Sex: F
Vaccine: FLUX, UNK, VARZOS
Symptoms: Depression, Dizziness, Fatigue, Feeling abnormal, Hangover
Clinical narrative: felt was coming down with a cold; flu like symptoms; whoozy; heart started to race; extremely tired; difficulty sleeping; malaise; increased aches and pains; kidney function is down; bruise when she injected; felt hung over; depressive state; felt foggy; This case was reported by a consumer via other manufacturer and described the occurrence of renal impairment in a 62-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 and abaloparatide (Tymlos) for senile osteoporosis.   Concurrent medical conditions included senile osteoporosis. Concomitant products included quetiapine.   On an unknown date, the patient received Shingrix and Influenza vaccine Quadrivalent unspecified season. On 10th August 2021, the patient started Tymlos (subcutaneous) 80 ug once daily (80 ug daily). On 24th August 2021, unknown after receiving Shingrix and Influenza vaccine Quadrivalent unspecified season, the patient experienced renal impairment (serious criteria GSK medically significant), injection site bruising, hangover, depression, foggy feeling in head, fatigue, difficulty sleeping, malaise and pain. On 19th September 2021, the patient experienced wooziness and heartbeats increased. In October 2021, the patient experienced nasopharyngitis and influenza-like symptoms. Tymlos was continued with no change. On an unknown date, the outcome of the renal impairment, injection site bruising, hangover, depression, foggy feeling in head, nasopharyngitis, influenza-like symptoms, fatigue, difficulty sleeping, malaise and pain were unknown and the outcome of the wooziness and heartbeats increased were recovered/resolved.   It was unknown if the reporter considered the renal impairment, injection site bruising, hangover, depression, foggy feeling in head, nasopharyngitis, influenza-like symptoms, wooziness, fatigue, difficulty sleeping, malaise, pain and heartbeats increased to be related to Shingrix and Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced dizziness, heart rate increased, fatigue (extreme intensity), renal impairment, injection site bruising, hangover (in the morning), depression, insomnia, feeling abnormal (felt foggy during the day), malaise, pain (increased), nasopharyngitis and influenza like illness. The patient did not take Tymlos and quetiapine for 2 days at bedtime. The patient noted she had taken quetiapine for 2 months prior to Tymlos and felt more energy and was more motivated the 2 days off Tymlos. After the patient had the Shingrix Vaccine (zoster vaccine recombinant, adjuvant) and Influenza vaccinations she held her Tymlos doses from 5th October 2021 to 8th October 2021 or three to seven days due to experiencing flu like symptoms. She felt better while not taking Tymlos. The patient laid down and events of dizziness and heart rate increased resolved.  No treatment was reported. No relevant lab or diagnostic tests were reported. The action taken with Tymlos treatment was dose not changed.  It was unknown if the reporter considered the renal impairment, hangover, depression, foggy feeling in head, nasopharyngitis, influenza-like symptoms, wooziness, heartbeats increased, fatigue, injection site bruising, difficulty sleeping, malaise and pain to be related to Tymlos.