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Tinnitus from INFLUENZA (SEASONAL) (FLUARIX) 2010

Vaccine Manufacturer:GLAXOSMITHKLINE
Vaccine Code:FLU
Vaccine Type:INFLUENZA VIRUS VACCINE
Vaccine Name:INFLUENZA (SEASONAL) (FLUARIX)
Year Reported:2010
Symptom Reported:Tinnitus

INFLUENZA (SEASONAL) (FLUARIX) Side Effects Report #392178
INFLUENZA (SEASONAL) (FLUARIX) vaccine side effect was reported on 06/14/2010. Female patient, 57.0 years of age, was vaccinated with INFLUENZA (SEASONAL) (FLUARIX). Patient symptoms: Tinnitus, "This case was reported by a pharmacist and described the occurrence of exacerbation of tinnitus in a 57-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline). The subject's medical history included allergy to gentamycin, allergy to neomycin and tinnitus. Concurrent medications included KLONOPIN. On 15 November 2008 at 10:11, the subject received unspecified dose of FLUARIX (.5 ml, unknown, left arm). On 16 November 2008, 1 day after vaccination with FLUARIX, the subject experienced exacerbation of tinnitus. The pharmacist reported that the subject experienced a worsening in her tinnitus after received FLUARIX. FLUARIX was administered at the pharmacy on Saturday, and then on Sunday she noticed the worsening of her tinnitus. The time of day for the onset is unknown. The worsened tinnitus was bothersome to the subject but has not required medical treatment at this time. Of note, the subject has a history of an allergy to neomycin and gentamycin but she has had flu vaccines in the past and never had a problem, thus the decision was made to use FLUARIX even though it contains a small amount of gentamycin. At the time of reporting the event was unresolved. The pharmacist considered the event was possibly related to vaccination with FLUARIX." Unknown"Allergy to gentamycin; allergy to neomycin; tinnitus. The subject had previously received influenza vaccinations and ~no problems with flu vaccines in the past~. No adverse events were reported following receipt of prior immunizations."UNK . During the same period patient was treated with Clonazepam. Patient recovered.

INFLUENZA (SEASONAL) (FLUARIX) Side Effects Report #392199
INFLUENZA (SEASONAL) (FLUARIX) vaccine side effect was reported on 06/14/2010. Female patient, 63.0 years of age, was vaccinated with INFLUENZA (SEASONAL) (FLUARIX). Patient symptoms: Tinnitus, "This case was reported by a healthcare professional and described the occurrence of tinnitus-bilateral in a 63-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline). The subject had not previously received any flu shots. The subject's medical history included breast cancer. In 1975, the subject declined Td (tetanus and diphtheria vaccine) due to known reaction. ~PPD~ in August 2007 and was negative on 14 October 2008. Concurrent medications included FOSAMAX, PAXIL, FEMARA and XANAX. On 16 October 2008 the subject received 1st dose of FLUARIX (.5 ml, unknown, left arm). On 17 October 2008, 24 hours after vaccination with FLUARIX, the subject experienced tinnitus-bilateral. The physician's assistant reported that the subject developed the tinnitus greater in the left ear than the right ear and it was more annoying at night when things are quiet. At the time of reporting the events was unresolved. Follow-up information received on 13 February 2009 indicated that the event was still unresolved as of 27 January 2009. In the reporter's opinion, the event was possibly related to treatment with FLUARIX." Unknown"Breast cancer; The subject had not previously received any flu shots. In 1975, the subject declined Td (tetanus and diphtheria vaccine) due to known reaction. The subject was a non-smoker."PPD in August 2007 and on 14 October 2009 was negative. . During the same period patient was treated with Alendronate sodium; Paroxetine hydrochloride; Letrozole; Alprazolam. Patient recovered.


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