Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram ambulatory, Endometriosis, Gluten sensitivity, Headache, Heart rate
Clinical narrative: oophorectomy; Numbness; Lymph node disorder; Breathing difficult; Ovarian chocolate cyst; Dysfunctional uterine bleeding; Suspected COVID-19; Anemia; Injection site pain; Endometriosis related pain; Coughing; Sore throat; Endometriosis; Oxygen saturation decreased; Dizzy; Shortness of breath; Blood pressure high; Heart rate increased; Muscle pain; Sore throat; Coughing; Ache; Shoulder blade pain; Chest tightness; Chest pain; Menstrual cycle abnormal; Headache; Injection site pain; Abdominal pain; Diarrhea; Pneumonia; COVID-19; Gluten sensitivity; Tachycardia; Cyst of ovary; Partial salpingectomy; Ventricular tachycardia; Dizziness; Palpitation; This is a spontaneous report based on information received by Pfizer from Regulatory Authority (Mfr. Control No.: 21K-163-4013002-00) via consumer (patient) who reported for herself.  A 42-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via intramuscular route of administration on 13Jul2021 (at the age of 42-years-old) (Batch/Lot number and expiration date were not reported) as dose 1, single, and dose 2 via intramuscular route of administration on 05Aug2021 (at the age of 42-years-old) (Batch/Lot number was not reported) as dose 2, single both takenfor Covid-19 prevention; leuprorelin acetate (LUPRON DEPOT) via intramuscular route of administration from 2015 (Batch/Lot number was not reported) to 2016, at unspecified dose for an unspecified indication; oxybate sodium (XYREM), via an unspecified route of administration from 2010 (Batch/Lot number was not reported) to an unspecified date, at unspecified dose for narcolepsy. Patient Medical history included Narcolepsy (Started 2010), Endometriosis (Started 2015), Ehlers-danlos syndrome, Migraine, Penicillin allergy, No tobacco, Abstains from alcohol, Penicillin allergy manifested by hive, Prozac allergy manifested by syncope, Wellbutrin allergy manifested by psychological reaction depression, Betadine allergy manifested by hives, Adhesive tapes allergy manifested by hives, Xyrem allergy manifested by shortness of breath, high blood pressure, high heart rate, weakness, Lexipro allergy manifested by swelling of hands, Lysteda allergy manifested by chest pain, Defaxine allergy manifested by hives, Monistat allergy manifested by swelling, Bactrim allergy manifested by hives, Mirena allergy manifested by pelvic pain and bruising in the leg, Lobster allergy manifested by anaphylaxis, Nickel allergy manifested by hives, Pneumonia, Asthma, Trouble Breathing, Dyspnoea, Allergy, Allergy, Allergy. The patient family history included patient's father had a history of hypertension. Concomitant medications included budesonide, formoterol fumarate (SYMBICORT "ASTRAZENECA") taken for pneumonia, start and stop date were not reported; fluticasone furoate, vilanterol trifenatate (BREO ELLIPTA) taken for asthma, start and stop date were not reported; oxymetazoline hydrochloride (CLARITIN ALLERGIC) taken for dyspnoea, hypersensitivity from Mar2020 to an unspecified stop date; budesonide (NASOCORT) taken for hypersensitivity, start and stop date were not reported; fluticasone propionate (FLONASE ALLERGY RELIEF) taken for hypersensitivity from Mar2020 to an unspecified stop date. The patient past medications included Monistat for unknown indication, Bactrim for unknown indication, Mirena for unknown indication, Defaxine for unknown indication, Lysteda for unknown indication, Lexipron for unknown indication, Betadine for unknown indication, Wellbutrin for unknown indication, Prozac for unknown indication. It was unknown if patient was enrolled in a COVID-19 vaccine trial. It was reported that the patient experienced events of left fallopian tube removed, node removed off from colon, left ovary removed, numbness on one side of body, unsustained ventricular tachycardia, trouble breathing with any physical activity, ventricular tachycardia, chocolate cyst on right ovary, blood pressure high, tachycardia, surgery to remove endometriosis and cyst on right ovary and non-serious coughing, increased heart rate, possible Covid-19, sore throat, bleeding and passing clots in endometriosis patient, pain in clavicle on top of shoulder, chest squeezing, pneumonia, oxygen saturation dropped, covid-19, hard time eating gluten and soy, moving or walking caused drop in oxygen saturation and made dizzy, chest pain, shortness of breath, abdominal pain, abdominal cramping with gluten and soy, recurred sore throat, diarrhea with gluten and soy, recurred cough, period had been crazy, tachycardia, anemia, pain in the muscle in chest, pain at the site of injections for hip pain, left arm injection pain, headache, aching, endometriosis pain, dizziness and palpitation with lupron depot (leuprolide acetate depot). The patient had a relevant medical history of endometriosis, migraine and patient's father had a history of hypertension. On unknown dates, the patient experienced left fallopian tube removed, node removed off from colon, numbness on one side of body, trouble breathing with any physical activity, surgery to remove endometriosis, cyst on right ovary, possible Covid-19, bleeding and passing clots in endometriosis patient, period had been crazy, anemia and pain at the site of injections for hip pain. In 2015, the patient experienced ventricular tachycardia, oxygen saturation dropped, dizziness and palpitation. In may2015, the patient experienced left ovary removed. In 2016, the patient experienced unsustained ventricular tachycardia, chocolate cyst on right ovary and tachycardia. In 2016, the dizziness and palpitation resolved. In 2020, the patient experienced pneumonia, covid-19, hard time eating gluten and soy, abdominal cramping with gluten and soy and diarrhea with gluten and soy. On 13Jul2021, the patient experienced chest pain, abdominal pain, recurred sore throat, left arm injection pain and headache. On 13Jul 2021, the headache resolved. On 14Jul 2021, the patient experienced coughing, sore throat, pain in clavicle on top of shoulder, chest squeezing, pain in the muscle in chest and aching. On 16Jul2021, the recurred sore throat resolved. On 18Jul2021, the patient experienced tachycardia. On 19Jul2021, the patient experienced increased heart rate. On 20Jul2021, the patient experienced blood pressure high and shortness of breath. On 21Jul2021, the patient experienced moving or walking caused drop in oxygen saturation and made dizzy. On 24Jul2021, the patient experienced endometriosis pain. In Jul2021, the sore throat and endometriosis pain resolved. On 06Aug2021, the patient experienced recurred sore throat and recurred cough. On 07Aug2021, the recurred sore throat and recurred cough resolved.in 2021, the coughing resolved. On unknown dates, unsustained ventricular tachycardia, tachycardia and period had been crazy resolved. Pfizer biontech covid-19 vaccine (tozinameran) and xyrem (oxybate sodium) were also considered suspect. The patient had chest pain and was wearing a halter monitor for 14 days, but they thought it was musculoskeletal. A week later, she had a heart rate go to 140-160 for a couple of days. The initial time it went to 160's for about two days and then it dropped to 140's. In 2015, she had unsustained ventricular tachycardia. This event was not nearly as bad as that one. That time, she was super dizzy and could feel palpitations. She had experienced drop in oxygen saturation to 70-80's when she was moving. When sitting, they were in the 90's and then it dropped to 70-80's. It had recovered completely when she would sit down and rest. She was not concerned because it was not sustained. Her period has been crazy also. She did MRI, CT, x-rays for a hospital and they required her to get it. She had been holding out to get COVID shot due to reactions to other medications. She had blood pressure that was stroke high, numbness on one side of body, trouble breathing with that. She was hospitalized for a few days. She had abdominal pain in the beginning. She does not have an ovary and fallopian tube on one side on left. Her ovary was removed may 2015. She could not recall her dose of lupron but mentioned that she could have taken it twice of the 3 month period and a dose for the one month period. She recovered from the tachycardia, palpitations an dizziness a couple of months after she stopped taking lupron. She had surgery to remove the endometriosis in 2016. It was an excision surgery to remove it. Over 20 spots on her such as ligaments, bladder, colon, that kind of thing. They did reconstruction because everything had adhered together and also had chocolate cyst on right ovary which they removed and tried to restructure that ovary. She was pretty sure she had Covid earlier, like the year before early on because she had all the symptoms. She was on inhaler. Symbicort was the first inhaler because she was having pneumonia including the tree and bud. All the lymph nodes were inflamed in her chest and lungs. She was on Symbicort for a while after she got sick in 2020. She said Symbicort did work and did not remember how long she was on it. She did not have a dose, lot or expiration. She was on it for 2-3 months, but then her symptoms improved and then a couple of months later, she started having trouble breathing again. They put her on brio. She started off on 100mcg/25mcg and it was not working, so they had to increase it and started feb2021. She would be willing to send a sample and it was sealed and intact. She was taking inhalers was long term COVID. She would have months where she was ok and then would have months of horrible migraines and trouble breathing. She had on inhaler and either takes nasacort or flonase. She would take one or the other, depending on which one she can get. She did not have allergy symptoms, but if she did not take claritin and one of the nose spray which would have more difficulty breathing. They want her to stay on it long term to make sure it was not allergies that are triggering shortness of breath. She did not receive the second dose. When she was moving or walking or walking stairs that impacted it. When she was staying still, she was ok. She had pain in the muscle in her chest. It was weird because she had pain in clavicle on top of shoulder. She had pain there and in left hip, but she guesses her point was that said it was a place where she previously had injections for hip pain. That day she could not even push the shopping cart. It would make it worse and she had to have her daughter do it. It did not normally hurt her and had been hurting since she got the covid vaccine. She does not know if it was inflamed or what. Their hospital requires them to get covid vaccine and she did not get it up until this point because of her reactions to previous medications. When she got the vaccine the headache got better. That was a benefit. She has not had a headache since then which was amazing for her. The day after she had coughing, sore throat and aching. It started on 14Jul2021 in the morning. Chest squeezing and shortness of breath were in the morning of 14Jul2021. It has definitely improved. She had an episode of tachycardia on 18Jul2021 and did not monitor it until 19Jul2021, when she realized it went into the 160's. Her blood pressure was also a little higher on 20Jul2021. It was 137/88. Her shortness of breath was not really bad and then on 21Jul2021 was when were dropped and she got dizzy and she checked it. She thought her heart rate was causing it. On 22Jul2021, she was passing clots and bleeding. Before the vaccine she had her period for a week. So, she had some clotting and spotting that night and the next day. Then that kind of ceased but was starting again 22Jul2021.up until now, she has been having another full period with clots and that kind of stuff. She does have a history of endometriosis but it had been under control. She had still had bleeding and passing clots. On 24Jul2021, she had intense endo pain. She would get short of breath with any physical activity. It gets improved compared to what it was on 21Jul2021 and 22Jul2021. She recently undergone echocardiogram and stress test with no significant finding. She also had holter monitor testing and blood tests which were still waiting for results. The patient underwent laboratory and other diagnostic tests which included blood tests: unknown on an unspecified date in 2021, computerised tomogram: not reported on an unknown date, echo: normal on an unspecified date in 2021, electrocardiogram: tachycardia on 15Jul2021, electrocardiogram: tachycardia on 27Jul2021, electrocardiogram: normal on 27Jul2021, halter monitor test: unknown on 27Jul2021, heart rate: went to 160 for about two days and then it dropped to 140 on 19Jul2021, heart rate: 70-80 s on an unknown date, magnetic resonance imaging: not reported on an unknown, oxygen saturation: dropped to 70-80's when she was moving.when sitting, they were in the 90's on an unspecified date in 2015, stress test: normal on an unspecified date in 2021, ultrasound (unspecified): normal on an unspecified date in 2021, x-ray: not reported on unknown date. The patient was treated with aspirin, atenolol and tylenol. The outcome of the events Partial salpingectomy, Left oophorectomy, Numbness, Lymph node disorder, Ovarian chocolate cyst, Cyst of ovary, Suspected COVID-19, Shoulder blade pain, Chest tightness, Pneumonia unknown, COVID-19, Oxygen saturation decreased, Dizzy, Anemia, Muscle pain, Injection site pain was unknown. The outcome for events Non-sustained ventricular tachycardia, Tachycardia was recovered on an unspecified date, Endometriosis was recovered on an unspecified date in Jul2021, for Sore throat was recovered on 07Aug2021, Coughing was recovered on an unspecified date in 2021, Menstrual cycle abnormal was recovered on an unspecified date in 2021, Headache was recovered 13Jul2021, Endometriosis related pain was recovered on an unspecified date in 2021, Dizziness was recovered on an unspecified date in 2016, Palpitation was recovered on an unspecified date in 2016, Sore throat was recovered on 21Jul2021, Coughing was recovered on an unspecified date in 2021, the outcome for events Breathing difficult, Heart rate increased, Chest pain, Shortness of breath, Abdominal pain, Injection site pain, Ache was recovering and the outcome for events Blood pressure high, Dysfunctional uterine bleeding, Gluten sensitivity, Diarrhea was not recovered.   Lupron depot: Causality: Non-sustained ventricular tachycardia: Causality as per reporter (Drug/Vaccine) : Probable, Blood pressure high: Causality as per reporter (Drug/Vaccine) : Not Related, Tachycardia: Causality as per reporter (Drug/Vaccine) : Probable, Heart rate increased (Heart rate increased): Causality as per reporter (Drug/Vaccine) : Not Related, Shortness of breath:Causality as per reporter (Drug/Vaccine) : Not Related, Abdominal pain: Causality as per reporter (Drug/Vaccine) : Not Related, Coughing: Causality as per reporter (Drug/Vaccine) : Not Related, Sore throat :Causality as per reporter (Drug/Vaccine) : Not Related, Sore throat: Causality as per reporter (Drug/Vaccine) : Not Related, Cough: Causality as per reporter (Drug/Vaccine) : Not Related, Muscle pain: Causality as per reporter (Drug/Vaccine) : Not Related, Injection site pain: Causality as per reporter (Drug/Vaccine) : Not Related, Dizziness: Causality as per reporter (Drug/Vaccine) : Probable, Palpitation: Causality as per reporter (Drug/Vaccine) : Probable.  BNT162B2: Causality: Heart rate increased: Causality as per reporter (Drug/Vaccine) : Probable, Shortness of breath: Causality as per reporter (Drug/Vaccine) : Probable, Abdominal pain: Causality as per reporter (Drug/Vaccine) : Probable, Sore throat (Oropharyngeal pain): Causality as per reporter (Drug/Vaccine) : Probable, Sore throat: Causality as per reporter (Drug/Vaccine) : Probable, Injection site pain: Causality as per reporter (Drug/Vaccine) : Probable, Dizziness:Causality as per reporter (Drug/Vaccine) : Not Related, Palpitation: Causality as per reporter (Drug/Vaccine) : Not Related.  Xyrem: Causality: Heart rate increased: Causality as per reporter (Drug/Vaccine): Probable.