chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.25
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; tbe one patient was administered one dose of improperly stored ROTA TEQ (lot number R002805, expiration date 9/23/2019) on 8/6/2019; This spontaneous report was received from a registered nurse and refers to a 3-month-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.     On 06-AUG-2019 (also reported as 13-AUG-2019), the patient was vaccinated with improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # R002805, expiration date: 23-SEP-2019, orally (exact dose was not reported) for prophylaxis. No adverse effects were reported. The vaccine was exposed to a temperature excursion below 2 degree Celsius (C) (-2.6 degree C) for a time frame of 1 hour 4 minutes, for one cycle. The digital data logger was involved in recording the temperature excursion details. There was no previous temperature excursion.
Age: 23.0
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: she is 13 weeks pregnant after receipt ofGARDASIL 9 on 7/22/2019; no adverse reactions; This spontaneous prospective pregnancy report was received from a 23-year-old female patient who was referring to herself. She had no medical history, concomitant medication, drug reaction or allergies.   On 22-JUL-2019, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) single dose, via route reported as normal (strength, frequency, anatomical location, lot # and expiration date were not reported) for indication reported as normal vaccination.    On 14-AUG-2019 (also reported as recently), the patient found out that she was 13 weeks pregnant. Her last menstruation period (LMP) was calculated as 15-MAY-2019 and estimated due date (EDD) was calculated as 19-FEB-2020. Initial exposure to hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was at 9 weeks. The patient reported no adverse reactions. She did not seek medical attention and did not receive any treatment for the event.   The pregnancy outcome was outcome pending.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; improperly stored vaccine, ROTATEQ has been administered; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided.      On 12-AUG-2019, the patient had been administered an improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # R027191 (verified to be a valid lot number), expiration date reported and established as 15-JUL-2020, by oral route, for prophylaxis. The vaccine was improperly stored at a temperature of 29.3°F, during a time frame of 7 hours and 57 minutes. No previous temperature excursions neither adverse effects were reported. The call was because of a data logger.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-1909USA000484:
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effects reported; improperly stored MMR II was administered on 15-AUG-2019; This spontaneous report was received from a pharmacy technician and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 15-AUG-2019 (also reported as 16-AUG-2019), the patient was vaccinated with improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant Human albumin) (M-M-R II) injection, subcutaneously, lot # R027063 and expiration date 20-SEP-2020 (exact dose was not reported) for prophylaxis. The temperature was 70 F with a time frame of 4 days. There was no previous temperature excursion reported. Digital data logger was involved. No adverse effects were reported. The outcome of product storage error was unknown.   This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-1908USA007236:
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse effects reported; 13 months later for her second GARDASIL 9; This spontaneous report was received from a physician and refers to a 13-year-old female patient. No details regarding the patient's pertinent medical history, concurrent conditions and drug reactions or allergies were provided. On an unspecified date in 2018 (reported as at the age of 12 years old), the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), lot # N028567, expiration date 17-MAY-2019 (exact dose and route of administration were not provided) for prophylaxis. On 16-AUG-2019 (also reported as 13 months later), the patient was seen in the office for the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, route of administration, lot # and expiration date were not provided) for prophylaxis. No adverse effects were reported.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; improperly stored MMR II was administered on 8/14/2019; This spontaneous report was received from a pharmacy technician and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 14-AUG-2019 (also reported as 16-AUG-2019), the patient was vaccinated with improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant Human albumin) (M-M-R II) injection, subcutaneously, lot # R027063 and expiration date 20-SEP-2020 (exact dose was not reported) for prophylaxis. The temperature was 70 F with a time frame of 4 days. There was no previous temperature excursion reported. Digital data logger was involved. No adverse effects were reported. The outcome of product storage error was unknown.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-1908USA007229:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: one patient was inadvertently administered one dose of improperly stored Varivax; no adverse effects; This spontaneous report was received from a Medical Assistant and refers to a currently 4-year-old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) injection, one dose, lot # R030606 and expiration date 23-OCT-2020 (exact dose and route of administration were not reported) for prophylaxis. The temperature was in the range of -14°C to -10°C (-12.6C) for 30 minutes. There was no previous temperature excursion reported. Digital data logger was involved. No adverse effects were reported. The outcome of product storage error was unknown. No causality assessment was provided by the reporter.
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age, Product packaging confusion, Wrong product administered
Clinical narrative: No adverse effects; PQC Present?: Yes; the boxes that the vaccines come in are all blue and white and look similar; one dose of PROQUAD was inadvertently administered to the patient; This spontaneous report as received from a medical assistant refers to a 28-year-old female patient. Pertinent medical history, drug reactions and allergies were not reported.  On 20-AUG-2019, the patient was inadvertently vaccinated with one dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot number: S012472, expiration date: 20-OCT-2020, albumin status: rHA; dose was not reported) administered subcutaneously diluted in sterile diluent (wrong product administered). It was reported that the boxes the vaccines come in were all blue and white and looked similar (product packaging confusion). Product quality complaint (PQC) was filled. No adverse effects were reported.  The outcome of PQC was unknown.  The relatedness between PQC and the vaccine was not reported.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: reporting the patient was inadvertently administered a dose ofROTATEQ that had been improperly stored.; No adverse effect; This spontaneous report was received from a Medical Assistant who referred to a patient of unknown age and gender. The patient's pertinent medical history, concomitant therapies, as well as drug reactions or allergies were not provided.   On an unknown date, the patient was inadvertently administered with  an improperly stored dose (product storage error) of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), orally for prophylaxis (strength, frequency not provided)(lot number S000961 and R033255 have been verified to be valid lot numbers; expiration dates: 19-OCT-2020 and 26-JUN-2020, respectively). The  temperature  excursion was at 48.5 degrees Fahrenheit (F) , for a time frame of 15 minutes, and  the previous temperature excursion was at 46.9 F for a timeframe of 5 minutes. It was reported that the call was due to data logger. No adverse effects were reported.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; administered a dose of ROTATEQ that had been improperly stored; This spontaneous report has been received from a medicall assistant, regarding to a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant medications were not reported.   On 21-AUG- 2019, the patient was vaccinated with an improperly stored dose (Product storage error) of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ), orally,  (lot number S000961 and R033255 have been verified to be valid lot numbers; expiration dates: 19-OCT-2020 and 26-JUN-2020, respectively; however, it was not specified if a second dose was given) administered as prophylaxis. (strengths, dose and frequency were not reported).  On 21- AUG- 2019 Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) was stored at a temperature of 48.5 degrees Fahrenheit  for the time frame of 15 minutes with a previous temperature excursion  at 46.9 F for a time frame of 5 minutes. It was reported that the call was due to Data logger. No adverse effects were reported.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; The patient inadvertently received second dose in PROQUAD immunization serious that had post its expiration date; Information has been received from a licensed practical nurse referring to a 4-year-old patient of unknown gender. The patient's pertinent medical history, concurrent condition and concomitant therapy were not reported.        On 22-AUG-2019, the patient was inadvertently vaccinated with expired 2nd dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # R004439, expiration date: 12-AUG-2019) 0.5 milliliter reconstituted with sterile diluent (Lot # N030179, expiration date: 03-JUL-2020, not expired) (route of administration not reported) once for prophylaxis during the immunization serious. The date for the 1st vaccination was not provided. No adverse effects reported. Correspondence to nurse. No further information provided.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   On or about 03-MAR-2010, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions.   On an unspecified date, the patient experienced shingles which lead to hospitalization. On an unspecified date, the patient was treated by a healthcare provider for shingles. As a direct and proximate result of the patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future.   The outcome of the event shingles was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).   Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer and the patient regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided.  In 2014, the patient (pt) was vaccinated with zoster vaccine live (ZOSTAVAX), (lot# and route unknown) for long-term prevention of shingles and zoster-related conditions.  Subsequent to zoster vaccine live (ZOSTAVAX) inoculation, the pt experienced shingles (date unspecified) and was treated by a physician at a her office, and was hospitalized due to the event (date unspecified). As a direct and proximate result of pt use of the zoster vaccine live (ZOSTAVAX) vaccine, the pt had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the event was considered as not resolved. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On 10-FEB-2015, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (lot number, dosage and route of administration not provided) at pyharmacy, for the long term prevention of shingles and zoster related conditions. Subsequently, the patient was treated by a healthcare professional at the patient place, since she experienced shingles on unspecified date. As a direct and proximate result of the patient's use of zoster vaccine live (ZOSTAVAX) vaccine, the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the event was not provided and the causality of the events was related.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided.  In 2008, the patient (pt) was vaccinated with zoster vaccine live (ZOSTAVAX), (lot# and route unknown) for long-term prevention of shingles and zoster-related conditions.  Subsequent to zoster vaccine live (ZOSTAVAX) inoculation, the pt experienced shingles and was treated by a healthcare provider at the emergency room; and was hospitalized due to the event (date unspecified). As a direct and proximate result of pt use of the zoster vaccine live (ZOSTAVAX) vaccine, the pt had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of the event was reported as not resolved.  The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided.  On or about 10-OCT-2011, the patient (pt) was vaccinated with zoster vaccine live (ZOSTAVAX), (lot# and route unknown) for long-term prevention of shingles and zoster-related conditions.  Subsequent to zoster vaccine live (ZOSTAVAX) inoculation, the pt experienced shingles (date unspecified) and was treated by a physician at her office, and was hospitalized due to the event (date unspecified). As a direct and proximate result of pt use of the zoster vaccine live (ZOSTAVAX) vaccine, the pt had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the event was considered as not resolved. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia, Rash, Rash vesicular
Clinical narrative: painful blistering rash on her abdomen and back/ diagnosed with Herpes Zoster; post herpetic neuralgia; Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (lot number, dosage and route of administration not provided), at a pharmacy for the long term prevention of shingles and zoster related conditions. Subsequently, the patient suffered a painful blistering rash on her abdomen and back. As a result of these symptoms, the pt went to medical provider and was diagnosed with herpes zoster and postherpetic neuralgia. As a direct and proximate result of the patient's use of zoster vaccine live (ZOSTAVAX) vaccine, the patient had and would continue suffer significant medical expenses, pain and other damages. The causality between the events and zoster vaccine live (ZOSTAVAX) was considered as related. Additional information has been requested.
Age: 9.0
Sex: F
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: the patient experienced syncope post administration with GARDASIL; Information has been received from a nurse referring to a 9 years old female patient. Information of concomitant therapy, pertinent medical history and drug reactions/allergies was not reported.  On 23-AUG-2019, the patient received hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # R032768, expiration date: 31-AUG-2021, strength, dose and frequency were unknown) intramuscularly for prophylaxis. She experienced syncope post administration with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). On the same day, the event was resolved.  The causality between syncope and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not reported.  Upon internal review, syncope was determined to be medically significant.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report as received from a lawyer refers to a male patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 09-JUL-2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route of administration not specified) for the long-term prevention of shingles and zoster-related conditions at a pharmacy. On an unknown date, the patient was treated by a physician for shingles. As a direct and proximate result of the zoster vaccine live (ZOSTAVAX),the patient suffered and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of shingles was unknown. The reporter considered shingles to be related to Zoster Vaccine Live (ZOSTAVAX).
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; Patient received unspecified dose of Pedvaxhib that was improperly stored; This spontaneous report was received from a Registered Nurse and was referring to a patient of unknown age. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies were not reported.   On 10-MAY-2018, haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB), lot # N003536, expired date in November 2019, was storage out of the recommended range at 8.72 Celsius Degrees during 1h 35 minutes (total time including previous temperature excursions).  On 02-JUL-2018, the patient was vaccinated with an improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB), lot # N003536, expired date in November 2019, (strength, dose, frequency, route, and anatomical location were not reported), for prophylaxis. The digital datalogger was involved. No adverse effects were reported.
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling
Clinical narrative: injection site swelling; This spontaneous report was received from a physician refers to a 51 year old female patient. The patient was diabetic and was having allergy/reaction (unspecified) to glyburide. Concomitant therapies included insulin human(HUMULIN).   On 28-AUG-2018, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (strength and dose were not reported) (lot # S012822 has been verified to be a valid lot number with expiration date 21-FEB-2021) via intramuscular route for prophylaxis. After receiving vaccination, the patient experienced injection site swelling. It was reported that the injection site swelling went away after rubbing the area (recovered/resolved) on the same day. The reporter's causality assessment was not reported. No product quality complaint was reported.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; An improperly stored dose of GARDASIL 9 was administered; This spontaneous report was received from a nurse concerning to a patient of unknown age and gender. The patient medical history, concurrent conditions and concomitant medications were not reported.  On 28-AUG-2019, the patient was vaccinated with a dose of improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) for prophylaxis (strength, dose, route of administration and frequency were no reported) (lot # 1614897 has been verified to be a valid lot number for stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast), expiration date reported and establish as 20-SEP-2021).  The administered dose of the vaccine experienced a temperature of 48.5 Fahrenheit for 4 hour and 15 minutes. There was a digital data logger involved, but there was no previous temperature excursion. No adverse effect was reported.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: patient received improperly stored vaccine on 4/16/2019; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's concurrent conditions, past medical history and concomitant medications were not reported.  On 16-APR-2019, the patient was vaccinated with an improperly dose of an measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) lot # R030799 and expiration date 22-APR-2020 (dose number, frequency and route were not provided) for prophylaxis (product storage error). The administered dose of the vaccine was stored with a temperature of 9.9 degrees Fahrenheit for 57 minutes and a previous temperature excursion of  28.9 degrees Fahrenheit for 5 hours and 30 minutes. There was a digital data logger involved.
Sex: U
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: a patient received improperly stored vaccine; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided.  The reporter stated that 23-APR-2019, the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated(VAQTA) one dose, for prophylaxis, lot # S002459, expiration date: 15-MAY-2020, (frequency and route were not provided) (product storage error). It was stated that the vaccine was under a temperature excursion of 52.5 F, during 4 hours 40 minutes. There was not previous temperature excursion. Data logger was positive.
Sex: U
Vaccine: HIBV
Symptoms: Product storage error
Clinical narrative: a patient received improperly stored vaccine on 15-APR-2019; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant and historical drugs was not provided.  On 15-APR-2019, the patient was vaccinated with an improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) lot # R021078, expiration date 12-JUN-2021 (strength, route and anatomical location were not provided) for prophylaxis. The vaccine was exposed to a temperature of 52.5 degree Fahrenheit, for 4 hours and 40 minutes. There was not previous temperature excursion. It was reported that digital data logger was involved.
Sex: F
Vaccine: HPV9
Symptoms: Pyrexia
Clinical narrative: Patient experienced a 104 degree fever 12 hours after GARDASIL 9 was administered; This spontaneous report was received from a physician via company representative referring to a non-pregnant female patient of unknown age. The patient's concurrent conditions, past medical history and concomitant medications were not reported.   On an unspecified date in August 2018, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) intramuscularlly (dose number, frequency, lot/batch # and expiration date) for prophylaxis. In approximately August 2018 (reported as approximately one year ago), the patient experienced a 104 degree fever 12 hours after hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) injection (pyrexia). It was unknown if treatment was given for the event. The outcome of pyrexia was reported as recovered (date was not reported).    The causality assessment between the event and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was not provided.
Sex: F
Vaccine: HEPA
Symptoms: Rash
Clinical narrative: a patient who received a dose ofVAQTA on an unknown date from an unspecified provider, and developed a rash 7 days later.; This spontaneous report was received from a physician refers to a currently 33 years old female patient. The patient had no medical history, no concurrent conditions, no concomitant medications and no drug reactions or allergies.     On an unknown date, the patient was vaccinated with a dose of hepatitis a vaccine, inactivated(VAQTA), intramuscular route of administration, for prophylaxis (strength, dose, frequency, route, lot number and expiration date were not provided).         On an unknown date, 7 days after onset of therapy the patient developed rash. However, it was reported that the patient sought medical attention but no treatment was prescribed.      At the time of reporting, the outcome of rash was reported as not resolved.      The causal relationship between hepatitis a vaccine, inactivated(VAQTA) and the reported rash was not provided.
Sex: U
Vaccine: HIBV
Symptoms: Product storage error
Clinical narrative: patient received improperly stored vaccine on 4/16/2019.; This spontaneous report was received from a medical assistant, concerning a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions or allergies were not reported.   On 16-APR-2019, the patient received one improperly stored dose of haemophilus B conjugate vaccine (meningococcal protein conjugate) (PEDVAXHIB), lot # R021078 and expiration date on 12-JUN-2021, for prophylaxis (route of administration and anatomical location were not reported).  The administered dose of the vaccine had a temperature excursion of 52.5 Fahrenheit degrees (°F) for 4 hours and 40 minutes, as recorded by a digital data logger. The vaccine had not had previous temperature excursions. No product quality complaint was involved.
Sex: U
Vaccine: MMRV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: vaccine was administered outside the administration guideliness; This spontaneous report was received from a medical assistant referring to a 15 year old patient, of unknown gender.  No other information was provided regarding the patient's medical history or drug reactions/allergies.  Concomitant therapies included sterile diluent (STERILE DILUENT).      On an unspecified date, the patient was vaccinated with one dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) for prophylaxis, outside the administration guidelines according to the prescribing information.  At the time of the report, the patient's outcome was unknown.
Sex: U
Vaccine: HIBV, RV5
Symptoms: Product storage error
Clinical narrative: patient received improperly stored vaccine on 4/25/2019; This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. The patient's pertinent medical history, concomitant therapies, drug reactions and allergies were not provided.  On 25-APR-2019, the patient was vaccinated with improperly stored one dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (lot # R021078, expiry date 12-JUN-2021; injection site and route of administration were not provided) and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally (lot # R028189, expiry date 06-JUN-2020; exact dose and injection site were not reported), both for prophylaxis. The vaccines were exposed to the temperature of 52.5 degrees Fahrenheit (F) for 4 hours and 40 minutes. There was no previous temperature excursion. Digital data logger was involved.
Sex: U
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: patient received improperly stored vaccine on 4/24/2019; This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. The patient's pertinent medical history, concomitant therapies, drug reactions and allergies were not provided.  On 24-APR-2019, the patient was vaccinated with improperly stored one dose of hepatitis a vaccine, inactivated (VAQTA) (lot # S002459, expiry date 15-MAY-2020; injection site and route of administration were not reported) for prophylaxis. The vaccine was exposed to the temperature of 52.5 degrees Fahrenheit (F) for 4 hours and 40 minutes. There was no previous temperature excursion. Digital data logger was involved.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; patients have been administered doses of vaccine which were improperly stored; This non-valid spontaneous report was received from a healthcare worker referring to unspecified number of patients of unknown age and gender. No information regarding the patients' pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On unknown dates (reported as since 29-NOV-2018), the patients were vaccinated with improperly stored doses of hepatitis b vaccine (recombinant)(RECOMBIVAX HB)(therapy types, exact doses, injection sites, routes of administration, lot numbers and expiration dates were not provided), hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9))(exact doses, injection sites, routes of administration, lot numbers and expiration dates were not provided), hepatitis a vaccine, inactivated (VAQTA) )(exact doses, injection sites, routes of administration, lot numbers and expiration dates were not provided) and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally (exact doses, injection sites, lot numbers and expiration dates were not provided) for prophylaxis. Administered doses of vaccines experienced the temperature excursions of 47 degrees Fahrenheit to 77 degrees Fahrenheit (48.2 degrees Fahrenheit) for 13 minutes. The digital data logger was involved in recording the temperature excursion details. No previous temperature excursion had occurred. No adverse effects were reported.  This is a non-valid report due to lack of the patients' identifiers.  Follow-up information was received from the healthcare worker on 30-AUG-2019.   On 30-AUG-2019, a phone call was placed to the reporter. The phone call was answered by the medical assistant. The medical assistant stated that she would additional need time to conduct her research on the patient(s) who were administered the vaccines. A request was made for patient identifiers, lot and vaccine received and on what date. The company contact information was shared.  Additional information has been requested.  The patient's identifiers were provided. The reporter referred to a patient of unknown age and gender.  On 30-NOV-2018, the patient was vaccinated with a dose of improperly stored hepatitis b vaccine (recombinant) thimerosal-free (RECOMBIVAX HB) lot number R004185, expiration ate was not provided, but upon an internal verification was established on 06-NOV-2020 (exact dose, injection site and route of administration were not reported) for prophylaxis. Excursion of 29-NOV-2018 when the refrigerator temperature dropped was of 45.7 degrees Fahrenheit to 48.2 degrees Fahrenheit for 13 minutes.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1812USA002508: US-009507513-1909USA000371:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; patients have been administered doses of vaccine which were improperly stored; This non-valid spontaneous report was received from a healthcare worker referring to unspecified number of patients of unknown age and gender. No information regarding the patients' pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On unknown dates (reported as since 29-NOV-2018), the patients were vaccinated with improperly stored doses of hepatitis b vaccine (recombinant)(RECOMBIVAX HB)(therapy types, exact doses, injection sites, routes of administration, lot numbers and expiration dates were not provided), hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9))(exact doses, injection sites, routes of administration, lot numbers and expiration dates were not provided), hepatitis a vaccine, inactivated (VAQTA) )(exact doses, injection sites, routes of administration, lot numbers and expiration dates were not provided) and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally (exact doses, injection sites, lot numbers and expiration dates were not provided) for prophylaxis. Administered doses of vaccines experienced the temperature excursions of 47 degrees Fahrenheit to 77 degrees Fahrenheit (48.2 degrees Fahrenheit) for 13 minutes. The digital data logger was involved in recording the temperature excursion details. No previous temperature excursion had occurred. No adverse effects were reported.  This is a non-valid report due to lack of the patients' identifiers.  Follow-up information was received from the healthcare worker on 30-AUG-2019.   On 30-AUG-2019, a phone call was placed to the reporter. The phone call was answered by the medical assistant. The medical assistant stated that she would additional need time to conduct her research on the patient(s) who were administered the vaccines. A request was made for patient identifiers, lot and vaccine received and on what date. The company contact information was shared.  Additional information has been requested.  The patient's identifiers were provided. The reporter referred to a patient of unknown age and gender.  On 03-DEC-2018, the patient was vaccinated with a dose of improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally, lot number R012954, expiration ate was not provided, but upon an internal verification was established on 04-DEC-2019 (exact dose was not reported) for prophylaxis. Excursion of 29-NOV-2018 when the refrigerator temperature dropped was of 45.7 degrees Fahrenheit to 48.2 degrees Fahrenheit for 13 minutes.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1812USA002508: US-009507513-1909USA000370:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; improperly stored vaccine, ROTATEQ has been administered; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided.      On 12-AUG-2019, the patient had been administered an improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # R027191 (verified to be a valid lot number), expiration date reported and established as 15-JUL-2020, by oral route, for prophylaxis. The vaccine was improperly stored at a temperature of 29.3°F, during a time frame of 7 hours and 57 minutes. No previous temperature excursions neither adverse effects were reported. The call was because of a data logger.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-1908USA006617:
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Insomnia, Pain in extremity
Clinical narrative: pain in arm; insomnia/ not sleeping/ Sleep a little; been wired; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included hypothyroidism. Concomitant products included levothyroxine sodium (Synthroid).   On 16th August 2019, the patient received the 1st dose of Shingrix. In August 2019, less than a day after receiving Shingrix, the patient experienced pain in arm, insomnia and feeling abnormal. On an unknown date, the outcome of the pain in arm, insomnia and feeling abnormal were unknown.   It was unknown if the reporter considered the pain in arm, insomnia and feeling abnormal to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient's husband.  The patient reported that the night of her first injection she had pain in her arm, but that was expected.  The first two nights she stated that she was able to sleep a little but since 17th August 2019, she had been wired, had insomnia and not sleeping. The reporter did not consent to follow-up. The case has been linked to the case US2019152138, reported by same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Pain, Pain in extremity
Clinical narrative: injection site soreness; Hurt to move arm; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix .5 ml. On an unknown date, less than 6 months after receiving Shingrix, the patient experienced injection site pain and pain in arm. On an unknown date, the outcome of the injection site pain and pain in arm were recovered/resolved.   It was unknown if the reporter considered the injection site pain and pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported but it could be between 51 or 52 years. The age group was not reported but was selected as per the vaccine indication. The patient experienced injection site soreness and hurt to move her arm for a week. The patient consented to follow up. This case has been linked with cases US2019153955, US2019153962, US2019153964, US2019153966, reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus
Clinical narrative: Redness / erythema; pruritis; This case was reported by a pharmacist and described the occurrence of localized erythema in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced localized erythema and localized itching. On an unknown date, the outcome of the localized erythema and localized itching were recovered/resolved.   It was unknown if the reporter considered the localized erythema and localized itching to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received 1st dose of Shingrix and had a significant localized reactions of redness/ erythema and pruritus, which lasted for 1 week. The patient was concerned about receiving her 2nd dose. Per the package insert, these events did occur in 1% of patients receiving Shingrix, but wondering if there was any information to support that this may lead to a more significant and/or allergic response when the 2nd dose would be given.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Inflammation, Influenza like illness, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Soreness; Swelling; Redness; inflammation; flu like; ichy; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (received 1st dose approximately 2 months ago, refer case US2019154061).   In August 2019, the patient received the 2nd dose of Shingrix. In August 2019, less than 2 weeks after receiving Shingrix, the patient experienced injection site pain, injection site swelling, injection site erythema, inflammation, influenza-like symptoms and injection site itching. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site pain, injection site erythema, inflammation and influenza-like symptoms were recovered/resolved and the outcome of the injection site swelling was not recovered/not resolved and the outcome of the injection site itching was unknown.   It was unknown if the reporter considered the injection site pain, injection site swelling, injection site erythema, inflammation, influenza-like symptoms and injection site itching to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in the left arm. The patient experienced inflammation, soreness, swelling, and redness as significantly worse compared to 1st dose. The patient had some sort of flu. The patient reported a bumpy, raised spot at injection site that looks like it contains blisters but it was not. The patient did not consent to follow up.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Injection site swelling, Vaccine positive rechallenge
Clinical narrative: Soreness; Swelling; Redness; inflammation; flu like; ichy; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (received 1st dose approximately 2 months ago, refer case US2019154061).   In August 2019, the patient received the 2nd dose of Shingrix. In August 2019, less than 2 weeks after receiving Shingrix, the patient experienced injection site pain, injection site swelling, injection site erythema, inflammation, influenza-like symptoms and injection site itching. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site pain, injection site erythema, inflammation and influenza-like symptoms were recovered/resolved and the outcome of the injection site swelling was not recovered/not resolved and the outcome of the injection site itching was unknown.   It was unknown if the reporter considered the injection site pain, injection site swelling, injection site erythema, inflammation, influenza-like symptoms and injection site itching to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in the left arm. The patient experienced inflammation, soreness, swelling, and redness as significantly worse compared to 1st dose. The patient had some sort of flu. The patient reported a bumpy, raised spot at injection site that looks like it contains blisters but it was not. The patient did not consent to follow up.