chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 12.0
Sex: F
Vaccine: FLUN3, HEPA, HPVX, MEN
Symptoms: Abdominal pain, Cough, Decreased appetite, Dizziness, Headache
Clinical narrative: Abdominal pain, headache, congestion, cough, runny nose dizziness, loss of appetite, ringing in the ears etc. Problems have continued with only two weeks relief at times.
Age: 12.0
Sex: F
Vaccine: FLUN3, HEPA, HPVX, MEN
Symptoms: Respiratory tract congestion, Rhinorrhoea, Tinnitus
Clinical narrative: Abdominal pain, headache, congestion, cough, runny nose dizziness, loss of appetite, ringing in the ears etc. Problems have continued with only two weeks relief at times.
Age: 12.0
Sex: F
Vaccine: HPV2, MNQ, TDAP
Symptoms: Dizziness
Clinical narrative: Dizziness.
Age: 12.0
Sex: F
Vaccine: HPV2, MNQ, TDAP
Symptoms: Dizziness
Clinical narrative: Dizziness /given ammonia.
Age: 55.0
Sex: M
Vaccine: HEPAB, PPV
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Injection site warmth, Oedema
Clinical narrative: Reaction was to Pneumo vaccine: Severe LUE pain, erythema and edema to much larger area than injection site, warm to touch. Patient was seen by MD and given Amoxicillin and Bactrim.
Age: 52.0
Sex: M
Vaccine: PNC13
Symptoms: Chills, Fatigue, Headache, Hyperhidrosis, Injection site erythema
Clinical narrative: Day 1: redness at injection site. Day 2: awoke with bad headache, fatigue, aches. Took 400 Motrin po. That evening, had chills, sweating. Day 3: night chills and sweating again. Day 5: noticed large red patches (non-tender, non-pruritic) on upper left arm. Day 6: came to clinic. Patches measure 14cm x 10 cm,and 10cm x 7 cm on upper left arm. No adenopathy.
Age: 52.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site reaction, Pain, Rash erythematous
Clinical narrative: Day 1: redness at injection site. Day 2: awoke with bad headache, fatigue, aches. Took 400 Motrin po. That evening, had chills, sweating. Day 3: night chills and sweating again. Day 5: noticed large red patches (non-tender, non-pruritic) on upper left arm. Day 6: came to clinic. Patches measure 14cm x 10 cm,and 10cm x 7 cm on upper left arm. No adenopathy.
Age: 18.0
Sex: M
Vaccine: HPV4
Symptoms: Hallucination, visual, Headache, Hearing impaired, Hypoaesthesia, Visual impairment
Clinical narrative: Numbness on the right hand in the thumb joint area, vision disturbances, headache, seeing things that were not there, hearing sounds but perceiving that they were comming from directions that were different from where they were actually originating from.
Age: 51.0
Sex: M
Vaccine: PNC13, PPV
Symptoms: Alanine aminotransferase increased, Arthralgia, Aspartate aminotransferase increased, Injection site inflammation, Myalgia
Clinical narrative: Fever to 102, site inflammation, myalgias, arthralgias.
Age: 51.0
Sex: M
Vaccine: PNC13, PPV
Symptoms: Pyrexia
Clinical narrative: Fever to 102, site inflammation, myalgias, arthralgias.
Age: 52.0
Sex: F
Vaccine: DTAP
Symptoms: Arthralgia, Asthenia, Myalgia, Pyrexia, Urinary tract infection
Clinical narrative: Joint and muscle aches, fever, weakness; turned out to have urinary tract infection, was also treated with anti-inflammatory medication.
Age: 5.0
Sex: F
Vaccine: DTAP, MMRV
Symptoms: Altered state of consciousness, Cerebral microhaemorrhage, Herpes simplex, Meningoencephalitis herpetic, Nuclear magnetic resonance imaging brain abnormal
Clinical narrative: Altered level of consciousness.
Age: 5.0
Sex: F
Vaccine: DTAP, MMRV
Symptoms: White matter lesion
Clinical narrative: Altered level of consciousness.
Age: 17.0
Sex: F
Vaccine: FLU3, VARCEL
Symptoms: Blood glucose normal, Dizziness, Malaise, Nausea
Clinical narrative: Client received varicella, influenza and TB skin test. She stated "I don't feel well, like I'm going to throw up." She then stated "I feel lightheaded." Client was assisted to the ground with her feet elevated. Blood pressure 90/50, blood sugar 103. Client was given Pepsi and peanut butter crackers. She stated she only had a Pop Tart to eat that day.
Age: 30.0
Sex: F
Vaccine: TD
Symptoms: Ear infection
Clinical narrative: Pt's mother called 5/29/13 stated that her daughter was having jaw pain and received Td vaccine the wk before. He went to a clinic and was diagnosed with an ear infection and started on amoxicillin on Monday evening 5/27/13. Mother stated the pain is probably caused by ear infection. I instructed on CDC guidelines, side effects, of Td vaccine. She stated she understood. Instructed to follow up with physician if this did not improve.
Age: 45.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Dyspnoea, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Shortness of breath, redness to injection site with warmth and tenderness. Administeration of Solumedrol 125mg IM at 5:00 PM 6/11/13.
Age: 30.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Rash
Clinical narrative: Received varicella vaccine and developed a rash all over scalp and back area. It is not reported that it is even possible to get the chickenpox after receiving the vaccine. I work in the healthcare field and am having to stay home due to this rash. Healthcare providers are not informed also of the risk of developing chickenpox after the vaccine.
Age: 5.0
Sex: M
Vaccine: DTAP, HIBV, PPV
Symptoms: Abnormal behaviour, Aggression, Convulsion, Hallucination
Clinical narrative: This spontaneous report was received from a mother regarding her 5 year old son. Pertinent medical history or drug reaction/allergies were not provided. On an unknown date, the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent)(manufacturer unknown) (dose, lot number and expiration date were not provided). Other suspect therapies included diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid (manufacturer unknown), and haemophilus b conjugate vaccine (manufacturer unknown) (doses, lot numbers, and expiration dates were not provided. Concomitant therapy was not provided. The mother stated that 4-5 years ago, her son experienced seizures after receiving an unspecified pneumococcal vaccine. The mother reported that her son experienced multiple seizures at different times after receiving a dose of diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid (manufacturer unknown); a dose of haemophilus b conjugate vaccine (manufacturer unknown); a dose of haemophilus b conjugate vaccine (manufacturer unknown); a dose of PC PNU vaccine (manufacturer unspecified), and a dose of 50 EBV vaccine (unspecified manufacturer). The mother also reported that her son also experienced odd behavior such as demonic ways, aggressiveness, and hallucinations after taking TAMIFLU on an unspecified date. At the time of the report, the patient outcome was unknown. Upon internal review, the event of seizures was considered to be medically significant. Additional information has been requested.
Sex: M
Vaccine: HPV4
Symptoms: Convulsion
Clinical narrative: This spontaneous report as received from a healthcare worker (a billing department employee) via company representative, refers to a male patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL (dose and lot number were not reported), intramuscular. Concomitant medications were not reported. On an unknown date, patient had a seizure in the car on the way home from the pediatric office after receiving an unspecified shot in the GARDASIL series. The patient was taken to an unspecified emergency room where he received unspecified treatment. On an unspecified date, the patient was fully recovered. The relationship between GARDASIL and seizure was not reported. Upon internal review the seizure was considered to be medically significant. This case is linked to case 1306USA003568 and case # 1306USA004931 via same reporter link. Additional information has been requested.
Sex: U
Vaccine: FLUN3
Symptoms: Condition aggravated, Neuropsychiatric syndrome
Clinical narrative: A report was received from a physician concerning a child patient of unknown gender. Medical history included PANS (pediatric acute neuropsychiatric disorder) during the 2009 H1N1 outbreak. The patient received nasal FLUMIST (intranasal) 18 months later and then relapsed after an unreported interval. At the time of reporting, the outcome of the event was unknown. The company physician assessed the event to be serious due to important medical event.
Age: 10.0
Sex: F
Vaccine: PPV
Symptoms: Rash
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 10 year old female patient. On an unknown date the patient was vaccinated with PNEUMOVAX 23 (lot number not provided)(route: unspecified injection). Approximately on 30-MAY-2013, "about one week ago" the patient experienced "a rash" after PNEUMOVAX 23 was administered. The outcome of rash was reported as recovered/resolved on an unspecified date. The patient had sought medical attention via office visit on an unspecified date. Additional information is not expected.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: This spontaneous report as received from a registered pharmacist refers to a 69 year old male patient. On 23-MAY-2013 the patient was vaccinated with ZOSTAVAX, 0.65 ml, subcutaneous, lot number H021710. The patient experienced a reddened area at injection site on 24-MAY-2013 (it was reported the patient had the redness for 7 days). He confirmed that there was no itching, pain or any kind of rash at injection site. No treatment was given. The patient had sought unspecified medical attention via visiting office. No laboratory test was performed. The outcome of a reddened area at injection site was reported as recovering. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from two pharmacists refers to an unspecified patient of unknown age. On 30-MAY-2013 the patient was vaccinated with an expired dose of ZOSTAVAX (lot # 0168AE, expiration date 06-MAR-2013). No adverse effect was reported. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: TDAP
Symptoms: Discomfort, Erythema, Musculoskeletal stiffness, Swelling
Clinical narrative: Swollen, red, stiff uncomfortable. Antibiotic given.
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: This spontaneous report was received from a nurse via a company representative refers to an unspecified number of female patients of unknown age. No medical history was reported. On an unknown date, the patients were vaccinated with dose of GARDASIL (lot #, expiry not reported). No concomitant medications were reported. The nurse of the physician reported to the representative that she had an unspecified number of female patients who had received GARDASIL and did not want to get their next dose because it hurt when they got the shot. Patient sought medical attention. Therapy with GARDASIL was discontinued. The outcome of the event was unknown. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a Healthcare Worker refers to a patient of unknown age. On 01-FEB-2008 the patient was vaccinated with the first dose of GARDASIL (lot number, dose, route and injection site were not reported). On 01-APR-2013 the patient was vaccinated with the second dose of GARDASIL (lot number, dose, route and injection site were not reported). No adverse event reported. The outcome and action taken were not provided. It was unspecified if the patient sought any medical attention. Additional information has been requested.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Dermatitis allergic, Injection site erythema, Injection site inflammation
Clinical narrative: Allergic skin rxn, redness, inflammation at injection site.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Dermatitis allergic, Injection site erythema, Injection site inflammation
Clinical narrative: Allergic skin rxn, redness and inflammation at injection site.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Local swelling, Rash, Skin warm
Clinical narrative: Red, slightly warm, slightly raised long rashspot on back of forearm.
Age: 3.0
Sex: F
Vaccine: MMR
Symptoms: Feeling abnormal, Somnolence
Clinical narrative: 15 min. after vaccine: sleepy, "dazed", lasted approx. 8 hours.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Body temperature increased, Nausea, Pain, Tremor, Vomiting
Clinical narrative: 7:00pm started vomiting, shaking, temp 102 degrees, body aches. Vomiting ended 3:00pm 6/5/13, temp lasted till 5:00am 6/6/13, shaking ended 3:00pm 6/5/13. Still feeling nausea and achy today.
Age: 21.0
Sex: F
Vaccine: FLU3, IPV, TYP, YF
Symptoms: Angioedema, Urticaria
Clinical narrative: Angioedema and urticaria.
Age: 1.51
Sex: M
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: No adverse events but Hep A was given at 3 mo interval instead of 6 mo.
Age: 80.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Activities of daily living impaired, Herpes zoster, Pain, Rash
Clinical narrative: Shingles - very bad. Shot did not help. Rash is going away after 4 weeks but pain is worse. Cannot function.
Age: 80.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Disability, Herpes zoster, Pain
Clinical narrative: Shingles - very bad. Shot did not help. Rash is going away after 4 weeks but pain is worse. Cannot function.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Injection site erythema, Injection site pain, Rash
Clinical narrative: (L) arm rash x2 days, tender at site of vaccine. Mild erythema surrounding (L) lower injection site measuring 1.5 cm. Circle of area affected yesterday approx 3cm x 7cm. No sign of cellulitis.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site inflammation, Injection site nodule, Injection site pain
Clinical narrative: Patient felt little ball in right upper arm after receiving last GARDASIL, ball persisted to grow and is tender. Patient was sent to hospital on 5-22-13. Patient advised hospital diagnosis is arm nodule inflammation. Patient was advised to use hot compression and follow up in a couple of days with doctor.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling
Clinical narrative: Swelling around injection site measuring 65 mm across.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Headache, Injection site swelling, Nausea
Clinical narrative: Swelling on arm where injection was, after 5 hrs. and headache and nausea. Tx: Prednisone x 5 days.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to a 15 year old female patient. No medical history was reported. On an unknown date in 2009, the patient was vaccinated with dose 1 of GARDASIL (lot#, expiry, route, dose not reported). On 07-JUL-2013, the patient was at the physician's office to receive her second dose of GARDASIL (lot#, expiry, route, dose not reported). No adverse effects reported. No concomitant medications were reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: This spontaneous report as received from a physician via field representative refers to unspecified number of patients. On an unknown date the patients was vaccinated with GARDASIL (strength, formulation, lot #, dose/frequency, route and duration were unspecified0 for prophylaxis. Physician might have had an unspecified number of patients that experienced syncope following vaccination with GARDASIL. The physician did not have specific information about the patient's syncope and informed the representative that the cases of syncope were previously reported. The representative reported that the physician might also have had patients that experienced syncope following vaccination with TDAP (manufacturer unspecified) and meningococcal vaccine (manufacturer unspecified). The outcome of syncope were unknown. Additional information is not expected.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling hot, Pruritus, Rash erythematous, Swelling
Clinical narrative: Large rash (red), slightly swelling. Patient assistant, itching, and warmth. Dr. recommended taking extra ZYRTEC once a day for 3 days.
Sex: M
Vaccine: HEP
Symptoms: Drug administration error, Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist concerning to a neonate (term baby) male patient who was born on 29-MAY-2013 to a Hepatitis B positive mother. On 29-MAY-2013, the patient was vaccinated with the first dose of RECOMBIVAX HB, 0.5 ml in the arm (route, lot number and expiration date were not provided). With the 12 hours of the first dose, the patient was re-vaccinated with the second dose of RECOMBIVAX HB. Other suspect therapies included H-BIG. Concomitant therapies included erythromycin as part of routine protocols for delivery. No adverse effect reported. The pharmacist reported that the neonate patient received RECOMBIVAX HB concomitantly with H-BIG and in the same area on the body (in the same arm). It was also reported by a physician that these two injections were supposed to be given in contralateral deltoid muscles. A Vaccine Specialist advised to revaccinate the child with RECOMBIVAX HB. This second dose was given within 12 hours of the first dose. The physician also reported that H-BIG alone provides 3 to 6 months of passive immunization against perinatal Hepatitis B even if the birth vaccine dose was not immunogenic. He also reported that he instructed the pharmacist not to give the second dose of RECOMBIVAX HB, but rather to wait for the first month and six months dose which would complete the appropriate 3 dose series. After 6 months, Hepatitis B antibodies should be measured. If the child is a non-responder, repeating a 3 dose series could be possible with the 6 doses being the maximum. Unfortunately, the neonate received 2 doses of RECOMBIVAX HB 12 hours apart on their first day of life. The physician was instructed to tell the mother to observe for fever, rash, excessive irritability or lethargy. At the time of reporting, the outcome of the events was unknown. At the time of the report, the patient was still in the hospital. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age, unknown gender. On 06-JUN-2013 the patient was vaccinated with an expired ZOSTAVAX (lot # 663334/1556X, expiry date 28-APR-2010). No adverse effects reported. It was unspecified if the patient had sought medical attention. Additional information has been requested.
Age: 45.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site oedema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: 6/4/13 Pt. received Tdap. 6/6 Pt. called clinic c/o swelling, redness and warmth at site. Advised to apply ice, take Ibuprofen and antihistamine. 6/7 seen in clinic, 5x5 cm area at site w/edema and warmth and itchinss. No pain, good ROM. No sx of cellulitis per Dr.
Age: 11.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: Left shoulder w/ firm, red, warm, painful induration measures 8cm x 12cm.
Age: 1.37
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Blister, Erythema, Injection site warmth
Clinical narrative: Mild warmth (L) thigh 2-3 days after vaccines. Erythema and cluster tiny vesicles developed 9 days after vaccines given.
Age: 37.0
Sex: M
Vaccine: PPV
Symptoms: Body temperature increased, Erythema, Mobility decreased, Skin warm, Tenderness
Clinical narrative: Pt called next day stating quarter sized erythema and localized tenderness. On 6/8 T=102.5 arm red and hot and was "hardly able to move it". Treated with cephalexin 500mg QID x 5 D.
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a Nurse Practitioner refers to a patient of unknown age. On 03-JUN-2013, the patient was vaccinated with a dose of VARIVAX (Merck) (lot #, dose and route not reported). The patient inadvertently received a dose of VARIVAX (Merck) instead of ZOSTAVAX (Merck). No symptoms reported. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Rash
Clinical narrative: Rash, fever.
Age: 22.0
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy, No adverse event, Pregnancy test positive
Clinical narrative: Information has been received from a registered nurse referring to a 22 year old female patient. The nurse reported that on 03-JUN-2013 the patient was administered a dose of VARIVAX (merck), 0.5 ml subcutaneously and a "pregnancy test was performed the same day" and returned results that the patient was pregnant when VARIVAX (merck) was administered. The nurse was unsure if this was the patient's first dose of VARIVAX (merck). No adverse effect reported. Additional information has been requested.
Age: 0.56
Sex: F
Vaccine: HIBV, PNC, RV5
Symptoms: Crying, Cyanosis, Respiratory arrest
Clinical narrative: 6/11/13 9:45am RMA gave patient oral rotavirus, PREVNAR/IM (patient crying). She stopped crying, breathing - turned blue and closed eyes after the administration of Hib/IM. She immediately called for help with Dr., NP this under RN went into the room where mom was holding patient upright, she was awake - breathing, no discoloration (grey/blue) noted. Patient responded to her mom appropriately. O2 SATs R/A 100% - no oxygen given. Pulse 98. Incident lasted less than 1 minute. Pt recovered immediately. Kept in clinic x 20 min for further observation without any problems.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: This spontaneous report as received from a healthcare worker (a billing department employee) via company representative, refers to a female patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL (dose, route, indication and lot number were not reported). Concomitant medications were not reported. On an unknown date, the patient experienced syncope after receiving GARDASIL series at the pediatric office. On an unspecified date, the patient were recovered from the syncope. The relationship between GARDASIL and seizure was not reported. This case is linked to case 1306USA002091 and case # 1306USA004931 via same reporter link. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Activities of daily living impaired, Injection site erythema, Injection site swelling, Pruritus generalised, Pyrexia
Clinical narrative: This spontaneous report as received from a registered pharmacist refers to a 68 year old female patient with no pertinent medical history and no drug reactions or allergies. On 30-MAY-2013, the patient was vaccinated with a dose of ZOSTAVAX (Lot # J001008, expiration date 24-APR-2014 (also reported as 14-APR-2014)) SQ. There were no concomitant medications. The pharmacist reported that on 30-MAY-2013, later that day, the patient experienced red bump around the injection site, fever and itchiness on the whole body. Also the patient was unable to get out for the last 5 days and she could not sit still. The patient did not receive treatment for the adverse events. There were no lab diagnosis or studies performed. At the time of the report, the patient was recovering. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Restlessness
Clinical narrative: This spontaneous report as received from a registered pharmacist refers to a 68 year old female patient with no pertinent medical history and no drug reactions or allergies. On 30-MAY-2013, the patient was vaccinated with a dose of ZOSTAVAX (Lot # J001008, expiration date 24-APR-2014 (also reported as 14-APR-2014)) SQ. There were no concomitant medications. The pharmacist reported that on 30-MAY-2013, later that day, the patient experienced red bump around the injection site, fever and itchiness on the whole body. Also the patient was unable to get out for the last 5 days and she could not sit still. The patient did not receive treatment for the adverse events. There were no lab diagnosis or studies performed. At the time of the report, the patient was recovering. Additional information has been requested.
Age: 1.52
Sex: F
Vaccine: DTAP, HEPA, HIBV, PNC13
Symptoms: Rash
Clinical narrative: Rash.
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a male patient of unknown age. Pertinent medical history and drug reactions allergies were not reported. On 07-JAN-2013, the patient was vaccinated with a first dose of ZOSTAVAX vial 19400 plaque-forming unit (PFU) (lot number was reported as 672605/1658AA, expiration date 21-JAN-2013) subcutaneous (dose was not reported). On 22-MAY-2013, the patient was vaccinated with a second dose of ZOSTAVAX vial 19400 plaque-forming unit (PFU) (lot number H018978, expiration date 15-JAN-2014) subcutaneous (dose was not reported). Concomitant medication was not reported. No adverse effects reported. Additional information has been requested.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, RV5
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a health professional regarding a 10 week old male patient. Pertinent medical history, drug reactions/allergies were not provided. On 03-JUN-2013 the patient was vaccinated with an expired dose of ROTATEQ, first dose, orally. (Lot #1845AA, expiration date on 01-JUN-2013). Co-suspect therapy and concomitant medication were not provided. No adverse symptoms were reported by the healthcare professional. Additional information has been requested.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Dizziness, Malaise, Nausea, Somnolence
Clinical narrative: Same day and next day after receiving shot: nausea, sleepiness and upset stomach, with occasional dizziness. She did not feel well felt better after a few days.
Age: 12.0
Sex: M
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: This spontaneous report was received from a registered nurse refers to a 12-year-old male patient. On 05-JUN-2013 the patient was vaccinated with dose 1, 0.5 milliliter (ml) GARDASIL (lot#, expiration date not reported), intramuscularly. On 06-JUN-2013, patient had a syncopal episode and sought medical attention at the physician's office. Patient had no history of previous syncopal episodes. No injuries occurred and no other syncopal episodes have occurred. Treatment was not rendered for the event. The outcome of syncopal episode was reported as recovering/resolving. Causality was not reported. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant regarding a female patient of unknown age with no pertinent medical history reported. In August 2012 (unspecified date) the patient was vaccinated with the first dose of GARDASIL (lot number and expiration date not reported) (dose, route and anatomical location not reported) for prophylaxis. No other suspect therapies or concomitant medications were reported. The medical assistant reported that the patient was at the physician's office to be administered her second dose of GARDASIL on 06-JUN-2013. No adverse effects were reported. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 65 year old female patient. On 28-MAY-2013 the patient was vaccinated with PNEUMOVAX23 (0.5 ml / once only, lot # H017759, expiration date 04-JUL-2014) subcutaneous. There was no concomitant medication reported. The patient called the physician's office to report having a high fever and redness and swelling at the injection site on 30-MAY-2013. No treatment was given for the events. The outcomes of the events were unknown. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Skin discolouration
Clinical narrative: Bluish spot on upper left arm.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site pain, Rash, Swelling
Clinical narrative: Pt. had shot yesterday (MENVEO vaccine). He asked for ADVIL this morning due to pain in (L) deltoid. This morning patient was training for wrestling and boxing and was on floor off and on. Rash started approx 12:30 PM. The swelling was worse prior to getting to the office. Treated with ice pack and told to take CLARITIN 10mg once daily.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain
Clinical narrative: 3 wks after shot, severe pain in arm at injection site.
Age: 1.17
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Eyelid oedema
Clinical narrative: She got DTaP #4 and Hib #4 at 10 A.M. At 11:30 AM swelling of eyelids (upper) R>L was noted - returned to clinic was seen.
Age: 0.16
Sex: M
Vaccine: DTAPHEPBIP, PNC13, RV1, DTAPHEPBIP, PNC13, RV1
Symptoms: Death, Foaming at mouth, Immediate post-injection reaction, Mouth haemorrhage, Pallor
Clinical narrative: Infant passed away during evening of April 19, 2013. Vaccinations given in the afternoon of April 19, 2013. Unknown if vaccine related.
Age: 0.16
Sex: M
Vaccine: DTAPHEPBIP, PNC13, RV1, DTAPHEPBIP, PNC13, RV1
Symptoms: Death
Clinical narrative: Infant passed away during evening of April 19, 2013. Vaccinations given in the afternoon of April 19, 2013. Unknown if vaccine related.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, HEPA, HPV4, HEPA, HPV4, MNQ
Symptoms: Altered state of consciousness, Gaze palsy, Joint contracture, Malaise, Opisthotonus
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a 13-year-old female patient. Current conditions include allergy to latex, patient reacts with a rash. On 10-JUN-2013, the patient was vaccinated with 0.5 milliliter (ml) GARDASIL (lot # H021608, expiration date 13-AUG-2015) administered intramuscularly and 0.5 ml of VAQTA (lot# 0535AE, expiration date 24-JAN-2015) intramuscularly. Concomitant medications included FLONASE. The patient had just received her vaccines "when she began to look very pale". The nurse had the patient sit down in a chair and after having a seat the patient began to arch her back, her hands turned in towards her wrists, her eyes started rolling, she put her head down, her body was shaking a bit and she wet herself. The patient was immediately taken to the Emergency Room (ER) in the same building. While in ER, a series of tests were performed. They included blood work, a chest X-ray, a Computed Axial Tomography (CAT) scan of her head without contrast and a urine culture (results not provided). She was also administered ZOFRAN intravenously. The patient experienced another seizure in the ER and was transported to the hospital for further treatment. The nurse reported that the patient was to have an unspecified pediatric neurologist evaluate her and run further unspecified tests if needed, along with specialized care if she would need to be admitted. The patient sought medical attention. The patient had not recovered from seizure. The reporter considered the event seizure had caused significant disability, hospitalization and to be life threatening. Upon internal review, seizure was considered to be a medically significant event. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, HEPA, HPV4, HEPA, HPV4, MNQ
Symptoms: Pallor, Posture abnormal, Urinary incontinence
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a 13-year-old female patient. Current conditions include allergy to latex, patient reacts with a rash. On 10-JUN-2013, the patient was vaccinated with 0.5 milliliter (ml) GARDASIL (lot # H021608, expiration date 13-AUG-2015) administered intramuscularly and 0.5 ml of VAQTA (lot# 0535AE, expiration date 24-JAN-2015) intramuscularly. Concomitant medications included FLONASE. The patient had just received her vaccines "when she began to look very pale". The nurse had the patient sit down in a chair and after having a seat the patient began to arch her back, her hands turned in towards her wrists, her eyes started rolling, she put her head down, her body was shaking a bit and she wet herself. The patient was immediately taken to the Emergency Room (ER) in the same building. While in ER, a series of tests were performed. They included blood work, a chest X-ray, a Computed Axial Tomography (CAT) scan of her head without contrast and a urine culture (results not provided). She was also administered ZOFRAN intravenously. The patient experienced another seizure in the ER and was transported to the hospital for further treatment. The nurse reported that the patient was to have an unspecified pediatric neurologist evaluate her and run further unspecified tests if needed, along with specialized care if she would need to be admitted. The patient sought medical attention. The patient had not recovered from seizure. The reporter considered the event seizure had caused significant disability, hospitalization and to be life threatening. Upon internal review, seizure was considered to be a medically significant event. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, HEPA, HPV4, HEPA, HPV4, MNQ
Symptoms: Blood test, Chest X-ray, Computerised tomogram head, Convulsion, Culture urine
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a 13-year-old female patient. Current conditions include allergy to latex, patient reacts with a rash. On 10-JUN-2013, the patient was vaccinated with 0.5 milliliter (ml) GARDASIL (lot # H021608, expiration date 13-AUG-2015) administered intramuscularly and 0.5 ml of VAQTA (lot# 0535AE, expiration date 24-JAN-2015) intramuscularly. Concomitant medications included FLONASE. The patient had just received her vaccines "when she began to look very pale". The nurse had the patient sit down in a chair and after having a seat the patient began to arch her back, her hands turned in towards her wrists, her eyes started rolling, she put her head down, her body was shaking a bit and she wet herself. The patient was immediately taken to the Emergency Room (ER) in the same building. While in ER, a series of tests were performed. They included blood work, a chest X-ray, a Computed Axial Tomography (CAT) scan of her head without contrast and a urine culture (results not provided). She was also administered ZOFRAN intravenously. The patient experienced another seizure in the ER and was transported to the hospital for further treatment. The nurse reported that the patient was to have an unspecified pediatric neurologist evaluate her and run further unspecified tests if needed, along with specialized care if she would need to be admitted. The patient sought medical attention. The patient had not recovered from seizure. The reporter considered the event seizure had caused significant disability, hospitalization and to be life threatening. Upon internal review, seizure was considered to be a medically significant event. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, HEPA, HPV4, HEPA, HPV4, MNQ
Symptoms: Gaze palsy, Joint contracture, Opisthotonus, Pallor, Posture abnormal
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a 13-year-old female patient. Current conditions include allergy to latex, patient reacts with a rash. On 10-JUN-2013, the patient was vaccinated with 0.5 milliliter (ml) GARDASIL (lot # H021608, expiration date 13-AUG-2015) administered intramuscularly and 0.5 ml of VAQTA (lot# 0535AE, expiration date 24-JAN-2015) intramuscularly. Concomitant medications included FLONASE. The patient had just received her vaccines "when she began to look very pale". The nurse had the patient sit down in a chair and after having a seat the patient began to arch her back, her hands turned in towards her wrists, her eyes started rolling, she put her head down, her body was shaking a bit and she wet herself. The patient was immediately taken to the Emergency Room (ER) in the same building. While in ER, a series of tests were performed. They included blood work, a chest X-ray, a Computed Axial Tomography (CAT) scan of her head without contrast and a urine culture (results not provided). She was also administered ZOFRAN intravenously. The patient experienced another seizure in the ER and was transported to the hospital for further treatment. The nurse reported that the patient was to have an unspecified pediatric neurologist evaluate her and run further unspecified tests if needed, along with specialized care if she would need to be admitted. The patient sought medical attention. The patient had not recovered from seizure. The reporter considered the event seizure had caused significant disability, hospitalization and to be life threatening. Upon internal review, seizure was considered to be a medically significant event. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, HEPA, HPV4, HEPA, HPV4, MNQ
Symptoms: Tremor, Urinary incontinence
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a 13-year-old female patient. Current conditions include allergy to latex, patient reacts with a rash. On 10-JUN-2013, the patient was vaccinated with 0.5 milliliter (ml) GARDASIL (lot # H021608, expiration date 13-AUG-2015) administered intramuscularly and 0.5 ml of VAQTA (lot# 0535AE, expiration date 24-JAN-2015) intramuscularly. Concomitant medications included FLONASE. The patient had just received her vaccines "when she began to look very pale". The nurse had the patient sit down in a chair and after having a seat the patient began to arch her back, her hands turned in towards her wrists, her eyes started rolling, she put her head down, her body was shaking a bit and she wet herself. The patient was immediately taken to the Emergency Room (ER) in the same building. While in ER, a series of tests were performed. They included blood work, a chest X-ray, a Computed Axial Tomography (CAT) scan of her head without contrast and a urine culture (results not provided). She was also administered ZOFRAN intravenously. The patient experienced another seizure in the ER and was transported to the hospital for further treatment. The nurse reported that the patient was to have an unspecified pediatric neurologist evaluate her and run further unspecified tests if needed, along with specialized care if she would need to be admitted. The patient sought medical attention. The patient had not recovered from seizure. The reporter considered the event seizure had caused significant disability, hospitalization and to be life threatening. Upon internal review, seizure was considered to be a medically significant event. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, HEPA, HPV4, HEPA, HPV4, MNQ
Symptoms: Gaze palsy, Nausea, Opisthotonus, Pallor, Posture abnormal
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a 13-year-old female patient. Current conditions include allergy to latex, patient reacts with a rash. On 10-JUN-2013, the patient was vaccinated with 0.5 milliliter (ml) GARDASIL (lot # H021608, expiration date 13-AUG-2015) administered intramuscularly and 0.5 ml of VAQTA (lot# 0535AE, expiration date 24-JAN-2015) intramuscularly. Concomitant medications included FLONASE. The patient had just received her vaccines "when she began to look very pale". The nurse had the patient sit down in a chair and after having a seat the patient began to arch her back, her hands turned in towards her wrists, her eyes started rolling, she put her head down, her body was shaking a bit and she wet herself. The patient was immediately taken to the Emergency Room (ER) in the same building. While in ER, a series of tests were performed. They included blood work, a chest X-ray, a Computed Axial Tomography (CAT) scan of her head without contrast and a urine culture (results not provided). She was also administered ZOFRAN intravenously. The patient experienced another seizure in the ER and was transported to the hospital for further treatment. The nurse reported that the patient was to have an unspecified pediatric neurologist evaluate her and run further unspecified tests if needed, along with specialized care if she would need to be admitted. The patient sought medical attention. The patient had not recovered from seizure. The reporter considered the event seizure had caused significant disability, hospitalization and to be life threatening. Upon internal review, seizure was considered to be a medically significant event. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, HEPA, HPV4, HEPA, HPV4, MNQ
Symptoms: Posturing, Unresponsive to stimuli, Urinary incontinence
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a 13-year-old female patient. Current conditions include allergy to latex, patient reacts with a rash. On 10-JUN-2013, the patient was vaccinated with 0.5 milliliter (ml) GARDASIL (lot # H021608, expiration date 13-AUG-2015) administered intramuscularly and 0.5 ml of VAQTA (lot# 0535AE, expiration date 24-JAN-2015) intramuscularly. Concomitant medications included FLONASE. The patient had just received her vaccines "when she began to look very pale". The nurse had the patient sit down in a chair and after having a seat the patient began to arch her back, her hands turned in towards her wrists, her eyes started rolling, she put her head down, her body was shaking a bit and she wet herself. The patient was immediately taken to the Emergency Room (ER) in the same building. While in ER, a series of tests were performed. They included blood work, a chest X-ray, a Computed Axial Tomography (CAT) scan of her head without contrast and a urine culture (results not provided). She was also administered ZOFRAN intravenously. The patient experienced another seizure in the ER and was transported to the hospital for further treatment. The nurse reported that the patient was to have an unspecified pediatric neurologist evaluate her and run further unspecified tests if needed, along with specialized care if she would need to be admitted. The patient sought medical attention. The patient had not recovered from seizure. The reporter considered the event seizure had caused significant disability, hospitalization and to be life threatening. Upon internal review, seizure was considered to be a medically significant event. Additional information has been requested.
Sex: F
Vaccine: PPV, PPV, PPV
Symptoms: Injection site bruising, Pyrexia
Clinical narrative: This spontaneous report was received from a doctor of pharmacy concerning a female patient of unknown age with no pertinent medical history and no drug reactions or allergies. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX23 (lot number and expiry date reported as H015780 and 11-JUN-2014 respectively). There were no concomitant medications. On an unknown date, the patient experienced fever, redness, bruising and swelling at the injection site after receiving PNEUMOVAX23. The patient also complained of feeling bad and as sick as she had ever been after the vaccination. The patient sought medical attention (two office visits to physician). It was unspecified if any treatment was given or if any lab tests were performed. The patient was recovering from the events at the time of reporting. The relatedness for events was unknown for PNEUMOVAX23. Pharmacist requested a lot check for PNEUMOVAX23. Additional information has been requested.
Sex: F
Vaccine: PPV, PPV, PPV
Symptoms: Feeling abnormal, Injection site bruising, Injection site erythema, Injection site swelling, Malaise
Clinical narrative: This spontaneous report was received from a doctor of pharmacy concerning a female patient of unknown age with no pertinent medical history and no drug reactions or allergies. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX23 (lot number and expiry date reported as H015780 and 11-JUN-2014 respectively). There were no concomitant medications. On an unknown date, the patient experienced fever, redness, bruising and swelling at the injection site after receiving PNEUMOVAX23. The patient also complained of feeling bad and as sick as she had ever been after the vaccination. The patient sought medical attention (two office visits to physician). It was unspecified if any treatment was given or if any lab tests were performed. The patient was recovering from the events at the time of reporting. The relatedness for events was unknown for PNEUMOVAX23. Pharmacist requested a lot check for PNEUMOVAX23. Additional information has been requested.
Sex: F
Vaccine: PPV, PPV, PPV
Symptoms: Pyrexia
Clinical narrative: This spontaneous report was received from a doctor of pharmacy concerning a female patient of unknown age with no pertinent medical history and no drug reactions or allergies. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX23 (lot number and expiry date reported as H015780 and 11-JUN-2014 respectively). There were no concomitant medications. On an unknown date, the patient experienced fever, redness, bruising and swelling at the injection site after receiving PNEUMOVAX23. The patient also complained of feeling bad and as sick as she had ever been after the vaccination. The patient sought medical attention (two office visits to physician). It was unspecified if any treatment was given or if any lab tests were performed. The patient was recovering from the events at the time of reporting. The relatedness for events was unknown for PNEUMOVAX23. Pharmacist requested a lot check for PNEUMOVAX23. Additional information has been requested.
Sex: F
Vaccine: PPV, PPV, PPV
Symptoms: Chest X-ray, Erythema, Face and mouth X-ray, Fatigue, Headache
Clinical narrative: This spontaneous report was received from a doctor of pharmacy concerning a female patient of unknown age with no pertinent medical history and no drug reactions or allergies. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX23 (lot number and expiry date reported as H015780 and 11-JUN-2014 respectively). There were no concomitant medications. On an unknown date, the patient experienced fever, redness, bruising and swelling at the injection site after receiving PNEUMOVAX23. The patient also complained of feeling bad and as sick as she had ever been after the vaccination. The patient sought medical attention (two office visits to physician). It was unspecified if any treatment was given or if any lab tests were performed. The patient was recovering from the events at the time of reporting. The relatedness for events was unknown for PNEUMOVAX23. Pharmacist requested a lot check for PNEUMOVAX23. Additional information has been requested.
Sex: F
Vaccine: PPV, PPV, PPV
Symptoms: Injection site nodule, Pyrexia, Skin warm, Urine analysis, Vomiting
Clinical narrative: This spontaneous report was received from a doctor of pharmacy concerning a female patient of unknown age with no pertinent medical history and no drug reactions or allergies. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX23 (lot number and expiry date reported as H015780 and 11-JUN-2014 respectively). There were no concomitant medications. On an unknown date, the patient experienced fever, redness, bruising and swelling at the injection site after receiving PNEUMOVAX23. The patient also complained of feeling bad and as sick as she had ever been after the vaccination. The patient sought medical attention (two office visits to physician). It was unspecified if any treatment was given or if any lab tests were performed. The patient was recovering from the events at the time of reporting. The relatedness for events was unknown for PNEUMOVAX23. Pharmacist requested a lot check for PNEUMOVAX23. Additional information has been requested.