chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.13
Sex: M
Vaccine: RV1
Symptoms: Rotavirus infection, Rotavirus test positive, Vaccination failure
Clinical narrative: This case was reported by a healthcare professional (nurse) and described the occurrence of rotavirus in a 8-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). Concurrent vaccination included dtpa-polio-hib (non-gsk); non-GSK manufacturer; unknown; unknown given on 28 June 2012; hepatitis B vaccine recombinant; manufacturer unspecified; unknown; unknown given on 28 June 2012; pneumococcal vaccines (non-gsk); non-GSK manufacturer; unknown; unknown given on 28 June 2012. On 10 April 2012 and 28 June 2012 the subject received 1st dose and 2nd dose of ROTARIX (oral "regular dose"). On 29 October 2012, 4 months after vaccination with the 2nd dose of ROTARIX and 7 months after vaccination with the first dose of ROTARIX, the subject experienced rotavirus and vaccination failure. The subject had received 2 doses of ROTARIX and was diagnosed with rotavirus in the hospital on 29 October 2012. The subject was hospitalized for 48 hours and then released to outpatient care. Relevant test results included a stool culture obtained in the hospital and the result was positive for A rotavirus. At the time of reporting the events were unresolved. The healthcare professional (nurse) considered the events were unrelated to vaccination with ROTARIX. The nurse did not feel that the vaccine caused the infection. Follow up information received from nurse on 29 January 2013. A stool culture (rotaviral AG) was done in the hospital and the report was positive A rotavirus gastroenteritis. The nurse documented that there were no other causes of gastroenteritis present and there was no past medical history.
Age: 53.0
Sex: F
Vaccine: RAB
Symptoms: Anxiety, Flushing, Palpitations
Clinical narrative: A 53-year-old female patient with unknown medical history and no reported concomitant medications had received second dose of IMOVAX intramuscularly on 10 August 2012 (batch number unknown and anatomical site of administration was not reported). The patient had previously received first dose of IMOVAX on 07 August 2012 and also received IMOGAM on 07 August 2012 (batch number unknown, route and site of administration not reported). The patient was bitten by a stray cat on 04 August 2012 which was destroyed before testing. On 10 August 2012, the patient had an anxiety attack which started 12 hours after the dose an had severe racing heart and flushing and called it an anxiety attack. Laboratory investigation and corrective treatment was not reported. The event anxiety attack was lasted for 36 hours however the overall outcome was reported as not recovered. Follow up information received from a non-healthcare professional 02 January 2013; the patient had received other 3 doses of IMOVAX (lot number: unknown, route and anatomical site of administration were not reported) on unspecified dates. No further information was available at the time of this report. Documents held by send: None.
Age: 29.0
Sex: M
Vaccine: RV1
Symptoms: Accidental exposure to product, Iritis
Clinical narrative: This case was reported by a physician via sales representatives and described the occurrence of iritis in an 29-year-old male subject (nurse) who was exposed to ROTARIX during administration. In November 2012 the subject administered a dose of ROTARIX. In November 2012, less than one week after vaccination with ROTARIX, the subject experienced iritis. The subject (nurse) was administering ROTARIX to an infant. "After the infant was administered the vaccine, the infant spit up on the nurse and some of the saliva went into the nurse's eye". The nurse developed iritis "within a week" of exposure. At the time of reporting the outcome of the event was unspecified. The healthcare professional reported another case of ROTARIX. See cas A1028037A for details on the other case.
Sex: U
Vaccine: RV1
Symptoms: Infantile spitting up, Oral administration complication, Underdose
Clinical narrative: This case was reported by a physician via sales representative and described the occurrence of spitting up in an infant subject of unspecified gender who was vaccianated with ROTARIX (GlaxoSmithKline). In November 2012 the subject received a dose of ROTARIX lyophilized formulation (oral) and experienced underdose. In November 2012, within minutes "after vaccination" with ROTARIX lyophilized formulation, the subject experienced spitting up. At the time of reporting the outcome of the event was unspecified. The healthcare professional reported another case with ROTARIX. See case A102804A for details on the other case.
Sex: U
Vaccine: RV1
Symptoms: Vomiting
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of vomiting in an infant subject of unspecified gender who was vaccinated with ROTARIX (GlaxoSmithKline). On an unspecified date, within the past four years the subject received unspecified dose of ROTARIX (oral). At an unspecified time after vaccination with ROTARIX the subject experienced vomiting. The infant subject vomited after receiving a dose of ROTARIX. The healthcare professional did not have specific details about the vomiting incident because it occurred in the past. At the time of reporting the outcome of the vomiting was unspecified. The healthcare professional reported another case, please see A1025910A.
Age: 0.36
Sex: F
Vaccine: IPV, RV1
Symptoms: Diarrhoea
Clinical narrative: This case was reported by a physician and described the occurrence of diarrhea in a 4-month-old female who was vaccinated with ROTARIX. Concurrent vaccinated included poliomyelitis vaccine inactivated (non-gsk); non-GSK manufacturer; unknown; unknown given on 13 May 2013. Concurrent medications included ZANTAC and ORAJEL. On 13 May 2013 the subject received 1st dose of ROTARIS (1 ml, oral). On 14 May 2013, 1 day after vaccination with ROTARIX, the subject experienced diarrhea. A physician reported a 4-month old patient was vaccinated with ROTARIX and developed diarrhea. The subject had two episodes on 14 May 2013 and five episodes on 15 May 2013. At the time of reporting the event was unresolved.
Age: 0.16
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Crying, Oral administration complication, Underdose, Vomiting
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of vaccine underdose in a 2-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). Concurrent medical conditions included esophageal reflux and umbilical hernia. Concurrent vaccination included DTaP-IPV/HepB; GlaxoSmithKline; intramuscular; unknown given on 24 April 2013; Hib (non-gsk); non-GSK manufacturer; intramuscular; unknown given on 24 April 2013; pneumococcal vaccine (non-gsk); non-GSK manufacturer; intramuscular; unknown given on 24 April 2013. Concurrent medications included AXID and MYLICON. On 24 April 2013 the subject received 1st dose of ROTARIX (1 ml, oral) and experienced vaccine underdose. On 24 April 2013, within minutes of vaccination with ROTARIX, the subject experienced threw up. It was reported that the subject received ROTARIX successfully and concomitant vaccinations that were administered intramuscularly. The subject then cried which caused him to "spit up/throw up" the contents of his stomach. The immunization series was not discontinued or delayed. At the time of reporting the outcome of the event of threw up was unspecified. Follow up received from nurse on 28 May 2013. The nurse reported that the adverse event of threw up had resolved. The nurse did not feel that this adverse event was serious. The nurse documented that the event of "threw up" could have been associated with medical history or concurrent illness of gastroesophageal reflux disorder or "crying after vaccine administration (injections)." The nurse documented that the immunization series was not discontinued but was delayed. The nurse documented that the subject "received a repeat dose 9 days later" which was calculated to be administered on 3 May 2013 and symptoms did not recur following subsequent administration. The subject had not experienced any adverse events following previous vaccinations.
Sex: U
Vaccine: RV1
Symptoms: Diarrhoea, Vomiting
Clinical narrative: This case was reported by a healthcare professional (certified medical assistant) and described the occurrence of diarrhea  in a subject of unspecified age and gender who was vaccinated with ROTARIX. On an unspecified date the subject received 2nd dose of ROTARIX. At an unspecified time after vaccination with ROTARIX, the subject experienced diarrhea and vomiting. The subject did not experience these events after the first dose of ROTARIX. At the time of reporting the outcome of the events were unspecified. The healthcare professional considered the events were possibly related to vaccination with ROTARIX.
Age: 8.0
Sex: F
Vaccine: RAB
Symptoms: Arthralgia, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: This case is linked to case number 2012-06120 and 2012-06129. A 4-year-old female patient, who has medical history of any known allergies, and concomitant medications were not reported, received first dose of IMOGAM (batch number, route and site of administration not reported) and IMOVAX (batch number, route and site of administration not reported) on 10 August 2011. The patient received subsequent dose of IMOVAX on 13 August 2012, 17 August 2012, 24 August 2012 and 7 September 2012 in alternate arms. On 11 August 2012, the patient complained of redness, itching and swelling on the site of injection and also the tops of her ankles were hurting. Corrective medications were not reported. The patient had recovered on an unspecified date. List of documents held by sender: none
Sex: U
Vaccine: HPV4
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. On an unknown dates the patients were vaccinated with GARDASIL (lot#, expiration date, route and anatomical location unspecified). The registered nurse reported that GARDASIL was not use for the entire HPV vaccination series, due to they ordered the wrong vaccine CERVARIX, from vaccine for children. So some patients received one or two doses of GARDASIL and then, absorbed CERVARIX was used to complete the series. No adverse effects reported. The outcome of patients was unknown. Additional information is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered pharmacist concerning three patients of unknown demographics. On 09-SEP-2013, three unspecified patients were vaccinated with an expired dose of VARVIAX (Merck) (lot number and expiry date were reported as H016329 and 31-AUG-2013 respectively, dose and route unspecified). No concomitant therapy was reported. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse, who reported that on 12-AUG-2013, one patient of unknown age and gender received one dose of GARDASIL (lot # H016238, expiration date 11-APR-2015) (dose and route were not reported) exposed to 31F for 84 hours over the past two months, since approximately June 2013. Concomitant medications were not reported. No adverse effects reported. This case is linked to cases 1308USA010552, 1309USA004737, 1309USA004745, and 1309USA004746 via same reported link. 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 licensed practical nurse, who reported that on 13-AUG-2013, one patient of unknown age and gender received one dose of GARDASIL (lot # reported as J004197, expiration date 27-NOV-2015) (dose and route were not reported) exposed to 31F for 84 hours over the past two months, since approximately June 2013. Concomitant medications were not reported. No adverse effects reported. This case is linked to cases 1308USA010552, 1309USA004737, 1309USA004745, 1309USA004747 via same reported link. 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 licensed practical nurse, who reported that on 07-AUG-2013, one patient of unknown age and gender received one dose of GARDASIL (lot # reported as J004192, expiration date 27-NOV-2015) (dose and route were not reported) exposed to 31F for 84 hours over the past two months, since approximately June 2013. Concomitant medications were not reported. No adverse effects reported. This case is linked to cases 1308USA010552, 1309USA004745, 1309USA004746, and 1309USA004747 via same reported link. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Chest pain
Clinical narrative: This spontaneous report as received from a physician assistant refers to a female patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX. On an unknown date the patient experienced chest pain. No treatment was given. On an unknown date chest pain resolved. No other details were provided. Additional information is not expected.
Age: 1.07
Sex: F
Vaccine: HEPA, MMR, PNC, VARCEL, HEPA, MMR, PNC13, VARCEL
Symptoms: Rash generalised
Clinical narrative: Diffuse morbilliform rash. Occurred 3d after MMR and varicella and pneumococcal PSV13 and Hep A vaccine.
Age: 1.07
Sex: F
Vaccine: HEPA, MMR, PNC, VARCEL, HEPA, MMR, PNC13, VARCEL
Symptoms: Rash morbilliform
Clinical narrative: Diffuse morbilliform rash. Occurred 3d after MMR and varicella and pneumococcal PSV13 and Hep A vaccine.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Hypoaesthesia
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX. Indication, lot number, expiry date, route of administration and anatomical location were not reported. On an unknown date after the vaccination the patient experienced numbness (hospitalization). The outcome of numbness was unknown. The reporting pharmacist did not provide a causality statement. Follow up information has been received from the pharmacist concerning the 60 year old female patient. On 26-AUG-2013, the patient was vaccinated SC with a dose of ZOSTAVAX (lot # J003359, expire on 21-JUN-2014). On an unspecified date, it's reported that the patient experienced redness and swelling at the injection site. The patient was given treatment instructions to use ice on affected redness and swelling, around injection site. Additionally, if pain increased, it was reported, that the patient was to use over the counter ibuprofen. During the week of 02-SEP-2013, date unspecified. The pharmacist had spoken to the patient. The patient reported that redness and swelling had resolved. This is one of several reports received from the same source. It was linked to MARR# 1309USA005057. This report has been downgraded due to the pharmacist stated no hospitalization or numbness was experienced by the patient. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Hypoaesthesia, Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX. Indication, lot number, expiry date, route of administration and anatomical location were not reported. On an unknown date after the vaccination the patient experienced numbness (hospitalization). The outcome of numbness was unknown. The reporting pharmacist did not provide a causality statement. Follow up information has been received from the pharmacist concerning the 60 year old female patient. On 26-AUG-2013, the patient was vaccinated SC with a dose of ZOSTAVAX (lot # J003359, expire on 21-JUN-2014). On an unspecified date, it's reported that the patient experienced redness and swelling at the injection site. The patient was given treatment instructions to use ice on affected redness and swelling, around injection site. Additionally, if pain increased, it was reported, that the patient was to use over the counter ibuprofen. During the week of 02-SEP-2013, date unspecified. The pharmacist had spoken to the patient. The patient reported that redness and swelling had resolved. This is one of several reports received from the same source. It was linked to MARR# 1309USA005057. This report has been downgraded due to the pharmacist stated no hospitalization or numbness was experienced by the patient. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Erythema, Mass, Skin warm
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX. Indication, lot number, expiry date, route of administration and anatomical location were not reported. On an unknown date after the vaccination the patient experienced numbness (hospitalization). The outcome of numbness was unknown. The reporting pharmacist did not provide a causality statement. Follow up information has been received from the pharmacist concerning the 60 year old female patient. On 26-AUG-2013, the patient was vaccinated SC with a dose of ZOSTAVAX (lot # J003359, expire on 21-JUN-2014). On an unspecified date, it's reported that the patient experienced redness and swelling at the injection site. The patient was given treatment instructions to use ice on affected redness and swelling, around injection site. Additionally, if pain increased, it was reported, that the patient was to use over the counter ibuprofen. During the week of 02-SEP-2013, date unspecified. The pharmacist had spoken to the patient. The patient reported that redness and swelling had resolved. This is one of several reports received from the same source. It was linked to MARR# 1309USA005057. This report has been downgraded due to the pharmacist stated no hospitalization or numbness was experienced by the patient. Additional information has been requested.
Age: 58.0
Sex: F
Vaccine: FLU3, VARZOS, FLU3, VARZOS, FLU3, VARZOS, FLU3, VARZOS
Symptoms: Convulsion, Malaise
Clinical narrative: This spontaneous report was received from a consumer's husband refers to his 58 year old wife with penicillin allergy (patient develops hives), high blood pressure and hypothyroidism. On 29-AUG-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot#, expiry not reported) and FLUVIRIN at the same time. Concomitant therapies included simvastatin (manufacturer unknown). On 01-SEP-2013, the patient experienced seizure. Patient sought medical attention. The patient went to the emergency room at an unspecified hospital for 8 hours but was not admitted over night. Unspecified tests were performed on the patient that determined that the seizure was a result of receiving ZOSTAVAX. The outcome of seizure was reported as recovering. The reporter considered seizure to be related to ZOSTAVAX. Upon internal review the event seizure was considered to be medically significant. Additional information has been requested.
Age: 58.0
Sex: F
Vaccine: FLU3, VARZOS, FLU3, VARZOS, FLU3, VARZOS, FLU3, VARZOS
Symptoms: Convulsion, Laboratory test abnormal, Vaccination complication
Clinical narrative: This spontaneous report was received from a consumer's husband refers to his 58 year old wife with penicillin allergy (patient develops hives), high blood pressure and hypothyroidism. On 29-AUG-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot#, expiry not reported) and FLUVIRIN at the same time. Concomitant therapies included simvastatin (manufacturer unknown). On 01-SEP-2013, the patient experienced seizure. Patient sought medical attention. The patient went to the emergency room at an unspecified hospital for 8 hours but was not admitted over night. Unspecified tests were performed on the patient that determined that the seizure was a result of receiving ZOSTAVAX. The outcome of seizure was reported as recovering. The reporter considered seizure to be related to ZOSTAVAX. Upon internal review the event seizure was considered to be medically significant. Additional information has been requested.
Age: 58.0
Sex: F
Vaccine: FLU3, VARZOS, FLU3, VARZOS, FLU3, VARZOS, FLU3, VARZOS
Symptoms: Grand mal convulsion, Injection site erythema, Injection site pain, Injection site swelling, Nuclear magnetic resonance imaging
Clinical narrative: This spontaneous report was received from a consumer's husband refers to his 58 year old wife with penicillin allergy (patient develops hives), high blood pressure and hypothyroidism. On 29-AUG-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot#, expiry not reported) and FLUVIRIN at the same time. Concomitant therapies included simvastatin (manufacturer unknown). On 01-SEP-2013, the patient experienced seizure. Patient sought medical attention. The patient went to the emergency room at an unspecified hospital for 8 hours but was not admitted over night. Unspecified tests were performed on the patient that determined that the seizure was a result of receiving ZOSTAVAX. The outcome of seizure was reported as recovering. The reporter considered seizure to be related to ZOSTAVAX. Upon internal review the event seizure was considered to be medically significant. Additional information has been requested.
Age: 58.0
Sex: F
Vaccine: FLU3, VARZOS, FLU3, VARZOS, FLU3, VARZOS, FLU3, VARZOS
Symptoms: Scan brain
Clinical narrative: This spontaneous report was received from a consumer's husband refers to his 58 year old wife with penicillin allergy (patient develops hives), high blood pressure and hypothyroidism. On 29-AUG-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot#, expiry not reported) and FLUVIRIN at the same time. Concomitant therapies included simvastatin (manufacturer unknown). On 01-SEP-2013, the patient experienced seizure. Patient sought medical attention. The patient went to the emergency room at an unspecified hospital for 8 hours but was not admitted over night. Unspecified tests were performed on the patient that determined that the seizure was a result of receiving ZOSTAVAX. The outcome of seizure was reported as recovering. The reporter considered seizure to be related to ZOSTAVAX. Upon internal review the event seizure was considered to be medically significant. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Movement disorder, Muscular weakness, Pain in extremity
Clinical narrative: This spontaneous report as received from a 65 year old female patient, reporting on herself with no pertinent medical history and no drug reactions or allergies. On 13-JUL-2013 the patient was vaccinated with ZOSTAVAX on upper left arm (dose and product lot # not reported). In the morning of 03-AUG-2013, 22 days after onset of therapy, while traveling, developed pain in her left shoulder blade that progressed consistently for 23 hours into her arm on a pain level of 3 or 4 level based on a scale of 1 to 10 (1 being the lowest). On 04-AUG-2013, the pain had progressed to a level 10 in severity and that point the patient went to the hospital, where she was treated and released. The patient had seen multiple physicians, including a neurologist and now had several lab tests (electromyogram (EMG)/NVC, X-rays, Magnetic Resonance Imaging (MRI) conducted on 04-AUG-2013 and finally diagnosed with brachial neurotics. The patient was treated with VICODIN and prednisone (manufacturer unknown) (dose unspecified). The patient was undergoing physical therapy as a result of the weakness in her left arm and leg. By the time of the report the patient had no feeling in her left thumb. The outcome of brachial neurotics was reported as not recovered/not resolved. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Electromyogram abnormal, Hypoaesthesia, Muscular weakness, Musculoskeletal pain, Nerve conduction studies abnormal
Clinical narrative: This spontaneous report as received from a 65 year old female patient, reporting on herself with no pertinent medical history and no drug reactions or allergies. On 13-JUL-2013 the patient was vaccinated with ZOSTAVAX on upper left arm (dose and product lot # not reported). In the morning of 03-AUG-2013, 22 days after onset of therapy, while traveling, developed pain in her left shoulder blade that progressed consistently for 23 hours into her arm on a pain level of 3 or 4 level based on a scale of 1 to 10 (1 being the lowest). On 04-AUG-2013, the pain had progressed to a level 10 in severity and that point the patient went to the hospital, where she was treated and released. The patient had seen multiple physicians, including a neurologist and now had several lab tests (electromyogram (EMG)/NVC, X-rays, Magnetic Resonance Imaging (MRI) conducted on 04-AUG-2013 and finally diagnosed with brachial neurotics. The patient was treated with VICODIN and prednisone (manufacturer unknown) (dose unspecified). The patient was undergoing physical therapy as a result of the weakness in her left arm and leg. By the time of the report the patient had no feeling in her left thumb. The outcome of brachial neurotics was reported as not recovered/not resolved. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Nuclear magnetic resonance imaging abnormal, Pain in extremity, Radiculitis brachial, X-ray abnormal
Clinical narrative: This spontaneous report as received from a 65 year old female patient, reporting on herself with no pertinent medical history and no drug reactions or allergies. On 13-JUL-2013 the patient was vaccinated with ZOSTAVAX on upper left arm (dose and product lot # not reported). In the morning of 03-AUG-2013, 22 days after onset of therapy, while traveling, developed pain in her left shoulder blade that progressed consistently for 23 hours into her arm on a pain level of 3 or 4 level based on a scale of 1 to 10 (1 being the lowest). On 04-AUG-2013, the pain had progressed to a level 10 in severity and that point the patient went to the hospital, where she was treated and released. The patient had seen multiple physicians, including a neurologist and now had several lab tests (electromyogram (EMG)/NVC, X-rays, Magnetic Resonance Imaging (MRI) conducted on 04-AUG-2013 and finally diagnosed with brachial neurotics. The patient was treated with VICODIN and prednisone (manufacturer unknown) (dose unspecified). The patient was undergoing physical therapy as a result of the weakness in her left arm and leg. By the time of the report the patient had no feeling in her left thumb. The outcome of brachial neurotics was reported as not recovered/not resolved. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Injection site pain, Throat tightness
Clinical narrative: Arm pain at administration site, throat tightening and difficulty breathing within 6 hrs of admin.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site irritation, Injection site warmth
Clinical narrative: This spontaneous report was received from a doctor of pharmacy concerning an approximately 61 year old female patient with no drug reactions or allergies. Current condition of the patient included hypertension. On 29-AUG-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot number and expiry date were reported as J002693 and 07-JUN-2014 respectively, dose unspecified), subcutaneously. Concomitant medication included an unspecified blood pressure medication. On 31-AUG-2013, the patient began to experience injection site reactions like local irritation, warmth, and redness. The patient sought medical attention. The pharmacist noted that no rash had occurred. No treatment was given. No lab tests were performed. The patient was not recovered from the events as the patient was still experiencing these injection site reactions when she called the pharmacy at the time of reporting (09-SEP-2013). The relatedness for the events was unknown for ZOSTAVAX. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth, Pain
Clinical narrative: Day 1- 8/31/13 - No symptoms; Day 2- 9/1/13 - Intense body ache all over shot site-sore and hot slept all day; Day 3 - 9/2/13 - Shot site - red-hot-itchy no fever-no breathing problems - sore hot arm for 5 days, sore arm-itchy.
Age: 12.0
Sex: M
Vaccine: FLU3, MNQ
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: No initial reaction following IM injections. However, overnight, patient developed significant swelling, erythema, induration, and warmth to the left upper arm and shoulder around the area of injection. No weaping or drainage. No fevers. Denies shortness of breath, wheezing/coughing. No facial swelling. Denies mouth tingling. No vomiting/diarrhea.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant reported that an unknown number of patients were administered M-M-R II (lot number, dose, route and indication unspecified) since June 2013 that had been improperly stored. The medical assistant was unable to provide the exact number of identities of the patients involved at the time of the report. No adverse effects reported. It was unspecified if the patients had sought medical attention. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. On 05-SEP-2013 the patient was vaccinated with an expired dose of M-M-R II (lot# 1293AA, expiry:09-AUG-2013). No adverse effects reported. Additional information has been requested.
Age: 1.3
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 15 month old patient. On 10-SEP-2013, the patient was inadvertently vaccinated with a dose of 0.5 ml PROQUAD, (lot number, expiry date was not reported and route was subcutaneous) and other suspect therapies included VARIVAX (Merck) (lot number, expiry date and route was not reported) at the same time. No adverse events were reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Hypoaesthesia
Clinical narrative: This spontaneous report was received from a physician refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with a dose of GARDASIL (lot #, expiry not reported) in the arm. On an unknown date, the patient experienced numbness in the vaccinated arm after receiving a dose of GARDASIL. Physician stated the numbness resolved itself a couple hours later. This is 1 of 2 reports received from the same reporter. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Hypoaesthesia
Clinical narrative: This spontaneous report was received from a physician refers to a 16 year old female patient. On 18-FEB-2013, the patient was vaccinated with a dose of GARDASIL (lot # H020901, expiry: 05-JUL-2015) in the arm. On 18-FEB-2013, the patient experienced numbness in the arm that was vaccinated. Patient sought medical attention. Physician stated the patient came into the office on an unspecified later date, to receive another dose of GARDASIL, and reported this adverse event to the physician. The patient reported the numbness resolved itself within 24 hours (approximately on 19-FEB-2013). This is 1 of 2 reports received from the same reporter. Additional information has been requested.
Age: 1.1
Sex: U
Vaccine: HIBV
Symptoms: Incorrect dose administered, No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from Registered Nurse refers to a 13 month old patient. On 04-SEP-2013 the patient was inadvertently vaccinated with two dose of the same lot PEDVAXHIB (lot # H017031, expiration date 16-JAN-2015, 0.5 ml, intramuscularly) in the same leg. The administering nurse had mistaken the second dose of PEDVAXHIB for an unspecified Hepatitis A vaccine (manufacturer unknown)(lot # not reported). The patient had no had any adverse effects. It was unspecified whether the patient sought for medical attention. Additional information has been requested.
Age: 21.0
Sex: M
Vaccine: HEPA, HPV4
Symptoms: Dyskinesia, Fall, Hyperhidrosis, Immediate post-injection reaction, Malaise
Clinical narrative: Was given Hep A then HPV. He said ouch and then fainted. He fell off the exam table and hit the floor. Very sweaty and not feeling well afterward. By report had approx. 10 seconds of lower leg movements when he fell. He got up off the floor on his own and climb back on the table.
Age: 21.0
Sex: M
Vaccine: HEPA, HPV4
Symptoms: Skull X-ray, Spinal X-ray, Syncope
Clinical narrative: Was given Hep A then HPV. He said ouch and then fainted. He fell off the exam table and hit the floor. Very sweaty and not feeling well afterward. By report had approx. 10 seconds of lower leg movements when he fell. He got up off the floor on his own and climb back on the table.
Age: 1.02
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Erythema, Pyrexia, Urticaria
Clinical narrative: Child had three (3) hives (dime to penny size) red with white center 30 minutes after vaccinations given.  One on his right leg and one on each buttock.  No other S/S and they were gone by 2:30 to 2:50pm the same day.  Mom thought he had a low-grade fever, but she did not check his temperature. Follow-up telephone call the next morning - mom said he was fine, acting normal.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Dizziness, Headache, Nausea, Pain
Clinical narrative: Severe body aches, chills, fever, headache, nausea and dizziness/lightheadness and vomiting.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia, Vomiting
Clinical narrative: Severe body aches, chills, fever, headache, nausea and dizziness/lightheadness and vomiting.
Age: 30.0
Sex: M
Vaccine: FLU3, HEP
Symptoms: Fatigue, Headache, Nausea
Clinical narrative: Acute fatigue, headache and nausea.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Migraine, Ocular hyperaemia, Pain
Clinical narrative: Within several hours of vaccination; body aches, blood shot eyes and severe migraine.
Age: 66.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Chills, Headache, Vomiting
Clinical narrative: Severe chills, vomiting, headache.
Age: 66.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Chills, Headache, Injected limb mobility decreased, Pyrexia, Vomiting
Clinical narrative: Severe chills, vomiting, headache.
Age: 0.49
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Cough, Pertussis, Sleep disorder
Clinical narrative: Initial report received on 03 September 2013 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis disease in a 3-year-old male subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received the following 3 doses of PENTACEL vaccinations: lot C3228AA received on 08 June 2009, lot C3290AA received on 03 August 2009, and lot C3231AA received on 29 September 2009. The subject developed a cough on 05 August 2013, approximately 4 years after the last dose, and a paroxysmal cough without a whoop on 13 August 2013. The subject also developed sleep disturbance (start date not reported). No laboratory testing or chest x-rays were reported. Corrective treatments consisted of azithromycin starting on 05 August 2013 for 5 days. The subject was not hospitalized. At the time of final contact on 19 August 2013, the subject's cough was still persisting. The duration of the cough was reported at that time as 14 days. This case was epidemiologically linked. Investigator causality assessment is not required as per protocol. This is one case out of a cumulative total of 211 cases solicited from the EDSS database during the surveillance period from 01 January 2010 to 03 September 2013. These 211 cases represent children who received 3 or more doses of sanofi pasteur vaccine; cases of pertussis disease in children who received DTaP combination vaccines from other manufacturers are not reported as per study protocol. Documents held by sender: None.
Sex: U
Vaccine: TDAP
Symptoms: Foetal death, Foetal exposure during pregnancy, Umbilical cord thrombosis
Clinical narrative: Initial information was received 03 September 2013 from a healthcare professional. A fetus was exposed in-utero to ADACEL vaccine (Lot number U4421AA) and an injection of Influenza vaccine (lot number not reported, manufacturer unknown) on unspecified dates. On 10 December 2012, the complication of fetal demise occurred due to umbilical cord occlusion with fetal vascular thrombus formation at 32.1 weeks. The outcome was fatal. This case is linked to the non-serious mother case 2012-11414. Documents held by sender: None.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Depression, Exposure during pregnancy, Guillain-Barre syndrome, Hypothyroidism, Syncope
Clinical narrative: Initial report received from a healthcare professional on 04 September 2012. A female patient had received an intramuscular (IM) first dose of ADACEL vaccine (Sanofi Pasteur Ltd lot number U4384AA) in right deltoid on unspecified date. The date of Last Menstrual Period was 27 December 2011. Estimated Date of Delivery was reported as 29 September 2012. It was reported that the patient did not experienced any adverse event. The patient's obstetrical history, current medical history, and concomitant medication were not provided. The patient's outcome was unknown. Follow-up information was received 03 September 2013 from a health care professional. Based upon new information received, this case now meets seriousness criteria and has been updated to serious. Relevant illness during pregnancy/ongoing was reported as depression, syncope, hypothyroid and GBS(+). Medications used during pregnancy were AMBIEN, NEXIUM, SYNTHROID and VALTREX. The patient had one previous pregnancy with a normal outcome. On 25 September 2012, the patient delivered a normal infant. The patient's outcome for the events of depression, syncope, hypothyroid and GBS(+) was not reported. Documents held by sender: None.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Pre-eclampsia
Clinical narrative: Initial report received from a health care professional on 07 September 2012. A 32-year-old female patient, whose concomitant medications and medical history was not reported, had received an intramuscular first dose of ADACEL on 07 September 2012 (lot number: U4384AA, expiry date: 11-30-14, anatomical site of vaccination was not reported). The patient was pregnant at the time of vaccination. The patient's last menstrual period date (LMP) was 05 April 2012 and expected date of delivery (EDD) is: 24 September 2012. As of 07 September 2012, the patient did not experience any adverse events. Follow-up information received from a health care professional on 03 September 2013. The patient experienced pre-eclampsia during the pregnancy, date not reported. The mother had a history of two pregnancies, details not provided. The pregnancy outcome was normal. The end of pregnancy date was reported as 15 September 2012 and the birth outcome was normal. The patient also received AFLURIA during pregnancy, manufacturer unknown, dose, date of vaccination and route not reported. It was reported that the patient did not experienced an adverse event following vaccination. Documents held by sender: none.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Oligohydramnios
Clinical narrative: Initial report received from a health care professional on 11 September 2012. A 29 year old female patient whose medical history and concomitant medications were not reported, had received first dose of intramuscular ADACEL vaccine (Lot number: U4393BA) at right deltoid region on 07 September 2012. The patient's date of last menstrual period was 13 December 2011 and the estimated date of delivery was reported 18 September 2012. At the time of the report, the patient had not experienced any adverse events. At the time of this report, the patient's outcome was unknown. Follow-up information was received 03 September 2013 from a health care professional. Based upon information received, this case now meets seriousness criteria and has been upgraded to serious. The patient experienced oligohydramnios. Maternal history included one previous pregnancy. The patient delivered a normal infant on 07 September 2012. Outcome was not reported. Documents held by sender: none.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Anaemia, Exposure during pregnancy, Thrombocytopenia
Clinical narrative: Initial report received from a healthcare professional on 13 September 2012. A 32-year-old pregnant female patient, had received an intramuscular (IM) first dose of ADACEL vaccine on 13 September 2012 (lot number U4384AA, anatomical site of vaccination was not reported). The date of the patient Last Menstrual Period was 07 February 2012. Estimated Date of Delivery was reported as 14 November 2012. It was reported that the patient did not experienced any adverse event. The patient's obstetrical history, current medical history, and concomitant medication were not provided. The patient treatment for infertility was included In vitro fertilization (IVF). The outcome was reported as unknown. Follow-up information was received 03 September 2013 from a health care professional. Based upon new information received, this case now meets seriousness criteria and has been upgraded to serious. Relevant illness during pregnancy/ongoing included thrombocytopenia and anemia. Medications used during pregnancy consisted of MAXARON FORTE, "Tetanus", RHOGAM and "Flu" (manufacturers, lot numbers, routes, sites and dates of administration not reported). Maternal history consisted of one pregnancy with a normal outcome. On 24 October 2012, the patient deliver twins; outcomes reported as normal. The outcome for the events of thrombocytopenia and anemia were not reported. Documents held by sender: None.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Chills, Headache, Pain, Pyrexia
Clinical narrative: Body aches, severe back pain, severe chills, fever, vomiting, headache. Never had side effects from reg. flu shot before / better in 24 hours.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: Body aches, severe back pain, severe chills, fever, vomiting, headache. Never had side effects from reg. flu shot before / better in 24 hours.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site warmth
Clinical narrative: Two days after immunization, the site started getting red and warm. One week later site is still red and warm. It is an unraised rash about the size of a half-dollar. It no longer itches. UP to this point, patient has not taken anything for symptoms. I recommended that she notify doctor and that she should use a cool compress/ice pack if the warmth was annoying and she could use hydrocortisone cream or take Benadryl if she chose to.
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Asthma, Condition aggravated, Urticaria, Vomiting, Wheezing
Clinical narrative: Hives 6 hours post injection. 2-3 episodes of vomiting with hives, also had asthma flare with some wheezing. Hives x 12 hours resolved with PO Benadryl.
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Swelling, Tenderness
Clinical narrative: Patient returned to pharmacy because there was/is swelling redness day after 9/12 after vaccine administration: (around 2 inches) swelling, tenderness.
Age: 47.0
Sex: F
Vaccine: FLUX
Symptoms: Rash pruritic
Clinical narrative: Significant, pruritic rash on trunk and extremities.
Age: 5.0
Sex: F
Vaccine: FLUN4
Symptoms: Computerised tomogram normal, Dyskinesia, Eye movement disorder, Facial paresis, VIIth nerve paralysis
Clinical narrative: Right facial weaknesss (Bell's Palsy) onset 8/29/12. Seen in ED, had normal CT, treated with oral prednisolone. Seen my office 9/6/13, mildly improved per parent, still with (now mild) right facial weakness (eyebrow and eye movement improved, right side of mouth stiff and not movng well). Improved, expected to recover eventually.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Erythema, Nausea, Pain in extremity, Upper extremity mass, Vomiting
Clinical narrative: Noticed lump in right arm, size of quarter, red and painful, approx. 6 cm below right deltoid. Had nausea and vomiting day before noticing the lump.
Age: 44.0
Sex: M
Vaccine: MMR
Symptoms: Chills, Diarrhoea, Hyperhidrosis, Nausea, Rhinorrhoea
Clinical narrative: Chills, sweating, nausea, runny nose, diarrhea.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Headache, Nausea, Pyrexia
Clinical narrative: First a headache, followed by fever.  Fever rose to 101.5 by about 6PM. Chills and some nausea accompanied the fever.  By 11:00, temperature was down to 98.7.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Pyrexia, Respiratory tract congestion
Clinical narrative: Severe chills for three hours, fever and stuffy head/nose/ears.
Age: 24.0
Sex: F
Vaccine: VARCEL
Symptoms: Asthenia, Dizziness, Injection site erythema, Injection site warmth
Clinical narrative: Dizziness, weakness, redness, warmth at site. Redness about size of an orange and warm to touch on 09/12/13 when reported to Emp Health.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Dysphonia, Eye discharge, Headache, Lip swelling
Clinical narrative: Sudden onset feeling "lump" on swallowing, uncontrollable coughing, hoarseness, swollen lips; later, visual blurring, head pressure, purulent drainage bilat eyes.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Purulent discharge, Sensation of foreign body, Vision blurred
Clinical narrative: Sudden onset feeling "lump" on swallowing, uncontrollable coughing, hoarseness, swollen lips; later, visual blurring, head pressure, purulent drainage bilat eyes.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Cough, Eye discharge, Ocular hyperaemia, Oropharyngeal pain
Clinical narrative: Shivers, dripping red eyes, sore throat, felt like something was stuck in throat, runny nose, cough, high fever 101.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia, Rhinorrhoea, Sensation of foreign body
Clinical narrative: Shivers, dripping red eyes, sore throat, felt like something was stuck in throat, runny nose, cough, high fever 101.
Age: 20.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: REDNESS, SWELLING AND ITCHING.
Age: 53.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Chills, Headache, Pruritus, Skin warm, Swelling
Clinical narrative: Noticed Raised, warm, itchy spot about size of sand dollar on 9/11/2013. Also had some chills and slight headache. Headache went away and came in to see doctor on 9/12.  No treatment.