Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Laboratory test normal, Malaise, Nausea, Rash, Rash generalised
Clinical narrative: Case number PHEH2013US024367 is an initial spontaneous report received from a consumer on 18 Nov 2013: This report refers to a 71-year-old female patient. She was healthy before taking the flu shot and did not have any concomitant medications. Her medical history included allergies to Amozil diagnosed on 03 Jun 2009, allergy to Azithromycin diagnosed on 28 Nov 2011, and allergy to BACTRIM DS and Doxycycline. Her vaccination history included administration of influenza vaccine on 26 Sep 2009 (manufacturer and batch number: unknown) in the past that was tolerated well. She was also given pneumococcal vaccine, shingles vaccine and tetanus, diphtheria and pertussis vaccine (manufacturers and batch numbers: unknown), following which no adverse events were reported. She was vaccinated with FLUVIRIN (batch number: unknown) in to the left arm on 06 Sep 2013. For the following 16 to 20 days she was miserable. Within 24 hours after vaccination, she had an allergic reaction to the vaccine and visited many doctors and Emergency Room. The health care professionals stated that she had a very bad reaction to the flu shot. On 07 Sep 2013, she woke up with rash all over her body. She went back to the pharmacy where she was given the shot and was prescribed BENADRYL. On 08 Sep 2013, she still had rash and her body was warm, she visited the ER where she was told by the health care professional that she had infection and was given CLEOCIN to be taken thrice daily orally for 10 days. The infection was later on confirmed to be cellulitis and her vital signs (blood pressure, pulse rate, body temperature and respiratory rate) were recorded that were normal. On 09 Sep 2013, she got hives and went to the ER. She was diagnosed with mild to moderate allergic reaction and viral rash/exanthema and was told to make a follow-up visit if the condition got worsened. On 10 Sep 2013, she still had rash and her body was still hot, she was given a steroid injection and was sent home with prescription of unspecified steroids. She was diagnosed with contact dermatitis and allergic dermatitis secondary to the flu shot. She had rash and other non-specific skin eruptions. She was asked to follow-up with the physician in three to four days and was asked to continue taking BENADRYL 50 mg orally every six hours for six days and take prednisone 40 mg orally once a day for four days. On 12 Sep 2013, her condition remained unchanged; she was seen by a nurse who told that it was an allergic reaction to the flu shot. She was again given Clindamycin for the condition and was given another steroid injection. On 16 Sep 2013 and 17 Sep 2013 she had loose bowels and she still felt sick. On 17 Sep 2013 and 18 Sep 2013, she was feeling bad, cold and nauseous. She was seen by the nurse again and was told to eat toast and plenty of clear liquids and was prescribed Osco drugs. On 22 Sep 2013, her condition remained unchanged and she was diagnosed with dizziness and bradycardia. She was given additional medications; ZOFRAN 4mg tablet once every day for eight days orally for nausea and Meclizine one tablet thrice daily orally as needed for dizziness. Her vital signs were checked again and they were normal. Laboratory tests done included complete blood count (CBC), electrocardiogram and biochemical analysis of blood. Results for electrocardiogram was not reported, reports for CBC and biochemical analysis were normal. By end of Sep 2013, she felt better; however every now and then the symptoms came back but she would just try to sit down and relax until they would pass. No further information about seriousness and causality was reported.