chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Burning sensation, Chills, Decreased appetite, Feeling cold
Clinical narrative: Hyperactive; Could not sit still; Was really hungry; Start sweating; Arms hurting; Body aches / severe body aches; Headache; Low grade temperature; Chills / bad chills; So weak / really weak; Low appetite; Really cold with terrible chills then really hot and sweating; Been really sick for 2 and half days; Really hot/felt like sun burned; Felt like sun burned; This spontaneous case was reported by a consumer and describes the occurrence of PSYCHOMOTOR HYPERACTIVITY (Hyperactive), SITTING DISABILITY (Could not sit still), ASTHENIA (So weak / really weak), DECREASED APPETITE (Low appetite) and FEELING COLD (Really cold with terrible chills then really hot and sweating) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019F21A and 020F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included CLARITHROMYCIN (CLARITIN [CLARITHROMYCIN]), MULTIVITAMIN [VITAMINS NOS], VITAMIN C [ASCORBIC ACID], HYDROCHLOROTHIAZIDE, TELMISARTAN (TELMISARTAN/HCTZ) and AMLODIPINE for an unknown indication.   On 11-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Oct-2021, the patient experienced ASTHENIA (So weak / really weak), DECREASED APPETITE (Low appetite), FEELING COLD (Really cold with terrible chills then really hot and sweating), ILLNESS (Been really sick for 2 and half days), FEELING HOT (Really hot/felt like sun burned), BURNING SENSATION (Felt like sun burned), HYPERHIDROSIS (Start sweating), PAIN IN EXTREMITY (Arms hurting), MYALGIA (Body aches / severe body aches), HEADACHE (Headache), PYREXIA (Low grade temperature) and CHILLS (Chills / bad chills). On an unknown date, the patient experienced PSYCHOMOTOR HYPERACTIVITY (Hyperactive), SITTING DISABILITY (Could not sit still) and HUNGER (Was really hungry). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of 500 milligram, every 6 hrs. At the time of the report, PSYCHOMOTOR HYPERACTIVITY (Hyperactive), SITTING DISABILITY (Could not sit still), ASTHENIA (So weak / really weak), DECREASED APPETITE (Low appetite), FEELING COLD (Really cold with terrible chills then really hot and sweating), ILLNESS (Been really sick for 2 and half days), FEELING HOT (Really hot/felt like sun burned), BURNING SENSATION (Felt like sun burned), HUNGER (Was really hungry), HYPERHIDROSIS (Start sweating), PAIN IN EXTREMITY (Arms hurting), MYALGIA (Body aches / severe body aches), HEADACHE (Headache), PYREXIA (Low grade temperature) and CHILLS (Chills / bad chills) 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-2021-348139 (Patient Link).
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling hot, Headache, Hunger, Hyperhidrosis, Illness
Clinical narrative: Hyperactive; Could not sit still; Was really hungry; Start sweating; Arms hurting; Body aches / severe body aches; Headache; Low grade temperature; Chills / bad chills; So weak / really weak; Low appetite; Really cold with terrible chills then really hot and sweating; Been really sick for 2 and half days; Really hot/felt like sun burned; Felt like sun burned; This spontaneous case was reported by a consumer and describes the occurrence of PSYCHOMOTOR HYPERACTIVITY (Hyperactive), SITTING DISABILITY (Could not sit still), ASTHENIA (So weak / really weak), DECREASED APPETITE (Low appetite) and FEELING COLD (Really cold with terrible chills then really hot and sweating) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019F21A and 020F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included CLARITHROMYCIN (CLARITIN [CLARITHROMYCIN]), MULTIVITAMIN [VITAMINS NOS], VITAMIN C [ASCORBIC ACID], HYDROCHLOROTHIAZIDE, TELMISARTAN (TELMISARTAN/HCTZ) and AMLODIPINE for an unknown indication.   On 11-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Oct-2021, the patient experienced ASTHENIA (So weak / really weak), DECREASED APPETITE (Low appetite), FEELING COLD (Really cold with terrible chills then really hot and sweating), ILLNESS (Been really sick for 2 and half days), FEELING HOT (Really hot/felt like sun burned), BURNING SENSATION (Felt like sun burned), HYPERHIDROSIS (Start sweating), PAIN IN EXTREMITY (Arms hurting), MYALGIA (Body aches / severe body aches), HEADACHE (Headache), PYREXIA (Low grade temperature) and CHILLS (Chills / bad chills). On an unknown date, the patient experienced PSYCHOMOTOR HYPERACTIVITY (Hyperactive), SITTING DISABILITY (Could not sit still) and HUNGER (Was really hungry). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of 500 milligram, every 6 hrs. At the time of the report, PSYCHOMOTOR HYPERACTIVITY (Hyperactive), SITTING DISABILITY (Could not sit still), ASTHENIA (So weak / really weak), DECREASED APPETITE (Low appetite), FEELING COLD (Really cold with terrible chills then really hot and sweating), ILLNESS (Been really sick for 2 and half days), FEELING HOT (Really hot/felt like sun burned), BURNING SENSATION (Felt like sun burned), HUNGER (Was really hungry), HYPERHIDROSIS (Start sweating), PAIN IN EXTREMITY (Arms hurting), MYALGIA (Body aches / severe body aches), HEADACHE (Headache), PYREXIA (Low grade temperature) and CHILLS (Chills / bad chills) 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-2021-348139 (Patient Link).
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity, Psychomotor hyperactivity, Pyrexia, Sitting disability
Clinical narrative: Hyperactive; Could not sit still; Was really hungry; Start sweating; Arms hurting; Body aches / severe body aches; Headache; Low grade temperature; Chills / bad chills; So weak / really weak; Low appetite; Really cold with terrible chills then really hot and sweating; Been really sick for 2 and half days; Really hot/felt like sun burned; Felt like sun burned; This spontaneous case was reported by a consumer and describes the occurrence of PSYCHOMOTOR HYPERACTIVITY (Hyperactive), SITTING DISABILITY (Could not sit still), ASTHENIA (So weak / really weak), DECREASED APPETITE (Low appetite) and FEELING COLD (Really cold with terrible chills then really hot and sweating) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019F21A and 020F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included CLARITHROMYCIN (CLARITIN [CLARITHROMYCIN]), MULTIVITAMIN [VITAMINS NOS], VITAMIN C [ASCORBIC ACID], HYDROCHLOROTHIAZIDE, TELMISARTAN (TELMISARTAN/HCTZ) and AMLODIPINE for an unknown indication.   On 11-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Oct-2021, the patient experienced ASTHENIA (So weak / really weak), DECREASED APPETITE (Low appetite), FEELING COLD (Really cold with terrible chills then really hot and sweating), ILLNESS (Been really sick for 2 and half days), FEELING HOT (Really hot/felt like sun burned), BURNING SENSATION (Felt like sun burned), HYPERHIDROSIS (Start sweating), PAIN IN EXTREMITY (Arms hurting), MYALGIA (Body aches / severe body aches), HEADACHE (Headache), PYREXIA (Low grade temperature) and CHILLS (Chills / bad chills). On an unknown date, the patient experienced PSYCHOMOTOR HYPERACTIVITY (Hyperactive), SITTING DISABILITY (Could not sit still) and HUNGER (Was really hungry). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of 500 milligram, every 6 hrs. At the time of the report, PSYCHOMOTOR HYPERACTIVITY (Hyperactive), SITTING DISABILITY (Could not sit still), ASTHENIA (So weak / really weak), DECREASED APPETITE (Low appetite), FEELING COLD (Really cold with terrible chills then really hot and sweating), ILLNESS (Been really sick for 2 and half days), FEELING HOT (Really hot/felt like sun burned), BURNING SENSATION (Felt like sun burned), HUNGER (Was really hungry), HYPERHIDROSIS (Start sweating), PAIN IN EXTREMITY (Arms hurting), MYALGIA (Body aches / severe body aches), HEADACHE (Headache), PYREXIA (Low grade temperature) and CHILLS (Chills / bad chills) 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-2021-348139 (Patient Link).
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered expired vaccine; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine). On 10-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine) had resolved.            Concomitant medication use was unknown Treatment information was unknown   This case was linked to MOD-2021-347953 (Patient Link).
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Memory impairment, Mental disorder
Clinical narrative: mentally out of it for 5 days; did not recognize anyone; This spontaneous case was reported by a pharmacist and describes the occurrence of MENTAL DISORDER (mentally out of it for 5 days) and MEMORY IMPAIRMENT (did not recognize anyone) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Psychiatric disorder NOS (has been stabilized for 40 years). Concomitant products included CLOZAPINE, VALPROATE SEMISODIUM (DIVALPROEX), ZIPRASIDONE HYDROCHLORIDE (GEODON [ZIPRASIDONE HYDROCHLORIDE]), LAMOTRIGINE (LAMICTAL), BENZATROPINE MESILATE (COGENTIN), L-METHYLFOLATE, LEVOTHYROXINE, FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]), CROMOGLICATE SODIUM (NASALCROM), ALBUTEROL [SALBUTAMOL], CALCIUM, MULTIVITAMIN [VITAMINS NOS] and FISH OIL for an unknown indication.    In February 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MENTAL DISORDER (mentally out of it for 5 days) and MEMORY IMPAIRMENT (did not recognize anyone). At the time of the report, MENTAL DISORDER (mentally out of it for 5 days) and MEMORY IMPAIRMENT (did not recognize anyone) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient visited an orthopedic surgeon regarding an unspecified procedure and during the consultation she got up from the chair and started walking around like she did not recognize anyone. After 5 days she was back to normal like a switch was turned.   No treatment details were reported.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis, Sinusitis, Upper-airway cough syndrome, Vaccination site pain
Clinical narrative: Contracted a cold; Sinus infection; Sinus drainage  in throat; Tenderness around the shot area; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Contracted a cold), SINUSITIS (Sinus infection), UPPER-AIRWAY COUGH SYNDROME (Sinus drainage  in throat) and VACCINATION SITE PAIN (Tenderness around the shot area) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included FLUCONAZOLE for Yeast infection, METFORMIN and GABAPENTIN for an unknown indication.  On 20-Sep-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 NASOPHARYNGITIS (Contracted a cold), SINUSITIS (Sinus infection), UPPER-AIRWAY COUGH SYNDROME (Sinus drainage  in throat) and VACCINATION SITE PAIN (Tenderness around the shot area). The patient was treated with PARACETAMOL, PHENYLEPHRINE HYDROCHLORIDE (EQUATE SINUS DAY TIME) for Sinusitis, at an unspecified dose and frequency and DOXYLAMINE SUCCINATE, PARACETAMOL, PHENYLEPHRINE HYDROCHLORIDE (EQUATE SINUS NIGHT TIME) for Sinusitis, at an unspecified dose and frequency. At the time of the report, NASOPHARYNGITIS (Contracted a cold), SINUSITIS (Sinus infection), UPPER-AIRWAY COUGH SYNDROME (Sinus drainage  in throat) and VACCINATION SITE PAIN (Tenderness around the shot area) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   The patient was scheduled for her second dose on 18-Oct-2021.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 3 patients were given doses that expired on Saturday; 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 EXPIRED PRODUCT ADMINISTERED (3 patients were given doses that expired on Saturday) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (3 patients were given doses that expired on Saturday). On 11-Oct-2021, EXPIRED PRODUCT ADMINISTERED (3 patients were given doses that expired on Saturday) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant information was not provided. Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received the vaccine beyond the use date; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received the vaccine beyond the use date) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Jun-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received the vaccine beyond the use date). On 17-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Received the vaccine beyond the use date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Treatment information was unknown.  The reporter asked if the patients may need another vaccine booster.   This case was linked to MOD-2021-348962 (Patient Link).
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Oligomenorrhoea, Pain in extremity
Clinical narrative: Tender arm; Menstrual bleeding for 3 weeks; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Tender arm) and OLIGOMENORRHOEA (Menstrual bleeding for 3 weeks) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, the patient experienced PAIN IN EXTREMITY (Tender arm) and OLIGOMENORRHOEA (Menstrual bleeding for 3 weeks). In September 2021, OLIGOMENORRHOEA (Menstrual bleeding for 3 weeks) had resolved. At the time of the report, PAIN IN EXTREMITY (Tender arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant details was not provided.  No treatment information was provided.   This case was linked to MOD-2021-348591 (Patient Link).
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Did not get 2nd dose 1 month after the 1st dose; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Did not get 2nd dose 1 month after the 1st dose) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 11-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Did not get 2nd dose 1 month after the 1st dose). On 11-Oct-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Did not get 2nd dose 1 month after the 1st dose) 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 reported.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm sore) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included AMLODIPINE for Blood pressure, FLUTICASONE for Breathing difficult, OLODATEROL HYDROCHLORIDE, TIOTROPIUM BROMIDE MONOHYDRATE (STIOLTO RESPIMAT) for COPD, DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE (FARXIGA) and EMPAGLIFLOZIN (JARDIANCE) for Diabetes, PANCREATIN (CREON) for Pancreatic atrophy, GABAPENTIN, PRAVASTATIN, VENLAFAXINE, VALSARTAN and VITAMIN D [VITAMIN D NOS] for an unknown indication.    On 18-Feb-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 IN EXTREMITY (Arm sore). At the time of the report, PAIN IN EXTREMITY (Arm sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication was reported.   This case was linked to MOD-2021-348449 (Patient Link).
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Myocardial infarction, Product dose omission issue, SARS-CoV-2 test
Clinical narrative: she had a heart attack; She was not scheduled for the second dose and missed it/ Missed second dose > 5 months; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDIAL INFARCTION (she had a heart attack) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (She was not scheduled for the second dose and missed it/ Missed second dose > 5 months). On 22-May-2021, the patient experienced MYOCARDIAL INFARCTION (she had a heart attack) (seriousness criteria hospitalization and medically significant). The patient was hospitalized from 22-May-2021 to 25-May-2021 due to MYOCARDIAL INFARCTION. The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] for Anticoagulant therapy, at an unspecified dose and frequency; PRASUGREL for Anticoagulant therapy, at an unspecified dose and frequency and Surgery (2 stents had put in) for Myocardial infarction. On 20-Mar-2021, PRODUCT DOSE OMISSION ISSUE (She was not scheduled for the second dose and missed it/ Missed second dose > 5 months) had resolved. At the time of the report, MYOCARDIAL INFARCTION (she had a heart attack) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2020, SARS-CoV-2 test: negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. Patient reported that she had no history of heart problem.  Company comment: This is a case of Product dose omission of this 58-year-old, female patient, with no known medical history, who experienced the serious, unexpected, AESI event of Myocardial infarction. The event occurred  2 months after first dose of Moderna vaccine. The rechallenge is not applicable as patient only received first dose. The long onset latency of 2 months remain as confounder to the event. The benefit-risk relationship of Moderna vaccine is not affected by this report.   This case was linked to MOD-2021-349207, MOD-2021-006363 (Patient Link).; Sender's Comments: This is a case of Product dose omission of this 58-year-old, female patient, with no known medical history, who experienced the serious, unexpected, AESI event of Myocardial infarction. The event occurred  2 months after first dose of Moderna vaccine. The rechallenge is not applicable as patient only received first dose. The long onset latency of 2 months remain as confounder to the event. The benefit-risk relationship of Moderna vaccine is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Interchange of vaccine products, Underdose
Clinical narrative: My partner has had double Astra Zeneca, yesterday we both received a half dose booster of your Moderna.; Recieved half dose booster of Moderna; This spontaneous case was reported by a consumer and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (My partner has had double Astra Zeneca, yesterday we both received a half dose booster of your Moderna.) and UNDERDOSE (Recieved half dose booster of Moderna) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for an unreported indication: ASTRA ZENECA COMPOUND 677 (Patient had double Astra Zeneca).    On 10-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Oct-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (My partner has had double Astra Zeneca, yesterday we both received a half dose booster of your Moderna.) and UNDERDOSE (Recieved half dose booster of Moderna). On 10-Oct-2021, INTERCHANGE OF VACCINE PRODUCTS (My partner has had double Astra Zeneca, yesterday we both received a half dose booster of your Moderna.) and UNDERDOSE (Recieved half dose booster of Moderna) had resolved.            No concomitant medications were provided.  No treatment medications were provided.   This case was linked to MOD-2021-349089 (Patient Link).
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm pain; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 11-Oct-2021 and was forwarded to Moderna on 11-Oct-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm pain) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025C21A) for COVID-19 vaccination.     Concurrent medical conditions included Fibromyalgia, Neuropathy, Sciatica and Acid reflux (esophageal). Concomitant products included GABAPENTIN, VALACYCLOVIR [VALACICLOVIR] and OMEPRAZOLE (ZEGERID [OMEPRAZOLE]) for Acid reflux (esophageal), ALPRAZOLAM, PRAVASTATIN, METOPROLOL, NALTREXONE, ALPRAZOLAM (XANAX) and VORTIOXETINE HYDROBROMIDE (TRINTELLIX) for an unknown indication.    On 14-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2021, the patient experienced PAIN IN EXTREMITY (arm pain). In June 2021, PAIN IN EXTREMITY (arm pain) 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.   No treatment information was provided.   This case was linked to MOD-2021-349041 (Patient Link).
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Cough
Clinical narrative: Cough that "goes with the condition" / being tested for lung disease; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Cough that "goes with the condition" / being tested for lung disease) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 09762A and 025020A) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COUGH (Cough that "goes with the condition" / being tested for lung disease). At the time of the report, COUGH (Cough that "goes with the condition" / being tested for lung disease) outcome was unknown.            Patient was being tested for lung disease. No concomitant products were reported. No treatment information was provided.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: slight pain in left injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (slight pain in left injection site arm) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-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 VACCINATION SITE PAIN (slight pain in left injection site arm). At the time of the report, VACCINATION SITE PAIN (slight pain in left injection site arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication details were not provided. Treatment details were not provided. The patient reports no Adverse Reactions after his second Moderna Covid-19 vaccine.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Severe reaction to vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Severe reaction to vaccine) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced VACCINATION COMPLICATION (Severe reaction to vaccine). At the time of the report, VACCINATION COMPLICATION (Severe reaction to vaccine) 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.   This case was linked to MOD-2021-348714 (Patient Link).
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Allergy to vaccine, Pruritus, Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Warm to the touch Injection Site after 3rd shot; Itching from Head to toe after 3rd shot; Histamine reaction after 3rd shot; Swollen Injection Site for 3-4 days after 3rd shot; Itchy Injection Site after 3rd shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Warm to the touch Injection Site after 3rd shot), PRURITUS (Itching from Head to toe after 3rd shot), ALLERGY TO VACCINE (Histamine reaction after 3rd shot), VACCINATION SITE SWELLING (Swollen Injection Site for 3-4 days after 3rd shot) and VACCINATION SITE PRURITUS (Itchy Injection Site after 3rd shot) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Sulfonamide allergy (Caller stated allergic to sulfa.).  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 VACCINATION SITE WARMTH (Warm to the touch Injection Site after 3rd shot), PRURITUS (Itching from Head to toe after 3rd shot), ALLERGY TO VACCINE (Histamine reaction after 3rd shot), VACCINATION SITE SWELLING (Swollen Injection Site for 3-4 days after 3rd shot) and VACCINATION SITE PRURITUS (Itchy Injection Site after 3rd shot). At the time of the report, VACCINATION SITE WARMTH (Warm to the touch Injection Site after 3rd shot), PRURITUS (Itching from Head to toe after 3rd shot), ALLERGY TO VACCINE (Histamine reaction after 3rd shot), VACCINATION SITE SWELLING (Swollen Injection Site for 3-4 days after 3rd shot) and VACCINATION SITE PRURITUS (Itchy Injection Site after 3rd shot) outcome was unknown.      No concomitant medications were reported.  No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Have been keeping track of my body and symptoms/Is there someone I can send some details to?; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Have been keeping track of my body and symptoms/Is there someone I can send some details to?) 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 VACCINATION COMPLICATION (Have been keeping track of my body and symptoms/Is there someone I can send some details to?). At the time of the report, VACCINATION COMPLICATION (Have been keeping track of my body and symptoms/Is there someone I can send some details to?) outcome was unknown.            No concomitant medications reported. No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 2 patients received expired moderna covid-19 vaccine/Expired vaccine used; 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 EXPIRED PRODUCT ADMINISTERED (2 patients received expired moderna covid-19 vaccine/Expired vaccine used) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (2 patients received expired moderna covid-19 vaccine/Expired vaccine used). On 14-Oct-2021, EXPIRED PRODUCT ADMINISTERED (2 patients received expired moderna covid-19 vaccine/Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported. Treatment medications was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 15-Oct-2021: follow-up document Includes no new information
Sex: F
Vaccine: COVID19
Symptoms: Migraine
Clinical narrative: missed her 2nd dose due to migraine; This is a spontaneous case received from a contactable female consumer. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; formulation: Solution for injection, Lot Number: UNKNOWN), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. The patient medical history included migraine from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. It was reported that she missed her second dose due to migraine, she wants to reschedule her second dose. She mentioned that her migraine was not related to vaccine. She already have this and it is on and off. The patient experienced missed her 2nd dose due to migraine and missed her 2nd dose due to migraine those from on an unspecified date. The clinical outcome of the events was unknown.  Follow up (15Mar2021): This is a Non Significant Follow-up spontaneous report received from a contactable consumer. No new information in source.  Follow-up (14May2021): Follow-up attempts completed. No further information expected.  Follow-up attempts completed. No further information expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Injection site pain
Clinical narrative: I experienced mild symptoms such as soreness at injection site, slight headache and fatigue about 3 hours after receiving injection. I think these may be normal reactions to the vaccine. I took Tylenol to ease symptoms.  I was advised by my manager  to report anyway.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Eczema nummular, Pruritus, Rash
Clinical narrative: developed itchy nummular eczema like rash across body and extremities.
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood glucose, Bundle branch block right, Cardiac pacemaker insertion, Echocardiogram, Electrocardiogram
Clinical narrative: Mid-May (one month after 2nd dose), experienced racing heart (suspected tachycardia) while walking (for fitness), above 130bpm. 9/1/2021 -- experienced first near-syncope around 5pm while standing; resolved itself after several minutes. 9/16/2021 -- experienced second near-syncope around 9:30am while sitting at desk; went to Emergency Center at Hospital. EKG performed, no treatment. No further events. 9/25/2021 -- experienced third near-syncope around 7:30am, while standing (and collapsed to floor this time). Opted not to head to EC at hospital again, at the time. 9/25/2021 -- experienced fourth and fifth near-syncopes around 2pm, while seated. Opted to head to EC at hospital, had sixth near-syncope while riding to EC. Kept in EC while waiting to be admitted to hospital. 9/26/2021 -- diagnosed with right bundle branch block. 9/29/2021 -- cardiac pacemaker implanted (hospital, MD)
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Laboratory test, Palpitations, Presyncope, Syncope, Tachycardia
Clinical narrative: Mid-May (one month after 2nd dose), experienced racing heart (suspected tachycardia) while walking (for fitness), above 130bpm. 9/1/2021 -- experienced first near-syncope around 5pm while standing; resolved itself after several minutes. 9/16/2021 -- experienced second near-syncope around 9:30am while sitting at desk; went to Emergency Center at Hospital. EKG performed, no treatment. No further events. 9/25/2021 -- experienced third near-syncope around 7:30am, while standing (and collapsed to floor this time). Opted not to head to EC at hospital again, at the time. 9/25/2021 -- experienced fourth and fifth near-syncopes around 2pm, while seated. Opted to head to EC at hospital, had sixth near-syncope while riding to EC. Kept in EC while waiting to be admitted to hospital. 9/26/2021 -- diagnosed with right bundle branch block. 9/29/2021 -- cardiac pacemaker implanted (hospital, MD)
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Vomiting, Weight, Weight decreased
Clinical narrative: throwing up/vomiting; stomach is killing me; I've lost 10lbs; This is a spontaneous report from a non-contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 25Mar2021 as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. The patient stated that I had some sort of reaction and can't figure out why I've been throwing up. I received the second dose last Thursday 25Mar2021 and vomiting started since then. I don't mind that I've lost 10lbs, but my stomach is killing me. Patient asked does the vaccine contain capsaicin and what can I take for the vomiting. The patient underwent lab tests and procedures which included weight: lost 10lbs on unknown date in 2021 (I've lost 10lbs). Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: itching/Persistent itch on head, scalp, back of neck and upper shoulder; This is a spontaneous report from a contactable consumer (patient). An 83-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number EP7534 and expiry date not reported), via intramuscular, administered in Deltoid Left (reported as left shoulder in the muscle), on 19Mar2021 11:00 (at the age of 83-year-old), as dose 2, single, for COVID-19 immunisation. Medical history included high blood pressure. The patient was on two high blood pressure medications. It was reported that, over the course of time, she has shrunk. It was prior to the vaccine and stated most people lose height as they age. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number EN6198 and expiry date not reported), via intramuscular, administered in Deltoid Left (reported as left shoulder in the muscle), on 26Feb2021 (at the age of 83-year-old), as dose 1, single, for COVID-19 immunisation and experienced no side effects. No additional vaccines administered on same date of the Pfizer suspect. After second COVID shot, two or three day after the injection (Mar2021), the patient started itching. It was a persistent itch to her head, scalp, back of neck and upper shoulder. It was fairly constant. The patient wanted to know if it was a result of vaccine. She has had her head examined and there was no evidence of flakes or bugs. The patient asked how long the symptoms last. The outcome of the event was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Hypersensitivity, Rash, Rash erythematous, Vaccination site rash
Clinical narrative: rash almost all the body except for the bottom part of the leg; rash and it wasn't just in the injection site; feels warm to the touch; all over her arms, trunk, torso area and also on her thighs, it was like bumps that turned into like a sunburn almost; allergic reaction; This is a spontaneous report from a contactable consumer (patient) from a Pfizer sponsored program. A 28-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: ER8732 and expiration date: 31Jul2021), via an unspecified route of administration, administered in Arm Left bicep on 24Mar2021 18:45 (at the age of 28-year-old), as dose 1, single, for COVID-19 immunisation. The patient medical history was not reported. There were no concomitant medications. The patient previously took ceclor and had a reaction to drug. No additional vaccines administered on same date of the Pfizer suspect. No prior vaccinations within 4 weeks. The patient started experiencing an adverse reaction on 29Mar2021. The patient developed a rash, and it wasn't just in the injection site, almost all the body except for the bottom part of the leg that was considered normal or severe. It was kind of all over her arms, trunk, torso area and also on her thighs but it was like bumps that turned into like a sunburn almost. It was reported that, it had cleared up now and was like a sunburn like it had just changed the color of skin to just reddish and feels warm to touch. At the time of report, it was clearing up and she confirms it was ongoing but improved, it had improved a lot as it was almost gone. The patient wanted to know if she should get second dose of the vaccine after experiencing the rash. The patient went to emergency room due to the events. No relevant tests were done. The outcome of the events was recovering.  No follow-up attempts are needed. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Diarrhoea, Dysgeusia, Fatigue, Laboratory test
Clinical narrative: GI system is still little bit sensitive; diarrhea; had 6 hives near the injection site that were not itchy or large for hives she has had in the past; extreme tiredness/getting very very tired; could not keep eye open past 19:30 to 20:00/literally falling asleep while doing things; metallic taste in mouth; Terrible Nightmares; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. A 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EP7533 and expiration date: Jul2021), via an unspecified route of administration on 29Mar2021 at 13:30 (at the age of 53-year-old), dose 1, single for COVID-19 immunisation. Medical history included asthma, allergy to animals, hives, and calcium deficit disorder. Concomitant medications included salbutamol (ALBUTEROL) over 20 years; amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) for one and a half year; fluticasone propionate (FLOVENT) for at least 5 years not 10 or more and Amphet/Dextr (as reported). The patient stated around 19:30, she had 6 hives near the injection site that were not itchy or large for hives she has had in the past. The patient stated she had extreme tiredness and could not keep her eyes open. The patient stated she had a metallic taste in her mouth that lasted several days. The patient also had diarrhea. The patient stated she has a history of asthma and would like to know if this would affect the reasoning for receiving the second dose and if others who received the vaccine had a history of asthma. The patient stated about 05:00, she was getting very tired, may be even earlier and she went off to bed and she was giving herself a message and she had terrible nightmares that night. The patient could not keep her eye open past 19:30 to 20:00, she was literally falling asleep while she was doing things.  In addition to that she had six hives near the injection site. The patient had a metallic taste in her mouth which she still has and had diarrhea the next day and her gastrointestinal system was still little bit sensitive. The patient stated none of the reactions require any medical attention, but her doctors has suggested that she should get in touch with Pfizer directly, because she given reactions, she thinks she should not get the second dose of the vaccine.  The patient called her doctor on the day of report. The patient had lab work done on 18Mar2021, the usual stuff for annual physical, cholesterol (as reported) which showed nothing unusual, everything was in normal range. The events were reported as non-serious. The outcome of the events metallic taste in mouth was not recovered and outcome of other events was unknown.  No follow-up attempts are possible; No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Nightmare, Somnolence, Urticaria
Clinical narrative: GI system is still little bit sensitive; diarrhea; had 6 hives near the injection site that were not itchy or large for hives she has had in the past; extreme tiredness/getting very very tired; could not keep eye open past 19:30 to 20:00/literally falling asleep while doing things; metallic taste in mouth; Terrible Nightmares; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. A 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EP7533 and expiration date: Jul2021), via an unspecified route of administration on 29Mar2021 at 13:30 (at the age of 53-year-old), dose 1, single for COVID-19 immunisation. Medical history included asthma, allergy to animals, hives, and calcium deficit disorder. Concomitant medications included salbutamol (ALBUTEROL) over 20 years; amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) for one and a half year; fluticasone propionate (FLOVENT) for at least 5 years not 10 or more and Amphet/Dextr (as reported). The patient stated around 19:30, she had 6 hives near the injection site that were not itchy or large for hives she has had in the past. The patient stated she had extreme tiredness and could not keep her eyes open. The patient stated she had a metallic taste in her mouth that lasted several days. The patient also had diarrhea. The patient stated she has a history of asthma and would like to know if this would affect the reasoning for receiving the second dose and if others who received the vaccine had a history of asthma. The patient stated about 05:00, she was getting very tired, may be even earlier and she went off to bed and she was giving herself a message and she had terrible nightmares that night. The patient could not keep her eye open past 19:30 to 20:00, she was literally falling asleep while she was doing things.  In addition to that she had six hives near the injection site. The patient had a metallic taste in her mouth which she still has and had diarrhea the next day and her gastrointestinal system was still little bit sensitive. The patient stated none of the reactions require any medical attention, but her doctors has suggested that she should get in touch with Pfizer directly, because she given reactions, she thinks she should not get the second dose of the vaccine.  The patient called her doctor on the day of report. The patient had lab work done on 18Mar2021, the usual stuff for annual physical, cholesterol (as reported) which showed nothing unusual, everything was in normal range. The events were reported as non-serious. The outcome of the events metallic taste in mouth was not recovered and outcome of other events was unknown.  No follow-up attempts are possible; No further information is expected.