chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: M
Vaccine: PPV
Symptoms: Feeling abnormal, Productive cough, Pyrexia
Clinical narrative: PNEUMOVAX given 11/4/15. 11/5/15 fever 101.1 felt "blah". Went to ER. VS stable other than fever. Was discharged. Fever 103.7 on 11/6/15. Taking LEVAQUIN. Coughing up milky white phlegm.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unknown number of patients of unknown age and gender. The patient's pertinent medical history or concurrent conditions were not provided. On an unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ, Lot # K016314 and expiry date on 05-JUN-2017 (one dose administered), and Lot # L010126, expiry date on 22-JAN-2017 (three doses administered), (dose and route of administration were not provided). No adverse events were reported.
Age: 74.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth, Skin warm
Clinical narrative: Shot administered on 11-2-15. S/s started on 11-6-15. I saw on 11-9-15 when she came in. Her Lt. arm (upper) had approx 4 inch W x 2 inch red raised area. This area was warm to touch and approx. mid forearm approx 2 inches below injection site. Denies any other s/s besides itching at site.
Age: 67.0
Sex: M
Vaccine: FLU4
Symptoms: Feeling cold, Oropharyngeal pain, Pain, Sinus congestion
Clinical narrative: Aching all over, sore throat, head congestion, chills. No body temperature taken - called M.D. who called in Rx for AUGMENTIN. Sx started 11/6/15 evening time and today feeling better but still congested - took CLARITIN this A.M.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Headache, Injection site erythema, Injection site rash, Injection site warmth
Clinical narrative: Patient had red rash around injection site that was warm to touch. Patient had headache. Rash appeared morning after injection. MD was notified and prescribed BENADRYL 50mg sig 1 now and then BID for 5 days and prednisone 10mg (60mg x2 days, 50mg x2 days, 40 x2 days, 30 x2 days, 20 x2 days, and 10 x2 days).
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unknown number of patients of unknown age and gender. The patients' pertinent medical history or concurrent conditions were not provided. On an unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL, (Lot # L018286 and expiry date on 13-APR-2017) (dose and route of administration were not provided). No adverse events were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unknown number of patients of unknown age and gender. The patients' pertinent medical history or concurrent conditions were not provided. On an unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 (Lot # L016429 and expiry date on 30-AUG-2017) (dose and route of administration were not provided). No adverse events were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from the registered medical office manager referring to an unknown number of patients of unknown age and gender. The patients medical histories and concurrent conditions were not reported. On unspecified dates in 2015, reported "since 24-JUN-2015", the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (Lot# K02144, expiration date: 17-SEP-2016) (dose and route of administration were not reported). Concomitant medications were not reported. No adverse effects reported. There was not a product quality involved. This is one of the several reports from the same source. Additional information has been requested.
Age: 58.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Nausea, Pain in extremity, Skin warm
Clinical narrative: This spontaneous report was received from a registered nurse via a company representative with none drug reactions or allergies. The patient's medical history and concurrent conditions were not reported. It was reported that the patient was vaccinated with her first dose of PNEUMOVAX23 about 5 years ago. On 19-OCT-2015, the patient was vaccinated with the second dose of PNEUMOVAX23, 0.5 ml, intramuscular, at the arm, lot number L003188, expiration date 06-JUL-2016. The patient's concomitant therapies included unspecified OTC (over the counter) cold medicine. On an unknown date in 2015, the patient came into the office for follow up since her arm was completely red from deltoid area all the way down to elbow (injection site reaction). The patient stated that her arm was very painful (pain in extremity) ad hot to touch and she also experienced some nausea. The patient was treated with TYLENOL. The nurse stated that she was going to discontinue the PNEUMOVAX23 with the lot number L003188. At the time of the report, the outcome of her arm was completely red from deltoid area all the way down to elbow and hot to touch and the nausea was reported as not recovered. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unknown number of patients of unknown age and gender. The patient's pertinent medical history or concurrent conditions were not provided. On an unknown dates, the patients were vaccinated with improperly stored doses of MMR II, (Lot # reported as L015281 and expiry date on 30-APR-2017) (dose and route of administration were not provided). No adverse events were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant concerning a multiple unspecified patients of unknown ages and genders. The patient's pertinent medical history or concurrent conditions were not provided. In 2015, reported as ranging 01-MAY-2015 through 31-AUG-2015, the patients were vaccinated with improperly stored doses of VAQTA lot # K005323, expiration date: 10-FEB-2017 (route, anatomical location and dose were not reported). Co-suspect therapies or concomitant medications were not provided. No adverse effects was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site bruising
Clinical narrative: Patient developed a large bruise (size of baseball) in site of injection that has lasted >10 days.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from the registered medical office manager referring to an unknown number of patients of unknown age and gender. The patients' medical histories and concurrent conditions were not reported. On unspecified dates in 2015, reported "since 24-JUN-2015", the patients were vaccinated with improperly stored doses of ROTATEQ oral (lot # K016261, expiration date: 23-JUN-2016; L008034, expiration date: 05-AUG-2016). Concomitant medications were not reported. No adverse effects reported. There was not a product quality involved. This is one of the several reports from the same source. Additional information has been requested.
Age: 49.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Injection site swelling, Mobility decreased, Nausea, Pain in extremity
Clinical narrative: Fever/chills. Radiating pain in arm, unable to raise arm/bend. Swelling at site. Nausea.
Age: 49.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pyrexia
Clinical narrative: Fever/chills. Radiating pain in arm, unable to raise arm/bend. Swelling at site. Nausea.
Age: 62.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site pain, Injection site rash
Clinical narrative: Pain/soreness and rash around injection area, extending up into shoulder.
Age: 53.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Injection site swelling, Mobility decreased, Nausea, Pain in extremity
Clinical narrative: Rigors, fever/chills into the morning. Arm soreness, difficulty raising or bending arm, swelling at site, nausea, last temp at 9AM 10/28 99.8 degrees.
Age: 53.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pyrexia
Clinical narrative: Rigors, fever/chills into the morning. Arm soreness, difficulty raising or bending arm, swelling at site, nausea, last temp at 9AM 10/28 99.8 degrees.
Age: 34.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Headache, Nausea, Pain in extremity, Peripheral swelling
Clinical narrative: Swelling in arm, fever, chills, nausea, headache, extreme soreness in arm.
Age: 34.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pyrexia
Clinical narrative: Swelling in arm, fever, chills, nausea, headache, extreme soreness in arm.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site reaction
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a unspecified number of patients of unknown age and gender. Concurrent or medical conditions were not reported. On an unknown date, the patients were vaccinated with ZOSTAVAX (dose, strength, frequency, route and lot number were not reported). Secondary suspect and concomitant therapies were not reported. The nurse reported that 70-80% of all patient that were administered with ZOSTAVAX developed injection site reactions. The outcome of injection site reaction was not reported. This is one of two reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to an unspecified number of patients of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On an unknown date, the unspecified patients were vaccinated with improperly stored doses of VARIVAX (Merck) lot # J014129, expiration date 07-NOV-2015 and lot # K007781, expiration date 28-MAY-2016 (dose, frequency and route were not reported). No concomitant medications were reported. No adverse effects were reported. No product quality complaint was involved. This is one of two cases from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant concerning a multiple unspecified patients of unknown ages and genders. The patients' pertinent medical histories or concurrent conditions were not provided. In 2015, reported as ranging 01-MAY-2015 through 31-AUG-2015, the patients were vaccinated with improperly stored doses of oral, ROTATEQ lot # K016576, expiration date: 12-JUN-2016 (route, anatomical location and dose were not reported). Co-suspect therapies or concomitant medications were not provided. No adverse effect was reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to an unspecified number of patients of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On an unknown date, the unspecified patients were vaccinated with improperly stored doses of PROQUAD (Merck) lot # K019100, expiration date 15-MAR-2016 and lot # K020750, expiration date 30-APR-2016 (dose, frequency and route were not reported). No concomitant medications were reported. No adverse effects were reported. No product quality complaint was involved. This is one of two cases from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from the registered medical office manager referring to an unknown number of patients of unknown age and gender. The patients medical histories and concurrent conditions were not reported. On unspecified dates in 2015, reported "since 24-JUN-2015", the patients were vaccinated with improperly stored doses of VAQTA (Lot# L001849, expiration date: 02-FEB-2017; L008665, expiration date: 10-FEB-2017) (dose and route of administration were not reported). Concomitant medications were not reported. No adverse effects reported. There was not a product quality involved. This is one of the several reports from the same source. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Haematochezia, Ultrasound scan
Clinical narrative: This spontaneous report was received from a healthcare worker via a company representative and refers to a 70 year old female patient. The patient's concurrent conditions and medical history were not provided. On 02-NOV-2015, the patient was vaccinated with a dose of ZOSTAVAX (dose, route of administration, anatomical location, lot number and expiration date were not provided). There were no concomitant medications reported. On an unspecified date, in November 2015, the patient had blood in her stool. On 04-NOV-2015, the patient had an appointment for an ultrasound for an unspecified reason. The results of the ultrasound were not provided. At the time of the report; the outcome of haematochezia was unknown. The reporter considered haematochezia to be related to ZOSTAVAX. Additional information has been requested.
Age: 81.0
Sex: F
Vaccine: PNC13
Symptoms: Asthenia, Cyanosis, Ecchymosis, Full blood count, Metabolic function test
Clinical narrative: Asthenia date of vaccine, within hours, then left foot swollen and tender next 2-3 days and purple half of foot, per pt report. Photo today: dependent purple ecchymosis flexor foot above MTPs, X-ray pending denies trauma not limping.
Age: 81.0
Sex: F
Vaccine: PNC13
Symptoms: Peripheral swelling, Tenderness, X-ray limb
Clinical narrative: Asthenia date of vaccine, within hours, then left foot swollen and tender next 2-3 days and purple half of foot, per pt report. Photo today: dependent purple ecchymosis flexor foot above MTPs, X-ray pending denies trauma not limping.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse concerning an unspecified number of patients of unknown ages and genders. The patients' pertinent medical history or concurrent conditions were not provided. In November 2015, reported as between 04-NOV-2015 and 09-NOV-2015, the patients were vaccinated with improperly stored doses of GARDASIL, lot # K011492, expiration date: 22-JUN-2016 and Lot#: L007531, expiration date: 04-NOV-2018 (route, anatomical location and dose were not reported). Co-suspect therapies or concomitant medications were not provided. No adverse effect was reported. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose 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's pertinent medical history or concurrent conditions were not provided. On an unknown date, the patient was vaccinated with the first dose of ZOSTAVAX (route, dose, lot # and expiry date were not provided). It was reported that on unspecified date, the patient was inadvertently administered with a second dose of ZOSTAVAX (route, dose, lot # and expiry date were not provided). No adverse effects were reported. Additional information is not expected as reporter declined to participate in follow up collection process.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from the registered medical office manager referring to an unknown number of patients of unknown age and gender. The patients' medical histories and concurrent conditions were not reported. On unspecified dates in 2015, reported "since 24-JUN-2015", the patients were vaccinated with improperly stored doses of PROQUAD (Lot # K020751, expiration dose: 30-APR-2016; L007229, expiration dose: 03-SEP-2016; L024125, expiration dose: 30-DEC-2016) (dose and route of administration were not reported). Concomitant medications were not reported. No adverse effects reported. There was not a product quality involved. This is one of the several reports from the same source. Additional information has been requested.
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of mobility decreased in a 35-year-old female patient who received FLULAVAL quadrivalent (batch number H33J2, expiry date May 2016). In 2015, the patient received FLULAVAL quadrivalent .5 ml. On 27th October 2015, an unknown time after receiving FLULAVAL quadrivalent, the patient experienced mobility decreased and pain in arm. On an unknown date, the outcome of the mobility decreased and pain in arm were unknown. It was unknown if the reporter considered the mobility decreased and pain in arm to be related to FLULAVAL quadrivalent. Additional details provided were as follows: The healthcare professional reported that, there were 2 patients (for other patient see case US2015GSK159506) who received FLULAVAL quadrivalent and experienced the events. These reports could be a duplicate of a previous cases reported. However, according to the patient identifiers provided in both these case, no duplicate reports has been identified. An unspecified time after vaccination the patient in this concerned case experienced left arm pain and also the patient was unable to lift the left arm since 27th October 2015. The patient received physical therapy as a treatment.
Age: 51.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site pain, Insomnia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 51-year-old male patient who received FLUARIX QUADRIVALENT (batch number 7DT2Y, expiry date 30th June 2016). Concomitant products included Losartan Hydrochlorothiazide Actavis and Valacyclovir. On 18th October 2015, the patient received FLUARIX QUADRIVALENT .5 ml. On 23rd October 2015, 5 days after receiving FLUARIX QUADRIVALENT, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was not recovered/not resolved. The reporter considered the injection site pain to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: This case was previously reported to a manufacturer. According to the reporter, the patient did not experience any redness, swelling or inflammation at the site of injection. The pain was rated as 8 out of 10 with 10 being the worst, which kept him away from sleeping and on a continuous basis. The reporter quickly wanted to get off the phone because she wanted to visit medical information department for further assistance. The reported batch number (TDT2Y) for FLUARIX QIV did not exist and was updated to 7DT2Y as per the sales database.
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Mobility decreased, Pain in extremity, Swelling
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of mobility decreased in a adult female patient who received FLULAVAL QUADRIVALENT (batch number H33J2, expiry date May 2016). In 2015, the patient received FLULAVAL QUADRIVALENT .5 ml. On an unknown date, an unknown time after receiving FLULAVAL QUADRIVALENT, the patient experienced mobility decreased, pain in arm, weakness and swelling. On an unknown date, the outcome of the mobility decreased, pain in arm, weakness and swelling were unknown. It was unknown if the reporter considered the mobility decreased, pain in arm, weakness and swelling to be related to FLULAVAL QUADRIVALENT. Additional details provided were as follows: The healthcare professional reported that, there were 2 patients (for other patient see case US2015GSK159505) who received FLULAVAL QUADRIVALENT and experienced the events. These reports could be a duplicate of a previous cases reported. However, according to the patient identifiers provided in both these case, no duplicate reports has been identified. An unspecified time after vaccination, the patient in this concerned case experienced left upper arm pain, swollen, weakness and was unable to lift left arm. The patient received physical therapy as a treatment.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from the registered medical officer manager referring to an unknown number of patients of unknown age and gender. The patients medical histories and concurrent conditions were not reported. On unspecified dates in 2015, reported "since 24-JUN-2015", the patients were vaccinated with improperly stored doses of (Oka/Merck) VARIVAX (lot # K002928, expiration date: 26-FEB-2016; lot # J012210, expiration date 28-SEP-2015) (dose and route of administration were not reported). Concomitant medications were not reported. No adverse effects reported. There was no product quality involved. This is one of the several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant concerning a multiple unspecified patients of unknown ages and genders. The patients' pertinent medical histories or concurrent conditions were not provided. In 2015, reported as ranging 01-MAY-2015 through 31-AUG-2015, the patients were vaccinated with improperly stored doses of GARDASIL, lot # K008931, expiration date: 04-MAR-2017 (route, anatomical location and dose were not reported). Co-suspect therapies or concomitant medications were not provided. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site warmth, Musculoskeletal pain, Neck pain, Pain in extremity
Clinical narrative: Client states her arm became sore 10/10 at 3:10 on 11/10/15 after receiving flu shot at 2:50 in (R) deltoid. Pain radiates from shoulder to neck. No decreased ROM. 9 cm x 9 cm pink area at injection site warm to the touch.
Age: 11.0
Sex: F
Vaccine: HPV9, HPV4
Symptoms: Electroencephalogram normal, Generalised tonic-clonic seizure
Clinical narrative: Was given HPV vaccine and had a 5 min clonic tonic seizure 17 days later. Was given second HPV vaccine July 29, 2015 and another tonic clonic seizure occurred July 30, 2015. Has been having one seizure a week since then.
Age: 11.0
Sex: F
Vaccine: HPV9, HPV4
Symptoms: Computerised tomogram, Electroencephalogram, Epilepsy, Generalised tonic-clonic seizure, Nuclear magnetic resonance imaging
Clinical narrative: Was given HPV vaccine and had a 5 min clonic tonic seizure 17 days later. Was given second HPV vaccine July 29, 2015 and another tonic clonic seizure occurred July 30, 2015. Has been having one seizure a week since then.
Age: 2.0
Sex: M
Vaccine: FLUX, MMR, VARCEL, FLU3, MMR, VARCEL, FLU3, MMR, VARCEL
Symptoms: Cardiac arrest, Death, Resuscitation
Clinical narrative: This medically confirmed spontaneous report (initial receipt 29-Oct-2015) concerns a 2.5 year-old male patient who had a medical history of hyperplastic left heart and multiple unspecified heart surgeries. On 19-Oct-2015 at 12:30pm, the patient received unspecified influenza vaccine (Influenza virus vaccine, manufacturer and batch number not provided), subcutaneous MMR II injection (measles, mumps and rubella vaccine, batch number not provided) and Varivax (varicella virus vaccine, batch number not provided) for routine vaccinations. On 19-Oct-2015 at 12:50pm, the patient was brought back to the vaccination office and was apparently in cardiac arrest. CPR (cardiopulmonary resuscitation) was given. The ambulance was called and the patient was taken to the Medical Centre. The reporter received a call from the Coroner's office at 3:00pm and was informed that the patient died. The outcome was fatal. Reporter's Comments: Reporter's comments: The reporter considered the events serious due to death, and life threatening event. Sender's Comments: Company comments: Seriousness: Serious. Fatal outcome. Listedness: Unlisted. Brand of Influenza vaccine not specified. Assessment according to the CCDS for CSL Inactivated Influenza Virus Vaccine and the Afluria PI, cardiac arrest is unlisted. Drug administered to patient of inappropriate age is also unlisted as CSL IVV is not indicated for use in children under 5 years of age. Causality: Unassessable. Time to onset is 20 minutes of vaccination. The child had history of unspecified heart disease requiring multiple surgery. It is not known if the child received vaccine in past and how they were tolerated. The child's underlying condition at time of vaccination from a cardiovascular perspective, events leading to cardiac arrest were not specified. In addition an autopsy reports to ascertain cause of death was not provided. Underlying heart disease is thought to be the main contributing factor but this cannot be confirmed. Causality for this case is unassessable. Reported Cause(s) of Death: Unspecified by reporter.
Age: 2.0
Sex: M
Vaccine: FLUX, MMR, VARCEL, FLU3, MMR, VARCEL, FLU3, MMR, VARCEL
Symptoms: Death, Resuscitation, Unresponsive to stimuli
Clinical narrative: This medically confirmed spontaneous report (initial receipt 29-Oct-2015) concerns a 2.5 year-old male patient who had a medical history of hyperplastic left heart and multiple unspecified heart surgeries. On 19-Oct-2015 at 12:30pm, the patient received unspecified influenza vaccine (Influenza virus vaccine, manufacturer and batch number not provided), subcutaneous MMR II injection (measles, mumps and rubella vaccine, batch number not provided) and Varivax (varicella virus vaccine, batch number not provided) for routine vaccinations. On 19-Oct-2015 at 12:50pm, the patient was brought back to the vaccination office and was apparently in cardiac arrest. CPR (cardiopulmonary resuscitation) was given. The ambulance was called and the patient was taken to the Medical Centre. The reporter received a call from the Coroner's office at 3:00pm and was informed that the patient died. The outcome was fatal. Reporter's Comments: Reporter's comments: The reporter considered the events serious due to death, and life threatening event. Sender's Comments: Company comments: Seriousness: Serious. Fatal outcome. Listedness: Unlisted. Brand of Influenza vaccine not specified. Assessment according to the CCDS for CSL Inactivated Influenza Virus Vaccine and the Afluria PI, cardiac arrest is unlisted. Drug administered to patient of inappropriate age is also unlisted as CSL IVV is not indicated for use in children under 5 years of age. Causality: Unassessable. Time to onset is 20 minutes of vaccination. The child had history of unspecified heart disease requiring multiple surgery. It is not known if the child received vaccine in past and how they were tolerated. The child's underlying condition at time of vaccination from a cardiovascular perspective, events leading to cardiac arrest were not specified. In addition an autopsy reports to ascertain cause of death was not provided. Underlying heart disease is thought to be the main contributing factor but this cannot be confirmed. Causality for this case is unassessable. Reported Cause(s) of Death: Unspecified by reporter.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Fatigue, Headache, Herpes zoster, Influenza like illness, Pain
Clinical narrative: This spontaneous report was received from a pharmacist concerning a 63-year-old female patient with no allergies and pre-existing medical conditions. On 12-OCT-2015 at 15:53, the patient was vaccinated with the first dose of ZOSTAVAX 0.65 ml, once, subcutaneously in the arm near triceps, lot # L028280 (expiration date was not reported). There was no illness at the time of vaccination. On 16-OCT-2015, 4 days after receiving ZOSTAVAX, the patient experienced Flu-like symptoms, headache, body aches and fatigue, all of which lasted 3 full days. For the next 2 days, the patient felt a bit better and on approximately 21-OCT-2015 (reported as "2 days later"), fatigue and headache returned and she developed skin soreness, which increased over the next 72 hours. Then on approximately 24-OCT-2015, the patient developed a rash on her left side waist area, abdomen, and back. On 27-OCT-2015, the patient visited her physician who diagnosed the patient being confirmed to having shingles. There were no lab diagnostic studies performed. The patient was given valacyclovir 1g three times a day for 10 days as a treatment for the event. On an unknown date in 2015, the patient recovered from shingles. The relatedness between the event and ZOSTAVAX was not provided. The reporting pharmacist considered the event to be serious as a significant disability to the patient because she was "severely suffering" as a result. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain of skin, Rash, Ulcer
Clinical narrative: This spontaneous report was received from a pharmacist concerning a 63-year-old female patient with no allergies and pre-existing medical conditions. On 12-OCT-2015 at 15:53, the patient was vaccinated with the first dose of ZOSTAVAX 0.65 ml, once, subcutaneously in the arm near triceps, lot # L028280 (expiration date was not reported). There was no illness at the time of vaccination. On 16-OCT-2015, 4 days after receiving ZOSTAVAX, the patient experienced Flu-like symptoms, headache, body aches and fatigue, all of which lasted 3 full days. For the next 2 days, the patient felt a bit better and on approximately 21-OCT-2015 (reported as "2 days later"), fatigue and headache returned and she developed skin soreness, which increased over the next 72 hours. Then on approximately 24-OCT-2015, the patient developed a rash on her left side waist area, abdomen, and back. On 27-OCT-2015, the patient visited her physician who diagnosed the patient being confirmed to having shingles. There were no lab diagnostic studies performed. The patient was given valacyclovir 1g three times a day for 10 days as a treatment for the event. On an unknown date in 2015, the patient recovered from shingles. The relatedness between the event and ZOSTAVAX was not provided. The reporting pharmacist considered the event to be serious as a significant disability to the patient because she was "severely suffering" as a result. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Emotional distress, Fatigue, Headache, Herpes zoster, Influenza like illness
Clinical narrative: This spontaneous report was received from a pharmacist concerning a 63-year-old female patient with no allergies and pre-existing medical conditions. On 12-OCT-2015 at 15:53, the patient was vaccinated with the first dose of ZOSTAVAX 0.65 ml, once, subcutaneously in the arm near triceps, lot # L028280 (expiration date was not reported). There was no illness at the time of vaccination. On 16-OCT-2015, 4 days after receiving ZOSTAVAX, the patient experienced Flu-like symptoms, headache, body aches and fatigue, all of which lasted 3 full days. For the next 2 days, the patient felt a bit better and on approximately 21-OCT-2015 (reported as "2 days later"), fatigue and headache returned and she developed skin soreness, which increased over the next 72 hours. Then on approximately 24-OCT-2015, the patient developed a rash on her left side waist area, abdomen, and back. On 27-OCT-2015, the patient visited her physician who diagnosed the patient being confirmed to having shingles. There were no lab diagnostic studies performed. The patient was given valacyclovir 1g three times a day for 10 days as a treatment for the event. On an unknown date in 2015, the patient recovered from shingles. The relatedness between the event and ZOSTAVAX was not provided. The reporting pharmacist considered the event to be serious as a significant disability to the patient because she was "severely suffering" as a result. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain, Pain of skin, Rash
Clinical narrative: This spontaneous report was received from a pharmacist concerning a 63-year-old female patient with no allergies and pre-existing medical conditions. On 12-OCT-2015 at 15:53, the patient was vaccinated with the first dose of ZOSTAVAX 0.65 ml, once, subcutaneously in the arm near triceps, lot # L028280 (expiration date was not reported). There was no illness at the time of vaccination. On 16-OCT-2015, 4 days after receiving ZOSTAVAX, the patient experienced Flu-like symptoms, headache, body aches and fatigue, all of which lasted 3 full days. For the next 2 days, the patient felt a bit better and on approximately 21-OCT-2015 (reported as "2 days later"), fatigue and headache returned and she developed skin soreness, which increased over the next 72 hours. Then on approximately 24-OCT-2015, the patient developed a rash on her left side waist area, abdomen, and back. On 27-OCT-2015, the patient visited her physician who diagnosed the patient being confirmed to having shingles. There were no lab diagnostic studies performed. The patient was given valacyclovir 1g three times a day for 10 days as a treatment for the event. On an unknown date in 2015, the patient recovered from shingles. The relatedness between the event and ZOSTAVAX was not provided. The reporting pharmacist considered the event to be serious as a significant disability to the patient because she was "severely suffering" as a result. Additional information has been requested.
Age: 39.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Blood thyroid stimulating hormone normal, Borrelia test negative, Burning sensation, C-reactive protein normal, Epstein-Barr virus test negative
Clinical narrative: This medically confirmed spontaneous report (initial receipt 29-Oct-2015) concerns a 39 year-old female patient. Concomitant medications included multivitamins and fluvoxamine maleate. She received bioCSL's Afluria (prefilled syringe) last year and was fine (experienced no reaction). On 08-Oct-2015, the patient received Afluria injection (Influenza virus vaccine polyvalent, batch number 10949221A [thiomersal containing]) 0.5 mL annually via the intramuscular route for the prevention of influenza. On 15-Oct-2015, the patient began to experience redness, pain and burning on the left and right sides of her hands and feet. The reaction was painful in which she could not touch a pen to sign, and she had to change out of her normal shoes to ease the pain. She also had to leave work early. On 16-Oct-2015, the patient visited the doctor and got various blood works done, including CBC (complete blood count), Lyme, mononucleosis and sedimentation rate. All her blood work was normal.  She had consulted her doctor and pharmacist about this.  No treatments taken for her symptoms. The reporter stated her skin was peeling now. The outcome was not yet recovered. Reporter's Comments: Reporter's comments: The reporter believed that the reaction was due to the additive, thimerosal, in the multidose vials as this has happened to her before. She states that prior to last year, she received a multidose vial (non-bioCSL product, unknown manufacturer) which contained the additive and she experienced the same reaction. She had no changes in her medication regimen. The first time the first reaction occurred and she took Benadryl (diphenhydramine) which didn't help. Sender's Comments: Company comments: Seriousness criterion/criteria: Medically significant. Listedness: Unlisted. Assessment according to the CCDS for CSL Inactivated Influenza Virus Vaccine and the Afluria PI, all events are unlisted. Causality: Possible. Time to event onset is 8 days of vaccination. Investigations for EBV and Lyme's disease, ESR were negative. Patient had not commenced any new medication. One of the well-known cause of palmar plantar erythema is reaction to cytotoxic chemotherapies which was not the case in this patient. Of note patient had similar reaction to IVV from MDV in past. Due to temporal association, vaccination is causally attributable.
Age: 39.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Erythema, Full blood count normal, Liver function test normal, Metabolic function test normal, Mononucleosis heterophile test negative
Clinical narrative: This medically confirmed spontaneous report (initial receipt 29-Oct-2015) concerns a 39 year-old female patient. Concomitant medications included multivitamins and fluvoxamine maleate. She received bioCSL's Afluria (prefilled syringe) last year and was fine (experienced no reaction). On 08-Oct-2015, the patient received Afluria injection (Influenza virus vaccine polyvalent, batch number 10949221A [thiomersal containing]) 0.5 mL annually via the intramuscular route for the prevention of influenza. On 15-Oct-2015, the patient began to experience redness, pain and burning on the left and right sides of her hands and feet. The reaction was painful in which she could not touch a pen to sign, and she had to change out of her normal shoes to ease the pain. She also had to leave work early. On 16-Oct-2015, the patient visited the doctor and got various blood works done, including CBC (complete blood count), Lyme, mononucleosis and sedimentation rate. All her blood work was normal.  She had consulted her doctor and pharmacist about this.  No treatments taken for her symptoms. The reporter stated her skin was peeling now. The outcome was not yet recovered. Reporter's Comments: Reporter's comments: The reporter believed that the reaction was due to the additive, thimerosal, in the multidose vials as this has happened to her before. She states that prior to last year, she received a multidose vial (non-bioCSL product, unknown manufacturer) which contained the additive and she experienced the same reaction. She had no changes in her medication regimen. The first time the first reaction occurred and she took Benadryl (diphenhydramine) which didn't help. Sender's Comments: Company comments: Seriousness criterion/criteria: Medically significant. Listedness: Unlisted. Assessment according to the CCDS for CSL Inactivated Influenza Virus Vaccine and the Afluria PI, all events are unlisted. Causality: Possible. Time to event onset is 8 days of vaccination. Investigations for EBV and Lyme's disease, ESR were negative. Patient had not commenced any new medication. One of the well-known cause of palmar plantar erythema is reaction to cytotoxic chemotherapies which was not the case in this patient. Of note patient had similar reaction to IVV from MDV in past. Due to temporal association, vaccination is causally attributable.
Age: 39.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Oestradiol normal, Pain in extremity, Red blood cell sedimentation rate normal, Rheumatoid factor negative, Skin exfoliation
Clinical narrative: This medically confirmed spontaneous report (initial receipt 29-Oct-2015) concerns a 39 year-old female patient. Concomitant medications included multivitamins and fluvoxamine maleate. She received bioCSL's Afluria (prefilled syringe) last year and was fine (experienced no reaction). On 08-Oct-2015, the patient received Afluria injection (Influenza virus vaccine polyvalent, batch number 10949221A [thiomersal containing]) 0.5 mL annually via the intramuscular route for the prevention of influenza. On 15-Oct-2015, the patient began to experience redness, pain and burning on the left and right sides of her hands and feet. The reaction was painful in which she could not touch a pen to sign, and she had to change out of her normal shoes to ease the pain. She also had to leave work early. On 16-Oct-2015, the patient visited the doctor and got various blood works done, including CBC (complete blood count), Lyme, mononucleosis and sedimentation rate. All her blood work was normal.  She had consulted her doctor and pharmacist about this.  No treatments taken for her symptoms. The reporter stated her skin was peeling now. The outcome was not yet recovered. Reporter's Comments: Reporter's comments: The reporter believed that the reaction was due to the additive, thimerosal, in the multidose vials as this has happened to her before. She states that prior to last year, she received a multidose vial (non-bioCSL product, unknown manufacturer) which contained the additive and she experienced the same reaction. She had no changes in her medication regimen. The first time the first reaction occurred and she took Benadryl (diphenhydramine) which didn't help. Sender's Comments: Company comments: Seriousness criterion/criteria: Medically significant. Listedness: Unlisted. Assessment according to the CCDS for CSL Inactivated Influenza Virus Vaccine and the Afluria PI, all events are unlisted. Causality: Possible. Time to event onset is 8 days of vaccination. Investigations for EBV and Lyme's disease, ESR were negative. Patient had not commenced any new medication. One of the well-known cause of palmar plantar erythema is reaction to cytotoxic chemotherapies which was not the case in this patient. Of note patient had similar reaction to IVV from MDV in past. Due to temporal association, vaccination is causally attributable.
Age: 39.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Vitamin B12 normal, Vitamin D
Clinical narrative: This medically confirmed spontaneous report (initial receipt 29-Oct-2015) concerns a 39 year-old female patient. Concomitant medications included multivitamins and fluvoxamine maleate. She received bioCSL's Afluria (prefilled syringe) last year and was fine (experienced no reaction). On 08-Oct-2015, the patient received Afluria injection (Influenza virus vaccine polyvalent, batch number 10949221A [thiomersal containing]) 0.5 mL annually via the intramuscular route for the prevention of influenza. On 15-Oct-2015, the patient began to experience redness, pain and burning on the left and right sides of her hands and feet. The reaction was painful in which she could not touch a pen to sign, and she had to change out of her normal shoes to ease the pain. She also had to leave work early. On 16-Oct-2015, the patient visited the doctor and got various blood works done, including CBC (complete blood count), Lyme, mononucleosis and sedimentation rate. All her blood work was normal.  She had consulted her doctor and pharmacist about this.  No treatments taken for her symptoms. The reporter stated her skin was peeling now. The outcome was not yet recovered. Reporter's Comments: Reporter's comments: The reporter believed that the reaction was due to the additive, thimerosal, in the multidose vials as this has happened to her before. She states that prior to last year, she received a multidose vial (non-bioCSL product, unknown manufacturer) which contained the additive and she experienced the same reaction. She had no changes in her medication regimen. The first time the first reaction occurred and she took Benadryl (diphenhydramine) which didn't help. Sender's Comments: Company comments: Seriousness criterion/criteria: Medically significant. Listedness: Unlisted. Assessment according to the CCDS for CSL Inactivated Influenza Virus Vaccine and the Afluria PI, all events are unlisted. Causality: Possible. Time to event onset is 8 days of vaccination. Investigations for EBV and Lyme's disease, ESR were negative. Patient had not commenced any new medication. One of the well-known cause of palmar plantar erythema is reaction to cytotoxic chemotherapies which was not the case in this patient. Of note patient had similar reaction to IVV from MDV in past. Due to temporal association, vaccination is causally attributable.
Age: 39.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Borrelia test negative, Burning sensation, Erythema, Full blood count normal, Impaired work ability
Clinical narrative: This medically confirmed spontaneous report (initial receipt 29-Oct-2015) concerns a 39 year-old female patient. Concomitant medications included multivitamins and fluvoxamine maleate. She received bioCSL's Afluria (prefilled syringe) last year and was fine (experienced no reaction). On 08-Oct-2015, the patient received Afluria injection (Influenza virus vaccine polyvalent, batch number 10949221A [thiomersal containing]) 0.5 mL annually via the intramuscular route for the prevention of influenza. On 15-Oct-2015, the patient began to experience redness, pain and burning on the left and right sides of her hands and feet. The reaction was painful in which she could not touch a pen to sign, and she had to change out of her normal shoes to ease the pain. She also had to leave work early. On 16-Oct-2015, the patient visited the doctor and got various blood works done, including CBC (complete blood count), Lyme, mononucleosis and sedimentation rate. All her blood work was normal.  She had consulted her doctor and pharmacist about this.  No treatments taken for her symptoms. The reporter stated her skin was peeling now. The outcome was not yet recovered. Reporter's Comments: Reporter's comments: The reporter believed that the reaction was due to the additive, thimerosal, in the multidose vials as this has happened to her before. She states that prior to last year, she received a multidose vial (non-bioCSL product, unknown manufacturer) which contained the additive and she experienced the same reaction. She had no changes in her medication regimen. The first time the first reaction occurred and she took Benadryl (diphenhydramine) which didn't help. Sender's Comments: Company comments: Seriousness criterion/criteria: Medically significant. Listedness: Unlisted. Assessment according to the CCDS for CSL Inactivated Influenza Virus Vaccine and the Afluria PI, all events are unlisted. Causality: Possible. Time to event onset is 8 days of vaccination. Investigations for EBV and Lyme's disease, ESR were negative. Patient had not commenced any new medication. One of the well-known cause of palmar plantar erythema is reaction to cytotoxic chemotherapies which was not the case in this patient. Of note patient had similar reaction to IVV from MDV in past. Due to temporal association, vaccination is causally attributable.