chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Blood albumin decreased, Blood creatinine normal, Blood culture negative, Cerebral small vessel ischaemic disease, Computerised tomogram head abnormal
Clinical narrative: Patient was undergoing treatment for kidney cancer with axitinib and pembrolizumab.  He was his usual self until the day that he received his Covid vaccine.  He was noted by his wife to be lethargic and confused 3 hours later, and this worsened over the course of the next day.  He presented to the ED for evaluation, where he was found to be disoriented with difficulty responding to questions and ambulating. He was hospitalized for 12 days.  Underwent an extensive workup for his symptoms including brain imaging, infectious workup, laboratory testing which were negative for other causes of his neurological symptoms.  He gradually recovered with physical therapy and returned to his baseline.  His symptoms were attributed by some to his cancer therapy, but he subsequently resumed his cancer therapy (axitinib and pembrolizumab) which he tolerated well without recurrence of severe neurological symptoms, strengthening suspicion that his acute neurological changes were due to the Moderna COVID19 vaccine.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Confusional state, Disorientation, Full blood count normal, Gait disturbance, Lethargy
Clinical narrative: Patient was undergoing treatment for kidney cancer with axitinib and pembrolizumab.  He was his usual self until the day that he received his Covid vaccine.  He was noted by his wife to be lethargic and confused 3 hours later, and this worsened over the course of the next day.  He presented to the ED for evaluation, where he was found to be disoriented with difficulty responding to questions and ambulating. He was hospitalized for 12 days.  Underwent an extensive workup for his symptoms including brain imaging, infectious workup, laboratory testing which were negative for other causes of his neurological symptoms.  He gradually recovered with physical therapy and returned to his baseline.  His symptoms were attributed by some to his cancer therapy, but he subsequently resumed his cancer therapy (axitinib and pembrolizumab) which he tolerated well without recurrence of severe neurological symptoms, strengthening suspicion that his acute neurological changes were due to the Moderna COVID19 vaccine.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Liver function test normal, Metabolic function test normal, Neurological symptom, Slow response to stimuli, Troponin normal
Clinical narrative: Patient was undergoing treatment for kidney cancer with axitinib and pembrolizumab.  He was his usual self until the day that he received his Covid vaccine.  He was noted by his wife to be lethargic and confused 3 hours later, and this worsened over the course of the next day.  He presented to the ED for evaluation, where he was found to be disoriented with difficulty responding to questions and ambulating. He was hospitalized for 12 days.  Underwent an extensive workup for his symptoms including brain imaging, infectious workup, laboratory testing which were negative for other causes of his neurological symptoms.  He gradually recovered with physical therapy and returned to his baseline.  His symptoms were attributed by some to his cancer therapy, but he subsequently resumed his cancer therapy (axitinib and pembrolizumab) which he tolerated well without recurrence of severe neurological symptoms, strengthening suspicion that his acute neurological changes were due to the Moderna COVID19 vaccine.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: White blood cell count normal
Clinical narrative: Patient was undergoing treatment for kidney cancer with axitinib and pembrolizumab.  He was his usual self until the day that he received his Covid vaccine.  He was noted by his wife to be lethargic and confused 3 hours later, and this worsened over the course of the next day.  He presented to the ED for evaluation, where he was found to be disoriented with difficulty responding to questions and ambulating. He was hospitalized for 12 days.  Underwent an extensive workup for his symptoms including brain imaging, infectious workup, laboratory testing which were negative for other causes of his neurological symptoms.  He gradually recovered with physical therapy and returned to his baseline.  His symptoms were attributed by some to his cancer therapy, but he subsequently resumed his cancer therapy (axitinib and pembrolizumab) which he tolerated well without recurrence of severe neurological symptoms, strengthening suspicion that his acute neurological changes were due to the Moderna COVID19 vaccine.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Feeling cold, Injection site induration, Injection site mass, Somnolence
Clinical narrative: Feeling of having too much of a medication like benadryl - within a few hours after injection  Sleepy- within a few hours after injection  Very cold - within a few hours after injection  Hard lump at sight of injection- 12 hours after injection
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Alcohol use, Atrial fibrillation, Electrocardiogram abnormal, Headache, Heart rate abnormal
Clinical narrative: 35 yo man with history of von Willebrand disease who received his first dose of the Pfizer COVID 19 vaccine on 5/28, then subsequently drank several alcoholic drinks. The next day he noted on his Apple watch that his heart rate was "all over the place," up to the 200's at times.  He did feel that his heart was racing and felt a pounding in his ears, and felt lethargic at times. He did not notice significant chest pain or dyspnea.  He presented to the ED where he was noted to be in atrial fibrillation with rapid ventricular rate to the 180's, and was admitted for further management.  He had persistent rapid ventricular rate despite q6h metoprolol (with HR up to the 160s-170s with ambulation) so was put on a diltiazem drip.  The medical team had planned for a trans esophageal echo and cardioversion, but he eventually converted to normal sinus rhythm and was discharged.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Lethargy, Palpitations
Clinical narrative: 35 yo man with history of von Willebrand disease who received his first dose of the Pfizer COVID 19 vaccine on 5/28, then subsequently drank several alcoholic drinks. The next day he noted on his Apple watch that his heart rate was "all over the place," up to the 200's at times.  He did feel that his heart was racing and felt a pounding in his ears, and felt lethargic at times. He did not notice significant chest pain or dyspnea.  He presented to the ED where he was noted to be in atrial fibrillation with rapid ventricular rate to the 180's, and was admitted for further management.  He had persistent rapid ventricular rate despite q6h metoprolol (with HR up to the 160s-170s with ambulation) so was put on a diltiazem drip.  The medical team had planned for a trans esophageal echo and cardioversion, but he eventually converted to normal sinus rhythm and was discharged.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Laboratory test, Muscle spasms, Ultrasound scan
Clinical narrative: 4/7/2021: 1st Pfizer  - she had no issues 5/7/2021: 2nd Pfizer shot.  She said she got extreme cramping in her right calf about 12 hours after her shot.  A few days later, the cramping continued and progressed, she went to the ED.  In ED, she was diagnosed with bilateral calf DVTs and was started on Xarelto. She had hypercoagulation workup which was negative (ATIII, protein C, FVL, PTGM)
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Angiogram pulmonary abnormal, Dyspnoea, Fibrin D dimer increased, Full blood count, Haematocrit increased
Clinical narrative: Patient was in her usual state of health until she received her second Moderna vaccine and also took HCTZ, newly prescribed for hypertension. She subsequently developed acute dyspnea, nausea, and emesis. EMS was called, and she was hypoxic, given epinephrine, solumedrol, and benadryl.  She was admitted to the ICU for further care. She required supplemental oxygen but never required intubation.  Labs notable for extremely high D dimer and erythrocytosis. Workup for thromboembolism, including CTA chest and LENIs were negative.  She gradually improved with diuresis and was ultimately discharged.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Haemoglobin increased, Hypoxia, Intensive care, Lung opacity, Nausea
Clinical narrative: Patient was in her usual state of health until she received her second Moderna vaccine and also took HCTZ, newly prescribed for hypertension. She subsequently developed acute dyspnea, nausea, and emesis. EMS was called, and she was hypoxic, given epinephrine, solumedrol, and benadryl.  She was admitted to the ICU for further care. She required supplemental oxygen but never required intubation.  Labs notable for extremely high D dimer and erythrocytosis. Workup for thromboembolism, including CTA chest and LENIs were negative.  She gradually improved with diuresis and was ultimately discharged.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Platelet count normal, Pleural effusion, Polycythaemia, Polyuria, Pulmonary mass
Clinical narrative: Patient was in her usual state of health until she received her second Moderna vaccine and also took HCTZ, newly prescribed for hypertension. She subsequently developed acute dyspnea, nausea, and emesis. EMS was called, and she was hypoxic, given epinephrine, solumedrol, and benadryl.  She was admitted to the ICU for further care. She required supplemental oxygen but never required intubation.  Labs notable for extremely high D dimer and erythrocytosis. Workup for thromboembolism, including CTA chest and LENIs were negative.  She gradually improved with diuresis and was ultimately discharged.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pulmonary oedema, Superinfection, Ultrasound Doppler normal, Vomiting, White blood cell count decreased
Clinical narrative: Patient was in her usual state of health until she received her second Moderna vaccine and also took HCTZ, newly prescribed for hypertension. She subsequently developed acute dyspnea, nausea, and emesis. EMS was called, and she was hypoxic, given epinephrine, solumedrol, and benadryl.  She was admitted to the ICU for further care. She required supplemental oxygen but never required intubation.  Labs notable for extremely high D dimer and erythrocytosis. Workup for thromboembolism, including CTA chest and LENIs were negative.  She gradually improved with diuresis and was ultimately discharged.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Breast pain, Fatigue, Hypoaesthesia, Injection site hypoaesthesia
Clinical narrative: The pain from the injection has never gone.  It?s spread into the side of my left bust and shoulder.  I have numbing in my left arm that?s spread down into my fingers and now numbing at the front of my right leg.  I feel fatigue and like my memory is blurred.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Memory impairment
Clinical narrative: The pain from the injection has never gone.  It?s spread into the side of my left bust and shoulder.  I have numbing in my left arm that?s spread down into my fingers and now numbing at the front of my right leg.  I feel fatigue and like my memory is blurred.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: My arm was very sore
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Electrocardiogram, Menstruation delayed, Palpitations
Clinical narrative: My period was late and I?ve developed palpitations ever since receiving the vaccine.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Abnormal uterine bleeding, Haemorrhage, Thrombosis, Uterine operation
Clinical narrative: Abnormal uterine bleeding (clots), excessive hemorrhaging
Age: 61.0
Sex: F
Vaccine: UNK
Symptoms: Catarrh, Dyspnoea, Increased viscosity of upper respiratory secretion, Upper-airway cough syndrome
Clinical narrative: I started experiencing post nasal drip which I didn't have before covid jab. Then it got worse and it seems to be catarrh. When I bow my head down to wash my face, base of my throat is completely blocked and I can't breath. Mucus has become constant, uncoloured, non-smelly but thick mostly coming from throat. I have been prescribed a nasal spray, I sleep propped-up, drink a lot of water all throughout the day but it would not go away.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fall, Headache, Loss of consciousness, Syncope
Clinical narrative: Fainting 15 minutes after vaccine.  Consciousness loss, fall, extreme weakness for  several days. Extreme headache for over 2 weeks and lingering over 4 weeks.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine given beyound 30 days of refrigeration period; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine given beyound 30 days of refrigeration period) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine given beyound 30 days of refrigeration period). On 26-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine given beyound 30 days of refrigeration period) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medication was reported.  No Concomitant medication was reported.  No lab data was provided.   This case was linked to MOD-2021-313106 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram, Computerised tomogram head, Headache, Hypoaesthesia
Clinical narrative: NUMBNESS ON THE LEFT SIDE OF FACE; HEADACHE; This spontaneous report received from a patient via a company representative concerned a 44 year old male. The patient's weight was 290 pounds, and height was 66 inches. The patient's concurrent conditions included: rheumatoid arthritis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on JUL-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On 2021, the patient experienced numbness on the left side of face. On 2021, the patient experienced headache. Laboratory data (dates unspecified) included: Computerised tomography (NR: not provided) fine, and Head CT (NR: not provided) fine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from numbness on the left side of face, and headache. This report was non-serious.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenitis, Pain in extremity
Clinical narrative: Inflamed left lymph node; Arm pain; This is a spontaneous report from a contactable consumer, the patient. A 28-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 01Apr2021 at 11:00 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma, high blood pressure, and pituitary adenoma. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included losartan (MANUFACTURER UNKNOWN) for unknown indication on unknown date and unknown if ongoing. The patient previously received sulfamethoxazole; trimethoprim (SEPTRA) and experienced drug allergy. On 01Apr2021, the patient experienced inflamed left lymph node and arm pain. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events inflamed left lymph node and arm pain was resolved on an unknown date in Apr2021. No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; Improperly stored administered vaccines; This spontaneous report was received from a registered nurse and from vaccine coordinator and refers to a patient of unknown age and gender. The patient's concurrent conditions, historical conditions and concomitant medications were not reported.   On 09-SEP-2021, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # U010395 expiration date 01-APR-2023 (dose, route of administration and anatomical location were not reported) for prophylaxis (product storage error). The suspect vaccine was stored in a temperature from -10 degree Celsius (C) to 8 C for 5 hours and 10 minutes. There was previous temperature excursion - the vaccine was stored in a temperature from -10 C to 8 C for 8 hours and 41 minutes and for 3 hours and 35 minutes. No additional adverse events were reported (no adverse event).  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2109USA006537: US-009507513-2109USA006583: US-009507513-2109USA006584: US-009507513-2109USA006585: US-009507513-2109USA006586: US-009507513-2109USA006587: US-009507513-2109USA006588: US-009507513-2109USA006589: US-009507513-2109USA006590: US-009507513-2109USA006591: US-009507513-2109USA006592: US-009507513-2109USA006593: US-009507513-2109USA006594: US-009507513-2109USA006595: US-009507513-2109USA006596: US-009507513-2109USA006597: US-009507513-2110USA005066:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; Improperly stored administered vaccines; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, historical conditions and concomitant medications were not reported.   On 17-SEP-2021, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # T041687 expiration date 10-DEC-2022 (dose, route of administration and anatomical location were not reported) for prophylaxis (product storage error). The suspect vaccine was stored in a temperature from -10 degree Celsius (C) to 8 C for 5 hours and 10 minutes. There was previous temperature excursion - the vaccine was stored in a temperature from -10 C to 8 C for 8 hours and 41 minutes and for 3 hours and 35 minutes. No additional adverse events were reported (no adverse event).   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2109USA006537: US-009507513-2109USA006582: US-009507513-2109USA006584: US-009507513-2109USA006585: US-009507513-2109USA006586: US-009507513-2109USA006587: US-009507513-2109USA006588: US-009507513-2109USA006589: US-009507513-2109USA006590: US-009507513-2109USA006591: US-009507513-2109USA006592: US-009507513-2109USA006593: US-009507513-2109USA006594: US-009507513-2109USA006595: US-009507513-2109USA006596: US-009507513-2109USA006597: US-009507513-2110USA005066:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; Improperly stored administered vaccines; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, historical conditions and concomitant medications were not reported.   On 22-SEP-2021, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # T033166 expiration date 29-SEP-2022 (dose, route of administration and anatomical location were not reported) for prophylaxis (product storage error). The suspect vaccine was stored in a temperature from -10 degree Celsius (C) to 8 C for 5 hours and 10 minutes. There was previous temperature excursion - the vaccine was stored in a temperature from -10 C to 8 C for 8 hours and 41 minutes and for 3 hours and 35 minutes. No additional adverse events were reported (no adverse event).   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2109USA006537: US-009507513-2109USA006582: US-009507513-2109USA006583: US-009507513-2109USA006585: US-009507513-2109USA006586: US-009507513-2109USA006587: US-009507513-2109USA006588: US-009507513-2109USA006589: US-009507513-2109USA006590: US-009507513-2109USA006591: US-009507513-2109USA006592: US-009507513-2109USA006593: US-009507513-2109USA006594: US-009507513-2109USA006595: US-009507513-2109USA006596: US-009507513-2109USA006597: US-009507513-2110USA005066:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; Improperly stored administered vaccines; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, historical conditions and concomitant medications were not reported.   On 14-SEP-2021, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # T041687 expiration date 10-DEC-2022 (dose, route of administration and anatomical location were not reported) for prophylaxis (product storage error). The suspect vaccine was stored in a temperature from -10 degree Celsius (C) to 8 C for 5 hours and 10 minutes. There was previous temperature excursion - the vaccine was stored in a temperature from -10 C to 8 C for 8 hours and 41 minutes and for 3 hours and 35 minutes. No additional adverse events were reported (no adverse event).   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2109USA006537: US-009507513-2109USA006582: US-009507513-2109USA006583: US-009507513-2109USA006584: US-009507513-2109USA006586: US-009507513-2109USA006587: US-009507513-2109USA006588: US-009507513-2109USA006589: US-009507513-2109USA006590: US-009507513-2109USA006591: US-009507513-2109USA006592: US-009507513-2109USA006593: US-009507513-2109USA006594: US-009507513-2109USA006595: US-009507513-2109USA006596: US-009507513-2109USA006597: US-009507513-2110USA005066:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; Improperly stored administered vaccines; This spontaneous report was received from a registered nurse and from and refers to a patient of unknown age and gender. The patient's concurrent conditions, historical conditions and concomitant medications were not reported.   On 21-SEP-2021, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # T033166 expiration date 29-SEP-2022 (dose, route of administration and anatomical location were not reported) for prophylaxis (product storage error). The suspect vaccine was stored in a temperature from -10 degree Celsius (C) to 8 C for 5 hours and 10 minutes. There was previous temperature excursion - the vaccine was stored in a temperature from -10 C to 8 C for 8 hours and 41 minutes and for 3 hours and 35 minutes. No additional adverse events were reported (no adverse event).   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2109USA006537: US-009507513-2109USA006582: US-009507513-2109USA006583: US-009507513-2109USA006584: US-009507513-2109USA006585: US-009507513-2109USA006587: US-009507513-2109USA006588: US-009507513-2109USA006589: US-009507513-2109USA006590: US-009507513-2109USA006591: US-009507513-2109USA006592: US-009507513-2109USA006593: US-009507513-2109USA006594: US-009507513-2109USA006595: US-009507513-2109USA006596: US-009507513-2109USA006597: US-009507513-2110USA005066:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; Improperly stored administered vaccines; This spontaneous report was received from a registered nurse and and refers to a patient of unknown age and gender. The patient's concurrent conditions, historical conditions and concomitant medications were not reported.   On 14-SEP-2021, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # T041687 expiration date 10-DEC-2022 (dose, route of administration and anatomical location were not reported) for prophylaxis (product storage error). The suspect vaccine was stored in a temperature from -10 degree Celsius (C) to 8 C for 5 hours and 10 minutes. There was previous temperature excursion - the vaccine was stored in a temperature from -10 C to 8 C for 8 hours and 41 minutes and for 3 hours and 35 minutes. No additional adverse events were reported (no adverse event).   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2110USA005066: US-009507513-2109USA006582: US-009507513-2109USA006583: US-009507513-2109USA006584: US-009507513-2109USA006585: US-009507513-2109USA006586: US-009507513-2109USA006588: US-009507513-2109USA006589: US-009507513-2109USA006590: US-009507513-2109USA006591: US-009507513-2109USA006592: US-009507513-2109USA006593: US-009507513-2109USA006594: US-009507513-2109USA006595: US-009507513-2109USA006596: US-009507513-2109USA006597: US-009507513-2109USA006537:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; Improperly stored administered vaccines; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, historical conditions and concomitant medications were not reported.   On 13-SEP-2021, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # U010395 expiration date 01-APR-2023 (dose, route of administration and anatomical location were not reported) for prophylaxis (product storage error). The suspect vaccine was stored in a temperature from -10 degree Celsius (C) to 8 C for 5 hours and 10 minutes. There was previous temperature excursion - the vaccine was stored in a temperature from -10 C to 8 C for 8 hours and 41 minutes and for 3 hours and 35 minutes. No additional adverse events were reported (no adverse event).   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2110USA005066: US-009507513-2109USA006582: US-009507513-2109USA006583: US-009507513-2109USA006584: US-009507513-2109USA006585: US-009507513-2109USA006586: US-009507513-2109USA006587: US-009507513-2109USA006589: US-009507513-2109USA006590: US-009507513-2109USA006591: US-009507513-2109USA006592: US-009507513-2109USA006593: US-009507513-2109USA006594: US-009507513-2109USA006595: US-009507513-2109USA006596: US-009507513-2109USA006597: US-009507513-2109USA006537:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; Improperly stored administered vaccines; This spontaneous report was received from a registered nurse and from vaccine coordinator and refers to a patient of unknown age and gender. The patient's concurrent conditions, historical conditions and concomitant medications were not reported.   On 08-SEP-2021, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # T041687 expiration date 10-DEC-2022 (dose, route of administration and anatomical location were not reported) for prophylaxis (product storage error). The suspect vaccine was stored in a temperature from -10 degree Celsius (C) to 8 C for 5 hours and 10 minutes. There was previous temperature excursion - the vaccine was stored in a temperature from -10 C to 8 C for 8 hours and 41 minutes and for 3 hours and 35 minutes. No additional adverse events were reported (no adverse event).   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2110USA005066: US-009507513-2109USA006582: US-009507513-2109USA006583: US-009507513-2109USA006584: US-009507513-2109USA006585: US-009507513-2109USA006586: US-009507513-2109USA006587: US-009507513-2109USA006588: US-009507513-2109USA006590: US-009507513-2109USA006591: US-009507513-2109USA006592: US-009507513-2109USA006593: US-009507513-2109USA006594: US-009507513-2109USA006595: US-009507513-2109USA006596: US-009507513-2109USA006597: US-009507513-2109USA006537:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; Improperly stored administered vaccines; This spontaneous report was received from a registered nurse and from vaccine coordinator and refers to a patient of unknown age and gender. The patient's concurrent conditions, historical conditions and concomitant medications were not reported.   On 08-SEP-2021, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # T041687 expiration date 10-DEC-2022 (dose, route of administration and anatomical location were not reported) for prophylaxis (product storage error). The suspect vaccine was stored in a temperature from -10 degree Celsius (C) to 8 C for 5 hours and 10 minutes. There was previous temperature excursion - the vaccine was stored in a temperature from -10 C to 8 C for 8 hours and 41 minutes and for 3 hours and 35 minutes. No additional adverse events were reported (no adverse event).   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2110USA005066: US-009507513-2109USA006582: US-009507513-2109USA006583: US-009507513-2109USA006584: US-009507513-2109USA006585: US-009507513-2109USA006586: US-009507513-2109USA006587: US-009507513-2109USA006588: US-009507513-2109USA006589: US-009507513-2109USA006591: US-009507513-2109USA006592: US-009507513-2109USA006593: US-009507513-2109USA006594: US-009507513-2109USA006595: US-009507513-2109USA006596: US-009507513-2109USA006597: US-009507513-2109USA006537:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; Improperly stored administered vaccines; This spontaneous report was received from a registered nurse and from vaccine coordinator and refers to a patient of unknown age and gender. The patient's concurrent conditions, historical conditions and concomitant medications were not reported.   On 20-SEP-2021, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # T041687 expiration date 10-DEC-2022 (dose, route of administration and anatomical location were not reported) for prophylaxis (product storage error). The suspect vaccine was stored in a temperature from -10 degree Celsius (C) to 8 C for 5 hours and 10 minutes. There was previous temperature excursion - the vaccine was stored in a temperature from -10 C to 8 C for 8 hours and 41 minutes and for 3 hours and 35 minutes. No additional adverse events were reported (no adverse event).   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2110USA005066: US-009507513-2109USA006582: US-009507513-2109USA006583: US-009507513-2109USA006584: US-009507513-2109USA006585: US-009507513-2109USA006586: US-009507513-2109USA006587: US-009507513-2109USA006588: US-009507513-2109USA006589: US-009507513-2109USA006590: US-009507513-2109USA006592: US-009507513-2109USA006593: US-009507513-2109USA006594: US-009507513-2109USA006595: US-009507513-2109USA006596: US-009507513-2109USA006597: US-009507513-2109USA006537:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; Improperly stored administered vaccines; This spontaneous report was received from a registered nurse and from vaccine coordinator and refers to a patient of unknown age and gender. The patient's concurrent conditions, historical conditions and concomitant medications were not reported.   On 14-SEP-2021, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # T041687 expiration date 10-DEC-2022 (dose, route of administration and anatomical location were not reported) for prophylaxis (product storage error). The suspect vaccine was stored in a temperature from -10 degree Celsius (C) to 8 C for 5 hours and 10 minutes. There was previous temperature excursion - the vaccine was stored in a temperature from -10 C to 8 C for 8 hours and 41 minutes and for 3 hours and 35 minutes. No additional adverse events were reported (no adverse event).   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2110USA005066: US-009507513-2109USA006582: US-009507513-2109USA006583: US-009507513-2109USA006584: US-009507513-2109USA006585: US-009507513-2109USA006586: US-009507513-2109USA006587: US-009507513-2109USA006588: US-009507513-2109USA006589: US-009507513-2109USA006590: US-009507513-2109USA006591: US-009507513-2109USA006593: US-009507513-2109USA006594: US-009507513-2109USA006595: US-009507513-2109USA006596: US-009507513-2109USA006597: US-009507513-2109USA006537:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; Improperly stored administered vaccines; This spontaneous report was received from a registered nurse and from vaccine coordinator and refers to a patient of unknown age and gender. The patient's concurrent conditions, historical conditions and concomitant medications were not reported.   On 14-SEP-2021, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # U010395 expiration date 01-APR-2023 (dose, route of administration and anatomical location were not reported) for prophylaxis (product storage error). The suspect vaccine was stored in a temperature from -10 degree Celsius (C) to 8 C for 5 hours and 10 minutes. There was previous temperature excursion - the vaccine was stored in a temperature from -10 C to 8 C for 8 hours and 41 minutes and for 3 hours and 35 minutes. No additional adverse events were reported (no adverse event).   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2110USA005066: US-009507513-2109USA006582: US-009507513-2109USA006583: US-009507513-2109USA006584: US-009507513-2109USA006585: US-009507513-2109USA006586: US-009507513-2109USA006587: US-009507513-2109USA006588: US-009507513-2109USA006589: US-009507513-2109USA006590: US-009507513-2109USA006591: US-009507513-2109USA006592: US-009507513-2109USA006594: US-009507513-2109USA006595: US-009507513-2109USA006596: US-009507513-2109USA006597: US-009507513-2109USA006537:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; Improperly stored administered vaccines; This spontaneous report was received from a registered nurse and from vaccine coordinator and refers to a patient of unknown age and gender. The patient's concurrent conditions, historical conditions and concomitant medications were not reported.   On 14-SEP-2021, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # T041687 expiration date 10-DEC-2022 (dose, route of administration and anatomical location were not reported) for prophylaxis (product storage error). The suspect vaccine was stored in a temperature from -10 degree Celsius (C) to 8 C for 5 hours and 10 minutes. There was previous temperature excursion - the vaccine was stored in a temperature from -10 C to 8 C for 8 hours and 41 minutes and for 3 hours and 35 minutes. No additional adverse events were reported (no adverse event).   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2110USA005066: US-009507513-2109USA006582: US-009507513-2109USA006583: US-009507513-2109USA006584: US-009507513-2109USA006585: US-009507513-2109USA006586: US-009507513-2109USA006587: US-009507513-2109USA006588: US-009507513-2109USA006589: US-009507513-2109USA006590: US-009507513-2109USA006591: US-009507513-2109USA006592: US-009507513-2109USA006593: US-009507513-2109USA006595: US-009507513-2109USA006596: US-009507513-2109USA006597: US-009507513-2109USA006537:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; Improperly stored administered vaccines; This spontaneous report was received from a registered nurse and from vaccine coordinator and refers to a patient of unknown age and gender. The patient's concurrent conditions, historical conditions and concomitant medications were not reported.   On 20-SEP-2021, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # U010395 expiration date 01-APR-2023 (dose, route of administration and anatomical location were not reported) for prophylaxis (product storage error). The suspect vaccine was stored in a temperature from -10 degree Celsius (C) to 8 C for 5 hours and 10 minutes. There was previous temperature excursion - the vaccine was stored in a temperature from -10 C to 8 C for 8 hours and 41 minutes and for 3 hours and 35 minutes. No additional adverse events were reported (no adverse event).   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2110USA005066: US-009507513-2109USA006582: US-009507513-2109USA006583: US-009507513-2109USA006584: US-009507513-2109USA006585: US-009507513-2109USA006586: US-009507513-2109USA006587: US-009507513-2109USA006588: US-009507513-2109USA006589: US-009507513-2109USA006590: US-009507513-2109USA006591: US-009507513-2109USA006592: US-009507513-2109USA006593: US-009507513-2109USA006594: US-009507513-2109USA006596: US-009507513-2109USA006597: US-009507513-2109USA006537:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; Improperly stored administered vaccines; This spontaneous report was received from a registered nurse and from vaccine coordinator and refers to a patient of unknown age and gender. The patient's concurrent conditions, historical conditions and concomitant medications were not reported.   On 22-SEP-2021, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # T033166 expiration date 29-SEP-2022 (dose, route of administration and anatomical location were not reported) for prophylaxis (product storage error). The suspect vaccine was stored in a temperature from -10 degree Celsius (C) to 8 C for 5 hours and 10 minutes. There was previous temperature excursion - the vaccine was stored in a temperature from -10 C to 8 C for 8 hours and 41 minutes and for 3 hours and 35 minutes. No additional adverse events were reported (no adverse event).   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2110USA005066: US-009507513-2109USA006582: US-009507513-2109USA006583: US-009507513-2109USA006584: US-009507513-2109USA006585: US-009507513-2109USA006586: US-009507513-2109USA006587: US-009507513-2109USA006588: US-009507513-2109USA006589: US-009507513-2109USA006590: US-009507513-2109USA006591: US-009507513-2109USA006592: US-009507513-2109USA006593: US-009507513-2109USA006594: US-009507513-2109USA006595: US-009507513-2109USA006597: US-009507513-2109USA006537:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; Improperly stored administered vaccines; This spontaneous report was received from a registered nurse and from vaccine coordinator and refers to a patient of unknown age and gender. The patient's concurrent conditions, historical conditions and concomitant medications were not reported.   On 14-SEP-2021, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot #T041687 expiration date 10-DEC-2022 (dose, route of administration and anatomical location were not reported) for prophylaxis (product storage error). The suspect vaccine was stored in a temperature from -10 degree Celsius (C) to 8 C for 5 hours and 10 minutes. There was previous temperature excursion - the vaccine was stored in a temperature from -10 C to 8 C for 8 hours and 41 minutes and for 3 hours and 35 minutes. No additional adverse events were reported (no adverse event).   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2110USA005066: US-009507513-2109USA006582: US-009507513-2109USA006583: US-009507513-2109USA006584: US-009507513-2109USA006585: US-009507513-2109USA006586: US-009507513-2109USA006587: US-009507513-2109USA006588: US-009507513-2109USA006589: US-009507513-2109USA006590: US-009507513-2109USA006591: US-009507513-2109USA006592: US-009507513-2109USA006593: US-009507513-2109USA006594: US-009507513-2109USA006595: US-009507513-2109USA006596: US-009507513-2109USA006537:
Sex: M
Vaccine: PPV
Symptoms: Poor quality product administered, Syringe issue
Clinical narrative: One of the two finger flanges broke off; The vaccine was still administered to the patient as the finger flnage breaking off was the only defect.; This spontaneous report was received from a Licensed Practical Nurse, referring to a 76 year old male patient. Information regarding the patient's pertinent medical history, concurrent conditions and concomitant therapies was not provided. The patient had no known allergies.      On 28-SEP-2021, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), with lot # U003306 has been verified to be a valid lot number and expiration date, on a dose of 0.5 milliliter, by intramuscular route in the right arm, as it was age appropriate.   It was reported that, on the same date, while the physician was administering pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), one of the two finger flakes broke off (syringe issue and poor quality product administered). It was reported that the physician, cut his finger and it required a band aid (captured in MARRS # 2110USA004833). It was also reported that, the vaccine was still administered and that the patient did not even know what happened.  The vaccine was not able to be retrieved as the physician disposed the pieces into sharp container.  This is one of two cases received by the same reporter. ; Sender's Comments:  US-009507513-2110USA004833:
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Underdose
Clinical narrative: No additional AEs; pediatrics dose of VAQTA was administered to a 20 years old patient; This spontaneous report was received from a medical assistance and refers to a 20 year old patient of unknown gender. The patient's pertinent medical history, drug reactions or allergies, and concomitant therapies were not reported.  On 06-OCT-2021, the 20-year-old patient was vaccinated with a pediatric dose of hepatitis a vaccine, inactivated (VAQTA), 0.5 milliliter, intramuscularly (IM), lot number reported as T03304 with expiration date 02-APR-2022 for prophylaxis (anatomical location was not reported) (product use issue). No additional adverse events (AE) or product quality complain reported.    Lot number T03304 is an invalid lot number for hepatitis a vaccine, inactivated (VAQTA). Lot number T03304 does not match any Company product as confirmed by Lot Verification team.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash
Clinical narrative: painful shingles; Information has been received from a lawyer referring to a female (also reported as male, inconsistent information) patient of unknown age regarding a case in litigation. Information about concurrent condition, history condition and concomitant medication was not reported. On or around 01-NOV-2018, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot# and expiration date unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Subsequent to the zoster vaccine live (ZOSTAVAX) vaccine being administered, the patient developed an outbreak of skin rash on her upper right thigh on 28-NOV-2018. On the same date, the patient was diagnosed with painful shingles by her physician. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms had resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of wrongful conduct, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The patient also had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. All damage proximately caused by the aforementioned characteristics of the zoster vaccine live (ZOSTAVAX) product that rendered the product unreasonably dangerous, arose from the reasonably anticipated use of the product by the patient. The outcome of painful shingles was considered as not recovered and causal relationship was assessed as related.  The event painful shingles was considered as disability by the lawyer.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE details available; a patient was administered an expired dose of PNEUMOVAX 23; This spontaneous report was received from a  medical assistance referring to a patient of unknown age and gender. Concomitant medication, pertinent medical history and drug reaction or allergies were not reported.    On 14-OCT-2021, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (strength and route were not reported; lot # T021329, expiration date: 03-OCT-2021) for prophylaxis (expired product administered).     No prior temperature excursion. No additional AE details available (no adverse event).