Age: 60.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Hypokinesia, Insomnia, Limb discomfort, Pain in extremity, Vaccination site pain
Clinical narrative: she has been feeling pain in the right arm, where she received the injection; difficult to sleep; difficulty to lift this arm and the problem is not getting better.; arm pain is unbearable and it is difficult to do much with; right arm; feels like 100 pounds in right arm, up half the night, pain starts at her shoulder and goes down her entire arm; arm pain is unbearable and it is difficult to do much with; right arm; feels like 100 pounds in right arm, up half the night, pain starts at her shoulder and goes down her entire arm; This is a spontaneous report received from contactable reporter(s) (Other HCP) from medical information team. The reporter is the patient.  A 60 year-old female patient received bnt162b2 (COMIRNATY), administered in arm right, administration date 13Jan2022 (Lot number: TJ1614) at the age of 60 years as dose 3 (booster), single for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), administered in arm left, administration date 13Jan2022 (Batch/Lot number: unknown) as single dose. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot number: ER8730), administration date: 30Mar2021, when the patient was 59 years old, for COVID-19 Immunization, reaction(s): "Achy Arm"; Bnt162b2 (DOSE 2, SINGLE, Lot number: EP7533), administration date: 20Apr2021, when the patient was 59 years old, for COVID-19 Immunization, reaction(s): "Achy Arm". The following information was reported: PAIN IN EXTREMITY (disability), LIMB DISCOMFORT (disability) all with onset 13Jan2022, outcome "not recovered" and all described as "arm pain is unbearable and it is difficult to do much with; right arm; feels like 100 pounds in right arm, up half the night, pain starts at her shoulder and goes down her entire arm"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "she has been feeling pain in the right arm, where she received the injection"; INSOMNIA (non-serious), outcome "unknown", described as "difficult to sleep"; HYPOKINESIA (non-serious), outcome "not recovered", described as "difficulty to lift this arm and the problem is not getting better.". Therapeutic measures were taken as a result of pain in extremity, limb discomfort, vaccination site pain, insomnia, hypokinesia.  Clinical course: The patient reported that ever since booster dose, she has been feeling pain in the right arm  (where she received the injection), difficult to sleep and also she has had difficulty to lift this arm and the problem is not getting better. The pain started right after she got the shot and it never got any better. It felt like there was 100 pounds in her right arm. The patient felt it was disabling, she was up half the night with it. The patient, being a nurse, she looked at where the band aid was, and it was quite high. She asked the girl that administered her the vaccine where she went to nursing school and she said she just started nursing school. The patient doesn't understand why they have people giving shots that aren't certified. The patient stated the people were nurses that gave them to her before. The patient stated she was talking to the girl because the caller had taught nursing before, and the girl that gave the shot said that (withheld )does not hire nurses anymore. The events did not require a visit to emergency room of physician office but she has an appointment with one. It was taking a while to get in because the PCP was just going to send her to an orthopedic doctor. The patient had no prior vaccinations within four weeks. The patient stated arm pain was unbearable and it was difficult to do much with; right arm; felt like 100 pounds in right arm, up half the night, pain started at her shoulder and goes down her entire arm was related.; Sender's Comments: Based on the available information, there is a reasonable possibility of a causal relationship between the suspect vaccine BNT162B2 (COMIRNATY) and reported events which cannot be fully assessed/excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.  ,Linked Report(s) : US-PFIZER INC-202200416602 same patient/product, similar event, different dose