chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: FLUX, PPV
Symptoms: Paraesthesia, Pyrexia
Clinical narrative: Case number PHHY2016US160840, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 651384) website on 21 Nov 2016. This report refers to a 39 years old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with seasonal influenza vaccine INN (manufacturer and batch number: not reported) into left arm on 06 Sep 2016. The patient also vaccinated with pneumococcal vaccine (other manufacture, batch number: not reported) (reported as pneumo vaccine) on 06 Sep 2016. It was reported that, patient while at work on 03 occasions between 04:00 pm and 09:00 pm (on 06 Sep 2016), got really warm and felt like she was going to pass out. That same night patient went to bed and woke up in a complete sweat had a headache and low grade fever. The next morning patient woke up and her muscles and joints hurt, nausea, low grade fever, dizzy and felt disoriented and not to mention, the left arm was so painful and her armpit was extremely sore. Patient called the clinic and spoke with her physician nurse and she excused her from work because patient was incapable of going and she rested all day Wed. The patient took a lot of Ibuprofen which did not help the fever or pain for very long. The patient had absolutely no appetite and did her best at keeping hydrated. On Wed night patient woke up a few times drenched in sweat that she had to wash her pillow and bedding. The patient could not afford to miss another day, so Thurs she went to work. It was completely rough as she work in healthcare. The patient was in a sweat her entire 08 hours and was dizzy, weak and nauseous as well as leg achiness and feeling of being shocked. The patient forgot to mention she did call facility back and talked to her physician nurse and she said patient had an allergic reaction to the pneumonia vaccine. The outcome of the events was reported as complete recovery on an unknown date. The seriousness of the events was reported as non serious. The causality of the events was not reported.
Age: 66.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Myalgia, Pyrexia, Rash, Urticaria
Clinical narrative: Case number PHHY2016US161202, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 651386) website on 21 Nov 2016. This report refers to a 66-years-old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with seasonal influenza INN (manufacturer unknown and batch number: not reported) intramuscularly in right arm on 07 Sep 2016. On the same day after vaccination, she experienced fever, uncontrollable shivering/teeth chattering, muscle aches and rash/hives all over torso. The outcome of the events was reported as condition unchanged. The seriousness and causality of the events was not reported.
Age: 36.0
Sex: M
Vaccine: FLUX
Symptoms: Fatigue, Injection site bruising, Injection site pain, Injection site swelling, Throat irritation
Clinical narrative: Case number PHHY2016US160873 is an initial spontaneous report received from a consumer via the Vaccine Adverse Event Reporting System (VAERS reference number: 651387) website on 21 Nov 2016. This report refers to 36 year old male patient. Medical history and concomitant medication was not reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer unknown) into left arm on 08 Sep 2016. On the same day, the patient experienced tired, scratchy throat, swollen quarter sized bump on site of injection area, tenderness, pain and soreness at the injection spot, arm bruised at injection spot. The outcome of the events was condition unchanged. The seriousness of the event was non serious. The causality of the events was not reported.
Age: 4.0
Sex: M
Vaccine: FLUX
Symptoms: Excessive eye blinking, Tic
Clinical narrative: Case number PHHY2016US161274, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 651575) website on 21 Nov 2016. This report refers to a 04-years-old male patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with seasonal influenza virus vaccine INN (unknown manufacturer, batch number: not reported) intramuscularly in arm on 17 Oct 2013. On 27 Oct 2013, the patient developed tic and experienced repetitive quick eye blinking. The outcome of the events tic and repetitive quick eye blinking was reported as complete recovery on an unknown date. The seriousness and causality of the events tic and repetitive quick eye blinking was not reported.
Age: 64.0
Sex: M
Vaccine: FLUX
Symptoms: Dysphonia, Malaise, Speech disorder
Clinical narrative: Case number PHHY2016US161211, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 651978) website on 21 Nov 2016. This report refers to a 64-years-old male patient. Past medical history was not reported. Current conditions included penicillin allergy. Concomitant medications included finasteride and dutasteride. The patient was vaccinated with seasonal influenza vaccine inn (manufacturer unknown and batch number: not reported) on 31 Aug 2016. On the same day after vaccination, the patient experienced hoarse throat/ could not talk very well and overall feeling of extreme illness that lasted for 3 full days before he was well again. It was reported that, the patient was in good health. The outcome of the events was reported as complete recovery. The seriousness and causality of the events was not reported.
Age: 26.0
Sex: F
Vaccine: FLUX
Symptoms: Fibromyalgia
Clinical narrative: Case number PHHY2016US161309, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 653797) website on 21 Nov 2016. This report refers to a 26-years-old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with seasonal influenza virus vaccine INN (unknown manufacturer, batch number: not reported) on 01 Oct 2014. On 15 Oct 2014, the patient experienced fibromyalgia symptoms. The outcome of the event fibromyalgia was reported as condition unchanged. The seriousness and causality of the event fibromyalgia was not reported.
Age: 40.0
Sex: F
Vaccine: FLUX
Symptoms: Pruritus, Urticaria
Clinical narrative: Case number PHHY2016US161344, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 654411) website on 21 Nov 2016. This report refers to 40-years-old female patient. Past medical history was not reported. Current condition included egg allergy and allergy to inactivated flu vaccine. Concomitant medications not reported. The patient was vaccinated with seasonal influenza virus vaccine INN (unknown manufacturer, batch number: not reported) on an unspecified date. On an unspecified date, the patient experienced hives and itching. The outcome, seriousness and causality of the events itching and hives were not reported.
Sex: F
Vaccine: FLUX
Symptoms: Skin warm, Swelling, Urticaria
Clinical narrative: Case number PHHY2016US161366, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 654639) website on 21 Nov 2016. This report refers to a 44-year-old female patient. Past medical history was not reported. Current condition included allergies. Concomitant medications were not reported. The patient was vaccinated with seasonal influenza virus vaccine INN (unknown manufacturer, batch number: not reported) in right arm on 21 Sep 2016. On the same day after vaccination, the patient experienced swelling welt which was very hot. The welt continued to swell overnight and in the next morning it was approximately 06 inches in diameter and was still spreading and extremely hot. The outcome of the events swelling, welt and skin warm was reported as condition unchanged. The seriousness of the events was reported as non serious. The causality of the events was not reported.
Age: 28.0
Sex: F
Vaccine: FLUX
Symptoms: Injected limb mobility decreased, Injection site pain, X-ray
Clinical narrative: Case number PHHY2016US161920, is an initial spontaneous report received from a healthcare professional via the Vaccine Adverse Event Reporting System (VAERS reference number: 655085) website on 21 Nov 2016. This report refers to a 28-years-old female patient. Past medical history was not reported. Current conditions included asthma. Concomitant medications included albuterol and DEPO PROVERA. The patient was vaccinated with seasonal influenza vaccine INN (manufacturer unknown and batch number: not reported) in left arm on 29 Aug 2016. On the same day after vaccination, the patient experienced limited range of motion in left shoulder and shoulder pain the same day as the shot. Pain and range of motion got worse as time went on. The patient visited nurse practitioner two weeks following flu vaccine. The patient was treated with Ice (three times a day) and ALEVE (2 in morning and 2 at night). The patient then visited Orthopedic doctor and an X ray was taken (results unspecified). The patient was treated with Cortisone shot. She stated that, there was some relief in pain two days after the shot and four days after the shot pain was slowly coming back. The patient visited the emergency room. The outcome of the events was reported as condition unchanged. The seriousness and causality of the events was not reported.
Age: 56.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Diarrhoea, Dizziness, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Case number PHHY2016US162276, is an initial spontaneous report received Vaccine Adverse Event Reporting System (VAERS reference number: 656195) website on 21 Nov 2016. This report refers to a 56 years old female patient. Past medical history included as patient had knee replacement surgery on 04 Aug 2016. Current condition included as allergic to cats. Concomitant medications included as tramadol, EXFORGE. The patient was vaccinated with seasonal influenza vaccine INN (manufacturer and batch number: not reported) on 20 Sep 2016. The patient also vaccinated with pneumococcal vaccine (other manufacturer, batch number: not reported) on 20 Sep 2016. On 27 Sep 2016, the patient experienced dizziness, faint, vomiting, diarrhea, injection site itchy, red, hot and swollen. The patient visited the emergency room. The outcome of the events was reported as complete recovery on an unknown date. The seriousness of the events was reported as non serious. The causality of the events was not reported.
Age: 56.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site warmth, Syncope, Vomiting
Clinical narrative: Case number PHHY2016US162276, is an initial spontaneous report received Vaccine Adverse Event Reporting System (VAERS reference number: 656195) website on 21 Nov 2016. This report refers to a 56 years old female patient. Past medical history included as patient had knee replacement surgery on 04 Aug 2016. Current condition included as allergic to cats. Concomitant medications included as tramadol, EXFORGE. The patient was vaccinated with seasonal influenza vaccine INN (manufacturer and batch number: not reported) on 20 Sep 2016. The patient also vaccinated with pneumococcal vaccine (other manufacturer, batch number: not reported) on 20 Sep 2016. On 27 Sep 2016, the patient experienced dizziness, faint, vomiting, diarrhea, injection site itchy, red, hot and swollen. The patient visited the emergency room. The outcome of the events was reported as complete recovery on an unknown date. The seriousness of the events was reported as non serious. The causality of the events was not reported.
Age: 22.0
Sex: F
Vaccine: FLUX
Symptoms: Headache, Injection site swelling, Nausea
Clinical narrative: Case number PHHY2016US161566, is an initial spontaneous report received via Vaccine Adverse Event Reporting System (VAERS reference number: 656225) on 21 Nov 2016. This report refers to a 22-year-old female patient. Medical history included cold earlier in the week and flu-like symptoms two weeks before the flu shot. Current condition included Hashimoto's thyroid. Concomitant medication included Generic CLARITIN and levothyroxine. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) into left arm on 29 Sep 2016. On the same day, the patient experienced severe headache, nausea and swelling at injection site. She took two doses of BENADRYL as she thought this could be an allergic reaction. The outcome of the events was reported as condition unchanged. The seriousness and causality of the events was not reported.
Age: 49.0
Sex: M
Vaccine: FLUX
Symptoms: Abasia, Balance disorder, Blood test, Chest pain, Dizziness
Clinical narrative: Case number PHHY2016US162738 is an initial spontaneous report received from other health care professional via Vaccine Adverse Event Reporting System (VAERS reference number: 656574) website on 21 Nov 2016. This report refers to 49 year old male patient. Current condition included diabetes and high blood pressure. Concomitant medication included LANTUS pen and Lisinopril. The patient was vaccinated with seasonal influenza vaccine (manufacturer unknown) on 30 Sep 2016. On the same day, the patient experienced dizziness, trouble breathing, balance could not walk, chest pains, very bad headache, vomiting and rapid heartbeat, felt his throat was closing and felt flushing on face. The patient had undergone for x ray (X-radiation) and blood test (unspecified, results, normal range were not reported). The patient had visited emergency room on an unknown date. The outcome of the events was reported as condition unchanged. The seriousness of the events was not reported. The causality of the events was not reported.
Age: 49.0
Sex: M
Vaccine: FLUX
Symptoms: Dyspnoea, Flushing, Headache, Heart rate increased, Throat tightness
Clinical narrative: Case number PHHY2016US162738 is an initial spontaneous report received from other health care professional via Vaccine Adverse Event Reporting System (VAERS reference number: 656574) website on 21 Nov 2016. This report refers to 49 year old male patient. Current condition included diabetes and high blood pressure. Concomitant medication included LANTUS pen and Lisinopril. The patient was vaccinated with seasonal influenza vaccine (manufacturer unknown) on 30 Sep 2016. On the same day, the patient experienced dizziness, trouble breathing, balance could not walk, chest pains, very bad headache, vomiting and rapid heartbeat, felt his throat was closing and felt flushing on face. The patient had undergone for x ray (X-radiation) and blood test (unspecified, results, normal range were not reported). The patient had visited emergency room on an unknown date. The outcome of the events was reported as condition unchanged. The seriousness of the events was not reported. The causality of the events was not reported.
Age: 49.0
Sex: M
Vaccine: FLUX
Symptoms: Vomiting, X-ray
Clinical narrative: Case number PHHY2016US162738 is an initial spontaneous report received from other health care professional via Vaccine Adverse Event Reporting System (VAERS reference number: 656574) website on 21 Nov 2016. This report refers to 49 year old male patient. Current condition included diabetes and high blood pressure. Concomitant medication included LANTUS pen and Lisinopril. The patient was vaccinated with seasonal influenza vaccine (manufacturer unknown) on 30 Sep 2016. On the same day, the patient experienced dizziness, trouble breathing, balance could not walk, chest pains, very bad headache, vomiting and rapid heartbeat, felt his throat was closing and felt flushing on face. The patient had undergone for x ray (X-radiation) and blood test (unspecified, results, normal range were not reported). The patient had visited emergency room on an unknown date. The outcome of the events was reported as condition unchanged. The seriousness of the events was not reported. The causality of the events was not reported.
Age: 20.0
Sex: F
Vaccine: FLUX, TDAP
Symptoms: Injection site swelling, Injection site warmth, Pain in extremity, Pyrexia
Clinical narrative: Case number PHHY2016US162126, is an initial spontaneous report received Vaccine Adverse Event Reporting System (VAERS reference number: 656622) website on 21 Nov 2016. This report refers to a 20 years old female patient. Past medical history included as cervicalgia and chronic pain. Current condition included: reflex sympathetic dystrophy. Concomitant medications was not reported. The patient was vaccinated with seasonal influenza vaccine INN (manufacturer and batch number: not reported) into left arm on 19 Sep 2016. The patient also vaccinated with Tdap vaccine (other manufacturer, batch number: not reported) on 19 Sep 2016 and also vaccinated with pneumococcal vaccine (other manufacture, batch number: not reported) into left arm on an unspecified date. On 19 Sep 2016 at evening after vaccination, the patient experienced left arm pain - flu/pneumococcal site, left leg pain, fever with body temperature 103 to 104 (unit unspecified)-daily for first 04 days after vaccine, swollen upper left arm and hot to touch area. The outcome of the events was reported as complete recovery on an unknown date. The seriousness of the events was reported as non serious. The causality of the events was not reported.
Age: 2.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Agitation, Polydipsia, Thirst, Type 1 diabetes mellitus
Clinical narrative: Parents request this form to be submitted. Patient received his flu vaccine 12/22/16 and developed diabetes Type 1 on 1/17/17. His sister 9 mo of age developed diabetes Type 1 - 2 weeks before him. He received flu vaccine 10/5/15 and 11/10/15 as well.
Age: 2.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Blood glucose increased, Type 1 diabetes mellitus
Clinical narrative: Parents request this form to be submitted. Patient received his flu vaccine 12/22/16 and developed diabetes Type 1 on 1/17/17. His sister 9 mo of age developed diabetes Type 1 - 2 weeks before him. He received flu vaccine 10/5/15 and 11/10/15 as well.
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Induration, Skin warm
Clinical narrative: This spontaneous report was received from a pharmacist referring to a 67 year old female patient. The patient's pertinent medical history was not reported. Drug reactions/allergies were reported as none. Concurrent conditions included hypertension. Concomitant therapies included prednisone (manufacturer unknown) and an unspecified "blood pressure medicine". On 31-JAN-2017, the patient was vaccinated with a dose of ZOSTAVAX subcutaneously, lot # M035148 with expiration date 25-OCT-2017, for prophylaxis. On 01-FEB-2017, the patient experienced injection site redness. On 02-FEB-2017 the patient reported to the pharmacist that the reddened area felt hardened and warm. It was stated that no treatment was given for the adverse events. At the time of reporting, the outcome of injection site erythema, injection site induration and injection site warmth was reported as not recovered. A product quality complaint was not involved. The causality assessment between the events and ZOSTAVAX was not provided. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: This spontaneous report was received from a pharmacist referring to a 67 year old female patient. The patient's pertinent medical history was not reported. Drug reactions/allergies were reported as none. Concurrent conditions included hypertension. Concomitant therapies included prednisone (manufacturer unknown) and an unspecified "blood pressure medicine". On 31-JAN-2017, the patient was vaccinated with a dose of ZOSTAVAX subcutaneously, lot # M035148 with expiration date 25-OCT-2017, for prophylaxis. On 01-FEB-2017, the patient experienced injection site redness. On 02-FEB-2017 the patient reported to the pharmacist that the reddened area felt hardened and warm. It was stated that no treatment was given for the adverse events. At the time of reporting, the outcome of injection site erythema, injection site induration and injection site warmth was reported as not recovered. A product quality complaint was not involved. The causality assessment between the events and ZOSTAVAX was not provided. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: HEPATYP, MMRV
Symptoms: Lethargy, Pyrexia
Clinical narrative: Hi fever and lethargic.
Age: 0.33
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 4 month old patient. The patient's concurrent conditions, medical history and drug allergies were not reported. On 02-DEC-2016, the patient was vaccinated with improperly stored ROTATEQ, oral, (dose not reported) from lot # M031802 with expiry date: 09-NOV-2017 for prophylaxis. Concomitant medications were not reported. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information is not expected as all the correspondence have been received. Narrative updated. Sender's Comments: US-009507513-1610USA008140: US-009507513-1610USA014705.
Age: 0.33
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 4 month old patient. The patient's concurrent conditions, medical history and drug allergies were not reported. On 29-NOV-2016, the patient was vaccinated with improperly stored ROTATEQ, oral, (dose not reported) from lot # M007311 with expiry date: unspecified for prophylaxis. Concomitant medications were not reported. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Follow-up information indicated that suspect product with the lot# M007311 had not actually involved in the previously reported temperature excursion. Therefore, case # 1612USA012684 is being deleted from our files on generic rotavirus vaccine, live, oral, pentavalent. Sender's Comments: US-009507513-1610USA008140: US-009507513-1610USA014705.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received on 10-JAN-2017 from a nurse regarding an unspecified number of patients of unknown ages and gender. The patients' concurrent conditions, medical history and concomitant therapy were not reported. On unknown dates, an unspecified number of unspecified patients were vaccinated with doses of VARIVAX (Lot number M033214 expiration 13-JUL-2018, lot number M034584 expiration 27-JUL2018, lot number M028552 expiration 07-JUN-2018, and lot number M009766 expiration 23-FEB-2018) for prophylaxis which were improperly stored. The vaccine doses were exposed to -12.7 C for 2 hours 3 minutes, -13.1 C for 1 hour 43 minutes and -12 C for 2 hours 17 minutes. No adverse effected were reported. No additional information was provided. Additional information has been requested.
Age: 83.0
Sex: M
Vaccine: PPV
Symptoms: Abdominal pain upper, Chills, Fatigue, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 83-year-old male patient. The patient's pertinent medical history included atrial fibrillation. Concomitant medications included SINGULAIR, BETAPACE, VITAMIN K and COUMADIN. The patient did not have any drug reactions or allergies. On 17-JAN-2017, the patient was vaccinated with PNEUMOVAX 23 injection intramuscularly, lot # L033707, expiration date: 18-MAY-2017 (dose was not provided) for prevention of pneumococcal disease. On 17-JAN-2017, the patient experienced swelling/soreness at the injection site that extended to the elbow, stomach ache, fatigue, fever, chills and vision changes. The reporter stated that the patient's vision was affected by the patient looking at the color white and the white object would look amber in color. The patient did not receive any treatment for the events, however, he sought medical attention by contacting an unspecified physician by phone. The outcome of the events and the causality assessment were not provided. Additional information has been requested.
Age: 83.0
Sex: M
Vaccine: PPV
Symptoms: Pyrexia, Visual impairment
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 83-year-old male patient. The patient's pertinent medical history included atrial fibrillation. Concomitant medications included SINGULAIR, BETAPACE, VITAMIN K and COUMADIN. The patient did not have any drug reactions or allergies. On 17-JAN-2017, the patient was vaccinated with PNEUMOVAX 23 injection intramuscularly, lot # L033707, expiration date: 18-MAY-2017 (dose was not provided) for prevention of pneumococcal disease. On 17-JAN-2017, the patient experienced swelling/soreness at the injection site that extended to the elbow, stomach ache, fatigue, fever, chills and vision changes. The reporter stated that the patient's vision was affected by the patient looking at the color white and the white object would look amber in color. The patient did not receive any treatment for the events, however, he sought medical attention by contacting an unspecified physician by phone. The outcome of the events and the causality assessment were not provided. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age and gender. Information about concomitant therapy, concurrent condition, drug reactions/allergies and medical history was not provided. On 20-JAN-2017 the patient was vaccinated with an expired dose of ZOSTAVAX (lot # L04044 with expiration date 15-JAN-2017, subcutaneous, strength and dose unknown) for prophylaxis. No side effect was reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: Information about concomitant therapy, concurrent condition, drug reactions/allergies and medical history was not provided. On an unspecified date, the patient was vaccinated with the first dose of GARDASIL (strength, dose, route, lot # and expiration date were unknown) for prophylaxis and a second dose (lot # and expiration date unknown) on another unspecified date. On another unspecified date, the patient was vaccinated with a dose of GARDASIL 9 (strength, dose, route, lot # and expiration date were unknown) for prophylaxis (interchange of vaccine products). No adverse effect was reported.   Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse prescriber and refers to unspecified patients of unknown ages and genders. There was no information about patients' concomitant medications and pertinent medical history reported. On an unknown date, the patients were vaccinated with doses of improperly stored VARIVAX, lot number  M035140 and expiration date 03-AUG-2018 (route of administration and anatomical location were not reported) for prophylaxis. The vaccines were stored at a lowest recorded temperature of  5F (-15 Celsius) and highest 14F (-10 Celsius) for 30 minutes due to a data logger issue. No previous temperature excursion was reported.  No adverse effects were reported. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On 27-JAN-2017, the patient was inadvertently vaccinated with an expired dose of VARIVAX lot # L000454, expiration date: 06-JAN-2017, as prophylaxis (Strength, dose and route of administration were not reported). No adverse effects were reported. A product quality complaint (PQC) was not involved. Additional information has been requested.
Sex: U
Vaccine: HPV4
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. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, since 03-NOV-2016, the patients were vaccinated with the improperly stored (above 8 degrees Celsius but below 25 degrees Celsius (9.7 degrees Celsius) for 32 hours and 30 minutes) doses of GARDASIL (dose, route of administration, lot # and expiration date were not reported) for prophylaxis. No adverse experiences and no previous excursion were reported. The call was made because of the data logger. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1702USA004089: US-009507513-1702USA004091: US-009507513-1702USA004088: US-009507513-1702USA004090.
Sex: F
Vaccine: PPV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's concomitant medications, pertinent medical history and drug reactions or allergies were not reported. On an unknown date, the patient was vaccinated with their first dose of PNEUMOVAX 23 injection (exact dose, route of administration, lot # and expiry date were not reported). Then, on unknown dates and at unspecified intervals between doses, the patient received their second and third dose of PNEUMOVAX 23 injection (exact dose, route of administration, lot # and expiry date were not reported). The reporting pharmacist did not administer any doses to the patient. No adverse effects were reported. Product quality complaint was not involved. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On 11-JAN-2017, the patient was vaccinated with an improperly stored dose of PEDVAXHIB lot # L042835, expiration date:19-AUG-2018, as prophylaxis (Strength and dose were not reported), which experienced a temperature excursion between 46 and 77 Fahrenheit degrees for 2 hours and 30 minutes. There were no previous temperature excursions reported. Digital data logger was involved. No adverse effects were reported. A product quality complaint was not involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1702USA003692: US-009507513-1702USA003693: US-009507513-1702USA003694: US-009507513-1702USA003695: US-009507513-1702USA003696: US-009507513-1702USA003697.
Age: 0.6
Sex: M
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medial assistant and refers an unknown number of patients of unknown demographics. The patients' pertinent medical history, drug reactions or allergies and concomitant medications were not reported. The reporter stated that an unknown dates since 12-JAN-2017, the patients received an improperly stored doses of PEDVAXHIB (involved lot numbers: M007762 with expiration date at 07-DEC-2018, M025193 with expiration date at 21-MAR-2019 and L033690 with expiration date at 14-JUN-2018; dose and route of administration were not reported) for prophylaxis. The administered doses of vaccine were exposed to a temperature of 46 and 77 (unit not provided) for 39 minutes. No previous temperature excursion was reported. Data logger was used to track the temperature. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1702USA004067: US-009507513-1702USA004072: US-009507513-1702USA004069: US-009507513-1702USA004070: US-009507513-1702USA004071: US-009507513-1702USA004066: US-009507513-1702USA004068.
Sex: M
Vaccine: HPV9
Symptoms: Cardiac arrest, Foetal exposure during pregnancy, Hepatic failure, Renal failure, Supraventricular tachycardia
Clinical narrative: This spontaneous report was received from pediatrician referring a currently 6 weeks old male patient. The patient's medical history included family history of supraventricular tachycardia (SVT) in a  grandparent. On 29-SEP-2016, the patient's mother was vaccinated with the first dose of GARDASIL 9 (Lot # M016193, expiration date was not reported). The patient's mother was also using prenatal vitamins (reported in MARRS case #1702USA001555). On an unspecified date in 2016, the patient experienced fetal tachycardia. On 21-JAN-2017 (at one month of age), the patient developed SVT with cardiac arrest, renal and hepatic failure. At the time of the report, the outcome of tachycardia foetal, SVT with cardiac arrest, hepatic failure and renal failure was reported as recovered/resolved. But the patient remained on therapy with Sotalol. Upon internal review the adverse events cardiac arrest, tachycardia foetal, hepatic failure, renal failure and supraventricular tachycardia were considered medically significant. The reporter did not assess the causal relationship between the adverse events and the vaccination of the patient's mother with GARDASIL 9. This is one of two cases received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1702USA001555.
Sex: M
Vaccine: HPV9
Symptoms: Tachycardia foetal
Clinical narrative: This spontaneous report was received from pediatrician referring a currently 6 weeks old male patient. The patient's medical history included family history of supraventricular tachycardia (SVT) in a  grandparent. On 29-SEP-2016, the patient's mother was vaccinated with the first dose of GARDASIL 9 (Lot # M016193, expiration date was not reported). The patient's mother was also using prenatal vitamins (reported in MARRS case #1702USA001555). On an unspecified date in 2016, the patient experienced fetal tachycardia. On 21-JAN-2017 (at one month of age), the patient developed SVT with cardiac arrest, renal and hepatic failure. At the time of the report, the outcome of tachycardia foetal, SVT with cardiac arrest, hepatic failure and renal failure was reported as recovered/resolved. But the patient remained on therapy with Sotalol. Upon internal review the adverse events cardiac arrest, tachycardia foetal, hepatic failure, renal failure and supraventricular tachycardia were considered medically significant. The reporter did not assess the causal relationship between the adverse events and the vaccination of the patient's mother with GARDASIL 9. This is one of two cases received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1702USA001555.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On 01-NOV-2016, the patient was vaccinated with an improperly stored dose of PEDVAXHIB lot # L042835, expiration date:19-AUG-2018, as prophylaxis (Strength and dose were not reported), which experienced a temperature excursion between 46 and 77 Fahrenheit degrees for 2 hours and 30 minutes. There was no previous temperature excursions reported. Digital data logger was involved. No adverse effects were reported. A product quality complaint was not involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1702USA000452: US-009507513-1702USA003693: US-009507513-1702USA003694: US-009507513-1702USA003695: US-009507513-1702USA003696: US-009507513-1702USA003697.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On 17-OCT-2016, the patient was vaccinated with an improperly stored dose of PEDVAXHIB lot # L042835, expiration date:19-AUG-2018, as prophylaxis (Strength and dose were not reported), which experienced a temperature excursion between 46 and 77 Fahrenheit degrees for 2 hours and 30 minutes. There were no previous temperature excursions reported. Digital data logger was involved. No adverse effects were reported. A product quality complaint was not involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1702USA000452: US-009507513-1702USA003692: US-009507513-1702USA003694: US-009507513-1702USA003695: US-009507513-1702USA003696: US-009507513-1702USA003697.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On 07-DEC-2016, the patient was vaccinated with an improperly stored dose of PEDVAXHIB lot # L042835, expiration date:19-AUG-2018, as prophylaxis (Strength and dose were not reported), which experienced a temperature excursion between 46 and 77 Fahrenheit degrees for 2 hours and 30 minutes. There were no previous temperature excursions reported. Digital data logger was involved. No adverse effects were reported. A product quality complaint was not involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1702USA000452: US-009507513-1702USA003692: US-009507513-1702USA003693: US-009507513-1702USA003695: US-009507513-1702USA003696: US-009507513-1702USA003697.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On 20-OCT-2016, the patient was vaccinated with an improperly stored dose of PEDVAXHIB lot # L042835, expiration date:19-AUG-2018, as prophylaxis (Strength and dose were not reported), which experienced a temperature excursion between 46 and 77 Fahrenheit degrees for 2 hours and 30 minutes. There were no previous temperature excursions reported. Digital data logger was involved. No adverse effects were reported. A product quality complaint was not involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1702USA000452: US-009507513-1702USA003692: US-009507513-1702USA003693: US-009507513-1702USA003694: US-009507513-1702USA003696: US-009507513-1702USA003697.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On 27-SEP-2016, the patient was vaccinated with an improperly stored dose of VARIVAX lot # L035127, expiration date:14-SEP-2017, as prophylaxis (Strength and dose were not reported), which experienced a temperature excursion between 14 and 46 Fahrenheit degrees for 3 hours. There were no previous temperature excursions reported. Digital data logger was involved. No adverse effects were reported. A product quality complaint was not involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1702USA000452: US-009507513-1702USA003692: US-009507513-1702USA003693: US-009507513-1702USA003694: US-009507513-1702USA003695: US-009507513-1702USA003696.
Sex: F
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers an unknown number of patients of unknown demographics. The patients' pertinent medical history, drug reactions or allergies and concomitant medications were not reported. The reporter stated that an unknown dates since 12-JAN-2017, the patients received an improperly stored doses of ROTATEQ orally (lot # L046318 with expiration date at 28-SEP-2017 and lot # reported as M014755 with expiration date at 30-OCT-2017; dose was not reported) for prophylaxis. The administered doses of vaccine were exposed to a temperature of 46 and 77 (unit not provided) for 39 minutes. No previous temperature excursion was reported. Data logger was used to track the temperature. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1702USA000822: US-009507513-1702USA004072: US-009507513-1702USA004069: US-009507513-1702USA004070: US-009507513-1702USA004071: US-009507513-1702USA004066: US-009507513-1702USA004068.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medial assistant and refers an unknown number of patients of unknown demographics. The patients' pertinent medical history, drug reactions or allergies and concomitant medications were not reported. The reporter stated that an unknown dates since 12-JAN-2017, the patients received an improperly stored doses of GARDASIL 9 (involved lot numbers: M026306 with expiration date at 30-APR-2018 and M034780 with expiration date at 15-APR-2019; dose and route of administration were not reported) for prophylaxis. The administered doses of vaccine were exposed to a temperature of 46 and 77 (unit nor provided) for 39 minutes. No previous temperature excursion was reported. Data logger was used to track the temperature. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1702USA004067: US-009507513-1702USA000822: US-009507513-1702USA004069: US-009507513-1702USA004070: US-009507513-1702USA004071: US-009507513-1702USA004066: US-009507513-1702USA004068.
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. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, since 03-NOV-2016, the patients were vaccinated with the improperly stored (above 8 degrees Celsius but below 25 degrees Celsius (9.7 degrees Celsius) for 32 hours and 30 minutes) doses of PEDVAXHIB (dose, route of administration, lot # and expiration date were not reported) for prophylaxis. No adverse experiences and no previous excursion were reported. The call was made because of the data logger. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1702USA004091: US-009507513-1702USA004090: US-009507513-1701USA014195: US-009507513-1702USA004089.
Sex: U
Vaccine: PPV
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. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, since 03-NOV-2016, the patients were vaccinated with the improperly stored (above 8 degrees Celsius but below 25 degrees Celsius (9.7 degrees Celsius) for 32 hours and 30 minutes) doses of PNEUMOVAX 23 (dose, route of administration, lot # and expiration date were not reported) for prophylaxis. No adverse experiences and no previous excursion were reported. The call was made because of the data logger. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA014195: US-009507513-1702USA004088: US-009507513-1702USA004091: US-009507513-1702USA004090.
Sex: U
Vaccine: RV5
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. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, since 03-NOV-2016, the patients were vaccinated with the improperly stored (above 8 degrees Celsius but below 25 degrees Celsius (9.7 degrees Celsius) for 32 hours and 30 minutes) doses of ROTATEQ (orally; dose, lot # and expiration date were not reported) for prophylaxis. No adverse experiences and no previous excursion were reported. The call was made because of the data logger. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1702USA004089: US-009507513-1702USA004088: US-009507513-1701USA014195: US-009507513-1702USA004091.
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. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, since 03-NOV-2016, the patients were vaccinated with the improperly stored (above 8 degrees Celsius but below 25 degrees Celsius (9.7 degrees Celsius) for 32 hours and 30 minutes) doses of VAQTA (dose, route of administration, lot # and expiration date were not reported) for prophylaxis. No adverse experiences and no previous excursion were reported. The call was made because of the data logger. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA014195: US-009507513-1702USA004090: US-009507513-1702USA004088: US-009507513-1702USA004089.
Age: 1.75
Sex: M
Vaccine: DTAP, HEPA, HIBV, PNC13
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Injection site became warm, red and swollen. Mother notified providers office and patient was seen by a provider.