chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Bursitis, Cellulitis, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Case number PHHY2013US127848 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 499832) website on 11 Nov 2013, with the follow-up received from Quality Assurance Department (reference number: 263635) on 17 Dec 2013: This report refers to a female patient of an unknown age. She was vaccinated with FLUVIRIN (batch number: 1205001) and PNEUMOVAX (batch number: H010515), both intramuscularly in the right arm on 20 Oct 2012. On 21 Oct 2012, she presented to the emergency room with redness, swelling and pain in arm where vaccinations were given. The patient was admitted to hospital and diagnosed with bursitis and cellulitis. The outcome of the events reported as recovered as of 13 Aug 2013. The causality of the events was not reported. Based on the investigation performed, QA department stated that, the concerned FLUVIRIN (batch number: 1205001) was manufactured in accordance with the approved internal procedures and it is in compliance with the cGMP requirements. Follow-up received from Quality Assurance Department (reference number: 263635) on 17 Dec 2013: Updated batch review report.
Age: 58.0
Sex: F
Vaccine: PPV
Symptoms: Aphagia, Axillary pain, Back pain, Chest pain, Fatigue
Clinical narrative: Severe pain in right arm, redness around location of vaccine application; aches and pains like flu, fever, fatigue, severe pain under arm, chest and back, very bad headaches, and it ruined my Christmas==very sick on stomach and cannot eat---for 72 hours now.
Age: 58.0
Sex: F
Vaccine: PPV
Symptoms: Headache, Influenza like illness, Injection site erythema, Nausea, Pain in extremity
Clinical narrative: Severe pain in right arm, redness around location of vaccine application; aches and pains like flu, fever, fatigue, severe pain under arm, chest and back, very bad headaches, and it ruined my Christmas==very sick on stomach and cannot eat---for 72 hours now.
Age: 58.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Severe pain in right arm, redness around location of vaccine application; aches and pains like flu, fever, fatigue, severe pain under arm, chest and back, very bad headaches, and it ruined my Christmas==very sick on stomach and cannot eat---for 72 hours now.
Sex: U
Vaccine: DTAPIPV, PPV, VARZOS, DTAPIPV, PPV, VARZOS
Symptoms: Chills, Headache, Injection site vesicles, Local reaction, Medication error
Clinical narrative: This spontaneous report as received from a nurse refers to patients of unknown age. On 17-DEC-2013 the nurse reported that 52 patients (demographics unspecified) were vaccinated with PNEUMOVAX23. Lot number and expiry date for PNEUMOVAX23 were reported as J011651 and 22-AUG-2014 respectively. Co-suspect therapies included ZOSTAVAX (lot J011338 exp date 19-DEC-2014) and DTAP both given on 17-DEC-2013. The nurse reported that all patients received PNEUMOVAX23, but that some of the patients may also have received ZOSTAVAX or DTAP administered concomitantly depending on circumstances and history of each patient. Approximately on December 2013 (within 12 to 24 hours following vaccination) the patients developed large and blistered injection site reactions, bigger local reactions, vomiting, nausea, fever, chills and headaches. The patients were treated with ALEVE and ibuprofen. Approximately on December 2013, the nurse reported that some of the patients (unspecified number) have missed 2 or three days of work (disability). The outcome of missed 2 or 3 days of work, bigger local reactions, some vomiting, nausea, fever, chills, headaches, patients developed injection site reactions and large and blistered was reported as recovering/resolving. The nurse reported that some of the patients are recovering quicker than other patients, but all are expected to completely recover. Causality of events was unknown. This case is linked to 1312USA010164 via same reporter link. Additional information has been requested.
Sex: U
Vaccine: DTAPIPV, PPV, VARZOS, DTAPIPV, PPV, VARZOS
Symptoms: Nausea, Pyrexia, Vomiting
Clinical narrative: This spontaneous report as received from a nurse refers to patients of unknown age. On 17-DEC-2013 the nurse reported that 52 patients (demographics unspecified) were vaccinated with PNEUMOVAX23. Lot number and expiry date for PNEUMOVAX23 were reported as J011651 and 22-AUG-2014 respectively. Co-suspect therapies included ZOSTAVAX (lot J011338 exp date 19-DEC-2014) and DTAP both given on 17-DEC-2013. The nurse reported that all patients received PNEUMOVAX23, but that some of the patients may also have received ZOSTAVAX or DTAP administered concomitantly depending on circumstances and history of each patient. Approximately on December 2013 (within 12 to 24 hours following vaccination) the patients developed large and blistered injection site reactions, bigger local reactions, vomiting, nausea, fever, chills and headaches. The patients were treated with ALEVE and ibuprofen. Approximately on December 2013, the nurse reported that some of the patients (unspecified number) have missed 2 or three days of work (disability). The outcome of missed 2 or 3 days of work, bigger local reactions, some vomiting, nausea, fever, chills, headaches, patients developed injection site reactions and large and blistered was reported as recovering/resolving. The nurse reported that some of the patients are recovering quicker than other patients, but all are expected to completely recover. Causality of events was unknown. This case is linked to 1312USA010164 via same reporter link. Additional information has been requested.
Sex: U
Vaccine: DTAPIPV, PPV, VARZOS, DTAPIPV, PPV, VARZOS
Symptoms: Activities of daily living impaired, Chills, Headache, Injection site vesicles, Local reaction
Clinical narrative: This spontaneous report as received from a nurse refers to patients of unknown age. On 17-DEC-2013 the nurse reported that 52 patients (demographics unspecified) were vaccinated with PNEUMOVAX23. Lot number and expiry date for PNEUMOVAX23 were reported as J011651 and 22-AUG-2014 respectively. Co-suspect therapies included ZOSTAVAX (lot J011338 exp date 19-DEC-2014) and DTAP both given on 17-DEC-2013. The nurse reported that all patients received PNEUMOVAX23, but that some of the patients may also have received ZOSTAVAX or DTAP administered concomitantly depending on circumstances and history of each patient. Approximately on December 2013 (within 12 to 24 hours following vaccination) the patients developed large and blistered injection site reactions, bigger local reactions, vomiting, nausea, fever, chills and headaches. The patients were treated with ALEVE and ibuprofen. Approximately on December 2013, the nurse reported that some of the patients (unspecified number) have missed 2 or three days of work (disability). The outcome of missed 2 or 3 days of work, bigger local reactions, some vomiting, nausea, fever, chills, headaches, patients developed injection site reactions and large and blistered was reported as recovering/resolving. The nurse reported that some of the patients are recovering quicker than other patients, but all are expected to completely recover. Causality of events was unknown. This case is linked to 1312USA010164 via same reporter link. Additional information has been requested.
Sex: U
Vaccine: DTAPIPV, PPV, VARZOS, DTAPIPV, PPV, VARZOS
Symptoms: Chills, Headache, Injection site vesicles, Local reaction, Medication error
Clinical narrative: This spontaneous report as received from a nurse refers to patients of unknown age. On 17-DEC-2013 the nurse reported that 52 patients (demographics unspecified) were vaccinated with PNEUMOVAX23. Lot number and expiry date for PNEUMOVAX23 were reported as J011651 and 22-AUG-2014 respectively. Co-suspect therapies included ZOSTAVAX (lot J011338 exp date 19-DEC-2014) and DTAP both given on 17-DEC-2013. The nurse reported that all patients received the PNEUMOVAX23, but that some of the patients may also have received ZOSTAVAX or DTAP administered concomitantly depending on circumstances and history of each patient. Approximately on December 2013 (within 12 to 24 hours following vaccination) the patients developed large and blistered injection site reactions, bigger local reactions, vomiting, nausea, fever, chills and headaches. The patients were treated with ALEVE and ibuprofen. Approximately on December 2013, the nurse reported that some of the patients (unspecified number) have missed 2 or three days of work (disability). The outcome of missed 2 or 3 days of work, bigger local reactions, some vomiting, nausea, fever, chills, headaches, patients developed injection site reactions and large and blistered was reported as recovering/resolving. The nurse reported that some of the patients are recovering quicker than other patients, but all are expected to completely recover. Causality of events was unknown. This case is linked to 1312USA010164 via same reporter link. Additional information has been requested.
Sex: U
Vaccine: DTAPIPV, PPV, VARZOS, DTAPIPV, PPV, VARZOS
Symptoms: Nausea, Pyrexia, Vomiting
Clinical narrative: This spontaneous report as received from a nurse refers to patients of unknown age. On 17-DEC-2013 the nurse reported that 52 patients (demographics unspecified) were vaccinated with PNEUMOVAX23. Lot number and expiry date for PNEUMOVAX23 were reported as J011651 and 22-AUG-2014 respectively. Co-suspect therapies included ZOSTAVAX (lot J011338 exp date 19-DEC-2014) and DTAP both given on 17-DEC-2013. The nurse reported that all patients received the PNEUMOVAX23, but that some of the patients may also have received ZOSTAVAX or DTAP administered concomitantly depending on circumstances and history of each patient. Approximately on December 2013 (within 12 to 24 hours following vaccination) the patients developed large and blistered injection site reactions, bigger local reactions, vomiting, nausea, fever, chills and headaches. The patients were treated with ALEVE and ibuprofen. Approximately on December 2013, the nurse reported that some of the patients (unspecified number) have missed 2 or three days of work (disability). The outcome of missed 2 or 3 days of work, bigger local reactions, some vomiting, nausea, fever, chills, headaches, patients developed injection site reactions and large and blistered was reported as recovering/resolving. The nurse reported that some of the patients are recovering quicker than other patients, but all are expected to completely recover. Causality of events was unknown. This case is linked to 1312USA010164 via same reporter link. Additional information has been requested.
Sex: U
Vaccine: DTAPIPV, PPV, VARZOS, DTAPIPV, PPV, VARZOS
Symptoms: Activities of daily living impaired, Chills, Headache, Injection site vesicles, Local reaction
Clinical narrative: This spontaneous report as received from a nurse refers to patients of unknown age. On 17-DEC-2013 the nurse reported that 52 patients (demographics unspecified) were vaccinated with PNEUMOVAX23. Lot number and expiry date for PNEUMOVAX23 were reported as J011651 and 22-AUG-2014 respectively. Co-suspect therapies included ZOSTAVAX (lot J011338 exp date 19-DEC-2014) and DTAP both given on 17-DEC-2013. The nurse reported that all patients received the PNEUMOVAX23, but that some of the patients may also have received ZOSTAVAX or DTAP administered concomitantly depending on circumstances and history of each patient. Approximately on December 2013 (within 12 to 24 hours following vaccination) the patients developed large and blistered injection site reactions, bigger local reactions, vomiting, nausea, fever, chills and headaches. The patients were treated with ALEVE and ibuprofen. Approximately on December 2013, the nurse reported that some of the patients (unspecified number) have missed 2 or three days of work (disability). The outcome of missed 2 or 3 days of work, bigger local reactions, some vomiting, nausea, fever, chills, headaches, patients developed injection site reactions and large and blistered was reported as recovering/resolving. The nurse reported that some of the patients are recovering quicker than other patients, but all are expected to completely recover. Causality of events was unknown. This case is linked to 1312USA010164 via same reporter link. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, No adverse event, Product quality issue
Clinical narrative: This spontaneous report as received from a pharmacist refers to an unspecified number of unspecified patients. On an unknown date the patients were vaccinated with does of a volume of 0.6 to 0.63 ml ZOSTAVAX vial 19400 PFU, lot #, expiration date and route unspecified. Product quality control (PQC) involved. No adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: PPV, PPV
Symptoms: Chills, Headache, Injection site reaction, Nausea, Pyrexia
Clinical narrative: This spontaneous report as received from a nurse refers to 52 patients of unknown age. On 17-DEC-2013 the nurse reported that 52 patients (demographics unspecified) were vaccinated with PNEUMOVAX23. Lot number and expiry date were reported as J011651 and 22-AUG-2014 respectively. Approximately on an unknown date in December 2013 (within 12 to 24 hours following vaccination) the patients developed injection site reactions, vomiting, nausea, fever, chills and headaches. Approximately on an unknown date in December 2013, the nurse reported that some of the patients (unspecified number) have missed 2 or three days of work (disability). Treatment given for adverse events included ALEVE and Ibuprofen. The outcome of missed 2 or 3 days of work, some vomiting, nausea, fever, chills, headaches and patients developed injection site reactions was reported as recovering/resolving. The nurse reported that some of the patients are recovering quicker than other patients, but all are expected to completely recover. Causality of events was unknown. This is one of the two reports received from the same reporter (#1312USA010905). Additional information has been requested.
Sex: U
Vaccine: PPV, PPV
Symptoms: Vomiting
Clinical narrative: This spontaneous report as received from a nurse refers to 52 patients of unknown age. On 17-DEC-2013 the nurse reported that 52 patients (demographics unspecified) were vaccinated with PNEUMOVAX23. Lot number and expiry date were reported as J011651 and 22-AUG-2014 respectively. Approximately on an unknown date in December 2013 (within 12 to 24 hours following vaccination) the patients developed injection site reactions, vomiting, nausea, fever, chills and headaches. Approximately on an unknown date in December 2013, the nurse reported that some of the patients (unspecified number) have missed 2 or three days of work (disability). Treatment given for adverse events included ALEVE and Ibuprofen. The outcome of missed 2 or 3 days of work, some vomiting, nausea, fever, chills, headaches and patients developed injection site reactions was reported as recovering/resolving. The nurse reported that some of the patients are recovering quicker than other patients, but all are expected to completely recover. Causality of events was unknown. This is one of the two reports received from the same reporter (#1312USA010905). Additional information has been requested.
Sex: U
Vaccine: PPV, PPV
Symptoms: Activities of daily living impaired, Chills, Headache, Injection site reaction, Nausea
Clinical narrative: This spontaneous report as received from a nurse refers to 52 patients of unknown age. On 17-DEC-2013 the nurse reported that 52 patients (demographics unspecified) were vaccinated with PNEUMOVAX23. Lot number and expiry date were reported as J011651 and 22-AUG-2014 respectively. Approximately on an unknown date in December 2013 (within 12 to 24 hours following vaccination) the patients developed injection site reactions, vomiting, nausea, fever, chills and headaches. Approximately on an unknown date in December 2013, the nurse reported that some of the patients (unspecified number) have missed 2 or three days of work (disability). Treatment given for adverse events included ALEVE and Ibuprofen. The outcome of missed 2 or 3 days of work, some vomiting, nausea, fever, chills, headaches and patients developed injection site reactions was reported as recovering/resolving. The nurse reported that some of the patients are recovering quicker than other patients, but all are expected to completely recover. Causality of events was unknown. This is one of the two reports received from the same reporter (#1312USA010905). Additional information has been requested.
Sex: U
Vaccine: PPV, PPV
Symptoms: Pyrexia, Vomiting
Clinical narrative: This spontaneous report as received from a nurse refers to 52 patients of unknown age. On 17-DEC-2013 the nurse reported that 52 patients (demographics unspecified) were vaccinated with PNEUMOVAX23. Lot number and expiry date were reported as J011651 and 22-AUG-2014 respectively. Approximately on an unknown date in December 2013 (within 12 to 24 hours following vaccination) the patients developed injection site reactions, vomiting, nausea, fever, chills and headaches. Approximately on an unknown date in December 2013, the nurse reported that some of the patients (unspecified number) have missed 2 or three days of work (disability). Treatment given for adverse events included ALEVE and Ibuprofen. The outcome of missed 2 or 3 days of work, some vomiting, nausea, fever, chills, headaches and patients developed injection site reactions was reported as recovering/resolving. The nurse reported that some of the patients are recovering quicker than other patients, but all are expected to completely recover. Causality of events was unknown. This is one of the two reports received from the same reporter (#1312USA010905). Additional information has been requested.
Sex: U
Vaccine: PPV, PPV
Symptoms: Chills, Headache, Injection site reaction, Nausea, Pyrexia
Clinical narrative: This spontaneous report as received from a nurse refers to 52 patients of unknown age. On 17-DEC-2013 the nurse reported that 52 patients (demographics unspecified) were vaccinated with PNEUMOVAX23. Lot number and expiry date were reported as J011651 and 22-AUG-2014 respectively. Approximately on an unknown date in December 2013 (within 12 to 24 hours following vaccination) the patients developed injection site reactions, vomiting, nausea, fever, chills and headaches. Approximately on an unknown date in December 2013, the nurse reported that some of the patients (unspecified number) have missed 2 or three days of work (disability). Treatment given for adverse events included ALEVE and ibuprofen. The outcome of missed 2 or 3 days of work, some vomiting, nausea, fever, chills, headaches and patients developed injection site reactions was reported as recovering/resolving. The nurse reported that some of the patients are recovering quicker than other patients, but all are expected to completely recover. Causality of events was unknown. This is one of the two reports received from the same reporter (#1312USA010905). Additional information has been requested.
Sex: U
Vaccine: PPV, PPV
Symptoms: Vomiting
Clinical narrative: This spontaneous report as received from a nurse refers to 52 patients of unknown age. On 17-DEC-2013 the nurse reported that 52 patients (demographics unspecified) were vaccinated with PNEUMOVAX23. Lot number and expiry date were reported as J011651 and 22-AUG-2014 respectively. Approximately on an unknown date in December 2013 (within 12 to 24 hours following vaccination) the patients developed injection site reactions, vomiting, nausea, fever, chills and headaches. Approximately on an unknown date in December 2013, the nurse reported that some of the patients (unspecified number) have missed 2 or three days of work (disability). Treatment given for adverse events included ALEVE and ibuprofen. The outcome of missed 2 or 3 days of work, some vomiting, nausea, fever, chills, headaches and patients developed injection site reactions was reported as recovering/resolving. The nurse reported that some of the patients are recovering quicker than other patients, but all are expected to completely recover. Causality of events was unknown. This is one of the two reports received from the same reporter (#1312USA010905). Additional information has been requested.
Sex: U
Vaccine: PPV, PPV
Symptoms: Activities of daily living impaired, Chills, Headache, Injection site reaction, Nausea
Clinical narrative: This spontaneous report as received from a nurse refers to 52 patients of unknown age. On 17-DEC-2013 the nurse reported that 52 patients (demographics unspecified) were vaccinated with PNEUMOVAX23. Lot number and expiry date were reported as J011651 and 22-AUG-2014 respectively. Approximately on an unknown date in December 2013 (within 12 to 24 hours following vaccination) the patients developed injection site reactions, vomiting, nausea, fever, chills and headaches. Approximately on an unknown date in December 2013, the nurse reported that some of the patients (unspecified number) have missed 2 or three days of work (disability). Treatment given for adverse events included ALEVE and ibuprofen. The outcome of missed 2 or 3 days of work, some vomiting, nausea, fever, chills, headaches and patients developed injection site reactions was reported as recovering/resolving. The nurse reported that some of the patients are recovering quicker than other patients, but all are expected to completely recover. Causality of events was unknown. This is one of the two reports received from the same reporter (#1312USA010905). Additional information has been requested.
Sex: U
Vaccine: PPV, PPV
Symptoms: Pyrexia, Vomiting
Clinical narrative: This spontaneous report as received from a nurse refers to 52 patients of unknown age. On 17-DEC-2013 the nurse reported that 52 patients (demographics unspecified) were vaccinated with PNEUMOVAX23. Lot number and expiry date were reported as J011651 and 22-AUG-2014 respectively. Approximately on an unknown date in December 2013 (within 12 to 24 hours following vaccination) the patients developed injection site reactions, vomiting, nausea, fever, chills and headaches. Approximately on an unknown date in December 2013, the nurse reported that some of the patients (unspecified number) have missed 2 or three days of work (disability). Treatment given for adverse events included ALEVE and ibuprofen. The outcome of missed 2 or 3 days of work, some vomiting, nausea, fever, chills, headaches and patients developed injection site reactions was reported as recovering/resolving. The nurse reported that some of the patients are recovering quicker than other patients, but all are expected to completely recover. Causality of events was unknown. This is one of the two reports received from the same reporter (#1312USA010905). Additional information has been requested.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Ophthalmic herpes zoster
Clinical narrative: This spontaneous report as received from a physician refers to approximately 65 year old male patient. The patient's pertinent medical history, drug reactions/allergies were none and had no other concomitant medications. On 26-DEC-2012 the patient was vaccinated with a dose of ZOSTAVAX, 0.65 milliliter (ml), subcutaneous in deltoid area. On 14-DEC-2013, the patient presented with supraorbital shingles (medically significant). The patient sought medical attention (office visit) and was treated with VALTREX. No laboratory diagnostic studies performed. The patient was seen 2 days later for follow up. Physician stated the event shingles was mild and the patient seemed to be stable, his eye seemed to be fine, and no other follow up was needed with the patient. The patient was recovering from the event. No product quality complaint (PQC) involved. Reporter's causality was not provided. The event was considered as medically significant since the event required intervention to prevent serious criteria. Additional information has been requested.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Confusional state, Incorrect dose administered
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 70 year old male patient. On 19-SEP-2012 the patient inadvertently received a dose of ZOSTAVAX (lot#, dose, route and indication not reported) in a doctor's office. And then on 29-JUN-2013, the patient received a dose of ZOSTAVAX a second time, (lot# and dose not reported), subcutaneous in a pharmacy. The pharmacist stated the patient was not a "regular" patient in pharmacy. Pharmacist stated patient was advised by physician's office to visit pharmacy about ZOSTAVAX he received. Pharmacist stated patient seemed a little confused when he came to pharmacy on 11-DEC-2013, no other effects reported. The outcome of the events was unknown. The patient had not sought medical attention. Additional information has been requested.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 51 year old female patient. On 01-MAY-2013, the patient was vaccinated with a dose of ZOSTAVAX, lot # J000492, expiration date January 2014, 0.65 ml, subcutaneous. The patient experienced a mild case of shingles, after receiving ZOSTAVAX in May 2013 and a second episode of shingles in August 2013. The patient was treated with acyclovir. The outcome of the events was unknown. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Delivery, Exposure during pregnancy, No adverse event
Clinical narrative: This spontaneous report was received from a physician refers to a 24 year old female patient. No medical history was reported. On an unspecified date in the year 2008 the patient was vaccinated with GARDASIL (dose 1, route unspecified) and then became pregnant. Concomitant medications were reported. On an unspecified date in 2009 the patient delivered a baby. No adverse event was reported. The reporting physician was not the patient's physician in either 2008 or 2009 and the reporting physician had limited information about the administration of the GARDASIL in 2008 and the pregnancy in 2009. Causality was not reported. Additional information is not expected.
Age: 1.73
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Chest X-ray normal, Cough, Laboratory test abnormal, Pertussis, Polymerase chain reaction
Clinical narrative: This is one case out of a cumulative total of 220 cases solicited from the EDSS database during the surveillance period from 01 January 2010 to 19 December 2013. These 220 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. Initial report received on 19 December 2013 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis disease in a 28-month-old female 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 4 doses of PENTACEL; lot number C3879AA received on 01 September 2011, lot number C3980AB received on 01 November 2011, lot number C4045AA on 04 Jan 2012 and lot number C4374AA on 23 March 2013 (routes and sites of administration not reported). On 13 November 2013, the subject developed a cough and paroxysmal cough on 13 November 2013 without a whoop. The subject also experienced sleep disturbance and vomiting. Laboratory testing included positive PCR on 14 November 2013. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 14 November 2013 for 5 days. The subject was not hospitalized. At the time of final contact on 27 November 2013, the subject's cough was still persisting. The duration of the cough was reported at that time as 14 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 1.73
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Sleep disorder, Vomiting
Clinical narrative: This is one case out of a cumulative total of 220 cases solicited from the EDSS database during the surveillance period from 01 January 2010 to 19 December 2013. These 220 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. Initial report received on 19 December 2013 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis disease in a 28-month-old female 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 4 doses of PENTACEL; lot number C3879AA received on 01 September 2011, lot number C3980AB received on 01 November 2011, lot number C4045AA on 04 Jan 2012 and lot number C4374AA on 23 March 2013 (routes and sites of administration not reported). On 13 November 2013, the subject developed a cough and paroxysmal cough on 13 November 2013 without a whoop. The subject also experienced sleep disturbance and vomiting. Laboratory testing included positive PCR on 14 November 2013. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 14 November 2013 for 5 days. The subject was not hospitalized. At the time of final contact on 27 November 2013, the subject's cough was still persisting. The duration of the cough was reported at that time as 14 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Sex: U
Vaccine: VARZOS
Symptoms: Hypersensitivity, Rash
Clinical narrative: This spontaneous report as received from a pharmacist via field representative refers to a two anonymous patients. On an unspecified date the two patients were vaccinated with ZOSTAVAX. Lot no.# and expiry date of vaccine are not provided. No other concomitant medications were reported. On an unknown date the patients experienced unspecified allergic reaction and rashes that were quarter size. The outcome of the both the event was unknown. The causality for unspecified allergic reaction and rashes that were quarter size was not provided. This case is linked to 1312USA010185 via same reporter link. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist, concerning to a patient of unknown age and gender. The patient pertinent medical history, drug reactions/allergies were not provided. On 05-DEC-2013, the patient was vaccinated with an expired dose of PNEUMOVAX23 (Lot # 1947AA, expiry date on 20-OCT-2013) (route and dose not reported). Co-suspect therapy and concomitant medications were not provided. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from an unknown reporter refers to a patient of unknown age. On an unknown date the patient was vaccinated with a dose of incorrect storage GARDASIL (lot # J003727, Expiration date 07-NOV-2015) (dose and route unspecified). This is one of several reports received from the same source. Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Areflexia, Asthenia, Hypoaesthesia, Local swelling, Nervous system disorder
Clinical narrative: This spontaneous report was received from a physician refers to a 50 year old female patient. On 10-DEC-2012, the patient was vaccinated with ZOSTAVAX (dose and frequency was not reported) lot # H013023. On 23-JAN-2013, 45 days after onset of therapy, the patient experienced neurological deficit in her right arm with pain, numbness and swelling and loss of deep tendon reflexes. The patient was sought medical attention. The physician also reported that the patient was still has residual numbness and decreased strength which was about 80% of normal. It was reported that the patient was treated with MEDROL dose pack and NEURONTIN. The outcome of the event neurological deficit in her right arm with pain, numbness and swelling and loss of deep tendon reflexes and decreased strength was reported as not recovered. The reporter did not provide the causality between the events and the suspect drug. Additional information has been requested.
Sex: M
Vaccine: FLUX
Symptoms: Aldolase normal, Areflexia, Asthenia, Blood creatine phosphokinase normal, Blood electrolytes normal
Clinical narrative: Case number PHHY2013US150396 is an initial literature report received from on 17 Dec 2013. The author discussed a rare case of relapse of chronic inflammatory demyelinating polyneuropathy (CIDP) after influenza vaccine. This report refers to a 78-years-old male patient. His medical history included illness with respiratory issues requiring tracheostomy after an upper respiratory infection when he was 10 years old. It was reported that he probably had an episode of Guillain-Barre syndrome (GBS) during his childhood. His concomitant medications were not reported. He was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on an unknown date. Few days after vaccination, the patient presented with five day history of generalized weakness. He also reported difficulty in getting up from a chair and difficulty while lifting his arm. Physical examination showed significant proximal as well as distal muscle weakness in bilateral upper and lower extremities. Sensations were preserved and reflexes were absent. His laboratory work up including electrolytes, thyroid stimulating hormone (TSH), creatine phosphokinase (CPK) and aldose levels were normal. Magnetic resonance imaging (MRI) head was remarkable. An electromyogram with nerve conduction study showed evidence of chronic inflammatory demyelinating polyneuropathy (CIDP). This episode was probably from activation of CIDP triggered by influenza vaccination. It was reported that the GBS episode during childhood might have developed into CIDP. He was promptly started on corticosteroids. He showed gradual improvement in weakness and was advised to avoid influenza vaccines. The outcome of the event was not reported. The author concluded the article stating that currently there was no definitive guideline regarding provision of influenza vaccine to someone with a history of relapse of CIDP with vaccination and that symptoms of weakness following vaccination should be promptly worked up for demyelinating polyneuropathies.
Sex: M
Vaccine: FLUX
Symptoms: Blood thyroid stimulating hormone normal, Chronic inflammatory demyelinating polyradiculoneuropathy, Condition aggravated, Dysstasia, Electromyogram abnormal
Clinical narrative: Case number PHHY2013US150396 is an initial literature report received from on 17 Dec 2013. The author discussed a rare case of relapse of chronic inflammatory demyelinating polyneuropathy (CIDP) after influenza vaccine. This report refers to a 78-years-old male patient. His medical history included illness with respiratory issues requiring tracheostomy after an upper respiratory infection when he was 10 years old. It was reported that he probably had an episode of Guillain-Barre syndrome (GBS) during his childhood. His concomitant medications were not reported. He was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on an unknown date. Few days after vaccination, the patient presented with five day history of generalized weakness. He also reported difficulty in getting up from a chair and difficulty while lifting his arm. Physical examination showed significant proximal as well as distal muscle weakness in bilateral upper and lower extremities. Sensations were preserved and reflexes were absent. His laboratory work up including electrolytes, thyroid stimulating hormone (TSH), creatine phosphokinase (CPK) and aldose levels were normal. Magnetic resonance imaging (MRI) head was remarkable. An electromyogram with nerve conduction study showed evidence of chronic inflammatory demyelinating polyneuropathy (CIDP). This episode was probably from activation of CIDP triggered by influenza vaccination. It was reported that the GBS episode during childhood might have developed into CIDP. He was promptly started on corticosteroids. He showed gradual improvement in weakness and was advised to avoid influenza vaccines. The outcome of the event was not reported. The author concluded the article stating that currently there was no definitive guideline regarding provision of influenza vaccine to someone with a history of relapse of CIDP with vaccination and that symptoms of weakness following vaccination should be promptly worked up for demyelinating polyneuropathies.
Sex: M
Vaccine: FLUX
Symptoms: Mobility decreased, Muscular weakness, Nerve conduction studies abnormal, Nuclear magnetic resonance imaging brain abnormal
Clinical narrative: Case number PHHY2013US150396 is an initial literature report received from on 17 Dec 2013. The author discussed a rare case of relapse of chronic inflammatory demyelinating polyneuropathy (CIDP) after influenza vaccine. This report refers to a 78-years-old male patient. His medical history included illness with respiratory issues requiring tracheostomy after an upper respiratory infection when he was 10 years old. It was reported that he probably had an episode of Guillain-Barre syndrome (GBS) during his childhood. His concomitant medications were not reported. He was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on an unknown date. Few days after vaccination, the patient presented with five day history of generalized weakness. He also reported difficulty in getting up from a chair and difficulty while lifting his arm. Physical examination showed significant proximal as well as distal muscle weakness in bilateral upper and lower extremities. Sensations were preserved and reflexes were absent. His laboratory work up including electrolytes, thyroid stimulating hormone (TSH), creatine phosphokinase (CPK) and aldose levels were normal. Magnetic resonance imaging (MRI) head was remarkable. An electromyogram with nerve conduction study showed evidence of chronic inflammatory demyelinating polyneuropathy (CIDP). This episode was probably from activation of CIDP triggered by influenza vaccination. It was reported that the GBS episode during childhood might have developed into CIDP. He was promptly started on corticosteroids. He showed gradual improvement in weakness and was advised to avoid influenza vaccines. The outcome of the event was not reported. The author concluded the article stating that currently there was no definitive guideline regarding provision of influenza vaccine to someone with a history of relapse of CIDP with vaccination and that symptoms of weakness following vaccination should be promptly worked up for demyelinating polyneuropathies.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site mass
Clinical narrative: Lump on left shoulder - Arm not red or swollen. Enlarging lump on (L) upper arm.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 18-NOV-2013 the patient was vaccinated with RECOMBIVAX HB (lot # J000722, expiration date 17-SEP-2015 (also reported as 17-SEP-2014)) injection, 10 microgram/ml 1 ml, intramuscular. The administered RECOMBIVAX HB was exposed to temperature conditions not supported by our in house stability data. No adverse effects were reported. No product quality complaint (PQC) was available. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 18-NOV-2013 the patient was vaccinated with PNEUMOVAX23 (lot # J005068, expiration date 18-JAN-2015) (dose and route unknown) which was exposed to an unsupported temperature excursion. No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Dyspnoea, Eye swelling, Lacrimation increased, Lip swelling
Clinical narrative: Difficulty breathing, eyes, throat, lips swelling, itchy throat, watery eyes, coughing.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Pharyngeal oedema, Throat irritation
Clinical narrative: Difficulty breathing, eyes, throat, lips swelling, itchy throat, watery eyes, coughing.
Age: 0.3
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Foetal exposure during pregnancy, Otitis media acute, Respiratory syncytial virus bronchiolitis
Clinical narrative: A report from a literature article concerns a 4 month old male infant. The author stated that the patient's mother received H1N1 vaccine at 37 weeks of pregnancy. At 4 months of age, the infant was hospitalized for 1 day with a diagnosis of respiratory syncytial virus bronchiolitis and acute otitis media. The outcome of the respiratory syncytial virus bronchiolitis and acute otitis media was unknown. Assessment of the serious criteria for the report was as follows: Hospitalised.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Body temperature decreased, Chills, Cough, Increased upper airway secretion, Urticaria
Clinical narrative: Patient reports cough and feeling like her throat was thickening and mucousy.  Progressed to a wheezy cough, then wheezes, then chills.  Says she took her temperature and it was 94.  She the said she developed hives on her neck. She said she took 2 Benadryl about 12:50 pm and called her physician.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Wheezing
Clinical narrative: Patient reports cough and feeling like her throat was thickening and mucousy.  Progressed to a wheezy cough, then wheezes, then chills.  Says she took her temperature and it was 94.  She the said she developed hives on her neck. She said she took 2 Benadryl about 12:50 pm and called her physician.
Age: 75.0
Sex: M
Vaccine: TDAP, VARZOS
Symptoms: Erythema, Local swelling, Tenderness
Clinical narrative: Patient stated: Red swelling, tenderness to arm & around, puffiness going down arm, no fever present, had not taken anything for discomfort.
Age: 92.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash, Rash vesicular
Clinical narrative: Varicella zoster-like rash on the chest (not at the site of immunization).
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Burning sensation, Laboratory test, Sensory disturbance
Clinical narrative: I have a burning and feeling of wetness on my face, back, neck, legs and arms. It is constant.  The burning is hardly bearable.
Age: 0.18
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Crying
Clinical narrative: Patient cried three hours after shots slept several minutes then continued to cry entire night.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report was received from a medical assistant refers to a patient of unknown age. The medical assistant reported that 10 patients were inadvertently vaccinated with PNEUMOVAX 23 during an unspecified 3 week period that had been improperly stored. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Hot/red/swollen at site x 3 days after admin.
Age: 0.75
Sex: M
Vaccine: FLU4
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 34.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Headache, Injection site bruising, Local reaction, Migraine
Clinical narrative: He c/o local reaction to 12/10/13 flu shot, (L) deltoid - 12/12/13. Today 12/17/13 it has improved and he said he can see a bruise over the site. He states he has had joint pain since 12/13/2013 that has been less pronounced today. He c/o migraine headaches the past 2 afternoons. He is taking TYLENOL - Ibuprofen for his aches and pains and headache. 12/18/13 call from pt symptoms have resolved.
Age: 34.0
Sex: M
Vaccine: FLU3
Symptoms: Pain
Clinical narrative: He c/o local reaction to 12/10/13 flu shot, (L) deltoid - 12/12/13. Today 12/17/13 it has improved and he said he can see a bruise over the site. He states he has had joint pain since 12/13/2013 that has been less pronounced today. He c/o migraine headaches the past 2 afternoons. He is taking TYLENOL - Ibuprofen for his aches and pains and headache. 12/18/13 call from pt symptoms have resolved.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Swelling
Clinical narrative: Patient complained of swelling over 24 hours after immunization.
Age: 81.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Erythema, Eye pain, Vomiting
Clinical narrative: Patient began having eye pain and redness on one side of face. She began vomiting and was getting weak. I called paramedics and sent her to the ER.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. The reporter stated that on an unknown date, an unspecified number of patients may have been administered GARDASIL that was exposed to an unsupported temperature excursion (30 degrees Fahrenheit for 2 hours), (lot number and expiration date unknown), dose, route, anatomical location and dose number unspecified for an unknown indication. No adverse effect was reported. Additional information has been requested.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Abdominal pain, Barium enema abnormal, Haematochezia, Intussusception, Muscle spasms
Clinical narrative: Presented as abd pain, cramping and bloody stools and when initially in outside facility seen sent home with formula change and returned because of worsening symptoms and admitted and with BE diagnosis of intussusception doc and transferred to hospital for surgery.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Surgery
Clinical narrative: Presented as abd pain, cramping and bloody stools and when initially in outside facility seen sent home with formula change and returned because of worsening symptoms and admitted and with BE diagnosis of intussusception doc and transferred to hospital for surgery.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age an gender. On 28-NOV-2012, 01-MAy-2013 and 15-JUL-2013 the patient was vaccinated with the three doses of GARDASIL respectively. No adverse effects were reported. Additional information has been requested.
Sex: M
Vaccine: FLUX
Symptoms: Death, Guillain-Barre syndrome
Clinical narrative: Initial report received from a healthcare professional (pharmacist) on 09 December 2013. This case is linked with cluster cases: 2013SA131929 and 2013SA131928 (Same vaccine, same reporter). A male patient, whose medical history and concomitant medications were not reported, had received a dose of Influenza QIV vaccine (manufacturer: not provided, lot number, dose number, route and anatomical site of administration were not reported) on an unspecified date. On an unspecified date after vaccination, the patient developed Guillain Barre Syndrome and the patient was died. Laboratory investigations and corrective treatments were not reported. No autopsy details were reported. Documents held by sender: none.
Age: 1.01
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Febrile convulsion
Clinical narrative: Febrile seizure on 12/20/13 at 0330 AM.