Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Inguinal mass, Lymphadenopathy, Ultrasound scan, Ultrasound testes
Clinical narrative: huge lump in the groin area on the left leg/Lump in lymph gland in groin in left leg; lymph node lump; felt really bad; exhausted; This is a spontaneous report received from a Consumer or other non HCP. Regulatory number: 1048451 (FDA).  A 23-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 07Nov2024 at 15:00 as dose 1, single (Batch/Lot number: unknown) at the age of 23 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Autism" (unspecified if ongoing), notes: with special needs; "Down's syndrome" (unspecified if ongoing); "Seizures" (unspecified if ongoing); "Heart Problems" (unspecified if ongoing), notes: Heart Problems Open heart surgery when patient was 3 months old. It was a complete AV canal repair; "Stomach" (unspecified if ongoing); "allergies" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "sick" (unspecified if ongoing), notes: for a long time when she was young but grew out of it; "compromised immune system" (unspecified if ongoing), notes: because of Patient was sick for a long time when she was young. Concomitant medication(s) included: PROZAC taken for anxiety (ongoing); KEPRA taken for seizure, start date: 2017 (ongoing); OMEPRAZOLE taken for abdominal discomfort, start date: 2017 (ongoing); CLARITIN [CLARITHROMYCIN] taken for hypersensitivity; VITAMIN D3. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Anatomical Location: Arm, Lot Number / Expiry Date: EN5318. It was really hard to tell if 3 or 7. No expiry date to provide.), administration date: 26Jan2021, when the patient was 19-year-old, for COVID-19 immunization; BNT162b2 (DOSE 2, SINGLE), administration date: 16Feb2021, when the patient was 19-year-old, for COVID-19 immunization; BNT162b2 (Lot: EL9262, DOSE 3 (BOOSTER), SINGLE), administration date: 24Feb2021, when the patient was 19-year-old, for COVID-19 immunization; BNT162b2 (Lot:FE3592, DOSE 4, SINGLE), administration date: 01Sep2021, when the patient was 19-year-old, for COVID-19 immunization; BNT162b2;BNT162b2 omi ba.4-5 (Lot: GJ6738, DOSE 5, SINGLE), administration date: 11Jan2023, when the patient was 21-year-old, for COVID-19 immunization; comirnaty omicron xbb.1.5 (Lot: HG4665, DOSE 6, SINGLE), administration date: 27Oct2023, when the patient was 22-year-old, for COVID-19 immunization. The following information was reported: INGUINAL MASS (hospitalization) with onset 07Nov2024 at 18:00, outcome "recovering", described as "huge lump in the groin area on the left leg/Lump in lymph gland in groin in left leg"; LYMPHADENOPATHY (hospitalization) with onset 07Nov2024 at 18:00, outcome "recovering", described as "lymph node lump"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "felt really bad"; FATIGUE (non-serious), outcome "unknown", described as "exhausted". The events "huge lump in the groin area on the left leg/lump in lymph gland in groin in left leg" and "lymph node lump" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: Biopsy: didn't look like cancer; Blood test: Normal; Body temperature: no temperature; Ultrasound scan: lump in the lymph node gland; Ultrasound testes: unknown results.  Clinical course: Caller calling in regards to the covid vaccine this year. Wanted to report granddaughter took vaccine and had adverse event. Got the shot at 3:00 in the afternoon and by 6:00 that afternoon when bathing saw she had a huge lump in the groin area on the left leg. It was huge 2.5 to 3 inches long, raised up really high. Like an inch high. It panicked us and took her the next day to urgent care. Doctor said oh my god, never seen anything like this. Said it was in her lymph node and to take her to the ER immediately. Left there and went to the ER at (withheld) in (withheld), maybe in (withheld) on highway I-10. Went to ER and they ran tests, all the blood tests. There was no temperature and all blood tests came back normal. Was told that the next step would be to get a biopsy and take her to her primary care doctor in 1 or 2 weeks and let take them take a look at it. Went to primary care and she was alarmed. Everybody was alarmed when they saw it. Said it didn't look like cancer because cancer is hard and this was soft, pliable. Caller told primary care doctor that the doctor at the ER told her the next step was biopsy. Primary care doctor said if it was sent to a surgeon, they would operate/remove it. Caller said no, wouldn't do surgery because granddaughter is prone to seizures. Was told if they did do that, they could wait. Caller's daughter looked it up on google and saw it was a side effect that can happen. It has gone down, it has taken 6 to 8 weeks, not sure if it is gone completely. If we had to have surgery, patient has down syndrome and is autistic and doesn't understand it. Caller needs to check lump tonight. Patient's mother bathes her since caller is 88. It has been there for a long time. Thinks it finally is going away but she is not sure if it has or not; moved from down her leg into her genitals then back down further and it was crazy and horrible. In the middle of leg, way down deep in there. If it is still there, will have to see another doctor. As of 17Mar2025, it was reported that the patient had a lump in lymph gland in groin in left leg appeared 3 hours after receiving Covid shot. Went to urgent care, ER and primary care doctor. Patient felt really bad and exhausted.   Follow-up (23Jan2025): Follow-up attempts are completed.  Amendment: This follow-up is being submitted to amend the previous reported information which includes: to remove lot number from suspect product.  Batch/lot number is not provided, and it cannot be obtained.  Follow-up (17Mar2025): This is a spontaneous follow-up report received from a same consumer. Updated information: New events added (felt really bad and exhausted), event verbatim subsumed.   The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.