chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 56.0
Sex: F
Vaccine: PPV
Symptoms: Local swelling, Pain, Paraesthesia, Pyrexia
Clinical narrative: This spontaneous report as received from a physician and a nurse via a company representative refers to a 56 year old female patient. Concomitant medication and pertinent medical history were not provided. On 04-JUN-2014 the patient was vaccinated with PNEUMOVAX 23 (injection, lot # J011998, expiration date 12-FEB-2015, 1 shot, dose and route were unspecified). The injection was given above the normal injection site area, in the shoulder joint. On 04-JUN-2014, "within an hour or two" of receiving PNEUMOVAX 23, the patient had extreme pain in the injection arm. The patient experienced loss of movement in the right (injection) arm; she could not lift the limb and the pain gradually increased to where she couldn't sleep, movement was painful, and there was obvious swelling and a tingling and burning sensation up and down the arm. In addition, the patient had a fever of 102F-103F. The patient went to urgent care for medical attention and was put on an unspecified "prednisone pack" (manufacture unknown) (dose, route and frequency were not provided) for 6 days. When the pack was removed, the pain and fever returned. No lab diagnostics studies were performed. The outcome of the events was reported as not recovered. Causality assessment was not provided by the reporter. The reporter considered the adverse events resulted in significant disability and incapacity. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: HPV4
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Had Gardasil vaccine at school physical on 6/18/14. Woke at 0330 itching with rash around neck and back, then turned into large welts.  The rash extended down his trunk. He received Benadryl and Zantac at home. No respiratory involvement, given prescripton for prednisone.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 16-JUN-2014 the patient was vaccinated with improperly stored M-M-R II (subcutaneous, 0.5 ml). Pertinent medical history and concomitant medications were not reported. The reported stated M-M-R II was exposed to a temperature of 8.4 C for less than 10 minutes. No adverse effects Reported. The outcome of the event was unknown. No further information was provided. Additional information has been requested.
Age: 59.0
Sex: F
Vaccine: YF, YF
Symptoms: Eye pruritus, Flushing, Nasal discomfort, Respiratory distress, Throat tightness
Clinical narrative: Nose and eyes itching, flushed face, closing throat, respiratory distress. Epinephrine and Benadryl given, 4:00 PM. Methylprednisolone - 6 days.
Age: 59.0
Sex: F
Vaccine: YF, YF
Symptoms: Cough, Dizziness, Dyspnoea, Nasal discomfort
Clinical narrative: Nose and eyes itching, flushed face, closing throat, respiratory distress. Epinephrine and Benadryl given, 4:00 PM. Methylprednisolone - 6 days.
Age: 57.0
Sex: F
Vaccine: YF, YF
Symptoms: Eye pruritus, Flushing, Nasal discomfort, Respiratory distress, Throat tightness
Clinical narrative: Patient stated she has egg allergy.  However she must have YV vaccine to travel out of the country.  States allergy is not severe.   After admin of YF vaccine, patient states she felt dizzy and her nose was itching. Patient was fanned.  Patient refused ice pact and Benadryl.  Patient began to cough and stated  she was having trouble breathing.  Patient requested nurse to administer patient's personal Epi Pen. Nurse administered clinic Epinephrine.  Patient transported to ER across the street via wheelchair
Age: 57.0
Sex: F
Vaccine: YF, YF
Symptoms: Cough, Dizziness, Dyspnoea, Nasal discomfort
Clinical narrative: Patient stated she has egg allergy.  However she must have YV vaccine to travel out of the country.  States allergy is not severe.   After admin of YF vaccine, patient states she felt dizzy and her nose was itching. Patient was fanned.  Patient refused ice pact and Benadryl.  Patient began to cough and stated  she was having trouble breathing.  Patient requested nurse to administer patient's personal Epi Pen. Nurse administered clinic Epinephrine.  Patient transported to ER across the street via wheelchair
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to unspecified number of patients of unknown demographics. On an unknown date, and unspecified number of patients may have received ROTATEQ 0.5 milliliters suspension, orally (Lot# J008364, expiration date: 27-FEB-2015). The reporter reported that ROTATEQ were exposed to a lowest temperature of 32F (Fahrenheit) for a total of 1 hour over "four different occasions" and the improperly stored ROTATEQ were administered orally to an unspecified amount of patients. No adverse effect was reported. There was no product quality complaint involved. Outcome of medication error was unknown. The case is linked to 1405USA004024, 1405USA011937, 1405USA011938, 1405USA009508, 1405USA011939, 1406USA009955, 1406USA009970, 1406USA009971, 1406USA009972, 1406USA009973, 1406USA009977 and 1406USA009978 (same reporter link). Additional information has been requested.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Rash
Clinical narrative: This spontaneous report as received from a physician refers to a 84 year old female patient with drug reactions/allergies to erythromycin, sulfa, iodine and quinolones, and no medical history. On 10-JUN-2014 the patient was vaccinated with a dose of ZOSTAVAX for preventative ( lot#, dosage and route not reported). On 12-JUN-2014, "2 days later" after vaccination, the patient developed "eruptions or blisters" on both of her forearms. The patient went to the emergency room on an unspecified date regarding the reaction. The physician stated the patient was given ATARAX (ALPRAZOLAM) at the hospital but "she's not taking it right now" by the time of this report. The physician stated the patient was not admitted to the hospital. The physician stated the patient was seen in his office on 16-JUN-2014, and was taking BENADRYL for the reaction by the time of this report. When asked the patient's present status the physician stated "it's already subsiding" by the reporting time. The causal relationship was not reported. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site nodule, Injection site pruritus, Injection site warmth
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 24 year old female patient. The patient was not pregnant at the time of this report. None of pertinent medical history and drug reactions/allergies reported. On 16-OCT-2013 the patient was vaccinated with the first dose of GARDASIL, 0.5 ml, intramuscular (lot# not reported). No concomitant medication reported. Approximately on 16-OCT-2013, after receiving the first dose of GARDASIL, the patient experienced hotness, itchiness and a red knot at the injection site. The patient did not seek medical attention. The outcome of event was reported as recovered/resolved. The causality between vaccine and events was not reported. 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 healthcare worker refers to an unspecified number of patients. On 10-JUN-2014, an unspecified number of patients were administered VARIVAX (lot#, expiration date, dose, route and indication not reported) that were exposed to improperly stored temperatures outside the product insert. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 19.0
Sex: M
Vaccine: SMALL
Symptoms: Blister, Exposure to vaccinated person, Lymph node pain, Orthopoxvirus test positive, Polymerase chain reaction
Clinical narrative: 19 yr old male with vesicles on left upper arm in area of recent tattoo placed 01 Jun. Per pt roommate was vaccinated with SPV on 20 May. Pt did not receive vaccine. Pt reported on 08 Jun, 1 wk post tattoo, he noticed the appearance of bumps on the upper area of his tattoo. The increased in size, were red, and he reports tender lymph nodes in his armpit. He denies fever. Was seen at clinic and sent to derm today for evaluation. Specimens obtained including culture for PCR on 13 Jun. SPV precautions reviewed with pt. Specimen pos for PCR. F/U on 17 Jun. Pt doing well. Area healing nicely. No drainage. NO new lesions.
Age: 19.0
Sex: M
Vaccine: SMALL
Symptoms: Rash erythematous
Clinical narrative: 19 yr old male with vesicles on left upper arm in area of recent tattoo placed 01 Jun. Per pt roommate was vaccinated with SPV on 20 May. Pt did not receive vaccine. Pt reported on 08 Jun, 1 wk post tattoo, he noticed the appearance of bumps on the upper area of his tattoo. The increased in size, were red, and he reports tender lymph nodes in his armpit. He denies fever. Was seen at clinic and sent to derm today for evaluation. Specimens obtained including culture for PCR on 13 Jun. SPV precautions reviewed with pt. Specimen pos for PCR. F/U on 17 Jun. Pt doing well. Area healing nicely. No drainage. NO new lesions.
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified patients of unknown age and gender. On and unknown date the patients were vaccinated with M-M-R II dose, indication, route of administration and lot# were not reported. On unknown date in 2014, the unspecified number of patients received M-M-R II which was inadvertently mixed with expired, sterile diluent (expiration was on 12-MAY-2014). No adverse effects were reported. 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 VARIVAX (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 mentioned above that the 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 event 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 VARIVAX temperature excursion and one patient of unspecified age gender who was vaccinated with VARIVAX (injection, strength, dose, frequency, route of administration and indication were not provided)(lot# J012384, exp date: 31-OCT-2015) that reached 18.5 F  for 10 hours and 44 minutes. This is one 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 VARIVAX (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 mentioned above that the 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 event information was available. Follow up information has been received from nurse providing information VARIVAX temperature excursion such affected lot numbers, expiration dates and patient ID. Two patients were vaccinated with VARIVAX (injection, strength, dose, frequency, route of administration) (lot# J012384, exp. date: 27-MAR-2015) that reached 18.5 F for 10 hours and 44 minutes. This is one several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: MMR
Symptoms: Abnormal sensation in eye, Accidental exposure to product
Clinical narrative: This spontaneous report as received from a nurse refers to a female patient (also nurse) of unknown age. On 04-JUN-2014 the patient in advertently splashed M-M-R II in her left eye. The patient sought medical attention in an office. No hospitalization was involved. None laboratory diagnostics were performed. The left eye was splashed with water and was "feeling sticky" at the time of the report (04-JUN-2014). The relatedness between "feels sticky" and M-M-R II was not reported. 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 VARIVAX (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, the reporter stated that their in house stability data could support those conditions mentioned above that the VARIVAX was exposed to. No concomitant medication was reported. No 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 nurse concerning VARIVAX temperature excursion and one patient of unspecified age and gender who was vaccinated with VARIVAX (injection, strength, dose, frequency, route of administration and indication were not provided) (lot# J012384, exp. date: 31-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: 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 VARIVAX (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 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 nurse providing information VARIVAX temperature excursion such as affected lot numbers, expiration dates and patient ID. was vaccinated with VARIVAX injection, (strength, dose, frequency, route of administration and indication were not provided) (lot# J008652, exp. date: 10-JUL-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: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Skin burning sensation, Skin sensitisation
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 72 year old female patient with no drug allergies. Medical history and concurrent conditions were not reported. On 22-MAY-2014 the patient was vaccinated in the left arm with first dose of ZOSTAVAX (subcutaneous, lot # J012659, expiry date: 01-JAN-2015). Concomitant medications were not reported. On 22-MAY-2014 the patient experienced redness at the ZOSTAVAX injection site. The pharmacist reported that on 22-MAY-2014 the patient also developed a "dull burning or skin sensitivity from the neck to the right shoulder, from above the right wrist into the right hand, from ribs to waist, and from below the right knee to the top of the right foot". It was reported that no treatment was given and no lab diagnostics were performed. The patient sought medical attention and called the pharmacist. It was reported that on an unknown date in 2014 the patient recovered from the injection site redness. At the time of this report the patient did not recovered from dull or skin sensitivity. The relatedness between ZOSTAVAX and injection site redness, dull burning or skin sensitivity was not reported. PQC was not involved. 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 physician refers to unspecified number of patients of unknown demographics. On an unknown date, an unspecified number of patients may have received ROTATEQ 0.5 millilitres suspension, orally (Lot# J001814, expiry date: not provided). The reporter reported that ROTATEQ were exposed to a lowest temperature of 32F (Fahrenheit) for a total of 1 hour over "four different occasions" and the improperly stored ROTATEQ were administered orally to an unspecified amount of patients. No adverse effect was reported. There was no product quality complaint involved. The case is linked to 1405USA004024, 1405USA011937, 1405USA011938, 1405USA009508, 1405USA011939, 1406USA009970, 1406USA009971, 1406USA009972, 1406USA009973, 1406USA009974, 1406USA009977 and 1406USA009978 (same reporter link). Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: MMR
Symptoms: Mumps antibody test negative, Viral titre decreased
Clinical narrative: This spontaneous report as received from a physician refers to a 19 year old female patient. On an unknown date the patient was vaccinated with M-M-R II. Route, dose, dose number and frequency were not reported. Concomitant medication, pertinent medical history and drug reactions/allergies were reported as none. The physician reported that a patient that received MMR "as a child" on an unspecified date, had titers drawn on 19-MAY-2014 and the physician reported that the titers showed that the patient was not immune to measles or mumps. No treatment was given. The outcome of the titers showed that the patient was not immune to measles or mumps is unknown. Reporter causality assessment was not reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to an unspecified number of patients of unknown ages and genders. On unknown dates the patients were administered with GARDASIL (lot#, route and dose not reported) 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: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified number of patients of unknown ages and genders. She reported that PNEUMOVAX 23, GARDASIL (1406USA004040) and ROTATEQ (1406USA005480) were exposed to temperatures outside the recommended range at 30.6F for 36 hours. She stated that the exposure occurred on 23-MAY-2014, and that since then, the unspecified number of patients had received doses of all three vaccine (lot#, dose and route not reported). M-M-R II was involved. But M-M-R II did not go out of temperature range in this case. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified number of patients of unknown ages and genders. She reported that GARDASIL, PNEUMOVAX 23 (MARRS# 1406USA005479), and ROTATEQ (MARRS# 1406USA005480) were exposed to temperatures outside of recommended range at 30.6F for 36 hours. She stated that the exposure occurred on 23-MAY-2014, and that since then, the unspecified number of patients had received doses of all three vaccines (lot#, dose and route not reported). MMR II was involved. But MMR II did not go out of temperature range in this case. No adverse effects were reported. 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 nurse refers to unspecified number of patients of unknown ages and genders. She reported that ROTATEQ, PNEUMOVAX 23 (MARRS# 1406USA005479) and GARDASIL (MARRS# 1406USA004040) were exposed to temperatures outside of recommended range at 30.6F for 36 hours. She stated that the exposure occurred on 23-MAY-2014, and that since then, the unspecified number of patients had received doses of all three vaccine (lot# and dose not reported). M-M-R II was involved. But M-M-R II did not go out of temperature range in this case. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site inflammation, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Inflamed the injection site and started spreading raised and hot to touch w/ bump in middle. Also carried a fever. Went to Medical Center prescribed KEFLEX which was changed to Azithromycin due to allergy.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Eye irritation, Eye pruritus, Hypersensitivity, Oral discomfort
Clinical narrative: BURNING/ITCHING OF EARLOBE & LIPS (LFT SIDE), FOLLOWED BY SAME SYMPTOM -LFT EYE AND THEN TIP OF NOSE. (MY USUAL ALLERGIC REACTION TO MEDICATION).  TREATING W/BENADRYL - 25MG AS NEEDED. 2:55 PM, 3:55 PM, 7:05PM, 10:20PM, 11PM AND THEN 10 AM ON 06/20/2014.  WILL CONTINUE W/TREATMENT UNTIL ALL SYMPTOMS SUBSIDE.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus
Clinical narrative: BURNING/ITCHING OF EARLOBE & LIPS (LFT SIDE), FOLLOWED BY SAME SYMPTOM -LFT EYE AND THEN TIP OF NOSE. (MY USUAL ALLERGIC REACTION TO MEDICATION).  TREATING W/BENADRYL - 25MG AS NEEDED. 2:55 PM, 3:55 PM, 7:05PM, 10:20PM, 11PM AND THEN 10 AM ON 06/20/2014.  WILL CONTINUE W/TREATMENT UNTIL ALL SYMPTOMS SUBSIDE.
Age: 0.19
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Eczema
Clinical narrative: Rash, explained by mother as comprable to eczema, on child's body.
Age: 1.68
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling, Pyrexia, Vomiting
Clinical narrative: Fever to 103, Vomiting, Local redness and swelling of injection site (thigh).
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Abnormal behaviour, Hallucination, Nightmare, Screaming
Clinical narrative: Nightmares, hallucinations, tearing off her clothes, screaming outbursts lasting a few hours with reoccurrence of acute episodes triggered by wearing clothes.
Age: 34.0
Sex: F
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 34 year old female patient. On 19-DEC-2013 the patient was vaccinated with a first dose of GARDASIL, injection (lot #, expiration date and dose was not reported) and on 03-JAN-2014 the patient was vaccinated with a second dose of GARDASIL, injection (lot #, expiration date and dose was not reported). The primary reporter stated that patient was in office (approximately in 2014, date estimated) to receive the third dose of GARDASIL. No adverse event was reported. Additional information has been requested.
Age: 1.39
Sex: M
Vaccine: MMRV
Symptoms: Dermatitis diaper, Pyrexia, Rash
Clinical narrative: 6/12/14 had low grade fever 2x days and rash on trunk which is now expanded to diaper area.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. On 14-MAY-2014, the patient was vaccinated with VARIVAX (Merck) 1350 U Vial (lot # and expiry date unknown), 0.5 ml, subcutaneous. The pharmacist reported that the patient, who was intended to receive ZOSTAVAX, inadvertently received a dose of with VARIVAX (Merck). It was reported that this was related to staff error. No adverse effects were reported. No product quality complaint. Outcome of the reported event was unknown. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAPHEPBIP, IPV, MMR, VARCEL
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: None.
Age: 18.0
Sex: F
Vaccine: ADEN_4_7, HEP, HEPA
Symptoms: Anaphylactic shock, Basophil percentage increased, Blood albumin normal, Blood creatine phosphokinase increased, Bronchitis
Clinical narrative: A report was received from an observational study. This is a Phase IV safety study using Adenovirus Type 4 and Type 7 Vaccine, Live, Oral. This report is based on data abstracted from a retrospective review. This report is a follow up report to the master case 353398USA. The subject, an 18 yr. old female was administered ADENOVIRUS TYPE 4 AND TYPE 7 LIVE VACCINE (Tablet, Oral) on 12-Jul-2012, batch: 34600039. On 12-Jul-2012, the patient experienced OTHER ANAPHYLACTIC SHOCK, NEC. The patient also had Acute Bronchitis on 13-Jul-2012 and received medication and an outpatient visit for this event. Lab tests: 13-Jul-2012, WBC: 18.62 mmol/L; 13-Jul-2012, Platelets: 439 mmol/L; 13-Jul-2012, Neutrophils: 82.7%; 13-Jul-2012, Lymphocytes: 8.9%; 13-Jul-2012, Monocytes: 8.1%; 13-Jul-2012, Absolute neutrophils: 15.4 mmol/L; 13-Jul-2012, Absolute monocytes: 1.5 mmol/L; 13-Jul-2012, Neutrophils segmented: 81%; 13-Jul-2012, Lymphocytes: 9%; 13-Jul-2012, Monocyte count: 7%; 13-Jul-2012, Basophils: 2%; 13-Jul-2012, Creatinine Kinase: 261 IU/L; 13-Jul-2012, Albumin: 4.9 g/dL; 16-Jul-2012, Lymphocytes: 21.6%; 16-Jul-2012, Monocytes: 10.9%; 16-Jul-2012, Absolute monocytes: 1.1 mmol/L. The outcome of the AEs were: OTHER ANAPHYLACTIC SHOCK, NEC: recovered/resolved. Action taken with suspect drugs: ADENOVIRUS VACCINE - Not applicable. The patient's medical history was not reported. The patient's concomitant medications included TETANUS VACCINE; DIPHTHERIA VACCINE; PERTUSSIS VACCINE (since 05-Jul-2012); MENINGOCOCCAL POLYSACCHARIDE (since 05-Jul-2012); POLIOMYELITIS VACCINE INACTIVATED (since 05-Jul-2012); HEPATITIS A VACCINE (since 12-Jul-2012); HEPATITIS B VACCINE (since 12-Jul-2012). The patient's past medication were unspecified. This case was considered serious based on the following criteria: (Other Serious (Important Medical Events)). Medical Monitor Assessment of Events: Causality between OTHER ANAPHYLACTIC SHOCK, NEC and ADENOVIRUS VACCINE is reported as Reasonable Possibility. "Patient got Prednisone and diphenhydramine for indication anaphylaxis in timeframe appropriate for possible relatedness but symptoms not specified". ICD-9 Code confirmed.
Age: 18.0
Sex: F
Vaccine: ADEN_4_7, HEP, HEPA
Symptoms: Lymphocyte percentage decreased, Monocyte count increased, Monocyte percentage increased, Neutrophil count increased, Neutrophil percentage increased
Clinical narrative: A report was received from an observational study. This is a Phase IV safety study using Adenovirus Type 4 and Type 7 Vaccine, Live, Oral. This report is based on data abstracted from a retrospective review. This report is a follow up report to the master case 353398USA. The subject, an 18 yr. old female was administered ADENOVIRUS TYPE 4 AND TYPE 7 LIVE VACCINE (Tablet, Oral) on 12-Jul-2012, batch: 34600039. On 12-Jul-2012, the patient experienced OTHER ANAPHYLACTIC SHOCK, NEC. The patient also had Acute Bronchitis on 13-Jul-2012 and received medication and an outpatient visit for this event. Lab tests: 13-Jul-2012, WBC: 18.62 mmol/L; 13-Jul-2012, Platelets: 439 mmol/L; 13-Jul-2012, Neutrophils: 82.7%; 13-Jul-2012, Lymphocytes: 8.9%; 13-Jul-2012, Monocytes: 8.1%; 13-Jul-2012, Absolute neutrophils: 15.4 mmol/L; 13-Jul-2012, Absolute monocytes: 1.5 mmol/L; 13-Jul-2012, Neutrophils segmented: 81%; 13-Jul-2012, Lymphocytes: 9%; 13-Jul-2012, Monocyte count: 7%; 13-Jul-2012, Basophils: 2%; 13-Jul-2012, Creatinine Kinase: 261 IU/L; 13-Jul-2012, Albumin: 4.9 g/dL; 16-Jul-2012, Lymphocytes: 21.6%; 16-Jul-2012, Monocytes: 10.9%; 16-Jul-2012, Absolute monocytes: 1.1 mmol/L. The outcome of the AEs were: OTHER ANAPHYLACTIC SHOCK, NEC: recovered/resolved. Action taken with suspect drugs: ADENOVIRUS VACCINE - Not applicable. The patient's medical history was not reported. The patient's concomitant medications included TETANUS VACCINE; DIPHTHERIA VACCINE; PERTUSSIS VACCINE (since 05-Jul-2012); MENINGOCOCCAL POLYSACCHARIDE (since 05-Jul-2012); POLIOMYELITIS VACCINE INACTIVATED (since 05-Jul-2012); HEPATITIS A VACCINE (since 12-Jul-2012); HEPATITIS B VACCINE (since 12-Jul-2012). The patient's past medication were unspecified. This case was considered serious based on the following criteria: (Other Serious (Important Medical Events)). Medical Monitor Assessment of Events: Causality between OTHER ANAPHYLACTIC SHOCK, NEC and ADENOVIRUS VACCINE is reported as Reasonable Possibility. "Patient got Prednisone and diphenhydramine for indication anaphylaxis in timeframe appropriate for possible relatedness but symptoms not specified". ICD-9 Code confirmed.
Age: 18.0
Sex: F
Vaccine: ADEN_4_7, HEP, HEPA
Symptoms: Platelet count increased, White blood cell count increased
Clinical narrative: A report was received from an observational study. This is a Phase IV safety study using Adenovirus Type 4 and Type 7 Vaccine, Live, Oral. This report is based on data abstracted from a retrospective review. This report is a follow up report to the master case 353398USA. The subject, an 18 yr. old female was administered ADENOVIRUS TYPE 4 AND TYPE 7 LIVE VACCINE (Tablet, Oral) on 12-Jul-2012, batch: 34600039. On 12-Jul-2012, the patient experienced OTHER ANAPHYLACTIC SHOCK, NEC. The patient also had Acute Bronchitis on 13-Jul-2012 and received medication and an outpatient visit for this event. Lab tests: 13-Jul-2012, WBC: 18.62 mmol/L; 13-Jul-2012, Platelets: 439 mmol/L; 13-Jul-2012, Neutrophils: 82.7%; 13-Jul-2012, Lymphocytes: 8.9%; 13-Jul-2012, Monocytes: 8.1%; 13-Jul-2012, Absolute neutrophils: 15.4 mmol/L; 13-Jul-2012, Absolute monocytes: 1.5 mmol/L; 13-Jul-2012, Neutrophils segmented: 81%; 13-Jul-2012, Lymphocytes: 9%; 13-Jul-2012, Monocyte count: 7%; 13-Jul-2012, Basophils: 2%; 13-Jul-2012, Creatinine Kinase: 261 IU/L; 13-Jul-2012, Albumin: 4.9 g/dL; 16-Jul-2012, Lymphocytes: 21.6%; 16-Jul-2012, Monocytes: 10.9%; 16-Jul-2012, Absolute monocytes: 1.1 mmol/L. The outcome of the AEs were: OTHER ANAPHYLACTIC SHOCK, NEC: recovered/resolved. Action taken with suspect drugs: ADENOVIRUS VACCINE - Not applicable. The patient's medical history was not reported. The patient's concomitant medications included TETANUS VACCINE; DIPHTHERIA VACCINE; PERTUSSIS VACCINE (since 05-Jul-2012); MENINGOCOCCAL POLYSACCHARIDE (since 05-Jul-2012); POLIOMYELITIS VACCINE INACTIVATED (since 05-Jul-2012); HEPATITIS A VACCINE (since 12-Jul-2012); HEPATITIS B VACCINE (since 12-Jul-2012). The patient's past medication were unspecified. This case was considered serious based on the following criteria: (Other Serious (Important Medical Events)). Medical Monitor Assessment of Events: Causality between OTHER ANAPHYLACTIC SHOCK, NEC and ADENOVIRUS VACCINE is reported as Reasonable Possibility. "Patient got Prednisone and diphenhydramine for indication anaphylaxis in timeframe appropriate for possible relatedness but symptoms not specified". ICD-9 Code confirmed.
Sex: M
Vaccine: ADEN_4_7, FLU3, IPV, TDAP
Symptoms: Anaphylactic shock, Antibody test positive, Blood cholesterol normal, Blood glucose normal, Blood group O
Clinical narrative: A report was received from an observational study. This is a Phase IV safety study using Adenovirus Type 4 and Type 7 Vaccine, Live, Oral. This report is based on data abstracted from a retrospective review. This report is a follow up report to the master case 353398USA. An adult male patient between the ages of 19-24 experienced OTHER ANAPHYLACTIC SHOCK, NEC from 18-Jan-2012 to 19-Jan-2012. The patient was administered ADENOVIRUS TYPE 4 AND TYPE 7 LIVE VACCINE (Tablet, Oral) batch: 34600017 on 13-Jan-2012. The event occurred on 18-Jan-2012. Treatment was given at an outpatient visit, the patient received medication. The severity and seriousness of this visit was not assessed per the patient's electronic health record. Event outcome was resolved on 19-Jan-2012. Treatment medication included: Prednisone 50mg PO, Epinephrine 0.3mg IM, BENADRYL 40mg IV, Albuterol 25mg INH, and SOLU-MEDROL 125mg IV. Lab tests 12-JAN-2012, Hepatitis B Virus AB: negative; 12-Jan-2012, Hepatitis A Virus AB: negative IU/L; 12-Jan-2012, ABO Group: O positive; 12-Jan-2012, varicella zoster AB: Immune; 12-Jan-2012, rubella virus AB: Immune; 12-Jan-2012, rubeola AB: Immune; 12-Jan-2012, G6 PD: 15.2 Unknown U/g; 12-Jan-2012, sickle cell screen: negative; 25-Jan-2012, glucose: 80 mg/dL; 25-Jan-2012, hemoglobin: 15.2 g/dL; 25-Jan-2012, hematocrit: 44.7%; 25-Jan-2012, cholesterol/HDL cholesterol: 3.6; 25-Jan-2012, cholesterol: 157 mg/dL; 25-Jan-2012, HDL: 44 mg/dL; 25-Jan-2012, LDL: 89 mg/dL; 25-Jan-2012, triglycerides: 119 mg/dL; 25-Jan-2012, hemolysis index: no hemolysis; 25-Jan-2012, Icterus index: 0; 25-Jan-2012, lipemia index: 47; 25-Jan-2012, urinalysis: negative, yellow, clear; 25-Jan-2012, Urobilinogen: 0.2 EU/dL; 25-Jan-2012, nitrate: negative; 25-Jan-2012, leukocyte esterase: negative; 25-Jan-2012, specific gravity: 1.020; 25-Jan-2012, pH: 6.5. The outcome of the AEs were: OTHER ANAPHYLACTIC SHOCK, NEC: recovered/resolved. Action taken with suspect drugs: Not applicable. The patient's medical history was not reported. The patient's concomitant medication included INFLUENZA VACCINE (since 13-Jan-2012); TDAP (since 13-Jan-2012); IPV (since 13-Jan-2012); MENINGOCOCCAL POLYSACCHARIDE (since 18-Jan-2012); HEPATITIS A VACCINE W/HEPATITIS B VACCINE (since 18-Jan-2012); RANITIDINE (Oral, since 18-Jan-2012); PARACETAMOL (Oral, since 20-Jan-2012, until 19-Jan-2013; since 08-Feb-2012, until 18-Feb-2012, for PAIN); Ibuprofen (Oral, since 08-Feb-2012, until 09-Mar-2012, for PAIN). The patient's past medication were unspecified. The medical monitor's causality assessment: The medical monitor assessed the causality between OTHER ANAPHYLACTIC SHOCK, NEC and ADENOVIRUS VACCINE as possible. This case was considered serious based on the following criteria: (Other Serious (Important Medical Events)).
Sex: M
Vaccine: ADEN_4_7, FLU3, IPV, TDAP
Symptoms: Blood triglycerides normal, Haematocrit normal, Haemoglobin normal, Hepatitis A antibody negative, Hepatitis B antibody negative
Clinical narrative: A report was received from an observational study. This is a Phase IV safety study using Adenovirus Type 4 and Type 7 Vaccine, Live, Oral. This report is based on data abstracted from a retrospective review. This report is a follow up report to the master case 353398USA. An adult male patient between the ages of 19-24 experienced OTHER ANAPHYLACTIC SHOCK, NEC from 18-Jan-2012 to 19-Jan-2012. The patient was administered ADENOVIRUS TYPE 4 AND TYPE 7 LIVE VACCINE (Tablet, Oral) batch: 34600017 on 13-Jan-2012. The event occurred on 18-Jan-2012. Treatment was given at an outpatient visit, the patient received medication. The severity and seriousness of this visit was not assessed per the patient's electronic health record. Event outcome was resolved on 19-Jan-2012. Treatment medication included: Prednisone 50mg PO, Epinephrine 0.3mg IM, BENADRYL 40mg IV, Albuterol 25mg INH, and SOLU-MEDROL 125mg IV. Lab tests 12-JAN-2012, Hepatitis B Virus AB: negative; 12-Jan-2012, Hepatitis A Virus AB: negative IU/L; 12-Jan-2012, ABO Group: O positive; 12-Jan-2012, varicella zoster AB: Immune; 12-Jan-2012, rubella virus AB: Immune; 12-Jan-2012, rubeola AB: Immune; 12-Jan-2012, G6 PD: 15.2 Unknown U/g; 12-Jan-2012, sickle cell screen: negative; 25-Jan-2012, glucose: 80 mg/dL; 25-Jan-2012, hemoglobin: 15.2 g/dL; 25-Jan-2012, hematocrit: 44.7%; 25-Jan-2012, cholesterol/HDL cholesterol: 3.6; 25-Jan-2012, cholesterol: 157 mg/dL; 25-Jan-2012, HDL: 44 mg/dL; 25-Jan-2012, LDL: 89 mg/dL; 25-Jan-2012, triglycerides: 119 mg/dL; 25-Jan-2012, hemolysis index: no hemolysis; 25-Jan-2012, Icterus index: 0; 25-Jan-2012, lipemia index: 47; 25-Jan-2012, urinalysis: negative, yellow, clear; 25-Jan-2012, Urobilinogen: 0.2 EU/dL; 25-Jan-2012, nitrate: negative; 25-Jan-2012, leukocyte esterase: negative; 25-Jan-2012, specific gravity: 1.020; 25-Jan-2012, pH: 6.5. The outcome of the AEs were: OTHER ANAPHYLACTIC SHOCK, NEC: recovered/resolved. Action taken with suspect drugs: Not applicable. The patient's medical history was not reported. The patient's concomitant medication included INFLUENZA VACCINE (since 13-Jan-2012); TDAP (since 13-Jan-2012); IPV (since 13-Jan-2012); MENINGOCOCCAL POLYSACCHARIDE (since 18-Jan-2012); HEPATITIS A VACCINE W/HEPATITIS B VACCINE (since 18-Jan-2012); RANITIDINE (Oral, since 18-Jan-2012); PARACETAMOL (Oral, since 20-Jan-2012, until 19-Jan-2013; since 08-Feb-2012, until 18-Feb-2012, for PAIN); Ibuprofen (Oral, since 08-Feb-2012, until 09-Mar-2012, for PAIN). The patient's past medication were unspecified. The medical monitor's causality assessment: The medical monitor assessed the causality between OTHER ANAPHYLACTIC SHOCK, NEC and ADENOVIRUS VACCINE as possible. This case was considered serious based on the following criteria: (Other Serious (Important Medical Events)).
Sex: M
Vaccine: ADEN_4_7, FLU3, IPV, TDAP
Symptoms: High density lipoprotein decreased, Icterus index, Laboratory test, Low density lipoprotein normal, Measles antibody positive
Clinical narrative: A report was received from an observational study. This is a Phase IV safety study using Adenovirus Type 4 and Type 7 Vaccine, Live, Oral. This report is based on data abstracted from a retrospective review. This report is a follow up report to the master case 353398USA. An adult male patient between the ages of 19-24 experienced OTHER ANAPHYLACTIC SHOCK, NEC from 18-Jan-2012 to 19-Jan-2012. The patient was administered ADENOVIRUS TYPE 4 AND TYPE 7 LIVE VACCINE (Tablet, Oral) batch: 34600017 on 13-Jan-2012. The event occurred on 18-Jan-2012. Treatment was given at an outpatient visit, the patient received medication. The severity and seriousness of this visit was not assessed per the patient's electronic health record. Event outcome was resolved on 19-Jan-2012. Treatment medication included: Prednisone 50mg PO, Epinephrine 0.3mg IM, BENADRYL 40mg IV, Albuterol 25mg INH, and SOLU-MEDROL 125mg IV. Lab tests 12-JAN-2012, Hepatitis B Virus AB: negative; 12-Jan-2012, Hepatitis A Virus AB: negative IU/L; 12-Jan-2012, ABO Group: O positive; 12-Jan-2012, varicella zoster AB: Immune; 12-Jan-2012, rubella virus AB: Immune; 12-Jan-2012, rubeola AB: Immune; 12-Jan-2012, G6 PD: 15.2 Unknown U/g; 12-Jan-2012, sickle cell screen: negative; 25-Jan-2012, glucose: 80 mg/dL; 25-Jan-2012, hemoglobin: 15.2 g/dL; 25-Jan-2012, hematocrit: 44.7%; 25-Jan-2012, cholesterol/HDL cholesterol: 3.6; 25-Jan-2012, cholesterol: 157 mg/dL; 25-Jan-2012, HDL: 44 mg/dL; 25-Jan-2012, LDL: 89 mg/dL; 25-Jan-2012, triglycerides: 119 mg/dL; 25-Jan-2012, hemolysis index: no hemolysis; 25-Jan-2012, Icterus index: 0; 25-Jan-2012, lipemia index: 47; 25-Jan-2012, urinalysis: negative, yellow, clear; 25-Jan-2012, Urobilinogen: 0.2 EU/dL; 25-Jan-2012, nitrate: negative; 25-Jan-2012, leukocyte esterase: negative; 25-Jan-2012, specific gravity: 1.020; 25-Jan-2012, pH: 6.5. The outcome of the AEs were: OTHER ANAPHYLACTIC SHOCK, NEC: recovered/resolved. Action taken with suspect drugs: Not applicable. The patient's medical history was not reported. The patient's concomitant medication included INFLUENZA VACCINE (since 13-Jan-2012); TDAP (since 13-Jan-2012); IPV (since 13-Jan-2012); MENINGOCOCCAL POLYSACCHARIDE (since 18-Jan-2012); HEPATITIS A VACCINE W/HEPATITIS B VACCINE (since 18-Jan-2012); RANITIDINE (Oral, since 18-Jan-2012); PARACETAMOL (Oral, since 20-Jan-2012, until 19-Jan-2013; since 08-Feb-2012, until 18-Feb-2012, for PAIN); Ibuprofen (Oral, since 08-Feb-2012, until 09-Mar-2012, for PAIN). The patient's past medication were unspecified. The medical monitor's causality assessment: The medical monitor assessed the causality between OTHER ANAPHYLACTIC SHOCK, NEC and ADENOVIRUS VACCINE as possible. This case was considered serious based on the following criteria: (Other Serious (Important Medical Events)).
Sex: M
Vaccine: ADEN_4_7, FLU3, IPV, TDAP
Symptoms: Nitrite urine absent, Red blood cell analysis normal, Rubella antibody positive, Specific gravity urine normal, Total cholesterol/HDL ratio decreased
Clinical narrative: A report was received from an observational study. This is a Phase IV safety study using Adenovirus Type 4 and Type 7 Vaccine, Live, Oral. This report is based on data abstracted from a retrospective review. This report is a follow up report to the master case 353398USA. An adult male patient between the ages of 19-24 experienced OTHER ANAPHYLACTIC SHOCK, NEC from 18-Jan-2012 to 19-Jan-2012. The patient was administered ADENOVIRUS TYPE 4 AND TYPE 7 LIVE VACCINE (Tablet, Oral) batch: 34600017 on 13-Jan-2012. The event occurred on 18-Jan-2012. Treatment was given at an outpatient visit, the patient received medication. The severity and seriousness of this visit was not assessed per the patient's electronic health record. Event outcome was resolved on 19-Jan-2012. Treatment medication included: Prednisone 50mg PO, Epinephrine 0.3mg IM, BENADRYL 40mg IV, Albuterol 25mg INH, and SOLU-MEDROL 125mg IV. Lab tests 12-JAN-2012, Hepatitis B Virus AB: negative; 12-Jan-2012, Hepatitis A Virus AB: negative IU/L; 12-Jan-2012, ABO Group: O positive; 12-Jan-2012, varicella zoster AB: Immune; 12-Jan-2012, rubella virus AB: Immune; 12-Jan-2012, rubeola AB: Immune; 12-Jan-2012, G6 PD: 15.2 Unknown U/g; 12-Jan-2012, sickle cell screen: negative; 25-Jan-2012, glucose: 80 mg/dL; 25-Jan-2012, hemoglobin: 15.2 g/dL; 25-Jan-2012, hematocrit: 44.7%; 25-Jan-2012, cholesterol/HDL cholesterol: 3.6; 25-Jan-2012, cholesterol: 157 mg/dL; 25-Jan-2012, HDL: 44 mg/dL; 25-Jan-2012, LDL: 89 mg/dL; 25-Jan-2012, triglycerides: 119 mg/dL; 25-Jan-2012, hemolysis index: no hemolysis; 25-Jan-2012, Icterus index: 0; 25-Jan-2012, lipemia index: 47; 25-Jan-2012, urinalysis: negative, yellow, clear; 25-Jan-2012, Urobilinogen: 0.2 EU/dL; 25-Jan-2012, nitrate: negative; 25-Jan-2012, leukocyte esterase: negative; 25-Jan-2012, specific gravity: 1.020; 25-Jan-2012, pH: 6.5. The outcome of the AEs were: OTHER ANAPHYLACTIC SHOCK, NEC: recovered/resolved. Action taken with suspect drugs: Not applicable. The patient's medical history was not reported. The patient's concomitant medication included INFLUENZA VACCINE (since 13-Jan-2012); TDAP (since 13-Jan-2012); IPV (since 13-Jan-2012); MENINGOCOCCAL POLYSACCHARIDE (since 18-Jan-2012); HEPATITIS A VACCINE W/HEPATITIS B VACCINE (since 18-Jan-2012); RANITIDINE (Oral, since 18-Jan-2012); PARACETAMOL (Oral, since 20-Jan-2012, until 19-Jan-2013; since 08-Feb-2012, until 18-Feb-2012, for PAIN); Ibuprofen (Oral, since 08-Feb-2012, until 09-Mar-2012, for PAIN). The patient's past medication were unspecified. The medical monitor's causality assessment: The medical monitor assessed the causality between OTHER ANAPHYLACTIC SHOCK, NEC and ADENOVIRUS VACCINE as possible. This case was considered serious based on the following criteria: (Other Serious (Important Medical Events)).
Sex: M
Vaccine: ADEN_4_7, FLU3, IPV, TDAP
Symptoms: Urine analysis normal, Urine leukocyte esterase, Urobilinogen urine, pH urine normal
Clinical narrative: A report was received from an observational study. This is a Phase IV safety study using Adenovirus Type 4 and Type 7 Vaccine, Live, Oral. This report is based on data abstracted from a retrospective review. This report is a follow up report to the master case 353398USA. An adult male patient between the ages of 19-24 experienced OTHER ANAPHYLACTIC SHOCK, NEC from 18-Jan-2012 to 19-Jan-2012. The patient was administered ADENOVIRUS TYPE 4 AND TYPE 7 LIVE VACCINE (Tablet, Oral) batch: 34600017 on 13-Jan-2012. The event occurred on 18-Jan-2012. Treatment was given at an outpatient visit, the patient received medication. The severity and seriousness of this visit was not assessed per the patient's electronic health record. Event outcome was resolved on 19-Jan-2012. Treatment medication included: Prednisone 50mg PO, Epinephrine 0.3mg IM, BENADRYL 40mg IV, Albuterol 25mg INH, and SOLU-MEDROL 125mg IV. Lab tests 12-JAN-2012, Hepatitis B Virus AB: negative; 12-Jan-2012, Hepatitis A Virus AB: negative IU/L; 12-Jan-2012, ABO Group: O positive; 12-Jan-2012, varicella zoster AB: Immune; 12-Jan-2012, rubella virus AB: Immune; 12-Jan-2012, rubeola AB: Immune; 12-Jan-2012, G6 PD: 15.2 Unknown U/g; 12-Jan-2012, sickle cell screen: negative; 25-Jan-2012, glucose: 80 mg/dL; 25-Jan-2012, hemoglobin: 15.2 g/dL; 25-Jan-2012, hematocrit: 44.7%; 25-Jan-2012, cholesterol/HDL cholesterol: 3.6; 25-Jan-2012, cholesterol: 157 mg/dL; 25-Jan-2012, HDL: 44 mg/dL; 25-Jan-2012, LDL: 89 mg/dL; 25-Jan-2012, triglycerides: 119 mg/dL; 25-Jan-2012, hemolysis index: no hemolysis; 25-Jan-2012, Icterus index: 0; 25-Jan-2012, lipemia index: 47; 25-Jan-2012, urinalysis: negative, yellow, clear; 25-Jan-2012, Urobilinogen: 0.2 EU/dL; 25-Jan-2012, nitrate: negative; 25-Jan-2012, leukocyte esterase: negative; 25-Jan-2012, specific gravity: 1.020; 25-Jan-2012, pH: 6.5. The outcome of the AEs were: OTHER ANAPHYLACTIC SHOCK, NEC: recovered/resolved. Action taken with suspect drugs: Not applicable. The patient's medical history was not reported. The patient's concomitant medication included INFLUENZA VACCINE (since 13-Jan-2012); TDAP (since 13-Jan-2012); IPV (since 13-Jan-2012); MENINGOCOCCAL POLYSACCHARIDE (since 18-Jan-2012); HEPATITIS A VACCINE W/HEPATITIS B VACCINE (since 18-Jan-2012); RANITIDINE (Oral, since 18-Jan-2012); PARACETAMOL (Oral, since 20-Jan-2012, until 19-Jan-2013; since 08-Feb-2012, until 18-Feb-2012, for PAIN); Ibuprofen (Oral, since 08-Feb-2012, until 09-Mar-2012, for PAIN). The patient's past medication were unspecified. The medical monitor's causality assessment: The medical monitor assessed the causality between OTHER ANAPHYLACTIC SHOCK, NEC and ADENOVIRUS VACCINE as possible. This case was considered serious based on the following criteria: (Other Serious (Important Medical Events)).
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to unspecified number of patients of unknown demographics. On an unknown date, an unspecified number of patients may have received ROTATEQ 0.5 millilitres suspension, orally (Lot# J002356, expiry date: not provided). The reporter reported that ROTATEQ were exposed to a lowest temperature of 32F (Fahrenheit) for a total of 1 hour over "four different occasions" and the improperly stored ROTATEQ were administered orally to an unspecified amount of patients. No adverse effect was reported. There was no product quality complaint involved. The case is linked to 1405USA004024, 1405USA011937, 1405USA011938, 1405USA009508, 1405USA011939, 1406USA009955, 1406USA009971, 1406USA009972, 1406USA009973, 1406USA009974, 1406USA009977 and 1406USA009978 (same reporter link). Additional information has been requested.