Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site pain, Lethargy, Lymph node pain, Lymphadenopathy, Myalgia
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient. A 62-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Dec2021 as dose 3 (booster), single (Lot number: 33030BD) at the age of 62 years, in left arm for Covid-19 immunisation. The patient's relevant medical history included: "Stage 1 Hypertension" (unspecified if ongoing), notes: Stage 1 Hypertension; "Mild sleep apnea" (unspecified if ongoing), notes: Mild sleep apnea. Concomitant medication(s) included: COZAAR. Past drug history included: Keflex, reaction(s): "Known allergies: Keflex", notes: Known allergies: Keflex. Vaccination history included: BNT162b2 (Dose Number: 1; Batch/Lot No: EL9265; Location of injection: Arm Left), administration date: 12Feb2021, when the patient was 61-year-old, for COVID-19 immunization, reaction(s): "Mild headache", "Moderate fatigue exacerbated with activity"; BNT162b2 (Dose Number: 2; Batch/Lot No: EN6199; Location of injection: Arm Left; Unresolved memory loss), administration date: 09Mar2021, when the patient was 61-year-old, for COVID-19 immunization, reaction(s): "Unresolved memory loss", "Confusion", "Cognitive delay", "Mild headache", "Moderate fatigue exacerbated with activity". The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, was the patient was not diagnosed with COVID-19. The following information was reported: HEADACHE (disability), outcome "not recovered", described as "Mild headache"; FATIGUE (disability), outcome "not recovered", described as "Moderate fatigue exacerbated with activity"; AMNESIA (disability), outcome "not recovered", described as "Unresolved memory loss"; CONFUSIONAL STATE (disability), outcome "not recovered", described as "Confusion"; COGNITIVE DISORDER (disability), outcome "not recovered", described as "Cognitive delay"; PAIN IN EXTREMITY (disability), MUSCULAR WEAKNESS (disability), outcome "not recovered" and all described as "Unresolved pain and weakness in both arms". The events "mild headache", "moderate fatigue exacerbated with activity", "unresolved memory loss", "confusion", "cognitive delay" and "unresolved pain and weakness in both arms" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (21Feb2021) Negative, notes: Covid test type post vaccination=Nasal Swab; (22Feb2021) Negative, notes: Covid test type post vaccination=Nasal Swab. Therapeutic measures were not taken as a result of headache, fatigue, amnesia, confusional state, cognitive disorder, pain in extremity, muscular weakness. Reported Events for 1st dose: Unresolved mild headache and moderate fatigue exacerbated with activity; 2nd dose: In addition to unresolved side effects from the 1st dose, unresolved memory loss, confusion, and cognitive delay. 3rd dose: In addition to unresolved side effects from 1st and 2nd doses, unresolved pain and weakness in both arms. As a result of these unresolved side effects, initially worked a modified schedule of 4 hours/day beginning 20Apr2021 and now no longer able to work at all effective 16Aug2021 as a public health nurse. No hospitalization prolonged. The adverse event resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient has been tested for COVID-19. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Sender's Comments: As there is limited information in the case provided, the causal association between the event Headache, Fatigue, Amnesia, confusion, cognitive function abnormal, pain in arm and Weakness of arm and the suspect drug cannot be excluded. The case will be reassessed once new information is available.