chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash, Injection site reaction, Rash vesicular
Clinical narrative: Patient developed erythematous rash at the site with oozing vesicular rash in the center - at site of injection.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Feeling hot, Pruritus, Rash, Swelling
Clinical narrative: Rash, slightly raised swelling, warm, itching no pain fever. Slight erythema.
Age: 24.0
Sex: F
Vaccine: PPV
Symptoms: Skin warm, Swelling
Clinical narrative: Significant swelling and warm to touch 24 hours after administration.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a register nurse concerning a patient of unknown age and gender. Medica history and concurrent conditions were not reported. On 04-SEP-2014, the patient was vaccinated with a dose of (Oka/Merck) VARIVAX (dose number and  route were not reported), 0.5 ml. lot # K005182, expiration date 10-APR-2014 for vaccination. Co-suspect and concomitant therapies were not reported. The register nurse reported patient experienced 26 patients received doses of (Oka/Merck) VARIVAX (from lot # K005182, expiration date 10-APR-201 only) that were improperly stored. No adverse experiences reported. This is one (1) of twenty seven (27) reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a register nurse concerning a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 04-SEP-2014, the patient was vaccinated with a dose of (Merck) VARIVAX (dose number and route were not reported), 0.5 ml, lot # K005182, expiration date 10-APR-2014 for vaccination. Co-suspect and concomitant therapies were not reported. The register nurse reported patient experienced 26 patients received doses of (Merck) VARIVAX (from lot # K005182, expiration date 10-APR-2014 only) that were improperly stored. No adverse experiences reported. This is one (1) of twenty seven (27) reports from the same reporter. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site discolouration
Clinical narrative: Patient has a localized light purple area-about the size of a quarter at site of injection. Patient stated she had a headache on 12/12/14. Shot was administered (ZOSTAVAX) on 12/12/14.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a register nurse concerning a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 08-SEP-2014, the patient was vaccinated with a dose of (Oka/Merck) VARIVAX (dose number and route were not reported), 0.5 ml, lot # K005182, expiration date 10-APR-2014 for vaccination. Co-suspect and concomitant therapies were not reported. The register nurse reported patient experienced 26 patients received doses of (Oka/Merck) VARIVAX (from lot # K005182, expiration date 10-APR-201 only) that were improperly stored. No adverse effect reported for any of the patients. This is one (1) of twenty seven (27) reports from the same reporter.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a register nurse concerning a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 08-SEP-2014, the patient was vaccinated with a dose of (Oka/Merck) VARIVAX (dose number and route were not reported), 0.5 ml, lot # K005182, expiration date 10-APR-2014 for vaccination. Co-suspect and concomitant therapies were not reported. The register nurse reported patient experienced 26 patients received doses of (Oka/Merck) VARIVAX (from lot # K005182, expiration date 10-APR-201 only) that were improperly stored. No adverse effect reported for any of the patients. This is one (1) of twenty seven (27) reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a register nurse concerning a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 08-SEP-2014, the patient was vaccinated with a dose of VARIVAX (Merck) (dose number and route were not reported), 0.5 ml, lot # K005182, expiration date 10-APR-2014. Co-suspect and concomitant therapies were not reported. The register nurse reported patient experienced 26 patients received doses of VARIVAX (Merck) (from lot # K005182, expiration date 10-APR-201 only) that were improperly stored. No adverse effect reported for any of the patients. This is one (1) of twenty seven (27) reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. On an unknown date those patients were vaccinated with 10 doses of PEDVAXHIB (dose, units, route of administration, anatomical location, lot number were not reported) which had been improperly stored. No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a healthcare professional who was a quality control representative of a company refers to an unspecified number of patients of unknown age and gender. Doses of GARDASIL that were exposed to a temperature excursion on an unspecified date may had been administered to unspecified patients (lot#, dose, dose# and route not reported, indication default) on unspecified dates since the temperature excursion. He stated that some of the improperly stored doses were administered to some patients, but he was certain that the practices that administered the doses reported the administration to Merck to request revaccination information. He was not able to provide any healthcare provider information or case numbers, nor could he provide any additional information about these scenarios. He confirmed that he was aware that the administration of improperly-stored products to patients posed a safety risk to the patients. He did not know whether or not there had been any adverse effects. This is one of several reports received from the same source. Additional information is not expected as there was no consent for follow up contact.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a healthcare professional who was a quality control representative of a company refers to an unspecified number of patients of unknown age and gender. Doses of PNEUMOVAX that were exposed to a temperature excursion on an unspecified date may had been administered to unspecified patients (lot#, dose, dose# and route not reported) on unspecified dates since the temperature excursion. He stated that some of the improperly doses were administered to some patients, but he was certain that the practices that administered the doses reported the administration to Merck to request revaccination information. He was not able to provide any healthcare provider information or case numbers, nor could he provide any additional information about these scenarios. He confirmed that the was aware that the administration of improperly-stored products to patients posted a safety risk to the patients. He did not know whether or not there had been any adverse effects. This is one of several reports received from the same source. Additional information is not expected as there was not consent for follow up contact.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a healthcare professional who was a quality control representative of a company refers to an unspecified number of patients of unknown age and gender. Doses of VAQTA that were exposed to a temperature excursion on an unspecified date may had been administered to unspecified patients (lot#, dose, dose# and route not reported) on unspecified dates since the temperature excursion. He stated that some of the improperly stored doses were administered to some patients, but he was certain that the practices that administered the doses reported the administration to Merck to request revaccination information. He was not able to provide any healthcare provider information or case numbers, nor could he provide any additional information about these scenarios. He confirmed that he was aware that the administration of improperly-stored products to patients posed a safety risk to the patients. He did not know whether or not there had been any adverse effects. This is one of several reports received from the same source. Additional information is not expected as there was no consent for follow up contact.
Age: 44.0
Sex: M
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 44 year old male patient. On 12-DEC-2014 the patient was vaccinated with an expired dose of MMR II, human serum albumin (HSA) (lot # H020255, expiration date 08-NOV-2014, 0.5 ml, subcutaneously). Potency was supported. No adverse effects noted. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a healthcare professional who was a quality control representative of a company refers to an unspecified number of patients of unknown age and gender. Doses of RECOMBIVAX HB that were exposed to a temperature excursion on an unspecified date may had been administered to unspecified patients (lot#, dose, dose# and route not reported) on unspecified dates since the temperature excursion. He stated that some of the improperly stored doses were administered to some patients, but he was certain that the practices that administered the doses reported the administration to Merck to request revaccination information. He was not able to provide any healthcare provider information or case numbers, nor could he provide any additional information about these scenarios. He confirmed that the was aware that the administration of improperly-stored products to patients posted a safety risk to the patients. He did not know whether or not there had been any adverse effects. This is one of several reports received from the same source. Additional information is not expected as there was no consent for follow up contact.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a healthcare professional who was a quality control representative of a company refers to an unspecified number of patients of unknown age and gender. Doses of PEDVAXHIB that were exposed to a temperature excursion on an unspecified date may had been administered to unspecified patients (lot#, dose, dose# and route not reported) on unspecified dates since the temperature excursion. He stated that some of the improperly stored doses were administered to some patients, but he was certain that the practices that administered the doses reported the administration to Merck to request revaccination information. He was not able to provide any healthcare provider information or case numbers, nor could he provide any additional information about these scenarios. He confirmed that he was aware that the administration of improperly-stored products to patients posed a safety risk to the patients. He did not know whether or not there had been any adverse effects. This is one of several reports received from the same source. Additional information is not expected as there was no consent for follow up contact.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's relevant medical history, concomitant medications and past drug histories are unknown. On 09-DEC-2014 (also reported as "on unknown date") the patient was vaccinated with GARDASIL (dose, frequency and route of administration were not reported, lot # K005881, with expiration date 14-JUL-2007). On 09-DEC-2014 patient was given a GARDASIL that had been through a temperature excursion on this day and possibly a past temperature excursion. It was unknown if the GARDASIL was a first, second or third injection of the series. It was unknown if there was any relevant laboratory data. As of 09-DEC-2014 it was unknown if the patient will continue to receive GARDASIL and the outcome of giving the GARDASIL with a temperature excursion was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Hyperaesthesia, Rash
Clinical narrative: Patient c/o of rash on lower arm. Sensitive to touch, warm H2O, etc. Telephones her MD: Recommended BENADRYL Cream; F/U w/pt on 12/2/14 - condition still present but decreasing.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender. On 07-MAY-2014 the patient was vaccinated with (Merck) VARIVAX. Past medical history and concomitant medications were not reported. The physicians stated that an unspecified number of patients were vaccinated with a dose of improperly stored (Merck) VARIVAX, Lot #J005689 (expiration date: 07-MAY-2105). No adverse effects reported. No additional information to report. This is one of several reports received from the same reporter. This case is linked to 1411USA000763, 1411USA004435, 1411USA004436, 1411USA004438, 1411USA004439, 1411USA004440, 1411USA004694, 1411USA004695, 1411USA004696, 1411USA004698, 1411USA004700, 1411USA004701, and 1412USA006848. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender. On 09-May-2014 the patient was vaccianted with (Oka/Merck) VARIVAX. Past medical history and concomitnat medications were not reported. The physician stated that an unspecified number of patients were vaccinated with a dose of improperly stored (Oka/Merck) VARIVAX, Lot # Joo5689 (expiration date: 07-MAY-2015). No adverse effects reported. No additional information to report. This is one of several reprots received from the same reporter. THis case is linked to 1411USA000763, 1411USA004435, 1411USA004436, 1411USA004438, 1411USA004439, 1411USA004440, 1411USA004694, 1411USA004695, 1411USA004696, 1411USA004696, 1411USA004700, 1411USA004701, and 1411USA009185. Addtional ifnormation has been requested.
Age: 1.96
Sex: M
Vaccine: DTAP, HEPA, HIBV, PPV
Symptoms: Diarrhoea, Dyskinesia, Febrile convulsion, Pyrexia
Clinical narrative: Oct. 24, 2014 patient received vaccines. Oct. 25, 2014 he had fever as high as 103.8 (axillary) temp. Gave him TYLENOL, cool towels, liquids but could not get fever to go down. Whenever he went to sleep he began jerking/jumping (febrile seizures). He then started having diarrhea. Oct. 26, 2014 I called the on call nurse for advice and gave him MOTRIN and fever began to decrease some. Oct 27 I took him back to pediatrician.
Age: 27.0
Sex: F
Vaccine: ANTH, TYP
Symptoms: Erythema, Induration, Pain in extremity, Skin warm
Clinical narrative: Redness, spreading on arm, hard, hotness, a little painful. R arm.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to unknown number of patients of unknown age and gender. The nurse reported that an unknown number of doses of PROQUAD (Merck) (dose, lot# and route not reported) that were improperly stored (outside of the range specified in the prescribing information) might have been administered. PROQUAD (Merck) experienced freezer fluctuations of 7-9F and possibly temperatures of 14-15F for 24 hours. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 10.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative, Inappropriate schedule of drug administration, No therapeutic response
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of not responding to therapy in a 8-year-old female subject who was vaccinated with hepatitis B vaccine recombinant (Hepatitis B vaccine, manufacturer unspecified). On 2 March 2001, 2 July 2001 and 2 May 2003, the subject received 1st dose, 2nd dose and 3rd dose of Hepatitis B vaccine (unknown). The 2nd dose and the 3rd dose were given too late, which led to an inappropriate schedule of vaccine administered. At an unspecified date, anti-HBS titers were tested and showed a result lower than 10 mlU/mL. The subject did not respond to therapy. Since at the time of reporting the subject was entering at the medical assist school, she presented to have single ENGERIX-B dose. Follow-up information received by a pharmacist (initial reporter) on 16 October 2014: The patient received a booster dose on 12 June 2014 and was instructed to get her titers retested after 20-30 days.
Age: 27.0
Sex: F
Vaccine: HPV2
Symptoms: Delivery, Exposure during pregnancy, No adverse event, Ultrasound antenatal screen normal
Clinical narrative: This prospective pregnancy case was reported by healthcare professional and described the occurrence of vaccine exposure during pregnancy in a 27-year-old female subject who was vaccinated with CERVARIX, (GlaxoSmithKline). The subject's past medical history included 2 previous pregnancies (1 pre-term (still birth) and 1 full-term (normal birth)). Historic medications included (Low dose minipill) ORTHO MICRONOR for contraception and concurrent medications included Pre-natal vitamins. Examination results included prenatal diagnostic tests on 18 March 2014 (fetal ultrasound). There was no evidence of a defect. On 25 June 2014, the subject received an unspecified dose of CERVARIX (0.5 ml, unknown route, left deltoid). Her last menstrual period as on 1 November 2013 and estimated date of delivery was on 8 August 2014. The subject was exposed to the vaccine at 33 weeks and 5 days gestation. No adverse event was reported. At the time of reporting, the pregnancy was still ongoing. Follow-up received on 16 October 2014: The pregnancy resulted in a live neonate with no apparent congenital anomaly. On 8th October 2014 after 40 weeks, the patient gave birth to a male neonate via vaginal delivery. The neonate weighed 3628 grams (8lbs) at birth. APGAR scores were 7, 8 and 9. The reporter considered the vaccine exposure during pregnancy to be not assessable to CERVARIX.
Age: 62.0
Sex: M
Vaccine: HEP
Symptoms: Drug administered to patient of inappropriate age, Wrong drug administered
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of vaccine underdose in a 51-year-old male patient who received ENGERIX B pediatric. Co-suspect products included ENGERIX B pediatric. On 16th April 2014, the patient received the 1st dose of ENGERIX B pediatric. On 16th May 2014, the patient received the 2nd dose of ENGERIX B pediatric. On an unknown date, an unknown time after receiving ENGERIX B pediatric and ENGERIX B pediatric, the patient experienced vaccine underdose, inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the vaccine underdose, inappropriate age at vaccine administration and wrong vaccine administered were unknown. It was unknown if the reporter considered the vaccine underdose, inappropriate age at vaccine administration and wrong vaccine administered to be related to ENGERIX B pediatric. Additional information received: Per HCP, adult patient received pediatric doses of ENGERIX B for dose #1 given 4/16/14 and Dose #2 given 5/16/14. HCP could not provide lot numbers or expiration for doses of ENGERIX B that were given.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Feeling hot, Headache, Injection site swelling, Paraesthesia
Clinical narrative: This case was reported by a consumer and described the occurrence of injection site swelling in a 54-year-old female patient who received DTaP vaccine. Concurrent medical conditions included penicillin allergy, iodine allergy. Concomitant products included Tuberculosis vaccine. On 16th October 2014 11:00, the patient received DTaP vaccine (subcutaneous). On 16th October 2014, 30 min after receiving DTaP vaccine, the patient experienced injection site swelling, feeling hot, tingling of extremity and headache. The patient was treated with hydrocodone, PARACETAMOL. On an unknown date, the outcome of the injection site swelling, feeling hot, tingling of extremity and headache were not recovered/not resolved. It was unknown if the reporter considered the injection site swelling, feeling hot, tingling of extremity and headache to be related to DTaP vaccine. Additional information received: The patient received Tdap vaccine subcutaneously in the left arm below the deltoid muscle. She experienced symptoms within 30 minutes of the administration. She reported it to doctor's office but she was not given any guidance. She called the hospital this morning and was told to ice it and to keep it elevated.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy
Clinical narrative: This prospective pregnancy case was reported by a healthcare professional and described the occurrence of vaccine exposure during pregnancy in a 28-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). The subject's medical history included 3 previous full-term pregnancies. On 21 May 2014, the subject received an unspecified dose of BOOSTRIX (intramuscular, administration site unknown). The last menstrual period was on 3 September 2013 and estimated date of delivery was on 23 June 2014. The subject was exposed to the vaccine during 3rd trimester. At the time of reporting, the pregnancy was ongoing. Follow-up information received on 09 July 2014: The pregnancy was not the result of a in-vitro fertilization. The subject was vaccinated when she was 35+2 weeks pregnant. The stop date provided on the source document was different than start date of vaccination. As the date provided was very close to the estimated date of delivery, it could correspond to the delivery date. Clarification has been requested. Follow-up information received on 05 August 2014:  Some of the subject's details were changed. The VAERS info were provided. Follow-up information received on 23 September 2014 from physician: On 28 Jun 2014, after 37 weeks gestation, the subject gave birth to a male live infant, by normal vaginal delivery. The infant had an Apgar score of [8-9], a weight of 4.207 kg.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a physician refers to a few unspecified patients of unknown demographics. On an unknown date all the patients were administered with ZOSTAVAX (dose, frequency, therapy route, lot # expiry date unspecified) for vaccination. On an unknown date all the patients were administered with ZOSTAVAX (dose,frequency, therapy route, lot #, expiry date unspecified) for vaccination. On an unknown date all the patients vaccinated with ZOSTAVAX developed shingles post vaccination. Outcome of the event was not reported. No product quality complaint (PQC) was reported. Causality assessment was not provided. Additional information has been requested.
Sex: M
Vaccine: HPV4
Symptoms: Extra dose administered, Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a male patient of unknown age. On 02-NOV-2010 the patient was vaccinated with the first dose of GARDASIL by an unspecified Pediatrician (intramuscular, lot#, dose and frequency unknown). On 10-JAN-2011 and on 16-MAR-2011, the patient was administered with the second and third dose of GARDASIL (lot#, dose and frequency unknown) (route: IM) respectively by an unspecified Pediatrician. The patient was given a fourth dose of GARDASIL on 21-OCT-2014. No adverse effects were reported. It was not specified the patient sought for medical attention. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender. Information about concurrent conditions, concomitant medication and medical history was not provided. On 10-DEC-2014 the patient was vaccinated with a dose of PEDVAXHIB (lot # K004541, expiry date 04-DEC-2016 (also reported as 13-OCT-2016), dose, route and frequency were not provided) post not supported temperature excursion. Patient didn't report any adverse effect. This is one of several reports received from the same source. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 71 year old female patient. Patient's pertinent medical history was not reported. Patient was reported to be allergic to penicillin. On 04-DEC-2014 the patient was vaccinated with ZOSTAVAX (dose, frequency, therapy route unspecified; lot # K008882, expiration date: September 2014). Concomitant medications were not reported. On 06-DEC-2014, the patient experienced injection site reaction described as red, swollen, itchy, burning and the size of a tennis ball. The patient sought medical attention. On 07-DEC-2014, patient visited emergency room and was treated with BENADRYL, TYLENOL and cold compress. Outcome of injection site reaction described as red, swollen, itchy, burning and the size of a tennis ball was reported as recovering. No product quality complaint (PQC) was reported. No insertion and removal related events (IRRE) were reported. Reporter Causality assessment was not provided. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Cellulitis, Erythema, Skin warm, Swelling
Clinical narrative: Case number PHHY2014US148797 is an initial spontaneous report received via the Vaccine Adverse Event Reporting System (VAERS reference number: 538407) website on 13 Nov 2014, and with a follow-up report received from Quality Assurance Department (reference number: 337699) on 18 Nov 2014, with the follow-up information received from Quality Assurance Department (reference number: 337699) on 11 Dec 2014. This report refers to an 11 years old male patient. His medical history was not reported and concomitant medications included BENADRYL. He was vaccinated with MENVEO (batch number: M14023 and expiry date: Jul 2015) intramuscularly in the right arm, GARDASIL (other manufacturer, batch number: J009788) intramuscularly in the left arm and BOOSTRIX (other manufacturer, batch number: L7J44) intramuscularly in the right arm; all vaccines administered on 29 Jul 2014. On 30 Jul 2014, he experienced swelling, redness and it was hot to touch and the diagnosis was cellulitis. He was treated with KEFLEX 500 mg thrice a day (TID) for a week. The final outcome was reported as complete recovery. The events were reported non-serious, but the events were upgraded as medically significant based on the information available on NVS-IME list and NVx key event list. The causality of the event was not reported. Based on the investigation performed, the QA department stated that, MENVEO vaccine (batch number: M14023) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Non-significant follow-up report received from the Quality Assurance Department (reference number: 337699) on 18 Nov 2014: Updated QA number. Follow-up information received from the Quality Assurance Department (reference number: 337699) on 11 Dec 2014: Updated MENVEO batch review report.
Age: 90.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Dyspnoea, Erythema, Headache, Nausea, Pain
Clinical narrative: This spontaneous report as received from a consumer (regarding herself) refers to a 90 year old female patient. Medical history was reported as none. Patient had unspecified drug allergies/drug reaction. On 21-OCT-2014, the patient was vaccinated with ZOSTAVAX (dose, lot number and route not reported). Concomitant therapies included CARTIA and LUMIGAN. On 22-OCT-2014 (next day), the patient experienced blurred vision, headache and loss of appetite and became disoriented. The patient sought medical attention and went to urgent care when she noticed that her arm was swollen from the shoulder to the wrist where she received the vaccination. The physicians in the urgent care diagnosed with infection (hospitalization) since getting the ZOSTAVAX vaccination. The patient was prescribed prednisone (manufacturer unknown) and an antibacterial medication (manufacturer and dose unknown) for infection and advised to go to the hospital emergency room. On an unspecified date of 2014, the patient was admitted to hospital. The patient stated that prednisone (manufacturer unknown) caused problems with her eyesight and caused her to develop diabetes (captured in MARRS# 1412USA006282). On an unspecified date, biopsy was done due to loss of vision (onset date and results of biopsy not provided). The patient's present status was reported as not recovered/not resolved. Causality was not reported. No product quality complaint (PQC) was reported. Upon internal review the event of loss of vision was determined to be medically significant. Additional information has been requested.
Age: 90.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Skin warm, Swelling, Tremor, Visual impairment
Clinical narrative: This spontaneous report as received from a consumer (regarding herself) refers to a 90 year old female patient. Medical history was reported as none. Patient had unspecified drug allergies/drug reaction. On 21-OCT-2014, the patient was vaccinated with ZOSTAVAX (dose, lot number and route not reported). Concomitant therapies included CARTIA and LUMIGAN. On 22-OCT-2014 (next day), the patient experienced blurred vision, headache and loss of appetite and became disoriented. The patient sought medical attention and went to urgent care when she noticed that her arm was swollen from the shoulder to the wrist where she received the vaccination. The physicians in the urgent care diagnosed with infection (hospitalization) since getting the ZOSTAVAX vaccination. The patient was prescribed prednisone (manufacturer unknown) and an antibacterial medication (manufacturer and dose unknown) for infection and advised to go to the hospital emergency room. On an unspecified date of 2014, the patient was admitted to hospital. The patient stated that prednisone (manufacturer unknown) caused problems with her eyesight and caused her to develop diabetes (captured in MARRS# 1412USA006282). On an unspecified date, biopsy was done due to loss of vision (onset date and results of biopsy not provided). The patient's present status was reported as not recovered/not resolved. Causality was not reported. No product quality complaint (PQC) was reported. Upon internal review the event of loss of vision was determined to be medically significant. Additional information has been requested.
Age: 90.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Biopsy, Blindness, Decreased appetite, Diabetes mellitus, Disorientation
Clinical narrative: This spontaneous report as received from a consumer (regarding herself) refers to a 90 year old female patient. Medical history was reported as none. Patient had unspecified drug allergies/drug reaction. On 21-OCT-2014, the patient was vaccinated with ZOSTAVAX (dose, lot number and route not reported). Concomitant therapies included CARTIA and LUMIGAN. On 22-OCT-2014 (next day), the patient experienced blurred vision, headache and loss of appetite and became disoriented. The patient sought medical attention and went to urgent care when she noticed that her arm was swollen from the shoulder to the wrist where she received the vaccination. The physicians in the urgent care diagnosed with infection (hospitalization) since getting the ZOSTAVAX vaccination. The patient was prescribed prednisone (manufacturer unknown) and an antibacterial medication (manufacturer and dose unknown) for infection and advised to go to the hospital emergency room. On an unspecified date of 2014, the patient was admitted to hospital. The patient stated that prednisone (manufacturer unknown) caused problems with her eyesight and caused her to develop diabetes (captured in MARRS# 1412USA006282). On an unspecified date, biopsy was done due to loss of vision (onset date and results of biopsy not provided). The patient's present status was reported as not recovered/not resolved. Causality was not reported. No product quality complaint (PQC) was reported. Upon internal review the event of loss of vision was determined to be medically significant. Additional information has been requested.
Age: 90.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Headache, Infection, Injection site swelling, Local swelling, Vision blurred
Clinical narrative: This spontaneous report as received from a consumer (regarding herself) refers to a 90 year old female patient. Medical history was reported as none. Patient had unspecified drug allergies/drug reaction. On 21-OCT-2014, the patient was vaccinated with ZOSTAVAX (dose, lot number and route not reported). Concomitant therapies included CARTIA and LUMIGAN. On 22-OCT-2014 (next day), the patient experienced blurred vision, headache and loss of appetite and became disoriented. The patient sought medical attention and went to urgent care when she noticed that her arm was swollen from the shoulder to the wrist where she received the vaccination. The physicians in the urgent care diagnosed with infection (hospitalization) since getting the ZOSTAVAX vaccination. The patient was prescribed prednisone (manufacturer unknown) and an antibacterial medication (manufacturer and dose unknown) for infection and advised to go to the hospital emergency room. On an unspecified date of 2014, the patient was admitted to hospital. The patient stated that prednisone (manufacturer unknown) caused problems with her eyesight and caused her to develop diabetes (captured in MARRS# 1412USA006282). On an unspecified date, biopsy was done due to loss of vision (onset date and results of biopsy not provided). The patient's present status was reported as not recovered/not resolved. Causality was not reported. No product quality complaint (PQC) was reported. Upon internal review the event of loss of vision was determined to be medically significant. Additional information has been requested.
Age: 0.34
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Intussusception
Clinical narrative: Intussusception (ileal), resection due to non-reduction on 12/2/14. Pt also had previous episode on 10/22/14 of vomiting x 6 and unusual fussiness that spontaneously resolved. ROTATEQ was given 9/18/14 and 11/18/14.
Age: 0.34
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Blood bicarbonate normal, Enema administration, Haematocrit decreased, Intestinal resection, Intussusception
Clinical narrative: Intussusception (ileal), resection due to non-reduction on 12/2/14. Pt also had previous episode on 10/22/14 of vomiting x 6 and unusual fussiness that spontaneously resolved. ROTATEQ was given 9/18/14 and 11/18/14.
Age: 0.34
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Irritability, Ultrasound abdomen abnormal, Vomiting, Weight decreased, White blood cell count increased
Clinical narrative: Intussusception (ileal), resection due to non-reduction on 12/2/14. Pt also had previous episode on 10/22/14 of vomiting x 6 and unusual fussiness that spontaneously resolved. ROTATEQ was given 9/18/14 and 11/18/14.
Age: 2.0
Sex: M
Vaccine: FLUX
Symptoms: Pyrexia
Clinical narrative: 102 fever+ medicated with Motrin and Tylenol.
Age: 9.0
Sex: M
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Fatigue, Gait disturbance, Muscular weakness, Nerve conduction studies
Clinical narrative: Calf pain x 3 days followed by weakness in proximal legs and arms, followed by fatigue, difficulty walking, difficulty with activities of daily living.  Physical therapy initiated.
Age: 9.0
Sex: M
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Calf pain x 3 days followed by weakness in proximal legs and arms, followed by fatigue, difficulty walking, difficulty with activities of daily living.  Physical therapy initiated.
Age: 35.0
Sex: M
Vaccine: MMR
Symptoms: Dermatitis psoriasiform, Injection site rash, Pruritus, Rash
Clinical narrative: Constant itching, rash breakout, with spots that looks similar to psoriasis lesions.  Breakout on the left side where the vaccine was administered.  Also areas in the face.
Age: 49.0
Sex: F
Vaccine: HEP
Symptoms: Pruritus generalised, Rash generalised
Clinical narrative: Patient stated, during recent visit with MD, that when she returned home at night she began experiencing generalized rashes and itchiness.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Blood test, Bone scan, Nerve conduction studies, Nuclear magnetic resonance imaging, Organ failure
Clinical narrative: Patient began complaining of aches and pains. They were unexplained and no injury found. By the September the pain became too much and her body began to shut down.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Pain, Ultrasound Doppler, Venogram, X-ray
Clinical narrative: Patient began complaining of aches and pains. They were unexplained and no injury found. By the September the pain became too much and her body began to shut down.
Age: 64.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Hyperhidrosis, Influenza like illness, Nausea, Nodule
Clinical narrative: Severe pain, severe chills, sweats, nausea, hand swollen, remains swollen today 12/16/2014 large knot, small knot still remains. Flu like symptoms.
Age: 64.0
Sex: F
Vaccine: PNC13
Symptoms: Pain, Peripheral swelling
Clinical narrative: Severe pain, severe chills, sweats, nausea, hand swollen, remains swollen today 12/16/2014 large knot, small knot still remains. Flu like symptoms.
Age: 82.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Cardio-respiratory arrest, Chills, Computerised tomogram, Condition aggravated
Clinical narrative: Initial unsolicited case received from a consumer, who is the patient's wife, on 10 December 2014. An 82 year old male patient, with a history of allergies to Sulfa and REGLAN, received an intramuscular left deltoid injection of FLUZONE (lot number UI189AE) on 02 October 2014. The patient had nasal drainage at the time of vaccination. Three hours after receiving the vaccine, the patient's right arm began shaking uncontrollably. His fingers were white, and he was weak and needed help to walk. He presented to the emergency department, where he was given fluids. The symptoms of shaking became worse, and progressed to "full body shaking". He underwent a CT scan and x-rays; results were not reported. He experienced chills and fever, and per the reporter had a possible lung infiltrate. He continued to have nasal drainage. He was treated with an antibiotic and admitted to the hospital, where he remained for 13 days. According to the reporter, the patient died from "respiratory cardiac conditions" on an unspecified date. Documents held by sender: None.
Age: 82.0
Sex: M
Vaccine: FLU3
Symptoms: Death, Gait disturbance, Pallor, Pyrexia, Rhinorrhoea
Clinical narrative: Initial unsolicited case received from a consumer, who is the patient's wife, on 10 December 2014. An 82 year old male patient, with a history of allergies to Sulfa and REGLAN, received an intramuscular left deltoid injection of FLUZONE (lot number UI189AE) on 02 October 2014. The patient had nasal drainage at the time of vaccination. Three hours after receiving the vaccine, the patient's right arm began shaking uncontrollably. His fingers were white, and he was weak and needed help to walk. He presented to the emergency department, where he was given fluids. The symptoms of shaking became worse, and progressed to "full body shaking". He underwent a CT scan and x-rays; results were not reported. He experienced chills and fever, and per the reporter had a possible lung infiltrate. He continued to have nasal drainage. He was treated with an antibiotic and admitted to the hospital, where he remained for 13 days. According to the reporter, the patient died from "respiratory cardiac conditions" on an unspecified date. Documents held by sender: None.
Age: 82.0
Sex: M
Vaccine: FLU3
Symptoms: Tremor, X-ray
Clinical narrative: Initial unsolicited case received from a consumer, who is the patient's wife, on 10 December 2014. An 82 year old male patient, with a history of allergies to Sulfa and REGLAN, received an intramuscular left deltoid injection of FLUZONE (lot number UI189AE) on 02 October 2014. The patient had nasal drainage at the time of vaccination. Three hours after receiving the vaccine, the patient's right arm began shaking uncontrollably. His fingers were white, and he was weak and needed help to walk. He presented to the emergency department, where he was given fluids. The symptoms of shaking became worse, and progressed to "full body shaking". He underwent a CT scan and x-rays; results were not reported. He experienced chills and fever, and per the reporter had a possible lung infiltrate. He continued to have nasal drainage. He was treated with an antibiotic and admitted to the hospital, where he remained for 13 days. According to the reporter, the patient died from "respiratory cardiac conditions" on an unspecified date. Documents held by sender: None.
Age: 46.0
Sex: M
Vaccine: TDAP
Symptoms: Discomfort, Headache, Nausea
Clinical narrative: Persistent left sided headache assoc. w/ nausea, left sided face discomfort.
Age: 67.0
Sex: M
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site pain, Injection site reaction, Local swelling, Myalgia
Clinical narrative: Shoulder and arm where shot administered was VERY sore and muscle ache increased over time.  Within 72 hours, unable to raise left arm without significant pain.  Approximately 3 weeks later, visited family doctor who prescribed short term steroid treatment.  This alleviated much of pain.  Doctor stated she noticed swelling in arm.  Reaction was NOT from improper administration of shot.  It has now been approximately 3 months and there is still pain and problems with raising arm, but it has noticeably lessened.  My wife received the same vaccine at the same time and had a similar reaction.
Age: 67.0
Sex: M
Vaccine: FLU4
Symptoms: Pain
Clinical narrative: Shoulder and arm where shot administered was VERY sore and muscle ache increased over time.  Within 72 hours, unable to raise left arm without significant pain.  Approximately 3 weeks later, visited family doctor who prescribed short term steroid treatment.  This alleviated much of pain.  Doctor stated she noticed swelling in arm.  Reaction was NOT from improper administration of shot.  It has now been approximately 3 months and there is still pain and problems with raising arm, but it has noticeably lessened.  My wife received the same vaccine at the same time and had a similar reaction.
Age: 82.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Pyrexia
Clinical narrative: Patient stated she had experienced chills and fever.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Feeling cold, Insomnia, Pain in extremity, Temperature difference of extremities
Clinical narrative: Feet got really hot and arms got really cold. She sleeps on her left side and her arm hurt so she couldn't sleep. Shivered and felt cold. Felt better by the morning.
Age: 11.0
Sex: F
Vaccine: FLUN4
Symptoms: Pyrexia
Clinical narrative: Patient and sister are identical twins. Patient did not experience symptoms as severe as sister, but her school sent her home today with a fever of 101 degrees.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: VIIth nerve paralysis
Clinical narrative: Bells Palsy dx pt 12/9/2014. Vaccine influenza 12/12/2014.
Age: 11.0
Sex: F
Vaccine: FLUN4
Symptoms: Activities of daily living impaired, Fatigue, Headache, Oropharyngeal pain, Pyrexia
Clinical narrative: My daughters both got the live flu vaccine mist on Saturday after gymnastics class. They started developing symptoms - headache, sore throat, fatigue, fever, Sunday. Patient has missed 2 days of school so far.
Age: 89.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site bruising
Clinical narrative: Patient reported on 11/26/14 that she had bruising along arm where immunization was given. She had consulted her Dr and was given a "sulfa" drug.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Pain, Pain in extremity, Tenderness
Clinical narrative: Lt. shoulder/arm pain/tenderness began one week after vaccine. No pain after injection was given. Treated with NORCO, FLEXERIL, ADVIL, heat. No relief. Hurts to raise arm from shoulder to elbow. Still pain today. Never had reaction to flu vaccine in the past.
Age: 60.0
Sex: M
Vaccine: FLU3
Symptoms: Electrocardiogram, Electromyogram, Muscular weakness, Musculoskeletal pain, Neck pain
Clinical narrative: Developed severe pain in left arm, left shoulder, and neck (lower left) leading to ER visit and various doctor visit. Ended up with extreme weakness to left arm which is still present. Caused Parsonage/Turner Syndrome (Brachial Neuritis).
Age: 60.0
Sex: M
Vaccine: FLU3
Symptoms: Neuralgic amyotrophy, Nuclear magnetic resonance imaging, Pain in extremity, Radiculitis brachial
Clinical narrative: Developed severe pain in left arm, left shoulder, and neck (lower left) leading to ER visit and various doctor visit. Ended up with extreme weakness to left arm which is still present. Caused Parsonage/Turner Syndrome (Brachial Neuritis).
Age: 41.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Swelling, warmth and redness.
Age: 2.0
Sex: M
Vaccine: FLU3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: Vaccine expired--no adverse reaction.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Feeling hot, Local swelling, Urticaria
Clinical narrative: Localized swelling, hives (arms and torso), redness and warmth. Pt. has received yearly for 10 years without problems.
Age: 12.0
Sex: F
Vaccine: FLUC3
Symptoms: No adverse event, Off label use
Clinical narrative: NO adverse effect, Adult dose (only labeled for patients >18 years old) given to 12 year old patient.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pain in extremity
Clinical narrative: Pt. reported by phone call that the arm she received the flu shot hurt with movement. She seen a doctor around the end of November and was given an anti-inflamatory medication per pt. She said it continued to hurt so the doctor is giving her a steroid next.
Age: 10.0
Sex: F
Vaccine: FLU3
Symptoms: Influenza, Influenza A virus test positive
Clinical narrative: Pt. developed influenza requiring Tamiflu.
Age: 32.0
Sex: M
Vaccine: MNQ, YF
Symptoms: Hypersensitivity, Injection site erythema, Injection site reaction, Injection site swelling, Urticaria
Clinical narrative: SWOLLEN, RED WELT LOCATED ON BACK OF LEFT ARM TRICEP. PT SEEN BY PROVIDER ON 12/16/14 AND DIAGNOSED AS LOCAL ALLERGIC REACTION.
Age: 56.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Body temperature increased, Erythema, Local swelling, Pain in extremity, Skin warm
Clinical narrative: Arm red, swollen, hot, painful, temperature 100.2 F.
Age: 16.0
Sex: M
Vaccine: FLU4, HIBV
Symptoms: Wrong drug administered
Clinical narrative: Administered HIB vaccine instead of Menactra.
Age: 11.0
Sex: M
Vaccine: FLU3, HIBV, HPV4, TDAP
Symptoms: Wrong drug administered
Clinical narrative: Wrong vaccination administered to client.