chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.36
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Death
Clinical narrative: Initial report was received 11 March 2013 from a health care professional. A four-month-old male patient had received an injection of ACTHIB lot number UH609AA (corresponding sanofi pasteur SA lot number H1123-1), PEDIARIX (manufacturer GSK, lot number AC21B357 and PREVNAR (manufacturer Pfizer, lot number 918175) on 07 March 2013, and two days later on the evening of 09 March 2013, the patient passed away. He had previously received a first dose of RSV vaccine on an unspecified date. The patient had been chronically ill with a history of T fistula with esophageal atresia which was repaired, traceomalacia, PDA (patent ductus arteriosus), PFO (patent foramen ovale), and cardiac issues. He had no known allergies. The event outcome was fatal. Documents held by sender: None.
Sex: M
Vaccine: FLUN3, SMALL
Symptoms: Electrocardiogram normal, Palpitations, Troponin I normal
Clinical narrative: This study case was received from the investigator in a trial on 07 March 2013. A male subject (age and birth date not reported) with no relevant past medical history, experienced mild palpitations, four days after he received an injection of ACAM2000, SP Biologics Co., (lot number, route, site and side not reported) on 14 September 2012. He concomitantly received an injection of FLUMIST, (other manufacturer, lot number, route, site and side not reported) on same day, 14 September 2012; and an injection of ANTHRAX, other manufacturer and HEPATITIS B vaccine, other manufacturer (lot numbers, routes, site and sides not reported) on 13 September 2012. On 18 September 2012, the subject reported onset of mild palpitations in absence of any other cardiac symptoms for short time while lying down, four days post ACAM2000 vaccination. Palpitations were reported as gone upon waking. Rapid Troponin I and electrocardiogram (ECG) were reported as normal on 20 September 2012. Central lab Troponin I was not performed due to specimen processing error on 20 September 2012. The subject did not take any medications to treat the adverse event. The stop date of palpitations, reported as resolved, was 18 September 2012. The subject was referred, but lost to follow-up. The subject was reported as recovered, resolved on 19 September 2012. According to the investigator, the event of palpitations was considered an other important medical event and possibly related to the trial product. Documents held by sender: Medical Record.
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Electrocardiogram, Troponin increased
Clinical narrative: This study case was received from the investigator in a trial on 11 March 2013. A male subject (date of birth not reported) had received the following vaccinations on 28 February 2013: ACAM2000 (lot number, route and site not reported), typhoid (Manufacturer Unknown, lot number, route and site not reported), and anthrax (Other Manufacturer, lot number, route and site not reported). Eight days later, the subject was found to have an elevated Troponin level (adverse event start date reported as 08 March 2013). The troponin lab values were drawn on 07 March 2013 with an elevated value of 0.28 ng/ml. Labs were drawn for re-evaluation but not reported. On 11 March 2013, the subject had an ECG with pending interpretation and referred to medical. The subject reported no chest pain and no cardiac symptoms. No further information was available at the time of the report. The subject's outcome was not recovered. According to the Investigator, the event of elevated troponin was considered an important event and possibly related. Per the Investigator, this represents a case of potential myopericarditis and was referred to the ACAM2000 Myopericarditis Adjudication Committee for assessment. Documents held by sender: None.
Age: 45.0
Sex: M
Vaccine: SMALL
Symptoms: Echocardiogram, Myocarditis
Clinical narrative: This study case was received from the investigator in a trial on 12 March 2013. A 45-year-old male subject, who had a past medical history of palpitations, pounding heart without exercise, and an abnormal electrocardiogram (ECG) on 23 April 2011 (also reported as past medical history, abnormal ECG reported as no), developed non-specific myocarditis on same day after receiving a injection of ACAM2000 (SP Biologics Co., (lot number, site and side not reported) on 12 December 2011. On 12 December 2011, the same day, the subject was diagnosed with non-specific myocarditis. An ECG was reported as abnormal on 23 April 2011 (reported as diagnostic testing, noted in past medical history as prior to vaccine administration). Troponin I result, MRI of brain, MRI of spinal cord, MRI of heart, and lumbar puncture were reported as not performed. Echocardiogram results on unspecified date were reported as not available. Concomitant medications, treatments and hospitalization were not reported. The subject's outcome was not reported. Additional information will be requested from the investigator. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: None.
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Lumbar puncture, Lymphadenitis, Nuclear magnetic resonance imaging brain, Optic neuritis, Visual field tests
Clinical narrative: Lymphadenitis. Optic neuritis - bilateral.
Age: 0.16
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Blood gases abnormal, Dehydration, Diarrhoea, Metabolic acidosis, Metabolic function test abnormal
Clinical narrative: Vomiting, diarrhea, dehydration, metabolic acidosis requiring hospital admission for IV fluids/rehydration.
Age: 0.16
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Vomiting
Clinical narrative: Vomiting, diarrhea, dehydration, metabolic acidosis requiring hospital admission for IV fluids/rehydration.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. On an unknown date the patient hospitalized (reasons unspecified) and vaccinated with PNEUMOVAX 23 (lot # H014653, expiration date was 19-APR-2014, 0.5 ml, subcutaneous). On an unknown date the patient had developed redness, swelling, tenderness in arm at injection site. The outcome of event was unknown. The relationship between events and PNEUMOVAX 23 was unknown. The pharmacist was requesting a lot check for PNEUMOVAX 23 lot H014653 (Expired date 19-APR-2014). This is one of several reports received from the same source. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Borrelia test negative, C-reactive protein normal, Ecchymosis, Erythema multiforme, Full blood count normal
Clinical narrative: Erythema multiformans, ecchymosis, itching and swelling of feet.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Oedema peripheral, Pruritus, Streptococcus test negative, Urine analysis normal
Clinical narrative: Erythema multiformans, ecchymosis, itching and swelling of feet.
Age: 1.49
Sex: M
Vaccine: DTAP
Symptoms: Fall, Muscle rigidity, Opisthotonus, Screaming
Clinical narrative: Father and child returned to clinic with concern reporting that 1/2hr after vaccination that child dropped to floor, started screaming, arching back, and tightening up. This would repeat about every half hour. No redness or swelling at site. No seizures. Instructed to call doctor and report above. Planned to call them 3/15/13. 3/15/13 p.c. 10:00 am to mother. Doctor had been called and had advised to watch him until 3/15/13 and if still same to report back. Dr thought it was possibly d.t. pain associated with very first shot. Mother reported child is better today and that her concern is resolving.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Redness, swelling, soreness, itchiness and tenderness on L arm where he received meningococcal vaccine.  Clinician is treating for cellulitis with antibotics and Tylenol as needed for pain.
Age: 1.42
Sex: M
Vaccine: DTAP, HIBV, MMR, PNC13
Symptoms: Injection site erythema, Vaccination site induration, Vaccination site warmth
Clinical narrative: AREA OF VACCINATION (RIGHT THIGH): HARDENING, REDNESS AND HOT TO THE TOUCH.
Age: 54.0
Sex: M
Vaccine: FLU3
Symptoms: Electromyogram, Joint contracture, Musculoskeletal pain, Neuralgic amyotrophy, Nuclear magnetic resonance imaging
Clinical narrative: Parsonage Turner syndrome, curling of fingers in right hand, shoulder and arm pain.
Age: 54.0
Sex: M
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Parsonage Turner syndrome, curling of fingers in right hand, shoulder and arm pain.
Age: 14.0
Sex: M
Vaccine: HPV4
Symptoms: Abasia, Blood test, Muscular weakness
Clinical narrative: Patient began feeling weakness in his legs and slowly became unable to walk. He was driven to the ER by his parent.
Age: 1.16
Sex: M
Vaccine: VARCEL
Symptoms: Injection site rash, Petechiae
Clinical narrative: Few bumps at left arm site 1-2 days after shot. Then petechiae along left shoulder to wrist over following 7 days.
Age: 39.0
Sex: F
Vaccine: IPV, TDAP
Symptoms: Activities of daily living impaired, Arthralgia, Chills, Dizziness, Fatigue
Clinical narrative: Patient states she felt "not great" after vaccine & for next 3 days. On Friday 3/1/13 had to stay home from work. Low grade fever, aches, chills, dizziness light headedness. On Saturday 3/12/13 her fever "shot up", had joint pains & severe fatigue. This lasted until 3/5/13. Did not feel well for at least an additional week after that. Took ADVIL & homeopathic flu remedy and rest. She feels vaccines lowered her immunity making her move susceptible to catching "something else."
Age: 39.0
Sex: F
Vaccine: IPV, TDAP
Symptoms: Malaise, Pain, Pyrexia
Clinical narrative: Patient states she felt "not great" after vaccine & for next 3 days. On Friday 3/1/13 had to stay home from work. Low grade fever, aches, chills, dizziness light headedness. On Saturday 3/12/13 her fever "shot up", had joint pains & severe fatigue. This lasted until 3/5/13. Did not feel well for at least an additional week after that. Took ADVIL & homeopathic flu remedy and rest. She feels vaccines lowered her immunity making her move susceptible to catching "something else."
Age: 11.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Enlarged area of swelling, redness, warmth measuring 5in by 4in size located right upper arm w/o discharge or streaking.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Pt developed zoster 3 wks after receiving ZOSTAVAX.
Age: 4.0
Sex: M
Vaccine: DTAP, MMR, VARCEL
Symptoms: Erythema, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: RA where vacc was administered reaction swollen, red, hot. Redness extended to forearm. DTaP Aventis Lot # C4335AA.
Age: 26.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Immediate post-injection reaction, Local swelling, Pruritus
Clinical narrative: 3 cm x 5 cm red, swollen area - immediate itchy.
Age: 1.02
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Blood culture positive, Full blood count normal, Injection site erythema, Injection site induration
Clinical narrative: Rt. thigh 1.5 x 2 cm area of erythema & induration on rt lateral thigh. Non tender, without fluctuance, no streaking. Rx clindamycin 10.5mg PO TID x 7 days.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to an unknown number of patients of unknown age whom on an unknown date, were vaccinated with a dose of VARIVAX (Merck) (dose, route of administration and lot # not reported). The registered nurse reported that the patients may have been vaccinated with VARIVAX (Merck) stored at a higher than recommended temperature. No adverse effect reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to an unknown number of patients of unknown age whom on an unknown date, were vaccinated with a dose of ZOSTAVAX (dose, route of administration and lot # not reported). The registered nurse reported that the patients may had been vaccinated with ZOSTAVAX stored at a higher than recommended temperature. No adverse effect reported. This is one of several reports from the same source. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Insomnia
Clinical narrative: This spontaneous report as received from a Registered Nurse (R.N.) refers to a 70 year old female patient with concurrent conditions of hypertension, hyperlipidaemia, gastritis, hypercalcemia, osteoporosis, chronic tubotympanic disease and drug reaction allergies to Niacin, MYCELEX, Iodine, Penicillin, BIAXIN, NEMBUTAL, rash after taking VIOXX, achiness after taking VYTORIN and headaches after taking FOSAMAX. On 27-FEB-2013, the patient received the first dose of PNEUMOVAX23 (lot number H017801, expiration date: 09-JUL-2014) (dose, frequency not reported, intramuscular route in teh gluteal muscle). No other co suspect medications were reported. Concomitant therapies included VALTREX, TYLENOL, NORVASC, RECLAST, omega-3 marine triglyceride, red yeast rice, calcium (unspecified) and ATIVAN (also reported as ATAVAN). On 02-MAR-2013 the patient reported that on 27-FEB-2013 redness, pain and swelling at the injection site. The site was warm to touch and the patient had trouble sleeping. On 03-MAR-2013 the reaction was worse and the patient spoke to the on call physician at the office. The patient went to the emergency room and was given intravenous LEVAQUIN and oral LEVAQUIN to take at home. At the time of the report, the patient's outcome for all adverse events was unknown. This case is linked to MARRS cases #1303USA010401, #1303USA010402, #1303USA010403. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to an unknown number of patients of unknown age whom on an unknown date, were vaccinated with a dose of RECOMBIVAX HB (dose, route of administration and lot # not reported). The registered nurse reported that the patients may had been vaccinated with RECOMBIVAX HB  stored at lower than recommended temperature. No adverse effect reported. This is one of several reports from the same source. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site haemorrhage, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Right pain at injection site, swelling redness, warm to touch, ecchymosis picture provided.
Age: 20.0
Sex: F
Vaccine: PPV
Symptoms: Oedema peripheral, Pyrexia, Tachycardia
Clinical narrative: This spontaneous report was received from a registered nurse refers to a female patient in her 20's. No medical history was reported. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX23 (lot #, dose, route not reported) in the arm. Other suspect therapies included ADACEL (lot#,dose,route not reported) in the same arm. No concomitant medications was reported. On an unknown date, the patient experienced tachycardia, swelling of the arm and fever of 103. Since then the symptoms resolved. No treatment was received. Patient sought medical attention(patient saw the nurse). The outcome of tachycardia, swelling of the arm and fever of 103 was resolved. The relatedness of the events with PNEUMOVAX23 and ADACEL was unknown. Additional information has been requested.
Sex: U
Vaccine: PPV, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. On an unknown date the patient hospitalized (reasons unspecified) and vaccinated with PNEUMOVAX23 (lot # H014653, expiration date was 19-APR-2014, 0.5 ml, subcutaneous). On an unknown date the patient had developed redness, swelling, tenderness in arm at injection site. The outcome of event was unknown. The relationship between events and PNEUMOVAX23 was uknown. THe pharmacist was requesting a lot check for PNEUMOVAX23 lot H014653 (Expired date 19-APR-2014). This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV, PPV
Symptoms: Injection site erythema
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. On an unknown date the patient hospitalized (reasons unspecified) and vaccinated with PNEUMOVAX23 (lot # H014653, expiration date was 19-APR-2014, 0.5 ml, subcutaneous). On an unknown date the patient had developed redness, swelling, tenderness in arm at injection site. The outcome of event was unknown. The relationship between events and PNEUMOVAX23 was uknown. THe pharmacist was requesting a lot check for PNEUMOVAX23 lot H014653 (Expired date 19-APR-2014). This is one of several reports from the same source. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Exposure during pregnancy, Rash, Rash erythematous, Rash pruritic
Clinical narrative: Patient received Flu vaccine at approximately 200 pm on 3/4/13. Later that night, patient developed a red, itchy rash on torso/arms. 5 days later, rash spread to back. Reported to OB/GYN approximately  on 3/15/13, who reported to us. (Pregnant). OB/GYN referred to dermatologist.
Age: 17.0
Sex: U
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse refers to a 17 year old patient, gender unspecified. On 18-MAR-2013 the patient was inadvertently vaccinated with 1 milliliter (ml) VAQTA (lot#, expiration date not reported) intramuscularly. No adverse effects reported. Additional information has been requested.
Age: 1.51
Sex: F
Vaccine: DTAPIPV, HEPA, HIBV
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None.
Sex: U
Vaccine: HPV4
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 and gender. The patient was vaccinated with a first dose of GARDASIL (lot number, expiry date and dose were not reported)series intramuscular on 10-NOV-2011 and the second dose of GARDASIL (lot number, expiry date and dose were not reported) series intramuscular on 29-NOV-2012. No adverse effect reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Oral herpes
Clinical narrative: This spontaneous report as received from a healthcare worker (also reported as office manager) refers to a female patient of unknown age. Approximately on 14-MAR-2013 (reported as 14-MAR-2013 or 15-MAR-2013) the patient was vaccinated with a dose of ZOSTAVAX (lot#, expiration date and route not reported). Approximately on 20-MAR-2013 (reported as over the weekend) this patient developed fever blisters. The patient was given VALTREX for the event. Patient sought medical attention by contacting the Health Care Professional (HCP). The outcome of the event was reported as unknown. Causality was not reported. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Rash, Rash pruritic
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 18 year old female patient with epinephrine allergy. Patients pertinent medical history was none. On 19-OCT-2012, the patient was vaccinated with first dose of GARDASIL (lot number H014615, expiry date 27-MAR-2015 and dose was not reported) intramuscularly. On 28-DEC-2012, the patient was vaccinated with a second dose of GARDASIL (Lot number, expiry date and dose were not reported) intramuscularly. Concomitant therapies included ethinyl estradiol, AVIANE, propanolol hydrochloride(reported as propanolol), PROAIR and MAXALT. On 30-DEC-2012 (reported as 1-2 days after receiving the send dose of vaccination) the patient experienced itchy rash on the trunk and abdomen. The patient sought medical attention (visited the physician). No laboratory test was performed. The event was treated with BENADRYL, CLARITIN and prednisone. The outcome of itchy rash on the trunk and abdomen was unknown. Additional information has been requested,
Sex: U
Vaccine: PPV, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. On an unknown date the patient hospitalized (reasons unspecified) and vaccinated with PNEUMOVAX23 (lot # H014653, expiration date was 19-APR-2014, 0.5 ml, subcutaneous). On an unknown date the patient had developed redness, swelling, tenderness in arm at injection site. The outcome of event was unknown. The relationship between events and PNEUMOVAX23 was unknown. The pharmacist was requesting a lot check for PNEUMOVAX23 lot H014653 (Expired date 19-APR-2014). This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV, PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. On an unknown date the patient hospitalized (reasons unspecified) and vaccinated with PNEUMOVAX23 (lot # H014653, expiration date was 19-APR-2014, 0.5 ml, subcutaneous). On an unknown date the patient had developed redness, swelling, tenderness in arm at injection site. The outcome of event was unknown. The relationship between events and PNEUMOVAX23 was unknown. The pharmacist was requesting a lot check for PNEUMOVAX23 lot H014653 (Expired date 19-APR-2014). This is one of several reports received from the same source. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 13 year old female patient. On 18-MAR-2013, the patient was vaccinated with a second dose of GARDASIL (lot number, expiry date, route and dose were not reported) who had received the first dose approximately on an unknown date in October 2011 9reported as over a year and a half ago). Additional information has been requested.
Sex: U
Vaccine: PPV, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. On an unknown date the patient hospitalized (reasons unspecified) and vaccinated with PNEUMOVAX23 (lot # H014653, expiration date was 19-APR-2014, 0.5 ml, subcutaneous). On an unknown date the patient had developed redness, swelling, tenderness in arm at injection site. The outcome of event was unknown. The relationship between events and PNEUMOVAX23 was unknown. The pharmacist was requesting a lot check for PNEUMOVAX23 lot H014653 (Expired date e 19-APR-2014). This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV, PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. On an unknown date the patient hospitalized (reasons unspecified) and vaccinated with PNEUMOVAX23 (lot # H014653, expiration date was 19-APR-2014, 0.5 ml, subcutaneous). On an unknown date the patient had developed redness, swelling, tenderness in arm at injection site. The outcome of event was unknown. The relationship between events and PNEUMOVAX23 was unknown. The pharmacist was requesting a lot check for PNEUMOVAX23 lot H014653 (Expired date e 19-APR-2014). This is one of several reports received from the same source. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 70 year old female patient with drug reaction of oxycodone (nausea and vomiting), penicillin (skin rash) and codeine (made her crazy). The patient did not have any pertinent medical history. On 14-MAR-2013 the patient was vaccinated with PNEUMOVAX23 (lot # H014653, expiration date was 19-APR-2014, 0.5 ml, subcutaneous) as part of vaccine protocol while hospitalized for hip or knee surgery. Concomitant therapies included atenolol, CELECOXIB, dicyclomine hydrochloride, "ducosate sodium", enoxaparin sodium, ferrous sulfate, levothyroxine sodium, omeprazole, oxycodone, MIRALAX, venlafaxine hydrochloride, TYLENOL, aluminum hydroxide, magnesium hydroxide, MAALOX, bisacodyl, diphenhydramine hydrochloride, acetaminophen, LORTAB, morphine, ZOFRAN, AMBIEN and ropivacaine. On 14-MAR-2012, the patient had developed redness, swelling, tenderness in the arm at injection site. The outcome of events was unknown. Pharmacist stated patient being discharged from hospital 15-MAR-2013. No lab diagnosis studies performed. No treatment was given for adverse events. The relationship between events and PNEUMOVAX23 was unknown. The pharmacist was requesting a lot check for PNEUMOVAX23 lot H014653 (Expired date 19-APR-2014). This is one of several reports received from the same source. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal X-ray, Abdominal pain, Blood test, Decreased appetite, Nuclear magnetic resonance imaging abdominal
Clinical narrative: After 1st dose; pt experienced abdominal pain after 2nd dose; pt experienced increased abdominal pain after 3rd dose; still experiencing abdominal pain; weight loss, decreased appetite.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Vaccine positive rechallenge, Weight decreased
Clinical narrative: After 1st dose; pt experienced abdominal pain after 2nd dose; pt experienced increased abdominal pain after 3rd dose; still experiencing abdominal pain; weight loss, decreased appetite.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a registered nurse concerning a female patient of unknown age. On 13-MAR-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiry date, dose and route unspecified). No concomitant medications were reported. On an unknown date, prior to the vaccination, the patient had seen the physician due to rash. The physician felt that it could be shingles. The patient was prescribed with acyclovir. The patient was told by the physician to check into the availability and price of ZOSTAVAX for the future but not suppose to get vaccinated. The patient misunderstood and went to a pharmacy who was offering ZOSTAVAX and was vaccinated before she started taking acyclovir. Reporter stated that the patient took acyclovir after the vaccination. Outcome of shingles was better since taking the acyclovir. The relatedness for shingles was unknown for ZOSTAVAX. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling, Local reaction
Clinical narrative: Large local reaction, erythema & swelling bil deltoids.
Age: 3.0
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative, Blood immunoglobulin M, Headache, Oropharyngeal pain, Rash generalised
Clinical narrative: This spontaneous report was received from a physician's assistant refers to a 9 year old female patient. No medical history was reported. The patient was vaccinated with 2 doses of VARIVAX (Merck) (lot #, dose, route not reported) on 28-OCT-2005 and 30-DEC-2002. No concomitant medications were reported. Since that time the patient has experienced two episodes of chickenpox. The first episode appeared on 03-NOV-2011. The chickenpox rash appeared on her abdomen, buttocks, and face and the rash eventually resolved. The second episode appeared on 12-MAR-2013 and was still ongoing. The chickenpox rash is disseminated all over her body. In addition, the patient has a sore throat and a headache. Patient sought medical attention. At the office the patient was tested for antibodies and the IgG was negative and were waiting for the IgM results. The outcome of sore throat and headache was reported as not recovered. The outcome of IgG was negative was unknown. Additional information has been requested.
Age: 3.0
Sex: F
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: This spontaneous report was received from a physician's assistant refers to a 9 year old female patient. No medical history was reported. The patient was vaccinated with 2 doses of VARIVAX (Merck) (lot #, dose, route not reported) on 28-OCT-2005 and 30-DEC-2002. No concomitant medications were reported. Since that time the patient has experienced two episodes of chickenpox. The first episode appeared on 03-NOV-2011. The chickenpox rash appeared on her abdomen, buttocks, and face and the rash eventually resolved. The second episode appeared on 12-MAR-2013 and was still ongoing. The chickenpox rash is disseminated all over her body. In addition, the patient has a sore throat and a headache. Patient sought medical attention. At the office the patient was tested for antibodies and the IgG was negative and were waiting for the IgM results. The outcome of sore throat and headache was reported as not recovered. The outcome of IgG was negative was unknown. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report was received from a registered nurse concerning a 15 year old female patient. On an unknown date, approximately in September 2011 (over a year and a half ago), the patient was vaccinated with dose 1 of GARDASIL (lot number, expiry date, dose and route unspecified). On 18-MAR-2013, the patient was vaccinated with dose 2 of GARDASIL (lot number, expiry date, dose and route unspecified). No concomitant medications were reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report as received from a pharmacy student refers to a patient of unknown age. On an unknown date the patient was vaccinated (route unknown) with ZOSTAVAX (lotnumber and expiry date not reported). The pharmacy student reports that a patient inadvertently received a second dose of ZOSTAVAX about 2 years after the first dose. The outcome of received a second dose of ZOSTAVAX about 2 years after the first dose is unknown. The reporter considered received a second dose of ZOSTAVAX about 2 years after the first dose to be not related to ZOSTAVAX. Additional information has been requested.
Age: 39.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site induration, Injection site swelling, Injection site warmth, Rash
Clinical narrative: This spontaneous report as received from a 39 year old male patient with FLEXERIL allergy. On 12-MAR-2013 the patient was vaccinated with ZOSTAVAX (route, dose and lot # were unknown) in the right arm. On 12-MAR-2013, the patient noticed a few bumps on his neck, injection site swollen, warn and hard to the touch the rash was from the right side going across shoulder to the left side and down almost to the injection site. Next day on 13-MAR-2013 his physician instructed to take BENADRYL and if rash did not go away by 14-MAR-213 to call physician back for further instruction for treatment. The patient was prescribed the KEFLEX and MEDROL 4 mg for the reaction to ZOSTAVAX, the patient also stated a second vaccine was given in the same arm on the same day it was called Tetnus (with whooping cough) he believed it was called T-dat diphtheria, pertusis) however this site of the ZOSTAVAX was the only site that felt warm to the touch, swollen and hard lump. No lab diagnosis studies performed. The patient had sought medical attention. The outcome of events was unknown. The relationship between events and ZOSTAVAX was unknown. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a physician concerning a female patient of unknown age. On an unknown dates, approximately in 2011 (2 years ago), the patient was vaccinated with dose 1 and dose 2 of GARDASIL (lot number, expiry date, dose and route unspecified) and the patient would like to receive her dose 3 of GARDASIL (lot number and expiry date unspecified) at the time of reporting. No concomitant medications were reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Varicella
Clinical narrative: This spontaneous report as received from a health care professional via company representative refers to a female patient of unknown age. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX, (lot number, expiry date and route was not reported). Concomitant medications were not reported. On an unknown date, the patient was administered ZOSTAVAX and broke out with chickenpox. The outcome of the event was unknown. Additional information is not expected.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Blood test normal, Borrelia test negative, Epstein-Barr virus test negative, Fatigue, Mononucleosis heterophile test negative
Clinical narrative: This spontaneous report was received from a triage coordinator concerning 11 year old female patient with asthma, who on 09-JUL-2012 was vaccinated with dose 1 of GARDASIL (lot number 0459AE) and on 16-NOV-2012 was vaccinated with dose 2 of GARDASIL (lot # H013831). Concomitant therapies included ASMANEX and VERAMYST. It was reported that in approximately 15-DEC-2012 (reported as the middle of December) the patient developed extreme fatigue. On an unknown date, the patient was seen by the Rheumatologist and had a blood work; a Lyme work up, thyroid EB, mono evaluation and Epstein Barr work-up and this entire test had been negative. No treatment information was reported. At the time of the report, the patient had not recovered from the event. The reporting triage coordinator considered the event of extreme fatigue to be significant disability or incapacity as the patient felt tired after participating in sports. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Thyroid function test normal
Clinical narrative: This spontaneous report was received from a triage coordinator concerning 11 year old female patient with asthma, who on 09-JUL-2012 was vaccinated with dose 1 of GARDASIL (lot number 0459AE) and on 16-NOV-2012 was vaccinated with dose 2 of GARDASIL (lot # H013831). Concomitant therapies included ASMANEX and VERAMYST. It was reported that in approximately 15-DEC-2012 (reported as the middle of December) the patient developed extreme fatigue. On an unknown date, the patient was seen by the Rheumatologist and had a blood work; a Lyme work up, thyroid EB, mono evaluation and Epstein Barr work-up and this entire test had been negative. No treatment information was reported. At the time of the report, the patient had not recovered from the event. The reporting triage coordinator considered the event of extreme fatigue to be significant disability or incapacity as the patient felt tired after participating in sports. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: No therapeutic response, Rubella antibody negative
Clinical narrative: This spontaneous report as received from a physician refers to his friend of unknown age. On an unknown date the patient was vaccinated with M-M-R II (lot number not provided). The patient had a negative titer to Rubella as an adult, following completion the primary M-M-R II series as a child(other titers were acceptable). Unspecified titer was performed). No adverse event reported other than the negative titer to Rubella. The outcome of adverse event was unknown. It was unspecified if the patient had sought medical attention. Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster disseminated
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a patient of unknown age. On an unknown  date the patient was vaccinated with ZOSTAVAX (lot number, expiry date, route and site not reported). On an unknown date the patient experienced disseminated zoster. The outcome of disseminated zoster was unknown at reporting time. The reporter considered disseminated zoster to be related to ZOSTAVAX. It was unspecified if the patient had sought medical attention. Additional information has been requested.
Age: 48.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site reaction, Oedema peripheral
Clinical narrative: This spontaneous report was received from a 48 year old female patient who is also a registered nurse regarding herself. Patient's current condition included kidney disease. On 18-MAR-2013, the patient was vaccinated with a dose of PNEUMOVAX23(lot#,dose not reported), intramuscularly. No concomitant medications were reported. On an unknown date about 2 months ago in January 2013, the 48 year old patient received a pediatric PNEUMOVAX23(lot# ,dose not reported) and did not have a reaction. On 18-MAR-2013, the patient experienced injection site reaction. Her left upper arm was 2.5 inches larger than her right arm. She had edema and redness from her left elbow to her shoulder. Her left upper arm was 2.5 inches larger than her right arm. She has edema and redness from her left elbow to her shoulder. Treatment included ice, BENADRYL and TYLENOL. Patient sought medical attention(called physician). The patient is on the kidney transplant list for a new kidney. The outcome of injection site reaction, her left upper arm is 2.5 inches larger than her right arm, redness from left elbow to her shoulder and edema was reported as not recovered. The relatedness for the events with PNEUMOVAX23 was unknown. Additional information has been requested.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Pruritus
Clinical narrative: Spreading redness and itching, treated with Keflex 500 mg QID X 10 days.
Age: 1.04
Sex: F
Vaccine: HIBV, MMR
Symptoms: Abnormal faeces, Diarrhoea, Injection site erythema, Injection site pain, Injection site urticaria
Clinical narrative: Welt, redness, and soreness at injection sight.  Very odorous diarrhea that contained large amounts of mucus; 5 occurrences.
Age: 1.04
Sex: F
Vaccine: HIBV, MMR
Symptoms: Mucous stools
Clinical narrative: Welt, redness, and soreness at injection sight.  Very odorous diarrhea that contained large amounts of mucus; 5 occurrences.
Age: 16.0
Sex: M
Vaccine: FLUX, HEPA, HPV4, FLU3, HEPA, HPV4
Symptoms: Abdominal pain, Blood test, Diarrhoea, Diplopia, Dizziness
Clinical narrative: Migraines, severe pain in arms and legs, stabbing abdominal pain, diarrhea, double vision, dizziness, nausea, weakness in left arm.
Age: 16.0
Sex: M
Vaccine: FLUX, HEPA, HPV4, FLU3, HEPA, HPV4
Symptoms: Electrocardiogram, Migraine, Muscular weakness, Nausea, Pain in extremity
Clinical narrative: Migraines, severe pain in arms and legs, stabbing abdominal pain, diarrhea, double vision, dizziness, nausea, weakness in left arm.
Age: 16.0
Sex: M
Vaccine: FLUX, HEPA, HPV4, FLU3, HEPA, HPV4
Symptoms: Abdominal pain upper, Headache, Pain in extremity
Clinical narrative: Migraines, severe pain in arms and legs, stabbing abdominal pain, diarrhea, double vision, dizziness, nausea, weakness in left arm.
Age: 22.0
Sex: F
Vaccine: HEPAB
Symptoms: Pain in extremity
Clinical narrative: STIFF PAIN SHOOTING DOWN ARM INTO FINGER TIPS A FEW SECONDS AFTER SHOT.
Age: 0.15
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Crying, Immediate post-injection reaction, Injection site pain, Insomnia, Pyrexia
Clinical narrative: My daughter immediately was sore at the vaccine site, which by 3:30 was so bad she could not be touched on her legs at all.  She also developed a fever by the afternoon, over 101.  I gave her Tylenol, as directed by the doctor.  By 7:00 pm, she was screaming for hours and could not be consoled.  She vomited three times over night and would not sleep more than 20 minutes at a time all night.  She was not back to normal for days.
Age: 0.15
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Screaming, Vomiting
Clinical narrative: My daughter immediately was sore at the vaccine site, which by 3:30 was so bad she could not be touched on her legs at all.  She also developed a fever by the afternoon, over 101.  I gave her Tylenol, as directed by the doctor.  By 7:00 pm, she was screaming for hours and could not be consoled.  She vomited three times over night and would not sleep more than 20 minutes at a time all night.  She was not back to normal for days.
Age: 24.0
Sex: F
Vaccine: HEP, HPV4
Symptoms: Chest discomfort, Dysphagia, Dyspnoea, Rash, Wheezing
Clinical narrative: Adverse reaction occurred after the patient was discharged from clinic and went home. States she had difficulty breathing and rash on her neck. She was taken to the emergency room by family and treated. Reaction resolved after treatment. She also states she took Ibuprofen 5-10 minutes before reaction occurred. Hospital records show Pt. walked in to ER at 1315 with difficulty breathing, difficulty swallowing, chest tightness, wheezing and rash over throat and neck. She was treated with 25mg of IV Benadryl, 125mg of IV Prednisone and 20 mg of IV Famotidine.
Age: 26.0
Sex: M
Vaccine: HPV4
Symptoms: Haemangioma
Clinical narrative: Pt. developed a hemangioma at the injection site.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Convulsion, Syncope
Clinical narrative: Patient recieved HPV vaccine. Patient did not eat before she came in. Informed patient to sit down for 5 to 10 minutes to make sure she felt ok. Mother insisted they had to leave. I informed mother that if patient did not feel well to have her lay down immediately. As patient was walking out of the room the mother yelled for my name. I approached patient and mother was holding her sitting up on the ground. As I approached patient was fainting with seizure activity. I immediately placed patient flat on the ground. After a few seconds patient started to recover. After 30 seconds patient was fully recovered. BP 124/61. Patient laid for a few minutes. Sat patient up BP 116/80. Stood patient up BP 117/74 and walked patient to car. Notified patient to lay down if she starts to not feel good again and to go to ER or 911 if patients does not recover. Also informed patient to eat when she gets up in the morning.
Age: 12.0
Sex: F
Vaccine: FLU3
Symptoms: Ileus paralytic
Clinical narrative: Case number PHEH2013US006415 is an initial spontaneous report received from a consumer (patient's mother) who is also a healthcare professional on 18 Mar 2013. This report refers to a 12 year-old female patient. Her medical history and concomitant medications was not reported. She was vaccinated with FLUVIRIN (batch number: not reported) on an unspecified date. Three days after vaccination, she developed paralytic ileus. The event outcome, seriousness and causality were not reported.
Age: 27.0
Sex: F
Vaccine: HEPA, TYP
Symptoms: Culture stool negative, Diarrhoea, Haematochezia, Headache, Muscle spasms
Clinical narrative: Client took all 4 oral typhoid capsules on schedule with only mild cramping after each dose. The night she completed dose 4 she had severe cramps, HA, T = 103 F. 2 days later she had bloody stool, diarrhea, and fever continued, cramps continued. Went to hospital, given rehydration, stool test neg for typhoid. All sympt resolved approximately 1 day later.
Age: 27.0
Sex: F
Vaccine: HEPA, TYP
Symptoms: Pyrexia
Clinical narrative: Client took all 4 oral typhoid capsules on schedule with only mild cramping after each dose. The night she completed dose 4 she had severe cramps, HA, T = 103 F. 2 days later she had bloody stool, diarrhea, and fever continued, cramps continued. Went to hospital, given rehydration, stool test neg for typhoid. All sympt resolved approximately 1 day later.
Age: 11.0
Sex: M
Vaccine: HPV4
Symptoms: Convulsion, Dizziness postural, Malaise, Syncope
Clinical narrative: Patient recieved HPV vaccine. Patient did not eat before and did not get much sleep the night before. After a minute patient stated he did not feel well and started to faint. Patient also had seizure activity. I immediately put patient on exam table and he immediately recovered BP 94/51. Patient laid for 5 minutes and felt better. Sat patient up and gave water BP 93/60. Stood patient up and felt dizzy again. Laid patient down for a few minutes and sat patient up again. Gave patient a sucker to suck on. Stood patient up and felt dizzy again. Laid patient back down for 5 minutes. Sat patient up and gave orange juice. Stood patient up and he felt dizzy again. Laid patient down for 5 minutes BP 90/42. Sat patient up and gave patient crackers BP 100/66. Patient stated he felt alot better now. Stood patient up and he stated he felt good enough to walk BP 86/58. Walked patient to car. Informed patient to eat more and get more sleep. Also to go home and rest for a while. Also informed patient if he gets worse to go to ER or call 911.
Age: 1.54
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Eye swelling, Pyrexia, Rash erythematous, Rash generalised, Swelling face
Clinical narrative: Rash (small red dots) all over chest, neck and back. Then spread to arms, face and legs with fever ranging from 99.0-102.0 throughout the 5 days she had it. Also swelling of the eyes and cheeks.
Age: 1.25
Sex: F
Vaccine: DTAP, HIBV, PNC13
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Pt developed redness, pain at injection site.
Age: 0.73
Sex: M
Vaccine: FLU3
Symptoms: Condition aggravated, Hepatic haematoma, Hepatic haemorrhage, Platelet count decreased, Shunt occlusion
Clinical narrative: Patient was brought to hospital in acute distress with tachypnea and ventriucular tachycardia.  Patient was stablilized and found to have severe thrombocytopenia (12K) and a large hepatic bleed/hematoma.  Of note patient was on Lovenox for prior intracardiac shunt occlusion.  Also, history of intermittent thrombocytopenia with last known values 11/15= 49k, 11/18 35k.
Age: 0.73
Sex: M
Vaccine: FLU3
Symptoms: Tachypnoea, Thrombocytopenia, Ventricular tachycardia
Clinical narrative: Patient was brought to hospital in acute distress with tachypnea and ventriucular tachycardia.  Patient was stablilized and found to have severe thrombocytopenia (12K) and a large hepatic bleed/hematoma.  Of note patient was on Lovenox for prior intracardiac shunt occlusion.  Also, history of intermittent thrombocytopenia with last known values 11/15= 49k, 11/18 35k.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Skin warm
Clinical narrative: 40mm circular erythemic area, warm to touch.
Age: 1.03
Sex: M
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Urticaria
Clinical narrative: HIVES.
Age: 15.0
Sex: F
Vaccine: HEPA, TYP, YF
Symptoms: Incorrect dose administered
Clinical narrative: Administered adult dose of 1.0 cc Havrix Hepatitis A vaccine to Patient. Who should have received 0.5 cc dose.
Age: 24.0
Sex: F
Vaccine: HEPAB, IPV, TDAP
Symptoms: Injected limb mobility decreased, Injection site mass, Injection site pain, Injection site swelling
Clinical narrative: The patient experienced swelling at the Tdap injection site on right lower deltoid developed 3-5 days after vaccination given 3/1/13. The swelling created a mass under the skin the size of a quarter initially. It was very painful and tender to the touch or with use of her arm. The site of the Tdap vaccination on right arm on 3/14/13 still had a solid lump under the skin the size of a grape, it was no longer painful at this time. On 3/21/13 the solid lump under the skin remains the size of a dime. Other vaccinations administered on 3/1/13 included Ipol  IM right upper delt & Twinrix IM left deltoid, which resulted in no adverse events.