chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site discharge
Clinical narrative: good sized drop / running down my wife's shoulder when she got her shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCHARGE (good sized drop / running down my wife's shoulder when she got her shot) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028D21A, 031MZ0H and 003A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE DISCHARGE (good sized drop / running down my wife's shoulder when she got her shot). At the time of the report, VACCINATION SITE DISCHARGE (good sized drop / running down my wife's shoulder when she got her shot) outcome was unknown.            No Concomitant medications were provided by the reporter. No Treatment information was reported.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: patient was administered an expired booster dose; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient was administered an expired booster dose) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient was administered an expired booster dose). On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (patient was administered an expired booster dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter. Treatment information was not provided by the reporter.   This case was linked to MOD-2021-369020 (Patient Link).
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Nasopharyngitis, Product dose omission issue
Clinical narrative: Bad cold/really bad cold on his chest; 37 days since first dose, has not received 2nd yet; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Bad cold/really bad cold on his chest) and PRODUCT DOSE OMISSION ISSUE (37 days since first dose, has not received 2nd yet) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 088d21a) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes, Cancer and Heart disorder.    On 22-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Sep-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (37 days since first dose, has not received 2nd yet). In October 2021, the patient experienced NASOPHARYNGITIS (Bad cold/really bad cold on his chest). On 22-Sep-2021, PRODUCT DOSE OMISSION ISSUE (37 days since first dose, has not received 2nd yet) had resolved. At the time of the report, NASOPHARYNGITIS (Bad cold/really bad cold on his chest) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient had medicine for his heart as a concomitant.  Patient took cough medicine & antibiotics for treatment.  Patient had experienced the bad cold event just before 25th and which he still had for almost 3 weeks.   Most recent FOLLOW-UP information incorporated above includes: On 01-Nov-2021: Added batch number, concomitant and treatment information and event information.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was administered an expired booster dose; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered an expired booster dose) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered an expired booster dose). On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Patient was administered an expired booster dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medicines were reported No treatment medicines were reported   This case was linked to MOD-2021-369020 (Patient Link).
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: The patient received a dose from a vial more than 30 days on the fridge; The patient received a dose from a vial more than 30 days on the fridge; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The patient received a dose from a vial more than 30 days on the fridge) and PRODUCT STORAGE ERROR (The patient received a dose from a vial more than 30 days on the fridge) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (The patient received a dose from a vial more than 30 days on the fridge) and PRODUCT STORAGE ERROR (The patient received a dose from a vial more than 30 days on the fridge). On 21-Jul-2021, EXPIRED PRODUCT ADMINISTERED (The patient received a dose from a vial more than 30 days on the fridge) and PRODUCT STORAGE ERROR (The patient received a dose from a vial more than 30 days on the fridge) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drugs were reported.  Reporter stated that on 20th April 2021 the vial was initially stored in the refrigerator and moved the vaccine into the fridge.Reporter confirmed that none of the patients experienced any side effects.  No treatment drugs were reported.   Most recent FOLLOW-UP information incorporated above includes: On 02-Nov-2021: Follow-up received contains added reporter fax and HCP confirmed that none of the patients experienced side effects.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose, Product storage error
Clinical narrative: Full dose instead of a half dose; Five doses (lot # 017C21A) of the Moderna Covid-19 Vaccine were given to patients today; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL OVERDOSE (Full dose instead of a half dose) and PRODUCT STORAGE ERROR (Five doses (lot # 017C21A) of the Moderna Covid-19 Vaccine were given to patients today) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017C21A, 011M20A and 037K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, the patient experienced ACCIDENTAL OVERDOSE (Full dose instead of a half dose) and PRODUCT STORAGE ERROR (Five doses (lot # 017C21A) of the Moderna Covid-19 Vaccine were given to patients today). On 29-Oct-2021, ACCIDENTAL OVERDOSE (Full dose instead of a half dose) and PRODUCT STORAGE ERROR (Five doses (lot # 017C21A) of the Moderna Covid-19 Vaccine were given to patients today) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant treatment was reported.  No treatment medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 29-Oct-2021: Added updated fax number and added event information, narrative was generated accordingly.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: The patient received a dose from a vial more than 30 days on the fridge; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The patient received a dose from a vial more than 30 days on the fridge) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014C21A and 014C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Jun-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (The patient received a dose from a vial more than 30 days on the fridge). On 16-Jun-2021, EXPIRED PRODUCT ADMINISTERED (The patient received a dose from a vial more than 30 days on the fridge) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 02-Nov-2021: Significant Follow up- HCP confirmed number of patients
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Blepharospasm, Pruritus, Pyrexia
Clinical narrative: left eye was twitching,; her right leg was itching; had a fever, that is still going down,; This spontaneous case was reported by a consumer and describes the occurrence of BLEPHAROSPASM (left eye was twitching,), PRURITUS (her right leg was itching) and PYREXIA (had a fever, that is still going down,) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939905) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Oct-2021, the patient experienced BLEPHAROSPASM (left eye was twitching,), PRURITUS (her right leg was itching) and PYREXIA (had a fever, that is still going down,). On 31-Oct-2021, BLEPHAROSPASM (left eye was twitching,) and PRURITUS (her right leg was itching) outcome was unknown. At the time of the report, PYREXIA (had a fever, that is still going down,) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant and treatment medications were provided  Patient reported that she had miss a day of work.    This case was linked to MOD-2021-368985 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Lethargy, Muscle spasms
Clinical narrative: feeling very lethargic; has muscle cramps.; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (feeling very lethargic) and MUSCLE SPASMS (has muscle cramps.) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 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 LETHARGY (feeling very lethargic) and MUSCLE SPASMS (has muscle cramps.). At the time of the report, LETHARGY (feeling very lethargic) and MUSCLE SPASMS (has muscle cramps.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Blood pressure measurement, Chills, Cold sweat, Diarrhoea
Clinical narrative: sick; pretty significant abdominal cramping; diaphoretic; clammy; diarrhea; chills; nausea; vomiting; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick), ABDOMINAL PAIN (pretty significant abdominal cramping), HYPERHIDROSIS (diaphoretic), COLD SWEAT (clammy) and DIARRHOEA (diarrhea) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (sick), ABDOMINAL PAIN (pretty significant abdominal cramping), HYPERHIDROSIS (diaphoretic), COLD SWEAT (clammy), DIARRHOEA (diarrhea), CHILLS (chills), NAUSEA (nausea) and VOMITING (vomiting). At the time of the report, ILLNESS (sick), ABDOMINAL PAIN (pretty significant abdominal cramping), HYPERHIDROSIS (diaphoretic), COLD SWEAT (clammy), DIARRHOEA (diarrhea), CHILLS (chills), NAUSEA (nausea) and VOMITING (vomiting) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: normal (normal) normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.  Patient had no temperature and blood pressure was fine.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Illness, Nausea, Vomiting
Clinical narrative: sick; pretty significant abdominal cramping; diaphoretic; clammy; diarrhea; chills; nausea; vomiting; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick), ABDOMINAL PAIN (pretty significant abdominal cramping), HYPERHIDROSIS (diaphoretic), COLD SWEAT (clammy) and DIARRHOEA (diarrhea) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (sick), ABDOMINAL PAIN (pretty significant abdominal cramping), HYPERHIDROSIS (diaphoretic), COLD SWEAT (clammy), DIARRHOEA (diarrhea), CHILLS (chills), NAUSEA (nausea) and VOMITING (vomiting). At the time of the report, ILLNESS (sick), ABDOMINAL PAIN (pretty significant abdominal cramping), HYPERHIDROSIS (diaphoretic), COLD SWEAT (clammy), DIARRHOEA (diarrhea), CHILLS (chills), NAUSEA (nausea) and VOMITING (vomiting) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: normal (normal) normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.  Patient had no temperature and blood pressure was fine.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Dry mouth, Pruritus, Somnolence, Vaccination site pain
Clinical narrative: has a dry mouth; been itching all over her body,still itching from the top of her head to the bottom of her foot; her right dominant  arm is hurting after receiving the dose of the vaccine in that arm; Sleepy; This spontaneous case was reported by a consumer and describes the occurrence of DRY MOUTH (has a dry mouth), SOMNOLENCE (Sleepy), PRURITUS (been itching all over her body,still itching from the top of her head to the bottom of her foot) and VACCINATION SITE PAIN (her right dominant  arm is hurting after receiving the dose of the vaccine in that arm) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076c21a) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (opioids like pain medications), Drug allergy (morphine), Drug allergy (codeine), Drug allergy (sulfur), Drug allergy (steroid), Drug allergy (Demerol), Drug allergy (Lortabs) and Drug allergy (promedol.). Concomitant products included METOPROLOL, LEVOTHYROXINE, CLONAZEPAM and VITAMIN D3 for an unknown indication.    On 30-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In October 2021, the patient experienced SOMNOLENCE (Sleepy). On 30-Oct-2021, the patient experienced DRY MOUTH (has a dry mouth), PRURITUS (been itching all over her body,still itching from the top of her head to the bottom of her foot) and VACCINATION SITE PAIN (her right dominant  arm is hurting after receiving the dose of the vaccine in that arm). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, DRY MOUTH (has a dry mouth), SOMNOLENCE (Sleepy) and VACCINATION SITE PAIN (her right dominant  arm is hurting after receiving the dose of the vaccine in that arm) outcome was unknown and PRURITUS (been itching all over her body,still itching from the top of her head to the bottom of her foot) had not 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.   Patient had taken three caps of Benadryl and has  went to ER and got a benadryl shot. Patient stated that the medication made sleepy and was still itching from the top of head to the bottom of the foot.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: patient was administered an expired booster dose; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient was administered an expired booster dose) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 3 dosage form. On 29-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient was administered an expired booster dose). On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (patient was administered an expired booster dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were provided.   This case was linked to MOD-2021-369020, MOD-2021-368822, MOD-2021-368863, MOD-2021-368935, MOD-2021-369043, MOD-2021-368886, MOD-2021-369053, MOD-2021-369371, MOD-2021-368831, MOD-2021-369347, MOD-2021-369022, MOD-2021-369249, MOD-2021-369376, MOD-2021-369056, MOD-2021-369020 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Feeling abnormal, SARS-CoV-2 antibody test
Clinical narrative: he's a little bit foggy; Vaccine breakthrough infection and COVID-19; Lack of drug effect; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Vaccine breakthrough infection and COVID-19), DRUG INEFFECTIVE (Lack of drug effect) and FEELING ABNORMAL (he's a little bit foggy) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016B21A and 025A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, the patient experienced COVID-19 (Vaccine breakthrough infection and COVID-19) and DRUG INEFFECTIVE (Lack of drug effect). On an unknown date, the patient experienced FEELING ABNORMAL (he's a little bit foggy). At the time of the report, COVID-19 (Vaccine breakthrough infection and COVID-19), DRUG INEFFECTIVE (Lack of drug effect) and FEELING ABNORMAL (he's a little bit foggy) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Oct-2021, SARS-CoV-2 antibody test: positive (Positive) positive. On 29-Oct-2021, SARS-CoV-2 antibody test: positive (Positive) still positive.         No treatment and concomitant medications were reported.  He tested positive on the antigen home test on 25 Oct 2021. The patient had repeat testing on 29 Oct 2021 using the same kind of test still revealed positive result.   Most recent FOLLOW-UP information incorporated above includes: On 01-Nov-2021: Follow-up received on 01-NOV-2021 includes events added and lab data and other event related info.; Sender's Comments: This case concerns a 60-year-old male patient with no details on relevant medical history, who experienced the unexpected non serious event/ of COVID-19 after mRNA- 1273 Moderna vaccine (Moderna COVID-19 Vaccine / Spikevax). Additionally, Drug ineffective was captured. The event occurred approximately 7 months and 22 days after the second dose of mRNA- 1273 vaccine. The rechallenge was not applicable due to the nature of the event. The benefit-risk relationship of mRNA- 1273 vaccine / Moderna COVID-19 Vaccine is not affected by this report
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: injection site pain; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (injection site pain) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID], CARVEDILOL, ATORVASTATIN CALCIUM, LISINOPRIL and AMLODIPINE for an unknown indication.    On 28-Jan-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 INJECTION SITE PAIN (injection site pain). At the time of the report, INJECTION SITE PAIN (injection site pain) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   treatment to the events not reported.   This case was linked to MOD-2021-369033 (Patient Link).
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Chills, Fatigue, Headache, Injection site pain
Clinical narrative: injection site pain; chest pain; chills; a little fatigue; a slight headache; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (chest pain), CHILLS (chills), FATIGUE (a little fatigue), HEADACHE (a slight headache) and INJECTION SITE PAIN (injection site pain) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012F21A, 026L20A and 013L20A) for COVID-19 vaccination.     Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID], CARVEDILOL, ATORVASTATIN CALCIUM, LISINOPRIL and AMLODIPINE for an unknown indication.   On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, the patient experienced CHILLS (chills), FATIGUE (a little fatigue) and HEADACHE (a slight headache). On 30-Oct-2021, the patient experienced CHEST PAIN (chest pain). On an unknown date, the patient experienced INJECTION SITE PAIN (injection site pain). On 30-Oct-2021, CHEST PAIN (chest pain) had resolved. At the time of the report, CHILLS (chills), FATIGUE (a little fatigue), HEADACHE (a slight headache) and INJECTION SITE PAIN (injection site pain) outcome was unknown.            Treatment details not provided.   This case was linked to MOD-2021-369033, MOD-2021-369048 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: bells palsy; This spontaneous case was reported by a consumer and describes the occurrence of BELL'S PALSY (bells palsy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Oct-2021, the patient experienced BELL'S PALSY (bells palsy) (seriousness criterion medically significant). At the time of the report, BELL'S PALSY (bells palsy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication use was unknown.  On 29-Oct-2021, the patient went to emergency room  because the right side of her face was paralyzed and she was having slurred speech and they diagnosed her with bells palsy.  Treatment information was unknown.  Company Comment: This case concerns a female patient of an unknown age with no reported medical history who experienced expected event of Bell's palsy.  The event occurred 1 month 21 days after an unspecified dose of the mRNA-1273 (Moderna COVID-19 Vaccine). The rechallenge was unknown as the recent administered dose prior to the event was not specified.  Causality for the reported event was not provided by the reporter. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report. The event is an important medical event and an adverse event of special interest.; Sender's Comments: This case concerns a female patient of an unknown age with no reported medical history who experienced expected event of Bell's palsy.  The event occurred 1 mont 21 days after an unspecified dose of the mRNA-1273 (Moderna COVID-19 Vaccine). The rechallenge was unknown as the recent administered dose prior to the event was not specified.  Causality for the reported event was not provided by the reporter. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report. The event is an important medical event and an adverse event of special interest.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Expired product administered, Pyrexia
Clinical narrative: fever; chills; received expired dose of the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received expired dose of the vaccine), PYREXIA (fever) and CHILLS (chills) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     Concurrent medical conditions included Autoimmune disorder. Concomitant products included PARACETAMOL (TYLENOL [PARACETAMOL]) for an unknown indication.    On 20-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received expired dose of the vaccine). On 21-Oct-2021, the patient experienced PYREXIA (fever) and CHILLS (chills). On 20-Oct-2021, EXPIRED PRODUCT ADMINISTERED (received expired dose of the vaccine) had resolved. At the time of the report, PYREXIA (fever) and CHILLS (chills) outcome was unknown.            Lyrical  is also used as concomitant for unknown indication   He was on medications for autoimmune disorder Treatment information was unknown
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: They administrated the Moderna booster shot to 2 patients, Vial was moved from Freezer to fridge on 10Sep2021 and were used yesterday 30Oct2021, More than 30 days in the fridge; Vial was moved from Freezer to fridge on 10Sep2021 and were used yesterday; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (They administrated the Moderna booster shot to 2 patients, Vial was moved from Freezer to fridge on 10Sep2021 and were used yesterday 30Oct2021, More than 30 days in the fridge) and PRODUCT STORAGE ERROR (Vial was moved from Freezer to fridge on 10Sep2021 and were used yesterday) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017C21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy (codeine) and Allergy (Anaphylaxis to Iodine).   On 28-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (They administrated the Moderna booster shot to 2 patients, Vial was moved from Freezer to fridge on 10Sep2021 and were used yesterday 30Oct2021, More than 30 days in the fridge) and PRODUCT STORAGE ERROR (Vial was moved from Freezer to fridge on 10Sep2021 and were used yesterday). On 30-Oct-2021, EXPIRED PRODUCT ADMINISTERED (They administrated the Moderna booster shot to 2 patients, Vial was moved from Freezer to fridge on 10Sep2021 and were used yesterday 30Oct2021, More than 30 days in the fridge) and PRODUCT STORAGE ERROR (Vial was moved from Freezer to fridge on 10Sep2021 and were used yesterday) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 02-Nov-2021: follow up added Allergies On 02-Nov-2021: Follow up  contain no new information
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: their arm is red and a little swollen at the injection site; it has been sore; their arm is red and a little swollen at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (their arm is red and a little swollen at the injection site), VACCINATION SITE PAIN (it has been sore) and VACCINATION SITE SWELLING (their arm is red and a little swollen at the injection site) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In October 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient 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. In October 2021, the patient experienced VACCINATION SITE ERYTHEMA (their arm is red and a little swollen at the injection site), VACCINATION SITE PAIN (it has been sore) and VACCINATION SITE SWELLING (their arm is red and a little swollen at the injection site). At the time of the report, VACCINATION SITE ERYTHEMA (their arm is red and a little swollen at the injection site), VACCINATION SITE PAIN (it has been sore) and VACCINATION SITE SWELLING (their arm is red and a little swollen at the injection site) outcome was unknown.            patient reports that they got their Booster shot on Wednesday and that their arm is red and a little swollen at the injection site and that it has been sore, and that didn't happened with the first two doses of the Moderna covid19 vaccine. Also they notice redness the day that is calling Moderna.   No concomitant drug was reported.  No treatment drug was reported.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fear, Gait disturbance, Gait inability, Headache
Clinical narrative: Legs wouldn't work; Could not walk normal, but shuffled; light headed; Legs wouldn't work; Light headache; I was beginning to tramp my foot; This Adverse event this adverse effect is scary as hell; This spontaneous case was reported by a consumer and describes the occurrence of the second episode of GAIT INABILITY (Legs wouldn't work), GAIT DISTURBANCE (Could not walk normal, but shuffled), GAIT DISTURBANCE (I was beginning to tramp my foot), FEAR (This Adverse event this adverse effect is scary as hell) and DIZZINESS (light headed) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In October 2021, the patient experienced GAIT DISTURBANCE (I was beginning to tramp my foot), FEAR (This Adverse event this adverse effect is scary as hell) and HEADACHE (Light headache). October 2021, the patient experienced the first episode of GAIT INABILITY (Legs wouldn't work). On 30-Oct-2021, the patient experienced the second episode of GAIT INABILITY (Legs wouldn't work) and GAIT DISTURBANCE (Could not walk normal, but shuffled). 30-Oct-2021, the patient experienced DIZZINESS (light headed). At the time of the report, last episode of GAIT INABILITY (Legs wouldn't work), GAIT DISTURBANCE (Could not walk normal, but shuffled), GAIT DISTURBANCE (I was beginning to tramp my foot), FEAR (This Adverse event this adverse effect is scary as hell), DIZZINESS (light headed) and HEADACHE (Light headache) outcome was unknown.            Concomitant information was not provided.  Treatment information was reported as Stayed in Bed   This case was linked to MOD-2021-369536 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 02-Nov-2021: Significant Follow Up added on -event added and contact info, patient details updated, initials changed.
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Rhinorrhoea
Clinical narrative: having diarrhea ever since; a runny nose; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (having diarrhea ever since) and RHINORRHOEA (a runny nose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 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 DIARRHOEA (having diarrhea ever since) and RHINORRHOEA (a runny nose). At the time of the report, DIARRHOEA (having diarrhea ever since) and RHINORRHOEA (a runny nose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medications were reported.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Administration error, more than 30 days in the fridge; Administration error, more than 30 days in the fridge; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration error, more than 30 days in the fridge) and PRODUCT STORAGE ERROR (Administration error, more than 30 days in the fridge) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017C21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: JJ vacine (JJ vacine) on 16-Mar-2021. Past adverse reactions to the above products included No adverse event with JJ vacine.    On 30-Oct-2021 at 1:25 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration error, more than 30 days in the fridge) and PRODUCT STORAGE ERROR (Administration error, more than 30 days in the fridge). On 30-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Administration error, more than 30 days in the fridge) and PRODUCT STORAGE ERROR (Administration error, more than 30 days in the fridge) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided.  Treatment information was not provided.  Patient did not experience any adverse reactions during there 15 minute observation  Date the vial was initially stored in the refrigerator on 10-Sep-2021.   Most recent FOLLOW-UP information incorporated above includes: On 02-Nov-2021: follow up added reporter information, added ethnic group and vaccination given time. On 02-Nov-2021: Follow Up received contain
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was administered an expired booster dose; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered an expired booster dose) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered an expired booster dose). On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Patient was administered an expired booster dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant and medications were reported. On 16-Oct2021, the vial was initially stored in the refrigerator. The vial did not undergo any temperature excursions Unfortunately 16 doses were given on 29Oct2021 in the pharmacy. It was possible that more people got doses from vials with this lot number in another pharmacy of the same chain. But HCP did not have information on that.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: The patient received a dose from a vial more than 30 days on the fridge; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The patient received a dose from a vial more than 30 days on the fridge) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (The patient received a dose from a vial more than 30 days on the fridge). On 16-Jun-2021, EXPIRED PRODUCT ADMINISTERED (The patient received a dose from a vial more than 30 days on the fridge) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported. The vial was initially stored in the refrigerator on 20 Apr 2021. The vial did not undergo any temperature excursions.HCP mentioned that there were 14 patients instead of 18 because of some duplicates.   This case was linked to MOD-2021-369020, MOD-2021-369330 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 02-Nov-2021: HCP confirmed number of patients
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Balance disorder, Headache, Vision blurred, Visual impairment
Clinical narrative: Visual Impairment; Blurry vision; Balance difficulty; Headache; This spontaneous case was reported by a consumer and describes the occurrence of VISUAL IMPAIRMENT (Visual Impairment), VISION BLURRED (Blurry vision), BALANCE DISORDER (Balance difficulty) and HEADACHE (Headache) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19.    Co-suspect product included non-company product COVID-19 VACCINE NRVV AD26 (JNJ 78436735) for an unknown indication.    No Medical History information was reported.   In March 2021, the patient started COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (unknown route) at an unspecified dose. 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 and third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VISUAL IMPAIRMENT (Visual Impairment), VISION BLURRED (Blurry vision), BALANCE DISORDER (Balance difficulty) and HEADACHE (Headache). At the time of the report, VISUAL IMPAIRMENT (Visual Impairment), VISION BLURRED (Blurry vision), BALANCE DISORDER (Balance difficulty) and HEADACHE (Headache) outcome was unknown.            Patient felt the same reaction when he took Johnson and Johnson vaccine in march but these was much worse. No concomitant medication information was provided. No treatment medication were provided. Patient did not have any allergies.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Rhinorrhoea
Clinical narrative: runny nose; chest tightness; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (runny nose) and CHEST DISCOMFORT (chest tightness) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RHINORRHOEA (runny nose) and CHEST DISCOMFORT (chest tightness). At the time of the report, RHINORRHOEA (runny nose) and CHEST DISCOMFORT (chest tightness) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Diarrhoea, Feeling abnormal, Feeling cold
Clinical narrative: Diarrhea since got the first shot; Skin was white; Everything hurt so bad.; Just touching my skin hurt.; The first one made me extremely sick; I thought I would die; Headache; Temperature was 99.7°F; Chills/was so cold that needed to enter the shower with hot water; Feeling cold; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea since got the first shot), SKIN DISCOLOURATION (Skin was white), PAIN (Everything hurt so bad.), PAIN OF SKIN (Just touching my skin hurt.) and ILLNESS (The first one made me extremely sick) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. D45C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in December 2020.    On 30-Aug-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 DIARRHOEA (Diarrhea since got the first shot), SKIN DISCOLOURATION (Skin was white), PAIN (Everything hurt so bad.), PAIN OF SKIN (Just touching my skin hurt.), ILLNESS (The first one made me extremely sick), FEELING ABNORMAL (I thought I would die), HEADACHE (Headache), PYREXIA (Temperature was 99.7°F), CHILLS (Chills/was so cold that needed to enter the shower with hot water) and FEELING COLD (Feeling cold). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) ongoing since an unknown date for Adverse event, at an unspecified dose and frequency. At the time of the report, DIARRHOEA (Diarrhea since got the first shot) and HEADACHE (Headache) had not resolved and SKIN DISCOLOURATION (Skin was white), PAIN (Everything hurt so bad.), PAIN OF SKIN (Just touching my skin hurt.), ILLNESS (The first one made me extremely sick), FEELING ABNORMAL (I thought I would die), PYREXIA (Temperature was 99.7°F), CHILLS (Chills/was so cold that needed to enter the shower with hot water) and FEELING COLD (Feeling cold) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99.7°f (High) High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       About the concomitant medications The patient stated that she is taking some gastrointestinal stuff and something to help digest the food.Been taking medicines and homeopathic   This case was linked to MOD-2021-369270 (Patient Link).