chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site cellulitis, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: Patient experienced cellulitis-like reaction on the injection site. Patient's arm was red, swollen, hot and painful. The symptoms became apparent on the same day the vaccine was administered. Patient also experienced fever the arm was red from shoulder top up to elbow.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Skin warm
Clinical narrative: Patient experienced cellulitis-like reaction on the injection site. Patient's arm was red, swollen, hot and painful. The symptoms became apparent on the same day the vaccine was administered. Patient also experienced fever the arm was red from shoulder top up to elbow.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician via a company representative, refers to a male patient of unknown age. The patient's concurrent conditions, drug reactions/allergies and medical history were not reported. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX 19400 plaque forming unit (PFU) (dose, route of administration, lot number and expiration date were unknown). There were no concomitant therapies reported. The reporter stated that then, on an unknown amount of time, the patient developed shingles. No product quality complaint was involved. The outcome of herpes zoster was unknown. The causality between herpes zoster and ZOSTAVAX was not provided. Additional information is not expected because no permission to contact the physician was provided.
Age: 18.0
Sex: F
Vaccine: MENB, MENB, TDAP
Symptoms: Dizziness, Dysphagia, Dyspnoea, Nausea, Vision blurred
Clinical narrative: Approx. 11:15 am, August 10, 2016 administered BEXSERO vaccination. Within in 2 minutes, patient felt dizzy, blurred vision, shortness of breath, nauseous, and trouble swallowing. Had her sit and breathe, cold compress, water and called 911. EMT's came and monitored. After 15min pt fine, Father came and pt went home.
Age: 18.0
Sex: F
Vaccine: MENB, MENB, TDAP
Symptoms: Blood glucose normal, Dizziness, Dysphagia, Dyspnoea, Nausea
Clinical narrative: Approx. 11:15 am, August 10, 2016 administered BEXSERO vaccination. Within in 2 minutes, patient felt dizzy, blurred vision, shortness of breath, nauseous, and trouble swallowing. Had her sit and breathe, cold compress, water and called 911. EMT's came and monitored. After 15min pt fine, Father came and pt went home.
Age: 18.0
Sex: F
Vaccine: MENB, MENB, TDAP
Symptoms: Pallor
Clinical narrative: Approx. 11:15 am, August 10, 2016 administered BEXSERO vaccination. Within in 2 minutes, patient felt dizzy, blurred vision, shortness of breath, nauseous, and trouble swallowing. Had her sit and breathe, cold compress, water and called 911. EMT's came and monitored. After 15min pt fine, Father came and pt went home.
Age: 17.0
Sex: F
Vaccine: HEPA, MEN
Symptoms: Injection site erythema, Injection site nodule, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Left arm injection site is red, warm to touch, painful, swollen. Area is a 11/2 inch x 2 inch area with painful nodule palpable.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to an unspecified number of patients of unknown age and gender. Concurrent condition, medical history and concomitant therapy were not provided. On an unknown date, an unspecified number of patients received an improperly stored dose of VARIVAX (lot # M006722, expiration date 08-FEB-2018; dose and route were unknown). No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to a patient of unknown age and gender. Information regarding concomitant medication, medical history and drug reactions/allergies was not reported. On 10-MAY-2016, the patient was vaccinated with a dose of improperly stored ZOSTAVAX 19400 plague forming units (PFU) (lot # L036823 with expiration date 24-DEC-2016; dose and route were not reported). The vaccine was improperly stored at 12 degree Fahrenheit for 4 months (incorrect product storage). There was no previous temperature excursion and no data logger was involved. No adverse effect was reported. This is one of several reports received from the same reporter. 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 medical assistant referring to unspecified number of patients of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date the patients were vaccinated with improperly stored dose of GARDASIL which had lot # K011325, expiry date: 08-APR-2017 (route and dose not reported). No adverse effects were reported. No product quality complaint (PQC) involved. No further information provided. Additional information has been requested.
Sex: U
Vaccine: PNC13, PPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to a patient of unknown age. The patient's concurrent condition, medical history and concomitant therapy were unknown. On 25-JUL-2016 the patient was inadvertently vaccinated with both PNEUMOVAX 23 (lot # M005286 with expiration date: 08-OCT-2017, 0.5 ml once, intramuscular) and PREVNAR 13. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to a patient of unknown age and gender. Information regarding concomitant medication, medical history and drug reactions/allergies was not reported. On 15-MAY-2016, the patient was vaccinated with a dose of improperly stored ZOSTAVAX 19400 plaque forming units (PFU) (lot # L036823 with expiration date 24-DEC-2016; dose and route were not reported). The vaccine was improperly stored at 12 degree Fahrenheit for 4 months. There was no previous temperature excursion and no data logger was involved. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 55.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Drug hypersensitivity, Hypoaesthesia oral, Oral herpes, Psoriasis
Clinical narrative: Information has been received from a 55 year old female patient concerning herself. The patient's concurrent conditions included allergy to REGLAN. The patient's historical condition included bladder spasms. Concomitant therapies included CELEBREX, oxybutynin, SYMBICORT, EVISTA and CLARITIN. On 26-JUL-2016, the patient was vaccinated with an unspecified dose of ZOSTAVAX, frequency reported as "vaccine injection" (concentration, route, anatomical location, lot number, and expiration date were not provided), and the same day, she was also vaccinated with and unspecified dose of PNEUMOVAX23, frequency reported as "vaccine injection"(concentration, route, anatomical location, lot number, and expiration date were not provided) which was not indicated on the prescribing information (product use issue). Subsequently, on 26-JUL-2016, the patient experienced numbness in her lips and noticed a fever blister on her mouth. The patient did not seek medical attention, no laboratory studies were performed and no treatment was given for the adverse events. No product quality complaint was involved. At the time of reporting, the patient was not recovered of the numbness lips and the fever blister. The relatedness between the numbness lips and the fever blister psoriasis and the therapy ZOSTAVAX and PNEUMOVAX23 was not reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to a patient of unknown gender and age. Information regarding the patient's medical history, concurrent conditions, drug reactions/allergies and concomitant therapy were not reported. On 05-AUG-2016, the patient was inadvertently vaccinated with an expired dose of PROQUAD (lot # unspecified, expiry date: 23-JUL-2016). No adverse effects were reported. Additional information has been requested.
Sex: M
Vaccine: HPV4
Symptoms: Local swelling, Penile swelling, Skin odour abnormal
Clinical narrative: This spontaneous report was received from a male patient of unknown age regarding himself. The patient had no pertinent medical history, concurrent condition and concomitant medication. He had no previous drug reactions/allergies. On an unknown date the patient was vaccinated with GARDASIL (strength, dosing details, anatomical location, lot# and expiration date were unknown). On an unknown date, after vaccination the patient experienced swelling in the groin area. The swelling appeared in the head of the penis and had an odor. The patient sought medical attention by visiting physician's office. No treatment was received from the adverse event. Some unspecified lab diagnostic test were performed on an unknown data. The outcome of the events were unknown. Causality assessment was not provided. No product quality complaint was involved. Additional information is not expected as no reporter contact details were provided.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Patient's pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/ allergies were reported. On 13-JUL-2016, the patient was vaccinated with an expired dose of PNEUMOVAX 23 (lot # K021030, expiry date 22-JUN-2016 (strength, dosing details, anatomical location were not reported). No adverse effects were reported. No product quality complaint was involved. 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 medical assistant referring to an unspecified number of patients (ages and gender not specified). Concurrent conditions, medical history and concomitant medication use were not provided.  The medical assistant reported that the patients received unspecified doses of VARIVAX, (lot# L045954, exp. date 17-NOV-2017, lot# L041204 exp. date 20-OCT-2017, and lot# M006722, exp. date 08-FEB-2018) immunization series that were improperly stored at -13.1 C for 30 minutes between the dates of 06-JUL-2016 and 11-JUL-2016. No adverse effects were reported. The outcome of the event was not provided. Additional information has been requested.
Age: 14.0
Sex: M
Vaccine: HPV9
Symptoms: Thirst, Throat tightness
Clinical narrative: This spontaneous report as received from a nurse via a company representative refers to a 14 year old male patient. The patient's concurrent conditions included drug reactions or allergies to morphine (manufacturer unknown) and DILAUDID and also Crohn's disease. On an unknown date, the patient was vaccinated with the first dose of GARDASIL 9 (exact dose, route of administration, lot # and expiration date were not provided). On an unknown date, an unspecified time after vaccination, the patient felt thirsty and then his throat closing. The patient received EPIPEN as a treatment and he was taken to an unspecified hospital. It was reported, that the patient was at the hospital for 2 hours. The patient fully recovered on the same day. Causality assessment was not provided. Additional information is not expected because there was no consent to contact nurse.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a professional nurse referring to unspecified number of patients of unknown age and gender. Patients' pertinent medical history, drug reaction/allergies or concomitant information were not reported. On unknown dates, the patients were vaccinated with an improperly stored doses of M-M-R-II Lot # L023113 - Expiration date: 24-DEC-2016, (strength, dose and route were not provided). No symptoms were reported. The reporter stated that duration of the improperly storage was about a time frame of 3 hours, and reported temperature was 58 degrees F. The vaccines did not undergo a previous temperature excursion. There was no data logger issue reported. This is one of several reports received form the same reporter. 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 nurse referring to unknown number of patients of unknown age and gender. No information about patients' medical history, concurrent conditions and concomitant medications was not reported. On an unknown date on or after 05-APR-2016, the patients were vaccinated with improperly stored doses with PROQUAD which had lot # L033692, expiry date: 28-FEB-2017 (dose and route not reported). The vaccine was exposed to temperature of 7 degree Fahrenheit for 20 minutes. No previous temperature excursion was reported. The temperature excursion were detected by a data logger. Additionally, no adverse effects were reported and no product quality complaint (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a multiple unspecified patients of unknown demographics. On an unspecified dates, the patients received either GARDASIL with confirmed lot# L040460 and expiration date 27-MAY-2017; or GARDASIL 9 with confirmed lot#L026602 and expiration date 19-OCT-2017 (dosing details unspecified) that were improperly stored. No adverse effects reported. No product complaints involved. No further information was provided. 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 nurse referring to unknown number of patients of unknown age and gender. No information about the patients' medical history, concurrent conditions and concomitant medications was reported. On an unknown date on or after 05-APR-2016, the patients were vaccinated with improperly stored doses of VAQTA which had lot #L043209, expiry date: 17-SEP-2017 (dose and route not reported). The vaccine was exposed to temperature of 34 degree Fahrenheit for 3 hours. No previous temperature excursion was reported. The temperature excursions were detected by a data logger. Additionally, no adverse effects were reported and no product quality complaint (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse referring to unknown number of patients of unknown age and gender. No information about the patients' medical history, concurrent conditions and concomitant medications was reported. On an unknown date on or after 05-APR-2016, the patients were vaccinated with improperly stored doses of VARIVAX which had lot # K010440, expiry date: 22-JUL-2016 (dose and route not reported). The vaccine was exposed to temperature of 7 degree Fahrenheit for 20 minutes. No previous temperature excursion was reported. The temperature excursions were detected by a data logger. Additionally, no adverse effects were reported and no product quality complaint (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse referring to unknown number of patients of unknown age and gender. No information about patients' medical history, concurrent conditions and concomitant medications was reported. On an unknown date on or after 05-APR-2016, the patients were vaccinated with improperly stored doses of PEDVAXHIB which had lot # L036685, expiry date: 12-AUG-2016 (dose and route not reported). The vaccine was exposed to temperature of 34 degree Fahrenheit for 3 hours. No previous temperature excursion was reported. The temperature excursions were detected by a data logger. Additionally, no adverse effects were reported and no product quality complaint (PQC) was involved. Additional information ahs been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician referring to 5 patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant medication were unknown. On an unknown date, the patients were vaccinated with improperly stored VARIVAX (dose and frequency unknown, lot# L03015, expiration date: 11-AUG-2017). No adverse symptoms were reported. 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 nurse referring to unknown number of patients of unknown age and gender. No information about patients' medical history, concurrent conditions and concomitant medications was reported. On an unknown date on of after 05-APR-2016, the patients were vaccinated with improperly stored doses of GARDASIL which had Lot # K008931, expiry date: 04-MAR-2016 (dose and route not reported). The vaccine was exposed to temperature of 34 degree Fahrenheit for 3 hours. No previous temperature excursion was reported. The temperature excursions were detected by a data logger. Additionally, no adverse effects were reported and no product quality complaint (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Vomiting
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse via company representative regarding multiple patients of unknown demographics. Information on pertinent medical history, drug reactions/allergies and concomitant medications was not reported. On multiple unspecified dates, the patients received ROTATEQ orally (dose, frequency, lot# and expiry dates were not reported). The nurse reported that since the start (1 or 2 years ago) of ROTATEQ, it was noticed that many patients either spit up or vomit after receiving the vaccine. No other adverse effects were reported. Outcome and causality of the events were not reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On an unspecified date in 2009, the patient was vaccinated with a dose of GARDASIL (dose, lot#, expiration date and route not reported). On an unspecified date in July 2016, the patient was vaccinated with a dose of GARDASIL 9 (dose, lot#, expiration date and route not reported). No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. The patient's medical history was not reported. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # L038503, expiration date reported as 18-DEC-2017, lot #M005714, expiration date reported as 03-OCT-2017 (dose, route and site of administration were not reported) 4 doses were administered. There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 34 degrees Fahrenheit for 160 minutes. Data logger was involved. There were no previous excursions reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received on 15-JUL-2016 from a registered nurse. The registered nurse reported that on unknown dates, multiple patients (ages and gender unknown) were vaccinated with improperly stored GARDASIL 9 lot # M003659 expiration date 20-SEP-2017, LIQUID PEDVAXHIB lot # L051124 expiration date 14-OCT-2018 and M-M-R II lot # L036851 expiration date 23-SEP-2017. The temperature excursion information included the highest temperature of 53.2 degrees Fahrenheit for 30 minutes. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a professional nurse referring to unspecified number of patients of unknown age and gender. Patient's pertinent medical history, drug reaction/allergies or concomitant information were not reported. On unknown dates, the patients were vaccinated with an improperly stored doses of PNEUMOVAX23 lot # L003227 - Expiration date: 13-OCT-2016 (strength, dose and route were not provided). No symptoms were reported. The reporter stated that duration of the improperly storage was about a time frame of 3 hours, and reported temperature was 58 degrees F. The vaccines did not undergo a previous temperature excursion. There was no data logger issue reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ, MENB, MNQ
Symptoms: Back pain, Dyspnoea, Muscular weakness, Pain in extremity
Clinical narrative: Patient could wake up the next morning, she had pain in both legs from the waist to the toes.  She also had a headache and dizziness for four days.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ, MENB, MNQ
Symptoms: Dizziness, Headache, Pain in extremity
Clinical narrative: Patient could wake up the next morning, she had pain in both legs from the waist to the toes.  She also had a headache and dizziness for four days.
Age: 16.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Blood test, Computerised tomogram, Crying, Headache, Hypoaesthesia
Clinical narrative: This is a spontaneous report from a contactable physician via a Pfizer sales representative. A 16-year-old female patient of an unspecified ethnicity received the 1st dose of TRUMENBA on 23Mar2016 10:45 (lot #M37314; exp: 30Apr2017) and the 2nd dose on 21Jun2016 09:30am (Lot#M37314; Exp: 30Apr2017), both doses IM at 0.5ml left deltoid. The patient medical history included: she was an adopted child-neonatal period complicated with drug withdrawal, congenital ongoing nystagmus evaluated by ophthalmology in first few months after birth. The concomitant medications included MENACTRA (Sanofi Pasteur, Lot#: 45185BA) IM in left deltoid at single dose on the same date (not specified one) of TRUMENBA. She experienced paresthesia of left foot (dorsum) x2 week prior to 2nd dose of Men B vaccination and 2 and a 1/2 months later started to have numbness in the left foot. In Jun2016, after both vaccinations, the patient experienced headaches as well as numbness, pain and weakness on left side of body. Numbness spread rapidly to left side of body with weakness of left upper lower limb. Events were reported only after 2nd episode occurred. The AEs required an emergency room or physician visit: ER management for 6 hrs. A scan was performed on an unknown date, and no results available. The outcome of the events was unknown. In ER - CT brain was normal. Blood has showed low magnesium - replaced. She was discharge home with diagnosis of atypical migraine. Referred to neurologist in Jul2016. The nurse stated that the patient provide to him/her information regarding the reported adverse events with the use of the suspect. The nurse considered there was not a reasonable possibility that the event is related to suspect product. The reporter was willing to be contacted again by Pfizer on the reported adverse events. Follow-up attempts completed. No further information expected. Follow-up (02Aug2016): New information reported from a contactable Nurse included: vaccination date for 1st dose; administration route; vaccination time; Batch/Lot # and expiration date; concomitant medications; lab tests; medical history; events onset date; emergency room visit required; events outcome, reporter informed regarding the adverse events; reporter event causality assessment; reporter further contactability.
Age: 16.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Influenza, Mobility decreased, Neck pain, Pain, Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable physician via a Pfizer sales representative. A 16-year-old female patient of an unspecified ethnicity received the 1st dose of TRUMENBA on 23Mar2016 10:45 (lot #M37314; exp: 30Apr2017) and the 2nd dose on 21Jun2016 09:30am (Lot#M37314; Exp: 30Apr2017), both doses IM at 0.5ml left deltoid. The patient medical history included: she was an adopted child-neonatal period complicated with drug withdrawal, congenital ongoing nystagmus evaluated by ophthalmology in first few months after birth. The concomitant medications included MENACTRA (Sanofi Pasteur, Lot#: 45185BA) IM in left deltoid at single dose on the same date (not specified one) of TRUMENBA. She experienced paresthesia of left foot (dorsum) x2 week prior to 2nd dose of Men B vaccination and 2 and a 1/2 months later started to have numbness in the left foot. In Jun2016, after both vaccinations, the patient experienced headaches as well as numbness, pain and weakness on left side of body. Numbness spread rapidly to left side of body with weakness of left upper lower limb. Events were reported only after 2nd episode occurred. The AEs required an emergency room or physician visit: ER management for 6 hrs. A scan was performed on an unknown date, and no results available. The outcome of the events was unknown. In ER - CT brain was normal. Blood has showed low magnesium - replaced. She was discharge home with diagnosis of atypical migraine. Referred to neurologist in Jul2016. The nurse stated that the patient provide to him/her information regarding the reported adverse events with the use of the suspect. The nurse considered there was not a reasonable possibility that the event is related to suspect product. The reporter was willing to be contacted again by Pfizer on the reported adverse events. Follow-up attempts completed. No further information expected. Follow-up (02Aug2016): New information reported from a contactable Nurse included: vaccination date for 1st dose; administration route; vaccination time; Batch/Lot # and expiration date; concomitant medications; lab tests; medical history; events onset date; emergency room visit required; events outcome, reporter informed regarding the adverse events; reporter event causality assessment; reporter further contactability.
Age: 16.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Pain in jaw, Screaming, Spinal pain
Clinical narrative: This is a spontaneous report from a contactable physician via a Pfizer sales representative. A 16-year-old female patient of an unspecified ethnicity received the 1st dose of TRUMENBA on 23Mar2016 10:45 (lot #M37314; exp: 30Apr2017) and the 2nd dose on 21Jun2016 09:30am (Lot#M37314; Exp: 30Apr2017), both doses IM at 0.5ml left deltoid. The patient medical history included: she was an adopted child-neonatal period complicated with drug withdrawal, congenital ongoing nystagmus evaluated by ophthalmology in first few months after birth. The concomitant medications included MENACTRA (Sanofi Pasteur, Lot#: 45185BA) IM in left deltoid at single dose on the same date (not specified one) of TRUMENBA. She experienced paresthesia of left foot (dorsum) x2 week prior to 2nd dose of Men B vaccination and 2 and a 1/2 months later started to have numbness in the left foot. In Jun2016, after both vaccinations, the patient experienced headaches as well as numbness, pain and weakness on left side of body. Numbness spread rapidly to left side of body with weakness of left upper lower limb. Events were reported only after 2nd episode occurred. The AEs required an emergency room or physician visit: ER management for 6 hrs. A scan was performed on an unknown date, and no results available. The outcome of the events was unknown. In ER - CT brain was normal. Blood has showed low magnesium - replaced. She was discharge home with diagnosis of atypical migraine. Referred to neurologist in Jul2016. The nurse stated that the patient provide to him/her information regarding the reported adverse events with the use of the suspect. The nurse considered there was not a reasonable possibility that the event is related to suspect product. The reporter was willing to be contacted again by Pfizer on the reported adverse events. Follow-up attempts completed. No further information expected. Follow-up (02Aug2016): New information reported from a contactable Nurse included: vaccination date for 1st dose; administration route; vaccination time; Batch/Lot # and expiration date; concomitant medications; lab tests; medical history; events onset date; emergency room visit required; events outcome, reporter informed regarding the adverse events; reporter event causality assessment; reporter further contactability.
Age: 16.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Blood magnesium decreased, Blood test, Computerised tomogram head normal, Condition aggravated, Headache
Clinical narrative: This is a spontaneous report from a contactable physician via a Pfizer sales representative. A 16-year-old female patient of an unspecified ethnicity received the 1st dose of TRUMENBA on 23Mar2016 10:45 (lot #M37314; exp: 30Apr2017) and the 2nd dose on 21Jun2016 09:30am (Lot#M37314; Exp: 30Apr2017), both doses IM at 0.5ml left deltoid. The patient medical history included: she was an adopted child-neonatal period complicated with drug withdrawal, congenital ongoing nystagmus evaluated by ophthalmology in first few months after birth. The concomitant medications included MENACTRA (Sanofi Pasteur, Lot#: 45185BA) IM in left deltoid at single dose on the same date (not specified one) of TRUMENBA. She experienced paresthesia of left foot (dorsum) x2 week prior to 2nd dose of Men B vaccination and 2 and a 1/2 months later started to have numbness in the left foot. In Jun2016, after both vaccinations, the patient experienced headaches as well as numbness, pain and weakness on left side of body. Numbness spread rapidly to left side of body with weakness of left upper lower limb. Events were reported only after 2nd episode occurred. The AEs required an emergency room or physician visit: ER management for 6 hrs. A scan was performed on an unknown date, and no results available. The outcome of the events was unknown. In ER - CT brain was normal. Blood has showed low magnesium - replaced. She was discharge home with diagnosis of atypical migraine. Referred to neurologist in Jul2016. The nurse stated that the patient provide to him/her information regarding the reported adverse events with the use of the suspect. The nurse considered there was not a reasonable possibility that the event is related to suspect product. The reporter was willing to be contacted again by Pfizer on the reported adverse events. Follow-up attempts completed. No further information expected. Follow-up (02Aug2016): New information reported from a contactable Nurse included: vaccination date for 1st dose; administration route; vaccination time; Batch/Lot # and expiration date; concomitant medications; lab tests; medical history; events onset date; emergency room visit required; events outcome, reporter informed regarding the adverse events; reporter event causality assessment; reporter further contactability.
Age: 16.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Hemiparesis, Hypoaesthesia, Migraine, Muscular weakness, Pain
Clinical narrative: This is a spontaneous report from a contactable physician via a Pfizer sales representative. A 16-year-old female patient of an unspecified ethnicity received the 1st dose of TRUMENBA on 23Mar2016 10:45 (lot #M37314; exp: 30Apr2017) and the 2nd dose on 21Jun2016 09:30am (Lot#M37314; Exp: 30Apr2017), both doses IM at 0.5ml left deltoid. The patient medical history included: she was an adopted child-neonatal period complicated with drug withdrawal, congenital ongoing nystagmus evaluated by ophthalmology in first few months after birth. The concomitant medications included MENACTRA (Sanofi Pasteur, Lot#: 45185BA) IM in left deltoid at single dose on the same date (not specified one) of TRUMENBA. She experienced paresthesia of left foot (dorsum) x2 week prior to 2nd dose of Men B vaccination and 2 and a 1/2 months later started to have numbness in the left foot. In Jun2016, after both vaccinations, the patient experienced headaches as well as numbness, pain and weakness on left side of body. Numbness spread rapidly to left side of body with weakness of left upper lower limb. Events were reported only after 2nd episode occurred. The AEs required an emergency room or physician visit: ER management for 6 hrs. A scan was performed on an unknown date, and no results available. The outcome of the events was unknown. In ER - CT brain was normal. Blood has showed low magnesium - replaced. She was discharge home with diagnosis of atypical migraine. Referred to neurologist in Jul2016. The nurse stated that the patient provide to him/her information regarding the reported adverse events with the use of the suspect. The nurse considered there was not a reasonable possibility that the event is related to suspect product. The reporter was willing to be contacted again by Pfizer on the reported adverse events. Follow-up attempts completed. No further information expected. Follow-up (02Aug2016): New information reported from a contactable Nurse included: vaccination date for 1st dose; administration route; vaccination time; Batch/Lot # and expiration date; concomitant medications; lab tests; medical history; events onset date; emergency room visit required; events outcome, reporter informed regarding the adverse events; reporter event causality assessment; reporter further contactability.
Age: 16.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Paraesthesia, Scan
Clinical narrative: This is a spontaneous report from a contactable physician via a Pfizer sales representative. A 16-year-old female patient of an unspecified ethnicity received the 1st dose of TRUMENBA on 23Mar2016 10:45 (lot #M37314; exp: 30Apr2017) and the 2nd dose on 21Jun2016 09:30am (Lot#M37314; Exp: 30Apr2017), both doses IM at 0.5ml left deltoid. The patient medical history included: she was an adopted child-neonatal period complicated with drug withdrawal, congenital ongoing nystagmus evaluated by ophthalmology in first few months after birth. The concomitant medications included MENACTRA (Sanofi Pasteur, Lot#: 45185BA) IM in left deltoid at single dose on the same date (not specified one) of TRUMENBA. She experienced paresthesia of left foot (dorsum) x2 week prior to 2nd dose of Men B vaccination and 2 and a 1/2 months later started to have numbness in the left foot. In Jun2016, after both vaccinations, the patient experienced headaches as well as numbness, pain and weakness on left side of body. Numbness spread rapidly to left side of body with weakness of left upper lower limb. Events were reported only after 2nd episode occurred. The AEs required an emergency room or physician visit: ER management for 6 hrs. A scan was performed on an unknown date, and no results available. The outcome of the events was unknown. In ER - CT brain was normal. Blood has showed low magnesium - replaced. She was discharge home with diagnosis of atypical migraine. Referred to neurologist in Jul2016. The nurse stated that the patient provide to him/her information regarding the reported adverse events with the use of the suspect. The nurse considered there was not a reasonable possibility that the event is related to suspect product. The reporter was willing to be contacted again by Pfizer on the reported adverse events. Follow-up attempts completed. No further information expected. Follow-up (02Aug2016): New information reported from a contactable Nurse included: vaccination date for 1st dose; administration route; vaccination time; Batch/Lot # and expiration date; concomitant medications; lab tests; medical history; events onset date; emergency room visit required; events outcome, reporter informed regarding the adverse events; reporter event causality assessment; reporter further contactability.
Age: 17.0
Sex: F
Vaccine: MENB, MNQ, MENB
Symptoms: Dizziness, Erythema, Heart rate increased, Nausea, Ocular hyperaemia
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of fever in a female patient who received BEXSERO. On an unknown date, the patient received BEXSERO (intramuscular). On unknown date, 4 hrs after receiving BEXSERO, the patient experienced fever, headache, heart rate increased, bloodshot eye and injection site pain. On an unknown date, the outcome of the fever, headache, heart rate increased, bloodshot eye and injection site pain were unknown. The reporter considered the fever, headache, heart rate increased, bloodshot eye and injection site pain to be probably related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, the 16 to 18 years old patient experienced fever (103 degree F), bloodshot eyes, headache, increased heart rate and pain at injection site. The reporter will be on vacation and correspondence contact (practice manager) was reported. This case is one of the four cases reported by the same reporter.
Age: 17.0
Sex: F
Vaccine: MENB, MNQ, MENB
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of fever in a female patient who received BEXSERO. On an unknown date, the patient received BEXSERO (intramuscular). On unknown date, 4 hrs after receiving BEXSERO, the patient experienced fever, headache, heart rate increased, bloodshot eye and injection site pain. On an unknown date, the outcome of the fever, headache, heart rate increased, bloodshot eye and injection site pain were unknown. The reporter considered the fever, headache, heart rate increased, bloodshot eye and injection site pain to be probably related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, the 16 to 18 years old patient experienced fever (103 degree F), bloodshot eyes, headache, increased heart rate and pain at injection site. The reporter will be on vacation and correspondence contact (practice manager) was reported. This case is one of the four cases reported by the same reporter.
Age: 17.0
Sex: F
Vaccine: MENB, MNQ, MENB
Symptoms: Headache, Heart rate increased, Injection site pain, Ocular hyperaemia, Pyrexia
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of fever in a female patient who received BEXSERO. On an unknown date, the patient received BEXSERO (intramuscular). On unknown date, 4 hrs after receiving BEXSERO, the patient experienced fever, headache, heart rate increased, bloodshot eye and injection site pain. On an unknown date, the outcome of the fever, headache, heart rate increased, bloodshot eye and injection site pain were unknown. The reporter considered the fever, headache, heart rate increased, bloodshot eye and injection site pain to be probably related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, the 16 to 18 years old patient experienced fever (103 degree F), bloodshot eyes, headache, increased heart rate and pain at injection site. The reporter will be on vacation and correspondence contact (practice manager) was reported. This case is one of the four cases reported by the same reporter.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PPV, PPV
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a licensed practical nurse (also the patient's mother) referring to a 2 month old female patient. The patient's medical history, concurrent condition and concomitant medication were reported as none. On 13-JUN-2006, the patient was inadvertently vaccinated with a dose of PNEUMOVAX 23 (strength, lot#, expiration date, dose and route were not reported). On an unspecified date in February 2008, the patient was seen by an unspecified pediatric orthopedic surgeon and diagnosed with "Trigger Finger". The patient had a "Trigger Finger Release" surgery performed on an unspecified date in August 2008. X-rays were performed on unknown dates (results not reported). The reporting nurse stated that the patient was recovered about 6-8 weeks after the surgery was performed. The relatedness between trigger finger and trigger finger release surgery and PNEUMOVAX 23 was not reported. Upon internal review, trigger finger was considered to be medically significant. Additional information has been requested.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PPV, PPV
Symptoms: Tendon sheath incision, Trigger finger, X-ray
Clinical narrative: Information has been received from a licensed practical nurse (also the patient's mother) referring to a 2 month old female patient. The patient's medical history, concurrent condition and concomitant medication were reported as none. On 13-JUN-2006, the patient was inadvertently vaccinated with a dose of PNEUMOVAX 23 (strength, lot#, expiration date, dose and route were not reported). On an unspecified date in February 2008, the patient was seen by an unspecified pediatric orthopedic surgeon and diagnosed with "Trigger Finger". The patient had a "Trigger Finger Release" surgery performed on an unspecified date in August 2008. X-rays were performed on unknown dates (results not reported). The reporting nurse stated that the patient was recovered about 6-8 weeks after the surgery was performed. The relatedness between trigger finger and trigger finger release surgery and PNEUMOVAX 23 was not reported. Upon internal review, trigger finger was considered to be medically significant. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HEP, PNC13
Symptoms: Wrong drug administered
Clinical narrative: No adverse event.  Prevnar 13 was given instead of Pneumovax 23.
Age: 12.0
Sex: M
Vaccine: HPV4
Symptoms: Cerebrovascular accident, Dehydration, Electroencephalogram, Fatigue, Feeling abnormal
Clinical narrative: Continual migraine, taken to hospital for stroke like symptoms, dehydration, sensitivity to light, muscle pain and fatigue, brain fog.
Age: 12.0
Sex: M
Vaccine: HPV4
Symptoms: Migraine, Myalgia, Photophobia
Clinical narrative: Continual migraine, taken to hospital for stroke like symptoms, dehydration, sensitivity to light, muscle pain and fatigue, brain fog.
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV, MMR, VARCEL
Symptoms: Crying, Erythema, Eye disorder, Food allergy, Insomnia
Clinical narrative: After many of his shots he had fever, rashes, sleepless nights, staring scenes, shaking or going into shock, days he doesn't talk, etc. I have talk to doctors but it's hard trusting the work they do.
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV, MMR, VARCEL
Symptoms: Psychomotor hyperactivity, Pyrexia, Rash, Screaming, Seizure
Clinical narrative: After many of his shots he had fever, rashes, sleepless nights, staring scenes, shaking or going into shock, days he doesn't talk, etc. I have talk to doctors but it's hard trusting the work they do.
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV, MMR, VARCEL
Symptoms: Shock, Speech disorder, Staring, Swelling, Tremor
Clinical narrative: After many of his shots he had fever, rashes, sleepless nights, staring scenes, shaking or going into shock, days he doesn't talk, etc. I have talk to doctors but it's hard trusting the work they do.
Age: 63.0
Sex: M
Vaccine: PPV
Symptoms: Dizziness
Clinical narrative: Dizziness, lightheaded.  Worsening over the past 48 hours. No fever or chills.
Sex: U
Vaccine: FLUX, TTOX
Symptoms: Allergy to vaccine
Clinical narrative: Initial unsolicited report received from a physician via other company (Pfizer) (Manufacturer Report Number: 2016344812) on 01-Aug-2016. This case involves a patient (age and gender was not reported) who was vaccinated with a dose of TETANUS TOXOID and INFLUENZA VACCINE (batch number, expiration date, dose, dose in series, route and site of administration were not reported for both) on an unspecified date. Patient's medical history and concomitant medications were not reported. On an unspecified date, following vaccination, the patient developed allergy to Tetanus and Influenza Vaccine. Laboratory investigations and corrective treatment were not reported. The outcome of the event was not reported. List of documents held by sender: none.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site urticaria, Swollen tongue, Urticaria
Clinical narrative: Initial unsolicited report received from a nurse on 04 August 2016. This case involves a 17-year-old female patient who was vaccinated with a second dose of MENACTRA (batch number: U5244AA, expiry date 01 May 2017, dose, route of administration were not reported) in right deltoid on 02 August 2016. Illness at time of vaccination was reported as none and pre-existing physician diagnosed allergies, birth defects, medical conditions was reported as no known allergies and none. Concomitant medications were reported as none. On 02 August 2016, same day following the vaccination, in the evening patient developed hives starting at the injection site and progressing to full body hives and experienced tongue swelling. It was reported that patient was taken to emergency department. Patient required emergency room or doctor visit. Lab data was reported as none. Patient received corrective treatment with Intravenous Benadryl and Medrol. On unspecified date, patient recovered from events. List of documents held by sender: none.
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Headache, Injection site rash, Malaise, Musculoskeletal pain, Pain in extremity
Clinical narrative: Rash leading from injection site to arm pit area, painful shoulder and arm, fever, headache, general malaise, and vertigo.
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia, Rash, Vertigo
Clinical narrative: Rash leading from injection site to arm pit area, painful shoulder and arm, fever, headache, general malaise, and vertigo.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Blood calcium decreased, Blood electrolytes, Dizziness, Ear irrigation, Full blood count normal
Clinical narrative: Pt had fasted that morning, received Tdap and MENACTRA vaccine, had ear irrigated for a foreign body and at completion of irrigation had sudden onset severe headache, dizziness, nausea, vomiting, pallor, BP 80/44. Pt transferred to ER where symptoms self resolved and felt could have been secondary to ear wash.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Headache, Nausea, Pallor, Vomiting
Clinical narrative: Pt had fasted that morning, received Tdap and MENACTRA vaccine, had ear irrigated for a foreign body and at completion of irrigation had sudden onset severe headache, dizziness, nausea, vomiting, pallor, BP 80/44. Pt transferred to ER where symptoms self resolved and felt could have been secondary to ear wash.
Age: 17.0
Sex: F
Vaccine: FLU3, MENB, MNQ, FLU3, MENB, MNQ, MNQ
Symptoms: Erythema, Headache, Injection site erythema, Pain in extremity, Pruritus
Clinical narrative: Fever, rash headache, itching, pain in the arm, redness on the site of the vaccine administration (right arm) and redness in the left arm.
Age: 17.0
Sex: F
Vaccine: FLU3, MENB, MNQ, FLU3, MENB, MNQ, MNQ
Symptoms: Pyrexia, Rash
Clinical narrative: Fever, rash headache, itching, pain in the arm, redness on the site of the vaccine administration (right arm) and redness in the left arm.