chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: F
Vaccine: YF
Symptoms: Vomiting
Clinical narrative: On 8/1/13 began to have photo sensitivity and felt off balance while out hiking; felt dizzy when turning head. Took a fall and hit head. On 8/7/13 became nauseous/vomiting headache, hands and elbows became tingling - went to DR immediately - DR. felt it was a migraine related event. Sent home - continued to have photo sensitivity, balance problems. Returned to doctor 8/13/13. Improving slowly - remains off work.
Age: 14.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Fall, Gaze palsy, Pallor, Syncope
Clinical narrative: Syncopal episode within minutes of post vaccination. Client was sitting in waiting area of lobby - when mother hollered for "help" child had fainted and fell over in her chair to her side. Pale with circum pallor, and eyes rolled back. Place in Trendelenburg position immediately with fast recovery.
Age: 1.01
Sex: M
Vaccine: MMR, PNC13, VARCEL
Symptoms: Presyncope
Clinical narrative: Pt. experienced a vasovagal episode and was assessed by Dr. Pulse Ox applied and reading of 99% obtained.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Abdominal pain upper, Axillary pain, Back pain, Injection site pain, Neck pain
Clinical narrative: Pt given injection on 8-14-13, Rt deltoid, IM. Correct placement. Pain in Rt upper arm going to arm pit and shoulder with stomach cramps. Woke up at 5:00 AM now pain up to neck and Rt back. Small amt swelling and feels warm. Pt does not have a fever.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Skin warm, Swelling
Clinical narrative: Pt given injection on 8-14-13, Rt deltoid, IM. Correct placement. Pain in Rt upper arm going to arm pit and shoulder with stomach cramps. Woke up at 5:00 AM now pain up to neck and Rt back. Small amt swelling and feels warm. Pt does not have a fever.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Rash
Clinical narrative: Rash on stomach, back of neck and leg.
Age: 49.0
Sex: F
Vaccine: HEPA
Symptoms: Underdose
Clinical narrative: Pediatric dose Hep A vaccine given to an adult.
Age: 11.0
Sex: M
Vaccine: MNQ, TD
Symptoms: Wrong drug administered
Clinical narrative: Wrong vaccine given to patient. The provider ordered TDap and the medical assistant gave Td.
Age: 56.0
Sex: F
Vaccine: HEPAB, MEN
Symptoms: Dizziness, Feeling hot, Loss of consciousness, Nausea, Syncope
Clinical narrative: Few minutes after 2nd vaccine given, pt. complained felt dizzy and like she was going to faint. Sat her back down in chair. Pt then fainted or blacked out or possible small seizure -> was unresponsive to my voice for 30 seconds. Called 911. Pt came to . Said felt hot and had nausea. Got cold compress for head. Pt vomited a little. Medics arrived and checked pt out. Pt feeling better and refused to go to hospital.
Age: 56.0
Sex: F
Vaccine: HEPAB, MEN
Symptoms: Unresponsive to stimuli, Vomiting
Clinical narrative: Few minutes after 2nd vaccine given, pt. complained felt dizzy and like she was going to faint. Sat her back down in chair. Pt then fainted or blacked out or possible small seizure -> was unresponsive to my voice for 30 seconds. Called 911. Pt came to . Said felt hot and had nausea. Got cold compress for head. Pt vomited a little. Medics arrived and checked pt out. Pt feeling better and refused to go to hospital.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain upper, Chills, Hyperhidrosis, Malaise, Pyrexia
Clinical narrative: Sick, stomach pain, low grade fever, sweating, chills.
Age: 1.61
Sex: M
Vaccine: DTAP, HEPA, HIBV, PNC13
Symptoms: Injection site erythema
Clinical narrative: R thigh 5x5 cm erythematous lesion and L thigh 6x8 cm erythematous lesion decreasing size since 8/13/13; active and playful; No Tx req'd.
Age: 13.0
Sex: M
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Dizziness, Malaise, Pallor, Vomiting
Clinical narrative: Felt ill, vomiting, dizzy - looed pale. Had patient lay down and put cold towel on head.
Age: 15.0
Sex: M
Vaccine: HPV4
Symptoms: Nausea, Pallor
Clinical narrative: Pt. was waiting in waiting room - saw pt. sitting on couch. Saw he looked paled - looked like he was fainting, went right over to pt., got him laying down, held feet up and had front get another nurse/Dr. come help - we got pt. in wheelchair, took to room, lay him down on exam table, got cool wash cloth. Pt. felt better. Thought he was going to vomit but did not. We watch pt. They slowly got him up. BP where it was when he came in. Pt. left after Dr said ok. Nurse and Dr. help with situation.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Breast pain, Computerised tomogram, Pruritus
Clinical narrative: Pt pretreated with BENADRYL per MD orders. Itching began about 4 hrs after. Seen by MD next day b/c pt. reports darting pain in left breast region. Sent to ER given prednisone, VISTARIL, PEPCID. Also given CT scan with contrast then pain stopped.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Swelling at injection site, 2" diameter red raise spot. Burning and soreness.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling noted at injection site RD.
Age: 80.0
Sex: F
Vaccine: PPV
Symptoms: Inflammation, Pain, Swelling
Clinical narrative: Large local inflammatory reaction lasting several days followed by substantial pain and swelling.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL, DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Pt. has redness locally at injection site (R) arm in where KINRIX was given + (R) arm SQ where varicella was given with slight swelling and warmth. Mother provided child with TYLENOL and BENADRYL and ice pack. Child had no fever, nausea, vomiting or any other adverse signs.
Age: 65.0
Sex: M
Vaccine: PPV, PPV, PPV
Symptoms: Back pain, Guillain-Barre syndrome, Headache, Hypoaesthesia, Lethargy
Clinical narrative: This spontaneous report as received from a 65 year old male patient with allergy to penicillin and high blood pressure. On 12-JUN-2013 the patient was vaccinated with PNEUMOVAX23 (intramuscular, dosage unknown; lot # J001180 EXP 18-AUG-2014). Concomitant therapies included lisinopril (manufacturer unknown) 40 mg once daily, pantoprazole(manufacturer unknown) 40 mg, once daily and allopurinol(manufacturer unknown) 300 mg, once daily. On 20-JUN-2013, the patient was hospitalized (location, duration and demographics unspecified) and was diagnosed with Guillain-Barre syndrome. The patient had routine bloodwork lab diagnostics studies performed (unknown date and results). The patient sought medical attention. The outcome of the events was reported as recovering. Upon internal review Guillain-Barre syndrome was considered medically significant. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: PPV, PPV, PPV
Symptoms: Myalgia, Paraesthesia
Clinical narrative: This spontaneous report as received from a 65 year old male patient with allergy to penicillin and high blood pressure. On 12-JUN-2013 the patient was vaccinated with PNEUMOVAX23 (intramuscular, dosage unknown; lot # J001180 EXP 18-AUG-2014). Concomitant therapies included lisinopril (manufacturer unknown) 40 mg once daily, pantoprazole(manufacturer unknown) 40 mg, once daily and allopurinol(manufacturer unknown) 300 mg, once daily. On 20-JUN-2013, the patient was hospitalized (location, duration and demographics unspecified) and was diagnosed with Guillain-Barre syndrome. The patient had routine bloodwork lab diagnostics studies performed (unknown date and results). The patient sought medical attention. The outcome of the events was reported as recovering. Upon internal review Guillain-Barre syndrome was considered medically significant. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: PPV, PPV, PPV
Symptoms: Blood test, Guillain-Barre syndrome
Clinical narrative: This spontaneous report as received from a 65 year old male patient with allergy to penicillin and high blood pressure. On 12-JUN-2013 the patient was vaccinated with PNEUMOVAX23 (intramuscular, dosage unknown; lot # J001180 EXP 18-AUG-2014). Concomitant therapies included lisinopril (manufacturer unknown) 40 mg once daily, pantoprazole(manufacturer unknown) 40 mg, once daily and allopurinol(manufacturer unknown) 300 mg, once daily. On 20-JUN-2013, the patient was hospitalized (location, duration and demographics unspecified) and was diagnosed with Guillain-Barre syndrome. The patient had routine bloodwork lab diagnostics studies performed (unknown date and results). The patient sought medical attention. The outcome of the events was reported as recovering. Upon internal review Guillain-Barre syndrome was considered medically significant. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: PPV, PPV, PPV
Symptoms: Electromyogram abnormal, Gait disturbance, Guillain-Barre syndrome, Immune system disorder, Impaired work ability
Clinical narrative: This spontaneous report as received from a 65 year old male patient with allergy to penicillin and high blood pressure. On 12-JUN-2013 the patient was vaccinated with PNEUMOVAX23 (intramuscular, dosage unknown; lot # J001180 EXP 18-AUG-2014). Concomitant therapies included lisinopril (manufacturer unknown) 40 mg once daily, pantoprazole(manufacturer unknown) 40 mg, once daily and allopurinol(manufacturer unknown) 300 mg, once daily. On 20-JUN-2013, the patient was hospitalized (location, duration and demographics unspecified) and was diagnosed with Guillain-Barre syndrome. The patient had routine bloodwork lab diagnostics studies performed (unknown date and results). The patient sought medical attention. The outcome of the events was reported as recovering. Upon internal review Guillain-Barre syndrome was considered medically significant. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: PPV, PPV, PPV
Symptoms: Intensive care, Motor dysfunction, Muscle atrophy, Nerve degeneration, Plasmapheresis
Clinical narrative: This spontaneous report as received from a 65 year old male patient with allergy to penicillin and high blood pressure. On 12-JUN-2013 the patient was vaccinated with PNEUMOVAX23 (intramuscular, dosage unknown; lot # J001180 EXP 18-AUG-2014). Concomitant therapies included lisinopril (manufacturer unknown) 40 mg once daily, pantoprazole(manufacturer unknown) 40 mg, once daily and allopurinol(manufacturer unknown) 300 mg, once daily. On 20-JUN-2013, the patient was hospitalized (location, duration and demographics unspecified) and was diagnosed with Guillain-Barre syndrome. The patient had routine bloodwork lab diagnostics studies performed (unknown date and results). The patient sought medical attention. The outcome of the events was reported as recovering. Upon internal review Guillain-Barre syndrome was considered medically significant. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: PPV, PPV, PPV
Symptoms: Tremor
Clinical narrative: This spontaneous report as received from a 65 year old male patient with allergy to penicillin and high blood pressure. On 12-JUN-2013 the patient was vaccinated with PNEUMOVAX23 (intramuscular, dosage unknown; lot # J001180 EXP 18-AUG-2014). Concomitant therapies included lisinopril (manufacturer unknown) 40 mg once daily, pantoprazole(manufacturer unknown) 40 mg, once daily and allopurinol(manufacturer unknown) 300 mg, once daily. On 20-JUN-2013, the patient was hospitalized (location, duration and demographics unspecified) and was diagnosed with Guillain-Barre syndrome. The patient had routine bloodwork lab diagnostics studies performed (unknown date and results). The patient sought medical attention. The outcome of the events was reported as recovering. Upon internal review Guillain-Barre syndrome was considered medically significant. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Dizziness, Feeling cold, Headache, Malaise
Clinical narrative: This spontaneous report was received from a 67 year old female patient via a sales representative, reporting on herself. The patient's medical history included heart catheterization and two stents placements on 09-AUG-2013 (the patient was hospitalized due to this procedures). Patient's medical history also included open heart bypass and three previous stents placement. Drug reactions/allergies were not provided. The patient reported that 24 hours after heart catheterization and stents placement, on 10-AUG-2013 at 10:48 AM, the patient received a dose of PNEUMOVAX23 (dose, route, lot number and expiration date were not provided). Co-suspect therapy and concomitant medications were not provided. One hour after vaccination, on 10-AUG-2013 at 11:48 AM approximately, the patient "got very very sick". Post vaccination, the patient developed nausea, headache, dizziness, some vomiting, and felt cold. Patient stated that she might had developed a slight fever. Due to the effects she was experiencing, the hospital staff gave her an unspecified IV and monitored her till that evening. She was to be released from hospital on 10-AUG-2013, but discharge time was delayed/prolonged for several hours. Patient stated she was released on the same day, on 10-AUG-2013, at 06:30PM that night. The patient stated: "I have had stents placed before without this reaction, could this have been a reaction to the vaccine?" At the time of the report, the patient "was feeling better", however she reported on approximately 12-AUG-2013 she was feeling weak. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Nausea, Vomiting
Clinical narrative: This spontaneous report was received from a 67 year old female patient via a sales representative, reporting on herself. The patient's medical history included heart catheterization and two stents placements on 09-AUG-2013 (the patient was hospitalized due to this procedures). Patient's medical history also included open heart bypass and three previous stents placement. Drug reactions/allergies were not provided. The patient reported that 24 hours after heart catheterization and stents placement, on 10-AUG-2013 at 10:48 AM, the patient received a dose of PNEUMOVAX23 (dose, route, lot number and expiration date were not provided). Co-suspect therapy and concomitant medications were not provided. One hour after vaccination, on 10-AUG-2013 at 11:48 AM approximately, the patient "got very very sick". Post vaccination, the patient developed nausea, headache, dizziness, some vomiting, and felt cold. Patient stated that she might had developed a slight fever. Due to the effects she was experiencing, the hospital staff gave her an unspecified IV and monitored her till that evening. She was to be released from hospital on 10-AUG-2013, but discharge time was delayed/prolonged for several hours. Patient stated she was released on the same day, on 10-AUG-2013, at 06:30PM that night. The patient stated: "I have had stents placed before without this reaction, could this have been a reaction to the vaccine?" At the time of the report, the patient "was feeling better", however she reported on approximately 12-AUG-2013 she was feeling weak. Additional information has been requested.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a consumer refers to her sister, a 76 year old female patient. On an unknown date of several years ago the patient was vaccinated with a dose of ZOSTAVAX (dose, route and lot # not reported). Recently (approximately in 2013) the patient was diagnosed with shingles. The outcome of the event was unknown. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: VARCEL
Symptoms: Incomplete course of vaccination, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 20 year old patient. When approximately 5 years old, in approximately 1998 the patient was vaccinated with a first dose of VARIVAX (Merck) (dose, route and lot # unknown) and never received the second dose. No adverse symptoms reported. Pharmacist stated the patient will now be entering radiology school and the school is requiring that 2 doses of VARIVAX (Merck) be administered. Pharmacist mentioned no titers had been drawn for this patient. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse refers to a 4 year old unknown gender patient received an expired 0.5ml dose of VARIVAX (Merck) (lot # 670709/0820AA, expiration date: 02-JUN-2013) subcutaneous at unspecified location on 09-AUG-2013. No adverse effects reported. At the time of report, the outcome of the events was unknown. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report was received from a other health professional concerning a patient of unknown age and gender. On 05-AUG-2013, the patient was vaccinated with a dose of VARIVAX (Merck) (Lot # J006109; exp 21-MAY-2015) (route and dose not reported. No other co-suspect therapy was reported. Concomitant medications were not provided. It was reported that the dose of VARIVAX (Merck) underwent an unsupported temperature excursion, was administered to a patient on 05-AUG-2013. This dose VARIVAX (Merck) was also administered to two other patients (MARRS# 1308USA005478 and MARRS# 1308USA005274). At the time of reporting, patient's outcome was unknown. This is one of several reports from the same source. Additional information has been requested.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, No adverse event, Syringe issue
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 05-JUN-2013 the patient was vaccinated with ZOSTAVAX (lot number not provided). The patient received a less than recommended dose because it leaked from the syringe during the vaccination due to a human error. No adverse effect was reported. Follow up information was received from the pharmacist concerning an 83 year old white female patient. Date of birth of the patient was updated. Height of the patient was updated. Weight of the patient was reported as 180 (units unspecified). Contact details of the patient and the responsible physician were updated. On 05-JUN-2013, at 11:00 am, the patient did not get the complete dose as the syringe leaked (previously captured as underdose) while administering the ZOSTAVAX. After consulting with the company representative, the vaccine was repeated (overdose). On 05-JUN-2013, at 11:00 am, the patient was vaccinated with dose 2 ZOSTAVAX (lot number reported as H018510, expiry date unspecified) in the right upper arm. There was no illness at the time of vaccination. A signed informed consent form was obtained. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a patient of unknown age. On an unknown date the patient was vaccinated with a dose of improperly stored GARDASIL (lot # H015863, expiration 24-FEB-2015) (dose not reported), intramuscularly. No adverse effect of the patient has been reported. This is one of several reports received from same source. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to a 12 year old female patient. On 13-AUG-2013, the patient was vaccinated with an expired dose of GARDASIL, (lot number 0636AA, expiry date 11-AUG-2013, route not reported). No adverse effects were reported. This is one of the two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: This spontaneous report as received from a physician refers to unspecified number of patients. On unknown dates the patients was vaccinated with a dose of GARDASIL (dose, route, lot number unknown). Physician reported that unspecified number of patients experienced syncope after receiving GARDASIL. The outcome of syncope was unknown. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a patient of unknown age. On an unknown date the patient was vaccinated with a dose of improperly stored GARDASIL (lot # H017698, expiration 02-JUL-2015) (dose unknown), intramuscularly. No adverse effect of the patient has been reported. This is one of several reports received from same source. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Rash erythematous, Rash pruritic, Skin warm
Clinical narrative: This spontaneous report as received from a 60 years old female physician assistant (also reported as nurse practitioner) of unknown age via company representative refers to herself. On 30-JUL-2013 the patient was vaccinated with ZOSTAVAX (lot number not provided) subcutaneously in the right arm. Concomitant therapies included TDAP. She experienced a red, hot, itchy rash post vaccination with ZOSTAVAX. No treatment was given for adverse events. Duration of rash was one week and one day and the rash had resolved. The patient did not seek medical attention. Additional information ha been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a physician refers to a patient of unknown age. On an unknown date in November 2012, the patient was vaccinated with first dose of GARDASIL, (lot  number, expiry date and route was not reported). On an unknown date in April 2013, the patient was vaccinated with second dose of GARDASIL, (lot number, expiry date and route was not reported). No adverse effect was reported. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Accidental exposure to product, No adverse event, Product quality issue, Syringe issue
Clinical narrative: This spontaneous report was received from an office manager refers to a female patient (medical assistant) of unknown age. On an unknown date the patient had RECOMBIVAX HB (lot # H010380 and expiration date 18-NOV-2014) spill on her hands after the plunger rod and stopper fell out of the prefilled syringe. No adverse effects reported. Product quality complaint filed. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash pruritic
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 65 year old male patient with diabetes, high cholesterol, chronic obstructive pulmonary disease (COPD) and gastroesophageal reflux disease (GERD). The patient's medical history included coronary artery disease, back pain and crestor which caused elevated liver enzymes. On 24-JUL-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot # J001003, expiry : 24-APR-2014). Concomitant therapies included acetaminophen with codeine, albuterol nebulizer (manufacturer unknown), aspirin 81 mg, glyburide, metformin, methocarbamol, omeprazole, simvastatin (manufacturer unknown), tiotropium bromide, gabapentin, dutasteride and tamsulosin hydrochloride. On 25-JUL-2013, the patient experienced shingles rash two days after vaccination with ZOSTAVAX. The pharmacist reported that the patient described the shingles rash as a rash on the front of his chest from his armpit to his chest that is red, itchy and painful (like mosquito bites). Patient sought medical attention-contacted pharmacist. No treatment was given. No laboratory tests were performed. The outcome of shingles rash was reported as not recovered. Additional information is not expected.
Age: 34.0
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy, Product label confusion, Wrong drug administered
Clinical narrative: This spontaneous prospective pregnancy report was received from a healthcare worker refers to a 34 year old female patient with autoimmune urticaria. No drug reactions were reported. On 09-AUG-2013, the pregnant patient was inadvertently vaccinated with a dose of GARDASIL (lot #, expiry not reported), 0.5 ml, intramuscularly. The patient became pregnant with LMP of 12-JAN-2013 and EDD of 19-OCT-2013. Concomitant therapies included ALLEGRA and PLAQUENIL. Initial exposure to GARDASIL was at 30 weeks. The pregnancy outcome was pending. The healthcare worker reported that this patient was intended to receive TDaP vaccine manufactured by GlaxoSmithKline. The caller stated that she picked up the wrong vaccine vial due to the similarities in the color of the labels between the 2 vaccine vials. No laboratory tests were performed. Additional information is not expected.
Sex: U
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 patient of unknown age. On an unknown date in 2011 (reported as 2 years ago), the patient was vaccinated with first dose of GARDASIL, (lot number, expiry date and route was not reported). On 13-AUG-2013, the patient was vaccinated with second dose of GARDASIL, (lot number, expiry date and route was not reported). No adverse effects was reported. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to an unknown number of patients. Patients might have received doses of GARDASIL (dose, route and lot # unknown) on an unspecified date which were exposed to 30F over the 3 months period. No adverse effects reported. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: HPV4
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to a male patient of unknown age. On 13-AUG-2013, the patient was vaccinated with an expired, second dose of GARDASIL, (lot number 0636AA, expiry date, 11-AUG-2013, route not reported). No adverse effects were reported. This is one of the two reports received  from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a patient of unknown age. On an unknown date the patient was vaccinated with a dose of improperly stored GARDASIL (lot # H015863, expiration 24-FEB-2015) (dose unknown), intramuscularly. No adverse effect of the patient has been reported. This is one of several reports received from same source. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a patient's mother refers to her daughter of unknown age. The patient was mistakenly given the first dose of GARDASIL (route, dose and lot # were unknown) at an office visit in March 2010 and had not elected to receive the second or third dose of GARDASIL. No adverse effect reported. Additional information is not expected.
Sex: F
Vaccine: HEP
Symptoms: Brain injury, Cerebrovascular accident, Congenital central nervous system anomaly, Convulsion, Foetal exposure during pregnancy
Clinical narrative: This retrospective pregnancy case was reported by a consumer (mother of subject) and described the occurrence of stroke in a female foetus subject who was exposed to ENGERIX B (GlaxoSmithKline), FLUARIX during pregnancy. A physician or other health care professional has not verified this report. Parent medical history involved the mother considered to be a high risk pregnancy "as she has no thyroid." The subject's mother received the 3rd dose of hepatitis B vaccine recombinant; GlaxoSmithKline; unknown; unknown given "after the baby's delivery" in 2012. The subject's mother did not report if she was breast feeding the subject. On October 2011 at 13:00 and September 2011 at 13:00 the mother of unknown age received 2nd dose and 1st dose of ENGERIX B (transplacentary, unknown details). In September 2011 the subject's mother received unspecified dose of Influenza vaccine (transplacentary, unknown details). The subject was exposed to ENGERIX B and influenza vaccine unspecified "between 16 and 25 weeks gestation" during the 2nd trimester. The date of delivery was reported and weighed 3.8 kilograms. The method of delivery, gestational age at delivery were not reported. On 24 March 2012, 11 days after birth, the subject experienced seizures and was admitted to the hospital for 4 days. After discharge, the subject's mother noticed the subject was not using the left side of her body" (left or right sided weakness etiology unknown) and "held her hand tightly with the thumb inside her hand which she referred to as cortical thumb" (cortical thumbing). It was unclear as to the onset of the left or right sided weakness etiology unknown as the mother also reported that the subject "was not moving left side of her body" as "ongoing since birth". At 7 months of age, the subject was evaluated by neurology. The subject had 2 MRIs (nuclear magnetic resonance imaging). The mother was told that the subject "had a stroke in utero some time before 26 weeks gestation." The mother was also told that the subject "had brain damage as the right side of the baby's brain was half the size of the left side (congenital brain anomaly NOS)." The subject's mother considered this to be a congenital anomaly "as that is what the doctor said." The subject's mother reported that the subject was "now walking but walks with a limp and leads with the right side of her body and holds the left hand like a claw (claw hand)." At the time of reporting, the subject was receiving physical therapy. At the time of reporting, the subject had not had any seizures since discharge from the hospital and the subject did not take any medication. At the time of reporting the outcome of the events were unspecified.
Sex: F
Vaccine: HEP
Symptoms: Gait disturbance, Hand deformity, Hemiparesis, Muscle spasticity, Nuclear magnetic resonance imaging brain abnormal
Clinical narrative: This retrospective pregnancy case was reported by a consumer (mother of subject) and described the occurrence of stroke in a female foetus subject who was exposed to ENGERIX B (GlaxoSmithKline), FLUARIX during pregnancy. A physician or other health care professional has not verified this report. Parent medical history involved the mother considered to be a high risk pregnancy "as she has no thyroid." The subject's mother received the 3rd dose of hepatitis B vaccine recombinant; GlaxoSmithKline; unknown; unknown given "after the baby's delivery" in 2012. The subject's mother did not report if she was breast feeding the subject. On October 2011 at 13:00 and September 2011 at 13:00 the mother of unknown age received 2nd dose and 1st dose of ENGERIX B (transplacentary, unknown details). In September 2011 the subject's mother received unspecified dose of Influenza vaccine (transplacentary, unknown details). The subject was exposed to ENGERIX B and influenza vaccine unspecified "between 16 and 25 weeks gestation" during the 2nd trimester. The date of delivery was reported and weighed 3.8 kilograms. The method of delivery, gestational age at delivery were not reported. On 24 March 2012, 11 days after birth, the subject experienced seizures and was admitted to the hospital for 4 days. After discharge, the subject's mother noticed the subject was not using the left side of her body" (left or right sided weakness etiology unknown) and "held her hand tightly with the thumb inside her hand which she referred to as cortical thumb" (cortical thumbing). It was unclear as to the onset of the left or right sided weakness etiology unknown as the mother also reported that the subject "was not moving left side of her body" as "ongoing since birth". At 7 months of age, the subject was evaluated by neurology. The subject had 2 MRIs (nuclear magnetic resonance imaging). The mother was told that the subject "had a stroke in utero some time before 26 weeks gestation." The mother was also told that the subject "had brain damage as the right side of the baby's brain was half the size of the left side (congenital brain anomaly NOS)." The subject's mother considered this to be a congenital anomaly "as that is what the doctor said." The subject's mother reported that the subject was "now walking but walks with a limp and leads with the right side of her body and holds the left hand like a claw (claw hand)." At the time of reporting, the subject was receiving physical therapy. At the time of reporting, the subject had not had any seizures since discharge from the hospital and the subject did not take any medication. At the time of reporting the outcome of the events were unspecified.
Age: 24.0
Sex: M
Vaccine: SMALL
Symptoms: Blister, Erythema, Feeling abnormal, Injection site discolouration, Injection site swelling
Clinical narrative: VASCULITIS, PROGRESSIVE LEFT SHOULDER SWELLING CIRCUMFERENTIAL TO THE INOCULATION SITE WITH INCREASED VIOLACEOUS COLORATION. PT FEELS "A LITTLE OFF" C/O NOTABLE ITCH IN THE REACTION OF ERYTHEMA. C/O REDNESS, SWELLING, TENDERNESS. INCREASED VIOLACEOUS COLORATION, INCREASED ERYTHEMA MEDIALLY AND DISTALLY, PETECHIAE AND SMALL VESICLES NOTED.
Age: 24.0
Sex: M
Vaccine: SMALL
Symptoms: Petechiae, Pruritus, Swelling, Tenderness, Vasculitis
Clinical narrative: VASCULITIS, PROGRESSIVE LEFT SHOULDER SWELLING CIRCUMFERENTIAL TO THE INOCULATION SITE WITH INCREASED VIOLACEOUS COLORATION. PT FEELS "A LITTLE OFF" C/O NOTABLE ITCH IN THE REACTION OF ERYTHEMA. C/O REDNESS, SWELLING, TENDERNESS. INCREASED VIOLACEOUS COLORATION, INCREASED ERYTHEMA MEDIALLY AND DISTALLY, PETECHIAE AND SMALL VESICLES NOTED.
Age: 75.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Herpes zoster, Pain, Rash
Clinical narrative: Rash appeared, then blisters and soreness around my waist on right side. Dr. visit on 8/15 confirmed shingles. Prescribed antiviral medication.
Age: 75.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Generalised erythema, Herpes zoster, Hypersensitivity, Rash
Clinical narrative: Rash appeared, then blisters and soreness around my waist on right side. Dr. visit on 8/15 confirmed shingles. Prescribed antiviral medication.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Asthenia, Dizziness, Malaise
Clinical narrative: General ill feeling (weak and faint) for two days following the vaccine.
Age: 20.0
Sex: M
Vaccine: HEP
Symptoms: Nausea, Pyrexia, Vomiting
Clinical narrative: Nausea at 09:00pm then slight fever, vomiting 04:00am. No treatment. Symptoms subsided aprox. 02:00pm 8/14/2013.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Dysgeusia
Clinical narrative: Heavy metallic taste in mouth after driving a few miles away from pharmacy. No other medication to interact with this dose and have not experienced this prior. Did this vaccine as a requirement to apply to medical school. My concern is that there might be Hg mm in it.
Age: 1.53
Sex: M
Vaccine: HEPA, HIBV, MMR, VARCEL
Symptoms: Pyrexia, Rash erythematous, Rash generalised, Rash pruritic
Clinical narrative: Mom says pt woke up with all over body itchy red rash this morning.  She further states he had a fever 2 days ago.
Age: 57.0
Sex: M
Vaccine: DTAP
Symptoms: Dizziness postural, Fatigue, Hunger, Hyperaesthesia, Hypoaesthesia
Clinical narrative: Sensitive skin from upper waist down, numbness in legs and feet, loss of muscle tone in legs, light headedness upon standing, tiredness, increased hunger and thirst, loss of 20 lbs since vacination.
Age: 57.0
Sex: M
Vaccine: DTAP
Symptoms: Hypotonia, Thirst, Weight decreased
Clinical narrative: Sensitive skin from upper waist down, numbness in legs and feet, loss of muscle tone in legs, light headedness upon standing, tiredness, increased hunger and thirst, loss of 20 lbs since vacination.
Age: 8.0
Sex: F
Vaccine: TD, VARCEL
Symptoms: Erythema, Local swelling
Clinical narrative: Golf ball sized swelling and redness that increased to softball size per mom. In office on 08/16/2013 area measures 3in x 3.5in.
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis at injection site.
Age: 0.16
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Cough, Decreased eye contact, Dyskinesia, Dysphonia, Eating disorder
Clinical narrative: Stopped making eye contact, no longer cooing or smiling, not responding to parents.  Slept a lot.  No fevers. Poor eating.  Also with jerky movements during sleep and occ during day.  His voice also seemed "hoarse" with an occ cough and some congestion.  Whimpering while sleeping.
Age: 0.16
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Hypersomnia, Respiratory tract congestion, Sleep disorder, Unresponsive to stimuli
Clinical narrative: Stopped making eye contact, no longer cooing or smiling, not responding to parents.  Slept a lot.  No fevers. Poor eating.  Also with jerky movements during sleep and occ during day.  His voice also seemed "hoarse" with an occ cough and some congestion.  Whimpering while sleeping.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Erythema, Injection site swelling
Clinical narrative: Received injections at approx. 9:30 AM, and during early evening the patient developed redness and mild swelling at injection sites.  On 08/14/2013 upon wakening the patient's mother noticed "her back was fire engine red."
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Loss of consciousness, Urinary incontinence
Clinical narrative: About 2 minutes after getting shot, patient was found laying on ground passed out in front of pharmacy while his father held him.  He appeared to be passed out for about 15-20 seconds.  Pt. had pulse and was breathing. Emergency response was activated.  Pt. urinated on himself.  Pt. remained on ground after he came to for about 10 minutes just so we could make sure he was ok.  We gave him an ice pack and some water.  Pt. was evaluated by the emergency response team and did not want to be taken away in ambulance.  Checked in with patient and hour later, and father said he was doing fine.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: Swelling and redness left elbow to shoulder; Seen in ER with diagnosis of cellulitis; Treatment: Prednisone, regimen of Keflex 250 mg 1 po q 6 hrs x 10 days and Tylenol #3 PRN.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Hypersensitivity, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Mom called to say that her daughter had an allergic reaction to the vaccine given in the back of her left arm.  Mom stated that the client's symptoms were tenderness to the area, redness, swelling, and the area was warm to touch.
Age: 61.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site joint pain
Clinical narrative: Left shoulder pain with elevating above horizon and internal rotation.
Age: 1.05
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Pyrexia, Rash generalised
Clinical narrative: Started with fever of around 101 on and off and the all over body rash.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Tachycardia, Throat tightness
Clinical narrative: Pt mom reports that pt felt her throat was getting tight 20 minutes after vaccine, then experienced tachycardia. Mom reports gave Benadryl and symptoms subsided.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Musculoskeletal stiffness, Staring, Tension, Tremor
Clinical narrative: After she received iz's, she was very quiet and then she seemed to stiffen and get tense, eyes stared off and she started to shake.
Age: 36.0
Sex: F
Vaccine: MMR, TDAP, VARCEL
Symptoms: Oedema peripheral, Pain in extremity, Pruritus
Clinical narrative: Swelling, soreness, itching Lt. arm.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Rash, Respiratory rate increased, Throat irritation
Clinical narrative: Rashes and itchy throat, rapid resp.
Age: 25.0
Sex: F
Vaccine: DTAP
Symptoms: Local swelling, Lymph node pain, Tenderness
Clinical narrative: Tenderness above left collar bone. Feels like sore lymph node. Next morning that area was even more tender and was swollen.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Fatigue, Injection site inflammation, Injection site nodule, Injection site pain
Clinical narrative: 8" inflammation ring and 3" raised knot around injection sight.  Sight was warm, slightly itchy, tender to the touch. diarrhea, and extreme fatigue morning of 8/16.  7:25 p.m. took Zyrtec.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site warmth
Clinical narrative: 8" inflammation ring and 3" raised knot around injection sight.  Sight was warm, slightly itchy, tender to the touch. diarrhea, and extreme fatigue morning of 8/16.  7:25 p.m. took Zyrtec.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Skin warm, Swelling
Clinical narrative: 3x5 are of redness swelling pain and hot area. Has spread throughout the day into armpit. Now area is about 9 inches long. Pains are shooting type.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMRV
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: SWELLING AND REDNESS APPROX 7 CM IN SIZE. CHILD C/O ITCHING.
Age: 19.0
Sex: M
Vaccine: PPV
Symptoms: Blood pressure increased, Erythema, Feeling cold, Headache, Heart rate increased
Clinical narrative: He started feeling cold.  Came home from work with a severe headache, fever, swollen extremely painful arm, rash, puffy red face, accelerated heart rate, numbness in his face, hands, feet.  It progressed to worse.  Ended up in the ER two times.
Age: 19.0
Sex: M
Vaccine: PPV
Symptoms: Hypoaesthesia, Oedema peripheral, Pain in extremity, Pyrexia, Rash
Clinical narrative: He started feeling cold.  Came home from work with a severe headache, fever, swollen extremely painful arm, rash, puffy red face, accelerated heart rate, numbness in his face, hands, feet.  It progressed to worse.  Ended up in the ER two times.
Age: 19.0
Sex: M
Vaccine: PPV
Symptoms: Swelling face, White blood cell count increased
Clinical narrative: He started feeling cold.  Came home from work with a severe headache, fever, swollen extremely painful arm, rash, puffy red face, accelerated heart rate, numbness in his face, hands, feet.  It progressed to worse.  Ended up in the ER two times.
Sex: U
Vaccine: VARCEL
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. On 13-AUG-2013 the patient was vaccinated with VARIVAX (Merck) (lot # G007814, expiration date 10-AUG-2013) injection, 0.5 ml, subcutaneously. The healthcare worker reported that the patient received an expired dose of VARIVAX (Merck). No adverse effect reported. Additional information has been requested.
Age: 80.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Fall, Haemorrhage, Swelling
Clinical narrative: After the shot, she was shopping. About 10 min. later, she fell down with a case of wine. We call 911. She was bleeding from head. Head is swollen. She had flu shot here before without any problem.
Age: 80.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Cerebral haemorrhage, Dizziness, Syncope
Clinical narrative: After the shot, she was shopping. About 10 min. later, she fell down with a case of wine. We call 911. She was bleeding from head. Head is swollen. She had flu shot here before without any problem.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Body temperature increased, Nausea, Vomiting
Clinical narrative: 6-11-13 received Tdap at physical from 6/12/13 mom called office and stated child began N/V within 12 hrs of receiving vaccine, Temp 104+ 6/13/13 TC to mom she states child is fever free by late morning. Drinking OK now.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Left leg (thigh area) has a hard bump and is red around the injection site, and warm to the touch.
Age: 18.0
Sex: M
Vaccine: MNQ, TDAP, MNQ
Symptoms: Chills, Fatigue, Headache, Pyrexia
Clinical narrative: 8/15/13 headache (severe), chills, fatigue, fever (unsure of how high). 8/15/13 went to Urgent Care. 8/15/13 sent to ER by urgent care physician. 8/15/13 released after 5 or 6 hours, pt feeling better.
Age: 18.0
Sex: M
Vaccine: MNQ, TDAP, MNQ
Symptoms: Chills, Fatigue, Headache, Incorrect dose administered, Incorrect route of drug administration
Clinical narrative: 8/15/13 headache (severe), chills, fatigue, fever (unsure of how high). 8/15/13 went to Urgent Care. 8/15/13 sent to ER by urgent care physician. 8/15/13 released after 5 or 6 hours, pt feeling better.
Age: 18.0
Sex: M
Vaccine: MNQ, TDAP, MNQ
Symptoms: Injection site pain, Pyrexia
Clinical narrative: 8/15/13 headache (severe), chills, fatigue, fever (unsure of how high). 8/15/13 went to Urgent Care. 8/15/13 sent to ER by urgent care physician. 8/15/13 released after 5 or 6 hours, pt feeling better.
Age: 20.0
Sex: F
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: Pt. had rashes on hand about 2 hours after vaccine. Took BENADRYL and on 8/16/13 at 10:20 AM said rashes are gone.
Age: 6.0
Sex: M
Vaccine: DTAPIPV, HEPA, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: 08/14/13 Right arm swollen from shoulder to elbow, very red, diameter of a softball, hard to touch, itches, no fever, breathing normal. No pain. Mom treated with BENADRYL and iced arm. Call into doctor.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, PNC13, VARCEL
Symptoms: Injection site discolouration, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Circular area over R deltoid-reddish/tan in color approx 1 1/2 in ht et 2 2 1/2 in width. Initially warm to touch et swollen. Today no warmness or edema. No pain just discoloration. To PMD.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Death
Clinical narrative: None at time of vaccination. Pt died 3-30-13 per family report. No known connection to vaccine administration.
Age: 36.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Feeling hot, Lymphadenopathy, Pain, Swelling
Clinical narrative: Throbbing, swelling, redness, warmth, swelling in lymph glands under arm and in neck. Antibiotic and steroid allergy med cool compress.
Age: 37.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Erythema, Feeling hot, Nausea, Swelling, Vomiting
Clinical narrative: Pt reported swelling/redness and "hot feeling" after injection in (L) arm was given. Was taken to local ER - tx with antihistamine, ice pack, PHENERGAN for N/V. Followed up with PCP and reports given cortisone injection and muscle relaxer.
Age: 0.36
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV1
Symptoms: Abnormal behaviour, Gaze palsy, Lethargy, Pyrexia, Staring
Clinical narrative: Lethargic, spiked 104.4 fever that lasted exactly 24 hrs from admin of vaccines. Eyes rolling back thru out 24 hr period, starring off. Behavioral changes - abnormal.
Age: 14.0
Sex: M
Vaccine: HEPA, HPV4
Symptoms: Dizziness, Fall, Headache, Injury, Loss of consciousness
Clinical narrative: After receiving HPV fell off exam table, with trauma frontal head and knees. Patient was fasting. LOC lasted few seconds. Accuchek 97, B/P 92/58. C/O mild headache w/o dizziness. Parent declined ER. Alert and oriented at discharge.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Erythema, Local swelling, Pruritus
Clinical narrative: Pts. upper arm was red and swollen. Arm itchy.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Rash
Clinical narrative: Large rash MD diagnosed cellulitis.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Feeling hot, Pruritus, Swelling
Clinical narrative: Swelling, erythema, warmth, itching. Supportive care, Benadryl PRN.
Age: 14.0
Sex: M
Vaccine: HPV4
Symptoms: Fall, Loss of consciousness, Tension
Clinical narrative: After receiving 3rd HPV vaccine, patient fell from examining table, lost consciousness, become tense for one minute, regained consciousness. Patient has known seizure disorder.