chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 54.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Headache, Influenza virus test negative, Injection site erythema, Nausea, Neutrophil count increased
Clinical narrative: Case number PHHY2015US173915, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 606358) on 29 Dec 2015. This report refers to a 54 years old female patient. Historical conditions included specific antibody deficiency, IgA deficiency, lupus, autoimmune thyroid, celiac disease, T cell large granular lymphocytic leukemia, neutropenia, complex kidney cyst and recurrent vaginal intraepithelial neoplasia. Concomitant medications included PLAQUENIL, monthly immunoglobulin (unspecified) intravenously, ARMOUR thyroid (manufacturer unknown), probiotic (manufacturer unknown) and iron and multivitamin (unspecified) supplements. She was vaccinated with second dose of seasonal influenza vaccine (unknown manufacturer, batch number and expiry: not reported) into the left arm and Pneumo (pneumococcal vaccine) (unknown manufacturer, batch number and expiry: not reported) into the left arm; on 30 Oct 2015. On 31 Oct 2015, she experienced temperature 101 degree, vomiting, red line circling halfway across upper left bicep where injection was made, dizziness and near syncope, nausea, headache and very sore left arm. Laboratory data included flu swabs negative, absolute neutrophil count was 8.1, electrocardiogram was normal, troponins were normal, estimated glomerular infiltration rate was 75 and there were traces of blood and protein in urine. The outcome of the events was reported as complete recovery on an unknown date. The events were assessed as non serious and causality was not reported.
Age: 54.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Pain in extremity, Presyncope, Protein urine present, Troponin normal, Vomiting
Clinical narrative: Case number PHHY2015US173915, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 606358) on 29 Dec 2015. This report refers to a 54 years old female patient. Historical conditions included specific antibody deficiency, IgA deficiency, lupus, autoimmune thyroid, celiac disease, T cell large granular lymphocytic leukemia, neutropenia, complex kidney cyst and recurrent vaginal intraepithelial neoplasia. Concomitant medications included PLAQUENIL, monthly immunoglobulin (unspecified) intravenously, ARMOUR thyroid (manufacturer unknown), probiotic (manufacturer unknown) and iron and multivitamin (unspecified) supplements. She was vaccinated with second dose of seasonal influenza vaccine (unknown manufacturer, batch number and expiry: not reported) into the left arm and Pneumo (pneumococcal vaccine) (unknown manufacturer, batch number and expiry: not reported) into the left arm; on 30 Oct 2015. On 31 Oct 2015, she experienced temperature 101 degree, vomiting, red line circling halfway across upper left bicep where injection was made, dizziness and near syncope, nausea, headache and very sore left arm. Laboratory data included flu swabs negative, absolute neutrophil count was 8.1, electrocardiogram was normal, troponins were normal, estimated glomerular infiltration rate was 75 and there were traces of blood and protein in urine. The outcome of the events was reported as complete recovery on an unknown date. The events were assessed as non serious and causality was not reported.
Age: 59.0
Sex: F
Vaccine: FLUX
Symptoms: Hypoaesthesia, Injection site hypoaesthesia
Clinical narrative: Case number PHHY2015US173752, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 606491) website on 29 Dec 2015. This report refers to a 59-year-old female patient. Current condition included (COPD) chronic obstructive pulmonary disease. Concomitant medication included: ADVAIR, PROAIR, omeprazole (manufacturer unknown), Bupropion XL, ATROVENT HFA, fluoxetine (manufacture unknown), amlodipine besylate (manufacturer unknown), COREG CR. The patient was vaccinated with seasonal influenza vaccine (manufacturer unknown and batch number: not reported) on 28 Oct 2015. On 29 Oct 2015, it was reported that after flu shot administered to right upper arm, upper arm, neck and face on right is numb. Still had not gone away but has subsided some. The patient did not seek any treatment. The outcome of the events was condition improving. Seriousness was reported as non-serious and causality was not reported.
Sex: U
Vaccine: FLUX, VARZOS
Symptoms: Pruritus
Clinical narrative: Case number PHHY2015US173751, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 606806) website on 29 Dec 2015. This report refers to a patient of unknown age and gender. Past medical history and concomitant medication was not reported. The patient was vaccinated with seasonal influenza vaccine manufacturer unknown, batch number: not reported) along with ZOSTAVAX (other manufacture, batch number: not reported) on an unknown date. On an unspecified date, the patient experienced local itching. No further information was provided. The outcome was not reported. The seriousness of reporting as non serious and causality was not reported.
Sex: U
Vaccine: FLUX, VARZOS
Symptoms: Pruritus
Clinical narrative: Case number PHHY2015US173900, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 606809) website on 29 Dec 2015. This report refers to a patient of an unknown age and an unknown gender. Medical history was not reported. Concomitant medication included ZOSTAVAX. The patient was vaccinated with seasonal influenza vaccine (manufacture unknown, batch number: not reported) on an unknown date. On an unspecified date, the patient developed pruritus that lasted between 2 and 3 months. The outcome of the event was unknown. The seriousness was reported as non serious and causality not reported.
Age: 57.0
Sex: F
Vaccine: FLUC3
Symptoms: Blood urine present
Clinical narrative: Case number PHHY2016US011230, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 607030) on 18 Jan 2016. This report refers to a 57 years old female patient. Medical history and current illness were none. Concomitant medications were none. The patient was vaccinated with FLUCELVAX (batch number: 173906) intramuscularly into left arm on 02 Nov 2015. On 03 Nov 2015 the patient complained of blood in urine. The patient was consulting her primary care physician. Outcome of the event was unknown. The case was assessed as non-serious. Causality of the event was not reported.
Age: 34.0
Sex: F
Vaccine: FLUX
Symptoms: Headache
Clinical narrative: Case number PHHY2015US173790, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS ID: 607324) website on 29 Dec 2015. This report refers to a 34-year-old female patient. Past medical history and concomitant medication were not reported. The patient was vaccinated with seasonal influenza vaccine (manufacture unknown, batch number: not reported) on 15 Oct 2015. On 17 Oct 2015 after vaccination, the patient experienced frequent headaches. The patient visited emergency room on an unknown date. The outcome of the event was reported as complete recovery. Seriousness of the event was reported as non serious and causality not reported.
Age: 10.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site pruritus, Vaccination site rash
Clinical narrative: Case number PHHY2015US173799, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS ID: 607434) website on 29 Dec 2015. This report refers to a 10-year-old female patient. Past medical history and concomitant medication were not reported. The patient was vaccinated with seasonal influenza vaccine (manufacture unknown, batch number: not reported) in to left arm on 28 Oct 2015. On 02 Nov 2015 after vaccination, the patient experienced rash at site of vaccination site and itch (on arm). It was reported as, there was a break out at vaccination site. The patient was treated with BENADRYL cream but it was ineffective at healing reaction. The final outcome of the events was reported as condition unchanged. Seriousness of the events was reported as non serious and causality not reported.
Age: 38.0
Sex: M
Vaccine: DTOX, FLUX, TTOX
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Case number PHHY2015US173732, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS ID: 607571) website on 29 Dec 2015. This report refers to a 38-year-old male patient. Past medical history and concomitant medication were not reported. The patient was vaccinated with seasonal influenza vaccine (manufacture unknown, batch number: not reported) intramuscularly into left arm and Diphtheria and Tetanus Toxoids (manufacture unknown, batch number: not reported) intramuscularly in to right arm on 03 Nov 2015. On 04 Nov 2015 after vaccination, the patient experienced chills, fever with body temperature 100 degree and body aches. The outcome of the events was reported as complete recovery. Seriousness of the events was reported as non serious and causality not reported.
Age: 66.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Injection site pain, Lymphadenopathy
Clinical narrative: Case number PHHY2015US173684, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 608145) website on 29 Dec 2015. This report refers to a 66-year-old female patient. Current conditions included bronchiectasis, asthma, high BP and atrial fibrillation. Concomitant medication included SYMBICORT, COMBIVENT, omeprazole, FLOVENT, PROZAC, Vitamin D, Multivitamin and calcium. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on 13 Oct 2015. On 14 Oct 2015, the patient experienced swollen left neck gland, painful arm where vaccine was administered and the patient was weak. The patient went to a doctor and was told that it will take a while for the events to go down. The patient's painful arm where vaccine was administered was now ok. The patient was periodically feeling weak. Final outcome of the events was not recovered. Events were reported as non-serious. Causality was not reported.
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Pain in extremity
Clinical narrative: Case number PHHY2015US173689 is an initial spontaneous report received via Vaccine Adverse Events Reporting System (VAERS reference number: 608179) on 29 Dec 2015. This report refers to a 70 year old female patient. The patient had no medical history. Her vaccination history included administration of H1N1 monovalent influenza vaccine (manufacturer and batch number: not reported) following which she had sore arm (see related case number: PHHY2015US173690). She had no current conditions and her concomitant medications were not reported. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) in the left arm on 23 Sep 2015. It was reported that the initial shot was very painful and she had soreness in arm at injection site. She took pain medications. The outcome of the event was reported as condition unchanged. The event was reported as non-serious. The causality of the event was not reported.
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Injection site pain
Clinical narrative: Case number PHHY2015US173689 is an initial spontaneous report received via Vaccine Adverse Events Reporting System (VAERS reference number: 608179) on 29 Dec 2015. This report refers to a 70 year old female patient. The patient had no medical history. Her vaccination history included administration of H1N1 monovalent influenza vaccine (manufacturer and batch number: not reported) following which she had sore arm (see related case number: PHHY2015US173690). She had no current conditions and her concomitant medications were not reported. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) in the left arm on 23 Sep 2015. It was reported that the initial shot was very painful and she had soreness in arm at injection site. She took pain medications. The outcome of the event was reported as condition unchanged. The event was reported as non-serious. The causality of the event was not reported.
Age: 54.0
Sex: F
Vaccine: FLUC3
Symptoms: Mobility decreased, Musculoskeletal pain
Clinical narrative: Case number PHHY2016US011924, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS ID: 608571) website on 18 Jan 2016. This report refers to a 54-year-old female patient. Past medical history and concomitant medication were not reported. The patient was vaccinated with FLUCELVAX (batch number: 174272) intramuscularly into left arm on 26 Oct 2015. After vaccination on 27 Oct 2015, the patient noted pain in shoulder area and was unable to lift arm. The patient used massage and yoga as treatment with some improvement but pain returned approximately 01 hour later. The final outcome of the events was not reported. Seriousness of the events was reported as non serious and causality not reported.
Age: 53.0
Sex: F
Vaccine: FLUC3
Symptoms: Headache, Induration, Peripheral swelling, Rash, Skin warm
Clinical narrative: Case number PHHY2016US011607, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 608591) website on 18 Jan 2016. This report refers to a 53-years-old female patient. Past medical history was not reported. Concomitant medications included SINGULAIR. She was vaccinated with FLUCELVAX (batch number: 15733P) in left arm on 05 Nov 2015. On 06 Nov 2015 at 02:00 AM, her arm was swollen, hard and hot. At 11:00 PM, severe headache. On 07 Nov 2015 at 06:00 AM, rash on face. She stated that headache pain was less and rash was subsiding. The final outcome of the events was reported as condition unchanged. The seriousness of the events was reported as non serious. The causality of the events was not reported.
Age: 74.0
Sex: U
Vaccine: FLUX
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: Case number PHHY2015US173746, is an initial spontaneous report received Vaccine Adverse Event Reporting System (VAERS reference number: 608749) website on 29 Dec 2015. This report refers to a 74 years old patient of unspecified gender. Past medical history and concomitant medications were not reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on an unknown date. On an unknown date, the patient experienced body chills, body aches, fever and headache. The patient treated with ibuprofen (manufacturer unknown), Aspirin and stay in bed. The outcome of events was reported as complete recovery. The seriousness of the events was reported as non-serious. The causality of the events was not reported.
Age: 16.0
Sex: F
Vaccine: FLUX, MNQ
Symptoms: Body temperature increased, Inflammation, Pruritus, Urticaria
Clinical narrative: Case number PHHY2015US174291 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 609371) on 29 Dec 2015. This report refers to a 16 year old female patient. Medical history and concomitant medications were not reported. No lab data was reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) and MENACTRA (other manufacturer, batch number: not reported), both intramuscularly into left arm on 11 Nov 2015. On 12 Nov 2015, the patient experienced inflammation, urticaria, pruritus and increase in skin temperature. The outcome of the events was reported as unknown. Events were reported as non-serious. Causality of the events was not reported.
Age: 55.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Case number PHHY2015US174293 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 609483) on 29 Dec 2015. This report refers to a 55 year old female patient. Medical history and concomitant medications were not reported. Concurrent conditions included allergy to penicillin and general hay fever allergies. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on 05 Nov 2015. On 06 Nov 2015, the patient experienced chills, fever and body aches. The outcome of the events was reported as complete recovery. Events were reported as non-serious. Causality of the events was not reported.
Age: 67.0
Sex: F
Vaccine: FLUC3
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Case number PHHY2016US007825 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 609500) website on 18 Jan 2016. This report refers to a 67 year old female patient. Medical history and concomitant medication were not reported. The patient was vaccinated with FLUCELVAX (batch number: 173906) intramuscularly in the left arm on 06 Nov 2015. On 07 Nov 2015, area was red, warm and itchy. Area involved was elbow to vaccination site. The patient did not receive medical attention when the events occurred. The patient called again on 08 Nov 2015 and reported that it looked less red but she was worried about cellulitis. The patient's symptoms resolved without medical intervention. Seriousness of the events was reported as non serious and causality was not reported.
Age: 14.0
Sex: F
Vaccine: FLUC3
Symptoms: No adverse event
Clinical narrative: Case number PHEH2016US008563 is a spontaneous report initially received from a nurse on 05 Apr 2016. This report refers to a 14 year old female patient. Past medical history and concomitant medications were not reported. This patient under the age of 18 was vaccinated with FLUCELVAX (batch number: 173991) intramuscularly in the right arm on 03 Oct 2015. The case was reported as non-serious. No adverse event was reported following this maladministration (inappropriate age at vaccine administration). Follow up information received via Vaccine Adverse Events Reporting System (VAERS reference number: 625600) on 27 Apr 2016: Updated VAERS information, site of vaccination and seriousness.
Age: 20.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: This spontaneous report was received from a pharmacy intern concerning a 20 year old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not provided. On 12-JAN-2017, the patient was vaccinated with RECOMBIVAX HB (unspecified strength, dose, and route of administration) (lot number: M039201; expiration date: 04-NOV-2018) for prophylaxis. On 13-JAN-2017, the patient came back into the pharmacy and reported that at the injection site where the RECOMBIVAX HB was administered was a "little red, itchy and had some swelling" (injection site erythema, injection site pruritus, injection site swelling). The patient treated the area with (over the counter) BENADRYL and hydrocortisone (manufacturer unknown) cream. On 14-JAN-2017, the patient recovered from the events. No product quality complaint (PQC) was involved. The reporter did not provide any causality between the events and the suspect therapy. Additional information has been requested.
Age: 17.0
Sex: M
Vaccine: TYP, YF, TYP, YF
Symptoms: Dyspnoea, Headache, Nausea, Vomiting
Clinical narrative: Within 2 hours of receiving Typhoid and Yellow Fever patient had transient chest pain, nausea, dyspnea, lasting 60-90 min. Similar symptoms after Hep A and Varicella 2/11/15. Patient asymptomatic by Appt. with me few hours. Allergy referral ordered.
Age: 17.0
Sex: M
Vaccine: TYP, YF, TYP, YF
Symptoms: Chest pain, Dyspnoea, Nausea
Clinical narrative: Within 2 hours of receiving Typhoid and Yellow Fever patient had transient chest pain, nausea, dyspnea, lasting 60-90 min. Similar symptoms after Hep A and Varicella 2/11/15. Patient asymptomatic by Appt. with me few hours. Allergy referral ordered.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On unknown dates, the patients received improperly stored doses of GARDASIL 9 lot # L037554, expiration date 25-DEC-2017 (doses and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccine underwent the temperature excursion of 9 degree Celsius for 30 minutes which was detected by a data logger. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA014067: US-009507513-1701USA014075: US-009507513-1701USA014062:
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a register nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 06-JAN-2017, the patient was vaccinated with ZOSTAVAX vial, subcutaneously (lot# L021612 and expiration date: 10-SEP-2016). The vaccination was expired. No adverse effects was reported. Additional information has been requested.
Sex: M
Vaccine: HPVX
Symptoms: Injection site pain
Clinical narrative: Information had been received on 06-JAN-2017 from a female via social media who wrote, "Both of my boys have had their HPV vaccines will no ill side effects other than the typical complaints of the injection site hurts for a few hours (so they couldn't possibly go back to school that day and needed ice cream and video games)". HPV vaccine was unspecified. Date of vaccination and adverse event was not reported. No further adverse event information was reported. Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age.  The patient's medical history, concurrent conditions and/or concomitant medications were not provided. On an unknown date the patient was vaccinated with ZOSTAVAX lot # M035694, expiration date 07-NOV-2017 for prophylaxis. The pharmacist reports that a dose of improperly stored ZOSTAVAX was administered to an unspecified patient on an unspecified date.  The dose of the vaccine was exposed to a temperature of 10 degree Fahrenheit for 12 hours.  There were two prior temperature excursions at 12 degree Fahrenheit for 11 hours and 10 degree Fahrenheit for 15 hours. Data logger was not involved. No adverse effects were 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 registered nurse refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ orally, lot # L013203 with expiration date of 28-JAN-2017, lot # L029615 with expiration date of 15-MAY-2017, lot # M004890 with expiration date of 10-NOV-2017 (dose was not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 32 to 36 degrees Fahrenheit for 40 minutes. Data logger was involved. There were no previous excursions reported. No product quality complaint was involved. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA014103.
Sex: U
Vaccine: PPV
Symptoms: Inappropriate schedule of drug administration, Wrong drug administered
Clinical narrative: This spontaneous report was received from a physician via Pfizer refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient received an unspecified flu vaccine and was told to return to the office for PREVNAR 13. On an unknown date, the patient was at a pharmacy and thought of getting the vaccination due to convenience. The patient requested a PREVNAR 13. However, the patient received PNEUMOVAX 23 since the pharmacist told the patient that both vaccines are same but latter has ten more things (Wrong drug administered and Drug dispensing error). The doctor told that the PNEUMOVAX 23 was given in the office 3 years before so the patient got two PNEUMOVAX 23 three years apart (Inappropriate schedule of drug administration), but never got a PREVNAR 13 and the patient has to wait a year to the PREVNAR 13. It was reported that the doctor's office never give two vaccines at the same time that is the way of their protocol, they never do. So they gave flu vaccine first and then they told the patient to come back for PREVNAR 13. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to 14 patients of unknown age and gender. The patients' concurrent conditions or medical history were not reported. On unspecified dates since 11-JAN-2016, improperly stored doses of M-M-R II) (lot # M017347 with expiry date of 06-APR-2018; or lot # reported as M032157 with expiry date on 07-JAN-2018; dose and route of administration were not reported) were administered to the patients. The vaccine was stored over 46 degrees Fahrenheit but under 77 degrees Fahrenheit for 1 hour and 6 minutes. There was previous temperature excursion of over 46 degrees Fahrenheit but under 77 degree Fahrenheit for 1 hour and 30 minutes. Digital data logger was not involved. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1701USA007841: US-009507513-1701USA007856: US-009507513-1701USA007855:
Sex: U
Vaccine: UNK
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to an unspecified patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medication were not provided. On an unknown date, the patient may have received improperly stored M-M-R II injection (lot # L032182, expiration date 25-AUG-2017) for (strength, dose and route were unknown), VAQTA injection (lot # M011116, expiration date 17-JUN-2017) (strength, dose and route were unknown), RECOMBIVAX HB injection (lot # M000442, expiration date 31-MAR-2018) (strength, dose and route were unknown), GARDASIL 9 injection (lot # M013636, expiration date 15-FEB-2018) (strength, dose and route were unknown), PNEUMOVAX 23 injection (lot # L048265, expiration date 10-JUN-2017) (strength, dose and route were unknown) or ROTATEQ Oral liquid (orally, lot # M031802, expiration date 09-NOV-2017) (strength and dose were unknown); all of them for prophylaxis. On an unknown date, the vaccines were exposed to a temperature excursion between 46 Farenheit degrees and 77 Farenheit degrees for 3 hours and 45 minutes. There was no previous temperature excursion. Digital Data Logger was involved. The medical assistant reported she was not sure whether the patient received the vaccine. No adverse effect were reported. Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report received from a medical assistant refers to an approximately 2-year-old patient of unknown gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions, or allergies was provided. On 03-AUG-2012 the patient was vaccinated with the first dose of M-M-R II injection (rHA; subcutaneously; lot # H014648, expiration date: 20-NOV-2013; dose was not provided), and the first dose of VARIVAX injection (subcutaneously; lot# H018788, expiration date: 15-OCT-2014; dose was not provided). Then, on 21-AUG-2013 (reported as "approximately one year later"), the patient received the second dose of M-M-R II injection (rHA; subcutaneously; lot # 0232AE, expiration date: 26-JAN-2014; dose was not provided), and the second dose of VARIVAX injection (subcutaneously; lot# 0048AE, expiration date: 20-DEC-2013; dose was not provided). No adverse events were noted by reporter. Product Quality Complaint (PQC) was not involved. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist via a company representative regarding a patient of unknown gender and age. Information regarding patient's medical history, concurrent conditions, drug reactions/allergies and concomitant therapy were unspecified. On unknown dates, the patient was vaccinated with PNEUMOVAX 23 (dosing details were unspecified) for prophylaxis. Pharmacist reported that the patient may have received more than 3 doses of vaccine, all on unspecified dates. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Information has been received from a medical assistant (also reported as a healthcare worker) referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided. On 20-JAN-2017 the patient was inadvertently vaccinated with a fourth dose of RECOMBIVAX HB injection (dose, route, site of administration, lot # and expiration date were not reported) for prophylaxis (extra dose administered). No adverse effects were reported. Product quality complaint was not involved. Additional information has been requested.
Age: 59.0
Sex: M
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. There was no information about the patient's concomitant medications, concurrent conditions and medical history reported. On 26-JAN-2017, the patient was inadvertently vaccinated with an expired dose of PNEUMOVAX 23 lot # L024129, expiry date 21-JAN-2017, intramuscularly for prophylaxis. 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 unspecified patients of unknown ages and genders. No pertinent medical history, drug reactions/ allergies or concurrent conditions were reported. On an unknown date, the patients were vaccinated with a dose of improperly stored VARIVAX, subcutaneously, lot # of M034583 and an expiration date of 27-JUL-2018, reported lot#: M035140 with expiration date: 08-AUG-2018 and reported lot # M037008 with expiration date: 25-AUG-2018 for; however, dosage number was not reported) for prevention of chickenpox at one and four year checks. Nevertheless, no adverse effects were reported.  The vaccines experienced the following temperature excursions during 19 hours of more than 8 degree Celsius but less than 25 degree Celsius. Reportedly, there had been previous temperature excursions and the aforementioned ones were identified due to a data logger. Furthermore, no product quality complaint (PQC) was involved. It was reported that the patients did not receive treatment.  Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Eye pain, Mydriasis, Neurological symptom, Ophthalmic herpes zoster, Viral test positive
Clinical narrative: This spontaneous report was received from a physician via a company representative referring to a female patient of unknown age. The patient's pertinent medical history, drug reactions, and allergies were not reported. Concomitant medications included multiple unspecified medications for pain and hypertension. On an unknown date (reported as "a couple of years ago"), the patient was vaccinated with a dose of ZOSTAVAX (Lot # and expiration date unspecified) for prophylaxis. The physician reported that the patient was experiencing pain "around her eye" and was seen at an unspecified emergency room in August 2016(reported as "about 6 months ago"), the patient also had "some neurological symptoms and a dilated pupil that resolved" on an unspecified date. Additionally, it was stated that "a physician scraped the tissue around the eye and the tissue came back positive for shingles". The patient received an unspecified treatment for the event. At the reporting time the patient present status was reported as recovered. The reporter did not assess the relationship between the event and ZOSTAVAX. Upon internal review the event of ophthalmic herpes zoster was determined to be medically significant. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On unknown dates, the patients received improperly stored doses of M-M-R II (HSA (human serum albumin)), lot # L034731 with an expiration date of 09-SEP-2017 and lot # L039613 with an expiration date of 08-OCT-2017 (doses and route of administration were not provided). There was no adverse effect reported. Administered doses of vaccine underwent the temperature excursion of 9 degrees Celsius for 30 minutes which was detected by a data logger. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA003654: US-009507513-1701USA014067: US-009507513-1701USA014075.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9, lot # L040054 with expiration date of 26-DEC-2017, lot # M018810 with expiration date of 28-MAY-2018, lot # M031557 with expiration date of 07-APR-2019 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 32 to 36 degrees Fahrenheit for 40 minutes. Data logger was involved. There were no previous excursions reported. No product quality complaint was involved. This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1701USA005915:
Age: 31.0
Sex: M
Vaccine: FLU4, FLUX
Symptoms: Influenza
Clinical narrative: Initial unsolicited report received from other non-healthcare professional on 18-JAN-2017. This case involves a male patient (Age was not reported) who was vaccinated with a dose of FLU VACCINE (dose, dose in series, batch number, expiry date, route and site of administration were not reported) on an unspecified date. The patient's medical history and concomitant medications were not reported. On an unspecified date, following vaccination the patient was diagnosed with probable influenza by personal physician. Laboratory data and corrective treatment were not reported. Outcome of event was not reported. Upon internal review, the company decided to consider the event serious because of important medical event Influenza. List of documents held by sender: none. Sender's Comments: As with any other vaccine influenza vaccine may not protect 100% of individuals. Manufacturer of the vaccine was not provided. This is poorly documented case. However, investigation results ruling out a concurrent condition and other etiologies would be helpful to further assess this case.
Age: 2.0
Sex: M
Vaccine: FLU4
Symptoms: Influenza, Influenza A virus test positive, Vaccination failure
Clinical narrative: Initial unsolicited case received from a nurse on 18 Jan 2017. This case involves a male patient (age not reported) who was vaccinated with a dose of FLUZONE QIV (Batch number, expiry date, dose, route and site of administration was not reported) on 26 Sep 2016. The patient medical history and concomitant medications were not reported. On an unknown date, Culture confirmed Flu strain A. it was case of vaccination failure. The patient other lab tests and corrective treatment was not reported. The outcome of the event was not reported. Upon internal review the company decided to consider the case serious because of important medical events Influenza A virus infection and Vaccination failure. List of documents held by sender: none. Sender's Comments: Patient was vaccinated with FLUZONE QIV vaccine and presented with influenza with culture confirmed for flu A strain. Time to onset is compatible, as patient should be protected with single dose, additional information regarding patient immune system at the time of vaccination, any defect in storage maintenance, technique while vaccine administration which may lead to vaccine ineffectiveness. Considering the temporal relation this is case of vaccination failure which cannot be ruled out as it is lab oratorically confirmed.
Age: 76.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Influenza like illness, Malaise, Pyrexia
Clinical narrative: Malaise, fever, flu-like symptoms.
Age: 0.5
Sex: U
Vaccine: HIBV, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 6 month old patient of unknown gender. The patient's concurrent conditions, medical history and drug allergies were not reported. On 02-DEC-2016, the patient was vaccinated with improperly stored PEDVAXHIB (dose and route not reported) from lot # M025192, expiry date: 21-MAR-2019, 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 temperature 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 correspondence has been received. Sender's Comments: US-009507513-1610USA014705: US-009507513-1610USA014706.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to unspecified patients of unknown age.  The patient's medical history, concurrent conditions and/or concomitant medications were not provided. On an unknown date the unspecified patients were vaccinated with VARIVAX lot # L034369, expiration date 08-SEP-2017 for prophylaxis. The healthcare worker reported that unspecified patients were administered improperly stored VARIVAX  on 07-DEC-2016 and 29-DEC-2016.  The doses of the vaccine were exposed to a temperature of 12 degree Fahrenheit for 45 hours.  There were no prior temperature excursions.  Data logger was not involved. No adverse effects were reported. No further information was provided. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a vaccine coordinator referring to an unspecified number of patients of unknown age and gender. Information regarding drug reactions, allergies, pertinent medical history and concomitant medications was not provided. On an unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 (strength, route of administration, dose, frequency, lot# and expiration date were unspecified by the reporter) for prophylaxis. A previous temperature excursion was reported with a temperature of 62F during 17 hours. Subsequently, another recent excursion was reported with a temperature of 35F during 1hour and 14 minutes. The total amount of time of the temperature excursion was 18 hours and 14 minutes. The information of excursion was registered in a digital data logger. No adverse effect was reported nor product quality complaint was not involved. Additional information has been requested.
Age: 0.75
Sex: U
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a medical technician (reported as healthcare worker) referring to a 9 month old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, concomitant therapies and drug reactions/allergies reactions were not reported. On 24-SEP-2014, the patient was vaccinated with a dose of VAQTA intramuscular, lot # K004856 and expiration date: 07-DEC-2016 (Strength and  dose were not reported) for prophylaxis (drug administered to patient of inappropriate age). No side effects were reported. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Information has been received from a registered nurse concerning a male patient of unknown age. The patient's concurrent conditions, medical histories and concomitant therapies were not reported. On 17-JAN-2017 (also reported as 4 days ago), the patient was vaccinated with a dose of ZOSTAVAX (lot #, expiration date, dose and route were unknown), for prophylaxis. On an unknown date in January 2017, the patient experienced redness and itching at injection site. There are no vesicles being reported. No treatment had been employed. The outcome of the events was unknown. The reporter did not assess the causality. Additional information is not expected as the reporter did not want to be contacted.
Sex: U
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: This spontaneous report has been received from a consumer referring to an unknown number of patients (unspecified ages and genders). The patients had no pertinent medical history, drug allergies/reactions or concomitant therapies reported. The reporter was told by a nurse practitioner, that other unspecified patients have had occurrences of fainting (Syncope) similar to the one that happened to her daughter (captured on MARRS# 1701USA001687) after being vaccinated with GARDASIL 9 regimen for prophylaxis (lot #, expiration date, dose, and anatomical location were not reported). The causality assessment between faint and the suspect product was not reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA001687:
Sex: M
Vaccine: HPV9
Symptoms: Dyspnoea, Fatigue, Hypersensitivity, Inflammation, Swelling face
Clinical narrative: Information has been received via a company representative from a nurse who was the mother of the male patient (age not reported). On an unknown dates the patient was vaccinated with dose 1, and 2 of GARDASIL 9. On an unknown date the patient was vaccinated with dose 3 of GARDASIL 9, intramuscular (site not reported) for prophylaxis. On an unknown date, after dose 1 and 2 the patient was tired. On an unknown date, after dose 3 the patient had an allergic reaction that caused swelling of the face, unspecified inflammation and experienced difficulty breathing. The patient was taken to the hospital when the adverse event occurred but the primary reporter did not known what treatment was given. The patient did not die. On an unknown date the patient recovered from hypersensitivity. The outcome of tiredness was not reported.  No product quality complaint involved. The reporter considered the event serious due to hospitalization. Upon internal review the event was also considered serious as medically significant. The relationship between hypersensitivity, tiredness and therapy with GARDASIL 9 was not reported. Additional information has been requested.
Sex: U
Vaccine: PNC13
Symptoms: Allergy to vaccine, Rash
Clinical narrative: This is a spontaneous report from a Pfizer sponsored program Pfizer RXPathways from a contactable Physician. A currently 66-year-old patient received a single dose of PREVNAR 13 via an unspecified route on unknown date for immunization. The patient medical history and concomitant medications were not reported. On unknown date the patient experienced allergy to the vaccine and rash. The outcome of the events was unknown. Follow-up (28SEP2016): Follow-up attempts are completed. No further information is expected. Follow-up (24Jan2017): New information reported from Pfizer sponsored program Pfizer RXPathways from a contactable Physician included: new event: rash.; Sender's Comments: Linked Report(s) : 2016395960 Legacy paper report number.
Age: 75.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Fatigue, Pyrexia
Clinical narrative: Uncontrolled shivering; 103 degree fever, fatigue.
Age: 1.25
Sex: F
Vaccine: DTAP, FLU4, HIBV
Symptoms: Injection site discolouration
Clinical narrative: Mottled discoloration to injection site. No pain or induration. Continues to be discolored 3 months after vaccine.
Age: 74.0
Sex: M
Vaccine: FLU3
Symptoms: Bedridden, Fatigue, Malaise, Pyrexia
Clinical narrative: Patient states felt extremely ill, fatigued, Bedridden, and also a fever for 3 days.
Age: 0.5
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 6 months old patient. The patient's concurrent conditions, medical history and drug allergies were not reported. On 08-NOV-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 correspondence has been received.; Sender's Comments: US-009507513-1610USA008140: US-009507513-1610USA014705:
Age: 0.5
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 6 month old patient. The patient's concurrent conditions, medical history and drug allergies were not reported. On 08-NOV-2016, the patient was vaccinated with improperly stored ROTATEQ, oral, (dose not reported) from lot # M014544 with expiry date: 27-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 correspondence has been received.; Sender's Comments: US-009507513-1610USA008140: US-009507513-1610USA014705: