Age: 69.0
Sex: F
Vaccine: FLUA3, VARZOS
Symptoms: Injection site urticaria, Insomnia, Malaise, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: swelling near eye and down arm; redness and swelling near eye and down arm; inability to get warm; reports waking up at 2 AM; hive noticed on ear and other unspecified places; Redness at the injection site; developing hives around injection site; staying in bed all day [fatigue]; fever in 101 range; Headache; unable to get muscles to relax and unclench; Chills; Sore arm; become sicker; This case was reported by a consumer via call center representative and described the occurrence of swelling in a 69-year-old female patient who received Herpes zoster (Shingrix) (batch number ZR979, expiry date unknown) for prophylaxis.   Co-suspect products included QUADRIVALENT INFLUENZA VACCINES (FLUAD QUADRIVALENT) for prophylaxis.   Previously administered products included Angioedema and Epipen (received on unknown date  Illness at Vaccination).   On 27th August 2020, the patient received the 1st dose of Shingrix and the 1st dose of FLUAD QUADRIVALENT (intramuscular) .5 ml. On 27th August 2020, less than a day after receiving Shingrix and an unknown time after receiving FLUAD QUADRIVALENT, the patient experienced chills, pain in arm and malaise. On 28th August 2020, the patient experienced fatigue, fever, headache and muscle stiffness. On 29th August 2020, the patient experienced injection site hives and injection site erythema. On an unknown date, the patient experienced swelling, erythema, feeling cold, insomnia and injection site urticaria. On an unknown date, the outcome of the swelling, erythema, injection site hives, pain in arm and injection site erythema were not recovered/not resolved and the outcome of the fatigue, fever, headache, muscle stiffness, chills, malaise, feeling cold, insomnia and injection site urticaria were unknown.   It was unknown if the reporter considered the swelling, erythema, injection site hives, fatigue, fever, headache, muscle stiffness, chills, pain in arm, malaise, feeling cold, insomnia, injection site urticaria and injection site erythema to be related to Shingrix.  Additional details were provided as follows: The patient receiving 1st dose Shingrix last in left arm and Fluad Quadravalent flu vaccine in right arm.  The reporter reported first having a sore arm from Shingrix vaccine, and later that evening began to become sicker, notably developing chills and inability to get warm although it was a hot day outside. During bedtime, The reporter reported waking up at 2 AM putting on quilts and unable to get muscles to relax and unclench. At 2:30 AM The reporter reported going to kitchen to take temperature and notes a fever in 101 range although normal basal temperature usually runs in 96-97 range. The reporter reported also developing a headache that would not get better for a couple of days. That day The reporter reported staying in bed all day (fatigue) except for one hour. Halfway into the following day, the patient reported finally getting up and starting to do light activities.  The reporter reported developing hives around injection site extending down arm. Later, hive noticed on ear and other unspecified places. The reporter stated due to history of developing angioedema as a delayed response, she took Zyrtec twice a day because once a day was not stopping the hives from spreading. She stated having an epipen since the age of 18 due to an unspecified condition.  The reporter reported Monday was her first attempt at having a normal day, and today redness and swelling near eye and down arm, but not anywhere else.  The reporter consent to follow up. This case has been linked with case US2020176983 reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020176983:same reporter