chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Vaccination site mass
Clinical narrative: still got the awful twitching; ringing in her ears got worse; heart racing lasted for weeks; fever stayed at 100 F after getting the booster shots; This spontaneous case was reported by a patient and describes the occurrence of MUSCLE TWITCHING (still got the awful twitching), TINNITUS (ringing in her ears got worse), PALPITATIONS (heart racing lasted for weeks) and PYREXIA (fever stayed at 100 F after getting the booster shots) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient had no allergies. The patient had never been tested positive or diagnosed with COVID-19.  Previously administered products included for Drug use for unknown indication: Tylenol; for Product used for unknown indication: pneumococcal vaccine, FLU VACCINE VII (flu vaccine) and Shingles vaccine (Shingles vaccine). Past adverse reactions to the above products included No adverse event with FLU VACCINE VII, Shingles vaccine, Tylenol and pneumococcal vaccine. Concurrent medical conditions included Bronchiectasis.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 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 15-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MUSCLE TWITCHING (still got the awful twitching), TINNITUS (ringing in her ears got worse), PALPITATIONS (heart racing lasted for weeks) and PYREXIA (fever stayed at 100 F after getting the booster shots). At the time of the report, MUSCLE TWITCHING (still got the awful twitching) and TINNITUS (ringing in her ears got worse) had not resolved, PALPITATIONS (heart racing lasted for weeks) had resolved and PYREXIA (fever stayed at 100 F after getting the booster shots) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100 100 degree Fahrenheit.         No concomitant medications were reported.  On 15-Apr-2022, the patient received second booster dose of Moderna COVID-19 vaccine but the patient could not recall the date of administration of the first booster dose of Moderna COVID-19 vaccine.  The patient was afraid and had to decide whether the patient would get the bivalent booster dose or not, as the patient had experienced symptoms after the first 4 doses.  No treatment medications were reported.   This case was linked to MOD-2022-657512, MOD-2022-657532 (Patient Link).
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Body temperature, Diarrhoea, Feeling abnormal, Gait disturbance, Muscle spasms
Clinical narrative: still got the awful twitching; ringing in her ears got worse; heart racing lasted for weeks; fever stayed at 100 F after getting the booster shots; This spontaneous case was reported by a patient and describes the occurrence of MUSCLE TWITCHING (still got the awful twitching), TINNITUS (ringing in her ears got worse), PALPITATIONS (heart racing lasted for weeks) and PYREXIA (fever stayed at 100 F after getting the booster shots) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient had no allergies. The patient had never been tested positive or diagnosed with COVID-19.  Previously administered products included for Drug use for unknown indication: Tylenol; for Product used for unknown indication: pneumococcal vaccine, FLU VACCINE VII (flu vaccine) and Shingles vaccine (Shingles vaccine). Past adverse reactions to the above products included No adverse event with FLU VACCINE VII, Shingles vaccine, Tylenol and pneumococcal vaccine. Concurrent medical conditions included Bronchiectasis.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 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 15-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MUSCLE TWITCHING (still got the awful twitching), TINNITUS (ringing in her ears got worse), PALPITATIONS (heart racing lasted for weeks) and PYREXIA (fever stayed at 100 F after getting the booster shots). At the time of the report, MUSCLE TWITCHING (still got the awful twitching) and TINNITUS (ringing in her ears got worse) had not resolved, PALPITATIONS (heart racing lasted for weeks) had resolved and PYREXIA (fever stayed at 100 F after getting the booster shots) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100 100 degree Fahrenheit.         No concomitant medications were reported.  On 15-Apr-2022, the patient received second booster dose of Moderna COVID-19 vaccine but the patient could not recall the date of administration of the first booster dose of Moderna COVID-19 vaccine.  The patient was afraid and had to decide whether the patient would get the bivalent booster dose or not, as the patient had experienced symptoms after the first 4 doses.  No treatment medications were reported.   This case was linked to MOD-2022-657512, MOD-2022-657532 (Patient Link).
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Muscle twitching, Palpitations, Paraesthesia, Poor quality sleep, Pyrexia
Clinical narrative: still got the awful twitching; ringing in her ears got worse; heart racing lasted for weeks; fever stayed at 100 F after getting the booster shots; This spontaneous case was reported by a patient and describes the occurrence of MUSCLE TWITCHING (still got the awful twitching), TINNITUS (ringing in her ears got worse), PALPITATIONS (heart racing lasted for weeks) and PYREXIA (fever stayed at 100 F after getting the booster shots) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient had no allergies. The patient had never been tested positive or diagnosed with COVID-19.  Previously administered products included for Drug use for unknown indication: Tylenol; for Product used for unknown indication: pneumococcal vaccine, FLU VACCINE VII (flu vaccine) and Shingles vaccine (Shingles vaccine). Past adverse reactions to the above products included No adverse event with FLU VACCINE VII, Shingles vaccine, Tylenol and pneumococcal vaccine. Concurrent medical conditions included Bronchiectasis.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 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 15-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MUSCLE TWITCHING (still got the awful twitching), TINNITUS (ringing in her ears got worse), PALPITATIONS (heart racing lasted for weeks) and PYREXIA (fever stayed at 100 F after getting the booster shots). At the time of the report, MUSCLE TWITCHING (still got the awful twitching) and TINNITUS (ringing in her ears got worse) had not resolved, PALPITATIONS (heart racing lasted for weeks) had resolved and PYREXIA (fever stayed at 100 F after getting the booster shots) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100 100 degree Fahrenheit.         No concomitant medications were reported.  On 15-Apr-2022, the patient received second booster dose of Moderna COVID-19 vaccine but the patient could not recall the date of administration of the first booster dose of Moderna COVID-19 vaccine.  The patient was afraid and had to decide whether the patient would get the bivalent booster dose or not, as the patient had experienced symptoms after the first 4 doses.  No treatment medications were reported.   This case was linked to MOD-2022-657512, MOD-2022-657532 (Patient Link).
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Tension, Tremor, Vision blurred
Clinical narrative: still got the awful twitching; ringing in her ears got worse; heart racing lasted for weeks; fever stayed at 100 F after getting the booster shots; This spontaneous case was reported by a patient and describes the occurrence of MUSCLE TWITCHING (still got the awful twitching), TINNITUS (ringing in her ears got worse), PALPITATIONS (heart racing lasted for weeks) and PYREXIA (fever stayed at 100 F after getting the booster shots) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient had no allergies. The patient had never been tested positive or diagnosed with COVID-19.  Previously administered products included for Drug use for unknown indication: Tylenol; for Product used for unknown indication: pneumococcal vaccine, FLU VACCINE VII (flu vaccine) and Shingles vaccine (Shingles vaccine). Past adverse reactions to the above products included No adverse event with FLU VACCINE VII, Shingles vaccine, Tylenol and pneumococcal vaccine. Concurrent medical conditions included Bronchiectasis.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 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 15-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MUSCLE TWITCHING (still got the awful twitching), TINNITUS (ringing in her ears got worse), PALPITATIONS (heart racing lasted for weeks) and PYREXIA (fever stayed at 100 F after getting the booster shots). At the time of the report, MUSCLE TWITCHING (still got the awful twitching) and TINNITUS (ringing in her ears got worse) had not resolved, PALPITATIONS (heart racing lasted for weeks) had resolved and PYREXIA (fever stayed at 100 F after getting the booster shots) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100 100 degree Fahrenheit.         No concomitant medications were reported.  On 15-Apr-2022, the patient received second booster dose of Moderna COVID-19 vaccine but the patient could not recall the date of administration of the first booster dose of Moderna COVID-19 vaccine.  The patient was afraid and had to decide whether the patient would get the bivalent booster dose or not, as the patient had experienced symptoms after the first 4 doses.  No treatment medications were reported.   This case was linked to MOD-2022-657512, MOD-2022-657532 (Patient Link).
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial was initially stored in the refrigerator on 08-Sep-2022 and was administered on 10-Oct-2022; No adverse event; Patient received a vaccine past 30 days in the fridge; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received a vaccine past 30 days in the fridge), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 08-Sep-2022 and was administered on 10-Oct-2022) and NO ADVERSE EVENT (No adverse event) in a 42-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 055A22A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma. Concomitant products included LEVOTHYROXINE, FLUOXETINE, MONTELUKAST SODIUM (SINGULAIR), FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR), OMEPRAZOLE and SALBUTAMOL (VENTOLIN [SALBUTAMOL]) for an unknown indication.    On 10-Oct-2022, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter. On 10-Oct-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received a vaccine past 30 days in the fridge). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 08-Sep-2022 and was administered on 10-Oct-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received a vaccine past 30 days in the fridge), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 08-Sep-2022 and was administered on 10-Oct-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient received a vaccine past 30 days in the fridge) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 08-Sep-2022 and was administered on 10-Oct-2022).    Patient was taking other medication. The vial size was 5.5 ml. The vial did not undergo any temperature excursions. No treatment medication was reported.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Nausea, Pyrexia
Clinical narrative: Low-grade fever of 99.9, normally it is 97.6,4 days of fevers; somewhat nauseous; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (Low-grade fever of 99.9, normally it is 97.6,4 days of fevers) and NAUSEA (somewhat nauseous) in a 69-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7166) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Oct-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 08-Oct-2022, the patient experienced PYREXIA (Low-grade fever of 99.9, normally it is 97.6,4 days of fevers) and NAUSEA (somewhat nauseous). At the time of the report, PYREXIA (Low-grade fever of 99.9, normally it is 97.6,4 days of fevers) and NAUSEA (somewhat nauseous) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Oct-2022, Body temperature: 99.9. On an unknown date, Body temperature: 97.6.         No concomitant medication details was reported. No treatment medication details was reported. It was reported that all of her 5 doses were Moderna vaccines.  Patient experienced fever going on for more than 1-3 days.   Reporter did not allow further contact
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Limb discomfort, Musculoskeletal stiffness
Clinical narrative: really strange locked up shoulder issues/Both my shoulders were locked up/My range of motion in my shoulders really isn't that great; I've lost use of my arms.; This spontaneous case was reported by a patient and describes the occurrence of MUSCULOSKELETAL STIFFNESS (really strange locked up shoulder issues/Both my shoulders were locked up/My range of motion in my shoulders really isn't that great) and LIMB DISCOMFORT (I've lost use of my arms.) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939904, 013M20A and 013L20A) for COVID-19 prophylaxis.     The patient's past medical history included Shoulder operation (right shoulder, laparoscopically).   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Oct-2022, the patient experienced LIMB DISCOMFORT (I've lost use of my arms.). On an unknown date, the patient experienced MUSCULOSKELETAL STIFFNESS (really strange locked up shoulder issues/Both my shoulders were locked up/My range of motion in my shoulders really isn't that great). At the time of the report, MUSCULOSKELETAL STIFFNESS (really strange locked up shoulder issues/Both my shoulders were locked up/My range of motion in my shoulders really isn't that great) was resolving and LIMB DISCOMFORT (I've lost use of my arms.) outcome was unknown.            No concomitant medication information provided. It was reported that patient had done physical therapy and was little better, but it was not easy for him. No treatment information provided.   This case was linked to MOD-2021-253049 (Patient Link).
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Feeling hot, Peripheral swelling, Pyrexia, Vaccination site pain
Clinical narrative: Arm was swollen; Arm was warm; fever; very sore left arm; feeling tired; This spontaneous case was reported by a patient and describes the occurrence of PERIPHERAL SWELLING (Arm was swollen), FEELING HOT (Arm was warm), PYREXIA (fever), VACCINATION SITE PAIN (very sore left arm) and FATIGUE (feeling tired) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M21A, 076C21A and 015M20A) for COVID-19 vaccination.     The patient's past medical history included Aortic valve replacement in 2017, Mitral valve repair in 2017 and Scar removal (Scar tissue in colon) in 2018. Concomitant products included INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]), METOPROLOL and LOSARTAN for an unknown indication.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Nov-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-May-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-May-2022, the patient experienced PERIPHERAL SWELLING (Arm was swollen), PYREXIA (fever), VACCINATION SITE PAIN (very sore left arm) and FATIGUE (feeling tired). 03-May-2022, the patient experienced FEELING HOT (Arm was warm). At the time of the report, PERIPHERAL SWELLING (Arm was swollen), FEELING HOT (Arm was warm), PYREXIA (fever), VACCINATION SITE PAIN (very sore left arm) and FATIGUE (feeling tired) outcome was unknown.            It was reported that patient went home and went to bed. No treatment information was provided.   This case was linked to MOD-2022-657566 (Patient Link).
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Inappropriate schedule of product administration
Clinical narrative: Arm was swollen; Arm was warm; fever; very sore left arm; feeling tired; This spontaneous case was reported by a patient and describes the occurrence of PERIPHERAL SWELLING (Arm was swollen), FEELING HOT (Arm was warm), PYREXIA (fever), VACCINATION SITE PAIN (very sore left arm) and FATIGUE (feeling tired) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M21A, 076C21A and 015M20A) for COVID-19 vaccination.     The patient's past medical history included Aortic valve replacement in 2017, Mitral valve repair in 2017 and Scar removal (Scar tissue in colon) in 2018. Concomitant products included INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]), METOPROLOL and LOSARTAN for an unknown indication.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Nov-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-May-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-May-2022, the patient experienced PERIPHERAL SWELLING (Arm was swollen), PYREXIA (fever), VACCINATION SITE PAIN (very sore left arm) and FATIGUE (feeling tired). 03-May-2022, the patient experienced FEELING HOT (Arm was warm). At the time of the report, PERIPHERAL SWELLING (Arm was swollen), FEELING HOT (Arm was warm), PYREXIA (fever), VACCINATION SITE PAIN (very sore left arm) and FATIGUE (feeling tired) outcome was unknown.            It was reported that patient went home and went to bed. No treatment information was provided.   This case was linked to MOD-2022-657566 (Patient Link).
Age: 2.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vial was first punctured on 08-Oct-2022 at 9:15 am and was administered at 10-Oct-2022/The vial was stored in fridge post puncture; no adverse event; patient received the vaccine after more than 12 hours post puncture; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received the vaccine after more than 12 hours post puncture), PRODUCT STORAGE ERROR (Vial was first punctured on 08-Oct-2022 at 9:15 am and was administered at 10-Oct-2022/The vial was stored in fridge post puncture) and NO ADVERSE EVENT (no adverse event) in a 2-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR9236B) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Oct-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 10-Oct-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received the vaccine after more than 12 hours post puncture). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was first punctured on 08-Oct-2022 at 9:15 am and was administered at 10-Oct-2022/The vial was stored in fridge post puncture) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient received the vaccine after more than 12 hours post puncture), PRODUCT STORAGE ERROR (Vial was first punctured on 08-Oct-2022 at 9:15 am and was administered at 10-Oct-2022/The vial was stored in fridge post puncture) and NO ADVERSE EVENT (no adverse event) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (patient received the vaccine after more than 12 hours post puncture) and PRODUCT STORAGE ERROR (Vial was first punctured on 08-Oct-2022 at 9:15 am and was administered at 10-Oct-2022/The vial was stored in fridge post puncture).    Concomitant medications were not reported. It was reported that the 2.5 ml sized monovalent individual vial was initially stored in refrigerator on 05-Oct-2022 and was stored in refrigerator itself post puncture. The vial was first punctured on 08-Oct-2022 at 09:15 am and was administered to pediatric patients on 10-Oct-2022 at 10:45 am, 11:15 am and 3:30 pm. It was also reported that the vial did not undergo any temperature excursion and was exposed to room temperature for less than 10 minutes. No adverse events were reported after the vaccine was given. Treatment medications were not reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-657611, US-MODERNATX, INC.-MOD-2022-657614 (Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2022-657611:same reporter. US-MODERNATX, INC.-MOD-2022-657614:same reporter.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; patient received first Moderna Covid-19 vaccine Primary Series Dose on 20-JAN-2021 and second dose of the Moderna Covid-19 vaccine on 26-FEB-2021; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient received first Moderna Covid-19 vaccine Primary Series Dose on 20-JAN-2021 and second dose of the Moderna Covid-19 vaccine on 26-FEB-2021) and NO ADVERSE EVENT (No adverse event) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 025J20-2A) for COVID-19 prophylaxis.     Concurrent medical conditions included Blood pressure high. Concomitant products included AMLODIPINE, HYDROCHLOROTHIAZIDE and LOSARTAN for an unknown indication.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient received first Moderna Covid-19 vaccine Primary Series Dose on 20-JAN-2021 and second dose of the Moderna Covid-19 vaccine on 26-FEB-2021). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient received first Moderna Covid-19 vaccine Primary Series Dose on 20-JAN-2021 and second dose of the Moderna Covid-19 vaccine on 26-FEB-2021) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient received first Moderna Covid-19 vaccine Primary Series Dose on 20-JAN-2021 and second dose of the Moderna Covid-19 vaccine on 26-FEB-2021).    No adverse reactions reported after receiving first and second dose of vaccine. No treatment drug was reported.   This case was linked to MOD-2022-657599 (Patient Link).
Age: 1.58
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vial was first punctured on 08-Oct-2022 at 9:15 am and was administered at 10-Oct-2022/The vial was stored in fridge post puncture; No adverse event; Pediatric patient received the vaccine after more than 12 hours post puncture; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Pediatric patient received the vaccine after more than 12 hours post puncture), PRODUCT STORAGE ERROR (Vial was first punctured on 08-Oct-2022 at 9:15 am and was administered at 10-Oct-2022/The vial was stored in fridge post puncture) and NO ADVERSE EVENT (No adverse event) in a 19-month-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR9236B) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Oct-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 10-Oct-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Pediatric patient received the vaccine after more than 12 hours post puncture). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was first punctured on 08-Oct-2022 at 9:15 am and was administered at 10-Oct-2022/The vial was stored in fridge post puncture) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Pediatric patient received the vaccine after more than 12 hours post puncture), PRODUCT STORAGE ERROR (Vial was first punctured on 08-Oct-2022 at 9:15 am and was administered at 10-Oct-2022/The vial was stored in fridge post puncture) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Pediatric patient received the vaccine after more than 12 hours post puncture) and PRODUCT STORAGE ERROR (Vial was first punctured on 08-Oct-2022 at 9:15 am and was administered at 10-Oct-2022/The vial was stored in fridge post puncture).    No concomitant medications were reported. No treatment details were reported. It was reported that the patient had not experienced any Adverse Events after vaccination. Individual Vial size was reported as 2.5 mL. The vial was initially stored in the refrigerator on 05-Oct-2022. The vial was first punctured on 08-Oct-2022 at 09:15 am and was administered to pediatric patients on 10-Oct-2022 at 10:45 am, 11:15 am and 3:30 pm. Vial was stored in the fridge post puncture. Vial did not undergo any temperature excursions. Total amount of time the vial was exposed to room temperature range was less than 10 minutes. This case contains information for the 2nd of 3 Patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-657574, MOD-2022-657614.; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-657574:same reporter MOD-2022-657614:same reporter
Age: 0.67
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event; 3 pediatric patients received the vaccine after more than 12 hours post puncture; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (3 pediatric patients received the vaccine after more than 12 hours post puncture) and NO ADVERSE EVENT (no adverse event) in an 8-month-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR9236B) for COVID-19 vaccination. No Medical History information was reported. On 10-Oct-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 10-Oct-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (3 pediatric patients received the vaccine after more than 12 hours post puncture). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (3 pediatric patients received the vaccine after more than 12 hours post puncture) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (3 pediatric patients received the vaccine after more than 12 hours post puncture).    No concomitant medications were reported. Vail size was reported as 2.5 mL. Vial was initially stored in the refrigerator on 5 OCT-2022. It was first punctured on 08-OCT-2022 9:15 am and vaccine was administered on 10-OCT-2022 on 10:45 am, 11:15 am and 3:30 pm. Vial was stored in fridge post puncture. Vial did not undergo any temperature excursions. Total amount of time the vial was exposed to room temperature range (8 to 25 degree Celsius-46 to 77 degree Fahrenheit) was less than 10 minutes. No treatment information was provided. This case was linked to US-MODERNATX, INC.-MOD-2022-657574, US-MODERNATX, INC.-MOD-2022-657611 (Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2022-657574:same reporter US-MODERNATX, INC.-MOD-2022-657611:same reporter.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction, Loss of personal independence in daily activities, Migraine, Vomiting
Clinical narrative: all sort of symptoms; migraines/headaches; she can't do anything physical and not able to work now; vomiting profusely; This spontaneous case was reported by an attorney and describes the occurrence of IMMUNISATION REACTION (all sort of symptoms), MIGRAINE (migraines/headaches), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (she can't do anything physical and not able to work now) and VOMITING (vomiting profusely) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 27-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In September 2021, the patient experienced IMMUNISATION REACTION (all sort of symptoms), MIGRAINE (migraines/headaches), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (she can't do anything physical and not able to work now) and VOMITING (vomiting profusely). At the time of the report, IMMUNISATION REACTION (all sort of symptoms), MIGRAINE (migraines/headaches), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (she can't do anything physical and not able to work now) and VOMITING (vomiting profusely) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported. Patient thought it was a gallbladder, She went and saw surgeon. Patient was on a gallbladder diet. Patient used to be very active and now she could not do anything physical. No treatment information was provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: product was stored in the refrigerator one day beyond the before use date (10 week period). Two shots of these vials were administered.; product was stored in the refrigerator one day beyond the before use date (10 week period). Two shots of these vials were administered.; This case was considered invalid as unspecified number of patients involved.   This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team, Program ID. A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: POOR QUALITY PRODUCT ADMINISTERED (non-serious), PRODUCT ADMINISTRATION ERROR (non-serious) and all described as "product was stored in the refrigerator one day beyond the before use date (10 week period). Two shots of these vials were administered.".  Additional information: The reporter had requested the viability information for the COVID-19 vaccine gray cap, the product was stored in the refrigerator one day beyond the before use date (10 week period). Two shots of these vials were administered. The patient received gray cap administered a couple of vaccines to a patient that was beyond use date. She wanted to know if vaccines are still viable or not.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.  Follow-up (09Aug2022): This is a spontaneous follow-up report received from the same pharmacist.   Updated information Included: clarified that no definite number of patients received the product (stored in the refrigerator one day beyond the before use date of 10-week period) and confirmed it was more than one patient.  Follow-up (10Oct2022): Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201046437 same reporter/drug/event, different patient;
Sex: F
Vaccine: COVID19
Symptoms: Psoriasis, Rash
Clinical narrative: She had another booster shot last Sep 2022 and when she woke up it was all over her body; She had another booster shot last Sep 2022 and when she woke up it was all over her body; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), on 20Sep2022 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: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 Immunization; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), administration date: Apr2021, for COVID-19 Immunization, reaction(s): "Caller mentioned she had a booster shot last April of the Pfizer Covid-19 vaccine. She woke up when had some rash on her legs and the doctor told her it's psoriasis.", "Caller mentioned she had a booster shot last April of the Pfizer Covid-19 vaccine. She woke up when had some rash on her legs and the doctor told her it's psoriasis.". The following information was reported: PSORIASIS (non-serious), RASH (non-serious) all with onset Sep2022, outcome "unknown" and all described as "She had another booster shot last Sep 2022 and when she woke up it was all over her body".  Additional Information: The patient received another last Sep 2022 and when she woke up it was all over her body. She would like to know if there is any medication for that.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202200078216 same reporter/patient/adverse events and different dose number;
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), in Feb2021 as dose 1, single (Batch/Lot number: unknown), in Mar2021 as dose 2, single (Batch/Lot number: unknown), in Aug2021 as dose 3 (booster), single (Batch/Lot number: unknown) and in Oct2021 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: LEVOTHYROXINE SODIUM. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Vaccinated in the beginning but did not get the Boosters on time and came down with COVID; Vaccinated in the beginning but did not get the Boosters on time and came down with COVID; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hepatitis B" (unspecified if ongoing), notes: Hepatitis B. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "Vaccinated in the beginning but did not get the Boosters on time and came down with COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive; Negative, notes: because I took the Paxlovid and I am recovered and tested negative for the COVID. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201212594 same reporter, same patient, different product, different event;US-PFIZER INC-202201212777 same reporter, same patient, different product, different event;
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 72-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Sep2022 at 03:45 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 72 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), 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 included: "asthma" (unspecified if ongoing); "COPD" (unspecified if ongoing); "cancer survivor" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment; Positive, notes: day 9 with persistent positive tests. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the available information, the reported events Drug ineffective and Covid-19 cannot be excluded for the suspect drug (BNT162B2, BNT162B2 OMI BA.4-5).
Sex: M
Vaccine: COVID19
Symptoms: Hydrocephalus, SARS-CoV-2 test, Sleep apnoea syndrome
Clinical narrative: 3 months after the shot, I was diagnosed with Hydrocephalus; Sleep Apnea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old male patient received BNT162b2 (BNT162B2), on 19Mar2021 at 17:15 as dose 2, single (Lot number: EN6208), in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (prev dose product=COVID 19, prev dose brand= Pfizer, prev dose brand unknown= False, is bivalent=False, prev dose lot number=E N6200, prev dose lot unknown= False, prev dose administration date=26Feb2021, prev dose dose number= 1, prev dose vaccine location= Right arm), administration date: 26Feb2021, when the patient was 66-year-old, for COVID-19 immunization. The following information was reported: HYDROCEPHALUS (hospitalization, medically significant) with onset 01Jun2021, outcome "recovered", described as "3 months after the shot, I was diagnosed with Hydrocephalus"; SLEEP APNOEA SYNDROME (hospitalization, medically significant) with onset 01Jun2021, outcome "recovered", described as "Sleep Apnea". The patient was hospitalized for hydrocephalus, sleep apnoea syndrome (hospitalization duration: 1 day(s)). The events "3 months after the shot, i was diagnosed with hydrocephalus" and "sleep apnea" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (01Sep2022) Negative. Therapeutic measures were taken as a result of hydrocephalus, sleep apnoea syndrome. Patient did not receive any other vaccine in four weeks and did not receive other medication in two weeks. Patient did not have covid prior vaccination. 3 months after the shot, patient was diagnosed with Hydrocephalus and Sleep Apnea with no previous symptoms or history. Patient needed surgery for the Hydrocephalus. Hospitalized for one day. No known allergies. No other medical history.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Vaccinated in the beginning but did not get the Boosters on time and came down with COVID; Vaccinated in the beginning but did not get the Boosters on time and came down with COVID; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A male patient received BNT162b2 (BNT162B2), as dose number unknown, 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 "recovered" and all described as "Vaccinated in the beginning but did not get the Boosters on time and came down with COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Vaccinated in the beginning but did not get the Boosters on time and came down with COVID; negative, notes: her and her son were negative.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Still Covid positive - rebound.  Covid like symptoms after treatment; Still Covid positive - rebound.  Covid like symptoms after treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old male patient received BNT162b2 (BNT162B2), on 08Mar2021 as dose 2, single (Batch/Lot number: unknown) at the age of 67 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "allergies" (unspecified if ongoing), notes: known allergies: Yes. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Still Covid positive - rebound. Covid like symptoms after treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment; Positive, notes: Still Covid positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 with antiviral drug. Treatment start date was 29Sep2022 and treatment stop date was 03Oct2022.   Clinical course: The patient reported that he was Still Covid positive - rebound. Covid like symptoms after treatment. The patient had some known allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.