Pfizer

Life threatening symptom reports

Female, 26 - 39 years

Age Reported Symptoms Notes
26 2021-01-25 vaginal haemorrhage G2P0, 5w5d; The patient is calling with vaginal bleeding in pregnancy. Calling with c/o dizziness ... Read more
G2P0, 5w5d; The patient is calling with vaginal bleeding in pregnancy. Calling with c/o dizziness with headache; Has a history of migraines; States she has subclinical hypothyroidism. Has tried Tylenol 500 mg for headache that worked for a little while; She denies vomiting, but does have nausea; Will try to increase water and protein intake; Will let us know if she gets worse/vision changes and will check in with PCP as they wanted to do a VV if dizziness got worse. Bleeding continued into following day. Documented as likely / threatened miscarriage.
26 2021-02-22 anaphylactic reaction Anaphylaxis - tachycardia, palpitations, shortness of breath, skin itching. Received epi pen and ER ... Read more
Anaphylaxis - tachycardia, palpitations, shortness of breath, skin itching. Received epi pen and ER transport. Now undergoing allergy testing.
26 2021-02-24 grand mal seizure Patient presented for second dose of covid vaccine. She was administered Pfizer vaccine. Patient fai... Read more
Patient presented for second dose of covid vaccine. She was administered Pfizer vaccine. Patient fainted approximately 1 minute after administration of vaccine. Started as syncopal episode then patient started seizing - tonic/clonic. Patient was still seated in chair and seizing lasted about 1 minutes. 911 called. BP 138/78. P 115. Patient moved to cot after she was alert and oriented. By the time paramedics arrived patient was awake and oriented. She refused transport by EMS. She left with fiancé who was driving patient.
26 2021-03-02 anaphylactic reaction Slight anaphylactic reaction, not severe. Phlegmy throat, tight throat
26 2021-03-22 anaphylactic reaction Pt received the pfizer vaccine and pt had an anaphylactic reaction. Pt was given epinephrine x2 and ... Read more
Pt received the pfizer vaccine and pt had an anaphylactic reaction. Pt was given epinephrine x2 and Benadryl to take at home. Pt was seen in urgent care with me and given solumderol inj, medrol dose pack and hydroxyzine.
26 2021-03-24 vaginal haemorrhage Unexplained vaginal bleeding. I do not ever bleed. I?ve been in birth control since 17 and no bleedi... Read more
Unexplained vaginal bleeding. I do not ever bleed. I?ve been in birth control since 17 and no bleeding past my 20s aside from postpartum month (yes I got pregnant on the very first ovulation after I came off birth control and went back on after my baby) nothing has changed in diet or stress as I?m chronically ill and am used to being home and mask wearing.
26 2021-04-13 low platelet count Thrombocytopenia and severe abdominal pain concerning for thrombotic thrombocytopenic purpura.
26 2021-04-19 deep vein blood clot Acute DVT of the left lower extremity extending from the proximal femoral vein and proximal deep fem... Read more
Acute DVT of the left lower extremity extending from the proximal femoral vein and proximal deep femoral vein to the popliteal vein and into the gastrocnemius veins.
26 2021-04-21 vaginal haemorrhage 4/6/2021 vaccination Light cramping. I took my son on our daily walk. When going downhill, abd pain ... Read more
4/6/2021 vaccination Light cramping. I took my son on our daily walk. When going downhill, abd pain more intense pain. When I came home, I was seeing the brown spotting. Pelvic rest for 1 week per PCM. 4/22/2021I woke up today, bright red spotting. *Second pregnancy. 1st pregnancy, full term no complications. EDD; 12/16/2021. **PCM; checking in with clinic in an hour due to the bright red bleeding.
26 2021-04-25 cerebrovascular accident CVA/Embolic Stroke (I am prepared to give all medical records when needed)
26 2021-04-26 anaphylactic reaction Anaphylaxis -- outcome of event unknown
26 2021-04-28 blood clot The day after receiving the first dose of the Pfizer COVID-19 vaccine, the patient began to experien... Read more
The day after receiving the first dose of the Pfizer COVID-19 vaccine, the patient began to experience heavier than normal menstrual blood loss and blood clots. The patient returned in 21 days and received her 2nd dose of the vaccine and began to experience heavy clots and blood loss again along with headaches, paleness, and weakness. The patient saw a physician and was given medroxyprogesterone to decrease the bleeding on 4/15/2021. On 4/28/2021 the patient reported to an ER and was given a transfusion due to low iron levels.
26 2021-05-12 blood clot I got my period and released a blood clot the size of a large date. I typically release very small... Read more
I got my period and released a blood clot the size of a large date. I typically release very small blood clots during my period but never the size of the what I released yesterday
26 2021-05-16 anaphylactic reaction Anaphylaxis 2 hours after vaccine. Extreme swelling/tightening of throat, difficulty breathing, talk... Read more
Anaphylaxis 2 hours after vaccine. Extreme swelling/tightening of throat, difficulty breathing, talking, dizziness and feeling faint, spots in vision, choking, coughing, chest tightness.
26 2021-05-23 vaginal haemorrhage I experienced abnormal vagina bleeding outside of my regular monthly menstrual cycle following the v... Read more
I experienced abnormal vagina bleeding outside of my regular monthly menstrual cycle following the vaccination for 4 days from 5/20-5/23.
26 2021-05-28 vaginal haemorrhage Spotting/bleeding two weeks into the first shot; This is a spontaneous report from a contactable con... Read more
Spotting/bleeding two weeks into the first shot; This is a spontaneous report from a contactable consumer. A 26-year-old female patient received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Right Arm on 22Apr2021 17:00 (Lot Number: En0172) as 1ST DOSE, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Prior to vaccination, the patient has not been diagnosed with COVID-19 On 08May2021, patient experienced spotting/bleeding two weeks into the first shot. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the event was unknown. No treatment was received. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
26 2021-06-01 pulmonary embolism States received first covid vaccine early 4/2021 and soon afterwards developed chest pain. She went ... Read more
States received first covid vaccine early 4/2021 and soon afterwards developed chest pain. She went to her PCP at that time and he treated her for possible anxiety related to insomnia. She went to ER on 5/5/21 with negative workup and was told that it was likely anxiety related. She presented to my office on 6/1/21 for second opinion for continued chest pain. CT PE study was done finding multiple PEs.
26 2021-06-03 bleeding on surface of brain Patient presented to the ED on 5/1/2021 with subarachnoid hemorrhage and was subsequently hospitaliz... Read more
Patient presented to the ED on 5/1/2021 with subarachnoid hemorrhage and was subsequently hospitalized. This was within 6 weeks of receiving COVID vaccination.
26 2021-06-06 blood clot in the pt's words received my 1st (5/5/21) and 2nd (5/26/21) doses of Pfizer at County Fairgrounds. ... Read more
in the pt's words received my 1st (5/5/21) and 2nd (5/26/21) doses of Pfizer at County Fairgrounds. I want to document my experience as I had some pretty severe reactions to my second dose. Evening of the 26th I got chills and a fever of 102.9F. I took one ibuprofen and the fever went away. The next morning I had a slight headache. Around noon I got intense chest pains/pressure that lasted 30 minutes. I could not take a full breath as it was very painful. On the 28th, I woke up with a terrible headache for no apparent reason. Some ibuprofen helped. After a few hours it was gone. At 2am on the 29th, I woke up with very intense stomach cramps. I went to the bathroom and was able to pass out some stool over the course of about 30 minutes in the bathroom, and the cramps went away. On May 31st, I got what seemed to be a blood clot in my left index finger. It went away after about 20 minutes but still felt sore the rest of the day.
26 2021-06-07 excessive bleeding, vaginal haemorrhage bleeding; Vaginal spotting and some discomfort (cramping); Vaginal spotting and some discomfort (cra... Read more
bleeding; Vaginal spotting and some discomfort (cramping); Vaginal spotting and some discomfort (cramping); Vaginal spotting and some discomfort (cramping); This is a spontaneous report from a contactable consumer (patient). A 26-years-old female patient (not pregnant) received bnt162b2, dose 1 via an unspecified route of administration on Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization at the age of 26 years old. The patient received bnt162b2, dose 2 via an unspecified route of administration on 19Apr2021 13:00 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization The patient medical history was not reported. No known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication(s) included drospirenone, ethinylestradiol betadex clathrate (YAZ) taken for birth control. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced bleeding, vaginal spotting and some discomfort (cramping) on 05Apr2021. Reported as: Vaginal spotting and some discomfort (cramping). Its has been occurring since the fist dose in March. I am on the birth control Yaz but I am regular with taking it and it has been the same birth control for over a year. I have not had regular spotting before and I went to an OBGYN on 5/12 and there were no abnormalities that would indicate another cause of the bleeding. It's not serious but I'm reporting in the hope that your studies begin including effects on things like menstrual cycle because it sounds like there are effects like this happening.The adverse event result Doctor or other healthcare professional office/clinic visit. No treatment received. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was not recovered. Information about lot/batch number cannot be obtained. No further information expected.
26 2021-06-25 grand mal seizure Increased seizure activity and tonic-clonic seizure following injection.
26 2021-07-01 anaphylactic reaction Approximately 15 minutes post vaccination, patient started to show signs of anaphylactic reaction. P... Read more
Approximately 15 minutes post vaccination, patient started to show signs of anaphylactic reaction. Patient stated to the interpreter that her tongue was swelling and her throat was starting to close up. I administered 1 injection of Epi Pen to her left thigh. We summoned the resident RN on site. A pulse oximeter was placed on her left hand. She was administered oxygen via nasal cannula. I called 911 from my cell phone. Paramedics arrived on site in about 5 minutes. The paramedics made the decision to transport her to the local hospital
26 2021-07-01 atrial fibrillation Near syncope following vaccination followed by 2 days of HA, elevated HR and blurry vision. March 8t... Read more
Near syncope following vaccination followed by 2 days of HA, elevated HR and blurry vision. March 8th, symptoms worsened. Went to ED and was told she had a fib. 3/25- reported to clinic for continued fevers, blurry vision, poor appetite, HA, dizziness, body aches and increased HR. Returned to clinic on 3/29, 4/8 and 4/15 with a similar constellation of symptoms. 5/11- seen in the ED for migraine. 5/12- Seen again in the clinic with autoimmune panel run. Seen again on 5/17 in the clinic and in the ED on 5/30 for ongoing tachycardia and dizziness that worsens throughout the day. Additional neuro and cardiology work ups requested.
26 2021-07-13 death The first dose of vaccine (lot number EW0176) was taken on 05/06/2021, and the second dose of vaccin... Read more
The first dose of vaccine (lot number EW0176) was taken on 05/06/2021, and the second dose of vaccine (lot number EW0186) was taken on 05/27/2021. within 12 hours of second does she had gotten severe headache, she couldn't eat for severe vomiting, she said she felt like she was hit by a truck, and had the chills. she would go from really cold to really hot. She couldn't keep anything down even water. On the third day after the vaccine she was very sick and we ( the family) thought she was sleeping but when we went to try and wake her up we discovered her dead.
26 2021-07-22 cardiac arrest rapid heart beat
26 2021-07-22 grand mal seizure Increase in Tonic Clonic seizures,; A total of 6 seizures which are ongoing to this day; This is a s... Read more
Increase in Tonic Clonic seizures,; A total of 6 seizures which are ongoing to this day; This is a spontaneous report from a contactable consumer (patient herself). A 26-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection Lot number: EW0175, Expiration Date was not reported), via an unspecified route of administration in right arm on 29Apr2021 11:15 (at the age of 26-years-old) as dose 1, single for COVID-19 immunisation. The patient medical history included epilepsy, ADHD. Concomitant medication included zonisamide, methylphenidate hydrochloride (CONCERTA), folic acid (FOLIC), all taken for unknown indications from an unknown date. Other medications received in two weeks included Kelnor birth control. The patient previously took celontin and experienced drug hypersensitivity. No other vaccine received in fou rweeks. Patient had not been diagnosed with COVID-19 prior to vaccination and had not tested for COVID-19 since the vaccination. On 29Apr2021 03:00 PM, the patient experienced increase in tonic clonic seizures, A total of 6 seizures which are ongoing to this day. Treatment was received for the events. Adverse event treatment includes rescue medication. The outcome of the events was unknown.
26 2021-07-29 heart attack her heart is racing and feels like it is going to beat out of her chest. Her nerves are so bad right... Read more
her heart is racing and feels like it is going to beat out of her chest. Her nerves are so bad right now she is about to have a heart attack; weird bumps, explained as one red spot in right upper arm; weird bumps, explained as one red spot in right upper arm; Her nerves are so bad; This is a spontaneous report from a contactable consumer (patient). A 26-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: FA6780) via an unspecified route of administration in right upper arm on 15Jul2021 at around 09:00 (at the age of 26-year-old) as DOSE 1, SINGLE for COVID-19 immunization. The patient had no medical history (none) and no relevant family medical history. Concomitant medications were not reported. Patient had no vaccines within four weeks of COVID-19 vaccine. Patient had no history of adverse event following vaccination. On 15Jul2021, after receiving first dose of vaccination, patient was breaking out in weird bumps and had one red spot in her right upper arm. She reported that about an hour after the shot she took a magnet and put it to her arm at the place she got the shot and it stuck, the magnet did not move. On 15Jul2021, patient experienced her heart was racing and felt like it was going to beat out of her chest. Her nerves were so bad, she was about to have a heart attack. Patient asked what she should do, should she go to the doctor or the emergency room. Patient did not receive any treatment in response to the event. Outcome of the events were unknown. Follow-up attempts are completed. No further information was expected.
27 2021-01-14 anaphylactic reaction Anaphylaxis- throat closing, feels SOB 15 minutes after vaccine.
27 2021-01-21 anaphylactic reaction Approx 3 -5 minutes after vaccine -redness and hives on both arms, chest, and face. Approximately 10... Read more
Approx 3 -5 minutes after vaccine -redness and hives on both arms, chest, and face. Approximately 10 minutes after vaccine- cough, shortness of breath, tongue itchy, lips swelling. Epi pen in L thigh, 50 mg benedryl IM in R deltoid. Brought to emergency room, 1 liter normal saline, pepcid, solu-medrol, 25mg benadryl IV. D/c to home around noon. 1/22/2020- secondary anaphylactic reaction at 945am. Epi pen to r thigh, 50mg PO benadryl, 20mg prednisone. Drove to hospital ER received 1 liter of normal saline, pepcid, 25mg benadryl IV, 40mg prednisone. D/C at 3pm on prednisone taper.
27 2021-01-21 pulmonary embolism Heart rate elevated to 150 and above, shortness of breath. Went to emergency room. Admitted with blo... Read more
Heart rate elevated to 150 and above, shortness of breath. Went to emergency room. Admitted with blood clot in lung. Previously had COVID in 2020, and we are unsure if this is related to previous illness.
27 2021-02-07 deep vein blood clot Deep Venous Thrombosis of Right Axillary and Subclavian vein. Treated with IV Heparin Drip.
27 2021-02-11 excessive bleeding Large amount of Bleeding at time of injection. Enough to spill all over the floor and my arm and clo... Read more
Large amount of Bleeding at time of injection. Enough to spill all over the floor and my arm and clothing. Rhen i had a severe rash weeping snd bleeding and red and bruised face and neck. Itching and hard to breathe as well as pain all over Face where rash is scabbing and oozing.
27 2021-02-13 anaphylactic reaction Anaphylaxis. Hives, anterior/posterior throat swelling, shortness of breath. Resolved with epinephri... Read more
Anaphylaxis. Hives, anterior/posterior throat swelling, shortness of breath. Resolved with epinephrine drip, receiving three epinephrine injections and Benadryl from EMS. Likely will be kept for observation given epi drip.
27 2021-02-27 vaginal haemorrhage I was 6 weeks pregnant at the vaccine, two weeks later I started bleeding and had a miscarriage. Exa... Read more
I was 6 weeks pregnant at the vaccine, two weeks later I started bleeding and had a miscarriage. Exactly 2 weeks after the vaccine. I left work that day to see the OB , had ultra sound, labs and a follow up a week later.
27 2021-03-13 vaginal haemorrhage The patient began having vaginal bleeding and contractions on 3/11/21 at 24 weeks 6 days and present... Read more
The patient began having vaginal bleeding and contractions on 3/11/21 at 24 weeks 6 days and presented to labor and delivery in preterm labor. We were able to delay delivery for about 24 hours but she did deliver at 25 weeks 0 days. Earlier in her pregnancy she had some vaginal spotting (last time was on 1/15/21 and her cervix was closed on sonogram). In her first trimester she had significant hyperemesis treated with medication and IV fluids but this resolved after the first trimester.
27 2021-03-30 anaphylactic reaction anaphylaxis; throat tightness; shortness of breath; lip swelling; throat swelling; This is a spontan... Read more
anaphylaxis; throat tightness; shortness of breath; lip swelling; throat swelling; This is a spontaneous report from a contactable nurse. A 27-year-old female patient received the first dose of bnt162b2 (lot number EN6199) via intramuscular on 04Mar2021 at 13:45 PM at single dose in left arm for COVID-19 immunisation. The patient had no COVID prior vaccination. The patient's medical history included ADHD, obesity, anxiety, history anaphylaxis to peanuts and allergies: peanuts. The patient's concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERRAL), diphenhydramine hydrochloride (BENADRYL). "5 min after injection", the patient developed throat tightness, shortness of breath, lip and throat swelling consistent with anaphylaxis. Events onset date reported as 04Mar2021 at 13:45 PM. Events resulted in emergency room/department or urgent care. The patient received epinephrine as treatment. The outcome of events was unknown. It is unknown if COVID tested post vaccination.; Sender's Comments: Based on temporal association and known drug profile the reported anaphylaxis with throat tightness, shortness of breath, lip and throat swelling are assessed as due to bnt162b2. Case will be reassessed if additional information is received.
27 2021-04-01 death Death 5 hours after second shot. Decedent contacted her mother around 3:30 c/o difficulty breathing.... Read more
Death 5 hours after second shot. Decedent contacted her mother around 3:30 c/o difficulty breathing. Died on 4/1/20
27 2021-04-02 anaphylactic reaction Anaphylactic Reaction, given epi pen at clinic and transferred to hospital by ambulance, had breathi... Read more
Anaphylactic Reaction, given epi pen at clinic and transferred to hospital by ambulance, had breathing tube inserted because swelling in throat and mouth would go down with epinephrine treatments, stayed in ICU for 4 days with epinephrine, Benadryl, and steroid treatments. Breathing tube was removed on third day in hospital.
27 2021-04-08 anaphylactic reaction Patient had swelling of lips and tongue within 15 minutes of vaccination. Given Benedryl and epi an... Read more
Patient had swelling of lips and tongue within 15 minutes of vaccination. Given Benedryl and epi and transported to ER by EMS. Report from ER: She had anaphylaxis with progressive tongue swelling despite multiple doses of IM epi and an epi drip. She was ultimately intubated to secure her airway in the face of potential airway compromise.
27 2021-04-10 brain sinus blood clot had headache rest of the day, mild and tolerable, most of thursday had headache and body aches was a... Read more
had headache rest of the day, mild and tolerable, most of thursday had headache and body aches was able to work. Friday I felt better friday night I started to get a headache again this time only on my right side, with lots of pressure. Saturday I had pressure and dull headache all day, I took Tylenol and Ibuprofen with no relief. Sunday I went to urgent care the headache was much worse now on the left side of my head, urgent care misdiagnosed me as having a sinus infection. Early monday morning I work up to a hard pulsing pain in my head, went to the ER where they found I had two blood clots in my brain (acute cerebral sinus thrombosis), one significant one obstructing blood flow and one much smaller one.
27 2021-04-12 ventricular tachycardia New onset PVCs (bigeminy, trigeminy), non-sustained ventricular tachycardia.
27 2021-04-13 anaphylactic reaction Minor anaphylaxis and hives/heat rash behind underarms near shoulder blades. Sensitivity to sunlight... Read more
Minor anaphylaxis and hives/heat rash behind underarms near shoulder blades. Sensitivity to sunlight. Minor anaphylaxis-started about 2 hours after injection and lasted approximately 8 hours. Resolved fully by next morning. Hives/heat rash behind underarms near shoulder blades-started about 3 hours after injection. Was made worse during sunlight exposure. Are minorly itchy. Sunlight Sensitivity lasted for about 24-48 hours. Seems to have resolved.
27 2021-04-14 vaginal haemorrhage vaginal bleeding concern of miscarriage abdominal pain
27 2021-04-14 vaginal haemorrhage vaginal bleeding
27 2021-05-03 grand mal seizure Patient had a grand mall seizure at work 28 hours after receiving her first Covid vaccine. She has ... Read more
Patient had a grand mall seizure at work 28 hours after receiving her first Covid vaccine. She has not had a seizure for several months. She was treated by EMTs at the scene and released to her parents after confirming she had anti seizure medications.
27 2021-05-03 vaginal haemorrhage pt says she took a pregnancy test before taking the covid vax that read positive. she had a sore le... Read more
pt says she took a pregnancy test before taking the covid vax that read positive. she had a sore left arm for about 2 days. On 4/5/2021 she had some vaginal spotting but pregnancy test was still showing positive. On 4/7/2021 she went to her PCP. They gave her a pregnancy test that was positive. They expect she was about 4 weeks along. She was referred to her OB/GYN. On 4/10/2021 she had vaginal bleeding. She contacted her PCP and was instructed to go to the ER. She went to Medical ER. they did a vaginal US, US on her stomach along w/ urine test. She was told that all results were negative and there was no longer a fetus. She was about 5 weeks along at this point. She has never been pregnant before but hormone levels are great before this incident.
27 2021-05-11 vaginal haemorrhage R56.9 - Unspecified convulsions N93.9 - Abnormal uterine and vaginal bleeding, unspecified VAGINAL B... Read more
R56.9 - Unspecified convulsions N93.9 - Abnormal uterine and vaginal bleeding, unspecified VAGINAL BLEEDING HEADACHE
27 2021-05-16 low blood platelet count, low platelet count Severe thrombocytopenia, petechial rash, dehydration, tachycardia, Idiopathic thrombocytopenic purpu... Read more
Severe thrombocytopenia, petechial rash, dehydration, tachycardia, Idiopathic thrombocytopenic purpura. Treatment involved immunoglobulin and steroids. Started immunoglobulin and steroids on April 13, 2021 Platelets started to rise next day. Hospital admit and discharge 4/13/2021-4/15/2021 Taking prednisone at home.
27 2021-05-18 deep vein blood clot admitted on 5/10/2021 for ASEPTIC NECROSIS OF BILAT FINGERS. Following admission, the patient who h... Read more
admitted on 5/10/2021 for ASEPTIC NECROSIS OF BILAT FINGERS. Following admission, the patient who has history of severe alcoholism and polysubstance abuse history, ADHD, smoker/ Vaping, on oral contraceptive, who had presented to the hospital with cyanosis of the tips of her fingers. Patient was diagnosis with dry gangrene of tips of fingers and evidence of bilateral upper extremities DVT. Patient was evaluated by vascular surgery, hematology, plastic surgery and Psychiatry . Patient was evaluated with echocardiogram and doppler of extremity. She was treated with calcium channel blocker, nitroglycerin paste and Botox injection to improve the blood flow to the extremity. The area of necrosis was stabilized. Patient was released home on 3 months of anticoagulation
27 2021-05-19 vaginal haemorrhage First dose as well as second dose of the vaccine was followed by immediate vaginal bleeding which la... Read more
First dose as well as second dose of the vaccine was followed by immediate vaginal bleeding which lasted for a week. Bleeding is still ongoing after the second vaccine shot. A red spot in the eye has appeared without any known reason.
27 2021-05-20 pulmonary embolism pulmonary embolism
27 2021-05-23 anaphylactic reaction The patient presented to hospital with anaphylaxis without clear precipitating cause, possibly secon... Read more
The patient presented to hospital with anaphylaxis without clear precipitating cause, possibly secondary to Pfizer COVID 19 vaccine. She presented to hospital on 5/22 with a lacy rash over the entire body and a change in her voice with a sensation that she couldn't breathe. She was given several doses of epinephrine, and steroids and improved, and was admitted to medicine for observation. She reported getting initially COVID-19 vaccine dose on 4/19/21. Thereafter had lacy rash over entire body for 3 days which she took as needed benadryl with improvement. After her second dose on 5/10/21 she initially had no symptoms. Approximately 6-7 days after her second dose lacy whole-body rash returned, worse than when she initially had it after first vaccine dose. She took benadryl several times but rash worsened. She had an odd sensation in her throat and noticed a change in the tone of her voice, and felt like she was having difficulty breathing. She presented to the emergency department.
27 2021-05-24 anaphylactic reaction Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: A... Read more
Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Shakiness-Mild, Systemic: Weakness-Mild
27 2021-05-28 fluid around the heart Echocardiogram results moderate circumferential pericardial effusion; Fever; stomach pain; congestio... Read more
Echocardiogram results moderate circumferential pericardial effusion; Fever; stomach pain; congestion; cough; Xray showed enlarged heart.; This is a spontaneous report from from a non-contactable consumer (patient). A 27-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Right on 02Apr2021 (Batch/Lot Number: 7533) as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included down syndrome. The patient also reported sulfa drugs (unspecified). Prior to vaccination, the patient diagnosed with COVID-19, however since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications (reported as other medications the patient received within 2 weeks of vaccination) includes: Topiramate, Buspirone, Mirtazapine, Synthroid, all taken for an unspecified indication, start and stop date were not reported. It was reported that the patient experienced Fever, stomach pain, congestion, cough, Xray showed enlarged heart and Echocardiogram results moderate circumferential pericardial effusion, all on 09Apr2021. The events resulted in Doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient underwent lab tests and procedures which included echocardiogram: pericardial effusion (moderate circumferential pericardial effusion) and x-ray: showed enlarged heart, both on 09Apr2021. The outcome of the events was recovering. Treatment include: antibiotic, prednisone. No follow-up attempts are possible. No further information expected.
27 2021-06-03 low blood platelet count Relapse of ITP 1 week after 2nd dose given (after not having an issue for 2 years)
27 2021-06-03 blood clot I have an extremely heavy period now, I woke up and there was a huge blood clot in my underwear and ... Read more
I have an extremely heavy period now, I woke up and there was a huge blood clot in my underwear and I literally gushed blood I?ve never seen that in all my 27 years of living and I?m afraid of what the next few days of my period will be like.
27 2021-06-10 cerebrovascular accident, blood clot Stroke; she had blood clots on her brain; headache; her left leg was numb like it was asleep; blurry... Read more
Stroke; she had blood clots on her brain; headache; her left leg was numb like it was asleep; blurry vision; This is a spontaneous report from a contactable consumer (patient). A 27-year-old female patient received second dose of bnt162b2 (BNT162B2, solution for injection, Lot Number: ER8736) in left arm via an unknown route of administration on 24Apr2021 at 10:10 (at the age 27-year-old) as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (BNT162B2, solution for injection, Lot Number: ER8727) right arm, via an unknown route of administration on 31Mar2021 as single dose for covid-19 immunization and experienced no adverse event. On 14May2021 at around 07:00 or 08:00, the patient experienced stroke. The patient was hospitalized for stroke from 15May2021 to May2021. On an unknown date, the patient had blood clots on her brain, headache, her left leg was numb like it was asleep, blurry vision. It was reported that patient was recently got her vision back to where she can stand the light long enough to do the research and call around. The stroke happened on 14May2021 and patient went to the hospital on 15May2021 for 5 days because she thought it was just a headache. The patient cannot find the exact date she was discharged. The vision was the first thing that went, then headache started. When patient woke up early in the morning her left leg was numb like it was asleep. Patient used the restroom and did her morning routine, and when she sat back down had the worst headache of her life. They said she had blood clots on her brain. When patient got there, they couldn't stop it because it had already happened and the damage was done. It was reported that patient knew she was going to be travelling and would start working around children. Patient was exposed to a lot of people and thought at the time it was the best thing to go ahead and get the vaccine to go back to a new normal. Patient had bloodwork test and drew so much blood trying to figure out how but results showed unknown. The most common stroke was a blood clot on the brain. Everything matches from the blurry vision to the headaches. Patient declines to report on any of the people she read about, she is just calling to report on herself. The stroke was early because her aunt had a stroke literally the week before and her wake was in the morning. She was getting ready for that. The patient had no other vaccinations within four weeks prior to the first administration date of the suspect vaccines. Patient's lab test included blood work: unknown on an unspecified date. The outcome of the events was unknown. PSCC Communication was as provided contact information for Pfizer Legal Department and report reference number to the caller. Caller declined to complete reports on the people she read about online. Information on Lot/Batch number was available. Additional Information has been requested.
27 2021-06-10 vaginal haemorrhage Vaginal bleeding began 4 days after my covid shot on May 11th and is still continuing to this day, ... Read more
Vaginal bleeding began 4 days after my covid shot on May 11th and is still continuing to this day, June 11th. I passed 4 blood clots between the days May 28 and June 5th. On May 28 and May 29, I was bleeding uncontrollably from my vagina and having to changing pads and pants every two hours. THIS DOES NOT REFLECT MY NORMAL CYCLE OR PERIOD Next, perfectly healthy before May 11th and this covid shot i had to undergo appendix surgery and had to get my appendix removed, and during surgery it ruptured in my doctors hands. Before this shot, I was a completely healthy and active 27 year old female.
27 2021-06-12 atrial fibrillation I was sitting down eating lunch at work when I had an onset of heart palpatations. I work at a hospi... Read more
I was sitting down eating lunch at work when I had an onset of heart palpatations. I work at a hospital so my coworker called a code and the rapid response team hooked me up to a monitor and they said it looked like I was in afib. I have a history of SVT but I had an ablation in 2014 and have not had palpatations since until February 15th. 2 weeks after my 2nd COVID vaccine. Not sure if this is related, but I?ve been seeing on the news that there have been heart issues in young adults linked to the vaccine.
27 2021-06-14 pneumonia Dry sick; Felt drunk out of my mind; Felt like had pneumonia or the flu; Injection site pain; Tiredn... Read more
Dry sick; Felt drunk out of my mind; Felt like had pneumonia or the flu; Injection site pain; Tiredness; Headache; Muscle pain; Chills; Nausea; Feeling unwell for about five days; Diarrhea; Vomiting; Arm pain; Felt like had pneumonia or the flu; This is a spontaneous report from a contactable consumer (patient). A 27-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 26May2021 10:30 (at 27-year-old) (Batch/Lot Number: EW0171) as 1st dose, single in arm left for COVID-19 immunisation. It's unknown if the patient was pregnant. The patient's medical history and concomitant medications were not reported. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. No known allergies. On 26May2021, injection site pain, tiredness, headache, muscle pain, chills, nausea, feeling unwell existed for about five days; and diarrhea, vomiting, arm pain occurred. It's felt like had pneumonia or the flu. Side effects hit her later that night about 9pm and she felt drunk out of her mind by 10:30 pm dry sick. No treatment received for the events. Since the vaccination, the patient hasn't been tested for COVID-19. The outcome of the events was resolving. No follow-up attempts are possible. No further information is expected.
27 2021-06-15 blood clot large blood clots, minor chest pain
27 2021-06-18 ventricular tachycardia Started having frequent episodes of symptomatic non-sustained Vtach, bigeminy, trigeminy, had an inc... Read more
Started having frequent episodes of symptomatic non-sustained Vtach, bigeminy, trigeminy, had an increased PVC burden; Started having frequent episodes of symptomatic non-sustained Vtach, bigeminy, trigeminy, had an increased PVC burden; Started having frequent episodes of symptomatic non-sustained Vtach, bigeminy, trigeminy, had an increased PVC burden; This is a spontaneous report from a contactable nurse (patient). A 27-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in arm left on 09Jan2021 (at the age of 27 years old) (Lot Number: EL1283) as 2nd dose, single for COVID-19 immunization. Medical history included Wolf-parkinson-white. No known allergies. No known drug allergy. Concomitant medications included levonorgestrel (MIRENA); melatonin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162B2 (lot number: EH9899) on 18Dec2020 ((at the age of 27 years old) in left arm for COVID-19 immunization. The patient experienced started having frequent episodes of symptomatic non-sustained Vtach, bigeminy, trigeminy, had an increased PVC burden (hospitalization) on 13Jan2021. Duration of hospitalization was 1 day. Treatment received for the events included Metoprolol. The adverse events resulted in Emergency room/department or urgent care & Doctor or other healthcare professional office/clinic visit. This is a serious report with seriousness criteria: Caused/prolonged hospitalization. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19, Nasal Swab on 13Jan2021, 03Mar2021, 10May2021, all with results of negative. The outcome of the events was recovering.; Sender's Comments: The causal association cannot be excluded between the reported events andBNT162b2 use. The impact of this report on the benefit-risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for AE. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, ethics committees and investigators, as appropriate.
27 2021-06-22 low blood platelet count The week after vaccination I was admitted into the hospital for severe menstrual bleeding. My CBC re... Read more
The week after vaccination I was admitted into the hospital for severe menstrual bleeding. My CBC result shows a platelet count of 17 10*3/uL, accompanied by low white blood cell and red blood cells count. I received multiple transfusions (2 units of whole blood and one unit of platelets), and was diagnosed with ITP. I then received steroid treatment (Dexamethasone, 40mg/day, 4days), after which my blood counts are restored.
27 2021-06-29 grand mal seizure Systemic: Fainting / Unresponsive-Mild, Systemic: Seizure-Mild, Additional Details: Patient informed... Read more
Systemic: Fainting / Unresponsive-Mild, Systemic: Seizure-Mild, Additional Details: Patient informed pharmacist of vasovagal history of passing out from vaccines. Patient passed out 3 minutes after administration and was layed to floor by pharmacist and her close friend. Patient possibly started to a 15 second tonic-clonic seizure from the vaccine. Previous history of seizures.
27 2021-07-08 vaginal haemorrhage abnormal vaginal bleeding. I completed my period on 6/24/21 and less than 2 weeks later I was bleedi... Read more
abnormal vaginal bleeding. I completed my period on 6/24/21 and less than 2 weeks later I was bleeding heavily again. I have very regular periods. This is not normal for me.
27 2021-07-14 sepsis L03.90 - Cellulitis E11.9 - Diabetes D72.829 - Leukocytosis A41.9 - Sepsis
27 2021-07-14 vaginal haemorrhage Patient cannot recall date of first Pfizer COVID 19 vaccine Stated that second Pfizer COVID 19 Vacc... Read more
Patient cannot recall date of first Pfizer COVID 19 vaccine Stated that second Pfizer COVID 19 Vaccine received 6/5/2021 On 6/6/2021 patient report unscheduled/irregular vaginal/uterine bleeding all day On 6/7/2021 bleeding resolved spontaneously
27 2021-07-16 anaphylactic reaction Anaphylaxis Epipen administered and patient taken to emergency room
27 2021-07-22 blood clot on and off numbness in my left arm along with a blood clot on my left hand, and the left side of my ... Read more
on and off numbness in my left arm along with a blood clot on my left hand, and the left side of my back; headache; on and off numbness in my left arm along with a blood clot on my left hand, and the left side of my back; patient had increased heart rate; swelling of the throat; a very sore arm; sore arm proceeded the next day and the following day arms soreness was very minimal on 11Jul2021; This is a spontaneous report from a contactable consumer (the patient). A 27-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: FA6780, expiration date was not reported) via an unspecified route of administration, in the left arm, on an 10Jul2021 at 12:45 (at the age of 27-year-old), as single dose, for COVID-19 immunization. The patient's medical history included allergies to Metal. Concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not receive any other medications within 2 weeks of vaccination. Patient was not diagnosed with COVID-19 prior to vaccination. Patient was not tested for COVID-19 since the vaccination. On 10Jul2021 at 16:00, a few minutes after the first dose, patient had increased heart rate, swelling of the throat and had a very sore arm; sore arm proceeded the next day and the following day arms soreness was very minimal on 11Jul2021. On 13Jul2021 at 16:00, on the fourth day, patient had a headache, increased heart rate, and on and off numbness in my left arm along with a blood clot on my left hand, and the left side of my back (injected arm). Outcome of the events was not recovered. Follow-up actions are needed. Further information has been requested.
27 2021-07-23 anaphylactic reaction 27yoF without hx of anaphylaxis had acute N/V and shakiness about 10mins after 1st dose of Pfizer va... Read more
27yoF without hx of anaphylaxis had acute N/V and shakiness about 10mins after 1st dose of Pfizer vaccine was administered. Vitals 118/74, HR 80s, RR 22. Was speaking fine throughout, w/o any SOB/wheezing or chest pain. Sx were resolved after 10 mins. Had extended monitoring x30 minutes and remained at baseline and was allowed to leave vaccine blitz site. Instructed that 2nd vaccine should be given in Clinic.
27 2021-07-27 vaginal haemorrhage Vaginal Blood Spotting; This is a spontaneous report from a non-contactable consumer. A 27-years-old... Read more
Vaginal Blood Spotting; This is a spontaneous report from a non-contactable consumer. A 27-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: not reported), via an unspecified route of administration, in arm Left on 09Mar2021 at 15:30 (at the age of 27-years-old) as dose 1, single for COVID-19 immunisation. The patient medical history was not reported. Concomitant medication included etonogestrel (NEXPLANON), vitamin d nos, ascorbic acid vitamin c [ascorbic acid], fish oil and daily Multi (unspecified). On 11Mar2021 at 08:00, the patient experienced vaginal blood spotting. The patient received no other vaccine in four weeks. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 11Jan2021. Treatment was not given for the event. The patient tested covid post vaccination and covid test result was negative on 11Jan2021. Outcome of the event was not recovered. No follow-up attempts are possible; information about lot/batch number cannot been obtained.
28 2021-01-11 anaphylactic reaction Anaphylaxis Chest tightness started @ 6:00pm following vaccine. Developed wheezing in all lung fiel... Read more
Anaphylaxis Chest tightness started @ 6:00pm following vaccine. Developed wheezing in all lung fields (confirmed by MD.) Developed hives- Albuterol, Benadryl and epinephrine administered @ 700pm. EMS called and transported to Hospital.
28 2021-01-12 anaphylactic reaction Anaphylaxis c/o chest tightness and "unable to breathe"-epi pen administered with immediate response... Read more
Anaphylaxis c/o chest tightness and "unable to breathe"-epi pen administered with immediate response. Narrative: c/o chest tightness. epi pen administered with immediate response. "I can breath now," pt. stated. Monitored, d/c'd to home/released from work.
28 2021-01-26 anaphylactic reaction My arm started to hurt , tingled and then turned into feeling very heavy as soon as injection was ad... Read more
My arm started to hurt , tingled and then turned into feeling very heavy as soon as injection was admitted. I suddenly became light headed and felt very abnormal. Broke out in hives on my neck and face . They took me to the ER department and by the time they wheeled me down the hall I was white , very disoriented. Couldn?t open my eyes and went from slurred speech to I couldn?t speak at all and couldn?t swallow. My throat and closed and I was having a anaphylactic reaction . They administered epi pen , pepcide and steroids. Since then I have been very weak , running a fever , tired , dizzy . Can hardly walk and I get out of breath from standing or walking .My muscles are very sore and have spams . Almost last night I went to the ER due to theses symptoms lingering. I have been unable to work since the vaccine was administered to me .
28 2021-01-26 anaphylactic shock Anaphylaxis shock- patient became hypoxic with shortness of breath, chills and tachycardia. EpiPen w... Read more
Anaphylaxis shock- patient became hypoxic with shortness of breath, chills and tachycardia. EpiPen was administered and 911 was called. Patient was transported to ER.
28 2021-02-02 anaphylactic reaction 28 yo F here at 30mdg for covid vaccine. pt with h/o "anaphylaxis with other shots." Pt notes had f... Read more
28 yo F here at 30mdg for covid vaccine. pt with h/o "anaphylaxis with other shots." Pt notes had facial/nose/lip tingling with prior vaccines, requiring steroids and oral Benadryl. Patient received the covid vaccine at approx 1715 on 21 Jan 2021. At approx 15 minutes, pt developed numbness and tingling to her nose and lips. pt notified Rapid Response Team, who notified Physician. monitored patient for 5-7 min, pt noted that her symptoms were worsening, to include numbness and tingling affecting most of her face, cheeks, lips and nose. No trouble breathing. no lip swelling or tongue swelling. HR 78. Gave oral benadryl - gave her 4 ml of po benadryl (12.5 mg/5ml) at approx 1735, and another 4 ml po benadryl (12.5 mg/5ml) at approx 1740. pt prefers to be treated with steroids because a similar previous episode resolved with benadryl and steroids. pt symptoms persisted with facial numbness and tingling ... and subjectively were worsening. no coughing, no tongue swelling. no lip swelling. no shortness of breath. FM physician arrived - prepped for 60 mg im solumedrol. at approx 1750, FM physician gave IM Solu-Medrol in R shoulder. pt waited for approx 15 min - felt better. numbness and tingling of face and nose were lessening, almost gone - only tip of nose was affected. no facial swelling. no lip or tongue swelling. no trouble breathing. no shortness of breath. physician gave return parameters - benadryl prn overnight called patient the following monday - stated she slept that night (from benadryl), felt better the next day. no further concerns
28 2021-02-05 anaphylactic reaction 10 minutes after vaccine, patient became unconscious and fell out of chair. Began gasping for air an... Read more
10 minutes after vaccine, patient became unconscious and fell out of chair. Began gasping for air and clenching fists. Epinephrine was administered immediately. Patient began breathing normally after a few minutes. The whole event lasted about 5 minutes. Patient disclosed afterwards she had a fear of needles. This did not look like a panic attack, it appeared to be a true anaphylactic response.
28 2021-02-08 vaginal haemorrhage I found out I was pregnant the day after receiving the first dose of the COVID-19 vaccine. My last p... Read more
I found out I was pregnant the day after receiving the first dose of the COVID-19 vaccine. My last period was on December 8th and I received the vaccine on Dec 30th. I developed a fever and muscle aches after the first dose, but was managed with Tylenol. I received the second dose on January 22nd and again developed a fever that was managed by Tylenol. I began having vaginal bleeding on 24th. I had an ultrasound revealing a heartbeat on the 25th. After continually bleeding, another ultrasound a week later on Feb. 2nd confirmed a miscarriage. I've had two healthy pregnancies prior to this one.
28 2021-02-10 vaginal haemorrhage Miscarriage at 6 weeks 1 day. Vaginal bleeding and decline in HCG hormone. Pregnancy not viable.
28 2021-02-16 cerebrovascular accident stroke; a thunder clap headache; limbs stiffened up; eyes crossed; lost speech; She is now on day th... Read more
stroke; a thunder clap headache; limbs stiffened up; eyes crossed; lost speech; She is now on day three of a coma on life support from a brain aneurysm; Mood swings; irate; Body aches; This is a spontaneous report from a Contactable Consumer, the patient. This 28-year-old non-pregnant female consumer (patient) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: Unknown), via an unspecified route of administration in the left arm on 01Feb2021 as a single dose, for COVID-19 vaccination. Historical vaccination includes BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), Dose 1. The facility in which the second vaccine was administered was a hospital. No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. No Medical history reported ('No health issues, At all'). The patient has no known allergies. There were no concomitant medications. On an unspecified The Patient Experienced became irate. Mood swings. Body aches for couple days; On 07Feb2021 at 13:45, The patient experienced Stroke a thunder clap headache, limbs stiffened up , eyes crossed, lost speech, now on day three of a coma on life support from a brain aneurysm (hospitalization, disability, life threatening), Treatment was given for the events of stroke, a thunder clap headache, limbs stiffened up, eyes crossed, lost speech, and brain aneurysm. The Adverse Event resulted in an Emergency Room Visit. Treatment was given for the events. 'Patient on Life support still'. The Clinical Outcome of the events Stroke a thunder clap headache, limbs stiffened up , eyes crossed, lost speech, now on day three of a coma on life support from a brain aneurysm not recovered, while Mood Swings, Anger and Pain was unknown. Information on Lot has been requested.
28 2021-02-17 excessive bleeding Patient was newly pregnant, received 2nd dose of covid vaccine. Patient then began bleeding on 2/13... Read more
Patient was newly pregnant, received 2nd dose of covid vaccine. Patient then began bleeding on 2/13/21. On 2/15/21 confirmed with OBGYN that HCG levels were low and that she was having a miscarriage. Patient has a healthy 2 year old living child. No past history of miscarriages, no family history of miscarriage.
28 2021-03-13 anaphylactic shock Symptoms: Fainting, Unconciouness (repeatedly), Profusive Sweating, Low Blood Pressure (60 over unkn... Read more
Symptoms: Fainting, Unconciouness (repeatedly), Profusive Sweating, Low Blood Pressure (60 over unknown number), Nausea, Dizziness, Unable to stabilize quickly, not able to get an IV, extreme thirst Signs: Immediately felt unwell within 5 minutes of the vaccine. Time Course: Injection (1st dose - Pfizer) at 4:00pm. Adverse Reaction at 4:05/4:10 (est.) Released at 5:00pm (est.) Description of Incident: On March 8th, at 4:00 pm, I received my first dose of the covid vaccine. Within 5 to 7 minutes, I felt unwell while sitting in the waiting area. I walked towards a worker to inform them that I was feeling unwell and that I was going to pass out. I became unresponsive and laid on the ground. My husband was with me at the time. I was unconscious for a bit and when I regained consciousness, my legs were being raised. I regained consciousness and was able to recall my name, DOB, and address. After I was done recalling my information, I began to lose consciousness again. They brought a wheelchair and took me to the medical room. As I moved from the wheelchair to the bed, I began to lose consciousness again. They told me to lay down. I overheard a woman ask my husband if I had diabetes or heart problems. He answered ?No.?. She explained to him that my body did not know how to accept the vaccine and was trying to regulate back to normal. She explained that my body was going through ?homeostasis? (?). While I laid on the bed, some workers took my blood pressure and tried to start an IV. One of them made a comment and said I was extremely dehydrated. This was odd to hear because I normally drink 3 to 4 liters of water daily. During this entire medical event, I felt the water pushing out through my pores. I was drenched in sweat. He tried to start an IV on my left arm and was unsuccessful. He tried to start an IV on my right hand, which was also unsuccessful. He stated they were unable to start IV liquids because my veins kept popping/collapsing. My blood pressure was reading 60. They checked it again, still at 60. I laid in the bed and basically waited it out. After a few minutes, they checked my blood pressure at it was at 120. They said that was good and I was good to go. No report was given to me nor my husband about the event that occurred. Even after they agreed to let me use a wheelchair (due to feeling weak), one was not provided to me. They basically stated that I was ?good to go?, after doing a series of hand squeezes and walking a few steps upright. I am currently trying to obtain a copy of the report I saw the gentleman fill out at the time. I was given Zofran to help with my nausea, it was placed under my tongue. After going home, I felt weak, tired and somewhat lightheaded. My husband drove me home and I got some rest. I set an appointment with my doctor on Friday March 12th to determine what happened to me during my vaccine and to record the incident. After describing the incident, she determined that it was anaphylaxis. She recommended for me not to get my second dose due to the anaphylactic shock I experienced with the first dose. She was shocked to learn that they did not transport me to the hospital or provided an Epi Pen injection. When asked why I didn?t drive myself to the hospital, I let her know that they told me I was ?good?. They did not explain what had occurred to me, no mention of anaphylaxis was explained. I was not aware that is what had occurred. The incident occurred from 4:00pm (injection time) to 5:00pm (left location).
28 2021-03-13 deep vein blood clot vein thrombosis
28 2021-03-16 vaginal haemorrhage Miscarriage of baby due on 10/3/21.
28 2021-03-18 vaginal haemorrhage Heavy vaginal bleeding noticed a few hours after injection. I have been spotting (1 pad daily) becau... Read more
Heavy vaginal bleeding noticed a few hours after injection. I have been spotting (1 pad daily) because of my birth control, but now I?m using 6-7 pads a day and soaking through them. I?m not sure if it?s related but I?m also extremely fatigued and having chills. Should I ask for a blood test for my platelet count? I?ve read it is a very rare reaction for some to have lower counts.
28 2021-03-21 transient ischaemic attack Slurred speech event for 15 seconds while working. Continued elevated DDimer and other various cloth... Read more
Slurred speech event for 15 seconds while working. Continued elevated DDimer and other various clothing labs post event. TIA event with continued hypercoagulation
28 2021-03-22 anaphylactic reaction Anaphylaxis
28 2021-03-22 anaphylactic reaction I went to the medical facility for a covid vaccine today. I received the Pfizer vaccine. I started t... Read more
I went to the medical facility for a covid vaccine today. I received the Pfizer vaccine. I started to have a reaction to it and was instructed by the physician on site to use my epi pen. Symptoms resolved within 5-10 minutes of using my epi pen. The on site MD called EMS and I was transported to ED for obs. I was discharged shortly thereafter. I have a hx of anaphylaxis both idiopathic and to iron dextran and basil.
28 2021-03-23 anaphylactic reaction Anaphylactic reaction requiring epinepharine
28 2021-03-24 grand mal seizure Generalized Tonic-Clonic Seizure; feeling unwell; slightly nauseous; still a little slow in speech a... Read more
Generalized Tonic-Clonic Seizure; feeling unwell; slightly nauseous; still a little slow in speech and gait; still a little slow in speech and gait; This is a spontaneous report from a contactable consumer (patient). A 28-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6202), via an unspecified route of administration, administered in arm right on 05Mar2021 08:00 as a single dose (at the age of 28-years-old) for Covid-19 immunisation. The patient was not pregnant at the time of vaccination. Medical history included epilepsy, hypopituitarism, central diabetes insipidus, neoplasm of brain, irregular menses, short-term memory loss, elevated LDL, and myopia w/ astigmatism. The patient had known allergies to surgical tape and contrast dyes. Concomitant medications included desmopressin acetate (DDAVP), lamotrigine (LAMICTAL), levetiracetam, and zonisamide; all were taken for an unspecified indication, start and stop date were not reported. The patient previously took amoxicillin and experienced drug allergy. On 08Mar2021 at 06:15 PM, the patient experienced generalized tonic-clonic seizure, feeling unwell, slightly nauseous, still a little slow in speech and gait. Therapeutic measures were taken as a result of generalized tonic-clonic seizure, feeling unwell, slightly nauseous, still a little slow in speech and gait as Nayzilam 5 mg two doses was administered. Clinical course details as reported: the patient finished dinner and evening medications before 6 pm and started feeling unwell and slightly nauseous soon after. Laid on sofa, started to sit up at 6:20 pm, and went into a Generalized Tonic-Clonic Seizure. The patient's father administered Nayzilam 5 mg (2 doses); seizure ended and the patient went into a deep sleep until 8:00 pm. The patient was largely recovered, but still a little slow in speech and gait. The outcome of the events was recovering as reported. Information on the lot/batch number has been requested.
28 2021-04-07 anaphylactic reaction Anaphylactic reaction, throat swelling, tongue swelling, confusion - Epi pen administered 15 minutes... Read more
Anaphylactic reaction, throat swelling, tongue swelling, confusion - Epi pen administered 15 minutes after the vaccine and transported to the ER via ambulance. Gave me Benadryl, zofran, headache medicine, fluids
28 2021-04-10 deep vein blood clot DVT in right calf. Pain, no redness or swelling. Pain felt first on Thursday morning, then went away... Read more
DVT in right calf. Pain, no redness or swelling. Pain felt first on Thursday morning, then went away. Pain came back throughout Saturday. Slept with leg elevated Saturday night, but woke up from the pain on Sunday. Couldn?t put weight on right leg. Went to the ER two hours later, though pain had receded a bit. D-dimer test revealed elevated clotting factors. Ultrasound revealed extensive clot in calf.
28 2021-04-11 anaphylactic reaction, anaphylactic reaction dyskinesia and anaphylaxis
28 2021-04-11 blood clot One month after having my second covid vaccine, I had the worse menstrual cycle of my life. I had he... Read more
One month after having my second covid vaccine, I had the worse menstrual cycle of my life. I had heavy bleeding for 4 days and horrible menstrual cramps. So bad that motrin/tylenol did not take away the pain. Also passed a lot of clots. Also after my period, I've had continual bleeding/spotting. I've even gone to the OBGYN to get checked. I'm still bleeding...
28 2021-04-12 blood clot Blood clot in left Iliac vein
28 2021-04-20 deep vein blood clot DVT in my right calf; I felt pain in my calf between 10-20 hours before second vaccine dose. The pai... Read more
DVT in my right calf; I felt pain in my calf between 10-20 hours before second vaccine dose. The pain went away but came back 5 hours after second vaccine dose. In the next 10 hours, the pain became severe and constant; I felt pain in my calf between 10-20 hours before second vaccine dose. The pain went away but came back 5 hours after second vaccine dose. In the next 10 hours, the pain became severe and constant; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a 28-year-old female patient received second dose of BNT162B2 (Lot Number: ER8734), via an unspecified route of administration, administered in the left arm on 02Apr2021 as a single dose for COVID-19 immunization. The patient previously received first dose of BNT162B2 via an unspecified route of administration, administered in Arm Left on 12Mar2021 (Batch/Lot Number: EP7534) for COVID-19 immunization. Medical history included corneal abrasion and pain in my calf, both from an unknown date and unknown if ongoing. Concomitant medications included tetryzoline hydrochloride (EYE DROPS [TETRYZOLINE HYDROCHLORIDE]) taken for an unspecified indication, start and stop date were not reported. The patient experienced DVT in her right calf on an unspecified date and 'felt pain in my calf between 10-20 hours before second vaccine dose. the pain went away but came back 5 hours after second vaccine dose. in the next 10 hours, the pain became severe and constant' on 02Apr2021. The clinical course was reported as follows: The patient felt pain in her calf between 10-20 hours before second vaccine dose. The pain went away but came back 5 hours after second vaccine dose. In the next 10 hours, the pain became severe and constant. At 40 hours after second vaccine dose, she went to the ER and was diagnosed with a DVT in her right calf. The adverse events result in Emergency room/department or urgent care. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of both events which included blood thinners. The outcome of the events was recovering.
28 2021-04-22 cerebrovascular accident, transient ischaemic attack Right arm numbness, 04/15, 5:00pm Facial dropping, 04/18, 12:00pm Right side face paralysis, 04/19, ... Read more
Right arm numbness, 04/15, 5:00pm Facial dropping, 04/18, 12:00pm Right side face paralysis, 04/19, 11:00am Headaches, 04/16, 3:00pm TIA/ stroke, 04/19 11:00am
28 2021-04-23 vaginal haemorrhage I was exactly 4 weeks pregnant at the time of my second vaccination. On March 23 I started to develo... Read more
I was exactly 4 weeks pregnant at the time of my second vaccination. On March 23 I started to develop cramping in uterus. On March 25 or March 26 (I cannot remember exactly which day here) I started spotting, and then by the next day I was bleeding. On March 29 I saw my OBGYN who diagnosed me with a miscarriage. I continued to bleed for approximately 10 days, as well as dizziness, and feeling very faint. I have had 2 very healthy pregnancies in the past and no health issues. This could be absolutely unrelated, as early miscarriages are almost impossible to pinpoint, but I did feel this should be reported for researching purposes.
28 2021-04-24 anaphylactic reaction Anaphylactic reaction-throat and tongue swelling; This is a spontaneous report received from a conta... Read more
Anaphylactic reaction-throat and tongue swelling; This is a spontaneous report received from a contactable consumer (patient). A 28-year-old non-pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection and Lot Number: unknown) via an unspecified route of administration in the left arm on 24Mar2021 at 13:45 (at the age of 28-year-old) as a single dose for COVID-19 immunization in Workplace Clinic. Medical history included ulcerative colitis, hyperthyroidism, hypertension and known allergies: Cephalexen and NSAIDS. The patient did not receive other vaccine in four weeks and received other medications (unspecified) in two weeks. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 24Mar2021 at 14:00, the patient experienced anaphylactic reaction - throat and tongue swelling, which resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient received Epi pen (administered 15 minutes after injection of vaccine), benadryl, ER trip, fluids and headache medication as a treatment for the event. The patient recovered with lasting effects. The outcome of the event was recovered with sequel.
28 2021-04-25 vaginal haemorrhage The next day after receiving my vaccination, I started having vaginal bleeding. However 2 weeks prio... Read more
The next day after receiving my vaccination, I started having vaginal bleeding. However 2 weeks prior to my vaccination I already had my menstrual cycle. I typically either spot or have a small period that lasts 3-4 days due to my birth control (implant). Today 4/26/21, I am still currently experiencing heavy vaginal bleeding, and I am not sure if I consider this my menstrual cycle. It is now more than 2 weeks and I am still bleeding.
28 2021-04-27 pulmonary embolism PE; This is a spontaneous report from a contactable Nurse. A 28-year-old female patient received the... Read more
PE; This is a spontaneous report from a contactable Nurse. A 28-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: Ek9231), via an unspecified route of administration, administered on the left arm, at the age of 28 years, on 12Jan2021 at a SINGLE DOSE for covid-19 immunisation. Medical history included asthma, angiolipoma, labral surgery to hip, drug hypersensitivity to penicillins; all from an unknown date and unknown if ongoing. Concomitant medications included ethinylestradiol, norethisterone acetate (JUNEL FE 1/20) and cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]); both taken for an unspecified indication, start and stop date were not reported. The patient previously took amoxicillin and experienced drug hypersensitivity, bactrium ds and experienced drug hypersensitivity, doxycycline and experienced drug hypersensitivity. The patient received first dose of COVID vaccine BNT162B2 (lot number= Ej1685) at the age of 28 years on 22Dec2020 on the left arm at single dose for COVID-19 immunization. The patient reported that 2 weeks after the second vaccine, she underwent hip labral surgery and suffered a PE on 22Feb2021. She was not sure if the vaccine could have contributed to the PE or just the surgery but wanted to report just incase. She was taking aspirin to prevent DVT's. The patient was hospitalized for pe (pulmonary embolism) for 3 days. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 22Feb2021. Therapeutic measures (DOAC) were taken as a result of pe (pulmonary embolism). The outcome of the event was recovering.; Sender's Comments: The event pulmonary embolism is likely an intercurrent medical condition and unrelated to BNT162B2. Patient's hip surgery two weeks after the vaccine might have contributed to the event onset. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
28 2021-04-29 vaginal haemorrhage A week after receiving my vaccine I noticed vaginal spotting and thought I was getting my menstrual ... Read more
A week after receiving my vaccine I noticed vaginal spotting and thought I was getting my menstrual cycle. That spotting turned into heavy bleeding and hasn't stopped for 3 weeks
28 2021-04-29 vaginal haemorrhage Within 7 hours of receiving the vaccine, I started what I thought was my second period of the month.... Read more
Within 7 hours of receiving the vaccine, I started what I thought was my second period of the month. I had just finished a period 12 days earlier. I am usually 35 - 42 days between periods so this was VERY unusual for me. I had my normal period pre-vaccine Jan 4 - 9 then 7 hours after the vaccine started bleeding again from the 21-25 of January. Then again on Feb 4 - 9. I got my second vaccine while bleeding. Then again started to bleed on Feb 21 - 25. I had a doctors appointment at the end of February. I got an annual gyno exam as well as a ton of bloodwork was taken to check everything out. I was told to continue to monitor the bleeding and if it didn't stop we would do a pelvic ultrasound. Well, it didn't stop so we did and it came back normal. I had a mostly normal March with light bleeding. I thought perhaps it was getting better but no. I have had two periods in April. In fact still bleeding on round two and this is my 6th day bleeding. Periods or irregular bleeding was April 12-17 and then again on April 24 - 29 (still happening and it's the 29th). This is very scary to me as no doctors can help.
28 2021-05-03 pulmonary embolism Pulmonary embolism L lung, unknown origin.
28 2021-05-11 vaginal haemorrhage O20.0 - Threatened abortion O20.8 - Other hemorrhage in early pregnancy VAGINAL BLEEDING - PREGNANT
28 2021-05-19 excessive bleeding May 4th - Therapeutic rest - had been having contractions for a couple of days and hadn't had sleep... Read more
May 4th - Therapeutic rest - had been having contractions for a couple of days and hadn't had sleep- admitted to hospital. May 6 baby was born. I was full term - 40 weeks and six days. I was in labor and admitted for labor and delivery. Baby was born with a vacuum assist and had some risk for jaundice but didn't get a jaundice diagnosis. Small for gestation age - Baby's size - 6 lbs and 9 oz. I had some blood loss and did have a blood transfusion after deliver. It was my first pregnancy.
28 2021-05-19 blood clot Severe calf muscle cramps, possible blood clot; Severe calf muscle cramps, possible blood clot; This... Read more
Severe calf muscle cramps, possible blood clot; Severe calf muscle cramps, possible blood clot; This is a spontaneous report from a contactable other hcp. A 28-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Right on 24Mar2021 12:00 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization. Medical history was reported as "none". The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. the patient previously received the first dose of BNT162B2 on 26Feb2021 at 10:00 administered in the left arm for COVID-19 immunization. The patient's concomitant medications were not reported. The patient experienced severe calf muscle cramps, possible blood clot on 01Apr2021 12:00. The outcome of events was not recovered. Patient did not receive any treatment for the events. Follow up needed, further information has been requested; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. Case will be reassessed upon receipt of follow-up information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
28 2021-06-02 heart attack having a heart attack might feel like; tightening around upper body especially around the base of he... Read more
having a heart attack might feel like; tightening around upper body especially around the base of heart; inflammation; heart beat became rapid; short of breath; This is a spontaneous report from a contactable consumer. A 28-year-old female patient received the second dose of bnt162b2 (Pfizer-Biontech COVID-19 vaccine) via an unspecified route of administration in left arm on 18May2021 04:15 PM (Lot Number: EW0165) at single dose for COVID-19 immunization. The patient's medical history included penicillin allergy and migraines/psoriasis. The patient was not diagnosed with COVID-19 prior to vaccination. The patient's concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (Pfizer-Biontech COVID-19 vaccine) via an unspecified route of administration in right arm on 27Apr2021 04:15 PM (Lot Number: EW0175) at single dose for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had tightening around upper body especially around the base of heart, accompanied by inflammation. Her heart beat became rapid and she was short of breath. The event start date and time was reported as 18May2021 07:30 PM. It was also reported this happened "4.5 hours after injection". The event lasted 25 minutes. The patient felt what she assumed having a heart attack might feel like. The events were reported as non-serious. The patient did not receive treatment. The outcome of event was resolved. The patient has not been tested for COVID-19 since the vaccination.
28 2021-06-18 anaphylactic reaction 1st day fine June 1 2021 Day 2 muscle aches joint pain malaise fever chills Day 3 nighttime/ morning... Read more
1st day fine June 1 2021 Day 2 muscle aches joint pain malaise fever chills Day 3 nighttime/ morning of day 4 anaphylaxis Day 4 morning epi pen at urgent care/ tachycardia Day 5 tachycardia Day 6 tachycardia Day 7 tachycardia and migraine followed by numb right side arm / leg/ face Corticosteroids taken Day 9 visit ER FOR NUMBNESS to rule out stroke Corticosteroids end June 12 (tachycardia and shortness of breath continue since the symptoms first noticed) Night of 13th day anaphylaxis Urgent care june 14: prescribed beta blockers epi pens and corticosteroids Effects continuing today: Tachycardia (baseline prior to shot was 60 resting heart rate and now is in the 100+, going up 10 stairs causes it to hit 160, small movement triggers it- beta blockers help sometimes) Numbness on right side: face arm leg foot etc Chest pain, chest tightness, shortness of breath
28 2021-06-20 fluid around the heart First dose of Pfizer - 03/06/2021 at a Coliseum. Second dose of Pfizer - 04/03/2021 at pharmacy. Pr... Read more
First dose of Pfizer - 03/06/2021 at a Coliseum. Second dose of Pfizer - 04/03/2021 at pharmacy. Presented to the ED at on 5/9/21 with fever to 39.6C, HR 120s, throat pain, myalgias, headache, improved with IVF, tylenol, ibuprofen. Re-presented to ED on 5/13/21 with fever 39.5C, HR 120s, chest pain, dyspnea on exertion limiting her ability to walk >2 blocks as well as the remainer of her prior symptoms, with troponin 1.95 and TTE with new pericardial effusion. No sick contacts. Admitted at hospital 5/13 - 5/16 for myopericarditis, improved with colchicine, ibuprofen, and fluids. Sx persistent at post-discharge clinic visit.
28 2021-06-20 vaginal haemorrhage severe vaginal bleeding with many clots over several days, outside of the menstrual period.
28 2021-06-24 pulmonary embolism Bilateral Pulmonary Emboli-- 1 blood clot in both lungs. Recently have been referred to Hematology d... Read more
Bilateral Pulmonary Emboli-- 1 blood clot in both lungs. Recently have been referred to Hematology dept (June 2021) due to a suspected blood clotting disorder after follow up labs were completed.
28 2021-06-28 anaphylactic reaction Unknown site, unknown number in series, unknown lot Anaphylaxis Reported by patient to PCP
28 2021-06-29 vaginal haemorrhage Vaginal bleeding in pregnancy, first trimester
28 2021-07-07 excessive bleeding Pregnancy history: 3 full term LIVE pregnancies No previous miscarriages Due date was December 7th, ... Read more
Pregnancy history: 3 full term LIVE pregnancies No previous miscarriages Due date was December 7th, 2021 Genetic/chromosomal blood testing was performed at 10 weeks and 2 days gestation on May 13, 2021: confirmed gender was male and everything was normal and healthy. Ultrasounds were performed both at 9 weeks gestation and at 13 weeks gestation (genetic/chromosomal screening) and everything was normal and healthy. On June 24th (16 weeks 3 days): was seen in ER due to upper abdominal pain. Was diagnosed with a miscarriage that occurred around 14 weeks gestation. Procesure (D&E) to remove fetus took place June 29, 2021. I lost over 3 pounds of blood and almost died following procedure.
28 2021-07-18 anaphylactic reaction Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Rash Generalized-Medium, Systemic: Faint... Read more
Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Rash Generalized-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Seizure-Severe, Systemic: Tachycardia-Medium, Additional Details: pt history of seizure disorder, did not mention her last seizure was 2 days before vaccination. went unresponsive and had epipen given, then had several seizures and was taken by EMS
28 2021-07-19 vaginal haemorrhage O20.0 - Threatened miscarriage in early pregnancy vaginal bleeding
28 2021-07-21 vaginal haemorrhage Fever, hot arm, uncontrollable shaking, severe headache, nausea, fatigue, vaginal bleeding (not as t... Read more
Fever, hot arm, uncontrollable shaking, severe headache, nausea, fatigue, vaginal bleeding (not as thick as period blood)
29 2021-01-03 anaphylactic reaction rash, hives, anaphylaxis, throat tightening, felt out of body
29 2021-01-07 anaphylactic reaction Anaphylactic reaction; hives in the first 10 minutes of the vaccine; This is a spontaneous report fr... Read more
Anaphylactic reaction; hives in the first 10 minutes of the vaccine; This is a spontaneous report from a contactable Other Health Professional (Physician Assistant). A 29-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 29Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter stated that she is treating a patient in ICU that got the COVID-19 vaccine on 29Dec2020. The patient developed hives in the first 10 minutes of the vaccine and had an anaphylactic reaction 1 hour later. Seriousness of events was reported to be hospitalization. Outcome of the events was unknown. The reporter also mentioned that it was not a mild reaction and patient was still in the ICU, 48 hours later. Information about lot/batch number has been requested.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of anaphylactic reaction and hives cannot be excluded, considering the plausible temporal relationship and the known adverse event profile of the suspect product. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
29 2021-01-17 excessive bleeding Started to have symptoms and fainted; Hit her nose and has a scar now; She blacked out; hit her nose... Read more
Started to have symptoms and fainted; Hit her nose and has a scar now; She blacked out; hit her nose, got the scar in the nose, …she was bleeding from that scar; hit her nose, got the scar in the nose, …she was bleeding from that scar; She started to feel unwell; Chills; Nausea; Rash in her arm; She had little red in her bumps; This is a spontaneous report from a contactable physician. A 29-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Solution for injection, batch/lot no. and expiry date: unknown), via an unspecified route of administration on arm on unspecified date at a single dose (2nd dose) for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Physician stated, "she had no medical conditions, she was in very good you know very like standing with herself." Patient had her 1st dose of Covid vaccine on unspecified date for COVID-19 immunization. Physician (reporter) stated, "I am the parent of someone who got the COVID dose, the second dose yesterday. I am very concerned because my daughter yesterday (08Jan2021) started to have symptoms and fainted at 4:00 in the morning and hit her nose and has a scar now. She had her second dose yesterday (pending clarification), after the second dose last night she started to feel unwell, getting chills, nausea and when she got up to go to the bathroom, she fainted, she blacked out. She lives alone, she is an adult, she hit her nose, got the scar in the nose, and the bleeding wouldn't stop, she was bleeding from that scar. She told me it took two hours for bleeding to stop from that scar." When asked when the events started, Physician stated, "Last night (08Jan2021), at 4:00 am she took the shot during the day while she was at work. She said, she started to getting chills and then she was nauseated." When asked if patient was still experiencing the event, the parent reported no as patient was just resting. Also stated, "She didn't take any treatment but she said she took Tylenol." Physician further added, "I am concerned, we are going to be taking her to the urgent care now but I am concerned about what is going on with platelets and all of that because of what had happened, last night the bleeding wouldn't stop for two hours and she was alone at the night and weekends. She said, she had to lay down and then her dad is there now because he is closer, he is going to be taking care of the urgent care but I want Pfizer to know what my daughter has gone through last night after she took this second dose." Physician further added, "she is having a rash in her arm, she had little red in her bumps as well. I want her to go get checked up as soon as possible in urgent care." Patient was taking some Ibuprofen (later clarified that patient took Tylenol as treatment). She was not taking any other medication. Outcome of the events was unknown. Information Requested on Lot/ Batch number.; Sender's Comments: The reported faint was most likely due to an accident, and less likely causally related to the use of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE). The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
29 2021-01-21 anaphylactic reaction Anaphylaxis. Upper Extremity Rash, and Shortness of breath with throat swelling.
29 2021-01-24 pulmonary embolism Having a head arch, chest pains and shortness of breath pulmonary embolism and was tested for COVID-... Read more
Having a head arch, chest pains and shortness of breath pulmonary embolism and was tested for COVID-19 and tested positive.
29 2021-01-26 anaphylactic reaction Systemic: Anaphylaxis-Severe, Systemic: Rash (other than injection site)-Medium, Systemic: Headache-... Read more
Systemic: Anaphylaxis-Severe, Systemic: Rash (other than injection site)-Medium, Systemic: Headache-Severe, Systemic: Other- Itching-Severe
29 2021-01-26 vaginal haemorrhage Upon receiving my first shot, I felt weak, and after a few days a tingly feeling in my head. Symptom... Read more
Upon receiving my first shot, I felt weak, and after a few days a tingly feeling in my head. Symptoms lasted for 2 weeks. After receiving the second dose, I had a fever that evening and weakness, it lasted through the next day. My right arm was sore for 2 days. I took Advil, Tylenol, and ibuprofen (at different times). Symptoms of fever lasted two days and were gone, I was left feeling weak, it lasted for a day. Now day 5 after I got my shot (got the last dose 1/22/2021), I have noticed some vaginal bleeding that has been going on for 2 days now (It's not the menstrual period since I had that going on a week before I got my last shot). I am wondering if there are any other women who have experienced the same reaction to their body. Kindly feel free to call me or email me with any answers. I am trying to reach my primary physician who is currently booked till February.
29 2021-03-15 vaginal haemorrhage Immediately following vaccination, started having itchy tongue, ears and mouth. Rash emerged on lef... Read more
Immediately following vaccination, started having itchy tongue, ears and mouth. Rash emerged on left chest and shoulder with muscle pain. Left arm became numb, rash at injections site, migraine, numb lips and mouth. Persisted and progressed to vomiting and diarrhea, tachycardia and tachypnea. On 1/14, petechiae around both eyes, widespread muscle and joint pain, tachycardia and tachypnea persist, unable to lift left arm, itchy face, nose and throat. 1/15 Tachycardia persists, migraine, diarrhea, sudden onset vaginal bleeding. 1/16 elevated blood pressure, tachycardia and tachypnea, found unresponsive in bed by my husband and taken to the emergency room.
29 2021-03-15 vaginal haemorrhage **8 weeks pregnant, estimated due date 10/25/2021. 2nd pregnancy ** I had vaginal spotting. I went ... Read more
**8 weeks pregnant, estimated due date 10/25/2021. 2nd pregnancy ** I had vaginal spotting. I went to see my Midwife, they had me do an ultrasound and drew some labs. I went back two weeks later and had blood drew again and everything came back normal. My Midwife told me she had a lot of people call and tell her they were spotting after there vaccine.
29 2021-03-21 sepsis, pneumonia 29 y/o female presented to hospital with complaints of SOB, skin flares secondary to history of disc... Read more
29 y/o female presented to hospital with complaints of SOB, skin flares secondary to history of discoid lupus, protracted vomiting, and joint pain. Side effects began 2 days after her 2nd COVID vaccine. Pt was transferred to hospital from another institution due to O2 sat in the 60s (room air), leukocytosis, and AKI. Patient was treated empirically for sepsis/pneumonia as well as lupus flare. She was also initiated on high dose steroids. Possible reaction to vaccine. Chest CT showed diffuse ground-glass opacities and no signs of pulmonary embolism. Pt was transferred from hospital to another facility given progressive organ failure, most specifically liver failure.
29 2021-04-01 anaphylactic reaction 2:50pm started with chest pressure and heaviness. 2:52pm shortness of breathe, honked and there was ... Read more
2:50pm started with chest pressure and heaviness. 2:52pm shortness of breathe, honked and there was a delay of paramedics. Took 2 pumps of inhaler. Did not work. EMT loaded me on the stretcher out of my car in the ambulance. Gave albuterol mix in nebulizer. Went into full anaphylaxis on the way to ER. 4 epi in the arm did not help 2 benedrylmshits to the arm did not help. I was on 5L oxygen until the epi was mixed with albuterol to pen airways. Anaphylactic episodes continued every 5 hours for 2 days, then became every 12 hours, then 24 hours, then 12 hours. Steroids, Claritin, antacid, albuterol epi mix have helped managed episodes. Still currently in the hospital.
29 2021-04-01 cardio-respiratory arrest, death Patient described myalgias, headache and dyspnea at ER visit on 4/1/21 at 2:37 am. Patient was disch... Read more
Patient described myalgias, headache and dyspnea at ER visit on 4/1/21 at 2:37 am. Patient was discharged. Patient returned the same day at 15:40 cyanotic, altered, hypoxic and hypotensive. The patient was found to have profound metabolic acidosis, liver failure, renal failure. She went into cardiopulmonary arrest, was revived, rearrested and died. Patient was treated for possible sepsis, shock, liver failure.
29 2021-04-13 pulmonary embolism, deep vein blood clot 4 days after vaccination woke up with severe foot Pain. 7 days later found out this was a superficia... Read more
4 days after vaccination woke up with severe foot Pain. 7 days later found out this was a superficial thrombophlebitis with a gastroc DVT and 4 right subsegmental pulmonary embolisms
29 2021-04-17 blood clot, brain sinus blood clot cerebral venous sinus thrombosis; CT scan that revealed the clot; horrible headache after intercours... Read more
cerebral venous sinus thrombosis; CT scan that revealed the clot; horrible headache after intercourse; vomiting; This is a spontaneous report from a contactable consumer (patient). A 29-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EP7534), second dose via an unspecified route of administration, administered in left arm on 25Mar2021 09:45 as single dose for COVID-19 immunisation. Patient was 29 year old at the time of vaccination. Medical history included asthma, gastrooesophageal reflux disease, peanut and treenut allergy, all from an unknown date. Patient had estrogen allergy. Patient was not diagnosed with COVID-19 Prior to or after the vaccination. Concomitant medications included cetirizine hydrochloride (ZYRTEC ALLERGY), medroxyprogesterone acetate (DEPO PROGESTIN), beclometasone dipropionate (QVAR), OMEPRAZOLE, SERTRALINE HYDROCHLORIDE, all taken on an unspecified date and for unknown indication. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient had her first dose of bnt162b2 on 04Mar20210 at 9:45 am in left arm for COVID-19 immunisation. On 28Mar2021 at 09:45 the patient was diagnosed with cerebral venous sinus thrombosis a few days after receiving the second dose of the vaccine. She had a horrible headache after intercourse, went to the ER after vomiting, and had a CT scan that revealed the clot. The patient was hospitalized for cerebral venous sinus thrombosis. The patient underwent lab tests and procedures which included computerised tomogram: revealed the clot. Patient received Heparin and Eliquis as treatment for the events. Outcome of the events was recovering. No follow-up attempts needed. No further information expected.
29 2021-04-17 blood clot, death Blood clot blocking blood flow to brain - 1st episode: ( 3/12/21) stabilized, minor limited movemen... Read more
Blood clot blocking blood flow to brain - 1st episode: ( 3/12/21) stabilized, minor limited movement left side - 2nd episode: (3/24/21) no blood flow to brain, death (maintained on life support for organ donation)
29 2021-04-17 vaginal haemorrhage 3/26/21- unexplained vaginal bleeding after 1st dose of vaccine. Not related to normal mentration. ... Read more
3/26/21- unexplained vaginal bleeding after 1st dose of vaccine. Not related to normal mentration. 4/16/21- unexplained appearances of bruises all over arms and legs 4/10/21- fell off bike and had a large bruise appear on right glute. Doesn't appear to be healing well. Still reddish in the middle and black/blue/purple
29 2021-04-20 vaginal haemorrhage 04/21/2021- ct 6-7 wks preg when rec'vd 1st dose Pfizer on 04/16/21, c/o 'little' stomach ache/ dizz... Read more
04/21/2021- ct 6-7 wks preg when rec'vd 1st dose Pfizer on 04/16/21, c/o 'little' stomach ache/ dizzy/myalgia that night. 04/17/21-8:30am , vag blding/'little' abd pain,- went to ER- U/S, bld work, urine test done-dx miscarriage. 4/18-4/20-pain in hip/waist, little nausea, today blding stopped, still a little nausea/ little pain in hip. EOC was approx 12/09/2021, ct has hx cervical medical issues this past year.
29 2021-04-21 grand mal seizure Per mother, patient had severe headache within 3 hours of administration, then had tonic clonic seiz... Read more
Per mother, patient had severe headache within 3 hours of administration, then had tonic clonic seizure the following morning requiring rescue medication
29 2021-04-21 excessive bleeding I had abdominal pain after being pregnant. Hospital - April 15 - ER for the pain and they found a h... Read more
I had abdominal pain after being pregnant. Hospital - April 15 - ER for the pain and they found a hemorrhage between uterus and placenta.
29 2021-04-22 pulmonary embolism Received vaccine 4/8/21. Presented to hospital 4/14 with worsening dyspnea and chest tightness. Foun... Read more
Received vaccine 4/8/21. Presented to hospital 4/14 with worsening dyspnea and chest tightness. Found to have bilateral pulmonary embolism. Unclear if the vaccine is a true precipitant here but wanted to report.
29 2021-04-22 vaginal haemorrhage My menstrual cycle came a lot heavier than it has ever been, including large blood clots. Additional... Read more
My menstrual cycle came a lot heavier than it has ever been, including large blood clots. Additionally, my premenstrual symptoms were much more painful and intense
29 2021-04-25 anaphylactic reaction Site: Itching at Injection Site-Mild, Systemic: Allergic: Anaphylaxis-Mild, Systemic: Allergic: Diff... Read more
Site: Itching at Injection Site-Mild, Systemic: Allergic: Anaphylaxis-Mild, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild
29 2021-04-25 anaphylactic reaction Systemic: Allergic: Anaphylaxis-Mild, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Aller... Read more
Systemic: Allergic: Anaphylaxis-Mild, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild
29 2021-04-26 deep vein blood clot Patient developed pain in left calf, bruising behind knee. Went to ER, ultrasound showed deep vein t... Read more
Patient developed pain in left calf, bruising behind knee. Went to ER, ultrasound showed deep vein thrombosis of gastrocnemius veins
29 2021-04-28 grand mal seizure Patient is a 29 yo F with PMHx of psoriasis who presented for dose #1 of Pfizer vaccine, she receive... Read more
Patient is a 29 yo F with PMHx of psoriasis who presented for dose #1 of Pfizer vaccine, she received her vaccine without issues and was being monitored for 15 minutes as recommended. Within her first 10 minutes of being monitored patient notified the staff that she felt warm, within one minute from her complaint of feeling warm she had a full general tonic clonic seizure in her chair for about 15 seconds with associated diaphoresis and thready pulse. Seizure activity broke spontaneously and pt was AO x 3. 911 was called immediately, she was transferred to our medical observation area for further monitoring and examination. Her initial vitals after seizure activity T: 97.5, HR 69, BP 130/77, 02: 98%, BS within first 10 minutes of monitor without food/water was 134. Exam: GEN: AO x 3 HENT: nc/at, anicteric sclera, EOMI CV: regular, nl s1, s2, no mrg PULM: clear bilaterally NEURO: grossly intact SKIN: clammy Upon further questioning pt states she had a similar response while in college to Yellow Fever vaccine but never had an evaluation. She has had vasovagal events with other vaccines and blood draws. She denies any neurological history other than seizure like activity with Yellow Fever vaccine. She states she had an aura with tunnel vision and feeling warm similar to when she had Yellow Fever vaccine. She denied any nausea, she was alert and oriented x 3 after resolution of seizure activity. She was transported to ED for further evaluation. Report was provided to at ED. Seen by Neuro on 4/23/21: Interim History: Patient is a 30 yr, right-handed woman with no significant medical history who is referred for evaluation of an episode of LOC. The episode occurred on 4/9/2021,10 minutes after receiving the 1st dose of the COVID-19 Pfizer vaccine. She reports feeing anxious after receiving the dose because of the history of having passed out after receiving vaccines. As with the previous events, she felt "hot and clammy" and had tunnel vision before losing consciousness for approximately 15 seconds. She was told that she "shook all over" for a few second. Upon regaining consciousness, she was oriented almost immediately and was not confused. The episode occurred while sitting. Patient reports a history of at least 5 syncopal events, since age 12 yr, with 4 of these occurring while sitting and 2 while standing. All of the evens have occurred either after receiving vaccines in 2016 or undergoing medical procedures. Two of the events also include shaking movements but none have been associated with tongue biting, urinary incontinence or post event confusion. She also reports a history of episodes of lightheadedness with postural changes but denies palpitations, CP or SOB. She has never had a neurological or cardiac evaluation. There is a history of a mild concussion while playing soccer. There is no history of CNS infections, febrile seizures or family history of neurological disease. Other Medications: ? adapalene, APPLY TOPICALLY NIGHTLY. APPLY A THIN LAYER AT NIGHT TO ACNE-PRONE AREAS. START EVERY -OTHER NIGHT AND ADVANCE AS TOLERATED ? clindamycin-benzoyl peroxide, APPLY TOPICALLY TWO TIMES A DAY Problems: has Vasovagal syncope on their problem list. Permission to discuss medical information with: Referring MD / Other MD(s): Current Providers PCP: APRN Referring Provider: APRN Care Team Provider: APRN Allergies: Allergies Allergen Reactions ? Pfizer Covid-19 Vaccine (Eua) [Covid-19 Vacc,Mrna(Pfizer)(Pf)] Seizures ? Bactrim [Sulfamethoxazole-Trimethoprim] Rash Medical History: has a past medical history of Psoriasis and Vasovagal syncope. Psychiatric History: none Family History: family history includes Depression in her brother; Heart murmur in her mother; Hypertension in her father. Social History: Social History Tobacco Use ? Smoking status: Never Smoker ? Smokeless tobacco: Never Used Substance Use Topics ? Alcohol use: Yes Alcohol/week: 0.0 - 2.0 standard drinks Review of Systems: ROS Objective: BP (!) 166/99 | Pulse (!) 105 | Temp 97.7 °F (36.5 °C) | Resp 14 | Ht 5' 7" (1.702 m) | Wt 56.7 kg | SpO2 99% | BMI 19.58 kg/m² The BP obtained after the consultation was 145/89 Neurologic Exam Physical Exam General: well appearing, well nourished, no distress, normal affect, cooperative. No rashes or skin lesions. Peripheral pulses intact throughout. Mental Status: Orientation: Alert, oriented to time, place and person. Memory: Remote and delayed recall intact.. Language: Speech fluent. Able to name, repeat and follow three step commands. CN: II: Full visual fields, fundi normal, PERRL. III, IV, VI: EOMs full, no nystagmus. V, VII: Facial sensation and movement intact. VIII: Hearing intact. IX, X: Palate elevates normally. XI: Normal. XII: Tongue midline. Motor: Normal bulk and tone. 5/5 power throughout. No pronator drift. FFMs quick and accurate bilaterally. Coordination: Normal FTN. No tremor. Sensation intact to light touch in all 4. Reflexes: 3/4 and symmetric throughout with downgoing toes. Gait: Normal, including tandem Romberg: Negative Assessment Patient is a 30 yr old woman with a recent episode of LOC that is consistent with convulsive syncope, despite occurring while sitting, 10 minutes after receiving the first dose of the COVID-19 vaccines. She has a history of similar episodes occurring after vaccinations or medical procedures. She reports episodes of pre-syncope and postural lightheadedness. She does not have risk factors for epilepsy and the episodes have an atypical duration for convulsive seizures. In my opinion, the recent event is not an allergic reaction to the vaccine and there is no contraindication for receiving the 2nd dose. Plan: I suggested taking lorazepam 1 mg prior to getting the 2nd dose of the COVID vaccine and to consider consultation with a cardiologist at some future time (but not required prior to obtaining the 2nd dose). I did not recommend an EEG or brain MRI scan. Follow-up will be on a PRN bases.
29 2021-04-29 pneumonia URI, bronchitis, bronchiolitis, allergic rhinitis, atypical pneumonia, community-acquired pneumonia,... Read more
URI, bronchitis, bronchiolitis, allergic rhinitis, atypical pneumonia, community-acquired pneumonia, asthma exacerbation, COPD exacerbation
29 2021-04-30 vaginal haemorrhage Heavy bleeding and extremely painful menstrual cramps during next menstrual cycle following second d... Read more
Heavy bleeding and extremely painful menstrual cramps during next menstrual cycle following second dose.
29 2021-05-02 vaginal haemorrhage Abnormal Vaginal spotting outside of mensural window. Currently on day 3 of consistent light spottin... Read more
Abnormal Vaginal spotting outside of mensural window. Currently on day 3 of consistent light spotting
29 2021-05-06 pulmonary embolism Headache Congestion or running nose New loss of taste or smell Dx Cough ? Shortness of Breath FATI... Read more
Headache Congestion or running nose New loss of taste or smell Dx Cough ? Shortness of Breath FATIGUE FEVER
29 2021-05-07 cerebrovascular accident, blood clot Blood clot on the cerebellum that caused a stroke; Blood clot on the cerebellum that caused a strok... Read more
Blood clot on the cerebellum that caused a stroke; Blood clot on the cerebellum that caused a stroke; This is a spontaneous report from a contactable consumer (patient). A 29-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EW0167), first dose via an unspecified route of administration, administered in Arm Left on 30Apr2021 11:30 (at 29 years old,(not pregnant), single dose for covid-19 immunisation. The patient's medical history was not reported. The patient's concomitant medication included an unspecified vitamin. The patient previously took ibuprofen and experienced Ibuprofen drug allergy. On 02May2021 08:30, patient experienced a Blood clot on the cerebellum that caused a stroke. The outcome of the events was recovering. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The adverse event resulted in visit to Emergency room/department or urgent care. Treatment received for the adverse event was Blood clot meds. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19 (02May2021), negative for swab test. Events caused 3 days of hospitalization. Information on Lot/Batch number was available. Additional information has been requested.
29 2021-05-07 pulmonary embolism Presented to hospital 14Apr2021 with dyspnea and found to have bilateral pulmonary Embolism.; Presen... Read more
Presented to hospital 14Apr2021 with dyspnea and found to have bilateral pulmonary Embolism.; Presented to hospital 14Apr2021 with dyspnea and found to have bilateral pulmonary Embolism.; This is a spontaneous report from a contactable physician. A 29-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided), intramuscular first dose on 08Apr2021 at single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was not pregnant at time of vaccination. The patient was presented to hospital on 14Apr2021 (also reported on 04Jan2021) with dyspnea and found to have bilateral pulmonary Embolism. The event caused hospitalization on 14Apr2021. The patient was treated with Anticoagulation. The patient underwent lab tests and procedures which included Nasal Swab: negative on 14Apr2021. The outcome of the events was recovered. Information on the lot/batch number has been requested.
29 2021-05-11 pulmonary embolism Pulmonary embolisms. Many clots in the lungs. Currently being treated with blood thinners. Developed... Read more
Pulmonary embolisms. Many clots in the lungs. Currently being treated with blood thinners. Developed a major cough and pain in my back, shoulder and chest. About 6 days of experiencing this I went to the ER and they found I had clotting in my lungs.
29 2021-05-11 blood clot Calf muscle pain since 1 week. Clots upto 1 inch near the knee area. Observed on both legs; Calf mus... Read more
Calf muscle pain since 1 week. Clots upto 1 inch near the knee area. Observed on both legs; Calf muscle pain since 1 week. Clots upto 1 inch near the knee area. Observed on both legs; This is a spontaneous report from a contactable consumer. A 29-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 21Apr2021 16:00 (Batch/Lot number was not reported) as 2ND DOSE, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received BNT162B2 for COVID-19 immunization on 31Mar2021 (Lot unknown=True, Lot unknown reason=Unable to locate or read the details, Administration date=31Mar2021, Administration time=02:00 PM, Dose number=1, Vaccine location=Left arm, No reaction.) On 24Apr2021, Calf muscle pain since 1 week. Clots upto 1 inch near the knee area. Observed on both legs. The patient did not receive treatment for the events. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
29 2021-05-12 blood clot Blood clotting with spotting and pain; Irregular period; Pain in lower left side of abdomen; Blood c... Read more
Blood clotting with spotting and pain; Irregular period; Pain in lower left side of abdomen; Blood clotting with spotting and pain; This is a spontaneous report from a contactable consumer (patient). A 29-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 24Mar2021 10:00 (Batch/Lot number was not reported) as single dose for covid-19 immunization. Facility where the most recent COVID-19 vaccine was administered was Other. Medical history included none. The patient's concomitant medications were none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine or any other medications the patient received within 2 weeks of vaccination. The patient previously received the first dose on 05Mar2021 08:00 as single dose for covid-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced irregular period after second dose, pain in lower left side of abdomen and blood clotting with spotting and pain on 16Apr2021 12:00. The outcome of the events was unknown. No treatment received for the events. Information related lot/batch number has been requested.
29 2021-05-19 cerebrovascular accident stroke-like symptoms; not being able to see out of my left eye; the left side of my body was numb; p... Read more
stroke-like symptoms; not being able to see out of my left eye; the left side of my body was numb; pounding headache on the left side of their head; shooting pain up and down my neck; could barely turn my head with shooting pain down my body; shingles; migraines; This is a spontaneous report from a contactable consumer (patient). A 29-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (at 29 years of age), via an unspecified route of administration, administered in arm left on 22Apr2021 10:15 (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for COVID-19 immunisation. Medical history included autoimmune disorder from an unknown date and unknown if ongoing. Concomitant medication included levothyroxine taken for an unspecified indication, start and stop date were not reported. The patient was not pregnant. The patient had no known allergies. She was not diagnosed with COVID-19 prior to vaccination. She has not been tested for COVID-19 since the vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that the patient had stroke-like symptoms, not being able to see out of her left eye, the left side of her body was numb, and she a pounding headache on the left side of their head. Upon being checked into the ER, she was immediately put on stroke alert. After a CAT-Scan and two MRIs, blood clots were ruled out. She stayed under close watch, and an IV was administered. All her blood work numbers checked out and the doctors were puzzled. After three to four hours, the symptoms reduced. After ten hours, they were almost gone. She went home and didn't have any more complications that day. Fast forward to the 1st, new symptoms. She now has shooting pain up and down her neck. At first, she thought she strained her neck, but the next day she could barely turn her head with shooting pain down her body. This morning they went to their PPC to get checked out. Luckily, a diagnosis was given. She had developed shingles. The events started on 26Apr2021 10:00 AM. The events resulted to Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The patient was hospitalized for the events. Therapeutic measures were taken as a result of the events. She was given IV for migraines but it did nothing. The outcome of the events was recovered with lasting effects. Information on the lot/batch number has been requested.
29 2021-05-23 anaphylactic reaction within 15-30min of getting the vaccine the rashes and hives began to appear on my arms and shortly a... Read more
within 15-30min of getting the vaccine the rashes and hives began to appear on my arms and shortly after my throat got tight and hard to breath. Went to the ER were they treated me. They determined it was anaphylaxis and prescribed an Epipen.
29 2021-05-25 cerebrovascular accident Branch retinal artery occlusion (stroke) causing vision loss Currently taking aspirin and Lipitor ... Read more
Branch retinal artery occlusion (stroke) causing vision loss Currently taking aspirin and Lipitor as prophylactic measure while continuing to undergo extensive testing
29 2021-05-25 vaginal haemorrhage experienced bleeding last night, when she is not even scheduled to have her menstruation yet; Vagina... Read more
experienced bleeding last night, when she is not even scheduled to have her menstruation yet; Vaginal bleeding; dizziness; waves of nausea; tiredness; chills; feels hot and cold a lot/hot flashes or cold a lot; had cramps similar to that of menstrual cramps; felt like she had a fever; This is a spontaneous report from a contactable consumer (Patient). A 29 years old female patient received the 1st dose of BNT162B2 (the Pfizer-BioNTech Covid-19 Vaccine, Batch/lot number: ER8729) on 09Apr2021 on left arm at single dose for covid-19 immunization. Medical history was not reported. She took a lot of medications, antidepressants and antianxiety meds, states she told the facility where she got the vaccine about these. Until now, she said she is still experiencing dizziness, waves of nausea, tiredness, and chills. She said she feels hot and cold a lot. Last night (14Apr2021), she said she had cramps similar to that of menstrual cramps. She said she has not had cramps ever since she started being on an Intrauterine Device (IUD) and birth control. Consumer also said that she experienced Vaginal bleeding last night (14Apr2021), when she is not even scheduled to have her menstruation yet. She wants to know if this is a normal reaction to the vaccine, and if it is normal that she is still having the symptoms even after almost 7 days since receiving the vaccine. Caller states she gets dizzy a lot, waves of nausea, and felt like she had a fever, hot flashes or cold a lot. Had to call out of work on the weekend. Last night was really weird for her, was having cramps, like menstrual cramps, has an IUD and takes birth control and went to the bathroom and she was bleeding, even if she was supposed to have her period it wouldn't be the time she was supposed to be having it, called her Gynocologist to let them know. Dizziness gets worse during the day, nausea comes in waves, tries to sleep through the day, the more she sleeps the better she feels. Does not know if this is an allergic reaction. Outcome of the event was unknown. No follow-up attempts are possible. No further information is expected.
29 2021-05-27 deep vein blood clot Patient was found unresponsive at home on 5/22, admitted to another institution, found to be in DKA,... Read more
Patient was found unresponsive at home on 5/22, admitted to another institution, found to be in DKA, multisystem organ failure (renal failure, liver failure), new R femoral DVT, elevation of ferritin, LDH and CRP. Over the course, platelet count continues to drop while on anticoagulation, and continued progression of thrombi, and transferred to our institution for further workup, including hepatic failure, concern for HLH and Castro trophic antiphospholipid syndrome. Based on chart review, patient had non-specific symptoms for a few weeks prior to the presentation, including GI distress, dysphagia and neck/sinus pain. CTH done with cerebral edema but not intracranial venous thrombosis. CT chest and abdomen with no PE, but presence of R popliteal vein thrombus, and portal vein thrombus. Heparin Ab (PF4 -ELISA test) was negative (at both referring hospital and current hospital). Serotonin release assay is pending at the time of report. While the symptoms are not consistent VITT that were reported (Heparin ab negative, received mRNA vaccines), however this possibility cannot be ruled out. IVIG was started on 5/27 - 5/28 to treat empirically for concern for heparin induced thrombocytopenia vs VITT.
29 2021-05-27 excessive bleeding bleeding; headache; sore throat; cough; dizziness; tiredness; This is a spontaneous report received ... Read more
bleeding; headache; sore throat; cough; dizziness; tiredness; This is a spontaneous report received from a contactable consumer (patient). A 29-year-old female patient received the first dose of BNT162B2, via an unspecified route of administration in right arm on 05May2021 12:15 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced bleeding, headache, sore throat, cough, dizziness, and tiredness on 08May2021. Events were resulted in emergency room/department or urgent care. Treatments included pills and zirup. Nasal swab on 12May2021: Negative. Outcome of the events was resolving. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
29 2021-06-07 excessive bleeding This is a spontaneous report from a non-contactable consumer. A 29-years-old female patient receiv... Read more
This is a spontaneous report from a non-contactable consumer. A 29-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Left Arm on 17Apr2021 09:15 (Batch/Lot Number: EW0169) as 1ST DOSE, SINGLE (at the age of 29 years) for covid-19 immunisation. Medical history included gastritis from an unknown date and unknown if ongoing and covid-19 from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient experienced hemorrhages for more than 1 month on 19Apr2021 with outcome of not recovered, allergies throughout the whole body on 19Apr2021 with outcome of not recovered, body pain on 19Apr2021 with outcome of not recovered, bad breathing on 19Apr2021 with outcome of not recovered and fever at night on 19Apr2021 with outcome of not recovered. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient has not been tested for COVID 19 since the vaccination. No follow-up attempts are possible. No further information is expected.
29 2021-06-10 cerebrovascular accident Branch retinal artery occlusion (stroke); Branch retinal artery occlusion (stroke); This is a sponta... Read more
Branch retinal artery occlusion (stroke); Branch retinal artery occlusion (stroke); This is a spontaneous report from a contactable consumer (patient). A 29-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0171 and expiration date not provided), via an unspecified route of administration, in left arm, on 25Apr2021 12:45 (at the age of 29-year-old, not pregnant), at single dose, for COVID-19 immunization. Medical history reported as "none". Patient had no known allergies. Patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not receive any other medications within 2 weeks of vaccination. The patient experienced branch retinal artery occlusion (stroke) on 05May2021 16:15. Events resulted in doctor or other healthcare professional office/clinic visit emergency room/department or urgent care, disability or permanent damage. The patient underwent lab tests and procedures, which included COVID-19 test (Nasal Swab) was negative on 10May2021, and negative on 18May2021. Therapeutic measures were taken as a result of events and included treatment with acetylsalicylic acid (ASPIRIN), atorvastatin calcium (LIPITOR) and ongoing tests/consultations. The outcome of the events was not recovered.
29 2021-06-14 anaphylactic reaction 5/4-5/6: PRURITIC RASH DEVELOPED AT INJECTION SITE 5/7 - HIVES STARTED, TREATED WITH PREDISONE 50 mg... Read more
5/4-5/6: PRURITIC RASH DEVELOPED AT INJECTION SITE 5/7 - HIVES STARTED, TREATED WITH PREDISONE 50 mg qd x 5 days 5/8-5/10: HIVES, SWELLING ON UPPER & LOWER LIPS, SWELLING OF EYES 5/10 - HIVES, SWELLING OF EYES/MOUTH, SHORTNESS OF BREATH, TIGHTNESS AROUND CHEST; HIGH BLOOD PRESSUE,SWELLING IN POSTERIOR OROPHARYNX, SWELLING ON UPPER & LOWER LIPS, URTICARIA & MULTIPLE PAPULES ON BOTH ARMS, TORSO & BOTH LEGS -> WENT TO URGENT CARE WHERE WAS GIVEN AN EPIPEN THEN 911 CALLED &TAKEN TO THE HOSPITAL FOR FURTHER OBSERVATION OF ANAPHYLAXIS 5/11-5/15 - BRUISING; TAKING PREDISONE, BENADRYL, PEPCID AND CLARATIN. SYMPTOMS SUBSIDED DURING COURSE OF TREATMENT 5/26 - HIVES, SWELLING OF EYES/MOUTH, SHORTNESS OF BREATH, TIGHTNESS AROUND CHEST -> EPIPEN INJECTION ADMINISTERED 6/6 - HIVES AROUND ANKLE AREA AND SWOLLEN FEET/ANKLES 6/12 - WORST REACTION YET, HIVES, EYES SWOLLEN SHUT, SHORTNESS OF BREATH AND LIPS SWOLLEN -> EPIPEN INJECTION ADMINISTERED; LINGERING SIDE EFFECTS (SWOLLEN EYES, RASH HAVE NOT SUBSIDED COMPLETELY AS OF TODAY) - CONTINUING BANOPHREN AND CLARITIN TREATMENT DAILY
29 2021-06-16 blood clot blood clot; high levels of d dimer in blood; very dizzy; can barely walk; migraine; fatigue; chills;... Read more
blood clot; high levels of d dimer in blood; very dizzy; can barely walk; migraine; fatigue; chills; temperature changes; pain in body switching from left to right and vice verse; chest pain; shallow breathing; This is a spontaneous report from a non-contactable consumer. This consumer (patient) reported that a 29-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 29-years, via an unspecified route of administration on 20May2021 at single dose for COVID-19 immunization, in hospital. Medical history was not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at time of vaccination. Concomitant medications included gabapentin, lorazepam (ATIVAN), norethisterone (NORETHINDRONE), omeprazole. The patient previously received all antibiotics except for doxycycline. The patient went to hospital to check for blood clot; high levels of d dimer in blood; very dizzy, can barely walk; migraine; fatigue; chills and temperature changes; pain in body switching from left to right and vice verse; chest pain and shallow breathing; serious side effects 1 week later. The events occurred on 27May2021. The adverse events resulted in doctor or other healthcare professional office/clinic visit, resulted in emergency room/department or urgent care. Outcome of the events was not recovered/not resolved. Since the vaccination, the patient has not been tested for COVID-19. No follow-up attempts are possible; information about lot/batch number cannot be obtained
29 2021-06-17 anaphylactic reaction anaphylactic reaction; This is a spontaneous report from a contactable pharmacist. This Pharmacist r... Read more
anaphylactic reaction; This is a spontaneous report from a contactable pharmacist. This Pharmacist reported for two patients. This is the second of two reports regards to a female patient. A 29-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscular, administered in Deltoid Left on 02Jun2021 (Batch/Lot Number: EW0178; Expiration Date: Aug2021) at the age of 29-year-old, as 1st dose, single for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications was reported as taking other medication (unspecified). The patient experienced anaphylactic reaction on 02Jun2021. They took her to the hospital. It was reported the vaccine shot was between 11:30 and 12:00 in the morning. The patient experienced anaphylactic reaction literally like may be within 5 minutes after taking the shot. So its again 11:30 or 12:00. The outcome of event was unknown. Information on Lot/Batch number is available; Further information has been requested.; Sender's Comments: Based on the plausible temporal relationship and known drug safety profile, a possible causal relationship between the event Anaphylactic reaction and suspect drug BNT162B2 cannot be excluded.,Linked Report(s) : US-PFIZER INC-2021641495 same reporter, product, different patient and similar events.
29 2021-06-23 bleeding on surface of brain Patient experienced a thunderclap headache during a workout at about 6:00pm on 05/05/2021. She also ... Read more
Patient experienced a thunderclap headache during a workout at about 6:00pm on 05/05/2021. She also had nausea, light sensitivity, and neck stiffness. She went to urgent care around 8:00pm and received a shot of toradol for suspected migraine. When the headache didn't resolve completely, she went to the emergency room around 11pm. On 05/06 around 5:30am, a CT scan revealed a subarachnoid hemorrhage over the right sylvian fissure. A CTA of the head and neck immediately following showed no aneurysm or AVM. The patient was admitted, and underwent a catheter angiogram later that afternoon, which also showed no aneurysm or AVM. She was admitted to the NeuroICU for one week, took nimodipine and keppra as prescribed, underwent transcranial dopplers daily to check for vasospasm, and did not develop any major complications. Patient developed worsening pain near the tailbone while hospitalized, which was attributed to nerve pain from blood in the subarachnoid space. On 05/12/2021, the patient underwent a second catheter angiogram, which also showed no aneurysm, AVM, or abnormality. The patient was discharged home on 05/13/2021, with followup with neurosurgeon for a likely third cerebral catheter angiogram.
29 2021-06-25 blood clot in lung appear blood clot in my lungs; This is a spontaneous report from a contactable consumer (patient her... Read more
appear blood clot in my lungs; This is a spontaneous report from a contactable consumer (patient herself). A 29-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in left arm on 14May2021 (Batch/Lot Number: EW0172) (at the age of 29-years-old) as second dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Prior to vaccination, patient was not diagnosed with COVID-19. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was previously administered with first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: ER8731) on 23Apr2021 (at the age of 29-years-old) in the left arm for COVID-19 immunisation. On 15May2021, patient reported appearance of blood clot in her lungs. The event resulted in Emergency room/department or urgent care. The patient was given Eliquis as treatment for the event. The event was assessed as non-serious. Outcome of event was unknown. Since the vaccination, patient has been tested for COVID-19.
29 2021-06-27 blood clot Right arm began to have moderate pain and swelling, a large mass developed in the bicep area and arm... Read more
Right arm began to have moderate pain and swelling, a large mass developed in the bicep area and arm became incredibly tight. Started to get heart burn that would not go away with any type of relief. Went to the emergency department and was scanned for a blood clots. Ultrasound and X-rays showed only one large clot in right arm, was superficial.
29 2021-06-30 low blood platelet count Early AM 6/16/21: I began noticing petechia on my feet. A bloody sore developed on my lip and my mou... Read more
Early AM 6/16/21: I began noticing petechia on my feet. A bloody sore developed on my lip and my mouth was bleeding a little. Late afternoon 6/16/21: The petechia moved up my legs and the bleeding in my mouth hadn't stopped. I was incredibly tired. 6/17/21: The bleeding in mouth worsened. I was having to walk around with gauze in my mouth to control the gum bleeding. More big, black, bloody sores developed in my mouth. The petechia was now covering most my body, including inside my ears and mouth. 6/18/21: I was no longer able to eat without sever pain. I was bleeding profusely when I urinated. Petechia had moved into my eyes. I was incredibly fatigued and I had a migraine that was progressively getting worse over the past 3 days. My mother rushed me to the ER at noon. I was admitted to the hospital within 30 minutes of arriving. They began running tests immediately. I lost track of the amount of blood they took to test. I received a CT Scan and MRI to ensure I wasn't bleeding from my brain or had a stroke. By 7:30PM I was in the main hospital. I was given a COVID test at this time. They informed me that my platelet count had dropped to 5,000 and they would be giving me bagged platelets(1 bag) and IVIG (8 glass bottles). 6/19/21: I was woken up around 6:30AM and given a dose of Dexamethasone and B12. They drew more blood a couple hours later. By noon the doctor informed me that my platelet count had increased to 9,000. That evening I had another dose of 7 glass bottles of IVIG. 6/20/21:I was woken up around 6:30AM and given a dose of Dexamethasone and B12. They drew more blood a couple hours later. By noon the doctor informed me that my platelet count had increased to 125,000. 6/21/21: I was released from the hospital due to my platelet count continuing to go up. It was up to 400,000. I was given a prescription for one more dose of Dexamethasone, Sumatriptan for my migraines and told to continue taking B12. 7/1/21: Had a follow up appointment with the hematologist from the hospital and I was informed my platelet count was okay but that I am now anemic.
29 2021-07-02 ischaemic stroke Patient complained of left arm soreness initially at the vaccination site. On 6/30 she woke up from ... Read more
Patient complained of left arm soreness initially at the vaccination site. On 6/30 she woke up from a nap and noticed her left arm was numb and she was unable to move. Went to acute care facility where had acute onset quadriplegia. Was transferred to local hospital ED where CT scan or cervical spine and MRI C spine were done with concern for acute spinal cord infarct. Patient was subsequently transferred to hospital for further care. At hospital her BP was raised to increase blood flow to the spinal cord. Also lumbar drain was inserted for increased cord perfusion. Despite attempt to increase cord perfusion patients symptoms did not improve
29 2021-07-07 fluid around the heart Experienced fatigue and diarrhea 2 days after receiving vaccine. Continued to experience diarrhea sy... Read more
Experienced fatigue and diarrhea 2 days after receiving vaccine. Continued to experience diarrhea symptoms for 7 days (intermittently for a month after). Experienced dizziness, shortness of breath and chest pain on April 26, 13 days after receiving vaccine. Went to ER, EKG was clear. Blood work showed elevated D-dimer levels and CT scan of the chest was done with no abnormalities found. Experienced dizziness, shortness of breath and chest pain 3 times after ER visit. Echo and heart monitor was ordered by cardiologist, a month later. Findings showed irregular heartbeat and trace pericardial effusion.
29 2021-07-12 low blood platelet count The adverse reaction was with my son who is breast fed not with my wife. On June 28th we took our s... Read more
The adverse reaction was with my son who is breast fed not with my wife. On June 28th we took our son to the doctors for a normal 6 month visit and showed them some of the bruises he had on his arms caused by our daughter grabbing his arms. They asked normal questions about any bleeding he may have had from circumcision or past shots and we told them none. They said the bruising is okay but to be careful with how our daughter plays with him. He got his 6 month shots and we went home. My wife noticed that he was bleeding through the bandaids and his shorts so we went back to the doctors office. They were now concerned and sent us to Hospital. Hospital did extensive blood work and ruled out things like Leukemia and things like lupus for now since his red and white blood cell count was normal. However his Platelet Count is extremely low. They think he was experiencing ITP or Immune Thrombocytopenic Purpura. His platelet count was 5 and should be between 159-350 His body thinks he has a virus and is attacking his platelets. They treated him with immunoglobulins. Update on Alek. A normal platelet count should be between 159-350 was 5. The infusion of immunoglobulins he got last night worked. He got his results back and they were good news. He increase to 132 and then 218. The hope is that he will maintain or increase the platelet count from here on out. He?s had a few blood tests last week and his count is very high and hopefully will level out. My concern is this: My wife had her 2nd Pfizer shot on June 9th. We started noticing the bruising on or around the 12th or 13th. I?ve asked at least a dozen doctors and nurses if the virus that my son?s immune system was fighting could have been caused by my wife?s 2nd Pfizer vaccine since she breast feeds. No one can give me an answer nor will they do any testing. Not to mention my son is a COVID baby. My wife and I both had COVID while she was pregnant with him. If anything you would think someone would care enough to at least test him for COVID or the antibodies. But no. Everyone just blows me off. Maybe what happened to him and his case could save another little babies life. If it wasn?t for the bruising on his arms caused by my daughter who knows what could have happened. Some doctors say he could have had a brain bleed and died.
29 2021-07-19 pulmonary embolism I received my 2nd dose of Pfizer on 4/17/21. I felt completely fine all day Saturday, and just had t... Read more
I received my 2nd dose of Pfizer on 4/17/21. I felt completely fine all day Saturday, and just had the normal chills & typical high-grade fever that evening. The next morning, I started to feel a little crummy, then Sunday evening, I started to feel like my chest was tightening. I wanted to avoid going to the doctor, so I waited to see if it would stop. Between 2AM - 5AM on Sunday, my symptoms severely worsened. The only way I can describe it is what I imagine a heart attack feeling like. I waited until 8AM to go to the urgent care center?I still felt chest pain, but not that I was in a life or death situation. I figured it was a vaccine side-effect and that I would be fine. The urgent care center wouldn't see me because of my high temperature, and the nurse on the phone recommended I go straight to the Emergency Room. By the time I arrived at the ER, I was feeling better, but they still wanted to run some tests on me. Doctor helped take care of me and talked me through everything. They weren't quite sure what was going on?they suspected it was a pulmonary embolism, so they ran multiple tests. The tests came back fine, so they discharged me and told me to keep taking Ibuprofen and to follow up with my primary care physician that week. I went home that day, and started to feel better. By the next day, I was back at work and felt totally fine again! I followed up with my PC doc that week, and everything looked completely normal. As more studies & research has been conducted over the past few months with the COVID-19 vaccine, I am 90% sure that I suffered from myocarditis?a new side effect mostly found in younger children. Everything described in this article sounds like my symptoms and I wanted to share my experience to help the CDC collect more data and information.
29 2021-07-21 blood clot My last period lasted for three weeks with a lot of blood clots; My last period lasted for three wee... Read more
My last period lasted for three weeks with a lot of blood clots; My last period lasted for three weeks with a lot of blood clots/Period is also very runny and watery. Bleeding through many pads per hour.; Periods after covid are irregular; This is a spontaneous report from a contactable consumer (Patient herself). A 29-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration in Arm Right on 04Apr2021 12:00 (at the age of 29-years-old) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and she did not receive any other medications within 2 weeks of vaccination. Prior and since to the vaccination the patient did not diagnosed with COVID-19. On an unspecified date the patient reported that her periods after COVID are irregular. Her last period lasted for three weeks with a lot of blood clots. Some blood clots were the about the size of a golf ball. Period is also very runny and watery. Bleeding through many pads per hour. Prolonged hospitalization reported as No. The treatment received reported as no. Outcome of events was not recovered.
30 2021-01-13 anaphylactic reaction Itching, facial tightness, flushing, throat changes. Was given Epi x 1, Bendaryl x 1 and Hospital Ra... Read more
Itching, facial tightness, flushing, throat changes. Was given Epi x 1, Bendaryl x 1 and Hospital Rapid Response called and she was brought to ED. At ED, evaluation done, pt stable, felt to be likely anxiety/panic attack as cause of symptoms, and low likelihood of anaphylaxis. Pt was given rx for Epi pen to keep on hand just in case.
30 2021-01-15 systemic inflammatory response syndrome Met SIRS criteria, PVCs every 10 minutes after
30 2021-02-02 pneumonia Bilobular Pneumonia was developed between 1st and second shot.
30 2021-02-03 anaphylactic reaction Received initial COVID vaccine at about 1200 today. About ten minutes later started to feeling burni... Read more
Received initial COVID vaccine at about 1200 today. About ten minutes later started to feeling burning CP, SOB, feeling of tongue swelling, and had a loose stool. Now feeling lightheaded. Was feeling fine prior to the immunization. Anxiety. Anaphylaxis. 30 yo female known hx of allergic reaction/atopy to vaccines presented with anaphylaxis approx 10 minutes after the covid-19 Pfizer vaccine.
30 2021-02-03 anaphylactic reaction anaphylactic reaction; had a fever of 100.8; This is a spontaneous report from a nurse reporting fo... Read more
anaphylactic reaction; had a fever of 100.8; This is a spontaneous report from a nurse reporting for herself. A 30-years-old female patient received the first dose of bnt162b2 (BNT162B2; Lot # EL0140) vaccine , via an unspecified route of administration on 13Jan2021 at single dose for Covid-19 prophylaxis . Medical history included ongoing asthma Diagnosed when she was a child , seasonal allergy , food allergy , contrast media allergy (gadolinium). There were no concomitant medications. The patient experienced anaphylactic reaction on 13Jan2021 with outcome of recovered , had a fever of 100.8 on 13Jan2021 with outcome of recovered. The patient underwent lab tests and procedures which included allergy test: unknown results on Jan2021 , body temperature: 100.8 on 13Jan2021. The reaction began 28 minutes later. She says she started to get jumpy, her hands swelled and got itchy. She couldn't bend her hands, they were so swollen that she couldn't bend them. Her legs were shaking. Then saline and eventually her mouth started to get numb and they used an Epi pen twice. Her throat never closed, she thinks it did not close because the Epi pen was done twice, She had 2 masks on she cannot say for sure if she had trouble breathing but her mouth began to get dry and tingly and she started to no be able to feel her mouth. She says she would says it was resolved completely the next day. The patient also received Decadron and Benadryl. The reporter would say the event were life threatening because they treat it that way due to anaphylaxis precautions. Follow up information has been requested.
30 2021-02-08 low platelet count Approximately 12 days after vaccination co began to have fatigue, weakness, Pancytopenia Recent... Read more
Approximately 12 days after vaccination co began to have fatigue, weakness, Pancytopenia Recent hospitalization which involved initial presentation at hospital on AK 12/29, and then again on 12/30, after eval on 12/30 was then transferred to another hospital, and later transferred where she later recovered and was discharged. She was initially very ill and was thought to have sepsis due to fever/initial presentation/clinical picture, also had lab abnormalities including thrombocytopenia. These things necessitated transfer. While at hospital, hematology was consulted. Decision was made to transfer due to concern for DIC/possibility of leukemia. Also there was concern for C Diff, treatment was given for this. While in hospital, she underwent further testing on blood samples which revealed no evidence for malignancy, also bone marrow biopsy was performed. While there, DIC labs were trended/began to improve. Discharged on 1/5/21. Had f/u with hematology @ hospital on 1/12/21. No reason has been found as of yet as to why she became ill. Per discharge note it's thought it could have been viral in nature, or possibly related to supplement use. Will f/u with heme in early Feb. Of note, she does report getting her first dose of pfizer covid vaccine on 12/17/20, she reports concern that this could have played a part in her illness. She states this was the only new/out of the ordinary thing that she can remember recently, regarding her medical hx, prior to recent acute illness/hospitalization. Requests I reach out to inquire how she can file a report with Pfizer or CDC
30 2021-02-09 anaphylactic reaction Anaphylaxis; persistent throat swelling; nasopharynx/oropharynx edema; difficulty breathing; difficu... Read more
Anaphylaxis; persistent throat swelling; nasopharynx/oropharynx edema; difficulty breathing; difficulty swallowing; choking sensation; This is a spontaneous report from a contactable Physician. A 30-year-old female patient (pregnant: No) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via unspecified route of administration on 14Jan2021 at single dose for COVID-19 immunization. The relevant medical history included known allergies: sulfa from an unspecified date. Concomitant medications were not reported. The patient experienced anaphylaxis: followed by persistent throat swelling, nasopharynx, oropharynx edema causing recurrent difficulty breathing, choking sensation and difficulty swallowing on 14Jan2021. The events resulted in doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event). The patient underwent lab test included Covid which showed negative on an unspecified date post vaccination. The outcome of the events was unknown.; Sender's Comments: Based on a close chronological association a causal relationship between reported events and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
30 2021-02-15 vaginal haemorrhage More than normal vaginal discharge after the first dose of the vaccine. Bleeding from vagina (possib... Read more
More than normal vaginal discharge after the first dose of the vaccine. Bleeding from vagina (possible period) 2 days after the second dose on 2/12.
30 2021-02-18 anaphylactic reaction She is a nurse and received her vaccine outside at the Vaccine Site. She had an immediate reaction t... Read more
She is a nurse and received her vaccine outside at the Vaccine Site. She had an immediate reaction to her first dose of the Pfizer Covid vaccine with acute hives within 15 minutes on 12/26. She had hives on her neck, arms chest, headache arm pain and mild dizziness. Symptoms resolved with Benadryl She received her second dose of the Covid vaccine 12/26 with immediate symptoms within 30 minutes of respiratory symptoms, shortness of breath, hives, dizziness, fainting with treatment of epinephrine on site at the Vaccine Site by ambulance to the ER. She reports she was hypoxic with O2 sat 70 to 75%. Went to hospital and received 3 doses of epinephrine, IV Benadryl, IV fluids, Pepcid, and 7 days of prednisone. 1/26: c/o chest tightness had video visit with primarily MD, continued diphenhydramine and refer to allergy. She does have a history of vaccine reaction in the past to Gardasiln (contains polysorbate 80) given at age 16 with delayed hives 24 hours later. Allergist assessment: Covid vaccine 19 mRNA anaphylaxis with 2nd dose and acute hives with 1st dose of Pfizer vaccine S/p repeated doses of epipen With ongoing asthma, dizziness, light headed , nausea and fast heart rate 1.5 weeks after anaphylaxis but normotensive With prior history of delayed hives with gardisil --may be sensitive to polysorbate 80 in both vaccines. Added COVID vaccine to allergy list
30 2021-02-18 anaphylactic reaction Anaphylaxis
30 2021-02-21 anaphylactic reaction Fine for hour or so then began to lose voice slowly over the next few hours and cough. Shortness of ... Read more
Fine for hour or so then began to lose voice slowly over the next few hours and cough. Shortness of breath from simply walking around swelling of the glands and consul in the neck and throat
30 2021-03-04 anaphylactic reaction Mild anaphylaxis about 20 minutes after dose. Abrupt painful tightening of the throat, no real diffi... Read more
Mild anaphylaxis about 20 minutes after dose. Abrupt painful tightening of the throat, no real difficulty breathing. My face felt "buzzy" but didn't swell and I did not have significant itching. I have had similar reactions in the past to cleaning products and pesticides and usually take a benadryl, though I do carry an epipen and had one with me at the time. Instead of going back in the convention center for medical attention I took a benadryl and waited in the parking garage for about an hour and felt the throat restriction ease a bit. About 10 hours later around 8pm the tightness came back suddenly over about 10 minutes and I took another benadryl. The next morning around 7am I had one more round of tightening and took one more benadryl, and it stopped after that. I told my doctor about it a few days later.
30 2021-03-12 deep vein blood clot 4 days after my last vaccine I started getting really intense calf pain like a bad cramp. After the ... Read more
4 days after my last vaccine I started getting really intense calf pain like a bad cramp. After the pain just kept getting worse I ended up going to the ER on January 15th 2021. They did an ultrasound and found out I had a dvt. I was also experiencing horrible migraines since the 1st shot I also started seeing black spots in my vision. I also was having fevers and chills
30 2021-03-14 anaphylactic reaction Patient waited in pharmacy for 15 minutes after receiving vaccine and was fine. Approximately 30 min... Read more
Patient waited in pharmacy for 15 minutes after receiving vaccine and was fine. Approximately 30 minutes after administration she began experiencing throat tightness described by the patient to feel like an anaphylactic reaction. She immediately took oral Benadryl and returned to normal.
30 2021-03-15 anaphylactic reaction Pt had itchy throat, tight throat, sense of doom at 30 min obs mark. Was given EPI and transferred t... Read more
Pt had itchy throat, tight throat, sense of doom at 30 min obs mark. Was given EPI and transferred to local ED. Had rebound anaphylaxis days later (3 days after) resulting in 2nd ED trip.
30 2021-03-17 transient ischaemic attack TIA approximately 2 days later. PT had unilateral facial paralysis, dysarthria, and arm/leg paralysi... Read more
TIA approximately 2 days later. PT had unilateral facial paralysis, dysarthria, and arm/leg paralysis. Non-ambulatory, unable to use right arm or right legs. Could not lift. Admitted to hospital. CT scan negative for acute stroke. Pt had complete resolution of all symptoms with 6 hours of admission. Felt to represent TIA.
30 2021-03-18 anaphylactic reaction 1022 - Patient received her 1st Pfizer vaccine by RN. She noted a history of vasovagal syncope to n... Read more
1022 - Patient received her 1st Pfizer vaccine by RN. She noted a history of vasovagal syncope to needles in the past (did not seem like it was complete syncope to all needle sticks per RN). RN offered for her to lie down, but she said she felt ok sitting. She did not endorse any history of severe allergies or reactions to injectables in the past; she was asked the necessary questions prior to vaccination. We later learned she has Crohn?s and is on immunosuppressant Imuran for this disorder. 1023ish ? walked to checkout area 1025 - While sitting at the checkout registering for her second shot she started to feel faint and checkout staff called for help 1026 - RNs were getting the BP cuff on her. She appeared obtunded and slouching in her chair- eyes closed. Gentle sternal rub and she was able to open her eyes and tell us what her name was and ask to call her dad. BP 90/58. Cold cloths placed on her neck. Continuous pulse ox monitor placed, showing 99%. 1030 - Still drowsy and diaphoretic. Able to tell us that "she passes out when she gets shots" C/O nausea and vomited. Still in and out of awareness. NP is site coordinator is now present and suggests taking patient by wheelchair to safer and more private area for evaluation in SR Room. Patient able to stand and transfer to wheelchair, which we did slowly and carefully. 1034 ? Now in safer and more private area SR room with NP and RN and Dr. Firemen are here and assessing the scene with medic assessing patient. Ambulance in route, about 5 - 10 minutes out per radio communication. Checking BP every 2 minutes. Now is 68/44. C/O nausea and vomited. Pulse ox won?t pick up. Patient with decreasing LOC, eyes rolling back in head, unable to maintain posture seated, and not able to describe symptoms to us (unknown if she felt itchy but no obvious cutaneous manifestations). Unable to visualize oropharynx. 1037- BP 57/40. NP administered Epi pen 0.3 mg dose to L lateral thigh due to s/s of systemic allergic reaction/anaphylaxis including 3 known body systems: hypotension (cardiovascular), vomiting (GI), and decreased LOC (neuro). No IV fluids immediately available but were preparing to obtain. Staff getting cot for patient to lie down. Provider spoke with her mom on the phone and informed her of event. Mom confirmed that she has often before passed out with vaccines and blood draws. Dad was on his way to center and rerouted to ER. 1038 - BP 68/45 Talking to medics and able to tell them she ate breakfast and that she has a hx of Crohn's and takes a monthly injection. Informed provider that her dad was on his way. EMS team here to transport to ER. We were preparing to put her on a cot so help with her blood pressure/blood flow when she started to stabilize and EMS arrived with stretcher. 1040 - BP 97/53. Patient is now alert and talking to us. Says she has had syncope in the past ?but never anything like this.? 1041 - BP 115/53. Patient still alert and talking. Oriented x 3. 1042 - Transported to ER by EMS ambulance on stretcher. DEBRIEF: Somewhat atypical (no obvious cutaneous manifestations) and rapid, severe reaction. Ddx vasovagal vs anaphylaxis. Response to epi consistent with anaphylaxis reversal. Perhaps immunosuppressant medication contributed to severity and rapidity of reaction.
30 2021-03-21 excessive bleeding Notes (Nurse Practitioner) ? ? Family Medicine Cosigned by: MD at 3/19/2021 9:22 AM Expand AllColla... Read more
Notes (Nurse Practitioner) ? ? Family Medicine Cosigned by: MD at 3/19/2021 9:22 AM Expand AllCollapse All Clinic 3/18/2021 Patient: Date: 3/18/2021 Subjective Patient is a 30 y.o. female who was seen at COVID Vaccine Clinic today for her second dose of the COVID 19 vaccination. She was given the Pfizer vaccination in the right deltoid muscle. During her 15 minute waiting period after the injection, the patient began to experience paresthesia down R arm. She denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, lightheadedness, dizziness, facial swelling, lip swelling, tongue swelling and weakness in arm. This provider was notified of patient reaction and she was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to rapid progression of symptoms. PMH insignificant ALLERGY REVIEW OF SYSTEMS: Patient denies chills, fever, malaise/fatigue, facial swelling, sore throat, frequent throat clearing, eyes watering, eyes itching, cough, chest tightness, shortness of breath, wheezing, rash, hives, itching of skin, vomiting, abdominal pain, muscle aches, joint pain, dizziness and headaches + paresthesia in R arm: Previous Reactions: none Objective Vitals Vitals: 03/18/21 1430 BP: 108/62 Pulse: 72 SpO2: 100% Physical Exam Constitutional: General: She is not in acute distress. Appearance: Normal appearance. She is well-developed. She is not diaphoretic. HENT: Mouth/Throat: Mouth: Mucous membranes are moist. Pharynx: Oropharynx is clear. Eyes: Extraocular Movements: Extraocular movements intact. Conjunctiva/sclera: Conjunctivae normal. Pupils: Pupils are equal, round, and reactive to light. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Pulses: Normal pulses. Heart sounds: Normal heart sounds. Pulmonary: Effort: Pulmonary effort is normal. No respiratory distress. Breath sounds: Normal breath sounds. No wheezing. Skin: General: Skin is warm and dry. Neurological: General: No focal deficit present. Mental Status: She is alert and oriented to person, place, and time. Cranial Nerves: No facial asymmetry. Sensory: Sensation is intact. Motor: No weakness. Coordination: Coordination is intact. Gait: Gait normal. Comments: + 5/5 strength against resistance to bilateral upper extremities. Pt able to put on her own sweater without difficulty or assistance. Psychiatric: Mood and Affect: Mood normal. Behavior: Behavior normal. Thought Content: Thought content normal. Judgment: Judgment normal. Assessment/Plan Treatment included: ice pack Follow up response to treatment: fair. Patient discharge: Stable to go home and follow up with PCP. Differential Diagnosis: Local reaction (arm pain, bleeding/bruising, mechanical irritation, localized rash) Suspect superficial nerve secondary to injection. Discussed ice/warm cloth, movement of R arm. Follow up with pcp as needed. We will check in with her tomorrow via phone. Pt voiced appreciation of evaluation today. Nurse Practitioner Electronically Signed 3/18/2021 8:58 AM
30 2021-03-23 anaphylactic reaction Anaphylaxis, hives
30 2021-03-24 vaginal haemorrhage Vaginal bleeding/irregular bleeding; bloody noses; spotting; This is a spontaneous report from a con... Read more
Vaginal bleeding/irregular bleeding; bloody noses; spotting; This is a spontaneous report from a contactable Nurse (patient). This 30-years-old female patient received at hospital bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 administered in Arm Left on 17Feb2021 (Batch/Lot Number: EM9809) as SINGLE DOSE, and dose 2 on 07Mar2021 (Batch/Lot Number: EN6206) administered in Arm Left as SINGLE DOSE for covid-19 immunisation. Age at vaccination 30 years. Medical history included ongoing spotting (she has had her tubes tied in the past /She continued to have spotting even after the period was over). The patient got 1st dose on 17Feb2021 and developed Vaginal bleeding, bloody noses. She said she was having a period every 2 weeks, and "spotting" every other day. The she got 2nd dose on 07Mar2021, and experienced nose is bleeding and vaginal bleeding again.Then it was added she completed both; and keeps having irregular bleeding. she received the first dose of the Pfizer COVID 19 vaccination 17Feb2021 at an unknown time in the left arm. On that day she noticed irregular bleeding, spotting. Mentioned she has had her tubes tied in the past and so she called her gynecologist who made an appointment for her. Then she got her regular period two weeks later to she cancelled that appointment. She continued to have spotting even after the period was over. She mentioned this to her gynecologist twice and he said to wait and see. She received the second dose 07Mar2021 at 16:50 PM in the left arm. She noticed today on 10Mar2021 she was having vaginal bleeding and spotting with bright red blood and also a nose bleed. Mentioned she also noticed blood with sex. She was concerned and plans to contact her HCP next because her brother had osteosarcoma at 16 years old and she has a cousin who had thrombocytopenia. Seriousness criteria provided -Other medically important conditions. The outcome of the events was not recovered.; Sender's Comments: Based on available information and known drug profile it is unlikely that the reported "vaginal bleeding, spotting with bright red blood and nose bleed" were due to bnt162b2. These are probably intercurrent medical conditions. Case will be reassessed of additional information is received. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
30 2021-03-25 anaphylactic reaction 30 yo female with PMHx severe anaphylactic food allergies (peanuts, beans, shellfish), who presented... Read more
30 yo female with PMHx severe anaphylactic food allergies (peanuts, beans, shellfish), who presented for her firstdose of Pfizer COVID vaccine today. She was otherwise in her USH, received her vaccine at 2:45 PM. About 15 minutes later, began having chest pressure and SOB. Chest pressure, substernal, 8/10, w/o radiation, nonpleuritic, nonpositional, not exertional. +SOB "like I'm trying to catch my breath". No wheezing, tachypnea, tongue/throat itching/closing, runny nose, N/V, abd pain, diarrhea, hives. No LH, palp, diaphoresis. Prev h/o food allergies with severe hives, SOB, troat closing. Usually takes Benadryl with resolution. No h/o epipen use. Does not have her own epipen. Had lunch at 1 PM, does not think it she was exposed to any known allergens. On initial evauation: VS: T 98.6F, BP 140s/90s, HR 120s, RR, SaO2 99% RA. Gen: WDWN, NAD. HEENT: NCAT, sclera anicteric and w/o injection, MMM OP clear. Neck: supple, good ROM. CV: tachy, reg rhythm, S1, S2. No m/r/g. Pulm: CTAB. No wheezes or crackles. No stridor. Abd: S, NT, ND. NABS. No rebound or guarding. Extr: no c/c/e. Skin: no rashes Neuro: A&Ox3. No focal deficits. Pt given Benadryl 50 mg po x1 with improvement in chest pressure in about 20 minutes, but no change in SOB. No further sxs. Repeat VS: 133/91, HR 93, R 20, SaO2 99%, RA 125/85, HR 80sR 20, SaO2 97% RA. As sxs persisted, EMS activated.
30 2021-03-28 excessive bleeding, vaginal haemorrhage ~2 weeks pregnant during time of vaccination,
30 2021-04-06 cardiac arrest Vomiting, dizziness, diarrhea, blood sugars high. Went into cardiac arrest January 23, 2021
30 2021-04-11 anaphylactic reaction Mild anaphylaxis
30 2021-04-12 anaphylactic reaction I had a reaction until the third day that I got the vaccine, allergy (anaphylaxis).
30 2021-04-14 grand mal seizure Soon after receiving shot, PT experienced dizziness and felt like she was going to pass out, medical... Read more
Soon after receiving shot, PT experienced dizziness and felt like she was going to pass out, medical team arrived to assess. PT was conscious but shortly thereafter, she had a tonic-clonic seizure. This lasted about 2 minutes, then she was post-ictal for about a minute. Then PT was able to answer questions appropriately and knew where she was. V/S were normal including a BP of 105/70, SPO2-100%, HR-70. EMS was called to transport to ER. Over the next several minutes, PT felt dizzy and tingly. She remained stiff in extremities and had a hard time verbalizing, trying to say that her tongue felt stiff. When EMS arrived, they took her blood sugar, which was 120. She was then taken to ER for further evaluation.
30 2021-04-17 pneumonia started having pain in the right side of my chest when I inhaled/ pneumonia developing in my right l... Read more
started having pain in the right side of my chest when I inhaled/ pneumonia developing in my right lung; This is a spontaneous report received from a contactable consumer, the patient. This 30-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 30Mar2021 at 14:15 (at the age of 30-years-old) as a single dose for COVID-19 immunization. Medical history was not reported. The patient did not have allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication received within 2 weeks of vaccination included birth control. On 30Mar2021, several hours later at 21:00, when she was laying down for bed, the patient started having pain in the right side of her chest when she inhaled. It got worse while laying down. It still hurt to inhale in the morning so she went to urgent care. They did an X-ray of her lungs and determined she had pneumonia developing in her right lung. The patient stated that she had not been sick prior and no fever or anything so was not sure why it came on so suddenly. The patient was treated for pneumonia with an antibiotic. The clinical outcome of pneumonia was unknown. Since the vaccination, the patient has not been tested for COVID-19. The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow-up.
30 2021-04-18 blood clot I had my first dose of Covid 19 Pfizer vaccine on the 5th of April, 2021 at 1pm. I had sore arm and ... Read more
I had my first dose of Covid 19 Pfizer vaccine on the 5th of April, 2021 at 1pm. I had sore arm and was fatigued which was expected. However, the day I had my vaccine was also the day my menstrual cycle started and just to assure myself I informed the pharmacist and asked if that was okay and they said it shouldn?t be a concern. I was doing fine until toward the end of day 3. I was expecting my period to stop as it always does on 3rd day but I started bleeding heavier that day there after. It didn?t worry me much until I started discharging huge blood clots as big as an apple 2 times every after 30 mins from that moment. I rushed to the ER later that night(still bleeding heavily with blood clots every now and then) but I was not admitted since my vitals and the blood counts were normal at that moment. I went back home and hoped the bleeding would stop but again with on pain or fever what so ever I kept bleeding all day. This is my 5th day of bleeding. Then on Sunday morning, I still kept bleeding heavy and I was too weak that I went back to the ER again. This time , (day 6) I got admitted because I have had lost a lot of blood and I needed blood transfusion. My HB dropped from 11.3 to 6.7 and it went further down to 5 something. I got 3 units of blood transfusion in the ER. They did ultrasound, CT scans(with and without contrast) and still couldn?t figure out the cause of the bleeding. My uterus showed no problems but my body was not even responding to Tranexamic acid to stop the bleeding. So the doctor proceeded with an angiogram and did an emergency uterine artery Embolization to stop the blood supply to the uterus. The bleeding stopped there after and I started regaining my vitals. However, the cause of the bleeding still remains unknown.
30 2021-04-24 pulmonary embolism Vasovagal syncope and acute pulmonary embolism
30 2021-04-25 anaphylactic reaction patient evidently went into anaphylaxis on the drive home (companion was driving, not patient); pat... Read more
patient evidently went into anaphylaxis on the drive home (companion was driving, not patient); patient and companion had both received the vaccine and waited the requisite 15 minutes before leaving the area (reaction was delayed). When patient realized reaction had begun, companion drove her straight to the hospital to receive treatment. She self-administered epi-pen on the way; was given Benadryl, Pepcid, and a steroid at the hospital. She has recovered.
30 2021-04-30 pneumonia pneumonia; kidney infection; severely dehydrated; extreme joint pain; fever; chills; uncontrollable ... Read more
pneumonia; kidney infection; severely dehydrated; extreme joint pain; fever; chills; uncontrollable shaking; Severe headache; nausea; vomiting; When Coughing, feel pain in uterus; When Coughing, feel pain in uterus; Very sick; weak; This is a spontaneous report from a contactable consumer, the patient. This 30-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ep7533), via an unspecified route of administration in the left arm on 03Apr2021 10:00 (at the age of 30-year-old) as single dose for COVID-19 immunization. There is no medical history reported. Concomitant medication included celecoxib (CELEXA). The patient did not have any allergies to medications, food, or other products. The patient previously took the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: E46955), via an unspecified route of administration in the left arm on 11Mar2021 10:00 (at the age of 30-year-old) as single dose for COVID-19 immunization. Prior to the vaccination, the patient was not diagnosed with COVID-19. Two hours after the vaccination on 03Apr2021 at 12:00, the patient experienced extreme joint pain, fever, chills, uncontrollable shaking; severe headache, nausea and vomiting. No change after 3 days, she went to Emergency Room ended up with pneumonia, a kidney infection and severely dehydrated. She was hospitalized for one day (in Apr2021). When coughing, she feels pain in her uterus. She was very sick for 11 days after the vaccination and was still weak, and her joints continue to hurt. Therapeutic measures were taken included fluids, antibiotics, blood tests and nausea medications. Since the vaccination, the patient had been tested negative for COVID-19 virus via a nasal swab test on 06Apr2021. The patient had recovered with lasting effects from the extreme joint pain, fever, chills, uncontrollable shaking, severe headache, nausea, vomiting, pneumonia, a kidney infection, severely dehydrated, when coughing, feels pain in uterus, and very sick.
30 2021-05-02 vaginal haemorrhage 12 weeks pregnant at time of shot. Due Nov 11 2021. Second pregnancy. First pregnancy had no abonorm... Read more
12 weeks pregnant at time of shot. Due Nov 11 2021. Second pregnancy. First pregnancy had no abonormal instances. Vaginal bleeding started at about 5pm. Lower abdominal pains + constipation before bleeding. Went to ER that evening and got RhoGAM. 300 mcg. Intramuscular.
30 2021-05-02 vaginal haemorrhage Patient received the first dose 3/26/21 and believes she conceived 3/10/21. She began spotting on 4/... Read more
Patient received the first dose 3/26/21 and believes she conceived 3/10/21. She began spotting on 4/5/21 and the bleeding continued getting heavier until 4/19/21. The OB confirmed miscarriage on 4/28/21.
30 2021-05-07 blood clot period is extremely heavier than it's ever been, I have large blood clots; period is extremely heavi... Read more
period is extremely heavier than it's ever been, I have large blood clots; period is extremely heavier than it's ever been, I have large blood clots; cramping; irritability; premenstrual symptoms like cramping and irritability were the worst they've ever been; This is a spontaneous report from a contactable consumer, reporting for herself. A 30-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration, administered in the right arm on 15Apr2021 (Batch/Lot Number: Er8729) as a single dose (at the age of 30 years old) for covid-19 immunization. The patient medical history was not reported. Concomitant medication(s) included ethinylestradiol, levonorgestrel (SEASONIQUE) taken for an unspecified indication, start and stop date were not reported; spironolactone taken for an unspecified indication, start and stop date were not reported; magnesium taken for an unspecified indication, start and stop date were not reported; polycarbophil calcium (FIBER) taken for an unspecified indication, start and stop date were not reported, and an unspecified multivitamin taken for an unspecified indication, start and stop date were not reported. Historical vaccine information included BNT162B2, dose 1 via an unspecified route of administration, administered in the right arm on 25Mar2021 at 12pm (Batch/Lot Number: Er8730) as a single dose (at the age of 29 years old) for covid-19 immunization. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient experienced period is extremely heavier than it's ever been, she has large blood clots on 21Apr2021 at 08:00 with outcome of not recovered, cramping on 21Apr2021 at 08:00 with outcome of not recovered, irritability on 21Apr2021 at 08:00 with outcome of not recovered, and premenstrual symptoms like cramping and irritability were the worst they've ever been on 21Apr2021 at 08:00 with outcome of not recovered. The patient underwent lab tests and procedures which included sars-cov-2 test (nasal swab): negative on 31Mar2021. Treatment was not received for the events.
30 2021-05-09 vaginal haemorrhage I regularly have my period every 28 days for the last 16 years. My most recent period prior to the v... Read more
I regularly have my period every 28 days for the last 16 years. My most recent period prior to the vaccine started April 23, 2021 - April 27, 2021. An hour after receiving the 1st dose of the Pfizer vaccine I started spotting. It now has been 10 days and I am still spotting, some days are heavier than others. I am experiencing cramps like my normal period and breast tenderness.
30 2021-05-10 anaphylactic reaction Allergic reaction- characterized by hives and flushing and anaphylactic reaction (throat and mouth s... Read more
Allergic reaction- characterized by hives and flushing and anaphylactic reaction (throat and mouth swelling); Allergic reaction- characterized by hives and flushing and anaphylactic reaction (throat and mouth swelling); Allergic reaction- characterized by hives and flushing and anaphylactic reaction (throat and mouth swelling); Allergic reaction- characterized by hives and flushing and anaphylactic reaction (throat and mouth swelling); Allergic reaction- characterized by hives and flushing and anaphylactic reaction (throat and mouth swelling); Allergic reaction- characterized by hives and flushing and anaphylactic reaction (throat and mouth swelling); This is the spontaneous report received from a contactable other health professional. This other HCP (patient) reported for herself that a 30-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8727) at the age of 30-years, via an unspecified route of administration in left arm on 19Mar2021 13:00 at single dose for COVID-19 immunization, in hospital. Medical history included PTSD, anorexia, chronic migraines, bradycardia. Patient was not pregnancy at time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included propranolol, atorvastatin (LIPITOR), prazosin, alprazolam (XANAX). On 19Mar2021 13:15, the patient experienced allergic reaction-characterized by hives and flushing and anaphylactic reaction (throat and mouth swelling). After medical treatment, hives continued for 3-4 days. The events result in doctor or other healthcare professional office/clinic visit. The patient received high dose diphenhydramine hydrochloride (BENADRYL) and epinephrine (EPIPEN). Outcome of the events was recovered in 2021. Since the vaccination, the patient has not been tested for COVID-19.; Sender's Comments: Based on the information available and a close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of Allergic reaction, Anaphylactic reaction. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
30 2021-05-14 pulmonary embolism Developed multiple pulmonary embolisms in both lungs and left lung infarction. Resulted in hospitali... Read more
Developed multiple pulmonary embolisms in both lungs and left lung infarction. Resulted in hospitalization for 4 days and treatment in hospital and blood thinners for post discharge
30 2021-05-16 blood clot About ten days after the vaccine I started to have intense cramping and I lost a blood clot. My bell... Read more
About ten days after the vaccine I started to have intense cramping and I lost a blood clot. My belly was tightening up and I started to feel downward pressure. I also had back pain. I was checked out at the hospital, and they did not find anything wrong. I was 23 weeks pregnant at the time. I have not had any more cramping. I am also breast feeding my toddler and she was cranky and out of sorts after each dose of the vaccine. She was really irritable and she was running a low grade fever. My daughter is 22 months old. Pregnancy-second
30 2021-05-19 pulmonary embolism multiple pulmonary embolisms in both lungs; Lung infarction occurred in left lung; This is a spontan... Read more
multiple pulmonary embolisms in both lungs; Lung infarction occurred in left lung; This is a spontaneous report from a contactable consumer (patient). A 30-year-old female patient received the 2nd dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration in arm left, on 27Apr2021 at 08:00 AM at 30 years (Lot# EW0169) as single dose, for COVID-19 immunisation. The patient was not pregnant and was not pregnant at time of vaccination. Medical history was none. Patient had no known allergies. It was unknown if patient experienced COVID-19 prior to vaccination. Concomitant medication in two weeks included multivitamin. The patient did not receive any other vaccine in four weeks. Previously the patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech) for COVID-19 immunisation on 06Apr2021 at 01:30 PM in left arm (Lot# ER8734) at 30 years. The patient experienced multiple pulmonary embolisms in both lungs (caused hospitalization, life threatening) on 04May2021 at 03:00 PM with outcome of recovering, lung infarction occurred in left lung (caused hospitalization, life threatening) on 04May2021 at 03:00 PM with outcome of recovering. The patient was hospitalized from 05May2021 to 08May2021. The events also required emergency room visit. Patient was tested for COVID-19 post vaccination (nasal swab): negative on 05May2021. Therapeutic measures were taken as a result of the events and included treatment with Lovenox injections, pain management, oral blood thinner.
30 2021-05-21 cerebrovascular accident Started feeling terrible the day after the vaccine. Very tired, not feeling well, off balance. Sympt... Read more
Started feeling terrible the day after the vaccine. Very tired, not feeling well, off balance. Symptoms got so back she had to go to the ER. She ended up being transferred to another hospital because they couldn?t treat her. She has a blood clot in the carotid artery and acute strokes and brain tissue damage and numbness and loss of strength to right arm and hand
30 2021-05-25 pulmonary embolism, low platelet count Adverse event: Acute pulmonary embolism, Demand Ischemia, Prolonged Ptt, Thrombocytopenia. Treatment... Read more
Adverse event: Acute pulmonary embolism, Demand Ischemia, Prolonged Ptt, Thrombocytopenia. Treatment: Eliquis 6 months with follow up with hematology, pulmonolist, and cardiologist
30 2021-05-26 heart attack "It felt like I was having a heart attack"; severe stomach/diaphragm pain; evere stomach/diaphragm p... Read more
"It felt like I was having a heart attack"; severe stomach/diaphragm pain; evere stomach/diaphragm pain; spasms; Felt like gas and came on right after she ate bread and butter. She felt like it was in her back and chest "100 times worse than what I'm used to."; she is "unwell in general" and it is around her chest/upper stomach; She thought it was chest pain or gas; fever; Chills; Headache; body ache; soreness at injection site; This is a spontaneous report from a contactable consumer (patient). A 30-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 10May2021 at the age of 30-years-old (Lot Number: EW0173) as single dose for COVID-19 immunisation. Patient received the first dose on 19Apr2021 at the age of 30-years-old, Lot: EW0161, administered in left arm. Concomitant medications included ongoing vitamins NOS (DAILY MULTIVITAMIN); ongoing drospirenone, ethinylestradiol (LORYNA). The patient received the second dose of the Pfizer Covid 19 vaccine 10May2021. She had a fever 102.6 or 102.8 degrees Fahrenheit. It went up to 103 degrees and was now down to 101 degrees. She had chills, headache, body ache and soreness at the injection site. These symptoms started around 9:00 or 9:30pm last night. Fever, chills, headache, body ache and soreness at the injection site were with onset date 10May2021. She was hit with the whole nine yards of symptoms. She ate bread and toast earlier 11May2021 and has been having severe stomach/diaphragm pain, spasms and contractions. She thought it was chest pain or gas. She was unsure if she should be worried or if this is a side effect. This pain started around noon 11May2021. An AE was being filed however she ate bread/toast early this morning and she began having stomach/diaphragm area pain, like spasms and contractions. Patient stated symptoms have resolved for the moment and the last "attack" she had was while she was calling Pfizer. She said it came and went. Felt like gas and came on right after she ate bread and butter. She felt like it was in her back and chest "100 times worse than what I'm used to." She said she was "unwell in general" and it was around her chest/upper stomach. "It felt like I was having a heart attack". "Is this a side effect of the vaccine? Should I seek medical attention if it gets worse?" The outcome of events (severe stomach/diaphragm pain, spasms, contractions, fever, chills, headache, body ache and soreness at the injection site) was not recovered, outcome of other events was unknown.
30 2021-05-26 blood clot Menstrual cycle started again a week after my normal cycle ended. Abnormal menstrual cycle is still ... Read more
Menstrual cycle started again a week after my normal cycle ended. Abnormal menstrual cycle is still on going (started 18May2021) today is 27May2021, no sign of stopping any time soon. This abnormal menstrual cycle is extremely heavy where it is causing concern. There is a lot of blood clots.
30 2021-06-02 deep vein blood clot, blood clot 30yof, 36w pregnant, came to clinic on 6/1 with 2 week history of lower leg tenderness and edema. D... Read more
30yof, 36w pregnant, came to clinic on 6/1 with 2 week history of lower leg tenderness and edema. Doppler confirmed on 6/1 that patient had an acute proximal DVT in the left lower extremity, with occlusive thrombus within the distal femoral vein. She denies personal history of clot; this is her 2nd pregnancy; she notes no family history of clot; this pregnancy is complicated by excessive weight gain (current BMI 32.28 kg/m2). Pt received Pfizer COVID vaccine on 4/24/21.
30 2021-06-10 vaginal haemorrhage N93.9 - Abnormal uterine and vaginal bleeding, unspecified
30 2021-06-15 vaginal haemorrhage lymph node swelling in right armpit; Vaginal spotting; This is a spontaneous report from a non-conta... Read more
lymph node swelling in right armpit; Vaginal spotting; This is a spontaneous report from a non-contactable consumer (patient). A 30-year-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Right on 12Mar2021 08:30 (Batch/Lot Number: EN6206) as single dose at the age of 30-year-old for COVID-19 immunisation, administered at hospital. Medical history included seasonal allergy. Concomitant medication(s) included fexofenadine hydrochloride (ALLEGRA); fluticasone propionate (FLONASE), both taken for an unspecified indication, start and stop date were not reported. The patient was not pregnant. The patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in arm right on 19Feb2021 08:15 (Batch/Lot Number: EM9810) as single dose at the age of 30-year-old for COVID-19 immunisation. No other vaccine in four weeks. No COVID prior vaccination. The patient experienced lymph node swelling in right armpit (non-serious) on 13Mar2021 with outcome of unknown, vaginal spotting (non-serious) on 13Mar2021 with outcome of unknown. No treatment received. COVID was not tested post vaccination. No follow-up attempts are possible. No further information is expected.
30 2021-06-21 severe muscle breakdown April 19th 2021 i had taken a spin class. prior to this spin class i started walking and exercising ... Read more
April 19th 2021 i had taken a spin class. prior to this spin class i started walking and exercising regularly. After the spin class i was quite sore. a few days went by and by thursday i could barely walk. ( i had stopped all exercise after monday) Friday morning i had went to my local urgent care. The doctor there did xrays and ran blood work. By that night they had called me and told me i needed to go to the hospital and i was diagnosed with Rhabdomyolysis. The muscle pain in my legs was so bad and i was exhausted. I was discharged from the hospital the night of april the 25th. no one could figure out why this happened to me at such a young age and for only going to one spin class that i didnt even work to hard at.
30 2021-06-28 vaginal haemorrhage O20.9 - Vaginal bleeding affecting early pregnancy
30 2021-06-30 fluid around the heart chest pain/SOB; chest pain/SOB; large pericardial effusion; hemodynamic instability; started explori... Read more
chest pain/SOB; chest pain/SOB; large pericardial effusion; hemodynamic instability; started exploring Lupus; joint pain; low WBC; This is a spontaneous report from a contactable pharmacist (patient). A 31 years old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration on 07Jan2021 (Lot Number: EL1283) at the age of 30 years old, as single dose for covid-19 immunisation. Medical history included sulfa products cause rash, anxiety, migraine. Concomitant medications included sumatriptan succinate (IMITREX); ibuprofen (MOTRIN); paracetamol (TYLENOL), OTC vitamin B complex supplement, OTC iron supplement. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), on 16Dec2020 (Lot Number: EK9899) at the age of 30 years old, as single dose for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient came to the ER on 14Jun2021 for chest pain/SOB, CT scan found large pericardial effusion, had to undergo emergency pericardiocentesis due to hemodynamic instability and hospitalized from 14Jun2021 and until 17Jun2021. Labs on fluid ruled our infectious or cancer origin. The patient had no prior medical history aside from anxiety and migraines, although the patient had recently started exploring Lupus but not confirmed. The patient have biomarkers consistent with Lupus, minor and infrequent joint pain, and chronically low WBC but WBC is unaffected by plaquenil (plaquenil started after vaccine) and no trademark rash. Events started from 06Jun2021 and resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event). Treatment pericardiocentesis, prednisone, ibuprofen, colchicine, Nexium was received. The outcome of the events was Recovered with lasting effects/ Recovered with Sequel. Follow-up attempts are possible. Further information is expected.; Sender's Comments: Based on known safety profile and lack of close temporal association the reported events are assessed as intercurrent medical conditions and unrelated to BNT162B2. Case will be reassessed if additional information is received. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
30 2021-07-05 heart attack my wife died of a hart attack 4 days after her shot she was only 30 years old,. with no previous sym... Read more
my wife died of a hart attack 4 days after her shot she was only 30 years old,. with no previous symtoms. please explain to me how this could happen.
30 2021-07-05 pulmonary embolism I had a pulmonary embolism, Er treatment and have been on anticoagulation ever since
30 2021-07-07 blood clot, vaginal haemorrhage On April 12th, I took a pregnancy test and it was positive. I started feeling sick and feeling pain ... Read more
On April 12th, I took a pregnancy test and it was positive. I started feeling sick and feeling pain on April 26th. I started bleeding and had blood clots, which continued to April 28th. I went to the ER. I took an ultrasound and took lab work every 3 days. I was told that I may have been having a miscarriage or an ectopic pregnancy. On April 30th, I did lab work. On May 4th, I took a transvaginal and a regular ultrasound. On May 5th, the doctor believed I was having a ectopic pregnancy. On May 6th, I went in for surgery and they had to remove my left fallopian tube. I also had a D&C. I suffered a miscarriage.
30 2021-07-12 deep vein blood clot Left arm, chest, and leg pain approximately 7-10 days after first Pfizer shot. My hematologist sent ... Read more
Left arm, chest, and leg pain approximately 7-10 days after first Pfizer shot. My hematologist sent me into radiology to get imaging done and a new DVT was found in my left arm and also near my left clavicle. I was hospitalized for 3 days and was switched from Eliquis to Warfarin.
30 2021-07-16 anaphylactic reaction Site: Swelling at Injection Site-Mild, Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: D... Read more
Site: Swelling at Injection Site-Mild, Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Chest Tightness / Heaviness / Pain-Severe, Systemic: Dizziness / Lightheadness-Medium, Systemic: Numbness (specify: facial area, extremities)-Severe, Systemic: Tingling (specify: facial area, extemities)-Severe
30 2021-07-16 blood clot I have had clotty periods since my first dose of the vaccine and it isn?t stopping. It isn?t as heav... Read more
I have had clotty periods since my first dose of the vaccine and it isn?t stopping. It isn?t as heavy as usual but it?s a constant period that doesn?t go away even with taking birth control.
30 2021-07-21 anaphylactic reaction The day of the vaccine, anaphylaxis (difficulty breathing, accelerated heartbeat, fever, chills, con... Read more
The day of the vaccine, anaphylaxis (difficulty breathing, accelerated heartbeat, fever, chills, confusion). From then and ongoing for the last six months, severe daily heart pains and very weak immune system.
30 2021-07-27 vaginal haemorrhage Typical Fever; Headache; Body aches; spotting; had constipation; This is a spontaneous report from a... Read more
Typical Fever; Headache; Body aches; spotting; had constipation; This is a spontaneous report from a contactable pharmacist, the patient. A 30-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9264), dose 2 via an unspecified route of administration, administered in Arm Left on 26Feb2021 15:00 (at the age of 30-years-old) as a single dose for covid-19 immunization. Patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3248), dose 1 via an unspecified route of administration, administered in Arm Left on 03Feb2021 17:00 (at the age of 30-years-old) as a single dose for covid-19 immunization. Medical history included orthostatic hypotension, postural orthostatic tachycardia syndrome, pneumothorax spontaneous, irritable bowel syndrome. The patient had known allergies with hydrocodone, codeine, latex, triptans, adhesives. The patient had no other vaccine within four weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medication(s) in two weeks included propranolol, folic acid, prenatal vitamins, omeprazole. On 26Feb2021, she had constipation the day of and day after. On 28Feb2021 11:00, the patient experienced along with the typical fever, headache, and body aches on the day after, had some spotting about 36 hours post-vaccination. My menstrual cycle had ended 4 days prior, so she know it wasn't part of her cycle. It never showed up on a panty liner, it was only when she wiped. Occurred after urination twice within 5 hours. The patient did not receive any treatment. Outcome of the event was recovered, at the time of this report. No follow-up attempts are possible. No further information is expected.
30 2021-07-29 grand mal seizure Grand mal seizure took place about 10 minutes after administration. Paramedics arrived on scene afte... Read more
Grand mal seizure took place about 10 minutes after administration. Paramedics arrived on scene after seizure had ended. Upon examining the patient, EMT determined the pt was fit to go home
31 2021-01-01 pneumonia Left lower lobe Pneumonia with small pleural effusion
31 2021-01-05 anaphylactic reaction anaphylaxis
31 2021-01-05 blood clot Worsening arm pain after injection that eventually resulted in my being diagnosed with a blood clot ... Read more
Worsening arm pain after injection that eventually resulted in my being diagnosed with a blood clot in the arm that I recevied the injection on
31 2021-01-18 anaphylactic reaction Anaphylaxis less than two hours after vaccination. I had no symptoms immediately after vaccine howev... Read more
Anaphylaxis less than two hours after vaccination. I had no symptoms immediately after vaccine however did develop symptoms within one minute of completing a run. Developed b/l hand swelling and tingling, diffuse hives and itching, tachycardia, elevated blood pressure, lips tingling and swelling which required emergency room visit and EpiPen, IV fluids, Benadryl and IV steroids. This is similar to previous reactions I have had to running previously. Symptoms resolved within one hour after treatment in ED.
31 2021-01-19 deep vein blood clot Employee received her 2nd Pfizer vaccine on 1/12/2021. Twelve hours after her vaccine she develope... Read more
Employee received her 2nd Pfizer vaccine on 1/12/2021. Twelve hours after her vaccine she developed a fever with a T-max of 102 degrees. The fever lasted 18 hours. She also complained of severe malaise and fatigue lasting 36 hours. On day 3 (Friday, January 15, 2021) she developed left lower extremity pain that persisted over the weekend. She was seen in Urgent Care today where she was diagnosed with a deep vein thrombosis of the proximal vein. She also came to the ETC and was ruled out for a PE. The employee does have a family history of antiphospholipid in her mother. She has a follow up with her PCP and will also receive a work up in hematology as she had never been tested for any genetic coagulation conditions after her mom's diagnosis.
31 2021-01-19 blood clot Employee received her 2nd Pfizer vaccine on 1/12/2021. Twelve hours later she developed a fever wit... Read more
Employee received her 2nd Pfizer vaccine on 1/12/2021. Twelve hours later she developed a fever with a T-max of 102 degrees. The fever lasted 18 hours. She also complained of severe malaise and fatigue lasting 36 hours. On day 3 she developed left lower extremity pain that persisted over the weekend. She was seen in Urgent Care today where she was diagnosed with a thrombosis. She also came to the ETC and was ruled out for a PE The employee does have a family history of antiphospholipid in her mother. She has a follow up with her PCP and will also receive a work up in hematology as she had never been tested for any genetic coagulation conditions after her mom's diagnosis.
31 2021-01-25 pulmonary embolism Pulmonary embolism.
31 2021-01-28 anaphylactic shock Went into anaphylactic shock. Started feeling dizzy and light headed 15 mins after the vaccine was ... Read more
Went into anaphylactic shock. Started feeling dizzy and light headed 15 mins after the vaccine was given. At 20 mins my throat felt tighter and it was making me cough trying to get air so they gave me 50 ml of benedryl into my right arm. I started to pass out and my breathing was labored so I was given my epipen and taken to the ER. While I was there I was monitored for 4 hours and given 2 more medications. One was a steroid, I?m unsure on the second.
31 2021-02-01 low blood platelet count Immune Thrombocytopenia Purpura; the only feature that was new to her was the vaccination provided 2... Read more
Immune Thrombocytopenia Purpura; the only feature that was new to her was the vaccination provided 23Dec2020 and 09Jan2021 to complete her COVID series; This is a spontaneous report from a contactable physician. A 31-year-old female patient (not pregnant) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 09Jan2021 at single dose for covid-19 immunization. Medical history included eczema, no known allergies. There were no concomitant medications. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via Intramuscular on 23Dec2020 at single dose for covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was seen in the ED for petechiae and ecchymoses on 15Jan2021. She had not taken any recent medication or had any illness previous to this event. The only feature that was new to her was the vaccination provided 23Dec2020 and 09Jan2021 to complete her COVID series. Lab assessment showed platelet count decreased to 22,000 cells per cubic microliter (normal over 140,000). She had no other findings to describe cause of her decreased platelet count by lab or clinical exam. Provided a diagnosis of immune thrombocytopenia purpura, in the ED setting, she started pulse dexamethasone 40 mg/day for four consecutive days with a follow blood count showing resolution on day 4 of her treatment with a platelet count of 230,000 cells per cubic microliter. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient received Steroids as treatment. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of event immune thrombocytopenia purpura was recovered in Jan2021. Information on lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported event of immune thrombocytopenia purpura due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including platelet count at baseline and during therapy with subject drug, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
31 2021-02-03 vaginal haemorrhage experienced vaginal spotting started at approximately 12:10 PM and continued until 11PM. Approximate... Read more
experienced vaginal spotting started at approximately 12:10 PM and continued until 11PM. Approximately 5 weeks pregnant at time of injection, estimated due date 10/07/2021.
31 2021-02-09 anaphylactic reaction Still getting heat rashes; Had an anaphylactic reaction; Feels tired all day; This is a spontaneous ... Read more
Still getting heat rashes; Had an anaphylactic reaction; Feels tired all day; This is a spontaneous report from a contactable consumer (patient). A 31-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3302), via an unspecified route of administration in arm left on 22Jan2021 09:30 at single dose for COVID-19 immunisation. Medical history included Hashimoto's disease. The patient's concomitant medications were not reported. The patient previously took HPV VACCINE VLP RL1 4V (YEAST) (GARDASIL, number of previous doses: 3), and clindamycin and experienced allergic to clindamycin. The patient experienced an anaphylactic reaction on 22Jan2021 09:45 requiring treatment with an Epipen and transportation to the hospital, heat rashes up until last night 24Jan2021, and felt tired all day in Jan2021. Patient was "worried about how much benadryl" she had been taking. Patient went to the emergency room (ER), received some treatment and was released after 5 hours. She was not fully recovered. She was still experiencing rashes and felt tired all day. Treatment received for events anaphylactic reaction and heat rashes. The patient underwent lab tests and procedures which included blood work: normal on 22Jan2021, and white cell count: slightly increased on 22Jan2021. Outcome of event anaphylactic reaction was resolving, and of other events was not resolved.
31 2021-02-10 low platelet count Received the 2nd dose of Pfizer/BioNTech COVID vaccine on 1/12/21. Then, 2 days later (1/14/21) I ha... Read more
Received the 2nd dose of Pfizer/BioNTech COVID vaccine on 1/12/21. Then, 2 days later (1/14/21) I had a CBC with diff drawn, as I am currently being worked up for possible ITP and have been getting a CBC with diff every 2 months to monitor my blood counts. My platelets and other blood counts had been trending up and were back in normal ranges when they were last checked back in November. However, when they were checked again in January after the COVID vaccine series, there was evidence of thrombocytopenia and leukopenia. I did not have any symptoms related to decreased blood counts.
31 2021-02-25 anaphylactic reaction Light cough; Shortness of breath; Anaphylaxis; lost voice entirely; This is a spontaneous report fro... Read more
Light cough; Shortness of breath; Anaphylaxis; lost voice entirely; This is a spontaneous report from a contactable consumer (patient). A 31-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration, on 11Feb2021 at 13:15, at single dose, for COVID-19 immunisation. Medical history was none. Patient did not have known allergies and did not have COVID-19 prior to vaccination. Concomitant medications included piroxicam (PAXIL) and lisdexamfetamine mesilate (VYVANSE). Patient did not receive other vaccines in four weeks. The patient experienced light cough on 11Feb2021 at 14:45 with outcome of recovering, shortness of breath on 11Feb2021 with outcome of recovering, anaphylaxis on 11Feb2021 with outcome of recovering, lost voice entirely on 11Feb2021 with outcome of recovering. The events required emergency room visit and physician office visit. The patient was hospitalized due to the events in Feb2021 for 1 day. Events were considered life threatening. Clinical course: light cough after half an hour from vaccination. Within 2 to 3 hours had lost voice entirely and was suffering from shortness of breath. Her primary physician told her to go to the emergency room or he was calling an ambulance because he said it sounded like anaphylaxis and that her life was in danger. Therapeutic measures were taken as a result of the events and included treatment with intravenous (IV) Decadron Pepcid and epinephrine. She received the 2nd dose on 21Feb2021 at 01:15 PM. Patient was not tested for COVID-19 post vaccination. The information on the lot/batch number has been requested.
31 2021-03-01 anaphylactic reaction Adverse reaction after receiving the COVID-19 vaccine in Vaccine Clinic. Medications: No current o... Read more
Adverse reaction after receiving the COVID-19 vaccine in Vaccine Clinic. Medications: No current outpatient medications on file. Allergies: Not on File Medical history: No past medical history on file. This was vaccine dose 2 of the Pfizer COVID-19 vaccine. Describe adverse reaction: Dizziness. Employee was monitored for 40 minutes. Anaphylaxis symptoms: Dizziness Anaphylaxis plan: Provided water, juice and crackers, monitoring on gurney Vasovagal symptoms: dizziness Vasovagal plan: offer water Administration error: n/a MERT called No Transferred to Home VAERS report number: Report online Email sent to Clinic and patient documented in adverse reaction log.
31 2021-03-05 pulmonary embolism Blood clot in lung
31 2021-03-10 anaphylactic reaction ANAPHYLACTIC REACTION- TROUBLE BREATHING
31 2021-03-10 vaginal haemorrhage My menstrual period had terminated on the previous Saturday. On the day of the vaccine (Tuesday) 3/4... Read more
My menstrual period had terminated on the previous Saturday. On the day of the vaccine (Tuesday) 3/4 hours after the vaccine I started spotting. This then transformed into moderate vaginal bleeding which lasted for about 4 days. I had no other symptoms and this was very unusual and scary. I had a vaginal ultrasound 2 days after the bleeding started and no abnornalities were found. My pap smear is also clear.
31 2021-03-13 excessive bleeding Patient started having pain prior to her injection on 3/11/21. On 3/12/21, she started bleeding, an... Read more
Patient started having pain prior to her injection on 3/11/21. On 3/12/21, she started bleeding, and on 3/14/21 she miscarried at 13 weeks.
31 2021-03-14 anaphylactic shock Heaviness on chest (still on going--breathless after speaking/difficulty breathing); began 4 days af... Read more
Heaviness on chest (still on going--breathless after speaking/difficulty breathing); began 4 days after vaccine was given. 1st it was just fatigue and breathlessness, then I got a tingling feeling on left side of chest and tightness. After ER visit I was advised to take Zyrtec and Benadryl. I've paired it with Mucinex to get rid of phlegm build-up and the doctor prescribed Prednisone which I'm going to start today (03/15/2021). So far I have less tightness/less tingling in heart area (still occurs randomly but not as opten) but still get fatigued and breathless real quick. I've also had sporadic headaches brain fog, body chills/aches/weakness/difficulty concentrating. Also had face numbness for 4 days.
31 2021-03-17 excessive bleeding a couple weeks after the vaccine I started bleeding Jan 3rd around 6pm that night, I relaxed at home... Read more
a couple weeks after the vaccine I started bleeding Jan 3rd around 6pm that night, I relaxed at home later in the night I started having contractions at 4am I called my OB, I had an appointment the next morning and when I went in I was dilated 4cm so I went to deliver him that day. Everything was normal and baby was healthy. I was 36 weeks, original due date 3/4/2021, birth weight: 6lbs 2 z
31 2021-03-28 vaginal haemorrhage Miscarriage; spotting; This is a spontaneous report from a contactable nurse (patient). A 31-year-ol... Read more
Miscarriage; spotting; This is a spontaneous report from a contactable nurse (patient). A 31-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249), intramuscular at right deltoid on 04Feb2021 at single dose for COVID-19 immunization. Medical history was reported as none. She has no known allergies and has no COVID prior to vaccination. Concomitant medications included folic acid, iron (PRENATAL) and fluoxetine. The patient has no other vaccine in four weeks. The patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Ek9231) at the age of 31-years-old, intramuscular at right arm on 14Jan2021 at 12:30 at single dose for COVID-19 immunization. The vaccine was administered in a hospital. The patient was pregnant, her last menstrual period was on 19Dec2020. Her expected due date is on 25Sep2021 and gestational period was 7 weeks (also reported as 3). The patient experienced miscarriage and spotting on 09Feb2021 which resulted in doctor or other healthcare professional office/clinic visit. She was not tested for COVID post vaccination. The outcome of the events was recovering.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of miscarriage and vaginal hemorrhage due to temporal relationship. However, the reported events may possibly represent intercurrent medical conditions in this patient. There is limited information provided in this report. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
31 2021-03-31 anaphylactic reaction Anaphylaxis; Swelling/tightness of the throat and chest; Swelling/tightness of the throat and chest;... Read more
Anaphylaxis; Swelling/tightness of the throat and chest; Swelling/tightness of the throat and chest; Swelling of the tongue; numbness of the tongue; persistent disorientation; confusion; Rapid heartbeat; This is a spontaneous report from a contactable consumer (patient herself). A 31-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6207), via an unspecified route of administration in left arm on 17Mar2021 as a single dose for COVID-19 immunisation. Medical history included rheumatoid arthritis (RA) and asthma. The patient had no known medical allergens. Concomitant medications in two weeks included amoxicillin, clavulanic acid (AMOXCLAV 875-125 MG) and cetirizine hydrochloride (ZYRTEC 10 MG). The patient did not receive other vaccines in four weeks. The patient was not pregnant and was not diagnosed with COVID prior to vaccination. On 17Mar2021 12:15 PM, the patient experienced anaphylaxis, swelling/tightness of the throat and chest, swelling of the tongue, numbness of the tongue, persistent disorientation and confusion, and rapid heartbeat. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, life threatening illness (immediate risk of death from the event). Treatment included 2 Epipens, Benadryl 25 mg, and intravenous Benadryl. Outcome of the events was not recovered. The patient was not tested for COVID post vaccination.
31 2021-04-02 anaphylactic reaction Systemic: Allergic: Anaphylaxis-Mild, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Aller... Read more
Systemic: Allergic: Anaphylaxis-Mild, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Allergic: Itch Generalized-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Systemic: Abdominal Pain-Mild, Systemic: Nausea-Mild, Systemic: Tachycardia-Mild, Additional Details: patient also experienced runny nose and congestion
31 2021-04-05 anaphylactic reaction Patient had an anaphylactic reaction, feeling palpitations and feeling of throat swelling after rec... Read more
Patient had an anaphylactic reaction, feeling palpitations and feeling of throat swelling after receiving the vaccine and was taken to the Emergency Room on 2/25/21. She was given benadryl IM, Famotidine IV and Solu-Medrol injection and was discharged home with benadryl capsules and prednisone. On 3/4/21 the patient returned to the Emergency Room with side effects including chills, chest pain, palpitations, abdominal pain, nausea, vomiting and headaches. Patient was administered maalox, ketorolac IM and reglan injection.
31 2021-04-09 anaphylactic reaction Client was vaccinated next to EMT ambulance due to prior allergic reactions and medical history. App... Read more
Client was vaccinated next to EMT ambulance due to prior allergic reactions and medical history. Approximately 3 minutes after vaccination, client reported onset of throat tightening and proceeded to progress to a full anaphylactic reaction, with stridor and respiratory distress. At one minute after onset of symptoms, patient was administered 0.3 mL epinephrine IM in the left deltoid, and was transferred to a gurney and then into the rig, where oxygen was applied via non-rebreather mask at 12L/min, and vital signs were taken with a HR of 96 and BP of 146/113. Respirations were stridorous and approximately 40-60. SaO2 after oxygen was high 90's. Within the next 3-5 minutes, stridor lessened and client appeared more comfortable and gave a "thumbs up sign". IM Benadryl was given at approximately 8 minutes post onset. A second transport ambulance from Medical Center was requested at onset of symptoms and arrived shortly after the dose of Benadryl. Stridor was minimal and vital signs were HR 95, BP 123/78, with improved respirations, minimal stridor, no accessory muscle use and good air entry. SaO2 was 100% on oxygen. IV attempt was unsuccessful by local EMT and patient was transferred to the second team for further care and transport to the Medical Center.
31 2021-04-11 excessive bleeding I take medication for endometriosis that prevents me from having periods. I started cramping and ble... Read more
I take medication for endometriosis that prevents me from having periods. I started cramping and bleeding slightly earlier. So far I still am but am monitoring my symptoms
31 2021-04-15 anaphylactic reaction Site: Itching at Injection Site-Severe, Site: Redness at Injection Site-Medium, Site: Swelling at In... Read more
Site: Itching at Injection Site-Severe, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Rash Generalized-Medium, Additional Details: pcp. it was the weekend after her vaccine she got \"hives all over body and itchy\" We reccomended she take bendryl and head to the emergency room after she reported to us.
31 2021-04-23 anaphylactic reaction Vaccine was given in multiple doses aver the course of. 5 hours due to history of MCAS. Post second ... Read more
Vaccine was given in multiple doses aver the course of. 5 hours due to history of MCAS. Post second dose GI manifestations of mast cell activation. Syndrome started - abdominal and esophageal pain which were treated with Pepcid ac. 48 hours post vaccine facial flushing and hives appeared all over both arms. Extreme fatigue, shaking, gi pain, etc. Mast cell activation syndrome was well controlled pre vaccine post vaccine it is out of control with increased scores. Serious anaphylaxis first occurred two days post vaccine (10 April 21) and required two epi pens to stop. since then there have been daily mast cell attacks consisting of headaches, fatigue, gipain, hives all over arms, and legs, shaking,. Patients Xolair dose was increased and Zyrtec was increased on 22 Apr 2021) to no avail. I continue to have daily debilitating mast cell symptoms. I had serious anaphylaxis again on 23 APR 2021 - full body hives, flushing, vomiting, difficulty breathing, low blood pressure is chin required epinephrine. I fear for my life and wish I had never gotten the vaccine. This is completely debilitating.
31 2021-04-24 vaginal haemorrhage spotting vaginally; miscarriage; Following the vaccine on 18Mar; This is a spontaneous report from a... Read more
spotting vaginally; miscarriage; Following the vaccine on 18Mar; This is a spontaneous report from a contactable consumer (patient). A pregnant 31-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 18Mar2021 at 17:00 (at the age of 31 years old) (Lot Number: EN6204, unknown expiration) as a single dose for COVID-19 immunisation. Medical history included anxiety. No known allergies. Concomitant medications included escitalopram oxalate (LEXAPRO) and unspecified prenatal vitamins. The patient reported that following the vaccine on 18Mar2021 at 23:00 (11:00 pm), she began spotting vaginally which persisted for two weeks and resulted in a miscarriage at 7 weeks pregnant. The patient is pregnant on 04Jan2021. The mother was supposed to deliver on 19Nov2021. The events resulted in doctor or other healthcare professional office/clinic visit. The patient did not received treatment for the events. The patient has no COVID prior to vaccination and was not tested for COVID post vaccination. The patient did not have other vaccine in four weeks. The patient is recovering from the events. No follow-up attempts are possible. No further information is expected.
31 2021-04-27 excessive bleeding Type of Adverse Event: Abnormal bleeding/spotting Date of Adverse Event: Thursday, 4/15/2021-Thursda... Read more
Type of Adverse Event: Abnormal bleeding/spotting Date of Adverse Event: Thursday, 4/15/2021-Thursday, 4/15/2021 (within the same day); less than 1 hour; duration of event approximately 3-5 minutes Treatment: None; self-monitor bleeding/symptoms Outcome: Bleeding stopped/disappeared without any treatment or invention Other details: Patient (myself) had reported experience of a single occurrence of abnormal bleeding, minimal/very light spotting associated with in-between periods. Patient had first reported adverse event (side effect) to patient physician (OBGYN). The patient's physician (OBGYN) had advised the patient to report side effect/adverse event to the vaccination site/VAERS. Date of event had occurred exactly one week to the day of vaccination (first dose of vaccine). Abnormal bleeding/spotting in-between periods is extremely unusual and abnormal for the patient. Patient is not pregnant or breastfeeding. No patient use of medications/prescriptions/antibiotics/birth control/hormonal therapy/surgeries/injuries/drugs/alcohol.
31 2021-04-28 vaginal haemorrhage I was 7 and half weeks pregnant when I received the second covid vaccine, then a week later, I began... Read more
I was 7 and half weeks pregnant when I received the second covid vaccine, then a week later, I began to have vaginal bleeding. 5 days after bleeding began, I miscarried while at home, passing a lot of tissue and lost a lot of blood, had to go the ER, had a syncopal episode due to blood loss and had to have an emergency D & C.
31 2021-05-01 anaphylactic reaction Patient developed anaphylaxis 2 hours after receiving Pfizer shot. She had swollen lips and her thr... Read more
Patient developed anaphylaxis 2 hours after receiving Pfizer shot. She had swollen lips and her throat began to swell. She took a 25mg Benadryl 2.5 hours after the shot and is continuing to monitor to see if she needs to seek medical attention.
31 2021-05-02 grand mal seizure grand mal seizure
31 2021-05-07 vaginal haemorrhage I am 7 weeks pregnant and received my second Covid vaccine. 3 days later I started spotting and HCG ... Read more
I am 7 weeks pregnant and received my second Covid vaccine. 3 days later I started spotting and HCG levels are decreasing (threatened miscarriage)
31 2021-05-09 vaginal haemorrhage N93.9 - Abnormal uterine and vaginal bleeding, unspecified.
31 2021-05-11 blood clot Irregular, prolonged, heavy menstration with clots lasting greater than 7 days.
31 2021-05-18 vaginal haemorrhage I was 22 weeks pregnant when I received the first dose of the Pfizer vaccine. Then, 2 weeks later w... Read more
I was 22 weeks pregnant when I received the first dose of the Pfizer vaccine. Then, 2 weeks later when I was 24 weeks pregnant, I started having vaginal bleeding. I was in the hospital for 3 days as the doctors believed I may be going into very early labor. They suspect a partial placenta abruption. As a result, my cervix was found to be short, also indicating potential early labor coming. I was put on bed rest. Two weeks after the bleeding started, I lost much of my mucus plug (at 26 weeks). When at hospital at 24 weeks, I was given steroids to make my baby?s lungs develop faster just in case he?s born soon. I was also prescribed progesterone which I?ve been taking nightly. I?m now also taking magnesium supplements and drinking chamomile tea. This may be unrelated, but I have also been found to be low in iron so now I?m taking iron supplements too. Due date is Aug 2, 2021; I?m 31 years old; I am currently 29 weeks pregnant and still have not gone into labor; This is my second pregnancy, my first pregnancy was two years prior, and it was 100% healthy.
31 2021-05-22 vaginal haemorrhage Heavy vaginal bleeding
31 2021-05-25 pulmonary embolism A 31=year-old female received the first dose of mRNA Covid-19 vaccine (EW0179, Pfizer) IM on May 11t... Read more
A 31=year-old female received the first dose of mRNA Covid-19 vaccine (EW0179, Pfizer) IM on May 11th, 2021, without any reported clinical problem. Patient has no known medical illness and no previous history of DVT or PE. Patient had negative COVID-19 PCR on April 16th, 2021. She had 3 healthy pregnancies and no miscarriages. She did not have any long flights or car rides for the last several months, except for over 2 months ago. Patient denies any allergic problems, smoking tobacco or use any oral contraceptives. However, patient stated patient's father has a history of unprovoked DVT. On May 20th, 2021 patient experienced worsening of left-sided chest pain and shortness and visit ED on May 22nd, 2021. At the ED, physical examination was unremarkable. Blood tests (renal, hepatic function) were normal and labs resulted in D-dimer 0.86 mcg (FEU)/mL and platelet count 288k (Baseline of 200-250k). CT showed suspected very subtle segmental and subsegmental PE involving the left lower lobe. Duplex did not show evidence of DVT in either lower extremity. Given the family history of DVT, hypercoaguable workup was done with the following results: homocysteine level 5.5, thrombin time 14.9, negative factor II and V mutations, cardiolipin Ab IgG < 1.6 GPL (normal range < 20 GPL), lupus anticoagulant with reflex indeterminate, protein C activity 92 (normal range 70-130%) and protein S activity 67 (normal range 65-140%). Patient was admitted to the hospital. At the ED, enoxaparin 60 mg x 1 and morphine 4 mg x 1 were given. Later, it was switched to apixaban 10 mg BID on the floor and patient was discharged with apixaban 5 mg BID x 7 days and once daily BID. Patient is scheduled to follow up with her PCP in regards to the duration of therapy.
31 2021-05-26 excessive bleeding bleeding; headaches; facial pain; hot flushes; breathlessness; severe body aches; upset stomach; sku... Read more
bleeding; headaches; facial pain; hot flushes; breathlessness; severe body aches; upset stomach; skull pain; numbness in lips; blurred vision; This is a spontaneous report received from a contactable consumer (patient). A 31-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in left arm on 04May2021 17:30 (Batch/Lot Number: EW0165) (age at vaccination: 31 years old) as single dose for COVD-19 immunisation. The patient had received dose 1 of BNT162b2 on 13Apr2021 17:00 (Batch/lot number: EW0162) administered in left arm for COVID-19 immunization. The patient had no relevant history, no prior drug, no known allergies. The patient's concomitant medications were not reported. No other vaccines received within 4 weeks prior to the COVID vaccine. The patient had not had COVID prior to the vaccination, unknown if tested post the vaccination. The patient experienced severe headaches, facial pain, hot flushes, bleeding, breathlessness, severe body aches, upset stomach, skull pain, numbness in lips, blurred vision. Event onset date wsa 07May2021 at 08:00. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. It's unknown if any treatment was received for the events. The events were not resolved.
31 2021-05-27 vaginal haemorrhage Received second shot at 10 weeks pregnant (due 12/6/21). The night of 5/14 - started having night sw... Read more
Received second shot at 10 weeks pregnant (due 12/6/21). The night of 5/14 - started having night sweats, extreme lower back pain, nausea, and spotting from the vagina. All of these symptoms were new and none were experienced during pregnancy otherwise. (After the first shot at 7 weeks pregnant, only had a sore arm at injection site) On 5/15 - multiple episodes of vomiting, excessive exhaustion, and bleeding continued. 5/16-5/25 - bleeding increased Went to OBGYN 5/17 & 5/25 to get checked and both times they were able to locate a heartbeat, but were unsure why bleeding continued to occur. 5/25 11:30pm woke up in excessive pain and bleeding, resulting in a miscarriage. 5/26 2:00am ER confirmed miscarriage.
31 2021-05-31 deep vein blood clot DVT right leg, er visit, medication, still get my treatment Seizure
31 2021-06-07 cerebrovascular accident Pt developed a sudden onset of right-sided facial numbness and right arm and right leg weakness. Ca... Read more
Pt developed a sudden onset of right-sided facial numbness and right arm and right leg weakness. Came to the emergency department was found to have a stroke and given tPA with resolution of symptoms
31 2021-06-15 deep vein blood clot DVT in upper R arm.
31 2021-06-16 blood clot Beginning the month after the first injection, my menstrual cycle became extremely heavy, with a lar... Read more
Beginning the month after the first injection, my menstrual cycle became extremely heavy, with a large volume of very big clots. I have never experienced this in 20 years of having a period. My cycle went from 4 days to 7, and I have to wear an adult diaper during these days now. I have had bloodwork and an ultrasound, which showed increased thickness in uterine lining. Now having to have a biopsy done. This has continued with every cycle following my first injection.
31 2021-06-18 vaginal haemorrhage I found out I was pregnant on March 3rd, 2021 from an at-home pregnancy test. The pregnancy was con... Read more
I found out I was pregnant on March 3rd, 2021 from an at-home pregnancy test. The pregnancy was confirmed with blood work on March 6th, 2021. I received my first dose of the covid vaccine on March 8th, 2021. I noticed some light spotting afterwards. The heartbeat was confirmed on March 22nd and I was told I was six weeks along. I received my second dose on March 29th. The heartbeat was confirmed again during another ultrasound on April 20th, 2021. During an ultrasound on May 4th, 2021 I was told that there was no longer a heartbeat and the baby had stopped developing a week prior. This missed miscarriage resulted in an D&C on May 11th, 2021.
31 2021-06-20 vaginal haemorrhage I have been on my contraceptive and skipping placebos with no issues or bleeding for 2-3 years. On M... Read more
I have been on my contraceptive and skipping placebos with no issues or bleeding for 2-3 years. On May 19, I started having vaginal bleeding, very light, which continues today, day 33.
31 2021-06-27 fluid around the heart Fluid around heart, symptoms of myocarditis, ventricle wall thickening, large trivial pericardial fu... Read more
Fluid around heart, symptoms of myocarditis, ventricle wall thickening, large trivial pericardial fusion, mitrial valve has trivial regurgitation, tricuspid valve moderate regurgitation, aortic valve leaflet is leaking, runs of svt's and pvc's
31 2021-07-03 anaphylactic reaction Urticaria (on back of neck, bilateral arms), upper lip swelling and scratchy sensation in throat. Co... Read more
Urticaria (on back of neck, bilateral arms), upper lip swelling and scratchy sensation in throat. Consistent with anaphylaxis.
31 2021-07-10 brain sinus blood clot, blood clot, cerebrovascular accident On the night of 4/26 I experienced the worst headache of my life and severe GI upset. The GI upset a... Read more
On the night of 4/26 I experienced the worst headache of my life and severe GI upset. The GI upset abated within 24 hours but the headaches persisted on and off for over a month until the night of 6/10, when, after sleeping for 25 hours, I was unable to talk. My partner took me to the ER where it was determined I was having a stroke. I was transferred to another hospital, where I was diagnosed with CVST/Thalamic Stroke and a thrombectomy was performed, followed by an angiogram later that week. As a result of my hypercoagulated state and the angiogram, I developed another clot in my right arm. I was on Heparin and then Coumadin, with Lovenox as a bridge. I just got out of rehab this week.
31 2021-07-12 cerebrovascular accident platelet count bottomed out; debilitating migraines; stroke like symptoms; unknown neurological diso... Read more
platelet count bottomed out; debilitating migraines; stroke like symptoms; unknown neurological disorder; not be able to walk without falling; This is a spontaneous report from a contactable other healthcare professional (patient). A 31-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Right on 25May2021 13:00 at age of 31-year-old (Lot Number: EW0173) at single dose for COVID-19 immunisation at facility pharmacy or drug store. The patient's medical history was not reported. There was no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient is not pregnant at the time of the vaccination. The patient's concomitant medications were not reported. There was no other vaccine within 4 weeks prior to the COVID vaccine. The patient previously took bnt162b2 dose 1 for COVID-19 immunisation. On 30May2021, her platelet count bottomed out, she had debilitating migraines that cause stroke like symptoms, she had an unknown neurological disorder that caused her to not be able to walk without falling, 2 hospital stayed. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, prolongation of existing hospitalization (vaccine received during existing hospitalization), life threatening illness (immediate risk of death from the event), disability or permanent damage. The patient was hospitalized for the events from May2021 for 5 days. It was unknown if any treatment was received for the events. The patient underwent lab tests and procedures which included platelet count: reduced, platelet count bottomed out on 30May2021, since the vaccination, the patient had been tested for COVID-19 via nasal swab in 2021 with unknown result. The outcome of the events was not resolved.; Sender's Comments: Based on the available information in the case, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events platelet count decreased, migraine, cerebrovascular accident, nervous system disorder and gait disturbance. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
31 2021-07-15 fluid around the heart Pt reports: "After receiving the Pfizer vaccine for my second round on 6/7/21. I had went to the h... Read more
Pt reports: "After receiving the Pfizer vaccine for my second round on 6/7/21. I had went to the hospital with extreme chest and side pain. I could not breathe or talk. They sent me home after a x-ray and blood work ruled out no blood clots. They assumed it was a bruised rib and heart burn. The pain got worse so I called my family doctor. She did a cat scan and found fluid built up around my lungs and heart. My heart showed inflammation as well. he stuck me on pain medicine. I now have to go get two different heart tests on 7/12/21 and 7/14/21. My family doctor told me that all these problems developed because of the vaccine"
31 2021-07-16 vaginal haemorrhage So basically at the seventh of July 2021, I had a pinkish red discharge. Then after the bleeding sto... Read more
So basically at the seventh of July 2021, I had a pinkish red discharge. Then after the bleeding stopped there was some brownish discharge and I went to the doctor, the doctor monitored me on July 8th, 2021, checking baby's heart and movement. They also checked my vagina and cervix to confirm there was no more bleeding at that time. They said I was okay and they not concerned about it. They also did a test of my urine and found nothing abnormal. I was at the doctor approximately three hours. This is my first child so I have not had any others. My date of delivery is September 21, 2021. The doctor I saw was a certified NP.
31 2021-07-17 blood clot The patient received first dose of bnt162b2 ((PFIZER-BIONTECH COVID-19 VACCINE, administered on Righ... Read more
The patient received first dose of bnt162b2 ((PFIZER-BIONTECH COVID-19 VACCINE, administered on Right deltoid on 06Jan2021 and Her second dose was 19Feb2021); The patient received first dose of bnt162b2 ((PFIZER-BIONTECH COVID-19 VACCINE, administered on Right deltoid on 06Jan2021 and Her second dose was 19Feb2021); superficial blood clot; This is a spontaneous report from a contactable other HCP. This 31-Year-Old female other HCP(patient) reported that she received second dose of bnt162b2 ((PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EK6201, Expiry Date: Unknown), via an unspecified route of administration, administered on Right deltoid on 19Feb2021 (vaccinated at the age of 31 years) as DOSE 2, SINGLE for covid-19 immunisation. The patient received first dose of bnt162b2 ((PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EK9231, Expiry Date: Unknown), via an unspecified route of administration, administered on Right deltoid on 06Jan2021 at 12:00 PM (vaccinated at the age of 31 years) as DOSE 1, SINGLE for covid-19 immunization. COVID-19 vaccine was administered in hospital. Medical history included varicose vein and allergy to Penicillin. Concomitant medication(s) received within 2 weeks of vaccination included buprenorphine hydrochloride, naloxone hydrochloride (SUBOXONE) and buspirone. The patient was not pregnant at the time of vaccination and at the time of report. Prior to vaccination, patient was not diagnosed with COVID. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. She was exposed to covid the same week, she was given the 1st vaccine. She was tested positive for covid via a nasal swab on 11Jan2021 and her 1st vaccine was given on 06Jan2021. Her second dose was 19Feb2021.On 21Feb2021 (2 days after the second dose), she developed her first superficial blood clot. Since then she had 4 total. The AE resulted in doctor or other healthcare professional office/clinic visit/emergency room/department or urgent care. Therapeutic measures were taken as a result of superficial blood clot. She had to have a laser vein treatment since. She also had multiple ultrasounds. She always had varicose veins but they had never given me any trouble until after the vaccines and covid. The outcome of event was unknown. Device Date : 23Jun2021 Information on lot/batch number was available. Additional information has been requested. Follow-Up (29Jun2021): Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of serious events thrombosis,Inappropriate schedule of vaccine administered and off label use cannot be totally excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
31 2021-07-19 excessive bleeding lesions in my mouth, painful, bleeding, and peeling
31 2021-07-19 blood clot Ok so well on May 15 I had a confirmed pregnancy test however on May 27, 2021 I had sharp pains in m... Read more
Ok so well on May 15 I had a confirmed pregnancy test however on May 27, 2021 I had sharp pains in my stomach. I passed blood clots. I went to the ER and they confirmed there was no fetus, and they did testing. It came back that I had passed the embryo. They performed some blood work, which included a test for antibodies and that came back elevated so therefore I was told to have Hashimoto's Disease. Prior to the vaccine I was not diagnosed, so this is the information that I have. The time of miscarriage, I would have been 5 weeks pregnant so it was considered an early pregnancy loss. So I have had one pregnancy three years ago and since then, I have been trying to get pregnant and through IVF. My estimated date of delivery would have been January 27, 2022.
31 2021-07-19 vaginal haemorrhage Increased menstruation; Abnormal vaginal bleeding.; This is a spontaneous report from a contactable ... Read more
Increased menstruation; Abnormal vaginal bleeding.; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: ER8732) via an unspecified route of administration in the left arm on 26Mar2021 at 16:00 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism and asthma. The patient was allergic to shellfish. The patient received unspecified medications within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 26Mar2021 at 18:00, the patient experienced increased menstruation during her regular cycle and her cycle was over but she was experiencing abnormal vaginal bleeding. The patient did not receive any treatment for the reported events. The clinical outcome of the events increased menstruation and abnormal vaginal bleeding was not recovered at the time of the report. No follow-up attempts are needed. No further information is expected.
32 2021-01-08 vaginal haemorrhage Patient is a 32 yo G2P1001 with EDD 5/2/2021 by 7w US. She had the first dose of the Pfizer Covid 19... Read more
Patient is a 32 yo G2P1001 with EDD 5/2/2021 by 7w US. She had the first dose of the Pfizer Covid 19 vaccination on 12/17/2020 at the Health Clinic and the second dose on 1/7/2021 at 1115 am. She began having abdominal pain and vaginal bleeding at 315 sm on 1/8/2021 progressing to a previable (22w2d) preterm birth at 739pm on 1/8/2021.
32 2021-01-10 deep vein blood clot Patient received her covid vaccine on 12/28/2020 in her left arm. Three days after vaccination she h... Read more
Patient received her covid vaccine on 12/28/2020 in her left arm. Three days after vaccination she had pain and swelling in her right arm. She was seen by a health care provider on 12/31/2020 and an ultrasound showed extensive deep venous thrombosis in the left arm. She was started on a blood thinner (eliquis). She had blood tests done on 1/1/20 and this showed leukocytosis. She was found to have acute myeloid leukemia and admitted to our service for treatment. We do not have blood tests prior to 1/1/20 so it is unclear when her leukemia started. Her deep venous thrombosis could be related to her acute leukemia but I decided to report it due to the proximity to the time of her vaccine. Her arm pain and swelling improved after administration of the blood thinner. She is currently being treated for her leukemia.
32 2021-01-11 anaphylactic reaction Started to feel lightheaded, weak, faint like I was going to pass out, heart rate increased, confusi... Read more
Started to feel lightheaded, weak, faint like I was going to pass out, heart rate increased, confusion, trouble speaking, brought to the ED, throat started to swell and started having thick spit and clearing my throat excessively. Diagnosed as anaphylaxis.
32 2021-01-11 blood clot Heavy period with more bleeding. And cramping and multiple clots
32 2021-01-11 vaginal haemorrhage G3 P1 mother, estimated gestational age of baby = 4 weeks. On day 4 post-vaccine (1/11/21) started w... Read more
G3 P1 mother, estimated gestational age of baby = 4 weeks. On day 4 post-vaccine (1/11/21) started with heavy bleeding and labs confirmed miscarriage.
32 2021-01-13 death One week after I was vaccinated, my partially breast fed infant daughter (DOB 10/02/2020) died in he... Read more
One week after I was vaccinated, my partially breast fed infant daughter (DOB 10/02/2020) died in her sleep on 11/28/2020. The cause of death is not known. I am reporting her death here because of the relative proximity of my vaccination and her death.
32 2021-01-13 excessive bleeding Approximately 5 days after administration at 6 weeks pregnant, I began bleeding. The following day (... Read more
Approximately 5 days after administration at 6 weeks pregnant, I began bleeding. The following day (6 days after administration) miscarriage was confirmed via ultrasound
32 2021-01-13 vaginal haemorrhage body aches headaches fever of 101.2 fatigue tiredness tachycardia reached 152 leg pain light vaginal... Read more
body aches headaches fever of 101.2 fatigue tiredness tachycardia reached 152 leg pain light vaginal spotting (not near my expected period dates)
32 2021-01-26 vaginal haemorrhage within 24 hours of the initial shot I began to experiencing spotting (intermittent vaginal bleeding)... Read more
within 24 hours of the initial shot I began to experiencing spotting (intermittent vaginal bleeding) for the next 3 days. I also experienced hypersensitivity in my breasts, especially my nipples. So much so that I could not allow running water from the shower to touch them or sleep on my stomach. This also started within 24 hours of receiving the first shot and lasted for 5 days.
32 2021-01-31 cardio-respiratory arrest Pt developed a rash all over body, mild SOB, and mild chest tightness approximately 20 minutes after... Read more
Pt developed a rash all over body, mild SOB, and mild chest tightness approximately 20 minutes after receiving the 1st dose of COVID vaccine. Her SpO2= 95% on RA, HR= 105, BP= 111/62. She was given 25mg of IM Benadryl by (RN); code blue called, and team evaluated patient and sent pt. to ER; pt. remained conscious throughout.
32 2021-02-17 vaginal haemorrhage Miscarriage: vaginal bleeding with clots and tissue within 1 week of a positive home pregnancy test,... Read more
Miscarriage: vaginal bleeding with clots and tissue within 1 week of a positive home pregnancy test, two days after vaccination. Blood HCG take once vaginal bleeding commenced was <5.
32 2021-02-18 blood clot, excessive bleeding experienced crippling lower abdominal pain followed by very very heavy bleeding and clotting; experi... Read more
experienced crippling lower abdominal pain followed by very very heavy bleeding and clotting; experienced crippling lower abdominal pain followed by very very heavy bleeding and clotting; experienced crippling lower abdominal pain followed by very very heavy bleeding and clotting; This is a spontaneous report from a contactable healthcare professional (patient). A 32-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; batch/lot number and expiration date unknown), via an unspecified route of administration in the left arm on 05Jan2021 10:15 at a single dose for COVID-19 immunization at a hospital. Medical history included idiopathic hypersomnia and allergies to eggplant. The patient has no covid prior to vaccination. Concomitant medications included methylphenidate hydrochloride (CONCERTA), methenamine, levonorgestrel (MIRENA), propranolol hydrochloride (PROPRANOL) and vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]). The patient had no other vaccine in four weeks. The patient previously took cefazolin and levaquin and experienced allergies to both. The patient has a Mirena IUD and never get her period at all. Within 6 hours of her first Pfizer injection (02Feb2021 16:00), the patient experienced crippling lower abdominal pain followed by very very heavy bleeding and clotting. Resolved within 48 hours as quickly as it came and didn't occur with second dose 1 week out. The patient was not tested for Covid post vaccination. The events were not treated. The outcome of the events was recovered on 04Feb2021. Information on the lot/batch number has been requested.; Sender's Comments: Based on available information and known drug profile it is unlikely that the reported events were causally related to BNT162B2. These are intercurrent conditions. A contributory role of the patient's Mirena IUD should be evaluated. Case will be reassessed if additional information is received. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
32 2021-02-24 vaginal haemorrhage Pregnancy history: 1 previous pregnancy with healthy full term vaginal delivery. No complications. ... Read more
Pregnancy history: 1 previous pregnancy with healthy full term vaginal delivery. No complications. Estimated due date: Sept, 23, 2021. Symptoms: vaginal bleeding starting Jan 26th. Progressing to miscarriage on 1/29/21
32 2021-03-04 anaphylactic reaction Systemic: Allergic: Anaphylaxis-Mild, Systemic: Allergic: Difficulty Breathing-Mild
32 2021-03-07 anaphylactic shock Severe Angioedema persisting, currently at 36 days after first dose.
32 2021-03-10 vaginal haemorrhage Vaginal bleeding started 24 hours after vaccination
32 2021-03-22 anaphylactic reaction Pfizer vaccine- unknown lot number and dose number Reaction documented: anaphylaxis, high
32 2021-04-02 anaphylactic reaction Systemic: Allergic: Anaphylaxis-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting /... Read more
Systemic: Allergic: Anaphylaxis-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Vomiting-Mild
32 2021-04-07 anaphylactic reaction Systemic: Allergic: Anaphylaxis-Mild, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Aller... Read more
Systemic: Allergic: Anaphylaxis-Mild, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Severe
32 2021-04-08 vaginal haemorrhage, blood clot I began to bleed and pass blood clots from my vagina; I began to bleed and pass blood clots from my ... Read more
I began to bleed and pass blood clots from my vagina; I began to bleed and pass blood clots from my vagina; This is a spontaneous report from a contactable consumer (patient). A 32-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in the left arm on 11Mar2021 01:15 (at the age of 32 years) (Batch/Lot Number: EN6208) as a single dose for COVID-19 immunisation. Medical history included birth control. Concomitant medications were not reported. The patient is not pregnant. On 13Mar2021 04:00, the patient began to bleed and pass blood clots from her vagina. The event blood clots was assessed as serious (medically significant). The patient visited the doctor for the events and the events were given treatment. The outcome of the events was not recovered.
32 2021-04-10 anaphylactic reaction Within 30 minutes I complained of feeling out of it. Zoning out and hallucinating. A few hours later... Read more
Within 30 minutes I complained of feeling out of it. Zoning out and hallucinating. A few hours later I was driving and had difficulty swallowing and breathing. 911 was called and I went to an unspecified hospital for anaphylactic reaction. I have never had anaphylactic reaction prior to this vaccine.
32 2021-04-10 grand mal seizure Thurs, 04/01/2021, She exhibited excitability episodes (no triggers) multiple times after vaccine, s... Read more
Thurs, 04/01/2021, She exhibited excitability episodes (no triggers) multiple times after vaccine, starting within 45 minutes. Fri, 05/02/2021, when she woke, she had first grand mal seizure in 4-5 years; called 911 EMS to ck her before driving her to urgent care. She was cked by Dr & no severe tongue injury noticed. He sent referral for neurologist to followup. Called her primary Dr. & was told Dr out for several days. Call back from another Dr who refilled ATAVAN script in case further seizures. Apt set w/neurologist, for Wed. 04/14/2021.
32 2021-04-12 anaphylactic reaction Rash and itching developed within 10 minutes; administered oral Benadryl. Anaphylaxis at 45 minutes;... Read more
Rash and itching developed within 10 minutes; administered oral Benadryl. Anaphylaxis at 45 minutes; administered 1 EpiPen at 45 minutes, 1 EpiPen at 50 minutes. Anaphylaxis subsided until 2 hours post-vaccination; administered an additional 2 EpiPens and an additional dose of oral Benadryl. Anaphylaxis did not return. Rash and itching were gone by hour 6 post-vaccine. Fever, chills, sore throat, anorexia, and lethargy developed 12-16 hours post-vaccine. Changes in sense of taste and smell developed 36 hours post-vaccine (could be related to seasonal allergies).
32 2021-04-12 grand mal seizure I got the vaccine on Thursday afternoon, and had a grand mal seizure on Sunday. I was taken to the E... Read more
I got the vaccine on Thursday afternoon, and had a grand mal seizure on Sunday. I was taken to the ER where I was given Ativan, and had blood and urine samples taken and a CT scan. All test results came back normal. I have a follow up appointment with a neurologist today (Tuesday 4/13).
32 2021-04-18 vaginal haemorrhage Was unknowingly pregnant at the time of first and second shot. Found out I was pregnant and miscarry... Read more
Was unknowingly pregnant at the time of first and second shot. Found out I was pregnant and miscarrying the day of the second shot (4/6/21). Don?t know if the vaccine caused the miscarriage but I thought i should report it. Started bleeding within hours of the second shot and blood tests on 4/15 and 4/17 showed I was losing the pregnancy.
32 2021-04-18 vaginal haemorrhage I previously reported swollen lymph nodes in my left arm but since the , April 9 I began spotting fo... Read more
I previously reported swollen lymph nodes in my left arm but since the , April 9 I began spotting for 3.5/4 days. The discharge was pink/red and jelly like. Was not free flowing or strong enough to fill a pad. I took two pregnancy tests and both were negative. Menstrual cycle: 03/28/21-04/01/21 Vaccine dose 2: 04/03/21 Spotting/bleeding: 04/09/21-04/12/21 Negative pregnancy tests: 04/12/21 & 04/15/21 *Predicted period: 04/26/21
32 2021-04-20 anaphylactic reaction On Sunday, 04/18, I went and received my second dose of the Pfizer vaccine at 12:30 pm on my left ar... Read more
On Sunday, 04/18, I went and received my second dose of the Pfizer vaccine at 12:30 pm on my left arm. It hurt much sooner than the first, within a couple hours. It hurt worse as well. The next morning was Monday. My arm was super sore. I work from home and went by my normal routine. Oatmeal with raspberries and blueberries. I eat this every day. I started work at 9 AM. Around 9:30 Am or so, I started having sneezing fits. Which I thought was annoying more than anything, but didn't think anything of it, until the fits developed into my hands itching, burning, turning red. I looked at my face and noticed it was red and swelling. I've had skin allergies before, but nothing outside of hives and maybe a little skin swelling. I have an allergy to bees. Worse that ever occurred was hives. This instance did not produce hives but a very beet red rash and swelling. Then very quickly after, my tongue started swelling and my throat started tightening. I called my mother as I noted this was life threatening and went to the ER. I was informed I had experienced anaphylaxis. My heart rate going in to the ER was 166. I have never experienced this in the 32 years I've lived before. I was administered an Epi and steroids. As soon as I realized what it was, even in my panic, I was lucky to make a judgment call to save my life. The doctor said to throw out the berries just in case. The odd thing is, I eat this every day...no issues. I realize it is rare for reactions to be delayed, but was made aware it is possible. I was not stung by anything to make this occur.
32 2021-04-20 pulmonary embolism, blood clot in lung One day after shot: body aches, pain In both legs. Three days after shot: pain in shoulder and upper... Read more
One day after shot: body aches, pain In both legs. Three days after shot: pain in shoulder and upper chest, particularly when inhaling Five days after shot: loss of voice, sharp shooting/crushing pain in left chest cavity, increased pain when breathing Six days after shot: diagnosed with Pulmonary embolisms in left lung, pleurisy, and inflamed lymph nodes near left lung.
32 2021-04-20 vaginal haemorrhage I am 3 months post partum. The day after I received my shot, my pelvic area had a odd feeling. Almo... Read more
I am 3 months post partum. The day after I received my shot, my pelvic area had a odd feeling. Almost like my uterus felt a dull very very mild pressure. Day 2 after receiving my shot, I started to bleed. I am exclusively breastfeeding and I have never had a period start this early with all of my other children. Normal is 7 plus months for me. This period was also not a normal period. I had zero cramps. I felt nothing. I never have had a period with zero cramps. Lasted for 7 days.
32 2021-04-29 blood clot 9 days after receiving the first dose of the Pfizer vaccine, the patient developed superficial throm... Read more
9 days after receiving the first dose of the Pfizer vaccine, the patient developed superficial thrombophebititis in her right lower extremity that extended despite compresses, elevation, and aspirin use. A 2nd ER visit showed clot above and below her knee and in her greater saphenous vein which is a risk for deep venous thromboembolism and she was started on rivaroxaban (anticoagulation).
32 2021-04-30 heart attack One month after the second vaccine, patient suffered a sudden heart attack. Patient has no heart con... Read more
One month after the second vaccine, patient suffered a sudden heart attack. Patient has no heart condition or any remarkable health issues at all.
32 2021-05-02 deep vein blood clot got my vaccine Saturday morning 4/24/21 - woke up in the middle of the night on Tuesday morning arou... Read more
got my vaccine Saturday morning 4/24/21 - woke up in the middle of the night on Tuesday morning around 2am to my lower left leg from the knee down cramped up. Woke up to the same pain and continued all day Tuesday to the point of not being able to walk well . Wednesday morning went to urgent care to be treated due to extreme pain. Did an ultrasound and they diagnosed me with DVT - found two blot clots in my left calf and back of the knee.
32 2021-05-02 vaginal haemorrhage Bleeding/spotting for 10 days following second dose
32 2021-05-05 brain sinus blood clot Patient got her second dose of the Pfizer vaccine on 4/20 and started to feel a headache come on and... Read more
Patient got her second dose of the Pfizer vaccine on 4/20 and started to feel a headache come on and believed it was due to a migraine. On 5/1 she went to her local ED and was given migraine treatment. She continued to have worse headaches and developed subsequent L homonomous hemianopsia, L sided weakness, and L sided neglect. She presented to the ED on 5/5 and was found to have cerebral venous sinus thrombosis confirmed by head CT. Other risk factors include active COVID-19 infection (unknown at time of vaccine administration) and OCP usage.
32 2021-05-07 brain sinus blood clot 2 days of headache, encephaloapthy, L arm weakness + paresthesia. CT head found Cerebral venous sinu... Read more
2 days of headache, encephaloapthy, L arm weakness + paresthesia. CT head found Cerebral venous sinus thrombosis with intraparenchymal hemorrhage transformation and developed seizures. currently on therapeutic heparin drip, lacosamide, and keppra
32 2021-05-09 vaginal haemorrhage This 32 year old black female received the Covid shot on 4/8/21 and went to the ED on 4/18/21 ... Read more
This 32 year old black female received the Covid shot on 4/8/21 and went to the ED on 4/18/21 with the following diagnoses listed below. Hemorrhage in early pregnancy, unspecified VAGINAL BLEEDING - PREGNANT
32 2021-05-11 cerebrovascular accident I had a small stroke 7 days after the vaccine. They did a million tests and found no cause other tha... Read more
I had a small stroke 7 days after the vaccine. They did a million tests and found no cause other than the vaccine time correlation...I?m a healthy 32 year old.
32 2021-05-11 blood clot My period was extremely heavy for a few hours on day two of my cycle. I couldn?t leave the bathroom,... Read more
My period was extremely heavy for a few hours on day two of my cycle. I couldn?t leave the bathroom, the blood was very thin and had lots of clots. It was just evacuating my body so quickly. Normally, my period is very consistently light. This has never happened to me in my entire 20 years of menstruating. It was painless, no cramps, just very heavy and then after a few hours of nonstop bleeding, it went back to normal. It?s almost like the entire living decided to shed in a few hours rather than the extended few days that it normally happens in. The whole cycle still only lasted a few days like normal, just those few hours were noticeably abnormally heavy.
32 2021-05-12 anaphylactic reaction 5 minutes after vaccination, I felt unwell. I sat with EMS that was onsite. HR was 160's, BP 160's s... Read more
5 minutes after vaccination, I felt unwell. I sat with EMS that was onsite. HR was 160's, BP 160's systolic. Right arm went numb in first 5 minutes and my face went numb after 15 minutes post injection. After sitting 45 minutes with EMS my vitals stabilized and no numbness present. I walked to the car, sat in the car for 10 minutes and then I went into anaphylaxis. My airways began to close. My husband got the EMS on site and I was taken by ambulance to the ER. I was given IM Benadryl in the ambulance. In the ER I was given IV Benadryl and IV steroids. After anaphylaxis event I had difficulty breathing for 3 weeks from enlarged lymph nodes. I had extreme shortness of breath for the 2 weeks following injection in that I had to crawl up the flight of stairs to the second level of our home. About the 3rd week after injection, I began having full body itching with no known stimuli. Only benadryl would treat it. I was on allegra or zyrtec daily. I would also develop 1 or 2 hives on my right arm. 4 weeks after injections I was reacting to food and drink. I could not drink alcohol- gin or vodka- it would result in full body itching and a few hives. I did a course of prednisone, and it decreased my allergic reactions and I felt almost normal for several months. On May 8th, 2021 I had be experiencing great stress since February from a family member's cancer diagnosis. I had a crying event and immediately after I had an allergic reaction to gin, which had not occurred since the course of steroids. Today is 5/13 and I have had 2 additional allergic reactions: one involving food and the other flowers. None of which I have ever been allergic to before. I have full body itching and I am now developing hives more often.
32 2021-05-12 transient ischaemic attack 3 days after 2nd vaccine I was sent to ER for a TIA
32 2021-05-14 cerebrovascular accident Had symptoms consistent with stroke; Headache on the right side of her head that was 10/10 in intens... Read more
Had symptoms consistent with stroke; Headache on the right side of her head that was 10/10 in intensity, attributed it to migraine; left sided weakness.; She could not move; Numbness/weakness on left side of face, left arm, and left leg that started; Numbness/weakness on left side of face, left arm, and left leg that started; Numbness/weakness on left side of face, left arm, and left leg that started; This is a spontaneous report from a contactable physician and consumer (patient). A 32-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: ER8734), via an unspecified route of administration, administered in Arm Right on 09Apr2021 12:00 as 2nd dose, single for COVID-19 immunization in a workplace clinic. Medical history included migraine, depression, asthma, and known allergy: sulfa from an unknown date. No COVID-19 prior to vaccination. Concomitant medications included fluoxetine hydrochloride (PROZAC); omeprazole (PROTONIX); ibuprofen all taken for an unspecified indication, start and stop date were not reported and an unspecified birth control medication. The patient previously took Tylenol, erythromycin, Levaquin, and Flagyl and experienced drug allergy. The patient previously received the first dose of bnt162b2 (lot number: EP7534) on 19Mar2021 12:00 PM on the left arm for COVID-19 immunization. On 09Apr2021, on the same day after receiving the vaccine, the patient had numbness/weakness on left side of face, left arm, and left leg. On 10Apr2021 20:30 the patient woke up with a headache on the right side of her head that was 10/10 in intensity attributed it to migraine and left sided weakness. Her symptoms persisted and she could not move, so she called her mother and had symptoms consistent with stroke called 911 and went to the hospital emergency room then was admitted to the stroke unit. The patient was hospitalized for 2 days from 10Apr2021 to 12Apr2021. The patient received TPA and supportive treatment in ICU Stroke Unit. The events were considered serious for hospitalization and life threatening condition by the reporter. The patient underwent lab tests and procedures which included computerised tomogram and magnetic resonance imaging both did not show ischemia or brain bleed on unspecified dates, headache pain assessment: 10/10 on 10Apr2021, Aptima SARS-CoV-2 assay via Nasal Swab: negative on 11Apr2021, COVID-19 PCR test via Nasal Swab: negative on 06May2021. The outcome of the events was recovered.; Sender's Comments: Based on information provided, the reported events more likely represent intercurrent medical conditions which are unlikely related to bnt162b2. The case will be reassessed once more information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
32 2021-05-14 excessive bleeding Spotting/bleeding sporadically for about 20 hours
32 2021-05-16 anaphylactic reaction Patient had anaphylaxis reaction to Pfizer ( LOT#: EW0176, EXP date: AUG2021)first dose. Vaccine adm... Read more
Patient had anaphylaxis reaction to Pfizer ( LOT#: EW0176, EXP date: AUG2021)first dose. Vaccine administered around 0855, approximately at 0904 patient reported difficulty breathing and reported it to (observer). Observer brought the patient to a patient care room and reported it to the team lead. Patient appeared flushed, Provider noted that the patient was holding her throat. EpiPen 0.3mL (Lot #0FM355 Exp: NOV2021) was administered at 0910 and held in patients left thigh for 10 seconds. Patient reported a burning sensation when Epipen was given. EMS was called at 0913 arrived at 0922. Patient reported lip tingling and chills after EPiPen was administered. Patient developed a horse like cough but was reporting that her ability to breath was getting better. Vital signs taken at 0908 BP: 124/84 HR:82 O2: 98%. Second Vital signs taken at 0920 BP: 124/84 HR:100 O2: 98%. Third set of vitals taken at 0930 BP: 130/88 HR: 102 SPO2: 98%. Patient transported to Hospital at 0932.
32 2021-05-16 vaginal haemorrhage The day following my vaccination (4/24/21) I awoke feeling completely nauseous and dizzy. Upon getti... Read more
The day following my vaccination (4/24/21) I awoke feeling completely nauseous and dizzy. Upon getting out of bed I immediately sat on the floor due to the extreme dizziness and fear of passing out I felt. After a few minutes in this state I vomited. I had a fever which I managed with Tylenol. I felt fatigued and weak the entire day. I ran a fever the entire day, again managing it with Tylenol. The following day (4/25/2021) my fever was gone and I felt better, however about midday I began experiencing cramps and vaginal bleeding. I was 5.5weeks pregnant with an estimated due date of 12/24/2021. I went to the ER with concerns of a miscarriage. Based on abdominal ultrasound and subsequent HCGquant testing over the next week it was determined I had encountered a miscarriage and lost the baby.
32 2021-05-17 anaphylactic reaction Systemic: Allergic: Anaphylaxis-Mild, Systemic: Allergic: Itch (specify: facial area, extremeties)-M... Read more
Systemic: Allergic: Anaphylaxis-Mild, Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Allergic: Itch Generalized-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Systemic: Allergic: Rash Generalized-Mild, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Systemic: Numbness (specify: facial area, extremities)-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: Swelling and tingling occured in tongue, lips and throat. Symptoms began to abate 3-4 minutes after administration of epinepherine (Epineperine 0.3 mg via autoinjector to the pt's left thigh at approximately 1730). Patient was taken to ER by EMS. EMS arrived at approximately 1737.
32 2021-05-18 ischaemic stroke patient experienced ischemic stroke next day
32 2021-05-18 vaginal haemorrhage The day after the second dose I had extreme fatigue and muscle aches. I felt better after two days a... Read more
The day after the second dose I had extreme fatigue and muscle aches. I felt better after two days and I just had some soreness in my arm. I am pregnant with twins and I experienced vaginal bleeding on 05/07/2021. It was determined that it was due to Placenta Previa. I was 14 weeks pregnant at the time. At the moment I have been advised to take it easy and the babies are fine. Due Date-10/30/2021 Pregnancy-Second
32 2021-05-19 fluid around the heart that evening developed fever and chills, the next day progressive malaise and lymphadenopathy. persi... Read more
that evening developed fever and chills, the next day progressive malaise and lymphadenopathy. persisted x 3 days, tmax = 102
32 2021-05-20 vaginal haemorrhage Patient is a G2P1, received her second Pfizer vaccine on 4/16/21. She began having bleeding on 5/19/... Read more
Patient is a G2P1, received her second Pfizer vaccine on 4/16/21. She began having bleeding on 5/19/21 and had a completed AB confirmed on USG 5/20/21. She was 6 4/7 weeks at the time of her miscarriage.
32 2021-05-23 blood clot Period clots that resemble miscarriage every 20 minutes for 4+ days
32 2021-05-24 deep vein blood clot DVT in Peroneal vein in left leg. diagnosed 05/24/2021. Went to ER with pain in left Calf. Pain onse... Read more
DVT in Peroneal vein in left leg. diagnosed 05/24/2021. Went to ER with pain in left Calf. Pain onset was 5 days prior to ER visit (05/19/2021).
32 2021-05-24 vaginal haemorrhage Patient is a 32yo G3 now P2102 with EDC 7/20/2021 who was admitted with vaginal bleeding at 31w1d on... Read more
Patient is a 32yo G3 now P2102 with EDC 7/20/2021 who was admitted with vaginal bleeding at 31w1d on 5/21/2021. She had an emergent C-section for presumed abruption with EBL 3700ml and subsequent diagnosis of DIC requiring mass-transfusion and ICU admission. Patient stabilized following transfusion, ultimately discharged from hospital 5/25/2021. Neonate died DOL#2 from prematurity/RDS/Anemia/suspected sepsis/metabolic acidosis/cardiopulmonary arrest..
32 2021-05-25 vaginal haemorrhage Spontaneous vaginal bleeding started 48 hours after first dose of vaccine. Last menstrual period fi... Read more
Spontaneous vaginal bleeding started 48 hours after first dose of vaccine. Last menstrual period finished on May 20th 2021, prior to the first Covid Vaccine dose on May 24th 2021.
32 2021-05-25 vaginal haemorrhage Extreme and sudden vaginal bleeding upon awaking the next day after the first dose; it seems like I ... Read more
Extreme and sudden vaginal bleeding upon awaking the next day after the first dose; it seems like I am on my period but 11 days early; This is a spontaneous report from a contactable consumer (patient). A 32-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot Number: En 0198), via an unspecified route of administration, administered in Arm Left on 03Mar2021 11:45 (at 32-years-old) as 1st dose, single for COVID-19 immunization. The patient medical history was not reported. Patient was not pregnant. Facility type vaccine: Health Clinic. Patient had no covid prior vaccination. Patient was not tested for covid post vaccination. No known allergies. Concomitant medications included metronidazole (FLAGYL). The patient experienced extreme and sudden vaginal bleeding upon awaking the next day after the first dose, on 04Mar2021 07:00. After the initial large amount of blood, it seems like she was on her period but 11 days early, which has never happened before. No other symptoms. No treatment given. The outcome of the events was not recovered.
32 2021-05-27 excessive bleeding some chest pain and gas starting on the 10th day; some chest pain and gas starting on the 10th day; ... Read more
some chest pain and gas starting on the 10th day; some chest pain and gas starting on the 10th day; got sharp abdominal pain during ovulation on the right side on 11th day after vaccine as well as bleeding during ovulation time on 13th day.; got sharp abdominal pain during ovulation on the right side on 11th day after vaccine as well as bleeding during ovulation time on 13th day.; dizziness; Fever of 102.3; chills; headache; bodyache; weakness; arm pain and swollenness near injection site for 2-3 days.; arm pain and swollenness near injection site for 2-3 days.; A little lymph node swelling in armpits; This is a spontaneous report received from a contactable consumer (patient). A 32-year-old female patient received BNT162B2, via an unspecified route of administration, administered in the left arm on 28Apr2021 17:15 (Batch/Lot number and expiry date were not reported) at 32 years-old as 2nd dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. No known allergies. The patient previously received BNT162B2, via an unspecified route of administration, administered in the left arm on 07Apr2021 17:45 (Batch/Lot number and expiry date were not reported) at 32 years-old as 1st dose, single for COVID-19 immunisation and experienced local pain and little bit of dizziness right after the vaccine. On 29Apr2021 02:45, the patient experienced got sharp abdominal pain during ovulation on the right side on 11th day after vaccine as well as bleeding during ovulation time on 13th day, dizziness, fever of 102.3, chills, headache, bodyache, weakness, arm pain and swollenness near injection site for 2-3 days, arm pain and swollenness near injection site for 2-3 days, a little lymph node swelling in armpits. In May2021, the patient experienced some chest pain and gas starting on the 10th day. The clinical course was reported as follows: Second dose - dizziness after vaccine, Fever of 102.3, chills, headache, body ache in the middle of the night after vaccine. Fever subsided after next day, headache and weakness persisted. Arm pain and swollenness near injection site for 2-3 days. A little lymph node swelling in armpits for next 5-6 days. Got ok after this. But again, some chest pain and gas starting on the 10th day, perhaps due to ovulation time. However, a striking note is that after almost 2 years got sharp abdominal pain during ovulation on the right side on 11th day after vaccine as well as bleeding during ovulation time on 13th day. Chest pain still lingering. Concerned that it is not a blood clot issue. Or that the vaccine is interfering with the hormonal system. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination and did not received any other medications within 2 weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events weakness, headache and chest pain was not recovered; Fever of 102.3 was recovering. The outcome of the other events was unknown. The following information on the lot/batch number has been requested.
32 2021-05-28 vaginal haemorrhage I take the Depo-Provera shot and do not have bleeding with periods. On the morning of 5/23/2021, I ... Read more
I take the Depo-Provera shot and do not have bleeding with periods. On the morning of 5/23/2021, I woke up and I was vaginally bleeding. I am cramping worse than normal and feeling worse than normal. I have been bleeding consistently since then. I am using regular size tampons and have had to change at least 3 times a day.
32 2021-05-31 cerebrovascular accident HA since first COVID vaccine then 5/28/2021 2nd vaccine 36 hours later onset of left arm weakness w... Read more
HA since first COVID vaccine then 5/28/2021 2nd vaccine 36 hours later onset of left arm weakness with subacute stroke of right temporal and occipital lobs and a second area within the right frontal lobe suspicious for infarct.
32 2021-05-31 vaginal haemorrhage, blood clot Significant vaginal bleeding and vaginal blood clots. Extremely heavy bleeding during mid-cycle (bet... Read more
Significant vaginal bleeding and vaginal blood clots. Extremely heavy bleeding during mid-cycle (between periods). No prior history of heavy bleeding nor any vaginal blood clots. Started approx 24 hours after first shot and continued for several days, with bleeding and clots. Scheduled virtual doctors visit immediately and followed up with in-person pelvic exam and ultrasound. Normal ultrasound results. Stopped birth control pills for several days, then restarted, then soon after changed to new birth control.
32 2021-06-01 vaginal haemorrhage The morning after receiving the COVID-19 vaccine I began experiencing vaginal bleeding. This lasted ... Read more
The morning after receiving the COVID-19 vaccine I began experiencing vaginal bleeding. This lasted approximately 5-6 hours, then started again the following day and lasted overnight, for approximately 12 hours. I was pregnant at the time of the vaccine being administered, just over 14 weeks. The day the bleeding stopped (day 3) was the first day of week 15. I contacted the on call OB who suggested I follow-up with my regular OB on Monday, or to go to the ER if it got worse. During the exam on 5/24/2021 the OB was unable to determine anything wrong with the placenta, baby or my heath and was unable to explain the bleeding other than a potential side effect of the vaccine.
32 2021-06-02 death 32 year old female received vaccines while pregnant with her 3rd child. Pt has asymptomatic Factor V... Read more
32 year old female received vaccines while pregnant with her 3rd child. Pt has asymptomatic Factor V Leiden. She delivered on 5/27/2021 and passed away on 5/31/2021.
32 2021-06-02 pulmonary embolism Pulmonary embolism; This is a spontaneous report from a non-contactable pharmacist. A 32-year-old fe... Read more
Pulmonary embolism; This is a spontaneous report from a non-contactable pharmacist. A 32-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0177; Expiration date was not reported) on 15May2021 (13:45) as a 1st dose, single dose, with route of administration unspecified, for COVID-19 immunization. Medical history included allergies to sulfa. The patient's concomitant medications were not reported. The patient was not pregnant at the time of vaccination. On 17May2021, the patient had pulmonary embolism. The event had resulted into an emergency room/department or urgent care. The patient had received enoxaparin (LOVENOX) as treatment for the event. The outcome of the event was recovering. The patient was not diagnosed with COVID-19 prior to vaccination, and had not been tested since the vaccination. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported event of pulmonary embolism due to temporal relationship. However, the reported event may possibly represent intercurrent medical condition in this patient. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including pulmonary angiogram, VQ scan, chest CT/MRI and coagulation panel, counteractive treatment measures and concomitant medications including any history of use of oral contraceptives. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
32 2021-06-02 low platelet count thrombocytopenia (plt 92 000); menorrhagia; anemia (Hgb 11.8); This is a spontaneous report from a n... Read more
thrombocytopenia (plt 92 000); menorrhagia; anemia (Hgb 11.8); This is a spontaneous report from a non-contactable physician. A 32-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 intramuscular, administered in arm left on 06May2021 07:00 (Batch/Lot Number: EW0T76) as single dose for COVID-19 immunisation. Medical history included acne. Historical vaccine INCLUDED 1ST dose of BNT162B2 (lot: ER8735) on 15Mar2021 via intramuscular in left arm for COVID-19 Immunization. The patient's concomitant medications were not reported. Patient experienced menorrhagia, thrombocytopenia (platelet 92 000), anemia (Hgb 11.8), all on 12May2021 with outcome of recovering. All events resulted in physician office visit. Treatment included iron supplement for anemia. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information available and a close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of thrombocytopenia. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
32 2021-06-06 death, pulmonary embolism Decedent passed 06/05/2021 at 1042 hours. Exam showed bilateral pulmonary emboli.
32 2021-06-08 atrial fibrillation I felt my heart beat in an irregular pattern (AFib) and even it detected by Watch.; I felt my heart... Read more
I felt my heart beat in an irregular pattern (AFib) and even it detected by Watch.; I felt my heart beat in an irregular pattern (AFib) and even it detected by Watch.; Date of start of drug: 01May2021, Dose Number: 1; Date of start of drug: 01May2021, Dose Number: 2; Date of start of drug: 01May2021, Dose Number: 1; Date of start of drug: 01May2021, Dose Number: 2; This is a spontaneous report from a contactable female consumer reported for herself. A 32-year-old (non-pregnant) female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0171, Expiration date: unknown), via unspecified route, administered in left arm on 01May2021 at 11:15 AM (at the age of 32-year-old) as 1st dose, single dose for COVID-19 immunisation. On the same day(01May2021), the patient received another dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0179, Expiration date: unknown), via unspecified route, administered in left arm on 01May2021 at (at the age of 32-year-old) as 2nd dose, single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had no history of allergies. No other vaccines were received within 4 weeks prior to Covid vaccine. Prior or post vaccination the patient has not been tested or diagnosed with covid 19. On 23May2021, at 11:45 am, 22 days after the vaccination, the patient experienced heartbeat in irregular pattern (AFib) and even it detected by her watch. The lab data includes heart rate monitoring on 23May2021. No treatment options were used for the event. The outcome of the events was unknown. No follow-up attempts possible. No further information expected.
32 2021-06-10 deep vein blood clot, pulmonary embolism Patient went to the ER on 5/28/2021 after 2 weeks of calf pain, found t have DVT/PE
32 2021-06-17 blood clot *** I received my vaccine in 12/20 and within 6 hours after first injection I had a bump on the Left... Read more
*** I received my vaccine in 12/20 and within 6 hours after first injection I had a bump on the Left inner heel of my foot. As the days continued I began to develop more bumps on Left heel that traveled to my right foot. In total I have 10 plantar warts that developed which has caused my to be temporarily disabled from work. Shortly after when I recieved my menstraul cycle, it was extremely heavy and full of large blood clots. This was not my baseline. we are in the month of June and I have had irregular periods ever since vaccine. In March 2020 I had a cardiovascular incident that resulted in a RIGHT BUNLE BRANCH BLOCK. I'm following a cardiologist. I have had multiple issues with my body ever since I received this vaccine and urge the public to please read and educate yourself before you get it. Im just now starting to experience tingling in my arms and legs. All of the issues Ive list are all AUTOIMMUNE ISSUES. This vaccine has destroyed my health and hijacked my immune system. PLEASE BEWARE!!!!!
32 2021-06-21 vaginal haemorrhage Abnormal vaginal spotting Shortness of breath Chest Tightness Irregular heartbeat
32 2021-06-29 vaginal haemorrhage N93.9 - Abnormal uterine and vaginal bleeding, unspecified
32 2021-07-11 heart attack I had severe chest pain from Tuesday evening- Friday and still have minor residual pain when I take ... Read more
I had severe chest pain from Tuesday evening- Friday and still have minor residual pain when I take a deep breath; I had severe chest pain from Tuesday evening- Friday and still have minor residual pain when I take a deep breath; The pain was so bad I thought I was having a heart attack. It was primarily on the left side of my chest and felt like a stabbing pain. I went to the dr that following week.; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 32-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: el1283), via an unspecified route of administration, administered in Arm Right on 02Feb2021 13:30 (at the time of vaccination 32-years-old), as a single dose for COVID-19 immunization. The patient's medical history included thyroid. The patient's concomitant medications were not reported. The patient had no known allergies from food sensitivities. Patient had no other vaccine in fourweeks and no other medications in twoweeks. Patient did not have covid prior vaccination and no covid tested post vaccination. On 02Feb2021, the patient experienced the pain was so bad i thought i was having a heart attack, it was primarily on the left side of my chest and felt like a stabbing pain, i went to the dr that following week (myocardial infarction) (medically significant); and i had severe chest pain from tuesday evening- friday and still have minor residual pain when i take a deep breath. The patient visited to Doctor or other healthcare professional office/clinic visit. The outcome of the event was unknown. Follow-up (14May2021): Follow-up attempts completed. No further information expected.
32 2021-07-17 excessive bleeding A week later, I also experienced some minor bleeding for about 6 hours; On the same day as my second... Read more
A week later, I also experienced some minor bleeding for about 6 hours; On the same day as my second dose of the Pfizer Covid-19 vaccine (12Jun2021), I experienced very, very heavy menstrual bleeding. The amount was similar to what is typical a few days after giving birth; This is a spontaneous report from a contactable consumer (reporting on herself). A 32-years-old female non-pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot number and Expiry date was not reported) via an unspecified route of administration, administered in left arm on 12Jun2021 09:45 (age at 32 years) as dose 1, single for COVID-19 immunization. The patients medical history include 7 weeks postpartum with second child at time of vaccine. No known allergies. No covid prior vaccination and the patient not tested for COVID-19. There were no concomitant medications. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot number and Expiry date was not reported) via an unspecified route of administration, administered in left arm on 22May2021 10:30 as dose 1, single for COVID-19 immunization. There was no other vaccine in four weeks, no other medications in two weeks. It was reported that on 12Jun2021, on the same day as my second dose of the Pfizer Covid-19 vaccine, patient experience very, very heavy menstrual bleeding. The amount was similar to what is typical a few days after giving birth. The bleeding lasted for a day and a half. A week later, I also experienced some minor bleeding for about 6 hours. On 12Jun2021, I was about 7 weeks postpartum. The outcome of event some minor bleeding for about 6 hours was recovered and the outcome of events very heavy menstrual bleeding and vaginal haemorrhage was unknown. Information on the batch/lot number has been requested.
32 2021-07-17 vaginal haemorrhage Gushing blood from her vagina; Extreme fatigue; Started cramping really badly; Stated that she has b... Read more
Gushing blood from her vagina; Extreme fatigue; Started cramping really badly; Stated that she has been having the worst period of her life; Cramps are so intense they make you sweat; This is a spontaneous report from a contactable consumer, the patient. This case is created for second dose. A 32-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0182), dose 2 via an unspecified route of administration, administered in arm on 01Jun2021 (at the age of 32-years-old) as a single dose for covid-19 immunization. There were no medical history and concomitant medications. Patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP8735), dose 1 via an unspecified route of administration, administered in arm on 11May2021 (at the age of 32-years-old) as a single dose for covid-19 immunization. There were no medical history and concomitant medications. No other products, patient history, investigation assessment were reported. The patient ever since she got the vaccine that she has been having the worst period of her life and was reported as worsened. Stated that if she knew this would happen she would have never got it. Is for the Pfizer Covid vaccine. A few days after the shot on the 01Jun2021 that it started and she was cramping really badly and gushing blood. Stated the cramps are so intense they make you sweat. She just started her period again and was experiencing the same thing. She had extreme fatigue. She stopped gushing blood two days ago when her menstrual cycle ended. Stated that she noticed the gushing blood during her period. She started spotting on 03Jun2021 and gushing blood on 04Jun2021. Stated that she recovered completely because her menstrual cycle stopped. The cramps feel like contractions and are so bad that they make her sweat. Later clarified that she was having these issues with the first dose but she wanted to document the start date as being after the second shot because she was not keeping track of all of this. None treatment was reported. Outcome of the event vaginal haemorrhage and sweaty was unknown; while that for others was not recovered.
32 2021-07-19 heart failure Employee reports hospitalization and new diagnosis of heart failure
32 2021-07-20 vaginal haemorrhage Patient had child via c-section on 6/9/2021. Received dose #1 of Pfizer 6/15/2021. Had normal post-... Read more
Patient had child via c-section on 6/9/2021. Received dose #1 of Pfizer 6/15/2021. Had normal post-partum bleeding. Second dose 7/6/2021. Approximately 7/7/2021 she started having increased vaginal bleeding, darker and with an odor following by intermittent generalized abdominal pain. Pain progressed to become constant and included low back pain and some nausea. OBgyn ruled out other causes of increased increased post-partum bleeding, suspected having early menses (though is breastfeeding) vs AE of recent Pfizer vaccines. On 7/14/2021 she had sudden severe abdominal pain, and was diagnosed with acute appendicitis in the ER (Presbyterian Dallas).
33 2021-01-05 anaphylactic reaction Anaphylaxis requiring epinephrine and ER visit, no hospitalization required
33 2021-01-07 anaphylactic reaction Anaphylaxis - started with metallic taste in mouth followed by tongue swelling and chest heaviness
33 2021-01-10 anaphylactic reaction Anaphylaxis within 5 minutes of dose given. Tachycardia 130-140s, hot body temperature, trouble swal... Read more
Anaphylaxis within 5 minutes of dose given. Tachycardia 130-140s, hot body temperature, trouble swallowing, lightheaded/dizzy, ekg changes, feeling like I was going to pass out even when in bed. IV fluids, benedryl, soul-medrol, famotadine and IM epi given.
33 2021-01-13 anaphylactic reaction Systemic: Anaphylaxis-Medium; symptoms lasted 1 day
33 2021-01-14 cerebrovascular accident Pfizer-BioNTech COVID- 19 Vaccine EUA Received communication that patient experienced a stroke and r... Read more
Pfizer-BioNTech COVID- 19 Vaccine EUA Received communication that patient experienced a stroke and received alteplase at a non-facility (Medical Center) 5 days after receiving COVID-19 vaccination.
33 2021-01-18 vaginal haemorrhage I had vaginal bleeding and receive a Ultra sound. Which I had a miscarriage. My estimated delivery ... Read more
I had vaginal bleeding and receive a Ultra sound. Which I had a miscarriage. My estimated delivery was August 25,2021.
33 2021-01-24 vaginal haemorrhage This a continuation from 1st dose on 1/14 exp heavy bleeding. I had a urgent visit on 1/15 since I h... Read more
This a continuation from 1st dose on 1/14 exp heavy bleeding. I had a urgent visit on 1/15 since I haven't had any bleeding.(estimated date of delivery 9/7/2021)
33 2021-01-25 deep vein blood clot, blood clot Blood clot, DVT of a ill art vein acute left
33 2021-01-28 death Patient received vaccine uneventfully with no acute concerns. Left clinic and by report went out wit... Read more
Patient received vaccine uneventfully with no acute concerns. Left clinic and by report went out with friends. Spoke to father on phone at or around 9:00 pm. Failed to show up to work and was found dead at home. Other details pending
33 2021-02-02 anaphylactic reaction I had a mild anaphylactic reaction five minutes after getting the vaccine. The hives and tight thro... Read more
I had a mild anaphylactic reaction five minutes after getting the vaccine. The hives and tight throat went away after several doses of medication. The redness and itching last 4-5 days. I had to stay on Benadryl and Zyrtec to help with the redness and itching. My job sent me to the ER to be monitored after getting the shot until I went home. The fatigue lasted for a whole week.
33 2021-02-03 vaginal haemorrhage Dose #1- 2 days after receiving my first covid 19 vaccine I had 2 days of scant/light vaginal bleedi... Read more
Dose #1- 2 days after receiving my first covid 19 vaccine I had 2 days of scant/light vaginal bleeding and lower back pain. Very abnormal because I have the Nexplanon implanted in my arm and may have 2-3 periods per year. Normally the periods I do have are heavier and last 3-5days. One week later I had about 3 days of left ovarian pain. Dose # 2- One day (which is today) after receiving my second vaccine I started with scant/ light vaginal bleeding and lower back pain. No ovarian pain yet.
33 2021-02-09 vaginal haemorrhage I was 6 weeks pregnant when I got my first dose of the vaccine. I spoke with my OBGYN prior to the ... Read more
I was 6 weeks pregnant when I got my first dose of the vaccine. I spoke with my OBGYN prior to the vaccine and she said it was safe t get. The day after the vaccine (2/4) I started having some vaginal bleeding, confirmed with ultrasound. This progressed to having a miscarriage, confirmed via ultrasound 2/9. My OBGYN said she does not think they are related, but there is no way to tell. Until 2/4, I had no issues with my pregnancy.
33 2021-02-09 vaginal haemorrhage noticed vaginal bleed (~1mL) appeared 3hours or so after vaccine received. Not pregnant and menstrua... Read more
noticed vaginal bleed (~1mL) appeared 3hours or so after vaccine received. Not pregnant and menstrual cycle not slated to start until 10 days later.
33 2021-02-16 anaphylactic reaction Pt developed an anaphylaxis reaction to vaccine with resultant "throat tightening" and voice changes... Read more
Pt developed an anaphylaxis reaction to vaccine with resultant "throat tightening" and voice changes. Epi administered. EMS was alerted and patient was transported to the hospital. Of note, prior to leaving she received benadryl.
33 2021-03-01 pneumonia pneumonia; Fever; chills; nausea; difficulty breathing; This is a spontaneous report from a contacta... Read more
pneumonia; Fever; chills; nausea; difficulty breathing; This is a spontaneous report from a contactable other HCP (patient). A 33-year-old non-pregnant female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EL3247), via an unspecified route of administration in the left arm on 21Jan2021 11:00 at a single dose for COVID-19 immunisation. There were no medical history and concomitant medications. The patient experienced fever, chills, nausea, pneumonia, and difficulty breathing on 11Feb2021 23:00 with outcome of recovering. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient was not diagnosed of covid prior vaccination. The patient underwent lab tests and procedures which included Nasal Swab test post vaccination: negative on 13Feb2021. Therapeutic measures were taken as a result of events (antibiotics, IV fluids, Tylenol). The patient received second dose (Lot Number: EN6201) on 12Feb2021 12:00 PM in the left arm.; Sender's Comments: There is a reasonable possibility that the events fever, chills, and nausea were related to BNT162b2 based on known drug safety profile. Based on the temporal relationship, the association between the events pneumonia and difficulty breathing with Bnt162b2 can not be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
33 2021-03-01 blood clot I ended my normally scheduled menstrual cycle on 02/06/2021, and exactly 6 days later (02/15/2021) ... Read more
I ended my normally scheduled menstrual cycle on 02/06/2021, and exactly 6 days later (02/15/2021) I had severe menstrual bleeding with blood clots that has continued to this day (03/02/2021). I went to urgent care and was prescribed Provera to stop the bleeding to no avail. I then proceeded to go to urgent care again because the bleeding had not stopped. At my second Doctors visit, I had an abdominal and a transvaginal ultrasound done, and both of them came back completely normal. I have now scheduled an upcoming obgyn appointment, but cannot be seen until 03/09/2021.
33 2021-03-11 anaphylactic reaction Anaphylaxis, lightheadedness 33F with hx epilepsy, asthma, and multiple food and drug allergies who... Read more
Anaphylaxis, lightheadedness 33F with hx epilepsy, asthma, and multiple food and drug allergies who reported that she was experiencing chest pain/heaviness as well as feeling warm and throat tightness shortly after receiving her first COVID vaccine.
33 2021-03-15 vaginal haemorrhage I have vaginal bleeding and then it stopped on its own after two weeks and the bleed healed up. Dr v... Read more
I have vaginal bleeding and then it stopped on its own after two weeks and the bleed healed up. Dr visit - no treatment - peri gestational hematoma. My due date is 9/18/2021; my second history - I have one living child.
33 2021-03-21 vaginal haemorrhage Began spotting 2 days after the vaccine, it progressed over two more days and just had first miscarr... Read more
Began spotting 2 days after the vaccine, it progressed over two more days and just had first miscarriage at 2AM on 3/22/2021
33 2021-03-30 death 3/16/21: Patient presented and was admitted through the ED for alteration in mental status and a tem... Read more
3/16/21: Patient presented and was admitted through the ED for alteration in mental status and a temperature of 99.9. Upon arrival, she was noted to be hypotensive, hypoxic on room air and tachycardia. History of cystic fibrosis double lung transplant high-grade cervical cancer receiving palliative chemotherapy. Palliative care patient was placed to DNR and DNR B comfort care palliative was called. Later patient deceased on March 18 6:18 PM. per the EUA, hospitalizations to be reported irrespective of attribution to vaccine
33 2021-03-30 grand mal seizure Grand mal seizure for 30 seconds occurring 20-30 minutes post-vaccine. No history of seizures in pas... Read more
Grand mal seizure for 30 seconds occurring 20-30 minutes post-vaccine. No history of seizures in past.
33 2021-04-02 cerebrovascular accident Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Abdominal Pain-Medium, Systemic: Fainting /... Read more
Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Abdominal Pain-Medium, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Severe, Systemic: Hypotension-Medium, Systemic: Nausea-Severe, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Stroke-Mild, Systemic: Tingling (specify: facial area, extemities)-Medium, Systemic: Vomiting-Mild
33 2021-04-06 death On the evening of 4/3/2021 the patient was at home, prone in bed, gasped suddenly and became unrespo... Read more
On the evening of 4/3/2021 the patient was at home, prone in bed, gasped suddenly and became unresponsive. EMS was called and unable to resuscitate. She expired.
33 2021-04-07 blood clot in lung PT HOSPITALIZED WITH BLOOD CLOTS IN LUNGS. DISCHARGED FROM HOSPITAL A FEW DAYS LATER.
33 2021-04-08 excessive bleeding I experienced a miscarriage that started with bleeding on 3/13 and was confirmed by ongoing hcg leve... Read more
I experienced a miscarriage that started with bleeding on 3/13 and was confirmed by ongoing hcg level tests starting on 3/17. I passed a lot of blood and blood tissue in an intense event on 3/16. I did not know I was pregnant at the time and was estimated to be around 9-10 weeks (due date around October 2021) based on hcg levels. I was also breastfeeding at the time of my vaccine. I was advised to go to the emergency room if certain conditions occurred including extreme pain -- I opted to go to Urgent Care that evening to get checked out and to get a blood hcg test. Urgent care was unable to do the blood test and they recommended I call my provider the next day or go to the Emergency Department if certain symptoms occurred.
33 2021-04-08 vaginal haemorrhage Adverse was vaginal bleeding the required an overnight observation stay with montoring. Had Blood co... Read more
Adverse was vaginal bleeding the required an overnight observation stay with montoring. Had Blood count, transvasginal ultra sound done, and CDC.
33 2021-04-11 deep vein blood clot, pulmonary embolism I'm not a medical professional, I'm reporting this due to the proximity in which the events occurred... Read more
I'm not a medical professional, I'm reporting this due to the proximity in which the events occurred. I am a 33 year female with no history or family history of blood clots. I received the 2nd dose of my Pfizer vaccine on Apr 2 and on Apr 5 I began experiencing pain in my right leg. I had not injured it, and by Apr 14 I felt compelled due to the increased pain to contact a medical professional. They ran a d-dimer and mine came back high at 0.89. I was instructed by my PAC to go to the ER and tell them about the elevated d-dimer results. At the ER they performed an ultrasound and confirmed "Acute occlusive deep venous thrombosis in the right calf involving the entire length of 1 peroneal vein.". They also performed a CT scan on my chest and discovered "Right lower lobe distal segmental and subsegmental pulmonary artery emboli". They also performed a series of blood tests, all of those came back fine. I am being treated with 15mg of rivaroxaban (Xeralto).
33 2021-04-11 vaginal haemorrhage 100 degree fever, persistent vomiting, chills, aches, loss of appetite, weakness, fatigue, unusual a... Read more
100 degree fever, persistent vomiting, chills, aches, loss of appetite, weakness, fatigue, unusual and heavy vaginal bleeding
33 2021-04-12 excessive bleeding I was approximately 6-weeks pregnant and suffered a miscarriage which began the following day after ... Read more
I was approximately 6-weeks pregnant and suffered a miscarriage which began the following day after receiving the vaccine. Symptoms presented as fever (100.4), severe cramping, diarrhea, bleeding, body aches & chills, which lasted Saturday & Sunday following the vaccine (received on Friday).
33 2021-04-13 grand mal seizure Noticed feeling extremely lethargic, heart rate increased, had grand mal seizure. Spouse said that t... Read more
Noticed feeling extremely lethargic, heart rate increased, had grand mal seizure. Spouse said that the event was not as long or aggressive as typical grand mal episodes. Previously seizure-free for over a year and a half. Last blood lamotrigine levels tested 3/02/2021 and was out of standard range on the low end. Dosage of lamotrigine increased to compensate (225 mg AM/200 mg/PM) after obtaining results. Dosage increased again (225 mg 2x/day) after seizure episode. Pending blood level retest in May. Event is likely due to low medicinal levels aggravated by immune response. First pregnancy, event occurred at 30 weeks gestation. Estimated delivery 6/17/2021. Seizure occurred in bed and no physical external damage happened to the abdomen. Fetal movement is typical and predictable.
33 2021-04-13 pulmonary embolism Chest and back pain - pulmonary embolism, overnight hospital stay, blood thinner
33 2021-04-13 blood clot Pain in calf, swelling in lower leg (left leg), weakness/numbing in that leg- led to blood clot diag... Read more
Pain in calf, swelling in lower leg (left leg), weakness/numbing in that leg- led to blood clot diagnosis.
33 2021-04-18 ventricular tachycardia Patient has history of period v tach. 9:26 Vtach. 0xygen 99%, heart skipping, bp 140/90 (normal rang... Read more
Patient has history of period v tach. 9:26 Vtach. 0xygen 99%, heart skipping, bp 140/90 (normal range (110/70) Some dizziness 9:35 BP 140/86 9:46 BP 130/96 P-100 with bcc skipped beat 9:55 Patient feels okay and dizziness has resolved. Cleared by Dr. Feels well enough to go home. Husband is paramedic so he will take her to the station for a cardio strip and she will go to ER if she feels unwell.
33 2021-04-21 vaginal haemorrhage reported to ED on 4/3 with miscarriage, abdominal pain, vaginal bleeding. I don't have the info on ... Read more
reported to ED on 4/3 with miscarriage, abdominal pain, vaginal bleeding. I don't have the info on date of delivery it isn't in the ED providers note.
33 2021-04-22 grand mal seizure About 10-12 hours after both vaccines I had Grand Mal seizures and several clonic seizures throughou... Read more
About 10-12 hours after both vaccines I had Grand Mal seizures and several clonic seizures throughout Sunday night/ Monday morning
33 2021-04-26 blood clot Heavy menstrual bleeding with clots; Heavy menstrual bleeding with clots; This is a spontaneous repo... Read more
Heavy menstrual bleeding with clots; Heavy menstrual bleeding with clots; This is a spontaneous report from a contactable nurse (patient). A 33-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date unspecified), via an unspecified route of administration, administered in left arm on 08Apr2021 13:00 as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was not pregnant and had no other vaccine in 4 weeks. On 08Apr2021 13:30, the patient experienced heavy menstrual bleeding with clots. There was no therapy for the events. The patient had no COVID prior vaccination and was not COVID tested post vaccination. Outcome of events was recovered on an unspecified date. Information about Lot/Batch number is requested.; Sender's Comments: Based on the available information the reported events were attributed to an underlying or an intercurrent medical condition and it is assessed as unrelated to the suspect drug bnt162b2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
33 2021-04-27 cerebrovascular accident Mini Stroke/blockage in left eye; Mini Stroke/blockage in left eye; Sore arm for 1 day after 1st dos... Read more
Mini Stroke/blockage in left eye; Mini Stroke/blockage in left eye; Sore arm for 1 day after 1st dose; Diagnosed with CRVO of the eye; This is a spontaneous report from a contactable consumer (patient). A 33-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN1199), via an unspecified route of administration, administered in left arm on 09Mar2021 12:30 (at the age of 33-years-old) as single dose for COVID-19 immunisation. The patient had no known allergy and no other medical history. The patient's concomitant medications were not reported. On 09Mar2021 the patient experienced sore arm for 1 day. She was diagnosed with CRVO of the eye. On 30Mar2021 she had mini stroke/blockage in left eye. Symptoms noticed about 1 week prior to 30Mar2021. The events resulted in Doctor or other healthcare professional office/clinic visit. The patient did not receive treatment for events. The patient did not have COVID prior vaccination and she was not COVID tested post vaccination. The outcome of events was not recovered.
33 2021-04-29 vaginal haemorrhage I got my first COVID shot when I was 5 weeks pregnant. Due date 12/14/21. It was a Tuesday afterno... Read more
I got my first COVID shot when I was 5 weeks pregnant. Due date 12/14/21. It was a Tuesday afternoon that I got the shot, and by Thursday morning around 0700, I had heavy vaginal bleeding and intense cramping. The bleeding and cramping lasted 2 days. My OB ordered an ultrasound on Friday, and thankfully baby had a heartbeat. My repeat ultrasound on 4/26 also showed that baby was growing and had a heartbeat. This is my fourth pregnancy, and I've never had any bleeding in my first trimester.
33 2021-05-02 blood clot heavy blood in stool and small blood clot passed with stool. blood with stool lasted for approximate... Read more
heavy blood in stool and small blood clot passed with stool. blood with stool lasted for approximately one week.
33 2021-05-02 blood clot Very heavy menstrual flow during the first cycle after vaccine, noticed small clots. This is a first... Read more
Very heavy menstrual flow during the first cycle after vaccine, noticed small clots. This is a first time ever for me. Also, longer menses than usual by a few days.
33 2021-05-03 blood clot The next day after I received the Pfizer vaccine I started feeling sick and lightheaded it had a hea... Read more
The next day after I received the Pfizer vaccine I started feeling sick and lightheaded it had a headache. I think nothing of it and then my menstrual cycle started early and it started off being heavier than usual. Then I notice when I went to wipe myself or use the bathroom blood clots was falling out. Being that I work in the medical field I know like if is not bigger than 1/4 there's nothing to really worry about. So as the day went on and the following days I noticed that the blood clots kept on getting bigger and bigger and coming faster and faster. At this point I started getting concerned, that's when I decided to go to the hospital. At the emergency room at Hospital they really didn't do nothing for me but gave me an ultrasound and gave me some birth control told me to follow up with my OBGYN. But I already made an appointment with OBGYN cuz I just feel like if something was going on and I can't get in to see them till June 30th. They did give me some birth control and tell me your help with the bleeding and for me to take some ferrous sulfate. They said they'd never heard of this reaction before. So I went on May 1st to get my second vaccine. Before I received it, I talked to doctor there and they told me it would be fine for me to get it. Now my symptoms and reactions are starting all over. I'm so concerned about what's going on with my body. I just need somebody to explain to me what's going on. I cannot afford another hospital ER bill again.
33 2021-05-04 excessive bleeding I am on hormonal birth control and I always start my period 3 days into the placebo pills. This mont... Read more
I am on hormonal birth control and I always start my period 3 days into the placebo pills. This month (2 weeks after the second dose) my period started before I finished the hormones. About 3 days before they were done. I also had noticibly more cramping and the bleeding was light but a very dark brown. I haven't done anything for it yet. I am monitoring it to see if it gets better or worse. I believe that maybe the vaccine did something to my hormones because the morning after Vax #2 my breasts and nipples were sore.
33 2021-05-06 deep vein blood clot I had DVTs in my right calf that landed me in the ER a week after my first shot.; This is a spontane... Read more
I had DVTs in my right calf that landed me in the ER a week after my first shot.; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 33-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in left arm on 03Mar2021 at 10:45 AM (Lot number: UNKNONW), at the age of 33 years, as a single dose for COVID-19 immunization. Medical history included protein C deficiency, drug hypersensitivity to Sulfa. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. There were no concomitant medications. The patient reported "I had DVT's in my right calf that landed me in the emergency room (ER) a week after my first shot on 08Mar2021. Therapeutic measures were taken as a result of "I had DVTs in my right calf that landed me in the emergency room (ER) and included blood thinning medication. The clinical outcome of DVT was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19. Information on the lot/batch number has been requested.
33 2021-05-10 vaginal haemorrhage Spontaneous vaginal bleeding similar to menstruation but not the same in consistency or occurrence
33 2021-05-12 cerebrovascular accident Early onset stroke at 33, drs could not determine a cause
33 2021-05-17 death Was told she died in her sleep. This is one of 3 nurses in the medical center that passed away sudd... Read more
Was told she died in her sleep. This is one of 3 nurses in the medical center that passed away suddenly. Vaccine roll out was December 2020, unknown exact date or type
33 2021-05-17 pneumonia, sepsis Pt admitted to hospital with Sepsis. Fevers and malaise for 1 day before admission. Extremely elevat... Read more
Pt admitted to hospital with Sepsis. Fevers and malaise for 1 day before admission. Extremely elevated WBC. New pneumonia. Requiring oxygen.
33 2021-05-17 vaginal haemorrhage Found out I was pregnant Feb 11th, 2021, the day before my second dose of covid-19 vaccination. Sta... Read more
Found out I was pregnant Feb 11th, 2021, the day before my second dose of covid-19 vaccination. Started bleeding February 22nd, 2021. Went to Emergency Room and was informed may be having a miscarriage. Persisted bleeding for a week. Visited an OB throughout that week and verified I was going through a miscarriage and was approximately 4-5 weeks. First pregnancy and only pregnancy.
33 2021-05-18 blood clot blood clot; Also have had neck pain since the first vaccine that will not go away; extreme pain in m... Read more
blood clot; Also have had neck pain since the first vaccine that will not go away; extreme pain in my left leg; unable to walk; This is a spontaneous report from a contactable consumer (patient) who reported events after first and second dose of the vaccine. This case is for events after the second dose. A 33-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number was not reported), via an unspecified route of administration in Arm Left on 31Mar2021 at 13:00 (at 33 years) for covid-19 immunization. Medical history included asthma. Concomitant medication included methylphenidate taken for an unspecified indication, start and stop date were not reported. The patient previously took the first dose of the vaccine on 03Mar2021 at 13:00 in Left arm for covid-19 immunization and had neck pain. On 19Apr2021 at 12:00 (also reported as 3 weeks after the final vaccination) the patient experienced suddenly extreme pain in her left leg and was unable to walk on it. Doctors found a superficial blood clot. Also had neck pain since the first vaccine that will not go away. Events required Doctor or other healthcare professional office/clinic visit and treatment (unspecified) was given. The final outcome of all the events was reported as recovering. Information on the batch number has been requested; Sender's Comments: Linked Report(s) : -PFIZER INC-2021523861 same patient/drug, different dose/event
33 2021-05-21 blood clot I had severe pain in my right shoulder for over 10 days my shoulder was so swollen I had to take Ibu... Read more
I had severe pain in my right shoulder for over 10 days my shoulder was so swollen I had to take Ibuprofen to take the swelling down in shoulder it felt like it was dislocated from its socket it was so swollen I have fibromyalgia already and had a terrible arthritis flare up as well after the vaccination and now I do have a another blood clot issue after getting my vaccination so not sure how I feel about getting the 2nd one my doctor told me to report this thank you
33 2021-05-22 blood clot Two weeks following vaccine I developed a superficial blood clot in my right cephalic vein. I am 33y... Read more
Two weeks following vaccine I developed a superficial blood clot in my right cephalic vein. I am 33yrs old, no comorbidities, no injuries. Not sure if the blood clot is related to the vaccine but I've been told it's worth mentioning.
33 2021-05-24 deep vein blood clot, pulmonary embolism Currently 36w pregnant, EDD is induction at 39 weeks. Presented with shortness of breath to OB and ... Read more
Currently 36w pregnant, EDD is induction at 39 weeks. Presented with shortness of breath to OB and sent to the ED, had a CT scan that confirmed extensive pulmonary embolisms including a saddle embolism. Further studies noted a DVT in my left thigh. I was also diagnosed with GDM a couple months prior but have been diet controlled with metformin. Am currently being treated with lovenox.
33 2021-05-24 excessive bleeding I had my second COVID vaccine on 4/2/21 and ever since then I have been bleeding. I take an oral con... Read more
I had my second COVID vaccine on 4/2/21 and ever since then I have been bleeding. I take an oral contraceptive. I reached out to my OB/GYN who suggested I stop taking them for about five days then restart the oral contraceptive a a double dose for five days. I was told to contact the office again if this did not stop the bleeding as I would need an ultrasound . It worked for about a week and now I?m bleeding again and will be contacting my doctors office.
33 2021-05-24 vaginal haemorrhage After receiving the vaccine I experienced vaginal bleeding that I didn't have before during my pregn... Read more
After receiving the vaccine I experienced vaginal bleeding that I didn't have before during my pregnancy. Also, feeling fatigue and needing to rest.
33 2021-05-24 vaginal haemorrhage Normal pregnancy before vaccination. After first dose I experienced vaginal bleeding and fatigue. Af... Read more
Normal pregnancy before vaccination. After first dose I experienced vaginal bleeding and fatigue. After I fatigue, really tired that I never felt before. Felt really tired for two weeks. I miscarried my pregnancy. Baby had no heart beat and not progressing.
33 2021-05-25 cardiac failure congestive, fluid around the heart From Infectious Disease provider consult note on 5/14/2021: On 5/9, she developed sore throat, sinus... Read more
From Infectious Disease provider consult note on 5/14/2021: On 5/9, she developed sore throat, sinus congestion, mild diarrhea, myalgia, and malaise. Over the next few days, developed increasing SOB and progressive orthopnea. On 5/13, she came to ED where she had temp of 101.9 and bilateral infiltrates on chest xray. Was given antibiotics and 1L of fluid and promptly developed apparent congestive heart failure. Cardiology consulted and TTE (5/13) showed severe global dysfunction w/ EF of 30%, moderate MR, and small pericardial effusion w/ no evidence of tamponade. Labs unremarkable except CRP 4.9, COVID neg (5/13 and 5/14), HIV, ANA, rheum factor, pregnancy neg. Diuresed w/ Lasix, but 12 hours into admission (on 5/13/21), worsened w/ temp 102.2 and increased pulm edema on CXR. Labs on 5/14/21 showed pH 7.06 due to acute AG acidosis, AKI 1.6, mild transaminitis, trop 4600, LDH<2250. Had cardiac cath on 5/13 that was normal. Patient was intubated, aspirated, and re-intubated. Transferred to Medical Center on 5/14/2021 for further advanced cardiac care. At that time, had severe cardiogenic shock and suspected viral illness resulting in viral myocarditis. From CSICU progress note 5/23/2021: Placed on ECMO on May 14th and decannulated on May 21st. Remains in ICU for ongoing balloon pump, ventilator, and CRRT requirement. Repeat TTE planned for 5/24/21. Continuing to wean toward extubation.
33 2021-05-26 vaginal haemorrhage I was not pregnant at the time of my first vaccine- I first tested positive on April 24, about 2.5 w... Read more
I was not pregnant at the time of my first vaccine- I first tested positive on April 24, about 2.5 weeks after my first vaccine. This is my first pregnancy. Estimated date of delivery is December 31, 2021. On May 3, I began spotting. I had an ultrasound where pregnancy was confirmed. On May 6 I began bleeding- I had another ultrasound that confirmed a subchorionic hematoma (SCH). Due to the level of bleeding and size of the SCH, as well as low progesterone and somewhat slow rising HCG levels (though not dangerously low), I was told to prepare for miscarriage. At a follow up appointment on May 13, one day after my second Pfizer vaccine, the ultrasound showed normal embryonic development and a heartbeat! Follow up appointment on May 20 showed continued normal development, as well as a collapsed and smaller SCH. I continue to have some light cramping and spotting. I do not have any reason to suspect that this even was a result of the vaccine- but as it (and my positive pregnancy test) took place during the vaccination process, I wanted to report.
33 2021-05-27 anaphylactic reaction Patient had a reaction to first Pfizer vaccine on 5-5-21 was treated and released with prescription ... Read more
Patient had a reaction to first Pfizer vaccine on 5-5-21 was treated and released with prescription for Prednisone. Patient was told by physician to receive her second dose but to pre-medicate with prednisone 50mg and Benadryl 25mg. Pt did as she was advised and received second Pfizer vaccine. She started exhibiting s/s of anaphylaxis within 5 minutes of the vaccine. Treated with 50mg benadryl and 2 epi pen injections of .3mg 5 minutes apart while awaiting EMS. Patient treated and released later in the day.
33 2021-06-01 vaginal haemorrhage N93.9 - Abnormal uterine and vaginal bleeding, unspecified
33 2021-06-02 blood clot Irregular menstruation and menorrhagia following COVID-19 vaccine on 4/28/2021. Had irregular break... Read more
Irregular menstruation and menorrhagia following COVID-19 vaccine on 4/28/2021. Had irregular breakthrough bleeding on 5/7 that lasted 3 days and then again on 5/20 - 5/27 that lasted greater than 7 days with very heavy clots which is irregular for patient. Patient convinced that it is due to COVID-19 vaccine. She reports compliance with daily OCP.
33 2021-06-08 low blood platelet count ITP; This is a spontaneous report from a contactable physician. A 33-year-old female patient receive... Read more
ITP; This is a spontaneous report from a contactable physician. A 33-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, on 14May2021 (batch/lot number was not reported), as unknown, single dose, at age 33 years old, for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. Medical history included systemic lupus erythematosus (reported as "h/o SLE0") from an unknown date and unknown if ongoing. The patient was not diagnosed with COVID-19 prior to vaccination. The patient's concomitant medications were not reported. On 18May2021, the patient experienced ITP (immune thrombocytopenia). The event required hospitalization on an unspecified date with duration 4 days. Treatment included Decadron 40 mg IV x 4 days. On 21May2021, the patient underwent COVID-19 nasal swab with result: negative. The patient recovered from the event on an unspecified date. Information on the lot/batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
33 2021-06-10 vaginal haemorrhage O20.0 - Threatened abortion "HREATENED MISCARRIAGE ABDOMINAL CRAMPING VAGINAL BLEEDING - PREGNANT
33 2021-06-19 heart attack Chest and left arm pain occurred the night of 6/18/21 with NSTEMI noted (elevated troponin with no a... Read more
Chest and left arm pain occurred the night of 6/18/21 with NSTEMI noted (elevated troponin with no acute ischemia on EKG). Thought to be from myocarditis. Patient started on aspirin and metoprolol as per Cardiology consult.
33 2021-06-20 anaphylactic reaction What happened on the day April 30th is about 5 minutes after the vaccination they had me laying down... Read more
What happened on the day April 30th is about 5 minutes after the vaccination they had me laying down already so I wouldn't pass out because I passed out on the first vaccine. I became very confused and disoriented and had brain fog that didn't go away for about 3 weeks (about the 16th of May), it lasted a really long time. I didn't know who I was or where I was and confused and on the edge of consciousness for about 45 minutes on that day. On May 13th I had a severe reaction to something and my throat closed up. Starting April 30th I had a severe cough that lasted most of May and my Doctor gave me an inhaler around the 20th of May. On May 13th I went to emergency room (they gave me Benadryl) and they couldn't find anything wrong with my heart or systems in general and kept me for observation. I then followed up with my Dr later on that week and they initially thought I had asthma and they gave me an EpiPen in case I had another reaction like that. After that I've had 5 times where I had anaphylaxis where I had to use the EpiPen and this is new because I haven't had anaphylaxis since I was 15. Around 17th of May my brain fog started lessening and I would have 1 anaphylaxis x reaction a week since then and I continue to see my Doctor. She said I may have a genetic mast cell disorder that was activated by the vaccine. I am now on a daily emergency inhaler and EpiPen.
33 2021-06-21 anaphylactic reaction I did an epi on myself and followed up in the Emergency Room and I was fine afterwards.
33 2021-06-28 heart attack By the evening of her immunization, she had developed fever to 101, chills, tachycardia, insomnia, n... Read more
By the evening of her immunization, she had developed fever to 101, chills, tachycardia, insomnia, nausea, and headache. The fever lasted only a couple hours. The following day she continued to feel bad and by Sunday she was better although still tired and weak without any appetite. She reports acute onset of burning midsternal chest pain and pressure sensation in her left arm. Pt admitted with NSTEMI. Pt had cardiac catheterization. She was treated for pericarditis.
33 2021-06-28 vaginal haemorrhage N93.9 - Abnormal uterine and vaginal bleeding, unspecified
33 2021-06-30 pulmonary embolism Headache, shortness of breath, difficulty breathing, fatigue from 6/12-6/18. Pulmonary embolism dia... Read more
Headache, shortness of breath, difficulty breathing, fatigue from 6/12-6/18. Pulmonary embolism diagnosis on 6/18
33 2021-07-02 pulmonary embolism I was diagnosed with a pulmonary embolism in each lobe of my right lung on 24May2021; This is a spon... Read more
I was diagnosed with a pulmonary embolism in each lobe of my right lung on 24May2021; This is a spontaneous report from a contactable consumer (patient). A 33-year-old female patient (not pregnant at the time of vaccination) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EL3247), via an unspecified route of administration in left arm on 25Feb2021 (at the age of 33 years old) as single for covid-19 immunisation. Medical history included brain tumor, chronic migraine, premature ovarian failure. The patient had known allergies to codene, dust, tree pollen. The patient received other concomitant medications in the past two weeks. The patient did not receive any other vaccines within four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient underwent lab tests and procedures which included nasal swab sars-cov-2 test: negative on 24May2021. On 24May2021, patient was diagnosed with a pulmonary embolism in each lobe of right lung. The event resulted in: Emergency room/department or urgent care, hospitalization. The patient was hospitalized for 9 days. The patient received treatment due to the event with placed on heprin, evaluated for additional clots. The reporter considered events as serious. Since the vaccination, the patient tested for COVID-19. The outcome of event was resolving.
33 2021-07-05 low platelet count patient developed severe thrombocytopenia (platelet count =10K)
33 2021-07-05 vaginal haemorrhage O20.9 - Vaginal bleeding in pregnancy, first trimester
33 2021-07-06 excessive bleeding 1st pregnancy, estimated delivery 09/27/2021. Have bleeding was hospitalized and monitored for 30 ho... Read more
1st pregnancy, estimated delivery 09/27/2021. Have bleeding was hospitalized and monitored for 30 hours. Concerned about early delivery such as 25 weeks.
33 2021-07-06 vaginal haemorrhage 1. June 24th (24 hours): Mouth lesions. Headache. Vaginal bleeding 2. Sunday June 27th (96 hours): S... Read more
1. June 24th (24 hours): Mouth lesions. Headache. Vaginal bleeding 2. Sunday June 27th (96 hours): Severe oral blistering and cheilitis. Odynophyagia. White plaques on tonsils. Painful lymphadenopathy in the neck. T max: > 38 degrees. Reduced to liquid diet. ER Visit Sunday June 27th. Provisional dx of HSV. But HSV swap negative. Sent home with supportive care. 3. Tuesday June 29th (134 hours): Virtual consult. Rx Magic mouth. Oral Rx for Valacyclovir. 2000 mg PO x 2 doses. 4. July 2nd: Lesion on lips still present. Some improvement in pain. 5. July 7th: Oral lesions gone. One crack/fissure in the lower lip remained.
33 2021-07-09 vaginal haemorrhage, blood clot VAGINAL BLEEDING, BLOOD CLOTS, HEADACHES, AND FATIQUE
33 2021-07-12 vaginal haemorrhage 3 days after 2nd dose I began to experience vaginal bleeding and ultimately 2 weeks later I had a mi... Read more
3 days after 2nd dose I began to experience vaginal bleeding and ultimately 2 weeks later I had a miscarriage. I had to have a D&C on 4/23 and still have been experiencing heavy bleeding
33 2021-07-17 blood clot Unusual and extremely heavy vaginal bleeding with clots. Now occurs every month for 2-3 weeks. Previ... Read more
Unusual and extremely heavy vaginal bleeding with clots. Now occurs every month for 2-3 weeks. Previous menses only happened 3-4 times a year for four days and was very light.
33 2021-07-19 vaginal haemorrhage I started bleeding heavily in the middle of the night, I was pregnant so it was really scary. I was ... Read more
I started bleeding heavily in the middle of the night, I was pregnant so it was really scary. I was taken in an ambulance to the hospital and I had an emergency C-section because I was bleeding so much. They found out that my placenta had torn away from the uterus which is why they had to take the baby out. That is called placenta abruption. I was 35 weeks pregnant. The baby was fine and I was in the hospital for like 5 days. I had hemorrhage too much like 2 liters of blood. I was not in labor really. I had pre-labor contractions but I was not in labor. My doctor told me that this happens sometimes and it is really rare. They did fetal monitoring, they tested the baby's umbilical chord for oxygen to make sure the baby did not suffered any oxygen deprivation and my baby was fine. After they delivered the baby everything was fine. Pregnancy history: everything was perfect before this, I actually had an ultrasound 2 days before this and everything was fine. This is my first baby. My baby was born 5 weeks early, so at 35 weeks. Estimated due date was 06/29/2021. Birth weight: 5 and a half pounds.
33 2021-07-21 low platelet count Pt developed thrombocytopenia to 8000. she was on cellcept and plaquenil at the time.
33 2021-07-22 pulmonary embolism I'm not sure if this is a result of the vaccine or not. Beginning 4/25/21, I had intense GI issues,... Read more
I'm not sure if this is a result of the vaccine or not. Beginning 4/25/21, I had intense GI issues, NVD, resulting in a trip to Urgent Care on 4/26. The PA thought it was gastroenteritis and to follow-up if I wasn't feeling well later in the week. The following Monday, I went to the ER as I wasn't better, had a CT scan which showed my appendix had burst and abscessed. I had an emergency laproscopic appendectomy on 5/3, released from the hospital 5/4. On 5/10 I felt a sharp pain in my lower back that I attributed to a pulled muscle. After several days of difficulty breathing, intense periodic back pain, I went back to the ER on 5/14 and I was diagnosed with a small PE in my right lung after CT scan.
34 2021-01-07 anaphylactic reaction Anaphylactic reaction 6 days post vaccine 24Dec2020; I had severe chest tightness; SOB; throat soren... Read more
Anaphylactic reaction 6 days post vaccine 24Dec2020; I had severe chest tightness; SOB; throat soreness; hoarse voice; mouth swelling; This is a spontaneous report from a contactable physician, the patient. A 34-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL0140), via an unspecified route of administration in the left arm on 18Dec2020 at 15:30 (at the age of 34-years-old) as a single dose for COVID-19 immunization. Medical history included severe dust mite allergy (based on skin test). Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included cetirizine hydrochloride (MANUFACTURER UNKNOWN), hydrocodone bitartrate/paracetamol (NORCO), ibuprofen (MANUFACTURER UNKNOWN), and ondansetron (ZOFRAN); all for unspecified indications from unknown dates and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 24Dec2020 at 10:00, 6 days post vaccination, the patient experienced anaphylactic reaction, severe chest tightness, shortness of breath, throat soreness, hoarse voice, and mouth swelling; all reported as life threatening. The events led to an emergency room visit and she was given epinephrine (EPI-PEN), methylprednisolone (SOLUMEDROL), and diphenhydramine hydrochloride (BENADRYL) as treatment. The patient stated that she developed the reactions 45 minutes after she took premedications for a dilatation and curettage procedure. The premedications included ibuprofen, hydrocodone bitartrate/paracetamol, ondansetron. She stated she had taken these medications several times before and this was the first time she had this reaction. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcomes of the anaphylactic reaction, severe chest tightness, shortness of breath, throat soreness, hoarse voice, and mouth swelling were recovered on unknown dates.; Sender's Comments: Anaphylactic reactions presented as chest tightness, shortness of breath, throat soreness, hoarse voice, and mouth swelling, developed 45 minutes after premedications including included ibuprofen, hydrocodone bitartrate/paracetamol, ondansetron for a dilatation and curettage procedure and 6 days post vaccination with BNT162B2, the event therefore is most likely attributed to these premedications unrelated to the vaccine use. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
34 2021-01-11 anaphylactic reaction -0715 vaccine administered. -0735 started to feel dizzy/off and right side of tongue felt like it wa... Read more
-0715 vaccine administered. -0735 started to feel dizzy/off and right side of tongue felt like it was mildly swelling and itchy. -0735 asked to have blood pressure taken as know when I am having anaphylaxis my blood pressure escalates. -0740 took blood pressure and it was 141/86 in right arm. Normal is 110s/60s-70s. No anxiety feelings. -0740 throat started to have increased mucous production. Had the tickle and tightness in throat. Asked and received 25mg Benadryl with cup of water. -0742 started clearing throat frequently and slight cough. Knew it was anaphylaxis and told the team I need to go to the ER. Asked for additional 25mg Benadryl. Also took 20mg Famotidine and 2 puffs Albuterol inhaler--this is my prescribed anaphylaxis routine. Had Epipens on standby. -0743 put on O2 saturation monitor and watched O2 drop into 90-92 range. Asked for epipen on standby as I know when I need to start it. Didn't want to take that when I knew I was about to get it in the ER and knowing self hadn't progressed that far. Felt chest tightness and shortness of breath. Voice started becoming hoarse. -0800 EMS arrived (delay as team didn't know if they were supposed to call 911 or a Code--they chose EMS even though in hospital). Then staff at COVID vaccine clinic kept emphasizing need to go in ambulance while EMS and self fought to go through hospital (much quicker route). Finally cleared to go through hospital to ER. To get some air via breathing in had to sit up leaning forward. Voice completely hoarse by this time. -About 0817 arrived to ER bay. At this time, frequently coughing and cough started to sound stridorous. Difficulty getting breaths in. Had chest pain near heart. Greeted by MD, 2 RNS, and technician. -0819 received IM epinephrine. Attached to 5 lead EKG monitoring and O2 monitoring. Blood pressure done again. Higher than previous. -About 0821 had working IV (previous two attempts failed as veins were constricting). Given IV Solumderol. Started bolus of 1L Normal Saline. -Not sure how long after by cough subsided, increased mucous production subsided, as well as hoarseness decreased. -Held for observation for 2hours (would be longer if not resolved). - Discharged around 1015. At this time, hoarseness almost all gone. Minimal throat clearing. Cough resolved. -Prescribed epipen inhalers (mine expired) and Prednisone. Prednisone is PRN for mild breathing difficulties if it starts again tomorrow 1/13/21. -At 1400 took 50mg Benadryl and 20mg Famotidine as previously prescribed for anaphylaxis maintenance. Will continue this as previously prescribed every 6hours until symptoms stay resolved. -Made follow up appointment with Primary Care Physician per protocol
34 2021-01-14 pneumonia 12/22 evening I had severe arm soreness and light body aches, the next morning I felt congestion, ru... Read more
12/22 evening I had severe arm soreness and light body aches, the next morning I felt congestion, runny nose , severe headache, mild palpitations, my whole body hurt. 12/24 I couldn't breathe through my nose at all , no taste or smell for 24 hours, 1 week after I wasn't getting better my lungs sounded junky , 12/31 I went to the urgent care, I got tested and was negative, I had pneumonia , I was sent home with antibiotic, steroids, inhaler.
34 2021-01-17 vaginal haemorrhage Vaginal bleeding/spotting/menstruation: on hormonal IUD and don't normally have any sort of period, ... Read more
Vaginal bleeding/spotting/menstruation: on hormonal IUD and don't normally have any sort of period, but started spotting ~24 hours after 2nd dose of COVID vaccine. Associated with headache and cramping
34 2021-01-23 grand mal seizure COVID-19 vaccination - 2/2 in series. Reportedly, patient fainted following first dose. Approximat... Read more
COVID-19 vaccination - 2/2 in series. Reportedly, patient fainted following first dose. Approximately 5-6 minutes after patient received second dose, she become lethargic, progressing to non-responsive. A rapid response was called and patient was transferred to the emergency department. She was protecting her airway. En route to the ED, patient's eyes rolled backwards and she began having generalized tonic-clonic movement indicative of a seizure. Patient was turned onto her side until seizure activity subsided. Post-ictal state lasted approximately 5-10 minutes after seizure activity ceased and patient became alert and oriented and able to answer all questions. All lab tests and imaging were normal.
34 2021-01-24 anaphylactic reaction Pfizer-BioNTech COVID- 19 Vaccine EUA EMS states "Pt received 1st covid vaccine dose at the clinic. ... Read more
Pfizer-BioNTech COVID- 19 Vaccine EUA EMS states "Pt received 1st covid vaccine dose at the clinic. Had an anaphylactic reaction, SOB, throat swelled, abdominal cramps. Received epi injection and 25mg benadryl. BP 150/70. Was tachycardic but HR currently in the 90's." Patient reports similar reaction when she received an allergy shot. ED Physician Note: "She was given her injection and then within about 2 minutes felt palpitations, lightheadedness, whole body numbness, an odd tongue sensation, and stomach cramping. She was given epinephrine and benadryl" Patient was discharged from ED same day with resolution of symptoms.
34 2021-01-28 vaginal haemorrhage Previously G1P1, delivered normal healthy baby July 20, 2020. Second pregnancy conception 12/15/2020... Read more
Previously G1P1, delivered normal healthy baby July 20, 2020. Second pregnancy conception 12/15/2020. First vaccine dose 12/22/2020. Vaginal bleeding started 1/2/2021 and tapered down 1/4/2021. Light bleeding continued 1/4/2021 - 1/18/2021. Second vaccine dose administered 1/12/2021. Bleeding increased from light/none to medium flow on 1/19/2021 - 1/22/2021. Home urine pregnancy tests positive x 2 on 1/22/2021. HCG 56 mIU/mL and progesterone 0.5 ng/mL on 1/22/2021. HCG 17 mIU/mL and progesterone <0.5 ng/mL on 1/25/2021. Bleeding decreased to light flow 1/22-1/25 and gone 1/26/2021. Dr. diagnosed as early pregnancy loss/miscarriage.
34 2021-02-12 anaphylactic reaction Patient received the Pfizer-BioNTech COVID-19 Vaccine EUA at 1006. Developed flushing tongue itching... Read more
Patient received the Pfizer-BioNTech COVID-19 Vaccine EUA at 1006. Developed flushing tongue itching, local redness on shoulders at 1010. Patient was given Benadryl 25mg po in the clinic and remained for observation. After observation, patient cleared to leave clinic - was instructed to call 911 and go to ED if exhibiting any signs or symptoms of anaphylaxis. Patient was given an extra dose of Benadryl, 25mg to take if needed.
34 2021-02-28 excessive bleeding COVID vaccine given Dec 24th, 2020 and second dose on Jan 16th, 2021. Conception occurred approx Ja... Read more
COVID vaccine given Dec 24th, 2020 and second dose on Jan 16th, 2021. Conception occurred approx Jan 11th, 2021 pregnancy diagnosed Jan 26th, 2021. ED Oct 4th, 2021. US confirmation of pregnancy with gestational sac on Feb 14th, 2021. Miscarriage/SAB/pregnancy loss occurred spontaneously on Feb 18th, 2021 with bleeding, cramping. Pregnancy loss confirmed by ultrasound with OBGYN.
34 2021-03-01 sepsis On 02.24.21 in the evening I began experiencing body aches. The following day I had a fever of 100.... Read more
On 02.24.21 in the evening I began experiencing body aches. The following day I had a fever of 100.8 and saw an Urgent Care provider who referred me to the hospital. Upon arrival my fever spiked to 102.3, bloodwork showed elevated lactate at 2.4 and pulse rate was over 119. I was admitted with sepsis symptomatology.
34 2021-03-09 low platelet count Onset of symptoms 1-2 days after 2nd Pfizer Dose. Presented to ER with fever, myalgia, headache, mil... Read more
Onset of symptoms 1-2 days after 2nd Pfizer Dose. Presented to ER with fever, myalgia, headache, mild thrombocytopenia/leukopenia, elevated hepatic function test. Also noted mild swelling of upper eyelids.
34 2021-03-13 vaginal haemorrhage Heavy vaginal bleeding beginning on cycle day 7 (period not due for 3+ weeks - very, very unusual f... Read more
Heavy vaginal bleeding beginning on cycle day 7 (period not due for 3+ weeks - very, very unusual for me).
34 2021-03-14 pulmonary embolism Pulmonary embolism: vaccine shot 2 administered 3/8, symptoms (shortness of breath, rapid heart beat... Read more
Pulmonary embolism: vaccine shot 2 administered 3/8, symptoms (shortness of breath, rapid heart beat) began 3/10, diagnosed at medical center 3/12. (Also experienced typical"flu like" symptoms beginning 12 hours after vaccine and lasting ~48 hours.) Being treated with anticoagulants.
34 2021-03-14 blood clot I received my first dose Pfizer vaccine on 03-09-2021. I have a history of blood clot, 10 years ago.... Read more
I received my first dose Pfizer vaccine on 03-09-2021. I have a history of blood clot, 10 years ago. I am currently 9 weeks pregnant. I called my doctor's office who encouraged me o go to the ER since I was having symptoms of a blood clot. I went to the emergency room at Hospital where they did some blood testing. I then went to Hospital where they did more lab work and blood testing, they did an D-dimer test ad my level was at 3.23 and explained to me it could be due to my pregnancy. They ran some more tests showing I have a clot in the superficial femoral/ popliteal vein. They placed me on Lovanox medication for two days. I will be seeing a maternal fetal doctor tomorrow for further evaluation. They also monitored my baby and baby is doing fine.
34 2021-03-21 deep vein blood clot Saturday night (3/13/21) and into Sunday morning (3/14/21), patient began feeling discomfort in lowe... Read more
Saturday night (3/13/21) and into Sunday morning (3/14/21), patient began feeling discomfort in lower right leg. Discomfort and feeling of swelling continued through Sunday evening. Monday (3/15/21) patient began using compression stocking and elevating leg, which eased some discomfort. Slight swelling, discomfort, and heat in the leg continued throughout entire week. DVT presumed. Contacted physician. Treatment for DVT and treatment dosage (Fondaparinux 7.5mg) commenced Wednesday (3/17/21) through to date. Discomfort has dissipated but slight swelling still remains. Appears to be getting better each day, although a very slow progression. Patient history of antiphospholipid syndrome has been managed for over fifteen years with blood thinners. Onset of a clotting event always followed a justifiable cause. No spontaneous/unexplainable clotting events to date. Patient otherwise healthy without any other current event which could explain a blood clot following vaccination. Reporting this information as it may be helpful in determining whether persons with APS or similar condition should receive Covid-19 vaccination. Note: this information being provided by patient.
34 2021-03-22 anaphylactic reaction Anaphylaxis.
34 2021-03-23 anaphylactic reaction Anaphylactic reaction, throat closing.
34 2021-03-30 grand mal seizure Administered Pfizer 2nd dose to patient at 1542 hrs. After injection was complete, patient's body w... Read more
Administered Pfizer 2nd dose to patient at 1542 hrs. After injection was complete, patient's body went limp, and began to exhibit a tonic/clonic seizure for approx. 5 seconds at 1545 hrs. Patient became limp and I assisted her to the ground safely. Patient came to, no postictal state, A/Ox3, and does not recall seizing. EMS activated approx. 1553 hrs, and Engine 16 arrived on scene approx. 1556 hrs. VS (sitting) @ 1559 hrs: 90/53, 60 bpm, 100% room air. VS (standing) @ 1605 hrs: 101/60, 64 bpm, 100% room air. Patient went into M-14 ambulance for additional monitoring. No medications given. Patient AMA with M-14 and left with husband with husband driving at approx. 1630 hrs.
34 2021-04-01 blood clot hemorrhagic bleeding (period), blood clot via bleeding. 1 week of bleeding, required transfusion cbc... Read more
hemorrhagic bleeding (period), blood clot via bleeding. 1 week of bleeding, required transfusion cbc/esr/crp. now have +factors for antiphosophlid syndrome along CCP. along w/ joint pain in her right hands, fingers and right knee. have swelling to the fingers.
34 2021-04-03 vaginal haemorrhage no history of miscarriage until the most recent pregnancy with the COVID vaccine. I previously had 4... Read more
no history of miscarriage until the most recent pregnancy with the COVID vaccine. I previously had 4 healthy pregnancies and 4 living children (now 5 pregnancies and 4 living children). I conceived on 12/18/2020 the day after I received my 1st covid vaccine. I began spotting blood on 3/7/2021 and miscarried an approximately 7 week old embryo. I had a D & C procedure to remove the baby that stopped growing weeks before ( I was 14 weeks and 1 day into my pregnancy before the miscarriage).Due date was sept 4th 2021.
34 2021-04-04 blood clot in the brain Fever 103 3/27, stomach pain, vomiting, diarrhea, headache, chest pain, SOB Hospital 3/29, criticall... Read more
Fever 103 3/27, stomach pain, vomiting, diarrhea, headache, chest pain, SOB Hospital 3/29, critically low potassium, D-Dimer elevated, chest CT clear, admitted 3/30 HIDA scan, gallbladder removed 3/31 woke with vision issues, seeing multiples of things, slanted hallways, can?t stay awake 4/1 CT and MRI of brain show venous blood clot Started on blood thinners, stopped birth control (had only been on birth control about 5-6 months)
34 2021-04-04 blood clot injection received 3/31/2021 at 12:55 pm. no event until next morning, noticed spotting, menstrual b... Read more
injection received 3/31/2021 at 12:55 pm. no event until next morning, noticed spotting, menstrual bleeding. heavy bleeding started 4/2/2021, 12-13 days before any menstruation expected. VERY SEVERE mental health issues, sadness, hopelessness, irritibility that I do not normally experience with PMS normally. I also am extremely regular with my menstruation and have tracked my period for years, and it is always consistent. as of 4/5 still having very heavy bleeding and clotting, some cramping. bleeding is showing no signs of letting up and my period expected start date is around 4/13. I almost didn't want to say anything because it could be chalked up to hormones or stress but this has not happened to me before, and the emotional state I was in was very bad, not even taking into account the bleeding. I am a very pro science and pro data person so I was hesitant to mention anything at all, but feel like IF this is related this could be a huge risk for folks who have a history of depression and anxiety or post partum conditions. The best way I can describe it was deep hopelessness, something I had not felt since having post partum depression when my daughter was born, 7 years ago.
34 2021-04-05 deep vein blood clot DVT blood clot in leg. Not able to seek care due to high deductible health insurance. Swelling, pain... Read more
DVT blood clot in leg. Not able to seek care due to high deductible health insurance. Swelling, pain, discoloration, bruising in lower leg below soleus muscle and deep pain in calf. Using compression, ice, elevation, massage and aspirin regimen.
34 2021-04-10 heart attack 1630: Participant presented after getting stuck twice by vaccinator and questioned if she received t... Read more
1630: Participant presented after getting stuck twice by vaccinator and questioned if she received two doses of the vaccine. Per the vaccinators, this participant was the sixth and final dose of the vial. Vaccinator initially went to administer the dose and noted that there was nothing in the syringe when he went to push the plunger. After reviewing the vial with the pharmacy staff, there is still vaccine in the vial with enough volume for a possible seventh dose. With this information I discussed with the participant that participant did not receive two doses. Participant started crying and developing chest pain which prompted an evaluation by EMS team in house at the vaccination center. Due to chest pain, she was given nitroglycerin x 1, and sent to local hospital via ambulance for further evaluation. We received report from hospital that participant had an MI and was sent to catheterization lab.
34 2021-04-11 excessive bleeding Woke up the next morning and had my period. I have an IUD and have not had a full on period in about... Read more
Woke up the next morning and had my period. I have an IUD and have not had a full on period in about two years. Am now on day 2 of noticeable bleeding. Also had some menstrual symptoms return that I have not had since the IUD was inserted (cramps, bloating).
34 2021-04-13 anaphylactic reaction 1 April, woke up at 0800 with slight headache and felt fatigued but most noticeably my voice sounded... Read more
1 April, woke up at 0800 with slight headache and felt fatigued but most noticeably my voice sounded weird and my throat was extremely hoarse while talking in work meeting and I had to constantly cough to clear it. I was having a bit of trouble swallowing as well. In the afternoon, my headache got worse and I had diarrhea. Around 7:45pm I started feeling extreme itchiness and swelling in my tongue. This didn't improve, so I took 25mg Benedryl at 8:20pm, at which time my vitals were normal, but noticeably lower than usual with a HR of ~60, BP of 100/70, O2 sat 99% and normal temp. I also took another 1000mg Tylenol at 9:30pm and went to bed. 2 April, 0730 woke up and my throat and tongue started swelling again and were very itchy. I began have difficulty breathing and swallowing saliva. I also could not swallow a banana easily, so I stopped eating it. I also had some wheezing that would only go away with a cough. Took 25mg more of Benedryl and went to urgent care immediately because breathing was becoming increasingly difficult. Treatment: At urgent car I was diagnosed with anaphylactic reaction due to vaccination and given another 25mg Benedryl injection and 10mg Prednisone. Vitals were BP:144/90, HR:83, TMP 98.5. Doctor considered epinephrine instead of Benedryl but "didn't want to have to send me to the ER". I was monitored for about 45 minutes and while my difficulty breathing did not improve much, it also did not worsen. I was sent home with Medrol steroid pack, Atarax and an EpiPen. My breathing ability did not return to normal until about ~3 days later.
34 2021-04-17 cerebrovascular accident Verterbal artery dissection that caused a stroke Very sharp neck pain, tingling on left side, dizz... Read more
Verterbal artery dissection that caused a stroke Very sharp neck pain, tingling on left side, dizziness, nausea (this went on for about 20 minutes prior to getting to the hospital)
34 2021-04-20 deep vein blood clot Right calf deep vein thrombosis
34 2021-04-21 vaginal haemorrhage Rash located on legs. The rush is purple. Palpable purpuric papules distributed on the left anterior... Read more
Rash located on legs. The rush is purple. Palpable purpuric papules distributed on the left anterior medial distal thigh and legs. The rash has been present for 6 weeks after the first vaccine injection, and got significantly worse after the second injection. Dermatologist diagnosed LCV related to COVID vaccination. Besides purpura, internal bleeding (vaginal and urinal) has occurred right after the 2nd dose and persisted for for 6 days.
34 2021-04-22 pulmonary embolism Beginning at approximately 9pm on 04/03/21, spasm like pain under back right ribs, radiating around ... Read more
Beginning at approximately 9pm on 04/03/21, spasm like pain under back right ribs, radiating around under ribs and up into right shoulder and right arm. Diagnosis in 4/7 was acute pulmonary embolism in right lung.
34 2021-04-24 excessive bleeding This is a spontaneous report from a contactable consumer. A 34-year-old female (patient) (pregnant) ... Read more
This is a spontaneous report from a contactable consumer. A 34-year-old female (patient) (pregnant) received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: ER8734), via an unspecified route of administration administered in left arm on 10Apr2021 as single dose for COVID-19 immunisation. The patient LMP Was on 24Feb2021 and 5 weeks of gestational period. Patient medical history included Known Allergies: Penicillin. Concomitant medications included Prenatal vitamins within 2 weeks of vaccination. There were no allergies to medications, food, or other products. Known allergies to Penicilin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 12 Apr2021, 48 hours after the vaccine patient started bleeding that has progress from a brown color to a bright red and from a small amount to a moderate amount for 5 days. The adverse event resulted in emergency room. The outcome of the event hemorrhage was not recovered and other event was unknown.
34 2021-04-25 pulmonary embolism Pulmonary embolism. Admitted 4/16 overnight for chest pain. Found to have PE.
34 2021-04-27 anaphylactic reaction Severe anaphylaxis, requiring epinephrine drip and stay in ICU, now resolved.
34 2021-04-27 excessive bleeding, blood clot First period after vaccine was very. very heavy! I was sent to the ER due to big clots and significa... Read more
First period after vaccine was very. very heavy! I was sent to the ER due to big clots and significant blood loss. Period started a week early on 4/22 and is still going on. Usually done within 5 days and not nearly as heavy with clots like this. ER suggested I report a possible correlation between that and the vaccine as they have seen it with other patients as well. ER doctor medicated with birth control hormones to slow down bleeding.
34 2021-04-27 blood clot Blood clots; headache; nervousness; anxiety; This is a spontaneous report from a non-contactable con... Read more
Blood clots; headache; nervousness; anxiety; This is a spontaneous report from a non-contactable consumer (patient). A 34-year-old female patient not pregnant received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 03Apr2021 09:00 (Lot Number: ER8733) as single dose (at the age of 34-years-old) for covid-19 immunisation. Medical history included allergies (known allergies: yes). Concomitant medications in two weeks prior to the vaccination included vitamin B complex (B-COMPLEX), magnesium (MAGNESIUM), chlorophyll (CHLOROPHYLL), vitamin D NOS (VITAMIN D NOS). Patient did not receive other vaccine in four weeks prior to the COVID vaccine. It was unknown if patient had COVID prior vaccination. Patient was not tested for Covid post vaccination. On 03Apr2021 patient experienced blood clots, headache, nervousness and anxiety. Events resulted in Doctor or other healthcare professional office/clinic visit. No treatment was required. Outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the available information, the known safety profile and the temporal association of BNT162B2 administration to the event of Thrombosis, a possible contribution of the drug to the event cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
34 2021-04-27 blood clot First day of period marginally heavier, accompanied with 2 large blood clots. First day of period is... Read more
First day of period marginally heavier, accompanied with 2 large blood clots. First day of period is always light & clots are not typically found until day 3+ of menstrual cycle. Will continue to monitor menstrual cycle at home.
34 2021-04-27 blood clot Developed blood clot in right leg (behind knee); This is a spontaneous report from a contactable con... Read more
Developed blood clot in right leg (behind knee); This is a spontaneous report from a contactable consumer (patient). A 34-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided), via an unspecified route of administration, administered in Arm Left first dose on 26Feb2021 11:15 at single dose for covid-19 immunisation. The patient's medical history included Developed blood clots after twin c section. The patient has been off blood thinners for 2.5 years. The patient was not pregnant at time of vaccination. The patient's concomitant medications included venlafaxine hydrochloride (EFFEXOR) and vitamin d [vitamin d nos]. On 17Mar2021, the patient Developed blood clot in right leg (behind knee). The patient was put on blood thinners as treatment. The events cause the patient emergency room visit and physician office visit. The outcome of the event was recovering. Information on the lot/batch number has been requested.
34 2021-04-28 anaphylactic reaction Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: A... Read more
Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Fainting / Unresponsive-Severe, Additional Details: 5 Min after vaccine had difficulty swalling and was given benadryl. Symptoms kept worsening and so given adult epipen. Then 3 min later she passed out and was out 10 sec. She maintained good pulse and breathing. EMS was called and arrived. When EMS arrived patient was conscious. She did leave with EMS.
34 2021-04-28 excessive bleeding On April 3 symptoms of miscarriage (pain, bleeding began). Was approximately 8 weeks pregnant. Symp... Read more
On April 3 symptoms of miscarriage (pain, bleeding began). Was approximately 8 weeks pregnant. Symptoms worsened across next week. Miscarriage was confirmed by sonogram + quantitative HCG levels, resulting in a D&C on 4/14 to evacuate remaining uterine contents.
34 2021-05-02 blood clot On April 12, shortly after I got my second Pfizer shot, I started my period. It was very early by se... Read more
On April 12, shortly after I got my second Pfizer shot, I started my period. It was very early by several weeks, and only a week since my previous period ended, which is why I made note of it and have kept a record. For the first week it was fairly light and mostly spotting. After a week, it progressed and became more like a normal period in terms of the amount of blood I was seeing. By April 23rd I started noticing a lot more blood clots in my period than usual--ordinarily I'll see one or two each time I get my period, but there were about five days in a row when I noticed multiple blood clots. The clots stopped around April 28th, but as of today (May 3rd) my period is still ongoing, making it exactly three weeks long, and more unless it suddenly stops today. For the most part the blood has been red and I haven't noticed any other unusual discharge. I have noticed the past few days that the blood is more brown, like old blood. I have not experienced bad cramps or stomach upset during this very long period--I had the same level of menstrual cramping/stomach upset that I am accustomed to over the first couple of days, but nothing since then. I have felt bloated and tired the entire time, however. I have also experienced a really low mood for these few weeks, though I can't be certain if this is worse than I usually experience on my period, because it may just be because it's lasting so long that it feels worse.
34 2021-05-03 blood clot Pt reported painful blue-purple lump on palmar surface of R middle finger at crease of the PIP joint... Read more
Pt reported painful blue-purple lump on palmar surface of R middle finger at crease of the PIP joint, onset 2-3 days after first dose of the Pfizer vaccine, diagnosed by this provider as a palmar digital vein thrombosis. No other precipitating factors such as trauma or exposure to intense vibrations to the finger or other causative factors could be identified. Pt without any history of clotting disorders. Pt healthy, not taking any medications. Pt reported that symptoms were improving at the time of her clinic presentation on 4/13/21. Of note, pt reported her husband, who received the vaccine the same day, had very similar symptoms on the palmar surface of his 5th finger onset a few days after this patient.
34 2021-05-04 brain sinus blood clot Patient received Pfizer vaccine 4/22/2021. She developed severe headaches 48 hours later. She ha... Read more
Patient received Pfizer vaccine 4/22/2021. She developed severe headaches 48 hours later. She has loss of balance and difficulty with fine motor skills. She presented to an ED. Neuroimaging detected significant central venous thrombosis. Admitted to hospital and started on anticoagulation therapy. Neurology and Hematology/Oncology consulted.
34 2021-05-04 blood clot Period lasting over 14 days (still on going). Multiple pads filled in a 2 hour window. A piece of ut... Read more
Period lasting over 14 days (still on going). Multiple pads filled in a 2 hour window. A piece of uterine lining came out of body, approximately 2 inches long and an inch across.
34 2021-05-05 deep vein blood clot Patient presented to her PCP office on 04/20 reporting that on 04/16 she received her 2nd Pfizer vac... Read more
Patient presented to her PCP office on 04/20 reporting that on 04/16 she received her 2nd Pfizer vaccine and the following day on 04/17 she started feeling muscle aches, fatigue and R calf pain from high ankle to the back of knee. On 04/18, all symptoms except the calf pain resolved. She continued to have 1-2/10 calf pain w/o skin changes but mild R > L enlargement of the lower leg. Reported a 3 hour car ride on 04/18 after the calf pain had already started. Denied chest pain, shortness of breath or palpitations. On exam, vital signs stable, right lower leg diffusely tender to palpation and noted to be 4 cm larger in circumference than the left side. Patient was sent for an urgent outpatient duplex ultrasound of her right lower extremity. Ultrasound showed distal DVT in right peroneal veins. She was immediately instructed to discontinue the use of the Nuva ring and started on Xarelto 15 mg BID, with good symptom improvement. Was followed up in clinic on 05/05 with plan to transition to the Xarelto 20 mg QD on 05/13 for a total of 3 months of anticoagulation.
34 2021-05-09 grand mal seizure Grand Mal Tonic-Clonic seizure 3:30 p.m.
34 2021-05-09 vaginal haemorrhage, excessive bleeding positive pregnancy test 1/16/21, vaccine 1/20/21, miscarriage with spotting starting @ 6 weeks pregn... Read more
positive pregnancy test 1/16/21, vaccine 1/20/21, miscarriage with spotting starting @ 6 weeks pregnant on 2/1/21 and additional bleeding 2/2/21-2/7/21.
34 2021-05-09 vaginal haemorrhage Vaginal spotting
34 2021-05-09 vaginal haemorrhage 2 days after 2nd vaccine, vaginal bleeding (period is consistently 30+ days (31,36,30,31) , after va... Read more
2 days after 2nd vaccine, vaginal bleeding (period is consistently 30+ days (31,36,30,31) , after vaccine a 27 days cycle
34 2021-05-14 pneumonia This is a spontaneous report from a contactable consumer (patient) reported for herself. A 34-year-o... Read more
This is a spontaneous report from a contactable consumer (patient) reported for herself. A 34-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 03Apr2021 12:00 at 34 years old (Lot Number: ER8734) as single dose, for covid-19 immunisation. Medical history included Anemia, Depression, Chronic Dry Eye, penicillin allergy. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included cetirizine hydrochloride (ZYRTEC ALLERGY) taken for an unspecified indication, start and stop date were not reported; lifitegrast (XIIDRA) taken for an unspecified indication, start and stop date were not reported; escitalopram oxalate (LEXAPRO) taken for an unspecified indication, start and stop date were not reported. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took pseudoephedrine hydrochloride (SUDAFED) and experienced drug allergy. An hour after the vaccine on 03Apr2021, patient's fingers were red and swollen (like after exercise on a hot day) and she was itchy all over her body. No symptoms for almost 4 days--then she started feeling intermittently dizzy/lightheaded, feverish every night (chills and hot flashes) for the next 4 nights. She got a wracking cough and was short of breath (couldn't climb a single flight of stairs without needing to lie down for several minutes). She was also extremely exhausted-- slept 20 hours in a single day. After multiple telemedicine and in-person appointments, a trip to urgent care, and a chest x-ray and CT, she was diagnosed with pneumonia and treated with antibiotics, vitamin D, and two inhalers. She missed her period, had an elevated d-dimer, and her white blood cell count dropped from 7.0 Thousand u/L to 3.6. She was incapacitated for 2 weeks-- the sickest she had ever been in her life. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient performed Nasal Swab, negative on 11Apr2021. Therapeutic measures were taken for pneumonia. The outcome of the events was recovering.
34 2021-05-18 blood clot Joint pain (particularly leg/knee), inflammation, extremely heavy (and early) period passing blood c... Read more
Joint pain (particularly leg/knee), inflammation, extremely heavy (and early) period passing blood clots. Three weeks (and continuing) for inflammation, two days for period symptoms.
34 2021-05-22 heart attack Myocardial infarction (NSTEMI)
34 2021-05-22 vaginal haemorrhage 3 hours after I received the vaccine I had vaginal spotting. I NEVER, not even once in my life, betw... Read more
3 hours after I received the vaccine I had vaginal spotting. I NEVER, not even once in my life, between periods have experienced spotting. It lasted for a few hours.
34 2021-05-28 deep vein blood clot Blood clots - DVT; This is a spontaneous report from a contactable consumer (patient) reported that ... Read more
Blood clots - DVT; This is a spontaneous report from a contactable consumer (patient) reported that a 34-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0171), via an unspecified route of administration, administered in arm left on 07May2021 08:15 (at the age of 34-years-old) as 2nd dose, single dose for covid-19 immunization. The patient was not pregnant at the time of vaccination. The patient medical history included covid-19 prior vaccination. The patient had no known allergies. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EP8737), via an unspecified route of administration, administered in arm left on 16Apr2021 08:00 AM (at the age of 34-years-old) as 1st dose for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included levonorgestrel (PILL 72) taken for birth control, start and stop date were not reported. On 12May2021, the patient experienced blood clots - DVT. The event resulted in emergency room/department or urgent care. Therapeutic measures were taken as a result of blood clots - DVT as patient received blood thinners. The outcome of the event was not recovered. Since the vaccination, the patient has not been tested for COVID-19.
34 2021-06-09 blood clot I am a woman who has PCOS. My cycle is extremely inconsistent and never last more than a day maybe o... Read more
I am a woman who has PCOS. My cycle is extremely inconsistent and never last more than a day maybe once every year or 2. Two weeks after my 2nd dose of the Covid vaccine I started my menstral cycle , experiencing cramps, discomfort, pressure in my uterus, blood clots daily, and so far it?s been for 8 days. I am not alarmed yet because I understand this might be natural but I am documenting this because it is out of the ordinary in my unique case. I also experienced what seemed like a stomach flu for about 2 days On the 6th and 7th of June. Experiencing diarrhea, nausea, no fever, but heavy fatigue. I no longer feel sick but my period is still active.
34 2021-06-22 excessive bleeding Excessive , uncontrollable bleeding; This is a spontaneous report from a contactable consumer (patie... Read more
Excessive , uncontrollable bleeding; This is a spontaneous report from a contactable consumer (patient). A 35-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, expiration date not provided), 2nd dose via an unspecified route of administration, administered in Arm Left on 16Mar2021 (Lot Number: EW0151) at age of 34 years old as a single dose for covid-19 immunisation. The patient was not pregnancy at time of vaccination. Medical history included anxiety. Concomitant medication included paroxetine hydrochloride (PAXIL). The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided), 1st dose via an unspecified route of administration, date as a single dose for covid-19 immunisation and No reaction on previous exposure to drug. The patient experienced excessive, uncontrollable bleeding on 27May2021 18:15 with outcome of recovering. The patient was hospitalized for the event for 3 days. The patient underwent lab tests and procedures which included Nasal swab: negative on an unknown date. The patient received Blood transfusion and Premarin as treatment for the event. The event was resulted to visit Emergency room/department or urgent care. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient didn't received any other vaccines within 4 weeks prior to the COVID vaccine. Information on the lot/batch was available, further information has been requested.
34 2021-06-22 vaginal haemorrhage Miscarriage: bleeding began May 24, 2021, ultrasound on May 27 showed small development/ only gesta... Read more
Miscarriage: bleeding began May 24, 2021, ultrasound on May 27 showed small development/ only gestational sac and yolk, no fetal pole. Progressively heavier bleeding, mild cramping, expelled tissue. Ultrasound confirmed incomplete miscarriage June 9. Anembryonic pregnancy (blighted ovum). Continued bleeding mod-heavily. Took prescribed misoprostol (3 tablets vaginally) to help complete miscarriage on June 19 (limited effects). Took second dose (4 tablets vaginally) on June 22, limited effects. Continued bleeding until June 23, 2021 (lighter now, the rest is TBD). Est date of delivery: Jan 12, 2022 Second pregnancy (First child born 2017, healthy).
34 2021-06-26 pulmonary embolism Severe cough since April up to now, shortness of breath, Pleural effusion, Bilateral pulmonary embol... Read more
Severe cough since April up to now, shortness of breath, Pleural effusion, Bilateral pulmonary embolism. 3 times hospital admissions. April 26th after the first dose, May 25th after the second dose, and June 16th after confirming the pulmonary embolism. I have not been able to work since April 25 to date.
34 2021-06-29 excessive bleeding, vaginal haemorrhage I learned I was pregnant the day after the first dose of my vaccine. Two and a half weeks after the ... Read more
I learned I was pregnant the day after the first dose of my vaccine. Two and a half weeks after the second dose I experienced bleeding when my pregnancy was at seven weeks. I had spotting for two days. Two weeks after that I had heavier bleeding. I thought my pregnancy was progressing but it was confirmed that the baby stopped growing at seven weeks. I should have been eleven and a half weeks pregnant at that time. Due Date: 01/08/2022 Pregnancy: fourth
34 2021-07-06 cerebral haemorrhage Patient admitted with a significant intaparenchymal bleed in the right fronto-parietal lobe with int... Read more
Patient admitted with a significant intaparenchymal bleed in the right fronto-parietal lobe with intraventricular extension and significant reight-to-left midline shift status post craniotomy and EVD placement.
34 2021-07-07 blood clot Note that these events occurred in another country where I am currently working. Dr. can respond to ... Read more
Note that these events occurred in another country where I am currently working. Dr. can respond to questions about this vaccination. Dr is the specialist who saw me....... after the adverse event to assess possible phsyiological conditions that could have caused the stillbirth and preconception counseling for the future--I only listed her as your form does not allow international numbers, but she can speak to the labs and autopsy and generally on behalf of my obstetrical/gynecological health. I experienced a late-term stillbirth approximately 24 days after the second dose of the pfizer COVID-19 vaccine. I had otherwise not experienced any side effects with either dose of the vaccine. I received my vaccine via the clinic. The stillbirth likely occurred on May 6, but was not confirmed by ultrasound until the morning of May 7. The only sign of the IUFD was cessation of the baby's movements; the event was not accompanied by any pain or bleeding. There was no physical trauma (fall, force to the abdomen, etc). The only event of note between the second dose and the stillbirth was that I went on a four-hour hike Placenta analysis and the fetal autopsy confirmed thrombosis in the placenta's chorionic vessels and a focal increase in syncytial knots, with a diagnosis that placental changes were consistent with fetal vascular malperfusion. The fetus was anatomically normal and appropriate size and weight for gestational age (28 weeks and 6 days per ultrasound). The fetus had no abnormalities or other signs of trauma or infection beyond expected maceration. My ob/gyn and Dr. both opine that the blood clots caused IUFD, with the event being very sudden/acute. There was no explanation identified for what could have caused the sudden blood clots. This was my first pregnancy. I was 29 weeks 0 days along when the IUFD was confirmed, with an estimated due date of July 20, 2021. The pregnancy was unremarkable up until the IUFD. Birth weight was approximately 1230 grams.
34 2021-07-11 systemic inflammatory response syndrome 8 days post vaccine I passed out (vaso vagul syncopy episode) my blood pressure plummeted and I blac... Read more
8 days post vaccine I passed out (vaso vagul syncopy episode) my blood pressure plummeted and I blacked out About 9-10 days post vaccine started getting heart palpitations, racing heart beat, felt like my heart was being squeezed and someone was trying to pull my heart out of my chest. My sternum hurt so bad I felt like I was having a heart attack. 12 days post vaccine I was still feeling very weak and lightheaded all the time and felt like another episode was coming on. I was incredibly nauseous and couldnt get any food down. Lost a few pounds that week because was so nauseous I couldnt eat. Had complete loss of appetite. Was so lightheaded and constantly dizzy when I stood up and tried to walk. Had horrible GI abdominal cramps and had 7 days of yellow diarrhea. Started having tingling in my left hand and fingers and started creeping up. Brain fog. Horrific migraines for 8 days straight. Shivering/chills. Had a hard time with temperature regulation. Could barely walk, couldnt drive, couldnt take care of my toddler. Diagnosed with auto immune disease, Chronic inflammatory response syndrome, SIBO/SIFO, brain inflammation
34 2021-07-13 systemic inflammatory response syndrome February 23 woke up in the middle of the night with sudden left peripheral vision loss. Developed se... Read more
February 23 woke up in the middle of the night with sudden left peripheral vision loss. Developed severe eye pain and light sensitivity, pain with eye movement one week later. Saw ophthalmology, referred to neuroopthamology. Has increased eye pressure in left eye and brimodine drops started. Having scotoma-like vision changes in left eye along with intermittent eye pain and jaw pain. Pain and vision changed lasted 3.5 months before resolving. Eye pressure elevation resolved. Also saw retina specialist and PCP. Had MRI, CTA, US all performed to find underlying cause. No cause was found. Assumption is inflammatory response of some sort, cannot explain Visio loss, vision change, eye a s jaw pin, and increased eye pressure.
34 2021-07-27 vaginal haemorrhage very unusual, heavy vaginal bleeding that lasted through the day, overnight, and into sunday morning... Read more
very unusual, heavy vaginal bleeding that lasted through the day, overnight, and into sunday morning; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 34-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection; Batch/Lot Number: EW0175), via an unspecified route of administration, administered in right arm on 23Apr2021 at 17:00 (at the age of 34-year-old) as dose 2, single for COVID-19 immunization.The patient medical history was not reported. The patient had no allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included sertraline hydrochloride (ZOLOFT), estradiol (VIVELLE-DOT), guaifenesin and ibuprofen. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; Batch/Lot Number: ER8730), via an unspecified route of administration, administered in right arm on 26Mar2021 at 12:30 as first dose for COVID-19 immunization. The patient experienced very unusual, heavy vaginal bleeding that lasted through the day, overnight, and into Sunday morning on 24Apr2021 at 09:00. Since the vaccination, the patient had not been tested for COVID. The patient visited to emergency room/department or urgent care. The patient did not receive any treatment as a result of event. The outcome of the event was resolving. No follow-up attempts are needed. No further information is expected.
35 2021-01-04 vaginal haemorrhage after receiving the vaccine, she started bleeding heavily and is still currently bleeding; This is a... Read more
after receiving the vaccine, she started bleeding heavily and is still currently bleeding; This is a spontaneous report from a contactable consumer (patient). A 35-year-old female received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) with unknown lot number and expiration date, via an unspecified route of administration on 22Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient, a dispatch operator for a hospital, reported that she received the COVID vaccine a week ago on 22Dec2020. She stated that her period stopped two days prior to receiving the COVID vaccine. On 22Dec2020, after receiving the vaccine, she started bleeding heavily and is still currently bleeding. The patient wanted to know what she should do to stop the bleeding. The clinical outcome of the event was not recovered. Information on the lot/batch number has been requested.
35 2021-01-15 vaginal haemorrhage I was 5 weeks pregnant when I got my first dose of the Pfizer covid-19 vaccine. I miscarried 4 days... Read more
I was 5 weeks pregnant when I got my first dose of the Pfizer covid-19 vaccine. I miscarried 4 days later. I do not know if the vaccine contributed to my miscarriage but wanted to contribute to the existing data. I had no other side effects or symptoms other than soreness at the injection site. There were no complications with the miscarriage.
35 2021-01-25 pulmonary embolism PRESENTING PROBLEM: Bilateral pulmonary embolism (HCC) HOSPITAL COURSE: 35-year-old female came in ... Read more
PRESENTING PROBLEM: Bilateral pulmonary embolism (HCC) HOSPITAL COURSE: 35-year-old female came in with shortness of breath and pleuritic chest pain who was found to have bilateral pulmonary embolism with moderately extensive clot burden. Her BNP and troponins were normal and no signs of right ventricular dysfunction on CT scan. Patient was placed on heparin drip and her symptoms improved. Ultrasound Doppler of bilateral lower extremities were negative. This was an unprovoked PE. Patient was switched to and discharged with Xarelto. She will benefit from a hypercoagulable workup once she is off of anticoagulation. After vaccine: patient reported difficulty breathing and fast heartrate
35 2021-01-26 vaginal haemorrhage body aches, chills, fatigue, and generalized headache vaginal bleeding that started 01/27/2021 (have... Read more
body aches, chills, fatigue, and generalized headache vaginal bleeding that started 01/27/2021 (have a Mirena and have not had menstrual bleeding in 3 + years)
35 2021-02-04 anaphylactic reaction Began shaking and face tingling 6 minutes after shot, started to feel slightly better. 10 minutes ... Read more
Began shaking and face tingling 6 minutes after shot, started to feel slightly better. 10 minutes after shot, neck became red, red welts appeared on bilateral upper arms. took 25mg of po benadryl at my desk. 25 minutes after shot felt hot, dizzy, arms and legs tingling, breathless, limbs went numb, rushed to ER via wheelchair. Treated in er for anaphylaxis. Arms and legs felt covered in "icy hot," tachycardia for several hours, numerous times felt impending doom. hospitalized overnight on cardiac monitor. ER gave steroids, benadryl, pepcid, 2L ivf. ativan given later in evening for nervousness.
35 2021-02-24 cerebrovascular accident Developed Bell's Palsy - started on 2/21/21 w/ ear pain and stiff neck, progressed to numbness and t... Read more
Developed Bell's Palsy - started on 2/21/21 w/ ear pain and stiff neck, progressed to numbness and tingling in face and lips on 2/22/21, then hearing loss and left sided facial paralysis. Went to ED, r/o stroke, neck/facial trauma. Given course of prednisone and acyclovir. No improvement noted to date.
35 2021-02-25 vaginal haemorrhage After my second vaccine, I experienced worsening low back pain and bilateral pelvic pain. I tested p... Read more
After my second vaccine, I experienced worsening low back pain and bilateral pelvic pain. I tested positive for pregnancy. I followed up with my gynecologist due to my vaginal bleeding and worsening low back pain.
35 2021-02-26 grand mal seizure ??I had a SEIZURE?? -only symptoms I had right before it happened were: 1-headache and 2-Dizziness ... Read more
??I had a SEIZURE?? -only symptoms I had right before it happened were: 1-headache and 2-Dizziness -lasted almost 4 minutes, it was tonic clinic -911 was called and I went by ambulance to ER
35 2021-03-03 blood clot The following day, she complained of headache, fatigue, dizziness, and lightheadedness for 3 days. O... Read more
The following day, she complained of headache, fatigue, dizziness, and lightheadedness for 3 days. On 2/19/2021 she experienced hives on her abdomen and back that were itchy. No medicine was taken. On the 2/20/2021, she complained of further headache, fatigue, dizziness. She also had shortness of breath. The next day, she presented to the urgent care. She was given an intravenous fluid bolus for dehydration. She was given a "migraine cocktail." She was told that her D-dimer was positive. She had a CT scan that showed sinusitis and her chest was clear. The following day, she complained of progressively worsened ascending pain in her left arm. She had red patches of a rash in her left arm as well. One week later, she went back to the urgent care. An ultrasound was performed and a blood clot was found at. She is now taking Eliquis daily.
35 2021-03-04 anaphylactic reaction This is a 35 yo female who received her 1st dose Pfizer on 1/22/21. Within 5-10 minutes of administ... Read more
This is a 35 yo female who received her 1st dose Pfizer on 1/22/21. Within 5-10 minutes of administration, the patient developed shortness of breath, chest tightness, lightheadedness, altered mental status, and EMS reported a brief syncopal episode. Patient was transported to ED. On presentation to ED, BP=116/71, HR=96, RR=14, SpO2=95%. No rash or swelling noted. The patient did report nausea without vomiting. All labs and EKG normal. The patient was treated (by EMS and ED) with Epi-pen x 2 doses, dexamethasone, duoneb, benadryl, famotidine, ondansetron, and IV fluids. The patient's symptoms improved and she was discharged to home. Final diagnosis = anaphylaxis.
35 2021-03-08 cerebrovascular accident Patient had 4 mm left frontal lobe stroke without any other known etiology on testing (heme, cardio,... Read more
Patient had 4 mm left frontal lobe stroke without any other known etiology on testing (heme, cardio, neuro consulting/workup); This is a spontaneous report from a contactable physician. A 35-year-old female patient (no pregnancy) received the first dose of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine, lot number: EL9267), intramuscularly at site of left arm at 16:30 on 16Feb2021 at single dose for COVID-19 immunisation. Medical history included hypothyroidism and autism spectrum disorder (ASD) (closed 12 years ago with NO sequelae). Concomitant medication included levothyroxine and valacyclovir [valaciclovir], both received within two weeks of vaccine. The patient had 4 mm left frontal lobe stroke without any other known etiology on testing (heme, cardio, neuro consulting/workup) at 13:15 on 20Feb2021. The patient was hospitalized for this event for 2 days. The adverse event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event), disability or permanent damage. The patient received treatment (Multiple MRI/MRI, TTE AND TEE, blood studies/holter study, new medicatinos) for adverse event. No covid prior vaccination. Covid was tested post vaccination. Covid test type post vaccination was blood test, covid test name post vaccination was Ig M/IgG with negative result on 24Feb2021. Covid test type post vaccination was Nasal Swab, covid test name post vaccination was Rapid with negative result on 24Feb2021. No known allergies. No other vaccine received in four weeks. The outcome of event was recovered/resolved with sequel.; Sender's Comments: Limited information does not allow a medically meaningful assessment for the event Stroke for BNT162B2. Details regarding the clinical symptoms, relevant test results, treatment medications and clinical course are not provided. At this time, the case is handled as related for reporting purposes. The case will be re-evaluated if more information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
35 2021-03-15 death She received the 2nd Dose on 3/9/2021. On 3/10/2021 She complained of a headache. On the morning o... Read more
She received the 2nd Dose on 3/9/2021. On 3/10/2021 She complained of a headache. On the morning of 3/11/2021 she complained of abdominal pain and had no appetite. We then found her unresponsive, called 911 and the medics pronounced her at around 1300.
35 2021-03-19 anaphylactic reaction Patient received ?rst in series covid vaccine at approximately 915... she breastfed her 12 month-old... Read more
Patient received ?rst in series covid vaccine at approximately 915... she breastfed her 12 month-old infant shortly thereafter without problem. around 1215 baby was getting fussy and breastfed for about 5 minutes before baby broke out in hives. EMS was called and epinephrine/diphenhydramine administered for course cough/wheezing, presumably anaphylaxis. Other foods consumed by baby on same day included banana, kids ?g newton bar, dried apples, meat from frozen meal, and two piece of cereal (new to baby). ER course required 4 hours of monitoring but no other medical interventions.
35 2021-03-23 vaginal haemorrhage I started bleeding vaginally and having cramping on Tuesday morning. I got my 2nd COVID-19 vaccine o... Read more
I started bleeding vaginally and having cramping on Tuesday morning. I got my 2nd COVID-19 vaccine on Monday morning. I was 5 weeks 5 days pregnant when I started bleeding. I was diagnosed with subchorionic hematoma in the ER. I also experienced bleeding on Thursday and Friday of that week.
35 2021-04-01 pulmonary embolism 1/19/21 - received vaccine around 6:45 pm 1/20/21 - woke up noticing shortness of breath with minima... Read more
1/19/21 - received vaccine around 6:45 pm 1/20/21 - woke up noticing shortness of breath with minimal activity. Monitored, but symptom progressed throughout the day 1/21/21 - woke up with extreme fatigue and more shortness of breath. Unable to walk at all without gasping. Self-monitored with home pulse ox. O2 down in mid 80s and pulse up to 150 with minimal activity 1/22/21 - woke up with worse shortness of breath symptoms. Had husband drive me to the ER and was admitted for 4 days with bilateral moderate to extensive pulmonary emboli
35 2021-04-01 vaginal haemorrhage severe migraine (sometimes causing rainbows in my peripherals), fatigue, chills, occasional fever, s... Read more
severe migraine (sometimes causing rainbows in my peripherals), fatigue, chills, occasional fever, sun sensitivity (bad sunburn in only minimal sun exposure that isn?t healing), my skin keeps turning splotchy with burning and itching sensations and blistering (my face, hands and feet mostly), high blood pressure, bruising easily, dizziness, memory loss, swelling, body aches, muscle cramps in places i didn?t know I could have them, vaginal bleeding for 2 weeks after, nausea, vomiting, stomach cramps. I?m sure I?m forgetting some stuff. They keep just saying it?s a multi system immune response. I had my second shot on 3/5 and haven?t had relief since.
35 2021-04-02 blood clot Bloody nose, headache (same as first vaccine). My menstrual cycle started a week early (I?ve been ob... Read more
Bloody nose, headache (same as first vaccine). My menstrual cycle started a week early (I?ve been obsessively charting for fertility reasons? I am like clockwork) and was full of large blood clots and painful.
35 2021-04-05 heart attack Numbness, tingling, HA, body aches, shingles vesicles next day
35 2021-04-13 brain sinus blood clot Within one month after the first vaccination (2/8/21) migraine intensity increased significantly. Se... Read more
Within one month after the first vaccination (2/8/21) migraine intensity increased significantly. Second vaccine was on 3/22/21. Migraine became so unbearable that I was admitted to ED on 3/25/21.
35 2021-04-16 deep vein blood clot DVT (blood clot) in right leg below knee; leg cramps with sharp pain in calf with pressure, dull pai... Read more
DVT (blood clot) in right leg below knee; leg cramps with sharp pain in calf with pressure, dull pain throughout leg and up to arm and shoulder when seated or laying down; prescribed blood thinners and scheduled follow up with primary care on Monday.
35 2021-04-17 excessive bleeding 3/18 vaccination 3/21 bleeding 3/22 Ultra sound with low fetal HR. 3/22-/3/23 passing of gestationa... Read more
3/18 vaccination 3/21 bleeding 3/22 Ultra sound with low fetal HR. 3/22-/3/23 passing of gestational sac I went back Wed and had another lab work done to compare the levels from Monday to Wed. No other lab work done. 2nd pregnancy, 1 live birth, DOD 11/5/2021
35 2021-04-18 pulmonary embolism, deep vein blood clot Patient developed deep vein thrombus 20 days after vaccine. No significant past medical history. N... Read more
Patient developed deep vein thrombus 20 days after vaccine. No significant past medical history. No significant family history. Patient received her vaccine on March 9. On the weekend of March 27 patient traveled approximately 5 hours by car. Over the course of 2 days after traveling she developed left lower extremity swelling and discomfort. Upon returning home she went to the emergency department and was diagnosed with a deep vein thrombus. Subsequently developed pulmonary emboli.
35 2021-04-19 vaginal haemorrhage I received my second vaccine dose on Friday, 4/16. At the time I was 6 weeks and 4 days pregnant. I ... Read more
I received my second vaccine dose on Friday, 4/16. At the time I was 6 weeks and 4 days pregnant. I woke up at three o'clock in the morning on Saturday, 4/17 sweating with chills, body aches and a headache. When I went to the bathroom at six o'clock AM I noticed that I was bleeding. I called my doctor and she told me to monitor the bleeding over the weekend and to call first thing Monday morning for an ultrasound. I continued bleeding throughout the weekend and yesterday (4/19) my doctor confirmed that I was experience a miscarriage.
35 2021-04-20 deep vein blood clot, blood clot left arm swelling started from 4/18, extended from upper arm to lower arm in the afternoon. went to ... Read more
left arm swelling started from 4/18, extended from upper arm to lower arm in the afternoon. went to Urgent care on 4/19 morning, the NP reviewed my blood report and referred me to do ultrasound and also ask me to go to ER if the swell extend. as the swell extend, i went to ER in the afternoon. blood test shows high D-dimer and then ultrasound finds blood clot in the vessel near left neck. diagonised to be Deep Vein Thrombosis. no family history of such problem. in the hospital, they gave me a shot of blood thinner and also prescript oral blood thinner to be take at home.
35 2021-04-24 vaginal haemorrhage Abdominal cramps, with vaginal bleeding
35 2021-04-26 blood clot Acute non occlusive thrombus of common femoral and iliac vein in left leg
35 2021-04-27 blood clot 4 days later minor blood clot in my finger (not sure it is drug related); Bruise at site of injectio... Read more
4 days later minor blood clot in my finger (not sure it is drug related); Bruise at site of injection; This is a spontaneous report from a non-contactable consumer (patient). A 35-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 09Apr2021 (Batch/Lot number was not reported) as SINGLE DOSE for COVID-19 immunization. Medical history and concomitant medications were not reported. On 13Apr2021, the patient had bruise at site of injection and 4 days later (17Apr2021) minor blood clot in her finger was noted (not sure it was drug related). The patient had no COVID-19 prior vaccination and not tested post vaccination. The patient requires doctor or other healthcare professional office/clinic visit for the events and unknown if treatment was received. The patient had not yet recovered from the events. No follow up attempts are possible. information about lot/batch number cannot be obtained
35 2021-04-28 grand mal seizure FOLLOWING PATIENTS FIRST PFIZER COVID -19 INJECTION, PATIENT PASSED OUT, BECAME UNRESPONSIVE AND CYA... Read more
FOLLOWING PATIENTS FIRST PFIZER COVID -19 INJECTION, PATIENT PASSED OUT, BECAME UNRESPONSIVE AND CYANOTIC IN THE LIPS AND THAN HAD A TONIC CLONIC SEIZURE FOR 45 SECONDS. PATIENT WAS TAKEN TO ER BY EMS WITH HER HUSBAND.
35 2021-04-28 blood clot Caller states she was not due for her monthly menstrual period for another week, so she found, passi... Read more
Caller states she was not due for her monthly menstrual period for another week, so she found, passing the clot, odd.; Blot clot/Very big blood clot, that passed out of body; Fever, of 102; Sore arm; This is a spontaneous report from a contactable Other HCP (patient). A 35-years-old female patient (no pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 29Mar2021 09:00 (Lot Number: ER2613) as single dose for covid-19 immunisation. Medical history included ongoing asthma , contraception. Concomitant medication included ethinylestradiol, norgestimate (SPRINTEC) taken for contraception from an unspecified start date and ongoing. The patient previously took bactrim and experienced drug hypersensitivity. The blood clot only was for one day on 31Mar2021, and it was one blood clot. The patient went to the bathroom and it was passed, one time. The patient was not due for her monthly menstrual period for another week, so she found, passing the clot, odd. The patient menstrual period did happen on time and it was normal. The patient was not due for her menstrual period for another week, and she takes birth control. The patient contacted her Gynocologist, and it was confirmed that she was not pregnant, and states her menstrual period happened on time. The clot did not happen again. The patient had Fever, of 102 on 30Mar2021, the temperature resolved in a day. The patient took Aleve, drank a lot of water and napped, reclarifies, and the temperature improved. The patient experienced sore arm on 30Mar2021. The outcome of event Clot blood was recovered on 31Mar2021; outcome of event Fever was recovered on 30Mar2021; outcome of event Sore arm was recovered on 01Apr2021, outcome of other event was unknown. No other vaccine in four weeks; No covid prior vaccination; No covid tested post vaccination.; Sender's Comments: Based on the temporal relationship, A possible contributory role of the suspect product to the development of Thrombosis and Menstrual Disorder cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
35 2021-04-28 blood clot Heavy menstrual cycle came the day I got the Covid vaccine, despite not having period while on IUD f... Read more
Heavy menstrual cycle came the day I got the Covid vaccine, despite not having period while on IUD for many months before this. Clotting in period, cramping.
35 2021-04-29 blood clot Blood clot in right leg.
35 2021-05-02 heart attack, blood clot PT PRESENTED TO ER WITH COMPLAINTS OF CHEST PAIN. REPORTED RECEIVING COVID VACCINE 5 AND 2 EEKS PRIO... Read more
PT PRESENTED TO ER WITH COMPLAINTS OF CHEST PAIN. REPORTED RECEIVING COVID VACCINE 5 AND 2 EEKS PRIOR. IT WAS NOTED SHE HAD ELEVATED TROPONIN LEVELS, NSTEMI. PT TRANSFERRED TO ANOTHER MEDICAL CENTER FOR HIGHER LEVEL OF CARE/CARDIOLOGY. HEART CHAT PERFORMED. THE DISTAL ONE FOURTH OF THE LAD WAS OCCLUDED AND APPEARED TO BE FROM THROMBUS. OTHER FINDINGS ALSO NOTED . PT DID NOT REPORT PRIOR HISTORY OF CORONAY HEART DISEASE OR MI.
35 2021-05-03 vaginal haemorrhage On April 9th received 1st dose of vaccine, approx. 12 hours later experienced bright red spotting, c... Read more
On April 9th received 1st dose of vaccine, approx. 12 hours later experienced bright red spotting, called MD and was seen and fetal heart tone was present on April 12th. Received 2nd dose of vaccine on May 1st and and approx. 12 hours later started to have bright red vaginal bleeding which then turned into spotting. On May 3rd at 1130pm started to have bright red bleeding and water broke. Came to the emergency room for evaluation where I was told I had lost the baby, no fetal heart tone present. I am experiencing a miscarriage @ 15 weeks gestation and 6 days today on May 4th 2021.
35 2021-05-07 pulmonary embolism Pulmonary embolism; Is pregnant: yes; This is a spontaneous report from a contactable healthcare pro... Read more
Pulmonary embolism; Is pregnant: yes; This is a spontaneous report from a contactable healthcare professional (patient). A 35-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 27Jan2021 14:00 (Batch/Lot Number: EL3249) and dose 2 via an unspecified route of administration, administered in Arm Left on 17Feb2021 14:00 (Batch/Lot Number: EN6200); both as single dose for covid-19 immunisation. Medical history included pregnancy, allergies to penicillin and Covid prior to vaccination. The patient's concomitant medications were not reported. The patient has no other vaccine in four weeks. The patient experienced pulmonary embolism on 18Apr2021 16:00 which resulted in doctor or other healthcare professional office/clinic visit. CT scan and ultrasound were done, and patient was given lovenox injections. The patient is pregnant with last menstrual cycle on 20Jan2021; delivery date will be on 05Nov2021. The patient was not tested for Covid post vaccination. The outcome of the event pulmonary embolism was not recovered.; Sender's Comments: A causal association between BNT162B2 and the reported event Pulmonary embolism cannot be excluded based on a compatible temporal relation. The contribution of pregnancy to thromboembolic events should also be considered. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
35 2021-05-10 heart attack difficulty breathing; racing heart; Dizzy; nauseated; headache; heart attack; fingers started tingli... Read more
difficulty breathing; racing heart; Dizzy; nauseated; headache; heart attack; fingers started tingling and going numb; fingers started tingling and going numb; arms became heavy; lethargic; feeling exhausted; Arms are still weak; This is a spontaneous report from a contactable consumer (patient). A 35-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), at same age, via an unspecified route of administration, administered in arm left on 23Apr2021 09:00 (Batch/Lot Number: EW0169) as single dose for covid-19 immunisation. Medical history included scoliosis. The patient's concomitant medications were not reported. Patient was received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: CR8733), at age of 35 years old, administered in arm left on 02Apr2021 05:00 PM, for covid-19 immunisation. The patient experienced dizzy and nauseated with a headache at 3:00am 26Apr2021. At 7:00am patient woke up again with the same symptoms but strong nausea, difficulty breathing and racing heart. Her fingers started tingling and going numb once she was up (on 26Apr2021). Her arms became heavy and she started feeling lethargic (on 26Apr2021). Patient thought she was having a heart attack on 26Apr2021. Blood pressure was normal and pulse ox was normal. Most symptoms subsided by 11:00am. Arms are still weak at 7:47pm. Still feeling exhausted. Events resulted in doctor or other healthcare professional office/clinic visit. No other vaccine administered in four weeks. No other medications in two weeks. No treatment was received. No covid prior vaccination. No covid tested post vaccination. No known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcomes of events were recovering.
35 2021-05-12 cerebrovascular accident that same day I was feeling dizzy and my whole right side of my body went numb and as well the belie... Read more
that same day I was feeling dizzy and my whole right side of my body went numb and as well the believe it was a stroke and they said I had a stroke as well
35 2021-05-13 anaphylactic reaction its kind of scratchy and red in rays its kind of itches; its kind of scratchy and red in rays its ki... Read more
its kind of scratchy and red in rays its kind of itches; its kind of scratchy and red in rays its kind of itches; its kind of scratchy and red in rays its kind of itches; lip swelled up on left side; really tired; Dry mouth; soreness at injection site; still had not had periods/ had not yet started her cycle; anaphylactic reaction; rash so it is on her left armpit kind of going towards her chest; swelling; This is a spontaneous report from a contactable consumer (patient). A 35-year-old female patient (pregnant: No) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8736), via unspecified route of administration in left arm on 24Apr2021 at single dose for COVID-19 immunisation. The relevant medical history included react like that normally is it eat bananas or sweet potato, asthmatic. Concomitant medications included vitamins nos. The patient previously took Wellbutrin, Methocarbamol and both experienced drug allergy. The patient previously received first dose of BNT162B2 (Lot number: ER8735) on 02Apr2021 at the age of 35 years old for COVID-19 immunisation and had menstruation irregular. The patient got her 2nd Vaccine that past Saturday and she got it on her left side of her body and her lip swelled up on left side and then she got a rash but the rash was going away and swelling going down but she thought she needed to report that. The patient still had not had periods which was very unusual for her and she tested the pregnancy test and she was not pregnant. Anatomical site of swelling was stated as left side of her lip on her face it looked like she got stung by a bee and then the swelling had been going down on that, the rash was going away as well. When confirmed the event start date, 25Apr2021 was stated for the swelling and rash. For causality the patient stated that she thought so because she was allergic and she avoided she had not got a rash like that from eating them. She also got like swelled lips or hives and she did not get hives and in this period that was the only thing and she had couple of other friends that had biological symptoms too, so that was the reason she was pretty sure it was connected. The patient stated that the swelling and the rash was still there, the swollen lip was going down and she had not yet started her cycle. She also stated that swelling was improved, rash was better but she could still see it. After her vaccine she was really tired and she was sure a lot of people were so she just fall asleep for 12 hours. When she woke up it was a little better. So she did not take anything specifically for that. When described the signs and symptoms of the anaphylactic reaction, the patient stated that it looked kind of well she mean let her look at the rash so its on her left armpit kind of going towards her chest and its kind of scratchy and red in rays its kind of itches over then but its not writhing or sheathing. She was asleep for 12hrs she thought it came up some time either late Saturday night or early Sunday morning. She didn't had any problem in breathing, she didn't have tightness in her chest no racing heartrate nothing like that. No medical intervention required. No Emergency Department and no hospitalization. The patient got dry mouth but again she didn't like super weird, she didn't had any racing heart rate, she did not had any respiratory symptoms, obviously dermatologically did. She would say as reaction go well significantly minor she had soreness at injection site but she didn't had any raised she wasn't raised can't even tell now for that well that fine. No initiation of new medication or other treatment or procedure required. Her husband was positive back in the fall. She was tested but she quarantined from him and she never got it. She tested 4 times negative. The outcome of the event rash, lip swelling and swelling was recovering, while other events were unknown.
35 2021-05-19 pulmonary embolism 2 days after vaccination (Sunday May 2) I began to feel slightly chest pain when I would breath on t... Read more
2 days after vaccination (Sunday May 2) I began to feel slightly chest pain when I would breath on the upper left chest shooting downward to the bottom breast rib area. Every time I would take a deep breath I would feel the pain. Called loyola hotline to discuss and state worries I had. Pain continued the next day. Went to the loyola urgent care center Monday at about noon. Took EKG test there and everything seemed fine however they did mention my birth control and possible side effects. So they sent me to thenhospotal for more test. Sent me to the ER. From the ER took several test and blood work. Another eck as well as D-dimer test, lots of blood work and a CT scan. Later that night I was told I had a pulmanary embolism (blood clot in my lung) and I needed to stay overnight. They continued to take addt. Exams the next day and.more blood for test. Took a heart echo since pains were happening on my left side. As well as ultrasound on my leg to check for DVT and if more blood clots exist.. Addt. Test done that Tuesday, then was discharged Tuesday at about 5pm.
35 2021-05-20 pulmonary embolism Patient was admitted to the hospital on 05/21/2021 with bilateral pulmonary embolism of unclear etio... Read more
Patient was admitted to the hospital on 05/21/2021 with bilateral pulmonary embolism of unclear etiology. Risk factors for pulmonary embolism included obesity and tobacco abuse. No other risk factors for pulmonary embolism. She received her 1st dose of the phizer COVID-19 vaccination less than 30 days prior to presentation with PE.
35 2021-05-24 pulmonary embolism Shortness of breathe, chest pain, numbness which resulted in pulmonary embolism
35 2021-05-25 pulmonary embolism Pfizer-BioNTech COVID-19 Vaccine EUA: patient presents to emergency department (ED) nauseated with i... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA: patient presents to emergency department (ED) nauseated with intermittent chest pain and shortness of breath starting three days after vaccination. Initially experienced arms discomfort, throat tightness, chills, and numbness in face and chest that resolved. Seen at another ED three days after vaccination for chest pain and discharged. Followed-up by primary care the next day where vitals were stable and exam was not concerning. In current ED patient's vital signs within normal ranges and physical exam unremarkable. Patient diagnosed with pulmonary embolism, prescribed anticoagulants, and on follow-up with primary care provider patient reports no new symptoms and vital signs with within normal ranges.
35 2021-05-27 blood clot I am feeling a clot in my left armpit after 1 day of having 2nd dose of COVID19 Pfizer; This is a s... Read more
I am feeling a clot in my left armpit after 1 day of having 2nd dose of COVID19 Pfizer; This is a spontaneous report from a contactable consumer (patient). A 35-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration and administered in left arm at age of 35-years, on 11May2021 18:00 (Lot Number: EW0179) as single dose for covid-19 immunization. The patient medical history was not reported. The patient was not pregnant at time of vaccination. Concomitant medications were none (the patient did not receive any other medications within 2 weeks of vaccination). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Historical vaccine included the first dose of BNT162B2 on an unknown date for covid-19 immunization. The patient reported that she was feeling a clot in her left armpit at 08:00 on 13May2021 (reported as after 1 day of having 2nd dose of COVID19 Pfizer). The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. Event outcome was not recovered. No follow-up attempts needed. No further information expected.
35 2021-06-01 vaginal haemorrhage Vaginal bleeding started 2 days after shot.. it has been almost two weeks and still bleeding.
35 2021-06-06 vaginal haemorrhage First shot was on 03/29.21, I didn't know but I was already pregnant about 7 weeks. Second shot was... Read more
First shot was on 03/29.21, I didn't know but I was already pregnant about 7 weeks. Second shot was taken on 04/21/21. On 05/11/21 and 05/12/21, I checked in on Emergency Care with craps and light bleeding. A ultrasound and blood tests were done and I was informed I had had a miscarriage. We don't know if it was just a coincidence or if there is any link to the Covid19 vaccine but I was oriented by CDC to report the finding if I would like to.
35 2021-06-07 excessive bleeding This was my pt. Presented with normal first trimester ultrasound giving EDC 9/27/21. Returned with... Read more
This was my pt. Presented with normal first trimester ultrasound giving EDC 9/27/21. Returned with normal 15 week visit with positive fetal heart tones and no complications. Pt states she received her covid vax towards the end of that week (facility unknown, I believe by Pfizer). She presented 3 1/2 weeks later to my clinic with bleeding. Dx intrauterine fetal death that occurred at 16 weeks 2 days by growth on ultrasound (shortly after covid vax). Options below are not appropriate- Fetal death
35 2021-06-07 blood clot and multiple golf ball-sized clots.; Extreme menstrual period; High pain, extremely heavy flow; High... Read more
and multiple golf ball-sized clots.; Extreme menstrual period; High pain, extremely heavy flow; High pain, extremely heavy flow; This is spontaneous report from a contactable consumer (patient). A 35-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration, administered in Arm Right on 07Apr2021 11:15 (Lot Number: ER8734) at the age of 35-year-old, as 2nd dose, single for covid-19 immunisation. Medical history included known allergies Latex and Penicillin. Prior to vaccination, the patient was not diagnosed with COVID-19. Historical vaccine included first dose of bnt162b2 (lot number: EN6206) on 17Mar2021 11:15, administered in right arm, for covid-19 immunisation. The patient's concomitant medications were not reported. The patient had extreme menstrual period (unlike her typical cycle) experienced about 18 days after the second shot. High pain, extremely heavy flow (more than an oz and hour sustained for almost two full days), and multiple golf ball-sized clots. Events occurred on 25Apr2021 07:30. No treatment was taken for adverse event (AE). Since the vaccination, the patient has not been tested for COVID-19. The outcome of events was recovered. No follow-up attempts are possible; information about lot/batch number obtained.
35 2021-06-09 vaginal haemorrhage Vaginal bleeding with clots Leg pain fatigue
35 2021-06-14 vaginal haemorrhage Prior to the vaccination I had a normal pregnancy. This was my first pregnancy. . No issues with me ... Read more
Prior to the vaccination I had a normal pregnancy. This was my first pregnancy. . No issues with me or fetus. I did receive the flu vaccine in the fall of 2020 but no other vaccines or medications than those previously reported. On 4/23/2021 I began experiencing a small amount of bloody discharge which continued for 10 days. I was evaluated in OB triage on 5/5 by exam, blood work and ultrasound. All tests came back normal and the pathology from discharge was blood and mucus. The discharge continued until 2 weeks later on 5/19 when it became brighter red. I was evaluated by OB triage again by exam and blood work with normal results. Cervix showed no signs of labor and I was not dilated. On 5/20 I began leaking amniotic fluid and my water broke. My son was born at 30 weeks and 3 days (due date 7/26/2021). He is in NICU as of this report but doing as well as could be expected.
35 2021-06-18 vaginal haemorrhage I just had my second shot yesterday morning. For the first dose, I didn't have any of the typical si... Read more
I just had my second shot yesterday morning. For the first dose, I didn't have any of the typical side effects other than sore arm. On June 4th, I started having vaginal bleeding. I called the on call triage and the bleeding was significant enough to go to ER. Was there and almost had a DNC at that point because the doctor felt the bleeding was so significant. But there was a wait in ER, had an ultrasound, by that time bleeding slowed down and I went home with the caveat that if the bleeding returned to go to ER again. The doctor's were saying that a miscarriage was going to happen....so we were taking it day by day. 10 days later, I started bleeding again and then I miscarried on Tuesday of this week. I started cramping at 1;:00 in the morning and felt the water break and then started bleeding heavily again at 03:00 in morning. Follow up with OB's on June 7th. And I went to ER and once we got there and they checked the ultrasound and they couldn't see the baby any more and they had me go in to a D&E. Pregnancy - 3rd pregnancy - one live birth (my son); the first pregnancy was an elective abortion; Estimated date of delivery was going to be December 1 (I was 15 weeks)
35 2021-06-23 anaphylactic reaction Anaphylaxis After 5 min - tongue itching After 10 min - anxious feeling, dizziness, tingling After ... Read more
Anaphylaxis After 5 min - tongue itching After 10 min - anxious feeling, dizziness, tingling After 15 min - wheezing, difficulty breathing
35 2021-06-23 vaginal haemorrhage Strong menstrual cramps and bleeding for 4 days. I have had an IUD in place for years and do not get... Read more
Strong menstrual cramps and bleeding for 4 days. I have had an IUD in place for years and do not get a period anymore. This was abnormal for me.
35 2021-06-25 blood clot in the brain, cerebrovascular accident I had a stroke on April 26 after receiving the COVID-19 vaccine in April 23. I had brain surgery to ... Read more
I had a stroke on April 26 after receiving the COVID-19 vaccine in April 23. I had brain surgery to remove a clot. I have to take speech therapy because my speech is affected.
35 2021-06-25 cerebrovascular accident Systemic: Stroke-Severe, Additional Details: Spouse of patient states that wife fell on 6/2/21 and w... Read more
Systemic: Stroke-Severe, Additional Details: Spouse of patient states that wife fell on 6/2/21 and went to the emergency room. States that MD said patient no histoy of blood disorder and believes patient got a stroke due to COVID vaccine. Currently taking blood thinners for incident. Now has trouble speeking due to blood clot/stroke.
35 2021-06-26 blood clot patient symptoms: no strength, hard to breathe, notices blood clots a few inches from injection sit... Read more
patient symptoms: no strength, hard to breathe, notices blood clots a few inches from injection site
35 2021-07-01 anaphylactic reaction itch; Pain; I got the 1st vaccine a dark red spot started to show on the right side of my jaw; The r... Read more
itch; Pain; I got the 1st vaccine a dark red spot started to show on the right side of my jaw; The rash covered the bottom of my face around one eye; my left three fingers are still scabby; During my period that month after the vaccine, I also had very large blood clots. Two of them size of small grapefruit.; everything I used on it made it burn; I couldn't sleep; swelled my face for two weeks, There was a hard knot in my jaw.; Lips felt swollen; anaphylactic reaction; This is a spontaneous report from a contactable consumer (patient herself). A 35-years-old non-pregnant female (not-pregnant at the time of the vaccination) patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EW0150; Expiration date: unknown) via an unspecified route of administration, administered in Arm Left on 07Apr2021 11:00 (at the age of 35-years-old) as first dose single for COVID-19 immunization at Hospital. Medical history included non-compaction cardiomyopathy. Patient had known allergies Sulfur, sulfites, Penicillin, Sea Food, Cortisone, MSG. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included other medications the patient received within 2 weeks of vaccination was Metoprolol Tartrate (METOPROLOL TARTRATE) taken for an unspecified indication. Prior to vaccination the patient was not diagnosed with COVID-19 and Since the vaccination, the patient had not been tested for COVID-19. It was reported that, two days after she got the 1st vaccine, on 09Apr2021 03:00pm a dark red spot started to show on the right side of her jaw. That soon started to itch. It swelled her face for two weeks. There was a hard knot in her jaw. She treated it like poison ivy but everything she used on it made it burn. The only thing that helped the itch and pain was Benadryl every four hours or she could not sleep this lasted for two weeks. The rash covered the bottom of her face around one eye. Down both arms and left side of her breast down the stomach. This rash also blustered on hand and other parts of her arm. It finally started really go away after three weeks. It had been four weeks and could see her left three fingers were still scabby. During her period that month after the vaccine, she also had very large blood clots. Two of them size of small grapefruit. On 09Apr2021 at 15:00, The patient got the 1st vaccine a dark red spot started to show on the right side of my jaw itch, Generalised rash began Right antecubital with itching red patch then spread to chest back neck extremities lips felt swollen. The symptoms occurred after 2 days after administration of vaccination. The reporter described all the signs and symptoms of the anaphylactic reaction: Generalised rash began Right antecubital with itching red patch then spread to chest back neck extremities lips felt swollen, anaphylactic reaction occurred 2 days after immunization administration. Patient visited Doctor or other healthcare professional office/clinic visit due to AE resulted. The Multi organ involvement included Lips felt swollen, Dermatological/ Mucosal, Generalized Pruritis with skin rash, included began Right antecubital with itching /ed patch then spread to chest back neck extremities. The patient was not hospitalised. Therapeutic measures were taken for adverse events which included cetirizine 10mg, famotidine 20mg and diphenhydramine 25mg, antihistamine. The outcome of the events were resolved on an unspecified date in 2021. The reporter stated that the reported adverse event(s) with the use of the product. The Pfizer product had a casual effect to the adverse event. Information about batch/ lot number has been requested. Follow-up(17Jun2021)This is a follow up spontaneous report from a contactable other HCP. This other HCP reported in response to DCA letter sent via Follow up letter which included that: suspect details (Lot number, route of administration, anatomical location), Event information, Treatment, concomitant medication, causality were added and updated.
35 2021-07-06 sepsis Severe sharp pain in abdomen, diarrhea, nausea; lasted 48 hours before being transported to hospital... Read more
Severe sharp pain in abdomen, diarrhea, nausea; lasted 48 hours before being transported to hospital via ambulance due to severity of pain
35 2021-07-11 blood clot Extremely heavy menstrual cycle with large clots.
35 2021-07-11 vaginal haemorrhage Heavy vaginal bleeding for 2 weeks; Severe migraine that wont go away; Diarrhea; chills; fever; High... Read more
Heavy vaginal bleeding for 2 weeks; Severe migraine that wont go away; Diarrhea; chills; fever; High blood pressure; Hands randomly turn red and burn; Hands randomly turn red and burn; phlegm; headache; body aches; nausea; sun sensitivity and sunburn last 2 weeks; sun sensitivity and sunburn last 2 weeks; This is a spontaneous report from a contactable other Health Care Professional. A 35-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6199 and Expiry date: Unknown)via an unspecified route of administration, administered in left Arm on 05Mar2021 at 10:45 as Dose 2,Single for COVID-19 immunization. The patient's medical history included endometriosis, Allergies to medications, food, or other products PNC, tetracycline, and methlyparaben. Patient took first dose of bnt162b2 (-PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6201 was not reported) on 12-FEB-2021 for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and on 18Mar2021has been tested for COVID-19 resulted in Negative.On 05Mar2021 the patient experienced heavy vaginal bleeding for 2 weeks, severe migraine that wont go away, diarrhea, chills, fever, high blood pressure, hands randomly turn red and burn, phlegm, sun sensitivity and sunburn last 2 weeks, nausea, body aches, headache. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 18Mar2021.Therapeutic measures were taken as a result of the adverse events. Patient's treatment for the adverse event included Headache cocktail, imitrex, steroids, zofran, bent. On Mar2021 the outcome of events Heavy vaginal bleeding for 2 weeks, nausea, body aches, was recovered while the outcome of events Severe migraine that wont go away , Diarrhea , chills , fever , High blood pressure , Hands randomly turn red and burn,phlegm ,sun sensitivity and sunburn last 2 weeks,headache was not recovered .; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events Vaginal hemorrhage, Migraine, Diarrhea, Chills, Pyrexia, Blood pressure increased, Erythema, Burning sensation, Productive cough, Photo sensitivity, Sunburn and Headache and suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
35 2021-07-14 pneumonia, death Pt. started coughing Tuesday, June 22, 2021, in the afternoon and it worsened through the rest of da... Read more
Pt. started coughing Tuesday, June 22, 2021, in the afternoon and it worsened through the rest of day. She also was beginning to be drowsy. Wednesday, June 23, 2021, coughing continued, she became drowsier, she felt warm to the touch (forehead, face, arms, back) and was not acting like herself. Thursday, June 24, 2021, 9am she was at the clinic. The doctor ordered an x-ray and blood work. After results arrived, we were advised to go to the emergency room. There the doctor ordered CT scan. The results showed an abscess and fluid in her left lung and pneumonia. Her lung was drained, was not able to get all of it out. They discussed surgery but needed to send pt. to ER. The discussion for surgery was a daily thing but never happened. They tried multiple procedures, CT scans, etc. On Tuesday, June 29, 2021 there was a meeting called with her doctor to discuss palliative care. The risk of surgery and all the complications following were high risk. Pt. did not understand that she needed to leave the IV and drainage tube in as well as leaving the oxygen on. Based on the complications and pts. quality of life after surgery and the fact that the fluid and pneumonia spread quickly throughout her body - the doctors were leaning towards end-of-life comfort. It all happened so fast! The evening of the 29th, pt. was transported home to end her life on hospice. On Wednesday, June 30, 2021 pt. passed away in the afternoon. Pt. was rarely ever sick. Once in a great while she would get a runny nose or little cough. Everyone around her would catch a virus and she simply would not. We had a member of our family test positive for COVID-19 in November 2020, and pt. never showed any symptoms of being ill. This was all before she received the COVID-19 Vaccine. About a week or two after she received the second vaccine, on May 27,2021. she had increased behaviors with eating and daily ADLs. But the behaviors were her ?normal? behaviors that would occasionally come and go. Nothing was ever persistent. Then on Tuesday June 22, 2021 when sick like symptoms started to appear it was less then four weeks after the second vaccine.
35 2021-07-14 blood clot Adverse menstrual issues: - First period after vaccine EXTREMELY painful. Pain NOT like period cram... Read more
Adverse menstrual issues: - First period after vaccine EXTREMELY painful. Pain NOT like period cramps, instead was similar to pain I have experienced after previous uterine surgeries (ie. feeling severely inflamed). Period was heavier + lasted 2 days longer than usual. - Second + third periods after vaccine painful again. Much less so than the prior month, but still much more pain than I usually feel. Pain seems to radiate from lower back + lower abdomen. Period slightly heavier still. - Third period after vaccine I passed a large stringy blood clot. I have never done this before. - Experiencing increase in endometriosis pain. Usually pain is quite sporadic + only occurs 10 times a year . Now experiencing pain weekly or biweekly. NB. I have Asherman?s Syndrome. Due to this I haven?t experienced any period pain for 6yrs + my periods have been extremely light. This has been well documented with my Obgyn + Reproductive Endocrinologist. Therefore I can conclusively identify the vaccine as signaling these changes to my menstrual cycle.
35 2021-07-18 vaginal haemorrhage After the second vaccine, I felt arm soreness, muscle aches, around the 30th I started cramping when... Read more
After the second vaccine, I felt arm soreness, muscle aches, around the 30th I started cramping when i was out on a walk during the heat wave, I had some loose bowels, i went to ER on the 2nd I started bleeding. They did a bunch of blood work and an ultrasound, they said the baby was about 8 weeks along, It looks like the baby stopped developing around 6 weeks, My HCG levels started dropping, on my follow up I lost baby, I was bleeding and having discharge until about July 11.
35 2021-07-27 vaginal haemorrhage cramping with a lot of pain; I was spot bleeding; By April 24th I was cramping with a lot of pain an... Read more
cramping with a lot of pain; I was spot bleeding; By April 24th I was cramping with a lot of pain and bleeding.; I was supposed to start my period April 27/28; nauseous; This is a spontaneous report from a contactable consumer (patient). A 35-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: ew0161), dose 1 via an unspecified route of admin-istration, administered in Arm Left on 16Apr2021 at 15:15 (at the age of 35-years-old) as single dose for covid-19 immunisation. Medical history included none. Concomitant medication included semaglutide (OZEMPIC), ethinylestradiol, norethisterone acetate (AUROVELA 1.5/30) taken for unspecified indication from unknown date. The patient previously took amoxicillin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 17Apr2021 at 17:00 (in less than 24 hours after receiving the vaccine), the patient was started with the event of spot bleeding, by april 24th, was cramping with a lot of pain and bleeding, She reported that she does not usually have painful cramps and have been randomly nauseous since getting her vaccine shot. she was supposed to start her period april 27/28. Facility where the most recent COVID-19 vaccine was administered was a pharmacy or Drug Store. All the seriousness criteria was reported as ‘no'. It was unknown if prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Device date was provided as 28Apr2021. Outcome of the events were unknown. Information about Lot/Batch number was available. Additional information has been requested.
36 2021-01-04 low blood platelet count starting to feel lethargic and weak. Had menses with increased blessed. Called physician to have b... Read more
starting to feel lethargic and weak. Had menses with increased blessed. Called physician to have blood work done to see if I was experiencing anemia. Blood work complete on 12/31/2020. On 1/3/2021, I woke up with blood blisters all over the inside of my mouth and petechia on my trunk and bilateral upper and lower extremities. I called my primary physician to report the symptoms. He suggested to go to the ER if my symptoms worsened. Later that evening I started with a nose bleed and did go to the ER. Upon arrival to the ER, my platelet count was 9. I was admitted to the hospital and diagnosed with ITP.
36 2021-01-05 pneumonia The day after the vaccine I had fatigue and body aches. Then on 12-23 fevers of 101.4, chills, body ... Read more
The day after the vaccine I had fatigue and body aches. Then on 12-23 fevers of 101.4, chills, body aches, diarrhea, vomiting, productive cough, and profuse sweating. Jan 1st I was in the shower and was dizzy with a headache. Loss of consciousness almost happened and that is when i got out of the shower and laid down. Went to the ED and was diagnosed with bilateral pneumonia
36 2021-01-10 vaginal haemorrhage mild vaginal bleeding. started the day after vaccine #1. appeared to be a light period though unusu... Read more
mild vaginal bleeding. started the day after vaccine #1. appeared to be a light period though unusual since I have mirena IUD. Resolved after 3 days. no medical care was required. no other signs of bleeding/bruising.
36 2021-01-13 cardiac arrest Approximately 12 hours after receiving the booster dose, she awoke feeling extremely ill and nauseou... Read more
Approximately 12 hours after receiving the booster dose, she awoke feeling extremely ill and nauseous, roused me to say so, and then immediately became unresponsive and pulseless. She was admitted to hospital for cardiac work up, and all diagnostic tests have found her heart to be normal in structure and function. Cardiology believes she experienced a vasovagal syncope with asystole. She remains hospitalized at this time for initiation of sotalol therapy; she was diagnosed with frequent PVCs approximately 1 year ago.
36 2021-01-13 ischaemic stroke Vaccinated Thursday morning, later in the evening felt achy and had a fever. Headache for 2 days. Sa... Read more
Vaccinated Thursday morning, later in the evening felt achy and had a fever. Headache for 2 days. Sat morning 1/9/21 woke up with left arm weakness and numbness which went up to her face. Had an MRI completed which showed a new small right paritial ischemic stroke.
36 2021-01-15 excessive bleeding 9 days after vaccine, I had a miscarriage. I was 5 weeks pregnant at that time. I had confirmation l... Read more
9 days after vaccine, I had a miscarriage. I was 5 weeks pregnant at that time. I had confirmation lab test 2 weeks prior of pregnancy and had labs with bhcg lower at time of bleeding to confirm miscarriage
36 2021-01-17 anaphylactic reaction 1 hour post injection patient returned with redness and borderline hives in her left arm, chest, nec... Read more
1 hour post injection patient returned with redness and borderline hives in her left arm, chest, neck and face. She complained of feeling very hot and with mental confusion. We administered 50 mg of diphenhydramine, and 15 minutes later sent her to the ED. At the ED they diagnosed her with a minor anaphylaxis reaction, gave her methylprednisolone and epinephrine.
36 2021-01-18 anaphylactic reaction Anaphylactic
36 2021-01-19 anaphylactic reaction Systemic: Anaphylaxis-Severe
36 2021-01-24 cardiac arrest Vasovagal syncope with asystole; Vasovagal syncope with asystole; This is a spontaneous report from ... Read more
Vasovagal syncope with asystole; Vasovagal syncope with asystole; This is a spontaneous report from a contactable pharmacist (patient). A 36-year-old female patient received the second dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EJ1686), via an unspecified route of administration in the right arm on 11Jan2021 at 14:45 at 36-years-old at a single dose for COVID-19 immunization in a hospital. Medical history included Wilms tumor from an unknown date and unknown if ongoing, Kidney resection and chemo from 1986 to an unknown date, sulfonamide allergy from an unknown date and unknown if ongoing, premature ventricular contractions (PVCs) from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EH9899) for COVID-19 immunization on 21Dec2020. On 12Jan2021 at 04:00, the patient experienced vasovagal syncope with asystole (hospitalization, medically significant). The patient was hospitalized for vasovagal syncope with asystole on unknown dates for 4 days (at the time of the report). It was reported that the patient did not receive any treatment due to the events. The clinical course was reported as follows: The patient experienced what was believed to be a vasovagal syncope with asystole; approximately 12 hours after receiving the second dose. The patient had been admitted to the hospital since all cardiac diagnosis tests were negative for structural or functional abnormalities. The patient remained in-patient at this time for initiation of therapy for frequent PVCs, which were diagnosis about one year ago; but chose not to treat at that time, as the symptoms were not affecting her lifestyle. The patient underwent lab tests and procedures which included cardiac diagnosis tests: negative for structural or functional abnormalities on an unknown date. The clinical outcome of the events was recovering. The patient did not have COVID prior to vaccination; and was not tested for COVID post vaccination.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect BNT162B2 in the development of the vasovagal syncope with asystole cannot be excluded. The event is confounded by the patient's underlying premature ventricular contractions. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
36 2021-02-04 anaphylactic reaction hives started to appear on her body/hives on her neck; nauseous/ was going to throw up; dizzy; diffi... Read more
hives started to appear on her body/hives on her neck; nauseous/ was going to throw up; dizzy; difficulty breathing (wheezing); difficulty breathing (wheezing); injection site soreness; She was hot, flush; difficulty swallowing; the tongue started swelling/Swollen tongue; Anaphylactic reaction/anaphylaxis; This is a spontaneous report from a contactable consumer reported for self. This 36-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 20Jan2021 12:52 left arm at single dose (Lot: EL3247) for covid-19 immunisation. Medical history included ongoing Anaphylaxis to Walnuts, Oranges, and morphine, ongoing allergy to a steroid cream Kenalog, and a steroid powder which she broke out immediately and ongoing Colitis. Concomitant therapy was none. She received the first dose of the vaccine yesterday on 20Jan2021 12:52 and 10 minutes later (20Jan2021 13:02) the tongue started swelling/Swollen tongue so they gave her Benadryl to try to stop it but it didn't help enough, hives started to appear on her body so they gave her a dose of epinephrine in the right arm and put on an IV, because she was feeling nauseous and dizzy. She started to feel better and was transferred to the hospital, when she was in the hall of the hospital she started having difficulty breathing (wheezing) and difficulty swallowing so she received another dose of Epinephrine (EpiPen) and also Benadryl, Prednisone and Pepcid. She went home and was taking Prednisone (1 daily), Benadryl and salbutamol (twice daily). She went into anaphylaxis within 15 minutes of receiving it on 20Jan2021. She brought 2 Epi injections with her. They monitored at the hospital for a few hours. She knows exactly how it happened. She was sitting in the observation room. She had told them multiple times that she had allergies before. She came in with two Epi pens and Benadryl. She let them know that as well. She was very verbal that she has history of anaphylaxis. They gave it to her. They said they were going to monitor her for 30 minutes. Her tongue started to swell 10 minutes after. She was sent to the paramedic tent. She took liquid children's Benadryl to try to stop the reaction. It did not help. She clarified it just didn't work enough to delay it. She doesn't have UPC, but provided the following information from the bottle: PLD-H242C LB004314 Lot WJ00896 Expiration Feb2023. She then started getting hives on her neck. She was hot, flush, and dizzy. She felt like she was going to throw up. That passed. They then gave her Epi in the opposite arm, her right arm. She got the COVID vaccine in her left arm. Then, they got her ready to go to the hospital. The transfer was smooth. She was waiting for intake when she started to not be able to swallow. She complained quickly. The nurses ran to get Epi, but the paramedic grabbed the patient's Epi pen and injected it in her thigh. She was IVed up at the vaccine center before transfer. They gave her Benadryl, Pepcid, and methyl prednisone. The Epi pen they gave her was her own shot. They monitored her a few hours. Then sent her home with Pepcid, more Epi pens, and Prednisone for 4 days. She has had normal soreness in her arm at the injection site. It has been status quo, it feels like a tetanus shot. She still has swelling in tongue, but they told her that might take a day or two to go away. She is supposed to also take Benadryl for the next 2 days. She was given the vaccine at the (Place name). Events visit to Emergency Room. They did a CBC and she was in normal range for everything. Lab data included on 20Jan2021: CBC normal. Outcome of the event Swollen tongue was recovering. Outcome of the event Anaphylactic reaction/anaphylaxis was recovered. Outcome of the event injection site soreness was not recovered. Outcome of the events was unknown.
36 2021-02-10 low blood platelet count Developed ITP, currently in the hospital getting treated with dexamethasone 40 mg daily
36 2021-03-01 vaginal haemorrhage **22 Weeks pregnant. Due date 7/1/21. 1st pregnancy** The day after the vaccine around 3pm I had cra... Read more
**22 Weeks pregnant. Due date 7/1/21. 1st pregnancy** The day after the vaccine around 3pm I had cramps and light spotting. The nurse on call advised me to go to the ER. I went to ER, they ran an ultra sound and all kinds of test, they said everything looked good they thought it was a Fibroid. They discharged me, and that night at 11:30pm I had a very big and fast bleed around a cup of blood and went back to the ER. That time I went to hospital because it was closer. Again they did an ultrasound and thought it was a Fibroid. I ended up seeing my OB GYN 2/8/21, she said she didn't think it was a Fibroid and sent me to get an ultrasound on 2/12/21. At that point after the bleed I had 4 days of spotting. When I went to the ultrasound they said I had a partial placenta abruption and my cervex has shortened. Since then everything has been fine.
36 2021-03-14 anaphylactic reaction Patient with anaphylaxis to COVID-19 vaccine. Onset of symptoms occurred five minutes after receivi... Read more
Patient with anaphylaxis to COVID-19 vaccine. Onset of symptoms occurred five minutes after receiving vaccine. Urticarial rash occurred on chest and abdomen. Shortly after, she developed a wheeze. EMS was onsite so they administered methylprednisolone, diphenhydramine, Zofran, Phenergran and epinephrine IM. Second and third dose of epinephrine was administered due to partial response from previous doses. Patient was taken to Health care hospital for further evaluation and treatment.
36 2021-03-24 pneumonia bilateral pneumonia; fever; This is a spontaneous report from a contactable Nurse. A 36-year-old fem... Read more
bilateral pneumonia; fever; This is a spontaneous report from a contactable Nurse. A 36-year-old female patient (non-pregnant) received BNT 162B2 (Pfizer-BioNTech Covid-19 Vaccine, solution for injection, batch/lot number EN6202 expiration date unknown) via an, intramuscular route of administration on 09Mar2021, at single dose for COVID-19 immunisation. The patient had no known allergies. The patient's medical history included Diabetes type 2. Concomitant medication was not reported. It was unknown if other vaccine was given in four weeks, other medications in two weeks was reported as yes. Patient reported a fever on 13Mar-14Mar which progressed to confirmed diagnosis of bilateral pneumonia. The adverse event start date was 13Mar2021. No covid prior to vaccination. On 15Mar2021, covid test post vaccination was performed (Nasal Swab/Antigen and PCR) the test result was Negative. Treatment received was antibiotics. The outcome of event was Not recovered/Not resolved.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events pneumonia and fever and the suspect drug. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
36 2021-03-25 anaphylactic reaction Received the vaccine at 10:40am on 3/24/2021 and felt normal. At 1:20pm anaphylaxis set in - experie... Read more
Received the vaccine at 10:40am on 3/24/2021 and felt normal. At 1:20pm anaphylaxis set in - experienced tingling then tightness in throat, tongue swelled, swallowing would cause me to choke and tongue would get stuck blocking air passage. Hyperventilating began as I could not get enough air into my lungs. For 15 minutes tried drinking water and laying down to help open airways. Breathing slightly eased for 2-4 minutes and then the anaphylaxis would spike again. This happened 3x getting worse, I called my Primary Care Physician's office and was advised to go to the ER immediately. At 2:15pm I arrived at the ER and at 2:30pm I was given a 1mg shot of EPINEPHrine, and intravenous shots of diphenhydrAMINE, methylPREDNISolone, and famotidine along with oxygen. Anaphylaxis finally dissipated around 3:30pm and by 5pm I was breathing more normally. I was discharged at 7:00pm, and was feeling very energized. I was also given a prescription for an epipen incase I should have any further issues. The next morning, 3/25/2021 I woke up after 5 hours of sleep feeling extremely energized. I had a virtual doctor's appointment with my allergist, Dr. at 12:00pm. My doctor was surprised at how well I seemed to be doing and we made arrangements to do further allergy tests in 2 weeks. We came to the conclusion that I am most likely allergic to POLYETHYLENE GLYCOL. This ingredient is also in a cold medicine that I was taking in January and I was experiencing minor anaphylaxis (which I thought was due to the extreme congestion I was experiencing with the cold). It is also an ingredient (aka PEG) in an eye cream that caused a severe eczema patch under my eye in January. After my appt, at 1:30pm I went into anaphylaxis again. My throat got tingley and began to close, my tongue swelled and again was getting stuck in my throat when I attempted to swallow. I laid down and tried to get in deep breaths. My husband bought children's BENADRYL, which does not have polyethylene glycol in it, and gave me 15ml at 2:15pm. I reached out to my allergist, Dr. and updated him. He advised that I immediately take an additional 5ml of the BENADRYL. Dr. prescribed me 60mg/day Prednisone for 2 days followed by 40mg/day of Prednisone for 4 days, 40mg/day Famotidine for 2 weeks, 10mg/day antihistamine (I chose loratadine) for 2 weeks. Dr. also shared that I should have been prescribed steroids when I was discharged from the hospital, but my energetic state gave the impression I was OK. My manic energy was a result of the epinephrine, which had finally worn off 23 hours later, causing my body to begin the allergic reaction all over again. The evening of 3/25/2021 (after the first dose of 60mg prednisone, 40mg famotidine, and 10mg loratadine) and all three meals on 3/26/2021 I experienced minor anaphylaxis when I began to eat. Tightness in throat throughout the meal and lasting an additional 20 minutes following the meal. My throat has reopened after each incident on 3/26/2021 and I was able to breathe normally again.
36 2021-03-31 anaphylactic reaction Severe anaphylactic. Tongue swollen throat swollen. Facial swelling throat swelling. First occurr... Read more
Severe anaphylactic. Tongue swollen throat swollen. Facial swelling throat swelling. First occurred at 10:50. Epi pen given. Second wave of symptoms at 1. 2nd dose epi given to leg and went to emergency room
36 2021-04-09 vaginal haemorrhage 1) Severe headache on 3/27/2021 - one day after second shot. Resolved within 24 hours with Tylenol. ... Read more
1) Severe headache on 3/27/2021 - one day after second shot. Resolved within 24 hours with Tylenol. Headache happened again 5 days after shot. 2) Unusual heavy, bright red bleeding from vagina during/after sex - has never happened before. On 4/3 and 4/6 on cycle days 11 and 14 respectively after period. Period was 3/24-3/28.
36 2021-04-12 pulmonary embolism, deep vein blood clot 1st covid vaccine given on 1/18/21, 2nd covid vaccine given on 2/8/21. On 2/17/21 I was experienci... Read more
1st covid vaccine given on 1/18/21, 2nd covid vaccine given on 2/8/21. On 2/17/21 I was experiencing mild shortness of breath, but did not seek medical help as the symptoms would come and go and were not severe. On 2/22/21 I had an outpatient hernia repair surgery. On 2/23/21, I began experiencing shortness of breath and dizziness on exertion. This continued throughout the next many days. On 3/1/21 I had sudden onset of dizziness, tachycardia, shortness of breath. I was admitted to the hospital with bilateral DVT and PE.
36 2021-04-12 vaginal haemorrhage foggy/light headed, dizzy, nauseous, severe body aches, migraine, stomach cramps and bleeding (not c... Read more
foggy/light headed, dizzy, nauseous, severe body aches, migraine, stomach cramps and bleeding (not currently on my cycle), chills and fever, extreme pain from hip down. Legs were ice cold and felt like I had frostbite.
36 2021-04-22 excessive bleeding Livedo Reticularis (lattice hemorrhage): Inner left leg from groin to foot. Inner right leg groin to... Read more
Livedo Reticularis (lattice hemorrhage): Inner left leg from groin to foot. Inner right leg groin to knee. Pain in both legs and left arm, which also remains swollen and painful 24 days later. Additional swelling top - both feet. NOTE: Patient has IDENTICAL twin (verified by DNA) who had the Moderna vaccine and developed Livedo Reticularis after 2nd shot I have photos I can send.
36 2021-04-23 vaginal haemorrhage moderate vaginal bleeding; This is a spontaneous report from a contactable consumer or other non hcp... Read more
moderate vaginal bleeding; This is a spontaneous report from a contactable consumer or other non hcp. A 36-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on 16Jan2021 13:00 (Batch/Lot Number: EL3248) as single dose, dose 2 via an unspecified route of administration, administered in Arm Right on 06Feb2021 (Batch/Lot Number: EL9269) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously experienced drug hypersensitivity. The patient reported that about 12-18 hours after getting the 1st and 2nd shot she experienced light to moderate vaginal bleeding for 2-3 hours and then it cleared up. Both times she was not near her mensural cycle. The patient did not have any other vaccine in four weeks. The patient was not priorly Covid vaccinated. The patient was not tested Covid post vaccination. The outcome of the event was reported as recovered on an unspecified date 2021.
36 2021-04-24 cerebrovascular accident This is a spontaneous report from a contactable consumer. A 36-year-old female patient received the ... Read more
This is a spontaneous report from a contactable consumer. A 36-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) lot number and expiration date not provided, via an unspecified route of administration, administered in left arm on 07Apr2021 16:20 as single dose for Covid-19 immunisation. Medical history included attention deficit hyperactivity disorder (ADHD) was advised because she has been in her house so long that she is basically an agoraphobe and psychologist qualified because diagnosed with ADHD and profound anxiety at the fear of dying from COVID, anxiety and Covid-19, Concomitant medications were not reported. The patient stated that yesterday 07Apr2021 she got her first round of Pfizer COVID-19 vaccine and came home and got the worst headache she ever had in her life. She states then she projectile vomited and started uncontrollably shaking. The patient stated that she was shaking uncontrollably so bad she had to take a bath. She once she took a bath, in the bath she was shaking, it was not until she raised her body temperature high enough that her body was like okay, it could let go a little bit, then she got into bed and the shaking started again. She stated she had to use her heating blanket and stayed in bed all night with it and she is still using it now. She doesn't know how she would be if she wasn't warm, she thinks the fact that she is warm, the shaking has subsided. Later, last night, around 2 or 3 the headache was piercing, her head was hurting so bad like someone was taking a nail in her left temple. If it was a stroke she would have dealt with it if she had someone there with her to help her deal with it. She has a horrible headache today. The patient stated that now it is like a regular migraine. It sounded crazy to say , but now it she stated that it was like a regular migraine, it has improved and no longer feels like she is having a stroke. The patient took two Tylenol yesterday for the headache and vomited pretty quickly after so she doesn't think she got much of it. She has not taken anything else because she does not have anything on her stomach so she does not want to take more Advil or whatever but she would like to, her head hurts really bad, she would love some pain relief. The projectile vomiting went until there was just bile. She did not eat very much yesterday. She is no longer actively vomiting, but she felt herself wanting to dry heave but feels there is nothing else to give. The patient stated that she hasn't eaten anything today so she does not know if she can keep anything down and doesn't have much water in her system. The outcome of the event headache was recovering while the outcome of other events was unknown. Follow-up attempts are completed. No further information is expected.
36 2021-04-26 vaginal haemorrhage Vaginal bleeding. Light spotting the day after vaccine which continued into the next day as well as... Read more
Vaginal bleeding. Light spotting the day after vaccine which continued into the next day as well as the wound day which was heavier bleeding. On day 13 of cycle on the day of vaccination. Mid cycle spotting/bleeding is highly unusual for me.
36 2021-04-27 vaginal haemorrhage Spotting (vaginal bleeding) and mild cramps for a few hours. I have had IUDs for 6+ years and no per... Read more
Spotting (vaginal bleeding) and mild cramps for a few hours. I have had IUDs for 6+ years and no periods during that time until this. It was very mild and didn't last more than a day.
36 2021-04-28 anaphylactic reaction Facial tingling 40 minutes after shot. Anaphylactic reaction 3 am, Bell?s palsy 11am.
36 2021-04-28 blood clot, deep vein blood clot Patient had vaccine on 4/23/21 and developed calf pain on 4/26/21. No other symptoms. No other tr... Read more
Patient had vaccine on 4/23/21 and developed calf pain on 4/26/21. No other symptoms. No other triggers known at that time for a DVT. US did confirm a small blood clot
36 2021-04-28 blood clot 1.5 weeks after my first shot I started my period 1 day early. Everything was fine the first day but... Read more
1.5 weeks after my first shot I started my period 1 day early. Everything was fine the first day but by the afternoon of day 2 I was bleeding extremely heavy and several very large blood clots past in a matter of minutes. I called consulting nurse who told me to go to the ER immediately. I then went to the ER for treatment. They did some tests and sent me home and told me to watch my symptoms closely for the next few days. This was last night and I have no change today. I'm still bleeding very heavily and passing large clots. I have never in my life experienced a period of this nature.
36 2021-05-03 stroke, cerebrovascular accident Cerebral infarction CVA cerebral vascular accident
36 2021-05-04 heart attack According to the patient she had a minor heart attack She was seen by MD
36 2021-05-04 pulmonary embolism chest pressure and pain a little over 12 hours following second vaccination; CT scan with dye/contra... Read more
chest pressure and pain a little over 12 hours following second vaccination; CT scan with dye/contrast revealed a pulmonary embolism
36 2021-05-06 blood clot blood clot; anemia; knee down felt tingly/like her legs were falling asleep; knee down felt tingly/l... Read more
blood clot; anemia; knee down felt tingly/like her legs were falling asleep; knee down felt tingly/like her legs were falling asleep; could not sleep; She was feeling uncomfortable constantly/she did not feel well; Shortness of breath; Her arm started hurting/was just at the injection site; This is a spontaneous report from a contactable consumer. This consumer (patient) reported for herself that a 36-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EP7533) at the age of 36-years, via an unspecified route of administration in left arm on 04Apr2021 12:15 at single dose for COVID-19 immunisation. Medical history included had a pregnancy (a while ago, not ongoing). No other products. The patient stated that she experienced shortness of breath on 08Apr2021 (4 days after receiving the first dose), it got so severe on day 7 that she went to the ER on 11Apr2021. She started getting progressively more shortness of breath. Twice, she called the nurse line for her doctor and was advised to go to the emergency room. Added she could not catch her breath, and it was worse at night, could not sleep, so she went to the emergency room, she was in emergency room for 2 and a half hours and then went home. She wanted to know if the second dose could cause issues or if she should get it, added that the paperwork said that people should not get the vaccine if they received an adverse reaction to the first dose or any vaccination. She did not know if this was normal for it to get progressively worse and 2 to 14 days later. Patient wanted to know if the shortness of breath was something that can get worse, if this was a reaction to the vaccine even though it happened so many days later. Patient added it was the only thing she could think of and that her heart rate, oxygen levels, and everything was good minus she felt like she could not catch her breath. The doctor in the ER gave her anti-anxiety medicine, something with an L, but the doctor gave her that and it really seemed to help. It was kind of like, she did not know, it made her feel calm enough to fall asleep. Caller added that she has that and an salbutamol (ALBUTEROL) inhaler. She was not sure whether progressively worsening shortness of breath had gotten any better or was still going on, added that yesterday was the day she did not need either treatment medication. The day before, she took just the anxiety medicine and not the albuterol. Yesterday, she took none. During the day on 11Apr2021 (Sunday), she had called because she was feeling uncomfortable constantly. She has two children and all day she did not feel well. She told her husband she did not feel well at all. Sunday when she went to lay down, she could not sleep. Patient reported that as her shortness of breath subsided, her arm started hurting again, thought this began on 19Apr2021 and was not sure, it went away completely and was just at the injection site, probably lasting half a day or so and then it went away, clarified as left arm, same as injection. Caller added that 15Apr2021 was after the ER visit, was that she was standing up doing things and from her knee down felt tingly. Stated that knee down felt tingly on 15Apr2021, which was after her ER visit occurred, she was standing up and doing things. She had not been doing things for long periods but her knee down felt tingly. Added not like numb, but like her legs were falling asleep. She was preparing dinner and moving around and felt tingling in both legs. This probably lasted about three hours. She just kind of took it easy and it started to subside and then it was gone. While mentioned investigations, patient stated the ER did an EKG, where they put stickers and monitor her heart. They did a chest x-ray, and they took blood. She believed they checked for blood clot tests and anemia. Patient did not know any results but stated the doctor came into the room and told her everything was clear and nothing came back with anything on it. She stated the date was either the night of 11Apr2021 or the morning of 12Apr2021 for the tests. Outcome of the events shortness of breath and arm hurting was recovered/resolved in Apr2021; of the event knee down felt tingly/like her legs were falling asleep was recovered/resolved on 15Apr2021; while of remain was unknown. No follow-up attempts are needed. No further information is expected.
36 2021-05-07 stroke, cerebrovascular accident This 36 year old female received the Pfizer Covid shot on 4/17/21 and went to the ED on 4/20/... Read more
This 36 year old female received the Pfizer Covid shot on 4/17/21 and went to the ED on 4/20/21 and was admitted on 4/20/21 with the following diagnoses listed below. I63.9 - Cerebral infarction, unspecified I63.9 - CVA (cerebral vascular accident) (CMS/HCC)
36 2021-05-08 anaphylactic shock Anaphylactic Shock
36 2021-05-09 vaginal haemorrhage Vaginal Spotting and slight cramps approx 24 hours after initial shot - continued spotting for 3-4 d... Read more
Vaginal Spotting and slight cramps approx 24 hours after initial shot - continued spotting for 3-4 days. Missed/late menstrual cycle (currently 7 days late) No pregnancy
36 2021-05-10 excessive bleeding Bleeding; heavier menstrual bleeding; Along with a week and a half of heavy Fatigue; Sneexzing; Alle... Read more
Bleeding; heavier menstrual bleeding; Along with a week and a half of heavy Fatigue; Sneexzing; Allergies; Hot flashes; Nausea waves for two weeks; This is a spontaneous report received from a contactable consumer (patient). A 36-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 10Apr2021 (Batch/Lot Number: EW0151) as 2ND DOSE, SINGLE for covid-19 immunization, at the Age at Vaccination of 36 years old. The patient medical history was not reported. Patient was not Pregnancy at time of Vaccination. Historical vaccine included first dose of BNT162B2 on 20Mar2021 (Lot number: EP6955; Dose number=1; Vaccine location=Left arm) for covid-19 immunization, reported the first shot she had a slight headache hours after the shot and then got light embryos bleeding a few day afterwards. Concomitant medications (medications the patient received within 2 weeks of vaccination) included Implanon, Straterra, adderall, multivitamin, ashwa (as reported), all taken for an unspecified indication, start and stop date were not reported. The patient experienced bleeding (medically significant), along with a week and a half of heavy fatigue (non-serious), sneexzing (non-serious), allergies, hot flashes, nausea waves for two weeks (non-serious), heavier menstrual bleeding (non-serious), all on 25Apr2021 with outcome of unknown. Reported as she never have period due to her birth control methods. She got heavier bleeding a few days after her second dose that lasted about a week, along with a week and a half of heavy fatigue, Sneexzing and feeling like she had allergies, with occasional hot flashes and nausea waves for two weeks. And even heavier menstrual bleeding starting 15 days after second shot. No treatment received for events. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient not been tested for COVID-19. Information on Lot/Batch number was available. Additional information has been requested.
36 2021-05-11 excessive bleeding The first shot I had a slight headache hours after the shot and then got light embryos bleeding a fe... Read more
The first shot I had a slight headache hours after the shot and then got light embryos bleeding a few day afterwards; The first shot I had a slight headache hours after the shot and then got light embryos bleeding a few day afterwards; This is a spontaneous report from a contactable consumer. A 36-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955), dose 1 via an unspecified route of administration, administered in the left arm on 20Mar2021 as single dose for covid-19 immunization. The patient medical history was not reported. Concomitant medication included etonogestrel (IMPLANON) taken for an unspecified indication, start and stop date were not reported; amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) taken for an unspecified indication, start and stop date were not reported; ashwagandha (ASHWAGANDHA) taken for an unspecified indication, start and stop date were not reported. The patient was also taking unspecified multivitamins. No other vaccines were administered within four weeks of vaccination. On an unspecified date in 2021, the patient noted with the first shot I had a slight headache hours after the shot and then got light embryos bleeding a few day afterwards. Details were as follows: patient noted that she never had period due to birth control methods. Following the first shot, she had a slight headache hours after the shot, and then got light embryos bleeding a few day afterwards. No treatment was given for the events. No COVID infection was noted prior to the vaccination, no COVID test was performed post vaccination. The outcome of events was unknown.
36 2021-05-11 vaginal haemorrhage VAGINAL BLEEDING - PREGNANT Threatened abortion
36 2021-05-12 blood clot began having severe cramping and heavy bleeding with clots the next day; Started menstrual cycle a w... Read more
began having severe cramping and heavy bleeding with clots the next day; Started menstrual cycle a week early a day after getting second dose; began having severe cramping; heavy bleeding with clots the next day; This is a spontaneous report from a contactable consumer (patient). A 36-year-old female patient received bnt162b2 (BNT162B2, Pfizer COVID 19), dose 2 via an unspecified route of administration, administered in left arm on 26Apr2021 08:45 (Lot Number: unknown) as single dose for covid-19 immunization. Medical history included Anemia, ulcerative colitis, intracranial hypertension. None allergies reported. Concomitant medications included iron taken for anaemia. The patient received dose 1 on 01Apr2021 07:45 in right arm for covid-19 immunization. The patient started menstrual cycle a week early a day after getting second dose. The patient began having severe cramping and heavy bleeding with clots the next day 27Apr2021. No treatment received. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19, Since the vaccination, patient has not been tested for COVID-19. The outcome was recovering. Follow up attempts are needed. Further information has been requested.
36 2021-05-13 excessive bleeding 4/20 vaccination 4/28 Started bleeding, cramping 4/29 persistent cramping, bleeding. I went to the E... Read more
4/20 vaccination 4/28 Started bleeding, cramping 4/29 persistent cramping, bleeding. I went to the ER and had had blood work done the day before positive 4.5 -5 weeks pregnant. *CHEMICAL MISCARRIAGE
36 2021-05-14 anaphylactic shock preeclampsia level migraines; soreness at shot site; joint pain; chills; 104.0 fever/103 fever; I wa... Read more
preeclampsia level migraines; soreness at shot site; joint pain; chills; 104.0 fever/103 fever; I was itchy all over for a few nights; weird lump in my armpit by my breast; 3rd time CMV has reactivated; 3rd time CMV has reactivated; Anafalactic shock; This is a spontaneous report from a contactable consumer (patient). A 36-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot: EW0158), via an unspecified route of administration in left arm on 26Apr2021 14:45 (at the age of 36-years-old) as 2 nd dose, single for covid-19 immunisation. The vaccination facility type was a hospital. The patient received first dose of bnt162b2 (Lot no: ER8729) on 05Apr2021 at 14:45 in left arm for COVID-19 immunisation and experienced cytomegalovirus (CMV). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19 and since vaccination, patient was not tested for COVID-19. Medical history included CMV; HELLP syndrome and preeclampsia, all when she delivered her son 3 weeks early and pregnant. Concomitant medications included ferrous sulfate; amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) and unspecified prenatal vitamins. The patient reported 3 rd time CMV has reactivated in 2021. After 2nd vaccine dose (on 26Apr2021), soreness at shot site and joint pain. Late that night, chills, 104.0 fever. Next day (on 27Apr2021), 103 fever took paracetamol (TYLENOL) 4-6 hrs. Third day after (on 29Apr2021), 103 fever, still joint pain, & preeclampsia level migraines. Still had Rx migraine meds but couldn't mix with fever reducer. So took leftover oxycodone from having a baby at midnight and 05:00. Next day/4th post shot day (30Apr2021), severe migraine, fever staying around 100.something. So the patient took migraine medicine, melatonin (3 mg a few times that night). The melatonin was kinda helpful. In 2021, the patient was itchy all over for a few nights (been in anafalactic shock 3x prior so the patient knew it wasn't that) joint pain, now she have a weird lump in her armpit by her breast that hasn't gone away. Almost woke her husband to go to hospital because of migraine. The case was considered non-serious as did not result in death, non-life threatening, did not cause/prolong hospitalization, not disabling/incapacitating and no congenital anomaly/birth defect. The outcome of the event axillary mass was not recovered while for the remaining events was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021509886 baby case
36 2021-05-14 pulmonary embolism found a blood clot in right lung (pulmonary embolism) with no prior blood clot issues; Chest pressur... Read more
found a blood clot in right lung (pulmonary embolism) with no prior blood clot issues; Chest pressure and pain, found a blood clot in right lung (pulmonary embolism) with no prior blood clot issues; Chest pressure and pain, found a blood clot in right lung (pulmonary embolism) with no prior blood clot issues; This is a spontaneous report from a contactable consumer (patient). A 36-year-old female patient (not pregnant) received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot/batch number and expiration date unknown), via an unspecified route of administration, administered in Left arm on 04May2021 at 09:00 AM (at the age of 36-year-old) at single dose for COVID-19 immunisation. Medical history included Hypothyroidism, previous experience with WPW (wolff-parkinson-white) syndrome and SVT (Supraventricular tachycardia), known allergies with Penicillin and latex. No COVID prior vaccination. Concomitant medication included levothyroxine sodium (SYNTHROID, strength: 88 ug). The patient previously received first does of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiration date unknown) administered in Left arm on 13Apr2021 at 07:45 PM (at the age of 36-year-old) at single dose for COVID-19 immunisation. No other vaccine received in four weeks. The patient experienced chest pressure and pain, found a blood clot in right lung (pulmonary embolism) with no prior blood clot issues on 05May2021 at 02:30 AM. Events were resulted in emergency room/department or urgent care, life threatening illness (immediate risk of death from the event). Therapeutic measures were taken as a result of all events included began taking apixoban immediately. No COVID tested post vaccination. The outcome of the events was not recovered. Information on the lot/batch number has been requested.
36 2021-05-19 heart attack Mild heart attack,Raised triponin levels; Mild heart attack,Raised triponin levels; This is a sponta... Read more
Mild heart attack,Raised triponin levels; Mild heart attack,Raised triponin levels; This is a spontaneous report from a contactable consumer (patient). A 36-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot Number: Er8729), via an unspecified route of administration, administered in Arm Left on 10Apr2021 (36-years-old) as 1st dose, single for COVID-19 immunization. The patient medical history included that prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. Facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store. Patient was not pregnant at time of vaccination. Concomitant medications were not reported. The patient experienced mild heart attack, raised triponin levels on 12Apr2021 with outcome of recovering. The patient underwent lab tests and procedures which included Nasal Swab: negative on 12Apr2021. The adverse events resulted in Emergency room/department or urgent care. Treatment received for the adverse event was Medication, Angiogram, ultrasound, bloodwork, cats. Therapeutic measures were taken as a result of events.
36 2021-05-20 vaginal haemorrhage *abnormal vaginal bleeding *pain in hips, knees, ankles *2 days of diarrhea *spleen pain *left side ... Read more
*abnormal vaginal bleeding *pain in hips, knees, ankles *2 days of diarrhea *spleen pain *left side lymph node pain esp in neck area *under armpit pain with under the shoulder blade pain *numbness and tingling in hand and feet and now just tingling in finger tips
36 2021-05-20 vaginal haemorrhage *painful lymph nodes all on left side esp in neck *pain in spleen *pain in hips, knees, and ankles b... Read more
*painful lymph nodes all on left side esp in neck *pain in spleen *pain in hips, knees, and ankles b/l *pain behind shoulder blade area left side *numbness and tingling in hands and feet which has transitioned to just tingling in b/l finger tips *abnormal vaginal bleeding
36 2021-05-21 anaphylactic shock Anaphylactic shock, patient passed out couldn?t breathe, talk, impaired speech, and epinephrine was ... Read more
Anaphylactic shock, patient passed out couldn?t breathe, talk, impaired speech, and epinephrine was administered
36 2021-05-21 pulmonary embolism I gave birth to a healthy baby boy who was 4 weeks early on 5/10/21. I had developed severe preecla... Read more
I gave birth to a healthy baby boy who was 4 weeks early on 5/10/21. I had developed severe preeclampsia the week prior and had to be induced. The baby weight 6lbs 140z. I developed a pulmonary embolism on 5/14, just four days after delivering. I do not take birth control pills nor have I ever smoked. I do not have a personal or family history of blood clots. I was in the hospital from 5/14-5/16 for management of the PE. I am now on blood thinners for at least 3 months. The doctors are not positive as to where the clot came from, but think possibly the ovarian vein which is very rare. CT scan did not show any active thrombus, just signs of inflammation to that are. Bilateral lower extremity Doppler ultrasounds were negative. I will be worked up by hematology to make sure I do not have a clotting disorder as a clot from the ovarian vein is so rare.
36 2021-05-22 blood clot Nosebleeds with clots 2 times a day.
36 2021-05-27 pulmonary embolism I developed a pulmonary embolism; BNT162B2 on 08Jan2021 as 1st dose, on 26Jan2021 as 2nd dose; I was... Read more
I developed a pulmonary embolism; BNT162B2 on 08Jan2021 as 1st dose, on 26Jan2021 as 2nd dose; I was only four days out from delivering a healthy baby boy when I developed a pulmonary embolism; This is a spontaneous report from a contactable healthcare professional (patient herself). A 36-year-old female patient received BNT162B2 (BNT162B2), via an unspecified route of administration in right arm on 26Jan2021 11:00 (Batch/Lot Number: EL1283) as 2nd dose, single; and via an unspecified route of administration in left arm on 08Jan2021 16:15 (Batch/Lot Number: EK5730) as 1st dose, single for COVID-19 immunization. The patient's medical history was not reported. Concomitant medications included vitamin B6, escitalopram oxalate (LEXAPRO), diphenhydramine hydrochloride (UNISOM), and prenatal vitamin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. She was not diagnosed with COVID-19 prior to vaccination. The patient reported "I was only four days out from delivering a healthy baby boy when I developed a pulmonary embolism (on 14May2021). I was treated in the hospital from 14May2021 - 16May2021. I am home now and am on anticoagulant medication for an extended period of time. Event resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. She was treated with IV heparin drip/blood pressure medicine. The patient was 18 Weeks pregnant at the onset of the event and was due to deliver on 10May2021. The patient underwent Covid test: negative on 09May2021 (Nasal swab). Outcome of the event was recovering.; Sender's Comments: Based on the information provided, the event pulmonary embolism is considered unlikely related to suspect product BNT162B2 (BNT162B2), (Batch/Lot Number: EL1283) as 2nd dose, single; and (Batch/Lot Number: EK5730) as 1st dose, single for COVID-19 immunization. The event occurred 3 months 18 days after the last dose of the suspect product.
36 2021-05-27 blood clot, blood clot in lung Blood clots in lung and leg; Blood clots in lung and leg; Dizziness; Weakness; Headache; shortness o... Read more
Blood clots in lung and leg; Blood clots in lung and leg; Dizziness; Weakness; Headache; shortness of breath; This is a spontaneous report from a contactable consumer (patient). A 36-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the left arm on 29Apr2021 16:00 (Batch/Lot Number: EW0162) as 2nd dose, single dose for COVID-19 immunization. The patient received the first dose of COVID-19 vaccine on 08Apr2021 17:45 left arm for COVID-19 immunization. Medical history included fibromyalgia and had covid-19 prior to vaccination. Concomitant medications included gabapentin; ethinylestradiol, norgestimate (ORTHO-CYCLEN); and diclofenac sodium (DICLOFENAC SODIUM); all taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 30Apr2021 05:00, the patient had blood clots in lung and leg, dizziness, weakness, headache (still after a month) and shortness of breath. As a result of the events, the patient visited doctor or other healthcare professional and has been to the emergency room. The events required hospitalization and was considered a life-threatening illness (immediate risk of death from the event). The patient was hospitalized for two days. The patient was put on blood thinners as treatment for the events. The patient has not recovered from the events.
36 2021-05-30 anaphylactic reaction She received her second dose of the Pfizer Covid vaccine on 5/27 and had expected fatigue/chills/mya... Read more
She received her second dose of the Pfizer Covid vaccine on 5/27 and had expected fatigue/chills/myalgias for the first 2 days. On Sunday evening she developed a full-body rash which started on her back and torso. The rash was itchy, small, red, raised lesions which coalesced into multiple patches on her bilateral upper and lower extremities. The rash is worst now on her lower extremities. She took one half of a tablet of Benadryl at 11:00. She began to develop left-sided angioedema of her lips and bilateral eyelid swelling. She took a full tablet of Benadryl at 1600 and called to the nursing line for her PCP and was advised to present to the ED. She did not have any trouble breathing. She has no voice changes. She did feel lightheaded this morning. She has not felt nauseous or had vomiting or diarrhea. She has had no new exposures, no new detergents/soaps/clothing, has not spent extra time outside. She has no known allergies but notes sensitive skin and some food sensitivities. Upon arrival to the ED, she is afebrile with elevated heart rate and blood pressure, with normal oxygen saturation and no respiratory distress on room air. On exam, she has bilateral eyelid swelling, mild left lip angioedema, and diffuse maculopapular rash. Differential diagnosis includes anaphylaxis, vaccine reaction, allergic reaction to unknown allergen, viral process. She shows no signs of severe anaphylaxis, shock, or respiratory compromise. She was given cetirizine and famotidine for histamine blockade. Based on the lack of other systemic symptoms, steroids were not indicated.
36 2021-06-14 vaginal haemorrhage Vision changes: blurred vision Dizziness throughout the day Swelling and stiffness of knuckles Pass... Read more
Vision changes: blurred vision Dizziness throughout the day Swelling and stiffness of knuckles Passing blood clots similar to menstruation.
36 2021-06-22 blood clot looking for blood clots on her lungs/Suspected blood clot; she is having trouble breathing; caller's... Read more
looking for blood clots on her lungs/Suspected blood clot; she is having trouble breathing; caller's wife turned pale, trachea was closing; caller's wife turned pale, trachea was closing; This is a spontaneous report from a contactable consumer or other non hcp (patient's husband) through medical Information. A 36-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Historical vaccine information included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) 1st dose on an unknown date, for COVID-19 immunization. The caller's wife (patient) turned pale, and trachea was closing on 10Jun2021 while she is having trouble breathing and looking for blood clots on her lungs/Suspected blood clot on an unspecified date. Caller asked million-dollar question that who was going to pay for all of these bills? his wife has had two ambulance bills, one admission to ER, his wife right now was at the hospital. 45 minutes after receiving the second dose, caller's wife turned pale, trachea was closing. Caller contacted EMS, EMS gave Epi Pen and more medications. After 6-7 hours, his wife needed to be rushed again to hospital, but the fire station was closer. Caller knocked on their door for help and they transported wife to hospital. This happened yesterday 10Jun2021. Callers Wife had two Benadryl within the last two hours today (11Jun2021). She was admitted again today to the hospital. She does not have any medical conditions. She was 36 years. They were looking for blood clots on her lungs because she was having trouble breathing. Caller asked for us to contact her back in one hour (1757 11Jun) to continue the report. She was at the hospital. The seriousness for events was hospitalization. Therapeutic measures were taken as a result events which includes EPI PEN and BENADRYL. The clinical outcome for all events was unknown. Information about batch/Lot number has been requested.
36 2021-06-23 deep vein blood clot, blood clot Woke up that night with chills and numbness/tingling on right side. Went to the hospital and they fo... Read more
Woke up that night with chills and numbness/tingling on right side. Went to the hospital and they found a DVT Blood Clot on my right collarbone. Two days later my left side started getting numb/tingling in my foot and hand. 1 week later and I still have numbness and tingling on both sides.
36 2021-06-29 vaginal haemorrhage Earache; swollen ear; spot bleeding; This is a spontaneous report from a contactable physician, the ... Read more
Earache; swollen ear; spot bleeding; This is a spontaneous report from a contactable physician, the patient. A 36 -years-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: ER2613) via an unspecified route of administration in the left arm on 20Mar2021at 08:00 (at the age of 36-years -old) as a single dose for COVID-19 immunisation. The patient did not have any medical history and concomitant medication. The patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EL9269) via an unspecified route of administration in the left arm on 27Feb2021at 09:30 (at the age of 36-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. The patient had not tested for COVID-19. The patient not had any symptoms associated with COVID-19. The patient did not have allergies to medications, food, or other product. On 20Mar2021 at 20:00 the patient experienced earache, swollen ear and spot bleeding. The patient received Tylenol and diphenhydramine for the treatment of events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of earache, swollen ear, spot bleeding was recovering. No follow-up attempts are needed. No further information is expected.
36 2021-07-02 pulmonary embolism I was diagnosed with a pulmonary embolism on 5-26-2021. No other factors existed for this to happen ... Read more
I was diagnosed with a pulmonary embolism on 5-26-2021. No other factors existed for this to happen other than my vaccine. I am currently still fighting to recover while on blood thinners. I also developed a severe migraine after the first vaccine which lasted nearly a month and had me on and out of the ER.
36 2021-07-11 grand mal seizure Tonic Clonic Seizure 7/28/21 0550 Found by husband in bed seizing
36 2021-07-12 vaginal haemorrhage After the 2nd dose vaccine, I had fatigue and sore arm. I also had swelling of lymph node in my l... Read more
After the 2nd dose vaccine, I had fatigue and sore arm. I also had swelling of lymph node in my left arm pit for 1 week. About 5/10/2021 I did not get my menstrual cycle when expected. I am relatively very regular. On 6/16/2021, I had light spotting that day. On 6/27/2021 I did get my period. It was heavier than normal and lasted 3 days. My last normal period was in March 2021. So I basically did not get a period for 3.5 months. I am going to follow up with OBGYN and my appointment is on 7/28/2021 in 2 weeks.
36 2021-07-13 atrial fibrillation Within 5 minutes of getting the shot, I got a weird metallic/salty-saline taste in my mouth that las... Read more
Within 5 minutes of getting the shot, I got a weird metallic/salty-saline taste in my mouth that lasted until Saturday/Sunday. Also gradually within an hour, my left side of my mouth (cheek, bottom lip, gums) went completelt numb. That last until Saturday then it became tingly like for the next few days after that. I was able to use facial muscles, I just literally had no feeling. My heart started to have palpitations and I am pretty sure it went into AFib until Friday. I also felt like I had vertigo for the first 24 hours. I could not keep balance like I was very intoxicated. With my endometriosis, it did also cause a d Flare up in my back pelvic area like my endo has returned to my "cal de sac" area. That lasted a few days too.
36 2021-07-13 blood clot Extremely heavy, painful, and long period that came 4 days early. I've never experienced such bad cr... Read more
Extremely heavy, painful, and long period that came 4 days early. I've never experienced such bad cramping and bleeding with a period before. I am not coming up on my next period and the terrible cramps have begun again. Prior to the vaccine I rarely had cramps, and if I did they were minor. Now I am having such strong cramps that I can only lay down with a heating pad. The bleeding is heavier and clots.
36 2021-07-17 deep vein blood clot Chills; Numbness/tingling; Numbness/tingling; Knees also started making a tearing sound and are achy... Read more
Chills; Numbness/tingling; Numbness/tingling; Knees also started making a tearing sound and are achy; Knees also started making a tearing; DVT blood clot; This is a spontaneous report received from a contactable consumer (patient). A 36-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm at the age of 36-years-old on 16Jun2021 11:15 (Lot Number: EW0196) as single dose for covid-19 immunisation. Medical history was none. There were no concomitant medications. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient didn't received any other medications within 2 weeks of vaccination. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm at the age of 36-years-old on 26May2021 11:15 (Lot Number: EW0178) as single dose for covid-19 immunisation. After her second shot ,she woke up with chills and numbness/tingling on her right side on 17Jun2021 1:30. She went to the hospital and they found a DVT blood clot in Jun2021. 1 week later and she had numbness/tingling on both sides. Her knees also started making a tearing sound and were achy in Jun2021. The adverse event DVT blood clot resulted in any of the following doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Treatment received for the adverse event DVT blood clot included Eliquis and no treatment received for the other events. The case was reported as non-serious by reporter. The outcome of the events was not recovered.
36 2021-07-17 fluid around the heart Syncope; Right arm went completely numb; small pericardial effusion; Her right arm lost function and... Read more
Syncope; Right arm went completely numb; small pericardial effusion; Her right arm lost function and went completely flaccid; she could not move it; tingling; soreness was in her muscle where the injection was; muscle pain; soreness in right arm; D dimer: Elevated to 1.14; This is a spontaneous report from a contactable Other Health Professional (patient). A 36-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0191), intramuscular, administered in Deltoid Right on 25Jun2021 15:00 (at age of 36 years old) as single dose for COVID-19 immunisation. Medical history included Rheumatoid arthritis from 2006 ongoing (She was diagnosed at 21. 15 years before 2021. She thinks 2006), compromised immune status, Family Medical History Relevant to AE(s): Mother has a history of stoke. She is only saying that because she had thought she herself had a TIA. That is why she went in because her arm was so numb. Her arm was numb Sunday through Monday. So she thought she better go and get it checked out. Fortunately there was no PE or evidence of stroke or anything. With her mom's medical history she thought she should get it checked out. The patient's concomitant medications were not reported. Prior Vaccinations (within 4 weeks) No, but she had a varicella booster on 21May2021 (at 36 years old). She had to put off her vaccine to make sure she waited the full month before the Pfizer vaccine. No AEs following prior vaccinations. Caller is calling regarding the COVID vaccine. She is reporting an adverse reaction to the first shot which she had on Friday at 3pm. Caller had to go to emergency department last night. She has a small pericardial effusion on 29Jun2021. It was very bizarre. She has never had any kind of adverse reaction to a vaccine before. She is calling because she feels like Pfizer needs to know. After she received the shot everything was fine, she just had soreness in her arm, no big deal. Then Sunday (27Jun2021) she had a syncope event where she almost lost consciousness and simultaneously her right arm went completely numb. Her right arm lost function and went completely flaccid. She had no voluntary control over her right arm. It went completely numb and she could not move it. soreness in right arm: Arm was very sore probably Friday (25Jun2021) and Saturday morning. She took some Ibuprofen and it was completely fine. She no longer felt pain by Saturday (26Jun2021) night. She no longer was feeling any kind of muscle pain from the injection. Caller clarifies that the soreness was in her muscle where the injection was. The muscle pain and soreness are the same thing caller further clarifies. It wasn't anything. It happened. The pericardial effusion was actually last night. It is probably the last one in the order of events. She states she found that out yesterday, actually early this morning. Probably 2am since she was in the Emergency Department forever. This is probably something that will need follow up with an echocardiogram and monitoring and possible medication. It's ok right now but if fluid keeps accumulating it can be lethal and would require a surgery to take the fluid off of the heart. Pericardial effusion is a small amount of fluid that builds up around the heart. The sack that holds your heart muscle, it builds up in-between there. She went to the hospital because of the adverse reactions she was having with the syncope and the numbness in the arm and that is what they discovered. The small pericardial effusion is what her scan found. Caller clarifies that she was not admitted to the hospital. Caller states that the fact that the syncope and numbness in her arm happened together is medically significant. If these things happen on their own it is one thing, but if they happen together that is medically significant that they happen simultaneously. They are less significant on their own than if they happened together. The right arm numbness did not resolve with the syncope. She regained function of her arm but she had numbness and tingling until yesterday. Today it feels much better. Caller states she wanted the Pfizer because that was her pick between that and