chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a licensed practical nurse referring to a unspecified patients of unknown ages and genders. Information regarding medical history, drug reactions, allergies, concomitant therapies and concurrent conditions was not provided. Since 03-JAN-2017, the unspecified patients were vaccinated with improperly stored doses ROTATEQ lot# M031650 and expiration date 16-MAR-2018, orally (strength, dose and frequency were unknown by the reporter), for prophylaxis. The reporter stated that the temperature excursion of the vaccine was 0 Celsius (C) to 2 Celsius (C) and the time frame was 10 hours, also she stated that the previous temperature excursion was not involved, this information was registered in a digital data logger. No adverse effect was reported. This is one of several cases received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1702USA011537: US-009507513-1702USA010881.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a registered nurse referring to an unspecified number of patients of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of ROTATEQ orally (strength,  dose, frequency, lot# and expiration date were unspecified by the reporter) for prophylaxis. The reporter stated that the administered vaccines experienced two temperature excursions: the first one between 32F and 36F for 57 hours, and the other one between 46F and 77F for 24 hours. No previous temperature excursions were reported and the reported information was not registered in a digital data logger. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1703USA000341: US-009507513-1702USA005592:
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a registered nurse referring to an unspecified number of patients of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of PEDVAXHIB (strength, route of administration, dose, frequency, lot# and expiration date were unspecified by the reporter) for prophylaxis. The reporter stated that the administered vaccines experienced two temperature excursions: the first one between 32F and 36F for 57 hours, and the other one between 46F and 77F for 24 hours. No previous temperature excursions were reported and the reported information was not registered in a digital data logger. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1702USA005592: US-009507513-1703USA000340.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a registered nurse, referring to an unspecified number of patients of unknown age and gender. Information regarding medical history, drug reactions, allergies, concurrent conditions and concomitant therapies were not reported. From 30-DEC-2016 to 02-FEB-2017, the patients were vaccinated with improperly stored doses of VARIVAX lot # M033213, expiration date 13-JUL-2018 (strength, route of administration, dose, and frequency were not provided) for prophylaxis. The reporter stated that the temperature range of the vaccine was more than -10 Celsius degrees but less than 8 Celsius degrees and the timeframe was 768 hours. Also, they stated that previous temperature excursion was not involved, and this information was no registered in a digital data logger. No adverse effect was reported. This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1702USA002851:
Age: 3.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site erythema, Injection site mass, Injection site swelling, Injection site warmth
Clinical narrative: Large lump at injection site, redness and swelling, warmth to touch.
Age: 37.0
Sex: F
Vaccine: RAB
Symptoms: Headache, Paraesthesia, Vomiting
Clinical narrative: Complained of headache and vomiting x 6.Also complained of tingling of hands and feet.
Age: 0.67
Sex: U
Vaccine: RV5
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to a 34 week old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with a fourth dose of ROTATEQ orally, for prophylaxis (strength, dose, anatomical location, lot number and expiration date were not provided). No adverse events and no product quality complaint (PCQ) were involved.    Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to unspecified number of patients of unknown age and gender. The patients' pertinent medical history, concomitant medications, drug reactions or allergies were not reported. On unspecified dates, improperly stored doses of VARIVAX (dose, route and site of administration, lot # and expiration date were not reported) were administered to the patients. The vaccine was stored in the temperature between 5 and 14 degrees Fahrenheit for 60 minutes. There was no previous temperature excursion. Digital data logger was involved. No adverse effects were reported. No product quality complain was involved. This is one of several reports received from the same source. Additional information is not expected as no consent for contact with the reporter was given. Sender's Comments: US-009507513-1702USA006714: US-009507513-1702USA006713: US-009507513-1702USA006711: US-009507513-1702USA006712.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to unspecified number of patients of unknown age and gender. The patients' pertinent medical history, concomitant medications, drug reactions or allergies were not reported. On unspecified dates, improperly stored doses of GARDASIL 9 (dose, route and site of administration, lot # and expiration date were not reported) were administered to the patients. The vaccine was stored in the temperature between 46 and 77 degrees Fahrenheit for 15 minutes and between 32 and 36 degrees Fahrenheit for 18 minutes. There was no previous temperature excursion. Digital data logger was involved. No adverse effects were reported. No product quality complain was involved. This is one of several reports received from the same source. Additional information is not expected as no consent for contact with the reporter was given. Sender's Comments: US-009507513-1702USA006676: US-009507513-1702USA006711: US-009507513-1702USA006713: US-009507513-1702USA006714.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to unspecified number of patients of unknown age and gender. The patients' pertinent medical history, concomitant medications, drug reactions or allergies were not reported. On unspecified dates, improperly stored doses of ROTATEQ orally (dose, lot # and expiration date were not reported) were administered to the patients. The vaccine was stored in the temperature between 46 and 77 degrees Fahrenheit for 15 minutes and between 32 and 36 degrees Fahrenheit for 18 minutes. There was no previous temperature excursion. Digital data logger was involved. No adverse effects were reported. No product quality complain was involved. This is one of several reports received from the same source. Additional information is not expected as no consent for contact with the reporter was given. Sender's Comments: US-009507513-1702USA006676: US-009507513-1702USA006711: US-009507513-1702USA006712: US-009507513-1702USA006714.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to unspecified number of patients of unknown age and gender. The patients' pertinent medical history, concomitant medications, drug reactions or allergies were not reported. On unspecified dates, improperly stored doses of PNEUMOVAX23 (dose, route and site of administration, lot # and expiration date were not reported) were administered to the patients. The vaccine was stored in the temperature between 46 and 77 degrees Fahrenheit for 15 minutes and between 32 and 36 degrees Fahrenheit for 18 minutes. There was no previous temperature excursion. Digital data logger was involved. No adverse effects were reported. No product quality complain was involved. This is one of several reports received from the same source.  Additional information is not expected as no consent for contact with the reporter was given.; Sender's Comments: US-009507513-1702USA006676: US-009507513-1702USA006711: US-009507513-1702USA006712: US-009507513-1702USA006713:
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to 3 patients of unknown age and gender. The patients' pertinent medical history, concomitant medications, drug reactions or allergies were not reported. On 16-FEB-2017, improperly stored doses of PROQUAD (lot # M036294, expiry date 13-FEB-2019, dose, route and site of administration were not reported) were administered to the patients. The vaccines were stored in the temperature between - 10 and 8 degree Celsius for 14 hours. There was no previous temperature excursion. Digital data logger was involved. No adverse effects were reported. No product quality complain was involved. Additional information has been requested.
Age: 69.0
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist, concerning a 69 years old patient of an unknown gender. There were no concurrent conditions, medical history, drug reactions or allergies or concomitant medications reported. On 21-FEB-2017, the patient was vaccinated with an incorrect storage dose of ZOSTAVAX (dose, frequency and route were not reported), lot # M033909 with expiration date of 17-OCT-2017, for prophylaxis. No adverse effects were reported. The temperature excursion of the ZOSTAVAX was greater than -10 °C but less than 8 °C (>14 °F but <46 °F), for a time frame of 17 hours. No previous temperature incursion was reported. No product quality complaint was involved (PQC). Data logger was involved. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant, concerning a patient of an unknown age and gender. There were no concurrent conditions, medical history, drug reactions or allergies or concomitant medications reported. On an unspecified date, the patient may have been vaccinated with an improperly stored dose of VAQTA 25/0.5 (units not provided) (dose, frequency and route were not reported) lot # M027879 with expiration date of 24-JAN-2018, for prophylaxis. No adverse effects were reported. The temperature excursion of the VAQTA was between 32 F and 36 F, for a time frame of 72 hours. No previous temperature incursion was reported and no data logger was involved. No product quality complaint was involved (PQC). This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1703USA000334: US-009507513-1703USA000331.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative
Clinical narrative: This spontaneous report was received from a physician via company representative and refers to multiple unspecified patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. On unknown dates in past, the patients were vaccinated with RECOMBIVAX HB (dosing details were not reported) for prophylaxis. Physician reported that all the patients had negative antibodies (Hepatitis B surface antibody negative) and were needed to be revaccinated. Outcome of the event was unknown. Causality assessment was not provided. Additional information is not expected, no contact details were provided.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse practitioner referring to multiple unknown patients of unknown age and gender. The patients' concurrent conditions, concomitant medication and medical history were not provided. On unspecified dates, the patients were vaccinated with improperly stored PEDVAXHIB (lot # M032148, expiration date: 18-APR-2019; lot# M036057, expiration date: 18-MAY-2019; dose and route unknown) for prophylaxis. The PEDVAXHIB was stored under temperature between 32 Fahrenheit and 36 Fahrenheit for 44 hours. There was no previous temperature excursion. Data logger was involved. No adverse effects reported. No product quality complaint was involved. This is one of two reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1703USA002539.
Sex: U
Vaccine: MMR
Symptoms: Mumps
Clinical narrative: Information was received from a pharmacist via a company representative. The pharmacist reported that there are "12 confirmed cases of mumps" and "19 cases pending" on unspecified dates (patient demographics not provided). The pharmacist reported that "some of the 12 cases" have had two doses of M-M-R II (dates of vaccination, lot numbers, dosages and routes of administration not provided). The outcome of mumps is unknown. There was limited knowledge of the "mumps outbreak," therefore no further information was obtained. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information was received from a pharmacist concerning a patient of unknown age and gender. The pharmacist reported that an expired dose of ZOSTAVAX (lot # L040443, expiration date 15-JAN-2017) was administered to an unspecified patient on 02-MAR-2017 (dosage and route of administration not provided). No adverse effects. No further information to report. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Pain
Clinical narrative: This spontaneous report received from a nurse referred to an unknown number of patients of unknown age and gender. Medical histories, past drug histories, and concomitant medications are unknown. The nurse reported that she briefly googled on 03-MAR-2017 and it was reported that an unknown number of patients of unknown ages and genders started PNEUMOVAX23 (dose, frequency, lot and expiry date not reported). She saw online that an unknown number of patients experienced horrible pain after receiving the PNEUMOVAX23. Outcome and causality of the event was not reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse practitioner referring to multiple unknown patients of unknown age and gender. The patients' concurrent conditions, concomitant medication and medical history were not provided. On unspecified dates, the patients were vaccinated with improperly stored GARDASIL 9 (lot # M031557, expiration date: 07-APR-2019; lot# M034780, expiration date: 15-APR-2019; dose and route unknown) for prophylaxis. The GARDASIL 9 was stored under temperature between 32 Fahrenheit and 36 Fahrenheit for 44 hours. There was no previous temperature excursion. Data logger was involved. No adverse effects reported. No product quality complaint was involved. This is one of two reports received from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1702USA012115:
Age: 14.0
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse concerning a 14 years old patient of unknown gender. Information about concurrent condition, concomitant medication and medical history was not provided. On 20-DEC-2016, the patient was vaccinated with a dose of improperly stored GARDASIL 9 (lot # L024993, expiration date 17-OCT-2017, dose and route unspecified) for prophylaxis. The vaccines were stored at 11.6 degree centigrade for 1 hour and 50 minutes. Data logger was involved in the case. There was previous temperature excursion at 9.3 degree centigrade for 50 minutes. No adverse effect was reported. It was reported that the excursion involved a total of three lots of GARDASIL 9. Two lots (L024993 and M024261) were involved in the event "doses of GARDASIL 9 administered after 13-DEC-2016 temperature incident". This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1612USA008047: US-009507513-1612USA007442: US-009507513-1703USA002792: US-009507513-1703USA002793: US-009507513-1703USA002794: US-009507513-1703USA002796: US-009507513-1703USA002797: US-009507513-1703USA002798:  US-009507513-1703USA002799: US-009507513-1702USA010448:
Age: 17.0
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse concerning a 17 years old patient of unknown gender. Information about concurrent condition, concomitant medication and medical history was not provided. On 18-JAN-2017, the patient was vaccinated with a dose of improperly stored GARDASIL 9 (lot # M024261, expiration date, dose and route unknown) for prophylaxis. The vaccines were stored at 11.6 degree centigrade for 1 hour and 50 minutes. Data logger was involved in the case. There was previous temperature excursion at 9.3 degree centigrade for 50 minutes. No adverse effect was reported. It was reported that the excursion involved a total of three lots of GARDASIL 9. Two lots (L024993 and M024261) were involved in the event "doses of GARDASIL 9 administered after 13-DEC-2016 temperature incident". This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1612USA008047: US-009507513-1612USA007442: US-009507513-1703USA002792: US-009507513-1703USA002793: US-009507513-1703USA002794: US-009507513-1703USA002795: US-009507513-1703USA002797: US-009507513-1703USA002798: US-009507513-1703USA002799: US-009507513-1702USA010448:
Age: 11.0
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse concerning a 11 years old patient of unknown gender. Information about concurrent condition, concomitant medication and medical history was not provided. On 18-JAN-2017, the patient was vaccinated with a dose of improperly stored GARDASIL 9 (lot # M024261, expiration date, dose and route unknown) for prophylaxis. The vaccines were stored at 11.6 degree Centigrade for 1 hour and 50 minutes. Data logger was involved in the case. There was previous temperature excursion at 9.3 degree Centigrade for 50 minutes. No adverse effect was reported. It was reported that the excursion involved a total of three lots of GARDASIL 9. Two lots (L024993 and M024261) were involved in the event "doses of GARDASIL 9 administered after 13-DEC-2016 temperature incident". This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA008047: US-009507513-1612USA007442: US-009507513-1703USA002792: US-009507513-1703USA002793: US-009507513-1703USA002794: US-009507513-1703USA002795: US-009507513-1703USA002796: US-009507513-1703USA002798: US-009507513-1703USA002799: US-009507513-1702USA010448.
Age: 11.0
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse concerning a 11 years old patient of unknown gender. Information about concurrent condition, concomitant medication and medical history was not provided. On 17-JAN-2017, the patient was vaccinated with a dose of improperly stored GARDASIL 9 (lot # M024261, expiration date, dose and route unknown) for prophylaxis. The vaccines were stored at 11.6 degree centigrade for 1 hour and 50 minutes. Data logger was involved in the case. There was previous temperature excursion at 9.3 degree centigrade for 50 minutes. No adverse effect was reported. It was reported that the excursion involved a total of three lots of GARDASIL 9. Two lots (L024993 and M024261) were involved in the event "doses of GARDASIL 9 administered after 13-DEC-2016 temperature incident". This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1612USA008047: US-009507513-1612USA007442: US-009507513-1703USA002792: US-009507513-1703USA002793: US-009507513-1703USA002794: US-009507513-1703USA002795: US-009507513-1703USA002796: US-009507513-1703USA002797: US-009507513-1703USA002799: US-009507513-1702USA010448:
Age: 11.0
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse concerning a 11 years old patient of unknown gender. Information about concurrent condition, concomitant medication and medical history was not provided. On 19-DEC-2016, the patient was vaccinated with a dose of improperly stored GARDASIL 9 (lot # M024261, expiration date, dose and route unknown) for prophylaxis. The vaccines were stored at 11.6 degree Centigrade for 1 hour and 50 minutes. Data logger was involved in the case. There was previous temperature excursion at 9.3 degree Centigrade for 50 minutes. No adverse effect was reported. It was reported that the excursion involved a total of three lots of GARDASIL 9. Two lots (L024993 and M024261) were involved in the event "doses of GARDASIL 9 administered after 13-DEC-2016 temperature incident". This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA008047: US-009507513-1612USA007442: US-009507513-1703USA002792: US-009507513-1703USA002793: US-009507513-1703USA002794: US-009507513-1703USA002795: US-009507513-1703USA002796: US-009507513-1703USA002797: US-009507513-1703USA002798: US-009507513-1702USA010448.
Sex: U
Vaccine: FLU3
Symptoms: Injection site pain, Joint range of motion decreased, Rotator cuff syndrome
Clinical narrative: This spontaneous case, initially received on 21-Nov-2016, was reported by a health professional and concerns a(n) adult unk patient. Weight: not provided; Height: not provided Concomitant medication: Not reported Administration of company suspect drug(s): The patient received AFLURIA from Oct-2016 to Oct-2016 Dose regimen:0.5 ml, Site: Deltoid area, Route of administration: Intramuscular. Batch number: WT54707. No additional suspect drugs. Adverse reactions/events and outcomes: On an unknown date, the patient experienced Range of motion problems (outcome: Not recovered / Not resolved), Significant  pain that lasted 2 weeks or longer at the injection site (outcome: Not recovered / Not resolved). ***Follow-up information received 13-Dec-2016: The patient was recommended to rest arm and use ice or heat if needed for pain and was referred to an orthopaedist for rotator cuff issue (outcome: not recovered / not resolved). The patient experienced no other associated symptoms. The outcome was reported as continuing with orthopaedist. All doses were administered by a RN (registered nurse) or a Certified Medical Assistant who is also a paramedic. Both have been administering flu vaccines for years. A 22 gauge 1 inch or 1.5 inch needle was used. The RN is certain that the dose was administered correctly in the deltoid muscle of the arm as trained. ****Case correction (23-Feb-2017): QA investigation results added and the event 'rotator cuff issue' upgraded to serious. QA investigation results: Final assessment: Risk has been excluded. The review and investigation of the manufacturing, dispensing, shipping and product testing of Influenza Vaccine lot: WT54707 found no evidence of a product quality issue to prompt the potential 'vaccine reaction'. The patient did not receive any other concomitant vaccination on the same arm.; Sender's Comments: Listedness: Assessment according to CCSI for CSL's Inactivated Influenza Virus Vaccine, Hereditary rotator cuff syndrome, and Joint range of motion decreased are unlisted. Injection site pain is listed. Causality: Related. Time to event onset not clearly stated but close temporal relationship implied as pain lasted 2 weeks after vaccination. The event severity, associated with impaired range of motion and duration of symptoms lasting weeks following vaccination, is suggestive of Shoulder injury related to vaccine administration (SIRVA). SIRVA is sequelae of immune response to direct (inadvertent) intra-articular vaccine antigens. However there were no examination findings and or investigation results to confirm SIRVA and or exclude other cause of symptoms. Causality is considered related to vaccination due to temporal association most likely due to incorrect technique.
Age: 35.0
Sex: F
Vaccine: MMR
Symptoms: Erythema, Induration, Mass, Skin warm, Tenderness
Clinical narrative: Slightly red/warm to the touch.  I have a pretty large and hard lump in side that is slightly painful when I touch it, and after massaging it. It has gotten bigger in the last week.
Age: 23.0
Sex: M
Vaccine: ANTH
Symptoms: Asthenia, Electrocardiogram, Fatigue, Heart rate increased
Clinical narrative: I had a extremely rapid heart beat a few days after taking the vaccine. Walking, standing up made me feel weak and extremely tired. I got an EKG. Laying completely still wasn't an issue.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Red, swelling at site of injection, about half dollar size.
Age: 23.0
Sex: F
Vaccine: MEA, MU, RUB
Symptoms: Headache
Clinical narrative: Headache lasting for 5-6 hours.
Age: 9.0
Sex: M
Vaccine: FLU4, MMR
Symptoms: Urticaria
Clinical narrative: Pt developed 3 hives on skin - face, back, leg. No other signs/symptoms. Attempted to give Benadryl but parents never picked-up medication.
Age: 4.0
Sex: F
Vaccine: UNK
Symptoms: Autoimmune disorder, Chemotherapy, Epstein-Barr virus infection, Herpes zoster, Hodgkin's disease
Clinical narrative: Epstein Barr virus resulting in ER visit. 1978 diagnosed with Hodgkins Lymphoma. 1979 Remission after MOPP. 1980 shingles. 3 hospitalizations for bacterial pneumonia. 2 episodes of mono. impaired immune functioning with autoimmune disorder. Early onset menopause, completed by age 39.
Age: 4.0
Sex: F
Vaccine: UNK
Symptoms: Immune system disorder, Infectious mononucleosis, Pneumonia bacterial, Premature menopause
Clinical narrative: Epstein Barr virus resulting in ER visit. 1978 diagnosed with Hodgkins Lymphoma. 1979 Remission after MOPP. 1980 shingles. 3 hospitalizations for bacterial pneumonia. 2 episodes of mono. impaired immune functioning with autoimmune disorder. Early onset menopause, completed by age 39.
Age: 3.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.   The nurse reported that, on 04-AUG-2016, the patient received an improperly stored VARIVAX (Lot #: L042265; Expiration date: 26-OCT-2017) for prophylaxis (Dose, route and anatomical location were not reported). No adverse effects reported. Temperature/Time frame: >-15°C but <-10°C (>5°F but < 14°F) excursion reported for 46 hours 10 minutes (worst case) Previous temperature excursion:   >-15°C but <-10°C (>5°F but < 14°F) excursion reported for 133 hours and 30 minutes (worst case) The call was not because of a "data logger". There was no Product Quality Complaint (PQC) involved. This is one of several reports from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1701USA005376:
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant, concerning a patient of an unknown gender and age. There were no concurrent conditions, medical history, drug reactions or allergies or concomitant medications reported. On 22-FEB-2017, the patient was vaccinated with an expired dose of M-M-R II (dose, frequency and route not reported) lot # reported as M001200 with expiration date of 28-AUG-2016. No adverse effects were reported. No product quality complaint was involved (PQC). Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a physician 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 an unknown date in 2012, the patient was with a first dose of GARDASIL (dose, route of administration, anatomical location, lot # and expiration date were not reported).   On 22-FEB-2017, the patient received his second dose of GARDASIL lot # M028323 with an expiration date 26-AUG-2018 (dose, route of administration and anatomical location were not reported) which was outside of the recommendations for GARDASIL prescribing information. No adverse effects were reported. Product quality complaint (PQC) was not reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist, refers to multiple, unspecified patients of unknown age and gender. The Pharmacist reported that multiple unspecified patients were administered improperly stored PROQUAD (dose and route of administration were not reported). It was a case of a digital data logger. Following batches were involved: Lot# M002055, expiration date 11-JUL-2017, time frame for temperature excursions were as follows: -2 degrees Celsius for 1 hour 36 minutes, 2.9 degrees Celsius for 3 hours 42 minutes, -8.1 degrees Celsius for 1 hour 36 minutes. It was reported that there were previous temperature excursions, as follows: -11.5 degrees Celsius for 30 minutes,  -7.4 degrees Celsius for 2 hours 12 minutes, -7.5 degrees Celsius for 48 minutes. Albumin status for Lot# M002055 has been verified as recombinant human albumin (rHA). Lot # M007965, expiration date 15-AUG-2017, time frame for temperature excursions: -2 degrees Celsius for 1 hour 36 minutes, 2.9 degrees Celsius for 3 hours 42 minutes. It was reported that there were previous temperature excursions, as follows: -8.1 degrees Celsius for 1 hour 36 minutes,  -7.5 degrees Celsius for 48 minutes, -13.4 degrees Celsius for 18 minutes, -13.7 degrees Celsius 12 for minutes. Albumin status for Lot# M007965 has been verified as recombinant human albumin (rHA). Follow-up information has been received on 28-NOV-2016 from the pharmacist via phone call, providing new stability data and an additional lot number to add to the case. Names of vaccines involved: PROQUAD, (lot# M007961, expiration date 15-MAY-2017, therapy type: rHA), subjected to following temperature excursions: 2.9 Celsius, time frame: 1 hour. Reported cumulative time frame was 11 hours 24 minutes. The time frames and temperatures were double checked with the pharmacist. Albumin status for Lot# M007961 has been verified as recombinant human albumin (rHA). No adverse effects were reported by patients. No further information provided. Follow up information was received on 17-FEB-2017. All telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested.; Sender's Comments: US-009507513-1611USA013319:
Sex: M
Vaccine: HEPA
Symptoms: No adverse event, Product quality issue, Syringe issue
Clinical narrative: Information was received from a nurse practitioner via a company representative concerning a male patient of unknown age.  The nurse practitioner reported that while administering an intramuscular dose of pediatric VAQTA 25U/0.5 mL, lot number not provided, expiration date 02-FEB-2018, (frequency reported as "1/and booster 6 to 18 months") 0.5 mL from a prefilled syringe to the patient, the syringe was leaking. She stated that she administered another prefilled dose of pediatric VAQTA 0.5 mL to ensure the full dose was received. No adverse effects were reported.  No further information was provided. Product quality complaint was filed. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist concerning a 63 years old female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 07-DEC-2016 at 10:43, the patient was vaccinated with a dose of ZOSTAVAX, subcutaneously in the left arm, lot # M033335, expiration date 11-OCT-2017, for prophylaxis (dose number were unknown), which was improperly stored at 8.96 degrees Fahrenheit for 2 hours. There was no previous temperature excursion. Data logger was involved. No adverse effects were reported. The pharmacist stated that their freezer temporarily read the temperature out of range because 2 non-frozen cold packs were placed both above and below sensor, once removed the temperature stabilized and returned to normal. This is one of several reports received from the same reporter. Additional information is not expected as all follow up information has been received.; Sender's Comments:  US-009507513-1612USA004193:
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Headache, Wheelchair user
Clinical narrative: This is a spontaneous report from a contactable physician via a Pfizer sales representative. A 18-year-old female patient of an unspecified race and ethnicity received the first single dose of TRUMENBA via an unspecified route of administration on 28Feb2017 for immunization. The patient medical history and concomitant medications were not reported. The patient experienced severe headache on 28Feb2017 within 20 minutes from the vaccination. Her vital parameters were stable but pain was 100 on a scale of 1-10 and she needed wheel chair assistance. Headache resolved within ibuprofen and paracetamol (TYLENOL) after 20 minutes, outcome of pain was unknown. The patient did not want to receive the second dose to complete the series.
Sex: F
Vaccine: MENB
Symptoms: Chills, Lethargy, Nausea, Pain in extremity
Clinical narrative: This is a spontaneous report obtained from a contactable nurse through a Pfizer sales representative. This nurse reported for two patients. This is the 1st of two reports. An 18-year-old female patient of an unspecified race/ethnicity received TRUMENBA (Lot # R94916, Expiry date  01Jan2019) intramuscular at 0.5 ml, single in the arm on 22Feb2017 for immunisation. The patient medical history and concomitant medications were not reported.  On an unspecified date in Feb2017, the patient experienced nausea, chills, lethargic, arm soreness of the arm that the product was injected into. The patient did not experience any fever. The outcome of the events was recovered on unknown date.
Sex: M
Vaccine: MENB, MNQ
Symptoms: Fatigue, Lethargy, Muscular weakness, Pain in extremity
Clinical narrative: This is a spontaneous report obtained from a contactable nurse through a Pfizer sales representative. This nurse reported for two patients. This is the second of two reports. A 17-year-old male patient of an unspecified race and ethnicity received, on 28Feb2017, TRUMENBA        (Lot. R94916, Expiration date: 01Jan2019) intramuscularly, into the arm, at 0.5 ml, single dose and MENACTRA intramuscularly, into the arm, at 0.5 ml, single dose, both  for immunization. Relevant medical history and concomitant medications were unknown. On an unspecified date, in 2017, the patient's  arms were sore and he had weakness of both arms. The patient also was lethargic and he was very tired to the point that he missed a dentist appointment. The patient did not experience any fever. Clinical outcome was unknown at time of this report.
Sex: F
Vaccine: MENB
Symptoms: Chills, Influenza like illness, Injection site pain, Pain, Pyrexia
Clinical narrative: This is a spontaneous report from a non-contactable consumer reporting for the daughter. This female patient of an unspecified age, race and ethnicity received a single dose of TRUMENBA via an unspecified route of administration on 02Mar2017 for immunization.  The patient medical history and concomitant medications were not reported.  Since the day of vaccination the patient experienced body ache (whole body hurt) and low grade fever (body temperature was at 100 F), injection site really hurt a lot, she had flu like symptoms and chills. Outcome of events was unknown. No follow-up attempts are possible. No further information is expected.
Age: 19.0
Sex: M
Vaccine: MENB
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program, IBCC (Inbound Call Center for HCPs), from a contactable nurse practitioner reporting for her son. This 19-year-old male patient received the first single dose of TRUMENBA intramuscular in the left deltoid on an unspecified date during the summer of 2016 for immunization.  The patient medical history was none, concomitant medications were not reported.  No other vaccines were given the same day or within four weeks. The patient experienced redness (four to five inches redness induration) and pain at the injection site the same day of vaccination. Therapeutic measures were taken as a result of the events and included the administration of ibuprofen (MOTRIN). No Emergency room or physician's visit and no relevant tests were performed. The patient recovered on an unspecified date in 2016 after about one week.
Sex: M
Vaccine: TTOX
Symptoms: Allergy to vaccine
Clinical narrative: Initial unsolicited report received from a physician via other company, Pfizer (Reference number- 2017052032) on 22-Feb-2017. This case involves a male patient (age was not reported) who was vaccinated with TETANUS TOXOID (lot number, expiration date, route of administration, site of administration, dose and dose in series were not reported) on an unspecified day. The medical history and the concomitant medications were not reported. On an unknown day, following the vaccination, the patient developed allergy to tetanus. The laboratory test and the corrective treatment was not reported. The outcome of the event was unknown. List of the documents held by sender: none.
Sex: M
Vaccine: DTAP
Symptoms: Diarrhoea, Hypersensitivity, Rash
Clinical narrative: Initial unsolicited report received from physician via Pfizer (manufacturer report number: 2017050313) on 22 Feb 2017. This case involves two-month-old male patient who was vaccinated with a dose of DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (DTAP vaccine) (Batch number, expiration date, dose, route and site of administration was not reported) on 06 Jan 2017. The patient's medical history and concomitant medications was not reported. On 07 Jan 2017, one day following the vaccination, the patient experienced bad rash and diarrhea and went to emergency room. On 08 Jan 2017, patient was back in the ER as rash had progressed. Lab data was not reported. The patient received corrective treatment with topical steroids. On 09 Jan 2017, the patient was recovering from the event (reported as "he was better"). List of documents held by sender: none.
Sex: U
Vaccine: FLUX
Symptoms: Influenza, Malaise
Clinical narrative: Initial unsolicited case received from a consumer via other company Pfizer under the Manufacturer Report number: 2017058504 on 23 Feb 2017. This case involves 3 patients (age and gender not reported) who was vaccinated with a dose of INFLUENZA VACCINE (FLU SHOT) (Batch number, expiry date, dose, dose in series, route and site of administration was not reported) on an unknown date. The patients' medical history and concomitant medications were not reported. On an unknown date after the vaccination, the patients are sick with flu. It was reported as the patients received the flu shot every year and every single year they were sick with flu. The patient's lab tests and corrective treatment was not reported. The outcome of the event was not reported. List of documents held by sender: none.
Age: 38.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Asthenia, Back pain, Balance disorder, Blood test, Muscular weakness
Clinical narrative: Initial unsolicited report received from other non-health care professional on 23 Feb 2017. This case involves a 38-year-old male patient who was vaccinated with first dose of ADACEL (Batch number: U5533AA, expiration date, dose and route was not reported) in the left deltoid on 02 Feb 2017. Any other vaccinations within four weeks of vaccinations and Illness at time of vaccination were reported as none. The patient had a medical history of traumatic brain injury with physical and speech deficits. On 06 Feb 2017, four days following the vaccination, the patient had experienced bilateral arm soreness across shoulders and down back, leg weakness, generalized weakness, bilateral tinitus which is getting worse daily, balance issues and difficulty with speech. It was reported that, the patient has been seen in the office many times and referred to a neurologist. Patient required emergency visit. Lab data includes blood work and urine (negative) and spinal tap (refused). It was reported that all exams found no change physically from the patient's baseline. Corrective treatment was not reported. The patient was not recovered from the events. List of documents held by sender: none.
Age: 38.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Musculoskeletal pain, Pain in extremity, Speech disorder, Tinnitus, Urine analysis normal
Clinical narrative: Initial unsolicited report received from other non-health care professional on 23 Feb 2017. This case involves a 38-year-old male patient who was vaccinated with first dose of ADACEL (Batch number: U5533AA, expiration date, dose and route was not reported) in the left deltoid on 02 Feb 2017. Any other vaccinations within four weeks of vaccinations and Illness at time of vaccination were reported as none. The patient had a medical history of traumatic brain injury with physical and speech deficits. On 06 Feb 2017, four days following the vaccination, the patient had experienced bilateral arm soreness across shoulders and down back, leg weakness, generalized weakness, bilateral tinitus which is getting worse daily, balance issues and difficulty with speech. It was reported that, the patient has been seen in the office many times and referred to a neurologist. Patient required emergency visit. Lab data includes blood work and urine (negative) and spinal tap (refused). It was reported that all exams found no change physically from the patient's baseline. Corrective treatment was not reported. The patient was not recovered from the events. List of documents held by sender: none.
Age: 38.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Asthenia, Back pain, Balance disorder, Blood test normal, Injection site pain
Clinical narrative: Initial unsolicited report received from other non-health care professional on 23 Feb 2017. This case involves a 38-year-old male patient who was vaccinated with first dose of ADACEL (Batch number: U5533AA, expiration date, dose and route was not reported) in the left deltoid on 02 Feb 2017. Any other vaccinations within four weeks of vaccinations and Illness at time of vaccination were reported as none. The patient had a medical history of traumatic brain injury with physical and speech deficits. On 06 Feb 2017, four days following the vaccination, the patient had experienced bilateral arm soreness across shoulders and down back, leg weakness, generalized weakness, bilateral tinitus which is getting worse daily, balance issues and difficulty with speech. It was reported that, the patient has been seen in the office many times and referred to a neurologist. Patient required emergency visit. Lab data includes blood work and urine (negative) and spinal tap (refused). It was reported that all exams found no change physically from the patient's baseline. Corrective treatment was not reported. The patient was not recovered from the events. List of documents held by sender: none.
Age: 38.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Muscular weakness, Musculoskeletal pain, Pain in extremity, Speech disorder, Tinnitus
Clinical narrative: Initial unsolicited report received from other non-health care professional on 23 Feb 2017. This case involves a 38-year-old male patient who was vaccinated with first dose of ADACEL (Batch number: U5533AA, expiration date, dose and route was not reported) in the left deltoid on 02 Feb 2017. Any other vaccinations within four weeks of vaccinations and Illness at time of vaccination were reported as none. The patient had a medical history of traumatic brain injury with physical and speech deficits. On 06 Feb 2017, four days following the vaccination, the patient had experienced bilateral arm soreness across shoulders and down back, leg weakness, generalized weakness, bilateral tinitus which is getting worse daily, balance issues and difficulty with speech. It was reported that, the patient has been seen in the office many times and referred to a neurologist. Patient required emergency visit. Lab data includes blood work and urine (negative) and spinal tap (refused). It was reported that all exams found no change physically from the patient's baseline. Corrective treatment was not reported. The patient was not recovered from the events. List of documents held by sender: none.
Age: 38.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Urine analysis normal
Clinical narrative: Initial unsolicited report received from other non-health care professional on 23 Feb 2017. This case involves a 38-year-old male patient who was vaccinated with first dose of ADACEL (Batch number: U5533AA, expiration date, dose and route was not reported) in the left deltoid on 02 Feb 2017. Any other vaccinations within four weeks of vaccinations and Illness at time of vaccination were reported as none. The patient had a medical history of traumatic brain injury with physical and speech deficits. On 06 Feb 2017, four days following the vaccination, the patient had experienced bilateral arm soreness across shoulders and down back, leg weakness, generalized weakness, bilateral tinitus which is getting worse daily, balance issues and difficulty with speech. It was reported that, the patient has been seen in the office many times and referred to a neurologist. Patient required emergency visit. Lab data includes blood work and urine (negative) and spinal tap (refused). It was reported that all exams found no change physically from the patient's baseline. Corrective treatment was not reported. The patient was not recovered from the events. List of documents held by sender: none.