Age: 53.0
Sex: F
Vaccine: FLUC3
Symptoms: Restlessness
Clinical narrative: Lower backache began early afternoon/By bedtime, significant amount of pain; Restlessness; Limited mobility/I was not able to walk without assistance; Painful at the location of administration - more so than typical; This spontaneous case was retrieved on 24-Aug-2022 from Vaccine Adverse Event Reporting System (VAERS) (reference number: 1836914-1), reported by other healthcare professional and concerned a 53-year-old, female patient.  The patient's current condition included degenerative disk. The patient's historical conditions included back pain, and sciatic nerve pain, experienced approximately 20 years ago. The patient was not taking any concomitant medications. The patient's historical drug included epidural steroid injection, received 20 years ago. The patient's historical vaccines included third dose of Pfizer BioNTech COVID-19 vaccine (tozinameran), received on 07-Oct-2021, for an unreported indication, after which the patient experienced extreme fatigue, nausea, dizziness and fainting spell. The patient had no known allergies.   On 15-Oct-2021, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine inact sag 4v; route of administration: intramuscular; anatomical location: left arm; dose and indication: not reported). The batch number reported was 308472 (reported batch number was identified by Seqirus to be linked to suspect product Flucelvax Quadrivalent instead of reported suspect product Fluad Quadrivalent). The injection was audible, which was unusual, and painful at the location of administration, more so than typical.  On 15-Oct-2021, after receiving Flucelvax Quadrivalent, the patient experienced lower backache that began early afternoon. By bedtime, the patient experienced significant amount of pain, causing restlessness and limited mobility. Pain was extreme and debilitating, but transient.  On 16-Oct-2021, reported as 'by morning', pain had increased comparable to that of sciatic nerve pain the patient experienced approximately 20 years ago. The patient had not had that degree of pain since then. The patient was not able to walk without assistance.  On unspecified date in Oct-2021, the patient was self-treated with unspecified non-steroidal anti-inflammatory drugs (NSAIDs) and pain diminished over next 24 to 48 hours.  On unspecified date in Oct-2021, the patient recovered from all the events.  The reporter assessed all the events as related to Flucelvax Quadrivalent, stating that only contributing factor seemed to be the flu vaccine. The patient was not experiencing any pain prior to vaccination and onset was within hours of receiving vaccine.   The case was assessed as non-serious.  Company comment: A 53-year-old female patient experienced vaccination site pain, back pain, restlessness and decreased mobility on the same date after receiving Fluacelvax Quadrivalent. Causality for restlessness is assessed as not related since a concomitant condition provides a plausible etiology. Causality for the rest of the events is assessed as possibly related due to plausible temporal relationship.; Reporter's Comments: The reporter assessed all the events as related to Flucelvax Quadrivalent, stating that only contributing factor seemed to be the flu vaccine. The patient was not experiencing any pain prior to vaccination and onset was within hours of receiving vaccine.; Sender's Comments: A 53-year-old female patient experienced vaccination site pain, back pain, restlessness and decreased mobility on the same date after receiving Fluacelvax Quadrivalent. Causality for restlessness is assessed as not related since a concomitant condition provides a plausible etiology. Causality for the rest of the events is assessed as possibly related due to plausible temporal relationship.