chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: ADEN_4_7, HEPA, TDAP
Symptoms: Anaphylactic reaction, Human chorionic gonadotropin, Urine analysis 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. This report is regarding a 19-24 year old female patient who was administered ADENOVIRUS TYPE 4 AND TYPE 7 LIVE VACCINE (ORAL) batch: 34600018, on 11-Jan-2012. On the same day, the patient experienced ANAPHYLAXIS. The patient was treated at an outpatient visit with medication. The event resolved the same day. Treatment medications administered on 11-Jan-2012 included: ranitidine HCL 150mg QID, PO, stopped on 21-Jan-2012, diphenhydramine 25mg TID, PO stopped on 10-Feb-2012, cetrizine HCL 10mg daily, PO stopped on 11-Apr-2012, epinephrine 0.5mg daily, IM, stopped on 11-Jan-2012, BENADRYL 50mg daily, IV, stopped on 11-Jan-2012, SOLUMEDROL 125mg daily, IV stopped on 11-Jan-2012, oxygen 6 L/min daily nasal cannula, stopped on 11-Jan-2012. The patient's concomitant medication included INFLUENZA VACCINE (on 05-Jan-2012); MENINGOCOCCAL POLYSACCHARIDE (on 05-Jan-2012); IPV (on 05-Jan-2012); DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS (on 11-Jan-2012); HEPATITIS A VACCINE (on 11-Jan-2012). The maximum severity of the event was not assessed. Lab/diagnostic tests: 04-Jan-2012: HCG beta subunit less than 0.1 MIV/ml; hepatitis B virus surface AB: positive; hepatitis A virus surface AB: negative; varicella zoster virus AB: immune; rubella virus AB IgG: immune; rubeola virus AB IgG: immune; G6 PD 14.1 u/g hgb. 11-Jan-2012 HCG: inconclusive; urinalysis normal. The outcome of the AEs were: anaphylaxis: recovered/resolved. The patient's concomitant medication included INFLUENZA VACCINE (on 05-Jan-2012); MENINGOCOCCAL POLYSACCHARIDE; (on 05-Jan-2012); IPV; DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS (since 11-Jan-2012); HEPATITIS A VACCINE (since 11-Jan-2012). Action taken with suspect drug: ADENOVIRUS VACCINE - Not applicable. The patient's medical history was not reported. The patient's past medications were unspecified. This case was considered serious based on the following criteria: (Other Serious (Important Medical Events)). Per medical monitor: "Meds given for anaphylaxis same day as vaccines given." The medical monitor has assessed the event as possibly related to Adenovirus vaccine.
Sex: U
Vaccine: VARCEL
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. On an unknown date the patient was vaccinated with (Oka/Merck) VARIVAX (lot # unknown, strength, dosage and route unknown for unknown indication). The nurse reported that the patient was administered a dose of (Oka/Merck) VARIVAX that was improperly stored. No adverse effects reported. The outcome of the events was unknown. Additional information has been requested.
Sex: M
Vaccine: ADEN_4_7, FLU3, IPV, MNQ, TDAP
Symptoms: Anaphylactic shock, Blood creatine phosphokinase increased, C-reactive protein increased, Monocyte count increased, Neutrophil 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. This report is regarding a 19-24 year old Male patient who was administered ADENOVIRUS TYPE 4 AND TYPE 7 LIVE VACCINE (ORAL) batch: 34600017, on 26-Mar-2012. From 27-Mar-2012 to 06-Apr-2012, the patient was administered SULFAMETHOXAZOLE W/TRIMETHOPRIM 800/160 mg per tablet for a urinary tract infection. On 28-Mar-2012, the patient experienced OTHER ANAPHYLACTIC SHOCK, NEC and was hospitalized the same day. The patient was administered intravenous medications as treatment in the hospital. Lab tests: 27-Mar-2012, WBC: 14.5 mmol/L; 27-Mar-2012, Neutrophils: 85.8%; 27-Mar-2012, Absolute neutrophil count: 12.4 mmol/L; 27-Mar-2012, Monocytes: 0.9 mmol/L; 27-Mar-2012, Creatinine kinase: 378 IU/L; 27-Mar-2012, C-reactive protein: 4.30 mg/dL; 29-Mar-2012, C-reactive protein: 5.30 mg/dL; 29-Mar-2012, Neutrophils: 84.0%; 29-Mar-2012, Absolute neutrophil count: 8.9 mmol/L; 29-Mar-2012, ESR: 18 mm/hr. The outcome of the AEs were: OTHER ANAPHYLACTIC SHOCK, NEC: Unknown. Action taken with suspect drugs: ADENOVIRUS VACCINE - Not applicable; SULFAMETHOXAZOLE W/TRIMETHOPRIM - Dosage maintained. The patient's medical history was not reported. The patient's concomitant medication included INFLUENZA VACCINE (since 26-Mar-2012); DIPHTHERIA AND TETANUS TOXOIDS AND PERTUSSIS (since 26-Mar-2012); MENINGOCOCCAL POLYSACCHARIDE (since 26-Mar-2012); HEPATITIS A VACCINE (since 26-Mar-2012); POLIOMYELITIS VACCINE INACTIVATED (since 26-Mar-2012). The patient's past medication were unspecified. This case was considered serious based on the following criteria: (Hospitalization Required, Other Serious (Important Medical Events)). The Medical Monitor Assessment of Events: Causality of event OTHER ANAPHYLACTIC SHOCK, NEC in relation to Adenovirus is "No Reasonable Possibility". Event in relation to SULFAMETHOXAZOLE W/TRIMETHOPRIM is Probable. "Severity not assessed. Likely reaction to Sulfamethoxazole or Trimethoprim." ICD-9 code is confirmed.
Sex: M
Vaccine: ADEN_4_7, FLU3, IPV, MNQ, TDAP
Symptoms: Neutrophil percentage increased, Red blood cell sedimentation rate increased, Urinary tract infection, 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. This report is regarding a 19-24 year old Male patient who was administered ADENOVIRUS TYPE 4 AND TYPE 7 LIVE VACCINE (ORAL) batch: 34600017, on 26-Mar-2012. From 27-Mar-2012 to 06-Apr-2012, the patient was administered SULFAMETHOXAZOLE W/TRIMETHOPRIM 800/160 mg per tablet for a urinary tract infection. On 28-Mar-2012, the patient experienced OTHER ANAPHYLACTIC SHOCK, NEC and was hospitalized the same day. The patient was administered intravenous medications as treatment in the hospital. Lab tests: 27-Mar-2012, WBC: 14.5 mmol/L; 27-Mar-2012, Neutrophils: 85.8%; 27-Mar-2012, Absolute neutrophil count: 12.4 mmol/L; 27-Mar-2012, Monocytes: 0.9 mmol/L; 27-Mar-2012, Creatinine kinase: 378 IU/L; 27-Mar-2012, C-reactive protein: 4.30 mg/dL; 29-Mar-2012, C-reactive protein: 5.30 mg/dL; 29-Mar-2012, Neutrophils: 84.0%; 29-Mar-2012, Absolute neutrophil count: 8.9 mmol/L; 29-Mar-2012, ESR: 18 mm/hr. The outcome of the AEs were: OTHER ANAPHYLACTIC SHOCK, NEC: Unknown. Action taken with suspect drugs: ADENOVIRUS VACCINE - Not applicable; SULFAMETHOXAZOLE W/TRIMETHOPRIM - Dosage maintained. The patient's medical history was not reported. The patient's concomitant medication included INFLUENZA VACCINE (since 26-Mar-2012); DIPHTHERIA AND TETANUS TOXOIDS AND PERTUSSIS (since 26-Mar-2012); MENINGOCOCCAL POLYSACCHARIDE (since 26-Mar-2012); HEPATITIS A VACCINE (since 26-Mar-2012); POLIOMYELITIS VACCINE INACTIVATED (since 26-Mar-2012). The patient's past medication were unspecified. This case was considered serious based on the following criteria: (Hospitalization Required, Other Serious (Important Medical Events)). The Medical Monitor Assessment of Events: Causality of event OTHER ANAPHYLACTIC SHOCK, NEC in relation to Adenovirus is "No Reasonable Possibility". Event in relation to SULFAMETHOXAZOLE W/TRIMETHOPRIM is Probable. "Severity not assessed. Likely reaction to Sulfamethoxazole or Trimethoprim." ICD-9 code is confirmed.
Sex: U
Vaccine: VARCEL
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from registered nurse refers to a patient of unknown age and gender. No information provided regarding current conditions and medical history. On 14-JUN-2014 the patient was vaccinated with expired dose of VARIVAX (Merck) lot # H011553, expire date 11-JUN-2014, 0.5 ml, subcutaneous. No adverse effect reported. Product quality complaint 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 were vaccinated with VARIVAX (Merck) Injection, (strength, dose, frequency, route of administration and indication were not provided) that reached 18.5 F for 10 hours and 44 minutes. This range was outside of storage conditions in product insert; however, in house stability data can support those conditions mentioned above that the VARIVAX (Merck) was exposed to. No concomitant medication was reported. No adverse effects reported. No product quality complaint (PQC) was reported. The outcome of events was unknown. No further adverse event information was available. Follow up information (after previous telephone attempt to obtain follow up information which has been unsuccessful) has been received from a nurse concerning VARIVAX (Merck) temperature excursion and one patient of unspecified age and gender who was vaccinated with VARIVAX (Merck) (injection, strength, dose, frequency, route of administration and indication were not provided) (lot # J012817, exp date: 10-OCT-2015) that reached 18.5 F for 10 hours and 44 minutes. This is one of several reports received from the same source. Additional information has been requested.
Sex: M
Vaccine: ADEN_4_7, FLU3, IPV, MNQ, TDAP
Symptoms: Anaphylactic shock, Dermatitis
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 report concerns a 19-24 year old, male patient who was administered ADENOVIRUS TYPE 4 AND TYPE 7 LIVE VACCINE (Tablet, Oral) on 15-Jun-2012, batch: 34600029. The patient experienced OTHER ANAPHYLACTIC SHOCK, NEC on 20-Jun-2012. On 20-Jun-2012, patient received Epinephrine IM, Diphenhydramine IM and IV, Methylprednisolone IM for Anaphylactic Reaction. On 21-Jun-2012, the patient received Loratadine po, Methylprednisolone po, for Anaphylactic reaction and Hydrocortisone topical and Clobetasol propionate topical for dermatitis. Lab tests were not reported. 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 medication included INFLUENZA VACCINE (since 15-Jun-2012); DIPHTHERIA AND TETANUS TOXOIDS AND PERTUSSIS (since 15-Jun-2012); MENINGOCOCCAL POLYSACCHARIDE (since 15-Jun-2012); POLIOVIRUS VACCINE. 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: The medical monitor assessed the causality between OTHER ANAPHYLACTIC SHOCK, NEC and ADENOVIRUS VACCINE as having No Reasonable Possibility. "Event occurred 5 days after vaccine. Even though no other cause evident, a 5 day delay would be highly unlikely." ICD-9 event is confirmed.
Sex: F
Vaccine: HPV2
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report as received from a consumer refers to a female patient of unknown age (consumer's sister, no demographics were provided). On an unknown date, the patient received two of the three-dose regimen of GARDASIL (dose, route, lot# and expiration date not reported). The patient (on unspecified date) then received CERVARIX (dosage unspecified, manufacturer also reported as unknown) as the third dose of the three-dose regimen, which was other-than-indicated in the GARDASIL prescribing information. No adverse effects were reported. Additional information is not expected.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Nodule, Pruritus, Skin warm
Clinical narrative: This spontaneous report as received from a other health professional refers to an approximately 63 year old female patient. Pertinent medical history and drug reactions or allergies was reported as none. On 06-MAY-2014 the patient was vaccinated with ZOSTAVAX (dosing regimen unspecified). Concomitant medications were none. Approximately on an unknown date in MAY-2014 the patient experienced symptoms of itching, local warm hot nodule. Patient sought treatment with Physician on 08-MAY-2014. Treatment prescribed was ice and BENADRYL. There was no product quality complaint involved. Symptoms have resolved with no continuing issues. The outcome of symptoms of itching and local warm hot nodule was reported as resolved. Causality assessment was not provided. This case is linked to 1406USA004610 (same reporter link). Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to roughly 20 unspecified patients of unknown age. On an unknown date, roughly 20 unspecified were vaccinated with VARIVAX (strength, dose, frequency, route of administration and indication were not provided) that reached 18.5F 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 (after previous telephone attempt to obtain follow up information which has been unsuccessful) has been received from a 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 # J012817, exp date: 31-OCT-2015 also reported as 03-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: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker (medical assistant, M.A.) refers to an unknown number of patients of unknown age and gender. Pertinent medical history and drug reactions or allergies were not specified. On an unknown date, the patients were vaccinated with doses of GARDASIL (unknown dose in series, 0.5 ml, subcutaneously administered) that were stored at 34.7 Fahrenheit (F) for 36 hours. Affected lots included: lot number H021861, expiration date 09-OCT-2015; lot number H020901, expiration date 05-JUL-2015, lot number J013277, expiration date 06-AUG-2015 (reported as 05-AUG-2015) and lot number reported as J015375, expiration date 09-APR-2016. Concomitant medications were not specified. No adverse effects were reported. Lot number J015375 is an invalid lot number for GARDASIL. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker (medical assistant, M.A.) refers to an unknown number of patients of unknown age and gender. Pertinent medical history and drug reactions or allergies were not specified. On an unknown date, the patient's were vaccinated with doses of ROTATEQ 2 ml, oral, lot number K000471, expiration date 31-MAR-2015 and lot number J012518, expiration date 24-APR-2015, (unknown dose in series) that were stored at 34.7 Fahrenheit (F) for 36 hours. Concomitant medications were not specified. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Diverticular perforation, Small intestinal obstruction, Vitello-intestinal duct remnant, Volvulus
Clinical narrative: Patient had a history of esophageal atresia with fistula to trachea s/p repair at birth. 2 mo vaccines given 4/22/14. He was admitted 4/24/14 for small bowel obstruction, volvulus, ruptured Meckel's diverticulum.
Sex: U
Vaccine: VARCEL
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. On 02-JUN-2014 the patient was vaccinated with an expired dose of VARIVAX (Merck) batch #/ lot # H010559, Expiration Date 24-MAY-2014 (dose, frequency and route unknown). The expired dose of VARIVAX (Merck) was administered by an unspecified nurse. No adverse effect 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 (Oka/Merck) VARIVAX (injection, strength, dose, frequency, route of administration and indication were not provided) that reached 18.5 for 10 hours and 44 minutes. This range was outside of storage conditions in product insert; however, the reporter stated that their in house stability data could suppose those conditions mentioned above that the (Oka/Merck) VARIVAX was exposed to. No concomitant medication was reported. No adverse effects reported. No product quality complaint (PQC) was reported. The outcome of events was unknown. No further adverse information was available.   Follow up information (after previous telephone attempt to obtain follow-up information which has been unsuccessful) has been received from nurse concerning (Oka/Merck) VARIVAX temperature excursion and one patient (patient ID#136230) of unspecified age and gender who was vaccinated with (Oka/Merck) VARIVAX (injection, strength, dose, frequency, route of administration and indication were not provided) (lot # 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 (Merck) (injection, strength, dose, frequency, route of administration and indication were not provided) that reached 18.5 F for 10 hours and 44 minutes. This range was outside of storage conditions in product insert; however, the reporter stated that their in house stability data can support those conditions mentioned above that the VARIVAX (Merck) was exposed to. No concomitant medication was reported. No adverse effects reported. No product quality complaint (PQC) was reported. The outcome of events was unknown. No further adverse event information was available. Follow up information (after previous telephone attempt to obtain follow up information which has been unsuccessful) has been received from nurse concerning VARIVAX (Merck) temperature excursion and one patient of unspecified age and gender who was vaccinated with VARIVAX (Merck) (injection, strength, dose, frequency, route of administration and indication were not provided) (lot # J012384, exp date: 31-OCT-2015) that reached 18.5 F for 10 hours and 44 minutes. This is one of several reports 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 were vaccinated with VARIVAX (strength, dose, frequency, route of administration and indication were not provided) that reached 18.5F 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 (after previous telephone attempt to obtain follow up information which has been unsuccessful) has been received from a 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.
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin lesion
Clinical narrative: This spontaneous report as received from a nurse refers to a 85 year old female patient. On 16-JUN-2014 the patient was vaccinated with a dose of ZOSTAVAX (lot#, expiration date, dose, frequency and route unspecified). On an unknown date in June 2014 the patient developed lesions on her body, hands arms, scalp, neck and chest after receiving her ZOSTAVAX. The outcome of the event was reported as not recovered/not resolved. The patient sought medical attention via office visit. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No information about concurrent conditions and concomitant medications was reported. The reporter stated that the patient was inadvertently administered ROTATEQ (dose not reported) route oral, on 14-MAY-2014 which had expired on 27-MAR-2014 and no adverse effects reported. It was also reported that vaccine administration was supported as per stability memo. The outcome of events reported is unknown. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age. No information about concurrent conditions and concomitant medications were reported. The reporter stated that the patient was inadvertently administered ROTATEQ (dose not reported) route oral on 09-APR-2014, which had expired on 27-MAR-2014 and no adverse effects reported. It was also reported that vaccine administration was supported as per stability memo. The outcome of events reported is unknown. No product quality complaint was 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# J001252, expiry date: 20-SEP-2014). 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, 1406USA009970, 1406USA009971, 1406USA009973, 1406USA009974, 1406USA009977 and 1406USA009978 (same reporter link). Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to roughly 20 unspecified patients of unknown age. On an unknown date, roughly 20 unspecified patients were vaccinated with (Oka/Merck) VARIVAX (injection, strength, dose, frequency, route of administration and indication were not provided) that reached 18.5 for 10 hours and 44 minutes. This range was outside of storage conditions in product insert; however, the reporter stated that their in house stability data could suppose those conditions mentioned above that the (Oka/Merck) VARIVAX was exposed to. No concomitant medication was reported. No adverse effects reported. No product quality complaint (PQC) was reported. The outcome of events was unknown. No further adverse information was available.   Follow up information (after previous telephone attempt to obtain follow-up information which has been unsuccessful) has been received from nurse concerning (Oka/Merck) VARIVAX temperature excursion and one patient (patient ID# 45536) of unspecified age and gender who was vaccinated with (Oka/Merck) VARIVAX (injection, strength, dose, frequency, route of administration and indication were not provided) (lot # 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.
Age: 1.3
Sex: F
Vaccine: VARCEL
Symptoms: Blood immunoglobulin G, Blood immunoglobulin M, Varicella
Clinical narrative: This spontaneous report as received from a medical assistant via a company representative refers to a 15 month old female patient. On 15-APR-2014 the patient was vaccinated with VARIVAX (Merck), (lot# and strength unknown) 1 single shot, subcutaneous injection. On an unknown date after receiving the VARIVAX (Merck) the patient developed chickenpox. The patient sought unspecified medical attention. Immunoglobulin G (IGG) and immunoglobulin M (IGM) lab tests were performed but the result was not provided. The outcome of the event was reported as not recovered. The causality of the event and VARIVAX (Merck) was not provided. 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 milliliters suspension, orally (lot # J004875, expiry date: 17-OCT-2014). The reporter reported that ROTATEQ were exposed to a lowest temperature of 32F (Farenheit) 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.   This case is linked to 1405USA004025, 1405USA011937, 1405USA011938, 1405USA009508, 1405USA011939, 1406USA009955, 1406USA009970, 1406USA009972, 1406USA009973, 1406USA009974, 1406USA009977 and 1406USA009978 (same reporter link). Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: (L) arm swollen hot to touch and low grade fever.
Age: 0.47
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Urticaria
Clinical narrative: Hives
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Crying, Cyanosis, Staring
Clinical narrative: Infant received vaccines, cried for approx. a minute. Closed eyes, became slightly cyanotic around mouth, opened eyes with fixed stare. Infant placed in trendelenburg position and stimulated. Began crying in about 30 seconds, color returned to pink.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 70 year old male patient. The patient's current condition included diabetes, hypertension and hypercholesterolemia. The patient did not have any drug reactions or allergies. On an unknown date in 2012 (reported as 2 years ago) the patient was vaccinated with ZOSTAVAX (strength, dose, route of administration and lot number were not reported). Concomitant therapies included LIPITOR, niacin, TRICOR, metformin, hydrochlorothiazide (manufacturer unknown), lisinopril (manufacturer unknown), REQUIP and PLAVIX. On an unknown date the patient was diagnosed with shingles by his unspecified physician. The patient was treated with acyclovir. The patient had sought medical attention by office visit. There was no product quality complaint (PQC) involved. The outcome of shingles was reported as not recovered. Causality of the event was not provided. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Movement disorder, Pain in extremity, Sleep disorder
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 68 year old female patient with previous history of frozen shoulder, hyperlipidemia, osteoarthritis and asthma. There were no drug reactions/allergies. On 03-JUN-2014, the patient was vaccinated with a dose of PNEUMOVAX 23, lot # J011799, expiration date 09-FEB-2015, 0.5 ml, intramuscular. Concomitant therapies included PROAIR, LIPITOR and PLAVIX. On 03-JUN-2014, the patient an hour and half later after receiving PNEUMOVAX 23 experienced severe pain in the same arm, and had so much pain that evening that she could not sleep and could not lift her arm up the next day, on 04-JUN-2014. The medical assistant also noted that patient received BOOSTRIX (manufacturer unspecified) in the opposite arm at the same office visit. No treatment was given for adverse event. No lab diagnostics studies were performed. The patient contacted medical office to seek medical attention. The outcome of the events was not recovered. 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 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 milliliters suspension, orally (Lot# J008362, 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. Outcome of medication error was unknown. The case is linked to 1405USA004024, 1405USA011937, 1405USA011938, 1405USA009508, 1405USA011939, 1406USA009955, 1406USA009970, 1406USA009971, 1406USA009972, 1406USA009974, 1406USA009977, and 1406USA009978 (same reporter link). Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from an approximately 69 year old female consumer reporting on herself. Medical history and drug reactions or allergies were not reported. In September 2013 the patient was vaccinated with ZOSTAVAX 19400 plaque forming units (PFU) lot number, dosage, and route were not reported. Concomitant therapies included BENICAR. The consumer informed that in March 2014 the patient developed shingles on her face and forehead. The treatment given included cetirizine, tramadol, valacyclovir and methylprednisolone. There were not laboratories performed. The patient sought medical attention by an office visit. The outcome of the patients was not recovered. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to roughly 20 unspecified patients of unknown age. On an unknown date, roughly 20 unspecified were vaccinated with (Oka/Merck) VARIVAX injection (strength, dose, frequency, route of administration and indication were not provided) that reach 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 (Oka/Merck) VARIVAX was exposed to. No concomitant medication was reported. No adverse effects reported. No product quality (PQC) was reported. The outcome of events was unknown. No further adverse event information was available.   Follow up information (after previous telephone attempt to obtain follow up information which has been unsuccessful) has been received from a nurse concerning (Oka/Merck) VARIVAX temperature excursion and one patient (patient ID#100481) of unspecified age and gender who was vaccinated with (Oka/Merck) VARIVAX (strength, dose, frequency, route of administration and indication were not provided) (lot # J012817, exp date: 10-OCT-2015) that reached 18.5 F for 10 hours and 44 minutes.  This is one of several reports from the same source. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 66 year old female patient. On 03-JUN-2014 the patient was vaccinated with ZOSTAVAX lot # J013449, 0.65 ml, subcutaneous in the left arm. Dose number was not reported. Concomitant medication, pertinent medical history and drug reactions/allergies were unspecified by the reporter. In June 2014 (date not specified) the patient left arm at the injection site was red, hot to touch and raised area 3 inches by 2 inches. No rash. The pharmacist reported that the patient told her that the raised area at the injection site was getting bigger each day. Pharmacist reported that the patient was treating herself with Hydrocortisone cream. On 10-JUN-2014, the patient sought medical attention (pharmacist). No lab diagnostics studies performed. The patient would follow up with her primary health care provider for follow up. The outcome of her left arm at the injection site is red, injection site raised area 3 inches by 2 inches and injection site hot to touch was reported as not recovered/not resolved. Reporter causality assessment was not reported. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Skin papilloma
Clinical narrative: This spontaneous report was received from a physician via a company representative refers to a 14 year old female patient. On an unknown date the patient was vaccinated with her third dose of GARDASIL (dosing regimen unspecified). No concomitant medications were reported. The physician reported that 6 months after receiving her third dose of GARDASIL, an unspecified patient had warts on her hand. There was no product quality complaint involved. The outcome of had warts on the hand was unknown. Causality assessment was not provided. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to roughly 20 unspecified patients of unknown age. On an unknown date, roughly 20 unspecified patients were vaccinated with (Oka/Merck) VARIVAX (injection, strength, dose, frequency, route of administration and indication were not provided) that reached 18.5 for 10 hours and 44 minutes. This range was outside of storage conditions in product insert; however, the reporter stated that their in house stability data could suppose those conditions mentioned above that the (Oka/Merck) VARIVAX was exposed to. No concomitant medication was reported. No adverse effects reported. No product quality complaint (PQC) was reported. The outcome of events was unknown. No further adverse information was available.   Follow up information (after previous telephone attempt to obtain follow-up information which has been unsuccessful) has been received from nurse concerning (Oka/Merck) VARIVAX temperature excursion and one patient (patient ID#45982) of unspecified age and gender who was vaccinated with (Oka/Merck) VARIVAX (injection, strength, dose, frequency, route of administration and indication were not provided) (lot # 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: 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 milliliters suspension, orally (lot # J012523, expiry date: not provided). The reporter reported that ROTATEQ were exposed to a lowest temperature of 32F (Farenheit) 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, 1406USA008955, 1406USA009970, 1406USA009971, 1406USA009972, 1406USA009973, 1406USA009974, and 1406USA009977 (same reporter link). 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# J010966, expiry date: 20-MAR-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, 1406USA009974 and 1406USA009978 (same reporter link). 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 for 10 hours and 44 minutes. This range was outside of storage conditions in product insert; however, the reporter stated that their in house stability data could suppose those conditions mentioned above that the VARIVAX was exposed to. No concomitant medication was reported. No adverse effects reported. No product quality complaint (PQC) was reported. The outcome of events was unknown. No further adverse information was available. Follow up information (after previous telephone attempt to obtain follow-up information which has been unsuccessful) has been received from nurse concerning VARIVAX temperature excursion and one patient (patient ID# 152490) 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: M
Vaccine: VARZOS
Symptoms: Eye pain
Clinical narrative: This spontaneous report was received from a physician (who is also the patient) of approximately 60 years of age. No drug reactions or allergies were reported. The patient's current condition included hypertension. Approximately on an unknown date in 2008 (reported as 5 to 6 years ago) the patient was vaccinated with a dose of ZOSTAVAX 0.65 ml, subcutaneously (lot number and expiration dates were not reported) to prevent recurring episode of a mild case of shingles that he developed in an unspecified eye a year before (approximately in 2007) as well as three years before (approximately in 2005) he received the ZOSTAVAX. The symptoms of mild case of shingles that he developed in the past were repeated pain in an unspecified eye. Concomitant therapies included candesartan (manufacturer unknown) and an unspecified beta blocker. Approximately on an unknown date in 2010 (reported as a year or two later after he received ZOSTAVAX) the patient experienced pain in his unspecified eye but it was much milder. The patient did not receive any treatment for the event. There were no lab diagnostic studies performed. The patient did not seek any medical attention. There was no product quality complaint involved. The outcome of pain in his unspecified eye was unknown. The causality of the event was not provided. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a female patient of unknown age. No information regarding the patient's medical history was provided. On an unkown date in 2011 (reported as "three years ago") the patient was vaccinated with ZOSTAVAX. Dose and route were not provided. No concomitant medication was reported. Since the vaccination the patient had shingles twice (no dates provided) which she considered to be "rare". No outcome was reported. No causality assessment was provided. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a pharmacy technician on behalf of nurse refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with (Oka/Merck) VARIVAX (subcutaneous, dose was unknown) instead of (Oka/Merck) ZOSTAVAX. Pertinent medical history and concomitant medications were not reported. No adverse effects were reported. The outcome of the events was unknown. No additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to roughly 20 unspecified patients of unknown age. On an unknown date, roughly 20 unspecified patients were vaccinated with (Oka/Merck) VARIVAX (injection, strength, dose, frequency, route of administration and indication were not provided) that reached 18.5 for 10 hours and 44 minutes. This range was outside of storage conditions in product insert; however, the reporter stated that their in house stability data could suppose those conditions mentioned above that the (Oka/Merck) VARIVAX was exposed to. No concomitant medication was reported. No adverse effects reported. No product quality complaint (PQC) was reported. The outcome of events was unknown. No further adverse information was available.   Follow up information (after previous telephone attempt to obtain follow-up information which has been unsuccessful) has been received from nurse concerning (Oka/Merck) VARIVAX temperature excursion and one patient (patient ID#15152630) of unspecified age and gender who was vaccinated with (Oka/Merck) VARIVAX (injection, strength, dose, frequency, route of administration and indication were not provided) (lot # 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 (Oka/Merck) VARIVAX (injection, strength, dose, frequency, route of administration and indication were not provided) that reached 18.5 for 10 hours and 44 minutes. This range was outside of storage conditions in product insert; however, the reporter stated that their in house stability data could suppose those conditions mentioned above that the (Oka/Merck) VARIVAX was exposed to. No concomitant medication was reported. No adverse effects reported. No product quality complaint (PQC) was reported. The outcome of events was unknown. No further adverse information was available.   Follow up information (after previous telephone attempt to obtain follow-up information which has been unsuccessful) has been received from nurse concerning (Oka/Merck) VARIVAX temperature excursion and one patient (patient ID#70281) of unspecified age and gender who was vaccinated with (Oka/Merck) VARIVAX (injection, strength, dose, frequency, route of administration and indication were not provided) (lot # J012817, exp date: 10-OCT-2015) that reached 18.5 F for 10 hours and 44 minutes. This is one of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: This spontaneous report was received from a female patient of unknown age. No relevant medical history of the patient was reported. The patient was not pregnant. On 30-MAY-2014 the patient was vaccinated with ZOSTAVAX (strength, dose, route of administration, lot number and expiration date were not reported). No concomitant medications were reported.On 05-JUN-2014, the patient developed rash like bumpy area surrounding the injection site. The patient has no other symptoms. The patient had contacted her physician to verify if it was shingles. There was no information provided from the physicians conversation. The patient was not treated for the event. It was unspecified whether any lab diagnostic studies were performed. The patient had sought medical attention by contacting the office. There was no product quality complaint involved. The outcome of rash like bumpy area was reported as not recovered. The causality was not provided.  Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. On 12-JUN-2014 the patient was vaccinated with an expired ZOSTAVAX (lot # J000783, expiry date 30-APR-2014) (dose, route, indication not reported). No adverse events were reported. The patient outcome was unknown. Additional information is not expected.
Age: 16.0
Sex: M
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: This spontaneous report was received from a nurse via a company representative referring to a 16 year old male patient. Patient's medical history and drug allergies were unspecified. On 13-JUN-2014 the patient was vaccinated with GARDASIL, dose 1 intramuscular in the left deltoid muscle. No other concomitant therapies reported. Laboratory diagnostic tests were unspecified. On 13-JUN-2014 same day the patient fainted after 30 seconds. The patient was asked to lay down and after 10 minutes was fully recovered. No other symptoms were provided. There was no significant disability. There was no hospitalization. The event was not life-threatening. The outcome of fainted was reported as recovered/resolved. There was no PQC reported. Additional information has been requested.