chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Lumbar puncture, Medical induction of coma, Nuclear magnetic resonance imaging, Status epilepticus, X-ray
Clinical narrative: Seizure - Status epilepticus hospitalized pediatric ICU for months. Treated with steroids, IVIG, Anti viral meds, antibiotics, AED drugs, medical induced coma.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site reaction, Local reaction
Clinical narrative: Pt had a localized reaction at the site of the injection.
Age: 76.0
Sex: F
Vaccine: FLUX
Symptoms: Blood test, Chest X-ray, Chills, Condition aggravated, Ear pain
Clinical narrative: High blood pressure & heart rate (202/100 & 100), ear ache, chills and fever, fatigue.
Age: 76.0
Sex: F
Vaccine: FLUX
Symptoms: Electrocardiogram, Fatigue, Heart rate increased, Hypertension, Influenza virus test
Clinical narrative: High blood pressure & heart rate (202/100 & 100), ear ache, chills and fever, fatigue.
Age: 76.0
Sex: F
Vaccine: FLUX
Symptoms: Pyrexia, Scan brain, Urine analysis
Clinical narrative: High blood pressure & heart rate (202/100 & 100), ear ache, chills and fever, fatigue.
Age: 5.0
Sex: F
Vaccine: FLUX
Symptoms: Pyrexia, Urticaria
Clinical narrative: Began breaking out in hives and running fever. Has to take prednisone and Benadryl.
Age: 25.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site reaction, Injection site swelling, Muscle spasms
Clinical narrative: A few muscle spasms in upper left arm at 11:00pm and swelling all around top half of left upper arm.
Age: 58.0
Sex: M
Vaccine: FLUX
Symptoms: Injection site pain, Myalgia, Pain
Clinical narrative: Arm was sore by the shot area. Had flu shots before and soreness always quickly went away. Arm still sore now over 1 month later. If arm is by side it is mostly OK. Raise arm and it hurts. Muscles very sore sometimes to the point of sharp pain.
Age: 26.0
Sex: F
Vaccine: FLUX
Symptoms: Abdominal discomfort, Abdominal distension, Chest X-ray, Computerised tomogram, Eye swelling
Clinical narrative: Swollen eyes, full feeling, uncomfortable in abdomen, night sweats, itchy hands and feet.
Age: 26.0
Sex: F
Vaccine: FLUX
Symptoms: Full blood count, Night sweats, Pruritus, Ultrasound scan, Urine analysis
Clinical narrative: Swollen eyes, full feeling, uncomfortable in abdomen, night sweats, itchy hands and feet.
Age: 38.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Decreased appetite, Diarrhoea, Dizziness, Gastrointestinal pain
Clinical narrative: Fever, body aches throughout body, severe intestinal cramping, diarrhea, nausea and lost of appetite, drowsiness, dizziness, weakness.
Age: 38.0
Sex: F
Vaccine: PPV
Symptoms: Nausea, Pain, Pyrexia, Somnolence
Clinical narrative: Fever, body aches throughout body, severe intestinal cramping, diarrhea, nausea and lost of appetite, drowsiness, dizziness, weakness.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Dyspnoea
Clinical narrative: The patient had breathing problems and came back to store. He is an MD, and said it was not anaphylaxis. He had another episode at store 20 minutes later. He took 2 BENADRYL and was symptom free for 40 minutes before he left the store.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Itching, swelling and good redness of left deltoid covering about 30 cm diameter area. Much improved (actually resolved) in 24 hours with 2 doses of Benadryl and within 18 hours of Keflex.
Age: 23.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Pain in extremity
Clinical narrative: After receiving the flu shot the patient's arm was sore and bruised. The following Monday the pain in her arm was worse. Had a sharp pain. She went to the doctor's and received prednisone.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Skin warm
Clinical narrative: Redness of arm about 3 inch in diameter, hot.
Sex: F
Vaccine: MMR
Symptoms: Expired drug administered
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age. On 04-DEC-2013 the patient was vaccinated with MMR II lot # 1885AA and expiry date 30-NOV-2013. The patient was administered expired vaccine. This is 1 of 2 reports from same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from the nurse, reported that PROQUAD (lot # J004321, Expiration date 17-OCT-2014) and VARIVAX (Merck) (captured in MARRS# 1311USA002616) went through unsupported temperature excursion on 26-JUN-2013, 01-JUL-2013, 22-JUL-2013 thru 31-JUL-2013 and the entire month of August 2013. On 28-AUG-2013 one patient (age and gender not reported) was administered the unsupported PROQUAD (dose and route not reported). No adverse effects reported. This is one of several reports received from the same source (MAARS# 1311USA012185, 1312USA003400, 1312USA003401, 1312USA003306, 1312USA003307, 1312USA003308, 1312USA003309, 1312USA003310, 1312USA003311, 1312USA003312, 1312USA003313, 1312USA003314, 1312USA003315, 1312USA003316, 1312USA003317). Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This report has been received from the nurse reported that VARIVAX (Merck) (lot# H020587, expiration date 13-NOV-2014) and PROQUAD (MARRS# 1311USA012185) were through unsupported temperature excursions on 26-JUN-2013, 01-JUL-2013, 22-JUL-2013 thru 31-JUL-2013 and the entire month of August 2013. On 26-AUG-2013 the patient was administered the unsupported VARIVAX (Merck) (dose and route not reported). No adverse effects reported. This is one of several reports received from the same source (MARRS# 1311USA002616, 1312USA003307, 1312USA003308, 1313USA003309, 1312USA003306, 1312USA003311, 1312USA003312, 1312USA003313, 1312USA003314, 1312USA003315, 1312USA003316, 1312USA003317, 1312USA003399, 1312USA003400, 1312USA003401). Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from the nurse, reported that PROQUAD (Merck) (lot # J004321, Expiration date 17-OCT-2014) and VARIVAX (Merck) (capture in MARRS#1311USA002616) went through unsupported temperature excursion on 26-JUN-2013, 01-JUL-2013, 01-JUL-2013, 22-JUL-2013 thru 21-JUL-2013 and the entire month of August 2013. On 11-SEP-2013 one patient (age and gender not reported) was administered the unsupported PROQUAD (Merck) (dose and route not reported). No adverse effects reported. This is one of several reports received from the same source (MARRS# 1311USA012185, 1312USA003400, 1312USA003399, 1311USA002616, 1312USA003306, 1312USA003307, 1312USA003308, 1312USA003309, 1312USA003310, 1310USA003311, 1312USA003312, 1312USA003313, 1312USA003314, 1312USA003315, 1312USA003316, 1312USA003317). Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from the nurse, reported that PROQUAD (lot # J004321, Expiration date 17-OCT-2014 and VARIVAX (Merck (captured in MARRS# 1311USA002616) went through unsupported temperature excursion on 26-JUN-2013, 01-JUL-2013, 22-JUL-2013 thru 31-JUL-2013 and the entire month of August 2013. On 04-SEP-2013 one patient (age and gender not reported) was administered the unsupported PROQUAD (dose and route not reported). No adverse effects reported. This is one of several reports received from the same source (MARRS# 1311USA012185, 1312USA003399, 1312USA003401, 1312USA003306, 1312USA003307, 1312USA003308, 1312USA003309, 1312USA003310, 1312USA003311, 1312USA003312, 1312USA003313, 1312USA003314, 1312USA003315, 1312USA003316, 1312USA003317). Additional information has been requested.
Age: 41.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This spontaneous report as received from a certified medical assistant concerning a 41 year old female patient with rheumatoid arthritis. On 19-NOV-2013, the patient was vaccinated with a dose of ZOSTAVAX (route, dose and lot # not reported). Concomitant therapies included Naproxen, Plaquenil, Prednisone (manufacturer unknown) and isoniazid. The medical assistant reported that on 19-NOV-2013, the patient started to experience burning sensation at the injections site. The patient was still experiencing the burning sensation at the injections site. Additional information has been requested.
Age: 0.3
Sex: U
Vaccine: RV5
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant concerning a 12 week old patient. The Certified Medical Assistant reported that on 02-DEC-2013, the patient was vaccinated with a dose of ROTATEQ (lot # H10063; expiration date 02-NOV-2013), 2 ml one dose, oral. No adverse effect was reported. Patient's outcome was unknown. Additional information has been requested.
Age: 14.0
Sex: M
Vaccine: HPV4
Symptoms: Heart rate increased
Clinical narrative: This spontaneous report as received from a physician via Company Representative concerning a 14 year old male patient diabetic and bipolar. On 15-JUL-2011, the patient was vaccinated with the first dose of GARDASIL, intramuscular (dose, lot # and expiration date not reported). On 11-OCT-2011, the patient was vaccinated with the second dose of GARDASIL, intramuscular (dose, lot # and expiration date not reported). On 02-APR-2012, the patient was vaccinated with the third dose of GARDASIL, intramuscular (dose, lot # and expiration date not reported). It was reported that the patient developed increased heart rate after use with GARDASIL. Patient presented in the office on 14-NOV-2013, however, it was unknown if this was the specific start date of the symptoms. Patient's outcome was unknown. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report has been received from a pharmacist concerning to a patient of unknown age and gender. Current conditions, medical history and drug reactions/allergies were not reported. On 09-OCT-2013, the patient was vaccinated with the first dose of RECOMBIVAX HB 1 ml, intramuscular (lot# and expiration date were not reported). Concomitant medication was not reported. On 02-DEC-2013, the patient who received the first dose of RECOMBIVAX HB came to receive his second dose which was outside of recommended dosing interval. No adverse effects reported. Additional information has been requested.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Erythema, Pruritus, Skin warm
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 58 year old female patient. Patient had no pertinent medical history and no drug reactions/allergies. On 29-NOV-2013 the patient was vaccinated with ZOSTAVAX (.065 ml, once, subcutaneous) (lot # J006157, expiry date: 30-AUG-2014) (Physician recommended). There were no concomitant medications. Within 24 hours after receiving ZOSTAVAX, the patient developed a reddened area of skin that grew in size and was pink beyond the reddened area. The patient also reported that the area was warm to the touch. The patient sought medical attention by seeing a physician on 01-DEC-2013, who told her to use ice and prescribed Hydrocortisone, oral Benadryl and Cephalexin. The patient called the pharmacist on 03-DEC-2013 to report that the spreading was contained but the area is not itching and burning. The pharmacist stated that the patient had no hives, bumps, lesions or pustules present. The patient reported to the pharmacist that it looks like sunburn. No lab diagnostic studies were performed. No PQC was involved. Additional information has been requested.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 79 year old male patient with allergy to all mycins and peripheral neuropathy. The patient's medical history included spinal stenosis s/p cervical laminectomy in 2000. On an unspecified date in 2007 the patient was vaccinated with ZOSTAVAX (dose, route, lot number and expiration date not reported). Concomitant therapies included metoprolol, FLOMAX, simvastatin (manufacturer unknown) and aspirin (manufacturer unknown). On 20-NOV-2013 the patient was diagnosed with shingles. The patient sought for medical attention and was seen in office visit, patient was found to have lesions on the left side of his back radiating to the left abdomen. No lab diagnostic studies were performed. VALTREX was the treatment given for the event. The outcome of the event was not recovered. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a Certified Medical Assistant concerning a patient of unknown age and gender. On 22-NOV-2013 the patient was vaccinated with the third dose of GARDASIL (dose, route, lot number and expiration date not reported). It was reported that the patient received the first two doses of GARDASIL at another facility two or three years ago (approximately in 2010). No adverse event was reported. Patient's outcome was unknown. Additional information is not expected.
Age: 4.0
Sex: F
Vaccine: PPV
Symptoms: Antibody test negative
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a 4 year old female patient. Patient with unspecified immunodeficiency disorder. On an unknown date the patient was vaccinated with PNEUMOVAX23 (dose, route, lot number and expiration date not reported). There was no concomitant medication reported. The physician reported that the patient initially had positive antibody titers after administration of PNEUMOVAX23. The antibody titers were rechecked on an unspecified date and the titers were negative. The patient sought for medical attention and visit office. The outcome of the event was unknown. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This report has been received from the nurse reported that VARIVAX (Merck) (lot# H020587, expiration date 13-NOV-2014) and PROQAD (MARRS# 1311USA012185) were through unsupported temperature excursions on 26-JUN-2013, 01-JUL-2013, 22-JUL-2013 thru 31-JUL-2013 and the entire month of August 2013. On 27-SEP-2013 the patient (age and gender not reported) was administerd the unsupported VARIVAX (Merck) (dose and route not rpeorted). No adverse effects reported. This is one of several reports received from the same source (MARRS# 1311USA002616, 1312USA003307, 1312USA003308, 1312USA003309, 1312USA003306, 1312USA003310, 1312USA003312, 1312USA003313, 1312USA003314, 1312USA003315, 1312USA003316, 1312USA003311, 1312USA003399, 1312USA003400, 1312USA003401). Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This report has been received from the nurse reported that VARIVAX (Merck) (lot# H020587, expiration date 13-NOV-2014) and PROQUAD (Merck) (MARRS# 1311USA012185) were trough unsupported temperature excursions on 26-JUN-2013, 01-JUL-2013, 22-JUL-2013 thru 31-JUL-2013 and the entire month of August 2013. On 26-SEP-2013 the patient (age and gender not reported) was administered the unsupported VARIVAX (Merck) (dose and route not reported). No adverse effects reported. This is one of several reports received from the same source (MARRS# 1311USA002616, 1312USA003307, 1312USA003308, 1312USA003309, 1312USA003306, 1312USA003310, 1312USA003312, 1312USA003313, 1312USA003314, 1312USA003315, 1312USA003311, 1312USA003317, 1312USA003399, 1312USA003400, 1312USA003401).
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacy student refers to an unknown number of patients (demographics not provided). On an unknown date the patients were vaccinated with unsupported PNEUMOVAX23 (dose, route, lot number and expiration date not reported). There was no concomitant medication reported. No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This report has been received from the nurse reported that VARIVAX (Merck) (lot# H020587, expiration date 13-NOV-2014) and PROQUAD (MARRS# 1311USA012185) were through unsupported temperature excursions on 26-JUN-2013, 01-JUL-2013, 22-JUL-2013 thru 31-JUL-2013 and the entire month of August 2013. On 20-SEP-2013 the patient (age and gender not reported) was administered the unsupported VARIVAX (Merck) (dose and route not reported). No adverse effects reported. This is one of several reports received from the same source (MARRS# 1311USA002616, 1312USA003307, 1312USA003308, 1313USA003309, 1312USA003306, 1312USA003310, 1312USA003312, 1312USA003313, 1312USA003314, 1312USA003315, 1312USA003316, 1312USA003317, 1312USA003399, 1312USA003400, 1312USA003401). Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This report has been received from the nurse reported that VARIVAX (Merck) (lot# H020587, expiration date 13-NOV-2014) and PROQUAD (Merck) (MARRS# 1311USA012185) were through unsupported temperature excursions on 26-JUN-2013, 01-JUL-2013, 22-JUL-2013 thru 31-JUL-2013 and the entire month of August 2013. On 05-SEP-2013 the patient (age and gender not reported) was administered the unsupported VARIVAX (Merck) (dose and route not reported). No adverse effects reported. This is one of several reports received from the same source (MARRS# 1311USA002616, 1312USA003307, 1312USA003308, 1313USA003309, 1312USA003306, 1312USA003310, 1312USA003312, 1312USA003311, 1312USA003314, 1312USA003315, 1312USA003316, 1312USA003317, 1312USA003399, 1312USA003400, 1312USA003401). Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This report has been received from the nurse reported that VARIVAX (Merck) (lot# H020587, expiration date 13-NOV-2014) and PROQUAD (Merck) (MARRS# 1311USA012185) were trough unsupported temperature excursions on 26-JUN-2013, 01-JUL-2013, 22-JUL-2013 thru 31-JUL-2013 and the entire month of August 2013. On 04-SEP-2013 two patients (age and gender not reported). No adverse effects reported. This is one of several reports received from the same source (MARRS# 1311USA002616, 1312USA003307, 1312USA003308, 1312USA003309, 1312USA003306, 1312USA003310, 1312USA003312, 1312USA003313, 1312USA003314, 1312USA003315, 1312USA003316, 1312USA003317, 1312USA003399, 1312USA003400, 1312USA003401).
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This report has been received from the nurse reported that VARIVAX (merck) (lot# H020587, expiration date 13-NOV-2014) and PROQUAD (merck) (MARRS# 1311USA012185) were trough unsupported temperature excursions on 26-JUN-2013, 01-JUL-2013, 22-JUL-2013 thru 31-JUL-2013 and the entire month of August 2013. On 16-SEP-2013 two patients (age and gender not reported) were administered the unsupported VARIVAX (merck) (dose and route not reported). No adverse effects reported. This is one of several reports received from the same source (MARRS# 1311USA002616, 1312USA003307, 1312USA003308, 1312USA003309, 1312USA003306, 1312USA003310, 1312USA003312, 1312USA003313, 1312USA003311, 1312USA003315, 1312USA003316, 1312USA003317, 1312USA003399, 1312USA003400, 1312USA003401). Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This report has been received from the nurse reported that VARIVAX (Merck) (lot # H020587, expiration date 13-NOV-2014) and PROQUAD (Merck) (MARRS# 1311USA012185) were trough unsupported temperature excursions on 26-JUN-2013, 01-JUL-2013, 22-JUL-2013 thru 31-JUL-2013 and the entire month of August 2013. On 23-AUG-2013 the patient was administered the unsupported VARIVAX (Merck) (dose and route not reported). This is one of several reports received from the same source (MARRS# 1311USA002616, 1312USA003307, 1312USA003308, 1312USA003306, 1312USA003310, 1312USA003311, 1312USA003312, 1312USA003313, 1312USA003314, 1312USA003315, 1312USA003316, 1312USA003317). Additional information is not expected.
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age. On 04-DEC-2013 the patient was vaccinated with MMR II lot # 1885AA and expiry date 30-NOV-2013. The patient was administered expired vaccine. This is 2 of 2 reports from same reporter. Additional information has been requested.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Pain in extremity, Rash
Clinical narrative: This spontaneous report as received from a pharmacist refers to an 82 year old female patient. The patient has no drug reactions/allergies. On 08-NOV-2013 the patient was vaccinated with ZOSTAVAX lot number J002865 expiry date 07-JUN-2014, 1 vial, via subcutaneous route in the upper left arm to prevent shingles. On an unknown date in approximately November 2013 after vaccination, the patient developed a rash and severe pain on her right upper thigh. The patient was diagnosed with shingles during an office visit with her physician on 15-NOV-2013 and was prescribed Percocet, Ibuprofen (manufacturer unknown) and Valacyclovir (manufacturer unknown). On 21-NOV-2013, the patient had an office visit with another physician who had prescribed Valacyclovir (manufacturer unknown), Neurontin and a higher strength of Percocet. The patient continued to have severe pain especially at night time. The outcome of events shingles and rash was reported as resolving. The outcome of severe pain on her right upper thigh was not resolved. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Activities of daily living impaired, Blood glucose normal, Chest X-ray normal, Dizziness, Dyspnoea
Clinical narrative: This spontaneous report as received from a pharmacist refers to her 14 year old daughter. On an unspecified date in August 2013, the patient was vaccinated with the first dose of GARDASIL (lot #, expiration date, dose, frequency and route not reported) to prevent human papillomavirus (HPV). There were no concomitant medications, pertinent medical history and drug reactions or allergies. On unknown date in 2013, the patient had been experiencing syncope, dizziness, nausea, migraine headaches and difficulty breathing. These symptoms started approximately 2 weeks after the patient received GARDASIL. The patient was seen by an unspecified neurologist. The outcome of the events was not recovered. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Electrocardiogram normal, Full blood count normal, Headache, Loss of consciousness, Nausea
Clinical narrative: This spontaneous report as received from a pharmacist refers to her 14 year old daughter. On an unspecified date in August 2013, the patient was vaccinated with the first dose of GARDASIL (lot #, expiration date, dose, frequency and route not reported) to prevent human papillomavirus (HPV). There were no concomitant medications, pertinent medical history and drug reactions or allergies. On unknown date in 2013, the patient had been experiencing syncope, dizziness, nausea, migraine headaches and difficulty breathing. These symptoms started approximately 2 weeks after the patient received GARDASIL. The patient was seen by an unspecified neurologist. The outcome of the events was not recovered. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Urine analysis normal
Clinical narrative: This spontaneous report as received from a pharmacist refers to her 14 year old daughter. On an unspecified date in August 2013, the patient was vaccinated with the first dose of GARDASIL (lot #, expiration date, dose, frequency and route not reported) to prevent human papillomavirus (HPV). There were no concomitant medications, pertinent medical history and drug reactions or allergies. On unknown date in 2013, the patient had been experiencing syncope, dizziness, nausea, migraine headaches and difficulty breathing. These symptoms started approximately 2 weeks after the patient received GARDASIL. The patient was seen by an unspecified neurologist. The outcome of the events was not recovered. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Dizziness, Dyspnoea, Migraine, Nausea, Syncope
Clinical narrative: This spontaneous report as received from a pharmacist refers to her 14 year old daughter. On an unspecified date in August 2013, the patient was vaccinated with the first dose of GARDASIL (lot #, expiration date, dose, frequency and route not reported) to prevent human papillomavirus (HPV). There were no concomitant medications, pertinent medical history and drug reactions or allergies. On unknown date in 2013, the patient had been experiencing syncope, dizziness, nausea, migraine headaches and difficulty breathing. These symptoms started approximately 2 weeks after the patient received GARDASIL. The patient was seen by an unspecified neurologist. The outcome of the events was not recovered. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Intensive care, Loss of consciousness, Respiratory failure
Clinical narrative: Pt contacted pharmacy 11/6/13 stating she had experienced "passing out" episodes. Pt wondered if due to PNEUMOVAX -23 received by pt 11/5/13. Pt went to local ER 11/9/13. Pt was admitted to ICU in larger facility 11/9/13. (Symptoms Respiratory Failure).
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site nodule, Injection site swelling, Local reaction, Pruritus
Clinical narrative: Patient had a localized raction of a large not developing at injection site, redness and swelling of arm that spread to elbow from middle of upper arm. Her doctor prescribed BENADRYL for itching and Clindamycin.
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Hyperaesthesia, Muscle tightness, Pain of skin, Sensation of heaviness
Clinical narrative: Muscle tightness all over body. Sensitive/ hurting skin all over. Heavy and drained of energy. Pain at level 10.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Herpes zoster, Pain, Rash
Clinical narrative: Shingles, on the left breast and going down the left arm. same side as where the vaccine was given. I went to see MD and was started on Valtrex 1000mg three times a day. My body has not been without the painful rash since.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Local swelling
Clinical narrative: Localized swelling to right upper arm.
Age: 33.0
Sex: F
Vaccine: FLUX
Symptoms: Dizziness, Dyspnoea, Urticaria
Clinical narrative: Hives, dizziness, difficulty breathing.
Age: 59.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site pain, Musculoskeletal pain, Pain
Clinical narrative: About 1-2 hours after the vaccine, my arm (at site of shot) and shoulder began to hurt - extreme soreness.  After 4 or 5 days the pain at the site went away but the pain in my shoulder/joint of arm has never gone away.  Pain when moving the arm in certain positions.  On a scale of 1-10, 10 being the worst pain, it's a 3 or 4, depending on how the arm is used.  I have not been to my doctor, as I kept thinking it would go away with time.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Erythema, Skin infection, Soft tissue infection
Clinical narrative: Patient received ZOSTAVAX shot 12/3/13 and developed pain in his elbow in the morning of 12/4/13. By 12/5/13 he developed a 4x6 circular red patch on elbow. He went to his primary doctor and was prescribed Cephalexin for a skin/tissue infection.
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Musculoskeletal stiffness
Clinical narrative: Pt was administered FLUARIX Quad on 11/13/13. On 12/5/13 was still complaining of stiff arm no warm or redness at site.
Age: 65.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Local swelling, Pyrexia, Skin warm
Clinical narrative: Patient right arm warm, red and swollen. Pt running low grade fever. Pt called pharmacy 12/6 I advised pt to contact MD due to reaction. Pt visit dr and antibiotic ordered. Called pt 12/8, fever down still some redness/swelling.
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Arthritis, Immediate post-injection reaction, Menstruation irregular, Night sweats
Clinical narrative: This spontaneous report as received from a consumer refers to her daughter, a female patient of unknown age with no pertinent medical history or drug reactions/allergies. On an unknown date in June 2013 ("5 months ago") the patient was vaccinated with first dose of GARDASIL (lot#, expiration date, dose, route not reported). There was no concomitant medication. On an unknown date in 2013 ("immediately after the shot") the patient began to experience "night sweats", irregular menstrual bleeding where previously it was regularly, and joint pain, particularly in her lower back. The patient went to the orthopedist, who performed an MRI. The physician diagnosed the daughter with arthritis and wanted to begin steroid injections, but the mother refused any injections. The patient had not received any treatment at the time of the report. The outcome of the events was reported as not recovered. This is one of several reports received from same source. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Nuclear magnetic resonance imaging
Clinical narrative: This spontaneous report as received from a consumer refers to her daughter, a female patient of unknown age with no pertinent medical history or drug reactions/allergies. On an unknown date in June 2013 ("5 months ago") the patient was vaccinated with first dose of GARDASIL (lot#, expiration date, dose, route not reported). There was no concomitant medication. On an unknown date in 2013 ("immediately after the shot") the patient began to experience "night sweats", irregular menstrual bleeding where previously it was regularly, and joint pain, particularly in her lower back. The patient went to the orthopedist, who performed an MRI. The physician diagnosed the daughter with arthritis and wanted to begin steroid injections, but the mother refused any injections. The patient had not received any treatment at the time of the report. The outcome of the events was reported as not recovered. This is one of several reports received from same source. Additional information is not expected.
Sex: M
Vaccine: HPV4
Symptoms: Agitation, Alopecia, Arthralgia, Cough, Mood altered
Clinical narrative: This spontaneous report as received from a consumer refers to a male patient of unknown age with no pertinent medical history or drug reactions/allergies. On an unknown date and approximately in June 2013 ("5 months ago") the patient was vaccinated with first and second doses of GARDASIL (lot #, expiration date, dose, route not reported) for immunization., There was no concomitant medication. The patient received his first dose of GARDASIL and developed a sore throat three days after, and had a "personality change" of moodiness and agitations. The patient received the second dose "five months ago" and since then had experienced painful joints in knees, elbows and shoulders, a "weird" cough and the patient got recurrent sinus and nasal infections where he did not have them before receiving GARDASIL. The consumer stated that after the second shot he started to experience hair loss as well. It began by receding on the left side of the hairline and he had experienced hair loss all over the scalp in the last five months. The patient had not received any treatment at the time of the report. The outcome of the event was reported as not recovered. This is one of several reports received from same source. Additional information is not expected.
Sex: M
Vaccine: HPV4
Symptoms: Oropharyngeal pain, Personality change, Rhinitis, Sinusitis
Clinical narrative: This spontaneous report as received from a consumer refers to a male patient of unknown age with no pertinent medical history or drug reactions/allergies. On an unknown date and approximately in June 2013 ("5 months ago") the patient was vaccinated with first and second doses of GARDASIL (lot #, expiration date, dose, route not reported) for immunization., There was no concomitant medication. The patient received his first dose of GARDASIL and developed a sore throat three days after, and had a "personality change" of moodiness and agitations. The patient received the second dose "five months ago" and since then had experienced painful joints in knees, elbows and shoulders, a "weird" cough and the patient got recurrent sinus and nasal infections where he did not have them before receiving GARDASIL. The consumer stated that after the second shot he started to experience hair loss as well. It began by receding on the left side of the hairline and he had experienced hair loss all over the scalp in the last five months. The patient had not received any treatment at the time of the report. The outcome of the event was reported as not recovered. This is one of several reports received from same source. Additional information is not expected.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Extensive swelling of vaccinated limb, Injection site erythema
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 67 year old female patient with asthma. The patient has unspecified reactions to codeine and tetracycline. On 22-NOV-2013 the patient was vaccinated with PNEUMOVAX23 lot # J004196 (exp06-DEC-2014), 0.5 ml once, intramuscular in the left arm for having asthma. Concomitant therapies included Diazepam (manufacturer unknown), pantoprazole and Qvar. The pharmacist reported that after the patient received PNEUMOVAX23, she experienced redness at the injections site and swelling of the "entire" injected arm. The patient received the vaccine in the left arm. Event onset date was unspecified. The pharmacist reported that the patient came back into the pharmacy on 23-NOV-2013 to report this reaction. No treatment was given. No lab test was done. Outcome of the event was unknown. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Hyperaesthesia, Muscle tightness, Pain of skin
Clinical narrative: Skin hurt and very sensitive. Muscles tensed up and felt like I lost all energy. Had to be driven home and layed to rest.
Age: 24.0
Sex: F
Vaccine: FLUN3
Symptoms: Asthenia, Muscle spasms, Muscle tightness, Pain
Clinical narrative: Drained of energy and muscle crampness. Had to sleep off the pain. Felt sore next day from the muscle tenstion.
Age: 1.11
Sex: F
Vaccine: MMR, VARCEL, MMR, VARCEL
Symptoms: Unevaluable event
Clinical narrative: Mother noticed small, warm, induration on her left thigh 9/2/13. On 9/4/13 she came in and per mom it was bigger Dr. noticed a 3 cm diameter erythematous, warm, indurated area w/o fluctuation or discharge.
Age: 1.11
Sex: F
Vaccine: MMR, VARCEL, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Mother noticed small, warm, induration on her left thigh 9/2/13. On 9/4/13 she came in and per mom it was bigger Dr. noticed a 3 cm diameter erythematous, warm, indurated area w/o fluctuation or discharge.
Age: 1.01
Sex: F
Vaccine: FLU4, HEPA, MMRV, FLU3, HEPA, MMRV
Symptoms: Injection site rash
Clinical narrative: Rash on thigh. Small cluster of pink papules. No warmth, or pain to palpation. No signs of cellulitis. Call office if fever, inc. pain, swelling, symptoms worsen. Anticipatory guidance given.
Age: 1.01
Sex: F
Vaccine: FLU4, HEPA, MMRV, FLU3, HEPA, MMRV
Symptoms: Injection site rash, Rash papular
Clinical narrative: Rash on thigh. Small cluster of pink papules. No warmth, or pain to palpation. No signs of cellulitis. Call office if fever, inc. pain, swelling, symptoms worsen. Anticipatory guidance given.
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Incorrect route of drug administration, Injection site swelling, Injection site warmth, Paraesthesia
Clinical narrative: Persistent redness and swelling at injection site (for 2 weeks after injection) and "burning sensation" in forearm and pinky finger for several days after injection.
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Burning sensation, Injection site erythema, Injection site swelling
Clinical narrative: Persistent redness and swelling at injection site (for 2 weeks after injection) and "burning sensation" in forearm and pinky finger for several days after injection.
Age: 75.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Eye pain, Headache, Rash, Rash papular
Clinical narrative: Headache, papular rash on face, pain posterior to eye.
Age: 75.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Headache, Herpes zoster, Mass, Rash
Clinical narrative: Headache, papular rash on face, pain posterior to eye.
Age: 48.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood test, Computerised tomogram, Herpes zoster, Pruritus, Radial nerve palsy
Clinical narrative: This spontaneous report as received from a 48 year old female consumer with no drug reactions/allergies. The patient's medical history included that the patient may have had a case of shingles before receiving ZOSTAVAX. On 04-NOV-2013, the patient was vaccinated with a dose of ZOSTAVAX (route reported as injection, lot#/expiry date not reported) as recommendation from doctor. Concomitant therapies included SYNTHROID, estrogens, CYMBALTA and LYRICA. On 05-NOV-2013, the patient developed a mild case of shingles that involved her being itchy and a rash breaking out after receiving ZOSTAVAX, the patient also reported she went to the emergency room for radial nerve palsy of her left wrist after receiving ZOSTAVAX. The patient sought medical attention (doctor's visit). On an unspecified date, X-ray, blood work and CT scan were performed and the results were not reported. There was no treatment received for the adverse events. The outcomes of the events were reported as not recovered/not resolved. Upon internal review the event radial nerve palsy considered to be medically significant. Additional information has been requested.
Age: 48.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, X-ray
Clinical narrative: This spontaneous report as received from a 48 year old female consumer with no drug reactions/allergies. The patient's medical history included that the patient may have had a case of shingles before receiving ZOSTAVAX. On 04-NOV-2013, the patient was vaccinated with a dose of ZOSTAVAX (route reported as injection, lot#/expiry date not reported) as recommendation from doctor. Concomitant therapies included SYNTHROID, estrogens, CYMBALTA and LYRICA. On 05-NOV-2013, the patient developed a mild case of shingles that involved her being itchy and a rash breaking out after receiving ZOSTAVAX, the patient also reported she went to the emergency room for radial nerve palsy of her left wrist after receiving ZOSTAVAX. The patient sought medical attention (doctor's visit). On an unspecified date, X-ray, blood work and CT scan were performed and the results were not reported. There was no treatment received for the adverse events. The outcomes of the events were reported as not recovered/not resolved. Upon internal review the event radial nerve palsy considered to be medically significant. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist concerning a patient of unknown age and gender. On 22-NOV-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot # J003483; expiration date 29-JUN-2014), 0.65 ml, subcutaneous. The pharmacist reported that she administered dose of ZOSTAVAX (that was not supported in a temperature excursion) to a patient. No adverse effects were reported. Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative refers to a patient of unknown age. Approximately in 2012 (reported as approximately 1 year ago) the patient was vaccinated with ZOSTAVAX dose unknown for shingles prevention. No concomitant medications were reported. Approximately in 2012, 5 days after receiving vaccination the patient returned to the pharmacy as the patient had experienced unspecified rash. The pharmacist stated the rash as mile to moderate. The outcome of rash is unknown. 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 certified professional in healthcare quality (CPHQ) refers to an unspecified number of patients of unknown age (gender not reported) who may have been administered a dose (doses) of PNEUMOVAX23 (dose, route, lot number not reported) which went out of temperature range (unknown) for an unspecified amount of time. No adverse effects have been reported. Additional information has been requested.
Age: 67.0
Sex: M
Vaccine: HEPA
Symptoms: Laceration, No adverse event, Syringe issue
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 67 year old male physician. On 05-DEC-2013 a patient was vaccinated with VAQTA (lot number reported a J011712; expiry date 21-SEP-2015). No concomitant medications were reported. On 05-DEC-2013, while finishing administering VAQTA dose to an anonymous patient with a VAQTA prefilled syringe, the barrel of the syringe broke. No unusual force was exerted on the syringe and the patient was behaving. The breakage happened just as the dose was finished being injected, but before the syringe needle was removed from the patient. The patient did receive the full dose of VAQTA. No known adverse effects to the patient. The broken glass of the syringe made a 3/8th inch cut on the physician's middle finger of his right hand. The physician was not sure if some VAQTA got into the cut. The physician washed out the cut but the cut was still bleeding. PQC was filed for the broken VAQTA prefilled syringe. No treatment was provided for the event. The physician did not sought medical attention. The outcome of the event cut in the middle finger and bleeding was not recovered. Additional information has been requested.
Age: 1.7
Sex: M
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a 20 month old male patient. On an unknown date the patient was vaccinated with a dose of VARIVAX (lot#, dose, route, strength and indications not reported). The patient appeared to have a developed a "Shingles rash" in November 2013 (now). The patient sought medical attention by office visit. The physician conducted titer tests and was awaiting results. At the time of reporting, the outcome of "shingles rash" was unknown. Additional information has been requested.
Age: 43.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Neuralgia
Clinical narrative: This spontaneous report as received from a consumer refers to a 43 year old female patient with a history shingles in the past. The patient is allergic a Vicatin, Demoral, Amoxicillin and Sulfa. On 28-OCT-2013 the patient was vaccinated with ZOSTAVAX (dosing information and route were not provided). Concomitant therapies included Valtrax. Since 01-NOV-2013, the patient has had 3 episodes of shingles. The first episode of shingles lasted a few days, consisted of minor blisters with minor nerve pain. The second breakout was worse, consisted of the blisters and the nerve pain was a more intense. The third breakout is extreme blistering and intense nerve pain. Usually shingles came in the same area, on her stomach area. The third breakout was on her back. No treatment was provided. The outcome of second and the third breakout of shingles is unknown. Reporter causality was not provided. No reporter details available. Additional information is not expected.
Age: 6.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: This spontaneous report as received from a nurse via a company representative refers to an 8 year old male child. On 05-SEP-2006, the patient was vaccinated with VARIVAX lot number either 0419R or 0788R dose 1 for vaccination. On 19-JAN-2012 the patient was vaccinated with VARIVAX lot # 0863AA, expiration date 06-JUN-2013 dose 2 for vaccination. No concomitant medications were reported. On 29-NOV-2013, the patient experienced varicella rash. The patient sought medical attention and was diagnosed with a mild case of chicken pox (50-500 lesions) on 03-DEC-2013 by the physician. The outcome of chickenpox was reported as not recovered/not resolved. Additional information has been requested.
Age: 18.0
Sex: M
Vaccine: FLUX, HPV4
Symptoms: Presyncope, Skin discolouration, Unresponsive to stimuli
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to an 18 year old male patient with no medical history and no drug reactions/allergies. On 18-NOV-2013 the patient was vaccinated with the first dose of GARDASIL (typical dose and typical route). Nurse practitioner mentioned a patient was given the first dose of GARDASIL while sitting in a chair and the patient's face turned pale yellow/green and the patient would not respond to any questions and eyes were still open - the patient almost fainted. The patient was given an unspecified flu vaccine (manufacturer unknown and AFLURIA could not be ruled out) on the same day as GARDASIL but the patient had received this flu vaccine in the past with no problems. Concomitant therapies included TOPAMAX. Laboratory studies performed included vital signs such as blood pressure and pulse. The patient was placed on his back on a table and legs were elevated. The patient was still in the office. The outcome of event was reported as recovered/resolved on 18-NOV-2013. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This spontaneous report as received from a female consumer of unknown age refers to herself. On an unknown date the patient was vaccinated with ZOSTAVAX (lot#, dose, frequency unspecified). On an unknown date the patient reported that her rash had not gone away yet. The outcome of the event was unknown. 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 registered nurse refers to a patient of unknown age. Approximately on an unknown date in December 2012 (reported as a year after) the patient was vaccinated with GARDASIL dose 1. No concomitant medications were reported. On 02-DEC-2013 the patient was vaccinated with GARDASIL dose 2 one year after the first dose. No adverse effect was reported. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a nurse refers to a 64 year old female patient with drug reactions/allergies to Morphine and with no pertinent medical history. On 20-NOV-2013 the patient was vaccinated with a dose of ZOSTAVAX (lot # J006828, expiration date 14-SEP-2014), dose not reported, subcutaneous to prevent shingles. Concomitant therapies included Tylenol, Losartan potassium (manufacturer unknown), Ibuprofen, fish oil, Simvastatin (manufacturer unknown), Ubidecarenone, calcium (unspecified) and multivitamin. On 24-NOV-2013, the patient experienced shingles after received ZOSTAVAX. No lab diagnostics studies were performed. The treatments of Famciclovir and hydrocodone were given to the event. The outcome of the event was reported as not recovered. The patient had sought medical attention by office visit. Additional information has been requested.