Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Spinal stenosis, Weight, Weight increased
Clinical narrative: SHE DID GAIN SOME WEIGHT; SPINAL STENOSIS GETTING WORST; SPINAL STENOSIS GETTING WORST; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from License Party. Other Case identifier(s): US-MMM-JKZQDIOR, US-BRISTOL-MYERS SQUIBB COMPANY-BMS-2021-092285.  An 81-year-old female patient received bnt162b2 (BNT162B2), on 28Feb2021 as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; apixaban (ELIQUIS), first regimen from Aug2020, Expiration Date: Dec2024 to 01Jan2021 and second regimen since 01Jan2021 (ongoing), Expiration Date: Dec2024 at 2.5 mg 2x/day (2.5 milligram, bid), all oral for thrombosis. The patient's relevant medical history included: "Flu" (unspecified if ongoing), notes: once at 21 years old; "Covid-19 Immunization" (unspecified if ongoing); "Injection site swelling" (unknown if ongoing); "Wheelchair user" (unknown if ongoing); "Lymphedema" (unknown if ongoing); "Spinal stenosis" (unknown if ongoing); "Sickness" (unknown if ongoing). The patient's concomitant medications were not reported. Past drug history included: Aspirin [acetylsalicylic acid]; Influenza vaccine for Flu, reaction(s): "Sickness". The following information was reported: SPINAL STENOSIS (non-serious), CONDITION AGGRAVATED (non-serious) all with onset Mar2021, outcome "not recovered" and all described as "SPINAL STENOSIS GETTING WORST"; WEIGHT INCREASED (non-serious), outcome "unknown", described as "SHE DID GAIN SOME WEIGHT". Relevant laboratory tests and procedures are available in the appropriate section. The action taken for apixaban was dosage not changed. Therapeutic measures were taken as a result of spinal stenosis, condition aggravated. The clinical course was reported as follows: this case was received via Pfizer Inc (Reference number: 202101183597) on 09-Sep-2021 and was forwarded to company on 10-Sep-2021. This spontaneous case was reported by a consumer and describes the occurrence of weight increased (she did gain some weight) in 81-year-old female patient who received apixaban (Eliquis) for an unknown indication. The patient's past medical history included Flu (once at 21 years old). Previously administered products included for product used for unknown indication: flu shot (She said that she got sick from the first flu shot that she took a couple of years ago. She got a flu shot and her legs started swelling and that was a year ago in August) and aspirin. Past adverse reactions to the above products included feeling unwell with flu shot. In August 2020, the patient started Eliquis (oral) 5 milligram at an unspecified frequency. On 01-Jan-2021, the dose was changed to 2.5 milligram twice a day. On an unknown date, the patient experienced weight increased (she did gain some weight). The dose of Eliquis (oral) was not changed. At the time of the report, weight increased outcome was unknown. For Eliquis (oral), the reporter did not provide any causality assessments. The reporter stated that she had the first dose of the vaccine in February and ever since she had it, she can't get around like she used to. She has trouble getting around. She takes Eliquis, and said that it works. It is a miracle. Weight: She stated that she did gain some weight. She said that she got a flu shot and her legs started swelling and that was a year ago in August and that is when she started having to take Eliquis. It was freezing cold when she went and got the Covid-19 vaccine. She said that it is just so distressing that she can't get around. She was not able to get around after a couple of weeks after receiving the vaccine. She does not want to get the other dose of the vaccine because she is afraid it will get worse. It was at the end of Feb-2021 when she received her Covid-19 vaccine. She said that she used to be able to take aspirin, but she cannot take it anymore.  Apixaban is under agreement with company.  Follow-up (31Oct2023): This is a spontaneous follow-up report received from contactable reporter(s) (Consumer or other non HCP) from License Party. Other Case identifier(s): US-MMM-JKZQDIOR, US-BRISTOL-MYERS SQUIBB COMPANY-BMS-2021-092285.  Supplement information was received from patient on 31-Oct-2023 with following updates: Product attribute were updated-Suspect product APIXABAN indication Blood clot, Suspect product PFIZER BIONTECH COVID-19 VACCINE (Solution for injection) (from 28-Feb-2021) for COVID-19 VACCINATION, lot number: Unknown. Medical history were added: Medical history and concurrent conditions included  injection site swelling, wheelchair user, lymphedema, spinal stenosis and sickness. Past therapies were added: INFLUENZA VACCINE and ASPIRIN [ACETYLSALICYLIC ACID].  New events were added: In Mar-2021, the patient had spinal stenosis (spinal stenosis getting worst), which was considered non-serious. Treatment included wheelchair. The spinal stenosis had not yet resolved. In Mar-2021, the patient had condition aggravated (spinal stenosis getting worst), which was considered non-serious. Treatment included wheelchair. The condition aggravated had not yet resolved.  Eliquis is under agreement with company.