chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: HPV9
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 638773). This spontaneous report refers to a 22 year old female patient. Patient had no concurrent illnesses and medical history. Patient's other medications included sprintec, bactrim DS and ibuprofen. On 10-JUN-2016, the patient was vaccinated with GARDASIL 9 lot # M007728, dose 1, intramuscularly in the right arm for prophylaxis. On 10-JUN-2016, reaction started as rash/itching on thighs, spread to legs and ankles. By next day it developed on arms, hands and lumbar area. Patient took benadryl, claritin and used diphenhydramine cream. By 14:00 the next day, the rash kept spreading and the itch was intolerable. Which had appeared to be petechiae/purpura now looked more like hives on ankles and lower legs. Patient went to an urgent care and was given a steroid shot and was prescribed hydrocortisone 1 % ointment. The outcome of the events was reported as unknown. The causality assessment for all the events with respect to GARDASIL 9 was not provided by the reporter. Additional information is not expected from the agency as follow up information cannot be obtained.
Sex: F
Vaccine: HEPA, HPV9
Symptoms: Hypersensitivity, Rash
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 638916) on 18-APR-2017. This spontaneous report as received from a regulatory authority refers to a 13 year old female patient. The patient's concurrent illnesses and medical history were reported as none. Other medications included OCP/Acid Reflux. On 02-JUN-2016 at 3 PM, the patient was vaccinated with the first dose of GARDASIL 9 lot # L013429, intramuscularly in the right arm for prophylaxis and the patient travelled to grandmother's house overnight. Other suspect therapies included HAVRIX. On 03-JUN-2016, the patient got up with rash bumps and her mother took to emergency room and doctor stated that patient had allergic reaction. On same day the patient's prior vaccinations included Hepatitis A (no brand name) 29.00 Sibling. The outcome of hypersensitivity and rash was unknown. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Rash
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 638976) on 18-APR-2017. This spontaneous report as received from a regulatory authority refers to a 11 year old female patient. The patient had no concurrent illnesses. The patient's medical history included sulfa allergy. Information on the patient's prior vaccinations and other medications were not reported. On 23-MAY-2016 the patient was vaccinated with the second dose of GARDASIL 9 lot # M003659, intramuscularly in the right arm (dose, frequency and lot expiration date were not reported) for prophylaxis. On an unknown date the patient experienced rash on arms and legs. The outcome of rash was reported as recovered/resolved. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 23.0
Sex: F
Vaccine: HEPA, HPV9, MENB, MNQ, VARCEL
Symptoms: Dizziness, Injection site pain, Nausea
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 639012) on 18-APR-2017. This spontaneous report as received from a regulatory authority refers to a 23 year old female patient. The patient had no concurrent illnesses and medical history. Information on the patient's prior vaccinations and other medications were not reported. On 24-MAY-2016 the patient was vaccinated with GARDASIL 9 lot # L045711, dose 1, intramuscularly in the left arm; VARIVAX, lot #  L040419, dose 1, Subcutaneous in the left arm and hepatitis a vaccine, inactivated (VAQTA), lot # L036449, dose 1, intramuscularly in the right arm for prophylaxis. Other suspect therapies included MENACTRA and BEXSERO. On 25-MAY-2016 the patient had significant soreness (L) in deltoid area and no redness or swelling. The patient experienced nauseated and lightheaded. The outcome of dizziness, nausea and injection site pain was reported as recovered/resolved after 3-4 days. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 19.0
Sex: F
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS ID-639232). This spontaneous report refers to a 19 year old female patient. The patient's historical conditions included anxiety. The patient's current illness, other medications and prior vaccinations were not reported. On 27-MAY-2016 the patient was vaccinated with GARDASIL 9 lot # M003659 dose 3 (unspecified dose and frequency), intramuscularly in unknown site for prophylaxis. 10 minutes after vaccination, the patient fainted. The patient was made to lay down for 30 min and was given cold soda. The outcome of syncope was reported as recovered. Causality assessment was not provided. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Condition aggravated, Headache, Hypoaesthesia, Migraine
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 640277). This spontaneous report refers to a 12 year old female patient. Patient had no concurrent illnesses and other medications. The patient's medical history included headache and seasonal allergies. On 17-NOV-2015, the patient was vaccinated with GARDASIL 9 lot # L019286, dose 2, intramuscularly in the left arm for prophylaxis. When patient arrived for 3rd dose of GARDASIL her mom asked if it was normal as the patient had a migraine (already had history of occasional migraines) with numbness on hands/arms (lasted for hours) on 17-NOV-2015 (the day of GARDASIL 9 dose 2 vaccine). Patient had increased frequency of migraines. Numbness resolved but sill had headache. The outcome of the event migraine was reported as not recovered. The causality assessment for all the events with respect to GARDASIL 9 was not provided by the reporter. Additional information is not expected from the agency as follow up information cannot be obtained.
Sex: F
Vaccine: FLUN4, HPV9
Symptoms: Dizziness, Headache, Visual impairment
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS ID-640637). This spontaneous report refers to a 11 year old female patient. The patient had no known allergies. The patient had negative history for standard immunization screening questions. The patient had no current illness, prior vaccinations and other medications. On 17-NOV-2015 the patient was vaccinated with GARDASIL 9 lot # L007560 (unspecified dose and frequency), intramuscularly for prophylaxis. On the same day, the patient was vaccinated with FLUMIST (unspecified dosage regimen), through nasal route for prophylaxis. After 2 days, on 19-NOV-2015, the patient had headache. A week later, upon arising saw black spots, dizzy, could not see well (visual impairment). The patient was made to lay down and symptoms resolved in one minute. Emergency room staff were called and asked to wait to see if symptoms recurred and checked in with doctor's office. The patient had headache's daily but lasted only for about 5 minutes. The outcome of visual impairment, headache and dizziness was unknown. Causality assessment was not provided. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 25.0
Sex: F
Vaccine: HPV9
Symptoms: Feeling abnormal, Pain in jaw
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA, under the Freedom of Information Act. Case narrative Jaw pain. She felt out of it that day GARDASIL 9 was given. 02-OCT-2016 woke up with jaw pain (L) side that radiates. Lab data None Other Medications Current Illnesses None History No Prior Vaccinations. Additional information is not expected because no follow up can be obtained from the Agency.
Age: 38.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Asthenia, Back pain, Balance disorder, Blood test, Muscular weakness
Clinical narrative: Initial unsolicited report received from other medical assistant health care professional on 23 Feb 2017. This case involves a 38-year-old male patient who was vaccinated with first dose of ADACEL (Batch number: U5533AA, expiration date, dose and route was not reported) in the left deltoid on 02 Feb 2017 I.M. Any other vaccinations within four weeks of vaccinations and Illness at time of vaccination were reported as none. The patient had a medical history of traumatic brain injury with physical and speech deficits many years ago. On 06 Feb 2017, pt states next day, four days following the vaccination, the patient had experienced bilateral arm soreness across shoulders and down back, leg weakness, generalized weakness, bilateral tinnitus which is getting worse daily, balance issues and difficulty with speech. It was reported that, the patient has been seen in the office many times and referred to a neurologist. Pt did not report until 3 days later. Patient required emergency visit at Dr. office not ER. Lab data includes blood work and urine (negative) and spinal tap (refused). It was reported that all exams found no change physically from the patient's baseline. Corrective treatment was not reported. The patient was not recovered from the events. List of documents held by sender: none.
Age: 38.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Musculoskeletal pain, Pain in extremity, Speech disorder, Tinnitus, Urine analysis normal
Clinical narrative: Initial unsolicited report received from other medical assistant health care professional on 23 Feb 2017. This case involves a 38-year-old male patient who was vaccinated with first dose of ADACEL (Batch number: U5533AA, expiration date, dose and route was not reported) in the left deltoid on 02 Feb 2017 I.M. Any other vaccinations within four weeks of vaccinations and Illness at time of vaccination were reported as none. The patient had a medical history of traumatic brain injury with physical and speech deficits many years ago. On 06 Feb 2017, pt states next day, four days following the vaccination, the patient had experienced bilateral arm soreness across shoulders and down back, leg weakness, generalized weakness, bilateral tinnitus which is getting worse daily, balance issues and difficulty with speech. It was reported that, the patient has been seen in the office many times and referred to a neurologist. Pt did not report until 3 days later. Patient required emergency visit at Dr. office not ER. Lab data includes blood work and urine (negative) and spinal tap (refused). It was reported that all exams found no change physically from the patient's baseline. Corrective treatment was not reported. The patient was not recovered from the events. List of documents held by sender: none.
Age: 38.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Asthenia, Back pain, Balance disorder, Blood test normal, Injection site pain
Clinical narrative: Initial unsolicited report received from other medical assistant health care professional on 23 Feb 2017. This case involves a 38-year-old male patient who was vaccinated with first dose of ADACEL (Batch number: U5533AA, expiration date, dose and route was not reported) in the left deltoid on 02 Feb 2017 I.M. Any other vaccinations within four weeks of vaccinations and Illness at time of vaccination were reported as none. The patient had a medical history of traumatic brain injury with physical and speech deficits many years ago. On 06 Feb 2017, pt states next day, four days following the vaccination, the patient had experienced bilateral arm soreness across shoulders and down back, leg weakness, generalized weakness, bilateral tinnitus which is getting worse daily, balance issues and difficulty with speech. It was reported that, the patient has been seen in the office many times and referred to a neurologist. Pt did not report until 3 days later. Patient required emergency visit at Dr. office not ER. Lab data includes blood work and urine (negative) and spinal tap (refused). It was reported that all exams found no change physically from the patient's baseline. Corrective treatment was not reported. The patient was not recovered from the events. List of documents held by sender: none.
Age: 38.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Muscular weakness, Musculoskeletal pain, Pain in extremity, Speech disorder, Tinnitus
Clinical narrative: Initial unsolicited report received from other medical assistant health care professional on 23 Feb 2017. This case involves a 38-year-old male patient who was vaccinated with first dose of ADACEL (Batch number: U5533AA, expiration date, dose and route was not reported) in the left deltoid on 02 Feb 2017 I.M. Any other vaccinations within four weeks of vaccinations and Illness at time of vaccination were reported as none. The patient had a medical history of traumatic brain injury with physical and speech deficits many years ago. On 06 Feb 2017, pt states next day, four days following the vaccination, the patient had experienced bilateral arm soreness across shoulders and down back, leg weakness, generalized weakness, bilateral tinnitus which is getting worse daily, balance issues and difficulty with speech. It was reported that, the patient has been seen in the office many times and referred to a neurologist. Pt did not report until 3 days later. Patient required emergency visit at Dr. office not ER. Lab data includes blood work and urine (negative) and spinal tap (refused). It was reported that all exams found no change physically from the patient's baseline. Corrective treatment was not reported. The patient was not recovered from the events. List of documents held by sender: none.
Age: 38.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Urine analysis normal
Clinical narrative: Initial unsolicited report received from other medical assistant health care professional on 23 Feb 2017. This case involves a 38-year-old male patient who was vaccinated with first dose of ADACEL (Batch number: U5533AA, expiration date, dose and route was not reported) in the left deltoid on 02 Feb 2017 I.M. Any other vaccinations within four weeks of vaccinations and Illness at time of vaccination were reported as none. The patient had a medical history of traumatic brain injury with physical and speech deficits many years ago. On 06 Feb 2017, pt states next day, four days following the vaccination, the patient had experienced bilateral arm soreness across shoulders and down back, leg weakness, generalized weakness, bilateral tinnitus which is getting worse daily, balance issues and difficulty with speech. It was reported that, the patient has been seen in the office many times and referred to a neurologist. Pt did not report until 3 days later. Patient required emergency visit at Dr. office not ER. Lab data includes blood work and urine (negative) and spinal tap (refused). It was reported that all exams found no change physically from the patient's baseline. Corrective treatment was not reported. The patient was not recovered from the events. List of documents held by sender: none.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL, DTAPIPV, MMR, VARCEL
Symptoms: Haematuria, Henoch-Schonlein purpura nephritis, Purpura, Urinary tract infection
Clinical narrative: According to parent purple bumps (purpura) appeared on child's shins starting day after immunizations MMR, Dtap, and varicella. Symptoms resolving on 18 Jan. Noted UTI then hematuria 22 Feb. 13 Mar noted purpuric nephritis.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL, DTAPIPV, MMR, VARCEL
Symptoms: Abdominal pain, Blood albumin decreased, Blood creatine decreased, Blood urine present, Decreased appetite
Clinical narrative: According to parent purple bumps (purpura) appeared on child's shins starting day after immunizations MMR, Dtap, and varicella. Symptoms resolving on 18 Jan. Noted UTI then hematuria 22 Feb. 13 Mar noted purpuric nephritis.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL, DTAPIPV, MMR, VARCEL
Symptoms: Epistaxis, Glomerular filtration rate normal, Haematuria, Henoch-Schonlein purpura, Henoch-Schonlein purpura nephritis
Clinical narrative: According to parent purple bumps (purpura) appeared on child's shins starting day after immunizations MMR, Dtap, and varicella. Symptoms resolving on 18 Jan. Noted UTI then hematuria 22 Feb. 13 Mar noted purpuric nephritis.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL, DTAPIPV, MMR, VARCEL
Symptoms: Protein total decreased, Protein urine present, Proteinuria, Pyrexia, Red blood cells urine positive
Clinical narrative: According to parent purple bumps (purpura) appeared on child's shins starting day after immunizations MMR, Dtap, and varicella. Symptoms resolving on 18 Jan. Noted UTI then hematuria 22 Feb. 13 Mar noted purpuric nephritis.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL, DTAPIPV, MMR, VARCEL
Symptoms: Skin discolouration, Urinary casts, Urinary sediment abnormal, Urinary tract infection, Urine analysis abnormal
Clinical narrative: According to parent purple bumps (purpura) appeared on child's shins starting day after immunizations MMR, Dtap, and varicella. Symptoms resolving on 18 Jan. Noted UTI then hematuria 22 Feb. 13 Mar noted purpuric nephritis.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL, DTAPIPV, MMR, VARCEL
Symptoms: Urine protein/creatinine ratio increased, Vomiting, White blood cells urine positive
Clinical narrative: According to parent purple bumps (purpura) appeared on child's shins starting day after immunizations MMR, Dtap, and varicella. Symptoms resolving on 18 Jan. Noted UTI then hematuria 22 Feb. 13 Mar noted purpuric nephritis.
Age: 23.0
Sex: M
Vaccine: ANTH, JEV
Symptoms: Injection site reaction, Rash papular
Clinical narrative: Appears to be spreading down the arm. Raised red rash on front and back, right, shoulder.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Selective eating disorder, Vomiting projectile
Clinical narrative: Projectile vomited while breastfeeding.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's drug reactions or allergies, medical history and concomitant medications were not reported. On 17-MAR-2017, the patient might have been inadvertently vaccinated with an unknown dose of VARIVAX (lot # M025870, 24-MAY-2019; route was not reported) reconstituted with sterile diluent instead of PROQUAD. No adverse effects were reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative refers to a female patient of unknown age. The patient's drug reactions or allergies, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with an unknown dose of ZOSTAVAX (route, lot # and expiry date were not reported). On an unknown date, after receiving ZOSTAVAX, the patient experienced shingles. The outcome of the event was unknown. The relatedness between the event and ZOSTAVAX was not reported. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, MMRV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 12-month-old female patient. The patient had no relevant medical history, drug history or laboratory test results. On 12-APR-2017, the patient was vaccinated with PROQUAD rHA, 0.5milliliter (ml) in a single dose, intramuscularly (lot#M026879, expiration date: 27-NOV-2017) (anatomical location was not reported) for prophylaxis. On the same date, the patient was vaccinated with M-M-R II rHA, (lot# M008588, expiration date: 16-FEB-2018) (dose, route of administration and anatomical location were not provided) for prophylaxis. On 12-APR-2017, a sterile diluent (manufacturer unknown) solution for injection (lot# reported as M04921 identified to be not valid and M014921, expiration date: 30-NOV-2018) (dose and anatomical location were not provided) was used to dilute both of the aforementioned vaccines and administered together with the respective vaccines. Concomitant therapies included hepatitis A virus vaccine (unspecified) (GlaxoSmithKline) administered on 12-APR-2017 and fluticasone nasal spray. On 12-APR-2017, the patient was given PROQUAD as an intramuscular injection, however the reporter stated that she should have VARIVAX. When this immunization occurred the patient was also given M-M-R II and hepatitis A virus vaccine (unspecified) (GlaxoSmithKline). No issues or adverse events were reported. At the time of the report, it was unknown whether PROQUAD or M-M-R II will be administered in the future. The outcome of accidentally administering PROQUAD was unknown. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Injection site reaction, Rash
Clinical narrative: This spontaneous report was received from a nurse via a field representative and refers to a 51 year old female patient. The patient's concurrent conditions included allergy to sulfonamide and codeine. The patient's medical history included diverticulosis and chlamydia. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX, subcutaneously (exact dose, lot# and expiry date were not reported) for prevention of shingles. Concomitant therapies included simvastatin (ZOCOR), unspecified fenofibrates, HCPV tablets (unspecified), cetirizine hydrochloride (ZYRTEC), venlafaxine hydrochloride (EFFEXOR XR), fluticasone propionate (FLONASE), sitagliptin phosphate (+) metformin hydrochloride(JANUMET), meloxicam (manufacturer unknown) and tiotropium bromide (SPIRIVA). On an unknown date, the patient had a breakout occurrence of herpes zoster after getting vaccinated with ZOSTAVAX). She also developed a site reaction (onset date unknown) and sought medical attention and was seen by the nurse for a routine check up. During appointment, the nurse witnessed the site reaction and rash on the patient's right arm and treated it with antibiotics (ABX) treatment (unspecified). The patient also experienced pain to reaction area and burning around the injection site. On 13-APR-2017, the patient went to another appointment with the nurse and her side effects had progressed to full blown shingles and her rash had spread to elbows and up to interior sides of upper arms. It was unknown if the patient had received any treatment after the second appointment with a nurse. The outcome of the events was unknown. The relatedness between the events and ZOSTAVAX was not reported. 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, medical history, any known allergies or reactions or concomitant medications.   On an unknown date, the patients were vaccinated with improperly stored ROTATEQ lot # M038847 with expiration date of 27-APR-2018, for prophylaxis (dose and route of administration were not reported). Administered doses of vaccines experienced the temperature excursion of 47.5-77 degrees Fahrenheit (°F)  for 1 hour. Data logger was involved. There were not previous excursions.  No adverse symptoms were reported. No further information was provided. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, medical history, any known allergies or reactions or concomitant medications.  On an unknown date, the patients were vaccinated with improperly stored RECOMBIVAX HB lot # M035487 with expiration date of 23-FEB-2019, for prophylaxis (dose and route of administration were not reported). Administered doses of vaccines experienced the temperature excursion of 55 degrees Fahrenheit (°F) for 30 minutes. Data logger was involved. There were not previous excursions.  No adverse symptoms were reported. No further information was provided. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA012703:
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from  a medical assistant refers to unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, medical history, any known allergies or reactions or concomitant medications.   On an unknown date, the patients were vaccinated with improperly stored ROTATEQ lot # M040271 with expiration date of 30-APR-2018, for prophylaxis (dose and route of administration were not reported). Administered doses of vaccines experienced the temperature excursion of 55 degrees Fahrenheit (°F) for 30 minutes. Data logger was involved. There were not previous excursions.  No adverse symptoms were reported. No further information was provided. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA012690:
Sex: U
Vaccine: VARZOS
Symptoms: Contraindication to vaccination, No adverse event
Clinical narrative: This spontaneous report has been received from a pharmacist and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history and drug reactions or allergies was provided. n an unknown date, the patient was vaccinated with a dose of ZOSTAVAX injection (dose, lot number, expiration date and route of administration were not reported), which was reconstituted with sterile water diluent. The patient was on immunosuppressive therapy with tacrolimus and everolimus at the time of vaccination. No adverse effects were reported. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse, concerning a patient of an unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On an unspecified day in approximately January 2016 (reported as "15 months ago"), the patient was vaccinated with her first dose GARDASIL 9 (lot #, expiration date, strength, dose and anatomical location were not reported), administered intramuscularly for prophylaxis. On 27-APR-2017 (reported as "today"), the patient presented to receive her second dose of GARDASIL 9. No adverse effect was reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician and refers to an unspecified number of patients of unknown demographics. The patients' medical history, concomitant medications ant concurrent conditions were not reported. On unknown dates, the unspecified number of improperly stored doses of ZOSTAVAX (dose, route of administration, anatomical location, lot# and expiration date were not reported) were administered to the patients. No adverse effects have been reported. On unknown dates, the doses were stored in the temperatures between 15 degrees Fahrenheit and 46 degrees Fahrenheit for 336 hours. Information about previous temperature excursion was not provided. Digital data logger and product quality complaint were not involved. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
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 concurrent conditions, medical history, any known allergies, reactions or concomitant medications. On an unknown date, the patient was inadvertently administered a dose of ZOSTAVAX, for prophylaxis (dose, route of administration, lot number and expiration date were not reported) diluted in sterile diluent (DILUENT MRK) injection (dose, lot number and expiration date were not reported) instead of an intended dose of VARIVAX. The pharmacist reported the error occurred because both vaccines were varicella vaccine and it was believed that they were interchangeable. No dose of VARIVAX was administered. No adverse effect was reported. No additional information provided. No product quality complaint. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain
Clinical narrative: This spontaneous report as received from a 64-year-old female patient refers to herself. The patient had allergy to codeine and gabapentin. She had no pertinent medical history. On an unknown date in October 2007, the patient was vaccinated with ZOSTAVAX (dose, route of administration, lot# and expiration date were not provided), to prevent shingles. Concomitant therapies included acetaminophen (manufacturer unknown), aspirin (+) citric acid (+) sodium bicarbonate (ALKA-SELTZER), and unspecified Bayer tablets. On an unknown date in February 2008, the patient experienced 15 shingles flair ups, with blistering, and internal pain, on her left side, upper hemisphere. The patient sought medical attention. She received acyclovir 800 mg, 5 times daily for the adverse event. No laboratory diagnostic studies were performed. The outcome of shingles was not reported. The relatedness between the adverse event of shingles and ZOSTAVAX was not reported. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Injection site rash, Vaginal infection, Vaginal ulceration
Clinical narrative: This spontaneous report was received from a a consumer who also is a company representative concerning her family member, who is a 60 year old patient. The patient had no pertinent medical history or concomitant therapies. The patient's drug reactions or allergies were unknown. On 01-FEB-2017, the patient was vaccinated with a dose of ZOSTAVAX which was diluted in sterile diluent (manufacturer unknown), subcutaneously (the lot #, expiration date, and strength were not reported for any therapy) for shingles prevention (prophylaxis).  Soon after, on an unspecified date in 2017, the patient developed a rash at the injection site. Afterwards, the patient went to see a dermatologist about the rash, and the dermatologist confirmed that it was a slight shingles outbreak from the ZOSTAVAX injection. On 07-APR-2017, the patient was diagnosed with a vaginal infection that seemed to be an ulcerative infection, and her obstetrician-gynecologist (OBGYN) physician told her that the infection was the result of the vaccination. The patient received an unspecified treatment for the adverse events. At the time of this report, the patient was recovering from the events.  The reporter did not provided the causality assessment between the events and ZOSTAVAX. Additional information has been requested.
Age: 10.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Cellulitis, Skin lesion
Clinical narrative: This information has been received from a nurse prescriber concerning a 10 year old male patient. The patient had no pertinent medical history, drug allergies or concomitant therapies. On 13-APR-2017, the patient was vaccinated with PNEUMOVAX 23 with lot number M013156 and expiration date on 15-OCT-2017 (dose, dose number and anatomical location were not provided), administered intramuscularly for "Cochlear implants, recommended by pediatrician". The reporter stated that within 4 hours, dime-sized lesions started, then kept growing, and within 24 hours he was admitted to an unspecified hospital for cellulitis and treated with two unspecified antibiotics. The patient was discharged after 3 days. At the time of the report, the patient had recovered from the cellulitis and the causal relationship between PNEUMOVAX 23 and the event was unknown. Upon internal review, cellulitis was determined to be medically significant. Additional information has been requested.
Age: 10.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Blood test abnormal, Erythema, Infection, Pain, Pyrexia
Clinical narrative: This information has been received from a nurse prescriber concerning a 10 year old male patient. The patient had no pertinent medical history, drug allergies or concomitant therapies. On 13-APR-2017, the patient was vaccinated with PNEUMOVAX 23 with lot number M013156 and expiration date on 15-OCT-2017 (dose, dose number and anatomical location were not provided), administered intramuscularly for "Cochlear implants, recommended by pediatrician". The reporter stated that within 4 hours, dime-sized lesions started, then kept growing, and within 24 hours he was admitted to an unspecified hospital for cellulitis and treated with two unspecified antibiotics. The patient was discharged after 3 days. At the time of the report, the patient had recovered from the cellulitis and the causal relationship between PNEUMOVAX 23 and the event was unknown. Upon internal review, cellulitis was determined to be medically significant. Additional information has been requested.
Age: 10.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Skin swelling, Skin warm
Clinical narrative: This information has been received from a nurse prescriber concerning a 10 year old male patient. The patient had no pertinent medical history, drug allergies or concomitant therapies. On 13-APR-2017, the patient was vaccinated with PNEUMOVAX 23 with lot number M013156 and expiration date on 15-OCT-2017 (dose, dose number and anatomical location were not provided), administered intramuscularly for "Cochlear implants, recommended by pediatrician". The reporter stated that within 4 hours, dime-sized lesions started, then kept growing, and within 24 hours he was admitted to an unspecified hospital for cellulitis and treated with two unspecified antibiotics. The patient was discharged after 3 days. At the time of the report, the patient had recovered from the cellulitis and the causal relationship between PNEUMOVAX 23 and the event was unknown. Upon internal review, cellulitis was determined to be medically significant. Additional information has been requested.
Sex: F
Vaccine: MMR
Symptoms: Computerised tomogram head abnormal, Cough, Ear congestion, Ear discomfort, Influenza virus test negative
Clinical narrative: This literature report was received from the authors of the published article as cited below refers to a 45 years old female patient. The patient's medical history was only notable for kidney stones, hysterectomy secondary to fibroids and cystoscopy with ureteral stone retrieval. She denied any drugs or alcohol and denied tobacco use. The patient reported being up to date with her immunization. The literature article presented a case of mumps in an immunized adult diagnosed in the emergency department, highlighting the importance of maintaining consideration and vigilance for this entity even in an immunized adult. On an unknown date the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(Manufacturer Unknown) (dose, frequency, route not reported) for prophylaxis. On an unknown date the patient presented to the emergency department (ED) for evaluation of "swollen neck" which started upon awakening the day of presentation. The patient reports that for several days prior, she was having nasal congestion, cough, bilateral ear pressure, and fullness, as well as a sore throat. Given the patient's presentation and workup, mumps was given top consideration. Laboratory findings include a white blood cell count of 11.6 x 10^3 (units not specified). Serum basic metabolic panel was unremarkable. Influenza swabs were negative. A computed tomographic scan of the facial bones with contrast showed an enlargement of parotid glands bilaterally with mild infiltration of the adjacent subcutaneous fat. There were no salivary duct stone and there were no soft tissue abscess noted. The airways were patent. The patient was seen by her family doctor and she was prescribed a Methylprednisolone (MEDROL DOSEPAK), Fluticasone propionate(FLONASE), Guaifenesin (MUCINEX). She reports that she took the medication and felt relief of her bilateral ear pressure the next day. Subsequently, Immunoglobulin M (IgM) and Immunoglobulin G (IgG) antibodies to the mumps virus came back positive. Follow-up with the patient's family doctor revealed that the patient did well after her ED visit and had no complications from mumps. The authors considered the event, vaccination failure to be related to the suspect therapy. Additional information has been requested.
Sex: F
Vaccine: MMR
Symptoms: Local swelling, Metabolic function test normal, Mumps, Nasal congestion, Neck pain
Clinical narrative: This literature report was received from the authors of the published article as cited below refers to a 45 years old female patient. The patient's medical history was only notable for kidney stones, hysterectomy secondary to fibroids and cystoscopy with ureteral stone retrieval. She denied any drugs or alcohol and denied tobacco use. The patient reported being up to date with her immunization. The literature article presented a case of mumps in an immunized adult diagnosed in the emergency department, highlighting the importance of maintaining consideration and vigilance for this entity even in an immunized adult. On an unknown date the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(Manufacturer Unknown) (dose, frequency, route not reported) for prophylaxis. On an unknown date the patient presented to the emergency department (ED) for evaluation of "swollen neck" which started upon awakening the day of presentation. The patient reports that for several days prior, she was having nasal congestion, cough, bilateral ear pressure, and fullness, as well as a sore throat. Given the patient's presentation and workup, mumps was given top consideration. Laboratory findings include a white blood cell count of 11.6 x 10^3 (units not specified). Serum basic metabolic panel was unremarkable. Influenza swabs were negative. A computed tomographic scan of the facial bones with contrast showed an enlargement of parotid glands bilaterally with mild infiltration of the adjacent subcutaneous fat. There were no salivary duct stone and there were no soft tissue abscess noted. The airways were patent. The patient was seen by her family doctor and she was prescribed a Methylprednisolone (MEDROL DOSEPAK), Fluticasone propionate(FLONASE), Guaifenesin (MUCINEX). She reports that she took the medication and felt relief of her bilateral ear pressure the next day. Subsequently, Immunoglobulin M (IgM) and Immunoglobulin G (IgG) antibodies to the mumps virus came back positive. Follow-up with the patient's family doctor revealed that the patient did well after her ED visit and had no complications from mumps. The authors considered the event, vaccination failure to be related to the suspect therapy. Additional information has been requested.
Sex: F
Vaccine: MMR
Symptoms: Oropharyngeal pain, Parotid gland enlargement, Rubulavirus test positive, Vaccination failure, White blood cell count increased
Clinical narrative: This literature report was received from the authors of the published article as cited below refers to a 45 years old female patient. The patient's medical history was only notable for kidney stones, hysterectomy secondary to fibroids and cystoscopy with ureteral stone retrieval. She denied any drugs or alcohol and denied tobacco use. The patient reported being up to date with her immunization. The literature article presented a case of mumps in an immunized adult diagnosed in the emergency department, highlighting the importance of maintaining consideration and vigilance for this entity even in an immunized adult. On an unknown date the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(Manufacturer Unknown) (dose, frequency, route not reported) for prophylaxis. On an unknown date the patient presented to the emergency department (ED) for evaluation of "swollen neck" which started upon awakening the day of presentation. The patient reports that for several days prior, she was having nasal congestion, cough, bilateral ear pressure, and fullness, as well as a sore throat. Given the patient's presentation and workup, mumps was given top consideration. Laboratory findings include a white blood cell count of 11.6 x 10^3 (units not specified). Serum basic metabolic panel was unremarkable. Influenza swabs were negative. A computed tomographic scan of the facial bones with contrast showed an enlargement of parotid glands bilaterally with mild infiltration of the adjacent subcutaneous fat. There were no salivary duct stone and there were no soft tissue abscess noted. The airways were patent. The patient was seen by her family doctor and she was prescribed a Methylprednisolone (MEDROL DOSEPAK), Fluticasone propionate(FLONASE), Guaifenesin (MUCINEX). She reports that she took the medication and felt relief of her bilateral ear pressure the next day. Subsequently, Immunoglobulin M (IgM) and Immunoglobulin G (IgG) antibodies to the mumps virus came back positive. Follow-up with the patient's family doctor revealed that the patient did well after her ED visit and had no complications from mumps. The authors considered the event, vaccination failure to be related to the suspect therapy. 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 certified medical assistant and refers to an unknown number of unspecified patients of unknown demographics. No information regarding any of the patients' medical history, concomitant medications and concurrent conditions was provided. On unknown dates in 2017, between 01-FEB-2017 and 04-MAY-2017, the patients were vaccinated with doses of improperly stored GARDASIL 9 (lot # N002720, expiration date: 12-MAY-2019). The vaccine was stored in a temperature between 47 and 77 degrees Fahrenheit for 2256 hours. No previous temperature excursions were reported, the Digital Data Logger was not involved. No adverse events were reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1705USA004568: US-009507513-1705USA004567: US-009507513-1705USA004569:
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant and refers to an unknown number of unspecified patients of unknown demographics. No information regarding any of the patients' medical history, concomitant medications and concurrent conditions was provided. On unknown dates in 2017, between 01-FEB-2017 and 04-MAY-2017, the patients were vaccinated with doses of improperly stored VARIVAX (lot number: M035142, expiration date: 03-AUG-2018 and lot number: M036292, expiration date: 17-AUG-2018; dose and route of administration were not reported). The vaccine was stored in a temperature between -14 and -10 degrees Celsius for 2256 hours. No previous temperature excursions were reported, the Digital Data Logger was not involved. A properly stored sterile diluent was used to reconstitute the doses of VARIVAX. No adverse events were reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1705USA004513: US-009507513-1705USA004568: US-009507513-1705USA004569:
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant and refers to an unknown number of unspecified patients of unknown demographics. No information regarding any of the patients' medical history, concomitant medications and concurrent conditions was provided. On unknown in 2017, dates between 02-FEB-2017 and 04-MAY-2017, the patients were vaccinated with doses of improperly stored PROQUAD (lot number: M036158, expiration date: 12-FEB-2018, lot number: M038860, expiration date: 13-MAR-2018; albumin status therapy type, dose and route of administration were not reported). The vaccine was stored in a temperature between -14 and -10 degrees Celsius for 2256 hours. No previous temperature excursions were reported, the Digital Data Logger was not involved. A properly stored sterile diluent was used to reconstitute the doses of PROQUAD. No adverse events were reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1705USA004513: US-009507513-1705USA004569: US-009507513-1705USA004567:
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant and refers to an unknown number of unspecified patients of unknown demographics. No information regarding any of the patients' medical history, concomitant medications and concurrent conditions was provided. On unknown dates in 2017, between 01-FEB-2017 and 04-MAY-2017, the patients were vaccinated with doses of improperly stored ROTATEQ oral liquid (lot number: M031553, expiration date: 19-MAR-2018 and lot number M038847, expiration date: 27-APR-2018, dose was not reported). The vaccine was stored in a temperature between 47 and 77 degrees Fahrenheit for 2256 hours. No previous temperature excursions were reported, the Digital Data Logger was not involved. No adverse events were reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1705USA004568: US-009507513-1705USA004513: US-009507513-1705USA004567:
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist, concerning unspecified number of patients of unknown age and gender. There were no concurrent conditions, medical history, drug reactions, allergies or concomitant medications reported. On unspecified dates, the patients were vaccinated with improperly stored doses ("less than 10," but exact number was not specified) of ZOSTAVAX vial (dose, frequency, route, lot # and expiration date were not reported) for prophylaxis. The ZOSTAVAX doses were reconstituted with sterile diluents (lot # and expiration date were not reported). The temperature excursion of the ZOSTAVAX was between 15 °F and 46 °F for a time frame of 30 minutes. No previous temperature excursion was reported. No adverse effects were reported and no data logger was involved. This is one of two reports received from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1705USA004616: