chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Anger, Autism spectrum disorder, Defiant behaviour, Disturbance in attention, Psychomotor hyperactivity
Clinical narrative: Hyperactivity, Defiant, Angry, Trouble focusing. Was diagnosed with Aspergers one week after MMR Vaccination.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Seizure
Clinical narrative: Information has been received from the neighbor of an estimated 13 year old female patient, who was enrolled in a market research. On an unknown date the patient was vaccinated with GARDASIL (lot#, dosage and route unspecified). The reporter heard 3rd hand that the patient had seizure the day after getting GARDASIL in 2016. The patient was hospitalized the neighbor of an estimated 13 year old released on an unspecified date in 2016. The reporter believed there were no lasting effects. The reporter considered seizure to be related to GARDASIL. Upon internal review, seizure was considered to be medically significant. Additional information is not expected as the reporter did not want to be contacted.
Age: 17.0
Sex: M
Vaccine: HEPA, HPV9, MENB, MNQ
Symptoms: Chest discomfort, Syncope
Clinical narrative: Syncope episode after admin of men b and hep a. Assisted pt to lying position and applied ice to back of neck. Pt verbalized he was feeling better, gave mcv4 & hpv. C/o of chest tightness, bp 140/90 hr 94. Remained lying for 10 min, assisted to seated position and observed for addition 10 mins. Pt stated he was feeling better.
Age: 21.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site oedema, Injection site swelling, Injection site urticaria, Injection site warmth
Clinical narrative: Middle of right upper arm where I gave her injection (subcutaneous) felt warm and swollen. It continued to get more red and became firm like a welt, warm to touch and edematous. Approx size- 45mmX45mm.
Age: 32.0
Sex: M
Vaccine: ANTH
Symptoms: Biopsy prostate abnormal, Lymphadenectomy, Prostate cancer, Prostatic specific antigen increased, Radical prostatectomy
Clinical narrative: Steadily increasing Prostate-specific antigen (PSA) level...02/15/2011 doctor noticed an exponential increase in PSA level and requested a prostate biopsy which confirmed aggressive prostate cancer...radical retropubic prostatectomy, bilateralpelvic lymphadenectomy treatment conduct 06/19/2012 at medical center.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to an unspecified number of patients of unknown age and gender. Patient's pertinent medical history and drug reactions o allergies were not reported. On unknown dates, the patients were vaccinated with improperly stored Gardasil 9 (lot # L024993 and expiration date 17-OCT-2017, dose and route of administration were not reported). Concomitant therapy was not reported. No adverse effects were reported. No product quality complaint (PCQ) was involved. This is one of the two reports received from the same reporter. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a consumer concerning her/his daughter, a 14 year old female patient who was enrolled in a market research. Since an unknown date in 2015, the patient completed 3 dose series of GARDASIL (dose, route, and lot# were unknown) within 12 months on unknown dates, rather than the 6 month indication (onset date reported as "sometime in 2016"). The reporter also stated that the patient received multiple vaccines on that day (unspecified date). The reported considered the event to be related to GARDASIL. Additional information is not expected since the reporter did not wish to be contacted.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to unspecified patients of unknown age and gender. There was no information about concurrent condition, medical history or concomitant medication. The unspecified patients received improperly stored various unspecified doses of VARIVAX, (lot # L032395, expiration date 09-MAY-2018; lot # M000761, expiration date 06-JAN-2018), (dose, frequency and route not reported) on 16-JUN-2016 and 17-JUN-2016. The vaccines were exposed to temperature 70 F for 45 minutes due to power outage. There was no previous temperature excursion. No adverse reactions were reported. This is one of 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 was received from a medical assistant and refers to a patient of and unknown age and gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On an unknown date, the patient was vaccinated with a dose of improperly stored M-M-R II lot # L038612 with expiration date: 07-OCT-2017, lot# L035674 with expiration date 17-SEP-2017 or lot# L023386 with expiration date: 25-JUN-2017 (dose and route of administration were not reported). Administered dose of M-M-R II underwent temperature excursion at 30.128 Fahrenheit degrees, for 2 hours. Previous excursion was at 14.6 Fahrenheit degrees, for 3. 72 minutes. Data logger was involved. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On 22-FEB-2016, the patient was vaccinated with the first dose of GARDASIL 9, injection, (dose, route of administration, injection site, lot number and expiration date were not reported). On 25-APR-2016, the patient received the second dose of GARDASIL 9, injection, (dose, route of administration, injection site, lot number and expiration date were not reported). The pharmacist stated that the third dose of GARDASIL 9, lot # M003659, expiration date: 20-SEP-2017, (dose, route of administration and injection site were not provided) was administered on 23-JUN-2016. No adverse reactions were reported. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Exposure to vaccinated person, Herpes zoster, Secondary transmission
Clinical narrative: This spontaneous report has been received from a physician via a company representative referring to a male patient of unknown age. Information about concurrent condition, concomitant medication and medical history was not provided. On an unknown date, an anonymous female was vaccinated with ZOSTAVAX 19400 plague forming unit(PFU), 19400 PFU single injection(lot number, expired date were not provided) subcutaneously. Two weeks later(date unspecified), the female patient's male spouse contracted shingles. The patient contact doctor's office for medical attention. The outcome of the shingles was not recovered. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report has been received from a registered nurse referring to a patient of unknown age and unknown gender. Information about concurrent condition, concomitant medication and medical history was not provided. On 01-JUN-2015, the patient was vaccinated a dose of PNEUMOVAX 23 (Lot #L003188, expired date 06-JUL-2016, dose and route were not provided). On 15-JUN-2016, the patient was vaccinated another dose of PNEUMOVAX 23 (lot #L040178, expired date 18-AUG-2017, dose and route were not provided). There was outside the recommendations per the PNEUMOVAX 23 prescribed information. No adverse effects were reported. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Pt. developed significant rash x 7 days which went away. Pt. then developed approx. 15-20 red patches approx. 2-5 cm. on left thigh over several days. Pt went to MD and diagnosed with shingles and given script for acyclovir. I called drug mfg. and went over studies with them. At this point we can't conclusively link this diagnosis to the vaccine. To do cultures the pustules would have to be more significant/oozing, etc.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Rash, Rash erythematous, Rash pustular
Clinical narrative: Pt. developed significant rash x 7 days which went away. Pt. then developed approx. 15-20 red patches approx. 2-5 cm. on left thigh over several days. Pt went to MD and diagnosed with shingles and given script for acyclovir. I called drug mfg. and went over studies with them. At this point we can't conclusively link this diagnosis to the vaccine. To do cultures the pustules would have to be more significant/oozing, etc.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 21-JUN-2016, the patient was vaccinated with an expired dose of VARIVAX lot # K008820, expiration date: 19-JUN-2016 (dose, route of administration and anatomical location were not reported). Concomitant therapies were not reported. No adverse effects 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 healthcare worker refers to multiple unspecified patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX lot # M005973, expiry date 02-FEB-2018 (dose, route and site of administration were not reported), in vaccination series. No adverse effects were reported. Administered doses of vaccines experienced the temperature excursion of 25.1 degrees Fahrenheit for 1 hour 50 minutes cumulatively. Data logger was involved. There was previous temperature excursion which was included in cumulative total. This is one of two reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker and refers to multiple unspecified patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD lot # M001152, expiry date 05-JUL-2017 (dose, route and site of administration were not reported). No adverse effects were reported. Administered doses of vaccines experienced the temperature excursion of 25.1 degrees Fahrenheit for 1 hour 50 minutes cumulatively. Data logger was involved. There was previous temperature excursion which was included in cumulative total. This is one of two reports received from the same source. Additional information has been requested.
Age: 15.6
Sex: M
Vaccine: HPV9
Symptoms: Immediate post-injection reaction, Throat irritation
Clinical narrative: Information has been received via a company representative, from an office manager (certified medical assistant) who was reporting on behalf of a physician, referring to a 15 year six months old male patient. There was no pertinent medical history or any drug allergies. On 02-JUN-2016 the patient received the third dose of GARDASIL 9 (lot# M005714, intramuscular). The patient's two previous dosed were of GARDASIL (vaccination dates, lot number and route unknown). There was no concomitant therapy. The patient immediately after the administration of the GARDASIL 9 stated the his throat felt "Funny", no other description was provided. The representative confirmed it was not an anaphylactic reaction. The patient was monitored for 10 minutes in the provider's office and the reaction resolved on an unknown date in June 2016. No lab diagnostics study was preformed. The patient recovered. The causality was not provided. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. In approximately 2014 (reported as "1-2 years ago"), the patient was vaccinated with ZOSTAVAX injection (exact dose, lot #, expiration date and route of administration were not reported). In approximately 2014, 1 week after administration of ZOSTAVAX, the patient developed a rash at the injection site. The patient sought unspecified medical attention. The outcome of injection site rash was reported as recovered/resolved, on an unknown date. Causality assessment was not provided. Additional information is not expected, as the reporter refused additional contact.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to multiple unspecified patients of unknown ages and genders. On unknown dates, the patients were vaccinated with improperly stored PEDVAXHIB (lot # reported as M001814, expiry date: 15-OCT-2018; lot # L051122, expiry date: 12-OCT-2018) via intramuscular route. No adverse effect reported. The outcome of the events was unknown. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 01-JUL-2016, the patient was vaccinated with an improperly stored dose of ZOSTAVAX lot # L046896, expiration date: 23-FEB-2017 (exact dose, route of administration and anatomical location were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 60 degrees Fahrenheit for 6 hours. There were no previous excursions reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to multiple unspecified patients of unknown ages and genders. On unknown dates, the patients were vaccinated with improperly stored GARDASIL 9 (lot # L048237, expiry date: 08-MAY-2017; lot # L024993, expiry date: 17-OCT-2017; lot # reported as L037554, expiry date: 25-DEC-2017). No adverse effect reported. The outcome of the events was unknown. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to multiple unspecified patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant the therapies were not reported. The pharmacist reported that the patients received a dose of ZOSTAVAX (lot # L040445, expiration date 15-JAN-2017, start date, dose and route unknown) which was improperly stored. No adverse effects reported. Additional information is not expected since the reporter does not wish to be contacted.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a office manager refers to patients of unspecified demographics. Reporter stated that doses of improperly stored ROTATEQ (units unspecified) (lot number, expiry date unspecified) were administered to unspecified patients on unspecified dates. No adverse events were reported. The outcome was unknown. No product quality complaint was 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 was received from a medical assistant and refers to two patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions and concomitant medications was provided.  On unknown dates, the patients were vaccinated with a dose of improperly stored VARIVAX lot #L045956 with expiration date: 27-NOV-2017, lot# reported as M000996 with expiration date: 07-JAN-2018 or lot# reported as M003440 with expiration date: 20-JAN-2018 (dose and route of administration were not reported). Administered doses of VARIVAX underwent temperature excursion at 30.128 Fahrenheit degrees, for 2 hours. Previous excursion was at 14.6 Fahrenheit degrees, for 3.72 minutes. Data logger was involved. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several 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 as received from a registered nurse refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapy were not reported. On 20-JUN-2016, the patient was vaccinated with one dose of VARIVAX (lot # L048465 and expiration date 02-DEC-2017, route of administration was not reported) that was improperly stored. No adverse effects were reported. No product quality complaint (PQC) was involved. It was stated that there was previous temperature excursion (date unspecified) with minus 7.7 Celsius degrees for 18 hours and 16 minutes. On 20-JUN-2016, the temperature of excursion was minus 7.0 Celsius degrees and the time frame of excursion was 16 hours and 44 minutes. On 21-JUN-2016, the temperature excursion was minus 10.4 Celsius degrees and the time frame of excursion was 3 hours and 6 minutes. The cumulative time out of range, including present excursion was 35 hours in the refrigerated range and 3 hours 6 minutes in unlimited range. It was stated that the conditions were back in range. 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 office manager refers to patients of unspecified demographics. Reporter stated that doses of improperly stored RECOMBIVAX HB 2.5/0.5 (unites unspecified) (lot number, expiry date unspecified) were administered to unspecified patients on unspecified dates. No adverse events were reported. The outcome was unknown. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 31.0
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy, No adverse event, Wrong drug administered
Clinical narrative: This spontaneous prospective pregnancy report was received from a registered nurse, referring to a 31 year old pregnant female patient. Neither pertinent medical history nor concomitant medications were reported and patient presented no known drug allergies. On 07-JUN-2016, the patient who was 30 weeks and 4 days pregnant, came to the office to be administered with t-dap vaccine, and was inadvertently given GARDASIL lot # K006191 with expiry date on 02-FEB-2017, intramuscular. The primary reporter states it was the patient's first baby and pregnancy. No adverse effects were reported. The patient became pregnant with last menstrual period (LMP) of 09-NOV-2015 and estimated delivery date (EDD) of 15-AUG-2016. Initial exposure to GARDASIL was at 30 weeks. The patient did not seek medical attention, no lab diagnostics studies were performed and no treatment was received. No product quality complaint was reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse practitioner referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 24-MAY-2016 the patient was vaccinated with M-M-R II (dose and route not reported, lot # K021950, expiration date 10-NOV-2016, therapy type rHA (recombinant human albumin)). Concomitant therapy was not reported. The vaccine was exposed to temperature excursion of 27.9 degrees Fahrenheit (F) for 20 hours 53 minutes and 41.7 F for 12 minutes. Data logger was involved. It was reported that there was no previous temperature excursion. No adverse effects were reported. This is one of two reports from same reporter. Additional information has been requested.
Age: 2.0
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Registered Nurse regarding multiple unspecified number of patients of unknown age and gender. Information on the concurrent conditions and medical history of the patients were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of VAQTA lot/batch # L048456, expiry date 25-MAY-2017 (dose number, dose units, route and anatomical location were not specified). Concomitant medication were not reported. No adverse effect were reported. There were no product quality Concerns (PQC) involved. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: TYP, YF
Symptoms: Hypoaesthesia, Muscle twitching, Speech disorder
Clinical narrative: Received injection on 6/29/16. On 7/1/16 at approx 1:30pm received a phone call from patient saying she was having numbness and twitching of fingers in right arm and hand. (Inj in Left arm). Said she was having difficulty speaking and her co-worker had called an ambulance.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Musculoskeletal pain, Pain, Pain in extremity, Pruritus
Clinical narrative: Information has been received from a pharmacist referring to a 78 year old female patient with allergy to scallops. Her medical history included prior case of shingles (date unknown) and diarrhea caused by macrolides. On 23-JUN-2016, the patient was vaccinated with a dose of ZOSTAVAX (lot # L046295 with expired date 17-FEB-2017, 0.65 ml, subcutaneous). Concomitant therapy included an unspecified blood pressure medication. On 28-JUN-2016, the patient experienced discomfort in right buttocks and anterior portion of right thigh. The reporter saw the patient on 29-JUN-2016 and noted that she had a red raised area "like a hive" on the anterior right thigh, with itching and 4 to 5 areas "like mosquito bites, in close proximity" on the right buttock. Then the patient was seen by an unspecified dermatologist who diagnosed as "shingles" and prescribed a topical "steroid" cream. The patient was currently experiencing "pain shooting down her right leg". The outcome of the event was reported as not recovered. Causality was not provided. The reporter accepted varicella zoster virus identification program (VZVIP) packet which was faxed. Additional information has been requested.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin oedema, Swelling, Urticaria
Clinical narrative: Information has been received from a pharmacist referring to a 78 year old female patient with allergy to scallops. Her medical history included prior case of shingles (date unknown) and diarrhea caused by macrolides. On 23-JUN-2016, the patient was vaccinated with a dose of ZOSTAVAX (lot # L046295 with expired date 17-FEB-2017, 0.65 ml, subcutaneous). Concomitant therapy included an unspecified blood pressure medication. On 28-JUN-2016, the patient experienced discomfort in right buttocks and anterior portion of right thigh. The reporter saw the patient on 29-JUN-2016 and noted that she had a red raised area "like a hive" on the anterior right thigh, with itching and 4 to 5 areas "like mosquito bites, in close proximity" on the right buttock. Then the patient was seen by an unspecified dermatologist who diagnosed as "shingles" and prescribed a topical "steroid" cream. The patient was currently experiencing "pain shooting down her right leg". The outcome of the event was reported as not recovered. Causality was not provided. The reporter accepted varicella zoster virus identification program (VZVIP) packet which was faxed. Additional information has been requested.
Age: 0.1
Sex: U
Vaccine: RV5
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 4 week old patient of an unknown gender. The patient's concurrent conditions and medical history were not reported. On an unknown date, the 4 week old patient was vaccinated with ROTATEQ orally (strength, frequency, lot number and expiration date were unknown). There were no concomitant therapies provided. No adverse events were reported. Additional information is not expected because no permission to contact the physician was provided.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a office manager refers to patients of unspecified demographics. Reporter stated that doses of improperly stored VAQTA 25/0.5 (units unspecified) (lot number, expiry date unspecified) were administered to unspecified patients on unspecified dates. No adverse events were reported. The outcome was unknown. No product quality complaint was involved. This is one of several reports received from the same reporter. 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 multiple unspecified patients of unknown ages and genders. On unknown dates, the patients were vaccinated with improperly stored ROTATEQ orally (lot # L027719, expiry date: 28-APR-2017; lot # L035637, expiry date: 07-MAY-2018) (incorrect product storage). No adverse effect reported. The outcome of the events was unknown. This is on of the several reports from the same reporter. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This spontaneous prospective pregnancy report was received from a physician and refers to a 25 year old female patient. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On 15-JUN-2016, the patient, who was 4 weeks pregnant, was inadvertently vaccinated with a dose of VARIVAX (lot # K021484, expiration date 03-NOV-2016, exact dose and route of administration were not reported). The patient became pregnant with last menstrual period (LMP) date of 18-MAY-2016 (calculated based on number of pregnancy weeks at the time of report) and estimated date of delivery (EDD) of 22-FEB-2017. No adverse effect was reported. The pregnancy outcome was pending. Additional information has been requested.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Asthenia, Feeling cold, Laboratory test, Nausea, Presyncope
Clinical narrative: Pt. rec'd. BEXSERO #2 in office 06/29/16 approximately 11:00 AM. Rec'd C/from mom at 16:20 stating she had found pt. on ground outside with c/o feeling cold, weak and with N/V (x2). Mom C/'d 911 - Pt. taken to ED and syncope. R/T cardiac hx. (No adverse reactions sot dose #1) Dx as vasovagal reaction.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Syncope, Vomiting
Clinical narrative: Pt. rec'd. BEXSERO #2 in office 06/29/16 approximately 11:00 AM. Rec'd C/from mom at 16:20 stating she had found pt. on ground outside with c/o feeling cold, weak and with N/V (x2). Mom C/'d 911 - Pt. taken to ED and syncope. R/T cardiac hx. (No adverse reactions sot dose #1) Dx as vasovagal reaction.
Age: 70.0
Sex: F
Vaccine: HEP
Symptoms: Dysgeusia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of taste metallic in a 70-year-old female patient who received ENGERIX B adult. The patient's past medical history included lung nodule, lung disorder (near aorta, which had not changed in over 3 years), difficulty breathing (hospitalized), hospitalization (because the patient could not breathe) and adverse drug reaction (Weird reactions). Concurrent medical conditions included sickness (sick for 3 weeks prior to reporting). On an unknown date, the patient received ENGERIX B adult at an unknown dose. On an unknown date, less than a day after receiving ENGERIX B adult, the patient experienced taste metallic. On an unknown date, the outcome of the taste metallic was unknown. It was unknown if the reporter considered the taste metallic to be related to ENGERIX B adult. Additional details were provided as follows: The patient had weird reactions to medications. The reporter stated that, 7 or more years ago the patient was administered with ENGERIX B adult and the patient was left with a metallic taste in her mouth for a couple hours. The reporter did not remember the details. This case has been linked with a case US2016065417, reported by the same reporter.
Age: 15.0
Sex: M
Vaccine: HPV9, MENB
Symptoms: Lethargy, Pain, Pyrexia
Clinical narrative: 3 hours after injection, fever to 103 degrees F with body aches and lethargy.
Age: 16.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Erythema, Peripheral swelling, Skin warm, Tenderness
Clinical narrative: Right arm was warm, red, swollen and tender to the touch. Reaction to GARDASIL 9. Told to apply cold compress.
Age: 52.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pain, Skin warm, Swelling
Clinical narrative: Pt received inj. PREVNAR 13 - 06/17/16 states hurt a lot and afterward - swelling and pain size of tennis ball - red and warm to touch - resolved without treatment called in info 6/22/16.
Age: 73.0
Sex: F
Vaccine: PNC13
Symptoms: Impaired healing, Injection site erythema, Injection site pustule, Injection site reaction, Injection site scab
Clinical narrative: After-1-week site was not healing - Pus and redness was very noticeable. I kept cleaning it. It would scab over, drop off and form again. Doctor looked at it, and set up an apt with dermatologist. One look she diagnosed, skin cancer - removed it and sent to the lab to confirm. Came back "yes" cancer.
Age: 73.0
Sex: F
Vaccine: PNC13
Symptoms: Laboratory test abnormal, Skin cancer
Clinical narrative: After-1-week site was not healing - Pus and redness was very noticeable. I kept cleaning it. It would scab over, drop off and form again. Doctor looked at it, and set up an apt with dermatologist. One look she diagnosed, skin cancer - removed it and sent to the lab to confirm. Came back "yes" cancer.
Age: 36.0
Sex: M
Vaccine: HEPAB, TDAP
Symptoms: Injection site pain, Pain, Pain in extremity
Clinical narrative: PATIENT STATES RIGHT ARM PAINFUL SINCE ADMINISTRATION AND NOW PAIN RADIATING FROM SHOULDER TO NECK (ESPECIALLY PAINFUL WHEN USING ARM.
Age: 12.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Blood test, Computerised tomogram, Menstrual disorder, Ovarian cyst, Ultrasound scan
Clinical narrative: Extreme menstrual cycles. Ovarian Cysts.
Age: 12.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Urine analysis
Clinical narrative: Extreme menstrual cycles. Ovarian Cysts.
Age: 74.0
Sex: M
Vaccine: TDAP, VARZOS
Symptoms: Lip swelling, Rash
Clinical narrative: Patients granddaughter reported the patient was breaking out and felt his lips were swelling. Patient went to ER and got a prescription for prednisone and a possible steroid shot at the ER.
Age: 13.0
Sex: F
Vaccine: HPVX
Symptoms: Arthralgia, Borrelia test, Computerised tomogram, Dysplasia, Ear pain
Clinical narrative: ABOUT 1 YEAR AFTER RECEIVING THE SHOT, SHE STARTING COMPLAING ABOUT JONT PAIN, NUMBING AND TINGLING.. EARACHES. THE JOINT PAIN BECAME VERY WORSE. SHE COULDNT EVEN GET OUT OF BED B Y THE TIME SHE WAS 16. SHE HAS BEEN TESTED FOR EVERYTING. LYME DISEASE, TICK DISEASE, MRI, CAT SCAN, SEEN 2 SPECIALIST. AS OF 2 YEARS AGO SHE NOW HAS 3 ABNORMAL PAPS, SHE HAS MILD DYSPLASIA, CYSTS ON HER OVARIES. IRREGULAR PERIODS, AND CHRONIC PELVIC PAIN. MY ELDEST DAUGHTER WHO DID NOT GET VACCINATED AND IS PERFECTLY HEALTHY.
Age: 13.0
Sex: F
Vaccine: HPVX
Symptoms: Hypoaesthesia, Laboratory test, Menstruation irregular, Mobility decreased, Nuclear magnetic resonance imaging
Clinical narrative: ABOUT 1 YEAR AFTER RECEIVING THE SHOT, SHE STARTING COMPLAING ABOUT JONT PAIN, NUMBING AND TINGLING.. EARACHES. THE JOINT PAIN BECAME VERY WORSE. SHE COULDNT EVEN GET OUT OF BED B Y THE TIME SHE WAS 16. SHE HAS BEEN TESTED FOR EVERYTING. LYME DISEASE, TICK DISEASE, MRI, CAT SCAN, SEEN 2 SPECIALIST. AS OF 2 YEARS AGO SHE NOW HAS 3 ABNORMAL PAPS, SHE HAS MILD DYSPLASIA, CYSTS ON HER OVARIES. IRREGULAR PERIODS, AND CHRONIC PELVIC PAIN. MY ELDEST DAUGHTER WHO DID NOT GET VACCINATED AND IS PERFECTLY HEALTHY.
Age: 13.0
Sex: F
Vaccine: HPVX
Symptoms: Ovarian cyst, Paraesthesia, Pelvic pain, Smear cervix abnormal
Clinical narrative: ABOUT 1 YEAR AFTER RECEIVING THE SHOT, SHE STARTING COMPLAING ABOUT JONT PAIN, NUMBING AND TINGLING.. EARACHES. THE JOINT PAIN BECAME VERY WORSE. SHE COULDNT EVEN GET OUT OF BED B Y THE TIME SHE WAS 16. SHE HAS BEEN TESTED FOR EVERYTING. LYME DISEASE, TICK DISEASE, MRI, CAT SCAN, SEEN 2 SPECIALIST. AS OF 2 YEARS AGO SHE NOW HAS 3 ABNORMAL PAPS, SHE HAS MILD DYSPLASIA, CYSTS ON HER OVARIES. IRREGULAR PERIODS, AND CHRONIC PELVIC PAIN. MY ELDEST DAUGHTER WHO DID NOT GET VACCINATED AND IS PERFECTLY HEALTHY.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Chest discomfort, Fatigue, Malaise, Nasal congestion, Nasopharyngitis
Clinical narrative: Cold symptoms: nasal congestion, chest tightness, cough with clear mucous production, fatigue, sore throat. (treated with o/c products) Date an onset of symptoms are approximate to my recollection. Have been sick with profound Headache, evening fatigue, malaise since vaccination. No other changes in my health.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Oropharyngeal pain, Productive cough
Clinical narrative: Cold symptoms: nasal congestion, chest tightness, cough with clear mucous production, fatigue, sore throat. (treated with o/c products) Date an onset of symptoms are approximate to my recollection. Have been sick with profound Headache, evening fatigue, malaise since vaccination. No other changes in my health.
Age: 42.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Induration, Tenderness
Clinical narrative: WHEN DONOR RETURNED HOME FROM FACILITY NOTED LARGE RED AREA 2X2 WITH A HARD AREA TO CENTER. TENDER TO TOUCH. DONOR STATED APPLIED COLD COMPRESSES TO SITE.
Sex: M
Vaccine: DTP
Symptoms: Anaphylactic reaction
Clinical narrative: Initial unsolicited report received from a pharmacist on 20 June 2016. This case involves a male patient (age not reported) who was vaccinated with a dose of DIPHTHERIA, TETANUS AND PERTUSSIS VACCINE (ADSORBED) (Pertussis Containing Vaccine) (Batch number, expiration date, route and site of administration: not reported) on an unspecified date (reported as many years ago). Illness at time of vaccination, pre-existing physician diagnosed allergies, birth defects, medical conditions were not reported. Concomitant medications were not reported. On an unspecified date, post vaccination the patient experienced anaphylactic reaction to the pertussis containing vaccine. Relevant diagnostic tests/laboratory data and corrective treatment were not reported. On an unspecified date, patient recovered from the event. Upon internal review, the company decided to consider the event serious because of important medical: anaphylactic reaction. List of documents held by sender: none. Sender's Comments: A Male patient reported to have an anaphylactic reaction following DIPHTHERIA, TETANUS AND PERTUSSIS VACCINE (ADSORBED). No further information available in this case. Exact time to onset with the event is unknown. Anaphylaxis can be caused by various factors such as medications, antigen, insect bite, any exposure to chemical, vaccine or its preservative. Dates of vaccination and occurrence of the reported event, patient's past medical history, any concomitant medication, past vaccination history and allergic history are needed to further assess this case. Due to limited available information causality cannot be assessed for now.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Blood test, Dizziness, Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling of 3/4 of upper left arm. Dizziness.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling, Injection site urticaria
Clinical narrative: 2-3 inch diameter raised, red welt with 0.25-0.5 inch white center 1-1.5 inches below injection site of DTaP/IPV on left arm.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to an unspecified number of patients of unknown age and gender. Patients' pertinent medical history and drug reactions or allergies were not reported. On unknown dates, the patients were vaccinated with improperly stored VARIVAX (lot number reported as M002061 and expiration date 12-JAN-2018, lot number M000995 and expiration date 06-JAN-2018, dose and route of administration were not reported). Concomitant therapy was not reported. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of the two 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 Registered Nurse regarding multiple unspecified number of patients of unknown age and gender. Information on the concurrent conditions and medical history of the patients were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB lot L039660, expiry date 04-FEB-2018 (dose number, dose units, route and anatomical location were not specified). Concomitant medication were not reported. No adverse effect were reported. There were no product quality concerns (PQC) involved. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Registered Nurse regarding multiple unspecified number of patients of unknown age and gender. Information on the concurrent conditions and medical history of the patients were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of ROTATEQ lot/batch # L033693 31-MAY-2017 (dose number, dose units, route and anatomical location were not specified). Concomitant medication were not reported. No adverse effect were reported. There were no product quality Concerns (PQC) involved. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Pt received Td Vaccine on 6/25/16 and the following day had swollen, red, painful (3x2in) site at injection on (R) deltoid. Pt developing other symptoms including fever. Pt had been treating it yesterday with ice. Pt will start warm pack and acetaminophen for resolution. Pt will report back if no improvement or worsens.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Immunosuppressant drug therapy, Morphoea, Pathology test
Clinical narrative: Tdap, MENACTRA, and HPV given 7-21-15. Definitely had morphea Aug 2015. Don't known if had before 7-21-15. Immunosuppressives started May 2016.
Age: 46.0
Sex: F
Vaccine: PPV
Symptoms: Headache, Injection site erythema, Nausea, Pain, Pyrexia
Clinical narrative: Arm all red at and around injection site. Pt said she felt nauseous, feverish, headache and body aches starting the evening of the immunization. Pt told to put ice pack on arm and to rest.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, HEP, HEPA
Symptoms: Pyrexia, Seizure
Clinical narrative: Seizure and low grade fever. Seen and evaluated at hospital/doctor.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions/allergies were not provided. On 15-JUN-2016, the patient received an expired dose of VARIVAX (lot # K003414, expiration date 06-MAR-2016, dose was unknown), subcutaneously. No known adverse effects was reported. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report concerning a 61 years old female patient was received from the patient herself. No concurrent conditions were reported. The patient's medical history included a cystometrogram about 10 years ago. The patient had no drug reaction or allergies. On an unknown date in 2015 (reported as "a year ago"), the patient was vaccinated with ZOSTAVAX (strength, dose, frequency, lot and expiration date were not provided) by "injection" route. Concomitant therapies included an unspecified thyroid medication, WELLBUTRIN and VALIUM. On 03-JUN-2016, the patient experienced shingles (herpes zoster). In addition, on an unknown date in June 2016, she had an outpatient visit to the Hospital because the event became more severe on an unspecified date. The patient was prescribed with hydrocodone by the attending physician. No laboratory diagnostic studies were performed. No product quality complain was involved. At the time of reporting, the outcome of the event of herpes zoster was reported as not recovered. The causality between the event of herpes zoster and ZOSTAVAX was not assessed. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Product quality issue, Underdose
Clinical narrative: This report has been received from the healthcare professional and refers to a patient of unknown age and gender enrolled in patient support program. On an unknown date, the patient was vaccinated with MMR II (dose, frequency and route of administration were not reported). On an unknown date, during administration, the vaccine shot back out which caused dose to came out. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report concerning a patient of an unknown gender and age was received from a physician via company representative. Concurrent conditions and medical history were not provided. On an unknown date, the patient was vaccinated with GARDASIL 9 (strength, dose, route, frequency, lot and expiration date were not provided) and then, on an unknown date, was vaccinated with GARDASIL (strength, dose, route, frequency, lot and expiration date were not provided) (interchange of vaccine products). No concomitant medications and adverse events were reported. No product quality complain was involved. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to an 18 year old female patient. The patient had no concurrent or historical condition. No drug reactions or allergies were reported. On 06-JUN-2016 the patient was vaccinated with a dose of (Oka/Merck) VARIVAX (lot # L049532 with expired date 08-DEC-2017, subcutaneous, dose unknown) to prevent chickenpox. However, the patient was already 22 weeks pregnant that day (exposure during pregnancy and product use issue). The last menstrual period (LMP) was 03-JAN-2016 and estimated due date (EDD) was 09-OCT-2016. No known adverse effects. No concomitant therapy was reported. No lab diagnostics study was performed. Additional information has been requested.
Age: 59.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Pain
Clinical narrative: Swelling and redness at injection site, and around the upper arm, and into armpit.  Normal pain/redness after injection, but additional swelling noted next day.  Symptoms getting better when pt. reported on 7/5/16, but redness and swelling still present.  Pt. going to MD 7/6/16 for unrelated appt.  Will monitor and have MD examine tomorrow.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse practitioner referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 01-JUN-2016 the patient was vaccinated with GARDASIL 9 (dose and route not reported, lot # M003659, expiration date 20-SEP-2017). Concomitant therapy was not reported. The vaccine was exposed to temperature excursion of 27.9 degrees Fahrenheit (F) for 20 hours 53 minutes and 41.7 F for 12 minutes. Data logger was involved. It was also reported that there was no previous temperature excursion. No adverse effects were reported. This is one of two reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Guillain-Barre syndrome
Clinical narrative: This spontaneous report was received from a physician via company representative concerning a patient of unknown age and gender. No medical history and concurrent conditions were reported. On an unknown date, the patient was vaccinated with the first dose of GARDASIL 9, (lot number and expiry date unknown) (dosing regimen and frequency unknown). No concomitant medications were reported. On an unknown date, the patient experienced Guillain-Barre syndrome. The outcome of Guillain-Barre syndrome was reported as recovered on an unknown date. The reporter did not assess the causality of the event with GARDASIL 9. Upon internal review Guillain-Barre syndrome was determined to be medically significant. Additional information is not expected since the reporter did not wish to be contacted for further follow up.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 14-JUN-2016 the patient received a dose of improperly stored VARIVAX (lot # L041206, expiration date 20-OCT-2017). No adverse effects reported. This is one of the two reports received from the same reporter. Additional information has been requested.