chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 35.0
Sex: M
Vaccine: FLU4
Symptoms: Hypoaesthesia
Clinical narrative: Patient complained of numbness of the arm, after administration of FLUARIX QUAD vaccine.
Age: 6.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Peripheral swelling, Pruritus
Clinical narrative: T/C with mother 8/14/15 stating that left arm red, 2" diameter, itching, swelling. Seen by ER Dr 8/16-antibiotics given.
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Varicella rash 6-7 days after vaccine w/VARIVAX. (observation).
Age: 26.0
Sex: M
Vaccine: MMR, TDAP
Symptoms: Erythema, Swelling
Clinical narrative: Redness at swelling quarter size noted. Informed client to take BENADRYL P.O., ice, BENADRYL cream. States did not do anything just left alone.
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Cellulitis, Erythema, Pain, Swelling
Clinical narrative: Patient experienced redness and swelling 2-3 hours after injection, and pain which continued to worsen through 8/12/15. She went to urgent care and was diagnosed with cellulitis. Filled a prescription for 7 days of BACTRIM DS dosed BID.
Age: 0.19
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC13, RV5
Symptoms: Blood culture positive, Culture urine positive, Differential white blood cell count, Full blood count, Pyrexia
Clinical narrative: Fever of 103.0 rectal in office mother states fevers were ranging from 100.0 this morning.
Age: 0.19
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC13, RV5
Symptoms: Urine analysis abnormal
Clinical narrative: Fever of 103.0 rectal in office mother states fevers were ranging from 100.0 this morning.
Age: 0.2
Sex: M
Vaccine: HIBV, PNC13, RV5
Symptoms: Agitation, Crying, Myoclonus
Clinical narrative: Crying and agitated for hours. Myoclonic jerking of head while awake and asleep-will be going to neurology for eval.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Dizziness, Headache
Clinical narrative: Pt. stated he felt dizzy and had a headache right after vaccine was administered. Pt. laid down, was given water and waited 20 min. in office.
Age: 1.01
Sex: M
Vaccine: MMR, PNC13, VARCEL
Symptoms: Erythema multiforme, Rash generalised
Clinical narrative: MMR, VARIVAX and PREVNAR given Thursday. Monday night without other signs of illness developed a rash. Tuesday morning I saw him an it covered his entire body and was clearly erythema multiforme.
Age: 0.51
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Blood culture, Culture urine, Electroencephalogram normal, Full blood count, Hypotonia
Clinical narrative: Afternoon or evening of 8/4/15 Pt was at store with parent. Had 5-7 min of vertical and horizontal nystagmus and limpness. No fever. Taken to nearby fire station and transport to ER. Normal EEG and MRI. No active findings on neuro exam. ER asked that we report.
Age: 0.51
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Metabolic function test, Nuclear magnetic resonance imaging normal, Nystagmus
Clinical narrative: Afternoon or evening of 8/4/15 Pt was at store with parent. Had 5-7 min of vertical and horizontal nystagmus and limpness. No fever. Taken to nearby fire station and transport to ER. Normal EEG and MRI. No active findings on neuro exam. ER asked that we report.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Erythematous skin patch on the (R) upper thigh with minimal induration, size of a baseball, without any distinctive rash elements, well demarcated; appeared 8-10 hr after injection of MMRV vaccine; enlarged in 24 hr, non-itching. No fever or constitutional sx. TYLENOL as needed for pain. Traced margins, f/u in 2 days or earlier as needed.
Age: 7.0
Sex: M
Vaccine: PPV
Symptoms: Flushing, Respiratory distress
Clinical narrative: As soon as injection was given, pt had flushing and respiratory distress. Albuterol per neb. 0.083% and epinephrine .20 given.
Age: 53.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pain, Pruritus, Skin warm, Swelling
Clinical narrative: Area is red, sore, swollen and itches. Hot to touch.
Age: 1.33
Sex: F
Vaccine: HEPA, HIBV, PNC13
Symptoms: Injection site erythema, Irritability, Pyrexia
Clinical narrative: Grandmother called baby developed 25 cent size red area on Rt thigh early evening after receiving PREVNAR 13 on Rt leg. Was fussy with low grade fever x 2 days. Symptoms improved.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: 3 days after HPV9 developed significant pain at injection site with radiation to palm. Pain so far lasted > 5 days, 7/10 in intensity with normal strength and sensation. No swelling or redness.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. The patient's medical history, drug reactions or allergies and concurrent conditions were not reported. On an unknown date, the patient were vaccinated with an improperly stored MMR II, lot number J013316, expiration date 22-JAN-2015 and lot number K004949, expiration date 04-APR-2016, (dose and route were not reported). There was no concomitant medication reported. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Age: 88.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Red swollen area around injection site - left arm 1 week after administration - Dr. prescribed antibiotic.
Age: 47.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Pruritus, Rash, Rash erythematous
Clinical narrative: Employee stated that at approximately 1900 on 17 Aug 15 she developed a rash to her chest area that was itching. It has since spread to her back on 8-18-15. It is a fine, raised red rash.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an  unspecified number of patients of unknown age and gender. No information on patients medical history or concurrent conditions was provided. On an unknown dates, the patients were vaccinated with an unspecified number of improperly stored doses of ROTATEQ oral solution, lot # K020182 with expiration date 25-JUN-2016 and lot # K007246 with expiration date 17-MAR-2016 (doses were not reported). No information on patients concomitant medication was provided. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: MNQ
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site induration, Injection site pruritus
Clinical narrative: Per client: "Immediately after getting meningitis shot [MENVEO] 2 in red circle at injection site. 1 day after injection redness, itching w/ hard center. 5 days after 4 x 2 circle no pain or itching.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an  unspecified patient of unknown age and gender. No information on patient's medical history or concurrent conditions were provided. On 06-JUL-2015, the patient was vaccinated with one improperly stored dose of ROTATEQ oral solutions, lot # K020182, expiration date 25-JUN-2016 (dose was not reported). No information on patient's concomitant medication was provided. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Burning sensation, Erythema, Injection site pain, Pain in extremity, Pruritus
Clinical narrative: At 4:00 am on 8-14-2015 pt was awaken with pain at site of injection, no redness, no swelling and bil-hands burning and itching. Pt seen in clinic at 9:00 a,. Bil hands still burn and itch- red pain side 6/10-Tx from BENADRYL and prednisone. Symptoms worse. Instructed to RTC if not resolving.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist regarding two unspecified infants of unknown age and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. On 15-JUN-2015, the patients were vaccinated with an improperly stored dose of RECOMBIVAX HB (dose and route of administration were not reported, lot number K010535 with expiration date 27-AUG-2016 or lot number K020216 with expiration date 17-SEP-2016). There were no adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist regarding two unspecified infants of unknown age and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. On 12-JUN-2015, the patients were vaccinated with an improperly stored dose of RECOMBIVAX HB (dose and route of administration were not reported, lot number K010535 with expiration date 27-AUG-2016 or lot number K020216 with expiration date 17-SEP-2016). There were no adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Computerised tomogram, Lymphadenopathy, Nuclear magnetic resonance imaging, Pain
Clinical narrative: This spontaneous report as received from a patient's friend refers to a 17 year old female patient. The patient's concurrent conditions and medical history were not reported. On 04-AUG-2015 (reported as 1 week ago), the patient was vaccinated with the first dose of GARDASIL (dose, route of administration, lot number and expiration date were not reported). Concomitant therapy was not reported. On 10-AUG-2015, the patient acquired a swollen lymph node behind the shoulder by the injection site that was causing pain. On an unknown date, the patient had computerized tomography scan and magnetic resonance imaging with no results reported. There was no treatment given to the patient for the events. The outcome of the events was reported as not recovered. The patient sought medical attention. The relatedness between the events and the GARDASIL was not reported. Additional information is not expected, as no contact details were provided.
Sex: M
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: This spontaneous report as received from a pharmacist refers to a male patient of unknown age. Medical history was not reported. On an unknown date when in an Intensive Care Unit (ICU) for an unspecified reason, the patient was vaccinated with PNEUMOVAX 23 (dose number, route and lot # were not reported) by an unspecified healthcare provider. On an unknown date the patient experienced a fever of 100.1 Fahrenheit within 12 hours of receiving the vaccine. The patient was started on an unspecified antibiotic. The outcome of the fever was unknown. The reporter did not provider the causality between the event and the suspect therapy. This is one of the several reports received from the same reporter. 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 healthcare worker refers to a 6 unspecified patients of unknown age and gender. The patient's medical history, drug reactions or allergies and concurrent conditions were not reported. On an unknown date, the patients were vaccinated with an improperly stored PROQUAD (Merck), lot number reported as L011080, expiration date 01-OCT-2016, (dose and route were not reported). There was no concomitant medication reported. No adverse effects were reported. This is one of several reprots 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 nurse refers to two unspecified patients of unknown demography. No concurrent condition, medical history or allergy/drug reactions were reported. On multiple unspecified dates, the two unspecified patients were each administered improperly stored (Oka/Merck) VARIVAX (lot # K016129, exp. date: 23-SEP-2016) (dose, strength, route and frequency were not reported). No adverse effects were reported. 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: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist regarding an unspecified infant of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 13-JUN-2015, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB (dose and route of administration were not reported, lot number K010535 with expiration date 27-AUG-2016 or lot number K020216 with expiration date 17-SEP-2016). There were no adverse effects reported. This is one of several reports received from the same reporter. 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 infant of unknown age and gender. The patients' concurrent conditions and medical history were not reported. On 22-JU-2015, the patient was vaccinated with a dose of improperly stored RECOMBIVAX HB (doses and routes of administration were not reported, lot number K010535, expiration date 27-AUG-2016 or lot number K020216 and expiration date 17-SEP-2016). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist regarding an unspecified patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 14-JUN-2015, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB (dose and route of administration were not reported, lot number K010535 with expiration date 27-AUG-2016 or lot number K020216 with expiration date 17-SEP-2016). There were no adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Pruritus
Clinical narrative: Rash, urticaria pruritus and redness, pain, heat, swelling at injection site. Methylprednisolone, doxycycline BID.
Age: 60.0
Sex: M
Vaccine: PPV
Symptoms: Rash, Urticaria
Clinical narrative: Rash, urticaria pruritus and redness, pain, heat, swelling at injection site. Methylprednisolone, doxycycline BID.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist regarding 4 unspecified infants of unknown age and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. On 16-JUN-2015, the patients were vaccinated with an improperly stored dose of RECOMBIVAX HB (dose and route of administration were not reported, lot number K010535 with expiration date 27-AUG-2016 or lot number K020216 with expiration date 17-SEP-2016). There were no adverse effects reported. This is one of several 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 has been received from a Registered Nurse referring to a patient of unknown age and gender. No concurrent or historical conditions was reported. On 31-JUL-2015 the patient was vaccinated with improperly stored dose of GARASIL, lot # K023432, expiration date: 18-JUN-2016, dose, route, frequency and anatomical location were unknown. No adverse symptoms reported. No product quality complaint was reported. This is one of several cases received from the same source (MARRS numbers: 1508USA003819, 1508USA005117, 1508USA005118, 1508USA005119, 1508USA005120, 1508USA005121, 1508USA005122, 1508USA005123, 1508USA00124). Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a Registered Nurse referring to a patient of unknown age and gender. No concurrent or historical condition was reported. On 03-AUG-2015, the patient was vaccinated with improperly stored dose of RECOMBIVAX HB lot # K010535, expiration date: 27-AUG-2016, dose, route, frequency and anatomical location were unknown. No adverse symptoms reported. No product quality complaint was reported. This is one of several cases received from the same source. (MARRS number 1508USA003819, 1508USA005117, 1508USA005118, 1508USA005119, 1508USA005120, 1508USA005121, 1508USA005122, 1508USA005124, 1508USA005125). 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 healthcare worker refers to an unspecified number of patients of unknown age and gender. No information on patients medical history or concurrent conditions was provided. On an unknown dates, the patients were vaccinated with an unspecified number of improperly stored doses of GARDASIL injection, lot # K005881 with expiration date 14-JAN-2017 and lot# K006960 with expiration date 19-FEB-2017 (doses and routes of administration were not reported). No information on patients concomitant medications was provided. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 36.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Exposure during pregnancy, Pruritus
Clinical narrative: Patient went to Emergency Room as advised by LPN after complaints of itching and redness. Emergency Room MD treated with PO 1 dose Prednisone 40 mg and 25mg IV BENADRYL for 1 dose.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to a patient of unknown age and gender. The patient's medical history, drug reactions or allergies and concurrent conditions were not reported. On 10-AUG-2015, the patient was vaccinated with an improperly stored LIQUID PEDVAXHIB, lot number L004740, expiration date 16-NOV-2017 (dose and route were not reported). There was no concomitant medication reported. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Age: 34.0
Sex: F
Vaccine: MMR
Symptoms: Cellulitis
Clinical narrative: Cellulitis developed > 1 week from injection. Patient given course of BACTRIM DS x 7 days.
Age: 17.0
Sex: F
Vaccine: HEP, HPV4, IPV, MMR, VARCEL
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Adult dose administered to 17 y/o (pt weights 164.5 lbs, 71/5 inches tall).
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist regarding an unspecified infant of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 11-JUN-2015, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB (dose and route of administratiton were not reported, lot number K010535 with expiration date 27-AUG-2016 or lot number K020216 with expiration date 17-SEP-2016). There were no adverse effects reported. This is on of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist regarding two unspecified infants of unknown age and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. On 19-JUN-2015, the patients were vaccinated with an improperly stored dose of RECOMBIVAX HB (dose and route of administration were not reported, lot number K010535 with expiration date 27-AUG-2016 or lot number K020216 with expiration date 17-SEP-2016). There were no adverse effects reported. This is on of several reports received from the same reporter. 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 a 3 unspecified infants of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 29-JUN-2015, the patient were vaccinated with a dose of improperly stored RECOMBIVAX HB (doses and routes of administration were not reported, lot number K010535 and expiration date 27-AUG-2016, lot number K020216 and expiration date 17-SEP-2016). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Unevaluable event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a male patient of unknown age. On approximately 03-AUG-2015 reported as 11 days ago) the patient was vaccinated with a dose of ZOSTAVAX (lot #, strength, dose and route were not reported). In approximately August 2015 (reported as now) the patient was starting a therapy on a short-term taper dose of prednisone for an unspecified reason (the onset date of adverse event was not reported). The outcome of the patient's events was not reported. The relatedness between vaccination with ZOSTAVAX and the patient's event was not 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 infant of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 28-JUN-2015, the patient was vaccinated with a dose of improperly stored RECOMBIVAX HB (doses and routes of administration were not reported, lot number K010535, expiration date 27-AUG-2016 or lot number K020216 and expiration date 17-SEP-2016). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist regarding an unspecified infant of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 20-JUN-2015, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB (dose and route of administration were not reported, lot number K0101535 with expiration date 27-AUG-2016 or lot number K020216 with expiration date 17-SEP-2016). There were no adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 1.6
Sex: U
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an 18 month old patient of unknown gender. No information regarding the patient's medical history or concurrent conditions was provided. On 17-AUG-2015, the 18 month old patient was vaccinated with a dose of GARDASIL injection (strength, dose, route of administration, lot # and expiry date were not reported). There were no concomitant therapies reported. No adverse experience was reported. There was no product quality complaint (PQC) involved. 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 2 unspecified infants of unknown age and gender. The patients' concurrent conditions and medical history were not reported. On 27-JUN-2015, the patients were vaccinated with a dose of improperly stored RECOMBIVAX HB (doses and routes of administration were not reported, lot number K010535, expiration date 27-AUG-2016, lot number K020216 and expiration date 17-SEP-2016). No adverse effects were reported. This is one of several reports received from the same source. 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 infant of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 26-JUN-2015, the patient was vaccinated with a dose of improperly stored RECOMBIVAX HB (doses and routes of administration were not reported, lot number K010535, expiration date 27-AUG-2016 or lot number K020216 and expiration date 17-SEP-2016). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist regarding an unspecified infant of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 17-JUN-2015, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB (dose and route of administration were not reported, lot number K010535 with expiration date 27-AUG-2016 or lot number K020216 with expiration date 17-SEP-2016). There were no adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, PNC13
Symptoms: Unevaluable event
Clinical narrative: Please see attached.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacist refers to 2 unspecified patients of unknown age and gender. On unknown dates, the patients were vaccinated with ZOSTAVAX (route, dose, lot # and expiration date were not provided). On  unknown dates, following the administration of ZOSTAVAX, the patients developed herpes zoster referred as shingles. At the time of the report, the outcome of herpes zoster was unknown. Additional information is not expected as no reporter details were provided.
Age: 66.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Injection site erythema
Clinical narrative: Large area of redness on upper arm where vaccine was given. Patient said the reaction started day after vaccine was received. Had chills that since have subsided.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions or allergies were not reported. On an unknown date, the patient was vaccinated with an improperly stored (Oka/Merck) VARIVAX, 0.5 ml once, subcutaneous, lot number L006386, expiration date 25-FEB-2017). There was no concomitant medication reported. No adverse events were reported after (Oka/Merck) VARIVAX was administered. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 04-JUN-2014, the patient was vaccinated with the first dose of GARDASIL, intramuscularly, (dose, injection site, lot number and expiration date were not reported). According to the reporting healthcare worker, on 17-AUG-2015, the patient was receiving the second dose of GARDASIL, intramuscularly, (dose, injection site, lot number and expiration date were not reported). No adverse effects were reported. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Pyrexia, Rash papular
Clinical narrative: Diffuse papulovesicular lesions in varying stages on visit 8/18/15. Patient had fever around 101 on 8/16/15 then rash started. Had 2nd Varicella on 8/6/15.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician via field employee refers to a female patient of unknown age. There were no concomitant therapies concurrent conditions or medical history provided. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (dose, route of administration, lot # and expiration date not reported). On an unknown date, the patient developed shingles. The reporter questioned the efficacy of the ZOSTAVAX. The outcome of shingles was reported as recovered. The outcome of the questioned lack of efficacy was unknown. The reporter did not assess the relatedness between the events and ZOSTAVAX. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 81.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pain
Clinical narrative: Soreness, redness started 4-6 days after vaccine was administered.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. No pertinent medical history or concurrent conditions were reported. On an unspecified date, in 2012, the patient was vaccinated with the first dose of RECOMBIVAX HB 10 MCRG/1.0 ML, (route of administration, lot # and expiration date were not provided). Approximately, in 2015 (reported as "3 years after the first dose"), the patient received the second dose of RECOMBIVAX HB, (dose, lot #, expiration date and route were not reported), (inappropriate schedule of drug administration). No adverse effects were reported. It was unknown if the patient sought medical attention. No product quality complain was involved. Additional information has been requested.
Sex: F
Vaccine: MMRV
Symptoms: Injection site rash
Clinical narrative: Nickel-sized raised patch in left arm adjacent and inferior to injection site after MMRV injection. Child observed in clinic for 10-15 minutes after reaction. No new rash, no change in rash and no respiratory problem noted.
Age: 21.0
Sex: F
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 21 year old female patient. No information regarding the patient's medical history or concurrent conditions was provided. On an unknown date, the 21 year old patient was vaccinated with a dose of PROQUAD (Merck) injection  (strength, dose, route of administration, lot # and expiry date were not reported). There were no concomitant therapies reported. No adverse effect was reported. There was no product quality complaint (PQC) involved. Additional information has been requested.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Blood creatine phosphokinase increased, C-reactive protein normal, Fatigue, Full blood count normal, Pain
Clinical narrative: Patient received a Tdap in right arm on 8/17/15 then on 8/18/15 she developed fatigue and body achiness. States her right arm is more achy than other areas of her body. Patient seen by doctor on 8/18/15.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in extremity
Clinical narrative: Patient received a Tdap in right arm on 8/17/15 then on 8/18/15 she developed fatigue and body achiness. States her right arm is more achy than other areas of her body. Patient seen by doctor on 8/18/15.
Sex: U
Vaccine: VARCEL
Symptoms: Polymerase chain reaction, Rash vesicular
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender. The patient was enrolled in the Varicella Zoster Virus Identification. Program to identify if VZV is present and if it is present, to identify if it is associated with the wild-type (WT) VZV strain or with the OKA/Merck vaccine strain. Patient's medical history, concurrent conditions and concomitant therapy were not reported. On an unknown date, the patient was vaccinated with a dose of (Oka/Merck) VARIVAX (lot number, dose and route were not reported). On an unknown date the patient experienced chickenpox type rash. The outcome of the event was not reported. The relatedness between the vent and (Oka/Merck) VARIVAS was not reported. Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Back pain, Headache, Nausea, Pain in extremity, Pyrexia
Clinical narrative: Nausea, fever, headache, arm pain, mid back pain.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to unspecified number of patients of unknown age and gender. There was no information about patients' concomitant medications, pertinent medical history, drug reactions and allergies. On unspecified dates, the patient's were vaccinated with improperly stored (Oka/Merck) VARIVAX (lot# K015992, expiration date 23-SEP-2016, dose, frequency, route and site of administration were not reported). No adverse events were reported. This is one of several reports received from the same reporter. 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 medical assistant refers to unspecified number of patients of unknown age and gender. There was no information about patients' concomitant medications, pertinent medical history, drug reactions and allergies. On unspecified dates, the patients were vaccinated with improperly stored PROQUAD (Merck) (lot # L002419, expiration date 23-JUL-2016, dose, frequency, route and site of administration were not reported). No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to a patient of unknown age and gender. Pertinent medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored dose of VAQTA (lot # K012457, expiry date 04-JUN-2017, dose and route of administration not reported). No adverse effects were reported. 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 healthcare worker refers to a 2 unspecified patients of unknown age and gender. The patient's medical history, drug reactions or allergies and concurrent conditions were not reported. On an unknown date, the patients were vaccinated with an improperly stored PROQUAD (Merck), lot number L007229, expiration date 03-SEP-2016, (dose and route were not reported). There was no concomitant medication 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 Medical Assistant refers to an unspecified number of patients of unknown ages and genders whom since 01-JUL-2015, had been administered doses of  ROTATEQ (lot # K023534, expiration date: 15-APR-2016)(doses and routes not reported) that were improperly stored. No adverse effects reported. Additional information has been requested (correspondence containing a request for additional information is scheduled).
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to an unspecified number of unspecified patients of unknown age. Concurrent conditions, medical history and concomitant medications were not reported. On an unspecified dates since 26-JUN-2015, the patients were vaccinated with an unspecified number of improperly stored doses of ZOSTAVAX (lot # K020186, expiry date 2 2-JAN-2016 (dose, frequency and route of administration not reported). No adverse effect reported. No product quality complaint (PQC) was involved. No additional information provided.  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 concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions or allergies were not reported. On an unknown date, the patient was vaccinated with an improperly stored (Oka/Merck) VARIVAX, 0.5 ml once, subcutaneous, lot number L006386, expiration date 25-FEB-2017. There was no concomitant medication reported. No adverse events were reported after (Oka/Merck) VARIVAX was administered. This is one of several reports from the same source. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Paraesthesia, Paraesthesia oral
Clinical narrative: This spontaneous report was received from a 60 year old female patient regarding herself. The patient's concurrent condition included fibromyalgia and unspecified sensitive's and/or slight reactions to medication in general. On 13-DEC-2014, the patient was vaccinated with ZOSTAVAX in her right arm, (dose, route, lot number and expiration date were not reported. The patient's concomitant therapies included Vit D3 (unspecified); Vitamin B (unspecified) and Fish Oil. On the same date 15 to 30 minutes after vaccination with ZOSTAVAX, the patient "felt sick and needed to sit down" (malaise), and she experienced paraesthesia and paraesthesia oral described as "felt tingling on feet and lips" for 10 to 15 minutes. At the time of the report, the outcome of the "felt sick and needed to sit down" and "felt tingling on feet and lips" was reported as recovered on 13-DEC-2014, in addition the patient stated that she was able to walk around to resolved the feeling of sickness and tingling. No treatment was given for the events above described. The patient did not seek medical attention. The relatedness between the events and therapy with ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a patient of unknown age and gender. The patient's pertinent medical history or concurrent conditions were not provided. On 19-JUN-2015, the patient was vaccinated with an unspecified dose of GARDASIL 9 (dose, route and lot # were unknown) and subsequently and on 05-AUG-2015, the patient was vaccinated with an unspecified dose of GARDASIL (dose, route and lot # were unknown). No adverse experiences and no product quality complaint were reported. 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 certified medical assistant refers to an unspecified number of patients of unknown age and gender. Concurrent conditions and medical history were not reported. On an unknown date, the patients were vaccinated with doses of (Oka/Merck) VARIVAX (lot # reported as L009205, expiration date 17-MAR-2017; lot # L007224, expiration date 03-MAR-2017) (route and dose were not provided) which had temperature excursion. Concomitant medication was not reported. No adverse effects reported. This is one of several reports from the same source. 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 certificated medical assistant refers to an unspecified number of patients of unknown age and gender. Concurrent conditions and medical history were not reported. On an unknown date, the patients were vaccinated with doses of GARDASIL 9 (lot # K026246, expiration date 28-JAN-2017) (Route and dose were not provided), which had temperature excursion. Concomitant medications were not reported. No adverse effects reported. This is one of several reports 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 as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. Concurrent conditions and medical history were not reported. On an unknown date, the patients were vaccinated with doses of PROQUAD (Lot # reported as L010143, expiration date 24-SEP-2016; Lot # L008356, expiration date 11-SEP-2016) (Route and dose were not provided), which had temperature excursion. Concomitant medication was not reported. No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
Age: 71.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient called clinic this AM, patient had received pneumo. vac. right del. C/O upper right arm swelling, red and tender since getting pneumo. vac. here at clinic day before yesterday (12-20-11). Patient was advised to come to clinic for evaluation of injection site. From outer aspect of right del. to near elbow, slight swelling and red/pink in color. Per ARNP patient needs to start BENADRYL OTC, every 4-6 hours prn. also 2cc dexamethasone. Given IM left glu.tolerated well without complaint. (lot # 6101807, exp: 10/12) Advised to call clinic if no improvement or symptoms worsen or ER of after hours. Advised not to drive when taking BENADRYL. Patient voiced understanding.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Nurse practitioner referring to an unspecified number of patients of unknown ages and genders. No concurrent or medical condition was reported. On an unknown date the patients received improperly stored doses of (Oka/Merck) VARIVAX lot # L007225, expiration date: 22-OCT-2016, dose, route, frequency and anatomical location were not reported. No concomitant medication was reported. No adverse event was reported. No further information was provided. No product quality complaint reported. This is one of several cases received from the same source (MARRS numbers 1508USA005092, 1508USA005093). 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 registered nurse and refers to an unspecified number of patients of unknown age and gender. Pertinent medical history or drug allergies/drug reactions were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of M-M-R II (lot # J013431, expiration date 24-OCT-2015)(dose, strength and route of administration were not reported). There was no concomitant medication reported. No adverse effects were reported. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: HEP, HEPA
Symptoms: Hepatitis A antibody negative, Hepatitis B antibody negative
Clinical narrative: This spontaneous report was received from a 70 year old consumer reporting on herself a patient. The patient's concurrent conditions included rheumatoid arthritis, immune system disorder reported as weakened immune system and drug reactions or allergy to CIMZIA. In 2013, reported as "about 2 years ago", the patient was vaccinated with doses of Hepatitis B Vaccine (manufacturer unknown), IM (anatomical location, lot # and expiration date were not reported) and doses of Hepatitis A Vaccine (manufacturer unknown) IM (anatomical location, lot # and expiration date were not reported). It was reported that the patient had a three dose series of doses of Hepatitis B Vaccine (manufacturer unknown) and Hepatitis A Vaccine (manufacturer unknown). It was unspecified if the patient received three doses of Hepatitis A Vaccine (manufacturer unknown) and three doses of Hepatitis B Vaccine (manufacturer unknown) separately, or the patient received three doses of an unspecified combination Hepatitis B Vaccine (manufacturer unknown) and Hepatitis A Vaccine (manufacturer unknown). Concomitant therapies included ENBREL. The patient stated that on an unspecified date in 2014, after receiving Hepatitis B Vaccine (manufacturer unknown) and Hepatitis A Vaccine (manufacturer unknown), she had blood work that resulted in no titers for either vaccine. Additionally, the patient stated that she was on ENBREL while receiving the three dose series and stated that it was not working. No treatment was given for the adverse events. The patient sought medical attention by visiting office. The outcome of hepatitis B surface antibody negative and hepatitis A antibody negative was reported as not recovered. The relatedness between the events and suspect therapies was not provided. Additional information is not expected, no contact details were provided.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. Concurrent conditions and medical history were not reported. On an unknown date, the patients were with vaccinated doses of ROTATEQ (lot # reported as L000568, expiration date 10-JUL-2016, lot # K020182, expiration date 25-JUN-2016) (oral, dose was not reported), which had a temperature excursion. Concomitant medications were not reported. No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
Age: 64.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Influenza like illness, Pyrexia
Clinical narrative: Fever and chill, influenza-like illness.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certificated medical assistant refers to an unspecified number of patients of unknown age and gender. Concurrent conditions and medical history were not reported. On an unknown date, the patients were vaccinated with doses of PEDVAXHIB (lot # K025002, expiration date 20-JUL-2017) (Route and dose were not provided), which had temperature excursion. Concomitant medications were not reported. No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certificated medical assistant refers to an unspecified number of patients of unknown age and gender. Concurrent conditions and medical history were not reported. On an unknown date, the patients were vaccinated with doses of VAQTA (lot # K005323, expiration date 10-FEB-2017) (Route and dose were not provided), which had temperature excursion. Concomitant medication were not reported. No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.