Sex: F
Vaccine: COVID19
Symptoms: Axillary mass, Breast mass, Lymphadenitis, Thrombosis, Ultrasound scan
Clinical narrative: a huge lump the size of an avocado in her armpit and breast; a huge lump the size of an avocado in her armpit and breast; inflammation on her lymphatic system; she also broke out in hives; 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.  A female patient received BNT162b2 (BNT162B2), on 10Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "arthritis" (unspecified if ongoing); "Allergic to Sulfas" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Biaxin, reaction(s): "Known allergies: Biaxin". Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 Immunization, reaction(s): "cold chills"; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 Immunization, reaction(s): "her legs and feet swelled badly", "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". The following information was reported: AXILLARY MASS (non-serious), BREAST MASS (non-serious), outcome "unknown" and all described as "a huge lump the size of an avocado in her armpit and breast"; LYMPHADENITIS (non-serious), outcome "unknown", described as "inflammation on her lymphatic system"; URTICARIA (non-serious), outcome "unknown", described as "she also broke out in hives". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: It was reported that Caller wants 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 31Mar 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 30Jun, 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 10Dec 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 really 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 Progesteron 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. During the call she mentioned that her girlfriend (70 years) received the vaccine (did not specify the manufacturer) and got sick git COVID after that and she is really sick.  LAB-0519-6.0, Rev Sep2018, Estrogens should be used at the lowest dose possible for her treatment only as long as needed. she and her healthcare provider should talk regularly (for example, every 3 to 6 months) about the dose she was taking and whether she still need treatment with PREMARIN Vaginal Cream.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.