Sex: U
Vaccine: COVID19, FLUA4
Symptoms: Muscle spasms, Pain, Pyrexia
Clinical narrative: Aches; Excruciating leg cramps in the night; Every bone in body hurt; Headache; Fever; Joint pain; Chills; GI issues similar to IBS; This spontaneous case was received on 06-Mar-2024 from other non-healthcare professional (consumer) via Communications (reference number: SEQW24-00837) and concerned a patient of an unreported age and gender.  The patient's concurrent conditions included allergy to codeine and eye discomfort. The patient's concomitant medication included latanoprost, used for eye discomfort.  On 23-Oct-2023, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine inact sag 4v; dose: reported as 'one dosage form (1 DF)', route of administration: intramuscular, anatomical location and indication: not reported). The batch number reported was 371633.   On the same date, the patient was vaccinated with COVID-19 vaccine (reported as 'mRNA-1273.815 (SPIKEVAX 2023-2024)' (active ingredients not specified)) (dose: reported as 'one dosage form (1 DF)', route of administration: intramuscular, anatomical location: not reported) for COVID-19 prophylaxis. The batch number reported was 303047B.  On the same date, at 4:00 PM, after receiving Fluad Quadrivalent and non-company, co-suspect COVID-19 vaccine, the patient experienced excruciating leg cramps in the night, fever, chills, every bone in their body hurt, headache and joint pain.   On 24-Oct-2023, the patient experienced aches. The patient was treated with Aleve (naproxen sodium) at an unspecified dose and frequency.   On an unspecified date in Oct-2023, the patient experienced gastrointestinal (GI) issues similar to irritable bowel syndrome (IBS).  On 25-Oct-2023, the patient recovered from the event of 'bone pain'.  On 30-Oct-2023, the patient recovered with sequelae from events of leg cramps, fever, chills, and joint pain.  At the time of initial reporting, the patient was recovering from the events of 'ache', 'gastrointestinal disorder' and headache.  The reporter did not provide a causality assessment.  The case was assessed as non-serious.  Company comment: A patient of an unreported age and gender was vaccinated with Fluad Quadrivalent and non-company, co-suspect COVID-19 vaccine. On the same day the patient experienced excruciating leg cramps in the night, fever, chills, every bone in their body hurt, headache and joint pain. One day following vaccination, the patient experienced pain. Within a couple of days after receiving vaccines, the patient also experienced gastrointestinal disorder. Although confounded by administration of COVID-19 vaccine, causality is assessed as possible for all reported events, due to chronological plausibility.; Sender's Comments: A patient of an unreported age and gender was vaccinated with Fluad Quadrivalent and non-company, co-suspect COVID-19 vaccine. On the same day the patient experienced excruciating leg cramps in the night, fever, chills, every bone in their body hurt, headache and joint pain. One day following vaccination, the patient experienced pain. Within a couple of days after receiving vaccines, the patient also experienced gastrointestinal disorder. Although confounded by administration of COVID-19 vaccine, causality is assessed as possible for all reported events, due to chronological plausibility.