chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 14.0
Sex: F
Vaccine: HEPA, TDAP, VARCEL
Symptoms: Asthenia, Dizziness, Full blood count normal, Injection site erythema, Malaise
Clinical narrative: Swelling and redness and pain and tenderness at vaccine site right arm followed by fever, myalgia, malaise, URI symptoms and increased swelling and pian, weakness, dizziness bringing her to the ER.
Age: 14.0
Sex: F
Vaccine: HEPA, TDAP, VARCEL
Symptoms: Metabolic function test normal, Myalgia, Pyrexia, Upper respiratory tract infection, Vaccination site pain
Clinical narrative: Swelling and redness and pain and tenderness at vaccine site right arm followed by fever, myalgia, malaise, URI symptoms and increased swelling and pian, weakness, dizziness bringing her to the ER.
Age: 14.0
Sex: F
Vaccine: HEPA, TDAP, VARCEL
Symptoms: Vaccination site swelling
Clinical narrative: Swelling and redness and pain and tenderness at vaccine site right arm followed by fever, myalgia, malaise, URI symptoms and increased swelling and pian, weakness, dizziness bringing her to the ER.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Local reaction
Clinical narrative: Local reaction redness, swelling, heat at injection site of 11cm. Patients left arm circumference is 3cm larger than the right arm and the patient is right handed. 12% increase from sIte swelling.
Age: 0.01
Sex: F
Vaccine: HEP
Symptoms: Cyanosis, Sleep apnoea syndrome
Clinical narrative: This spontaneous report as received from a consumer refers to a 4 day old premature baby girl. On 05-MAR-2014 the patient was vaccinated with an unspecified Hepatitis B vaccine (manufacturer unknown) (route, dose number, dosage and lot number unknown). After receiving the vaccine the newborn baby experienced two short episodes of sleep apnea where her lips turned blue, but the nurse brought her back around both times and the baby stayed in the hospital for a couple extra days before discharging. Medical attention was sought for the baby while in the hospital. The outcome of the events was reported as recovered. Additional information has been requested.
Age: 41.0
Sex: U
Vaccine: TDAP
Symptoms: Erythema, Feeling hot, Local swelling, Pain in extremity
Clinical narrative: 3/11/14 - Lt arm pain, red, swollen, hot after receiving TDAP 2/28/14.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Pt. seen 3/11/14 for 5 yr WCE. Per mom's request, both required imm. were given in (Rt) arm (pt. is lt-handed). Developed s/s: (Rt) arm with erythema 3 x 5.5 cm to upper arm with mild warmth; non-tender. TX with ibuprofen and ice packs PRN.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Blood test, Pyrexia
Clinical narrative: Vaccination given 2/28/14, developed fever next day. Temp up to 105 degrees. Went to emergency room 3/9/14.
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Condition aggravated, Injection site erythema, Injection site pruritus, Migraine
Clinical narrative: Pt states she first noticed redness, itching 2 days ago, on her right upper arm where she had PREVNAR shot on 3/4/14. The area is itchy. No fever, chills, or sweats. She has had increased migraines 1/day since having the PREVNAR vaccine.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU3, MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Pyrexia
Clinical narrative: Injection site - indurated, swollen, erythematous. Fever.
Age: 1.01
Sex: M
Vaccine: MMR, MMRV, VARCEL
Symptoms: Incorrect drug dosage form administered, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to a 12 month old male patient. On 11-MAR-2014, the patient was vaccinated with M-M-R II 0.5 ml subcutaneously. On the same day, the patient was vaccinated with VARIVAX (merck), .5 ml, subcutaneous. The VARIVAX (merck) was inadvertently reconstituted with PROQUAD (merck) 0.5 ml (route was not reported). No adverse effect was reported. No further information was provided. Additional information has been requested.
Age: 62.0
Sex: M
Vaccine: TDAP
Symptoms: Dyspnoea, Headache, Muscle fatigue
Clinical narrative: Shortness of breath, headache, muscle fatigue/headache.
Age: 57.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain, Injection site reaction, Lymphadenopathy, Neuralgia
Clinical narrative: The day following vaccine, pt started to have nerve pain from the site of admin to left hand, then radiate to right clavicle. On 3/9/14 (2 days after) he started to experience nerve pain in the mouth and swollen lymph node behind left ear. He took TYLENOL and will get x-ray from his dentist.
Age: 15.0
Sex: F
Vaccine: FLU3, HEPA, MNQ
Symptoms: Dizziness, Heart rate decreased, Hyperhidrosis, Pallor, Vomiting
Clinical narrative: After the 3 IM shots, she became pale/stood-up and feeling faint and dizzy. Pale, HR decreased 50, sweaty, vomited. After while rested on a chair, laid on the exam table gradually improved - pinked-up HR above 80 strong. Exam NL after 20-40 min observation.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Burning sensation, Throat tightness
Clinical narrative: Approximately 30 minutes after vaccine administration patient began to experience constriction in throat and burning sensation in palms. Patient went to ER and was given 3 days of prednisone and famotidine.
Age: 0.2
Sex: M
Vaccine: RV5
Symptoms: Erythema, Immediate post-injection reaction, Urticaria
Clinical narrative: Developed 2 separate 1.5 cmn red hives on elbow/forearm area immediately after giving ROTATEQ vaccine. No difficulty breathing.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Insomnia, Myalgia
Clinical narrative: Pain rt shoulder, moderate feels pain increasing. Cannot sleep at night. Myalgia after flu shot vaccine. Pain level 8/10. Pain level decreased to 4 at discharge.
Age: 0.77
Sex: F
Vaccine: FLU3, HIBV
Symptoms: Crying, Irritability, Pyrexia, Rhinorrhoea
Clinical narrative: Fever of 102.7, fussiness, runny nose, crying.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Stevens-Johnson syndrome
Clinical narrative: Mild case of (SJS) Stevens-Johnson syndrome. Vacc administered 2-28-14. Signs and sx appeared 3-3-14. TX: nystatin (oral) prior to vacc administ, hydroxyzine, MEDROL, ZANTAC, triamcinolone oint.
Age: 29.0
Sex: F
Vaccine: FLU3, HEP, TDAP
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: Patient described excessive pain at injection sites and in the left arm in general (that is, the whole arm).
Age: 45.0
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse (also reported as registered nurse), refers to a 45 year old patient of unknown gender. No pertinent medical history or drug reactions/allergies were provided. On 08-OCT-2013, the patient was vaccinated with MMR II (lot number H016132; expiry date 31-AUG-2014; dose and route not provided). No co-suspect or concomitant therapies were reported. It was reported that the MMR II vaccine administered to the patient was exposed to temperatures above 8 degrees C (between 8.09 and approximately 22.36 degrees C), since 05-OCT-2013. No adverse effect had been reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 57.0
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse (also reported as registered nurse), refers to a 57 year old patient of unknown gender. No pertinent medical history or drug reactions/allergies were provided. On 07-OCT-2013, the patient was vaccinated with M-M-R II (Lot number H016132; expiry date 31-AUG-2014; dose and route not provided). No co-suspect or concomitant therapies were reported. It was reported that the M-M-R II administered to the patient was exposed to temperatures above 8 degrees C (approximately between 8.09 and 9.55 degrees C), since 05-OCT-2013. No adverse effect had been reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 32.0
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse (also reported as registered nurse), refers to a 32 year old patient of unknown gender. No pertinent medical history or drug reactions/allergies were provided. On 23-OCT-2013, the patient was vaccinated with M-M-R II (Lot number reported as J008882; expiry date, does and route not provided). No co-suspect or concomitant therapies were reported. It was reported that the M-M-R II administered to the patient was exposed to temperatures above 8 degrees C (between 8.09 and 22.73 degrees C) during 42.78 hours, from 05-OCT-2013 until 09-OCT-2013. No adverse effect had been reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Herpes zoster, Rash
Clinical narrative: "Breakout" on 3/8/14 -> went to doctor -> Dx "shingles" all over body. "Feeling bad" on 3/7/14. Date ZOSTAVAX administered on 3/4/14.
Age: 40.0
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse (also reported as registered nurse), refers to a 40 year old patient of unknown gender. No pertinent medical history or drug reactions/allergies were provided. On 24-OCT-2013, the patient was vaccinated with MMR II (Lot number J003625; expiry date 22-MAR-2015; dose and route not provided). No co-suspect or concomitant therapies were reported. It was reported that the MMR II administered to the patient was exposed to temperatures above 8 degrees C (between 8.09 and 22.73 degrees C) during 42.78 hours, from 05-OCT-2013 until 09-OCT-2013. No adverse effect had been reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 31.0
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse (also reported as registered nurse), refers to a 41 year old patient of unknown gender. No pertinent medical history or drug reactions/allergies were provided. On 04-NOV-2013, the patient was vaccinated with MMR II (Lot number J003625; expiry date 22-MAR-2015; dose and route not provided). No co-suspect or concomitant therapies were reported. It was reported that the MMR II administered to the patient was exposed to temperatures above 8 degrees C (between 8.09 and 22.73 degrees C) during 42.78 hours, from 05-OCT-2013 until 09-OCT-2013. No adverse effect had been reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse (also reported as registered nurse), refers to patient of unknown age and gender. No pertinent medical history or drug reactions/allergies were provided. On 18-NOV-2013, the patient was vaccinated with M-M-R II (Lot number J003625; expiry date 22-MAR-2015; dose and route not provided). No co-suspect or concomitant therapies were reported. It was reported that the M-M-R II administered to the patient that was exposed to temperatures above 8 degrees C (between 8.09 and 22.73 degrees C) during 42.78 hours, from 05-OCT-2013 until 09-OCT-2013. No adverse effect had been reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 27.0
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse (also reported as registered nurse), refers to a 27 year old patient of unknown gender. No pertinent medical history or drug reactions/allergies were provided. On 15-NOV-2013, the patient was vaccinated with MMR II (Lot number J003625; expiry date 22-MAR-2015; dose and route not provided). No co-suspect or concomitant therapies were reported. It was reported that the MMR II administered to the patient was exposed to temperatures above 8 degrees C (between 8.09 and 22.73 degrees C) during 42.78 hours, from 05-OCT-2013 until 09-OCT-2013. No adverse effect had been reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse (also reported as registered nurse), refers to a patient of unknown age and gender. No pertinent medical history or drug reactions/allergies were provided. On 19-NOV-2013, the patient was vaccinated with M-M-R II (lot number J003625; expiry date 22-MAR-2015; dose and route not provided). No co-suspect or concomitant therapies were reported. It was reported tha the M-M-R administered to the patient was exposed to temperatures above 8 degrees C (between 8.09 and 22.73 degrees C) during 42.78 hours, from 05-OCT-2013 until 09-OCT-2013. No adverse effect had been reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 32.0
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse (also reported as registered nurse), refers to a 32 year old patient of unknown gender. No pertinent medical history or drug reactions/allergies were provided. On 02-DEC-2013, the patient was vaccinated with MMR II (Lot number J008882; expiry date, dose and route not provided). No co-suspect or concomitant therapies were reported. It was reported that the MMR II administered to the patient was exposed to temperatures above 8 degrees C (between 8.09 and 22.73 degrees C) during 42.78 hours, from 05-OCT-2013 until 09-OCT-2013. No adverse effect had been reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 21.0
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse (also reported as registered nurse), refers to a 21 year old patient of unknown gender. No pertinent medical history of drug reactions/allergies were provided. On 12-DEC-2013, the patient was vaccinated with M-M-R II (Lot number J003625; expiry date 22-MAR-2015; dose and route not provided. No co-suspect or concomitant therapies were reported. It was reported that the M-M-R II administered to the patient was exposed to temperatures above 8 degrees C (between 8.09 and 22.73 degrees C) during 42.78 hours, form 05-OCT-2013 until 09-OCT-2013. No adverse effect had been reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 21.0
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse (also reported as registered nurse), refers to a 21 year old patient of unknown gender. No pertinent medical history or drug reactions/allergies were provided. On 19-FEB-2014 00:00, the patient was vaccinated with M-M-R II (Lot number reported as J008882; expiry date, dose and route not provided). No co-suspect or concomitant therapies were reported. It was reported that the M-M-R II administered to the patient was exposed to temperature above 8 degrees C (between 8.09 and 22.73 degrees C) during 42.78 hours, from 05-OCT-2013 until 09-OCT-2013. No adverse effect had been reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 28.0
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse (also reported as registered nurse), refers to a 28 year old patient of unknown gender. No pertinent medical history or drug reactions/allergies were provided. On 18-FEB-2014, the patient was vaccinated with MMR II (Lot number J008882; expiry date, dose and route not provided). No co-suspect or concomitant therapies were reported. It was reported that the MMR II administered to the patient was exposed to temperatures above 8 degrees C (between 8.09 and 22.73 degrees C) during 42.78 hours, from 05-OCT-2013 until 09-OCT-2013. No adverse effect had been reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 20.0
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous reports as received from a licensed practical nurse (also reported as registered nurse), refers to a 20 year old patient of unknown gender. No pertinent medical history or drug reactions/allergies were provided. On 27-FEB-2014, the patient was vaccinated with M-M-R II (Lot number reported as J008882; expiry date, dose and route not provided). No co-suspect or concomitant therapies were reported. It was reported that the M-M-II administered to the patient was exposed to temperatures above 8 degrees C (between 8.09 and 22.73 degrees C) during 42.78 hours, from 05-OCT-2013 until 09-OCT-2013. No adverse effect had been reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 67.0
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse (also reported as registered nurse), refers to a 67 year old patient of unknown gender. No pertinent medical history or drug reactions/allergies were provided. On 11-FEB-2014 (also reported as 11-FEB-2013), the patient was vaccinated with M-M-R II (Lot number reported as J008882; expiry date, dose and route not provided). No co-suspect or concomitant therapies were reported. It was reported that the M-M-R II administered to the patient was exposed to temperatures above 8 degrees C (between 8.09 and 22.73 degrees C) during 42.78 hours, from 05-OCT-2013 until 09-OCT-2013. No adverse effect had been reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Blepharospasm, Muscle spasms, Skin warm
Clinical narrative: This spontaneous report as received from a physician refers to a 21 year old female patient. The patient's medical history included thyroid history. On 01-MAR-2014 the patient was vaccinated with second dose of GARDASIL lot # H015863, expiration date 24-FEB-2015, 0.5 ml, intramuscular for family history of Cervical Cancer. There was no concomitant medication. On 04-MAR-2014 (Tuesday) the patient experienced body spasms. In March 2014 the patient's body was "hot to touch" and the patient also developed twitching in an unspecified eye in March 2014. The patient sought medical attention via informing the physician on an unspecified way. No lab diagnostics studies performed. There was no treatment given for the event. The outcome of the events was reported as not recovered. Additional information has been requested.
Sex: U
Vaccine: VARCEL, VARZOS
Symptoms: Wrong drug administered
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with VARIVAX (dose, strength, route and lot number were not provided). Other suspect therapies included ZOSTAVAX (dose, strength, route and lot number were not reported). Concomitant therapies were not reported. Pharmacist reported on behalf of his wife, who was also a pharmacist, that she inadvertently administered a dose of VARIVAX to a patient that was prescribed ZOSTAVAX (date unspecified). Additional information has been requested.
Age: 20.0
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse (also reported as registered nurse), refers to a 20 year old patient of unknown gender. No pertinent medical history or drug reactions/allergies were provided. On 22-OCT-2013, the patient was vaccinated with MMR II (Lot number J003625; expiry date 22-MAR-2015; dose and route not provided). No co-suspect or concomitant therapies were reported. It was reported that the MMR II administered to the patient was exposed to temperatures above 8 degrees C (between 8.09 and 22.73 degrees C) during 42.78 hours, from 05-OCT-2013 until 09-OCT-2013. No adverse effect had been reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 25.0
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse (also reported as registered nurse), refers to a 25 year old patient of unknown gender. No pertinent history or drug reaction/allergies were provided. On 09-OCT-2013, the patient was vaccinated with MMR II (lot number H016632; expiry date 31-AUG-2014; dose and route not provided). No co-suspect or concomitant therapies were reported. It was reported that the MMR II administered to the patient was exposed to temperatures above 8 degrees C (approximately between 8/09 and 22.73 degrees C) during approximately 42.78 hours, since 05-OCT-2013. No adverse effect has been reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 49.0
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse (also reported as registered nurse), refers to a 49 year old patient of unknown gender. No pertinent medical history or drug reactions/allergies were provided. On 17-FEB-2014, the patient was vaccinated with MMR II (Lot number reported as J008882; expiry date, dose and route not provided). No co-suspect or concomitant therapies were reported. It was reported that the MMR II administered to the patient was exposed to temperatures above 8 degrees C (between 8.09 and 22.73 degrees C) during 42.78 hours, from 05-OCT-2013 until 09-OCT-2013. No adverse effect had been reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 54.0
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse (also reported as registered nurse), refers to a 54 year old patient of unknown gender. No pertinent medical history or drug reactions/allergies were provided. On 12-FEB-2014, the patient was vaccinated with MMR II (Lot number reported as J008882; expiry date, dose and route not provided). No co-suspect or concomitant therapies were reported. It was reported that the MMR II administered to the patient was exposed to temperatures above 8 degrees C (between 8.09 and 22.73 degrees C) during 42.78 hours, from 05-OCT-2013 and 09-OCT-2013. No adverse effect had been reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: This spontaneous report was received from a physician via a company representative, concerning to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies were not provided. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX vial, (dose, route, lot number and expiration date were not provided). Co-suspect therapy and concomitant medications were not provided. On an unknown date, the patient had a zoster rash on the unspecified arm that was the same arm of vaccination with ZOSTAVAX. The patient sought unspecified medical attention. On an unknown date, the patient recovered from the event. The relatedness between the event and suspect therapy was not provided. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist concerning an infant patient of unknown age and gender. Medical history or concurrent conditions were not reported. On an unspecified date, the infant patient was vaccinated with a dose of GARDASIL. (Dose, frequency, lot number and strength not provided). Co-suspect or concomitant therapies were not reported. Pharmacist had no specific details regarding the patient or the administration. No adverse effect reported. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Feeding disorder neonatal
Clinical narrative: NB feeding problems on 2014-02-21.
Age: 66.0
Sex: F
Vaccine: TDAP
Symptoms: Adverse event
Clinical narrative: Adv eff pertussis vaccine on 2014-01-29.
Age: 0.15
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Ot serum react d/t vacc on 2014-02-28. Clinician comment: Diarrhea, vomiting after ROTATEQ vaccine.
Age: 55.0
Sex: M
Vaccine: HEPA
Symptoms: Hypersensitivity, Insomnia, Local swelling, Pruritus, Rash
Clinical narrative: This case was reported by a consumer (subject) and described the occurrence of allergic reaction in a 55-year-old male subject who was vaccinated with HAVRIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent medical conditions included exposure to hepatitis A and penicillin allergy. Concurrent medications included ADDERALL and Omeprazole. On 7 June 2013 at 17:30 the subject received a dose of HAVRIX (unknown details, left arm). On 8 June 2013, 1 day after vaccination with HAVRIX, the subject experienced allergic reaction, hive, itching. In June 2013, an unknown number of days after vaccination with HAVRIX, the subject experienced sunburn-like reaction. On 3 July 2013, 26 days after vaccination with HAVRIX, the subject experienced unable to sleep. On 9 July 2013, the subject experienced bump on thigh and discolored area on skin. On 8 June 2013, approximately 16:30 to 17:00, the subject experienced hives from waist to knees ("mostly covered his thighs") and was itching "like crazy." The subject's physician prescribed a steroid cream, ZANTAC, and BENADRYL. The itching and hives seemed to resolve around 18 June 2013. On 21 June 2013, the subject experienced hives from "left hip to right hip below belly button." The subject started using "the cream and taking ZANTAC, BENADRYL, and CLARITIN to treat the hives." On 30 June 2013, the subject reported that the hives were gone, but his "skin still looked like he had a light sunburn." On 3 July 2013, the subject was working in the yard and started getting itchy. "When he went to take a shower", the subject noticed "he was a solid hive from his waist to about 2 inches above his knees" and hives on his genitals. The subject took ZANTAC and applied "heavy amount of cream" but was "up all night" [unable to sleep]. During the night, the subject took 2 oatmeal baths: at 23:00 to midnight (3 July 2013) and at 2:00-3:00 (4 July 2013). On 9 July 2013, the subject reported that he was still "breaking out on left and right buttocks." He also reported his thighs have some bumps but are mostly just discolored. He also reported that he "still itches when the BENADRYL and ZANTAC wear off." The subject also reported that the hives were improving but would flare if he "went out and took a walk." The subject was treated with ZANTAC, BENADRYL, CLARITIN, Steroid cream and Oatmeal bath. At the time of reporting the outcome of the event of hive had improved. At the time of reporting, the outcome of the events of allergic reaction, itching, sunburn-like reaction, unable to sleep, bump on thigh, and discolored area on skin were unspecified. The subject reported another case with HAVRIX. See case A1034250A for details on that case.
Age: 55.0
Sex: M
Vaccine: HEPA
Symptoms: Skin discolouration, Sunburn, Urticaria
Clinical narrative: This case was reported by a consumer (subject) and described the occurrence of allergic reaction in a 55-year-old male subject who was vaccinated with HAVRIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent medical conditions included exposure to hepatitis A and penicillin allergy. Concurrent medications included ADDERALL and Omeprazole. On 7 June 2013 at 17:30 the subject received a dose of HAVRIX (unknown details, left arm). On 8 June 2013, 1 day after vaccination with HAVRIX, the subject experienced allergic reaction, hive, itching. In June 2013, an unknown number of days after vaccination with HAVRIX, the subject experienced sunburn-like reaction. On 3 July 2013, 26 days after vaccination with HAVRIX, the subject experienced unable to sleep. On 9 July 2013, the subject experienced bump on thigh and discolored area on skin. On 8 June 2013, approximately 16:30 to 17:00, the subject experienced hives from waist to knees ("mostly covered his thighs") and was itching "like crazy." The subject's physician prescribed a steroid cream, ZANTAC, and BENADRYL. The itching and hives seemed to resolve around 18 June 2013. On 21 June 2013, the subject experienced hives from "left hip to right hip below belly button." The subject started using "the cream and taking ZANTAC, BENADRYL, and CLARITIN to treat the hives." On 30 June 2013, the subject reported that the hives were gone, but his "skin still looked like he had a light sunburn." On 3 July 2013, the subject was working in the yard and started getting itchy. "When he went to take a shower", the subject noticed "he was a solid hive from his waist to about 2 inches above his knees" and hives on his genitals. The subject took ZANTAC and applied "heavy amount of cream" but was "up all night" [unable to sleep]. During the night, the subject took 2 oatmeal baths: at 23:00 to midnight (3 July 2013) and at 2:00-3:00 (4 July 2013). On 9 July 2013, the subject reported that he was still "breaking out on left and right buttocks." He also reported his thighs have some bumps but are mostly just discolored. He also reported that he "still itches when the BENADRYL and ZANTAC wear off." The subject also reported that the hives were improving but would flare if he "went out and took a walk." The subject was treated with ZANTAC, BENADRYL, CLARITIN, Steroid cream and Oatmeal bath. At the time of reporting the outcome of the event of hive had improved. At the time of reporting, the outcome of the events of allergic reaction, itching, sunburn-like reaction, unable to sleep, bump on thigh, and discolored area on skin were unspecified. The subject reported another case with HAVRIX. See case A1034250A for details on that case.
Age: 18.0
Sex: F
Vaccine: HPV4, TDAP, VARCEL
Symptoms: Blood folate normal, Blood glucose normal, Blood thyroid stimulating hormone normal, Depersonalisation, Depression
Clinical narrative: Patient was seen in our clinic on 3 visits she is diagnosed with: Generalized Anxiety Disorder, Depressive Disorder NOS. Her episodes of derealization/depersonalization are probably due to her anxiety, they have improved by 60% since pt is on PROZAC 20 mg/day. Patient needs to continue her treatment.
Age: 18.0
Sex: F
Vaccine: HPV4, TDAP, VARCEL
Symptoms: Derealisation, Electroencephalogram, Electroencephalogram normal, Generalised anxiety disorder, Nuclear magnetic resonance imaging brain normal
Clinical narrative: Patient was seen in our clinic on 3 visits she is diagnosed with: Generalized Anxiety Disorder, Depressive Disorder NOS. Her episodes of derealization/depersonalization are probably due to her anxiety, they have improved by 60% since pt is on PROZAC 20 mg/day. Patient needs to continue her treatment.
Age: 18.0
Sex: F
Vaccine: HPV4, TDAP, VARCEL
Symptoms: Thyroid function test normal, Vitamin B12 normal
Clinical narrative: Patient was seen in our clinic on 3 visits she is diagnosed with: Generalized Anxiety Disorder, Depressive Disorder NOS. Her episodes of derealization/depersonalization are probably due to her anxiety, they have improved by 60% since pt is on PROZAC 20 mg/day. Patient needs to continue her treatment.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Injection site erythema, Rash vesicular
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 61 year old female patient. On 17-FEB-2014, the patient was vaccinated with ZOSTAVAX lot # J008432 (Expiry: 11-OCT-2014), 0.65 ml, subcutaneous. Concomitant medications included blood pressure medication and estrogen replacement. On 18-FEB-2014, the patient developed viral symptoms. On 19-FEB-2014, the patient experienced shingles. The patient sought medical attention and saw her physician. The patient was treated with VALTREX. The outcome of the event shingles was reported as resolving. The reporter did not provide the causality between the event and the suspect drug. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Viral infection
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 61 year old female patient. On 17-FEB-2014, the patient was vaccinated with ZOSTAVAX lot # J008432 (Expiry: 11-OCT-2014), 0.65 ml, subcutaneous. Concomitant medications included blood pressure medication and estrogen replacement. On 18-FEB-2014, the patient developed viral symptoms. On 19-FEB-2014, the patient experienced shingles. The patient sought medical attention and saw her physician. The patient was treated with VALTREX. The outcome of the event shingles was reported as resolving. The reporter did not provide the causality between the event and the suspect drug. Additional information has been requested.
Age: 1.5
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Abnormal behaviour, Anxiety, Blood test normal, Crying, Drooling
Clinical narrative: 18 month old boy who developed increased agitation and irritability, after receiving varicella vaccine. Seen twice in hospital ER work-up unrevealing. Gradually improved the following day.
Age: 1.5
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Gait disturbance, Glassy eyes, Insomnia, Lumbar puncture normal, Movement disorder
Clinical narrative: 18 month old boy who developed increased agitation and irritability, after receiving varicella vaccine. Seen twice in hospital ER work-up unrevealing. Gradually improved the following day.
Age: 1.5
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Muscular weakness, Mydriasis, Respiration abnormal, Restlessness, Screaming
Clinical narrative: 18 month old boy who developed increased agitation and irritability, after receiving varicella vaccine. Seen twice in hospital ER work-up unrevealing. Gradually improved the following day.
Age: 1.5
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Speech disorder, Staring, Ultrasound scan normal, Urine analysis normal
Clinical narrative: 18 month old boy who developed increased agitation and irritability, after receiving varicella vaccine. Seen twice in hospital ER work-up unrevealing. Gradually improved the following day.
Age: 1.5
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Agitation, Irritability
Clinical narrative: 18 month old boy who developed increased agitation and irritability, after receiving varicella vaccine. Seen twice in hospital ER work-up unrevealing. Gradually improved the following day.
Age: 0.35
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Crying, Pyrexia
Clinical narrative: Fever (104.5).  Prolonged crying.  Difficult to console.
Age: 16.0
Sex: F
Vaccine: MEN
Symptoms: Amnesia, Fall, Syncope
Clinical narrative: Fainting, fell to floor (head injury?), temporary short term memory loss.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. Medical assistant reported that an unspecified number of patients might have received an unspecified number of doses of MMR II (lot #, dose, frequency, route and indication not reported) that were exposed to temperatures outside of the prescribing information which were not supported. No adverse events were reported. This follow-up was received from the certified medical assistant, who confirmed that MMR II was exposed to temperatures outside of range multiple times for a total time of 7 hours, with a highest temperature of 53F. She did not have any patient specific information. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Dyspnoea, Influenza like illness, Malaise, Pain
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a female patient of unknown age with no Pertinent Medical History and no Drug Reactions/Allergies. In approximately March 2010 (4 years ago) the patient was vaccinated with the first dose of GARDASIL, injection, (lot # expiration date and dose unspecified) for Immunisation in an unspecified physician's office, and reported "flu like symptoms" after receiving the dose. She reported body aches and malaise and shortness of breath. She reported that these symptoms resolved without treatment. She reports that the patient stated that she experienced the same symptoms after receiving the second dose of GARDASIL. The patient's symptoms resolved on their own after the second dose as well, in an unspecified amount of time. The patient had not yet received the third dose. The event outcome was reported as recovered. The patient sought medical attention. No treatment was given. Additional information has been requested.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician refers to a 79 year old male patient. No pertinent history was reported. On 04-MAY-2007, the patient was vaccinated with ZOSTAVAX Lot # 656395/0190U (Expiry: 02-AUG-2008) (dose, route and frequency were not reported). No concomitant medications were reported. On 18-FEB-2014, the patient experienced shingles. The patient sought medical attention and visited the office and was treated with unspecified antiviral medication. No lab diagnostics studies performed. The outcome of the event shingles was reported as recovering. The reporter did not provide the causality between the event and the suspect drug. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Pyrexia
Clinical narrative: This spontaneous report was received from a physician concerning 65 year old male patient with heart disease and drug reaction/allergy to LIPITOR. On 26-FEB-2014, patient started therapy with ZOSTAVAX, 19400 PFU, (Lot: J011830) to prevent shingles. (Dose and frequency not provided). Concomitant therapies reported as AMBIEN, aspirin, CRESTOR, LEXAPRO, isosorbide mononitrate, lisinopril (manufacturer unknown), NIFEDICAL, NORCO, PLAVIX and XANAX. On 28-FEB-2014, patient experienced chills and persistent fever since he received ZOSTAVAX. Patient sought medical attention through an office visit. Patient received treatment with TAMIFLU. Lab diagnostic test were not performed. At the time of the report, the outcome of the events was reported as not recovered. The causal relationship between ZOSTAVAX and the events was unknown. Additional information has been requested.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, Neuropathy peripheral
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 84 year old female patient. The patient pertinent medical history included high blood pressure, low thyroid and high cholesterol. On 11-MAR-2014, the patient was vaccinated with ZOSTAVAX Lot # J013138 (Expiry: 17-JAN-2015) 0.65 ml, subcutaneous. Concomitant medications included pravastatin sodium, lisinopril, ZETIA, sotalol, levothyroxine sodium, hydrochlorothiazide and amlodipine. On 11-MAR-2014, 40 minutes after the patient was vaccinated with ZOSTAVAX experienced the neuropathy in the feet was reactivated. The patient was sought medical attention. The pharmacist also reported that the patient received the ZOSTAVAX which was exposed to 42F for 81 hours. The outcome of the event neuropathy in the feet was reactivated was reported as not recovered. The reporter did not provide the causality between the event and the suspect drug. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Blood test, Exposure during pregnancy, No adverse event, Pregnancy test, Smear cervix
Clinical narrative: This spontaneous report was received from a Nurse refers to a 24 year old female patient. On 12-MAR-2014, the patient while pregnant was vaccinated with GARDASIL lot # J006850 (Expiry: 31-MAR-2016), 0.5 ml, intramuscular. Concomitant medications included sertraline hydrochloride and fluconazole. The patient was sought medical attention and was at physician office when she received the vaccine. The patient underwent unspecified pregnancy test, unspecified blood work and pap smear. It was reported that the patient last menstrual period was on an unknown date last month. No adverse effects reported. No further information provided. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 67 year old female patient. The patient had egg allergy. on 04-MAR-2014 the patient was vaccinated with PNEUMOVAX 23 lot # J013345 (Expiry: 11-JAN-2015) 0.5 ml, intramuscular. Concomitant medications included SYNTHROID, ZOLOFT, MELOXICAM, DIAZEPAM and METFORMIN. On 04-MAR-2014, the patient remained in the pharmacy for 15 minutes after receiving PNEUMOVAX 23 and had no issues. On 04-MAR-2014, the patient experienced fever after returned home. The outcome of the event was reported as recovering (also reported as she is fine). The reporter did not provide the causality between the event and the suspect drug. Additional information has been requested.
Age: 42.0
Sex: F
Vaccine: MMR
Symptoms: Erythema, Injection site erythema, Injection site rash, Measles antibody positive, Mumps antibody test positive
Clinical narrative: 7 hrs after receiving MMR in (R) arm, reports severe itching, redness and hives on chest. Took BENADRYL 50 mg po x CLARITIN 20 mg this am. Then in notes remain rash on chest and redness surrounding injection site.
Age: 42.0
Sex: F
Vaccine: MMR
Symptoms: Pruritus, Rash, Rubella antibody negative, Urticaria
Clinical narrative: 7 hrs after receiving MMR in (R) arm, reports severe itching, redness and hives on chest. Took BENADRYL 50 mg po x CLARITIN 20 mg this am. Then in notes remain rash on chest and redness surrounding injection site.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a consumer refers to herself as a female patient of unknown age. The patient reported that on 18-APR-2013, she received the first dose of GARDASIL (dose, route and frequency were not reported). On 01-JUL-2013, the patient was vaccinated with a second dose of GARDASIL (dose, route and frequency were not reported). The patient stated that she had not received the third dose of GARDASIL yet because she thought that she was supposed to receive the third dose of GARDASIL six months after her second dose. No adverse effect reported. No further information was provided. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a nurse concerning a multiple unspecified patients unknown ages and gender. Medical history and concurrent conditions were not reported. The reporter refers that multiple unspecified patients received MMR II that went through an unsupported temperature excursion on 20-NOV-2013 and another unsupported temperature excursion on 02-JAN-2014. No adverse effects reported. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: HEPA
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown demographics. The patient's current conditions or medical history were not reported. On 12-JUN-2007, the patient was vaccinated with the first dose of VAQTA 25/0.5 U/ml (route, indication, lot and expiration date were not reported). On 16-JAN-2008, the patient was vaccinated with the second dose of VAQTA 25/0.5 U/ml (route, indication, lot and expiration date were not reported). On 16-JAN-2014, the patient received a third dose of VAQTA 25/0.5 U/ml (route, indication, lot and expiration date were not reported). No adverse symptoms were reported. Follow-up information was received from the medical assistant regarding the 10 year old, female patient. The patient had tonsillitis at time of vaccination. On 16-JAN-2014 at 08:50 am the patient was vaccinated with the third dose of VAQTA (intramuscular, dose no 3 lot no. H012669 EXP 17-APR-2015) at a private doctor's office/hospital. It was reported that the provider order RECOMBIVAX HB, nurse gave VAQTA. The error was noticed before the patient left the office and correct immunization was given. The same day at 08:58 am the patient received RECOMBIVAX HB (intramuscular, left deltoid, dose 1; lot number J006511 EXP 28-JAN-2016: dosage unknown). The patient did not seek medical attention. The patient had no adverse reaction. Additional information is not expected.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Pt received Herpes Zoster vaccine 3/5/14 called to report 4" diameter swelling, redness, itching at injection site on 3/7/14. Reports reaction cont. through weekend with 5" diameter and heat. As of 3/10/14 reaction to 2 inches, no redness or itching.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Dehydration, Syncope
Clinical narrative: Syncope at school on 3/12/14 no aura, no orthostatic symptoms revived by pain response. Paramedics came. Evaluated at ER. Thought secondary to dehydration.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Vaccination error
Clinical narrative: Rotavirus given in error. Verbal discharge info given to patient by doctor on 1-16-2014 that pt had been given all 2 month vaccines. She did not name individual immuns due to vaccines given on day of discharge assumed rotavirus included.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Hypoaesthesia, Throat irritation
Clinical narrative: 10:30 AM - 15 min after administration, pt said she felt numb and had scratch throat. Administered 50mg IM BENADRYL and sx had completely resolved by 30 minutes later.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a Medical assistant refers to a patient of unknown demography. On 20-NOV-2013, the patient was vaccinated with the first dose of GARDASIL (dose, route and frequency were not reported). On 23-DEC-2013, the patient was vaccinated with the second dose of GARDASIL (dose, route and frequency were not reported). No adverse effects reported. No further information provided. Additional information has been requested.
Age: 1.26
Sex: F
Vaccine: FLU3, MMR, PNC13
Symptoms: Convulsion, Diabetes mellitus, Pyrexia
Clinical narrative: Had seizure activity hrs after receiving MMR/PCV and flu vaccination. The patient had slight fever 99 degrees F and diagnosed with DM and amoxicillin was prescribed child was taken to ED, given ibuprofen and discharged.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Extreme redness, swelling and pain in (L) arm, extending from shoulder to below elbow. Required E.R. visit. Mom described it as "looked like his arm would explode."