chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.77
Sex: F
Vaccine: FLU3
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Case previously recorded as MA2009-5164. Initial case report received from a physician via MedCom, on 19 NOV 2009. A 1-year-old female 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: 1.85
Sex: M
Vaccine: FLU3
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Case previously recorded as MA2009-5157. Initial case report received from a physician via MedCom, on 19 NOV 2009. A patient 1-year-old male 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.
Age: 3.0
Sex: F
Vaccine: FLU3
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Case previously recorded as MA2009-4156. Initial case report received from a health professional via MedCom on 11 NOV 2009. A 3 year-old female patient was inadvertently vaccinated with 0.5 mL i.m S-OIV FLUVIRIN (batch no. 1008146P) on 11 NOV 2009. No adverse events were reported. MedCom reference no.: NA09-007993.
Age: 1.26
Sex: F
Vaccine: FLU3
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Case previously recorded as MA2009-4175. Initial case report received from a health care professional via MedCom on 12 NOV 2009. A 15 month-old female patient was vaccinated with S-OIV FLUVIRIN (batch no. 102045P1) i.m on 06 NOV 2009. MedCom reference no.:NA09-008060.
Age: 2.0
Sex: F
Vaccine: FLU3
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Case previously recorded as MA2009-4176. Initial case report received from a registered nurse via MedCom, on 12 NOV 2009. A 2-year-old female patient was accidentally vaccinated with S-OIV FLUVIRIN (batch no. 11041P1) i.m. on 11 NOV 2009. No adverse effect was reported. MedCom reference no.:NA09-008056.
Age: 1.3
Sex: U
Vaccine: FLU3
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Case previously recorded as MA2009-4181. Initial case report received from a practice administrator via Novartis Pharma, on 12 NOV 2009. A 15-month-old patient was vaccinated with S-OIV FLUVIRIN (batch no. unknown) i.m., on a not reporter date. No adverse events was reported. MedCom reference no.: NA09-008109.
Age: 3.0
Sex: F
Vaccine: FLU3
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Case previously recorded as MA2009-4182. Initial case report received from a physician via MedCom on 12 NOV 2009. A patient 3-year-old female was vaccinated with 0.5 mL S-OIV FLUVIRIN (batch no. 10073804) i.m on 11 NOV 2009. No adverse event was reported. MedCom reference no.: NA09-008134
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Case previously recorded as MA2009-4184. Initial case report received from a nurse, via Novartis Medical Communication on 12 NOV 2009. A 45 year-old patient was vaccinated with 0.5ml of S-OIV FLUVIRIN (batch no. 102044P1) i.m. on 10 NOV 2009. On 12 NOV 2009, the patient returned to receive a Hepatitis B vaccine, but she received a second 0.5 ml of S-OIV FLUVIRIN (batch no. 102044P1) i.m instead. No adverse event was reported. MedCom reference no.: NA09-008115.
Age: 1.54
Sex: M
Vaccine: FLU3
Symptoms: Inappropriate schedule of drug administration, No adverse event, Off label use
Clinical narrative: Case previously recorded as MA2009-4186. Initial case report received from non-health care professional, via Novartis Medical Communication on 12 NOV 2009. An 18 month-old patient was vaccinated with 0.5ml of S-OIV FLUVIRIN (batch no. 1402123P1) i.m. 12 NOV 2009. No adverse event was reported. MedCom reference no.: NA09-008108.
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Case previously recorded as MA2009-4187. Initial case report received from a physician via Novartis Pharma on 12 NOV 2009. A 3-year-old patient was vaccinated with 0.5 mL of S-OIV FLUVIRIN (batch no. 1402123P1) i.m. in left deltoid, on 12 NOV 2009. No adverse events was reported. MedCom reference no.: NA09-008108.
Sex: U
Vaccine: FLU3
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Case previously recorded as MA2009-4188. Initial case report received from a health care professional via MedCom, on 12 NOV 2009. A patient of unknown demography was vaccinated with S-OIV FLUVIRIN (batch no. 100814) i.m. on an unknown date. Vaccine was stored at 34F. No adverse event was reported. MedCom reference no.: NA09-008065.
Age: 1.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Case previously recorded as MA2009-4189. Initial report received from a physician on 12 Nov 2009: A one year infant was inadvertently administered a dose of S-OIV FLUVIRIN (batch no 102045P1) on 10 NOV 2009. No adverse reaction occurred. Reference No: MA2009-4189.
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Case previously recorded as MA2009-4199. Initial case report received from a health case professional via MedCom on 10 NOV 2009. A 3 year-old male patient was vaccinated with 0.5 mL once of S-OIV FLUVIRIN (batch no. 100813) i.m on 04 NOV 2009. No adverse events were reported. MedCom reference no.: NA09-007859.
Age: 2.0
Sex: F
Vaccine: FLU3
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 inadvertently administered FLUVIRIN, intramuscularly into the thigh on an unspecified date. No adverse event was reported. No further information was provided.
Age: 61.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Arthralgia, Chest discomfort, Cough, Hyperhidrosis, Myalgia
Clinical narrative: Initial report received from a physician on 29 Dec 2009: This patient with an unknown medical history was vaccinated with Novartis H1N1 IM on 21 Dec 2009. On 27 Dec 2009, the patient experienced coughing, chest discomfort, diaphoresis, arthralgia, and myalgia in his lower extremities. These symptoms were dissipated (improved).
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Chest discomfort, Cough, Flushing, Hyperhidrosis
Clinical narrative: Initial report received from a physician on 29 Dec 2009: The patient received S-OIV FLUVIRIN, 0.5 ml, intramuscularly on 21 Dec 2009. The patient was concomitantly administered with LEVAQUIN as a prophylaxis for infection. The patient experienced flushing on 22 Dec 2009. The patient also experienced coughing, chest discomfort, diaphoresis, arthralgia, myalgia in her lower extremities/bilateral myalgia in his calves on 25 Dec 2009. It was reported that, the symptoms dissipated and returned to work on 28 Dec 2009. The patient visited his physician and found that his lungs were clear and had nasal congestion on 29 Dec 2009. The patient was then treated with post nasal drip. The patient was advised to continued LEVAQUIN for another three more days (dates unspecified). The outcome the event was reported as condition unchanged.
Sex: M
Vaccine: FLU3
Symptoms: Myalgia, Nasal congestion
Clinical narrative: Initial report received from a physician on 29 Dec 2009: The patient received S-OIV FLUVIRIN, 0.5 ml, intramuscularly on 21 Dec 2009. The patient was concomitantly administered with LEVAQUIN as a prophylaxis for infection. The patient experienced flushing on 22 Dec 2009. The patient also experienced coughing, chest discomfort, diaphoresis, arthralgia, myalgia in her lower extremities/bilateral myalgia in his calves on 25 Dec 2009. It was reported that, the symptoms dissipated and returned to work on 28 Dec 2009. The patient visited his physician and found that his lungs were clear and had nasal congestion on 29 Dec 2009. The patient was then treated with post nasal drip. The patient was advised to continued LEVAQUIN for another three more days (dates unspecified). The outcome the event was reported as condition unchanged.
Age: 62.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Arthralgia, Chest discomfort, Cough, Hyperhidrosis, Myalgia
Clinical narrative: Initial report received from a physician on 29 Dec 2009. The patient took LEVAQUIN concomitantly. This patient was vaccinated with FLUVIRIN (batch no: 102138P1A) on 21 Dec 2009. The patient experienced with coughing, chest discomfort, diaphoresis, arthralgia, myalgia in lower extremities and bilateral myalgia in calves on 24 Dec 2009. These symptoms dissipated and the patient returned to work on 28 Dec 2009. The patient was examined by physician and it was found that the lungs were clear but the patient had nasal congestion from an unknown date. The patient had treatment with postnasal drip. The outcome of the events were reported as condition unchanged.
Age: 62.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Nasal congestion, Upper-airway cough syndrome
Clinical narrative: Initial report received from a physician on 29 Dec 2009. The patient took LEVAQUIN concomitantly. This patient was vaccinated with FLUVIRIN (batch no: 102138P1A) on 21 Dec 2009. The patient experienced with coughing, chest discomfort, diaphoresis, arthralgia, myalgia in lower extremities and bilateral myalgia in calves on 24 Dec 2009. These symptoms dissipated and the patient returned to work on 28 Dec 2009. The patient was examined by physician and it was found that the lungs were clear but the patient had nasal congestion from an unknown date. The patient had treatment with postnasal drip. The outcome of the events were reported as condition unchanged.
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Initial nurse report received on 30 Dec 2009: This patient younger than 4 month was vaccinated by FLUVIRIN (batch 102141P1) 0.25 ml intramuscular into the thigh on an unknown date. The patient did not experience any other adverse effect.
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Case previously recorded as MA2009-4200. Initial case report received from a medical assistant via MedCom on 11 NOV 2009. A 3-year-old male patient was accidentally vaccinated with S-OIV FLUVIRIN (batch no. 102046P1) i.m. on 05 NOV 2009. No adverse effect was reported. MedCom reference no.: NA09-007859.
Age: 3.0
Sex: F
Vaccine: FLU3
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Case previously recorded as MA2009-4201. Initial case report received from a health care professional, via Novartis Medical Communication on 10 NOV 2009. A 3 year-old male patient was vaccinated with 0.5ml of S-OIV FLUVIRIN (batch no. 102046P1) i.m. on 05 NOV 2009. No adverse event was reported. MedCom reference no.: NA09-007859.
Age: 3.0
Sex: F
Vaccine: FLU3
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Case previously recorded as MA2009-4202. Initial case report received from a physician via Novartis Pharma on 10 NOV 2009. A 3-year-old female patient was vaccinated with 0.5 mL of S-OIV FLUVIRIN (batch no. 102046P1) i.m., on 05 NOV 2009. MedCom reference no.: NA09-007859.
Age: 3.0
Sex: F
Vaccine: FLU3
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Case previously recorded as MA2009-4203. Initial case report received from a medical assistant via MedCom on 10 NOV 2009. A patient 3-year-old female was vaccinated with 0.5mL S-OIV FLUVIRIN (batch no. 102046P1) once i.m on 05 NOV 2009. No adverse event was reported. MedCom reference no.: NA09-007859.
Sex: U
Vaccine: FLU3
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Case previously recorded as MA2009-4213. Initial case report received from a registered nurse via MedCom on 11 NOV 2009. It was reported that 13 children under the age of four were accidentally vaccinated with 0.25 mL of S-OIV FLUVIRIN (batch no. 102046P1) i.m. on 10 NOV 2009. No adverse effect was reported. MedCom reference no.: NA09-008010.
Sex: U
Vaccine: FLU3
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Case previously recorded as MA2009-4214. Initial case report received from a nurse, via Novartis Medical Communication on 11 NOV 2009. A patient under 4 year-old was vaccinated with 0.25 ml of S-OIV FLUVIRIN (batch no. 102046P1) i.m., on 10 NOV 2009. No adverse event was reported. MedCom reference no.: NA09-008010.
Sex: U
Vaccine: FLU3
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Case previously recorded as MA2009-4215. Initial case report received from a Nurse via MedCom on 11 NOV 2009. Patient below 4-year-old was vaccinated with 0.25 mL of S-OIV FLUVIRIN (batch no. 102046P1) i.m. on 10 NOV 2009. MedCom reference no.: NA09-008010.
Sex: U
Vaccine: FLU3
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Case previously recorded as MA2009-4216. Initial case report received from a physician via MedCom on 11 NOV 2009. A patient, under the age of 4, was vaccinated with 0.25mL S-OIV FLUVIRIN (batch no. 102046P1) i.m on 10 NOV 2009. No adverse event was reported. MedCom reference no.: NA09-008010.
Sex: U
Vaccine: FLU3
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Case previously recorded as MA2009-4217. Initial case report received from a nurse via MedCom on 11 NOV 2009. A patient under 4 year-old was vaccinated with 0.25 mL of S-OIV FLUVIRIN (batch no. 102046P1) i.m on 10 NOV 2009. No adverse events were reported. MedCom reference no.: NA09-008010.
Sex: U
Vaccine: FLU3
Symptoms: No adverse event
Clinical narrative: Case previously recorded as MA2009-4218. Initial case report received from a registered nurse via agency, on 11 NOV 2009. It was reported that 13 children under the age of four were accidentally vaccinated with 0.25 mL of S-OIV FLUVIRIN (batch no. 102046P1) i.m. on 10 Nov 2009. No adverse effect was reported. Agency reference no.:NA09-008010.
Sex: U
Vaccine: FLU3
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Case previously recorded as MA2009-4219. Initial case report received from a nurse, via Novartis Medical Communication on 11 NOV 2009. A patient under 4 year-old was vaccinated with 0.25 ml of S-OIV FLUVIRIN (batch no. 102046P1) i.m. on 10 NOV 2009. No adverse event was reported. MedCom reference no.: NA09-008010.
Sex: U
Vaccine: FLU3
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Case previously recorded as MA2009-4220. Initial case report received from a Nurse via MedComon 11 NOV 2009. Patient below 4-year-old was vaccinated with 0.25 mL of S-OIV FLUVIRIN (batch no. 102046P1) i.m. on 10 NOV 2009. MedCom reference no.: NA09-008010.
Sex: U
Vaccine: FLU3
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Case previously recorded as MA2009-4221. Initial case report received from a physician via agency, on 11 NOV 2009. A patient, under the age of 4, was vaccinated with 0.25mL S-OIV FLUVIRIN (batch no. 102046P1) i.m. on 10 NOV 2009. No adverse event was reported. Agency reference no.: NA09-008010.
Sex: U
Vaccine: FLU3
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Case previously recorded as MA2009-4222. Initial case report received from a nurse via agency, on 11 NOV 2009. A patient under 4 year-old was vaccinated with 0.25 mL of S-OIV FLUVIRIN (batch no. 102046P1) i.m on 10 NOV 2009. No adverse events were reported. Agency reference no.: NA09-008010.
Sex: U
Vaccine: FLU3
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Case previously recorded as MA2009-4223. Initial case report received from a registered nurse via agency, on 11 NOV 2009. It was reported that 13 children under the age of four were accidentally vaccinated with 0.25 mL of S-OIV FLUVIRIN (batch no. 102046P1) i.m. on 10 NOV 2009. No adverse effect was reported. Agency reference no.: NA09-008010.
Age: 71.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Pruritus
Clinical narrative: Initial report received from a consumer on 17 Dec 2009: This patient with an unknown medical history was vaccinated with H1N1 (manufacturer unknown, batch: 10127602) on 15 Dec 2009. The patient experienced itchiness on her arms and trunk. The events were resolved on 16 Dec 2009.
Age: 46.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Auricular swelling, Erythema, Local swelling, Pruritus, Swelling face
Clinical narrative: Initial report received from other health care profession on 04 Dec 2009. The patient was vaccinated with FLUVIRIN on an unknown date. The patient experienced with face, ears and neck were swollen, accompanied by the presence of redness and itchiness in the swollen areas on 04 Dec 2009. The events was not recovered. Following internal review on 05 Feb 2010, the following correction was made: The case was re-assessed as unlisted.
Age: 3.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Initial report received from a health care professional on 09 Dec 2009: This patient (37 months) inadvertently received FLUVIRIN 0.5 ml on 07 Dec 2009. No adverse events were noted upon administration. The outcome of the event was not reported. Following an internal review done on 11 Feb 2010 of the data received on 09 Dec 2009 following changes was made: The event coding was changed to off label use.
Age: 2.0
Sex: U
Vaccine: FLU(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Initial report received from the physician on 09 Dec 2009: This patient was inadvertently administered a 0.5 ml IM dose of S-OIV FLUVIRIN on 09 Dec 2009. No adverse events were noted upon administration.
Age: 17.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Abdominal pain, Diarrhoea, Nausea
Clinical narrative: Initial report received from the consumer (patient's father) on 09 Dec 2009: The patient received S-OIV FLUVIRIN 0.5 ml intramuscular vaccination on 05 Dec 2009. On 07 Dec 2009, the patient experienced nausea, diarrhea and abdominal pain. The outcome of diarrhea was reported to be subsided and the outcome of nausea and abdominal pain was reported to be ongoing.
Age: 3.0
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 09 Dec 2009: This patient inadvertently received S-OIV FLUVIRIN 0.5 ml intramuscular, on 05 Dec 2009. No adverse events were reported upon administration. Following an internal review on 11 Feb 2010 of the data received on 09 Dec 2009 following changes was made: The event off label use was coded.
Age: 0.61
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Initial report received from a health care professional on 09 Dec 2009: This patient, with an unknown medical history, was inadvertently administered FLUVIRIN 0.5 ml intramuscularly on 27 Nov 2009. The outcome of the event was not reported.
Age: 3.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Initial report received from a physician on 09 Dec 2009: This patient was vaccinated inadvertently with FLUVIRIN on 09 Dec 2009. The patient did not experience any events. No further information was provided. Following an internal review done on 11 Feb 2010 of the data received on 09 Dec 2009 following correction was made: The event off label use was coded.
Age: 6.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Initial report received from a physician on 09 Dec 2009: This report is a medication error. The patient received H1N1 nasal spray on 09 Dec 2009 (MedImmune). A couple of hours later, 0.5 mL, intramuscular dose of FLUVIRIN was administered to the patient. No adverse effects were noted upon administration.
Age: 1.41
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Initial report received from a health care professional via health authority (NA09-009488) on 10 Dec 2009: This patient, 16 month old, received FLUVIRIN (batch no: 102044P1), 0.25 ml, intramuscular, into the thigh, on 09 Nov 2009. No adverse effects 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 consumer on 11 Dec 2009: This patient (3 year old) inadvertently received FLUVIRIN 0.5 ml, intramuscular on 10 Dec 2009. No adverse events were reported upon administration.
Age: 4.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: Initial report received from a HCP on 14 Dec 2009. This patient inadvertently received a 0.5 mL IM dose of FLUVIRIN intranasally instead of intramuscularly on 14 Dec 2009. No adverse effects were noted upon administration.
Age: 1.3
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Initial HCP report received on 08 Dec 2009: This patient (16 months old) was vaccinated with FLUVIRIN (batch unknown) on 08 Dec 2009. No other adverse event was reported. Following an internal review done on 11 Feb 2010 of the data received on 09 Dec 2009 following correction was made: The event off label use was coded.
Age: 0.73
Sex: F
Vaccine: FLU3
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Case previously recorded as MA2009-4283. Initial case report received from a physician via agency, on 04 NOV 2009. A patient 9-month-old female was vaccinated with 0.5mL S-OIV FLUVIRIN (batch no. 100813) once i.m. on 02 NOV 2009. No adverse event was reported. Agency reference no.: NA09-007607.
Age: 1.62
Sex: M
Vaccine: FLU3
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Case previously recorded as MA2009-4284. Initial case report received from a physician via agency, on 04 NOV 2009. A 19 month-old male patient was vaccinated with 0.5 mL of S-OIV FLUVIRIN (batch no. 100813) i.m. on 04 NOV 2009. No adverse events were reported. Agency reference no.: NA09-007607.
Age: 1.04
Sex: M
Vaccine: FLU3
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Case previously recorded as MA2009-4285. Initial case report received from a pediatrician via agency on 04 NOV 2009. A 1-year-old male patient was accidentally vaccinated with FLUVIRIN (batch no. 100813) i.m. on 30 OCT 2009. No adverse effect was reported. Company assessment: Seriousness criterion: not serious. Causality: not applicable. Expectedness assessment according to label: Off label use (child under 4 years old) is unexpected regarding vaccination with FLUVIRIN. No change in benefit-risk-ratio. No measures necessary. Reference no: NA09-007607.
Age: 0.85
Sex: M
Vaccine: FLU3
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Case previously recorded as MA2009-4286. Initial case report received from a pediatrician via Novartis, on 04 NOV 2009. An 11 month-old male patient was vaccinated with 0.5 ml of FLUVIRIN 2009/2010 (batch no. 100813, expiration date 01 FEB 2010) i.m. on 04 NOV 2009, an off-label indication. No adverse event was reported. Reference no: NA09-007607
Age: 0.7
Sex: M
Vaccine: FLU3
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Case previously recorded as MA2009-4287. Initial case report received from a pediatrician via agency, on 05 NOV 2009. A 9-month-old patient was vaccinated with 0.5 mL of S-OIV FLUVIRIN (batch no. 100813) i.m., on 02 NOV 2009. No adverse events was reported. Agency reference no.: NA09-007607.
Age: 0.8
Sex: F
Vaccine: FLU3
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Case previously recorded as MA2009-4289. Initial case report received from a physician on 04 NOV 2009. A 9 month-old female patient was vaccinated with 0.5 mL of FLUVIRIN 2009/2010 (batch no. 100813) i.m. on 04 NOV 2009. No adverse events were reported. Reference no: NA09-007607.
Age: 0.55
Sex: F
Vaccine: FLU3
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Case previously recorded as MA2009-4290. Initial case report received from a registered nurse via agency, on 04 NOV 2009. A 6 month-old female patient was accidentally vaccinated with S-OIV FLUVIRIN (batch no. 100813) i.m. on 04 NOV 2009. No adverse effect was reported. Agency reference no.:NA09-007607.
Age: 0.78
Sex: M
Vaccine: FLU3
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Case previously recorded as MA2009-4291. Initial case report received from a pediatrician on 04 NOV 2009. A 9 month-old male patient was vaccinated with 0.5 ml FLUVIRIN 2009/2010 (batch no. 100813, expiration date 01 FEB 2010) i.m. on 30 OCT 2009, an off-label indication. No adverse event was reported. NA09-007607.
Age: 3.0
Sex: F
Vaccine: FLU3
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Case previously recorded as MA2009-4292. Initial case report received from a pediatrician via MedCom, on 05 NOV 2009. A 3-year-old female patient was vaccinated with 0.5 mL of S-OIV FLUVIRIN (batch no. 100813) i.m., on 03 NOV 2009. No adverse events was reported. MedCom reference no.: NA09-007607.
Age: 2.0
Sex: M
Vaccine: FLU3
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Case previously recorded as MA2009-4295. Initial case report received from a registered nurse via agency, on 13 NOV 2009. A 2.5 year-old male patient was accidentally vaccinated with S-OIV FLUVIRIN (batch no. 1013266P) i.m. on 10 NOV 2009. No adverse effect was reported. Agency reference no.:NA09-008180.
Age: 2.0
Sex: U
Vaccine: FLU3
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Case previously recorded as MA2009-4298. Initial case report received from a nurse, via Novartis Medical Communication, on 13 NOV 2009. A 2 year-old patient was vaccinated with 0.5ml of S-OIV FLUVIRIN (batch no. unknown) i.m. on 13 NOV 2009, an off-label indication. No adverse event was reported. Agency reference no.: NA09-008210.
Sex: U
Vaccine: FLU3
Symptoms: Dizziness, Injection site pain, Local reaction
Clinical narrative: Case previously recorded as MA2009-4308. Received the following information via Novartis Vaccines and Diagnostics, on 10 NOV 2009:  Multiple patients were vaccinated with influenza vaccine (manufacturer and batch no. unknown) on unknown dates. They experienced dizziness and injection site reaction with pain and local reaction on unknown dates. The outcome of the symptoms was unknown at reporting date. We received the following additional information via Novartis Vaccines and Diagnostics, on 16 NOV 2009: FLUVIRIN (unclear if H1N1 (pandemic or seasonal) was vaccinated.
Age: 0.51
Sex: F
Vaccine: FLU3
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Case previously recorded as MA2009-4316. Initial case report received from physician via agency, on 16 NOV 2009. A 6 month-old male patient was accidentally vaccinated with S-OIV FLUVIRIN (batch no. 1009231P) i.m. on 16 NOV 2009. No adverse effect was reported. Agency reference no.:NA09-008284.
Age: 2.0
Sex: M
Vaccine: FLU3
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Case previously recorded as MA2009-4318. Initial case report received from a health case professional via agency, on 11 NOV 2009. A 2 year-old male patient was vaccinated with 0.5 mL once of S-OIV FLUVIRIN (batch no. 102125P1) i.m. on 11 NOV 2009. No adverse events were reported. Agency reference no.: NA09-007978.
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Case previously recorded as MA2009-4319. Initial case report received from a medical assistant via agency, on 11 NOV 2009. A 3-year-old male patient was accidentally vaccinated with FLUVIRIN (batch no. 102125P1) i.m. on 11 NOV 2009. No adverse effect was reported. Agency reference no.: NA09-007978.
Age: 2.0
Sex: M
Vaccine: FLU3
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Case previously recorded as MA2009-4320. Initial case report received from a health case professional via agency, on 11 NOV 2009. A male patient was vaccinated with 0.5 mL once of S-OIV FLUVIRIN (batch no. 102125P1) i.m. on 11 NOV 2009. No adverse events were reported. Agency reference no.: NA09-007978.
Age: 1.23
Sex: M
Vaccine: FLU3
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Case previously recorded as MA2009-4321. Initial case report received from a health case professionall via agency, on 11 NOV 2009. A male patient was vaccinated with 0.5 mL once of FLUVIRIN (batch no. 102125P1) i.m on 11 NOV 2009. No adverse events were reported. Agency reference no.: NA09-007978.
Age: 1.48
Sex: M
Vaccine: FLU3
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Case previously recorded as MA2009-4322. Initial case report received from a health case professional via agency, on 11 NOV 2009. A male patient born on 18 May 2007 was vaccinated with 0.5 mL once of FLUVIRIN (batch no. 102125P1) i.m on 11 NOV 2009. No adverse events were reported. Agency reference no: NA09-007978.
Age: 3.0
Sex: F
Vaccine: FLU3
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Case previously recorded as MA2009-4323. Initial case report received from a health case professional via agency, on 11 NOV 2009. A female patient was vaccinated with 0.5 mL once of FLUVIRIN (batch no. 102125P1) i.m on 11 NOV 2009. No adverse events were reported. Agency reference no: NA09-007978.
Age: 8.0
Sex: M
Vaccine: FLU3
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Case previously recorded as MA2009-4324. Initial case report received from a health care professional via agency, on 16 NOV 2009. An 18 year-old male patient was vaccinated with 0.5 mL of FLUVIRIN (batch no. 102040P1) i.m on 16 NOV 2009. After vaccination, it was noticed that the patient already received FLUVIRIN in a nasal form in a couple of weeks ago. No adverse event were reported. Agency reference no.: NA09-008278.
Age: 18.0
Sex: F
Vaccine: FLU3
Symptoms: Device leakage, Drug exposure during pregnancy, Incorrect dose administered, No adverse event
Clinical narrative: Case previously recorded as MA2009-4327. Initial case report received from a physician via agency, on 16 NOV 2009. An 18-year-old female pregnant patient was vaccinated with 0.5 mL of FLUVIRIN (batch no. unknown) i.m. on 16 NOV 2009. Upon injection, some of the vaccine leaked from the area of needle attachment onto the patient's arm. As a consequence, patient did not receive full dose. No adverse effect was reported. Agency reference no.: NA09-008243. Follow up report received on 26 Apr 2010: There was an attempt to contact reporter, but no response received so far. Therefore the case was closed with a consideration as a lost to follow up.
Age: 31.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Dysgeusia
Clinical narrative: Case previously recorded as MA2009-4337. Initial case report received from a consumer via agency on 17 NOV 2009. An adult female patient was vaccinated i.m. for the first time with S-OIV FLUVIRIN on 17 NOV 2009. She experienced metallic taste following administration of FLUVIRIN. The patient was receiving immunosuppressant therapy after receiving a kidney transplant at unknown time. Medical history: Kidney transplant and metallic taste after transplantation. Agency reference no.: NA09-008414.
Age: 2.0
Sex: M
Vaccine: FLU3
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Case previously recorded as MA2009-4323. Initial case report received from a health case professional via agency, on 11 NOV 2009. A male patient born on 22 July 2007 was vaccinated with 0.5 mL once of FLUVIRIN (batch no. 102125P1) i.m. on 11 NOV 2009. No adverse events were reported. Company assessment: Seriousness criterion: not serious. Causality: not applicable. Expectedness assessment according to foreign and local label: Administration to a child younger than 4 years is unexpected after vaccination with FLUVIRIN. No change in benefit-risk-ratio. No measures are necessary. Agency reference no.: NA09-007978.
Age: 2.0
Sex: F
Vaccine: FLU3
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Case previously recorded as MA2009-4341. Initial case report received from a consumer via agency, on 16 NOV 2009. A 2-year-old patient was vaccinated with 0.25 mL i.m. S-OIV FLUVIRIN (batch no. 102124P1) on 12 NOV 2009. It was an off label use because the patient was younger than 4 years. No adverse event was reported. Agency reference no.: NA09-008244.
Sex: U
Vaccine: FLU3
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Case previously recorded as MA2009-4342. Initial case report received from a health care professional via agency, on 17 NOV 2009. An infant patient was vaccinated with 0.25 mL of S-OIV FLUVIRIN (batch no. unknown) i.m. on 16 NOV 2009. No adverse events were reported. Agency reference no.: NA09-008279.
Age: 2.0
Sex: F
Vaccine: FLU3
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Case previously recorded as MA2009-4370. Initial case report received from a physician via Novartis Pharma, on 12 NOV 2009. A 2-year-old patient was vaccinated with 0.5 mL of S-OIV FLUVIRIN (batch no. 102041P) i.m., on 09 NOV 2009. No adverse events was reported. Agency reference no.: NA09-008119.
Age: 0.51
Sex: F
Vaccine: FLU3
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Case previously recorded as MA2009-4372. Initial case report received from a medical assistant via agency, on 12 NOV 2009. A patient 6-month-old female was vaccinated with 0.5 S-OIV FLUVIRIN (batch no. 102041P) once i.m. on 09 NOV 2009. No adverse event was reported. Agency reference no.: NA09-008119.
Age: 1.61
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Case previously recorded as MA2009-4373. Initial case report received from a health care professional via agency, on 16 NOV 2009. A 19 month-old male patient was vaccinated with 0.5 mL of S-OIV FLUVIRIN (batch no. 102045P1) i.m. on 10 NOV 2009. No adverse events were reported. Agency reference no.: NA09-008119.
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Case previously recorded as MA2009-4374. Initial case report received from a medical assistant via agency, on 12 NOV 2009. A 3 year-old male patient was accidentally vaccinated with FLUVIRIN (batch no. 102041P) i.m. on 10 NOV 2009. No adverse effect was reported. Company assessment: Seriousness criterion: not serious. Causality: not applicable. Expectedness assessment according to foreign and local label: Off label use (child under 4 years old) is unexpected regarding vaccination with FLUVIRIN. No change in benefit-risk-ratio. No measures necessary. Agency reference no.: NA09-008119.
Age: 2.0
Sex: F
Vaccine: FLU3
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Case previously recorded as MA2009-4375. Initial case report received from a health care professional, via Novartis Medical Communication on 12 NOV 2009. A 2 year-old female patient was vaccinated with 0.5 ml of FLUVIRIN (batch no. 102041P, expiration date 31 MAR 2010) i.m. on 11 NOV 2009, an off-label indication. No adverse event was reported. Agency reference no.: NA09-008119.
Sex: U
Vaccine: FLU3
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Case previously recorded as MA2009-4224. Initial case report received from a nurse, via Novartis Medical Communication on 11 NOV 2009. The patient under 4 year-old was vaccinated with 0.25 ml of FLUVIRIN (batch no. 102046P1) i.m. on 10 NOV 2009, an off-label indication. No adverse event was reported. Company assessment: Seriousness criterion: not serious. Causality: not applicable. Expectedness assessment according to foreign and local label: Vaccination in children younger than 4 year-old is an off-label use and unexpected for FLUVIRIN. No change in benefit-risk-ratio. No measures necessary. Agency reference no.: NA09-008010.
Sex: U
Vaccine: FLU3
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Case previously recorded as MA2009-4225. Initial case report received from a Nurse via agency, on 11 NOV 2009. Patient below 4-year-old was vaccinated with 0.25 mL of FLUVIRIN (batch no. 102046P1) i.m. on 10 NOV 2009. Company assessment: Seriousness criterion: not serious. Causality: Not applicable. Expectedness assessment according to foreign and local label. Off label use is unexpected with FLUVIRIN. No change in benefit-risk-ratio. No measures necessary. Reference no.: NA09-008010.
Age: 2.0
Sex: M
Vaccine: FLU3
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Administration to a child under 4 year-old (Off label use).
Age: 0.52
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Administration to a child younger than 4 years.
Age: 3.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Case previously recorded as MA2009-4236. Initial case report received from a registered nurse via agency, on 11 NOV 2009. A 3-year-old female patient was accidentally vaccinated with FLUVIRIN 2009/2010 (batch no. 11041P1) i.m. on 11 NOV 2009. No adverse effect was reported. Company assessment: Seriousness criterion: not serious. Causality: not applicable. Expectedness assessment according to foreign and local label: Off label use (child under 4 years old) is unexpected regarding vaccination with FLUVIRIN 2009/2010. No change in benefit-risk-ratio. No measures necessary. Reference no.: NA09-007964.
Age: 3.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Case previously recorded as MA2009-4237. Initial case report received from a nurse, via agency, on 11 NOV 2009. A 3-year-old female patient was vaccinated with 0.5 ml with FLUVIRIN 2009/2010 (batch no. 101041P1, expiration date 30 MAR 2010) i.m. on 11 NOV 2009, an off-label indication. No adverse event was reported. Company assessment: Seriousness criterion: not serious. Causality: not applicable. Expectedness assessment according to foreign and local label: Vaccination in children younger than 4 year-old is an off-label and unexpected for FLUVIRIN (2009/2010). No change in benefit-risk-ratio. No measures necessary. Agency reference no.: NA09-007964.
Age: 1.63
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Case previously recorded as MA2009-4265. Initial case report received from a nurse via agency on 13 NOV 2009. A 19 month-old female patient was vaccinated with FLUVIRIN (batch no. 102125P1) i.m on 13 NOV 2009. No adverse events were reported. Company assessment: Seriousness criterion: not serious. Causality: not applicable. Expectedness assessment according to foreign and local label: Administration to a child younger than 4 years is unexpected after vaccination with FLURIVIN 2009/2010. No change in benefit-risk-ratio. No measures are necessary. Agency reference.:NA09-008218.
Age: 1.54
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Case previously recorded as MA2009-4266. Initial case report received from a health care professional via agency on 13 NOV 2009. A 18-month-old male patient was accidentally vaccinated with FLUVIRIN 2009/2010 (batch no. 1013266P) i.m. on 13 NOV 2009. No adverse effect was reported. Company assessment: Seriousness criterion: not serious. Cauasality: not applicable. Expectedness assessment according to foreign and local label: Off label use (child under 4 years old) is unexpected regarding vaccination with FLUVIRIN 2009/2010. No change in benefit-risk-ratio. No measures necessary. Agency reference no.: NA09-008215.
Age: 1.69
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Case previously recorded as MA2009-4274. Initial case report received from a non health care professional on 13 NOV 2009, A 5 year-old female patient was inadvertently vaccinated with 0.5 mL of FLUVIRIN (batch no. 101326P) i.m on 13 NOV 2009. No adverse events were reported. Reference no: NA09-008207. Follow-up information received on 25 NOV 2009: The patient was 20-months (date of birth: 06MAR 2008) of age, not 5 years initially reported.
Age: 1.26
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Case previously recorded as MA2009-4279. Initial case report received from a health care professional on 13 NOV 2009. A 15 month-old female patient was vaccinated with FLUVIRIN 2009/2010 (batch no. 1008141P) i.m. on 13 NOV 2009, an off-label indication. No adverse event was reported. Reference no: NA09-008196
Age: 3.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Case previously recorded as MA2009-4280. Initial case report received from a pediatrician on 04 NOV 2009. A 8 year-old male patient was vaccinated with 0.5 ml FLUVIRIN 2009/2010 (batch no 100813, expiration date 01 FEB 2010) i.m. on 02 NOV 2009, an off-label indication. No adverse event was reported. NA09-007607
Age: 3.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Case previously recorded as MA2009-4281. Initial case report received from a pediatrician on 05 NOV 2009. A 3-year- old male patient was vaccinated with 0.5 mL FLUVIRIN 2009/2010 (batch no. 100813) i.m., on 04 NOV 2009. No adverse events was reported. Reference no: NA09-007607.
Age: 1.61
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Case previously recorded as MA2009-4282. Initial case report received from a physician on 04 NOV 2009. A patient 1-year-old female was vaccinated with 0.5mL FLUVIRIN 2009/2010 (batch no. 100813) once i.m on 03 NOV 2009. Reference no: NA09-007607.
Age: 3.0
Sex: U
Vaccine: FLU(H1N1)
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Case previously recorded as MA2009-4580. Initial case report received from a physician on 17 NOV 2009. A 3-year-old or younger patient was vaccinated with FLUVIRIN 2009/2010 (batch no. unknown) i.m on 13 NOV 2009. Reference no: NA09008308.
Age: 3.0
Sex: U
Vaccine: FLU(H1N1)
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Initial case report received from a physician on 17 NOV 2009. A 3-year-old or younger patient was vaccinated with FLUVIRIN 2009/2010 (batch no. unknown) i.m. on 13 NOV 2009. Reference no: NA09-008308.
Age: 3.0
Sex: U
Vaccine: FLU(H1N1)
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Case previously recorded as MA2009-4582. Initial case report received from a physician on 17 NOV 2009. A 3-year-old or younger patient was vaccinated with FLUVIRIN 2009/2010 (batch no. unknown) i.m. on 13 NOV 2009. Reference no: NA09-008308.
Age: 3.0
Sex: U
Vaccine: FLU(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Case previously recorded as MA2009-4583. Initial case report received from a physician on 17 NOV 2009. A 3-year-old or younger patient was vaccinated with FLUVIRIN 2009/2010 i.m. on 13 NOV 2009. No adverse events was reported. Reference no: NA09-008308.
Age: 3.0
Sex: U
Vaccine: FLU(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Case previously recorded as MA2009-4584. Initial case report received from a physician on 17 NOV 2009. A 3-year-old or younger patient was vaccinated with FLUVIRIN 2009/2010 i.m. on 13 NOV 2009. No adverse events was reported. Reference no: NA09-008308.
Age: 3.0
Sex: U
Vaccine: FLU(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Case previously recorded as MA2009-4585. Initial case report received from a physician on 17 NOV 2009. A 3-year-old or younger patient was vaccinated with FLUVIRIN 2009/2010 i.m. on 13 NOV 2009. No adverse events was reported. Reference no: NA09-008308.
Age: 3.0
Sex: U
Vaccine: FLU(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Case previously recorded as MA2009-4586. Initial case report received from a physician on 17 NOV 2009. A patient 3-year-old or younger was vaccinated with FLUVIRIN 2009/2010 i.m. on 13 NOV 2009. No adverse effect was reported. Reference no: NA09-008308.
Age: 3.0
Sex: U
Vaccine: FLU(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Case previously recorded as MA2009-4587. Initial case report received from a physician on 17 NOV 2009. A patient 3-year-old or younger was vaccinated with FLUVIRIN 2009/2010 i.m on 13 NOV 2009. No adverse effect was reported. Reference no: NA09-008308
Age: 3.0
Sex: U
Vaccine: FLU(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Case previously recorded as MA2009-4588. Initial case report received from a physician on 17 NOV 2009. A patient 3-year-old younger was vaccinated with FLUVIRIN 2009/2010 i.m on 13 NOV 2009. No adverse effect was reported. Reference no: NA09-008308.
Age: 3.0
Sex: U
Vaccine: FLU(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Case previously recorded as MA2009-4589. Initial case report received from a physician on 17 NOV 2009. A patient 3-year-old younger was vaccinated with FLUVIRIN 2009/2010 i.m on 13 NOV 2009. No adverse effect was reported. NA09-008308.
Age: 3.0
Sex: U
Vaccine: FLU(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Case previously recorded as MA2009-4590. Initial case report received from a physician on 17 NOV 2009. A patient 3-year-old or younger was vaccinated with FLUVIRIN 2009/2010 i.m. on 13 NOV 2009. No adverse effect was reported. Reference no:NA09-008308.
Age: 3.0
Sex: U
Vaccine: FLU(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Administration to child under 4-year-old. Case previously recorded as MA2009-4591. Initial case report received from physician on 17 NOV 2009. A patient 3-year-old or younger was vaccinated with FLUVIRIN 2009/2010 i.m on 13 NOV 2009. No adverse effect was reported. Reference no: NA09-008308
Age: 3.0
Sex: U
Vaccine: FLU(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Case previously recorded as MA2009-4592. Initial case report received from a physician on 17 NOV 2009. A 3-year-old or younger patient was vaccinated with FLUVIRIN 2009/2010 i.m on 13 NOV 2009. No adverse events was reported. Reference no: NA09-008308.
Sex: U
Vaccine: FLU(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Case previously recorded as MA2009-4593. Initial case report received from a physician, on 17 NOV 2009. A patient (gender unknown) under 3 year-old was vaccinated with FLUVIRIN 2009/2010 (batch no. unknown) i.m., on 13 NOV 2009. No adverse event was reported. Reference no: NA09-008308.