chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 17.0
Sex: F
Vaccine: HPV9, MENB, MNQ
Symptoms: Dyspnoea, Erythema, Fatigue, Injection site erythema, Lymph node pain
Clinical narrative: 3 days after vaccines given pt was seen by PCP for complaints of arms hurting day after injections 6/8/16. Fever 100.5 felt very tired, pains in arms worse, could not lift (R) arm. Tender lump (L) clavicle. Red marks on arms near site of injections. Pt. c/o difficulty taking in breaths through throat. Symptoms persisted the following day, then somewhat better 3 day. Red marks persist. Area of redness not itching, not spreading. No other associated symptoms. Physician findings: tender to palpation above left clavicle with small palpable lymph nodes in supraclavicular area. Erythematous skin on bilateral upper arms that are tender to palpation, not warm or fluctuant, no hives/welts noted.
Age: 17.0
Sex: F
Vaccine: HPV9, MENB, MNQ
Symptoms: Mass, Mobility decreased, Pain in extremity, Pyrexia, Tenderness
Clinical narrative: 3 days after vaccines given pt was seen by PCP for complaints of arms hurting day after injections 6/8/16. Fever 100.5 felt very tired, pains in arms worse, could not lift (R) arm. Tender lump (L) clavicle. Red marks on arms near site of injections. Pt. c/o difficulty taking in breaths through throat. Symptoms persisted the following day, then somewhat better 3 day. Red marks persist. Area of redness not itching, not spreading. No other associated symptoms. Physician findings: tender to palpation above left clavicle with small palpable lymph nodes in supraclavicular area. Erythematous skin on bilateral upper arms that are tender to palpation, not warm or fluctuant, no hives/welts noted.
Age: 0.17
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC13
Symptoms: Fatigue, Pyrexia
Clinical narrative: Fever, tired.
Age: 1.71
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: 7X7 area of erythema, swelling Rt thigh around injection site.
Age: 1.83
Sex: F
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Injection site urticaria, Urticaria
Clinical narrative: Urticarial lesions to arms, legs, and back.
Age: 31.0
Sex: M
Vaccine: TDAP
Symptoms: Dizziness, Feeling hot
Clinical narrative: Within minutes of getting vaccine patient felt warm and lightheaded. We gave cold water and called 9-1-1. Paramedics evaluated patient and he stated he was better. He refused further care.
Age: 17.0
Sex: F
Vaccine: TYP, YF
Symptoms: Asthenia, Pain, Urticaria
Clinical narrative: Received Typhoid with Yellow Fever in left arm, within 24 hours hives appeared in armpit spreading to left side of trunk. Also experienced extreme weakness and aching "all over". Went to minor med and received steroid injection and dose pack. Symptoms slowly resolved after 72 hours.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Culture urine positive, Ear pain, Nausea, Pain
Clinical narrative: Administered ZOSTAVAX 6/6/16 - Returned to office  6/7/16 with c/o fever, chills, body aches, ear pain, nausea.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Streptococcus test negative
Clinical narrative: Administered ZOSTAVAX 6/6/16 - Returned to office  6/7/16 with c/o fever, chills, body aches, ear pain, nausea.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant concerning a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported. On an unknown date, the patient was vaccinated with a dose of improperly stored PEDVAXHIB (dose and route not reported, lot # L042257 and expiration date 17-AUG-2018). The vaccine was exposed to 25.7 F for 1 day, 21 hours and 41 minutes. No previous temperature was reported. No adverse effects were reported. 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 pharmacist, refers to an unknown number of patients of unknown age and gender. No pertinent medical history, drug reactions/allergies or concurrent conditions were reported. On an unknown date, the patients were vaccinated with doses of improperly stored ROTATEQ, orally (the lot #, expiration date and dosage number were not reported). Nonetheless, no adverse effects were reported. The vaccine experienced the following temperature excursions: 0.3C for 26 days and -11C for 5 days. Reportedly, there had been no previous temperature excursions and the aforementioned ones were identified due to a data logger. Furthermore, no product quality complaint was involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: RAB
Symptoms: Immediate post-injection reaction, Injury associated with device, Product quality issue, Puncture site haemorrhage
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of needle injury in a adult female patient who received RABAVERT (batch number 584011A, expiry date December 2018). This case was associated with a product complaint. On 23rd May 2016, the patient received RABAVERT. On 23rd May 2016, immediately after receiving RABAVERT, the patient experienced needle injury and puncture site hemorrhage. On an unknown date, the patient experienced pharmaceutical product complaint. On an unknown date, the outcome of the needle injury, puncture site hemorrhage and pharmaceutical product complaint were unknown. It was unknown if the reporter considered the needle injury and puncture site hemorrhage to be related to RABAVERT. Additional details were provided as follows: This case was previously reported to a manufacturer. The age at vaccination was not reported. The patient (medical assistant) successfully opened up the RABAVERT vaccine packaging, while attempting to take the cap off the needle (cap was hard to remove). The patient jammed herself in the finger and drew blood. The dose of RABAVERT vaccine was not administered to the one whom it should have been administered and GlaxoSmithKline was replacing to the pharmacy. The reporter did not know the date of birth of the patient.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist, refers to two patients of unknown age and gender. No pertinent medical history, drug reactions/allergies or concurrent conditions were reported. On an unknown date the patients were vaccinated with doses of improperly stored GARDASIL 9 (which had a lot # of L016429 and an expiration date of 09-AUG-2017; however, dosage number and route of administration were not reported). Nonetheless, no adverse effects were reported. The vaccine experienced the following temperature excursions: 0.3C for 26 days and -11C for 5 days. Reportedly, there had been no previous temperature excursions and the aforementioned ones were identified due to a data logger. Furthermore, no product quality complaint was involved. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to multiple unspecified patients of unknown ages and genders. The patients' concurrent conditions and medical history were not provided. On unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD injection, lot number M002053, expiration date 11-JUL-2017 (albumin status reported as rHA); M010475, expiration date 01-SEP-2017 (albumin status reported as HSA); L051102, expiration date 17-JUN-2017 (doses and routes were not reported). Concomitant therapies were not provided. According to the reporter, the vaccines were stored at a temperature of 10 degrees Fahrenheit for 40 days (960 hours). There was no previous temperature excursion reported. No adverse effect were reported. No product quality complain (PQC) was involved. This is one of two 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 registered nurse and refers to multiple unspecified patients of unknown ages and genders. The patients' concurrent conditions and medical history were not provided. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX injection, lot numbers L044525, expiration date 09-NOV-2017; M000756, expiration date 06-JAN-2018; L048466, expiration date 02-DEC-2017 (dose and route were not reported). Concomitant therapies were not provided. According to the reporter, the vaccines were stored at a temperature of 10 degrees Fahrenheit for 40 days (960 hours). There was no previous temperature excursion reported. No adverse effect were reported. No product quality complain (PQC) was involved. This is one of two reports received from the same reporter. Additional information has been requested.
Age: 47.0
Sex: M
Vaccine: PPV
Symptoms: Rash
Clinical narrative: Skin rash. Diphenhydramine 50 MG BID.
Age: 69.0
Sex: M
Vaccine: PNC
Symptoms: Erythema, Pruritus, Skin warm
Clinical narrative: Redness, warmth, and itchiness.
Age: 91.0
Sex: M
Vaccine: PNC
Symptoms: Injection site pain, Injection site rash
Clinical narrative: Rash and pain at injection site. Was seen by PA for symptoms and was treated with BACTRIM DS for 10 days.
Age: 79.0
Sex: F
Vaccine: PNC13
Symptoms: Headache, Musculoskeletal pain, Neck pain
Clinical narrative: Very bad pain on the side of the head down my neck and arm across the back of my head my neck and across my shoulder for about 2 weeks.
Age: 0.17
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC13, RV5
Symptoms: Accidental exposure to product, Diarrhoea, Irritability
Clinical narrative: This spontaneous report was received from a medical assistant, referring to a 8 week old female patient with gastroesophageal reflux disease. The patient had no pertinent medical history or drug reactions/allergies. On 31-MAY-2016 the patient was in the office for their "2 month checkup". When the healthcare worker placed the open vial of ROTATEQ (lot # M004890, 10-NOV-2017, strength and dose were not provided) to the patient's mouth for administration "a trace amount of ROTATEQ may have gotten on the patient's lip prior to the patient's mother declining the vaccine"). Concomitant therapies included IPOL, PREVNAR 13, ZANTAC, DAPTACEL and ACTHIB. The patient's mother called to the office and reported that since 03-JUN-2016, the patient was "fussy" (irritability). The patient's mother called to the office again and on 06-JUN-2016 and reported that since an unspecified date in June 2016, the patient had looser stools than normal, and was still fussy. There were no laboratory diagnostics studies performed. At the time of reporting, the patient was not recovered from the events. Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: MMR
Symptoms: Feeling hot, Pruritus, Rash
Clinical narrative: Rash/feeling hot, itchy. BENADRYL 25 mg.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Cough, Dyspnoea, Erythema, Rash, Wheezing
Clinical narrative: Approximately 10 minutes after immunizations pt RTC with SOB, coughing, red face. Examined by physician - RR 22, faint expiratory wheeze, HR 90, no retractions, no grunting. Red rash to face - Dad was instructed to go directly to ER.
Age: 1.25
Sex: M
Vaccine: DTAPHEPBIP, HIBV, VARCEL
Symptoms: Rash
Clinical narrative: Rash day after vaccines-Varicella was only new vaccine.
Age: 17.0
Sex: F
Vaccine: HEPA
Symptoms: Computerised tomogram head normal, Electroencephalogram normal, Urinary incontinence, Vomiting
Clinical narrative: The morning after receiving her first Hepatitis A vaccine she awoke having urinated during her sleep with some apparent vomitus on sheet. She has never had enuresis. She seemed fine before going to sleep and after waking.
Age: 14.0
Sex: F
Vaccine: HEPA, HPV9
Symptoms: Dizziness, Nausea
Clinical narrative: Arrived with mother for HPV #2 as ordered (nurse only visit) gave orange juice before shot as did not eat breakfast - but had 'early lunch' at 12:00. (1440) HPV #2 given Lt deltoid and Hep A #1. (1445) Patient states felt nauseous and laid head back in chair closed eyes. This RN observed head movement and went to room to ask patient how she feels. Stated nauseous, dizzy, responded appropriately. See BP's done. Orange juice given again, cold cloth, chair to supine, did not lose consciousness or vomit. Observed for extended period of 70 minutes with vitals assessed. Discharged with mom - stable.
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Injection site discomfort, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Swelling, increase at injection site, warmth, redness, pain, headache. Received on 5/26/16. Discomfort at injection site on Sun and increasing. Exam: swollen, indurated, erythema 3cm (L) deltoid at 8 days post vaccination.
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site swelling, Injection site warmth, Laboratory test
Clinical narrative: Swelling, increase at injection site, warmth, redness, pain, headache. Received on 5/26/16. Discomfort at injection site on Sun and increasing. Exam: swollen, indurated, erythema 3cm (L) deltoid at 8 days post vaccination.
Age: 1.01
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Fatigue, Injection site erythema, Pyrexia, Rash erythematous, Rash maculo-papular
Clinical narrative: Low grade fever for 4 days w/fine red maculopapular rash. Local erythema at injection site MMR. Then 1 week after vaccine episode of emesis w/fatigue, last less than 24 hr.
Age: 1.01
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Vomiting
Clinical narrative: Low grade fever for 4 days w/fine red maculopapular rash. Local erythema at injection site MMR. Then 1 week after vaccine episode of emesis w/fatigue, last less than 24 hr.
Age: 55.0
Sex: M
Vaccine: TDAP
Symptoms: Asthenia, Dyspnoea, Fatigue, Muscle spasms, Musculoskeletal stiffness
Clinical narrative: Patient states he developed painful muscle contractions/spasms, stiffness, fatigue/decreased energy the morning after vaccine admin. Also reported productive cough, shortness of breath. Most symptoms resolved after 3 to 7 days. Slight cough continued.
Age: 55.0
Sex: M
Vaccine: TDAP
Symptoms: Pain, Productive cough
Clinical narrative: Patient states he developed painful muscle contractions/spasms, stiffness, fatigue/decreased energy the morning after vaccine admin. Also reported productive cough, shortness of breath. Most symptoms resolved after 3 to 7 days. Slight cough continued.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Skin infection
Clinical narrative: Red area 4x3 at site of injection and painful-infection at site.
Age: 62.0
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site swelling
Clinical narrative: Approx 30 hours after ZOSTAVAX injection pt experienced swelling and extreme itching around injection site enveloping almost completely around upper left arm continuing to swell for up to 48 hrs then beginning to subside at 96 hrs at which pt returned to normal. No permanent issue appears to have occurred.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Red, swollen at injection site. Hot to touch for 12 hours. Used ice pack.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Haematoma, Head injury
Clinical narrative: Patient felt dizzy and fell to the ground few minutes after while standing. Hit head left-side of occiput. Recovered quickly. Examined - small hematoma scalp.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Skin discolouration, Skin warm, Tenderness
Clinical narrative: 3" red circle raised, ice pack within 24 hrs 4/30.  3" spot hard an dark red spreading down arm, tender and warm 5/1. Redness spreading down elbow 5/2. Urgent care antibiotic and steroid 5/2.
Age: 1.01
Sex: M
Vaccine: HEPA, HIBV, PNC13
Symptoms: Injection site erythema
Clinical narrative: PREVNAR injection site with linear horizontal erythema 4 cm long.
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Immediate post-injection reaction, Injection site erythema, Pain, Swelling, Swelling face
Clinical narrative: Immediate erythema surrounding varicella injection site (appropriately 4" in diameter). (+) painful, swollen area marked-BENEDRYL given and iced region with some improvement in office. Child observed for 30 mins. Mom called about 2 hours later with concern of facial swelling, no resp sx's and swelling self resolved.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Erythema, Induration, Skin warm
Clinical narrative: Quarter size red area 24 hours after injection. One day later, redness increase to triple size, warm and firm to touch. (6.75 x 5 cm).
Age: 63.0
Sex: M
Vaccine: PNC13
Symptoms: Immediate post-injection reaction, Injection site swelling, Paraesthesia
Clinical narrative: Local rxn (swelling) at injection site immediately. Within 5 min pt noticed tingling sensation through chest area and other arm.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Dizziness, Eye movement disorder, Nausea, Postictal state
Clinical narrative: HPV vaccine and MENACTRA vaccine administered to patient. Patient felt faint and nausea approximately one minute s/p vaccine administration. Two RN's witnessed eyes rolling back in and head and patient was postictal.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: Pt has redness, rash and swelling at injection sites.
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Redness to upper right arm and itchy.
Age: 0.34
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: 2 1/2 cm of redness, induration and warmth on right thigh.
Age: 1.53
Sex: F
Vaccine: VARCEL
Symptoms: Decreased appetite, Diarrhoea, Laboratory test normal, Pain, Pallor
Clinical narrative: (1) Maculopapular blanching rash - 1 wk after vaccine mainly unilateral (Right side of body). (2) Fever. (3) Body ache loss of appetite. (4) vomiting/diarrhea.
Age: 1.53
Sex: F
Vaccine: VARCEL
Symptoms: Pyrexia, Rash maculo-papular, Vomiting
Clinical narrative: (1) Maculopapular blanching rash - 1 wk after vaccine mainly unilateral (Right side of body). (2) Fever. (3) Body ache loss of appetite. (4) vomiting/diarrhea.
Age: 79.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Injection site reaction, itching, swelling, and redness. ALLEGRA 180 mg daily, PEPCID AC 20 mg twice daily, BENADRYL 25 mg 2 tabs at bedtime for itching. Hydrocortisone cream 1% twice daily.
Age: 88.0
Sex: M
Vaccine: PPV
Symptoms: Feeling cold, Vomiting
Clinical narrative: Immunization administered 9:55 am. Received call from patient's wife 1:45pm reporting chills. Another call around 4:00pm reporting vomiting. I called to check on patient at 7:30pm. patient's wife stated symptoms improved, no more vomiting occurred. She feels he is better.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site mass, Injection site pain
Clinical narrative: PREVNAR 13 was given on 06/08/16. Pt called the office on 06/14/16 stating arm was still quite sore from injection and pain into axilla. Had a lump at injection site. No redness or signs of infection.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Generalised tonic-clonic seizure, Loss of consciousness, Postictal state
Clinical narrative: Seizure - grand mal with loss of consciousness and postictal sleep. (2-3 minutes seizure, postictal -15 min). No neurological complications. Meds: VALIUM 5 mg po - q 12 H then, 1 - q 30 hrs then, 1 - q 48 hrs then, 1 - q 72 hrs, 5 tab total.
Sex: M
Vaccine: MMRV
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: Started showing redness and a little swelling noted 5/4/16 around noon. Was itching after shot was administered as per mom. Able to have full mobility of (L) upper arm.
Age: 18.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2012US016143, is an initial spontaneous report received from a pharmacist on 13 Aug 2012. This report refers to an 18-year-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with MENVEO (batch number: X10061), intramuscularly on 11 Aug 2012. The pharmacist reported that the patient received only the Men C, Y, W-1035 liquid conjugate (solvent) was administered without dissolving the men A lyophilized component (powder). No adverse event was reported.
Age: 11.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Case number PHEH2012US018211 is an initial spontaneous report received from a nurse on 14 Sep 2012 and a follow up received from a healthcare professional on 08 Oct 2012. This case refers to an 11-year-old male patient. He was vaccinated with MENVEO (batch number: A11082) intramuscularly on 30 Aug 2012. About five hours after vaccination he experienced swelling and redness at the injection site with (14x4 cm) induration. He was treated with MEDROL dosepak 4mg and the events resolved on unspecified date. No other information was available. Follow up information received from a healthcare professional on 08 Oct 2012: Added additional event of injection site induration, update patient initials, height and weight.
Age: 27.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Case number PHEH2012US024866 is an initial spontaneous report received from a consumer on 17 Dec 2012: This report refers to a 27-year-old female patient. She was vaccinated with MENVEO (batch number: unknown) subcutaneously above the back of her elbow on 13 Dec 2012. Later on that day she began to experience a raised, reddened and itchy area at the injection site. The outcome was reported as condition unchanged. No further information was available.
Age: 18.0
Sex: F
Vaccine: MEN, VARCEL, MNQ
Symptoms: Exposure during pregnancy, Pregnancy test positive, Tuberculin test
Clinical narrative: Case number PHEH2012US019489 is an initial spontaneous report received from a nurse on 28 Sep 2012 with a follow up information on 28 Sep 2012, and with a follow up received on 12 Nov 2012. This case refers to an 18-year-old pregnant female patient. Date of last menstrual period was 01 Aug 2012. The patient had no medical problem. This pregnant patient was inadvertently vaccinated with MENVEO vaccine (batch number: A11051, expiry date: Apr 2013) intramuscularly on 13 Sep 2012. No adverse event was reported since vaccination. No other information was available. Follow up information received on 28 Sep 2012: Expiry date of vaccine updated. Follow up report received on 12 Nov 2012. Updated patient demographics. LMP date.
Age: 18.0
Sex: F
Vaccine: MEN, VARCEL, MNQ
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Case number PHEH2012US019489 is an initial spontaneous report received from a nurse on 28 Sep 2012 with a follow up information on 28 Sep 2012, and with a follow up received on 12 Nov 2012. This case refers to an 18-year-old pregnant female patient. Date of last menstrual period was 01 Aug 2012. The patient had no medical problem. This pregnant patient was inadvertently vaccinated with MENVEO vaccine (batch number: A11051, expiry date: Apr 2013) intramuscularly on 13 Sep 2012. No adverse event was reported since vaccination. No other information was available. Follow up information received on 28 Sep 2012: Expiry date of vaccine updated. Follow up report received on 12 Nov 2012. Updated patient demographics. LMP date.
Age: 11.0
Sex: F
Vaccine: MEN, MNQ
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Case number PHEH2012US021418 is an initial spontaneous report received from a nurse on 22 Oct 2012. This case refers to an 11-year-old female patient. She was vaccinated with the first dose of MENVEO (batch number: not reported) on 21 Jun 2007. Second dose was inadvertently administered on 20 Nov 2007. No adverse event was reported following vaccination.
Age: 11.0
Sex: F
Vaccine: MEN, MNQ
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Case number PHEH2012US021418 is an initial spontaneous report received from a nurse on 22 Oct 2012. This case refers to an 11-year-old female patient. She was vaccinated with the first dose of MENVEO (batch number: not reported) on 21 Jun 2007. Second dose was inadvertently administered on 20 Nov 2007. No adverse event was reported following vaccination.
Age: 24.0
Sex: F
Vaccine: MNQ
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Case number PHEH2012US018900 is an initial spontaneous report received from a medical assistant on 18 Sep 2012: This report refers to a 24-year-old female patient. She was vaccinated with MENVEO (batch number: unknown) intramuscularly in the previous week before the date of reporting. On 18 Sep 2012 she notified the facility that she was 15-weeks pregnant. No adverse event was reported since administration of the vaccine.
Sex: U
Vaccine: VARZOS
Symptoms: Ophthalmic herpes zoster, Uveitis
Clinical narrative: Information has been received from a physician via a company representative referring to unspecified number of patients of unknown age and gender. The physician reported that he read in the following medical journals: that there had been cases. The cases were reported as on unknown dates the patients were vaccinated with ZOSTAVAX (strength, dose, route, lot# and expiration date not provided). No concomitant medication reported. It was reported that some patients had pre-existing autoimmune disorder; in some cases, the zoster keratitis and uveitis developed one or two weeks after receiving ZOSTAVAX. At the time of reporting, the outcome of adverse events was unknown. The causality between adverse events and ZOSTAVAX was not provided. Additional information is not expected as the reporter did not wish further contact. Upon internal review, zoster keratitis and uveitis were determined to be medically significant. It has been determined that case # US-009507513-1507USA003806 is a duplicate of case # US-0095074513-1507USA003784. Therefore, case # US-009507513-1507USA003806 is being deleted from our files and the cases are consolidated into case # US-009507513-1507USA003784.
Sex: U
Vaccine: VARZOS
Symptoms: Ophthalmic herpes zoster, Uveitis
Clinical narrative: Information has been received from a physician via a company representative referring to unspecified patients of unknown age and gender. The physician reported that he read in the following medical journals: that there had been cases. The cases were reported as the patients were vaccinated with ZOSTAVAX (strength, dose, route, lot# and expiration date not provided) on unknown dates. No concomitant medication reported. It was reported that some patients had pre-existing autoimmune disorder; in some cases, the zoster keratitis and uveitis developed one or two weeks after receiving ZOSTAVAX. At the time of reporting, the outcome of adverse events was unknown. The causality between adverse events and ZOSTAVAX was not provided. Additional information is not expected as the reporter did not wish further contact. Upon internal review, zoster keratitis and uveitis were determined to be medically significant. It has been determined that case # US-009507513-1507USA003806 is a duplicate of case # US-009507513-1507USA003784. Therefore, case # US-009507513-1507USA003806 is being deleted from out files and the cases are consolidated into case # US-009507513-1507USA003784.
Age: 16.0
Sex: M
Vaccine: HPV9, MENB, MNQ, HPV9, MENB, MNQ, HPV9, MENB, MNQ, HPV4, MENB, MNQ
Symptoms: Asthenia, Computerised tomogram head normal, Condition aggravated, Decreased appetite, Drug screen negative
Clinical narrative: Initial unsolicited report received from a nurse on 31 May 2016. This case involves a male patient (age not reported) who was vaccinated with a dose of MENACTRA (batch number, expiration date, site and route of administration were not reported), a dose of TRUMENBA and a dose of GARDASIL (manufacturer: other, batch number, expiration date, site and route of administration were not reported for both vaccines) all on 20 April 2016. The patient's medical history and concomitant medications were not reported. On an unspecified date, the next day (reported as 24 hours following the vaccination), the patient attended football practice and experienced dizziness, shortness of breath and ultimately fainted. On an unspecified date, patient was admitted to the hospital for one day for observation and then released. The patient was then seen by physician, the day after been released from the hospital. Lab data and corrective treatment were not reported. Outcome of the events was not reported. List of documents held by sender: none. Sender's Comments: A male patient experienced shortness of breath, dizziness and fainted (while football practice) 24 hours after simultaneous vaccination with MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE, MENINGOCOCCAL VACCINE and HUMAN PAPILLOMA VIRUS VACCINE. All the events are listed for MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE. The time of onset is compatible with the role of vaccine. Patient medical history, trauma history during football practice, history of any respiratory illness are needed for complete assessment of the case. Patient received 3 vaccines concomitantly, hence the role of single vaccine cannot be assessed.
Age: 16.0
Sex: M
Vaccine: HPV9, MENB, MNQ, HPV9, MENB, MNQ, HPV9, MENB, MNQ, HPV4, MENB, MNQ
Symptoms: Dyspnoea, Flushing, Full blood count normal, Gait disturbance, Injection site pain
Clinical narrative: Initial unsolicited report received from a nurse on 31 May 2016. This case involves a male patient (age not reported) who was vaccinated with a dose of MENACTRA (batch number, expiration date, site and route of administration were not reported), a dose of TRUMENBA and a dose of GARDASIL (manufacturer: other, batch number, expiration date, site and route of administration were not reported for both vaccines) all on 20 April 2016. The patient's medical history and concomitant medications were not reported. On an unspecified date, the next day (reported as 24 hours following the vaccination), the patient attended football practice and experienced dizziness, shortness of breath and ultimately fainted. On an unspecified date, patient was admitted to the hospital for one day for observation and then released. The patient was then seen by physician, the day after been released from the hospital. Lab data and corrective treatment were not reported. Outcome of the events was not reported. List of documents held by sender: none. Sender's Comments: A male patient experienced shortness of breath, dizziness and fainted (while football practice) 24 hours after simultaneous vaccination with MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE, MENINGOCOCCAL VACCINE and HUMAN PAPILLOMA VIRUS VACCINE. All the events are listed for MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE. The time of onset is compatible with the role of vaccine. Patient medical history, trauma history during football practice, history of any respiratory illness are needed for complete assessment of the case. Patient received 3 vaccines concomitantly, hence the role of single vaccine cannot be assessed.
Age: 16.0
Sex: M
Vaccine: HPV9, MENB, MNQ, HPV9, MENB, MNQ, HPV9, MENB, MNQ, HPV4, MENB, MNQ
Symptoms: Malaise, Metabolic function test normal, Migraine, Pharyngeal oedema, Rash
Clinical narrative: Initial unsolicited report received from a nurse on 31 May 2016. This case involves a male patient (age not reported) who was vaccinated with a dose of MENACTRA (batch number, expiration date, site and route of administration were not reported), a dose of TRUMENBA and a dose of GARDASIL (manufacturer: other, batch number, expiration date, site and route of administration were not reported for both vaccines) all on 20 April 2016. The patient's medical history and concomitant medications were not reported. On an unspecified date, the next day (reported as 24 hours following the vaccination), the patient attended football practice and experienced dizziness, shortness of breath and ultimately fainted. On an unspecified date, patient was admitted to the hospital for one day for observation and then released. The patient was then seen by physician, the day after been released from the hospital. Lab data and corrective treatment were not reported. Outcome of the events was not reported. List of documents held by sender: none. Sender's Comments: A male patient experienced shortness of breath, dizziness and fainted (while football practice) 24 hours after simultaneous vaccination with MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE, MENINGOCOCCAL VACCINE and HUMAN PAPILLOMA VIRUS VACCINE. All the events are listed for MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE. The time of onset is compatible with the role of vaccine. Patient medical history, trauma history during football practice, history of any respiratory illness are needed for complete assessment of the case. Patient received 3 vaccines concomitantly, hence the role of single vaccine cannot be assessed.
Age: 16.0
Sex: M
Vaccine: HPV9, MENB, MNQ, HPV9, MENB, MNQ, HPV9, MENB, MNQ, HPV4, MENB, MNQ
Symptoms: Syncope
Clinical narrative: Initial unsolicited report received from a nurse on 31 May 2016. This case involves a male patient (age not reported) who was vaccinated with a dose of MENACTRA (batch number, expiration date, site and route of administration were not reported), a dose of TRUMENBA and a dose of GARDASIL (manufacturer: other, batch number, expiration date, site and route of administration were not reported for both vaccines) all on 20 April 2016. The patient's medical history and concomitant medications were not reported. On an unspecified date, the next day (reported as 24 hours following the vaccination), the patient attended football practice and experienced dizziness, shortness of breath and ultimately fainted. On an unspecified date, patient was admitted to the hospital for one day for observation and then released. The patient was then seen by physician, the day after been released from the hospital. Lab data and corrective treatment were not reported. Outcome of the events was not reported. List of documents held by sender: none. Sender's Comments: A male patient experienced shortness of breath, dizziness and fainted (while football practice) 24 hours after simultaneous vaccination with MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE, MENINGOCOCCAL VACCINE and HUMAN PAPILLOMA VIRUS VACCINE. All the events are listed for MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE. The time of onset is compatible with the role of vaccine. Patient medical history, trauma history during football practice, history of any respiratory illness are needed for complete assessment of the case. Patient received 3 vaccines concomitantly, hence the role of single vaccine cannot be assessed.
Age: 16.0
Sex: M
Vaccine: HPV9, MENB, MNQ, HPV9, MENB, MNQ, HPV9, MENB, MNQ, HPV4, MENB, MNQ
Symptoms: Asthenia, Computerised tomogram, Drug screen, Dyspnoea, Flushing
Clinical narrative: Initial unsolicited report received from a nurse on 31 May 2016. This case involves a male patient (age not reported) who was vaccinated with a dose of MENACTRA (batch number, expiration date, site and route of administration were not reported), a dose of TRUMENBA and a dose of GARDASIL (manufacturer: other, batch number, expiration date, site and route of administration were not reported for both vaccines) all on 20 April 2016. The patient's medical history and concomitant medications were not reported. On an unspecified date, the next day (reported as 24 hours following the vaccination), the patient attended football practice and experienced dizziness, shortness of breath and ultimately fainted. On an unspecified date, patient was admitted to the hospital for one day for observation and then released. The patient was then seen by physician, the day after been released from the hospital. Lab data and corrective treatment were not reported. Outcome of the events was not reported. List of documents held by sender: none. Sender's Comments: A male patient experienced shortness of breath, dizziness and fainted (while football practice) 24 hours after simultaneous vaccination with MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE, MENINGOCOCCAL VACCINE and HUMAN PAPILLOMA VIRUS VACCINE. All the events are listed for MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE. The time of onset is compatible with the role of vaccine. Patient medical history, trauma history during football practice, history of any respiratory illness are needed for complete assessment of the case. Patient received 3 vaccines concomitantly, hence the role of single vaccine cannot be assessed.
Age: 16.0
Sex: M
Vaccine: HPV9, MENB, MNQ, HPV9, MENB, MNQ, HPV9, MENB, MNQ, HPV4, MENB, MNQ
Symptoms: Injection site pain, Migraine
Clinical narrative: Initial unsolicited report received from a nurse on 31 May 2016. This case involves a male patient (age not reported) who was vaccinated with a dose of MENACTRA (batch number, expiration date, site and route of administration were not reported), a dose of TRUMENBA and a dose of GARDASIL (manufacturer: other, batch number, expiration date, site and route of administration were not reported for both vaccines) all on 20 April 2016. The patient's medical history and concomitant medications were not reported. On an unspecified date, the next day (reported as 24 hours following the vaccination), the patient attended football practice and experienced dizziness, shortness of breath and ultimately fainted. On an unspecified date, patient was admitted to the hospital for one day for observation and then released. The patient was then seen by physician, the day after been released from the hospital. Lab data and corrective treatment were not reported. Outcome of the events was not reported. List of documents held by sender: none. Sender's Comments: A male patient experienced shortness of breath, dizziness and fainted (while football practice) 24 hours after simultaneous vaccination with MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE, MENINGOCOCCAL VACCINE and HUMAN PAPILLOMA VIRUS VACCINE. All the events are listed for MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE. The time of onset is compatible with the role of vaccine. Patient medical history, trauma history during football practice, history of any respiratory illness are needed for complete assessment of the case. Patient received 3 vaccines concomitantly, hence the role of single vaccine cannot be assessed.
Age: 16.0
Sex: M
Vaccine: HPV9, MENB, MNQ, HPV9, MENB, MNQ, HPV9, MENB, MNQ, HPV4, MENB, MNQ
Symptoms: Abasia, Asthenia, Computerised tomogram normal, Drug screen negative, Dyspnoea
Clinical narrative: Initial unsolicited report received from a nurse on 31 May 2016. This case involves a male patient (age not reported) who was vaccinated with a dose of MENACTRA (batch number, expiration date, site and route of administration were not reported), a dose of TRUMENBA and a dose of GARDASIL (manufacturer: other, batch number, expiration date, site and route of administration were not reported for both vaccines) all on 20 April 2016. The patient's medical history and concomitant medications were not reported. On an unspecified date, the next day (reported as 24 hours following the vaccination), the patient attended football practice and experienced dizziness, shortness of breath and ultimately fainted. On an unspecified date, patient was admitted to the hospital for one day for observation and then released. The patient was then seen by physician, the day after been released from the hospital. Lab data and corrective treatment were not reported. Outcome of the events was not reported. List of documents held by sender: none. Sender's Comments: A male patient experienced shortness of breath, dizziness and fainted (while football practice) 24 hours after simultaneous vaccination with MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE, MENINGOCOCCAL VACCINE and HUMAN PAPILLOMA VIRUS VACCINE. All the events are listed for MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE. The time of onset is compatible with the role of vaccine. Patient medical history, trauma history during football practice, history of any respiratory illness are needed for complete assessment of the case. Patient received 3 vaccines concomitantly, hence the role of single vaccine cannot be assessed.
Age: 16.0
Sex: M
Vaccine: HPV9, MENB, MNQ, HPV9, MENB, MNQ, HPV9, MENB, MNQ, HPV4, MENB, MNQ
Symptoms: Eating disorder, Flushing, Full blood count normal, Injection site pain, Malaise
Clinical narrative: Initial unsolicited report received from a nurse on 31 May 2016. This case involves a male patient (age not reported) who was vaccinated with a dose of MENACTRA (batch number, expiration date, site and route of administration were not reported), a dose of TRUMENBA and a dose of GARDASIL (manufacturer: other, batch number, expiration date, site and route of administration were not reported for both vaccines) all on 20 April 2016. The patient's medical history and concomitant medications were not reported. On an unspecified date, the next day (reported as 24 hours following the vaccination), the patient attended football practice and experienced dizziness, shortness of breath and ultimately fainted. On an unspecified date, patient was admitted to the hospital for one day for observation and then released. The patient was then seen by physician, the day after been released from the hospital. Lab data and corrective treatment were not reported. Outcome of the events was not reported. List of documents held by sender: none. Sender's Comments: A male patient experienced shortness of breath, dizziness and fainted (while football practice) 24 hours after simultaneous vaccination with MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE, MENINGOCOCCAL VACCINE and HUMAN PAPILLOMA VIRUS VACCINE. All the events are listed for MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE. The time of onset is compatible with the role of vaccine. Patient medical history, trauma history during football practice, history of any respiratory illness are needed for complete assessment of the case. Patient received 3 vaccines concomitantly, hence the role of single vaccine cannot be assessed.
Age: 16.0
Sex: M
Vaccine: HPV9, MENB, MNQ, HPV9, MENB, MNQ, HPV9, MENB, MNQ, HPV4, MENB, MNQ
Symptoms: Metabolic function test normal, Migraine, Neurological examination normal, Pharyngeal oedema, Rash
Clinical narrative: Initial unsolicited report received from a nurse on 31 May 2016. This case involves a male patient (age not reported) who was vaccinated with a dose of MENACTRA (batch number, expiration date, site and route of administration were not reported), a dose of TRUMENBA and a dose of GARDASIL (manufacturer: other, batch number, expiration date, site and route of administration were not reported for both vaccines) all on 20 April 2016. The patient's medical history and concomitant medications were not reported. On an unspecified date, the next day (reported as 24 hours following the vaccination), the patient attended football practice and experienced dizziness, shortness of breath and ultimately fainted. On an unspecified date, patient was admitted to the hospital for one day for observation and then released. The patient was then seen by physician, the day after been released from the hospital. Lab data and corrective treatment were not reported. Outcome of the events was not reported. List of documents held by sender: none. Sender's Comments: A male patient experienced shortness of breath, dizziness and fainted (while football practice) 24 hours after simultaneous vaccination with MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE, MENINGOCOCCAL VACCINE and HUMAN PAPILLOMA VIRUS VACCINE. All the events are listed for MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE. The time of onset is compatible with the role of vaccine. Patient medical history, trauma history during football practice, history of any respiratory illness are needed for complete assessment of the case. Patient received 3 vaccines concomitantly, hence the role of single vaccine cannot be assessed.
Age: 16.0
Sex: M
Vaccine: HPV9, MENB, MNQ, HPV9, MENB, MNQ, HPV9, MENB, MNQ, HPV4, MENB, MNQ
Symptoms: Dizziness, Dyspnoea, Syncope
Clinical narrative: Initial unsolicited report received from a nurse on 31 May 2016. This case involves a male patient (age not reported) who was vaccinated with a dose of MENACTRA (batch number, expiration date, site and route of administration were not reported), a dose of TRUMENBA and a dose of GARDASIL (manufacturer: other, batch number, expiration date, site and route of administration were not reported for both vaccines) all on 20 April 2016. The patient's medical history and concomitant medications were not reported. On an unspecified date, the next day (reported as 24 hours following the vaccination), the patient attended football practice and experienced dizziness, shortness of breath and ultimately fainted. On an unspecified date, patient was admitted to the hospital for one day for observation and then released. The patient was then seen by physician, the day after been released from the hospital. Lab data and corrective treatment were not reported. Outcome of the events was not reported. List of documents held by sender: none. Sender's Comments: A male patient experienced shortness of breath, dizziness and fainted (while football practice) 24 hours after simultaneous vaccination with MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE, MENINGOCOCCAL VACCINE and HUMAN PAPILLOMA VIRUS VACCINE. All the events are listed for MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE. The time of onset is compatible with the role of vaccine. Patient medical history, trauma history during football practice, history of any respiratory illness are needed for complete assessment of the case. Patient received 3 vaccines concomitantly, hence the role of single vaccine cannot be assessed.
Age: 13.0
Sex: M
Vaccine: MMR
Symptoms: Cough, Fatigue, Headache, Myalgia, Oropharyngeal pain
Clinical narrative: 103.5 fever, fatigue, headache, muscle soreness & pain, Cough, sore throat.
Age: 13.0
Sex: M
Vaccine: MMR
Symptoms: Pyrexia
Clinical narrative: 103.5 fever, fatigue, headache, muscle soreness & pain, Cough, sore throat.
Age: 68.0
Sex: F
Vaccine: HEP
Symptoms: Blood test, Lymphadenopathy, Mass, Upper extremity mass, X-ray abnormal
Clinical narrative: Swollen neck lymph node lump in arm and groins.
Age: 24.0
Sex: F
Vaccine: HPV4, PNC13
Symptoms: Injected limb mobility decreased, Injection site joint pain
Clinical narrative: Extreme pain in shoulder joint of vaccinated arm.unable to move joint.