chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema
Clinical narrative: This spontaneous report as received from a 65 year old female patient with blood pressure and cholesterol, reporting on herself. The patient had no known drug reactions/allergies. On 06-MAY-2014, the patient received one single shot of ZOSTAVAX, SC, (lot # and expiration date were not provided). Co-suspect therapy was not provided. Concomitant therapies included aspirin, unspecified blood pressure and cholesterol medications (therapies not provided). It was reported that on 06-MAY-2014, after receiving ZOSTAVAX, the patient developed a large red mark about the size of a quarter that did not itch on her arm. The patient also reported it took about a month for the mark to completely go away. The patient did not receive any treatment for the event. The patient sought unspecified medical attention. At the time of the report the patient had recovered. The relatedness between the event and suspect therapy was not provided. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: TYP
Symptoms: Abdominal pain upper
Clinical narrative: Stomach cramps.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site urticaria
Clinical narrative: 93kg 63 yo M was given varicella zoster vaccine 0.65ml SC in right deltoid on 6/20 @ 1025.  Within 5 minutes before leaving clinic, pt complained of itching and buring at injection site.  Onset of symptoms within 5 minutes of injection.  Redness and hives noted to injection site.  No other symptoms.  BP WNL.  MD notified.  MD provided prescription for 25mg diphenhydramine PO q6hprn itching.
Age: 34.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Pain, Rash
Clinical narrative: Pt stated she received vaccine in hospital after childbirth. Next day c/o painful, and rash around her abdomen. Raised hard and redness at site approx. 3 inch diam.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site mass, Injection site pain, Injection site rash
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 63 year old female patient. Medical history was not reported. On 05-JUN-2014 the patient was vaccinated with ZOSTAVAX injection, 0.65 ml, subcutaneous, lot number and strength were not reported. Concomitant therapy was not reported. The pharmacist informed that on 07-JUN-2014, the patient experienced a lump at the injection site, after receiving ZOSTAVAX. The pharmacist described the injection site reaction as a lump that was rashy and bumpy, also stated that it felt like she bumped herself at the injection site. The patient did not receive treatment for the adverse events and she saw the pharmacist as a sought medical attention. The outcome of the events was unknown. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to roughly 20 unspecified patients of unknown age. On an unknown date, roughly 20 unspecified were vaccinated with VARIVAX (Merck) injection, (strength, dose, frequency, route of administration and indication were not provided) that reached 18.5 F for 10 hours and 44 minutes. This range was outside of storage conditions in product insert; however, in house stability data can support those conditions mentioned above that the VARIVAX (Merck) was exposed to. No concomitant medication was reported. No adverse effects reported. No product quality complaint (PQC) was reported. The outcome of events was unknown. No further adverse event information was available. Follow up information has been received from a nurse concerning VARIVAX (Merck) temperature excursion and one patient (patient ID #112300) of unspecified age and gender who was vaccinated with VARIVAX (Merck) (injection, strength, dose, frequency, route of administration and indication were not provided) (lot # J012211, exp date: 28-SEP-2015) that reached 18.5 F for 10 hours and 44 minutes. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age. The nurse reported that the unspecified patient received the 1st dose of MMR II (lot number, dose, route and strength were not reported) on 09-JUN-2014 and the 2nd dose of MMR II on 18-JUN-2014; the spacing between the vaccine doses was less than the recommended 28 day interval. No adverse effects reported. The outcome and action taken were not provided. It was not specified if the patient sought any medical attention. Additional information is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to roughly 20 unspecified patients of unknown age. On an unknown date, roughly 20 unspecified were vaccinated with VARIVAX (Merck) Injection, (strength, dose, frequency, route of administration and indication were not provided) that reached 18.5 F for 10 hours and 44 minutes. This range was outside of storage conditions in product insert; however, in house stability data can support those conditions mentioned above that the VARIVAX (Merck) was exposed to. No concomitant medication was reported. No adverse effects reported. No product quality complaint (PQC) was reported. The outcome of events was unknown. No further adverse event information was available. Follow up information (after previous telephone attempt to obtain follow up information which has been unsuccessful) has been received from a nurse concerning VARIVAX (Merck) temperature excursion and one patient of unspecified age and gender who was vaccinated with VARIVAX (Merck) (injection, strength, dose, frequency, route of administration and indication were not provided) (lot # J009990, exp date: 12-AUG-2015) that reached 18.5 F for 10 hours and 44 minutes. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified number of unspecified patients. Concomitant medication and pertinent medical history were not provided. On an unknown date an unspecified number of unspecified patients were vaccinated with unspecified number of doses of ROTATEQ (lot #, dose, route and indication were not provided), which were exposed to temperature excursions outside of the recommended storage range. No adverse effect reported. Additional information has been requested.
Age: 22.0
Sex: M
Vaccine: PPV
Symptoms: Pneumococcal infection
Clinical narrative: This spontaneous report was received from a physician refers to an approximately 22 year old male patient. The patient's medical history included sickle cell disease. On an unknown date the patient was vaccinated with PNEUMOVAX23 vial, lot number, route, strength and dosage were not reported. Concomitant therapy was not reported. The reporter informed that on an unknown date (also reported as at unspecified time in the past) the patient developed a form of pneumococcal disease (type unspecified) about 7 months after received a dose of PNEUMOVAX23. The outcome of the event was unknown. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to roughly 20 unspecified patients of unknown age. On an unknown date, roughly 20 unspecified were vaccinated with VARIVAX (Merck) Injection, (strength, dose, frequency, route of administration and indication were not provided) that reached 18.5 F for 10 hours and 44 minutes. This range was outside of storage conditions in product insert; however, in house stability data can support those conditions mentioned above that the VARIVAX (Merck) was exposed to. No concomitant medication was reported. No adverse effects reported. No product quality complaint (PQC) was reported. The outcome of events was unknown. No further adverse event information was available. Follow up information (after previous telephone attempt to obtain follow up information which has been unsuccessful) has been received from a nurse concerning VARIVAX (Merck) temperature excursion and one patient of unspecified age and gender who was vaccinated with VARIVAX (Merck) (injection, strength, dose, frequency, route of administration and indication were not provided) (lot # J012211, exp date: 28-SEP-2015) that reached 18.5 F for 10 hours and 44 minutes. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to roughly 20 unspecified patients of unknown age. On an unknown date, roughly 20 unspecified patients were vaccinated with (Oka/Merck) VARIVAX (injection, strength, dose, frequency, route of administration and indication were not provided) that reached 18.5 for 10 hours and 44 minutes. This range was outside of storage conditions in product insert; however, the reporter stated that their in house stability data could suppose those conditions mentioned above that the (Oka/Merck) VARIVAX was exposed to. No concomitant medication was reported. No adverse effects reported. No product quality complaint (PQC) was reported. The outcome of events was unknown. No further adverse information was available.   Follow up information (after previous telephone attempt to obtain follow-up information which has been unsuccessful) has been received from nurse concerning (Oka/Merck) VARIVAX temperature excursion and one patient (patient ID#120680) of unspecified age and gender who was vaccinated with (Oka/Merck) VARIVAX (injection, strength, dose, frequency, route of administration and indication were not provided) (lot # J012817, exp date: 10-OCT-2015) that reached 18.5 F for 10 hours and 44 minutes. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from an office manager and nurse practitioner, regarding multiple unspecified patients (age and gender not provided). Patient's pertinent medical history, drug reactions/allergies were not provided. On an unknown date, multiple unspecified patients received doses of PROQUAD (route, lot number and expiration date were not provided) that were stored improperly. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from an office manager and nurse practitioner, regarding multiple unspecified patients (age and gender not provided). Patient's pertinent medical history, drug reactions/allergies were not provided. On an unknown date, multiple unspecified patients received doses of VARIVAX (Merck) (route, lot number and expiration date were not provided) that were stored improperly. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to roughly 20 unspecified patients of unknown age. On an unknown date, roughly 20 unspecified patients were vaccinated with (Oka/Merck) VARIVAX (injection, strength, dose, frequency, route of administration and indication were not provided) that reached 18.5 for 10 hours and 44 minutes. This range was outside of storage conditions in product insert; however, the reporter stated that their in house stability data could suppose those conditions mentioned above that the (Oka/Merck) VARIVAX was exposed to. No concomitant medication was reported. No adverse effects reported. No product quality complaint (PQC) was reported. The outcome of events was unknown. No further adverse information was available.   Follow up information (after previous telephone attempt to obtain follow-up information which has been unsuccessful) has been received from nurse concerning (Oka/Merck) VARIVAX temperature excursion and one patient (patient ID#152710) of unspecified age and gender who was vaccinated with (Oka/Merck) VARIVAX (injection, strength, dose, frequency, route of administration and indication were not provided) (lot # J012817, exp date: 10-OCT-2015) that reached 18.5 F for 10 hours and 44 minutes. This is one of several reports received from the same source. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Head injury, Laboratory test normal, Loss of consciousness, Pyrexia
Clinical narrative: Pt had slight fever overnight. Pt woke up next morning within 45 min. yet went to kitchen passed out. Hit her head on tile floor, regained consciousness her fiance called 911 and went to hospital. Pt had diff tests. Needed to check for any blood clot.
Age: 0.75
Sex: M
Vaccine: DTAPHEPBIP, PNC13
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: None. Called parent and pt is doing well. Received vaccines in error - not needed at this visit. Vaccines already given at previous visit.
Age: 2.0
Sex: M
Vaccine: DTAP
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 15.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Musculoskeletal stiffness, Neck pain, Pain in extremity, Vaccination site pain
Clinical narrative: Stiff neck and sore arm. Severe neck pain and pain at vaccine sites.
Age: 14.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Petechiae, Urticaria
Clinical narrative: Woke up with generalized hive-like rash on trunk. During the day, hives spread to arms and neck with petechiae. Was treated with oral antihistamines and prednisone.
Age: 14.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Urticaria
Clinical narrative: Woke up with generalized hive-like rash on trunk. During the day, hives spread to arms and neck with petechiae. Was treated with oral antihistamines and prednisone.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Injection site induration, Injection site mass, Injection site pain, Injection site pruritus
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 64 year old female patient with asthma, hypothyroidism, vitamin D deficiency, osteoarthritis. The patient had drug reactions/allergies to adhesives, AUGMENTIN (reported as "AUGMENT"), doxycycline, morphine, Sulfa, shellfish and cefuroxime. On 05-JUN-2014 the patient was vaccinated with PNEUMOVAX 23 (injection, 0.5ml one dose, lot # J008799, expiration date 15-APR-2016) intramuscularly. Concomitant therapies included QVAR, RHEUMATREX (reported as "RHEUMATRIX DOSE PACK"), omeprazole and PREMPRO. On 05-JUN-2014 the patient experienced itchiness, soreness and a hard lump at the injection site area after receiving PNEUMOVAX 23. The patient contacted medical office for medical attention and was treated with BENADRYL, ADVIL and a cool compress. No lab diagnostics studies were performed. The outcome of events were unknown. Causality assessment was not provided by the reporter. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 32.0
Sex: M
Vaccine: TDAP
Symptoms: Chills, Fatigue, Headache, Hyperhidrosis, Injection site pain
Clinical narrative: Total body aches, headaches, fever, chills, profuse sweating, exhaustion, lethargy, localized swelling around injection site,pain at injection site, improving by 06/20/2014
Age: 32.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site swelling, Lethargy, Pain, Pyrexia
Clinical narrative: Total body aches, headaches, fever, chills, profuse sweating, exhaustion, lethargy, localized swelling around injection site,pain at injection site, improving by 06/20/2014
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Body temperature increased, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: The evening of 6/18/14 the patients right upper lateral arm began to show redness, warmth , and swelling. Patient brought to clinic by father at 0800 6/19/14. Vitals WNL, with exception of 99.3 oral temperature. Patient examined by FNP, Benadryl 25mg every 6 hours ordered and follow up in clinic in am. Patient returned to clinic 6/20/14 No erythema or warmth noted, with decrease in swelling. Pt seen by FNP, instructed to continue Benadryl for 2 additional days and then discontinue.
Age: 29.0
Sex: F
Vaccine: MEN
Symptoms: Dizziness, Headache, Middle insomnia, Muscular weakness, Pain
Clinical narrative: I started feeling dizzy early this morning & my body ached. I kept waking up every hour starting around 4:30 AM. My legs still feel weak & my head hurts. I called my doctor's office & was told to come in for treatment but how can I travel if I can barely stand? The woman on the phone said the doctor can't treat me unless she can see me in person & can't take my word on the symptoms.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus
Clinical narrative: Pt states: Arm became blood-red. Neck became itchy. Resolved over next few days.
Age: 3.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Irritability, Pain
Clinical narrative: RIGHT LEG BEGAN TO SWELL AND BECOME VERY TENDER AND RED EVENTUALLY SWELLING TO 10 INCHES. PT WAS VERY FUSSY, IRRITABLE AND IN SIGNIF.PAIN. THIS SIZE OF SWELLING PERSISTED FOR 10 DAYS
Age: 18.0
Sex: M
Vaccine: HPV4
Symptoms: Fall, Syncope
Clinical narrative: SYNCOPE. FELL TO FLOOR (WAS SEATED)
Age: 32.0
Sex: M
Vaccine: HEPA, TDAP
Symptoms: Incorrect dose administered
Clinical narrative: None, client was given pediatric dose of Hepatitis A
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: redness around the site of the injection with heat in it and itching.  The redness was about the size of a baseball in area.  Drew around the area to make sure did not keep getting bigger.  Told her to use ice for the heat and she already takes Aleve every morning but also to take Benadryl for the itching.
Age: 12.0
Sex: F
Vaccine: VARCEL
Symptoms: Local swelling, Skin warm
Clinical narrative: 50 cent piece size swelling and warmth on posterior upper arm
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Dizziness, Fall, Head injury
Clinical narrative: Given vaccines. Told to sit for several minutes. Maybe 5 minutes later the mother and patient came to front desk to schedule next HPV appt. Pt then said she thought she was going to faint and went to the floor, bumping her head slightly against the wall of the appt desk. Was able to answer questions immediately. Pt was placed in shock position, ice pack to base of skull. Dr at pt side. Kept in shock position for several minutes then to seated position for another 5 minutes then released home in care of mother.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood pressure increased, Dizziness, Dysphagia, Dyspnoea
Clinical narrative: PATIENT FELT LIGHTHEADED AND BP WAS ELEVATED.  THE PHARMACIST INSTRUCTED THE PATIENT TO PUT HER HEAD BETWEEN HER KNEES WHICH SHE DID.  BP WAS 174/90 WITH A PULSE OF 74 IN THE LEFT ARM.  THE PATIENT DRANK SOME WATER AND A BP CHECK FIVE MINUTES LATER WAS 150/80 IN THE RIGHT ARM.  THE PATIENT WAS SITTING UPRIGHT & CONVERSING IN A NORMAL MANNER.  A THIRD BP CHECK WAS 120/90 & THE PATIENT DECIDED TO GO HOME.  THE PHARMACIST WALKED HER TO HER CAR & SHE STATED SHE FELT WELL ENOUGH TO DRIVE.  30 MIN LATER THE PT RETURNED TO THE PHARMACY & SAID SHE WAS HAVING TROUBLE SWALLOWING & HER BP WAS ELEVATED.  THE PHARMACIST DID NOT OBSERVE ANY TROUBLE WITH THE PATIENT'S BREATHING & THE PT WAS ABLE TO DRINK WATER.  THE PHARMACIST RECOMMENDED THE PT CALL HER PHYSICIAN, BUT HE WAS NOT IN THE OFFICE ON FRIDAY.  THE PHARMACIST THEN RECOMMENDED THE PT GO TO THE HOSPITAL IF SHE WAS HAVING DIFFICULTY BREATHING (WHICH THE PT SAID SHE WAS ALTHOUGH SHE DID NOT APPEAR TO BE).  THE INJECTION SITE LOOKED NORMAL, NO UNUSUAL REDNESS OR SWELLING.  THE PT STATED SHE WOULD GO HOME & TAKE BENADRYL AND AGAIN THE PHARMACIST WALKED HER TO HER CAR, THE PT WALKED WITH NO DIFFICULTY OR APPARENT SOB.  THE PHARMACIST CALLED THE PATIENT 20 MINUTES LATER-THE PATIENT SAID SHE HAD TAKEN BENADRYL AND USED HER COMBIVENT INHALER (THE PT HAD NOT MENTIONED THAT SHE USED MEDICATIONS FOR COPD/ASTHMA) & THAT SHE FELT BETTER.  A FOLLOW UP PHONE CALL AT 5:44 PM WAS NOT ANSWERED.
Age: 0.54
Sex: F
Vaccine: DTPHIB, HEP, PNC13, RV5
Symptoms: Crying, Decreased appetite, Diarrhoea, Flatulence, Irritability
Clinical narrative: GASSY, FUSSY, CRYING, DIARRHEA, VOMITING, POOR EATING.  LASTING ABOUT 2 WEEKS.
Age: 0.54
Sex: F
Vaccine: DTPHIB, HEP, PNC13, RV5
Symptoms: Vomiting
Clinical narrative: GASSY, FUSSY, CRYING, DIARRHEA, VOMITING, POOR EATING.  LASTING ABOUT 2 WEEKS.
Age: 41.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Redness and slight swelling along with warmth to touch
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Injection site induration, Injection site mass
Clinical narrative: A few days after the vaccination, I noticed a small hard lump in her left thigh at the site of the injection.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site reaction, Injection site vesicles, Scab
Clinical narrative: LEFT Shoulder where kinrix vaccine given erythema, induration vessicles 10.5cm X 11cm.On 6/20 only few crusts from vessicles, otherwise completely resolved.
Age: 1.05
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Injection site erythema, Injection site swelling, Skin warm
Clinical narrative: mom noticed redness and mild swelling at injection site. no warmt at site. mom states pt was warm, tmax unk, no thermometer, but mom gave acetaminophen, relieved. mom states felt swelling "like a bug bite" at injection site. mom states swelling has decreased from initial onset.
Sex: U
Vaccine: RVX
Symptoms: Convulsion
Clinical narrative: Case reference number B1005904A was reported in a literature article and refers to a subject of undetermined gender who was born between 2004 and 2008 and was diagnosed with a seizure between 93 and 730 days of life. This diagnosis occurred within seven days of receiving an unspecified rotavirus vaccination on an undetermined date (manufacturer, batch number, route and dose unknown). The subject received this first vaccination on a delayed schedule as it should have been given at two months of age. No further information regarding the subject's medical, family history or concurrent medication has been provided. A subject of undetermined gender and born between 2004 and 2008 was diagnosed with a seizure either in an emergency department or in a hospital between 93 and 730 days of life. This diagnosis occurred within seven days of receiving an unspecified rotavirus vaccination on an undetermined date (manufacturer, batch number, route and dose unknown). No further information has been provided regarding any symptoms displayed by the subject or any clinical examinations or investigations performed; but the authors report that the event was classified using the ICD-9CM codes for "seizure". Diagnosis was seizure. Treatment and outcome of the event were unspecified. Author's conclusion: "For children who received their first vaccination on a delayed schedule between 93 and 730 days of life, the incident rate ratios for seizures were generally elevated but not significant." This was one of 3 cases reported in the same article.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Apnoea, Chest X-ray normal, Electrocardiogram normal, Full blood count normal, Hypopnoea
Clinical narrative: Pt developed violent vomiting 3 hrs after vaccination, followed by fever, going limp, pale and dusky with shallow respirations and apnea, requiring stimulation, O2.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Hypotonia, Metabolic function test, Pallor, Pyrexia, Skin discolouration
Clinical narrative: Pt developed violent vomiting 3 hrs after vaccination, followed by fever, going limp, pale and dusky with shallow respirations and apnea, requiring stimulation, O2.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Vomiting projectile
Clinical narrative: Pt developed violent vomiting 3 hrs after vaccination, followed by fever, going limp, pale and dusky with shallow respirations and apnea, requiring stimulation, O2.
Age: 2.0
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Constipation, Dyskinesia, Injection site cellulitis, Injection site erythema, Injection site induration
Clinical narrative: This case was reported by a consumer (subject's mother) and described the occurrence of injection site cellulitis in a 25-month-old male subject who was vaccinated with PEDIARIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. The subject's medical history included ear infection treated with antibiotics and rash due to antibiotics. Concurrent vaccination included DTPA vaccine (non-GSK, Sanofi Pasteur) given on an unspecified date when he was 22 months old. On 22 April 2014, the subject received unspecified dose of PEDIARIX (unknown route, left thigh). On 23 April 2014, 1 day after vaccination with PEDIARIX, the subject experienced jerking, twitching and tremor in sleep. On 24 April 2014, the subject experienced hardness and redness at injection site and severe constipation. The child was breast fed on demand and had never experienced constipation before. The injection site reaction was diagnosed as cellulitis. This case was assessed as medically serious by GSK. The subject was treated with Magnesium and constipation improved. At the time of reporting, the injection site cellulitis was resolved but the shaking, twitching and jerking were unresolved. The subject was referred to a neurologist.
Age: 2.0
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Muscle twitching, Tremor
Clinical narrative: This case was reported by a consumer (subject's mother) and described the occurrence of injection site cellulitis in a 25-month-old male subject who was vaccinated with PEDIARIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. The subject's medical history included ear infection treated with antibiotics and rash due to antibiotics. Concurrent vaccination included DTPA vaccine (non-GSK, Sanofi Pasteur) given on an unspecified date when he was 22 months old. On 22 April 2014, the subject received unspecified dose of PEDIARIX (unknown route, left thigh). On 23 April 2014, 1 day after vaccination with PEDIARIX, the subject experienced jerking, twitching and tremor in sleep. On 24 April 2014, the subject experienced hardness and redness at injection site and severe constipation. The child was breast fed on demand and had never experienced constipation before. The injection site reaction was diagnosed as cellulitis. This case was assessed as medically serious by GSK. The subject was treated with Magnesium and constipation improved. At the time of reporting, the injection site cellulitis was resolved but the shaking, twitching and jerking were unresolved. The subject was referred to a neurologist.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified patients of unknown age and gender. On an unknown date 2 doses of M-M-R II (dose, route of administration, lot # and expiration date were not provided) all of which reached the temperature outside the product information, have been administered to unspecified patients. The temperature was supported. No adverse effects were reported. This is one of several reports from the same source (MARRS# 1406USA008283, 1406USA008285, 1406USA007026). Additional information has been requested.
Age: 58.0
Sex: F
Vaccine: TDAP
Symptoms: Rash, Swollen tongue
Clinical narrative: Tdap (ADACEL) given on 6/12/14. 4 hours later patient experienced rash and swollen tongue. Issue resolved with 1 dose of BENADRYL, patient took herself.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Pyrexia
Clinical narrative: Pt had a temperature of 102 degrees after receiving multiple vaccines.
Age: 38.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Chills, Nausea, Pain, Pyrexia
Clinical narrative: Pt called back and stated he chose to have both injections in the RD. Pt then called back and stated he was having chills, achy and one episode of nausea. Pt did not call back for 2 day with this information. Pt was advised to use TYLENOL for fever and if worsening needs visit.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown demographics. The patient's current conditions or medical history were not reported. On an unknown date, the patient was vaccinated with the first dose RECOMBIVAX HB injection 2.5/0.5 8 (units not reported) (dose, route, lot number and expiration date not reported) and would like to receive a second dose outside of the recommended dosing interval. No adverse symptoms reported. Additional information has been requested.
Sex: U
Vaccine: HEPA, HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a newborn patient of unknown age and gender. On an unknown date the patient was vaccinated with the first dose of VAQTA (dose, route and lot number were not reported). Concomitant medications were not reported. No adverse symptoms reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Medical history and concurrent conditions were not reported. In March 2014, the patient was vaccinated with first dose of VARIVAX 0.5 ml, subcutaneous (strength, lot number and expiration date were not reported). On 11-JUN-2014 the patient was vaccinated with second dose of VARIVAX (dose, strength, frequency, lot number and expiration date were not reported) at a local pharmacy. However, patient went to another pharmacy and pharmacist did not realize that patient had received a second dose of (Oka/Merck) VARIVAX and administered another dose (third dose) of VARIVAX (dose, strength, frequency, lot number and expiration date were not reported) on 13-JUN-2014. No adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Unevaluable event
Clinical narrative: This spontaneous report as received from nurse refers to a patient of unknown age. On 26-MAY-2014, the patient was inadvertently administered with PROQUAD (lot #, expiry date unknown) injection, subcutaneous. There was not product quality complaint. The outcome of the event was unknown. Additional information is not expected.
Age: 12.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Urticaria
Clinical narrative: 12cm x 7cm localized histaminic response, no sign of infection, no other adverse response noted, no hives.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Erythema, Hypersensitivity, Pruritus, Skin warm
Clinical narrative: (R) arm redness, warm, itching. Patient was/received BENADRYL 50mg IM on (L) thigh.
Age: 2.0
Sex: F
Vaccine: HEPA, HIBV, PNC13, TDAP
Symptoms: Wrong drug administered
Clinical narrative: The patient was given the wrong vaccine. She was due for DTaP, but she received Tdap, by accident. Provider spoke with CDC, who verified that this dose is considered "valid".
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Discomfort, Musculoskeletal pain, Pain in extremity
Clinical narrative: Pt. reports arm soreness, discomfort and weakness. Symptoms started day of injection and are still bothersome as of 6/20/14 (8 mon). Pain from shoulder to about 5 inches below in triceps region.
Age: 16.0
Sex: F
Vaccine: HEPA, MNQ
Symptoms: Erythema, Rash, Skin warm
Clinical narrative: Rt deltoid with no swelling, mildly warm to touch, erythema shaped in a heart appearance with 3 in. spread of erythema.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Dyspnoea, Swelling face
Clinical narrative: 4 yr old imm. adm. - KINRIX/MMR/Varicella. Within 5 min. pt. noted to have difficulty breathing. Face swelling. O2 sat 93%. Breathing Tx with O2 given. EPI given x2. Transported to emergency room.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Change of bowel habit, Chills, Pain in extremity, Pyrexia
Clinical narrative: Patient presented with left arm pain (vaccine administered in left deltoid), fever, and chills.
Age: 4.0
Sex: M
Vaccine: IPV, MMR, VARCEL
Symptoms: Cough, Eczema, Pruritus generalised, Pyrexia, Rash erythematous
Clinical narrative: Severe red rash on face, neck, back, stomach and arms for duration of 10 days. Fever of 99.0 for duration of 1 day. Consulted primary pediatrician around 6/2/2014, and was advised to monitor rash, and if not completely gone, schedule an appointment. Redness llessened, but rash still present until 6/18/2014, scheduled appointment. Doctor diagnosed "eczema." On 6/19/2014, rash returned in more severe fashion with, dry cough, rapid nighttime breathing, extreme redness, moderate itching, and from head to toe. Another scheduled appointment on 6/20/2014 doctor diagnosed with post vaccination rash. No medication prescribed. Was suggested to administer benadryl, but has not been effective.
Age: 4.0
Sex: M
Vaccine: IPV, MMR, VARCEL
Symptoms: Rash generalised, Respiratory rate increased, Streptococcus test negative
Clinical narrative: Severe red rash on face, neck, back, stomach and arms for duration of 10 days. Fever of 99.0 for duration of 1 day. Consulted primary pediatrician around 6/2/2014, and was advised to monitor rash, and if not completely gone, schedule an appointment. Redness llessened, but rash still present until 6/18/2014, scheduled appointment. Doctor diagnosed "eczema." On 6/19/2014, rash returned in more severe fashion with, dry cough, rapid nighttime breathing, extreme redness, moderate itching, and from head to toe. Another scheduled appointment on 6/20/2014 doctor diagnosed with post vaccination rash. No medication prescribed. Was suggested to administer benadryl, but has not been effective.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Activities of daily living impaired, Injected limb mobility decreased, Injection site bruising, Injection site erythema, Injection site pain
Clinical narrative: Moderate to severe localized pain in area of injection, bruising, swelling, redness. Inability to raise arm or use arm to lift normal household items (e.g., hairdryer).
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site swelling
Clinical narrative: Moderate to severe localized pain in area of injection, bruising, swelling, redness. Inability to raise arm or use arm to lift normal household items (e.g., hairdryer).
Age: 15.0
Sex: F
Vaccine: HPV2
Symptoms: Blindness unilateral, Eye pain, Headache, Lumbar puncture, Nuclear magnetic resonance imaging
Clinical narrative: Patient began severe headache with rght eye pain which lasted for three weeks and was misdiagnosed as  a sinus infection and migraine. Patient lost complete vision in right eye and was diagnosed with optic neuritis on 5/21/2014 and hospitalized.
Age: 15.0
Sex: F
Vaccine: HPV2
Symptoms: Optic neuritis
Clinical narrative: Patient began severe headache with rght eye pain which lasted for three weeks and was misdiagnosed as  a sinus infection and migraine. Patient lost complete vision in right eye and was diagnosed with optic neuritis on 5/21/2014 and hospitalized.
Age: 24.0
Sex: F
Vaccine: YF
Symptoms: Hyperhidrosis, Pallor
Clinical narrative: Pt became pale and diaphoretic post administration. Pt remained conscious. Pt placed in reclining position with feet elevated and cool compress applied to forehead and back of neck. Pt vs taken and pt give water to drink. Pt recovered and denied chest pain, no s/sx resp.Distress. Pt denied feeling dizzy after interventions. No swelling no urticaria.
Age: 15.0
Sex: F
Vaccine: FLU4, HPV4
Symptoms: Computerised tomogram head normal, Demyelination, Muscular weakness, Nuclear magnetic resonance imaging brain abnormal, Nuclear magnetic resonance imaging brain normal
Clinical narrative: Weakness of upper and lower extremities, blurry vision.
Age: 15.0
Sex: F
Vaccine: FLU4, HPV4
Symptoms: Vision blurred, White matter lesion
Clinical narrative: Weakness of upper and lower extremities, blurry vision.
Age: 20.0
Sex: M
Vaccine: FLU3, HPV4, MNQ, VARCEL, FLU3, HPV4, MNQ, VARCEL
Symptoms: Condition aggravated, Seizure like phenomena
Clinical narrative: Mother stated patient had an increase in seizure activity after administration (pt has hx of seizures) mother just notified clinic today (6/21/14).
Age: 20.0
Sex: M
Vaccine: FLU3, HPV4, MNQ, VARCEL, FLU3, HPV4, MNQ, VARCEL
Symptoms: Condition aggravated, Convulsion
Clinical narrative: Mother stated patient had an increase in seizure activity after administration (pt has hx of seizures) mother just notified clinic today (6/21/14).
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus, Rash
Clinical narrative: Rash on buttocks to back of knee on left leg, itching; occurred next day after ZOSTAVAX.
Age: 29.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous prospective pregnancy report as received from a physician refers to a 29 year old female patient with no Pertinent Medical History and no Drug Reactions/Allergies. The physician reported that the patient was administered an additional dose of GARDASIL (lot # J011272, exp date: 21-APR-2016) on 13-MAY-2014 in the office. The representative also reported that the patient was declared to be 29 weeks pregnant on 13-MAY-2014." The physician reported that the patient had received the third dose completing the series of GARDASIL on 13-APR-2010. The exact date the initial dose of GARDASIL was administered is unknown. The physician reported to the representative that, "the patient was supposed to receive an (unspecified) vaccine but there was a mix up and the patient received GARDASIL instead." The patient was given no treatment for AE. It was estimated the patient became pregnant with LMP of 22-OCT-2013 and EDD of 29-JUL-2014. Initial exposure to GARDASIL was at 29 week(s). The pregnancy outcome was outcome pending. Additional information has been requested.
Age: 29.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Exposure during pregnancy, Incorrect dose administered, Wrong drug administered
Clinical narrative: This spontaneous prospective pregnancy report as received from a physician refers to a 29 year old female patient with no Pertinent Medical History and no Drug Reactions/Allergies. The physician reported that the patient was administered an additional dose of GARDASIL (lot # J011272, exp date: 21-APR-2016) on 13-MAY-2014 in the office. The representative also reported that the patient was declared to be 29 weeks pregnant on 13-MAY-2014." The physician reported that the patient had received the third dose completing the series of GARDASIL on 13-APR-2010. The exact date the initial dose of GARDASIL was administered is unknown. The physician reported to the representative that, "the patient was supposed to receive an (unspecified) vaccine but there was a mix up and the patient received GARDASIL instead." The patient was given no treatment for AE. It was estimated the patient became pregnant with LMP of 22-OCT-2013 and EDD of 29-JUL-2014. Initial exposure to GARDASIL was at 29 week(s). The pregnancy outcome was outcome pending. Additional information has been requested.
Age: 27.0
Sex: F
Vaccine: MMR
Symptoms: Urticaria
Clinical narrative: Hives all over face, arms, torso and upper legs.Started on torso and moved up and out. Received a steroid shot at office and have taken Benadryl.
Age: 46.0
Sex: M
Vaccine: DPP
Symptoms: Injection site erythema, Injection site pain, Pain, Pyrexia
Clinical narrative: Body aches, fever at 99.9.  Used ibuprofen. Redness spreading where injection occurred. Pain to the touch.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Hypersensitivity, Local swelling, Pruritus, Urticaria
Clinical narrative: With 2 minutes the nurse recognized signs of allergic reaction: localized redness swelling, hives, itching. She applied an ice pack to the swelling and retrieved a doctor who immediately treated with Benadryl and watched for signs of respiratory distress.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Local swelling, Pyrexia, Rheumatoid arthritis
Clinical narrative: Initially it was swelling (entire arm between shoulder and elbow). Lasted for about a week. Fever, fatigue.  Several weeks later I developed RA symptoms.
Age: 57.0
Sex: F
Vaccine: PPV
Symptoms: Myalgia, Pyrexia
Clinical narrative: Fever onset within 2-3 hours of shot. Pain in deltoid muscle that night and continues. Saturday 6/21 rash (size of quarter) began then intensified by Sunday 6/22 - getting bigger surface area.
Age: 4.0
Sex: F
Vaccine: MMR
Symptoms: Rubella antibody negative, Viral test negative
Clinical narrative: This spontaneous report as receive from a healthcare worker refers to a 20 year old female patient with no pertinent medical history or drug reactions/allergies. On 19-OCT-1995 and 27-AUG-1998 the patient was vaccinated with first and second doses of M-M-R II (lot#, expiration date, dose, route, indication not reported). There was no concomitant medication. On 09-MAY-2014, the patient experienced the patient had titers drawn and results of the titers showed that the patient was not immune to rubella. There was no treatment given for the event. The patient did not seek medical attention. The outcome of the patient the event was unknown. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Antibody test negative
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age. The physician reported that the patient had been vaccinated with 2 doses of VARIVAX (Merck) (lot# unknown, strength, dosage and route unknown). On an unknown date the patient had negative antibody titers to varicella. Lab test included antibody titers. The outcome of the event was unkonwn. The causality of the event and VARIVAX (Merck) was unknown. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to a patient of unknown age and unknown gender. The patient's pertinent medical history and drug reactions/allergies were not reported. On 05-JUN-2014 the patient was vaccinated wiht an expired dose of PNEUMOVAX 23, batch# H022062, Lot# 0506AE, expire date 28-FEB-2014, 0.5 ml, intramuscular. No adverse effecs were reported. Additional information has been requested.
Age: 33.0
Sex: U
Vaccine: FLU3, PPV, FLUC3, PPV
Symptoms: Cellulitis, Pyrexia, Skin warm
Clinical narrative: Case number PHHY2014US070803 is an initial spontaneous report received from the vaccine adverse event reporting system (reference number: 525671) on 09 Jun 2014 with a follow up report received from the Quality Assurance department (QA reference number: 305247) on 11 Jun 2014. This report refers to 33 years old patient of unknown gender. The patient's medical history and concomitant medications were not reported. The patient was vaccinated with FLUCELVAX (batch number: 006011A) intramuscularly on 06 Mar 2014. The patient was also vaccinated with PNEUMOVAX (other manufacturer, batch number: J004332) subcutaneously on 06 Mar 2014. It was reported that on an unknown date the patient experienced cellulitis, fever with a body temperature of greater than 39.4 degree C (103 F), warmth at the infection site. It was also reported that patient might have possible staph infections. The outcome of the events was reported as completely recovered by 12 Mar 2014. The health authority reported that the events as non-serious. However, MAH has upgraded the events. The causality of the events was not reported. The Quality Assurance department confirmed that the reported batch number: 006011A, belongs to FLUCELVAX and not FLUVIRIN. The investigation would be performed for FLUCELVAX and not for FLUVIRIN. Therefore the suspect vaccine was changed to FLUCELVAX (previously reported as FLUVIRIN). Follow up report was received from the Quality Assurance department (QA reference number: 305247) on 11 Jun 2014: The suspect vaccine and QA reference number were updated.
Age: 33.0
Sex: U
Vaccine: FLU3, PPV, FLUC3, PPV
Symptoms: Cellulitis, Injection site warmth, Pyrexia
Clinical narrative: Case number PHHY2014US070803 is an initial spontaneous report received from the vaccine adverse event reporting system (reference number: 525671) on 09 Jun 2014 with a follow up report received from the Quality Assurance department (QA reference number: 305247) on 11 Jun 2014. This report refers to 33 years old patient of unknown gender. The patient's medical history and concomitant medications were not reported. The patient was vaccinated with FLUCELVAX (batch number: 006011A) intramuscularly on 06 Mar 2014. The patient was also vaccinated with PNEUMOVAX (other manufacturer, batch number: J004332) subcutaneously on 06 Mar 2014. It was reported that on an unknown date the patient experienced cellulitis, fever with a body temperature of greater than 39.4 degree C (103 F), warmth at the infection site. It was also reported that patient might have possible staph infections. The outcome of the events was reported as completely recovered by 12 Mar 2014. The health authority reported that the events as non-serious. However, MAH has upgraded the events. The causality of the events was not reported. The Quality Assurance department confirmed that the reported batch number: 006011A, belongs to FLUCELVAX and not FLUVIRIN. The investigation would be performed for FLUCELVAX and not for FLUVIRIN. Therefore the suspect vaccine was changed to FLUCELVAX (previously reported as FLUVIRIN). Follow up report was received from the Quality Assurance department (QA reference number: 305247) on 11 Jun 2014: The suspect vaccine and QA reference number were updated.
Age: 32.0
Sex: F
Vaccine: DTAP
Symptoms: Brain oedema, Dizziness, Dyspnoea, Nausea, Thrombosis
Clinical narrative: Brain swelling trouble breathing I thought I was going to die. I felt blood clots. Nausea vomiting. I almost passed out.
Age: 32.0
Sex: F
Vaccine: DTAP
Symptoms: Vomiting
Clinical narrative: Brain swelling trouble breathing I thought I was going to die. I felt blood clots. Nausea vomiting. I almost passed out.
Age: 13.0
Sex: M
Vaccine: DTAP
Symptoms: Pain, Paraesthesia
Clinical narrative: involuntary shocks, and son would yell out it hurts.
Age: 18.0
Sex: F
Vaccine: MNQ, VARCEL
Symptoms: Convulsion, Electroencephalogram normal
Clinical narrative: Generalized seizure, went to hospital. EEG recorded as normal, neurology follow up recom.
Age: 13.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Injection site erythema, Injection site nodule, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Mother reported on day 4 after vaccine that child started having swelling and redness at injection site 1 hour after vaccine was given.  Softball sized knot at injection site after one day that was hot to touch and had pain from shoulder to elbow. Mom was told to apply cold compresses, give Benadryl and Tylenol and see MD if does not improve. On day 5 child was much better knot almost gone and only a little soreness in shoulder.