chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Case previously recorded as MA2009-3987. Initial case report received from a nurse via MedCom. on 09 NOV 2009. A 3 year-old male patient was inadvertently vaccinated i.m with S-OIV FLUVIRIN (batch no. 1008132P) on 03 NOV 2009. No adverse events were reported. MedCom reference no.: NA09-007806.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Accidental exposure, Eye irrigation, No adverse event
Clinical narrative: Case previously recorded as MA2009-3999. Initial case report received from a physician, via Novartis Medical Communications, on 10 NOV 2009. A nurse had S-OIV FLUVIRIN (batch no. 102042P1) sprayed into the eye while withdrawing a dose from the MDV. The nurse is not experiencing any eye irritation, redness or pain. The eye was rinsed with water. No adverse event was reported. MedCom reference no.: NA09-007930.
Age: 2.0
Sex: M
Vaccine: FLU3
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Case previously recorded as MA2009-4003. Initial case report received from a nurse via Novartis Pharma, on 11 Nov 2009. A 3-year-old patient was vaccinated with 0.25 mL of FLUVIRIN (batch no. 1009235P) i.m., on 10 Nov 2009. No adverse events was reported. Company assessment: not serious. Seriousness criterion: not serious. Causality: not applicable. Expectedness assessment according to agency: Administration to a child under 4-year-old is unexpected with FLUVIRIN. No change in benefit-risk-ratio. No measures necessary. Agency reference no.: NA09-007988.
Age: 2.0
Sex: M
Vaccine: FLU3
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Case previously recorded as MA2009-4004. Initial case report received from a nurse via Novartis Pharma on 11 NOV 2009. A 2-year-old boy was vaccinated with S-OIV FLUVIRIN (batch no. 1009235P) i.m., on 10 NOV 2009. No adverse event was reported. MedCom reference no.: NA09-007988.
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Case previously recorded as MA2009-4037. Initial case report received from a nurse via MedCom on 10 NOV 2009. A patient 3-year-old male was vaccinated with S-OIV FLUVIRIN (batch no. 102044P1) i.m on 10 NOV 2009. No adverse effect was reported. MedCom reference no.: NA09-007935.
Age: 10.0
Sex: M
Vaccine: FLU3
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Case previously recorded as MA2009-4052. Initial case report received from a physician via MedCom on 11 NOV 2009. A 10 year-old male patient was vaccinated with S-OIV FLUVIRIN (batch no. unknown) i.m into the right deltoid on 10 NOV 2009 and was accidentally given S-OIV FLUVIRIN (batch no. 102045P1) i.m. on the right deltoid again on 11 NOV 2009. No adverse events were reported. MedCom reference no.: NA09-007995.
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Case previously recorded as MA2009-4055. Initial case report received from a physician via MedCom, on 11 NOV 2009. A 3-year-old male patient was accidentally vaccinated with S-OIV FLUVIRIN (batch no. 10127601) i.m. on 11 NOV 2009. No adverse effect was reported. MedCom reference no.: NA09-008017.
Age: 0.5
Sex: F
Vaccine: FLU3
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Case previously recorded as MA2009-4057. Initial case report received from a nurse, via Novartis Medical Communication, on 11 NOV 2009. A 6 month-old female patient was vaccinated with 0.25 ml of S-OIV FLUVIRIN (batch no. 102042P1) i.m. on 11 NOV 2009, an off-label indication. No adverse event was reported. MedCom reference no.: NA09-008013.
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Case previously recorded as MA2009-4068. Initial case report received from a physician via Novartis Pharma on 09 NOV 2009. A 3-year-old male patient was vaccinated with 0.5 mL of S-OIV FLUVIRIN (batch no. 1008143P) i.m., on 06 NOV 2009. MedCom reference no.: NA09-007849.
Age: 0.64
Sex: F
Vaccine: FLU3
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Case previously recorded as MA2009-4069. Initial case report received from a physician via MedCom on 09 NOV 2009. A patient 8-month-old female was vaccinated with S-OIV FLUVIRIN (batch no. 1008143P) 0.5mL i.m on 06 NOV 2009. No adverse event was reported. MedCom reference no: NA09-007849.
Age: 0.04
Sex: F
Vaccine: FLU3
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Case previously recorded as MA2009-4070. Initial case report received from a physician via MedCom on 09 NOV 2009. A 13 day-old female patient was inadvertently administered with 0.5 mL i.m. S-OIV FLUVIRIN (batch no. 1008143P) on 06 NOV 2009. No adverse events were reported. MedCom reference no.: NA09-007849.
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Case previously recorded as MA2009-4071. Initial case report received from a physician on 09 NOV 2009. A 3-year-old male patient was accidentally vaccinated with FLUVIRIN (batch no. 10127601) i.m. on 06 NOV 2009. No adverse effect was reported. Reference no: NA09-007849.
Age: 3.0
Sex: F
Vaccine: FLU3
Symptoms: Inappropriate schedule of drug administration, No adverse event, Off label use
Clinical narrative: Case previously recorded as MA2009-4072. Initial case report received from a physician, via Novartis Medical Communication on 09 NOV 2009. A 3-year-old female patient was vaccinated with 0.5 ml of S-OIV FLUVIRIN (batch no. 1008143P) i.m. on 06 NOV 2009. No adverse event was reported. MedCom reference no.: NA09-007849.
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Case previously recorded as MA2009-4073. Initial case report received from a physician via Novartis Pharma on 10 NOV 2009. A 3-year-old male patient was vaccinated with 0.5 mL of S-OIV FLUVIRIN (batch no. 1008143P) i.m., on 06 NOV 2009. MedCom reference no.: NA09-007849.
Age: 2.0
Sex: F
Vaccine: FLU3
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Case previously recorded as MA2009-4084. Initial case report received from a nurse via MedCom on 09 NOV 2009. A patient 2-year-old female was vaccinated with 0.5mL S-OIV FLUVIRIN (batch no. 1009225PA) once i.m. on 09 NOV 2009. No adverse event was reported. MedCom reference no.: NA09-007868.
Age: 0.57
Sex: M
Vaccine: FLU3
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Case previously recorded as MA2009-4085. Initial case report received from a nurse on 09 NOV 2009. A 6-month-old male patient was vaccinated with 0.5 mL FLUVIRIN (batch no. 1009225PA) i.m into the thigh on 09 NOV 2009. No adverse events were reported. Reference no: NA09-07868.
Age: 1.68
Sex: F
Vaccine: FLU3
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Case previously recorded as MA2009-4086. Initial case report received from a physician on 09 NOV 2009. A 1-year-old female patient was accidentally vaccinated with FLUVIRIN (batch no. 1009225PA) i.m. into the thigh on 09 NOV 2009. No adverse effect was reported. Reference no: NA09-007868.
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Inappropriate schedule of drug administration, No adverse event, Off label use
Clinical narrative: Case previously recorded as MA2009-4153. Initial case repot received from a physician on 11 NOV 2009. A 3-year-old male patient was vaccinate with 0.5 ml of FLUVIRIN (batch no. 1008146P) i.m. on 05 NOV 2009, an off label indication. No adverse event was reported. Reference no: NA09-007993.
Age: 2.0
Sex: M
Vaccine: FLU3
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Initial physician report was received on 04 Dec 2009: This patient was vaccinated with FLUVIRIN, batch number 102041P1 on 04 Dec 2009. The patient (2 years of age) was inadvertently administered FLUVIRIN. No adverse event was noted after administration.
Age: 1.5
Sex: F
Vaccine: FLU3
Symptoms: Inappropriate schedule of drug administration, Influenza like illness, Pyrexia
Clinical narrative: Initial report was received from a consumer on 04 DEC 2009. This patient (18 month old child) was vaccinated with FLUVIRIN (batch no: unknown) on an unknown date. The patient was experienced with fever and flu like illness on 30 NOV 2009. The outcome of the events were reported as fully recovered.
Age: 1.17
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Initial report received from a physician on 04 Dec 2009: This patient, who was below the age of 4 years, received FLUVIRIN 0.5 ml intramuscular, batch no.: 102130P1, on 25 Nov 2009. No adverse event was reported.
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pruritus, Swelling face
Clinical narrative: Initial report received from a health care professional on 18 Dec 2009: This patient was vaccinated with FLUVIRIN 0.5 ml, intramuscular, on 17 Dec 2009. On 17 Dec 2009, fifteen minutes after she received the vaccination, she experienced face swelling and pain with itching in her head. She went to emergency room and was treated and released. The outcome of the event was reported as resolved in less than 24 hours.
Age: 22.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Dizziness, Headache, Visual impairment
Clinical narrative: Initial report received from a health care professional on 18 Dec 2009: This patient was vaccinated with S-OIV FLUVIRIN (batch no. 10073804) on 15 Dec 2009. The patient experienced bad headache after 1 hour and felt dizzy with vision problems after 5 hours of vaccination on 15 Dec 2009. The events resolved on 16 Dec 2009. Outcome of the events was reported as complete recovery.
Age: 65.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Contusion, Flushing, Injection site induration, Injection site mass
Clinical narrative: Initial report received from a health care professional on 08 Dec 2009: The patient received treatment with FLUVIRIN, subcutaneous, on 02 Dec 2009. On 02 Dec 2009, the patient's vaccine injection site became hard with an egg size hard lump in left arm accompanied with flushed feeling, bruising and was sent to emergency prompt care. The patient received treatment with ZANTAC 150 mg and BENADRYL 25 mg, on an unspecified date. On 08 Dec 2009, the patient recovered from the large egg size lump. The outcome of bruise and feeling flushed were reported as recovering. The causality of the events were not reported.
Age: 2.0
Sex: U
Vaccine: FLU(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Initial report received from a health care professional on 21 Dec 2009: This patient (2 year old child) was vaccinated with S-OIV FLUVIRIN (batch no. unknown) on 21 Dec 2009. No adverse event was reported.
Age: 2.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Initial report received from health care professional on 04 Dec 2009: This patient (under the age of 4 years) was vaccinated with FLUVIRIN 0.50 ml, intramuscular, on 04 Dec 2009. No adverse effect were noted after administration.
Age: 3.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Initial report received from a health care professional on 10 Dec 2009: This patient, 37 months old boy, inadvertently received on dose of S-OIV FLUVIRIN in a pre filled syringe on 09 Dec 2009.
Age: 9.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: Initial report received from a health care professional on 18 Dec 2009: This patient was vaccinated with FLUVIRIN (batch no. 1013262P) via intranasal route instead of intramuscular route on 17 Dec 2009. No adverse event was reported.
Age: 2.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Initial report received from health care professional on 17 Dec 2009: This patient was vaccinated with FLUVIRIN 0.25 ml, intramuscular, on unknown date. The vaccine was inadvertently given to 2 years old. No adverse effect were noted after administration.
Age: 3.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Initial report was received from a nurse on 04 Dec 2009: This patient (age less than 04 years) inadvertently received a FLUVIRIN 0.5 ml, intramuscular on 04 Dec 2009. No adverse events were reported.
Age: 2.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Initial report received from physician on 17 Dec 2009: A 2 years old child was administered with FLUVIRIN on 16 Dec 2009. No adverse event was reported.
Age: 1.29
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Initial report was received from a health care professional on 18 Dec 2009: This patient (15 month old) was inadvertently given S-OIV FLUVIRIN batch no: 101329ZP, 0.5 ml, intramuscular on 17 Dec 2009. No adverse events were reported.
Age: 8.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Initial report received from a nurse on 10 Dec 2009: This patient received initial vaccination with FLUVIRIN (batch no 102136P1A) on 20 Nov 2009. The second dose was give on 03 Dec 2009 which was only fourteen days after the first dose. No adverse event was reported.
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Initial case was received from a nurse on 30 Dec 2009: This patient was received FLUVIRIN (batch no 102141P1) on an unknown date. He was injected into the thigh of a him, who was younger than 4 years. No adverse effect was reported. The case was assessed as not serious by the reporter. Significant case correction following internal review on 19 Jan 2010 of the data received on 30 Dec 2009: The event was recoded to off label use from earlier coded event inappropriate age at vaccine administration and PI labeling was added.
Age: 1.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Initial report received from a health care professional on 31 Dec 2009: This patient, with an unknown medical history was inadvertently administered FLUVIRIN, intramuscularly on an unspecified date. The outcome of the event was not reported. No other information was provided.
Sex: F
Vaccine: FLU3
Symptoms: Device leakage, No adverse event
Clinical narrative: Initial report received from a registered nurse on 31 Dec 2009: This patient received S-OIV FLUVIRIN multi dose, 0.5 ml on an unspecified date. It was reported that, the reporter used a non-Novartis Vaccine and diagnostics syringe and needle and inserted the needle with attached syringe into patient's deltoid. When the reporter was vaccinating, she noted that vaccine ran down the patient's arm. It was reported that, the reporter did not know whether there was a crack in the syringe or needle became loose or something else happened to allow vaccine to leak. No adverse events was reported.
Sex: U
Vaccine: FLU(H1N1)
Symptoms: Rash maculo-papular
Clinical narrative: Initial report received from a physician on 31 Dec 2009: This patient was received FLUVIRIN on an unknown date. The patient had macular papular rash in Oct 2004. The patient hadn't had an influenza vaccination since that time. MD was attempting to rule out possibilities. Explained to MD that FLUVIRIN was not released on the market that year. The outcome of the event was not reported.
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Initial report received from a nurse on 30 Dec 2009. The patient (a boy younger than 4 years) was vaccinated with FLUVIRIN (batch no: 102147P1) 0.25 ml on an unknown date. No adverse events were reported.
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Initial report received from nurse on 30 Dec 2009: This patient was vaccinated with FLUVIRIN 0.25 ml, intramuscular, on an unknown date. The vaccine was injected into the thigh of the baby younger than 4 years. No adverse effect were noted after administration. The outcome of event was not reported.
Age: 3.0
Sex: F
Vaccine: FLU3
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Initial case report received from a nurse via MedCom on 23 OCT 2009. A 3-year-old female patient, was vaccinated with FLUVIRIN (batch no UT3178DA) i.m. into the left deltoid on an unknown date. Attempted to confirm lot number. The caller stated that the product administered was FLUVIRIN. No adverse event was reported. Reference no. NA09-006928. Follow-up information received on 04 Jan 2010: Batch no. for FLUVIRIN was reported as UT3178DA.
Age: 31.0
Sex: M
Vaccine: FLU3
Symptoms: Musculoskeletal stiffness
Clinical narrative: Initial report received from HCP on 27 Dec 2009. The patient was vaccinated with FLUVIRIN, (batch no: unknown) on an unknown date. The patient experienced stiffness that started behind the right ear that radiated to the right side of the neck approximately 30mins post vaccination and lasted about 24hrs. The outcome of the event was not reported.
Age: 88.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect route of drug administration, Joint effusion
Clinical narrative: On 04 OCT 2009 we received from a health care professional the following information: A male patient, born on 26 May 1921, was vaccinated with 0.5 ml FLUVIRIN subcutaneously in SEP 2009. On 30 SEP 2009 the patient experienced fluid pooling at elbow and wrong route of vaccination (subcutaneously). He had not recovered at time of the report. No: NA09-005090. This case was previously reported as MA2009-2841. Follow up report received on 19 Jan 2010: It was reported that there might have been an issue with muscle mass and the reporter not sure of specifications of pooling. The reporter stated that the patient was fine. Follow up report received on 12 Apr 2010: It was reported that PRA tried to contact the reporter twice without any response so far. No further information was expected and case will be closed. Following internal review of the data on 14 Apr 2010, the case PHHY2009US61202 was identified as a duplicate of this case PHHY2009US60509. The case PHHY2009US61202 will be deactivated.
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Diarrhoea, Dysgeusia
Clinical narrative: We received the following information for a Novartis Vaccines and Diagnostics employee on 06 NOV 2009: A male patient was vaccinated with H1N1 (batch number or manufacturer unknown) on 30 OCT 2009. The patient has ever had diarrhea since then. He was scheduled to have a stool sample examined by his health care provider on 07 NOV 2009. This case was previously reported as MA2009-3773. Follow up information via e-mail from consumer received on 20 Jan 2010: The patient developed mettalic taste in the mouth. He felt better after few days; so, he never had in a stool sample examination. No other new information was reported. Follow up report received via e-mail from consumer on 22 Feb 2010: The patient reported that he was feeling very well, since he received the H1N1 vaccine. The patient had diarrhea and was about to submit stool sample to the health care provider, but the symptoms went away after a few days (exact date not specified).
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Headache, Nasopharyngitis, Oropharyngeal pain, Pain
Clinical narrative: Initial case report received from a consumer via Novartis Medical Communications on 05 NOV 2009. A male patient (age unknown) was vaccinated for the first time with S-OIV FLUVIRIN (batch no. 9721502, expiration date JUN 2010) on 27 OCT 2009. On an unknown date, the patient experienced sore throat, headache, cold and body aches. At the time of this report, the outcome of the events was reported as unknown. This case was previously reported as MA2009-3820. Follow up information received on 21 Jan 2010. It was reported that the outcome of the events were complete recovery. No further information reported at the time of the report.
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Accidental exposure, No adverse event
Clinical narrative: Initial report received from nurse (patient) as quality complain on 20 Nov 2009: The nurse had problem of leakage with 10 units of H1N1 (batch no. 102040P1). She reported that vaccine ran down her hand and down her arm. No adverse event was reported. Following an internal review done on 05 Feb 2010 of the data received on 20 Nov 2009 following corrections made: The event coding was changed.
Age: 1.51
Sex: M
Vaccine: FLU3
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Initial case report received from a physician via MedCom on 19 OCT 2009. A male patient was vaccinated with S-OIV FLUVIRIN (batch no. 102124P1) i.m. on 13 OCT 2009. No adverse events were reported. MedCom reference no.: NA09-008308. This case was earlier reported as MA2009-5163. Follow up received on 04 Feb 2010: The patient's demographics was amended.
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Body temperature increased, Cough, Influenza like illness, Oropharyngeal pain
Clinical narrative: A consumer (and health care professional) reported the following information via Novartis on 5 NOV 2009: An 11-year-old female patient was vaccinated with a pandemic H1N1-influenza vaccine (batch no. unknown) on 31 OCT 2009. She experienced flu like disease (elevated temperature up to 37.9 C, sore throat and cough) on 1 NOV 2009 persisting for four days. She had recovered at reporting date. Her father was also vaccinated. Please see case MA2009-3704 and MA2009-3705. This case previously recorded as MA2009-3705. Follow up received from a consumer on 03 Feb 2010: The outcome of events were reported fully resolved after approximate 3 days. This case previously also recorded as MA2009-3704. Follow up received from the consumer on 04 Mar 2010: A Co-suspect vaccine was coded as Influenza virus vaccine pandemic which the patient received on 23 Oct 2009.
Age: 11.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Body temperature increased, Cough, Influenza like illness, Oropharyngeal pain
Clinical narrative: A consumer (and health care professional) reported the following informationvia Novartis on 5 NOV 2009: An 11-year-old female patient was vaccinated with H1N1 (batch no. unknown) on 31 OCT 2009. She experienced flu like disease (elevated temperature up to 37.9 C, sore throat and cough) on 1 NOV 2009 persisting for four days. She had recovered at reporting date. Her father was also vaccinated. Please see cases MA2009-3704 and MA2009-3705. This case was initially reported as MA2009-3707. Follow up information received from consumer on 03 Feb 2010: No new medical information was received.
Age: 3.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Initial report received from a health care professional on 09 Dec 2009: It was reported that a 3 year old patient received 0.5 ml dose of FLUVIRIN inadvertently on 07 Dec 2009. The outcome of the event was not reported. No further information was provided.
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Drug administration error, No adverse event
Clinical narrative: Initial health care professional report received on 15 Dec 2009: This patient received one dose of FLUVIRIN (batch no: 102139P1) 0.5 mL intramuscularly into the deltoid on 15 Dec 2009. Once the needle was withdrawn from the tissue, the reporter noticed that a small, unspecified volume of vaccine ran down the patient's arm. No adverse event was reported. No other information was available.
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Injection site discharge, No adverse event
Clinical narrative: Initial consumer report received on 18 Dec 2009: This patient received one dose of FLUVIRIN (batch no: 102046P1) intramuscularly on an unknown date. The reporter stated that she saw some liquid came out in the air after the needle was pulled out of her arm. She stated that liquid was from the injection site once the needle was removed. She was vaccinated with a dose from the MDV. No adverse event was reported. No other information was available.
Age: 1.5
Sex: F
Vaccine: FLU3
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Initial report was received from a health care professional on 18 Dec 2009: This patient (18 month old) was inadvertently given FLUVIRIN 0.5 ml, intramuscular on an unknown date. No adverse events were reported.
Age: 3.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Initial nurse report received on 15 Dec 2009: This patient received one dose of FLUVIRIN (batch no: 102131P1) intramuscularly on 15 Dec 2009. No adverse event was reported. No other information was available.
Age: 6.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Fatigue, Hypersomnia, Somnolence
Clinical narrative: Initial report received from a consumer (acquaintance of the patient) on 03 Dec 2009: This patient with medical history of Seasonal vaccination, sick and low grade fever, received Influenza virus vaccine-Pandemic INN on 01 Dec 2009. The patient experienced much more sleep than common, needed extra two hours sleep than usual eleven hours per night, uncharacteristic sleepiness and tiredness on an unspecified date. It was reported that, the reporter was not sure about whether the vaccination caused the events or the pre-historical conditions. The outcome of the events was not reported.
Age: 3.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Initial report from the nurse received on 16 Dec 2009: The patient (3 year old) had received with FLUVIRIN on an unknown date. No further information reported at the time of the report.
Age: 1.1
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Initial report received from the nurse on 15 Dec 2009. The infant received FLUVIRIN 0.25 ml on 13 Dec 2009. No further information reported at the time of the report.
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Drug administration error, No adverse event
Clinical narrative: Initial report received from health care professional on 15 Dec 2009: One dose of S-OIV FLUVIRIN was drawn into syringe. This syringe with attached needle was used to inject 0.5 ml dose of S-OIV FLUVIRIN (batch no. 102139P1) into the deltoid of this patient on 15 Dec 2009. Once the needle was withdrawn from the tissue, the reporter noticed that a small, unspecified volume of vaccine ran down the patient's arm. No adverse effect was reported.
Age: 0.2
Sex: U
Vaccine: FLU(H1N1)
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Initial report from the pharmacist received on 15 Dec 2009: This neonate received 0.25ml dose of FLUVIRIN on 09 Dec 2009. No further information reported at the time of the report.
Age: 64.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Syringe issue
Clinical narrative: Initial consumer report received on 15 Dec 2009: It was reported that the patient had received with FLUVIRIN on an unknown date and while giving vaccine in right deltoid, the plastic syringe began to bend and leaked down her arm and leg. The patient was administered another 0.25ml dose by the nurse. No further information reported at the time of the report.
Age: 1.4
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Initial report was received from a health care professional on 15 Dec 2009: This patient (17 month old child) inadvertently received FLUVIRIN 0.25 ml, dose intramuscular on an unknown date. No adverse event was reported.
Age: 76.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Initial information received from other healthcare professional on 15 Dec 2009: The caller stated that the patient may have received a second dose of S-OIV FLUVIRIN. The caller stated that the patient believed that he received vaccine "one month ago" but was unsure if it was H1N1 or seasonal. No adverse event was reported. No other information was provided.
Age: 2.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Initial information received from a healthcare professional on 16 Dec 2009: The reporter stated that a 2 year old child received a dose of FLUVIRIN (batch no. 102133P1) on 15 Dec 2009. No adverse reaction had occurred.
Age: 1.15
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Initial health care professional report received on 15 Dec 2009: This child was vaccinated intramuscularly with FLUVIRIN (batch no: 102143P1) 0.5 mL on 12 Dec 2009. No adverse event was reported. No more information was available.
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Initial report received from a pharmacist on 22 Dec 2009: This patient received S-OIV FLUVIRIN (batch no. 102134P1) on 22 Dec 2009. The patient experienced numbness and tingling "across the body" after 3 hours of vaccination on 22 Dec 2009. The events were ongoing and final outcome of the events was reported as conditioned unchanged.
Age: 22.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Drug exposure during pregnancy, Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Initial report received from a nurse on 22 Dec 2009: This pregnant patient was vaccinated first time with S-OIV FLUVIRIN (batch no: 1008131P) on 21 Oct 2009. A second dose of FLUVIRIN was administered on 02 Nov 2009. No adverse event was reported.
Age: 1.15
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Initial report received from a medical assistant on 15 Dec 2009: This infant patient received FLUVIRIN batch number 102143P1, 0.5 ml intramuscular on 12 Dec 2009. No adverse event was reported.
Age: 1.12
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Initial health care professional report received on 09 Dec 2009: This child was inadvertently received 0.5 mL IM dose of FLUVIRIN (batch no: 102128P1) on 08 Dec 2009. No adverse event was reported. No more information was available.
Age: 1.66
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Initial healthcare professional report received on 18 Dec 2009: This patient (one year old child) was vaccinated with S-OIV FLUVIRIN (batch no. 102124P1) on 18 Dec 2009. No adverse event was reported.
Age: 77.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Abdominal pain upper, Asthenia, Burning sensation, Hyperhidrosis, Musculoskeletal chest pain
Clinical narrative: Initial report received from a healthcare professional on 22 Dec 2009: This patient was vaccinated with S-OIV FLUVIRIN (batch no. 102045P1) on 16 Dec 2009. The patient experienced general weakness, sweating, burning and pain in the stomach and rib pain on the same day after vaccination. The events were not resolved. Outcome of the events was reported as condition unchanged.
Age: 5.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Underdose
Clinical narrative: Initial report received from a nurse on 02 Dec 2009: This patient was vaccinated with FLUVIRIN. The reporter stated that when the patient was receiving the dose, vaccine leaked down from the patient's arm. No further information available.
Age: 0.73
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Initial physician report received on 21 Dec 2009: This patient (9 month old child) was vaccinated with 0.25 mL dose S-OIV FLUVIRIN (batch no: unknown) on 15 Dec 2009. No adverse event was reported.
Age: 57.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Initial report received from health care professional on 16 Dec 2009: The caller stated that the patient received on 0.5 ml of Novartis H1N1 vaccine on 01 Dec 2009. On 09 Dec 2009, she had another 0.5 ml of Novartis H1N1 vaccine instead of FLUVIRIN. No adverse effect was reported. Following an internal review on 29 Jan 2010 of the data received on 16 Dec 2009 the following correction was made: The suspect drug was recoded to S-OIV FLUVIRIN.
Age: 2.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Initial report received from a health care professional on 16 Dec 2009: This patient was inadvertently vaccinated with FLUVIRIN (batch: 102135P1) 0.5 ml, intramuscular, on 15 Dec 2009 (off label use). The outcome of the event was not reported.
Age: 5.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: Initial report was received from a nurse on 23 Dec 2009: This patient had received a S-OIV FLUVIRIN intramuscular and a dose of intranasal H1N1 vaccine on 22 Dec 2009. No adverse events were reported.
Age: 3.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Initial report was received from a pharmacist on 21 Dec 2009: This patient (3 year old child) was vaccinated with H1N1 (batch no. 101326) on 15 Dec 2009. No adverse event was reported.
Age: 3.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Initial report was received from a pharmacist on 21 Dec 2009: This patient (3 year old child) was vaccinated with S-OIV FLUVIRIN (batch no. 101326) on 15 Dec 2009. No adverse event was reported.
Age: 2.0
Sex: M
Vaccine: FLU3
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Initial report received froM a healthcare professional on 28 Dec 2009: This patient,with an unknown medical history was vaccinated with 0.5 ml FLUVIRIN, intramuscularly on 28 Dec 2009. No further information was provided.
Age: 38.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: Initial report received from a health care professional on 22 Dec 2009: This patient was vaccinated with S-OIV FLUVIRIN (batch no. 1013274P) on 22 Dec 2009. The vaccine was administered via intranasal route instead of intravenous route. No adverse event was reported.
Age: 1.55
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Initial report received from a health care professional on 23 Dec 2009: This 18 months old child was vaccinated with S-OIV FLUVIRIN (batch no. 1013293P) on 22 Dec 2009. The vaccine was inadvertently given to the patient below age of 4 years. No adverse event was reported after vaccination.
Age: 52.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: No adverse event
Clinical narrative: Initial report received from a pharmacist on 22 Dec 2009: This patient, with an unknown medical history, was vaccinated with previously frozen FLUVIRIN (batch no. 102135P1), intramuscularly, on 21 Dec 2009. No adverse event was reported. No other information was provided.
Age: 56.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Initial report received from a pharmacist on 22 Dec 2009: This patient, with an unknown medical history, was vaccinated with previously frozen FLUVIRIN vaccine (batch no. 102135P1), intramuscularly, on 21 Dec 2009. No adverse event was reported. No other information was provided.
Age: 3.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Initial report received from health care professional on 23 Dec 2009: The reporter stated that a 3 year old child received FLUVIRIN on an unknown date. Outcome was not reported.
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Chills, Influenza like illness, Myalgia, Pyrexia
Clinical narrative: Initial report received from health care professional on 23 Dec 2009: This patient received FLUVIRIN on 17 Dec 2009. The patient experienced flu like symptoms, fever, chills and muscle pain with latency of 9/12 hours on the same day after FLUVIRIN was started. The outcome was reported as condition unchanged on an unknown date.
Age: 54.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Chills, Influenza like illness, Myalgia, Pyrexia
Clinical narrative: Initial report received from a HCP on 23 Dec 2009. The patient was vaccinated with S-OIV FLUVIRIN (batch no 960374P) 0.5 ml, intramuscular, on 17 Dec 2009. The patient experienced with flu-like symptoms, including fever, chills, and muscle pain on the same day, 17 Dec 2009. The outcome of the events were reported as condition unchanged.
Age: 72.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Acne, Headache, Nausea, Urticaria
Clinical narrative: Initial report received from a consumer on 24 Dec 2009: The patient was vaccinated with FLUVIRIN on 22 Dec 2009. On 23 Dec 2009, the patient began feeling nausea and headache which dissipated quickly. The patient also presented with two pimples on leg and a large hive on the right side of lower back. On an unspecified date, the patient received treatment with BENADRYL with no effect. The outcome of the events were reported as, ongoing. No other information was provided at the time of this report.
Age: 71.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Dyskinesia, Oral pain, Trismus
Clinical narrative: Initial report was received from a consumer (patient) on 22 Dec 2009: This patient received S-OIV FLUVIRIN on an unknown date. After a few hours of vaccination patient could not open her mouth or jaw. It was reported that after a couple of minutes patient was able to open her mouth little by little. Patient's mouth was hurt and she couldn't open her jaw without having a popping sound. The outcome of the event was not reported.
Age: 40.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Abdominal discomfort, Change of bowel habit, Dizziness, Dyspnoea, Insomnia
Clinical narrative: Initial consumer report received on 28 Dec 2009: This nursing patient was vaccinated with Influenza vaccine (batch no 1008133P) on 12 Nov 2009. One hour after receiving the vaccine, she experienced a tingling in her hands and feet and dizziness. She has also experienced bouts of difficulty breathing, difficulty sleeping, muscle weakness ("like her nervous system is not working right"), upset stomach, and a change in bowel habits. She has been to the emergency room twice regarding this. She states that her mother and her husband received the same vaccine lot without incident.
Age: 40.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Muscular weakness, Paraesthesia
Clinical narrative: Initial consumer report received on 28 Dec 2009: This nursing patient was vaccinated with Influenza vaccine (batch no 1008133P) on 12 Nov 2009. One hour after receiving the vaccine, she experienced a tingling in her hands and feet and dizziness. She has also experienced bouts of difficulty breathing, difficulty sleeping, muscle weakness ("like her nervous system is not working right"), upset stomach, and a change in bowel habits. She has been to the emergency room twice regarding this. She states that her mother and her husband received the same vaccine lot without incident.
Age: 70.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Muscular weakness, Pain, Pruritus, Skin ulcer
Clinical narrative: Initial consumer report received on 18 Dec 2009: This patient received FLUVIRIN 0.5 ml intramuscular dose in early Nov 2009. On the next day the patient had experienced an achy pain from head to toe in addition to generalized muscle weakness. The patient also had some sores on the hairline of his head and had an itching in his groin that also disappeared as the other symptoms appeared. The patient does not know if this was coincidental or not. The side effects were diminished but not completely subsided.
Age: 4.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Incorrect dose administered
Clinical narrative: Initial report from the healthcare professional on 31 Dec 2009: This patient was administered FLUVIRIN at a dose of 0.25 ml instead of 0.5 ml. The outcome of the event was not reported.
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Initial report received from physician on 29 Dec 2009: This patient was vaccinated with FLUVIRIN, intramuscular on unknown date. Approximately 2 weeks ago (approximately 15 Dec 2009), a 3.5 years old boy received one dose of the FLUVIRIN vaccine. The vaccine was injected into the deltoid. No adverse effect were noted after administration. The outcome of event was not reported.
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Initial report received from a nurse on 30 Dec 2009: This patient with an unknown medical history was vaccinated with Novarits H1N1 virus vaccine IM on an unknown date. The vaccine was inadvertently administered. No adverse event was reported.
Age: 3.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Case previously recorded as MA2009-4801. Initial case report received from a nurse, MedCom on 18 NOV 2009. A 3-year-old patient was vaccinated with 0.5 mL of S-OIV FLUVIRIN intramuscular (batch no. 10127601, 1013265P expiration date 31 MAR 2010) on 15 NOV 2009. No adverse events was reported. MedCom reference no. # NA09-008489.
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Case previously recorded as MA2009-4802. Initial case report received from a nurse via MeCom on 18 NOV 2009. A 3-years-old male patient was vaccinated with S-OIV FLUVIRIN (batch no. 10127601, 1013265P) 0.5mL i.m on 15 NOV 2009. No adverse effect was reported. MedCom reference no.: NA09-008489.
Age: 3.0
Sex: F
Vaccine: FLU3
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Case previously recorded as MA2009-4803. Initial case report received from a nurse via MedCom, on 18 NOV 2009. A 3-year-old female patient was vaccinated with 0.5 mL i.m. S-OIV FLUVIRIN (batch no. 102124P1; 1013265P) on 15 NOV 2009. It was an out of label use because the patient was younger than 4 years. No adverse events were noted upon administration. MedCom reference no.: NA09-008489.
Age: 1.02
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Case previously recorded as MA2009-4805. Initial case report received from a nurse on 18 NOV 2009. A 53-week-old female patient was vaccinated with S-OIV FOCETRIA (batch no. 102125P1) on 17 NOV 2009. The outcome was reported as not applicable.
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Unevaluable event
Clinical narrative: Case previously recorded as MA2009-4806. A girl was vaccinated with Novartis H1N1 vaccine. Reported vaccination date is 17NOV2008-this must be a mistake, because no H1N1 vaccine was licensed in this country in 2008.
Sex: U
Vaccine: FLU(H1N1)
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Case previously recorded as MA2009-5091. Received the following information via the Vaccine info call center from a healthcare professional on the 19 NOV 2009. This patient aged under 4-years-old, was vaccinated with S-OIV FLUVIRIN (batch number unknown) intramuscular on 18 NOV 2009. No adverse event was reported. Vaccine info call center reference no. NA09-008488.
Sex: U
Vaccine: FLU(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Case previously recorded as MA2009-5092. We received the following information via the vaccine info call center from a healthcare professional on the 19 NOV 2009. An unspecified number of patients under the age of 4-years-old, were vaccinated with S-OIV FLUVIRIN (batch number 102124P1) intramuscularly on an unspecified date. No adverse events were reported. Vaccine info call center reference no. NA09-008447.
Age: 2.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Case previously recorded as MA2009-5093. We received the following information via the Vaccine info call center from a healthcare professional on the 19 NOV 2009. This 2.5-year-old female patient was vaccinated inadvertently with S-OIV FLUVIRIN (batch number 10127605) intramuscular on 17 NOV 2009. No adverse reaction had occurred at the time of the report. Vaccine info call center reference no. NA09-008583.
Age: 1.01
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Case previously recorded as MA2009-5098. We received the following information via the Vaccine info call center, from a healthcare professional on the 19 NOV 2009. This 1-year-old female patient was vaccinated with 0.5ml S-OIV FLUVIRIN (batch number 102041P1) intramuscularly into the thigh on 17 NOV 2009. No adverse events were reported. Vaccine info call center reference no. NA09-008532.
Age: 1.85
Sex: M
Vaccine: FLU3
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Case previously recorded as MA2009-5154. Initial case report received from a physician, via Novartis Medical Communication on 20 NOV 2009. A 22-month-old male patient was vaccinated with S-OIV FOCETRIA (batch no. 102124P1, expiration date 31 MAR 2010) i.m. on 13 NOV 2009. No adverse event was reported. MedCom reference no.: NA09-008308.
Age: 1.85
Sex: M
Vaccine: FLU3
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Case previously recorded as MA2009-5156. Initial case report received from a physician via MedCom on 19 NOV 2009. A 1-year-old male patient was accidentally vaccinated with S-OIV FLUVIRIN (batch no. 102124P1) i.m. on 13 NOV 2009. No adverse effect was reported. MedCom reference no.: NA09-008308.
Age: 5.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Initial report received from a nurse on 10 Dec 2009: This patient received initial vaccination with FLUVIRIN (batch no 102136P1A) on 20 Nov 2009. The second dose was given on 03 Dec 2009 which was only fourteen days after the first dose. No adverse event was reported.
Age: 5.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Cough, Dyspnoea, Nasal congestion, Pyrexia
Clinical narrative: Initial report received from a consumer on 07 Dec 2009: This patient received FLUVIRIN on 05 Dec 2009. The patient was concomitantly administered with Nasal saline spray. The patient experienced nasal congestion, coughing, difficulty breathing and low grade fever (about 100 F) on 06 Dec 2009. The outcome of the event was reported as improving.
Age: 2.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Initial HCP report received on 04 Dec 2009: This patient under the age of four years was vaccinated with FLUVIRIN on 04 Dec 2009. No other adverse event was reported.
Age: 5.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: Initial report received from a registered nurse on 18 Dec 2009: This patient was vaccinated with S-OIV FLUVIRIN (batch no. 10073802) via intranasal route instead of intramuscular route. No adverse event was reported.
Age: 1.41
Sex: F
Vaccine: FLU3
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Case previously recorded as MA2009-5159. Initial case report received from a physician via MedCom on 19 NOV 2009. A patient 1-year-old female was vaccinated inadvertently with S-OIV FLUVIRIN (batch no. 102124P1) once i.m on 13 NOV 2009. No adverse event was reported. MedCom reference no.: NA09-008308.