chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: HPV9, HPV9, HPV4, HPV9
Symptoms: Blood test, Electrocardiogram, Fatigue, Feeling abnormal, Headache
Clinical narrative: This spontaneous report was received from a consumer (patient's mother) regarding her daughter of currently 25 years old by next week. The patient was not pregnant. Patient's pertinent medical history was reported as none. The patient had no drug allergies or reactions. On 30-DEC-2017, the patient was vaccinated with only one dose of GARDASIL 9 (strength, Lot # and expiry date was not reported) for prophylaxis. Concomitant therapies included YAZ birth control off label as treatment for acne. The reporter stated that, her daughter experienced bad adverse effects since the administration GARDASIL 9. On 03-JAN-2018, the patient fainted while cleaning. At the time of this report, the patient was at college and had seen an unspecified physician "three times" since beginning to experience adverse effects. On an unknown date in January 2018, the patient developed headaches and had difficulty with her eyes focus. The patient found it very difficult or not possible to go to class due to the adverse effects and was "ready to withdraw from university" because of the adverse effects. It was reported that, the patient was "completely healthy" before receiving GARDASIL 9 and had "all other routine vaccinations" without any problems. The patient had not received any specific treatment for the adverse effects yet, but she had several tests, including blood work and blood pressure tests performed. The outcome of the events vision blurred, headache and syncope was reported as not recovered/not resolved. The reporter did not provide the causality assessment for the events. Product quality complaint (PQC) was not involved. Upon internal review, the event "Syncope" was considered to be serious due to disability (since the patient was "ready to withdraw from university").
Sex: F
Vaccine: HPV9, HPV9, HPV4, HPV9
Symptoms: Loss of personal independence in daily activities, Malaise, Syncope, Vision blurred
Clinical narrative: This spontaneous report was received from a consumer (patient's mother) regarding her daughter of currently 25 years old by next week. The patient was not pregnant. Patient's pertinent medical history was reported as none. The patient had no drug allergies or reactions. On 30-DEC-2017, the patient was vaccinated with only one dose of GARDASIL 9 (strength, Lot # and expiry date was not reported) for prophylaxis. Concomitant therapies included YAZ birth control off label as treatment for acne. The reporter stated that, her daughter experienced bad adverse effects since the administration GARDASIL 9. On 03-JAN-2018, the patient fainted while cleaning. At the time of this report, the patient was at college and had seen an unspecified physician "three times" since beginning to experience adverse effects. On an unknown date in January 2018, the patient developed headaches and had difficulty with her eyes focus. The patient found it very difficult or not possible to go to class due to the adverse effects and was "ready to withdraw from university" because of the adverse effects. It was reported that, the patient was "completely healthy" before receiving GARDASIL 9 and had "all other routine vaccinations" without any problems. The patient had not received any specific treatment for the adverse effects yet, but she had several tests, including blood work and blood pressure tests performed. The outcome of the events vision blurred, headache and syncope was reported as not recovered/not resolved. The reporter did not provide the causality assessment for the events. Product quality complaint (PQC) was not involved. Upon internal review, the event "Syncope" was considered to be serious due to disability (since the patient was "ready to withdraw from university").
Sex: F
Vaccine: HPV9, HPV9, HPV4, HPV9
Symptoms: Blood test, Headache, Loss of personal independence in daily activities, Syncope, Vision blurred
Clinical narrative: This spontaneous report was received from a consumer (patient's mother) regarding her daughter of currently 25 years old by next week. The patient was not pregnant. Patient's pertinent medical history was reported as none. The patient had no drug allergies or reactions. On 30-DEC-2017, the patient was vaccinated with only one dose of GARDASIL 9 (strength, Lot # and expiry date was not reported) for prophylaxis. Concomitant therapies included YAZ birth control off label as treatment for acne. The reporter stated that, her daughter experienced bad adverse effects since the administration GARDASIL 9. On 03-JAN-2018, the patient fainted while cleaning. At the time of this report, the patient was at college and had seen an unspecified physician "three times" since beginning to experience adverse effects. On an unknown date in January 2018, the patient developed headaches and had difficulty with her eyes focus. The patient found it very difficult or not possible to go to class due to the adverse effects and was "ready to withdraw from university" because of the adverse effects. It was reported that, the patient was "completely healthy" before receiving GARDASIL 9 and had "all other routine vaccinations" without any problems. The patient had not received any specific treatment for the adverse effects yet, but she had several tests, including blood work and blood pressure tests performed. The outcome of the events vision blurred, headache and syncope was reported as not recovered/not resolved. The reporter did not provide the causality assessment for the events. Product quality complaint (PQC) was not involved. Upon internal review, the event "Syncope" was considered to be serious due to disability (since the patient was "ready to withdraw from university").
Sex: F
Vaccine: HPV9, HPV9, HPV4, HPV9
Symptoms: Fatigue, Feeling abnormal, Laboratory test normal, Muscular weakness, Syncope
Clinical narrative: This spontaneous report was received from a consumer (patient's mother) regarding her daughter of currently 25 years old by next week. The patient was not pregnant. Patient's pertinent medical history was reported as none. The patient had no drug allergies or reactions. On 30-DEC-2017, the patient was vaccinated with only one dose of GARDASIL 9 (strength, Lot # and expiry date was not reported) for prophylaxis. Concomitant therapies included YAZ birth control off label as treatment for acne. The reporter stated that, her daughter experienced bad adverse effects since the administration GARDASIL 9. On 03-JAN-2018, the patient fainted while cleaning. At the time of this report, the patient was at college and had seen an unspecified physician "three times" since beginning to experience adverse effects. On an unknown date in January 2018, the patient developed headaches and had difficulty with her eyes focus. The patient found it very difficult or not possible to go to class due to the adverse effects and was "ready to withdraw from university" because of the adverse effects. It was reported that, the patient was "completely healthy" before receiving GARDASIL 9 and had "all other routine vaccinations" without any problems. The patient had not received any specific treatment for the adverse effects yet, but she had several tests, including blood work and blood pressure tests performed. The outcome of the events vision blurred, headache and syncope was reported as not recovered/not resolved. The reporter did not provide the causality assessment for the events. Product quality complaint (PQC) was not involved. Upon internal review, the event "Syncope" was considered to be serious due to disability (since the patient was "ready to withdraw from university").
Sex: F
Vaccine: HPV9, HPV9, HPV4, HPV9
Symptoms: Visual impairment, White blood cell count increased
Clinical narrative: This spontaneous report was received from a consumer (patient's mother) regarding her daughter of currently 25 years old by next week. The patient was not pregnant. Patient's pertinent medical history was reported as none. The patient had no drug allergies or reactions. On 30-DEC-2017, the patient was vaccinated with only one dose of GARDASIL 9 (strength, Lot # and expiry date was not reported) for prophylaxis. Concomitant therapies included YAZ birth control off label as treatment for acne. The reporter stated that, her daughter experienced bad adverse effects since the administration GARDASIL 9. On 03-JAN-2018, the patient fainted while cleaning. At the time of this report, the patient was at college and had seen an unspecified physician "three times" since beginning to experience adverse effects. On an unknown date in January 2018, the patient developed headaches and had difficulty with her eyes focus. The patient found it very difficult or not possible to go to class due to the adverse effects and was "ready to withdraw from university" because of the adverse effects. It was reported that, the patient was "completely healthy" before receiving GARDASIL 9 and had "all other routine vaccinations" without any problems. The patient had not received any specific treatment for the adverse effects yet, but she had several tests, including blood work and blood pressure tests performed. The outcome of the events vision blurred, headache and syncope was reported as not recovered/not resolved. The reporter did not provide the causality assessment for the events. Product quality complaint (PQC) was not involved. Upon internal review, the event "Syncope" was considered to be serious due to disability (since the patient was "ready to withdraw from university").
Sex: F
Vaccine: HPV9, HPV9, HPV4, HPV9
Symptoms: Abdominal pain upper, Anxiety, Arthralgia, Chest X-ray, Condition aggravated
Clinical narrative: This spontaneous report was received from a consumer (patient's mother) regarding her daughter of currently 25 years old by next week. The patient was not pregnant. Patient's pertinent medical history was reported as none. The patient had no drug allergies or reactions. On 30-DEC-2017, the patient was vaccinated with only one dose of GARDASIL 9 (strength, Lot # and expiry date was not reported) for prophylaxis. Concomitant therapies included YAZ birth control off label as treatment for acne. The reporter stated that, her daughter experienced bad adverse effects since the administration GARDASIL 9. On 03-JAN-2018, the patient fainted while cleaning. At the time of this report, the patient was at college and had seen an unspecified physician "three times" since beginning to experience adverse effects. On an unknown date in January 2018, the patient developed headaches and had difficulty with her eyes focus. The patient found it very difficult or not possible to go to class due to the adverse effects and was "ready to withdraw from university" because of the adverse effects. It was reported that, the patient was "completely healthy" before receiving GARDASIL 9 and had "all other routine vaccinations" without any problems. The patient had not received any specific treatment for the adverse effects yet, but she had several tests, including blood work and blood pressure tests performed. The outcome of the events vision blurred, headache and syncope was reported as not recovered/not resolved. The reporter did not provide the causality assessment for the events. Product quality complaint (PQC) was not involved. Upon internal review, the event "Syncope" was considered to be serious due to disability (since the patient was "ready to withdraw from university").
Sex: F
Vaccine: HPV9, HPV9, HPV4, HPV9
Symptoms: Confusional state, Dizziness, Echocardiogram, Electrocardiogram, Electrocardiogram ambulatory
Clinical narrative: This spontaneous report was received from a consumer (patient's mother) regarding her daughter of currently 25 years old by next week. The patient was not pregnant. Patient's pertinent medical history was reported as none. The patient had no drug allergies or reactions. On 30-DEC-2017, the patient was vaccinated with only one dose of GARDASIL 9 (strength, Lot # and expiry date was not reported) for prophylaxis. Concomitant therapies included YAZ birth control off label as treatment for acne. The reporter stated that, her daughter experienced bad adverse effects since the administration GARDASIL 9. On 03-JAN-2018, the patient fainted while cleaning. At the time of this report, the patient was at college and had seen an unspecified physician "three times" since beginning to experience adverse effects. On an unknown date in January 2018, the patient developed headaches and had difficulty with her eyes focus. The patient found it very difficult or not possible to go to class due to the adverse effects and was "ready to withdraw from university" because of the adverse effects. It was reported that, the patient was "completely healthy" before receiving GARDASIL 9 and had "all other routine vaccinations" without any problems. The patient had not received any specific treatment for the adverse effects yet, but she had several tests, including blood work and blood pressure tests performed. The outcome of the events vision blurred, headache and syncope was reported as not recovered/not resolved. The reporter did not provide the causality assessment for the events. Product quality complaint (PQC) was not involved. Upon internal review, the event "Syncope" was considered to be serious due to disability (since the patient was "ready to withdraw from university").
Sex: F
Vaccine: HPV9, HPV9, HPV4, HPV9
Symptoms: Fatigue, Feeling abnormal, Hypertension, Joint injury, Loss of consciousness
Clinical narrative: This spontaneous report was received from a consumer (patient's mother) regarding her daughter of currently 25 years old by next week. The patient was not pregnant. Patient's pertinent medical history was reported as none. The patient had no drug allergies or reactions. On 30-DEC-2017, the patient was vaccinated with only one dose of GARDASIL 9 (strength, Lot # and expiry date was not reported) for prophylaxis. Concomitant therapies included YAZ birth control off label as treatment for acne. The reporter stated that, her daughter experienced bad adverse effects since the administration GARDASIL 9. On 03-JAN-2018, the patient fainted while cleaning. At the time of this report, the patient was at college and had seen an unspecified physician "three times" since beginning to experience adverse effects. On an unknown date in January 2018, the patient developed headaches and had difficulty with her eyes focus. The patient found it very difficult or not possible to go to class due to the adverse effects and was "ready to withdraw from university" because of the adverse effects. It was reported that, the patient was "completely healthy" before receiving GARDASIL 9 and had "all other routine vaccinations" without any problems. The patient had not received any specific treatment for the adverse effects yet, but she had several tests, including blood work and blood pressure tests performed. The outcome of the events vision blurred, headache and syncope was reported as not recovered/not resolved. The reporter did not provide the causality assessment for the events. Product quality complaint (PQC) was not involved. Upon internal review, the event "Syncope" was considered to be serious due to disability (since the patient was "ready to withdraw from university").
Sex: F
Vaccine: HPV9, HPV9, HPV4, HPV9
Symptoms: Malaise, Palpitations, Syncope
Clinical narrative: This spontaneous report was received from a consumer (patient's mother) regarding her daughter of currently 25 years old by next week. The patient was not pregnant. Patient's pertinent medical history was reported as none. The patient had no drug allergies or reactions. On 30-DEC-2017, the patient was vaccinated with only one dose of GARDASIL 9 (strength, Lot # and expiry date was not reported) for prophylaxis. Concomitant therapies included YAZ birth control off label as treatment for acne. The reporter stated that, her daughter experienced bad adverse effects since the administration GARDASIL 9. On 03-JAN-2018, the patient fainted while cleaning. At the time of this report, the patient was at college and had seen an unspecified physician "three times" since beginning to experience adverse effects. On an unknown date in January 2018, the patient developed headaches and had difficulty with her eyes focus. The patient found it very difficult or not possible to go to class due to the adverse effects and was "ready to withdraw from university" because of the adverse effects. It was reported that, the patient was "completely healthy" before receiving GARDASIL 9 and had "all other routine vaccinations" without any problems. The patient had not received any specific treatment for the adverse effects yet, but she had several tests, including blood work and blood pressure tests performed. The outcome of the events vision blurred, headache and syncope was reported as not recovered/not resolved. The reporter did not provide the causality assessment for the events. Product quality complaint (PQC) was not involved. Upon internal review, the event "Syncope" was considered to be serious due to disability (since the patient was "ready to withdraw from university").
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Insomnia, Pain in extremity
Clinical narrative: The participant believed the nurse administered the shot too high up on her arm. They said the shot burned more than normal at the time of injection. The participants has had problems since the shot. The arm ached fro about 2 weeks after the shot, then started to become more painful. The participant has had trouble sleeping because of the pain. The participant has seen doctors and physical therapists for the issue. A Quest medical director has reached out the participant and referred her back to her personal physician and gave information on the National Vaccine Injury Compensation Program.
Age: 20.0
Sex: F
Vaccine: HEP
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from licensed practical nurse via a company representative, and refers to a 20 year female patient. Information regarding the patient's current conditions, medical history, concomitant medications and drug reactions/allergies was not provided. On 30-JUN-2017, the patient was vaccinated with a pediatric dose of RECOMBIVAX HB (dose number, route of administration, anatomical location, lot number and expiration date were not reported) for prophylaxis. No adverse event reported. On 19-DEC-2017, a telephone call was received from Licensed Practical Nurse reported that there were no additional issues reported by the patient and requests no additional contact. No further information is available.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Patient's information on m edical history, concurrent condiitions and concomitant therapies was not reported. On 29-NOV-2017, the patient was vaccinated with RECOMBIVAX HB lot # N009802, expiration date 19-DEC-2019, intramuscular (dose number was not provided) for prophylaxis. The pharmacist reported that, previous to administration, a temperature excursion happened: 11.3°C for 4 hours were data logged. The reporter sated that no previous temperature excursions happened before. The pharmacist did not report any adverse events. This is one of two reports received from the same reporter.; Sender's Comments: US-009507513-1712USA013995:
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Patient's information on medical history, concurrent conditions and concomitant therapies was not reported. On 30-NOV-2017, the patient was vaccinated with RECOMBIVAX HB lot # N009802, expiration date 19-DEC-2019, intramuscular (dose number was not provided) for prophylaxis. The pharmacist reported that, previous to administration, a temperature excursion happened: 11.3°C for 4 hours were data logged. The reporter stated that no previous temperature excursions happened before. The pharmacist did not report any adverse events. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1712USA009299.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 19-DEC-2013 the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) 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 31-JAN-2016 the patient was treated at a medical center for the onset of severe vesicular rash accompanied by a weakened immune symptoms, which was diagnosed as severe herpes zoster. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As 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: HPVX
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a female patient of unknown age refers to herself. In 2008, the patient received first dose of an unspecified human papillomavirus (HPV) vaccine (manufacturer unknown). She received the second dose three months after the first dose and the third dose two years after the second dose. No adverse event was reported.
Sex: F
Vaccine: HPV4
Symptoms: Headache, Muscular weakness, Syncope, Urinary incontinence
Clinical narrative: This spontaneous report was received from Physician Assistant via company representative referring to an adolescent female patient of unknown age (reported as "14 or 15"). The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported. On an unknown date, the patient was vaccinated with GARDASIL, intramuscular (dose, frequency, anatomical location, lot # and expiration date were unknown) for prophylaxis.  On the other hand, it was also reported other suspect therapy, an unspecified birth control that was given to the patient at the same time she received the vaccine. On an unknown date, (reported as "within a few weeks"),  the patient experienced headaches, syncope, muscle weakness, incontinence, and was unable to control her bladder, so she was treated at a hospital. At the time of the report, the outcome of muscular weakness, headache, syncope and urinary incontinence was reported as not recovered. Muscular weakness, headache, syncope and urinary incontinence were determined as disabling by the reporter.
Sex: M
Vaccine: HPVX
Symptoms: Complex regional pain syndrome, Walking aid user, Wheelchair user
Clinical narrative: This spontaneous report as received from a physician, via company representative, refers to a male patient of unknown age (who is also the physician's son). Patient's pertinent information on medical history, concurrent conditions and concomitant therapies was not provided. On 29-SEP-2016, the patient was vaccinated with an unidentified Merck HPV vaccine. Patient received either a dose of GARDASIL 9, 0.5 ml once (route of administration, lot number and expiration date were not reported) or a dose of GARDASIL 0.5 ml once (route of administration, lot number and expiration date were not reported), both to prevent HPV (Human Papilloma Virus). On an unknown date in 2016, after receiving the vaccine, the patient experienced complex regional pain syndrome (CRPS). On 08-OCT-2016, the patient needed to use a wheelchair. He was, at the reporting time, able to walk with a cane but "on bad days", the patient still needed to use a wheelchair, which the reporter considered a disability. The patient sought medical attention and received the physical therapy needed, reported as "236 visits to a physical therapy". It was unknown by the reporter if treatment was given for the adverse event. The physician also reported that there was a study done, where an unspecified number of people who received the vaccine, also developed complex regional pain syndrome (CRPS) (recorded in case # 703621). The outcome of the patient's complex regional pain syndrome (CRPS) was reported as recovering. The causality assessment between the patient's complex regional pain syndrome (CRPS) and the administered vaccine was not assessed. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1801USA005286.
Sex: M
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from the patient's mother and refers to a 22-year-old male patient. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. The patient was vaccinated with three subsequent doses of GARDASIL intramuscular injection (dose, lot number and expiration date were not reported) on November 2004, June 2014 and October 2017. No adverse effects were reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a nurse, referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions  were not reported. Concomitant therapies included sterile diluent (MERCK STERILE DILUENT) lot # N015977, expiration date on 20-MAY-2018 (properly stored). On 10-JAN-2018, the patient was vaccinated with a properly stored expired dose of VARIVAX lot # M000998, expiration date on 07-JAN-2018 (anatomical location and administration route were not reported) for prophylaxis. No adverse effects reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX lot # N019822, expiration date 13-JUL-2019, lot # N022983, expiration date 23-AUG-2019, (strength, dose, route and anatomical location were not provided) for prophylaxis. Concomitant therapies included sterile diluent. No adverse effects were reported. The vaccines were exposed to a temperature range between 15°F to 46°F (15.3°F), during a time frame of 167 hours, which was called by a data logger. No previous temperature excursions were reported.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's relevant medical history, drug reactions/allergies and concomitant medication were not reported. The medical assistant reported that on 18-DEC-2017 the patient received an improperly stored dose of GARDASIL 9 lot number: N017697 (expiration date: 21-JAN-2020), for prophylaxis (strength, route, dose or units were not provided). There was digital data logger involved. The storage characteristics were the following: - Temperature: 47 F to 77 F for 30 minutes. - Previous temperature excursion: at or above 32 F to 35 F for 7 hours. No adverse effects were reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1801USA005371: US-009507513-1801USA005372: US-009507513-1801USA005373:
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's relevant medical history, drug reactions/allergies and concomitant medication were not reported. The medical assistant reported that on 18-DEC-2017 the patient received an improperly stored dose of GARDASIL 9 lot number: N017697 (expiration date: 21-JAN-2020), for prophylaxis (strength, route, dose or units were not provided). There was digital data logger involved. The storage characteristics were the following: - Temperature: 47 F to 77 F for 30 minutes. - Previous temperature excursion: at or above 32 F to 35 F for 7 hours. No adverse effects were reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1801USA004525: US-009507513-1801USA005372: US-009507513-1801USA005373:
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's relevant medical history, drug reactions/allergies and concomitant medication were not reported. The medical assistant reported that on 18-DEC-2017 the patient received an improperly stored dose of GARDASIL 9 lot number: N017697 (expiration date: 21-JAN-2020), for prophylaxis (strength, route, dose or units were not provided). There was digital data logger involved. The storage characteristics were the following: - Temperature: 47 F to 77 F for 30 minutes. - Previous temperature excursion: at or above 32 F to 35 F for 7 hours. No adverse effects were reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1801USA004525: US-009507513-1801USA005371: US-009507513-1801USA005373:
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's relevant medical history, drug reactions/allergies and concomitant medication were not reported. The medical assistant reported that on 02-JAN-2018 the patient received an improperly stored dose of GARDASIL 9 lot number: N017697 (expiration date: 21-JAN-2020), for prophylaxis (strength, route, dose or units were not provided). There was digital data logger involved. The storage characteristics were the following: - Temperature: 47 F to 77 F for 30 minutes. - Previous temperature excursion: at or above 32 F to 35 F for 7 hours. No adverse effects were reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1801USA004525: US-009507513-1801USA005371: US-009507513-1801USA005372:
Sex: U
Vaccine: TDAP
Symptoms: Adverse event
Clinical narrative: Initial unsolicited report received from a Pharmacist on 05-Jan-2018. This case was considered as invalid case as no adverse event was reported. This case involves a patient with unknown demographics who was vaccinated with a dose of ADACEL (batch number, expiration date, dose, dose in series, route and site of administration were not reported) on an unspecified date. Medical history and concomitant medication were not reported. On an unknown date, following the vaccination, the patient experienced unspecified symptoms and required an Emergency Room visit. Laboratory investigations and corrective treatment were not reported. The outcome of the event was not reported. List of documents held by sender: none.
Age: 50.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site warmth
Clinical narrative: Approx 3 days after pt had PREVNAR administered she noted a large rash on R deltoid, red in color, hot to touch. Dr dictated this area was pruritic erythematous patch approx. 6cm x 4cm. Treated with doxycycline 100mg Take 1 tab by mouth twice daily for 5 days. Heart and lungs normal per physical assessment.
Age: 12.0
Sex: F
Vaccine: FLU4
Symptoms: Cough, Influenza virus test negative, Pyrexia, Streptococcus test negative
Clinical narrative: Onset of fever 102.5 and cough within hours of administration of flu vaccine. States something happened with administrate of 2016-2017 vaccine w/associated vomit at that time.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Arthralgia, Headache, Injection site rash, Pain
Clinical narrative: Patient states he feels achy, Joint pain, headaches and also rash at injection site. States he took ADVIL (OTC) for headaches and that resolved pain.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Influenza like illness, Injection site pain, Lymph node pain
Clinical narrative: Headache, chills, possible fever, body aches, pain at site of injection, pain in arm and glands under arm of injection site. Chills and fever lasted ~6hours - disrupting sleep first night. Headache lasted 24+ hours. Body aches, soreness around injection site and glands under arm lasted >48 hours. Recovering - but not completely over symptoms. Advil, rest, and fluids. Like a minor flu.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity, Pyrexia, Sleep disorder
Clinical narrative: Headache, chills, possible fever, body aches, pain at site of injection, pain in arm and glands under arm of injection site. Chills and fever lasted ~6hours - disrupting sleep first night. Headache lasted 24+ hours. Body aches, soreness around injection site and glands under arm lasted >48 hours. Recovering - but not completely over symptoms. Advil, rest, and fluids. Like a minor flu.
Age: 1.33
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Induration, Rash erythematous
Clinical narrative: Area of induration, with surrounding red rash. Prescribed mupirocin ointment and steroid.
Age: 18.0
Sex: M
Vaccine: UNK
Symptoms: Immediate post-injection reaction, Injection site pain, Injection site swelling
Clinical narrative: Immediate pain at site of injection. Pain got worse overnight and continued. Swelling at injection site lasted over 10 days.
Age: 17.0
Sex: F
Vaccine: YF
Symptoms: Feeling abnormal, Syncope
Clinical narrative: The patient presented to the pharmacy for Yellow Fever vaccine. She is traveling and was deemed a candidate for the vaccine. After receiving the vaccine, the patient stood up to go to the register and began "feeling funny."  The pharmacist had her sit down in the counseling area where she proceeded to faint. The pharmacy called 911 and the pharmacist checked her vitals. EMS arrived 5 minutes after calling and assessed the patient as having an episode of syncope related to getting an immunizations. They offered to take her to the Emergency Room, however recommended that it was not necessary. She agreed and went home to rest.
Sex: U
Vaccine: HIBV
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from medical assistant and from an employee from the same reporting institution, referring to a patient of unknown age and gender. The patient's medical history, drug reactions/allergies and concomitant medications were not provided. On 18-DEC-2017, the patient was vaccinated with one improperly stored dose of LIQUID PEDVAXHIB (lot # N027768, expiry date: 03-OCT-2019), for prophylaxis (dose and route of administration were not reported). The vaccine underwent a temperature from 47 Fahrenheit degrees (°F) to 77 °F by a time frame of 48 hours and 20 minutes, with no previous temperature excursion and with digital data logger involved, as reported by the medical assistant on 18-DEC-2017. On 27-DEC-2017, the employee reported that after further investigation it was determined they were in the safe range for up 72 hours, so it was not considered improperly stored.
Age: 14.0
Sex: F
Vaccine: HEP, HEPA, IPV, MMR, VARCEL
Symptoms: No adverse event, Product administered at inappropriate site
Clinical narrative: This spontaneous report as received from a pharmacy technician refers to a 14 year old female patient. On 20-DEC-2017, the patient was vaccinated for prophylaxis with VARIVAX lot # N022978, expiration date dose 1, subcutaneous into the abdomen - a site not specifically listed as acceptable. On the same date, the patient was vaccinated with VAQTA, M-M-R II, poliovirus vaccine inactivated (unspecified) and ENGERIX-B. Nothing out of the ordinary was noted. No adverse effects were reported.
Age: 50.0
Sex: F
Vaccine: FLUC4
Symptoms: Pain in extremity
Clinical narrative: Pain to RUE.
Age: 42.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Injection site pain, Musculoskeletal discomfort
Clinical narrative: Joint pain in the shoulder started a couple of days after the vaccination. Injection site pain persisted for several weeks after vaccination. Joint pain has subsided over time. Currently no joint pain if arm is at rest, however if I lift my arm I still have minor discomfort in the joint. It does not affect my ADLs, it is just nagging at this point.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Left shoulder pain after flu shot , started six weeks prior.
Age: 18.0
Sex: F
Vaccine: FLU3
Symptoms: Syncope
Clinical narrative: Fainted.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Rash (L) arm - ? Zoster shot. None in dermatome - Tx Acyclovir.
Age: 0.58
Sex: F
Vaccine: DTAPHEPBIP, HEP, HIBV, PNC13, RV1
Symptoms: Death, Toxicologic test
Clinical narrative: Infant Death.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Fall, Head injury, Loss of consciousness
Clinical narrative: Passed out; hit head during fall.
Age: 32.0
Sex: M
Vaccine: FLU4, TDAP
Symptoms: Rhinorrhoea, Sinus congestion, Urticaria
Clinical narrative: Patient experienced hives, head congestion and runny nose 4 days after receiving preservative free FLUZONE and Tdap vaccines.
Age: 3.0
Sex: F
Vaccine: FLU4, HEPAB
Symptoms: Wrong drug administered
Clinical narrative: The patient was supposed to receive  a flu (FLUARIX) vaccine, but she received a hep a-hep b (TWINRIX) vaccine. Then, when the error was discovered, the nurse called the patient's mother and explained the error and the patient returned to the clinic and received the flu vaccine. No injuries were sustained.
Age: 43.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Bursitis, Mobility decreased, Musculoskeletal pain, Pain, Pain in extremity
Clinical narrative: Within one hour arm and shoulder pain. Unable to lift arm above shoulder. Pain while trying to undress, lift objects and most of all during sleeping time. Treatment with NSAIDS, ice, moist heat, cortisone shot and no improvement. (Diagnose as Bursitis).
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: X-ray
Clinical narrative: Within one hour arm and shoulder pain. Unable to lift arm above shoulder. Pain while trying to undress, lift objects and most of all during sleeping time. Treatment with NSAIDS, ice, moist heat, cortisone shot and no improvement. (Diagnose as Bursitis).
Age: 9.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Pt received Flu inj on 10-30-17 in left deltoid. Pt had redness and swelling of approx 2-5" around inj site on 10-31-17. Redness and swelling became worse on 11-1-17, measured 6 in x 5 1/2 in. Pt was given BENADRYL and did ice packs overnight. Redness and swelling was better on 11-2-17. Prescribed hydroxyzine on 11-2-17.
Age: 0.08
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Dyspnoea, Rash macular, Skin discolouration, Tachypnoea
Clinical narrative: Patient became blotchy and tachypnic after vaccines. Provider perceived her to be dusky and not aerating well.
Age: 0.58
Sex: F
Vaccine: FLU4
Symptoms: Incorrect dose administered
Clinical narrative: Pt was given adult dose (0.5 ml). It should've been (0.25 ml).
Sex: U
Vaccine: HPV9
Symptoms: Extra dose administered, Interchange of vaccine products
Clinical narrative: This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. The patient's historical drugs, medical history, concomitant therapies, drugs allergies and concurrent conditions were not reported. On 10-JUL-2012, the patient completed the 3 dose series of GARDASIL for prophylaxis (strength, dose, route, frequency, lot # and expiration date were not reported). 18-DEC-2017, the patient was vaccinated with GARDASIL 9 4th dose, lot # N021571, expiration date 29-APR-2020, for prophylaxis (strength, dose and frequency were not reported).
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 12-JAN-2018, the patient was vaccinated with an expired dose of ZOSTAVAX lot # M039452; expiry date 19-DEC-2017 (dose and route of administration were not provided). The ZOSTAVAX was reconstituted with sterile diluent. No adverse effect was reported.
Age: 73.0
Sex: F
Vaccine: PNC13
Symptoms: Pain, Pruritus, Skin irritation, Swelling
Clinical narrative: Patient started to experience swelling, itching, pain. The site of irritation has increased in size and has not decreased in 8 days. Patient was advised to use ibuprofen around the clock and benadryl.  She has continuously been using both with no alleviation. Instructed to consult physician as well and to continue both therapies until further notice.
Age: 43.0
Sex: F
Vaccine: FLU4, HEPAB
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: The patient presented to the clinic to receive a hep a-hep b (TWINRIX) vaccine. She received a flu (FLUARIX) vaccine instead. Then, when the error was discovered, the nurse called the patient and the patient returned to the clinic the same day and received a Twinrix vaccine. No injuries were sustained.
Age: 61.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site discolouration, Injection site mass, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: 2 inch painful swelling/lump in right deltoid that was hot and bruise colored; also  swollen lymph node in arm pit that lasted 5-6 days; lump currently still present (4 weeks later), but smaller (size of a penny) and not hot, painful, or bruise-colored. Know.
Age: 61.0
Sex: F
Vaccine: TDAP
Symptoms: Lymphadenopathy
Clinical narrative: 2 inch painful swelling/lump in right deltoid that was hot and bruise colored; also  swollen lymph node in arm pit that lasted 5-6 days; lump currently still present (4 weeks later), but smaller (size of a penny) and not hot, painful, or bruise-colored. Know.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain, Insomnia, Neck pain, Sleep disorder
Clinical narrative: Great pain in upper left arm area up to base of neck. Unable to sleep on left side. Only getting about 4 hours of sleep at night because of pain. Unable to lift left arm past shoulder.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia
Clinical narrative: Right foot presented with a strange numb feeling, when sock and shoe were off it felt as if I still had a tight sock on. Couldn't really feel light stimulation on foot. Within a week the sensation spread to halfway up my lower leg. Sensation lasted around 4 weeks then deminished.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Balance disorder, Computerised tomogram head normal, Coordination abnormal, Dizziness, Dysgraphia
Clinical narrative: Early onset dizziness x3days, then fatigue, loss of coordination, loss of balance and equilibrium. Fine motor skills affected also (typing and writing)...things I normally did with ease. Unable to work or drive for several weeks. Saw PCP and neurologist. Had CT brain, labs, EKG, and MRI brain all negative. Did PT for 4 weeks. Unable to get a diagnosis. Tried meclizine and 5 days of tapered steroids...neither helped symptoms. Slowly improving, but not 100% yet. Was a very healthy, active 56 year old who NEVER got sick, not got the flu shot until employer required it.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Electrocardiogram normal, Fatigue, Fine motor skill dysfunction, Impaired driving ability, Impaired work ability
Clinical narrative: Early onset dizziness x3days, then fatigue, loss of coordination, loss of balance and equilibrium. Fine motor skills affected also (typing and writing)...things I normally did with ease. Unable to work or drive for several weeks. Saw PCP and neurologist. Had CT brain, labs, EKG, and MRI brain all negative. Did PT for 4 weeks. Unable to get a diagnosis. Tried meclizine and 5 days of tapered steroids...neither helped symptoms. Slowly improving, but not 100% yet. Was a very healthy, active 56 year old who NEVER got sick, not got the flu shot until employer required it.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Laboratory test normal, Nuclear magnetic resonance imaging brain normal
Clinical narrative: Early onset dizziness x3days, then fatigue, loss of coordination, loss of balance and equilibrium. Fine motor skills affected also (typing and writing)...things I normally did with ease. Unable to work or drive for several weeks. Saw PCP and neurologist. Had CT brain, labs, EKG, and MRI brain all negative. Did PT for 4 weeks. Unable to get a diagnosis. Tried meclizine and 5 days of tapered steroids...neither helped symptoms. Slowly improving, but not 100% yet. Was a very healthy, active 56 year old who NEVER got sick, not got the flu shot until employer required it.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Pyrexia
Clinical narrative: High fever of 102.3 degrees Fahrenheit.
Age: 0.5
Sex: M
Vaccine: FLU4
Symptoms: Food allergy, Peripheral swelling
Clinical narrative: Leg swelled up the size of a grapefruit. Developed an egg allergy that he did not have before.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Initially pain, same day as vaccine given. Within 24 hours developed redness, tenderness and swelling at site.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Dizziness, Dysphagia, Dyspnoea, Palpitations
Clinical narrative: Pt. came for flu vaccine. Acknowledged has no known contraindications to the flu vaccine. VIS provided and wishes to proceed with the flu vaccine. After 5 minutes, pt c/o dizziness, heart palpitations, chest tightness, trouble swallowing, and a little SOB. Notified Dr. her primary MD. MD ordered Dipenhydramine 25mg IM, Aspirin 81mg 2 tabs PO recorded, EKG, BP check. Instructed to call 911. 911 arrived. Pt was alert and responsive and was taken by the Paramedics.
Age: 33.0
Sex: F
Vaccine: PPV
Symptoms: Chest X-ray, Chills, Condition aggravated, Injection site erythema, Laboratory test
Clinical narrative: Fever and chills within a couple hours. Ongoing for almost 3 days. Redness at injection site started about 48 hours after injection. The redness spread to almost the entire outside of the upper left arm. Treated fever with acetaminophen around the clock. An online doctor visit 36 hours after injection suggested the same. Went to emergency department 72 hours after injection. Doctors there treated infection empirically in addition to fluids, steroids and acetaminophen. Fever subsided. No source of infection found, so antibiotics stopped. Theory presented was SIRS, systemic inflammation response syndrome. Kidney function also affected adversely.
Age: 33.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia, Renal impairment, Systemic inflammatory response syndrome
Clinical narrative: Fever and chills within a couple hours. Ongoing for almost 3 days. Redness at injection site started about 48 hours after injection. The redness spread to almost the entire outside of the upper left arm. Treated fever with acetaminophen around the clock. An online doctor visit 36 hours after injection suggested the same. Went to emergency department 72 hours after injection. Doctors there treated infection empirically in addition to fluids, steroids and acetaminophen. Fever subsided. No source of infection found, so antibiotics stopped. Theory presented was SIRS, systemic inflammation response syndrome. Kidney function also affected adversely.