Pfizer

Patient had a CVA (stroke) to the R internal capsule and basal ganglia while therapeutic on warfarin. She has a history of Truncus Arteriosus s/p repair and has been anticoagulated for >10 years without issue. Stroke occurred 1 week after vaccine. She now has L sided motor deficits which are likely permanent. Left arm is flaccid. L leg with poor motor function.

Patient became unresponsive within 15 minutes of getting vaccine. Her eyes were wide open, lips were turning blue, and had appeared to stop breathing.

Patient was a 16yr female who received Pfizer vaccine 3/19/21 at vaccine clinic and presented with ongoing CPR to the ED 3/28/21 after cardiac arrest at home. Patient placed on ECMO and imaging revealed bilateral large pulmonary embolism as likely etiology of arrest. Risk factors included oral contraceptive use. Labs have since confirmed absence of Factor V leiden or prothrombin gene mutation. Patient declared dead by neurologic criteria 3/30/21.

lethary and altered mental status 2.5 weeks after COVID vaccine. Found to be septic (hypotension, hypothermia, suspected infection). Admitted to ICU. Required 15L vapotherm for respiratory support and several fluid boluses for blood pressure. Urine culture resulted positive for a bacterial infection. Started on antibiotics and improved. Concern for vaccine adverse event is low.

After the first dose, mild dizziness and nausea followed by massive inflammation in joints and face, severe fatigue and loss of hearing in right ear. Hearing returned in 3 days, general malaise until a week before 2nd shot when she started having severe bloody noses and EXTREMELY heavy period. After the second dose, 45 minute nose bleed soaked through two wash cloths, so many blood clots it clogged the sink.

Stroke; severe allergic reaction; This is a spontaneous report from a contactable consumer (the patient's father) from the Pfizer-sponsored program. A 16-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration, administered in the Right Arm (also reported as: right shoulder) on 23Mar2021 (Batch/Lot Number: ER8732; Expiration Date: 31Jul2021) at 16-years-old as a single dose for COVID-19 immunisation. Medical history included heart valve operation from an unknown date and unknown if ongoing (Mechanical heart valves). Concomitant medications included an unspecified medication, taken for an unspecified indication from an unspecified date to an unspecified date, which was reported as: "Yes she is taking other medication." On 29Mar2021, the patient experienced stroke and severe allergic reaction (medically significant). The clinical course was reported as follows: On behalf of his 16-year-old daughter, the patient's father reported that she had the first dose administer in the right shoulder on 23Mar2021. On 29Mar2021, the patient had a stroke. The patient's father stated, "our lives have changed, completely." The patient's father reported that his daughter was receiving medical care ever since then; and was also being treated by a physician. The patient's father was asking about compensation from Pfizer regarding his daughter's severe adverse event (AE) that occurred after the first dose of vaccine. The patient's father reported that the case had been submitted by the (Name) healthcare team "to the FDA and to Pfizer, and I haven't heard back from either." The patient's father mentioned in passing, that he "could call (Name) and have this all over the news" but that he "wants to be responsible" and doesn't want to do that. The patient's father stated the concern, "Well my concern I am not sure that medical profession is what I really need to do, my concern is that my daughter took the Pfizer COVID vaccine on 23Mar2021 in (Name) in vaccination location. On 29Mar2021, 6 days later, she had a stroke, and that she is receiving a medical care ever since then , now my question is like I said probably for maybe for correlated relation type of person define as well as for it there is a compensation for adverse reaction to COVID vaccination being that this was only thing that was introduce in her system as far as doing that time the vaccination shot." The patient underwent lab tests and procedures which included blood test: "that's for 4/2 out of normal" on an unknown date; also reported: "Yes that's been ongoing as far as giving blood. That's for 4/2 out of normal". Therapeutic measures were not taken and was reported as "no she isn't taking anything for it." The clinical outcome of the events, stroke and severe allergic reaction, was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021411875 Pfizer

16-year-old medically complex female, JIA, bronchiectasis and chronic nighttime oxygen requirement who presented to the hospital on 5/6 with fever, increased stool output, and perianal skin breakdown. Her course was complicated by respiratory failure (requiring ICU admission for CPAP), pancytopenia, diarrhea with buttock skin breakdown requiring rectal tube for wound and stool management, and extensive workup which was unrevealing for an infectious cause. She clinically improved with respect to pancytopenia with discontinuation of felbamate, and completed a treatment course with Zosyn for suspected buttock SSTI.

anaphylactic reaction; anaphylactic shock; vomiting; broke out head to toe in hives; trouble breathing; face swelling; This is a spontaneous report received from a Pfizer-sponsored program, Support received from a contactable consumer (patient's parent). A 16-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, administered in left arm on 08Apr2021 (Batch/Lot number was not reported) as 1st dose, SINGLE dose (at the age of 16 years old) for covid-19 immunisation. Medical history included asthma from 2018 and ongoing (Has been asthmatic about 3 years and has it under control and hasn't had issues in years). The patient's concomitant medications were not reported. Last time at the doctors office was for her well check in Oct or Nov. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 21Apr2021, the patient experienced anaphylactic reaction, anaphylactic shock, vomiting, broke out head to toe in hives, trouble breathing and face swelling. They are not sure if it (anaphylactic reaction) is related to the vaccine. She does not have any allergic issues of any kind and is not sure if it is from the vaccine. The patient has an appointment with an allergist on 05May2021. The pediatrician recommended she wait to get the second dose until after the mother talked to the allergist. She is scheduled for the second dose 30Apr2021. The consumer stated the daughter will miss her second dose tomorrow. The pediatrician told her to wait until speaking to the allergist. If the allergist clears her, it wont be until 05May2021. How long would it be until she can get the second dose. She is not sure if it is related or not. It was 2 weeks after. She ate some kind of granola bar that may have been the cause. Before she called 911 and they gave her epinephrine, it lasted anywhere between maybe up to 15 or 20 minutes. She went to the emergency room (ER) and had to be observed 4 to 5 hours and then went home. Treatment for the events included Epinephrine, steroids and she believes a dose of Pepcid. She was on steroids for like 4 days. The steroid was prednisone. Outcome of anaphylactic shock, vomiting, broke out head to toe in hives, trouble breathing, face swelling were recovered on 21Apr2021. Outcome of anaphylactic reaction was unknown.

Thrombocytopenia noted; Elevated temps to 104; Associated chills; headaches; This is a spontaneous report from a contactable healthcare professional. A 16-year-old non-pregnant female patient received bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE), dose 1 intramuscular on 25Apr2021 (Lot Number: EWO171) as 1st dose, single for covid-19 immunization. Medical history included eczema, Pyle disease, food allergies, short stature, seasonal allergies, peanuts allergies and nuts allergies. It was unknown if the patient was diagnosed with COVID-19 prior to vaccination. The patient's concomitant medications were not reported. The patient did not have other vaccine in four weeks. On 26Apr2021, the patient had elevated temperatures to 104 [unspecified unit], 4-5 days post vaccination (pending clarification) with associated chills and headaches. Thrombocytopenia noted. The adverse events resulted in doctor or other healthcare professional office/clinic visit. No treatment was provided for the adverse events. The patient was tested post vaccination with a nasal swab test on 28Apr2021 and the result of negative. The reporter did not consider the events was serious. The outcome of the event was recovering. No follow-up attempts are needed. No further information is expected.; Sender's Comments: The reported event thrombocytopenia was observed only 1 day after vaccination. It is unlikely that thrombocytopenia is related to BNT162B2. It's more likely intercurrent medical condition. 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.

Immediately after the shot she had a bad headache and approximately 30 to 35 minutes later dizness, chills, and throat restriction (anaphlaxis), extreme muscle soarness( any sort of touch was extremely painful, and she couldn't move her neck, it hurt to move from side to side. Her legs began to feel extremely heavy and hard to move. These symptoms seemed to last for approx 30 minutes. Headache didn't subside until later in the day, it did lighten up.

Presented with acute onset chest pain, found to have right lower extremity DVT and bilateral PEs. Required short stay in ICU for close monitoring given clot burden in her lungs. Required heparin infusion and then transitioned to lovenox for home-going therapy.

Patient presented to the ED with dizziness, fever and heavy vaginal bleeding around 24 hours after receiving her first dose of the Pfizer-BioNTech COVID-19 vaccine. She was tested for active COVID-29 infection via nasal swab PCR and tested positive. Upon presentation labs were drawn and her platelet count was found to be 8 on 5/15. Repeat labs were drawn that day to confirm low platelet count and confirmed diagnosis and thrombocytopenia secondary to an immune reaction to the vaccine was suspected. She was admitted and was started on tranexamic acid, medroxyprogesterone, dexamethasone and IV immunoglobulin (Ig) to help treat low platelet count and vaginal bleeding. As of writing, she is still admitted and her most recent platelet count on 5/17 was 16.

Briefly, patient with history of asthma and food allergies, presenting with hives, nausea, and swelling, in setting of receiving Covid vaccine 36 hours ago. Family had given benadryl and zyrtec without improvement, and symptoms were worsening to presents for evaluation. My exam (after Epipen) showed: Gen: nontoxic appearing; HEENT: no lip/tongue/uvular edema, PERRL, EOMI, normal conjunctiva, neck supple without LAN; Card: RRR, no murmur, good perfusion; Lungs: CTAB, good air entry, no increased WOB, no wheezing; Abd: soft, non-tender, non-distended, no masses; Ext: warm and well perfused, moving all extremities; Skin: hives over hands, arms, abdomen, and legs, including between fingers and on soles of feet Patient presenting with allergic reaction after Covid vaccine, could be more benign allergic reaction such as urticaria multiforme, but given constellation of symptoms and history of severe allergic reaction in past, will treat as anaphylaxis. Therefore given Epipen, steroids, and will plan for observation. Observed 4 hours and continued to be well appearing without symptoms of rebound anaphylaxis. Therefore, patient safe for discharge to home with supportive care and PCP follow up. Given Rx for benadryl and steroids, refilled Epipein. Family in agreement with plan and verbalize understanding of signs and symptoms to return to care. Final Diagnosis 1. Anaphylaxis T80.52XA

Patient vaccinated on 5/28. She reported having pleuritic chest pain and hemoptysis 3 days after that lasted about a week. Then after she developed right leg pain and swelling x 3 days. Seen at our ER 6/11- studies show DVT of the common femoral vein and other veins of the right lower extremity. Also had b/l pulmonary emboli. Started on lovenox treatment and pending thrombectomy by vascular surgeons in 2 days. (In addition she also had admitted to OCP use for a month prior to this event; no reported FH of clotting disorders)

Systemic: Allergic: Anaphylaxis-Mild, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Chest Tightness / Heaviness / Pain-Mild, Additional Details: bp was 105/78 and hr was 85

Admitted to hospital 2 days after second Pfizer covid vaccine. Presented with abdominal/chest pain, found to have a small subsegmental pulmonary embolus on CT scan. No history of prior PE or clots.

~4 weeks after the 2nd dose of Pfizer, patient presented to the hospital with chest pain; had pericardial effusion. Initially improved but then had decompensation, prolonged hospitalization. Diagnosed with hemophagocytic lymphohistocytosis (HLH) and ultimately died.

Blood clots on brain. Needed to be hospitalized for 5 days on blood thinners. Will Continues to self administer blood thinners for 3 more months

L distal internal jugular venous thrombus found on 6/29 after pt had three days of squeezing sensation on upper arm followed by acute pain on day of presentation to ED. In ED upper extremity Doppler demonstrated clot. Pt transferred to our hospital where she started on anticoagulation therapy for treatment.

Patient went to urgent care 1 day after vaccine for feeling tremors and pains in her lower extremities. She also began to feel shaking in her entire body and had lightheadness, shortness or breath, and nausea. She vomited one time. EKG showed Sinus Ventricular Tachycardia/Sinus Tachycardia and was sent to ER by EMS. In ER fluids were given and all further testing normal. Discharged and told symptoms due to dehydration.

She started her menstrual 10 days late with heavy clots and cramps which is abnormal. When she went to her 16 yr old well visit on 7/17 we informed her PCP of the concerns.

Patient presented after syncopal episode and abdominal pain, was found to have profound thrombocytopenia. CT abdomen was done which was concerning for ruptured ovarian cyst. Hgb dropped to 5.8, plts at time of report were 13. Patient transferred to the ICU for further management

patient experienced what appeared to be an anaphylactic reaction immediately after receiving the vaccine. Patient's chest became extremely red and splotchy. Patient's blood pressure was slightly elevated. Patient reported no difficulty breathing and no wheezing was witnessed. The doctor remained in the room with this patient and monitored her until emergency services arrived. Patient refused hospital transfer. Patient was alert and vocal during entire incident. Patients mother was shown how to enroll herself and her daughter in V-safe. Patient will remain in clinic for monitoring and will be followed-up with later this evening and tomorrow morning.

Administered first dose of COVID19 vaccine at 1:29pm on 1/4/21. At approximately 11:00pm resident exhibited acute respiratory decompensation with very limited air entry and hypoxemia. Patient received Benadryl, steroids, epinephrine, and Duoneb without improvement. Resident was referred to the emergency room and found to be COVID positive. No fever or rash were reported.

Systemic: Anaphylaxis-Medium, Systemic: Rash (other than injection site)-Mild, Systemic: Other- wheezing, shortness of breath, coughing-Medium

Fever of 103 F, received Tylenol, then developed tonic-clonic seizure activity for about 20 minutes (received 10mg intranasal midazolam and 0.5mg buccal clonazepam while awaiting EMS)

About 20 minutes after receiving the shot I got drowsy. About 30 minutes to an hour later I started having mild stomach cramps similar to menstrual cramps. I later found out I had menstrual bleeding (about 2:30 PM). This was unnatural for me because I have an IUD and have had it for 9 months, so I haven't been getting PMS like cramps or my cycle for the past few months.

Anaphylaxis (hives, oropharyngeal swelling, cough, shortness of breath) 20 mins following vaccine administration. Patient given epinephrine at vaccine site 20min after symptom onset with significant improvement in symptoms including improved pharyngeal swelling and resolution of hives. Patient presented to the emergency department 1.5 hours following onset of anaphylaxis with mild cough and mild pharyngeal swelling for observation.

Patient had anaphylaxis with recorded trigger (Pfizer COVID vaccine). She received epinephrine onsite, and then an additional dose of 0.3mg in ED. She however, required required two more doses of 0.5mg epinephrine and racemic epi neb. She was admitted for further observation given need for multiple doses of epinephrine. At approximately 9:00 am (~18 hours post vaccine) a rapid response was called on 4/13 and patient was transferred to the PICU for further treatment. Patient also received the last dose of epinephrine 0.5mg at approximately 9:00 am (~18 hours post vaccine). Patient received famotidine 20mg IV x1 and methylprednisolone 90mg IV x2 in the PICU. Patient was discharged on 4/14 at 8:00 am from the PICU, approximately 41 hours post vaccine administration. Received a total of epinephrine x7 doses during the hospitalization.

left-side facial drop with left mouth corner; stroke symptoms; transient mild headache; blurry vision; left side of tongue affected; slurring speech; felt confused; drowsy; This is a spontaneous report from a contactable consumer (patient). This 17-year-old female patient received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8734), via an unspecified route of administration in the right arm at 17 years old on 30Mar2021 at single dose for COVID-19 immunization. Medical history included acquired brain injury (C-PVL) from pneumococcal strep infection, hypoxic ischemic encephalopathy, premature birth, quadriplegic dyskinetic cerebral palsy. Concomitant medications were none. The patient was not pregnant at time of vaccination. The patient previously received T-Dap vaccine at 10 years old and had prolonged migraine reaction. 12 days after, the patient developed stroke symptoms with transient mild headache, blurry vision, and left-side facial drop with left mouth corner and left side of tongue affected causing slurring speech also felt confused and drowsy which lasted for 8 hours. Events were started on 11Apr2021 at 03:30 PM. Events resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient went to ER, they did stroke work-up. No evidence of stroke. The patient received treatment including CT scan, MRI, EKG, labs. The patient had no covid prior vaccination, no covid tested post vaccination. Outcome of the events was recovering.

Patient received first COVID19 Pfizer vaccine on 4/18. At that time, had about 3 days of cough and chest tightness. Subsequently began having neck pain on 5/8 and received second Pfizer vaccine on 5/9. Then began having fevers (Tmax 103F), cough. Admitted to Hospital on 5/15 with respiratory failure and shock. Unclear etiology of pneumonia vs multisystem inflammatory syndrome in children (MIS-C). Did not initially respond to antibiotics so treatment for MIS-C was initiated. Now slowly improving but still hospitalized.

on 5/14 developed severe bilateral pulmonary embolism with severe right ventricular hypertension and heart failure. Progressed to cardiac arrest requiring mechanical circulatory support (ECMO) in PICU. Managed in the Cardiac ICU

- Pain/tenderness at injection sight for ~72hrs after vaccination -Small red bump (size of quart) at injection site( was gone after 72hrs.) ***- Abnormal vaginal bleeding, heavy bleeding occured, o clots within blood, cramping*** - General malaise

Initially developed hives then swelling of lips, face and difficulty breathing with cough (anaphylaxis reaction). Treated by school nurse with epipen then ambulance paramedics arrived and administered nebulizer treatment, IM benedryl, dexamethasone and transported to ER for follow up stabilization. ER administered additional antihistamine. Patient was discharged from ER stable and in much improved condition.

Systemic: Fainting / Unresponsive-Medium, Additional Details: Pt fainted after vaccine, hit head on nearby object. sustained approx 2 cm laceration to scalp with moderate bleeding. applied saline wound wash and gauze. bleeding stopped. VS normal BP110/72, P90,RR14,O297%RA. Pt revived after1-2 min. She sat up and was able to walk. Mom at work. Mom called neighbor to pick up pt. Mom agreed to have FM take pt to ER/urgent care.

Multisystem Inflammatory Response to the vaccine with fever for 5 days, elevated LFT's, low Na, low platelets, elevated CPK. Patient hospitalized for 2 days.

Fever; Joint pain; facial and tongue swelling/broken out in a rash broken out in a rash that moved to her face and lips/anaphylaxis/daughter's eye started to swell; Serum sickness; elevated CRP; Hives/an allergic reaction/lip and face swelling; This is a spontaneous report from a contactable consumer (the mother) reported for her daughter. A 17-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via intramuscular, administered in left arm on 02Apr2021 10:00 (Batch/Lot Number: EN6207) as 2ND DOSE, SINGLE for covid-19 immunisation. Medical history included Colitis ulcerative from 2014 and ongoing, Genetic immune deficiency, additional Information for other conditions: Caller describes it as "22q". patient was born with this but wasn't actually diagnosed until patient was 11 years old. They checked with patient's Immunologist before getting the vaccine especially with her daughter's history. Thyroid disease from 2015 to an unknown date, additional Information for other conditions: patient didn't have a thyroid- her thyroid was removed. Concomitant medications included cetirizine; famotidine; montelukast sodium (SINGULAIR); and epinephrine (EPIPEN) all taken for an unspecified indication, start and stop date were not reported; aloe vera, pramocaine hydrochloride (ATARAX ANTI ITCH LOTION) taken for itching, swelling and hives, start and stop date were not reported. The patient took first dose of Pfizer COVID vaccine on 12Mar2021 10:00 (Lot: EN6207) for COVID-19 immunization and patient had no side effects after the first dose. No additional vaccines administered on same date of the Pfizer suspect. No prior vaccinations (within 4 weeks). The patient just saw her Immunologist and her Immunologist instructed her to report what is going on with patient. Caller clarifies patient's immunologist plans to call and report as well but also instructed her to call and report the side effects her daughter is experiencing. Her daughter was cleared to have the COVID vaccine. The caller explains they always check with her immunologist because of her daughter's immune issues. Her daughter received the second dose of the COVID vaccine on 02Apr2021. On the evening of 04Apr2021, her daughter broke out in hives. They didn't think it was a big deal, they thought it was just an allergic reaction. She tried Benadryl and several other things. They went and saw her daughters regular general practitioner and the doctor believed it was just a delayed skin reaction, which seems to be common with the Pfizer COVID vaccine. The doctor told her he's seen one other person with this delayed reaction. He gave her daughter a steroid injection, a Steroid Dose Pack and Pepcid. She was also placed on Benadryl as needed. About 2 weeks after this, her daughter and lip and face swelling and ended up in the Emergency Room (ER). At this ER visit, they initiated the allergic reaction protocol and it was not an anaphylactic reaction at that point. Her daughter received IV Benadryl and IV steroids, the caller is not sure what else. She confirms she has no NDC, Lot number and expiry dates for the medication her daughter received in the ER. The ER doctor contacted the Immunologist on call and the Immunologist had seen a few cases with a delayed reaction. Caller clarifies the ER doctor discussed her daughter's delayed skin reaction with the on-call Immunologist. The oncologist put her daughter on generic Zyrtec, 20mg in the morning and 20mg at night. The following week, her daughter woke her up with facial and tongue swelling. She clarifies further her daughter had fever, joint pain, and had broken out in a rash that moved to her face and lips. She immediately took her to the ER. The ER followed the whole anaphylaxis protocol and was given an EpiPen. She explains her daughter was diagnosed serum/covid sickness. This has been going on for over 6 weeks. The reaction will come and go. She was told as her daughter's body develops immunity, she is basically allergic to it. She clarifies at her ER visits, they checked her daughters liver and kidneys. It was noted her daughter had and elevated CRP, which is an inflammatory marker. The caller was told they thought her daughter had serum sickness from the vaccine which may last 4-6 weeks or it may be prolonged, so they just went with it. They told her as long as it didn't move to her lips or affect her daughters breathings, eventually it would wax and wane and go away. Her daughter started breaking out on her arms and legs and last Saturday, she woke up and her face was swelling. She clarifies her daughter's eye started to swell and her tongue. She took her straight to the ER and the ER followed the anaphylaxis protocol and injected her with an EpiPen. They contacted her Immunologist to check and make sure it wasn't anything else and consulted with the Covid Vaccine Clinic and it was found 3 other patients had this happen. No further details were provided regarding the 3 other patients. Right now, her daughter is on 4 different medications and an EpiPen. They contacted her insurance about her being placed on a biologic because not even the current medications her daughter is on is making everything going away. Caller verifies her daughter was never admitted into the hospital. When she was last seen in the ER Monday, she her daughter was monitored for 4 hours after the EpiPen was administered. The events require a visit to Emergency Room (total of three ER visits) and Physician Office. She known the last/third ER visit was Monday, 17May2021. The second ER visit was 04May2021. She believes the initial/first ER visit was probably a week or so before the second one. She clarifies she broke out in hives on 04 Apr2021 and went to the doctor on 07Apr2021 or 08Apr2021 so the ER visit was around the next week. Since her daughter had such a good response from the EpiPen the ER doctor took pictures before and after. She clarifies the name of the biologic they want to put her daughter on is Xolair, it is a monthly injection. She explains the current cocktail they have her daughter on is not working. She provides the following product information for these 4 medications and EpiPen. Relevant Tests included she knows they are testing for any other thing that it could be to rule it out. She knows they ran a CIS-tray, a complete CIQ , a Histamine release something and Tryptase. She knows they checked her CRP (inflammatory marker) because it was elevated. Every time her daughter went to the ER, they did a CBC and all of that was normal except for the CRP inflammatory marker, however her CRP was normal at the last ER visit. The outcome of events was unknown. No follow-up attempts are needed. No further information is expected.

on 05/28/2021 at 0815 patient experienced tonic-clonic grand mal seizure lasting approximately 1 minute. A second tonic-clonic grand mal seizure lasting approx 1 minute was also experienced and witnessed in pt's home on 06/02/2021. Second grand mal resulted in hospitalization of pt overnight and adjustment of AED's was made. Prior to these seizures pt had been seizure free for 3 months.

received the first dose of the Pfizer COVID-19 vaccine and also recently started taking Depo-Provera. After receiving the first dose of the Pfizer COVID-19 vaccine her daughter developed a blood clot; tired and frail; feels lost and light headed; cramping pain; This is a spontaneous report from a contactable consumer (Patient's mother). A 17-year-old female patient received first dose of BNT162B2 (BNT162B2) via an unspecified route of administration, administered in Arm Right on 03May2021 15:00 (Batch/Lot number was not reported) as 1ST DOSE SINGLE for covid-19 immunization and medroxyprogesterone acetate (DEPO-PROVERA), route of administration, start and stop date, batch/lot number and dose were not reported for contraception. The patient's medical history and concomitant medications were not reported. The patient experienced received the first dose of the pfizer covid-19 vaccine and also recently started taking depo-provera. after receiving the first dose of the pfizer covid-19 vaccine her daughter developed a blood clot, tired and frail, feels lost and light headed and had cramping pain all on unspecified dates. It was reported that after receiving the first dose of the Pfizer COVID-19 vaccine her daughter developed a blood clot. Her daughter, who is currently on Depo Provera got her first dose of the Covid 19 vaccine. The daughter has been experiencing blood clotting and would like to further document this experience. Is also seeking medical advice to inform her daughter. Her daughter Has been on Depo Provera for 4 to 5 months. Since she had the Covid vaccine, she has been having bad blood clotting and has been having a continuous period. When she got the shot, she has been getting blood clots straight for three weeks. Patient is Tired and frail: She is a waitress, so all of this has made it hard. It started right when she got the shot and has pretty much stayed the same. She will feel like she is lost when she wakes up and is light headed from the loss of blood. It occurs when she is doing activities, like working. Patient took some Midol one day for cramping pain but it barely did anything. The action taken for medroxyprogesterone acetate was unknown. Outcome of tired and frail was not recovered. Outcome of all the other events was unknown. Information on Lot/Batch number was not available. Additional information has been requested.

Patient had massive acute intracranial hemorrhage. Was found down in bathroom. In ED CT scan showed large intraventricular hemorrhage, EVD placed, patient progressed to massive brain swelling and infarctions, decompressive craniectomy, unable to control intracranial pressure, parents agreed to DNR status and patient is not expected to survive.

Patient with significant right leg DVT requiring thrombolysis by vascular surgery. She will need to continue on anticoaggulants outpatient.

The patient had an apparently spontaneous anaphylactic type reaction with facial hives, eye redness and swelling, diffuse hives on trunk, lips, and extremities, tongue swelling, difficulty swallowing, and itchy tongue. The only thing had had had to eat or drink was a cows milk latte with hazelnut 2 hours prior to the reaction. No fever. The family gave her 2 tabs of Benadryl (50 mg total) at home and brought her to urgent care whereupon her hives and tongue swelling had decreased substantially. They showed photos of her face and skin prior to the Benadryl. She was given 60 mg prednisolone and observed for over 30 minutes. She improved substantially and was discharged home with her mother pending results of allergy testing.

Intermittent vaginal bleeding - spotting. Has been on norethindrone acetate 10 mg daily for over a year with no spotting

Presented to the Medical Center with concern for seizure activity, found to have atrial fibrillation in emergency department. Echocardiogram performed, and found to have moderately dilated left atrium and moderate mitral valve insufficiency. Initiated metoprolol for heart rate control, levetiracetam for possible seizure, and rivaroxaban to prevent cardiac thrombosis.

First vaccine 3/24/21 Second vaccine 4/14/21 In early may, mom can't remember date, patient c/o left leg and foot pain. Went to podiatrist - no diagnosis made - was told to monitor. Mid to late May developed dry cough. Not seen for this. On June 10 taken to ED lower left leg extremely painful and swollen and mom reported discoloration to back of leg. Diagnosed with DVT and put on blood thinner Xeralto and discharged. A week later went to hematologist who said to continue Xeralto and monitor. A week after seeing Dr. and two weeks after initial ED visit, on a Wednesday, patient started to cough up blood. Went back to Dr. and patient was taken off of Xeralto. PE scan ordered. The next day patient developed chest pain and went to ED. PE scan done and diagnosed with two PE's on right lung. Was informed had six blood clots in lower left leg. Admitted to ICU. Was an inpatient for 5 days then discharged. Now patient is taking Lovenox injections twice daily.

menstrual cycle came which lasted 8-10 days of heavy bleeding; experianced spotting; This is a spontaneous report from a contactable consumer (mother). A 17-years-old female patient received BNT162B2 (BNT162B2, solution for injection, batch/lot number: EW0164, expiration date: Aug2021) dose 1 via an unspecified route of administration, administered in Deltoid Left on 24Apr2021 as DOSE 1, SINGLE for COVID-19 immunisation (at the age of 17-years-old). The patient's medical history included nuts allergy and muscle spasms from an unknown date and unknown if ongoing Concomitant medication included ascorbic acid (C-VITAMIN) taken for an unspecified indication, start and stop date were not reported, chlorophyll (CHLOROPHYLL) taken for an unspecified indication, start and stop date were not reported. after the first dose her daughter experienced spotting (on 25Apr2021) for 4 days and then her menstrual cycle came which lasted 8-10 days of heavy bleeding (30Apr2021). it was so excessive bleeding that patient had to change pads a lot. Caller stated it has slowed down since yesterday. The patient usually only spots the day before she gets her period. When the patient came on her cycle, she bled heavy and could not go to work and was changing her pad every 1-2 hours. The caller had the patient take an iron pill. The patient's period finally eased up on day 10 and started slowing down. Today, 13May2021 the patient only had to change her pad once. The patient's second dose is due the 20May2021. The outcome of event spotting was unknown, whereas the event heavy bleeding was recovering. No follow-up attempts are possible. No further information was expected.

Pt presented by EMS for acute epigastric pain radiating to the back. While waiting for lab results, she was found down in her room and in post-ictal state. She was moved from an urgent care room to an ER bed and returned to near baseline when she had witnessed seizure activity and subsequently required multiple medications to break her status that lasted around 30 minutes

Patient developed urticarial rash on 3/13/21 which began on her lower extremities and progressed to most of her body by the following day. She was seen on 3/15/21, and had no other symptoms besides the rash and was treated with zyrtec and benadryl but prescribed an Epipen (Auvi-Q) in case of worsening. The next day, 3/16/21 she awoke with swelling in her mouth and worse rash, used her Auvi-Q and called 911 and was taken to ER where she was treated for anaphylaxis with IV solumedrol,, IV fluids and IV benadryl and was sent home on Prednisone and benadryl and Pepcid.

48 hours after the vaccine, patient had a drop in glucose down to 40 which triggered grand mal seizure. Admitted to the hospital for 2 days, thought it was possibly due to UTI, however because of how soon it was to the vaccine I wanted to report it just in case it were linked.

Acute DVT in left LE. Patient presented to ED on 3/22/21. She had 2 day h/o leg discomfort and leg was taught and painful on the day she went to the ED. Study was limited due to pt lack of cooperation. Lovenox started.

PT RECEIVED SHOT, SAT ON CHAIR FOR 5 MINUTES. PT STATES SHE DOESN'T FEEL GOOD AND SLOWLY FELL OUT OF HER CHAIR. I WAS ABLED TO CATCH HER IN TIME AND LAY HER DOWN ON THE GROUND. PT LOST CONSCIOUSNESS AND STOPPED BREATHING. WAS ABOUT TO PERFORM CPR BUT PT WOKE UP BY HERSELF AND ACTED NORMAL AGAIN.

Patient had anaphylaxis reaction. Tongue swelling, SOB, rash, Given benadryl. Taken to ED for observation. Epi pen, benadryl, pepcid, and solumedrol administered.

Pt and father moved into the waiting area with vehicle. According to dad, pt began seizing in the car one minute after the vaccine administration. Dad called out to waiting area Monitor. Monitor called for help. LT and SPC appeared on scene. 1257 Pt was visibly having tonic clonic seizure. SPC administered EpiPen in Right Leg. 911 was called. Pt stopped seizing and was awake and confused. She then became AOx4. Pt visibly distressed and hyperventilating. 1259 Pt had tonic clonic movements and seizure again. Seizure last less than 15 seconds. Pt then became AOx4 again, distressed, and became nauseous. HR 56 SpO2 98% 1300 Pt vomited while sitting up. Still distressed and hyperventilating. RR 30. Post vomiting HR 116, SpO2 97%. Pt moved to stretcher and moved to shade. 1306 Firefighters arrived. HR 114 BP 141/46 SpO2 97% RR 24 AOx4 1312 Ambulance arrived. 1320 Pt left for medical center.

bleeding; less soreness at the injection site; This is a spontaneous report from a contactable consumer. An 18-year-old female patient (non-pregnant) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8735, expiration date: unknown), via an unspecified route of administration administrated on left arm on 05Apr2021 at 16:00 at the age of 18-year-old at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. No other medications in two weeks. The patient did not have any known allergies. She received first dose of BNT162B2 (Pfizer Covid-19 vaccine, Lot number: EN6204, Expiry date: unknown) via an unspecified route of administration, administrated on left arm on 14Mar2021 at 15:00 (03:00 PM) at the age of 18-year-old at a single dose for COVID-19 immunization. On 05Apr2021 04:00 PM, reported that the 2nd dose of vaccine caused unusual amount of bleeding after needle was removed. The patient had to clean excess blood after the shot. The band aid was soaked with blood. The patient experienced less soreness at the injection site compared to the first vaccine shot. The concern is whether the vaccine was bled out due improper injection. She did not have any other vaccine in four weeks before the covid-19 vaccine dose. The patient did not receive any treatment for the events. She was not having COVID prior to the vaccination, neither was tested for Covid-19 post vaccination. The patient recovered from the events on an unspecified date in 2021.

vomited; nauseous; visibly distressed; hyperventilating; began seizing/visibly having tonic clonic seizure; HR 116/ HR 114; HR 56; RR 30; BP of 141/46; This is a spontaneous report from a contactable nurse. An 18-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EW0170), intramuscular, administered in the right arm on 20Apr2021 at 12:45 as a single dose for COVID-19 immunization. Medical history included anxiety from an unknown date and unknown if ongoing. Concomitant medications included fluoxetine hydrochloride (PROZAC) taken for an unspecified indication, start and stop date were not reported. The patient did not have COVID prior to the vaccination. The patient did not receive other vaccines in four weeks. The patient had not been tested for COVID post vaccination. On 20Apr2021 at 12:45, the patient and her father moved into the waiting area with vehicle. According to the patient's dad, the patient began seizing in the car one minute after the vaccine administration. The dad called out to waiting area monitor. At 12:57 the patient was visibly having tonic clonic seizure and was administered with EpiPen in the right Leg. 911 was called. The patient stopped seizing and was awake and confused. She then became AOx4 (oriented to four spheres; time/place/person/situation). The patient visibly distressed and hyperventilating. At 12:59 the patient had tonic clonic movements and seizure again. The seizure lasted less than 15 seconds. The patient then became AOx4 again, distressed, and became nauseous. Heart rate (HR) was 56 and SpO2 was 98%. At 13:00 the patient vomited while sitting up. The patient was still distressed and hyperventilating with respiratory rate (RR) of 30. The patient's post vomiting HR was 116 and SpO2 was 97%. The patient moved to a stretcher and moved to the shade. At 13:06 firefighters arrived and the patient had an HR of 114, BP of 141/46, SpO2 of 97%, RR 24 and AOx4. At 13:12 the ambulance arrived and the patient was taken to (Place). The events resulted in a visit to the Emergency room/department or urgent care. The outcome of the events was unknown.; Sender's Comments: Based on the available information, and on close temporal association, a reasonable possibility cannot be excluded that the suspect drug BNT162B2 (Pfizer-BioNTech COVID-19 vaccine) contributed to the occurrence of the serious event Generalised tonic-clonic seizure. 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.

Patient received her 1st Covid vaccine today, with a known history of anaphylaxis to the flu shot 6 months prior. She was assigned a 30 minute wait time. She received her vaccine at 1225 on 14May2021, and approximately 15 minutes later developed itchiness around her mouth and face. She reported this felt similar to the beginning of her prior episode. Physician and nurse were notified, who evaluated patient. Patient?s airway was clear, respirations unlabored and normal to auscultation. Vitals were within normal limits. EMS was notified, and 50mg Benadryl was given at 1255. At this time patient?s reaction appeared minor and stable, so epipen was at patient?s side however not given yet. EMS arrived rapidly, and repeated eval, confirming same evaluation and history. Patient was transferred in stable condition to the ER for extended monitoring.

18 year old female suffered a heart attack/swelling of the sack around the heart die to the second Pfizer vaccine. Spent two days in the hospital/cardiac wing. She is still being monitored by doctor to this day.

The evening after receiving the vaccine, pt began having headache, lightheadedness, shortness of breath, nausea, loss of appetite. Th next day (6/10) she notedmyalgias in lower back and hips with shooting pains in her knees and vomiting. She also noted mild fever and chills, nasal congestion and discharge with mild sore throat, and substernal chest discomfort. She described it as tightness with radiation to her throat and jaw, and right arm, witout radiation to her back, not associated with nausea, but is associated with shortness of breath and diaphoresis. Chest discomfort worse with lying down. Rapid COVID test negative. Upon arrival to ED on 6/11, her troponin was mildly elevated (0.039ug/L), D-dimer elevated at 348ng/mL, CRP also elevated at 5.96 mg/dL. ED physician diagnoses acute myopericarditis and patient was admitted to Critical Care Unit. On 6/13/2021 patient was discharged stable (limited bedside echo showed small pericardial effusion). Pt denies pleuritic chest pain on day of discharge.

I started experiencing pain in my calf on 4/21 that same night of the vaccination. There was a tight feeling in my knee and every time I took a step with my right leg there was pain that radiated down my calf. It almost felt like a muscle pain so I ignored it for a few days. By 4/24 the pain had gotten so bad that I didn't want to walk anywhere and cried when I walked. My mom came and picked me up and took me to the urgent care center. They asked me a few questions and told me that I needed to go to the ER to get checked for a blood clot. I went to hospital on 4/24, and an ultrasound of my knee was done. The doctor diagnosed me with a blood clot and told me to stop taking the Xulane which was my birth control at the time. They told me to follow up with my OBGYN and a hematologist. (I had been on my birth control for about 6 months and I have never had any issues with blood clots and they do not run in my family. The NP is who told me to report my blood clot to the CDC because she is a little suspicious that the shot is where it come from.)

Flare of underlying Evans Syndrome, with onset of severe thrombocytopenia occurred 2 weeks and 6 days after the first injection.

A doctors office visit on 4/28. Discussed the symptoms (minimal change disease-like symptoms, possible nephrotic syndrome, possible acute kidney injury, possible blood clots).; A doctors office visit on 4/28. Discussed the symptoms (minimal change disease-like symptoms, possible nephrotic syndrome, possible acute kidney injury, possible blood clots).; A doctor's office visit on 4/28. Discussed the symptoms (minimal change disease-like symptoms, possible nephrotic syndrome, possible acute kidney injury, possible blood clots).; no facilitated urination; Severe swelling on both legs with sudden body weight increase (over 10 lbs) after about a week of second dose; Severe swelling on both legs with sudden body weight increase (over 10 lbs) after about a week of second dose; This is a spontaneous report form a contactable consumer (patient) reported for herself. A 18-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Solution for injection Batch/Lot Number: EW0158) via an unspecified route of administration in arm right on 18Apr2021 as dose 2, single for covid-19 immunisation. Medical history included none history. Concomitant medications include levocetirizine (LEVOCETIRIZINE Batch/Lot number was not reported) via an unspecified route of administration from an unspecified date, at 5 mg for an unspecified indication. Historical vaccine includes bnt162b2 (Dose 1 lot number=EP7534 vaccine location=Right arm) on 26Mar2021 for COVID-19 immunization. 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 has not been tested for COVID-19. On 23Apr2021, the patient experienced a doctors office visit on 28Apr. Discussed the symptoms (minimal change disease-like symptoms, possible nephrotic syndrome, possible acute kidney injury, possible blood clots). Started to take 20mg furosemide for 7 days from 28Apr and 20mg prednisone for 10 days and 20mg furosemide on 04May. Even after finishing medication, there were no changes in symptoms. Continued leg swelling and no facilitated urination. There was severe swelling on both legs with sudden body weight increase (over 10 lbs) after about a week of second dose. After finishing both, the swelling in legs subsided and weight returned to normal. About 10 days later, moderate swelling in legs returned and body weight increased by about 5 lbs. The patient visited nephrologist visit on 02Jun and was prescribed 20mg prednisone, 3 tablets every other am for 20 days. Currently, patient have been taking the medicine since 03Jun. As of now 12Jun2021, the leg swelling partially decreased and the body weight decreased by 1-1.5 lbs. The clinical outcome of all the events was not resolved.

Intense vaginal bleeding two days after that lasted a week, before this it had been a year and a half since last cycle due to being on hormone replacement therapy. From June 16th to June 23rd.

Acute right posterior cerebral artery stroke, symptoms (headache, vision change) started 06/26/2021, patient sought medical attention and diagnosed 06/28/2021

Extreme bleeding; Cramping; Tightness in chest; This is a spontaneous report from a contactable consumer or other non hcp (patient). An 18-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration, administered in arm left on 23Jun2021 (at the age of 18-year-old) at dose 1, single for covid-19 immunisation. Medical history included acne. Family medical history relevant to adverse event was none. Patient did not administer additional vaccines on same date of the Pfizer Suspect. History of all previous immunization with the Pfizer vaccine was not considered as suspect. Patient did not have adverse event following prior vaccinations. Patient did not have prior vaccinations within 4 weeks. Concomitant medication included trimethoprim (TRIMETHOPRIM) at 100mg taken for acne from an unspecified date in Dec2019 and ongoing (Trimethoprim: Patient has been taking this medication for over a year and never had any issues with it. She started it and stopped it and then they had her start it again. It has been sporadic based on her acne). The patient experienced extreme bleeding, cramping, tightness in chest on 24Jun2021 08:00. Patient had an adverse reaction. Patient stated that she had extreme bleeding, cramping and tightness in her chest. Another person came on the line and stated that patient had these symptoms last night and was on the way to the doctor now. Clarified with patient that she was on the way to the hospital. Did not think patient will be receiving the second shot. That person stated that the date of onset of the adverse events was last night, but patient clarified onset date for each event as 24Jun2021. Relevant tests were none. Outcome of the events was not resolved. Information about lot/batch number has been requested.

19 y.o. female who arrived to the emergency department for 19-year-old female with history of COVID infection several months ago was receiving her COVID vaccine this morning when she developed nausea and tightness in her throat about 15 minutes after the injection. Epinephrine was administered prior to transfer to the ED. She denies any rash. She does feel slight shortness of breath. She denies headache earache sore throat or rhinorrhea cough vomiting diarrhea fever chills or abdominal pain. She has had hives and tightness in her throat from several medications in the past including Prevacid Prilosec Zantac and iodinated contrast media. No new medications. Anaphylactic type reaction and patient advised to not receive the 2nd vaccine. PMH: Diabetes mellitus Initial Vital Signs Blood Pressure 01/25/21 0902 132/85 Heart Rate 01/25/21 0902 92 Respiratory Rate 01/25/21 0902 16 Temp 01/25/21 0925 36.6 °C (97.9 °F) Temp Source 01/25/21 0925 Oral SpO2 01/25/21 0902 99 %

Anaphylactic reaction; Throat was swollen shut, couldn't talk or breathe; Throat was swollen shut, couldn't talk or breathe; Throat was swollen shut, couldn't talk or breathe; loss of consciousness; brain fog; headache; fever; severe body aches and joint aches that make movement difficult; severe body aches and joint aches that make movement difficult; severe body aches and joint aches that make movement difficult; persistent chest pain/pressure; low blood pressure; some swollen and tender bilateral lymph nodes in my neck/trapezius/left (injection site) axillary region; fatigue; decreased appetite due to nausea; decreased appetite due to nausea; This is a spontaneous report from a contactable healthcare professional. A 19-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at the left arm on 25Jan2021 08:45 at a single dose for COVID-19 immunization at a hospital. Medical history included type 1 diabetes mellitus, Celiac disease, COVID-19, and heartburn. Concomitant medication included insulin lispro (HUMALOG), spironolactone, fluvoxamine, and alprazolam (XANAX XR). The patient previously took gluten, magnesium ,and iodine and experienced allergies. On 25Jan2021 09:00, patient had an anaphylactic reaction. Throat was swollen shut, couldn't talk or breathe, loss of consciousness, brain fog, headache, fever, severe body aches and joint aches that make movement difficult, persistent chest pain/pressure, low blood pressure, and some swollen and tender bilateral lymph nodes in my neck/trapezius/left (injection site) axillary region, fatigue, and decreased appetite due to nausea. Patient had a doctor or healthcare professional visit, went to emergency room/department or urgent care, and was considered life threatening illness (immediate risk of death from the event). Events was treated with epinephrine, diphenhydramine (BENADRYL), paracetamol (TYLENOL) and had oxygen. Patient was not tested post vaccination. The patient is not pregnant. The patient has not recovered from the events.; Sender's Comments: There is a plausible time relationship between vaccine administration and onset of the events in a subject with allergic diathesis. 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.

Bells Pals half of face, numbness, weakness, headache, fever, diarrhea, nausea, chills, body aches, fatigue., tics and then a few days later had a gran mal seizure, forgetfulness

I DON'T KNOW THE EXACT EVENTS FOR THE CASE, BUT WAS ASKED TO FILL IN THE INFORMATION THE BEST I COULD WITH THE INFORMATION I HAD ON HAND. THIS YOUNG LADY, RECEIVED A COVID-19 VACCINE ON 3/6/2021 AND EXPIRED ON MARCH 13, 2021. THIS IS MOST OF THE INFORMATION THAT I HAVE. YOU WOULD NEED TO CONTACT THE MEDICAL EXAMINER'S OFFICE, THAT WILL BE ABEL TO PROVIDE YOU WITH MOST DETAIL FOR THIS CASE.

Thrombocytopenia, bruising within a week of vaccine. Patient was admitted for 48 hours and discharged. Plan is for her to follow up with PCP and have a CBC rechecked.

strange pain on her left collar bone; going to see someone just in case it's a blood clot; lump on her collar bone, left collar bone; does hurt a little bit; This is a spontaneous report from a contactable consumer or other non hcp (patient herself). A 19-years-old female patient received bnt162b2 (BNT162B2, Formulation: Solution for injection), dose 1 intramuscularly administered in Arm Left (like the shoulder area) on 28Mar2021 09:00 (Lot Number: ER8734 and Expiry date: unknown) as single dose for covid-19 immunisation. The patient medical history was not reported. There were no concomitant medications. No additional Vaccines administered on same date of the Pfizer suspect. On 30Mar2021, the patient experienced going to see someone just in case it's a blood clot, lump on her collar bone, left collar bone, does hurt a little bit and on unspecified date strange pain on her left collar bone. 19-year-old female got the first Pfizer Covid vaccine at 9 am on Sunday, March 28 and this morning, she woke up with a strange pain on her left collar bone and there was a lump there, states when she woke up, she noticed a pain, checked in the mirror, she saw on the left side she saw a bump and checked on the right side and didn't see anything and that's when she got worried. Caller states she was just calling to report it, she's worried that it's a blood clot or something else. Why was the patient taking Pfizer BioNTech COVID Vaccine (Verbatim): she wanted to be vaccinated to protect herself and her community. Caller states she would not like to provide her last name at this time. However, provided her last name initial. She also reports she would not like to provide her address, height, or weight right now. She states she used to volunteer at a hospital. She does not see expiration or NDC number on card she received when she got her vaccine. Caller states she does know that one of her family members has the Factor 5. She is not sure if she has it but would like to be tested for it. The outcome of the event going to see someone just in case it's a blood clot was recovered, lump on her collar bone, left collar bone and does hurt a little bit was not recovered and strange pain on her left collar bone was unknown. Information on batch/Lot number has been requested.

This is a spontaneous report from a contactable consumer (patient). An 19-year-old female patient (not pregnant at event onset and time of vaccination) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number and expiration date unknown) via an unspecified route of administration at left arm on 11Feb2021 at 00:00 (19-year-old at time of vaccination), at single dose, for COVID-19 immunization. The patient's medical history included Ewing Sarcoma which was not ongoing (Diagnosed at 5 years old, treated with chemotherapy for 1 year, cancer free for 13 years). There were no known allergies. Concomitant medications included low dose ethinylestradiol, norgestimate (TRI-SPRINTEC) and montelukast sodium (SINGULAIR). No other vaccine in four weeks. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number and expiration date unknown) via an unspecified route of administration at left arm on 20Jan2021 at 00:00 (19-year-old at time of vaccination), at single dose, for COVID-19 immunization. Starting 15Feb2021 at 12:00, the patient began to have shortness of breath that got progressively worse throughout the week. On 22Feb2021, she woke up with severe shortness of breath and her O2 saturation was 82%. She went to the hospital emergency department and was given a chest CT, and diagnosed with large bilateral pulmonary embolisms. She also had severe right ventricular strain due to the PEs. She was rushed into an EKOS procedure and a IVC filter was also put in. Adverse events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization (4 days), and Life threatening illness (immediate risk of death from the event). COVID test (test type: Nasal Swab, test name: Novel Coronavirus PCR) post vaccination was Negative on 22Feb2021, and Negative on 29Mar2021. Therapeutic measures were taken as a result of the events and included Heparin drip, EKOS and IVC filter procedure. The outcome of the events was recovering. Information on the lot/batch number has been requested.

Patient transferred from medical group practice for b/l PE. Patient reports chest pain and SOB x 4 days ago. Patient has also been having hemoptysis for the past couple days as well. Physical exam is remarkable for tachycardic heart rate and rhythm is regular. Patient given heparin bolus and infusion and admitted to hospital for acute large main vessel pulmonary embolism. 2D echocardiogram showing no signs of right heart strain. Patient was transitioned to oral Eliquis and given a 1 month supply on discharge. Patient told to stop birth control and avoid NSAIDS. Patient instructed to F/U with PCP and hematology.

Experienced life-threatening blood clots in both lungs (bilateral pulmonary embolism); chills; flu-like symptoms; difficulty breathing; chest pain; nerve pain in neck; severe rib pain; spitting up blood constantly; severe aches and pains all over my body; This is a spontaneous report from a contactable consumer. A 19-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 08Apr2021 15:45 (Batch/Lot Number: ER8737) (at age of 19-year-old) as single dose for COVID-19 immunisation. Medical history included Polycystic Ovarian Syndrome, and eczema. Concomitant medications included ethinylestradiol, ferrous fumarate, norethisterone acetate (BLISOVI FE 1/20) and hydroxyzine, both taken for an unspecified indication, start and stop date were not reported. There was no other vaccine in four weeks. The patient previously took propylene glycol, scopolamine and experienced drug allergy. The patient previously took the first dose of BNT162B2, administered in Arm Left on 16Mar2021 12:00 PM (at age of 19-year-old) (Lot number: EN6207) for COVID-19 immunisation. It was reported on 09Apr2021 12:00, the patient experienced chills and flu-like symptoms that developed into difficulty breathing/chest pain. Nerve pain in neck, severe rib pain, and spitting up blood constantly. The patient started spitting up blood about two days after the vaccine. The patient experienced severe pain and difficulty breathing on12Apr2021. The patient received help from urgent care on 14Apr2021. On 14Apr2021, the patient was directed to receive a CT scan which revealed severe blood clotting in lungs. Rushed to ER where the patient was then admitted to the hospital overnight for observation and to receive blood thinners and pain medication. In the week since leaving the hospital the patient has experienced severe aches and pains all over her body and have continued to spit up blood. The events were reported 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).The patient was hospitalized for the events for 2 days. Events treatment included: O2, Blood Thinners, Oxycodone, and Morphine. No COVID prior vaccination. COVID tested post vaccination on 14Apr2021, Nasal Swab, COVID-19 RNA - SARS Cov-2 test result was Negative . The outcome of events were recovering.

Tonic Clonic seizure The patient (my daughter) does have epilepsy, but seizures are mostly well controlled with medication. She had not missed any medication doses. She had the first dose of the Pfizer Covid vaccine at 3:50 pm on 4/27/2021. She had a seizure later that night at around 10 pm.

She developed pain a week after date of injection, this seemed to get better but then returned again about 2 weeks later. Her L arm pain got progressively worse. She then received the 2nd dose of pfeizer vaccine on 4/19/2021 this time she got it in her R arm because of the pain in her L arm. Her L arm pain got worse to the point she was not able to feel her entire L arm. So she decided to go the ER

I started having vaginal bleeding on April 14th. The first day, it was the same amount as a regular period. In the days following, the bleeding became very heavy, having me go through a super-sized tampon with a pad every 1 and a half to two hours along with several large blood clots each time changing. On the 15th, I called the on-call nurse for my gynocologist and she said that it might have been from the vaccine and taking birth control, since many patients of hers had called with the same problem. The bleeding continued at this rate all the way until my second dose on April 29th. I saw my primary doctor that day and she tested my hemoglobin, which came up at 10.7, which was slightly anemic. She prescribed an Iron supplement and told me to skip my "period" days and go straight to my next pack of birth control when the one I was using was finished. The next day, I experienced severe nausea, diarrhea, chills, fever-like symptoms, difficulty breathing, and extreme fatigue. I went to the Emergency Room, and they gave me about an IV and a half. They said I had extreme dehydration, and was slightly more anemic than when tested the day before. Following that day, the bleeding was significantly lighter and then stopped for a few days on the following Thursday when I started my new pack of birth control. I had little to no blood for.a couple days, followed by bloody discharge up until Tuesday night, the 11th of May, when the bleeding started again, being about the same amount as a regular period. I am still currently bleeding at this rate.

Site: Pain at Injection Site-Mild, Systemic: Allergic: Anaphylaxis-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe

Pt brought to ED w/concerns for allergic rxn immediately following COVID-19 vaccine at PCP office (5/19) where w/in 15 mins, experienced significant lightheadedness, dizziness & throat swelling & itch w/wheezing. In ED, developed brief episodes of syncope and was administered EpiPen, IV fluids, solu-medrol and famotidine w/improvement. After multi doses of epi IM for recurrent symptoms throughout observation, was started on epi drip. Ultimately discharged, however, returned same night with recurrent anaphylactic rxn and was again started on an epinephrine drip and claritin. Of note, pt had previously had COVID on 1/22/2021. Pt discharged w/plans to f/u w/ allergy and immunology at Hospital.

1st day of pain: Extreme Pain in Lower Extremities (Right Leg, Right abdomen, right lower back) Swelling of Right Leg 3rd day: Admitted into the hospital after visiting the ER Acute DVT in R Leg, multiple Pulmonary Embolisms 3rd-5th day in hospital: 2 Surgical Procedures to remove blood clot, on Blood thinners for a year to life

2nd COVID19 Pfizer vaccine 5/1/21 lot # EW0167. both vaccines received at pharmacy. 5/24/21 awoke at 0400 with headache and nausea and vomiting. Headache worsened throughout the day and went to ED where she had syncopal episode and was treated for migraine headache with migraine cocktail and sent home. Symptoms continued and progressed the next day and she went to Hospital ED in where a CTH revealed SDH near her sinuses. She was transferred to Medical Center in for higher level of care. On arrival she had a CTH/CTA which revealed and extensive central venous sinus thrombosis.

blood clots; she did get really sick / she was displaying a lot of symptoms; fever; whole body was aching; fatigue; nauseated; bruises on the legs / now she's getting more / she would say they have worsened; This is a spontaneous report received from a contactable consumer (patient's mother). A 19-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0182), via an unspecified route of administration in arm left on 14May2021 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient previously received flu shot and experienced nausea. The patient experienced blood clots on an unspecified date, bruises on the legs, she was getting more, she would say they have worsened in May2021, fever on 15May2021, whole body was aching on 15May2021, fatigue on 15May2021, nauseated on 15May2021, and she did get really sick, she was displaying a lot of symptoms on an unspecified date. Patient started having bruises on the legs and thought that it might be related to blood clots. She mentioned that she also experienced the common side effects but she was not concerned of that as people she knew also had those symptoms but was more concerned about the bruising. On patient's legs, she had a bunch of bruises. Reporter was just really nervous about her daughter's bruises. When patient was working, she was not noticing, but today patient noticed her legs and said reporter it was a lot of them. Patient did get really sick with her first shot, she had a fever, she couldn't go to work the next day. Reporter was not sure if the patient should get the second dose on 04Jun2021. Patient's whole body was aching, she was nauseated, she was displaying a lot of symptoms. Reporter checked online and they said it was a normal thing. Patient came down and showed reporter the bruises. Patient wasn't really paying attention to them. Patient had one or two bruises when she noticed and at the time of the report she was getting more. They had worsened. Patient took ibuprofen (ADVIL) for fever and she felt better. Outcome of events blood clots and she did get really sick, she was displaying a lot of symptoms was unknown, of event bruises on the legs, she was getting more, she would say they have worsened was not resolved, and of other events was resolved.

One day after getting 1st covid vaccination vaginal bleeding for 21 days and joint pain. Joint pain has not subsided.

Patient reported anaphylactic type symptoms with swelling of her throat, shortness of breath, wheezing within 15-20 minutes after vaccination. Patient was taken to ER for further evaluation.

Patient reports that she started bleeding vaginally four days after receiving her first dose of the Pfizer COVID 19 vaccine. She already had a Nexplanon in place, had it removed on 03/18/2021 and a IUD placed the same day. She has been perscribed two different birth control pills (progesterone and estrogen) but is still bleeding "heavy".

Patient experienced shortness of breath and chest pain resulting in a visit to the ER (02/07/2021) where doctors found multiple blood clots in lungs as well as decreased heart function due to stress on cardiac system. Patient was hospitalized for 3 days and had to have an INR procedure to remove the blood clots (Patient is now on blood thinner and diagnosed with Antiphospholipid Syndrome after event.)

after receiving the shot, that night I started to have vaginal bleeding. My period ended well over a week ago and it?s strictly black blood. Also, The morning of Monday, June 28, 2021, one day after the vaccine from 6 AM until 10 AM I threw up 10 times. And today Tuesday, June 29 I am still bleeding black blood vaginally and now have cramps in my lower abdomen

Patient received her second COVID 19 shot on April 26, 2021. She began to feel general fatigue toward middle/end of May. Also at end of May she began to experience chest pain when working out. On June 14th she felt chest pain just walking and developed a cough. I took her to ER on June 15th around 1am. Her chest X-ray showed some abnormality. Around 3am she had significant difficulty breathing. She was admitted and a cardiologist and pulmonary physicians determined she was in heart failure with an ejection fraction of 10%. She was life flighted to another hospital where she spent 3 weeks on Echmo and Impella, received a heart transplant on week 4 and is still in ICU recovering. We are not sure if the vaccine is related to her illness. We just know that patient was a healthy 19 year old, former high school athlete, current straight A student having completed her freshman year of college, and no health issues prior to this event.

bleeding vaginally four days after receiving her first dose of the Pfizer COVID 19 vaccine; This is a spontaneous report from a contactable Nurse. This contactable Nurse reported for a 19-year-old female patient that: A 19-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for Injection), dose 1 intramuscular, administered in Arm Right on 22Jan2021 13:30 (Batch/Lot Number: EL9262) as dose 1, single for covid-19 immunization. Medical history included Drug hypersensitivity from an unknown date and unknown if ongoing penicillin allergy. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were no other medications the patient received within 2 weeks of vaccination. The patient experienced bleeding vaginally four days after receiving her first dose of the Pfizer Covid 19 vaccine on 26Jan2021. Nexplanon removal & IUD insertion treatment was received for event bleeding vaginally four days after receiving her first dose of the Pfizer COVID 19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and also since the vaccination, the patient has not been tested for COVID-19. The outcome of event was not recovered.; Sender's Comments: Based on plausible temporal relationship, a possible causal association between the event "Vaginal haemorrhage" and the 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.

I have a horrible sinus infection; Painful sore throat (puss in throat red it's gross); Painful sore throat (puss in throat red it's gross); This is a spontaneous report from a contactable consumer (patient) reported for herself. A 19-year-old female patient received bnt162b2 (PFIZER BIONTIC COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in left arm on 02Jul2021 at 10:30AM (at age of 19-year-old) (Batch/Lot number was not reported) as single dose for covid-19 immunisation. There was no medical history, no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included ethinylestradiol / norgestrel (ELINEST). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received the first dose of bnt162b2 on 02Jun2021 at 10:30AM (at age of 19-year-old) for covid-19 immunisation. The patient had been dealing with a painful sore throat (puss in throat red it's gross) and she had a horrible sinus infection on 05Jul2021 at 01:15 PM. No treatment was received for the event. The outcome of the events was not recovered. Since the vaccination, the patient had not been tested for COVID-19. No follow-up attempts are possible; information about lot/batch cannot be obtained.

anaphylaxis; high blood pressure; elevated heart rate; her throat felt funny, like it was getting tight; very nauseous/sick of her stomach; rash on her chest; She could not swallow; This is a spontaneous report from a contactable consumer (parent of the patient). Information were received also from a Pfizer-sponsored program COVAX US Support. A 20-years-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EL9261), via an unspecified route of administration in the left arm on 05Feb2021 09:30 at single dose for COVID-19 immunisation. Medical history included acne, allergy environmental cats dogs and latex. Adrenaline (EPIPEN) and Corticosteroid were used to treat these allergies. Due to these severe allergies, the patient had to take weekly allergy shots. Got allergy shot the day before the 2nd vaccine shot. Concomitant medication included isotretinoin (AMNESTEEM), buspirone (unknown manufacturer), calcium (unknown manufacturer), azelastine hydrochloride, fluticasone propionate (DYMISTA), gabapentin (unknown manufacturer), melatonin (unknown manufacturer), omeprazole (unknown manufacturer), estrogens conjugated, medroxyprogesterone acetate (PREMELLA), probiotics (PROBIOTICS), fluoxetine hydrochloride (PROZAC) , trazodone (unknown manufacturer), colecalciferol (VITAMIN D), cetirizine hydrochloride (ZYRTEC). The patient previously took clindamycin, bactrim and corticosteroids and experienced hypersensitivity. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EL3249) intramuscular in left arm on 15Jan2021 at 11:00AM. It was reported that 15 minutes after receiving her second COVID-19 vaccine dose the patient developed anaphylaxis, her throat started closing up, her throat felt funny, like it was getting tight. A nurse administered her anaphylactic shot (EPI-PEN shot) and was taken to the hospital by ambulance. The patient was monitored in the Emergency Room because her blood pressure and heart rate were up, but the Emergency Room didn't give her any further treatment. The patient was discharged home on 05Feb2021. On Saturday, 06Feb2021, at 4-5AM she developed anaphylaxis again, the patient had the same throat tightening happen again. The mother gave her an Epi-Pen shot (AUVI-Q) and brought her back to the Emergency Room. While in the Emergency Room, the patient was given steroids and Pepcid, and then sent back home. On Sunday, 07Feb2021, at approximately 1:00AM she had the same throat tightening so the mother gave her an Epi-Pen shot (AUVI-Q) again, and brought her back to the Emergency Room. The patient was admitted to hospital and discharged on 09Feb2021 evening (at 16:00). At hospital the patient received some steroid shots in the hospital. The patient was given 3-125mg steroid shots, and 3-40mg steroid shots, every night she spent in the hospital, she woke up with her throat closing and she was administered 125 steroids 50 mg Diphenhydramine (BENADRYL) and 4-5 hours later 40 mg of steroids 20 mg Famotidine (PEPCID) IV. They kept IV fluids. On 10Feb2021 at 7:50AM the patient experienced throat tightness again. The mother gave her some Diphenhydramine (BENADRYL) and steroids which were prescribed at hospital. The patient started a taper dose of Prednisone 10mg tablets. She was to take 2 Prednisone 10mg tablets twice a day for 3 days, then to take 2 Prednisone 10mg tablets in the morning and 1 Prednisone 10mg tablet in the evening for 3 days; then to take 1 Prednisone 10mg tablet twice a day for 2 days, and then 1 Prednisone 10mg tablet daily for 2 days. The patient was prescribed generic Famotidine (PEPCID), 40mg, one tablet, twice a day, and generic Diphenhydramine (BENADRYL) 25mg capsules. On unknown date in feb2021 the patient gets very nauseous when her throat starts to close. She could not swallow and was sick of her stomach. She experienced a rash on her chest. The outcome of the event heart rate increased and blood pressure high was recovered, for anaphylactic reaction and throat tightness was not recovered. For the other events was unknown. The events anaphylaxis, throat tightness, heart rate increased and blood pressure were serious due to hospitalization.

20 y/o female, s/p 1st vaccine. C/o blurred vision, pale, diaphoretic. Code green called by clinic staff, med consult, and medic with patient, laid down onto cot. Cold water bottle applied to neck, ice to head by staff. Speech clear, he of allergies to MMR per mother. Symptoms resolving, pt signed out AMA with medic. Cleared by med consult Dr to go home. Requested pt to remain on site for additional 15 minutes. Head of cot raised, eating Cliff Bar and drinking Gatorade. C/o feeling tired. Escorted to car via wheelchair with mother. Denies any symptoms.

experiencing passing a ton of clots; I washed my face, it got extremely red; This is a spontaneous report from a contactable consumer (patient). A 20-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported) at the age of 20-year-old, via an unspecified route of administration, administered in the left arm on 19Jan2021 13:00 as single dose for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. Medical history included lupus and idiopathic thrombocytopenic purpura (ITP). Concomitant medications included mycophenolate mofetil (CELLCEPT), esomeprazole magnesium (NEXIUM), medroxyprogesterone acetate (DEPOPROVERA), and propranolol; all taken for an unspecified indication, start and stop date were not reported. The patient has known allergies to rituximab and amoxicillin. As a woman, the patient was having a lot of blood clots being passed. The patient doesn't get a period because of depo, but for some reason, she was experiencing passing a ton of clots on an unspecified date. Also, after the first dose, when she washed her face, it got extremely red on an unspecified date in 2021 (She did the same in the days before and that didn't happen). The patient underwent lab tests and procedures which included Covid test: negative on an unspecified date. The outcome of the events was unknown. No treatment was received for the events. The patient received the second dose of BNT162B2 on 11Feb2021 for COVID-19 immunisation administered at the left arm. Information on the lot/batch number has been requested.

This patient was admitted to the Hospital ICU on 4/8/2021 after developing rigors, chills, hypotension and a fever to 105 F after getting her second dose of Pfizer vaccine on 4/7/2021. She also was noted to have a platelet count of 12 that responded to IVIG and she was diagnosed with Immmune Thrombocytopenia.

I took the vaccine on 14th April, at 1:30pm, on that night I started having vaginal spotting as well as cramping which felt like period cramps, on 15th night I started having my periods. My periods were supposed to be on 28th April, also it?s my third day of period and my period hasn?t been this heavy in a long time.

small clot behind my left knee; left foot had swollen; This is a spontaneous report from a contactable consumer (patient). A 20-year-old female patient received BNT162B2 (lot number: ER2613) first dose on 20Mar2021 10:15 on left arm at single dose for COVID-19 immunisation. Medical history and concomitant medications were none. Patient is not pregnant. No other vaccine in four weeks. No Covid prior vaccination, No known allergies. She took the vaccine around 10:00am and around 6:00pm (also reported as 06:30 PM) she noticed that her left foot had swollen. She consulted with her general physician and he requested that patient did an Ultra Sound exam of her left leg. The result of the exam reported a small clot behind her left knee. Therefore, doctor suggested that she reported these events to Pfizer so an evaluation is made to identify if similar events have occurred with other patients. She was concerned if she should take the second shot on 17Apr2021. AE resulted in Doctor or other healthcare professional office/clinic visit. Patient received Eliquis 5mg (two times daily) as treatment. Patient had Nasal Swab on 01Apr2021 and tested negative. The outcome of the events was not recovered.

Patient with PMH significant for asthma, allergies to shellfish and peanuts, presents to ED for evaluation of difficulty breathing. Mother reports the patient had been wheezing for the past week, and gradually worsened. Per mother, prior to arrival patient could not breath and having increased respiratory distress. Just prior to arrival the patient became unresponsive. The patient was tachycardic, tachypneic, hypertensive and hypoxic. The patient was emergently intubated and placed on mechanical ventilation. Per the patient's mother. The patient received her first dose of COVID vaccine the day before arrival to the ED. Diagnosis: Acute Respiratory Failure; Acute Asthma Exacerbation verses Allergic Reaction.

had two blood clots on her lungs; This is a spontaneous report from a contactable consumer. A 20-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose at the age of 20-years-old via an unspecified route of administration, administered in arm left on 28Mar2021 12:30 (Batch/Lot Number: ER8730) as single dose for covid-19 immunisation. Medical history included birth control from an unknown date and unknown if ongoing. Concomitant medication included ethinylestradiol, norgestimate (SPRINTEC) taken for birth control from Dec2020 to 12Apr2021. The patient experienced had two blood clots on her lungs on 12Apr2021 18:00. The patient was hospitalized due to the event from 12Apr2021 to 14Apr2021. The patient was recovering from the event.

after 3 years of not having her period, she suddenly started bleeding heavily and having menstrual cramps. The bleeding was very clotted and seemed somewhat abnormal; after 3 years of not having her period, she suddenly started bleeding heavily and having menstrual cramps. The bleeding was very clotted and seemed somewhat abnormal; after 3 years of not having her period, she suddenly started bleeding heavily and having menstrual cramps. The bleeding was very clotted and seemed somewhat abnormal; This is a spontaneous report from a non-contactable consumer. A 20-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation (Age at vaccination: 20 years). The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient stated that after 3 years of not having her period, she suddenly started bleeding heavily and having menstrual cramps. The bleeding was very clotted and seemed somewhat abnormal. The patient underwent lab tests and procedures which included nasal swab: negative on an unspecified date. The patient did not have COVID prior vaccination. The patient was not pregnant. Outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Initially presented with a headache 3 days past vaccine, presented to hospital now found to have dural venous sinus thrombosis. Currently stable on anticoagulation drip.

The patient was presented to ER 4/27 with progressive swelling of R arm associated with shoulder pain. Admitted to ER 4/27-4/29 admitted by the doctor for right subclavian vein thrombus, right axillary and right brachial vein thrombus and bilateral pleural blebs largest measuring 2.1cm with small pulmonary emboli within segmental artery to the right lung base posteriorly and within the segmental artery to the left lower lobe, right sided thoracic outlet syndrome She was on Heparin drip and started on Eliquis Discharged on Eliquis She was on Xulane patches for birth control and was taken off Xulane after finding the clots Also of note she received Pfizer vaccine 1 week prior to presenting to ER

Patient received Pfizer vaccine at 1054am Reaction started at 1105am. Patient stated blurred vision, diaphoretic, salty mouth, and nauseous. RN requested help and patient was laid back down on the ground. Cold washclothe applied to neck and forehead. 12.5/5ml Diphenhydramine given oral solution After about 20 minutes, patient verbalized she felt better - she was brought inand iupright postion and seated in an chair w/o issue. Blood pressures taken at time of incident and through out monitoring - Vital unremarkable. Rn called patient mother , who was able to come to the clinic to pick up patient. At time of pick up patient started to feel additional reaction, CF team at medical facility called for additional intervention. FNP from CF team advised to get orthostatic BP and record. Ortho Static taken with a drop in BP from laying to standing. BP was as low as 50/30 P:66 O2: 98 on RA 911 activated as patient conitnued to have sudden decrease in BP. Patient went to the hospital via EMS. Patient parents and twin sister with patient. Admin notified - chart documented.

Vaginal bleeding 6 hours after vaccination. The last menstruation period ended on 5/22/21. Taking birth control which makes period very regular. Was not projected to get my next period until 6/15/21.

Extreme sharp pain on right side of back when breathing - on 4/14/21 Went to primary care physician on 4/15/21 He had blood work and x-rays done - d-dimer came back 4 Admitted to ER In ER CT done - found pulmonary emboli (severe on the side where the pain was) Admitted to ICU that night (4/15/21) Stayed in ICU for 3 days Moved to floor Discharged from hospital on 4/19/21 Still dealing with extreme fatigue (unknown cause) still on blood thinners - 5/25/21

Had some crazy nosebleeds beginning 4 days after my first dose. I ended up pulling a gigantic blood clot out of my nose during the first one. It was terrifying. I?ve had 6 nosebleeds since my first dose and I?ve never had issues with nosebleeds before. They last a long time too and each one comes with a clot. I also have bruises all over my legs and that have appeared randomly and if I get cut I take forever to stop bleeding.

Symptoms started with tightness of muscles and body aches, tightness of chest, increased blood pressure, herpes simplex A mouth sores - saw PMD received muscle relaxer, and antibiotic cream... in the 30 days prior to last event she had been having dizzy spells, chills, hot flashes, shortness of breqth, tightness of chest, darkened urine, muscle cramping and knotting, pitting edema, halo discoloration lower right extremity (she wasnt one to complain and thought her symptoms were from use of muscle relaxer) - woke AM 6/11/2021 with severe shortness of breath and was taken to ER - diagnosed with obesity, cardiomegaly, renal failure, severe anemia, hypoxia, and hypokalemia, she went into respiratory distress AM 6/12/2021 and then went into cardiac arrest. She died as a result.

After about a week or less following each shot of the COVID-19 vaccine, my menstrual cycle began to experience SEVERE irregularities. As someone who has been on the same birth control for many many years (brand/type is NORG-EE oral contraceptives), with no previous issues and an extremely regulated cycle, the effects I experienced were far from normal. My periods came a week early, and lasted for the entirety of the rest of the cycle (totaling 2 weeks of bleeding). The bleeding was extremely heavy containing intense and large clotting for the entirety of the period. Aside from losing a tremendous amount of blood, I have experienced heavy cramping in the lower abdomen and lower/mid back regions both during these periods and even sometimes when I am not bleeding at all. These side effects coupled have caused me to feel fatigued to the point of feeling like I needed to pass out, and due to this I adopted to taking iron supplements daily during the irregular bleeding (chelated iron, 18 mg capsules as recommended). As a result of this concerning symptom, I scheduled a visit to see my primary OBGYN, and was told that this is a common issue that they have been seeing following patient vaccinations. It is my hope that my periods will be regular this month, but for now I am unsure that this issue has resolved.

Anaphylaxis (raised heart rate, rash, nausea and vomiting, swollen lips and throat) difficulty breathing - anaphylaxis under control Cause may be a salad Breathing still doesn?t feel normal

Woke up with a loud heartbeat and severe chest pain, especially when breathing in - shortness of breath, dizzy/confused, anxious. Went to the emergency room and was given an ECG which was abnormal, tested positive in blood test for blood clot but was negative on a CAT scan. Doctor stated it was minor myocarditis, was perscribed ibuprofen and percocet and sent home

Anaphylactic reaction- started shortly after. Rapid response called about 7:45. Blood pressure elevated, heart rate elevated, oxygen 90, itching face/chest with a rash.

Rash on lower legs similar to that seen with Thrombocytopenia.; Rash on lower legs similar to that seen with Thrombocytopenia.; This is a spontaneous report from a contactable Other HCP (patient). A 21-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number= EJ1686), via an unspecified route of administration at Left arm on 05Jan2021 10:00 AM at single dose for covid-19 immunization. The COVID-19 vaccine was administered at Hospital. The patient's medical history and concomitant medications were unknown. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced rash on lower legs similar to that seen with thrombocytopenia on 09Jan2021 at time of 12:00 PM. No treatment received for the events. 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 the events was not recovered.; Sender's Comments: A possible contributory effect of suspect drug on reported thrombocytopenia 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.

Progress Notes (Nurse Practitioner) ? ? Family Medicine Cosign Needed Expand AllCollapse All COVID VACCINE CLINIC 2/24/2021 Date: 02/24/2021 Subjective Patient is a 21 y.o. adult who was seen at COVID Vaccine Clinic today for patients first dose of the COVID 19 vaccination. Patient was given the Pfizer vaccination in the left deltoid muscle. During patient's 30 minute waiting period after the injection, the patient began to experience throat tightness and itching. Patient denied rash, difficulty breathing, difficulty swallowing, wheezing, hoarseness, stridor, itching, lightheadedness, dizziness, facial swelling, lip swelling and tongue swelling. This provider was notified of patient reaction and patient was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to blood pressure abnormality , drooling, increased swelling, rapid progression of symptoms, respiratory distress, skin changes and tongue swelling. PMH: includes peanut allergy, carries epi-pen. She takes 75 mg of benadryl nightly to help with insomnia and seasonal allergies. ALLERGY REVIEW OF SYSTEMS: Patient complains of itching of skin Patient denies chills, malaise/fatigue, facial swelling, itching in ears, sore throat, frequent throat clearing, eyes itching, cough, chest tightness, shortness of breath, wheezing, rash, abdominal pain, muscle aches, dizziness and headaches Previous Reactions: she was brought back to bay intially for observation as she reported to pass out when she gets shots. Shortly after injection, she developed symptoms above. No vagal issues arose. Objective Vitals Vitals: 02/24/21 1048 02/24/21 1100 02/24/21 1136 BP: (!) 153/85 106/76 124/72 Pulse: (!) 101 86 81 Resp: (!) 22 16 SpO2: 99% 100% 100% Physical Exam Vitals and nursing note reviewed. Constitutional: General: Patient is not in acute distress. Appearance: Normal appearance. Patient is well-developed. Patient is obese. Patient is not diaphoretic. HENT: Mouth/Throat: Mouth: Mucous membranes are moist. Pharynx: Oropharynx is clear. Comments: Clear oral airway Eyes: General: Right eye: No discharge. Left eye: No discharge. Conjunctiva/sclera: Conjunctivae normal. Neck: Thyroid: No thyromegaly. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. 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. Capillary Refill: Capillary refill takes less than 2 seconds. Comments: Injection site without rash, erythema or swelling Neurological: General: No focal deficit present. Mental Status: Patient is alert and oriented to person, place, and time. Psychiatric: Mood and Affect: Mood normal. Behavior: Behavior normal. Thought Content: Thought content normal. Judgment: Judgment normal. Assessment/Plan Treatment included: antihistamines Follow up response to treatment: excellent. Patient discharge: Stable to go home and follow up with PCP. Differential Diagnosis: Vaccine-Related Anxiety (include misc mental health) and Anaphylaxis (dyspnea, stridor, drooling, tongue swelling) Close monitoring. Pt improving. Doing well with medication intervention. Pt has ride. Pt wheeled out to the front. Pt ambulates without difficulty. No dizziness. Instructions given on when she can take her next benadryl dose. APRN Electronically Signed 2/24/2021 11:25 AM

Patient had critically low thrombocytopenia (low platelets) discovered via lab. Platelets had previously been normal.

Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium

Patient contacted 911 complaining of not feeling well and difficulty breathing. Upon arrival patient was found by EMS in cardiac arrest. EMS was unable to get return of spontaneous circulation.

Our daughter began having bone pain around 9 p.m. She threw up approx 11 p.m. Through the night, she began to develop a fever 101.9. Around 5 p.m she said something was wrong over and over. We got ready to go to ER. She wanted to go to bathroom and throw up. When she did, she had a grand mal seizure. My husband had to begin CPR. Fire Rescue team arrived and transported to ER. She was treated and released. Follow up with cardiologist, primary care, and neurologist.

My throat / tongue swelled, difficultly breathing and swallowing (anaphylaxis). Urgent care rushed me in and gave me dexamethasone in my right arm to stop the swelling as well as Tylenol. It took about a full week to completely feel normal, mild anxiety attacks happened. But after one week felt good again.

Hospitalization with pneumonia and E coli sepsis on 4/2/2021 Symptoms started with sore arm on 3/30/2021. Patient called healthcare provider on 3/31/2021 because patient developed headache, myalgias, fatigue, fever to 100. On 4/2/2021, patient presented to ER and admitted to hospital with fever, chills, shortness of breath, productive cough, labored breathing. CXR showed left upper lobe pneumonia and small pleural effusion. Blood culture subsequently grew E. coli. Work up for source of E. coli is ongoing including CT scan due to patient's history of rectal inflammation and presacral abscess several months back.

Had grand mal seizure; This is a spontaneous report from a contactable consumer (patient). A 21-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 12Mar2021 08:00 (Lot Number: EN6205) as SINGLE DOSE for COVID-19 immunisation; and pefloxacin mesilate (PEFCID), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication. Medical history included, iodine allergy, yellow dye allergy and dysautonomia; all from an unknown date and unknown if ongoing. Concomitant medications included fexofenadine hydrochloride (ALLEGRA) taken for an unspecified indication, start and stop date were not reported. The patient was not pregnant at time of vaccination. The patient previously had first dose of BNT162B2 (lot number: EN6200,) on 19Feb2021 13:15 in left arm for COVID-19 immunization. On 13Mar2021 05:30, the patient had grand mal seizure reported as serious and life threatening since in an immediate risk of death. The event resulted in visit to emergency room/department or urgent care. The facility where the most recent COVID-19 vaccine was administered was in the Vaccine Clinic. 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 outcome of the event was recovering. The patient underwent lab tests and procedures which included COVID-19: negative on 13Mar2021. The patient received treatment for the event. The action taken in response to pefloxacin mesylate for the event was unknown.

Patient loss consciousness. Vaccine administered around 1240, approximately at 1250 patient pass out. Observer called for help and EMS was activated at 1250. Patient was flushed and not breathing, observer pushed EpiPen 0.3mL (Lot #0FM200 Exp: OCT2021)for 10 seconds at 1252. Patient woke up, helped arrived and was moved into private patient room. Fire was called at 1254 arrived at 1303. Vital signs taken at 1258 BP: 71/39 HR:73 O2: 100% Temp:98.7 degrees Celsius. Second Vital signs taken at 1300 BP: 86/49 HR:97 O2: 99% Temp:98.7 degrees Celsius. Patient stated before passing out symptoms of light headedness and heart racing and flushed. Patient improving symptoms, transported to the Hospital at 1307.

The day following the injection, I had vaginal spotting that was bright red, not clots, and severe cramping. Note that this was not during the menstruation portion of my cycle. It lasted for about 2 hours.

started bleeding, period symptoms, and it has progressed much worse; This is a spontaneous report from a contactable consumer (patient). A 21-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in Arm Left on 29Mar2021 15:00 as single dose for covid-19 immunisation. Medical history included birth control. Patient is not pregnant. Concomitant medication included medroxyprogesterone acetate (DEPO-PROVERA shot) taken for birth control. Within an hour of receiving, patient started bleeding, period symptoms at 04:00 PM on 29Mar2021, and it has progressed much worse. This makes patient question the integrity of her birth control, a depo shot once every 3 months. Patient visited doctor or other healthcare professional office for the event. No treatment received. It was unknown if patient had covid prior vaccination. No other vaccine in four weeks. Patient did not test covid post vaccination. Outcome of the event was recovering. Information on the Lot/batch number has been requested.

She developed red dots (petechiae) and bruising on Saturday. She also developed vaginal bleeding on Saturday that was heavy and had clots. Her period was ending on Saturday and had been normal up to that point. She continues to have heavy vaginal bleeding. Went to PCP and routine labs revealed thrombocytopenia. She has never had thrombocytopenia before. Was sent to ED for blood transfusion and was admitted to hospital. Dishcarged home 4/27 after platelet infusion.

Menstrual period that was 9 days late with extremely heavy bleeding and abnormally large clots (larger than a quarter), PMS symptoms that lasted for 2+ weeks before my period started (cramps, sore breasts, tender/tingling nipples, dizziness, acne)

Patient presented to the ER one day post second dose of vaccine with chest pain and was diagnosed with pulmonary embolism.

Allergic reaction/Anaphylactic shock; Hives; This is a spontaneous report from a contactable consumer. This consumer reported different events for two patients. This is 1 of 2 reports. A 21-year-old female patient (reporter's ((Name)colleague's daughter) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration on 04May2021 (Batch/Lot Number: EW0171) (at the age of 21-year-old) as 2nd dose, single dose for covid-19 immunization. Medical history included allergy with garlic. The patient's concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 on an unspecified date for covid-19 immunization. The reporter stated that on 04May2021 the patient got vaccinated with the second dose of vaccine and two days later i.e., on 06May2021 she had some hives, but she never had it before, and she developed an allergic reaction and was in an emergency room having anaphylactic shock and was hospitalized for 3 time and treated with Epinephrine (treatment). She went to an allergist and they checked, they said she did not have any allergy. The outcome of the events was unknown. Information on Lot/Batch number was available. Additional information has been requested.

The first day after I received my shot I was running a fever of 102. My side effects passed by May 29th, 2021. On May 21st I went to the hospital due to vaginal bleeding. While at medical center I was told I had a miscarriage. I was showing at 4 weeks when I was supposed to be 7 weeks. I found out I was pregnant on April 30th. I got my first dose on May 5th. My first shot I just had soreness, but I?ve had a previous successful pregnancy but lost this one between my first and second dose.

Extreme vaginal bleeding; Some difficulty in breathing; Prolonged period; Migraines; Dizziness; Nausea; Lower back pain; Abdominal pain; Weakness; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 21-years-old female patient (patient was not pregnant at the time of vaccination) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: ER8735, Expiration date: unknown) via an unspecified route of administration, administered in left arm on 10May2021 (age at vaccination was 21 years) as 2nd dose, single for COVID-19 immunization. Medical history included known allergies to Sulfas. The patient's concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: ER8735, Expiration date: unknown) via an unspecified route of administration, administered in left arm on 19Apr2021 (age at vaccination was 21 years) as 1st dose, single for COVID-19 immunization. The patient previously took amoxicillin and experienced known allergies. The facility where the most recent COVID-19 vaccine was administered was Other. 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 has been tested for COVID-19. The patient underwent lab tests which included Nasal Swab: negative on 21May2021. On 28May2021, patient experienced extreme vaginal bleeding/ prolonged period/ migraines, dizziness, nausea, lower back pain, abdominal pain, some difficulty in breathing and weakness. The adverse events resulted in Doctor or other healthcare professional office/clinic visit. No treatment was received for the adverse events. The device date was reported as 23Jun2021. The case was reported as non-serious. The outcome of events was not resolved. Information on lot/batch number was available.

vaginal bleeding; abdominal pain; This is a spontaneous report from a contactable consumer. A 21-years-old non-pregnant female patient received second dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, lot number: 8733) via an unspecified route of administration in the left arm on 25Mar2021 at 09:00 (at an age of 21 years) as a single dose for COVID-19 immunisation. The patient did not have any medical history. The patient had seasonal allergies. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: 6205) via unspecified route of administration in the left arm on 04Mar2021 at 09:00 (at the age of 21-years-old) as a single dose for COVID-19 immunisation. Medications within two weeks of vaccination include medication for birth control. Prior to vaccination, the patient was not diagnosed for COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 27Mar2021 at 09:00, after two days of the second dose of vaccine, the patient experienced spotting with light vaginal bleeding. The patient reported that she had been on birth control for almost three years and had never spotted, and the patient always had period on the same exact day (which was not supposed to happen for another 10 days). The patient also experienced abdominal pain while it was happening. The patient did not receive any treatment for adverse 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 the events light vaginal bleeding and abdominal pain were unknown. No follow-up attempts possible. No further information expected.

Menstrual cycle irregularities; Mild spotting after first dose; This is a spontaneous report from a contactable consumer (patient). A 21-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EP6955), via an unspecified route of administration on 23Mar2021 (at the age of 21-year-old), as dose 1, single in left arm for COVID-19 immunisation at hospital. The patient's medical history was reported as none. Patient had no known allergies. Concomitant medication received within 2 weeks of vaccination included Aurovela Fe for duration of 6 months, taken as birth control pills, start and stop dates were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unspecified date in 2021, the patient experienced menstrual cycle irregularities and mild spotting after first dose. This was abnormal as she had been perfect on birth control pills for 6 months. The patient did not receive any treatment for the events. The patient had no COVID prior vaccination and was not tested COVID post vaccination. The clinical outcome of the events was resolved in 2021. Information on Lot/Batch number was available. Additional information has been requested.

She stopped breathing; She like passed out but her eyes were still open; her vision started to go; Her vision start to get blurry; She started getting very hot; her vision started to go; Her vision start to get blurry; This is a spontaneous report from a contactable consumer. This consumer reported for a 21-years-old female patient. A 21-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: EY0196 and Expiry date was not reported) dose 1 via an unspecified route of administration in Left arm on an unspecified date (21-year-old at the time of vaccination) as dose 1, single for covid-19 immunisation. Medical history was none. The patient was healthy. Concomitant Medication used for Just birth control (drug name not clarified). On unspecified, same day of vaccination the patient started getting very hot, has stopped breathing, like passed out but her eyes were still open, her vision started to go, her vision start to get blurry. The reporter stated that On unspecified date after 10, 5 minutes when it happened a pharmacy tech did gave her the EpiPen (treatment) because that's how we found out of it she was not with it, she was passed out, she stopped completely. she took the vaccine and they were sitting there you know to wait to make sure she didn't have reactions she started getting very hot. She poured water on herself because she was so hot then her vision started to go and her vision start to get blurry and the patient called the reporter to come stand by her when reporter walked over there she like passed out but her eyes were still open and she was calling my name looking at me but she was looking at me but she wasn't there, she was like looking straight through me. She stopped breathing, it was a horrible experience." The reporter stated that the patient had had a severe reaction after first dose. The reporter stated that She supposed to receive 2nd dose, its the 23rd but she is not getting it. The Reporter stated, "Yes, I would like to speak with somebody in regards to what she went through and what might affect if anything else is going to happened to her." Reporter stated, "So, when I call, I will speak to a medical professional and they'll have this information to discuss it with me and help me you know, because I mean, I wanna know, what I need to pay attention to if she is gonna have more other side effects from this or what." No laboratory tests. The outcome of the events was unknown. Follow-Up: Follow-up attempts are completed. No further information is expected.

4/14/21 became confused and had cardiac arrest with seizure EMS called 1757 was taken to 2 hospitals with multiple resuscitation efforts and defibrillations declared deceased 0042 4/15/2021

Patient's arm was sore after receiving the vaccine, 3 days later she woke up with numbness. She went to the hospital and was diagnosed with a blood clot in her arm. She was placed on warfarin and the clot dissolved. Her OBGYN lowered her dose of birth control. Her PCP advised her to still get her second dose.

Chills; Fever; The next day after vaccine, I started abnormal vaginal bleeding 10 days before my period; My breasts are swollen and hurt; My breasts are swollen and hurt; Cramping all over my body and in my uterus; Cramping all over my body and in my uterus; This is a spontaneous report from a contactable consumer (patient). A 21-years-old female patient received second dose of bnt162b2 (PFIZER-BIOTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown), via an unspecified route of administration, administered in arm right on 09May2021 at 11:30 (at the age of 21-years-old) as single for COVID-19 immunization. The patient did not had medical history and did not receive any concomitant medications. The patient previously received the first dose of BNT162B2, administered in arm right on 24Apr2021 at 11:30 for COVID-19 immunization. It was unknown whether the patient was pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 10May2021 at 09:00, the patient experienced abnormal vaginal bleeding 10 days before her period, her breasts was swollen and hurt, she had terrible cramping all over her body and in her uterus, she had an ongoing fever and chills. She was still bleeding it was day 11. No one was helping her and she was in so much pain. The events did not led to prolongation of hospitalization. The patient did not receive any treatment for the events. The outcome of all the events was not resolved. Information on the lot/batch number has been requested.

Systemic: Anaphylaxis-Severe, Systemic: Rash (other than injection site)-Medium, Systemic: chest/throat tightness-Medium

she was diagnosed with bilateral deep vein thrombosis (DVT) and pulmonary embolism (PE); she was diagnosed with bilateral deep vein thrombosis (DVT) and pulmonary embolism (PE); This is a spontaneous report from a contactable nurse (patient). A 22-year-old female patient received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EK9231), via an unspecified route of administration in left arm on 06Jan2021 13:45 at single dose for COVID-19 immunisation. Medical history included allergy to all fish, and clots. The patient was not pregnant. There were no concomitant medications. The patient previously received 1st dose of BNT162B2 (lot numer: EH9899) in left arm on 16Dec2020 13:45 for COVID-19 immunisation and experienced left sided lower back pain on 20Dec2020. No other vaccine received in four weeks. It was reported that the patient had the first covid vaccine on 16Dec2020 and on 20Dec2020 started with left sided lower back pain and then received the second on 06Jan2021 and then on 09Jan2021 11:00 her legs became blue and swollen and she was diagnosed with bilateral deep vein thrombosis (DVT) and pulmonary embolism (PE). The patient otherwise healthy and had never had covid. Other than the clots, she had no other health issues. The patient underwent lab tests and procedures which included nasal swab: negative on 09Jan2021. Events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization, and life threatening illness (immediate risk of death from the event), hospitalized for 2 days (in Jan2021). Adverse event treatment: heparin drip and xarelto at home. Recovered with lasting effects on an unspecified date of Jan2020. This case was reported as serious, serious criteria was life threatening, caused/prolonged hospitalization.; Sender's Comments: The underlying risk factors/predisposing condition of thrombotic diathesis have been assessed to have played a contributory role toward the events.

Patient admitted on 2/21/21 and died in hospital on 2/22/2021. Patient had a significant, lifelong underlying medical condition.

Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Allergic: Itch Generalized-Severe, Systemic: Allergic: Rash Generalized-Severe, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Shakiness-Severe, Additional Details: Patient had her own Epipen with her since she has many allergies and just had anaphylactic reaction as recently as Monday. She began to feel itchy and had redness, rash after shot during the 30 minute observation period. Epipen was self-administered and emergency services called.

Patient had a generalized tonic-clonic seizure while at work, three days after receiving the COVID vaccine. The seizure self-resolved after about 4 minutes and patient returned to baseline soon after. She was taken to the emergency department for further evaluation. Patient had been feeling well after the vaccine. Patient was seen by neurology and started on keppra.

Patient stated she felt sudden onset shortness of breath and substernal chest discomfort starting 4/19/2021 just after the noon hour. She presented to the ER at 1:40pm on 4/19/2021. Patient was treated immediatly, including placing patient on 2L O2, EKG performed, labwork drawn, and 1mg/kg lovenox given SQ. Patient taken for CTA of chest, which showed saddle pulmonary embolism. Patient sent for mechanical thrombectomy, which was performed in the evening of 4/19/2021, and patient admitted to Medical Center for follow up care after procedure.

Patient had large amount of bleeding (soaking clothing) immediately following vaccine. Bleeding has now stopped.

On April 5th, 2021 I went to the E.D. , for shortness of breath and severe right shoulder pain. While there they got a chest x-ray, ran labs, and did a chest CT. The CT revealed that I had one blood clot in my left lung and two blood clots in my right lung, as well as slight pleural effusion in the right lower lobe. They put me on Xarelto for the next 3-6 months and monthly follow up visits with my primary care provider. I was also given Hydrocodone as need. I experienced extreme pain with breathing and sort of movement for a week and half but currently only have occasional shoulder and back pain usually at the end of the day.

Anaphylactic reaction immediately after vaccination; This is a spontaneous report from a contactable consumer (patient). A 22-year-old non-pregnant female patient received the first dose of BNT162B2 (BNT162B2; Batch/Lot number was not reported), via an unspecified route of administration, administered in right arm on 18Mar2021 16:00 at single dose for COVID-19 immunization. The patient's medical history included asthma, known allergies to legumes, soy, egg, and tree nuts. The patient's concomitant medications were not reported. The facility type vaccine was hospital. The patient had no other vaccine in four weeks. The patient experienced anaphylactic reaction immediately after vaccination on 18Mar2021 16:00. The event resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care visit. Therapeutic measures were taken as a result of the event and included treatment with Epi pen injection. The patient had no COVID prior vaccination and has not been tested for COVID post vaccination. The outcome of the event was recovered on an unspecified date. Information about lot/batch number has been requested.

1 pulmonary embolism in the left lung, 2 pulmonary embolisms in my right lung; a slight pleural effusion in the right lower lung; This is a spontaneous report from a contactable consumer (patient). A 22-year-old female patient received second dose of BNT162B2 (Lot Number: EM9809), via an unspecified route of administration, administered in the left arm on 13Mar2021 14:00 at 22 years-old, as a single dose for COVID-19 immunisation. Medical history included Known Allergies: Penicillin and COVID-19, both on an unknown date. Concomitant medications included ethinylestradiol, levonorgestrel (CAMRESE LO) taken for an unspecified indication, start and stop date were not reported; ergocalciferol (VIT D) 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 previously took amoxicillin, diphenhydramine (BENADRYL), xylometazoline hydrochloride (SUDAFED), guaifenesin and all experienced allergies. The patient previously received first dose of BNT162B2 (Lot Number: EM9809), via an unspecified route of administration, administered in the left arm on 20Feb2021 14:00 at 22 years old as single dose for COVID-19 immunisation. On 05Apr2021 18:00, the patient experienced 1 pulmonary embolism in the left lung, 2 pulmonary embolisms in the right lung and a slight pleural effusion in the right lower lung. The events resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care and considered as a Life threatening illness. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of all the events which included Xarelto and Hydrocodone. The outcome of the events was recovering.

Vfib cardiac arrest admitted to the ICU one week after receiving second dose of Pfizer vaccine. Unclear if related to vaccine administration but pt is 22 years old with no prior cardiac history. Pt still currently admitted but recovering.

Anaphylaxis; This is a spontaneous report from a contactable consumer (patient). A 22-years-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration, administered in arm left on 14May2021 11:00 (Batch/Lot number was not reported) as 2nd dose, single for covid-19 immunisation. Medical history included asthma, rocky mt spotted fever, MRSA, sepsis x2, mono (monocytes) from an unknown date. The patient's concomitant medications were none. No other vaccines within 4 weeks prior to the COVID vaccine. No any other medications the patient received within 2 weeks of vaccination. The patient received first dose of bnt162b2 on 23Apr2021 for covid-19 immunization at 22-year-old. Prior to vaccination, the patient was not diagnosed with COVID 19. Since the vaccination, the patient has been tested for COVID 19. The patient experienced Anaphylaxis, swollen closing throat,sob, wheezing, itching, dizziness on 14May2021 11:45. The adverse event result in Emergency room/department or urgent care. Therapeutic measures were taken as a result of all the events, treatment included Epi,Prednisone,Benedryl, IV. The outcome of the events was recovering. Information about lot/batch number cannot be obtained. Additional information has been requested.; Sender's Comments: Based on the known safety profile of the drug and plausible temporal relationship, a causal association between the event of Anaphylactic reaction and suspect drug BNT162B2 cannot be excluded

Fatigue, increasing shortness of breath for 1-2 weeks, diagnosed with pulmonary embolus on 6/2/21 in emergency department

5/20/21: - I received my 2nd dose of Pfizer vaccine - I had severe chills and fever for two days 5/23/21: - Chills & fever subsided, but I woke up with a severe headache that lasted all day long despite taking ibuprofen 5/24/21: - Headache continues so I called the Doctor, am told it?s a vaccine symptom that should subside in a couple days & get prescribed Naproxen for the pain 5/28/21: - I try to ween off the medication, but the migraine is still there and now throbbing worse than ever - I call the Doctor again, this time I?m advised to get my eyes checked out and make an appt. with my primary physician 5/29/21: - Eye exam came back healthy and normal 6/1/21: - Went to appt. with PCP and she sends me for a STAT emergency MRI that day - Get MRI scans done at 8pm - Get a call personally from primary physician at 11:30pm saying one scan is inconclusive and sends me for an emergency CTB scan at the ER immediately 6/2/21: - Two CTB scans are completed at 2am - At 4am we are seen by doctor who admits me and says he wants to contact a neurologist specialist - Neurologist comes in at 8:30am and tells me I have been diagnosed with a rare mild blood clot in my brain - Put on Eliquis blood thinner for 6 months & ButalBital Acetaminophen for migraine pain relief 6/9/21: - Met with hematologist to go over blood test results, told I am a carrier for the Factor 2 Gene Mutation

After fully vaccinated, patient vacationed and had a negative test prior to return home (end of May). Early June, patient experienced burning chest pain & difficulty breathing. Found to be COVID positive, with elevated cardiac enzymes (troponin 0.45ng/mL). Echocardiogram showed pleural effusion, pleurisy, acute congestive right ventricular heart failure, possible myocarditis vs. severe pulmonary vascular edema, and scant pericardial effusion. Patient was transferred to hospital for higher level of care. Unknown if cardiac effects are related to vaccination or acute disease process.

flutter and AFIB; anxiety; threw up; her heart was racing; This is a spontaneous report from a contactable consumer (patient mother) reported patient (reporter daughter). A 22-year-old female patient received first dose of BNT162B2 (Pfizer covid-19 vaccine, Solution for Injection, Lot Number: EN6205, Expiration date: Unknown), via an unspecified route in the right arm on 07Apr2021 (age at vaccination: 22-year-old) as a single dose for covid-19 immunization. Medical history included extreme immune system and seizures that only lasted about 2 years when she was a baby. The patient concomitant medications were not reported. Patient had issues when she was born, she was 3 weeks post term, she was adopted and when all the kids would get sick, she would always get the sickest. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On an unknown date, few days later she felt something and thought it was anxiety, 2 weeks after vaccination from 15May2021, she woke herself up threw up and saying that her heart was racing around 8:30 in the morning, so she went and got their finger monitor, and her heart rate was out of control, so they took her to the emergency room. They tried to get her heart rate down with medications and sent us to an electro physicist, and the rest is history. Patient has been an athlete her whole life, has been in great shape with no heart problems. She was taken to the ER and they captured flutter on the EKG and AFIB issues. Later she was hospitalized and ended up having cardiac surgery about a week ago at 13:00 (16Jun2021 to 17Jun2021). Caller states that her daughter was doing really well, they had to do an ablation. Caller states they saw the cardiologist today, her daughter may have bouts of palpitations, but has had nothing since 3 days after the surgery. Caller wanted to know if AFIB has been reported as a reaction. She received her second shot of BNT162B2 (Pfizer covid-19 vaccine, Solution for Injection, Lot Number: EN6199) in the right arm on 28Apr2021. They said she will recover completely, but it will take about 3 months. She will have to be followed by a cardiologist. The patient underwent lab test and procedure on 15May2021 which included flutter on the EKG. The clinical outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.

Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Weakness-Severe, Additional Details: PT received vaccine and then felt light headed and began to panic. She was being assisted by pharmacist and shift supervisor when she stood up to attempt to walk into the vaccination booth to calm down. She passed out, flew forward hitting her forhead on the corner of the wall, she was momentarily unconcious and she had a cut on her forehead and was bleeding. Shift supervisor called 911 while pharmacist tended to her until emts arrived.Her parents were contacted and she was taken to er

The first dose I experienced flu symptoms with a body ache/chills/headache that lasted for about 2-3 days. 2nd dose, next day had a fever/chills/headache/body aches, a few days later experienced shortness in my breath, numbness, and pain in both legs, extreme lower back pain and abdominal pain/cramping and the pain is still there, I have 2 swollen lymph nodes located in my groin area. I have seen the Dr a few times and had a CT scan. They discovered I have an enlarged liver/swollen spleen that they found a blood clot, the doctor has me taking aspirin for 3 months, and will need to follow up with another CT scan

Thyroid or throat area was pounding; Thyroid or throat area is pounding; legs swelled up so bad; Heart rate very low; circulation issues; Felt like having a stroke; Dizzy; Pitting in left leg, which was pale and had veins showing; Pitting in left leg, which was pale and had veins showing; Pitting in left leg, which was pale and had veins showing; Struggling to breathe/can't breathe; Weak; This is a spontaneous report from a contactable consumer (patient). A 22-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the left arm, on 04May2021 12:00 (Batch/Lot Number: EL9269), as dose 1, single, at age 22 years old, for COVID-19 immunization, at a pharmacy/drug store. The patient was not pregnant at the time of vaccination. Medical history included Hashimoto's disease, Ehlers-Danlos syndrome, and Raynaud's disease, all from unknown dates, not reported if ongoing or not. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 since the vaccination. The patient received unspecified medications within 2 weeks of vaccination (unspecified concomitant medications). On 07May2021 (also reported as "around day 3 or day 4"), the patient started to get dizzy. On the same day, 07May2021, the patient felt like have a stroke because she could not make thoughts. She had pitting in left leg (also reported as "pitting in left left", pending clarification), which was pale and had veins showing, and she was struggling to breathe and was weak. On 09May2021 (also reported as "about day 5"), her heart rate was very low and she noticed circulation issues. On 11May2021 (also reported as "day 7"), her legs swelled up so bad. On 14May2021 (also reported as "day 10"), the patient's thyroid or throat area was pounding. The events resulted to emergency room and physician's office visits. Treatment for the events included turmeric and aspirin which the patient took every day, multiple times a day. Blood work on an unspecified date mostly came back normal. The patient reported the events were better in two weeks. Her physician advised her to skip the second dose. However, the patient received the second dose out of "fear of missing out" on 25May2021 12:00 (Batch/Lot Number: EW0178) in the left arm. The patient was recovering from the events. Follow-up attempts are completed. No further information is expected.

AFIB/flutter; threw up; Threw up and saying that her heart was racing/have bouts of palpitations/heart rate was out of control; This is a spontaneous report from a contactable consumer (patient's mother). A 22-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm right at age of 22 years on 28Apr2021 (lot number: EN6199) as single dose for covid-19 immunisation. Medical history included extreme immune system, described that patient was 3 weeks post term (as reported) and had issues when she was born, she was adopted and when all the kids would get sick she would always get the sickest; had seizures that only lasted about 2 years (not ongoing) when she was a baby. Family medical history relevant to AE was none. Concomitant medications were none. No vaccines administered on same date or within four weeks prior to the first administration date of the suspect vaccine. The patient previous took bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose1 via an unspecified route of administration, administered in arm right at age of 22 years on 07Apr2021 (Lot no: : EN6205) for covid-19 immunisation, few days later she felt something and thought it was anxiety. On 15May2021, 8:30 in the morning patient threw up and was saying that her heart was racing, so she got their finger monitor, and heart rate was out of control so they took her to the emergency room. They tried to get her heart rate down with medications and sent her to an electro physicist, and the rest was history. The only reason attributed this to the vaccine was because this occurred 17 days after her second shot and patient was has been an athlete her whole life, has been in great shape with no heart problems. They captured flutter on the EKG, and saw AFIB when she was under, on 15May2021. Patient ended up having to have cardiac surgery (for AFIB) on 16Jun2021 13:00 in hospital from 16Jun2021 to 17Jun2021. Patient was doing really well, they had to do an ablation. Patient will recover completely, but it will take about 3 months. She will have to be followed by a cardiologist. Saw the cardiologist, patient may have bouts of palpitations, but has had nothing since 3 days after the surgery (19Jun2021). The outcome of the events palpitations was recovered on 19Jun2021, other events was recovering. Follow-up actions are needed. Further information has been requested.

It took about 2.5 weeks for non-conclusive pulmonary embolisms to appear in both the right and left lungs

Presented to ED 1/3/2021 Tachycardia, fever, headache and myalgia. Complaints of shortness of breath.

Bleeding Upon injection Bruised skin lasting greater than 14 Days. Bruise at time of entry. Hardness on injection side lasting 14 days+ Soreness lasting 14+days

The shot went in my arm and I immediately started feeling itchy. Before the needle was out, I knew something was wrong but almost didn?t believe how fast it happened. My throat started itching and swelling shut. I was in full blown anaphylactic shock in less than 2 minutes. I got an EpiPen shot in the parking lot and was admitted into the hospital where I continued having various reactions. A week after the shot, I?m still breaking out in hives uncontrollably.

24 y.o. female with no significant past medical history who was diagnosed with COVID-19 (NP PCR on 1/27/2021) with mild symptoms (3-4 days of rhinorrhea and myalgia) and complete recovery with return to work who recently completed COVID-19 vaccine series (Pfizer 1/8/2021, 2/5/2021) now presenting for hospitalization (2/26/2021) with fever, rapidly progressive hypoxia, and hyperinflammatory state including elevated ESR, CRP, ferritin, D-dimer, and troponin (20) in the setting of positive COVID-19 NP PCR (2/26/2021) and positive S.pneumoniae urine ag with clinical diagnosis of MIS-A s/p high dose methylprednisolone and IVIG.

23 yo FM who received first dose of Pfizer vaccine and then was noted to have shortness of breath and complaining tongue closing sensation immediately after at Vaccine Clinic --I was called to evaluate the patient. When I arrived patient was laying down on a chair with a friend, shaking with seizure like activity but alert and oriented to person place and time. Upon my arrival she was shaking, vomited x 1 and then complained about chest pain. Vitals upon my arrival: HR 58, o2 100% RR appeared to be around 22-24 (hyperventilating) BP 88 systolic (manual)--repeated by medics upon arrival minutes later 110/72. Given throat closing sensation, vomiting, shortness of breath I advised to call 911 and ordered Epinephrine x 1 which was given by RN immediately. Pt was then placed on the grown chin up, she continued to shake throughout entire body but continued to be alert and oriented. Medics then arrived on seen, started an IV, glucose by medics 84, IVF started by medics. Pt was transported to ER via medics. Pt is not a patient, last visit 2017. Pt did state she has hx of POTS and DRESS syndrome to Lamictal. Reports taking cetirizine this AM, Zofran and Oxycodone and Baclofen (prescribed by external PCP?). Prior to transport to ER pt continued to be alert oriented, but shaking and twitching throughout her body. MD verbally communicated to patient to not receive the 2nd dose given her severe anaphylaxis like reaction to the first dose of the vaccine. Pt can be referred to allergist after ER follow up by PCP. Denied pregnancy.

Pt came on 4/9/2021 presenting c/ogeneralized fine pinpointed red rash (petechial), except on face since Tuesday 4/6/21, states that she gother first Pfizer COVID-19 vaccine on 4/5/2021. No itching. Patient had CBC, rapid strep, urine HCG, and COMP metabolic completed during clinic visit on 4/9/2021with results shown below including platelet count reported at 38. Labs ordered to be completed as sendout and pending results are RPR Dx w/Reflex - OS, PT w/Inr - OS, PTT, Activated - OS,Hemoglobin A1C - OS, CBC (includes Diff/Plt)-OS . Pt referred to ER for further evaluation.

Hospital course: 23 yo female with no significant PMH presenting to the ED with right sided CP, worse with deep inspiration. Received 2nd covid vaccination last week- mild reaction with fever thereafter. She had w/u in the ED including an EKG with inferior and septal TWI and trop of 1.61. CTA chest was negative. She was admitted. After admit, troponin trended up (1.61--3.71--4.93). CRP 49.1, ESR 21. Echo showed apex hypokinesis so with TWI on EKG and elevated trop, cardiology elected for LHC. This was normal. Cardiac MRI showed myopericarditis. She was started on high dose ASA, colchicine and bblocker for this. Likely viral etiology (Covid, Resp 4 plex negative). Trop trended down on 4/13 (CRP still rising). Cardiology was ok with discharge. Will need 2 weeks of ASA and 3 months of colchicine. No strenuous activities for that time frame. She is getting her Masters in music/violin and did not need a return to school note. Feeling somewhat better at discharge- rated pain 6/10. Internal Medicine followup in 1 week Cardiology followup in 2 months

Dyspnea and pleuritic chest pain onset 4/22-23, prompting presentation to ED. Found in ED on 4/24 to have central R pulmonary embolus extending into interlobar, segmental, subsegmental branches of RUL & RLL, mild R heart enlargement without evidence to suggest RH strain, and mild pneumomediastinum most notable at the thoracic inlet. Tolerating RA. Started on AC with heparin drip, transitioned to xarelto at discharge.

Menstrual cycle heavy blood clots - my next cycle after the first dose of covid vaccine which I received on 4/14, my period flow was comprised of 2 inch blood clots which I passed for an hour on 4/27. I haven?t passed period blood clots this large since I was 12 years old so I wanted to report it since I happened to get these unusual blood clots the cycle after I got the first dose. I am getting the second dose on 5/5 so I will see if the same results take place. I have reported this to my gynecologist but am waiting on her response.

I started my period on Tuesday (which has always been incredibly regular and predictable for 5+ years while being on birth control). I have been experiencing heavier bleeding and more clotting than average. My cramps are also worse. This never happens to me, and it only makes sense due to the vaccine. I would like there to be some organization that looks into this because I have not changed anything in my life for this to be happening.

My period flow have constantly been pretty normal. But this cycle I am have extremely heavy flowing and a lot of blood clots. I normally never have these.

A day after the vaccine I had ringing in my left ear which lasted for two days and then went away. Today, about ten days after receiving my second vaccine, I started experiencing cramps and vaginal spotting about five days before my next scheduled period, which is normally very regular.

vagina bleeding before menstruation; This is a spontaneous report from a non-contactable consumer (patient). A 23-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, into left arm on 04May2021 (at the age of 23-year-old) as 2nd dose, single for COVID-19 immunisation. Medical history included pumpkin allergy. Patient was not pregnant. Concomitant medication includes generic oral contraceptives. Historical vaccine includes first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) into left arm on 15Apr2021 (at the age of 23-year-old) for COVID-19 immunization and experienced random episodes of dizziness about once per week. On an unspecified date after the administration of the 2nd dose, patient experienced vagina bleeding before menstruation. The patient did not receive treatment for the event reported. The patient underwent lab tests and procedures which included SARS-CoV-2 test (nasal swab): negative on 19Apr2021, negative on 26Apr2021 and negative on 03May2021. Outcome of event was not recovered. No follow up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Pt presented to ED at apx 1pm on 5/28/21 with signs of anaphylaxis. Swollen upper and lower lips, sensation of swollen throat, and facial swelling, with urticarial lesions to upper chest wall and arms. No GI symptoms. No hypotension. Received 0.3mg IM epinephrine, 50mg IV benadryl, 125mg IV solumedrol, and 20mg IV pepcid. Symptoms slowly resolved over 3-4 hours. Pt could not recall any other now inciting event or product other than vaccine she had yesterday around 4pm. No reaction to first pfizer vaccine noted.

Went into ER with leg pain the night of 5/14. Admitted into ICU 5/15 for deep venous thrombosis in the leg and pulmonary embolisms in the lungs. Symptoms in leg started a few days prior to admittance. Was put on Heparin via shot and then IV. Clotting grew worse overnight with leg swelling, leading to an inability to walk. After increased elevation leg improved and was put on an oral dose of Eliquis. Was put on oxygen in the ICU and took portable oxygen home when discharged on 5/17. Also tested positive for strep 4/11. Was advised to file a report by my PCP.

4/30 - Five minutes after the vaccine, I passed out. I felt uncontrollably shaky and my vision went white. I was not anxious prior to getting the vaccine and felt terror afterwards. 5/1 - I developed severe depression and suicidal ideation. I reported to those around me that I did not feel safe. I am not diagnosed with depression and did not experience depression prior to the vaccine. I felt suicidal, completely hopeless, anxious, and was uncontrollably bursting into tears without an identifiable trigger. 5/2 - I developed shooting pain in my legs and arms. It felt like a pulsating, stabbing pain that throbbed. It was unlike any pain I had experienced ever before. 5/3 - I developed a metallic taste in my mouth that could not be washed away with water or food. It was extremely noticeable. 5/4 - My period came a week early. I have been on birth control for seven years and have never experienced any changes in my menstrual cycle. I made no other lifestyle or health changes other than the vaccine. The period was extremely heavy, full of clots, and was painful. It lasted longer than usual, until about 5/9. 5/16 - I developed another period only a week after the first period. This period was equally as heavy and long-lasting. It remained until about 5/21. Following the vaccine, I began suffering from heart palpitations, leg cramps, and random pains. I did not experience these prior to the vaccine. I cannot identify the date these symptoms began, but it was within the first week of taking the vaccine.

2/23 vaccination Within 12 hours, I started shaking, spiked fever, HR increase, SOB, out of body experience, scary experience. Called 911 transported to ER. Monitored cardiac unit for 24 hours, HA. Two months of HAs. I went home and I don't recall exact how everything transpired. I do remember they wanted follow up with PCP. I developed blood clots in R arm, platelets were high since getting vaccinated. *originally diagnosed with colitis but now diagnosed with Chrohns disease. 1/16 I did have a personal injury in a parking lot that exacerbated the issues, I was vaccinated after. *In transition with new doctors now and have not really discussed the potential of this being caused by vaccine, focused more on pain management. **before this vaccine, I was relatively healthy before, no issues.

About three days after vaccine, I started bleeding and getting blood clots. I went to ER to make sure I wasn't miscarrying. I wasn't that day. Everything looked okay. Baby was measuring much smaller than it should be. I kept bleeding lightly for a couple of days. Tuesday I was bleeding heavily - I went to ER again. Hormone levels - were going up but not as they should be. From Tuesday - Friday, I didn't bleed. I started bleeding on Saturday again. And I'm still bleeding. I called my OB today and she is going to call me back in the morning to let me know what to do. I was last seen on Friday at ER again. Pregnancy History - One other pregnancy - carried twins fine. Estimated date of delivery for this pregnancy - January 17, 2022.

suffered a PE; This is a spontaneous report from a non-contactable consumer via a sales representative. A 23-years-old female patient received second dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine), at the age of 23-years-old, via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. Medical history included hereditary gene disorder with lupus. The patient's concomitant medications were not reported. The patient experienced suffered a PE (pulmonary embolism) on an unspecified date with outcome of unknown. Her team of physicians treating her acutely, did not feel it was attributed to the vaccine and rather due to a hereditary gene disorder with lupus. Event took place after use of product. No follow-up attempts are possible. Information about lot/batch number cannot be obtained.

Felt dizzy, faint, and hot after 2nd vaccine. Nurse sat with her until she felt better. 5/14/21, she had an acute ischemic stroke. Many tests ran during 4 day hospital stay including CT scan, MRI, several blood tests, echocardiogram, TEE heart test. Discovered vegetation in heart that they decided must have broken off and caused the stroke that killed about a third of the right side of her brain and there was one time spot on the left side of her brain. Had loss of strength and mobility in upper left side of body (mainly left hand and left side of face). Discharge papers gave diagnosis of acute ischemic stroke and Libman Sacks endocarditis. Blood tests have shown that there was no infection that caused problems. Have been unable to determine cause.

Approximately 1 week after my second dose of the Pfizer-BioNTech COVID-19 vaccine on May 1st I started experiencing right calf pain. On May 11th, I was diagnosed with a DVT in that same calf.; Approximately 1 week after my second dose of the Pfizer-BioNTech COVID-19 vaccine on May 1st I started experiencing right calf pain. On May 11th, I was diagnosed with a DVT in that same calf. I was ad; This is a spontaneous report from a contactable consumer (patient). A 23-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Lot Number: EW0172) via an unspecified route of administration on 24Apr2021 (at the age of 23-year-old), as dose 2, single in right arm for COVID-19 immunization. The patient's medical history included migraine, anxiety, and panic attack from an unknown date and unknown if ongoing. Concomitant medication included alprazolam (XANAX), paracetamol (TYLENOL), ethinylestradiol, norethisterone acetate (JUNEL) and Keto Karma Fat Burn Red; all taken for unspecified indications, start and stop dates were not reported. The patient previously took Aimovig and experienced drug allergy. The patient's historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Lot Number: ER8734) via an unspecified route of administration on 02Apr2021 (at the age of 23-year-old), as single dose in right arm for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 01May2021 at 17:00, 7 days and 17 hours (approximately 1 week) after the administration of the second dose of vaccine, the patient experienced right calf pain. On May 11th, 17 days after the administration of the second dose of vaccine, the patient was diagnosed with a deep vein thrombosis (DVT) in that same calf. Adverse events resulted in Emergency Room visit and Physician Office Visit. Treatment medication included blood thinners. The patient had no COVID prior vaccination and was not tested COVID post vaccination. The clinical outcome for the events was resolving Information about lot/batch number was provided. Additional information has been requested. Follow-up attempts are completed. No further information is expected.

Excessive bleeding in the vaginal area and what looks like skin like shedding/mucus shedding; Excessive bleeding in the vaginal area and what looks like skin like shedding/mucus shedding; This is a spontaneous report from a contactable consumer (patient). A 23-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 06Jun2021 17:00 (Batch/Lot Number: EWO177), age at vaccination of 23-years-old, as single dose,for covid-19 immunisation. Medical history was none. The patient was not pregnant and was not pregnant at the time of vaccination. The patient had no allergy. Concomitant medications included lisdexamfetamine mesilate (VYVANSE) taken for an unspecified indication, start and stop date were not reported; ethinylestradiol, norgestimate (ESTARYLLA) 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. The patient experienced excessive bleeding in the vaginal area and what looks like skin like shedding/mucus shedding on 07Jun2021 11:00 AM. No treatments were given for the events. Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store. 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 was not recovered from the events.

Patient received first vaccine 5/9/2021 Reported unscheduled vaginal bleeding and severe cramping 5/10/2021 Lost to follow-up after second dose

Anaphylaxis. The COVID shot was given, no reaction then. After 7 minutes, congestion, severe cough, vomiting phlegm, feeling like throat closing started happening. Code was called, Benadryl was immediately given intramuscular in the left arm, blood pressure, pulse ox was taken, and then was taken to the Emergency Department. In the ED, I was given prednisone, one EPI, anti-nausea medication all through I.V. and many more medications given to me via I.V. that I don't sincerely remember. I was under observation for 4 hours. I was discharged after all symptoms dissipated and was given Prednisone 20 MG (3 tabs a day) to take to help my lungs. Management followed up almost immediately, everyone from the moment I had the anaphylactic reaction was quick and prepared.

Patient received Pfizer vaccinations on 12/29/20 and 1/19/21. She woke up on 1/20 with hot flashes, fatigue and chills. Later in the day she developed a headache. This morning (1/22) as she was walking to her car to go to work she developed dyspnea and palpitations. She had a portable pulse ox and noted HR was 125 and PO2 97%. She went to ED, COVID neg, d-dimer positive, CT chest negative for PE. Potassium was low. Patient was discharged home.

Anaphylaxis - Throat swelled almost completely closed, wheezing, lightheadedness (nearly passed out), throat/neck and injection site were very itchy and swollen, face/eyes swelled up, turned very pale all over, heart palpitations, etc. The next day - severe, horribly painful burning sensation all throughout my body. Even clothing lightly touching my skin felt like hot razors cutting in to me. Residual swelling of the face/ arm. Migraine. For two weeks after - Very large, hard lump under my skin at the injection site. It was about the size of my hand and was very painful. After a few weeks it went away. Treatment- large amounts of benadryl. The pharmacist wanted to use an epipen and send me to the hospital, but I refused because I could still get some air in (doctor later told me that my reaction was so severe I should have gone to the hospital). I had to keep taking large amounts of benadryl for the next few days to keep the reaction down a bit.

Bilateral pulmonary embolism. No clots detected in legs. Treatment: removed from birth control, Eliquis (10mg) for 3 months

Grand mal seizure 23 minutes after receiving 1st dose of vaccine. Managed by parents. (Error on date. It was given on 3/21/21 not 3/20/21. Typo)

About an hour after receiving the vaccine I was lightheaded, nauseated and my tongue began to get itchy and swollen like the beginning of an anaphylactic reaction. I took some Benadryl and Pepcid like I would for an allergic reaction. Then I went to urgent care. While I was waiting to see the doctor at urgent care my throat began to spasm and tighten and I had trouble breathing, this was about two hours after I got my vaccine. I was given a steroid and a muscle relaxant. My throat was quite sore for a few days after, but besides that I felt much better after I was given the steroid and muscle relaxer

3/23 developed chest tightness with shortness of breath 3/26 dry cough 3/30 +D-Dimer 14,103. CT showing pulmonary emboli right main pulmonary artery and left lower lobar artery.

nausea, vomiting, weakness and malaise, diffuse body rash presented to ER with rash, platelets 94 and right upper lobe pneumonia tested negative in ER for COVID

24 yo female who presents to the ED for concern for anaphylaxis after receiving her second dose of the COVID-19 vaccine. Patients presents as a rapid response after receiving Epi pen to her thigh at 11:18AM. She reports that after getting the vaccine, she was sitting in the monitoring area. At the 10 min mark she noted that she had a slight cough and some eye tearing. She went to the bathroom and noticed that her eyes were swollen and she could barely open them. Someone told her that her lip looked swollen but she did not look at it in the bathroom. She also felt some throat tightness but no wheezing. She had nausea prior to vaccine, no vomiting. She had no lightheadedness or palpitations and no itching or rash anywhere. She got an Epipen at 11:18AM. A rapid response was called and she was brought to the ED. She has no personal or family history of allergic reactions and no known allergies.

Severe Vascular Thrombosis (vomit, loss of balance, numbness in arms and legs, lost of speech, impaired vision) had to be hospitalized for 4 days, and had some brain damage from the thrombosis.

Anaphylaxis; Lightheaded/Dizziness; Throat Swelling; Scratchy Throat; This is a spontaneous report from a contactable consumer (patient). A 24-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EP6955), via an unspecified route of administration, administered in left arm on 12Apr2021 at 09:30 (at 24-year-old, not pregnant at the time of vaccination) at single dose for COVID-19 immunisation. Medical history included known allergies: tree nuts. The patient had Covid-19 prior vaccination. The patient's concomitant medications were not reported. No other vaccine was received in four weeks. No other medications were received in two weeks. On 12Apr2021 at 10:00 AM, the patient experienced anaphylaxis; lightheaded/dizziness; scratchy throat; throat swelling. The events 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 the events included epinephrine and steroids to prevent swelling. The outcome of the events was recovered on an unspecified date in Apr2021. The patient did not have covid test post vaccination.

2 days after receiving first dose Pfizer Covid-19 vaccination, developed vaginal bleeding that has persisted for 10 days. Is on birth control pills and has been taking regularly. Bleeding described as darker red in color and flow about same as first day of normal cycle. Is on 3rd week of active pills. Urine pregnancy test done 4/20/2021 negative. Checking CBC today.

A week later, I had an anaphylactic reaction to a kit kat bar. I had previously ate kit kats with no issue. I had to be intubated and hospitalized. After extubation, I continued to have anaphylaxis at least once a day with no correlation to what I was eating or drinking. I also began having a severe auto immune flare up with body pains in my legs, back, and stomach immobilizing me with generalized weakness.

Blood Clot formed in lung; cough; This is a spontaneous report from a contactable consumer (patient). A 24-year-old female patient received BNT162B2 (lot number: EL3246) second dose on 10Feb2021 (24-year-old) on left arm at single dose for COVID-19 immunisation. Medical history included Hypothyroidism. Patient had allergy to Hydrocodone, Oxycodone and Acyclovir. Patient is not pregnant. No covid prior vaccination. Concomitant medications included sertraline and levothyroxine. No other vaccine in four weeks. Historical vaccine included bnt162b2 (lot number: EL3246) on 16Jan2021 09:00 AM (vaccinate age 24 years old) first dose on left arm for covid-19 immunization. Facility type vaccine was Hospital. Patient had Blood Clot formed in lung on 17Feb2021 12:00 AM and cough a week in Feb2021 after second shot. Event resulted in Emergency room/department or urgent care, Life threatening illness (immediate risk of death from the event)]. Patient received Medication as treatment. The outcome of events was Recovered with lasting effects. No covid tested post vaccination.

I have only gotten the first shot so far. I got the shot last Sunday and then on the following Tuesday I went to donate plasma. I frequently donate plasma. I had no side effects from the shot up until that point. Immediately after donating, I got in my car and looked down to see that my needle injection site from donating was pouring out an excessive amount of blood. I lost all vision and the employees helped to rebandage the site and put pressure. That had never happened before after donating. It seemed that my blood failed to clot.

During the post-vaccination observation, patient started to feel weak and turn pale. Our pharmacy brought patient back to the pharmacist in the immunization. She began to experience the anaphylactic reaction and a dose of Epipen 0.3mg was given to patient by the pharmacist. The pharmacist called 911 and after a few minutes patient started to feel better and and skin turned back to normal. Pharmacist continued to observed patient until paramedic team arrived.

Received her first dose Pfizer vaccine (LOT#: EW0173 EXP: 8/2021) at 1009 on 5/02/21. PHN was alerted by EMT who was told by patient that vaccinator made her anxious about the vaccine. Patient stated that vaccinator told her she was bleeding more than usual and that there was a small bump on her arm. EMT contacted patient at 1015. Patient reported swelling and hematoma at injection site. At 1025 patient reported feeling anxious and was crying. PHN assessed patient and reassured her the swelling in her arm was going down. PHN educated patient on worsening signs and symptoms at injection site and treatment of swelling. Patient verbalized understanding. PHN asked EMT to take vital signs. EMT took patients vital signs at 1033. BP: 140/111, pulse: 72, RR: 20. EMT reassessed patient at 1040. Patient stated that she was feeling a lot better and less anxious. EMT retook patients vital signs at 1042. BP: 142/108, pulse: 66, RR: 20. Patient had completed her observation time. Patient left at 1045 by herself, unassisted with a steady gait.

Assessment Differential Diagnoses URI, bronchitis, bronchiolitis, allergic rhinitis, atypical pneumonia, community-acquired pneumonia, asthma exacerbation, COPD exacerbation Red Flag Symptoms Shortness of breath, fever, chest tightness, chest pain, palpitations, wheezing Subjective Chief Complaint Headache and myalgias HPI via Virtual visit 24 year old female complains of COVID-19. Patient is a nurse at the hospital. Yesterday, she developed a headache along with neck and shoulders achiness. Last night, she came home with no appetite, has pressure in her chest. Feels tight and makes her cough. She has had 1 dose of of the covid vaccine. Denies fever. Has no headache currently. She has not taken anything.

still didn't feel good; slight fever it was 102; throwing up; anaphylactic allergies, and swell up like her throat, neck and face swelled a little bit; Cold and flu symptoms; Cold and flu symptoms; her arm was really killing her; This is a spontaneous report from a contactable consumer (patient). A 24-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 05May2021 (Lot Number: EW0167) as single dose for covid-19 immunisation. Medical history included weird blood pressure (kind of have weird blood pressure, it goes up and down pretty frequently, no treatment), endometriosis, seizure. Concomitant medications included lamotrigine (LAMOTRIGINE) taken for seizure; quetiapine. The patient had an adverse reaction to the first of the two vaccine shot and wanted to know if she can get the second. She had pretty bad cold and flu symptoms and did have anaphylactic allergies, and swell up like her throat, neck and face swelled a little bit on 06May2021. It wasn't enough to go to the emergency room. She took Benadryl and kind of monitored but she thought her doctor would have called it like a pre-anaphylactic sort of reaction. The patient was having the reactions on yesterday (06May2021), still didn't feel good today (07May2021). She started to swell up she took Benadryl and Tylenol because she had slight fever it was 102 (06May2021). So, Tylenol 400 mg (took 2 pills), took 600 mg of Ibuprofen and the Benadryl 200 (200 but not entirely sure). She tried not to take medication unless have to, the moment she started throwing up she took the Benadryl only took that once, her arm was really killing her so she did take the Ibuprofen twice yesterday (06May2021) and twice Wednesday (05May2021). The fever came back yesterday (06May2021). Tylenol, probably the same twice on Wednesday, twice on Thursday, the patient hadn't had to take any today (07May2021). The outcome of events was not recovered.

Patient had two tonic-clonic seizures 8 hours apart and was unconscious for up to 10 minutes. Seizures were closed eye seizures that started upon falling asleep. Patient had no prior history of seizures before the vaccine. Both times patient was transported via Emergency Paramedics to ER.

Patient presented for 2nd dose and reported having a blood clot the day after receiving her first dose. She is unsure if it was due to the vaccine or her vascular malformation. She did not seek medical help or receive a diagnosis from a medical professional. States the clot dissolved on its own. Pfizer Covid vaccine

massive blood clot from her thigh to her ankle; incapable of walking; serious pain in my left thigh/muscle strain; serious pain in my left thigh/muscle strain; leg fell asleep; This is a spontaneous report from a contactable consumer (patient). A 24-year-old female patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number and expiry date unknown), via an unspecified route of administration, administered in the left arm on 11May2021 at 14:45 as a single dose for COVID-19 immunization. The patient's medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient was taking unspecified birth control medication. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was on her second week of completing the vaccine. The patient reported that on Thursday night, 20May2021, she was just laying down on her couch watching Netflix with her laptop on her lap, her leg fell asleep but she didn't think anything of it because once she started walking around it went back fine. However, on 21May2021, Friday morning, she was having serious pain in her left thigh. She believed it was a muscle strain. The patient did a cold compress, warm bath and took Tylenol from Friday to Saturday. She thought it got better but by 23May2021, Sunday night, she was incapable of walking on her own and needed assistance just to go to the bathroom. On 24May2021, she went to Urgent Care and they stated that she may have a blood clot so she went to the ER (Emergency Room). While at the ER they said she had a massive blood clot from her thigh to her ankle. She would need a procedure done to remove it and was later admitted into the hospital and scheduled for the procedure. Blood thinners and suctioning out the blood clot was done as treatment. The patient been tested for COVID-19 (nasal swab) on 24May2021 with a result of negative. The outcome of the events was unknown.

On Day 2 after the vaccine I started my menstrual cycle a week early. I am never early. I had cramps, breast tenderness, and began bleeding.

Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Severe, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Tingling (specify: facial area, extemities)-Severe

Vasovagal syncope, code blue called, patient regained consciousness and did not require further treatment. Patient did not visit ED. Patient did report after vasovagal episode that they typically respond like this after administration.

transient ischemic attack I was working and felt unusually exhausted, lost vision in my right eye for over an hour, and called my boyfriend to tell him I wasn't feeling well and that I would try to make it through my work shift. I then called him back 4 minutes later and failed to form words, and also could not type words. I felt like I was going to faint and have no recollection of 10 minutes during that time. I had to leave work to go to the emergency room. I had a massive headache for 3 days following my TIA.

I started having cramps Friday night and Saturday morning I started bleeding, by Saturday evening I was passing clots and tissue. ER doctor and nurses did tests and found I was having a miscarriage.

Mild anaphylaxis less than 5 min after injection. Symptoms onset immediately, including dizziness, rapid heart rate, tightening of the throat, making breathing/swallowing difficult, ears felt strong pressure/itch. Symptoms went away on their own, but several episodes of similar symptoms/intensity persisted throughout the evening roughly every 30min-1hour.

Patient developed rapid onset of dyspnea, light headedness and tachycardia. Was taken to the ED where she was treated with an antihistamine and IV fluids. Symptoms resolved. 6 days after the vaccine, was having shortness of breath and left arm pain (not the arm where injection was received) and was diagnosed with a pulmonary embolism.

Instant bleeding, hematoma, pink around injection site, and lump. The next day there is purple bruising that has expanded and the injection site is warm to the touch. It is mildly painful in that region as well as to move my left shoulder. There is also a lump in that area.

Gran mal seizure 19 days after first dose. First ever seizure I have ever had; it occurred in the middle of the night. All bloodwork, CT, MRI, and EEG studies were WNL.

Anaphylaxis, Urticaria Patient was transferred to the Emergency Room @ 14:14 via EMS,After 1st vaccination patient experienced tingling of the tongue. After 3 mins of observation patient began to have hives around her neck. Epi was given 14:07 lot# 9fm640. Exp apr 2021 Vital Anaphylaxis

I had my period last week. The day after my vaccine, my vagina kept bleeding on and off. The consistency of the blood was much thinner than what I generally experience during my period. On the second day after, I am currently experiencing occasional pain in my genital area. This is embarrassing for me to write but I know others who have experienced similar side effects. For this reason, I feel the need to voice this side effect.

Pulmonary Embolism: presented with chest pain and shortness of breath found to have pulmonary embolism on CT angiogram. Symptoms resolved after 3 weeks of anticoagulation. No evidence of DVT.

I am currently 5 weeks 4 days pregnant with one previous miscarriage. This pregnancy is due on Dec. 12th. It might be a coincidence but the same day I got my 2nd dose, I started to spot in the same way I did with the previous pregnancy that ended in miscarriage which didn?t happen until 9 weeks.

started spotting blood; A few hours after i had an unbearable headache that was not relieved until I took 800mg of ibuprofen and then 1000mg of Tylenol an hour later at about 1am; Full body aches; exhaustion; menstrual like cramps for several days; This is a spontaneous report from a contactable consumer (patient), who is also an other Health Professional. A 25-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of , administration, at age of 25 years, administered in Arm Left on 30Mar2021 11:00 (Lot Number: EP7534) at single for covid-19 immunisation. Medical history included Hashimotos , adhd (as reported), allergies to: Latex, corn, mint, morphine , beets, tobacco. Concomitant medication(s) in two weeks included lisdexamfetamine mesilate (VYVANSE), levothyroxine, liothyronine (NP THYROID) and levocetirizine dihydrochloride (XYZAL), all taken for an unspecified indication, start and stop date were not reported. Reported that "A few hours after i had an unbearable headache that was not relieved until I took 800mg of ibuprofen and then 1000mg of Tylenol an hour later at about 1am. Full body aches and exhaustion. I also got menstrual like cramps for several days. Now I just started spotting blood when my period finished two days before I received my vaccine, which is extremely abnormal for me." Events onset date reported as 30Mar2021 15:00. Treatment drugs received for event headache, and no treatment received for other adverse events, The patient was not diagnosed with COVID-19 prior to vaccination, and Since the vaccination, the patient has not been tested for COVID-19. Outcome for events was recovering. No follow-up attempts possible. No further information expected.

Period began a week earlier than usual and thus far as been very heavy with additional clotting. So far I am on day 3 of this period and had to change my cup 4 times throughout the night where I usually only need to change it once or twice. As I am very anemic this is concerning.

Headache after a few hours she experienced lower abd pain, cramps, nausea and for one day experienced vaginal discharge and bleeding, unrelated to her menses. She did not call her PCP or go to the urgent care, she decided to rest and monitor herself, she did take 400mg Motrin for the headache stated that most of the adverse reactions have resolved except for the nausea and cramps. RN recommended rest, light meals such as soup and lots of fluids and to continue to monitor herself and if these sx continue to make an appt with her PCP for further evaluation. She was agreeable.

Patient had abnormal vaginal bleeding the same day of administration of the 2nd Pfizer vaccine. patient's mother stated the bleeding was heavier than patient's normal menstrual bleeding.

Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Allergic: Rash Generalized-Mild, Systemic: Chills-Severe, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hyperventilation-Mild, Systemic: Nausea-Mild, Systemic: Shakiness-Severe, Systemic: Weakness-Mild, Additional Details: Patient recieved vaccination. 15 minutes later patient stated she wanted to stay a little longer with a feeling of uneasiness and muscle trembling/shaking and feeling cold. 27 minutes later patient stated she felt a sudden tightness in her chest and a shortness of breathing. Patient requested to get an epi-pen injection due to the difficulty in breathing. Patient had epi-pen injected into left thigh at 4:46 pm .

anaphylactic reaction; This is a spontaneous report from a contactable nurse (patient). A 25-year-old female patient received the second dose of bnt162b2 (Lot Number: En6203), via an unspecified route of administration, administered in right arm on an unspecified date (at the age of 25-year-old) as single dose for COVID-19 immunization. The patient is not pregnant. Medical history included COVID prior vaccination on unspecified date. The patient had no known allergies. Concomitant medication included unspecified birth control pills. The patient previously received the first dose of bnt162b2 (Lot Number: En9581) in the right arm on 09Feb2021 at 02:00 PM (at the age of 25-year-old) as single dose for COVID-19 immunization. No other vaccine in four weeks. On 21Mar2021 at 14:00 after her second vaccine the patient had an anaphylactic reaction. It was something she had eaten before so not new to her body. It happened again on 27Apr2021. Still from things she eats normally. Both occurrences happened 30 minutes after eating and came on quickly. The event 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 the event which included Benedryl, steroids, and given an epipen. The patient recovered from the event on unspecified date.; Sender's Comments: Based on the information provided, known drug safety profile and plausible temporal association, the causality between the suspect drug and the event cannot be excluded.

Pt is 25 yo female who received the first dose of the Pfizer COVID-19 vaccine in March 2021 developed diffuse petechiae and oral bleeding approximately 3 weeks after the vaccine and went to her PCP's office and labwork revealed a platelet count of ~15k cells/mm3. She went to the emergency department at Medical Center and was diagnosed with ITP by a hematologist who recommended that she not receive the second covid vaccine given the risks outweigh the benefits with her new diagnosis/possible reaction to the vaccine. She was treated with IVIG and prescribed corticosteroids and discharged. Two weeks later she was visiting friends in another city and developed a severe headache. She presented to our facility and was found to have a subdural hematoma on imaging and a platelet count of 9k cells/mm3. She was aggressively treated for her ITP with high dose IVIG, romiplostim, and rituximab and has stabilized neurologically with the SDH stable - though her platelets have been treatment refractory despite transfusions and the aforementioned therapy. Remains admitted at our facility.

Significant change in menses. Typically cycles once every three months with continuous birth control use. Menses in January (after first vaccination) was significantly heavier with passage of clots.

This 25 year old white female received the Covid shot on 1/26/21 and went to the ED on 2/26/21 with the following diagnoses listed below. The patient was under the care of an OB/GYN. It is unknown if this patient was pregnant and would need further investigation. N93.9 - Abnormal uterine and vaginal bleeding, unspecified.

Premature menstruation post-vaccination. Started evening of first dose. Have been spotting/bleeding for going on 20 days. Am scheduled to receive my second Pfizer-Biontech vaccination tomorrow, Tuesday, May 11th 2021 at 9:50 am. Will file secondary VAERS report if bleeding continues after second dose.

N93.9 - Abnormal uterine and vaginal bleeding, unspecified unknown if pregnant please request additional information for a chart review if needed

Abnormal bleeding in pregnancy. I was 8 wks at the time of injection. At 10+4 I had unprovoked moderately brisk vaginal bleeding (bright red) which lasted approximately 2hr followed by approximately 3wks of dark brown spotting. No etiology was ever determined. No other complications in pregnancy, estimated delivery date is 10/24/21.

About 10 hours after I received the vaccine I felt my heart racing, then I felt dizzy, and I fainted. My friend who was with me stated I stopped breathing. I was gasping for air and I turned blue. * I am healthy and never had any health issues*

patient has history of seizures, presented with a seizure to ED, she was nonverbal, diagnosed with unspecified convulsions and pseudoseizures. Patient was intubated. diagnosed with seizures and acute respiratory failure.

Patient presented to hospital with headache 6/21/21. CT head with contrast showed 1. Sinus thrombosis suspected in the patient's sigmoid and transverse right sinus. 2. No venous infarction or other acute finding identified. MRA neck showed thrombosis of right jugular vein and right sigmoid sinus. Patient started on heparin drip. Transitioned to Eliquis by neurologist and hospitalist. Remains hospitalized at this time.

vaginal bleeding; This is a spontaneous report from a contactable consumer reporting for herself. A 25-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: EN6201; Expiration date was not reported), via an unspecified route of administration, administered in Arm Left on 16Feb2021 14:30 (at the age of 25-years-old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history and concomitant medications included none. The patient experienced vaginal bleeding on 17Feb2021. The patient underwent lab tests and procedures which included TB skin test with unknown result on 10Feb2021. It was reported that patient had a TB skin test last Wednesday at the time of this report. Caller received vaccine and then on morning of this report, had some vaginal bleeding. She wanted to know if this was a reported side effect. The patient was taking Pfizer-BioNTech as she works in a healthcare facility and stated she was a receptionist and does the billing. She got the first dose of the Pfizer BioNTech vaccine the day before this report. On 17Feb2021, the day of this report, she went to the restroom. And when she wiped, she had blood coming out. She has had her menstrual cycle this month. She was unsure if this was a side effect or if she needed to go get checked out. Physician address, phone and email are unknown to caller. There was one little spot on the pad. The blood comes out when she wipes. It was red in color. History of all previous immunization with the Pfizer vaccine considered as suspect and additional vaccines administered on same date of the Pfizer Suspect, investigation assessment or relevant Tests included none. AE did not require a visit to Emergency Room or Physician Office. Outcome of the event was not recovered and ongoing at the time of this report. Follow-up attempts completed. No further information expected.

Patient came in after having two tonic-clonic seizures at work. Had been vomiting, having diarrhea, and feeling off. Vision was blurry on the way to work. BG was less than 20. Had seizure in 2019. So far Ativan has been ordered PRN for seizures and neurology to see pt for full workup.