Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Musculoskeletal stiffness, Pain, Pyrexia, Rash
Clinical narrative: Bilateral ear swelling; Bilateral ear swelling, redness; Bilateral ear swelling, redness, and itching; Joint soreness; Tendon soreness; Stiffness in shoulders/Stiffness in hands; Dose 3 was administered before 6 months; Dose received 3/dose number 3; Rash bilateral upper neck, rash behind ears and upper neck still persists intermittently; Low grade fever; Body aches; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 41 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 03Nov2021 08:30 (Lot number: FF2589) at the age of 41 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: TURMERIC [CURCUMA LONGA RHIZOME]; VITAMIN B [VITAMIN B NOS]. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot number: BK9231, Anatomical location: Left arm, Route of administration: unspecified), administration date: 30Dec2020, when the patient was 40 years old, for COVID-19 immunisation; Bnt162b2 (DOSE 2, SINGLE, Lot number: EZ8982, Anatomical location: Left arm, Route of administration: unspecified), administration date: 20Jun2021, when the patient was 41 years old, for COVID-19 immunisation, reaction(s): "Inappropriate schedule of vaccine administered". The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 03Nov2021 08:30, outcome "unknown", described as "Dose 3 was administered before 6 months"; IMMUNISATION (non-serious) with onset 03Nov2021 08:30, outcome "unknown", described as "Dose received 3/dose number 3"; EAR SWELLING (non-serious) with onset 03Nov2021 09:00, outcome "recovered with sequelae" (2021), described as "Bilateral ear swelling"; ERYTHEMA (non-serious) with onset 03Nov2021 09:00, outcome "recovered with sequelae" (2021), described as "Bilateral ear swelling, redness"; EAR PRURITUS (non-serious) with onset 03Nov2021 09:00, outcome "recovered with sequelae" (2021), described as "Bilateral ear swelling, redness, and itching"; RASH (non-serious) with onset Nov2021, outcome "not recovered", described as "Rash bilateral upper neck, rash behind ears and upper neck still persists intermittently"; PYREXIA (non-serious) with onset Nov2021, outcome "recovered with sequelae" (2021), described as "Low grade fever"; PAIN (non-serious) with onset Nov2021, outcome "recovered with sequelae" (2021), described as "Body aches"; ARTHRALGIA (non-serious) with onset 03Nov2021 09:00, outcome "recovered with sequelae" (2021), described as "Joint soreness"; TENDON PAIN (non-serious) with onset 03Nov2021 09:00, outcome "recovered with sequelae" (2021), described as "Tendon soreness"; MUSCULOSKELETAL STIFFNESS (non-serious) with onset 03Nov2021 09:00, outcome "recovered with sequelae" (2021), described as "Stiffness in shoulders"; MUSCULOSKELETAL STIFFNESS (non-serious) with onset 03Nov2021 09:00, outcome "recovered with sequelae" (2021), described as "Stiffness in hands". The events "bilateral ear swelling", "bilateral ear swelling, redness", "bilateral ear swelling, redness, and itching", "rash bilateral upper neck, rash behind ears and upper neck still persists intermittently", "low grade fever", "body aches", "joint soreness", "tendon soreness", "stiffness in shoulders" and "stiffness in hands" were evaluated at the physician office visit. Therapeutic measures were taken as a result of ear swelling, erythema, ear pruritus, rash, pyrexia, pain, arthralgia, tendon pain, musculoskeletal stiffness, musculoskeletal stiffness which included treatment with steroid shot and dose pack.  Additional Information: The patient had no known allergies. On day 5-6 it progressed to a rash bilateral upper neck, low grade fever, body aches. Events of bilateral ear swelling, redness and itching started that same day. Event of rash behind ears and upper neck still persists intermittently. The patient did not receive any other vaccines within four weeks prior to COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  Follow-up attempts are completed . No further information is expected.