Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Culture urine negative, Fatigue, Pain in extremity, SARS-CoV-2 test, Urine analysis
Clinical narrative: tiredness; sore arm for couple of days/arm was a little sore; This is a spontaneous report from a contactable consumer (patient). A 54-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: EN6207), dose 1 via an unspecified route of administration, administered in Arm Left on 18Mar2021 at 17:00 (at the age of 54-years-old) as a dose 1, single for covid-19 immunisation (Want to get back to some kind of life). Medical history included lupus nephritis, hiatus hernia and drug hypersensitivity. Reporter reported that she was diagnosed with Lupus when she was 32 years old, 22-24 years ago, which was Ongoing. Allergic to Lisinopril she had an allergic reaction to Lisinopril that caused her tongue and throat to swell.  Reporter reported that she was hospitalized for 3 days and intubated following her allergic reaction to Lisinopril which was Ongoing. she had the allergic reaction to Lisinopril years ago and is unable to provide product details.  Reporter reported that she was taking a small dose, she thinks 5 mg, and had been taking it for years when all the sudden she had an allergic reaction. Reporter reported that she was having issues with reflux and went for an endoscopy.  Reporter reported that the hiatal hernia was found about a year ago, which was Ongoing. Concomitant medications included mycophenolate mofetil (MYCOPHENOLATE) for Lupus Reporter reported that she began taking Mycophenolate 5-6 years ago. She takes 1000 mg in the morning and 500 mg at night, Which was ongoing. hydroxychloroquine sulfate (HYDROXYCHLOROQUINE ACTAVIS) for Lupus, Reporter reported that she began taking hydroxychloroquine decades ago.  Reporter reported that she takes 200 mg in the morning and 200 mg at night, which was ongoing. verapamil (VERAPAMIL) for Kidneys, which was ongoing. losartan (LOSARTAN) Reporter reported that she has been taking Losartan for at least 7 years, for Kidneys , Which was ongoing. pantoprazole (PANTOPRAZOLE) Reporter reported that she began taking Pantoprazole about a year ago, which was ongoing. Sertraline hydrochloride (ZOLOFT ODT), she began taking Zoloft about a year ago, for Problems with menopause which was ongoing. Additional Vaccines Administered on Same Date of the Pfizer Suspect was None. Prior Vaccinations (within 4 weeks) was none. AEs following prior vaccinations were A little soreness with flu vaccine. she has previously experienced a little soreness with the flu vaccine.  Reporter unable to provide adverse event or product details. Family Medical History Relevant to the event were none. The patient experienced sore arm for couple of days/arm was a little sore on 18Mar2021and tiredness on 19Mar2021. patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: EW0153), dose 2 via an unspecified route of administration, administered in Arm Left on 06Apr2021 as a DOSE 2, SINGLE for covid-19 immunisation. It was reported that, post 2nd dose of vaccination on 6Apr2021, 5 pm, patient was exhausted, nausea headache, muscle ache and joint ache. On the April 7 pm she had exhaustion and on April 8, 1 diarrhea that was resolved immediately. and then came back again after 2 weeks 26Apr2021, feeling exhausted, nausea, felt having UTI  that lasted about 10 days.  She reported that she was taking mycophenolate alongside getting the vaccine. She read that taking medications that suppresses the immune system may actually have a lowering response effect alongside getting the vaccine.  Given that her daughter is gonna have her wedding, she wanted to know if there is a specific test that can be done to check the efficacy of the vaccine (given she was taking immunosuppressant). Alongside with this, she would like to know if she may wear mask and take pictures on her daughter's wedding (considering that she has a family full of Anti-vaxxers). Reporter reported that she has Lupus, got the second dose of the Pfizer Covid-19 vaccine on 07Apr2021, and is taking immunosuppressant therapy. She has been plagued with a lot of the symptoms that come with the Covid-19 vaccine including headache, nausea, joint pain, and tiredness. Reporter reported that her Lupus has been in remission for a while and that she takes Mycophenolate for Lupus Nephritis. When she had her first dose of the Covid-19 vaccine she was fine.  Reporter stated she was just a little tired the next day and her arm was a little sore, nothing major. She received the second dose of the Covid-19 vaccine at 5:00 PM on 06Apr2021. Reporter reported that she made sure that she drank a lot of water that day and didn't pre-medicate before receiving the Covid-19 vaccine.  Reporter reported that she felt ok the night of 06Apr2021 and during the day on 07Apr2021. Reporter reported that around 8:00 PM on 07Apr2021, she hit the wall.  Reporter reported that she was exhausted, had a massive headache, muscle aches, joint aches, and extreme fatigue.  Reporter reported that she drank some more fluids and went to bed. she woke up the next morning on 08Apr2021, had one bout of bad diarrhea, and then all the sudden all of her symptoms were gone.  Reporter reported that she then felt fine until 26Apr2021. on 26Apr2021, her symptoms returned.  Reporter reported that she felt exhausted tired, nauseous, and weak.  Reporter reported that she let it go for 3-4 days then called her rheumatologist to inform them that something is off and she is not feeling good.  Reporter reported that she thought that she was having a flare of her Lupus. her rheumatologist ordered a bunch of blood work.  Reporter reported that the labs came back showing that her kidney filtration was less than stable and her white blood cells were up a little bit. Her rheumatologist ordered a urine test. Reporter reported that she called her nephrologist who stated that the reporter could have a UTI or kidney infection.  Reporter reported that her nephrologist got her started on Cipro until the urine culture came back. The urine culture came back negative, but it was a good 10 days to 2 weeks that she felt lousy.  Reporter reported that she finished the Cipro even though she didn't have a UTI.  Reporter reported that her nausea, headache, feeling of weakness, and exhaustion then went away. she was just wondering if because she is taking Mycophenolate and it suppresses the immune system that it just took longer for the Covid-19 vaccine to work for her. she is wanting to know what her immunity percentage is or how the Covid-19 vaccine will work since she's taking immunosuppressant medications. she had been doing research and noticed that her medication, Mycophenolate, is listed as having the possibility of causing a lower efficiency rate for the Covid-19 vaccine.  Reporter inquired if there is a test that can be done or ordered to check her immunity levels. She read something about stackable protein being checked. Her daughter is getting married at the end of Jul2021 and everything is opening up.  Reporter reported that she has a few friends and family members that don't trust science and refuse to get the Covid-19 vaccine.  Reporter stated that she is just afraid that being on the Mycophenolate affected the efficacy of the Covid-19 vaccine. she felt a little tired for 10 hours or so on 19Mar2021. her arm was a little sore for a couple of days following the Covid-19 vaccine. all of her doctors strongly recommended that she get the Covid-19 vaccine with her health issues. Reporter reported that her daughter is 27 and the only time the reporter has been off Hydroxychloroquine was 3 months before and while pregnant with her daughter. she takes the blood pressure medications Verapamil and Losartan not because she has high blood pressure but for her kidneys because of the Lupus Nephritis. Reporter reported that she has taken Verapamil since she was switched from Lisinopril.  she was having problems with menopause and her gynecologist suggested that sometimes Zoloft can help with hot flashes and things like that. she sometimes takes a multi vitamin, vitamin D, and vitamin C. Her rheumatologist ordered a bunch of blood work.  Reporter reported that the labs came back showing that her kidney filtration was less than stable and her white blood cells were up a little bit.  she was tested for Covid-19 before going to the gynecologist.  Reporter reported that she has been tested for Covid-19 multiple times because of the joint aches, headaches, and muscle aches that her Lupus can cause. The patient underwent lab tests and procedures which included culture urine negative which was negative on an unspecified date, urine analysis 03May2021, culture urine negative which was negative on 07May2021 Negative, sars-cov-2 test that was negative on an unspecified date Negative, urine analysis; white blood cells on an unspecified date, White blood cells - 2, urine analysis white blood cells-over 30 on 07May2021, White blood cells was over 30. Patient had Covid-19 Rapid test on 10May2021 that was Negative. Reporter seriousness for the events were Unspecified. Outcome of the events a little tired was recovered on 19Mar2021 and Arm was a little sore on Mar2021.    Information on Lot/Batch number was available. Additional information has been requested.