Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Mass, Pain, Peripheral swelling, Rash, Swelling
Clinical narrative: it was erythema nodosum; bump; rash which she later clarified as a bump appeared on her left leg after a week.; rash which she later clarified as a bump appeared on her left leg after a week.; has problems to walk and move because of the pain; She felt sick; felt like she had the flu; She felt weak; lethargic; Leg is swollen; she can't hold on to her feet; cellulitis; has problems to walk and move because of the pain; has problems to walk and move because of the pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (159558). The reporter is the patient.  A 57-year-old female patient received BNT162b2 (BNT162B2), on 07May2022 as dose 4 (booster), single (Lot number: FK9893) at the age of 57 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (ongoing), notes: Hypothyroidism doesn't have the exact time but was diagnosed years ago, maybe 3-5 years ago. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose 1, Single, NDC: unknown, Lot number: ER8733, Dose and Route: left arm), administration date: 31Mar2021, when the patient was 56-year-old, for COVID-19 immunization; BNT162b2 (Dose 2, Single, LOT: EW0170, Route: left arm), administration date: 20Apr2021, when the patient was 56-year-old, for COVID-19 immunization; BNT162b2 (Dose 3, Single, LOT: FF8839, Route: left arm), administration date: 19Nov2021, when the patient was 57-year-old, for COVID-19 immunization. The following information was reported: RASH (non-serious) with onset 12May2022, outcome "unknown", SWELLING (non-serious) with onset May2022, outcome "unknown" and all described as "rash which she later clarified as a bump appeared on her left leg after a week."; MALAISE (non-serious) with onset May2022, outcome "unknown", described as "She felt sick"; ASTHENIA (non-serious) with onset May2022, outcome "recovered" (Jun2022), described as "She felt weak"; INFLUENZA LIKE ILLNESS (non-serious) with onset May2022, outcome "unknown", described as "felt like she had the flu"; PAIN (non-serious) with onset May2022, outcome "unknown", GAIT DISTURBANCE (non-serious), HYPOKINESIA (non-serious) all with onset 2022, outcome "unknown" and all described as "has problems to walk and move because of the pain"; MASS (non-serious) with onset 31May2022, outcome "unknown", described as "bump"; PERIPHERAL SWELLING (non-serious) with onset 2022, outcome "unknown", described as "Leg is swollen"; CELLULITIS (medically significant) with onset 2022, outcome "unknown"; ERYTHEMA NODOSUM (non-serious) with onset Jun2022, outcome "unknown", described as "it was erythema nodosum"; LETHARGY (non-serious) with onset 2022, outcome "unknown", described as "lethargic"; LIMB DISCOMFORT (non-serious) with onset 2022, outcome "unknown", described as "she can't hold on to her feet". The events "cellulitis", "rash which she later clarified as a bump appeared on her left leg after a week.", "has problems to walk and move because of the pain", "she can't hold on to her feet", "bump", "it was erythema nodosum", "leg is swollen", "she felt sick", "felt like she had the flu", "she felt weak" and "lethargic" required physician office visit. The patient underwent the following laboratory tests and procedures: Blood test: (Jun2022) okay. Therapeutic measures were taken as a result of cellulitis, rash, swelling, mass, erythema nodosum.  Additional information: It was reported that caller stated that a rash which she had later clarified as a bump appeared on her left leg after a week. Caller stated that the bump has become bigger and has spread to her other leg. Caller went to an infectious disease doctor who said that it was a reaction to the Pfizer COVID-19 Vaccine. She wanted to know about the risk and damage to other parts of the body, since it has been a month with this problem. She used to be a very active person, but now has problems to walk and move because of the pain. She can't hold on to her feet for too many hours. She has 25 small bumps and 5 big bumps that are so painful. And the 1 bump close to her ankle is the most painful. There is a 1 bump coming to her left arm close to her elbow. Caller mentioned that her bloodwork is okay and is frustrated. Caller wanted to know if Pfizer can recommend any doctor for her. Caller also mentioned that she has called the CDC before who told her that they will send her an email which she has not received. It was reported that consumer on the other line that received fourth dose of Pfizer Covid19 vaccine. There are painful red dots on legs. She doesn't know what to do. Caller confirmed details provided by transfer agent. She received fourth dose on 07May2022. On 12May2022, a week later, she had rash on left leg. She didn't worry because she thought it was something with her pant. Went to the doctor and everything was fine. On Tuesday 31May2022 she started with a bump and was very painful. It was flat in the beginning on her shin on left leg. Then it became bigger the next week and painful and red and warm. Then she visited orthopedist who sent her antibiotics. She took the antibiotic for a week, and it got worse and worse. She made appointment with dermatologist and the dermatologist told her that it was erythema nodosum and told her to take anti-inflammatories. She finished anti-inflammatories and it got worse and spread to the other leg and it is bigger and very painful and red. She called back her primary care because they said it was cellulitis, but it wasn't. Primary care said it was an infection and go to infectious disease doctor. Made appointment and went to see infectious disease doctor and he said it is not an infection because her blood work comes back ok. Infectious disease doctor said it was pretty much a reaction to the vaccine. It is so painful, and caller doesn't know what to do. Leg is swollen even if she uses compression socks. She is a little concerned and wants to find a solution. Clarified that caller is looking for information about this type of reaction and what to do. Caller never had it before. She called her family and was asking and nobody in the family has this.   VACCINE SUPPLEMENTAL FORM:  Patient Details is available. Patient Age at Time of Vaccination was 57 years. Pfizer Suspect Vaccine and Vaccination Details. Vaccine Lot Number: FK9893. Vaccine Lot Expire Date: unknown. Time the Vaccination Was Given: not provided. Anatomical Location of Administration of Pfizer vaccine considered as suspect: left arm. : Vaccination Facility Type: Pharmacy. Vaccine Administered at a type of Facility was reported as no. Additional Vaccines Administered on Same Date of the Pfizer Suspect was none. Adverse Event (AE) Details was not provided. Did any AE(s) require a visit to: Emergency Room was She didn't go to the ER because she read that if she couldn't breathe go to emergency room. She felt sick and felt like she had the flu a couple of days before the bumps happened. She felt weak and lethargic because when she came back from work she wanted to sleep and do nothing. Throughout May, the whole month, and the beginning of June she felt weak. Physician Office was reported as yes. Prior Vaccinations (within 4 weeks) was none. AE(s) following prior vaccinations was she has felt tired with the other Pfizer COVID-19 Vaccines doses. She wanted to sleep. Patient's Medical History was hypothyroidism. Family Medical History Relevant to AE(s) was not provided. Relevant Tests was none. The anti-inflammatory was Naproxen 50mg, she threw the bottle out. She took two pills with meals every 12 hours. NDC/LOT/EXP: unknown. She only took a picture of the name of the medicine. Antibiotic was given to her by her primary care. The antibiotic was Doxycycline Hyclate 100mg. She has the pharmacy bottle. Use by 16May2023. Lot/NDC/EXP: unknown, it is a pharmacy bottle. Is there a product complaint to report was reported as yes. She had made appointment with dermatologist and the dermatologist told her that it was erythema nodosum and told her to take anti-inflammatories. She finished anti-inflammatories and it got worse and spread to the other leg and it is bigger and very painful and red. The anti-inflammatory was Naproxen 50mg, she threw the bottle out. She took two pills with meals every 12 hours. Product strength and count size dispensed was 50mg. She only took a picture of the name of the medicine. Is a sample of the product available to be returned. Packaging sealed and intact was not provided. It was reported that primary care said it was an infection and go to infectious disease doctor. Made appointment and went to see infectious disease doctor and he said it is not an infection because her blood work comes back ok. Infectious disease doctor said it was pretty much a reaction to the vaccine. She took the antibiotic for a week, and it got worse and worse. Antibiotic was given to her by her primary care. The antibiotic was Doxycycline Hyclate 100mg. She has the pharmacy bottle. Use by 16May2023. Is a sample of the product available to be returned was not provided. Packaging sealed and intact was not provided.  Follow-up attempts are completed. No further information is expected.