Sex: F
Vaccine: FLUC3
Symptoms: Arthralgia, Blood pressure increased, Fatigue, Formication, Gait disturbance
Clinical narrative: Panic attack; Anxiety; Muscle spasms; Elevated blood pressure; Stress; Heart palpitations; Fatigue; Joint pain; Tingling (pins and needles) as if something was crawling on her right leg, left leg, right arm and left arm; Skin felt like it was burning; Numbness; Muscle weakness; This spontaneous case was received on 25-Mar-2021 from other non-health professional (consumer) via (reference number: SEQW21-01070) and concerned a female patient, of an unreported age.   The patient had no relevant medical history. The patient's concomitant medications included Flonase (fluticasone propionate) and not specified multivitamins, both used for an unreported indication. The patient never had reaction to vaccine before.   On 15-Sep-2019, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine, subunit influenza virus vaccine polyvalent, dose: 0.5 ml, anatomical location: right arm and route of administration: not reported). The batch number was not reported.  On the same day, three to four hours after receiving Flucelvax Quadrivalent, the patient experienced tingling and numbness. She had tingling (pins and needles) as if something was crawling on her right leg. Her skin felt like it was burning, and she experienced joint pain, muscle spasms followed by muscle weakness not so bad that she couldn't walk but would cause fatigue.  On 16-Sep-2019, the next morning (as reported), tingling continued in the right leg and started in left leg. Later that day, it was in both legs and left arm, then the feeling moved to the right arm. It was transient as she felt it was moving around her body.   On an unspecified date, the patient seen her primary care physician, rheumatologist and a neurologist.  On an unspecified date, the patient was seen in the emergency room for heart palpitations and elevated blood pressure and was diagnosed with panic attach due to stress. She was offered medication for anxiety, but she refused it, as she did not want to take this kind of medicine.   At the time of initial reporting on 25-Mar-2021, the patient had not recovered from events of 'tingling', numbness, 'skin burning', joint pain, muscle spasms and muscle weakness. The patient was still experiencing these symptoms, but they were not as severe.  The outcome of fatigue, panic attack, anxiety, blood pressure increased, palpitations and stress was not reported.   The patient did not provide causality assessment, but it was reported that all physicians felt that patient's reaction was caused by the vaccine.  Company comment: A female patient, of an unreported age developed hypoaesthesia, paraesthesia, skin burning sensation, arthralgia, muscle spasms, muscular weakness, and fatigue on the same day after vaccination with the suspect product, Flucelvax Quadrivalent. An unknown amount of time after vaccination the patient visited emergency room for panic attack, anxiety, blood pressure increased, stress, and palpitations. Information regarding the related diagnostic findings have not been provided. Due to lack of information regarding the temporal relationship, causality for the events panic attack, anxiety, blood pressure increased, stress, and palpitations is unassessable. Based on suggestive time relationship, causality for all other events is assessed as possibly related.; Reporter's Comments: All physicians felt that patient's reaction was caused by the vaccine.; Sender's Comments: A female patient, of an unreported age developed hypoaesthesia, paraesthesia, skin burning sensation, arthralgia, muscle spasms, muscular weakness, and fatigue on the same day after vaccination with the suspect product, Flucelvax Quadrivalent. An unknown amount of time after vaccination the patient visited emergency room for panic attack, anxiety, blood pressure increased, stress, and palpitations. Information regarding the related diagnostic findings have not been provided. Due to lack of information regarding the temporal relationship, causality for the events panic attack, anxiety, blood pressure increased, stress, and palpitations is unassessable. Based on suggestive time relationship, causality for all other events is assessed as possibly related.