chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Syringe issue
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. Although the patient's gender was not provided it was reported that, the patient was not pregnant. On 01-JUL-2016, the patient was vaccinated with ZOSTAVAX (lot # L039126, expiration date: 08-JAN-2017, dose and injection site were not provided), subcutaneously. When the pharmacist was administering ZOSTAVAX most of the dose leaked out between the syringe and where the needle was attached. The pharmacist was not sure, if the patient received a full dose. No adverse effect was reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to a patient of unknown age and gender. Information regarding medical history, concurrent condition and concomitant medication was not provided. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (dose, lot# and expiration date unknown, once) intramuscularly by another pharmacist. No adverse effect were reported. Additional information has been requested.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Activities of daily living impaired, Gait disturbance, Lumbar puncture abnormal, Neuritis, Pain
Clinical narrative: This spontaneous report was received from a 77 year old male patient concerning himself who was coronary and had reactions/allergies to doxycycline hyclate, OXYCONTIN, VICODIN and codeine. The patient's medical history included blood clots, hernia and spinal surgery. In January 2014, at the recommendation of his former physician, the patient was vaccinated with a dose of ZOSTAVAX, 1 shot, subdermally (strength, lot number and expiration date were unknown). There were no concomitant therapies reported. The patient reported that he never had chickenpox prior to the vaccination and he tolerated the vaccine at first. However, in November 2014, he had a purple-reddish color rash from his knee up to his groin on his left leg and developed severe pain. As a result, the patient was rushed to the emergency room and was directed to wrap the affected area twice a day with an unspecified ointment. He reported that, on an unknown date, he spent seven months in a pain clinic and a spinal tap was done confirming that his nerves were inflamed and it was diagnosed a post herpetic neuralgia. He stated that he had been in and out of pain clinics, he had a new physician as he still had problems with his leg, difficulty walking and could not put on his shoes and socks by himself. Moreover, he had lost weight and also reported problems with sleep due to chronic pain. The patient was treated with OXYCONTIN, gabapentin, tramadol, diazepam, prednisone (manufacturer unknown), LYRICA, methadone, morphine, fentanyl, duloxetine, epidural shots and NUCYNTA. However, all prescribed medications had proven ineffective in managing his pain. The outcome of the aforementioned events was reported as not recovered. The causality between ZOSTAVAX and the events were not provided. This case is one of two reports from the same patient. Additional information has been requested.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Post herpetic neuralgia, Rash, Rash erythematous, Sleep disorder, Weight decreased
Clinical narrative: This spontaneous report was received from a 77 year old male patient concerning himself who was coronary and had reactions/allergies to doxycycline hyclate, OXYCONTIN, VICODIN and codeine. The patient's medical history included blood clots, hernia and spinal surgery. In January 2014, at the recommendation of his former physician, the patient was vaccinated with a dose of ZOSTAVAX, 1 shot, subdermally (strength, lot number and expiration date were unknown). There were no concomitant therapies reported. The patient reported that he never had chickenpox prior to the vaccination and he tolerated the vaccine at first. However, in November 2014, he had a purple-reddish color rash from his knee up to his groin on his left leg and developed severe pain. As a result, the patient was rushed to the emergency room and was directed to wrap the affected area twice a day with an unspecified ointment. He reported that, on an unknown date, he spent seven months in a pain clinic and a spinal tap was done confirming that his nerves were inflamed and it was diagnosed a post herpetic neuralgia. He stated that he had been in and out of pain clinics, he had a new physician as he still had problems with his leg, difficulty walking and could not put on his shoes and socks by himself. Moreover, he had lost weight and also reported problems with sleep due to chronic pain. The patient was treated with OXYCONTIN, gabapentin, tramadol, diazepam, prednisone (manufacturer unknown), LYRICA, methadone, morphine, fentanyl, duloxetine, epidural shots and NUCYNTA. However, all prescribed medications had proven ineffective in managing his pain. The outcome of the aforementioned events was reported as not recovered. The causality between ZOSTAVAX and the events were not provided. This case is one of two reports from the same patient. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Blood test, Eye irritation, Measles post vaccine, Oropharyngeal pain, Pyrexia
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 26 year old female patient. Patient had a history of asthma, migraines and headaches. She had no drug reactions or allergies. Patient had given birth. On 27-JUN-2016, the patient was vaccinated with a booster dose of M-M-R II (lot # L041457, expiry date #22/10/2017, therapy type recombinant human albumin (rHA)), at a dose of 0.5 ml, subcutaneously since the patient had low titre of rubella. Concomitant therapies included SINGULAIR, prenatal vitamins, TYLENOL for fever and pain and cephalexin. On 07-JUL-2016, the patient experienced fever, rash, sore throat and eye irritation. On 10-JUL-2016, the patient sought medical attention and was hospitalized. On 11-JUL-2016, the patient was diagnosed with measles. Unspecified blood tests were performed (in approximately July 2016) that were sent to a clinic and the 'CDC (Centre for Disease Control and Prevention) could get involved'. The outcome of measles was reported as not recovered. Causality assessment were not reported. No product quality complaint (PQC) was filed. The reporter considered the event to be serious due to hospitalization and disability. Upon internal review the event was considered to be medically significant. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Rash
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 26 year old female patient. Patient had a history of asthma, migraines and headaches. She had no drug reactions or allergies. Patient had given birth. On 27-JUN-2016, the patient was vaccinated with a booster dose of M-M-R II (lot # L041457, expiry date #22/10/2017, therapy type recombinant human albumin (rHA)), at a dose of 0.5 ml, subcutaneously since the patient had low titre of rubella. Concomitant therapies included SINGULAIR, prenatal vitamins, TYLENOL for fever and pain and cephalexin. On 07-JUL-2016, the patient experienced fever, rash, sore throat and eye irritation. On 10-JUL-2016, the patient sought medical attention and was hospitalized. On 11-JUL-2016, the patient was diagnosed with measles. Unspecified blood tests were performed (in approximately July 2016) that were sent to a clinic and the 'CDC (Centre for Disease Control and Prevention) could get involved'. The outcome of measles was reported as not recovered. Causality assessment were not reported. No product quality complaint (PQC) was filed. The reporter considered the event to be serious due to hospitalization and disability. Upon internal review the event was considered to be medically significant. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Blood test, Eye irritation, Measles, Oropharyngeal pain, Pyrexia
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 26 year old female patient. Patient had a history of asthma, migraines and headaches. She had no drug reactions or allergies. Patient had given birth. On 27-JUN-2016, the patient was vaccinated with a booster dose of M-M-R II (lot # L041457, expiry date #22/10/2017, therapy type recombinant human albumin (rHA)), at a dose of 0.5 ml, subcutaneously since the patient had low titre of rubella. Concomitant therapies included SINGULAIR, prenatal vitamins, TYLENOL for fever and pain and cephalexin. On 07-JUL-2016, the patient experienced fever, rash, sore throat and eye irritation. On 10-JUL-2016, the patient sought medical attention and was hospitalized. On 11-JUL-2016, the patient was diagnosed with measles. Unspecified blood tests were performed (in approximately July 2016) that were sent to a clinic and the 'CDC (Centre for Disease Control and Prevention) could get involved'. The outcome of measles was reported as not recovered. Causality assessment were not reported. No product quality complaint (PQC) was filed. The reporter considered the event to be serious due to hospitalization and disability. Upon internal review the event was considered to be medically significant. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, Mobility decreased, Oedema peripheral, Pain in extremity
Clinical narrative: c/o pain and difficulty of movement in fingers, hands, knees, ankles, and hips. Edema to the hands and fingers.
Age: 44.0
Sex: F
Vaccine: TD
Symptoms: Chills, Headache, Nausea, Pain
Clinical narrative: Constant headache, nausea, body aches, chills.
Age: 11.0
Sex: F
Vaccine: HPV9, MEN, TDAP
Symptoms: Blood glucose, Deafness, Dizziness, Dyskinesia, Haemoglobin
Clinical narrative: Patient felt faint/ pale in color and she stated she could not hear. Patient had a slight jerk of movement and had to be laid down. Lab test were normal.
Age: 11.0
Sex: F
Vaccine: HPV9, MEN, TDAP
Symptoms: Laboratory test normal, Pallor
Clinical narrative: Patient felt faint/ pale in color and she stated she could not hear. Patient had a slight jerk of movement and had to be laid down. Lab test were normal.
Age: 0.53
Sex: F
Vaccine: DTAPHEPBIP, PNC13
Symptoms: Body temperature increased
Clinical narrative: Rectal temperature of 104.1.
Age: 39.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Nausea, Pain, Tuberculin test positive, Vomiting
Clinical narrative: Initial unsolicited report received from a nurse on 14 June 2016. This case involves a 39-year-old female patient who was vaccinated with a dose of ADACEL (batch number: UI568AA, expiration date 16 June 2018 and dose were not reported) by intramuscular route in the left deltoid and dose of TUBERCULIN PPD (M) 5 TU (Tubersol) (Batch number: C4866A, expiration date 22 January 2018 and dose were not reported) by intradermal route in left forearm on 07 June 2016. Patient had no illness at time of vaccination. Pre-existing physician diagnosed allergies, birth defects included allergy to Keflex, penicillin, phenergan and medical conditions included hypertension. Concomitant medications were not reported. 08 June 2016, one day following the vaccination experienced mild symptoms of headache, nausea, vomiting and body aches. Patient went to emergency room on 12 July 2016. Laboratory investigations included Tuberculin skin tests which was positive. Corrective treatment were not reported. Patient was not recovered from event. It was reported that physician told that it was a reaction to the vaccine. List of documents held by sender: none.
Sex: M
Vaccine: YF
Symptoms: Axillary pain
Clinical narrative: Initial unsolicited report received from a nurse on 16 Jun 2016. This case is linked to 2016SA114797 (same reporter). This case involves a male patient (one of the two boys, age not reported) who was vaccinated with first dose of YELLOW FEVER VACCINE (lot number: UI291AA, expiration date: 20 Apr 2018, dose, route of administration not reported) in deltoid on 13 Jun 2016. The medical history including any allergies, illness at time of vaccination were reported as none. It was unknown whether the patient received any concomitant medications and if any other vaccine administered to the patient within 4 weeks of the suspect vaccine. On 14 Jun 2016, one day after vaccination, the patient experienced pain in the axilla. The reporter planned to advise the mother to take the patient to see their pediatrician and have them evaluated for their symptoms. It was reported that patient required doctor visit. The lab data was reported as none. Corrective treatment was not reported. The outcome for the events was reported as unknown. List of documents held by sender: none.
Age: 55.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Red, swollen, and warm to the touch around the injection site.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Patient's pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/allergies were reported. On 06-JUN-2016, the patient was vaccinated with improperly stored dose of GARDASIL 9 (lot # L043213, expiration date 28-AUG-2017) (strength, dosing details and anatomical location were not reported). No adverse effects were reported. No product quality complaint was involved. This is one of several reports reported by the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Patient's pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/allergies were reported. On 27-MAY-2016, the patient was vaccinated with improperly stored dose of GARDASIL 9 (lot # L043213, expiration date 28-AUG-2017) (strength, dosing details and anatomical location were not reported). No adverse effects were reported. No product quality complaint was involved. This is one of the several reports reported by the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Patient's pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/allergies were reported. On 07-JUN-2016, the patient was vaccinated with improperly stored dose of GARDASIL 9 (lot # L043213, expiration date 28-AUG-2017) (strength, dosing details and anatomical location were not reported). No adverse effects were reported. No product quality complaint was involved. This is one of the several reports reported by the same reporter. Additional information has been requested.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No pertinent medical history, drug reactions/allergies or concurrent conditions were reported. On 23-JUN-2016, ZOSTAVAX was improperly exposed to a temperature of 14.36 F for 1.5 hours. Then on unspecified date in 2016, the patient was vaccinated with a improperly stored dose of ZOSTAVAX subcutaneous lot # L039096, expiration date 08-JAN-2017 (dose, dose number and anatomical location were not reported). No concomitant medications were reported. No adverse events were reported. Additional information has been requested.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Diarrhoea, Dizziness, Headache, Nausea
Clinical narrative: Body aches, high fever, chills, diarrhea, headache, dizziness, nausea.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: Body aches, high fever, chills, diarrhea, headache, dizziness, nausea.
Age: 26.0
Sex: F
Vaccine: HEP
Symptoms: Amnesia, Computerised tomogram normal, Disorientation, Dizziness, Electrocardiogram normal
Clinical narrative: Grand Mal seizure (which has never happened before or since) disorientation that lasted weeks and frequent memory loss and dizziness that I am still plagued with today. Headaches.
Age: 26.0
Sex: F
Vaccine: HEP
Symptoms: Generalised tonic-clonic seizure, Headache, Nuclear magnetic resonance imaging normal
Clinical narrative: Grand Mal seizure (which has never happened before or since) disorientation that lasted weeks and frequent memory loss and dizziness that I am still plagued with today. Headaches.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Patient's pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/allergies were reported. On 16-JUN-2016, the patient was vaccinated with improperly stored dose of GARDASIL 9 (lot # L043213, expiration date 28-AUG-2017) (strength, dosing details and anatomical location were not reported). No adverse effects were reported. No product quality complaint was involved. This is one of the several reports reported by the same reporter. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Injection site rash, Rash vesicular, Scab
Clinical narrative: This spontaneous report as received from a physician, refers to approximately 30 year old female patient. The patient's medical history, concurrent condition and drug reactions/allergies were not reported (reported as none). Approximately on 07-JUN-2016 (reported as "around June 7th or 8th, 2016"), the patient was vaccinated with the first dose of VARIVAX (dose and lot# were not reported), subcutaneous. On 24-JUN-2016 (also reported as "approximately two weeks later"), the patient experienced varicella-like rash. Two weeks later after vaccination, the patient noticed a few rash lesions, one at the injection site, two on her forehead, one on her thigh, and one on the right side of he neck. The patient sought medical attention, she was examined by the reporting physician. Upon exam by the physician, appear crusted and scabbing over. No treatment was given. No labs diagnostics were performed. The patient reports no fever or other symptoms. At the time of report, the outcome of varicella-like rash was not reported. The relatedness between vaccination and varicella-like rash was not provided. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Patient's pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/allergies were reported. On 15-JUN-2016, the patient was vaccinated with improperly stored doses of GARDASIL 9 (lot # L043213, expiration 28-AUG-2017) (strength, dosing details and anatomical location were not reported). No adverse effects were reported. No product quality complaint was involved. This is one of the several reports received by the same reporter. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV9
Symptoms: Aplastic anaemia, Aspiration bone marrow, Decreased appetite, Dyspnoea, Haematology test abnormal
Clinical narrative: This spontaneous report was received from a registered nurse referring to a currently 16 years old female patient. The patient has none pertinent medical history, drug reactions or allergies reported. On 20-JAN-2016, the patient was vaccinated with the first dose of GARDASIL 9 (Lot # L019297, expiration date 18-AUG-2017) (route, anatomical location and dose were not provided). It was reported that this vaccine was the only one she had received since 2011. There was not concomitant medication reported. On 29-APR-2016, the patient's mother visited the office and stated that the patient did not feel well (malaise), her appetite was down (decreased appetite), she experienced weight loss and shortness of breath. The reporting nurse stated that a blood work was taken at time of office visit and results showed aplastic anemia, the patient was admitted to the hospital from 30-APR-2016 to 02-MAY-2016. The patient had received 2 transfusions, platelets and aspiration of bone marrow on unspecified dates since diagnosis and she had received many unspecified medications as part of the treatment, there were additional admissions to the hospital on 25-MAY-2016 and 19-JUN-2016. The nurse stated that additional doses of GARDASIL 9 had not been pursued, the patient had received many unspecified blood work completed. At the time of the report, the outcome of the adverse events was reported recovering/resolving (also reported as "the patient was doing better"). Upon internal review the adverse events were considered as serious adverse events (medically significant) due hospitalization and disability. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV9
Symptoms: Malaise, Platelet transfusion, Transfusion, Weight decreased
Clinical narrative: This spontaneous report was received from a registered nurse referring to a currently 16 years old female patient. The patient has none pertinent medical history, drug reactions or allergies reported. On 20-JAN-2016, the patient was vaccinated with the first dose of GARDASIL 9 (Lot # L019297, expiration date 18-AUG-2017) (route, anatomical location and dose were not provided). It was reported that this vaccine was the only one she had received since 2011. There was not concomitant medication reported. On 29-APR-2016, the patient's mother visited the office and stated that the patient did not feel well (malaise), her appetite was down (decreased appetite), she experienced weight loss and shortness of breath. The reporting nurse stated that a blood work was taken at time of office visit and results showed aplastic anemia, the patient was admitted to the hospital from 30-APR-2016 to 02-MAY-2016. The patient had received 2 transfusions, platelets and aspiration of bone marrow on unspecified dates since diagnosis and she had received many unspecified medications as part of the treatment, there were additional admissions to the hospital on 25-MAY-2016 and 19-JUN-2016. The nurse stated that additional doses of GARDASIL 9 had not been pursued, the patient had received many unspecified blood work completed. At the time of the report, the outcome of the adverse events was reported recovering/resolving (also reported as "the patient was doing better"). Upon internal review the adverse events were considered as serious adverse events (medically significant) due hospitalization and disability. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Induration on inection site 6x6cm, redness and warm to touch.
Age: 0.18
Sex: F
Vaccine: DTAP, RV1
Symptoms: Crying, Diarrhoea, Irritability, Lethargy, Pyrexia
Clinical narrative: Lethargy, diarrhea, vomiting, fussiness, crying, fever.
Age: 0.18
Sex: F
Vaccine: DTAP, RV1
Symptoms: Vomiting
Clinical narrative: Lethargy, diarrhea, vomiting, fussiness, crying, fever.
Age: 1.37
Sex: M
Vaccine: MMRV
Symptoms: Abnormal behaviour, Crying, Decreased eye contact, Listless, Pyrexia
Clinical narrative: Child has been persistently listless, crying, feverish to 103 degrees, with poor eye contact and different behaviors.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to a patient of unknown age and gender. No pertinent medical history, drug reactions/allergies or concurrent conditions were reported. On unspecified dates in 2015, the patient was vaccinated with the first and second dose of GARDASIL as recommended schedule at 0 months and 2 months (dose, route of administration, lot number and expiration date were not reported). Additionally, it was also stated that on 06-JUL-2016 (reported as "a little over a year, since the vaccination series was started"), the patient received the third dose of GARDASIL 0.5 ml, intramuscular, lot # L035105, expiration date 14-MAY-2017 (Anatomical location was not reported). No other suspect or concomitant therapies were reported. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a patient of unknown age and gender. No information about the patient's pertinent medical history, concomitant medications and drug reactions or allergies was reported. On 03-JUN-2016, the patient was inadvertently vaccinated with improperly stored GARDASIL 9 injection lot # L020015 with expiry date 16-AUG-2017 or lot # reported as L006546 with expiry date 27-NOV-2017 (dose, route of administration and anatomical location were not specified). No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information is not expected as there was no consent for further contact.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician referring to multiple unspecified patients of unknown age and gender. Concurrent and historical condition was not provided. On multiple unspecified dates, the patients were vaccinated with improperly stored PEDVAXHIB (lot # L030870 with expiration date 10-JUN-2018; dose and route unknown). Concomitant therapy was not provided. The physician reported there were no adverse effects. There was no previous excursion. The vaccine was exposed to 33.3F for 3 hours and 59.1F for 5 hours. Data logger was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician referring to multiple unspecified patients of unknown age and gender. Concurrent and historical condition was not provided. On multiple unspecified dates, the patients were vaccinated with improperly stored GARDASIL 9 (lot # L018351 with expiration date 11-AUG-2017; dose and route unknown). Concomitant therapy was not provided. The physician reported there were no adverse effects. There was no previous excursion. The vaccine was exposed to 33.3F for 3 hours and 59.1F for 5 hours. Data logger was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a pharmacist referring to an unspecified number of college students of unknown age and gender. Concomitant therapy was not provided. On an unknown date the patients were vaccinated with ZOSTAVAX (dose and route unknown) (confirmed not VARIVAX) as a requirement to entering an university. Concomitant therapy was not provided. No adverse symptoms reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to 6 patients of unknown age and gender. The patients' medical histories and concurrent conditions were not reported. On unknown dates the patients were vaccinated with improperly stored doses of ZOSTAVAX (lot# L044529, expiration date 09-FEB-2017, route not reported). Concomitant therapies were not reported. The vaccine was improperly stored at 36 degrees Fahrenheit for 8 hours. There was no previous temperature excursion. Data logger was not involved. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to an unspecified number of patients of unknown age and gender. Concurrent condition and medical history of the patients were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot # M004116, expiration date: 12-OCT-2017; lot# L018351, expiration date: 11-AUG-2017) (dose and route unspecified) (Incorrect storage of drug). No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 25-JAN-2016, the patient was vaccinated with first dose of GARDASIL 9. On 01-MAR-2016, patient received second dose of GARDASIL 9 (dose, frequency, route of administration and lot number were unspecified for both dosage regimens). No adverse effect reported. The outcome of the events was not reported. This is one of the two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to multiple unknown patients of unknown age and gender. Medical history, concurrent conditions and concomitant medication were not reported. On multiple unknown dates, patients were vaccinated with improperly stored (temperature: 1.3C, for 1 hour and 30 minutes, because of a "data logger") PNEUMOVAX 23 (Pre-Filled Syringes), lot # M005287, exp: 08-OCT-2017; lot # M000592, exp: 12-OCT-2017, (dose and frequency not reported). No adverse effects were reported. No previous temperature excursion was reported. The outcome of the events was unknown. No product quality complaint (PQC) was involved. This is one of three reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a physician referring to a patient of unknown age and gender. On an unknown date 3 weeks after the first dose of GARDASIL 9 administration, the patient was vaccinated with the second dose of GARDASIL 9 (dose, route, lot# and expiration date were not reported). (drug use for unapproved schedule). No adverse effect were reported. Additional information has been requested.
Age: 57.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist via company representative refers to a 57 year old male patient. The patient's pertinent medical history, drug allergies and concomitant medications were not reported. On an unknown date, the patient was vaccinated with PNEUMOVAX23 (lot #, expiration date, dose and route were not reported). The pharmacist reported the patient experienced an injection site reaction (redness, swelling and pain in the injection site) following administration of PNEUMOVAX23 on unspecified date. The outcome of the events was unknown. The causality was not provided. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to an unspecified number of patients of unknown age and gender. Concurrent condition and medical history of the patients were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of PEDVAXHIB (lot # reported as L051125, expiration date: 14-OCT-2018; lot# reported as M006710, expiration date: 06-DEC-2018) (dose and route unspecified). No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 8.0
Sex: M
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions/allergies were not reported. On 12-JUL-2016, the patient was vaccinated inadvertently with an expired PNEUMOVAX 23 (lot # L002310 with expiration date 08-JUL-2016; dose and route were not reported). No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to an unspecified number of patients. On an unknown date the patients were vaccinated with improperly stored RECOMBIVAX HB lot # M000442, expiration date 31-MAR-2018, and lot #L038018, expiration date 13-SEP-2017, (dose and route of administration were not provided). The RECOMBIVAX HB was stored in a temperature of 50.8 degrees F for a cumulative period of 38 hours. No adverse effects were reported for any patient. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Patient's pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/allergies were reported. On 15-JUN-2016, the patient was vaccinated with improperly stored dose of GARDASIL 9 (lot # L043213, expiration date 28-AUG-2017) (strength, dosing details and anatomical location were not reported). No adverse effects were reported. No product quality complaint was involved. This is one of the several reports reported by the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse regarding several patient's of unknown and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On an unspecified dates in 2016, the patients were vaccinated with improperly stored doses of VARIVAX (dose, route, lot # and expiration date were not reported). VARIVAX doses had been in freezer that had been out of range since 02-JAN-2016 according to the data logger. The temperature excursion was during 4416 hours (184 days). There was no adverse event reported. This is one of two reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to an unspecified patients of unspecified demographics. There was no information about the patients' medical history, concomitant therapies and concurrent conditions. On unknown multiple dates, the patients were vaccinated with improperly stored PROQUAD lot # L047305, expiration date 23-MAY-2017; lot # M004895, expiration date 26-JUL-2017 (strength, dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccine experience the temperature excursion of -12 degrees Celsius till an unknown duration. No data logger was involved. No product quality complaint was reported. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided. This is one of several reports received from the same reporter.
Age: 22.0
Sex: U
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker referring to a 22 year old patient of unknown gender. The patient's concurrent conditions and medical history were not reported. On 07-JUL-2016, the patient was inadvertently vaccinated with PROQUAD (Lot # L031601, expiration date 18-JUL-2018) dose, route, frequency were not provided. There was not concomitant medication reported. No adverse effect reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Patient's pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/allergies were reported. On 15-JUN-2016, the patient was vaccinated with improperly stored dose of GARDASIL 9 (lot # L043213, expirations date 28-AUG-2017) (strength, dosing details and anatomical location were not reported) (incorrect product storage). No adverse effects were reported. No product quality complaint was involved. This is one of the several reports reported by the same reporter. Additional information has been requested.
Age: 2.0
Sex: M
Vaccine: MMR
Symptoms: Autism
Clinical narrative: This spontaneous report was received from a registered nurse regarding a 5 year old male patient. The patient's current conditions and medical history were not reported. On 29-JUL-2000 (at the age of "2 years old"), the patient was vaccinated with first dose of M-M-R II (lot # 633097/0255K, expiry: 09-FEB-2002). Concomitant therapies included sertraline hydrochloride and clonazepam. On an unknown date in 2003 (reported as at the age of "5 years old"), the patient was diagnosed with autism. The outcome of the event was unknown. The reporter did not provide causal relationship between the event and suspect therapy. Upon internal review the event autism was considered as medically significant. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Pain, Skin warm, Sleep disorder, Swelling
Clinical narrative: Very painful (pt couldn't sleep), warm, slight swelling.
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Head injury, Loss of consciousness
Clinical narrative: After receiving immunizations patient stood and passed out hitting the back of her head on the floor, code blue was called after patient lost consciousness  x 30 seconds, open her eyes alert and oriented  x 3, vital signs B/P right arm 98/50 Pulse 76, resp 16. Continue to remain alert oriented x 3 with no complaints of neck pain, neck immobilize until EMD reported. EMD reported vital signs given patient remained alert oriented x 3 with no pain noted. Condition with be followed up.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, IPV, MMRV
Symptoms: Dry skin, Injection site eczema, Injection site pain, Injection site reaction, Tinea infection
Clinical narrative: Unsure of the exact onset. Patient complained of pain at injection site for 2 weeks after injection. Some time after the pain went away, there was a round eczema looking spot at the location of the injection. After watching the site for a month, with no changes, patient was taken to the Dr and treated for ringworm. With no changes noted after treatment, he returned to the Dr 2 weeks later, treated with topical steroids and a consult to dermatology was placed. Patient saw dermatology a month later, with no changes noted to the eczema site. Dermatology decided it was eczema and prescribed stronger topical steroid. At this time, his mother questioned if it could have been a reaction to one of his imms. Patient was treated with no change to the eczema spot. Once all topical steroids were stopped, the eczema spot healed. Now 6 months later, the area is still rough feeling but no longer red and itchy. The eczema spot was approx. 1/2 dollar size, located on the left thigh where the KINRIX was injected. After discussion at the Dr with the MA, it was determined which vaccine was placed where.
Age: 47.0
Sex: F
Vaccine: PNC13
Symptoms: Asthenia, Decreased appetite, Fatigue, Headache, Nausea
Clinical narrative: Patient calls clinic 2 days following vaccine - symptoms noted in VIS Nausea, Weakness, Decreased appetite, Fatigue, Headache.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Injection site erythema, Injection site swelling, Pain in extremity, Paraesthesia
Clinical narrative: Patient experienced redness and swelling around the injection site. She also complained of tingling and minor pains in her lower back down her left leg to her foot. No sign of a rash yet.
Age: 64.0
Sex: F
Vaccine: TDAP
Symptoms: Peripheral swelling
Clinical narrative: Patient called today at 2:45 pm, about 24 hours after receiving the vaccine. She stated her arm is somewhat swollen "about halfway down to her elbow". I am unsure of exact time of onset.
Age: 58.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Asthenia, Dizziness, Fatigue, Hypoaesthesia
Clinical narrative: Could not get out of bed. Pains all-over, Joints, swollen upper arm of injection, dizzyness, fatigue, weakness - feeling like having the flu, numbness (even in face), stiffness all over. Feeling so bad, I had to call in sick at work.
Age: 58.0
Sex: F
Vaccine: TDAP
Symptoms: Impaired work ability, Influenza like illness, Injection site swelling, Mobility decreased, Musculoskeletal stiffness
Clinical narrative: Could not get out of bed. Pains all-over, Joints, swollen upper arm of injection, dizzyness, fatigue, weakness - feeling like having the flu, numbness (even in face), stiffness all over. Feeling so bad, I had to call in sick at work.
Age: 58.0
Sex: F
Vaccine: TDAP
Symptoms: Pain
Clinical narrative: Could not get out of bed. Pains all-over, Joints, swollen upper arm of injection, dizzyness, fatigue, weakness - feeling like having the flu, numbness (even in face), stiffness all over. Feeling so bad, I had to call in sick at work.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Arthralgia, Injection site pain, Pyrexia, Vomiting
Clinical narrative: Patient began complaining that her legs were hurting where the shots were given at about 2:00 pm on the date that she received the shots. That night she began running a fever of 102 degrees. At approximately 11:00pm that night she began vomiting. She continued to vomit several more times throughout the night. On the morning of July 8th, she no longer had a fever. However, that night she had a fever again of 102 degrees and complained of joint pain in her knees.
Age: 1.54
Sex: M
Vaccine: MMR
Symptoms: Head titubation, Motor dysfunction, Tremor
Clinical narrative: Shaking of arms and head, decline in gross motor skill function, all over body trembling that lasted approximately 24 hours.
Age: 55.0
Sex: F
Vaccine: PNC13
Symptoms: Bronchiectasis, Bronchitis, Computerised tomogram abnormal, Cough, Dyspnoea
Clinical narrative: Coughing, breathing problems, pain in left lung. Sought medical attention on May 9, 2016 2:30 and was treated for bronchitis. On May 17, 2016, Dr. diagnosed me with pneumonia in my left lung. I have permanent damage in that lung now-bronchiectasis.
Age: 55.0
Sex: F
Vaccine: PNC13
Symptoms: Pneumonia, Pulmonary pain
Clinical narrative: Coughing, breathing problems, pain in left lung. Sought medical attention on May 9, 2016 2:30 and was treated for bronchitis. On May 17, 2016, Dr. diagnosed me with pneumonia in my left lung. I have permanent damage in that lung now-bronchiectasis.
Age: 64.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site streaking, Injection site swelling
Clinical narrative: Severe left shoulder pain and swelling increasing in severity during the evening; swelling and pain started within 2 hours of given pneumonia vaccine; felt redness and streaking increased since last night ; no fever or chills; iced and placed heat on left shoulder without any relief.
Age: 0.18
Sex: M
Vaccine: 6VAX-F, PPV
Symptoms: Dyspnoea, Ear swelling, Peripheral swelling, Pharyngeal oedema, Restrictive pulmonary disease
Clinical narrative: Covered in hives from head to toe, severely swollen hands, ears, and throat. Restricted airway, difficulty breathing. Took to hospital emergency room. Was treated with ZANTAC and prednisone. Was released that evening and treated with medicine for next 24 hours and he had no further problems.
Age: 0.18
Sex: M
Vaccine: 6VAX-F, PPV
Symptoms: Urticaria
Clinical narrative: Covered in hives from head to toe, severely swollen hands, ears, and throat. Restricted airway, difficulty breathing. Took to hospital emergency room. Was treated with ZANTAC and prednisone. Was released that evening and treated with medicine for next 24 hours and he had no further problems.
Age: 30.0
Sex: F
Vaccine: HEPA
Symptoms: Dizziness, Hyperhidrosis, Pallor, Visual impairment
Clinical narrative: Administered vaccine HAVRIX 1 ml IM to left deltoid over 1 min. She got up and within 2 mi, pt stated that she "feels dizzy and seeing black spots." Assisted her back to sitting down on the chair and offered her to lay down on the exam table which she declined. She sat upright and closed her eyes for about 5 more minutes and noticed that she became pale and profusely diaphoretic but remained awake. Assisted her on to the examining table and had her laying flat, elevating her feet and legs by raising the head of the table. Her husband was here and went to get some bottled water. Immediately she began to feel better after laying in that position for about 20 min. Ice pack was given for her forehead which did help. Once she recovered, she sat up for 2 min drinking her bottled water and advised her to move slowly and not to make any sudden movements in the meantime. She was able to ambulate in the room without dizziness or unsteadiness. She felt better and was ok to leave the clinic with her husband.
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site nodule, Injection site pain, Injection site swelling
Clinical narrative: Arm extremely sore, red and swollen at the injection site. There is actually like a knot at the injection site.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site inflammation, Injection site swelling
Clinical narrative: Administration area and surrounding areas inflamed (red and swollen).
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: Redness, swelling and itching from the armpit down to the elbow.
Sex: U
Vaccine: HPV9
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender, who completed 3 dose series of GARDASIL on 24-JUL-2013, 26-AUG-2013 and 29-JAN-2014, respectively. On an unknown date in July 2016, the patient was inadvertently vaccinated with a dose of GARDASIL 9 (lot # L023230 with expired date 28-JUL-2017, dose and route were unknown. No adverse effect was reported. Additional information is not expected since the reporter refused further contact.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a patient of unknown age and gender. On an unknown date the patient was vaccinated with an expired dose of VARIVAX (dose unknown, lot # K002913, expiration date 26-FEB-2016). No adverse effect was reported. Additional information has been requested.
Age: 54.0
Sex: M
Vaccine: FLUX, MMR
Symptoms: Autoimmune disorder, Inflammation, Malaise, Musculoskeletal stiffness, Nodule
Clinical narrative: Auto immune reaction. Pain, stiffness, nodules on hands, inflammation, malaise, lung/resp. inflammation, irritation.
Age: 54.0
Sex: M
Vaccine: FLUX, MMR
Symptoms: Pain, Pneumonitis, Respiratory tract irritation
Clinical narrative: Auto immune reaction. Pain, stiffness, nodules on hands, inflammation, malaise, lung/resp. inflammation, irritation.