chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: F
Vaccine: PPV, PPV, PPV
Symptoms: Computerised tomogram normal, Cough, Dizziness, Dyspnoea, Fatigue
Clinical narrative: This spontaneous report as received from a consumer refers to a 66 year old female patient with tobacco allergy. Prior, patient's sister experienced illness with respiratory distress on 16-Jan-2013, one day after vaccination with PNEUMOVAX23 (linked case 1308USA014836). On 15-AUG-2013 the patient was vaccinated with PNEUMOVAX23 lot # J002646. Dosing information and route of administration were not provided. On 16-AUG-2013 (reported as the following day) the patient experienced severe coughing episodes, dry heaves, vomiting, wheezing and excessive mucus production. Additional symptoms included difficulty in breathing, blurred vision and dizziness. Treatment was sought through patient's physician in the form of "PREGNAZONE" (Watson labs brand), at an unspecified dosage and frequency and an unspecified "Z-PACK" antibiotic course. The adverse symptoms had not improved and patient had been forced to cancel her vacation and seek additional help of a pulmonologist. It was reported that an X-ray and computed tomography (CT) scan were performed on 26-AUG-2013. Causality assessment was not provided. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: PPV, PPV, PPV
Symptoms: Feeling abnormal, Hypoacusis, Immune system disorder, Increased upper airway secretion, Insomnia
Clinical narrative: This spontaneous report as received from a consumer refers to a 66 year old female patient with tobacco allergy. Prior, patient's sister experienced illness with respiratory distress on 16-Jan-2013, one day after vaccination with PNEUMOVAX23 (linked case 1308USA014836). On 15-AUG-2013 the patient was vaccinated with PNEUMOVAX23 lot # J002646. Dosing information and route of administration were not provided. On 16-AUG-2013 (reported as the following day) the patient experienced severe coughing episodes, dry heaves, vomiting, wheezing and excessive mucus production. Additional symptoms included difficulty in breathing, blurred vision and dizziness. Treatment was sought through patient's physician in the form of "PREGNAZONE" (Watson labs brand), at an unspecified dosage and frequency and an unspecified "Z-PACK" antibiotic course. The adverse symptoms had not improved and patient had been forced to cancel her vacation and seek additional help of a pulmonologist. It was reported that an X-ray and computed tomography (CT) scan were performed on 26-AUG-2013. Causality assessment was not provided. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: PPV, PPV, PPV
Symptoms: Pyrexia, Respiration abnormal, Retching, Speech disorder, Vision blurred
Clinical narrative: This spontaneous report as received from a consumer refers to a 66 year old female patient with tobacco allergy. Prior, patient's sister experienced illness with respiratory distress on 16-Jan-2013, one day after vaccination with PNEUMOVAX23 (linked case 1308USA014836). On 15-AUG-2013 the patient was vaccinated with PNEUMOVAX23 lot # J002646. Dosing information and route of administration were not provided. On 16-AUG-2013 (reported as the following day) the patient experienced severe coughing episodes, dry heaves, vomiting, wheezing and excessive mucus production. Additional symptoms included difficulty in breathing, blurred vision and dizziness. Treatment was sought through patient's physician in the form of "PREGNAZONE" (Watson labs brand), at an unspecified dosage and frequency and an unspecified "Z-PACK" antibiotic course. The adverse symptoms had not improved and patient had been forced to cancel her vacation and seek additional help of a pulmonologist. It was reported that an X-ray and computed tomography (CT) scan were performed on 26-AUG-2013. Causality assessment was not provided. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: PPV, PPV, PPV
Symptoms: Vomiting, Wheezing, X-ray
Clinical narrative: This spontaneous report as received from a consumer refers to a 66 year old female patient with tobacco allergy. Prior, patient's sister experienced illness with respiratory distress on 16-Jan-2013, one day after vaccination with PNEUMOVAX23 (linked case 1308USA014836). On 15-AUG-2013 the patient was vaccinated with PNEUMOVAX23 lot # J002646. Dosing information and route of administration were not provided. On 16-AUG-2013 (reported as the following day) the patient experienced severe coughing episodes, dry heaves, vomiting, wheezing and excessive mucus production. Additional symptoms included difficulty in breathing, blurred vision and dizziness. Treatment was sought through patient's physician in the form of "PREGNAZONE" (Watson labs brand), at an unspecified dosage and frequency and an unspecified "Z-PACK" antibiotic course. The adverse symptoms had not improved and patient had been forced to cancel her vacation and seek additional help of a pulmonologist. It was reported that an X-ray and computed tomography (CT) scan were performed on 26-AUG-2013. Causality assessment was not provided. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Injection site pain, Neck pain, Pain
Clinical narrative: The day after the vaccine in her right deltoid, she started developing sharp shooting pains in her right shoulder and up to her right neck. 3 days later she developed painful blisters. I diagnosed her with shingles and provided her with 7 days of Valtrex 1g BID and Tylenol #3 for pain. On 8/26/13 she called still with severe pain and I provided her with Neurontin 300mg TID prn pain and more Tylenol #3. I have not heard from her since. She refused to come in because of the cost of the doctor visit, but we did recommend she get seen by a doctor.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV
Symptoms: Apnoea, Bradycardia, Continuous positive airway pressure
Clinical narrative: Apnea and bradycardia requiring positive pressure ventilation.
Age: 0.59
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC
Symptoms: Death
Clinical narrative: Death.
Age: 25.0
Sex: F
Vaccine: TYP
Symptoms: Activities of daily living impaired, Dizziness, Fatigue, Menstruation delayed
Clinical narrative: Extreme fatigue, some dizziness, lasted for multiple days.  Not bad enough to skip work but was not very productive during, avoided extra activities and slept instead.  Also delayed my period by 7 days.
Age: 12.0
Sex: F
Vaccine: HEP
Symptoms: Abasia, Dyspnoea, Hypoaesthesia, Multiple sclerosis, Paraesthesia
Clinical narrative: Patient lost use of legs in AM after Hep B shot/ resolved shortly after. small symptoms arose since culminating in diagnosis of MS on 11/11/2011. First main defining symptom was on 9/22/10 @ facility/ tingling down leg when neck is extended, vaginal numbness, shortness of breath.
Age: 12.0
Sex: F
Vaccine: HEP
Symptoms: Vision blurred
Clinical narrative: Patient lost use of legs in AM after Hep B shot/ resolved shortly after. small symptoms arose since culminating in diagnosis of MS on 11/11/2011. First main defining symptom was on 9/22/10 @ facility/ tingling down leg when neck is extended, vaginal numbness, shortness of breath.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Convulsion, Hypotonia, Staring, Syncope, Urinary incontinence
Clinical narrative: This spontaneous report was received from a physician via a company representative concerning a 12 year old female patient with no pertinent medical history and no drug reactions or allergies. On an unknown date, the patient was vaccinated with the first dose of GARDASIL (lot number, expiry date, dose and route unspecified). On 27-AUG-2013, the patient was vaccinated with the second dose of GARDASIL (lot number, expiry date, dose and route unspecified). There were no concomitant medications. On 27-AUG-2013, a few minutes after receiving the vaccination, the patient had a glazed look and her arm went limp. The patient also either fainted or had a seizure (exact diagnosis was unspecified as the physician did not know which one was the diagnosis for the patient). The patient then urinated on herself. The patient was monitored for 30 minutes. No treatment was provided. No lab tests were performed. On 27-AUG-2013, the patient was recovered from all the events. The relatedness for all the events was unknown for GARDASIL. Upon internal review the seizure was considered as medically significant. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Malaise, Respiratory distress
Clinical narrative: This spontaneous report as received from a consumer (patient's sister) refers to a 61 year old female patient. On 10-JAN-2013 the patient was vaccinated with PNEUMOVAX23. Dosing information, route of administration and lot number were not provided. On 11-JAN-2013 (reported as the following day) the patient became very ill with respiratory distress. The patient was hospitalized. The patient eventually entered a nursing facility and her adverse respiratory symptoms continued. Outcome of "very ill" was not reported. Causality assessment was not provided. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: VARCEL
Symptoms: Expired drug administered, Injection site induration, Injection site swelling, Injection site warmth, Muscle contusion
Clinical narrative: This spontaneous report as received from registered nurse refers to a 15 year old female patient, with none pertinent medical history. On 16-OCT-2012, the patient was vaccinated with a dose of VARIVAX (Merck) (Lot # H006536, exp date 09-MAR-2014) (dose and route not reported). Other suspect therapies included sterile diluent that was used to reconstitute the VARIVAX (Merck) (Lot # 6104Y, exp date February 2012). There was no concomitant therapy. On 18-OCT-2012, the patient's mother reported that the vaccine site was swollen to the size of a grapefruit, warm and hard to the touch. The patient was examined by an unspecified physician on 19-OCT-2012 and 27-OCT-2012. The nurse stated that the unspecified physician stated the adverse symptoms were not an infection and they were probably the result of a bruised muscle. The nurse reported that the VARIVAX (Merck) that was administered was reconstituted with sterile diluent that had expired on an unspecified date in February 2012. No treatment was given for the adverse events. Laboratory diagnostic studies were not performed. It was reported that the patient recovered from the adverse events on 07-NOV-2012. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Unevaluable event
Clinical narrative: A customer had submitted the following question(s) on MerckVaccines.com on 10-AUG-2013. Direct evidene of vaccine induced food allergies: Most anaphylactic reactions and some urticarial reactions to gelatin-containing measles, mumps, and rubella monovalent vaccines are associated with IgEmediated gelatin alelrgy. DTaP (diphtheria, tetanus, pertussis) immunization histories suggest that the gelatin-containing DTaP (diphtheria, tetanus, pertussis) vaccine may have a causal relationship to the development of this gelatin allergy. Why do you still make vaccines that contain food proteins): Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Pain in extremity
Clinical narrative: This spontaneous report as received from a registered nurse via a company representative reported that numerous patients (number unspecified) developed a sore arm following the first dose of GARDASIL (dose, route and lot # not reported) on unspecified dates. The patients reported to the nurse the sore arm when returned for the second dose of GARDASIL, but the arm was no longer sore (time frame development of the sore arm and time frame resolution of the sore arm were unspecified). No treatment was given for adverse event. The patients did not see medication for the event. Additional informations is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: This spontaneous report was received form a nurse practitioner via company representative refers to unspecified number patients of unknown age and gender. The nurse reported that the physician's office had unspecified number patients who were administered GARDASIL (lot # J006236, expiration date: 25-FEB-2016) route, dose and location unspecified on an unspecified date and experienced syncope. The physician inquired "is there increased risk of syncope associated with GARDASIL lot # J006236). At the time of report, the outcome of syncope was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: This spontaneous report was received from a nurse practitioner via company representative refers to unspecified number patients of unknown age and gender. The nurse reported that the physician's office had unspecified number of patients who were administered GARDASIL (lot # H021861, expiration date: 09-OCT-2015) route, dose and location unspecified on an unspecified date and experienced syncope. The physician inquired "is there increased risk of syncope associated with GARDASIL lot # H021861". At the time of report, the outcome of syncope was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster, Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report as received from an approximately 54 year old female patient with asthma, allergy to penicillin and codeine. The patient's medical history included appendix removed, back surgery, foot surgery, knee surgery, elbow surgery, rib removed, hysterectomy and bladder mesh implant. The patient reported she developed shingles and then received one dose of ZOSTAVAX "about" 2 years ago. Concomitant therapies included CLARITIN, ALLEGRA, PROAIR, ADVAIR, LEXAPRO, CRESTOR, NEURONTIN, FLEXERIL, PREMARIN, BONIVA, CHANTIX, ADVIL PM and BENADRYL. The patient reported that after receiving this dose of ZOSTAVAX she developed shingles again, and then received a second dose of ZOSTAVAX 1-2 months after receiving her first dose of ZOSTAVAX. The patient reported after receiving the second dose of ZOSTAVAX she developed shingles "last week" on about 05-AUG-2013. Patient sought medical attention by having a doctor's visit and capsaicin (unspecified manufacturer) was given for the treatment of shingles symptoms. There was no lab performed.  The outcome of shingles (after second dose of ZOSTAVAX was reported as not recovered/not resolved. Patient experienced an adverse event on the treatment of CLARITIN on an unspecified date (1308USA009902). Additional information has been requested.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Rash
Clinical narrative: Patient broke out rashes/bumps on her 2 wrists upon receiving vaccines. Took BENADRYL and it helped w/ rash and itchiness.
Age: 70.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Feeling hot, Rash erythematous, Swelling
Clinical narrative: Red rash, slight swelling, slight heat started almost immediately after injection and continued to spread up to 3 days after injection.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient who received both PROQUAD (Merck), 0.5 ml, subcutaneously and VARIVAX (Merck), 0.5 ml, subcutaneously on 02-AUG-2013. No adverse effect reported. Additional information has been requested.
Age: 0.5
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a 6 month old female patient with allergy to BIAXIN and none of pertinent medical history. On 09-APR-1993, the patient was vaccinated with first dose of hepatitis B vaccine (recombinant)(manufacturer unknown) (dose, route, lot#, injection site not provided) were administered on 11-MAY-1993 and 06-OCT-1993, respectively. The patient had titers drawn for school purposes on 17-APR-2013 that resulted negative. Therefore the now 20 years old female patient was administered RECOMBIVAX HB because of the patient's titers being negative. On 22-APR-2013 the patient was vaccinated with RECOMBIVAX HB, lot # H020605 and expiration date 12-MAR-2015 (also reported as 31-MAR-2015), dose 1, 0.5 ml, intramuscular. On 22-MAY-2013 the patient was vaccinated with RECOMBIVAX HB, lot # H017018 expiration date 11-JUL-2015, dose 2, 0.5 ml, intramuscular. Concomitant therapies included MAXALT, TOPAMAX, YAX, PROVENTIL. The patient was administered a pediatric dose of RECOMBIVAX HB for each dose. The outcome of adverse event (patient's titers negative) was unknown. The causality between Hepatitis B (Recombinant) (manufacture unknown) and adverse event (patient's titers negative) was unknown. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pt came in 9/2/13 (2 day after shot) complains of pain in injection site. Site was red pronounced bump, several inches in diameter. Recommended pt get doctor to look at site.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Blood test, Dizziness, Hypoaesthesia, Paraesthesia
Clinical narrative: This spontaneous report as received from a nurse refers to a 17 year old female patient. On 23-NOV-2007, the patient was vaccinated with the first dose of GARDASIL (lot number and expiration date were not provided), 0.5 ml, intramuscular. She was vaccinated the three dose series on an unspecified date. The nurse noted that the patient experienced an adverse experience after completing GARDASIL series on an unspecified date. The nurse reported that the patient began the GARDASIL series on 23-NOV-2007 and completed the three dose series on an unspecified date without any complications noted during the course of the vaccine series. The patient sought medical attention and came to the unspecified physician's office on 06-MAY-2011 to have an evaluation of lightheadedness and numbness and tingling "which was located in the lower half of her body, specifically her knees and legs". The unspecified physician ordered unspecified blood tests on an unspecified date to evaluate the patient's symptoms. The patient was not given treatment for events. The outcome of events was reported as recovered on 27-AUG-2013. Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Rash
Clinical narrative: Patient vaccinated on 8/31/13 with FLUZONE HD. On 9/2/13, patient reports itching and rash on arms only.
Age: 46.0
Sex: M
Vaccine: FLU3
Symptoms: Dysphonia, Local swelling, Muscle spasms, Pyrexia, Rash
Clinical narrative: Rash, slight low fever, hoarseness, pulsating on arm of vaccine, swelling of groin area, rash on lower left leg.
Sex: U
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: This spontaneous report was received from a nurse practitioner via company representative refers to unspecified number patients of unknown age and gender. The nurse reported that the physician's office had unspecified number patients who were administered GARDASIL (lot# 0459AE, expiration date unknown) route dose and location unspecified on an unspecified date and experienced syncope. The physician inquired "is there increased risk of syncope associated with GARDASIL lot # 0458AE". At the time of report, the outcome of syncope was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Dysgeusia, Migraine, Paraesthesia, Throat irritation
Clinical narrative: This spontaneous report as received from a health care worker refers to a 12 year old female patient, who is also the healthcare worker's daughter. The patient's medical history included brain cancer currently in remission. On 05-AUG-2013 the patient was vaccinated with GARDASIL dose 1, intramuscular in the left arm. Other suspect therapies included VAQTA (unspecified dose and frequency). Concomitant medication were not provided. On 07-AUG-2013, the patient experienced tingling sensations down the entire left side of her body that lasted for 5 days, weird feeling in throat, painful migraines and metallic taste in mouth. The tingling sensation stopped for five days, but then started again and persisted for another three days. A brain MRI was scheduled for an unspecified date. No treatment was given. The outcome of tingling sensations down the entire left side of her body that lasted for 5 days off and on, weird feeling in throat, painful migraines and metallic taste in mouth was not provided. Additional information has been requested.
Age: 14.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Red, swollen, and hot area directly below injection site. (Approximately 4" x 3").
Age: 10.0
Sex: U
Vaccine: VARCEL
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 10 year old patient of unknown gender. On 06-AUG-2013 the patient was vaccinated with VARIVAX (Merck) (lot number G006863 exp 20-JUL-2013), 0.5 ml, subcutaneous. On 06-AUG-2013, 1 day after onset of therapy the patient received an expired dose of VARIVAX (Merck). No adverse effects were reported. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy, Inappropriate schedule of drug administration, Pregnancy test urine positive
Clinical narrative: This spontaneous prospective pregnancy report as received from a registered nurse, refers to a 19 year old female patient with no pertinent medical history and no drug reactions or allergies. On 23-FEB-2009 the patient was vaccinated with the first dose of GARDASIL (lot number was not reported) 0.5 ml, intramuscular and on 15-JUN-2009 the patient was vaccinated with the second dose of GARDASIL (lot number was not reported) 0.5 ml, intramuscular. On 13-AUG-2013 pregnant patient was vaccinated with the third dose of GARDASIL (lot # H021861, expiration date: 09-OCT-2015), 0.5 ml, intramuscular. The patient did not use any concomitant medications. On 13-AUG-2013 the patient had a positive urine pregnancy test. The patient became pregnant with last menstrual period (LMP) of 12-JUL-2013 and estimated delivery date (EDD) of 18-APR-2014. Initial exposure to GARDASIL was at 4 weeks. The pregnancy outcome was pending. The outcome of events was unknown. Additional information has been requested.
Age: 0.34
Sex: U
Vaccine: RV5
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 4 month old patient (gender not reported). On 07-AUG-2013 the patient was vaccinated with ROTATEQ (lot # 1844AA, expiry date 01-JUN-2013) dose 2, oral. Dose was not reported. The first dose was given on 06-JUN-2013. On 07-AUG-2013 the patient received an expired dose of ROTATEQ (expiry date 01-JUN-2013). No adverse effect was reported. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a male patient of unknown age. On 28-AUG-2013 the patient was inadvertently vaccinated with ZOSTAVAX, vial, subcutaneous (dose, location and application site unspecified) (lot # and exp date unknown). After administration it was discovered that the patient had additional medical information, which was not disclosed prior to receiving ZOSTAVAX, which documented that he had ZOSTAVAX sometime in 2007. No adverse effects were reported. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This spontaneous prospective pregnancy report as received from a physician, via company representative, refers to a 16 year old female patient. On an unknown date the patient was vaccinated with GARDASIL (dose, lot number and route were not reported). Concomitant medications were not reported. According to the physician, the patient who received all three doses in the GARDASIL series, received an unspecified number of these doses during pregnancy. There was no adverse experience reported except for the pregnancy. The Last Menstrual Period (LMP) and Estimated date of deliver (EDD) was not know. The pregnancy outcome was unknown. Patient sought medical attention, spoke with the physician. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from license practical nurse refers to a patient of unknown age and gender. On 27-JUL-2012 the patient was vaccinated with the first dose of GARDASIL (Lot #, dose and route not reported). On 27-AUG-2013 the patient was in the provider's office to receive the second dose in the GARDASIL series. Concomitant therapy was not reported. No adverse event 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 as received from nurse practitioner (N.P), refers to a 15 year old female patient. It was reported that when the patient had 15 years old, approximately in 2007, was vaccinated with the first dose of GARDASIL (Lot # not reported) (0.5 ml, intramuscular), in June 2013, the patient received her second dose of GARDASIL, and was currently in the office (28-AUG-2013) to receiver her third dose of GARDASIL. No adverse effect reported. Concomitant therapy was not reported. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Gastritis
Clinical narrative: This spontaneous report as received from a physician, via company representative, refers to a 62 year old female patient. On approximately 18-AUG-2013 (reported as "during the week of 18-AUG-2013") the patient was vaccinated with ZOSTAVAX (lot number and route were not reported), 0.65 ml. Concomitant medications were not reported. On approximately 25-AUG-2013 ("week of 25-AUG-2013"), the patient presented with fatigue and gastritis. The patient followed up with her. Physician through an office appointment to address her symptoms. The outcome of gastritis and fatigue was unknown. The relationship between ZOSTAVAX and the events was not reported. Additional information is not expected.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash erythematous, Rash generalised
Clinical narrative: This spontaneous report was received from a consumer's daughter, regarding to her mother, an 84 year old female patient with hypertension, a little arthritis and allergy to propylene glycol. On an unknown date approximately in 2012 report as "over a year ago" the patient was vaccinated with ZOSTAVAX (lot number and expiration date not reported) (1 shot, dose and route not reported). No other suspect therapies were reported, concomitant medications included an unspecified blood pressure pill. Approximately on 26-JUL-2012, reported as "13 months ago" after receiving ZOSTAVAX, the patient started itching and then developed a bright red rash all over her body. The patient had been to an allergist, a dermatologist and her regular physician regarding this issue. The allergist stated that the patient was allergic to propylene glycol, and her adverse reaction seemed be triggered by unspecified foods as well. This is because the patient's adverse reactions seem to become better, but then it flared up again. The outcome for itching and bright red rash all over her body was unknown at the time of the report. Treatment with BENADRYL, ZYRTEC, and CLARITIN was given to the patient. Unspecified allergy tests were taken (results not reported). Additional information is not expected.
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse, refers to a patient of unknown age and gender. The nurse reported that on an unknown date, the patient was administered expired M-M-R II (dose, route, lot number and expiration date unspecified). No adverse event reported. Concomitant medications were not reported. Additional information is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 23-AUG-2013 the patient was vaccinated with VARIVAX (Merck) (lot # G007814 and exp date reported on 16-AUG-2013) 0.5 ml, subcutaneous. No other co suspects were reported. No concomitant therapy was reported. The nurse reported that the patient received an expired dose of VARIVAX (Merck). No adverse event reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Burning sensation, Immediate post-injection reaction, Pain
Clinical narrative: This spontaneous report was received from a healthcare worker refers to an unspecified number of female children patients. On an unspecified date in 2013 ("In the last 6 months" as reported) GARDASIL (lot# unspecified) route and location unspecified has been hurting more patients during administration. Healthcare worker mentioned the patients had been experienced more pain and burning sensations immediately after administration. Healthcare worker also stated this adverse event occurred after a first, second or third dose, whatever doses the patients happened to have received at the time. The patients had sought medical attention via office visit. At the time of report, the patients had recovered from the events on unspecified date in 2013. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: M
Vaccine: HPV4
Symptoms: Burning sensation, Immediate post-injection reaction, Pain
Clinical narrative: This spontaneous report was received from a healthcare worker refers to an unspecified number of male children patients. On an unspecified date in 2013 ("In the last 6 months" as reported) GARDASIL (lot# unspecified) route and location unspecified has been hurting more patients during administration. Healthcare worker mentioned the patients had been experienced more pain and burning sensations immediately after administration. Healthcare worker   also stated this adverse event occurred after a first, second or third dose, whatever dose the patients happened to have received at the time. The patients had sought medical attention via office visit. At the time of report, the patients had recovered from the events on unspecified dates in 2013. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: VARCEL
Symptoms: Incorrect dose administered, Local swelling, Pain in extremity, Tenderness, Wheezing
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Medical assistant reported that the patient was inadvertently given a 3rd dose of VARIVAX (Merck). Concomitant medications were not reported. No adverse effect reported. Follow up information has been received from the medical assistant refers to a 12 year old male patient with deficient on several immunizations. The history drugs included Hepatitis B vaccine, Hepatitis A vaccine, HPV vaccine and MENACTRA vaccine. The lab included height was 4 feet 9 inches. Temperature was 93.1. Blood pressure was 98/52. Temperature was 98.5. Pulse was 78. Respirations were 16. General: No apparent distress. He was alert. He was talkative. Head was normocephalic and atraumatic. Eyes: Without icterus or drainage. Heart: Tones were regular. Lungs: Sounds revealed faint wheeze. Abdomen: Soft and nontender. Extremities: No cyanosis or edema. On 22-JUL-2013 the patient was vaccinated with VARIVAX (Merck) (lot # H017133, dose 3, subcutaneous in the left arm). On an unknown date the patient experienced arm were swelling and arm were sore/tender. The outcome of the adverse events 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 pharmacist refers to a patient of unknown age and gender. Sometime in 2010 the patient was vaccinated with the first dose of GARDASIL. On 26-AUG-2013 the patient was in the office to receive second dose of GARDASIL, which will be late. No symptoms were reported. Additional information has been requested.
Age: 59.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Erythema, Injection site vesicles
Clinical narrative: Pt called 9/2 at 11:10 am notified me there is a blister about 3 inches from injection site. Pt came and recommended suggest comes to ER care for "redness about 2 inches and a blister. No trouble breathing going to follow up with urgent care.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Syncope
Clinical narrative: Fainted after immunization.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Apathy, Fatigue, Grip strength decreased, Injection site pain, Pain in extremity
Clinical narrative: On 19-JUN-2013 the patient was vaccinated with GARDASIL (lot number 0420AE and expiration date: 01-DEC-2014), first dose, in the left deltoid (concentration and duration was not reported). There was also reported that patient had an unspecified birth control as a concomitant medication. No other concomitant medications were reported. On 19-JUN-2013 the patient experienced soreness at the injection site which lasted for two days and then resolved. The patient also reported that 30 minutes after the injection she experienced pain in the right upper arm and had a hard time grasping and lifting objects with the right arm. The patient reported that this lasted for a few days, then resolved on an unspecified date and she was unmotivated and fatigued for one month after the injection which at this point was also resolved and did not receive treatment for the event. There were no laboratories performed. The outcome of unmotivated, fatigued, soreness at the injection site, pain in the right upper arm and hard time grasping and lifting objects was reported as recovered/resolved. Causality between Adverse events and GARDASIL was not reported. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: FLUN3
Symptoms: Influenza like illness
Clinical narrative: A report has been received health professional concerning a 12 years old female patient. No information regarding relevant history, concomitant disease and concomitant medications were provided. Patient has been receiving Nasal FLUMIST, which was given on 06-Sep-2012. MedImmune BSS reported that the registered nurse stated that a patient experienced flu like symptoms mid Jan 2013, flu test has not been done. The patient recovered from the event of experienced flu like symptoms on an unspecified date. The reporter considered the event to be non-serious.
Age: 41.0
Sex: M
Vaccine: FLU3
Symptoms: Condition aggravated, Head injury, Presyncope, Syncope
Clinical narrative: Case number PHHY2013US000930 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 472788) website on 02 Jan 2013 with the follow-up received from Quality Assurance department (ref: 208816) on 28 Aug 2013. This case refers to a 41-year-old male patient. His medical history included vasovagal reactions in the past on unspecified dates. He was vaccinated with FLUVIRIN (batch number: 1254501) intramuscularly in left arm on 20 Oct 2012. Approximately five minutes after vaccination she suffered vasovagal reaction, fainted and hit her head on the floor. She was taken in an ambulance to hospital. She was not hospitalized. She had recovered completely. The seriousness and causality were not reported. No other information was available. QA department stated that, the reported batch number is not a valid FLUVIRIN batch number. Therefore this case would be treated as an unknown batch number and QA investigation will not be performed. Follow-up received from Quality Assurance department on 28 Aug 2013: Updated QA department comments.
Age: 74.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Biopsy skin normal, Pain, Rash pruritic
Clinical narrative: This spontaneous report as received from a consumer refers to a 74 year old female patient with asthma, Chronic obstructive pulmonary disease (COPD) and also had skin allergy to an unspecified drug. On an unknown date in December 2006, the patient was vaccinated with a dose of ZOSTAVAX (Lot number, expiry date, route and dose were not reported) in the left arm. Concomitant medication included an unspecified COPD medication. Approximately on an unknown date in 2007 (reported as a few months later), the patient developed a red itchy, prickly rash around her waist. Patient sought medical attention and she went to her primary physician and it was not diagnosed as "shingles", although the patient suspected that it was the result of her receiving the vaccine. The patient had been to three separate dermatologist, and also to the infectious disease clinic and diagnosis had still not been made. The patient now had the rash all different areas of her entire body, legs, thighs, trunk, and arms with a intense itchy burning sensation. No diagnosis had been made by any of the physicians visited. On an unspecified date in 2006 a skin allergy tests were performed and the results were not provided. The patient was treated with unspecified steroids. The outcome of the reported events was not recovered/not resolved. The reporter considered the events as related to ZOSTAVAX. Additional information has been requested.
Age: 74.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Allergy test, Burning sensation, Rash erythematous, Rash generalised, Rash pruritic
Clinical narrative: This spontaneous report as received from a consumer refers to a 74 year old female patient with asthma, Chronic obstructive pulmonary disease (COPD) and also had skin allergy to an unspecified drug. On an unknown date in December 2006, the patient was vaccinated with a dose of ZOSTAVAX (Lot number, expiry date, route and dose were not reported) in the left arm. Concomitant medication included an unspecified COPD medication. Approximately on an unknown date in 2007 (reported as a few months later), the patient developed a red itchy, prickly rash around her waist. Patient sought medical attention and she went to her primary physician and it was not diagnosed as "shingles", although the patient suspected that it was the result of her receiving the vaccine. The patient had been to three separate dermatologist, and also to the infectious disease clinic and diagnosis had still not been made. The patient now had the rash all different areas of her entire body, legs, thighs, trunk, and arms with a intense itchy burning sensation. No diagnosis had been made by any of the physicians visited. On an unspecified date in 2006 a skin allergy tests were performed and the results were not provided. The patient was treated with unspecified steroids. The outcome of the reported events was not recovered/not resolved. The reporter considered the events as related to ZOSTAVAX. Additional information has been requested.
Age: 56.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site rash
Clinical narrative: This spontaneous report as received from a Doctor of Pharmacy refers to a 56 year old female patient. The patient's past relevant medical history, concomitant medications and past drug history were unknown. On 23-AUG-2013, the patient was vaccinated with one dose of ZOSTAVAX (lot # J001690, exp. date: 08-MAY-2014) 0.65 ml, subcutaneous injection in the left arm. On an unknown date, in August 2013, the patient developed a red rash at the injection site, that measures approximately 3 inches by 10 inches, this was reported to the pharmacist on 25-AUG-2013. It was unknown if there was any relevant laboratory data. On 25-AUG-2013, it was unknown if the patient continued to receive ZOSTAVAX. At the time of the report, the patient continue experiencing the red rash at the injection site, measuring 3 inches by 10 inches. Additional information has been requested.
Age: 56.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: This spontaneous report as received from a Doctor of Pharmacy refers to a 56 year old female patient. The patient's past relevant medical history, concomitant medications and past drug history were unknown. On 23-AUG-2013, the patient was vaccinated with one dose of ZOSTAVAX (lot # J001690, exp. date: 08-MAY-2014) 0.65 ml, subcutaneous injection in the left arm. On an unknown date, in August 2013, the patient developed a red rash at the injection site, that measures approximately 3 inches by 10 inches, this was reported to the pharmacist on 25-AUG-2013. It was unknown if there was any relevant laboratory data. On 25-AUG-2013, it was unknown if the patient continued to receive ZOSTAVAX. At the time of the report, the patient continue experiencing the red rash at the injection site, measuring 3 inches by 10 inches. Additional information has been requested.
Age: 0.64
Sex: F
Vaccine: DTAPHEPBIP, PNC13
Symptoms: Injection site erythema, Pyrexia
Clinical narrative: Redness to both thighs at site of injections about quarter size. Fever - 102 degrees.
Age: 67.0
Sex: F
Vaccine: HEP
Symptoms: Abdominal pain upper, Angiogram, Chest X-ray, Computerised tomogram, Computerised tomogram abdomen
Clinical narrative: At routine visit pt was given 1st injection of Hep B vaccine due to history of diabetes. One hour after receiving injection she went to the hospital ED and was admitted to the MICU with nausea, vomiting, epigastric pain, presyncope, hypotension, tachycardia, tachypnea, renal insufficiency, elevated white count. On hospital day #2 she was diagnosed with acute diverticulitis. Will probably be discharged tomorrow.
Age: 67.0
Sex: F
Vaccine: HEP
Symptoms: Culture urine, Diverticulitis, Full blood count, Hypotension, Intensive care
Clinical narrative: At routine visit pt was given 1st injection of Hep B vaccine due to history of diabetes. One hour after receiving injection she went to the hospital ED and was admitted to the MICU with nausea, vomiting, epigastric pain, presyncope, hypotension, tachycardia, tachypnea, renal insufficiency, elevated white count. On hospital day #2 she was diagnosed with acute diverticulitis. Will probably be discharged tomorrow.
Age: 67.0
Sex: F
Vaccine: HEP
Symptoms: Laboratory test, Nausea, Presyncope, Renal failure, Tachycardia
Clinical narrative: At routine visit pt was given 1st injection of Hep B vaccine due to history of diabetes. One hour after receiving injection she went to the hospital ED and was admitted to the MICU with nausea, vomiting, epigastric pain, presyncope, hypotension, tachycardia, tachypnea, renal insufficiency, elevated white count. On hospital day #2 she was diagnosed with acute diverticulitis. Will probably be discharged tomorrow.
Age: 67.0
Sex: F
Vaccine: HEP
Symptoms: Tachypnoea, Troponin I, Vomiting, White blood cell count increased
Clinical narrative: At routine visit pt was given 1st injection of Hep B vaccine due to history of diabetes. One hour after receiving injection she went to the hospital ED and was admitted to the MICU with nausea, vomiting, epigastric pain, presyncope, hypotension, tachycardia, tachypnea, renal insufficiency, elevated white count. On hospital day #2 she was diagnosed with acute diverticulitis. Will probably be discharged tomorrow.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Blood test, Chest pain, Computerised tomogram, Dizziness, Electrocardiogram
Clinical narrative: Collapsed on the living room floor @ 4 am and wasn't able to move. Had a throbbing headache, weakness in legs, dizzy spells and chest pains. Waited to speak w/doctor and got an emergency apt and followed up w/a neurologist the same day in Feb 2012. On 4/2/2012, fainted due to migraine and was unconscious for close to 15 minutes and was rushed to the hospital, which later became the 1st of 24 hospital visits for 32 different symptoms.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Electrocardiogram ambulatory, Electroencephalogram, Headache, Loss of consciousness, Lumbar puncture
Clinical narrative: Collapsed on the living room floor @ 4 am and wasn't able to move. Had a throbbing headache, weakness in legs, dizzy spells and chest pains. Waited to speak w/doctor and got an emergency apt and followed up w/a neurologist the same day in Feb 2012. On 4/2/2012, fainted due to migraine and was unconscious for close to 15 minutes and was rushed to the hospital, which later became the 1st of 24 hospital visits for 32 different symptoms.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Migraine, Mobility decreased, Muscular weakness, Nuclear magnetic resonance imaging, Syncope
Clinical narrative: Collapsed on the living room floor @ 4 am and wasn't able to move. Had a throbbing headache, weakness in legs, dizzy spells and chest pains. Waited to speak w/doctor and got an emergency apt and followed up w/a neurologist the same day in Feb 2012. On 4/2/2012, fainted due to migraine and was unconscious for close to 15 minutes and was rushed to the hospital, which later became the 1st of 24 hospital visits for 32 different symptoms.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Tilt table test, Ultrasound abdomen, X-ray
Clinical narrative: Collapsed on the living room floor @ 4 am and wasn't able to move. Had a throbbing headache, weakness in legs, dizzy spells and chest pains. Waited to speak w/doctor and got an emergency apt and followed up w/a neurologist the same day in Feb 2012. On 4/2/2012, fainted due to migraine and was unconscious for close to 15 minutes and was rushed to the hospital, which later became the 1st of 24 hospital visits for 32 different symptoms.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site vesicles
Clinical narrative: Swelling with  hard red tissue around injection site with a large red halo from elbow to shoulder cuff, called the doctor, was put on voicemail. Awaiting call I got in on the 26 August. Was examined by nurse and she witnessed blistering around the initial injection site.  Was given Acyclovir 800 mg to take 5 times a day for possibly 10 days in case it was stubborn. Gradually healed by the 30th of August.
Age: 12.0
Sex: M
Vaccine: FLUN4, MNQ, TDAP
Symptoms: Hypoaesthesia, Injection site pain, Local swelling
Clinical narrative: Pain at site following administration. Noted increased pain and swelling 36 hours later, swelling in arm and on hand, hand feels numb but exam for sharp/dull was normal.
Age: 47.0
Sex: M
Vaccine: FLU3
Symptoms: Abdominal discomfort, Lacrimation increased, Ocular hyperaemia, Pruritus, Throat tightness
Clinical narrative: Itchy ear, throat tightening, red watery eyes, upset stomach, BENADRYL given at 5:50 pm shot given at 3:15 pm. 30 minutes later taken to hospital - overnight stay - still in hospital as of 9/3/13 9:30 AM.
Sex: U
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Hypoaesthesia
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with ZOSTAVAX. Indication, lot number, expiry date, route of administration and anatomical location were not reported. On an unknown date after the vaccination the patient experienced numbness (hospitalization). The outcome of numbness is unknown. The reporting pharmacist did not provide a causality statement. Additional information has been requested.
Sex: U
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Hypoaesthesia, Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with ZOSTAVAX. Indication, lot number, expiry date, route of administration and anatomical location were not reported. On an unknown date after the vaccination the patient experienced numbness (hospitalization). The outcome of numbness is unknown. The reporting pharmacist did not provide a causality statement. Additional information has been requested.