chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Abdominal pain, Aphthous stomatitis, Chills, Constipation, Decreased appetite
Clinical narrative: Central nervous system: Chills, fatigue, fever, headache, irritability, malaise, nervousness, sleep disturbance. Dermatologic: Contact rash, dermatitis, diaper rash, dry skin, eczema, generalized varicella-like rash, heat rash, itching, urticaria. Gastrointestinal: Abdominal pain, appetite decreased, cold/canker sore, constipation, diarrhea, nausea, vomiting. Hematologic: Lymphadenopathy. Local: Injection site reaction, varicella-like rash at the injection.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Dermatitis, Dermatitis diaper, Diarrhoea, Dry skin, Eczema
Clinical narrative: Central nervous system: Chills, fatigue, fever, headache, irritability, malaise, nervousness, sleep disturbance. Dermatologic: Contact rash, dermatitis, diaper rash, dry skin, eczema, generalized varicella-like rash, heat rash, itching, urticaria. Gastrointestinal: Abdominal pain, appetite decreased, cold/canker sore, constipation, diarrhea, nausea, vomiting. Hematologic: Lymphadenopathy. Local: Injection site reaction, varicella-like rash at the injection.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Fatigue, Headache, Injection site rash, Injection site reaction, Irritability
Clinical narrative: Central nervous system: Chills, fatigue, fever, headache, irritability, malaise, nervousness, sleep disturbance. Dermatologic: Contact rash, dermatitis, diaper rash, dry skin, eczema, generalized varicella-like rash, heat rash, itching, urticaria. Gastrointestinal: Abdominal pain, appetite decreased, cold/canker sore, constipation, diarrhea, nausea, vomiting. Hematologic: Lymphadenopathy. Local: Injection site reaction, varicella-like rash at the injection.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Lymphadenopathy, Malaise, Miliaria, Nausea, Nervousness
Clinical narrative: Central nervous system: Chills, fatigue, fever, headache, irritability, malaise, nervousness, sleep disturbance. Dermatologic: Contact rash, dermatitis, diaper rash, dry skin, eczema, generalized varicella-like rash, heat rash, itching, urticaria. Gastrointestinal: Abdominal pain, appetite decreased, cold/canker sore, constipation, diarrhea, nausea, vomiting. Hematologic: Lymphadenopathy. Local: Injection site reaction, varicella-like rash at the injection.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Oral herpes, Pruritus, Pyrexia, Rash, Rash generalised
Clinical narrative: Central nervous system: Chills, fatigue, fever, headache, irritability, malaise, nervousness, sleep disturbance. Dermatologic: Contact rash, dermatitis, diaper rash, dry skin, eczema, generalized varicella-like rash, heat rash, itching, urticaria. Gastrointestinal: Abdominal pain, appetite decreased, cold/canker sore, constipation, diarrhea, nausea, vomiting. Hematologic: Lymphadenopathy. Local: Injection site reaction, varicella-like rash at the injection.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash vesicular, Sleep disorder, Urticaria, Vomiting
Clinical narrative: Central nervous system: Chills, fatigue, fever, headache, irritability, malaise, nervousness, sleep disturbance. Dermatologic: Contact rash, dermatitis, diaper rash, dry skin, eczema, generalized varicella-like rash, heat rash, itching, urticaria. Gastrointestinal: Abdominal pain, appetite decreased, cold/canker sore, constipation, diarrhea, nausea, vomiting. Hematologic: Lymphadenopathy. Local: Injection site reaction, varicella-like rash at the injection.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Blood test, Dysstasia, Laboratory test, Musculoskeletal pain
Clinical narrative: Pain in shoulder and knee joints, could not stand up from seated position without help. Had to sit up and twist my body so I could turn over when in a prone position. Had slight muscle soreness in biceps, calfs, and swollen hands.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Myalgia
Clinical narrative: Pain in shoulder and knee joints, could not stand up from seated position without help. Had to sit up and twist my body so I could turn over when in a prone position. Had slight muscle soreness in biceps, calfs, and swollen hands.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Periarthritis
Clinical narrative: Frozen Shoulder.  Patient woke up with difficulty moving shoulder.
Age: 2.0
Sex: F
Vaccine: DTAP, FLU3, HEPA, HIBV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Left thigh-swelling, redness, warmth to half of upper thigh. Duration of 48 hours.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Cyanosis, Immediate post-injection reaction, Injection site erythema, Injection site inflammation, Injection site reaction
Clinical narrative: Pt immediately got black and blue at the injection site. Pharmacist contacted patient later in the evening and the patient stated it was red and inflamed. Patient stopped in the pharmacy the next day (Jan 23, 2014 around 4pm) and the injection site was red, warm to the touch, & approx. 2 inches in diameter. Advised the patient to contact MD if the site was painful or it got worse.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth
Clinical narrative: Pt immediately got black and blue at the injection site. Pharmacist contacted patient later in the evening and the patient stated it was red and inflamed. Patient stopped in the pharmacy the next day (Jan 23, 2014 around 4pm) and the injection site was red, warm to the touch, & approx. 2 inches in diameter. Advised the patient to contact MD if the site was painful or it got worse.
Age: 13.0
Sex: M
Vaccine: FLU3, MNQ, TDAP, VARCEL
Symptoms: Erythema, Swelling
Clinical narrative: Red and swollen.
Age: 63.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Itchy, swelling, painful, red, warm to the touch at administration site. Approximately 2 centimeters long. Took ibuprofen to relieve symptoms.
Age: 23.0
Sex: M
Vaccine: MNQ
Symptoms: Dizziness, Hypoaesthesia, Muscular weakness
Clinical narrative: Within 5 min after this vaccine, pt felt lightheaded and dizziness, rated 5/10. Also weakness to left foot and shin area, slight numbness- initially rated 8 or 9/10. Laid pt flat, applied cool damp cloth to forehead and neck, and gave orange juice. Full ROM, very slight weakness noted with left foot plantar flexion against resistance, but later strength appeared equal. Pt reported feeling better after 30 min, dizziness gone, very slight lightheadedness. Left LE weakness about 3/10 at 30 min, then 1/10 at 60 min upon leaving clinic. Pt able to walk without difficult, but said foot/lower leg still felt a little strange. As precaution, brother picked up patient to go home. Pt will be with brother for the next few hours.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Abnormal sensation in eye, Burning sensation, Eye pain, Headache, Photopsia
Clinical narrative: Received the "Fluvirin INJ PF 13-14" last night. 28 hours later I began seeing sparks, and then my vision became cloudy like I'm looking through a foggy mirror. Marked vision trouble. Suddenly hurts very much to read and words are blurry. I feel marked pressure behind my eyes, like a mild headache-almost a low burning feeling. A headache is building in intensity. I don't suffer from headaches and I have had perfect vision my entire life and have never experienced any vision-related events or weaknesses previously in my life. (My vision has been tested and I don't wear or need glasses or contacts.) This is totally unusual and came on absolutely suddenly.I have not seen a doctor yet, and will determine whether this is necessary in the morning, if the issue persists. Too me this is very serious as my vision has been perfect my entire life. No other symptoms so far.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Vision blurred
Clinical narrative: Received the "Fluvirin INJ PF 13-14" last night. 28 hours later I began seeing sparks, and then my vision became cloudy like I'm looking through a foggy mirror. Marked vision trouble. Suddenly hurts very much to read and words are blurry. I feel marked pressure behind my eyes, like a mild headache-almost a low burning feeling. A headache is building in intensity. I don't suffer from headaches and I have had perfect vision my entire life and have never experienced any vision-related events or weaknesses previously in my life. (My vision has been tested and I don't wear or need glasses or contacts.) This is totally unusual and came on absolutely suddenly.I have not seen a doctor yet, and will determine whether this is necessary in the morning, if the issue persists. Too me this is very serious as my vision has been perfect my entire life. No other symptoms so far.
Age: 16.0
Sex: F
Vaccine: FLU3, HEPA, MNQ
Symptoms: Exposure during pregnancy, Ultrasound antenatal screen normal
Clinical narrative: Hep A, MCV4, TIV given on 10-21-13. Ultrasound result from 11-14-13 confirmed that patient was 5 weeks, 6 days pregnant, patient stated at time of visit that she was not sexually active.
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Blood pressure increased, Chest X-ray normal, Computerised tomogram head normal, Dry throat, Eyelid oedema
Clinical narrative: Patient reported to office after reporting to covering physician that she took 2 BENADRYL on the advise of her daughter for lips and eyes that feel puffy more, on left side of face. Throat is dry and painful. No trouble breathing, chest tightness or tongue swelling. Covering physician noted elevated BP and left side of face drool and decreased sensation. Sent to Emergency room to r/o allergic reaction vs neurological such as vascular insufficiency, complicated migraine, viral inflammation probably. Pt seen by PCP 1-23-14 Diagnosis Bell's Palsy not related to vaccine.
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Inflammation, Laboratory test normal, Lip swelling, Nuclear magnetic resonance imaging brain normal, Oropharyngeal pain
Clinical narrative: Patient reported to office after reporting to covering physician that she took 2 BENADRYL on the advise of her daughter for lips and eyes that feel puffy more, on left side of face. Throat is dry and painful. No trouble breathing, chest tightness or tongue swelling. Covering physician noted elevated BP and left side of face drool and decreased sensation. Sent to Emergency room to r/o allergic reaction vs neurological such as vascular insufficiency, complicated migraine, viral inflammation probably. Pt seen by PCP 1-23-14 Diagnosis Bell's Palsy not related to vaccine.
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Sensory loss, VIIth nerve paralysis, Viral infection
Clinical narrative: Patient reported to office after reporting to covering physician that she took 2 BENADRYL on the advise of her daughter for lips and eyes that feel puffy more, on left side of face. Throat is dry and painful. No trouble breathing, chest tightness or tongue swelling. Covering physician noted elevated BP and left side of face drool and decreased sensation. Sent to Emergency room to r/o allergic reaction vs neurological such as vascular insufficiency, complicated migraine, viral inflammation probably. Pt seen by PCP 1-23-14 Diagnosis Bell's Palsy not related to vaccine.
Age: 9.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Injection site erythema, Injection site pain, Localised oedema, Skin reaction
Clinical narrative: Influenza vaccination at 9:30 am. Patient noticed erythema and pain at noon (R) deltoid. Patient evaluated at 3 pm. He was noted to have a 9 cm x 6.5 cm of erythema and mild edema consistent with a local skin rxn. Pt was given 25 mg BENADRYL PO and a cool compress applied. VSS. Pt encouraged to monitor for worsening rxn, take OTC ZYRTEC and f/u dr needed.
Age: 6.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site vesicles
Clinical narrative: Red, raised area 8cm, blisters on thighs, left worse than right. Triple antibiotic ointment - change dressings - keep covered.
Age: 11.0
Sex: F
Vaccine: HEP, TDAP, VARCEL
Symptoms: Blister, Erythema, Local swelling, Pruritus, Skin warm
Clinical narrative: Patient experienced red, raised, itchy area 14 cm, warm to touch, forming blisters. Treated for possible cellulitis / cephalexin 500mg 1 cap q 6 hrs.
Age: 19.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Feeling hot, Thirst
Clinical narrative: Approx 15 min after injection became dizzy and hot continued to work. Became thirsty, drank H2O, but didn't feel better. 40 min after injection notified medical staff, laid down in office with feet elevated. Recovered slowly BP 120/80 P 86.
Age: 51.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect dose administered
Clinical narrative: Patient received double dose of flu vaccine. 1st vaccine: 11-12-13 2nd vaccine: 1-16-14.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Unevaluable event
Clinical narrative: Pt stated she had not received ZOSTAVAX before. No adverse reaction. Once patient was informed of 2nd dose, she still believed she hadn't received the first dose.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of an unknown age and gender. On 14-DEC-2012 at 07:45, ZOSTVAX lot # H016765 was exposed to -14 for an estimated total time out of range of 13.25 hours. Last temperature recorded -17. (It was also reported that on 18-DEC-2012 at 18:30 the ZOSTAVAX lot # H016765 was exposed to -14 for an estimated total time out of range of 12.75 hours). Last temperature recorded -16. On 30-NOV-2012, the patient was vaccinated with an out of temperature range dose of ZOSTAVAX (dose and route administration were not provided) (lot # H016765) (dose number was not provided). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of an unknown age and gender. On 14-DEC-2012 at 07:45, ZOSTAVAX lot # H016765 was exposed to -14 for an estimated total time out of range of 13.25 hours. Last temperature recorded -17. (It was also reported that on 18-DEC-2012 at 18:30 the ZOSTAVAX lot # H016765 was exposed to -14 for an estimated total time out of range of 12.75 hours). Last temperature recorded -16. On 03-DEC-2012, the patient was vaccinated with an out of temperature range dose of ZOSTAVAX (dose and route administration were not provided) (lot # H016765) (dose and number was not provided). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of an unknown age and gender. On 14-DEC-2012 at 07:45, ZOSTAVAX lot # H016765 was exposed to -14 for an estimated total time out of range of 13.25 hours. Last temperature recorded -17. (It was also reported that on 18-DEC-2013 at 18:30 the ZOSTAVAX lot # H016765 was exposed to -14 for an estimated total time out of range of 12.75 hours). Last temperature recorded -16. On 05-DEC-2012, the patient was vaccinated with an out of temperature range dose of ZOSTAVAX (dose and route administration were not provided) (lot # H016765) (dose number was not provided). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of unknown age and gender. On 14-DEC-2012 at 07:45, ZOSTAVAX lot # H016765 was exposed to -14 for an estimated total time out of range of 13.25 hours. Last temperature recorded -17. (It was also reported that on 18-DEC-2012 at 18:30 the ZOSTAVAX lot # H016765 was exposed to -14 for an estimated total time out of range of 12.75 hours). Last temperature recorded -16. On 05-DEC-2012, the patient was vaccinated with an out of temperature range dose of ZOSTAVAX (dose and route administration were not provided) (lot # H016765) (dose number was not provided). No adverse experience had been reported. This is of 182 reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of an unknown age and gender. On 14-DEC-2012 at 07:45, ZOSTAVAX lot # H016765 was exposed to -14 for an estimated total time out range of 13.25 hours. Last temperature recorded -17. (It was reported that on 18-DEC-2012 at 18:30 the ZOSTAVAX lot # H016765 was exposed to -14 for an estimated total time out of range of 12.75 hours). Last temperature recorded -16. On 07-DEC-2012, the patient was vaccinated with an out of temperature range dose of ZOSTAVAX (dose and route administration were not provided) (lot # H016765) (dose number was not provided). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of unknown age and gender. On 14-DEC-212 at 07:45, ZOSTAVAX lot # H016765 was exposed to -14 for an estimated total time out of range of 13.25 hours. Last temperature recorded -17. (It was also reported that on 18-DEC-2012 at 18:30 the ZOSTAVAX lot # H016765 was exposed to -14 for an estimated total time out of range of 12.57 hours). Last temperature recorded -16. On 10-DEC-2012, the patient was vaccinated with an out of temperature range dose of ZOSTAVAX (dose and route of administration were not provided) (lot # H016765) (dose number was not provided). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of an unknown age and gender. On 14-DEC-2012 at 07:45, ZOSTAVAX lot # H016765 was exposed to -14 or an estimated total time out of range of 13.25 hours. Last temperature recorder -17. (It was also reported that on 18-DEC-2012 at 18:30 the ZOSTAVAX lot # H016765 was exposed to -14 for an estimated total time out of range of 12.75 hours). last temperature recorded -16. On 11-DEC-2012, the patient was vaccinated with ab out of temperature range dose of ZOSTAVAX (dose and route administration were not provided) (lot # H016765) (dose number was not provided). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of an unknown age and gender. On 14-DEC-2012 at 07:45, ZOSTAVAX lot # H016765 was exposed to -14 for an estimated total time out of range of 13.25 hours. Last temperature recorded -17. (It was also reported that on 18-DEC-2012 at 18:30 the ZOSTAVAX lot # H016765 was exposed to -14 for an estimated total time out of range of 12.75 hours). Last temperature recorded -16. On 12-DEC-2012, the patient was vaccinated with an out of temperature range dose of ZOSTAVAX (dose and route administration were not provided) (lot # H016765) (dose number was not provided). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of unknown age and gender. On 14-DEC-2012 at 07:45, ZOSTAVAX lot # H016765 was exposed to -14 for an estimated total time out of range of 13.25 hours. Last temperature recorded -17. (It was also reported that on 18-DEC-2012 at 18:30 the ZOSTAVAX lot # H016765 was exposed to -14 for an estimated total time out of range of 12.57 hours). Last temperature recorded -16. On 12-DEC-2012, the patient was vaccinated with an out of temperature range dose of ZOSTAVAX (dose and route administration were not provided) (lot # H016765) (dose number was not provided). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of unknown age and gender. On 14-DEC-2012 at 07:45, ZOSTAVAX lot # H016765 was exposed to -14 for an estimated total time out of range of 13.25 hours. Last temperature recorded -17. (It was also reported that on 18-DEC-2012 at 18:30 the ZOSTAVAX lot # H016765 was exposed to -14 for an estimated total time out of range of 12.75 hours). Last temperature recorded -16. On 13-DEC-2012, the patient was vaccinated with an out of temperature range dose of ZOSTAVAX (dose and route administration were not provided) (lot # H016765) (dose number was not provided). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of an unknown age and gender. On 14-DEC-2012 at 07:45, ZOSTAVAX lot # H016765 was exposed to -14 for an estimated total time out of range of 13.25 hours. Last temperature recorded -17. (It was also reported that on 18-DEC-2012 at 18:30 the ZOSTAVAX lot # H016765 was exposed to -14 for an estimated total time out of range of 12.75 hours). Last temperature recorded -16. On 14-DEC-2012, the patient was vaccinated with an out of temperature range dose of ZOSTAVAX (dose and route administration were not provided) (lot # H016765) (dose number was not provided). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of an unknown age and gender. On 14-DEC-2012 at 07:45, ZOSTAVAX lot # H016765 was exposed to -14 for an estimated total time out of range of 13.25 hours. Last temperature recorded -17. (It was also reported that on 18-DEC-2012 at 18:30 the ZOSTAVAX lot # H016765 was exposed to -14 for an estimated total time out of range of 12.75 hours). Last temperature recorded -16. On 17-DEC-2012, the patient was vaccinated with an out of temperature range dose of ZOSTAVAX (dose and route administration were not provided) (lot # H016765) (dose number was not provided). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site swelling
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 a dose of ZOSTAVAX (lot#, expiration date, dose, route, indication not reported). On an unknown date the patient experienced a "bump" at the injection site after receiving ZOSTAVAX. The outcome of the event was unknown. This is one of several cases from same source. Additional information is not expected.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to an unspecified number of patients. On an unknown date the patients might have been vaccinated with PEDVAXHIB (lot #, expiration date, route and route unspecified) that was exposed to temperature conditions that Merck cannot support. NO PQC. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 28.0
Sex: M
Vaccine: MMR
Symptoms: Measles antibody negative
Clinical narrative: This spontaneous report as received from an approximately 28 year old male pathologists' assistant refers to himself. On unspecified date, the patient was vaccinated with two doses of M-M-R II (lot#, expire date, route, dose, strength and indication not reported) as a child. When two antibody titers were recently drawn the patient had low titer results for the measles, portion. On 13-JAN-2014 (today), the patient was vaccinated with one dose of M-M-R II injection (lot#, expire date, route, dose, strength and indication not reported) in the left arm. No adverse effects reported. It was unspecified if the patient seek medical attention. Additional information is not expected.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This spontaneous report as received from a consumer who is 53 year old male patient with prevention of shingles concerning himself. Patient had no pertinent medical history and drug allergies. On 19-JUL-2012 the patient was vaccinated with ZOSTAVAX (strength, dose, dose number, lot number and expiry date unknown). No concomitant medications were reported. In August 2012, the patient experienced rash on his back, feet and arms which comes and goes every other month. Patient sought medical attention and received HIBICLENS as treatment for the event. No laboratory tests were performed. The outcome of rash on his back, feet and arms was unknown. Additional information has been requested.
Age: 27.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Fall, Laceration, Syncope
Clinical narrative: Case number PHHY2013US069559 is an initial spontaneous report received from vaccine adverse event reporting system (VAERS reference number: 479433) web site on 03 Jul 2013, with a follow up received from the QA department (QA reference number: 239644) on 15 Jan 2014. This report refers to a 27-year-old male patient. His medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: 1207201) intramuscularly in left arm on 14 Dec 2012. On the same day approximately ten minutes after vaccination, he became lightheaded and fainted. He fell on to the floor, bumping his chin on way down resulting in laceration. Emergency medical service came, but patient refused to go to emergency room. The outcome of the events was reported as complete recovery. The seriousness and causality were reported. Based on the batch review, it was concluded that the concerned FLUVIRIN batch number 1207201 was manufactured in accordance with approved internal procedures and it is in compliance with the current good manufacturing practices (cGMP) requirements. Follow up received from the QA department (QA reference number: 239644) on 15 Jan 2014: Updated batch report.
Age: 18.0
Sex: M
Vaccine: FLU3, HPV4, MNQ
Symptoms: Dizziness, Dyskinesia, Fall, Gaze palsy, Muscle rigidity
Clinical narrative: Case number PHHY2013US069481 is an initial spontaneous report received from Vaccine Adverse Event Reporting System website (VAERS reference number: 479971) on 03 Jul 2013 and a follow-up information was received from Quality Assurance Department (reference number: 239781) on 09 Jul 2013 and another follow up was received from QA department on 20 Jan 2014. This report refers to an 18-year-old male patient. His medical history and concomitant medications were not reported. He was vaccinated with MENVEO (batch number: A10047, expiry date: Dec 2013) intramuscularly in to the left arm along with FLUARIX (other manufacturer, batch number: AFLUA702AA) intramuscularly in to the right arm and with GARDASIL (other manufacturer, batch number: H011350) intramuscularly in to the left arm on 21 Dec 2012. On the same day after vaccination, he stated he felt dizzy and fell backward in the chair. His eyes rolled back into lids and body became stiff and rigid. Then jerking rhythmical movements started. Outcome of the events was reported as completely recovered on an unspecified date. No additional information about seriousness and causality were reported. Batch review report (reference number: 239781) received from quality assurance department on 20 Jan 2014. Based on the batch review performed, it was concluded that MENVEO (batch number: A10047) was manufactured in accordance with approved internal procedures and it is in compliance with the current good manufacturing practices (cGMP) requirements. Non-significant follow-up received from Quality Assurance Department (reference number: 239781) on 09 Jul 2013: Updated QA reference number only. Significant follow up received from Quality Assurance Department on 20 Jan 2014: Updated Batch review report.
Age: 18.0
Sex: M
Vaccine: FLU3, HPV4, MNQ
Symptoms: Musculoskeletal stiffness
Clinical narrative: Case number PHHY2013US069481 is an initial spontaneous report received from Vaccine Adverse Event Reporting System website (VAERS reference number: 479971) on 03 Jul 2013 and a follow-up information was received from Quality Assurance Department (reference number: 239781) on 09 Jul 2013 and another follow up was received from QA department on 20 Jan 2014. This report refers to an 18-year-old male patient. His medical history and concomitant medications were not reported. He was vaccinated with MENVEO (batch number: A10047, expiry date: Dec 2013) intramuscularly in to the left arm along with FLUARIX (other manufacturer, batch number: AFLUA702AA) intramuscularly in to the right arm and with GARDASIL (other manufacturer, batch number: H011350) intramuscularly in to the left arm on 21 Dec 2012. On the same day after vaccination, he stated he felt dizzy and fell backward in the chair. His eyes rolled back into lids and body became stiff and rigid. Then jerking rhythmical movements started. Outcome of the events was reported as completely recovered on an unspecified date. No additional information about seriousness and causality were reported. Batch review report (reference number: 239781) received from quality assurance department on 20 Jan 2014. Based on the batch review performed, it was concluded that MENVEO (batch number: A10047) was manufactured in accordance with approved internal procedures and it is in compliance with the current good manufacturing practices (cGMP) requirements. Non-significant follow-up received from Quality Assurance Department (reference number: 239781) on 09 Jul 2013: Updated QA reference number only. Significant follow up received from Quality Assurance Department on 20 Jan 2014: Updated Batch review report.
Age: 17.0
Sex: M
Vaccine: FLU3
Symptoms: Disorientation, Loss of consciousness, Pallor
Clinical narrative: Case number PHHY2013US032423 is an initial spontaneous report received from vaccine adverse event reporting system (VAERS reference number: 481204) web site on 04 Apr 2013 with a follow up received from the quality assurance department (QA reference number: 221509) on 16 Jan 2014. This report refers to a 17-year-old male patient. He did not have any pre-existing conditions or allergies or known illness. His concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: 1207021, expiry date: Jun 2013) intramuscularly on to left arm on 11 Jan 2013. On the same day, after vaccination (unspecified duration), he passed out. He looked very pale and disoriented. He passed out for a second time during evaluation by the pharmacist. Emergency medical team was called and evaluated the patient. His mother requested no further service from the pharmacy or EMT and walked out of the pharmacy with the patient. The outcome of the event was reported as complete recovery. Based on the batch review performed, it was concluded the FLUVIRIN (batch number: 1207021) was manufactured in accordance with the approved internal procedures and in compliance with the cGMP requirements. Follow up received from the quality assurance department (QA reference number: 221509) on 16 Jan 2014: batch review was updated.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Serum sickness
Clinical narrative: Case number PHHY2013US056701, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 488644) website on 05 Jun 2013, with a follow up received from the Quality Assurance department (reference number: 233484) on 20 Jan 2014. This report refers to an 11-year-old male patient. His medical history and concomitant medication  were not reported. He was vaccinated with MENVEO (batch number: A11072, Expiry date: Jun 2014), GARDASIL (other manufacturer, batch number: H016238) and BOOSTRIX (other manufacturer, batch number: AC52B088AA) on 26 Feb 2013. On 28 Feb 2013, she developed serum reaction to vaccination. The event outcome was reported as condition unchanged as of 02 Mar 2013. The seriousness and causality of the event was not reported. Based on the batch review, it was stated that the concerned MENVEO batch number A11072 was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Follow up received from the QA department (reference number: 233484) on 20 Jan 2014: Updated batch report.
Age: 43.0
Sex: F
Vaccine: MNQ, PPV, TDAP, VARCEL
Symptoms: Injection site cellulitis
Clinical narrative: Case number PHHY2013US127701 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 498013) website on 11 Nov 2013 with a follow up information received from quality assurance department (reference number: 263745) on 21 Jan 2014. This report refers to a 43 year old female patient. Her medical history included allergic to iodides and her concomitant medication included propranolol 10 mg and Hydroxyzine pamoate 50 mg. She was vaccinated with MENVEO (batch number: A11033, expiry date: Jan 2014) intramuscularly on 24 Jul 2013. On the same day, she also received PNEUMOVAX (other manufacturer, batch number: H015749) intramuscularly, BOOSTRIX (other manufacturer, batch number: AC52B100BA) intramuscularly and VARIVAX (other manufacturer, batch number: H007451) subcutaneously. On 26 Jul 2013, she apparently developed cellulitis at the injection site. She visited the emergency room and was treated with antibiotics. Outcome of the event was reported as not recovered as of 29 Jul 2013. It was reported cellulitis at injection site occurred after VARIVAX administration and there was no other reaction with other vaccines. Based on the batch review performed it was concluded that the concerned MENVEO batch A11033 was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirement. Follow up information received from QA department on 21 Jan 2014: Updated batch review report.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Back pain, Central venous catheterisation, Gastrointestinal hypomotility, Hypokinesia, Paralysis
Clinical narrative: Case number PHHY2013US127691, is an initial report received from a consumer via Vaccine Adverse Event Reporting System (VAERS reference number: 502758) website on 11 Nov 2013 with a follow up received from the quality assurance department (QA reference number: 263362) on 16 Jan 2014. This report refers to 68-years-old male patient. His current illness included cervical spine arthritis and concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: 1207021, expiry date: 30 Jun 2013) on 10 Jan 2013. On 24 Jan 2013, he felt sharp pain in the back, started losing movement of legs and intestines. He was paralyzed from thorax down. Treatment consisted of plasma replacement and RITUXAN infused thru port inserted in chest. He was visited to the emergency room. The outcome of the events was reported as condition unchanged as of 16 Sep 2013. The seriousness of the case was reported as life threatening. The causality of the events was not reported. The batch review stated that based on the review performed, FLUVIRIN (batch number: 1207021) was manufactured in accordance with the approved internal procedures and in compliance with the cGMP requirements. Follow up received from the quality assurance department on 16 Jan 2014: The batch review was updated.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Plasmapheresis
Clinical narrative: Case number PHHY2013US127691, is an initial report received from a consumer via Vaccine Adverse Event Reporting System (VAERS reference number: 502758) website on 11 Nov 2013 with a follow up received from the quality assurance department (QA reference number: 263362) on 16 Jan 2014. This report refers to 68-years-old male patient. His current illness included cervical spine arthritis and concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: 1207021, expiry date: 30 Jun 2013) on 10 Jan 2013. On 24 Jan 2013, he felt sharp pain in the back, started losing movement of legs and intestines. He was paralyzed from thorax down. Treatment consisted of plasma replacement and RITUXAN infused thru port inserted in chest. He was visited to the emergency room. The outcome of the events was reported as condition unchanged as of 16 Sep 2013. The seriousness of the case was reported as life threatening. The causality of the events was not reported. The batch review stated that based on the review performed, FLUVIRIN (batch number: 1207021) was manufactured in accordance with the approved internal procedures and in compliance with the cGMP requirements. Follow up received from the quality assurance department on 16 Jan 2014: The batch review was updated.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Blood pressure, Blood pressure increased, Dizziness
Clinical narrative: Case number PHHY2013US139970 is an initial spontaneous report from a Vaccine Adverse Event Reporting System (reference number: 505411) received on 03 Dec 2013 and a follow-up received from Quality Assurance Department (QA, reference number: 269934) on 20 Jan 2014. This report refers to a 59-year-old female patient. Her concurrent conditions included faint and allergies to gentamycin, tetracycline and unknown medications. Concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 1309301) intramuscularly in the left arm on 02 Oct 2013. On the same day, 30 minutes after vaccination she felt faint and lowered herself to knees. The pharmacist measured blood pressure: 140/53 left arm and automatic cuff pulse: 73. She had a visit to emergency room due to this event. The patient recovered on the same day. Seriousness and causality of the event were not reported. Based on the batch review performed, the QA department concluded that the FLUVIRIN (batch number: 1309301) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Follow-up received from Quality Assurance Department (QA, reference number: 269934) on 20 Jan 2014: Updated batch review report.
Age: 17.0
Sex: F
Vaccine: FLU3, MNQ
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Case number PHHY2013US140156, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 506429) website on 03 Dec 2013 and a follow-up information was received from Quality Assurance department (reference number: 268933) on 09 Dec 2013 and another follow up was received from QA department on 17 Jan 2014. This report refers to a 17-year-old female patient. Her medical history included allergic rhinitis and eczema. She was vaccinated with MENVEO (batch number: A12127, expiry date: Aug 2014) in the right arm and FLUARIX (batch number: L4CP9, other manufacturer) in the left arm, both intramuscularly on 03 Oct 2013. On 05 Oct 2013, she experienced a large area of redness, pain and swelling at right upper arm involving half of her upper outer arm. She had no fever. The reaction was later diagnosed as cellulitis in the emergency room. Her body temperature reported as 98.1 (oral). She was treated with KEFLEX. The outcome of the events reported as recovered. The seriousness and causality of the events were not reported. Batch review report (reference number: 268933) received from quality assurance department on 17 Jan 2014. Based on the batch review performed, it was concluded that MENVEO (batch number: A12127, expiry date: Aug 2014) was manufactured in accordance with approved internal procedures and it is in compliance with the current good manufacturing practices (cGMP) requirements. Non-significant follow-up received from Quality Assurance Department (reference number: 268933) on 09 Dec 2013: Updated QA reference number only. Follow up received from Quality Assurance department on 17 Jan 2014: Updated Batch review report.
Age: 69.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Amnesia, Apparent life threatening event, Atrial flutter, Cardiac arrest, Cardiac stress test
Clinical narrative: Case number PHHY2013US146917 is an initial spontaneous report received from a consumer via Vaccine Adverse Event Reporting System (VAERS reference number: 507493) website on 16 Dec 2013, with the follow-up received on 20 Jan 2014. This report refers to a 69-year-old male patient. His medical history included bypass surgery in 1990 and 2003, carotid artery cleaned left side in 2010. He was nonsmoker and had no alcohol use and had no allergies. He was having a good physical health condition and had no indications that there was an imminent heart problem. He was vaccinated with seasonal influenza vaccine (manufacturer and batch number unknown) and pneumococcal vaccine (manufacturer and batch number unknown) at the same time on 20 Oct 2012. On the same day, shortly after vaccination, he had cardiac arrest and was revived by cardiopulmonary resuscitation (CPR). He was in hospital for 10 days and an implantable cardioverter-defibrillator (ICD) had been planted. He underwent nuclear stress test (results not provided) which showed minimal changes as compared with the one done in 2008. His cardioversion medication was changed. He had an atrial flutter that was not subsided. Since the event, he had memory loss. Outcome of cardiac arrest was recovered and outcome of the other events was reported as not recovered as of 28 Dec 2012. Reporter assessed the case as serious (life threatening and disability). No causality was reported for the events. Upon the follow-up, it was reported that patient was vaccinated FLUZONE (other manufacture, batch number: U4499AA) and not with the Novartis vaccine. Hence this case would be deactivated. Follow-up received from the Vaccine Adverse Event Reporting System (VAERS reference number: 507493) website on 20 Jan 2014: Upon the follow-up, it was reported that patient was vaccinated FLUZONE (other manufacture, batch number: U4499AA) and not with the Novartis vaccine. Hence this case would be deactivated.
Age: 69.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Disability, Implantable defibrillator insertion, Resuscitation
Clinical narrative: Case number PHHY2013US146917 is an initial spontaneous report received from a consumer via Vaccine Adverse Event Reporting System (VAERS reference number: 507493) website on 16 Dec 2013, with the follow-up received on 20 Jan 2014. This report refers to a 69-year-old male patient. His medical history included bypass surgery in 1990 and 2003, carotid artery cleaned left side in 2010. He was nonsmoker and had no alcohol use and had no allergies. He was having a good physical health condition and had no indications that there was an imminent heart problem. He was vaccinated with seasonal influenza vaccine (manufacturer and batch number unknown) and pneumococcal vaccine (manufacturer and batch number unknown) at the same time on 20 Oct 2012. On the same day, shortly after vaccination, he had cardiac arrest and was revived by cardiopulmonary resuscitation (CPR). He was in hospital for 10 days and an implantable cardioverter-defibrillator (ICD) had been planted. He underwent nuclear stress test (results not provided) which showed minimal changes as compared with the one done in 2008. His cardioversion medication was changed. He had an atrial flutter that was not subsided. Since the event, he had memory loss. Outcome of cardiac arrest was recovered and outcome of the other events was reported as not recovered as of 28 Dec 2012. Reporter assessed the case as serious (life threatening and disability). No causality was reported for the events. Upon the follow-up, it was reported that patient was vaccinated FLUZONE (other manufacture, batch number: U4499AA) and not with the Novartis vaccine. Hence this case would be deactivated. Follow-up received from the Vaccine Adverse Event Reporting System (VAERS reference number: 507493) website on 20 Jan 2014: Upon the follow-up, it was reported that patient was vaccinated FLUZONE (other manufacture, batch number: U4499AA) and not with the Novartis vaccine. Hence this case would be deactivated.
Age: 77.0
Sex: M
Vaccine: FLU3
Symptoms: Biopsy muscle abnormal, Biopsy peripheral nerve abnormal, Diplegia, Dysphagia, Dyspnoea
Clinical narrative: Case number PHHY2013US148728 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 512116) website on 16 Dec 2013 and a follow-up information was received from Quality Assurance department (reference number: 271503) on 20 Dec 2013 and another follow up was received from QA department on 16 Jan 2014. This report refers to a 77-year-old male patient. His medical history included diabetes, pacemaker and neuropathy. His concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: 1308201, expiry date: 31 Mar 2014) intramuscularly in to the left arm on 01 Oct 2013. On 08 Oct 2013, he experienced leg weakness that resulted in a fall. Weakness and paralysis moved to arms. His speech, swallowing and breathing were all affected adversely. Laboratory test included connective nerve study and muscle and nerve biopsy and he was diagnosed with Guillain-Barre Syndrome on an undetermined date. Plasmapheresis treatments (five, every other day) were given that yielded positive response. Patient was in rehabilitation at a 24/7 care facility at the time of reporting. Outcome of the events was reported as condition unchanged as on 08 Nov 2013. The reporter assessed the events as life threatening. No further information about causality was provided. Batch review report (reference number: 271503) received from quality assurance department on 20 Jan 2014. Based on the batch review performed, it was concluded that FLUVIRIN (batch number: 1308201) was manufactured in accordance with approved internal procedures and it is in compliance with the current good manufacturing practices (cGMP) requirements. Non-significant follow-up received from Quality Assurance Department (reference number: 271503) on 20 Dec 2013: Updated QA reference number only. Follow up received from Quality Assurance department on 16 Jan 2014: Updated Batch review report.