Age: 27.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Headache, Malaise, Muscle fatigue, Musculoskeletal stiffness
Clinical narrative: One bouth of diarrhoea; Headache; Lightheadedness; Stomach upset; Muscle stiffness / stiffness in my upper back, shoulders, and neck; General feeling of being unwell; Back pain; Back and neck muscles progressively became more sore / muscle aches (particular in the upper back and shoulders); Muscle fatigue; Felt easily agitated; Felt easily anxious; Depression; This spontaneous case was retrieved on 24-Dec-2020 from Vaccine Adverse Event Reporting System (VAERS) (reference number: 892273-1) reported by other non-health professional (consumer) and concerned a 27-year-old, female patient.  The patient's concurrent condition included generalised anxiety disorder which was under control. The patient's concomitant medications included Tri Lo Marzia (ethinylestradiol, norgestimate) used as birth control, Zyrtec (cetirizine hydrochloride), Nasacort (triamcinolone acetonide), Lexapro (escitalopram oxalate) and melatonin, all used for an unreported indication. The patient's historical vaccine included unspecified influenza vaccine (reported as GlaxoSmithKline (GSK) Quadrivalent vaccine from 08-Oct-2019) with muscle aches/fatigue, headache and anxiety as adverse events.  On 02-Oct-2020, the patient was vaccinated with Afluria Quadrivalent (influenza vaccine; dose: reported as one, route of administration: intramuscular, anatomical location: left arm and indication: not reported). The batch number reported was P100247218.   On 04-Oct-2020, two days after receiving Afluria Quadrivalent, the patient developed a feeling of being unwell and muscle stiffness during her runs.   On an unspecified day in Oct-2020, during period from 02-Oct-2020 to 08-Oct-2020, the patient felt some mild depression that she did not have before the flu shot. Her symptoms began improving over the course of that week.   On an unspecified day in Oct-2020, around 09-Oct-2020, the patient's back and neck muscles progressively became more sore and she felt a little muscle fatigue.   On 11-Oct-2020, on midday, the patient started to feel more muscle aches (particular in the upper back and shoulders), light-headedness, headache, and stomach upset. These symptoms were similar than to what she felt the week prior, but they increased in severity. In the following days patient continued to have muscle aches and stiffness in her upper back, shoulders, and neck and felt easily agitated/anxious.   On 21-Oct-2020, 19 days after receiving Afluria Quadrivalent, the patient experienced one bout of diarrhoea.  On the same day, the patient recovered from diarrhoea.   At the time of initial reporting, the patient was recovering from all other events. Her symptoms gradually began to improve after 21-Oct-2020, but the back pain and anxiety had not completely resolved.  The reporter did not provide causality assessment.  This case was assessed as non-serious.  Company Comment: A 27-year-old, female patient developed depression, musculoskeletal stiffness, muscle fatigue, abdominal discomfort, agitation, anxiety, dizziness, back pain, myalgia, diarrhoea, headache and malaise after vaccination with the suspect product, Afluria quadrivalent. The patient's concurrent condition of generalised anxiety disorder confounds causality in a significant way. Causality is significantly confounded by therapy with concomitant drugs Tri Lo Marzia (ethinylestradiol, norgestimate), Zyrtec (cetirizine hydrochloride), Nasacort (triamcinolone acetonide) and Lexapro (escitalopram oxalate). Although confounding factor is present, causality of the suspect product cannot be totally excluded. Therefore, causality for all events is assessed as possible (defaults to related in the safety database for reporting purposes).; Sender's Comments: A 27-year-old, female patient developed depression, musculoskeletal stiffness, muscle fatigue, abdominal discomfort, agitation, anxiety, dizziness, back pain, myalgia, diarrhoea, headache and malaise after vaccination with the suspect product, Afluria quadrivalent. The patient's concurrent condition of generalised anxiety disorder confounds causality in a significant way. Causality is significantly confounded by therapy with concomitant drugs Tri Lo Marzia (ethinylestradiol, norgestimate), Zyrtec (cetirizine hydrochloride), Nasacort (triamcinolone acetonide) and Lexapro (escitalopram oxalate). Although confounding factor is present, causality of the suspect product cannot be totally excluded. Therefore, causality for all events is assessed as possible (defaults to related in the safety database for reporting purposes).