chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 38.0
Sex: M
Vaccine: FLU3
Symptoms: Anaphylactic reaction
Clinical narrative: Anaphylaxis.
Age: 1.38
Sex: M
Vaccine: DT, DTAP, DTP, HIBV
Symptoms: Conjunctivitis, Cough, Decreased appetite, Eye discharge, Influenza
Clinical narrative: Fever, lack of appetite, irritable, cough, runny eyes & nose. Took to urgent care diagnosed with Hib - conjunctivitis & otitis media. Had 105.1 fever and has lowered to 101.1.
Age: 1.38
Sex: M
Vaccine: DT, DTAP, DTP, HIBV
Symptoms: Irritability, Otitis media, Pyrexia, Rhinorrhoea
Clinical narrative: Fever, lack of appetite, irritable, cough, runny eyes & nose. Took to urgent care diagnosed with Hib - conjunctivitis & otitis media. Had 105.1 fever and has lowered to 101.1.
Age: 15.0
Sex: M
Vaccine: FLUX
Symptoms: Abdominal pain, Asthenia, Pyrexia, Vomiting
Clinical narrative: Violent vomiting, weakness, fever (measured at 7:30 PM - 100.7), pain in abdomen, weak, not able to sleep. called doctor, gave Tylenol.   Symptoms continue into night (*5:00AM - 100.3 fever), still feels like throwing up, still has pain in abdomen.  Weak.  Doctor stated they felt no relation to shot, but son has not been sick in 4 years, healthy no sickness prior to shot.
Age: 6.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Feeling hot
Clinical narrative: Pt felt faint, dizzy, hot shortly after being vaccinated. Had pt sit in chair where he rested, received cold compresses and was manually fanned. Pt recovered after approximately 30 min. Was given vitamin H2O to drink.
Age: 11.0
Sex: M
Vaccine: FLU3
Symptoms: Syncope
Clinical narrative: Pt collapsed while in the arms of his mother. Pt was laid down on the ground gently (protecting the head). Was given cold compresses and fanned down. When he felt better we assisted him to a seat to rest. Was given vitamin H2O to drink. Recovered after approximately 30 minutes.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Unevaluable event
Clinical narrative: Information has been received from a literature article title as stated above concerning a 14 year old female patient developed uveitis, following administration of GARDASIL. A total of 24 cases of uveitis occurred following administration of GARDASIL; the gender in all cases was female. The median age was 17 (range 12-29). The median time from vaccination to onset of ADRs was 30 days (range 0-476 days); time to onset was unknown in 1 case; the time to onset in this case was of 56 days from vaccination. There was one reported rechallenge of the GARDASIL vaccine. In 13 of the 24 cases other ocular side effects were noted including 3 case reports of papillitis, 2 case reports of retinitis and 1 case report of apailledema. Systemic side effects were noted in 9 of the 24 cases and included 3 cases of arthralgia. In 2 case reports multiple vaccines were administered simultaneously. According to World Health Organization Causality Assessment Guide of Suspected Adverse Reactions, the relationship between human papilloma virus vaccination and uveitis was "possible". Causality assessments are based on the time relationship of drug administration, uveitis development and rechallenge data. This is one of several reports from the same literature source. Additional information has been requested. A copy of the published article is attached as further documentation of the patient's experience.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Retinitis, Uveitis
Clinical narrative: Information has been received from a literature article title as stated above concerning a 11 year old female patient developed uveitis and retinitis, following administration of GARDASIL. A total of 24 cases of uveitis occurred following administration of GARDASIL; the gender in all cases was female. The median age was 17 (range 12-29). The median time from vaccination to onset of ADRs was 30 days (range 0-476 days); time to onset was unknown in this case. There was one reported rechallenge of the GARDASIL vaccine. In 13 of the 24 cases other ocular side effects were noted including 3 case reports of papillitis, 2 case reports of retinitis and 1 case report of apailledema. Systemic side effects were noted in 9 of the 24 cases and included 3 cases of arthralgia. In 2 case reports multiple vaccines were administered simultaneously. According to World Health Organization Causality Assessment Guide of Suspected Adverse Reactions, the relationship between human papilloma virus vaccination and uveitis was "possible". Causality assessments are based on the time relationship of drug administration, uveitis development and rechallenge data. This is one of several reports from the same literature source. Additional information has been requested. A copy of the published article is attached as further documentation of the patients experience.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Anaphylactic reaction, Dyspnoea, Influenza
Clinical narrative: Pt reported shortness of breath about 1 hour post vaccine and I instructed her to go immediately to ER. Upon follow-up, pt informed me she suffered anaphylaxis and has the flu.
Age: 74.0
Sex: F
Vaccine: FLU4
Symptoms: Mobility decreased, Muscular weakness, Pain, Pain in extremity
Clinical narrative: Pt states arm sore when using, cannot lift anything, cannot move arm above head or behind back, pain when using her walker, (in arm vaccinated) no strength in arm.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report as received from a nurse refers to 4 patients of unknown age. On unknown dates during the past 6 months the 4 patients was vaccinated with a dose of 0.5ml PNEUMOVAX23 (lot #, expiration date unspecified) intramuscular. On unknown dates the patients developed injection site reactions of redness and swelling. All patients recovered within 4 days from the onset of symptoms. Nurse was not sure whether or not these patients received PNEUMOVAX23 in the past. The patients sought medical attention via office visit. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema
Clinical narrative: This spontaneous report as received from a consumer refers to a 13 year old female patient (the report's daughter) with no pertinent medical history or drug reactions. On 14-OCT-2013 the patient was vaccinated with the second dose of GARDASIL (lot # J007354, expiration date: 20-FEB-2016), dose and route not reproted for "prevent HPV". The reporter was unable to provide the date of the first dose. No concomitant medication was reported. The reporter reported that her daughter developed redness at the injection site after receiving GARDASIL on 14-OCT-2013 that was involved in a recent recall of the product. No treatment was given to the adverse event. No lab diagnostics studies were performed. On an unknown date, the patient was recovered from the adverse event. The patient had not sought medical attention. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age. The reporter stated that the patient was administered the first dose in GARDASIL (0.5 ml, intramuscular, lot# not provided) series on an unspecified date, second dose in November 2013 and the third dose in series on an unspecified date in January 2014. Medical assistant was called back to obtain demographic information and clarified that patient was administered the second dose (0.5 ml, intramuscular, lot# not provided) on 15-NOV-2013 and the third dose in GARDASIL series on 10-JAN-2014 (0.5 ml, intramuscular, lot# not provided). No adverse effects were reported. It was unknown if the patient had sought medical attention. The outcome was unknown. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Discomfort
Clinical narrative: This spontaneous report as received from a medical assistant refers to a group of unspecified patients. No medical history or concurrent conditions were reported. On unknown dates the patients were vaccinated with GARDASIL. No concomitant medication was reported. The reporter stated that some unspecified patients have experienced discomfort with administration of GARDASIL on unspecified dates. The outcome of the discomfort was unknown. No further information was provided. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from the registered nurse on 02-JAN-2014. It was reported that GARDASIL were stored in improper temperature and were administered to overall number of 132 patients. This report refers to one of the patients involved: a patient of unspecified age and gender, who had administered dose of GARDASIL on 06-AUG-2013 (lot # H021608, Expiration Date: 13-AUG-2015). No adverse event was reported. This is one of the reports from the same source. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a physician assistant refers to a patient of unknown age and gender. On approximately January 2013 (also reported as over a year) the patient was vaccinated with 2 doses of GARDASIL (lot number and expiry date was unknown) possibly off schedule. No concomitant medications were reported. It was reported that the patient had visited the doctor for a third dose on 14-JAN-2014. No adverse events were reported. No product quality issue was reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse on 02-JAN-2014. It was reported that GARDASIL vaccines were stored in improper temperatures and were administered to overall number of 132 patients. This report refers to one of the patients involved: a patient of unspecified age and gender, who was  administered dose of GARDASIL on 11-JUN-2013 lot # reported as 1495AA expiration date: 22-AUG-2015. No adverse event was reported. This is one of the report from the same source. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from the registered nurse on 02-JAN-2014. It was reported that GARDASIL vaccines were stored in improper temperatures and were administered to overall number of 132 patients. This report refers to one of the patients involved: a patient of unspecified age and gender, who had administered dose of GARDASIL on 12-AUG-2013 (lot # H011350, Expiration Date: 21-FEB-2015). No adverse event was reported. This is one of the reports from the same source. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Unevaluable event
Clinical narrative: Information has been received from the nurse on 02-JAN-2014. It was reported that GARDASIL was administered to overall number of 132 patients. This report refers to one of the patients involved: a patient of unspecified age and gender, who had administered dose of GARDASIL on 28-FEB-2013 (lot # H011350, Expiration Date: 21-FEB-2015). This is one of the report from the same source, linked reports. Additional information is not expected.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Burning sensation, Herpes zoster, Injection site rash, Pruritus
Clinical narrative: This spontaneous report as received from a currently 69 year old male consumer refers to himself. In December 2011, the patient was vaccinated with a dose of ZOSTAVAX (lot #, dose and route not provided) vial, single administration dose injection. Concomitant therapies included hydrocortisone cream. In 2012, a "few months" following administration, he began breaking out in a rash around the injection site. The rash grew in size and remained for nearly three months, also involving his hips and legs, beginning on the back of one leg, then "traveling to the other". The patient described the rash as "feeling like rough sandpaper, very itchy with small bumps that felt like they were bursting". Three months passed and the rash subsided. A physician confirmed the remarks on his skin as being evidence of the shingles virus. The patient added that "about two months ago, during 2013, he felt burning and heat on his left forearm. One day later, he began breaking out again in an intermittent rash which involved his arm, sides, hips and shoulders, in the form of small, burning and itchy patches. He experienced scarring of the skin and tiny pustules that burst. He noted that the rash often changed in size; it could range from "the size of a 50 cent piece to as long as 6-8 on his leg. The patient sought medical attention by an appointment with the physician. It was given over the counter ointment as treatment for the event. At the time of the report, the patient had not recovered. The therapy was not reintroduced. Additional information is not expected.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash, Rash pustular, Scar
Clinical narrative: This spontaneous report as received from a currently 69 year old male consumer refers to himself. In December 2011, the patient was vaccinated with a dose of ZOSTAVAX (lot #, dose and route not provided) vial, single administration dose injection. Concomitant therapies included hydrocortisone cream. In 2012, a "few months" following administration, he began breaking out in a rash around the injection site. The rash grew in size and remained for nearly three months, also involving his hips and legs, beginning on the back of one leg, then "traveling to the other". The patient described the rash as "feeling like rough sandpaper, very itchy with small bumps that felt like they were bursting". Three months passed and the rash subsided. A physician confirmed the remarks on his skin as being evidence of the shingles virus. The patient added that "about two months ago, during 2013, he felt burning and heat on his left forearm. One day later, he began breaking out again in an intermittent rash which involved his arm, sides, hips and shoulders, in the form of small, burning and itchy patches. He experienced scarring of the skin and tiny pustules that burst. He noted that the rash often changed in size; it could range from "the size of a 50 cent piece to as long as 6-8 on his leg. The patient sought medical attention by an appointment with the physician. It was given over the counter ointment as treatment for the event. At the time of the report, the patient had not recovered. The therapy was not reintroduced. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from the registered nurse on 02-JAN-2014. It was reported that GARDIS vaccines were stored in improper temperatures were administered to overall number of 132 patients. This report refers to one of the patients involved, a patient of unspecified age and gender, who had administered dose of GARDASIL on 05-AUG-2013 (lot # H011350, Expiration Date: 21-FEB-2015). No adverse event was reported. This is one of the 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 health worker refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with a dose of MMR II (lot # H009578, expire date 07-May-2014) (dose, strength, route and indication not reported). The healthcare worker (immunization official) reported that over last 4 months, MMR II doses were stored in a freezer in a plastic container, out of original carton and were exposed to light each time freezer door was opened. One dose of MMR II that might have been exposed to excessive light was administered to unspecified patient. No adverse effects reported. It was unspecified if the patient seek medical attention. 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 registered nurse refers to a female patient of unknown age. On an unknown date 3 to 4 yeas ago the patient was vaccinated with GARDASIL dose 1 and 2. On an unknown date the patient and her sister (see linked case 1401USA005969) were about to receive their 3rd dose of GARDASIL and had received their 2nd dose of GARDASIL 3 to 4 years ago. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from the registered nurse on 02-JAN-2014. It was reported that GARDSIL vaccines were stored improper temperatures and were administered to overall number of 132 patients. This report refers to one of the patients involved: a patient of unspecified age and gender, who had administered dose of GARDSIL on 09-AUG-2013 (lot # H011350, Expiration Date: 21-FEB-2015). No adverse event was reproted. This is one of the reports from the same source. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from the registered nurse on 02-JAN-2014. It was reported that GARDASIL vaccines were stored in improper temperatures were administered to overall number of 132 patients. This report refers to one of the patients involved: a patient of unspecified age and gender, who had administered dose of GARDASIL on 06-AUG-2013 (lot # H021608, Expiration Date: 13-AUG-2015). No adverse event was reported. This is one of the reports from the same source. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a female patient of unknown age. On an unknown date 3 to 4 years ago the patient was vaccinated with GARDASIL dose 1 and 2. On an unknown date the patient and her sister (see linked case 1401USA006722) were about to receive their 3rd dose of GARDASIL and had received their 2nd dose of GARDASIL 3 to 4 years ago. No adverse effect was reported. Additional information has been requested.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Blood pressure abnormal, Feeling abnormal, Malaise, Orthostatic hypertension
Clinical narrative: Case number PHEH2014US000829, is an initial spontaneous report received from the consumer on 08 Jan 2014. This report refers to a 49-year-old female patient. Her medical history included multiple sclerosis. Her concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 13391P) intramuscularly on 26 Oct 2013. On the same day after vaccination, she was feeling sick and saw her physician on 28 Oct 2013, who immediately hospitalized her for the next four days. During hospitalization, she received fluids and 100 milliequivalents of potassium. It was reported that no diagnosis was made during this hospitalization. After she was discharged, she was still feeling so bad. She visited her physician again on 11 Nov 2013 and was hospitalized on 12 Nov 2013 where she stayed until she was discharged on 16 Nov 2013. During this hospitalization, she was diagnosed with orthostatic hypotension and was treated with potassium and magnesium to raise her blood pressure to normal. The event outcome and causality was not reported.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Conjunctival hyperaemia, Uveitis
Clinical narrative: Information has been received from a literature article concerning a 14 year old female patient developed uveitis and conjunctival hyperemia, following administration of GARDASIL. The patient had as a pre-existing conditions tubulointerstitial nephritis Wegener's. A total of 24 cases of uveitis occurred following administration of GARDASIL; the gender in all cases was female. The median age was 17 (range 12-29). The median time from vaccination to onset of ADRs was 30 days (range 0-476 days); time to onset was unknown in 1 case; the time to onset in this case was of 7 days from vaccination. There was one reported rechallenge of the GARDASIL vaccine. In 13 of the 24 cases other ocular side effects were noted including 3 case reports of papillitis, 2 case reports of retinitis and 1 case report of papilledema. Systemic side effects were noted in 9 of the 24 cases and included 3 cases of arthralgia. In 2 case reports multiple vaccines were administered simultaneously. There was insufficient data in the case reports to determine whether co-morbid Wegener's granulomatosis and tubulointerstitial uveitis were excluded as the cause of uveitis in this case. According to the World Health Organization Causality Assessment Guide of Suspected Adverse Reactions, the relationship between human papilloma virus vaccination and uveitis was "possible". Causality assessments are based on the time relationship of drug administration, uveitis development and rechallenge data. This is one of several reports from the same literature source. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Conjunctivitis, Keratitis, Uveitis
Clinical narrative: Information has been received from a literature article concerning a 16 year old female patient developed uveitis, keratitis and conjunctivitis following administration of GARDASIL. A total of 24 cases of uveitis occurred following administration of GARDASIL; the gender in all cases was female. The median age was 17 (range 12 - 29). The median time from vaccination to onset of ADR's was 30 days (range 0 - 476 days); time to onset was unknown in this case. There was one reported rechallenge of the GARDASIL vaccine. In 13 of the 24 cases other ocular side effects were noted including 3 case reports of papillitis, 2 case reports of retinitis and 1 case report of papilledema. Systemic side effects were noted in 9 of the 24 cases and included 3 cases of arthralgia. In 2 case reports multiple vaccines were administered simultaneously. According to World Health Organization Causality Assessment Guide of Suspected Adverse Reactions, the relationship between human papilloma virus vaccination and uveitis was "possible" Causality assessments are based on the time relationship of drug administration, uveitis development and rechallenge data. This is one of several reports from the same literature source. Additional information has been requested.
Sex: U
Vaccine: PPV
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 10-JAN-2014 the patient was vaccinated with a dose of PNEUMOVAX 23 (dose and route not provided) lot # 0709AE, which was expired on 04-JAN-2014. No adverse effects were reported. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Uveitis
Clinical narrative: Information has been received from a literature article title as stated above concerning a 13 year old female patient developed uveitis following administration of GARDASIL. A total of 24 cases of uveitis occurred following administration of GARDASIL; the gender in all cases was female. The median age was 17 (range 12-29). The median time from vaccination to onset of ADRs was 30 days (range 0-476 days); time to onset was unknown in 1 case; the time to onset in this case was 476 days from vaccination. There was one reported rechallenge of the GARDASIL vaccine. In 13 of the 24 cases other ocular side effects were noted including 3 case reports of papillitis, 2 case reports of retinitis and 1 case report of papilledema. Systemic side effects were noted in 9 of the 24 cases and included 3 cases of arthralgia. In 2 case reports multiple vaccines were administered simultaneously. According to World Health Organization Causality Assessment Guide of Suspected Adverse Reactions, the relationship between human papilloma virus vaccination and uveitis was "possible". Causality assessments are based on the time relationship of drug administration uveitis development and rechallenge data. This is one of several reports from the same literature source. Additional information has been requested. A copy of the published article is attached as further documentation of the patients experience.
Age: 27.0
Sex: F
Vaccine: HPV4
Symptoms: Uveitis
Clinical narrative: Information has been received from a literature article title as stated above concerning a 27 year old female patient developed uveitis following administration of GARDASIL. A total of 24 cases of uveitis occurred following administration of GARDASIL; the gender in all cases was female. The median age was 17 (range 12-29). The median time from vaccination to onset of ADRs was 30 days (range 0-476 days); time to onset was unknown in 1 case; the time to onset in this case was 3 days from vaccination. There was one reported rechallenge of the GARDASIL vaccine. In 13 of the 24 cases other ocular side effects were noted including 3 case reports of papillitis, 2 case reports of retinitis and 1 case report of papilledema. Systemic side effects were noted in 9 of the 24 cases and included 3 cases of arthralgia. In 2 case reports multiple vaccines were administered simultaneously. According to World Health Organization Causality Assessment Guide of Suspected Adverse Reactions, the relationship between human papilloma virus vaccination and uveitis was "possible". Causality assessments are based on the time relationship of drug administration uveitis development and rechallenge data. This is one of several reports from the same literature source. Additional information has been requested. A copy of the published article is attached as further documentation of the patients experience.
Age: 20.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Pain
Clinical narrative: Received IM flu vaccine, had local pain at time of injection, no swelling or erythema, now with ongoing local pain 2 months later.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Abdominal pain, Arthralgia, Autoimmune disorder, Cholecystectomy, Endoscopic ultrasound
Clinical narrative: C/O abd pain/nausea approx 2 wks after injection. Seen physician approx 1 mo after injection 9-14-11 cont PREVACID no difference with med cont episodes. Abd pain after prob 2-3 mo pain subsided then June 2012 knee pain/hip pain spondyloarthropathy. Dx autoimmune disorder dx during tx of juvenile arthritis. Abd pain/nausea returned again H2 blockers added, referred to GI, multiple diff meds for stomach, upper endoscopy performed - normal, US, gallbladder tests - neg, HIDA scan - abn w ejection fx, gallbladder surgery March 2013 continued abd pain/ nausea numerous tests referrals to GI, US endoscopy performed - normal, pain ctr. Still with abd pain episodes and nausea.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Endoscopy upper gastrointestinal tract normal, Gastric emptying study, Hepatobiliary scan, Hepatobiliary scan abnormal, Juvenile idiopathic arthritis
Clinical narrative: C/O abd pain/nausea approx 2 wks after injection. Seen physician approx 1 mo after injection 9-14-11 cont PREVACID no difference with med cont episodes. Abd pain after prob 2-3 mo pain subsided then June 2012 knee pain/hip pain spondyloarthropathy. Dx autoimmune disorder dx during tx of juvenile arthritis. Abd pain/nausea returned again H2 blockers added, referred to GI, multiple diff meds for stomach, upper endoscopy performed - normal, US, gallbladder tests - neg, HIDA scan - abn w ejection fx, gallbladder surgery March 2013 continued abd pain/ nausea numerous tests referrals to GI, US endoscopy performed - normal, pain ctr. Still with abd pain episodes and nausea.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Magnetic resonance cholangiopancreatography, Nausea, Spondyloarthropathy, Ultrasound biliary tract normal, Ultrasound liver
Clinical narrative: C/O abd pain/nausea approx 2 wks after injection. Seen physician approx 1 mo after injection 9-14-11 cont PREVACID no difference with med cont episodes. Abd pain after prob 2-3 mo pain subsided then June 2012 knee pain/hip pain spondyloarthropathy. Dx autoimmune disorder dx during tx of juvenile arthritis. Abd pain/nausea returned again H2 blockers added, referred to GI, multiple diff meds for stomach, upper endoscopy performed - normal, US, gallbladder tests - neg, HIDA scan - abn w ejection fx, gallbladder surgery March 2013 continued abd pain/ nausea numerous tests referrals to GI, US endoscopy performed - normal, pain ctr. Still with abd pain episodes and nausea.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from the registered nurse on 02-JAN-2014. It was reported that GARDASIL vaccines were stored in improper temperatures and were administered to overall number of 132 patients. This report refers to one of the patients involved: a patient of unspecified age and gender, who was administered dose of GARDASIL (dose and route unknown) on 04-JUN-2013, lot # and expiration date were not provided. No adverse event was reported. This is one of the report from the same source. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from the registered nurse on 02-JAN-2014. It was reported that GARDASIL vaccines were stored in improper temperature and were administered to overall number of 132 patients. This report refers to one of the patients involved: a patient of unspecified age and gender, who was administered dose of GARDASIL (dose and route unknown) on 10-JUN-2013, lot # H010915 expiration date 13-FEB-2015. No adverse event was reported. This is one of the report from the same source. Additional information is not expected.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Rash erythematous, Rash vesicular, Skin exfoliation
Clinical narrative: This spontaneous report as received from a 60 year old male pharmacist who is also the patient who has been prone to heat rash in the summer for the last three or four years and AUGMENTIN allergy. On 18-DEC-2013, the patient was (route not provided) vaccinated with ZOSTAVAX (lot number and expiry date not provided). Concomitant therapies included LIPITOR, vitamin D (unspecified) (manufacturer unknown), PRILOSEC and aspirin (manufacturer unknown). On 29-DEC-2013, 12 days after onset of therapy the patient experienced rash with blisters and peeling on his face and part of his neck. The pharmacist stated that the rash "looks like sunburn". The pharmacist was taking prednisone (manufacturer unknown) and FLOMAX (manufacturer unknown) to treat the rash which he has since stopped. The blisters went away; however, the redness, flaking and peeling is still occurring. The patient sought medical attention. The outcome of rash with blisters and peeling on his face and part of his neck was reported as recovering/resolving. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: FLUN4, FLUN4
Symptoms: Expired drug administered, No adverse event
Clinical narrative: Vaccine was administered after expiration date - no adverse events Exp. date was 12/2/13.
Age: 4.0
Sex: M
Vaccine: FLUN4, FLUN4
Symptoms: Expired drug administered
Clinical narrative: Vaccine was administered after expiration date - no adverse events Exp. date was 12/2/13.
Age: 4.0
Sex: F
Vaccine: FLUN4, FLUN4
Symptoms: Expired drug administered, No adverse event
Clinical narrative: Vaccine was administered after expiration date - no adverse events. Exp. date was 12/2/13.
Age: 4.0
Sex: F
Vaccine: FLUN4, FLUN4
Symptoms: Expired drug administered
Clinical narrative: Vaccine was administered after expiration date - no adverse events. Exp. date was 12/2/13.
Age: 3.0
Sex: F
Vaccine: FLUN4
Symptoms: Expired drug administered, No adverse event
Clinical narrative: Vaccine was administered after expiration date - no adverse events. Exp. date was 12/2/13.
Age: 11.0
Sex: M
Vaccine: FLUN4
Symptoms: Expired drug administered, No adverse event
Clinical narrative: Vaccine was administered after expiration date - no adverse events. Exp. date was 12/2/13.
Age: 3.0
Sex: F
Vaccine: FLUN4, FLUN4
Symptoms: Expired drug administered, No adverse event
Clinical narrative: Vaccine was administered after expiration date - no advserse events exp. date was 12/2/13.
Age: 3.0
Sex: F
Vaccine: FLUN4, FLUN4
Symptoms: Expired drug administered
Clinical narrative: Vaccine was administered after expiration date - no advserse events exp. date was 12/2/13.
Age: 14.0
Sex: M
Vaccine: FLUN4, FLUN4
Symptoms: Expired drug administered, No adverse event
Clinical narrative: Vaccine was administered after expiration date - no adverse events. Exp. date was 12/2/13.
Age: 14.0
Sex: M
Vaccine: FLUN4, FLUN4
Symptoms: Expired drug administered
Clinical narrative: Vaccine was administered after expiration date - no adverse events. Exp. date was 12/2/13.
Age: 4.0
Sex: M
Vaccine: FLUN4, FLUN4
Symptoms: Expired drug administered, No adverse event
Clinical narrative: Vaccine was administered after expiration date - no adverse events. Exp. date was 12/2/13.
Age: 4.0
Sex: M
Vaccine: FLUN4, FLUN4
Symptoms: Expired drug administered
Clinical narrative: Vaccine was administered after expiration date - no adverse events. Exp. date was 12/2/13.
Age: 71.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Blister, Injection site erythema, Injection site rash, Rash
Clinical narrative: Pt received ZOSTAVAX on 12-28-13 at pharmacy. On (R) arm. States within 3-4 days developed red erythematous rash at injection site. When seen by physician assistant on 1-14-14, pt had developed other areas of rash with blisters predominantly on (R) upper arm not crossing hemispheres. Pt denies have history of chicken pox. Pt was prescribed acyclovir 800 mg five times daily for 7 days.
Age: 3.0
Sex: M
Vaccine: FLUN4, FLUN4
Symptoms: Expired drug administered, No adverse event
Clinical narrative: Vaccine was administered after expiration date - no adverse events. Exp. date was 12/2/13.
Age: 3.0
Sex: M
Vaccine: FLUN4, FLUN4
Symptoms: Expired drug administered
Clinical narrative: Vaccine was administered after expiration date - no adverse events. Exp. date was 12/2/13.
Age: 16.0
Sex: M
Vaccine: FLU3
Symptoms: Nausea, Oedema peripheral
Clinical narrative: Over phone mother describes swelling in left armpit and pt experiencing nausea on morning of 1/15/2014 RPh - normal adverse reaction for age group - reported back info to mother and told her if symptoms did not improve in 24-48 contact Dr left message for follow up care 1/16/14.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Colitis microscopic, Colonoscopy abnormal, Diarrhoea
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 65 year old female patient with arthritis and drug reactions to clindamycin. The patient's medical history included breast cancer. On 06-DEC-2013, the patient was vaccinated with ZOSTAVAX lot # J011212, subcutaneous in the left arm. Concomitant therapies included CELEBREX, TAMOXIFEN CITRATE and history of 11 day course of DOXYCYCLINE in September 2013. On 07-DEC-2013, the patient developed diarrhea which continued intermittently for 1 month. The patient was evaluated by an unspecified physician who performed a colonoscopy on an unspecified date. The colonoscopy revealed microscopic lymphocytic colitis. The colitis resolved without requiring treatment. The outcome of microscopic lymphocytic colitis and diarrhea was reported as recovered/resolved. The action taken with ZOSTAVAX was not provided. The reporter did not assess the relationship between the events and ZOSTAVAX. Additional information has been requested.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site urticaria
Clinical narrative: Large reaction at site, redness, urticaria, pain and swelling.
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration, Injection site pain
Clinical narrative: This spontaneous report was received from a pharmacist refers to a female patients of unknown age. On an unknown date in the year 2013 (also reported as last year in spring or summer), the 2 patients were vaccinated with ZOSTAVAX (dose and frequency was not reported) intramuscular rather than subcutaneous. On an unknown date, the 2 patients experienced ZOSTAVAX injection hurt a lot and quite a bit. The outcome of the event ZOSTAVAX injection hurt a lot and quite a bit was reported as recovered. The reporter did not assessed the causality between the event and the suspect drug. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse. This report refers to a patient of unspecified age and gender, who had been administered a dose of VARIVAX (Merck) on 29-MAR-2013 (lot # 671341/1250AA, expiration date reported as 11-AUG-2013) that was stored in improper temperatures. No adverse event was reported. This is one of several reports from the same source. Additional information is not expected.
Sex: F
Vaccine: FLU3
Symptoms: Rash, Rash pruritic, Throat irritation
Clinical narrative: Administer annual flu shot on 1/6/14 patient states developed throat irritation that night. Next am notes small lumpy itchy rash to (R) shoulder blade, rt flank none on (L) side.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Blood pressure increased, Condition aggravated, Dizziness, Erythema, Feeling hot
Clinical narrative: Shortly after receiving vaccine, pt. got very flush, her face turned very red, she stated she wasn't feeling well and described her symptoms as hot, flush, dizzy, shaking and "tingly" feeling - called 911 immediately and EMS responded. Elevated blood pressure.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Flushing, Hypertension, Malaise, Paraesthesia, Tremor
Clinical narrative: Shortly after receiving vaccine, pt. got very flush, her face turned very red, she stated she wasn't feeling well and described her symptoms as hot, flush, dizzy, shaking and "tingly" feeling - called 911 immediately and EMS responded. Elevated blood pressure.
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Herpes zoster, Local swelling, Pruritus, Rash
Clinical narrative: 11-11-13 flu shot, then 15 mins later 11-11-13 shot to get rid of rash/itch 11-14-13 shingles onset. Got antiviral 11-27-13 hands and feet swollen and red like burned.
Age: 1.54
Sex: F
Vaccine: DTAP, HEPA, HIBV
Symptoms: Erythema, Induration
Clinical narrative: Rec'd 15 mo immunization at age 18 mo, on (T) 01/14/14. Seen again in office next eve. with 8 x 12 cm of firm, mildly warm erythema to (LT). Tx with ibuprofen and ice pack prn. To return if s/s increased or pt. develops fever.
Sex: M
Vaccine: FLUX
Symptoms: Ill-defined disorder, Malaise, Pyrexia
Clinical narrative: Initial report received from a non-health care professional (consumer) on 9 January 2014. A 63-year-old male patient, received first dose of Swine Flu vaccine (Lot number unknown, route and site of vaccination was not reported) on an unspecified date in 1976. It was reported that the patient was not certain about the symptoms except it is the sickest he has ever been. The patient also had high fever. The patient was hospitalized on an unspecified date. Vaccination and Pre-existing physician diagnosed allergies and birth defect was unknown. Laboratory details and corrective treatment was not reported. At the time of this report the patient was recovered from adverse event. Documents held by sender: none.
Sex: U
Vaccine: PNC13
Symptoms: Cellulitis, Rash
Clinical narrative: This is a spontaneous report from a contactable physician via a Pfizer Sales representative. This physician reported similar events for two patients. This is the second of two reports. This over 60 year old patient (race and gender unknown) received PREVNAR 13 on an unknown date. Relevant medical history and concomitant medication were unknown. It was reported that the patient experienced really bad rashes and cellulitis on an unknown date. Relevant laboratory data and therapeutic measures were unknown. Outcome was unknown at the time of report.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age. On 11-JUL-2013, the patient was vaccinated with a dose of VARIVAX (Merck) (lot number reported as H015557, expiration date 16-AUG-2014) (dose and route not reported) that was stored in improper temperatures. This is one of several reports from the same source. Additional information is not expected.
Sex: U
Vaccine: PNC13
Symptoms: Cellulitis, Rash
Clinical narrative: This is a spontaneous report from a contactable physician via a Pfizer Sales representative. This physician reported similar events for two patients. This is the first of two reports. This over 60 year old patient (race and gender unknown) received PREVNAR 13 on an unknown date. Relevant medical history and concomitant medication were unknown. It was reported that the patient experienced really bad rashes and cellulitis on an unknown date. Relevant laboratory data and therapeutic measures were unknown. Outcome was unknown at the time of report.
Sex: U
Vaccine: VARZOS
Symptoms: Headache
Clinical narrative: This spontaneous report was received from a pharmacist via company representative refers to a patient of unknown demography. On an unknown date, the patient was vaccinated with ZOSTAVAX (dose, route and frequency was not reported). On an unknown date, post vaccination, the patient experienced headache. The patient sought medical attention and went to pharmacy. The patient took the treatment with unspecified over the counter medication. The outcome of the event headache was unknown. The reporter did not provide the causality between the event and the suspect drug. Additional information is not expected.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Urticaria
Clinical narrative: Patient reported urticaria (hives) and pruritus several days after vaccination. No site irritation, inflammation, or swelling was observed when pt came in for consultation.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pyrexia, Rash macular
Clinical narrative: Started running a high fever in the middle of the night. Arm was red in area of injections, swelling and redness the size of an orange. Redness grew to span width of arm. Warm to touch. Redness and swelling has decreased as of 1400 on 1/13/14 and is "blotchy" instead of complete red. No more fever.
Age: 69.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Pyrexia
Clinical narrative: High fever in the middle of the night, low grade the next day. Redness at site of injection and soreness.
Age: 22.0
Sex: U
Vaccine: VARCEL
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 22 year old patient. Patient received dose 1 of VARIVAX (Merck) 0.5 ml, subcutaneous at the age of 1 years old in 1992. Lot number was not provided. In 2013 (reported as recently and at the age of 22 years old) the patient was vaccinated with VARIVAX (Merck) dose 2, 0.5 ml, subcutaneous. Lot number was not provided. The pharmacist reported that the reason the patient received the dose of VARIVAX (Merck) was for nursing school. No adverse effect reported. Additional information has been requested.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Disturbance in attention, Dizziness, Dyspnoea, Headache, Somnolence
Clinical narrative: Difficulty breathing, dizziness, somnolence, difficulty concentrating, severe headache.  Benadryl taken.
Age: 66.0
Sex: M
Vaccine: HEP
Symptoms: Hypoaesthesia, Muscle spasms, Myalgia, Pain in extremity
Clinical narrative: Leg pain and numbness. Patient reports pain in his legs as severe. He states that it was as if his leg were asleep with muscle aches and cramps. Lasting two days.
Age: 1.65
Sex: M
Vaccine: HEPA
Symptoms: Erythema, Rash erythematous, Urticaria
Clinical narrative: Red raised hives surround by red skin.  When hives are pressed they turn white.  Hives started on his bottom and then were next observed on his right leg and left arm.  They can then appear large with a red irregular ringed circle.  They range in size from 3 mm to 80 mm.  He had a previous hive reaction, but the vaccine was not known at the time.
Age: 38.0
Sex: F
Vaccine: HEP
Symptoms: Antinuclear antibody negative, Arthralgia, Full blood count normal, Influenza virus test negative, Red blood cell sedimentation rate normal
Clinical narrative: Diffuse joint pains.
Age: 38.0
Sex: F
Vaccine: HEP
Symptoms: Rheumatoid factor negative
Clinical narrative: Diffuse joint pains.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site streaking, Lymph node pain
Clinical narrative: Redness at site, soreness, red streaking down to armpit and sore lymph nodes.
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy, Wrong drug administered
Clinical narrative: Information has been received from a certified medical assistant for GARDASIL, a Pregnancy Registry product, concerning a female patient of unknown age. On an unknown date, the patient was inadvertently vaccinated with a dose of GARDASIL (dose, route and lot # not reported) rather than the flu vaccine. The patient became pregnant with LMP of 06-MAY-2013 and EDD of 10-FEB-2014. Initial exposure to GARDASIL was at 36 weeks. The pregnancy outcome was outcome pending. It was reported that the fetus was a low birth weight prior to the receipt of GARDASIL. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: MMR
Symptoms: Abdominal pain, Arthralgia, Henoch-Schonlein purpura, Malaise, Nausea
Clinical narrative: MMR on 8/26/13.  Rash on trunk the next day lasted a few days.  On day 10 he had malaise, day 14 he was noted to have joint pain of fingers, wrists bilaterally, ankles, elbow(s) knee and hip. He has had a migratory joint pain ever since.  Exam is unremarkable for sx of arthritis (effusion, erythema, redness, warmth).  Nausea QD x 3 weeks.   Also c/o SA unrelated to eating.   Temp was low grade right after the MMR. He returned to our office with a rash consistent with HSP, joint pains and abdomenal pain on 1/2/14.  Mom reports his rash improved after only a few days. Denies hallucinations, stiff neck, joint swelling.
Age: 5.0
Sex: M
Vaccine: MMR
Symptoms: Pyrexia
Clinical narrative: MMR on 8/26/13.  Rash on trunk the next day lasted a few days.  On day 10 he had malaise, day 14 he was noted to have joint pain of fingers, wrists bilaterally, ankles, elbow(s) knee and hip. He has had a migratory joint pain ever since.  Exam is unremarkable for sx of arthritis (effusion, erythema, redness, warmth).  Nausea QD x 3 weeks.   Also c/o SA unrelated to eating.   Temp was low grade right after the MMR. He returned to our office with a rash consistent with HSP, joint pains and abdomenal pain on 1/2/14.  Mom reports his rash improved after only a few days. Denies hallucinations, stiff neck, joint swelling.
Age: 28.0
Sex: M
Vaccine: HEP
Symptoms: Dizziness, Headache, Hot flush, Nausea
Clinical narrative: Hot flash, lightheaded, nausea, head ache.
Age: 11.0
Sex: M
Vaccine: HPV4
Symptoms: Arthralgia, Dizziness, Fatigue, Feeling abnormal, Full blood count
Clinical narrative: Within a day or so if getting the injection.  Patient began to experience numerous abnormal symptoms.  These included, dizziness, body aches, joint pain, headache, fatigue, brain fog, trouble sleeping, weakness especially in legs, ongoing sinus and upper respiratory problems.
Age: 11.0
Sex: M
Vaccine: HPV4
Symptoms: Headache, Insomnia, Metabolic function test, Mononucleosis heterophile test, Muscular weakness
Clinical narrative: Within a day or so if getting the injection.  Patient began to experience numerous abnormal symptoms.  These included, dizziness, body aches, joint pain, headache, fatigue, brain fog, trouble sleeping, weakness especially in legs, ongoing sinus and upper respiratory problems.