Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Hot flush, Hyperhidrosis, Insomnia, Myalgia
Clinical narrative: intense hot flashes with a lot of sweating, restless bilateral legs and arms (which she cannot take medication for), muscle pain and weakness/Reporter also states that she has experienced these side effects after her previous COVID-19 vaccines; intense hot flashes with a lot of sweating, restless bilateral legs and arms (which she cannot take medication for), muscle pain and weakness/Reporter also states that she has experienced these side effects after her previous COVID-19 vaccines; intense hot flashes with a lot of sweating, restless bilateral legs and arms (which she cannot take medication for), muscle pain and weakness/Reporter also states that she has experienced these side effects after her previous COVID-19 vaccines; intense hot flashes with a lot of sweating, restless bilateral legs and arms (which she cannot take medication for), muscle pain and weakness/Reporter also states that she has experienced these side effects after her previous COVID-19 vaccines; intense hot flashes with a lot of sweating, restless bilateral legs and arms (which she cannot take medication for), muscle pain and weakness/Reporter also states that she has experienced these side effects after her previous COVID-19 vaccines; she so tired and weak from the lack of sleep; intense hot flashes with a lot of sweating, restless bilateral legs and arms (which she cannot take medication for), muscle pain and weakness/Reporter also states that she has experienced these side effects after her previous COVID-19 vaccines; This spontaneous case was reported by a patient and describes the occurrence of HOT FLUSH (intense hot flashes with a lot of sweating, restless bilateral legs and arms (which she cannot take medication for), muscle pain and weakness/Reporter also states that she has experienced these side effects after her previous COVID-19 vaccines), HYPERHIDROSIS (intense hot flashes with a lot of sweating, restless bilateral legs and arms (which she cannot take medication for), muscle pain and weakness/Reporter also states that she has experienced these side effects after her previous COVID-19 vaccines), RESTLESS LEGS SYNDROME (intense hot flashes with a lot of sweating, restless bilateral legs and arms (which she cannot take medication for), muscle pain and weakness/Reporter also states that she has experienced these side effects after her previous COVID-19 vaccines), RESTLESS ARM SYNDROME (intense hot flashes with a lot of sweating, restless bilateral legs and arms (which she cannot take medication for), muscle pain and weakness/Reporter also states that she has experienced these side effects after her previous COVID-19 vaccines) and ASTHENIA (intense hot flashes with a lot of sweating, restless bilateral legs and arms (which she cannot take medication for), muscle pain and weakness/Reporter also states that she has experienced these side effects after her previous COVID-19 vaccines) in a 59-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    Concurrent medical conditions included Rheumatoid arthritis since 2000 and Fibromyalgia since 2000.   On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form and dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient experienced HOT FLUSH (intense hot flashes with a lot of sweating, restless bilateral legs and arms (which she cannot take medication for), muscle pain and weakness/Reporter also states that she has experienced these side effects after her previous COVID-19 vaccines), HYPERHIDROSIS (intense hot flashes with a lot of sweating, restless bilateral legs and arms (which she cannot take medication for), muscle pain and weakness/Reporter also states that she has experienced these side effects after her previous COVID-19 vaccines), RESTLESS LEGS SYNDROME (intense hot flashes with a lot of sweating, restless bilateral legs and arms (which she cannot take medication for), muscle pain and weakness/Reporter also states that she has experienced these side effects after her previous COVID-19 vaccines), RESTLESS ARM SYNDROME (intense hot flashes with a lot of sweating, restless bilateral legs and arms (which she cannot take medication for), muscle pain and weakness/Reporter also states that she has experienced these side effects after her previous COVID-19 vaccines), ASTHENIA (intense hot flashes with a lot of sweating, restless bilateral legs and arms (which she cannot take medication for), muscle pain and weakness/Reporter also states that she has experienced these side effects after her previous COVID-19 vaccines), INSOMNIA (she so tired and weak from the lack of sleep) and MYALGIA (intense hot flashes with a lot of sweating, restless bilateral legs and arms (which she cannot take medication for), muscle pain and weakness/Reporter also states that she has experienced these side effects after her previous COVID-19 vaccines). At the time of the report, HOT FLUSH (intense hot flashes with a lot of sweating, restless bilateral legs and arms (which she cannot take medication for), muscle pain and weakness/Reporter also states that she has experienced these side effects after her previous COVID-19 vaccines), HYPERHIDROSIS (intense hot flashes with a lot of sweating, restless bilateral legs and arms (which she cannot take medication for), muscle pain and weakness/Reporter also states that she has experienced these side effects after her previous COVID-19 vaccines), RESTLESS LEGS SYNDROME (intense hot flashes with a lot of sweating, restless bilateral legs and arms (which she cannot take medication for), muscle pain and weakness/Reporter also states that she has experienced these side effects after her previous COVID-19 vaccines), RESTLESS ARM SYNDROME (intense hot flashes with a lot of sweating, restless bilateral legs and arms (which she cannot take medication for), muscle pain and weakness/Reporter also states that she has experienced these side effects after her previous COVID-19 vaccines), ASTHENIA (intense hot flashes with a lot of sweating, restless bilateral legs and arms (which she cannot take medication for), muscle pain and weakness/Reporter also states that she has experienced these side effects after her previous COVID-19 vaccines), INSOMNIA (she so tired and weak from the lack of sleep) and MYALGIA (intense hot flashes with a lot of sweating, restless bilateral legs and arms (which she cannot take medication for), muscle pain and weakness/Reporter also states that she has experienced these side effects after her previous COVID-19 vaccines) had resolved.        For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Reporter stated that she did have some of these adverse reactions with her previous COVID-19 vaccines (mixture of both Pfizer and Moderna) but not as strong/intense. They lasted 6 to 8 weeks. No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2024-761249 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 21-Feb-2024: Live Significant follow up added: events and reference ids updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-761249:Same Patient different Dose