chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: F
Vaccine: HEPA, VARZOS
Symptoms: Erythema, Pruritus
Clinical narrative: BRIGHT RED AREA MEASURES 5.5CM X 2CM; PINK AREA MEASURES 14CM X 7.5CM; VERY ITCHY. TX: CLARITIN; WILL START THIS EVENING (5/22): ZYRTEC; TRIAMCINOLONE CREAM 0.1% TWICE DAILY; ZANTAC 150MG.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Aphasia, Aphonia, Cough, Injection site reaction, Lymph node pain
Clinical narrative: This spontaneous report as received from a 69 year old female patient with no pertinent medical history refers to herself with drug allergy to aspirin and iodine. On 13-MAR-2014 the patient was vaccinated with one single injection of ZOSTAVAX. The patient reported on 14-MAR-2014, she developed loss of voice, cough, low grade fever, injection site reaction and rash after receiving the ZOSTAVAX vaccine. She was now left with a swollen gland and it was sore. She went to Urgent Care (demographics unknown) and the doctors didn't know what's wrong with her. She also had a tube down her throat and nose and nothing was wrong. The ear-nose-throat (ENT) doctor did all the throat and nose testing. The ENT doctor put her on prednisone 10 MG/3 pills daily for three days and as the days went on the dose lowered and nothing worked and she really could no talk a lot now and this had been going on for almost 10 weeks now. She was also using many other unspecified medications (names/dosages/frequencies/manufacturers unknown) but she could even talk to be able to tell what they were. The outcome of the events was reported as not recovered. Upon internal review, loss of voice was determined to be medically significant. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Lymphadenopathy, Pyrexia, Rash
Clinical narrative: This spontaneous report as received from a 69 year old female patient with no pertinent medical history refers to herself with drug allergy to aspirin and iodine. On 13-MAR-2014 the patient was vaccinated with one single injection of ZOSTAVAX. The patient reported on 14-MAR-2014, she developed loss of voice, cough, low grade fever, injection site reaction and rash after receiving the ZOSTAVAX vaccine. She was now left with a swollen gland and it was sore. She went to Urgent Care (demographics unknown) and the doctors didn't know what's wrong with her. She also had a tube down her throat and nose and nothing was wrong. The ear-nose-throat (ENT) doctor did all the throat and nose testing. The ENT doctor put her on prednisone 10 MG/3 pills daily for three days and as the days went on the dose lowered and nothing worked and she really could no talk a lot now and this had been going on for almost 10 weeks now. She was also using many other unspecified medications (names/dosages/frequencies/manufacturers unknown) but she could even talk to be able to tell what they were. The outcome of the events was reported as not recovered. Upon internal review, loss of voice was determined to be medically significant. Additional information has been requested.
Age: 18.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Hypoaesthesia, Muscular weakness, Myelitis transverse, Neck pain, Nuclear magnetic resonance imaging
Clinical narrative: Maybe 2 wks after #2 HPV, developed neck pain that progressed to right then bil. arm and leg numbness and weakness. Hospitalized and dx with transverse myelitis. Being followed by neurologist.
Age: 18.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Pain in extremity
Clinical narrative: Maybe 2 wks after #2 HPV, developed neck pain that progressed to right then bil. arm and leg numbness and weakness. Hospitalized and dx with transverse myelitis. Being followed by neurologist.
Age: 18.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Myelitis transverse
Clinical narrative: Maybe 2 wks after #2 HPV, developed neck pain that progressed to right then bil. arm and leg numbness and weakness. Hospitalized and dx with transverse myelitis. Being followed by neurologist.
Age: 14.0
Sex: F
Vaccine: IPV, MNQ
Symptoms: Incorrect storage of drug
Clinical narrative: Temperature excursions of vaccine(s) listed in item 13.
Age: 3.0
Sex: F
Vaccine: PNC13
Symptoms: Incorrect storage of drug
Clinical narrative: Temperature excursions of vaccine(s) listed in item 13.
Age: 5.0
Sex: M
Vaccine: MMR
Symptoms: Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Swelling of right arm, indurated, no erythema, mildly tender to palpation.
Age: 0.2
Sex: U
Vaccine: RV5
Symptoms: Haematochezia
Clinical narrative: This spontaneous report was received from a physician concerning a 2 month old patient of unknown age. Medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with ROTATEQ (dose, strength, lot number, expiration date and route were not reported). Co-suspect and concomitant therapies were not reported. The physician reported that on an unknown date, the 2 month old child had bloody stools for 9 days. At the time of the report the outcome was unknown. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Drug administered at inappropriate site, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown gender and age. On an unknown date, the patients were vaccinated with a dose of ZOSTAVAX (dose and lot # not reported) SQ in the abdominal region as a result of the unspecified patients being amputees. No adverse effect was reported. Additional information is not expected.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. No information on medical history, concurrent conditions or concomitant drugs was provided. The patient was vaccinated with PNEUMOVAX 23, (dose, route and site of administration not reported) lot # H014283 and expiration date 17-APR-2014 on 02-MAY-2014. There was no adverse reaction reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacists refers to a patient of unknown age and unknown gender. Medical history and current conditions not reported. On 12-MAY-2014 the patient was inadvertently vaccinated with PNEUMOVAX 23 (strength, lot number and dose number were unspecified) which expired on 09-Mar-2014. No concomitant therapies were reported. No adverse effects reported. The outcome of the event was unknown. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker concerning an adult patient of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date the patient was vaccinated a dose of MMR II (dose, strength, lot number, expiration date and route were not reported). Co-suspect and concomitant therapies were not reported. On 14-MAY-2014, an adult patient was administered MMR II for the first time. No adverse effects reported. Additional information is not expected.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Skin discolouration, Skin swelling, Skin tightness, Tenderness
Clinical narrative: This spontaneous report as received from a physician, reporting on himself, a 58 year old male patient with hypothyroid and no drug reaction/allergies. On 08-MAY-2014, the patient was vaccinated with a dose of ZOSTAVAX (strength was no reported) lot # J014851, expiration date 24-OCT-2014, 0.65 ml, subcutaneous injection. Concomitant therapies included SYNTHROID. The physician experienced a 4 cm, circular, red, swollen skin reaction on 09-MAY-2014, after receiving ZOSTAVAX. Physician reported on 10-MAY-2014, there was deep purple tracking down to left elbow; skin around injection site was tense. Physician became concerned and contacted unspecified infectious disease physician and was advised to start KEFLEX. Physician reported that there has been improvement with color, erythema, tracking was gone and area was less tender following the KEFLEX, cold compresses and heat. At the time of the report the outcome was recovering. Patient received as treatment heat, cold compresses and KEFLEX. No lab diagnostics studies were performed. Additional information has been requested.
Sex: F
Vaccine: RV5
Symptoms: Diarrhoea, Dyspnoea, Hypersensitivity
Clinical narrative: This spontaneous report as received from a consumer refers to her daughter who was a female patient between 9 months to 1 year old (currently 7 year old). The reporter said that her daughter had an allergic reaction that included a rash, trouble breathing, and diarrhea to ROTATEQ when she was between the ages of 9-months and 1-year. On an unknown date the patient was vaccinated with the first dose of ROTATEQ (lot # not reported) (strength, dose, route unknown). On an unknown date (reported as between the ages of 9-months and 1-year) the patient experienced a mild allergic reaction after the first dose of ROTATEQ. On an unknown date (reported as between the ages of 9-months and 1-year) the patient experienced a more intense reaction to the second dose of ROTATEQ resulting in the child being rushed to Urgent Care. The outcome of the mild allergic reaction and a more intense allergic reaction was unknown. The causality of the events and ROTATEQ was unknown. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of unknown demographics. On 20-NOV-2013, the patient was vaccinated with PNEUMOVAX23 injection 25/0.5 Y, dose 1, intramuscular. On an unknown date in January 2014 (also reported as February 2014) the patient was vaccinated with PNEUMOVAX23 injection 25/0.5 Y, dose 2, intramuscular. Approximately on an unknown date in January 2014 (also reported as February 2014) the patient received two doses of PNEUMOVAX23 within 2-3 months inadvertently. First dose was administered on 20-NOV-2013 at pharmacy and second dose was given at unspecified physician office on an unknown date in January or February 2014. No adverse effects to report. There was no product quality compliant (PQC) involved. The outcome of patient received two doses of PNEUMOVAX within 2-3 months inadvertently is unknown. Additional information has been requested.
Age: 0.6
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a 6 month old patient of unknown gender. There was no information about medical history/concurrent conditions and concomitant medication. On an unspecified date the patient was vaccinated with the first dose of ROTATEQ (lot# and dose unspecified) and no adverse events reported. The outcome of the event was unknown. Additional information has been requested.
Age: 19.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Antibody test negative
Clinical narrative: This spontaneous report as received from a physician refers to a currently 19 year old male patient. "15 years ago", in approximately May 1999 the patient was vaccinated with M-M-R II (strength, dose and lot# not reported) and VARIVAX (Merck) (strength, dose and lot# not reported). On an unknown date the patient's titers were low. The outcome of patient's titers were low was unknown. It was unspecified if the patient sought medical attention. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Maternal exposure before pregnancy, No adverse event, Pregnancy test urine positive
Clinical narrative: This spontaneous prospective pregnancy report as received from a other health professional refers to a 17 years old female patient of unknown age. On 12-MAR-2014 the patient was vaccinated with VARIVAX (Merck) (lot # was not reported) and M-M-R II (lot # was not reported). The patient became pregnant with LMP of 24-MAR-2014 and EDD of 29-DEC-2014 (also reported estimated date of confinement was 31-DEC-2014). It was 5 weeks Gestation when reported. The patient took a urine home pregnancy test and it was positive. Another urine pregnancy test was performed at the student wellness center and was indeed positive. The patient did not experienced any adverse events. No treatment was given. The pregnancy outcome was pending. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report as received from an office manager refers to a 65 year old male patient with hypertension. On 13-MAY-2014 the patient was vaccinated with a dose of PNEUMOVAX 23 (dose not specified, intramsucularly, Lot# reported as K004207, expiration date: 13-MAR-2015). Concomitant therapies included lisinopril (manufacturer unknown). On an unspecified date in May 2014 patient experienced swelling at injection site, pain at the injection site and redness at injection site. The patient was instructed by physician to treat the site with ice. No laboratory diagnostics were performed. No hospitalization was involved. The outcome of swelling at injection site, redness at injection site and pain at the injection site was reported as not recovered/not resolved. Causality was not provided. Additional information has been requested.
Age: 0.51
Sex: M
Vaccine: DTAPIPV, HEP, HIBV, PNC13
Symptoms: Unevaluable event
Clinical narrative: None at this time
Age: 22.0
Sex: M
Vaccine: TYP
Symptoms: Nausea, Pyrexia
Clinical narrative: Nausea, slight fever.
Age: 0.34
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Injection site erythema, Irritability
Clinical narrative: Returned to office 6 hours after immunization with redness at site of PENTACEL and fussiness. Exam significant for 16 cm x 10 cm of erythema centered at anterior medial right thigh, no induration palpated. Rest of exam normal. Redness resolved in a couple hours - slight fussiness the rest of the evening.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site rash, Pruritus, Rash
Clinical narrative: Rash around injection site and then went across the top part of back on to her other arm and itchy.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Fall, Vomiting
Clinical narrative: A few minutes after receiving immunizations child began to fall. Mother and RN caught child and assisted her to sit down. After a few minutes we assisted to walk her to a place to lie down. While getting onto cot, child vomited. VS taken -> all normal. After about 20 min, child and mom left clinic.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Pain
Clinical narrative: Arm still sore since flu shot.
Age: 16.0
Sex: F
Vaccine: IPV, MNQ
Symptoms: Incorrect storage of drug
Clinical narrative: Temperature excursions of vaccine(s) listed in item 13.
Age: 1.57
Sex: F
Vaccine: PNC13
Symptoms: Incorrect storage of drug
Clinical narrative: Temperature excursions of vaccine(s) listed in item 13.
Age: 0.29
Sex: F
Vaccine: PNC13
Symptoms: Incorrect storage of drug
Clinical narrative: Temperature excursions of vaccine (s) listed in item 13.
Age: 1.07
Sex: F
Vaccine: PNC13
Symptoms: Incorrect storage of drug
Clinical narrative: Temperature excursions of vaccine(s) listed in item 13.
Age: 38.0
Sex: M
Vaccine: HEP
Symptoms: Unevaluable event
Clinical narrative: None.
Age: 82.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blood blister, Haemorrhage, Immediate post-injection reaction
Clinical narrative: After removing needle, the patient's arm (right) began to bleed. A bubble developed under the skin, as if filled with blood about the size of a quarter. (Applied light pressure and band aid.)
Age: 82.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site haematoma, Injection site pain
Clinical narrative: After removing needle, the patient's arm (right) began to bleed. A bubble developed under the skin, as if filled with blood about the size of a quarter. (Applied light pressure and band aid.)
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, RV5
Symptoms: Crying, Irritability
Clinical narrative: Fussiness: unexplained crying for 45 minutes, 5 hours after receiving vaccines.
Age: 65.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Erythema, Oedema, Pain, Skin warm
Clinical narrative: Hot to the touch, edema, redness and pain.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site cellulitis, Injection site erythema
Clinical narrative: 12 x 8 cm erythematous area (+) color without tenderness (R) deltoid area.
Age: 0.99
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Pyrexia, Rash, Viral rash
Clinical narrative: Rash and fever. Symptomatic care.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Dyskinesia, Fall, Hyperhidrosis, Loss of consciousness, Pallor
Clinical narrative: 15 min after admin. of HPV vaccine, mom reported client had jerking motions of arms as if having "seizure", then slumped over onto mom while in sitting position. Nurse found pt. awake, pale, diaphoretic in sitting position. Pt states "I blacked out". Placed pt's head down between knees. Within 2-3 min color pinked up. Client moved to supine position on floor. Ambulance called. Assessed and counseled by paramedics. Mom declined ambulance ride to ER. Client walked out of clinic w/mom in satisfactory condition. Per follow up call on 5/22 mom states doing well and has consulted w/MD.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Seizure like phenomena
Clinical narrative: 15 min after admin. of HPV vaccine, mom reported client had jerking motions of arms as if having "seizure", then slumped over onto mom while in sitting position. Nurse found pt. awake, pale, diaphoretic in sitting position. Pt states "I blacked out". Placed pt's head down between knees. Within 2-3 min color pinked up. Client moved to supine position on floor. Ambulance called. Assessed and counseled by paramedics. Mom declined ambulance ride to ER. Client walked out of clinic w/mom in satisfactory condition. Per follow up call on 5/22 mom states doing well and has consulted w/MD.
Age: 19.0
Sex: F
Vaccine: VARCEL
Symptoms: Discomfort, Erythema, Induration, Pruritus
Clinical narrative: Patient states she noticed a little discomfort and itching on 5/21/14 around 5 p.m. On 5/22/14 patient came in for a Mantoux reading and asked about the reaction. The redness was 6cm by 5cm with induration. No other symptoms.
Age: 4.0
Sex: F
Vaccine: FLU3, MMRV
Symptoms: Injection site bruising, Pyrexia, Skin warm
Clinical narrative: Mom noticed bruising on left arm at about 7 pm yesterday. As per child warm to touch. Had fever of 101.3 on Wednesday 2-3 pm at school throughout the night.
Age: 40.0
Sex: M
Vaccine: HEPAB, MMR, TDAP
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Myalgia, Ocular icterus, Pyrexia
Clinical narrative: Per MD note: Pt presented to ER with C/O N/V, myalgias, fever and yellow eyes. MD attributes these symptoms to recent hepatitis vaccinations. This is known but not very common reaction. See attached notes.
Age: 0.99
Sex: F
Vaccine: PNC13
Symptoms: Incorrect storage of drug
Clinical narrative: Temperature excursions of vaccine(s) listed in item 13.
Age: 14.0
Sex: M
Vaccine: IPV
Symptoms: Incorrect storage of drug
Clinical narrative: Temperature excursions of vaccine(s) listed in item 13.
Age: 1.11
Sex: M
Vaccine: PNC13
Symptoms: Incorrect storage of drug
Clinical narrative: Temperature excursions of vaccine (s) listed in item 13.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect storage of drug
Clinical narrative: Temperature excursions of vaccine(s) listed in item 13.
Age: 2.0
Sex: F
Vaccine: PNC13
Symptoms: Incorrect storage of drug
Clinical narrative: Temperature excursions of vaccine (s) listed in item 13.
Age: 0.85
Sex: F
Vaccine: IPV, PNC13
Symptoms: Incorrect storage of drug
Clinical narrative: Temperature excursions of vaccine(s) listed in item 13.
Age: 0.75
Sex: F
Vaccine: PNC13
Symptoms: Incorrect storage of drug
Clinical narrative: Temperature excursions of vaccine(s) listed in item 13.
Age: 3.0
Sex: M
Vaccine: PNC13
Symptoms: Incorrect storage of drug
Clinical narrative: Temperature excursions of vaccine(s) listed in item 13.
Age: 1.0
Sex: F
Vaccine: PNC13
Symptoms: Incorrect storage of drug
Clinical narrative: Temperature excursions of vacine(s) listed in item 13.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect storage of drug
Clinical narrative: Temperature excursions of vaccine (s) listed in item 13.
Age: 0.17
Sex: F
Vaccine: PNC13
Symptoms: Incorrect storage of drug
Clinical narrative: Temperature excursions of vaccine(s) listed in item 13.
Age: 0.64
Sex: M
Vaccine: PNC13
Symptoms: Incorrect storage of drug
Clinical narrative: Temperature excursions of vaccine(s) listed in item 13.
Age: 1.01
Sex: M
Vaccine: PNC13
Symptoms: Incorrect storage of drug
Clinical narrative: Temperature excursions of vaccine (s) listed in item 13.
Age: 1.16
Sex: F
Vaccine: PNC13
Symptoms: Incorrect storage of drug
Clinical narrative: Temperature excursions of vaccine(s) listed in item 13.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect storage of drug
Clinical narrative: Temperature excursions of vaccine (s) listed in item 13.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect storage of drug
Clinical narrative: Temperature excursions of vaccine (s) listed in item 13.
Age: 18.0
Sex: M
Vaccine: IPV
Symptoms: Incorrect storage of drug
Clinical narrative: Temperature excursions of vaccine(s) listed in item 13.
Age: 8.0
Sex: F
Vaccine: IPV
Symptoms: Incorrect storage of drug
Clinical narrative: Temperature excursions of vaccine(s) listed in item 13.
Age: 14.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect storage of drug
Clinical narrative: Temperature excursions of vaccine(s) listed in item 13.
Age: 1.0
Sex: F
Vaccine: PNC13
Symptoms: Incorrect storage of drug
Clinical narrative: Temperature excursions of vaccine(s) listed in item 13.
Age: 0.56
Sex: M
Vaccine: IPV, PNC13
Symptoms: Incorrect storage of drug
Clinical narrative: Temperature excursions of vaccine(s) listed in item 13.
Age: 1.03
Sex: M
Vaccine: PNC13
Symptoms: Incorrect storage of drug
Clinical narrative: Temperature excursions of vaccine(s) listed in item 13.
Age: 4.0
Sex: F
Vaccine: PNC13
Symptoms: Incorrect storage of drug
Clinical narrative: Temperature excursions of vaccine(s) listed in item 13.
Age: 0.3
Sex: F
Vaccine: PNC13
Symptoms: Incorrect storage of drug
Clinical narrative: Temperature excursions of vaccine(s) listed in item 13.
Age: 2.0
Sex: F
Vaccine: PNC13
Symptoms: Incorrect storage of drug
Clinical narrative: Temperature excursions of vaccine(s) listed in item 13.
Age: 15.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect storage of drug
Clinical narrative: Temperature excursions of vaccine (s) listed in item 13.
Age: 0.32
Sex: F
Vaccine: PNC13
Symptoms: Incorrect storage of drug
Clinical narrative: Temperature excursions of vaccine (s) listed in item 13.
Age: 12.0
Sex: M
Vaccine: IPV
Symptoms: Incorrect storage of drug
Clinical narrative: Temperature excursions of vaccine(s) listed in item 13.
Age: 0.53
Sex: M
Vaccine: PNC13
Symptoms: Incorrect storage of drug
Clinical narrative: Temperature excursions of vaccine (s) listed in item 13.
Age: 11.0
Sex: M
Vaccine: IPV, MNQ
Symptoms: Incorrect storage of drug
Clinical narrative: Temperature excursions of vaccine(s) listed in item 13.
Age: 0.26
Sex: F
Vaccine: PNC13
Symptoms: Incorrect storage of drug
Clinical narrative: Temperature excursions of vaccine(s) listed in item 13.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect storage of drug
Clinical narrative: Temperature excursions of vaccine(s) listed in item 13.
Age: 0.51
Sex: M
Vaccine: PNC13
Symptoms: Incorrect storage of drug
Clinical narrative: Temperature excursions of vaccine (s) listed in item 13.
Age: 16.0
Sex: F
Vaccine: IPV
Symptoms: Incorrect storage of drug
Clinical narrative: Temperature excursions of vaccine(s) listed in item 13.
Age: 0.79
Sex: M
Vaccine: PNC13
Symptoms: Incorrect storage of drug
Clinical narrative: Temperature excursions of vaccine(s) listed in item 13.
Age: 11.0
Sex: F
Vaccine: IPV
Symptoms: Incorrect storage of drug
Clinical narrative: Temperature excursions of vaccine(s) listed in item 13.
Age: 0.79
Sex: F
Vaccine: PNC13
Symptoms: Incorrect storage of drug
Clinical narrative: Temperature excursions of vaccine (s) listed in item 13.
Age: 1.19
Sex: M
Vaccine: PNC13
Symptoms: Incorrect storage of drug
Clinical narrative: Temperature excursions of vaccine (s) listed in item 13.
Age: 0.36
Sex: F
Vaccine: IPV, PNC13
Symptoms: Incorrect storage of drug
Clinical narrative: Temperature excursions of vaccine(s) listed in item 13.
Age: 1.43
Sex: F
Vaccine: PNC13
Symptoms: Incorrect storage of drug
Clinical narrative: Temperature excursions of vaccine(s) listed in item 13.
Age: 0.19
Sex: F
Vaccine: PNC13
Symptoms: Incorrect storage of drug
Clinical narrative: Temperature excursions of vaccine(s) listed in item 13.
Age: 0.18
Sex: F
Vaccine: PNC13
Symptoms: Incorrect storage of drug
Clinical narrative: Temperature excursions of vaccine(s) listed in item 13.
Age: 3.0
Sex: F
Vaccine: IPV
Symptoms: Incorrect storage of drug
Clinical narrative: Temperature excursions of vaccine(s) listed in item 13.
Age: 0.45
Sex: F
Vaccine: PNC13
Symptoms: Incorrect storage of drug
Clinical narrative: Temperature excursions of vaccine(s) listed in item 13
Age: 13.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect storage of drug
Clinical narrative: Temperature excursions of vaccine (s) listed in item 13.
Age: 0.18
Sex: F
Vaccine: PNC13
Symptoms: Incorrect storage of drug
Clinical narrative: Temperature excursions of vaccine (s) listed in item 13.
Age: 0.74
Sex: F
Vaccine: IPV, PNC13
Symptoms: Incorrect storage of drug
Clinical narrative: Temperature excursions of vaccine(s) listed in item 13.
Age: 0.52
Sex: M
Vaccine: PNC13
Symptoms: Incorrect storage of drug
Clinical narrative: Temperature excursions of vaccine(s) listed in item 13.
Age: 2.0
Sex: M
Vaccine: PNC13
Symptoms: Incorrect storage of drug
Clinical narrative: Temperature excursions of vaccine(s) listed in item 13.
Age: 0.26
Sex: M
Vaccine: PNC13
Symptoms: Incorrect storage of drug
Clinical narrative: Temperature excursions of vaccine(s) listed in item 13.
Age: 1.5
Sex: M
Vaccine: IPV
Symptoms: Incorrect storage of drug
Clinical narrative: Temperature excursions of vaccine(s) llisted in item 13.
Age: 2.0
Sex: F
Vaccine: IPV, PNC13
Symptoms: Incorrect storage of drug
Clinical narrative: Temperature excursions of vaccine(s) listed in item 13.
Age: 2.0
Sex: M
Vaccine: IPV, PNC13
Symptoms: Incorrect storage of drug
Clinical narrative: Temperature excursions of vaccine(s) listed in item 13.
Age: 0.34
Sex: M
Vaccine: IPV, PNC13
Symptoms: Incorrect storage of drug
Clinical narrative: Temperature excursions of vaccine(s) listed in item 13.
Age: 2.0
Sex: F
Vaccine: IPV
Symptoms: Incorrect storage of drug
Clinical narrative: Temperature excursions of vaccine(s) listed in item 13.
Age: 0.2
Sex: M
Vaccine: PNC13
Symptoms: Incorrect storage of drug
Clinical narrative: Temperature excursions of vaccine(s) listed in item 13.
Age: 11.0
Sex: M
Vaccine: IPV
Symptoms: Incorrect storage of drug
Clinical narrative: Temperature excursions of vaccine(s) listed in item 13.
Age: 0.33
Sex: F
Vaccine: IPV, PNC13
Symptoms: Incorrect storage of drug
Clinical narrative: Temperature excursions of vaccine(s) listed in item 13.
Age: 0.56
Sex: F
Vaccine: PNC13
Symptoms: Incorrect storage of drug
Clinical narrative: Temperature excursions of vaccine(s) listed in item 13.
Age: 0.59
Sex: M
Vaccine: PNC13
Symptoms: Incorrect storage of drug
Clinical narrative: Temperature excursions of vaccine(s) listed in item 13.
Age: 18.0
Sex: F
Vaccine: FLU(H1N1), FLU3
Symptoms: Electroencephalogram, Narcolepsy, Sleep study, Somnolence
Clinical narrative: Case number PHHY2012US108468 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 457761) on 05 Sep 2012, with the follow-up received from Quality Assurance Department (reference number: 209251) on 18 May 2014: This report refers to an 18-year-old female patient. Her medical history included Epilepsy diagnosed in 2005 (petite mal variant) and penicillin and ceclor allergy. She was vaccinated with FLUVIRIN (batch number unknown) along with S-OIV FLUVIRIN (batch number: 101716P1A) in to the right arm on 28 Oct 2009. On 05 Jan 2010 she presented with excessive sleepiness and was diagnosed with narcolepsy by a neurologist. A sleep study and an electroencephalogram were performed in Jan 2010; however no results were reported. Treatment included amantadine, Nuvigil, Adderall XL. The reporter assessed this case as serious due to permanent disability and the final outcome was reported as condition unchanged. No further information was provided. Based on the investigation performed, QA department stated that, the S-OIV FLUVIRIN (batch number: 101716P1A) was manufactured in accordance with the approved internal procedures and it is in compliance with the cGMP requirements. Follow-up received from Quality Assurance Department (reference number: 209251) on 18 May 2014: Updated batch review report.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Blood pressure abnormal, Dizziness, Immediate post-injection reaction, Injection site induration, Injection site mass
Clinical narrative: Case number PHHY2012US110835 is an initial spontaneous report from a health care professional via Vaccine Adverse Event Reporting System (VAERS reference number 465990) received on 04 Dec 2012 with a follow-up received from Quality Assurance Department (reference number: 209633) on 18 May 2014. This report refers to a 52-year-old female patient. The patient's medical history included low blood pressure and atypical migraines (aura). The patient was vaccinated with FLUVIRIN (batch number 12263P) intramuscularly in her left arm on 19 Sep 2012. On 19 Sep 2012 immediately after vaccination a hard lump at the injection site developed into left deltoid. She was instructed to sit and wait for 15-20 minutes for observation and to make sure no further reaction developed. Upon walking to waiting area, she became light-headed and wanted to lie down. As she was being helped to bench where she could lay down, she fainted. She was given ammonia salts and blood pressure was taken (116/83, pulse 64). She was alert and responsive throughout this whole time. She was then given water and stated that she was feeling better and wanted to attempt to sit up. Upon sitting, patient stated she began to feel light-headed again. Her blood pressure was taken at this time and it was 93/65, pulse 66. A co-worker grabbed a bag of Fritos to give to patient to try to bring her blood pressure (something salty). She continued to eat and drink while lying down and blood pressure was taken again (118/84, pulse 65). After a few minutes of sitting, blood pressure was taken and it was 84/57, pulse 66. At this time, patient reported seeing spots in her vision. She related this to how she felt sometimes when she had atypical migraines (aura). Her blood pressure was again taken while sitting and it was 95/74, pulse 67, so she was laid back down again. When it became apparent that patient's blood pressure was not holding upon sitting EMS was called. By the time they arrived approximately 45 minutes had elapsed since the injection and approximately 30 minutes since patient had fainted. EMS spoke to the patient, took her blood pressure, and found it holding around 100/75. She reported feeling much better and no longer seeing spots. The patient was followed up on 21 Sep 2012; she reported feeling much better with no residual or returning symptoms. She called her doctor and informed him of the episode but did not receive any additional instructions. The seriousness and causality assessment of the events was unknown. Based on the batch investigation performed, QA department stated that, the FLUVIRIN (batch number: 12263P) was manufactured in accordance with the approved internal procedures and it is in compliance with the cGMP requirements. Non-significant follow-up received from Quality Assurance Department (reference number: 209633) on 11 Feb 2013: Updated QA reference number only. Follow-up received from Quality Assurance Department (reference number: 209633) on 18 May 2014: Updated batch review report.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Syncope, Visual impairment
Clinical narrative: Case number PHHY2012US110835 is an initial spontaneous report from a health care professional via Vaccine Adverse Event Reporting System (VAERS reference number 465990) received on 04 Dec 2012 with a follow-up received from Quality Assurance Department (reference number: 209633) on 18 May 2014. This report refers to a 52-year-old female patient. The patient's medical history included low blood pressure and atypical migraines (aura). The patient was vaccinated with FLUVIRIN (batch number 12263P) intramuscularly in her left arm on 19 Sep 2012. On 19 Sep 2012 immediately after vaccination a hard lump at the injection site developed into left deltoid. She was instructed to sit and wait for 15-20 minutes for observation and to make sure no further reaction developed. Upon walking to waiting area, she became light-headed and wanted to lie down. As she was being helped to bench where she could lay down, she fainted. She was given ammonia salts and blood pressure was taken (116/83, pulse 64). She was alert and responsive throughout this whole time. She was then given water and stated that she was feeling better and wanted to attempt to sit up. Upon sitting, patient stated she began to feel light-headed again. Her blood pressure was taken at this time and it was 93/65, pulse 66. A co-worker grabbed a bag of Fritos to give to patient to try to bring her blood pressure (something salty). She continued to eat and drink while lying down and blood pressure was taken again (118/84, pulse 65). After a few minutes of sitting, blood pressure was taken and it was 84/57, pulse 66. At this time, patient reported seeing spots in her vision. She related this to how she felt sometimes when she had atypical migraines (aura). Her blood pressure was again taken while sitting and it was 95/74, pulse 67, so she was laid back down again. When it became apparent that patient's blood pressure was not holding upon sitting EMS was called. By the time they arrived approximately 45 minutes had elapsed since the injection and approximately 30 minutes since patient had fainted. EMS spoke to the patient, took her blood pressure, and found it holding around 100/75. She reported feeling much better and no longer seeing spots. The patient was followed up on 21 Sep 2012; she reported feeling much better with no residual or returning symptoms. She called her doctor and informed him of the episode but did not receive any additional instructions. The seriousness and causality assessment of the events was unknown. Based on the batch investigation performed, QA department stated that, the FLUVIRIN (batch number: 12263P) was manufactured in accordance with the approved internal procedures and it is in compliance with the cGMP requirements. Non-significant follow-up received from Quality Assurance Department (reference number: 209633) on 11 Feb 2013: Updated QA reference number only. Follow-up received from Quality Assurance Department (reference number: 209633) on 18 May 2014: Updated batch review report.
Age: 84.0
Sex: F
Vaccine: FLU3
Symptoms: Bone pain, Injected limb mobility decreased, Injection site bruising, Injection site reaction
Clinical narrative: Case number PHHY2012US111625 is an initial report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 467743) on 04 Dec 2012, with the follow-up received from Quality Assurance Department (reference number: 209992) on 18 May 2014. This report refers to an 84-year-old female patient. The patient's preexisting conditions included arthritis in her neck. The patient was vaccinated with FLUVIRIN (batch number: 1206701) intramuscularly in left arm on 21 Sep 2012. On the same day of vaccination, the patient experienced bruise on upper left shoulder with complaints of difficulty raising and moving the arm. The patient also complained shoulder bone pain. Pharmacist on duty recommended warm moist heat and BENGAY when not using heat. Outcome of the events was reported as not recovered at the time of this report. Seriousness and causality of the events were not reported. Based on the investigation performed, QA department stated that, the FLUVIRIN (batch number: 1206701) was manufactured in accordance with the approved internal procedures and it is in compliance with the cGMP requirements. Follow-up received from Quality Assurance Department (reference number: 209992) on 18 May 2014: Updated batch review report.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal discomfort, Blood pressure increased, Diarrhoea, Eye pain, Feeling hot
Clinical narrative: Case number PHHY2012US111628 is an initial report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 467745) on 04 Dec 2012 with a follow-up information received from the quality assurance department (QA reference number: 209993) on 18 May 2014: This report refers to a 65-year-old female patient. The patient's current illness included thyroid disease. Historical drugs included TORADOL, CIPRO, SEPTRA, DEMEROL, AUGMENTIN, erythromycin, codeine and iodine. The patient was vaccinated with FLUVIRIN (batch number: 1204301, expiry date: 31 May 2013) intramuscularly in left arm on 03 Oct 2012. About 1 hour post flu shot administration, patient experienced hot sensation starting from injection site radiating throughout the rest of the body. Other symptoms included blurry vision, eye pain, severe headache, nausea, upset stomach and diarrhea. The patient's blood pressure (BP) elevated to 174/105. Outcome of the events was reported as recovered on an unknown date. Seriousness and causality of the events were not reported. Upon follow up receipt from the quality assurance department (reference number: 209993), it was reported that based on the documents review, the FLUVIRIN batch was manufactured in accordance with the approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. No additional information was available. Follow up information received from the quality assurance department on 18 May 2014: Batch summary and expiry date updated.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Injection site reaction, Nausea, Vision blurred
Clinical narrative: Case number PHHY2012US111628 is an initial report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 467745) on 04 Dec 2012 with a follow-up information received from the quality assurance department (QA reference number: 209993) on 18 May 2014: This report refers to a 65-year-old female patient. The patient's current illness included thyroid disease. Historical drugs included TORADOL, CIPRO, SEPTRA, DEMEROL, AUGMENTIN, erythromycin, codeine and iodine. The patient was vaccinated with FLUVIRIN (batch number: 1204301, expiry date: 31 May 2013) intramuscularly in left arm on 03 Oct 2012. About 1 hour post flu shot administration, patient experienced hot sensation starting from injection site radiating throughout the rest of the body. Other symptoms included blurry vision, eye pain, severe headache, nausea, upset stomach and diarrhea. The patient's blood pressure (BP) elevated to 174/105. Outcome of the events was reported as recovered on an unknown date. Seriousness and causality of the events were not reported. Upon follow up receipt from the quality assurance department (reference number: 209993), it was reported that based on the documents review, the FLUVIRIN batch was manufactured in accordance with the approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. No additional information was available. Follow up information received from the quality assurance department on 18 May 2014: Batch summary and expiry date updated.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Flushing, Nervousness, Pruritus, Urticaria
Clinical narrative: Case number PHHY2012US111687 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 467806) website on 04 Dec 2012 with a follow up report received from the Quality Assurance department (QA reference number: 210002) on 18 May 2014. This report refers to a 52 year old female patient. Her medical history and concomitant medication were not reported. She was vaccinated with FLUVIRIN (batch number: 122204, expiry date: 31 May 2013) intramuscularly in to the right arm on 02 Oct 2012. Thirty minutes after receiving influenza vaccine, she began having itching, face flushing, hives and nervousness. BENADRYL and epinephrine were administered. Outcome was reported as complete recovery. No further information about seriousness and causality was reported. Based on the review performed, it was concluded that this batch of FLUVIRIN; batch number: 122204 was manufactured in accordance with approved internal procedures and was in compliance with cGMP requirements. Follow up report was received from the Quality Assurance department on 18 May 2014: The expiry date of FLUVIRIN, EMEA labeling for the events and the batch review report were updated.
Age: 33.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Syncope
Clinical narrative: Case number PHHY2012US111766 is an initial report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 468242) website on 04 Dec 2012 with a follow up report received from Quality Assurance Department (QA, reference number: 209979) on 18 May 2014. This report refers to a 33-year-old male patient. His current condition included slight sickness and a history of "fainting with needles". Concomitant medication was not reported. He was vaccinated with FLUVIRIN (batch number: 1205301, expiry date: Jun 2013) intramuscularly into his right arm and BOOSTRIX (other manufacturer, batch number: AC52B092EA) intramuscularly into his left arm on 29 Sep 2012. A few seconds after vaccination, he fainted and within a minute he started to wake up. After 15 minutes patient was fully recovered. No further information was available. Based on the batch review performed, it was concluded that the FLUVIRIN batch number: 1205301 was manufactured in accordance with the approved internal procedures and in compliance with the cGMP requirements. Follow up report received on 18 May 2014: Updated vaccine expiry date and batch review report.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Dizziness, Pruritus
Clinical narrative: Case number PHHY2012US111771 is an initial report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 468249) website on 04 Dec 2012 with internal review on 19 Dec 2012 of the data received on 04 Dec 2012 with a follow up information received from the quality assurance department (QA reference number: 209973) on 18 May 2014. This report refers to 29-years-old female patient. Her current condition included urinary tract infection (no fever) and concomitant medication included COMPAZINE, doxycycline, erythromycin, iodine, MAXALT, NSAIDs, penicillin, REGLAN, ROCEPHIN, TORADOL, tramadol and ULTRAM. She was vaccinated with FLUVIRIN (batch number: 123102, expiry date: 30 Jun 2013) in the left arm on 04 Oct 2012. On the same day after vaccination, she experienced itching, tightness in chest and dizziness. The outcome of the events was reported as completely recovered as of 07 Oct 2012. The causality and seriousness of the events was not reported. Upon follow up receipt from the quality assurance department (reference number: 209973), it was reported that based on the documents review, the FLUVIRIN batch was manufactured in accordance with the approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. No trends or deviations were noted for this batch which were suspected to link to the symptoms seen by the patient. Following internal review on 19 Dec 2012 of data received on 04 Dec 2012: Following significant correction was done, the case upgraded from non-serious to serious (medically significant) for chest tightness. Follow up information received from the quality assurance department (QA reference number: 209973) on 18 May 2014: Batch summary and expiry date of suspect vaccine updated.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Eye pain, Facial pain, Lip swelling, Myalgia, Oral herpes
Clinical narrative: Case number PHHY2012US111809 is an initial report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 468517) website on 04 Dec 2012 with a follow up report received from Quality Assurance Department (QA, reference number: 209815) on 18 May 2014. This report refers to a 57-year-old female patient. Her historical conditions and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 12241P) intramuscularly to her left arm on 08 Oct 2012. On 09 Oct 2012 at 3.00 am she woke up with generalized muscle aches, a large fever, blister (swollen) on top lip and sharp pain in the cheek or eye area. Patient took ibuprofen to reduce the lip swelling. Pharmacist advised her to consult a doctor. Outcome of the event was reported as not recovered. Based on the batch review performed, it was concluded that FLUVIRIN batch number: 12241P was manufactured in accordance with the approved internal procedures and in compliance with the cGMP requirements. Follow up report received on 18 May 2014: Updated batch review report and QA reference number.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Hypersensitivity, Hypotension, Pain, Rash
Clinical narrative: Case number PHHY2012US111817, is an initial report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 468533) website on 04 Dec 2012 with follow-up received from Quality Assurance department (QA ref: 209816) on 18 May 2014. This report refers to a 46-year-old female patient. The patient had the seasonal flu vaccine for the following years: 2009/10, 2010/11 and 2011/12 and had reactions (unspecified) from flu vaccine. She was vaccinated with FLUVIRIN (batch number: 1205001) intramuscularly to her left arm on 05 Oct 2012. Vaccine was administered at the place of employment. On 09 Oct 2012, four days after vaccination, the patient had an allergic reaction to the flu shot. She was feeling weak, body aches and fainted at the Doctor's office with a blood pressure of 70/40. Her "PCP" recommended hospitalization for those symptoms and including a rash she was developing. It was also reported that the patient was being hospitalized due to reactions. Outcome of the events were reported as not recovered. Based on the investigation performed by the QA department, it was confirmed that FLUVIRIN batch number 1205001 was manufactured in accordance with the effective company procedure and was in compliance with corporate quality requirements. Non-significant follow-up received from QA department on 11 Feb 2013: Updated QA reference number as 209816. Follow-up received from QA department on 18 May 2014: Updated batch review report.