chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: Blood electrolytes, Full blood count, Haematochezia, Intussusception, Irritability
Clinical narrative: This spontaneous report was received from a physician referring to a 4 month old male patient. The patient did not have any known pertinent medical history, allergies or reactions. Information regarding concomitant therapies was not provided. On 01-MAR-2017, the patient was vaccinated with ROTATEQ lot # M029251 with expiration date of 14-MAR-2018 (strength, dose, frequency, were not provided) orally to prevent rotavirus infection. Then on 01-MAY-2017, the patient became irritable and lethargic, and developed vomiting and blood in the stools. On 02-MAY-2017, the patient was admitted to the hospital and diagnosed with intussusception. The following laboratory studies were performed: complete blood count (CBC), electrolyte levels, basic metabolic panel, x-ray, ultrasound, fluoroscopy with no results provided. An unspecified "emergency life-saving surgical procedure" was performed on the patient on 02-MAY-2017. However, no new medications were started for this patient. The patient was discharged from the hospital on an unknown date in 2017. The patient recovered from the events on an unknown date.  No further information provided. The reporter did not assess the causality between the events and ROTATEQ. The reporter considered the events serious to be life threatening and medically significant as there was an "emergency life-saving surgical procedure" to prevent another serious criteria. Additional information has been requested.
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: Lethargy, Metabolic function test, Surgery, Ultrasound scan, Vomiting
Clinical narrative: This spontaneous report was received from a physician referring to a 4 month old male patient. The patient did not have any known pertinent medical history, allergies or reactions. Information regarding concomitant therapies was not provided. On 01-MAR-2017, the patient was vaccinated with ROTATEQ lot # M029251 with expiration date of 14-MAR-2018 (strength, dose, frequency, were not provided) orally to prevent rotavirus infection. Then on 01-MAY-2017, the patient became irritable and lethargic, and developed vomiting and blood in the stools. On 02-MAY-2017, the patient was admitted to the hospital and diagnosed with intussusception. The following laboratory studies were performed: complete blood count (CBC), electrolyte levels, basic metabolic panel, x-ray, ultrasound, fluoroscopy with no results provided. An unspecified "emergency life-saving surgical procedure" was performed on the patient on 02-MAY-2017. However, no new medications were started for this patient. The patient was discharged from the hospital on an unknown date in 2017. The patient recovered from the events on an unknown date.  No further information provided. The reporter did not assess the causality between the events and ROTATEQ. The reporter considered the events serious to be life threatening and medically significant as there was an "emergency life-saving surgical procedure" to prevent another serious criteria. Additional information has been requested.
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: X-ray
Clinical narrative: This spontaneous report was received from a physician referring to a 4 month old male patient. The patient did not have any known pertinent medical history, allergies or reactions. Information regarding concomitant therapies was not provided. On 01-MAR-2017, the patient was vaccinated with ROTATEQ lot # M029251 with expiration date of 14-MAR-2018 (strength, dose, frequency, were not provided) orally to prevent rotavirus infection. Then on 01-MAY-2017, the patient became irritable and lethargic, and developed vomiting and blood in the stools. On 02-MAY-2017, the patient was admitted to the hospital and diagnosed with intussusception. The following laboratory studies were performed: complete blood count (CBC), electrolyte levels, basic metabolic panel, x-ray, ultrasound, fluoroscopy with no results provided. An unspecified "emergency life-saving surgical procedure" was performed on the patient on 02-MAY-2017. However, no new medications were started for this patient. The patient was discharged from the hospital on an unknown date in 2017. The patient recovered from the events on an unknown date.  No further information provided. The reporter did not assess the causality between the events and ROTATEQ. The reporter considered the events serious to be life threatening and medically significant as there was an "emergency life-saving surgical procedure" to prevent another serious criteria. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, concomitant medication and drug reactions / allergies were unknown. On 13-JUN-2017, the patient was vaccinated with an expired dose of VAQTA )Lot # M009786,  expiration date 26-MAY-2017) dose and route were not reported for prophylaxis. No adverse affects were reported. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant medications and drug reactions/ allergies were unknown. On an unspecified date in June 2017, the patient was vaccinated with improperly stored doses of PROQUAD (Lot # M007960, expiration date 15-AUG-2017 or Lot # M049122, expiration date 13-JUN-2018) dose, route were unknown for prophylaxis (the nurse reported that since 02-JUN-2017 this patient and 5 more received the improperly stored doses of vaccine). The lot # and expiration date for the properly stored sterile Water diluent used to reconstitute the doses of PROQUAD was not provided. No adverse effects were reported. The temperature excursion was from 6°F to 14°F for 1 hour, no previous temperature excursion was reported, the call was because a data logger. No product quality complaint was involved. This is one of 6 cases received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1706USA011002: US-009507513-1706USA011003: US-009507513-1706USA011000: US-009507513-1706USA010999: US-009507513-1706USA011001.
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative, IVth nerve paralysis
Clinical narrative: This spontaneous report was received from a physician concerning a 22 year old female patient. The patient's concurrent conditions included multiple sclerosis diagnosed on an unspecified date that at the time of reporting seemed somewhat stable. Her drug reactions/allergies included nickel rash under allergies. On an unspecified date in 1996 at 13 months of age, the patient was vaccinated with the first dose of VARIVAX as prophylaxis, and on an unspecified date in 2008 at 13 years of age she received the second dose of VARIVAX as prophylaxis (Strength, doses, route of administration, lot numbers and expiration dates were not reported). Other suspect therapies included gabapentin (strength, dose, frequency, route and indication were not provided) started on an unspecified date and interferon beta (strength, dose, route and indication were  nor provided) weekly, started possibly in August 2015. On an unspecified date, the patient experienced left trochlear nerve palsy (IVth nerve paralysis) and was hospitalized on an unknown date in 2015. On an unspecified date in May 2017, the patient had an antibody testing completed by "commercial assay" and the results showed varicella titer as negative at 0.8 (units not provided). It was unknown if treatment was given for the events. The patient was followed by an unspecified neurologist who was interested in an additional dose of VARIVAX but it was not administered yet. The physician also stated that presently the patient was considered to be "otherwise fine". The outcome of IVth nerve paralysis and antibody test negative was unknown. The reporter did not provide the causality between the events and VARIVAX. Upon internal review, the event IVth nerve paralysis was determined to be medically significant. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling
Clinical narrative: This spontaneous report was received from a pharmacist concerning a 70 year old female patient. The patient's concurrent conditions included acid reflux disease. The patient had none drug reactions, allergies or concomitant medications. On 14-JUN-2017, the patient was vaccinated with a single dose of PNEUMOVAX 23 injection, intramuscularly in her left arm, lot number N003997, expiration date 28-OCT-2018 (strength and dose were not reported) for prophylaxis. On the same date (reported as "later that day"), the patient experienced severe swelling of the left arm. The patient was sent to a local unspecified hospital and she was admitted on 14-JUN-2017. The patient was currently being treated with unspecified intravenous antibiotic medication. The pharmacist requested a lot check as soon as possible because she was concerned about using PNEUMOVAX 23 stocked in the pharmacy. At the time of the report, the patient had not recovered from the event. The causality assessment between the event and the PNEUMOVAX 23 was not reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist and from a patient's mother, refers to the patient of unknown age and gender. No information on patient's medical history, concurrent conditions and concomitant medications was provided. On 18-MAY-2017, the patient was vaccinated with an expired dose of GARDASIL 9, intramuscular (dose, lot# and expiry date were not provided). The reporter was informed of the expired dose by an unknown nurse approximately 30 minutes after vaccination. The patient did not experience any adverse effects. Product quality issue was not involved. Additional information is not expected as there was no consent for further contact.
Sex: U
Vaccine: HPV9
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: Information has been received from a pharmacist concerning 2 patients of unknown age and gender. The patients' medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On unknown dates, the patients were vaccinated with the first and second dose of Human Papillomavirus (HPV) series with GARDASIL (dose, strength, route of administration, anatomical location, frequency, lot# and expiration date were not reported), for prophylaxis. On 19-JUN-2017, the patients were vaccinated with the third dose of HPV series with GARDASIL 9 lot# N004799 with expiration date 15-NOV-2019 (dose, strength, route of administration, anatomical location and frequency were not reported), for prophylaxis. No adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On 16-DEC-2016, the patient was vaccinated with an expired dose of PNEUMOVAX 23 lot # L022262, expiration date on 05-NOV-2016 (strength, dose number, route and anatomical location were not provided) for prophylaxis. No adverse events were reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Medical Assistant referring to an unspecified patients of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. The reporter stated that on an unspecified date, 4 doses of improperly stored ROTATEQ orally, lot # M039061, expiration date on 28-APR-2018 (Strength and dose  number were not provided) for prophylaxis had been administered to the patients. It was reported that the dose of ROTATEQ was improperly stored at 47°F to 77°F for 50 minutes. This excursion was detected due to a digital data logger. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 22-JUN-2017, the patient was vaccinated with an expired dose of GARDASIL, lot number L038135, expiry date 27-MAY-2017 (dose and route were not reported) for prophylaxis. No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 18-JUN-2017, the patient may received an improperly stored dose of ROTATEQ orally, lot # M007124, expiration date 05-OCT-2017 (dose was not reported) for prophylaxis. The vaccine was stored at a temperature between 32°F and 35°F, during 48 hours. The report was because of a data logger and there were no previous temperature excursions. No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Death
Clinical narrative: This spontaneous report was received from a social media via company representative regarding a 144 female patients of unknown age. There was no information about patient's concomitant medications and pertinent medical history reported. On an unknown dates, the patients were vaccinated with GARDASIL, (dose, route, anatomical location, lot number and expiration date were not reported) for prophylaxis. It was reported that on unspecified date, the patients died from unknown cause and it was also unknown if autopsy was performed. Additionally it stated that the pharmaceutical companies which made the GARDASIL, as well as the Agency which hold patents and earns profits from the GARDASIL said that they were all coincidence also that the mainstream media denied that these events were even happened. The relatedness between the event and therapy with GARDASIL was not reported. Upon internal review, death was determined to be medically significant event. This is one of several reports from the same source. Additional information is not expected as follow up information cannot be obtained. Sender's Comments: US-009507513-1706USA010923: US-009507513-1706USA010924.
Sex: F
Vaccine: HPV4
Symptoms: Disability
Clinical narrative: This spontaneous report was received from a social media via company representative regarding a female patients of unknown age. There was no information about patient's concomitant medications and pertinent medical history reported. On an unknown dates, the patients were vaccinated with GARDASIL, (dose, route, anatomical location, lot number and expiration date were not reported) for prophylaxis. It was reported that on unspecified date, the patients had become disabled (adverse event). Additionally it stated that the pharmaceutical companies which made the GARDASIL, as well as the Department of Health and Human Services which hold patents and earns profits from the GARDASIL said that they were all coincidence also that the mainstream media denied that these events were even happened. The relatedness between the event and therapy with GARDASIL was not reported. Upon internal review, disability was determined to be medically significant event. The patients had become disabled(adverse event ) was considered to be disabling by the reporter. This is one of several reports from the same source. Additional information is not expected as follow up information cannot be obtained.; Sender's Comments: US-009507513-1706USA010924: US-009507513-1706USA010923:
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and an office manager referring to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. From 26-MAY-2017 to 09-JUN-2017,  the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (lot number M020926 with expiration date of 11-AUG-2018, lot number M031574 with expiration date of 11-NOV-2018, lot number M045653 with expiration date of 03-JUL-2019 and lot number M042322 with expiration date of 21-FEB-2019; strength, dose, route and anatomical location were not provided), for prophylaxis. It was also reported that the administered doses experienced a temperature excursion during 1 hour at a temperature of 51.4 degrees Fahrenheit on unspecified dates. No previous temperature excursion and no adverse effects were reported. A data logger issue was involved. Additional information has been requested.; Sender's Comments: US-009507513-1706USA010931: US-009507513-1706USA005075:
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and an office manager referring to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. From 26-MAY-2017 to 09-JUN-2017,  the patients were vaccinated with improperly stored doses of ROTATEQ (lot number M025569 with expiration date of 18-JAN-2018 and lot number M031807 with expiration date of 02-APR-2018; strength, dose, route and anatomical location were not provided), for prophylaxis. It was also reported that the administered doses experienced a temperature excursion during 1 hour at a temperature of 51.4 degrees Fahrenheit on unspecified dates. No previous temperature excursion and no adverse effects were reported. A data logger issue was involved. Additional information has been requested.; Sender's Comments: US-009507513-1706USA005075: US-009507513-1706USA010930:
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant medications and drug reactions/ allergies were unknown. On an unspecified date in June 2017, the patient was vaccinated with improperly stored doses of PROQUAD (Lot # M007960, expiration date 15-AUG-2017 or Lot # M049122, expiration date 13-JUN-2018) dose, route were unknown for prophylaxis (the nurse reported that since 02-JUN-2017 this patient and 5 more received the improperly stored doses of vaccine). The lot # and expiration date for the properly stored sterile Water diluent used to reconstitute the doses of PROQUAD was not provided. No adverse effects were reported. The temperature excursion was from 6°F to 14°F for 1 hour, no previous temperature excursion was reported, the call was because a data logger. No product quality complaint was involved. This is one of 6 cases received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1706USA006743: US-009507513-1706USA011000: US-009507513-1706USA011001: US-009507513-1706USA011002: US-009507513-1706USA011003.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant medications and drug reactions/ allergies were unknown. On an unspecified date in June 2017, the patient was vaccinated with improperly stored doses of PROQUAD (Lot # M007960, expiration date 15-AUG-2017 or Lot # M049122, expiration date 13-JUN-2018) dose, route were unknown for prophylaxis (the nurse reported that since 02-JUN-2017 this patient and 5 more received the improperly stored doses of vaccine). The lot # and expiration date for the properly stored sterile Water diluent used to reconstitute the doses of PROQUAD was not provided. No adverse effects were reported. The temperature excursion was from 6°F to 14°F for 1 hour, no previous temperature excursion was reported, the call was because a data logger. No product quality complaint was involved. This is one of 6 cases received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1706USA006743: US-009507513-1706USA010999: US-009507513-1706USA011001: US-009507513-1706USA011002: US-009507513-1706USA011003.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant medications and drug reactions/ allergies were unknown. On an unspecified date in June 2017, the patient was vaccinated with improperly stored doses of PROQUAD (Lot # M007960, expiration date 15-AUG-2017 or Lot # M049122, expiration date 13-JUN-2018) dose, route were unknown for prophylaxis (the nurse reported that since 02-JUN-2017 this patient and 5 more received the improperly stored doses of vaccine). The lot # and expiration date for the properly stored sterile Water diluent used to reconstitute the doses of PROQUAD was not provided. No adverse effects were reported. The temperature excursion was from 6°F to 14°F for 1 hour, no previous temperature excursion was reported, the call was because a data logger. No product quality complaint was involved. This is one of 6 cases received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1706USA006743: US-009507513-1706USA010999: US-009507513-1706USA011000: US-009507513-1706USA011002: US-009507513-1706USA011003.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant medications and drug reactions/ allergies were unknown. On an unspecified date in June 2017, the patient was vaccinated with improperly stored doses of PROQUAD (Lot # M007960, expiration date 15-AUG-2017 or Lot # M049122, expiration date 13-JUN-2018) dose, route were unknown for prophylaxis (the nurse reported that since 02-JUN-2017 this patient and 5 more received the improperly stored doses of vaccine). The lot # and expiration date for the properly stored sterile Water diluent used to reconstitute the doses of PROQUAD was not provided. No adverse effects were reported. The temperature excursion was from 6°F to 14°F for 1 hour, no previous temperature excursion was reported, the call was because a data logger. No product quality complaint was involved. This is one of 6 cases received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1706USA006743: US-009507513-1706USA010999: US-009507513-1706USA011000: US-009507513-1706USA011001: US-009507513-1706USA011003.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant medications and drug reactions/ allergies were unknown. On an unspecified date in June 2017, the patient was vaccinated with improperly stored doses of PROQUAD (Lot # M007960, expiration date 15-AUG-2017 or Lot # M049122, expiration date 13-JUN-2018) dose, route were unknown for prophylaxis (the nurse reported that since 02-JUN-2017 this patient and 5 more received the improperly stored doses of vaccine). The lot # and expiration date for the properly stored sterile Water diluent used to reconstitute the doses of PROQUAD was not provided. No adverse effects were reported. The temperature excursion was from 6°F to 14°F for 1 hour, no previous temperature excursion was reported, the call was because a data logger. No product quality complaint was involved. This is one of 6 cases received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1706USA006743: US-009507513-1706USA010999: US-009507513-1706USA011000: US-009507513-1706USA011001: US-009507513-1706USA011002.
Age: 32.0
Sex: F
Vaccine: HEP
Symptoms: Asthenia, Decreased appetite, Diarrhoea, Fatigue, Headache
Clinical narrative: 6/23/17, 10:00 AM - nausea. 6/23/17, 3:00 PM - fatigue. 6/23/17, 5:30 PM - sore throat, stuffy nose. 6/24/17, 6:00 AM - severe fatigue, headache, loss of appetite, severe nausea, weakness. 6/24/17 7:00 AM - vomiting then sleeping. 6/24/17 12:30 PM - vomiting then sleeping. 6/24/17 2:30 PM - weakness, nausea, continued loss of appetite. 6/24/17 7:30 PM - sleep. 6/25/17 6:00 AM - headache, nausea, weakness, tiredness. 6/25/17 9:00 AM - ate a slice of bread and took an ibuprofen. 6/25/17 10:00 AM - headache abated and nausea calmed. 6/25/17 11:00 AM - appetite returned. 6/25/17 3:30 PM - diarrhea, mostly weak and tired for rest of day. 6/26/17 6:00 AM - fatigue.
Age: 32.0
Sex: F
Vaccine: HEP
Symptoms: Nasal congestion, Nausea, Oropharyngeal pain, Somnolence, Vomiting
Clinical narrative: 6/23/17, 10:00 AM - nausea. 6/23/17, 3:00 PM - fatigue. 6/23/17, 5:30 PM - sore throat, stuffy nose. 6/24/17, 6:00 AM - severe fatigue, headache, loss of appetite, severe nausea, weakness. 6/24/17 7:00 AM - vomiting then sleeping. 6/24/17 12:30 PM - vomiting then sleeping. 6/24/17 2:30 PM - weakness, nausea, continued loss of appetite. 6/24/17 7:30 PM - sleep. 6/25/17 6:00 AM - headache, nausea, weakness, tiredness. 6/25/17 9:00 AM - ate a slice of bread and took an ibuprofen. 6/25/17 10:00 AM - headache abated and nausea calmed. 6/25/17 11:00 AM - appetite returned. 6/25/17 3:30 PM - diarrhea, mostly weak and tired for rest of day. 6/26/17 6:00 AM - fatigue.
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Arthralgia, Cough, Headache, Influenza like illness, Oropharyngeal pain
Clinical narrative: Sore throat, followed over next day with achey joints, headache, coughing -- basically felt like the flu.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: This spontaneous report was received from a registered pharmacist and refers to a 50-year-old female patient. The patient's concurrent conditions included numerous unspecified allergies. No information was provided on the patient's pertinent medical history and concomitant medications. On 26-MAY-2017, the patient was vaccinated with a dose of ZOSTAVAX, subcutaneous injection (dose, anatomical location, lot number and expiration date were not reported), for prophylaxis against shingles. On 27-MAY-2017,  the patient's arm had a 2 inch area that was red, sore and swollen. The patient did not seek medical attention and no treatment was given for the events. The outcome of the events was reported as not recovered at the time of this report, however the patient told the pharmacist on an unspecified date that her arm was less red. The reporter did not provide the causality assessment between the events and ZOSTAVAX. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX lot # M006729, expiration date 08-FEB-2018 (dose and route of administration were not reported) reconstituted with properly stored sterile diluent Merck (lot # and expiration date were not reported) for prophylaxis. Administered doses of vaccines experienced the temperature excursion of 15 to 46 degrees Fahrenheit  for 7 hours 30 minutes. Data logger was not involved. There were previous excursions reported. Administered doses of vaccines experienced the temperature excursion of 6 to 14 degrees Fahrenheit  for 4 hours 45 minutes. There was no adverse effect reported. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: VARCEL
Symptoms: Dyspnoea, Hypersensitivity, Tremor, Urticaria
Clinical narrative: Information has been received from a nurse practitioner referring to an 18 year old female patient with allergic rhinitis. The patient's medical history included eczema and childhood asthma. Drug reactions or allergies were unknown.  Concomitant medications were not unknown by reporter. On 18-MAY-2017 the patient was vaccinated with a dose of VARIVAX (lot # M045204, expiration date 11-NOV-2018; dose and site of administration unknown) subcutaneously for "vaccination".  Other suspect therapies included sterile diluent (STERILE DILUENT). Soon after the patient had left, on 18-MAY-2017, the patient experienced shaking, had hives (unspecified location) and was having trouble breathing. The patient returned to office approximately 20 minutes after administration of VARIVAX and was having a "severe allergic reaction". The nurse practitioner reported that she gave the patient prednisone (manufacturer unknown), oxygen, and an unspecified nebulizer as treatment for the severe allergic reaction on 18-MAY-2017. Once the patient was stabilized (on 18-MAY-2017), the nurse practitioner called an ambulance and the patient was transported to the emergency room. The nurse practitioner reported that the patient received unspecified treatment while in the emergency room and was not admitted to hospital. The patient was discharged later that day (18-MAY-2017). The outcome of the event was reported as recovered (on an unspecified date in 2017). Causality assessment was not provided. No product quality complaint (PQC) was involved. "Severe allergic reaction" was considered to be life threatening by the reporting nurse practitioner. Additional information has been requested.
Age: 38.0
Sex: M
Vaccine: HPV9
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a 38-year-old medical assistant who refers to himself. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 22-JUN-2017, at the age of 38, the patient was intramuscularly vaccinated with a dose of GARDASIL 9 (dose, lot# and expiration date were not reported). No side effects were reported. No product quality complaint (PQC) was involved. Additional information is not expected, because there was no consent to contact the reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from an office manager and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 23-JUN-2017, the patient was subcutaneously vaccinated with an expired dose of ZOSTAVAX lot # L046295, expiration date 17-FEB-2017 (dose was not reported). No adverse effect was reported. No product quality complaint (PQC) was not involved. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: HPV4, MENB
Symptoms: Erythema, Hypersensitivity, Local reaction, Pruritus, Swelling
Clinical narrative: Received 6/20 - worsening redness, itching. Swelling on 6/21. To office 6/23/17 with somewhat resolving redness still tender and itching. Given BACTRIM coverage.
Age: 11.0
Sex: M
Vaccine: HPV4, MENB
Symptoms: Tenderness
Clinical narrative: Received 6/20 - worsening redness, itching. Swelling on 6/21. To office 6/23/17 with somewhat resolving redness still tender and itching. Given BACTRIM coverage.
Age: 20.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema
Clinical narrative: Large red area measuring 4.5 X 5 in.
Age: 4.0
Sex: M
Vaccine: HEP, VARCEL
Symptoms: Injection site cellulitis, Injection site erythema, Injection site induration, Injection site papule, Injection site vesicles
Clinical narrative: Cellulitis: 2in x 2in warm, red indurated with tiny papule vesicles around presumed injection site. Treated with cephalexin 250mg/5ml: take 5.5 ml TID for 7 days.
Age: 4.0
Sex: M
Vaccine: HEP, VARCEL
Symptoms: Injection site warmth
Clinical narrative: Cellulitis: 2in x 2in warm, red indurated with tiny papule vesicles around presumed injection site. Treated with cephalexin 250mg/5ml: take 5.5 ml TID for 7 days.
Age: 21.0
Sex: F
Vaccine: MNQ, PPV, TDAP
Symptoms: Injection site pain, Injection site reaction, Muscle tightness, Rash erythematous
Clinical narrative: I was notified that patient was experiencing severe muscle pain and tightness in muscle of injections starting early morning of June 25. Then later that night patient started to develop red bumps near injection site. Patient stated they took several doses of pain reliever, alternated hot and cold therapy on muscle and applied massage with only minimal relief. Patient also took an antihistamine for the red bumps.
Sex: F
Vaccine: TDAP
Symptoms: Pertussis, Vaccination failure
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of vaccination failure in a adult female patient who received BOOSTRIX. Concurrent medical conditions included asthma (severe). In April 2016, the patient received BOOSTRIX. In January 2017, less than a year after receiving BOOSTRIX, the patient experienced vaccination failure (serious criteria GSK medically significant) and pertussis (serious criteria hospitalization and GSK medically significant). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the pertussis was recovered/resolved. It was unknown if the reporter considered the vaccination failure was unknown and the outcome of the pertussis was recovered/resolved. It was unknown if the reporter considered the vaccination failure and pertussis to be related to BOOSTRIX. Additional details were provided as follows: At the time of reporting, the patient was over 50 years of age. The age at vaccination was not reported. The sales representative was asked by the pharmacy if a patient who was given a TDaP vaccine in April 2016 could get a 2nd vaccination because the patient was hospitalized in January 2017 due to pertussis. The medical liaison was consulted due to the off label request. There was no clinical proof that the patient had pertussis as this was reported to the pharmacy by the patient's husband. This case was considered as suspected vaccination failure since the details regarding primary vaccination schedule with DTaP and lab test confirmation was not provided.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner and refers to a multiple unspecified patient's unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies and medical history provided. On an unknown dates the patients were vaccinated with an improperly stored doses of RECOMBIVAX HB lot # M003658 with an expiration date 02-JUN-2018, lot# M036153 with an expiration date 31-MAY-2018 and lot# L016959 with an expiration date 12-MAR-2018 for prophylaxis. No adverse effects were reported. Administered doses of RECOMBIVAX HB experienced the temperature excursion between 32 degrees Fahrenheit and 35 degrees Fahrenheit for 4 days. There was no previous temperature excursion. A digital data logger was not involved.   This is one of several reports received from the same reporter.  Additional information has been requested.; Sender's Comments:  US-009507513-1706USA004379: US-009507513-1706USA004378: US-009507513-1706USA004376: US-009507513-1706USA002585:
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner and refers to a multiple unspecified patients of an unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided. On an unknown dates, the patients were vaccinated with an improperly stored doses of LIQUID PEDVAXHIB lot L042257 with an expiration date 17-AUG-2018, lot# M010440 with an expiration date 09-DEC-2018 for prophylaxis (doses, route of administration were not reported). No adverse effects were reported. Administered doses of LIQUID PEDVAXHIB experienced the the temperature excursion from 32 degrees Fahrenheit to 35 degrees Fahrenheit for 4 days. There was no previous temperature excursion. A digital data logger was not involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1706USA004377: US-009507513-1706USA004376: US-009507513-1706USA002585: US-009507513-1706USA004379:
Age: 41.0
Sex: F
Vaccine: MMR
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to an adult patient of unknown demographics. No information regarding the patient's medical history, concomitant medications, concurrent conditions and drug reactions or allergies was provided. On 20-APR-2017, the patient was vaccinated with the first dose of M-M-R II lot # M034856 with expiration date on 27-JUL-2018. On 09-MAY-2017, 19 days after the first dose, the patient received the second dose of M-M-R II with the same lot number and expiration date. Both doses were reconstituted with sterile diluent (MERCK STERILE DILUENT) lot number M034444 with expiration date on 27-MAR-2019. No adverse effects were reported. There was no Product Quality Complaint (PQC) involved. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative
Clinical narrative: This spontaneous report was received from a registered nurse referring to to a 24 year old patient of unknown gender. There was no information regarding the patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions or allergies reported. In the early 1990's, the patient was vaccinated with RECOMBIVAX HB, (also reported as manufacturer unknown by reporter) (dose, route of administration, lot number and expiration date were not provided) for prophylaxis. The nurse reported that miscellaneous was selected as the product; while no MSD product could be specifically identified as the agent in question, MSD products were also not able to be ruled out.  On an unknown date, the nurse reported that the patient had "titers tested on 09-JUN-2017 which demonstrated negative for immunity". Treatment (unspecified) was given for the patient's adverse event. The outcome of hepatitis b surface antibody negative was unknown. Causality assessment was not provided.      Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Dizziness, Injection site reaction, Injection site vesicles, Nausea, Pyrexia
Clinical narrative: Information has been received from a physician via a company representative referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not provided. On an unknown date in approximately 2015, reported as 1-2 years ago, the patient was vaccinated with ZOSTAVAX (dose, lot number and expiration date unknown) for prevention of shingles. On an unknown date, the physician stated that the patient complained of injection site reaction {unspecified date) of blistering, nausea, fever, and dizziness. The physician stated that the patient's symptoms seem to be "vague systemic symptoms" of nausea, fever, and dizziness. The physician stated also that it appeared to be an "immune complex hyper sensitivity type of reaction or serum sickness. No treatment information was given for this incident. The physician did not recall what else took place with the patient. No other information was provided on this matter. The outcome of the events was unknown. The causal relationship between ZOSTAVAX and the events was not provided. Upon internal review, "immune complex reaction" was determined to be medically significant.  Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Serum sickness, Type III immune complex mediated reaction
Clinical narrative: Information has been received from a physician via a company representative referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not provided. On an unknown date in approximately 2015, reported as 1-2 years ago, the patient was vaccinated with ZOSTAVAX (dose, lot number and expiration date unknown) for prevention of shingles. On an unknown date, the physician stated that the patient complained of injection site reaction {unspecified date) of blistering, nausea, fever, and dizziness. The physician stated that the patient's symptoms seem to be "vague systemic symptoms" of nausea, fever, and dizziness. The physician stated also that it appeared to be an "immune complex hyper sensitivity type of reaction or serum sickness. No treatment information was given for this incident. The physician did not recall what else took place with the patient. No other information was provided on this matter. The outcome of the events was unknown. The causal relationship between ZOSTAVAX and the events was not provided. Upon internal review, "immune complex reaction" was determined to be medically significant.  Additional information has been requested.
Sex: M
Vaccine: HPV9
Symptoms: Injection site nodule, Injection site pain, Injection site swelling, Injection site warmth, Sinusitis
Clinical narrative: This spontaneous report was received from a pediatrician and refers to a 15-year-old male patient. The patient did not have any concurrent conditions, medical history, allergies or known drug reactions and did not take any concomitant medications. On 19-MAY-2017, the patient was vaccinated with GARDASIL 9 injection, intramuscularly, lot # N003703, expiration date: 29-OCT-2019. On an unknown date in approximately 2017, the patient had minimal injection site tenderness. On an unknown date in 2017 (reported as "an unspecified time after receiving GARDASIL 9), the patient developed a sinus infection and was prescribed amoxicillin (dates unspecified). On 12-JUN-2017, the patient experienced injection site pain rated as "2" and increased swelling. The physician prescribed heat on the injection site and ADVIL as a treatment, on 12-JUN-2017. The physician saw the patient at the office on 16-JUN-2017 due to the patient experiencing injection site swelling and tenderness about 2 inches diameter and induration about 3/4 inches diameter which felt like a knot (developed on unknown date). On 16-JUN-2017, the patient was afebrile. The outcome of the events was unknown. The causality assessment between the events and GARDASIL 9 was not provided. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to unspecified number of patients of unknown age and gender. No information on patients medical history, concurrent conditions and concomitant medications was provided. On unspecified dates, sometime in June 2017, the patients received improperly stored VARIVAX lot # M048203, expiry date: 07-DEC-2018 (dose, route of administration were not provided). The sterile diluent (STERILE DILUENT) (lot number N003192, expiration date 05-JUL-2019) used to reconstitute the VARIVAX was properly stored. Digital data logger detected that the vaccine was stored in temperature from 15°F to 46°F for 2 hours. There was no previous temperature excursion. No product quality complaint was involved in this case. No symptoms were reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were intramuscularly vaccinated with a "single dose" of improperly stored GARDASIL 9 lot # M031557, expiration date 07-APR-2019 (dose was not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 49 degrees Fahrenheit for 14 hours. The vaccines experienced previous temperature excursion of 47 degrees Fahrenheit for 24 hours and 32 degrees Fahrenheit for 15 hours. Data logger was not involved. No product quality complaint (PQC) was involved. Additional information is not expected, because there was no consent to contact the reporter.
Age: 85.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Peripheral swelling
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program [IBCC (Inbound Call Center for HCPs)]. A contactable nurse reported that a 85 year-old female patient received, on 19Jun2017 around 10 am, the first dose of PREVENAR 13 (lot S06823, expiry date May2018, NDC number: 0005197102) intramuscularly, in the right arm, at 0.5 ml, single, for immunization. Relevant medical history included diabetes (ongoing). Concomitant medications included oral atenolol, Tablet, 50 mg, twice daily, from an unspecified date, in Nov2016 (ongoing), for blood pressure; vitamin b complex (Tablet) 1 DF, daily, from an unspecified date, in Jun2014 (ongoing); FLONASE (Nasal spray, solution) 50 mcg, two spray each nostril daily, from an unspecified date, in Jun2014 (ongoing); hydrochlorothiazide / losartan potassium 12.5 mg/50 mg, one tablet daily, from an unspecified date, in Aug2016 (ongoing); metformin hydrochloride 500 mg, daily from an unspecified date, in Apr2017 (ongoing), for diabetes; oral nifedipine Tablet, 600 mg, daily from an unspecified date, in Feb2016 (ongoing), oral simvastatin Tablet, 20 mg, daily from an unspecified date, in Jun2015 (ongoing); oral vitamin D nos, capsule, 50000 one weekly om an unspecified date, in Apr2017 (ongoing); and nystatin cream 100,000 per 0.1 unit cream, from an unspecified date, in Jun2014 (ongoing). On 19Jun2017, about 5 to 10 minutes after receiving the vaccine, the patient's right arm swelled up. No medical treatment provided for adverse event and no hospitalization was required. The patient did not recover from the adverse event at time of this report.