chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effects; the administration of one dose of an expired vaccine, GARDASIL 9 (Lot # R024264 / Expiration Date:10/29/2019) to one patient on 11/5/2019; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's concurrent condition, pertinent medical history, concomitant therapy and drug reactions/allergies were not reported.      On 05-NOV-2019, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 0.5 ml (strength and route of administration not reported; lot # R024264 and expiration date 29-OCT-2019) for prophylaxis (expired product administered). No adverse effects was reported for the patient by the nurse.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse effect; the patient was administered a properly store but expired dose of PROQUAD; This spontaneous report was received from an office manager regarding a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications and drug allergies/reaction were not provided. On 06-NOV-2019, the patient was vaccinated with a properly stored but expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) injection lot# R011216, expiration date:15-OCT-2019 (dose number, route of administration and anatomical location were not provided) for prophylaxis (expired product administered). No adverse effects reported. No product quality complaints (PQC) were involved.
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; received improperly stored VARlVAX via the intramuscular route on 9/10/2019; received improperly stored VARlVAX via the intramuscular route on 9/10/2019; Information has been received from a medical assistant referring to a male patient of unknown age. The patient's pertinent medical history, drug reactions/allergies and concurrent condition were not provided. Concomitant therapies included sterile diluent. Sterile diluent was stored properly.  On 10-SEP-2019 the patient received improperly stored varicella virus vaccine live (oka/merck) (VARIVAX)(therapy type: digital data logger; batch/lot number R018144 and expiration date 25-JUN-2020; strength and dose were not provided) intramuscularly for prophylaxis (product storage error and incorrect route of product administration). The administered doses experienced a temperature excursion ranged from 6 degree Fahrenheit to 14 degree Fahrenheit for 8.75 hours (average 8.7 degree Fahrenheit). No previous excursions were reported. The temperature excursions were detected by a data logger. No adverse effects were reported.
Sex: U
Vaccine: MMRV, MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: Two doses of improperly stored vaccine were administered to two separate uspecified patients; The total volume used of the sterile diluent used to reconstitute the vaccine was 0.7 ml; No adverse effects reported; This spontaneous report has been received from a medical assistant regarding a 12-month-old patient of unknown gender. The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medication were not reported.  On an unknown date, the patient was vaccinated with an improperly stored dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) 0.5 milliliter, Lot number S007069, expiration date reported as 06-SEP-2020, for prophylaxis (strength and anatomical location not reported) which were reconstituted with properly stored sterile diluent (DILUENT MRK) lot number R014176 and expiration date reported as 23-JAN-2021. The total volume of sterile diluent used to reconstitute Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) was reported to be 0.7 ml (Product preparation issue).   The vaccine Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) was stored at a temperature range of 15°F for the time frame of 40 minutes. There was no previous temperature excursion and the call was because of a data logger.  No adverse effects were reported.  This is one of two reports received from the same reporter. ; Sender's Comments:  US-009507513-1911USA009979:
Sex: U
Vaccine: MMRV, MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: Two doses of improperly stored vaccine were administered to two separate uspecified patients; The total volume used of the sterile diluent used to reconstitute the vaccine was 0.7 ml; No adverse effects reported; This spontaneous report has been received from a medical assistant regarding a 12-month-old patient of unknown gender. The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medication were not reported.  On an unknown date, the patient was vaccinated with an improperly stored dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) 0.5 milliliter, Lot number S007069, expiration date reported as 06-SEP-2020, for prophylaxis (strength and anatomical location not reported) which were reconstituted with properly stored sterile diluent (DILUENT MRK) lot number R014176 and expiration date reported as 23-JAN-2021. The total volume of sterile diluent used to reconstitute Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) was reported to be 0.7 ml (Product preparation issue).   The vaccine Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) was stored at a temperature range of 15°F for the time frame of 40 minutes. There was no previous temperature excursion and the call was because of a data logger.  No adverse effects were reported.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-1911USA004147:
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia
Clinical narrative: loss of vision; Postherpetic neuralgia (PHN); Shingles (herpes zoster); This spontaneous report was received on 15-NOV-2019, from a lawyer via a Plaintiff Fact Sheet regarding a case in litigation and refers to an approximately 62-year-old female patient (pt). Pt's concurrent conditions, concomitant medications and medical history were not reported. On 08-OCT-2014, pt was vaccinated with zoster vaccine live (ZOSTAVAX) (exact dose, frequency, site and route of administration, lot# and expiration date were not reported) for prophylaxis. Pt claimed that she suffered following physical injuries caused by zoster vaccine live (ZOSTAVAX): shingles (herpes zoster), post herpetic neuralgia (PHN) and loss of vision. On 01-JAN-2014, pt was diagnosed with loss of vision (conflicting information - onset date of that event was reported as prior to vaccination with zoster vaccine live (ZOSTAVAX)). On an unknown date in 2015, pt was diagnosed with shingles. On an unknown date, pt was diagnosed with PHN. Pt was treated by a physician in 2015. The outcome of the events was unknown. The relatedness between the event and zoster vaccine live (ZOSTAVAX) was reported as related.  Information was received on 15-NOV-2019, from medical records. Pt had no known allergic reaction to bakers yeast, diptheria toxoid, gelatin, latex or sensitivity to latex, neomycin, polymyxin B, streptomycin, tetanus toxoid and thimerlsol. On 08-OCT-2014, pt was vaccinated with zoster vaccine live (ZOSTAVAX) subcutaneously.  Upon internal review, the events of loss of vision was determined to be medically significant.  All available medical records will be provided upon request.
Sex: F
Vaccine: VARZOS
Symptoms: Bronchitis, Chest discomfort, Chronic obstructive pulmonary disease, Condition aggravated, Cough
Clinical narrative: bilateral pneumonia; COPD exacerbation; bronchitis; This initial spontaneous report was received from three lawyers, regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications.  On or around 06-OCT-2017, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster).  On an unspecified date, shortly after vaccination, the patient suffered a severe persistent cough associated with chest discomfort, right rib pain, headache and shortness of breath. The patient was ultimately hospitalized and diagnosed with having bilateral pneumonia, chronic obstructive pulmonary disease exacerbation and bronchitis. The outcome of the events was not reported.  The reporters considered the events to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review, the event pneumonia was determined to be medically significant.
Sex: F
Vaccine: VARZOS
Symptoms: Dyspnoea, Headache, Musculoskeletal chest pain, Pneumonia
Clinical narrative: bilateral pneumonia; COPD exacerbation; bronchitis; This initial spontaneous report was received from three lawyers, regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications.  On or around 06-OCT-2017, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster).  On an unspecified date, shortly after vaccination, the patient suffered a severe persistent cough associated with chest discomfort, right rib pain, headache and shortness of breath. The patient was ultimately hospitalized and diagnosed with having bilateral pneumonia, chronic obstructive pulmonary disease exacerbation and bronchitis. The outcome of the events was not reported.  The reporters considered the events to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review, the event pneumonia was determined to be medically significant.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding the patient's historical conditions, previous drug reactions, allergies, concurrent conditions or concomitant medications.  On an unspecified date in 2012, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) for for the long-term prevention of herpes zoster or shingles (prophylaxis) (dose, route of administration, lot number and expiration date were not reported).         On an unknown date, the patient experienced herpes zoster, which required hospitalization and the patient received treatment for the event. The lawyer specified that the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; significant medical and related expenses as a result of these injuries, including but not limited to costs for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages.  The outcome of herpes zoster is unknown. The reporter considered herpes zoster to be related to Zoster Vaccine Live (ZOSTAVAX).
Sex: M
Vaccine: VARZOS
Symptoms: Basal ganglia haematoma, Ischaemic stroke
Clinical narrative: acute right basal ganglia hematoma with extension to the intraventricular area; right caudate nucleus and right corona radiata ischemic stroke; This initial spontaneous report was received from a lawyer regarding a case in litigation referring to a male patient of unknown age. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On or about 03-MAR-2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot #, expiration date, dosage and route of administration were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiveing zoster vaccine live (ZOSTAVAX), the patient suffered  acute right basal ganglia hematoma with extension to the interventricular area, right caudate nucleus and right corona radiata ischemic stroke requiring hospitalization. As a direct and proximate result, 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 his condition. 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.   Upon internal review, acute right basal ganglia hematoma with extension to the interventricular area, right caudate nucleus and right corona radiata ischemic stroke were considered medically significant.    The events were considered to be disabling due to the severe, permanent and incurable injuries.
Sex: M
Vaccine: VARZOS
Symptoms: Pleural effusion, Pneumonia
Clinical narrative: pneumonia with pleural effusion; pneumonia with pleural effusion; This initial spontaneous report was received from a lawyer regarding a case in litigation referring to a male patient of unknown age. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On or about 18-NOV-2016, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot #, expiration date, dosage and route of administration were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Less than one (1) month (approximately in 2016) after receiveing zoster vaccine live (ZOSTAVAX), the patient was hospitalized and diagnosed with pneumonia with pleural effusion. As a direct and proximate result, 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 his condition. 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.   Upon internal review, pneumonia was considered to be medically significant.    Both events were considered to be disabling due to the severe, permanent and incurable injuries.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: administered improperly stored vaccine; No advesre effect; This spontaneous report as received from a other health professional refers to unspecified patients of unknown age and gender. The patients pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant therapies were not reported.  On an unknown dates, the patients were vaccinated with improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (strength, dose, route of administration were not reported, lot # S008729 has been verified to be a valid lot number for (haemophilus b conjugate vaccine (meningococcal protein conjugate)), expiration date reported as 21-JAN-2020) for prophylaxis (product storage error). No additional adverse effects were reported. It was reported that the vaccine was exposed to a temperature of 1.0 degree Celsius for a time frame 3 hours 30 minutes. There was no previous temperature excursion reported. Data logger was involved. No product quality complaint (PQC) was associated with this report. The outcome of product storage error and no adverse event were  unknown. Causality was not provided.  This is a non-valid case due to lack of patient identifiers.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered
Clinical narrative: the patient was inadvertently administered a dose of PNEUMOVAX 23 that was expired.; This spontaneous report was received from a physician assistant referring to a patient of unknown age and unknown gender. Information about pertinent medical history, concurrent conditions, concomitant medication and drug reactions/allergies was not provided.   On 20-NOV-2019, the patient was inadvertently a dose of expired vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (lot # R006465 with expiration date 24-OCT-2019; strength, dose detail and route were not reported) for prophylaxis (expired vaccine used). The outcome of the event was unknown. The causality assessment of the event was not provided.
Sex: U
Vaccine: HEP
Symptoms: Product storage error
Clinical narrative: improperly stored vaccine administered; This spontaneous report was received from a Registered Nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, drug reactions and allergies were unknown.       On 17-NOV-2019, the patient received an improperly stored dose (product storage error) of hepatitis b vaccine thimerosal free (recombinant) (RECOMBIVAX HB) injection, 5 microgram (mcg) per 0.5 milliliter (ml), lot # R021372 and expiry date 25-MAY-2021 reported, for prophylaxis (strength, anatomical location and route not reported). The time frame for multiple temperature excursions was 25 Fahrenheit (F) for 6 hours 28 minutes and 55F temperature for seven hours. It was reported that there was no previous temperature excursions done. Data logger was involved. The outcome of product storage error was unknown. No product quality complaint involved.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, UNK
Symptoms: Abdominal pain, Balance disorder, Headache, Limb discomfort, Muscular weakness
Clinical narrative: the patient had a headache and abdominal pain; the patient had a headache and abdominal pain; the patient had "unsteadiness; the patient vomited 4 times; left arm felt heavy, weak and sore; left arm felt heavy, weak and sore; left arm felt heavy, weak and sore/arm being sore; This spontaneous report was received from a registered nurse referring to a 11 year old male patient. The patient had no concomitant medication, pertinent medical history or drug reactions/allergies.  On 19-NOV-2019, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9)(dose was unknown; lot # 1621929, expiration date 06-DEC-2021, via intramuscular in the left arm as routine vaccination (prophylaxis). At the same visit, the patient was also administered a dose of diphtheria toxoid (+) pertussis acellular vaccine (unspecified)(+) tetanus toxoid and meningococcal acyw conj vaccine (dip toxoid)(MENACTRA) (dose, route, lot#, expiration date were unknown) for prophylaxis.      On 19-NOV-2019, 30 minutes after having the injections the patient had unsteadiness for 5 minutes and then 6 hours after the injection the patient vomited 4 times. On the same day, the patient's left arm felt heavy, weak and sore. On 20-NOV-2019, the patient had a headache and abdominal pain. The patient's mother called physician office, but no treatment was given for the events. The nurse reported that all of the patient's symptoms have resolved except for the patient's arm being sore. The causality assessment was not provided.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, UNK
Symptoms: Pain in extremity, Vomiting
Clinical narrative: the patient had a headache and abdominal pain; the patient had a headache and abdominal pain; the patient had "unsteadiness; the patient vomited 4 times; left arm felt heavy, weak and sore; left arm felt heavy, weak and sore; left arm felt heavy, weak and sore/arm being sore; This spontaneous report was received from a registered nurse referring to a 11 year old male patient. The patient had no concomitant medication, pertinent medical history or drug reactions/allergies.  On 19-NOV-2019, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9)(dose was unknown; lot # 1621929, expiration date 06-DEC-2021, via intramuscular in the left arm as routine vaccination (prophylaxis). At the same visit, the patient was also administered a dose of diphtheria toxoid (+) pertussis acellular vaccine (unspecified)(+) tetanus toxoid and meningococcal acyw conj vaccine (dip toxoid)(MENACTRA) (dose, route, lot#, expiration date were unknown) for prophylaxis.      On 19-NOV-2019, 30 minutes after having the injections the patient had unsteadiness for 5 minutes and then 6 hours after the injection the patient vomited 4 times. On the same day, the patient's left arm felt heavy, weak and sore. On 20-NOV-2019, the patient had a headache and abdominal pain. The patient's mother called physician office, but no treatment was given for the events. The nurse reported that all of the patient's symptoms have resolved except for the patient's arm being sore. The causality assessment was not provided.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain
Clinical narrative: Injection site pain which has become progressively worse; This spontaneous report was received from a registered nurse referring to a 66 year old female patient. The patient did not had any pertinent medical history, concomitant therapy, drug reaction or allergies. On 13-NOV-2019, the patient was vaccinated with a pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23), injection via intramuscular route in the left deltoid, lot # S027047 with expiry date 13-MAY-20121 (strength and frequency were unknown) for prophylaxis. On the same day, few hours latter, the patient experienced injection site pain which had became progressively worse. Patient did not seek medical attention but self medicated with acetaminophen (TYLENOL). No lab tests performed. No significant disability, incapacity, intervention to prevent serious criteria or overdose was reported. The outcome of injection site pain was reported as not recovered. Causality assessment was not provided by the reporter.
Sex: M
Vaccine: MMRV, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect; received improperly stored vaccine; This spontaneous report was received from a nurse concerning a 4-year-old male patient. The patient's medical history, concurrent conditions, drug allergies/reactions and concomitant medications were not reported. On 14-NOV-2019, the patient was vaccinated with an improperly stored dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) lot # S012470 with expiration date 20-OCT-2020 (strength, dose, schedule, anatomical location and route of administration were not reported) for prophylaxis, which was used with the sterile diluent. No adverse effects were reported. No additional information was provided. The storage temperatures of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) were reported as between 6 to 14 (°F) (7.2 F) for a time frame of 1 hour and 10 minutes. There was no previous temperature excursion. There was an involvement of data logger. No product quality complaints (PQC) were involved.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX); This spontaneous report was received from a registered nurse referring to a patient of an unknown age and gender.   The patient's medical history, concurrent conditions, concomitant medications, past drugs and allergies were unknown.  On 20-NOV-2019, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) (strength, dose, frequency and route were unknown) (lot # S019581 and expiration date: 25-JUN-2021) for prophylaxis. No adverse effects were reported. The temperature was minus 0.2 Celsius for 2 hours and 40 minutes. The previous temperature excursion was at 4.25 Celsius for 2 hours 40 minutes. This call was because of digital data logger.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; received improperly stored VARIVAX; This spontaneous report was received from lead medical assistant refers to a 12 month old patient of unknown gender. The patient's medical history, concurrent conditions, historical drugs and drug reactions/allergies were not reported. Concomitant medication included sterile diluent. On 10-APR-2019, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) lot # R023503 and expiry date 16-AUG-2020 (strength, dose, unit, route, anatomical location were not reported) for prophylaxis (product storage error). The vaccine was reconstituted with properly stored sterile diluent. The administered doses of the vaccines experienced temperature excursion from above 6 degree Fahrenheit (F) to 14 degree F (7.5 degree) for five minutes. No previous temperature excursion was reported. The call was due to digital data logger. No adverse effects were reported. No product quality complaint (PQC) was involved.  This is one of several reports received from the same reporter.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; received improperly stored VARIVAX; This spontaneous report was received from lead medical assistant refers to a 12 month old patient of unknown gender. The patient's medical history, concurrent conditions, historical drugs and drug reactions/allergies were not reported. Concomitant medication included sterile diluent. On 12-APR-2019, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) lot # R011805 and expiry date 23-APR-2020 (strength, dose, unit, route, anatomical location were not reported) for prophylaxis (product storage error). The vaccine was reconstituted with properly stored sterile diluent. The administered doses of the vaccines experienced temperature excursion from above 6 degree Fahrenheit (F) to 14 degree F (7.5 degree) for five minutes. No previous temperature excursion was reported. The call was due to digital data logger. No adverse effects were reported. No product quality complaint (PQC) was involved.  This is one of several reports received from the same reporter.
Age: 1.25
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; received improperly stored VARIVAX; This spontaneous report was received from lead medical assistant refers to a 15 month old patient of unknown gender. The patient's medical history, concurrent conditions, historical drugs and drug reactions/allergies were not reported. Concomitant medication included sterile diluent. On 18-APR-2019, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) lot # R023503 and expiry date 16-AUG-2020 (strength, dose, unit, route, anatomical location were not reported) for prophylaxis (product storage error). The vaccine was reconstituted with properly stored sterile diluent. The administered doses of the vaccines experienced temperature excursion from above 6 degree Fahrenheit (F) to 14 degree F (7.5 degree) for five minutes. No previous temperature excursion was reported. The call was due to digital data logger. No adverse effects were reported. No product quality complaint (PQC) was involved.  This is one of several reports received from the same reporter.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; received improperly stored VARIVAX; This spontaneous report was received from lead medical assistant refers to a 12 month old patient of unknown gender. The patient's medical history, concurrent conditions, historical drugs and drug reactions/allergies were not reported. Concomitant medication included sterile diluent. On 22-APR-2019, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) lot # R011805 and expiry date 23-APR-2020 (strength, dose, unit, route, anatomical location were not reported) for prophylaxis (product storage error). The vaccine was reconstituted with properly stored sterile diluent. The administered doses of the vaccines experienced temperature excursion from above 6 degree Fahrenheit (F) to 14 degree F (7.5 degree) for five minutes. No previous temperature excursion was reported. The call was due to digital data logger. No adverse effects were reported. No product quality complaint (PQC) was involved.  This is one of several reports received from the same reporter.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; received improperly stored VARIVAX; This spontaneous report was received from lead medical assistant refers to a 12 month old patient of unknown gender. The patient's medical history, concurrent conditions, historical drugs and drug reactions/allergies were not reported. Concomitant medication included sterile diluent. On 24-APR-2019, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) lot # R023503 and expiry date 16-AUG-2020 (strength, dose, unit, route, anatomical location were not reported) for prophylaxis (product storage error). The vaccine was reconstituted with properly stored sterile diluent. The administered doses of the vaccines experienced temperature excursion from above 6 degree Fahrenheit (F) to 14 degree F (7.5 degree) for five minutes. No previous temperature excursion was reported. The call was due to digital data logger. No adverse effects were reported. No product quality complaint (PQC) was involved.  This is one of several reports received from the same reporter.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; received improperly stored VARIVAX; This spontaneous report was received from lead medical assistant refers to a 4 year old patient of unknown gender. The patient's medical history, concurrent conditions, historical drugs and drug reactions/allergies were not reported. Concomitant medication included sterile diluent. On 02-APR-2019, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) lot # R023503 and expiry date 16-AUG-2020 (strength, dose, unit, route, anatomical location were not reported) for prophylaxis (product storage error). The vaccine was reconstituted with properly stored sterile diluent. The administered doses of the vaccines experienced temperature excursion from above 6 degree Fahrenheit (F) to 14 degree F (7.5 degree F) for five minutes. No previous temperature excursion was reported. The call was due to digital data logger. No adverse effects were reported. No product quality complaint (PQC) was involved.  This is one of several reports received from the same reporter.
Age: 3.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; received improperly stored VARIVAX; This spontaneous report was received from lead medical assistant refers to a 3 year old patient of unknown gender. The patient's medical history, concurrent conditions, historical drugs and drug reactions/allergies were not reported. Concomitant medication included sterile diluent. On 03-APR-2019, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) lot # R023503 and expiry date 16-AUG-2020 (strength, dose, unit, route, anatomical location were not reported) for prophylaxis (product storage error). The vaccine was reconstituted with properly stored sterile diluent. The administered doses of the vaccines experienced temperature excursion from above 6 degree Fahrenheit (F) to 14 degree F (7.5 degree F) for five minutes. No previous temperature excursion was reported. The call was due to digital data logger. No adverse effects were reported. No product quality complaint (PQC) was involved.  This is one of several reports received from the same reporter.
Age: 5.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; received improperly stored VARIVAX; This spontaneous report was received from lead medical assistant refers to a 5 year old patient of unknown gender. The patient's medical history, concurrent conditions, historical drugs and drug reactions/allergies were not reported. Concomitant medication included sterile diluent. On 11-APR-2019, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) lot # R023503 and expiry date 16-AUG-2020 (strength, dose, unit, route, anatomical location were not reported) for prophylaxis (product storage error). The vaccine was reconstituted with properly stored sterile diluent. The administered doses of the vaccines experienced temperature excursion from above 6 degree Fahrenheit (F) to 14 degree F (7.5 degree F) for five minutes. No previous temperature excursion was reported. The call was due to digital data logger. No adverse effects were reported. No product quality complaint (PQC) was involved.  This is one of several reports received from the same reporter.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; received improperly stored VARIVAX; This spontaneous report was received from lead medical assistant refers to a 4 year old patient of unknown gender. The patient's medical history, concurrent conditions, historical drugs and drug reactions/allergies were not reported. Concomitant medication included sterile diluent. On 17-APR-2019, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) lot # R011805 and expiry date 23-APR-2020 (strength, dose, unit, route, anatomical location were not reported) for prophylaxis (product storage error). The vaccine was reconstituted with properly stored sterile diluent. The administered doses of the vaccines experienced temperature excursion from above 6 degree Fahrenheit (F) to 14 degree F (7.5 degree F) for five minutes. No previous temperature excursion was reported. The call was due to digital data logger. No adverse effects were reported. No product quality complaint (PQC) was involved.  This is one of several reports received from the same reporter.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; received improperly stored VARIVAX; This spontaneous report was received from lead medical assistant refers to a 4 year old patient of unknown gender. The patient's medical history, concurrent conditions, historical drugs and drug reactions/allergies were not reported. Concomitant medication included sterile diluent. On 19-APR-2019, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) lot # R023503 and expiry date 16-AUG-2020 (strength, dose, unit, route, anatomical location were not reported) for prophylaxis (product storage error). The vaccine was reconstituted with properly stored sterile diluent. The administered doses of the vaccines experienced temperature excursion from above 6 degree Fahrenheit (F) to 14 degree F (7.5 degree F) for five minutes. No previous temperature excursion was reported. The call was due to digital data logger. No adverse effects were reported. No product quality complaint (PQC) was involved.  This is one of several reports received from the same reporter.
Age: 3.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; received improperly stored VARIVAX; This spontaneous report was received from lead medical assistant refers to a 3 year old patient of unknown gender. The patient's medical history, concurrent conditions, historical drugs and drug reactions/allergies were not reported. Concomitant medication included sterile diluent. On 22-APR-2019, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) lot # R023503 and expiry date 16-AUG-2020 (strength, dose, unit, route, anatomical location were not reported) for prophylaxis (product storage error). The vaccine was reconstituted with properly stored sterile diluent. The administered doses of the vaccines experienced temperature excursion from above 6 degree Fahrenheit (F) to 14 degree F (7.5 degree F) for five minutes. No previous temperature excursion was reported. The call was due to digital data logger. No adverse effects were reported. No product quality complaint (PQC) was involved.  This is one of several reports received from the same reporter.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: NO ADVERSE EFFECT; improperly stored administeerd; This spontaneous report was received from a medical assistant regarding a patient of unknown age and gender. The patients' concurrent condition, pertinent medical history and drug reactions/allergies were unknown. The patients' concomitant therapy included sterile diluent. On 15-APR-2019, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (therapy type digital data logger) (dose and anatomical location were unknown, lot # R020678 and expiration date: 15-JAN-2020) as prophylaxis (product storage error). No adverse effects were reported. The administered dose of the vaccine experienced a temperature excursion of 15-degree Fahrenheit (°F) to 46 (°F) (reported as (32.57 (°F)) for 22 hours, as recorded by a data logger. The vaccine had no previous temperature excursion. There was no product quality complaint associated with this report.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effect; improperly stored vaccine administered; This spontaneous report was received from a medical assistant regarding a patient of unknown gender and age. Information on pertinent medical history and drug reactions/allergies were not reported. On 30-APR-2019, the patient was vaccinated with improperly stored Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), lot# R020678 with expiry date of 15-JAN-2020, for prophylaxis (dose, route of administration was not reported) (Product storage error). The patient had received properly stored Merck sterile diluent. No additional adverse effects were reported. Temperature was reported as (32.57 F) 15 degrees Fahrenheit to 45 degrees Fahrenheit. Time frame was 22 hours. There was no previous temperature excursion. The call was due to data logger. There was no product quality issue (PQC).
Sex: M
Vaccine: VARZOS
Symptoms: Neoplasm malignant
Clinical narrative: cancer; This case was reported by a pharmacist via call center representative and described the occurrence of cancer in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   In June 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced cancer (serious criteria GSK medically significant). On an unknown date, the outcome of the cancer was unknown.   It was unknown if the reporter considered the cancer to be related to Shingrix.  Additional information was reported as follows: The age at vaccination was not reported. The patient was diagnosed with cancer so the patient did not get 2nd dose of Shingrix. The reporter asked, should the patient start over or just get the second shot even though it had been over one year.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Angina pectoris, Injection site pain, Musculoskeletal pain, Neck pain, Pain in extremity
Clinical narrative: general pains around her heart; injection site pain in the left arm /injection site on her left arm is still painful; general pains down the left side of her neck; general pains on her left shoulder; General pain down her left arm /Arm pain; This case was reported by a consumer via call center representative and described the occurrence of cardiac pain in a 82-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included rheumatoid arthritis (diagnosed at the of age 50). Concomitant products included tramadol.   On 12th September 2019, the patient received the 1st dose of Shingrix. In September 2019, less than a week after receiving Shingrix, the patient experienced cardiac pain (serious criteria GSK medically significant), injection site pain, neck pain, shoulder pain and pain in arm. The patient was treated with ambiguous medication nos (Neurontin (Nos)). On an unknown date, the outcome of the cardiac pain, injection site pain, neck pain, shoulder pain and pain in arm were not recovered/not resolved.   It was unknown if the reporter considered the cardiac pain, injection site pain, neck pain, shoulder pain and pain in arm to be related to Shingrix.  Additional case details were reported as follows: The patient received Shingrix in left arm. The patient reported that the Shingrix shot was the most painful vaccine she had received. The patient reported that within 3 to 4 days of receiving the first dose of the Shingrix vaccine, she began to experienced general pains around her heart, down the left side of her neck, on her left shoulder, and down her left arm. The patient went to her neurologist and was prescribed Neurontin.  The patient said that symptoms now come and go but he injection site on her left arm was still painful. During the call patient said she had pain around her heart. The patient felt that these symptoms were due to how the product was administered to her, not due to the product itself. The patient did not elaborate further. The reporter consented to follow up.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Injection site erythema, Injection site pain, Insomnia, Myalgia
Clinical narrative: Redness and pain around injection site, still there 36 hours later now. The night of the shot, all my joints and muscles in horrendous pain, skin super sensitive, could not sleep at all. In the morning, took 3 Advil and slept about 3 hours sitting up on sofa which helped a lot but didn't feel mostly better until late on Sunday. Today is Monday, and I am achy but functioning again. I have to travel by plane tomorrow and I feel I can do that where on Sunday morning I would not have been able to.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Sensitive skin
Clinical narrative: Redness and pain around injection site, still there 36 hours later now. The night of the shot, all my joints and muscles in horrendous pain, skin super sensitive, could not sleep at all. In the morning, took 3 Advil and slept about 3 hours sitting up on sofa which helped a lot but didn't feel mostly better until late on Sunday. Today is Monday, and I am achy but functioning again. I have to travel by plane tomorrow and I feel I can do that where on Sunday morning I would not have been able to.
Age: 1.25
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: The day after the immunization the mother noted a red, warm, swollen patch at the site of the immunization.  This worsened the following day, so the mother brought the child in for examination.  There was an indurated, erythematous patch about 10 cm in diameter present at the site of the injection
Age: 0.33
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Abnormal behaviour, Blood test normal, Body temperature decreased, Chest X-ray normal, Echocardiogram normal
Clinical narrative: On November 9, 2019 at ~ 10:30 AM I was washing patient in the bathroom sink and I noticed his body became limp with decrease in muscle tone.  His eyes were half open and half closed and was extremely pale.  He did not respond to me and I began breastfeeding him.  At that time he started feeding and was able to track me, however, his color was still very pale.  We called on call pediatrician and recommended we take temperature and it was ranging from 96.5 - 97.5 rectally.  She recommended we go to ER.  We monitored him at home for a little bit and then due to him not being his normal chippy self we decided to take to ER.  Patient was very quiet and chill and not as excited as he usually is.  When driving to ER @ ~ 3:00 PM - 4:00 PM he went unresponsive again in the car seat and his head dropped down.  I (mother) took him out of his car seat and noted him arms and legs were limp and began breastfeeding.  He started feeding and was tracking me, but color was very pale again.  We called 911 and he was transported to Medical Center via ambulance.  During ambulance transport patient was stable and did not have any episodes.  He then spent 4 days in the hospital for testing and monitoring.   Patient was discharged on 11.12.2019.  We have follow up appointments with neurology and an electrophysiologist in December 2019.
Age: 0.33
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Electrocardiogram abnormal, Electroencephalogram abnormal, Hypotonia, Magnetic resonance imaging brain normal, Magnetic resonance imaging normal
Clinical narrative: On November 9, 2019 at ~ 10:30 AM I was washing patient in the bathroom sink and I noticed his body became limp with decrease in muscle tone.  His eyes were half open and half closed and was extremely pale.  He did not respond to me and I began breastfeeding him.  At that time he started feeding and was able to track me, however, his color was still very pale.  We called on call pediatrician and recommended we take temperature and it was ranging from 96.5 - 97.5 rectally.  She recommended we go to ER.  We monitored him at home for a little bit and then due to him not being his normal chippy self we decided to take to ER.  Patient was very quiet and chill and not as excited as he usually is.  When driving to ER @ ~ 3:00 PM - 4:00 PM he went unresponsive again in the car seat and his head dropped down.  I (mother) took him out of his car seat and noted him arms and legs were limp and began breastfeeding.  He started feeding and was tracking me, but color was very pale again.  We called 911 and he was transported to Medical Center via ambulance.  During ambulance transport patient was stable and did not have any episodes.  He then spent 4 days in the hospital for testing and monitoring.   Patient was discharged on 11.12.2019.  We have follow up appointments with neurology and an electrophysiologist in December 2019.