chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 87.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: No reaction on previous exposure to drug, Sedation
Clinical narrative: Initial report received from a healthcare professional on 15 Jan 2010: This polymedicated patient had a medical history of type II diabetes, hypertension (HTN), congestive heart failure (CHF), chronic obstructive pulmonary disease (COPD), gastro-esophageal reflux disease (GERD), hyperlipidemia, anemia, Parkinson's disease, gout, renal insufficiency and psoriasis. The patient had received influenza vaccine in past season without any adverse event. The patient vaccinated with FLUVIRIN  (lot number: 102132P1) on 13 Jan 2010. Following FLUVIRIN administration, the patient experienced a seizure, with a latency of 4 hours and hospitalized. The patient had no history of seizure or epilepsy. An electro-encephalogram (EEG)  after the seizure showed no epileptic activity. The patient was on a ventilator in the intensive care unit and was treated with antiepileptic medications and antibiotics because of possible aspiration during the seizure. The patient was sedated and did not return to baseline mental status since the seizure. Outcome of the events was reported as condition unchanged. Follow up report received on 23 Apr 2010: Two requests for follow-up information were sent on 09 Feb 2010 and 29 Mar 2010 respectively, but no reply had been received. Hence the case was closed due to the lack of response.
Sex: U
Vaccine: FLU(H1N1)
Symptoms: Guillain-Barre syndrome
Clinical narrative: Initial healthcare professional report received on 19 Feb 2010: This patient was vaccinated with FLUVIRIN (batch no unknown) on an unspecified date. The patient acquired Guillain-Barre disease shortly after receiving the vaccine. The outcome of the event was not reported. Follow up report received on 14 May 2010: Two follow-up requests were sent to the report but no response received so far. Hence the case was closed due to lack of response.
Age: 34.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Immediate post-injection reaction, Injection site mass, Injection site reaction, Muscle injury, Pain in extremity
Clinical narrative: Initial report received from a consumer (patient) on 23 Apr 2010: This patient was vaccinated with FLUVIRIN (batch no: unknown), intramuscular, on 13 Jan 2010. On 13 Jan 2010, the patient experienced soreness in arm (immediately after vaccination), feel like damage to the muscle where the vaccine was injected and lump at the injection site. The patient reported that events to treating physician (who is endocrinologist). The outcome of the event soreness in arm was reported as condition unchanged and outcome of the other events were not reported. Follow up report received from an endocrinologist on 03 May 2010: Batch number of FLUVIRIN was provided as 02147P1. The patient presented with persisting arm swelling and pain at the site of vaccination. The patient was advised to go to primary care doctor. Outcome of events were unknown. The reporter assessed the events as medically significant.
Age: 34.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: Initial report received from a consumer (patient) on 23 Apr 2010: This patient was vaccinated with FLUVIRIN (batch no: unknown), intramuscular, on 13 Jan 2010. On 13 Jan 2010, the patient experienced soreness in arm (immediately after vaccination), feel like damage to the muscle where the vaccine was injected and lump at the injection site. The patient reported that events to treating physician (who is endocrinologist). The outcome of the event soreness in arm was reported as condition unchanged and outcome of the other events were not reported. Follow up report received from an endocrinologist on 03 May 2010: Batch number of FLUVIRIN was provided as 02147P1. The patient presented with persisting arm swelling and pain at the site of vaccination. The patient was advised to go to primary care doctor. Outcome of events were unknown. The reporter assessed the events as medically significant.
Age: 52.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Disturbance in attention, Hyperhidrosis, Injection site pain, Injection site reaction, Migraine
Clinical narrative: Initial Health Authority report received on 11 Jan 2010: This patient had vaccination history of FLUVIRIN with adverse events fever, headache, dizziness, muscle aches and inability to concentrate or focus on an unspecified date (case: PHHY2010US49621). This patient had received Hepatitis, Tetanus and Tuberculosis immunizations in Aug 2009. She had allergy to penicillin, CODEINE and shell fish. The patient received H1N1 (batch number unknown), on 02 Dec 2009. She experienced sweat profusely and the injection site became sore with muscle pain and burning. She began to loose ability to concentrate and focus on 02 Dec 2009. The patient also got a migraine type headache with blurred vision. The patient visited emergency room. She was treated with BENADRYL, 25 mg, 2 capsules, and every 4 hours orally until on visit on 03 Dec 2009. After medical examination, the patient received MEDROL dose pack (6 days decreasing) from on an unspecified date and still ongoing. The seriousness criterion reported as life threatening. The outcomes of events were reported as unknown.
Age: 52.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Myalgia, Vision blurred
Clinical narrative: Initial Health Authority report received on 11 Jan 2010: This patient had vaccination history of FLUVIRIN with adverse events fever, headache, dizziness, muscle aches and inability to concentrate or focus on an unspecified date (case: PHHY2010US49621). This patient had received Hepatitis, Tetanus and Tuberculosis immunizations in Aug 2009. She had allergy to penicillin, CODEINE and shell fish. The patient received H1N1 (batch number unknown), on 02 Dec 2009. She experienced sweat profusely and the injection site became sore with muscle pain and burning. She began to loose ability to concentrate and focus on 02 Dec 2009. The patient also got a migraine type headache with blurred vision. The patient visited emergency room. She was treated with BENADRYL, 25 mg, 2 capsules, and every 4 hours orally until on visit on 03 Dec 2009. After medical examination, the patient received MEDROL dose pack (6 days decreasing) from on an unspecified date and still ongoing. The seriousness criterion reported as life threatening. The outcomes of events were reported as unknown.
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Myelitis transverse, Pain, Paralysis
Clinical narrative: Initial report received from a consumer on 13 Aug 2010: This patient with unknown medical history was vaccinated with H1N1 vaccine (manufacturer and batch number unknown) on 18 Nov 2009. Ten days after the vaccination, the patient was paralyzed from breast to toes and suffered from permanent disability and continual pain. The patient was hospitalized. A diagnosis of acute transverse myelitis was made. The patient was treated with rehabilitation and physical therapy. Final outcome of the events was not reported.
Age: 49.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Initial report received from a health care professional on 09 Feb 2010: It was reported that, the patient was vaccinated with H1N1 (batch no: 1009232P), intramuscularly 2 doses inadvertently. Event outcome was not reported on 07 Feb 2010.
Age: 3.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Initial report received from a health care professional on 09 Feb 2010: It was reported that a 3 year old child was vaccinated with H1N1 vaccine (batch no: 102143P1), 0.25 or 0.5 ml IM dose, inadvertently. It was also reported that, the patient was unsure of dose administered because it was done at another facility, but the patient knows that it was a Novartis product. The outcome of the event was not reported.
Age: 46.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Accidental exposure, Eye irritation
Clinical narrative: Initial report was received from a health care professional on 10 Feb 2010: It was reported that caller had withdrawn a 0.5 mL dose of S-OIV FLUVIRIN batch no. 102149P1 out of a syringe to administer to a patient on 10 Feb 2010. While she was tapping on the side of the syringe barrel to get some bubbles out of the solution, some vaccine emerged from the tip of the syringe and splashed caller in the left eye. Caller stated that the left corner of her eye was slightly irritated and had burning sensation. Caller stated that she washed the area thoroughly but it seems some resolution of side effect. The outcome of the event was reported as ongoing.
Age: 16.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Initial health care professional report received on 10 Feb 2010: This patient was inadvertently vaccinated with FLUVIRIN, 0.5 ml, intramuscular on 09 Feb 2010, the patient had already received vaccination in December (manufacture unknown). No adverse event was reported.
Age: 65.0
Sex: U
Vaccine: FLUX(H1N1)
Symptoms: Dysphonia
Clinical narrative: Initial report received from a consumer on 12 Feb 2010: This patient was vaccinated with H1N1 vaccine (manufacturer unknown) on 17 Jan 2010. On the same day the patient was presented with hoarse voice. The patient outcome was reported as condition unchanged.
Age: 2.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Off label use
Clinical narrative: Initial report received from a health care professional on 12 Feb 2010: This 2 year old patient was vaccinated with FLUVIRIN (batch no. 102131P1) on 11 Feb 2009. The patient's outcome was not reported.
Age: 9.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Initial report received from a health care professional on 11 Feb 2010: This patient was vaccinated with FLUVIRIN (batch no: 102149P1), that was stored up to 71 F for up to 13 hours. The patient received 0.5 ml, intramuscular on 09 Feb 2010. No adverse reactions were reported.
Age: 1.36
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Initial health care professional report received on 11 Feb 2010: This patient who had already received Sanofi H1N1 vaccine on 26 Oct 2009, received FLUVIRIN second dose (batch number 102133P1) 0.25 ml, intramuscular on 30 Nov 2009. On 30 Nov 2009, the patient (18 month old) received 0.25 ml of Novartis H1N1 as second dose. No other adverse event was reported.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Initial report received from nurse practitioner on 11 Feb 2010: This patient received a dose of FLUVIRIN, (batch no: 102149P1), (expiration date 30 Apr 2010), 0.5 ml, intramuscular that was stored at temperature, up to 71 F for up to 13 hours. No adverse reactions were reported.
Age: 13.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Initial report received from nurse on 16 Feb 2010: This patient received one dose of Sanofi H1N1 vaccine on 28 Nov 2009. He inadvertently received a second dose of FLUVIRIN, 0.5 ml, on 28 Jan 2010. No adverse events were noted after administration of both vaccines.
Age: 11.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Initial report received from nurse on 16 Feb 2010: The patient received 0.5 ml of FLUVIRIN on 03 Dec 2009 (Batch no. 102040P1). On 20 Jan 2010, again he received same vaccine. No adverse events were reported after administration of either dose.
Age: 3.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Initial report was received from the Nurse on 17 Feb 2010: This patient (under four years of age) was vaccinated with 0.5 ml of FLUVIRIN (batch number 102138P1A), intramuscularly on 16 Feb 2010. The outcome of patient's condition was not reported.
Age: 5.0
Sex: U
Vaccine: FLU(H1N1)
Symptoms: Expired drug administered, No adverse event
Clinical narrative: Initial report from a health care professional (medical assistant) on 27 Apr 2010: This child was vaccinated with expired S-OIV FLUVIRIN, (batch no: 102046p1, with a expiration date of 31 Mar 2010), (dose: 0.5 ml) intramuscularly on 26 Apr 2010. No adverse reaction had occurred.
Sex: U
Vaccine: FLU(H1N1)
Symptoms: Expired drug administered, No adverse event
Clinical narrative: Initial report received from a healthcare professional on 03 May 2010: This patient was vaccinated with S-OIV FLUVIRIN, batch no: 101330, intramuscularly, on 03 May 2010. The patient inadvertently received a 0.5 mL intramuscular dose of expired H1N1 vaccine. No adverse effects were noted. The outcome of the event was not reported.
Age: 42.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Expired drug administered
Clinical narrative: Initial health care professional report received on 11 May 2010: This patient received S-OIV FLUVIRIN (batch number 1013306P) 0.5 ml dose, intramuscular on 05 May 2010, which got expired in Apr 2010. No other information was provided. Follow up report received from healthcare profession on 02 Jun 2010: The vaccination time added as 11:19 and no other new medical significant information received so it considered to be a non significant follow up.
Age: 10.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Expired drug administered
Clinical narrative: Initial report received from a health care professional on 17 May 2010: This patient, with an unknown medical history was inadvertently administered a dose of expired FLUVIRIN; (Batch no. 1013291P), intramuscularly on 13 May 2010. The outcome of the event was not reported. No other information was provided.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: Initial case report received from a nurse on 18 May 2010: This patient was inadvertently vaccinated with expired S-OIV FLUVIRIN, (batch no. 1013292P) 0.5 ml intramuscularly on an unspecified date. According to the reporter, no adverse events were noted after the vaccine administration. The outcome of the event was not reported.
Age: 49.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Expired drug administered, No adverse event
Clinical narrative: Initial report received from a health care professional (nurse) on 21 May 2010: This patient was vaccinated with expired S-OIV FLUVIRIN, (batch no: 102142P1), (dose: 0.5 ml) intramuscularly on an unspecified date. No adverse reaction had occurred.
Age: 74.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Expired drug administered, No adverse event
Clinical narrative: Initial report received from a health care professional (nurse) on 25 May 2010: This patient was vaccinated with expired S-OIV FLUVIRIN (batch no: 102136P1A), (dose: 0.5 ml) intramuscularly on 24 May 2010. No adverse reaction had occurred.
Age: 1.03
Sex: F
Vaccine: FLU(H1N1)
Symptoms: No adverse event
Clinical narrative: Initial report was received from health care professional on 26 May 2010: This patient (Two years old) was vaccinated with H1N1 (batch number unknown) on 16 May 2010. The patient received first dose of the vaccine on 28 Oct 2009, and second dose on 01 Apr 2010. The reporter was not sure whether the first two doses of vaccine were Novartis product. The patient was under observation of the pediatrician. No adverse event was reported. The outcome of the event was not reported. Follow-up report received from a health care professional on 14 Jun 2010: The reporter stated that no adverse reaction were reported on 07 Jun 2010. No further information was provided.
Sex: U
Vaccine: FLU(H1N1)
Symptoms: Expired drug administered, No adverse event
Clinical narrative: Initial report received from a health care professional on 16 Jun 2010: This patient was vaccinated with expired S-OIV FLUVIRIN (batch number: 105051P1m), (with an expiration date of May 2010), (dose unknown) intramuscularly on an unspecified date in Jun 2010. No adverse reaction had occurred following this administration.
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Urticaria
Clinical narrative: Combine initial and follow up information report from physician received on 23 Jul 2010 and 26 Jul 2010: This patient was vaccinated with S-OIV FLUVIRIN (batch number. unknown), intramuscular, on an unspecified date. The patient was broke out in hives from an injection of S-OIV FLUVIRIN and previous to that broke out from eating gummy bear on an unspecified date. The outcome of event was not reported.
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Chills, Muscular weakness
Clinical narrative: Initial consumer report received on 13 Aug 2010: This patient received H1N1 (manufacturer unknown) unknown dose intramuscularly in fall 2009. As the manufacturer was unknown it was conservatively taken as Influenza virus vaccine pandemic INN. On an unknown date, 24 hours after receiving the vaccine, the patient experienced chills and generalized muscle weakness which lasted roughly 12 hours. The outcome of the event was reported as complete recovery. Follow-up report received from a consumer on 30 Aug 2010:The reporter stated that she was not shot (vaccinated) at pharmacy and did not see her nurse after the reaction. After 18 hrs of vaccination, the patient was doing better and by second day she was back to normal. The patient's husband reported about the reaction.
Age: 6.0
Sex: U
Vaccine: FLU(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Initial report received from a health care professional on 20 Aug 2010: This child was vaccinated with H1N1 vaccine (manufacturer and batch number unknown), on an unspecified date. The reporter stated that the child only received the dose of H1N1 vaccine last reason. The reporter also stated that child was vaccinated with 2 doses of seasonal flu vaccine last year (date unspecified), spaced apart by one month. The outcome of the event was not reported. Follow up report received from the health care professional on 26 Aug 2010: The child was vaccinated with S-OIV FLUVIRIN (batch number not reported). No adverse events were reported in this child.
Age: 62.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Expired drug administered
Clinical narrative: Initial pharmacist report received on 20 Aug 2010: This patient received Novartis H1N1 vaccine (batch number 102149P1, expiration date 30 Apr 2010) 0.5 ml dose intramuscularly on an unknown date. The suspect product was taken as S-OIV FLUVIRIN conservatively. It was reported that the vaccine (Novartis H1N1) was expired when it was given to the patient. No other information was reported. Follow up report received from the health care professional on 14 Sep 2010: The patient was vaccinated with S-OIV FLUVIRIN, 0.5 ml intramuscularly in the left deltoid on 16 Aug 2010.
Age: 55.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Expired drug administered
Clinical narrative: Initial report received from a health care professional (pharmacist) on 20 Aug 2010: On an unspecified date this patient received a 0.5 ml intramuscular dose of expired S-OIV FLUVIRIN (batch number 102149P1) that had an expiration date of 30 Apr 2010. No further information provided at the time of this report. Follow up report received from the health care professional on 14 Sep 2010: The patient was vaccinated with S-OIV FLUVIRIN, 0.5 ml intramuscularly in the left deltoid on 16 Aug 2010.
Age: 44.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Expired drug administered
Clinical narrative: Initial report received from a health care professional (pharmacist) on 20 Aug 2010: On an unspecified date this patient received a 0.5 ml intramuscular dose of expired S-OIV FLUVIRIN (batch number 102149P1) that had an expiration date of 30 Apr 2010. No further information provided at the time of this report. Follow up report received from the health care professional on 14 Sep 2010: The patient was vaccinated with S-OIV FLUVIRIN, 0.5 ml intramuscular in the left deltoid on 19 Aug 2010.
Age: 15.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Initial report received from the Health care professional on 19 Mar 2010: This patient was vaccinated with two separate dose of S-OIV FLUVIRIN (batch number 102134P1A) 0.5 ml intramuscularly on aN 18 Mar 2010. According to the reporter, it was happened due to the nurse thought that one of the dose was of IPV. The patient did not experienced any other adverse event. The outcome of the event was not reported and no further information was provided at the time of report.
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Feeling jittery
Clinical narrative: Initial healthcare professional report received on 25 Mar 2010: This patient vaccinated with S-OIV FLUVIRIN (batch 10073803), IM, on 29 Oct 2009. The patient experienced being on-edge or jittery for about 4-5 days on an unspecified date. The outcome of event was not reported.
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Insomnia
Clinical narrative: Initial healthcare professional report received on 25 Mar 2010: This patient vaccinated with S-OIV FLUVIRIN (batch 10073803), intramuscular, on 29 Oct 2009. On an unknown date (for several days after vaccination), this patient could not sleep. The outcome of event was not reported.
Age: 1.3
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Initial consumer (patient's mother) received on 29 Mar 2010: This patient received S-OIV FLUVIRIN (batch no. unknown) unknown dose intramuscular on an unknown date in 2009. It was reported that 15 months old patient received Novartis H1N1 vaccine on an unknown date in 2009. No other information was provided. The outcome of the event was not reported.
Age: 3.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Initial report received from a health care professional on 29 Mar 2010: This patient under (04 years of age) received S-OIV FLUVIRIN (batch no: 1013284P), intramuscular, on 23 Mar 2010. The outcome of the event was not reported.
Age: 12.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Initial report received from a healthcare professional on 31 Mar 2010: This patient was vaccinated with two doses S-OIV FLUVIRIN (batch number: 102045P1), intramuscular, on 31 Mar 2010. On 31 Mar 2010 (on same day), the patient inadvertently received two doses of FLUVIRIN vaccine. No adverse reaction occurred. The outcome of the event was not reported. Follow up report received from a healthcare professional on 10 Jun 2010: It was reported that the patient did not experience any adverse events and the patient is doing fine. No other information was reported.
Sex: U
Vaccine: FLU(H1N1)
Symptoms: Expired drug administered, No adverse event
Clinical narrative: Initial report received from a physician on 05 Apr 2010: This patient was vaccinated with FLUVIRIN (unknown batch no), (dose unspecified), on 01 Apr 2010. The patient was administered with expired vaccine and no adverse reaction occurred. The reporter stated that she "does not want to get into that" and was unable to provide any identifying information about the patient or the vaccine lot number.
Age: 87.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Expired drug administered, No adverse event
Clinical narrative: Initial report received from health care professional on 05 Apr 2010: This patient with an unknown medical history received a dose of expired influenza virus vaccine (batch no. 1013284P, expiry date: Mar 2010) on 05 Apr 2010. It was reported that no adverse reaction occurred. The outcome was not reported.
Age: 61.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Expired drug administered, No adverse event
Clinical narrative: Initial report received from the nurse on 05 Apr 2010: This patient was inadvertently vaccinated with expired FLUVIRIN (batch no: 1013284P, exp date: Mar2010), 0.5 ml, intramuscular on 05 Apr 2010. On 05 Apr 2010, this patient had not presented with adverse event. The outcome of the event was reported as unknown.
Age: 28.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Expired drug administered
Clinical narrative: Initial report received from healthcare professional on 06 Apr 2010: This patient received expired FLUVIRIN (batch no: 101328, exp. date: 31 Mar 2010), 0.5 ml intramuscular on 06 Apr 2010. No adverse event was noted after administration. Follow up report received from a physician on 18 May 2010: Patient demographics were added. The reporter stated that the patient received expired FLUVIRIN (batch no: 1013286P) 6 days after expiry date. No further information was provided.
Age: 44.0
Sex: M
Vaccine: FLU(H1N1), JEV1, TTOX, TYP
Symptoms: Pyrexia
Clinical narrative: Initial report received from nurse on 07 Apr 2010: This patient was vaccinated with S-OIV FLUVIRIN, (batch no: unknown), on 08 Mar 2010. On 08 Mar 2010, this patient was also vaccinated with IXIARO (manufacture unknown), (batch no: JEV08E108), 0.5 ml intramuscular and with Tetanus vaccine, (manufacture unknown, therefore considered conservatively as INN) and with TYPHORAL, (manufacture unknown) for unspecified indication. On 09 Mar 2010, this patient had presented with fever for a 24 hour period. The outcome of the event was reported as completely recovered on 10 Mar 2010. On 05 Apr 2010, this patient was second time vaccinated with IXIARO with no adverse event noted.
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Accidental exposure, No adverse event
Clinical narrative: Initial case report received from a nurse on 14 Apr 2010: This patient was inadvertently vaccinated with S-OIV FLUVIRIN (batch no. unknown) 0.5 ml intramuscularly on 13 Apr 2010. According to the reporter, no adverse events were noted after the vaccine administration. The outcome of the event was not reported.
Age: 6.0
Sex: U
Vaccine: FLU(H1N1)
Symptoms: Expired drug administered, No adverse event
Clinical narrative: Initial report received from medical assistant on 27 Apr 2010: This patient with an unknown medical history received expired FLUVIRIN (batch no 102046P1, expiry date- 31 Mar 2010) 0.5 ml, intramuscularly on 26 Apr 2010. The patient did not experienced any adverse event.
Age: 5.0
Sex: U
Vaccine: FLU(H1N1)
Symptoms: Expired drug administered, No adverse event
Clinical narrative: Initial report received from medical assistant on 27 Apr 2010: This child patient was inadvertently vaccinated with S-OIV FLUVIRIN, (batch no: 102046P1, exp date: 31 Mar 2010), 0.5 ml intramuscular on 26 Apr 2010. No adverse events were noted after vaccination.
Sex: U
Vaccine: FLU(H1N1)
Symptoms: Expired drug administered
Clinical narrative: Initial report received from a pharmacist on 08 Mar 2010: It was reported that, expired dose of Influenza virus vaccine (unknown batch no.) on an unknown date. It was also reported that the vaccine expired in Feb and was administered six days after the expiration date. The outcome of the event was reported as unknown.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: Initial report received from a health care professional on 08 Mar 2010: This patient was vaccinated with expired FLUVIRIN (batch no: 1012785), (dose: unknown) intramuscularly on 05 Mar 2010. No adverse reaction had occurred.
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Expired drug administered, No adverse event
Clinical narrative: Initial health care professional report received on 10 Mar 2010: This patient received expired FLUVIRIN 0.5 ml intramuscular on an unknown date in Mar 2010, sometime between 01 Mar 2010 and 09 Mar 2010. No other adverse events was reported.
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Expired drug administered, No adverse event
Clinical narrative: Initial health care professional report received on 10 Mar 2010: This patient received expired FLUVIRIN, 0.5ml intramuscular on an unknown date in Mar 2010, sometime between 01 Mar 2010 and 09 Mar 2010. None other adverse events was reported.
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Expired drug administered
Clinical narrative: Initial report received from a health care professional, office manager on 10 Mar 2010: This patient was vaccinated with expired dose of FLUVIRIN (Batch No. 10103265P), 0.5 ml, intramuscularly, QD, sometime between 01 Mar 2010 and 09 Mar 2010 (on an unspecified date). The outcome of the event was not reported.
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Expired drug administered, No adverse event
Clinical narrative: Initial health care professional report received on 10 Mar 2010: This patient received expired FLUVIRIN, 0.5ml intramuscular on an unknown date in Mar 2010, sometime between 01 Mar 2010 and 09 Mar 2010. No other adverse events was reported.
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Expired drug administered
Clinical narrative: Initial report received from a health care professional, office manager on 10 Mar 2010: This patient was vaccinated with expired dose of FLUVIRIN (Batch No. 1013265P), 0.5 ml, intramuscularly, sometime between 01 Mar 2010 and 09 Mar 2010 (on an unspecified date). The outcome of the events was not reported.
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Expired drug administered, No adverse event
Clinical narrative: Initial health care professional report received on 12 Mar 2010: This patient received expired FLUVIRIN (batch number 1009221P) unknown dose intramuscular, on an unspecified date. No other adverse event was reported.
Sex: U
Vaccine: FLU(H1N1)
Symptoms: No adverse event
Clinical narrative: Initial health care professional report received on 12 Mar 2010: This child received FLUVIRIN (batch number 102147P1) 0.25ml dose intramuscular inadvertently on an unspecified date. No other adverse event was reported.
Age: 24.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: Initial report received from healthcare professional on 16 Mar 2010: This patient was vaccinated with S-OIV FLUVIRIN, batch no: 102147P1, subcutaneously, on 16 Mar 2010. This patient inadvertently received a dose of Novartis H1N1 vaccine subcutaneously, on 16 Mar 2010. No other adverse reaction was occurred. The outcome of the event was not reported.
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Expired drug administered, No adverse event
Clinical narrative: Initial report received from a nurse on 17 Mar 2010: This patient was vaccinated with FLUVIRIN, intramuscular, ml, on an unspecified date. The patient was vaccinated with expired vaccine (date unspecified). The reporter stated she didn't knew of any adverse events. The outcome of the event, seriousness criteria and causality were not reported.
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Expired drug administered, No adverse event
Clinical narrative: Initial report received from a nurse on 17 Mar 2010: This patient was vaccinated with FLUVIRIN (batch no 1009231p), intramuscular, 0.5 ml, on an unspecified date. The patient was vaccinated with expired vaccine (date unspecified). The reporter stated she didn't know of any adverse events. The outcome of the event, seriousness criteria and causality were not reported.
Age: 5.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Expired drug administered, No adverse event
Clinical narrative: Initial report received from a nurse on 18 Mar 2010: This patient inadvertently administered FLUVIRIN (expiry date: Feb 2010) (Batch no.: 1009234P), intramuscular, expired vaccine on 18 Mar 2010. No adverse effects were reported after administration. The outcome of the event was not reported. Non-significant follow-up was received on 18 Mar 2010 with no new information provided.
Age: 5.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Expired drug administered, No adverse event
Clinical narrative: Initial report received from a nurse on 18 Mar 2010: This patient inadvertently administered FLUVIRIN (expiry date: Feb 2010) (Batch no.: 1009234P), intramuscular, expired vaccine on 18 Mar 2010. No adverse effects were reported after administration. The outcome of the event was not reported.
Age: 9.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Expired drug administered, No adverse event
Clinical narrative: Initial report received from a nurse on 18 Mar 2010: This patient inadvertently administered FLUVIRIN (expiry date: Feb 2010) (Batch no.:1009234P), intramuscular, expired vaccine on 18 Mar 2010. No adverse effects were reported after administration. The outcome of the event was not reported.
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 17 Feb 2010: This patient under the age of 4 years with unknown medical history was inadvertently received S-OIV FLUVIRIN (batch no. 102138P1A), 0.5 ml, IM, on 16 Feb 2010. No adverse effects were noted after vaccine administration.
Age: 3.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Initial report received from a nurse on 17 Feb 2010: This patient (a child under the age of 4 years) inadvertently received a 0.5 mL IM dose of S-OIV FLUVIRIN (batch no 102138P1A) on 16 Feb 2010. No adverse effects were noted after administration.
Age: 3.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Initial report received from a nurse on 17 Feb 2010: This patient (a child under the age of 4 years) inadvertently received a 0.5 mL IM dose of S-OIV FLUVIRIN (batch no 102138P1A) on 16 Feb 2010. No adverse effects were noted after administration.
Age: 3.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Initial report was received from the Nurse on 17 Feb 2010: This patient (under four years of age) was vaccinated with 0.5 ml of FLUVIRIN (batch number 102138P1A) intramuscularly on 16 Feb 2010. The outcome of patient's condition was not reported. The seriousness criteria of the patient was not reported.
Age: 1.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Initial report received from a HCP on 18 Feb 2010: This patient a 20 month old child inadvertently received a 0.5 mL IM dose of FLUVIRIN (batch no. 1009225P) on an unspecified date. No adverse effects were reported.
Age: 67.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Lip swelling, Rash
Clinical narrative: Initial report was received from a consumer on 22 Dec 2010: This patient was vaccinated with S-OIV FLUVIRIN (Novartis) (unknown batch no.) on 21 Nov 2009. On 01 Dec 2009 patient started to experienced rash on hands, thighs, legs, chest and feet. Patient reported that the rash disappears periodically since then but it had not completely gone away. Patient also had swollen lips since the onset of symptoms. It was reported that this symptoms had never appeared before receiving the vaccine. 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 HCP on 23 Feb 2010. This patient (a child of 3 years old) was inadvertently received a 0.5 mL IM dose of S-OIV FOCETRIA (batch no: 102041P1) on 23 Feb 2010. No adverse effects were reported after administration.
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Epistaxis, Eye pruritus, Lacrimation increased, Ocular hyperaemia
Clinical narrative: Initial report received from pharmacist on 23 Feb 2010: This patient received vaccination with FLUVIRIN batch no. 102125P1, unspecified dose intramuscular on an unknown date. On 21 Feb 2010 and 22 Feb 2010, the patient experienced nosebleed in the morning and red, itchy and watery eyes. The patient was also taking COUMADIN. The outcome of the events was not reported.
Age: 70.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Blister, Gastroenteritis viral, Hypoaesthesia, Rash erythematous, Rash pruritic
Clinical narrative: Initial report received from a consumer on 25 Feb 2010: This patient, with an unknown medical history was vaccinated with FLUVIRIN (batch no. unknown), 0.5 ml, intramuscularly on 21 Jan 2010. On 22 Jan 2010, the patient experienced abscessed tooth, numbness in hands, developed stomach flu and red, itchy rash over most of body that produced blisters. It was also reported that, about a week after the blisters began to appeared. The outcome of events stomach flu and abscessed tooth was reported as completely recovered and the outcome of events red, itchy rash, blisters and numbness in hands was reported as condition unchanged.
Age: 70.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Tooth abscess
Clinical narrative: Initial report received from a consumer on 25 Feb 2010: This patient, with an unknown medical history was vaccinated with FLUVIRIN (batch no. unknown), 0.5 ml, intramuscularly on 21 Jan 2010. On 22 Jan 2010, the patient experienced abscessed tooth, numbness in hands, developed stomach flu and red, itchy rash over most of body that produced blisters. It was also reported that, about a week after the blisters began to appeared. The outcome of events stomach flu and abscessed tooth was reported as completely recovered and the outcome of events red, itchy rash, blisters and numbness in hands was reported as condition unchanged.
Age: 2.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Follow-up report received from a HCP on 26 Feb 2010: This patient (2 year old) was inadvertently administered a dose of FLUVIRIN (batch no. 102125P1) on 26 Feb 2010. No adverse reaction had occurred. After an internal review done on 08 May 2010 to the information received on 26 Feb 2010, the following significant correction was made: The suspect product FLUVIRIN was recoded to S-OIV FLUVIRIN. It was also identified that the report received on 26 Feb 2010 was an initial report and not a follow-up report, as previously reported.
Age: 2.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Follow-up report received from a physician on 26 Feb 2010: This patient (2 year old) was inadvertently administered a second dose of FLUVIRIN (batch no. 102147P1) of the recommended 2 dose series on 24 Feb 2010. No adverse reaction had occurred. After an internal review done on 08 May 2010 to the information received on 26 Feb 2010, the following significant correction was made: The suspect product FLUVIRIN was recoded to S-OIV FLUVIRIN. It was identified that the report received on 26 Feb 2010 was an initial report and not a follow-up, as previously reported.
Age: 38.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Expired drug administered, No adverse event
Clinical narrative: Follow-up report received from a physician on 01 Mar 2010: This patient received a 0.5 mL IM dose of FLUVIRIN (batch no. 10073802) on 01 Mar 2010 that expired in Jan 2010. No adverse effects were noted due to administration of the vaccine. After an internal review done on 08 May 2010 to the information received on 01 Mar 2010, the following significant correction was made: The suspect product FLUVIRIN was recoded to S-OIV FLUVIRIN.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Inappropriate schedule of drug administration, Incorrect dose administered
Clinical narrative: Initial report received from a health care professional on 02 Mar 2010: This patient was inadvertently vaccinated with FLUVIRIN (Batch No. 105461P1), 0.5 ml, intramuscularly, on 01 Mar 2010 and secondly on 02 Mar 2010.
Age: 69.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Expired drug administered
Clinical narrative: Initial report received from a health care professional on 02 Mar 2010: This patient was inadvertently vaccinated with a expired dose of FLUVIRIN (Batch No. 10127806), intramuscularly, on 02 Mar 2010. The outcome of the event was not reported.
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Initial health care professional report received on 05 Mar 2010: This patient received FLUVIRIN (batch number 102145P1) unknown dose, intramuscular, on 01 Mar 2010. On 01 Mar 2010, the patient inadvertently received a dose of Novartis FLUVIRIN that was stored at temperatures above refrigeration. It was reported that the vaccine had reached 80F in temperature over the time period of a weekend. It was reported that no adverse reaction occurred and the patient was referred to MD. It was reported that death did not occur and no hospitalization due to the adverse event. The outcome of the event was not reported.
Age: 87.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Syringe issue
Clinical narrative: Initial report received from the health care professional on 27 Aug 2010: This patient was vaccinated with S-OIV FLUVIRIN (lot number 111799P1) intramuscularly, on 27 Aug 2010. On 27 Aug 2010, during administration, vaccine sprayed out of the needle onto the patient's arm and needle was fully inserted into the patients arm at the time. The outcome of event was not reported. Follow up healthcare professional report received on 06 Sep 2010: It was reported that the patient had medical history of allergy to penicillin and had diabetes. The patient was given 0.5 ml dose of vaccine intramuscularly into the deltoid.
Age: 86.0
Sex: M
Vaccine: FLU3
Symptoms: Inappropriate schedule of drug administration, Incorrect dose administered, No adverse event
Clinical narrative: Initial report received from a pharmacist on 14 Sep 2010: This patient was vaccinated with FLUVIRIN (batch number 111799P1), 0.5 ml intramuscularly, on 14 Sep 2010. The reporter stated that the patient received an influenza virus vaccine (unknown manufacturer) a week prior at another pharmacy. No adverse events were reported since administration.
Age: 64.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Injection site erythema, Injection site haemorrhage, Injection site swelling
Clinical narrative: Initial report received from a healthcare professional on 11 Dec 2009: This patient received FLUVIRIN, 0.5 ml, intramuscularly on 11 Dec 2009. Immediately after vaccination, the patient's injection site began to bleed and had swelling and redness at the injection site. It was reported that bleeding was subsided but swelling and redness were still present. The outcome of the events was reported as ongoing.
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Rash
Clinical narrative: Initial report was received from a health care professional on 10 Dec 2009: This patient received FLUVIRIN intramuscular in to deltoid on an unspecified date. It was reported that patient called her pharmacy that she developed rash on her face on an unknown date. The outcome of the event was not reported.
Age: 72.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: Initial report received from the consumer on 15 Dec 2009: This patient received FLUVIRIN on an unknown date and patient developed itchy red skin rash. The patient was also on EXFORGE for an unknown indication since unspecified date (since 3 weeks). The outcome of the event was reported as it was not known whether rash continued.
Age: 22.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Injection site mass, Injection site pain
Clinical narrative: Initial health care professional report received on 01 Dec 2009: The patient had received FLUVIRIN (batch no: 102042P1) intramuscularly on an unspecified date in Nov 2009. The patient complained of pain at injection site that began at day of injection and continued at the time of report. The patient also developed a knot it palpable at injection site in left deltoid. The outcome for event knot it palpable at injection site was not reported.
Age: 13.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Chills, Dizziness, Dyspnoea
Clinical narrative: Initial report from the health care professional received on 01 Dec 2009: This patient had received FLUVIRIN on 29 Nov 2009. The batch number was 102042P1A. On the morning of 01 Dec 2009, the patient had dizziness, chills and shortness of breath. At the time of the report, the events were ongoing. No further information received at the time of the report.
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Hypersensitivity
Clinical narrative: Initial report received from a consumer on 07 Dec 2009: This patient was received FLUVIRIN (batch no: 97840P1) on 17 Sep 2009. The patient had an allergic reaction after receiving flu shot on 17 Sep 2009. The outcome of the event was reported as recovered on 17 Sep 2009.
Age: 71.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Erythema
Clinical narrative: Initial physician report was received on 23 Dec 2009: This patient was vaccinated with FLUVIRIN, batch number 103136P1, intramuscular on an unknown date. On 19 Dec 2009, this patient experienced redness, developed above the elbow not below the injection site. The redness was treated with TYLENOL on an unknown date. The outcome of patient's condition was reported as disappeared. The seriousness criteria of the patient was not reported.
Age: 38.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Chills, Influenza like illness, Myalgia, Pyrexia
Clinical narrative: Initial report received from other health care professional on 23 Dec 2009: This patient was vaccinated with FLUVIRIN 0.5 ml, intramuscular, on 17 Dec 2009 in the morning. Later on in the same day, on 17 Dec 2009, patient experienced flu-like symptoms, including fever, chills, and muscle pain. Symptoms had not completely subsided to date. The outcome of events were reported as condition unchanged.
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Erythema, Oedema peripheral, Pain in extremity, Skin warm
Clinical narrative: Initial report received from an administrator on 23 Dec 2009: This patient was vaccinated with S-OIV FLUVIRIN 0.5 ml, intramuscular, on 17 Dec 2009. 12 hours after vaccination on 17 Dec 2009, the patient experienced pain in the arm, the entire arm also became red, swollen, and warm. The outcome of the events was reported as had not subsided.
Age: 48.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Erythema, Oedema peripheral, Pain in extremity, Skin warm
Clinical narrative: Initial report received from an administrator of health unit on 23 Dec 2009: This patient was received FLUVIRIN 0.5 mL on 17 Nov 2009. He had pain in the arm. The entire arm also became red, swollen and warm on 17 Dec 2009. The patient had not recovered.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Sensation of heaviness
Clinical narrative: Initial case report received from a pharmacist via MedCom on 20 OCT 2009. A 58-year-old female patient, was vaccinated with FLUVIRIN (batch no. 97841P1) i.m. into the deltoid on 24 SEP 2009. On 20 OCT 2009 the patient told the reporter that since her vaccination she had pain and soreness radiating from the injection site throughout her deltoid and biceps. In addition the patient complained of a "heaviness" in the arm into which FLUVIRIN was injected. How soon after vaccination the symptoms began was not known by the reporter. No medical treatment has been sought. Whether the patient self-treated her symptoms was not known by the pharmacist. The described symptoms were not recovered at the time of the report. Reference no. NA09-006649. This case was reported as MA2009-3173. Follow up report received from a pharmacist on 22 Feb 2010: The patient had called the pharmacy and reported that the pain in her arm had slightly improved, but it was still present. Follow up report received on 09 Apr 2010: The reporter had been tried to contact (twice), without any response so far. Thus no further information is expected and this case is considered closed.
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Case previously recorded as MA2009-3021. We received the following information via our legal contractor on 15 OCT 2009: A female patient was vaccinated with influenza vaccine (manufacturer or batch no. unknown) on 03 SEP 2009. She stated that her left upper arm hurt since she received the shot. The outcome of the symptom is unknown. Addendum: Despite requests on 04 OCT 2009 and 21 OCT 2009 we did not receive any further information. No change in assessment.
Age: 49.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Injection site reaction, Pallor
Clinical narrative: Case previously recorded as MA2009-3259. Received the following information from a consumer on the 23 Oct 2009. This 49-year-old male patient, was vaccinated with 0.5 ml, intramuscular S-OIV FLUVIRIN (batch number unknown) on 21 Oct 2009. The patient experienced injection site reaction (blanching at injection site) FLUVIRIN administration. Concomitant medication was not reported.