chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Deafness neurosensory
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 657068) on 02-MAY-2017. This spontaneous report refers to a 11 year old male patient. The patient's medical history and concurrent illnesses were reported as none. The patient's other medications and prior vaccinations were not reported. On 23-AUG-2016, the patient was vaccinated with the first dose of GARDASIL 9 intramuscularly in the right arm, lot # L043214 (expiration date was not reported) for prophylaxis. On the same day, the patient was also vaccinated with ADACEL (dose number: 1, intramuscularly in the left arm, lot # U5477AA, manufacturer: Sanofi Pasteur; lot expiration date was not reported) and MENACTRA (dose number: 1, intramuscularly in the left arm, lot # U5410AA, manufacturer: Sanofi Pasteur; lot expiration date was not reported) for prophylaxis. On 25-AUG-2016, the patient developed sudden onset of right sided sensorineural hearing loss after 11 years vaccine. Evaluation by otolaryngologist (ENT) revealed sudden onset sensorineural hearing loss. The patient was not likely to resume normal hearing. The patient required emergency room (ER) visit. The outcome for the event was unknown. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: FLU4, HPV9, MNQ, TDAP
Symptoms: Extra dose administered
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 659592) on 02-MAY-2016. This spontaneous report as received from a regulatory authority refers to a 11 year old female patient. The patient had no concurrent illnesses and medical history. Information on the patient's prior vaccinations and other medications were not reported. On 13-JUN-2016 patient was vaccinated with ADACEL prior to moving. On 29-SEP-2016 the patient was vaccinated with first dose of GARDASIL 9 intramuscularly in the left arm, lot # M026306 (dose, frequency and lot expiration date were not reported) for prophylaxis. Other suspect therapies included second dose ADACEL intramuscularly in the left arm, lot # U5458BA, manufacturer: sanofi Pasteur, Sixth dose of FLUZONE QUADRIVALENT intramuscularly in the right arm, lot # UT5673KA, manufacturer: sanofi Pasteur and first dose of MENACTRA intramuscularly in the right arm, lot # U5508AB,manufacturer: sanofi Pasteur, (dose, frequency and lot expiration date were not reported) for prophylaxis. On 29-SEP-2016 at PE the patient received second dose (extra dose administered) as a part of 11 year old vaccines. The outcome of extra dose administered was reported as recovered/resolved. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9
Symptoms: Blood glucose decreased, Condition aggravated, Hyperglycaemia, Hypoglycaemia, Immediate post-injection reaction
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA (HA# 673669) under the Freedom of Information Act on 10-MAY-2017, referring  to a 11 year old female patient. The patient's medical history included type 1 diabetes mellitus (IDDM), concomitant therapies included insulin. There was no current illness. On 06-DEC-2016, the patient was vaccinated in a private office/hospital with his third dose of GARDASIL 9 intramuscularly in the left arm, which had a lot # of M030380 (concentration, dose and expiration date was not provided), for prophylaxis. On the same day, immediately (approximately 2 hrs) after vaccination, the patient experienced typically significant issues with hyperglycemia with "sick" feeling, type 1 diabetes mellitus, immediate post-injection reaction and blood glucose decreased. Now approximately on 27-DEC-2016 (reported as "3 week"), history of (H/O) hypoglycemic episodes. Lab data "D. Stick at Home - 40's". At the time of reporting, the patient did not recovered from blood glucose decreased, type 1 diabetes mellitus, malaise, immediate post-injection reaction, hypoglycaemia and hyperglycaemia. The reporter did not provide a causality assessment between the events and GARDASIL 9. The original reporter was not provided. Additional information is not expected, as no further information could be obtained from the agency.
Sex: F
Vaccine: HPV9
Symptoms: Malaise, Type 1 diabetes mellitus
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA (HA# 673669) under the Freedom of Information Act on 10-MAY-2017, referring  to a 11 year old female patient. The patient's medical history included type 1 diabetes mellitus (IDDM), concomitant therapies included insulin. There was no current illness. On 06-DEC-2016, the patient was vaccinated in a private office/hospital with his third dose of GARDASIL 9 intramuscularly in the left arm, which had a lot # of M030380 (concentration, dose and expiration date was not provided), for prophylaxis. On the same day, immediately (approximately 2 hrs) after vaccination, the patient experienced typically significant issues with hyperglycemia with "sick" feeling, type 1 diabetes mellitus, immediate post-injection reaction and blood glucose decreased. Now approximately on 27-DEC-2016 (reported as "3 week"), history of (H/O) hypoglycemic episodes. Lab data "D. Stick at Home - 40's". At the time of reporting, the patient did not recovered from blood glucose decreased, type 1 diabetes mellitus, malaise, immediate post-injection reaction, hypoglycaemia and hyperglycaemia. The reporter did not provide a causality assessment between the events and GARDASIL 9. The original reporter was not provided. Additional information is not expected, as no further information could be obtained from the agency.
Age: 13.0
Sex: F
Vaccine: FLU4, HPV9
Symptoms: Dyskinesia, Face injury, Fall, Fatigue, Musculoskeletal stiffness
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS #675239) on 10-MAY-2017. This reports concerns a 13 year old female patient. The patient's past medical history and concomitant medications were not reported. The patient had no current illnesses. On 22-DEC-2016 the patient was vaccinated with GARDASIL 9 lot # M034780, (dosing details, expiry date were unknown) dose 2 intramuscularly in the left arm for prophylaxis. Other suspect therapy included FLUZONE (manufacturer: Sanofi Pasteur) (dosing details unknown) lot#U1709AB, administered intramuscularly in the left arm for prophylaxis. The patient was given the vaccines in the seated position at private doctor's office/hospital. On 22-DEC-2016, about a minute after vaccination, the patient experienced very stiff, with arms shaking and moving, head leaning back and to the right. She then fell forward; hit her chin and face on the floor, chipping both of her front teeth and was not responsive briefly afterwards. On the same date patient also experienced fatigue. The patient was examined with VSS (Vital Signs Stable), BP (blood pressure) and O2 saturation; all were WNL (within normal limits), Heart and lung were also WNL. The patient had good pulses. The patient was pale in color after the event. 911 was called and the patient was transferred to hospital by ambulance for further evaluation. The MD was called in the ER (emergency department). ED report: dx tooth #8, #9 fracture: tooth #8 - Diagonal Ellis Class 2 fracture; tooth #9 -Ellis Class 3 fracture at gum line with exposed pulp. Treatment given to the patient included application of calcium hydroxide cement paste to exposed root/pulp of tooth #9. The patient needs further repair/reconstruction and possible implants and needs to see trauma as well. The outcome of the events was reported as recovered. The causality assessment was not provided. The agency considered the events as non-serious. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: FLU4, HPV9
Symptoms: Pallor, Posture abnormal, Tooth fracture, Tremor, Unresponsive to stimuli
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS #675239) on 10-MAY-2017. This reports concerns a 13 year old female patient. The patient's past medical history and concomitant medications were not reported. The patient had no current illnesses. On 22-DEC-2016 the patient was vaccinated with GARDASIL 9 lot # M034780, (dosing details, expiry date were unknown) dose 2 intramuscularly in the left arm for prophylaxis. Other suspect therapy included FLUZONE (manufacturer: Sanofi Pasteur) (dosing details unknown) lot#U1709AB, administered intramuscularly in the left arm for prophylaxis. The patient was given the vaccines in the seated position at private doctor's office/hospital. On 22-DEC-2016, about a minute after vaccination, the patient experienced very stiff, with arms shaking and moving, head leaning back and to the right. She then fell forward; hit her chin and face on the floor, chipping both of her front teeth and was not responsive briefly afterwards. On the same date patient also experienced fatigue. The patient was examined with VSS (Vital Signs Stable), BP (blood pressure) and O2 saturation; all were WNL (within normal limits), Heart and lung were also WNL. The patient had good pulses. The patient was pale in color after the event. 911 was called and the patient was transferred to hospital by ambulance for further evaluation. The MD was called in the ER (emergency department). ED report: dx tooth #8, #9 fracture: tooth #8 - Diagonal Ellis Class 2 fracture; tooth #9 -Ellis Class 3 fracture at gum line with exposed pulp. Treatment given to the patient included application of calcium hydroxide cement paste to exposed root/pulp of tooth #9. The patient needs further repair/reconstruction and possible implants and needs to see trauma as well. The outcome of the events was reported as recovered. The causality assessment was not provided. The agency considered the events as non-serious. Additional information has been requested.
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Abnormal behaviour, Blood glucose normal, Blood pressure decreased, Dizziness, Fall
Clinical narrative: This initial spontaneous report was received from a heathcare professional via the Agency from a Freedom of Information line listing (VAERS ID 675509) referring to a 16 year old male patient.  The patient had no concurrent illnesses and was taking no concomitant medications. On 23-DEC-2016, the patient received GARDASIL 9 intramuscularly in the right arm (lot # M017983) and MENVEO intramuscularly in the right arm (lot # X16013). On 23-DEC-2016, patient went to lab to draw blood and while was sitting in the chair started to feel faint, and looked pale while slipping out of lab chair. Pt was raised into chair. BP had dropped and FS 88. Eyes were open and he was responsive and was given fluids, apple juice and allowed to lie down. Pt was observed for over 1 hour and recovered and was discharged home. On follow-up call 28-DEC-2016 to see how pt is, mother reports child is still not himself, had a headache, sore throat and slight temperature for past few days.  So mother was recommended to bring child to ER now for further evaluation. Additional information is not expected.
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Headache, Oropharyngeal pain, Pallor, Pyrexia
Clinical narrative: This initial spontaneous report was received from a heathcare professional via the Agency from a Freedom of Information line listing (VAERS ID 675509) referring to a 16 year old male patient.  The patient had no concurrent illnesses and was taking no concomitant medications. On 23-DEC-2016, the patient received GARDASIL 9 intramuscularly in the right arm (lot # M017983) and MENVEO intramuscularly in the right arm (lot # X16013). On 23-DEC-2016, patient went to lab to draw blood and while was sitting in the chair started to feel faint, and looked pale while slipping out of lab chair. Pt was raised into chair. BP had dropped and FS 88. Eyes were open and he was responsive and was given fluids, apple juice and allowed to lie down. Pt was observed for over 1 hour and recovered and was discharged home. On follow-up call 28-DEC-2016 to see how pt is, mother reports child is still not himself, had a headache, sore throat and slight temperature for past few days.  So mother was recommended to bring child to ER now for further evaluation. Additional information is not expected.
Sex: M
Vaccine: HPV9, MNQ, TDAP, HPV9, MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA (HA# 679242) under the Freedom of Information Act on 10-MAY-2017 and refers to a 11 year old male patient. There were no concomitant therapies, concurrent conditions and medical history. On 18-JAN-2017, the patient was vaccinated with a dose of GARDASIL 9 in his left arm (route, concentration, expiration date and indication were not provided) which had a lot # of M017983. Other suspect therapies included ADACEL in his right arm (route, concentration, expiration date and indication were not provided) which had a lot # of UI565AA and MENACTRA in his right arm (route, concentration, expiration date and indication were not provided) which had a lot # of U5410AA. On the same day, the patient experienced right swollen deltoid and redness. On 19-JAN-2017, the patient experienced warm to the touch. Therefore, the patient attended to the emergency room. At the time of reporting, the patient recovered from injection site erythema, injection site warmth and injection site swelling on an unknown date. The original reporter was not provided. The reporter did not provide a causality assessment between the suspect therapies and the adverse events. Additional information is not expected, as no further information could be obtained from the Agency.
Age: 68.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site induration, Injection site pruritus, Injection site swelling, Injection site urticaria
Clinical narrative: This spontaneous report was received from a nurse and physician referring to a 68 year old female patient (retired).  The patient had no pre-existing allergies, birth defects or medical conditions. On 10-MAY-2017 at 11:21, the patient was vaccinated with the first dose of PNEUMOVAX 23 (lot # N003993, expiration date and dose unknown) in the left deltoid for prophylaxis. The patient had no illness at time of the vaccination. The patient returned to the doctor's office approximately 4 hours after insertion with itchy swelling at injection site and a 10 centimeter indurated hive like swelling on left deltoid. The treatment recommendations were ice, elevation and prednisone (10 mg,qdx5 days).  The outcome of the events was reported as recovered in May 2017. The causal relationship between the events and PNEUMOVAX 23 was unknown. Additional information has been requested.
Age: 19.0
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Underdose
Clinical narrative: This spontaneous report was received from an office manager and refers to 19 year old patient of unknown gender. There was no information about the patient's pertinent medical history and drug reactions or allergies. On 07-APR-2017, the patient was vaccinated with a pediatric dose of VAQTA (first dose) 25/0.5 (units were not provided) (lot # M047658 , expiration date: 20-OCT-2017, site and route of administration were not provided). 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 as received from a Medical Assistant refers to an unspecified amount of patients (ages and gender unknown).  The patients' medical histories, concurrent conditions and concomitant medication use were not provided.  On multiple unknown dates since 17-MAR-2017, an unspecified amount of patients were vaccinated with improperly stored VARIVAX (lot# M041513, expiration date 11-OCT-2018), (dose and route unknown) for prophylaxis.  Information regarding temperature excursion of vaccine; temperature and time frame:  47 degrees Fahrenheit to 77 degrees Fahrenheit for two hours.  There was no previous temperature excursion and data logger was not involved.  No adverse effects were reported. The outcome of the event was unknown. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received on 10-MAY-2017 from a licensed practical nurse regarding a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapy were not reported. On 10-MAY-2017 the patient inadvertently received an expired dose of M-M-R II lot # M032153 expiration 22-APR-2017 subcutaneous for prophylaxis. Concomitant therapies included reconstituted with sterile diluent (STERILE DILUENT) lot # M022416 expiration 17-DEC-2018. No adverse effects reported. No further information available. Additional information has been requested.
Sex: U
Vaccine: PNC13
Symptoms: Injection site pain
Clinical narrative: This is a spontaneous report obtained from a contactable Health Care Professional  through a Pfizer sales representative. A patient of an unspecified age, gender, race and ethnicity received PREVNAR 13 on an unknown date, single dose, for immunization. Relevant medical history and concomitant medications were unknown. The patient previously received etanercept (ENBREL) for rheumatoid arthritis and PNEUMOVAX for immunization. On an unspecified date, 7 days after administration of pneumococcal 13-val conj vac (dipht crm197 protein), the patient experienced pain at injection site. Clinical outcome of the event was unknown at time of this report.
Age: 10.0
Sex: M
Vaccine: HEPA, HPV9
Symptoms: Asthenia, Chills, Fatigue, Headache, Pyrexia
Clinical narrative: "Had a fever of 101.3, chills and a headache. Tylenol and Ibuprofen did not bring his fever down." "Felt like jello- was tired on second day." "No reaction after his first Hep A shot or HPV shot."
Age: 32.0
Sex: M
Vaccine: DTAP
Symptoms: Fatigue, Influenza like illness, Injection site pain
Clinical narrative: Pain in shot site, flu like symptoms for 3 days then very tired for the last week.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: REDNESS, PAIN, ITCHING AT INJECTION SITE.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Erythema, Headache, Urticaria
Clinical narrative: Hives, Redness, headaches.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to unspecified number of patients of unknown age and gender. The patients' medical history, allergies and concurrent conditions were not reported. On unknown dates, the patients were vaccinated with improperly stored doses (number of doses unspecified) of VARIVAX injection, for prophylaxis (lot # M015731, expiration date: 30-MAR-2018; dose and route of administration were not reported). The vaccine was reconstituted with sterile diluent (STERILE DILUENT) solution for injection/infusion. No adverse effects were reported. The vaccine was exposed to a temperature of 6° degrees Fahrenheit (F) to 14°F for a time frame of 1.5 hours. A previous temperature excursion was reported with 15°F to 46°F for 30 minutes. Digital data logger was not involved. Furthermore, no product quality complaint (PQC) was involved. Additional information is not expected because there is no consent to contact the reporter.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant concerning to multiple unspecified patients of unknown age and gender.  On multiple unspecified dates, the patients were vaccinated with improperly stored doses of VARIVAX lot # M042857 with expiration date on 21-OCT-2018 (the route, strength, frequency and dose were not provided), reconstituted with properly stored sterile diluent with lot # reported as M001209 with expiration date on 29-JUL-2018 or lot# M 006117 with expiration date on 24-AUG-2018 for prophylaxis. It was reported that the vaccine was exposed to temperature of 6°F to 14°F for a time frame of 36 hours and a temperature of 15°F to 46° F for a time frame of 37 hours. No previous temperature excursions were reported. No adverse effects were reported. There was no product quality complaint involved. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a female patient of an unknown age. No information regarding the patient's concurrent conditions, concomitant therapies and medical history was reported. On an unknown date in May 2017 (reported as "on 01-MAY-2017 or 09-MAY-2017"), the patient was vaccinated with PNEUMOVAX 23 lot# N003997, expiration date: 22-OCT-2018 (dose, route of administration were not reported). On an unknown date in May 2017 (reported as "on 02-MAY-2017 or 10-MAY-2017" and "the day after"), the patient experienced cellulitis on the back of her right arm. The patient sought medical attention and was treated with unspecified antibiotics. There was no lab diagnostic studies performed. The outcome of cellulitis was reported as not recovered. The causality between PNEUMOVAX 23 and cellulitis was not provided. Upon internal review, the event of cellulitis was considered to be medically significant. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1705USA007145: US-009507513-1705USA009127.
Sex: U
Vaccine: FLU3
Symptoms: Feeling abnormal, Fibromyalgia, Malaise, Myalgia
Clinical narrative: Initial solicited case received on 01 May 2017 from a Consumer. This case involves a patient (unknown age and gender) who was vaccinated with FLUZONE HD on an unspecified date (route and site of administration, batch number, expiry date, dose, were not reported). The patient's medical history and concomitant therapies were not reported. On an unspecified date, (unknown latency), following the vaccination the patient developed fibromyalgia, Muscle pain, brain fog. The patient reported that "flu shots made the subject ill. The subject had fibromyalgia and a flu shot flattened the subject for a week. The subject also had muscle pain, brain fog". The lab data and corrective treatment details were not reported. The outcome of the events was not reported at the time of report. Relationship to investigational product according to company: not associated. Relationship to investigational product according to reporter: not reported. List of documents held by sender: none.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site urticaria
Clinical narrative: Right Thigh area. Welts, hard, redness to the site.
Age: 1.0
Sex: M
Vaccine: HEPA, HIBV, MMR, VARCEL
Symptoms: Erythema, Rash, Skin warm
Clinical narrative: Dark red circle, raised small bumps, warm to the touch. started getting smaller and lighter day 5.
Age: 1.08
Sex: M
Vaccine: RV5
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Vomiting and diarrhea.
Age: 34.0
Sex: F
Vaccine: DTAP
Symptoms: C-reactive protein, Chest X-ray, Chest discomfort, Chills, Confusional state
Clinical narrative: C/o waking up with fever/chills, migraine, sore/swollen arm around injection site, confusion, SOB, chest heaviness, stiff neck. Lasted 45 minutes.
Age: 34.0
Sex: F
Vaccine: DTAP
Symptoms: Differential white blood cell count, Dyspnoea, Electrocardiogram, Full blood count, Injection site pain
Clinical narrative: C/o waking up with fever/chills, migraine, sore/swollen arm around injection site, confusion, SOB, chest heaviness, stiff neck. Lasted 45 minutes.
Age: 34.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site swelling, Migraine, Musculoskeletal stiffness, Pyrexia, Troponin
Clinical narrative: C/o waking up with fever/chills, migraine, sore/swollen arm around injection site, confusion, SOB, chest heaviness, stiff neck. Lasted 45 minutes.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Pyrexia
Clinical narrative: Patient started to run fever up to 102.8.
Age: 13.0
Sex: F
Vaccine: FLU4, HPV9
Symptoms: Epstein-Barr virus test, Fatigue, Headache, Memory impairment, Nuclear magnetic resonance imaging normal
Clinical narrative: Since the above date, she has had a constant 24/7 headache, constant fatigue, and short term memory problems. We have been to several doctors, but have not had anyone who can help us yet.
Age: 19.0
Sex: F
Vaccine: HEP, MENB, HEP, MENB
Symptoms: Abdominal pain, Hot flush, Lip discolouration, Nausea, Syncope
Clinical narrative: This is a spontaneous report from a contactable physician. A 18-year-old patient of an unspecified ethnicity and gender received TRUMENBA, via an unspecified route of administration, on an unspecified date, at single dose, for immunisation. The patient's medical history was not reported. Concomitant medication included unspecified hepatitis vaccine. The patient experienced hot flashes in all the body, nausea, abdominal pain, syncope and white lips on an unspecified date with outcome of unknown.
Age: 19.0
Sex: F
Vaccine: HEP, MENB, HEP, MENB
Symptoms: Abdominal pain, Alanine aminotransferase normal, Aspartate aminotransferase normal, Blood albumin normal, Blood alkaline phosphatase normal
Clinical narrative: This is a spontaneous report from a contactable physician. A 18-year-old patient of an unspecified ethnicity and gender received TRUMENBA, via an unspecified route of administration, on an unspecified date, at single dose, for immunisation. The patient's medical history was not reported. Concomitant medication included unspecified hepatitis vaccine. The patient experienced hot flashes in all the body, nausea, abdominal pain, syncope and white lips on an unspecified date with outcome of unknown.
Age: 19.0
Sex: F
Vaccine: HEP, MENB, HEP, MENB
Symptoms: Blood calcium normal, Blood chloride normal, Blood cholesterol normal, Blood creatinine normal, Blood glucose normal
Clinical narrative: This is a spontaneous report from a contactable physician. A 18-year-old patient of an unspecified ethnicity and gender received TRUMENBA, via an unspecified route of administration, on an unspecified date, at single dose, for immunisation. The patient's medical history was not reported. Concomitant medication included unspecified hepatitis vaccine. The patient experienced hot flashes in all the body, nausea, abdominal pain, syncope and white lips on an unspecified date with outcome of unknown.
Age: 19.0
Sex: F
Vaccine: HEP, MENB, HEP, MENB
Symptoms: Blood potassium normal, Blood sodium normal, Blood triglycerides normal, Blood urea decreased, Fall
Clinical narrative: This is a spontaneous report from a contactable physician. A 18-year-old patient of an unspecified ethnicity and gender received TRUMENBA, via an unspecified route of administration, on an unspecified date, at single dose, for immunisation. The patient's medical history was not reported. Concomitant medication included unspecified hepatitis vaccine. The patient experienced hot flashes in all the body, nausea, abdominal pain, syncope and white lips on an unspecified date with outcome of unknown.
Age: 19.0
Sex: F
Vaccine: HEP, MENB, HEP, MENB
Symptoms: Hot flush, Nausea, Protein total normal, Suture insertion, Tooth extraction
Clinical narrative: This is a spontaneous report from a contactable physician. A 18-year-old patient of an unspecified ethnicity and gender received TRUMENBA, via an unspecified route of administration, on an unspecified date, at single dose, for immunisation. The patient's medical history was not reported. Concomitant medication included unspecified hepatitis vaccine. The patient experienced hot flashes in all the body, nausea, abdominal pain, syncope and white lips on an unspecified date with outcome of unknown.
Age: 19.0
Sex: F
Vaccine: HEP, MENB, HEP, MENB
Symptoms: Toothache, Wound
Clinical narrative: This is a spontaneous report from a contactable physician. A 18-year-old patient of an unspecified ethnicity and gender received TRUMENBA, via an unspecified route of administration, on an unspecified date, at single dose, for immunisation. The patient's medical history was not reported. Concomitant medication included unspecified hepatitis vaccine. The patient experienced hot flashes in all the body, nausea, abdominal pain, syncope and white lips on an unspecified date with outcome of unknown.
Age: 7.0
Sex: U
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Information had been received on 01-MAY-2017 from a nurse who reported that an unspecified patient was given GARDASIL (dosage, lot#/expiration not reported) on an unspecified day in June 2013 when the patient was seven years old. Nurse reported that GARDASIL 9 (lot# M013636, expiration 15-FEB-2018) was administered to the patient today, 01-MAY-2017. No adverse effects reported. No further information provided. Additional information has been requested.
Age: 16.0
Sex: U
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report has been received from a registered nurse concerning a 16 year old patient of unknown gender. The patient's medical history, drug allergies, concurrent conditions and concomitant therapies were not reported. On 02-MAY-2017, the patient who was indicated to receive a pediatric dose of VAQTA, received, in error, an adult dose of VAQTA with lot number N002921 and expiration date on 08-APR-2018 (dose and dose number were not provided), administered intramuscularly in the right arm for prophylaxis. The reporter also stated that the ordering healthcare provider thought that the dose should be based on the patient's weight, rather than age. The patient was observed for approximately 15 to 30 minutes after the incorrect dose was administered, and the patient tolerated the dose. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Extra dose administered, Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received on 04-MAY-2017 from a medical assistant regarding an unspecified number of unspecified patients of unknown ages and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. On unknown dates, an unspecified number of unspecified patients were inadvertently administered 4 doses of LIQUID PEDVAXHIB (lot numbers and expiration dates not reported), intramuscular for prophylaxis.  The medical assistant reported that for "more than 3 years", her office has routinely been administering doses of LIQUID PEDVAXHIB to patients at 2 months, 4 months, 6 months and at 9 or 12 months of age. No adverse effect reported. No further information was provided.  Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to multiple unspecified patients of unknown age and gender. The concurrent conditions, medical history and concomitant therapies of the patients were not reported. On unknown dates over an unspecified period of time,  the patients were vaccinated with an improperly stored dose of ROTATEQ orally, with either lot number M038728 and expiration date of 25-APR-2018 or M011832 and expiration date of 25-JAN-2018(strength and dose were unknown) for prophylaxis, which was stored from 32 Fahrenheit degrees (°F) to 35°F for 15 hours and 30 minutes. There was  previous temperature excursion. However, the temperature excursions were not detected by a data logger. No adverse effects were reported. This is one of several cases received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1705USA010439:  US-009507513-1705USA010440:
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to an unspecified number of patients of an unknown age and gender. There was no information about the patients' pertinent medical history, concurrent conditions, concomitant therapies, and drug reactions or allergies. The reporter stated that improperly stored doses of PROQUAD lot number M042501, expiration date 17-APR-2018 (strength, dose, frequency, route of administration, and anatomical location were not provided), were administered to an unspecified number of patients from 04-APR-2017 to 12-MAY-2017, for prophylaxis. It was reported that the vaccine was reconstituted with a sterile diluent (manufacturer unknown) lot number reported as N007760, expiration date reported as 31-JUN-2018 (strength, dose, frequency, route of administration, and anatomical location were not provided), which was not improperly stored, also for prophylaxis. The vaccine was exposed to a temperature between - 14 and -10 Celsius degrees for 72 hours. There was no previous temperature excursion and the call was not because of a "data logger". No adverse reactions reported. There was no product quality complaint involved. This is one of two reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1705USA010445.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to an unspecified patient of unknown age and gender. There was no information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies provided. On 25-JAN-2017, the patient was vaccinated with improperly stored dose of VARIVAX lot # M005974, expiration date 02-FEB-2018 (site, dose and route of administration were not reported). The reason of the call was temperature alarm received via Digital Data Logger. It was reported that the vaccine were exposed to temperature of -14.4 Celsius degrees for 54 minutes before administration. No previous temperature excursion was reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected because all information was obtained.; Sender's Comments:  US-009507513-1611USA004113:
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to an unspecified patient of unknown age and gender. There was no information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies provided. On 13-FEB-2017, the patient was vaccinated with improperly stored dose of VARIVAX lot # M005974, expiration date 02-FEB-2018 (site, dose and route of administration were not reported). The reason of the call was temperature alarm received via Digital Data Logger. It was reported that the vaccine were exposed to temperature of -14.4 Celsius degrees for 54 minutes before administration. No previous temperature excursion was reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected because all information was obtained.; Sender's Comments: US-009507513-1611USA004113:
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to an unspecified patient of unknown age and gender. There was no information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies provided. On 24-JAN-2017, the patient was vaccinated with improperly stored dose of VARIVAX lot # M005974, expiration date 02-FEB-2018 (site, dose and route of administration were not reported). The reason of the call was temperature alarm received via Digital Data Logger. It was reported that the vaccine were exposed to temperature of -14.4 Celsius degrees for 54 minutes before administration. No previous temperature excursion was reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected because all information was obtained.; Sender's Comments: US-009507513-1611USA004113:
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to an unspecified patient of unknown age and gender. There was no information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies provided. On 06-FEB-2017, the patient was vaccinated with improperly stored dose of VARIVAX lot # M005974, expiration date 02-FEB-2018 (site, dose and route of administration were not reported). The reason of the call was temperature alarm received via Digital Data Logger. It was reported that the vaccine were exposed to temperature of -14.4 Celsius degrees for 54 minutes before administration. No previous temperature excursion was reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected because all information was obtained.; Sender's Comments: US-009507513-1611USA004113:
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to an unspecified patient of unknown age and gender. There was no information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies provided. On 07-MAR-2017, the patient was vaccinated with improperly stored dose of VARIVAX lot # M005974, expiration date 02-FEB-2018 (site, dose and route of administration were not reported). The reason of the call was temperature alarm received via Digital Data Logger. It was reported that the vaccine were exposed to temperature of -14.4 Celsius degrees for 54 minutes before administration. No previous temperature excursion was reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected because all information was obtained.; Sender's Comments: US-009507513-1611USA004113:
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to multiple unspecified patients of unknown age and gender. The concurrent conditions, medical history and concomitant therapies of the patients were not reported. On unknown dates over an unspecified period of time,  the patients were vaccinated with an improperly stored dose of GARDASIL 9 with either lot number M024261 and expiration date of 30-JUL-2018 or M034780 and expiration date of 15-APR-2019(strength, route of administration and dose were not reported) for prophylaxis, which was stored between 32 Fahrenheit degrees (°F) to 35°F for 15 hours and 30 minutes. There was  previous temperature excursion. However, the temperature excursions were not detected by a data logger. No adverse effects were reported. This is one of several cases received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1705USA010440: US-009507513-1705USA006606:
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to multiple unspecified patients of unknown age and gender. The concurrent conditions, medical history and concomitant therapies of the patients were not reported. On unknown dates over an unspecified period of time, the patients were vaccinated with an improperly stored dose of MMR II with lot number L041457 and expiration date of 22-OCT-2017 (strength, route of administration and dose were not reported) for prophylaxis, which was stored between 32 Fahrenheit degrees (°F) to 35°F for 15 hours and 30 minutes. There was previous temperature excursion. However, the temperature excursions were not detected by a data logger. No adverse effects were reported. This is one of several cases received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1705USA006606: US-009507513-1705USA010439.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to an unspecified number of patients of an unknown age and gender. There was no information about the patients' pertinent medical history, concurrent conditions, concomitant therapies, and drug reactions or allergies. The reporter stated that improperly stored doses of VARIVAX lot number M012990, expiration date 14-MAR-2018 (strength, dose, frequency, route of administration, and anatomical location were not provided), were administered to an unspecified number of patients from 04-APR-2017 to 12-MAY-2017, for prophylaxis. It was reported that the vaccine was reconstituted with a sterile diluent (manufacturer unknown) lot number reported as N007760, expiration date reported as 31-JUN-2018 (strength, dose, frequency, route of administration, and anatomical location were not provided), which was not improperly stored, also for prophylaxis. The vaccine was exposed to a temperature between - 14 and -10 Celsius degrees for 72 hours. There was no previous temperature excursion and the call was not because of a "data logger". No adverse reactions reported. There was no product quality complaint involved. This is one of two reports received from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1705USA007449:
Age: 81.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Pain in extremity
Clinical narrative: This is a spontaneous report from a non-contactable nurse reporting on herself. An 81-year-old female patient started to receive PREVNAR 13 IM (assumed by reporter) at single dose at left arm on 04May2017 between 11:00 and 11:30 for immunization, at the doctor's office. Medical history included allergy in the spring, she gets the seasonal king on sinus allergies, but that is it and she doesn't take any medications for it, sensitive skin. Concomitant medication included vitamins and maybe a ADVIL here and there. She has had 2 previous Pneumococcal vaccines (not PREVNAR 13) in 2003 and 2011, and she did not have any reaction to them. No additional vaccines were administered on same date of the suspect. The patient experienced left arm sore on 04May2017 with outcome of recovered, and injection site became very itchy, was a little red, and had some swelling that looked almost like a mosquito bite on 11May2017 with outcome of recovered. No event required a visit to Emergency Room or Physician Office. She asked the doctor if she would have any side effects from the vaccine. He said that her arm would be sore, but that was it. She also received a paper that listed all the possible side effects, which she read through before receiving the vaccine. Her arm was sore after receiving the vaccine for the first day, but she got along fine. The soreness has resolved completely, but she is unable to provide a date. About a week later, in the evening, the injection site became very itchy, was a little red, and had some swelling that looked almost like a mosquito bite. The site was itchy for about 1.5 days, resolving on 13May2017. The swelling, which started on the evening of 11May2017, worsened on 12May2017, and resolved on 13May2017. On Saturday, 13May2017, there was still a little soreness, but the site was now more red. The area of redness was round and between 1-2 inches. States that the site isn't bothering her much now, but the redness is still there. The initial itching and the swelling was the big thing that she wanted to report. She did have sensitive skin, so she didn't know if that would be a factor. She had not spoken with her physician yet regarding the reaction. This occurred over the weekend. If it had gotten worse, she would have gone to the urgent care center, but it has been improving so she is just keeping an eye on it. A product complaint was filed. The reporter considered there was a reasonable possibility that the events left arm sore and a little swelling were related to the suspect medication.
Sex: U
Vaccine: PNC13
Symptoms: Malaise
Clinical narrative: This is a spontaneous report from a contactable pharmacist reported for a patient that: A patient of unspecified age ethnicity and gender received PREVNAR 13 via an unspecified route of administration on at  0.5, ml, single an unspecified date for immunization (Pneumonia invasive disease). The patient medical history and concomitant medications were not reported.  On an unspecified date the patient got sick and went to the hospital after receiving the vaccine with outcome of unknown. The reporter did not provide if the patient was hospitalized or just got treated in the ER. Sender's Comments: The current information is very limited and does not allow a full medically meaningful assessment, especially lack of the following: complete medical history, concomitant medications, and event details including the actual reason for being sick and the time lag between the onset of the event and vaccination date of PREVENAR 13. Assessment is postponed after receipt of a more complete case report. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Injection site rash
Clinical narrative: This is a spontaneous report from a contactable consumer reported via a Pfizer employee. A 16 years old male patient received TRUMENBA on 17May2017, at single dose, in left deltoid, for immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced rash around injection on 17May2017. The reporter's sister sent him a picture and based on that, the rash was in a big oval and it was about 6 inches long and 4 inches wide. The event had not yet resolved at the time of report. The rash was getting worse and the patient was going to the doctor. No follow-up attempts possible. No further information expected.
Age: 92.0
Sex: F
Vaccine: PNC13
Symptoms: Arthralgia, Erythema, Eye pruritus, Injection site cellulitis, Rash
Clinical narrative: Rash, aching joints, itchiness of eyes, redness/swelling of face, cellulitis at injection site.
Age: 92.0
Sex: F
Vaccine: PNC13
Symptoms: Swelling face
Clinical narrative: Rash, aching joints, itchiness of eyes, redness/swelling of face, cellulitis at injection site.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Decreased appetite, Nitrite urine absent, Pyrexia, Urine analysis normal, Vomiting
Clinical narrative: Patient received 4 month vaccines on 04/20/2017 and that night he developed fever through the evening up to 102. Fever responded to TYLENOL but has been vomiting with it. He has been more spitty than normal and had an episode of vomiting not related to the TYLENOL dose (3 episodes total, 2 w/TYLENOL). Appetite down but good urine output. No diarrhea.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site urticaria, Vaccination site rash
Clinical narrative: Hives/rash at site of vaccination.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Angioedema, Urticaria
Clinical narrative: Angioedema, hives.