chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 19.0
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 19-year-old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant medications was provided. On an unspecified date in July 2014, he patient was vaccinated with the first dose of GARDASIL injection (dose, route of administration, lot# and expiration date were not reported). Then, on an unspecified date in August 2014, the patient received the second dose of GARDASIL injection (dose, route of administration, lot#. and expiration date were not reported). On 26-JUN-2017 (reported as today), the patient was vaccinated with a dose of GARDASIL 9 (lot # N003703, expiration date: 29-OCT-2017; dose and route of administration were not reported). That was the third dose of the human papillomavirus vaccine received by the patient. No adverse effects were reported. No product quality complaint was involved. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Blister, Injection site erythema
Clinical narrative: This spontaneous report as received from a other health professional (Nurse) refers to a 5 year old female patient. On 22-JUN-2017 the patient was vaccinated with VARIVAX, subcutaneously for prophylaxis. (Lot # M045205, expiration date 11-NOV-2017). On the same day after onset of therapy the patient experienced injection site erythema and blister. The outcome of injection site erythema and blister was unknown. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Chills, Pyrexia, Rash
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant medication use were not provided.  On an unknown date the patient was vaccinated either with PNEUMOVAX 23, (lot#, route and indication for use were unknown) or PREVNAR, (lot#, route and indication for use were unknown). On an unknown date after receiving the vaccine, the patient experienced rash or her torso, chills and a fever. Laboratory data was unknown. It was unknown if any treatment was provided. The physician instructed the patient to obtain the vaccination record from the pharmacy to confirm the name of the vaccine that she received. The physician reported that as of 28-JUN-2017 the patient was in stable condition; however, the physician did not know the outcome of rash on her torso, fever and chills. It was unknown if the patient would continue to take the unknown vaccine. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: This spontaneous report was received from a physician via a company representative and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient was vaccinated with a dose of VARIVAX (frequency, route of administration, lot # and expiration date were not reported) for prophylaxis. On an unknown date (reported as after an unspecified period of time), the patient "developed a rash". The outcome of the event and the relatedness between the event and VARIVAX were not reported. Additional information is not expected since the physician's contact details were not provided.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 05-JUL-2017, the patient was vaccinated with improperly stored dose of PNEUMOVAX23 lot # N010105, expiration date 15-NOV-2018 (dose and route of administration were not reported) for prophylaxis. There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 9 Celsius degrees to 25 Celsius degrees for 5 days (120 hours). Data logger was not involved. There were no previous excursions reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates since April 2016, the patients were vaccinated with the improperly stored doses of M-M-R II (dose, route of administration, lot # and expiration date were not reported) for prophylaxis. No adverse effects were reported. The digital logger was involved. M-M-R II also underwent previous temperature excursion. This is one of two reports received from the same source. Additional information has been requested.; Sender's Comments:  US-009507513-1707USA003831:
Sex: F
Vaccine: VARCEL
Symptoms: Rash, Rash vesicular
Clinical narrative: This spontaneous report has been received from a pharmacist concerning a 32 year old female patient. The patient's medical history, drug allergies, concurrent conditions and concomitant therapies were not reported. On 05-JUN-2017, the patient was vaccinated with the first dose of VARIVAX with lot number M009766 and expiration date on 23-FEB-2018 (dose, route of administration and anatomical location were not provided) for prophylaxis. On approximately 12-JUN-2017 (reported as "1 week later"), the patient experienced a rash on both arms and neck, "little spots like chicken pox." (rash vesicular). At the time of reporting, the patient had recovered from the rash vesicular. It was reported that the rash lasted for two weeks, and no treatment was provided. The causal relationship between VARIVAX and the event was unknown.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a nurse, concerning a male patient of an unknown age.  The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medication were not reported. On 06-JUL-2017, the patient was vaccinated with an unspecified expired dose of GARDASIL 9 lot number: L044475 with expiration date of 12-MAY-2017 (dose, dose number, anatomical location and route of administration were not provided) for prophylaxis. No adverse effects were reported.
Sex: U
Vaccine: PPV
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. On 22-JUN-2017 the patient was vaccinated with PNEUMOVAX 23 for prophylaxis. On JUN-2017 the patient experienced pyrexia and pain in extremity. The outcome of pain in extremity and pyrexia is unknown. The causality assessment was not provided. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history, concurrent conditions or concomitant medications were not reported. On an unknown date between 15-JUN-2017 and 06-JUL-2017, the patients received unspecified doses of PNEUMOVAX 23 (lot# N005096, expiration date: 22-OCT-2018 and lot# N004564, expiration date: 22-OCT-2018) (dose, frequency and route of administration were unspecified) for prophylaxis, in immunization series that were improperly stored. No adverse events were reported. It was stated that the vaccines were exposed to a temperature of 1 Celsius degree for a time frame of 65 hours and 5 minutes. There were no previous temperature excursions and a digital data logger was involved. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1707USA003300: US-009507513-1707USA003301: US-009507513-1707USA003302: US-009507513-1707USA003303: US-009507513-1707USA003298: US-009507513-1707USA003299.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of an unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 07-JUL-2017, the patient was vaccinated with an expired dose of RECOMBIVAX HB injection, lot # K024553, expiration date 15-APR-2017 (dose, route and site of administration were not reported) for prophylaxis. The administered dose of vaccine also underwent a temperature excursion (no details provided). No adverse effects were reported. No additional information was provided. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a certified medical assistant who referred a currently 1-year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX (dose and route of administration were not reported) lot # N000682, date of expiration: 06-JAN-2019, for prophylaxis. There was no adverse effects reported. VARIVAX was stored between -14 Celsius degrees (C) and 10 C for 2.5 hours and between -9 C and 8 C for 3.5 hours. There was no previous temperature excursion. The digital data logger was involved in recording the excursion. 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 other health professional refers to a patient of unknown age. On an unknown date the patient was vaccinated with PROQUAD for prophylaxis. Other suspect therapies included VARIVAX. On an unknown date the patient experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage to be not related to PROQUAD and VARIVAX. The reporter considered no adverse event to be not related to VARIVAX and PROQUAD. Additional information is not expected.
Sex: M
Vaccine: MMR
Symptoms: Incorrect dose administered, No adverse event, Syringe issue
Clinical narrative: This spontaneous report was received from a registered nurse referring to a male patient of unknown age. The patient's medical history or concurrent conditions were not reported. On 06-JUL-2017, the patient was vaccinated with "less than complete dose" of M-M-R II for prophylaxis, which had the lot number reported as N001532, expiration date 13-JAN-2019, (dosage information and route were not reported), due to syringe leakage. Information regarding concomitant medication was not provided. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to multiple patients of unknown age and gender. The patients' concomitant medications, concurrent conditions and medical histories were not provided. On unknown dates, the patients were administered doses of improperly stored PROQUAD injection, lot # M022400 with expiration date on 01-NOV-2017, lot # M038861 with expiration date on 13-MAR-2018 and lot # M044718 with expiration date on 07-MAY-2018 (doses and routes of administration were not reported). The administered doses of PROQUAD were reconstituted with sterile diluent (manufacturer unknown) (lot # and expiration date were reported as unknown). Administered doses of vaccines experienced a temperature excursion from -9 degrees Celsius to 8 degrees Celsius, which lasted for 3.5 hours. No previous temperature excursion was reported. A digital data logger was involved in recording the excursion. No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1707USA002924.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information was received from a nurse concerning a patient of unknown age and gender. No information was received regarding the patient's medical history, concurrent conditions or concomitant medications. On 26-JUN-2017 the patient was administered a dose of M-M-R II (lot number, dosage, and route of administration unknown). It was reported that the M-M-R II expired on 25-JUN-2017. No adverse events were reported. No additional information was provided. Outcome of event was unknown. Additional information has been requested.
Sex: U
Vaccine: HIBV, HPV9, MMR, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information was received on 29-JUN-2017 from a registered nurse regarding multiple unspecified patients. Medical history, concurrent conditions and concomitant medications were not reported. On unspecified dates from 27-MAY-2017 to 01JUN-2017 the patients were administered improperly stored doses of GARDASIL 9 (lot # M036059, expiration date 03-JUN-2020) dose not provided); M-M-R II (lot # M007279, expiration date 09-FEB-2018 and M032487, expiration date 05-JUL-2018) dose not provided); PEDVAXHIB (lot # M034188, expiration date 20-MAY-2019 and N000235, expiration 26-OCT-2019) (dose not provided); and ROTATEQ (lot # M040268, expiration date 14-MAY-2018) (dose not provided). Temperature: 47 degrees Fahrenheit to 77 degrees Fahrenheit Timeframe: 48 hours Previous temp excursion: No Was call because of a data logger: No. No adverse effects were reported. The outcome of the event was not reported and the causality. No further information was provided. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to an unspecified number of patients of an unknown refers to a patient of unknown age. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD lot # M041082 with an expiration date 04-APR-2018, lot# M042502 with an expiration date 17-APR-2018, lot# M046943 with an expiration date 27-MAY-2018 for prophylaxis (route of administration and anatomical location were not reported). No adverse effects were reported. The nurse confirmed that sterile diluent used for reconstitution of vaccine was stored at recommended temperature range. Administered doses of PROQUAD experienced the temperature excursion from 6 degrees Fahrenheit to 14 degrees Fahrenheit for 2 hours and 20 minutes. There was previous temperature excursion (no details were reported). A digital data logger was involved. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a registered nurse concerning a patient of unknown age and gender. The patient's concomitant therapy, medical history and drug reaction were not provided. On 30-JUN-2017 the patient received a dose of expired GARDASIL (dose and route unknown, lot # L040459, expiration date 06-APR-2017) for prophylaxis. No adverse effects were reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to multiple patients of unknown age and gender. The patients' concomitant medications, concurrent conditions and medical histories were not provided. On unknown dates, the patients were administered doses of improperly stored VARIVAX injection, lot # M039316 with expiration date on 20-SEP-2018 (doses and routes of administration were not reported). The administered doses of VARIVAX were reconstituted with sterile diluent (manufacturer unknown) (lot # and expiration date were reported as unknown). Administered doses of vaccines experienced a temperature excursion from -9 degrees Celsius to 8 degrees Celsius, which lasted for 3.5 hours. No previous temperature excursion was reported. A digital data logger was involved in recording the excursion. No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1707USA002377.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a Registered Nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions and concomitant medications were not provided. On 17-JAN-2011, the patient received the first dose of GARDASIL 9 (strength, dose, route of administration, Lot # and expiration date were not reported) for prophylaxis and on 04-APR-2011, received the second dose of GARDASIL 9 (strength, dose, route of administration, Lot # and expiration date were not reported) for prophylaxis, which was administered late. The Nurse also stated that on 06-JUL-2017, wanted to administer the third dose of GARDASIL 9, however, this dose was not administered yet. No adverse effects were reported.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history, concurrent conditions or concomitant medications were not reported. On an unknown date between 15-JUN-2017 and 06-JUL-2017, the patients received unspecified doses of VAQTA lot # M039202, expiration date: 11-MAR-2018 (dose, frequency and route of administration were unspecified) for prophylaxis, in immunization series that were improperly stored. No adverse events were reported. It was stated that the vaccines were exposed to a temperature of 1 Celsius degree for a time frame of 65 hours and 5 minutes. There were no previous temperature excursions and a digital data logger was involved. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1707USA003299: US-009507513-1707USA003300: US-009507513-1707USA003301: US-009507513-1707USA003302: US-009507513-1707USA003303: US-009507513-1707USA002262.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history, concurrent conditions or concomitant medications were not reported. On an unknown date between 15-JUN-2017 and 06-JUL-2017, the patients received unspecified doses of LIQUID PEDVAXHIB (lot# M014925, expiration date: 16-FEB-2019; lot#: N000238, expiration date: 25-OCT-2019; lot#: M036057, expiration date: 18-MAY-2019)(dose, frequency and route of administration were unspecified) for prophylaxis, in immunization series that were improperly stored. No adverse events were reported. It was stated that the vaccines were exposed to a temperature of 1 Celsius degree for a time frame of 65 hours and 5 minutes. There were no previous temperature excursions and a digital data logger was involved. This is one of several reports from the same reporter.; Sender's Comments: US-009507513-1707USA003300: US-009507513-1707USA003301: US-009507513-1707USA003302: US-009507513-1707USA003303: US-009507513-1707USA003298: US-009507513-1707USA002262:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history, concurrent conditions or concomitant medications were not reported. On an unknown date between 15-JUN-2017 and 06-JUL-2017, the patients received unspecified doses of ROTATEQ (lot#: M044395, expiration date: 31-MAY-2018; lot#: M038744, expiration date: 26-APR-2018; lot# reported as: M041415, expiration date: 28-AUG-2018) (dose, frequency and route of administration were unspecified) for prophylaxis, in immunization series that were improperly stored. No adverse events were reported. It was stated that the vaccines were exposed to a temperature of 1 Celsius degree for a time frame of 65 hours and 5 minutes. There were no previous temperature excursions and a digital data logger was involved. This is one of several reports from the same reporter.; Sender's Comments: US-009507513-1707USA002262: US-009507513-1707USA003301: US-009507513-1707USA003302: US-009507513-1707USA003303: US-009507513-1707USA003298: US-009507513-1707USA003299:
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history, concurrent conditions or concomitant medications were not reported. On an unknown date between 15-JUN-2017 and 06-JUL-2017, the patients received unspecified doses of PROQUAD (lot#: M031567; expiration date: 24-DEC-2017; lot#: M031565; expiration date: 24-DEC-2017; lot#: M006102; expiration date: 01-AUG-2017; lot#: M043306; expiration date: 24-APR-2018; lot#: M033612; expiration date: 14-JAN-2018) (dose, frequency and route of administration were unspecified) for prophylaxis, in immunization series that were improperly stored. No adverse events were reported. It was stated that the vaccines were exposed to a temperature of 1 Celsius degree for a time frame of 65 hours and 5 minutes. There were no previous temperature excursions and a digital data logger was involved. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1707USA003300: US-009507513-1707USA002262: US-009507513-1707USA003302: US-009507513-1707USA003303: US-009507513-1707USA003298: US-009507513-1707USA003299.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history, concurrent conditions or concomitant medications were not reported. On an unknown date between 15-JUN-2017 and 06-JUL-2017, the patients received unspecified doses of VARIVAX (lot#: L037565, expiration date: 29-SEP-2017; lot#: M042858, expiration date: 21-OCT-2018; lot#: M019643, expiration date: 20-APR-2018; lot#: M042858, expiration date: 21-OCT-2018) (dose, frequency and route of administration were unspecified) for prophylaxis, in immunization series that were improperly stored. No adverse events were reported. It was stated that the vaccines were exposed to a temperature of 1 Celsius degree for a time frame of 65 hours and 5 minutes. There were no previous temperature excursions and a digital data logger was involved. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1707USA003300: US-009507513-1707USA003301: US-009507513-1707USA002262: US-009507513-1707USA003303: US-009507513-1707USA003298: US-009507513-1707USA003299.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history, concurrent conditions or concomitant medications were not reported. On an unknown date between 15-JUN-2017 and 06-JUL-2017, the patients received unspecified doses of ZOSTAVAX (lot#: M041085, expiration date: 03-JAN-2018; lot#: M044220, expiration date: M044220) (dose, frequency and route of administration were unspecified) for prophylaxis, in immunization series that were improperly stored. No adverse events were reported. It was stated that the vaccines were exposed to a temperature of 1 Celsius degree for a time frame of 65 hours and 5 minutes. There were no previous temperature excursions and a digital data logger was involved. This is one of several reports from the same reporter.; Sender's Comments: US-009507513-1707USA003300: US-009507513-1707USA003301: US-009507513-1707USA003302: US-009507513-1707USA002262: US-009507513-1707USA003298: US-009507513-1707USA003299:
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse via a company representative refers to an unspecified adult patient of an unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 26-JUN-2017 the patient was vaccinated with a separate doses of VARIVAX, subcutaneous (dose, frequency unknown) (lot number N014366, expiry date May 2019) to prevent chickenpox. On an unknown date in 2017 the patient received a dose of VARIVAX, subcutaneous (dose, frequency unknown) to prevent chickenpox. It was reported that both the vaccines were given out of temperature range inadvertently. The action taken and outcome of the event was unknown. No further information provided. This case is linked to case number 1707USA000191 via same reporter link. Additional information has been requested. Sender's Comments: US-009507513-1707USA000191.
Age: 34.0
Sex: F
Vaccine: PNC13
Symptoms: Cyst, Injection site cyst, Injection site pain, Injection site pustule, Pain
Clinical narrative: This is a spontaneous report from a contactable physician. A 34-year-old female healthy patient of an unspecified ethnicity received PREVNAR 13, via an unspecified route of administration about a week ago before this report (in 2017) at single dose for immunization. Medical history and concomitant drug were unknown. Patient developed painful cysts or pustules filled with white stuff, almost like little acne.  It initially started at the injection site, and subsequently it moved to her chest, legs and arms. It was pretty painful. It was reported that the events started on the same day she received the vaccine (in 2017). The patient was in physician's office and she would like to know what it is and what she should do about them. Event outcome was unknown.
Age: 34.0
Sex: F
Vaccine: PNC13
Symptoms: Rash pustular
Clinical narrative: This is a spontaneous report from a contactable physician. A 34-year-old female healthy patient of an unspecified ethnicity received PREVNAR 13, via an unspecified route of administration about a week ago before this report (in 2017) at single dose for immunization. Medical history and concomitant drug were unknown. Patient developed painful cysts or pustules filled with white stuff, almost like little acne.  It initially started at the injection site, and subsequently it moved to her chest, legs and arms. It was pretty painful. It was reported that the events started on the same day she received the vaccine (in 2017). The patient was in physician's office and she would like to know what it is and what she should do about them. Event outcome was unknown.
Sex: F
Vaccine: PNC13
Symptoms: Peripheral swelling
Clinical narrative: This is a spontaneous report from a contactable pharmacist via a Pfizer sales representative. An 85 year-old female patient of an unspecified race and ethnicity received PREVNAR 13 at single dose via an unspecified route of administration on an unspecified date for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced swollen arm for 10 days after the vaccination. Outcome was recovered.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Computerised tomogram normal, Electroencephalogram normal, Nuclear magnetic resonance imaging normal, Seizure like phenomena, Vomiting
Clinical narrative: Mom took patient to the ER due to vomiting and seizure like activity. He was afebrile through is admission. He was admitted to hospital service and a work up was done. He was discharged on 07/12/2017. He has been referred to neurology for further evaluation.
Age: 22.0
Sex: F
Vaccine: VARCEL
Symptoms: Fatigue, Migraine, Pruritus generalised, Vaccination site pruritus, Vaccination site rash
Clinical narrative: When waking up next morning after vaccination noticed rash at site of vaccination and small itchy bump on inner L forearm. As day progressed migraine headache developed and more itching bumps appeared on arms, torso, and legs. Fatigued began after vaccination on 07/14/17 and lasted through 07/15/17.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Blood pressure increased, Chills, Dizziness, Dry mouth, Dyspnoea
Clinical narrative: Within a few minutes of receiving the flu vaccine (mandatory by facility) I began to feel dizzy, lightheaded, extremely dry mouth, throat felt like it was tightening up, short of breath, and heart beating fast. I also was itching and had a rash all over. I was immediately taken to the emergency room. My blood pressure was elevated 150/104, heart rate 118, oxygen sat 100% on room air. I was given IV fluids, steroid, ZANTAC, and an antihistamine while in the ED. I developed chills as well. I was discharged home on steroids and BENADRYL. I had to follow up at facility due to being work related.  I continued to have breathing problems for at least 2 to 3 weeks after reaction.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Heart rate increased, Pruritus, Rash generalised, Throat tightness
Clinical narrative: Within a few minutes of receiving the flu vaccine (mandatory by facility) I began to feel dizzy, lightheaded, extremely dry mouth, throat felt like it was tightening up, short of breath, and heart beating fast. I also was itching and had a rash all over. I was immediately taken to the emergency room. My blood pressure was elevated 150/104, heart rate 118, oxygen sat 100% on room air. I was given IV fluids, steroid, ZANTAC, and an antihistamine while in the ED. I developed chills as well. I was discharged home on steroids and BENADRYL. I had to follow up at facility due to being work related.  I continued to have breathing problems for at least 2 to 3 weeks after reaction.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a pharmacist referring to unknown multiple patients of unknown age and gender. The patients' medical history, concurrent conditions, drug and allergy history were not reported. On an unknown date, the patients received improperly stored doses of VARIVAX lot # M023382 with expiration date on 11-MAY-2018 and lot # M025864 with expiration date on 24-MAY-2018, (dose and route were not provided) for prophylaxis. It was reported that the vaccines were reconstituted with sterile diluent (MRK INJ) which was not involved in a temperature excursion. On an unspecified day, the data logger registered that during 14 hours, 30 minutes the temperature under the vaccine was stored, was -14° Celsius (°C) to -10°C (-10, 6°C), there was no prior temperature excursion and no adverse events were reported. This is one of the two reports received from the same source. Sender's Comments: US-009507513-1706USA009407.
Age: 1.0
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This information has been received from a licensed practical nurse concerning a 12 month old patient of unknown gender. The patient's medical history, drug allergies, concurrent conditions and concomitant therapies were not reported. The nurse stated that on 22-JUN-2017, the patient was vaccinated with a dose of PNEUMOVAX 23 with lot number N001007 and expiration date on 19-SEP-2018 (dose, dose number, route of administration and anatomical location were not provided) administered for prophylaxis. The nurse stated that the physician ordered PNEUMOVAX 23 instead of PREVNAR 13 for this patient. The nurse confirmed that this event was a result of human error, not product confusion. No adverse effects were reported.
Sex: U
Vaccine: MMRV
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 gender. The patients' current condition and medical history were not provided. On an unknown dates, the patients were vaccinated with PROQUAD dose and route of administration were not reported (lot # M006107, date of expiration 01-AUG-2017). The PROQUAD was reconstituted with properly stored sterile diluent (manufacturer unknown). No adverse effects were reported. PROQUAD was stored between 15 Fahrenheit degrees (F) and 46 F for 2 hours and 12 minutes. There was previous temperature excursion temperatures between 15 F and 46 F for 1 hour and 12 minutes. The digital data logger was involved in recording the excursion. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1706USA011404.
Sex: U
Vaccine: HPV4
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from an office manager referring to a patient of unknown age and gender. On 05-JUL-2017, the patient was vaccinated with a dose of GARDASIL lot # M014929 expiration date: 27-MAY-2017 for prophylaxis. On 05-JUL-2017, the patient experienced expired product administered. On an unknown date the patient experienced no adverse event. The outcome of expired product administered and no adverse event was unknown. The reporter considered expired product administered and no adverse event to be not related to GARDASIL.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP, HPV9
Symptoms: Pigmentation disorder
Clinical narrative: This spontaneous report was received from a reporter (role unspecified) via a company representative and refers to a female patient of an unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 26-MAY-2017, the patient was vaccinated with the first dose of GARDASIL 9 injection (route and site of administration, dose, lot number and expiration date were not reported) for prophylaxis. On approximately 02-JUN-2017 (reported as about a week after the injection), the patient experienced pigmentation of the skin for an unspecified reason. The outcome of pigmentation of the skin and the relatedness between the event and GARDASIL 9 were not reported. At the time of reporting no additional adverse event information was available. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP, HPV9
Symptoms: Skin hyperpigmentation
Clinical narrative: This spontaneous report was received from a reporter (role unspecified) via a company representative and refers to a female patient of an unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 26-MAY-2017, the patient was vaccinated with the first dose of GARDASIL 9 injection (route and site of administration, dose, lot number and expiration date were not reported) for prophylaxis. On approximately 02-JUN-2017 (reported as about a week after the injection), the patient experienced pigmentation of the skin for an unspecified reason. The outcome of pigmentation of the skin and the relatedness between the event and GARDASIL 9 were not reported. At the time of reporting no additional adverse event information was available. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse who referred to multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On an unknown dates, the patients were vaccinated with an improperly stored dose of VARIVAX, dose and route of administration were not reported (lot # M041080 with expiration date 06-OCT-2018). No adverse effects were reported. VARIVAX was stored between -14 Celsius degrees (C) and 10 C for 132 hours. There was no previous temperature excursion reported. The digital data logger was involved in recording the excursion. This is one of two reports received from the same reporter. Additional information is not expected as there was no consent for follow up. Sender's Comments: US-009507513-1707USA002941.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a 15 year old patient. On 06-JUL-2017 the patient was vaccinated with GARDASIL dose 2 for prophylaxis. On 06-JUL-2017 the patient experienced inappropriate schedule of drug administration. On an unknown date the patient experienced no adverse event. The outcome of inappropriate schedule of drug administration and no adverse event is unknown. The reporter considered inappropriate schedule of drug administration and no adverse event to be not related to GARDASIL. Additional information is not expected.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse who referred to multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On an unknown dates, the patients were vaccinated with an improperly stored dose of VAQTA, dose and route of administration were not reported (lot # was reported as M038728, expiration date was not reported). No adverse effects were reported. VAQTA was stored between 0 Celsius degrees (C) and 1 C for 80 hours. There was previous temperature excursion between 0 C and 1 C for 41,5 hours. The digital data logger was involved in recording the excursion. This is one of two reports received from the same reporter. Additional information is not expected as there was no consent for follow up. Sender's Comments: US-009507513-1707USA002350.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Redness, itching, swelling at injection site.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse, referring to an unknown number of unspecified patients. The patients' medical history, concurrent conditions, drug and allergy history were not provided. It was reported that since 12-MAY-2017, the patients had been vaccinated with improperly stored doses of VARIVAX (dose, frequency and administration route were not reported) for prophylaxis. The lot numbers and expiration date of the administered vaccines were respectively: M033906; 20-MAR-2018, M045204; 11-NOV-2018, M038225; 07-SEP-2018. On an unspecified date in 2017, the vaccines were exposure to a temperature excursion; the data logger registered a temperature range between 6° Fahrenheit (F) and 14°F during a time frame of 18 minutes. The previous temperature excursion registered was 15°F to 46°F for 21 minutes. The registered nurse mentioned that a properly stored sterile water diluent (manufacturer unknown) (lot number and expiration date were not provided) was used to reconstitute the doses of VARIVAX. No adverse effects were reported. The reporter stated that the vaccines would be supported until labeled expiry. This is one of two cases from the same reporter. Sender's Comments: US-009507513-1707USA001006.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse, referring to an unknown number of unspecified patients. The patients' medical history, concomitant therapy, drug and allergy history were not provided. It was reported that since 12-MAY-2017, the patients had been vaccinated with improperly stored doses of PROQUAD (dose, frequency and administration route were not reported) for prophylaxis. The lot numbers and expiration date of the administered vaccines were respectively: M010477; 01-SEP-2017; M031568; 27-DEC-2017; M035143; 30-JAN-2017; M038228; 06-MAR-2018. On an unspecified date in 2017, the vaccines were exposure to a temperature excursion; the data logger registered a temperature range between 6° Fahrenheit (F) and 14°F during a time frame of 18 minutes. The previous temperature excursion registered was 15°F to 46°F for 21 minutes. The registered nurse mentioned that a properly stored sterile water diluent (manufacturer unknown) (lot number and expiration date were not provided) was used to reconstitute the doses of PROQUAD. No adverse effects were reported. The reporter stated that the vaccines would be supported until labeled expiry. This is one of two cases from the same reporter. Sender's Comments: US-009507513-1706USA008980.
Sex: U
Vaccine: PPV
Symptoms: Adverse reaction
Clinical narrative: This spontaneous report was received from a pharmacist via a company representative and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 22-JUN-2017, the patient was vaccinated with a dose of PNEUMOVAX 23 (dose, route of administration, lot # and expiration date were not reported). On an unknown date in June 2017, the patient experienced an unspecified reaction for an unspecified reason. The outcome of the event was unknown. The relatedness between the event and PNEUMOVAX 23 was not reported. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a medical assistant concerning a male patient of unknown age. On 05-JUN-2017, the patient received an improperly stored dose of VARIVAX, lot # M046004, expiration date 18-NOV-2018, (route of administration not provided). The sterile diluent used to reconstitute the VARIVAX was properly stored. No information was received regarding the patient's past medical history, concurrent conditions, or other concomitant medication. No adverse effect reported. Temperature was reported as: 6°F to 14°F (10.8°F), Time frame: 1 hour, 18 minutes, Previous temperature excursion: No, Data logger involved: Yes. No further information was provided. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: FLUX
Symptoms: Guillain-Barre syndrome
Clinical narrative: Initial unsolicited report received from healthcare professional via other company (Pfizer) (manufacturer control number: 2017250412) on 05-Jul-2017. This case involves a male patient (age not reported) who was vaccinated with a dose of INFLUENZA VACCINE (Influenza Virus Vaccine) (Batch number, expiration date, dose, route and site of administration was not reported) on an unspecified date in Oct 2016. The patient's medical history and concomitant medications were not reported.  On an unspecified date, following the vaccination, the patient experienced GBS (Guillain Barre Syndrome). Lab data and corrective treatment were not reported. Outcome of event was not reported.  Upon internal review, the company decided to consider the event serious because of important medical event developed gbs (Guillain Barre Syndrome). List of documents held by sender: none.; Sender's Comments: The patient experienced guillain barre syndrome post vaccination with influenza vaccine (MFR UNK). Time to onset was not reported. No information regarding patients tolerance to past vaccinations or concurrent medical conditions was reported. Investigations ruling out alternate etiologies should be performed and information regarding product name dose and manufaturer should be obtained. Based on available information the role of the vaccine can not be assessed.
Age: 14.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Syncope
Clinical narrative: Patient fainted after vaccine administration, duration of 8-10 seconds. Patient was placed in supine position with legs elevated for 15 minutes and ice pack placed behind neck area. Patient was able to ambulate without assistant after incident.
Age: 15.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Dizziness, Flushing, Nausea
Clinical narrative: PT BEGAN FEELING LIGHTHEADED AND NAUSEATED, PT WAS VERY FLUSHED FROM 0907 TO 0920.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Urticaria
Clinical narrative: Developed diffuse uticarial rash 6 days after vaccines given.  No s/s of anaphylaxis.
Age: 0.0
Sex: F
Vaccine: HEP
Symptoms: Condition aggravated, Eczema
Clinical narrative: Severe eczema occurred upon vaccination. Treated by pediatrician by the second month as "heat rash" despite lack of heat in April. Treated in later months by same pediatrician as "eczema" whereupon steroidal topical medication was prescribed.
Age: 35.0
Sex: F
Vaccine: VARCEL
Symptoms: Arthralgia, Erythema, Injection site erythema, Injection site mass, Injection site pain
Clinical narrative: On the first day, in the night, the injection area was sore and red. On the second day, there was a baseball size red area around the injection site that was swollen and warm with a hard lump under he skin. By the afternoon, my whole body and joints were painful and I had a fever of 102 even after taking ibuprofen. On the third day, the redness and swelling had spread up to my armpit and down past my elbow. It was painful like a bruise and hot like a sunburn. I talked to a medical professional and was prescribed an antibiotic. Also took ibuprofen and benadryl and iced the area. By the fourth day the redness had still spread and swelling continued. By the 5th day (today) the redness and swelling and warmth and pain had finally started to reverse.
Age: 35.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site swelling, Injection site warmth, Pain, Pyrexia, Skin warm
Clinical narrative: On the first day, in the night, the injection area was sore and red. On the second day, there was a baseball size red area around the injection site that was swollen and warm with a hard lump under he skin. By the afternoon, my whole body and joints were painful and I had a fever of 102 even after taking ibuprofen. On the third day, the redness and swelling had spread up to my armpit and down past my elbow. It was painful like a bruise and hot like a sunburn. I talked to a medical professional and was prescribed an antibiotic. Also took ibuprofen and benadryl and iced the area. By the fourth day the redness had still spread and swelling continued. By the 5th day (today) the redness and swelling and warmth and pain had finally started to reverse.
Age: 35.0
Sex: F
Vaccine: VARCEL
Symptoms: Swelling
Clinical narrative: On the first day, in the night, the injection area was sore and red. On the second day, there was a baseball size red area around the injection site that was swollen and warm with a hard lump under he skin. By the afternoon, my whole body and joints were painful and I had a fever of 102 even after taking ibuprofen. On the third day, the redness and swelling had spread up to my armpit and down past my elbow. It was painful like a bruise and hot like a sunburn. I talked to a medical professional and was prescribed an antibiotic. Also took ibuprofen and benadryl and iced the area. By the fourth day the redness had still spread and swelling continued. By the 5th day (today) the redness and swelling and warmth and pain had finally started to reverse.