chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 16.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Urinary tract infection
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA (Food and Drug Administration) under the Freedom of Information Act (FOI) (Agency # 681137) refers to a 16 years old female patient. There was no medical history and other medications. The patient's current illness was unknown. On 12-JUL-2016 the patient was vaccinated with 3rd dose of GARDASIL 9 1 dose unit, route of administration: needle and syringe (not specified further) in the right arm (lot # and expiry date was not reported) for prophylaxis. No concomitant medications were reported. On 12-JAN-2017, the patient experienced abdominal pain, persistent urinary tract infections, ovarian cyst, yeast infection, fatigue and endometrial thickening. The outcome of the events was reported as not recovered/not resolved. The agency did not provide the causality assessment for the event. Additional information is not expected since no further information can be obtained from the regulatory authority.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV9, MNQ, TDAP, HEPA, HPV9, MNQ, TDAP
Symptoms: Erythema, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA (Food and Drug Administration) under the Freedom of Information Act (FOI) (Agency # 681365) refers to a 12 years old female patient. There was no current illness. The patient's medical history, drug allergies and concomitant medications were not reported. On 09-JAN-2017 the patient was vaccinated with GARDASIL 9 (lot # M028323, expiry date not reported) 1 Dose unit, intramuscular in the left arm for prophylaxis. Other suspect therapies included MENVEO (Batch # M16003, expiry date not reported), BOOSTRIX (Batch # 9Z525, expiry date not reported) and HAVRIX (Batch # 9T53T, expiry date not reported). On 09-JAN-2017, the patient developed left arm redness, swelling, itching, hot to touch (L 18.5 ins x W 16 ins). There was no lab data. The outcome of the events was unknown. The agency did not provide the causality assessment for the events. Additional information is not expected since no further information can be obtained from the regulatory authority.
Age: 24.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Face injury, Lip injury, Syncope
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA (Food and Drug Administration) under the Freedom of Information Act (FOI) (Agency # 681527) refers to a 24 years old female patient. The patient's historical medication included sulfa. There was no current illness. On an unknown date the patient was vaccinated with first dose of GARDASIL 9 (lot # M036059, expiry date not reported) 1 dose unit, route of administration: unknown in the left arm for prophylaxis. No concomitant medications were reported. On an unknown date the patient walking to bathroom and fainted impacting (Left) cheek and chin and lower lip. At the reporting time the outcome of the events was reported as recovered/resolved. The agency did not provide the causality assessment for the events. Additional information is not expected since no further information can be obtained from the regulatory authority.
Age: 22.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Dizziness, Pallor
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act referring to a 22-year-old male patient. The patient had no medical history and no concurrent illnesses. On 07-FEB-2017, the patient was vaccinated with the first dose of GARDASIL 9 lot # M031557 dose 1, intramuscularly in the left arm for prophylaxis. On 07-FEB-2017, the patient arrived at check window, he was pale in color and felt faint. The patient lowered to floor. Vital signs were within normal limits. The patient was monitored until he felt better. On an unknown date, the patient recovered from the events. The relatedness between the events and GARDASIL 9 was not provided. Additional information is not expected as no further information can be obtained from the local regulatory authority.
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Joint range of motion decreased, Oedema, Tenderness, Vaccination complication
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA (HA# 683035) under the Freedom of Information Act referring to a 10 year old female patient. The patient's medical history, concurrent conditions and concomitant medications were not provided. On an unknown date, the patient was vaccinated with a first dose of GARDASIL 9 in the left arm, route of administration was reported as unknown (lot # M036059, expiration date was not provided), for prophylaxis. On an unspecified date, the patient developed tenderness, edema, joint range of motion decreased and vaccine related adverse effect. The outcome of the events was reported as recovered. The causality relationship between the events and GARDASIL 9 was not provided by the reporter. Additional information is not expected as no further information can be obtained from the local regulatory authority.
Age: 1.0
Sex: F
Vaccine: HIBV, MMR, PNC13, VARCEL
Symptoms: Crying, Culture, Full blood count, Injection site erythema, Injection site induration
Clinical narrative: The nurse gave my daughter a injection in her outer right thigh intramuscular of Hib-Prp-omp on 5/8/17 at 11:00am. She put gloves on but did not wash her hands. The next morning at 5:30am my daughter had a fever of 102.4, and that one injection site turned bright red overnight (she woke up at 5:30am crying) I took a pen and outlined the redness to monitor the site. Also the site was swollen, raised and hard. I called the nurse at the clinic that morning at 7:30am, left a message and the nurse who administered the shot had the appointment desk call me back to notify me that this was a normal reaction, I insisted on speaking to the nurse directly as I felt is was not normal (I have two other children and have not seen this kind of reaction with them) nurse insisted it was normal, I told her I would feel better if the Doctor and nurses looked at it and felt it. She agreed and I took my daughter in so they could look at the site and feel it. Two nurses and a Doctor looked at my daughters swollen, red, hot, raised hard injection site on her right thigh) they all said it was Normal. But to follow up if she had a high fever, she got worse, the site opened up into pus on 5/14/17 6:00pm during her bath, I rushed her to the ER, They did blood work, and told us the CBC was not elevated and to follow up with the pediatrician on 5/15/17 am, I called in the morning 7:30am to get in for appointment, they got us in at 9:30am with the doctor who was able to squeeze out a large amount of pus.
Age: 1.0
Sex: F
Vaccine: HIBV, MMR, PNC13, VARCEL
Symptoms: Injection site reaction, Injection site swelling, Injection site warmth, Purulent discharge, Pyrexia
Clinical narrative: The nurse gave my daughter a injection in her outer right thigh intramuscular of Hib-Prp-omp on 5/8/17 at 11:00am. She put gloves on but did not wash her hands. The next morning at 5:30am my daughter had a fever of 102.4, and that one injection site turned bright red overnight (she woke up at 5:30am crying) I took a pen and outlined the redness to monitor the site. Also the site was swollen, raised and hard. I called the nurse at the clinic that morning at 7:30am, left a message and the nurse who administered the shot had the appointment desk call me back to notify me that this was a normal reaction, I insisted on speaking to the nurse directly as I felt is was not normal (I have two other children and have not seen this kind of reaction with them) nurse insisted it was normal, I told her I would feel better if the Doctor and nurses looked at it and felt it. She agreed and I took my daughter in so they could look at the site and feel it. Two nurses and a Doctor looked at my daughters swollen, red, hot, raised hard injection site on her right thigh) they all said it was Normal. But to follow up if she had a high fever, she got worse, the site opened up into pus on 5/14/17 6:00pm during her bath, I rushed her to the ER, They did blood work, and told us the CBC was not elevated and to follow up with the pediatrician on 5/15/17 am, I called in the morning 7:30am to get in for appointment, they got us in at 9:30am with the doctor who was able to squeeze out a large amount of pus.
Age: 0.17
Sex: M
Vaccine: DTAP, HEP, IPV, MMR, RVX
Symptoms: Pyrexia, White blood cell count normal
Clinical narrative: 102.6 fever (rectal temp) TYLENOL given.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to multiple unspecified patients of unknown age and gender. On 12-JUL-2016, the patient was vaccinated with improperly stored doses of GARDASIL 9 (lot # K026246 with 28-JAN-2017 and L017407 with 15-AUG-2017)  for prophylaxis after a reported temperature excursion on the same day. The time frame was 1.7 degrees Celsius for 2 hours. It was back in range. The vaccines previously were exposed to 1.9 degrees Celsius for 30 minutes, for a cumulative time out of range of 2 hours and 30 minutes. There were no adverse effects reported. No product quality complaint was involved. This is one of two reports from the same repUorter. Additional information has been requested.; Sender's Comments: S-009507513-1705USA008833:
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from an office manager and refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' concurrent conditions, pertinent medical history, drug reaction, allergies and concomitant therapies was reported. On unknown dates, the patients received improperly stored doses of VAQTA (doses and routes of administration were not provided) lot # M036459, expiration date: 18-JAN-2018 and lot # M047658, expiration date: 28-AUG-2017. No adverse effects were reported. The vaccines were stored for 2 hours and 30 minutes in the temperature between 9 and 25 degrees Celsius. There were no previous temperature excursions. Digital Data Logger was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA013230: US-009507513-1704USA013231: US-009507513-1704USA013229: US-009507513-1704USA013737.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from an office manager and refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' concurrent conditions, medical history and concomitant therapies was reported. On unknown dates, the patients received improperly stored doses of RECOMBIVAX HB (dose and route of administration were not provided) lot # M037248, expiration date: 21-FEB-2019. No adverse effects were reported. The vaccines were stored for 2 hours and 30 minutes in the temperature between 9 and 25 degrees Celsius. There were no previous temperature excursions. Digital Data Logger was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA013230: US-009507513-1704USA013231: US-009507513-1704USA012451: US-009507513-1704USA013737.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from an office manager and refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' concurrent conditions, pertinent medical history, drug reactions, allergies and concomitant therapies was reported. On unknown dates, the patients received improperly stored doses of ROTATEQ orally, lot # M040271, expiration date: 30-APR-2018 and lot # M035455, expiration date: 22-APR-2018. No adverse effects were reported. The vaccines were stored for 2 hours and 30 minutes in the temperature between 9 and 25 degrees Celsius. There were no previous temperature excursions. Digital Data Logger was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA012451: US-009507513-1704USA013231: US-009507513-1704USA013229: US-009507513-1704USA013737.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from an office manager and refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' concurrent conditions, pertinent medical history, drug reactions, allergies and concomitant therapies was reported. On unknown dates, the patients received improperly stored doses of VARIVAX (doses and routes of administration were not provided) lot # M039317, expiration date: 20-SEP-2018. The vaccines were reconstituted with sterile diluent (lot# and expiration date were not provided). No adverse effects were reported. The vaccines and the diluent were stored for 3 hours and 30 minutes in the temperature between -9 and 8 degrees Celsius. There were no previous temperature excursions. Digital Data Logger was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA013230: US-009507513-1704USA012451: US-009507513-1704USA013229: US-009507513-1704USA013737.
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 patients of unknown age and gender. No information about the patient's medical history, concurrent conditions or concomitant medications was provided. On unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD for prophylaxis, that underwent a temperature excursion of - 14 degrees Celsius to -10 degrees Celsius for a time frame of 18 hours and 17 minutes and the Digital data logger was involved. Concomitant therapies included sterile diluent. No adverse effects were reported and no product quality complaint was involved. This is one of two cases from the same reporter. Additional information is not expected as no consent for follow-up was provided. Sender's Comments:  US-009507513-1705USA008607.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, medical history, any known allergies or reactions or concomitant medications. On an unknown date, the patients were vaccinated with improperly stored GARDASIL 9 lot # M030380 with expiration date of 01-FEB-2019, lot# M032650 with expiration date of 31-MAR-2019, lot# M034780 with expiration date of 15-APR-2019, and lot# M037770 with expiration date of 01-JUN-2019, for prophylaxis (dose and route of administration were not reported). Administered doses of vaccines experienced the temperature excursion of 47-77 degrees Fahrenheit (°F) for 3 hours. There were not previous excursions. Data logger was involved. No adverse symptoms were reported. No product quality complaint was involved. No further information was provided. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1705USA001009: US-009507513-1705USA001228: US-009507513-1705USA001230: US-009507513-1705USA001231: US-009507513-1705USA001232.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, medical history, any known allergies or reactions or concomitant medications. On an unknown date, the patients were vaccinated with improperly stored PEDVAXHIB lot # M020100 with expiration date of 07-MAR-2019 and lot# M045206 with expiration date of 27-JUN-2019, for prophylaxis (dose and route of administration were not reported). Administered doses of vaccines experienced temperature excursion of 47-77 degrees Fahrenheit (°F) for 3 hours. There were not previous excursions. Data logger was involved.  No adverse symptoms were reported. No product quality complaint was involved. No further information was provided. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1705USA001228: US-009507513-1705USA001229: US-009507513-1705USA001230: US-009507513-1705USA001231.
Age: 0.17
Sex: U
Vaccine: HEP, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to a 9-week-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical histories provided. On 22-AUG-2016, the patient was vaccinated with improperly stored doses of RECOMBIVAX HB (lot # M000442, expiry date: 31-MAR-2018, dose and route of administration were not reported) and ROTATEQ (lot # L046319, expiration date: 28-SEP-2017, dose was not reported), orally. No symptoms were reported. Administered doses of vaccines experienced the temperature excursion of 32 degrees Fahrenheit for 15 minutes and 31 degrees Fahrenheit for 15 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1608USA012908: US-009507513-1608USA012794: US-009507513-1608USA012916.
Age: 16.0
Sex: U
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from an office manager and refers to a 16-year-old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 09-MAY-2017, the patient was vaccinated with PROQUAD (lot # M037652, expiration date: 28-FEB-2018, dose and route of administration were not reported) reconstituted with a sterile diluent (manufacturer unknown). No adverse effects were reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site cellulitis, Injection site pain, Injection site phlebitis, Injection site reaction, Skin tightness
Clinical narrative: This spontaneous report has been received from a nurse/administrator and referred to a 69-year-old female patient. The patient's relevant concurrent conditions included a drug/allergy to Iodine. She did not have any relevant historical conditions and concomitant therapies to be reported. On 10-MAY-2017, the patient was vaccinated with a dose of PNEUMOVAX 23 intramuscularly in her right upper arm (strength, dose, and frequency were not reported; lot number M022947 with an expiration date 11-NOV-2017) for prophylaxis. Then on 11-MAY-2017, the patient went to the nurse's office and she presented at the injection site phlebitis, cellulitis, tightness (almost bursting) and was extremely painful. On the same day, the patient was ordered for an ultrasound to rule out a deep vein thrombosis (DVT) (results not provided). The patient was started on therapy with clindamycin, BACTROBAN, BENADRYL, and PEPCID. At the time of this report, the outcome of cellulitis, phlebitis, muscle tightness and pain in extremity was unknown. The causality assessment between cellulitis, phlebitis, muscle tightness and pain in extremity with PNEUMOVAX 23 was not reported. Upon internal review, cellulitis was considered as a medically significant event. Additional information has been requested.
Sex: F
Vaccine: PPV, PPV
Symptoms: Ultrasound scan
Clinical narrative: This spontaneous report has been received from a nurse/administrator and referred to a 69-year-old female patient. The patient's relevant concurrent conditions included a drug/allergy to Iodine. She did not have any relevant historical conditions and concomitant therapies to be reported. On 10-MAY-2017, the patient was vaccinated with a dose of PNEUMOVAX 23 intramuscularly in her right upper arm (strength, dose, and frequency were not reported; lot number M022947 with an expiration date 11-NOV-2017) for prophylaxis. Then on 11-MAY-2017, the patient went to the nurse's office and she presented at the injection site phlebitis, cellulitis, tightness (almost bursting) and was extremely painful. On the same day, the patient was ordered for an ultrasound to rule out a deep vein thrombosis (DVT) (results not provided). The patient was started on therapy with clindamycin, BACTROBAN, BENADRYL, and PEPCID. At the time of this report, the outcome of cellulitis, phlebitis, muscle tightness and pain in extremity was unknown. The causality assessment between cellulitis, phlebitis, muscle tightness and pain in extremity with PNEUMOVAX 23 was not reported. Upon internal review, cellulitis was considered as a medically significant event. Additional information has been requested.
Sex: F
Vaccine: PPV, PPV
Symptoms: Erythema, Oedema peripheral, Pain in extremity
Clinical narrative: This spontaneous report has been received from a nurse/administrator and referred to a 69-year-old female patient. The patient's relevant concurrent conditions included a drug/allergy to Iodine. She did not have any relevant historical conditions and concomitant therapies to be reported. On 10-MAY-2017, the patient was vaccinated with a dose of PNEUMOVAX 23 intramuscularly in her right upper arm (strength, dose, and frequency were not reported; lot number M022947 with an expiration date 11-NOV-2017) for prophylaxis. Then on 11-MAY-2017, the patient went to the nurse's office and she presented at the injection site phlebitis, cellulitis, tightness (almost bursting) and was extremely painful. On the same day, the patient was ordered for an ultrasound to rule out a deep vein thrombosis (DVT) (results not provided). The patient was started on therapy with clindamycin, BACTROBAN, BENADRYL, and PEPCID. At the time of this report, the outcome of cellulitis, phlebitis, muscle tightness and pain in extremity was unknown. The causality assessment between cellulitis, phlebitis, muscle tightness and pain in extremity with PNEUMOVAX 23 was not reported. Upon internal review, cellulitis was considered as a medically significant event. Additional information has been requested.
Sex: M
Vaccine: HPV9
Symptoms: Dizziness, Drug screen, Full blood count, Headache, Hypoaesthesia
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act refers to a 13 year old male patient. The patient's past drugs included albuterol, cefdinir, guaifenesin/codeine, ZITHROMAX. The patient's historical conditions included rash and mild intermittent asthma. The patient's concurrent conditions included mild dry cough with a cold this week, mild intermittent asthma (triggered by viral illnesses) and cough with exercise. On 16-NOV-2016, the patient was vaccinated with GARDASIL 9 (lot# M009116), (route: intramuscular) in the left arm. On 16-NOV-2016, numbness and tingling in bilateral hands and legs/feet, headache, muscle weakness, vomiting and lightheadedness. Drug screen, urinalysis, CMP and CBC labs done at the hospital. The outcome of the events was reported as recovered. The causality of the events was unknown. Additional information is not expected because no further information could be obtained from the regulatory authority.
Sex: M
Vaccine: HPV9
Symptoms: Metabolic function test, Muscular weakness, Paraesthesia, Urine analysis, Vomiting
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act refers to a 13 year old male patient. The patient's past drugs included albuterol, cefdinir, guaifenesin/codeine, ZITHROMAX. The patient's historical conditions included rash and mild intermittent asthma. The patient's concurrent conditions included mild dry cough with a cold this week, mild intermittent asthma (triggered by viral illnesses) and cough with exercise. On 16-NOV-2016, the patient was vaccinated with GARDASIL 9 (lot# M009116), (route: intramuscular) in the left arm. On 16-NOV-2016, numbness and tingling in bilateral hands and legs/feet, headache, muscle weakness, vomiting and lightheadedness. Drug screen, urinalysis, CMP and CBC labs done at the hospital. The outcome of the events was reported as recovered. The causality of the events was unknown. Additional information is not expected because no further information could be obtained from the regulatory authority.
Sex: M
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act refers to a 11 year old male patient. On 09-AUG-2016, the patient was vaccinated with GARDASIL 9 (lot # L043214), (route: intramuscular) in the left arm. On 09-AUG-2016, the patient experienced syncope. The outcome of syncope was reported as recovered. The causality of the event was unknown. Additional information is not expected because no further information could be obtained from the regulatory authority.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse, concerning unspecified number of patients of unknown age and gender. There were no concurrent conditions, medical history, drug reactions, allergies or concomitant medications reported. On unspecified dates, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 (dose, frequency, route, lot # and expiration date were not reported) for prophylaxis. The temperature of the PNEUMOVAX 23 was of 19 °C for a time frame of 11 hours. Previous temperature excursion occurred; however, the temperature information was unknown by the reporter. No data logger was involved. No adverse effects were reported. This is one of five reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1705USA008598: US-009507513-1705USA008600: US-009507513-1705USA008602: US-009507513-1705USA008605.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to an unknown number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. From 01-JAN-2017 to 15-MAY-2017, the patients were vaccinated with improperly stored doses of VARIVAX lot # M037643 with an expiration date of 01-SEP-2018 (doses, route of administration and anatomical location were not reported). The reporter stated that sterile diluent (MRK) lot# M019201 with expiration date of 24-OCT-2018 was not improperly stored. Administered doses of vaccine underwent a temperature excursion (temperature and time frame were not provided). No adverse reactions were reported. There was no previous temperature excursions reported. A digital data logger was not involved. No product quality complaint (PQC) was involved. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1705USA009026.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a pharmacy administrator via a company representative referring to an 85 year old male patient. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. In approximately 2014 (reported as about 3 years ago), the patient was vaccinated with a dose of ZOSTAVAX for prevention of shingles (dose, route, lot # and expiration date were not reported). It was stated that the patient had recurrent episodes of shingles on his foot since receiving the ZOSTAVAX injection. It was also reported that the patient sought his primary provider and he was treated with VALTREX for the adverse event. The reporter stated that, they felt this was a "weird situation". At the time of reporting the outcome of the event was unknown. A product quality complaint was not involved. The causality assessment between the adverse event and ZOSTAVAX was not provided. Additional information has been requested.
Sex: F
Vaccine: HPVX
Symptoms: Death
Clinical narrative: I belive this injection caused my daughter's death; This spontaneous report was received from the patient's father via social media, referring to a female patient of unknown age. The patient's medical history and concurrent conditions were not provided. On an unknown date, the patient was vaccinated with unspecified human papillomavirus (HPV) vaccine (manufacturer unknown), dosage, route, lot# and expiration date were not provided. Concomitant therapies were not reported. The patient's father stated that "he believed this injection caused his daughter death, the date of the patient's death was not provided, It was unknown if an autopsy was done. The outcome of the event was fatal. 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 registered nurse, concerning unspecified number of patients of unknown age and gender. There were no concurrent conditions, medical history, drug reactions, allergies or concomitant medications reported. On unspecified dates, the patients were vaccinated with an improperly stored dose of GARDASIL 9 injection (dose, frequency, route, lot # and expiration date were not reported) for prophylaxis. The temperature of the GARDASIL 9 was of 19 °C for a time frame of 11 hours. Previous temperature excursion occurred; however, the temperature information was unknown by the reporter. No data logger was involved. No adverse effects were reported. This is one of five reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1705USA007283: US-009507513-1705USA008600: US-009507513-1705USA008602: US-009507513-1705USA008605.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse, concerning unspecified number of patients of unknown age and gender. There were no concurrent conditions, medical history, drug reactions, allergies or concomitant medications reported. On unspecified dates, the patients were vaccinated with an improperly stored dose of RECOMBIVAX HB (dose, frequency, route, lot # and expiration date were not reported) for prophylaxis. The temperature of the RECOMBIVAX HB was of 19 °C for a time frame of 11 hours. Previous temperature excursion occurred; however, the temperature information was unknown by the reporter. No data logger was involved. No adverse effects were reported. This is one of five reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1705USA007283: US-009507513-1705USA008598: US-009507513-1705USA008602: US-009507513-1705USA008605.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse, concerning unspecified number of patients of unknown age and gender. There were no concurrent conditions, medical history, drug reactions, allergies or concomitant medications reported. On unspecified dates, the patients were vaccinated with an improperly stored dose of VAQTA (dose, frequency, route, lot # and expiration date were not reported) for prophylaxis. The temperature of the VAQTA was of 19 °C for a time frame of 11 hours. Previous temperature excursion occurred; however, the temperature information was unknown by the reporter. No data logger was involved. No adverse effects were reported. This is one of five reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1705USA007283: US-009507513-1705USA008598: US-009507513-1705USA008600: US-009507513-1705USA008605.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse, concerning unspecified number of patients of unknown age and gender. There were no concurrent conditions, medical history, drug reactions, allergies or concomitant medications reported. On unspecified dates, the patients were vaccinated with an improperly stored dose of ZOSTAVAX (dose, frequency, route, lot # and expiration date were not reported) for prophylaxis. The temperature of the ZOSTAVAX was of 19 °C for a time frame of 11 hours. Previous temperature excursion occurred; however, the temperature information was unknown by the reporter. No data logger was involved. No adverse effects were reported. This is one of five reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1705USA008598: US-009507513-1705USA007283: US-009507513-1705USA008602: US-009507513-1705USA008600.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to an unknown number of patients of unknown age and gender. No information about the patient's medical history, concurrent conditions or concomitant medications was provided. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX for prophylaxis, that underwent a temperature excursion of - 14 degrees Celsius to -10 degrees Celsius for a time frame of 18 hours and 17 minutes and the Digital data logger was involved. Concomitant therapies included sterile diluent. No adverse effects were reported and no product quality complaint was involved. This is one of two cases from the same reporter. Additional information is not expected as no consent for follow-up was provided. Sender's Comments: US-009507513-1705USA000915.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to multiple unspecified patients of unknown age and gender. On 12-JUL-2016, the patients were vaccinated with improperly stored doses of ROTATEQ (lot # L033543 with 30-MAY-2017 and L048854 with 31-AUG-2017), orally for prophylaxis after a reported temperature excursion on the same day. The time frame was 1.7 degrees Celsius for 2 hours. It was back in range. The vaccines previously were exposed to 1.9 degrees Celsius for 30 minutes, for a cumulative time out of range of 2 hours and 30 minutes. There were no adverse effects reported. No product quality complaint was involved. This is one of two reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA004124.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to an unknown number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. From 01-JAN-2017 to 15-MAY-2017, the patients were vaccinated with improperly stored doses of M-M-R II lot # M028131 with an expiration date of 03-JUN-2018 (therapy type, doses, route of administration and anatomical location were not provided). The reporter stated that sterile diluent (MRK) lot # M019201 with expiration date of 24-OCT-2018 was not improperly stored. Administered doses of vaccine underwent a temperature excursion (temperature and time frame were not provided). No adverse reactions were reported. There was no previous temperature excursions reported. A digital data logger was not involved. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1705USA007766.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # N002720, with expiration date on 12-MAY-2019 (dose, route and site of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion from 47 degrees Fahrenheit to 77 degrees Fahrenheit for 192 hours. Data logger was involved. There were no previous excursions reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: This spontaneous report was received from a physician concerning a patient of an unknown age and gender. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not reported. On an unspecified date in 2016 (reported as "last year"), the patient was vaccinated with PNEUMOVAX 23 single dose (dose, route, lot number and expiration date were not reported) for prophylaxis. On an unknown date after receiving the vaccine of PNEUMOVAX 23, the patient developed fever. At the time of reporting, the outcome of the event was not reported. The causal relationship between the event and PNEUMOVAX 23 was not reported. Additional information has been requested.
Sex: F
Vaccine: TTOX
Symptoms: Allergy to vaccine, Erythema, Swelling
Clinical narrative: Initial unsolicited report received from a Physician on 09-MAY-2017. This case involves a female patient (age not reported) who was vaccinated with dose of TETANUS TOXOID (batch number, expiry date, dose and dose in series, route of administration were not reported) in an unknown site on an unspecified date. Patient's medical history and concomitant medications were not reported. On 27-Oct-2014, following the vaccination, the patient had developed allergies to vaccine, red and swollen area twice. Laboratory investigations and corrective treatment were not reported. The outcome of events was not reported. List of documents held by sender: none.
Age: 2.0
Sex: M
Vaccine: DTAP
Symptoms: Inappropriate schedule of drug administration, Miliaria, Urticaria
Clinical narrative: Initial unsolicited misuse report received from a consumer (patient's mother) on 09-May-2017. This case involves a 31-month-old male patient (reported as 2 and half year) who was vaccinated with second dose of DAPTACEL (Batch number, expiry date and dose were not reported) intramuscularly in left leg on 13-May-2016. Illness at the time of vaccination was reported as none and pre-existing physician diagnosed allergies, birth defects, medical conditions included allergies: no known drug allergies, seasonal allergies for pollen, trees, and grasses. Concomitant medications were not reported. On 13-May-2016, one hour following the vaccination, the patient had experienced 2 hives on chest and seven hours following the vaccination, the patient had developed rash that looked like a "heat rash" on right leg which was the opposite leg in which the patient had received vaccination. It was also reported that no other symptoms had seen. It was a case of inappropriate schedule of vaccine administered. Laboratory investigations and corrective treatments were not reported. On an unknown date, within days, the patient recovered from the events. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 13.0
Sex: F
Vaccine: MNQ
Symptoms: Blood test normal, Electrocardiogram normal, Foaming at mouth, Muscle twitching, Seizure
Clinical narrative: Seizure, twitching, foaming at mouth, for 30 seconds. Tx: ED visit, saline IV, blood/urine test, EKG.
Age: 13.0
Sex: F
Vaccine: MNQ
Symptoms: Urine analysis normal
Clinical narrative: Seizure, twitching, foaming at mouth, for 30 seconds. Tx: ED visit, saline IV, blood/urine test, EKG.
Age: 32.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: Red, swollen, itchy.
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling, Joint effusion
Clinical narrative: Injection site is swollen/painful. Feels like elbow is retaining water.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Eye movement disorder, Tremor
Clinical narrative: SHAKING AND ABNORMAL EYE MOVEMENTS.
Age: 0.92
Sex: M
Vaccine: DTAP, HIBV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Temp of 98.2, redness and swelling on area of injection.
Age: 50.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site pain, Injection site rash
Clinical narrative: Patient complained of redness, rash, and tenderness at the site of injection at the time stated above. She states that the symptoms have begun to resolve on their own as of 05/18/2017 at 9:00 AM.
Age: 43.0
Sex: F
Vaccine: MNQ
Symptoms: Full blood count, Injection site pain, Injection site swelling
Clinical narrative: Patient has pain and swelling to left deltoid (4" x 4") and also to left elbow area (4" x 3 ").
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse and refers to multiple patients of unknown demographics. The patients' medical history, concomitant medications and concurrent conditions were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of ROTATEQ orally, lot # M038846, expiration date 26-APR-2018, for prophylaxis. The doses were stored in temperature between 9 degrees Celsius (C) to 25 C (9.7 C) for 7 hours and 20 minutes which was recorded by a digital data logger. There was no previous temperature excursion reported. No adverse effects were reported. Product quality complaint was not involved. This is one of two reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1705USA004388.
Age: 13.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to 13 year old patient of unknown gender. There was no information regarding the patient's concomitant medications, medical history, drug reactions or allergies provided. On an unknown date, the patient was inadvertently vaccinated with properly stored PROQUAD injection for prophylaxis (dose, route of administration, lot number and expiration date were not provided) which was reconstituted with properly stored sterile diluent (lot number and expiration date were not provided). No adverse effects was reported. There was no product quality complaint involved in this case. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: This spontaneous report was received from a nurse via a company representative and refers to a female patient of unknown age. The patient had no pertinent medical history. No information regarding the patient's concomitant medications, drug reactions or allergies was provided. On an unknown date, the patient was vaccinated with GARDASIL 0.5 ml (dose also reported as unknown) (route of administration, lot number and expiration date were not reported) for prevention of Human Papilloma Virus. After receiving the vaccine, the patient fainted. The nurse caught the patient and the patient was fine. The company representative did not know if this was the patient's first dose of GARDASIL and did not know if the patient received any subsequent doses. The patient did not seek medical attention and no treatment was given for the adverse event. There were no lab diagnostics studies performed. The patient recovered soon after the event occurred. There was no product quality complaint involved in this case. The relatedness between the event and GARDASIL was not reported. 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 and refers to multiple patients of unknown demographics. The patients' medical history, concomitant medications and concurrent conditions were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of PEDVAXHIB lot # M034189, expiration date 23-MAY-2019 (route of administration and anatomical location were not reported), for prophylaxis. The doses were stored in temperature between 9 degrees Celsius (C) to 25 C (9.7 C) for 7 hours and 20 minutes which was recorded by a digital data logger. There was no previous temperature excursion reported. No adverse effects were reported. Product quality complaint was not involved. This is one of two reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA012463.
Age: 84.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Ophthalmic herpes zoster
Clinical narrative: This spontaneous report as received from a approximately 90 years old male patient of unknown age reporting on himself. The patient had allergy for sorbitol and azithromycin (ZITHROMAX). The patient had no medical history. In February 2010 the patient was vaccinated with ZOSTAVAX (dose and route of administration were not reported). Concomitant therapies included simvastatin(ZOCOR), lisinopril(manufacturer unknown), furosemide(LASIX), dorzolamide hydrochloride (+) timolol maleate(COSOPT), latanoprost(XALATAN) and aspirin(manufacturer unknown). In May 2016, the patient developed shingles in his eye and forehead. The patient saw his ophthalmologist, who prescribed something expensive for the shingles infection. Lab diagnostic studies were not performed. The patient's condition was unresolved at the time of the report.     Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a physician and refers to a patient of unknown age and gender. The patient's concomitant medications, pertinent medical history and drug reactions or allergies were not reported. On 09-MAY-2017, the patient was vaccinated with an expired dose of ZOSTAVAX, 19400 plaque-forming units (PFU) with an expiry date of 03-MAY-2017 (exact dose, route of administration and lot # were not reported). No adverse effects were reported. Additional information is not expected as no consent to contact the physician was granted.