Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Ultrasound scan
Clinical narrative: her legs and feet swelled badly; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  An adult female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Arthritis" (unspecified if ongoing), notes: caller also has Arthritis; "sulfas" (unspecified if ongoing), notes: Sulfa. The patient's concomitant medications were not reported. Past drug history included: Biaxin, reaction(s): "tongue swells from it", notes: she is allergic to Biaxin (tongue swells from it  ); Estrace, reaction(s): "she got sick", notes: she had allergic reactions to all of them, including Estrace 0.1%, Mylan, Ativan (two different generics), she ended up having reactions to these medications and every time she used them she got sick.; Ativan, reaction(s): "she got sick", notes: Mylan, Ativan (two different generics), she ended up having reactions to these medications and every time she used them she got sick.; Poison ivy, reaction(s): "had a couple of episodes of skin reactions", notes: had a couple of episodes of skin reactions with poison ivy. Vaccination history included: Bnt162b2 (Dose1, Cold chills), for COVID-19 immunization, reaction(s): "Cold chills". The following information was reported: PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "her legs and feet swelled badly". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of peripheral swelling.  Additional information: Caller wanted to know what is the lower dose recommended for Premarin vaginal cream, for how many days would a patient be on this dose and for how long could a patient take the medication. She was prescribed with Premarin Vaginal cream 1g for 14 days and then every other 3 days (she first receive it as a sample of the medication and it is currently waiting for the prescription to be fulfilled), she believes that this is more than what it is required, she has experienced burning sensation in her genital area and has not been able to walk out due to the discomfort, she also experienced headache, high blood pressure and bloating, she used the medication last night, since March 31st she has had problems, she has been prescribed with four different antibiotics, she also had to use progesterone and her left tube bleed. She has not been able to go out for a month because of the pain. During the call she also mentioned that she received the Pfizer´s COVID-19 vaccine, with the first dose she experienced cold chills, with the second dose her legs and feet swelled badly and she was taken out of birth control she has not been in birth control since June 30th, she had Cortisone because of the swelling on her feet, they had to send her to the Hospital to get ultrasounds for her feet and legs because of possible blood "BBTs" and white clots that came negative, when she received the third dose on December 10th of the vaccine she developed a huge lump the size of an avocado in her armpit and breast, she had this lump scanned with an ultrasound, her physician indicated that this could be due to an inflammation on her lymphatic system, she still has a "residual lump", she also broke out in hives (that felt hot) and had an alteration on her period and she was on her pills when she received the second dose, she is scared to get her second booster because she is unsure how she would react to it. Caller also stated to be tired and yawned a few times as she was unable to sleep due to the discomfort caused by the AEs and the pain "in her crotch". Caller also has arthritis; she is allergic to Biaxin (her tongue swells from it) and Sulfas. Before using Premarin she used different medications and she had allergic reactions to all of them, including Estrace 0.1%, Mylan, Ativan (two different generics), she ended up having reactions to these medications and every time she used them, she got sick. Her skin is sensitive overall and reacts to the seizing that they put in clothing developing eczema, she also had a couple of episodes of skin reactions with poison ivy. Patient used to take Flagyl and Diflucan and she experienced "horrific pain" and could not bend over she thought she had a bladder infection and vaginal dryness. She had to take Progesterone for 28-30 days, later she used Macrobid and still got the cold chills, she was then switched to Ciprofloxacin, and she is better now. She has been on Estrace since 2016. Caller does not believe that she will be using Premarin vaginal cream because of this, during the call she mentioned that she might get an infection for using the applicator and even though it can be washed it´s "disgusting". She used her syringes from her "old doses" to apply the product and the syringe didn´t even have a calibration for 0.5, she didn´t use the applicators from Pfizer that came with the box. She believes that the sulfate that is part of the formulation causes her burning. During her life she also presented allergies towards seven different types of antibiotics.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.