chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse and refers to a patient of unknown age and gender. Information on medical history, past drugs, concurrent conditions and concomitant medications were not reported. The nurse reported that on 16-AUG-2017, the patient was vaccinated with PROQUAD (Lot # L047305, Expiry date: 23-MAY-2017), (dose, frequency were not provided) for prophylaxis which was expired on 23-MAY-2017 (Expired product administered). Nurse stated that the PROQUAD did not have any temperature excursions prior to administration. No adverse symptoms were reported. No further information was provided. No product quality complaint (PQC) was found. Outcome of events was unknown.
Sex: M
Vaccine: HPV9
Symptoms: Injection site rash
Clinical narrative: This spontaneous report as received from a physician via company representative concerning a 16 year old male patient. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On an unknown date, the patient was vaccinated with GARDASIL 9 (dosing details, lot#, expiry date were unknown) dose 2 at 2 month interval via intramuscular route for prophylaxis. On an unknown date, the patient experienced rash at injection site. The patient visited the doctor's office. No treatment was given for the event. No lab tests were performed. The patient did not visit the hospital. Therapy with GARDASIL 9 was continued. The outcome of injection site rash was reported as recovered/resolved on an unknown date. The reporter did not provide the causality between rash at injection site and GARDASIL 9. There were no product quality complaints (PQC) involved.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report as received from a physician via company representative and refers to a 14 year old female adolescent patient. Information on medical history, past drugs, concurrent conditions and concomitant medications were not provided. On 22-JUN-2016, the patient was vaccinated with GARDASIL 9 one dose, once in the left arm for prevention of human papilloma viral infection (HPV). After receiving the first dose, patient experienced dramatic injection site redness and swelling. The patient recovered on an unspecified date. The patient was presented at the physician's office at present for a physical examination and also to find out if she should get a second dose of GARDASIL 9. The patient has not had a second dose of GARDASIL 9 at this time. No additional adverse event information was available. Sought to medical attention was yes. No lab diagnostics were performed. Patient did not receive any treatment. No product quality compliant (PQC) was involved. The reporter did not report the causal relation of event with respect to GARDASIL 9.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a pharmacist refers to a unspecified patient of unknown age. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with improperly stored dose of ZOSTAVAX 19400 PFU, lot# N009167 with expiry: 02-FEB-2018, for prophylaxis. Concomitant included MERCK STERILE DILUENT. No adverse effect reported. The vaccine was stored at 6° F to 14° F for 45 minutes. It had no previous temperature excursion and the excursion was detected by digital data logger.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse prescriber refers to multiple unspecified patients of unknown age. The patients' medical history, concomitant medication and concurrent conditions were not reported. On an unknown dates, the patients were vaccinated with improperly stored dose of PNEUMOVAX23 from lot # M018766 with expiry: 15-OCT-2017, for prophylaxis. No adverse effect reported. The vaccine was stored at 47° F to 77° F for 11 hours. It also had previous temperature excursion and the excursion was detected by digital data logger.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse refers to unspecified patients of unknown age. The patients' medical history, concomitant medication and concurrent conditions were not reported. Since 09-MAR-2017, the patients had been vaccinated with improperly stored doses of GARDASIL 9, from lot # M034780, expiry: 15-APR-2019 and lot# M042853, expiry: 17-JUL-2019, for prophylaxis. No adverse effect reported. The vaccine was exposed to -4.4 degree Celsius for 1,057 hours (44 days) and 9 degree Celsius to 25 degree Celsius for 2 hours. The call was due to data logger. This is one of four reports received from the same reporter. Sender's Comments: US-009507513-1708USA007863: US-009507513-1708USA007864: US-009507513-1708USA007865.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse refers to unspecified patients of unknown age. The patients' medical history, concomitant medication and concurrent conditions were not reported. Since 09-MAR-2017, the patients had been vaccinated with improperly stored doses of M-M-R II from lot # M036544, expiry: 05-AUG-2018, lot# N008366; expiry: 13-MAR-2019 and lot# N009799, expiry: 24-MAR-2019, for prophylaxis. No adverse effect reported. The vaccine was exposed to -4.4 degree Celsius for 1, 057 hours (44 days) and 9 degree Celsius to 25 degree Celsius for 2 hours. The call was due to data logger.   This is one of four reports received from the same reporter.; Sender's Comments:  US-009507513-1708USA007831:
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse refers to unspecified patients of unknown age. The patients' medical history, concomitant medication and concurrent conditions were not reported. Since 09-MAR-2017, the patients had been vaccinated with improperly stored doses of PNEUMOVAX23 from lot # M038359 with expiry: 13-MAY-2018, for prophylaxis. No adverse effect reported. The vaccine was exposed to -4.4 degree Celsius for 1, 057 hours (44 days) and 9 degree Celsius to 25 degree Celsius for 2 hours. The call was due to data logger. This is one of four reports received from same reporter. Sender's Comments: US-009507513-1708USA007831.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Ear pruritus, Eye pruritus, Lethargy, Nausea, Pruritus
Clinical narrative: Patient experienced nausea/vomiting and lethargy approximately 10 minutes following vaccination. 15 minutes after vaccination, patient began to experience itching beginning around his neck, which quickly spread to the ears, eyes, legs, and throat. Patient did not have trouble speaking. Vital signs taken, age appropriate dose of Zyrtec administered. Patient was then evaluated by the pediatrician while a second set of vital signs were obtained. Patient then transferred to the ER for further evaluation. Patient did not required an Epi-Pen administration and walked to the ER one his own while escorted by a RN and parent.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Throat irritation, Vomiting
Clinical narrative: Patient experienced nausea/vomiting and lethargy approximately 10 minutes following vaccination. 15 minutes after vaccination, patient began to experience itching beginning around his neck, which quickly spread to the ears, eyes, legs, and throat. Patient did not have trouble speaking. Vital signs taken, age appropriate dose of Zyrtec administered. Patient was then evaluated by the pediatrician while a second set of vital signs were obtained. Patient then transferred to the ER for further evaluation. Patient did not required an Epi-Pen administration and walked to the ER one his own while escorted by a RN and parent.
Age: 20.0
Sex: M
Vaccine: SMALL
Symptoms: Injection site injury, Injection site irritation, Injection site pruritus, Injection site vesicles, Post vaccination autoinoculation
Clinical narrative: Pt hit smallpox while in shower on the wall and the scab tore off. Pt cross-inoculated self with 6-7 identifiable locations. Pt has severe itching, bandaid irritation and localized blisters around the smallpox sites.
Age: 17.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Abdominal pain, Arthralgia, Diarrhoea, Feeling cold, Headache
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of diarrhea in a 17-year-old female patient who received BEXSERO. On 2nd August 2017 16:00, the patient received the 2nd dose of BEXSERO. On 2nd August 2017 16:30, 30 min after receiving BEXSERO, the patient experienced diarrhea. On 3rd August 2017, the patient experienced fever, joint pain, hives and injection site tingling. In August 2017, the patient experienced feeling cold, vomiting, nausea, muscle spasm and abdominal pain. On 3rd August 2017, the outcome of the vomiting, nausea, muscle spasm and abdominal pain were recovered/resolved. On an unknown date, the outcome of the diarrhea, feeling cold, fever, joint pain, hives and injection site tingling were unknown. The reporter considered the diarrhea, feeling cold, vomiting, nausea, muscle spasm, abdominal pain, fever, joint pain, hives and injection site tingling to be possibly related to BEXSERO. Additional details were reported as follows: This case was reported by the medical assistant on behalf of the physician. On 2nd August 2017, at 4 PM, the patient received BEXSERO. After 30 minutes of vaccination reported as immediately, the patient developed diarrhea. The next morning, the patient was feeling very cold (latency of less than a day) and at 4 AM (latency of hours after vaccination), the patient vomited, had nausea, muscle spasms and abdominal pain that lasted to 1 pm. One day after vaccination, the patient had temperature was 101 degrees F. She had joint pain in her knees, elbows and hips. She developed hives on her arms and back and tingling at the injection site of her arm.
Age: 17.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Muscle spasms, Nausea, Paraesthesia, Pyrexia, Rash
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of diarrhea in a 17-year-old female patient who received BEXSERO. On 2nd August 2017 16:00, the patient received the 2nd dose of BEXSERO. On 2nd August 2017 16:30, 30 min after receiving BEXSERO, the patient experienced diarrhea. On 3rd August 2017, the patient experienced fever, joint pain, hives and injection site tingling. In August 2017, the patient experienced feeling cold, vomiting, nausea, muscle spasm and abdominal pain. On 3rd August 2017, the outcome of the vomiting, nausea, muscle spasm and abdominal pain were recovered/resolved. On an unknown date, the outcome of the diarrhea, feeling cold, fever, joint pain, hives and injection site tingling were unknown. The reporter considered the diarrhea, feeling cold, vomiting, nausea, muscle spasm, abdominal pain, fever, joint pain, hives and injection site tingling to be possibly related to BEXSERO. Additional details were reported as follows: This case was reported by the medical assistant on behalf of the physician. On 2nd August 2017, at 4 PM, the patient received BEXSERO. After 30 minutes of vaccination reported as immediately, the patient developed diarrhea. The next morning, the patient was feeling very cold (latency of less than a day) and at 4 AM (latency of hours after vaccination), the patient vomited, had nausea, muscle spasms and abdominal pain that lasted to 1 pm. One day after vaccination, the patient had temperature was 101 degrees F. She had joint pain in her knees, elbows and hips. She developed hives on her arms and back and tingling at the injection site of her arm.
Age: 17.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Urticaria, Vomiting
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of diarrhea in a 17-year-old female patient who received BEXSERO. On 2nd August 2017 16:00, the patient received the 2nd dose of BEXSERO. On 2nd August 2017 16:30, 30 min after receiving BEXSERO, the patient experienced diarrhea. On 3rd August 2017, the patient experienced fever, joint pain, hives and injection site tingling. In August 2017, the patient experienced feeling cold, vomiting, nausea, muscle spasm and abdominal pain. On 3rd August 2017, the outcome of the vomiting, nausea, muscle spasm and abdominal pain were recovered/resolved. On an unknown date, the outcome of the diarrhea, feeling cold, fever, joint pain, hives and injection site tingling were unknown. The reporter considered the diarrhea, feeling cold, vomiting, nausea, muscle spasm, abdominal pain, fever, joint pain, hives and injection site tingling to be possibly related to BEXSERO. Additional details were reported as follows: This case was reported by the medical assistant on behalf of the physician. On 2nd August 2017, at 4 PM, the patient received BEXSERO. After 30 minutes of vaccination reported as immediately, the patient developed diarrhea. The next morning, the patient was feeling very cold (latency of less than a day) and at 4 AM (latency of hours after vaccination), the patient vomited, had nausea, muscle spasms and abdominal pain that lasted to 1 pm. One day after vaccination, the patient had temperature was 101 degrees F. She had joint pain in her knees, elbows and hips. She developed hives on her arms and back and tingling at the injection site of her arm.
Age: 17.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Abdominal pain, Arthralgia, Diarrhoea, Feeling cold, Injection site paraesthesia
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of diarrhea in a 17-year-old female patient who received BEXSERO. On 2nd August 2017 16:00, the patient received the 2nd dose of BEXSERO. On 2nd August 2017 16:30, 30 min after receiving BEXSERO, the patient experienced diarrhea. On 3rd August 2017, the patient experienced fever, joint pain, hives and injection site tingling. In August 2017, the patient experienced feeling cold, vomiting, nausea, muscle spasm and abdominal pain. On 3rd August 2017, the outcome of the vomiting, nausea, muscle spasm and abdominal pain were recovered/resolved. On an unknown date, the outcome of the diarrhea, feeling cold, fever, joint pain, hives and injection site tingling were unknown. The reporter considered the diarrhea, feeling cold, vomiting, nausea, muscle spasm, abdominal pain, fever, joint pain, hives and injection site tingling to be possibly related to BEXSERO. Additional details were reported as follows: This case was reported by the medical assistant on behalf of the physician. On 2nd August 2017, at 4 PM, the patient received BEXSERO. After 30 minutes of vaccination reported as immediately, the patient developed diarrhea. The next morning, the patient was feeling very cold (latency of less than a day) and at 4 AM (latency of hours after vaccination), the patient vomited, had nausea, muscle spasms and abdominal pain that lasted to 1 pm. One day after vaccination, the patient had temperature was 101 degrees F. She had joint pain in her knees, elbows and hips. She developed hives on her arms and back and tingling at the injection site of her arm.
Age: 17.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Muscle spasms, Nausea, Pyrexia, Urticaria, Vomiting
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of diarrhea in a 17-year-old female patient who received BEXSERO. On 2nd August 2017 16:00, the patient received the 2nd dose of BEXSERO. On 2nd August 2017 16:30, 30 min after receiving BEXSERO, the patient experienced diarrhea. On 3rd August 2017, the patient experienced fever, joint pain, hives and injection site tingling. In August 2017, the patient experienced feeling cold, vomiting, nausea, muscle spasm and abdominal pain. On 3rd August 2017, the outcome of the vomiting, nausea, muscle spasm and abdominal pain were recovered/resolved. On an unknown date, the outcome of the diarrhea, feeling cold, fever, joint pain, hives and injection site tingling were unknown. The reporter considered the diarrhea, feeling cold, vomiting, nausea, muscle spasm, abdominal pain, fever, joint pain, hives and injection site tingling to be possibly related to BEXSERO. Additional details were reported as follows: This case was reported by the medical assistant on behalf of the physician. On 2nd August 2017, at 4 PM, the patient received BEXSERO. After 30 minutes of vaccination reported as immediately, the patient developed diarrhea. The next morning, the patient was feeling very cold (latency of less than a day) and at 4 AM (latency of hours after vaccination), the patient vomited, had nausea, muscle spasms and abdominal pain that lasted to 1 pm. One day after vaccination, the patient had temperature was 101 degrees F. She had joint pain in her knees, elbows and hips. She developed hives on her arms and back and tingling at the injection site of her arm.
Sex: F
Vaccine: MMR
Symptoms: Erythema, Skin warm
Clinical narrative: This spontaneous report as received from a other health professional refers to a 20 year old female patient with allergy to penicillin, sulfonamide, AUGMENTIN, BIAXIN and doxycycline. The patient did not take any concomitant medications and had no pertinent medical history. On 02-AUG-2017, the patient was vaccinated with M-M-R II lot # M042846, expiration date 21-OCT-2018 (dose, route of administration and anatomical location were not reported) reconstituted with sterile diluent (manufacturer unknown) lot# M046371, expiration date 06-JUL-2019 (dose, route and anatomical location were not reported) for immunization for college. Other suspect therapies included tuberculin purified protein derivative ("PPD test") in her right arm. On 02-AUG-2017 (reported as "within a few hours of leaving the office"), the patient's arm became red and warm to touch, and "got worse over the next 2 days". On 04-AUG-2017, the patient was seen by the physician and her right arm was "red and warm to touch" during the visit. She was prescribed clindamycin for the events. Follow up call was made to the patient on 08-AUG-2017 and the patient reported, that she "was doing fine". The relatedness between the events and the suspect therapies was not reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a registered nurse 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 PROQUAD, therapy type: recombinant human album, lot # M036158, expiration date 12-FEB-2018 (dose and route of administration were not reported). The vaccine was reconstituted with properly stored sterile diluent (lot number and expiration date were unknown). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion between 6 degrees Fahrenheit and 14 degrees Fahrenheit (also reported as 6.4 degrees Fahrenheit) for 2 hours. Data logger was involved. The vaccine experienced previous temperature excursion between 6 degrees Fahrenheit and 14 degrees Fahrenheit (also reported as 6.4 degrees Fahrenheit) for 30 minutes.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Rash vesicular
Clinical narrative: Information was received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was inoculated with ZOSTAVAX (lot number, dosage, and route of administration not provided) at a pharmacy on or about 09-OCT-2013, as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 30-NOV-2015, the patient was treated by a physician for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. The patient has been prescribed gabapentin and SILVADENE for management of her painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information has been received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was inoculated with ZOSTAVAX (lot number, dosage, and route of administration not provided) on or about 11-DEC-2012, at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 29-DEC-2014, the patient was treated by a physician for the onset of a severe vesicular eruption accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. The patient has been prescribed gabapentin and VALTREX for management of her painful breakouts. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On 16-AUG-2017 the patient was vaccinated with ZOSTAVAX lot # M041510 for prophylaxis. Other suspect therapies included STERILE DILUENT. On 16-AUG-2017, 1 day after onset of therapy the patient experienced expired product administered. On an unknown date the patient experienced no adverse event. The outcome of expired product administered and no adverse event is unknown. The reporter considered no adverse event to be not related to ZOSTAVAX and STERILE DILUENT. The reporter considered expired product administered to be not related to STERILE DILUENT and ZOSTAVAX. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician and refers to a 12-month-old female patient. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On 16-AUG-2017, the patient was vaccinated with an improperly stored dose of VARIVAX lot # N001527 with expiration date on 13-JAN-2019 (dose and route of administration was not reported). A properly stored dose of MERCK STERILE DILUENT (dose, route of administration, lot number and expiration date were not reported) was used to reconstitute the dose of the vaccine. There was no adverse effect reported. The administered dose of the vaccine experienced the temperature excursion of 6 to 14 degrees Fahrenheit for 1 hour and 47 minutes. There were no previous excursions reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a female patient of unknown age. No information regarding the patient's medical history and concurrent conditions was provided. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX subcutaneous injection (dose, lot number and expiration date were not reported). The vaccine was reconstituted with MERCK STERILE DILUENT. On an unknown date the patient experienced erythema at the injection site. The patient did not recover from the event at the time of the report. The relatedness between the event and ZOSTAVAX was not reported. Additional information is not expected as there was no consent for further contact.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive
Clinical narrative: This spontaneous report was received from a 22-year-old female patient reporting on herself. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. In approximately 2006 (at the age of 11), the patient was vaccinated with three subsequent doses in month 0, 2 and 6 of GARDASIL intramuscular injection (dose, lot number and expiration date were not reported) as a protection from human papilloma virus (HPV). On an unknown date, the patient was tested positive for HPV type 16. The patient did not report if she had any symptoms or diagnosis nor if she sought for medical attention after having the test results. The outcome of the event was unknown. The relatedness between the event and GARDASIL was not reported. Additional information is not expected as no contact details were provided.
Age: 21.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site pain, Nausea, Neck pain, Pain, Tenderness
Clinical narrative: Initial unsolicited report received from a nurse (patient's parent) on 08-AUG-2017. This case involves a 21-year-old male patient who was vaccinated with a dose of MENACTRA (batch number: U5514AB, expiry date, dose, dose in series and route of administration were not reported) in the left deltoid on 24-JUL-2017. Patient's medical history as pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) and illness at the time of vaccination were reported as none. Concomitant medications were not reported. On 24-JUL-2017 at evening, following the vaccination, the patient's left side of neck began to feel achy. On 25-JUL-2017, in the next morning, following the vaccination, the achiness progressed to Left shoulder and swelling noted Left side of neck, and neck was tender to touch and the patient began to feel overall body aches and nausea as day went on. It was reported that the patient was previously vaccinated with three doses of MENACTRA. The patient's Lab test was reported as none. As corrective treatment, the patient took Advil, and used warm compress to neck. The patient was recovered from all the events (reported as symptoms persisted for 3 days). List of documents held by sender: none.
Age: 39.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain
Clinical narrative: Arm pain at site of injection. Taking ibuprofen for pain. Applying ice and heat.
Age: 22.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Localised oedema
Clinical narrative: Localized redness, and swelling.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Back pain, Blood glucose normal, Blood test normal, Cold sweat, Computerised tomogram normal
Clinical narrative: Patient felt back pain initially, then was light headed and sweating and clammy She then fainted (did not hit her head) and was unconscious for about 20 seconds. EMT's arrived, and checked her out, Blood pressure, blood glucose and vital signs were normal at that time and they transported her to local hospital. Follow up with blood tests and CAT scan a the hospital were normal per hospital nurse. She was kept over night for observation and following up with echo-cardiogram today. Both the nurse at the hospital and patient's husband said she is feeling fine now, just awaiting ECHO test.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Dizziness, Hyperhidrosis, Loss of consciousness, Syncope
Clinical narrative: Patient felt back pain initially, then was light headed and sweating and clammy She then fainted (did not hit her head) and was unconscious for about 20 seconds. EMT's arrived, and checked her out, Blood pressure, blood glucose and vital signs were normal at that time and they transported her to local hospital. Follow up with blood tests and CAT scan a the hospital were normal per hospital nurse. She was kept over night for observation and following up with echo-cardiogram today. Both the nurse at the hospital and patient's husband said she is feeling fine now, just awaiting ECHO test.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Fall, Head injury, Loss of consciousness
Clinical narrative: Patient passed out, fell off of exam table and hit her head. Pt came to after a 40 seconds. Neuro and vital check completed - normal. All results normal. Adv'd to return to go to ER if needed.
Age: 37.0
Sex: M
Vaccine: MMR
Symptoms: Pruritus, Urticaria
Clinical narrative: Hives all over body. Pt states they were itchy, initially thought he  had gotten into Poison Ivy. Pt proceeded to take hot shower and then cold shower and used Calamine Lotion. Pt states total reaction lasted approximately 1.5 days.
Sex: F
Vaccine: TDAP
Symptoms: Oral mucosal blistering, Oral mucosal eruption
Clinical narrative: Presented with rash and blisters in mouth.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Dermatitis bullous, Rash
Clinical narrative: Patient did not have any reaction at the injection site, however, she did have hive like rash down her left arm and on her upper left neck (the side of the injection).
Age: 54.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Urticaria
Clinical narrative: WELTS, REDNESS, AND SWELLING TO INJECTION UPPER ARM.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13
Symptoms: No adverse event
Clinical narrative: Pt. waited 10-15 min no reaction. VIS given.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to multiple unspecified patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # M017983. No adverse effects were reported. The digital data logger was involved in recording the temperature excursion. This is one of six reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1708USA005166: US-009507513-1708USA005167: US-009507513-1708USA005169: US-009507513-1708USA005170: US-009507513-1708USA005168.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 07-AUG-2017, the patient was vaccinated with the expired dose of M-M-R II (for prophylaxis, lot # L027432, expiration date 22-JUL-2017), that was reconstituted with  sterile diluent. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
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 patient's medical history or concurrent conditions was provided. On 08-AUG-2017, the patients were vaccinated with improperly stored doses of ROTATEQ injection with lot number: M039661 and expiry date: 28-APR-2018 (exact dose, route of administration, were not reported) for prophylaxis. The vaccine was reconstituted with sterile diluent (lot number and expiration date not reported). There were no concomitant therapies reported. The administered doses of the vaccine were exposed to a temperature between 47 degrees Fahrenheit to 77 degrees Fahrenheit on an unspecified date, for a time frame of 16 hours. A digital data logger was not involved. There were no previous temperature excursions recorded. No adverse experiences were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Lot number M039661 is an invalid lot number for rotavirus vaccine, live, oral, pentavalent vaccine. Sender's Comments: US-009507513-1708USA004174: US-009507513-1708USA005225.
Sex: U
Vaccine: HPV9
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report has been received from a medical assistant, concerning an unspecified patient of unknown age and gender. On an unknown date, the patient was vaccinated with the first dose GARDASIL and on 24-AUG-2016, received the second dose. Furthermore, on 14-AUG-2017, the patient received as the third dose GARDASIL 9 lot number N000326 and expiration date 14-OCT-2019 for prophylaxis. No adverse effects reported. There was no product quality complaint involved.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information has been received on 15-AUG-2017 regarding a case in litigation from a lawyer and a male patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported. The patient was inoculated with ZOSTAVAX (lot number and expiration not reported) subcutaneous in 2010, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. Shortly after receiving the vaccine, the patient was treated for the onset of a severe vesicular eruption accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Immune system disorder, Pain, Rash vesicular, Vaccination failure
Clinical narrative: Information has been received on 15-AUG-2017 regarding a case in litigation from a lawyer and a female patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported. The patient was inoculated with ZOSTAVAX (lot number and expiration not reported) subcutaneous on or about 08-JAN-2013, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 24-MAR-2014, the patient was treated by a physician at a physician's office for the onset of a severe vesicular eruption accompanied by weakened immune symptoms, which was diagnosed as herpes zoster. The patient has been prescribed Acyclovir for management of her painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Age: 0.17
Sex: M
Vaccine: HIBV, PNC13, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On 29-JUN-2017 the patient was vaccinated with ROTATEQ lot # M031802, oral for prophylaxis. Concomitant therapies included PREVNAR 13 and HIB CONJ VACCINE (UNSPECIFIED CARRIER). On an unknown date the patient experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to ROTATEQ. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1707USA006507.
Age: 3.0
Sex: F
Vaccine: MMRV
Symptoms: Varicella post vaccine, Varicella virus test
Clinical narrative: This spontaneous report as received from a physician refers to a female patient of unknown age. On 20-AUG-2013, the patient was vaccinated with VARIVAX lot # J003700, expiry date: 27-MAR-2015 subcutaneous for prophylaxis. On 16-AUG-2016 the patient was vaccinated with PROQUAD lot # M010475, expiry date: 31-OCT-2018 subcutaneous for prophylaxis. On an unknown date the patient experienced varicella. The patient was treated with acyclovir, an antiviral, (brand and manufacturer unspecified) for 5 days (date unspecified). A sample was currently being checked at lab to verify chickenpox. The outcome of varicella was reported as not recovered/not resolved. Causality was unknown.
Sex: U
Vaccine: HPV9
Symptoms: Vomiting
Clinical narrative: This spontaneous report was received from a medical assistant via company representative refers to a patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date the patient was vaccinated with GARDASIL 9 (strength, dose, frequency, route of administration, lot number and expiry date were not reported) for prophylaxis. On 14-AUG-2017, the patient was throwing up. Outcome of vomiting was unknown. The reporter did not provide the causality assessment between the event and GARDASIL 9.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified number of patients' of unknown demographics. On unknown date(s), the patients' were vaccinated with improperly stored doses of M-M-R II (lot # M045391, expiry date: 14-NOV-2018) (subcutaneous route) reconstituted with STERILE WATER DILUENT (details not reported) for prophylaxis. The doses were stored at a temperature of 0 to 1 degree Centigrade (1.2 C) for 34 minutes. There was no previous temperature excursion. The call was because of the data logger. No adverse effects reported. No Product Quality Complaint (PQC) was involved. This is one of the several reports received from the same reporter. Sender's Comments:  US-009507513-1708USA007422: US-009507513-1708USA007425: US-009507513-1708USA007438: US-009507513-1708USA007441.
Sex: M
Vaccine: VARZOS
Symptoms: Anxiety, Back pain, Emotional distress, Facial pain, Headache
Clinical narrative: Information was received 16-AUG-2017 from a lawyer regarding a case in litigation concerning a male plaintiff of unspecified age.  It was alleged that on 21-JAN-2013 the plaintiff received ZOSTAVAX for its intended purpose: the prevention of shingles. On 13-AUG-2014 the plaintiff was diagnosed with shingles. The shingles began as a sharp pain in the center of his back, and then spread to the right side of his face and head. It was alleged that the plaintiff continues to experience pain and severe headaches and requires constant medication. He developed scars on his face and was diagnosed with nerve damage. It was alleged that as a direct and proximate result of ZOSTAVAX, the plaintiff's symptoms have resulted in physical limitations not present prior to receiving the product. The plaintiff also experiences mental and emotional distress due to resulting physical limitations from the seriousness of his condition. It was alleged that the plaintiff sustained severe and permanent personal injuries and he suffered serious, progressive, permanent and incurable injuries as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life and physical impairment and injury. The events of diagnosed with shingles began as sharp pain in center of his neck then spread to right side of face and head, diagnosed with nerve damage, scars on face, and continues to experience pain and severe headaches and requires constant medication were considered disabling. Additional information was requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Injury, Nerve injury, Physical disability, Quality of life decreased
Clinical narrative: Information was received 16-AUG-2017 from a lawyer regarding a case in litigation concerning a male plaintiff of unspecified age.  It was alleged that on 21-JAN-2013 the plaintiff received ZOSTAVAX for its intended purpose: the prevention of shingles. On 13-AUG-2014 the plaintiff was diagnosed with shingles. The shingles began as a sharp pain in the center of his back, and then spread to the right side of his face and head. It was alleged that the plaintiff continues to experience pain and severe headaches and requires constant medication. He developed scars on his face and was diagnosed with nerve damage. It was alleged that as a direct and proximate result of ZOSTAVAX, the plaintiff's symptoms have resulted in physical limitations not present prior to receiving the product. The plaintiff also experiences mental and emotional distress due to resulting physical limitations from the seriousness of his condition. It was alleged that the plaintiff sustained severe and permanent personal injuries and he suffered serious, progressive, permanent and incurable injuries as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life and physical impairment and injury. The events of diagnosed with shingles began as sharp pain in center of his neck then spread to right side of face and head, diagnosed with nerve damage, scars on face, and continues to experience pain and severe headaches and requires constant medication were considered disabling. Additional information was requested.
Sex: M
Vaccine: VARZOS
Symptoms: Scar
Clinical narrative: Information was received 16-AUG-2017 from a lawyer regarding a case in litigation concerning a male plaintiff of unspecified age.  It was alleged that on 21-JAN-2013 the plaintiff received ZOSTAVAX for its intended purpose: the prevention of shingles. On 13-AUG-2014 the plaintiff was diagnosed with shingles. The shingles began as a sharp pain in the center of his back, and then spread to the right side of his face and head. It was alleged that the plaintiff continues to experience pain and severe headaches and requires constant medication. He developed scars on his face and was diagnosed with nerve damage. It was alleged that as a direct and proximate result of ZOSTAVAX, the plaintiff's symptoms have resulted in physical limitations not present prior to receiving the product. The plaintiff also experiences mental and emotional distress due to resulting physical limitations from the seriousness of his condition. It was alleged that the plaintiff sustained severe and permanent personal injuries and he suffered serious, progressive, permanent and incurable injuries as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life and physical impairment and injury. The events of diagnosed with shingles began as sharp pain in center of his neck then spread to right side of face and head, diagnosed with nerve damage, scars on face, and continues to experience pain and severe headaches and requires constant medication were considered disabling. Additional information was requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacy technician, who referred to a patient of unknown demographics. On 17-AUG-2017, the patient was vaccinated with the expired dose of PNEUMOVAX23 lot # M007769 and expiry date of 27-JUN-2017 (indication defaulted to prophylaxis; dose and route of administration were not reported). The patient experienced no adverse effects. No product quality complaint was involved. The outcome of expired product administered and no adverse event was unknown. The reporter considered expired product administered and no adverse event to be not related to PNEUMOVAX23. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to patients of unknown age. On unknown dates the patients were vaccinated with VAQTA for prophylaxis. On unknown dates the patients experienced incorrect product storage. No adverse event was reported. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage to be not related to VAQTA. The reporter considered no adverse event to be not related to VAQTA. Additional information has been requested. Sender's Comments: US-009507513-1708USA008108: US-009507513-1708USA008109.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On unknown dates the patient were vaccinated with RECOMBIVAX HB for prophylaxis. On unknown dates the patients experienced incorrect product storage. No adverse event was reported. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage to be not related to RECOMBIVAX HB. The reporter considered no adverse event to be not related to RECOMBIVAX HB. Additional information has been requested. Sender's Comments: US-009507513-1708USA008033.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to patients of unknown age. On unknown dates the patient were vaccinated with GARDASIL 9 for prophylaxis. On unknown dates the patients experienced incorrect product storage. No adverse event was reported. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage to be not related to GARDASIL 9. The reporter considered no adverse event to be not related to GARDASIL 9. Additional information has been requested. Sender's Comments: US-009507513-1708USA008033.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Swelling, redness, warm skin.
Age: 0.08
Sex: F
Vaccine: DTAPIPVHIB, HIBV, PNC13, RV1
Symptoms: Extra dose administered
Clinical narrative: Pentacel given along with a dose of Hib.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Aphasia, Asthenia, Blood lactic acid increased, Conversion disorder, Dyskinesia
Clinical narrative: influenza (nasal spray) and Mencn - ACYW were administered at same time as second dose of HPV Vaccine. November 2014 -  Legs start to tremble during sports.  January 10, 2015 - legs still trembling, low energy, and not feeling good. Advised doctor. Doctor asked for video of leg trembles. May 7 2015 - 3rd and final dose of HPV Vaccine administered. June 4 2015 - legs trembling anytime exercising, lot of muscle pain and run down. Doctor refers to pediatric neurology after seeing video of abnormal leg movement.  June 5, 2015 - Neurology advised unknown Muscle Disease. Summer 2015 - arms and legs start trembling with no exercise. Doctor runs more test - lactic acid levels high. Ran test three times. April 2106 - leg movements become more severe.  Neurologist diagnosed Functional Neurological Disorder with unknown trauma. Patient currently has Movement Disorder involves legs, arms, back, neck, facial muscles, and throat. Limbs can stop working and has loss of speech. Patient has several daily seizures, low energy, and unclear thinking.