chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Dysphagia, Dysphonia, Dyspnoea, Endoscopy upper gastrointestinal tract abnormal, Endotracheal intubation
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 77 years old female patient of. The patient's pertinent medical history included type II diabetes, hypertension and history of breast cancer (remission). The patient had no drug reactions/Allergies. On 27-FEB-2014 the patient was vaccinated with a dose of ZOSTAVAX (lot#, dose, route not reported) at a local pharmacy. Concomitant therapies included aspirin (81mg), QUESTRAN, vitamin d (unspecified), hydrochlorothiazide, triamterene and verapamil. On 01-MAR-2014 the patient was presented to the Hospital with difficulty breathing - and diagnosed as having an allergic reaction to ZOSTAVAX. The patient was admitted, intubated and remained in the intensive care unit of the hospital for several days, total hospital time was "several" weeks. The nurse practitioner reported that patient was then transferred to an unspecified nursing facility for rehabilitation in which she was discharged on 24-APR-2014 and required physical therapy in the home. The nursing home diagnosis was anaphylaxis, chicken pox pneumonia, hypoxia, ischemic brain injury (TIA's) -which was ruled by CT Scan. The nurse practitioner reported that she saw patient in the office on 05-MAY-2014 and the patient presented with a weak, low voice; progressive problems swallowing, right eye drooping, use of a walker to walk. The nurse practitioner reported that she ordered a CT Scan looking for additional stroke symptoms, but the scan showed negative. Nurse practitioner then sent the patient to a gastrointestinal specialist who diagnosed patient with esophageal dysphagia, disturbance of speech and gastric reflux - which was diagnosed via an upper endoscopy. The nurse practitioner reported that on 13-MAY-2014, patient presented to her office and could not speak (patient was writing notes on paper). She stated that she no longer could speak, the dysphagia had gotten worse and continued to get progressively worse. Nurse practitioner reported that on 20-MAY-2014, she received a phone call from the patient's family member who stated the patient could not swallow, could not speak, could not close her mouth and could not open her eyes without holding them open with her fingers. The nurse practitioner sent patient to the emergency room at Medical Center, in which the patient has remained since. Patient has had a feeding tube inserted since the admission and has been diagnosed with Myasthenia gravis. At time of the report, outcome of these events was reported as not recovered. The reporter considered these events to be medically significant and life threatening. Additional information has been requested.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Eyelid function disorder, Eyelid ptosis, Gastrointestinal tube insertion, Gastrooesophageal reflux disease, Hypersensitivity
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 77 years old female patient of. The patient's pertinent medical history included type II diabetes, hypertension and history of breast cancer (remission). The patient had no drug reactions/Allergies. On 27-FEB-2014 the patient was vaccinated with a dose of ZOSTAVAX (lot#, dose, route not reported) at a local pharmacy. Concomitant therapies included aspirin (81mg), QUESTRAN, vitamin d (unspecified), hydrochlorothiazide, triamterene and verapamil. On 01-MAR-2014 the patient was presented to the Hospital with difficulty breathing - and diagnosed as having an allergic reaction to ZOSTAVAX. The patient was admitted, intubated and remained in the intensive care unit of the hospital for several days, total hospital time was "several" weeks. The nurse practitioner reported that patient was then transferred to an unspecified nursing facility for rehabilitation in which she was discharged on 24-APR-2014 and required physical therapy in the home. The nursing home diagnosis was anaphylaxis, chicken pox pneumonia, hypoxia, ischemic brain injury (TIA's) -which was ruled by CT Scan. The nurse practitioner reported that she saw patient in the office on 05-MAY-2014 and the patient presented with a weak, low voice; progressive problems swallowing, right eye drooping, use of a walker to walk. The nurse practitioner reported that she ordered a CT Scan looking for additional stroke symptoms, but the scan showed negative. Nurse practitioner then sent the patient to a gastrointestinal specialist who diagnosed patient with esophageal dysphagia, disturbance of speech and gastric reflux - which was diagnosed via an upper endoscopy. The nurse practitioner reported that on 13-MAY-2014, patient presented to her office and could not speak (patient was writing notes on paper). She stated that she no longer could speak, the dysphagia had gotten worse and continued to get progressively worse. Nurse practitioner reported that on 20-MAY-2014, she received a phone call from the patient's family member who stated the patient could not swallow, could not speak, could not close her mouth and could not open her eyes without holding them open with her fingers. The nurse practitioner sent patient to the emergency room at Medical Center, in which the patient has remained since. Patient has had a feeding tube inserted since the admission and has been diagnosed with Myasthenia gravis. At time of the report, outcome of these events was reported as not recovered. The reporter considered these events to be medically significant and life threatening. Additional information has been requested.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoxia, Intensive care, Myasthenia gravis, Speech disorder, Transient ischaemic attack
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 77 years old female patient of. The patient's pertinent medical history included type II diabetes, hypertension and history of breast cancer (remission). The patient had no drug reactions/Allergies. On 27-FEB-2014 the patient was vaccinated with a dose of ZOSTAVAX (lot#, dose, route not reported) at a local pharmacy. Concomitant therapies included aspirin (81mg), QUESTRAN, vitamin d (unspecified), hydrochlorothiazide, triamterene and verapamil. On 01-MAR-2014 the patient was presented to the Hospital with difficulty breathing - and diagnosed as having an allergic reaction to ZOSTAVAX. The patient was admitted, intubated and remained in the intensive care unit of the hospital for several days, total hospital time was "several" weeks. The nurse practitioner reported that patient was then transferred to an unspecified nursing facility for rehabilitation in which she was discharged on 24-APR-2014 and required physical therapy in the home. The nursing home diagnosis was anaphylaxis, chicken pox pneumonia, hypoxia, ischemic brain injury (TIA's) -which was ruled by CT Scan. The nurse practitioner reported that she saw patient in the office on 05-MAY-2014 and the patient presented with a weak, low voice; progressive problems swallowing, right eye drooping, use of a walker to walk. The nurse practitioner reported that she ordered a CT Scan looking for additional stroke symptoms, but the scan showed negative. Nurse practitioner then sent the patient to a gastrointestinal specialist who diagnosed patient with esophageal dysphagia, disturbance of speech and gastric reflux - which was diagnosed via an upper endoscopy. The nurse practitioner reported that on 13-MAY-2014, patient presented to her office and could not speak (patient was writing notes on paper). She stated that she no longer could speak, the dysphagia had gotten worse and continued to get progressively worse. Nurse practitioner reported that on 20-MAY-2014, she received a phone call from the patient's family member who stated the patient could not swallow, could not speak, could not close her mouth and could not open her eyes without holding them open with her fingers. The nurse practitioner sent patient to the emergency room at Medical Center, in which the patient has remained since. Patient has had a feeding tube inserted since the admission and has been diagnosed with Myasthenia gravis. At time of the report, outcome of these events was reported as not recovered. The reporter considered these events to be medically significant and life threatening. Additional information has been requested.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Varicella zoster pneumonia, Walking aid user
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 77 years old female patient of. The patient's pertinent medical history included type II diabetes, hypertension and history of breast cancer (remission). The patient had no drug reactions/Allergies. On 27-FEB-2014 the patient was vaccinated with a dose of ZOSTAVAX (lot#, dose, route not reported) at a local pharmacy. Concomitant therapies included aspirin (81mg), QUESTRAN, vitamin d (unspecified), hydrochlorothiazide, triamterene and verapamil. On 01-MAR-2014 the patient was presented to the Hospital with difficulty breathing - and diagnosed as having an allergic reaction to ZOSTAVAX. The patient was admitted, intubated and remained in the intensive care unit of the hospital for several days, total hospital time was "several" weeks. The nurse practitioner reported that patient was then transferred to an unspecified nursing facility for rehabilitation in which she was discharged on 24-APR-2014 and required physical therapy in the home. The nursing home diagnosis was anaphylaxis, chicken pox pneumonia, hypoxia, ischemic brain injury (TIA's) -which was ruled by CT Scan. The nurse practitioner reported that she saw patient in the office on 05-MAY-2014 and the patient presented with a weak, low voice; progressive problems swallowing, right eye drooping, use of a walker to walk. The nurse practitioner reported that she ordered a CT Scan looking for additional stroke symptoms, but the scan showed negative. Nurse practitioner then sent the patient to a gastrointestinal specialist who diagnosed patient with esophageal dysphagia, disturbance of speech and gastric reflux - which was diagnosed via an upper endoscopy. The nurse practitioner reported that on 13-MAY-2014, patient presented to her office and could not speak (patient was writing notes on paper). She stated that she no longer could speak, the dysphagia had gotten worse and continued to get progressively worse. Nurse practitioner reported that on 20-MAY-2014, she received a phone call from the patient's family member who stated the patient could not swallow, could not speak, could not close her mouth and could not open her eyes without holding them open with her fingers. The nurse practitioner sent patient to the emergency room at Medical Center, in which the patient has remained since. Patient has had a feeding tube inserted since the admission and has been diagnosed with Myasthenia gravis. At time of the report, outcome of these events was reported as not recovered. The reporter considered these events to be medically significant and life threatening. Additional information has been requested.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth, Tenderness
Clinical narrative: Raise surface, redness, warm, hard around the injection site otherwise tender, approx size of 40mm*60mm.
Sex: F
Vaccine: HPV4
Symptoms: Grand mal convulsion
Clinical narrative: This spontaneous report as received from a mother via company representative refers to a female child patient of unknown age. The field representative states a Local TV news show on 28-MAY-2014 10 PM referenced GARDASIL safety concerns. The representative investigated the information on 29-MAY-2014 and found an article on the website. The article includes adverse event information from a mother, reporting her two children (related sibling case 1406USA000201). On an unknown date the patient was vaccinated with GARDASIL (lot number and dose not reported). No other concomitant medications were reported. On an unknown date the patient experienced grand mal seizure (medically significant) after administration of GARDASIL. No product quality issue involved. The outcome of grand mal seizure is unknown. The causality of grand mal seizure is not reported. Additional information has been requested.
Age: 1.49
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pt had swelling, erythema and tenderness at site of injection.
Age: 1.52
Sex: M
Vaccine: DTPIHI, HIBV, RVX
Symptoms: Bladder catheterisation, Blood test, Chest X-ray, Convulsion, Pyrexia
Clinical narrative: Fever of 106.6 f. Seizure. Taken to ER twice. Follow up visit with pediatrician. Pediatrician stated that vaccines can not cause high fevers and seizures. ER doctors state vaccines do indeed cause high fevers which may result in seizures.
Age: 1.52
Sex: M
Vaccine: DTPIHI, HIBV, RVX
Symptoms: Streptococcus test, Urine analysis
Clinical narrative: Fever of 106.6 f. Seizure. Taken to ER twice. Follow up visit with pediatrician. Pediatrician stated that vaccines can not cause high fevers and seizures. ER doctors state vaccines do indeed cause high fevers which may result in seizures.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Cellulitis, Injection site erythema, Injection site induration, Injection site inflammation, Injection site pain
Clinical narrative: Received immunization on 05/29/14 to right and left thigh. 5/30/14 Redness to injection site - rt thigh. 5/31/14 Redness to injection site grew - developed red line - rt thigh. 6/1/14 Redness to injection site rt thigh worse - Developed another red line, hard, painful, inflamed. Treated for cellulitis with AUGMENTIN/ORAPRED.
Sex: M
Vaccine: HEPA
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a health care worker regarding male child of unknown age. Approximately on 02-JUN-2014 (also reported as yesterday), the patient was vaccinated with experienced VAQTA injection 0.5 ml (lot #, expiry date unknown), intramuscular (unspecified). No concomitant medication was reported. There was no product quality complaint. Outcome of the reported event was unknown. Additional information is not expected.
Age: 85.0
Sex: F
Vaccine: TDAP, VARZOS, TDAP, VARZOS
Symptoms: Asthenia, Dizziness, Lethargy, Mental status changes, Somnolence
Clinical narrative: Awoke late, lethargic, complaints of feeling light headed, AMS, substantial decreased strength in BLE, generalized weakness, transported to ER by paramedics, HTN, CVA ruled out.
Age: 85.0
Sex: F
Vaccine: TDAP, VARZOS, TDAP, VARZOS
Symptoms: Abasia, Asthenia, Blood pressure increased, Confusional state, Dizziness
Clinical narrative: Awoke late, lethargic, complaints of feeling light headed, AMS, substantial decreased strength in BLE, generalized weakness, transported to ER by paramedics, HTN, CVA ruled out.
Age: 85.0
Sex: F
Vaccine: TDAP, VARZOS, TDAP, VARZOS
Symptoms: Dyspnoea, Rash
Clinical narrative: Awoke late, lethargic, complaints of feeling light headed, AMS, substantial decreased strength in BLE, generalized weakness, transported to ER by paramedics, HTN, CVA ruled out.
Age: 24.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pain, Paraesthesia
Clinical narrative: Fever, body aches, tingling along spine, redness, swelling and pain at injection site.
Age: 24.0
Sex: M
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Fever, body aches, tingling along spine, redness, swelling and pain at injection site.
Age: 60.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Injection site reaction, Rash erythematous
Clinical narrative: Localized red rash like at injection site per pharm.
Age: 1.01
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Blister, Pruritus, Pyrexia, Skin lesion
Clinical narrative: Gave vaccines on Thursday, 2 1/2 days later, Saturday began breaking out w/vesicular lesions on abdomen. Fever of 101-102 for 2-3 days w increasing outbreak of lesions up to >200 over entire body (+) pruritis. On day 5 ousted lesions no fever, eating and drinking and playing well.
Age: 67.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Erythema, Injection site haemorrhage, Local swelling, Pain in extremity, Skin warm
Clinical narrative: (R) arm pain, erythema, swelling, warmth to touch (esp to forearm, noted ecchymosis to (R) upper arm.
Age: 67.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Ultrasound scan normal
Clinical narrative: (R) arm pain, erythema, swelling, warmth to touch (esp to forearm, noted ecchymosis to (R) upper arm.
Sex: U
Vaccine: PNC13
Symptoms: Purpura fulminans, Sepsis
Clinical narrative: This is a spontaneous report from a contactable physician. A patient of an unspecified age, ethnicity and gender received PREVNAR 13, via an unspecified route of administraiton, on 19May2014 at 0.5 ml, single. The patient medical history and concomitant medications were not reported. One day after having received PREVNAR 13, in May2014, the patient developed sepsis and purpura fulminans. The outcome of the reported events was unknown at the time of this report.
Sex: F
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker (medical assistant) refers to a patient of unknown age and gender. On 27-May-2014 the patient was vaccinated with an expired first dose of MMR II (dose and route unknown) lot # H009782, expiry date 15-MAY-2014. No adverse symptoms were reported. The healthcare worker stated that MMR II had no previous temperature excursions. 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 unspecified amount of patients of unknown age and gender. On an unknown date the patients were vaccinated with improperly stored doses of VARIVAX, 0.5 ml, subcutaneous (lot # not reported). On an unknown date the VARIVAX was exposed to a highest temperature of 11F for 2 hours total over four different excursions. There was no adverse effect reported. This case is linked to MARRS # 1406USA003453 (same reporter link). Additional information has been requested.
Age: 18.0
Sex: M
Vaccine: HEPA, HPV4, MEN
Symptoms: Clavicle fracture, Fall, Loss of consciousness
Clinical narrative: This spontaneous report as received from a consumer (field representative) refers to an 18 year old male patient, her son's friend. On approximately 28-MAY-2014 (reported as on either 28-MAY-2014 or 29-MAY-2014), the patient was vaccinated with two of the following three vaccines (the reporter could not determine which two they were): GARDASIL (dose, route and lot# not provided), Hepatitis A (manufacturer unknown) (dose, route and lot# not provided) and meningococcal vaccine (unspecified) (dose, route and lot# not provided). No concomitant medications were reported. The reproter reported that after receiving two of the vaccines (unspecified which two they were), the patient passed out and fell off the table in the doctor's office, then was sent to unspecified university hospital emergency room. The reporter stated that the patient broke his collar bone due to fall and had planned surgery for the collar bone on 06-JUN-2014. The outcome of events was reported as not recovered/resolved. The relatedness between the events and therapy with GARDASIL and Hepatitis A (manufacturer unknown) was not reported. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Condition aggravated, Headache, Incomplete course of vaccination
Clinical narrative: This spontaneous report as received from a physician via field representative refers to a 13 year old female patient with no drug reactions or allergies. The patient's medical history included a history of headaches. Approximately in May 2013 (reported as about one year ago) the patient was vaccinated with GARDASIL (lot number, expiration date were not reported) dose 1, therapy route reported as injection. Approximately in 2013 (exact date was not reported, reported as within 30 days of GARDASIL) the patient's mother followed up with the physician reported that her daughter experienced increase in headache intensity and frequency after receiving GARDASIL. No labs were performed. The patient was treated with TYLENOL and Ibuprofen. Therapy with GARDASIL was discontinued. The patient was administered only one dose. The outcome of increase in headache intensity and frequency was unknown. The relatedness between the event and GARDASIL was not reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacist via Company Representative refers to 2 patients of unknown age. On unknown dates the 2 patients were vaccinated with ZOSTAVAX (lot# not reported) (route, dose# and dosage not reported). On unknown dates the 2 patients developed shingles after receiving ZOSTAVAX. The outcome of shingles was unknown. Follow-up information was received from the pharmacist who stated that one patient was recently (date not specified in 2014) vaccinated with ZOSTAVAX and was currently taking shingles medication. The reporter did not have additional information. The outcome of the event was unknown. Causality assessment was not provided. This is one of several reports received from the same source. The other case was captured in MARRS# 1406USA000901. Additional information has been requested.
Sex: U
Vaccine: HEPA
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 VAQTA (lot# was not reported) which were improperly stored. No adverse events was reported. Additional information has been requested.
Age: 0.19
Sex: M
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a physician via company representative refers to approximately 9 week old male infant patient. No information provided regarding medical history and concurrent conditions. On 27-MAR-2014 the patient was vaccinated with VAQTA(dose, route, lot# not reported). No concomitant medications reported. The physician reported that the VAQTA was administered too early to an infant. No adverse events are being reported. Little patients details were given. The patient sought medical attention. The patient present status were reported as recovered. The vaccine was re introduced. The patient was not hospitalized due to experience. No death. Intervention to prevent serious criteria was not required. Product quality compliant was not involved. Additional information has been requested.
Age: 79.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Localized redness, swelling and itching at injection site.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to unspecified patients of unknown age. On 18-APR-2014 the patients were vaccinated subcutaneously with 0.5 ml of VARIVAX (dose and lot# not reported). It was reported that unknown number of doses of improperly stored VARIVAX has been administered to unspecified number of patients. The therapy of VARIVAX was exposed to two separate temperature excursions. 34F for 12 hours on 13-APR-2014 and 7.5F for 10 minutes on 02-JUL-2014. No adverse effects reported. The medical assistant called back on 03-JUN-2014 to report second excursion (which occurred on 02-JUN-2014) for VARIVAX and from this second inquiry, it was found that some doses of improperly stored VARIVAX were administered to patients since the initial temperature excursion on 18-APR-2014. Additional information has been requested.
Age: 29.0
Sex: U
Vaccine: HPV4, HPV4
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 29 years old patient (gender unknown). On 13-MAY-2014, the patient was vaccinated with GARDASIL injection, 0.5 ml (milliliter), intramuscularly. No concomitants were reported. The healthcare worker reported that a patient was accidentally administered GARDASIL instead of TDAP. No adverse effect reported. No product quality complaint (PQC) was involved. The outcome of was unknown. No further information was provided. Additional information has been requested.
Age: 29.0
Sex: U
Vaccine: HPV4, HPV4
Symptoms: Exposure during pregnancy, Incorrect dose administered, Wrong drug administered
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 29 years old patient (gender unknown). On 13-MAY-2014, the patient was vaccinated with GARDASIL injection, 0.5 ml (milliliter), intramuscularly. No concomitants were reported. The healthcare worker reported that a patient was accidentally administered GARDASIL instead of TDAP. No adverse effect reported. No product quality complaint (PQC) was involved. The outcome of was unknown. No further information was provided. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered
Clinical narrative: This spontaneous report as received from a pharmacist via RMPDC refers to a patient of unknown age and gender. On 31-MAY-2014, the patient was vaccinated with a dose of ZOSTAVAX, lot # J001698, expiration date 08-MAY-2014, (dose, frequency and route unknown). The patient's medical history, concomitant medications, and past drug history were unknown. This pharmacist reported that on 31-MAY-2014 the patient was given ZOSTAVAX that had expired on 08-MAY-2014. There was no laboratory data reported. As of 31-MAY-2014, it was unknown if the patient would receive another dose of ZOSTAVAX and the outcome of being given a dose that expired on 08-MAY-2014 was unknown. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report refers to unspecified number of patients of unknown demographics. On an unknown date the patient was vaccinated with VARIVAX (Merck), dose: 0.5ml (milliliters), subcutaneous injection. No concomitant medications were reported. Healthcare worker reported that 16 doses of VARIVAX (Merck), that had been improperly stored, were administered to patients since 29-MAY-2014, on unspecified dates. No adverse events were reported. There was no product quality complaint involved. The outcome of improperly stored vaccine administered was reported as unknown. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Adverse event, Walking aid user
Clinical narrative: This spontaneous report as received from a medical assistant refers to a male patient of unknown age. The medical assistant reported that on an unknown date the patient was vaccinated with a dose of ZOSTAVAX (lot#, dose, route, indication not reported). Concomitant medications were not reported. On an unknown date it was reported that "something effected him and now he walked with a cane". Outcome of the event was not provided. 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 registered nurse refers to multiple unspecified patients of unknown demographics. On an unkonwn date the patient were vaccinated with GARDASIL that were stored improperly for an unknown indication. No adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to multiple unspecified patients of unknown demographics. On an unknown date the patients were vaccinated with LIQUID PEDVAXHIB that were stored improperly for an unknown indication. No adverse effect reported. Additional information has been requested.
Age: 1.17
Sex: M
Vaccine: HEPA, HIBV, MMRV, PNC13, VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse via Medical Record refers to a currently 15 months old male patient with no known drug allergies (NKDA). On 04-MAR-2013, the patient was vaccinated with the first dose of PEDIARIX for DTP/aP; First dose of ACTHIB for Hib; First dose of PREVNAR 13 for PCV; First dose of ROTATEQ for Rotavirus. On 13-MAY-2013, the patient was vaccinated with the second dose of PEDIARIX for DTP/aP; Second dose of ACTHIB for Hib; Second dose of PREVNAR 13 for PCV; Second dose of ROTARIX for Rotavirus. On 12-JUL-2013, the patient was vaccinated with the third dose of PEDIARIX for DTP/aP; Third dose of ACTHIB for Hib; Third dose of PREVNAR 13 for PCV; Third dose of ROTARIX for Rotavirus. On 13-MAR-2014 at 12:04 pm the patient was vaccinated with the first dose of PROQUAD (lot # J015312, expiry date: 03-JUN-2015) (dose and route of administration not reported) which was stored improperly, exposed to 42F for 4 weeks. It was reported that the patient did not seek medical attention. On the same date, the patient was vaccinated concomitantly with the First dose of HAVRIX for HepA; Fourth dose of ACTHIB for Hib; Fourth dose of PREVNAR 13 for PCV and dose of VARIVAX (Merck) for Varicella (dose and lot# unspecified). This is one of several reports from the same source. Pediatric medical records were received and reviewed; no adverse experiences related to the prenatal exposure or to other Merck Products were identified. All available medical records will be provided upon request. Additional information is not expected.
Age: 1.03
Sex: M
Vaccine: FLU3, HEPA, MMRV, PNC13
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse via Medical Record refers to a 13 months old female patient with no known drug allergies (NKDA). The patient's current conditions included: gastro esophageal reflux disease (GERD) and umbilical hernia. On 17-MAR-2013, the patient was vaccinated with the first dose of hepatitis B virus vaccine (unspecified) for Hep B. On 22-MAY-2013, the patient was vaccinated with the first dose of PEDIARIX for DTP/aP; First dose of ACTHIB; First dose of PREVNAR 13 for PCV; First dose of ROTARIX for Rotavirus. On 19-JUL-2013, the patient was vaccinated with the second dose of DAPTACEL for DTP/aP; second dose of ACTHIB for Hib; Second dose of PREVNAR for PCV; Second dose of ROTARIX for Rotavirus. On 26-SEP-2013, the patient was vaccinated with the third dose of PEDIARIX for DTP/aP; third dose of ACTHIB; Third dose of PREVNAR 13 for PCV;On 17-JAN-2014, the patient was vaccinated with the First dose of FLUZONE-PF for influenza; Third dose of IPOL for Polio. On 24-MAR-2014 at 09:45 am, the patient was vaccinated with the first dose of PROQUAD (Merck) (lot # J015312, expiry date: 03-JUN-2013) (dose and route of administration not reported) which was stored improperly, exposed to 42F for 4 weeks. It was reported that the patient did not seek medical attention. On the same date, the patient was vaccinated with the first dose of HAVRIX for HepA; Second dose of FLUZONE-PF for influenza; Fourth dose of PREVNAR 13 for PCV and VARIVAX (Merck) for Varicella (dose and lot # not reported). On 28-APR-2014, the patient was vaccinated with PEDVAXHIB for Hib. This is one of several reports from the same source. Pediatric medical records were received and reviewed; no adverse experience related to the prenatal exposure or to other Merck Products. were identified. All available medical records will be provided upon request. Additional information is not expected.
Age: 25.0
Sex: F
Vaccine: ANTH
Symptoms: Hypoaesthesia, Injection site erythema, Injection site pain, Injection site swelling, Neck pain
Clinical narrative: APX 24 HOURS AFTER RECEIVING DOSE #2 OF ANTHRAX .5CC IM. GIVEN LEFT DELTOID, PT COMPLAINED OF PAIN UP TO NECK AND DOWN ARM TO FINGERTIPS. WITH SOME NUMBNESS TO FINGERTIPS. DELTOID SL SWOLLEN AND RED, NON HOT, NO FEVER, NO ENLARGED AXILLARY NODES. PT SELF TREATED WITH 400MG IBUPROFEN, HELPED A BIT.
Age: 25.0
Sex: F
Vaccine: ANTH
Symptoms: Pain in extremity
Clinical narrative: APX 24 HOURS AFTER RECEIVING DOSE #2 OF ANTHRAX .5CC IM. GIVEN LEFT DELTOID, PT COMPLAINED OF PAIN UP TO NECK AND DOWN ARM TO FINGERTIPS. WITH SOME NUMBNESS TO FINGERTIPS. DELTOID SL SWOLLEN AND RED, NON HOT, NO FEVER, NO ENLARGED AXILLARY NODES. PT SELF TREATED WITH 400MG IBUPROFEN, HELPED A BIT.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site swelling
Clinical narrative: Injection site area became very large and puffy and lots of itching. Started sometime last night (hours after injection).
Age: 24.0
Sex: F
Vaccine: HEP, HPV4
Symptoms: Corrective lens user, Disturbance in attention, Headache, Pain in extremity, Stress
Clinical narrative: Student returned to clinic on June 6, 2014, saw the nurse practitioner for headaches, losing focus, and soreness in left arm from HPV for 3 months ago. Per student pain worsened when she leans on her arm or if she lays on it.  No recent heavy lifting or trauma to arm.  Patient says she only does aerobic exercise. C/o that headache occurs 3-4 times per week for past 3 months. Helped by Advil. Patient got new glasses two months ago.   NP reports no swelling, bruising, redness, weakness, or muscle atrophy upon examination. Patient denies blurry vision, neck pain, nasal congestion, numbness, tingling or weakness. No MVA.  Patient reported that stress level has been increased lately b/c she had to take an exam and she isn't sure she passed, she has tried 3 times. Patient stated she doesn't drink much water and only eats 2 meals/day.  She has difficulty concentrating on her work and "took a friend's Concentra and it helped."  Patient wanted to know if she could get the medication.  Patient was referred to psychiatrist for evaluation of possible ADD or ADHD.  She is to increase water intake to at least 2 liters daily and eat 3 well balanced meals.  If arm pain persists advised to return to clinic and Xrays will be done to check for calcifications.
Age: 24.0
Sex: F
Vaccine: HEP, HPV4
Symptoms: Tenderness, Vision blurred
Clinical narrative: Student returned to clinic on June 6, 2014, saw the nurse practitioner for headaches, losing focus, and soreness in left arm from HPV for 3 months ago. Per student pain worsened when she leans on her arm or if she lays on it.  No recent heavy lifting or trauma to arm.  Patient says she only does aerobic exercise. C/o that headache occurs 3-4 times per week for past 3 months. Helped by Advil. Patient got new glasses two months ago.   NP reports no swelling, bruising, redness, weakness, or muscle atrophy upon examination. Patient denies blurry vision, neck pain, nasal congestion, numbness, tingling or weakness. No MVA.  Patient reported that stress level has been increased lately b/c she had to take an exam and she isn't sure she passed, she has tried 3 times. Patient stated she doesn't drink much water and only eats 2 meals/day.  She has difficulty concentrating on her work and "took a friend's Concentra and it helped."  Patient wanted to know if she could get the medication.  Patient was referred to psychiatrist for evaluation of possible ADD or ADHD.  She is to increase water intake to at least 2 liters daily and eat 3 well balanced meals.  If arm pain persists advised to return to clinic and Xrays will be done to check for calcifications.
Age: 43.0
Sex: M
Vaccine: TDAP
Symptoms: Dizziness, Fatigue, Pain in extremity, Pyrexia
Clinical narrative: Patient rec'd TDaP in the office with no problems reported.  24hours later he experienced extreme fatigue, low grade fever, dizziness, and mild arm pain that lasted 48 hours.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Joint range of motion decreased, Pain, Pain in extremity
Clinical narrative: PT with pain in arm. Decreased range of motion. No mention of redness, swelling, induration, numbness, weakness, fever within 24 of administration.  Pt with progressively worse pain with movement. Seen at convenient care center on 6/6/2014. Analgesics and warm compresses prescribed.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to an unspecified number of patients of unknown ages and gender. On an unknown dates the patients were administered unspecified number of doses of GARDASIL that were improperly stored. No adverse events were reported. This is one of several reports 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 pharmacist refers to an unspecified number of patients of unknown ages and gender. On an unknown dates the patients were administered unspecified number of doses of PNEUMOVAX23 that were improperly stored. No adverse events were reported. This is one of several reports from the same source. Additional information has been requested.
Age: 0.36
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Sudden infant death syndrome
Clinical narrative: SUID/SIDS.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Blood chloride normal, Blood creatinine normal, Blood potassium normal, Blood sodium normal, Blood urea normal
Clinical narrative: Pt had loose BM x several days prior to vax. 24-48 hr after vax she c/o myalgias and urticarial rash w/ localized edema. On exam she had urticarial lesions arms and fingers w/ mild edema (R) hand/foot.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Carbon dioxide normal, Culture stool positive, Escherichia test negative, Haemoglobin normal, Localised oedema
Clinical narrative: Pt had loose BM x several days prior to vax. 24-48 hr after vax she c/o myalgias and urticarial rash w/ localized edema. On exam she had urticarial lesions arms and fingers w/ mild edema (R) hand/foot.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Myalgia, Oedema peripheral, Platelet count normal, Protein urine present, Urticaria
Clinical narrative: Pt had loose BM x several days prior to vax. 24-48 hr after vax she c/o myalgias and urticarial rash w/ localized edema. On exam she had urticarial lesions arms and fingers w/ mild edema (R) hand/foot.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: White blood cell count increased
Clinical narrative: Pt had loose BM x several days prior to vax. 24-48 hr after vax she c/o myalgias and urticarial rash w/ localized edema. On exam she had urticarial lesions arms and fingers w/ mild edema (R) hand/foot.
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Product container issue
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a female patient of unknown age. On 08-MAY-2001, the patient was vaccinated with first dose of VARIVAX (0.5 ml, intramuscularly) (lot #, exp date: unknown). On an unknown date, the patient missed her second dose of VARIVAX because of a defective vial. No adverse effects were reported. Additional information is not expected.
Age: 12.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Incomplete course of vaccination, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report was received from a Nurse practitioner via a company representative refers to a 12 year old female patient. On 05-AUG-2013, the patient was vaccinated with GARDASIL dose 2. Concomitant therapy included TDAP. On 05-AUG-2013 (after the second dose), the patient experienced swelling and warmness at the injection site and swelling and warmness at the injection site. As a result of this adverse event, the parents of this patient did not allow the patient to complete the series of GARDASIL and the patient did not receive the 3rd shot of GARDASIL. The representative stated that, the patient received the 1st shot of GARDASIL on 28-MAY-2013. The representative then reported, the patient received the TDAP vaccine the same day as receiving the 2nd shot of GARDASIL. No intervention was initiated to prevent serious criteria as there was no seriousness criteria reported. No product quality complaint (PQC) was filed. On 05-AUG-2013, therapy with GARDASIL was discontinued. The outcome of swelling and warmness at the injection site and causality were not reported. Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a Nurse refers to a 1 year old patient of gender. On 30-MAY-2014, the patient was vaccinated with PROQUAD (Merck) for (dosing regimen unspecified). Other suspect therapies included on 30-MAY-2014, VARIVAX (Merck) (dosing regimen unspecified). On 30-MAY-2014, reporter reports that a 1 year old child was inadvertently administered PROQUAD (Merck) and VARIVAX (Merck) on the same day. No adverse effects reported. There was no product quality complaint involved. The outcome of PROQUAD (Merck) and VARIVAX (Merck) on the same day was unknown. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: VARCEL
Symptoms: Blister, Erythema, Oedema peripheral, Pain in extremity, Pruritus
Clinical narrative: Has Large red edematous area 100mm x 75mm to right arm with brownish-red edema with 4-5 vesicles in center this area is about 40mm.  Warm to touch, tender, itching painful.  No difficulty breathing or swallowing reported.
Age: 20.0
Sex: F
Vaccine: VARCEL
Symptoms: Skin warm, Tenderness
Clinical narrative: Has Large red edematous area 100mm x 75mm to right arm with brownish-red edema with 4-5 vesicles in center this area is about 40mm.  Warm to touch, tender, itching painful.  No difficulty breathing or swallowing reported.
Age: 58.0
Sex: M
Vaccine: VARCEL
Symptoms: Cough, Wrong drug administered
Clinical narrative: This spontaneous report as received from a physician regarding himself refers to a 58 year old male patient. No information about medical history, concurrent conditions and concomitant medications were reported. The reporter stated that he was vaccinated with VARIVAX lot K004419, expiration date 31-MAR-2016, dose 0.5 ml, route subcutaneous instead of ZOSTAVAX, and the next day developed a cough. The outcome of he was inadvertently administered VARIVAX instead of ZOSTAVAX is unknown and the outcome of the cough was reported as not recovered/not resolved. The patient sought medical attention. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified amount of patients of unknown age and gender. On an unknown date the patients were vaccinated with improperly stored doses of PROQUAD (Merck), 0.5 ml, subcutaneous (lot # not reported). On an unknown date the PROQUAD was exposed to a highest temperature of 11F for 2 hours total over four different excursions. There was no adverse effect reported. This case is linked to MARRS # 1406USA000368 (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 healthcare worker refers to a pediatric patient of unknown age and gender. On an unknown date in 2014 the patient was vaccinated with a dose of VARIVAX (0.5 ml, subcutaneously, LOT#, dose and expiration date not reported), which was exposed to -12C for 15 minutes between the dates of 22-APR-2014 and 08-MAY-2014. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a pediatric patient of unknown age and gender. On an unknown date in 2014 the patient was vaccinated with a dose of VARIVAX (0.5 ml, subcutaneously, LOT#, dose and expiration date not reported), which was exposed to -12C for 15 minutes between the dates of 22-APR-2014 and 08-MAY-2014 (VARIVAX stored improperly). No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a pediatric patient of unknown age and gender. On an unknown date in 2014 the patient was vaccinated with a dose of VARIVAX (0.5 ml, subcutaneously, LOT#, dose and expiration date not reported), which was exposed to -12C for 15 minutes between the dates of 22-APR-2014 and 08-MAY-2014 (VARIVAX stored improperly). No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Sex: M
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a pediatric patient of unknown age and gender. On an unknown date in 2014 the patient was vaccinated with a dose of VARIVAX (0.5 ml, subcutaneously, LOT#, dose and expiration date not reported), which was exposed to -12C for 15 minutes between the dates of 22-APR-2014 and 08-MAY-2014 (VARIVAX stored improperly). No adverse effects were reported. 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 healthcare worker refers to a pediatric patient of unknown age and gender. On an unknown date in 2014 the patient was vaccinated with a dose of VARIVAX (0.5 ml, subcutaneously, Lot#, dose  and expiration date not reported), which was exposed to -12C for 15 minutes between the dates of 22-APR-2014 and 08-MAY-2014 VARIVAX (stored improperly). No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: DTAP, IPV, MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse via Medical Record refers to a currently 4 years old patient with no known drug allergies (NKDA). On 17-MAR-2010, the patient was vaccinated with the first dose of HepB (unspecified) for HepB. On 06-MAY-2010, the patient was vaccinated with the first dose of PENTACEL for DTP/aP; Second dose of HepB (unspecified) for HepB; First dose of PREVNAR for PCV and First dose of ROTATEQ for Rotavirus. On 13-JUL-2010, the patient was vaccinated with the second dose of PENTACEL for DTP/aP; Second dose of PREVNAR 13 for PCV and Second dose of ROTATEQ for Rotavirus. On 20-SEP-2010, the patient was vaccinated with the third dose of PEDIARIX for DTP/aP; Third dose of ACTHIB for Hib; Third dose of PREVNAR 13 for PCV. On 20-DEC-2010, the patient was vaccinated with the first dose of FLUZONE for influenza. On 01-JUN-2011, the patient was vaccinated with the fourth dose of PENTACEL for DTP/aP; First dose of M-M-R II for Measles; Fourth dose of PREVNAR 13 for PCV. On 15-SEP-2011, the patient was vaccinated with the first dose of HAVRIX for HepA; Second dose of FLUZONE for influenza. On 21-MAR-2012, the patient was vaccinated with the second dose of HAVRIX for HepA. On 26-MAR-2014 at 02:25:15 pm, the patient was vaccinated with the Second dose of PROQUAD (Merck) (lot # J015312, expiry date: 03-JUN-2015) (dose and route of administration not reported) which was stored improperly, exposed to 42F for 4 weeks. It was reported that the patient did not seek medical attention. On the same date, the patient was vaccinated concomitantly with the Fifth dose of DAPTACEL for DTP/aP and the fifth dose of IPOL for Polio. This is one of several reports from the same source. Pediatric medical records were received and reviewed; no adverse experiences related to the prenatal exposure or to other Merck Products were identified. All available medical records will be provided upon request. Additional information is not expected.