chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Swelling on right deltoid and warm to touch.
Age: 50.0
Sex: F
Vaccine: MMR
Symptoms: Dysgeusia, Immediate post-injection reaction, Injection site pain, Palpitations, Tremor
Clinical narrative: During injection - site pain. Immediately after injection - metallic taste/hands shaking (visually observed)/heart racing.
Age: 0.42
Sex: M
Vaccine: DTAP
Symptoms: Crying, Developmental delay, Irritability, Middle insomnia, Regressive behaviour
Clinical narrative: DTaP administered on 7/20/16. Beginning that night patient was fussy, waking up and crying frequently. For the next 5 wks, he woke almost hourly at night crying. After the vaccine he stopped "babbling and singing" vocalization and did not advance developmentally. SXs improved during the last week.
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Chills, Decreased appetite, Dizziness, Dysstasia, Fatigue
Clinical narrative: Hard time standing extremely lightheaded. Felt like he was going to pass out. Slight fever very very fatigued, decreased appetite. 1 hour after shot (24 degree). Wed A.M. rash at site. Extreme fatigue, extended lightheaded, chills.
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Pyrexia
Clinical narrative: Hard time standing extremely lightheaded. Felt like he was going to pass out. Slight fever very very fatigued, decreased appetite. 1 hour after shot (24 degree). Wed A.M. rash at site. Extreme fatigue, extended lightheaded, chills.
Age: 18.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Disorientation, Loss of consciousness, Seizure, Syncope
Clinical narrative: patient fainted/lost consciousness and started to convulse 1-2 minutes after injection for about 1-2 minute pt was disoriented when regain consciousness.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Pyrexia
Clinical narrative: Mom called to report fever of 106 last night (9-1-2016) at 1130pm. Fever this morning of 102 (9-2-2016) MOTRIN given at 830am. Appointment scheduled with physician 9/2/2016 1045am. Temp 98.2 at 11am at physician appointment.
Age: 66.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injection site pain, Injection site swelling, Nausea
Clinical narrative: Patient called pharmacy and reported pain and swelling at injection site the day after receiving injection. Also mentioned a little nausea. Told patient to take acetaminophen and ice the painful area.
Age: 66.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient called pharmacy and reported pain and swelling at injection site the day after receiving injection. Also mentioned a little nausea. Told patient to take acetaminophen and ice the painful area.
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Varicella
Clinical narrative: Varicella Rash X 3days symptomatic care.
Age: 44.0
Sex: F
Vaccine: TD
Symptoms: Fluid retention, Joint swelling, Lethargy, Peripheral swelling, Thirst
Clinical narrative: Water retention; swelling to ankles and hands; lethargy; thirst.
Age: 63.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness, swelling, tender right triceps area.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Redness at injection site. Noticed few days after injection. Redness seems to be getting lighter, but spreading. About 2 1/2 inch in size.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Induration, Injection site erythema, Injection site mass, Injection site rash, Skin reaction
Clinical narrative: 8/18/16 5:42 PM Patient called to say area was red (about the size of a lemon) and hard in the center, no fever - told her to apply ice, take ibuprofen and BENADRYL if itchy. Told her to call pharmacy if area doesn't start to get smaller or looks worse. May need to call MD if worse. 8/19/16 pm Patient came to pharmacy - entire upper part of arm is bright pink, there was darker red, raised bumpy area around injection site. Said she could feel a lump under skin. Patient told to see a doctor/urgent care/ER. 8/23/16 10:40 Am patient self treated. She said she's better - redness is gone, hardness gone, has brown spot remaining where it was large area of pink
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Mom called office - stated child had some redness, swelling and itchiness at (R) deltoid site from 2 shots. She was advised to do BENADRYL and cold compress to site, mark with a circle rxn area, if no better or increased in redness to call us back.
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis at site of injection.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Swelling, warm at injection site. Left deltoid. Given BENADRYL and Ibuprofen.
Age: 2.0
Sex: F
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Contracted Varicella after 2 vac / symptomatic care.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with a dose of improperly stored VARIVAX (lot # M010480, expiry date: 01-MAR-2018) (route: subcutaneous) (incorrect product storage). The vaccine was stored at a temperature of 49 F for 2 hours and 30 minutes. There was no previous temperature excursion. Data logger was involved. No adverse effects reported. The outcome of the events was unknown. Additional information is not expected.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis
Clinical narrative: Cellulitis to arm. Prescribed amoxicillin.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patients of unknown age and gender. There was no information about the patient's current condition, concomitant therapies or medical history provided. On 11-AUG-2016, the patient was vaccinated with an improperly stored dose of VARIVAX lot # M009768 with an expiration date: 23-FEB-2018 (dose, frequency and route of administration were not reported). Administered dose of VARIVAX experienced temperature excursion of 13 degree Fahrenheit for 90 minutes, on an unknown date. There was no previous temperature excursion. Digital data logger was not involved. No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Hypotonia, Pallor
Clinical narrative: Parents reported to us today (9-2-16) that their baby experienced about a 10 minute period of "being pale and limp" app. 30 mins after his 2 mos. vaccines. Resolved on its own.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to multiple unspecified patients of unknown gender and age. Information regarding the patients' medical history, concurrent conditions, drug reactions/allergies and concomitant therapy were not provided. On unknown dates, these patients were vaccinated with doses of improperly stored ROTATEQ (lot # L037921, expiry date: 31-MAY-2017). Medical assistant reported that the vaccines went to 31.8 F for 7 hours and 45 minutes. They were logged by a data logger and there were no prior excursions. The vaccines were back in range. No adverse effects were reported. This is one five reports received from the same reported. Additional information has been requested.
Age: 81.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered, Herpes zoster
Clinical narrative: This spontaneous report was received from the patient's wife concerning her 81 years old husband. The patient's concurrent conditions, medical history and concomitant medications were not provided. In approximately 2008 (reported as "about 6 years ago"), the patient was vaccinated with the first dose of ZOSTAVAX (lot #, dose and route were not provided). The reporter said that the patient then got a "booster" (second shot of the singles) few years later (on an unspecified date) (lot #, expiration date, dose and route were not provided). The reporter stated that her husband developed shingles a week ago (or approximately 12-AUG-2016), (unspecified location)l. The patient sought medical attention since he went to the doctor and was prescribed penicillin 3 times a day. It was also mentioned that "now" he had shingles in his head and nose. PQC was not involved. At the time of the reporting, the outcome of shingles was reported as not recovered. Additional information is not expected since the reporter did not give a permission to contact his physician.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to multiple unspecified patients of unknown age and gender. Information regarding relevant medical history, concurrent condition and concomitant medications were not reported. On multiple unspecified dates, the patients were vaccinated with improperly stored VARIVAX (lot # M000998 with expiration date 07-JAN-2018, lot # M006156 with expiration date 05-FEB-2018, lot # M010482 with expiration date 01-MAR-2018, lot # M009765 with expiration date 23-FEB-2018, lot # M019643 with expiration date 20-APR-2018, dose and route not reported). No adverse effects were reported. The patients would continue vaccination with VARIVAX. This is one of two reports received from the same source. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: This spontaneous report was received from a 60 year old male patient, who was reporting on himself. The patient did not have any pertinent medical history, drug reactions or allergies. On 17-AUG-2016 (reported as 2 days ago), the patient was vaccinated with a dose of ZOSTAVAX, one injection, subcutaneously (site of administration, lot number and expiration date were not reported). Concomitant therapies included famciclovir and lisinopril (manufacturer unknown). On 19-AUG-2016, the patient had red, puffy and itchy skin at injection site. He did not seek medical attention. No lab diagnostic studies were performed and no treatment was given for the events. Product quality complaint was not involved. The outcome of the events was considered to be not recovered (reported as "still there"). The relatedness between the events and vaccination with ZOSTAVAX was not reported. No other information was provided. Additional information is not expected as no consent for contact was provided.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to multiple unspecified patients of unknown age and gender. Information regarding relevant medical history, concurrent condition and concomitant medications were not reported. On multiple unspecified dates, the patients were vaccinated with improperly stored PROQUAD (lot # M009745 with expiration date 23-AUG-2017, lot # M014302 with expiration date 22-SEP-2017, lot # reported as M012053 with expiration date 11-JUL-2017, lot # M004894 with expiration date 26-JUL-2017, subcutaneous, dose not reported. No adverse effects were reported. The patients would continue vaccination with PROQUAD. This is one of two reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Seizure
Clinical narrative: This spontaneous non-valid report as received from a consumer refers to an unknown number of patients of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. The consumer reported about another parent's children who riddled with seizures after vaccination with GARDASIL (captured in MARRS# 1608USA012924). After that, the reporter did some research in the internet and found similar stories online. On an unknown date, the patients were vaccinated with GARDASIL (strength, dose, frequency, route of administration, lot # and expiration date were not reported). On an unknown date, the patients experienced seizure. The outcome of seizure was unknown. The relatedness between vaccination with GARDASIL and the event was not reported. Upon internal review the event of seizure was considered to be medically significant. This is one of 2 reports from the same reporter. Additional information is not expected.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to 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 received improperly stored dose of ROTATEQ (lot # L029615, expiration date: 15-MAY-2017) orally (dose was not reported). The administered dose of vaccine was exposed to a temperature of 33.3 Fahrenheit degrees for 24 hours. No previous temperature excursions were reported. The reporter provided, that data logger was used. No adverse effect was reported. No product quality complaint (PQC) was involved. This is one of two reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a multiple patients of unknown age and gender. The patients' pertinent medical history and drug reactions and allergies were not reported. On an unknown dates, the patients were vaccinated with an improperly stored GARDASIL 9 (lot # reported as M020103, expiration date reported as 30-AUG-2017, dose and frequency were not reported) intramuscularly. Concomitant therapy was not reported. No adverse effects were reported. There was no Product Quality Complaint (PQC). Lot number M020103 is an  invalid lot number for GARDASIL 9. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapy were not reported. On 16-AUG-2016, the patient was inadvertently vaccinated with an improperly stored dose of ZOSTAVAX (dose and route were not reported, lot # M018593, expiration date 28-JUN-2017). The vaccine was exposed to a temperature of 20 Fahrenheit degrees for 11 hours. Data logger was not used. There was no previous temperature excursion. No adverse effect was reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to an unspecified number of patients of unknown age and gender,. Information regarding concomitant medication, medical history and drug reactions/allergies was not reported. On unknown dates, the patients were vaccinated with improperly stored does of PROQUAD (rHA) (lot # M011662 with expiration date 08-SEP-2017, dose unknown, subcutaneous. The vaccine was improperly stored at 40.1 degree Fahrenheit for 50.5 hours. Data logger was involved. There was no prior excursion. No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information was received from a registered medical assistant referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On an unknown date between 08-AUG-2016 and 11-AUG-2016, the patient received unspecified dose of improperly stored VARIVAX injection (lot# L049533, expired date 08-DEC-2017) (dose, frequency and route unknown). The vaccine was previously exposed under -3.48 Celsius degree for 1 minute on 08-AUG-2016, and currently exposed under -14.16 Celsius degree for 2 hours 45 minutes. Digital data logger was involved. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to an unspecified number of patients of unknown age and gender. Information regarding concomitant medication, medical history and drug reactions/allergies was not reported. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX (lot #L044525 with expiration date 09-NOV-2017, dose and route were not reported). The vaccine was improperly stored at 40.1 degree Fahrenheit for 50.5 hours. Data logger was involved. There was no prior excursion. No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to multiple unspecified patients of unknown gender and age. Information regarding the patients' medical history, concurrent conditions, drug reactions/allergies and concomitant therapy were not provided. On unknown dates, these patients were vaccinated with doses of improperly stored GARDASIL 9 (lot # L020015, expiry date: 16-AUG-2017). Medical assistant reported that the vaccines went to 31.8 F for 7 hours and 45 minutes. They were logged by a data logger and there were no prior excursions. The vaccines were back in range. No adverse effects were reported. This is one of five reports received from the same reporter. Additional information has been requested.
Sex: M
Vaccine: HIBV, PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to an unspecified number of patients of unknown age and gender. The patients' pertinent medication, drug reactions/allergies and concomitant medication were not reported. Between late June 2016 and 12-AUG-2016, the patients were vaccinated with doses of PNEUMOVAX 23 (lot # L022795 with 05-NOV-2016; dose and route were not reported), which were improperly stored (Excursion details: Time/Temperature: 9 degree Centigrade for 1 hour; Previous excursion: Yes, 12 degree Centigrade for 2.5 hours). No adverse effects were reported. This is one of several cases from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a certified medical assistant referring to unspecified patients of unknown age and gender. On unknown dates, the patients received doses of improperly stored M-M-R II (batch/lot number #K012473, expiration date 26-AUG-2016, batch/lot number #L032182, expiration date 25-AUG-2017, batch/lot number #L041456, expiration date 22-OCT-2017, dose and route not provided). No adverse reactions were reported. There was no product quality issue (PQC) involved. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant regarding multiple unspecified patients of unknown age and gender. Pertinent medical histories, drug reactions or allergies and concomitant therapies were not provided. On an unknown date, the patients were vaccinated with improperly stored doses of GARDASIL (lot # K009482, expiration date: 06-MAR-2017; lot # M014929, expiry date 27-MAY-2017) (exact dose and frequency unknown). No adverse effects were reported. There was no product quality complaint (PQC) involved. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site mass
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 64 years old male patient. The patient's medical history was not reported. The patient's concurrent conditions included allergy to cephalosporins, codeine and morphine derivatives, meperidine, naloxone, penicillins,  propoxyphene, methadone, opium alkaloids. On 16-AUG-2016, the patient was vaccinated with ZOSTAVAX, subcutaneously. Concomitant therapies included atorvastatin, bupropion, hydrochloride, mirtazepine,  es citalopram and diazepam. On an unknown date in August 2016, the patient developed a red, hard lump at the injection site following the administration of ZOSTAVAX. The patient was also vaccinated with an unspecified flu vaccine (manufacturer unknown) at the same time he received ZOSTAVAX. The patient received ZOSTAVAX in the opposite arm as the flu vaccine. The outcome of the events was report4d as not recovered. The causality of the events was not reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to multiple unspecified patients of unknown gender and age. Information regarding the patients' medical history, concurrent conditions, drug reactions/allergies and concomitant therapy were not provided. On unknown dates, these patients were vaccinated with doses of improperly stored RECOMBIVAX HB (lot # L019298, expiry date: 22-JUN-2017). Medical assistant reporter that the vaccines went to 31.8 F for 7 hours and 45 minutes. They were logged by a data logger and there were no prior excursions. The vaccines were back in range. No adverse effects were reported. This is one of five reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to multiple unspecified patients of unknown gender and age. Information regarding the patient's medical history, concurrent conditions, drug reactions/allergies and concomitant therapy were not provided. On unknown dates, these patients were vaccinated with doses of improperly stored GARDASIL (lot # K007828, expiry date: 02-MAR-2017). Medical assistant reported that the vaccines went to 31.8 F for 7 hours and 45 minutes. They were logged by a data logger and there were no prior excursions. the vaccines were back in range. No adverse effects were reported. This is one of five reports received form the same reporter. 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 medical assistant refers to multiple unspecified patients of unknown gender and age. Information regarding the patients' medical history, concurrent conditions, drug reactions/allergies and concomitant therapy were not provided. On unknown dates, these patients were vaccinated with doses of improperly stored VAQTA (lot # K019560, expiry date: 12-JUN-2017). Medical assistant reported that the vaccines went to  31.8 F for 7 hours and 45 minutes. They were logged by a data logger and there were no prior excursions. The vaccines were back in range. No adverse effect were reported. This is one of five reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician referring to an unknown number of patients of unknown age and gender. Information regarding concomitant medication, medical history and drug reactions/allergies was not reported. On unknown dates, on or after 01-APR-2016, the patient were vaccinated with improperly stored doses OF PROQUAD (lot # L031603 with expiration date 18-FEB-2017, therapy type rHA; lot # M007965 with expiration date 15-AUG-2017, therapy type rHA; dose and route were not reported). It was reported that the vaccine was improperly stored at 35.47 Fahrenheit for 314 hours and 15 minutes. There was no previous excursion. Data logger was involved. No adverse effect was reported. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician referring to an unknown number of patients of unknown age and gender. Information regarding concomitant medication, medical history and drug reactions/allergies was not reported. On unknown dates, on or after 01-APR-2016, the patient were vaccinated with improperly stores doses of VARIVAX (lot # L024253 with expiration date 01-JUL-2017, lot # L024256 with expiration date 01-JUL-2017, lot # L001328 with expiration date 13-JAN-2017, lot # L016123 with expiration date 06-MAY-2017; dose and route were not reported). It was reported that the vaccine was improperly stored at 35.47 Fahrenheit for 314 hours and 15 minutes. There was no previous excursion and data logger was involved. No adverse effect was reported. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions or allergies were not reported. On 24-AUG-2016, the patient was inadvertently vaccinated with an expired dose of ROTATEQ (lot # K022992, expiration date 30-JUN-2016, orally, dose was not reported). Concomitant therapy was not reported. No adverse effect was reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Age: 46.0
Sex: F
Vaccine: PPV
Symptoms: Chest pain, Flushing, Muscular weakness, Pain in extremity
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 46 year old non-pregnant female patient. The patient's concurrent conditions included asthma and chronic lung disease. The patient did not have any drug reactions or allergies and did not take any concomitant medications. On 14-AUG-2016, the patient was vaccinated with a dose of PNEUMOVAX 23 injection intramuscularly in unspecified arm, lot # L019836, expiration date 24-MAR-2017 (dose was not reported). On 14-AUG-2016, with a few seconds after receiving the dose, the patient experienced burning sensation through the middle of the chest and she felt flushed. Then, on the same day, about 3 hours after receiving the dose of PNEUMOVAX 23, the patient's whole arm, which was injected, felt weak and sore. The patient sought medical attention as she called the pharmacist. It was unknown if any lab diagnostic studies were performed. No treatment was given for the events. Product quality complaint was not involved. The patient recovered from burning sensation through the middle of the chest and feeling flushed on 14-AUG-2016, within a few minutes. The outcome of whole injected arm feeling weak and sore was unknown. The relatedness between all the events and vaccination with PNEUMOVAX 23 was not reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: Information has been received from a medical assistant concerning a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medication were not reported. On 12-JUN-2015, the patient was vaccinated with the first doses of GARDASIL (dose, route, lot # and expiration date were unknown). On 20-JUN-2016, the patient was vaccinated with GARDASIL 9 (lot # L036245, expiration date on 09-FEB-2018), 0.5 ml, intramuscular as the second dose, in the vaccination series. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to an unspecified number of patients of unknown gender and age. Information regarding the patients' medical history, concurrent conditions, drug reactions/allergies and concomitant therapy were not provided. On unknown dates, the patients were vaccinated with an improperly stored dose of GARDASIL (lot #M014929, expiry date: 27-MAY-2017) (incorrect product storage). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to unspecified number of patients of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. Since 11-MAY-2016, the patients were vaccinated with the improperly stored doses of GARDASIL (lot #, expiration date, dose and route were not reported). No adverse effects were reported. GARDASIL was supported until the labeled expiry. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: M
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to an unspecified number of patients of unknown age and gender. The patients' pertinent medication, drug reactions/allergies and concomitant medication were not reported. Between late June 2016 and 12-AUG-2016, the patients were vaccinated with doses of PEDVAXHIB (lot # M001814 with expiration date 15-OCT-2018; dose and route were not reported), which were improperly stored (Excursion details: Time/Temperature: 9 degree centigrade for 1 hour; Previous excursion: Y, 12 degree centigrade for 2.5 hours). No adverse effects were reported. This is one of several cases from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a physician referring to an unspecified number of patients of unknown ages and genders. The patients' concurrent conditions and medical histories were not reported. On unknown dates the patients were vaccinated with improperly stored doses of GARDASIL 9 (Lot # M004116, expiration date 12-OCT-2017) dose, route and anatomical location were unknown. There was no concomitant medication reported. The vaccines experienced the following temperature excursions on unknown dates: 29 F for 21 days. Reportedly, there had been no previous temperature excursions and the aforementioned ones were not identified due to a data logger. It was reported that GARDASIL 9 was not supported, the product was not suitable for use. This is one of several cases received from the same source. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a physician referring to an unspecified number of patients of unknown ages and genders. The patient's concurrent conditions and medical histories were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of PEDIVAXHIB (lot # J016188, expiration date 02-OCT-2016), dose, route and anatomical location were unknown. There was no concomitant medication reported. The vaccines experienced the following temperature excursions on unknown dates: 29 F for 21 days. Reportedly, there had been no previous temperature excursions and the aforementioned ones were not identified due to a data logger. It was reported that PEDVAXHIB was not supported, the product was not suitable for use. This is one of three cases received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a pharmacist (Pharm. D.) concerning a patient of unknown age and gender. No pertinent medical history, drug reactions, allergies or concurrent conditions were reported. On 30-AUG-2016, the patient was inadvertently vaccinated with an unspecified expired dose of PNEUMOVAX 23 (lot number L002310 with expiration date of 08-JUL-2016 (strength, dose, route of administration and anatomical location were not reported). Other suspect and concomitant medications were not provided. No adverse effects were reported. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product quality issue
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse referring to a patient of unknown age and gender. Pertinent medical history, concurrent conditions and concomitant therapies were not reported. The reporter stated that the patient received the third dose of GARDASIL 9 earlier than the recommended dosing schedule; as the patient received the first dose on 08-APR-2016, the second dose on 24-JUN-2016 and the third dose on 31-AUG-2016 (lot # M009378 and expiration date 23-APR-2018). (The doses, route, anatomical location and lot# of the first two doses were not reported). No adverse effects were reported and a product quality complaint was not involved. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a nurse regarding multiple unspecified patients of unknown age and gender. No concurrent conditions, medical history and concomitant medications were reported. On multiple unspecified dates, the multiple unspecified patients were inadvertently vaccinated with improperly stored doses of VARIVAX (lot # M005971 and expiry date: 02-FEB-2018 or lot: M009766 and expiry date: 23-FEB-2018) (dose, frequency and route of administration is not reported for the both lots). The vaccine was exposed to temperature of 29.3 Fahrenheit for 5 hours 24 minutes. No previous temperature excursion was reported and data logger was reported as yes. No product quality complaint (PQC) reported. Additional information has been requested.
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Headache, Malaise, Pain, Pyrexia
Clinical narrative: She says she developed 102.0 fever, aches, headache and chills on Saturday 6/4. She says she was sick for a week.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Unevaluable event
Clinical narrative: Started last night 8/31/16.
Age: 57.0
Sex: F
Vaccine: TDAP
Symptoms: Fatigue, Headache, Pain
Clinical narrative: "Very very tired." Headache, body aches. Symptoms began later in the same evening of the day she received TDAP. Fatigue lasted about 5 days.
Age: 17.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Activities of daily living impaired, Injected limb mobility decreased, Pain in extremity, Sleep disorder, Vaccination site pain
Clinical narrative: Area (left upper arm) where vaccine was administered was very swollen and tender to touch.  Patient was unable to lift arm due to the pain.  Put ice on the area and took advil.  Was unable to sleep comfortably due to the pain in arm; on 09/02/2016 the area was still swollen and was difficult for patient to lift arm to get tops on and off.  09/03/2016 the area was no longer swollen and able to lift arm, however still tender to touch.
Age: 17.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Vaccination site swelling
Clinical narrative: Area (left upper arm) where vaccine was administered was very swollen and tender to touch.  Patient was unable to lift arm due to the pain.  Put ice on the area and took advil.  Was unable to sleep comfortably due to the pain in arm; on 09/02/2016 the area was still swollen and was difficult for patient to lift arm to get tops on and off.  09/03/2016 the area was no longer swollen and able to lift arm, however still tender to touch.
Age: 17.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Erythema, Induration, Mobility decreased, Peripheral swelling
Clinical narrative: Area (left upper arm) where vaccine was administered was very swollen and tender to touch.  Patient was unable to lift arm due to the pain.  Put ice on the area and took advil.  Was unable to sleep comfortably due to the pain in arm; on 09/02/2016 the area was still swollen and was difficult for patient to lift arm to get tops on and off.  09/03/2016 the area was no longer swollen and able to lift arm, however still tender to touch.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site swelling
Clinical narrative: Patient reported swelling at site of injection the occurred on 9-2-16. When she woke up on the morning of 9-3-16, the swelling had spread significantly to include area between shoulder and elbow. Does not report excessive pain.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site swelling
Clinical narrative: Patient reported swelling at injection site that extended to the elbow. By the patient's account, the swelling had significantly decreased by the morning of 9-3-2016.  No other symptoms reported.
Age: 29.0
Sex: M
Vaccine: TDAP
Symptoms: Pyrexia, Rash
Clinical narrative: High fever per one day and rash in the trunk and both arms.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Abasia, Angiogram, Computerised tomogram, Echocardiogram, Laboratory test
Clinical narrative: Weakness and heaviness in her right hand; 30 minutes later it went up her right arm and down her right leg.  She couldn't walk and needed to be escorted by her step-father to the car.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Limb discomfort, Mobility decreased, Muscular weakness, Nuclear magnetic resonance imaging, Ultrasound scan
Clinical narrative: Weakness and heaviness in her right hand; 30 minutes later it went up her right arm and down her right leg.  She couldn't walk and needed to be escorted by her step-father to the car.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Eye discharge, Eye pruritus, Fatigue, Headache
Clinical narrative: Red itchy eyes with mucus in them.  Eyes bloodshot.  Nausea, chills, throat appeared to swell and a sore throat. Urge to vomit and did.  Very tired and simply did not feel well.  Needed to sleep.  Pounding headache.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Malaise, Nausea, Ocular hyperaemia, Oropharyngeal pain, Pharyngeal oedema
Clinical narrative: Red itchy eyes with mucus in them.  Eyes bloodshot.  Nausea, chills, throat appeared to swell and a sore throat. Urge to vomit and did.  Very tired and simply did not feel well.  Needed to sleep.  Pounding headache.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Somnolence, Vomiting
Clinical narrative: Red itchy eyes with mucus in them.  Eyes bloodshot.  Nausea, chills, throat appeared to swell and a sore throat. Urge to vomit and did.  Very tired and simply did not feel well.  Needed to sleep.  Pounding headache.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Patient said rash appeared over night and she woke up with it Tuesday morning.  She said it doubled in area by Wednesday. She went to doctors on 9/2/16 and the doctor wanted to try an antiviral to see if that would help.  Patient said the rash is not painful nor does it bother her.  It is mostly on her left side which is the side the vaccination was given.  She said the rash is minimum on her right side.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Headache, Nausea, Ocular hyperaemia, Swelling face
Clinical narrative: Patient reports that she had excruciating pain in the back of her head, face swelling that resolved the next day, dizziness, nausea, and redness in the eye without any pain or discomfort. She did not seek any medical attention or treat any of her symptoms.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Headache, Nausea
Clinical narrative: Nausea/Gastrointestinal distress, then severe headaches 4 days later. Patient took hydrocortisone 5mg tab daily as needed to treat headache.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Infection, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Awoke with very painful right arm (that received injection).  As the day went on, I developed a significant rash and my arm became red, swollen and very painful, ultimately almost from the shoulder all the way down to the elbow.   The rash was at its largest about 17-22 cm, with the infected area much larger.  The episode lasted approximately one full week, on antibiotics beginning on day 3.  The extent of the cellulitus infection was surprising to the doctors, as was the scope and vividness of the rash.  None had seen such a reaction before to this vaccine.  I have not ever reacted to other vaccines before.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Rash, Renal function test, White blood cell count
Clinical narrative: Awoke with very painful right arm (that received injection).  As the day went on, I developed a significant rash and my arm became red, swollen and very painful, ultimately almost from the shoulder all the way down to the elbow.   The rash was at its largest about 17-22 cm, with the infected area much larger.  The episode lasted approximately one full week, on antibiotics beginning on day 3.  The extent of the cellulitus infection was surprising to the doctors, as was the scope and vividness of the rash.  None had seen such a reaction before to this vaccine.  I have not ever reacted to other vaccines before.
Age: 87.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Swelling, redness, and pain at injection site.
Age: 63.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site reaction
Clinical narrative: Patient had injection site reaction, end up going to urgent care and got Antibiotics.
Age: 50.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Body temperature increased, Headache, Lethargy, Nausea, Pain in extremity
Clinical narrative: Day following vaccines at 1 pm patient was lethargic, nausea with a slight headache. Arm that received vaccination was painful and hot. She later vomited and had a temperature of 101.1 degree F. She had husband take her to ER.
Age: 50.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Skin warm, Vomiting
Clinical narrative: Day following vaccines at 1 pm patient was lethargic, nausea with a slight headache. Arm that received vaccination was painful and hot. She later vomited and had a temperature of 101.1 degree F. She had husband take her to ER.
Age: 83.0
Sex: F
Vaccine: FLU3, PPV, FLUX, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: Patient triceps area got swollen, redness, rashes and very painful. Recommended: Take Ibuprofen, diphenhydramine and iced the affected area. Also need to follow up with urgent care.
Age: 83.0
Sex: F
Vaccine: FLU3, PPV, FLUX, PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient triceps area got swollen, redness, rashes and very painful. Recommended: Take Ibuprofen, diphenhydramine and iced the affected area. Also need to follow up with urgent care.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site reaction, Rash erythematous
Clinical narrative: Patient has a red rash that has spread in size on his upper right arm he states that is where the immunization was given.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Axillary pain, Hyperhidrosis, Neck pain, Pyrexia
Clinical narrative: FEVER, SWEATING, PAIN IN NECK, PAIN UNDER ARM LEFT.
Age: 61.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site cellulitis, Injection site erythema, Injection site warmth
Clinical narrative: Erythema and warmth just distal to site of injection, c/w cellulitis.
Age: 43.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema
Clinical narrative: REDNESS AROUND INJECTION SITE.
Age: 18.0
Sex: F
Vaccine: VARCEL
Symptoms: Contusion, Erythema, Pruritus, Skin warm
Clinical narrative: 4.5 X 5 cm round area of erythema with warmth and a central area of bruising. Very itchy.
Age: 1.25
Sex: F
Vaccine: DTAP, PNC13
Symptoms: Vaccination site rash, Vaccination site swelling
Clinical narrative: Large swollen area on thigh where vaccines were administered. Small rash around area.
Age: 20.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Started with area at injection site soreness with dark red area aprox. an inch wide with lump. Around 4:30 it I went into the walkin clinic and it measured 3 inches by 3 1/2 inches wide with dark red area, severe pain, and hot. They prescribed clindamycin and to place cold pack, Benadryl, hydrocortisone oimtment. By morning the area grew to about 6 inches with the same symptoms. Went back into the walkin clinic but this time told to continue everything except use heat for 20 min. every 2 hours. This is now the 3rd of Sept at 7:15pm and the site has continued to increase in redness, swelling, heat, and pain. This may not be the final result of this reactions.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV9, MNQ
Symptoms: Injection site erythema, Injection site mass, Injection site swelling
Clinical narrative: This spontaneous report was received from a nurse and refers to a 12 year old female patient. No information concerning the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 08-JUL-2016, the patient received the first dose of GARDASIL ( 0. ml, subcutaneously (lot # M009362 and expiration 13-JUN-2018) in her right thigh. On the same day, she was given HAVRIX (lot#C9d2, expiration date: 05-MAY-2018) (dose, frequency and route of administration not provided) in her arm and MENVEO (lot# A15123, expiration date: 30-MAY-2017) (dose, frequency and route of administration not provided). On 11-AUG-2016, the patient was seen for a lump in the right thigh swelling and redness. the subject received treatment. Lump was still present but much smaller in size. No further information was given. the outcome of the events was unknown. the relatedness between the event and vaccinations was not provided. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site reaction
Clinical narrative: This spontaneous report as received from a pharmacist via a field representative refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with doses of PNEUMOVAX 23 (dose, route of administration, lot # and expiration date were not reported). On unknown dates, the patients experienced abnormally large injection site. The patients sought medical attention and received an unspecified treatment. The outcome of abnormally large injection site was unknown. The relatedness between the event and PNEUMOVAX 23 was not reported. 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 nurse regarding an unspecified patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On an unknown date in December 2015, the patient was vaccinated with 1st dose of GARDASIL 9 (dosing details not known) and then received the 2nd dose of vaccine in July 2016; this is outside the recommendations per the GARDASIL 9 prescribing information. No adverse effects reported. No Product Quality Complaint (PQC) involved. Additional information has been requested.