Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Epistaxis, Facial pain, Full blood count, Headache
Clinical narrative: Nosebleed; Cramp on lower extremities/ Fingers were also having cramps; Fingers were frozen and locked.; Fingers were frozen and locked.; Unable to move it; Leg pain/ patient had pain at her fingers; Feeling weak; headache; facial pain; Pain and swelling  at the left side of the arm or site of injection; pain and swelling  at the left side of the arm or site of injection; This is a spontaneous report from a contactable physician. A 68-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EN6201; expiration date: Jun2021), dose 2 via an unspecified route of administration, administered in Arm Left on 04Mar2021 (received at the age 68-year-old) as 2ND DOSE, SINGLE for COVID-19 immunization. Medical history included ongoing hypothyroidism from an unspecified date. Concomitant medications were none. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL92109, expiry date: May2021) on 11Feb2021 (received at the age 68-year-old) for COVID-19 immunization. The reporter is a physician calling on behalf of her patient. The patient is a 68-year-old female. She received the 2 doses of the Pfizer Covid Vaccine. The patient did good on the first dose but on the second dose, she reported pain and swelling at the left side of the arm or site of injection on 04Mar2021. The patient had arm swelling on the left side which was on the same side as injection. The pain at the site was around a 10 on the scale.The patient also reported cramp on lower extremities, feeling weak, leg pain and unable to move it on 04Mar2021. The patient reported cramps in lower extremities and weakness. The patient also had nosebleed 2 days prior to the report, on 12May2021. The patient also had signs of facial pain and headache on 04Mar2021. Later on, physician added that fingers were also having cramps. The patient had cramping in her legs and her fingers were frozen. The physician had the patient do some blood work and CBC came back as normal (unspecified date in 2021). The patient came back today (14May2021) still with the symptoms. The patient notified her doctor, and the clinic. The patient is saying that everything started after the second dose of the vaccine. The patient had pain at her fingers. Her fingers were frozen and locked. The patient reported these symptoms. The symptoms are all still going on and worsened. The patient reported that right away the side effects started. It was shortly after the COVID vaccine at the site of injection. The patient did not report anything in observation but did get the symptoms that day. The patient applied heat and took Tylenol with no changes. She went to the clinic on 09Apr2021. Since then the symptoms worsened. The patient said she feels incapacitated. The doctor is concerned with this. It was escalated to her. The reporting physician doesn't know the seriousness. They may send the patient to the emergency room. Especially since the patient said it was worsening. In the patient's opinion the causality is because of the vaccine. The CBC and CMP were normal. Today (14May2021), they are going to repeat all the tests. They are going to run more test to see why she is having symptoms still. The patient has hypothyroidism (pre-existing condition). They are going to review that panel. They are going to do a rheumatoid factor, a C reactive protein, another CBC and CMP, and a PT/INR. They are also going to do an ultrasound of the patient's lower extremities and a CT scan of the patient's sinuses and brain. The patient was given Tylenol and Solu Medrol/Methyprednisolone. The physician spoke with her boss and was advised to ask if Pfizer had recommendations. She is asking if Pfizer had some guidance on this. It was not reported if a corrective treatment was received for the event nosebleed, while corrective treatment was applied for the remaining events. Outcome of the event nosebleed was unknown, while the outcome of the remaining events was not recovered.   No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on information available, a possible contribution role of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) to the onset of the reported events muscle cramps, musculoskeletal stiffness, joint lock and movement disorder cannot be completely excluded.  The case will be reassessed should additional information become available.  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.