chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Initial information received on 26-Feb-2019 regarding an unsolicited valid non-serious case received from a physician by phone. This case involves adult patient of an unknown demographics who experienced arm pain, while received vaccine FLUZONE HIGH DOSE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported. On an unknown date in November, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (lot number, expiry date, dose, dose in series, route and site of administration were not reported). On an unknown date, the patient developed a non-serious arm pain (pain in extremity) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. No lab data was reported. Final diagnosis was arm pain. It was not reported if the patient received a corrective treatment.The patient outcome is not reported for arm pain. Documents held by the sender: none.
Sex: F
Vaccine: DTAPHEPBIP, HIBV, MMRV, PNC13
Symptoms: Expired product administered, No adverse event
Clinical narrative: Initial information received on 26-Feb-2019 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 23 months (also reported 1 year 11 months 25 days) old female patient who was vaccinated with an expired dose of ACT-HIB. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PEDIARIX; PREVNAR; and PROQUAD. On 22-Feb-2019, the patient received a dose of 0.5 ml suspect HIB (PRP/T) Vaccine) (Lypholized Powder: Lot: UI895AA, 27-Oct-2019, Diluent: Lot: U6001AA Exp date: 21-Feb-2019, Package: Lot: UI895AAA, Exp date: 21-Feb-2019) (dose in series and route was not reported) in the right thigh. It was a case of actual medication error due to expired vaccine used as ACTHIB was given on 22-Feb-2019 and the Diluent expired on 21-Feb-2019. No adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: Initial information received on 27-Feb-2019 regarding an unsolicited valid non-serious case received from a other health professional. This case is linked to case 2019SA059189 (same reporter). This case involves a 4 months old male patient who experienced received vaccine PENTACEL outside of the shipping standard. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PREVNAR for Immunisation; and ROTATEQ for Immunisation. On 26-Feb-2019, the patient received a 0.5 ml second dose injection of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot UJ065AAA (expiry date: 16-Oct-2020) via unknown route in the left thigh. It was a case of actual medication error due to incorrect product storage. The PENTACEL shipment was received 25-FEB-2019 and shipped on 20-FEB-2019. It was reported that no adverse event was experienced. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Rash macular, Skin warm, Swelling
Clinical narrative: Large raised, red, blotchy - larger than palm of mom's hand. Warm. No Fever.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: The mother of the patient relates that the day after the vaccination, when the child went back to school, she noticed that his left arm was red with an edema and hot to the touch at the site where the vaccine was administered the day before. The mother takes the patient to the primary physician Dr to get an evaluation of the affected area. Dr prescribe oral Benadryl and children Tylenol.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Monoplegia, Pain
Clinical narrative: Patient reports she was paralyzed from shoulder to arm and severe pain that started within hours of receiving vaccine and lasted a week and is still having pain 5 months later. She went to the emergency room and her primary care doctor for this reaction.
Age: 33.0
Sex: F
Vaccine: HPV9
Symptoms: Abdominal pain, Blood thyroid stimulating hormone normal, Burning sensation, Feeding disorder, Full blood count normal
Clinical narrative: I received the vaccine on 2/6/19. I started having severe abdominal pain on 2/10-11/19 where I was unable to eat but did not have nausea, vomiting, or diarrhea. Then my left arm started hurting on 2/20/19 and did not stop hurting. It started off as a deep aching that felt like someone had a 10 lb dumbbell on the upper part of my arm and then transitioned to L forearm pain and L hand numbness on 2/22/19. This then transitioned to L hand burning on 2/26/19 and went back to L arm aching/heaviness on 3/2/19 with some residual numbness and burning in the L hand at times. Currently L arm is still having aching pain/heaviness and feels tremulous at times and weaker than my R arm.
Age: 33.0
Sex: F
Vaccine: HPV9
Symptoms: Hypoaesthesia, Injection site pain, Limb discomfort, Metabolic function test normal, Muscular weakness
Clinical narrative: I received the vaccine on 2/6/19. I started having severe abdominal pain on 2/10-11/19 where I was unable to eat but did not have nausea, vomiting, or diarrhea. Then my left arm started hurting on 2/20/19 and did not stop hurting. It started off as a deep aching that felt like someone had a 10 lb dumbbell on the upper part of my arm and then transitioned to L forearm pain and L hand numbness on 2/22/19. This then transitioned to L hand burning on 2/26/19 and went back to L arm aching/heaviness on 3/2/19 with some residual numbness and burning in the L hand at times. Currently L arm is still having aching pain/heaviness and feels tremulous at times and weaker than my R arm.
Age: 33.0
Sex: F
Vaccine: HPV9
Symptoms: Pain in extremity, Red blood cell sedimentation rate normal, Tremor
Clinical narrative: I received the vaccine on 2/6/19. I started having severe abdominal pain on 2/10-11/19 where I was unable to eat but did not have nausea, vomiting, or diarrhea. Then my left arm started hurting on 2/20/19 and did not stop hurting. It started off as a deep aching that felt like someone had a 10 lb dumbbell on the upper part of my arm and then transitioned to L forearm pain and L hand numbness on 2/22/19. This then transitioned to L hand burning on 2/26/19 and went back to L arm aching/heaviness on 3/2/19 with some residual numbness and burning in the L hand at times. Currently L arm is still having aching pain/heaviness and feels tremulous at times and weaker than my R arm.
Age: 74.0
Sex: M
Vaccine: PPV
Symptoms: Rash, Urticaria
Clinical narrative: Rash, hives.
Age: 18.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a pharmacist concerning an unspecified patients of unknown age and gender. Information on the patient's concomitant medications, pertinent medical history and drug reactions or allergies was unknown. On an unknown date, the patients received an improperly stored dose of VARIVAX lot # R011806, expiry date 23-APR-2020 via subcutaneous route for prophylaxis. Temperature excursion was in the range of 15 degree Fahrenheit to 46 degree Fahrenheit for 12 hours. There was no previous temperature excursion. No adverse events was reported. No product quality complaint was involved. This is a non-valid case due to lack of patient identifiers. Follow-up information has been received from a pharmacist on 21-FEB-2019. The reporter stated that, there was one dose administered following the reported event. Patient identification information was unavailable at the time of the call. A request was made for patient identifiers, date of vaccinations, and if any adverse events had been reported. Upon receipt of follow-up information it was determined that this case is now valid because patient identifiers. Follow up information was received from pharmacist on 26-FEB-2019. This report refers 18 year old patient. It was discovered after the immunization was given that the vaccine was stored in a non-temperature monitored freezer from approx. 6 pm on 12-NOV-2018 to approximately 9 am on 13-NOV-2018. On 13-NOV-2018, the patient received VARIVAX. The reporter was contact to inquire about extended stability data for VARIVAX. It was estimated that the temperature range could have been anywhere from -5 to 20 degrees Fahrenheit (F). The patient did not experience any side effects. On 11-DEC-2018, the patient was returned to second dose of VARIVAX. The reporter had been trying to bring the patient back in to checks titers to make sure they are fully immunized.
Sex: U
Vaccine: MMR
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to a patient of unknown age and unknown gender. Information about pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medication was not reported. On 11-FEB-2019, the patient was vaccinated with a dose of M-M-R II (therapy type rHA, lot# R002510 with expiration date 25-JAN-2020, intradermally, dose detail and frequency was not reported) for prophylaxis (incorrect route of product administration). No adverse effects reported.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Haemorrhage, Pain in extremity, Peripheral swelling
Clinical narrative: This spontaneous report was received from a pharmacist via a company representative referring to a 58-year-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not provided. On 28-JAN-2019 the patient was vaccinated with a dose of PNEUMOVAX23, (strength, dose, frequency, route, lot # and expiration date were not reported) intramuscular for prophylaxis. And on 30-JAN-2019, the patient was vaccinated with a dose of FLUZONE in the same arm. When she administered FLUZONE, there was "a little bit of blood coming out". On 30-JAN-2019, she was experiencing "a lot of pain, redness and swelling in the arm". The patient reported her physician "recommended BENADRYL capsules, BENADRYL spray and cold compresses". On 01-FEB-2019, the patient received a prescription for antibiotic "Flucloxacillin 500 mg twice daily for 5 days". On 02-FEB-2019 (reported as "after only 1 day of antibiotics"), it was reported the patient "stopped taking the antibiotic". The outcome of a lot of pain, redness and swelling in the arm was reported as recovered on 02-FEB-2019. The outcome of a little bit of blood coming out was recovered on unknown date in 2019. The causality was not provided.
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Information has been received from a pharmacist referring a female patient of unknown age. Information about medical history, concurrent conditions and concomitant therapies were not provided. On 09-JUL-2015, the patient was administered first dose GARDASIL 9 (intramuscular, strength, dose, lot # and expiration date were not reported) for prophylaxis. On 23-MAR-2019, the patient was administered second dose GARDASIL 9. On 14-FEB-2019, the patient was administered third dose GARDASIL 9 (lot# N028092 expiration date 28-MAY-2020, dose 0.5 ml). (inappropriate schedule of product administration). No adverse effects reported after any dose.
Sex: F
Vaccine: PPV
Symptoms: Feeling abnormal, Fluid retention, Inflammation
Clinical narrative: This spontaneous report has been received from a female patient in her 50s' years old, via a company representative. Information about medical history, concurrent conditions and concomitant therapies were not provided. On an unknown date, the patient was vaccinated with a unspecified pneumococcal vaccine (manufacturer unknown) (strength, dose detail, route, lot # and expiration date were not reported) for prophylaxis. On an unknown date, the patient had a ton of inflammation and was holding about 3 pounds of water. At the time of this report, the patient felt back on track after some bad days and had more energy and power. The outcome of the event was considered as recovered as she felt good now. The causality assessment was not reported.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant concerning an 18 year old patient of an unknown gender. Medical history, concurrent conditions and concomitant medications were not provided. On 20-FEB-2019, the patient was vaccinated with an improperly strength adult dose of VAQTA (incorrect dose administered, and product administered to patient of inappropriate age) (dose and frequency were not reported) lot # R009799, the expiration date: 02-JUN-2019, intramuscularly for prophylaxis. No adverse effects were reported in the patient.
Age: 1.08
Sex: M
Vaccine: MMR
Symptoms: Rash erythematous, Swelling
Clinical narrative: This spontaneous report was received from a consumer (patient's grandmother) and refers to 13 months old male patient. The patient had no pertinent medical history and concomitant medication. The patient had allergies to fish, egg, sesame, pistachios and cashews. On an unknown date in February 2019, the patient underwent skin allergy test with M-M-R II via intradermal route (dose, lot# and expiration date not reported). The reporter stated that the patient had a significant reaction which included a red, swollen rash (rash erythematous and swelling), developed after the test. The patient did not receive any treatment. On an unknown date in February 2019, the patient recovered from the events of swelling and rash erythematous. The patient sought medical attention and would be receiving vaccination with M-M-R II vaccine on an unspecified date in the near future at the allergist's office. No product quality complaint (PQC) was involved. Causality assessment for the events was not reported.
Sex: F
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: Information has been received from a nurse via a field representative referring to a female patient of unknown age. The patient's medical history included dizziness. The patient's concurrent condition was anxious with her choir group. No information regarding the patient's concomitant medications, drug reactions or allergies was provided. On an unspecified date, the patient received dose of GARDASIL 9 (strength, dose, route, lot# and expiration date were not reported) for prophylaxis. It was unknown if this was the patient's second or third dose of GARDASIL 9. The GARDASIL 9 was the only vaccine the patient received that day. After receiving dose of GARDASIL 9, the patient experienced syncope. The patient was monitored in the office for more than 15 minutes and had recovered by the time she left the office. The causality assessment was not provided. Upon internal review, syncope was determined to be medically significant.
Age: 18.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Arthralgia, Blood culture negative, Blood test abnormal, Cold sweat, Decreased appetite
Clinical narrative: This case was reported by a nurse via other manufacturer and described the occurrence of systemic inflammatory response syndrome in a 18-year-old female patient who received BEXSERO for prophylaxis. Co-suspect products included TRUMENBA for prophylaxis. On 31st July 2017, the patient received the 1st dose of BEXSERO. On 1st June 2017, the patient received the 1st dose of TRUMENBA. On 31st July 2017, 4 hrs 30 min after receiving BEXSERO, the patient experienced systemic inflammatory response syndrome (serious criteria GSK medically significant), fatigue, injection site pain and interchange of vaccine products. In August 2017, the patient experienced appetite absent, sore throat, cold sweat, joint pain and enlargement of lymph nodes. On an unknown date, the outcome of the systemic inflammatory response syndrome, fatigue, appetite absent, sore throat, cold sweat, joint pain, enlargement of lymph nodes, injection site pain and interchange of vaccine products were unknown. It was unknown if the reporter considered the systemic inflammatory response syndrome, fatigue, appetite absent, sore throat, cold sweat, joint pain, enlargement of lymph nodes and injection site pain to be related to BEXSERO. Rerun: Additional details were provided as follows: This case was reported by a Nurse Practitioner. The nurse practitioner did not mention if the patient was on any other medications at the time of the events or if the patient had any other medical conditions to report. The patient received 1st dose of TRUMENBA first on 1st June 2017. The patient for her 2nd dose of TRUMENBA was given BEXSERO instead in error, which led to interchange of vaccine products.  TRUMENBA and BEXSERO should not be given together as per the reporter. The patient was given BEXSERO around 9.30 in the morning and by 2pm that afternoon, the patient was complaining of extreme fatigue and injection site pain. The patient returned to the office and was seen by the nurse practitioner on 4th August 2017. At that time, in addition to the extreme fatigue, was having no appetite, sore throat, swollen lymph nodes, joint pain, and cold sweats. The nurse practitioner ran blood work and blood cultures to rule out mono. Cultures came back normal but the blood work did show patient was having an acute inflammatory response. Reporter stated one of the test results was 21.9 which indicated the acute inflammatory response. The nurse practitioner also mentioned that 4th August 2017 was day 1 of the patient's menstrual period. The nurse practitioner did not say if there was any additional need for follow-up and had informed the reporter that the patient was told to get back in touch or come back in if continued to have issues and they had not seen since 4th August 2017.  The nurse practitioner was unable to provide outcomes for the reported events. As per the nurse practitioner the office would have any product information that might be needed, provided consent for follow-up.
Age: 18.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Fatigue, Injection site pain, Interchange of vaccine products, Lymphadenopathy, Oropharyngeal pain
Clinical narrative: This case was reported by a nurse via other manufacturer and described the occurrence of systemic inflammatory response syndrome in a 18-year-old female patient who received BEXSERO for prophylaxis. Co-suspect products included TRUMENBA for prophylaxis. On 31st July 2017, the patient received the 1st dose of BEXSERO. On 1st June 2017, the patient received the 1st dose of TRUMENBA. On 31st July 2017, 4 hrs 30 min after receiving BEXSERO, the patient experienced systemic inflammatory response syndrome (serious criteria GSK medically significant), fatigue, injection site pain and interchange of vaccine products. In August 2017, the patient experienced appetite absent, sore throat, cold sweat, joint pain and enlargement of lymph nodes. On an unknown date, the outcome of the systemic inflammatory response syndrome, fatigue, appetite absent, sore throat, cold sweat, joint pain, enlargement of lymph nodes, injection site pain and interchange of vaccine products were unknown. It was unknown if the reporter considered the systemic inflammatory response syndrome, fatigue, appetite absent, sore throat, cold sweat, joint pain, enlargement of lymph nodes and injection site pain to be related to BEXSERO. Rerun: Additional details were provided as follows: This case was reported by a Nurse Practitioner. The nurse practitioner did not mention if the patient was on any other medications at the time of the events or if the patient had any other medical conditions to report. The patient received 1st dose of TRUMENBA first on 1st June 2017. The patient for her 2nd dose of TRUMENBA was given BEXSERO instead in error, which led to interchange of vaccine products.  TRUMENBA and BEXSERO should not be given together as per the reporter. The patient was given BEXSERO around 9.30 in the morning and by 2pm that afternoon, the patient was complaining of extreme fatigue and injection site pain. The patient returned to the office and was seen by the nurse practitioner on 4th August 2017. At that time, in addition to the extreme fatigue, was having no appetite, sore throat, swollen lymph nodes, joint pain, and cold sweats. The nurse practitioner ran blood work and blood cultures to rule out mono. Cultures came back normal but the blood work did show patient was having an acute inflammatory response. Reporter stated one of the test results was 21.9 which indicated the acute inflammatory response. The nurse practitioner also mentioned that 4th August 2017 was day 1 of the patient's menstrual period. The nurse practitioner did not say if there was any additional need for follow-up and had informed the reporter that the patient was told to get back in touch or come back in if continued to have issues and they had not seen since 4th August 2017.  The nurse practitioner was unable to provide outcomes for the reported events. As per the nurse practitioner the office would have any product information that might be needed, provided consent for follow-up.
Age: 18.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Systemic inflammatory response syndrome, Wrong product administered
Clinical narrative: This case was reported by a nurse via other manufacturer and described the occurrence of systemic inflammatory response syndrome in a 18-year-old female patient who received BEXSERO for prophylaxis. Co-suspect products included TRUMENBA for prophylaxis. On 31st July 2017, the patient received the 1st dose of BEXSERO. On 1st June 2017, the patient received the 1st dose of TRUMENBA. On 31st July 2017, 4 hrs 30 min after receiving BEXSERO, the patient experienced systemic inflammatory response syndrome (serious criteria GSK medically significant), fatigue, injection site pain and interchange of vaccine products. In August 2017, the patient experienced appetite absent, sore throat, cold sweat, joint pain and enlargement of lymph nodes. On an unknown date, the outcome of the systemic inflammatory response syndrome, fatigue, appetite absent, sore throat, cold sweat, joint pain, enlargement of lymph nodes, injection site pain and interchange of vaccine products were unknown. It was unknown if the reporter considered the systemic inflammatory response syndrome, fatigue, appetite absent, sore throat, cold sweat, joint pain, enlargement of lymph nodes and injection site pain to be related to BEXSERO. Rerun: Additional details were provided as follows: This case was reported by a Nurse Practitioner. The nurse practitioner did not mention if the patient was on any other medications at the time of the events or if the patient had any other medical conditions to report. The patient received 1st dose of TRUMENBA first on 1st June 2017. The patient for her 2nd dose of TRUMENBA was given BEXSERO instead in error, which led to interchange of vaccine products.  TRUMENBA and BEXSERO should not be given together as per the reporter. The patient was given BEXSERO around 9.30 in the morning and by 2pm that afternoon, the patient was complaining of extreme fatigue and injection site pain. The patient returned to the office and was seen by the nurse practitioner on 4th August 2017. At that time, in addition to the extreme fatigue, was having no appetite, sore throat, swollen lymph nodes, joint pain, and cold sweats. The nurse practitioner ran blood work and blood cultures to rule out mono. Cultures came back normal but the blood work did show patient was having an acute inflammatory response. Reporter stated one of the test results was 21.9 which indicated the acute inflammatory response. The nurse practitioner also mentioned that 4th August 2017 was day 1 of the patient's menstrual period. The nurse practitioner did not say if there was any additional need for follow-up and had informed the reporter that the patient was told to get back in touch or come back in if continued to have issues and they had not seen since 4th August 2017.  The nurse practitioner was unable to provide outcomes for the reported events. As per the nurse practitioner the office would have any product information that might be needed, provided consent for follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Skin warm, Swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of skin warm in a 60-year-old female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced skin warm and swelling. On an unknown date, the outcome of the skin warm and swelling were unknown. It was unknown if the reporter considered the skin warm and swelling to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient advised the pharmacist that she experienced swelling and slight warmth to the touch. The pharmacist did not provide lot number and expiry date for dose 1 of SHINGRIX. For tolerance to 2nd dose of SHINGRIX, refer case: US2019032444, reported by the same reporter, for the same patient.
Sex: F
Vaccine: VARZOS
Symptoms: Grip strength decreased, Hypoaesthesia, Peripheral swelling, Protein total increased
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of swelling of fingers in a 84-year-old female patient who received SHINGRIX for prophylaxis. On 10th December 2018, the patient received the 1st dose of SHINGRIX. In December 2018, 5 days after receiving SHINGRIX, the patient experienced swelling of fingers, numbness in fingers and grip strength decreased. On an unknown date, the patient experienced serum total protein increased. The patient was treated with Steroid (Not Specified). SHINGRIX was discontinued. On an unknown date, the outcome of the swelling of fingers, numbness in fingers, grip strength decreased and serum total protein increased were unknown. It was unknown if the reporter considered the swelling of fingers, numbness in fingers, grip strength decreased and serum total protein increased to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported but the patient could be 83 or 84 years old. The patient developed extreme swelling in the fingers of both hands, fingers were so numb and difficult to handle objects. The patient had an emergency room visit and was given steroid and the symptoms resolved then came back. The patient visited a different Doctor of Medicine (MD) and they did know what it was, but drew blood and found elevated blood protein. The patient was not going to get the second shot of SHINGRIX and would like to find out more information. At the time of reporting, the patient's initials and date of birth and SHINGRIX vaccine batch number and expiry date were unknown. Lab Comments: On an unknown date, the patient had elevated blood protein.
Sex: U
Vaccine: MENB
Symptoms: Injection site reaction
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of injection site reaction in an unspecified number of patients who received BEXSERO for prophylaxis. In February 2019, the patients received BEXSERO. In February 2019, less than a month after receiving BEXSERO, the patients experienced injection site reaction. On an unknown date, the outcome of the injection site reaction was unknown. It was unknown if the reporter considered the injection site reaction to be related to BEXSERO. Additional details were provided as follows. The age at vaccination was not applicable for this report. The nurse reported to a GSK (GlaxoSmithKline) employee that approximately 600 students received a BEXSERO injection due to a meningitis outbreak. The injections were given starting on 6th February 2019 and were continuing till the time of report. The nurse reported that some unidentified number of patients had unspecified injection site reactions. The exact quantity of patients experiencing events were not known. The reporter did not consent to follow up.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Fatigue, Headache, Nausea
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of woozy in a 63-year-old female patient who received SHINGRIX (batch number E3Z7E, expiry date 18th May 2021) for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, 2 hrs after receiving SHINGRIX, the patient experienced woozy, nausea, headache, chills and tiredness. On an unknown date, the outcome of the woozy, nausea, headache, chills and tiredness were recovered/resolved. It was unknown if the reporter considered the woozy, nausea, headache, chills and tiredness to be related to SHINGRIX. Additional details were provided as follows: The medical assistant reported that the patient was tired, nauseous, woozy, chills and slept with 4 layers of blankets on. The patient denied for fever. The patient then started with headache in the middle of the night after receiving 1st SHINGRIX vaccine. Symptoms subsided within 24 hours. Outbound calls were attempted, however it was unable to reach the healthcare professional, therefore voice message was left.
Sex: F
Vaccine: FLU4
Symptoms: Hypersensitivity
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of allergic reaction in a female patient who received FLULAVAL QUADRIVALENT 2018-2019 season (batch number 2B55B, expiry date 30th June 2019) for prophylaxis. On an unknown date, the patient received FLULAVAL QUADRIVALENT 2018-2019 season. On an unknown date, less than a year after receiving FLULAVAL QUADRIVALENT 2018-2019 season, the patient experienced allergic reaction. On an unknown date, the outcome of the allergic reaction was unknown. It was unknown if the reporter considered the allergic reaction to be related to FLULAVAL QUADRIVALENT 2018-2019 season. Additional details were provided as follows: The age at vaccination was not reported. The physician stated that the patient had an allergic reaction to FLULAVAL. The physician stated he did not want a follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Erythema, Fatigue, Gastrointestinal disorder, Headache
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 68-year-old female patient who received SHINGRIX for prophylaxis. On 18th February 2019, the patient received the 1st dose of SHINGRIX. On 19th February 2019, 1 days after receiving SHINGRIX, the patient experienced pain in arm, erythema, swelling, myalgia, fatigue, headache, shivering, fever and gastrointestinal symptom nos. On an unknown date, the outcome of the pain in arm, erythema, swelling, myalgia, fatigue, headache, shivering, fever and gastrointestinal symptom nos were unknown. It was unknown if the reporter considered the pain in arm, erythema, swelling, myalgia, fatigue, headache, shivering, fever and gastrointestinal symptom nos to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported, but it could be 67 or 68 years old. The patient went to bed at 8 pm.  Did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Pain in extremity, Pyrexia, Swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 68-year-old female patient who received SHINGRIX for prophylaxis. On 18th February 2019, the patient received the 1st dose of SHINGRIX. On 19th February 2019, 1 days after receiving SHINGRIX, the patient experienced pain in arm, erythema, swelling, myalgia, fatigue, headache, shivering, fever and gastrointestinal symptom nos. On an unknown date, the outcome of the pain in arm, erythema, swelling, myalgia, fatigue, headache, shivering, fever and gastrointestinal symptom nos were unknown. It was unknown if the reporter considered the pain in arm, erythema, swelling, myalgia, fatigue, headache, shivering, fever and gastrointestinal symptom nos to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported, but it could be 67 or 68 years old. The patient went to bed at 8 pm.  Did not consent to follow up.
Age: 1.0
Sex: M
Vaccine: MMRV
Symptoms: Pyrexia, Rash generalised
Clinical narrative: High fever after 1 week exactly. Rash all over body.
Age: 28.0
Sex: F
Vaccine: TYP
Symptoms: Fatigue, Headache, Pruritus, Rash, Rash papular
Clinical narrative: Transcription from 2/12/19; Typhoid vaccine 2 weeks ago. (1/31/19) 1st rash appeared 3-4 days post vaccine. Started with singular , larger patch on L anterior thorax. Headaches and fatigue for 1 week following onset. No nausea/vomiting. Penny-sized with defined border. Intermittent low-grade itching. No changes in skin care. No changes in may have allergy to soy-- gets small rashes on face ate tofu friday , scattered papular rash appeared friday night. No changes in laundry detergent, hygeine products. No itching in throat or tongue. No changes in vision. No numbness/tingling in extremities. No edema, swelling. No dizziness.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Crying, Decreased appetite, Diarrhoea, Gastrointestinal disorder, Selective eating disorder
Clinical narrative: Somnolence, crying nonstop for 3 days, loss of appetite/inability to nurse, diarrhea and continuing gut issues from then on, no weight gain.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Somnolence, Weight gain poor
Clinical narrative: Somnolence, crying nonstop for 3 days, loss of appetite/inability to nurse, diarrhea and continuing gut issues from then on, no weight gain.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: Seen in office 11/5/2018 and reports the following: 1. Fever for x 1 day 11/3/2018 2.  Rash - satrted 11/4/18 and spreading over face and trunk. MD felt symptoms likely secondary to MMR.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: Slightly red area noted at injection site Thursday (2/28/19) night. Area much larger and tender, more painful than itchy on 3/1/19. Came into office 3/2/19. Findings showed 5x10 red tender warm area on upper left arm. Left upper arm circumference 7 7/8", right upper arm circumference 7 1/8". Assessment: local reaction to MMRV vs cellulitis. Treated with cephalexin (250mg/mL, 5mL po bid x 10 days) and hydroxyzine HCl (10mg/mL, 2.5mL po tid x 7days prn) for itching as benedryl was not helping.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Local reaction
Clinical narrative: Slightly red area noted at injection site Thursday (2/28/19) night. Area much larger and tender, more painful than itchy on 3/1/19. Came into office 3/2/19. Findings showed 5x10 red tender warm area on upper left arm. Left upper arm circumference 7 7/8", right upper arm circumference 7 1/8". Assessment: local reaction to MMRV vs cellulitis. Treated with cephalexin (250mg/mL, 5mL po bid x 10 days) and hydroxyzine HCl (10mg/mL, 2.5mL po tid x 7days prn) for itching as benedryl was not helping.
Age: 12.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site swelling
Clinical narrative: Bump to left deltoid at site of injection.
Age: 1.75
Sex: M
Vaccine: RAB
Symptoms: Discomfort, Hyperaesthesia, Pyrexia, Viral infection
Clinical narrative: After the last Rabies vaccine given on 2/18/19 the following day 2/19/19 patient started a fever. He was taken right to the doctors where he was looked over, checked for the flu (negative) and ear infections (negative).  By 9:00pm that evening his fever was 104.7. He also seemed sensitive to touch and uncomfortable. Being in contact with nurse. Patient received tylenol and motrin as advised to break fever and room temperature bath. The highest his fever reached was 105.3. Doctors advised continuing tylenol, motrin and keeping up on fluids and if child was not better by the end of the week to have him seen again, they suggested that this was a virus that just needed to run its course. Fevers stopped by Sunday 2/24/19.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature increased, Chills, Headache, Injection site erythema, Injection site swelling
Clinical narrative: I developed a temp to 101.3, chills, headache and severe mylagias. This lasted approximately 24 hours. I then developed an area of erythema and swelling below the injection site.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: I developed a temp to 101.3, chills, headache and severe mylagias. This lasted approximately 24 hours. I then developed an area of erythema and swelling below the injection site.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Hypersomnia, Influenza like illness, Injection site pain, Injection site swelling, Loss of personal independence in daily activities
Clinical narrative: I'm not sure this qualifies as adverse but each time I received the SHINGRIX vaccine my reaction to it was much stronger than what is described in the literature, and the same each time. About 7 hours after being vaccinated the injection site became very painful and swollen, this lasted about 3 days and was gone after about 5 days, but this was minor. The major issue was my very strong response to the vaccine which left me with flu-like symptoms for approximately 2 days where I slept approximately 90% of that time and was barely able to get out of bed to go to the bathroom or eat anything. I was quite literally incapacitated. The literature mentions this as being expected, sort of, but downplays the severity of just how bad I felt. If this is normal then the literature needs to be much clearer of what to expect. If this is an extreme reaction then I'm curious if this means that I have a strong immune system or if there is something abnormal with me. My reaction to the first vaccination in 9/18 and the second one last week were identical as far as I can tell. I was hoping my reaction the second time would be less severe but it might have been worse, it's hard to know, it certainly wasn't better.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Vaccine positive rechallenge
Clinical narrative: I'm not sure this qualifies as adverse but each time I received the SHINGRIX vaccine my reaction to it was much stronger than what is described in the literature, and the same each time. About 7 hours after being vaccinated the injection site became very painful and swollen, this lasted about 3 days and was gone after about 5 days, but this was minor. The major issue was my very strong response to the vaccine which left me with flu-like symptoms for approximately 2 days where I slept approximately 90% of that time and was barely able to get out of bed to go to the bathroom or eat anything. I was quite literally incapacitated. The literature mentions this as being expected, sort of, but downplays the severity of just how bad I felt. If this is normal then the literature needs to be much clearer of what to expect. If this is an extreme reaction then I'm curious if this means that I have a strong immune system or if there is something abnormal with me. My reaction to the first vaccination in 9/18 and the second one last week were identical as far as I can tell. I was hoping my reaction the second time would be less severe but it might have been worse, it's hard to know, it certainly wasn't better.
Age: 54.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Asthenia, Blood glucose, Blood pressure increased, Cardiac imaging procedure, Dizziness
Clinical narrative: I was feeling well and in good health prior to injection. I received the SHINGRIX (1st treatment dose) at approximately 4pm. I was asked to sit in the waiting room for 20 minutes. Within 5 minutes of injection I began feeling weird and with the following symptoms: foggy vision,  racing heartbeat, dizziness, weakness, overall not feeling right, a significant increase in blood pressure, nausea, spacy feeling. I was taken into the back treatment area where clinical staff and my primary doctor began triage of my condition, especially focused on my blood pressure and heart. My blood pressure continued to rise to approximately 177/123 to my last recollection. I was placed on O2 Sat monitor, EKG measured, and glucose tested. Oxygen was placed. Dr gave orders to call 911 and paramedics arrived taking over the treatment of my adverse reaction to the injection. Paramedics continued triage of my reaction taking a picture of my heart, EKG, and continued BP monitoring. It was indicated I needed to go to the hospital via ambulance. I was placed in the ambulance and taken to Hospital.
Age: 54.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Electrocardiogram, Feeling abnormal, Laboratory test, Nausea, Palpitations
Clinical narrative: I was feeling well and in good health prior to injection. I received the SHINGRIX (1st treatment dose) at approximately 4pm. I was asked to sit in the waiting room for 20 minutes. Within 5 minutes of injection I began feeling weird and with the following symptoms: foggy vision,  racing heartbeat, dizziness, weakness, overall not feeling right, a significant increase in blood pressure, nausea, spacy feeling. I was taken into the back treatment area where clinical staff and my primary doctor began triage of my condition, especially focused on my blood pressure and heart. My blood pressure continued to rise to approximately 177/123 to my last recollection. I was placed on O2 Sat monitor, EKG measured, and glucose tested. Oxygen was placed. Dr gave orders to call 911 and paramedics arrived taking over the treatment of my adverse reaction to the injection. Paramedics continued triage of my reaction taking a picture of my heart, EKG, and continued BP monitoring. It was indicated I needed to go to the hospital via ambulance. I was placed in the ambulance and taken to Hospital.
Age: 54.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Urine analysis, Vision blurred
Clinical narrative: I was feeling well and in good health prior to injection. I received the SHINGRIX (1st treatment dose) at approximately 4pm. I was asked to sit in the waiting room for 20 minutes. Within 5 minutes of injection I began feeling weird and with the following symptoms: foggy vision,  racing heartbeat, dizziness, weakness, overall not feeling right, a significant increase in blood pressure, nausea, spacy feeling. I was taken into the back treatment area where clinical staff and my primary doctor began triage of my condition, especially focused on my blood pressure and heart. My blood pressure continued to rise to approximately 177/123 to my last recollection. I was placed on O2 Sat monitor, EKG measured, and glucose tested. Oxygen was placed. Dr gave orders to call 911 and paramedics arrived taking over the treatment of my adverse reaction to the injection. Paramedics continued triage of my reaction taking a picture of my heart, EKG, and continued BP monitoring. It was indicated I needed to go to the hospital via ambulance. I was placed in the ambulance and taken to Hospital.
Age: 54.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Adverse reaction
Clinical narrative: I was feeling well and in good health prior to injection. I received the SHINGRIX (1st treatment dose) at approximately 4pm. I was asked to sit in the waiting room for 20 minutes. Within 5 minutes of injection I began feeling weird and with the following symptoms: foggy vision,  racing heartbeat, dizziness, weakness, overall not feeling right, a significant increase in blood pressure, nausea, spacy feeling. I was taken into the back treatment area where clinical staff and my primary doctor began triage of my condition, especially focused on my blood pressure and heart. My blood pressure continued to rise to approximately 177/123 to my last recollection. I was placed on O2 Sat monitor, EKG measured, and glucose tested. Oxygen was placed. Dr gave orders to call 911 and paramedics arrived taking over the treatment of my adverse reaction to the injection. Paramedics continued triage of my reaction taking a picture of my heart, EKG, and continued BP monitoring. It was indicated I needed to go to the hospital via ambulance. I was placed in the ambulance and taken to Hospital.
Age: 16.0
Sex: F
Vaccine: HEPA, HPV9, IPV, MENB, TD, VARCEL
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Adult Hepatitis A given to Adolescent.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash pruritic
Clinical narrative: Patient developed an itchy rash on both legs within 24 hours of shot.
Sex: M
Vaccine: HEPA
Symptoms: No adverse event, Product colour issue
Clinical narrative: This spontaneous report was received from a male patient of unknown age reporting on himself. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported. On 22-FEB-2019, the patient was vaccinated with a a crystal clear appearance (product colour issue) VAQTA 50U/l.0ML(strength, route, dose, frequency, anatomical location, lot # and expiration date were unknown) for prophylaxis. No adverse events were reported. At the time of the report, the outcome of product colour issue, was unknown. The reporter di d not mention the causality assesment between the event of product colour issue and VAQTA vaccination.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received on 22-FEB-2019 regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. The patient was prescribed ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 29-JAN-2009, the patient was administered the ZOSTAVAX vaccine (lot# and route not specified) by a pharmacist. On an unspecified date, the patient was treated by a healthcare provider for shingles as a result of vaccination with ZOSTAVAX. The outcome was not provided. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information was received on 22-FEB-2019 from a lawyer regarding a case in litigation regarding a male patient, history not provided. The patient was prescribed ZOSTAVAX by a healthcare provider for the long term prevention of shingles and zoster related conditions. In 2015, at age 69, the patient was administered ZOSTAVAX by a pharmacist at a pharmacy. On an unspecified date, the patient was treated by a physician for the following injuries resulting from ZOSTAVAX: shingles.  Outcome was not provided. Additional information has been requested.