chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: FLU3, HPV9, MNQ, TDAP
Symptoms: Cold sweat, Dizziness, Hyperhidrosis, 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 (VAERS # 611437) on 04-APR-2017. This spontaneous report as received from a regulatory authority refers to a 12 year old female patient. Patient had no pertinent medical history and current illnesses. Other medications and prior vaccinations were not reported. On 24-NOV-2015, the patient was vaccinated with GARDASIL 9 intramuscularly in the right arm, lot # L013429, (dose, frequency and lot expiration date were not reported) for prophylaxis. Other suspect therapies included BOOSTRIX (vaccinated date : 24-NOV-2015, intramuscularly in the right arm, lot# 2729X; dose and expiration date unknown), FLUZONE (vaccinated date: 24-NOV-2015, intramuscularly in the left arm, lot# UI479AA; dose and expiration date unknown) and MENACTRA (vaccinated date : 24-NOV-2015, intramuscularly in the left arm, lot# U5178AA; dose and expiration date unknown). Lab data was reported as BP: 61/47 P: 47. Upon dismissal: BP: 91/51 P: 66 and it was reported that patient was talking, oriented and smiling. On 24-NOV-2015, the patient experienced cold sweat, pallor, hyperhidrosis and dizziness. The outcome of cold sweat, pallor, hyperhidrosis and dizziness were reported as recovered/resolved. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9
Symptoms: Feeling hot, Headache, Pain, Tremor
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 (VAERS # 611751) on 04-APR-2017. This spontaneous report as received from a regulatory authority refers to a 17 year old female patient. The patient's other medications included TRI-SPRINTEC. The patient's medical history, prior vaccinations and concurrent illness were not reported. On 24-NOV-2015, the patient was vaccinated with the first dose of GARDASIL 9 intramuscularly in the left arm, lot # L016428 (dose, frequency and lot expiration date were not reported) for prophylaxis. And on the same day as per the phone call from patient's mother which was received approximately 7 hours after vaccine administrated, the patient experienced headache, shaking, hot and general body aches. On unknown date, the patient underwent emergency room (ER) visit. The outcome of events feeling hot, headache, tremor and pain was reported as unknown. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9
Symptoms: Blood test, Computerised tomogram, Culture urine, Electrocardiogram, Electroencephalogram
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 (VAERS ID: 612689). This spontaneous report was received from a regulatory authority concerning a 14 year old female patient. Patient had no known allergies (NKA) and current illnesses included head cold. Other medications and prior vaccinations were not reported. On 20-AUG-2015, the patient was vaccinated with 2nd dose of GARDASIL 9, lot # L019286, intramuscularly in the right arm (dose and lot expiration date were not reported) for prophylaxis. "The patient's parent stated that the patient was at school and parent was at his/her work when he/she received a call that their daughter was being transported to the emergency room (ER) via ambulance because she had a seizure on 05-SEP-2015. On the same day, the patient underwent blood test, urine analysis, electroencephalogram, electrocardiogram, culture urine and Computerized tomogram. Lab data: Urinalysis-Culture and sensitivity (UA C&S). She had approximately 51 seizures from that Friday till Monday. And still if exposed to flashing lights, she had them. She only had 2 since that Monday, one being on September 25th and the other being the same day." The outcome of blood test, urine analysis, seizure, electroencephalogram, electrocardiogram, culture urine and computerised tomogram were reported as unknown. Causality assessment was not reported. Agency considered the case to be serious as these events led to hospitalization. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9
Symptoms: Seizure, Urine analysis
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 (VAERS ID: 612689). This spontaneous report was received from a regulatory authority concerning a 14 year old female patient. Patient had no known allergies (NKA) and current illnesses included head cold. Other medications and prior vaccinations were not reported. On 20-AUG-2015, the patient was vaccinated with 2nd dose of GARDASIL 9, lot # L019286, intramuscularly in the right arm (dose and lot expiration date were not reported) for prophylaxis. "The patient's parent stated that the patient was at school and parent was at his/her work when he/she received a call that their daughter was being transported to the emergency room (ER) via ambulance because she had a seizure on 05-SEP-2015. On the same day, the patient underwent blood test, urine analysis, electroencephalogram, electrocardiogram, culture urine and Computerized tomogram. Lab data: Urinalysis-Culture and sensitivity (UA C&S). She had approximately 51 seizures from that Friday till Monday. And still if exposed to flashing lights, she had them. She only had 2 since that Monday, one being on September 25th and the other being the same day." The outcome of blood test, urine analysis, seizure, electroencephalogram, electrocardiogram, culture urine and computerised tomogram were reported as unknown. Causality assessment was not reported. Agency considered the case to be serious as these events led to hospitalization. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9
Symptoms: Injection site erythema, Injection site urticaria, Urticaria
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 (VAERS # 612934) on 04-APR-2017. This spontaneous report as received from a regulatory authority refers to a 12 year old female patient. The patient's medical history included diagnosis of streptococcal pharyngitis and allergy to bactrim. Patient had no current illnesses. On 23-NOV-2015, the patient was vaccinated with GARDASIL 9 lot # L019287, intramuscularly in the left arm (dose, frequency and lot expiration date were not reported) for prophylaxis. The patient was presented to emergency room (ER visit) as a result of reaction to medication. Patient developed redness at the site of band aid that was applied to the vaccinated site and appeared to be like hives as per ER physician. On 26-NOV-2015, the patient experienced injection site erythema and injection site urticarial. The outcome of injection site erythema and injection site urticaria were reported as recovered/resolved. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: M
Vaccine: FLU4, HPV9
Symptoms: Seizure
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 (VAERS # 616046) on 04-APR-2017. This spontaneous report as received from a regulatory authority refers to a 17 year old male patient. The patient's medical history included Peters anomaly, blindness and epilepsy since age 6. The patient had no concurrent illnesses. The patient's concomitant therapies included KEPPRA, Valproic acid and Pyridoxine. On 22-DEC-2015, the patient was vaccinated with the first dose of GARDASIL 9 intramuscularly in the left arm, lot # L014415 (dose, frequency and expiration date were not reported) for prophylaxis. Other suspect therapies included FLUARIX QUADRIVALENT dose number: 7 (prior vaccination details not reported), administered intramuscularly in the left arm, lot# BS79K (dose, frequency and expiration date unknown) for prophylaxis. On 22-DEC-2015 patient experienced two prolonged seizures which required emergency medication (DIASTAT) and ER (emergency room) visit. The patient had no seizures previously in almost a year. The patient was in usual state of health (well) before the visit. At that point of time the reporter was not sure if the patient would be hospitalized. The outcome of event seizure was reported as recovered/resolved. Causality assessment was not reported. The agency considered the events to be life threatening and to have led to hospitalization. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 78.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Blood test normal, Computerised tomogram normal, Dyspnoea
Clinical narrative: Difficulty breathing, fuzzy thinking.
Age: 78.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Blood test, Dyspnoea, Nuclear magnetic resonance imaging, Thinking abnormal, X-ray
Clinical narrative: Difficulty breathing, fuzzy thinking.
Age: 7.0
Sex: F
Vaccine: FLU4, HEPA, MMRV, HEPA, MMRV, UNK
Symptoms: Erythema, Local swelling, Pain
Clinical narrative: Adverse effect of other viral vaccines, initial encounter on 2017-03-23.
Age: 7.0
Sex: F
Vaccine: FLU4, HEPA, MMRV, HEPA, MMRV, UNK
Symptoms: Vaccination complication
Clinical narrative: Adverse effect of other viral vaccines, initial encounter on 2017-03-23.
Age: 61.0
Sex: F
Vaccine: VARZOS, TDAP, VARZOS
Symptoms: Urticaria
Clinical narrative: Hives over entire body including the face.
Age: 61.0
Sex: F
Vaccine: VARZOS, TDAP, VARZOS
Symptoms: Lip swelling, Pruritus generalised, Speech disorder, Urticaria
Clinical narrative: Hives over entire body including the face.
Age: 56.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a phlebotomist concerning to a male patient of unknown age.  The patient's concurrent conditions, medical history, drug reaction/allergies, and concomitant therapies were not reported. On 14-MAR-2017, the patient was vaccinated with an expired dose of PNEUMOVAX23 lot # L035687, (expiration date 16-FEB-2017) for prophylaxis (the route, dose, frequency, and strength were not reported). No adverse effects were reported in the patient.  There was no product quality complaint involved. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from an office manager and refers to unspecified number of patients of unknown age and gender. No information regarding the patients' pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On unknown dates reported as "over the past 3 months", the patients were vaccinated with improperly stored doses of M-M-R II lot # L041455 with expiration date: 22-OCT-2017, albumin status: recombinant human albumin (rHA) and lot# L015279 with expiration date: 30-APR-2017, albumin status: recombinant human albumin (rHA) (dose, route and site of administration were not reported). No adverse experience was reported. Administered doses of vaccines experienced the temperature excursion of 47 degrees Fahrenheit to 77 degrees Fahrenheit for 21 hours cumulatively over "3 months," on unspecified dates. Data logger was not 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-009507513-1703USA014473: US-009507513-1703USA014472: US-009507513-1703USA014471: US-009507513-1703USA014470: US-009507513-1703USA014469.
Sex: F
Vaccine: MMR
Symptoms: Exposure during pregnancy
Clinical narrative: This spontaneous prospective pregnancy report was received from a medical assistant concerning a 32 year old female patient. On an unknown date, the patient was vaccinated with a dose of M-M-R II (dose, route and lot # not reported) while pregnant. The patient's last menstrual period and her estimated date of delivery were unknown. The pregnancy outcome was pending. Additional information is not expected as there is no contact information.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site reaction, Injection site swelling, Injection site warmth, Rash erythematous
Clinical narrative: This spontaneous report was received from a pharmacist concerning a 60-year-old male patient. The patient's pertinent medical history, concurrent conditions, and concomitant medications were not reported. The patient's drug reactions/allergies included dizziness caused by penicillin. On 22-MAR-2017, the patient was vaccinated with ZOSTAVAX subcutaneously for vaccination (dose, lot number, and expiration date were not reported for both products). On the same date after vaccination, the patient developed warm, red rash with swelling at the injection site, but he did not receive any treatment for the events. The patient sought medical attention by contacting the pharmacist, and the pharmacist declined Varicella-Zoster Virus (VZV) packet. At the time of the report, the symptoms were unresolved, the causality was not reported and it was unknown if lab diagnostics were performed. No further information was available. 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 an unspecified number of patients with unknown demographics. On an unknown dates, the patients were vaccinated with an imporperly stored doses of GARDASIL 9 lot # M032650, expiration date 31-MAR-2019 for prophylaxis (route, dosage and anatomical location were not reported). The storage conditions were reported as follows: temperature 50° F, time frame 2 hours, with no previous temperature excursion. A data logger issue was involved. No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA002261.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a nurse concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not provided. On an unknown date in October 2016, the patient was vaccinated with the first dose of GARDASIL 9 (dosage schedule, route of administration, anatomical location, lot # and expiration date were not provided), for prophylaxis. On 28-NOV-2016, 1 month later, the patient was vaccinated "early" with a second dose of GARDASIL 9 (lot # M013636 with expiration date 15-FEB-2018) (dosage schedule, route of administration and anatomical location were not provided), for prophylaxis. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies was provided. On 13-FEB-2017 at 14:54, the patient was vaccinated with an improperly stored VARIVAX (lot # M031969) for prophylaxis (expiration date, dose and route of administration were not reported). It was reported that the vaccine underwent previous temperature excursions, but the number of previous excursions, time frames and values of incorrect temperature were unknown. A digital data logger was used. No adverse effects were reported. Product quality complaint was not involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA008441: US-009507513-1704USA000389: US-009507513-1704USA000390: US-009507513-1704USA000391: US-009507513-1704USA000392: US-009507513-1704USA000393: US-009507513-1704USA000394: US-009507513-1704USA000395: US-009507513-1704USA000396: US-009507513-1704USA000397: US-009507513-1704USA000398: US-009507513-1704USA000399: US-009507513-1704USA000400: US-009507513-1704USA000401: US-009507513-1704USA000402: US-009507513-1704USA000403: US-009507513-1704USA000404: US-009507513-1704USA000405: US-009507513-1704USA000406: US-009507513-1704USA000407: US-009507513-1704USA000408: US-009507513-1704USA000409: US-009507513-1704USA000410: US-009507513-1704USA000411: US-009507513-1704USA000412: US-009507513-1704USA000413: US-009507513-1704USA000414: US-009507513-1704USA000415: US-009507513-1704USA000416: US-009507513-1704USA000417: US-009507513-1704USA000418: US-009507513-1704USA000419: US-009507513-1704USA000420: US-009507513-1704USA000421: US-009507513-1704USA000422: US-009507513-1704USA000423: US-009507513-1704USA000424: US-009507513-1704USA000425: US-009507513-1704USA000426: US-009507513-1704USA000427: US-009507513-1704USA000428: US-009507513-1704USA000429: US-009507513-1704USA000430: US-009507513-1704USA000431: US-009507513-1704USA000432: US-009507513-1704USA000433: US-009507513-1704USA000434: US-009507513-1704USA000435: US-009507513-1704USA000436: US-009507513-1704USA000437: US-009507513-1704USA000438: US-009507513-1704USA000439: US-009507513-1704USA000440: US-009507513-1704USA000441: US-009507513-1704USA000442: US-009507513-1704USA000443: US-009507513-1704USA000444: US-009507513-1704USA000445: US-009507513-1704USA000446: US-009507513-1704USA000447: US-009507513-1704USA000448: US-009507513-1704USA000449: US-009507513-1704USA000450: US-009507513-1704USA000451: US-009507513-1704USA000452: US-009507513-1704USA000453: US-009507513-1704USA000455: US-009507513-1704USA000456: US-009507513-1704USA000457.
Age: 33.0
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse (LPN) referring to a 33 year old patient of an unknown gender. The patient's concurrent conditions, medical history or concomitant medication were not provided. On 31-MAR-2017, the patient was vaccinated with an expired dose of M-M-R II Lot # reported as L009212 and an expiration date of 17-MAR-2017, intramuscular (strength and dose were not provided) for prophylaxis. No adverse reactions were reported. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Rash
Clinical narrative: This spontaneous report was received from a pharmacist, concerning a 60 year-old female patient of unknown age. The patient did not have concurrent conditions, medical history or drug reactions or allergies. Her concomitant therapies included AMBIEN, EFFEXOR, vitamin D (unspecified) and omeprazole. On 28-MAR-2017, the patient was vaccinated with a dose of ZOSTAVAX vial (dose, frequency and route were not reported) lot # M038350 with expiration date of 06-DEC-2017, for prophylaxis. On 03-APR-2017, the patient went to the pharmacy with a "2-3 inch rash on her left arm, red, slightly raised no blisters". No treatment was given and no laboratories were performed. The pharmacist was interested in Varicella Zoster Virus (VZV) analysis by Polymerase Chain Reaction (PCR) and wanted to send viral isolates. At the time of the report, the patient had not recovered from the adverse events. The causality between the adverse events and ZOSTAVAX was unknown. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative refers to two patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with the doses of ZOSTAVAX (dose, route of administration, lot # and expiration date were not reported) for prophylaxis. On unknown dates, the patients experienced shingles. The outcome of shingles was unknown. The relatedness between shingles and ZOSTAVAX was not provided. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Immediate post-injection reaction, Influenza like illness, Mobility decreased, Pain
Clinical narrative: This spontaneous report was received from a currently 61 year-old female patient concerning herself. The patient's pertinent medical history, drug reactions/allergies and concomitant medication were reported as none. On an unspecified date in October 2016 (reported as in the "middle of October, 2016), the patient was vaccinated with a dose of ZOSTAVAX 19400 Plaque Forming Units, subcutaneously, for prevention from shingles (lot # and expiration date were not reported) at an appointment for a check up with her physician. It was reported that right after ZOSTAVAX administration, she felt like she had the flu. She ached all over. In November 2016, the patient's "knees were bothering" her. The patient self medicated with naproxen sodium (ALEVE). It was stated that the "symptoms got progressively worse". The patient stated that she "did not know what was wrong". From the end of November 2016 to the beginning of December 2016, the patient explained that the aches were "really kicking in". After Christmas 2016, "it got really bad". In January 2017, the patient had an episode that had her visit the physician. It was reported that she woke up during the night with her arm "throbbing like a toothache" and she "couldn't move in the bed". On an unspecified date in January 2017, the patient was diagnosed with polymyalgia rheumatica. At the time of reporting the patient had not recovered from polymyalgia rheumatica and the outcome of flue like symptoms was unknown. A product quality complaint was not involved. The causality assessment between the events and ZOSTAVAX was not provided. Upon internal review polymyalgia rheumatica was determined to be a medically significant event. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Polymyalgia rheumatica
Clinical narrative: This spontaneous report was received from a currently 61 year-old female patient concerning herself. The patient's pertinent medical history, drug reactions/allergies and concomitant medication were reported as none. On an unspecified date in October 2016 (reported as in the "middle of October, 2016), the patient was vaccinated with a dose of ZOSTAVAX 19400 Plaque Forming Units, subcutaneously, for prevention from shingles (lot # and expiration date were not reported) at an appointment for a check up with her physician. It was reported that right after ZOSTAVAX administration, she felt like she had the flu. She ached all over. In November 2016, the patient's "knees were bothering" her. The patient self medicated with naproxen sodium (ALEVE). It was stated that the "symptoms got progressively worse". The patient stated that she "did not know what was wrong". From the end of November 2016 to the beginning of December 2016, the patient explained that the aches were "really kicking in". After Christmas 2016, "it got really bad". In January 2017, the patient had an episode that had her visit the physician. It was reported that she woke up during the night with her arm "throbbing like a toothache" and she "couldn't move in the bed". On an unspecified date in January 2017, the patient was diagnosed with polymyalgia rheumatica. At the time of reporting the patient had not recovered from polymyalgia rheumatica and the outcome of flue like symptoms was unknown. A product quality complaint was not involved. The causality assessment between the events and ZOSTAVAX was not provided. Upon internal review polymyalgia rheumatica was determined to be a medically significant event. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Malaise
Clinical narrative: This spontaneous report has been received from a medical assistant via company representative regarding a female patient of unknown age. Information regarding patient's medical history, concurrent condition, drug reactions/allergies and concomitant medication were unknown. Approximately in 2012 (reported as 5 years ago), the patient was vaccinated with GARDASIL injection (dosing details were not provided) for Human Papillomavirus (HPV) prevention. Reporter mentioned that the patient became sick after receiving the vaccine at the office. She required medical attention and had to be airlifted to an unspecified hospital from the office. It was unknown if it was the first, second or third dose in the GARDASIL series. Outcome of the event was unknown. Causality assessment was not provided. Reporter considered the event to be serious due to hospitalization. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: HIBV, MMRV, PNC13, VARCEL
Symptoms: Extra dose administered, Wrong drug administered
Clinical narrative: PROQUAD was given instead of MMR along with the Varicella. Employee notified. Was also contacted by HD on 4/10/17. The same day I found the error when doing balancing. Employee stated that she originally pulled out the PROQUAD to give but was then informed that it was only patient's 1st doses and informed that individual doses of MMR and Varicella suppose to be given first to make sure no reaction noted.  Informed all staff members the importance of double checking all vaccines to be given with other employees.
Age: 65.0
Sex: M
Vaccine: HEP
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: RECOMBIVAX 40mcg was given instead of RECOMBIVAX 10mcg.  No reaction at that time reported. When error was discovered on 4/5/2017 patient was contacted  and he stated he has no reaction or discomfort.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received on 17-MAR-2017 from a Registered Nurse referring to unspecified patients of unknown age and gender. The patients' concurrent conditions and medical history was not reported. On an unspecified dates, an unspecified number of unspecified patients were vaccinated with improperly stored doses of ROTATEQ lot # M025565 expiration 06-NOV-2017  (strength, dose number, dosage and route were unspecified. The vaccine was exposed to temperature of 49 °F; for time frame of 64 hours. There was no previous temperature excursion. No adverse effect was reported.   Additional information was received on 20-MAR-2017  from  a registered nurse  who reported some additional improperly stored  doses might have been given to unknown number of patients. No adverse effect reported. This is one of two reports received from the same reporter.  Additional information has been requested.; Sender's Comments: US-009507513-1704USA004411:
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and a office manager referring to five patients of unspecified gender and age. In February and March 2017, five patients were vaccinated with improperly stored doses of VAQTA lot number M033611, expiration date 02-MAR-2018 or lot number M036459, expiration date 18-JAN-2018 (formulation, dose, frequency, route of administration and indication were not reported). No adverse effects were reported. The doses were stored in temperature between 47 degrees Fahrenheit to 77 degrees Fahrenheit for 61 hours. Data logger was involved. There was no previous excursion reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1703USA008878.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative
Clinical narrative: This spontaneous report was received from a nurse practitioner and refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' pertinent medical history, drug reactions or allergies was not reported. On an unknown dates, the patients were vaccinated with three doses of RECOMBIVAX HB for prophylaxis (dose, route of administration, lot number and expiration date were not reported. Subsequently, the patients were find to have negative titers (hepatitis b surface antibody negative). The outcome of the event was not reported. The relationship between the event and RECOMBIVAX HB was not reported. Additional information is not expected as there was no consent to contact reporter.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies was provided. On 10-JAN-2017 at 16:42, the patient was vaccinated with an improperly stored VARIVAX (lot # M031969) for prophylaxis (expiration date, dose and route of administration were not reported). It was reported that the vaccine underwent previous temperature excursions, but the number of previous excursions, time frames and values of incorrect temperature were unknown. A digital data logger was used. No adverse effects were reported. Product quality complaint was not involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA008441: US-009507513-1704USA000389: US-009507513-1704USA000390: US-009507513-1704USA000391: US-009507513-1704USA000392: US-009507513-1704USA000393: US-009507513-1704USA000394: US-009507513-1704USA000395: US-009507513-1704USA000396: US-009507513-1704USA000397: US-009507513-1704USA000398: US-009507513-1704USA000399: US-009507513-1704USA000400: US-009507513-1704USA000401: US-009507513-1704USA000402: US-009507513-1704USA000403: US-009507513-1704USA000404: US-009507513-1704USA000405: US-009507513-1704USA000406: US-009507513-1704USA000407: US-009507513-1704USA000408: US-009507513-1704USA000409: US-009507513-1704USA000410: US-009507513-1704USA000412: US-009507513-1704USA000413: US-009507513-1704USA000414: US-009507513-1704USA000415: US-009507513-1704USA000416: US-009507513-1704USA000417: US-009507513-1704USA000418: US-009507513-1704USA000419: US-009507513-1704USA000420: US-009507513-1704USA000421: US-009507513-1704USA000422: US-009507513-1704USA000423: US-009507513-1704USA000424: US-009507513-1704USA000425: US-009507513-1704USA000426: US-009507513-1704USA000427: US-009507513-1704USA000428: US-009507513-1704USA000429: US-009507513-1704USA000430: US-009507513-1704USA000431: US-009507513-1704USA000432: US-009507513-1704USA000433: US-009507513-1704USA000434: US-009507513-1704USA000435: US-009507513-1704USA000436: US-009507513-1704USA000437: US-009507513-1704USA000438: US-009507513-1704USA000439: US-009507513-1704USA000440: US-009507513-1704USA000441: US-009507513-1704USA000442: US-009507513-1704USA000443: US-009507513-1704USA000444: US-009507513-1704USA000445: US-009507513-1704USA000446: US-009507513-1704USA000447: US-009507513-1704USA000448: US-009507513-1704USA000449: US-009507513-1704USA000450: US-009507513-1704USA000451: US-009507513-1704USA000452: US-009507513-1704USA000453: US-009507513-1704USA000454: US-009507513-1704USA000456: US-009507513-1704USA000457: US-009507513-1704USA000458.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a 70-year-old female patient. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 05-APR-2017, the patient was vaccinated with PNEUMOVAX23 lot # N003997 for prevention of pneumonia (dose, route of administration and expiration date were not reported). On the same day, the patient experienced swelling, pain, and a hot feeling at the injection site. The patient was diagnosed with cellulitis. The patient sought medical attention. Unspecified treatment was given for the adverse event. No lab diagnostic tests were performed. The outcome of the event and the relatedness between the event and PNEUMOVAX23 were not reported. Upon internal review, the event of cellulitis was determined to be medically significant. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a nurse practitioner via a company representative refers to a female patient of unknown age. The patient's medical history was not reported. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (lot #, dose, route and site of administration were not reported) for prophylaxis. Concomitant medications were unknown. On an unknown date, the patient developed shingles. She sought medical attention (unspecified). The outcome of event was unknown. The relatedness between the event and ZOSTAVAX was not reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA004417:
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received on 17-MAR-2017 from a Registered Nurse referring to unspecified  number of patients of unknown age and gender. The patients' concurrent conditions and medical history was not reported. On an unspecified dates, an unspecified number of unspecified patients were vaccinated with improperly stored doses of PNEUMOVAX23 with lot# L024118 and expiration date 26-MAR-2016, (strength, dose number, dosage and route were unspecified) for prophylaxis. The vaccine was exposed to temperature of 49 °F; for time frame of 64 hours. There was no previous temperature excursion. No adverse effect was reported.   Additional information was received on 20-MAR-2017  from  a registered nurse  who reported some additional improperly stored  doses might have been given to unknown number of patients. No adverse effect reported. This is one of two reports received from the same reporter.  Additional information has been requested.; Sender's Comments: US-009507513-1703USA008680:
Sex: F
Vaccine: HPVX
Symptoms: Adverse reaction
Clinical narrative: This spontaneous report was received from a nurse (who is also the patient's mother) via a company representative and refers to a female patient of unknown age. Medical history and concomitant medications were not provided. In approximately 2010 (reported as about six to seven years ago) the patient was vaccinated with either GARDASIL or GARDASIL 9 (route and lot # not provided). On an unspecified date, the patient experienced a "severe reaction" (not further specified). The nurse reported that she had a lawsuit in place regarding the vaccine. The outcome of the event was unknown. The reporter did not rate causality. Additional information is not expected as the reporter wished to remain anonymous.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a nurse practitioner via a company representative refers to an unspecified number of patients of unknown age and gender. The patients' medical history was not reported. On an unknown date, the patients were vaccinated with doses of ZOSTAVAX (lot #, dose, route and site of administration were not reported) for prophylaxis. Concomitant medications were unknown. On unknown dates, the patients developed shingles. The outcome of event was unknown. The relatedness between the event and ZOSTAVAX was not reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA003801:
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Anal incontinence, Dizziness, Fatigue, Syncope
Clinical narrative: Vasovagal syncope during blood draw immediately after injection; attempt to relocate so patient could lay down, vasovagal syncope again with loss of bowel control. Remained laying on floor for 45 mins until O2 Saturation and pulse increased. Felt tired and dizzy for the rest of the day.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site pain, Joint injection, Nuclear magnetic resonance imaging, Pain in extremity
Clinical narrative: I had no history of left shoulder pain prior to vaccinaton. Within 24 hours of vaccine administration, I had extreme pain and nearly complete immobility of left arm. Within one week, there was improvement, but still significant pain and immobility. After 6 months of treatment, including steroid injections to the shoulder and physical therapy, there is some additional improvement, but still a significant pain and loss of function of the left arm and shoulder. I am continuing with physical therapy.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: X-ray
Clinical narrative: I had no history of left shoulder pain prior to vaccinaton. Within 24 hours of vaccine administration, I had extreme pain and nearly complete immobility of left arm. Within one week, there was improvement, but still significant pain and immobility. After 6 months of treatment, including steroid injections to the shoulder and physical therapy, there is some additional improvement, but still a significant pain and loss of function of the left arm and shoulder. I am continuing with physical therapy.
Age: 29.0
Sex: M
Vaccine: YF
Symptoms: Dizziness, Flushing, Hypotension, Nausea, Pruritus
Clinical narrative: Feeling itch in palms, feet, lightheaded, nauseous, generalized flushing of skin.
Age: 13.0
Sex: F
Vaccine: HPVX
Symptoms: Seizure, Syncope
Clinical narrative: Seizure or Syncope - collapsed to floor. No fever or illness.
Age: 26.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Injection site pruritus, Mobility decreased, Peripheral swelling
Clinical narrative: Patient complained of "a lot of itching" on injection site; BENADRYL 25mg was ordered by provider and cold pack was placed on left arm for symptom relief; patient left 2 hours later stating she felt better. On 4/7/17 at 10:37 AM patient called clinic complaining of arm swelling and difficulty moving arm. Patient denied any other symptoms: fever, shortness of breath. After consulting with patient's medical provider patient was referred to ER.
Age: 68.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site pain, Myalgia
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer (patient). A patient of an unspecified age, gender, race and ethnicity received PREVNAR 13 single dose, on an unknown date, for immunization. Relevant medical history and concomitant medications were unknown. On an unspecified date, the patient experienced arm muscle pain. The patient asked if there were any actions in order to reduce the discomfort. The patient did not recover from injection site muscle pain, while clinical outcome of the other adverse event was unknown.
Age: 1.0
Sex: F
Vaccine: DTAPIPVHIB, FLUX, PNC13
Symptoms: Alanine aminotransferase increased, Albumin globulin ratio, Anion gap, Aspartate aminotransferase normal, Autism spectrum disorder
Clinical narrative: Patient had diarrhea from date of immunizations until 11/27, when she vomited several times in one hour with bloody mucus until bile.  Patient had been able to eat a certain formula and 5 safe foods without difficulty before immunizations and after immunizations, is unable to tolerate any foods at this time (April 2017).  Patient had blotchy facial rash and some facial swelling with each formula feeding for several weeks after which have resolved.  Also, patient had been taking a few steps independently and had a couple of words at the time of immunizations.  After immunizations, patient only said one word until March 2017 and did not get back to taking a few steps independently or using 2-3 words until March 2017.  Patient also started sleeping about 20 hours per day through December and January.
Age: 1.0
Sex: F
Vaccine: DTAPIPVHIB, FLUX, PNC13
Symptoms: Basophil count decreased, Blood 1,25-dihydroxycholecalciferol, Blood albumin normal, Blood alkaline phosphatase increased, Blood bilirubin decreased
Clinical narrative: Patient had diarrhea from date of immunizations until 11/27, when she vomited several times in one hour with bloody mucus until bile.  Patient had been able to eat a certain formula and 5 safe foods without difficulty before immunizations and after immunizations, is unable to tolerate any foods at this time (April 2017).  Patient had blotchy facial rash and some facial swelling with each formula feeding for several weeks after which have resolved.  Also, patient had been taking a few steps independently and had a couple of words at the time of immunizations.  After immunizations, patient only said one word until March 2017 and did not get back to taking a few steps independently or using 2-3 words until March 2017.  Patient also started sleeping about 20 hours per day through December and January.
Age: 1.0
Sex: F
Vaccine: DTAPIPVHIB, FLUX, PNC13
Symptoms: Blood calcium increased, Blood chloride normal, Blood creatinine decreased, Blood glucose normal, Blood potassium normal
Clinical narrative: Patient had diarrhea from date of immunizations until 11/27, when she vomited several times in one hour with bloody mucus until bile.  Patient had been able to eat a certain formula and 5 safe foods without difficulty before immunizations and after immunizations, is unable to tolerate any foods at this time (April 2017).  Patient had blotchy facial rash and some facial swelling with each formula feeding for several weeks after which have resolved.  Also, patient had been taking a few steps independently and had a couple of words at the time of immunizations.  After immunizations, patient only said one word until March 2017 and did not get back to taking a few steps independently or using 2-3 words until March 2017.  Patient also started sleeping about 20 hours per day through December and January.
Age: 1.0
Sex: F
Vaccine: DTAPIPVHIB, FLUX, PNC13
Symptoms: Blood sodium normal, Blood urea normal, C-reactive protein normal, Carbon dioxide normal, Diarrhoea
Clinical narrative: Patient had diarrhea from date of immunizations until 11/27, when she vomited several times in one hour with bloody mucus until bile.  Patient had been able to eat a certain formula and 5 safe foods without difficulty before immunizations and after immunizations, is unable to tolerate any foods at this time (April 2017).  Patient had blotchy facial rash and some facial swelling with each formula feeding for several weeks after which have resolved.  Also, patient had been taking a few steps independently and had a couple of words at the time of immunizations.  After immunizations, patient only said one word until March 2017 and did not get back to taking a few steps independently or using 2-3 words until March 2017.  Patient also started sleeping about 20 hours per day through December and January.
Age: 1.0
Sex: F
Vaccine: DTAPIPVHIB, FLUX, PNC13
Symptoms: Eosinophil count normal, Food intolerance, Globulins decreased, Haematemesis, Haematocrit normal
Clinical narrative: Patient had diarrhea from date of immunizations until 11/27, when she vomited several times in one hour with bloody mucus until bile.  Patient had been able to eat a certain formula and 5 safe foods without difficulty before immunizations and after immunizations, is unable to tolerate any foods at this time (April 2017).  Patient had blotchy facial rash and some facial swelling with each formula feeding for several weeks after which have resolved.  Also, patient had been taking a few steps independently and had a couple of words at the time of immunizations.  After immunizations, patient only said one word until March 2017 and did not get back to taking a few steps independently or using 2-3 words until March 2017.  Patient also started sleeping about 20 hours per day through December and January.
Age: 1.0
Sex: F
Vaccine: DTAPIPVHIB, FLUX, PNC13
Symptoms: Haemoglobin normal, Hypersomnia, Lymphocyte count increased, Mean cell haemoglobin concentration normal, Mean cell haemoglobin normal
Clinical narrative: Patient had diarrhea from date of immunizations until 11/27, when she vomited several times in one hour with bloody mucus until bile.  Patient had been able to eat a certain formula and 5 safe foods without difficulty before immunizations and after immunizations, is unable to tolerate any foods at this time (April 2017).  Patient had blotchy facial rash and some facial swelling with each formula feeding for several weeks after which have resolved.  Also, patient had been taking a few steps independently and had a couple of words at the time of immunizations.  After immunizations, patient only said one word until March 2017 and did not get back to taking a few steps independently or using 2-3 words until March 2017.  Patient also started sleeping about 20 hours per day through December and January.
Age: 1.0
Sex: F
Vaccine: DTAPIPVHIB, FLUX, PNC13
Symptoms: Mean cell volume normal, Monocyte count normal, Neutrophil count decreased, Platelet count normal, Protein total normal
Clinical narrative: Patient had diarrhea from date of immunizations until 11/27, when she vomited several times in one hour with bloody mucus until bile.  Patient had been able to eat a certain formula and 5 safe foods without difficulty before immunizations and after immunizations, is unable to tolerate any foods at this time (April 2017).  Patient had blotchy facial rash and some facial swelling with each formula feeding for several weeks after which have resolved.  Also, patient had been taking a few steps independently and had a couple of words at the time of immunizations.  After immunizations, patient only said one word until March 2017 and did not get back to taking a few steps independently or using 2-3 words until March 2017.  Patient also started sleeping about 20 hours per day through December and January.
Age: 1.0
Sex: F
Vaccine: DTAPIPVHIB, FLUX, PNC13
Symptoms: Rash, Rash macular, Red blood cell count normal, Red blood cell morphology normal, Red cell distribution width normal
Clinical narrative: Patient had diarrhea from date of immunizations until 11/27, when she vomited several times in one hour with bloody mucus until bile.  Patient had been able to eat a certain formula and 5 safe foods without difficulty before immunizations and after immunizations, is unable to tolerate any foods at this time (April 2017).  Patient had blotchy facial rash and some facial swelling with each formula feeding for several weeks after which have resolved.  Also, patient had been taking a few steps independently and had a couple of words at the time of immunizations.  After immunizations, patient only said one word until March 2017 and did not get back to taking a few steps independently or using 2-3 words until March 2017.  Patient also started sleeping about 20 hours per day through December and January.
Age: 1.0
Sex: F
Vaccine: DTAPIPVHIB, FLUX, PNC13
Symptoms: Swelling face, Vomiting, White blood cell count normal
Clinical narrative: Patient had diarrhea from date of immunizations until 11/27, when she vomited several times in one hour with bloody mucus until bile.  Patient had been able to eat a certain formula and 5 safe foods without difficulty before immunizations and after immunizations, is unable to tolerate any foods at this time (April 2017).  Patient had blotchy facial rash and some facial swelling with each formula feeding for several weeks after which have resolved.  Also, patient had been taking a few steps independently and had a couple of words at the time of immunizations.  After immunizations, patient only said one word until March 2017 and did not get back to taking a few steps independently or using 2-3 words until March 2017.  Patient also started sleeping about 20 hours per day through December and January.
Age: 16.0
Sex: M
Vaccine: DTAPIPV, FLU4, HEPA, HPV9
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Patient was given KINRIX instead of MENACTRA on 04/07/17 around 11:30AM. Followed up with family on 04/11/17 and no adverse events reported.