chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site pain, Injection site swelling, Musculoskeletal pain, Tendonitis
Clinical narrative: Based on additional information received on 27 APRIL 2015 this case is now medically confirmed.  Initial unsolicited report received from a non-healthcare professional (consumer) on 19 MARCH 2015. This case was linked to 2015SA036845 (same patient). A 72-year old female patient, whose medical history and concomitant mediations were not reported, had received a dose of influenza vaccine ,dose, dose number, batch number, expiry date and site of administration was not reported) via intramuscular route on 14 SEPTEMBER 2014. It was reported that the patient is not having any illness at the time of vaccination and recovering from back surgery. It was also reported that the patient does not know what influenza vaccine she received. Stated she had pain and swelling at the injection site right away. Swelling at the site is about the size of an egg. Shoulder pain is constant with she is doing an activity. Patient can move her arm up and down without pain. No information about prior exposure to vaccine was provided.  Laboratory investigations and corrective treatments were not reported. At the time of this report the patient outcome was not recovered. Documents held by sender:  none. Follow-up information received from the physician on 27 APRIL 2015. IT was reported that the patient was injected in the right shoulder the other day and one month ago for biceps tendonitis.
Age: 19.0
Sex: M
Vaccine: FLUX
Symptoms: Ear infection, Hypoacusis
Clinical narrative: Initial unsolicited report received from a consumer on 11-March-2015. A 19-year-old male patient, whose medical history and concomitant medications were not reported, had received a dose of FLU VACCINE (batch number, expiry date, dose number, route and site of administration were not reported) on an unspecified date. On an unspecified date since vaccination, the patient experienced ear infection and hearing difficulty. Laboratory investigation and corrective treatment were not provided. At the time of report, outcome of the event was unknown. Documents held by sender: none.
Age: 43.0
Sex: M
Vaccine: FLU4
Symptoms: Concussion, Injection site pain, Musculoskeletal stiffness, Neuralgia, Post-traumatic neck syndrome
Clinical narrative: Initial unsolicited report received from a non healthcare professional on 02 APR 2015. A 44-year-old male patient had received a dose of FLUZONE QUAD in the left deltoid (batch number: UI199AB, expiry date: 30-JUN-2015, route of administration was not reported) on 02-OCT-2014 at 11 AM. The patient illness at the time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions were unknown. On 03-OCT-2014, at 07 AM, the patient developed left arm stiffness which persisted with neuralgia into arm and left ring. He was also pinky. At times, he developed pain in the left shoulder and left trapezius. He was mugged and had a concussion and whiplash injury about 3 weeks after flu sot in NOV 2014. There were no laboratory investigations and correct treatment was not reported. At the time of this report, the patient had no recovered from the above mentioned events. Documents held by sender: none.
Age: 43.0
Sex: M
Vaccine: FLU4
Symptoms: Skin discolouration
Clinical narrative: Initial unsolicited report received from a non healthcare professional on 02 APR 2015. A 44-year-old male patient had received a dose of FLUZONE QUAD in the left deltoid (batch number: UI199AB, expiry date: 30-JUN-2015, route of administration was not reported) on 02-OCT-2014 at 11 AM. The patient illness at the time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions were unknown. On 03-OCT-2014, at 07 AM, the patient developed left arm stiffness which persisted with neuralgia into arm and left ring. He was also pinky. At times, he developed pain in the left shoulder and left trapezius. He was mugged and had a concussion and whiplash injury about 3 weeks after flu sot in NOV 2014. There were no laboratory investigations and correct treatment was not reported. At the time of this report, the patient had no recovered from the above mentioned events. Documents held by sender: none.
Sex: F
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: Initial unsolicited report received from a consumer on 15 April 2015. A female patient (age at onset unknown), whose medical history and concomitant medications were not reported, had received a INFLUENZA VACCINE (batch number, route of administration, site of administration was not reported) on an unspecified date. On an unspecified date after vaccination, the patient experienced flu. Laboratory investigations and corrective treatments were not reported. At the time of this report outcome of event was unknown. Documents held by sender: none.
Sex: F
Vaccine: FLUX
Symptoms: Malaise, Vomiting
Clinical narrative: Initial unsolicited report received from a consumer on 21 April 2015. A female patient, whose medical history and concomitant medications were not reported, had received a dose of INFLUENZA VACCINE (batch number, expiry date, dose, dose number, route and site of administration were not reported) on an unspecified date. On an unspecified date, many years ago after vaccination, patient was sick and had vomiting. Laboratory investigations and corrective treatment were not reported. At the time of this report, outcome of the event was unknown. Documents held by sender: none.
Sex: M
Vaccine: FLUX
Symptoms: Burning sensation, Diarrhoea, Multiple sclerosis, Nasopharyngitis, Skin lesion
Clinical narrative: Initial unsolicited report received from a consumer on 17-Mar-2015. A male patient (age not reported), whose medical history and concomitant medications were not provided had received a dose of INFLUENZA VACCINE (batch number, dose details, expiry date, route and site of administration was not provided) on an unspecified date. On an unspecified date after vaccination, the patient developed cold. It was reported that the patient felt like he was on fire when he took Tecfidera. He also had diarrhea. He had taken Copaxone for a year and the number of lesions he had increased. He was "feeling like pin cushion" when he was on Rebif. He also took AUBAGIO for multiple sclerosis. Laboratory investigations and corrective treatments were not reported. At the time of this report, the outcome of the event: cold was reported as unknown. Documents held by sender: none.
Sex: F
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: Initial unsolicited report received from a non-healthcare professional on 28 April 2015. A female patient, whose age, medical history and concomitant medications were not reported, had received a dose of INFLUENZA VACCINE (batch number, dose, route of administration, site of administration were reported) on an unspecified date. On an unspecified date after vaccination, the patient experienced flu. Laboratory investigations and corrective treatments were not reported. At the time of this report, patient had not recovered from the event. Documents held by sender: none.
Sex: M
Vaccine: FLUX, FLUX, FLUX
Symptoms: Allergy to vaccine
Clinical narrative: Initial unsolicited report received from a non-healthcare professional on 30 March 2015 and Follow-up information received from non-healthcare professional on 19 June 2015. A male patient (age not reported), whose medical history was reported as diarrhea, tiredness and concomitant medication was not reported, had received a dose of INFLUENZA VACCINE (batch number, dose of vaccine, route and site of vaccination were not reported) on an unspecified date. It was reported that, diarrhea and tiredness which was illness at time of vaccination were not related to Flu vaccine. On an unspecified date, patient had Allergies: Flu vaccine. Laboratory investigations and corrective treatment were not reported. At the time of this report, the outcome of the event was reported as unknown. Documents held by sender: none.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed vocational nurse refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 04-NOV-2015, the patient was vaccinated with a dose of VARIVAX (Merck), lot # L021214 and expiration date 10-JUN-2017 as reported (dose, route of administration and anatomical location were not provided). There were no concomitant medications reported. No adverse effect was reported. No product quality issue was involved. This is one of several cases from the same reporter. Additional information has been requested.
Age: 80.0
Sex: F
Vaccine: FLUX
Symptoms: Disorientation, Feeling abnormal, Laboratory test abnormal, Pain, Panic attack
Clinical narrative: Initial unsolicited report received from consumer on 05 MAY 2015. An 80-year-old female patient had received a dose of INFLUENZA (batch number, expiration date, dose, dose cycle, route and site of administration were not reported) on an unspecified date in 2015. The patient medical history reported as TMJ Syndrome, obsessive-compulsive disorder, depression, anxiety, no sex in fifteen years which was still ongoing and previous medication includes 0.625 mg cream of PREMARIN (batch number: J87776, expiration date: MAY 2016, indication: vaginal dryness) squeeze from tube onto finger nightly before bed and PROZAC for depression. PAXIL, LORAZEPAM and antihypertensives and also CLONAZEPAM. The patient had also received an unknown name product medication which had an applicator as well. On an unspecified date in 2015, after vaccination patient had experienced a pain which was so bad, feeling really bad, disoriented and panic attack. Laboratory investigation includes unspecified test performed by gynecologist on an unspecified date, result reported as vaginal dryness. Corrective treatment was not reported. At the time of this report, outcome of the event was unknown. List of the documents held by sender: none.
Age: 80.0
Sex: F
Vaccine: FLUX
Symptoms: Vulvovaginal dryness
Clinical narrative: Initial unsolicited report received from consumer on 05 MAY 2015. An 80-year-old female patient had received a dose of INFLUENZA (batch number, expiration date, dose, dose cycle, route and site of administration were not reported) on an unspecified date in 2015. The patient medical history reported as TMJ Syndrome, obsessive-compulsive disorder, depression, anxiety, no sex in fifteen years which was still ongoing and previous medication includes 0.625 mg cream of PREMARIN (batch number: J87776, expiration date: MAY 2016, indication: vaginal dryness) squeeze from tube onto finger nightly before bed and PROZAC for depression. PAXIL, LORAZEPAM and antihypertensives and also CLONAZEPAM. The patient had also received an unknown name product medication which had an applicator as well. On an unspecified date in 2015, after vaccination patient had experienced a pain which was so bad, feeling really bad, disoriented and panic attack. Laboratory investigation includes unspecified test performed by gynecologist on an unspecified date, result reported as vaginal dryness. Corrective treatment was not reported. At the time of this report, outcome of the event was unknown. List of the documents held by sender: none.
Age: 46.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Neuralgia, Pain in extremity, Ultrasound scan
Clinical narrative: Based on additional information received on 7 April 2015, this case became medically confirmed. Initial unsolicited report received from a non-healthcare professional on 10 Mar 2015. A 46 year-old male patient, whose medical history, illness at the time of vaccination were none and concomitant medications were unknown, had received first dose of ADACEL (batch number C4472BA, route of administration not reported on right deltoid) on 19 Feb 2015 and also received first dose of FLUZONE (batch number U5064FA, route of administration not reported on left deltoid) on 19 Feb 2015. Prior exposure to vaccine was none and other vaccinations prior four weeks of administration was none. On 19 Feb 2015 after vaccination, the patient had pain in his right arm and later when he was seen in the office on 27 Feb 2015 he was diagnosed with nerve pain. The patient had ER/physician visit. Laboratory investigations were none and corrective treatments include pain medications and NEURONTIN. At the time of report patient had not recovered from the event. Documents held by sender: none. Follow-up information received from a healthcare professional on 7 April 2015. Patient's height was reported as 193 cm (76 inches) and it was also reported that the patient was previously vaccinated with a intramuscular dose of Tdap (batch no C4472BA exp date 27 Feb 2016) intramuscularly in right arm on 9 May 2014. Medical history was reported as no known allergies. And reporting physician's details were also updated. Laboratory investigations includes body temperature 97.6 degrees Fahrenheit on unspecified date and blood pressure 98/60 mm/Hg and 107 beats / minute on 27 February 2015 at 2:19 PM. The corrective treatment includes Hydrocodone-Acetaminophens 5-325 MG TABS (1 tab every 6 hours) for severe pain and NEURONTIN 100 MG oral CAPS (1-2 caps three times a day for nerve pain).
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unknown number of patients of unknown age and gender. On unknown dates, the patients were inadvertently vaccinated with doses of VAQTA (lots # L014068 exp date 02-NOV-2017 and L018499 exp date 25-FEB-2017) that were improperly stored. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to unspecified number of patients of unknown age and gender. Information about concurrent conditions, medical history and concomitant medication was not provided. On unknown dates the patients were vaccinated with doses of improperly stored RECOMBIVAX HB (lot # was reported as L00559, complete lot number was not provided) and the lot # was an invalid lot # for RECOMBIVAX HB, expiration date 15-APR-2017, dose, dose # and route unknown. No adverse symptoms reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Pneumonia
Clinical narrative: Information has been received from an infectious disease specialist as part of a marketing research program, referring to a patient of unknown age and gender. There was no concurrent condition or medical history reported. On an unknown date, the patient was vaccinated with PNEUMOVAX23 (dosage, strength, route and lot # not reported). There was no concomitant medication reported. On an unknown date, the patient had pneumonia. The outcome of the event was recovered. This is one of several reports received from the same reporter. Additional information is not expected as the reporter did not want to be contacted.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a physician concerning 3 patients of unknown age and gender. The patients' pertinent medical histories or concurrent conditions were not provided. On an unknown dates, the patients were vaccinated with ZOSTAVAX (routes, doses, anatomical locations, lot/batch# were not reported). Co-suspect therapies or concomitant medications were not provided. On an unknown dates, the physician had vaccinated 3 unspecified patients with the vaccine, and all 3 of the patients broke out in shingles. It was unspecified how or when the physician found out that the patients had gotten shingles. The outcome of herpes zoster was unknown. No product quality complaint was involved. The relatedness between the event and suspect therapy was not provided. Additional information has been requested.
Age: 54.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, Inappropriate schedule of drug administration, No therapeutic response, Product quality issue
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of therapy non-responder in a 54-year-old female patient who received ENGERIX B adult (batch number 995J5, expiry date 6th February 2017). This case was associated with a product complaint. Co-suspect products included ENGERIX B adult (batch number F3BB3, expiry date 18th April 2017) and ENGERIX B adult (batch number 24JP3, expiry date 10th JULY 2017. On 8th January 2015, the patient received the 1st dose of ENGERIX B adult (subcutaneous). On 11th MARCH 2015, the patient received the 2nd dose of ENGERIX B adult (subcutaneous). On 8th JULY 2015, the patient received the 3rd dose of ENGERIX B adult (subcutaneous). On 10th SEPTEMBER 2015, 245 days after received ENGERIX B adult, 183 days after receiving ENGERIX B adult and 64 days after receiving ENGERIX B adult, the patient experienced therapy non-responder. On an unknown date, the patient experienced drug dose administration interval too long, drug dose administration interval too short and pharmaceutical product complaint. On an unknown date, the outcome of the therapy non-responder, drug dose administrationinterval too long, drug dose administration interval too short and pharmaceutical product complaint were unknown. The reporter considered the therapy non-responder to be possibly related to ENGERIX B adult. ENGERIX B adult and EXGERIX B adult. Additional details were as follows:The case was one of the several reports reported by an occupational nurse for patients tested negative for Hepatitis B tires following vaccination with ENGERIX B (see cases US2015GSK136757, US2015GSK136758, US2015GSK136759, US2015GSK136760, US2015GSK136761 and US2015GSK136762). The caller reported that they had their laboratory equipment recalibrated and the tests were rerun and results were same or even lower titre's. The patient concerned in this case received 1st dose of ENGERIX B adult on 8th JANURY 2015. On 11th MARCH 2015, the patient received the 2nd dose, which led to lengthening of the vaccination schedule. On 8th JULY 2015, the patient received the 3rd dose, which led to shortening of the vaccination schedule. On 10th SEPTEMBER 2015, 245 days after receiving 1st dose of ENGERIX B adult, 183 days after receiving 2nd dose of ENGERIX B adult and 64 days after receiving 3rd dose of ENGERIX B adult, the patient underwent test for Hepatitis B antibodies and it was found to be negative causing the patient to be non-responder to the therapy.
Age: 49.0
Sex: F
Vaccine: PPV
Symptoms: Headache, Influenza like illness, Pruritus generalised, Pyrexia
Clinical narrative: Information has been received via AbbVie (other company# 15K-163-1476518-00) from a 49 year old female patient referring to herself. There was no medical history reported. On 01-OCT-2015 the patient received one dose of PNEUMOVAX23 (dose, lot# and route were unknown) and the second dose of HUMIRA 40 mg solution for injection (once in 2 weeks). No concomitant therapy was reported. On 02-OCT-2015, the patient experienced Flu-like symptoms (fever, headache) as well as itching all over. She was treated with BENADRYL. Therapy with HUMIRA was continued. The outcome of the events was unknown. The reporter did not know the lot number of the drugs and she considered that there was a reasonable possibility that the events were probably related to HUMIRA. Causality assessment for PNEUMOVAX23 was not provided. Additional information is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed vocational nurse refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 22-OCT-2015, the patient was vaccinated with a dose of VARIVAX (Merck), lot # L006383 and expiration date 25-MAR-2017 (dose, route of administration and anatomical location were not provided). There were no concomitant medications reported. No adverse effect was reported. No product quality issue was involved. This is one of several cases from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product preparation error
Clinical narrative: This spontaneous report was received from a pharmacist concerning a patient of unknown age and gender. No concurrent conditions or medical history were reported. On 10-NOV-2015, the patient was vaccinated with a dose of ZOSTAVAX (dose, lot No., route and anatomical location of administration were not reported). No concomitant therapy was provided. The pharmacist reported that the ZOSTAVAX was reconstituted with normal saline, instead of the intended sterile water. No adverse effects were reported and no Product Quality Complaint (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse referring to unspecified patients of unknown age and gender. There was no concurrent condition or medical history reported. On unspecified dates the unspecified patients were vaccinated with doses of improperly stored oral, ROTATEQ (lot # L001316, expiration date 10-NOV-2016) (dosage, strength and route were not reported). There was no concomitant medication reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse referring to unspecified patients of unknown age and gender. There was no concurrent condition or medical history reported. On unspecified dates the unspecified patients was vaccinated with doses of improperly stored VAQTA (lot # L018499, expiration date 25-FEB-2017) (dosage, strength and route were not reported). There was no concomitant medication reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to unspecified number of patients of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and medications were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL (dose and route were not reported, lot # K007828 with expiration date: 02-MAR-2017). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unknown number of patients of unknown age and gender. On unknown dates, the patients were inadvertently vaccinated with doses of oral, ROTATEQ (lots # reported as L010859 exp date 19-JAN-2017, L004456 exp date 07-AUG-2016, K019370 exp date 16-JUL-2016 and L008054 exp date 30-NOV-2016) (Lot # L010859 is an invalid lot for oral) (route not reported) that were improperly stored. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unknown number of patients of unknown age and gender. On unknown dates, the patients were inadvertently vaccinated with doses of PNEUMOVAX 23 (lots # L008664 exp date 03-NOV-2016 and L003188 exp date 06-JUN-2016) (route not reported) that were improperly stored. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare professional, refers to an unknown number of patients of unknown age and gender. The patient's medical history and concurrent conditions were not reported. The healthcare professional informed that on an unknown date, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # L013429, expiration date: 21-JUL-2017, (dosage and route were not provided). Concomitant therapy was not reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unknown number of patients of unknown age and gender. On unknown dates, the patients were inadvertently vaccinated with GARDASIL (lots # reported as K008931 exp date 04-MAR-2017, K010215 exp date 05-MAY-2017 and L033347 exp date 23-JUL-2017) (route not reported) that were improperly stored. No adverse effects were reported. This is one of several reports received from the same source. 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 medical assistant refers to an unknown number of patients of unknown age and gender. On unknown dates, the patients were inadvertently vaccinated with doses of M-M-R II (lots # L000458 exp date 06-JAN-2017, L012480 exp date 10-APR-2017 and L010488 exp date 26-MAR-2017) (route not reported) that were improperly stored. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to unspecified number of patients of unknown age and gender. The patients' pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ (dose not reported, orally, lot # L000571 with expiration date: 26-JUL-2017, lot # L008578 with expiration date: 14-DEC-2016). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to unspecified patients of unknown age and gender. No concurrent conditions, medical history or concomitant medications were reported. On an unknown date, the unspecified patients were vaccinated with GARDASIL lot# K006960, expiration date 19-FEB-2017 and lot# J008423, expiration ate 21-JAN-2016 (total of 14 doses-number of each Lot # administered were not specified) (dose, strength, administration route were not reported), that had been improperly stored. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare professional, refers to an unknown number of patients of unknown age and gender. The patient's medical history and concurrent conditions were not reported. The healthcare professional informed that on an unknown date, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB, lot # J014855 expiration date: 16-APR-2016 and lot # L016959, expiration date: 12-MAR-2018 (dosage and route were not provided). Concomitant therapy was not reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a register nurse, refers to an unspecified number of patients, of unknown age and gender. The patients' medical history and concurrent conditions were not reported. The register nurse informed that on an unknown date, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # K026246, expiration date: 28-JAN-2017; lot # L016429, expiration date: 09-AUG-2017; lot # L025737, expiration date: 28-JUL-2017; lot # L014415, expiration date: 25-JUL-2017 (strength, dosage and route were not reported). Concomitant therapy was not reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: This spontaneous report was received from a physician via a company representative reporting on unknown number of patients of unknown age and gender. Patient's pertinent medical history and concurrent conditions were not reported. On an unknown date, the patients were vaccinated with a dose of PNEUMOVAX23 (lot number, expiration date strength, dose and route were not provided). Concomitant medication was not reported. The physician reported that the facility, where he sited on at the unspecified facility where he had a surgery and was vaccinated with PNEUMOVAX23 (captured in MARRS#1511USA010027), had encountered, on an unspecified date, other patients with his same experience of pyrexia reported as "fever". The outcome of pyrexia was unknown at the time of the report. The reporter did not assess the relatedness of PNEUMOVAX23 to pyrexia. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist, refers to a patient of unknown age and gender. The patients medical history and concurrent conditions were not reported. On 09-NOV-2015, the patient was vaccinated with ZOSTAVAX 0.65 ml, subcutaneous, (lot# and expiration date were not reported). Concomitant therapy was not reported. The physician informed that after this dose was administered he/she found out that the patient possibly received a previous dose of ZOSTAVAX in July 2013 (dose, route and lot number unspecified). No symptoms reported. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: This spontaneous report was received from a male physician between 65 and 67 years old via a company representative reporting on himself. The patient had received PREVNAR 13 in approximately 2014 reported as "the last year prior to the knee surgery and the PNEUMOVAX 23". The patient stated that he was in hospitalization on an unspecified facility for knee replacement surgery this past summer 2015. While still an inpatient, on an unspecified date in 2015, the facility administered to the patient a dose of PNEUMOVAX 23 (lot number, expiration date strength, dose and route were not provided). Concomitant medication was not reported. About 24 hours after receiving the PNEUMOVAX 23, the patient experienced pyrexia reported as "a fever". The patient was concerned as he feared an infection resulting from the surgery. But, there was no infection from the knee surgery. The outcome of pyrexia was unknown at the time of the report. The reporter did not assess the relatedness of PNEUMOVAX 23 to pyrexia. This is one of several reports from the same source. 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 register nurse, refers to an unspecified number of patients, of unknown age and gender. The patient's medical history and concurrent conditions were not reported. The register nurse informed that on an unknown date, the patients were vaccinated with improperly stored doses of M-M-R II, (lot # L003859, expiration date: 05-FEB-2017; (strength, dosage and route were not reported). Concomitant therapy was not reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker reporting a patient of unknown age and gender. On an unknown date, the patient was vaccinated by an unspecified nurse with an improperly stored M-M-R II lot # J016232, exp. 19/12/2015. Route, anatomical place and dose number were not provided. Concomitant therapies were not provided. At the time of the report, no adverse event was reported. The outcome was reported as unknown. Additional information is expected.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a register nurse, refers to an unspecified number of patients, of unknown age and gender. The patient's medical history and concurrent conditions were not reported. The register nurse informed that on an unknown date, the patients were vaccinated with improperly stored doses of VAQTA lot # K015827, expiration date: 11-MAR-2017; lot # L002717, expiration date: 02-JUN-2017; lot # L023936, expiration date: 15-MAR-2017 (strength, dosage and route were not reported). Concomitant therapy was not reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report has been received from a pharmacist concerning an unspecified number of patients of unknown age and gender. The patients' concurrent conditions and pertinent medical history were not reported. On an unknown date, the patients were vaccinated with doses of PNEUMOVAX23, (lot #, exp. date, strength, route of administration and dose were not provided). There was no concomitant medication reported. On an unknown date, the patients experienced "redness and swelling" at the injection site while using PNEUMOVAX23. The pharmacists reported that a number of patients sought medical attention the day following the vaccination. Additionally, she stated that the adverse experience improved within a few days following the injection. Therefore, the patients status was reported as recovered. The causal assessment of redness and swelling at the injection site to PNEUMOVAX23 was not reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a register nurse, refers to an unspecified number of patients, of unknown age and gender. The patient's medical history and concurrent conditions were not reported. The register nurse information that on an unknown date, the patients were vaccinated with improperly stored doses of ROTATEQ orally, lot # K022995, expiration date: 22-JUL-2016; lot # K011947, expiration date: 07-JUN-2016. (Strength and dosage were not reported). Concomitant therapy was not reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed vocational nurse refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 21-OCT-2015, the patient was vaccinated with a dose of VARIVAX, lot # L006383 and expiration date 25-MAR-2017 (dose, route of administration and anatomical location were not provided). There were no concomitant medications reported. No adverse effect was reported. No product quality issue was involved. This is one of several cases from the same reporter. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site inflammation, Injection site nodule, Injection site pain
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 64 year old female patient. The patient had no pertinent medical history and there were no drug allergies/drug reactions reported. The patient reported that she was vaccinated with an unspecified flu vaccine on an unspecified date in September 2015. On 13-NOV-2015, the patient was vaccinated with ZOSTAVAX (lot number, expiration date, dose, route of administration and anatomical location were not reported). There was no concomitant medication reported. On 14-NOV-2015, the patient experienced injection site nodule which was red and sore and injection site inflammation. No treatment was given to treat the injection site nodule and inflammation. Additionally, it was reported that on an unspecified date in November 2015, the patient called to the pharmacist for medical attention. At the reporting time, the outcome of injection site nodule and injection site inflammation was reported as not recovered/not resolved. 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 medical assistant refers to an unspecified number of unspecified patients. On an unspecified date in 2015, the patients were vaccinated with improperly stored dose of MMR II (lot# K024038, expiration date 26-NOV-2016, albumin status rHA; L012479, expiration date 10-APR-2017, albumin status rHA). No adverse effects have been reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician concerning a patient (age, gender, medical history and concomitant medication use not specified). The physician reported that on 13-JAN-2015 the patient was vaccinated with PEDVAXHIB (lot # J000564, expiration date 02NOV2015), .5 ml, intramuscularly, that had been improperly stored. No adverse event was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to unspecified patients of unknown age and gender. There was no concurrent condition or medical history reported. On unspecified dates in August 2015 unspecified patients were vaccinated with 4 doses of improperly stored (Oka-Merck) PROQUAD HSA (human serum albumin) (lot # K018144, expiration date 10-APR-2016) (dosage, strength and route were not reported). There was no concomitant medication reported. No adverse symptoms was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a physician via company representative, refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. The physician informed that on an unknown date in 2014, (reported as "some time last year, 2014"), the patient was vaccinated with the first dose of GARDASIL (dosage, route, lot# and expiration date were not reported). Subsequently in2 015 (reported as "one year later"), the patient received the second dose of GARDASIL (dosage, route, lot# and expiration date were not reported) and then two months later, in 2015, received the third dose of GARDASIL (dosage, route, lot# and expiration date were not reported). No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a other health professional refers to unspecified patients of unknown age and gender. The patients concurrent conditions and medical history were not provided. On an unknown date in October 2015, the patients were vaccinated with (Oka-Merck) PROQUAD two doses of (lot # K012918, expiration date 28-FEB-2016), two doses of (lot # L032759, expiration date 24-FEB-2017) and one dose of (lot # K012918, expiration date 28-FEB-2016) that was improperly stored. No adverse effects were reported. This is one of 2 reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: FLU3, PPV
Symptoms: Erythema, Headache, Injection site nodule, Nausea, Pain
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a currently 56 year old patient of unknown gender. The patient's concurrent condition, medical history or concomitant medications were not reported. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX23, injection, lot # L003188, expiration date 06-JUL-2016 in the arm (dose and route of administration were not reported). On the same day, the patient received FLUZONE (dose, lot #, expiration date and route of administration were not reported). On an unknown date, the patient experienced nausea, a headache, "terribly achy body" and fever. It was also reported that each of the patient's arms were red and she/he had a knot the size of a baseball at the injection site after being vaccinated with PNEUMOVAX23 and FLUZONE was not reported. The patient sought unspecified medical attention on an unknown date. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: FLU3, PPV
Symptoms: Pyrexia
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a currently 56 year old patient of unknown gender. The patient's concurrent condition, medical history or concomitant medications were not reported. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX23, injection, lot # L003188, expiration date 06-JUL-2016 in the arm (dose and route of administration were not reported). On the same day, the patient received FLUZONE (dose, lot #, expiration date and route of administration were not reported). On an unknown date, the patient experienced nausea, a headache, "terribly achy body" and fever. It was also reported that each of the patient's arms were red and she/he had a knot the size of a baseball at the injection site after being vaccinated with PNEUMOVAX23 and FLUZONE was not reported. The patient sought unspecified medical attention on an unknown date. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to unspecified patients of unknown demographics. Information regarding medical history, concurrent conditions and drug reactions/allergies were not reported. On an unknown date, the patients received improperly stored RECOMBIVAX HB (Lot # K021581, expiry date: 24-OCT-2016; lot # K0265531, expiry date: 15-APR-2017 and lot # L0119299, expiry date: 15-APR-2017). No adverse effects were reported. This is one of the three reports received from the same reporter. Additional information has been requested.
Age: 91.0
Sex: M
Vaccine: VARZOS
Symptoms: Burning sensation, Foreign body sensation in eyes, Injection site pruritus, Injection site rash, Pain
Clinical narrative: This initial spontaneous report was received from a 91 year old male consumer who was also a retired physician reporting on himself. There was no pertinent medical history, concurrent conditions, or drug allergies/drug reactions described. In approximately 2013 reported as "approximately two years ago", the patient was vaccinated with ZOSTAVAX injection (in the buttock; dose, route, lot# and expiration date were not provided). There was no concomitant medication described. In approximately 2013 reported as "one to two months later", the patient experienced itching at the injection site (on an unspecified buttock). He presented a rash (injection site rash) approximately one and one half inches long; this rash persisted for approximately one year; the rash began regressing but then on an unknown date an ulceration (ulcer) approximately 3 centimeters in length appeared. That was treated (with unspecified antibiotic cream) and healed on an unspecified date. The patient stated that currently there was a bilateral feeling of "sunburn" on both buttocks; he had no pain as long as he was standing, but when seated there was an uncomfortable feeling as if the area was "sunburned" (burning sensation). The patient was also currently unable to sleep on his back due to the painful sensation (musculoskeletal pain). There was no clinical sign of redness on the buttocks, and the skin appeared like "normal tissue". The pain in the buttocks had lessened over time, but had not abated. The patient also reported a sensation of "feeling an eyelash" on his inner eyelid of an unspecified eye (ocular discomfort), but an unspecified ophthalmologist could find nothing that would caused this sensation. The patient sought medical attention (went to the physician). Product quality complaint (PQC) was not involved. At the time of the report, the outcome of injection site rash and ulcer was recovered. The outcome of burning sensation was reported as not recovered, musculoskeletal pain was recovering and the outcome of ocular discomfort was unknown. Additional information is not expected as there is no consent to follow-up.
Age: 91.0
Sex: M
Vaccine: VARZOS
Symptoms: Sleep disorder, Ulcer
Clinical narrative: This initial spontaneous report was received from a 91 year old male consumer who was also a retired physician reporting on himself. There was no pertinent medical history, concurrent conditions, or drug allergies/drug reactions described. In approximately 2013 reported as "approximately two years ago", the patient was vaccinated with ZOSTAVAX injection (in the buttock; dose, route, lot# and expiration date were not provided). There was no concomitant medication described. In approximately 2013 reported as "one to two months later", the patient experienced itching at the injection site (on an unspecified buttock). He presented a rash (injection site rash) approximately one and one half inches long; this rash persisted for approximately one year; the rash began regressing but then on an unknown date an ulceration (ulcer) approximately 3 centimeters in length appeared. That was treated (with unspecified antibiotic cream) and healed on an unspecified date. The patient stated that currently there was a bilateral feeling of "sunburn" on both buttocks; he had no pain as long as he was standing, but when seated there was an uncomfortable feeling as if the area was "sunburned" (burning sensation). The patient was also currently unable to sleep on his back due to the painful sensation (musculoskeletal pain). There was no clinical sign of redness on the buttocks, and the skin appeared like "normal tissue". The pain in the buttocks had lessened over time, but had not abated. The patient also reported a sensation of "feeling an eyelash" on his inner eyelid of an unspecified eye (ocular discomfort), but an unspecified ophthalmologist could find nothing that would caused this sensation. The patient sought medical attention (went to the physician). Product quality complaint (PQC) was not involved. At the time of the report, the outcome of injection site rash and ulcer was recovered. The outcome of burning sensation was reported as not recovered, musculoskeletal pain was recovering and the outcome of ocular discomfort was unknown. Additional information is not expected as there is no consent to follow-up.