chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 9.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema
Clinical narrative: Large red reaction at injection site 1/2 dollar size. TX: Antihistamine and cool compresses.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Dehydration, Dizziness, Hypertension, Nausea
Clinical narrative: Had on Tuesday, woke up Wednesday with nausea, dizziness, chills. Mostly intense nausea. Seen in ER x 2. Dehydrated-given IVs ad nausea meds.
Age: 73.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Blood potassium decreased, Chills, Diarrhoea, Myalgia, Nausea
Clinical narrative: Chills, nausea, muscle pain, diarrhea. Pt thinks related to vaccine.
Age: 14.0
Sex: F
Vaccine: FLU4, HPV4
Symptoms: Injection site mass, Injection site pain
Clinical narrative: Pt was seen 2 wks after injection-arm still slightly sore but still has a lump at injection site.
Age: 60.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site rash, Oral mucosal eruption, Pruritus
Clinical narrative: Rash on arm by ZOSTAVAX injection site and rash by mouth; itching.
Age: 22.0
Sex: F
Vaccine: FLU4
Symptoms: Pain, Pain in extremity, Pyrexia
Clinical narrative: Pt received vaccine on 11/16/16 and said she had a high fever about 101-102 and sore arm and body aches. Took MOTRIN and saw Dr next day and her primary care said she might have had a reaction to the vaccine. Spoke to her on 11/22/16.
Sex: F
Vaccine: MENB
Symptoms: Swelling
Clinical narrative: This is a spontaneous report from a contactable physician communicated to a Pfizer sales representative. This is the first of two reports. A 16-year-old female patient of an unspecified ethnicity started to receive TRUMENBA, via an unspecified route of administration at single dose on an unspecified date. The patient medical history and concomitant medications were not reported. The patient experienced 2 to 3 cm swollen area on an unspecified date with outcome of unknown. Follow-up (12OCT2016): Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: HPV9, MENB, MNQ
Symptoms: Fatigue, Headache, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This is a spontaneous report from a contactable Physician via Pfizer sales representative. A male patient of an unspecified age (16, Unit: unknown) and ethnicity received TRUMENBA, via an unspecified route of administration on an unspecified date at single dose in the left arm for immunisation, MENACTRA, via an unspecified route of administration on an unspecified date at an unspecified dose in the left arm for immunisation and HPV9, via an unspecified route of administration on an unspecified date at an unspecified dose in the right arm for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced severe headache, severe fatigue, severe pain, redness, and swelling at the injection site on an unspecified date with outcome of unknown. Follow-up (09OCT2016): Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: MENB
Symptoms: Chills, Headache, Tremor
Clinical narrative: This is a spontaneous report from a contactable Physician via Pfizer sales representative, reporting for 4 patients. For one of the patients 2 cases were reported regarding to different doses: this is the 2nd report regarding the events occurred with the 2nd dose received. An 18-year-old male patient of unspecified ethnicity received TRUMENBA via an unspecified route, at single dose on 07Jan2016, on 10Mar2016 and on 20Jul2016 for immunisation. No medical history or concomitant medications were reported. The patient previously received the 1st dose and experienced redness and swelling on 07Jan2016. The patient experienced chills, headache and shaking on 10Mar2016. The outcome of the events was unknown. The patient experienced no events with the vaccination received on 20Jul2016. Follow-up (09OCT2016): Follow-up attempts are completed. No further information is expected.
Age: 18.0
Sex: F
Vaccine: HPV4, MENB
Symptoms: Chills, Feeling cold, Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable consumer (mother). An 18-year-old female patient received first dose of TRUMENBA at 0.5 ml single dose in the left arm on 25Aug2016 1.30 and GARDASIL on 25Aug2016 at 1 DF single in the left arm. Medical history and concomitant medications were not reported. On 25Aug2016, the patient had arm hurting (explained as sore all day) and chills described also as a goose bump feeling like she was freezing. Outcome was recovering. Follow-up (28OCT2016): Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: MENB
Symptoms: Chills, Fatigue, Headache, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable healthcare professional received via a sales representative. A 19-year-old male patient received the second dose of TRUMENBA on an unspecified date at single dose. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced fatigue, fever, headache, chills, all on an unspecified date, with outcome of recovered by the second day post-vaccination.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a pharmacist referring to a 73 year old female patient. The patient was allergy to penicillin. Concomitant therapies included FLOVENT. On 03-NOV-2016, the patient was vaccinated with a dose of PNEUMOVAX 23, 0.5 ml (route, lot# and expiration date unknown). On 04-NOV-2016, the patient went to the pharmacy and showed the pharmacist an area of about 3 inches by 8 inches around the injection site that was red and swollen. No treatment was given for the event and no lab was performed. The patient had not recovered from the events at the reporting time. The causal relationship between the events and PNEUMOVAX 23 was unknown. Additional information has been requested.
Age: 53.0
Sex: U
Vaccine: TDAP
Symptoms: Lymphadenopathy
Clinical narrative: Grossly swollen lymph nodes in collar bone region after TDAP vaccine.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report received from a nurse referred to patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. The nurse reported that the patient was vaccinated with an improperly stored PROQUAD (dose, route was not reported) (Lot number: M021427; expiry date: 29-OCT-2017) on 21-NOV-2016. The vaccine was stored at 72.6 F for 69 hours. There was no previous temperature excursion. No adverse symptoms reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a three unspecified patients of unknown age and gender. No pertinent medical history, drug reactions/allergies and concomitant medications were reported. On an unknown date the patient was vaccinated with improperly stored doses of ZOSTAVAX (lot # L035504 and expiry date 16-DEC-2016) (dosing regiment unknown). The vaccine was exposed to temperature excursion of 20 F for 3 hours. Previously the vaccine was exposed to 34 F for 3 hours. The call was due to data digital logger. No adverse effects were reported. No product quality complaint (PQC) was filed. This case was cross linked with the case 1611USA011011 via same reporter link. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant concerning multiple unspecified patients of unknown age and gender. The patient's concurrent conditions and medical history were not provided. It was reported that, on unspecified dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB lot #: L019299, expiration date: 15-APR-2017 and lot #: 027733, expiration date: 13-SEP-2017 (dose and route were not provided), which had a temperature excursion of 1.9 Celsius Degrees for 17 minutes. It was reported that the temperature excursion was detected with a data logger and that the vaccines had no prior excursions. There were no concomitant medications and adverse effects reported. No product quality complaint was involved. This is one of several reports from the same reporter. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling
Clinical narrative: This spontaneous report was received from a pharmacist via company representative referring to a 68 year old female patient. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant medications were unknown. Approximately in October 2016 (also reported as "about a month ago"), the patient was vaccinated with PNEUMOVAX 23 (Lot number, expiration date, dose and route were not provided) in the arm (unspecified). Approximately in October 2016 (also reported as "about a month ago"), the patient's upper arm and shoulder became puffy, swollen and redness after receiving PNEUMOVAX 23. The patient sought for medical attention; she went to primary care physician. At the time of the report, the outcome of peripheral swelling and erythema was reported as recovered/resolved. The reporter did not assess the causal relationship between the adverse events and the vaccination with PNEUMOVAX 23. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant concerning multiple unspecified patients of unknown age and gender. The patient's concurrent conditions and medical history were not provided. It was reported that, on unspecified dates, the patients were vaccinated with improperly stored doses of ROTATEQ lot # M002254, expiration date: 17-NOV-2017 and lot #: M019690, expiration date: 02-NOV-2017, orally, which had a temperature excursion of 1.9 Celsius Degrees for 17 minutes. It was reported that the temperature excursion was detected with a data logger and that the vaccines had no prior excursions. There were no concomitant medications and adverse effects reported. No product quality complaint was involved. This is one of several reports from the same reporter. Additional information has been requested.
Sex: M
Vaccine: MENB
Symptoms: Erythema, Injection site pain, Neck pain, Pain in extremity, Rash
Clinical narrative: This is a spontaneous report from a contactable physician via a Pfizer sales representative. This physician reported similar events for four patients. This is the third of four patients. A male patient of an unspecified age and ethnicity received a single dose of TRUMENBA via an unspecified route of administration on an unspecified date. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced huge rash probably like a whole foot long (rash), swelling, very red and warm to touch, severe pain at the injection site that went all the way up to the back of their neck and all the way down to their hands. The events were described as pain at the injection site, large redness, and swelling with hotness, radiating pain both to the neck and all the way down to the hands. Therapeutic measures were taken as a result of events and included MOTRIN and BENADRYL. Clinical outcome of the adverse events was unknown at time of this report. Follow-up (29-SEP-2016): Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: MENB
Symptoms: Skin warm, Swelling
Clinical narrative: This is a spontaneous report from a contactable physician via a Pfizer sales representative. This physician reported similar events for four patients. This is the third of four patients. A male patient of an unspecified age and ethnicity received a single dose of TRUMENBA via an unspecified route of administration on an unspecified date. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced huge rash probably like a whole foot long (rash), swelling, very red and warm to touch, severe pain at the injection site that went all the way up to the back of their neck and all the way down to their hands. The events were described as pain at the injection site, large redness, and swelling with hotness, radiating pain both to the neck and all the way down to the hands. Therapeutic measures were taken as a result of events and included MOTRIN and BENADRYL. Clinical outcome of the adverse events was unknown at time of this report. Follow-up (29-SEP-2016): Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant concerning multiple unspecified patients of unknown age and gender. The patient's concurrent conditions and medical history were not provided. It was reported that, on unspecified dates, the patients were vaccinated with improperly stored doses of GARDASIL Lot #: M014929, expiration date: 27-MAY-2017 (strength, dose and route were not provided), which had a temperature excursion of 1.9 Celsius Degrees for 17 minutes. It was reported that the temperature excursion was detected with a data logger and that the vaccines had no prior excursions. There were no concomitant medications and adverse effects reported. No product quality complaint was involved. This is one of several reports from the same reporter. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from female consumer of unknown age, referring to herself. Medical history, concurrent conditions and concomitant therapies were not reported. In approximately November 2013, reported as "3 years" previous, the patient was vaccinated with a dose of ZOSTAVAX, reported as one time immunization (strength, frequency, dose, route, lot/batch number and expiration date were not reported). The reporter stated that she was diagnosed with Shingles 3 years after receiving ZOSTAVAX, in approximately November 2016 reported as "a couple of days ago". The outcome of shingles was unknown. The relationship of shingles and ZOSTAVAX was not provided. There was no Product Quality Complain (PQC). Additional information is not expected as the patient did not wish to provide healthcare professional (HCP) contact details.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant concerning multiple unspecified patients of unknown age and gender. The patient's concurrent conditions and medical history were not provided. It was reported that, on unspecified dates, the patients were vaccinated with improperly stored doses of VAQTA Lot #: L018499, expiration date: 25-FEB-2017, Lot #: M017982, expiration date: 13-SEP-2017, Lot #: M022924, expiration date: 24-JAN-2018 and Lot #: L031196, expiration date: 05-FEB-2017, which had a temperature excursion of 1.9 Celsius Degrees for 17 minutes. It was reported that the temperature excursion was detected with a data logger and that the vaccines had no prior excursions. There were no concomitant medications and adverse effects reported. No product quality complaint was involved. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant concerning multiple unspecified patients of unknown age and gender. The patient's concurrent conditions and medical history were not provided. It was reported that, on unspecified dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 Lot #: M023169, expiration date: 13-JUN-2018 (strength, dose and route not provided), which had a temperature excursion of 1.9 Celsius Degrees for 17 minutes. It was reported that the temperature excursion was detected with a data logger and that the vaccines had no prior excursions. There were no concomitant medications and adverse effects reported. No product quality complaint was involved. This is one of several reports from the same reporter. 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 medical assistant concerning multiple unspecified patients of unknown age and gender. The patient's concurrent conditions and medical history were not provided. It was reported that, on unspecified dates, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 Lot #: M020521, expiration date: 17-NOV-2017 and lot # M027552, expiration date: 04-FEB-2018 (strength, dose and route were not provided), which had a temperature excursion of 1.9 Celsius Degrees for 17 minutes. It was reported that the temperature excursion was detected with a data logger and that the vaccines had no prior excursions. There were no concomitant medications and adverse effects reported. No product quality complaint was involved. This is one of several reports from the same reporter. Additional information has been requested.
Sex: M
Vaccine: MENB
Symptoms: Erythema, Injection site pain, Neck pain, Pain in extremity, Rash
Clinical narrative: This is a spontaneous report from a contactable physician via a Pfizer sales representative. This physician reported similar events for four patients. This is the fourth of four patients. A male patient of an unspecified age and ethnicity received a single dose of TRUMENBA via an unspecified route of administration, on an unspecified date. The patient  medical history and concomitant medications were not reported. On an unspecified date, the patient experienced huge rash probably like a whole foot long (rash), swelling, very red and warm to touch, severe pain at the injection site that went all the way up to the back of their neck and all the way down to their hands. The events were described as pain at the injection site, large redness and swelling with hotness, radiating pain both to the neck and all the way down to the hands. Therapeutic measures were taken as a result of events and included MOTRIN and BENADRYL. Clinical outcome of the adverse events was unknown at time of this report.  Follow-up (29SEP2016): Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: MENB
Symptoms: Skin warm, Swelling
Clinical narrative: This is a spontaneous report from a contactable physician via a Pfizer sales representative. This physician reported similar events for four patients. This is the fourth of four patients. A male patient of an unspecified age and ethnicity received a single dose of TRUMENBA via an unspecified route of administration, on an unspecified date. The patient  medical history and concomitant medications were not reported. On an unspecified date, the patient experienced huge rash probably like a whole foot long (rash), swelling, very red and warm to touch, severe pain at the injection site that went all the way up to the back of their neck and all the way down to their hands. The events were described as pain at the injection site, large redness and swelling with hotness, radiating pain both to the neck and all the way down to the hands. Therapeutic measures were taken as a result of events and included MOTRIN and BENADRYL. Clinical outcome of the adverse events was unknown at time of this report.  Follow-up (29SEP2016): Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On 11-NOV-2016, the patient was inadvertently vaccinated with an improperly stored dose of PROQUAD (rHA) Lot # reported as M033612, expiration date:14-JAN-2018 (Strength and dose were not reported), via subcutaneous, which experienced a temperature excursion of 6 Celsius degrees for 96 hours and 30 minutes. No previous temperature excursions were reported. Data logger was not involved. No adverse effects were reported. Additional information is not expected since the reporter did not wish to be contacted.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information was received on 09-NOV-2016 from an unspecified reporter, regarding a patient of unknown age and gender. The patient's medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB (strength, dose and route were not reported) with lot number M007763 (unspecified expiration date). No adverse experiences were reported. This is one of several reports received from the same reporter. Additional information is not expected.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a health professional referring to multiple patients of unknown age and gender. The patients medical history and concurrent conditions were not reported. On an unknown date, the patients were vaccinated with PROQUAD lot number M022401, expiration date: 01-NOV-2017 (concentration, dose, frequency and via were not reported), which was improperly stored at 32.5 fahrenheit degrees for 16 hours. No previous temperature excursion was reported and it was not detected due to a data logger. No adverse effect was reported. Lot number M022401 has been verified to be a valid lot number for PROQUAD. It was also reported the Albumin status as rHA. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information was received on 09-NOV-2016 from an unspecified reporter, regarding a patient of unknown age and gender. The patient's medical history and concomitant medications were not reported. On an unknown date, the patient  was vaccinated with an improperly stored dose of RECOMBIVAX HB (strength, dose and route were not reported) with lot number M007763 (unspecified expiration date). No adverse experiences were reported. This is one of several reports received from the same reporter. Additional information is not expected.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information was received on 09-NOV-2016 from an unspecified reporter, regarding a patient of unknown age and gender. The patient's medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (strength, dose, lot number and route were not reported). No adverse experiences were reported. This is one of several reports received from the same reporter. Additional information is not expected.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information was received on 09-NOV-2016 from an unspecified reporter, regarding a patient of unknown age and gender. The patient's medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (also reported as Pneumococcal (PCV13)) with lot number M003027 (strength, dose, expiration date and route were not reported). No adverse experiences were reported. This is one of several reports received from the same reporter. Additional information is not expected.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report was received from a nurse referring to a 60 year old female patient. The patient's pertinent medical history and concomitant therapies were not reported. Concurrent conditions included high cholesterol. Drug/allergies reactions included hypersensitivity to morphine and codeine. On 08-NOV-2016, the patient was vaccinated with a 0.65 ml dose of ZOSTAVAX subcutaneously, lot # M027117, expiration date 26-JUL-2017. On 08-NOV-2016, the patient developed redness, erythema and swelling at the ZOSTAVAX injection site, the reporter also mentioned that the injection site grew in size to be 7 centimeters by 11 centimeters. On 10-NOV-2016, the patient visited a medical facility in regards to the events, and was prescribed with cephalexin and an unspecified antihistamine as treatment. There were no laboratory diagnostics studies performed. The outcome of injection site erythema and injection site swelling was not recovered. This is one of several reports received from the same source. No product quality complaint (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information was received on 09-NOV-2016 from an unspecified reporter, regarding a patient of unknown age and gender. The patient's medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of {PNEUMOVAX 23 0.5ml, lot number M003027 (dose, expiration date and route were not reported). No adverse experiences were reported. This is one of several reports received from the same reporter. Additional information is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a eight unspecified patients of unknown age and gender. No pertinent medical history, drug reactions/allergies and concomitant medications were reported. On an unknown date the patient was vaccinated with improperly stored doses of VARIVAX (lot # M009768 and expiry date 23-FEB-2018) (dosing regimen unknown). The vaccine was exposed to temperature excursion of 20 F for 3 hours. Previously the vaccine was exposed to 34 F for 3 hours. The call was due to data digital logger. No adverse effects were reported. No product quality complaint (PQC) was filed. This case was cross linked with the case 1611USA010902 via same reporter link. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a certified medical assistant referring to an unspecified number of patients of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On unknown dates between 18-AUG-2016 and 15-NOV-2016, the patients received improperly stored ZOSTAVAX (lot # L037791 with expiration date 30-DEC-2016; lot # M010486 with expiration date 25-MAY-2017; dose and route were unknown. The vaccines were stored under the temperature 15.5 Fahrenheit degree for 1 hour and 11 minutes. A digital data logger was involved. There was no previous excursion for ZOSTAVAX. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Vaccination complication
Clinical narrative: This spontaneous report as received from a patient's mother refers to a patient of unknown age and gender. No medical history, concomitant medications, concurrent conditions or drug reactions and allergies were reported. On an unknown date, the patient was vaccinated with a dose of ROTATEQ orally, (lot #, expiry date, and dose were not reported). On an unknown date, the patient experienced unspecified reaction to ROTATEQ. The outcome of the event was unknown at the time of the report. The reporter considered vaccination adverse reaction to be related to ROTATEQ. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Fatigue, Oedema peripheral
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient (also reported as pharmacist) of unknown age. On an unknown date, the patient was vaccinated with PNEUMOVAX 23. On an unknown date, the patient experienced edema on her arm and fatigue. The outcome of oedema peripheral and fatigue was unknown. The reporter did not provide the causality between the events and the suspect therapy. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Incorrect route of drug administration
Clinical narrative: This spontaneous report was received from a nurse and refers to a 14 year old female patient. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 14-NOV-2016, the patient was subcutaneously vaccinated with a dose of GARDASIL 9 injection (site of administrations, dose, lot number and expiration date were not reported). On the same day, after being vaccinated, the patient felt dizzy. Product quality complain was not involved. The outcome of feeling dizzy and the relatedness between this event and the vaccination with GARDASIL 9 were not reported. No further information was provided. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse who refers to unspecified patients of unknown age. On unspecified dates, since 15-JUL-2016, patients were vaccinated with PEDVAXHIB lot # M020100, expiration date 07-MAR-2019 and lot # M027882, expiration date 14-APR-2019. The registered nurse reported that doses of improperly stored PEDVAXHIB lot # M020400, expiration date 07-MAR-2019 and lot # M027882, expiration date 14-APR-2019 have been administered to unspecified patients on unspecified dates since 15-JUL-2016. Temperature and Time frame: 48.2F for 12 minutes. There were no previous temperature excursion. The call was placed because of a "data logger". No adverse event have been reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse practitioner referring to  3 patients of unknown age and gender. The patients' concurrent conditions and medical history were not reported. On 27-OCT-2016, each of the patients were vaccinated with a dose of improperly stored PROQUAD lot # M021428, an expiration date 29-OCT-2018 (dose, frequency, route of administration and indication were not reported). The vaccines were exposed to temperature of 8.8F for 3 hours and 26 minutes and to temperature of 30.2F for 1 hour and 54 minutes, the data logger was involved. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse (LPN) refers to a patient of unknown age. On 29-JUN-2015 the patient was vaccinated with first dose of GARDASIL lot # K016966, expiration 10-MAY-2017). On 01-JUL-2016, the patient was vaccinated with GARDASIL 9 (M004116, expiration 12-OCT-2017 as the second dose of the series. It was reported the patient experienced no adverse event. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse practitioner referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 27-OCT-2016, the patient was vaccinated with a dose of improperly stored VARIVAX lot # M027343, an expiration date 10-JUN-2018 (dose, frequency, route of administration were not reported). The vaccine was exposed to temperature of 8.8F for 3 hours and 26 minutes and to temperature of 30.2F for 1 hour and 54 minutes, the data logger was involved. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: Information has been received from pharmacist who learned from a nurse, concerning an unspecified patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concurrent conditions were not informed. On an unspecified date in 2016, reported as "earlier in the year, maybe 6 months ago", the patient was vaccinated with one dose of ZOSTAVAX (lot #, expiration date and therapy route were not provided). Concomitant therapies were not informed. In November of 2016, reported as "last week", the patient received a second dose of ZOSTAVAX (lot #, expiration date and therapy route were not provided). The outcome of the event was unknown. 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 as received from a nurse refers to an unspecified patient of unknown age. On 01-NOV-2016 the patient was vaccinated with VARIVAX lot # M024680, (conflicting information, also reported as M023680) expiration date 18-MAY-2018 subcutaneous. The nurse reported that an improperly stored dose of VARIVAX lot # M024680, expiration date 18-MAY-2018, was administered to an unspecified patient on 01-NOV-2016. No adverse effects reported. The outcome of incorrect product storage and no adverse event is unknown. No further information available. VARIVAX lot # M024680, expiration date 18-MAY-2018: Temperature: 7.3C. Time frame: 1 hour. Call due to a data logger: Yes. No previous excursions. Additional information has been requested.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistance refers to an unspecified number of patients of unknown age. On an unknown date, the patients were vaccinated with VARIVAX, lot # M010482, expiration date 01-MAR-2018 and lot # M017290, expiration date 07-APR-2018 and PROQUAD, lot # M001152, expiration date 05-JUL-2017 and lot # M017335, expiration date 05-OCT-2017. The medical assistant reported that an unspecified number of patient have received improperly stored VARIVAX lot # M010482, expiration date 01-MAR-2018 and lot # M017290, expiration date 07-APR-2018 and PROQUAD, lot # M001152, expiration date 05-JUL-2017 and lot # M017335, expiration date 05-OCT-2017 on unspecified dates since AUG-2016. No symptoms were reported. The outcome of incorrect product storage and no adverse event is unknown. Previous temperature excursion: PROQUAD, lot # M001152, expiration date 05-JUL-2017 (had a previous excursion of 15.8F for 40 minutes) and lot # M017335, expiration date 05-OCT-2017 (had a previous excursion). VARIVAX lot # M010482, expiration date 01-MAR-2018 (had a previous excursion of 15.8F for 40 minutes) and lot # M017290, expiration date 07-APR-2018 (had a previous excursion of 15.8F for 40 minutes). Temperature: 16.1F. Time frame: 2 hours. Data logger: yes. 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 registered nurse refers to unspecified patients of unknown age. On an unknown date the patients was vaccinated with (Oka/Merck) VARIVAX lot # L050956, expiration date 17-DEC-2017 and lot # M008171, expiration date 16-FEB-2018, subcutaneous. The registered nurse reported that improperly stored doses of (Oka/Merck) VARIVAX lot # L050956, expiration date 17-DEC-2017 and lot # M008171, expiration date 16-FEB-2018 have been administered to unspecified patients on unspecified dates since 04-OCT-2016. No adverse effects have been reported. The outcome of incorrect product storage and no adverse event is unknown. No further information provided. Temperature: 12.7F. Time frame: 8 hour, 10 minutes. No previous temperature excursions. Call was due to a data logger: Yes. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a vaccine coordinator refers to unspecified patients of unknown age and gender. The concurrent conditions, drug reactions/allergies and medical history of the patients were not reported. On unknown dates, the patients were vaccinated with a dose of improperly stored PEDVAXHIB with lot number M020100 and expiration date of 07-MAR-2019 (strength, route of administration, anatomical location and dose were unknown), which was stored at 47.5 Fahrenheit degrees for 1 hour and 32.9 Fahrenheit degrees for 1 hour. There was no previous temperature excursion. The temperature excursions were detected by a data logger. There were no concomitant therapies reported. No product quality complaint was involved. This is one of several cases from the same reporter. 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 licensed practical nurse refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates in 2016 (reported as "since 05-OCT-2016"), the patients were vaccinated with an unspecified number of doses of improperly stored GARDASIL 9 lot# M007764 with expiration date: 30-JAN-2018 and M009378 with expiration date: 23-APR-2018 (dose and route of administration were not reported). Administered doses of GARDASIL 9 underwent temperature excursions at 35 Fahrenheit degrees, for 45 hours. There were no previous temperature excursions. Data logger was not involved. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of two reports received from the same reporter. 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 licensed practical nurse referring to a multiple unspecified patients of unknown age and genders. The patients' pertinent medical history or concurrent conditions were not provided. On multiple unspecified dates, the patients were vaccinated with improperly stored PEDVAXHIB intramuscular Injection (strength, dose, route, anatomical location, lot number and expiration were not reported. Co-suspect therapies or concomitant medications were not provided. No adverse reactions were reported. It was reported that the therapy was not discontinued. There was no product quality complaint (PQC) involved. This was one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse, referring to an unspecified number of patients of unknown ages and genders. The patients' medical history, concurrent conditions and concomitant therapies were not reported. In 2016 (reported as on unspecified dates in September 2016 and October 2016), the patients were vaccinated with an improperly stored dose of PNEUMOVAX 23 lot # L018503, expiration date 16-MAR-2017; lot # M029680, expiration date 17-JAN-2017 and lot # M036161, expiration date 06-MAY-2018 (dose, strength, anatomical location and administration route were not provided). No symptoms were reported. The vaccine had a previous temperature excursions of 30 minutes at 57 Fahrenheit (F). Temperature: 54 F. Time frame: 1 hour. With a data logger involved. No product quality complaint (PQC) was involved. This is one of two reports received from the same source. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: MNQ
Symptoms: Rhinorrhoea, Throat irritation
Clinical narrative: Upper resp. symptoms prior to shot. Itchy throat 12 hours after shot, nasal drainage.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown dates in 2016 (reported as "since 05-OCT-2016"), the patients were vaccinated with an unspecified number of doses of improperly stored ROTATEQ orally, lot# M004885 with expiration date: 23-OCT-2017 and lot# M007298 with expiration date: 19-NOV-2017 (dose was not reported). Administered doses of ROTATEQ underwent temperature excursions at 35 Fahrenheit degrees, for 45 hours. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPVX
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a vaccine coordinator refers to unspecified patients of unknown age and gender. The concurrent conditions, drug reactions/allergies and medical history of the patients were not reported. On unknown dates, the patients were vaccinated with a dose of improperly stored GARDASIL 9 with either lot number L037554 and expiration date of 25-DEC-2017 or lot number M018810 with expiration date of 28-MAY-2017 (strength, route of administration and dose were not reported), which was stored at 47.5 Fahrenheit degrees for 1 hour and 32.9 Fahrenheit degrees for 1 hour. There was no previous temperature excursion. The temperature excursions were detected by a data logger. There were no concomitant therapies reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse, referring to an unspecified number of patients of unknown ages and genders. The patients' medical history, concurrent conditions and concomitant therapies were not reported. In 2016 (reported as on unspecified dates in September 2016 and October 2016), the patients were vaccinated with an improperly store dose of ROTATEQ, administered orally; lot # L33694, expiration date 16-JUN-2017; lot # M016238, expiration date 07-DEC-2017 and lot # M017514, expiration date 07-NOV-2017 (dose, strength and anatomical location were not provided). No symptoms were reported. The vaccine had previous temperature excursions of 30 minutes at 57 Fahrenheit (F). Temperature: 54 F. Time frame: 1 hour. With a data Logger involved. No product quality complaint (PQC) was involved. This is one of two reports received from the same source. Additional information has been requested.
Sex: M
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: This spontaneous report was received from a physician via company representative referring to a 20 year old male patient. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant medication were unknown. Approximately in July 2016 (also reported as "4 months ago"), the patient was vaccinated with the first dose of GARDASIL 9 (Lot number and expiration date were not provided) 0.5 ml, intramuscular. After the patient received the vaccination (approximately in July 2016) he experienced a vasovagal syncope response. The patient did not seek for medical attention. The outcome of vasovagal syncope was reported as recovered/resolved on an unspecified date in 2016. The reporter did not assess the causal relationship between the adverse event and the vaccination with GARDASIL 9. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to a unspecified number of patients of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On an  unknown date, unspecified number of patients received an improperly stored dose of VARIVAX injection, subcutaneous route, (lot # M025865, expiration date: 24-MAY-2018), (lot # M008173, expiration date: 16-FEB-2018), (lot # M025869, expiration date: 24-MAY-2018), (lot # 024680, expiration date: 18-MAY-2018), (lot # M031969, expiration date: 30-JUN-2018) (strength and dose was not reported). The patient's concomitant medications were not reported. The temperature excursion with VARIVAX was 2 hours and 34 minutes (154 minutes) at 15.8 Fahrenheit degrees. The temperature excursions were detected by a data logger. No adverse effects were reported and no product quality complain was involved. Lot number M025869 has been verified to be a valid lot number for varicella virus vaccine live (Oka/Merck). Lot number 024680 is an invalid lot number for varicella virus vaccine live (Oka/Merck). Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a vaccine coordinator refers to unspecified patients of unknown age and gender. The concurrent conditions, drug reactions/allergies and medical history of the patients were not reported. On unknown dates, the patients were vaccinated with a dose of improperly stored ROTATEQ with lot number M007124 and expiration date of 05-OCT-2017, orally (strength and dose were not reported), which was stored at 47.5 Fahrenheit degrees for 1 hour and 32.9 Fahrenheit degrees for  hour. There was no previous temperature excursion. The temperature excursions were detected by a data logger. There were no concomitant therapies reported. No product quality complaint was involved. This is one of several cases form the same reporter. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash erythematous
Clinical narrative: Patient received vaccine on 11-17-16. She called pharmacy to report as rash dark red about size of 2 quarters. She was using hydrocortisone cream on it for itching. No other problems.
Age: 15.0
Sex: M
Vaccine: HPV4
Symptoms: Gastrointestinal disorder, Headache, Vomiting
Clinical narrative: Mother called in AM to report patient had vomited 5x. No fever, no discomfort just headache called back in the PM to learn patient was better and brother had headaches the previous week.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Body temperature increased, Feeling abnormal, Nausea, Paraesthesia
Clinical narrative: Woke up in middle of the night with 101 degree temp, nausea, tingling skin. That morning skin still felt weird. No reaction at site. TYLENOL did help.
Age: 11.0
Sex: U
Vaccine: HPV9
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a 12 year old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, reported as when the patient was 11 years old, the patient was vaccinated with a dose of GARDASIL intramuscularly (dose, route of administration, lot# and expiration date were not reported). On 13-NOV-2015, when the patient was 12 years old, the patient was vaccinated with GARDASIL 9 intramuscularly, lot # L028083, expiration date 03-JUL-2017 (dose and route of administration were not reported). No adverse effect was reported. Additional information has been requested.