chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 11.0
Sex: F
Vaccine: FLU4, HPV9, MNQ, TDAP
Symptoms: Thyroid disorder, Vomiting
Clinical narrative: Joint pain all over body, throwing up, headache, eye sensitivity, rashes, stomach issues, numbness around joints, memory loss.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Balance disorder, Fall, Feeling abnormal, Loss of consciousness, Muscle twitching
Clinical narrative: Approximately 5 minutes after receiving the vaccine, patient tried to stand up, mother noticed that he looked unsteady, he started to fall, mother caught him, he had a few seconds of twitching, and seemed to pass out. Was conscious after a few seconds.  Seemed dazed, but was responsive and oriented.   vital sign were normal. Patient had some juice, crackers, and water. Was monitored in clinic x 20 more minutes, then felt fine.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Vaccination complication
Clinical narrative: Pt presented to the ER complaining of swelling and a warm red area around the injection site. ER did not seem to think was infected but was an adverse reaction to vaccine. In case of cellulitis prescribed Doxycycline twice daily for 10 days. Patient did not show reaction to pharmacist so that we could determine if typical reaction.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Contusion, Immediate post-injection reaction, Swelling
Clinical narrative: Immediate swelling. Next day bruising that lasted x2 wks.
Age: 2.0
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Gait disturbance, Injection site irritation, Injection site pain, Injection site swelling
Clinical narrative: Swelling of L leg 2d prior to vaccines. Some painful but had a little limp. Scratching of the area.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Eating disorder, Muscle twitching, Musculoskeletal stiffness, Otitis media, Pyrexia
Clinical narrative: Fever 101.5 starting 08/15/17, stiffening of arms and legs for appox 2 minutes. Sent to ED for evaluation. 8/16/17 not eating well and low grade fever 100.2. Had 2nd seizure with tonic and twitching movements. Diagnosed with otitis media at clinic. Referral to neurology 8/19/17 3rd seizure -now afebrile. Seizure last night about 20 secs.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Seizure, Tonic convulsion
Clinical narrative: Fever 101.5 starting 08/15/17, stiffening of arms and legs for appox 2 minutes. Sent to ED for evaluation. 8/16/17 not eating well and low grade fever 100.2. Had 2nd seizure with tonic and twitching movements. Diagnosed with otitis media at clinic. Referral to neurology 8/19/17 3rd seizure -now afebrile. Seizure last night about 20 secs.
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Hyperhidrosis, Nausea
Clinical narrative: Nausea, sweats, light-headedness last about 48 hours.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Biopsy skin, Urticaria
Clinical narrative: Next day hives all over body.
Age: 52.0
Sex: F
Vaccine: VARCEL
Symptoms: Cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: 2 days after varicella injection developed swelling and redness at injection site and from shoulder to elbow. Seen by ER provider. Dx = cellulitis.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling 4 x 3 inch around injection site.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site warmth, Pyrexia
Clinical narrative: Fever on 8/23/17, but it ended 8/24/17 redness at injection site, warm to the touch.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Pyrexia, Seizure
Clinical narrative: Pt experienced fever and seizure day after vaccine administration.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Gaze palsy, Muscle tightness
Clinical narrative: 5 seconds of body/muscle tightening with eyes roll upward. Back at baseline after. Monitored BP for 15 min and NML, exam NML also. Pt. Hx syncope.
Age: 1.33
Sex: F
Vaccine: DTAPIPVHIB, VARCEL
Symptoms: Erythema, Limb mass, Skin warm, Swelling
Clinical narrative: Mom noticed on 8/24/17 evening. She had a small lump on the outside (Lt) thigh. On 8/25/17 the lump was as big as a 50 cent piece an red/swollen and warm to touch. No fever.
Age: 1.33
Sex: M
Vaccine: DTAPIPVHIB, VARCEL
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Received PENTACEL 8/23/17. On 8/25/17 Mom said was red when she took him to daycare. When she picked him up the right thigh was very swollen/red and hot touch. (F 100 - 101 degrees). Given antihistamines.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Mass, Pain in extremity, Soft tissue swelling
Clinical narrative: Patient had a swollen tissue at upper arm pit towards breast side. It was a walnut-size. Initially patient had arm soreness but got a little better. But swelling/lump like is still there. She got shot on 8/25/17, on 8/27/17 morning she noticed the swelling.
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Cellulitis, Erythema, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: (L) arm red, swollen and warm to touch and painful. Dx: Cellulitis. Rx'd KEFLEX 250 mg/5 ml - take 10 ml 3x day apply cool compress.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Loss of personal independence in daily activities, Mobility decreased, Pain in extremity
Clinical narrative: Righ after I got the shot I could not lift my arm above my shoulder. I could not reach to the opposite side of my back. I could not put my hair in a pony tail, I could not reach up to turn on the light switch. I thought it was gonna get better but it's not the pain is still there. I told the doctor about it, and he gave me some exercises to do. It helped some ut the pain is still there.
Age: 61.0
Sex: M
Vaccine: FLUC4, PPV
Symptoms: Chills, Injected limb mobility decreased, Injection site pain
Clinical narrative: Pt complained of chills lasting several hours while he slept. Pt complains of arm very sore at injection site and difficulty moving arm. Said today it is somewhat less painful.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Pyrexia, Swelling
Clinical narrative: 08/26/17 6 pm reported fever, swelling, redness; 08/27/17 11 am fever resolved, still swollen and red; 08/27/17 9 am ER visit, treatment with prednisone and resolved.
Age: 12.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Blood glucose increased, Gait disturbance, Hypotension, Pallor, Staring
Clinical narrative: Within few minutes after receiving vaccines became ache - helped lay on floor with feet in chair. Became verbally unresponsive with staring episodes - ammonia capsule with immediate, but short lived results. No change after 5 minutes. Epinephrine administered IM - no change in next 5 minutes. EMS assessment - hypotensive and elevated blood sugar refused to go to ER. Home with unsteady gait - returned to school - 2 days later with no medical evaluation. Mom reported swelling developed next day - HPV.
Age: 12.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Swelling, Unresponsive to stimuli
Clinical narrative: Within few minutes after receiving vaccines became ache - helped lay on floor with feet in chair. Became verbally unresponsive with staring episodes - ammonia capsule with immediate, but short lived results. No change after 5 minutes. Epinephrine administered IM - no change in next 5 minutes. EMS assessment - hypotensive and elevated blood sugar refused to go to ER. Home with unsteady gait - returned to school - 2 days later with no medical evaluation. Mom reported swelling developed next day - HPV.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Wheezing
Clinical narrative: Patient reported wheezing symptoms which didn't start until 24 hours after administration of ZOSTAVAX. RPH recommended consulting with doctor ASAP. Patient said wheezing symptoms might also be due to gardening done today, but she wasn't sure.
Age: 11.0
Sex: F
Vaccine: HPV2, MNQ, TDAP
Symptoms: Urticaria
Clinical narrative: After administration of vaccines, pt develop hives. Doctor of the day came and treat pt with ZYRTEC 10 mg and send them to ER for observation.
Age: 13.0
Sex: F
Vaccine: HEPA
Symptoms: Incorrect dose administered
Clinical narrative: Patient was given an adult vaccine Hep A vaccine adult dose given to pediatric patient. Double the dose for age.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Pain, Pyrexia, Restlessness, Swelling
Clinical narrative: Swelling and redness started the same night. It covered from shoulder to elbow. Fever of 102 degrees for 2 days. Received doxycycline - redness has diminished but is still very painful. Patient stated he always gets fever and feels ill after flu shots. Patient also stated when he got the PREVNAR 13 vaccine in 8/2016 he felt ill with fever and aches for 7 days after vaccination.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Cellulitis, Erythema, Skin warm, Swelling
Clinical narrative: Experienced redness, swelling and arm was warm to the touch. This occurred 60 hours after the injection. Went to the clinic at 3PM on 8-26-17 and diagnosed with cellulitis. Prescribed Cephalexin 500 mg QID x 7 days.
Age: 76.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: This spontaneous report has been received from a pharmacist referring to a 76 year old female patient. Concomitant medication included unspecified Statin. The patient's drug reactions/allergies and medical history were unknown. On 26-JUL-2017, the patient was vaccinated with PNEUMOVAX 23 lot # M029681, expiration date 22-JAN-2018 (dose not reported), intramuscularly (IM) to prevent pneumonia. On 27-JUL-2017, the patient noticed a "large, red, raised, painful area" on the same arm as injection site but above elbow and not near injection site. The patient received treatment and was feeling better at the time of report. The causality between the events and PNEUMOVAX 23 was not provided. This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-1708USA006803:
Age: 76.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report has been received from a pharmacist referring to a 76 year old female patient. Concomitant medication included unspecified Statin. The patient's drug reactions/allergies and medical history were unknown. On 26-JUL-2017, the patient was vaccinated with PNEUMOVAX 23 lot # M029681, expiration date 22-JAN-2018 (dose not reported), intramuscularly (IM) to prevent pneumonia. On 27-JUL-2017, the patient noticed a "large, red, raised, painful area" on the same arm as injection site but above elbow and not near injection site. The patient received treatment and was feeling better at the time of report. The causality between the events and PNEUMOVAX 23 was not provided. This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-1708USA006803:
Age: 69.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Erythema, Inflammation, Pain, Skin warm, Swelling
Clinical narrative: This spontaneous report has been received from a pharmacist referring to a 69 year old female patient. The patient was allergic to penicillin (PCN) and macrolide. Concomitant medication and medical history were unknown. On 26-JUL-2017, the patient was vaccinated with PNEUMOVAX 23 lot # M029681, expiration date 22-JAN-2018 (dose not reported), intramuscularly (IM) to prevent pneumonia. On 27-JUL-2017, the patient noticed a" large, red, raised, painful area" on the same arm as injection site but above elbow and not near injection site. The patient received treatment and did not seek medical attention. The outcome of the events was unknown at the time of report. The causality between the events and PNEUMOVAX 23 was not provided. This is one of two reports received from the same reporter.; Sender's Comments: US-009507513-1707USA013341:
Age: 69.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report has been received from a pharmacist referring to a 69 year old female patient. The patient was allergic to penicillin (PCN) and macrolide. Concomitant medication and medical history were unknown. On 26-JUL-2017, the patient was vaccinated with PNEUMOVAX 23 lot # M029681, expiration date 22-JAN-2018 (dose not reported), intramuscularly (IM) to prevent pneumonia. On 27-JUL-2017, the patient noticed a" large, red, raised, painful area" on the same arm as injection site but above elbow and not near injection site. The patient received treatment and did not seek medical attention. The outcome of the events was unknown at the time of report. The causality between the events and PNEUMOVAX 23 was not provided. This is one of two reports received from the same reporter.; Sender's Comments: US-009507513-1707USA013341:
Age: 1.42
Sex: M
Vaccine: MMRV
Symptoms: Pyrexia, Rash
Clinical narrative: Rash on torso, head, extremities and low grade fever.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Erythema, Pruritus, Rash pustular
Clinical narrative: Clear pustules (water blisters), it is itchy, redness, no pain.
Age: 5.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a medical assistant and refers to a 5-year-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical histories provided. On 13-APR-2017, the patient was vaccinated with improperly stored dose of PROQUAD lot # M041083, expiration date 04-APR-2018 (dose and route of administration were not reported). There was no adverse effect reported. Vaccine was reconstituted with properly stored sterile diluent. Administered dose of vaccine experienced the temperature excursion between 15 to 46 degrees Fahrenheit (F) (22.3 (F)) for 1 hour and 3 minutes. Digital data logger was involved. There were no previous excursions reported. No product quality complaint was involved. The reporter also stated that she had a printed report of the patients who received vaccines that had undergone the temperature excursion. The report included vaccine name, date given lot number and the name, gender and birth date of patient. This is one of several reports received from the same reporter. Additional information is not expected as all relevant correspondence has already been received. This report was previously submitted with the incorrect Worldwide unique case identification number US-009507513-1705USA005093', and this new follow-up submission is to provide the correct identification number US-009507513-1706USA003934'. US-009507513-1705USA005093' is an existing case, therefore this safety report is not being nullified, just updated to reflect correct Worldwide Unique identification number. Sender's Comments: US-009507513-1705USA005086: US-009507513-1705USA005094: US-009507513-1705USA005093: US-009507513-1706USA003935: US-009507513-1706USA003936: US-009507513-1706USA003937.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a vaccine coordinator refers to 17 unspecified patients of unknown age and gender. Information regarding relevant medical history, concurrent condition and concomitant medications were not reported. On unknown dates, the patient was vaccinated with improperly stored VARIVAX (lot # M041514, expiration date 18-OCT-2018, dose and route not reported) for prophylaxis. The VARIVAX was reconstituted with properly stored sterile diluent (MERCK). It was reported that the vaccine was stored at 6 degrees Fahrenheit to 14 degrees Fahrenheit for 20 minutes and there was no previous temperature excursion. The call was made because of a "data logger" issue. No adverse effects reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a medical assistant referring to a patient of unknown age and gender. On 22-JUL-2017, the patient administered an improperly stored dose of PROQUAD (dose, frequency and route unknown, lot # N012490, expiration date:17-OCT-2018) for prophylaxis. Other suspect therapies included sterile diluent(manufacturer unknown)(dose, frequency, route, lot # and expiration date unknown,) which was used to reconstitute improperly stored PROQUAD.  The temperature excursion was at 6 Fahrenheit degree to 14 Fahrenheit degree for 156 hours(incorrect product storage). The previous temperature excursion was 6 Fahrenheit degree to 14 Fahrenheit degree for 4 hours and 15 Fahrenheit degree to 46 Fahrenheit degree for 1 hour. Data logger was not involved. No adverse effect was reported. This case was cross referenced with case 1708USA012173; Sender's Comments: US-009507513-1708USA012173:
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site swelling, Injection site vesicles
Clinical narrative: This spontaneous report was received from a medical assistant and a healthcare business professional referring to a 77 year old female patient. The patient's concomitant medication and pertinent medical history were unknown. There was no drug allergy. On 05-JUN-2017 (also reported as 06-JUN-2017), the patient was vaccinated with a dose of PNEUMOVAX 23 (single dose, lot # M043424 and expiration date 06-JUN-2018, route and indication were unknown). Then, on 05-JUN-2017, 3 hours after administration of PNEUMOVAX 23, the patient developed swelling, redness and a lump as well as blisters and pain at injection site. Unspecified treatment was given to the patient. No lab diagnostics was performed. Therapy with PNEUMOVAX 23 was also reported as discontinued on 14-JUN-2017. At the reporting time, the patient recovered from the events. The causality between the events and PNEUMOVAX 23 was not reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a healthcare worker, concerning a patient of unknown age and gender. On 28-JUL-2017, the patient was vaccinated with VARIVAX lot # M033214 for prophylaxis instead of the intended dose of ZOSTAVAX no adverse effects were reported.
Sex: F
Vaccine: HPV4
Symptoms: Dizziness
Clinical narrative: Information has been received from a female consumer concerning her daughter of unknown age. The patient did not pregnant. The patient's concurrent condition, medical history and concomitant therapy information was not provided. In 2016 (reported as one year ago), the patient was vaccinated with the first dose of GARDASIL (1 dose, route: intramuscular) (lot#, expiration date and strength were not reported) for human papillomavirus (HPV) by an anonymous physician. On an unknown date, the patient experienced dizziness but it laid down and recovered on an unknown date. The patient did not return for the second or third dose. Causality between the event and GARDASIL was unknown.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a physician referring to an unspecified number of patients of unknown age and gender. The patients' concurrent condition, medical history and concomitant therapy were not reported. On an unspecified date, an unspecified number of patients were vaccinated with an unspecified number of separate doses of improperly stored VAQTA (lot # N005274, expiration date 03-APR-2018) (dosage, frequency and route were not reported) for prophylaxis (incorrect product storage). No adverse effects were reported. The vaccine was stored at a temperature from 32 to 35 degrees Fahrenheit for 5.5 hours. There was no previous temperature excursion. Data logger was involved. No product quality complaint was involved. No additional information was provided.
Sex: F
Vaccine: MMR, MMRV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a consumer refers to a female patient of unknown age. On 2006 the patient was vaccinated with PROQUAD lot reported as 0770R expiration date 04-AUG-2006 for prophylaxis. Other suspect therapies included M-M-R II. On an unknown date the patient experienced wrong drug administered and no adverse event. The outcome of wrong drug administered and no adverse event is unknown. The reporter considered wrong drug administered and no adverse event to be not related to M-M-R II and PROQUAD.
Sex: M
Vaccine: VARZOS
Symptoms: Rash, Rash erythematous
Clinical narrative: This spontaneous report as received from an unspecifed reporter and the a male patient of unknown age. In August 2017, reported as this week,  the patient was vaccinated with a dose of ZOSTAVAX, subcutaneous for prophylaxis. On 15-AUG-2017, the patient experienced red bumps on his legs (rash erythematous).The outcome of rash erythematous was unknown.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse and refers to an unknown number of patients of an unknown age and gender. There was no information about the patients' pertinent medical history, concurrent conditions, concomitant therapies, and drug reactions or allergies. The reporter stated that improperly stored doses of M-M-R II lot number reported as N004433, expiration date 07-FEB-2019 (strength, dose, frequency, route of administration, and anatomical location were not reported), were administered to an unknown number of patients on an unknown date for prophylaxis. The vaccine was exposed to a temperature of 48 Fahrenheit degrees for 5 minutes. There was no previous temperature excursion and the call was not because of a "data logger". No adverse reactions reported. There was no product quality complaint involved. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a medical assistant referring to multiple unspecified patients of unknown age and gender. On an unknown date, the patient was vaccinated with improperly stored ROTATEQ (lot # and expiration date were unknown) orally for prophylaxis. The sterile diluent was properly stored. No adverse effects were reported. The stored temperature included 47 F to 77F for 42 hours, 24 F to 35 F for 35 days and below 24 F (lowest -34 F) for 12 days. There was no previous temperature excursion. Data logger was involved.
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus, Skin disorder
Clinical narrative: This spontaneous report was received from a male patient of unknown age, who was reporting on himself. On an unknown date in approximately 2015 (reported as "about two years ago"), the patient was vaccinated with ZOSTAVAX, subcutaneous injection for herpes zoster. On 23-AUG-2017, the patient experienced skin disorder and pruritus. The patient applied cortisone to treat the events. The patient did not seek medical attention yet, but had scheduled an appointment with his physician on 24-AUG-2017. The outcome of the events was reported as not recovered/not resolved at the time of this report. The relatedness between the events and ZOSTAVAX was not assessed by the reporter. Product quality complaint was not involved.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from an office manager and refers to a patient of unknown age and gender. On 06-AUG-2017 the patient was vaccinated with an expired VAQTA lot # M031695 with expiration date 26-MAY-2017 for prophylaxis. Not adverse event was reported.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age. On 23-AUG-2017 the patient was vaccinated with ZOSTAVAX lot # M042503 for prophylaxis (expiration date: 18-AUG-2017). Concomitant therapies included sterile diluent lot # L006552 (expiration date: 12-NOV-2017). No adverse effects reported.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. On 14-JUL-2017 the patient was vaccinated with the first dose of GARDASIL 9 (lot#, expiration date, dosage and route unspecified) and second dose of GARDASIL 9 (lot # N000326, expiration date of N000326; dosage and route unspecified) on 24-AUG-2017 for prophylaxis (inappropriate schedule of drug administration). No adverse effects were reported. The patient had not received a third dose of GARDASIL 9 at the time of the report.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unspecified dates, the patients were vaccinated with the improperly stored doses of ROTATEQ (lot # M022373, expiration date 20-FEB-2018; dose and route of administration were not reported). There were no adverse effects reported. Administered doses of vaccines experienced the temperature excursion of 49 degrees Fahrenheit for 36 hours. Data logger was not involved. There were no previous excursions reported. This is one of several reports received from the same reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This spontaneous report as received from a physician refers to a male patient of unknown age. In 2014 the patient was vaccinated with ZOSTAVAX, .65 ml, subcutaneous for prophylaxis. On 17-AUG-2017 the patient experienced rash. The outcome of rash is unknown.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unspecified dates, the patients were vaccinated with the improperly stored doses of VARIVAX (lot # M032495, expiration date 06-JUL-2018; dose and route of administration were not reported). There were no adverse effects reported. Administered doses of vaccines experienced the temperature excursion of 9 degrees Fahrenheit for 48 hours. Data logger was not involved. There were no previous excursions reported. This is one of several reports received from the same reporter.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: Information has been received from a medical assistant regarding unspecified number of patients (ages and genders not provided). Sometime in June 2017, the patients were vaccinated with PROQUAD  (lot# M037011, expiration date 21-APR-2018, lot# M044719, expiration date 07-MAY-2018) and sterile diluent (STERILE DILUENT). It was reported that the products were stored improperly. The sterile diluent was stored properly. PROQUAD were stored at 6F to 14F for 14 hours and 7 minutes. No previous temperature excursion. Data logger was yes. There were not reported symptoms. This is one of two reports received from the same reporter. Follow up information has been received from the reporting medical assistant on 14-AUG-2017. The reporter stated that patients were vaccinated with the above vaccines after the data logger excursion. She had the information packed away in a box, as her office was moving. She would fax the information in once the office moved.; Sender's Comments:  US-009507513-1707USA005085:
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a pharmacist referring to an unspecified number of patients of unknown age and gender. On unknown dates the patients were vaccinated with an unspecified number of doses of improperly stored ZOSTAVAX (lot # M042504 with expiration date of 30-NOV-2017, lot# N011366 with expiration date of 12-MAR-2018; dosage, frequency and route unspecified) for prophylaxis with sterile diluent (lot# M034443 with expiration date of 20-APR-2019). No adverse effects were reported. It was reported that the temperature was from -14 to -10 degree C and tie frame was 3 hours. There was no previous temperature excursion.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a registered nurse concerning patient of unknown age and gender. The patient's concurrent conditions, medical histories and concomitant therapies were not reported. On 25-AUG-2017, the patient was vaccinated with improperly stored VARIVAX injection (lot # N000683, expiration date 06-JAN-2019; strength, dose, frequency and route were unknown) for prophylaxis, which was exposed to temperature excursion of -14 to -10 degrees Celsius for 1 hour. The previous temperature excursion was -9 to 8 degrees Celsius for 1 hour. Data logger was involved. No adverse effects were reported. No product quality complaint (PQC) was involved.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant refers to multiple unspecified patients of unknown age. No information about patient's medical history, concurrent condition and concomitant medications. On an unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9, from lot # N000326 with expiry: 14-OCT-2019 (dosing details not reported) for prophylaxis. No adverse effects reported. The vaccine lot exposed to a temperature of 47 degree Fahrenheit to 77 degree Fahrenheit for 2 hours 25 minutes. It also had previous temperature excursion of 47 degree Fahrenheit to 77 degree Fahrenheit for 7 hours 45 minutes. The call was due to data logger. This is one of three reports received from the same reporter.; Sender's Comments:  US-009507513-1708USA012162: US-009507513-1708USA012163: US-009507513-1708USA012162:
Sex: F
Vaccine: HPV9
Symptoms: Anaphylactic reaction
Clinical narrative: Information has been received from a nurse practitioner via a company representative referring to a 11 year old female patient. The patient's concurrent condition, medical history and concomitant therapy were not reported. On an unknown date, the patient was vaccinated with the first dose of GARDASIL 9 (1 DF, route, lot# and expiration date unknown) for prevention of HPV. On an unknown date, the patient experienced anaphylactic reaction and had to go to the emergency room for seeking medical attention. The outcome of anaphylactic reaction was unknown. Causality was not provided. Upon internal review, the event anaphylactic reaction was considered to be medically significant.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant refers to multiple unspecified patients of unknown age. No information about patient's medical history, concurrent condition and concomitant medications. On an unknown dates, the patients were vaccinated with improperly stored doses of PEDVAXHIB from lot # N000237 with expiry: 25-OCT-2019 (dosing details not reported) for prophylaxis. No adverse effects reported. The vaccine lot exposed to a temperature of 47 degree Fahrenheit to 77 degree Fahrenheit for 2 hours 25 minutes. It also had previous temperature excursion of 47 degree Fahrenheit to 77 degree Fahrenheit for 7 hours 45 minutes. The call was due to data logger. This is one of three reports received from the same reporter. Sender's Comments: US-009507513-1708USA012148.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant refers to multiple unspecified patients of unknown age. No information about patient's medical history, concurrent condition and concomitant medications. On an unknown dates, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 from lot # M042785 with expiry: 17-JUN-2018 and lot # N011305 with expiry: 20-JAN-2019 (dosing details not reported) for prophylaxis. No adverse effects reported. The vaccine lot exposed to a temperature of 47 degree Fahrenheit to 77 degree Fahrenheit for 2 hours 25 minutes. It also had previous temperature excursion of 47 degree Fahrenheit to 77 degree Fahrenheit for 7 hours 45 minutes. The call was due to data logger. This is one of three reports received from the same reporter.; Sender's Comments: US-009507513-1708USA012148:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a medical assistant referring to a patient of unknown age and gender. On 02-AUG-2017, the patient administered an improperly stored dose of PROQUAD (dose, frequency and route unknown, lot # N012490, expiration date:17-OCT-2018) for prophylaxis. Other suspect therapies included sterile diluent (manufacturer unknown)(dose, frequency, route, lot # and expiration date unknown,)which was used to reconstitute improperly stored PROQUAD. The temperature excursion was at 6 Fahrenheit degree to 14 Fahrenheit degree for 156 hours(incorrect product storage). The previous temperature excursion was 6 Fahrenheit degree to 14 Fahrenheit degree for 4 hours and 15 Fahrenheit degree to 46 Fahrenheit degree for 1 hour. Data logger was not involved. No adverse effect was reported. This case was cross referenced with case 1708USA003212.; Sender's Comments:  US-009507513-1708USA003212:
Age: 0.58
Sex: M
Vaccine: DTAPHEPBIP, HEPA, PNC13, VARCEL
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to an unspecified 7-month-old patient. The patient's medical history, concurrent condition and concomitant medication were not reported. On 24-AUG-2017, the patient was administered with VARIVAX lot# N002204 with expiry: 19-JAN-2019 for prophylaxis, and sterile diluent (manufacturer unknown) (Drug administered to patient of inappropriate age). No adverse effects reported.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a medical assistant and refers to a 4-year-old patient of unknown gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On 11-APR-2017, the patient was vaccinated with improperly stored dose of PROQUAD lot # M041083, expiration date 04-APR-2018 (dose and route of administration were not reported). There was no adverse effect reported. Vaccine was reconstituted with properly stored sterile diluent. Administered dose of vaccine experienced the temperature excursion between 15 to 46 degrees Fahrenheit (F) (22.3 (F)) for 1 hour and 3 minutes. Digital data logger was involved. There were no previous excursions reported. No product quality complaint was involved. The reporter also stated that she had a printed report of the patients who received vaccines that had undergone the temperature excursion. The report included vaccine name, date given lot number and the name, gender and birth date of patient. This is one of several reports received from the same reporter. This is an amended report as corrected. This report was previously submitted with the incorrect Worldwide unique case identification number "US-009507513-1705USA005093", and this new follow-up submission is to provide the correct identification number "US-009507513-1706USA003936". "US-009507513-1705USA005093" is an existing case, therefore this safety report is not being nullified, just updated to reflect correct Worldwide Unique identification number. Additional information is not expected as all relevant correspondence has already been received. Sender's Comments: US-009507513-1705USA005086: US-009507513-1705USA005094: US-009507513-1706USA003934: US-009507513-1706USA003935: US-009507513-1705USA005093: US-009507513-1706USA003937.
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative
Clinical narrative: This spontaneous report as received from a female nurse of unknown age referring to herself. On an unknown date, the patient was vaccinated with a 3 dose series of RECOMBIVAX HB (lot #, expiration date and route not reported) for prophylaxis. On an unknown date, the patient's titers were negative, and she competed another 3 dose series of RECOMBIVAX HB. The outcome of hepatitis b antibody negative was unknown. Causality assessment was not provided. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1708USA012259.
Age: 15.0
Sex: F
Vaccine: HEPA, HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant therapy were reported. On 07-AUG-2017, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (lot # M007764, expiration date 30-JAN-2018) (dosage, frequency and route were not reported) for prophylaxis (incorrect product storage). No adverse effect reported. The vaccine was stored at a temperature from 0 degree centigrade to 1 degree centigrade for 1 hour 45 minutes and -1 degree centigrade or colder (-6.09 degree centigrade) for 9 hours 45 minutes. There was no previous temperature excursion. Data logger was involved. No product quality complaint was involved. No further information was provided. This is one of several reports received from same reporter. Sender's Comments: US-009507513-1708USA005685:
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant therapy were reported. On 07-AUG-2017, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (lot # M017983, expiration date 30-MAY-2018) (dosage, frequency and route were not reported) for prophylaxis (incorrect product storage). No adverse effect reported. The vaccine was stored at a temperature from 0 degree centigrade to 1 degree centigrade for 1 hour 45 minutes and -1 degree centigrade or colder (-6.09 degree centigrade) for 9 hours 45 minutes. There was no previous temperature excursion. Data logger was involved. No product quality complaint was involved. No further information was provided.  This is one of several reports received from same reporter.; Sender's Comments: US-009507513-1708USA005043:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a medical assistant concerning an unspecified number of patients of unknown age and gender. The patients' concomitant medications, pertinent medical history, and drug reactions and allergies have not been provided. On unknown dates, these multiple unspecified patients were possibly vaccinated with improperly stored ROTATEQ (strength and dose unknown, lot # M045545, expiration date 10-JUN-2018) orally for prophylaxis. The ROTATEQ was exposed 49.8 F for a time frame of 7 hours. There were no previous temperature excursions. A data logger was in use. No adverse effects reported.
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Injection site rash, Malaise
Clinical narrative: This spontaneous report as received from the patient's friend concerning a male patient of unknown age. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On an unknown date, the patient was vaccinated with ZOSTAVAX (dosing details, lot#, expiry date and anatomical location were unknown) for prophylaxis. On an unknown date post vaccination, the patient felt "sick and tired" and developed a rash at the injection site. The outcome of malaise, injection site rash and fatigue was unknown. The reporter did not provide the causality between the events and ZOSTAVAX. There were no product quality complaints (PQC) involved.
Sex: U
Vaccine: HEP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to multiple patients of unknown age and gender. On an unknown date, the patients were vaccinated with RECOMBIVAX HB (dose, lot #, expiration date and route not reported) for prophylaxis. On an unknown date, the patients were administered a 4th dose of RECOMBIVAX HB due to insufficient records. No adverse effects were reported. experienced extra dose administered and no adverse event. This is one of two reports received from the same reporter.; Sender's Comments: US-009507513-1708USA001224:
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Contusion, Injection site erythema, Injection site nodule, Pain in extremity
Clinical narrative: 8/26 Patient returned to pharmacy 48 hours after receiving vaccine and and reported severe arm pain, knot at injection site, and slight redness. The patient was assessed and denied having any of the following: hives, difficulty breathing, fever, tingling in the arms or feet. After physical assessment it was determined to be a severe injection site reaction and the patient was advised to take ibuprofen and use ice on and off. The patient was also instructed to seek medical attention if she developed a fever, difficulty breathing, the redness became more severe or if she had any reason to suspect it was getting worse. 8/27 Patient was contacted the following day and told the pharmacy she was feeling better. 8/28 Patient came in to pharmacy and there was bruising on her arm, but stated it does feel better than it previously did.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Musculoskeletal stiffness, Presyncope, Seizure like phenomena, Tremor
Clinical narrative: Mother of Patient states child experienced vasovagal but shortly after showed some seizure like symptoms. Armed stiffened up and child began to shake for a few seconds.
Sex: M
Vaccine: MENB
Symptoms: Death, Meningitis, Vaccination failure
Clinical narrative: This case was reported by a consumer and described the occurrence of vaccination failure in a male patient who received BEXSERO. On an unknown date, the patient received BEXSERO at an unknown dose. On an unknown date, unknown after receiving BEXSERO, the patient experienced vaccination failure (serious criteria GSK medically significant) and meningitis (serious criteria death and GSK medically significant). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the meningitis was fatal. The reported cause of death was meningitis. It was unknown if the reporter considered the vaccination failure and meningitis to be related to BEXSERO. Additional details were provided as follows: The reporter reported this case for his/her friend's boyfriend. The age at vaccination was not reported. The patient had contracted meningitis from after receiving BEXSERO and died. This case was considered as suspected vaccination failure since the completion of vaccination schedule, time to onset of event and confirmatory laboratory test were unknown.
Age: 42.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Injection site urticaria, Injection site warmth
Clinical narrative: Patient developed initial injection site reaction that included swelling, red, warm welt on arm. Now has extended to include swelling of face and neck.
Age: 42.0
Sex: F
Vaccine: PPV
Symptoms: Local swelling, Swelling face
Clinical narrative: Patient developed initial injection site reaction that included swelling, red, warm welt on arm. Now has extended to include swelling of face and neck.
Sex: U
Vaccine: PNC13, TDAP, VARZOS
Symptoms: Herpes zoster
Clinical narrative: Patient diagnosed with shingles on 08/28/2017.
Age: 18.0
Sex: F
Vaccine: DTAP
Symptoms: Wrong drug administered
Clinical narrative: Patient was given Dtap INFANRIX and was supposed to be given Tdap for 7 years and up.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Clavicle fracture, Concussion, Electrocardiogram QT prolonged, Fall, Loss of consciousness
Clinical narrative: Patient passed out several minutes after vaccine was administered. She fell off the exam table and sustained a concussion and fractured left clavicle. EKG immediately following showed a borderline long QT which resolved upon reexamination one week later.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: X-ray abnormal
Clinical narrative: Patient passed out several minutes after vaccine was administered. She fell off the exam table and sustained a concussion and fractured left clavicle. EKG immediately following showed a borderline long QT which resolved upon reexamination one week later.
Age: 61.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient developed initial swelling, redness and pain around injection site. Reaction extended to rest of upper arm. Patient is receiving doses of diphenhydramine.
Age: 61.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Erythema, Pain, Urticaria
Clinical narrative: Patient developed initial swelling, redness and pain around injection site. Reaction extended to rest of upper arm. Patient is receiving doses of diphenhydramine.
Age: 18.0
Sex: M
Vaccine: HPV9
Symptoms: CSF test, Guillain-Barre syndrome
Clinical narrative: Acute inflammatory demyelinating polyneuropathy (AIDP).
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant refers to a one unspecified patient of unknown age. On an unknown date, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot number reported as M003703, for prophylaxis. The vaccine was exposed to a temperature ranges between 47°Fahrenheit (F) to 77°F, during a time frame of 30 minutes which was call by a data logger with no previous temperature excursions. Lot number M003703 is an invalid lot number for GARDASIL 9. This is one of several reports from the same source. Sender's Comments: US-009507513-1708USA004846: US-009507513-1708USA004847.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other refers to a patient of unknown age. On 26-AUG-2017 the patient was vaccinated with ZOSTAVAX lot # N016185 for prophylaxis. Concomitant therapies included sterile diluent (MERCK). On 26-AUG-2017, 1 day after onset of therapy the patient experienced incorrect product storage. On an unknown date the patient experienced no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to ZOSTAVAX. {Additional information has been requested. Additional information is not expected.}
Sex: M
Vaccine: FLU4
Symptoms: Influenza like illness, Nausea, Vomiting
Clinical narrative: Initial unsolicited case received from a health care professional (pharmacy intern) on 17 Aug 2017. This case involves a male patient (age not reported) who was vaccinated with a dose of FLUZONE (Batch number, expiry date, dose, dose in series, route, and site of administration were not reported) on 16 Aug 2017. The patient illness at the time of vaccination, pre-existing physician diagnosed allergies, birth defects, medical conditions were reported as unknown, and any other vaccinations within 4 weeks of vaccinations was unknown. Concomitant medications were not reported. On 17 Aug 2017, one day after the vaccination, the patient developed nausea, vomiting and general flu like symptoms. The patient required to seen in ER (emergency room) / doctor visit (also reported as the reporter advise her that if the symptoms are concerning they should see their primary provider.) No relevant laboratory examination were performed. Corrective treatment was not reported. The outcome of all the events were reported as not recovered. List of documents held by sender: none.