chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: This spontaneous report as received from a physician via a company field representative refers to a 14 year old female patient. On 22-JUL-2014 the patient was vaccinated with the first dose of GARDASIL, injection, (dose, frequency, route, lot # and expired date were not reported). Concomitant therapy was not reported. After injection on 22-JUL-2014, while having blood drawn, the patient fainted. The patient sought medical attention by being in doctor's office. The patient had to be given oxygen. None lab diagnostics studies were performed. The therapy with GARDASIL was not discontinued. The patient had fully recovered on 22-JUL-2014. The reporter considered the event to be medical significant because the patient needed to be given oxygen. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Electrocardiogram, Loss of consciousness, Syncope, Tremor
Clinical narrative: Right after vaccine patient developed syncope, tremors, brief LOC recovered well, was sent to ER r/o seizures.
Age: 0.2
Sex: U
Vaccine: RV5
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 2 month old patient of unknown gender. Medical history and concurrent conditions were not reported. On 25-JUL-2014, the patient was vaccinated with an expired ROTATEQ, oral, lot#J003465, expiration date 08-JUL-2014. Dose were not reported. No co-suspect and concomitant therapies were reported. No adverse affects reported. Additional information is not expected (no allowed to contact physician).
Age: 82.0
Sex: M
Vaccine: PPV
Symptoms: Generalised oedema, Localised oedema, Skin irritation
Clinical narrative: Edema, generalized; localized edema; skin irritation.
Age: 35.0
Sex: M
Vaccine: TDAP
Symptoms: Dizziness, Immediate post-injection reaction, Loss of consciousness, Syncope
Clinical narrative: Patient became dizzy while receiving vaccination. He fainted/passed out briefly and the paramedics were called. When they arrived patient was awake and conscious and said he didn't need further help, that this reaction was "normal" for him.
Age: 30.0
Sex: M
Vaccine: PPV
Symptoms: Skin irritation
Clinical narrative: Skin irritation.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Paraesthesia, Vision blurred
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. This report was reported to the pharmacist by the patient's husband. "About 2 weeks ago", on approximately 03-JUL-2014 the patient was vaccinated with ZOSTAVAX (dose and lot # not reported), subcutaneously. "Shortly after" the vaccination, in July 2014, the patient developed rash at the injection site, blurred vision and a tingling sensation in the hands and arms. No treatment was given. Lab tests were unspecified by the reporter. After a few days, in July 2014, the rash went away but the blurred vision and tingling were still present. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Arthralgia, Blood test, Injection site pain, Injection site swelling, Musculoskeletal stiffness
Clinical narrative: This spontaneous report as reported by a medical assistant refers to a 65 year old female patient with hypertension and high cholesterol. The patient was hospitalized and had a total knee replacement on June 2014. The patient's drug reaction/allergies included: codeine, monosodium glutamate (MSG), oxycodone, aspirin and thiopental sodium (manufacturer unknown)(MARRS 1407USA013369). On 11-JUN-2014, the patient was administered the first dose of PNEUMOVAX injection (dose, route, lot number and expiration date not reported) upon discharged from the hospital after a knee replacement. On 25-JUN-2014, the patient was seen in the office for her annual physical, inadvertently, the patient was administered a second dose of PNEUMOVAX 0.5 ml, intramuscular on left arm (lot number J008799 exp. 19-APR-2015) on that date because the office was not aware of the immunization at the hospital. Concomitant therapies included Lisinopril (manufacturer unknown), PRILOSEC and pravastatin sodium. On 26-JUN-2014, the patient called the office to report nausea, joint pain and stiffness, and pain with swelling at the injection site. She was evaluated in the office on 27-JUN-2014, and was advised to apply cool compresses to the injection site and to take unspecified anti-inflammatory medication. On 22-JUL-2014, the patient was seen in th office again due to persistent pain at the injection site. Unspecified blood work for inflammatory markers was drawn and results are pending. Outcome of nausea, joint pain and stiffness, and pain with swelling at the injection site was reported as not recovered at the time of the report. This is one of two reports from the same reporter. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Nausea
Clinical narrative: This spontaneous report as reported by a medical assistant refers to a 65 year old female patient with hypertension and high cholesterol. The patient was hospitalized and had a total knee replacement on June 2014. The patient's drug reaction/allergies included: codeine, monosodium glutamate (MSG), oxycodone, aspirin and thiopental sodium (manufacturer unknown)(MARRS 1407USA013369). On 11-JUN-2014, the patient was administered the first dose of PNEUMOVAX injection (dose, route, lot number and expiration date not reported) upon discharged from the hospital after a knee replacement. On 25-JUN-2014, the patient was seen in the office for her annual physical, inadvertently, the patient was administered a second dose of PNEUMOVAX 0.5 ml, intramuscular on left arm (lot number J008799 exp. 19-APR-2015) on that date because the office was not aware of the immunization at the hospital. Concomitant therapies included Lisinopril (manufacturer unknown), PRILOSEC and pravastatin sodium. On 26-JUN-2014, the patient called the office to report nausea, joint pain and stiffness, and pain with swelling at the injection site. She was evaluated in the office on 27-JUN-2014, and was advised to apply cool compresses to the injection site and to take unspecified anti-inflammatory medication. On 22-JUL-2014, the patient was seen in th office again due to persistent pain at the injection site. Unspecified blood work for inflammatory markers was drawn and results are pending. Outcome of nausea, joint pain and stiffness, and pain with swelling at the injection site was reported as not recovered at the time of the report. This is one of two reports from the same reporter. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Arthralgia, Blood test, Borrelia test, Headache, Incorrect dose administered
Clinical narrative: This spontaneous report as reported by a medical assistant refers to a 65 year old female patient with hypertension and high cholesterol. The patient was hospitalized and had a total knee replacement on June 2014. The patient's drug reaction/allergies included: codeine, monosodium glutamate (MSG), oxycodone, aspirin and thiopental sodium (manufacturer unknown)(MARRS 1407USA013369). On 11-JUN-2014, the patient was administered the first dose of PNEUMOVAX injection (dose, route, lot number and expiration date not reported) upon discharged from the hospital after a knee replacement. On 25-JUN-2014, the patient was seen in the office for her annual physical, inadvertently, the patient was administered a second dose of PNEUMOVAX 0.5 ml, intramuscular on left arm (lot number J008799 exp. 19-APR-2015) on that date because the office was not aware of the immunization at the hospital. Concomitant therapies included Lisinopril (manufacturer unknown), PRILOSEC and pravastatin sodium. On 26-JUN-2014, the patient called the office to report nausea, joint pain and stiffness, and pain with swelling at the injection site. She was evaluated in the office on 27-JUN-2014, and was advised to apply cool compresses to the injection site and to take unspecified anti-inflammatory medication. On 22-JUL-2014, the patient was seen in th office again due to persistent pain at the injection site. Unspecified blood work for inflammatory markers was drawn and results are pending. Outcome of nausea, joint pain and stiffness, and pain with swelling at the injection site was reported as not recovered at the time of the report. This is one of two reports from the same reporter. Additional information has been requested.
Age: 1.53
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Fatigue, Pyrexia
Clinical narrative: Following vaccinations child with high fevers and acting very tired.
Age: 72.0
Sex: M
Vaccine: FLU3, PPV, TDAP, VARZOS
Symptoms: Blister, Erythema, Local swelling, Pruritus
Clinical narrative: Patient had localized swelling on his right arm that was very red, itching, and blistered one day after receiving his vaccinations. He was instructed to use a cold compress, BENADRYL 25mg, and TYLENOL 500mg. He was also instructed to see a physician but refused.
Age: 11.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to an 8 month old female patient. On 08-APR-2000, the patient received the first dose of VARIVAX before she was 12 months old. On 19-MAY-2011, the patient was vaccinated with second dose VARIVAX. No adverse effects reported. The outcome of the patient received VARIVAX before she was 12 months old was unknown. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash, Rash pruritic, Rash vesicular
Clinical narrative: This spontaneous report was received from a pharmacist via patient's wife referring to a 65 year old male patient with hypertension who on 21-JUL-2014, was vaccinated with a dose of ZOSTAVAX, (lot # K000328, expiration date 06-MAR-2015), 0.65 ml, subcutaneous in the left arm.  Pharmacist stated client's wife called him today stating her husband had a rash that looks like chicken pox and started on 26-JUL-2014. The rash was itchy, and was on his legs, chest and hairline; about 15 to 20 bumps total. Pharmacist stated their are no fluid filled vesicles; and the bumps are scattered. Pharmacist stated treatment was Antihistamine and Hydrocortisone. The outcome of rash that looks like chicken pox was reported as not recovered/not resolved. No further details provided. Additional information is not expected.
Age: 5.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report was received from an unspecified reporter referring to a female patient of unknown age who on 15-MAY-2014, was vaccinated with a dose of M-M-R II, (HAS, lot# reported as J009885, expiration date 12-FEB-2015), in the left deltoid. These are their out of range temp logs and the vaccines that had been administered to the patient. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from an unspecified reporter referring to a female patient of unknown age who on 15-MAY-2014, was vaccinated with a dose of M-M-R II, (HAS, lot# reported as J009885, expiration date 12-FEB-2015), in the left deltoid. These are their out of range temp logs and the vaccines that had been administered to the patient. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 10 patients of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date the patients were vaccinated with ROTATEQ oral. Dose, lot number and expiration date were not reported. No co-suspect and concomitant therapies were reported. The nurse reported that the patients were administered improperly stored ROTATEQ over the last three months (in 2014). No adverse effects reported. This is one of several reports from the same source. Additional information is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. Pertinent medical history, drug reactions or allergies were unspecified. On 28-JUL-2014 the patient was vaccinated with VARIVAX (strength, route, dose, dose number, lot number and expiration date were not reported) instead of ZOSTAVAX. No adverse symptoms reported. None concomitant therapies were reported. The outcome of the event was unknown. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Diarrhoea, Vomiting
Clinical narrative: This spontaneous report was received from a healthcare worker referring to a patient of unknown age and gender who in July 2014 about 2 or 3 weeks ago was vaccinated with a dose of ROTATEQ (lot # and expiration date unknown), it was unknown how many in series of ROTATEQ that the patient received. On an unknown date, the patient had developed vomiting and diarrhea since receiving ROTATEQ. The outcome of vomiting and diarrhea was unknown. This is one of three reports from the same reporter source.  Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age. Since 21-JUL-2014, the unspecified patients were vaccinated with doses of VARIVAX (lot #, dose, frequency unspecified) that were exposed to a temperature excursion. No adverse effect had been observed or reported. Additional information has been requested.
Age: 40.0
Sex: F
Vaccine: PPV
Symptoms: Incorrect dose administered, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 40 year old female patient with Crohn's disease. On 28-APR-2014, the patient was vaccinated with the first dose of PNEUMOVAX23 injection (lot#, expiration date, dose, strength, route and indication not reported). On 24-JUL-2014, the patient was vaccinated with the second dose of PNEUMOVAX23 injection, in the arm (lot#, expiration date, dose, strength, route and indication not reported). The nurse practitioner reported that the patient developed pain and swelling of her arm where PNEUMOVAX was administered on 24-JUL-2014. The patient sought medical attention by office visit. At the time of reporting, the outcome of the events was not recovered. Additional information has been requested.
Age: 0.16
Sex: U
Vaccine: RV5
Symptoms: Diarrhoea, Ultrasound abdomen normal, Vomiting
Clinical narrative: This spontaneous report was received from a healthcare worker referring to a 2 month old twin patient of unknown gender who on 16-JUL-2014, was vaccinated with the 1st dose of ROTATEQ (lot 3 reported as K001198, expiration date 25-OCT-2015). On 16-JUL-2014, immediately after vaccination the patient developed vomiting and diarrhea, the mother clarified to the healthcare worker by stating spitting up more and up 6 episodes of diarrhea. The patient was seen in local emergency room on 21-JUL-2014. An ultrasound of abdomen was negative. The patient was treated and released on the same day. The outcome of vomiting and diarrhea was unknown. This is one of three reports from the same reporter source. Additional information has been requested.
Age: 0.17
Sex: U
Vaccine: RV5
Symptoms: Diarrhoea, Immediate post-injection reaction, Infantile spitting up, Vomiting
Clinical narrative: This spontaneous report was received from a healthcare worker referring to a 2 month old twin patient of unknown gender who on 16-JUL-2014, was vaccinated with 1st dose of ROTATEQ (lot # reported as K001198. expiration date 25-OCT-2015). On 16-JUL-2014, immediately after vaccination the patient developed vomiting and diarrhea. The mother clarified to healthcare worker by stating spitting up more and up 6 episodes of diarrhea. The outcome of vomiting and diarrhea was unknown. This is one of three reports from the same reporter source.  Additional information has been requested.
Sex: U
Vaccine: MMR
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 and gender. On 28-JUL-2014, the patient was vaccinated with a 0.5 ml expired dose of M-M-R II (lot # reported as J008882, expiration date 27-JUL-2014) subcutaneously. No adverse effects were reported. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: HEPA
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report was received from an unspecified reporter referring to a female patient of unknown age who on 05-JUN-2014 was vaccinated with a dose of VAQTA (lot # J000985, expiration date 20-AUG-2015) in the left deltoid. These were their out of range temp logs and the vaccines that had been administered to the patient. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative refers to a patient of unknown age and gender. No pertinent medical history or drug reactions/allergies were provided. On an unknown date, the patient was vaccinated with ZOSTAVAX vial (dose, route and lot number not provided). No co-suspect concomitant therapies were reported. On an unknown date, after receiving ZOSTAVAX, the patient developed an "outbreak of shingles". At the time of the report, the outcome of the event 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 nurse refers to a 10 patients of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date the patients were vaccinated with GARDASIL. Dose, route, lot number and expiration date were not reported. No co-suspect and concomitant therapies were reported. The nurse reported that the patients were administered improperly stored GARDASIL over the last three months (in 2014). No adverse effects reported. This is one of several reports from the same source. Additional information is not expected.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 10 patients of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date the patients were vaccinated with M-M-R II. Dose, route, lot number and expiration date were not reported. No co-suspect and concomitant therapies were reported. The nurse reported that the patients were administered improperly stored M-M-R II over the last three months (in 2014). No adverse effects reported. This is one of several reports from the same source. Additional information is not expected.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Paraesthesia, Rash
Clinical narrative: This spontaneous report as received from a pharmacist refers to approximately 66 year old female patient. The patients medical history included prior case of shingles. There was no drug reactions/allergies included. On 08-MAY-2014 the patient was vaccinated with ZOSTAVAX, 0.65 ml, one dose, subcutaneous (anatomical location, lot# not reported). No concomitant medications reported. The pharmacist reported that today (date of report that is 22-MAY-2014) came into the pharmacy with a rash on her forehead, experienced approximately on 20-MAY-2014 (calculated based on date adverse event first reported from that subtracted 2 day, because it was also reported as couple of day ago by the reporter). The patient also stated that the rash was also tingling, and therefore patient believed that it may be the shingles. The patient sought medical attention (contacted pharmacist). There was no treatment for the adverse event given. The outcome of rash was also tingling and rash on her forehead was reported as not recovered/not resolved. The outcome of patient believed that it may be the shingles was unknown. The patient was not hospitalized due to experience. The experience was not life threatening. There was no persistent or significant incapacity. No death. Intervention to prevent serious criteria was not required. Product quality complaint was not involved. Additional information has been requested. Follow up information has been received from a pharmacist refers to a 67 year old female patient. No concurrent conditions reported. On 08-MAY-2014 the patient was vaccinated with ZOSTAVAX lot # J007854 0.65ml, one dose, subcutaneously in the left arm. On an unknown date in May 2014 the patient developed rash at the site of injection. On an unknown date in May 2014 (1-2 weeks post vaccination) the patient experienced reoccurrence of herpes on her forehead. The patient did not have any illness at the time of vaccination. The patient had consulted her primary care physician. The outcome of the event reoccurrence of herpes on her forehead was unknown. The causality of reoccurrence of herpes on her forehead was unknown. The reporter considered the event reoccurrence of herpes on her forehead to be serious as medically significant. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Injection site rash, Paraesthesia, Rash
Clinical narrative: This spontaneous report as received from a pharmacist refers to approximately 66 year old female patient. The patients medical history included prior case of shingles. There was no drug reactions/allergies included. On 08-MAY-2014 the patient was vaccinated with ZOSTAVAX, 0.65 ml, one dose, subcutaneous (anatomical location, lot# not reported). No concomitant medications reported. The pharmacist reported that today (date of report that is 22-MAY-2014) came into the pharmacy with a rash on her forehead, experienced approximately on 20-MAY-2014 (calculated based on date adverse event first reported from that subtracted 2 day, because it was also reported as couple of day ago by the reporter). The patient also stated that the rash was also tingling, and therefore patient believed that it may be the shingles. The patient sought medical attention (contacted pharmacist). There was no treatment for the adverse event given. The outcome of rash was also tingling and rash on her forehead was reported as not recovered/not resolved. The outcome of patient believed that it may be the shingles was unknown. The patient was not hospitalized due to experience. The experience was not life threatening. There was no persistent or significant incapacity. No death. Intervention to prevent serious criteria was not required. Product quality complaint was not involved. Additional information has been requested. Follow up information has been received from a pharmacist refers to a 67 year old female patient. No concurrent conditions reported. On 08-MAY-2014 the patient was vaccinated with ZOSTAVAX lot # J007854 0.65ml, one dose, subcutaneously in the left arm. On an unknown date in May 2014 the patient developed rash at the site of injection. On an unknown date in May 2014 (1-2 weeks post vaccination) the patient experienced reoccurrence of herpes on her forehead. The patient did not have any illness at the time of vaccination. The patient had consulted her primary care physician. The outcome of the event reoccurrence of herpes on her forehead was unknown. The causality of reoccurrence of herpes on her forehead was unknown. The reporter considered the event reoccurrence of herpes on her forehead to be serious as medically significant. Additional information has been requested.
Sex: U
Vaccine: HPV4, MNQ, TDAP, HPV4
Symptoms: Rash
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender. In approximately June 2014 (reported as about 1 month ago) the patient was vaccinated with GARDASIL (dose, units and dose number were unknown). Pertinent medical history and concomitant medications were unspecified by the reporter. On an unknown date in 2014 the patient experienced anaphylactic reaction described as problems breathing, throat closing and hives. Treatment included BENADRL (route unspecified). The outcome of the event was unknown. The causality was unknown. No further information was provided. Additional information has been requested.
Sex: U
Vaccine: HPV4, MNQ, TDAP, HPV4
Symptoms: Anaphylactic reaction, Dyspnoea, Throat tightness, Urticaria
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender. In approximately June 2014 (reported as about 1 month ago) the patient was vaccinated with GARDASIL (dose, units and dose number were unknown). Pertinent medical history and concomitant medications were unspecified by the reporter. On an unknown date in 2014 the patient experienced anaphylactic reaction described as problems breathing, throat closing and hives. Treatment included BENADRL (route unspecified). The outcome of the event was unknown. The causality was unknown. No further information was provided. Additional information has been requested.
Age: 2.0
Sex: M
Vaccine: DTAPIPVHIB, MMR, PNC13, VARCEL, MMR, VARCEL
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site swelling
Clinical narrative: Immediate redness and swelling of all 4 sites especially R lower anterior thigh site injection. Pt has history of rashes due to allergies. Benadryl 0.25mg given orally.
Age: 57.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Arthralgia, Fatigue, Malaise
Clinical narrative: Malaise, fatigue, arthralgia x 48 hours. No treatment.
Age: 13.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Erythema, Injection site pain, Malaise, Pain, Pyrexia
Clinical narrative: History provided by the patient and mother. Patient is a 13-year-old male with no sickened PMH who presents with complaints of fever, left shoulder pain and rash. Patient received HPV vaccination one week ago on Monday (7/21/14) into the left deltoid and shoulder. He had some localized pain and soreness in her shoulder following injection. Over the weekend he began to feel ill with slight fever and developed a rash on Sunday. He began having red areas with small bumps mostly to left upper extremity. This continued to worsen with more areas of rash across the upper back and left side and abdomen. Patient has been taking Benadryl send ibuprofen for his rash and symptoms without significant improvement. Ibuprofen has helped with this shoulder soreness. Denies any other aggravating or alleviating factors. Denies similar symptoms previously.
Age: 13.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Rash generalised
Clinical narrative: History provided by the patient and mother. Patient is a 13-year-old male with no sickened PMH who presents with complaints of fever, left shoulder pain and rash. Patient received HPV vaccination one week ago on Monday (7/21/14) into the left deltoid and shoulder. He had some localized pain and soreness in her shoulder following injection. Over the weekend he began to feel ill with slight fever and developed a rash on Sunday. He began having red areas with small bumps mostly to left upper extremity. This continued to worsen with more areas of rash across the upper back and left side and abdomen. Patient has been taking Benadryl send ibuprofen for his rash and symptoms without significant improvement. Ibuprofen has helped with this shoulder soreness. Denies any other aggravating or alleviating factors. Denies similar symptoms previously.
Age: 13.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Herpes zoster, Immediate post-injection reaction, Leukopenia, Local reaction, Pain in extremity
Clinical narrative: History provided by the patient and mother. Patient is a 13-year-old male with no sickened PMH who presents with complaints of fever, left shoulder pain and rash. Patient received HPV vaccination one week ago on Monday (7/21/14) into the left deltoid and shoulder. He had some localized pain and soreness in her shoulder following injection. Over the weekend he began to feel ill with slight fever and developed a rash on Sunday. He began having red areas with small bumps mostly to left upper extremity. This continued to worsen with more areas of rash across the upper back and left side and abdomen. Patient has been taking Benadryl send ibuprofen for his rash and symptoms without significant improvement. Ibuprofen has helped with this shoulder soreness. Denies any other aggravating or alleviating factors. Denies similar symptoms previously.
Age: 13.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Pyrexia, Rash, Rash vesicular, Vaccination complication, White blood cell count decreased
Clinical narrative: History provided by the patient and mother. Patient is a 13-year-old male with no sickened PMH who presents with complaints of fever, left shoulder pain and rash. Patient received HPV vaccination one week ago on Monday (7/21/14) into the left deltoid and shoulder. He had some localized pain and soreness in her shoulder following injection. Over the weekend he began to feel ill with slight fever and developed a rash on Sunday. He began having red areas with small bumps mostly to left upper extremity. This continued to worsen with more areas of rash across the upper back and left side and abdomen. Patient has been taking Benadryl send ibuprofen for his rash and symptoms without significant improvement. Ibuprofen has helped with this shoulder soreness. Denies any other aggravating or alleviating factors. Denies similar symptoms previously.
Age: 5.0
Sex: F
Vaccine: MMR
Symptoms: Crying, Expired drug administered, Immediate post-injection reaction, Screaming
Clinical narrative: This spontaneous report as received from a healthcare worker (medical assistant) refers to a 5 year old female patient. Th patient had none pertinent medical history and none drug reactions and allergies. On 16-JUL-2014, the patient received expired dose of M-M-R II, 0.5 ml, subcutaneous (lot # H011907, expiration date: 03-JUL-2014). The healthcare worker reported that the patient received three shots all together including the M-M-R II at the same office visit. Two of the shots were unspecified (it was also reported that there was no concomitant medication). She stated that the patient was screaming and crying while receiving M-M-R II and the two other unspecified shots on 16-JUL-2014. There was no treatment given for adverse events and no lab diagnostics studies performed. The medical assistant reported that the patient stopped screaming and crying after she left the doctor's office at an unspecified time on 16-JUL-2014. The relatedness between screaming and crying and the vaccination with M-M-R I was unknown. The patient did not seek medical attention. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Pyrexia, Vomiting
Clinical narrative: Fever 103, 12 hours after MMR-V and KINRIX and vomiting.
Age: 0.4
Sex: U
Vaccine: DTAPIPVHIB, HIBV
Symptoms: CSF culture positive, Haemophilus test positive, Meningitis haemophilus
Clinical narrative: This case was reported by a physician via Merck and described the occurrence of HIB Meningitis in a 5-month-old subject of unspecified gender who was vaccinated with (non-GSK) PENTACEL, (Sanofi Pasteur MSD), HIB. The subject's medical history included intraventricular hemorrhage and premature birth. The subject was one of twins born prematurely at 29 weeks gestation. Concurrent medical conditions included gastroesophageal reflux disease. Concurrent medications included ZANTAC. In 2013 the subject received 1st dose of PENTACEL (unknown details), 2nd dose of HIB vaccine (unknown details). In 2013, within months of vaccination with HIB vaccine and PENTACEL, the subject experienced HIB Meningitis and possible vaccination failure. It is unknown whether this case meets GSK criteria of vaccination failure. The subject was hospitalised. Relevant test results included a CSF culture that was HIB positive by latex agglutination in 2013. At the time of reporting the events were improved.
Age: 10.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Gave ADACEL to 10 yr 3 mo old.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 67 year old male patient. On an unknown date in 2009 the patient was vaccinated with the first dose of ZOSTAVAX (lot #, expiration date, dose, route not reported). On 02-JUL-2014 the patient was vaccinated with second doe of ZOSTAVAX (lot #, expiration date not provided) 0.65 ml, subcutaneous in the back of left upper arm. No adverse effects were reported. The reporter stated that after the patient got home, he called her to tell that he had had a ZOSTAVAX vaccination in 2009. Additional information is not expected.
Sex: U
Vaccine: VARCEL
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. No patients' demographics were provided. It was reported that on 01-JUL-2014 an unknown number of patients were administered (Oka/Merck) VARIVAX after it reached a temperature of 11F for 45 minutes. The vaccines were administered subcutaneously, sites of administrations, doses, lot# and expiration dates not reported. The temperature excursion was supported. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a consumer refers to a patient of unknown age and gender (consumer's friend's physician). On an unknown date, the patient was vaccinated with ZOSTAVAX (dose, route of administration, lot # and expiration date were not provided). The consumer reported that, on an unknown date, the patient (consumer's friend's physician, unspecified) was diagnosed with shingles after receiving ZOSTAVAX. The outcome of the event was unknown. The relatedness between the shingles and the vaccination with ZOSTAVAX was unknown. Additional information is not expected because the reporter declined to answering any further questions.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from 2 healthcare workers refers to unspecified amount of patients of unknown age and gender. On unspecified date between 10-MAY-2014 and 23-JUN-2014, the patients were vaccinated with GARDASIL injection (lot # H020901, expiration date 05-JUL-2015), 0.5ml, intramuscularly, that underwent a temperature excursion. No adverse effect reported. This is one of the several reports from the same source. Additional information has been requested.
Age: 52.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: 7x6 cm area of swelling and erythema over site of injection (R) upper arm beg day after vaccination. Rx KEFLEX 500 mg Q6 hr x 7 dy with warm compress.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The nurse reported that one dose of (Oka/Merck) VARIVAX 1350U, 0.5ml, subcutaneous (lot # and expiration date were not provided) that was exposed to -12C for 2 hours, was administered, on 14-JUL-2014, to an unspecified patient. No adverse effect was reported. This is one of several cases from the same source. Additional information has been requested.
Age: 0.85
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Urticaria
Clinical narrative: Child was given the following vaccines; PEDIARIX, Hib, PCV-13 at 9:16 am on 7-28-14- left w/o adverse reaction but when child got home 1/2 hr later developed hives on body and was brought back to doctors office. Dr was made aware and given BENADRYL at 9:37 am.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The nurse reported that one dose of PROQUAD (dose, route of administration, lot # and expiration date were not provided) that was exposed to -12C for 2 hours, was administered, on 14-JUL-2014, to an unspecified patient. No adverse effect was reported. This is one several cases from the same source. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Immediate post-injection reaction, Loss of consciousness
Clinical narrative: Immediately after administration of vaccine, patient lost consiousness briefly.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister
Clinical narrative: Pt had shingle vaccine 7/28 at 1 pm, later that evening, she developed a blister Lt hand. No itchiness or pain; just tender on palpation. NO fever, chills, feeling fine, URI sx's. Pt had h/o chicken pox when she was younger.
Age: 15.0
Sex: M
Vaccine: MMR
Symptoms: Contusion, Full blood count, Haemorrhage, Immunoglobulin therapy, Petechiae
Clinical narrative: No signs or symptoms noticed until 7/24/20014 but mom wanted platelets checked before leaving for a trip abroad. Platelets on 7/22/14 were 12k without any bruising/petechiae/bleeds. He developed a bruise on 7/24/14 and platelets were 2k. He was then sent to Hospital and received IVIG x 1. CBCs to be followed weekly.
Age: 15.0
Sex: M
Vaccine: MMR
Symptoms: Platelet count decreased
Clinical narrative: No signs or symptoms noticed until 7/24/20014 but mom wanted platelets checked before leaving for a trip abroad. Platelets on 7/22/14 were 12k without any bruising/petechiae/bleeds. He developed a bruise on 7/24/14 and platelets were 2k. He was then sent to Hospital and received IVIG x 1. CBCs to be followed weekly.
Age: 35.0
Sex: F
Vaccine: MMR
Symptoms: Central nervous system lesion, Demyelination, Lumbar puncture abnormal, Nuclear magnetic resonance imaging brain abnormal, Paraesthesia
Clinical narrative: Approximately 1 week following vaccine felt sensation of walking on glass and tingling in fingers. After 2nd MMR on 4/8/14 developed excess salivation and vertigo. Seen in ED on 4/17/14 and referred to neurologist. MRI of brain on 5/15/14 reveled new demylinating lesion. Treated with IV Solumedrol on 5/27/14 for 3 days and is taking Neurontin and Cymbalta.
Age: 35.0
Sex: F
Vaccine: MMR
Symptoms: Salivary hypersecretion, Vertigo
Clinical narrative: Approximately 1 week following vaccine felt sensation of walking on glass and tingling in fingers. After 2nd MMR on 4/8/14 developed excess salivation and vertigo. Seen in ED on 4/17/14 and referred to neurologist. MRI of brain on 5/15/14 reveled new demylinating lesion. Treated with IV Solumedrol on 5/27/14 for 3 days and is taking Neurontin and Cymbalta.
Age: 32.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Dyspnoea, Purulence, Rash generalised
Clinical narrative: Labored breathing, broke out in pus filled bumps all over my body (not just in localized area like vaccine should caused).
Age: 9.0
Sex: F
Vaccine: FLU3
Symptoms: Corrective lens user, Lumbar puncture, Multiple sclerosis, Nuclear magnetic resonance imaging abnormal, Vision blurred
Clinical narrative: My daughter was having difficulty seeing the board at school the week of 09/09/2013. On 09/17/2013 my daughter had an eye exam revealing a change in her eyes. The doctor mentioned seeing a specialist for Glaucoma. She saw a specialist, fitted for glasses. In the month of May 2014 my daughter could not see the board again at school. She was fitted with a new prescription for glasses again on 06/10/2014. On 07/07/2014 diagnosed at Hospital with Multiple Sclerosis.
Age: 9.0
Sex: F
Vaccine: FLU3
Symptoms: Visual impairment
Clinical narrative: My daughter was having difficulty seeing the board at school the week of 09/09/2013. On 09/17/2013 my daughter had an eye exam revealing a change in her eyes. The doctor mentioned seeing a specialist for Glaucoma. She saw a specialist, fitted for glasses. In the month of May 2014 my daughter could not see the board again at school. She was fitted with a new prescription for glasses again on 06/10/2014. On 07/07/2014 diagnosed at Hospital with Multiple Sclerosis.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date, an unspecified amount of patients were administered PROQUAD (dose, route, lot # and expiration date were not reported) that underwent a temperature excursion. No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 08-JUL-2014 the patient was vaccinated with expired dose of M-M-R II (albumin status HSA, vaccine vial, subcutaneous, lot#H011898, expiry date: 25-JUN-2014). No adverse effects was reported. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Immediate post-injection reaction, Injection site warmth, Nail bed infection fungal, Nail disorder
Clinical narrative: This spontaneous report as received from a 61 year old female patient with no pertinent medical history refers to herself. The patient developed fever after receiving an unspecified tetanus shot (dates not specified). On 15-OCT-2013, reported as around 15-OCT-2013, the patient was vaccinated with a dose of ZOSTAVAX, standard dose, route reported as injection (lot number was not specified). Concomitant medications included unspecified vitamins. On 15-OCT-2013, reported as immediately after receiving the vaccine, the patient felt heat in her arm where the vaccine ws administered and she could see where the vaccine was traveling under her skin from the injection site down to her elbow. About 4 hours after receiving the vaccine, she broke out blisters on her thumb with progressed until her whole thumb has become covered in blisters. The patient stated that at the time of report her thumb nail looked as though it was rotted away and a new nail had grown but looked somewhat deformed and might be growing fungus in the nail bed near the cuticle (dates not specified). The patient also explained that on an unspecified date in 2014, reported as within the last 3-4 months, she had also developed blisters in the palm of her hand and her thumb area had become very sensitive to heat. The events were treated with unspecified salves and creams. The patient sought medical attention via office visits in November 2013 and January 2014. There were  no lab diagnostics studies performed. The outcome of the events was reported as not recovered. The relatedness between the events and ZOSTAVAX was not reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Temperature intolerance
Clinical narrative: This spontaneous report as received from a 61 year old female patient with no pertinent medical history refers to herself. The patient developed fever after receiving an unspecified tetanus shot (dates not specified). On 15-OCT-2013, reported as around 15-OCT-2013, the patient was vaccinated with a dose of ZOSTAVAX, standard dose, route reported as injection (lot number was not specified). Concomitant medications included unspecified vitamins. On 15-OCT-2013, reported as immediately after receiving the vaccine, the patient felt heat in her arm where the vaccine ws administered and she could see where the vaccine was traveling under her skin from the injection site down to her elbow. About 4 hours after receiving the vaccine, she broke out blisters on her thumb with progressed until her whole thumb has become covered in blisters. The patient stated that at the time of report her thumb nail looked as though it was rotted away and a new nail had grown but looked somewhat deformed and might be growing fungus in the nail bed near the cuticle (dates not specified). The patient also explained that on an unspecified date in 2014, reported as within the last 3-4 months, she had also developed blisters in the palm of her hand and her thumb area had become very sensitive to heat. The events were treated with unspecified salves and creams. The patient sought medical attention via office visits in November 2013 and January 2014. There were  no lab diagnostics studies performed. The outcome of the events was reported as not recovered. The relatedness between the events and ZOSTAVAX was not reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a consumer refers to a female patient of unknown age. Medical history and concurrent conditions were not specified. In October 2013 (exact date not specified) the patient was vaccinated with a dose of ZOSTAVAX (dose number, lot number and route were not reported). Concomitant medications were not specified. On an unknown date, the patient experienced shingles in her toe. The outcome of shingles in her toe was unknown. The relatedness between the shingles in her toe and ZOSTAVAX was not reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Ophthalmic herpes zoster
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a 67 year old female patient. The physician reported that, on an unknown date (reported as in the past), the patient received ZOSTAVAZ (dose, route of administration, lot # and expiration date not provided) and, on 11-JUL-2014, developed ophthalmic zoster, zoster near the eye. The physician prescribed to the patient unspecified antiviral therapy and referred her to an unspecified ophthalmologist. The outcome of ophthalmic zoster was unknown. The relatedness between the event and the therapy with ZOSTAVAX was unknown. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from 2 healthcare workers refers to unspecified amount of patients of unknown age and gender. On unspecified date between 10-MAY-2014 and 23-JUN-2014, the patients were vaccinated with 0.5ml, intramuscularly VAQTA injection (lot # J005010, expiration date 23-OCT-2015) that underwent a temperature excursion, 0.5 ml, intramuscularly. No adverse effect reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from 2 healthcare workers refers to unspecified amounts of patients of unknown age and gender. On unspecified date between 10-MAY-2014 and 23-JUN-2014, the patients were vaccinated with RECOMBIVAX (lot # J004700, expiration date 26-NOV-2015) that underwent a temperature excursion, 0.5ml, intramuscularly. No adverse effect reported. This is one of several reports from the same source. Additional information has been requested.