Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Drug hypersensitivity, Dyspepsia, Flatulence, Headache
Clinical narrative: Was so achy; headaches; threw up; Allergies; Sick to stomach; Gas; indigestion; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): EC-2023-149448 (RA).  An elderly female patient received bnt162b2 (BNT162B2 NOS), on 16Oct2023 as dose number unknown, single (Batch/Lot number: unknown) for COVID-19 immunisation; lenvatinib mesilate (LENVIMA), since 21Sep2023 (Batch/Lot number: unknown) at 20 mg daily; amlodipine (AMLODIPINE), first regimen since 12Oct2023 (Batch/Lot number: unknown) at 2.5 mg daily and second regimen since 25Oct2023 (Batch/Lot number: unknown) at 5 mg daily, all unknown for blood pressure increased. The patient's relevant medical history included: "Blood pressure increased" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Keytruda for C54.1: Malignant neoplasm of endometrium. The following information was reported: DRUG HYPERSENSITIVITY (non-serious) with onset Oct2023, outcome "unknown", described as "Allergies"; FLATULENCE (non-serious) with onset Oct2023, outcome "unknown", described as "Gas"; NAUSEA (non-serious) with onset Oct2023, outcome "unknown", described as "Sick to stomach"; DYSPEPSIA (non-serious) with onset Oct2023, outcome "unknown", described as "indigestion"; PAIN (non-serious) with onset 16Oct2023, outcome "recovered" (17Oct2023), described as "Was so achy"; HEADACHE (non-serious) with onset 16Oct2023, outcome "recovered" (17Oct2023), described as "headaches"; VOMITING (non-serious) with onset 16Oct2023, outcome "recovered" (17Oct2023), described as "threw up". Relevant laboratory tests and procedures are available in the appropriate section. The action taken for lenvatinib mesilate and amlodipine was unknown. Additional information: The patient reported being sick to stomach, gas, indigestion, and was not sure if it's related to her amlodipine, or Lenvima, or both. The cause was unknown but occurred while on Lenvima. Event started sometime in Oct2023. The patient also reported she received a COVID shot on 16Oct2023 and said she was so achy, with headaches, and thew up for about 24 hours after getting the COVID shot. The patient said this was resolved and thinks this event was related to the COVID shot but it also occurred while she was on Lenvima. The event started on 16Oct2023 and ended 17Oct2023. The patient also reported that she still has headaches. She also has allergies, so she not sure if the headaches are from Lenvima or her seasonal allergies. The cause was unknown but occurred while on Lenvima. The event started in Oct2023. The patient reported she was also put on Amlodipine 2.5 milligrams daily, which started around 12Oct2023, but she is now on Amlodipine 5 milligrams daily since 25Oct2023.Her blood pressure is now "down to 157" after a couple days of having her Amlodipine dose doubled. The cause was thought to be related to Lenvima and occurred while on Lenvima. The event started in Oct2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.