Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic, Sleep disorder
Clinical narrative: fluid build up around her right lung and had 1 liter of fluid pulled off; trouble breathing; Itchy rash; pain in her right side; progressive weakening; to help her sleep; This spontaneous case was reported by a patient and describes the occurrence of PLEURAL EFFUSION (fluid build up around her right lung and had 1 liter of fluid pulled off), DYSPNOEA (trouble breathing), PAIN (pain in her right side), ASTHENIA (progressive weakening) and SLEEP DISORDER (to help her sleep) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003C21A and 002B21A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Pericardial effusion (The pericardial effusion was 3 years ago, prior to Ibrance,and as a result she had blood pressure issues. Her heart was squirting out fluid while she was jogging and she could feel it.) in 2018, Blood pressure abnormal (blood pressure issues for which she takes natural therapies to control; she prefers those to be vegetarian,they are ginseng, gingko biloba, licorice, tea tree oil, and yohimbe), Spinal cord injury, Hip injury, Pericardial effusion in 2019, Breathing difficult, Crawling sensation of skin, Pericardiocentesis (emergency pericardiocentesis) and Chemotherapy. Concurrent medical conditions included Metastatic breast cancer. Concomitant products included LICORICE [GLYCYRRHIZA GLABRA], GINSENG NOS, GINKGO BILOBA (GINGKO BILOBA), TEA TREE OIL and YOHIMBINE (YOHIMBE [YOHIMBINE]) for Blood pressure abnormal, PALBOCICLIB (IBRANCE) and ANASTROZOLE for Metastatic breast cancer, ESTROGENS CONJUGATED (PREMARIN) for an unknown indication.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-May-2021, the patient experienced DYSPNOEA (trouble breathing) and RASH PRURITIC (Itchy rash). In 2021, the patient experienced PAIN (pain in her right side), ASTHENIA (progressive weakening) and SLEEP DISORDER (to help her sleep). In September 2021, the patient experienced PLEURAL EFFUSION (fluid build up around her right lung and had 1 liter of fluid pulled off). The patient was treated with GABAPENTIN in 2021 for Pain and Sleep disturbed, at a dose of 2 dosage form as required; GINSENG NOS for Breathing difficult, at an unspecified dose and frequency; GINKGO BILOBA (GINGKO BILOBA) for Breathing difficult, at an unspecified dose and frequency; TEA TREE OIL for Itchy rash, at an unspecified dose and frequency and YOHIMBINE (YOHIMBE [YOHIMBINE]) for Breathing difficult, at an unspecified dose and frequency. On 31-May-2021, RASH PRURITIC (Itchy rash) had resolved. At the time of the report, PLEURAL EFFUSION (fluid build up around her right lung and had 1 liter of fluid pulled off) had resolved, DYSPNOEA (trouble breathing) and SLEEP DISORDER (to help her sleep) outcome was unknown, PAIN (pain in her right side) was resolving and ASTHENIA (progressive weakening) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In September 2021, Computerised tomogram: she had a little problem, it seems like the dye didn't leave her body..         She has an old high school spinal and hip injury, and after chemo it ate so much out of her that she can't run anymore like she used to, so she tries to walk as much as she can. Patient was taking Ibrance 75mg. She was taking Ibrance 125mg, but she had to decrease the dose because she had uncontrollable eye watering.  she started Ibrance about 2 years ago. She thinks she had just started taking the 2nd month when her dosage was decreased to 75mg. She thinks she only took about 1 week of the 2nd month at 125mg, then she had an appointment with the doctor and told him about the eye watering. After the dosage was decreased the eye watering stopped completely. States that she did not feel like she had any glaucoma starting. Her fear was that it would have brought on something like glaucoma or that it would start ripping her eye from the socket, but that never happened. Prior to Ibrance, She has had 2 rounds of chemo. Her 1st round of chemo had to be discontinued because the steroids she had to take with the chemo were too strong; no name for the steroids. She then switched Oncologists, and started a 2nd round of chemo. Stated that she was very sensitive to medications which was why she prefers the natural approach to therapy. This new group of doctors respects that. Since completing the 2nd round of chemo and starting the Ibrance she has had no new tumor growth, but after having the fluid drained from her right lung the doctor informed her that she still has cancer cells in the fluid. Caller states that she guessed the cancer cells are still floating around in her blood, but her kidneys, and liver are good. she was on chemo infusions for 1 year, then has been on Ibrance for 2 years. States she was on a partial round of chemo and she had a pericardial effusion. Her heart was squirting out fluid while she was jogging and she could feel it. Attempted to clarify details. stated that the 1st pericardial effusion was prior to her 1st round of chemo. She improved her heart condition before she started chemo, but had to stop the 1st round chemo because it was too strong. Stated that the oncologist said she had to stay on steroids for all the infusions. She had been on steroids for 4 of the infusions at that point and was going in every 2 weeks and she was starting to feel way too week. She told her oncologist that she wanted a month off so she could get some strength back, but she refused, so caller stopped going for chemo altogether. About a year later, she had a 2nd pericardial effusion. States that she couldn't breathe, so they did an emergency pericardiocentesis to drain the fluid from around her heart, and she had multiple drains coming out of her lungs. She lived and recovered and she started going to a new oncologist. He put her on a more mild chemo and she went for infusions every 3 weeks instead of every 2 weeks. Also, there was a medication that the first oncologist would attach to her arm, like an autoinjector, and she would get the medication the day after the infusion, but she hated it because it made her feel like she was crawling out of her skin. The new oncologist changed it to something milder and she goes into the office the next day to get the injection, and that has been helpful. Caller does not know the names of the chemo, steroids, or injection she receives after the chemo. Multiple attempts made to clarify details and timeline of events. Information is captured as provided  Patient stated that the breast cancer started on her left breast because she was poisoned from an extreme dose of Premarin. States that it blew a hole out of her left breast that would not fill itself. Caller stated that was a presumption because it's just consistent with other cases that her doctors have seen, but she has never been prescribed or taken Premarin before. Stated that her assumption is that a gallon of milk in a private residence was laced with Premarin, but she can't prove it. Her husband brought the gallon of milk home with him, and they both drank it, they even gave some to the dog. Soon after she was diagnosed with breast cancer, her husband was diagnosed with prostate cancer, and even her dog was diagnosed with cancer. Caller states that it blew a hole out of her breast and chest that would not fill itself and the pericardial effusion was squirting from her heart. Caller states that this may sound crazy, but she used a plastic type syringe and she boiled heavily salted water and she injected the salted water into the hole in her breast to clean it and help it heal. States that she found that it stopped the squirting in her heart. She thinks that the salted water stopped the pericardial effusion the 1st time, but when she started the 1st round of chemo and was on the steroids she was afraid that it would blow out her heart and her chest completely and the doctor wouldn't listen to her. So she stopped going for the infusions    This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in   Most recent FOLLOW-UP information incorporated above includes: On 07-Oct-2021: Live follow-up no new information received.