chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 8.0
Sex: M
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 8 year old male patient. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 29-NOV-2016, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(manufacturer unknown), lot # M015735 with expiration date of 30-MAR-2018 (dose, route and frequency were not reported) for prophylaxis. It was stated that the vaccine underwent a temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 63 days. It was reported that there was no need to repeat vaccine. This is one of the several reports received from the same reporter.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: Information was received from a nurse referring to an unknown number of unspecified patients of unknown age and gender. The patients' medical history and concurrent conditions were not reported. On unspecified dates, the patients were administered doses of improperly stored PROQUAD injection, recombinant human albumin (rHA)/human serum albumin (HSA) (lot# M046943, expiration date 27-MAY-2018; lot# M049122, expiration date 13-JUN-2018) (Strength, dose, frequency, anatomical location and route were not reported) for prophylaxis. The concomitant therapy included sterile diluent which was used to reconstitute PROQUAD injection, was stored properly. The vaccines were exposed to 6 to 14 Fahrenheit degree (F) for 1.5 hours. There was no previous temperature excursion. Digital data logger was involved. No adverse effects was reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1707USA012152: US-009507513-1707USA012415: US-009507513-1707USA012416: US-009507513-1707USA012418: US-009507513-1707USA012419.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Information was received from a nurse referring to an unknown number of unspecified patients of unknown age and gender. The patients' medical history and concurrent conditions were not reported. On unspecified dates, the patients were administered doses of improperly stored VARIVAX injection (lot# M049126, expiration date 15-DEC-2018) (Strength, dose, frequency, anatomical location and route were not reported) for prophylaxis. The concomitant therapy included sterile diluent which was used to reconstitute VARIVAX injection, was stored properly. The vaccines were exposed to 6 to 14 Fahrenheit degree (F) for 1.5 hours. There was no previous temperature excursion. Digital data logger was involved. No adverse effects was reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1707USA012152: US-009507513-1707USA012415: US-009507513-1707USA012416: US-009507513-1707USA012417: US-009507513-1707USA012419.
Sex: U
Vaccine: DTAPIPV, MMRV
Symptoms: Rash
Clinical narrative: Initial unsolicited report received from a non-healthcare professional (Office staff) on 17-Jul-2017. This case involves a two patients (age and gender was not reported) who were vaccinated with dose of QUADRACEL and dose of PROQUAD (batch number, expiry date, route and site of administration were not reported for both vaccines) in same limb an unspecified date. Medical history and concomitant medication were not reported. On an unspecified date following vaccination patients had large bumps (4-5" in diameter) each. It was reported that nurse could not remember patient initials or dates. She was willing to look, but said it would take some time. Reporter encouraged her also to call the home office to report. Reporter forgot to ask for the lot number. Laboratory investigation and corrective treatment were not reported. Outcome of event was not reported. List of documents held by sender: none.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Pyrexia
Clinical narrative: FEVER UP TO 103 DEGREES X 3 DAYS THEN RESOLVED.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Burning sensation, Facial pain, Rash, Rash vesicular
Clinical narrative: Slight burning, blistering rash on outer side of right eye with a slightly less severe outbreak on outside of left eye. Noticed burning, slightly painful sensation while washing face on Friday evening (July 28th). Size of affected area about nickel sized. No severe blistering or discharge. As of morning of July 31st, both areas are mostly healed up. I did not seek medical help or treatment.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Syringe issue
Clinical narrative: This spontaneous report as received from a pharmacist 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 ZOSTAVAX, subcutaneous (lot number and expiration date not reported)for prophylaxis. The pharmacist reported that the patient received only "about half of a dose" of ZOSTAVAX, because the syringe leaked at the place where the needle is connected to the syringe (manufacturer unknown). No adverse event. Additional information has been requested.
Sex: U
Vaccine: UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a medical assistant who reported that on unknown dates, multiple unspecified patients were administered the following improperly stored vaccines: VAQTA (lot #N005605,  expiration date 08-APR-2018); ROTATEQ (lot #M041184, expiration date 31-MAY-2018 and lot #M042171, expiration date 07-JUN-2018); RECOMBIVAX HB, (lot #M041384, expiration date 07-JUL-2019; lot #L045117, expiration date 06-OCT-2018; and lot #M010212, expiration date 21-JAN-2019); GARDASIL 9 (lot #L043213, expiration date 28-AUG-2017; lot #M009378, expiration date 23-APR-2018; lot #M024261, expiration date 30-JUL-2018; lot #M032650, expiration date 31-MAR-2019; lot #M042853, expiration date 17-JUL-2019; and lot #M043731, expiration date 22-JUN-2019); M-M-R II (lot #M016234, expiration date 31-MAR-2018; lot #M034387, expiration date 19-JUL-2018; lot #M036543, expiration date 15-AUG-2018; lot #M039913, expiration date 26-SEP-2018; and lot #M042846, expiration date 21-OCT-2018); PNEUMOVAX23 syringe (lot #M032635, expiration date 05-MAY-2018); PROQUAD (lot # N000336, expiration date 03-JUL-2018); VARIVAX (lot #M033211, expiration date 13-JUL-2018; lot #M045205, expiration date 11-NOV-2018; lot #M049126, expiration date 15-DEC-2018; and lot #N014366, expiration date 09-MAY-2019); ZOSTAVAX (lot #M041511, expiration date 08-JAN-2018); and PEDVAXHIB (lot #M034189, expiration date 23-MAY-2019; and lot #M046140, expiration date 27-SEP-2019) (dosages and routes of administration not provided), which had been reconstituted with properly stored sterile diluent. No adverse effects were reported. Temperature and time frame: 47°F to 77°F, 21 minutes; 6°F to 14°F, 42 minutes. Previous temperature excursion: No. Data logger involved: Yes. No additional information provided. Additional information has been requested.
Sex: U
Vaccine: MMR
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. The patient's medical history and concurrent conditions were not reported. Concomitant therapies included sterile diluent. On 06-JUL-2017, the patient was inadvertently vaccinated with one dose of M-M-R II lot # L024267, expiration date 01-JUL-2017 (dose and route were not reported) for prophylaxis. No adverse effects were reported.
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an 18 year old non-pregnant female patient. On 27-MAR-1999, 27-MAY-1999, and 02-NOV-1999, the patient was vaccinated with hepatitis b vaccine (recombinant)(manufacturer unknown) for prophylaxis. On an unknown date the patient experienced hepatitis b antibody negative. The outcome of hepatitis b antibody negative is unknown. The causality assessment was not provided. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Skin irritation
Clinical narrative: This spontaneous report was received from a male patient of unknown age referring on himself. On an unknown date, the patient was vaccinated with ZOSTAVAX, subcutaneous for prophylaxis. On an unknown date, the patient experienced erythema and skin irritation. The outcome of erythema and skin irritation was unknown. The relatedness between the event and ZOSTAVAX was not reported. Additional information is not expected as there was no consent to contact the reporter.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse regarding a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 25-JUL-2017, the patient was vaccinated with expired dose of PROQUAD, (lot # M001152 with expiration date 05-JUL-2017) (dose and route were not reported), for prophylaxis. Concomitant therapies included sterile diluent. No adverse effect was reported. The action taken and outcome of the events was unknown. Additional information has been requested.
Sex: U
Vaccine: HIBV, HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown date, the patient might have received an improperly stored dose of one of the following vaccine: PEDVAXHIB (lot # N000236; expiry date: 24-OCT-2019) (or) GARDASIL 9 (lot # M040412; expiry date: 30-JUN-2019) for prophylaxis (dosing details not reported). The vaccine was exposed to a temperature of 30.9 degree Fahrenheit (F) for 24 hours. No adverse effect was reported. This report was due to digital data logger. There was no previous temperature excursion. Product quality complaint was not involved.
Age: 39.0
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 39 year old female patient. The patient's concurrent conditions and medical history were not reported. On 19-OCT-2016, the patient was vaccinated with an improperly stored dose of VARIVAX lot # M008173 with expiration date of 16-FEB-2018 (dose, route and frequency were not reported) for prophylaxis. Again on 18-JAN-2017, she was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(manufacturer unknown) lot # M018436 with expiration date of 13-APR-2018 (dose, route and frequency were not reported) reconstituted with properly stored sterile diluent (MRK) for prophylaxis. No adverse effects were reported. Both lots underwent a temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 22 days (for lot # M008173) and 113 days (for lot # M018436). It was reported that there was no need to repeat vaccine. No previous temperature excursion. The call was not because of a "data logger". There was no Product Quality Complaint (PQC) involved in this case. No further information was provided. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1705USA014053.
Age: 24.0
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 24 year old female patient. The patient's concurrent conditions and medical history were not reported. On 17-JAN-2017, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(manufacturer unknown) lot # M018436 with expiration date of 13-APR-2018 (dose, route and frequency were not reported) reconstituted with properly stored sterile diluent (MRK) for prophylaxis. No adverse effects were reported. It was stated that the vaccine underwent a temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 112 days. It was reported that there was no need to repeat vaccine. No previous temperature excursion. The call was not because of a "data logger". There was no Product Quality Complaint (PQC) involved in this case. No further information was provided. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1705USA014053.
Age: 2.0
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 2 year old male patient. The patient's concurrent conditions and medical history were not reported. On 07-DEC-2016, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(manufacturer unknown) lot # M018436 with expiration date of 13-APR-2018 (dose, route and frequency were not reported) reconstituted with properly stored sterile diluent (DILUENT MRK) for prophylaxis. No adverse effects were reported. It was stated that the vaccine underwent a temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 71 days. It was reported that there was no need to repeat vaccine. No previous temperature excursion. The call was not because of a "data logger". There was no Product Quality Complaint (PQC) involved in this case. No further information was provided. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1705USA014053:
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 10 year old female patient. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 29-NOV-2016, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (manufacturer unknown), lot # M015735 with expiration date of 30-MAR-2018 (dose, route and frequency were not reported) for prophylaxis. It was stated that the vaccine underwent a temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 63 days. It was reported that there was no need to repeat vaccine. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1705USA014053.
Age: 2.0
Sex: M
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 2 year old male patient. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 29-NOV-2016, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(manufacturer unknown), lot # M015735 with expiration date of 30-MAR-2018 (dose, route and frequency were not reported) for prophylaxis. It was stated that the vaccine underwent a temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 63 days. It was reported that there was no need to repeat vaccine. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1705USA014053:
Age: 34.0
Sex: F
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 34 year old female patient. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 26-OCT-2016, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (manufacturer unknown), lot # M015735 with expiration date of 30-MAR-2018 (dose, route and frequency were not reported) for prophylaxis. It was stated that the vaccine underwent a temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 29 days. It was reported that there was no need to repeat vaccine. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1705USA014053.
Age: 22.0
Sex: F
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 22 year old female patient. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 23-NOV-2016, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(manufacturer unknown), lot # M015735 with expiration date of 30-MAR-2018 (dose, route and frequency were not reported) for prophylaxis. It was stated that the vaccine underwent a temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 57 days. It was reported that there was no need to repeat vaccine. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1705USA014053:
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 5 year old male patient. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 13-DEC-2016, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(manufacturer unknown), lot # M015735 with expiration date of 30-MAR-2018 (dose, route and frequency were not reported) for prophylaxis. It was stated that the vaccine underwent a temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 77 days. It was reported that there was no need to repeat vaccine. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1705USA014053:
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 5 year old male patient. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 09-DEC-2016, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(manufacturer unknown), lot # M015735 with expiration date of 30-MAR-2018 (dose, route and frequency were not reported) for prophylaxis. It was stated that the vaccine underwent a temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 73 days. It was reported that there was no need to repeat vaccine. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1705USA014053:
Age: 31.0
Sex: F
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 31 year old female patient. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 14-DEC-2016, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(manufacturer unknown), lot # M015735 with expiration date of 30-MAR-2018 (dose, route and frequency were not reported) for prophylaxis. It was stated that the vaccine underwent a temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 78 days. It was reported that there was no need to repeat vaccine. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1705USA014053:
Age: 40.0
Sex: F
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to a 40 year old female patient. On 26-JUL-2017, the patient was vaccinated with a dose of pediatric VAQTA (lot#, dosing details and route unspecified) for prophylaxis, instead of an adult dose (drug administered to patient of inappropriate age). No adverse effects reported. No product quality complaint was involved. No further information provided. There was a consent to follow up.
Sex: U
Vaccine: FLU3
Symptoms: Respiratory disorder
Clinical narrative: Initial unsolicited report received from a physician on 20 July 2017. This case involves a patient (age and gender was not reported) who was vaccinated with a dose of FLUZONE HIGH DOSE (batch number, expiration date, route, dose not reported) on an unspecified date. Patient's ongoing illness, medical history and concomitant medications were not reported. On an unspecified date, following the vaccination, the patient had a severe respiratory reactions. Lab data and corrective treatment was not reported. The outcome of the event was not reported. List of documents held by sender: none.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site reaction, Irritability, Pyrexia, Rash, Rash erythematous
Clinical narrative: 1-2 days after vaccine, child became very fussy. Subjective intermittent fevers. Then on the 28th July, mother noticed an erythematous rash on left thigh, that quickly progressed to vesicular. THe patch of vesicles was about 5cm in diameter. Over the next couple of days she developed vesicular rash on both knees and right arm. She still has the rash. My concern is wth the pregnant mother. I understand vaccinal type is attenuated, but does mother need Varicella immunoglobuly post exposure? Thank you.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash vesicular
Clinical narrative: 1-2 days after vaccine, child became very fussy. Subjective intermittent fevers. Then on the 28th July, mother noticed an erythematous rash on left thigh, that quickly progressed to vesicular. THe patch of vesicles was about 5cm in diameter. Over the next couple of days she developed vesicular rash on both knees and right arm. She still has the rash. My concern is wth the pregnant mother. I understand vaccinal type is attenuated, but does mother need Varicella immunoglobuly post exposure? Thank you.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Pyrexia, Vomiting
Clinical narrative: FEVER 101, VOMITTING BEGAN ON 07-27-2017 CONTINUED THRU 7-29-2017 THEN RESOLVED.
Age: 13.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Vomiting
Clinical narrative: Parent called and spoke to telephone triage nurse. Chief complaint of vomiting - per the parent this "happens each time the patient gets a vaccine". Home care advise was offered over the phone for the vomiting, but parent declined home care advise as patient's symptoms had resolved. Parent was instructed/informed that due to length of time between onset of symptoms and time of vaccinations was unlikely related, parent still wanted to inform PCP since this happens with "every vaccination".
Age: 37.0
Sex: M
Vaccine: TDAP
Symptoms: Erythema, Induration
Clinical narrative: Developed 6x7 cm area of induration and erythema, lasted 4 days.
Age: 0.5
Sex: M
Vaccine: DTAP
Symptoms: Crying, Mental disorder, Pyrexia, Viral infection
Clinical narrative: Within a few hours of the shot patient was inconsolible crying with a fever topping 105'. I called the after hours exchange and was told it was just a virus and it WAS NOT because of the vaccine. I called the Dr the next day and he said that same thing. The fever lasted a few days. Directly after that his mental stability started to break down.
Age: 1.0
Sex: M
Vaccine: DTAP
Symptoms: Abnormal behaviour, Clumsiness, Fall, Gait disturbance, Regressive behaviour
Clinical narrative: He just stopped being normal. no fever, but reverted to a baby, not walking normal, always falling down, very clumbsy. stopped all speech.
Age: 1.0
Sex: M
Vaccine: DTAP
Symptoms: Speech disorder
Clinical narrative: He just stopped being normal. no fever, but reverted to a baby, not walking normal, always falling down, very clumbsy. stopped all speech.
Age: 47.0
Sex: F
Vaccine: HEP
Symptoms: Burning sensation, Erythema, Eye swelling, Pruritus, Swelling
Clinical narrative: Redness, swelling, itching and burning around eyes mouth and neck .It is not hives or a rash, looks and feels like burns. Took Prednisone injections and oral tablets, cortisone cream, as well as several antihistamines. Also saw an allergists, given same treatment. This will not go away, only gets somewhat better as long as I am taking large doeses of medication. Has not completely gone away. I have photos of each episode. I am very concerned there may be scaring.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information was received on 10-JUL-2017 from a nurse who reported that an 18 year old unspecified patient (gender not reported) received the first dose of GARDASIL 9 (unspecified lot/expiration) on an unspecified date in April 2016, the second dose of GARDASIL 9 (lot# N003703, expiration 29-OCT-2019) on 26-JUN-2017 and the third dose of GARDASIL 9 (lot# N003703, expiration 29-OCT-2019) on 07-JUL-2017. No adverse effect reported. No further information was provided. Additional information has been requested.
Sex: F
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information was received 11-JUL-2017 via a phone call from a medical assistant who reported that a female patient of unspecified age was inadvertently administered one expired dose of MMR II on 11-JUL-2017 (Lot number L024268, expiration date 01-JUL-2017). Concomitant Merck sterile diluent was used (Lot number M047667, expiration date 25-JUL-2019). No adverse effects were reported. No further information was reported. Additional information was requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Information was received on 17-JUL-2017 from a nurse who was reporting on multiple unspecified patients. No medical history or concomitant medications were reported. The nurse reported that improperly stored vaccines were administered to multiple unspecified patients on unspecified dates (dose, route and injection site not reported). The nurse was unable to provide the lot numbers and expiration dates for the properly stored sterile diluent that were used to reconstitute the vaccines. No adverse effects were reported. No additional information is available. The vaccines included VARIVAX lot M042497, expires 03-AUG-2018, lot M006157, expires 05-FEB-2018, and PROQUAD lot M042497, expires 17-APR-2018. Out of range temperatures and time frame was not specified. There were multiple unspecified excursions reported on data logger. Follow-up information was received on 18-JUL-2017. The nurse called back to provided information that the vaccines were stored in the temperature range of: -9 degrees C to 8 degrees C for 10 consecutive months. No additional information was provided. Additional information is expected. No further information is available.
Sex: F
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information was received on 17-JUL-2017 from a physician who was reporting on a female patient of unknown age. No medical history or concomitant medications were reported. The physician reported that on 17-JUL-2017, the patient inadvertently received an expired dose of MMR II (lot M032153, expires 22-APR-2017, dose, route and site not reported). No adverse effects reported. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Eczema
Clinical narrative: This spontaneous report as received from a nurse refers to a male patient of unknown age. On an unspecified date in January 2017 the patient was vaccinated with ZOSTAVAX. On an unspecified date in 2017 the patient experienced eczema. The outcome of eczema is unknown.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse referring to a 14 year old female patient. On 26-MAY-2017 the patient was vaccinated with GARDASIL lot # L035105 for prophylaxis. On 26-MAY-2017, the patient experienced expired product administered. On an unknown date the patient experienced no adverse event. The outcome of expired product administered and no adverse event is unknown. The reporter considered expired product administered and no adverse event to be not related to GARDASIL. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1707USA006834.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a Physician refers to an unspecified number of patients of unknown age and gender. On unknown date, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot number reported as: M0007764, expiration date on: 01-JUN-2019 for prophylaxis. The administered doses of the vaccine were exposed to a temperature excursions of 32 °F (degrees Fahrenheit) to 35°F (degrees Fahrenheit) for 123 hours and 31 °F (degrees Fahrenheit) for colder for 35 hours (coldest 26 °F). A digital data logger was involved. No adverse events were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1707USA013063: US-009507513-1707USA013064.
Age: 43.0
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 43 year old male patient. The patient's concurrent conditions and medical history were not reported. On 23-DEC-2016, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(manufacturer unknown) lot # M018436 with expiration date of 13-APR-2018 (dose, route and frequency were not reported) reconstituted with properly stored sterile diluent (MRK) for prophylaxis. No adverse effects were reported. It was stated that the vaccine underwent a temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 87 days. It was reported that there was no need to repeat vaccine. No previous temperature excursion. The call was not because of a "data logger". There was no Product Quality Complaint (PQC) involved in this case. No further information was provided. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1705USA014053.
Age: 40.0
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 40 year old female patient. The patient's concurrent conditions and medical history were not reported. On 23-DEC-2016, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(manufacturer unknown) lot # M018436 with expiration date of 13-APR-2018 (dose, route and frequency were not reported) reconstituted with properly stored sterile diluent (DILUENT MRK) for prophylaxis. No adverse effects were reported. It was stated that the vaccine underwent a temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 87 days. It was reported that there was no need to repeat vaccine. No previous temperature excursion. The call was not because of a "data logger". There was no Product Quality Complaint (PQC) involved in this case. No further information was provided. This is one of the several reports received from the same reporter.
Age: 10.0
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 10 year old male patient. The patient's concurrent conditions and medical history were not reported. On 05-JAN-2017, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(manufacturer unknown) lot # M018436 with expiration date of 13-APR-2018 (dose, route and frequency were not reported) reconstituted with properly stored sterile diluent (MRK) for prophylaxis. No adverse effects were reported. It was stated that the vaccine underwent a temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 93 days. It was reported that there was no need to repeat vaccine. No previous temperature excursion. The call was not because of a "data logger". There was no Product Quality Complaint (PQC) involved in this case. No further information was provided. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1705USA014053.
Age: 26.0
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 26 year old female patient. The patient's concurrent conditions and medical history were not reported. On 25-JAN-2017, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(manufacturer unknown) lot # M018436 with expiration date of 13-APR-2018 (dose, route and frequency were not reported) reconstituted with properly stored sterile diluent (DILUENT MRK) for prophylaxis. No adverse effects were reported. It was stated that the vaccine underwent a temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 113 days. It was reported that there was no need to repeat vaccine. No previous temperature excursion. The call was not because of a "data logger". There was no Product Quality Complaint (PQC) involved in this case. No further information was provided. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1705USA014053:
Age: 24.0
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 24 year old female patient. The patient's concurrent conditions and medical history were not reported. On 27-DEC-2016, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(manufacturer unknown) lot # M018436 with expiration date of 13-APR-2018 (dose, route and frequency were not reported) reconstituted with properly stored sterile diluent (DILUENT MRK) for prophylaxis. No adverse effects were reported. It was stated that the vaccine underwent a temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 91 days. It was reported that there was no need to repeat vaccine. No previous temperature excursion. The call was not because of a "data logger". There was no Product Quality Complaint (PQC) involved in this case. No further information was provided. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1705USA014053.
Age: 35.0
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 35 year old female patient. The patient's concurrent conditions and medical history were not reported. On 16-NOV-2016, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(manufacturer unknown) lot # M015735 with expiration date of 30-MAR-2018 (dose, route and frequency were not reported) for prophylaxis. Again on 21-DEC-2016, she was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(manufacturer unknown) lot # M018436 with expiration date of 13-APR-2018 (dose, route and frequency were not reported) reconstituted with properly stored sterile diluent (DILUENT MRK) for prophylaxis. No adverse effects were reported. Both lots underwent a temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 50 days (lot # M015735) and 85 days (lot # M018436). It was reported that there was no need to repeat vaccine. No previous temperature excursion. The call was not because of a "data logger". There was no Product Quality Complaint (PQC) involved in this case. No further information was provided. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1705USA014053:
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On 27-JUL-2017, the patient was vaccinated with ZOSTAVAX lot # M027117, expiry date 26-JUL-2017 for prophylaxis. Concomitant therapies included sterile diluent. On 27-JUL-2017, the patient experienced expired product administered. On an unknown date, the patient experienced no adverse event. The outcome of expired product administered and no adverse event is unknown. The reporter considered expired product administered and no adverse event to be not related to ZOSTAVAX. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a registered nurse, refers to an unspecified patients of unknown ages and genders. On an unknown date the patient was vaccinated with VARIVAX for prophylaxis. On an unknown date the patient experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to VARIVAX.; Sender's Comments: US-009507513-1707USA011878:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a Physician refers to an unspecified number of patients of unknown age and gender. On unknown date, the patients were vaccinated with improperly stored doses of ROTATEQ oral, lot number reported as: M019690, expiration date on: 02-NOV-2017 for prophylaxis. The administered doses of the vaccine were exposed to a temperature excursions of 32 °F (degrees Fahrenheit) to 35°F (degrees Fahrenheit) for 123 hours and 31 °F (degrees Fahrenheit)  for colder for 35 hours (coldest 26 °F) A digital data logger was involved. No adverse events were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1707USA006851: US-009507513-1707USA013064:
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a Physician refers to an unspecified number of patients of unknown age and gender. On unknown date, the patients were vaccinated with improperly stored doses of PEDVAXHIB lot number: M020102, expiration date on: 09-DEC-2018. The administered doses of the vaccine were exposed to a temperature excursions of 32 °F (degrees Fahrenheit) to 35°F (degrees Fahrenheit) for 123 hours and 31 °F (degrees Fahrenheit) for colder for 35 hours (coldest 26 °F). A digital data logger was involved. No adverse events were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1707USA013063: US-009507513-1707USA006851.
Sex: M
Vaccine: PNC13
Symptoms: Injection site pain, Joint range of motion decreased, Myalgia
Clinical narrative: This is a spontaneous report from a contactable physician's assistant. A 61-year-old male patient of an unspecified race/ethnicity received PREVNAR 13, via an unspecified route of administration at single dose on 20Jul2017 for immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in Jul2017, the patient experienced arm pain at injection site, severe restriction of joint range of motion, muscle pain. The outcome of the events was unknown.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Pt. experienced redness and swelling at the site of injection as well as down left arm. Symptoms began the day after the injection. Patient came to the office on 07/31/17 to show nurses her arm.  She was instructed to use ice/heat/OTC pain relievers/Benadryl and return to the clinic if symptoms get worse.
Age: 12.0
Sex: F
Vaccine: DTAP
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: The patient was 12 years old and should have received Tdap.
Age: 20.0
Sex: F
Vaccine: UNK
Symptoms: Abdominal pain upper, Anaphylactic reaction, Anxiety, Biopsy skin abnormal, Blood calcium decreased
Clinical narrative: IHB 7550: see below: rash, chest pain, SOB after SPV.  Final dx viral exantham and anxiety.
Age: 20.0
Sex: F
Vaccine: UNK
Symptoms: Blood chloride increased, Blood glucose normal, Blood pH decreased, C-reactive protein normal, Carbon dioxide decreased
Clinical narrative: IHB 7550: see below: rash, chest pain, SOB after SPV.  Final dx viral exantham and anxiety.
Age: 20.0
Sex: F
Vaccine: UNK
Symptoms: Chest discomfort, Chest pain, Cough, Dyspnoea, Erythema
Clinical narrative: IHB 7550: see below: rash, chest pain, SOB after SPV.  Final dx viral exantham and anxiety.
Age: 20.0
Sex: F
Vaccine: UNK
Symptoms: Full blood count normal, Haematocrit decreased, Haemoglobin decreased, Heart rate increased, Hepatitis viral test negative
Clinical narrative: IHB 7550: see below: rash, chest pain, SOB after SPV.  Final dx viral exantham and anxiety.
Age: 20.0
Sex: F
Vaccine: UNK
Symptoms: Laryngitis, Lip pruritus, Lip swelling, Lipase normal, Lymphadenopathy
Clinical narrative: IHB 7550: see below: rash, chest pain, SOB after SPV.  Final dx viral exantham and anxiety.
Age: 20.0
Sex: F
Vaccine: UNK
Symptoms: Musculoskeletal pain, Nasopharyngitis, Neck pain, Nodule, Oropharyngeal pain
Clinical narrative: IHB 7550: see below: rash, chest pain, SOB after SPV.  Final dx viral exantham and anxiety.
Age: 20.0
Sex: F
Vaccine: UNK
Symptoms: PO2 increased, Pain, Papule, Rash erythematous, Rash macular
Clinical narrative: IHB 7550: see below: rash, chest pain, SOB after SPV.  Final dx viral exantham and anxiety.
Age: 20.0
Sex: F
Vaccine: UNK
Symptoms: Rash pruritic, Red blood cell count decreased, Red blood cell sedimentation rate normal, Respiratory tract congestion, Rhinorrhoea
Clinical narrative: IHB 7550: see below: rash, chest pain, SOB after SPV.  Final dx viral exantham and anxiety.
Age: 20.0
Sex: F
Vaccine: UNK
Symptoms: Sneezing, Tachycardia, Tenderness, Throat tightness, Troponin normal
Clinical narrative: IHB 7550: see below: rash, chest pain, SOB after SPV.  Final dx viral exantham and anxiety.
Age: 20.0
Sex: F
Vaccine: UNK
Symptoms: Viral rash
Clinical narrative: IHB 7550: see below: rash, chest pain, SOB after SPV.  Final dx viral exantham and anxiety.
Age: 20.0
Sex: F
Vaccine: HEPA
Symptoms: Immediate post-injection reaction, Loss of consciousness, Musculoskeletal stiffness, Seizure like phenomena, Syncope
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of seizure like phenomena in a 20-year-old female patient who received HAVRIX (batch number 9S54N, expiry date 24th July 2017). On 24th July 2017, the patient received HAVRIX. On 24th July 2017, immediately after receiving HAVRIX, the patient experienced seizure like phenomena (serious criteria GSK medically significant), fainting and stiffness. On 24th July 2017, the outcome of the seizure like phenomena, fainting and stiffness were recovered/resolved. It was unknown if the reporter considered the seizure like phenomena, fainting and stiffness to be related to HAVRIX. Additional details were provided as follows: The patient had a seizure like symptoms and was described as, she fainted, her body stiffened and she started to slide off the table. The patient regained consciousness within minutes. The patient was examined by the primary physician in the practice and no hospitalization or medical intervention was required.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Molluscum contagiosum
Clinical narrative: Mother stated molluscum contagiosum started 1 month after initial vaccine, recurred after second HPV dosage.
Age: 63.0
Sex: F
Vaccine: TDAP
Symptoms: Acne, Injection site erythema, Injection site induration, Injection site pruritus, Injection site reaction
Clinical narrative: NDC # 58160-842-43 BOOSTRIX) 0.5ml IM was given in left deltoid on 7/12/17. This prefilled syringe tip cap may contain latex; plunger contains no latex. On 7/14, patient complained of scratchy throat. Diagnosed with viral pharyngitis not thought to be related to Tdap immunization.  Given viscous lidocaine prescription swish and spit and Epipen. Patient was seen on 7/27/17 for pruritic, erthyematous hard spot described as "pimple" by the patient at the injection site of the left deltoid. MD assessed and recommended cold compresses and acetaminophen as needed. Lot # 34574; GSK product NDC 58160-842-43 with exp 5/20/19.
Age: 63.0
Sex: F
Vaccine: TDAP
Symptoms: Throat irritation, Viral pharyngitis
Clinical narrative: NDC # 58160-842-43 BOOSTRIX) 0.5ml IM was given in left deltoid on 7/12/17. This prefilled syringe tip cap may contain latex; plunger contains no latex. On 7/14, patient complained of scratchy throat. Diagnosed with viral pharyngitis not thought to be related to Tdap immunization.  Given viscous lidocaine prescription swish and spit and Epipen. Patient was seen on 7/27/17 for pruritic, erthyematous hard spot described as "pimple" by the patient at the injection site of the left deltoid. MD assessed and recommended cold compresses and acetaminophen as needed. Lot # 34574; GSK product NDC 58160-842-43 with exp 5/20/19.
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: She complained of not being able to use her arm with out it hurting, may have had a bit of a fever, but the arm pain when using is the main reason for reporting.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Borrelia test negative, Chills, Full blood count normal, Hyperhidrosis, Pain in extremity
Clinical narrative: Severe pain in my legs starting from the groins , fever with chills and profuse seating.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Severe pain in my legs starting from the groins , fever with chills and profuse seating.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Product preparation error
Clinical narrative: Patient was one of five patients who received the MENVEO vaccine from a box where a vial of diluent was found to be "left over." After making inquiries, it is impossible to tell which of the five may have received an incomplete vaccine (the MENVEO powder mixed with an incorrect diluent). After contacting the manufacturer of the vaccine to find out proper recommendations, the parents were called and asked to bring in the child for a repeat vaccination as soon as possible. There was no harmful effect from this event other than the child having to receive another shot.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Product preparation error
Clinical narrative: Patient was one of five patients who received the MENVEO vaccine from a box where a vial of diluent was found to be "left over." After making inquiries, it is impossible to tell which of the five may have received an incomplete vaccine (the MENVEO powder mixed with an incorrect diluent).  After contacting the manufacturer of the vaccine to find out proper recommendations, the parents were called and asked to bring in the child for a repeat vaccination as soon as possible. There was no harmful effect from this event other than the child having to receive another shot.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Product preparation error
Clinical narrative: Patient was one of five patients who received the MENVEO vaccine from a box where a vial of diluent was found to be "left over." After making inquiries, it is impossible to tell which of the five may have received an incomplete vaccine (the MENVEO powder mixed with an incorrect diluent). After contacting the manufacturer of the vaccine to find out proper recommendations, the parents were called and asked to bring in the child for a repeat vaccination as soon as possible. There was no harmful effect from this event other than the child having to receive another shot.