Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypopnoea, Influenza like illness, Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: Pain in arm at injection site; Pain at different spots on upper right thigh; Shallow breathing; Body aches; Low grade fever; Shivering / Chills; sweating; upset stomach; feeling exhausted; Feeling faint and dizzy; Feeling faint and dizzy; rash at injection site on right arm; swelling at injection site on the right arm; Flu like symptoms; This case was reported by a consumer via call center representative and described the occurrence of faint in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   Concurrent medical conditions included multiple sclerosis. Concomitant products included hydrocodone bitartrate + paracetamol (Norco).   On 23rd November 2019, the patient received the 1st dose of Shingrix (intramuscular). On 21st November 2019, the patient received Influenza vaccine Quadrivalent unspecified season (intramuscular). In November 2019, less than a week after receiving Shingrix and Influenza vaccine Quadrivalent unspecified season, the patient experienced influenza-like symptoms, injection site rash and injection site swelling. On 23rd November 2019, the patient experienced faint (serious criteria GSK medically significant), injection site pain, pain in thigh, shallow breathing, general body pain, low grade fever, chills, sweating, upset stomach, fatigue and dizziness. In November 2019, the outcome of the influenza-like symptoms was recovered/resolved. On an unknown date, the outcome of the faint, injection site pain, pain in thigh, shallow breathing, general body pain, low grade fever, chills, sweating, upset stomach, fatigue, dizziness, injection site rash and injection site swelling were not recovered/not resolved.   Additional details were reported as follows: On 21st November 2019, patient received flu vaccine and experienced  flu like symptoms that resolved 2 days later. On 23rd November 2019, Patient received 1st dose of Shingrix vaccine and that night experienced pain in arm at injection site, pain at different spots on her upper right thigh, shallow breathing, body aches, low grade fever, shivering, chills, sweating, upset stomach and feeling exhausted, faint and dizzy. The reporter also reported that the patient experienced rash and swelling at injection site on the right arm.. The events were gotten somewhat better but did not resolved at the time of reporting. The reporter consented to follow up.  It was unknown if the reporter considered the faint, influenza-like symptoms, injection site pain, pain in thigh, shallow breathing, general body pain, low grade fever, chills, sweating, upset stomach, fatigue, dizziness, injection site rash and injection site swelling to be related to Shingrix. It was unknown if the reporter considered the faint, influenza-like symptoms, injection site pain, pain in thigh, shallow breathing, general body pain, low grade fever, chills, sweating, upset stomach, fatigue and dizziness to be related to Influenza vaccine Quadrivalent unspecified season.