Age: 45.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Fatigue, Feeling abnormal, Oropharyngeal pain, Paraesthesia, Paraesthesia oral
Clinical narrative: This case was reported by a healthcare professional (also the subject) and described the occurrence of hand tingling in an adult female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of FLULAVAL (unknown). At an unspecified time after vaccination with FLULAVAL, the subject experienced tingling in the palm of the left hand, tingling of the arches of both feet, left side facial tingling, left side mouth (oral) tingling, sore throat and run down feeling. At the time of reporting the outcome of the events was unspecified. Follow-up information received on 04 January 2011 indicated that the subject was 45 years old. It was reported that events of oral tingling, sore throat and run down feeling were not experienced, but events of strange sensation in palm of left hand, strange feeling in sole of left foot and weird overall feeling were experienced. Onset of all symptoms was indicated to be 03 November 2010, which was the day of FLULAVAL vaccination. Events resolved by 05 November 2010. The reporter noted that when she received seasonal flu vaccine and H1N1 vaccine separated by several weeks in 2009, she experienced no problems. Follow-up information was received on 25 January 2011 via physician who reported the subject received intramuscular injection of FLULAVAL 0.5ml in the left deltoid. The physician reported that the subject "has never notified our office of any adverse events associated with her immunization". At the time of the report, no other information was provided. Follow-up information was received via the subject on 30 September 2011. The expiration date of the FLULAVAL vaccine administered was reported to be 30 June 2011. FLULAVAL was administered as reported previously on 03 November 2010. The time of injection was reported as 16:15. The subject reported all occurring symptoms to be what she considered an allergic reaction to FLULAVAL injection. The earliest events occurring as a part of this allergic reaction with an onset date and time of 03 November 2010, 17:08 (53 minutes following FLULAVAL administration) included abnormal sensation of left hand (ticking feeling palm of left hand), altered sensation of foot (tickling feeling in arch of left foot), tingling of extremities, tingling of face and overall malaise. These initial event episodes were reported to have resolved within three days (by 05 November 2010), however, there were reoccurrances of these events in later days following vaccination. Later, on either 10 or 17 November 2010 (earliest onset was 7 days following vaccination with FLULAVAL) the subject developed unusual migraine headaches (daily headaches that were different that her typical migraines). At this time the subject also experienced external ear pain. The subject reported experiencing two episodes of overwhelming exhaustion (debilitating exhaustion) with onset and outcome dates of 21 - 23 December 2010 and 03 - 07 January 2011. By mid January, 2 months following administration of FLULAVAL, the subject developed taste changes where she could not tolerate sweets for fresh fruit. These events were reported to be improving. On 01 February 2011, hand tingling was again reported (prickly feeling on the left side of the face) along with onset of localized tingling of ear (prickly feeling of left ear). At this time, a "metal-like" numbness of the left side of the face, external ear and lips was reported along with lightheadedness and nausea. On 08 February 2011, prickly feeling of both feet (more on left) was reported. Tingling feet had been reported previously. Also reported at this time were a tingling feeling in legs (prickly feeling on the legs) and lower extremity numbness from knee down (numbness in the left knee to the tips of the toes). Altered sensation of the foot also returned. On 04 March 2011, the subject developed a foggy feeling, left arm and leg weakness, walking difficulty (slightly labored walking especially in her left leg), toeing of leg (slight toeing of her left leg), standing and walking instability, decreased mobility of leg (a poorly functioning left leg), stiff tight knee (banding sensation in her left knee), continued malaise, the skin on her left arm and leg became very dry, body stiffness (a petrified sensation in her body) and a pulling sensation (a vacuum-like feeling on her face). In mid July 2011, the subject developed numbness and a prickly sensation on the tip of her tongue, upper back numbness (a paralyzing sensation on the left upper back), a crawling sensation and creepy feeling in the neck (a zipper sensation and crawling worms feeling on her neck). non-colored bumps on her left arm and back, possible facial drooping and abnormal gastric sounds (when drinking or when stomach gurgling, sounded like metal). The subject believed that it was possible that she experienced an allergic reaction to one of the components in FLULAVAL. She stated that approximately one third of her symptoms have improved. The subject reported visiting her physician's office due to symptoms. Concurrent medications reported included oral contraceptive, aspirin and Excedrin migraine. The subject noted that she experiences a reaction to the seasonal flu vaccine each year in which she develops pain at the injection site, a sore throat and run down feeling. She did not experience any reaction to the H1N1 vaccination which was administered separately last year, 2010. This case, A0896833A, is linked to duplicate case A0946085A. Very limited details were provided for duplicate case A0946085A and it was made VOID. This case, A0896833A, will remain as the active case.