chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 56.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Abscess drainage, Local swelling, Pain, Purulent discharge
Clinical narrative: Pt had some localized swelling and pain in the area 6/25.  Increased over the following week.  Seen in clinic for continued pain.  Warm compresses and meloxicam (Mobic) recommended.  When pain worsened, pt returned to clinic for rule out hematoma vs abscess.  Surgical drainage of purulent material on 7/6/15.  Given 10 day course of antibiotics.
Age: 1.0
Sex: M
Vaccine: HEPA
Symptoms: Pyrexia
Clinical narrative: FEVER @ 102 4 DAYS AND RUNNING.
Age: 78.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Mobility decreased, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Severe pain radiating to the arm, stiffness, chills initially 3-4 hours after administration. Talked with patient 7/9/15 and states it isn't red or swollen this morning but still painful and stiff. Can't rotate or lift arm. Patient's condition is improving.
Age: 11.0
Sex: U
Vaccine: DTAP
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Nurse gave Dtap instead of Tdap. No reaction. GSK- called vaccine does not need to be repeated and will count for vaccine in MCIR.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Patient developed a quarter-sized red area around injection site. It then progressed to a 3 in by 4 inch red, warm, itchy area around the injection site, per patient. 1 week post-injection patient states it seems to be subsiding.
Sex: M
Vaccine: VARZOS
Symptoms: Guillain-Barre syndrome
Clinical narrative: Information has been received from a pharmacist via a company representative referring to a male patient of unknown age. Information about patient's concurrent conditions and medical history was not reported. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (lot#, dose, route not reported). Concomitant medications were not provided. The pharmacist mentioned that the patient's son/daughter reported to her that the patient developed Guillain Barre Syndrome on an unspecified date after receiving ZOSTAVAX. The outcome of the event was unknown. The causality was not provided. Upon internal review, Guillain Barre Syndrome was determined to be medically significant. Additional information is not expected since the reporting pharmacist did not want to be contacted.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus, Skin warm
Clinical narrative: 1-2" red, hot to touch, itchy area. Pt had applied BENADRYL which had helped and counseled to add hydrocortisone. No systemic effect.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Right arm swelling and redness (x3 days). Patient tried ice. Arm red and hot - swollen 11 x 17 cm.
Age: 0.54
Sex: F
Vaccine: DTAPHEPBIP, PNC13, RV5
Symptoms: Diet refusal, Mouth ulceration, Pyrexia
Clinical narrative: Oral ulcers. Refusal to eat & drink. Fever up to 104 degrees F.
Sex: U
Vaccine: PPV
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 medical history and current conditions were not provided. On 30-JUN-2015, the patient was vaccinated with a dose of improperly stored PNEUMOVAX 23 (lot #, expiration date, dose and route were not reported). No adverse effects were reported. Additional information has been requested.
Age: 65.0
Sex: U
Vaccine: PPV
Symptoms: Discomfort, Erythema, Swelling
Clinical narrative: Information has been received from a physician via Pfizer referring to a 65 years old patient of unknown gender. Medical history of the patient was not reported. In 2014 ("last year"), the patient was vaccinated with PNEUMOVAX 23 (lot#, route and dose not reported). It was reported the patient had swelling, redness and discomfort upon PNEUMOVAX 23 "last year" (in 2014). the outcome of the events was unknown. The reporter asked if it was recommended the patient should have a PREVNAR 13, or would that be a problem for adverse reaction. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Clinical Medical Assistant (C.M.A.) concerning unspecified patients of unknown demographics. The patients' medical history and drug reactions/allergies were not reported. On an unknown date, multiple unspecified patients were vaccinated with improperly stored (Oka/Merck) VARIVAX (dose, route, lot number and expiration date were unspecified). On 15-JUN-2015, the C.M.A reported that multiple different unspecified patients were administered (Oka/Merck) VARIVAX that were again stored improperly on unspecified date. No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to an unspecified number of patients of unknown age and gender. There were no concomitant medications, concurrent conditions and medical history reported. On an unknown date, the unspecified number of patients were vaccinated with RECOMBIVAX HB (dose, route of administration, lot# and expiration date not reported). The patients received a dose of RECOMBIVAX HB that was stored improperly. There was no adverse effects reported. Additional information is not expected. This is one of several reports received from the same reporter.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse, refers to patients of unknown demography. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, two patients were vaccinated with improperly stored (Oka/Merck) VARIVAX injection (lot # L011806, expiration date: 21-AUG-2016) (strength, dose and route unspecified). No concomitant medications were reported. No adverse effects were reported. The outcome of the event was unknown. There were no product quality complaint (PQC) involved. No further details were provided. This is one of several reports received from the same reporter. Additional information is not expected as the reporter did not wish further contact.
Sex: U
Vaccine: VARZOS
Symptoms: Ophthalmic herpes zoster, Uveitis
Clinical narrative: Information has been received from a physician via a health science consultant referring to unspecified number of patients of unknown age and gender. The concurrent condition included autoimmune disorder. The physician reported that he read in the following medical journals that there had been cases. The cases were reported as on an unknown date the patients were vaccinated with ZOSTAVAX (strength, dose, route, lot# and expiration date not provided), then developed zoster keratitis and uveitis. No concomitant medication reported. At the time of reporting, the outcome of adverse events was unknown. The causality between adverse events and ZOSTAVAX was not provided. Additional information is not expected as the reporter did not wish further contact.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site mass, Injection site rash
Clinical narrative: Information has been received from a pharmacist concerning a female patient of unknown age. Pertinent medical history or drug reactions/allergies were unknown. On 24-JUN-2015 the patient was vaccinated with a dose of ZOSTAVAX (0.65 ml, subcutaneous, lot number L006392). The reporting pharmacist could not confirm the expiration date for the vaccine. On 26-JU-2015, the patient experienced a rash and a lump at the injection site. The patient sought medical attention by calling the pharmacy. There was no treatment were given for the adverse events. At the time of reporting, the patient was not recovered from the adverse event. The causality was not provided. This is one of two reports received from the same reporter. Additional information has been requested. Lot number L006392 has been verified to be a valid lot number for ZOSTAVAX.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Information has been received from a pharmacist referring to a 52 year old female patient. The patient had no drug reactions/allergies. On 20-JUN-2015 the patient was vaccinated with a dose of ZOSTAVAX, lot # K009770, expiry date 09-OCT-2015, subcutaneously (dose was not reported). Information regarding concomitant medication was unspecified. On 21-JUN-2015, the patient developed an "area of redness wrapping around the arm around the site of ZOSTAVAX injection". The patient went to see the pharmacist and seek medical attention. No lab diagnostics studies were performed. On an unspecified date, the patient started CLARITIN and BENADRYL for the redness. The patient had not recovered. 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 Registered Nurse refers to an unspecified number of patients of unknown age and gender. There were no concomitant medications, concurrent conditions and medical history reported. On an unknown date, the unspecified number of patients were vaccinated with GARDASIL (dose, route of administration, lot # and expiration date not reported). The patients received a dose of GARDASIL that was stored improperly. There was no adverse effects reported. Additional information is not expected. This is one of several reports received from the same reporter.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous reprot was received from a nurse and refers to an unspecified number of patients of unknown age and gender. No information about patient's concomitant medication, pertinent medical history, drug reactions or allergies was provided. On an unspecified dates, an unspecified number of patients received improperly stored M-M-R II lot# J010601, exp. date 30-AUG-2015, lot# K024035, exp. date 26-NOV-2016, (dose, frequency and route of administration not reported). No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 02-JUL-2015 the patient was vaccinated with improperly stored RECOMBIVAX HB injection (lot # J004700, exp 26-NOV-2015, strength, dose and route unspecified). The reporter did not state if the administered RECOMBIVAX HB was the first dose in the series. No concomitant meddication was reported. No adverse symptoms reported. The outcome of the event was unknown. There were no product quality complaints (PQC) involved. This is one of several reports received from the same reporter. Aditional 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. On unknown dates the patients were vaccinated with doses of improperly stored (Oka/Merck) VARIVAX. No adverse experiences were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Licensed Practical Nurse referring to unspecified patients of unknown age and gender. the patients' concurrent and historical conditions were not reported. The nurse reported that doses of ROTATEQ (dose and frequency were not reported, oral, lot # K004432, expiration date 27-JAN-2016, lot # K014826, expiration date 28-MAY-2016 and lot # K017575, expiration date 01-JUN-2016) which were exposed to temperatures outside of the recommended range, had been administered to unspecified patients on unspecified dates since 18-JUN-2015. Concomitant therapies were not reported. No adverse effects had been reported. This is one of several reports 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 health professional (medical assistant) and refers to an unspecified number of patients of unknown age and sex. No pertinent medical history or concurrent conditions were reported. On an unknown date, the patients were vaccinated with improperly stored GARDASIL. No adverse effects reported. The outcome of incorrect product storage was unknown. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a health care professional refers to a patient of unknown age and gender. On 15-MAY-2015 the patient was vaccinated with improperly stored PROQUAD (Merck) (lot # K008868; expiry: 19-DEC-2015) (dose, route and frequency unspecified). No concomitant medications were reported. No adverse effects reported. There was no product quality complaint involved. The outcome of incorrect product storage was unknown. No further information provided. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. On 24-JUN-2015, the patient was vaccinated with improperly stored dose of ROTATEQ oral, lot # K011947, expiration date 07-JUN-2016. No adverse events were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. There were no concomitant medications, concurrent conditions and medical history reported. On an unknown date, the unspecified number of patients were vaccinated with ROTATEQ, orally (dose, lot# and expiration date not reported). The patients received a dose of oral, ROTATEQ that was stored improperly, exposed to 34.9F for 4 hours. There was no adverse effects reported. Additional information has been requested. This is one of several reports received from the same reporter.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. On 29-JUN-2015, the patient was vaccinated with improperly stored dose of ROTATEQ oral, lot # K011947, expiration date 07-JUN-2016. No adverse events were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. On 25-JUN-2015, the patient was vaccinated with improperly stored dose of ROTATEQ oral, lot # K011947, expiration date 07-JUN-2016. No adverse events were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a health care professional refers to a patient of unknown age and gender. On 05-MAY-2015 the patient was vaccinated with improperly stored PROQUAD (lot # K008868; expiry: 19-DEC-2015) (dose, route and frequency unspecified). No concomitant medications were reported. No adverse effects reported. There was no product quality complaint involved. The outcome of incorrect product storage was unknown. No further information provided. 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 as received from a healthcare worker refers to a patient of unknown age and gender. On 26-JUN-2015, the patient was vaccinated with improperly stored dose of GARDASIL lot #K011325, expiration date 08-APR-2017. No adverse events were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a health care professional refers to a patient of unknown age and gender. On 01-JUN-2015 the patient was vaccinated with improperly stored VARIVAX injection (lot # K018961: expiry: 15-OCT-2016 9dose, route and frequency unspecified). No concomitant medications were reported. No adverse effects reported. There was no product quality complaint involved. The outcome of incorrect product storage was unknown. No further information provided. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare professional refers to an unspecified number of patients. In approximately 2015 (reported as since 13-MAR-2015), the patients were vaccinated with doses of oral, ROTATEQ lot # K010221, K011663, K016313 and lot # reported as K015816 (expiration dates, dose, route and site of administrations were not reported) that were exposed to temperatures outside of the recommended range. No adverse effects had been observed or reported. Follow up information has been received from the medical assistant on 02-JUL-2015 regarding the patient of an unknown age and gender who on 02-JUN-2015 was vaccinated with a dose of oral, ROTATEQ (lot number K016313) (dose and route were not provided). There was 87 hours excursion. This lot number was received on 08-APR-2015. This is one of several reprots from the same reporter. Additional information is not expected as all correspondence was received.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a health care professional refers to a patient of unknown age and gender. On 06-MAY-2015 the patient was vaccinated with improperly stored (Oka/Merck) VARIVAX injection (lot # K018961; expiry: 15-OCT-2016) (dose, route and frequency unspecified). No concomitant medications were reported. No adverse effects reported. There was no product quality complaint involved. The outcome of incorrect product storage was unknown. No further information provided. This is one of several reports received from the same source. Additional information has been requested.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 64 year old male patient. No medical history and concurrent conditions were reported. On 22-JUN-2015, the patient was vaccinated with ZOSTAVAX (lot number: L006379 and expiry date: 25-MAY-2016) vial dose 0.65 milliliter (ml) once subcutaneous. No concomitant medications were reported. On 22-JUN-2015, the patient experienced redness and warmth at the injection site. No laboratory details were provided. The patient was not treated for the reported events and the patient sought for the medical attention and visited the pharmacist. The outcome of injection site erythema and injection site warmth was reported as not recovered. No further information available. No product quality complaint (PQC) was filed. The reported events were not considered as hospitalisation, cancer, life-threatening, disability or overdose. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a health care professional refers to a patient of unknown age and gender. On 05-MAY-2015 the patient was vaccinated with improperly stored PROQUAD (Merck) (lot # K008868; expiry: 19-DEC-2015) (dose, route and frequency unspecified). No concomitant medications were reported. No adverse effects reported. There was no product quality complaint involved. The outcome of incorrect product storage was unknown. No further information provided. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a health care professional refers to a patient of unknown age and gender. On 05-MAY-2015 the patient was vaccinated with improperly stored (Oka/Merck) VARIVAX injection (lot # K018961; expiry: 15-OCT-2016) (dose, route and frequency unspecified). No concomitant medications were reported. No adverse effects reported. There was no product quality complaint involved. The outcome of incorrect product storage was unknown. No further information provided. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare professional refers to an unspecified number of patients. In approximately 2015 (reported as since 13-MAR-2015), the patients were vaccinated with doses of ROTATEQ lot # K010221, K011663, K016313 and lot # reported as K015816 (expiration dates, dose, route and site of administrations were not reported) that were exposed to temperatures outside of the recommended range. No adverse effects had been observed or reported. Follow up information has been received from the reporting healthcare professional on 02-JUL-2015, who informed that a patient was vaccinated on 09-JUN-2015 with a dose of ROTATEQ lot # K016313, expiration date not reported, (administration route was not provided). According to the reporter the vaccine dose that was administered underwent a temperature excursion for 87 hours. This is one of several reports from the same reporter. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: This spontaneous report as received from a 63 year old female with Diabetes Mellitus reporting herself. In approximately 2013 (reported as two years ago), the patient was vaccinated with a one shingle shot of ZOSTAVAX (dose, route, lot number and expiry date were not reported). Concomitant therapies included metformin, INVOKANA and LANTUS. In approximately 2013 (reported as two years ago after I received ZOSTAVAX, the patient experienced a rash on her face. Recently (unspecified date), the consumer developed a rash on her legs and after seeking medical attention from an unspecified local physician she was diagnosed with shingles (herpes zoster). The patient received "balacyclovir" (dosage/frequency/manufacturer unknown) as a treatment. There was no laboratories diagnostics performed. The outcome of herpes zoster and rash was reported as not recovered. The relatedness between the events above mentioned and ZOSTAVAX was not provided. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. There were no concomitant medications, concurrent conditions and medical history reported. On an unknown date, the unspecified number of patients were vaccinated with GARDASIL (dose, route of administration, lot# and expiration date not reported). The patients received a dose of GARDASIL that was stored improperly, exposed to 34.9F for 4 hours. There was no adverse effects reported. Additional information has been requested. This is one of several reports received from the same reporter.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from the nurse and refers to a patient of unknown age and gender. No medical history and concurrent conditions were reported. On 20-JUN-2015, the patient was vaccinated with expired dose of 0.5 milliliter (ml) PNEUMOVAX 23 (lot # K009809 and expiry date: 16-MAY-2015) injection once through intramuscular route. No concomitant medications were reported. No adverse events were reported. The outcome of expired product administered was unknown. No product quality complaint (PQC) was filed. No further information available. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a health care professional refers to a patient of unknown age and gender. On 01-JUN-2015 the patient was vaccinated with improperly stored VARIVAX injection (lot # K018961; expiry: 15-OCT-2016) (dose, route and frequency unspecified). No concomitant medications were reported. No adverse effects reported. There was no product quality complaint involved. The outcome of incorrect product storage was unknown. No further information provided. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a health professional (medical assistant) and refers to an unspecified number of patient of unknown age and sex. No pertinent medical history or concurrent conditions were reported. On an unknown date, the patients were vaccinated with improperly stored ROTATEQ, via oral route. No adverse effects reported. The outcome of incorrect product storage was unknown. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant regarding 2 patients of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date, 2 patients were vaccinated with improperly stored (Oka/Merck) VARIVAX, lot number- L001331, expiration date1 13-JAN-2017 (dose strength, route was unknown). No concomitant medication was reported. No adverse event was reported. No product quality complaint (PQC) was involved. The outcome of the event was unknown. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. On 22-JUN-2015, the patient was vaccinated with improperly stored ROTATEQ oral, lot # K011947, expiration date 07-JUN-2016. No adverse events were reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 82.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: 82-yr old female (wt 66.2kg) came to clinic on 6/30/15 for follow-up.   Pneumococcal 13 vaccine 0.5ml IM was given at 0158 by CMA in right deltoid (# Wyeth-Ayerst Lot # L58152, expiration date 11/1/2016).  On 7/8/15, pt called the office to report that she experienced red, raised and itchy area over the right arm where she received the Prevnar injection on 6/30/2015.  Pt came to MD office at 1620 on 7/8/15 for assessment.
Age: 3.0
Sex: M
Vaccine: FLU4, PNC13
Symptoms: Expired product administered
Clinical narrative: Pt given expired dose of PCV Lot #G98915 Exp. 01/01/2015.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Acute myeloid leukaemia, Aspiration bone marrow abnormal, Chemotherapy, Fatigue, Nausea
Clinical narrative: Right arm pain x 3 weeks, which eventually radiated up to the Right side of the neck approximately 3 weeks after the vaccination.  Also developed nausea and fatigue approximately 6 weeks after vaccination.  Required ibuprofen to be able to move neck.  Diagnosed with AML on 12/2/2015.  2 days after start of chemotherapy, all symptoms resolved.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Neck pain, Pain in extremity
Clinical narrative: Right arm pain x 3 weeks, which eventually radiated up to the Right side of the neck approximately 3 weeks after the vaccination.  Also developed nausea and fatigue approximately 6 weeks after vaccination.  Required ibuprofen to be able to move neck.  Diagnosed with AML on 12/2/2015.  2 days after start of chemotherapy, all symptoms resolved.
Age: 3.0
Sex: M
Vaccine: HEPA, MMR, MNQ, TYP, VARCEL, YF
Symptoms: Anaphylactic reaction, Dyspnoea
Clinical narrative: Difficulty breathing. Went to Emergency Department.  Treated for anaphylaxis.
Age: 0.46
Sex: M
Vaccine: FLUN4, HIBV
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Invalid Dose of Flumist given- Vaccine for ages 2 and older, given to child 6 months.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Blister, Erythema, Rash, Rash erythematous, Rash maculo-papular
Clinical narrative: Affected locations: left buttock, left upper leg. The rash is characterized by blistering, redness and swelling. Maculopapular (red warm not oozing discrete edge to the rash confluent in the whole middle area of rash), pustular and vesicular (discrete groups of vesicles appears to follow dermatome but skipped directly under the diaper area).
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Rash pustular, Rash vesicular, Skin warm, Swelling, Varicella virus test positive
Clinical narrative: Affected locations: left buttock, left upper leg. The rash is characterized by blistering, redness and swelling. Maculopapular (red warm not oozing discrete edge to the rash confluent in the whole middle area of rash), pustular and vesicular (discrete groups of vesicles appears to follow dermatome but skipped directly under the diaper area).
Age: 12.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Crying, Hallucination, visual
Clinical narrative: HALLUCINATIONS INVOLVING SEEING A DARK MAN-SHAPED FIGURE, WITHOUT ARMS OR LEGS, CRAWLING ACROSS THE CEILING AND ATTACKING AND CHEWING ON HER TWIN SISTER. TERRIFIED OF WHAT SHE WAS SEEING, CRYING.  LASTED APPROXIMATELY 45-60 MINUTES PER FATHER.
Sex: M
Vaccine: HPV4
Symptoms: Neoplasm malignant
Clinical narrative: This spontaneous report as received from a registered nurse refers to a male patient of unknown age. On an unknown date, the patient was vaccinated with an unspecified number of doses of GARDASIL or GARDASIL 9 (dose, route and site of administration were not reported for both). On an unknown date, the patient was diagnosed with an unspecified cancer. The patient sought medical attention for diagnosis of cancer and an unspecified type of cancer treatment. The outcome of cancer was unknown. The relatedness between the event and GARDASIL or GARDASIL 9 was not reported. Upon internal review the event of unspecified cancer was considered to be medically significant. Additional information has been requested.
Age: 67.0
Sex: M
Vaccine: PNC13
Symptoms: Rash macular
Clinical narrative: Enlarged macular rash.
Age: 18.0
Sex: M
Vaccine: HPV9
Symptoms: Drug administered to patient of inappropriate age, Fatigue, Headache, Malaise
Clinical narrative: This spontaneous report was received from a physician via company representative refers to an 18 year old male patient. No pertinent medical history was reported. On 11-JUN-2015, the patient was vaccinated with first injection of GARDASIL 9. The next day on 12-JUN-2015, the patient felt tired, experienced symptoms of general malaise and headache. The patient sought medical attention. The patient had unspecified treatment by an unspecified infectious disease physician who recommended that he discontinue the GARDASIL 9 therapy. The patient was 18 years old which is outside the age range for indicated use of GARDASIL 9. No Product Quality Complaint (PQC) was involved. Action taken was not applicable. The outcome of events was unknown. The reporter did not provide the causality between the event and the suspect therapy. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to an unspecified number of patient of unknown age and gender. Patients' pertinent medical history or drug allergies were not reported. On unknown dates patient received improperly stored PEDVAXHIB (lot#, expiration date, strength, dose, frequency and route were unknown). The patients' concomitant medication was not reported. No adverse effects reported. This is one of several reports received from the same source. 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 health professional (medical assistant) and refers to an unspecified number of patient of unknown age and sex. No pertinent medical history or concurrent conditions were reported. On an unknown date, the patients were vaccinated with improperly stored VAQTA. No adverse effects were reported. The outcome of incorrect product storage was unknown. Additional information has been requested.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 71 year old male patient enrolled in a patient support program ZOSTAVAX pharmacy competitive qual exploration. The patient has current condition of cholesterol, high blood pressure and diabetes. On an unknown date in NOV-2014, the patient was vaccinated with ZOSTAVAX (lot # not reported). On an unknown date in 2014 (10 days after the vaccination) the patient developed herpes zoster. The outcome of the event was reported as recovered/resolved. The reporter considered the event to be not related to ZOSTAVAX. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to an unspecified number of patients of unknown age and gender. There were no concomitant medications, concurrent conditions and medical history reported. On an unknown date, the unspecified number of patients were vaccinated with ROTATEQ orally (dose, lot# and expiration date not reported). The patients received a dose of ROTATEQ that was stored improperly. There was no adverse effects reported. Additional information is not expected.
Age: 5.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a 5 year old patient of unknown gender. The patient's concurrent condition and medical history were not reported. On 24-JUN-2015 the patient was vaccinated with one dose of PROQUAD (lot# L002213, expiration date 21-JUL-2016, strength, dose and route were unknown) which was exposed to temperature conditions outside of the recommended range. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a nurse practitioner and refers to a patient of unknown age and gender. The patient's relevant medical history, concomitant medication and past drug history was unknown. On 30-JUN-2015 (reported as "on either 30-JUN-2015 or 01-JUL-2015"), the patient was administered (Oka/Merck) VARIVAX, 1 vaccine, lot # L002214, expiration date 21-JAN-2017 (dose, frequency and route of administration were not provided), for immunization, after it had a temperature excursion. That was unknown if there was any relevant laboratory data. At the time of reporting, it was unknown if the patient would ever get (Oka/Merck) VARIVAX again and the outcome of (Oka/Merck) VARIVAX being given after an excursion was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to an unspecified number of patients of unknown age and gender. Patients' pertinent medical history or drug allergies were not reported. On unknown dates patients received improperly stored GARDASIL 9 (lot#, expiration date, strength, dose, frequency and route were unknown). The patient's concomitant medication was not reported. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: FLUN4, TDAP
Symptoms: Metrorrhagia, Pain in extremity
Clinical narrative: Upon receiving the tetanus and pertussis injection, TB test and flu shot I noticed light spotting when I used the restroom. The spotting did not reoccur after that. It happened during a time when no spotting was supposed to occur. Shortly after I noticed that my left arm became sore. Since then my left arm hurts anytime I sleep on my left side and anytime I move it in a wide range of motions.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a nurse practitioner and refers to a patient of unknown age and gender. The patient's relevant medical history, concomitant medication and past drug history was unknown. On 30-JUN-2015 (reported as "on either 30-JUN-2015 or 01-JUL-2015"), the patient was administered VARIVAX (Merck), 1 vaccine, lot # L002214, expiration date 21-JAN-2017 (dose, frequency and route of administration were not provided), after it had a temperature excursion. That was unknown if there was any relevant laboratory data. At the time of reporting, it was unknown if the patient would ever get VARIVAX (Merck) again and the outcome of VARIVAX (Merck) being given after an excursion was unknown. This is one of several reports received form the same reporter. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Redness & swelling of left arm to elbow-area hot, was itching but no longer-patient is improving.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Injection site haematoma, Injection site swelling, Injection site warmth
Clinical narrative: Left upper arm hematoma-site of 1 injection below hematoma 12cm x 12cm circular raised swelling warm-had been increasing.
Age: 27.0
Sex: M
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, Incomplete course of vaccination, No adverse event
Clinical narrative: This spontaneous report was received from a 27 year old male consumer concerning himself. Pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On an unknown date the patient started the vaccine series of GARDASIL (doses, dose numbers, schedule, route, anatomical location, lot number and expiration date were unspecified). The reporter stated that he was unable to complete the GARDASIL series because he turned 27 last month. It was not confirmed if or when the patient began the GARDASIL therapy. No adverse event was reported. No concomitant therapies were reported. Additional information is not expected, no contact details were provided.
Age: 1.03
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Injection site rash, Injection site reaction, Scab
Clinical narrative: Rash with multiple crusted spots on (R) thigh near where vaccine given concerning for primary varicella.
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. On unknown dates the patients were vaccinated with doses of improperly stored PROQUAD (Merck). No adverse experiences were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a health care professional refers to a patient of unknown age and gender. On 05-MAY-2015 the patient was vaccinated with improperly stored VARIVAX (Merck) injection (lot # K018961; expiry: 15-OCT-2016) (dose, route and frequency unspecified). No concomitant medications were reported. No adverse effects reported. There was no product quality complaint involved. The outcome of incorrect product storage was unknown. No further information provided. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age. On 23-JUN-2015, the patient was vaccinated with PROQUAD (Merck) (dose, frequency and route were not reported) (lot # K025760 and expiry date: unknown) which was improperly stored. No adverse effects were reported. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a son's patient (physician) refers to his father of unknown age. Medical history and concurrent conditions were not provided. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (dose, route, lot number and expiry date were not reported). There was no concomitant medication provided. On an unknown date (two years after received ZOSTAVAX), the patient got shingles (herpes zoster). The patient sought medical attention. The outcome of herpes zoster was reported as recovered (unspecified date). The relatedness between the event above mentioned and ZOSTAVAX was not provided. Additional information is not expected because the reporter did not want to be contacted.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to 4 unspecified patients of unknown age and unknown gender. From 25-JUN-2015, the 4 patients were vaccinated with PROQUAD (Merck) (dose, frequency and route were not reported) (lot # K025760 and expiry date: unknown) which were improperly stored. No adverse effects were reported. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Immediate post-injection reaction, Presyncope, Vomiting
Clinical narrative: This spontaneous report was received from a health care professional refers to a 21 year old female patient. Pertinent medical history and drug allergies: None. On 03-JUN-2015 the patient was vaccinated with first dose of GARDASIL intramuscular injection (lot # K011562; expiry: 08-APR-2017) (dose unspecified). Concomitant medications was reported as none. On 03-JUN-2015, the patient experienced vomiting and vasovagal response in the office immediately after administration of the GARDASIL. The patient recovered approximately in June 2015. No further information was provided. Causality assessment was not 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. Patients' pertinent medical history or drug allergies were not reported. On unknown dates patients received improperly stored (Oka/Merck) VARIVAX (lot # K026385, expiration date 15-DEC-2016, lot # L001335, expiration date 13-JAN-2017, lot # L001327, expiration date 13-JAN-2017, lot# L006383, expiration date 25-FEB-2017, strength was unknown, 0.5 ml/once) subcutaneously. The patient's concomitant medication was not reported. No adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 02-JUL-2015 the patient was vaccinated with improperly stored RECOMBIAVX HB injection (lot # J004700, exp 26-NOV-2015, strength, dose and route unspecified). The reporter did not state if the administered RECOMBIVAX HB was the first dose in the series. No concomitant medication was reported. No adverse symptoms reported. The outcome of the event was unknown. There were no product quality complaints (PQC) involved. This is one of several reprots received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Licensed Practical Nurse referring to unspecified patients of unknown age and gender. The patient's concurrent and historical conditions were not reported. The nurse reported that doses of GARDASIL (dose, route and site of administration were not reported, lot # K006960, expiration date 19-FEB-2017 and lot # K016966, expiration date 10-MAY-2017) which were exposed to temperatures outside of the recommended range, had been administered to unspecified patients on unspecified dates since 18-JUN-2015. Concomitant therapies were not reported. No adverse effects had been reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous reprot was received from a health care professional refers to a patient of unknown age and gender. On 21-MAY-2015 the patient was vaccinated with improperly stored PROQUAD (Merck) (lot # K008868; expiry: 19-DEC-2015) (dose, route and frequency unspecified). No concomitant medications were reported. No adverse effects reported. There was no product quality complaint involved. The outcome of incorrect product storage was unknown. No further information provided. This is one of several reports received from the same source. 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. On unknown dates the patients were vaccinated with doses of improperly stored VARIVAX (Merck) (subcutaneous, 0.5 ml, once). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. On 25-JUN-2015, the patient was vaccinated with improperly stored dose of ROTATEQ oral, lot # K011947, expiration date 07-JUN-2016. No adverse events were reported. This is one of several reports received form the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a certified medical assistant referring to an unspecified number of patients of unknown age and unknown gender. Pertinent medical history and drug reactions/allergies were not reported. On an unknown date the patients received improperly stored ROTATEQ, (dose, lot# and expiration date were not reported) orally. Concomitant drug was not reported. No adverse effects reported. It was unknown wether the patients sought medical attention. Additional information has been requested.