chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a patient of unknown age and gender. There were no concomitant medications, concurrent conditions and medical history reported. On an unknown date, the patient was vaccinated with VARIVAX (Merck) lot# L017145 exp. 13-MAY-2017 (dose was not reported). The patient received a dose of VARIVAX (Merck) that was stored improperly. There was no adverse effects reported. This is one of several reports received from the same reporter. Additional information is not expected, because the reporter did not wish to be contacted.
Age: 69.0
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, No therapeutic response
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of therapy non-responder in a 69-year-old male patient who received ENGERIX B. Co-suspect products included ENGERIX B and ENGERIX B. On an unknown date, the patient received the 1st dose of ENGERIX B and the 2nd dose of ENGERIX B. In April 2014, the patient received the 3rd dose of ENGERIX B. On an unknown date, an unknown time after receiving ENGERIX B and ENGERIX B and 305 days after receiving ENGERIX B, the patient experienced therapy non-responder. On an unknown date, the outcome of the therapy non-responder was unknown. It was unknown if the reporter considered the therapy non-responder to be related to ENGERIX B, ENGERIX B and ENGERIX B. Additional details provided were as follows: This case was previously reported to the manufacturer. On unspecified dates, the patient received first two doses of ENGERIX B. In April 2014, the patient received his 3rd dose. In February 2015, unknown times after receiving the first two doses and 10 months after receiving the 3rd dose of ENGERIX B, the patient underwent test for Hepatitis B titers, which was found to be negative. This caused the patient to be a non-responder to the therapy.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to unspecified number of patients (age and gender were not reported). On unspecified dates patients were vaccinated with improperly stored doses of VAQTA lot # K019560, expiration date 02-JUN-2017, (dose, dose #, route and application site were not reported). No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to a patient of an unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 28-NOV-2011, the patient was vaccinated with first dose of ZOSTAVAX. On 26-OCT-2015, the patient was vaccinated with second dose of ZOSTAVAX (extra dose administered). No adverse effects were reported. 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 refers to multiple unspecified patients of unknown demographics. The patients concurrent conditions and medical history were not provided. On multiple unspecified dates, the patients were vaccinated with unspecified improperly stored doses of RECOMBIVAX HB lot# K010535 and expiration date 27-AUG-2016 (route of administration and anatomical location were not reported). There were no concomitant medications provided. No adverse effect reported. This is one of several cases from the same reporter. Follow up information has been received on 20-OCt-2015, a phone call was placed to the reporting licensed practical nurse who reported that she would have to research the request made for patients identifiers, lot number and expiration date and dates of vaccination. Additional information has been requested. Narrative has been updated.
Age: 6.0
Sex: M
Vaccine: PPV
Symptoms: Antibody test negative, Peripheral swelling, Skin warm
Clinical narrative: This spontaneous report as received from a nurse refers to a 6 year old male patient with asthma and with no drug reactions or allergies. In approximately October 2014 (reported as "a year ago"), the patient was vaccinated with the first dose of PNEUMOVAX 23 (strength, dose, route of administration, lot# and expiry date unspecified) and on an unspecified date, patient's titers showed that he had no immunity. On 26-OCT-2015, the patient was vaccinated with the second dose of PNEUMOVAX 23 0.5 ml, lot # L022262, expiry date: 05-NOV-2016, intramuscularly. Concomitant therapies included PREVNAR 13 and influenza virus vaccine (unspecified) administered in approximately October 2015 (reported as "within about 2 weeks"). On 27-OCT-2015, the patient's right arm, from shoulder to elbow, was swollen and hot to touch post administration of PNEUMOVAX 23. The mother of patient sought medical attention via a phone call, however, no treatment was given and no laboratory test were performed. The outcome of the events was reported as not recovered. The relatedness between the events and PNEUMOVAX 23 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 nurse refers to an unspecified number of patients of unknown age and gender. The patients' medical history was not reported. On an unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD (Merck) lot # L023112, expiration date reported as 24-DEC-2016, lot # K011311, expiration date reported as 14-FEB-2016, lot # L009209, expiration date reported as 17-SEP-2016. No adverse effect was reported. This is one of several reports from the same report. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse refers to multiple unspecified patients of unknown demographics. The patients concurrent conditions and medical history were not provided. On multiple unspecified dates, the patients were vaccinated with unspecified improperly stored doses GARDASIL lot# J006236 with expiration date 25-FEB-2016 and lot# K005881 with expiration date 14-JAN-2017 (route of administration and anatomical location were not reported). There were no concomitant medications provided. No adverse effect reported. This is one of several cases from the same reporter. Follow up information has been received on 20-OCT-2015, a phone call was placed to the reporting licensed practical nurse who reported that she would have to research the request made for patients identifiers, lot number and expiration date and dates of vaccination. Additional information has been requested.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a 67 year old male patient with anemia, diabetes mellitus and hypertension. No information regarding the patient's medical history or drug reactions and allergies was provided. On 12-OCT-2015, the patient was vaccinated with a dose of ZOSTAVAX, 0.65 ml, subcutaneously, lot number reported as K010968, expiration date: 07-NOV-2015, (injection site was not reported). The patient's concomitant medications included unspecified medications for the treatment of diabetes, anemia and hypertension. On 22-OCT-2015, the patient was diagnosed with shingles. The patient sought medical attention via contacting his physician and was given VALTREX and NORCO for the treatment of the event. The outcome of shingles was unknown at the time of the report. The relatedness between the event and ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. The patients' medical history was not reported. On an unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX (Merck) lot # reported as L025207, expiration date reported as 07-JUL-2017, lot #  L008273, expiration date reported as 11-MAR-2016, lot # L002871, expiration date reported as 27-JAN-2016, lot # K026385, expiration date reported as 15-DEC-2016. No adverse effect was reported. This is one of several reports from the same report. Additional information has been requested.
Sex: F
Vaccine: HPV9
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to an unspecified number of female patients of unknown age. There was no information about the patients' concurrent conditions, concomitant therapies and medical histories provided. On unknown dates, the patients were vaccinated with doses of GARDASIL (dose, frequency, route of administration, lot # and expiration date were not reported). On unknown dates, doses of GARDASIL 9 (dose, frequency, route of administration, lot # and expiration date were not reported) were administered to these patients to complete human papillomavirus (HPV) vaccination series that were started with GARDASIL. There were no adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 16.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to five patients of unknown age and gender. The patient's pertinent medical history and drug reactions/allergies were not reported. On unknown dates, the patients were vaccinated with an improperly stored GARDASIL, lot # L010596 with expiration date 06-APR-2017 (dose and route of administration were not reported). No adverse effects were reported. On 19-OCT-2015 a phone call was placed to the registered nurse who was unable to provide information. Follow up information has been received on 20-OCT-2015. Pertinent identifiers was given. This case refers to a 16 year old patient. On 01-SEP-2015, the patient was vaccinated with the improperly stored GARDASIL. This is one of several cases from the same reporter. Additional information has been requested.
Age: 12.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to five patients of unknown age and gender. The patients' pertinent medical history and drug reactions/allergies were not reported. On unknown dates, the patients were vaccinated with an improperly stored GARDASIL, lot # L010596 with expiration date 06-APR-2017 (dose and route of administration were not reported). No adverse effects were reported. On 19-OCT-2015 a phone call was placed to the registered nurse who was unable to provide information. Follow up information has been received on 20-OCT-2015. Patient identifiers was given. This case refers to a 12 year old patient. On 01-SEP-2015, the patient was vaccinated with the improperly stored GARDASIL. This is one of several cases from the same reporter. Additional information has been requested.
Age: 13.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to five patients of unknown age and gender. The patients' pertinent medical history and drug reactions/allergies were not reported. On unknown dates, the patients were vaccinated with an improperly stored GARDASIL, lot # L010596 with expiration date 06-APR-2017 (dose and route of administration were not reported). No adverse effects were reported. On 19-OCT-2015 a phone call was placed to the registered nurse who was unable to provide information. Follow up information has been received on 20-OCT-2015. Patient identifiers was given. This case refers to a 13 year old patient. On 01-SEP-2015, the patient was vaccinated with the improperly stored GARDASIL. This is one of several cases from the same reporter. Additional information has been requested.
Age: 14.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to five patients of unknown age and gender. The patients' pertinent medical history and drug reactions/allergies were not reported. On unknown dates, the patients were vaccinated with an improperly stored GARDASIL, lot # L010596 with expiration date 06-APR-2017 (dose and route of administration were not reported). No adverse effects were reported. On 19-OCT-2015 a phone call was placed to the registered nurse who was unable to provide information. Follow up information has been received on 20-OCT-2015. Patient identifiers was given. This case refers to a 14 year old patient. On 01-SEP-2015, the patient was vaccinated with the improperly stored GARDASIL. This is one of several cases from the same reporter. Additional information has been requested.
Age: 19.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to five patients of unknown age and gender. The patient's pertinent medical history and drug reactions/allergies were not reported. On unknown dates, the patients were vaccinated with an improperly stored GARDASIL, lot # L010596 with expiration date 06-APR-2017 (dose and route of administration were not reported). No adverse effects were reported. On 19-OCT-2015 a phone call was placed to the registered nurse who was unable to provide information. Follow up information has been received on 20-OCT-2015. Patient identifiers was given. This case refers to a 19 year old patient. On 31-AUG-2015, the patient was vaccinated with the improperly stored GARDASIL. This is one of several cases 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 medical assistant refers to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions and medical history were not reported. On an unspecified dates, in 2015, reported as "starting on or after 18-MAR-2015", the patients were vaccinated with unspecified improperly stored doses of VARIVAX (Merck) (route of administration, anatomical location, lot number and expiration date were not provided). There were no concomitant medications reported. No adverse effect reported. There was no product quality issue involved. This is one of two cases from the same reporter. Additional information has been requested.
Age: 15.0
Sex: M
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: This spontaneous report was received from a physician via company representative refers to a 15 year old male patient. No concurrent condition or medical history was reported. On an unknown date the patient was vaccinated with GARDASIL 9, (subcutaneous, dose not provided). No concomitant therapy was reported. The patient experienced syncope after vaccination. The outcome of syncope was reported as recovering. No product quality issue was involved. This is one of the several reports from the same reporter. Additional information is not expected as the reporter did not wish further contact.
Age: 15.0
Sex: M
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: This spontaneous report was received from a physician via company representative refers to a 15 year old male patient. No concurrent condition or medical history was reported. On an unknown date the patient was vaccinated with GARDASIL 9, (subcutaneous, dose not provided) for HPV prevention. No concomitant therapy was reported. The patient experienced syncope after vaccination. The outcome of syncope was reported as recovering. No product quality issue was involved. This is one of the several reports from the same reporter. Additional information is not expected as the reporter did not wish further contact.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a physician concerning a female patient of unknown age. Patient's historical condition and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with dose number two, 1 month after the first dose and dose number 3 was given 2 months after number one (series completed in two months) of GARDASIL (strength, dose Lot No and expire date were unspecified). There was no concomitant medication described. No adverse event was informed. There was not a product quality complain involved. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: This spontaneous report has been received from a 68 year old female patient via the agency referring to herself who was with chronic obstructive pulmonary disease. On an unknown date the patient was vaccinated with PNEUMOVAX 23 (dose, route and lot# not reported). On an unknown date the patient experienced pain/soreness at injection site pain and sore arm. The events diminished after stopping suspected therapy. Therapy with PNEUMOVAX 23 was restarted and injection site pain and pain in extremity did not recur. The patient was concerning at the site pain and put a little ice on it. The outcome of the patient was unknown. It was unspecified if the patient sought medical attention. The reporter considered injection site pain and pain in extremity to be related to PNEUMOVAX 23. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to an unspecified number of patients of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On an unspecified dates, in 2015, reported as "starting on or after 18-MAR-215", the patients were vaccinated with unspecified improperly stored doses of PROQUAD (Merck) (route of administration, anatomical location, lot number and expiration date were not provided). There were no concomitant medications reported. No adverse effect reported. There was no product quality issue involved. This is one of two cases from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner, refers to a patient of unknown age and gender. Medical history and concurrent conditions were not reported. The nurse practitioner informed that on 22-OCT-2015, the patient was vaccinated with a dose of PNEUMOVAX 23 (route, dosage, strength and lot# were not reported), that expired on 21-OCT-2015. No adverse effect reported. There was not product quality issue. Additional information has been requested.
Age: 10.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to five patients of unknown age and gender. The patients' pertinent medical history and drug reactions/allergies were not reported. On unknown dates, the patients were vaccinated with an improperly stored GARDASIL, lot # L010596 with expiration date 06-APR-2017 (dose and route of administration were not reported). No adverse effects were reported. On 19-OCT-2015 a phone call was placed to the registered nurse who was unable to provide information. Follow up information has been received on 20-OCT-2015. Patient identifiers was given. This case refers to a 10 year old patient. On 01-SEP-2015, the patient was vaccinated with the improperly stored GARDASIL. This is one of several cases from the same reporter. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: MNQ, HPV4, MNQ
Symptoms: Abdominal pain upper, Blood glucose normal, Dyspnoea, Hyperventilation, Hypoaesthesia
Clinical narrative: Initial unsolicited report and follow up information received from a pharmacist on 15-Oct-2015 and additional information on 16 Oct 2015. This case is linked to cases: 2015SA164327, 2015SA166542 and 2015SAS166544 (same reporter). This case involves a 15 years old female patient, who was vaccinated with a second dose of MENACTRA via intramuscular route (manufacturer: Sanofi Pasteur, batch number: U5021AB, expiry date: 14-Jul-2016, site of administration were not provided) and a third dose of GARDASIL via intramuscular route (manufacturer: Merck, batch number: L004014, expiry date and site of administration were not provided) both on 15-Oct-2015. Illness at time of vaccination was not provided and pre-existing physician diagnosed allergies, birth defects, medical conditions were reported as none. Concomitant medications were not provided. On 15-Oct-2015, 30 minutes post vaccination, patient had lower leg paralysis, decreased sensation below knees, felt a burning sensation all over her body (felt like she was on fire), had air hunger and tinnitus. Within 45 minutes after vaccination, the patient developed Bilateral Lower Extremity sensory deficits followed by leg weakness. The patient also experienced "SOB" and stomach aches. The patient returned to the doctor and was evaluated in the parking lot. She said her legs/feet did not work and could not get out of the car. The doctor thought she had a panic attack. The patient was hospitalized on an unspecified date. She was transferred to another hospital with diagnosis of vasovagal reaction. The patient seen by the doctor was noted to be "SOB", with diminished respiratory function as assessed by negative inspiratory force; the patient was transferred to hospital;. The physician had working diagnosis was GBS (Guillain-Barre Syndrome), but acknowledged the acute onset was not supportive of this diagnosis. Patient was previously vaccinated with a first dose of MENACTRA (manufacturer: Sanofi Pasteur, batch number, expiry date, route and site of administration were not provided) in 2011 and a third dose of GARDASIL (manufacturer: Merck, batch number, expiry date, route and site of administration were not provided) on an unspecified date. Laboratory investigations included BP (Blood Pressure), O2 Saturation, and blood  glucose level which was within normal limits, drug screen test which was positive for marijuana. Corrective treatment was not reported. It was reported that the patient required ER/doctor visit. The outcome of the events was unknown. Discharge date was not provided. Documents held by sender: none.
Age: 15.0
Sex: F
Vaccine: MNQ, HPV4, MNQ
Symptoms: Abdominal pain upper, Blood glucose normal, Burning sensation, Drug screen positive, Dyspnoea
Clinical narrative: Initial unsolicited report and follow up information received from a pharmacist on 15-Oct-2015 and additional information on 16 Oct 2015. This case is linked to cases: 2015SA164327, 2015SA166542 and 2015SAS166544 (same reporter). This case involves a 15 years old female patient, who was vaccinated with a second dose of MENACTRA via intramuscular route (manufacturer: Sanofi Pasteur, batch number: U5021AB, expiry date: 14-Jul-2016, site of administration were not provided) and a third dose of GARDASIL via intramuscular route (manufacturer: Merck, batch number: L004014, expiry date and site of administration were not provided) both on 15-Oct-2015. Illness at time of vaccination was not provided and pre-existing physician diagnosed allergies, birth defects, medical conditions were reported as none. Concomitant medications were not provided. On 15-Oct-2015, 30 minutes post vaccination, patient had lower leg paralysis, decreased sensation below knees, felt a burning sensation all over her body (felt like she was on fire), had air hunger and tinnitus. Within 45 minutes after vaccination, the patient developed Bilateral Lower Extremity sensory deficits followed by leg weakness. The patient also experienced "SOB" and stomach aches. The patient returned to the doctor and was evaluated in the parking lot. She said her legs/feet did not work and could not get out of the car. The doctor thought she had a panic attack. The patient was hospitalized on an unspecified date. She was transferred to another hospital with diagnosis of vasovagal reaction. The patient seen by the doctor was noted to be "SOB", with diminished respiratory function as assessed by negative inspiratory force; the patient was transferred to hospital;. The physician had working diagnosis was GBS (Guillain-Barre Syndrome), but acknowledged the acute onset was not supportive of this diagnosis. Patient was previously vaccinated with a first dose of MENACTRA (manufacturer: Sanofi Pasteur, batch number, expiry date, route and site of administration were not provided) in 2011 and a third dose of GARDASIL (manufacturer: Merck, batch number, expiry date, route and site of administration were not provided) on an unspecified date. Laboratory investigations included BP (Blood Pressure), O2 Saturation, and blood  glucose level which was within normal limits, drug screen test which was positive for marijuana. Corrective treatment was not reported. It was reported that the patient required ER/doctor visit. The outcome of the events was unknown. Discharge date was not provided. Documents held by sender: none.
Age: 15.0
Sex: F
Vaccine: MNQ, HPV4, MNQ
Symptoms: Guillain-Barre syndrome, Mobility decreased, Monoplegia, Muscular weakness, Musculoskeletal disorder
Clinical narrative: Initial unsolicited report and follow up information received from a pharmacist on 15-Oct-2015 and additional information on 16 Oct 2015. This case is linked to cases: 2015SA164327, 2015SA166542 and 2015SAS166544 (same reporter). This case involves a 15 years old female patient, who was vaccinated with a second dose of MENACTRA via intramuscular route (manufacturer: Sanofi Pasteur, batch number: U5021AB, expiry date: 14-Jul-2016, site of administration were not provided) and a third dose of GARDASIL via intramuscular route (manufacturer: Merck, batch number: L004014, expiry date and site of administration were not provided) both on 15-Oct-2015. Illness at time of vaccination was not provided and pre-existing physician diagnosed allergies, birth defects, medical conditions were reported as none. Concomitant medications were not provided. On 15-Oct-2015, 30 minutes post vaccination, patient had lower leg paralysis, decreased sensation below knees, felt a burning sensation all over her body (felt like she was on fire), had air hunger and tinnitus. Within 45 minutes after vaccination, the patient developed Bilateral Lower Extremity sensory deficits followed by leg weakness. The patient also experienced "SOB" and stomach aches. The patient returned to the doctor and was evaluated in the parking lot. She said her legs/feet did not work and could not get out of the car. The doctor thought she had a panic attack. The patient was hospitalized on an unspecified date. She was transferred to another hospital with diagnosis of vasovagal reaction. The patient seen by the doctor was noted to be "SOB", with diminished respiratory function as assessed by negative inspiratory force; the patient was transferred to hospital;. The physician had working diagnosis was GBS (Guillain-Barre Syndrome), but acknowledged the acute onset was not supportive of this diagnosis. Patient was previously vaccinated with a first dose of MENACTRA (manufacturer: Sanofi Pasteur, batch number, expiry date, route and site of administration were not provided) in 2011 and a third dose of GARDASIL (manufacturer: Merck, batch number, expiry date, route and site of administration were not provided) on an unspecified date. Laboratory investigations included BP (Blood Pressure), O2 Saturation, and blood  glucose level which was within normal limits, drug screen test which was positive for marijuana. Corrective treatment was not reported. It was reported that the patient required ER/doctor visit. The outcome of the events was unknown. Discharge date was not provided. Documents held by sender: none.
Age: 15.0
Sex: F
Vaccine: MNQ, HPV4, MNQ
Symptoms: Panic attack, Presyncope, Pulmonary function test abnormal, Respiratory disorder, Sensory disturbance
Clinical narrative: Initial unsolicited report and follow up information received from a pharmacist on 15-Oct-2015 and additional information on 16 Oct 2015. This case is linked to cases: 2015SA164327, 2015SA166542 and 2015SAS166544 (same reporter). This case involves a 15 years old female patient, who was vaccinated with a second dose of MENACTRA via intramuscular route (manufacturer: Sanofi Pasteur, batch number: U5021AB, expiry date: 14-Jul-2016, site of administration were not provided) and a third dose of GARDASIL via intramuscular route (manufacturer: Merck, batch number: L004014, expiry date and site of administration were not provided) both on 15-Oct-2015. Illness at time of vaccination was not provided and pre-existing physician diagnosed allergies, birth defects, medical conditions were reported as none. Concomitant medications were not provided. On 15-Oct-2015, 30 minutes post vaccination, patient had lower leg paralysis, decreased sensation below knees, felt a burning sensation all over her body (felt like she was on fire), had air hunger and tinnitus. Within 45 minutes after vaccination, the patient developed Bilateral Lower Extremity sensory deficits followed by leg weakness. The patient also experienced "SOB" and stomach aches. The patient returned to the doctor and was evaluated in the parking lot. She said her legs/feet did not work and could not get out of the car. The doctor thought she had a panic attack. The patient was hospitalized on an unspecified date. She was transferred to another hospital with diagnosis of vasovagal reaction. The patient seen by the doctor was noted to be "SOB", with diminished respiratory function as assessed by negative inspiratory force; the patient was transferred to hospital;. The physician had working diagnosis was GBS (Guillain-Barre Syndrome), but acknowledged the acute onset was not supportive of this diagnosis. Patient was previously vaccinated with a first dose of MENACTRA (manufacturer: Sanofi Pasteur, batch number, expiry date, route and site of administration were not provided) in 2011 and a third dose of GARDASIL (manufacturer: Merck, batch number, expiry date, route and site of administration were not provided) on an unspecified date. Laboratory investigations included BP (Blood Pressure), O2 Saturation, and blood  glucose level which was within normal limits, drug screen test which was positive for marijuana. Corrective treatment was not reported. It was reported that the patient required ER/doctor visit. The outcome of the events was unknown. Discharge date was not provided. Documents held by sender: none.
Age: 15.0
Sex: F
Vaccine: MNQ, HPV4, MNQ
Symptoms: Sensory loss, Tinnitus
Clinical narrative: Initial unsolicited report and follow up information received from a pharmacist on 15-Oct-2015 and additional information on 16 Oct 2015. This case is linked to cases: 2015SA164327, 2015SA166542 and 2015SAS166544 (same reporter). This case involves a 15 years old female patient, who was vaccinated with a second dose of MENACTRA via intramuscular route (manufacturer: Sanofi Pasteur, batch number: U5021AB, expiry date: 14-Jul-2016, site of administration were not provided) and a third dose of GARDASIL via intramuscular route (manufacturer: Merck, batch number: L004014, expiry date and site of administration were not provided) both on 15-Oct-2015. Illness at time of vaccination was not provided and pre-existing physician diagnosed allergies, birth defects, medical conditions were reported as none. Concomitant medications were not provided. On 15-Oct-2015, 30 minutes post vaccination, patient had lower leg paralysis, decreased sensation below knees, felt a burning sensation all over her body (felt like she was on fire), had air hunger and tinnitus. Within 45 minutes after vaccination, the patient developed Bilateral Lower Extremity sensory deficits followed by leg weakness. The patient also experienced "SOB" and stomach aches. The patient returned to the doctor and was evaluated in the parking lot. She said her legs/feet did not work and could not get out of the car. The doctor thought she had a panic attack. The patient was hospitalized on an unspecified date. She was transferred to another hospital with diagnosis of vasovagal reaction. The patient seen by the doctor was noted to be "SOB", with diminished respiratory function as assessed by negative inspiratory force; the patient was transferred to hospital;. The physician had working diagnosis was GBS (Guillain-Barre Syndrome), but acknowledged the acute onset was not supportive of this diagnosis. Patient was previously vaccinated with a first dose of MENACTRA (manufacturer: Sanofi Pasteur, batch number, expiry date, route and site of administration were not provided) in 2011 and a third dose of GARDASIL (manufacturer: Merck, batch number, expiry date, route and site of administration were not provided) on an unspecified date. Laboratory investigations included BP (Blood Pressure), O2 Saturation, and blood  glucose level which was within normal limits, drug screen test which was positive for marijuana. Corrective treatment was not reported. It was reported that the patient required ER/doctor visit. The outcome of the events was unknown. Discharge date was not provided. Documents held by sender: none.
Age: 56.0
Sex: M
Vaccine: FLU4, FLUX
Symptoms: Injected limb mobility decreased
Clinical narrative: I received a flu shot on September 8, 2015 at the Pharmacy. I felt just a little discomfort but no more than I expected. The next day my left arm I received the shot in. Felt like I received a tetanus shot, my arm was stiff and sore. Gradually the stiffness seem to subside over the next few days, until I moved my upper arm where I received the flu shot, then I had extreme pain it would last a minute or two then slowly subside over the next 5 to 10 minutes unless I moved it to far then it would bother me for 2 to 5 hours. At this time October 30th. I still have the same discomfort in my upper arm when I move it over my head to put on my shirt, or behind me when I lace my belt, or even when I put my arm around my wife. I never had a problem with my arm, flu shots over the years, or any allergies. IF ANYONE KNOWS WHAT I SHOULD DO TO CORRECT THIS PLEASE LET ME KNOW.
Age: 56.0
Sex: M
Vaccine: FLU4, FLUX
Symptoms: Limb discomfort, Musculoskeletal stiffness, Pain, Pain in extremity
Clinical narrative: I received a flu shot on September 8, 2015 at the Pharmacy. I felt just a little discomfort but no more than I expected. The next day my left arm I received the shot in. Felt like I received a tetanus shot, my arm was stiff and sore. Gradually the stiffness seem to subside over the next few days, until I moved my upper arm where I received the flu shot, then I had extreme pain it would last a minute or two then slowly subside over the next 5 to 10 minutes unless I moved it to far then it would bother me for 2 to 5 hours. At this time October 30th. I still have the same discomfort in my upper arm when I move it over my head to put on my shirt, or behind me when I lace my belt, or even when I put my arm around my wife. I never had a problem with my arm, flu shots over the years, or any allergies. IF ANYONE KNOWS WHAT I SHOULD DO TO CORRECT THIS PLEASE LET ME KNOW.
Age: 66.0
Sex: M
Vaccine: FLU3, PNC13, FLUX, PNC13
Symptoms: Blood glucose, Loss of consciousness, Respiratory arrest, Unresponsive to stimuli
Clinical narrative: This is a spontaneous report from a contactable pharmacist, who reported for the same vaccines (from the same lot) for two different patients. This is one of the two reports. A 66-year-old male patient received on 20Oct2015 PREVNAR 13 (lot M13067; expiration date Mar2017), intramuscular at 0.5 ml, single and afterwards received flu shot. Medical history included high blood pressure and high cholesterol. Concomitant medication included atorvastatin 20 mg 1x/day (one at bed time), HCTZ 5 mg, one daily, atenolol 25 (unknown unit) one daily and lisinopril 5 (unknown unit) one daily. On 20Oct2015 within minutes of giving the vaccine, the patient stopped breathing for about 30-45 seconds, lost consciousness and was unresponsive: the chest was pressed to force exhalation and patient regained consciousness by the time paramedic arrived. Pharmacist further added that as the flu shot was being given, the patient said that he was feeling dizzy and after flu shot was administered, he did not respond. Reporter clarified and that PREVNAR 13 and flu shot were given on the same day, just couple of minutes apart. The final outcome of the events was unknown. Pharmacist believed that stopped breathing and lost consciousness were due to PREVNAR 13.
Age: 66.0
Sex: M
Vaccine: FLU3, PNC13, FLUX, PNC13
Symptoms: Dizziness, Loss of consciousness, Respiratory arrest, Unresponsive to stimuli
Clinical narrative: This is a spontaneous report from a contactable pharmacist, who reported for the same vaccines (from the same lot) for two different patients. This is one of the two reports. A 66-year-old male patient received on 20Oct2015 PREVNAR 13 (lot M13067; expiration date Mar2017), intramuscular at 0.5 ml, single and afterwards received flu shot. Medical history included high blood pressure and high cholesterol. Concomitant medication included atorvastatin 20 mg 1x/day (one at bed time), HCTZ 5 mg, one daily, atenolol 25 (unknown unit) one daily and lisinopril 5 (unknown unit) one daily. On 20Oct2015 within minutes of giving the vaccine, the patient stopped breathing for about 30-45 seconds, lost consciousness and was unresponsive: the chest was pressed to force exhalation and patient regained consciousness by the time paramedic arrived. Pharmacist further added that as the flu shot was being given, the patient said that he was feeling dizzy and after flu shot was administered, he did not respond. Reporter clarified and that PREVNAR 13 and flu shot were given on the same day, just couple of minutes apart. The final outcome of the events was unknown. Pharmacist believed that stopped breathing and lost consciousness were due to PREVNAR 13.
Age: 78.0
Sex: M
Vaccine: FLU3, PNC13, FLU3, PNC13
Symptoms: Blood test, Fluid overload, Full blood count abnormal, Metabolic function test abnormal, Swelling
Clinical narrative: Initial unsolicited report received from a health care professional (practice manager calling on behalf of physician) via other pharmaceutical company on 21 October 2015. This case involves a 78-year-old male patient who was vaccinated with an intramuscular [dose in series were not reported] 0.5 ml dose of FLUZONE HIGH DOSE vaccine (batch number UI4278A, expiry date 28 March 2016) in left deltoid and also received intramuscular [dose in series were not reported] 0.5 ml dose of PREVNAR 13 (frequency once, batch number L84631, expiry date 01-FEB-2017) in right deltoid and both vaccine administered on 11 September 2015 (11:30 AM). It was unknown if the patient was given any other vaccine four weeks prior to the vaccination. Other medical history included hypertension, diabetes, leukemia, chronic kidney disease, anxiety, blood pressure and high cholesterol. Concomitant medications were JANUVIA 50 mg for Diabetes, Lisinopril 40 mg for chronic kidney disease, XANAX 2 mg for anxiety, NORVASC 10 mg for hypertension, COREG 25 mg for blood pressure, Fenofibrate 160 mg for high cholesterol, PRAVACHOL: 20 mg for cholesterol. On 12 September 2015, one day following the vaccination, the patient had experienced swelling over his entire body, swelling and fluid was so much that the patient could not fit into his clothes. It was reported that patient noticed the problem in the morning when he woke up. On an unspecified date patient was hospitalized. On 06 October 2015, patient had some blood work and complete blood count (CBC) and basic metabolic panel (BMP) both were abnormal. Corrective treatment was LASIX 40 mg, tablets, one twice a day orally. The outcome of event was not recovered (event come down some but still continued to have swelling). On an unspecified date patient was discharged from the hospital. Physician feels that patient's swelling was due to leukemia. Reporter assessed the Causality as no. List of documents held by sender: none.
Age: 78.0
Sex: M
Vaccine: FLU3, PNC13, FLU3, PNC13
Symptoms: Blood test, Condition aggravated, Fluid retention, Full blood count abnormal, Leukaemia
Clinical narrative: Initial unsolicited report received from a health care professional (practice manager calling on behalf of physician) via other pharmaceutical company on 21 October 2015. This case involves a 78-year-old male patient who was vaccinated with an intramuscular [dose in series were not reported] 0.5 ml dose of FLUZONE HIGH DOSE vaccine (batch number UI4278A, expiry date 28 March 2016) in left deltoid and also received intramuscular [dose in series were not reported] 0.5 ml dose of PREVNAR 13 (frequency once, batch number L84631, expiry date 01-FEB-2017) in right deltoid and both vaccine administered on 11 September 2015 (11:30 AM). It was unknown if the patient was given any other vaccine four weeks prior to the vaccination. Other medical history included hypertension, diabetes, leukemia, chronic kidney disease, anxiety, blood pressure and high cholesterol. Concomitant medications were JANUVIA 50 mg for Diabetes, Lisinopril 40 mg for chronic kidney disease, XANAX 2 mg for anxiety, NORVASC 10 mg for hypertension, COREG 25 mg for blood pressure, Fenofibrate 160 mg for high cholesterol, PRAVACHOL: 20 mg for cholesterol. On 12 September 2015, one day following the vaccination, the patient had experienced swelling over his entire body, swelling and fluid was so much that the patient could not fit into his clothes. It was reported that patient noticed the problem in the morning when he woke up. On an unspecified date patient was hospitalized. On 06 October 2015, patient had some blood work and complete blood count (CBC) and basic metabolic panel (BMP) both were abnormal. Corrective treatment was LASIX 40 mg, tablets, one twice a day orally. The outcome of event was not recovered (event come down some but still continued to have swelling). On an unspecified date patient was discharged from the hospital. Physician feels that patient's swelling was due to leukemia. Reporter assessed the Causality as no. List of documents held by sender: none.
Age: 78.0
Sex: M
Vaccine: FLU3, PNC13, FLU3, PNC13
Symptoms: Metabolic function test abnormal, Swelling
Clinical narrative: Initial unsolicited report received from a health care professional (practice manager calling on behalf of physician) via other pharmaceutical company on 21 October 2015. This case involves a 78-year-old male patient who was vaccinated with an intramuscular [dose in series were not reported] 0.5 ml dose of FLUZONE HIGH DOSE vaccine (batch number UI4278A, expiry date 28 March 2016) in left deltoid and also received intramuscular [dose in series were not reported] 0.5 ml dose of PREVNAR 13 (frequency once, batch number L84631, expiry date 01-FEB-2017) in right deltoid and both vaccine administered on 11 September 2015 (11:30 AM). It was unknown if the patient was given any other vaccine four weeks prior to the vaccination. Other medical history included hypertension, diabetes, leukemia, chronic kidney disease, anxiety, blood pressure and high cholesterol. Concomitant medications were JANUVIA 50 mg for Diabetes, Lisinopril 40 mg for chronic kidney disease, XANAX 2 mg for anxiety, NORVASC 10 mg for hypertension, COREG 25 mg for blood pressure, Fenofibrate 160 mg for high cholesterol, PRAVACHOL: 20 mg for cholesterol. On 12 September 2015, one day following the vaccination, the patient had experienced swelling over his entire body, swelling and fluid was so much that the patient could not fit into his clothes. It was reported that patient noticed the problem in the morning when he woke up. On an unspecified date patient was hospitalized. On 06 October 2015, patient had some blood work and complete blood count (CBC) and basic metabolic panel (BMP) both were abnormal. Corrective treatment was LASIX 40 mg, tablets, one twice a day orally. The outcome of event was not recovered (event come down some but still continued to have swelling). On an unspecified date patient was discharged from the hospital. Physician feels that patient's swelling was due to leukemia. Reporter assessed the Causality as no. List of documents held by sender: none.
Age: 1.25
Sex: M
Vaccine: DTAPIPVHIB, FLU3, VARCEL
Symptoms: Injection site erythema, Injection site urticaria
Clinical narrative: Immediately after patient received 3 shots, I nursed him for comfort. About 5 minutes after, I went to dress him and saw the skin where 1 shot was given was very red and the redness was spreading outward from band aid. I called Dr to take a look. She removed the band aid and there was one hive at the injection site. It was about the size of an M&M candy. She listened to his heart and respiration and gave him 3.75 ml of Benadryl. Patient seemed fine and the hive was gone that evening.
Age: 3.0
Sex: M
Vaccine: FLUX
Symptoms: Urticaria
Clinical narrative: Giant hives on legs, left arm, and neck. Benadryl was given along with calamine lotion topically.
Age: 45.0
Sex: F
Vaccine: FLUX
Symptoms: Back pain, Feeling abnormal, Insomnia, Lethargy, Spinal pain
Clinical narrative: At first I became increasingly lethargic then started having bad back pain. The pain became increasingly worse which was in my whole spine. This pain was like nothing I had ever experienced before. It was not relieved by pain meds, stretching or sleep. The excruciating pain did not allow me to sleep. This pain lasted for 5 days and has just barely started to subside. I feel like my back is bruised like I had been in a car accident.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Cardiac arrest, Chest X-ray normal, Death, Fibrin D dimer increased, Myocardial necrosis marker increased
Clinical narrative: Cardiac Arrest at home while in bed sleeping next to wife. Brought in to ER in Cardiac Arrest.  Coded for 20 minutes until time of death was called at 1:30am.
Age: 71.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Injection site bruising
Clinical narrative: Patient developed a large bruised area at the site where his Fluzone HD vaccination was given.  Patient received both Prevnar13 (high on left arm) and Fluzone HD (lower on left arm).
Age: 10.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus
Clinical narrative: 4CM round erythematous hard to touch area surrounding injection site to the left upper arm. Patient complaints of itching to the site only. No other symptoms. Did take Benadryl last night and ice pack applied today (10/30/15).
Age: 8.0
Sex: M
Vaccine: FLUN4
Symptoms: Croup infectious
Clinical narrative: CROUP WITH VISIT TO EMERGENCY ROOM.
Age: 4.0
Sex: F
Vaccine: MMR
Symptoms: Rash, Seizure like phenomena, Tremor, Urticaria
Clinical narrative: Rash--progressed to hives and shaking body movements felt to be a seizure per parent--not suppressable. Last approx. 1 minute while child "asleep" in crib.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Eye discharge, Lip swelling, Pruritus generalised
Clinical narrative: Employee described experiencing itching of palms, fingers, soles of feet, arms and back as well as "gunky" eyes and lips swelling after receiving influenza vaccine.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Body temperature increased, Chills, Rash, Rash erythematous, Rash pruritic
Clinical narrative: Friday initially elevated temperature with chills on 10/16 - TYLENOL and fluids advised. 10/19 "flaming itchy rash" on trunk and legs went to PA and took BENADRYL over the weekend - rash resolved.