chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 2.0
Sex: U
Vaccine: FLU(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Case previously recorded as MA2009-4594. Initial case report received from a nurse on 17 NOV 2009. A patient 2-year-old was vaccinated off label use (administration to the child younger than 4 years) with FLUVIRIN 2009/2010 (batch no. unknown) i.m on unknown date in 2009. No adverse effect was reported. Reference no: NA09-008403
Age: 0.94
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Case previously recorded as MA2009-4550. Initial case report received from a nurse on 18 NOV 2009. A patient below 4-year-old was accidentally vaccinated with 0.5 mL of FLUVIRIN 2009/2010 intramuscular, (batch no. 102126P1A, expiration date 31 MAR 2010) on 17 NOV 2009. NO adverse events was reported. NA09-008426.
Age: 0.57
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Case previously recorded as MA2009-4551. Initial case report received from a nurse, on 18 NOV 2009. A 6 month-old female patient was vaccinated with 0.5 ml of FLUVIRIN 2009/2010 (batch no. 1021261P1A, expiration date 31 MAR 2010) i.m. on 17 NOV 2009, an off-label indication. No adverse event was reported. Reference no: NA09-008426
Age: 1.39
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Case previously recorded as MA2009-4552. Initial case report received from a nurse via agency, on 18 NOV 2009. A 72-week-old patient was accidentally vaccinated with 0.5 mL of FLUVIRIN 2009/2010 intramuscular (batch no. 102126P1A) on 17 NOV 2009. No adverse events was reported. Company assessment: Seriousness criterion: not serious. Causality: not applicable. Expectedness assessment according to foreign/local agency: No change in benefit-risk-ratio. No measures necessary. Agency reference no.: NA09-008426.
Age: 0.53
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Case previously recorded as MA2009-4553. Initial case report received from a nurse via agency, on 18 NOV 2009. A patient 06-months-old male was accidentally vaccinated with FLUVIRIN 2009/2010 (batch no. 102126P1A) 0.5mL i.m on 17 NOV 2009. No adverse effect was reported. Company assessment: Seriousness criterion: not serious. Causality: not applicable. Expectedness assessment according to foreign and local label: Off label use is unexpected after vaccination with FLUVIRIN 2009/2010. No change in benefit-risk-ratio. No measures necessary. Agency reference no.: NA09-008426.
Age: 1.1
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Case previously recorded as MA2009-4554.  Initial case report received from a nurse via agency on 18 NOV 2009.  A 57-week old male patient was accidentally vaccinated with 0.5 mL i.m. FLUVIRIN 2009/2010 (batch no. 102126P1A) on 17 NOV 2009.  It was an out off label use because the patient was younger than 4 years.  No adverse events were reported.  Off label use is unexpected after vaccination with FLUVIRIN 2009/2010.  No change in benefit-risk-ratio.  No measures are necessary.  Agency reference no.: NA09-008426.
Age: 0.88
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Case previously recorded as MA2009-4568. Case report received from an office manager via physician, via MedCom, on 12 NOV 2009. 11-month-old patient was vaccinated with 0.25 mL of S-OIV FLUVIRIN (batch no. 102045P1) i.m. into right thigh on 10 NOV 2009. No adverse effect was reported. MedCom reference no.:NA09-008038.
Age: 1.76
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Case previously recorded as MA2009-4569. Case report received from an office manager via physician, via MedCom, on 12 NOV 2009. 1-year-old female patient was vaccinated with 0.25 mL of S-OIV FLUVIRIN  (batch no. 102045P1) i.m. into right thigh in 10 NOV 2009. No adverse effect was reported. MedCom reference no.: NA09-008038.
Age: 0.94
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Case previously recorded as MA2009-4570. Case report received from an office manager via physician, via MedCom, on 12 NOV 2009. 11-month-old male patient was vaccinated with 0.25 mL of S-OIV FLUVIRIN (batch no. 102045P1) i.m. into right thigh on 10 NOV 2009. No adverse effect was reported. MedCom reference no.:NA09-008038.
Age: 3.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Case previously recorded as MA2009-4595. Received the following via Medical Communications (MedCom) from a healthcare professional on 18 NOV 2009: 3 year and 9 month old child was vaccinated with S-OIV FLUVIRIN (batch number 1013263P) on 18 NOV 2009. Administration of S-OIV FLUVIRIN to a child younger than 4 is not recommended/licensed. No adverse events have been reported. MedCom ref. no.: NA09-008487.
Age: 3.0
Sex: U
Vaccine: FLU(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Case previously recorded as MA2009-4573. Case report received from a physician via MedCom, on 17 NOV 2009. Patient 3-year-old or younger was vaccinated with S-OIV FLUVIRIN (batch no. unknown) i.m. on 13 NOV 2009. No adverse effect was reported. MedCom reference no.: NA09-008308.
Sex: U
Vaccine: FLU(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Case previously recorded as MA2009-4574. Case report received from a physician, via Novartis Medical Communication, on 17 NOV 2009. Patient (gender unknown) under 3 year-old was vaccinated with S-OIV FLUVIRIN (batch no. unknown) i.m., on 13 NOV 2009. No adverse event was reported. MedCom reference no.: NA09-008308.
Sex: U
Vaccine: FLU(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Case previously recorded as MA2009-4575. Case report received from a physician, via Novartis Medical Communication, on 17 NOV 2009. Patient (gender unknown) under 3-year old was vaccinated with S-OIV FLUVIRIN (batch no. unknown) i.m., on 13 NOV 2009. No adverse event was reported. MedCom reference no.: NA09-008308.
Sex: U
Vaccine: FLU(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Case previously recorded as MA2009-4576. Case report received from a physician, via Novartis Medical Communication, on 17 NOV 2009. Patient (gender unknown) under 3 year-old was vaccinated with S-OIV FLUVIRIN (batch no. unknown) i.m., on 13 NOV 2009. No adverse event was reported. MedCom reference no.: NA09-008308.
Age: 1.83
Sex: M
Vaccine: FLU3
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Case previously recorded as MA2009-4602. Case report received from a physician via MedCom, on 18 NOV 2009. 21 month-old male patient was vaccinated S-OIV FLUVIRIN (batch no. 102044P1 ) i.m. on 18 NOV 2009. It was an out of label use because the patient was younger than 4 years. No adverse events were reported. MedCom reference no.: NA09-008466.
Sex: U
Vaccine: FLU(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Case previously recorded as MA2009-4577. Case report received from a physician, via Novartis Medical Communication, on 17 NOV 2009. Patient (gender unknown) under 3 year-old was vaccinated with S-OIV FLUVIRIN (batch no. unknown) i.m., on 13 NOV 2009. No adverse event was reported. MedCom reference no.: NA09-008308.
Sex: U
Vaccine: FLU(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Case previously recorded as MA2009-4578. Case report received from a physician, via Novartis Medical Communication, on 17 NOV 2009. Patient (gender unknown) under 3 year-old was vaccinated with S-OIV FLUVIRIN (batch no. unknown) i.m., on 13 NOV 2009. No adverse event was reported. MedCom reference no.: NA09-008308.
Age: 3.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Case previously recorded as MA2009-4608. Case report received from a health care professional, via Novartis Medical Communication, on 18 NOV 2009. 3 year-old male patient was vaccinated with 0.5 ml of S-OIV FLUVIRIN (batch no. 1009224P) i.m. on 17 NOV 2009, an off-label indication. No adverse event was reported. MedCom reference no.: NA09-008431.
Sex: U
Vaccine: FLU(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Case previously recorded as MA2009-4579. Case report received from a physician, via Novartis Medical Communication, on 17 NOV 2009. Patient (gender unknown) under 3 year-old was vaccinated with S-OIV FLUVIRIN (batch no. unknown) i.m., on 13 NOV 2009. No adverse event was reported. MedCom reference no.: NA09-008308.
Age: 8.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Case previously recorded as MA2009-4611. Case report received from a nurse, on 18 NOV 2009. 8 year-old male patient was vaccinated with an overdose (double-dose, one dose in each thigh) of S-OIV FLUVIRIN (batch no. 102041P1) i.m. on 17 NOV 2009. No adverse event was reported. Reference no.: NA09-008419.
Age: 26.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Drug exposure during pregnancy, Incorrect dose administered, No adverse event
Clinical narrative: Case previously recorded as MA2009-4535. Case report received from a registered nurse, on 10 NOV 2009. 26-year-old female pregnant patient was vaccinated with and overdose of 1 mL of FLUVIRIN (batch no. 98468P1) i.m.. No adverse effect was reported. Reference no.:NA09-007809. Follow up report received on 26 Apr 2010: There was an twice attempt to contact reporter, but no response received so far. Therefore the case was closed with a consideration as a lost of follow up.
Age: 3.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Case previously recorded as MA2009-4630. Case report received from a nurse, on 17 NOV 2009. 3 year-old female patient was vaccinated with S-OIV FLUVIRIN (batch no. 1008142P) i.m. on 13 NOV 2009, an off-label use. No adverse event was reported. Reference no.: NA09-008410.
Age: 35.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Drug exposure during pregnancy, Incorrect dose administered, No adverse event
Clinical narrative: Case previously recorded as MA2009-4536. Case report received from a registered nurse, on 10 NOV 2009. 35-year-old female pregnant patient was vaccinated with an overdose of 1 mL FLUVIRIN (batch no. 98468P1) i.m.. No adverse effect was reported. Reference no.:NA09-007809. Follow up report received on 26 Apr 2010: There was an twice attempt to contact reporter, but no response received so far. Therefore the case was closed with a consideration as a lost to follow up.
Age: 3.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Case previously recorded as MA2009-4636. Initial case report received from a nurse via agency on 17 NOV 2009. A patient 3-year-old female was vaccinated with FLUVIRIN 2009/2010 (batch no. 1020401P1) i.m on unknown date in 2009. No adverse effect was reported. Company assessment: Seriousness criterion: not serious. Causality: not applicable. Expectedness assessment according to the foreign and local label: Off label use is unexpected after vaccination with FLURIVIN 2009/2010. No change in benefit-risk-ratio. No measures necessary. Agency reference no.: NA09-008367.
Sex: U
Vaccine: FLU(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Case previously recorded as MA2009-4638. Case report received from a health care professional, on 17 NOV 2009. Patient under 4 years was vaccinated i.m. with one dose of S-OIV FLUVIRIN (batch no. unknown)in 2009. It was an out of label use because the patient was younger than 4 years. No adverse events were reported. Reference no.: NA09-008366.
Age: 60.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Drug exposure during pregnancy, Incorrect dose administered, No adverse event
Clinical narrative: Case previously recorded as MA2009-4537. Initial case report received from a registered nurse via agency, on 10 NOV 2008. A 60-year-old female patient was vaccinated with an overdose of 1 mL of FLUVIRIN 2009/2010 (batch no. 98468P1) i.m. No adverse effect was reported. Company assessment: Seriousness criterion: not serious. Causality: not applicable. Expectedness assessment according to foreign and local label: Pregnancy is expected and overdose is unexpected regarding vaccination with FLUVIRIN 2009/2010. No change in benefit-risk-ratio. No measures necessary. Agency reference no.: NA09-007809. Follow up report received on 26 Apr 2010: There was an twice attempt to contact reporter, but no response received so far. Therefore the case was closed with a consideration as a lost to follow up.
Sex: U
Vaccine: FLU(H1N1)
Symptoms: Unevaluable event
Clinical narrative: Case previously recorded as MA2009-4788. Report received on 23 NOV 2009 via agency from a healthcare professional the following information: Several children (details unknown) under the age of 4 were vaccinated i.m. with 0.5 ml FLUVIRIN, batch no. 102041P1 and 102044P1 on 20 NOV 2009. No adverse events were reported, no further information available. Company assessment: No serious criterion given. Causality: not applicable. Expectedness assessment according to foreign and local label: Vaccination with FLUVIRIN for children under 4 year is unexpected. No change in benefit-risk-ratio. No measures necessary. Agency no: NA09-008691.
Age: 0.73
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Case previously recorded as MA2009-4538. Initial case report received from a nurse via agency, on 18 NOV 2009. A patient 9-months-old male was accidentally vaccinated with FLUVIRIN 2009/2010 (batch no. 102126P1A) 0.5mL i.m on 17 NOV 2009. No adverse effect was reported. Company assessment: Seriousness criterion: not serious. Causality: not applicable. Expectedness assessment according to foreign and local label: Off label use is unexpected after vaccination with FLUVIRIN 2009/2010. No change in benefit-risk-ratio. No measures necessary. Agency reference no.: NA09-008426.
Age: 4.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Case previously recorded as MA2009-4792. Report received on 23 NOV 2009 via agency, from a healthcare professional the following information: A 4-year-old male patient was vaccinated i.m. only with 0.25 ml FLUVIRIN, batch no. unknown on 20 NOV 2009. No adverse event was reported. No further information available. Company assessment: No serious criterion given. Causality: not applicable. Expectedness assessment according to foreign agency: Given 0.25 ml FLUVIRIN is unexpected. No change in benefit-risk-ratio. No measures necessary. Agency no: NA09-008705.
Age: 1.62
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Case previously recorded as MA2009-4539. Case report received from a nurse, on 18 NOV 2009. 19 months-old male patient was accidentally vaccinated with 0.5 mL i.m. S-OIV FLUVIRIN (batch no. 102126P1A) on 17 NOV 2009. It was an out of label use because the patient was younger than 4 years. No adverse events were reported. Reference no.: NA09-008426.
Age: 0.54
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Case previously recorded as MA2009-4540. Case report received from a registered nurse, on 18 NOV 2009. 6-month-old male patient was accidentally vaccinated with  S-OIV FLUVIRIN (batch no. 102126P1A) i.m. on 17 NOV 2009. No adverse effect was reported. Reference no.:NA09-008426.
Age: 0.69
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Case previously recorded as MA2009-4541.  Initial case report received from a nurse via agency on 18 NOV 2009.  An 8 month-old male patient was vaccinated with 0.5 ml of FLUVIRIN 2009/2010 (batch no. 1021261P1A) i.m. on 17 NOV 2009, an off-label indication.  No adverse event was reported.  Off-label use is unexpected for S-OIV FLUVIRIN (2009/2010).  No change in benefit-risk-ratio.  No measures necessary.  Agency reference no.: NA09-008426.
Sex: U
Vaccine: FLU(H1N1)
Symptoms: Inappropriate schedule of drug administration, Incorrect storage of drug
Clinical narrative: Case previously recorded as MA2009-4797. Initial case report received from a pharmacist on 09 NOV 2009. Patient 6 month to 3 years were inadvertently vaccinated with FLUVIRIN 2009/2010 (batch no. unknown) 0.25 mL IM in 2009. When patients returned a month later, they received the remaining 0.25 mL dose IM from a saved syringe labeled with the patient's name. No adverse effect was reported. Seriousness criterion: not serious. Causality: no applicable. Off label use (child under 4 years old) and wrong storage (half-used syringe stored 1 month) are unexpected regarding vaccination with FLUVIRIN 2009/2010. On a case level, the case is considered unexpected. No change in benefit-risk-ratio. No measures necessary. Reference no.: NA09-007832.
Age: 2.0
Sex: M
Vaccine: FLUX(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Case previously recorded as MA2009-4542. Case report received from a nurse, on 18 NOV 2009. 2-year-old male patient was accidentally vaccinated with 0.5 mL of S-OIV FLUVIRIN intramuscular (batch no. 102126P1A, expiration date 31 MAR 2010) on 17 NOV 2009. No adverse events was reported. Reference no.: NA09-008426.
Age: 2.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Case previously recorded as MA2009-4543. Case report received from a nurse, on 18 NOV 2009. Patient 2-years-old female was accidentally vaccinated with  S-OIV FLUVIRIN (batch no. 102126P1A) 0.5mL i.m. on 17 NOV 2009. No adverse effect was reported. Reference no.:NA09-008426.
Age: 2.0
Sex: M
Vaccine: FLU3
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Case previously recorded as MA2009-4799. Case report received from a nurse, via Novartis, on 18 NOV 2009. 2 year-old male patient was vaccinated with 0.5 ml of S-OIV FLUVIRIN (batch no. 102126P1A, FEB 2010) i.m. on 15 NOV 2009, an off-label indication. No adverse event was reported. Reference no.: NA09-008489.
Age: 1.37
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Case previously recorded as MA2009-4544. Case report received from a nurse, on 18 NOV 2009. 16-month-old female patient was vaccinated accidentally with 0.5 mL i.m. S-OIV FLUVIRIN (batch no. 102126P1A) on 17 NOV 2009. It was an out of label use because the patient was younger 4 years. No adverse event was reported. Reference no.: NA09-008426.
Age: 2.0
Sex: F
Vaccine: FLU3
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Case previously recorded as MA2009-4800. Initial case report received from a nurse, on 18 NOV 2009. A 2-year-old female patient was vaccinated with 0.5 ml of FLUVIRIN (batch no. 1021261P1A, expiration date FEB 2010) i.m. on 15 NOV 2009, an off-label indication. No adverse event was reported. Reference no: NA09-008489.
Age: 1.66
Sex: M
Vaccine: FLU3
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Case previously recorded as MA2009-4545. Initial case report received from a nurse, on 18 NOV 2009. A patient 1-years-old male was accidentally vaccinated with FLUVIRIN 2009/2010 (batch no. 102126P1A) 0.5mL i.m on 17 NOV 2009. No adverse effect was reported. Reference no: NA09-008426.
Age: 0.37
Sex: F
Vaccine: FLU3
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Case previously recorded as MA2009-4546. Initial case report received from a nurse, on 18 NOV 2009. A 4 month-old female patient was vaccinated with 0.5 ml of FLUVIRIN 2009/2010 (batch no. 1021261P1A) i.m. on 17 NOV 2009, an off-label indication. No adverse event was reported. Reference no: NA09-008426.
Age: 3.0
Sex: F
Vaccine: FLU3
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Case previously recorded as MA2009-4547. Initial case received from a nurse, on 18 NOV 2009. A 3-year-old patient was accidentally vaccinated with 0.5 mL of FLUVIRIN 2009/2010 intramuscular (batch no. 102126P1A, expiration date 31 MAR 2010) on 17 NOV 2009. No adverse events was reported. Reference no: NA09-008426.
Age: 0.82
Sex: M
Vaccine: FLU3
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Case previously recorded as MA2009-4548. Initial case received from a nurse, on 18 NOV 2009. A 10-months-old male was accidentally vaccinated with FLUVIRIN 2009/2010 (batch no. 102126P1A) 0.5mL i.m on 17 NOV 2009. No adverse effect was reported. NA09-008426.
Age: 1.03
Sex: M
Vaccine: FLU3
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Case previously recorded as MA2009-4549. Initial case report received from a nurse, on 18 NOV 2009. A 53 week-old male patient was accidentally vaccinated with 0.5mL i.m. FLUVIRIN (batch no. 102126P1A) on 17 NOV 2009. It was an out of label use because the patient was younger than 4 years. No adverse events were reported. NA09-008426.
Age: 5.0
Sex: M
Vaccine: FLUX(H1N1)
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Initial report received from healthcare professional on 28 Jan 2010: This patients was vaccinated with FLUVIRIN (batch no. unknown), IM on 28 Jan 2010 and while the dose was being administered moved which resulted in spilled vaccine. The reporter has reported no adverse reaction occurred.
Age: 58.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Abdominal pain upper, Chills, Diarrhoea, Dizziness, Feeling abnormal
Clinical narrative: Report received from a consumer on 14-Dec-2009. A 58 year-old female patient received H1N1 vaccine, lot 00349611A on 03-Dec-2009 by intramuscular injection to the deltoid. The patient reported she was not ill at the time of vaccination, she was not pregnant at the time of vaccination, and she did not have any other vaccinations within the past 4 weeks. On 08-Dec-2009 at 9:00AM, 5 days post-vaccination, the patient developed nausea, diarrhea, stomach ache, chills, and dizziness. Patient described her symptoms as feeling like she had a stomach virus. The patient took ALKA SELTZER. The patient recovered on 12-Dec-2009. Patient did not notify her physician. No further information is expected. The company considered adverse events reported possible to PANVAX. The time to onset was delayed at 5 days and it is unknown if the patient was taking concomitant medication. Information derived from this report does not change the current safety profile of the product. Batch review request received for 00349611A on 29-Dec-2009. On completion of this investigation, it has been determined that all deviations related to the manufacture of this lot were asessed as having no impact on product quality. All QC testing was satisfactory with no out of specification results reported. There are no outstaning issues related to this lot that would potentially affect product quality. In conclusion, there has been no assignable cause drawn from this investigation that would indicate any association with the adverse event reported.
Age: 58.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Nausea
Clinical narrative: Report received from a consumer on 14-Dec-2009. A 58 year-old female patient received H1N1 vaccine, lot 00349611A on 03-Dec-2009 by intramuscular injection to the deltoid. The patient reported she was not ill at the time of vaccination, she was not pregnant at the time of vaccination, and she did not have any other vaccinations within the past 4 weeks. On 08-Dec-2009 at 9:00AM, 5 days post-vaccination, the patient developed nausea, diarrhea, stomach ache, chills, and dizziness. Patient described her symptoms as feeling like she had a stomach virus. The patient took ALKA SELTZER. The patient recovered on 12-Dec-2009. Patient did not notify her physician. No further information is expected. The company considered adverse events reported possible to PANVAX. The time to onset was delayed at 5 days and it is unknown if the patient was taking concomitant medication. Information derived from this report does not change the current safety profile of the product. Batch review request received for 00349611A on 29-Dec-2009. On completion of this investigation, it has been determined that all deviations related to the manufacture of this lot were asessed as having no impact on product quality. All QC testing was satisfactory with no out of specification results reported. There are no outstaning issues related to this lot that would potentially affect product quality. In conclusion, there has been no assignable cause drawn from this investigation that would indicate any association with the adverse event reported.
Age: 27.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Deafness, Dizziness, Hypoacusis, Pallor, Speech disorder
Clinical narrative: Report received from a consumer on 14-Dec-2009.  An adult female patient received H1N1 vaccine, lot number 00349611A by intra-muscular injection for immunization on 03-Dec-2009.  On 05-Dec-2009, 2 days post-vaccination, the patient felt like she was going to pass out, hearing was muffled, she was pale and experienced tunnel vision.  The patient reports she recovered on the same day (05-Dec-2009).  The company considers events possible to PANVAX administration, however, pending follow-up information.  Information derived from this AE report does not change the current safety profile of the product.  Follow-up information received 21-Dec-2009.  Patient provided age as 27 years.  Concomitant medication: Levonorgestrel and Ethinyl Estradiol for birth control.  On 05-DEC-2009 at approximately 10:00 AM, the patient (also reporter) developed tunnel vision, hearing loss and could not speak.  The events lasted approximately 5 minutes.  The patient outcome is recovered.  The patient did not notify her PCP (primary care physician).  No further information is expected.  Batch review request received for 00349611A on 29-DEC-2009.  On completion of this investigation, it has been determined that all deviations related to the manufacture of this lot were assessed as having no impact on product quality.  All QC testing was satisfactory with no out of specification results reported.  There are no outstanding issues related to this lot that would potentially affect product quality.  In conclusion, there has been no assignable cause drawn from this investigation that would indicate any association with the adverse event reported.
Age: 27.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Tunnel vision
Clinical narrative: Report received from a consumer on 14-Dec-2009.  An adult female patient received H1N1 vaccine, lot number 00349611A by intra-muscular injection for immunization on 03-Dec-2009.  On 05-Dec-2009, 2 days post-vaccination, the patient felt like she was going to pass out, hearing was muffled, she was pale and experienced tunnel vision.  The patient reports she recovered on the same day (05-Dec-2009).  The company considers events possible to PANVAX administration, however, pending follow-up information.  Information derived from this AE report does not change the current safety profile of the product.  Follow-up information received 21-Dec-2009.  Patient provided age as 27 years.  Concomitant medication: Levonorgestrel and Ethinyl Estradiol for birth control.  On 05-DEC-2009 at approximately 10:00 AM, the patient (also reporter) developed tunnel vision, hearing loss and could not speak.  The events lasted approximately 5 minutes.  The patient outcome is recovered.  The patient did not notify her PCP (primary care physician).  No further information is expected.  Batch review request received for 00349611A on 29-DEC-2009.  On completion of this investigation, it has been determined that all deviations related to the manufacture of this lot were assessed as having no impact on product quality.  All QC testing was satisfactory with no out of specification results reported.  There are no outstanding issues related to this lot that would potentially affect product quality.  In conclusion, there has been no assignable cause drawn from this investigation that would indicate any association with the adverse event reported.
Age: 34.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Chest discomfort, Dyspnoea, Headache, Lethargy, Malaise
Clinical narrative: Report received from a nurse on 21-Dec-2009.  A 34 year-old female patient received H1N1 vaccination (lot 00349611A) via intra-muscular injection into the left deltoid on 13-Nov-2009 (pm).  The patient has a medical history of asthma.  At the time of vaccination, patient had no illnesses.  Concomitant medications are unknown.  On 13-Nov-2009, the day of H1N1 vaccination, the patient developed a headache.  On 14-Nov-2009, the patient reported feeling lethargic without a headache.  On 15-Nov-2009, the patient reported feeling unwell, had increased lethargy, was congested, and had an irritated throat.  On 16-Nov-2009, the patient awoke with dyspnoea and chest heaviness.  The employee went to her physician and received breathing treatments, steroid pack, Ceftriaxone injection and was diagnosed with a right ear infection.  The patient outcome is not yet recovered.  Awaiting further information.  Information derived from this AE report does not change the current safety profile of the product.  Batch review request received for 00349611A on 29-DEC-2009.  On completion of this investigation, it has been determined that all deviations related to the manufacture of this lot were assessed as having no impact on product quality.  All QC testing was satisfactory with no out of specification results reported.  There are no outstanding issues related to this lot that would potentially affect product quality.  In conclusion, there has been no assignable cause drawn from this investigation that would indicate any association with the adverse event reported.  Follow-up information received on 28-DEC-2009.  The patient was not pregnant and outcome is completely recovered.
Age: 34.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Respiratory tract congestion, Throat irritation
Clinical narrative: Report received from a nurse on 21-Dec-2009.  A 34 year-old female patient received H1N1 vaccination (lot 00349611A) via intra-muscular injection into the left deltoid on 13-Nov-2009 (pm).  The patient has a medical history of asthma.  At the time of vaccination, patient had no illnesses.  Concomitant medications are unknown.  On 13-Nov-2009, the day of H1N1 vaccination, the patient developed a headache.  On 14-Nov-2009, the patient reported feeling lethargic without a headache.  On 15-Nov-2009, the patient reported feeling unwell, had increased lethargy, was congested, and had an irritated throat.  On 16-Nov-2009, the patient awoke with dyspnoea and chest heaviness.  The employee went to her physician and received breathing treatments, steroid pack, Ceftriaxone injection and was diagnosed with a right ear infection.  The patient outcome is not yet recovered.  Awaiting further information.  Information derived from this AE report does not change the current safety profile of the product.  Batch review request received for 00349611A on 29-DEC-2009.  On completion of this investigation, it has been determined that all deviations related to the manufacture of this lot were assessed as having no impact on product quality.  All QC testing was satisfactory with no out of specification results reported.  There are no outstanding issues related to this lot that would potentially affect product quality.  In conclusion, there has been no assignable cause drawn from this investigation that would indicate any association with the adverse event reported.  Follow-up information received on 28-DEC-2009.  The patient was not pregnant and outcome is completely recovered.
Age: 5.0
Sex: M
Vaccine: FLUX, FLUX(H1N1)
Symptoms: Cough, Wheezing
Clinical narrative: Report received by the mother of the patient on 03-Nov-2009.  The patient, a 5-year old male received seasonal flu shot 5 months ago (??-Jun-2009) and developed cough and wheezing that same day.  The symptoms lasted for about 1 week.  The patient received H1N1 vaccine and experienced similar symptoms the same day which lasted about one week.  The patient had also been on concomitant Vivaglobin for 5 months.  The mother stated the MD is not aware of these reactions.  Upon follow-up conversation with the mother (10-Dec-2009): Her son was vaccinated at the pediatrician's office and she provided the contact information.  She confirmed her son received vaccination for both the seasonal flu and two doses of H1N1 at this office.  The mother stated the purpose of her original call was not to report AEs to the vaccinations, but to request information about contraindications for vaccination since her son is on Vivaglobin.  We do not know if these were CSL products, and are awaiting information from the pediatrician's office.  Reference case 2009021793 (seasonal flu).  The company assessed the event causality as unassessable in relation to the suspect drug, H1N1 vaccine, as time to onset and date of administration were not known.  Information derived from this AE report does not change the safety profile of the product.
Age: 5.0
Sex: M
Vaccine: FLUX
Symptoms: Cough, Wheezing
Clinical narrative: Report received by the mother of the patient on 03-Nov-2009. The patient, a 5-year old male received seasonal flu shot 5 months ago (??-Jun-2009) and developed cough and wheezing that same day. The symptoms lasted for about 1 week. The patient received H1N1 and experienced similar symptoms the same day which lasted about one week. The patient was also on concomitant VIVAGLOBIN for 5 months. The mother stated the MD is not aware of these reactions. Upon follow-up conversation with the mother (10-Dec-2009): Her son was vaccinated at the pediatrician's office and she provided the contact information. She confirmed her son received vaccination for both the seasonal flu and two doses of H1N1 at this office. The mother stated the purpose of her original call was not to report AEs to the vaccinations, but to request information about contraindications for vaccination since her son is on VIVAGLOBIN. We do not know if these were CSL products, and are awaiting information from the pediatrician's office. See related case 2009021784 (H1N1). The company assessed the event causality as unassessable in relation to the suspect drug, H1N1, as time to onset and date of administration were not known. Information derived from this AE report does not change the safety profile of the product.
Age: 3.0
Sex: U
Vaccine: FLU3
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: 38 months old inadvertently received 0.5 ml of FLUVIRIN. Initial report received from a health care professional on 28 Jan 2010: This patient (38 months old) was inadvertently administered with 0.5 ml of FLUVIRIN (batch number 987447P1) on 27 Jan 2010, intramuscularly. No adverse events were reported.
Age: 3.0
Sex: M
Vaccine: FLU(H1N1), HEPA
Symptoms: Regurgitation, Vomiting
Clinical narrative: Report received from a consumer on 13-Jan-2010. A 3.5 male patient received H1N1 vaccine (lot unknown) for immunization on 11-Jan-2010. The patient had a medical history as follows: Diagnosis of specific antibody IgG4 deficiency. The patient vomited, developed rapid blinking, head shaking and exhaustion, difficulty walking, disorientation and decreased appetite on 9-JAN-2010 after Vivaglobin use. Past IVIG use over 8 hours in 2007 and over 6 hours in 2008 without adverse event; allergic reactions to many antibiotics (unspecified); mild autism; loss of appetite resulting in gastrostomy feeding tube placement in 2008; history of tumor in kidney requiring treatment with chemotherapy and radiation (2007); Right nephrectomy/tumor removal. Concomitant medications: Vivaglobin started on 9-JAN-2010 at 16 ml weekly in 3 sites over 1.5 hours for the treatment of specific antibody IgG4 deficiency, BACTRIM; ZANTAC; PERIACTIN; ZYRTEC; NASONEX; Hepatitis A vaccine on 11-Jan-2010. On 12-Jan-2010 the day after the administration of PANVAX, and after receiving formula feeding via a g-tube (gastrostomy feeding tube), the child 'threw up'. It appeared as though the stomach did not digest the food judging by the appearance of the regurgitated food. Treatment details and event outcome unknown. For Vivaglobin case, see case number 2010021878. Additional information has been requested. The company considered events to be possible in relation to the suspect drug. Information derived from this AE report does not change the current safety profile of the product.
Age: 3.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Case previously recorded as MA2009-4394.  Initial case report received from a nurse via agency on 16 NOV 2009.  A 3-year-old female patient was vaccinated with 0.5 mL of FLUVIRIN 2009/2010 (batch no. 102045P1) i.m., on 14 NOV 2009.  Administration to a child under 4-year-old is unexpected with S-OIV FLUVIRIN 2009/2010.  No change in benefit-risk-ratio.  No measures necessary.  Agency reference no.: NA09-008317.
Age: 3.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Case previously recorded as MA2009-4395.  Initial case report received from a nurse via agency on 16 NOV 2009.  A patient 3-year-old female was vaccinated with 0.5mL FLUVIRIN 2009/2010 (batch no. 102045P1) i.m. on 14 NOV 2009.  No adverse event was reported.  Wrong age (off label use) is unexpected after vaccination with S-OIV FLUVIRIN 2009/2010.  No change in benefit-risk-ratio.  No measures necessary.  Agency reference no.: NA09-008317.
Age: 3.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Case previously recorded as MA2009-4396.  Initial case report received from a nurse via agency on 16 NOV 2009.  A 3 year-old female patient was vaccinated with 0.5 mL of FLUVIRIN 2009/2010 (batch no. 102045P1) i.m. on 14 NOV 2009.  No adverse events were reported.  Wrong age is unexpected after vaccination with S-OIV FLUVIRIN 2009/2010.  No change in benefit-risk-ratio.  No measures are necessary.  Agency reference no.: NA09-008317.
Age: 3.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Case previously recorded as MA2009-4397.  Initial case report received from a registered nurse via agency on 16 NOV 2009.  A 3 year-old male patient was accidentally vaccinated with FLUVIRIN 2009/2010 (batch no. 100813) i.m. on 14 NOV 2009.  No adverse effect was reported.  Off label use (child under 4 years old) is unexpected regarding vaccination with S-OIV FLUVIRIN 2009/2010.  No change in benefit-risk-ratio.  No measures necessary.  Agency reference no.: NA09-008317.
Age: 3.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Case previously recorded as MA2009-4398.  Initial case report received from a nurse, via agency on 16 NOV 2009.  A 3 year-old male patient was vaccinated with 0.5 ml of FLUVIRIN 2009/2010 (batch no. 102045P1) i.m. on 14 NOV 2009, an off-label indication.  No adverse event was reported.  Vaccination in children younger than 4 year-old is an off-label use and unexpected for FLUVIRIN (2009/2010).  No change in benefit-risk-ratio.  No measures necessary.  Agency reference no.: NA09-008317.
Age: 3.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Wrong age.
Age: 3.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Case previously recorded as MA2009-4400.  Initial case report received from a nurse via agency on 16 NOV 2009.  A patient 3-year-old male was vaccinated with 0.5mL FLUVIRIN 2009/2010 (batch no. 102045P1) i.m. on 14 NOV 2009.  Wrong age is unexpected after vaccination with S-OIV FLUVIRIN 2009/2010.  No change in benefit-risk-ratio.  No measures necessary.  Agency reference no.: NA09-008317.
Age: 3.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Case previously recorded as MA2009-4401.  Initial case report received from a nurse via agency on 16 NOV 2009.  A 3 year-old female patient was vaccinated with 0.5 mL of FLUVIRIN 2009/2010 (batch no. 102045P1) i.m. on 14 NOV 2009.  No adverse events were reported.  Wrong age is unexpected after vaccination with FLUVIRIN 2009/2010.  No change in benefit-risk-ratio.  No measures are necessary.  Agency reference no.: NA09-008317.
Age: 3.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Case previously recorded as MA2009-4402.  Initial case report received from a registered nurse via agency on 16 NOV 2009.  A 3 year-old male patient was accidentally vaccinated with FLUVIRIN (batch no. 102045P1) i.m. on 14 NOV 2009.  Off label use (child under 4 years old) is unexpected regarding vaccination with FLUVIRIN 2009/2010.  No change in benefit-risk-ratio.  No measures necessary.  Agency reference no.: NA09-008317.
Age: 3.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Case previously recorded as MA2009-4403.  Initial case report received from a nurse, via agency on 16 NOV 2009.  A 3 year-old male patient was vaccinated with 0.5 ml of FLUVIRIN 2009/2010 (batch no. 102045P1) i.m. on 14 NOV 2009, an off-label indication.  No adverse event was reported.  Vaccination in children younger than 4 year-old is an off-label use and unexpected for FLUVIRIN (2009/2010).  No change in benefit-risk-ratio.  No measures necessary.  Agency reference no.: NA09-008317.
Age: 35.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Needle issue, Syringe issue, Underdose
Clinical narrative: Case previously recorded as MA2009-4428.  We received the following information via agency from a nurse on 16 NOV 2009:  A 35-year-old female patient was vaccinated i.m. with FLUVIRIN (batch number 102042P1A) on 16 NOV 2009.  During administration half the dose dripped from the needle and half the dose was wasted.  The dose was drawn from a multi dosage vial and the reporter stated that the needle and the syringe were not well connected.  Underdose of S-OIV FLUVIRIN is unexpected.  No change in benefit-risk-ratio.  No measures necessary.  Agency ref. no.: NA09-008257.
Age: 3.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Case previously recorded as MA2009-4497.  Initial case report received from a nurse, via agency on 20 NOV 2009.  A 3 year-old male patient was vaccinated with 0.5 ml of FLUVIRIN 2009/2010 (batch no. 101327) i.m., on 20 NOV 2009.  No adverse event was reported.  Administration to a child under 4 year-old is an off label use and unexpected for FLUVIRIN 2009/2010.  No change in benefit-risk-ratio.  No measures necessary.  Agency reference no.: NA09-008675.
Age: 3.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Case previously recorded as MA2009-4498.  Initial case report received from a nurse via agency on 20 NOV 2009.  A 3-year-old patient was vaccinated with 0.5 mL of FLUVIRIN 2009/2010 (batch no. 101327) i.m., on 20 NOV 2009.  Administration to a child under 4-year-old is unexpected with S-OIV FLUVIRIN 2009/2010.  No change in benefit-risk-ratio.  No measures necessary.  Agency reference no.: NA09-008675.
Sex: M
Vaccine: FLUX(H1N1)
Symptoms: Nasopharyngitis
Clinical narrative: Report received from Merck on 22-Feb-2010 (Merck Waes number 1002USA03065).  The reporter (reported as anonymous and the wife of the patient) reported that her husband receives different flu vaccines (manufacturers unspecified) every year and has received the H1N1 vaccine (manufacturer unspecified) and comes down with several colds each year.  No further information was received.  See related AFLURIA case 2010022121.  The company considers event causality as unassessable due to insufficient information.  Information derived from this AE report does not change the current safety profile of the product.
Age: 0.35
Sex: M
Vaccine: FLUX(H1N1)
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a nurse on 15-Jul-2010.  A 4 month old male received the H1N1 injection on 14-May-2010.  The nurse questioned when the infant could receive the second dose.  Patient outcome is unknown.  No further information was provided.  The company considered the event as unassessable to the suspect drug, H1N1 injection.  Information derived from this AE report does not change the current safety profile of the product.
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Drug exposure during pregnancy, Expired drug administered, No adverse event
Clinical narrative: Information has  been received from a agency on 22-JUL-2010.  On 30-Jun-2010, a pregnant female received 0.5 ml H1N1 with an expiration date of 30-Jun-2010.  There were no complaints of adverse events.  The agency reported that the pharmacy did not supply or administer the expired vaccine.  Information will be obtained from the nurse by the agency.  Additional information has been requested.  Information derived from this AE report does not change the current safety profile of the product.
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Drug exposure during pregnancy, Live birth
Clinical narrative: An adult female consumer called to report she was vaccinated with H1N1 somewhere between 21-Oct-2009 and 23-Oct-2009 (manufacturer specified as CSL but lot unknown).  The patient received the vaccine at a clinic (name unknown to reporter) when she was knowingly 4 months pregnant, after her pediatrician's office refused to vaccinate her.  The baby was born with no apparent issues, however she now has concerns that he moves his right arm rapidly which she does not notice with the left arm.  Based on recent publications regarding the safety of the seasonal flu vaccine, she is concerned about neurological damage to her baby (see associated case 2010026133).  Awaiting further information.  The company considers the event unassessable to the suspect drug, H1N1 vaccine.  Information derived from this AE report does not change the current safety of the profile.
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Movement disorder
Clinical narrative: An adult female consumer called to report she was vaccinated with H1N1 somewhere between 21-Oct-2009 and 23-Oct-2009 (manufacturer specified as CSL but lot unknown); see related case 2010025896.  The mother received the vaccine at a clinic (name unknown to reporter) when she was knowingly 4 months pregnant, after her pediatrician's office refused to vaccinate her.  The baby was born with no apparent issues, however she now has concerns that he moves his right arm rapidly which she does not notice with the left arm.  Based on recent publications regarding the safety of the seasonal flu vaccine, she is concerned about neurological damage to her baby.  Awaiting further information.  The company considers events unassessable to the suspect drug, H1N1 vaccine.  Information derived from this AE report does not change the current safety of the profile.
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Initial report was received from the Nurse on 29 Jan 2010: This patient (under four years of age) was vaccinated with 0.5 ml of H1N1, (batch number 102136P1) intramuscularly on an unknown date.  The outcome of patient's condition was reported as not available.  The seriousness criteria of the patient was not reported.