chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 11.0
Sex: M
Vaccine: HEPA, HPV9, MNQ, TDAP
Symptoms: Pallor, Posture abnormal, Throat tightness, Vomiting
Clinical narrative: Client c/o dizziness and states "I'm going to pass out". Head lowered between legs, but client began to slump to side. FOC lowered client to the ground with RN assistance. Legs placed up on chair. Client's eyes remained open during episode and responded to his name after 3-5 seconds and client asked "what happened". Color beginning to return to face. Moved client from ground back up to chair at 10:15 and ice back applied to back of neck as cold compress. Water provided. Client c/o nausea. Continued to keep client's head between legs in chair. Client begins to shiver at 10:18. Granola bar offered and client takes 1 bite and vomits. 10:25 client continues to feel nauseous and states his legs feel weak. Moved to ground with legs elevated on chair. Pulse = 70. Client states he continues to go through periods where he "feels better" and then "feels nauseous". 10:40 911 called. RN comes into room. At 10:43, client c/o tightness in throat. 10:45- 0.4 cc epinephrine administered in left thigh by RN. Within 30 seconds of epinephrine, client states he "feels much better" and denies tightness in throat. Client continues to remain on ground with legs elevated and is conversing with FOC. 10:50 EMS arrives and evaluates. FOC declines transport to hospital. EMS instructs FOC to take client to PCP ASAP. FOC agrees. Client walked out of clinic on his own at 11:30am.
Age: 16.0
Sex: M
Vaccine: HPV9, MNQ, TDAP, VARCEL
Symptoms: Deafness, Hyperhidrosis, Loss of consciousness, Nasopharyngitis, Pallor
Clinical narrative: Blackout, sweating, hearing loss, cold/pale. Symptoms lasting for a few minutes. No treatment necessary.
Age: 86.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Hypersensitivity, Local reaction, Pyrexia, Swelling
Clinical narrative: Localized reaction, swelling, redness to area. Appears to be allegic reaction, mild fever.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Activities of daily living impaired, Arthralgia, Mobility decreased, Rotator cuff syndrome
Clinical narrative: Extreme pain in joint. Cannot use arm to take off clothing. Diagnosed 08/04/2015 and rotator cuff tendonitis.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Fall, Pallor, Tremor
Clinical narrative: AFTER VACCINATIONS WERE GIVEN BY PROVIDER, IT WAS NOTED INJECTION REACTION IN PT WAS PALE, HAD SOME SHAKINESS, PROVIDER GAVE WATER AND PT WAS INSTRUCTED TO SIT IN CHAIR TO REGAIN HER COMPOSURE, I ENTERED THE ROOM AS PROVIDER LEFT. PT STATED THAT SHE WAS FEELING BETTER, STOOD TO GET MORE WATER, FELT OK, TURNED TO SIT IN CHAIR THAT IS WHEN SHE LOST ALL COLOR IN HER FACE, STARTED TO SHAKE AND AS SHE BEGAN TO FALL TO THE FLOOR I IMMEDIATELY KNEW WHAT WAS HAPPENING, HAD PT FALL TOWARDS MYSELF AND LOWERED HER TO THE FLOOR, WHERE THE PROVIDER WAS CALLED TO THE ROOM, A PILLOW WAS PLACED UNDER THE PT'S HEAD AND WE TALKED TO HER UNTIL SHE REGAINED FULL CONSCIOUSNESS, PLACING A COOL WET TOWEL TO HER FOREHEAD. PT CONTINUED TO LAY ON THE FLOOR UNTIL SHE WAS ABLE TO SIT UP WITH OUT FURTHER REACTIONS, THEN SHE WAS ALLOWED TO STAND NEAR ME. DURING THAT PROCESS THE PT REGAINED COLOR IN HER FACE AND WAS TALKING AND JOKING WITH HER SISTER WHO WITNESSED THE EPISODE. PT WAS INSTRUCTED TO SIT UNTIL THE PROVIDER AND MYSELF FELT THAT SHE COULD WALK UNASSISTED WITH HER MOTHER AND SISTER. PT WAS NOT INJURED WHEN SHE WAS LOWERED TO THE FLOOR.
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Burning sensation, Erythema, Pruritus
Clinical narrative: I woke up with a red, burning/itchy in the same arm as the injection site that then spread on my back and down my sides. This itchy/burn lasted many days and was only calmed by the use of fluocinonide 0.05 % ointment.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Pain, Pyrexia
Clinical narrative: Fever/achiness.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Asthenia, Diarrhoea, Dizziness, Dyspnoea, Erythema
Clinical narrative: PATIENT REPORTED THAT 30 MINUTES AFTER ADMINISTRATION SHE EXPERIENCED WEAKNESS, DIZZINESS, NAUSEA, DIARRHEA  SHORTNESS OF BREATH, AND RED ITCHY HANDS WHICH LASTED 30-45 MINUTES. ONE HOUR AFTER THE ADMINISTRATION, HER SYMPTOMS HAD RESOLVED WITHOUT TREATMENT.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Nausea, Pruritus
Clinical narrative: PATIENT REPORTED THAT 30 MINUTES AFTER ADMINISTRATION SHE EXPERIENCED WEAKNESS, DIZZINESS, NAUSEA, DIARRHEA  SHORTNESS OF BREATH, AND RED ITCHY HANDS WHICH LASTED 30-45 MINUTES. ONE HOUR AFTER THE ADMINISTRATION, HER SYMPTOMS HAD RESOLVED WITHOUT TREATMENT.
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Diarrhoea, Hyperhidrosis, Injected limb mobility decreased, Injection site pain, Injection site swelling
Clinical narrative: Significant swelling to injection site; pain and immobility at injection site; fevers; diaphoresis; diarrhea.
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Significant swelling to injection site; pain and immobility at injection site; fevers; diaphoresis; diarrhea.
Age: 12.0
Sex: F
Vaccine: DTAP, HPVX
Symptoms: Dizziness, Nausea, Syncope, Vomiting
Clinical narrative: Dizzy, nausea, then fainted. Vomited.
Age: 36.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Infection, Local swelling, Pyrexia, Skin warm
Clinical narrative: Localization of redness, warmth, swelling and fever. Subsequently developed infection requiring IV antibiotics.
Age: 66.0
Sex: M
Vaccine: PNC13
Symptoms: Abdominal pain, Eyelid ptosis, Hypoaesthesia
Clinical narrative: Vaccine received by patient on July 17, 2015 he developed abdominal pain on July 24, 2015, went to the ER July 25, 2015, developed hand numbness and ptosis on July 26, 2015. He was admitted to the hospital July 26, 2015 and is now in rehab.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling
Clinical narrative: Most of arm swollen, patient sought urgent care treatment.
Age: 11.0
Sex: F
Vaccine: HEP, HEPA, HPV4, MNQ, TDAP
Symptoms: Computerised tomogram head, Cyanosis, Electrocardiogram, Electroencephalogram, Fall
Clinical narrative: Pt seen in office for 11yr PE. Requiring 5 vaccines. Mom wanted to pt to receive them all. All 5 admin. pt told to wait x 15 min post vaccine. Pt stood up and walked to other side of room. 1 min later pt fell over & hit head on wall. Eye deviation & circumoral cyanosis, came to quickly after MD in to assess. Rescue called. Take to ER.
Age: 11.0
Sex: F
Vaccine: HEP, HEPA, HPV4, MNQ, TDAP
Symptoms: Full blood count, Gaze palsy, Head injury, Metabolic function test
Clinical narrative: Pt seen in office for 11yr PE. Requiring 5 vaccines. Mom wanted to pt to receive them all. All 5 admin. pt told to wait x 15 min post vaccine. Pt stood up and walked to other side of room. 1 min later pt fell over & hit head on wall. Eye deviation & circumoral cyanosis, came to quickly after MD in to assess. Rescue called. Take to ER.
Age: 45.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain, Pyrexia, Swelling
Clinical narrative: Fever, body aches, soreness, redness, swelling.
Age: 3.0
Sex: F
Vaccine: DTAPIPVHIB, MMR, PNC13, VARCEL
Symptoms: Body temperature increased, Injection site erythema, Injection site induration, Injection site nodule, Injection site warmth
Clinical narrative: 1 1/2 after vaccines given, child developed a generalized pustule rash, worse to upper legs and trunk. On an off fever-a high temp of 103.2. Current temp 97 degrees. Mother gave child MOTRIN, red, warm, hard knot to (R) upper leg injection site 20mm x 10mm.
Age: 3.0
Sex: F
Vaccine: DTAPIPVHIB, MMR, PNC13, VARCEL
Symptoms: Rash generalised, Rash pustular
Clinical narrative: 1 1/2 after vaccines given, child developed a generalized pustule rash, worse to upper legs and trunk. On an off fever-a high temp of 103.2. Current temp 97 degrees. Mother gave child MOTRIN, red, warm, hard knot to (R) upper leg injection site 20mm x 10mm.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Rash pustular
Clinical narrative: 1 1/2 days after vaccine given, child developed a pustule rash (L) leg > (R) leg; Couple pustules to face, (R) arm & (L) wrist. No fever reported. Current temp 98.6.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Vaccine received 7/29; by 7/31/15 area was red, raised, warm, itching, and baseball size. Patient was seen by physician 7/31/15 then treated for cellulitis.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: Redness, edema, warmth at administration site.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Pt got the shot (ZOSTAVAX) on 7/27/15 and came in 7/30/15 stated her injection site about half dollar size, tender was red, achy. Pt took ibuprofen, I told her to contact MD if it doesn't go away. Spoke to pt on 8/2-she is okay.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Rash erythematous, Rash generalised
Clinical narrative: Shots administered at 10:30 AM on 8/3/15. On 8/4/15 mom called to report that child had rash all over. Advised mom to bring child in for assessment. This nurse notes tympanic temp of 97.6 degrees F, rash of small red pimple sized dots from about waistline and down bilat legs.
Age: 50.0
Sex: F
Vaccine: HEP
Symptoms: Lip swelling, Rash, Urticaria
Clinical narrative: Hepatitis B vaccine administered 7/24/15 (3rd in the series) (2:30 pm) no previous reaction. Next A.M. reports bumps near vaccine side that progressed to elbow midday. Hospital prescribed BENADRYL PO and topical ointment. Next day rash raised and progressed to (L) side of chest area Sat welts/Sunday 8/2 lips swollen-ER visit-IV BENADRYL prednisone, antibiotic ointment. Monday 8/3-improved.
Age: 71.0
Sex: F
Vaccine: PNC13, TD
Symptoms: Cellulitis, Erythema, Skin warm, Tenderness
Clinical narrative: Redness, warmth, tenderness consistent with a cellulitis. Noticed June 3, 2015. Seen in office June 9, 2015. Given KEFLEX 250mg 4 x daily for 7 days.
Age: 6.0
Sex: M
Vaccine: DTAP, IPV, MMRV, PNC13
Symptoms: Abasia, Erythema, Lacrimation increased, Pyrexia
Clinical narrative: Onset of fever, watering eyes, facial redness and "he could not walk at all" on 6.26.2015 per mother's report. Fever of 102.7. Mother treated child with over the counter liquid TYLENOL and patients' symptoms ended on 6/28/2015 and he was able to walk again.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV, VARCEL
Symptoms: Extra dose administered
Clinical narrative: Administered PROQUAD and Varicella at same visit.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper, Pain, Pyrexia, Urine analysis normal
Clinical narrative: Fever to 102.5, body aches and belly pain one day after vaccine administration.
Age: 0.3
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5
Symptoms: Fontanelle bulging, Irritability, Ultrasound scan normal, VIth nerve paralysis
Clinical narrative: 4 mo old F-developed fussiness, bulging fontanelle, 6th nerve palsy within hours of vaccine-PENTACEL, ROTATEQ, PREVNAR. Symptoms lasted 6 days.
Age: 0.3
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5
Symptoms: Agitation, Fontanelle bulging, Inappropriate schedule of drug administration, Pyrexia, Ultrasound scan
Clinical narrative: 4 mo old F-developed fussiness, bulging fontanelle, 6th nerve palsy within hours of vaccine-PENTACEL, ROTATEQ, PREVNAR. Symptoms lasted 6 days.
Age: 0.3
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5
Symptoms: VIth nerve paralysis
Clinical narrative: 4 mo old F-developed fussiness, bulging fontanelle, 6th nerve palsy within hours of vaccine-PENTACEL, ROTATEQ, PREVNAR. Symptoms lasted 6 days.
Age: 0.3
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5
Symptoms: Fontanelle bulging, Pyrexia, Ultrasound skull abnormal, VIth nerve paralysis
Clinical narrative: 4 mo old F-developed fussiness, bulging fontanelle, 6th nerve palsy within hours of vaccine-PENTACEL, ROTATEQ, PREVNAR. Symptoms lasted 6 days.
Age: 0.3
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5
Symptoms: Fontanelle bulging, Hypermetropia, Irritability, Pseudostrabismus, Strabismus
Clinical narrative: 4 mo old F-developed fussiness, bulging fontanelle, 6th nerve palsy within hours of vaccine-PENTACEL, ROTATEQ, PREVNAR. Symptoms lasted 6 days.
Age: 0.3
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5
Symptoms: Fontanelle bulging, Irritability, VIth nerve paralysis
Clinical narrative: 4 mo old F-developed fussiness, bulging fontanelle, 6th nerve palsy within hours of vaccine-PENTACEL, ROTATEQ, PREVNAR. Symptoms lasted 6 days.
Age: 0.21
Sex: M
Vaccine: HEPA, HIBV, MMR, PNC13
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: There were no adverse events at the time of vaccinations were given. We will be following up with the baby over the next couple of days (daily) to make sure he is doing okay.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Discomfort, Pyrexia, Rash
Clinical narrative: Rash on upper and lower extremities, fever of 102. Treatment: TYLENOL as needed for fever/discomfort.
Age: 43.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Pruritus, Rash
Clinical narrative: Itching and rash on chest, under bilateral breast, back and neck for past four days, since Friday morning 7/31/15.
Age: 11.0
Sex: F
Vaccine: HPV9, HPV4
Symptoms: Electroencephalogram normal, Generalised tonic-clonic seizure
Clinical narrative: Had HPV#2 on 6/1/2015 17 days later had GTC seizure. Had HPV #3 on 7/29/2015 1 day later had GTC seizure and had another GTC seizure today 8/3/2015.
Age: 11.0
Sex: F
Vaccine: HPV9, HPV4
Symptoms: Computerised tomogram, Electroencephalogram, Epilepsy, Generalised tonic-clonic seizure, Nuclear magnetic resonance imaging
Clinical narrative: Had HPV#2 on 6/1/2015 17 days later had GTC seizure. Had HPV #3 on 7/29/2015 1 day later had GTC seizure and had another GTC seizure today 8/3/2015.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Decreased appetite, Discomfort, Head discomfort, Hyperacusis, Nausea
Clinical narrative: No fever. No visual changes. Within 12 hours of immunization, developed severe constant pressure in back of neck and entire head, had sound sensitivity and nausea. All symptoms resolved by 24 hours after immunization except anorexia which persisted until 48 hours after immunization.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Hearing impaired, Pallor, Slow response to stimuli, Visual impairment
Clinical narrative: Teen arrived in office at 3:16pm to receive HPV#2. Temp 98.8 & teen denied any reaction after first vaccine. Vaccine given & when checking out, child started to feel faint, dizzy, difficulty hearing & seeing. Initial vitals taken at approx. 3:35pm in the waiting room as teen was sitting down. Teen then walked w/assistance to lay down. At this time, teen admitted to feeling faint on the ride home after receiving first vaccine in May. Teen cont'd to c/o difficulty seeing "everything going light & dark" & unable to hear well. CRNP, RN, LPN and Dr in exam room. Child cont'd to feel dizzy, difficulty hearing & seeing and BP elevated 30 min after onset of symptoms. Last BP 156/100, teen alert & oriented but slow to respond, starting off into space & pale. EMS called at 3:57pm. Report called to ER. EMS arrived at 4:06pm. Teen taken to medical center via EMS.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to an unspecified patient of unknown age and gender. No medical history and concurrent conditions were reported. On 30-JUL-2015, the patient was inadvertently vaccinated with expired dose of VARIVAX (Merck) injection (lot # J003705 and expiry date: 27-MAR-2015) (dose and site of administration not reported). No concomitant medications were reported. No adverse events were experienced. The outcome of the reported events was unknown. No product quality complaint (PQC) was filed. No additional information was provided. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a Certified Medical Assistant refers to a 5 year old male patient. Concurrent conditions and medical history were not reported. The reporter informed that on 01-AUG-2015, the patient was vaccinated with an expired dose of M-M-R II Injection, 0.5 mL subcutaneously in the right arm, lot # J006185, expiration date 24-MAY-2015. No adverse effects were reported and no Product Quality Complaint (PQC) was involved. Additional information is not expected as the reporter did not wish to be contacted for further follow-up.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of an unkonwn age  and gender. The patient's concurrent conditions and medical history were not reported. On 31-JUL-2015, the patient was inadvertently vaccinated with VARIVAX (Merck) (unknown strength and route) which expired on 30-MAY-2015. Concomitant medications were not reported. No adverse effects were reported. The outcome of the event was unknown. There was no product quality complaint involved. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to a patient of unknown age and gender. No concurrent condition or medical history was reported. On 16-JUL-2015, the patient was inadvertently vaccinated with 3rd dose of VARIVAX (Merck) (dose and route of administration not provided) (extra dose administered). No concomitant therapy was reported. No adverse effects were reported. The outcome of the event was unknown. No product quality issue was involved. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Pyrexia
Clinical narrative: This spontaneous report was received from a physician via company representative refers to a 13 year old female patient. No concurrent condition or medical history was reported. On an unknown date the patient was vaccinated with GARDASIL 9 (dose 1, dose and route of administration not provided). No concomitant therapy was reported. It was reported that the patient developed fever after getting vaccine. The patient did not sought medical attention. The patient plans to continue with the GARDASIL 9 vaccine series. The outcome of pyrexia was reported as recovered. The causality assessment was not reported. No product quality issue was involved. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a pharmacist and a registered nurse concerning a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 31-JUL-2015 (today), the patient was vaccinated with an expired dose of VARIVAX (Merck) lot# reported as K006960, expiration date 24-JUL-2015 (dose and route not reported). No adverse effects were reported. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, these patients was vaccinated with improperly stored doses of M-M-R II (lot # K016153 with expiration date 24-SEP-2016 and lot # K021151 with expiration date 02-NOV-2016; dose and route of administration were not reported)(Incorrect product storage). No adverse effects were reported. Follow up information has been received from the medical assistant concerning the 4 years old male patient on 27-JUL-2015. On 17-JUN-2015 the patient was vaccinated with an improperly stored dose of M-M-R II (lot # K021151, expiration date 02-NOV-2016, rHA) (incorrect product storage). Additional information has been requested. Patient demographic, product, adverse event and narrative were updated.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a physician via a company representative concerning a patient of unknown age and gender. No relevant medical conditions were reported. On an unknown date, the patient was vaccinated with the second dose of GARDASIL intramuscularly (strength, dose, lot# and expiration date not reported) one year later than the first dose (inappropriate schedule of vaccine administration). No adverse effects were reported. Additional information is not expected since the reporting physician did not want to be contacted.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to an unspecified number of patients of unknown age and gender. The patients' concurrent condition and medical history were not reported. On unknown dates the patients were vaccinated with improperly stored GARDASIL (strength, dose, frequency and route were unknown, lot # K008931, expiration date 04-MAR-2017). No symptoms were reported. This is one of several reports from the same reporter. Additional information is not expected as the reporter asked not to be contacted.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse concerning to an unspecified number of patients of unknown age and gender. Information regarding the patients' medical history, concurrent conditions or concomitant therapy was not provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDAIL 9 (strength, dose, interval and route of administration were not reported) lot # K026246 with expiration date of 28-JAN-2017. No adverse events or product quality complaints (PQC) were reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse concerning to an unspecified number of patients of unknown age and gender. Information regarding the patients' medical history, concurrent conditions or concomitant therapy was not provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL (strength, dose, interval and route of administration were not reported) lot # K007828 with expiration date of 08-APR-2017 and lot number K007828 with expiration date of 02-MAR-2017. No adverse events or product quality complaints (PQC) were reported. This is one of several reports from the same reporter. 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 medical assistant refers to a patient of unknown age and gender. On an unspecified date in September 2012, the patient was vaccinated with the first dose of GARDASIL (dose, route and lot # not reported). On 29-MAR-2013, the patient received the second dose of GARDASIL (dose, route and lot # not reported) and on 02-MAY-2013, the patient received the third dose of GARDASIL (dose, route and lot # not reported). No adverse effects were reported. 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 concerning to an unspecified number of patients of unknown age and gender. Information regarding the patients' medical history, concurrent conditions or concomitant therapy was not provided. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (strength, dose, interval and route of administration were not reported) lot number: K022265 with expiration date of 22-OCT-2016 and lot number: K010216 with expiration date of: 17-SEP-2016. No adverse events or product quality complaints (PQC) were reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse concerning to an unspecified number of patients of unknown age and gender. Information regarding the patients' medical history, concurrent conditions or concomitant therapy was not provided. On unknown dates, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 (strength, dose, interval and route of administration were not reported) lot number: K008410 with expiration date of: 26-FEB-2016. No adverse events or product quality complaints (PQC) were reported. This is one of several reports 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 was received from a registered nurse concerning to an unspecified number of patients of unknown age and gender. Information regarding the patients' medical history, concurrent conditions or concomitant therapy was not provided. On unknown dates, the patients were vaccinated with improperly stored doses of VAQTA (strength, dose, interval and route of administration were not reported) lot number: K005958 with expiration date of: 09-FEB-2017 and lot number: K012457 with expiration date of 04-JUN-2017. No adverse events or product quality complaints (PQC) were reported. This is one of 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 concerning to an unspecified number of patients of unknown age and gender. Information regarding the patients' medical history, concurrent conditions or concomitant therapy was not provided. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ (strength, dose, interval and route of administration were not reported) (lot/batch number reported as K016263, expiration date: 26-JUN-2016). No adverse events or product quality complaints (PQC) were reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Biopsy skin, Rash, Rash erythematous, Rash macular, Scar
Clinical narrative: This spontaneous report was received from a female patient of unknown age, reporting on herself. Information regarding the patient's medical history, concurrent conditions or concomitant therapy was not provided. On September 2014, the patient was vaccinated with ZOSTAVAX Subcutaneous injection (strength, dose, lot number and expiration date were not provided). Subsequently, after the vaccination, the patient experienced red patches of skin all over her legs. At the time of reporting, she had dark scars from where the red patches were. The patient reported that she had a large biopsy taken out of her leg (results not provided) and her physician confirmed that her red patches were a reaction to the ZOSTAVAX vaccine. The patient tried to use creams for her scars but it resulted in her legs having dark blotches everywhere. No product quality complaints were reported. At the time of this report, the outcome of hypersensitivity, rash maculo-papular and scar was unknown. It was considered that hypersensitivity was related to ZOSTAVAX. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Vaccination complication
Clinical narrative: This spontaneous report was received from a female patient of unknown age, reporting on herself. Information regarding the patient's medical history, concurrent conditions or concomitant therapy was not provided. On September 2014, the patient was vaccinated with ZOSTAVAX Subcutaneous injection (strength, dose, lot number and expiration date were not provided). Subsequently, after the vaccination, the patient experienced red patches of skin all over her legs. At the time of reporting, she had dark scars from where the red patches were. The patient reported that she had a large biopsy taken out of her leg (results not provided) and her physician confirmed that her red patches were a reaction to the ZOSTAVAX vaccine. The patient tried to use creams for her scars but it resulted in her legs having dark blotches everywhere. No product quality complaints were reported. At the time of this report, the outcome of hypersensitivity, rash maculo-papular and scar was unknown. It was considered that hypersensitivity was related to ZOSTAVAX. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster disseminated, Secondary transmission
Clinical narrative: This initial spontaneous report was received from a physician through a field representative, referring to a male patient of unknown age. Patient's concurrent conditions included bone marrow transplant. Other medical history was not reported. On an unknown date, the patient's wife (a 65 year old female) was vaccinated with ZOSTAVAX injection (dose, route, lot number and expiration date not provided). There was no concomitant medication described. Subsequently, she transmitted the herpes zoster virus to her husband which was at home as a bon marrow transplant patient. It was considered as a secondary transmission as the patient did not receive his own vaccination with ZOSTAVAX. Later, the patient developed disseminated herpes zoster which was treated at specified hospital. At the time of the report, the outcome of secondary transmission and herpes zoster disseminated was reported as recovered. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Therapeutic response decreased
Clinical narrative: This spontaneous report as received from a consumer via HRA as part of market research program (1110-X686) refers to an unspecified number of immunocompromised patients of unknown age and gender. Concurrent conditions and medical history were not reported. On an unknown date, the patients were vaccinated with a dose of PNEUMOVAX 23 (lot number, expiration date, strength, dose and route were not reported). Concomitant medications were not reported. The reporter stated that, on an unknown date, the patients may had had a decreased response to PNEUMOVAX 23. The outcome of therapeutic response decreased was unknown at the time of the report. The reporter did not assess the relatedness of PNEUMOVAX 23 to therapeutic response decreased. Additional information has been requested.
Age: 14.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Blood test normal, Cardiac monitoring normal, Electrocardiogram normal, Electroencephalogram normal, Exercise tolerance decreased
Clinical narrative: This spontaneous report was received from a physician and refers to a 14 year old male patient. No medical history and concurrent conditions were reported. On following dates 09-APR-2015, 02-DEC-2014 and 09-APR-2015, the patient was vaccinated with GARDASIL (lot # K006960 and expiry date: 14-JAN-2017), (lot: K006960; expiration: 19-FEB-2017) and (lot: K006960; expiration: 19-FEB-2017) respectively intramuscular injection. It was unspecified whether GARDASIL vials or pre-filled syringes were used for these doses. No concomitant medications were reported. On 18-APR-2015, the patient experienced heat intolerance, exercise intolerance and fatigue. The patient also had fainting episodes following exercise on 18-APR-2015, 15-MAY-2015 and on 15-JUN-2015. On 06-JUL-2015, the patient experienced diaphoresis and hyperventilation. On unspecified dates laboratory tests blood chemistry and complete blood count (CBC), electrocardiogram (EKG), Holter monitor, one month cardiac event monitor, and electroencephalogram (EEG) were performed and reported as normal. It was unspecified how long it took for the patient to recover from these fainting episodes, hyperhidrosis and hyperventilation and recovered in 2015. The action taken with GARDASIL was not reported. The outcome of heat intolerance, fatigue and exercise intolerance was reported as not recovered/not resolved. The causality was not reported. No further information provided. No product quality complaint (PQC) was filed. Additional information has been requested.
Age: 14.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Fatigue, Full blood count normal, Hyperhidrosis, Hyperventilation, Syncope
Clinical narrative: This spontaneous report was received from a physician and refers to a 14 year old male patient. No medical history and concurrent conditions were reported. On following dates 09-APR-2015, 02-DEC-2014 and 09-APR-2015, the patient was vaccinated with GARDASIL (lot # K006960 and expiry date: 14-JAN-2017), (lot: K006960; expiration: 19-FEB-2017) and (lot: K006960; expiration: 19-FEB-2017) respectively intramuscular injection. It was unspecified whether GARDASIL vials or pre-filled syringes were used for these doses. No concomitant medications were reported. On 18-APR-2015, the patient experienced heat intolerance, exercise intolerance and fatigue. The patient also had fainting episodes following exercise on 18-APR-2015, 15-MAY-2015 and on 15-JUN-2015. On 06-JUL-2015, the patient experienced diaphoresis and hyperventilation. On unspecified dates laboratory tests blood chemistry and complete blood count (CBC), electrocardiogram (EKG), Holter monitor, one month cardiac event monitor, and electroencephalogram (EEG) were performed and reported as normal. It was unspecified how long it took for the patient to recover from these fainting episodes, hyperhidrosis and hyperventilation and recovered in 2015. The action taken with GARDASIL was not reported. The outcome of heat intolerance, fatigue and exercise intolerance was reported as not recovered/not resolved. The causality was not reported. No further information provided. No product quality complaint (PQC) was filed. Additional information has been requested.
Age: 14.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Temperature intolerance
Clinical narrative: This spontaneous report was received from a physician and refers to a 14 year old male patient. No medical history and concurrent conditions were reported. On following dates 09-APR-2015, 02-DEC-2014 and 09-APR-2015, the patient was vaccinated with GARDASIL (lot # K006960 and expiry date: 14-JAN-2017), (lot: K006960; expiration: 19-FEB-2017) and (lot: K006960; expiration: 19-FEB-2017) respectively intramuscular injection. It was unspecified whether GARDASIL vials or pre-filled syringes were used for these doses. No concomitant medications were reported. On 18-APR-2015, the patient experienced heat intolerance, exercise intolerance and fatigue. The patient also had fainting episodes following exercise on 18-APR-2015, 15-MAY-2015 and on 15-JUN-2015. On 06-JUL-2015, the patient experienced diaphoresis and hyperventilation. On unspecified dates laboratory tests blood chemistry and complete blood count (CBC), electrocardiogram (EKG), Holter monitor, one month cardiac event monitor, and electroencephalogram (EEG) were performed and reported as normal. It was unspecified how long it took for the patient to recover from these fainting episodes, hyperhidrosis and hyperventilation and recovered in 2015. The action taken with GARDASIL was not reported. The outcome of heat intolerance, fatigue and exercise intolerance was reported as not recovered/not resolved. The causality was not reported. No further information provided. No product quality complaint (PQC) was filed. Additional information has been requested.
Age: 14.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Balance disorder, Blepharospasm, Blood test normal, Cardiac monitoring normal, Cardiac murmur functional
Clinical narrative: This spontaneous report was received from a physician and refers to a 14 year old male patient. No medical history and concurrent conditions were reported. On following dates 09-APR-2015, 02-DEC-2014 and 09-APR-2015, the patient was vaccinated with GARDASIL (lot # K006960 and expiry date: 14-JAN-2017), (lot: K006960; expiration: 19-FEB-2017) and (lot: K006960; expiration: 19-FEB-2017) respectively intramuscular injection. It was unspecified whether GARDASIL vials or pre-filled syringes were used for these doses. No concomitant medications were reported. On 18-APR-2015, the patient experienced heat intolerance, exercise intolerance and fatigue. The patient also had fainting episodes following exercise on 18-APR-2015, 15-MAY-2015 and on 15-JUN-2015. On 06-JUL-2015, the patient experienced diaphoresis and hyperventilation. On unspecified dates laboratory tests blood chemistry and complete blood count (CBC), electrocardiogram (EKG), Holter monitor, one month cardiac event monitor, and electroencephalogram (EEG) were performed and reported as normal. It was unspecified how long it took for the patient to recover from these fainting episodes, hyperhidrosis and hyperventilation and recovered in 2015. The action taken with GARDASIL was not reported. The outcome of heat intolerance, fatigue and exercise intolerance was reported as not recovered/not resolved. The causality was not reported. No further information provided. No product quality complaint (PQC) was filed. Additional information has been requested.
Age: 14.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Computerised tomogram head normal, Dehydration, Diarrhoea, Differential white blood cell count normal, Diplopia
Clinical narrative: This spontaneous report was received from a physician and refers to a 14 year old male patient. No medical history and concurrent conditions were reported. On following dates 09-APR-2015, 02-DEC-2014 and 09-APR-2015, the patient was vaccinated with GARDASIL (lot # K006960 and expiry date: 14-JAN-2017), (lot: K006960; expiration: 19-FEB-2017) and (lot: K006960; expiration: 19-FEB-2017) respectively intramuscular injection. It was unspecified whether GARDASIL vials or pre-filled syringes were used for these doses. No concomitant medications were reported. On 18-APR-2015, the patient experienced heat intolerance, exercise intolerance and fatigue. The patient also had fainting episodes following exercise on 18-APR-2015, 15-MAY-2015 and on 15-JUN-2015. On 06-JUL-2015, the patient experienced diaphoresis and hyperventilation. On unspecified dates laboratory tests blood chemistry and complete blood count (CBC), electrocardiogram (EKG), Holter monitor, one month cardiac event monitor, and electroencephalogram (EEG) were performed and reported as normal. It was unspecified how long it took for the patient to recover from these fainting episodes, hyperhidrosis and hyperventilation and recovered in 2015. The action taken with GARDASIL was not reported. The outcome of heat intolerance, fatigue and exercise intolerance was reported as not recovered/not resolved. The causality was not reported. No further information provided. No product quality complaint (PQC) was filed. Additional information has been requested.
Age: 14.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Disorientation, Dizziness, Dysstasia, Echocardiogram normal, Electrocardiogram ambulatory normal
Clinical narrative: This spontaneous report was received from a physician and refers to a 14 year old male patient. No medical history and concurrent conditions were reported. On following dates 09-APR-2015, 02-DEC-2014 and 09-APR-2015, the patient was vaccinated with GARDASIL (lot # K006960 and expiry date: 14-JAN-2017), (lot: K006960; expiration: 19-FEB-2017) and (lot: K006960; expiration: 19-FEB-2017) respectively intramuscular injection. It was unspecified whether GARDASIL vials or pre-filled syringes were used for these doses. No concomitant medications were reported. On 18-APR-2015, the patient experienced heat intolerance, exercise intolerance and fatigue. The patient also had fainting episodes following exercise on 18-APR-2015, 15-MAY-2015 and on 15-JUN-2015. On 06-JUL-2015, the patient experienced diaphoresis and hyperventilation. On unspecified dates laboratory tests blood chemistry and complete blood count (CBC), electrocardiogram (EKG), Holter monitor, one month cardiac event monitor, and electroencephalogram (EEG) were performed and reported as normal. It was unspecified how long it took for the patient to recover from these fainting episodes, hyperhidrosis and hyperventilation and recovered in 2015. The action taken with GARDASIL was not reported. The outcome of heat intolerance, fatigue and exercise intolerance was reported as not recovered/not resolved. The causality was not reported. No further information provided. No product quality complaint (PQC) was filed. Additional information has been requested.
Age: 14.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Electrocardiogram normal, Electroencephalogram normal, Erythema, Exercise tolerance decreased, Eyelid ptosis
Clinical narrative: This spontaneous report was received from a physician and refers to a 14 year old male patient. No medical history and concurrent conditions were reported. On following dates 09-APR-2015, 02-DEC-2014 and 09-APR-2015, the patient was vaccinated with GARDASIL (lot # K006960 and expiry date: 14-JAN-2017), (lot: K006960; expiration: 19-FEB-2017) and (lot: K006960; expiration: 19-FEB-2017) respectively intramuscular injection. It was unspecified whether GARDASIL vials or pre-filled syringes were used for these doses. No concomitant medications were reported. On 18-APR-2015, the patient experienced heat intolerance, exercise intolerance and fatigue. The patient also had fainting episodes following exercise on 18-APR-2015, 15-MAY-2015 and on 15-JUN-2015. On 06-JUL-2015, the patient experienced diaphoresis and hyperventilation. On unspecified dates laboratory tests blood chemistry and complete blood count (CBC), electrocardiogram (EKG), Holter monitor, one month cardiac event monitor, and electroencephalogram (EEG) were performed and reported as normal. It was unspecified how long it took for the patient to recover from these fainting episodes, hyperhidrosis and hyperventilation and recovered in 2015. The action taken with GARDASIL was not reported. The outcome of heat intolerance, fatigue and exercise intolerance was reported as not recovered/not resolved. The causality was not reported. No further information provided. No product quality complaint (PQC) was filed. Additional information has been requested.
Age: 14.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Fatigue, Full blood count normal, Haematocrit normal, Haematology test normal, Haemoglobin normal
Clinical narrative: This spontaneous report was received from a physician and refers to a 14 year old male patient. No medical history and concurrent conditions were reported. On following dates 09-APR-2015, 02-DEC-2014 and 09-APR-2015, the patient was vaccinated with GARDASIL (lot # K006960 and expiry date: 14-JAN-2017), (lot: K006960; expiration: 19-FEB-2017) and (lot: K006960; expiration: 19-FEB-2017) respectively intramuscular injection. It was unspecified whether GARDASIL vials or pre-filled syringes were used for these doses. No concomitant medications were reported. On 18-APR-2015, the patient experienced heat intolerance, exercise intolerance and fatigue. The patient also had fainting episodes following exercise on 18-APR-2015, 15-MAY-2015 and on 15-JUN-2015. On 06-JUL-2015, the patient experienced diaphoresis and hyperventilation. On unspecified dates laboratory tests blood chemistry and complete blood count (CBC), electrocardiogram (EKG), Holter monitor, one month cardiac event monitor, and electroencephalogram (EEG) were performed and reported as normal. It was unspecified how long it took for the patient to recover from these fainting episodes, hyperhidrosis and hyperventilation and recovered in 2015. The action taken with GARDASIL was not reported. The outcome of heat intolerance, fatigue and exercise intolerance was reported as not recovered/not resolved. The causality was not reported. No further information provided. No product quality complaint (PQC) was filed. Additional information has been requested.
Age: 14.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Head injury, Headache, Hyperhidrosis, Hyperventilation, Hypoaesthesia
Clinical narrative: This spontaneous report was received from a physician and refers to a 14 year old male patient. No medical history and concurrent conditions were reported. On following dates 09-APR-2015, 02-DEC-2014 and 09-APR-2015, the patient was vaccinated with GARDASIL (lot # K006960 and expiry date: 14-JAN-2017), (lot: K006960; expiration: 19-FEB-2017) and (lot: K006960; expiration: 19-FEB-2017) respectively intramuscular injection. It was unspecified whether GARDASIL vials or pre-filled syringes were used for these doses. No concomitant medications were reported. On 18-APR-2015, the patient experienced heat intolerance, exercise intolerance and fatigue. The patient also had fainting episodes following exercise on 18-APR-2015, 15-MAY-2015 and on 15-JUN-2015. On 06-JUL-2015, the patient experienced diaphoresis and hyperventilation. On unspecified dates laboratory tests blood chemistry and complete blood count (CBC), electrocardiogram (EKG), Holter monitor, one month cardiac event monitor, and electroencephalogram (EEG) were performed and reported as normal. It was unspecified how long it took for the patient to recover from these fainting episodes, hyperhidrosis and hyperventilation and recovered in 2015. The action taken with GARDASIL was not reported. The outcome of heat intolerance, fatigue and exercise intolerance was reported as not recovered/not resolved. The causality was not reported. No further information provided. No product quality complaint (PQC) was filed. Additional information has been requested.
Age: 14.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Hypotension, Loss of consciousness, Lymphocyte percentage decreased, Memory impairment, Metabolic function test normal
Clinical narrative: This spontaneous report was received from a physician and refers to a 14 year old male patient. No medical history and concurrent conditions were reported. On following dates 09-APR-2015, 02-DEC-2014 and 09-APR-2015, the patient was vaccinated with GARDASIL (lot # K006960 and expiry date: 14-JAN-2017), (lot: K006960; expiration: 19-FEB-2017) and (lot: K006960; expiration: 19-FEB-2017) respectively intramuscular injection. It was unspecified whether GARDASIL vials or pre-filled syringes were used for these doses. No concomitant medications were reported. On 18-APR-2015, the patient experienced heat intolerance, exercise intolerance and fatigue. The patient also had fainting episodes following exercise on 18-APR-2015, 15-MAY-2015 and on 15-JUN-2015. On 06-JUL-2015, the patient experienced diaphoresis and hyperventilation. On unspecified dates laboratory tests blood chemistry and complete blood count (CBC), electrocardiogram (EKG), Holter monitor, one month cardiac event monitor, and electroencephalogram (EEG) were performed and reported as normal. It was unspecified how long it took for the patient to recover from these fainting episodes, hyperhidrosis and hyperventilation and recovered in 2015. The action taken with GARDASIL was not reported. The outcome of heat intolerance, fatigue and exercise intolerance was reported as not recovered/not resolved. The causality was not reported. No further information provided. No product quality complaint (PQC) was filed. Additional information has been requested.