chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: FLUN4, HPV9, MNQ, TD
Symptoms: Pallor, 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-609782). This spontaneous report refers to a 13 year old male patient. The patient had no medical history, concurrent conditions and concomitant medications. On 13-NOV-2015 the patient was vaccinated with GARDASIL 9 dose 1 (unspecified dose and frequency), intramuscular for prophylaxis. Other suspect therapies included FLUMIST dose 3, intranasal for prophylaxis, diphtheria toxoid, tetanus toxoid(TD), dose 1, intramuscular for prophylaxis and MENACTRA, dose 1, intramuscular for prophylaxis. After receiving all the vaccinations, on the same day the patient experienced pallor (pale) and syncope (fainted). The outcome of pallor and 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.
Sex: M
Vaccine: HPV9
Symptoms: Blood glucose normal, Hyperhidrosis, Loss of personal independence in daily activities, Malaise, 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 # 610357) on 04-APR-2017. This spontaneous report was received from a regulatory authority refers to a 15 years old male patient. The patient had no concurrent illnesses and medical history. Information on the patient's prior vaccinations and other medications were not reported. On 18-NOV-2015, the patient received the first shot of GARDASIL 9 at 9:15 am lot # L013429, in the left arm via unknown route for prophylaxis (dosage and expiry date unspecified). The patient was scheduled to have blood work drawn after having shot. On same day, about 5 minutes after waiting in the room, the patient went back into the room for a check, then the patient became nauseous, sweaty and felt ill. The patient did have a pale pallor. The patient was made to lay down and blood pressure was measured, it was 122/76 manually in his left arm sitting. Finger stick blood sugar was 93, fasting. The patient stated that he had not eaten any breakfast in the morning. Doctor instructed the patient to hold off having blood work done until next week. The patient and his mother verbalized understanding. The patient was given peanut butter crackers and a can of Coca Cola in office. At 9:40 am, the patient stated that he was feeling better. The patient's mother asked if the patient should be kept home from school that day. She was informed that it was up to her. The patient and his mother decided to stay back home from school. It was advised to them to get a note for school from the front desk. The patient and his mother verbalized understanding. The patient required emergency room visit. The outcome of blood glucose normal, pallor, nausea, malaise and hyperhidrosis was reported as recovered. Causality for the events were not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: M
Vaccine: HPV9
Symptoms: Pallor
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 # 610357) on 04-APR-2017. This spontaneous report was received from a regulatory authority refers to a 15 years old male patient. The patient had no concurrent illnesses and medical history. Information on the patient's prior vaccinations and other medications were not reported. On 18-NOV-2015, the patient received the first shot of GARDASIL 9 at 9:15 am lot # L013429, in the left arm via unknown route for prophylaxis (dosage and expiry date unspecified). The patient was scheduled to have blood work drawn after having shot. On same day, about 5 minutes after waiting in the room, the patient went back into the room for a check, then the patient became nauseous, sweaty and felt ill. The patient did have a pale pallor. The patient was made to lay down and blood pressure was measured, it was 122/76 manually in his left arm sitting. Finger stick blood sugar was 93, fasting. The patient stated that he had not eaten any breakfast in the morning. Doctor instructed the patient to hold off having blood work done until next week. The patient and his mother verbalized understanding. The patient was given peanut butter crackers and a can of Coca Cola in office. At 9:40 am, the patient stated that he was feeling better. The patient's mother asked if the patient should be kept home from school that day. She was informed that it was up to her. The patient and his mother decided to stay back home from school. It was advised to them to get a note for school from the front desk. The patient and his mother verbalized understanding. The patient required emergency room visit. The outcome of blood glucose normal, pallor, nausea, malaise and hyperhidrosis was reported as recovered. Causality for the events were not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Differential white blood cell count, Full blood count, Hypersensitivity
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-615694). This spontaneous report refers to a 11 year old female patient. The patient had no medical history, concurrent conditions and concomitant medications. On 16-DEC-2015 the patient went to clinic and was vaccinated with GARDASIL 9 lot # L016428 dose 1 (dose and frequency unknown), in the left arm for prophylaxis.  Other suspect therapies included BOOSTRIX dose 1, in the left arm and MENVEO dose 1 in the right arm for prophylaxis. On 16-DEC-2015, the patient experienced hypersensitivity. Differential white blood cell count and full blood count were performed according to the doctor's order. On 18-DEC-2015, the patient paid a follow-up visit to the clinic due to possible allergic reaction to vaccines. Her parents applied warm compressors at the affected area. The patient was asked to follow-up on 21-DEC-2015. The outcome of differential white blood cell count, hypersensitivity and full blood count was reported as unknown. Causality assessment was not provided. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 18.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Injection site swelling
Clinical narrative: Swelling of upper (L) arm below injection site.
Age: 10.0
Sex: F
Vaccine: HPV4, TDAP, HPV4, TDAP
Symptoms: Abdominal pain upper, Back pain, Headache, Laboratory test, Menorrhagia
Clinical narrative: Since admin of GARDASIL pt has had many c/o pain in spine, abd, pelvis. Has seen many specialists and has had multiple admissions to the hospital.
Age: 10.0
Sex: F
Vaccine: HPV4, TDAP, HPV4, TDAP
Symptoms: Pelvic pain, Rash
Clinical narrative: Since admin of GARDASIL pt has had many c/o pain in spine, abd, pelvis. Has seen many specialists and has had multiple admissions to the hospital.
Age: 10.0
Sex: F
Vaccine: HPV4, TDAP, HPV4, TDAP
Symptoms: Abdominal pain, Imaging procedure, Laboratory test, Pelvic pain, Spinal pain
Clinical narrative: Since admin of GARDASIL pt has had many c/o pain in spine, abd, pelvis. Has seen many specialists and has had multiple admissions to the hospital.
Age: 15.0
Sex: F
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse, concerning an unspecified number of patients of an unknown gender and age. There were no concurrent conditions, medical history, drug reactions or allergies or concomitant medications reported. On an unspecified dates, the patients were vaccinated with improperly stored doses PROQUAD (dose, frequency and route were not reported) lot # M042499 with expiration date of 17-APR-2018. The temperature of the PROQUAD was between 6 °F and 14 °F for a time frame of 1 hour and 30 minutes; no previous temperature excursion was reported. No adverse effects were reported and no product quality complaint (PQC) was involved. Data logger was involved. This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1704USA001755:
Sex: U
Vaccine: HPV9, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, concomitant medications and concurrent conditions were not reported. It was reported that on an unknown date, the patient may had received an improperly stored dose of GARDASIL 9 lot # M036059 for prophylaxis (expiration date: 03-JUN-2019; dose, dose number, frequency and route of administration were not reported).  Or may may had received an improperly stored dose of ROTATEQ orally, lot # M031807 for prophylaxis (expiration date: 02-APR-2018; dose, dose number and frequency were not reported). The medical assistant was not sure which of the vaccines the patient received. No adverse effect reported. The vaccines were exposed to a temperature between 47 Fahrenheit degrees and 77 Fahrenheit degrees for 406 hours and 56 minutes. There was no previous temperature excursion. The call was placed because of a Digital Data logger report. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: MMR
Symptoms: No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse, concerning a non-pregnant 26 year-old female patient. There were no medical history, drug reactions or allergies reported. On 11-APR-2017, the patient, who had lupus, was subcutaneously vaccinated with a dose of M-M-R II injection (dose and frequency were not reported) lot # M037096 with expiration date of 23-AUG-2018, with diluent MRK (lot # and expiration date were not reported). The patient did not sought medical attention. No adverse effects were reported. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site oedema, Injection site rash, Vaccination site cellulitis
Clinical narrative: This spontaneous report as received from a other health professional refers to a 12 month old female patient. The patient had no medical history, concurrent conditions or concomitant medications. On 10-MAR-2017, the patient was vaccinated with a dose of VARIVAX subcutaneously, (lot # M023383, with an expiration date in 11-MAY-2018), for immunization (dose, dose number, frequency and strength were not provided). On 22-MAR-2017, 13 days after onset of therapy the patient experienced "rash, redness, edema at injection site", the patient was diagnosed with vaccination site cellulitis and treated with sulfamethoxazole trimethoprim (BACTRIM). The nurse requested VZV packet to be sent, no product quality complaint (PQC) was involved. Additionally, it was reported that there was no intervention to prevent serious criteria and the patient was not hospitalized or experienced a significant incapacity nor disability. At the time of reporting, the outcome of vaccination site cellulitis was unknown. The causal relationship between vaccination site cellulitis and VARIVAX was not provided. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Register Nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, drugs reactions or allergies and concomitant therapies were not provided. On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX with lot # M036293 and expiration date of 17-AUG-2018 (route of administration, dose and anatomical location were unknown) for prophylaxis; reconstitued with sterile diluent (lot # and expiration date were not provided). The vaccine was exposed to a temperature excursion of  6°F to 14°F with a time frame of 45 minutes, while the sterile water diluent did not undergo a temperature excursion. There was no previous temperature excursion. A "data logger" was involved. No adverse effects were reported. There was not product quality complaint involved. This is one of the two reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA012630:
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site reaction, Local reaction
Clinical narrative: This spontaneous report has been received from a pharmacist and referred to a patient of an unknown age and gender. The patient's relevant medical history, concurrent conditions, and concomitant therapies were not reported. The pharmacist was informed by a nurse, that on an unknown date, the patient was vaccinated with ZOSTAVAX (dose, frequency, lot number, and expiration date were not reported) administered intramuscularly (rather than subcutaneously) for prophylaxis that was reconstituted using sterile diluent (MRK) (lot number and expiration date were not provided). According to the reporter, the patient experienced an unspecified localized reaction at the injection site as well as pain in the arm where the vaccine was administered. At the time of this report, the outcome of the vaccination site reaction and vaccination site pain was unknown. The causality assessment between vaccination site reaction and vaccination site pain with ZOSTAVAX and sterile diluent (MRK) was unknown. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report was received from a physician, concerning a male patient of an unknown age. There were no concurrent conditions, medical history, drug reactions or allergies or concomitant medications reported. On 19-APR-2017, at a pharmacy, the patient was vaccinated with a dose of ZOSTAVAX vial (dose, frequency, route, lot # and expiration date were not reported) for prophylaxis. On 21-APR-2017, he went to the physician's office with a 9 cm by 9 cm injection site swelling, redness, tenderness and painful area. He did not have rash, itching, shortness of breath or fever. On an unspecified date in April 2017, the patient received BENADRYL as treatment and it was unknown whether or not this treatment provided relief to him. At the time of the report, the outcome of the adverse events was unknown. The causality between the adverse events and ZOSTAVAX was unknown. Additional information has been requested.
Age: 72.0
Sex: M
Vaccine: PPV
Symptoms: Chest X-ray, Pneumonia
Clinical narrative: This spontaneous report was received from a 79 years-old male patient, reporting on himself. The patient's did not have pertinent medical history. His concurrent conditions included the allergy to horse serum. The concomitant medications were not provided. On an unspecified date in 2009, the patient was vaccinated with a single dose of PNEUMOVAX 23 (Lot #, expiration date, strength and route of administration were not provided), in his left shoulder area, for pneumonia prevention. It was also mentioned by the patient that at some point (dates unspecified), he was also vaccinated with PREVNAR 13. On an unspecified date in approximately March 2017 (reported as "about 5 weeks ago"), the patient developed pneumonia. He sought medical attention by going to the physician and was hospitalized for 2 days. He was given an unspecified treatment for the event and a chest X ray was performed (results not provided). At the reporting time, the patient had already recovered from the pneumonia. The relatedness between the event and the vaccines was not reported. Upon internal review. pneumonia was considered to be medically significant. No product quality complaint (PQC) was involved. Additional information has been requested.
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unspecified date in 2016 (reported as "1 years ago"), the patient was vaccinated with the first dose of GARDASIL 9 (strength, dose, route, lot number and expiration date were not reported) for prophylaxis. The pharmacist reported that the patient had not received the second dose and at the time of reporting, the patient was in the pharmacy to received her second dose of GARDASIL 9 lot #M033583, expiration date 20-APR-2019 (product use issue). Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a pharmacist via a company representative concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX injection, by subcutaneous route (strength, dose, lot number and expiration date were not reported) for prevention of shingles. The pharmacist reported that the patient was getting the shingles virus (herpes zoster) after receiving the ZOSTAVAX on an unknown date. No symptoms were reported. At the time of the report, the outcome of the event was not reported. The causality assessment between the event and the ZOSTAVAX was not reported. Additional information is not expected as the reporter did not consent for follow attempts.
Age: 52.0
Sex: M
Vaccine: PPV
Symptoms: Injection site joint movement impairment, Injection site pain, Malaise
Clinical narrative: This spontaneous report was received from a medical assistant, concerning a 52 year-old male patient. His concurrent conditions included asthma, benign prostatic hypertrophy, chronic obstructive pulmonary disease, diverticulosis and hypertension. There were no historical conditions or drug reactions or allergies reported. The patient's concomitant medications included amlodipine besylate (NORVASC), cholestyramine, pantoprazole sodium (PROTONIX), morniflumate (FLOMAX), albuterol inhaler (manufacturer unknown), losartan (manufacturer unknown) and ranitidine hydrochloride (ZANTAC). On 13-APR-2017, the patient was intramuscularly vaccinated with a dose of PNEUMOVAX23 injection (dose and frequency were not reported) lot # N003997 with expiration date of 20-OCT-2018, for prevention of pneumonia. On 14-APR-2017, the patient experienced injection site soreness, decreased range of motion in the arm where injection was received and the patient stated that he "just did not felt well." The patient went to the emergency room and an unspecified treatment was given for the adverse events; no laboratory diagnostics studies were performed. On an unspecified date in 2017, the patient recovered from the mentioned adverse events. The causality between the adverse events and PNEUMOVAX23 was unknown. 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: This spontaneous report was received from a medical assistant, referring to an unspecified number of patients of unknown genders and ages. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On an unknown date, the patients were vaccinated with improperly stored dose of ROTATEQ (strength, dose, route of administration, lot # and expiration date were not reported) for prophylaxis, however no adverse effects were reported. It was reported that the vaccine was exposed to temperature of 23 centigrade degree (°C) to  1.9 °C range for an unknown time frame. The temperature excursion was recorded by a data logger and no previous excursions were reported for the vaccines. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1705USA001224:
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant, referring to an unspecified number of patients of unknown genders and ages. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On an unknown date, the patients were vaccinated with improperly stored dose of GARDASIL 9 (strength, dose, route of administration, lot # and expiration date were not reported) for prophylaxis, however no adverse effects were reported. It was reported that the vaccine was exposed to temperature of 23 centigrade degree (°C) to  1.9 °C range for an unknown time frame. The temperature excursion was recorded by a data logger and no previous excursions were reported for the vaccines. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1705USA000314:
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, HIBV, PNC, RV5
Symptoms: Extra dose administered, Haematemesis, Pyrexia
Clinical narrative: Initial unsolicited misuse report received from the nurse on 21 April 2017. This case involves a 6 months old female patient who was inadvertently vaccinated with a dose of PENTACEL (batch number- C5241AA, expiry date-03 December 2017) via intramuscular route in left thigh; a dose of ACTHIB (batch number- UI727AAA, expiry date-21 November 2017) via intramuscular route in right thigh 06 April 2017.On same day the patient received dose of PREVNAR (batch number- R37130) via unknown route in right thigh and a dose of ROTAVIRUS VACCINE (ROTAVIRUS) (batch number-M031807) via oral route of administration. The patient had allergic to lactose. Illness at the time of vaccination and other medical history was none. Concomitant medications were not reported. On 06 April 2017, same day following the vaccination, the patient experienced fever (reported as stated mother of patient called on call doctor on evening reporting her daughter had a fever). On 07 April 2017, one day following the vaccination (at 04:00 pm) patient's mother reported that patient had started vomiting dark red blood. It was a case of extra dose administered. The patient was seen in the ER (emergency room). Lab data was not reported. Had been advised to administer Tylenol for fever. On an unspecified date the patient was recovered from all events and was discharged from ER room. Upon internal review, the case was considered as serious due to important medical event: vomiting dark red blood. On an unspecified date the patient was discharge. List of documents held by sender: none. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments: This case concerns a 6 months old female patient with a history of lactose allergy received PENTACEL), ACT-HIB, PREVNAR and ROTAVIRUS VACCINE and was vomiting blood on the next day of vaccination. Time to onset is compatible with the role of vaccine. Lactose allergy could be a possible cause for the event. Moreover, as multiple vaccines were administered concomitantly, the role of each component cannot be assessed separately.
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Thyroid cancer, Thyroidectomy
Clinical narrative: Received GARDASIL 9 shot and developed thyroid cancer at age 25.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site oedema, Injection site pruritus, Injection site warmth
Clinical narrative: This patient received zoster vaccine on 4/27/17 on Rt. arm subcutaneously and developed Rt. arm redness, mild edema, warmth, and itchiness on injection site. Patient denies pain, discharge.
Age: 72.0
Sex: M
Vaccine: HEP, PPV
Symptoms: Death, Dyspnoea, Paraesthesia, Resuscitation, Unresponsive to stimuli
Clinical narrative: Hemodialysis Patient receiving hemodialysis at approx 0934 pre BP 143/70, pulse 65. At approx 1204 BP 102/43, pulse 65. Patient was administered first dose of MIRCERA 100mcg IVP at 1158, Pneumococcal vaccine 23 IM 0.5ml at 1200, RECOMBIVAX 40mcg IM at 1201. At approx 1205 patient reported tingling in his ears and complained of shortness of breath, and then became unresponsive. CPR was initiated at 1205, 911 called, EMS arrived and transported patient at approx 1245 to hospital ER. Patient expired in ER.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Decreased appetite, Erythema, Lethargy, Pain, Pyrexia
Clinical narrative: At Noon he became lethargic, loss of appetite. A healthy baby went from just that to unable to move on the floor in PAIN. His fever started around noon at 100.3 and crept up to 103.5 degrees by 6 pm. By 6 pm he was still lethrgic and unresponsive his face was bright red and then he began projectile vomiting which he had never done before. As a baby he had never even spit up but twice (I brestfed). And he had only had a few vaccines up until that point, he had not followed the RECCOMMENDED vaccine schedule,whose vaccines were was just recently deemed "unavoidably unsafe". Anyways he did break his fever, and then he slept for far longer than what he usually sleeps and recovered completely.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Unresponsive to stimuli, Vomiting projectile
Clinical narrative: At Noon he became lethargic, loss of appetite. A healthy baby went from just that to unable to move on the floor in PAIN. His fever started around noon at 100.3 and crept up to 103.5 degrees by 6 pm. By 6 pm he was still lethrgic and unresponsive his face was bright red and then he began projectile vomiting which he had never done before. As a baby he had never even spit up but twice (I brestfed). And he had only had a few vaccines up until that point, he had not followed the RECCOMMENDED vaccine schedule,whose vaccines were was just recently deemed "unavoidably unsafe". Anyways he did break his fever, and then he slept for far longer than what he usually sleeps and recovered completely.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse, referring to multiple unspecified patients of unknown age and gender.  Information about patients' medical history, concurrent conditions and concomitant medication were not reported. On unspecified dates, the patients were administered doses of improperly stored ROTATEQ (lot # M014544 expiration date: 27-NOV-2017 and lot # M040269 expiration date: 28-APR-2018). The vaccines were exposed to 32 to 35 Fahrenheit degree for 2 hours. No previous excursions. A data logger was used. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA004034: US-009507513-1704USA004041: US-009507513-1704USA004042:
Age: 22.0
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information was received from an office manager concerning a 22 year old male patient. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On 31-OCT-2016, the patient was vaccinated with his first dose of GARDASIL 9. On 23-FEB-2017, the patient was vaccinated with his second dose of GARDASIL 9. The third dose of the GARDASIL 9 was given on 24-APR-2017 (lot numbers, dosages, and routes of administration not provided). It was realized after the patient was vaccinated that he was not on schedule and there were not enough months between the 2nd and 3rd dose. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a pharmacist concerning a patient of unknown age and gender with no information reported regarding the patient's past medical history, concurrent conditions, or concomitant medication. The pharmacist reported that an unspecified patient received one dose of an unspecified HPV vaccine (manufacturer unknown) in approximately 2012-2013 (reported as "about 4 to 5 years ago") (lot number, dosage, and route of administration not provided). The pharmacist reported that the patient received a dose of GARDASIL 9 on 20-APR-2017 (reported as "last Thursday") as the second dose in the HPV vaccination series (dosage and route of administration not provided) (lot # M032650, expiration date 31-MAR-2019). No adverse effects were reported. No additional information is available. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information was received from a nurse who reported that on unknown dates, multiple unspecified patients were vaccinated with improperly stored GARDASIL 9, RECOMBIVAX HB, VAQTA, and ROTATEQ (lot numbers, expiration dates, dosages, and routes of administration unknown). No adverse effects reported. Excursion information: Temperature: 32°F to 35°F Time frame: 1 hour 40 minutes Previous temperature excursion: No Involved "data logger"? Yes. No further information provided. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a register nurse and refers to a patient of unknown age an gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. The nurse reported that on 24-APR-2017, the patient inadvertently received an expire dose of PNEUMOVAX23 lot # K020215, expiration date May 2016 (dose and route were not reported) for prophylaxis. No adverse effect was reported. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: HPV4
Symptoms: Hypotonia, Limb discomfort
Clinical narrative: This spontaneous report was received from a registered nurse who is also the mother of the patient, via a company representative, regarding a currently 13 year old male patient. The patient did not have a pertinent medical history and was not taking concomitant medications. The patient's drug allergies were unknown by the reporter. In April 2015 (reported as "2 years ago"), the patient was vaccinated with a dose of GARDASIL injection (dose, route, lot number and expiration date were unknown by the reporter) for prevention of Human Papillomavirus (HPV). On unspecified dates (reported as "in two occasions after receiving each dose of GARDASIL"), the patient's arm felt "limp/heavy". This adverse experience lasted for about an hour or two after each injection. On an unknown date (reported as "the day after each injection"), the patient recovered from the events. It was unknown if the patient received a third dose of GARDASIL. No treatment was given for the events not laboratory diagnostic studies were performed. The patient did not seek medical attention for the events and no intervention was performed to prevent serious criteria. The reporter did not provide a causality assessment between the suspect therapy and the events muscular weakness and limb discomfort. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant concerning a multiple unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of VAQTA lot numbers: K026529, L009445, L018499, L028666, K018181, L023936, L045713, M009377, L015460, M018644, M022924, M033611 and M039202 (strength, dose, route of administration and expiration dates were not reported) for prophylaxis. It was reported that all vaccines involved in temperature excursion were vaccines for children (VFC). The administered doses of VAQTA were exposed to temperature excursions between 26° (unspecified units) (lowest) and 75° (unspecified units) (highest) for 12 hours each day, from 15-DEC-2015 to 31-MAR-2017. No adverse effects were reported. A digital data logger was involved. This is one of several reports received from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1703USA007467: US-009507513-1705USA001209: US-009507513-1705USA001210: US-009507513-1705USA001211: US-009507513-1705USA001212:
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant concerning a multiple unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB lot numbers: J013394, K020216, K026666, L000877, L025738, L027733, L040458, L048848 and M034894 (strength, dose, route of administration and expiration dates were not reported) for prophylaxis.  It was reported that all vaccines involved in temperature excursion were vaccines for children (VFC). The administered doses of RECOMBIVAX HB were exposed to temperature excursions between 26° (unspecified units) (lowest) and 75° (unspecified units) (highest) for 12 hours each day, from 15-DEC-2015 to 31-MAR-2017. No adverse effects were reported. A digital data logger was involved. This is one of several reports received from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1703USA007467: US-009507513-1705USA001208: US-009507513-1705USA001210: US-009507513-1705USA001211: US-009507513-1705USA001212:
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant concerning a multiple unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot numbers: K026247, L011846, L013429, L020015, L024993, L026602, M009378, M017983 and M028323 (strength, dose, route of administration and expiration dates were not reported) for prophylaxis. It was reported that all vaccines involved in temperature excursion were vaccines for children (VFC). The administered doses of GARDASIL 9 were exposed to temperature excursions between 26° (unspecified units) (lowest) and 75° (unspecified units) (highest) for 12 hours each day, from 15-DEC-2015 to 31-MAR-2017. No adverse effects were reported. A digital data logger was involved. This is one of several reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1703USA007467: US-009507513-1705USA001208: US-009507513-1705USA001209: US-009507513-1705USA001211: US-009507513-1705USA001212.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant concerning a multiple unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of M-M-R II lot numbers: K005110, K014833, K021152, K024038, L005290, L011528, L012480, L020189, L030162, L032182, L037356, M007277 and M015930 (strength, dose, route of administration and expiration dates were not reported) for prophylaxis. It was reported that all vaccines involved in temperature excursion were vaccines for children (VFC). The administered doses of M-M-R II were exposed to temperature excursions between 26° (unspecified units) (lowest) and 75° (unspecified units) (highest) for 12 hours each day, from 15-DEC-2015 to 31-MAR-2017. No adverse effects were reported. A digital data logger was involved. This is one of several reports received from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1703USA007467: US-009507513-1705USA001208: US-009507513-1705USA001209: US-009507513-1705USA001210: US-009507513-1705USA001212:
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant concerning a multiple unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of VARIVAX lot numbers: K015943, K021487, L003775, L009203, L019124, L023587, L026407, L037559, L048468, L050560, M002061, M009765, M025870, M028553, M033906, M036272 and M041079 (strength, dose, route of administration and expiration dates were not reported) for prophylaxis.  It was reported that all vaccines involved in temperature excursion were vaccines for children (VFC). The administered doses of VARIVAX were exposed to temperature excursions between 26° (unspecified units) (lowest) and 75° (unspecified units) (highest) for 12 hours each day, from 15-DEC-2015 to 31-MAR-2017. No adverse effects were reported. A digital data logger was involved. This is one of several reports received from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1703USA007467: US-009507513-1705USA001208: US-009507513-1705USA001209: US-009507513-1705USA001210: US-009507513-1705USA001211:
Age: 48.0
Sex: F
Vaccine: MMR
Symptoms: Dysgeusia, Hypoaesthesia, Hypoaesthesia oral
Clinical narrative: Numbness in upper extremities/tongue/lips metallic taste.
Age: 29.0
Sex: F
Vaccine: MMR
Symptoms: Diarrhoea, Migraine, Pyrexia, Vision blurred
Clinical narrative: EE developed diarrhea in afternoon, then migraine headache, fever and blurred vision.
Age: 15.0
Sex: F
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Patient given MMRV at age 15 years. Cut off age for MMRV is 12 years.
Age: 3.0
Sex: M
Vaccine: DTAP, HEP, IPV
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Left leg (where Hep B and DTaP administered) became red, swollen, painful, itchy.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to unspecified patients of unknown demographics. The patients' pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On unspecified dates, the patients were vaccinated with improperly stored dose of GARDASIL 9 (lot# M036059, expiry date: 03-JUN-2019) (dosing details were not reported) for prophylaxis (incorrect product storage). Information regarding prior excursions was unknown. Temperature/Time Frame as follow: 32 Fahrenheit (F) to 35 F and 47 F to 77 F for 345 hours over a 90 day period. Call was not because of data logger. No adverse effects reported. No product quality complaint (PQC) was involved. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1705USA001551: US-009507513-1705USA001549: US-009507513-1705USA001550.
Sex: U
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse regarding a 16 year old patient of unknown gender. The patient's medical history, concurrent conditions, drug allergies or concomitant therapies were not reported. On 09-MAR-2017, the patient was inadvertently vaccinated with a dose of PROQUAD injection (dose and route were not reported) lot number: M042499; expiration date: 17-APR-2017, for prophylaxis. According to the reporter, receiving a dose of PROQUAD was not indicated as the patient had measles, mumps, rubella and varicella prevention in the medical history. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a nurse, concerning a patient of an unknown age and gender. There were no concurrent conditions, medical history, drug reactions or allergies or concomitant medications reported. On an unspecified date, the patient was vaccinated with a dose of VARIVAX injection (dose, frequency and route were not reported; indication: prophylaxis) lot # H018758 with expiration date of 11-OCT-2014, instead of intended M-M-R-II dose.  No product quality complaint (PQC) was involved. No adverse effects were reported. Additional information is not expected, as no consent to contact the reporter was granted.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to unspecified patients of unknown demographics. The patients' pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On an unknown date, the patients were vaccinated with improperly stored dose of ROTATEQ (lot# M032636, expiry date: 06-APR-2018) (route defaulted to oral) (dosing details were not reported) for prophylaxis (incorrect product storage). Information regarding prior excursions was unknown. Temperature/Time Frame as follow: 32 Fahrenheit (F) to 35 F and 47 F to 77 F for 345 hours over a 90 day period. Call was not because of data logger. No adverse effects reported. No product quality complaint (PQC) was involved. This is one of the several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA014865: US-009507513-1705USA001550: US-009507513-1705USA001551:
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: There was no adverse event, but the vaccine administered was expired/out-of-date.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Nausea, Vomiting
Clinical narrative: NAUSEA/VOMINTING, INJECTION SITE PAIN/SWELLILNG/REDNESS.
Age: 1.0
Sex: M
Vaccine: MMR, MMR, PNC13
Symptoms: Facial paralysis
Clinical narrative: Right sided facial nerve palsy.
Age: 1.0
Sex: M
Vaccine: MMR, MMR, PNC13
Symptoms: Facial paralysis, Mastoiditis
Clinical narrative: Right sided facial nerve palsy.
Age: 71.0
Sex: M
Vaccine: PNC13, PNC13
Symptoms: Injection site bruising, Injection site pain, Mobility decreased, Musculoskeletal pain, Peripheral swelling
Clinical narrative: Patient stated that arm is bruised at injection site, painful at injection site, and painful at shoulder. Patient also mentioned difficulty lifting arm. These symptoms have continued for 7 days despite treatment with tylenol and ice pack. Patient also mentioned swelling in left foot starting at day 6. Patient unsure if this was related.
Age: 71.0
Sex: M
Vaccine: PNC13, PNC13
Symptoms: Contusion, Injected limb mobility decreased, Injection site pain, Peripheral swelling
Clinical narrative: Patient stated that arm is bruised at injection site, painful at injection site, and painful at shoulder. Patient also mentioned difficulty lifting arm. These symptoms have continued for 7 days despite treatment with tylenol and ice pack. Patient also mentioned swelling in left foot starting at day 6. Patient unsure if this was related.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Headache, Pyrexia, Syncope
Clinical narrative: Headache, Chills, Fever and Faint throughout the night.  Fever reached at least 100.7 degrees. Low grade fever part of next morning.
Age: 51.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Erythema, Injection site erythema, Injection site pain, Musculoskeletal stiffness, Pyrexia
Clinical narrative: Patient reported stiffness in the neck and muscle pain around injection site. Pt also developed redness around the injection site and down the arm. Pt also developed a mild fever.
Age: 16.0
Sex: M
Vaccine: IPV, TD, TDAP
Symptoms: Wrong drug administered
Clinical narrative: Td and Tdap given at visit.  Incorrect second vaccine given.
Age: 0.0
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: IMMUNIZATIONS GIVEN AT 2 WEEKS OF AGE.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Rc'd. inj. to (L) deltoid - No discomfort until later in evening when entire deltoid became sore. The nxt. morning my bicep area was sore with redness over the bicep muscle - moderate swelling to area. Injection site never got painful - but pain and swelling persisted to my bicep muscle until late Fri. eve 4/7/17.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Injection site dryness, Injection site erythema, Injection site papule, Injection site rash, Injection site vesicles
Clinical narrative: Vaccines given and w/in 2 days blister at injection site and then eruption. Transverse line with vesicles and dryness/dry pink papules that was encouraged to be left alone and time to observe.
Age: 26.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain
Clinical narrative: I administered a flu shot to this emp who then C/O of pinching and burning in her (L) deltoid Ice was applied she was advised to us TYLENOL or Ibuprofen. She felt some better after 45 min. I followed up next day, she said burning and pinching gone but some soreness remained.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Rash generalised
Clinical narrative: Rash on entire body.
Age: 52.0
Sex: F
Vaccine: MMR, MNQ, PPV
Symptoms: Headache, Local swelling, Nausea, Pyrexia
Clinical narrative: 23 hours after administration, pt contacted office C/O fever localized swelling, nausea and headache - patient treated with TYLENOL and REGLAN.
Age: 22.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Nausea, Pruritus
Clinical narrative: Patient reports that she "felt fine" upon leaving health dept. but shortly afterward developed itchiness in her lower arms, dizziness, nausea. Patient called nurse line at facility and was told to go to ER. Seen at ER, treated with IV BENADRYL and 2 Epinephrine injections. Patient reports reaction started roughly 30 minutes after the injection.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Induration, Skin warm
Clinical narrative: Arm rock hard and hot to touch -area measured at 9 x 9 cm at MD. Grew to 12 x 12. Prescribed BENADRYL. Subsiding on 4-24-17.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness
Clinical narrative: Several minutes after receiving the HPV, the patient became lightheaded/dizzy. She leaned against door and slid to floor. Alert. Pt assisted back to exam room to lie down. Within 5-10 minutes, patient better. Seen by CRNP and discharged.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Induration, Malaise, Swelling
Clinical narrative: Redness, Firmness started 24 hours after vaccines. Swelling and redness at its peak at 48h after vaccines. Malaise started upon waking the morning after vaccine. Spreading of swelling and redness stopped after 48 hours. Parents treated with BENADRYL cream and TYLENOL.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Decreased appetite, Dizziness, Fatigue, Tremor
Clinical narrative: 3rd HPV given on 2/1/17, previously healthy. Returned on 3-2-17 with fatigue and dizziness. Seen on 3/7/17 with fatigue, dizziness, decreased appetite. 3-15-17 symptoms increased, exhaustion. 3/24/17 dizzy, tired, hyperacusia, legs shaking.