chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 3.0
Sex: F
Vaccine: FLU3
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Case previously recorded as MA2009-5166. Initial case report received from a physician via agency, on 19 Nov 2009. A 3-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. Agency reference no.:NA09-008308.
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Case previously recorded as MA2009-5168. Initial case report received from a physician via agency, on 19 NOV 2009. The patient 3-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. Agency reference no.:NA09-008308.
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Case previously recorded as MA2009-5169. Initial case report received from a physician, via Novartis Medical Communication, on 20 Nov 2009. A 3-year-old male patient was vaccinated with 0.5 ml of S-OIV FLUVIRIN (batch no. 102124P1, expiration date 1 MAR 2010) i.m., an off-label indication. No adverse event was reported. Agency reference no.: NA09-008303.
Age: 2.0
Sex: F
Vaccine: FLU3
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Case previously recorded as MA2009-5170. Initial case report received from a physician, via Novartis Medical Communication on 20 NOV 2009. A 2 year-old female 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: 12.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Injection site reaction, Myalgia
Clinical narrative: Case previously recorded as MA2009-4409. Initial case report received from a consumer on 07 NOV 2009. A 12-year-old female patient was vaccinated with seasonal influenza on 12 OCT 09 and experienced local aching near the point of administration for a week. On 07 NOV 2009, the patient received S-OIV FLUVIRIN (batch no. unknown) and experienced local aching in the muscle tissue near the point of administration for about a week.
Age: 1.21
Sex: M
Vaccine: FLU3
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Case previously recorded as MA2009-5172. Initial case report received from a physician via MedCom on 19 NOV 2009. A 63 week-old male patient was vaccinated with S-OIV FLUVIRIN (batch no. 102124P1) i.m. on 13 NOV 2009. No adverse events were reported. MedCom reference no.: NA09-008308.
Sex: M
Vaccine: FLU3
Symptoms: Musculoskeletal stiffness, Pain
Clinical narrative: Case previously recorded as MA2009-4410. Initial case report received from a consumer on 07 NOV 2009. A male patient was vaccinated with S-OIV FLUVIRIN (batch no. unknown) on 12 OCT 2009. The patient experienced mild body aches and stiff neck on 13 OCT 2009, one day after the injection. The patient recovered.
Age: 2.0
Sex: M
Vaccine: FLU3
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Case previously recorded as MA2009-5220. Initial case report received from a physician via MedComon 19 OCT 2009. A 2 year-old 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.
Age: 1.93
Sex: M
Vaccine: FLU3
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Case previously recorded as MA2009-5221. Initial case report received from a physician via MedCom on 19 OCT 2009. A 23 month-old 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.
Age: 0.5
Sex: F
Vaccine: FLU3
Symptoms: Inappropriate schedule of drug administration, No adverse event, Off label use
Clinical narrative: Case previously recorded as MA2009-5223. Initial case report received from a physician via MedCom, on 19 OCT 2009. A 7 month-old female 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.
Age: 1.09
Sex: M
Vaccine: FLU3
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Case previously recorded as MA2009-5224. Initial case report received from a physician via agency, 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. Agency reference no.:NA09-008308.
Sex: F
Vaccine: FLU3
Symptoms: Nerve injury, Pain in extremity
Clinical narrative: Case previously recorded as MA2009-4490. Consumer reported the following information via MedCom on 17 NOV 2009: A female patient was vaccinated into the arm with influenza virus vaccine (manufacturer and batch no. unknown) on an unspecified date. While administering a nerve on the her arm was hit. She experienced pain in arm on an unknown date. The outcome of the symptom was unknown at reporting date. MedCom Ref. no.: NA09-008416.
Age: 0.78
Sex: F
Vaccine: FLU3
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Case previously recorded as MA2009-5227. Initial case report received from a physician via MedCom on 19 Oct 2009. A 10 month-old female 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.
Age: 19.0
Sex: M
Vaccine: FLU3
Symptoms: Paraesthesia oral, Swelling face, Urticaria
Clinical narrative: Case previously recorded as MA2009-4842. Initial case report received from a consumer's mother via Novartis Medical Communications, on 24 NOV 2009. A 19-year-old male patient was vaccinated for the first time with S-OIV FLUVIRIN (batch no. 102040P1) i.m on 14 NOV 2009. The patient experienced facial swelling, hives and lips tingling 2 hours after vaccination. The patient was treated with steroid injection and oral steroids. At the time of this report, the patient had not recovered. Novartis Medical Communication reference no.: NA09-008752.
Age: 1.71
Sex: F
Vaccine: FLU3
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Case previously recorded as MA2009-5228. Initial case report received from a physician via MedCom, on 19 NOV 2009. A 2-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: 1.17
Sex: M
Vaccine: FLU3
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Case previously recorded as MA2009-5229. Initial case report received from a physician, via Novartis Medical Communication on 20 NOV 2009. A 14 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: 3.0
Sex: F
Vaccine: FLU3
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Case previously recorded as MA2009-5230. Initial case report received from a physician via MedCom, on 19 NOV 2009. A patient 3-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.
Age: 3.0
Sex: F
Vaccine: FLU3
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Case previously recorded as MA2009-5233. Initial case report received from a physician via MedCom on 19 NOV 2009. A patient 3-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
Age: 59.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Application site hyperaesthesia, Injection site abscess, Injection site nodule, Injection site pustule, Injection site reaction
Clinical narrative: Case previously recorded as MA2009-4854. Initial case report received from a physician on 20 NOV 2009. A 59-year-old male patient was vaccinated with S-OIV FLUVIRIN (batch no. 1007396P) on 09 NOV 2009. On an unspecified date, he experienced muscle pain at injection site and injection site reaction (rash, erythema, nodular pustules). On 16 Nov 2009 the patient experienced subcutaneous painful nodules. On 17 Nov 2009, he developed vesicles and hyperthesia of the affected site. The physician reported that the patient had 4-5 lesions with neuropathic pain and neuritis. Further more the reporter stated that it looked like zoster. The outcome of patient was not reported.
Age: 59.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Injection site vesicles, Myalgia, Neuralgia, Neuritis, Rash erythematous
Clinical narrative: Case previously recorded as MA2009-4854. Initial case report received from a physician on 20 NOV 2009. A 59-year-old male patient was vaccinated with S-OIV FLUVIRIN (batch no. 1007396P) on 09 NOV 2009. On an unspecified date, he experienced muscle pain at injection site and injection site reaction (rash, erythema, nodular pustules). On 16 Nov 2009 the patient experienced subcutaneous painful nodules. On 17 Nov 2009, he developed vesicles and hyperthesia of the affected site. The physician reported that the patient had 4-5 lesions with neuropathic pain and neuritis. Further more the reporter stated that it looked like zoster. The outcome of patient was not reported.
Age: 59.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Skin lesion, Subcutaneous nodule
Clinical narrative: Case previously recorded as MA2009-4854. Initial case report received from a physician on 20 NOV 2009. A 59-year-old male patient was vaccinated with S-OIV FLUVIRIN (batch no. 1007396P) on 09 NOV 2009. On an unspecified date, he experienced muscle pain at injection site and injection site reaction (rash, erythema, nodular pustules). On 16 Nov 2009 the patient experienced subcutaneous painful nodules. On 17 Nov 2009, he developed vesicles and hyperthesia of the affected site. The physician reported that the patient had 4-5 lesions with neuropathic pain and neuritis. Further more the reporter stated that it looked like zoster. The outcome of patient was not reported.
Age: 1.02
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Case previously recorded as MA2009-5413. Case received on 23 NOV 2009 via MedCom from a healthcare professional the following information: A 12-month-old male patient was vaccinated i.m. with FLUVIRIN H1N1, batch no. 102125P1 (off label use), on 23 NOV 2009. No adverse events were reported. MedCom no: NA09-008745.
Age: 5.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Pyrexia, Rhinorrhoea
Clinical narrative: Case previously recorded as MA2009-5448. Case received on 24 NOV 2009 via MedCom from a consumer the following information: A 5-year-old male patient was vaccinated i.m. with FLUVIRIN H1N1, batch no. 102125P1, on 20 NOV 2009. The patient experienced on 22 NOV 2009 a runny nose and on 23 NOV 2009 in the morning fever. At the time of report, the patient did not yet recover. MedCom no: NA09-008739.
Age: 0.5
Sex: U
Vaccine: FLU(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Case previously recorded as MA2009-5489. Initial case report received from a healthcare professional on 20 NOV 2009. This 6-month-old child was vaccinated i.m. for the first time with S-OIV FLUVIRIN (batch no. unknown) in NOV 2009. No adverse event appeared. Reference no. NA09-008608.
Age: 3.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Case previously recorded as MA2009-5490. Initial case report received via Med Com from a health care professional on 20 NOV 2009: A 3-year-old male patient was vaccinated with S-OIV FLUVIRIN (batch no. 1008143P) on 19 NOV 2009. No adverse event was reported. MedCom ref. no.: NA09-008634.
Age: 1.33
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Case previously recorded as MA2009-5491. We received the following information from a consumer via Medical Communications (MedCom) on 19 NOV 2009: A 16-month-old male vaccinated i.m. with 0.25 ml of S-OIV FLUVIRIN (batch number unknown) on 14 NOV 2009. Administration of S-OIV FLUVIRIN to a child younger than four is not recommended/licensed. No adverse event had been reported. MedCom ref. no.: NA09-008551.
Age: 2.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Case previously recorded as MA2009-5492. Received the following information via Medical Communications (MedCom) from a healthcare professional on 20 NOV 2009: A 2-year-old female patient was vaccinated with an unknown dose of S-OIV FLUVIRIN (batch number unknown) on 19 NOV 2009. Administration of S-OIV FLUVIRIN is not recommended/licensed for children younger than four. No adverse effect was reported. MedCom ref. no: NA09-008612.
Age: 1.27
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Case previously recorded as MA2009-5496. Initial case report received from consumer on 21 NOV 2009. A 15-month old patient was vaccinated i.m for the first time with S-OIV FLUVIRIN on 19 Nov 2009.
Age: 7.0
Sex: M
Vaccine: FLU3
Symptoms: Exposure to communicable disease, Vomiting
Clinical narrative: Case previously recorded as MA2009-5497. Initial report received via MedCom, from a health care professional on 20 NOV 2009: A 7-year-old male patient was vaccinated with S-OIV FLUVIRIN (batch no. 1013263R) i.m. on 18 NOV 2009 at 3:00 p.m. On 19 NOV 2009 1:00 a.m. the patient experienced vomiting. It was reported that the patient was exposed to gastroenteritis during week before. The patient had recovered at reporting date. Ref. no.: NA09-008670.
Age: 89.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Activities of daily living impaired, Pain in extremity, Pyrexia
Clinical narrative: Initial report received from a health care professional on 06 Jan 2010: This patient's was vaccinated with FLUVIRIN on 08 Dec 2009. On 10 Dec 2009 the patient experienced upper and lower extremity pain which became progressively worse and debilitating to the point where she had difficulty dressing. On 31 Dec 2009 the patient experienced low grade persistent fever. The outcome for low grade persistent fever was not reported.
Age: 2.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event, Off label use
Clinical narrative: Case previously recorded as MA2009-5498. Initial case report received via Med Com from a health care professional on 20 NOV 2009: A 30-month-old male patient was vaccinated with 0.5 ml of FLUVIRIN (batch no. 102044P1) i.m. on 19 NOV 2009. No adverse event was reported. MedCom ref. no: NA09-008669.
Age: 2.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Case previously recorded as MA2009-5499. Initial case report received from consumer on 21 NOV 2009. 2 year old patient was vaccinated i.m. for the first time with S-OIV FLUVIRIN on 19 Nov 2009.
Age: 4.0
Sex: U
Vaccine: FLU(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Case previously recorded as MA2009-5502. Report received from a health care professional on 19 Nov 2009: Child under 4 years of age was vaccinated with FLUVIRIN on an unspecified date. No adverse event was reported. The outcome of the event was not rep[orted. Med-com reference number: NA09-008542.
Age: 44.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Grip strength decreased, Myalgia
Clinical narrative: Initial report was received from Pharmacist on 13 Jan 2010: This patient received FOCETRIA lot number 102142P1, intramuscular on 13 Jan 2010. The patient experienced muscle aches in her forearm and was "unable to pick anything up" on 13 Jan 2010. The outcome of the events was reported as ongoing.
Sex: F
Vaccine: FLU(H1N1)
Symptoms: No adverse event, Underdose
Clinical narrative: Case previously recorded as MA2009-5503. Received the following information from a health care professional via MedCom on 21 NOV 2009: A female adult patient was vaccinated with S-OIV FLUVIRIN (batch no. 102040P1) on an unknown date in 2009. Vaccine ran down arm and hand. No adverse event was reported. MedCom Ref. no.: NA09-008339.
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Case previously recorded as MA2009-5504. Initial case report received via healthcare professional on 19 Nov 2009. A 3-year-old male child was vaccinated with S-OIV FLUVIRIN (batch no. 10127803) on an unknown date. The recommended age is 4+. Nurse wanted to know, what she should do. The child tolerated vaccine and he was fine. Reference no.: NA09-008593.
Age: 2.0
Sex: U
Vaccine: FLU(H1N1)
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Case previously recorded as MA2009-5505. Received the following information from a consumer via Novartis Pharma on the 20 NOV 2009. This 2-year-old child gender unknown was inadvertently administered FLUVIRIN (batch number unknown) dosage unknown on 19 NOV 2009. The consumer refused to provide any other information, citing HIPAA violation even when she was told that it would not. The patient outcome is unknown.
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Case previously recorded as MA2009-5668. Case received on 20 NOV 2009 via MedCom, from a healthcare professional the following information: Male patient under 4 years was vaccinated i.m. with one dose of FLUVIRIN, batch no. 100813P, on 16 NOV 2009. No adverse events were reported. MedCom no:NA09-008579.
Age: 3.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Case previously recorded as MA2009-5674. Initial case report received via healthcare professional on 20 Nov 2009. An 8-year-old female child was vaccinated with S-OIV FLUVIRIN (batch no. 1008145P) on 16 Nov 2009. The recommended age is 4+. No adverse events reported. Company reference no.: NA09-008579.
Age: 74.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Rash
Clinical narrative: Initial report received from a consumer on 14 Jan 2010: This patient, with an unknown medical history, was vaccinated with FLUVIRIN 0.5 ml, intramuscularly on 21 Dec 2009. On 23 Dec 2009, she developed a rash on her left arm. The rash had progressively worsened, appearing on her right arm, trunk and legs. The outcome of the event was that the rash on her arms slowly disappearing, but was still present on other areas of her body.
Age: 42.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Pain in extremity
Clinical narrative: Initial report received from a healthcare professional on 20 Jan 2010: This patient received FLUVIRIN (batch number: unknown), unknown dose, intramuscular on 19 Dec 2009. On an unspecified date, a few hours after vaccination, the patient experienced pain in arm which comes and goes randomly. The outcome of the events was reported as ongoing.
Age: 52.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Erythema, Pruritus, Urticaria
Clinical narrative: Initial report received from consumer on 14 Jan 2010: This patient was vaccinated with FLUVIRIN, batch number 97851P1, unspecified dose intramuscular on 16 Oct 2009. On 26 Oct 2009, the patient experienced welts, itchiness and redness in different places each day beginning. On 11 Jan 2010, the patient was diagnosed with Urticaria. The outcome of the events was reported as ongoing. Following internal review of the data on 29 Jan 2010, it was noticed that the manufacturer receipt date of the initial report received on 13 Jan 2010 had been incorrectly presented as 14 Jan 2010. The correct receipt date was 13 Jan 2010.
Sex: U
Vaccine: FLU3
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Case previously recorded as MA2009-6259. Initial case report received from a health care professional on 25 NOV 2009. Twenty children younger than 04 years of age received FLUVIRIN intramuscular inadvertent administration on an unknown date. No adverse events reported. Medical history: Not reported. Reference no. NA09-008851.
Age: 73.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Rash
Clinical narrative: Initial report received from a consumer (Patient's husband) on 29 Jan 2010: This patient was vaccinated with FLUVIRIN intramuscular, dose unknown 02 weeks ago (exact date not reported). The patient developed rash on thighs within 24 hrs of vaccination. The outcome of the event was reported as condition Unchanged.
Sex: U
Vaccine: FLU(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Case previously recorded as MA2009-6260. Initial case report received from a health care professional on 25 NOV 2009. Twenty children younger than 04 years of age received FLUVIRIN intramuscular inadvertent administration on an unknown date. No adverse events reported. Medical history: Not reported. Reference no. NA09-008851.
Age: 42.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Rash
Clinical narrative: Initial health care professional report received on 19 Jan 2010: This patient was vaccinated with FLUVIRIN (batch number 104043P1 on 04 Jan 2010, intramuscularly. On 04 Jan 2010, the patient presented with slight bump that looked like a mosquito bite. The outcome of the event was not reported. The seriousness criteria of the events was not reported.
Sex: U
Vaccine: FLU3
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Case previously recorded as MA2009-6261. Initial case report received from a health care professional on 25 NOV 2009. Twenty children younger than 04 years of age received FLUVIRIN intramuscular inadvertent administration on an unknown date. No adverse events reported. Medical history: Not reported. Reference no. NA09-008851.
Age: 44.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Pain, Pain in extremity
Clinical narrative: Initial report received from a healthcare professional on 08 Feb 2010: This patient with unknown medical history was vaccinated with S-OIV FLUVIRIN (batch no. 104043P1), IM, on 19 Jan 2010. This patient experienced soreness in the arm and when he moved it was still sore on 19 Jan 2010. Outcome of event was not reported. Following an internal review on 13 Apr 2010 of the information received on 08 Feb 2010, it was noted that the vaccine S-OIV FLUVIRIN was incorrectly coded as seasonal influenza vaccine. Therefore, it was correctly recoded to S-OIV FLUVIRIN.
Sex: U
Vaccine: FLU(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Case previously recorded as MA2009-6262. Initial case report received from a health care professional on 25 NOV 2009. Twenty children younger than 04 years of age received FLUVIRIN influenza A intramuscular inadvertent administration on an unknown date. No adverse events reported. Medical history: Not reported. Agency reference no. NA09-008851.
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Pain in the injection site shortly after the injection. Initial health care professional report received on 09 Feb 2010: This patient was vaccinated with FLUVIRIN, (batch no unknown), 0.5 ml intramuscular in left deltoid on 20 Jan 2010 (possibly). On 20 Jan 2010, the patient experienced pain at the injection site after the vaccination. The outcome of the event was reported as condition unchanged.
Sex: U
Vaccine: FLU3
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Case previously recorded as MA2009-6263. Initial case report received from a health care professional on 25 NOV 2009. Twenty children younger than 04 years of age received FLUVIRIN intramuscular inadvertent administration on an unknown date. No adverse events reported. Medical history: Not reported. Reference no. NA09-008851.
Sex: U
Vaccine: FLU3
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Case previously recorded as MA2009-6264. Initial case report received from a health care professional on 25 NOV 2009. Twenty children younger than 04 years of age received FLUVIRIN intramuscular inadvertent administration on an unknown date. No adverse events reported. Medical history: Not reported. Agency reference no. NA09-008851.
Sex: U
Vaccine: FLU(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Case previously recorded as MA2009-6265. Initial case report received from a health care professional on 25 NOV 2009. Twenty children younger than 04 years of age received FLUVIRIN intramuscular inadvertent administration on an unknown date. No adverse events reported. Medical history: Not reported. Agency reference no. NA09-008851.
Sex: U
Vaccine: FLU3
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Case previously recorded as MA2009-6266. Initial case report received from a health care professional on 25 NOV 2009. Twenty children younger than 04 years of age received FLUVIRIN intramuscular inadvertent administration on an unknown date. No adverse events reported. Medical history: Not reported. Agency reference no. NA09-008851.
Sex: U
Vaccine: FLU(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Case previously recorded as MA2009-6267. Initial case report received from a health care professional on 25 NOV 2009. Twenty children younger than 04 years of age received FLUVIRIN intramuscular inadvertent administration on an unknown date. No adverse events reported. Medical history: Not reported. Reference no. NA09-008851.
Sex: U
Vaccine: FLU(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Case previously recorded as MA2009-6268. Initial case report received from a heath care professional on 25 NOV 2009. Twenty children younger than 04 years of age received FLUVIRIN intramuscular inadvertent administration on an unknown date. No adverse events reported. Medical history: Not reported. Reference no. NA09-008851.
Sex: U
Vaccine: FLU3
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Case previously recorded as MA2009-6269. Initial case report received from a health care professional on 25 NOV 2009. Twenty children younger than 04 years of age received FLUVIRIN intramuscular inadvertent administration on an unknown date. No adverse events reported. Medical history: Not reported. Reference no. NA09-008851.
Sex: U
Vaccine: FLU(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Case previously recorded as MA2009-6270. Initial case report received from a health care professional on 25 NOV 2009. Twenty children younger than 04 years of age received FLUVIRIN intramuscular inadvertent administration on an unknown date. No adverse events reported. Medical history: Not reported. Reference no. NA09-008851.
Sex: U
Vaccine: FLU(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Case previously recorded as MA2009-6271. Initial case report received from a health care professional on 25 NOV 2009. Twenty children younger than 04 years of age received FLUVIRIN intramuscular inadvertent administration on an unknown date. No adverse events reported. Medical history: Not reported. Reference no. NA09-008851.
Sex: U
Vaccine: FLU(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Case previously recorded as MA2009-6272. Initial case report received from a health care professional on 25 NOV 2009. Twenty children younger than 04 years of age received FLUVIRIN influenza A intramuscular inadvertent administration on an unknown date. No adverse events reported. Medical: Not reported. Agency reference no. NA09-008851.
Sex: F
Vaccine: FLU3
Symptoms: Drug exposure during pregnancy, No adverse event
Clinical narrative: Case previously recorded as MA2009-3338. A consumer reported the following information via MedCom on 28 OCT 2009: A pregnant, female patient was vaccinated i.m. with S-OIV-FLUVIRIN (batch no. unknown) into the right deltoid on 28 OCT 2009. No adverse event was reported. MedCom Ref. no: NA09-007146.
Sex: U
Vaccine: FLU(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Case previously recorded as MA2009-6273. Initial case report received from a health care professional on 25 NOV 2009. Twenty children younger than 04 years of age received FLUVIRIN influenza A intramuscular inadvertent administration on an unknown date. No adverse event reported. Medical history: No reported. Agency reference no. NA09-008851.
Age: 42.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Body temperature increased
Clinical narrative: Case previously recorded as MA2009-3455. The health care professional reported the following information via MedCom, on 30 OCT 2009: A 42-year-old male patient was vaccinated i.m. with Novartis  H1N1 vaccine (batch no. 101716P1A) on 29 OCT 2009. He developed a temperature of 100 F about four to five hours after vaccination. He recovered on 30 OCT 2009. MedCom Ref. no. NA09-007295.
Age: 3.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Case previously recorded as MA2009-5680. Initial case report received via healthcare professional on 20 Nov 2009. An 8-year-old male child was vaccinated with S-OIV FLUVIRIN (batch no. 1008145P) on 18 Nov 2009. The recommended age is 4+. No adverse events reported. Company reference no.: NA09-008579.
Age: 3.0
Sex: F
Vaccine: FLU3
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Case previously recorded as MA2009-5687. Received on 20 NOV 2009 via MedCom, from a healthcare professional the following information: A 3-year-old female patient was vaccinated i.m. with 0.5ml FLUVIRIN, batch no. 10127801, on 20 NOV 2009. No adverse events were reported. MedCom no: NA09-008676.
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Case previously recorded as MA2009-5694. Case received on 20 NOV 2009 via MedCom, from a healthcare professional the following information: A 3-year-old male patient was vaccinated i.m. with 0.5ml FLUVIRIN, batch no. 10127801, on 20 NOV 2009. No adverse events were reported. MedCom no.: NA09-008676.
Age: 3.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Case previously recorded as MA2009-5698. We received the following information via a health care provided from Novartis Pharma on the 24 NOV 2009. This 3-year child was vaccinated with FLUVIRIN (batch number 10073801AN) on 24-Nov-2009 for off label use. There was no event associated with this use. Novartis Vaccines ref no. NA09-008786.
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Case previously recorded as MA2009-5699. We received the following information from a consumer via LAREB, and Novartis Pharma on the 20 NOV 2009. This 3-year-old male patient, was vaccinated with 1 DF S-OIV FLUVIRIN (batch number 1012781) on an unknown date. Ref no. NA09-008676.
Age: 10.0
Sex: M
Vaccine: FLU(H1N1), FLU3
Symptoms: Cough, Dyspnoea, Ocular hyperaemia
Clinical narrative: Case previously recorded as MA2009-3484. The nurse reported the following information via MedCom on 30 OCT 2009: A 10-year-old male child, was vaccinated simultaneously i.m. with S-OIV FLUVIRIN (batch no. possibly 9721503) and FLUVIRIN (batch no. possibly 9721503) on 29 SEP 2009. He experienced coughing, blood shot eyes and breathing difficulties later in the evening. He was taken as an outdoor patient to emergency department where he was treated with an unspecified steroid. He had fully recovered on 30 OCT 2009. It was unclear whether the reported batch no. belonged to H1N1 or influenza vaccine. MedCom Ref. no.: NA09-007359.
Sex: M
Vaccine: FLU3
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Case previously recorded as MA2009-5701. We received the following information from a consumer via LAREB, and Novartis Pharma on the 20 NOV 2009. This patient was vaccinated with 1 DF S-OIV FLUVIRIN (batch number 10127801) on an unknown date. Ref no. NA09-008676.
Age: 38.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Drug exposure during pregnancy, No adverse event
Clinical narrative: Case previously recorded as MA2009-3668. We received via MedCom the following information on 03 NOV 2009: A 38-year-old female patient, was vaccinated with SOIV FLUVIRIN i.m. on 30 OCT 2009. The patient was pregnant during vaccine exposure (gestational age 6.5 months). No adverse event was reported. MedCom ref. no. NA09-007512.
Sex: U
Vaccine: FLU(H1N1)
Symptoms: Incorrect route of drug administration
Clinical narrative: Case previously recorded as MA2009-5707. We received the following information from a Medical Center via MedCom, on 24 NOV 2009. This patient, age and date of birth unknown, was vaccinated with S-OIV FLUVIRIN (batch number unknown) subcutaneously on an unknown date. The vaccine was inadvertently administered subcutaneously (vaccine was supposed to be administered intramuscularly). Patient information was refused to the reporter. Patient outcome was not applicable, as there was no event. Agency Reference no.: NA09-008762.
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Case previously recorded as MA2009-5708. Case received on 20 NOV 2009 via MedCom from a healthcare professional the following information: A 3-year-old male patient was vaccinated i.m. with 0.5ml FLUVIRIN, batch no. 10127801, on 20 NOV 2009. No adverse events were reported. MedCom no:NA09-008676.
Age: 19.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Injection site pruritus, Injection site rash, Injection site urticaria, Rash pruritic, Urticaria
Clinical narrative: Case previously recorded as MA2009-3671. Case received from a health care professional via agency, the following information on 03 NOV 2009: 19-year-old female patient was vaccinated for the first time with H1N1 SOIV FLUVIRIN i.m. into right deltoid on 02 NOV 2009. Approximately two hours later she developed hives and itchy rash which ran from the injection site to her right hand. The patient had not recovered at reporting date on 03 NOV 2009. Agency ref no. NA09-007461.
Age: 0.5
Sex: U
Vaccine: FLU(H1N1)
Symptoms: Accidental exposure, Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Case previously recorded as MA2009-5709. We received the following information from a physician via agency, on 24 NOV 2009. This 6-month-old patient (unknown gender), was vaccinated with S-OIV FLUVIRIN (batch number unknown) intramuscularly on an unknown date. The vaccine was inadvertently administered. Patient information was refused to the reporter. Patient outcome was not applicable, as there was no event. Reference no: NA09-008755.
Age: 32.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Drug exposure during pregnancy, No adverse event
Clinical narrative: Case previously recorded as MA2009-3675. Consumer reported the following information via MedCom on 4 NOV 2009: A 33-year-old female patient, who was in the sixth month of her pregnancy was vaccinated i.m. with S-OIV-FLUVIRIN (batch no. unknown) on 3 NOV 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: Case previously recorded as MA2009-5719. Initial case report received from a healthcare professional on 20 NOV 2009. This 3-year-old male child was vaccinated for the first time with S-OIV FLUVIRIN (batch no. 10127801) on 20 NOV 2009. No adverse event appeared. Reference no. NA09-008676.
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Paraesthesia
Clinical narrative: Case previously recorded as MA2009-3683. Consumer reported the following information via MedCom, on 3 NOV 2009: A female patient with a known history of Parkinson's disease (diagnosed about one year ago) was vaccinated i.m. with S-OIV FLUVIRIN (batch no. 101716P1A) on 26 or 30 OCT 2009. When returning to her car shortly after vaccination she developed a tingling sensation in her left foot lasting for approximately ten minutes. She had fully recovered on 26 or 30 OCT 2009. MedCom Ref. no.: NA09-007532. Addendum: We received the following additional information via MedCom on 5 NOV 2009: Tingling sensation resolved and had not yet returned. No change in assessment.
Age: 2.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Case previously recorded as MA2009-5721. Initial case report received from a healthcare professional on 20 NOV 2009. This 2-year-old female child was vaccinated for the first time with S-OIV FLUVIRIN (batch no. 10127801) on 20 NOV 2009. No adverse event appeared. Reference no. NA09-008676.
Age: 1.18
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Case previously recorded as MA2009-5997. Initial case report received via agency, from a health care professional on 24 NOV 2009: A 14-month-old boy, was vaccinated with S-OIV FLUVIRIN (batch no. 102127P1) on 23 NOV 2009. No adverse event was reported. Agency ref. no.: NA09-008811.
Age: 52.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Urticaria
Clinical narrative: Case previously recorded as MA2009-3693. A health care professional reported the following information via MedCom, on 4 NOV 2009: A 52-year-old female patient was vaccinated i.m. with S-OIV FLUVIRIN (batch no. unknown) on 28 OCT 2009. She developed large raised hives on her trunk and legs on 1 NOV 2009 (as start date 28 OCT 2009 was also reported). She had not recovered at reporting date. MedCom Ref. no.: NA09-007569. Follow up report received on 26 Apr 2010: Follow-up with reporter was attempted, but no response received so far. Therefore the case was closed with consideration as lost to follow-up.
Age: 62.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: No adverse event, Underdose
Clinical narrative: Case previously recorded as MA2009-6109. Case received on 25 NOV 2009 via agency from a healthcare professional the following information: A 62-year-old male patient was vaccinated i.m. with a partial dose FLUVIRIN, batch no. unknown on an unknown date. No adverse events were reported. MedCom no:NA09-008801.
Age: 22.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Drug exposure during pregnancy, Influenza like illness
Clinical narrative: Case previously recorded as MA2009-3708. A nurse reported the following information via MedCom on 5 NOV 2009: A 22-year-old pregnant patient was vaccinated i.m. with S-OIV-FLUVIRIN (batch no. unknown) on 4 NOV 2009. She developed flu-like symptoms on 5 NOV 2009. She had not recovered at reporting date. MedCom Ref. no.: NA09-007664.
Sex: U
Vaccine: FLU(H1N1)
Symptoms: Unevaluable event
Clinical narrative: Case previously recorded as MA2009-6257. Initial case report received from a health care professional on 25 NOV 2009. Twenty children younger than 04 years of age received FLUVIRIN influenza A intramuscular inadvertent administration on an unknown date. No adverse events reported. Medical history: Not reported. Agency reference no. NA09-008851.
Sex: U
Vaccine: FLU(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Case previously recorded as MA2009-6258. Initial case report received from a health care professional on 25 NOV 2009. Twenty children younger than 04 years of age received FLUVIRIN intramuscular inadvertent administration on an unknown date. No adverse events reported. Medical history: Not reported. Reference no. NA09-008851.
Age: 29.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Breast feeding, No adverse event
Clinical narrative: Case previously recorded as MA2009-3709. A health care professional reported the following information via MedCom, on 5 NOV 2009: A 29-year-old breast-feeding female patient with a seven week-old baby was vaccinated i.m. with one dose of S-OIV FLUVIRIN (batch no. unknown) on an unknown date in 2009. No adverse event was reported. MedCom Ref. no.: NA09-007632.
Sex: F
Vaccine: FLU3
Symptoms: Drug exposure during pregnancy, No adverse event
Clinical narrative: Case previously recorded as MA2009-3726. Initial case report received from a consumer, via Novartis Medical Communications, on 04 NOV 2009. A female patient was vaccinated with S-OIV FLUVIRIN (batch no. unknown) on an unknown date, while 6 months pregnant. No adverse event was reported. Agency reference no.: NA09-007580.
Age: 5.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Injection site erythema, Injection site swelling, Similar reaction on previous exposure to drug
Clinical narrative: Case previously recorded as MA2009-3747. Case received on 06 NOV 2009 from a consumer the following information: A 5-year-old male patient was vaccinated with H1N1 (manufacture and batch no. unknown), on an unknown date. The patient experienced the following day a swollen and red area around the shot, approx.2" circle. The outcome is unknown. The same reaction occurrs after the vaccination with seasonal Influenza vaccine, see case MA2009-3749.
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Feeling cold, Injection site pain, Pain
Clinical narrative: Case previously recorded as MA2009-3751. Received on 06 Nov 2009 from a consumer the following information: A female patient was vaccinated with H1N1 (manufacturer and batch no. unknown) on an unknown date. The patient experienced on an unknown date pain in the arm (injection site) for about 4 days and achy and cold at night. The outcome is unknown.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Case previously recorded as MA2009-3757. Initial case report received from a nurse, on 10 NOV 2009. A 36 year-old female patient was vaccinated with 0.5ml of S-OIV FLUVIRIN (batch no. 101716P1A) i.m. on 29 OCT 2009. On 03 NOV2009, 5 days after vaccination, the patient experienced soreness of the left upper extremity. The outcome of the event was reported as recovered.
Age: 4.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Pyrexia
Clinical narrative: Initial report received from healthcare professional on 16 Feb 2010: This patient with unknown medical history was vaccinated with S-OIV FLUVIRIN (batch no. 102046P1), 0.5ml, IM, on 18 Nov 2009. The patient experienced low grade fever (99 F) on 19 Nov 2009. Outcome of event was reported ongoing.
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: Initial report received from a pharmacist on 04 Mar 2010: This patient was vaccinated with FLUVIRIN 0.5 ml intramuscular injection, on an unspecified date in Nov 2009. The patient had experienced injection site pain on an unspecified date in Nov 2009. According to the reporter, the patient continued to experience pain in his arm near the site of injection. The outcome of the event was not reported. The seriousness criteria of the event was not reported and no further information was provided at the time of report.
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Injection site pain
Clinical narrative: Initial healthcare professional report was received on 04 Mar 2010: This patient was vaccinated with FLUVIRIN, batch no: unknown, 0.5 ml, intramuscular, on an unknown date. In Nov 2009 (day unknown), the patient experienced injection site pain in their arms near the sites of injection. The outcome of the events were not reported.
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Urticaria
Clinical narrative: Initial report was received from a health care professional on 08 Mar 2010: This patient received with FLUVIRIN in Feb 2010. After couple of hours of vaccination the patient experienced hives on her trunk, arms and legs. The patient was administered epinephrine as treatment drug. The outcome of the event was reported as complete recovery.
Age: 32.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Food allergy, Milk allergy, Pruritus, Rash
Clinical narrative: Initial consumer report received on 10 Mar 2010: This patient received FLUVIRIN (batch number unknown), unknown dose, intramuscular on 28 Nov 2009. On an unknown date, two weeks later after vaccination in Dec 2009, the patient experienced rash on arms, armpits, and legs and got itchy, 3 to 6 hours after consumption of shellfish, beer, steak, beef, and milk. It was reported that the patient experienced the above reactions whenever the patient consume any of the above-listed foods and beverages. It was reported that the patient had never experienced this reaction's prior to receiving the vaccine, and that the patient was able to consume these items prior to receiving the vaccine without any reactions. The outcome of the events was reported.
Age: 32.0
Sex: M
Vaccine: FLU3
Symptoms: Nonspecific reaction, Pruritus, Rash
Clinical narrative: Initial report received from a consumer on 10 Mar 2010: This patient was vaccinated with FLUVIRIN, (batch no: unknown), (dose: unknown), intramuscularly on 28 Nov 2009. Two weeks later on an unspecified date in Dec 2009 the patient developed reaction 3 to 7 hours after consumption of certain foods and beverages. The patient stated that he had itching and developed a rash on his arms, armpits and legs after consuming shellfish, beer, steak, beef and milk. The patient reported that the reaction happens in response to consumption of any of the above listed foods and beverages, the patient never had these problems prior to receiving the vaccine and he was able to consume these items prior to receiving the vaccination without any reaction. The outcome of the events were not reported. Following an internal review on 07 May 2010 of the data received on 10 Mar 2010, following correction was made. The event was recoded from two weeks later he developed reaction to allergic skin reaction.
Age: 48.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Rash pruritic
Clinical narrative: Initial consumer report received on 26 Mar 2010: This patient was vaccinated with S-OIV FLUVIRIN (batch no. unknown), 0.5 ml, intramuscular, on 19 Jan 2010. On 19 Jan 2010, the patient experienced rash that lasted until roughly on 03 Feb 2010 and the rash which was itchy, diffuse and gradually disappeared through prednisone administered (date not specified) by physician. It was determined that, the patient was allergic to thimerosal. The outcome of events were reported complete recovery on 03 Feb 2010.
Sex: U
Vaccine: FLU(H1N1)
Symptoms: Injection site erythema
Clinical narrative: Initial report received from pharmacist on 18 Jun 2010: This patient received S-OIV FLUVIRIN vaccine (batch number not reported) on an unknown date. The patient developed redness at the injection site that stayed for quite a while on an unknown date. The causality was not reported.
Age: 2.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Case previously recorded as MA2009-5165. Initial case report received from a physician via agency on 19 NOV 2009. 2-year-old female patient was vaccinated with S-OIV FLUVIRIN (batch no. 102124P1) i.m. on 13 NOV 2009. No adverse events were reported. Agency reference no.: NA09-008308.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Headache, Malaise, Nausea
Clinical narrative: Case previously recorded as MA2009-3758. Initial case report received from a registered nurse on 10 NOV 2009. A 56-year-old female patient was vaccinated with S-OIV FLUVIRIN (batch no. 101716P1A) i.m. into the left deltoid on 26 OCT 2009. The patient woke up feeling dizzy 48 to 72 hours after vaccination. She also had nausea, headache and malaise. The symptoms resolved after 12 to 16 hours.