painful), UNDERDOSE (did not receive a full second vaccine dose) and DEVICE CONNECTION ISSUE (did not receive a full second vaccine dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   concomitant medication include inhaler, Action taken with mRNA-1273 in response to the event was not applicable.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Fatigue, Hyperhidrosis, Myalgia
Clinical narrative: sweats; chills; body aches; fatigue; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (sweats), CHILLS (chills), MYALGIA (body aches) and FATIGUE (fatigue) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 immunisation.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPERHIDROSIS (sweats), CHILLS (chills), MYALGIA (body aches) and FATIGUE (fatigue). At the time of the report, HYPERHIDROSIS (sweats), CHILLS (chills), MYALGIA (body aches) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were reported. No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site induration, Vaccination site pruritus
Clinical narrative: Injection site itching after 10 days; Injection site hard to the feel after 10 days; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Injection site itching after 10 days) and VACCINATION SITE INDURATION (Injection site hard to the feel after 10 days) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PRURITUS (Injection site itching after 10 days) and VACCINATION SITE INDURATION (Injection site hard to the feel after 10 days). At the time of the report, VACCINATION SITE PRURITUS (Injection site itching after 10 days) and VACCINATION SITE INDURATION (Injection site hard to the feel after 10 days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant Medication was provided. No treatment  was provided.  Patient had injection site is itching and hard to the feel after 10 days.   Reporter did not allow further contact