chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.18
Sex: F
Vaccine: DTAP, HIBV, RVX
Symptoms: Aphagia, Convulsion, Insomnia, Screaming
Clinical narrative: Mild seizure activity.  It began approximately an hour after we got home from receiving the vaccinations.  She would throw her arms up and kick her legs up very much like she couldn't control it, all while screaming.  She couldn't eat or sleep for more then 8 hours.  It was almost like her central nervous system was just going haywire.  She had this happen every 30 seconds - 2 minutes for the rest of the night.  Within a week, she had returned to not doing this any longer.
Age: 11.0
Sex: M
Vaccine: HPVX
Symptoms: Erythema, Oedema peripheral, Skin warm
Clinical narrative: My son's arm was red, swollen, hot and 4 times the size of his other arm. I took him to an urgent care for examination. He was able to abduct his arm about 20 degrees.
Age: 10.0
Sex: M
Vaccine: TDAP
Symptoms: Abdominal pain upper, Cough, Dyspnoea, Oropharyngeal pain, Pain
Clinical narrative: Very high fever, aching, sore throat, wheezing, throwing up, stomach pain, cough, trouble breathing.
Age: 10.0
Sex: M
Vaccine: TDAP
Symptoms: Pyrexia, Vomiting, Wheezing
Clinical narrative: Very high fever, aching, sore throat, wheezing, throwing up, stomach pain, cough, trouble breathing.
Age: 27.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Headache, Pyrexia, Rash
Clinical narrative: After two weeks from receiving typhoid, smallpox and anthrax, experienced headaches, slight fever, and rash. Rash is localized to ankles, waist, forearms, chest and face.
Age: 20.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Pallor
Clinical narrative: Patient started getting pale and dizzy.  He was instructed to lie down and rest for a period of time.  He rested for about 20 minutes and was feeling better.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Rash, Vomiting
Clinical narrative: RASH ON SEVERAL PARTS OF BODY (LEGS, STOMACH, NECK, THIGHS), THROWING UP ALOT CANNOT HOLD ANYTHING DOWN, HEADACHES.
Age: 1.1
Sex: F
Vaccine: MMR
Symptoms: Pyrexia
Clinical narrative: This spontaneous report as received from the mother of the patient refers to her 13 month old (currently 15 year old) daughter. On an unspecified date in 1999 the patient was vaccinated with a dose of M-M-R II (lot #, expiration, dose, route unspecified). In 1999 (exact date unspecified) within a few hours she developed a very high fever. None lab diagnostics studies performed. The patient had not sought medical attention. TYLENOL was given every 2 hours for treatment. The patient had not medical conditions at the time of the adverse event. The patient was taking no other medications at the time of vaccination. The patient currently has no medical conditions. At the time of report, the event outcome was reported as recovered. The patient did not seek medical attention. Additional information is not expected.
Age: 26.0
Sex: F
Vaccine: VARCEL
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 26 year old female patient. On 08-AUG-2013 the patient was vaccinated with the second dose of 0.5 ml VARIVAX (Merck) (lot # 669680/0669AA, expiration 05-MAY-2013), subcutaneously, and it was an expired dose. No adverse effects reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. On 06-AUG-2012 the patient was vaccinated with her first dose of GARDASIL (dose, route, lot # not reported), and she would receive her second dose of GARDASIL (dose, route, indication not reported) (lot # not reported) on 12-AUG-2013 )today). No adverse effect reported. Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: PPV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 12 month old patient. On 12-AUG-2013 the patient was vaccinated with a dose of 0.5 ml PNEUMOVAX23 (lot# not reported) subcutaneous. No adverse effects reported. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a community health worker concerning a 21 year old female patient. Approximately on an unknown date in 2010 (at the age of 18 years), the patient was vaccinated with the first dose of GARDASIL (lot number, expiry date, dose and route unspecified) and she was in provider office on 14-AUG-2013 to receive her second dose of GARDASIL at 21 years old. No concomitant therapy was reported. No adverse events were reported. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative
Clinical narrative: This spontaneous report was received from   a healthcare worker refers to a female patient of unknown age with no pertinent medical history and no drug reactions/allergies. The patient was vaccinated with the first dose of hepatitis B vaccine (recombinant)(manufacturer unknown) on 29-NOV-1995, the second dose on 03-JAN-1996 and the third dose on 21-AUG-1996. The patient was also vaccinated with RECOMBIVAX HB (lot # reported as J0007222, expiration: 17-SEP-2015), 0.5 ml intramuscularly on 03-AUG-2013. There was no concomitant medication. The healthcare worker reported that the patient received an unspecified hepatitis B vaccination when she was "younger" (see above dates, and on approximately 23-JUL-2013 ("about two weeks" ago) titers were drawn on the patient and the results showed that the patient was not immune. The healthcare worker reported that the patient had titers drawn because it was required for her college. The healthcare worker reported that the patient was administered RECOMBIVAX HB on 03-AUG-2013 due to her titers showing no immunity and required for college. The outcome of titer showing no immunity was unknown. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse concerning a female patient of unknown age. On 04-AUG-2009, the patient was vaccinated with the first dose of GARDASIL (lot number, expiry date and dose unspecified) intramuscularly. On 15-AUG-2013 (reported as today), the patient was vaccinated with the second dose of GARDASIL (lot number, expiry date and dose unspecified), intramuscularly which was over 4 years after she received her first dose. No concomitant therapy was reported. No adverse effects were reported. Additional information has been requested.
Age: 7.0
Sex: U
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 7 year old patient. On 08-AUG-2013 the patient was vaccinated with a dose of GARDASIL dose, frequency and route unspecified. Additional information is not expected.
Sex: M
Vaccine: HPV4
Symptoms: Erythema
Clinical narrative: This spontaneous report as received from a pharmacist refers to a male patient of unknown age. On an unknown date the patient was vaccinated with a dose of PNEUMOVAX23 (lot # H015780, Exp date 11-JUN-2014), dose and route unspecified. On an unknown date the patient developed a "larger than normal red spot on his arm" after receiving PNEUMOVAX23. Pharmacist requested that the lot#/Exp date of the specific vial of PNEUMOVAX23 that was administered to this patient be evaluated to see if the remaining doses in this multi-dose vial could be administered to other patients safely. The outcome of the patient was unknown. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This report has been received from an registered nurse who reported that an unspecified patient. On an unknown date in February 2012, on an unknown date in September 2012 and 09-AUG-2013 (today) the patient was vaccinated with the first, second and third doses of GARDASIL (lot#, dose, route, indication not reported). No known adverse effect reported. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: TDAP
Symptoms: Convulsion, Presyncope
Clinical narrative: Patient have what appear to be vasovalgal response but also noted 30 seconds of seizure activity - 911 called and patient sent to ER. Stable VS and patient and alert in route to ER.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Pruritus, Rash
Clinical narrative: 7 days after getting shot he noticed a itching, blistery rash on back of neck he felt fine otherwise (no pain, no fever, no lethargy) just itched he said it is tapering away and would contact us or see DR if get worse.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a licensed vocational nurse concerning a patient of unknown age and gender. Approximately on an unknown date in August 2012 (reported as approximately one year ago), the patient was vaccinated with the first dose of GARDASIL (lot number, expiry date, dose and route unspecified) and the patient would now like to receive a second dose of GARDASIL. No concomitant therapy was reported. No adverse symptoms were reported. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: FLU3, HEPA, MNQ, TDAP, VARCEL
Symptoms: Fall, Pallor, Syncope
Clinical narrative: Case number PHHY2013US000552 is an initial spontaneous report from vaccine adverse event reporting system (VAERS reference number: 472144) on 02 Jan 2013 with a follow-up received on 08 Aug 2013. This case refers to 11-year-old male patient. The patient was vaccinated with MENVEO (batch number: A10126) in right leg. FLUZONE (batch number: UH712AB) in left arm, BOOSTRIX (batch number: AC52B085AA) in left leg, HAVRIX (batch number: AHAVB667BB) in left leg and VARIVAX (batch number: H009635) in right leg on 27 Oct 2012. On 27 Oct 2012, after the vaccination, the patient fainted, fell out of chair and was pale. All these lasted for a minute. The physician checked his breathing and enquired how he felt. The outcome of events was reported as complete recovery as of an unspecified date. The seriousness and causality of the events was not reported. The quality assurance department stated that, based on the review performed, MENVEO batch number: A10126, was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Follow-up received from the quality assurance department (QA reference number: 208804) on 08 Aug 2013: Updated batch review report.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Hypotonic-hyporesponsive episode
Clinical narrative: Baby turned hypotonic, about 10 minutes after administration of PEDIARIX. Hypotonia lasted probably for 3-4 minutes. No H/O baby turning blue or difficulty breathing, vitals normal.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Hypotonia
Clinical narrative: Baby turned hypotonic, about 10 minutes after administration of PEDIARIX. Hypotonia lasted probably for 3-4 minutes. No H/O baby turning blue or difficulty breathing, vitals normal.
Age: 5.0
Sex: F
Vaccine: VARZOS, DTAP, IPV, MMR, VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from the office manager concerning a 5 years old female patient. The patient was allergy to AUGMENTIN. On 15-JUL-2013 at 10:00, the patient was vaccinated with the third dose of M-M-R II in the left thigh. Lot# and route was unspecified. Concomitant vaccines administered on 15-JUL-2013 at 10:00 included ZOSTAVAX, INFANRIX, and IPOL. The patient had no illness at time of vaccination. No lab test was done. There was no adverse event. The outcome of patient was reported as recovered. Patient adverse event with ZOSTAVAX was captured in 1307USA013235. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: VARZOS, DTAP, IPV, MMR, VARZOS
Symptoms: No adverse event
Clinical narrative: This spontaneous report was received from the office manager concerning a 5 years old female patient. The patient was allergy to AUGMENTIN. On 15-JUL-2013 at 10:00, the patient was vaccinated with the third dose of M-M-R II in the left thigh. Lot# and route was unspecified. Concomitant vaccines administered on 15-JUL-2013 at 10:00 included ZOSTAVAX, INFANRIX, and IPOL. The patient had no illness at time of vaccination. No lab test was done. There was no adverse event. The outcome of patient was reported as recovered. Patient adverse event with ZOSTAVAX was captured in 1307USA013235. Additional information has been requested.
Age: 16.0
Sex: M
Vaccine: MNQ, MEN, MNQ
Symptoms: Road traffic accident
Clinical narrative: After leaving the clinic - patient was involved in motor vehicle accident - later air lifted to hospital.
Age: 16.0
Sex: M
Vaccine: MNQ, MEN, MNQ
Symptoms: Hip fracture, Intensive care, Pneumothorax, Pulmonary contusion, Road traffic accident
Clinical narrative: After leaving the clinic - patient was involved in motor vehicle accident - later air lifted to hospital.
Age: 16.0
Sex: M
Vaccine: MNQ, MEN, MNQ
Symptoms: Splenic rupture, Syncope, Tibia fracture, Traumatic liver injury
Clinical narrative: After leaving the clinic - patient was involved in motor vehicle accident - later air lifted to hospital.
Age: 5.0
Sex: F
Vaccine: VARCEL, MMRV
Symptoms: Varicella post vaccine
Clinical narrative: This spontaneous report as received from a nurse refers to a 5 year old female patient. On 16-JUL-2013 the patient ws vaccinated with second dose of PROQUAD (0.5 ml, subcutaneous, site of administration not reported) (lot # H015783, exp. date. 24-FEB-2014). On 30-JUL-2013 the patient develop chickenpox like rash. The rash was evaluated in the office on 31-JUL-2013. The reporter stated that the rash was located mainly on the extremities and some of the vesicles were starting to scrap over. The outcome of chickenpox like rash was reported as recovering/resolving. The relatedness between PROQUAD and chickenpox like rash was not reported. No treatment was given for the reported adverse event. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: VARCEL, MMRV
Symptoms: Rash vesicular
Clinical narrative: This spontaneous report as received from a nurse refers to a 5 year old female patient. On 16-JUL-2013 the patient ws vaccinated with second dose of PROQUAD (0.5 ml, subcutaneous, site of administration not reported) (lot # H015783, exp. date. 24-FEB-2014). On 30-JUL-2013 the patient develop chickenpox like rash. The rash was evaluated in the office on 31-JUL-2013. The reporter stated that the rash was located mainly on the extremities and some of the vesicles were starting to scrap over. The outcome of chickenpox like rash was reported as recovering/resolving. The relatedness between PROQUAD and chickenpox like rash was not reported. No treatment was given for the reported adverse event. Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: C-reactive protein, Migraine, Nuclear magnetic resonance imaging brain, Red blood cell sedimentation rate
Clinical narrative: The most severe migraine began within 2 days of receiving a shingles vaccine on March 16, 2013. The migraine persists as of the date of filling out this form. The treatment consisted of neurological treatment with medications, trigger point injections and physical therapy acupuncture.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: C-reactive protein, Computerised tomogram, Computerised tomogram thorax, Migraine, Nuclear magnetic resonance imaging brain
Clinical narrative: The most severe migraine began within 2 days of receiving a shingles vaccine on March 16, 2013. The migraine persists as of the date of filling out this form. The treatment consisted of neurological treatment with medications, trigger point injections and physical therapy acupuncture.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Red blood cell sedimentation rate
Clinical narrative: The most severe migraine began within 2 days of receiving a shingles vaccine on March 16, 2013. The migraine persists as of the date of filling out this form. The treatment consisted of neurological treatment with medications, trigger point injections and physical therapy acupuncture.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Aphonia, Blood test normal, C-reactive protein normal, Computerised tomogram thorax normal, Lung infection
Clinical narrative: The most severe migraine began within 2 days of receiving a shingles vaccine on March 16, 2013. The migraine persists as of the date of filling out this form. The treatment consisted of neurological treatment with medications, trigger point injections and physical therapy acupuncture.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Migraine, Nuclear magnetic resonance imaging brain normal, Red blood cell sedimentation rate normal, Viral infection
Clinical narrative: The most severe migraine began within 2 days of receiving a shingles vaccine on March 16, 2013. The migraine persists as of the date of filling out this form. The treatment consisted of neurological treatment with medications, trigger point injections and physical therapy acupuncture.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pruritus
Clinical narrative: This spontaneous report was received from a female patient of unknown age regarding herself. On 25-APR-2010, the patient was diagnosed with shingles which was treated successfully with Valacyclovir hydrochloride. On 21-JUL-2010, the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiry date, dose and route unspecified). No concomitant therapy was reported. On an unknown date (reported as a few days ago), the patient again came down with shingles. But this time there were only seven small sores which were more itchy than painful and which had resolved themselves without any need of professional medical attention or drugs. She believed that ZOSTAVAX was responsible for the minor nature of this shingles attack and wished to extend her appreciation. The relatedness for shingles was unknown for ZOSTAVAX. Additional information has been requested.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Condition aggravated, Herpes zoster, Pain, Pruritus
Clinical narrative: This spontaneous report was received from a female patient of unknown age regarding herself. On 25-APR-2010, the patient was diagnosed with shingles which was treated successfully with Valacyclovir hydrochloride. On 21-JUL-2010, the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiry date, dose and route unspecified). No concomitant therapy was reported. On an unknown date (reported as a few days ago), the patient again came down with shingles. But this time there were only seven small sores which were more itchy than painful and which had resolved themselves without any need of professional medical attention or drugs. She believed that ZOSTAVAX was responsible for the minor nature of this shingles attack and wished to extend her appreciation. The relatedness for shingles was unknown for ZOSTAVAX. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: VARCEL
Symptoms: Gastrooesophageal reflux disease, Insomnia
Clinical narrative: Severe acid reflux symptoms for two weeks now, starting a few days after the second shot in the series of varicella/ chicken pox immunizations. The symptoms are making me unable to sleep at night. I have never experienced any acid reflux symptoms before this in my life.
Age: 11.0
Sex: M
Vaccine: HEPA, MNQ
Symptoms: Dyspnoea, Feeling abnormal, Local reaction, Pain in extremity
Clinical narrative: Case number PHEH2013US016985, is an initial spontaneous report received from a nurse on 08 Aug 2013. This report refers to an 11 year old male patient. His medical history and concomitant medication was not reported. He was vaccinated with MENVEO (batch number: M12113) 0.5 ml intramuscularly into left arm on an unknown date. Concomitantly he also received hepatitis A vaccine (manufacturer and batch number: unknown) into left arm. The patient reported sore arm and did not feel right the next day. Two days later, when called back, it was reported that he was taken to emergency room for trouble breathing and local reaction in left arm. Outcome of the events, seriousness and causality assessment was not reported.
Age: 76.0
Sex: U
Vaccine: VARZOS
Symptoms: Feeling hot, Rash
Clinical narrative: This spontaneous report as received from a now 76 year old patient. Above five years ago the patient received the shingles vaccine. In March 2013 the patient noticed a rash on the right side of stomach which lasted for about a month, and for a few months every so many days the patient would feel heat in my face, arms and body which would last for about twenty minutes. In May 2013 it happened eight times; last month not at all. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Healthcare Worker (also was an Office Manager) refers to an unknown number of patients of unknown age who  may have received doses of GARDASIL (start date, dose, route and lot # not reported) that was improperly stored. No adverse effects reported. This is one of several reports received from the same source. It was linked to MARRS#1308USA007998. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Wrong drug administered
Clinical narrative: This spontaneous report as received from a physician refers to a pediatric patient of unknown age. On 22-APR-2013 the patient was inadvertently vaccinated with a dose of ZOSTAVAX (dose, route and lot# not reported) rather than VARIVAX (Merck). This is one of several reports received from same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant concerning a patient of unknown age and gender. On 17-AUG-2011, the patient was vaccinated with the first dose of GARDASIL (lot number, expiry date and dose unspecified), intramuscularly. On 13-AUG-2013, the patient was vaccinated with the second dose GARDASIL (lot number, expiry date and dose unspecified), intramuscularly. No concomitant therapy was reported. No known adverse effects were reported. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a Nurse Practitioner refers to a 16 year old female patient. On 22-SEP-2008, the patient was vaccinated with first dose of GARDASIL (lot #, expiry not reported). Nurse practitioner reported that the patient was in the office today on 13-AUG-2013 to receive the second dose of GARDASIL. No adverse effect reported. Additional information has been requested.
Age: 53.0
Sex: M
Vaccine: TDAP
Symptoms: Abasia, Dyspnoea, Guillain-Barre syndrome, Paraesthesia, Walking aid user
Clinical narrative: Initial report was received from a healthcare professional on 06 August 2013. A 53-year-old male patient had received an injection of ADACEL, lot number C4424AA, on 14 June 2013 (route and site not reported). On 23 June 2013, 9 days later, the patient began to experience tingling of hands and symptoms that progressed to an inability to walk. The patient was seen at the emergency room and diagnosed with GBS. The patient was discharged to home (date not reported). On an unspecified date, the patient became worse with difficulty breathing and returned to the hospital and was admitted. The patient is currently discharged from the hospital and using a walker for ambulation. The patient had no illness at the time of vaccination and no known drug allergies. Outcome was not recovered. Documents held by sender: None.
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative
Clinical narrative: This spontaneous report as received from a healthcare worker refers to two female patient of college student age. The patients had three doses of RECOMBIVAX HB (lot number, does, route and injection site were not reported) and their titers had come back non reactive on an unknown date. Healthcare worker stated for college admissions they wanted titers drawn at the time of report, even if they had 3 doses of the vaccine. The outcome and action taken were not provided. The patients had contacted physician for medical attention. This is one of several reports received from the same source. Additional information is not expected.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Healthcare Worker (also was an Office manager) refers to an unknown number of patients of unknown age who may have received doses of RECOMBIVAX HB (start date, dose, route and lot # not reported) that was improperly stored. No adverse effects reported. This is one of several reports received from the same source. It was linked to MARRS# 1308USA007105. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 5 year old male patient. The patient was vaccinated with the first doses of VARIVAX and MMR II on an unspecified date in his infancy. On 25-APR-2013 the patient was vaccinated with the recommended second dose of VARIVAX and MMR II. The medical assistant reported that on 06-AUG-2013 this patient was administered another dose of VARIVAX (0.5ml subcutaneously, lot number and expiration date not reported and MMR II (0.5ml subcutaneously, lot number and expiration date not reported). No adverse event was reported. The patient's outcome was not provided. Additional information has been requested.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Urticaria
Clinical narrative: This spontaneous report was received from a 79 year old female patient regarding herself. Current conditions of the patient included glaucoma and asthma. It was unspecified if the patient had any drug reactions or allergies. On 09-JUL-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiry date, dose and route unspecified). Concomitant therapies included COUMADIN (dosage and manufacturer unspecified), timolol maleate (reported as Timolol) (dosage and manufacturer unspecified) and fluticasone propionate, ADVAIR (dosage unspecified). On 16-JUL-2013, the patient developed itchy welts on her body after receiving ZOSTAVAX. The patient sought medical attention (spoke with physician). The patient was treated with Prednisone (dosage and manufacturer unspecified). No lab tests were performed. The patient was not recovered from itchy welts on her body. The relatedness for itchy welts on her body was unknown for ZOSTAVAX. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a female patient of college student age. The patient was vaccinated with RECOMBIVAX HB (lot number, dose, route and injection site were not reported) at day of birth, second dose 1 month and 3 days after, and the third dose of RECOMBIVAX HB (lot number, dose, route and injection site were not reported) was administered at 7 months of age. The patient had three doses of RECOMBIVAX HB and her titers had come back non reactive on an unknown date. Healthcare worker stated for college admissions they wanted titers drawn at the time of report, even if she had 3 doses of the vaccine. The outcome and action taken were not provided. The patients had contacted physician for medical attention. This is one of several reports received from the same source. Additional information is not expected.
Sex: M
Vaccine: MEA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a patient of unknown age. On 01-AUG-2008, the patient was vaccinated with a dose of MERUVAX II (lot number, expiry date and route was not reported). Other suspect therapies included MUMPSVAX on 25-JUL-2008 (lot number, expiry date and route was not reported) and ATTENUVAX (lot number, expiry date and route was not reported) on 29-AUG-2008. No adverse experience was reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Varicella
Clinical narrative: This spontaneous report as received from a male patient via a healthcare worker refers to a female patient of unknown age. On an unknown date the female patient was vaccinated with a dose of ZOSTAVAX (lot#, dose, frequency and route unspecified) for unknown indication. The patient developed chickenpox after receiving ZOSTAVAX. The reporter stated that this female patient was not seen by their office. The outcome of the event was unknown. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a mother refers to a patient of unknown age. The reported stated that GARDASIL (dose, route and lot# unknown) was administered to the patient on the following dates: first shot on 30-JUN-2010, second shot on 28-OCT-2010 and the third sot on 21-DEC-2010. This was an other than indicated dosage schedule. No adverse events were reported.  Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from Licensed Practical Nurse refers to a female patient of unknown age. On 19-SEP-2012 the patient was vaccinated with the first dose of GARDASIL (lot # not reported) strength not reported, dose: 0.5 ml, intramuscular. On 03-AUG-2013 the patient was vaccinated with the second dose of GARDASIL (lot# not reported) strength not reported, dose: 0.5 ml, intramuscular. No adverse effect reported. The outcome of event was unknown. Product Quality Complaint (PQC) was not involved. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Drug administration error, No adverse event, Product packaging issue
Clinical narrative: This spontaneous report as received from a nurse refers to 12 patients of unknown age and gender. The nurse reported that 12 doses of oral ROTATEQ were administered to 12 unspecified patients on unspecified dates, that may or may not have been contained in partially or completely unsealed foil pouches. The nurse was not certain how many of the 12 doses of oral ROTATEQ that were administered may have been contained in partially or completely unsealed foil pouches, but she was certain that no adverse experience had been observed or reported. Of the remaining 13 doses of oral ROTATEQ from that carton, 4 doses were contained in a foil pouch that was partially sealed on one end and 3 doses were contained in a foil pouch that was completely open on one end. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site mass, Injection site pain
Clinical narrative: This spontaneous report was received from a 60 year old female patient via an unidentified employee in the ZOSTAVAX rebate program regarding herself. On 13-MAY-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot #, expiry not reported). On approximately 14-MAY-2013 a day or two after having received the shot, the patient experienced an injection-site reaction to ZOSTAVAX. The reaction was a red, sore lump the size of a half dollar. The outcome of the events were unknown. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: This spontaneous report was received from a healthcare worker regarding her daughter of unknown age. On an unknown date, the patient was vaccinated with a dose of VARIVAX (Merck). It is unclear whether the patient received one or two doses of VARIVAX (Merck) (lot#, expiry not reported). On an unknown date, the patient was diagnosed with chickenpox after receiving VARIVAX. The outcome of chickenpox was unknown. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV2
Symptoms: Dizziness, Dysarthria, Slow response to stimuli
Clinical narrative: This spontaneous report as received from a treating physician (M.D.) via a company representative refers to a 12 year old female patient. On 05-AUG-2013 the patient was vaccinated with the second dose of GARDASIL (lot # J003727, expiry date 07-NOV-2015), route reported as injection (dose not specified). She was seen at the Emergency Room of an unspecified hospital that same evening (05-AUG-2013) with symptoms of dizziness, slurred speech and slow response to stimuli. The patient ws not kept overnight. on 06-AUG-2013 the slurred speech returned and the physician was contacted by the Parent. The patient was seen at the office of the physician again. The symptoms resolved after being given carbohydrates (unspecified), GATORADE to drink. It was not stated whether or not a third shot of GARDASIL would be given. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to 6 unspecified patients received doses of RECOMBIVAX HB (lot H010380, exp 18-NOV-2014) on unspecified dates, that were exposed to an unsupported temperature excursion (28.8F for 8 minutes) on an unspecified date in May 2013. No adverse effect reported. This is one of several reports received from the same source(related case # 1308USA05499). Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse concerning a patient of unknown age and gender. It was reported that on an unknown date, an improperly stored dose of VARIVAX (Merck) (lot number, expiry date, dose and route unspecified) that was exposed to 6 degree Fahrenheit (F) consistently for 6 months for about 5000 hours may have been administered to the patient (also reported as it was unknown if the VARIVAX was administered or not). No concomitant therapy was reported. No adverse effect was reported. Additional information has been requested.
Age: 91.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pain in extremity
Clinical narrative: Saw pt. Arm was red, hot and swollen around injection site. Sore arm.
Age: 0.19
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Crying
Clinical narrative: Patient with high pitch cry which started 4 hours after immunization.
Age: 11.0
Sex: M
Vaccine: HEPA, HPV4, MNQ
Symptoms: Condition aggravated, Convulsion
Clinical narrative: Approx: 4-5 mins after giving injections pt had seizure involving all extremities lasting less than one min. Pt layed down cold compress applied to forehead O2 given to pt. Pt remained in our office for 1 hr after.
Age: 60.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Bursitis, Cellulitis, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient stated presented to ER with redness, swelling, pain in arm where vaccinations were given day after were administered - patient was admitted to hospital, however, physician diagnosed as bursitis/cellulitis.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Injection site cellulitis, Injection site erythema, Injection site induration, Injection site inflammation, Injection site pruritus
Clinical narrative: Site of the subcutaneous varicella #2 injection was inflamed red and itched a little, 24 hours after receiving the vaccine. At 48 hours post-vaccination, the indurated area was increasing so we prescribed antibiotics for presumed cellulitis on 8/14/13.
Age: 20.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Hyperhidrosis, Loss of consciousness, Pallor, Presyncope, Unresponsive to stimuli
Clinical narrative: Pt received MENVEO adn Lt forearm PPD and was sittign in chair waiting x during after 5 mins patient became pale and passed out in chair, unresponsive - sweaty. Pt came to tx and laid in Trendleburg and vital signs done 9:27 am 108/60 pulse 53 resp 16 temp 97.5 po. Last vitals at 0955 BP111/5 > pulse 68 resp 14 O2 sat 99%. Pt was pinl and warm and skin dry. Seen and spoke with mom and patient felt it was a vasovagal reaction (Pt had eaten and drank that morning prior to visit) Pt left in care of mom drinking more water.
Age: 20.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Hyperhidrosis, Hypotension, Loss of consciousness, Pallor, Presyncope
Clinical narrative: Pt received MENVEO adn Lt forearm PPD and was sittign in chair waiting x during after 5 mins patient became pale and passed out in chair, unresponsive - sweaty. Pt came to tx and laid in Trendleburg and vital signs done 9:27 am 108/60 pulse 53 resp 16 temp 97.5 po. Last vitals at 0955 BP111/5 > pulse 68 resp 14 O2 sat 99%. Pt was pinl and warm and skin dry. Seen and spoke with mom and patient felt it was a vasovagal reaction (Pt had eaten and drank that morning prior to visit) Pt left in care of mom drinking more water.
Age: 20.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Unresponsive to stimuli
Clinical narrative: Pt received MENVEO adn Lt forearm PPD and was sittign in chair waiting x during after 5 mins patient became pale and passed out in chair, unresponsive - sweaty. Pt came to tx and laid in Trendleburg and vital signs done 9:27 am 108/60 pulse 53 resp 16 temp 97.5 po. Last vitals at 0955 BP111/5 > pulse 68 resp 14 O2 sat 99%. Pt was pinl and warm and skin dry. Seen and spoke with mom and patient felt it was a vasovagal reaction (Pt had eaten and drank that morning prior to visit) Pt left in care of mom drinking more water.
Age: 56.0
Sex: F
Vaccine: HEPAB, TYP, HEPAB, TYP
Symptoms: Dyspnoea, Rash
Clinical narrative: Rec. TWINRIX (Hep A/B) in Right deltoid, Typhoid Vi (L) deltoid on 8/6/2013. Several hrs. later developed - SOB - ER - BENADRYL, discharged developed rash later in day - ER and admitted as of 8/9/2013 - still hospitalized. NKDA.
Age: 56.0
Sex: F
Vaccine: HEPAB, TYP, HEPAB, TYP
Symptoms: Anaphylactoid reaction
Clinical narrative: Rec. TWINRIX (Hep A/B) in Right deltoid, Typhoid Vi (L) deltoid on 8/6/2013. Several hrs. later developed - SOB - ER - BENADRYL, discharged developed rash later in day - ER and admitted as of 8/9/2013 - still hospitalized. NKDA.
Age: 62.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Headache, Injection site erythema, Injection site swelling, Pain, Pyrexia
Clinical narrative: Fever (peaked at 101.4). Body aches. Headache. Redness and swelling at injection site. Improving after 2 days.
Age: 26.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Induration, Injection site reaction, Local reaction
Clinical narrative: Localized reaction, RUE (deltoid) at the site of injection. Elliptical redness (80x60 mm) with central area of induration (35x25 mm). (-) Vesicles, (-) Lymphangitis. No distal involvement.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Urticaria, Vaccination complication, Wheezing
Clinical narrative: Pt was in exam 2 room, I administrated the four years old vaccines DTaP MMR in left thigh and Polio, Varicella in right thigh at 10:40 am. 10 mins later patient had a reaction to vaccines, breaking out in hives associated with wheezing.
Age: 3.0
Sex: F
Vaccine: DTAP, MMR, VARCEL
Symptoms: Convulsion
Clinical narrative: Patient received DTaP vaccine on 10/5/09. On 10/14/19 developed seizure activity and was diagnosed with a seizure disorder. Received DTaP vaccine again 10/26/12 and had s subsequent generalized seizure on 10/27/12.
Age: 4.0
Sex: M
Vaccine: IPV, TDAP
Symptoms: Wrong drug administered
Clinical narrative: Tdap was inadvertently administered instead of DTaP.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site reaction, Injection site warmth, Urticaria
Clinical narrative: Patient developed a red, itchy, warm welt at the site of injection. Patient called MD who advised patient to use cold compresses and acetaminophen.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site vesicles, Injection site warmth
Clinical narrative: Child had bliters on left arm around injection site. About 2 inches in diameter. Was warm to touch. Was taken to Pediatrician Dr. at hospital was treated with BENADRYL and BENADRYL cream.
Age: 16.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Unevaluable event
Clinical narrative: No adverse reaction.
Age: 12.0
Sex: U
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Pruritus
Clinical narrative: Redness and swelling on (R) deltoid where injection was given, complains of itchiness.
Age: 4.0
Sex: M
Vaccine: DTAPHEPBIP, IPV, MMR, VARCEL
Symptoms: Rash, Rash morbilliform, Rash papular, Streptococcus test negative
Clinical narrative: A day following vaccination, patient developed a non-pruritic fine papular rash starting in head and spreading caudally to trunk. He remained afebrile - rash lasted for about 6 days. Diagnosis: meales like rash.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Axonal neuropathy, Blood heavy metal test, Blood test, Burning sensation, Chest X-ray
Clinical narrative: Diagnosed with painful small fiber axonal neuropathy. Burning, tingling, electric-like feeling a few weeks after the shot in both feet. Then moved to tops of feet, then ankles and calves next few weeks. Currently also in fingertips. Treatment - B12 shots 1x a month, gabapentin.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Electromyogram, Nuclear magnetic resonance imaging, Paraesthesia, Urine analysis
Clinical narrative: Diagnosed with painful small fiber axonal neuropathy. Burning, tingling, electric-like feeling a few weeks after the shot in both feet. Then moved to tops of feet, then ankles and calves next few weeks. Currently also in fingertips. Treatment - B12 shots 1x a month, gabapentin.
Age: 2.0
Sex: M
Vaccine: DTAPIPV, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: No adverse event
Clinical narrative: No adverse event reported.
Age: 4.0
Sex: M
Vaccine: FLUN4, FLUN4
Symptoms: Pyrexia, Sneezing
Clinical narrative: Dad states that patient has a 101F fever and sneezing today (8/19/13). Dad did not specify time symptoms occurred.
Age: 4.0
Sex: M
Vaccine: FLUN4, FLUN4
Symptoms: Body temperature increased, Rhinorrhoea, Sneezing
Clinical narrative: Dad states that patient has a 101F fever and sneezing today (8/19/13). Dad did not specify time symptoms occurred.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Dyspnoea, Pharyngeal oedema
Clinical narrative: C/o dyspnea and "throat feeling like swelling"; Increased BP 180/100 when returning with symptoms but 100/60 before with physical; O2 sat 98-100%, BP readings 150/100, 150/94 140/94. 146/102 - told to follow up Monday and no football until recheck but didn't keep appt 8-12-13.
Age: 80.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pain in extremity
Clinical narrative: Pt. called and said injection site was swollen, hot and red. Sore arm.
Age: 1.04
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Erythema, Rash morbilliform, Skin lesion
Clinical narrative: 12 mo seen for WCC - healthy - developed a "small red circular" lesion in face that spread to trunk. Patient never seen. Mother called with concerns. No fever, no change in appetite and energy level. Non-pruritic. Diagnosis: measles-like reaction.
Age: 73.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Local swelling, Pruritus
Clinical narrative: 15 x 20 cm of erythema swelling itching.
Age: 36.0
Sex: M
Vaccine: PPV
Symptoms: Hyperhidrosis, Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Fever, sweating, pain, redness, and swelling at injuection site.
Age: 42.0
Sex: F
Vaccine: DTAP
Symptoms: Bursitis, Chills, Mobility decreased, Pain, Pain in extremity
Clinical narrative: Extreme arm pain, body aches, uncontrolled shivering/shaking.  Called physician on call and told to take Benadryl. The next 2 days had low-grade fever. Over next 2 weeks worsening of arm pain and limited movement. Went to orthopedic and diagnosed with bursitis in left shoulder.
Age: 42.0
Sex: F
Vaccine: DTAP
Symptoms: Pyrexia
Clinical narrative: Extreme arm pain, body aches, uncontrolled shivering/shaking.  Called physician on call and told to take Benadryl. The next 2 days had low-grade fever. Over next 2 weeks worsening of arm pain and limited movement. Went to orthopedic and diagnosed with bursitis in left shoulder.
Age: 23.0
Sex: F
Vaccine: RAB
Symptoms: Pruritus generalised, Rash generalised, Swelling, Urticaria
Clinical narrative: HIVES, ITCHING /SWELLS/RASHES EVERY WHERE/ 90%//
Age: 1.18
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Pyrexia, Rash generalised, Rash morbilliform
Clinical narrative: Fever 102.8 starting 7/23/2013. Rash developed 7/27/2013. Morbilliform pink rash involving entire body.
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Chills, Fatigue, Headache, Nausea
Clinical narrative: ~ 14 hours post vaccination, developed intense symptoms: headache, fever (101.3), intense chills, joint pain, all over body aches, fatigue and nausea.  All lasted for 48 hours; began resolving slowly.  Missed 2 days work as a nurse manager, mostly due to joint pain and nausea.  No local reaction present, no rash, no lymph involvment or diarrhea.
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Pain, Pyrexia
Clinical narrative: ~ 14 hours post vaccination, developed intense symptoms: headache, fever (101.3), intense chills, joint pain, all over body aches, fatigue and nausea.  All lasted for 48 hours; began resolving slowly.  Missed 2 days work as a nurse manager, mostly due to joint pain and nausea.  No local reaction present, no rash, no lymph involvment or diarrhea.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Body temperature increased, Erythema
Clinical narrative: Verbalized today had redness same day as vaccine and was worse the next day. Low grade temp. Verbalized redness to elbow. Was seen by ARNP. Antibiotics prescribed.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Chills, Headache, Hyperhidrosis, Pain, Pyrexia
Clinical narrative: Woke up with 102.5 degF fever, chills, sweating, body aches, headache, treated with Motrin. By 6/4/13 evening untreated fever was around 99 degF, still with mild body aches and headache. No additional sypmtoms appeared. Constant headache lasted a couple days. Headache was intermittent for a couple of weeks.
Age: 5.0
Sex: M
Vaccine: HEPA, HIBV, MMR, VARCEL
Symptoms: Incorrect dose administered, Wrong technique in drug usage process
Clinical narrative: MA visiting from clinic. MA gave 4 yr. vaccinations to pt. Another MA found boc if Hib to have one bottle of Hib powder but no diluent. MA last MA known to give Hib. Site Mgr. questioned MA about reconstitution of Hib. MA stated used diluent on fridge door (Sterile water for MMR/Varicella) to reconstitute Hib. MA stated she did not know there was diluent in the same box as the Hib powder. Recontituted incorrectly. Notified Health dept. informed needs to be regiven. Parent notified of error 8/16/13. Vaccine reconstitued correctly and given to the pt.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Headache, Myalgia, Nausea, Pallor
Clinical narrative: Moderate reaction including dizziness, nausea, paleness, muscle aches and bad headache.  No treatment.  8/18/2013 symptoms continued and 8/19/13 started to subside.