chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Chest pain, Dyspnoea, Headache
Clinical narrative: This spontaneous report was received from a physician through a former medical affairs director via a company representative concerning a 15 year old female patient. No concurrent conditions or medical history were reported. On 11-JUL-2014, the patient was vaccinated with the first dose and the only injection of GARDASIL (Lot No., dose, route and anatomical location of administration were not reported). No concomitant therapy was provided. On approximately 11-JUL-2014, reported as "since the GARDASIL was administered", the patient experienced intermittent shortness of breath and chest pains. On 12-JUL-2014, reported also as "the day after the GARDASIL was administered", the patient experienced a headache every day. The headache were severe on some days. No Product Quality Complaint (PQC) was involved. The outcome of dyspnoea, headache and chest pain was unknown. 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 healthcare worker referring to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions/allergies were not reported. On 27-JAN-2016, the patient was vaccinated with a dose of ROTATEQ (lot # L013192 and expiration date January 2017, oral), which was exposed to temperatures outside of the recommended range. There were no concomitant medications provided. No adverse effects were reported. This is one of several reports received 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 as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history or concurrent conditions was provided. On unknown dates, the patients were vaccinated with improperly stored doses of VAQTA injection (lot # L023232, expiry date 27-FEB-2017). There were no concomitant therapies reported. The medical assistant stated that the doses of the vaccines were exposed to a temperature excursion for a cumulative time of 2.5 hours (2 hours 27 minutes) at a temperature of -0.1 degrees Celsius. There was no previous temperature excursion involved. No adverse effect was reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to an unknown number of patients of unknown age and gender. The patients' concurrent conditions and medical history were not reported. In approximately February 2016 (reported as "since 10-FEB-2016"), the patients were vaccinated with improperly stored doses of M-M-R II lot # K024825 with expiration date: 02-DEC-2016 and lot # L005291 with expiration date: 17-FEB-2017 (exact dose, dose number, therapy type, route of administration and anatomical location were not reported). There were no concomitant medications provided. Administered doses of vaccines experienced the temperature excursion of 48.7 degrees Fahrenheit for 30 minutes. There were no previous temperature excursion. There were no adverse effects reported. This is one of the several reports received 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 registered nurse and refers to an unknown number of patients of unknown age and gender. The patients' concurrent conditions and medical history were not reported. In approximately February 2016 (reported as "since 10-FEB-2016"), the patients were vaccinated with improperly stored doses of oral, ROTATEQ lot # K019370 with expiration date: 16-JUL-2016 and lot # L027070 and expiration date 30-APR-2017, orally (exact dose, and dose number were not reported). There were no concomitant medications provided. Administered doses of vaccines experienced the temperature excursion of 48.7 degrees Fahrenheit for 30 minutes. There were no previous temperature excursion. There were no adverse effects reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history or concurrent conditions was provided. On unknown dates, the patients were vaccinated with improperly stored doses of PEDVAXHIB injection (lot# L030870, expiry date 10-JUN-2016; lot# L030867, expiry date 09-JUN-2018 and lot# L038501, expiry date 16-AUG-2018; exact dose and route of administration were not reported). There were no concomitant therapies reported. The medical assistant stated that the doses of the vaccine were exposed to a temperature excursion for a cumulative time of 2.5 hours (2 hours 27 minutes) at a temperature of -0.1 degrees Celsius. There was no previous temperature excursion involved. No adverse effect was reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. 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 healthcare professional referring to unspecified patient of unknown age or gender. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patients were vaccinated with 2 improperly stored doses of GARDASIL (dose, anatomical location or frequency were unknown) lot # K004205, expiration date: 12-JAN-2017. No adverse effects reported. No product quality issues informed. This is one of two reports 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 healthcare professional referring to unspecified patient of unknown age or gender. The patients' medical history and concurrent conditions were not reported. On an unknown date, the patients were vaccinated with 2 improperly stored (temperature 31.7 F, time frame: 19 hours and 40 minutes) doses of oral, ROTATEQ (dose, anatomical location or frequency were unknown) lot # L013206, expiration date: 29-JAN-2017. No adverse effects reported. No product quality issue informed. This is one of two reports 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 a healthcare worker referring to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions/allergies were not reported. On 16-FEB-2016, the patient was vaccinated with a dose of VAQTA (lot # L002717 and expiration date June 2017, unknown route), which was exposed to temperatures outside of the recommended range. There were no concomitant medications provided. No adverse effects were reported. This is one of several reports received from the same reporter. 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 medical assistant refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history or concurrent conditions was provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 injection (lot# L018351, expiry date 11-AUG-2017 and lot# L024993, expiry date 17-OCT-2017; exact dose and route of administration were not reported). There were no concomitant therapies reported. The medical assistant stated that the doses of the vaccine were exposed to a temperature excursion for a cumulative time of 2.5 hours (2 hours 27 minutes) at a temperature of -0.1 degrees Celsius. There was no previous temperature excursion involved. No adverse effect was reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Rash
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to an unspecified patient of unknown age and gender. The patient's medical history included shingles. On an unknown date the patient was vaccinated with a dose of PROQUAD (Merck) (dose and lot # not reported). On an unknown date, reported as "within a week or so", the patient experienced an unspecified rash on an unspecified location of their body. The outcome of rash was unknown. The relatedness between vaccination with a dose of PROQUAD (Merck) and rash was not reported. This is one of several reports received from the same source. Additional information is not expected, physician disagreed to be contacted.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to unspecified number of patients of unknown ages and genders. There were not concurrent conditions and medical history reported. On an unknown date, the patients were vaccinated with unspecified and improperly stored doses of VARIVAX (Merck) lot numbers L025210, L017998, L020002, L026406, L034368 and expiration dates 07-JUL-2017, 19-MAY-2017, 02-JUN-2017, 15-JUL-2017 and 08-SEP-2017 respectively (route, dose, dose number and anatomical place of vaccination were not provided). No adverse effects were reported. Temperature/ time frame: 30-JAN-2016 -14 degrees C for 4 hours; 01-FEB-2016 -14 degrees C for 44 hours and -12 degrees C for 9 hours; 02-FEB-2016 -11 degrees C for 15 hours; -10 degrees C for 9 hours; 03-FEB-2016 -9 degrees C for 15 hours and -8 degrees C for 9 hours; 04-FEB-2016 -7 degrees C for 15 hours and -6 degrees C for 9 hours; 05-FEB-2016 -5 degrees C for 15 hours and -4 degrees C for 9 hours; 08-FEB-2016 -3 degrees C for 63 hours. Cumulative -10 degrees C to -14 degrees C for 81 hours (unlimited range) and cumulative -9 degrees C for 135 hours. No previous temperature excursion. No product quality complaint was involved. This is one of several reports received from the same source. 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 registered nurse referring to unspecified number of patients of unknown ages and genders. There were not concurrent conditions and medical history reported. On an unknown date, the patients were vaccinated with unspecified and improperly stored doses of PROQUAD (Merck) lot numbers L040414 expiration date 13-APR-2017, albumin status rHA and L033697 expiration date 28-FEB-2017, albumin status rHA (route, dose, dose number and anatomical place of vaccination were not provided). No adverse effects were reported. Temperature/time frame: 30-JAN-2016 -14 degrees C for 4 hours; 01-FEB-2016 -14 degrees C for 44 hours and -12 degrees C for 9 hours; 02-FEB-2016 -11 degrees C for 15 hours; -10 degrees C for 9 hours; 03-FEB-2016 -9 degrees C for 15 hours and -8 degrees C for 9 hours; 04-FEB-2016 -7 degrees C for 15 hours and -6 degrees C for 9 hours; 05-FEB-2016 -5 degrees C for 15 hours and -4 degrees C for 9 hours; 08-FEB-2016 -3 degrees C for 63 hours. Cumulative -10 degrees C to -14 degrees C for 81 hours (unlimited range) and cumulative -9 degrees C to -3 degrees C for 135 hours. No previous temperature excursion. No product quality complaint was involved. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to unspecified number of patients of unknown ages and genders. There were not concurrent conditions and medical history reported. On an unknown date, the patients were vaccinated with unspecified and improperly stored doses of ZOSTAVAX lot number L032403 expiration date 26-NOV-2016 and L023118 expiration date 24-SEP-2016 (route, dose, dose number and anatomical place of vaccination were not provided). No adverse effects were reported. Temperature/time frame: 30-JAN-2016 - 14 degrees C for 4 hours; 01-FEB-2016 -14 degrees C for 44 hours and -12 degrees C for 9 hours; 02-FEB-2016 -11 degrees C for 15 hours; -10 degrees C for 9 hours; 03-FEB-2016 -9 degrees C for 15 hours and -8 degrees C for 9 hours; 04-FEB-2016 -7 degrees C for 15 hours and -6 degrees C for 9 hours; 05-FEB-2016 -5 degrees C for 15 hours and -4 degrees C for 9 hours; 08-FEB-2016 -3 degrees C for 63 hours. Cumulative -10 degrees C to -14 degrees C for 81 hours (unlimited ranged) and cumulative -9 degrees C to -3 degrees C for 135 hours. No previous temperature excursion. No product quality complaint was involved. This is one of several reports received from the same source. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Arthralgia, Blood creatinine increased, Cough, Migraine, Myalgia
Clinical narrative: Information has been received from a 62 year old female consumer via Pfizer (other manufacturer # 2016108223) concerning herself, who had breast cancer since 1999. Historical drug included OXYCONTIN for 18 year for back pain. She underwent a mastectomy in June 1999, then 4-5 surgeries after that to change her implant. Blood clot occurred after one of her reconstruction surgeries, when an implant had to be changed. In approximately 2004 (reported as 12 years ago), the patient underwent knee replacement. In November 2015, a nerve test showed nerve damage. On 04-JAN-2016, the patient had kidney issues and was hospitalized, the creatinine level was high at 7.7 (unit not provided). The patient and her siblings had no adverse event following prior vaccinations. On 05-JAN-2016 morning (time unspecified), while the patient was in the hospital, a nurse came in her room and asked if she wanted the pneumonia shot. The patient thought she was over 60 year old and was vaccinated with PNEUMOVAX 23 (lot #, dose and route unknown) probable in the right arm. On the same day the patient also concomitantly received the first dose of Tdap injection (manufacturer unknown) in stomach. There were no any other vaccinations within four weeks prior to date listed. Concomitant therapies included AGGRENOX for blood clot, MS CONTIN for back pain, LUNESTA for sleeping, FLEXERIL for muscle relaxer for back, VALSARTAN HCT  for blood pressure and gabapentin for nerve damage in right leg and omeprazole. On 07-JAN-2016, the patient discharged from the hospital. On 08-JAN-2016 or 09-JAN-2016, the patient started experiencing constant headaches like migraine, joint and muscle pain, coughing and sneezing. On approximately 11-FEB-2016 (reported as last Monday), the patient went to her doctor mentioned headaches. Headaches like migraines, joint and muscle pain were ongoing and worsened. Coughing and sneezing were persisting. The causality of the events and suspect vaccine was not provided. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Nerve stimulation test abnormal, Renal disorder, Sneezing
Clinical narrative: Information has been received from a 62 year old female consumer via Pfizer (other manufacturer # 2016108223) concerning herself, who had breast cancer since 1999. Historical drug included OXYCONTIN for 18 year for back pain. She underwent a mastectomy in June 1999, then 4-5 surgeries after that to change her implant. Blood clot occurred after one of her reconstruction surgeries, when an implant had to be changed. In approximately 2004 (reported as 12 years ago), the patient underwent knee replacement. In November 2015, a nerve test showed nerve damage. On 04-JAN-2016, the patient had kidney issues and was hospitalized, the creatinine level was high at 7.7 (unit not provided). The patient and her siblings had no adverse event following prior vaccinations. On 05-JAN-2016 morning (time unspecified), while the patient was in the hospital, a nurse came in her room and asked if she wanted the pneumonia shot. The patient thought she was over 60 year old and was vaccinated with PNEUMOVAX 23 (lot #, dose and route unknown) probable in the right arm. On the same day the patient also concomitantly received the first dose of Tdap injection (manufacturer unknown) in stomach. There were no any other vaccinations within four weeks prior to date listed. Concomitant therapies included AGGRENOX for blood clot, MS CONTIN for back pain, LUNESTA for sleeping, FLEXERIL for muscle relaxer for back, VALSARTAN HCT  for blood pressure and gabapentin for nerve damage in right leg and omeprazole. On 07-JAN-2016, the patient discharged from the hospital. On 08-JAN-2016 or 09-JAN-2016, the patient started experiencing constant headaches like migraine, joint and muscle pain, coughing and sneezing. On approximately 11-FEB-2016 (reported as last Monday), the patient went to her doctor mentioned headaches. Headaches like migraines, joint and muscle pain were ongoing and worsened. Coughing and sneezing were persisting. The causality of the events and suspect vaccine was not provided. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse concerning a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not provided. On 29-FEB-2016, the patient was vaccinated with an improperly stored dose of MMR II, lot# reported as L027432, expiration date 22-JUL-2017 (dose and route not reported), which was exposed to 10 degree centigrade temperature for 60 hours. There was no previous temperature excursion. No adverse event was reported. It was also reported that GARDASIL, GARDASIL 9 and LIQUID PEDVAXHIB were involved in the excursion but were not administered. 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 healthcare worker referring to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions/allergies were not reported. On 28-JAN-2016, the patient was vaccinated with a dose of ROTATEQ (lot # L013192 and expiration date January 2017, oral), which was exposed to temperatures outside of the recommended range. There were no concomitant medications provided. No adverse effects were reported. This is one of several reports received 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 healthcare worker referring to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions/allergies were not reported. On 28-JAN-2016, the patient was vaccinated with dose of ROTATEQ (lot # L013192 and expiration date January 2017, oral), which was exposed to temperatures outside of the recommended range. There were no concomitant medications provided. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4, MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician and a Medical Assistance referring to a patient of unknown age and unknown gender. The patient's concurrent conditions and medical history were not reported. On an unknown date the patient was vaccinated with a dose of GARDASIL (Lot No L040459; Expiration date 06-APR-2017) (dose, and route was not provided). Concomitant therapies included M-M-R II (Lot No: L24268; expiration date: 01-JUL-2017). The physician reported that the patient received improperly stored GARDASIL. The vaccine was improperly stored for a time frame of 17.5 hours. There was not previous temperature excursion. No adverse effects were reported. The M-M-R II remained in recommended storage range. This is one of several reports from the same source. 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 healthcare worker referring to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions/allergies were not reported. On 28-JAN-2016, the patient was vaccinated with a dose of ROTATEQ (lot # L013192 and expiration date January 2017, oral), which was exposed to temperature outside of the recommended range. There were no concomitant medications provided. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 17.0
Sex: M
Vaccine: MMRV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare professional referring to a 17 year old patient of unknown gender. The patient's concurrent and historical conditions were not provided. On 08-FEB-2016, the patient was vaccinated with PROQUAD (Merck) (lot number and expiration date were not provided) dose, route were not reported; which was outside of the recommendations in the PROQUAD (Merck) prescribed information (inappropriate schedule of drug administration). No concomitant medications were provided. No adverse effects were reported. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: TDAP
Symptoms: Arthralgia, Headache, Pyrexia, Vaccination site erythema, Vaccination site induration
Clinical narrative: Vaccination site (L) deltoid edematous erythema, (large area of upper arm, hot to touch, large area of induration, pt reports having fever of 105 degrees F x one night with h/a, joint pain. Onset of symptoms 02/29/16 to present. Fever x one night.
Sex: U
Vaccine: TDAP
Symptoms: Vaccination site oedema, Vaccination site warmth
Clinical narrative: Vaccination site (L) deltoid edematous erythema, (large area of upper arm, hot to touch, large area of induration, pt reports having fever of 105 degrees F x one night with h/a, joint pain. Onset of symptoms 02/29/16 to present. Fever x one night.
Age: 53.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Left upper arm 5cm red, indurated, warm, central firmness.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Swelling, induration, redness around injection site 10-15 cm area within 12-24 hours. Improved after 2 days no fever or constitutional symptoms.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker referring to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions/allergies were not reported. On 02-FEB-2016, the patient was vaccinated with a dose of oral, ROTATEQ (lot # L013192 and expiration date January 2017), which was exposed to temperatures outside of the recommended range. There were no concomitant medications provided. No adverse effects were reported. This is one of several reports received 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 healthcare worker referring to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions/allergies were not reported. On 01-FEB-2016, the patient was vaccinated with a dose of oral, ROTATEQ (lot # L013192 and expiration date January 2017), which was exposed to temperatures outside of the recommended range. There were no concomitant medications provided. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HEP
Symptoms: Lip injury, Syncope
Clinical narrative: Patient fainted after receiving the vaccine. Cut lip on tooth. Had previous syncope w/tetanus vaccine, but not with others, like flu.
Age: 60.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Cellulitis, Peripheral swelling, Skin warm, Urticaria
Clinical narrative: Case number PHHY2016US006266, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 606684) website on 18 Jan 2016. This report refers to a 60 years old female patient. Past medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 158301) intramuscularly into left arm along with ZOSTAVAX (other manufacturer and batch number: L026415) subcutaneously in right arm both on 24 Oct 2015. On 27 Oct 2015, she had a welt on arm, very warm and swollen which the physician suspected as cellulitis. She visited emergency room and was treated with antibiotics (unspecified) and prednisone (manufacturer unknown). The final outcome of the events was unknown. The seriousness of the events was reported as non serious. The causality of the events was not reported. The seriousness assessment of the event cellulitis was upgraded to medically significant based on the Novartis Important Medical Event List. The seriousness assessment of the events peripheral swelling and skin warm was upgraded to medically significant based on the source document. Batch review report (reference number (1011502) received from quality assurance department on 23 Feb 2016: Based on the document review, it was stated that the concerned FLUVIRIN batch number (158301) was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. No anomalies were noted during this review. Non significant follow up report received from a Quality Assurance department (QA reference number: 1011502) on 28 Jan 2016: QA reference number updated only. Significant follow up received from the quality assurance department (QA, reference number: 1011502) on 23 Feb 2016: Updated expanded batch review report.
Age: 11.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Gait disturbance, Musculoskeletal stiffness, Nausea
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of nausea in a 11-year-old female patient who received BOOSTRIX (batch number 5SR2L, expiry date 18th December 2016). On 27th January 2016, the patient received BOOSTRIX .5 ml. On 30th January 2016, 3 days after receiving BOOSTRIX, the patient experienced nausea, walking difficulty, fever and limbs stiffness. On an unknown date, the outcome of the nausea, walking difficulty, fever and limbs stiffness were recovering/resolving. It was unknown if the reporter considered the nausea, walking difficulty, fever and limbs stiffness to be related to BOOSTRIX. Additional details provided were as follows: The patient experienced stiffness in the legs and trouble walking. At the time of reporting, the events were improving. No doctor's visit or medical intervention was required.
Age: 11.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Gait disturbance, Musculoskeletal stiffness, Nausea, Pyrexia
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of nausea in a 11-year-old female patient who received BOOSTRIX (batch number 5SR2L, expiry date 18th December 2016). On 27th January 2016, the patient received BOOSTRIX .5 ml. On 30th January 2016, 3 days after receiving BOOSTRIX, the patient experienced nausea, walking difficulty, fever and limbs stiffness. On an unknown date, the outcome of the nausea, walking difficulty, fever and limbs stiffness were recovering/resolving. It was unknown if the reporter considered the nausea, walking difficulty, fever and limbs stiffness to be related to BOOSTRIX. Additional details provided were as follows: The patient experienced stiffness in the legs and trouble walking. At the time of reporting, the events were improving. No doctor's visit or medical intervention was required.
Age: 1.56
Sex: F
Vaccine: HEPA
Symptoms: Decreased appetite, Vomiting
Clinical narrative: After having the hepatitis A shot my daughter vomited in the evening on 3/01/16 and did not have any appetite for food in the afternoon of 3/01/16 and all the following day. I am submitting this report on 3/02/16 and I will be taking patient to the doctor next morning if she continue to have the symptoms.
Age: 0.82
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Diarrhoea, Rash erythematous, Viral infection, Vomiting
Clinical narrative: Based on the follow-up information received on 16 March 2015, this case became medically confirmed. Initial unsolicited report received from a consumer (Patient's mother) on 09 February 2015. A 09-month-old male patient, whose medical history and concomitant medications were not reported, had received a dose of Acthib and Daptacel (batch number, dose, dose in series, route of administration and site of administration were not reported for both vaccine) both on an 31 July 2008. On 01 August 2008 one day after vaccination, the patient experienced sunburn like rash with "flared up" areas and on 02 August 2008, two days after vaccination patient experienced diarrhea and vomiting. Laboratory investigations and corrective treatments were not reported. At the time of report the outcome of events were not reported. Documents held by sender: none. Follow-up information received from a physician on 16 March 2015. It was reported that it seems that this was an unrelated viral infection. The patient was vaccinated at private doctor's office/hospital. On unspecified date, the patient was recovered from the all the events. Documents held by sender: none.
Sex: F
Vaccine: MENB, MNQ
Symptoms: Erythema, Limb discomfort, Peripheral swelling
Clinical narrative: Initial unsolicited report received from a other health professional via other company (Pfizer, reference number 2016078040) on 18-FEB-2016. This case involves a female (age unknown) patient who was vaccinated with a dose of MENACTRA (batch number, expiry date, route and site of administration were not reported) and also received a dose of TRUMENBA (manufacturer Pfizer, batch number, expiry date, route and site of administration were not reported) on an unspecified date. Medical history and concomitant medications were not reported. On an unspecified date, following the vaccination patient developed lot of redness in flowing and discomfort in her arm and swelling. Laboratory investigation and corrective treatment were not reported. The outcome of event was not reported. Causality was reported as related. List of documents held by sender: none.
Age: 0.21
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Abnormal behaviour, Decreased eye contact
Clinical narrative: PARENTS REPORT INFANT REFUSING TO MAKE EYE CONTACT, NO LONGER COOING, OR TALKING AS MUCH AS BEFORE. MOM FEELS HE IS NOW GETTING BETTER- BUT NOT TO THE LEVEL HE WAS PRIOR TO VACCINES.
Age: 75.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Redness, swelling and itching at injection site.
Age: 5.0
Sex: M
Vaccine: FLU3
Symptoms: Dyskinesia, Syncope, Vomiting
Clinical narrative: Patient received flu vaccine went down to pharmacy had a syncopal event. Mom reported it was brief about a second or two pt jerked and vomited. Upon questioning mom she reported patient's sister had seizure similar to this after flu vaccine. Vitals taken within normal range.
Age: 71.0
Sex: M
Vaccine: TDAP
Symptoms: Anti-ganglioside antibody positive, Immunoglobulin therapy, Miller Fisher syndrome
Clinical narrative: Emergency room. Inpatient 2 days. Another hospital 7 days. Miller Fisher syndrome. Treatment = IVIG.
Age: 50.0
Sex: M
Vaccine: HEP
Symptoms: Chest pain, Hypoaesthesia
Clinical narrative: 01/07/2016 (L) hand numbness in the morning. Continue to reoccur for 1 month. 2/8/2016 numbness to face/chest pain continued for 2 day. Went to ER on 10 of Feb. Admitted for 1 day (obs). No cardiac issues. Patient reports, MD said it is possible it was due to Hep B vaccine.
Age: 66.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Burning sensation
Clinical narrative: Phone call from patient who states since she received the shingles shot her right arm and shoulder has "burned". Patient denies any redness, lump or rash at the site or any other location on her body. Patient states she has not gone to her Dr regarding the "burning" but thought she should notify Health Department since it may be related to the shingles shot. This nurse instructed patient to she her Doctor regarding the "burning" to rule out any other problems and to contact Health Department after she saw her Doctor and if Doctor thought the burning was from the shingles shot. Patient verbalized understanding.
Age: 53.0
Sex: F
Vaccine: HEP
Symptoms: Flushing, Headache, Rash
Clinical narrative: Aprox 15-20 min after vaccination with Hepatitis B (Merck) pt reported feeling flushed with headache.  Rash appeared on neck and chest.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Decreased appetite, Lethargy, Pain, Pyrexia
Clinical narrative: First sign was extreme swelling at VX site and got increasingly painful/I started feeling lethargic/at 8:30 I started with chills and felt like I had a fever. I took my temp and it was 102.5F. I was very sleepy and felt lethargic. On 2/27/2016 I woke up about 6:00AM and still had a fever of 102.6F and ached all over plus had no appetite at all. I slept on and off all day and my fever started to decline about 6 PM  I still felt very sore all over and lethargic but slightly improved.  Temp started down to about 101.6F. The next day 2/28/2016 I was feeling a little better when I awoke about 5 AM.  My fever had decreased to 100.6F. It was all uphill from there. I was completely normal feeling in the AM of 2/29/2016.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Somnolence, Vaccination site pain, Vaccination site swelling
Clinical narrative: First sign was extreme swelling at VX site and got increasingly painful/I started feeling lethargic/at 8:30 I started with chills and felt like I had a fever. I took my temp and it was 102.5F. I was very sleepy and felt lethargic. On 2/27/2016 I woke up about 6:00AM and still had a fever of 102.6F and ached all over plus had no appetite at all. I slept on and off all day and my fever started to decline about 6 PM  I still felt very sore all over and lethargic but slightly improved.  Temp started down to about 101.6F. The next day 2/28/2016 I was feeling a little better when I awoke about 5 AM.  My fever had decreased to 100.6F. It was all uphill from there. I was completely normal feeling in the AM of 2/29/2016.
Age: 59.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Herpes zoster, Immune system disorder, Pain in extremity, Rash
Clinical narrative: Soreness on left arm started on 27 Feb 16; rash developed on 28 Feb 16; rash started to spread on 28 Feb 16; physician determined that the rash was shingles due to weakened immune system.
Age: 20.0
Sex: M
Vaccine: HEPAB, IPV, TYP, YF
Symptoms: Dizziness, Dyspnoea, Erythema, Eye swelling, Ocular hyperaemia
Clinical narrative: POST VACCINES AND BICILLIN C/O n/v, felt light headed, shortest of breath, throat tightness, periobital redness/swelling and blotching to face and neck. tx; Epipen, Benadryl 50 mg, 125 mg Solumedrol.
Age: 20.0
Sex: M
Vaccine: HEPAB, IPV, TYP, YF
Symptoms: Rash macular, Throat tightness
Clinical narrative: POST VACCINES AND BICILLIN C/O n/v, felt light headed, shortest of breath, throat tightness, periobital redness/swelling and blotching to face and neck. tx; Epipen, Benadryl 50 mg, 125 mg Solumedrol.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal pain, Nerve conduction studies abnormal, Neuralgic amyotrophy, Nuclear magnetic resonance imaging normal, Periarthritis
Clinical narrative: Severe pain in right shoulder few days after vaccine, treated with prednisone for 6 days, referred to orthopedic doctor. He did x-ray and diagnosed me with frozen shoulder and referred me for physical therapy. After 3 weeks of therapy with no improvement, had MRI which showed no problem, then referred for nerve study and diagnosed with Parsonage-Turner syndrome.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: X-ray limb abnormal
Clinical narrative: Severe pain in right shoulder few days after vaccine, treated with prednisone for 6 days, referred to orthopedic doctor. He did x-ray and diagnosed me with frozen shoulder and referred me for physical therapy. After 3 weeks of therapy with no improvement, had MRI which showed no problem, then referred for nerve study and diagnosed with Parsonage-Turner syndrome.
Age: 50.0
Sex: F
Vaccine: FLUC3
Symptoms: Epstein-Barr virus antibody positive, Swelling face, VIIth nerve paralysis
Clinical narrative: Swollen face, right sided Bells palsy. Positive EBV after shot ~ 2 weeks.
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Hypersensitivity
Clinical narrative: Initial unsolicited report received from a Physician via other company (Pfizer, 2016078594) on 18-Feb-2016. This case involves a (age unknown) female patient who was vaccinated with a dose of INFLUENZA VACCINE (batch number, expiry date, route and site of administration were not reported)on an unspecified date. Medical history and concomitant medications were not reported. On an unspecified date, following the vaccination patient developed allergies. Laboratory investigation and corrective treatment were not reported. The outcome of event was not reported. List of documents held by sender: none.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Cough, Influenza, Malaise, Product quality issue, Respiratory tract congestion
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 63-year-old female patient who received FLUARIX QUADRIVALENT. This case was associated with a product complaint. On 18th November 2015, the patient received FLUARIX QUADRIVALENT. In December 2015, 30 days after receiving FLUARIX QUADRIVALENT, the patient experienced vaccination failure (serious criteria GSK medically significant), influenza, runny nose, cough and respiratory tract congestion. On an unknown date, the patient experienced pharmaceutical product complaint. On an unknown date, the outcome of the vaccination failure, influenza, runny nose, cough, respiratory tract congestion and pharmaceutical product complaint were unknown. The reporter considered the vaccination failure and influenza to be related to FLUARIX QUADRIVALENT. It was unknown if the reporter considered the runny nose, cough, respiratory tract congestion and pharmaceutical product complaint to be related to FLUARIX QUADRIVALENT. Additional details were received as follows: This case was not previously reported to anyone. The patient stated that, since receiving the FLUARIX QUADRIVALENT she had been sick twice, once in December (approximately one month after vaccination) and again at the time of reporting that is in February. The patient experienced the same symptoms each time, runny nose, cough, and chest congestion. The patient stated that, her husband received the same vaccination at a different pharmacy and has not been sick at all. The patient felt that, the vaccine she received was part of a bad batch. She did not have a physician and has not been seen by a health care provider for her symptoms. This case was considered as suspected vaccination failure case since, the time to onset of the events, the lab test confirmation for influenza and the exact details for the target disease were unknown.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Rhinorrhoea, Vaccination failure
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 63-year-old female patient who received FLUARIX QUADRIVALENT. This case was associated with a product complaint. On 18th November 2015, the patient received FLUARIX QUADRIVALENT. In December 2015, 30 days after receiving FLUARIX QUADRIVALENT, the patient experienced vaccination failure (serious criteria GSK medically significant), influenza, runny nose, cough and respiratory tract congestion. On an unknown date, the patient experienced pharmaceutical product complaint. On an unknown date, the outcome of the vaccination failure, influenza, runny nose, cough, respiratory tract congestion and pharmaceutical product complaint were unknown. The reporter considered the vaccination failure and influenza to be related to FLUARIX QUADRIVALENT. It was unknown if the reporter considered the runny nose, cough, respiratory tract congestion and pharmaceutical product complaint to be related to FLUARIX QUADRIVALENT. Additional details were received as follows: This case was not previously reported to anyone. The patient stated that, since receiving the FLUARIX QUADRIVALENT she had been sick twice, once in December (approximately one month after vaccination) and again at the time of reporting that is in February. The patient experienced the same symptoms each time, runny nose, cough, and chest congestion. The patient stated that, her husband received the same vaccination at a different pharmacy and has not been sick at all. The patient felt that, the vaccine she received was part of a bad batch. She did not have a physician and has not been seen by a health care provider for her symptoms. This case was considered as suspected vaccination failure case since, the time to onset of the events, the lab test confirmation for influenza and the exact details for the target disease were unknown.
Age: 79.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Skin warm
Clinical narrative: Localized redness about 1" x 2" with some heat.
Age: 60.0
Sex: M
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Joint range of motion decreased, Pain
Clinical narrative: Persistent pain immediately after injection unlike prior years flu shots. Pain continuing since injection date and worsening. Pain from 5-10 range with limited range of movement.
Age: 23.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Peripheral swelling, Vaccination complication
Clinical narrative: 3/3/16 2 days after vaccine pt. in clinic with left arm swelling and redness, per provider reaction to vaccine.
Age: 1.16
Sex: M
Vaccine: FLU4, HEPA, MMR, VARCEL
Symptoms: Febrile convulsion, Pyrexia, Seizure
Clinical narrative: On 3/1/16 (7 days after immunization) patient developed high fever and seizure -> dx with febrile seizure. Seen in office on 3/2/16 -> exam normal.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Dizziness, Pallor
Clinical narrative: Gave patient HPV (first dose) on right deltoid at 11:55 am and patient walked out of room feeling ok, after 1 minute pt. fell down dizzy and turned pale from her face, assisted patient and gave her water and a lollipop, after 20 minutes of being in office checked her blood pressure and was 105/65. Pt was stable and left stable and alert.
Age: 21.0
Sex: F
Vaccine: VARCEL
Symptoms: Ear swelling, Erythema, Injection site erythema, Injection site swelling, Pruritus
Clinical narrative: Redness and swelling at injection site - days later swollen ear and little red, itchy welt on back.
Age: 21.0
Sex: F
Vaccine: VARCEL
Symptoms: Urticaria
Clinical narrative: Redness and swelling at injection site - days later swollen ear and little red, itchy welt on back.
Sex: U
Vaccine: DTAP
Symptoms: Pruritus, Rash
Clinical narrative: This case was reported by a nurse via other manufacturer and described the occurrence of rash in a patient who received dTpa vaccine. On an unknown date, the patient received dTpa vaccine at an unknown dose. On an unknown date, an unknown time after receiving dTpa vaccine, the patient experienced rash and itching. On an unknown date, the outcome of the rash and itching were unknown. It was unknown if the reporter considered the rash and itching to be related to dTpa vaccine.
Age: 71.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Swelling; Redness; Tenderness.
Age: 71.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Erythema, Swelling, Tenderness
Clinical narrative: Swelling; Redness; Tenderness.
Age: 7.0
Sex: F
Vaccine: FLU4, IPV
Symptoms: Fall, Head injury, Muscle twitching, Pallor, Urinary incontinence
Clinical narrative: Pt. was given vaccine, walked to check out counter, fell back, hit head on floor. she was noted to be pale around lips and left hand was twitching. She also was incontinent with urine on the floor. Pt. came to in a few minutes and was transported to Emergency Room.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Biopsy muscle, Blood creatine phosphokinase increased, Electromyogram abnormal, Muscular weakness, Myositis
Clinical narrative: Muscle weakness, multiple myositis complaints. Myositis confirmed by EMG and muscle biopsy pending.
Age: 1.07
Sex: M
Vaccine: FLU4, HEPA, MMR, PNC13, VARCEL
Symptoms: Conjunctival hyperaemia, Eosinophil percentage increased, Full blood count, Haematocrit increased, Haemoglobin normal
Clinical narrative: Mother states that the patient developed fever 100.3 F and a generalized, erythematous rash, cephalocaudal spread, some conjunctival erythema and nasal congestion.
Age: 1.07
Sex: M
Vaccine: FLU4, HEPA, MMR, PNC13, VARCEL
Symptoms: Lymphocyte percentage, Measles antibody positive, Monocyte percentage increased, Mononucleosis heterophile test negative, Mycoplasma test
Clinical narrative: Mother states that the patient developed fever 100.3 F and a generalized, erythematous rash, cephalocaudal spread, some conjunctival erythema and nasal congestion.
Age: 1.07
Sex: M
Vaccine: FLU4, HEPA, MMR, PNC13, VARCEL
Symptoms: Nasal congestion, Neutrophil percentage decreased, Platelet count normal, Pyrexia, Rash erythematous
Clinical narrative: Mother states that the patient developed fever 100.3 F and a generalized, erythematous rash, cephalocaudal spread, some conjunctival erythema and nasal congestion.
Age: 1.07
Sex: M
Vaccine: FLU4, HEPA, MMR, PNC13, VARCEL
Symptoms: Rash generalised, Red blood cell sedimentation rate normal, White blood cell count normal
Clinical narrative: Mother states that the patient developed fever 100.3 F and a generalized, erythematous rash, cephalocaudal spread, some conjunctival erythema and nasal congestion.
Age: 1.57
Sex: F
Vaccine: FLU3, HEPA
Symptoms: Rash
Clinical narrative: Mother states rash appeared overnight; pt. febrile.
Age: 36.0
Sex: F
Vaccine: TDAP
Symptoms: Pain, Pyrexia
Clinical narrative: Fever (101.4F orally) taken at home and body aches.
Age: 66.0
Sex: M
Vaccine: HEPAB
Symptoms: Fatigue, Influenza like illness, Nausea, Pain
Clinical narrative: Patient reported feeling extremely fatigued and nauseated.  Described flu-like symptoms and body aches.
Age: 59.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Cold sweat, Hypotension, Pallor
Clinical narrative: Extreme hypotension, clammy skin, pale skin.