chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 33.0
Sex: M
Vaccine: PPV
Symptoms: Joint range of motion decreased, Limb injury, Vaccination complication
Clinical narrative: This spontaneous report was received from an office manager and refers to a 33-year-old male patient. The patient's pertinent medical history included pneumonia and concomitant medications included prednisone (manufacturer unknown) and doxycycline (reported as "doxycyline"). The patient had no drug reactions or allergies. On 20-NOV-2017, the patient was vaccinated with a dose of PNEUMOVAX 23 (dose, frequency and route of administration were not reported) lot # N025656 with expiration date: 19-APR-2019. On 20-NOV-2017, 3 hours after vaccination, the patient experienced shoulder injury related to vaccine administration (SIRVA) and limited range of motion. The patient called the physician's office on 21-NOV-2017 and the office referred him to "see an unspecified orthopedist". No treatment was provided however it was also reported that the patient received the treatment. The outcome of SIRVA and limited range of motion was reported as not recovered at the time of this report. The event of SIRVA was reported as related to Pneumococcal Vaccine, Polyvalent (23-valent)(PNEUMOVAX23). The relatedness between limited range of motion and PNEUMOVAX 23 was not reported.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site reaction, Injection site warmth, Pain, Rash erythematous, Skin warm
Clinical narrative: This spontaneous report was received from a physician and a medical assistant referring to a 66 year old non-pregnant female patient. The patient's medical history, drug reactions/allergies and concomitant medications were not provided. On 21-NOV-2017, the patient was vaccinated with PNEUMOVAX 23 0.5 ml, intramuscular route in the arm, for prophylaxis; lot # N020501, expiration date: 03-MAR-2019 (previously reported as NO23651 with expiration date in May 2019). Lot number NO23651 was an invalid lot number for pneumococcal vaccine, polyvalent (23-valent). On 22-NOV-2017, the patient experienced red-ringed rash with fever at the injection site as reported by the physician. On the same date, the patient experienced swelling, warmth and pain, as reported by the medical assistant. The patient sought medical attention and the physician advised the patient to take an unspecified dose of the over-the-counter antihistamine ZYRTEC as treatment (it was unknown if the patient took the treatment), on the other hand, the medical assistant reported that no prescription drug treatment was required for the experience. No product quality complaint was involved. The outcome of injection site rash and pyrexia was unknown. The injection site erythema, swelling and erythema went away on 26-NOV-2017. The warmth and pain went away on 29-NOV-2017. The causality assessment between the PNEUMOVAX 23 and the aforementioned adverse events was not reported. The physician reported a similar adverse event for another patient who received PNEUMOVAX 23 with the same lot and expiration date.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Swelling
Clinical narrative: This spontaneous report was received from a physician and a medical assistant referring to a 66 year old non-pregnant female patient. The patient's medical history, drug reactions/allergies and concomitant medications were not provided. On 21-NOV-2017, the patient was vaccinated with PNEUMOVAX 23 0.5 ml, intramuscular route in the arm, for prophylaxis; lot # N020501, expiration date: 03-MAR-2019 (previously reported as NO23651 with expiration date in May 2019). Lot number NO23651 was an invalid lot number for pneumococcal vaccine, polyvalent (23-valent). On 22-NOV-2017, the patient experienced red-ringed rash with fever at the injection site as reported by the physician. On the same date, the patient experienced swelling, warmth and pain, as reported by the medical assistant. The patient sought medical attention and the physician advised the patient to take an unspecified dose of the over-the-counter antihistamine ZYRTEC as treatment (it was unknown if the patient took the treatment), on the other hand, the medical assistant reported that no prescription drug treatment was required for the experience. No product quality complaint was involved. The outcome of injection site rash and pyrexia was unknown. The injection site erythema, swelling and erythema went away on 26-NOV-2017. The warmth and pain went away on 29-NOV-2017. The causality assessment between the PNEUMOVAX 23 and the aforementioned adverse events was not reported. The physician reported a similar adverse event for another patient who received PNEUMOVAX 23 with the same lot and expiration date.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX, lot # N010108, expiration date: 20-MAR-2019, for prophylaxis (dose #, route and anatomical location of administration were unknown). The dose was stored from -14 Celsius degrees (C) to -10 C (-14.1 C) for 76 minutes, from -9 C to 8 C (-8.7 C) for 103 minutes, and from -14 C to -10 C (-11.2 C) for 11 hours. The temperature excursion was detected by a data logger. The sterile diluent (manufacturer unknown) used for reconstitution was properly stored. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1712USA006541: US-009507513-1712USA006542: US-009507513-1712USA006543: US-009507513-1712USA006544: US-009507513-1712USA006545.
Age: 0.08
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a medical assistant referring to a 1 month old patient of unknown gender. Information about concurrent condition, drug reactions/allergies, concomitant therapies and medical history was unknown. On 27-NOV-2017, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB (lot # M036156 with expiration date 23-FEB-2019, 1 dose, strength unknown) intramuscularly for prophylaxis. The vaccine was exposured at the temperature of 55.2 Fahrenheit (47 to 77 Fahrenheit) for 2 hours and 41 minutes. No adverse effect was reported. There was no previous temperature excursion. A data logger was involved. This is one of 4 reports received from the same reporter. Sender's Comments: US-009507513-1712USA005651: US-009507513-1712USA005650: US-009507513-1712USA005649.
Sex: M
Vaccine: RV5
Symptoms: Vomiting
Clinical narrative: This spontaneous report was received from a pharmacist referring to a male patient of unknown age. On 28-NOV-2017, the patient was vaccinated with a dose of ROTATEQ, oral (dose, lot number and expiration date not reported) for prophylaxis. The pharmacist reported 15 minutes after administration of the ROTATEQ patient "threw up". It was unknown which dose in the series of ROTATEQ was received. The outcome of the event was unknown. The reporter did not assess the causality.
Age: 0.58
Sex: U
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a 7 month old patient of unknown gender. The patient's concurrent condition, concomitant therapy and medical history were unknown.     On 28-NOV-2017, the patient was vaccinated with a first dose of VAQTA (lot # N019924, expiration date: 02-SEP-2018, intramuscular, dose and frequency were unknown) for prophylaxis at 7 months of age(Inappropriate age at vaccine administration). No adverse effects were reported.
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This spontaneous retrospective pregnancy report as received from a nurse referring to a female patient of unknown age. The patient's concurrent condition, concomitant therapy and medical history were unknown. On an unknown date, the patient was vaccinated with GARDASIL 9 (dose, frequency and route were unknown, lot # M028323, expiration date: 26-SEP-2018) for prophylaxis. The nurse reported it was unknown which dose in the GARDASIL 9 vaccination series was administered while the patient was pregnant(maternal exposure during pregnancy). The last mentrual period (LMP) and estimated date of delivery (EDD) was not known. On 30-OCT-2017, the patient delivered a baby (at unspecified hospital and unspecified location) without any side effects. The patient was no longer pregnant as of the time of report. The outcome of maternal exposure during pregnancy was recovered.
Sex: U
Vaccine: HIBV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 16 year old patient of unknown gender. The patient's concomitant medications, pertinent medical history, drug reactions or allergies were not reported. On 21-NOV-2017, the patient was inadvertently vaccinated with PEDVAXHIB 0.5 ml, intramuscularly, (lot # L035878, expiration date: 11-AUG-2018). There was no adverse event reported.
Age: 1.0
Sex: F
Vaccine: HPV9
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 1 year old female patient. The patient's pertinent medical history, drug reactions, allergies and concomitant therapy were not reported. On 30-NOV-2017, the one year old patient inadvertently received a dose of GARDASIL 9, intramuscular for prophylaxis. No adverse effects were reported in the patient. The patient sought medical attention but no Intervention to prevent serious criteria was performed.
Sex: M
Vaccine: PPV
Symptoms: Dizziness, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: This spontaneous report as received from a healthcare professional refers to a 79 year old male patient. In 2016, the patient was vaccinated with a first dose of PNEUMOVAX 23. On 27-NOV-2017, the patient was vaccinated with a second dose of PNEUMOVAX 23 (dose, route and site of administration were not reported) for prophylaxis. In approximately 2017, the patient experienced an injection site issue - red, sore, hot arm like cellulitis as well as dizziness. On an unknown date, the patient experienced dizziness. The symptoms did subside without intervention, however the overall outcome of events was unknown.
Age: 69.0
Sex: F
Vaccine: PNC, PPV
Symptoms: Fall, Pneumonia
Clinical narrative: This spontaneous report was received from a 69 year old female patient consumer referring to herself. The patient's current conditions included: bipolar disorder, additionally the patient's concomitant therapy included an unknown number of medications for treatment of bipolar disorder. The patient's allergies and drug reactions included: alfentanil (manufacturer unknown), codeine (manufacturer unknown) and Penicillin (manufacturer unknown). On unknown date in November 2017, the patient started therapy with BELSOMRA oral, tablet (dose, frequency, lot number and expiration date were not reported) for insomnia. On 27-NOV-2017 the patient fell down, went to the emergency room and sought medical attention. The patient was diagnosed with pneumonia and subsequently she was admitted to a medical center. She was discharge on 30-NOV-2017. The patient was treated with ZITHROMAX and MUCINEX. Therapy with BELSOMRA was continued. The outcome of pneumonia and fall was reported as not recovered. The reporter did not assess the causal relationship between therapy with BELSOMRA and the aforementioned events. Upon internal review the event of pneumonia was considered to be medically significant event. Follow-up information has been received from a consumer on 08-DEC-2017. The patient's allergies and drug reactions included: fentanyl, NEURONTIN and ampicillin. On an unspecified date, the patient received a second unspecified "pneumonia shot" Pneumococcal Vaccine, Polyvalent (23-valent) (manufacturer unknown) (formulation,strength, dose, frequency, route, indication, lot# and expiration date were not provided). Also, on an unspecified date, the patient was vaccinated with PREVNAR for sleep (formulation, strength, dose, frequency, route, lot# and expiration date were not provided). The causality between the events and Pneumococcal Vaccine, Polyvalent (23-valent) (manufacturer unknown) was not provided. The reporter considered the pneumonia as disabling.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative refers to a female patient of unknown age (the reporter's wife). Information regarding the patient's pertinent medical history, drug reactions or allergies was unknown. On an unknown date, approximately in 2015 (reported as 2 and a half years ago), the patient was vaccinated with ZOSTAVAX (dose, route of administration, lot# and expiration date were not reported) for prophylaxis. On an unknown date, approximately in 2015 (reported as 15 days after vaccination), the patient developed herpes zoster in the head region. On an unknown date, the patient started to experience post herpetic neuralgia. The patient sought medical attention by visiting multiple pain specialists on unknown dates, however it was unknown if she received any treatment for the events. It was unknown if the patient had shingles rash at the reporting time. She had not recovered from post herpetic neuralgia till the time of the report. Causality assessment was not provided.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's concurrent conditions, concomitant medications, pertinent medical history and drug reactions or allergies were not provided. On 01-DEC-2017, the patient was administered an improperly stored dose of GARDASIL 9 injection, lot # N015089 with expiration date on 20-OCT-2019 (dose and route of administration were not reported). The administered dose of vaccine underwent a temperature excursion of 47.6 degrees Fahrenheit, which lasted for an unspecified time. There was no previous temperature excursion. A digital data logger was not involved in recording the excursion. No adverse effects were reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1712USA008157: US-009507513-1712USA008158: US-009507513-1712USA008159: US-009507513-1712USA008160: US-009507513-1712USA008161: US-009507513-1712USA008162:
Sex: U
Vaccine: HEP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a physician and refers to a newborn patient of unknown gender. There was no information about the patient's concomitant medications, concurrent conditions or pertinent medical history reported. On 02-DEC-2017, the patient was vaccinated with a dose of RECOMBIVAX HB (exact dose, route of administration, lot# and expiry date were not reported) for prophylaxis after receiving a dose of RECOMBIVAX HB on 01-DEC-2017. No adverse effects were reported.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse prescriber and refers to a patient of unknown age and gender. There was no information regarding the patient's medical history, concomitant medications, drug reactions and allergies provided. On 05-DEC-2017, the patient was vaccinated with expired dose of VARIVAX, subcutaneously for prophylaxis (lot number: L037559, expiration date 29-SEP-2017). The vaccine was reconstituted with sterile diluent (lot number: N022038, expiration date 27-NOV-2019). No adverse effects were reported.
Sex: F
Vaccine: PPV
Symptoms: Headache, Peripheral swelling, Rash
Clinical narrative: This spontaneous report was received from a consumer and refers to a female patient of unknown age. The patient was allergic to sulfa drugs and unknown antibiotics. No information regarding the patient's medical history or concomitant medications was provided. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (strength, dose, route of administration, lot # and expiration date were not reported) to prevent pneumonia. On an unknown date, after receiving the vaccine, the patient experienced headache, swollen arm and rash no legs. No lab test were performed. The patient did not seek medical attention. An unspecified treatment was given for the adverse events. The outcome of all adverse events was reported as not recovered/not resolved. The relatedness between all adverse events and PNEUMOVAX 23 was not reported.
Age: 0.17
Sex: U
Vaccine: HIBV, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from an administrator and refers to a patient of unknown age and gender. The patient's concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 28-NOV-2017, the patient was vaccinated with an improperly stored dose of ROTATEQ orally, (dose and frequency were not reported) lot # M044397 with expiration date: 20-JUN-2018 or lot# N003984 with expiration date: 19-NOV-2018, for prophylaxis. On 28-NOV-2017, the patient was also vaccinated with an improperly stored dose of PEDVAXHIB (dose, frequency and route of administration were not reported) with lot # reported as N047666 with expiration date 24-OCT-2019 or lot# M045206 with expiration date 27-JUN-2019 or lot # N001348 with expiration date 31-OCT-2019 with expiration date 31-OCT-2019 or lot # N008080 with expiration date 02-DEC-2019. The specific lots # of ROTATEQ and PEDVAXHIB administered to the patient was unknown by reporter. The ROTATEQ vaccine and PEDVAXHIB were stored in or above 32 degrees Fahrenheit (F) up to 35 F (35.4 F) for 45 minutes. There was no previous temperature excursion. The digital data logger was involved in recording the temperature excursion. No adverse effects were reported. This is one of seven reports received from the same reporter. The lot # N047666 has been verified to be not valid for PEDVAXHIB. Sender's Comments: US-009507513-1712USA002785: US-009507513-1712USA002197: US-009507513-1712USA002303: US-009507513-1712USA002524: US-009507513-1712USA002652: US-009507513-1712USA002696.
Sex: U
Vaccine: PPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a physician and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. In April 2017, the patient was vaccinated with a dose of PNEUMOVAX 23 (dose, route of administration, lot# and expiration date were not reported). On 06-DEC-2017, the patient was inadvertently administered a second dose of PNEUMOVAX 23 (dose, route of administration, lot# and expiration date were not reported). There were no adverse effects reported.
Sex: F
Vaccine: PPV
Symptoms: Injection site hypoaesthesia, Injection site pain, Injection site paraesthesia
Clinical narrative: This spontaneous report was received from a nurse practitioner via a company representative and refers to a female patient of unknown age. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX 23 injection (dose, frequency, route of administration, lot# and expiration date were not reported). On an unknown date, the patient experienced numbness, tingling, and pain at the injection site. The patient sought medical attention and on 02-DEC-2017 called the nurse practitioner. The outcome of numbness, tingling, and pain at the injection site was unknown. The relatedness between the events and therapy with PNEUMOVAX 23 was not reported. This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-1712USA004514:
Sex: F
Vaccine: HPV9
Symptoms: Rash pruritic
Clinical narrative: This spontaneous report was received from a physician via a company representative and refers to a non-pregnant, 13 or 14 years old female patient. The patient's concurrent conditions, concomitant medications, pertinent medical history and drug reactions or allergies were not provided. On approximately 04-DEC-2017 (reported as "either on 04-DEC-2017 or 05-DEC-2017"), the patient was  vaccinated with GARDASIL 9 injection, intramuscularly for human papilloma virus (HPV) prevention (dose, lot # and expiration date were not reported). It was unknown which dose in the vaccination series of GARDASIL 9 this patient received. On approximately 05-DEC-2017 (reported as "either on 05-DEC-2017 or 06-DEC-2017"), the patient developed a rash that was itchy on an unspecified part of the body. The patient sought medical attention by visiting a pediatrician. The outcome of the event was unknown. The relatedness between the event and GARDASIL 9 was not assessed by the reporter.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 62-year-old female patient. The patient had no pertinent medical history, concomitant medications, drug reactions or allergies. On 06-DEC-2017, the patient was vaccinated with a dose of ZOSTAVAX (dose, frequency and route of administration were not reported) lot # N023002 with expiration date: 20-NOV-2018. On 08-DEC-2017, the patient developed a 3 inch rash with a dark red area and a lighter red area (rash located in an unspecified area of the patient's body). The patient did not received any treatment. The outcome of rash was reported as not recovered at the time of this report. The relatedness between rush and therapy with ZOSTAVAX was not reported.
Age: 51.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Dyspnoea, Headache, Injection site erythema, Injection site pain
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 51-year-old female patient. The patient's medical history included a heart attack in April 2017. The patient's concurrent conditions included diabetes and allergy to PHENERGAN. On 30-NOV-2017, the patient was vaccinated with PNEUMOVAX 23 intramuscularly, in the left deltoid, lot # N012127, expiration date: 20-JAN-2019 (dose was not reported) for prophylaxis. Concomitant therapies included metformin, PLAVIX, BENICAR and atorvastatin. On 01-DEC-2017, the patient developed shortness of breath, fever, weakness, headache/body ache, and soreness/redness at injection site (left deltoid). On the same day, the patient was admitted to the hospital due to the events. The patient had unspecified laboratory tests performed and was given an unspecified treatment for the events. The patient was hospitalized for 3 days (discharged approximately on 04-DEC-2017). The patient came to the office on 11-DEC-2017 for a follow up visit. The outcome of the events was reported as recovering. The causality assessment was not provided.
Age: 51.0
Sex: F
Vaccine: PPV
Symptoms: Laboratory test, Pain, Pyrexia
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 51-year-old female patient. The patient's medical history included a heart attack in April 2017. The patient's concurrent conditions included diabetes and allergy to PHENERGAN. On 30-NOV-2017, the patient was vaccinated with PNEUMOVAX 23 intramuscularly, in the left deltoid, lot # N012127, expiration date: 20-JAN-2019 (dose was not reported) for prophylaxis. Concomitant therapies included metformin, PLAVIX, BENICAR and atorvastatin. On 01-DEC-2017, the patient developed shortness of breath, fever, weakness, headache/body ache, and soreness/redness at injection site (left deltoid). On the same day, the patient was admitted to the hospital due to the events. The patient had unspecified laboratory tests performed and was given an unspecified treatment for the events. The patient was hospitalized for 3 days (discharged approximately on 04-DEC-2017). The patient came to the office on 11-DEC-2017 for a follow up visit. The outcome of the events was reported as recovering. The causality assessment was not provided.
Age: 78.0
Sex: F
Vaccine: PPV
Symptoms: Neoplasm malignant
Clinical narrative: This spontaneous report as received from a nurse practitioner via a company representative refers to a 85-year-old female patient. No information was provided regarding the patient's concomitant medications, pertinent medical history, drug reactions or allergies. On an unknown date, when the patient was 78 years old, she was vaccinated with unspecified pneumococcal vaccine (reported as "product administered might have been PNEUMOVAX 23") (exact dose, dose number, lot #, expiration date and route of administration were not reported) for prophylaxis. On an unknown date at 85 years of age, the patient was diagnosed with cancer. The outcome of the event and the causality assessment between the event and PNEUMOVAX 23 were not provided. Upon internal review, the event of cancer was considered to be medically significant.
Age: 0.08
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a medical assistant referring to a 1 month old patient of unknown gender. Information about concurrent condition, drug reactions/allergies, concomitant therapies and medical history was unknown. On 27-NOV-2017, the patient was vaccinated with AN improperly stored dose of RECOMBIVAX HB (lot # M036156 with expiration date 23-FEB-2019, 1 dose, strength unknown) intramuscularly for prophylaxis (incorrect product storage). No adverse effect was reported. The vaccines were exposure at the temperature of 55.2 Fahrenheit (47 to 77 Fahrenheit) for 2 hours and 41 minutes. There was no previous temperature excursion. A data logger was involved. This is one of 4 reports received from the same reporter.; Sender's Comments: US-009507513-1712USA005650: US-009507513-1712USA005651: US-009507513-1711USA012903:
Age: 1.58
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a medical assistant referring to a 19 months old patient of unknown gender. Information about concurrent condition, drug reactions/allergies, concomitant therapies and medical history was unknown. On 27-NOV-2017, the patient was vaccinated with an improperly stored dose of VAQTA (lot # N017094 with expiration date 31-FEB-2018, 1 dose, strength unknown) intramuscularly for prophylaxis. No adverse effect was reported. The vaccine was exposure at the temperature of 55.2 Fahrenheit (47 to 77 Fahrenheit) for 2 hours and 41 minutes. There was no previous temperature excursion. A data logger was involved. This is one of 4 reports received from the same reporter. Sender's Comments: US-009507513-1711USA012903: US-009507513-1712USA005651: US-009507513-1712USA005649.
Age: 4.0
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a medical assistant referring to a 4 years old patient of unknown gender. Information about concurrent condition, drug reactions/allergies, concomitant therapies and medical history was unknown. On 27-NOV-2017, the patient was vaccinated with a dose of improperly stored VAQTA (lot # N017094 with expiration date 31-FEB-2018, 1 dose, strength unknown) intramuscularly for prophylaxis ((incorrect product storage)). No adverse effect was reported. The vaccine was exposure at the temperature of 55.2 Fahrenheit (47 to 77 Fahrenheit) for 2 hours and 41 minutes. There was no previous temperature excursion. A data logger was involved. This is one of 4 reports received from the same reporter.; Sender's Comments: US-009507513-1711USA012903: US-009507513-1712USA005650: US-009507513-1712USA005649:
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist via a company representative and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 11-DEC-2017, the patient was subcutaneously vaccinated with an expired dose of ZOSTAVAX 19400 PFU vial, 0.65 ml/once, lot # M037654 and expiry date 29-NOV-2017, for prophylaxis reconstituted with properly stored, unexpired sterile diluent, lot M044950 and expiry date 30-MAY-2019. No adverse affects were reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age or gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies. On 12-DEC-2017, the patient was vaccinated with improperly stored dose of PROQUAD therapy type of recombinant human albumin (rHA) (exact dose, dose number, route of administration were not reported; lot # N020010 with the expiration date of 13-JAN-2019) for prophylaxis. The administered vaccine was reconstituted with properly stored sterile diluent (lot# and expiration date were not reported). The administered dose of PROQUAD underwent a temperature excursion between minus 14 and minus 10 Celsius degrees for 1 hour, and between minus 9 to 8 (also reported as minus 6) Celsius degrees for 1 hour and 30 minutes. Digital data logger was involved to capture the temperature excursions. There were no previous temperature excursions reported. No adverse effects were reported.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 12-DEC-2017, the patient was vaccinated with a first dose of expired VARIVAX lot # L049532, expiry date 08-DEC-2017 for prophylaxis. No adverse event was reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX, lot # N010108, expiration date: 20-MAR-2019, for prophylaxis (dose #, route and anatomical location of administration were unknown). The dose was stored from -14 Celsius degrees (C) to -10 C (-14.1 C) for 76 minutes, from -9 C to 8 C (-8.7 C) for 103 minutes, and from -14 C to -10 C (-11.2 C) for 11 hours. The temperature excursion was detected by a data logger. The sterile diluent (manufacturer unknown) used for reconstitution was properly stored. No adverse effects were reported. This is one of several reports received from the same rerporter.; Sender's Comments: US-009507513-1711USA011997: US-009507513-1712USA006542: US-009507513-1712USA006543: US-009507513-1712USA006544: US-009507513-1712USA006545:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX, lot # N010108, expiration date: 20-MAR-2019, for prophylaxis (dose #, route and anatomical location of administration were unknown). The dose was stored from -14 Celsius degrees (C) to -10 C (-14.1 C) for 76 minutes, from -9 C to 8 C (-8.7 C) for 103 minutes, and from -14 C to -10 C (-11.2 C) for 11 hours. The temperature excursion was detected by a data logger. The sterile diluent (manufacturer unknown) used for reconstitution was properly stored. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1711USA011997: US-009507513-1712USA006541: US-009507513-1712USA006543: US-009507513-1712USA006544: US-009507513-1712USA006545.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX, lot # N010108, expiration date: 20-MAR-2019, for prophylaxis (dose #, route and anatomical location of administration were unknown). The dose was stored from -14 Celsius degrees (C) to -10 C (-14.1 C) for 76 minutes, from -9 C to 8 C (-8.7 C) for 103 minutes, and from -14 C to -10 C (-11.2 C) for 11 hours. The temperature excursion was detected by a data logger. The sterile diluent (manufacturer unknown) used for reconstitution was properly stored. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1711USA011997: US-009507513-1712USA006541: US-009507513-1712USA006542: US-009507513-1712USA006544: US-009507513-1712USA006545.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX, lot # N010108, expiration date: 20-MAR-2019, for prophylaxis (dose #, route and anatomical location of administration were unknown). The dose was stored from -14 Celsius degrees (C) to -10 C (-14.1 C) for 76 minutes, from -9 C to 8 C (-8.7 C) for 103 minutes, and from -14 C to -10 C (-11.2 C) for 11 hours. The temperature excursion was detected by a data logger. The sterile diluent (manufacturer unknown) used for reconstitution was properly stored. No adverse effects were reported. This is one of several reports received from the same source. Sender's Comments: US-009507513-1711USA011997: US-009507513-1712USA006541: US-009507513-1712USA006542: US-009507513-1712USA006543: US-009507513-1712USA006545.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX, lot # N010108, expiration date: 20-MAR-2019, for prophylaxis (dose #, route and anatomical location of administration were unknown). The dose was stored from -14 Celsius degrees (C) to -10 C (-14.1 C) for 76 minutes, from -9 C to 8 C (-8.7 C) for 103 minutes, and from -14 C to -10 C (-11.2 C) for 11 hours. The temperature excursion was detected by a data logger. The sterile diluent (manufacturer unknown) used for reconstitution was properly stored. No adverse effects were reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1711USA011997: US-009507513-1712USA006541: US-009507513-1712USA006542: US-009507513-1712USA006543: US-009507513-1712USA006544:
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain in extremity, Paraesthesia
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's concurrent conditions, medical history and concomitant medication use were not provided. On an unspecified date, in approximately 2012, the patient was vaccinated with  ZOSTATAVAX (lot# and route unknown) for routine health maintenance and for the prevention of shingles. The vaccine did not prevent shingles, but rather caused the patient to contract a persistent strain of herpes zoster. Shortly after receiving ZOSTAVAX vaccine, the patient developed and was diagnosed with bilateral leg pain and paresthesia of the skin. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment.  As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blindness, Eye pruritus, Herpes zoster, Ocular hyperaemia, Visual impairment
Clinical narrative: Information was received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. On or about 14-JAN-2015, the patient was inoculated  with ZOSTAVAX (lot number, dosage, and route of administration not provided), as recommended at physician's office for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. Shortly after receiving the ZOSTAVAX vaccine, the patient developed itching and redness in her left eye. Thereafter, the patient was diagnosed with vision complications, including severe vision loss, in both eyes. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Upon internal review, severe vision loss in both eyes was determined to be medically significant. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Bone pain, Facial pain, Herpes zoster, Injury, Toothache
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. Information regarding medical history, concurrent conditions or concomitant medications was not provided. On or about 05-JAN-2017, the patient was inoculated with ZOSTAVAX at a pharmacy for routine health maintenance and for the prevention of shingles.  The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. Shortly after receiving ZOSTAVAX, the patient developed severe tooth pain which radiated into his left cheekbone and eventually throughout the left side of his face.  On or about 18-FEB-2017, he presented to a hospital where he was ultimately diagnosed with trigeminal neuralgia.  As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. As a result of ZOSTAVAX, the patient suffered severe and permanent personal injuries. Further, he suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, and physical impairment and injury. The lawyer considered trigeminal neuralgia, vaccination failure and herpes zoster to be disabling. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Trigeminal neuralgia
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. Information regarding medical history, concurrent conditions or concomitant medications was not provided. On or about 05-JAN-2017, the patient was inoculated with ZOSTAVAX at a pharmacy for routine health maintenance and for the prevention of shingles.  The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. Shortly after receiving ZOSTAVAX, the patient developed severe tooth pain which radiated into his left cheekbone and eventually throughout the left side of his face.  On or about 18-FEB-2017, he presented to a hospital where he was ultimately diagnosed with trigeminal neuralgia.  As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. As a result of ZOSTAVAX, the patient suffered severe and permanent personal injuries. Further, he suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, and physical impairment and injury. The lawyer considered trigeminal neuralgia, vaccination failure and herpes zoster to be disabling. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's concurrent conditions, concomitant medications, pertinent medical history and drug reactions or allergies were not provided. On 01-DEC-2017, the patient was administered an improperly stored dose of GARDASIL 9 injection, lot # N015089 with expiration date on 20-OCT-2019 (dose and route of administration were not reported). The administered dose of vaccine underwent a temperature excursion of 47.6 degrees Fahrenheit, which lasted for an unspecified time. There was no previous temperature excursion. A digital data logger was not involved in recording the excursion. No adverse effects were reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1712USA008158: US-009507513-1712USA008159: US-009507513-1712USA008160: US-009507513-1712USA008161: US-009507513-1712USA008162: US-009507513-1712USA002258:
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's concurrent conditions, concomitant medications, pertinent medical history and drug reactions or allergies were not provided. On 01-DEC-2017, the patient was administered an improperly stored dose of VAQTA, lot# N019924 with expiration date on 02-SEP-2018 (dose and route of administration were not reported). The administered dose of vaccine underwent a temperature excursion of 47.6 degrees Fahrenheit, which lasted for an unspecified time. There was no previous temperature excursion. A digital data logger was not involved in recording the excursion. No adverse effects were reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1712USA002258: US-009507513-1712USA008157: US-009507513-1712USA008159: US-009507513-1712USA008160: US-009507513-1712USA008161: US-009507513-1712USA008162:
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's concurrent conditions, concomitant medications, pertinent medical history and drug reactions or allergies were not provided. On 01-DEC-2017, the patient was administered an improperly stored dose of VAQTA, lot# N019924 with expiration date on 02-SEP-2018 (dose and route of administration were not reported). The administered dose of vaccine underwent a temperature excursion of 47.6 degrees Fahrenheit, which lasted for an unspecified time. There was no previous temperature excursion. A digital data logger was not involved in recording the excursion. No adverse effects were reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1712USA008157: US-009507513-1712USA008158: US-009507513-1712USA008160: US-009507513-1712USA008161: US-009507513-1712USA008162: US-009507513-1712USA002258:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's concurrent conditions, concomitant medications, pertinent medical history and drug reactions or allergies were not provided. On 01-DEC-2017, the patient was administered an improperly stored dose of ROTATEQ, lot # N015129 with expiration date on 11-DEC-2018 (dose was not reported). The administered dose of vaccine underwent a temperature excursion of 47.6 degrees Fahrenheit, which lasted for an unspecified time. There was no previous temperature excursion. A digital data logger was not involved in recording the excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1712USA002258: US-009507513-1712USA008157: US-009507513-1712USA008158: US-009507513-1712USA008159: US-009507513-1712USA008161: US-009507513-1712USA008162.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's concurrent conditions, concomitant medications, pertinent medical history and drug reactions or allergies were not provided. On 01-DEC-2017, the patient was administered an improperly stored dose of ROTATEQ, lot # N015129 with expiration date on 11-DEC-2018 (dose was not reported). The administered dose of vaccine underwent a temperature excursion of 47.6 degrees Fahrenheit, which lasted for an unspecified time. There was no previous temperature excursion. A digital data logger was not involved in recording the excursion. No adverse effects were reported. This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1712USA002258: US-009507513-1712USA008157:US-009507513-1712USA008158: US-009507513-1712USA008159: US-009507513-1712USA008160: US-009507513-1712USA008162:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's concurrent conditions, concomitant medications, pertinent medical history and drug reactions or allergies were not provided. On 01-DEC-2017, the patient was administered an improperly stored dose of ROTATEQ, lot # N015129 with expiration date on 11-DEC-2018 (dose was not reported). The administered dose of vaccine underwent a temperature excursion of 47.6 degrees Fahrenheit, which lasted for an unspecified time. There was no previous temperature excursion. A digital data logger was not involved in recording the excursion. No adverse effects were reported. This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1712USA008157: US-009507513-1712USA008158: US-009507513-1712USA008159: US-009507513-1712USA008160: US-009507513-1712USA008161: US-009507513-1712USA002258:
Sex: U
Vaccine: PNC13
Symptoms: Infection, Peripheral swelling
Clinical narrative: This is a spontaneous report obtained from a non-contactable Health Care Professional through a Pfizer sales representative. A patient of an unspecified age, gender, race and ethnicity received PREVNAR 13 on an unknown date, at single dose, for immunization. Relevant medical history was unknown. On an unspecified date, the patient experienced swelling and infection in arm after co-administration with flu vaccine. Clinical outcome of the events was unknown at time of this report. No follow-up attempts are possible, information about lot number cannot be obtained. No further information expected.