chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site inflammation, Injection site swelling, Paraesthesia, Pyrexia
Clinical narrative: This spontaneous report as received from a registered pharmacist refers to a 66 year old female patient. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (dose, route, and lot # not reported). The pharmacist reported that the patient experienced an injection site reaction with redness swelling and inflammation (no vesicles or blistering) about 4 inches in diameter accompanied by a tingling feeling from the elbow to the finger tips and fever that occurred recently (date unspecified). The exact onset of any symptoms was unspecified. Ibuprofen was given for the events. At the time of reporting, the outcome of the patient was unknown. It was unspecified whether the patient sought medical attention. Additional information has been requested.
Age: 0.8
Sex: M
Vaccine: MMR
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a consumer regarding his son an 8 months male patient. Medical history and drug allergies were not reported. ON an unknown date, the patient was vaccinated with  M-M-R II (concentration, dose and lot number were not reported) when he was 8 months of age. No adverse events were reported at this time. Additional information is not expected.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a Immunization Program refers to a patient of unknown age. On an unknown date the patient was vaccinated with a dose of improperly stored PNEUMOVAX23 (lot # H010515, expiration date 13-FEB-2014) (dose and route not reported). Additional information is not expected.
Age: 14.0
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 14 year old female patient. On 10-AUG-2013, the patient was vaccinated with the first dose of GARDASIL injection, 0.5 ml, intramuscular. The second dose of GARDASIL on 20-OCT-2011 and the third dose of GARDASIL on 25-OCT-2013. No adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information was received from a dentist regarding several patients. On an unknown date, patients were vaccinated with ZOSTAVAX. It was reported that several patients had developed shingles after vaccination with ZOSTAVAX. No further information was provided. Additional information is not expected.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a 14 year old female patient. In 2011, the patient was vaccinated with the first 0.5 ml dose of GARDASIL (Lot # not reported) intramuscularly and on 08-NOV-2013, the patient received the second 0.5 ml dose of GARDASIL (Lot # not reported) intramuscularly. No adverse effects were reported. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Incomplete course of vaccination
Clinical narrative: Information was received from a registered nurse regarding a patient (gender not provided), who several years ago, at the age of 18, received the first dose of GARDASIL (dosage and route of administration not provided). The patient, now 26 years old, came to the office inquiring about completion of the GARDASIL doses. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative refers to a 66 year old female patient. Medical history and drug allergies were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX (concentration, dose, frequency and lot number were not reported). No concomitant therapy was reported. On an unknown date, the patient experienced unusually large injection site rashes 10 days after receiving ZOSTAVAX. The rash was extremely swollen, hot and red. The patient did not sought medical attention. The outcome of the event was unknown. This is one of several reports from the same source. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Secondary transmission
Clinical narrative: Information was received by a pharmacist. Between 2011 to 2012, a patient was vaccinated with ZOSTAVAX. It was reported that the patient's mother-in-law was diagnosed with shingles one to two weeks later. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Cough, Injection site cellulitis, Injection site erythema, Injection site induration
Clinical narrative: Cellulitis to (L) upper arm at injection site 26 cm from shoulder to mid arm and 17 cm around with induration and warmth. Sensitive to touch, redness, cough, runny nose, chills.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site warmth, Rhinorrhoea
Clinical narrative: Cellulitis to (L) upper arm at injection site 26 cm from shoulder to mid arm and 17 cm around with induration and warmth. Sensitive to touch, redness, cough, runny nose, chills.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Haematochezia
Clinical narrative: Bloody stools with bright red blood, spots and strands about a quarter size each.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy, No adverse event, Pregnancy test
Clinical narrative: This spontaneous prospective pregnancy report as received from a nurse refers to a 23 years old female with naproxen, penicillin G and sulfa drug allergy. The patient's history of previous pregnancies and live births was not known. On 04-APR-2012, the patient was vaccinated with the first dose of GARDASIL (dose, route, lot and indication were not reported), on 08-MAY-2012, patient received the second dose of GARDASIL (dose, route, lot and indication were not reported), and on 11-SEP-2012 the third dose of GARDASIL (dose, route, lot and indication were not reported). Concomitant medications included iron (unspecified), ranitidine, glycopyrrolate, solium fluoride, sertraline hydrochloride and sucralfate. The patient, who received complete GARDASIL series was pregnant. The estimated Last Menstrual Period  was 10-AUG-2012, and the reported due date: 17-MAY-2013. Pregnancy test was performed (results were not reported). The patient sought medical attention (seen in clinic). No treatment was given for pregnancy. No adverse event was reported. Additional information has been requested.
Age: 80.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister
Clinical narrative: This spontaneous report as received from a registered pharmacist refers to a 80 year old female patient with diabetes, hypertension, high triglycerides and latex allergy. ON 08-OCT-2013, the patient was vaccinated with ZOSTAVAX (19400 PFU), 0.65 ml, subcutaneous, lot # J004600, expiration date: 18-JUL-2014. No concomitant medications were reported. On 23-OCT-2013, the patient had a vesicular bump near her injection site, it was only one "bump", but it seemed to have a vesicle. Th epatient applied an unspecified "anti-itch cream" to the vesicle on 23-OCT-2013 (also reported as "no treatment was given for the adverse event") and the vesicle was completely resolved "within a day". The patient consulted pharmacist. On 24-OCT-2013, the patient was completely recovered (also reported as "not recovered"). Additional information has been requested.
Age: 80.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site vesicles
Clinical narrative: This spontaneous report as received from a registered pharmacist refers to a 80 year old female patient with diabetes, hypertension, high triglycerides and latex allergy. ON 08-OCT-2013, the patient was vaccinated with ZOSTAVAX (19400 PFU), 0.65 ml, subcutaneous, lot # J004600, expiration date: 18-JUL-2014. No concomitant medications were reported. On 23-OCT-2013, the patient had a vesicular bump near her injection site, it was only one "bump", but it seemed to have a vesicle. Th epatient applied an unspecified "anti-itch cream" to the vesicle on 23-OCT-2013 (also reported as "no treatment was given for the adverse event") and the vesicle was completely resolved "within a day". The patient consulted pharmacist. On 24-OCT-2013, the patient was completely recovered (also reported as "not recovered"). Additional information has been requested.
Age: 74.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Dysgeusia
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 74 year old female patient with hypertension and drug reactions/allergies to latex. On 01-NOV-2013, at 10:00 am, the patient was vaccinated with ZOSTAVAX  vial (19400 PFU) (lot number J006157, expiry date 30-AUG-2014) (dose 0.65 ml), via subcutaneous route. Concomitant therapies included ASPIRIN. on 01-NOV-2013, in the evening, 7 to 8 hours after receiving the vaccine, the patient experienced nausea as well as metallic taste in her mouth. The pharmacist reported that at the time of report, the patient was no longer experiencing nausea but still had the metallic taste in her mouth. The patient called her unspecified primary care provider, on 07-NOV-2013, to discuss the reaction. The outcome of metallic taste in her mouth was reported as not resolved. The outcome of nausea was reported as resolved. No treatment was given for the events. Additional information has been requested.
Age: 74.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Dysgeusia, Nausea
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 74 year old female patient with hypertension and drug reactions/allergies to latex. On 01-NOV-2013, at 10:00 am, the patient was vaccinated with ZOSTAVAX  vial (19400 PFU) (lot number J006157, expiry date 30-AUG-2014) (dose 0.65 ml), via subcutaneous route. Concomitant therapies included ASPIRIN. on 01-NOV-2013, in the evening, 7 to 8 hours after receiving the vaccine, the patient experienced nausea as well as metallic taste in her mouth. The pharmacist reported that at the time of report, the patient was no longer experiencing nausea but still had the metallic taste in her mouth. The patient called her unspecified primary care provider, on 07-NOV-2013, to discuss the reaction. The outcome of metallic taste in her mouth was reported as not resolved. The outcome of nausea was reported as resolved. No treatment was given for the events. Additional information has been requested.
Age: 44.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Condition aggravated, Epilepsy, Petit mal epilepsy
Clinical narrative: Case number PHEH2013US023145, is an initial spontaneous report received from the consumer (patient) on 04 Nov 2013. This report refers to a 44-year-old female patient. Her medical history included epilepsy which have been well controlled with LAMICTAL and phenobarbital. She was vaccinated with FLUVIRIN (batch number: 13395P) intramuscularly on 01 Nov 2013. Immediately after receiving the vaccine, she experienced a partial seizure. The patient recovered completely at the time of reporting. The seriousness and causality were not reported. No additional information was available.
Age: 44.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Convulsion
Clinical narrative: Case number PHEH2013US023145, is an initial spontaneous report received from the consumer (patient) on 04 Nov 2013. This report refers to a 44-year-old female patient. Her medical history included epilepsy which have been well controlled with LAMICTAL and phenobarbital. She was vaccinated with FLUVIRIN (batch number: 13395P) intramuscularly on 01 Nov 2013. Immediately after receiving the vaccine, she experienced a partial seizure. The patient recovered completely at the time of reporting. The seriousness and causality were not reported. No additional information was available.
Age: 44.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Immediate post-injection reaction, Partial seizures
Clinical narrative: Case number PHEH2013US023145, is an initial spontaneous report received from the consumer (patient) on 04 Nov 2013. This report refers to a 44-year-old female patient. Her medical history included epilepsy which have been well controlled with LAMICTAL and phenobarbital. She was vaccinated with FLUVIRIN (batch number: 13395P) intramuscularly on 01 Nov 2013. Immediately after receiving the vaccine, she experienced a partial seizure. The patient recovered completely at the time of reporting. The seriousness and causality were not reported. No additional information was available.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Headache, Oropharyngeal pain, Pain
Clinical narrative: Pain in joints, wheezing in chest. Extreme headache, sore throat, swollen glands.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Headache, Lymphadenopathy, Oropharyngeal pain, Wheezing
Clinical narrative: Pain in joints, wheezing in chest. Extreme headache, sore throat, swollen glands.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Feeling cold, Local swelling, Pruritus
Clinical narrative: Pt. called pharmacy at 8:00 pm after receiving vaccines around noon same day complained of itching, swelling in arm and feeling cold.
Age: 20.0
Sex: M
Vaccine: MNQ
Symptoms: Headache, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Severe headache. Stiffness. Pain in legs. Started today (11/13/13) and continues.
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy, Human chorionic gonadotropin positive
Clinical narrative: This spontaneous prospective pregnancy report as received from a nurse on behalf of physician refers to a female patient of unknown age. The patient's medical history included irregular periods and one or two miscarriages. Patient had no drug reactions/allergies. Approximately on an unknown date in April 2013 (reported as 6 months ago), the patient was vaccinated with a first dose of GARDASIL (lot number, expiry date were not reported) 0.5 milliliter (ml) intramuscularly. On 20-JUN-2013, the patient was vaccinated with a second dose of GARDASIL (lot number, expiry date were not reported) 0.5 ml intramuscularly. The results of urine pregnancy tests on 18-OCT-2013 and 21-OCT-2013 were negative. On 21-OCT-2013, the patient was vaccinated with a third dose of GARDASIL, 0.5 ml intramuscularly. The result of "HCG" (human chorionic gonadotropin) blood test for pregnancy on 25-OCT-2013 was 19,000. Patient sought medical attention for the same. Patient stated to nurse that she was 4 to 6 weeks pregnant. Accordingly the patient became pregnant with Last menstrual period (LMP) of approximately September 2013. The pregnancy outcome was pending. Additional information has been requested.
Sex: U
Vaccine: PPV
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. On 16-OCT-2013 the patient ws vaccinated with PNEUMOVAX23 intramuscularly (lot # J000388 exp. date: 06-AUG-2014), (dose, strength, site of administration not reported). The reporter stated that PNEUMOVAX23 was exposed to -2.8C for 66 hours with the vaccine possibly going above and below 0C more than two times during this excursion. No adverse effect reported. This is one of two reports from the same reporter (MARRS case # 1310USA010366). Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Adverse reaction
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. On an unknown date the patient was vaccinated with M-M-R II (dose and route unknown). No concomitant medications were reported. On an unknown date the patient experienced unspecified reaction to a dose of M-M-R II. The outcome of unspecified reaction is unknown. Additional information has been requested.
Age: 37.0
Sex: M
Vaccine: HEP
Symptoms: Antibody test negative, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker nurse refers to a 37 year old male patient. On 06-SEP-2013, the patient was vaccinated with the first dose of RECOMBIVAX HB (lot # H010965, Exp date 01-JUN-2014), injection "10 Y", 1.0 ml, intramuscular. On 31-OCT-2013, the patient was vaccinated with the second dose of RECOMBIVAX HB (lot # reported as J003580, Exp date 07-NOV-2014), injection "10 Y", 1.0 ml, intramuscular. On 07-NOV-2013, serologic testing did not show any antibody. No treatment was given for the events. No adverse effect reported. It was unspecified if the patient sought medical attention. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site paraesthesia, Rash
Clinical narrative: This spontaneous report as received from a pharmacist refers to an approximately 65 year old female patient. The patient's pertinent medical history was none. The patient had drug reactions/allergies to penicillin with unspecified reactions. On 29-OCT-2013 the patient was vaccinated with ZOSTAVAX (vial 19400 PFU) lot # J006828, expiry date 14-SEP-2013, dose 0.65 ml, subcutaneous. No concomitant medications were reported. Approximately 30-OCT-2013 (reported as 1-2 days after) the patient experienced red area at the injection site. It was reproted that there was no vesicles at reddened injection site and the patient reported that it felt prickly (approximately 30-OCT-2013). The patient reported of experiencing cold symptoms of coughing, sneezing and chills before the injection. The patient sought medical attention and visited her physician and was prescribed with unspecified steroid cream and the rash resolved on 03-NOV-2013. The outcome of felt prickly is unknown. No lab diagnostics studies were performed. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered pharmacist refers to a patient of unknown demographics. On 04-NOV-2013, the patient was vaccinated with RECOMBIVAX HB 10 dose 2 (lot number, expiration date and route of administration not reported). No concomitant medications were reported. On 04-NOV-2013, it was reported that the second dose of RECOMBIVAX HB 10 was administered only two weeks after the first dose. No adverse effects were reported. 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 licensed practical nurse refers to a patient of unknown age. On 26-JUN-2008 the patient was vaccinated with the first dose of GARDASIL (lot number, expiry date, route unknown). On 04-SEP-2013, the patient was then administered 2nd dose of GARDASIL (lot number, expiry date, route unknown). No concomitant medications were reported. No adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse concerning an unknown number of patients of unknown age and gender. It was reported that on unknown date in 2013 (also reported as from 19-JUL-2013 until 17-OCT-2013), the patients were vaccinated with improperly stored doses of GARDASIL (lot number, expiry date, dose and route unspecified). No concomitant therapy was reported. No adverse effect was reported. This is one of the two reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from an unknown reporter from an immunization program refers to a patient of unknown age or gender. On an unknown date the patient was vaccinated with GARDASIL (dose and route not reported, lot # J003727, expired date 07-NOV-2015). It was reported that GARDASIL was improperly stored vaccine. Additional information is not expected.
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Femoral hernia repair, Haematoma evacuation, Herpes zoster, Inguinal hernia repair
Clinical narrative: This spontaneous report as received from a male physician of 82 years old refers to himself. The patient's current condition included bronchial asthma, hay fever, hypertension and quintuple coronary artery bypass. Concerning drug allergies he developed skin lesions after receiving an unspecified sulfa medication on an unspecified date. In May 2007, the patient was vaccinated with a dose of ZOSTAVAX (lot#, expiration date, dose and route not reported). In 1996, the patient began 0.125mg DIGOXIN. Then, "eight years ago" (in approximately November 1995) he was diagnosed with mild pancytopenia. He reported that his white blood count was less than 2,000; hemoglobin 9.2; platelets 100,000. Concomitant therapies included simvastatin (manufacturer unknown). The patient reported that in approximately November 2009 (four years ago), he had a "TUR" (prostate surgery) and was diagnosed with mild carcinoma of the prostate. He reported that in about November 2010 (three years ago) he developed muscle and joint pain and saw his primary care physician. He stated that he had a "sed rate" drawn and the results were "80" and he was then diagnosed with polymyalgia rheumatica- treatment had been daily prednisone (manufacturer unknown) since then. The patient reported that in about November 2010 (three years ago) he was diagnosed with an inguinal hernia, 6 months later it was bulging. In March 2013, he had surgery for femoral hernia and an inguinal hernia repair in August 2013 in which he developed a large hematoma at the site which required evacuation. He stated that in September 2013 (two months ago), he developed shingles affecting the 5th cranial nerve of the left eye. He stated that he developed minimal involvement of the left retina, but did have crusty lesions on the left side of his head around the left eye without pain. He reported that he was treated with an unspecified antiviral for 15 days. The physician also noted that he has taken 20mg-40mg of an simvastatin (manufacturer unspecified) and bases his daily dose upon the leg cramps he develops from the medication. The shingles was resolved on an unspecified date and the polymyalgia rheumatic was not recovered. The outcome of other adverse events was unknown. Additional information has been requested.
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site haematoma, Muscle spasms, Myalgia, Polymyalgia rheumatica, Prostate cancer
Clinical narrative: This spontaneous report as received from a male physician of 82 years old refers to himself. The patient's current condition included bronchial asthma, hay fever, hypertension and quintuple coronary artery bypass. Concerning drug allergies he developed skin lesions after receiving an unspecified sulfa medication on an unspecified date. In May 2007, the patient was vaccinated with a dose of ZOSTAVAX (lot#, expiration date, dose and route not reported). In 1996, the patient began 0.125mg DIGOXIN. Then, "eight years ago" (in approximately November 1995) he was diagnosed with mild pancytopenia. He reported that his white blood count was less than 2,000; hemoglobin 9.2; platelets 100,000. Concomitant therapies included simvastatin (manufacturer unknown). The patient reported that in approximately November 2009 (four years ago), he had a "TUR" (prostate surgery) and was diagnosed with mild carcinoma of the prostate. He reported that in about November 2010 (three years ago) he developed muscle and joint pain and saw his primary care physician. He stated that he had a "sed rate" drawn and the results were "80" and he was then diagnosed with polymyalgia rheumatica- treatment had been daily prednisone (manufacturer unknown) since then. The patient reported that in about November 2010 (three years ago) he was diagnosed with an inguinal hernia, 6 months later it was bulging. In March 2013, he had surgery for femoral hernia and an inguinal hernia repair in August 2013 in which he developed a large hematoma at the site which required evacuation. He stated that in September 2013 (two months ago), he developed shingles affecting the 5th cranial nerve of the left eye. He stated that he developed minimal involvement of the left retina, but did have crusty lesions on the left side of his head around the left eye without pain. He reported that he was treated with an unspecified antiviral for 15 days. The physician also noted that he has taken 20mg-40mg of an simvastatin (manufacturer unspecified) and bases his daily dose upon the leg cramps he develops from the medication. The shingles was resolved on an unspecified date and the polymyalgia rheumatic was not recovered. The outcome of other adverse events was unknown. Additional information has been requested.
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Red blood cell sedimentation rate increased, Scab, Transurethral prostatectomy
Clinical narrative: This spontaneous report as received from a male physician of 82 years old refers to himself. The patient's current condition included bronchial asthma, hay fever, hypertension and quintuple coronary artery bypass. Concerning drug allergies he developed skin lesions after receiving an unspecified sulfa medication on an unspecified date. In May 2007, the patient was vaccinated with a dose of ZOSTAVAX (lot#, expiration date, dose and route not reported). In 1996, the patient began 0.125mg DIGOXIN. Then, "eight years ago" (in approximately November 1995) he was diagnosed with mild pancytopenia. He reported that his white blood count was less than 2,000; hemoglobin 9.2; platelets 100,000. Concomitant therapies included simvastatin (manufacturer unknown). The patient reported that in approximately November 2009 (four years ago), he had a "TUR" (prostate surgery) and was diagnosed with mild carcinoma of the prostate. He reported that in about November 2010 (three years ago) he developed muscle and joint pain and saw his primary care physician. He stated that he had a "sed rate" drawn and the results were "80" and he was then diagnosed with polymyalgia rheumatica- treatment had been daily prednisone (manufacturer unknown) since then. The patient reported that in about November 2010 (three years ago) he was diagnosed with an inguinal hernia, 6 months later it was bulging. In March 2013, he had surgery for femoral hernia and an inguinal hernia repair in August 2013 in which he developed a large hematoma at the site which required evacuation. He stated that in September 2013 (two months ago), he developed shingles affecting the 5th cranial nerve of the left eye. He stated that he developed minimal involvement of the left retina, but did have crusty lesions on the left side of his head around the left eye without pain. He reported that he was treated with an unspecified antiviral for 15 days. The physician also noted that he has taken 20mg-40mg of an simvastatin (manufacturer unspecified) and bases his daily dose upon the leg cramps he develops from the medication. The shingles was resolved on an unspecified date and the polymyalgia rheumatic was not recovered. The outcome of other adverse events was unknown. Additional information has been requested.
Age: 28.0
Sex: U
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an approximately 28 year old patient. On 12-SEP-2013 the patient (who was approximately 28 year old then)was vaccinated with the first dose of GARDASIL (lot number, expiry date, route and dose unknown). No adverse event reported. No other information to the report. Additional information is not expected.
Sex: F
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: This spontaneous report as received from a Medical Assistant via company representative concerning a female patient of unknown age. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (dose, route, lot # and expiration date not provided). No other co-suspect therapy was reported. Concomitant medications were not provided. It was reported that on an unknown date, the patient experienced zoster-like rash after vaccination with ZOSTAVAX. The outcome of patient was unknown. This is one of two reports concerning the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from an Immunization Program refers to a patient of unknown age. On an unknown date the patient was vaccinated with a dose of improperly stored PNEUMOVAX23 (lot # J006921, expiration date: 09-AUG-2014) (dose and route not reported). Additional information is not expected.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from an Immunization Program refers to a patient of unknown age. On an unknown date the patient was vaccinated with a dose of improperly stored PNEUMOVAX23 (lot # H010515, expiration date 13-FEB-2014) (dose and route not reported). Additional information is not expected.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: This spontaneous report as received from a pharmacist  refers to a 70 year old female patient with hypercholesterolemia and no known drug allergies. On 24-OCT-2013 the patient was vaccinated with a 0.65 ml dose of ZOSTAVAX (lot # J006155, exp date 30-AUG-2013) subcutaneously in the left arm. Concomitant therapies included simvastatin (manufacturer unknown). The patient who received ZOSTAVAX reported that she began to experience body aches "a few days later". The pharmacist speculated that the patient began to experience this sensation approximately Tuesday, 29-OCT-2013, but she was not certain. She provided the administration details, and then she placed the patient on the phone to provide the following information: "I developed an achy feeling in my neck, shoulders, arms and legs." The consumer stated that she has not notified her physician. No treatment was given. The outcome of the event was reported as not recovered/not resolved. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: VARZOS
Symptoms: Accidental exposure to product, Conjunctival hyperaemia, Eye pruritus
Clinical narrative: This spontaneous report was received from a physician concerning a 23 year old medical assistant female patient in her office. The patient's medical history included varicella. The patient's pertinent drug reactions/allergies were unknown. Seven dates ago, on 11-OCT-2013 the patient was preparing a dose of ZOSTAVAX (lot number and expiration date were not provided) when it splashed in her eye. Co-suspect therapies and concomitant medications were not provided. On 18-OCT-2013, 8 days after ZOSTAVAX was splashed in her eye (also reported as 19-OCT-2013), the patient began to experience mild itching and redness in the conjunctiva/mild erythema of the part of conjunctiva (no scleral, corneal or visual changes). It was reported that she did not irrigate the eye. At the time of the report, the patient had not recovered from the event. The relatedness between the events and suspect therapy was unknown. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a licensed nurse practitioner concerning a patient of unknown demographics. The patient's medical history and concurrent conditions information was not provided. On 11-NOV-2013, the patient was administered with expired dose of ROTATEQ. The reported lot# was 0382AE and expiry date was 20-OCT-2013. No adverse effect was reported. No product quality complaint (PQC) was involved. Same reporter link: 1311USA002302. Additional information is not expected.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. The RECOMBIVAX doses were exposed to 50 Fahrenheit since 07-NOV-2013. On 09-NOV-2013 the patient was vaccinated with RECOMBIVAX HB (dose, lot and expiry date were unknown). The patient has received improperly stored RECOMBIVAX. No adverse effect was reported. This is 1 of 3 reports from same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker (licensed vocational nurse) refers to a patient of unknown age and gender. Medical history and drug reactions/allergies were not reported. On 21-OCT-2013, the patient was vaccinated with VARVIAX (Merck) (lot, dose and route not reported) and PROQUAD (lot, dose and route not reported). Concomitant medication was not reported. No adverse symptoms reported. 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 a pharmacist refers to a patient of unknown age. The RECOMBIVAX doses were exposed to 50 Fahrenheit since 07-NOV-2013. On 09-NOV-2013 the patient was vaccinated with RECOMBIVAX HB (dose, lot and expiry date were unknown). The patient had received improperly stored RECOMBIVAX. No adverse effect was reported. This is 2 of 3 reports from same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from an unknown reporter refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (lot # J000445, expiration date 11-APR-2014), (dose and route unspecified). The outcome of the event was unknown. This is one of several reports received from same source. Additional information is not expected.
Sex: M
Vaccine: FLU3
Symptoms: Blindness, Chills, Gaze palsy, Hyperhidrosis, Loss of consciousness
Clinical narrative: Case number PHEH2013US023169, is an initial spontaneous report received from a consumer on 05 Nov 2013. This report refers to a male patient of unspecified age. His medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: 1308601, expiry date: Mar 2014) on 29 Sep 2013. Five minutes after vaccination, he experienced chills, loss of vision, profuse sweating, and loss of consciousness. His eyes rolled, vitals dropped (values not reported) and he turned grey. On the same day, the events subsided. The seriousness and causality were not reported. No additional information was available.
Sex: M
Vaccine: FLU3
Symptoms: Pallor, Vital functions abnormal
Clinical narrative: Case number PHEH2013US023169, is an initial spontaneous report received from a consumer on 05 Nov 2013. This report refers to a male patient of unspecified age. His medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: 1308601, expiry date: Mar 2014) on 29 Sep 2013. Five minutes after vaccination, he experienced chills, loss of vision, profuse sweating, and loss of consciousness. His eyes rolled, vitals dropped (values not reported) and he turned grey. On the same day, the events subsided. The seriousness and causality were not reported. No additional information was available.
Age: 1.3
Sex: F
Vaccine: MMRV, VARCEL
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report as received from the treating nurse and physician with the medical practice via company representative to report a vaccine administered outside of PI. The reporter refers to a 15 months old female child. On separate unspecified dates, the child was vaccinated with a dose of PROQUAD, (lot #, dose, route, strength, and indication not reported) and VARIVAX (Merck) (lot #, dose and strength not reported), injection. The reporter stated that child was now 15 months old. The first vaccine, thought to be PROQUAD, was administered at 12 months and the second, thought to be VARIVAX (Merck), as administered at 15 months. No adverse effect reported. It was unspecified if the patient sought medical attention. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site nodule
Clinical narrative: This spontaneous report as received from registered nurse refers to a 60 year old male patient with drug reaction/allergy to honey who was also a friend of the reporter. Pertinent medical history and concomitant medication were reported as none. On 09-NOV-2013, the patient was vaccinated with ZOSTAVAX vial (19400 PFU), in his deltoid muscle of the left arm by the intramuscular route. On 12-NOV-2013, the patient experienced knot and reddened area at the left arm, administration site. No treatment was given for events. Lab diagnostics studies performed were none. The outcome of events was reported as not resolved. Patient did not seek medical attention. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site discomfort, Injection site erythema, Injection site hypersensitivity, Injection site induration, Injection site reaction
Clinical narrative: This spontaneous report was received from a 65 year old male patient concerning himself. On 30-OCT-2013 the patient was vaccinated with ZOSTAVAX, therapy route: injection (dose, lot number and expiry unspecified). Beginning the follow day, on 31-OCT-2013, the patient began to experience an injection-site reaction which included hardness, redness, sensitivity and injection site discomfort. The patient reports that as of Monday, 04-NOV-2013, the outcome of injection site discomfort, injection site sensitivity, injection site hardness and injection site redness was reported as not resolved. Causality assessment was not provided. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse concerning an unknown number of patients of unknown age and gender. IT was reported that on unknown date in 2013 (also reported as from 19-JUL-2013 until 17-OCT-2013), the patients were vaccinated with improperly stored doses of liquid PEDVAXHIB (lot number, expiry date, dose and route unspecified). No concomitant therapy was reported. No adverse effect was reported. This is one of the two reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from an unknown reporter from an immunization program refers to a patient of unknown age or gender. On an unknown date the patient was vaccinated with GARDASIL (dose and route not reported, lot # J003727, expired date 07-NOV-2014). It was reported that GARDASIL was improperly stored vaccine. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Blood pressure decreased, Dizziness, Loss of consciousness
Clinical narrative: This spontaneous report as received from a registered nurse refers to "a lot of patients" with unknown ages. On an unknown date, the patients were vaccinated with GARDASIL, intramuscular (dose and lot number were not reported). No concomitant medications were reported. On an unknown date, the reporting nurse, who oversees three offices, had seen a lot of patients passing out after receiving GARDASIL. She reported that at least one in every five patients passed out, with a drop in blood pressure, this usually occurs immediately or within a five minute period after vaccination. Additionally, at least three in five patients experienced feeling dizzy and light-headed after vaccination. Treatment protocol was all patients are required to remain in a safe position for 15 minutes after vaccination and if a patient passed out, nurse positioned patient on bed with feet up and monitors blood pressure, wand within a few minutes, patient was fine. The outcome of drop in blood pressure, feeling dizzy and light-headed after vaccination and passing out after receiving GARDASIL was unknown. This is one of several reports received from the same source (MARRS # 1310USA012759). Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. On 09-NOV-2013 the patient was vaccinated with M-M-R II injection (dose, lot and expiry date unknown). The M-M-R II doses were exposed to 52 Fahrenheit since 07-NOV-2013. No adverse effect was reported. This is 1 of 2 reports from same reporter. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Fibromyalgia
Clinical narrative: This spontaneous report was received from a nurse practitioner concerning her mother of unknown age with. Concurrent medical condition included fibromyalgia. On an unknown date, the patient was vaccinated with ZOSTAVAX (lot number, expiry date, dose and route unspecified). No concomitant medication was reported. On an unknown date, the patient stated that ZOSTAVAX shot caused a flare up of her fibromyalgia. The exact symptoms were not specified. The outcome of the event was unknown. The relatedness of the event of ZOSTAVAX was unknown. Additional information has been requested.
Age: 59.0
Sex: M
Vaccine: FLU3
Symptoms: Rheumatoid arthritis
Clinical narrative: Case number PHEH2013US022985 is an initial spontaneous report from consumer (patient) received on 31 Oct 2013. This case refers to 59-year-old male patient. His vaccination history included vaccination with FLUVIRIN after which he developed rheumatoid arthritis (see case: PHEH2013US022979). He was vaccinated with FLUVIRIN (batch number: not reported) intramuscularly, around 01 Oct 2013. On an unknown date after vaccination, he developed rheumatoid arthritis. The patient was on methylprednisone and methotrexate to keep the inflammation down. The reporter stated that his symptoms were related FLUVIRIN vaccination. The seriousness and outcome of event was not reported.
Age: 6.0
Sex: F
Vaccine: DTAP, VARCEL
Symptoms: Injection site discolouration, Injection site erythema, Injection site swelling
Clinical narrative: Administered 11/12/13 patient was 6 then is 7 now. INFANRIX given RD IM. VARIVAX RA SQ. Normal redness VARIVAX 4 inches down from where DTAP administer red/purple and swollen.
Age: 45.0
Sex: U
Vaccine: FLU3, TDAP
Symptoms: Induration, Local swelling, Pain in extremity, Urticaria
Clinical narrative: Evening of receiving TDAP, PT's (R) arm swelled, became hard, painful -hives on arm, up neck to face for 24 hrs. No problems breathing or other symptoms.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. The RECOMBIVAX doses were exposed to 50 Fahrenheit since 07-NOV-2013. On 10-NOV-2013 the patient was vaccinated with RECOMBIVAX HB (dose, lot and expiry date were unknown). The patient had received improperly stored RECOMBIVAX. No adverse effect was reported. This is 3 of 3 reports from same reporter. Additional information has been requested.
Age: 59.0
Sex: M
Vaccine: FLU3
Symptoms: Rheumatoid arthritis
Clinical narrative: Case number PHEH2013US022979 is an initial spontaneous report from consumer (patient) received on 31 Oct 2013. This case refers to 59-year-old male patient. He was vaccinated with FLUVIRIN (batch number: not reported) intramuscularly on an unspecified date in Aug 2012. On an unknown date, within two weeks after the vaccination, he developed rheumatoid arthritis. He had been seeing a rheumatoid specialist since Apr 2013. The patient had got FLUVIRIN vaccination around 01 Oct 2013 and developed rheumatoid arthritis again (see case: PHEH2013US022985). The seriousness, outcome and causality of event were not reported.
Age: 50.0
Sex: M
Vaccine: FLU3
Symptoms: Influenza
Clinical narrative: Case number PHEH2013US023020 is an initial spontaneous report received from a nurse on 31 Oct 2013. This report refers to a 50-year-old male patient. He was vaccinated with FLUVIRIN (batch number:  unknown) intramuscularly on an unspecified date. On 31 Oct 2013, one month after receiving FLUVIRIN, he experienced flu. Outcome, seriousness and causality of the event were not reported.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Joint range of motion decreased, Musculoskeletal pain, X-ray
Clinical narrative: C/O pain in (L) shoulder - persistent w/some loss of motion. Subacromial injection f/u - physical therapy and anti inflammatory meds.
Sex: U
Vaccine: FLUX
Symptoms: Blood cytokine test, Condition aggravated, Laboratory test abnormal, Systemic lupus erythematosus
Clinical narrative: This case was reported in a literature article and described the occurrence of systemic lupus erythematosis flare in a subject of unspecified age and gender who was vaccinated with Influenza vaccine (manufacturer unspecified). Subject's medical condition included Systemic Lupus Erythematosus. On an unspecified date, the subject received an unspecified dose of Influenza vaccine unspecified (unknown route and injection site, batch number not provided). 6 weeks after vaccination with Influenza vaccine unspecified, the subject experienced systemic lupus erythematosis flare (SELENA-SLEDAI defined disease flare0. Plasma samples were obtained from the subject on the day of )influenza vaccination and at 6 weeks post vaccination. Plasma samples were tested for 52 soluble inflammatory mediators using XMAP technology. TNFR family members, TNFRI, TNFRII, Fas, FasL, CD40L, were increased. This case was assessed as medically serious by GSK. At the time of reporting, the outcome of the event was unspecified. Summary of the article: This literature article referred to 28 Systemic Lupus Erythematosus (SLE) patients (age and gender not specified) who exhibited SELENA-SLEDAI defined disease flare after 6 (n=13) or 12 (n=15) weeks post influenza vaccination (manufacturer, dosage and injection sites unknown) on an unspecified date. Subjects' medical history and concomitant medications at the time of the event were unknown. Twenty-eight SLE patients exhibited SELENA-SLEDAI defined disease flare after 6 (n=13) or 12 (n=15) weeks post influenza vaccination (manufacturer, dosage and injection sites unknown) on an unspecified date. These 28 patients were part of a study conducted to understand mechanisms and identify biomarkers of flare to help prevent damage and improve management. Plasma samples were obtained from SLE patients on the day of influenza vaccination (BL) and at 6 and 12 weeks post (FU). Each SLE patient was matched to a unique SLE patient who did not flare (NF), and to a healthy control (HC). Samples from 13 SLE patients with flare were compared to samples from a non-flare year (self nonflare, SNF). Plasma samples were tested for 52 soluble inflammatory mediators using xMAP technology. SLE patients who exhibited disease flare had significantly (p < 0.01) higher levels of BL pro-inflammatory mediators, including Th1, Th2, and Th17-type cytokines compared to NF/SNF SLE patients and HC. Regulatory cytokines, including IL-10 and TGF-Beta were increased (p < 0.01) at BL in SLE patients not exhibiting disease flare (NF/SNF) compared to SLE flare and HC. TNFR family members, TNFRI, TNFRII, Fas, FasL, CD40L, were increased at BL in SLE flare patients. Select serum cytokines and chemokines are elevated in patients before SLE disease flare, providing important pathways to dissect for mechanism for flare, therapeutic selection or development.