chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to multiple unspecified patients (demographics unknown). The patients' pertinent medical history and concurrent conditions were not provided. On unspecified dates, the patients were administered doses of improperly stored GARDASIL 9 (Lot # L048237 and expiration date: 08-MAY-2017; Lot# L024993 and expiration date: 17-OCT-2017; Lot# L044475 and expiration date: 12-MAY-2017) (dose and route not provided). Concomitant medications were not provided. No adverse effects were reported. It was reported the following temperature excursion for the administered vaccines: 31.5 F for 3.5 hours. No previous temperature excursion was reported. The call was because of a data logger. This is one of several reports received from the same source. Additional information has been requested.
Age: 0.25
Sex: F
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Registered Nurse referring to a patient of unknown age and gender. Information about the patient's medical history and concurrent conditions was not provided. On 29-FEB-2016, the patient was vaccinated with an improperly stored (Temperature: 32F-Time Frame: 5 minutes) dose of ROTATEQ (lot # L013202 and expiration date: 27-JAN-2017, orally). No concomitant therapies were reported. NO adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 0.5
Sex: F
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Registered Nurse referring to a patient of unknown age and gender. Information about the patient's medical history and concurrent conditions was not provided. On 15-MAR-2016, the patient was vaccinated with an improperly stored (temperature: 32F - Time frame: 5 minutes) dose of ROTATEQ (lot # L013202 and expiration date: 27-JAN-2017, orally. No concomitant therapies were reported. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant referring to unspecified number of patients of unknown age and gender. The patients' concurrent conditions and medical history were not provided. On unknown dates, the patients were vaccinated with the improperly stored doses of ROTATEQ (orally lot #: L026741, expiration date on 18-MAY-2017; dose was not reported. The vaccines were stored in a temperature of 27F during 15 hours. No adverse events were reported. No previous temperature excursion was reported. No product quality complaint 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 Registered Nurse referring to a patient of unknown age and gender. Information about the patient's medical history and concurrent conditions was not provided. On 17-FEB-2016, the patient was vaccinated with an improperly stored (Temperature: 32F - Time frame: 5 minutes) dose of VAQTA (lot # L023232 and expiration date: 25-FEB-2017, administration route was not provided). NO concomitant therapies were reported. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 1.92
Sex: M
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Registered  Nurse referring to a patient of unknown age and gender. Information about the patient's medical history and concurrent conditions was not reported. On 26-FEB-2016, the patient was vaccinated with an improperly stored (Temperature: 32F - Time frame: 5 minutes) dose of VAQTA (lot # L023232 and expiration date: 25-FEB-2017 (administration route was not provided). No concomitant therapies were reported. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Registered Nurse referring to a patient of unknown age and gender. Information about the patient's medical history and concurrent conditions was not provided. On 10-MAR-2016, the patient was vaccinated with an improperly stored (Temperature: 32F - Time frame: 5 minutes) dose of VAQTA (lot # L023232 and expiration date: 25-FEB-2016, administration route was not provided). No concomitant therapies were reported. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Registered Nurse referring to a patient of unknown age and gender. Information about the patient's medical history and concurrent conditions was not provided. On 21-MAR-2016, the patient was vaccinated with an improperly stored (Temperature: 32F - Time frame: 5 minutes) dose of VAQTA (lot # L023232 and expiration date: 25-FEB-2016, administration route was not provided). No concomitant therapies were reported. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: PNC13, TDAP, VARZOS
Symptoms: Fatigue, Mobility decreased
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 68 year old female patient. The patient's concurrent condition include bipolar disorder, gastroesophageal reflux disease, hyperlipidemia and hypothyroidism and her medical history included bronchitis. The patient had not any drug reaction or allergies. On 22-APR-2016, the patient was vaccinated with ZOSTAVAX (lot # L039126, expiry date 18-JAN-2017 (dose, route and frequency  were not reported.); and laos with BOOSTRIX. Concomitant therapies included RISPERDAL and LAMICTAl. On the same date, since the patient received the vaccination, she experienced extreme fatigue and she "could not get out of bed". The patient visited the pharmacy, regarding the adverse events. No treatment was given an no laboratory studies were performed. No product quality complaint (PQC) was involved. At the time of reporting, the outcome of fatigue and movement disorder was reported as not recovered. The reporter did not provide a causality assessment between the events and the suspect vaccines. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender. On unknown dates the patient was vaccinated with the 1st and 2nd dose of the RECOMBIVAX HB, injection (strength, dose, route and lot # not reported). respectively. Subsequently, on an unknown date the patient received her 3rd dose of RECOMBIVAX HB, 6 months after the 2nd dose (inappropriate schedule of drug administered). No adverse events reported. Additional information has been requested.
Age: 1.25
Sex: M
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Registered Nurse referring to a patient of unknown age and gender. Information about the patient's medical history and concurrent conditions was not provided. On 06-MAR-2016, the patient was vaccinated with an improperly stored (Temperature: 32F - Time frame: 5 minutes) dose of VAQTA (lot # L023232 and expiration date: 25-FEB-2017, administration route was not provided). No concomitant therapies were reported. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to multiple unspecified patients of unknown age and gender. The patient's concurrent conditions and medical history were not provided. It was reported that improperly stored doses of M-M-R II (lot # L012482, expiry date 10-APR-2017, dose and route were not reported) were given to unspecified multiple patients on 07-APR-2016. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a  licensed practical nurse and refers to multiple unspecified patients of unknown age and gender. The patients' concurrent conditions and medical history were not provided. It was reported that improperly stored doses of ROTATEQ (lot # L028645, expiry date 25-MAY-2017, orally (dose was not reported) were given to unspecified multiple patients on 07-APR-2016. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to multiple unspecified patients of unknown age and gender. The patients' concurrent conditions and medical history were not provided. It was reported that improperly stored doses of RECOMBIVAX HB L044694, expiry date 04-FEB-2018, (dose and route were not reported), were given to unspecified multiple patients on 07-APR-2016. No adverse effects were reported. No product quality complain (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 46.0
Sex: F
Vaccine: PPV
Symptoms: Injection site bruising, Injection site pain
Clinical narrative: Bruising and pain in upper left arm since yesterday. PA advised rest, heat pad and NSAID OTC for the new few days.
Age: 1.04
Sex: F
Vaccine: MMR
Symptoms: Measles, Rash
Clinical narrative: Information has been received from a registered nurse referring to a 1 years old female patient. There was no pertinent medical history, concomitant drug or drug reaction/allergies of the patient. On 28-MAR-2016 the patient was vaccinated with a dose of M-M-R II (Lot# was reported as L0277432, expiration date was reported as 22-JUL-2017, dose and strength were not reported) subcutaneously. The patient had an unspecified rash on an unspecified area of her body for 3 days in 2016 which was getting worse. Her parents sought medical attention by contacting the office after the rash had appeared and the patient was then seen in the office on 08-APR-2016 where a physician stated the rash appeared to be a measles-like rash and gave the patient the diagnosis of measles. No treatment was given and no lab diagnostics studies were performed. Outcome of the event and the causality were not reported. It has been confirmed that lot# L0277432 was not valid for M-M-R II. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS, HEPA, JEVX, VARZOS
Symptoms: Injection site reaction, Injection site warmth, Urticaria
Clinical narrative: Area of injection warm. Welt on injection site per patient about 6 inch per call.
Age: 66.0
Sex: F
Vaccine: VARZOS, HEPA, JEVX, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site warmth, Urticaria
Clinical narrative: Area of injection warm. Welt on injection site per patient about 6 inch per call.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Fatigue, Injection site erythema, Injection site pruritus, Injection site rash
Clinical narrative: Pt experienced dizziness, fatigue; general malaise for 3-4 days post vaccine. Pt noticed rash, erythema, itchiness at the injection site.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: Pt experienced dizziness, fatigue; general malaise for 3-4 days post vaccine. Pt noticed rash, erythema, itchiness at the injection site.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV, DTAPIPV, MMRV
Symptoms: Rash, Swelling face, Vomiting
Clinical narrative: After discharged from clinic, pt. taken to ED by parent due to emesis, facial swelling and rash.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV, DTAPIPV, MMRV
Symptoms: Abdominal pain, Swelling, Urticaria
Clinical narrative: After discharged from clinic, pt. taken to ED by parent due to emesis, facial swelling and rash.
Age: 55.0
Sex: M
Vaccine: PPV
Symptoms: Arthralgia, Injection site pain, Injection site swelling
Clinical narrative: Patient reported that a few hours after the injection that he had a significant amount of swelling and pain in the upper left arm in the area surrounding the injection site. This had improved by the afternoon following, but the patient still complained of pain in the left elbow area.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to multiple unspecified patients (demographics unknown). The patients' pertinent medical history and concurrent conditions were not provided. On unspecified dates, the patients were administered doses of improperly stored ROTATEQ (Lot # L037921 and expiration date: 31-MAY-2017; Lot # L035636 and expiration date: 21-MAY-2017), orally (dose not provided). Concomitant medications were not provided. No adverse effects were reported. It was reported the following temperature excursion for the administered vaccines: 31.5 F for 3.5 hours. No previous temperature excursion was reported. The call was because of a data logger. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to unspecified number of unspecified patients of unknown gender and age. Information regarding patients' medical history, concurrent condition, drug reactions/allergies and concomitant therapy were not reported. On unspecified dates in 2016 (reported as starting on or after 09-FEB-2016), the patients were vaccinated with improperly stored doses of M-M-R II (lot # L024036, expiry date: 26-NOV-2016). Nurse stated that the mentioned lot number of the vaccine underwent temperature excursion at 22.7 and -1.2 degree Celsius for 10 hours 8 minutes and 37 hours 6 minutes, respectively. She also reported the details of unsupported vaccine administered to unspecified patients: lot # L019989 (expiry date: 01-JUN-2017; underwent a temperature excursion of 22.7 degree Celsius for 10 hours 8 minutes) was administered on 24-MAR-2016, lot # L032181 (expiry date: 25-AUG-2017; temperature excursion at 22.7 degree Celsius for 10 hours 8 minutes) on 25-MAR-2016, 28-MAR-2016 and 29-MAR-2016. No adverse effect was reported. This is one of the five reports received from the same reporter. This is one of the five reports received from the same reporter. Additional information has been requested.
Age: 1.25
Sex: M
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Registered Nurse referring to a patient of unknown age and gender. Information about the patient's medical history and concurrent conditions was not provided. On 16-FEB-2016, the patient was vaccinated with an improperly stored (Temperature: 32F - Time frame: 5 minutes) dose of RECOMBIVAX HB lot# K009953 and expiration date: 03-APR-2016, (administration route was not provided). No concomitant therapies were reported. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to multiple unspecified patients (demographics unknown). The patients' pertinent medical history and concurrent conditions were not provided. On unspecified dates, the patients were administered doses of improperly stored VAQTA (Lot# K012457; expiration date: 04-JUN-2017) (dose and route not provided). Concomitant medications were not provided. No adverse effects were reported. It was reported the following temperature excursion for the administered vaccines: 31.5 F for 3.5 hours. No previous temperature excursion was reported. The call was because of a data logger. This is one of several reports received from the same source. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Registered Nurse referring to a patient of unknown age and gender. Information about the patient's medical history and concurrent conditions was not provided. On 17-FEB-2016, the patient was vaccinated with an improperly stored (Temperature: 32F - Time frame: 5 minutes) dose of VAQTA lot# L023232 and expiration date: 25-FEB-2017, (administration route was not provided). No concomitant therapies were reported. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 2.0
Sex: F
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Registered Nurse referring to a patient of unknown age and gender. Information about the patient's medical history and concurrent conditions was not provided. On 16-FEB-2016, the patient was vaccinated with an improperly stored (Temperature: 32F - Time frame: 5 minutes) dose of VAQTA lot# L023232 and expiration date: 25-FEB-2017, (administration route was not provided). No concomitant therapies were reported. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 0.33
Sex: F
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Registered Nurse referring to a patient of unknown age and gender. Information about the patient's medical history and concurrent conditions was not provided. On 16-FEB-2016, the patient was vaccinated with an improperly stored (Temperature: 32F - Time frame: 5 minutes) dose of  ROTATEQ lot# L013202 and expiration date: 27-JAN-2017, orally. No concomitant therapies were reported. No adverse effects were reported. This is one of several reports from the same reporter. 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 licensed practical nurse and refers to multiple unspecified patients of unknown age and gender. The patients' concurrent conditions and medical history were not provided. It was reported that improperly stored doses of VAQTA lot number reported as L042660, expiry date 15-MAR-2017 (dose and route were not reported), were given to unspecified multiple patients on 07-APR-2016. No adverse effects were reported. No product quality complain (PQC) was involved. This is one of several reports received from the same reporter. Lot number L042660 is an invalid lot number for VAQTA. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to multiple unspecified patients of unknown age and gender. The patients' concurrent conditions and medical history were not provided. It was reported that improperly stored doses of GARDASIL 9 lot number L026602, expiry date 19-OCT-2017 (dose and route were not reported), were given to unspecified multiple patients on 11-APR-2016. No adverse effects were reported. No product quality complain (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Registered Nurse referring to a patient of unknown age and gender. Information about the patient's medical history and concurrent conditions was not provided. On 11-FEB-2016, the patient was vaccinated with an improperly stored (Temperature: 32F - Time frame: 5 minutes) dose of RECOMBIVAX HB lot# K009953 and expiration date: 03-APR-2016, (administration route was not provided). No concomitant therapies were reported. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Registered Nurse referring to a patient of unknown age and gender. Information about the patient's medical history and concurrent conditions was not provided. On 25-FEB-2016, the patient was vaccinated with an improperly stored (Temperature: 32F - Time frame: 5 minutes) dose of VAQTA lot# L023232 and expiration date: 25-FEB-2017, (administration route was not provided). No concomitant therapies were reported. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 38.0
Sex: F
Vaccine: PNC13, PPV
Symptoms: Chest pain, Chills, Dyspnoea, Electrocardiogram, Immediate post-injection reaction
Clinical narrative: This report was received from Pfizer and was assigned manufacturer report number (US-PFIZER INC-2015389747) for PREVNAR. This was originally reported by a certificated medical assistant, referring to a 38 year old female patient which abstains from alcohol. There were no relevant drug history, drug allergies, family history, nor medical history. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX 23, 0.5 ml once intramuscularly, with a lot # of L014876 (strength, dose number, anatomical place of vaccination and expiry date were not provided). Concomitant medications were not reported. On 09-NOV-2015, the aforementioned vaccine shot caused to the patient itching, fever, chills, nausea and vision problems. Additionally, the patient experienced shortness of breath (SOB), chest pains and cellulitis at injection site. As a result of that, she was hospitalized on an unknown date for an unknown duration. Therefore, treatment and specific tests were required but there were not specified. At the time of reporting, the patient recovered on an unknown date of dyspnoea, nausea, chills, pyrexia, injection site pruritus, visual impairment, injection site cellulitis and chest pain. Additionally, the reporter considered injection site pruritus, chest pain, injection site cellulitis, nausea, visual impairment, dyspnoea, chills and pyrexia to be related to PNEUMOVAX 23. As on 02-MAY-2016, all telephone attempts to obtain follow up information have been unsuccessful. This is a new safety report and has been created due to safety report US-009507513-1604USA010439 have been submitted with an incorrect WWID reference US-009507513-1604USA010439 that does not refer to an existing case. US-009507513-1604USA010439 will be nullified. The correct WWID US-PFIZER INC-2015389747 is reference within this safety report and will be kept as the master case file. Additional information has been requested. Narrative was updated.
Age: 38.0
Sex: F
Vaccine: PNC13, PPV
Symptoms: Injection site cellulitis, Injection site pruritus, Injection site reaction, Nausea, Pyrexia
Clinical narrative: This report was received from Pfizer and was assigned manufacturer report number (US-PFIZER INC-2015389747) for PREVNAR. This was originally reported by a certificated medical assistant, referring to a 38 year old female patient which abstains from alcohol. There were no relevant drug history, drug allergies, family history, nor medical history. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX 23, 0.5 ml once intramuscularly, with a lot # of L014876 (strength, dose number, anatomical place of vaccination and expiry date were not provided). Concomitant medications were not reported. On 09-NOV-2015, the aforementioned vaccine shot caused to the patient itching, fever, chills, nausea and vision problems. Additionally, the patient experienced shortness of breath (SOB), chest pains and cellulitis at injection site. As a result of that, she was hospitalized on an unknown date for an unknown duration. Therefore, treatment and specific tests were required but there were not specified. At the time of reporting, the patient recovered on an unknown date of dyspnoea, nausea, chills, pyrexia, injection site pruritus, visual impairment, injection site cellulitis and chest pain. Additionally, the reporter considered injection site pruritus, chest pain, injection site cellulitis, nausea, visual impairment, dyspnoea, chills and pyrexia to be related to PNEUMOVAX 23. As on 02-MAY-2016, all telephone attempts to obtain follow up information have been unsuccessful. This is a new safety report and has been created due to safety report US-009507513-1604USA010439 have been submitted with an incorrect WWID reference US-009507513-1604USA010439 that does not refer to an existing case. US-009507513-1604USA010439 will be nullified. The correct WWID US-PFIZER INC-2015389747 is reference within this safety report and will be kept as the master case file. Additional information has been requested. Narrative was updated.
Age: 38.0
Sex: F
Vaccine: PNC13, PPV
Symptoms: Visual impairment
Clinical narrative: This report was received from Pfizer and was assigned manufacturer report number (US-PFIZER INC-2015389747) for PREVNAR. This was originally reported by a certificated medical assistant, referring to a 38 year old female patient which abstains from alcohol. There were no relevant drug history, drug allergies, family history, nor medical history. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX 23, 0.5 ml once intramuscularly, with a lot # of L014876 (strength, dose number, anatomical place of vaccination and expiry date were not provided). Concomitant medications were not reported. On 09-NOV-2015, the aforementioned vaccine shot caused to the patient itching, fever, chills, nausea and vision problems. Additionally, the patient experienced shortness of breath (SOB), chest pains and cellulitis at injection site. As a result of that, she was hospitalized on an unknown date for an unknown duration. Therefore, treatment and specific tests were required but there were not specified. At the time of reporting, the patient recovered on an unknown date of dyspnoea, nausea, chills, pyrexia, injection site pruritus, visual impairment, injection site cellulitis and chest pain. Additionally, the reporter considered injection site pruritus, chest pain, injection site cellulitis, nausea, visual impairment, dyspnoea, chills and pyrexia to be related to PNEUMOVAX 23. As on 02-MAY-2016, all telephone attempts to obtain follow up information have been unsuccessful. This is a new safety report and has been created due to safety report US-009507513-1604USA010439 have been submitted with an incorrect WWID reference US-009507513-1604USA010439 that does not refer to an existing case. US-009507513-1604USA010439 will be nullified. The correct WWID US-PFIZER INC-2015389747 is reference within this safety report and will be kept as the master case file. Additional information has been requested. Narrative was updated.
Age: 38.0
Sex: F
Vaccine: PNC13, PPV
Symptoms: Chest pain, Chills, Dyspnoea, Injection site cellulitis, Nausea
Clinical narrative: This report was received from Pfizer and was assigned manufacturer report number (US-PFIZER INC-2015389747) for PREVNAR. This was originally reported by a certificated medical assistant, referring to a 38 year old female patient which abstains from alcohol. There were no relevant drug history, drug allergies, family history, nor medical history. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX 23, 0.5 ml once intramuscularly, with a lot # of L014876 (strength, dose number, anatomical place of vaccination and expiry date were not provided). Concomitant medications were not reported. On 09-NOV-2015, the aforementioned vaccine shot caused to the patient itching, fever, chills, nausea and vision problems. Additionally, the patient experienced shortness of breath (SOB), chest pains and cellulitis at injection site. As a result of that, she was hospitalized on an unknown date for an unknown duration. Therefore, treatment and specific tests were required but there were not specified. At the time of reporting, the patient recovered on an unknown date of dyspnoea, nausea, chills, pyrexia, injection site pruritus, visual impairment, injection site cellulitis and chest pain. Additionally, the reporter considered injection site pruritus, chest pain, injection site cellulitis, nausea, visual impairment, dyspnoea, chills and pyrexia to be related to PNEUMOVAX 23. As on 02-MAY-2016, all telephone attempts to obtain follow up information have been unsuccessful. This is a new safety report and has been created due to safety report US-009507513-1604USA010439 have been submitted with an incorrect WWID reference US-009507513-1604USA010439 that does not refer to an existing case. US-009507513-1604USA010439 will be nullified. The correct WWID US-PFIZER INC-2015389747 is reference within this safety report and will be kept as the master case file. Additional information has been requested. Narrative was updated.
Age: 38.0
Sex: F
Vaccine: PNC13, PPV
Symptoms: Pruritus, Pyrexia, Visual impairment
Clinical narrative: This report was received from Pfizer and was assigned manufacturer report number (US-PFIZER INC-2015389747) for PREVNAR. This was originally reported by a certificated medical assistant, referring to a 38 year old female patient which abstains from alcohol. There were no relevant drug history, drug allergies, family history, nor medical history. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX 23, 0.5 ml once intramuscularly, with a lot # of L014876 (strength, dose number, anatomical place of vaccination and expiry date were not provided). Concomitant medications were not reported. On 09-NOV-2015, the aforementioned vaccine shot caused to the patient itching, fever, chills, nausea and vision problems. Additionally, the patient experienced shortness of breath (SOB), chest pains and cellulitis at injection site. As a result of that, she was hospitalized on an unknown date for an unknown duration. Therefore, treatment and specific tests were required but there were not specified. At the time of reporting, the patient recovered on an unknown date of dyspnoea, nausea, chills, pyrexia, injection site pruritus, visual impairment, injection site cellulitis and chest pain. Additionally, the reporter considered injection site pruritus, chest pain, injection site cellulitis, nausea, visual impairment, dyspnoea, chills and pyrexia to be related to PNEUMOVAX 23. As on 02-MAY-2016, all telephone attempts to obtain follow up information have been unsuccessful. This is a new safety report and has been created due to safety report US-009507513-1604USA010439 have been submitted with an incorrect WWID reference US-009507513-1604USA010439 that does not refer to an existing case. US-009507513-1604USA010439 will be nullified. The correct WWID US-PFIZER INC-2015389747 is reference within this safety report and will be kept as the master case file. Additional information has been requested. Narrative was updated.
Sex: U
Vaccine: MMR
Symptoms: Autism, Developmental delay
Clinical narrative: Information has been received from a nurse practitioner via a company representative concerning a child of unknown age and gender. On an unknown date the patient was vaccinated with a dose of M-M-R II (dose, route and lot# was not reported). On an unknown date (it was also reported as a long time ago back when the reporter was in college), the patient had shown developmental issues shortly after taking M-M-R II which might resemble autism. It was unknown if the patient sought medical attention. The outcome of event was unknown. Upon internal view, autism was considered to be medically significant. 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 medical assistant referring to unspecified number of unspecified patients of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On unknown dates starting on or after 22-APR-2016, the patients were administered an unspecified number of improperly stored doses of (Merck) VARIVAX (lot # K021933, expiration date 10-NOV-2016; lot # L037565, expiration date 29-SEP-2017; lot # L045954, expiration date 17-NOV-2017) (dose and route of administration were not reported). The administered doses experienced a temperature excursion of 7 F for 1 hour and 35 minutes. There were no previous excursions. The temperature excursions were detected by a data logger. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report as received from a physician refers to her husband (age unspecified). The patient's concurrent conditions and medical history were not provided. Two months ago, approximately on an unknown date in February, 2016, the reporter's husband was vaccinated with PNEUMOVAX 23 for immunization (dose, route, site of administration and lot# not reported). Concomitant medication was not mentioned by the reporter. On an unspecified date in February, 2016, the patient experienced injection site swelling and injection site erythema. No treatment was necessary for the events. The events injection site erythema and injection site swelling got resolved in 3 days. No further information was provided. Causality statement was not provided by the reporter. Additional information has been requested. This is one of the two reports received from the same reporter.
Age: 80.0
Sex: M
Vaccine: FLU3
Symptoms: Death, Fatigue, Influenza, Pain
Clinical narrative: Based on the additional information received on 07 March 2016, this case initially considered as non-serious was upgraded to serious due to death of the patient. Initial unsolicited report received from a physician on 03 December 2015. This case involves a male patient (age unknown) who was vaccinated with a dose of FLUZONE HD (batch number, expiry date, route, dose in series and site of administration were not reported) on 2 September 2015. Medical history and concomitant medications were not reported. On an unspecified date, following the vaccination patient experienced flu symptoms, exhaustion and body ache. Laboratory investigation and corrective treatment were not reported. The outcome of event was not reported. List of documents held by sender: none. Follow up information received from Physician on 07 March 2016. It was reported that, patient's details could not be obtained as patient died (details not provided) on an unspecified date. Sender's Comments: Initial case, reported events was flu symptoms, exhaustion and body ache with patient has since Deceased (from other reason)" date was not reported and in follow-up reported that patient has since Deceased (from other reason)" date was not reported. limited information was provided in document. Additional information on patient's medical history and concomitant medications, health status at vaccination, final diagnosis and complementary investigations ruling out alternative etiology and autopsy report are needed for complete assessment. Based on available information, role of vaccine cannot be established. Reported Cause(s) of Death: death nos.
Age: 28.0
Sex: M
Vaccine: TDAP
Symptoms: Dizziness, Dyspnoea, Dysstasia, Tinnitus
Clinical narrative: Several hours after vaccine administered, had severe dizziness (unable to stand), tinnitus/ringing in ears, sweating, and difficulty breathing for a short duration (30 seconds?). Vaccine was a Tdap.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to an unspecified  number of patients of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date, the patients were vaccinated with improperly stored doses of PROQUAD (lot # M001152, expiry date 05-JUL-2017 (dose, route of administration and administration site were not specified). Administered doses of PROQUAD, underwent temperature excursion at 75 Fahrenheit degrees for 1 hour and 10 minutes. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. 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 an unspecified number of patients of unknown age and gender. No information regarding the patients' pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date, the patients were vaccinated with improperly stored doses of (Oka/Merck) VARIVAX injection, lot # reported as L048462, expiry date 02-DEC-2017 (dose, route of administration and administration site were not specified). Administered doses of (Oka/Merck) VARIVAX underwent temperature excursion at 75 Fahrenheit degrees for 1 hour and 10 minutes. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date, the patients were vaccinated with improperly stored doses of MMR II injection, lot # L028273, expiry date 28-JUL-2017 (dose, route of administration and administration site were not specified). Administered doses of MMR II underwent temperature excursion at 75 Fahrenheit degrees for 1 hour and 10 minutes. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.42
Sex: U
Vaccine: RV5
Symptoms: Medication error, No adverse event
Clinical narrative: Information has been received from a nurse referring to a 5 month old patient. On 04-MAY-2016, the patient was vaccinated with the first dose of ROTATEQ (dose and route not provided, lot number # reported as L039638, expiration date 23-AUG-2017). No adverse effects were reported. Additional information is not expected as the nurse did not wish to be contacted.
Sex: F
Vaccine: HPV9
Symptoms: Influenza like illness, Pyrexia
Clinical narrative: This spontaneous report has been received from a nurse via field representative referring to a female patient of unknown age. The patient's medical history and concomitant conditions were not informed On an unknown dates the patient was vaccinated with doses of GARDASIL 9, at 0, 2, 6 months. On an unknown date the patient experienced fever and flu like symptoms for an unspecified rason. The patient did not seek medical attention. At the time of the report, the outcome of the event was unknown. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to unspecified number of unspecified patients of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On unknown dates starting on or after 22-APR-2016, the patients were administered an unspecified number of improperly stores doses of ZOSTAVAX (lot # reported as L038929 is an invalid lot number for Zoster Vaccine Live, expiration date 06-JAN-2017) (dose and route of administration were not reported) for prophylaxis. The administered doses experienced a temperature excursion of 7 F for 1 hour and 35 minutes. There were no previous excursions. The temperature excursions were detected by a data logger. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site irritation
Clinical narrative: Injection site irritation.
Age: 17.0
Sex: M
Vaccine: HPV9, MENB
Symptoms: Cough, Haemoglobin normal, Pyrexia, White blood cell count decreased
Clinical narrative: Information has been received from a medical assistant referring to a 17 year old male patient with attention deficit/hyperactivity disorder. The patient had no drug reaction or allergies. On 16-MAR-2016 the patient was vaccinated with the first dose of GARDASIL 9 (lot # L028082, expiration date 18-SEP-2017, intramuscular, dose unknown). Concomitant therapies included a dose of BEXSERO administered on the same day and VYVANSE. Later the same day the patient developed a fever of 100/9 Fahrenheit and a cough. On 17-MAR-2016 the patient's fever increased to 102 Fahrenheit. The patient visited urgent care clinic. On the same day the patient had a blood work drawn which showed his white blood cell count was decreased at 2.9 (unit unknown) and his haemoglobin was decreased 13.8 (unit unknown). Unspecified intravenous fluid bolus and ibuprofen were given as treatment. On unknown dates in March 2016 the patient recovered from the events (reported as resolved with two weeks). The patient intended to continue the GARDASIK 9 series. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: DTAP
Symptoms: Anaphylactic reaction, Cough, Pyrexia, Rash generalised
Clinical narrative: Fever, deep, persistent cough, especially at night, lasting 7 days. Anaphylaxis (sweeping in hands, feet, lips, and full body rash) requiring emergency room and prednisone.
Age: 39.0
Sex: F
Vaccine: HEP, RAB
Symptoms: Dizziness, Electrocardiogram normal, Fatigue, Laboratory test normal, Loss of consciousness
Clinical narrative: Patient reports brief black out period which lasted a few seconds, 1.5 hours after receiving Rabavert # 1 and Hepatitis B # 1.  The black out period included increased dizziness, and change in vision. Per patient she did not faint.  This only occurred once. Patient reports that through out the day on 4/28 and 04/29/ 2016 she felt increased intermittent dizziness and fatigue specifically after meals. Patient traveled the weekend of 04/30 and while there experienced general malaise and increase heart palpitations on Saturday 04/30/2016.  On 04/30/2016 afternoon, Patient went to urgent care where labs and EKG were done.  Per patient, all labs normal and EKG normal. Urgent care physician advised to avoid caffeinated and alcoholic beverages for the next week and to discontinue Rabies series. Urgent care physician did not attribute systemic response to Hepatitis B vaccine and advised that she may continue with the Hepatitis B vaccine series. Urgent care physician advised that patient eat light meals and plenty of fluids.  Patient returned to facility 05/05/16 and reported that symptoms have decreased but she does continue to feel intermittent dizzy spells. Eating lighter meals has alleviated the dizziness per patient. Per patient medical history, she is not pregnant at this time. Patient did not report any localized reaction, no rash, or swelling noted near or at site of injection.
Age: 39.0
Sex: F
Vaccine: HEP, RAB
Symptoms: Malaise, Palpitations, Visual impairment
Clinical narrative: Patient reports brief black out period which lasted a few seconds, 1.5 hours after receiving Rabavert # 1 and Hepatitis B # 1.  The black out period included increased dizziness, and change in vision. Per patient she did not faint.  This only occurred once. Patient reports that through out the day on 4/28 and 04/29/ 2016 she felt increased intermittent dizziness and fatigue specifically after meals. Patient traveled the weekend of 04/30 and while there experienced general malaise and increase heart palpitations on Saturday 04/30/2016.  On 04/30/2016 afternoon, Patient went to urgent care where labs and EKG were done.  Per patient, all labs normal and EKG normal. Urgent care physician advised to avoid caffeinated and alcoholic beverages for the next week and to discontinue Rabies series. Urgent care physician did not attribute systemic response to Hepatitis B vaccine and advised that she may continue with the Hepatitis B vaccine series. Urgent care physician advised that patient eat light meals and plenty of fluids.  Patient returned to facility 05/05/16 and reported that symptoms have decreased but she does continue to feel intermittent dizzy spells. Eating lighter meals has alleviated the dizziness per patient. Per patient medical history, she is not pregnant at this time. Patient did not report any localized reaction, no rash, or swelling noted near or at site of injection.
Age: 37.0
Sex: F
Vaccine: CHOL
Symptoms: Electromyogram abnormal, Muscle spasms, Paraesthesia, Polyneuropathy
Clinical narrative: Paresthesia feet and hands + abdominal muscle spasms.
Age: 88.0
Sex: F
Vaccine: PNC13
Symptoms: Asthenia, Exercise tolerance decreased, Fatigue, Gait disturbance, Inflammatory marker increased
Clinical narrative: Patient complaining of muscle aches and weakness of muscles since vaccination. She can no longer walk the distance she used to, while exercising she gets fatigued easily.
Age: 88.0
Sex: F
Vaccine: PNC13
Symptoms: Muscular weakness, Myalgia
Clinical narrative: Patient complaining of muscle aches and weakness of muscles since vaccination. She can no longer walk the distance she used to, while exercising she gets fatigued easily.
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report was received from a physician of unknown age reporting on herself. She did not have any relevant drug reactions/allergies nor she had any relevant pertinent medical history. On 06-APR-2016 the patient was vaccinated with PNEUMOVAX23, 0.5 ml, intramuscular in the right arm with an hour of this vaccination she experienced redness (injection site swelling), progressing to her right elbow, with no fever. Laboratory diagnostic studies were not performed. She did not receive any treatment for the events. The outcome of injection site erythema and injection site swelling was unknown. No further information was provided. Causality statement was not provided by the reporter. No product quality complaint was filed. Additional information has been requested. This is one of two page reports received from the same reporter.