chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.08
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Crying, Diet refusal, Electrocardiogram, Gait disturbance, Irritability
Clinical narrative: Within 2 hours of his 2 month shots our baby was crying uncontrollably, fever and would not eat. When he wasn't crying he was very fussy or lethargic. He remained that way for several days. On the night of March 29th I took him for a walk in the stroller to calm him down. As soon as we entered my house after checking on him a few minutes earlier I realized he wasn't responding to anything (sound, movement, touch, pulling on his arm), he was limp and white/ashen color.
Age: 0.08
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Lethargy, Pallor, Pyrexia, Unresponsive to stimuli
Clinical narrative: Within 2 hours of his 2 month shots our baby was crying uncontrollably, fever and would not eat. When he wasn't crying he was very fussy or lethargic. He remained that way for several days. On the night of March 29th I took him for a walk in the stroller to calm him down. As soon as we entered my house after checking on him a few minutes earlier I realized he wasn't responding to anything (sound, movement, touch, pulling on his arm), he was limp and white/ashen color.
Age: 4.0
Sex: F
Vaccine: HEPA, MMRV
Symptoms: Injection site rash, Pruritus
Clinical narrative: Rash bilateral arms, worse on left. Itching. No fever reported.
Age: 80.0
Sex: M
Vaccine: PNC
Symptoms: Dizziness
Clinical narrative: The patient had become dizzy and had to lay down on the floor.  We helped him up into a bench which he sat there for 15 minutes.
Age: 18.0
Sex: M
Vaccine: ANTH
Symptoms: Aggression, Cerebral haemorrhage, Coagulation factor, Coagulation test, Headache
Clinical narrative: After third shot I still had some minor itching and later a rash. The rash became severe towards the end of my career in 2002. My mood also begin to change as I was becoming much more aggressive. No one could identify what the rash was and it continued to get worse through my marriage after I was out. Eventually I started getting severe headaches and doing very irrational things that I wouldn't normally do. Finally I passed out in the shower and flew me to the hospital to save my life from a brain hemorrhage. This happened twice and I had 5 blood clots throughout. They've tested for every blood clotting Factor known to man they can't come up with anything. My disorder is simply undiagnosed but I have a feeling I know where it came from and I am working hard to play pin-the-tail-on-the-donkey.
Age: 18.0
Sex: M
Vaccine: ANTH
Symptoms: Ill-defined disorder, Loss of consciousness, Mood altered, Pruritus, Rash
Clinical narrative: After third shot I still had some minor itching and later a rash. The rash became severe towards the end of my career in 2002. My mood also begin to change as I was becoming much more aggressive. No one could identify what the rash was and it continued to get worse through my marriage after I was out. Eventually I started getting severe headaches and doing very irrational things that I wouldn't normally do. Finally I passed out in the shower and flew me to the hospital to save my life from a brain hemorrhage. This happened twice and I had 5 blood clots throughout. They've tested for every blood clotting Factor known to man they can't come up with anything. My disorder is simply undiagnosed but I have a feeling I know where it came from and I am working hard to play pin-the-tail-on-the-donkey.
Age: 18.0
Sex: M
Vaccine: ANTH
Symptoms: Thinking abnormal, Thrombosis, Vaccination site pain, Vaccination site pruritus
Clinical narrative: After third shot I still had some minor itching and later a rash. The rash became severe towards the end of my career in 2002. My mood also begin to change as I was becoming much more aggressive. No one could identify what the rash was and it continued to get worse through my marriage after I was out. Eventually I started getting severe headaches and doing very irrational things that I wouldn't normally do. Finally I passed out in the shower and flew me to the hospital to save my life from a brain hemorrhage. This happened twice and I had 5 blood clots throughout. They've tested for every blood clotting Factor known to man they can't come up with anything. My disorder is simply undiagnosed but I have a feeling I know where it came from and I am working hard to play pin-the-tail-on-the-donkey.
Age: 1.25
Sex: F
Vaccine: DTAP, HIBV, PNC13
Symptoms: Breath holding, Crying, Muscle rigidity, Postictal state, Screaming
Clinical narrative: Immunizations givens- baby crying/screaming- appeared to be holding breath- then baby became rigid/stiff-Dr. obtained and babe shaking and then postictal response. Seizure type activity lasted approx 1.5-2 minutes and postictal response approx 5 minutes. Face mask oxygen applied- babe O2 Sats 100% and HR 102-106. Ambulance called- O2 removed when ambulance arrived @ 10:00 a.m. Pt transported to Hospital.
Age: 1.25
Sex: F
Vaccine: DTAP, HIBV, PNC13
Symptoms: Seizure like phenomena
Clinical narrative: Immunizations givens- baby crying/screaming- appeared to be holding breath- then baby became rigid/stiff-Dr. obtained and babe shaking and then postictal response. Seizure type activity lasted approx 1.5-2 minutes and postictal response approx 5 minutes. Face mask oxygen applied- babe O2 Sats 100% and HR 102-106. Ambulance called- O2 removed when ambulance arrived @ 10:00 a.m. Pt transported to Hospital.
Sex: F
Vaccine: PPV
Symptoms: Ear pain, Erythema, Headache, Pain, Pain in extremity
Clinical narrative: This spontaneous report has been received from a nurse via a company representative and refers to a 52-year-old female patient with no pertinent medical history. No information regarding the patient's drug reactions or allergies was provided. On 05-MAY-2017, the patient was vaccinated with a dose of PNEUMOVAX 23 injection (dose, route of administration, lot number and expiration date were not provided) for the prevention of pneumonia. There were no concomitant therapies reported. On 06-MAY-2017, reported as "the next day", the patient woke up with a sore arm. The reporter stated that, on an unspecified date in May 2017, the sore arm had progressed to 103 degree fever, headache, earache and bodyaches. The patient's upper arm had been red, hot and painful (unspecified date in May 2017, reported as "by the time she got in to the doctors office"). The patient sought medical attention by visiting a doctor's office. Treatment given for the adverse events included therapy with ketorolac tromethamine (TORADOL) and an unspecified prescription medication. The outcome of the adverse events experienced by the patient was not reported. No product quality complaint was involved. The relatedness between the adverse events experienced by the patient and PNEUMOVAX 23 was not reported. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Pyrexia, Skin warm
Clinical narrative: This spontaneous report has been received from a nurse via a company representative and refers to a 52-year-old female patient with no pertinent medical history. No information regarding the patient's drug reactions or allergies was provided. On 05-MAY-2017, the patient was vaccinated with a dose of PNEUMOVAX 23 injection (dose, route of administration, lot number and expiration date were not provided) for the prevention of pneumonia. There were no concomitant therapies reported. On 06-MAY-2017, reported as "the next day", the patient woke up with a sore arm. The reporter stated that, on an unspecified date in May 2017, the sore arm had progressed to 103 degree fever, headache, earache and bodyaches. The patient's upper arm had been red, hot and painful (unspecified date in May 2017, reported as "by the time she got in to the doctors office"). The patient sought medical attention by visiting a doctor's office. Treatment given for the adverse events included therapy with ketorolac tromethamine (TORADOL) and an unspecified prescription medication. The outcome of the adverse events experienced by the patient was not reported. No product quality complaint was involved. The relatedness between the adverse events experienced by the patient and PNEUMOVAX 23 was not reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, and concomitant medications were not reported. On 22-MAR-2017, the patient was vaccinated with improperly stored vaccine VARIVAX (lot number: M030138, with an expiration date: 15-JUN-2018; dose regimen details were not provided) as prophylaxis. The nurse could not provide the lot and expiration for the properly stored sterile water diluent used to reconstitute the dose of VARIVAX. No adverse effects were reported. Temperature/Time : 15°F to 46°F (28.4F) for 75 hours Previous temperature excursion? NO Was call because of a "data logger"? NO Additional information has been requested.
Sex: U
Vaccine: HEP, HEPA, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This initial spontaneous report was received from a Certified Medical Assistant (CMA) referring to multiple patients (ages and genders not provided). Medical history and concomitant medications were not provided. On unknown dates, the patients were vaccinated with improperly stored VAQTA, ROTATEQ and RECOMBIVAX HB (lot numbers not provided). Temperature: 47 to 77 degrees Fahrenheit. Time frame: 3 hours. Previous temperature excursion: No. The CMA called because of a data logger. No adverse effects were reported. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Fall, Syncope
Clinical narrative: Information had been received on 17-MAY-2017 from a field representative who was informed by a nurse, at a physician's office, that an 11 year old female patient was administered her second dose of GARDASIL 9 (lot# M035486, expiration 05-JUN-2019) intramuscular injection for prevention of HPV on 10-MAY-2017. On 10-MAY-2017, the patient experienced syncope. The nurse caught the patient as she fell forward. The patient recovered shortly thereafter. No further information available. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist via company representative and refers to  a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 16-MAY-2017, the patient was vaccinated with a dose ZOSTAVAX lot # M037016 with an expiration date 22-NOV-2017, subcutaneously the right arm for prophylaxis. Administered dose of ZOSTAVAX was reconstituted in a sterile diluent (STERILE DILUENT) for 45 minutes, withdrawn into a plastic syringe and stored for one hour outside prescribing storage, reported also as "in either the refrigerator or at room temperature'. No side effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, 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, concomitant medications, drug reactions or allergies was provided. On an unknown date, the patient was vaccinated with a dose of improperly stored ZOSTAVAX, 19400 plaque forming units injection, lot # M038350 with expiration date on 06-DEC-2017 (also reported as unknown) (dose, route and site of administration were not reported), reconstituted with properly stored sterile diluent (MERCK STERILE DILUENT), lot # M044950 with expiration date on 30-MAY-2019. The vaccine experienced temperature excursion of 6-14 degrees Fahrenheit for 1 hour and 15 minutes. Previous excursion of 6-14 degrees Fahrenheit for 1 hour was also reported. Digital data logger was used to record the excursion. No adverse effects were reported. There was no product quality complaint involved in this case. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant 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 between 19-APR-2017 and 23-MAY-2017, the patients were vaccinated with improperly stored doses of VAQTA lot # M033611 with expiration date 02-MAR-2018, lot # M038572 with expiration date 11-MAR-2018, lot # M039202 with expiration date 11-MAR-2018 and lot # N005274 with expiration date 03-APR-2018 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion between 32 and 35 degrees Fahrenheit for 24 hours. A Digital Data logger was not involved. There were no previous temperature excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1705USA014464: US-009507513-1705USA014494: US-009507513-1705USA014496: US-009507513-1705USA014497:
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse, who referred to multiple patients of unknown demographics. No information regarding the patients' pertinent medical history, concomitant therapies and drug reactions or allergies was provided. On unknown dates, the patients were vaccinated with improperly stored doses of M-M-R II recombinant human albumin (rHA) (lot# M029918 with expiration date: 13-JUN-2018, lot# M028130 with expiration date: 03-JUN-2018, lot# M036544 with expiration date: 29-APR-2018; dose, route of administration and anatomical location were not reported) for prophylaxis. The vaccine underwent the temperature excursion of more than 47 Fahrenheit degrees (F) but less than 77 F for 4 hours, which was detected by a data logger. No previous temperature excursions were reported. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of four reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1706USA002227: US-009507513-1706USA002228: US-009507513-1706USA002229:
Age: 1.67
Sex: F
Vaccine: DTAP, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from other health professional and refers to a 1 year old female patient. The patient concomitant therapies included PREVNAR 13, ACTHIB, DAPTACEL, HAVRIX and M-M-R II. On 07-APR-2017 09:30 hrs, the patient was vaccinated with improperly stored VARIVAX (lot # M028553, expiration date: 07-JUN-2018) dose 1, subcutaneously in the left thigh for prophylaxis (incorrect product storage). No adverse effects were reported. The doses of VARIVAX were stored in the temperatures from 15 Fahrenheit degrees (F) to 46 F (23.2 F) for 96 hours (dates were not reported). There were no previous temperature excursions. The digital data logger was not involved. No Product Quality Complaint (PQC) was involved. This case is cross-referenced with 1704USA006422, 1706USA000217, 1706USA000221 and 1706USA001751 (Same reporter link). Additional information has been requested.; Sender's Comments: US-009507513-1704USA006422: US-009507513-1706USA000217: US-009507513-1706USA000221: US-009507513-1706USA001751:
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist, concerning a patient of an unknown age and gender. There were no concurrent conditions, medical history, drug reactions or allergies or concomitant medications reported. On 31-MAY-2017, the patient was vaccinated with an expired dose of VAQTA injection (dose, frequency and route were not reported) lot # M016191 with expiration date of 26-MAY-2017, for prophylaxis. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant, concerning unspecified number of patients of unknown age and gender. There were no concurrent conditions, medical history, drug reactions, allergies or concomitant medications reported. On unspecified dates, the patients were vaccinated with an improperly stored doses (11 doses) of M-M-R II injection (dose, frequency and route were not reported) lot # L037356 with expiration date of 28-SEP-2017 (4 doses) and lot # M028131 with expiration date of 03-SEP-2018 (7 doses), for prophylaxis. The M-M-R II doses were reconstituted with sterile diluent (lot # and expiration date were not reported). The temperature of the M-M-R II was between 47 F and 77 °F for a time frame of 2 hours and 24 minutes. No previous temperature excursion occurred, and data logger was involved. No adverse effects were reported. 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 maedical assistand 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 vaccinated with improperly stored doses of VARIVAX lot # M024680 expiration date  18-MAY-2018 (dose and route of administration were not reported). The vaccines were reconstituted with proplerly stored sterile diluent (lot# and expiration date were nor reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion between 15 degrees Fahrenheit and 46 degrees Fahrenheit for 32 hours. Data logger was not involved. There were no previous excursions 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 nurse, who referred to multiple patients of unknown demographics. No information regarding the patients' pertinent medical history, concomitant therapies and drug reactions or allergies was provided. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ (lot# N000172 with expiration date: 10-JUN-2018, lot# M040267 with expiration date: 14-MAY-2018, lot# M040270 with expiration date: 29-APR-2018, lot# M038744 with expiration date: 26-APR-2018; route of administration defaulted to oral; dose and frequency were not reported) for prophylaxis. The vaccine underwent the temperature excursion of more than 47 Fahrenheit degrees (F) but less than 77 F for 4 hours, which was detected by a data logger. No previous temperature excursions were reported. No adverse effects were reported.  No product quality complaint (PQC) was involved. This is one of four reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1705USA015585: US-009507513-1706USA002227: US-009507513-1706USA002229:
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse, who referred to multiple patients of unknown demographics. No information regarding the patients' pertinent medical history, concomitant therapies and drug reactions or allergies was provided. On unknown dates, the patients were vaccinated with improperly stored doses of VAQTA (lot# M038572 and expiration date: 11-MAR-2018, lot# M047658 and expiration date: 28-OCT-2017; dose, route of administration and anatomical location were not reported) for prophylaxis. The vaccine underwent the temperature excursion of more than 47 Fahrenheit degrees (F) but less than 77 F for 4 hours, which was detected by a data logger. No previous temperature excursions were reported. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of four reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1705USA015585: US-009507513-1706USA002227: US-009507513-1706USA002228:
Sex: F
Vaccine: PNC13
Symptoms: Pneumonia
Clinical narrative: This is a spontaneous report from a contactable pharmacist via a Pfizer sales representative. This pharmacist reported similar events for 2 patients (wife and husband). This is the 1st of 2 reports. A 79-year-old female patient of unspecified race/ethnicity received PREVNAR 13, via an unspecified route of administration, in 2016, at single dose, for immunisation. Relevant medical history and concomitant medications were not reported. On an unspecified date the patient experienced pneumonia, which caused hospitalization. The outcome was unknown. Sender's Comments: Based on the information currently available, a lack of efficacy with pneumococcal 13-valent conjugate vaccine in this patient cannot be completely excluded. Further information like confirmative pathological/serotype results and vaccination schedule are needed for full medical assessment. Linked Report(s): US-PFIZER INC-2017242107 Same reporter/drug/event, different patient.
Sex: M
Vaccine: PNC13
Symptoms: Pneumonia
Clinical narrative: This is a spontaneous report from a contactable pharmacist via a Pfizer sales representative. This pharmacist reported a similar event for 2 patients (wife and husband). This is the 2nd of 2 reports, referred to the husband. This 81 year-old male patient of unspecified race/ethnicity received PREVNAR 13, via an unspecified route of administration, in 2016 at an unspecified age, at single dose, for immunization. Relevant medical history and concomitant medications were not reported. On an unspecified date the patient got pneumonia which caused hospitalization. The outcome of the event was unknown. Sender's Comments: Based on the information currently available, a lack of efficacy with pneumococcal 13-valent conjugate vaccine in this patient cannot be completely excluded. Further information like confirmative pathological/serotype results and vaccination schedule are needed for full medical assessment. Linked Report(s): US-PFIZER INC-2017242084 Same reporter/product/event, different patient.
Sex: U
Vaccine: HPV4, MENB
Symptoms: Guillain-Barre syndrome
Clinical narrative: This is a spontaneous report from a contactable physician via a Pfizer sales representative. A patient of unspecified age, race, ethnicity and gender received a single dose of TRUMENBA and a dose of GARDASIL  (Merck & Co., Inc.), both via an unspecified route of administration on an unspecified date for immunization.  The patient medical history and concomitant medications were not reported.  At the same time of the vaccinations, on an unspecified date, the patient experienced Guillain Barre. The outcome of the event was unknown.; Sender's Comments: The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, as appropriate. The case will be reassessed if additional information becomes available.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to multiple patients of unknown age an gender. No information regarding the patients' concurrent conditions, medical history and concomitant therapies was reported. On unknown dates, the patients received incorrectly stored doses of VAQTA (dose and route of administration were not reported) lot # N003194, expiration date: 28-OCT-2017. No adverse effects were reported. The vaccines were stored in 48 degrees Fahrenheit for 36 minutes. The temperature excursion was detected by a 'Digital Data Logger'. There were no previous temperature excursions. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1705USA009663: US-009507513-1705USA009664:
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse, referring to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not provided. On an unknown dates between 01-JAN-2017 and 16-MAY-2017, the patients were vaccinated with an incorrect storage doses of PNEUMOVAX 23 injection, lot# M032086 expiration date 09-OCT-2017 (strength, dose schedule and route were not provided) for prophylaxis. It was reported that on an unspecified date, the doses of PNEUMOVAX 23 were exposed to a temperature excursion between 32 and 35 Farenheit degrees for 1 hour. The call was placed because of a Data Logger. No adverse reaction was reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to multiple patients of unknown age an gender. No information regarding the patients' concurrent conditions, medical history and concomitant therapies was reported. On unknown dates, the patients received incorrectly stored doses of RECOMBIVAX HB (dose and route of administration were not reported) lot # M044032, expiration date: 03-JUL-2019. No adverse effects were reported. The vaccines were stored in 48 degrees Fahrenheit for 36 minutes. The temperature excursion was detected by a 'Digital Data Logger'. There were no previous temperature excursions. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1705USA009664: US-009507513-1705USA004464:
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 multiple patients of unknown age an gender. No information regarding the patients' concurrent conditions, medical history and concomitant therapies was reported. On unknown dates, the patients received incorrectly stored doses of ROTATEQ orally (dose not reported) lot # M042172, expiration date: 08-JUN-2018. No adverse effects were reported. The vaccines were stored in 48 degrees Fahrenheit for 36 minutes. The temperature excursion was detected by a 'Digital Data Logger'. There were no previous temperature excursions. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1705USA004464: US-009507513-1705USA009663:
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a medical assistant, concerning a patient of an unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 01-MAY-2017, the patient was vaccinated with an improperly stored dose of ROTATEQ with lot # M025568 and expiration date on 07-NOV-2017 (strength and dose were not reported) for prophylaxis. The storage temperature was reported as 47 to 77 degrees Fahrenheit (°F) for a time frame of 7 hours and 15 minutes; but there was a previous temperature excursion reported, with a temperature of 32°F to 35°F for 10 hours. This is one of several reports received from the same source. No product quality complaint (PQC) was involved. Additional information has been requested.; Sender's Comments: US-009507513-1706USA002269: US-009507513-1706USA002268: US-009507513-1706USA002266: US-009507513-1706USA002267:
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions or concomitant medications was provided. On 18-MAY-2017, the patient was vaccinated with an improperly stored dose of VARIVAX that underwent a temperature excursion form 6 Fahrenheit degrees to 14 Fahrenheit degrees during 4 hours (lot # M012990 with an expiration date in 14-MAR-2018), for prophylaxis (dose, frequency, route and dose number were not provided) and was diluted with sterile diluent. No adverse effects were reported and no product quality complaint (PQC) was involved. There was no previous temperature excursion and the digital data logger was involved. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered pharmacist concerning a six patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of ZOSTAVAX, subcutaneously (lot # M035147 with expiration date of 25-OCT-2017; strength, dose and anatomical location were not provided), for prophylaxis, which were administered with sterile diluent (manufacturer unknown). It was also reported that the administered doses experienced a temperature excursion during 3 hours at a temperature between 15 degrees Fahrenheit and 46 degrees Fahrenheit on an unspecified date. No previous temperature excursion was reported. A data logger issue was involved. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Adverse event
Clinical narrative: This spontaneous report was received from a physician via a company representative concerning an unspecified patient of an unknown age and gender. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with GARDASIL intramuscularly (dose, frequency, lot number and expiration date were not reported) for prevention of human papillomavirus (prophylaxis). The physician reported that he was hearing that somebody in a town close, on an unknown date, experienced an unspecified disabling effect (adverse event). At the time of reporting, the outcome of the event was not reported. The causal relationship between the event and GARDASIL was not reported. The reporter considered the adverse event as a disabling event. Additional information is not expected as there are no contact details available.
Sex: F
Vaccine: HPVX
Symptoms: Immediate post-injection reaction, Syncope
Clinical narrative: This spontaneous report was received from a nurse prescriber via a Company representative, referring to a female patient of unknown age. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On an unknown date, the patient was vaccinated with her first dose of GARDASIL or GARDASIL 9 (it could not be confirmed which vaccine was administered) (lot#, frequency and route of administration were unspecified) for prevention of HPV (Human papilloma virus) (prophylaxis), and fainted as soon as the injection was administered. The patient was in the office at the time the adverse event occurred, and was fine within 20 seconds (recovered).  No treatment was administered for the patient's experience. It was reported that no intervention to prevent serious criteria was necessary, that syncope was not significant disability or incapacity or life threatening, and the patient was not hospitalized. No product quality complaint was involved. The relatedness assessment between syncope and GARDASIL or GARDASIL 9 was not provided. Additional information has been requested.
Sex: F
Vaccine: RV5
Symptoms: Infantile spitting up, Oral administration complication
Clinical narrative: This spontaneous report was received from a register nurse, concerning a 2 months-old female patient. The patient's concurrent conditions, concomitant medications, drug reactions or allergies were not reported. The patient had history of spitting up. On an unspecified date, the patient was vaccinated with ROTATEQ (lot #, expiration date, strength and dose were not reported), administered orally for prophylaxis. It was reported that the patient spit up 30 to 40 minutes after receiving the ROTATEQ (Infantile spitting up). No treatment was given for the event. The outcome of the infantile spitting up was not provided. The relatedness between the infantile spitting up and the ROTATEQ was not reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to multiple unknown patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of ZOSTAVAX VIAL 19400 PFU (dosing details and route of administration unknown), lot # M037655 with expiry date 29-NOV-2017 for prophylaxis, which reconstituted with sterile water diluent that was not involved in the temperature excursion. The administered doses experienced a temperature excursion of 6 degree Fahrenheit(F) to 14 degree Fahrenheit(F) for a time frame of 20 minutes. There was no previous temperature excursion. The call was because of a data logger. No adverse effects were reported. There was no product quality complaint (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1706USA001756: US-009507513-1706USA001757: US-009507513-1706USA001758: US-009507513-1706USA001759: US-009507513-1706USA001760: US-009507513-1706USA001761: US-009507513-1706USA001762: US-009507513-1706USA001763:
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Underdose
Clinical narrative: This spontaneous report as received from an office manager concerning a patient of unknown age and gender. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On an unknown date in April 2017, the adult patient was vaccinated with a pediatric dose of RECOMBIVAX HB (drug administered to patient of inappropriate age) (dosing details, lot#, expiry date and route were not provided) for prophylaxis. Therapy with RECOMBIVAX HB was not discontinued. No adverse effect reported. There were no product quality complaints (PQC) involved. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. Approximately in May 2017 (reported as sometime between the dates of 27-MAY-2017 AND 30-MAY-2017), the patient was vaccinated with ZOSTAVAX vial 19400 PFU (plaque-forming units) (lot#, expiry date and dosing details were unknown; reported as injection) for prophylaxis. Other suspect therapy included sterile diluent (MERCK) (dosing details, indication, lot and expiration date were unknown) used to reconstitute ZOSTAVAX. The reconstituted vaccine was given subcutaneously in the patient's forearm. Approximately in May 2017 post vaccination; the patient experienced redness and itchiness at the injection site. The outcome of the events was unknown. The reporter did not provide the causality between the events and the suspect therapies. There were no product quality complaints (PQC) involved. Additional information has been requested.
Sex: U
Vaccine: DTAPIPVHIB, HEPA, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from other health professional and refers to a patient of unknown demographics. The patient's concomitant therapies included diphtheria toxoid, hepatitis B virus vaccine rhbsag (yeast), pertussis acellular 3-component vaccine, poliovirus vaccine inactivated (vero), tetanus toxoid and VAQTA. On 04-APR-2017 10:30 hrs, the patient was vaccinated with improperly stored VARIVAX (lot # M028553, expiration date: 07-JUN-2018) dose 1, subcutaneously in the left thigh for prophylaxis. No adverse effects were reported. The doses of VARIVAX were stored in the temperatures from 15 Fahrenheit degrees (F) to 46 F (23.2 F) for 96 hours (dates were not reported). There were no previous temperature excursions. The digital data logger was not involved. No Product Quality Complaint (PQC) was involved. This case is cross-referenced with 1704USA006422, 1706USA000217, 1706USA000221 and 1706USA000261 (Same reporter link). Additional information has been requested. Sender's Comments: US-009507513-1706USA000221: US-009507513-1706USA000217: US-009507513-1706USA000261: US-009507513-1704USA006422.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to multiple unknown patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX, (dosing details and route of administration unknown) lot # M024683 with expiry date 18-MAY-2018; lot # M023380 with expiry date 11-MAY-2018; lot # L021215 with expiry date 10-JUN-2017 for prophylaxis, which reconstituted with sterile water diluent that was not involved in the temperature excursion. Medical assistant did not know which of the vaccine lot numbers were administered. The administered doses experienced a temperature excursion of 6 degree Fahrenheit (F) to 14 degree Fahrenheit (F) for a time frame of 20 minutes. There was no previous temperature excursion. The call was because of a data logger. No adverse effects were reported. There was no Product Quality Complaint (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1706USA001442: Original Case: 1706USA001442.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to multiple unknown patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 (PFS), (dosing details and route of administration unknown) (lot # M013156 with expiry date 15-OCT-2017; lot # N003997 with expiry date 20-OCT-2018) for prophylaxis. Medical assistant did not know which of the vaccine lot numbers were administered. The administered doses of PNEUMOVAX 23 experienced a temperature excursion of 47 degree Fahrenheit (F) to 77 degree Fahrenheit (F) for a time frame of 50 minutes. There was no previous temperature excursion. The call was because of a data logger. No adverse effects were reported. There was no Product Quality Complaint (PQC) involved. No additional information was provided. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1706USA001442: Original Case: 1706USA001442.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to multiple unknown patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9, (dosing details and route of administration unknown) (lot # L037554 with expiry date 25-DEC-2017; lot # M037770 with expiry date 01-JUN-2019; lot # M035486 with expiry date 05-JUN-2019; lot # M040412 with expiry date 30-JUN-2019) for prophylaxis. Medical assistant did not know which of the vaccine lot numbers were administered. The administered doses of GARDASIL 9 experienced a temperature excursion of 47 degree Fahrenheit (F) to 77 degree Fahrenheit(F) for a time frame of 50 minutes. There was no previous temperature excursion. The call was because of a data logger. No adverse effects were reported. There was no Product Quality Complaint (PQC) involved. No additional information was provided. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1706USA001442: Original Case: 1706USA001442.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to multiple unknown patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of M-M-R II, (dosing details and route of administration unknown) (lot # L024265 with expiry date 01-JUL-2017; lot # M004063 with expiry date 25-JAN-2018; lot # L041457 with expiry date 22-OCT-2017; Lot# M040624 with expiry date 03-OCT-2018) for prophylaxis, which reconstituted with sterile water diluent that was not involved in the temperature excursion. Medical assistant did not know which of the vaccine lot numbers were administered. The administered doses of M-M-R II experienced a temperature excursion of 47 degree Fahrenheit (F) to 77 degree Fahrenheit (F) for a time frame of 50 minutes. There was no previous temperature excursion. The call was because of a data logger. No adverse effects were reported. There was no Product Quality Complaint (PQC) involved. No additional information was provided. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1706USA001442: Original Case: 1706USA001442.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to multiple unknown patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB, (dosing details and route of administration unknown) (lot # M010671 with expiry date 02-JUN-2018; lot # M035487 with expiry date 23-FEB-2019; lot # M041384 with expiry date 07-JUL-2019) for prophylaxis. Medical assistant did not know which of the vaccine lot numbers were administered. The administered doses of RECOMBIVAX HB experienced a temperature excursion of 47 degree Fahrenheit (F) to 77 degree Fahrenheit (F) for a time frame of 50 minutes. There was no previous temperature excursion. The call was because of a data logger. No adverse effects were reported. There was no Product Quality Complaint (PQC) involved. No additional information was provided. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1706USA001442: Original Case: 1706USA001442.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to multiple unknown patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of VAQTA, (dosing details and route of administration unknown) (lot # M036459 with expiry date 18-JAN-2018 (also reported as 08-JAN-2018); lot # M039202 with expiry date 11-MAR-2018; lot # M018767 with expiry date 01-FEB-2018) for prophylaxis. Medical assistant did not know which of the vaccine lot numbers were administered. The administered doses of VAQTA experienced a temperature excursion of 47 degree Fahrenheit (F) to 77 degree Fahrenheit (F) for a time frame of 50 minutes. There was no previous temperature excursion. The call was because of a data logger. No adverse effects were reported. There was no Product Quality Complaint (PQC) involved. No additional information was provided. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1706USA001442: Original Case: 1706USA001442.
Age: 3.0
Sex: F
Vaccine: VARZOS
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Information has been received via medical records from a licensed practical nurse and refers to a 3 year old female patient. On 06-OCT-2009, the patient was vaccinated with ZOSTAVAX, subcutaneously (dose, lot# and expiration date were not reported). This is one of two reports concerning the same patient. Additional information is not expected. All available medical records will be provided upon request. Sender's Comments: US-009507513-1705USA009102.
Age: 0.33
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Crying, Injection site mass, Irritability
Clinical narrative: SMALL LUMP IN LEFT THIGH AT INJECTION SITE, FUSSINESS AND CRYING THROUGH NIGHT.
Age: 18.0
Sex: F
Vaccine: MNQ, TDAP, MNQ, TDAP
Symptoms: Hyperhidrosis, Pallor, Syncope
Clinical narrative: On 06/05/2017 at 3:14 PM received MENVEO and TDAP IM. 3:20 PM escorted to front for check out. 3:24 PM client and mother went to leave and she became syncopal - did not lose consciousness. Pale/diaphoretic 3:25 placed into waiting room chair and feet elevated to another chair - provided wet papertowel to forehead, cold water to drink BP 68/45 with HR 67. 3:30 PM Repeat BP 84/56 HR 68 3:35 PM color returned to face/ lips pink BP 85/70 HR 70 3:45 PM repeat BP 101/70 HR 63. Client and mother were explained vaso vagal response and adverse reactions as described in the VIS received prior to the vaccination. Felt well enough to leave - left with mother.
Age: 18.0
Sex: F
Vaccine: MNQ, TDAP, MNQ, TDAP
Symptoms: Hyperhidrosis, Pallor, Presyncope
Clinical narrative: On 06/05/2017 at 3:14 PM received MENVEO and TDAP IM. 3:20 PM escorted to front for check out. 3:24 PM client and mother went to leave and she became syncopal - did not lose consciousness. Pale/diaphoretic 3:25 placed into waiting room chair and feet elevated to another chair - provided wet papertowel to forehead, cold water to drink BP 68/45 with HR 67. 3:30 PM Repeat BP 84/56 HR 68 3:35 PM color returned to face/ lips pink BP 85/70 HR 70 3:45 PM repeat BP 101/70 HR 63. Client and mother were explained vaso vagal response and adverse reactions as described in the VIS received prior to the vaccination. Felt well enough to leave - left with mother.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Pyrexia
Clinical narrative: Fever of 103, 6 hours after 2 month immunizations.