Age: 64.0
Sex: M
Vaccine: COVID19-2, FLU4
Symptoms: Arthralgia, Hyposmia, Taste disorder
Clinical narrative: Hip pain; Unable to taste food except for salt, sweet, bitter and sour/ absence of taste in foods/ still can detect tongue tastes (salt, sweet, bitter, sour), but other tastes are almost non-existent; Diminished ability to smell; This spontaneous case from United States was received on 05-Feb-2024 from other non-healthcare professional (consumer) via Communications (reference number: SEQW24-00503) and concerned a 64-year-old, male patient.  The patient's medical history included Covid-19 (unknown if ongoing). The patient's concurrent conditions included hay fever, high cholesterol, acid reflux, coronary artery disease (CAD), erectile dysfunction and insomnia. The patient's concomitant medications included famotidine and omeprazole, both used for acid reflux, ezetimibe, atorvastatin and fish oil, all used for high cholesterol, loratadine, used for an unspecified allergies, Aspirin (acetylsalicylic acid), used for coronary arthery disease, Mature Multivitamins (ascorbic acid, biotin, boron, calcium, chromium, copper, folic acid, ginseng nos, iodine, magnesium, manganese, menadione, molybdenum, nicotinic acid, pantothenic acid, phosphorus, potassium, potassium chloride, pyridoxine hydrochloride, retinol, riboflavin, selenium, silicon, thiamine, tocopherol, vitamin b12 nos, vitamin d nos, xantofyl, zinc), Vitamin D3 (colecalciferol) and vitamin E, all used for general health, as reported, sildenafil citrate used for erectile dysfunction and acetaminophen;diphenhydramine hydrochloride, used for insomnia. The patient's historical vaccines included three doses of Pfizer Covid-19 vaccines, first dose received on 25-Apr-2023, second dose on 16-May-2021 and third dose on 15-Jul-2022, and two doses of Moderna Covid-19 vaccines, first dose received on 07-Dec-2021 (batch number: 030H21B) and second dose on 31-Jan-2023 (batch number: AS7171B), all for an unreported indication.    On 17-Aug-2023, the patient was vaccinated with Afluria Quadrivalent (influenza vaccine inact sag 4v; dose: 0.5 ml, route of administration: intramuscular; anatomical location: bicep) as active immunisation against influenza disease. The batch number reported was AU1058A.   On the same date at 01:30 pm, the patient was vaccinated with a non-company, co-suspect Moderna COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5) (davesomeran, elasomeran; dose: 0.5 ml, route of administration: intramuscular, anatomical location: bicep and indication: not reported). The reported batch number was AS7646C.  On 20-Aug-2023, three days after receiving Afluria Quadrivalent and non-company co-suspect Moderna COVID-19 vaccine, the patient was unable to taste food except for salt, sweet, bitter and sour, and experienced diminished ability to smell and hip pain. The patient still could detect tongue tastes (salt, sweet, bitter, sour), but other tastes were almost non-existent.  On 12-Sep-2023, the patient stopped using Tylenol (acetaminophen) with sleep aid after reading that long term use of acetaminophen could cause liver damage.  On an unspecified date in 2023, the patient recovered from the event of  'pain in hip'. As reported, it lasted for a couple of days and had gone away.  On 02-Oct-2023, the patient saw a otorhinolaryngology (ENT) specialist, who recommended using fluticasone propionate, two sprays in each nostril, two times a day. Also, it was ordered a computerized tomography (CT) scan of sinuses with coronals, which was scheduled for 23-Oct-2023.  At the time of the initial reporting, the patient had not recovered from the events of 'impaired taste' and 'diminished sense of smell'.  The reporter did not provide a causality assessment. The patient has not had an illness since the booster/flu combination that might explain the issue and the patient did not have any issue with tasting foods prior to this, as reported. In addition, the patient was not aware of any taste/smell side affects in connection with the dyphenhydramine (sleep aid ingredient) use.    The case was assessed as non-serious.  Company comment: A 64-year-old patient was vaccinated with Afluria Quadrivalent and non-company, co-suspect Moderna COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5). Three days following vaccination, the patient experienced arthralgia, taste disorder and hyposmia. Although confounded by administration of co-suspect vaccine, causality is assessed as possible for all reported events, due to chronological plausibility.; Reporter's Comments: The patient has not had an illness since the booster/flu combination that might explain the issue and the patient did not have any issue with tasting foods prior to this, as reported.; Sender's Comments: A 64-year-old patient was vaccinated with Afluria Quadrivalent and non-company, co-suspect Moderna COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5). Three days following vaccination, the patient experienced arthralgia, taste disorder and hyposmia. Although confounded by administration of co-suspect vaccine, causality is assessed as possible for all reported events, due to chronological plausibility.