chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Gait disturbance, Vertigo
Clinical narrative: It's worst when I'm lying down/The room is spinning when lying down.; difficulty walking/walking into walls/I was walking sideways; dizziness; This spontaneous case was reported by a patient and describes the occurrence of VERTIGO (It's worst when I'm lying down/The room is spinning when lying down.), GAIT DISTURBANCE (difficulty walking/walking into walls/I was walking sideways) and DIZZINESS (dizziness) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059A22A) for COVID-19 prophylaxis.     It was unknown that patient ever had COVID + test or diagnosis.  Previously administered products included for Product used for unknown indication: Pfizer (Dose Number: 1st dose Lot number: EW0161 Dose: full dose) on 17-Apr-2021, Pfizer (Dose Number: 2nd dose Lot number: ER8736 Dose: full dose) on 08-May-2021 and Pfizer (Dose Number: 1st booster Lot number: FJ1611 Dose: booster dose) on 08-Nov-2021. Past adverse reactions to the above products included No adverse event with Pfizer, Pfizer and Pfizer. Concurrent medical conditions included Hypertension and Diabetes.    On 09-Jun-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jun-2022, the patient experienced GAIT DISTURBANCE (difficulty walking/walking into walls/I was walking sideways) and DIZZINESS (dizziness). On 14-Jun-2022, the patient experienced VERTIGO (It's worst when I'm lying down/The room is spinning when lying down.). At the time of the report, VERTIGO (It's worst when I'm lying down/The room is spinning when lying down.) and DIZZINESS (dizziness) had not resolved and GAIT DISTURBANCE (difficulty walking/walking into walls/I was walking sideways) was resolving.            Concomitant medications was not provided by the reporter. It was unknown that recent change in status such as improvement or worsening.  Adverse event did not cause patient to seek medical care (office visit, Urgent care, ER, hospitalized).  Treatment information was not provided.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Fear of disease, Pain, Swelling, Vaccination complication
Clinical narrative: Pain; Swelling; Afraid of Vaccine effects/ Fear of disease; Afraid Vaccination effects; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain), SWELLING (Swelling), FEAR OF DISEASE (Afraid of Vaccine effects/ Fear of disease) and VACCINATION COMPLICATION (Afraid Vaccination effects) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.   On 01-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) . On an unknown date, the patient experienced PAIN (Pain), SWELLING (Swelling), FEAR OF DISEASE (Afraid of Vaccine effects/ Fear of disease) and VACCINATION COMPLICATION (Afraid Vaccination effects). At the time of the report, PAIN (Pain) and SWELLING (Swelling) was resolving and FEAR OF DISEASE (Afraid of Vaccine effects/ Fear of disease) and VACCINATION COMPLICATION (Afraid Vaccination effects) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.  It was unknown if patient was enrolled in clinical trial.  Indication for HUMIRA reported as RHEUMATOID ARTHRITIS, with daily dose. The causality with respect to Humira for the event Fear of disease, Swelling and Pain was reported as Not Reported.  No treatment drug information was provided.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Body temperature, Nausea, Pain, Pyrexia, Vomiting
Clinical narrative: Had ache and pain that usually goes with fever; Nausea; Throwing up; Had a fever of 101.5 F for 3 days; This spontaneous case was reported by a patient and describes the occurrence of PAIN (Had ache and pain that usually goes with fever), NAUSEA (Nausea), VOMITING (Throwing up) and PYREXIA (Had a fever of 101.5 F for 3 days) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 010M20A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Feb-2021, the patient experienced PYREXIA (Had a fever of 101.5 F for 3 days). On an unknown date, the patient experienced PAIN (Had ache and pain that usually goes with fever), NAUSEA (Nausea) and VOMITING (Throwing up). On 28-Feb-2021, PYREXIA (Had a fever of 101.5 F for 3 days) had resolved. At the time of the report, PAIN (Had ache and pain that usually goes with fever) had resolved and NAUSEA (Nausea) and VOMITING (Throwing up) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, Body temperature: 101.5 f (High) 101.5 F. Patient was on some medications. No treatment medications was reported.   This case was linked to MOD-2022-589356, MOD-2022-589308 (Patient Link).
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Rash macular, Vaccination site erythema
Clinical narrative: Had ache and pain that usually goes with fever; Nausea; Throwing up; Had a fever of 101.5 F for 3 days; This spontaneous case was reported by a patient and describes the occurrence of PAIN (Had ache and pain that usually goes with fever), NAUSEA (Nausea), VOMITING (Throwing up) and PYREXIA (Had a fever of 101.5 F for 3 days) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 010M20A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Feb-2021, the patient experienced PYREXIA (Had a fever of 101.5 F for 3 days). On an unknown date, the patient experienced PAIN (Had ache and pain that usually goes with fever), NAUSEA (Nausea) and VOMITING (Throwing up). On 28-Feb-2021, PYREXIA (Had a fever of 101.5 F for 3 days) had resolved. At the time of the report, PAIN (Had ache and pain that usually goes with fever) had resolved and NAUSEA (Nausea) and VOMITING (Throwing up) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, Body temperature: 101.5 f (High) 101.5 F. Patient was on some medications. No treatment medications was reported.   This case was linked to MOD-2022-589356, MOD-2022-589308 (Patient Link).
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Nausea, Rash, Urticaria, Vaccination site lymphadenopathy, Vaccination site mass
Clinical narrative: Had ache and pain that usually goes with fever; Nausea; Throwing up; Had a fever of 101.5 F for 3 days; This spontaneous case was reported by a patient and describes the occurrence of PAIN (Had ache and pain that usually goes with fever), NAUSEA (Nausea), VOMITING (Throwing up) and PYREXIA (Had a fever of 101.5 F for 3 days) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 010M20A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Feb-2021, the patient experienced PYREXIA (Had a fever of 101.5 F for 3 days). On an unknown date, the patient experienced PAIN (Had ache and pain that usually goes with fever), NAUSEA (Nausea) and VOMITING (Throwing up). On 28-Feb-2021, PYREXIA (Had a fever of 101.5 F for 3 days) had resolved. At the time of the report, PAIN (Had ache and pain that usually goes with fever) had resolved and NAUSEA (Nausea) and VOMITING (Throwing up) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, Body temperature: 101.5 f (High) 101.5 F. Patient was on some medications. No treatment medications was reported.   This case was linked to MOD-2022-589356, MOD-2022-589308 (Patient Link).
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose, Inappropriate schedule of product administration
Clinical narrative: Gave 0.5 mL instead of 0.25 mL/ This was the patient's 3rd dose; Inappropriate schedule of vaccine administered; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL OVERDOSE (Gave 0.5 mL instead of 0.25 mL/ This was the patient's 3rd dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059A22A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Johnson & Johnson vaccine (1st Dose: Johnson & Johnson) on 19-Mar-2021 and Pfizer (2nd Dose: Pfizer) on 27-Dec-2021. Past adverse reactions to the above products included No adverse event with Johnson & Johnson vaccine and Pfizer.    On 14-Jun-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 14-Jun-2022, the patient experienced ACCIDENTAL OVERDOSE (Gave 0.5 mL instead of 0.25 mL/ This was the patient's 3rd dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). At the time of the report, ACCIDENTAL OVERDOSE (Gave 0.5 mL instead of 0.25 mL/ This was the patient's 3rd dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) outcome was unknown.    For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product was provided by the reporter. Patient has not reported any adverse reactions to the dose. No treatment medication was provided.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Immunisation reaction
Clinical narrative: side effect as she received the last shot yesterday and she was really suffering; she was too dizzy; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (side effect as she received the last shot yesterday and she was really suffering) and DIZZINESS (she was too dizzy) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.   On 14-Jun-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In June 2022, the patient experienced IMMUNISATION REACTION (side effect as she received the last shot yesterday and she was really suffering) and DIZZINESS (she was too dizzy). At the time of the report, IMMUNISATION REACTION (side effect as she received the last shot yesterday and she was really suffering) and DIZZINESS (she was too dizzy) outcome was unknown.     No Concomitant medication reported. No Treatment medication reported.
Age: 59.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: The vaccine expired on 20-May-2022 and initially stored in refrigerator and administered on 27-May-2022; Expired vaccine doses administered 3 patients/ 3 booster doses administered after manufacturer date of expiry; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine doses administered 3 patients/ 3 booster doses administered after manufacturer date of expiry) and PRODUCT STORAGE ERROR (The vaccine expired on 20-May-2022 and initially stored in refrigerator and administered on 27-May-2022) in a 59-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033K21-2A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 27-May-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 27-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine doses administered 3 patients/ 3 booster doses administered after manufacturer date of expiry). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vaccine expired on 20-May-2022 and initially stored in refrigerator and administered on 27-May-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine doses administered 3 patients/ 3 booster doses administered after manufacturer date of expiry) and PRODUCT STORAGE ERROR (The vaccine expired on 20-May-2022 and initially stored in refrigerator and administered on 27-May-2022) outcome was unknown.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. It was reported that, the reporter noticed the box did not have a expiration date so she scanned the code and noticed the expiration date was 20-May-2022. The vial was initially stored in the refrigerator on 27-May-2022. The vial did not undergo any temperature excursion. No treatment medications were provided.   This case was linked to MOD-2022-587906, MOD-2022-587910 (Patient Link).
Age: 75.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Inappropriate schedule of product administration
Clinical narrative: First dose 20-Mar-2021/Second dose 11-Oct-2021; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose 20-Mar-2021/Second dose 11-Oct-2021) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Psoriatic arthritis.    Concurrent medical conditions included Psoriatic arthritis.   On 20-Mar-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 1 dosage form. On 28-Apr-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) (Solution for injection in pre-filled pen). On 11-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose 20-Mar-2021/Second dose 11-Oct-2021). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose 20-Mar-2021/Second dose 11-Oct-2021) outcome was unknown.    No concomitant medications were reported. It was unknown whether patient was enrolled in a COVID-19 vaccine trial. Primary reporter did not have the lot number information, because the packaging was discarded. No treatment medications were reported.   This case was linked to MOD-2022-589696 (Patient Link).
Age: 89.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Gap between 1st dose and 2nd dose is more than 35 days; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Gap between 1st dose and 2nd dose is more than 35 days) in an 89-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 065K21A and 065K21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 24-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 09-Nov-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 09-Nov-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Gap between 1st dose and 2nd dose is more than 35 days). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Gap between 1st dose and 2nd dose is more than 35 days) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was not reported.  No treatment medication was not reported.   This case was linked to MOD-2022-589275 (Patient Link).
Age: 89.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Gap between 1st dose and 2nd dose is more than 35 days; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Gap between 1st dose and 2nd dose is more than 35 days) in an 89-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 065K21A and 065K21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 24-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 09-Nov-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 09-Nov-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Gap between 1st dose and 2nd dose is more than 35 days). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Gap between 1st dose and 2nd dose is more than 35 days) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was not reported.  No treatment medication was not reported.   This case was linked to MOD-2022-589275 (Patient Link).
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Feeling abnormal
Clinical narrative: dying; This spontaneous case was reported by a patient and describes the occurrence of FEELING ABNORMAL (dying) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040AZ1A and 002B21C) for COVID-19 prophylaxis.     The patient never tested positive for COVID.  Concurrent medical conditions included Type 1 diabetes mellitus. Concomitant products included LEVOTHYROXINE for Hypothyroidism, INSULIN for Type 1 diabetes mellitus.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-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 FEELING ABNORMAL (dying). The patient was treated with EMPAGLIFLOZIN (JARDIANCE) for Type 2 diabetes mellitus, at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (dying) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood glucose: increased blood sugar stays at 600 every bite of food/blood sugars began to increase/H on her meter was over 600 constantly/Every bite of food makes it go up crazy high.         Concomitant medication included all types of vitamin (unspecified).  The patient was dying, blood sugar stays at 600 every bite of food, water makes it go to 400. The patient had high blood sugars 2 weeks after the first dose and sugars began to increase, H on patient meter was over 600 constantly. Every bite of food makes it go up crazy high.  The patient was given some type 2 diabetes medicine to take Jardiance and the patient been taking it for the past two weeks and it was not doing anything.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac stress test, Chest pain, Electrocardiogram
Clinical narrative: Stabbing chest pain on the right side under breast bone and right shoulder blade after the second booster; This spontaneous case was reported by a patient and describes the occurrence of CHEST PAIN (Stabbing chest pain on the right side under breast bone and right shoulder blade after the second booster) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019F21A, 003121-2A, 048B21A and 025B21A) for COVID-19 prophylaxis.     The patient's past medical history included Heart valve replacement (It was reported that for the very first time, the patient got a heart valve) in May 2021. Concurrent medical conditions included Blood pressure high (patient has been taking blood pressure medication for years).   On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Mar-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Mar-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced CHEST PAIN (Stabbing chest pain on the right side under breast bone and right shoulder blade after the second booster). At the time of the report, CHEST PAIN (Stabbing chest pain on the right side under breast bone and right shoulder blade after the second booster) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Cardiac stress test: normal Normal. On an unknown date, Electrocardiogram: normal Normal.         Concomitant medication included blood pressure medication (patient did not remember the name).  On 20-Oct-2021, the patient received first booster dose of Moderna COVID-19 vaccine.  On 31-Mar-2022, the patient received second booster dose of Moderna COVID-19 vaccine.  It was reported that the patient's arteries in the neck were normal.  It was reported that the chest pain used to be like a stabbing pain for the patient that was hard to put up with.  It was reported that the physician told the patient that the patient needed a heart valve replacement and scheduled surgery.  The patient's chest pain had improved 2 months after second booster dose.  No treatment information was reported.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose, Inappropriate schedule of product administration
Clinical narrative: Received 2nd dose more than 35 days after the first dose; Patient received half dose booster instead of the 2nd primary full dose; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received 2nd dose more than 35 days after the first dose) and ACCIDENTAL UNDERDOSE (Patient received half dose booster instead of the 2nd primary full dose) in a 20-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 056M21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 16-Jun-2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 16-Jun-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received 2nd dose more than 35 days after the first dose) and ACCIDENTAL UNDERDOSE (Patient received half dose booster instead of the 2nd primary full dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received 2nd dose more than 35 days after the first dose) and ACCIDENTAL UNDERDOSE (Patient received half dose booster instead of the 2nd primary full dose) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported. Nurse stated 2nd primary dose was given as a half dose by mistake. Nurse stated that, the patient received half dose booster by mistake, instead of the 2nd primary full dose. The 2nd dose was administered more than 35 days after the first Moderna COVID-19 primary full dose.
Age: 74.0
Sex: U
Vaccine: COVID19
Symptoms: Hypersensitivity, Lung disorder, Rhinorrhoea
Clinical narrative: I have a urgent need of a medicine to restore my [unintelligible] nose/he had to prescribe steroids, Prednisone for a runny nose; lungs are damaged now/run down in my lungs; I told him it was an allergy; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (I have a urgent need of a medicine to restore my [unintelligible] nose/he had to prescribe steroids, Prednisone for a runny nose), LUNG DISORDER (lungs are damaged now/run down in my lungs) and HYPERSENSITIVITY (I told him it was an allergy) in a 74-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced RHINORRHOEA (I have a urgent need of a medicine to restore my [unintelligible] nose/he had to prescribe steroids, Prednisone for a runny nose), LUNG DISORDER (lungs are damaged now/run down in my lungs) and HYPERSENSITIVITY (I told him it was an allergy). The patient was treated with PREDNISONE for Runny nose, at an unspecified dose and frequency. At the time of the report, RHINORRHOEA (I have a urgent need of a medicine to restore my [unintelligible] nose/he had to prescribe steroids, Prednisone for a runny nose), LUNG DISORDER (lungs are damaged now/run down in my lungs) and HYPERSENSITIVITY (I told him it was an allergy) had not resolved.     The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medications were reported.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vial was first punctured on 10Jun2022 at 1:05 PM and stored post puncture in a container to protect from the light and kept in the fridge and administered on 13Jun2022.; doses were administered past the 12 hour post puncture period; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses were administered past the 12 hour post puncture period) and PRODUCT STORAGE ERROR (Vial was first punctured on 10Jun2022 at 1:05 PM and stored post puncture in a container to protect from the light and kept in the fridge and administered on 13Jun2022.) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jun-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jun-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses were administered past the 12 hour post puncture period). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was first punctured on 10Jun2022 at 1:05 PM and stored post puncture in a container to protect from the light and kept in the fridge and administered on 13Jun2022.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (doses were administered past the 12 hour post puncture period) and PRODUCT STORAGE ERROR (Vial was first punctured on 10Jun2022 at 1:05 PM and stored post puncture in a container to protect from the light and kept in the fridge and administered on 13Jun2022.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  On 13-Jun-2022, the patient received booster dose (batch no. 058A22-2A) of Moderna COVID-19 Vaccine.  Vial was initially stored in the refrigerator on 09-Jun-2022 and was first punctured on 10-Jun-2022 at 1:05 PM. Post puncture vial was stored in a container to protect from the light and kept in the fridge. All  4 doses administered on 13Jun2022 at 11:24 AM, 12:30 PM, 1:30 PM, 3:00 PM. Vial did not undergo any temperature excursions.Total amount of time the vial was exposed to room temperature range (8 degree to 25 degree C = 46 degree to 77 degree F) was Approximately 5 times, but did not reported a exact amount of time. Vial was not exposed to room temperature for more than 24 hours. It was unknown that Patient was experiencing any symptoms.  No treatment medications were reported.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site movement impairment, Vaccination site pain
Clinical narrative: Trouble raising left arm; Sore left arm injection site; This spontaneous case was reported by a patient family member or friend and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (Trouble raising left arm) and VACCINATION SITE PAIN (Sore left arm injection site) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019F21A, 003121-2A, 048B21A and 025B21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Mar-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Mar-2022, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (Trouble raising left arm) and VACCINATION SITE PAIN (Sore left arm injection site). At the time of the report, VACCINATION SITE MOVEMENT IMPAIRMENT (Trouble raising left arm) and VACCINATION SITE PAIN (Sore left arm injection site) was resolving.    No concomitant medication were reported.  Patient told her doctor, but the doctor does not think it is related to the vaccine. The doctor did not diagnose and did not prescribe any medications to her.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: The patient received Moderna Covid-19 vaccine from a vial that had been punctured on 15 JUN 2022 and dose administered on 16 JUN 2022 more than 12 hours later; patient also recieved Moderna Covid-19 vaccine from a vial that had been at room temperature for 27 hours and 36 minutes.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The patient received Moderna Covid-19 vaccine from a vial that had been punctured on 15 JUN 2022 and dose administered on 16 JUN 2022 more than 12 hours later) and PRODUCT STORAGE ERROR (patient also recieved Moderna Covid-19 vaccine from a vial that had been at room temperature for 27 hours and 36 minutes.) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 059A22A and 058H21A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Dec-2021 at 3:30 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jun-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Jun-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (The patient received Moderna Covid-19 vaccine from a vial that had been punctured on 15 JUN 2022 and dose administered on 16 JUN 2022 more than 12 hours later) and PRODUCT STORAGE ERROR (patient also recieved Moderna Covid-19 vaccine from a vial that had been at room temperature for 27 hours and 36 minutes.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The patient received Moderna Covid-19 vaccine from a vial that had been punctured on 15 JUN 2022 and dose administered on 16 JUN 2022 more than 12 hours later) and PRODUCT STORAGE ERROR (patient also recieved Moderna Covid-19 vaccine from a vial that had been at room temperature for 27 hours and 36 minutes.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was provided  It was reported that the patient received Moderna Covid-19 vaccine from a vial that had been punctured on 15 Jun 2022 and dose administered on 16 Jun 2022 more than 12 hours later. The patient also received Moderna Covid-19 vaccine from a vial that had been at room temperature for 27 hours and 36 minutes.  Treatment medication was not provided by the reporter.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vial was first punctured on 10Jun2022 at 1:05 PM and stored post puncture in a container to protect from the light and kept in the fridge and administered on 13Jun2022; doses were administered past the 12 hour post puncture period; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses were administered past the 12 hour post puncture period) and PRODUCT STORAGE ERROR (Vial was first punctured on 10Jun2022 at 1:05 PM and stored post puncture in a container to protect from the light and kept in the fridge and administered on 13Jun2022) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Jun-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jun-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses were administered past the 12 hour post puncture period). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was first punctured on 10Jun2022 at 1:05 PM and stored post puncture in a container to protect from the light and kept in the fridge and administered on 13Jun2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (doses were administered past the 12 hour post puncture period) and PRODUCT STORAGE ERROR (Vial was first punctured on 10Jun2022 at 1:05 PM and stored post puncture in a container to protect from the light and kept in the fridge and administered on 13Jun2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  On 13-Jun-2022, the patient received booster dose (batch no. 058A22-2A) of Moderna COVID-19 Vaccine.  Vial was initially stored in the refrigerator on 09-Jun-2022 and was first punctured on 10-Jun-2022 at 1:05 PM. Post puncture vial was stored in a container to protect from the light and kept in the fridge. All 4 doses administered on 13Jun2022 at 11:24 AM, 12:30 PM, 1:30 PM, 3:00 PM. Vial did not undergo any temperature excursions. Total amount of time the vial was exposed to room temperature range (8 degree to 25 degree C = 46 degree to 77 degree F) was Approximately 5 times, but did not reported a exact amount of time. Vial was not exposed to room temperature for more than 24 hours. It was unknown that Patient was experiencing any symptoms.  No treatment medications were reported.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: no ADE's.  Pt wasn't old enough to have received moderna.  Should have received Pfizer booster.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: NO ADVERSE EVENT!   I am filling out this form to report that I have a history of Guillian Barré Syndrome (1966 at age 10) and I have had NO adverse event from Covid vaccinations - first series of two were Pfizer, 1st booster was Pfizer, 2nd booster was Moderna.  Please enter this report in the data so that people who have a history of GBS will not be afraid to get vaccinated.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Asthenia, COVID-19, Chills, Dizziness
Clinical narrative: First 5 days, had reactions of slight chills, muscle aches, dizziness, fatigue, all my joints were inflamed  and itching on injection site.  Took Tylenol, Motrin and Methylprednisolone for the reactions and joint pains with moderate relief. On June 2, 2022 woke up with a very painful sore throat, low grade fever between 99.2-99.8F,  muscles very sore, severe fatigue ?no energy the entire day,? dizziness and  difficulty swallowing.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Fatigue, Injection site pruritus, Myalgia, Oropharyngeal pain
Clinical narrative: First 5 days, had reactions of slight chills, muscle aches, dizziness, fatigue, all my joints were inflamed  and itching on injection site.  Took Tylenol, Motrin and Methylprednisolone for the reactions and joint pains with moderate relief. On June 2, 2022 woke up with a very painful sore throat, low grade fever between 99.2-99.8F,  muscles very sore, severe fatigue ?no energy the entire day,? dizziness and  difficulty swallowing.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test positive
Clinical narrative: First 5 days, had reactions of slight chills, muscle aches, dizziness, fatigue, all my joints were inflamed  and itching on injection site.  Took Tylenol, Motrin and Methylprednisolone for the reactions and joint pains with moderate relief. On June 2, 2022 woke up with a very painful sore throat, low grade fever between 99.2-99.8F,  muscles very sore, severe fatigue ?no energy the entire day,? dizziness and  difficulty swallowing.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Electrocardiogram abnormal, Myocarditis, Palpitations
Clinical narrative: Heart palpitations.
Sex: F
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: while rinsing my hair, a clump of hairs came out in my hand; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (005570). The reporter is the patient.  A 66-year-old female patient received BNT162b2 (BNT162B2), on 27May2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose number: 2), administration date: 31Mar2021, for covid-19 immunization; Covid-19 vaccine (Dose number: 1, manufacture unknown), for covid-19 immunization; Covid-19 vaccine (Dose number: 3 (Booster), manufacture unknown), for covid-19 immunization. The following information was reported: ALOPECIA (non-serious) with onset 29May2022, outcome "unknown", described as "while rinsing my hair, a clump of hairs came out in my hand".  Additional information: Caller states that she has sent an email regarding her hair loss after receiving the vaccine and booster. and was sent an email encouraging to contact Pfizer INT number #" I got my 2nd dose of the Pfizer on 31Mar21. Starting in April of 2021 I noticed my hair started to fall out at an alarming rate. I have since lost 50% of my hair mass. I just got my 2nd booster on 5/27. On Sunday 2 days later while rinsing my hair, a clump of hairs came out in my hand. Is there a treatment to counteract the effects of the vaccine that causes hair loss?  Proposed response: Per PI and attached VR, refer to HCP: A review of the Prescribing information of the Pfizer Covid 19 vaccine did not find any information regarding hair loss. Beyond what is described in the Prescribing Information, Pfizer does not provide any recommendations regarding the management or treatment of potential symptoms that a patient may experience. Your healthcare provider is in the best position to advise you about the appropriate action to take as they are most familiar with your medical condition, clinical history, how your treatment has been conducted and any relevant information to your specific case.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Caller states he has received four Pfizer vaccines, tested positive for Covid on Saturday/ they would do a Covid test and it came back positive; Caller states he has received four Pfizer vaccines, tested positive for Covid on Saturday/ they would do a Covid test and it came back positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 69-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Caller states he has received four Pfizer vaccines, tested positive for Covid on Saturday/ they would do a Covid test and it came back positive". The events "caller states he has received four pfizer vaccines, tested positive for covid on saturday/ they would do a covid test and it came back positive" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021215783 Same Reporter/Patient/Drug, Diferent AE/Vaccine Dose;
Sex: M
Vaccine: COVID19
Symptoms: Insomnia, Vaccination site movement impairment, Vaccination site pain
Clinical narrative: severe pain at the site where the tip of the syringe entered his arms at the time of injection; taken away mobility in his arms; makes it difficult for him to sleep; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), in left arm and as dose 2, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), 8 months after the suspect product(s) administration, outcome "unknown", described as "severe pain at the site where the tip of the syringe entered his arms at the time of injection"; VACCINATION SITE MOVEMENT IMPAIRMENT (non-serious), 8 months after the suspect product(s) administration, outcome "unknown", described as "taken away mobility in his arms"; INSOMNIA (non-serious), 8 months after the suspect product(s) administration, outcome "unknown", described as "makes it difficult for him to sleep".  Additional information: It was reported that the patient received his first dose in the left arm and one month after the second dose in the right arm, approximately 7 months later, experienced events. The pain was very severe and had reduced the mobility in his arms. The pain was very severe when he lifts his arms, his left arm has lost approximately 50% of mobility. He works in a restaurant and this had made it difficult for him to carry heavy objects like pots. The pain he feels was internal. He also wanted to know what he can do to reduce the pain. Reported that he may call in the future to review if his pain treatment could interfere with his vaccination schedule. If the pain continues, he would have to stop working.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Dyspnoea, Headache, Nasopharyngitis, Nausea
Clinical narrative: This is a spontaneous report received from contactable consumer or other non-HCP (the patient: 20220530000746). A male patient received the 4th (booster) dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), single dose, for COVID-19 immunization. Medical history and concomitant medications not reported. Vaccination history included the 1st, 2nd and 3rd dose BNT162B2 (Pfizer-BioNTech COVID-19 vaccine); all single dose, for COVID-19 immunization. The patient experienced a headache/headache symptoms, nasopharyngitis/head cold/"stuffed-up" head, abdominal discomfort/upset stomach/upset stomach is worse, nausea and dyspnea/can't breathe, with outcome of unknown. Additional information: Patient asked whether his symptoms could be from Pfizer COVID-19 vaccine received yesterday. He also reported he started but did not complete a colonoscopy prep. It was rescheduled; upset stomach is worse today. He reported nausea/can't breathe. He had the other shots (three) and did not feel like he felt now. They were all Pfizer. He did not have those symptoms. The information on the batch/lot number for BNT162B2 requested and will be submitted if/when received.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Ocular discomfort, Rash, SARS-CoV-2 test
Clinical narrative: eye complications; face and arm rash; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient received BNT162b2 (BNT162B2), on 04May2021 as dose 2, single (Lot number: EW0168) at the age of 58 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1; Lot number: EW0153; Anatomical location: Left arm; Vaccination time: Afternoon), administration date: 06Apr2021, when the patient was 57-year-old, for covid-19 immunization. The following information was reported: OCULAR DISCOMFORT (non-serious) with onset May2021, outcome "recovered" (Mar2022), described as "eye complications"; RASH (non-serious) with onset May2021, outcome "recovered" (Mar2022), described as "face and arm rash". The events "eye complications" and "face and arm rash" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient did not had any medical history. The patient did not receive any concomitant drugs within the two weeks before the event onset. The patient did not receive any other vaccination within the four weeks prior to the first administration date of the suspect vaccine(s).   Follow-up attempts are completed. No further information is expected.