chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 76.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Erythema, Injection site erythema, Injection site pruritus, Injection site swelling, Peripheral swelling
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 76 year old female patient with anal cancer and no known drug reactions or allergies. On 12-JAN-2015, the patient was vaccinated with a dose of PNEUMOVAX 23, lot # J013555, expiration date 02-MAY-2015, 0.5 ml, subcutaneous in the patient's left upper arm. There was no information on concomitant medications. On 14-JAN-2015, the patient experienced peripheral swelling, erythema and pruritus described as swelling, redness and itchiness on her left upper arm after receiving PNEUMOVAX 23. The registered nurse was requesting a lot # check on PNEUMOVAX 23. The nurse reported that on 15-JAN-2015, the patient was seen by the physician and also was given an unspecified amount of BENADRYL. There were no laboratory diagnostics studies performed. At the time of the report, the patient had not recovered. Additional information has been requested.
Age: 76.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Pruritus
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 76 year old female patient with anal cancer and no known drug reactions or allergies. On 12-JAN-2015, the patient was vaccinated with a dose of PNEUMOVAX 23, lot # J013555, expiration date 02-MAY-2015, 0.5 ml, subcutaneous in the patient's left upper arm. There was no information on concomitant medications. On 14-JAN-2015, the patient experienced peripheral swelling, erythema and pruritus described as swelling, redness and itchiness on her left upper arm after receiving PNEUMOVAX 23. The registered nurse was requesting a lot # check on PNEUMOVAX 23. The nurse reported that on 15-JAN-2015, the patient was seen by the physician and also was given an unspecified amount of BENADRYL. There were no laboratory diagnostics studies performed. At the time of the report, the patient had not recovered. Additional information has been requested.
Age: 54.0
Sex: F
Vaccine: VARZOS, PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report has been received from a medical assistant refers to a 54 year old female patient. On 19-JAN-2015 the patient was vaccinated with ZOSTAVAX (strength, dose, route and lot # not reported), lot # J012661, expiration date: 10-JAN-2015. No adverse effects reported. Additional information has been requested.
Age: 54.0
Sex: F
Vaccine: VARZOS, PPV
Symptoms: Injection site erythema, Injection site swelling, Peripheral swelling, Tenderness
Clinical narrative: This spontaneous report has been received from a medical assistant refers to a 54 year old female patient. On 19-JAN-2015 the patient was vaccinated with ZOSTAVAX (strength, dose, route and lot # not reported), lot # J012661, expiration date: 10-JAN-2015. No adverse effects reported. Additional information has been requested.
Age: 27.0
Sex: F
Vaccine: HPV4
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a nurse refers to a 27 year old female patient without pregnant. No current or historical conditions were reported. On 21-JAN-2015 the patient was vaccinated with an expired dose of 0.5 ml GARDASIL (lot # H010123, expiration date 16-JAN-2015), intramuscular which was potency supported. This was patient's first dose in the GARDASIL series. No adverse effects reported. The patient had not sought medical attention. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Diagnostic procedure, Hepatic enzyme increased, Injection site swelling, Nausea
Clinical narrative: Information has been received from a pharmacist on 20-JAN-2015 referring to a 64 year old female patient. On 21-OCT-2014 the patient was vaccinated with a dose of ZOSTAVAX (lot # K009770, expiration date 09-OCT-2015), 0.65 ml, subcutaneous. Concomitant therapies included LEXAPRO, XANAXA and VICODIN. On 23-OCT-2014 the patient began to experience swelling at the injection site and was assessed by an unspecified physician. The unspecified physician prescribed unspecified antibiotics to decrease swelling. On an unspecified date after starting the antibiotics, the patient began to experience nausea and right upper quadrant abdominal pain. Unspecified labs studies were completed on an unspecified date, after starting antibiotic therapy, which had shown that the patient's liver enzymes were elevated. Other unspecified diagnostic studies have been completed on unspecified dates. The outcome of the adverse events was reported as 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 medical assistant refers to an unspecified number of patients of unknown demographics. No concurrent conditions or medical history were provided. On an unknown dates, since 30-OCT-2014, those patients were vaccinated with doses of GARDASIL injection (strength, dose, route of administration, lot# and expiry date unspecified), that were exposed to a supported excursion. No concomitant medications were reported. No adverse effects were reported. This is one of several reports 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 medical assistant refers to an unspecified number of patients of unknown demographics. No concurrent conditions or medical history were provided. On an unknown dates, since 30-OCT-2014, those patients had been administered doses of ROTATEQ suspension, route of administration not reported, defaulted to oral (strength, dose, lot# and expiry date unspecified), that were exposed to a supported temperature excursion. No concomitant medications were reported. No adverse effects were reported. This is one of several reports 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 certified medical assistant concerning to an unspecified number of patients of unknown age and gender. No medical history or concurrent conditions were reported. On an unspecified date in January 2015, also reported a s 09-JAN-2015, an unspecified number of patients were vaccinated with VARIVAX (Merck), subcutaneously (dose, strength, frequency and lot number were not provided) which underwent supported temperature excursions. Co-suspect or concomitant therapies were not provided. No adverse effects were reported. This is one of several reports 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 certified medical assistant concerning to an unspecified number of patients of unknown age and gender. No medical history or concurrent conditions were reported. On an unspecified date in January 2015, also reported as since 09-JAN-2015, an unspecified number of patients were vaccinated with PROQUAD (Merck), subcutaneously (dose, strength, frequency and lot number were not provided) which underwent supported temperature excursions. Co-suspect or concomitant therapies were not provided. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV4, MNQ
Symptoms: Immediate post-injection reaction, Nausea, Presyncope, Seizure, Syncope
Clinical narrative: Immediate vagal reaction/syncope with convulsive activity/seizure. Lasted 1-2 minutes and stopped spontaneously. Subsequent nausea/vomiting. Treated in ED with ZOFRAN and REGLAN.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV4, MNQ
Symptoms: Vomiting
Clinical narrative: Immediate vagal reaction/syncope with convulsive activity/seizure. Lasted 1-2 minutes and stopped spontaneously. Subsequent nausea/vomiting. Treated in ED with ZOFRAN and REGLAN.
Age: 2.0
Sex: F
Vaccine: DTAPIPVHIB, HEP, MMR, VARCEL
Symptoms: Vaccination site swelling, Vaccination site warmth
Clinical narrative: 5 cm - swelling and heat at vaccine site. Rt thigh on site of PENTACEL.
Age: 63.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: This spontaneous report as received from a 63 year old male patient with rheumatoid arthritis and no drug reactions/allergies refers to himself. On 19-JAN-2015, the patient was vaccinated with a dose of PNEUMOVAX 23 (lot # K007825, Expiry Date: 13-JAN-2016) 0.5 ml (route was not reported). Concomitant therapies included HUMIRA, methotrexate (manufacturer unknown), hydroxychloroquine sulfate, CELBREX and TRAVATAN. On 19-JAN-2015, the patient experienced injection site redness and injection site soreness. No treatment was given for adverse events. No Lab diagnostics were performed. The patient did not seek medical attention. The outcome of the events was reported as recovered/resolved on 21-JAN-2015. The relatedness between the events and PNEUMOVAX 23 was not reported. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Polymerase chain reaction, Secondary transmission, Varicella virus test positive
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age whose child was vaccinated with VARIVAX (Merck). The patient was enrolled in a program with Merck vaccine strain. Reporter stated that he learned about the VZVIP program from a colleague. He explained that he had a sample that their lab found was positive for varicella zoster virus (onset date was not reported) and they were interested in strain identification through our program. On 29-MAY-2014 specimen (swab from vesicle) was obtained and on 12-JAN-2015 was sent to laboratory. On 13-JAN-2015 the specimen arrived to laboratory, VZV DNA amplified and the VZV strain identification showed wild type strain (final polymerase chain reaction (PCR) specimen result). He did not have any additional case information but stated that he would fill out the patient with additional information. It was also reported that secondary transmission occurred on unknown date. The outcome of the events was unknown. The relatedness between the events and vaccination with VARIVAX (Merck) was not reported. Additional information has been requested.
Age: 16.0
Sex: U
Vaccine: HPV4
Symptoms: Dyspnoea, Pulmonary function test normal, Spirometry normal
Clinical narrative: Patient c/o SOB, no: LOC, fainting, rash, other symptoms. Treated with 50mg BENADRYL PO as per Dr's orders, symptoms did not return. Peak Flow Test (Spirometry) WNL. Patient has history of asthma.
Age: 2.0
Sex: M
Vaccine: DTAP
Symptoms: Vomiting
Clinical narrative: Pt. vomited.
Age: 39.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy
Clinical narrative: This prospective pregnancy case was reported by a nurse and described the occurrence of vaccine exposure during pregnancy in a 39-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). On 3 March 2014, the subject received unspecified dose of BOOSTRIX (intramuscular, unknown injection site). Her last menstrual period was on an unspecified date and estimated date of delivery was on 25 May 2014. The subject was exposed to the vaccine during the 3rd trimester. At the time of reporting, the pregnancy was ongoing. Follow-up information received on 16 June 2014: Vaccines responsible physician was added as reported source. 15 September 2014 - No further information was provided; patient lost to follow-up. 01 October 2014 - No new information received.
Sex: U
Vaccine: DTAPHEPBIP
Symptoms: Expired product administered, No adverse event
Clinical narrative: This case was reported by a other health professional and described the occurrence of expired vaccine used in a 2-month-old unk patient who received PEDIARIX (batch number unknown, expiry date 23rd October 2014). On 13th November 2014, the patient received PEDIARIX (unknown). On an unknown date, an unknown time after receiving PEDIARIX, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown. Additional information: No adverse event was reported.
Age: 26.0
Sex: F
Vaccine: TDAP
Symptoms: Delivery, Exposure during pregnancy
Clinical narrative: This prospective pregnancy case was reported by a healthcare professional and described the occurrence of vaccine exposure during pregnancy in a 26-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). An ultrasound was performed on 26 November 2013. The Alpha-fetoprotein test was performed on 4 February 2014. The results were 51.3. On 13 May 2014, the subject received an unspecified dose of BOOSTRIX (intramuscular, administration site was unknown). The last menstrual period was not provided. The estimated date of delivery was 19 July 2014. The subject was exposed to the vaccine during 3rd trimester. At the time of reporting, the pregnancy was ongoing. Follow-up information received on 25 July 2014: Subject details were provided. Vaccine responsible physician details were provided. Additional information received on 03 October 2014: Additional event(s) included live birth. The outcome of vaccine exposure during pregnancy was unknown. The outcome(s) of the additional event(s) included live birth (unknown). The pregnancy resulted in a live neonate with no apparent congenital anomaly. After 39 weeks and 3 days, the subject gave birth to a female neonate via vaginal delivery. The neonate weighed 3155 grams (6lbs 15oz) at birth. APGAR scores were 8 and 9. It was unknown if the investigator considered the vaccine exposure during pregnancy and live birth to be related to dTpa vaccine.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy
Clinical narrative: This prospective pregnancy case was reported by a nurse and described the occurrence of vaccine exposure during pregnancy in a 33-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). This is subject's 1st pregnancy. On 14 April 2014, the subject received unspecified dose of BOOSTRIX (intramuscular, unknown injection site). Her last menstrual period was on 19 September 2013 and estimated date of delivery was on 26 June 2014. The subject was exposed to the vaccine during the 3rd trimester. At the time of reporting, the pregnancy was ongoing. Follow-up information received on 13 June 2014: Facility where vaccine was administered was provided. 15 September 2014 - No further information was provided; patient lost to follow-up. Additional information received on 01 October 2014: VAERS has been updated.
Age: 9.0
Sex: F
Vaccine: DTAP
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Redness in arm, swollen, hot to the touch.
Sex: U
Vaccine: PNC13
Symptoms: Inappropriate schedule of drug administration, Interchange of vaccine products, 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 concurrent conditions were not provided. In November 2014, the patient was vaccinated with a dose of PNEUMOVAX 23, intramuscular (lot # and expiration date were not provided). Other suspect therapies administered on 20-JAN-2015, included PREVNAR (lot # and expiration date were not provided). Concomitant information medication was not provided. On 20-JAN-2015, the patient experienced inappropriate schedule of drug administration and interchange of vaccine products which were described as the patient received PNEUMOVAX 23 in November 2014; the pharmacist also reported that the patient received a dose of PREVNAR on 20-JAN-2015. No adverse effect was reported. It was unknown if the patient sought medical attention. At the time of the report, the patient's status was unknown. Additional information has been requested.
Age: 30.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Pruritus
Clinical narrative: Itching/redness began 3 days after vaccine given and lasted for 5 days total.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Agitation, Chest pain, Dizziness, Feeling drunk, Tinnitus
Clinical narrative: Ringing in ears. Pain in chest. Feels like drunk. Agitated/aggravated. (saw 4 doctors). Still ringing in ear. No change after 3 month. Dizzy still, tinnitus?
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. On 29-DEC-2014, the patient was vaccinated with an improperly stored GARDASIL (lot # H020901, expiry date 05-JUL-2015) (dosing regimen, route and frequency unknown). No concomitant medications were reported. No adverse effect was reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. On 17-DEC-2014, the patient was vaccinated with an improperly stored GARDASIL (lot # H020901, expiry date 05-JUL-2015) (dosing regimen, route and frequency unknown). No concomitant medications were reported. No adverse effect was reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. On 23-DEC-2014, the patient was vaccinated with an improperly stored GARDASIL (lot # H020901, expiry date 05-JUL-2015) (dosing regimen, route and frequency unknown). No concomitant medications were reported. No adverse effect was reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. On 20-NOV-2014, the patient was vaccinated with an improperly stored GARDASIL (lot # H020901, expiry date 05-JUL-2015) (dosing regimen, route and frequency unknown). No concomitant medications were reported. No adverse effect was reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. On 22-DEC-2014, the patient was vaccinated with an improperly stored GARDASIL (lot # H020901, expiry date 05-JUL-2015) (dosing regimen, route and frequency unknown). No concomitant medications were reported. No adverse effect was reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified number of patients with unknown demographics. Patients medical history and current condition was not reported. On 23-DEC-2014 the patients were vaccinated with improperly stored doses of VAQTA (lot # J000366 and expiry date 22-AUG-2014) (unknown strength and dose). No adverse effects reported. The outcome of the event was unknown. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. On 03-DEC-2014, the patient was vaccinated with an improperly stored GARDASIL (lot # H020901, expiry date 05-JUL-2015) (dosing regimen, route and frequency unknown). No concomitant medications were reported. No adverse effect was reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. On 25-NOV-2014, the patient was vaccinated with an improperly stored GARDASIL (lot # H020901, expiry date 05-JUL-2015) (dosing regimen, route and frequency unknown). No concomitant medications were reported. No adverse effect was reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 42.0
Sex: M
Vaccine: TDAP
Symptoms: Abdominal pain upper, Pain, Pyrexia
Clinical narrative: Pt. had Tdap on 1/25/15 at 12 PM. Developed fever, body aches, epigastric pain. Treated at Urgent Care. Possible cold chain failure - "cooler not plugged in as per patient".
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender. Pertinent medical history, drug reactions or allergies were not reported. On an unknown date the patient was administered with an improperly stored dose of VAQTA (strength, dose, dose number, route, anatomical location, lot number and expiration date were unspecified). No concomitant therapies were reported. No adverse events were reported. The outcome of the events was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Fall, Head injury, Malaise
Clinical narrative: At 3:30 pm pt. was given HPV #1, pt was in the room for 5 min then went to the waiting area to make an appointment. Around 3:45 pt felt sick and fell to the floor where she hit her head. We notify the Dr. laid her down on the bed took the PB 116/63.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: This spontaneous report was received from a physician via a company representative refers to a male patient of unknown age. Concurrent conditions, medical history and allergies were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX, (dose, frequency, route, anatomical location, lot number and expiration date were not reported). Other suspect and concomitant therapies were not reported. On an unknown date, the patient experienced herpes zoster describe as "breakthrough" shingles and rash. The patient sought medical attention and saw Doctor. It was unspecified if treatment was given and if lab diagnostics studies were performed. The outcome of herpes zoster and rash was reported as recovered/resolved on an unknown date. The relatedness between the herpes zoster and rash, and therapy with ZOSTAVAX was not reported. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Itching and redness at injection site (within 15 minutes). Patient took BENADRYL at this resolved the itching.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth, Local reaction
Clinical narrative: Pt described her injection site as hot, red and about the size of an egg. Seems to be consistent w/ a localized injection site reaction.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a register nurse refers to an unspecified number of patients of unknown age and gender. Medical history and concurrent conditions were not reported. The register nurse informed that from 21-NOV-2014 through 16-JAN-2015 the patients were vaccinated with doses of PNEUMOVAX 23 0.5 ml, intramuscular, (lot # and expiration date were not reported) that were improperly stored. No adverse effects reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 48.0
Sex: F
Vaccine: MNQ
Symptoms: Arthralgia, Asthenia, Decreased appetite, Erythema, Fatigue
Clinical narrative: Reported following side effects: decreased appetite, headache, joint pain, mild fever, muscle pain, tenderness, pain, redness, swelling at injection site, tiredness, weakness, and pain in fingers.
Age: 48.0
Sex: F
Vaccine: MNQ
Symptoms: Headache, Injection site swelling, Myalgia, Pain, Pain in extremity
Clinical narrative: Reported following side effects: decreased appetite, headache, joint pain, mild fever, muscle pain, tenderness, pain, redness, swelling at injection site, tiredness, weakness, and pain in fingers.
Age: 48.0
Sex: F
Vaccine: MNQ
Symptoms: Pyrexia, Tenderness
Clinical narrative: Reported following side effects: decreased appetite, headache, joint pain, mild fever, muscle pain, tenderness, pain, redness, swelling at injection site, tiredness, weakness, and pain in fingers.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse who reported that VAQTA, (lot # not reported), was given to multiple unspecified subjects after the vaccine was exposed to temperatures outside of recommended condition. No adverse events were reported after the vaccine was administered. This is one of several reports from the same reporter source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse who reported that M-M-R II, (lot # not reported), was given to multiple unspecified subjects after the vaccine was exposed to temperatures outside of recommended condition. No adverse events were reported after the vaccine was administered. This is one of several reports from the same reporter source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to an unspecified number of patients of unknown age and gender. Medical history and concurrent conditions were not reported. The register nurse informed that from 21-NOV-2014 through 16-JAN-2015 the patients were vaccinated with doses of RECOMBIVAX HB, 0.5 nl, intramuscular, (lot # and expiration date were not reported) that were improperly stored. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse who reported that GARDASIL, was given to multiple unspecified subjects after the vaccine was exposed to temperatures outside of recommended condition. No adverse events were reported after the vaccine was administered. This is one of several reports from the same reporter 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 register nurse refers to an unspecified number of patients of unknown age and gender. Medical history and concurrent conditions were not reported. The register nurse informed that from 21-NOV-2014 through 16-JAN-2015 the patients were vaccinated with doses of GARDASIL 0.5 ml, intramuscular, (lot# and expiration date were not reported) that were improperly stored. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 1.14
Sex: F
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Pyrexia, Rash generalised
Clinical narrative: Rash all over body and fevers.
Age: 16.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Hypoaesthesia, Pain in extremity
Clinical narrative: Approximately 8pm on 1.21.15 patient began to experience pain from elbow to wrist and numbness from the shoulder to finger tips. Numbness comes and goes. Pain is constant. Seen in office 1-23-15. On 1-26-15, per mother symptoms unchanged. Coming for recheck 1-27-15
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Rash generalised, Rash macular, Rash pruritic
Clinical narrative: Pt. presented with a macular rash from head to toe x 1 day. Rash itches. Patient given cetirizine 5mg/5ml 1/2 tsp QHS.
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Dyspnoea, Hypoaesthesia oral, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness, hot, swelling around injection site 8 cm x 9 cm. Tingling and numbness of lips. Aching muscles. Shortness of breath.
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Myalgia, Paraesthesia oral
Clinical narrative: Redness, hot, swelling around injection site 8 cm x 9 cm. Tingling and numbness of lips. Aching muscles. Shortness of breath.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse who reported that PEDVAXHIB, (lot # not reported), was given to multiple unspecified subjects after the vaccine was exposed to temperatures outside of recommended condition. No adverse events were reported after the vaccine was administered. This is one of several reports from the same reporter source. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a register nurse refers to an unspecified number of patients of unknown age and gender. Medical history and concurrent conditions were not reported. The register nurse informed that from 21-NOV-2014 through 16-JAN-2015 the patients were vaccinated with doses of VAQTA 0.5 ml, intramuscular, (lot # and expiration date were not reported) that were improperly stored. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: FLU4
Symptoms: Adverse event following immunisation, Nerve injury
Clinical narrative: Initial unsolicited report received from a consumer on 19 January 2015. A female patient (age and date of birth not reported), with reported allergies to ginger, cats and dogs, had received an intramuscular dose of FLUZONE QIV (lot number and site of administration not reported) on 2013. In 2013, an unspecified time after she received FLUZONE QIV, she experienced a "terrible reaction". She developed nerve damage. The events required a doctor visit. Potential illness at time of vaccination, concomitant treatment, corrective treatment and relevant diagnostic tests were not provided. Outcome was reported as unknown. Documents held by sender: none.
Age: 55.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Cellulitis
Clinical narrative: Case number PHHY2014US171112 is an initial spontaneous report received from a healthcare professional via the Vaccine Adverse Event Reporting System (VAERS ID: 549600) website on 29 Dec 2014, with the follow-up information received from Quality Assurance Department (reference number: 345756) on 20 Jan 2015: This report refers to a 55 year old male patient. His past medical history and concomitant medications were not reported. On 07 Oct 2014, he was vaccinated with FLUVIRIN (batch number: unknown) into his left arm and with PNEUMOVAX (other manufacturer, batch number: K00905) into his left arm. On an unspecified date after vaccination, he developed cellulitis. He visited the emergency room on an unspecified date. The outcome of the event was unknown. The event was reported as non serious but the seriousness of cellulitis was upgraded based on the information available in the source documents and causality of the event was not reported. QA department stated that, as no batch number was provided, this batch review was performed based on a general review of the quality requirements for FLUVIRIN and the Annual Product Review for the FLUVIRIN 2013, it was concluded that FLUVIRIN manufacturing process was operated at a good level of overall control and the supporting systems are effective in supporting the compliant production, testing and supply processes for FLUVIRIN vaccine. From this conclusion there was no reason or explanation to account for the reported adverse event. Non-significant follow up information received from the Quality Assurance Department (reference number: 345756) on 12 Jan 2015: Updated QA reference number. Follow-up information received from the Quality Assurance Department (reference number: 345756) on 20 Jan 2015: Updated FLUVIRIN annual product review report.
Age: 65.0
Sex: U
Vaccine: FLUX
Symptoms: Mobility decreased, Neuropathy peripheral, Pain
Clinical narrative: Extreme pain when getting flu shot injection. Continued to get worse as time went by. Loss of upper arm movement. Extreme severe pain day and night. Diagnosis - right axillary neuropathy after flu shot injection. Treatment PT/OT.
Age: 3.0
Sex: M
Vaccine: FLUN4
Symptoms: Erythema, Urticaria
Clinical narrative: Generalized urticaria - Scattered raised hypopigmented patches with surrounding erythema on face, arms, chest, legs - 15 minutes after Flumist.
Age: 63.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Said injection site hurt.
Age: 56.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Skin infection
Clinical narrative: Skin infection, cellulitis left arm tx BACTRIM 800-160mg 1 tab BID x 7 days.
Age: 1.5
Sex: M
Vaccine: DTAP, HEPA, DTAP, HEPA, DTAP, HEPA
Symptoms: Asthenia, Cough, Crying, Erythema, Lip swelling
Clinical narrative: Initial information received on 20 January 2015 for this unsolicited case from a healthcare provider. An 18 month old male patient with a history of milk, peanut and egg allergy was vaccinated intramuscularly on 12 January 2015 with the fourth dose of DAPTACEL (batch number C4694AA), and Hepatitis A vaccine (manufacturer, batch, route and site of administration not reported). The patient was not ill at the time of vaccination. The patient's concomitant medications were not reported. Right after vaccination, on the way home he was choking and gagging and the mother had to call 911 and be taken to the emergency room. Treatment details were not reported. The patient recovered on an unreported date and time. Documents held by sender: None.
Age: 1.5
Sex: M
Vaccine: DTAP, HEPA, DTAP, HEPA, DTAP, HEPA
Symptoms: Urticaria, Wheezing
Clinical narrative: Initial information received on 20 January 2015 for this unsolicited case from a healthcare provider. An 18 month old male patient with a history of milk, peanut and egg allergy was vaccinated intramuscularly on 12 January 2015 with the fourth dose of DAPTACEL (batch number C4694AA), and Hepatitis A vaccine (manufacturer, batch, route and site of administration not reported). The patient was not ill at the time of vaccination. The patient's concomitant medications were not reported. Right after vaccination, on the way home he was choking and gagging and the mother had to call 911 and be taken to the emergency room. Treatment details were not reported. The patient recovered on an unreported date and time. Documents held by sender: None.
Age: 1.5
Sex: M
Vaccine: DTAP, HEPA, DTAP, HEPA, DTAP, HEPA
Symptoms: Asthenia, Cough, Lip swelling, Urticaria, Wheezing
Clinical narrative: Initial information received on 20 January 2015 for this unsolicited case from a healthcare provider. An 18 month old male patient with a history of milk, peanut and egg allergy was vaccinated intramuscularly on 12 January 2015 with the fourth dose of DAPTACEL (batch number C4694AA), and Hepatitis A vaccine (manufacturer, batch, route and site of administration not reported). The patient was not ill at the time of vaccination. The patient's concomitant medications were not reported. Right after vaccination, on the way home he was choking and gagging and the mother had to call 911 and be taken to the emergency room. Treatment details were not reported. The patient recovered on an unreported date and time. Documents held by sender: None.
Age: 1.5
Sex: M
Vaccine: DTAP, HEPA, DTAP, HEPA, DTAP, HEPA
Symptoms: Choking, Retching
Clinical narrative: Initial information received on 20 January 2015 for this unsolicited case from a healthcare provider. An 18 month old male patient with a history of milk, peanut and egg allergy was vaccinated intramuscularly on 12 January 2015 with the fourth dose of DAPTACEL (batch number C4694AA), and Hepatitis A vaccine (manufacturer, batch, route and site of administration not reported). The patient was not ill at the time of vaccination. The patient's concomitant medications were not reported. Right after vaccination, on the way home he was choking and gagging and the mother had to call 911 and be taken to the emergency room. Treatment details were not reported. The patient recovered on an unreported date and time. Documents held by sender: None.
Age: 2.0
Sex: M
Vaccine: FLU4, HEP, HEPA
Symptoms: Rash, Urticaria
Clinical narrative: Rash, hives, possible fever.  Pt was given Benadryl.
Age: 58.0
Sex: F
Vaccine: PPV
Symptoms: Axillary pain, Body temperature increased, Cough, Feeling cold, Injection site erythema
Clinical narrative: ENTIRE UPPER LEFT DELTOID SO SORE, COULDNT OT LIE ON DURING SLEEP THAT NIGHT. SHOWERING NOTICED ENTIRE UPPER ARM EDEMATOUS & 2 AREAS OF ERYTHEMA HORIZONTAL SEVERAL CM X CM GOING DOWN TO MY LEFT AXILLARY, ENTIRE LEFT UPPER ARM TENDER TO TOUCH & WARM. I HAVE HAD THIS IN 1994-95 & REMEMBER MY ENTIRE AXILLARY WAS SO SORE, I COULDN'T HOLD MY PURSE, BUT NOT THIS MUCH EDEMA/ERYTHEMA. I AM A FAMILY NURSE PRACTITIONER & HAVE GIVEN THOUSANDS OF ALL VACCINES, HAVE NEVER SEEN THIS. ALSO, THE NIGHT OF THE VACCINE, I GOT A SORE THROAT, WHICH I STILL HAVE, STARTED COUGHING YESTERDAY, 1/26, STILL COUGHING, & NOW FEEL COLD & HAVE A TEMPERATURE OF 100.4. I HAD ANOTHER ICU RN LOOK @ MY ARM & SHE CONCURRED TO REPORT. WE HAVE HAD 7 PEOPLE INCLUDING CHILDREN DIE DUE TO INFLUENZA A DESPITE BEING IMMUNIZED. I GOT MY FLU SHOT IN AUGUST 2014 & MY HUSBAND THE SAME DAY & HE ALSO GOT THE SAME Pneumovax 23 vaccine the same day/time & he is fine & he is severly allergic to the Td & has asthma, eczema, etc., triad.
Age: 58.0
Sex: F
Vaccine: PPV
Symptoms: Injection site oedema, Injection site pain, Injection site warmth, Insomnia, Oropharyngeal pain
Clinical narrative: ENTIRE UPPER LEFT DELTOID SO SORE, COULDNT OT LIE ON DURING SLEEP THAT NIGHT. SHOWERING NOTICED ENTIRE UPPER ARM EDEMATOUS & 2 AREAS OF ERYTHEMA HORIZONTAL SEVERAL CM X CM GOING DOWN TO MY LEFT AXILLARY, ENTIRE LEFT UPPER ARM TENDER TO TOUCH & WARM. I HAVE HAD THIS IN 1994-95 & REMEMBER MY ENTIRE AXILLARY WAS SO SORE, I COULDN'T HOLD MY PURSE, BUT NOT THIS MUCH EDEMA/ERYTHEMA. I AM A FAMILY NURSE PRACTITIONER & HAVE GIVEN THOUSANDS OF ALL VACCINES, HAVE NEVER SEEN THIS. ALSO, THE NIGHT OF THE VACCINE, I GOT A SORE THROAT, WHICH I STILL HAVE, STARTED COUGHING YESTERDAY, 1/26, STILL COUGHING, & NOW FEEL COLD & HAVE A TEMPERATURE OF 100.4. I HAD ANOTHER ICU RN LOOK @ MY ARM & SHE CONCURRED TO REPORT. WE HAVE HAD 7 PEOPLE INCLUDING CHILDREN DIE DUE TO INFLUENZA A DESPITE BEING IMMUNIZED. I GOT MY FLU SHOT IN AUGUST 2014 & MY HUSBAND THE SAME DAY & HE ALSO GOT THE SAME Pneumovax 23 vaccine the same day/time & he is fine & he is severly allergic to the Td & has asthma, eczema, etc., triad.
Age: 27.0
Sex: F
Vaccine: DTAP
Symptoms: Fatigue, Head discomfort, Oropharyngeal pain, Pain in extremity
Clinical narrative: On top of my arm feeling extremely sore I became tired and have developed a sore throat throughout the night. I feel heavy-headed also with no symptoms of sickness before the shot.
Age: 67.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Dizziness, Hypoaesthesia, Paraesthesia
Clinical narrative: Left hand and fingers became tingly and numb dizzy and light headed called pharmacy was told if I didn't get better to go to doctor.
Age: 17.0
Sex: F
Vaccine: FLU4, HPV4, MNQ, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Pt reported swelling, warmth, redness and hardness at injection site @ L upper arm.  Patient states she treated self with Benadryl.
Age: 45.0
Sex: F
Vaccine: FLUR3
Symptoms: Rash
Clinical narrative: Rash on back.
Age: 34.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Lymphadenopathy, Mass, Myalgia, Pain
Clinical narrative: Pt reports "deltoid full of fever"; reported to nurse swelling with home health nurse palpating 5 cm lump with pt reporting continuing to swell "size of silver dollar", arm painful to touch and raise for range of motion.  Pt reports "lump is red, my clavical lymph nodes are swollen and the muscles going up into my neck hurt." Pt advised to continue Tylenol as directed, alternate ice and heat and call back with fever, increase in swellling, pain or redness, body aches and/or chills.
Age: 34.0
Sex: F
Vaccine: TDAP
Symptoms: Skin warm, Swelling, Tenderness
Clinical narrative: Pt reports "deltoid full of fever"; reported to nurse swelling with home health nurse palpating 5 cm lump with pt reporting continuing to swell "size of silver dollar", arm painful to touch and raise for range of motion.  Pt reports "lump is red, my clavical lymph nodes are swollen and the muscles going up into my neck hurt." Pt advised to continue Tylenol as directed, alternate ice and heat and call back with fever, increase in swellling, pain or redness, body aches and/or chills.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Aphagia, Calculus urinary, Dehydration, Discomfort
Clinical narrative: This spontaneous consumer report (initial receipt 15-Jan-2015) concerns a 63 year old female patient. The patient had medical history of an allergy to mercury. On 02-Jan-2015, the patient received intramuscular AFLURIA (batch number 'T511708') at 0.5 ml annually. This was the first time the patient received the flu shot. The patient did not receive seasonal influenza vaccine or monovalent 2009 H1N1 vaccine in the past. On 02-Jan-2015, after the injection, the patient experienced redness, swelling, bruising and a hot to touch bump, where the shot was administered. The patient described the bruise as 4 inches in length and 2 inches wide. Later, her arm could not move or rotate and she felt tingling in her hands - both of which caused her difficulties in getting dressed. Two days later, she felt pressure and burning when trying to urinate. Approximately three days later, she had a temperature of 103 degrees Fahrenheit fever. She also experienced a severe headache and nausea and could not eat or drink. This caused her to be dehydrated and she also passed a kidney stone recently. She saw the physician for kidney stone. The patient received treatment with acetaminophen for fever and headaches from the 02-Jan-2015 until 07-Jan-2015 which did not alleviate her symptoms. The patient also received treatment for kidney stones. The outcome was reported as not yet recovered (recovering but not fully recovered), except for the event of arm could not move or rotate and hand tingling which resolved on 07-Jan-2015. Reporter comments: The reporter causality/relatedness was assessed as related. The patient required consultation with a doctor but no admission to hospital to hospital emergency department.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Dysuria, Headache, Injection site bruising, Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous consumer report (initial receipt 15-Jan-2015) concerns a 63 year old female patient. The patient had medical history of an allergy to mercury. On 02-Jan-2015, the patient received intramuscular AFLURIA (batch number 'T511708') at 0.5 ml annually. This was the first time the patient received the flu shot. The patient did not receive seasonal influenza vaccine or monovalent 2009 H1N1 vaccine in the past. On 02-Jan-2015, after the injection, the patient experienced redness, swelling, bruising and a hot to touch bump, where the shot was administered. The patient described the bruise as 4 inches in length and 2 inches wide. Later, her arm could not move or rotate and she felt tingling in her hands - both of which caused her difficulties in getting dressed. Two days later, she felt pressure and burning when trying to urinate. Approximately three days later, she had a temperature of 103 degrees Fahrenheit fever. She also experienced a severe headache and nausea and could not eat or drink. This caused her to be dehydrated and she also passed a kidney stone recently. She saw the physician for kidney stone. The patient received treatment with acetaminophen for fever and headaches from the 02-Jan-2015 until 07-Jan-2015 which did not alleviate her symptoms. The patient also received treatment for kidney stones. The outcome was reported as not yet recovered (recovering but not fully recovered), except for the event of arm could not move or rotate and hand tingling which resolved on 07-Jan-2015. Reporter comments: The reporter causality/relatedness was assessed as related. The patient required consultation with a doctor but no admission to hospital to hospital emergency department.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site warmth, Mobility decreased, Nausea, Paraesthesia, Pyrexia
Clinical narrative: This spontaneous consumer report (initial receipt 15-Jan-2015) concerns a 63 year old female patient. The patient had medical history of an allergy to mercury. On 02-Jan-2015, the patient received intramuscular AFLURIA (batch number 'T511708') at 0.5 ml annually. This was the first time the patient received the flu shot. The patient did not receive seasonal influenza vaccine or monovalent 2009 H1N1 vaccine in the past. On 02-Jan-2015, after the injection, the patient experienced redness, swelling, bruising and a hot to touch bump, where the shot was administered. The patient described the bruise as 4 inches in length and 2 inches wide. Later, her arm could not move or rotate and she felt tingling in her hands - both of which caused her difficulties in getting dressed. Two days later, she felt pressure and burning when trying to urinate. Approximately three days later, she had a temperature of 103 degrees Fahrenheit fever. She also experienced a severe headache and nausea and could not eat or drink. This caused her to be dehydrated and she also passed a kidney stone recently. She saw the physician for kidney stone. The patient received treatment with acetaminophen for fever and headaches from the 02-Jan-2015 until 07-Jan-2015 which did not alleviate her symptoms. The patient also received treatment for kidney stones. The outcome was reported as not yet recovered (recovering but not fully recovered), except for the event of arm could not move or rotate and hand tingling which resolved on 07-Jan-2015. Reporter comments: The reporter causality/relatedness was assessed as related. The patient required consultation with a doctor but no admission to hospital to hospital emergency department.
Age: 72.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Nodule, Pain, Pruritus, Skin warm
Clinical narrative: Red, sore, knot, warm to touch, pain with pressure, itchy, some pain with elevation of arm; treated with heating pad x30 min 3x/day and Aleve OTC & red spot on chest near armpit that lasted 4 days. Currently still recovering multiple knotty areas still present.
Age: 72.0
Sex: M
Vaccine: PPV
Symptoms: Tenderness
Clinical narrative: Red, sore, knot, warm to touch, pain with pressure, itchy, some pain with elevation of arm; treated with heating pad x30 min 3x/day and Aleve OTC & red spot on chest near armpit that lasted 4 days. Currently still recovering multiple knotty areas still present.
Age: 0.74
Sex: F
Vaccine: DTAPIPV, HIBV, PNC13
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Kinrix given to 9mo old child. No adverse events reported.