chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Bradycardia, Dizziness, Immediate post-injection reaction, Syncope
Clinical narrative: This spontaneous report was received from a physician via company representative refers to a male patient of unknown age. No concurrent condition or medical history was reported. On an unknown date the patient was vaccinated with GARDASIL (dose 1, intramuscular, dose not provided). The patient experienced bradycardia and he felt light headed and faint immediately following the vaccination. The patient recovered from the events while he was still at the Physician's office. On an unknown date the patient was vaccinated with second dose of GARDASIL (intramuscular, dose not provided) in accordance with the vaccine schedule. The events reappeared after second vaccination. The physician implemented conservative measures when the second dose was administered which included having the patient lie down. The patient again recovered from all the events while he was still at physician's office. The causality assessment was not reported. No product quality issue was reported. Additional information has been requested.
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Asthenia, Blood pressure decreased, Bradycardia, Dizziness, Heart rate decreased
Clinical narrative: This spontaneous report was received from a physician via company representative refers to a male patient of unknown age. No concurrent condition or medical history was reported. On an unknown date the patient was vaccinated with GARDASIL (dose 1, intramuscular, dose not provided). The patient experienced bradycardia and he felt light headed and faint immediately following the vaccination. The patient recovered from the events while he was still at the Physician's office. On an unknown date the patient was vaccinated with second dose of GARDASIL (intramuscular, dose not provided) in accordance with the vaccine schedule. The events reappeared after second vaccination. The physician implemented conservative measures when the second dose was administered which included having the patient lie down. The patient again recovered from all the events while he was still at physician's office. The causality assessment was not reported. No product quality issue was reported. Additional information has been requested.
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Hyperhidrosis, Immediate post-injection reaction, Similar reaction on previous exposure to drug, Somnolence, Syncope
Clinical narrative: This spontaneous report was received from a physician via company representative refers to a male patient of unknown age. No concurrent condition or medical history was reported. On an unknown date the patient was vaccinated with GARDASIL (dose 1, intramuscular, dose not provided). The patient experienced bradycardia and he felt light headed and faint immediately following the vaccination. The patient recovered from the events while he was still at the Physician's office. On an unknown date the patient was vaccinated with second dose of GARDASIL (intramuscular, dose not provided) in accordance with the vaccine schedule. The events reappeared after second vaccination. The physician implemented conservative measures when the second dose was administered which included having the patient lie down. The patient again recovered from all the events while he was still at physician's office. The causality assessment was not reported. No product quality issue was reported. Additional information has been requested.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus generalised
Clinical narrative: Whole body itchy sensation began 8/6/15 and has progressively worsened. Pt advised to begin 10 mg cetirizine QD by Rph tonight.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a health care professional refers to 8 unspecified patients of unknown demographics. On an unknown date the patient was vaccinated with PROQUAD (Merck) (Lot#L004006 and exp. 05-AUG-2016) (dose, route, dose # and frequency unspecified). Other suspect therapies included VARIVAX (Merck) (Lot# L012036 and exp. 07-APR-2017; Lot# K005183 and exp. 10-APR-2016) (dose, route, dose # and frequency unspecified). No concomitant medications were reported. The nurse reported that on an unknown date, 8 unspecified patients received a dose of VARIVAX (Merck) or PROQUAD (Merck) that at were improperly stored. No adverse effects reported. No further information was provided. Additional information has been requested.
Age: 15.0
Sex: M
Vaccine: HIBV, HPV4
Symptoms: Dizziness, Headache, Hyperhidrosis, Pyrexia, Vomiting
Clinical narrative: Lightheaded, dizzy, sweating then vomited and felt better. Symptoms occurred approximately 4 hours after vaccines administered-grandmother called approx 2 pm stating patient has a fever of 101.2 and a headache.
Age: 18.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative
Clinical narrative: This spontaneous report as received from a physician assistant refers to a 18 year old female patient with no drug reactions or allergies and with no medical history. No concomitant medications were reported. The physician assistant reported that the patient was administered 3 doses of RECOMBIVAX HB, (dose, route of administration, injection site, lot number and expiration date were not reported) on unspecified dates as a child. On an unknown date (reported as recently), the patient had been determined to have negative Hepatitis B antibody titers (lab diagnostic studies were performed on an unspecified date). The patient sought medical attention via visiting the physician's office. No treatment was given for the event. The outcome of the event of negative Hepatitis B antibody titers was unknown at the time of the report. The relatedness between the event and RECOMBIVAX HB was not reported. Additional information is not expected, because the reporter did not wish to be contacted.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Healthcare Worker regarding multiple unspecified patients of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date the patients were vaccinated with improperly stored LIQUID PEDVAXHIB lot # K025002, expiration date 20-JUL-2017. There was no information about concomitant medication. No adverse event was reported. No Product quality complaint (PQC) was involved. The outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Urticaria
Clinical narrative: Hives-treated with BENADRYL.
Age: 1.14
Sex: M
Vaccine: HEPA, HIBV, PNC13
Symptoms: Culture throat negative, Pyrexia, Rash, Streptococcus test negative
Clinical narrative: Pt awoke at 1200 8/6/15 with 102.7 degree fever, MOC administered TYLENOL, pt slept until 0800 8/6/15 when waking with 102.7 degree fever MOC administered IBN. Fever continued along with rash until 8/8/15.
Age: 27.0
Sex: F
Vaccine: HPV4
Symptoms: Cellulitis
Clinical narrative: Cellulitis, given antibiotic.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician regarding a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 16-JUN-2015, the patient received improperly stored VARIVAX (Merck) (lot#J012151, expiry date: 28-SEP-2015, dosing details were not specified) which was stored at 23 Fahrenheit for 27:00 hours. There was not concomitant medication reported. No adverse effects was reported and no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HEPA
Symptoms: Back pain, Injection site pain, Neck pain, Pain in extremity
Clinical narrative: Patient was given 2nd Hep A vaccine. Patient discharged from clinic however around 1230 mother called clinic reporting patient was having severe arm neck and back pain. Per dr, mother advised to return to clinic with patient. Imed on site within normal limits however patient continued to complain of severe pain. Patient was given ibuprofen 400 mg, lorazepam 0.5 mg po and observed in office for 3 hours then discharged home. Mother contacted next day on 8/8/15, stated still has pain however very minimal and doing much better.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Healthcare Worker regarding multiple unspecified patients of unkonwn demographics. There was no information about concurrent condition and historical medication. on an unknown date the patients were vaccinated with improperly stored GARDASIL 9 lot # L004741, expiration date- 04-MAR-2017. There was no information about concomitant medication. No Product quality complaint (PQC) was involved. The outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 48.0
Sex: F
Vaccine: PPV
Symptoms: Rash generalised
Clinical narrative: Rash all over the body the same evening of vaccination. Manged with diphenhydramine.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician regarding a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 22-JUN-2015, the patient received improperly stored VARIVAX (lot#J012151, expiry date: 28-SEP-2015, dosing details were not specified) which was stored at 23 Fahrenheit for 27:00 hours. There was not concomitant medication reported. No adverse effects was reported and no product quality complain involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 19.0
Sex: M
Vaccine: MNQ
Symptoms: Hyperhidrosis, Hypoaesthesia, Pallor, Syncope
Clinical narrative: Patient fainted about 5 minutes after the vaccination, he was pale, diaphoretic and stated he had numbness in both hands. He had not eaten and after the EMTs gave him a candy bar and water he was fine.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: Swollen, erythematous rash at injection site approximately 24 hours after admin. Treated with BENADRYL with no reduction in symptoms.
Sex: M
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician regarding a male patient of unknown age. Medical history and concurrent conditions were not reported. On 19-JUN-2015, the patient received improperly stored VARIVAX (lot#J012151, expiry date: 28-SEP-2015, dosing details were not specified) which was stored at 23 Fahrenheit for 27:00 hours. There was not concomitant medication reported. No adverse effects was reported and no product quality complain involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: MMRV
Symptoms: Varicella post vaccine
Clinical narrative: Patient had mild chicken pox bumps.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a nursing assistant referring to a currently 5 month old patient of unspecified gender. The patients' medical history, concurrent conditions, drug reactions and allergies were not reported. On an unknown date, the patient was vaccinated with ROTATEQ (dose unknown, lot# K009900, expiration date unspecified, route of administration defaulted to oral) that was stored improperly. This is one of 2 reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Healthcare Worker regarding multiple unspecified patients of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date the patients were vaccinated with improperly stored oral, ROTATEQ lot # K015816, expiration date- 29-MAY-2016, lot # K017576, expiration date- 12-JUN-2016. There was no information about concomitant medication. No adverse event was reported. No Product quality complaint (PQC) was involved. The outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician regarding a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 05-JUN-2015, the patient received improperly stored VARIVAX (lot#J012151, expiry date: 28-SEP-2015, dosing details were not specified) which was stored at 23 Fahrenheit for 27:00 hours. There was not concomitant medication reported. No adverse effects was reported and no product quality complain involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to unspecified number of patients of unknown age and gender. The patients' pertinent medical history and concurrent condition were not reported. The nurse reported that since 29-JUL-2015 the patients had been administered doses of VARIVAX (Merck) (lot# reported as L012036, expiration date 07-APR-2017; Lot#013064, expiration date 14-APR-2017; lot# L009206, expiration date 17-MAR-2017, dose, frequency and route were unknown) which were improperly stored. No adverse effects reported. There were no product quality complaints (PQC) involved. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician regarding a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 08-JUL-2015, the patient received improperly stored VARIVAX (Merck) (lot#J012151, expiry date: 28-SEP-2015, dosing details were not specified) which was stored at 23 Fahrenheit for 27:00 hours. There was not concomitant medication reported. No adverse effects was reported and no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from an agency from a nurse refers to a patient of unknown age (age reported as between 6 years and 12 years old) and gender. The patient was enrolled in a program. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 28-JUL-2015, the patient was vaccinated with the improperly stored dose of VARIVAX (lot # K026386, expiration date 15-DEC-2016; dose and route of administration were not reported). It was reported that the vials of VARIVAX underwent temperature excursions as follows: 07-JUL-2015 8.9 degrees of Celsius for 1 hour and 28 minutes, on 28-JUL-2015 0.4 degrees of Celsius for 1 hour and 25 minutes. The nurse reported that the patient had not experienced any adverse events. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician regarding a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 16-JUN-2015, the patient received improperly stored VARIVAX (Merck) (lot#K010440, expiry date: 22-JUL-2016, dosing details were not specified) which was stored at 23 Fahrenheit for 27:00 hours. There was not concomitant medication reported. No adverse effects was reported and no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician regarding a female patient of unknown age. Medical history and concurrent conditions were not reported. On 25-JUN-2015, the patient received improperly stored VARIVAX (Merck) (lot#J012151, expiry date: 28-SEP-2015, dosing details were not specified) which was stored at 23 Fahrenheit for 27:00 hours. There was not concomitant medication reported. No adverse effects was reported and no product quality complaint involved. This is one of several reprots received from the same reproter. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy
Clinical narrative: This spontaneous prospective pregnancy report as received from a medical assistant via company representative refers to herself, a 26 year old female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with the first dose of GARDASIL, (dose, route of administration, injection site, lot number and expiration date were not reported). On an unknown date, the patient became pregnant. The last menstrual period (LMP) and estimated date of delivery (EDD) was unknown at the time of the report. The pregnancy outcome was outcome pending. The fetus outcome was unknown. The patient sought medical attention of unknown type. No treatment was given for the adverse event. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: VARCEL
Symptoms: Varicella virus test negative
Clinical narrative: This spontaneous report as received from a patient's mother refers to a 25 year old healthy female who is allergic to amoxicillin and sulfur (reported as sulfer). The patient had no pertinent medical history. On an unknown date, (reported as she received as a child) the patient was vaccinated with a dose of VARIVAX (lot#, strength, dose and route were not reported). None of concomitant therapy was reported. On 29-JAN-2015, as the result of the patient's routine blood test, was found that her Varicella Zoster levels were equal or less than 135. The patient saw the physician, who suggested revaccination with VARIVAX because her immune system had not responded to the initial dose of VARIVAX. No treatment was given for adverse event. The outcome of the patient's event was not reported. The relatedness between vaccination with VARIVAX and the patient's event was not reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient's pertinent medical history was not provided. On 08-AUG-2015, the patient was vaccinated with an expired dose of ZOSTAVAX vial (dose, route of administration, lot # and expiration date were not provided). No adverse experience was reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown gender between the 6 years and 12 years old, who was involved in a patient support program. Information concerning medical history and concurrent condition was not reported. On 26-MAY-2015, the single dose vial of PROQUAD (Merck) underwent temperature excursions on 5.3 degrees Celsius for 2 hours and 8 minutes. On 30-JUN-2015 the patient was vaccinated with the improperly stored PROQUAD (Merck) (dose, strength and route were not reported, lot # K014798, expiry date: 12-MAR-2016). The patient had not experienced any adverse events. It was unknown if there was any relevant laboratory data. This case is one of several cases received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. There was no information about patient's concomitant medications and pertinent medical history reported. On 20-JAN-2015, the patient was vaccinated with first dose of GARDASIL (dose, route of administration, site, lot# and expiry date were not reported). On 23-MAR-2015, the patient received the second dose of GARDASIL (dose, route of administration, site, lot# and expiry date were not reported). The patient was in the office at the day of the report (on 23-JUL-2015), to receive the last third dose in the series. The patient would be getting for the third dose GARDASIL 9 (dose, route of administration, site, lot# an expiry date were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected as the reporter did not wish the further contact.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a health professional concerning 2 patients of unknown age and gender. Concurrent conditions and pertinent medical history were not reported. On 04-AUG-2015, the patients were vaccinated with improperly stored doses of GARDASIL (lot # K006960, exp. date 19-FEB-2017 and Lot # L004741, exp. date on 04-MAR-2017) (dose and route of administration were not reported). No adverse effects were reported. Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site discomfort, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: This spontaneous reprot has been received from a pharmacist referring to a 50 year old female patient, reporting on herself. The patient was allergic to morphine and had no pertinent medical history. On 28-JUL-2015 the patient was vaccinated with ZOSTAVAX lot # K018172 exp. date 02-DEC-2015, unknown dose, subcutaneous, on unspecified anatomical location. No concomitant medication was reported. The patient stated she began to experience discomfort at the injection site on 30-JUL-2015, which became worse in the evening of the same day. The pharmacist reported that the patient experienced an area at the site of injection of approximately 6 inches in diameter, red, warm and "tender to touch". The patient did not receive treatment and no lab diagnostic studies were performed. At the time of the report the outcome of redness, discomfort, warmth and tenderness in the injection site was reported as not recovered. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received via agency from a nurse refers to a patient of unknown age (age reported as between 13 years and 18 years old) and gender. The patient was enrolled in a program. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 28-JUL-2015, the patient was vaccinated with the improperly stored dose of VARIVAX (lot # K026386, expiration date 15-DEC-2016; dose and route of administration were not reported). It was reported that the vials of VARIVAX underwent temperature excursions as follows: on 07-JUL-2015 8.9 degrees of Celsius for 1 hour and 28 minutes and on 28-JUL-2015 0.4 degrees of Celsius for 1 hour and 25 minutes. The reporting nurse stated that the patient did not experience any adverse events. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HEP, LYME
Symptoms: Arthritis
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of chronic arthritis in a 26-year-old female patient who received ENGERIX B adult (batch number SKBENGB212A6, expiry date unknown). Co-suspect products included LYMERIX (batch number LYM194B9, expiry date unknown). Previously administered products included LYMERIX (1st dose received in 1999), LYMERIX (2nd dose received in 16th November 1999, batch number LY120F9), ENGERIX B adult (1st dose received on an unknown date, batch number ENG3001A4), ENGERIX B adult (2nd dose received on 16th November 1999, batch number SKBENG3074A), Influenza (received in October 1999, batch number U0067AA) and HAVRIX adult (2nd dose received in October 1999, batch number VHA584A4). On 3rd May 2000, the patient received the 3rd dose of ENGERIX B and the 3rd dose of LYMERIX. On an unknown date, an unknown time after receiving ENGERIX B adult and LYMERIX, the patient experienced chronic arthritis. On an unknown date, the outcome of the chronic arthritis was unchanged. It was unknown if the reporter considered the chronic arthritis to be related to ENGERIX B and LYMERIX.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Immediate post-injection reaction, Injection site urticaria
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of injection site urticaria in a 4-year old female patient who received INFANRIX (batch number J7X72, expiry date 4th November 2016). Concomitant products included IPOL. On 15th July 2015, the patient received INFANRIX (intramuscular) .5 ml. On 15th July 2015, immediately after receiving INFANRIX, the patient experienced injection site urticaria. The patient was treated with epinephrine and DECADRON. On an unknown date, the outcome of the injection site urticaria was unknown. It was unknown if the reporter considered the injection site urticaria to be related to INFANRIX. Additional details were provided as follows: The INFANRIX was given on the left thigh, and IPOL was given on the right thigh. On 15th July 2015, immediately after receiving INFANRIX, the patient experienced injection site urticaria at the left thigh. The patient was treated with epinephrine and DECADRON at the physician's office. The patient's parents were told to monitor the situation to call back if there were any complications.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse via Drug and Medical Device Contact Center Services referring to a patient of unknown gender between 6 years and 12 years old, who was involved in a patient support program. Information concerning medical history and concurrent condition was not reported. On 07-JUL-2015, the vial of VARIVAX (Merck) underwent temperature excursions on 8.9 degrees Celsius for 1 hour and 28 minutes. On 04-AUG-2015, the patient was vaccinated with the improperly stored VARIVAX (Merck) (dose, strength and route were not reported, lot # K026386, expiry date: 15-DEC-2016). There was no concomitant therapy reported. The patient had not experienced any adverse events. It was unknown if there was any relevant laboratory data. This case is one of several cases received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to two patients of unspecified age and gender. Concurrent conditions and medical history were not reported. on 28-JUL-2015, the patients were vaccinated with a improperly stored dose of (Oka/Merck) VARIVAX (Lot# L011082, expiration date 01-APR-2017) (Strength, dose, route were not provided). No concomitant medication was reported. No adverse effects were reported. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Antibody test negative
Clinical narrative: Information has been received from medical records received on 10-AUG-2015 regarding an experience reported in a case in litigation (MARRS # 1403USA000676.) A female patient of unknown age was vaccinated with PNEUMOVAX23 (date not reported.) The patient reported that "PNEUMOVAX does not take on any gamma globulin." No further information was reported. All available medical records will be provided upon request. Additional information is not expected.
Age: 54.0
Sex: M
Vaccine: PPV
Symptoms: Fatigue, Injection site erythema, Injection site warmth, Peripheral swelling
Clinical narrative: Pt presents to the clinic with swelling of the (L) arm and redness and warmth around injection site of PNEUMOVAX that he received yesterday. Pt reports achiness of the (L) arm and fatigue. Pt denies any difficulty breathing or feeling of throat swelling. Pt is given DEPO-MEDROL 80mg IM today and advised to take BENADRYL 50mg Q 4 hours throughout the day today. Pt is advised to contact clinic if no improvement tomorrow a.m.
Age: 1.0
Sex: M
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a Certified Medical Assistant (C.M.A.) concerning a 1 year old male patient. No concurrent conditions or medical history were reported. On 03-AUG-2015, the patient was inadvertently vaccinated with a dose of ZOSTAVAX (Lot # L003218 date: 30-APR-2016), 0.65 ml in the "right thigh" instead of receiving PROQUAD (Merck). No adverse effects reported at this time. Additional information is not expected as the reporter did not wish further contact.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker referring to an unspecified patient of unknown age and gender. No concurrent or historical condition was reported. On an unknown date the patient was vaccinated with ZOSTAVAX, lot number, dose, route, frequency and anatomical location were not reported. The reporter stated that the dose of ZOSTAVAX administered, may have bee exposed to temperature above the recommended storage temperature. No adverse experience has been reported. No additional information was provided. No concomitant medication was reported. Additional information has been requested.
Age: 2.0
Sex: U
Vaccine: PNC, PPV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 2 year old patient with cochlea implant. On 12-APR-2006, the patient was vaccinated with the first dose of PREVNAR 7 (dose, route and strength were not reported). On 30-MAY-2006, the patient was vaccinated with the second dose of PREVNAR 7 (dose, route and strength were not reported). On 25-JUL-2006, the patient was vaccinated with the third dose of PREVNAR 7 (dose, route and strength were not reported). On that day, the patient was also vaccinated with the first dose of PNEUMOVAX 23 (lot number, expiration dated, dose and route of administration were not reported. On 18-SEP-2007, the patient was vaccinated with the fourth dose of PREVNAR 7 (dose, route and strength were not reported). On that day, the patient was also vaccinated with the second dose of PNEUMOVAX 23 (lot number, expiration date, dose and route of administration were not reported). On 29-JAN-2009, the patient was vaccinated with the third dose of PNEUMOVAX 23 (lot number, expiration date, dose and route of administration were not reported). On 25-JUL-2011, the patient was vaccinated with the first dose of PREVNAR 13 (dose, route and strength were not reported). There was no concomitant medication reported. The registered nurse stated that the patient had not experienced any adverse effects. Additional information has been requested.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Therapeutic response unexpected
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 58 year old female patient with multiple cases of shingles per year. On an unknown date, when the patient was 57 years old, she was vaccinated with a dose of ZOSTAVAX (Lot number, expiration date, dose and route were not provided). Concomitant medications were not reported. The pharmacist reported that since the patient received ZOSTAVAX, she still had shingles outbreaks (three since receiving ZOSTAVAX). The amount of outbreaks per year had decreased and the outbreaks were much milder. The outcome of shingles outbreaks was unknown at the time of the report. The reporter did not assess the relatedness of ZOSTAVAX shingles outbreaks. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from the health professional referring to an unspecified number of patients of unknown demographics. Relevant medical history, concurrent conditions and drug reactions/allergies of these patients were not reported. On unknown dates, these patients were vaccinated with improperly stored ROTATEQ (lot # K001948, expiry date: 07-JUN-2017; lot # K020181, expiry date: 24-JUN-2016; lot # K014826, expiry date: 28-MAY-2016). Concomitant medications were not reported. No adverse effects were reported. This is one of the three reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse (LPN) concerning unspecified number of patients of unknown age and gender. No concurrent conditions or medical history were reported. On an unknown date, the patients were vaccinated with unspecified doses of improperly stored M-M-R II (Lot # K004949 Expiration date: 04-APR-2016) (doses, routes and anatomical location of administration were not reported). No adverse effect was reported. This is one of two reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from the health professional referring to an unspecified number of patients of unknown demographics. Relevant medical history, concurrent conditions and drug reactions/allergies of these patients were not reported. On unknown dates, these patients were vaccinated with improperly stored (Oka/Merck) VARIVAX (lot # K021936, expiry date: 10-NOV-2016; lot # L001327, expiry date: 13-JAN-2017; lot # L010144, expiry date: 24-MAR-2017). Concomitant medications were not reported. No adverse effects were reported. This is one of the three reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse (LPN) concerning unspecified number of patients of unknown age and gender. No concurrent conditions or medical history were reported. On an unknown date, the patients were vaccinated with unspecified doses of improperly stored GARDASIL (Lot # J013324 Expiration date: 12-FEB-2016, Lot # K010574 Expiration date: 08-APR-2017 and Lot # K006960 Expiration date: 19-FEB-2017) (doses, routes and anatomical location of administration were not reported). No adverse effect was reported. This is one of two reports received from the same source. 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 medical assistant referring to an unspecified number of patients of unknown age and gender. No medical history or concurrent conditions were provided. On an unspecified date, the patients were vaccinated with an improperly stored dose of (Oka/Merck) VARIVAX, (dose, route of administration were not reported), (Lot # K018959, expiration date 15-OCT-2016). At the time of this report, no adverse effects were reported. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: This spontaneous report was received from a pharmacist referring a 69 year old female patient. Concurrent condition and medical history were not reported. On 17-JUL-2015, the patient was vaccinated with ZOSTAVAX lot # L003218 and expiration date on 30-APR-2015 in the arm (unspecified location) (strength, dose#, dose and route of administration were not reported). It was also reported that the patient was concomitantly vaccinated with PREVNAR 13 on the opposite arm on the same day as when she received the ZOSTAVAX. Others concomitant therapies included generic alendronate sodium and levothyroxine sodium (manufacturer unknown). On 17-JUL-2015, afterwards ZOSTAVAX vaccination the patient experienced a localized red rash at the injection site. The patient sought for medical attention but, no treatment was given or laboratory diagnostics studies were performed. At the time of the report, the outcome of the event was unknown. The relatedness of the adverse event and suspect therapy was not provided. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site swelling, Vomiting
Clinical narrative: This spontaneous report as received from a nurse via company representative refers to a 11 year old female patient. No demographic information was provided for the nurse. The patient's had received three doses of GARDASIL on an unspecified dates. No concurrent conditions were reported. On an unknown date, the patient was vaccinated with GARDASIL 9 injection (lot number, dose, frequency and route of administration not reported). No concomitant medications were reported. In 2015 (dates unspecified), the patient experienced vomiting about four times. On 29-JUL-2015, the patient experienced rash, pain, redness and swelling at the GARDASIL 9 injection site. The outcome of rash, vomiting, pain, redness and swelling was unknown. No further details were provided. No product quality complaint (PQC) was filed. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to multiple unspecified patients of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date the patients were vaccinated with improperly stored GARDASIL lot # K007264, Exp: 02-MAR-2017; Lot: K010574 Exp: 08-APR-2017, Lot: L007531 Exp: 04-NOV-2016 (dose and route were not reported). No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a patient of unknown age and gender. On 03-AUG-2015, the patient was vaccinated with one of the improperly stored VARIVAX (Merck) lots L002215-exp. date 21-JAN-2017; L001332-exp. date 13-JAN-2017, L005300-exp. date 17-FEB-2017 (dose and route of administration not provided). No adverse effects or PQC were reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to multiple unspecified patients of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date the patients were vaccinated with improperly stored MMR II Lot: K009957 Exp: 14-JUL-2016, Lot: K004948 Exp: 04-APR-2016, Lot: K016153 Exp: 24-SEP-2016 (dose and route were not reported). No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to multiple unspecified patients of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date the patients were vaccinated with improperly stored ROTATEQ oral, Lot # K016314 Exp: 05-JUN-2016 and Lot # L000571 Exp: 26-JUL-2016 (dose was not reported). No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Age: 45.0
Sex: M
Vaccine: HEP
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of pain in thumb in a 45-year-old male patient who received ENGERIX B adult (batch number 995J5, expiry date 6th February 2017). Concomitant products included ENGERIX B adult. On 10th February 2015, the patient received the 2nd dose of ENGERIX B adult (intramuscular) 1 ml. On 30th March 2015, 48 days after receiving ENGERIX B adult, the patient experienced pain in thumb. On an unknown date, the outcome of the pain in thumb was not recovered/not resolved. The reporter considered the pain in thumb to be unlikely related to ENGERIX B adult. Additional details provided are as follows: On 15th January 2015, the patient received 1st dose of ENGERIX B adult. On 10th February 2015, at 09:31, the patient received his 2nd dose of ENGERIX B adult. About 7 weeks after receiving the 2nd dose of ENGERIX B adult, the patient notified the physician that he experienced pain in his right thumb. On the following week (6th April 2015), the patient visited the physician's office. The physician did find the pain but there was no swelling in the joint. The physician asked the patient to undergo some tests which included X-rays, immunology tests, and rheumatoid panel, but the patient was not compliant and none of these tests were performed. On the day of reporting (15th July 2015), the patient again visited the physician and was still complaining of the same pain in his right thumb and mentioned a little pain in the left thumb as well. On the same day, the patient received his 3rd dose of ENGERIX B adult. The nurse thought that thumb pain to be unlikely related to vaccination with ENGERIX B adult because of the timing and because the patient works all day with a computer keyboard or mouse.
Sex: U
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified adult patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 30-JUL-2015, the adult patient was vaccinated with a pediatric dose of VAQTA 25/0.5 (units not reported) (dose, route and lot number or batch number unspecified). No concomitant medications were reported. No adverse experience had been reported. The outcome of the event was unknown. There were no product quality complaints (PQC) involved. No additional information was provided. Additional information has been requested.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: This spontaneous report was received from a 56 year old female patient regarding herself. Concurrent condition and medical history were not reported. On 07-JUL-2015, the patient was vaccinated with ZOSTAVAX (lot # and expiration date were not provided) subcutaneous, dose was unknown. Concomitant medication included unspecified medications for unspecified reasons. On 10-JUL-2015, the patient started noticing a red dot around the injection site, she thought it was a bug bite, but then she started noticing new red dots after a few days, until she had five or six red dots around the injection site. She called her provider, who stated to use NEOSPORIN on the site (also reported as the patient did not received any treatment). At the time of the report, the patient was still seeing red dots appearing. The reporter would refer back to the provider for an appointment. There were no lab diagnostics studies reported. The reporter did not provide if the red dots around the injection site were related to ZOSTAVAX. Additional information is not expected since no contact details were provided.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a patient of unknown age and gender. No concurrent condition or medical history was reported. The reporter noted, that one unspecified patient was administered with improperly stored ZOSTAVAX (dose, route of administration and indication were unknown; Lot # K008885, an expiration date 20-SEP-2015) on 06-MAY-2015. There was no adverse effect reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health professional (medical assistant) refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 05-AUG-2015, the patient was inadvertently administered an improperly stored dose of MMR II injection, lot # J014876, exp. date: 21-NOV-2015 (strength, dose and route unspecified). No concomitant medications were reported. No adverse effects were reported. The outcome of the event was unknown. There were no product quality complaints (PQC) involved. No additional information was provided. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions and concomitant medications was provided. The registered nurse reported that on 04-AUG-2015 and 05-AUG-2015, the patients were vaccinated with improperly stored doses of MMR II, lot number K004949, expiration date 04-APR-2016 (dose, injection site and route of administration were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: This spontaneous report as received from a licensed practical nurse via a company representative refers to an unspecified number of patients of unknown age and gender. No information regarding pertinent medical history and concomitant medications was reported. On an unspecified dates in 2015 (reported as "in the past month"), a couple of patients was vaccinated with GARDASIL 9 0.5 ml (also reported as "unspecified dose"), intramuscular (lot numbers and expiration dates were not provided). On an unspecified dates in 2015 (reported as "in the past month"), after receiving GARDASIL 9, these patients fainted. No treatment was given for the event. The patients did not seek medical attention. The outcome of the event was reported as recovered/resolved on an unspecified date in 2015. The relatedness between the event and the vaccination with GARDASIL 9 was not provided. Additional information is not expected as the reporter did not wish to be contacted.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to unspecified patient of unknown age and gender. No concurrent condition, concomitant therapies or medical history were reported. The reporter noted, that one unspecified patient was administered with improperly stored ZOSTAVAX (dose, route of administration and indication were unknown; Lot # K008885, an expiration date 20-SEP-2015) on 27-APR-2015. There was no adverse effect reported. This is one of the several reports received from the same reporter. Additional information has been requested.