Pfizer

Lips swelled and went numb. Hands swelled and went numb. Rash/redness covering upper body. Hives on arms. Nasal passages clogged

Left axillary, supraclavicual, and cervical chain lymphadenopathy > 1-week post-injection.; since the vaccination, has the patient been tested for COVID-19?: Yes; since the vaccination, has the patient been tested for COVID-19?: Yes; This is a spontaneous report from a contactable healthcare professional. A 26-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), intramuscular on the left arm on 21Dec2020 20:00 at single dose for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced left axillary, supraclavicual, and cervical chain lymphadenopathy > 1-week post-injection on 22Dec2020 16:00. in which the patient received no treatment. It was also reported on Dec2020, "since the vaccination, has the patient been tested for COVID-19?: Yes". The patient has other pending test. The outcome of left axillary, supraclavicual, and cervical chain lymphadenopathy > 1-week post-injection was not recovered and other events was unknown.; Sender's Comments: Based on the information provided, the COVID-19 test positive are possibly related to drug ineffective of BNT162B2 vaccine.

Allergic reaction resulting in full body hives, swollen hands, eyelids and lips; Allergic reaction resulting in full body hives, swollen hands, eyelids and lips; Allergic reaction resulting in full body hives, swollen hands, eyelids and lips; Allergic reaction resulting in full body hives, swollen hands, eyelids and lips; Allergic reaction resulting in full body hives, swollen hands, eyelids and lips; This is a spontaneous report from a contactable other health professional (patient). A 27-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were unknown) at the age of 26 years old, via intramuscular route in the left arm, on 10Jan2021 at 13:00, at a single dose, for COVID-19 immunization. Medical history included high blood pressure. The patient's concomitant medications were not reported. The patient has no known allergies. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in the hospital. On 12Jan2021, at 07:30 A.M., the patient experienced allergic reaction resulting in full body hives, swollen hands, eyelids and lips. The patient did not receive treatment for the events. Outcome of the events was recovering. The patient has not been tested for COVID-19 since vaccination. Information on the lot/batch number has been requested.

Sore arm at injection site; cold sore; Sore throat; This is a spontaneous report from a non-contactable Pharmacist(patient). The 26-year-old male patient received first dose BNT162B2(Covid 19, lot EK5730), via an unspecified route of administration at left arm on 28Dec2020 17:15 at single dose for COVID-19 immunization in hospital. Medical history included last cold sore was over 2 years ago. There was no other vaccine in four weeks. There was no known allergies, no other medical history. There were no concomitant medications. The patient experienced sore throat occurred 2 days after vaccination(30Dec2020), sore arm at injection site, cold sore appearance 8 days after vaccination, both on 05Jan2021. There was no treatment. There was no covid prior vaccination, covid tested post vaccination was Nasal Swab with PCR on 08Jan2021 with negative result. Outcome of events was recovered in Jan2021 . No follow-up attempts are possible. No further information is expected.

Muscle pain; swelling of upper arm; body aches; headache; chills; slight fever; This is a spontaneous report from a contactable consumer reported for himself. A26-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in right arm on 12Jan2021 16:00 at single dose for COVID-19 immunisation. The patient received the vaccine at workplace clinic. Medical history included 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. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced muscle pain and swelling of upper arm, body aches, headache, chills, slight fever on 12Jan2021 23:30. No treatment was received for the events. The events did not result in Emergency Room visit or physician office visit. The outcome of events was recovered. Information on the lot/batch number has been requested.

10 minutes after the second dose, patient developed headache, lightheadedness, dizziness, shortness of breath/anaphylaxis. Transferred to ED, and experienced chest pain, SOB, tightness in throat. Patient was sent to the emergency department. Received 25 mg Benadryl prior to arrival as prophylaxis. Received Combivent in the ED, and symptoms improved. Patient was observed for 4 hours in the ED. Eventually patient was discharged home.

Patient experienced flu like symptoms the morning after receiving his vaccine (1/29). Symptoms improved by 1/31). On 2/1, patient woke up with a rash all over his body that was pruritic. Patient took Benadryl which helped improve his symptoms. Today (2/2), patient woke up with angioedema. He took another Benadryl--symptoms improved. Denies SOB, tongue swelling, itchy throat, or wheezing. Swelling is localized to lips only.

Bilateral painful and enlarged cervical, supra-clavicular, and axillary lymph nodes - Onset: 12 hours post-vaccination Duration: >40 hours; Bilateral painful and enlarged cervical, supra-clavicular, and axillary lymph nodes - Onset: 12 hours post-vaccination Duration: >40 hours; Fever - Onset: 6 hours post-vaccination Duration: >40 hours; Generalized muscle soreness - Onset: 6 hours post-vaccination Duration - 30 hours; Headache - Onset: 6 hours post-vaccination Duration: >40 hours; Tiredness - Onset: 4 hours post-vaccination Duration: >40 hours; Injection site soreness - Onset: 2 hours post-vaccination; Start Date/Time:17Jan2021 03:00 PM; Start Date/Time: 31Dec2020 01:00 PM; This is a spontaneous report from a non-contactable healthcare professional (patient). A 26-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3247), via an unspecified route of administration on left arm on 17Jan2021 15:00 at a single dose for COVID-19 immunization. There were no medical history and concomitant medications. The patient had no known allergies. No other vaccine in four weeks. No other medications in two weeks. No COVID prior vaccination. The patient previously took first dose of BNT162B2 (lot number: EL0142) on 31Dec2020 13:00 on left arm for COVID-19 immunization. On 17Jan2021, 2 hours post-vaccination (17:00) patient had injection site soreness; 4 hours post vaccination patient had tiredness for more than 40 hours; and 6 hours post vaccination (21:00) patient had fever for more than more than 40 hours, generalized muscle soreness for 30 hours, and headache for 40 hours. On 18Jan2021, 12 hours post vaccination (03:00), patient had bilateral painful and enlarged cervical, supra-clavicular, and axillary lymph nodes for more than 40 hours. There was no treatment for the events. Patient was not COVID tested post vaccination. The outcome of the events was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

pt is hospitalized 2/21/21; current LP is pending; pt has fevers, occipital pain, malaise, neck pain, vomiting; elevated ESR & CRP; MRI & Ct Scan are negative. infectious disease physician Dr.'s differential diagnosis is: Meningoencephalitis (LP performed and is pending results) Vaccine

Two days after second shot Patient experienced: tingling/numbness in both hands; A rash to his face,chin and to both arms; Itching with bumps, swollen fingers and toes; Rash and swelling moves around body with elevated joint/bone pain; fevers on/off. 2/13/21- Went to Urgent Care, given Keflex with no change.2/15/21- Urgent Care second visit, Keflex stopped.2/17/21- Clinic, Benadryl & Tylenol PRN and labs done with no change in rash, Covid test negative. 2/18/21- Dermatology Appointment- Doxycycline 100mg BID, Hydroxyzine PRN, Zyrtec OT, Punchbx left ankle. 3/11/21 - No diagnosis made in Hospital or from follow-up visit with Dermatologist. Continue to have occasional area of transient redness and some numbness and tingling in hands.

Symptoms showed up as swollen lymph nodes on left side of neck and head (around ear) with swollen bumps running up the back of the scalp. These large bumps eventually split into a painful rash and scabbed over.

5 minutes after getting shot, started to feel same effects of Tree nut allergy anaphylaxis. Did not need an EpiPen, but still had trouble breathing for the day.

Fatigue, lymph node swelling, night sweats and fever, chest tightness, muscle ache and pains (full body). All symptoms persistent and ongoing, beginning after second dose.

All symptoms are for the second dose. Fever and chill 16-18 hours after the vaccine, which subsided quickly. Swollen lymph nodes at the armpit of the arm injected with the vaccine 24 hours after the vaccine, still ongoing. Severely swollen tonsils, still ongoing.

Swelling underneath my left arm pit which may be a possible blood clot; Swelling underneath my left arm pit which may be a possible blood clot; This is a spontaneous report from a contactable consumer (patient). A 26-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) on the left arm on 08Apr2021 (16:15) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 09Apr2021 (05:45), the patient had swelling underneath my left armpit which may be a possible blood clot. The patient did not receive any treatment for the reported events. The outcome of the events was not recovered. The patient did not have COVID-19 prior to vaccination, and had not been tested post-vaccination. Information on the lot/batch number has been requested.

4/13/21: 26 y.o. male who presents with central nonradiating chest pain and dyspnea for the past 2 mornings. Seen in urgent care and sent here for elevated troponin. EKG nonischemic. No symptoms currently. Repeat troponin slightly elevated. BNP elevated but no clinical evidence of heart failure. CRP elevated, sed rate normal. Respiratory viral panel negative. CTA PE study negative for PE or other acute pathology. Echo normal per cardiology prelim report verbally. Patient hemodynamically normal. Respiratory viral panel including Covid negative. Concern for possible vaccine reaction. Will be reported by pharmacy. Seen by cardiology in the emergency department. Will be admitted overnight for observation given concern for troponin still climbing as well as monitoring for arrhythmia. Patient concerned about being admitted but willing to stay after further conversation.

Initial event was hives that didn't itch appearing on elbows, they continued to spread for about a day. The doctor said to start Zyrtec, pepcid and ibuprofen. Hours later vomiting, diarrhea, and a blackout followed along with a fever of 102. This time ER gave IV fluids, acetaminophen, ketorolac, ondansetron, and sodium chloride .9%. At this time no mention or notice was made of the hives previously looked at. After this Zyrtec, Pepcid and acetaminophen were being taken regularly. Throughout the rest of that day the hives got worse along with pretty severe angioedema. Also, a feeling of swollowing around a lump in my throat. No change through the night into next day (Friday) for the hives,swelling and lump feeling in throat. Went to walk in clinic where I was prescribed prednisone tapered for 16 days. After the first day of steroids not much change. After 2 there was some improvement. As of today one week after receiving the 2nd dose of the vaccine approximately 90% of the hives are gone, only mild swelling and some muscle fatigue and pain left.

Patient received his first Pfizer dose 21 days prior in his left arm. The lymph nodes in his throat were still visibly swollen and palpable. He spoke with a nurse prior to coming who advised him to get second dose. RN assessed patient for any additional symptoms that he may have been experiencing and informed him that he should follow up with his primary doctor.

Felt a little sick the day after. Significant arm pain for 2 days after. Starting 5 days after lymph node under armpit swelled to the size of a nickel (by 4/24/21) and was very painful. Returned to normal around 4/27. At about that same time lymph nodes under jaw began to swell and were painful by 5/1. This seemed to return to normal by 5/6. Since then no other adverse affects.

Swollen neck muscles, enlarged lymph nodes under armpits for about a week and a half (may 1-may 14) lump in neck currently- think it?s a lymph node- swallowing a lot w/lots of saliva , headaches, dizziness, tired a lot, weird flashes over my body, legs feeling warm sometimes then goes, ran a small fever in the beggin. Of may - 99.4, nausea, popping behind ears when I swallow currently, anxious

Uncontrollable body shakes without a fever; Pain in lymph node under left armpit; full body aches; Headache; This is a spontaneous report from a contactable consumer or other non hcp reported for himself. A 26-year-old male patient received second dose bnt162b2 (BNT162B2, Formulation: solution for injection, Batch/Lot Number: EL3247; Expiration date was unknown), via an unspecified route of administration, administered in Arm Left on 10Feb2021 10:15 (at the age of vaccination 26-year-old) as 2nd dose single, for COVID-19 immunization. Medical history included asthma, Heart arrhythmia. Patient previously received first dose bnt162b2 (BNT162B2, Formulation: solution for injection, Batch/Lot Number: EL3247; Expiration date was unknown), via an unspecified route of administration, administered in left arm on 19Jan2021 13:30 (at the age of vaccination 26-year-old) as 1st dose, single for COVID-19 immunization. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Patient had no known allergies. On 11Feb2021 01:00 the patient experienced uncontrollable body shakes without a fever, pain in lymph node under left armpit, full body aches, headache. Patient did not receive any treatment for events. Reporter considered all the events as non-serious. The outcome of event was Not Recovered/Not Resolved. Follow-up attempts completed. No further information expected.

Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Hyperventilation-Severe, Systemic: Seizure-Severe

A 26-year-old male with no past medical history presents to the emergency department (ED) with an acute episode of chest pain. He reports initially mild dull substernal chest pain for a day prior to an episode of acute sharp chest pain that radiates to his left neck and left shoulder accompanied by diaphoresis leading him to present to the ED. He had received the second dose of the Pfizer-BioNTech mRNA COVID-19 vaccine three days prior to presentation and reported myalgia and weakness beginning within 24 hours of vaccination. His blood pressure on arrival was 126/83 mmHg and pulse was 61 bpm. Electrocardiogram (ECG) on admission showed diffuse upsloping 2mm STE, no reciprocal changes, and PR elevation in aVR. Troponin-I on admission was 6.03 ng/ml prior to peaking at 21 ng/ml while initial CRP was 56.8 mg/L. Transthoracic echo (TTE) showed left ventricular ejection fraction (LVEF) of 55-60% with hypokinesis of the basal lateral wall. Cardiac magnetic resonance imaging (CMR) was consistent with myocarditis showing subepicardial late gadolinium enhancement (LGE) in the basal inferior wall, no edema on T2 sequences, and a mildly reduced left ventricular systolic function with an LVEF of 51%. He was started on colchicine, low dose beta blocker and losartan and improved symptomatically along with resolution of the EKG findings prior to being discharged with plan for close outpatient follow-up and repeat imaging. In addition, a respiratory viral PCR panel was obtained which was positive for Rhinovirus/Enterovirus on nasal swab. Although it is possible that his presentation was secondary to enteroviral myocarditis, the temporal relationship to the second dose of Pfizer-BioNTech mRNA COVID-19 vaccine suggests the possibility of myocarditis secondary to immunologic response to COVID-19 vaccine itself.

Patient received first injection left deltoid in April; 2 weeks later swelling and pain with reduced range of motion to the left shoulder. Received second injection right deltoid in May; 2 weeks later swelling and pain with reduced range of motion to the right shoulder and worsening persistent symptoms to left shoulder. Symptoms are persistent. Not related to Sickle Cell Crisis; has been seen by specialists.

swelling of lymph nodes; loss of hearing in right ear; right ear began to feel full with pressure/pain; right ear began to feel full with pressure/pain; dizziness; vertigo; ringing in right ear (tinnitus); This is a spontaneous report from a contactable consumer (patient). A 26-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 20Apr2021 (Lot Number: EW0171) (at the age of 26-year-old) as single dose for COVID-19 immunisation. Medical history included non-alcoholic fatty liver disease, allergies, asthma, autism, sensory integration disorder, appendectomy, pilonidal cyst removal, all from an unknown date and unknown if ongoing. Prior to vaccination the patient was not diagnosed with COVID-19 and since the vaccination the patient has not been tested for COVID-19. The patient's concomitant medications were not reported. The patient previously took penicilline, tetracycline, amoxillin [amoxicillin sodium] and hydrocodone. The patient experienced dizziness/vertigo within a couple of hours of first vaccine on 20Apr2021. Developed ringing in right ear (tinnitus) on same day. By 21Apr2021, right ear began to feel full with pressure/pain. All symptoms continued with swelling of lymph nodes and loss of hearing in right ear by 22Apr2021. The events were assessed as serious, disabling. The patient saw otolaryngologist (ENT) for hearing test and evaluation on 27Apr2021, hearing test showed substantial loss of hearing in right ear. Steroids were prescribed and taken. The patient underwent lab test and procedures which included magnetic resonance imaging (MRI): unknown results on an unspecified date. Dizziness/vertigo either resolved on 29Apr2021. The patient outcome of the other events was not recovered. No follow-up attempts are needed. No further information is expected.

Patient presented to the ED with swollen uvula, swollen face, hives on neck and waist, and severe headache approximately two days after the first dose in the COVID 19 vaccine series. The patient was treated with diphenhydramine, methylprednisolone, epinephrine, and famotidine.

Cold sores, hives, bumps, rashes, severe itching over arms, legs, chest, and back of neck. Numbness and tingling in cranial nerves. Back of neck hot, pins and needles. Severe head fog, fatigue.

Sore / achy; Feverish; Chills; red and tender swollen injection site; red and tender swollen injection site; red and tender swollen injection site; Lightheaded; swollen and tender armpit glands,; Elevated heart rate; swollen and tender armpit glands; This is a spontaneous report from a contactable consumer, the patient. A 26-year-old male patient received his first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: er8735) via an unspecified route of administration on 26Apr2021(at the age of 26 years old) as a single dose, for COVID-19 immunisation. Medical history included COVID-19 on an unknown date. Concomitant medications were not reported. The patient reported that his past drug history included dairy (unspecified). Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. The patient experienced sore / achy, feverish, chills, red and tender swollen injection site, lightheaded, swollen and tender armpit glands and elevated heart rate on 26Apr2021. The patient did not receive any treatment for the events. The clinical outcome of the events sore / achy, feverish, chills, red and tender swollen injection site, lightheaded, swollen and tender armpit glands, elevated heart rate were resolving at the time of this report. No follow-up attempts are needed. No further information is expected. Amendment: This follow-up report is being submitted to amend previously reported information: Patient email address added, medical history added (known allergies: dairy), treatment received was ticked as No and updated narrative.

Lymphadenopathy on same side of shot; This is a spontaneous report from a contactable consumer, the patient. A 26-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730), via an unspecified route of administration in the left arm on 24Mar2021 at 17:15 (at the age of 26-years-old), as a single dose for COVID-19 immunisation. Medical history included asthma. The patient did not have any allergies to medications, food, or other products. Concomitant medications received within 2 weeks of vaccination was reported as not applicable (N/A). The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6205), via an unspecified route of administration in the left arm on 02Mar2021 at 09:15 (at the age of 26-years-old), as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 26Mar2021, the patient experienced lymphadenopathy on the same side of the vaccination. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the event. The clinical outcome of lymphadenopathy was not recovered. No follow-up attempts are needed. No further information is expected.

Swollen lymph nodes; This is a spontaneous report from a contactable consumer, the patient. A 26-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE;Lot Number: EP7534) via an unspecified route of administration in the arm right on 01Apr2021 at 15:15 (at the age of 26-years-old) as a single dose for COVID-19 immunisation. Medical history included hypertension. Concomitant medications included lisinopril (MANUFACTURER UNKNOWN) and amlodipine (MANUFACTURER UNKNOWN). The patient previously took flu shot and experienced minor outbreak of hives on his hands in 2016-17. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 03Apr2021 at 12:00, after 2685 minutes of the vaccination, the patient experienced swollen lymph nodes. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the event. The clinical outcome of the event swollen lymph nodes was not resolved at the time of this report. No follow-up attempts are needed. No further information is expected.

I would like to start out by saying that I am well aware that this vaccine is known to cause side effects and that the benefits of the vaccine far outweigh any side effects induced by it. The reason I am writing this is to provide information that you all can keep in mind as you provide guidance on your recommendations for the timing of when the vaccine should be administered to those who have already tested positive for COVID. I tested positive for COVID-19 11 days prior to getting vaccinated. My symptoms from the virus began on 12/21/20, lasted until 12/26/20 and included: mild headache, fever of 100.3, moderate muscle fatigue, lymphadenopathy, and sinus congestion. I received the Pfizer vaccine on 1/3/21 at 11am and by 2am on 1/4/21 I was experiencing a temperature of 102.5, severe headache, severe muscle fatigue, and painful right axillary lymphadenopathy. Although they had almost completely resolved by 11am on 1/4/20, I would describe these side effects to the vaccine as significantly worse than the symptoms of the virus itself. As someone who has a stronger medical background than the general public (I am a 4th year dental student in a patient-facing role and was encouraged by my school to receive the vaccine despite already testing positive), I understood the likelihood of developing side effects to the vaccine and I am still planning on receiving my second dose in three weeks despite already showing clear signs of a strong immune response to the proteins created by the vaccine. The reason why I am writing this is because there was no guidance on recommending that I wait longer than 10 days between testing positive and receiving the vaccine and I am worried that if the general public is allowed to receive the vaccine at this same time interval, there will be a significant number of people who will have similar side effects (worse than those induced by the virus itself) and they will not only refuse a second dose, but could also vocally discourage many people from trusting the vaccine?s safety and benefit. I obviously don?t know what minimum timeframe should be recommended, but from my individual experience, 11 days was not sufficient. I will be happy to follow up if you would like to know how the symptoms fare after my second dose.

I started to feel achy all over my body. I was having chills as well. I was still able to work throughout the day 1/7/21. I've had a pain in my right arm pit that hasn't gone away. I feel a lump that is moveable and about 1 cm in diameter that is painful constantly and when I message it in my right arm pit. I feel fine otherwise 1/8/21 morning and am still going to work.

Multiple left supraclavicular lymph node enlargement. Tender to touch. Started on 01/12/2021, has increased slightly. On 01/18/2021, felt an additional lymph node.

Fever on and off for 1.5 days starting ~14 hours after initial injection, and swollen cervical lymph nodes starting ~72 hours after initial injection (ongoing).

About 12 hours post-injection I began noticing hot/cold flashes and running a fever. Between 10:30pm and noon on January 22nd, 2021 I've experienced continued hot/cold flashes, fever, nausea, muscle aches, injection site pain, congestion, headache, and minor swelling and pain of the lymph nodes in my left axilla area. So far the fever seems to have broken with Tylenol, water, and rest. Still experiencing significant muscle aches, left axilla pain, headaches, congestion, and general fatigue.

Headache, Muscle and joint pain, Fatigue , Sore throat, Cough, Shortness of breath , Abdominal pain , Facial swelling , Nasal congestion , Diarrhea , Nausea. Benadryl IM, Prednisone tablet, Ventolin inhaler.

Pfizer-BioNTech COVID-19 Vaccine EUA Headache, chills, sore arm, low grade fever for 2 days following administration starting 12 hours after vaccine. 2.5 days later, I got upper lip angioedema that resolved within 1 day with Benadryl and Zyrtec

Patient presented to Urgent Care 3 days after his second dose of Pfizer COVID-19 vaccination.. He reported a 10 day issue of a left axilla mass (12 cm) with new onset of tenderness.

Occipital neuralgia; anaphylaxis; feeling like passing out on and off for the next 2-3 hours; he felt lightheaded; little short of breath; fatigue; he had a lot of posterior lymph pain in the back of his head, for 2 weeks on and off; heaviness at the back of his head left sid; chest tightness; he developed a sensation like he was going to lose control of his mind; This is a spontaneous report from a contactable Other Health Professional, the patient. A 27-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL1283), via an unspecified route of administration on 08Jan2021 at 13:30 (at the age of 27-years-old) as a single dose in the left arm for COVID-19 vaccination. Medical history included asthma exacerbation, GERD, childhood anemia, a retinal tear in the right eye all from unspecified dates and unknown if ongoing. The patient also reported medical history three episodes (June 2019, August 2019 and October2019) of anaphylaxis due to "Exercise Induced Anaphylaxis." Historical vaccinations included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EH9899) on 21Dec2020 at 13:30 after which he experienced pain at the vaccination site which lasted twenty-four hours. The patient's past product use included adrenaline (EPIPEN), an unspecified corticosteroid and an unspecified antihistamine for past allergic reactions. The vaccine was administered in a hospital. Prior to the vaccination, the patient had not been diagnosed with COVID-19. Concomitant medications included ciclosportin (RESTASIS), azelastine (AZELASTINE), mometasone furoate (FLONASE), cetirizine hydrochloride (ZYRTEC) and omeprazole (PROTONIX) all for unknown indications from unknown dates and unknown if ongoing. Within four weeks prior to the vaccination the patient had received unspecified "allergy shots" He received "two shots" (one in each deltoid) on 15Dec2021 and "two shots" (one in each deltoid) on 05Jan2021. The patient reported that fifteen to thirty seconds after the second dose of the COVID-19 vaccination he felt lightheaded and a little short of breath. This lasted about eight minutes and then subsided. Approximately thirty to forty minutes (about 30 minutes after he left the facility) later the symptoms returned. He felt short of breath and he thought he was going to pass out. The symptoms included fatigue, shortness of breath lightheaded and feeling like passing out on and off for the next two to three hours. He stated he has completely recovered. He continued to say that he was feeling fine for three days then he began having bilateral cervical lymph pain greater on the left than right, a lot of posterior lymph pain in the back of his head (for two weeks on and off). These symptoms also resolved on their own. He also experienced ("a couple of days later") a sensation where he thought he was going to lose control of his muscles and lose consciousness. He also developed a sense that the was going to lose control of his mind with heaviness at the back of his head, left side. He went to the Emergency Room (date not provided) and they provided Valium. He also reports an Emergency Room visit on 13Jan2021 during which he underwent a CT scan of the head which was normal and a neuro consult suggesting occipital neuralgia and he was put on muscle relaxers. He also stated that experienced shortness of breath and chest tightness after his allergy shots on 26Jan2021 and he specified that he had never before had these reactions to his allergy shots. After that he had yet another possible allergic reaction after eating pizza on 30Jan which included throat swelling as well. He further stated that on 04Feb he had anaphylaxis vs asthma exacerbation. On the following day he developed a heaviness to his left occipital head with that same feeling of wanting to lose control of his muscles. He never had that before. He started Prilosec about one and one half weeks prior to the reporting date. In follow up the Other HCP reporter/patient answered "Yes" to the following questions (DCA) about symptoms experienced: Bilateral wheeze/bronchospasm, upper airway swelling, increased use of accessory respiratory muscles, dry cough, difficulty breathing (without wheeze or stridor, sensation of throat closure, tachycardia, nausea. These were reported without dates and without context with regard to the events reported initially. These were also reported as not requiring treatment and having recovered on unspecified dates. Lab data included three SARS COV 2 nasal swab tests (14Jan2021, 03Feb2021 and 11Feb2021) all of which were negative. Unspecified treatment was reported for the events anaphylactic reaction and mental impairment. The clinical outcomes of the events Anaphylaxis, loss of consciousness, dizziness, dyspnea, fatigue and lymph node pain were reported as recovered on an unspecified date in 2021. The clinical outcome of mental impairment, heaviness of head, chest tightness and occipital neuralgia were reported as unknown.

Woke up this morning and my armpit on the side that I received the shot was slightly swollen and tender.

The female medical employee, who was administering the vaccination. The Pfizer Vaccination. Opened a shot syringe. That had an empty vile. The syringe did not have the dosage of vaccine. The female medical employee, documented on my immunization card the sticker Lot number #EN6204, but the vaccine Lot Number (the syringe received) was not the Lot Number indicated on the immunization card. Why? The female medical employee, called over the military personnel whom was being the security for the vaccination site. The female military personnel was holding an open unit syringe vile dosage of the vaccine. The female medical employee showed the empty syringe vaccine to the military personnel. She said, "The dosage fell out." The female medical employee, took the open package, of the syringe vile, that contained a measured dose of the vaccine. Which is not considered the full dosage, or considered a safe dosage of the vaccine, because the package was opened. Not in front of the patient. And. Was open, when the military personnel, who was holding this vile, was walking, with the open package, around without proper medical gear. The medical employee. Quickly took out the syringe. Didn't explain which and what that syringe was, and just injected the dosage into my arm. I know, that practice was malpractice. I know I experienced malpractice. And. It's obvious the Government is going to do anything about it. This is not a petty situation. I don't know where that needle from. What has been introduced to that open syringe package. I did experience very bad side affects: headaches, muscle pains, tiredness, fatigue, weakness, low strength, dizziness, partial blindness, overwhelming stress, back pain, joint pain, spinal pain, chills, fever like symptoms, nausea, spontaneous pain, soreness in the arm, swelling throughout my body, difficulty breathing, short breaths.

I've been experiencing mild, but consistent adverse side effects to the vaccine. This vaccine. Is completely Terroristic. This vaccine is a biological warfare. I've been very active in obtaining vaccinations. Flu shots, up to date with tetanus, and obtaining a second Immunization for chicken pox because I actually received the chicken, but had no vaccination. And. I need the vaccination record for school. So I had to get the chicken pox vaccine. I've been having mild, but very uncomfortable and consistent headaches. My sinuses all over my face are so filled. My eyes are watery, turn red, and at time so painful that it's difficult to open them. I have muscle weakness. I'm always so thirty all the time. My urine smells like uric acid. Has a rancid toxic smell to it. And. My urine is clear. But smells. My skin feels silky. And. the perspiration from my body, smells like formaldehyde. Smells clean, but smells like toxic formaldehyde and dead sticky body residue. The most uncomfortable is the partial blindness. Headaches. Muscle aches. Joint aches. Neck pains. Eye pains. The consistent thirst. I can't go to the doctor because I don't have insure. But. Most importantly. I don't have employment, because of the Government's illegal employment system that accounts for me. I've been unemployed for 6 years. And. Have a private college degree from one of the top Universities in the USA. Also. I've been very active in producing sputum. Flem. My neck is swollen. And parts of my body are swollen. Not severely. But you can see there is minor swelling. All the symptoms I'm disclosing in this report, are minor. But. When collectively experienced. Is unbarable. Extremely Uncomfortable. And. You're expecting me to get another dosage of this experience. Being. 2 months incapacitated. This is even illegally distributed. What the hell. In God's name. Are you people in there doing. And. Why are you people in the Government even able to get away with this.

Swollen lymph node in neck since March 24th 2021. I have recently been experiencing muscle fatigue/dull aching in my left arm, left side of neck, left shoulder, and upper left back.

Supraclavicular lymphadenopathy following COVID-19 vaccination. Left supraclavicular lymph node is swollen and tender to the touch.

- Swollen lymph node on collarbone; started ~ 48 hours after second dose; resolved over course of two weeks. - Body Aches, Chills; started 12 hours after second dose; resolved about ~ 48 hours later.

When I woke up on Sunday, April 11th, 2021 at around 9am, I have felt like my muscles have been ripped apart, I was sweating, I had labored breathing, and I could not get up for the day. I slept all day, feeling like I had the flu, and was sleeping until 7pm that day. I called out of work when I woke up because I knew on Monday I would not be able to make it, as I felt like I was very tired, lethargic, and sore. This feeling was throughout every inch of my body. I also went to take a shower that day and I had a hard time breathing in the shower, to the point where I had to sit on the edge of the tub, just to make sure I would not pass out from lack of oxygen. This was the scariest sickness I have ever had in my entire life. I literally thought I was going to die. Monday came around and I felt even worse, my muscles were sore, I felt extremely tired, I could not do anything, and I was in bed all day. Today is Tuesday, and I have felt a little bit better, but I have missed two days of work because of the effects this vaccine has had on my body. I made a virtual appointment with a doctor on the app on phone and met with Doctor who basically told me that the only thing I could do for myself is take Ibuprofen every 8 hours for the pain and swelling that might occur and drink plenty of gatorade. It is Tuesday, April 13th, 2021 at 11:29pm at night and I still feel the same as Monday, very weak, tired, and sore all over my body. I have never had this with a vaccine before, until I got the COVID-19 one. I have taken the Flu Vaccine, Hep A, Tantnius, Chicken Pox and never felt like I was so tired I could not get out of bed from these vaccines.

After receiving second dose of injection Pfizer vaccine. I begin to experience side effect including headache, redness, swelling, and tiredness. 1 days later, the condition of those got better but the redness does not go away. My under arm begin to form small red area, very similar to chicken pox. these red area return daily and appear more frequence.

On day 3 following, 2nd dose of Pfizer vaccine, he had right sided calf pain. Initially thought to be recurence of strain injury, although no history of trauma or obvious trigger. Pain conitnued to worsen and had different characteristics than original strain symptoms. Continued to worsen to point wher eunable to weight bear and swollen, hot and red. Saw orthopedist who refered to vascular surgeon, and on day 13 was officially diagnosed with large DVT extending form tibeal & peroneal, popliteal up to the femoral veins. Has no known clotting defects. Currently under evaluation with hematologist who recommended anticoagulants for remainder of his life.

Patient with known alcoholism, found down and out covered in blood for an unknown period of time. Brought to Healthcare Facility by ambulance for treatment, and planned to transfer. Suspected GI bleed; when flight crew arrived, decided to intubate. Failed first attempt, and patient when into cardiac arrest. Was revived with CPR and 2 doses of epinephrine. Pt also received TXA and 1 unit PRBC, and fluids. Successful second attempt, though BPs remained labile. Pt transferred to ICU and was notified that additional evaluation found bleed had actually occurred proximal GI tract (oral mucosal bleed, not esophageal). Pt also diagnosed prior to transfer with multilobar pneumonitis, ascites secondary to alcohol cirrhosis, hematemesis/meme positive stool, leukocytosis and pancreatitis. Was notified by ICU less than 24 hours later that pt was on vent and stable.

Woke up the morning after receiving vaccine and had swollen right shoulder/armpit with some edema in armpit. Tender to touch but not painful

He received the 1st dose of the Pfizer COVID vaccine on 4/22/21 and within 5 minutes, developed coughing, sneezing, and rhinorrhea. Within 2-3 hours, symptoms progressed into pt having swollen and red cheeks and red eyes. Denies any sob, tongue or lip swelling, hives, abd pain, dizziness. His BP was his normal, O2 was normal and he was sent home. He did not take any Benadryl or use epinephrine. That night he had subjective fever and night sweats. The symptoms lasted for 2 days and pt used Tylenol for symptomatic relief. Sx resolved by the 3rd day

Hives appeared and covered the whole body overnight 3 days after the vaccine but no anaphylaxis. Took Benadryl in the morning and the hives slowly went away during the course of the day. The following night, woke up at 4am covered head-to-toe in hives, swollen face, lips, difficulty swallowing. Called 911 and was treated with an epinephrine pen, symptoms slowly subsided over the next few hours after being monitored at the ER. No previous experience with allergic reactions or anaphylaxis.

fainted; lost consciousness for a couple of seconds; burning pain that felt like needles on his shoulder, left arm and a little on the right side/extremely, burning pains across his back/He had burning pain on his shoulders, very sensitive, felt like a 3rd degree burn; felt like he could not stand and had to go to the floor, struggled to get up; arms were numb; thought he was having a heart attack; left arm weak; skin is hypertensive: back of neck feels like a third degree burn: if he moves the hair on his arms it hurts; left side of face is swollen; left side of face is swollen was reported as worsened.; skin is hypertensive: back of neck feels like a third degree burn: if he moves the hair on his arms it hurts; skin is hypertensive: back of neck feels like a third degree burn: if he moves the hair on his arms it hurts; left arm pain; This is a spontaneous report from contactable consumers (patient reported for himself, patient's mother). A 27-years-old male patient received bnt162b2 (BNT162B2; PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular, administered in Arm Right on 01May2021 12:00 noon (Batch/Lot Number: EW0170; Expiration Date: 31Aug2021) as 1ST DOSE, 0.3 ML SINGLE for covid-19 immunization, at the age at vaccination of 27 years old. The patient's medical history and concomitant medications were not reported. The patient experienced thought he was having a heart attack(medically significant) on 03May2021 01:00 with outcome of unknown, skin is hypertensive: back of neck feels like a third degree burn: if he moves the hair on his arms it hurts (medically significant) on 03May2021 with outcome of not recovered, fainted (medically significant) on an unspecified date with outcome of unknown, lost consciousness for a couple of seconds (medically significant) on 03May2021 01:00 with outcome of recovered with sequelae on 03May2021, burning pain that felt like needles on his shoulder, left arm and a little on the right side/extremely, burning pains across his back/he had burning pain on his shoulders, very sensitive, felt like a 3rd degree burn (non-serious) on 03May2021 01:00 with outcome of unknown, felt like he could not stand and had to go to the floor, struggled to get up (non-serious) on 03May2021 01:00 with outcome of recovered with sequelae on 03May2021, arms were numb (non-serious) on 03May2021 01:00 with outcome of recovering, left arm pain (non-serious) on 03May2021 with outcome of not recovered, left arm weak (non-serious) on 03May2021 01:00 with outcome of unknown, skin is hypertensive: back of neck feels like a third degree burn: if he moves the hair on his arms it hurts (non-serious) on 03May2021 01:00 with outcome of not recovered, skin is hypertensive: back of neck feels like a third degree burn: if he moves the hair on his arms it hurts (non-serious) on 03May2021 with outcome of not recovered, left side of face is swollen (non-serious) on 03May2021 01:00 with outcome of not recovered , left side of face is swollen was reported as worsened (non-serious) on 03May2021 with outcome of not recovered. The patient underwent lab tests which included computerised tomogram (brain CT): no results, electrocardiogram (EKG): no results, both on unknown date. Reported patient was in pain and his mom and dad didn't know what to do. He had sharp pains. No bruises. He remember lowering myself to fall. He didn't fall. It was a strange thing. When he went to the ER they didn't fine anything. He was still in the same amount of pain. Caller stated her son took the vaccine on Saturday. Thirty six hours later around 1:00am he started getting extremely, burning pains across his back.The patient stated he was coming out of the bathroom and felt like he couldn't stand and he had to go to the floor. He lost consciousness for a couple of seconds. Both arms were numb. He struggled to get up. He sat on the couch and then went upstairs after being in the basement. He had a burning pain that felt like needles on his shoulder, left arm and a little on right side. His skin was sensitive. The back of his neck feels like he has a third degree burn. This morning he went to the hospital. Initially said he fainted but clarified that he was speaking about losing consciousness. He had left arm pain. He thought he was having a hard attack. While at the emergency room today he had labs, a brain CT scan and an EKG. He does not have results to provide. Caller added that his skin was hypersensitive. It was like if he moves the hair on his arm it hurts. His parents noticed he has swelling on the left side of his face. The events require a visit to Emergency Room. No Prior Vaccinations (within 4 weeks). Information on Lot/Batch number was available. Additional information has been requested.

Client sts that he received his 2nd covid vaccine of Pfizer at the Health Department. He sts that he started having onset of severe headache/pressure in head, painful bilateral eye movement and noticed that he has a "swollen lymph node" on the left upper clavicle/neck area. Client sts that this swollen area is palpable, but not painful to touch. He denies any difficulty in breathing, swelling to mouth. sts that his s/s were more severe on 5/19 and 5/20, and seemed to feel slightly better as of today, 5/21.

Moderate aches experienced on the day following vaccination (5/23) beginning in the morning. Two doses of ibuprofen taken in the morning and afternoon. Mild pain experienced in left front armpit, nearly on the left pectoral, on the night following vaccination. On the following morning (5/24), moderate swelling was noticed in the left armpit, extending from underneath the armpit down to the upper lat muscles and up along the left pectoral nearly to the nipple up to just below the left collarbone. Mild pain experienced in the left front armpit as well as on the lymph node under the armpit. No inhibition of arm motion or pain when using arm, but some feeling of discomfort and pressure. Tele-med help was sought which did not recommend any course of action. By the afternoon, moderate swelling was noticed on the left arm, on the bicep and tricep down to the elbow. Ibuprofen was taken at ~3pm with no effect. Medical advice was sought at 7pm and it was recommended to head to urgent care, but all providers in the area were closed. By this morning (5/25), the swelling has reduced significantly and localized to the left front armpit. Mild pain remains, now more localized to the lymph node under the left armpit.

After first Pfizer dose, I was just feeling really tired. After the second dose, around that afternoon/evening I started feeling my mouth feeling weird. The next day I saw blisters filled with yellow/whiteish puss in my tongue. I went to the ER later i felt a lump under left shoulder while showering. On 28 MAY 3 AM I suddenly felt my face feeling numb and tingly along with my legs. Mind you I have been in the field emplacing howizters for the past few days in a field exercise. I also jammed my finger on an 80 lb metal bar on 26 MAY and got my finger poked with a hot device that also drained the blood after getting an xray. I called medical ER at 242 and spoke to Dr.(?) Doctor did not give me his name spelling after I asked for the spelling and he told me that I could always come in to the ER. I told him whether the finger pricking and blooding draining could cause the left facial numbness and legs tingleness. He said no so i am now assuming it is an adverse side effect. I am a smart guy have bachelors in journalism but right now I cannot concentrate and filling out htis form hastily just i case the effects get worse and I have to go to hospital er. Talking to the Dr. (?) was harder than normal and he asked if my breathing was normal, I said i am breathing heavily, which I did not have much control over. He said breathe normally and I will be better from the tingliness. I can write well I am a journalism major but this is hard to write for me . I am also feeling chills and I am also not feeling well. I was able to get this link from my local online meeting and I am glad I can contribute to the research and science in general. I wish the doctor had tested me for possible problems when I had an adverse effect from the first vaccine but the doctor told me to come back if the "viral infection" gets worse after I breathe normal. I did take a PT test and my 2 mile run time increased and it was much harder to run than the 2 mile run. Time went up by at least 3 minutes.

Swollen lips; Swollen tongue; Swollen face; Itchy throat; Lightheaded; weak; feeling Sore on right arm; This is a spontaneous report from a contactable consumer, the patient. A 27-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot/Batch no: EN 6204) via an unspecified route of administration in right arm on 12Mar2021 at 08:45 AM (at the age of 27-years) as a single dose for COVID-19 immunization. Medical history included allergy to sulfa drugs. Prior to vaccination, the patient was not diagnosed with COVID-19. Since vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to vaccination. On 12Mar2021, post the vaccination, the patient felt soreness on the right arm. On 13Mar2021 at 12.00 PM, he started to become very weak, and light headed. On 14Mar2021, he woke up and his entire face was swollen including his tongue and his throat was itchy and on 17Mar2021, his lips and tongue were still swollen. Therapeutic measures included treatment with methylprednisolone acetate (DEPO-MEDROL) 40 mg/ml injection. The clinical outcome of the events vaccination site pain, weakness, light headedness, swollen face, swollen tongue, swollen lips, and itchy throat was reported as not resolved. No follow-up attempts are needed. No further information is expected.

he noticed swelling on the upper L side of his body "underneath arm pit, by ribs"; he noticed pain on the L side of his body; This is a spontaneous report from a contactable consumer (patient) via Medical information team. A 27-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration, administered in left arm on 04Jun2021 at 14:00 (at the age of 27-years-old) as single dose for covid-19 immunisation. The patient did not receive additional vaccines on the same date of the Pfizer Suspect. The patient had no relevant medical history. The patient family medical history relevant to events was reported as her mother has high blood pressure. The patient did not receive any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. The patient did not receive any concomitant medications. The patient previously received first dose of BNT162B2 via an unspecified route of administration, administered in left arm on 14May2021 (at the age of 27-years-old) as single dose for covid-19 immunisation. On 05Jun2021, the patient experienced pain on the upper left side of his body and resolved the following day. On 08Jun2021, he noticed swelling on the upper left side of his body underneath arm pit, by ribs; on the left side of his body that has continued. After he woke today, he took pictures, and he saw the difference. He noticed the swelling after he got out of the shower and he felt it throughout the day. He is chubby but the other side of his body was not the same. It was like he had a roll with sweat underneath it. He was calling to see if this is a serious concern, and he will go to the doctor after work if he needs to. The outcome of event pain was resolved on 06Jun2021 and for another event it was not resolved. Information on the batch/lot number has been requested.

Muscle aches, followed by swollen lymph nodes noted in armpit of arm injected with the vaccine. Noted 2 swollen lymph nodes. Low grade fever prior to going to bed. By the morning symptoms had resolved other than swollen lymph node which remained swollen over next few days.

On the day of the vaccine, 1/7 no reaction. The typical slight sore arm on injection site but nothing odd. On the morning of 1/8 I woke up with noted chills and headache. I checked my temp and noticed 100.4* oral temp. I also had back pain, muscle pain, headaches, continued fever (improved with motrin) and chills. My left arm from my shoulder to my wrist was with noted pain/aches, improved with motrin. On the morning of 1/9 I felt much better, did not take any motrin/tylenol and without any fever/chills. Noted improvement of muscle aches in general and arm felt the same as 1/7 (much better!). Noted lymph swelling of my axillary lymph nodes with aching pain. This has not gone away at current but improved with x1 dose of motrin.

Systemic: Anaphylaxis-Severe, Systemic: Rash (other than injection site)-Medium, Systemic: Minor Rash/Itching/Shakiness on left side, followed by trouble breathing; symptoms lasted 1 day

According to patient, he received the COVID vaccine on 1/18 and endorsed typical vaccine symptoms (myalgias, fatigue, lymphedema on right axillary, sweats and chills). He was taking ibuprofen for prophylactic symptom relief and was able to attend work the following day. The patient stated to still endorses symptoms of the vaccine days after but did not seek medical attention because he thought the symptoms would resolve. The morning of 1/21, patient sustained constant, nonradiating chest pain located along the sternal that was moderate to severe in nature and exacerbated with deep inspiration that lasted 2 hours. Lying on the side provided minimal relief but the pain was still moderate. Nausea also accompanied the pain but the patient denied any vomiting. Patient decided to go to the ED for work-up. Patient had two further episodes of chest pain and EKG revealed diffuse ST elevations. Troponin level peaked at 3.02. He was diagnosed with myopericarditis and started on colchicine, with improvement of chest pain.

Tenderness at injection site lasting ~36 hours Noted weakness and loss in dexterity in hand Feeling of swelling in hand Pins and needles sensation in full arm and extending through fingers

Left forearm swollen the night of the shot. Next day, Sunday, right hand swollen. Monday morning, left eye swollen shut. Wednesday morning, right eye swollen

1st shot of Pfizer-BioNTech: 12/29/2020, left shoulder: marginal shoulder pain from 12/29 to 12/31, no further swellings (ek9231) 2nd shot of Pfizer-BioNTech: 01/22/2020, also left shoulder (el3247): less shoulder pain throughout; feeling that it "spreads" from injection side to left side of the neck in the following hour; on the 01/24 in the morning, palpable swollen lymph node with accompanying calor and dolor right on top of the left clavicular bone; 01/25 swelling reduced, calor and dolor mostly gone but lymph node still palpable No additional drugs taken and on a scale of 0 to 10 maybe a 2/10 causing discomfort

Hives from neck down to elbow on left side. Wet cough, chest pain over sternum and on left side llq on coughing. Fatigue, arm pain, localized swelling/inflammation.

Pfizer-BioNTech COVID-19 Vaccine swollen lymph nodes around collar bone and neck. First started noticing them that night. There were two swollen. 2 days later, 3 new lymph nodes swollen. It has been about 2 weeks and lymph nodes still swollen

pt experiencing rash to trunk, neck, back, swelling to lower lip and left toes. pt received 50 mg po benadryl, 50 mg iv benadryl, epi 0.3 mg IM left thigh, iv, ns 1 liter IV

Tingling sensation throughout body 1 hour after vaccination, followed by numbness. 1 hour and 20 minutes after the vaccination my face started swelling.

Swelling; Numbness; Tingling; received the most recent COVID-19 vaccine subcutaneously; This is a spontaneous report from a contactable consumer (patient). A 28-year-old male patient received bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE), dose 1 subcutaneously administered in left arm on 29Mar2021 12:45 (Lot Number: 1239921-00) as a single dose for covid-19 immunisation. Medical history included type 1 diabetes and allergic to tempeh (it's a food). The patient was not diagnosed with COVID-19 prior vaccination. Concomitant medication included amoxicillin (AMOXICILLIN). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received the most recent COVID-19 vaccine subcutaneously in a pharmacy or drug store. On 29Mar2021 14:00, the experienced swelling, numbness and tingling which was considered serious since the patient was hospitalized (unspecified date in 2021) for 1 day (unspecified date in 2021). The adverse event required doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care and hospitalization. The events required treatment which included Benadryl. The patient has not been tested for COVID-19 since vaccination. The outcome of the events was recovered on an unspecified date in 2021 with sequel.

Headache started next morning. Very severe headache. The next day fever and chills developed along with severe fatigue and swelling in left arm (vaccination site)

Blurred vision; Face and skin are red; Lips tingling; feeling slightly itchy at the injection site after the vaccine/Itching all over his head, scalp, arms and hands, everything; Hives; Tongue and lip swelling/Tongue was starting to swell; Tongue and lip swelling; Shortness of breath; Tachycardia; Anaphylactic shock/anaphylactic reaction; Still has a rash and is itchy/break out rash and get itchy again; Not really wanting to eat dinner; I got home my arm had swollen/Whole arm and hand were swollen; I started feeling slightly itchy at the injection site after the vaccine; Nausea; This is a spontaneous report received from a contactable consumers and other Health Professional. This is a report combining information from duplicate reports 2021372891 and 2021368246. The current and all subsequent information will be reported under manufacturer report number 2021368246. A 28-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection; lot number : EP7533), dose 1 intramuscular, administered in Arm Left on 02Apr2021 11:30 (Batch/Lot Number: EP7533) as SINGLE DOSE for covid-19 immunisation. Medical history included Sleep Apnea ongoing; idiopathic hypersomnia ongoing; High blood pressure (They want to treat her husband for high blood pressure but they don't want to do that until after these reactions. She clarifies he was having issues with high blood pressure prior to getting the vaccine); Little overweight. Concomitant medication included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) from 2020 and ongoing 20 mg, 1x/day; modafinil from 2019 ongoing 200 mg, 1x/day for Idiopathic hyposomnia for Sleep apnea. patient got the first dose of the vaccine on Friday and within 30 minutes, went into anaphylactic shock and was taken to the local emergency room after being administered Benadryl and an EpiPen without any kind of changes. He was discharged and then on Sunday night, he went into anaphylactic shock again and was taken back to the ER after once again being administered Benadryl and an EpiPen. Now, he was kind of starting to break out in a rash again. This has thrown them for a loop because most of the time they had heard that more severe reactions come with the second dose. She confirms this was her husband first dose. Her husband had sat at Pharmacy for the required 15 minutes and he was feeling a little itchy around the vaccine site. It was just around the site, so they left. In the 10 minutes to get home, he started itching all over his head, scalp, arms and hands, everything (02Apr2021). they looked at his site and his entire arm was starting to swell and there was a rash that had gone all the way down his arm. her husband whole arm and hand were swollen and his tongue was starting to swell. He was administered liquid Benadryl and the Epi shot, He was brought to the emergency room at the hospital. He went home after going to the ER. Her husband had another anaphylactic reaction last night. He hasn't had any new foods or exposure to anything. states that they did say it was possible to have a relapse but that it was rare. He had presented slightly differently but kind of similar. It started with him feeling nauseated and not really wanting to eat dinner. He went upstairs to shower and he started to get itchy again. So, she administered 50ml of liquid Benadryl to just get it into his system and then about 10 minutes later, it was not really having any effect and his tongue and stuff started tingling. She looked at his tongue and his tongue was starting to swell again. So, that's when she administered the EpiPen and 911 was called. Her husband was brought to the Emergency room again and was discharged a few hours later. They didn't keep him overnight for observation or anything. states he is still experiencing blurred vision, red skin, and chest is still red a little bit at the top, and his face is red. His lips are started to tingle but was not interfering with his breathing yet, shortness of breath, tachycardia 02Apr2021. Caller states that about 1 hour ago, patient took one tablet of Benadryl and was given 20ml liquid Benadryl 15 minutes ago. Tests: X-ray was clear (Negative), blood work came back normal. She just feels like its getting to the point where everything is just being prolonged. When they went to the ER, he was been on Benadryl, EpiPens, they provided him steroids, Oxygen, Prednisone, Pepcid to try and prolong the effects of the Benadryl and it doesn't seem like anything is working. patient started feeling slightly itchy at the injection site after the vaccine. I waited the 15 minutes after the injection without having any serious side effects. By the time I got home, my arm had swollen and developed hives 02Apr2021. received Benadryl and an Epi pen. By that time, the rash and hives had spread throughout my body, and my arm, hand, and tongue had swollen. was having trouble breathing and was taken to the ER. On Sunday evening, had a relapse and it started with nausea. Within 30 minutes, was itchy and my tongue started swelling. Patient had Blurred vision; Face and skin are red; Lips tingling; Not really wanting to eat dinner on 05Apr2021; the patient not receive any other vaccines within 4 weeks prior to the COVID vaccine; List of any other medications the patient received within 2 weeks of vaccination: Adderall; Prior to vaccination, the patient diagnosed with COVID-19 was Unknown; Since the vaccination, the patient not tested for COVID19, The patient received treatment for all events except events blurred vision; face and skin are red; tingling lips; appetite lost. The outcome of the events blurred vision; face and skin are red; tingling lips; appetite lost was unknown; rest of the events was not recovered.

Onset of arm heaviness 45 min after injection Mild fatigue 4 hours after injection Arm swelled x2 in size, retained small amount of fluid 24 hrs after injection Arm swelling down by half, bruising of underside of arm/armpit 48 hrs after injection Eyelids slightly blue in hue/appearing almost bruised 72 hrs after injection Days 4-6 mild to moderate fatigue, difficulty sleeping Day 7 moderate sore throat

Received COVID vaccine (Pfizer) 3 days prior to admission which was followed by subjective fevers and chills x 2 days but no longer endorses this. Had a headache one day prior to admission that resolved with tylenol. Reports that he has hx HTN but home BPs (which he takes infrequently) have been 140s-150s systolic in the past. Has never been on meds for blood pressure. Chest pain was substernal 5/10 lasted 2 hours and believes it relieved with his blood pressure coming down. Does not describe any other alleviating factors. It was nonradiating, just happens for have left arm pain after vaccine that was present prior to chest pain.

Patient called two days after receiving the vaccine and state he was experiencing swelling in his legs and ankles (along with fatigue, nausea, and fever)

A day after the vaccine I noticed pain in my armpit. I looked at my arm and I have roughly a golf ball sized lump in my armpit. It's pretty tender when I touch or move my arm abruptly. From what I've researched it seems like a fairly normal reaction, but I still want to report it. I've taken ibuprofen and tried icing it to help with the swelling.

Aside from the expected soreness in the arm and short lived fevers, I started to develop painful swelling and hard lumps in my lymph of the same armpit as my injection site. It was quite painful and broke out into a puss-tipped rash and continued to get worse. It has been over 20 days now and instead of getting better, it has spread to my other armpit now. I went to the local advanced urgent care clinic who ran some bloodwork and said my white cell count is normal and non-indicative of lymphoma, so I was put on prednisone and doxycycline. The medication has done next to nothing and I was told that there was nothing else they could do. The pain in the arm varies per day but there are some days where it is too painful to use my arms at all.

Two lumps above clavicle suspected to be swollen lymph nodes on the left side (same side of vaccine injection). One lump is soft and moveable, and one is pea sized and it is firm and also moveable. Both lumps are painless. Discomfort and tension on the side of the neck where the swollen lymph nodes are. I noticed the lumps about two weeks after the first vaccine dose. The day after the second dose, the lumps swelled a bit more and neck tension increased.

I started with significant pain in my left arm at the site of injection the day after injection. The day after I had significant swelling and pain in the lymph nodes in my axilla. This pain last for 3 days. After the pain in axilla resolved I started with significant post nasal drainage. So, 4 days after my shot I developed cold/flu like symptoms. These were very similar to the symptoms I had after actually contracting covid 19. These symptoms have now been present for 4 days. I have no chills or fever. I have had aches, severe sore throat, sinus pressure, nasal congestion.

On Monday May 3rd I woke up with bloodshot eyes and my lip was starting to swell. It was 12 days after receiving the 1st covid shot. Once Thursday May 6th arrived I was having a full on herpes breakout. Cold sores on my top lip and lesions/fever blisters on my tongue, multiple. I have never had an oral herpes outbreak before in my life so I didn?t even know that I had it in me until now.

Shortness of breath, rapid heartbeat, tiredness and weakness, tingling in the face and extremities, could not articulate, swelling on the right side of the face.

No treatment. The lymph knot showed a swelling between chest and armpit. It is still swollen a little bit, but much better than this morning and the pain is not there anymore.

Cognitive -- severe symptoms began ~3 days after Pfizer 2nd dose. Extreme disorientation and confusion (transient), memory loss (longterm), extreme lethargy - unable to move, intermittant psychosis (mild, esp. when going to sleep), and anxiety (transient but very extreme, unlike anything I've felt before, not improved by diazepam) (continued for 10 days then began to improve dramatically followed by alternating relapse on a daily basis for 4 weeks, up to present -- dramatically and stably improved by steroid treatment, returned after discontinuing) Nerve pain -- began ~1 week after Pfizer second dose. -- tingling, burning throughout extremities, especially fingertips, toes, hips; transient (usually 5 seconds or less). Progressively became more frequent (20+ / day), longer lasting (up to 20 seconds) and more severe (like stabbing or electric shock). Gradually resolved after course of dexamethasone beginning 3 weeks after vaccination. Sharp inner ear pain -- (both ears) began ~1 week after Pfizer second dose. Rare events (~5x / day), very transient (1-2 seconds) but extremely painful. Continues up to present, (4 weeks after Pfizer second dose). Also constant popping of both ears beginning week 2 to present, feels like fluid inside. Adenopathy -- On 4/28/21 noticed massive swelling on left pectoral muscle (contralateral to vaccine injection site), diagnosed as lymphadenopathy, moderately painful. Continued to get worse for 1 week, began dexamethasone on 5/7/21. Dramatically improved, however swelling returned after discontinuing steroid and spread to all lymph nodes, including neck and others. Became extremely painful on 5/14/21, unable to walk due to swelling in inguinal lymph nodes. Again dramatically improved after steroid injection on 5/16/21.

Myopericarditis with chest pain onset 3 days after vaccine dose #2. 1 day after dose #2, patient experienced fevers and chills.

3 days after 1st shot Severe joint pain (Similar to RA), muscle pain, Headaches that lasted from 4/9/21 to 5/13/21 when I was taken to the hospital where it was found I had a Venous Stroke. Multiple doses of steroid, and Tylenol until the stroke, then I don?t recall what I was given in the hospital but now I am on 80mg of staton, 81mg of aspirin, 1mg of folic acid

On days 1 and 2, I experienced normal symptoms from receiving the vaccine, fatigue, joint and head aches that lasted through the weekend and up to day 5. On day 5, I noticed unilateral lymphedema of my tonsils. On day 7, I went to an Urgent Care but didn't get much treatment. My condition worsened, I was fatigued, no appetite and thirsty. On day 8, I popped a fever of 103. On day 9, it worsened to the point that it was hard to breathe. I went to the ER on 10 and had a full array of tests. I was treated with dexamethasone and a bolus saline IV. My symptoms went away after treatment around day 14, but the lymphedema lingered for awhile longer.

The following day after the second shot. I had started to get serious pain in the armpit/swollen lymph node. I have had swollen lymph nodes in the past for certain infections so theres a chance I have a predisposition to getting them, but haven't had an issue in many years. However, I reached out to a friend that works for a company and she said to report this. The deep lymph node in my left armpit is many times larger than the left and I cannot let my arm rest at its side due to the size and pain.

Body aches, lymphadenopathy, fatigue, subjective fever, diarrhea, from 24 to 48 hours post injection. Mild positional chest discomfort starting several days after injection, with feeling of chest fullness after exercise lasting approximately 2-3 weeks Patient is a medical student and did not seek medical care. Took ibuprofen for symptomatic relief

I had difficulty swallowing my saliva, and notes asymmetric left sided tongue swelling, swelling of the left cheek. I have never had similar symptoms in the past. I have no dyspnea, fever, chills. I was admitted to ER then transferred to ICU, doctors gave me some steroids and anti-histamine treatment. After around 5 hours my swellings were all gone. But doctors kept me in hospital for several days for safety and discharged me after 5 days.

Two days following vaccination, patient had increasing substernal chest pain and was admitted to hospital following day

Significant lymphadenopathy noted on left cervical nodes and clavicular nodes. First noticed about 10 days after vaccine given. Has persisted.

Cervical and clavicular lymphadenopathy on the left side; Some tenderness in neck; This is a spontaneous report from a contactable physician (patient). A 29-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number and Expiration Date were not reported), via an unspecified route of administration in left arm, on 17Dec2020 at 11:45, at a single dose, for COVID-19 immunization. The patient had no medical history and no concomitant medications. The patient had no known allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The most recent COVID-19 vaccine was administered in the hospital. On 27Dec2020, the patient experienced cervical and clavicular lymphadenopathy on the left side (same side as the vaccine shot was received). The patient first noticed some tenderness in neck about 10 days after vaccine was administered. The events were considered non-serious. No treatment was received for the adverse events. Since the vaccination, the patient has not been tested for COVID-19. The patient had not recovered from the events. Information about lot number and expiration date for the suspect product will be requested in follow-up attempts.

Lymphadenopathy in left axilla starting approximately 6 hours after vaccine and lasting for about 3 days. Self-limiting, Tylenol used for symptom control/pain

eyebrows swollen; area of his eyebrows is swollen and resting right on his eyelids; lymph nodes swollen; This is a spontaneous report from a contactable consumer reported for himself. A 29-year-old male patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730 and expiration date: 31Mar2021), via an unspecified route of administration on arm left on 09Jan2021 11:45 at 0.3mL, single for covid-19 immunisation. The patient medical history reported as none. There were no concomitant medications. The patient previously took Influenza Quadrivalent (lot number: 294G5 and expiry date: 30Jun2021) at the age of 29-year-old on 20Oct2020 at 0.5mL and never had any problems. The patient having a side effect from the dose he got on Saturday 09Jan2021. He woke up yesterday on 11Jan2021, with his eyebrows swollen, the area of his eyebrows is swollen and resting right on his eyelids. Also reported woke up yesterday on 11Jan2021 with the swollen eyelids and swollen lymph nodes, are a little swollen but have seemed to subside as of today. The outcome of the events swollen eyelid and swollen lymph nodes was recovering, outcome of the other event was not recovered.

Hives; itching; swelling of feet, hands; swelling of axilla, buttocks; redness on hips, worsening after 1 week after second dose; administration date: 17Dec2020 / administration date: 05Jan2021; fever; chills; fatigue; malaise; body aches; headache; tinnitus; This is a spontaneous report from a contactable nurse (patient). A 29-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK9231; expiry date: unknown) via an unspecified route of administration in the right arm, on 05Jan2021 at 16:00, at a single dose, for COVID-19 immunization. Relevant medical history included known allergies to poison ivy/ poison oak. Concomitant medications included finasteride. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK5730; expiry date: unknown) on 17Dec2020 at 14:00 in the left arm for COVID-19 immunization. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in the hospital. On 05Jan2021, at 20:00, after second dose, the patient experienced hives with itching and swelling of feet, hands, axilla, buttocks, redness on hips, worsening after 1 week after second dose. On an unspecified date in Jan2021, for a 3-day period after second dose, patient had fever, chills, fatigue, malaise, body aches, headache, tinnitus, all since resolved except hives worsening. The patient did not receive therapy for the events. Outcome of the event hives was not recovered, for event "administration date: 17Dec2020 / administration date: 05Jan2021" was unknown, while for the other events was recovered. The patient has not been tested for COVID-19 since vaccination.

12hr after second dose: increased pain at injection site, but no swelling or redness; headache; Discomfort is a 6/10; gradual onset of soreness raidiating from lymphnodes in neck; gradual onset of soreness in chest/ soreness in bronchi; gradual onset of soreness in back; gradual onset of soreness in hips; gradual onset of soreness in legs; gradual onset of soreness in glutes; soreness in upper lungs; soreness in upper respiratory system; This is a spontaneous report from a non-contactable consumer. A 29-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EL3247), via an unspecified route of administration on the left arm from 18Jan2021 at a SINGLE DOSE for covid-19 immunisation. Medical history included major depression, anxiety; increased airway sensitivity due to being former smoker from an unknown date and unknown if ongoing. Concomitant medication included vilazodone hydrochloride (VIIBRYD), loratadine (LORATADINE), theanine (THEANINE). The patient previously received the first dose on 28Dec2020 (Lot number=EK3730). There were no noticable effects after the first dose but 12hrs after second dose (19Jan2021), the patient experienced increased pain at injection site, but no swelling or redness. There was gradual onset of soreness raidiating from lymphnodes in neck, chest, back, hips/glutes, and legs; headache; soreness in upper lungs/bronchii (they are hypersensitive and usually sometimes get sore in reaction to irritants in the air), as well as upper respiratory system, but no difficulty breathing. Discomfort was at 6/10 on 19Jan2021. The outcome of the events was not recovered.

slight left armpit swelling and pain; slight left armpit swelling and pain; chills and slight aches 12 hours after 2nd injection; chills and slight aches 12 hours after 2nd injection; This is a spontaneous report from a contactable nurse (patient). A 29-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231, expiry date not reported), via an unspecified route of administration in the left arm on 24Jan2021 at single dose for COVID-19 immunization. Medical history was not reported. Concomitant medications were none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was vaccinated at a hospital. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The patient had no allergies to medications, food, or other products. The patient previously received first dose of bnt162b2 (lot number: EK5730, expiry date not reported), intramuscular in the left arm on 04Jan2021 07:45 AM at single dose for COVID-19 immunization. On 24Jan2021 22:30, the patient experienced chills and slight aches 12 hours after 2nd injection. On 25Jan2021, 24 hours after 2nd injection, the patient experienced slight left armpit swelling and pain. No treatment was received for the adverse events. Clinical outcome of the events was not recovered.

Pt got the vaccine on 3/17 and called today 3/21 to tell us he was having a reaction. He said his armpit on the same side of the shot (left) started to swell 24 to 36 hours after the shot. He had some edema and pain. The past 2 days, he states that the swelling moved down to his left abdomen. He has no fever, shortness of breath or any other symptom. I referred him to a doctor and he is going tomorrow.

After arriving at home after getting the shot, I began to have flu-like symptoms. This included an extremely sore throat with very swollen glans. My throat is/has been red with pus-like pockets on the inside of my throat. In addition to the throat issues, I have been extremely lethargic, with sensitivity to light and sound. I have had all of these symptoms for 6 days now. I also have had lots of diarrhea but that cleared up after 3 or 4 days.

Developed facial swelling, sneezing, throat irritation possibly throat closing, itchy eyes; reaction started 3hrs later. Took non-drowsy claritin. Reaction resolved after 3 days decreased incrementally. Had idiopathic anaphylactic reaction in the past 6-7 yrs ago.

Left axillary lymph node inflamed, red, and tender. 4.5 cm x 2.0 cm. Difficulty moving left arm due to pain. Patient has taken Ibuprofen and Tylenol PRN. He also did warm heating pad. No improvement.

pt got first covid shot on 3/20/21 then 2nd shot on 4/10/21. Pt didn't have any side effects after the first shot. For both shots pt got it in the left arm. About 9 days after the 2nd shot of the vaccine pt intially had sore throat, cough and head ache but resolved, pt also had a rash on arm that resolved too. Pt did have one bout of mild diarrhea before admission to hospital on 4/19/20. Pt admitted to hospital on 4/19/20 for tachycardia and on and off fevers since getting the 2nd shot of the vaccine. PCT 0.3 and 0.2 on 4/20, 4/21 respectively. wbc= 23.69 and 16.6 on 4/19 ,4/21 respectively. Working diagnosis at discharge per ID note is prolong side effect to covid vaccine. Pt discharge from hospital on 4/21

"Covid Arm." Swelling and Rash started on April 23rd one week after vaccination. No Pain or itchiness, is going away slowly.

A few hours after his vaccines he noticed swelling inside his arm pit versus on the outside of his shoulder area. He was concerned enough to call us. Afterwards, he did call his PCP who stated this is a side effect noticed (not super common but can happen) I suggested a warm compress.

unprovoked right leg DVT; bilateral PEs; Factor V Leiden positive (hetereozygous); right leg swelling and pain progressively worsening; right leg swelling; This is a spontaneous report from a contactable consumer (patient). A 29 year old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 19Jan2021 10:00 (Lot Number: EL1283) as SINGLE DOSE for COVID-19 immunisation. The patient previously had first dose of BNT162B2 on 29Dec2020 at the age of 29 years old for COVID-19 immunisation. Medical history included pleural effusion w/ thoracentesis x2 (5 years ago), known allergies: penicillin and sulfa drugs from an unknown date and unknown if ongoing. Concomitant medication included armodafinil taken for an unspecified indication, start and stop date were not reported. The facility where the most recent COVID-19 vaccine was administered was in the workplace. 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 (nasal swab): negative on 28Jan2021. On 28Jan2021, the patient presented to the ED with right leg swelling and pain progressively worsening over the past week. Subsequently diagnosed with unprovoked right leg DVT and bilateral PEs, admitted overnight and given anticoagulation therapy. Labs ordered and reviewed with hematology consult 1 week later and found to be Factor V Leiden positive (hetereozygous). Treatment plan therapeutic dose of Eliquis twice a day for 1 year, prophylactic dose indefinitely after that. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care and hospitalization. The events were reported as life threatening illness as patient was in immediate risk of death from the events. The patient was hospitalized for 1 day. The events was recovering. The events was treated with anticoagulation therapy, pain medicine and stockings.

Experienced racing heart rate (120 bpm resting), mild chest pressure, moderate fever (102 F), chills, nausea, headache, injection site soreness, and left arm lymph node soreness. Rested, and most symptoms subsided over night. Heart rate still slightly elevated (100 bpm resting) with occasional chest pressure.

2nd dose on 5.15.21 at 5 am reports he has pain and swelling in left arm, more so in his left hand and digits. He was given Ibuprofen and calling medical professional

5/15/21 @1200: Gammaplex IV infusion started 1320: pt rang call bell for assistance, RN entered room to see pt shaking uncontrollably, pt reports that he is not feeling well, infusion stopped, and PIV flushed, VS obtained BP: 95/66 HR: 104 Temp: 100 RR: 24, Anaphylaxis kit retrieved, DON on phone assisting with walking through Anaphylaxis reaction needs/protocol 1325: 25mg (0.5mL) of Diphenhydramine given via SIVP, PIV flushed with 3mL NS post Diphenhydramine SIVP, manual BP taken at this time BP reading of 120/78 but really hard to obtain an accurate BP d/t pt shaking, Temp: 100 RR: 23, pt continues to shake, hands are cold to touch, finger tips are white with no cap refill noted, purple areas noted around pts knuckles at this time, pt reports that his feet feel tingly at this time and possibly his fingers, states that his back has a warm sensation and that he has a light feeling, pt reports feelings of being nauseated, garbage can provided for patient 1340: no improvement noted from 1st Diphenhydramine dose given, 2nd dose of 25mg (0.5mL) Diphenhydramine given via SIVP at this time, 3mL NS flushed post med, Acetaminophen 325mg x2 tabs that was dispensed for pre-med that pt declined to take was administered PO at this time, BP: 110/64 HR: 104 Temp: 101 RR: 23, continued body shakes noted, hands continued to be cold to touch with fingertips being white noted, no cap refill noted, purple areas still noted around knuckles of hands, pt still reports a warm sensation to his back, pt communicating with eyes closed most of the time, face coloring is pale 1345: pt reports that he feels like he is going to vomit at this time, pt vomited x 3 times into garbage can, 500mL Normal Saline bag per Anaphylaxis order begin at this time, rice pack heated and provided to pt for hand warming, hands continue to be cold to touch, pt continues to keep eyes closed, face continues to be pale 1347: pt reports feeling a little better at this time, lungs clear in all lobes bilaterally to auscultation, tachycardia noted via palpitation and auscultation, pt states at this time that his back does not feel as bad, color is starting to return to pt face at this time, hands continue to be cold to touch with white fingertips noted 1350: BP: 114/72 HR: 100 Temp: 101.9 RR: 20, pt breathing has decreased, pt reports that he feels like he is feeling better, pt discussed with me again that his provider stated that there was not enough information on time frame in between getting the COVID vaccine and his infusion, he also went on to report that he also spoke with another provider about getting the COVID vaccine and his infusion and that provider gave him the CDC website for him to read about the recommendations as well, he stated that both his provider and the CDC website stated that there was no recommended interval between the COVID vaccine and IVIG 1358: BP: 118/68 HR: 90 Temp: 101.7 RR: 18, color returned to face at this time, cheeks flushed, hands continue to be cold to touch but color have started to return to fingertips at this time, cap refill noted at 4 seconds, pt reports that he thinks he is feeling better at this time, states he feels that his speech is a little slower than normal, no slur noted, pt eyes are open and pt is alert, improvement in VS noted 1410: BP: 106/64 HR: 96 Temp: 101.7 RR: 18, pt reports feeling much better at this time, pt is holding conversation well and without difficulty, pt denies feelings of nausea, more color return noted to pt fingertips, cap refill noted of 3 seconds, pt reporting feelings of being drowsy at this time, reports that his back feels normal 1420: 500mL NS bag completed, pt reports at this time that he does not wish to restart his IVIG and asks if he can stay in the AIS for a little while because the Benadryl is making him super tired, pt reports that he does not have anyone that could come and drive him home, pt assured that he can stay in the AIS with RN as long as he needs 1445: BP: 104/56 HR: 106 Temp: 101.8 RR: 20, pt resting calmly, eyes were closed upon entering the rm, pt states he feels much better still, denies any new or concern symptoms at this time, states that he is just really tired, fingertip coloring has returned, cap refill less than 3 seconds noted, lungs clear to all lobes bilaterally 1500: pt resting calmly, pt opens eyes upon entrance into pt rm, pt continues to report feeling better just tired, pt denies any needs at this time 1515: no changes noted with pt, continues to rest calmly in recliner in room with eyes closed, opening eyes when rm is entered 1540: pt up to restroom 1545: BP: 104/63 HR: 102 Temp: 101.3 RR: 18, pt reports that he is feeling much better, he reports not feeling as drowsy now and that he feels okay for him to drive home, he denies any new symptoms, pt was encouraged to take Tylenol 2 tabs Q4-6 hours for temperature and body aches for the next 24 hours, pt was educated on contacting provider for further IVIG needs and rescheduling, pt educated on going to the ER if symptoms return, pt also educated on monitoring temperature at home 1550: PIV removed with tip intact noted, pt stabilized, all color has returned to hands, pt holding conversations without difficulty 1555: pt escorted out of AIS

Foot and ankle inflammation and swelling. It started out with my left foot/ankle but it is now impacting my right foot/ankle also. Currently, it has gotten to the point where I essentially can?t walk. I am having similar symptoms with my knees and right index finger but they are not as severe and not as debilitating. I am currently waiting for an appointment with a rheumatologist.

After a few hours of receiving the vaccine, I could start to feel soreness in my left armpit (lymphnode). This moved to all of left arm even all left side of body. Began feeling very tired. Less than 12 hrs after receiving 2nd dose I had to leave work early. 3:30 am the next morning I had uncontrollable shivers/tremors. To the point where I couldn't stand on my own. I had a fever of 101 degrees. As a result of the tremors I had entire body soreness. Hot flashes; alternating from sweat to freezing. Side effects began to dissipate after a full 24 hours.

His left armpit got big and swollen. He thinks it's swollen lymph nodes; This is a spontaneous report from a contactable consumer (patient). A 29-years-old male patient received BNT162B2, (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0168, Expiry date: unknown) via an unspecified route of administration, administered in arm left on 25May2021 at 09:15 as 1st dose, single for COVID-19 immunisation. The patient medical history was none. The patient's concomitant medications were not reported. There was no history of previous immunization with the Pfizer vaccine that would be considered as suspect. The patient did not administered vaccine on same date of the Pfizer suspect. The patient did not receive any prior vaccinations (within 4 weeks). On 26May2021, evening 19:30-20:00, the patient experienced his left armpit got big and swollen, he thinks its swollen lymph nodes. Response was 6 over all safety summary, lymphadenopathy (0.3%). It had not gone down much. The patient stated that he had a little fact sheet which says it was a lymph node. He asked that was there any way that he could possibly get that to go down and how long it would last. He also asked for specific medication he could take for his swollen lymph nodes. The event did not require a visit to emergency room or physician office. There was no family medical history relevant to adverse event. The patient did not undergo relevant tests. The patient did not receive treatment for the event. The outcome of the event was unknown.

Swollen lymph nodes within 5 minutes. After 3 hours, malaise, dizziness, fatigue, weakness, chills, nausea. Symptoms worsened over the past 10 days. Uncontrollable and inexplicable panic attacks, debilitating episodes of sickness.

My left armpit swelled up to a baseball cut in half size. Very painful to the touch at times.; My left armpit swelled up to a baseball; Second dose on 07Jun2021, first dose received on 24May2021; This is a spontaneous report from a contactable consumer (patient). A 29-year-old-male patient received second dose of bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Right on 07Jun2021 14:00 (Inappropriate schedule) (Lot Number: Ew0179) as single dose (at age of 29-year-old) for covid-19 immunisation. Medical history was not reported. Concomitant medications included paracetamol (TYLENOL); celecoxib (CELEBREX). The patient previously took gabapentin and experienced hypersensitivity, pregabalin (LYRICA) and experienced hypersensitivity. First dose of bnt162b2 (BNT162B2) was administered on 24May2021 at 13:00 (at age of 29-year-old) in Left arm for covid-19 immunisation, lot number: Ew0179. The patient did not receive any other vaccines within four weeks prior to the vaccination. Patient did not have COVID prior vaccination and also patient was not tested for COVID since the vaccination. Patient stated that on 08Jun2021 08:00 his left armpit swelled up to a baseball cut in half size. Very painful to the touch at times. No treatment was received. Events resulted in Emergency room/department or urgent care. Patient had not recovered from the events.

GBS with ascending polyneuropathy causing paresthesias and weakness treated with IVIG at discharged to rehab had aspiration and worsening weakness again then brought to MGH, requiring intubation

Patient experienced significant swelling of arm, back, and facial region, headache, reports kidney pain and lip and throat numbing, as well as overall body aches. Patient took Benadryl 50mg to reduce swelling with success. Symptoms subsided completely after 4 days.

Malaise and joint aches for 1.5 days. Right upper axillary (proximal armpit area) lymph node swelling and tenderness for around 3-4 days then gradually less pain with dissipation of swelling over 2-3 days (after initial 3-4 days) before back to normal.

Fever, to T max 101.5 lasting approximately 24 hours, antipyretics used, malaise, mild tender lymphadenopathy

Three days after second immunizations, spontaneously developed diffuse urticaria on my trunk and face. Associated w/itching, mild abdominal discomfort, and facial swelling. Symptoms somewhat improved w/cetirizine. About 24hr later, had recurrent diffuse urticaria, predominantly in the face. Still having persistent intermittent sweats and significant fatigue.

Dose 1 on 12/15- Sore arm for three days after vaccination. Swelling also was present on the deltoid. Upon resolution a large bruise showed up. Dose 2 on 01/05- Sore arm near vaccination site at 12 hours. At 15 hours out woke up in middle of the night with diffuse body aches and chills. These progressively worsened. Fatigue also present in the morning with very mild fever. Developed nausea the next day as well. At 36 hours out body aches were improving but a headache developed at ~ 30 hours out. Next morning 2 days out the only thing thing that persisted was fatigue. This was gone another 12 hours later. No persistent symptoms.

The evening of 1/10 I spontaneously developed diffuse urticaria of my trunk and face, associated with itching, mild abdominal discomfort, and facial flushing. Symptoms somewhat improved with cetirizine. The evening of 1/11 developed recurrent spontaneous diffuse urticaria, mostly in the face. Having persistent intermittent sweats and significant fatigue. Per Patient, He have had urticaria rarely in the past, associated with shellfish. I have never had anaphylaxis before.

About any hour after sore throat left side , headache ,stomachache ,chills, throughout next day swelling in throat neck and face left side very hard and painful to swallow ,eat , drink felt like a golf ball was in my throat. By 3rd barely ate only had soup and a mild case of diarrhea , day face neck throat pain still and swelling , warm wash clothe hot fluids help with pain, 4 day cold things help reduces swelling in face and throat, neck still swollen and a lot more pain in face jaw , neck, still hard and painful to swallow. Current day a lot of pain in jaw neck throat face still only happening on left side of body more pain then before but less swelling neck still swollen a little bit. I tried cough drops soup heat ice and still having pain don?t want to pay for an ER visit found old painkillers haven?t taken yet. How long do symptoms like these last for ? I take medication for ADD and that masks pain to make it bearable. What do you recommend to do if I don?t want to go to the ER ?

I developed a moderately tender, golf-ball sized left axillary lymph node starting 48 hours after the vaccine, peaking around 72 hours, and lasting until 7 days after the vaccine. The degree of tenderness (3/10 at rest, 6/10 with manipulation) precluded tight clothing and laying on the left side of my body but was tolerable. I monitored it myself and it resolved spontaneously. There was no other LAD noted. I know LAD is one of the known side effects, but I thought this might be a more severe case than usual.

Swelling of supraclavicular lymph nodes - swollen to about the size of grape following 2nd COVID vaccination. Soft and moveable with swelling around the site at base of neck/above clavicle. Onset after high intensity exercise, reduced swelling with rest but, still present.

axillary lymphadenopathy; This is spontaneous report from a non-contactable consumer reporting for himself. A 30-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EL324), via an unspecified route of administration on 23Jan2021 at SINGLE DOSE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. 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 has no known allergies. The patient experienced axillary lymphadenopathy on 24Jan2021. No treatment was received. Outcome of the event was recovering. The reporter assessed the event as non-serious. No follow-up attempts are possible. No further information is expected.

Itchy, redness, bad swelling, warm to touch, extremely sensitive, pain with some movements, 2.5 inch circumference of redness, 5.5 inch circumference of hard swelling

Fainting episode; Loss of hearing; Left collar-bone lymph node enlarged noticeable swelling to area and left lower neck near carotid artery/lymph nodes; Soreness in area; Cold sweats; Light-headedness; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 08Feb2021 at 07:00 (at the age of 30-years-old) as a single dose for COVID-19 immunization. The patient did not have any relevant medical history. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient had no symptoms until 5 days post vaccination. On 13Feb2021 at 12:15, the patient experienced fainting episode, loss of hearing, left collar-bone lymph node enlarged (noticeable swelling to area and left lower neck near carotid artery/lymph nodes), soreness in area, cold sweats, and light-headedness. The events required a visit to the physician's office and emergency room (as reported). The clinical outcomes of the fainting episode, loss of hearing, left collar-bone lymph node enlarged, soreness in area, cold sweats, and light-headedness were unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.

Patient developed a rash 7 hours after receiving vaccine that resembled hives on his arms, tingling lips, and facial swelling.

Body aches. sharp pain in finger joints. Sharp pain in joints. Pain in bones. Fatigue. Pain at injection site. Swollen painful lymph nodes in the armpit of the same arm of the injection site. Headache after 24 hours. Neckache. Shoulder pain.

Swollen lymph nodes under left arm pit. Symptoms started the next day and it has not gone away. It gets worse every time I work out.

Rashes on both of my arms and swollen feet. My left foot is the worse. Have seen a specialist who recommended me to contact.

took him a half an hour just to get out of bed; Tightness to left trapezius and left side of neck, same side as vaccine; increased pain and decreased range of motion to his neck; increased pain and decreased range of motion to his neck; inflammatory infectious process with atypical organisms; Lymphadenopathy/ compressing the nerves in his neck and causing his pain and decreased range of motion; This is a spontaneous report from a contactable nurse (patient). A 30-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: ER8730) via an unspecified route of administration, administered on the left arm on 31Mar2021 15:00 at a single dose for COVID-19 immunisation. Medical history included ongoing hypothyroid. Concomitant medication included levothyroxine sodium taken for hypothyroid. The patient previously received tetanus vaccine (6 weeks out from his Covid Vaccine) with no adverse events. Patient stated that his side effects began on 01Apr2021. He noticed tightness to left trapezius and left side of neck. This was the same side of the body he got the vaccine on. His symptoms worsened over the next two days. He had increased pain and decreased range of motion to his neck. On Saturday 03Apr2021. it took him a half an hour just to get out of bed. Stated that he went to the Emergency Room at the hospital where he works and they did a series of tests. He had CAT Scans with and without contrast, a MRI, and an Ultrasound. Mentioned later that they also did blood work (Apr2021). The Emergency Room doctor told the caller he was going to have his CAT scan read by a specialist. Caller stated they called him on Sunday 04Apr2021 and said his CAT scan showed an inflammatory infectious process with atypical organisms and Lymphadenopathy. He stated that he read that Lymphadenopathy was a side effect of the vaccine. They told him that the Lymphadenopathy was compressing the nerves in his neck and causing his pain and decreased range of motion. He had been on a week of treatment consisting of pain medications, muscle relaxers, and anti-inflammatory medications. The Infectious Disease was consulted and he was started on a 5 day course of Azithromycin. He was on the third day of this antibiotic per his report. He has a follow up MRI scheduled next Friday. He was calling to report his side effects and also to ask about what he should do in regards to his appointment for his second dose of the vaccination. His symptoms were worsening for the first three days. Since he has been being treated for them they have started to improve slowly day by day. Today he said there was minimal pain and tightness but he was still not back to one hundred percent. He was offered admission to the hospital for pain control after his emergency room visit but he decided to defer it to an outpatient setting. Was not admitted to the hospital. The patient felt that the events 'tightness to left trapezius and left side of neck, same side as vaccine'; 'increased pain and decreased range of motion to his neck' were medically significant and stated they were disabling, at least temporarily. There were no additional vaccines administered on same date of Pfizer suspect. Outcome of the events 'tightness to left trapezius and left side of neck, same side as vaccine'; 'increased pain and decreased range of motion to his neck' was recovering while unknown for the other events. Patient stated that he felt all of his adverse events were caused by the COVID Vaccination he received.; Sender's Comments: A contributory role of BNT162B2 to reported events cannot be excluded based on the temporal relationship. Case will be reassessed if additional information is received. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified.

Myocarditis, started with fever and chills on 2/20-21, ultimately hospitalized on 2/27-3/6 at hospital transferred to medical center for higher level of care. Required dobutamine. Underwent R and L heart cath as well as endomyocardial biopsy, which was consistent with lymphohistiocytic myocarditis.

Arm swelled and redness below the vaccination site. Eye muscles weakened and could not hold eye opened on vaccination site side.

Patient presents to ER with a complaint of facial swelling, tightness in throat and chest, and shortness of breath. Patient states that his symptoms first began yesterday (4/27) at approximately 1400 shortly after receiving his first dose of the Pfizer Covid vaccine. Patient was seen in the ER for this yesterday, was treated and released. Patient was given prescription for prednisone to take at home, however states that he has not filled or started this prescription yet today. He states this morning he started to have some returning chest and throat tightness, redness around his chest and face, and shortness of breath. He states symptoms of been constant since onset. He states he took a single p.o. Benadryl and used his albuterol inhaler at home, with minimal relief. At this time patient is reporting some mild dyspnea with intermittent nonproductive cough, mild throat tightness, and redness to the skin. IV Solu-Medrol, Pepcid, Benadryl, IV fluids, nebulized breathing treatment. Symptoms improved in the ER, no longer shortness of breath. Pt to continue PO steroid

Patient called center and reported swelling 3cm below his armpit that appeared yesterday 24h s/p his 1st Pfizer dose. He has a prior hx of COVID-19 infection. The swollen area is approx 2-3"" in diameter, mild discomfort when touched or when moving arm, no fever, no change in color or warmness to touch, skin intact. No visible change in size or pain level over the past 24 hours. RN told client that it is not a known SE and that immediate eval is not needed unless his condition changes. RN advised him to use ice and cold compresses for relief and to outline the area with a marker to allow him to gauge if it increases or decreases in size. RN advised him to go to a UCC or ED if it suddenly gets larger, fever of over 100.4 develops or pain increases in intensity. Pt has a phone appointment scheduled with his outside PCP 4/23/21 to discuss his concerns.

Got COVID shot. Next morning woke up with a swollen collarbone lymph node. Felt ok in the morning. Not warm to the touch or sore. No physical allergic reaction like hives or redness, just a lot of fluid in the node.

Injection on may 6th, on my seventh around 12pm, lymph nodes near ear and below jaw became wnlarged and sore,, noticed red hot itchy spot on left cheek. Progressively expanded through the day, accompanied by fever, body aches. Each day has gotten progressively worse. Rash spreading to scalp following day and migrating left to right across face. May 9th went to emergency room for treatment. Prescribed zyrtec, benadryl and prednisone along with Valtrex. Unable to identify cause of rash. As of May tenth the rash has continued to grow and is now on spread to the top of my scalp, back of my skull and pain as shown up in nerve in jaw on right side

A swollen nymph node appeared at the base of the neck on the left side at the collar bone. First notice, about the size of a lima bean. Node was monitored for stiffness or unusual pain, and over time, the node began shrinking to the size of an english pea, and then to the size of a black-eyed pea. During pre-screening for the second dose, patient was cleared to receive the dose, but advised to continue monitoring, and report any changes. Since the second vaccination, the node has returned to the size of a lima bean, with soreness. Now the soreness has reduced, and the node is still able to move around when probed.

I didn't get any swelling around the injection sight, but I got swelling in the lower and mid area of my armpit. Maybe the lymph nodes are just reacting to the shot. Just wanted to report just in case it hasn't been recorded yet.

Pt felt dizzy & light headed. c/o middle back hurts. 2:55 PM - Lymph nodes on throat felt swollen. Noted tonsils are slightly enlarged but uvula is WNL & breathing w/o difficulty. BP 146/79 P 59. 3PM - Left w/o assistance.

Low grade fever - Tuesday to Saturday Extreme headache: Tuesday Body aches, cold sweat, and minor headache: Tuesday - Saturday Blood Clot found in my leg behind my knee Saturday (today). Symptoms of pain and swelling started Tuesday. Reached high pain point Thursday and it didn't get better so I was recommended to go to the emergency room.

I am seeing swelling in left lymph gland- near the collar bone; This is a spontaneous report from a contactable consumer (patient). A 30-year-old male patient received BNT162B2 (Lot Number: EW0170), via an unspecified route of administration, administered in left arm on 22Apr2021 09:00 (at the age of 30-year-old) as 2nd dose, single for COVID-19 immunization. The patient medical history was not reported. The patient had no known allergies. Concomitant medication included paracetamol. The patient previously received the first dose of BNT162B2 (Lot Number: ER8737), administered in right arm on 31Mar2021 15:00 (at the age of 30-year-old) as single dose for COVID-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient was seeing swelling in left lymph gland- near the collar bone on 09May2021 19:00. The event resulted in Doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the event which included an antibiotic that was prescribed by doctor, Cefdinir 300mg. The outcome of the event was not recovered.

fatigue, headache, body aches, joint aches, fever to 101 degrees, sweats, swollen lymph nodes left axilla

Patient came in having tenderness under left armpit. Upon examination, patient had what looked like a swollen lymph node. Patient had swelling of about the size of a baseball at left armpit. This was compared to his right side which looked normal. Instructed patient to seek a physician for further examination.

30 YO M with no PMH who presented on 4/27 with left arm pain after covid vaccine on 4/15. He reports he developed left arm swelling and redness that was progressive following the vaccine. He is now s/p I&D at El Camino on 4/28. Patient with multiple apparent debridement sites 3x around elbow and 1x left deltoid. Continues to have pain and swelling around elbow and in shoulder. No sensation changes, compartments are soft. He was subsequently taken to the OR on 5/4 for debridement with return trips on 5/5, 5/6, and 5/7 with vac placed on 5/7. He tolerated bedside vac change to left deltoid and WTD to 3 sites around elbow. He lives at home alone and is unable to do dressing changes by himself. Wound vacs were placed on all wounds and home health was arranged for MWF visits. In addition, he will follow up in wound care clinic as outpatient. He understands he needs to complete course of oral antibiotics and will have pain meds for vac changes. He was stable upon discharge

2nd Dose: Experienced first symptoms around 6:00pm on June 24, including severe headache and moderate general weakness. Around 9:00pm experienced mild shortness of breath and moderate lymph node swelling under injection arm armpit which carried into June 25. This report is being submitted on June 25 and the mild shortness of breath and armpit lymph node swelling is still present. 1st Dose: Mild to moderate weakness and fatigue day after the first shot (June 3, 2021) with no additional symptoms. Symptoms completely resolved by June 4.

I had the vaccine on 06/22/2021. What brought me in was nasal congestion, ear pain, no fever, sore throat, runny nose and a little bit of chest tightness. I went to urgent care the following day on 06/23/2021, I went to get a Covid test that day and it was negative. Basically, they said my ears looked fine, my lungs sounded fine, my throat seemed a little bit red but was fine. They said to come back if the symptoms persisted. I was getting progressively worse through out the week to where my throat was in pain, I started taking allergy medicine and that did not impacted my symptoms. After several days of getting progressively worse, on 06/27/21 I went back and they told me I had swollen lymph nodes under my jaw and a lot of fluid in my right ear which was causing the ear pain but my lungs sounded fine but my sore throat was extremely red. She felt that it was probably not related to the vaccine because of how far it was from when I got it. She prescribed Erythromycin thinking it was a bacterial infection. I been on the course on that since Sunday. I am definitely improving but I am still pretty well congested but my ear pain has resolved.

It started out as very bad shoulder pain with a bit of swelling, but shortly after I could feel a tightness when my arm was held all the way outward. The next morning, the top of my ring finger felt numb and as the days progressed it moved to the whole finger and the finger tip of my middle finger as well. I have not regained any of feeling that I lost

Entire back hurt; Left arm sore; Left armpit swollen a bit; Cold; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 30Apr2021 at 03:15 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. The patient did not receive any concomitant medications within 2 weeks of vaccination. The patient previously took shellfish. Prior to the vaccination, the patient was diagnosed with 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 vaccination. On 01May2021 at 00:15, the day after shot, the patient experienced that his entire back hurt, on a pain scale it was 6/10, had left arm sore, left armpit swollen a bit and cold most of the day. The clinical outcome of the events entire back hurt, left arm sore, left armpit swollen and cold was resolved on an unknown date on May2021. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

1/5/21 Within 10 min, started hot flash, right side of face was numb but was not paying attention and went to visit his wife and mother in hospital and came back to the clinic. Noted right facial swelling, right leg felt off, no blurred vison, no difficulty with swallowing. Staff walked to the ED. Gave Benadryl IM given, Steroid IM given. Discharged from ED about 1400

Pt report fever of 100.6, left shoulder blade pain and swelling of the left arm pit. Treatment include Tylenol will continue to monitor.

20 minutes after injection-had hot flash and then right side of face with numbness and then swelling; no tongue swelling or airway swelling. Was treated in the emergency room at Hospital and was given IV Benadryl and Decadron

Arm pain; swollen and tender supraclavicular lymph node (injection side); swollen and tender supraclavicular lymph node (injection side); general fatigue; sinus congestion; This is a spontaneous report from a contactable other healthcare professional (patient). A 31-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), with the first dose on 15Dec2020 and second dose on 05Jan2021; both intramuscular in the left arm at a single dose for COVID-19 immunization. The patient's medical history included penicillin allergy and lactose allergy. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. On 05Jan2021, the patient experienced arm pain, swollen and tender supraclavicular lymph node (injection side), general fatigue, and sinus congestion. No treatment was received for the adverse events. Outcome of the events was not recovered. The events were considered non-serious by the reporter. Information on the lot/batch number has been requested.

Painful axillary lymph node swelling; Painful axillary lymph node swelling; This is a spontaneous report from a contactable physician reporting for himself. A 31-year-old male received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number: ek9231/expiration date: not provided), via intramuscular route of administration, on 06Jan2021 at 08:00 AM (at the age of 31 years old) as a single dose in the left arm for COVID-19 vaccination. Relevant medical history was none. The patient did not have any known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication was not provided. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: not provided), via an unspecified route of administration, on 07Dec2020 at 08:15 AM (at the age of 31 years old) as a single dose for COVID-19 vaccination. The patient did not receive any other vaccines within 4 weeks prior to the second dose of COVID vaccine (except for the first dose of BNT162B2). On 08Jan2021, at 04:00 AM, the patient experienced painful axillary lymph node swelling, ipsilateral to injection. The patient received ibuprofen as treatment for the event painful axillary lymph node swelling. The outcome of the event painful axillary lymph node swelling was recovering. Since the vaccination, the patient had not been tested for COVID-19.

The evening after the vaccine, Chills, muscle aches and "hung-over" feeling. Approximately 16 hours later, arm pain and swollen lymph nodes in injection arm.

Patient developed dry heaves followed by angio edema of the tongue, slurred speech. Patient admitted to the ED and treated with 2 doses of SQ epi, IV pepcid and IV benadryl. Patient recovered and was discharged home with an epi pen.

Chills; weak; hung-over feeling; pain and swollen lymph node under left arm (injection arm); pain and swollen lymph node under left arm (injection arm); This is a spontaneous report from a contact consumer (patient). A 31-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EL1283), via an unspecified route of administration on Jan2021 08:00 AM at single dose for covid-19 immunization. Vaccine location was left arm. Patient received the first dose on Dec2020 10:00 AM (lot number EK5730) at left arm for covid-19 immunization. The facility type vaccine was hospital. Known allergies included Penicillin. Concomitant medication included omeprazole. Patient was not diagnosed with COVID-19 prior to vaccination nor tested for COVID-19 since the vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced Chills, weak, hung-over feeling the evening after second dose. Second day, pain and swollen lymph node under left arm (injection arm). The events onset date was reported as 13Jan2021 02:00 AM. Patient didn't receive treatment for the adverse events. The outcome of events was not recovered.

Right axillary tender/painful lymphadenopathy (same arm as injection); This is a spontaneous report from a non-contactable physician. A 31-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: ek4176, expiry date not reported), intramuscular on 11Jan2021 at a single dose in the left arm for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had no COVID prior to vaccination. The first dose of BNT162B2 (lot number eh9899) for COVID-19 immunization was administered on 21Dec2020 intramuscularly on the left arm (age 31 years old). On 12Jan2021, patient experienced right axillary tender/painful lymphadenopathy (same arm as injection) 24-72 hrs after vaccination. No treatments received in response to the events reported. Covid test post vaccination included nasal swab (BD) on 15Jan2021 with negative result. The outcome of the event "right axillary tender/painful lymphadenopathy (same arm as injection)" was recovered in Jan2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Swollen lymph node in right armpit.; Tender to touch and doubled in size when compared to left armpit.; This is a spontaneous report from a contactable Other HCP (patient). This 31-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot#: EL3249) at single dose on 15Jan2021 at 02:45 PM on right arm for COVID-19 immunisation. The first dose was on 28Dec2020 at 03:00 PM at age of 30 years old, on right arm, lot number: EL0140. Medical history included Crohn's disease. Known allergies was Tegaderm. Concomitant medications in two weeks included azathioprine, verapamil. There was no other vaccine in four weeks. There was no COVID prior vaccination. There was no COVID tested post vaccination. The patient experienced swollen lymph node in right armpit on 17Jan2021 at 01:00 AM. Tender to touch and doubled in size when compared to left armpit. There was no treatment received. The outcome of events was recovering.

Same day as injection with fever, chills, headaches. Now with pressure like substernal chest pressure that is non-exertional, constant, worse with laying down. Associated symptoms includes right sided neck swelling with pain on breathing (opposite of injection site).

Swelling on the left side of my face over my Jaw/My face was severely swollen and the swelling was going down into my neck on both sides/The swelling in my face and neck had returned; Swelling on the left side of my face over my Jaw/My face was severely swollen and the swelling was going down into my neck on both sides/The swelling in my face and neck had returned; This is a spontaneous report from a contactable consumer (patient). A 31-year-old male patient received his first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EN6201), via an unspecified route of administration at right arm at the age of 31-year-old on 13Feb2021 07:00 at single dose for Covid-19 immunisation. Medical history included allergies to Sulfa. There were no concomitant medications in two weeks or other vaccine in four weeks. On Monday 22Feb2021 06:00 AM, the patient woke up in the morning with swelling on the left side of his face over his Jaw. Throughout the day the swelling increased and began to swell on the right side as well. That evening he went to an urgent care and was prescribed an antibiotic. When he woke up in the morning of Tuesday the 23Feb2021 his face was severely swollen and the swelling was going down into his neck on both sides. He went to the emergency room (ER) and was admitted overnight. He was given intravenously (IV) antibiotics, steroids and fluids. All blood tests came back normal and negative(Feb2021). When the swelling went down considerably, he was discharged on Wednesday 24Feb2021 and sent home with a steroid and antibiotic to take orally. Upon waking up this morning, on 25Feb2021 the swelling in his face and neck had returned. Adverse events were resulted in emergency room/department or urgent care and hospitalization. There was no COVID prior vaccination. The COVID tested post vaccination. The patient underwent lab tests included nasal swab was negative on 23Feb2021. The outcome of events was not recovered.

102 degree fever, body aches, severe chills, lethargy, weakness, muscle aches, fatigue, swollen lymph nodes. Rested in bed for 4 days, felt better on the fifth. I feel an onset of similar symptoms today 03/05/2021, 17 days after 2nd vaccine dose.

Roughly two weeks after injection, I started noticing inflammation in my neck and throat as well as a post-nasal drip. I had difficulty swallowing and felt pressure on my windpipe. This has diminished a bit, but has now become shortness of breath and pressure on my chest.

I've been experiencing a high fever up to 102, chills, and diarrhea everyday for the past 10 days after the 2nd dose of the covid vaccine. My UC is also flaring up worse than before. Fever goes away with tylenol.

Swollen Lymph node in left arm pit. Sensitive to touch, sore. Development was about 24 hours after receiving the 2nd dose. Other side effects were headaches and fatigue. Took Tylenol for that twice.

3/24/21 Fever and chills for most of the day. 3/25/21 Hands swollen, itchy started around 5 pm. 3/26/21 Thighs, Knees, Lower back, legs ,basically the whole lower body was swollen, decent size blister developed on the left foot. 3/27/21 Symptoms are still the same as the day before

Swelling of throat and neck, shortness of breath, light headed, took antihistamine and monitored for several hours.

Woke up with large headache and nausea, chills and hot flashes. Severe throat pain and fatigue with chills throughout the day, arm pain and lymph node swelling, joint pain

Small itchy red bumps on my arms and legs. Feels like mosquito or spider bites. Lymph node in my neck is swollen and painful.

Caller called stating that he got his vaccine on 04/05/2021 to the left arm and on 04/06/2021 he woke up with swolen lymph nodes to his left arm pitt. He states that they're tender to touch and the swelling is getting worse. He denies any other symptoms.

Extremely lethargic, sore throat, chills, achiness, nausea, dizziness, congestion, runny nose, burning sensation in lungs, coughing, asthma attack, swollen lymph node under arm with injection

I started developing another rash on my right low back, I had pain in my lower back on the right side and superficially on my stomach (right side). More rash formed, also on the right side of my low back and right side of my stomach. Swollen inguinal lymph nodes on right side. Treatment is valtrex.

I felt numbness in my right leg, the numbness went up to my right arm and then I started slurring. This happened within a few minutes. I laid down and called a nurse adviser. I was recommended to go to ER, so my wife took me to ER. They did CT scan of my head, then CT scan of my head and neck with contrast, then MRI of my head, then MRI of my head and neck with contrast. It was confirmed that I had an ACUTE ISCHEMIC STROKE. It was decided to perform carotid endarterectomy surgery to remove a clot in the neck carotid artery. The clot was removed.

Woke up with a small (size of a quarter) on left side of neck/shoulder (about an inch above the center of my clavicle). Lump is movable and only painful if enough pressure is applied. Also feel lump if I move my head to the right (stretch away from lump)

Left side, arm, chest and face felt very swollen and numb. No visible swelling or redness or hives or anything Started about 20 minutes post vaccine and lasted about an hour

Within 24 hours of vaccine, patient had fatigue, swollen cervical lymph nodes, malaise. These symptoms improved but did not resolve by dose #2 and were much worse following dose #2 and are still persisting with minimal improvement in the last 4 weeks.

First dose was uneventful. but second dose was followed by fever and chills on Thursday. These resolved. On Saturday he developed the hives that were diffuse and he came to the ER on Sunday and got prednisone single dose and Benadryl. The rash improved for one day then recurred yesterday and today. He now complains of facial swelling but is breathing and swallowing fine. No other complaints. Has a history of allergy to Nickel.

Patient presented to ED with complaint of left arm pain starting today (2 days post-vaccine). Axillary pain, lymph node palpable. Dx axillary lymphadenopathy. Patient received ketorolac 30mg IM x1 and discharged home from ED.

2 days after my second pfizer dose, I had residual pain in my armpit on the side ingot the shot. While showering I noticed a large swollen lump under my armpit. Nearly 2 weeks later, the lump is still there,though 90% of the pain is gone. The lump has not reduced in size.

Pulmonary embolism of right lung. Required hospitalization x1 overnight. Was started on enoxaparin inpatient, then transitioned to Eliquis 10mg twice daily with intent to drop down to 5mg daily. Presented to ER on 3/3/21 with chest pain. Patient continues to follow up in clinic.

Swelling in left pectoral (chest area). Became red and squishy. Went to Hospital on 04/19/2021 at 12:30 pm into the Emergency Room. Took 5 hours for a nurse or doctor to look and given an uncertain diagnosis. Was prescribed by the doctor Benadryl and Pepcid AC.

Fever, chills, headache, sore arm, swollen arm, lethargy, sensitive and sore skin. These began within 6 hours of the shot and were debilitating for 48 hours. Severe for 49-72 hours and then fever broke and other symptoms gradually subsided over next 48 hours. At some (unknown) time after the vaccine, I developed viral pericarditis. In addition to the above, this manifested in chest pain (no difficulty breathing) which radiated from what felt like the lungs, through my windpipe, into a sore throat, jaw muscles hurting, inner ear and neck soreness. These symptoms lasted after all had subsided and didn?t disappear until 14 days after the 2nd vaccine.

Swollen lymph node in left underarm; Body ache; nausea; lethargy; chills; joint pain; tiredness; headache; This is a spontaneous report from a contactable consumer (Patient). A 31-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 19Apr2021 14:00 (Batch/Lot Number: Unknown) at the age of 31-years-old as single dose for covid-19 immunisation. Medical history included the patient diagnosed with COVID-19 prior to vaccination. The patient's concomitant medications were None, the patient did not receive other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced swollen lymph node in left underarm, body ache, lethargy, chills, joint pain, tiredness, headache, nausea on 20Apr2021 05:00. No treatment received for the events. Since the vaccination, the patient was not been tested for COVID-19. The outcome of the events was recovering. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

PRIOR TO FIRST DOSE I WAS STRONG. I COMPLETED A 240 MILE HIKE IN RECORD TIME. 2 DAYS AFTER FIRST DOSE I EXPERIENCED TROUBLE BREATHING AND FATIGUE. I THOUGHT THIS WAS NORMAL SIDE EFFECT. I COULD NOT WALK AROUND THE BLOCK WITHOUT RUNNING OUT OF BREATH. SYMPTOMS LASTED AN ENTIRE MONTH. AFTER SECOND DOSE, THE VACCINE CLINIC RECOMMENDED I CALL MY DOCTOR. DOCTOR ADVISED I GO TO ER. 2 DAYS LATER, I GO TO ER. I STAY IN ER FOR 3 DAYS WHILE THEY RUN TESTS. I AM DISCHARGED ON 3/9/21. COINCIDENTALLY, THAT WAS WHEN CHEST PAINS STARTED. I HAVE HAD CHEST PAINS EVER SINCE. I HAVE VISITED DOCTORS, AND HAVE TAKEN TESTS, AND HAVE BEEN DIAGNOSED WITH PERICARDITIS. I AM NOW TAKING COLCHICENE WITH IBUPROFIN

I had fever and achiness the day after. Fever of 101 degrees. This was on top of an injection site reaction with pain. 36 hours after the shot I developed extremely swollen lymphnodes in my chest area, accompanied by soreness and pain. Along with this has been continuous (seemingly non-stop, as the issue has not been resolved) muscle spasms.

Vomiting 24 hours later. The next few days intense heartburn followed by a full body rash (small red hive looking bumps) and extremely swollen feet (May 11). Swelling on lip and leg May 15 too.

Patient received vaccine Thursday morning. Later that evening, he started experiencing chills, fever (>101F), and body aches for the next couple of days. Saturday morning, fever continued with body aches throughout the day but other symptoms subsided. Chest pain started Saturday evening but patient was unsure what it was. Saturday after midnight, patient went to sleep and woke up after 30 mins with chest pain, chest pressure, burning sensation in chest, and stiff neck. Patient couldn't lay down in bed and went to ED.

pressure headache; tinnitus; hyperacusis; grainy and double vision; photophobia; facial twitching; Pain in back, shoulders and arms; Pain in back, shoulders and arms; Pain in back, shoulders and arms; Burning sensations in back and arms; Muscle weakness in legs and arms; Large rash at injection site; Swollen lymph nodes in both arms; This is a spontaneous report received from a contactable consumer (patient). A 31-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot number: ER8736, Expiration date: not reported) via an unspecified route of administration in left arm on 23Apr2021 at 10:00 AM (at the age of 31 years) as 2ND DOSE, SINGLE for covid-19 immunisation. The patient medical history included diabetes (controlled) and concomitant medications were not reported. The patient had a history of allergies to Demerol. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EP6955, Expiration date: not reported) via an unspecified route of administration in left arm on 31Mar2021 at 12:00 PM as 1ST DOSE, SINGLE for covid-19 immunisation. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination was reported as Vitamin C, D3. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 26Apr2021 at 07:45 AM, the patient stated that he woke up with pressure headache, tinnitus, hyperacusis, grainy and double vision, photophobia, facial twitching, pain in back, shoulders and arms, burning sensations in back and arms, muscle weakness in legs and arms, large rash at injection site, swollen lymph nodes in both arms. The adverse events resulted in the doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Treatment was received for the adverse events which includes Prednisone. The events were reported as non serious. Outcome of the events were reported as Not recovered.

Lymph node on my collarbone (the left side). skin rash over different parts of my body (right hand +right leg).

Swollen lymph nodes across right side of body. Lymph nodes of shoulder, chest and traps were swollen and body movement was severely restricted due to these swollen lymph nodes. I only got one of the vaccines. Did not get the second one.

Nausea, headache, migraine. Extreme pain and swelling of lymph nodes. Lymph nodes under the armpits swelling with extreme pain. Swelling of lymph nodes was greater and more painful near site of injection.

"Pt w/ hx of Asthma and Anxiety. No current information regarding pt medications available. NKDA at the time of vaccination. Pt presented for 2nd dose on 7/1. Pt noted that after first dose Pfizer, pt had neck tightness and angioedema. Time course unclear. Pt was administered Janssen IM Left Deltoid 206A21A as an alternative to 2nd dose Pfizer. No reaction noted after vaccination on 7/1."

Developed severe vision impairment, tingling sensation in extremities, loss of balance/ coordination, alterations in depth perception, reflexes become unresponsive upon physical exam at doc office & developed severe headache. Was unable to work or function normally for over 2 months being unable to work and needing additional help to care for my dependents. Was diagnosed with GBS by the hosapital.

Two days after vaccine I was having trouble breathing, irregular heart beat, congestion, bloating, swelling. Went to hospital and nothing was found in tests. A month and a half later I was having similar symptoms and went to the hospital where they found I was having heart failure. My heart was preforming 10-15%.

severe cervicle neck pain for 3 weeks including radiculapathy severe headache inter cranial pressure for 2 weeks non stop pressure in head and different parts of the brain due to elevation swollen lymph nodes left side of face correlates to vax in left arm swollen face and neck fluid filled ears and pressure & mastoid bone pressure neasua due to constant feeling of unsteadiness dizziness & vertigo for 7 weeks tingling in each section of brain electrical shock sensations weakness in arms legs hands severe fatigue and malaise lingering severe brain fog peripheral vision blurriness constant tunnel vision spine pain to middle spine after neck pain stopped chest bone pain and tightness heart pressure and pain random joint pain weakness tingling in hands and legs and head stomach discomfort diarrhea for 6 weeks and soft stool ringing in ears occasionally arachnoid cyst found where grinding & neck pain originated radiating into back of head and severe headaches to entire brain or different sections at random

After 2 days receiving the shot - woke up with severe painful swelling in the outer right chest and under armpit area. Swelling continued for multiple days and as of this time is still present but no longer painful.

He got a little bit of tingling in his left arm; headache; Muscle soreness in the arm the vaccine was administered; His thumb looks swollen and inflamed; Muscle weakness; Experiencing swelling in left arm/thumb and numbness from tip of thumb to joint on opposite limb of administration.; Experiencing swelling in left arm/thumb and numbness from tip of thumb to joint on opposite limb of administration.; This is a spontaneous report from a contactable consumer (patient) reported that a 32-year-old male patient receives first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EJ1685 and Expiration Date 31Mar2021) intramuscularly on 22Dec2020 15:00 at single dose for Vaccination (covid-19 immunization). The patient's medical history and concomitant medications was reported as none. The patient experienced swelling in left arm/thumb and numbness from tip of thumb to joint on opposite limb of administration. Since Wednesday, 23Dec2020, he has been experiencing some numbness in the arm opposite of where the vaccine was administered. He clarifies the vaccine was administered in the deltoid of his right arm, and the numbness he is experiencing is in his left hand. His thumb has been partially numb since last Wednesday. He got a little bit of tingling in his left arm since last Wednesday (23Dec2020).The patient explains on Tuesday, 22Dec2020, when he was administered the vaccine he only had typical side effects that went away within 24 hours. He experienced headache and muscle soreness in the arm the vaccine was administered. Both of these symptoms went away and he has recovered completely. After 24-36 hours, he noticed numbness on hand opposite of the arm where the vaccine was administered. His thumb has been partially numb which has lasted about 6 days. He clarifies the numbness is on the palm side- which he was told was not related to the nerve. His thumb looks swollen and inflamed compared to the other. He also has noticed muscle weakness in the opposite arm. The patient states he can't recall if the numbness occurred within 24 hours but he knows by 24 hours, he did have the numbness. His thumb is partially numb on the side of the palm and up to the middle of his thumb where the joint is.Patient states yesterday the numbness was noticeably worse when he was sleeping. However, today the numbness seems to be back where it was before. He forgets about the numbness since he is not actively doing anything with that particular hand, but he doesn't forget about it completely. The numbness hasn't improved any, it's been consistently there and never went away. While reading off of his card, the patient cannot determine if the Lot number is an F or an E because the number is underlined. He thinks it might be an E. Patient was able to confirm the Lot number begins with an E after looking at the information sheet he was provided. He also sees the product number, CVX 208. Patient states he has no allergic reactions and nothing that he knows of that is an underlying condition. Patient states he hasn't had any testing done in regards to these events. He wanted to talk to the manufacturer and report it to the (Contact center name) first before he schedules something at Urgent Care. He wanted to check and see if what he is experiencing is a lesser known symptom. He couldn't find this information anywhere. The outcome of events, headache and muscle soreness was recovered on 23Dec2020. The outcome of Numbness in hand was not recovered. The outcome of other events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

-Swollen left supraclavicular lymph nodes (1 medium and 1 large that are hard like marbles) -Entire left supraclavicular fossa region is swollen around hardened lymph nodes

Anaphylaxis Please note previous VAERS report of Bell's Palsy 8 days following the first dose and subsequently treated with prednisone and valacyclovir. This neurologic diagnosis was not reported by the patient during the consent process with the COVID19 vaccination center staff. Confirmed following review of the consent form. Documentation from Emergency Department Provider: Patient is serially reassessed following treatment for anaphylaxis. Patient has significant improvement in diffuse erythema and hives within 20 minutes. He has gradual improvement in his sensation of throat swelling. He is observed while in the emergency department serially over 4 hours with no recurrence of symptoms. He does not require any repeat dose of epinephrine and feels at baseline. Discussed my suspicions that patient may have had a reaction to COVID-19 vaccine as he has had no other new medications or exposures that he is aware of. As he will not be receiving another vaccine there is nothing to necessarily stay away from. Make sure he notifies individuals about this for any new vaccine should he receive them. Patient is observed for sufficient time but discussed possibility for biphasic reaction. Recommend he return should he have recurrence of symptoms. Recommend he take EpiPen as prescribed for any throat swelling or progressive shortness of breath. Recommend follow-up with a primary care provider for this visit..

suspected COVID-19; suspected COVID-19; Fatigue; Body aches; Headache; chills; The initial case was missing the following minimum criteria: no adverse event. Upon receipt of follow-up information on 04Jan2021, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable healthcare professional, the patient, from a Pfizer sponsored program IBCC (Inbound Call Center for HCPs). A 32-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EK5730), intramuscular in the left deltoid on 15Dec2020 at 21:00 (at the age of 32-years-old) as a single dose for COVID-19 immunization. Medical history included ongoing hypertension from 2009 and COVID-19 from 10Jun2020 to an unknown date in 2020. Ongoing concomitant medications included fosinopril (MANUFACTURER UNKNOWN) taken for hypertension from 2017. The patient did not receive any other vaccines on the same day as the BNT162B2 vaccine. On 19Dec2020, shy of about 96 hours of getting the vaccine, the patient experienced fatigue, body aches, headache and chills. He did not have any fever. The patient stated that he recovered from the fatigue, body aches, headache and chills by 19Dec2020. The patient was fine from 19Dec2020 until 01Jan2021. On 28Dec2020, the patient had a COVID-19 PCR test that came back negative. On 01Jan2021, the patient suspected that he had COVID-19. He had a fever of 103.1 degrees Fahrenheit, body aches, chills like he was freezing to death, fatigue, diarrhea; however, he did not have nausea or loss of taste or smell. He had swollen lymph nodes, but no sore throat and his oxygen saturation was okay in Jan2021. He was also having chest pain but it was more like intercoastal pain. He stated that these current symptoms were significantly worse than the ones he had just after getting the vaccine and felt more like the symptoms he had when he had COVID-19 before on 10Jun2020 (positive IgG for COVID-19-tested in 2020). The patient had a COVID nasal swab (PCR) done at an urgent care (physician's office) on 02Jan2020 or 03Jan2020 and was awaiting the results. The clinical outcome of the suspected COVID-19 was not recovered.; Sender's Comments: A causal association between reported suspected COVID-19 cannot be excluded.

12 hour post-vaccination- shivering and body aches 20 hours post-vaccination- angioedema/tongue swelling

102 fever for a day and a half. Chills, aches, headache, lightheaded, stuffy nose, swollen lymph nodes right armpit

Chills; fever; muscle soreness; headaches; swollen lymphnodes; This is a spontaneous report from a contactable healthcare professional. A 32-years-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), Lot number EV5730, intramuscular in right arm on 17Dec2020, at 12:00 PM (at the age of 32 years old) as a single dose for COVID-19 immunization and the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: EL 3246, intramuscular in right arm, on 07Jan2021 at 11:00 (at the age of 32 years-old) as a single dose for COVID-19 immunization. The vaccinations were administered at a hospital. Medical history included an allergy to sulfa drugs. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. It was not known if the patient receives any other vaccines within 4 weeks prior to the COVID vaccine. The patient received unspecified medications within 2 weeks (date not reported) of the vaccination. On 08Jan2021 at 00:00, the patient experienced chills, fever, muscle soreness, headaches, and swollen lymph-nodes. The patient was not hospitalized for the events nor received treatment. The clinical outcome of the events of Chills, fever, muscle soreness, headaches, and swollen lymph-nodes was recovering. Since the vaccination, the patient had not been tested for COVID-19.

14th Jan-lump left-groin-lymph node, he feels it, body aches, 15th Jan-feeling better-slept-all day 16th Jan-lay in bed 15 & 16th Jan till noon-holiday week-end 17th Jan-lay in bed 18th Jan-lay in bed 19th Jan- lump in left neck-lymph node he says-enlarged-he feels it-hoarse like sound in his voice 20th today-Jan-better today-feels like he is getting to FLU-nose runny

Visibly swollen lymph nodes in underarm on the left, left side of neck (near the base) and under chin (on the left)

Large nodule on left side of neck; Lymphadenopathy; Some pain occurs when straining neck, but mostly just very uncomfortable; Some pain occurs when straining neck, but mostly just very uncomfortable; Some pain occurs when straining neck, but mostly just very uncomfortable; This is a spontaneous report from a contactable pharmacist (patient). A 32-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in the left arm, on 15Jan2021 at 13:00 (at the age of 32-years-old) at a single dose for COVID-19 immunization. Medical history included penicillin allergy and sulfa allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications, taken within two weeks of vaccination, included ibuprofen (MANUFACTURER UNKNOWN). The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on an unspecified date for COVID-19 immunization. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced large nodule on left side of neck, lymphadenopathy, and some pain occurs when straining neck, but mostly just very uncomfortable on 16Jan2021. The clinical course was reported as: The patient woke up the morning after being vaccinated and had a large nodule on left side of neck, which appeared to be lymphadenopathy. There was some pain that occurred when straining neck, but patient was mostly just very uncomfortable. The patient did not receive any treatment for the events. The clinical outcome of large nodule on left side of neck, lymphadenopathy, and some pain occurs when straining neck, but mostly just very uncomfortable was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19. The batch/lot number for the vaccine, BNT162B2, was not provided and has been requested during follow up.

Pt is a 33 y/o male who presents to the ED with c/o of left le swelling progressing over the last 4 days. Pt has no other c/o. Denies fever, cough, cp, abd pain, n/v/d. Pt has had his first COVID vaccine 1/30. Patient was noted to be tachycardic to the 120's in the ER, after 1L of normal saline still tachycardic to the 110's. Lower extremity doppler was negative for DVT, however PE protocol CTA of the chest was positive for a PE, report follows. Patient was given lovenox and flown to Medical Center for higher level of care.

Swollen lymph nodes; Developed Shingles on his face; This is a spontaneous report from a contactable other healthcare professional. This other healthcare professional reported for a 32-year-old male patient (her fiance). A 32-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration at the right arm on 29Jan2021 at single dose for COVID-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The patient previously took the first dose of bnt162b2 on 08Jan2021 for COVID-19 immunization. The patient developed shingles on his face on 31Jan2021 and swollen lymph nodes on 01Feb2021. The events were reported as serious (medically significant) and worsened. There were no investigation assessment. The patient had not recovered from the events at the time of the report. Information on the batch number has been requested.; Sender's Comments: Based on the compatible temporal association and the drug's known safety profile, the Company considers the event swollen lymph nodes is possibly related to suspect vaccine BNT162B2. Other than a temporal association, there is no evidence or argument to suggest a causal relationship between BNT162B2 and the event shingles, which is likely an intercurrent 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.

Pfizer-BioNTech COVID-19 Vaccine EUA: after seoncd dose of vaccine patient reported fatigue then axillary lymph nodes swelled to the size of a golf ball. Affected area uncomfortable but no erythema. At clinic visit one week after vaccination patient states symptoms improving and no new symptoms developed. Patient discahrged to home from clinic stable.

Fever peaking at 102 and persisting for around 72 hours, chills, sweating, severe fatigue, severe tightness/aching through neck and shoulders, significant swelling/tenderness in left armpit.

Had swelling to the right side of the neck lasting x ~6 hrs most likely the result of a swollen right lymph node.; This is a spontaneous report from a contactable Other HCP (patient). A 32-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number EL3248, on 12Jan2021 20:30 at single dose in left arm for COVID-19 immunization. Medical history included Known allergies to Pumpkin seeds and Codine. Concomitant medication was none. The patient previously received first dose of BNT162B2 (Lot number EH9899) on 22Dec2020 19:30 in left arm. The patient had no other vaccine in four weeks. covid tested post vaccination. The patient had swelling to the right side of the neck lasting x ~6 hrs most likely the result of a swollen right lymph node on 14Jan2021 21:00. No treatment was received for the event. The outcome of the event was resolved on 15Jan2021.

Pfizer-BioNTech COVID-19 Vaccine EUA: patient presents to ED one day after second dose of vaccine reporting polydipsia, polyuria, nausea, vomiting, and myalgias but no abdominal pain. Vitals within normal ranges except blood pressure 127/100 mmHg and pulse 110 beats per minute. Administered antiemetics, analgesics, intravenous fluids, antidiabetic medications and discharged to home in late afternoon. When additional triglyceride results became available patient contacted to go to ED for nausea and other symptoms in setting of elevated triglycerides. Shortly after midnight the next day patient presented to ED nauseated and fatigued. Vitals within normal ranges except for blood pressure 162/96 and pulse 107 beats per minute. Patient admitted with diagnoses of mild DKA and mild pancreatitis. Administered antidiabetic medications, intravenous fluids, antiemetics and discharged the next day with improvement in symptoms and laboratory values.

1-2 days later swelling of lymph node on back of neck. I?ve never to my knowledge had swelling in this specific lymph node area.

Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Hypotension-Medium, Systemic: Seizure-Severe, Additional Details: Approx. 15 minutes after getting his COVID vaccine pt. notifed clinic staff that he was feeling unwell and his heartbeat was irregular. Pt. then started to collapse and after being assisted to the ground had a seizure lasting approx. 10 seconds. After waking back up from seizure pt. had trouble breathing. Clinic staff notified me and I immediately administered 0.3 mg of epinephrine via an auto-injector. 911 was called and Pt. was able to sit back up while he waited for EMS.

About two weeks after first shot, I got shingles. It could be unrelated, but since I'm young, perfectly healthy, not abnormally stressed, and haven't ever had singles before, I thought there might be a chance it is related. I've seen online other young people who are saying that they got shingles after the first shot of Moderna or Pfizer. Maybe it was just a coincidence, but I figured it was worth reporting. It is overall a pretty mild case because I got on the antiviral drugs pretty quickly. Wondering if I should still get my second shot on schedule or wait until my shingles is all cleared. I have asked my doctor and am awaiting a response. I first noticed the symptoms on Saturday (3/20) exactly two weeks after my first shot.

Metal taste in mouth, severely swollen lymph nodes in L armpit, nausea, and severe testicular pain/sensitivity. Unable to walk or sit without discomfort. Events lasted 2 days.

Auxiliary lymphadenopathy on the left side of the body from March 24 to approximately March 29. Discomfort due to left auxiliary lymphadenopathy in armpit and a visible egg shaped swelling. Mild flu like symptoms of chills and joint aches occasionally from March 25 to March 26.

Swelling in the left axilla region, tender to touch. Started approximately 24 hours after 2nd injection, ongoing at the time of this report.

Approximately 9 days after injection in left arm, started experiencing symptoms in right armpit consistent with swollen lymph nodes including: intermittent sharp stinging pain similar to ingrown hair or inflamed hair follicle, as well redness and dull pain upon palpation. Over several days, swelling has increased significantly and pain has increased a little as well. Today, 14 days after injection in left arm, starting to experience onset of lymph node swelling in left armpit as well. Additionally, starting 9 days after injection, concomitant with lymph node swelling, I believe I have felt slightly fatigued and have felt 1 degree warmer than usual, though not actually feverish. I confirmed a temperature of 98.9F today around 5:45PM, whereas my normal temperature is about 97.7F when measured by the same method.

pt says his neck was itching and had swelling and bumps on his neck. His body was itching and it would swell and turned red everywhere he would scratch. he took an antihistamine with helped. He woke up next day and all symptoms were gone with the exception on swelling and redness in the neck which he has a spot the size of a golf ball. Pt is still taking the antihistamine. Pt will contact PCP if symptoms do not subside.

Developed a medium size knot where shot was given that was hard and sore to the touch. Then also developed the same thing up on my collar bone area (may be a lymph node) that is more sensitive to the touch than my arm. Makes me arm feel somewhat numb and harder to grip at times.

Patient developed Guilain Barre Syndrome GBS as confirmed by hospital neurologist. Dr felt the Covid 19 vaccination was the likely cause.

Patient returned from outside at about 40 minutes after injection. Symptoms included rash development on face and trunk, swelling of face and lips and slight shortness of breath. One adult epipen was administered and EMS was called (9:15 am). Fire Dept arrived approximately 10 minutes later and EMS followed. Symptoms were subsiding and pt refused transit with EMS. Patient received ride with parent to ER

Swelling in the neck started a few days after receiving the first dose of the Covid vaccine. Its not known if the swelling is related to the vaccine. Medical exam by primary said my thyroid is a bit full. Some post nasal drip as well. Discomfort from the swelling became gradually more significant over several days. Some tightness when swallowing food. At this time of year I typically get allergy symptoms of hay fever (sneezing, itch/watery eyes, etc.) but neck swelling has never been a symptom for me. Started taking Claritin once a day as I usually do this time of year as well.

Caller stated that she received his first vaccine on 4/13/2021 and on 4/13/2021 member's started having pain to his armpit with tenderness to his lymph nodes. He denies having other symptoms.

Supraclavicular lymphadenopathy noticed; Generalized blanching rash covering thighs abdomen chest and arms,around 24 hours after the second dose resolved within a day; This is a spontaneous report from a contactable Physician (patient) A 32-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot No: unknown, expiration date: unknown) via an unspecified route of administration anatomical location Left arm on 13-FEB-2021 12:45 at single dose for COVID-19 immunization. Patient historic vaccine include first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot No: unknown, expiration date: unknown) via an unspecified route of administration anatomical location Left arm on 23Jan2021,10:30 at single dose for COVID-19 immunization. medical history included Autoimmune urticaria. concomitant medication include Antihistamine. On 14Feb2021 13:00 patient experienced Generalized blanching rash coveringthighs abdomen chest and arms, around 24 hours after the second dose resolved within a day.Supraclavicular lymohadenopathy noticed 72 hours after. patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any treatment for the event. Prior and post to the vaccination, the patient was not diagnosed with COVID-19. patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any treatment for the event. Prior and post to the vaccination, the patient was not diagnosed with COVID-19.The outcome of event was Recovering/Resolving. Information on the lot/batch number has been requested

Once I received the dose my elbow began to hurt. The feeling later continued to my left hand. The elbow pain now feels of burning and stiff. My left hand has swelled and feeling of joint pain. My left hand also is cold to touch. No discoloration.

My husband had an anaphylactic reaction within 30 minutes of receiving the Pfizer vaccine. EMS was called and he was taken by ambulance to the hospital. He was having trouble breathing, felt pressure in his chest, was light headed, started having severe chills and heart rate was elevated above 100 beats per minute. Benadryl was given on the way to the hospital and once at the hospital they gave him Tylenol, Pepcid, toradol and solu-medrol.

Fainting; Swelling of arms and hands; Feeling hot; Hives on the face and limbs; Shortness of breath; This is a spontaneous report from a contactable consumer (patient). A 32-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (at 32 years of age), dose 1 via an unspecified route of administration, administered in arm left on 31Mar2021 14:30 (Batch/Lot Number: EW0150) as a single dose for COVID-19 immunisation. Medical history was None. The patient's concomitant medications were not reported. The patient did not receive any other vaccine within 4 weeks prior to the covid vaccine. He was not diagnosed with Covid-19 prior to vaccination. He has not been tested for covid since the vaccination. He had no allergies to medications, food, or other products. The patient experienced swelling of arms and hands, feeling hot, hives on the face and limbs. He also had shortness of breath and fainting. The events started on 31Mar2021 18:45 with outcome of recovered with sequelae. Therapeutic measures were taken as a result of the events as the patient was administered with IV saline, steroids and antihistamine. The events resulted to Emergency room/department or urgent care. Information on the lot/batch number has been requested.

Fever, chills with uncontrollable shaking, whole body muscle fatigue and soreness, swollen lymph node with extreme pain. On 4/16/21 the pain from my left armpit lymph node almost made me vomit. Swelling has persisted through today 4/20/21. Chills started on 4/15/21 and ended 4/18/21. Fever from 4/15/21 to 4/17/21. Treated with bedrest and ice pack / warm compress.

Mild fever/chills for approximately 10 hours from the initial time of reaction, body aches for approximately 18 hours from time of reaction, lymphoma in the left armpit with noticable swelling and tenderness starting at about 4 hours from initial time of reaction and continuing on to current time, approximately 54 hours from time of vaccination.

fear of death/doom; I went into a full Anaphylaxis shock; This is a spontaneous report from a contactable consumer (patient). A 32-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot Number: EW0150) via an unspecified route of administration, administered in Arm Left, at the age of 32-year-old, on 06Apr2021 09:45, as SINGLE DOSE for covid-19 immunisation. Medical history included allergy to shrimp. The patient was not diagnosed with COVID nor was he tested post vaccine. The patient's concomitant medications were not reported. On 06Apr2021 at 10:00 am, 15 mins after the vaccine, a large hive appeared on his forehead and then 1.5 hours later the patient went into a full Anaphylaxis shock with difficulty breathing, throat closing up, fear of death/doom, tingling sensation in whole body, heart pounding rapidly, chest pain, dizziness. The patient went to the emergency room/ urgent care and was hospitalized for 1 day. Therapeutic measures taken in response to the events included administration of Steroids, antihistamines, and pain killers. Outcome was recovering at the time of the report.

Sporadic bumps showing up all over my body, one on the bottom of my foot. Most were very itchy. Seemed to flare up when fatigued or during sleep. They would be red and raised, almost like a small mosquito bite. Then they would dissipate, although some would leave a tiny red dot. Almost seemed that there was a bug in my clothing, so I showered, changed my clothes, and searched thoroughly in bed, closet, clothes for, bugs but there were none. My wife also did not get any of these itchy bumps in spite of sharing a bed. It may be worth noting that my wife got shingles 10 days after receiving the 1st Pfizer dose.

while the lymph node swollen was declare i also feel some chest pain during the day since the day following the vaccination. it may be due to the swollen lymph node because the injection was on left arm hence the swollen is my left armpit but i have been feeling pressure in my chest and lot of pain coming from the swollen armpit.

A 32 male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 2 via an unspecified route of administration, administered in Arm Left on 19Apr2021 14:30 (Lot Number: EW0170) as single dose for covid-19 immunization. Facility where the most recent COVID-19 vaccine was administered was Other. The patient medical history was not reported. Concomitant medications included amoxicillin, daily multivitamin, probiotic supplement. The patient previously received the first dose at arm left on 30Mar2021 14:00 as single dose for covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced swelling, reddened skin, and itchiness at vaccination site, low- grade fever for 36 hours, slight cough, headaches, extreme tiredness, brain fog from 19Apr2021 19:00. No treatment received for the adverse events. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. Outcome of the events was reported as recovering. No follow-up attempts are needed. No further information is expected.

Arm pain for 2 days on a 7 of 10 pain scale. Swollen lymph nodes under the arm where vaccine was administer

- Fever, chills / sweating, headache, fatigue, body ache lasting approximately 24 hours in total from onset. Significant symptoms at ~16 hours post-vaccine - Significant lymph node swelling on left side of body (side of vaccine administration) - under left arm, groin, neck in particular are noticeably enlarged and tender to the touch. At 96 hours post-vaccine, small pain still noticeable in enlarged lymph node locations (left groin, under left arm, neck). It does seem to be somewhat improved day over day (as of this writing, 100 hours post-vaccine) - Chest tightness from approximately 24 hours post vaccine continuing to this writing (100 hours post-vaccine), though unclear if related to mild pain of left underarm lymph swelling or seperate

33 year old healthy man presented with seizure to Hospital ER on 5/7/2021. He required intubation. CT scan and MRI of brain showed dural venous sinus thrombosis along the anterior to mid aspects of the sagittal sinus. CBC was normal at presentation with WBC 13.9, HGB 16.1 and PLT 367k. He was admitted on unfractionated heparin. Repeat platelet count on 5/8/2021 was 153k. HIPA was negative. Patient was extubated and continued to improve. He was put on warfarin and sent home. He has some mild personality change in the immediate weeks of discharge. Hypercoagulable workup had normal Prot S & C activity, normal ATIII activity. The Factor V Leiden and Prothrombin Gene were negative. The homocysteine level was elevated at 16.3.

Patient called to office 6/8/2021 and complained of swollen neck, a "weird fuzzy feeling in his face and head", and sweats. Per the patient he has been having this feeling since his COVID vaccine 3/2021. Patient told nurse he has been having sweats and arm pain, and heart keeps racing. Patient stated that is cardiologist has said that everything is fine. Patient stated he has also been to the ER and they could not find anything with the tests that were done. He has been to healthcare facility several times. Per information patient received the Pfizer vaccine on 3/13/21.

Patient developed infraclavicular lymphadenopathy in two lymph nodes on the left side after the left arm injection of COVID-19 vaccine one week after the injection. This was followed with ultrasound to confirm morphologically normal enlarged (reactive) lymph nodes, and resolved within 1 month of symptom onset. No ongoing concerns.

Cardiomyopathy Severe Sepsis CHEST X-RAY MEASURE OF CARDIAC SAMPL & PRESSURE, L HEART, PERC APPROACH FLUOROSCOPY OF LEFT HEART USING LOW OSMOLAR CONTRAST FLUOROSCOPY OF MULT COR ART USING L OSM CONTRAST

Dose 1: Zero side effects Dose 2: Fatigue within four hours, migraine headaches to follow periodically for three days, Pain in left shoulder and swelling and redness, Swollen Lymph Node under the armpit, pain followed in shoulder and arm for one week

I received the first covid vaccination in May 5th and a week or so later started getting tingling in my toes that would come and go. I did not tie it to the vaccine at first as it was not a listed side effect I saw. On 5/26/2021 I received the second shot and the tingling spread to more of my toes, and then into my hands a few days later. After another few days my legs became very weak and I went into the Emergency Room where they diagnosed me with Guillain-Barre and my symptoms continued to worsen where I lost all my reflexes and ability to walk as usual

Patient was seen by primary care physician and opthamologist. Patient was diagnosed with shingles (also ocular shingles). Patient reported a rash from top of head to eye, and from nose to ear on the right side of the body. He experienced swollen lymph nodes on the right side and eye swelling. He lost half of his vision in the right eye that has still not returned at this time. In addition to the shingles, he experienced an excrutiating mgiraine (10/10 on pain scale) which he described as the worst he has ever experienced. He also expreinced joint pain and fatigue. At this time, he is being treated with a course of valacyclovir.

Severe pain in knuckle joint which causes swelling and pain in index finger on right hand. The pain is still ongoing, been almost 4 weeks. Not getting better even with ibuprofen. Loss of strength and mobility in finger, hard to use pencil or chopsticks. Never had injury there before, only happened after second dose of vaccine.

After 10 minutes, clammy hands which lasted for 10-15 minutes. After 4-5 hours, sore arm on injection site. Soreness persisted and relieved for 3 days. After 5 days, louder than previously experience in right ear along with pressure inside of right ear. Persisted for a few hours, hard to sleep. Then relieved. After 5 days, scratchy throat, even swallowing caused gag reflex. Persisted for a few hours, hard to sleep. Then relieved. After 6 days, right arm lymph node swollen to a little over a half centimeter. Saw doctor and got blood test for white blood cell count. Has not relieved yet. Please contact me at a later date to understand how long it lasted.

his body seems to be swollen; patient also thinks that he had corona and has been suffering from the side effects of corona specifically; This is a spontaneous report from a contactable consumer (patient) A 32-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Lot number: ER8733 and Expiration date: unknown) via an unspecified route of administration, administered on the right arm on 31Mar2021 (at the age of 32 years old) as dose 1, single for COVID-19 immunisation. The patient has no medical history and concomitant medications. There was no investigation assessment. On an unspecified date in 2021, patient reported that his body seems to be swollen after receiving his 1st shot yesterday (clarified as 31Mar2021) and was asking if it was normal. The patient also thinks that he had corona and has been suffering from the side effects of corona specifically but he was not taking any medication. The patient did not receive any treatment for the events. The outcome of the reported events was unknown. No follow-up attempts are possible. No further information is expected.

Swollen lymph nodes; tender lymph nodes; This is a spontaneous report from a non-contactable consumer, the patient. A 32-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE;Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 30Mar2021 at 15:30 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma. The patient had no known allergies. Concomitant medications included nicotine (MANUFACTURER UNKNOWN) and (salbutamol) ALBUTEROL. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Apr2021 at 00:00 hours, the patient experienced swollen and tender lymph nodes. Therapeutic measures and treatments were not taken as the result of adverse events. The adverse event did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events swollen and tender lymph nodes was not resolved at the time of this report. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Unilateral swollen lymph nodes in the left armpit. Left armpit visibility swollen compare to the right side. Tender and painful to the touch.

diagnosed with GBS/ Symptoms started with tinglyness in hands and feet and proceeded to the point of hospitalization /in ability to walk, sit up un aided and affected involuntary functions.; This is a spontaneous report from a contactable consumer (patient). A 32-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left at age of 32 years on 29Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included diagnosed with COVID-19 prior vaccination. Since the vaccination, the patient has not been tested for COVID-19. No known allergies. No other medical history. The patient's concomitant medications were none. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Not any other medications the patient received within 2 weeks of vaccination. The patient was diagnosed with Guillain-Barre syndrome (GBS) within two weeks of receiving the first dose. Symptoms started with tinglyness in hands and feet and proceeded to the point of hospitalization that included in ability to walk, sit up un aided and affected involuntary functions. Still unable to function as he did prior to 29Mar2021. Adverse event started since 02Apr2021. The adverse event result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care and Hospitalization, life threatening illness (immediate risk of death from the event), disability or permanent damage. The patient hospitalized for 6 days. Treatment received for the adverse event included (2) Rounds of IVIG. The outcome of the events was not recovered. Information on the lot/batch number has been requested.

About 24 hours after receiving the vaccine I woke up with a fever, headache, bodyaches and fatigue. Symptoms resolved with Tylenol. The next day symptoms continued along with lymph node pain in the right armpit. All symptoms resolved by day 3 post injection. Also note, I was symptomatic and tested positive in August with all of the previously stated symptoms except for lymph node pain. Symptoms post vaccine were much more mild than the actual infection with covid.

Left supraclavicular and left anterior cervical lymphadenopathy mildly tender and mobile. Started 6 days after vaccine to the left deltoid and persisting

enlarged lump under left arm after receiving COVID 19 vaccine # 2 on 1/19/2021 to left deltoid. Got initial does to the left deltoid and tolerated it well. Mild arm soreness. The day he received his 2nd dose he again had arm soreness. On 1/21 he noticed a firm tender lump under the left arm. He denies any fever/chills, redness or swelling to the area. No hx of vaccine reactions in the past

About 10 minutes after getting the vaccine I felt my neck starting to swell or get tight, it wasn't my throat it was on the outside (lymph nodes) I also got very lightheaded. I've had that same feeling swollen lymph nodes on both sides of my neck and being lightheaded ever since. Today (1/24) I started having waves of shortness of breath.

slight concentration issues; mild swelling similar to a histamine reaction; mild swelling similar to a histamine reaction; muscle tenderness; This is a spontaneous report from a contactable consumer (patient). A 33-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot/batch number and expiration date not provided), via an unspecified route of administration on 16Jan2021 11:00 at single dose in left arm for COVID-19 immunization. Medical history included mild allergies to pollens, insomnia, ongoing hypertension from years ago. Concomitant medications in two weeks included mirtazapine, ibuprofen. Facility type vaccine was Workplace clinic. No other vaccine in four weeks. On 18Jan2021 13:00, the patient experienced mild hypertension like symptoms, mild swelling similar to a histamine reaction, muscle tenderness, and slight concentration issues. No treatment received for the events. No COVID prior vaccination. No COVID tested post vaccination. The outcome of the events was recovering. Information about batch/lot number has been requested.

At 09pm experienced a severe fever. (the type i experienced with Sepsis) No other symptoms. It was a debilitating fever with chills and severe shaking. I took acetaminophen with some crackers and plenty of water at 10pm. Fever broke by 01am. I followed with a more water and ibuprofen and fell asleep around 02am. Following morning, I feel pretty good, slightly tired but other wise normal. I have had no gastrointestinal or noticeable issues before or following. The episode was near the point of going to ER. It was something utterly unexpected and I've never experienced a fever with no cause.

Swollen lymph nodes/lymph nodes are swollen on both sides; pain; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: EK9231), via an unspecified route of administration in the left arm on 27Jan2021 at 10:10 (at the age of 33-years-old) as a single dose for COVID-19 immunization. Medical history and concomitant medications were reported as none. On 28Jan2021 at 07:00, the patient experienced swollen lymph nodes. The patient stated that the lymph nodes were swollen on both sides (or so he thought, as he couldn't see the uvula at all). The patient stated, "it looks about the same right now", but the pain (onset: Jan2021) has decreased. The patient stated he had taken several COVID-19 tests prior to the vaccination, on unspecified dates, all negative. The last test, a nasal swab was on Jan2021 with negative results. The clinical outcome of "swollen lymph nodes/lymph nodes are swollen on both sides" and pain was resolving.

Patient experiencing swelling in palm of hands, patient report being tired. Initial V/S bp 140/80, HR 78, o2 sat 97% room air. Patient was observed for further evaluation, at 4:00 patient felt better and no complaints. Latest V/S is 110/70, o2 sat 97 on room air, P-79. Patient was able to grip on both hands. Health education provided and instructed to call his PCP for further evaluation. Patient left the premises with wife.

Injection site soreness; enlarged, painful lymph nodes in left arm pit; enlarged, painful lymph nodes in left arm pit; This is a spontaneous report from a contactable consumer (patient). A 33-year-old male patient received second dose BNT162B2 (Pfizer BioNTech Covid 19 vaccine, lot number EM9810), via an unspecified route of administration at Arm Left on 04Feb2021 17:00 at the 33 years old at single dose for COVID-19 immunization. The medical history was none. The Known allergies was None. The concomitant medication was hydrochlorothiazide, lisinopril (LISINOPRIL/HCTZ). The Historical Vaccine was first dose BNT162B2(lot number EL3249) on 15Jan2021 07:00 at 33-year-old at Left arm for COVID-19 immunization. The patient experienced Injection site soreness and enlarged, painful lymph nodes in left arm pit on 06Feb2021 05:00. The event Injection site soreness was resolving after 36 hours. There was no other vaccine in four weeks. There was not treatment received for all the events. The patient had no Covid prior vaccination. There was no Covid tested post vaccination. The outcome of the event Injection site soreness was recovering, the other events was unknown.

I started having radicular tingling with neck flexion that ran down my left leg starting at the beginning of February. I noted it to a colleague and asked if anyone else who had received the vaccine at the same time as me had any similar effects. I was the only person noted. Slowly the tingling increased and began radiating the entire length of the left leg. It only last for a few seconds at the beginning of flexion then completely resolved. I did not think much of this at the time and figured that it would resolve. On February 27, I began having visual disturbances and symptoms similar to vertigo with a severe nystagmus with a gaze the the right. I attempted a round of azithromycin at this time thinking that there may be an ear infection and that was causing my visual/vertigo like symptoms. There was no improvement with this course of treatment and the visual issues were becoming more of a regular issue. It became hard for me to focus anytime that I would look to my right but was able to focus my eyes while looking forward and the the left. At this time, I opted to have a brain MRI done which was completed on Match 9th as well as having basic labs run. I ended up with an elevated white count on my labs with a left shift. My MRI was read the same day showing a demyelinating process. Multiple neurologist were consulted on this and they believe that my symptoms are not related to MS as the radiologist listed as his top three on his differential but rather what they called post-covid vaccine syndrome, similar to what they are seeing with patients who actually had COVID. I have no medical history, I am not taking any medications and had no symptoms prior to the vaccine. My symptoms were acutely brought on unlike MS and I do not have any of the four most common male characteristics of MS. I do not currently have any muscle weakness, I am not fatigued, it has not progressed to my upper extremities, it does not have a stalking glove approach but rather shoots down, I have no sexual dysfunction. I have been started on a high dose prednisone taper as recommended by the neurologist. My biggest concern is that when I looked for information as a medical provider, I was unable to find anything related to neurological issues and the vaccine. Once, I was placed in contact with multiple neurologist, I was told that they are seen quite a few neurological adverse events.

Patient complained of feeling hot and mild shortness of breath @14:03. Pulse ox 98% on RAD pulse 99-102bpm. Lungs clear to auscultate, he said his breathing got better but started feeling dizzy & swelling. Sent to ER

Roughly three hours after the vaccination, my arm started hurting. There was minor swelling. The swelling has gone away, but the pain persists. The evening of the vaccination, I experienced severe fatigue and tiredness. I slept 14 hours that night and after waking up, I'm tired and lethargic and my arm still hurts. I missed work today (Wednesday 3/24/21) due to the pain and fatigue.

Overnight after receiving my 2nd dose of the Pfizer COVID-19 vaccine, I experienced significant swelling, tenderness, and pain in the lymph nodes under my left armpit at the injection site, extending through the left side of my chest and side (ribcage). The swelling reduced in size and pain over the span of about 10 days, but there is still noticeable swelling and discomfort in the lymph nodes around my left armpit now longer than 6 weeks from the time of the injection.

Pfizer-BioNTech COVID-19 Vaccine EUA Low grade fever and chills first night Body aches first day Lymph node soreness under left arm (injection arm) second day. No fever, no body aches second day.

Severe swelling; tenderness and soreness under the left armpit; Severe soreness at injection site (outer left arm); Severe soreness; fatigue; This is a spontaneous report from a contactable consumer (patient). A 33-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 18Feb2021 1:15 pm (Batch/Lot Number: EL0982) as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications included Nature's Way Alive Max3 Daily multivitamin. The patient had previously received first dose of bnt162b2 (BNT162B2) on 29-JAN-2021 at 1:15 pm (Lot number: EL3246) for covid-19 immunisation. On 19Feb2021 at 12:00 pm the patient experienced severe swelling, tenderness and soreness under the left armpit, severe soreness and fatigue .The treatment for events was unknown. The action taken in response to the event(s) for bnt162b2 was not applicable. Outcome of events was unknown.

1 Day after vaccination the injection site was sore. Later that night the rest of the body became sore. 4 days after vaccination the sore injection site stopped, but a headache began at night. 5 days after vaccination I got fever, chills, swollen lymph nodes, red throat, coughing, pain swallowing, and sore muscles. 6 days after vaccination fever was gone, but the rest of the symptoms remain.

5 MINUTES POST INJECTION : TONGUE STARTS TINGLING . SWEELING GLANDS IN THROAT . TOOK DIPHENYDRAMINE 10MINUTES LATER : BP 143/90 - THROAT STILL SWOLLEN - ARM TINGLING MBUT TONGUE IS BETTER

Woke up two days removed from second shot and I had a swollen lymph node on my left armpit, which was the same side I received the second Pfizer shot, left arm.

3 days after receiving shot started feeling pain in left arm pit near lymph node. Over the coming days pain spread to left side of chest. 4/22 rash started in arm pit and moved to chest. 4/26 went to urgent care and was diagnosed with shingles.

Very sore and tight left arm, same arm for injection, with a small lump or knot. Lump/knot is near back/shoulder and armpit. Pain radiates from spot and is painful to touch.

Patient states that three weeks ago he received dose number 2 of Pfizer covid 19 vaccination. Within the next few days he developed joint pain and swelling both hands and right knee

I got shingles about one month after the second dose. I had severe pain around my spine and back on Friday (4/23/2021) and by the next morning developed red bumps on the left side of my nose that I at first mistook for acne. They produced a very tiny amount of white liquid secretion. The bumps turned darker and I got a red rash on the left side of my nose. The left side of my face as well as the lymph nodes around my collar area swelled up. By Tuesday morning, it spread to my left eye, so I went to the ER where they started me on two new antibiotics. After none of the antibiotics worked, I started an antiviral (acyclovir) and antiviral eye drops and started to improve. The rash and swelling reduced and no new blisters have formed. The doctor and I both thought it likely I had shingles.

I've developed hives around my midsection. They are mostly 2mm in diameter and about as dense as 6 spots per square inch. They are itchy and swollen. I started noticing the effect about 4 days after the second vaccination, but I didn't make the connection to the vaccination as being a cause until 6 days after. I've started to apply over-the-counter anti-itch cream as needed.

My entire world has unraveled since getting this shot. Been to 4 ERs for systemic inflammation and neurological symptoms. Written off a psycho and about to be committed, but was brilliant. I believe I was given an undiluted dose of Pfizer without diluent, and became psychotic, and furthermore I believe my parents, who also got it, have had their judgement affected as well. They have been a lot less urgent with concern for their welfare of me since the shot. All they do is sleep all the time, wouldn't take me to the ER even when I was having trouble reading and staggering around. I understand I have no credibility here, but please look into this matter seriously, and not just the ravings of a crazy person.

I have never experienced any type of allergic reaction to Honey Bee Stings I was stung a a few times 4 weeks ago with no issues. I was stung once on my right index finger post Covid Vaccine and within 10 min of being stung broke out in a major rash, hives and swelling all over my body including face, lips, tongue. After a large dose of Benadryl it finally stopped swelling after 15 min-30min after taking them. The rash, hives and swelling went away after 3 hours. I have never experienced any kind of swelling or rash to beestings of any kind, especially not honeybees.

severe headaches; strong pain in my head, my left arm and left eye; strong pain in my head, my left arm and left eye; light pressure during the morning in my head not as severe as the other days; whole body turned red; bumps; itchy; nausea; stomach ache; eyes were numb; left arm was numb; rash all over his body; chills; flu symptoms; Caller (male, age 33) spoke already to someone prior to Pfizer and gave information on his experience with the Pfizer covid vaccine. "I took the first dose of the Pfizer vaccine on Saturday 17APR2021. I got a severe reaction from the Pfizer vaccine. I got the normal chills the next day and flu symptoms. From the next day to day 5 I got severe headaches, strong pain in my head, my left arm and left eye. I took Tylenol and ibuprofen within those days. The Tylenol didn't help at all, ibuprofen 200mg didn't do much. Yesterday I went to the ER because I had light pressure during the morning in my head not as severe as the other days, in the afternoon I had a tight pressure in my head so I took 2 tablets of extra strength Tylenol, the headache went away but within an hour I had a bad reaction. My whole body turned red, bumps, itchy. It was bad. It was bizarre because I've never had reaction to Tylenol prior. I never had that before yesterday. It was the first time. They gave me a shot of steroids. The doctor didn't know if it was a bad reaction to the Pfizer reaction (said it would usually occur within 4 hours of getting the vaccine) or the mix of the Tylenol and the pfizer vaccine together. He had no clue. But he had not seen a reaction of the vaccine at 5 days later. He said I could have reacted late, or the Tylenol and Pfizer vaccine together had a bad reaction. I had covid late Jan of this year. The vaccine more interaction due to that if I had immunity to it. It was so bad I don't know if it's possible to wait 2 months for the 2nd shot. I heard the first dose 80-90 percent immunity or even more. With my body I never had this reaction. Today I'm a whole lot better (day 6). I am too putting too much, should I wait 90 days other say 4 weeks. What to do about the 2nd dose? How about using antihistamines during/after my second dose? What about Tylenol or Ibuprofen?" I had a side effect after the first dose of the vaccine. Should I get the second dose? e-transmitting potential duplicate AE. Caller said he didn't give PCP information to the safety agent. He did not have. Response: Spoke from EUA PI (Revised: 06 April 2021) under Post Authorization Experience Fact Sheet for Recipients and Caregivers (Revised: 06 April 2021) under section WHAT ARE THE RISKS OF THE PFIZER-BIONTECH COVID-19 VACCINE? As noted in the Fact Sheet for Recipients, you should not get the Pfizer-BioNTech COVID-19 Vaccine if you had a severe allergic reaction after a previous dose of the vaccine or if you had a severe allergic reaction to any ingredient of the vaccine. The decision to receive the second dose for any other reason cannot be made by Pfizer. We refer you to speak to your healthcare provider about the risks of the vaccine compared to the risks of potentially not being fully protected against COVID-19 infection. Your healthcare provider knows your health situation and has access to information that can better help inform this decision. Request Name: Product: PFIZER-BIONTECH COVID-19 VACCINE Caller (male, age 33) spoke already to someone prior to Pfizer MI and gave information on his experience with the Pfizer covid vaccine. "I took the first dose of the Pfizer vaccine on Saturday 17APR2021. I got a severe reaction from the Pfizer vaccine. I got the normal chills the next day and flu symptoms. From the next day to day 5 I got severe headaches, strong pain in my head, my left arm and left eye. I took Tylenol and ibuprofen within those days. The Tylenol didn't help at all, ibuprofen 200mg didn't do much. Yesterday I went to the ER because I had light pressure during the morning in my head not as severe as the other days, in the afternoon I had a tight pressure in my head so I took 2 tablets of extra strength Tylenol, the headache went away but within an hour I had a bad reaction. My whole body turned red, bumps, itchy. It was bad. It was bizarre because I've never had reaction to Tylenol prior. I never had that before yesterday. It was the first time. They gave me a shot of steroids. The doctor didn't know if it was a bad reaction to the Pfizer reaction (said it would usually occur within 4 hours of getting the vaccine) or the mix of the Tylenol and the pfizer vaccine together. He had no clue. But he had not seen a reaction of the vaccine at 5 days later. He said I could have reacted late, or the Tylenol and Pfizer vaccine together had a bad reaction. I had covid late Jan of this year. The vaccine more interaction due to that if I had immunity to it. It was so bad I don't know if it's possible to wait 2 months for the 2nd shot. I heard the first dose 80-90 percent immunity or even more. With my body I never had this reaction. Today I'm a whole lot better (day 6). I am too putting too much, should I wait 90 days other say 4 weeks. What to do about the 2nd dose? How about using antihistamines during/after my second dose? What about Tylenol or Ibuprofen?" Caller wanted to know if his reactions could be due to him having covid before and if it was safe to get the covid vaccine after having covid infection. Response: Spoke from EUA PI (Revised: 06 April 2021) CLINICAL TRIAL RESULTS AND SUPPORTING DATA FOR EUA The study excluded participants who were immunocompromised and those who had previous clinical or microbiological diagnosis of COVID-19. Spoke from attached document and emailed as requested. Request Name: Product: PFIZER-BIONTECH COVID-19 VACCINE Caller (male, age 33) spoke already to someone prior to Pfizer MI and gave information on his experience with the Pfizer covid vaccine. "I took the first dose of the Pfizer vaccine on Saturday 17APR2021. I got a severe reaction from the Pfizer vaccine. I got the normal chills the next day and flu symptoms. From the next day to day 5 I got severe headaches, strong pain in my head, my left arm and left eye. I took Tylenol and ibuprofen within those days. The Tylenol didn't help at all, ibuprofen 200mg didn't do much. Yesterday I went to the ER because I had light pressure during the morning in my head not as severe as the other days, in the afternoon I had a tight pressure in my head so I took 2 tablets of extra strength Tylenol, the headache went away but within an hour I had a bad reaction. My whole body turned red, bumps, itchy. It was bad. It was bizarre because I've never had reaction to Tylenol prior. I never had that before yesterday. It was the first time. They gave me a shot of steroids. The doctor didn't know if it was a bad reaction to the Pfizer reaction (said it would usually occur within 4 hours of getting the vaccine) or the mix of the Tylenol and the pfizer vaccine together. He had no clue. But he had not seen a reaction of the vaccine at 5 days later. He said I could have reacted late, or the Tylenol and Pfizer vaccine together had a bad reaction. I had covid late Jan of this year. The vaccine more interaction due to that if I had immunity to it. It was so bad I don't know if it's possible to wait 2 months for the 2nd shot. I heard the first dose 80-90 percent immunity or even more. With my body I never had this reaction. Today I'm a whole lot better (day 6). I am too putting too much, should I wait 90 days other say 4 weeks. What to do about the 2nd dose? How about using antihistamines during/after my second dose? What about Tylenol or Ibuprofen?" Caller wanted to know about delaying his second dose; information on timing of dose 2. Response: Spoke from attached document and emailed as requested. Request Name: Caller (male, age 33) spoke already to someone prior to Pfizer MI and gave information on his experience with the Pfizer covid vaccine. "I took the first dose of the Pfizer vaccine on Saturday 17APR2021. I got a severe reaction from the Pfizer vaccine. I got the normal chills the next day and flu symptoms. From the next day to day 5 I got severe headaches, strong pain in my head, my left arm and left eye. I took Tylenol and ibuprofen within those days. The Tylenol didn't help at all, ibuprofen 200mg didn't do much. Yesterday I went to the ER because I had light pressure during the morning in my head not as severe as the other days, in the afternoon I had a tight pressure in my head so I took 2 tablets of extra strength Tylenol, the headache went away but within an hour I had a bad reaction. My whole body turned red, bumps, itchy. It was bad. It was bizarre because I've never had reaction to Tylenol prior. I never had that before yesterday. It was the first time. They gave me a shot of steroids. The doctor didn't know if it was a bad reaction to the Pfizer reaction (said it would usually occur within 4 hours of getting the vaccine) or the mix of the Tylenol and the pfizer vaccine together. He had no clue. But he had not seen a reaction of the vaccine at 5 days later. He said I could have reacted late, or the Tylenol and Pfizer vaccine together had a bad reaction. I had covid late Jan of this year. The vaccine more interaction due to that if I had immunity to it. It was so bad I don't know if it's possible to wait 2 months for the 2nd shot. I heard the first dose 80-90 percent immunity or even more. With my body I never had this reaction. Today I'm a whole lot better (day 6). I am too putting too much, should I wait 90 days other say 4 weeks. What to do about the 2nd dose? How about using antihistamines during/after my second dose? What about Tylenol or Ibuprofen?" Caller wanted to know about using Benadryl during/after the second dose. Response: Spoke from attached document and emailed as requested. Request Name: Product: PFIZER-BIONTECH COVID-19 VACCINE Caller (male, age 33) spoke already to someone prior to Pfizer MI and gave information on his experience with the Pfizer covid vaccine. "I took the first dose of the Pfizer vaccine on Saturday 17APR2021. I got a severe reaction from the Pfizer vaccine. I got the normal chills the next day and flu symptoms. From the next day to day 5 I got severe headaches, strong pain in my head, my left arm and left eye. I took Tylenol and ibuprofen within those days. The Tylenol didn't help at all, ibuprofen 200mg didn't do much. Yesterday I went to the ER because I had light pressure during the morning in my head not as severe as the other days, in the afternoon I had a tight pressure in my head so I took 2 tablets of extra strength Tylenol, the headache went away but within an hour I had a bad reaction. My whole body turned red, bumps, itchy. It was bad. It was bizarre because I've never had reaction to Tylenol prior. I never had that before yesterday. It was the first time. They gave me a shot of steroids. The doctor didn't know if it was a bad reaction to the Pfizer reaction (said it would usually occur within 4 hours of getting the vaccine) or the mix of the Tylenol and the pfizer vaccine together. He had no clue. But he had not seen a reaction of the vaccine at 5 days later. He said I could have reacted late, or the Tylenol and Pfizer vaccine together had a bad reaction. I had covid late Jan of this year. The vaccine more interaction due to that if I had immunity to it. It was so bad I don't know if it's possible to wait 2 months for the 2nd shot. I heard the first dose 80-90 percent immunity or even more. With my body I never had this reaction. Today I'm a whole lot better (day 6). I am too putting too much, should I wait 90 days other say 4 weeks. What to do about the 2nd dose? How about using antihistamines during/after my second dose? What about Tylenol or Ibuprofen?" Caller wanted to know about using Tylenol or ibuprofen. Response: Due his reaction informed caller to speak with HCP or allergist regarding this. Follow-up #01 (23Apr2021): This is a follow-up spontaneous report received from a contactable reporter( patient). This male consumer (patient) reported that: Narrative case summary and further information: Patient Ethnicity: # Is the patient also the reporter? Yes Reporter type: Consumer or other non health professional Specify Consumer or other non health professional: self Dates for massive severe headache: (From: Unspecified To: Unspecified) Reporter seriousness for massive severe headache: Unspecified Dates for had chills: (From: Unspecified To: Unspecified) Reporter seriousness for had chills: Unspecified Dates for nausea: (From: Unspecified To: Unspecified) Reporter seriousness for nausea: Unspecified Dates for little bit of a stomach ache and nausea: (From: Unspecified To: Unspecified) Reporter seriousness for little bit of a stomach ache and nausea: Unspecified Is Pfizer Vaccine a Pfizer product? Yes Pfizer Vaccine manufacturer: Unspecified Dates for Pfizer Vaccine: (Start: 17 Apr 2021 Stop: Unspecified) NDC number of Pfizer Vaccine: Unknown Expiry Date of Pfizer Vaccine: Unknown Why was the patient taking Pfizer Vaccine (Verbatim): just to get vaccinated for covid Other Products: No Patient History: No Investigation Assessment: No Additional Context: Caller states he is calling about the Pfizer Vaccine and has a couple of questions in his experience with this; states he had the 1st dose of the Pfizer Vaccine on 17Apr2021 and had a really severe reaction with it and basically through the next day he had normal things that are normal but the last 5 days he has had a massive severe headache and overnight had chills then his symptom was nausea and headache and everything else; states the following four days after that he had a little bit of a stomach ache and nausea which were not as bad but had a severe headache. States he had a severe body reaction on Thursday 22Apr2021 and today he is 100 percent better. HCP information: Caller declined to provide the HCP information as he does not have that with him at this time. States he took Tylenol yesterday and the whole week which is Tylenol Extra Strength 500mg and yesterday took two tablets and on the 2nd day Sunday 18Apr2021 he took about 5 tablets the whole day and the bottle has expiry date 2024 and lot ABC207. States the emergency room gave him a steroid shot he can't find the name of and has no dosage, lot number to provide. States the emergency room gave him a medication Prednisone that he is to take for the next 5 days and is required to take it this week and it is 5mg in an orange pharmacy bottle with no lot or expiry date because it is an orange pharmacy bottle. States he took Ibuprofen 200mg with expiry date Dec2022 and lot WJ02713. States the Tylenol and Ibuprofen were the two ones that were recommended to take and he took them and the Tylenol and Ibuprofen gave him a severe headache and it was really really bad on the 5th day which was yesterday and the pressure from the headache he could feel and it was a slight pressure and was uncomfortable and the left side of his body and his eyes were numb and the left arm was numb; states after that the next day on the 5th day, he had a tight pressure in his head and in late afternoon the pain was starting to get tighter with a severe headache; states today is the 6th day. Caller states he took Tylenol again and a half hour later he had a severe body rash all over his body and had to go to the emergency room to get a steroid shot from it and the rash is not ongoing and he went to the ER yesterday and they have him the steroid shot at that time and a medication to take for the next 5 days which caller said is the Prednisone. States he had the really bad rash all over his body and it was really really red and itchy and he had bumps coming up so went to the emergency room and they could not tell if it was due to the Tylenol or part of the Pfizer Vaccine; states he had taken Tylenol a couple of times in 5 days and was fine and then took Tylenol yesterday and had the severe reaction. States he had been reading a lot and is really worried about taking the 2nd dose of the Pfizer vaccine and is debating on waiting two months before getting the 2nd one and his general practitioner can't find anything wrong and can't say the reported event is due to the Pfizer Vaccine; states a lot of people get a reaction in 6 days he has found in his reading; states his HCP has some patients that had reactions within 4 hours and not in 5 days after the vaccine and states he has no patient information or lot numbers for their vaccines to report. States he had covid in late January 2021 and that can react a lot with the Pfizer Vaccine and he understands that and does not know if this is actually an allergy of the vaccine in these few days of the last 7 days or if is the Tylenol reacting with the vaccine. States he realized that having had covid in late January could affect him a lot more with the vaccine. Caller states he only has the medication for Prednisone that he was given to take for the reaction from yesterday. VACCINE SUPPLEMENTAL FORM Patient Age at Time of Vaccination in Years: 33 Vaccine Lot Number: EW0162 Time the Vaccination Was Given: 10:35am Vaccine Lot Expire Date: unknown Anatomical Location of Administration of Pfizer vaccine considered as suspect: left arm History of all previous immunization with the Pfizer vaccine considered as suspect: This was the 1st dose of the Pfizer vaccine administered on 17Apr2021. Additional Vaccines Administered on Same Date of the Pfizer Suspect: None Did any AE(s) require a visit to ER or MD office?: Yes, emergency room but not the HCP office. If the patient was hospitalized, how many days was the hospital stay?: n/a Prior Vaccinations (within 4 weeks): None Patient's Medical History: see additional context Family Medical History Relevant to AE(s): None Relevant Tests: None PSCC Communication: PC filed. Caller was provided with the report reference number, contact information and hours of operation for Covid Line, # option #3, Monday to Friday 8:00am to 8:00pm EST and Saturday and Sunday 9:00am to 3:00pm EST; caller was placed on hold; due to larger than normal call volumes, the caller agreed to be placed into the queue for the next available agent. Is there a Product Complaint: Yes Description of Product Complaint: Description of complaint: Vaccine Supplemental Form completed in additional context. Caller states he is calling about the Pfizer Vaccine; states he had the 1st dose of the Pfizer Vaccine and had a really severe reaction with it;States he realized that having had covid in late January could affect him a lot more with the vaccine. States he had covid in late January 2021 and that can react a lot with the Pfizer Vaccine and he understands that and does not know if this is actually an allergy of the vaccine in these few days of the last 7 days or if is the Tylenol reacting with the vaccine.States the Tylenol and Ibuprofen were the two ones that were recommended to take and he took them and the Tylenol and Ibuprofen gave him a severe headache and it was really really bad on the 5th day which was yesterday and the pressure from the headache he could feel and it was a slight pressure and was uncomfortable and the left side of his body and his eyes were numb and the left arm was numb; states after that the next day on the 5th day, he had a tight pressure in his head and in late afternoon the pain was starting to get tighter with a severe headache.States he took Tylenol yesterday and the whole week which is Tylenol Extra Strength 500mg and yesterday took two tablets and on the 2nd day Sunday 18Apr2021 he took about 5 tablets the whole day and the bottle has expiry date 2024 and lot ABC207. States he took Ibuprofen 200mg with expiry date Dec2022 and lot WJ02713. No follow-up attempts are needed; information about lot/batch number cannot be obtained. This is a spontaneous report from a contactable consumer or other non hcp. A male patient of an unspecified age received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 17Apr2021 10:35 (Batch/Lot Number: EW0162) as SINGLE DOSE for covid-19 immunisation . The patient medical history was not reported. Concomitant medication(s) included paracetamol (TYLENOL) taken for an unspecified indication, start and stop date were not reported. The patient experienced chills (chills) (medically significant) on 18Apr2021 with outcome of unknown , flu symptoms (influenza) (medically significant) on 18Apr2021 with outcome of unknown , severe headaches (headache) (medically significant) on an unspecified date with outcome of unknown , strong pain in my head, my left arm and left eye (pain in extremity) (medically significant) on an unspecified date with outcome of unknown , strong pain in my head, my left arm and left eye (eye pain) (medically significant) on an unspecified date with outcome of unknown , light pressure during the morning in my head not as severe as the other days (head discomfort) (medically significant) on an unspecified date with outcome of unknown , whole body turned red (erythema) (medically significant) on an unspecified date with outcome of unknown , bumps (swelling) (medically significant) on an unspecified date with outcome of unknown , itchy (pruritus) (medically significant) on an unspecified date with outcome of unknown , nausea (nausea) (medically significant) on an unspecified date with outcome of unknown , stomach ache (abdominal pain upper) (medically significant) on an unspecified date with outcome of unknown , eyes were numb (hypoaesthesia eye) (medically significant) on an unspecified date with outcome of unknown , left arm was numb (hypoaesthesia) (medically significant) on an unspecified date with outcome of unknown , rash all over his body (rash) (medically significant) on an unspecified date with outcome of unknown. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on Jan2021 . The action taken in response to the event(s) for bnt162b2 was not applicable. This is a spontaneous report from a contactable consumer or other non hcp. A male patient of an unspecified age received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 17Apr2021 10:35 (Batch/Lot Number: EW0162) as SINGLE DOSE for covid-19 immunisation . The patient medical history was not reported. Concomitant medication(s) included paracetamol (TYLENOL) taken for an unspecified indication, start and stop date were not reported. The patient experienced chills (chills) (medically significant) on 18Apr2021 with outcome of unknown , flu symptoms (influenza) (medically significant) on 18Apr2021 with outcome of unknown , severe headaches (headache) (medically significant) on an unspecified date with outcome of unknown , strong pain in my head, my left arm and left eye (pain in extremity) (medically significant) on an unspecified date with outcome of unknown , strong pain in my head, my left arm and left eye (eye pain) (medically significant) on an unspecified date with outcome of unknown , light pressure during the morning in my head not as severe as the other days (head discomfort) (medically significant) on an unspecified date with outcome of unknown , whole body turned red (erythema) (medically significant) on an unspecified date with outcome of unknown , bumps (swelling) (medically significant) on an unspecified date with outcome of unknown , itchy (pruritus) (medically significant) on an unspecified date with outcome of unknown , nausea (nausea) (medically significant) on an unspecified date with outcome of unknown , stomach ache (abdominal pain upper) (medically significant) on an unspecified date with outcome of unknown , eyes were numb (hypoaesthesia eye) (medically significant) on an unspecified date with outcome of unknown , left arm was numb (hypoaesthesia) (medically significant) on an unspecified date with outcome of unknown , rash all over his body (rash) (medically significant) on an unspecified date with outcome of unknown. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on Jan2021 . The action taken in response to the event(s) for bnt162b2 was not applicable.

After getting my second shot of Pfizer COVID vaccine, I waited for 30 minutes according to the protocol and I left for home after the wait. While on the way home, I developed rash on my both arms and felt dizzy. I pulled over to a parking lot but before I could park my car, I passed out. I couldn't control my car and I bumped into another parked car. All this happened in a matter of 15 seconds. My wife and my daughter was with me. When I regained consciousness, my wife was doing CPR on. A bystander in the parking lot called EMS for me.

Information obtained from mother. Pt. c/o a lump on left shoulder near the neck about 1 weeks after 1st covid vaccination. It is about 1/2" in size, oval in shape. It is tender but not painful. The lump has not changed in size. He has not sought care because of having no insurance. Mom was given names of local clinics for uninsured.

swollen lymph nodes in the area of the clavicle post 2nd dose; This is a spontaneous report from a contactable reporter reporting for a 33-year-old male patient who received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: UNKNOWN) via an unspecified route of administration into the right arm on 15Feb2021 (at the age of 33-year-old) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Unknown if any allergies presented. On 15Mar2021, the patient experiencing swollen lymph nodes in the area of the clavicle post second dose. Prior to vaccination, the patient was not diagnosed with COVID-19 and unknown if tested post vaccination. No treatments received. It was unknown if the patient received any other vaccines within four weeks prior to the COVID vaccine. Unknown if since the vaccination, the patient had been tested for COVID-19 and also allergies to medications, food or other products. Reporter learned of the adverse event that reporter reported on behalf of someone on 26Mar2021, the same day it was reported. Outcome of the event was recovering. No follow-up attempts are needed. No further information is expected.

Swollen lymph nodes in armpit on right arm. The same arm where the shot was given. Lot of fluid in armpit. Tender as well. This was my second Pfizer Covid shot.

Second covid-19 vaccine (Pfizer) on 6/1/21 Says about 5 minutes later he got a temporary electrical pain that radiated from the right scapula up into the right scalp Also developed injection site pain, fever, chills, severe arthralgias within the first 24-48 hours Then on 6/4, developed right neck and scalp rash Burning, electrical pain and also some swelling Also on the right anterior neck area Some ear pain No facial involvement Diagnosed with Shingles June 7, 2021.

Swollen auxiliary lymph nodes following both doses. The ones on my left side have been swollen now for 3 months.

Continuous muscle pain, stiffness, swelling in legs, primarily the lower half; intermittent muscle pain in left arm near armpit

Other diseases of bronchus, not elsewhereclassified Onset: 20-Apr-20213:06 Comments: Onset Date: 20210417 Acute respiratory failure with hypoxia Onset: 20-Apr-20213:06 Comments: Onset Date: 20210417 Hypertensive heart disease with heart failure Onset: 20-Apr-20213:06 Comments: Onset Date: 20210417 Heart failure, unspecified Onset: 20-Apr-20213:06 Comments: Onset Date: 20210417 ABG (arterial blood gas) abnormal Onset: 20-Apr-20213:06 Comments: Onset Date: 20210417 Acute kidney failure, unspecified Onset: 20-Apr-20213:06 Comments: Onset Date: 20210417 Polycythemia Onset: 20-Apr-20213:06 Comments: Onset Date: 20210417 Hyperglycemia, unspecified Onset: 20-Apr-20213:06 Comments: Onset Date: 20210417 ARDS (adult respiratory distress syndrome) Onset: 18-Apr-202116:37 Comments: Onset Date: 20210417 Shock Onset: 18-Apr-202116:37 Comments: Onset Date: 20210417 Acute respiratory failure Onset: 18-Apr-202116:37 Comments: Onset Date: 20210417 Aspiration pneumonitis Onset: 18-Apr-202116:37 Comments: Onset Date: 20210417 Abnormal CXR Onset: 18-Apr-202116:37 Comments: Onset Date: 20210417 Cardiogenic shock Onset: 17-Apr-202114:26 Comments: Onset Date: 20210417 Cardiac arrest Onset: 17-Apr-202114:26 Comments: Onset Date: 20210417 Pulmonary infiltrate Onset: 17-Apr-202112:23 Comments: Onset Date: 20210417 Acute respiratory failure with hypoxia Onset: 17-Apr-202112:23 Comments: Onset Date: 20210417 Aspiration into airway Onset: 17-Apr-202112:23 Abnormal EEG Onset: 25-May-202112:11 Comments: Onset Date: 20210419 Encephalopathy Onset: 25-May-202112:11 Comments: Onset Date: 20210419 Acute thrombosis of right cephalic vein Onset: 19-May-202111:49 Comments: Onset Date: 20210425 Cardiomegaly Onset: 30-Apr-20216:24 Comments: Onset Date: 20210426 Ventricular fibrillation Onset: 29-Apr-20212:21 Comments: Onset Date: 20210427 Coma Onset: 27-Apr-202114:09 Comments: Onset Date: 20210422 Postoperative hemorrhage involving circulatorysystem following circulatory system procedure Onset: 26-Apr-202112:27 Comments: Onset Date: 20210421 Personal history of ECMO Onset: 26-Apr-202112:23 Comments: Onset Date: 20210419 Presence of ventricular assist device Onset: 26-Apr-202112:23 Comments: Onset Date: 20210419 Frequent PVCs Onset: 24-Apr-202112:49 Comments: Onset Date: 20210424 Presence of other vascular implants and grafts Onset: 24-Apr-20215:43 Comments: Onset Date: 20210418 Obesity, unspecified Onset: 24-Apr-20214:58 Comments: Onset Date: 20210417 Body mass index [BMI] 45.0-49.9, adult Onset: 24-Apr-20214:58 Comments: Onset Date: 20210417 Hyperthermia Onset: 23-Apr-202121:40 Comments: Onset Date: 20210419 Ventricular tachyarrhythmia Onset: 23-Apr-202112:14 Comments: Onset Date: 20210423 This code is used to indicate to the billing staff thatservices have been rendered and the chargeneeds to be coded. Onset: 22-Apr-202113:08 Comments: Onset Date: 20210421 Cardiomyopathy Onset: 22-Apr-202111:48 Comments: Onset Date: 20210422

Arm pain and fatigue. Waking up with shooting pain in arm. Numbness and fatigue in legs. Persistent fatigue and muscle twitching still two months after injection. In forearms, thighs, calves, buttocks, eye area. Neck stiffness. inflamed lymph nodes. longer recovery times from exercise. mild to moderate chest pain. severe shoulder pain return in left arm after exercise. Occasional

This is a spontaneous report from a contactable consumer (patient himself). A 33-years-old male patient received (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection) via an unspecified route of administration in arm left on 30May2021 at 11:00 (at the age of 33-years-old) (Lot Number: EW0175, Expiry date: Unknown) as dose 2, single for COVID-19 immunization. Vaccination Facility Type was pharmacy/ drug store. The patient medical history was reported as nothing. Concomitant medications included colecalciferol, dicalcium malate, durapatite, genistein, menaquinone-7, sodium phosphate dibasic, zinc bis glycinate chelate (FOSTEUM PLUS); colecalciferol (VITAMIN D) and probiotics both taken for an unspecified indication, start and stop date were not reported. Known allergies reported as no. Patient previously received first dose of (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection), via an unspecified route of administration in arm left on 09Apr2021 at 12:00 PM (at the age of 33-years-old) (Lot Number: EW0173, Expiry date: Unknown) as single for COVID-19 immunization and did not experience any adverse reaction. Patient did not have COVID prior vaccination and patient was not tested for COVID post vaccination. If other vaccine in four weeks was no. The patient experienced chronic urticaria, lips swollen, rash, hives, tiredness and swollen feet on 02Jun2021 05:00. The events resulted in doctor or other healthcare professional office/clinic visit. Patient was treated with Methylprednisolone in response to the events. The outcome of the events was not recovered. Follow-up attempts are completed. No further information is expected.

Armpit swelling; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 31Mar2021 at 08:00 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies to medications, food, or other products. The patient did not receive any concomitant medications. Prior to the vaccination, it was unknown whether the patient was diagnosed with 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 vaccination. On 02Apr2021 at 12:00 the patient experienced armpit swelling. The event did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event armpit swelling was not recovered at the time of the report. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Swollen Aux lymph nodes under both arms. Larger on the left side. Swollen for more than 3 months out from vaccine.

Hives all over body, itchiness, swollen lips, face hands and feet. Pain and wormth in the swollen areas.

Swollen lymph node under left armpit.; This is a spontaneous report from a non-contactable consumer, the patient. A 33-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EW0169) via an unspecified route of administration in the left arm on 17Apr2021 at 15:15 ( at the age of 33-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient did not have any past medication history. The patient did not receive any other medications within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 20Apr2021 at 12:00, the patient experienced swollen lymph node under left armpit. The clinical outcome of the event swollen lymph node under left armpit was not recovered at the time of this report. No follow-up attempts are possible. No further information is expected.

Productive cough; Swollen lymph nodes on neck; Severe body aches; Chills; Minor headache; This is a spontaneous report from a contactable other healthcare professional, the patient. A 34-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: Ek5730, via an unspecified route of administration on 29Dec2020 at 13:30 (at the age of 34 years old) as a single dose in the right arm for COVID-19 vaccination. Medical history included fibromyalgia, anxiety disorder, and allergy to amoxicillin from an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included omeprazole 40mg and duloxetine 120 mg, both for unknown indications from unknown dates and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The vaccine was given at a hospital. On 29Dec2020 at 18:30, the patient experienced severe body aches, chills, minor headache, and swollen lymph nodes on neck. On 30Dec2020, the patient experienced productive cough. The patient did not receive treatment for the events. The clinical outcome of body aches, chills, minor headache, swollen lymph nodes on neck, and productive cough was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.

Immediate pain and loss of range of movement of left shoulder. Physical examination today demonstrates a healing injection site which is fairly superior on the left shoulder, and abduction of the left shoulder which is limited secondary to pain. Patient's physician's impression is that he has a subdeltoid bursitis which was temporally associated to the COVID-19 vaccination. (SIRVA)

Axillary lymphadenopathy - left side, starting around 24-36 hours after the second dose and continuing beyond at least 72 hours (current time). Some improvement in swelling with naproxen. Mild pain.

Injection site is very sore; arm swelling; fatigue; This is a spontaneous report from a contactable Physician (patient). A 34-year-old male patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK9321), via an unspecified route of administration on 06Jan2021 at 08:00 at single dose in left arm for covid-19 immunization. There were no medical history or concomitant medications. The patient experienced injection site was very sore, arm swelling, and fatigue on 06Jan2021 at 08:00. The patient did not receive treatment for the events. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination, and the patient had not been tested for COVID-19 since vaccination. The outcome of the events was resolving.

1/3/21-1/5/21: Low grade fever, muscle aches. 1/6-1/11: Higher fever, chills, sore throat, cervical lymphadenopathy, muscle aches, decreased appetite, nausea, dehydration, lethargy, headache, perfuse sweating. 1/12-1/16: Muscle aches continued, lethargy, headache, intermittent fever, nausea. 1/17: Symptoms improving. Poor appetite continues.

Felt generalized malaise and left axillary lymphadenopathy one day after the vaccine (the very next morning). Took acetaminophen and was back to normal two days after the vaccine except for a very tender, enlarged left axillary lymphadenopathy that is persisting, now four days since the vaccination.

Patient received his COVID-19 (Pfizer) off base. Received first dose on 6 Jan 2021 and his second dose on 28 Jan 2021. Patient had his firs rash develop one week after his first dose. Developed rash to right upper arm that extended down to right hand, reports redness and swelling to right hand. Placed on Prednisone 50mg Daily x 5 days and Zyrtec daily. Woke up on 29 Jan 2021 with rash to right and left hands, extending fro wrists to thumbs and index fingers. No itching, no pain, no warmth. Skin red, raised. Started on Triamcinolone cream, continue zyrtec 10mg, and motrin 800mg PRN.

-Mild-moderate fatigue -Moderate bilateral upper body soreness, specifically axillary and neck areas with lymphadenopathy -Mild-moderate fever (99.7*F-100*F) -Mild-moderate bilateral upper extremity peripheral hypersensitivity (burning/pain with light touch from elbows to hands)

Shoulder soreness. Left supraclavicular lymphadenopathy. One swollen node was noted about one week after the first dose. The node was mobile and nontender. One day after the second dose was administered on 2/5/21, a second non-tender mobile node was found lateral to the first node in the left supraclavicular region. Supraclavicular nodes on the right were found to be palpable but not nearly as large.

Swelling Lymph node on left arm pit; This is a spontaneous report from a contactable Healthcare Professional reporting for himself. A 34-years-old male patient received the second dose of BNT162B2 Pfizer-BioNTech COVID-19 Vaccine, Lot number EL3247, in Hospital, via intramuscular route in left arm on 25Jan2021 at 11:00 at single dose for COVID-19 immunization. The patient's medical history was not reported. The patient had previously received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 Vaccine, lot number EL0142, via intramuscular route in left arm on 05Jan2021 at 11:00. The patient was not tested for COVID-19 after the vaccination. There were no concomitant medications. On 27Jan2021 at 02:00 AM the patient experienced swelling lymph node on left arm pit. No treatment was received for the event. The reported event had not resolved yet at the time of the report.

joint/muscle ache on left arm (site of injection); joint/muscle ache on left arm (site of injection); joint/muscle ache on left arm (site of injection); Swelling of left arm and left armpit (possibly lymph node swelling); Swelling of left arm and left armpit (possibly lymph node swelling); Unable to lift left arm past shoulder; mild fever; full body ache/pain; slight disorientation when standing; headache; fatigue; This is a spontaneous report from a contactable consumer (patient). A 34-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number and expiration date not reported) via an unspecified route of administration on the left arm on 27Jan2021 17:45 at a single dose for COVID-19 immunization. Medical history included latex allergy. Concomitant medication included influenza vaccine (TRIVALENT INFLUENZA VACCINE) on 11Jan2021. The patient previously received first dose of BNT162B2 on 06Jan2021 for COVID-19 immunisation (first dose at 05:45 PM, left arm). First symptom: headache/fatigue at 3:30 pm on 28Jan2021, sleep at 11 pm. Woke up at 8 am 29Jan2021, symptoms include mild fever (temperature not taken), severe headache, full body ache/pain, slight disorientation when standing. Symptoms alleviated by taking 1 acetaminophen (TYLENOL) pill (extra strength). Symptoms returned at 4 pm, another Tylenol pill taken to relieve symptoms. On 30Jan2021, mild symptoms in the morning including headache, joint/muscle ache on left arm (site of injection). Treated with Tylenol. Swelling of left arm and left armpit (possibly lymph node swelling). Unable to lift left arm past shoulder. On 31Jan2021, persisting mild headache and left arm aches, now able to lift left arm past shoulder, but with some discomfort. Treat with Tylenol. On 01Feb2021, mild headache still persisting, significantly reduced swelling of left arm/armpit. Full motion with left arm without discomfort. Treat with Tylenol. Events were reported as non-serious; did not result in death, was not life-threatening, did not cause/prolonged hospitalization, was not disabling/incapacitating and did not cause congenital anomaly/birth defect. The facility where the vaccine was administered was in a Public Health Clinic/Veterans Administration facility. There were no other medications the patient received within 2 weeks of vaccination. Since the vaccination, the patient has not been tested for COVID-19. Prior to vaccination, the patient was not diagnosed with COVID-19. Outcome of the event swelling arm was unknown while recovering for the other events. Information on the lot/batch number has been requested.

swollen glands left side only; This is a spontaneous report from a contactable consumer (patient). A 34-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) lot number ej1686 and expiry date unknown, via unspecified route of administration at the left arm on 11Jan2021 12:00 PM at single dose for Covid-19 immunization in a hospital. Medical history was none. The patient's concomitant medications were not reported. The patient has no other medications received within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 30Jan2021 12:00 PM, the patient experienced swollen glands left side only. The patient has not been tested for COVID-19 since vaccination. The patient did not received treatment due to the events. The outcome of the event was recovering. The reporter considered the events non-serious; did not results in death, was not life threatening, did not cause/prolong hospitalization, was not disabling/incapacitating, and no congenital anomaly/birth defect. No follow-up attempts are possible. No further information is expected.

Anaphylactic reaction (throat swelling), sweaty, cold skin, elevated blood pressure (211/137 mmHg) gradual onset within 15 minutes of vaccine administration.

Muscle pain and weakness beginning 2/28/2021, hospitalized 3/2/2021-3/8/2021 for rhabdomyolysis (peak CK = 112,000) and severe transaminitis (ALT and AST in the 2000's). No preceding injury or trauma, no drug or excessive alcohol use. By 3/19/2021 patient still unable to get out of chair without using arms, significant proximal mm weakness. Inflammatory markers elevated and CK and liver enzymes still surprisingly high. Re-hospitalized 3/22/2021. Still in hospital, improving, on date of report (3/23/2021).

About 10 days after receiving the vaccine my left arm became very sore and the lymph node under my arm became swolen and stayed that way for several days

Approximately 6-7 hours after injection, I experienced mild facial swelling and redness. No pain or other rashes. No respiratory effects. No medications were taken to treat the symptoms, and they had subsided by morning. Moderate arm pain near injection site started around 2-3am, and has continued throughout the next day.

nine hours after injections: fever, muscle pain, nausea, chills, joint pain, headache, injection site pain, vomiting, muscle spasms, lymph node appearance in neck, sleepiness, malaise, vivid dreams, unable to sleep well, or function.

I am experiencing swelling in my left armpit (approximately 30 hours after my second dose of Pfizer vaccine). The swelling is causing my left armpit to be tender and is about the size of a golf ball. I am not currently under treatment for this side effect.

possibly infected right breast; inflamed; Swollen; nipple (lymph node); nipple (lymph node); This is a spontaneous report from a contactable consumer (Patient). A 34-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EN6207), dose 1st via an unspecified route of administration, administered in Left arm on 23Mar2021 13:15 as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced possibly infected right breast, inflamed, swollen, nipple (lymph node) all were on 26Mar2021 12:00. No other vaccine in four weeks. No COVID prior vaccination. No treatment was given for events. The patient has not tested COVID-19 Since the vaccination. The outcome of the events was recovering.

next day had leg pain and swelling on right side. over the next several days, significant bruising, swelling and pain

I had a nasty zit on the back of my neck, popped it, and my immune response was extreme. Initial: Itching and burning through my neck and shoulders, and swollen lymph nodes in neck and collarbone. I began sweating at night profusely and losing weight. I have had a lot of trouble sleeping. These symptoms continued in 24-48 hour cycles of flare ups until 04/19/2021 but finally seem to be abating. Progression: secondary symptoms appeared over the course of the month such as full body joint soreness, weakness, stiffness, stabbing pains (in the neck, arms, chest, and abdomen), blood pressure spikes, dry/sore throat, dry eyes, difficulty swallowing. Symptoms are similar to arthritis or other autoimmune diseases. Night sweats continue but are lighter. Weight loss continues but slower. Sleeping remains irregular.

Systemic: Lymph Node Swelling-Medium, Systemic: Numbness (specify: facial area, extremities)-Severe, Additional Details: Knot at injection site. Left arm, middle pinky numb & loss of sensation for top knukle (inch from top knuckle to finger tip). Sensation has still not returned. Contemplating seeking medical attention.

Cold like synptoms-post nasal drip; enlarged lymph nodes; sore throat; sore arm; general malaise; runny nose; wheezing; This is a spontaneous report received from a contactable other health care professional (patient him-self). A 34-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection and lot number: EL9269) via an unspecified route of administration to Left arm on 19Feb2021 12:15 at single dose for COVID-19 immunization. Patient medical history included ADHD, Anxiety, Depression, Psychosis, Ashthma and seasonal allergies. Patient concomitant medication included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL). On 19Feb2021 15:00 patient experienced with Cold like symptoms- post nasal drip, sore throat, sore arm, enlarged lymph nodes, general malaise, runny nose and wheezing. Patient did not receive any treatment for the events. Outcome of events was not recovered.

Patient complains of puffiness/ slight tingling on fingers. Provider noticed some 'whitish patches' on finger tips of right hand.

Body aches, swollen and sore lymphnodes near injection site, headache persistent for more than 3 days

34 y.o. male with history of depression admitted to the hospital on 4/23/2021 for chest pain and leg pain found to be due to Deep Vein Thrombosis and bilateral Pulmonary Embolism. Patient started on heparin infusion in the hospital with stabilization of vital signs then transitioned to apixaban at DVT/PE dosing prior to discharge

Severe expected symptom (9h-48h after injection): - swelling of arm - headache - chills/body aches - 102-104 degree fever (treated with Tylenol -- only medicine taken) Unexpected symptoms - vomiting, diarrhea (6h-18h after shot) - swollen lymph nodes in armpit of injected arm (12h-72h after shot) - dizziness/disorientation (6h-36h after shot)

localized pain and swelling to deltoid with ct showing multiple fluid collections concerning for abscess or fluid collections. required iv abx, admission and possible drainage.

As a clinical monitor, I was called over to assess a driver slumped over in his seat. He had just received the second dose of the Pfizer vaccine approximately 10 minutes earlier. The passenger (his fiance) said he was acting normal until she heard him grunt and then realized that he was passed out. While attempting to lay flat, I performed a jaw thrust that yielded a stridulous inspiration but was still unresponsive. He did not have a palpable carotid pulse. Paramedics was summoned emergently. Within 30-45 seconds, he awoke but was confused and amnestic to the event. He had no physical complaints and no significant medical or allergy history. I auscultated his larynx (no stridor) and his lungs (CTA). His initial vitals: BP 90/51 HR 61 VR 16 SaO2 100% An electrocardiogram demonstrated a sinus rhythm without ischemic changes or evidence of conduction delay. His glucose was 119. Over the next 30 minutes, he was able to drink two bottles of water and some orange juice. That said, he still said he "felt off." Repeat vital signs: BP 118/62 HR 69 SaO2 100%. The medics advised him to follow up with his doctor, preferably today. His fiance agreed to drive him to an ED near their home for a more thorough evaluation. I provided her my phone number to provide to the ED for any questions. His clinical syndrome was consistent with a syncopal episode associated with orthostatic hypotension. Low suspicion for anaphylaxis.

thoracic spine pain a few hrs after 2nd vaccine. persistent for a few weeks, then severe chest pain, resulting in ER visit and hospital admission. final diagnosis myocarditis. discharged in stable condition.

After first shot, knee joint slight fluid retention and moderate pain. When driving extended period of time knee pain shot to hip and was more than moderate. No history of joint pain. Second shot, still had knee pain then right shoulder pain when lifting arm. The joint pains have started to subside some and are only mild now. Starting about 6 days after second shot, occasional heart flutter and some fatigue throughout the day. This has been going on for 2-3 days now.

On 2 nd day after vaccine i developed red welts on my limbs ! I thought they would disappear but its been 20days ! The eelts are raised, red and itchy.

Swollen gland in armpit; flu like symptoms; This is a spontaneous report from a contactable consumer (patient). A 34-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration on 24Apr2021, (at age of 34-year-old) in left arm as single dose for COVID-19 immunisation. Medical history included asthma and turmeric allergy. Patient did not receive concomitant medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. On 03May2021, at 08:00PM, patient experienced swollen gland in arm pit, flu like symptoms. Events were considered non-serious by the reporter. Patient received second dose of vaccine on 15May2021 at 10:30AM in left arm. It was unknown if the patient received treatment for the events. Outcome of the events were unknown. Information on the lot/batch number has been requested

R axillary / ant/ lateral chest wall swelling with TTP. no erythema, warmth, bruising, swelling. direct injection site appears normal. no arm swelling

Neck lyph nodes swelling, under chin to collarbones, pancreatitis, never had prior occurance. Felt like liver was on fire, similar to gallbladder pain. I do not have a gallbladder, fatique

Got anaphylaxis 24 hours later; This is a spontaneous report from a contactable consumer (patient). A 34-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot Number: EW0164) via an unspecified route of administration administered in left arm on 20Apr2021 at 14:15 (at 34 years old) as single dose for COVID-19 immunization. There were no other vaccinations within 4 weeks prior to the first dose of BNT162B2. Medical history included mast cell activation disorder from unspecified date. "Known allergies: with mast cell disorders possible everything and nothing" (as reported). The patient's concomitant medications were not reported. The patient did not have COVID prior to vaccination. The patient was not tested for COVID post vaccination. The patient got anaphylaxis about 24 hours later, which was considered serious medically significant on 21Apr2021 at 03:00 requiring emergency room visit. The patient reported he had mast cell activation disorder and got anaphylaxis about 24 hours later. The patient suspected to have more than one tryptase alpha/beta 1 (TPSAB1) gene need genetic testing to confirm thus more hemagglutinin receptors that the spike protein attached to. Outcome of the event was unknown.

anaphylactic reaction; about to black out/lost consciousness; cold sweats; had a hard time /trouble swallowing; turning pale; his pupils were dilated; This is a spontaneous report from a contactable Pharmacist via Medical Information. This Pharmacist reported for two patients, this is the first of two reports regards to a male patient. A 34-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via intramuscular, administered in left arm on 02Jun2021 between 10:00 and 11:00 am, maybe around 10:30ish (Batch/Lot Number: EW0178; Expiration Date: Aug2021, NDC number: 59267100002) as 1ST DOSE 0.3ML, SINGLE for covid-19 immunisation at pharmacy. The patient medical history and concomitant medications were not reported. No prior vaccinations (within 4 weeks). No additional vaccines administered on same date of the Pfizer suspect. A pharmacist from pharmacy had 2 patients who received the vaccine and both had a reaction after the dose, within one hour after receiving the dose, and EMS was called. The pharmacist confirmed the first patient had the reaction within 1 hour of receiving the dose. She clarified this person was having cold sweats, about to black out, had a hard time and trouble swallowing and was turning pale, his pupils were dilated. Pharmacist explained they make them sit there for 15 minutes after receiving the vaccine so this reaction happened maybe 3 minutes after he got the shot. The EMS came and he was brought to the hospital. The patient did come back afterwards and he said the doctor didn't know 100 percent what happened, but it might been a slight allergic reaction, not to the point where he lost consciousness, but they did release him. She clarified they checked his vitals and everything and released him. When pharmacist was probed for the event, the pharmacist thought it was an anaphylactic reaction. The events require a visit to Emergency Room, patient was brought by EMS. Not had a visit to Physician Office. Unknown if patient received treatment, the pharmacist wasn't be told that much information. The outcome of events was unknown. Causality: In this case, pharmacist did not think so. She thinks maybe it was anxiety but she wouldn't know.; Sender's Comments: Based on plausible temporal relationship, a possible causal association between the events 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.,Linked Report(s) : US-PFIZER INC-2021646208 same reporter, product, different patient and similar events.

Swollen lymph node in underarm area; This is a spontaneous report from a contactable consumer, the patient. A 34-years-old-male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown,) via an unspecified route of administration in left arm on 14Mar2021 at 12:45 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and concomitant medications. The patient had no allergy to medications, food, or other products. The patient had not received any vaccine within four weeks prior to the COVID-19 vaccine. Prior to vaccination and since the vaccination the patient had not been diagnosed with COVID-19. On 15Mar2021 at 18:00, the patient experienced swollen lymph node in underarm area. The patient had not received any therapeutic measure or treatment taken for the resulted adverse event. The clinical outcome of swollen lymph node was resolving. Information about lot/batch number cannot be obtained. No further information is expected.

First shot gave Severe Edema in the feet and ankles. Went to ER to check it. Second one occurred the same night of the vaccine which is also reported at this but that was on 5/21/21. That gave similar effects to the first one. Following after which legs started to hurt and gave pitting edema. This is not related to high sugars as it happened instantly verses long period of time. Then arms and hands began to get neuropathy as well, continuing to the present.

11Jun21: Fever, body aches. 12Jun21: swelling of lymph nodes. 17Jun21: cyst formation on testicle. Hospitalized due to pain. Given antibiotics and ibuprofen.

Symptoms of generalized ascending paresthesias with right hand weakness since May 18, 2021, first right foot then left, then ascending to the trunk and upper extremities. As of June 21 left with residual right hand weakness and paresthesias. second Covid Pfizer vaccine given May 19, 2021

02/05/2021- After the 15 minute wait, I went to work and ten minutes into drive my left arm became cold, numb, inflamed and swollen, continued for about 2 hours, was radiating toward my fingertips and shoulder. Fever 102.0 for abut 6 hours, no medication needed it subsided. I also had lethargy, body aches. Within 48 hours all side effects subsided.

seizure; unconscious; passed out; stopped breathing; received Pfizer vaccine, first dose 3 days ago, technically I got pneumonia vaccine, PPsV23; lost my sense of taste; I can't smell; I am feeling like a tingling sensation in my hands, like numbness; I am feeling like a tingling sensation in my hands, like numbness; metallic taste; fatigue; coughing up phlegm; hard time getting to sleep; Left arm hurt a lot and hand is swollen; Left arm hurt a lot and hand is swollen; Tightness of Chest; I can breath but it's like I can't get any oxygen; it's like very hard for me to get air; This is a spontaneous report from a contactable consumer (patient). A 34-years-old male patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number: EW0177) via an unspecified route of administration in Arm Left on 25Jun2021 15:30 as DOSE 1, SINGLE for covid-19 immunisation. Medical history included covid-19 from 2019 to an unknown date doctors believe I had Covid-19 in 2019, neoplasm malignant from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The first dose of the Pfizer vaccine was on 25Jun2021, I have got this kind, out of order. So, he said from what he remembers that he was fine following the vaccination, and everything was good but he took a few steps and collapsed. He started having a seizure and he said, my mom said, you stopped breathing, I was unconscious, tightness of chest I can breathe but it's like I cannot get any oxygen it's like very hard for me to get air. He says, the doctors there, the doctors, he says don't get me started on the (sentence incomplete) and he went to the hospital and was there for like 5 hours and they gave him 5 mg of Valium treatment and he said that was it. They could not find his vein, they did an ultrasound, I guess to find his vein and apparently, he had a couple of seizures. He says, I don't recall, all I remember is waking up in a hospital and I received the Pfizer vaccine first dose and then he said, 3 days ago, technically, I got Pneumonia vaccine which he said he received the PPSV23 vaccine prior the same day of his Pfizer vaccine. Also, he says, I hate needles, so I got tortured. I had the pneumonia vaccine (PPSV23 vaccine) first, he was with his mom, they went out for a while and then went back to where he got the Pfizer vaccine following that (PPSV23 Vaccine). He said, he was there after the Pfizer vaccine for about 30 minutes, got up and had a seizure and he says, that also his mom said that he cannot remember anything because he was unconscious, and they took him to the hospital. Also, he said, he lost his sense of taste, I cannot smell, he said, he was feeling like tingling sensation in his hands like numbness and left arm hurt a lot and hand was swollen. In 2019, he says, he got sick with respiratory issues. He was not sure if he had Covid because they did not know about Covid at that time when he was in the hospital then (consumer had respiratory issues before getting the vaccine, hence not captured as event). He said, it was freaking him out and he was scared to take the second shot. He said, he does not know if this was the combination of getting two vaccination and he says, he used to have cancer (not clarified further, hence not captured as event) and then he says, that they did blood work, it was been followed by the place and they did not tell me anything about the blood work. He says, should I be considered or concerned about getting the second dose of the vaccine because I am experiencing various symptoms and what can I do about my side effects because he is still experiencing metallic taste, loss of smell, fatigue, coughing of Phlegm, having a hard time getting to sleep. Then he says, I forgot to mention, I could feel my heartbeat and I have a cough, I have had a cough from very long time when doctors believe I had Covid-19 in 2019 (further clarification unknown). He wanted to know how safe the vaccine was. Therapeutic measures were taken as a result of seizure, unconscious, passed out. The outcome of the events was unknown. Information on Lot/Batch number was available. Additional information has been requested.

Uticaria and Edema starting at the beginning of May 2021 concurrently. Feet swelling. Hives appearing on torso, arms and legs ER visit for face and eyes swelling.

24 hours after vaccination - compressed breathing, extreme shortness of breath, swollen chest and difficulty speaking or catching air. Extreme headache, fatigue and continuous projectile vomiting. Also experienced irregular heartbeat and increased heart rate. Hands and feet were swollen, red, itchy, hot to touch and joints were stiffened to the point where I couldn't walk or grip. After 48 hours the fever and vomiting were omitted from the symptoms. For the last 2 weeks the chest pain, heart irregularities, swelling of hands and feet and chronic inflammation, fatigue, etc. have continued.

RN administered Epi pen at 1059 r/t PT demonstrating difficulty swallowing/anaphylatic reaction. Rapid Response was called. PT stated he was feeling better as demonstrated by breathing and swallowing without difficulty, pulse WNL. PT was taken to the ED by RR Team for further assessment/observation. Was DC'd from ED after reassured that was feeling fine. Solumedrol adn benadryl given in ED. DC'd with epipen, benadryl, prednisone, and famotidine.

Severe FUO illness with temp > 103 for 4-5 weeks duration after 10 days of receipt of COVID vaccine. had developed pharyngitis symptoms, night sweats. work up negative for other etiologies.

pain spreading through his body, arm, should, elbow, it gets worse when he uses more force like when lifting.; minimum pain at inject site of Left arm; had fever blisters all over on my lower lip; I tried moving the couch and both arms went numb gave out on me; felt like I had internal fever until they showed up; as severe muscle and joint pain; as severe muscle and joint pain; This is a spontaneous report from a contactable consumer (patient). A 34-year-old male patient received first dose of bnt162b2 (BNT162B2, PFIZER-BIOTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in arm left on 25Jun2021 (at the age of 34-year-old) as dose 1, single for COVID-19 immunization. No medical history and concomitant medications were not reported. It was reported that side effects started the same day as vaccine stated it was normal at injection site went on for 2 to 3 days minimum pain at inject site of Left arm. By the 4th day till today it has gotten worse, pain spreading through his body, arm, should, elbow, it got worse when he used more force like when lifting. 2 or 3 days ago (as reported), he started experiencing internal fever, although no temperature had fever blisters all over on his lower lip. they are still there and started 3 days ago, when his joint pain got worse, felt like had internal fever until they showed up. Right now, few hours ago, tried moving the couch and both arms went numb gave out on him. It was also reported that he did not want to go to the emergency room (ER) until he spoke. He wanted to know if this was a severe reaction. The patient explained that he was experiencing severe muscle and joint pain. The outcome of the events was not resolved. Follow-up attempts are possible. Information on lot/batch number can be obtained.

Tender L-sided supraclavicular lymphadenopathy lasting 3 weeks and slowly fading away during this time.

First shot only pain at injection site, headache, muscle soreness; all expected. Second shot same as above but starting 24 hours after vaccine I developed left axillary pain. Able to palpate a lymph node ~1cm. Very painful on palpation. Has not limited activity but still painful. Was difficult to fall asleep 2 nights after vaccine. Now day 2 after vaccine still hurts, maybe incrementally better but taking ibuprofen. Cannot palpate significant lymphadenopathy otherwise. No fever. I am a physician.

About 2 hours after the second dose of the Pfizer vaccine I felt a warm, flushed feeling in my left foot, not unlike stepping in a bucket of warm water. The sensation lasted about 5 seconds and disappeared on its own. Since then, about once per hour I have had the same symptom, with a warm, flushed feeling in my left foot. There is no pain, slight numbness and tingling, but no loss of function or coordination. I can sense that the symptom is about to begin approximately 10 seconds before it starts, because my foot begins to feel swollen. This has occurred about 40-50 times since the injection, and has only gone down slightly in frequency over the past 72 hours, currently it is happening about once every 1.5-2 hours.

Headache, Myalgia, chills, swolen clavicular nodes, left arm soreness Narrative: reports headache was severe

At 5 min after the administration, the rash started on the whole hand where the vaccine was administered, petechiae and his right hand fingers began to swell, then eyes started swelling, back with rash, had vomits. On the second had swelling of the face and dark color on the orbit of the eyes and red and yellow lacerations on the inside of the eye. In addition a lot of pain in the joints without being able to walk.

Started with tingling of the tongue and itchiness of the arms. I took 50mg of Benadryl immediately, but then progressed to hives all over on my, arms, trunk, eyes, ears, and scalp, and legs. Went to the emergency room in case it got worse or obstructed my breathing. In the ER continued to have itching and extreme redness of my arms, with some swelling of my arms as well. About an hour later the Benadryl began working and received prednisone and Pepcid. Stayed in the ER for another hour and my symptoms mostly resolved. Was prescribed 3 days of 40mg prednisone and given an epipen. Have not had issues since then.

Headache, body ache, lethargic. Ended up falling asleep and sleeping for 13 hours. Woke up to extrememly enlarge lymph nodes under left arm that continues 3 days after first seeing it.; Headache, body ache, lethargic. Ended up falling asleep and sleeping for 13 hours. Woke up to extrememly enlarge lymph nodes under left arm that continues 3 days after first seeing it.; Headache, body ache, lethargic. Ended up falling asleep and sleeping for 13 hours. Woke up to extrememly enlarge lymph nodes under left arm that continues 3 days after first seeing it.; Headache, body ache, lethargic. Ended up falling asleep and sleeping for 13 hours. Woke up to extrememly enlarge lymph nodes under left arm that continues 3 days after first seeing it.; Headache, body ache, lethargic. Ended up falling asleep and sleeping for 13 hours. Woke up to extrememly enlarge lymph nodes under left arm that continues 3 days after first seeing it.; This is a spontaneous report from a contactable other health care professional (patient). A 35-year-old male patient of an unspecified age started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number ek5730 expiration date not provided), intramuscular (arm left) first dose on 17Dec2020 13:00 at single dose for covid-19 immunisation. There were no medical history. The patient concomitant medication includes Multivitamin. On 01Jan2021, the patient experienced Headache, body ache, lethargic. Ended up falling asleep and sleeping for 13 hours. Woke up to extremely enlarge lymph nodes under left arm that continues 3 days after first seeing it. No treatment was given for the events. The outcome of the events was recovering. On 07Jan2021 01:15 the patient received second dose intramuscular (arm left) at single dose (lot number EL1283 and expiration date not provided) of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE). Facility where the most recent COVID-19 vaccine was administered in the Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination the patient did not tested positive for COVID-19. Also, patient did not test positive prior vaccination.

For Dose 1, no adverse events other than mild light-headedness and mild joint ache, which began approximately 2 hours after injection and resolved within 24 hours; soreness at the injection site began approximately 6 to 12 hours after injection and persisted for 48 to 72 hours. For Dose 2 (1:15pm), soreness at the injection site began approximately 2 hours after injection (3pm) and was more pronounced than Dose 1. I felt onset of mild fatigue beginning approximately 3 hours post-injection (4pm). Approximately 10 hours post-injection (11pm), onset of fever, chills, muscle ache, and joint ache, was dramatic. I was unable to record my temperature, but felt the fever diminish in intensity approximately 13 hours post-injection (2am). It persisted from this time as muscle aches, joint aches, and sweating intensified throughout the night, and the onset of heart arrhythmia and mild tightness in the chest, as well as a light cough and trouble breathing became a concern. I was unable to sleep and took Tylenol approximately 15 hours post-injection (4am). I took more Tylenol in the morning at approximately 9am, by which time the fever still felt present but low-grade, the muscle and joint aches were still fairly intense, and I noticed that my axillary lymph nodes had swollen to the size of golf balls, with the larger on the same side as the injection. I then took ibuprofen around 1pm. Very mild fever, moderate sweating, cough, muscle aches, joint aches, and heart arrhythmia persisted throughout the day and into the night. All symptoms had not resolved until Friday, Day 3 post-injection.

Facial tingling; facial tingling and numbness/cheek and eye feel swollen or numb; eye feel swollen or numb; eye feel swollen or numb; cheek and eye feel swollen; This is a spontaneous report from a contactable consumer (patient) via Medical information team. A 35-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685), via an unspecified route of administration in left arm on 14Jan2021 09:00 at single dose for COVID-19 immunization. Medical history was reported as none. There were no concomitant medications. The patient received the first dose of the COVID-19 vaccine yesterday morning at 9:00AM. The patient was experiencing facial tingling and numbness on unspecified date. He would like to know if this is a common side effect. He wanted to ask if numbness and tingling in the face a common side effect? The patient does not know if slept on his face or what but his left cheek and eye feel swollen or numb and stated that it was hard to describe. The patient noticed this this morning 15Jan2021. The patient stated, "it sort of feels like when you go to the dentist". The outcome of the event cheek swollen and eye feel swollen or numb was not recovered. The outcome of the remaining events was unknown.

Low-grade fever, injection site pain and swelling, axillary pain and swelling, mild fatigue, mild aches and chills. Treated with 400 mg IBU PRN.

blister; fever; chills; body aches; herpes in his mouth; This is a spontaneous report from a contactable consumer (patient himself). A 35-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685, expiry date not reported), via an unspecified route of administration at the left arm on 19Dec2020 10:00 at single dose for COVID-19 immunisation. Medical history included ongoing Hemophilia A. There were no concomitant medications. The patient was vaccinated at a hospital. The vaccine was not administered at a military facility. The patient stated that he got his first COVID vaccine, but stated that he has hemophilia A and was worried about getting the second dose. The patient reported that two weeks later after getting the vaccine, on 02Jan2021, he had fever, chills, and body aches. He went to the dentist on 02Jan2021 who told him that he had a herpes in his mouth. The patient stated that it was just a blister. All of these effects have gone away completely now and he has recovered completely. The patient stated that he was able to get the fever under control by 06Jan2021. He was not scheduled to get the second dose yet but stated because he worked at the hospital he can go anytime and get it; he just had not gotten it yet because he wanted to ask about the hemophilia A. Clinical outcome of fever was recovered on 06Jan2021, for chills and body aches was recovered on 04Jan2021, for herpes in mouth was recovered on 15Jan2021, while for the blister was unknown.

Local: Mild redness and swelling at injection site 12 hours after injection along with moderate pain at site. Pain began to taper off 36 hours after injection but persists at mild level 69 hours after injection (current). Systemic: Mild chills, muscle, and joint aches 14 hours after injection. Mild fever, moderate chills, and moderate-severe muscle and joint aches 21 hours after injection. Moderate muscle and joint aches continued until 30 hours after injection reducing to occasional mild chills and aches 36 hours after injection persisting through 69 hours after injection (current). Slightly swollen and mildly, at times moderately, painful lymph nodes in neck and near armpit on injection side began 48 hours after injection persisting through 69 hours after injection. Treatment: occasional acetaminophen or ibuprofen (alternating) taken during onset of severe ache pain which reduced to moderate; four doses in total over the course of 24 hour period beginning 14 hours after injection. Mild, moderate, severe categories as described on CDC's reactogenicity page for the pfizer vaccine.

Fatigue and light-headedness in first 12 hours. Body aches, fever, fatigue 12-24 hours. Swollen lymph node in right armpit 24-48 hours.

Chills and swollen throat starting 01/21 @ 2030, went to doctor on 01/27 with no answers. Difficulty swallowing, labored breathing, heart racing, neck pain and right ear plugged up on 01/27 around 2200. Went to ER at 0500 on 01/28. Received steroid shot, ibuprofen, lidocaine gargle. CT scan inconclusive, blood test normal, vitals normal. Prescription for amoxicillin and adavant. Lymph nodes in neck remain swollen to date.

On Thursday following my vaccine, I woke up with fever and chills. Fever was 101 and was relieved with Advil. On Friday, I woke up in the morning and my lymph node under my left arm was swollen like a grapefruit. Was swollen for approximately 4 days.

Received first vaccine on 2/17/21, had left arm soreness and swelling the next day which continued to get worse. Went to urgent care on 2/22/21 diagnosed with vaccine reaction.

Swollen lymph nodes in shoulder and neck on same side as shot. Radiating discomfort into neck, shoulder and arm.

Patient reports that he got the first COVID-19 vaccine on 2/9/2021 By that night some pain in injection site Around noon the next day he got hives everywhere, all over. +itchy They were super raised swollen and everywhere. There was swelling face and neck were starting to get puffy No shortness of breath or inside mouth swelling He took benadryl several times Took over 24 to 48 hours for the hives to resolve

Individual called on 3/11/21 reporting he was diagnosed with shingles on his lower back and significant inguinal lymphadenopathy requirement medical evaluation and ultrasound.

One week following vaccination on left arm, developed left sided neck discomfort and swollen supraclavicular lymph nodes. Persistent 9 days later. no rash/bruising. no other systemic symptoms.

Swelling in my left cheek with a red area on the surface.; Swelling in my left cheek with a red area on the surface.; "skittle" in the flesh of my cheek; still very sore and swollen; This is a spontaneous report from a contactable consumer. A 35-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot_number EN5318) via an unspecified route of administration, in Arm Left on 09Feb2021 10:15 at single dose for covid-19 vaccination. The patient medical history was not reported. Concomitant medication included tizanidine 4 mg ; cannabidiol 10 mg. The patient previously received first single dose of bnt162b2 on 19Jan2021 12:15 PM unknown route left arm single for Covid-19 immunization. Patient previously took Nortriptyline had allergy. the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. other medications the patient received within 2 weeks of vaccination: Tizanidine 4mg, CANNABIDIOL 10mg, adult mens multi-vitamin. On 09Feb2021 16:00, Patient had swelling in my left cheek with a red area on the surface. The area was first noticed when it felt like there was a "skittle" in the flesh of my cheek. It then grew at a slow rate Tuesday evening. During Wednesday it swelled to the size of a large grape before bed last night. This morning the swelling has gone down slightly, but the area is still very sore and swollen. I have sent a message with photos to my doctor and am waiting to hear back if I should go into the clinic or wait to see if the swelling continues to go down. The reporter considered all events was non-seriousness. The patient received treatment was reported as unknown. The outcome of the events was unknown. Prior to vaccination, the patient not diagnosed with COVID-19. Since the vaccination, the patient been not tested for COVID-19.

Client received the Pfizer COVID-19 vaccine and during the post-vaccination wait time he complained of itching around the eyes and face, and felt that his face was swollen. He stated that he had an anaphylactic episode in the past involving peanuts and nut trees, and because of that, he carries an epipen. "911" was called and his vital signs were as follows: BP=173/117; Pulse=76. Engine 205 responded to the call and evaluated the client, but was not transported to the hospital. Client did not receive 2nd dose of the Pfizer vaccine.

Inflammatory arthritis and tendonitis in my left thumb. Isolated swelling and pain to my proximal interpharangeal joint of Left first finger. Symptoms have been persistent since onset. Remain present today. No prior history. No trauma or over use. I am right hand dominant.

Start Date/Time: 8-MAR-2021 11:30 AM/15-JAN-2021 02:00 PM; Start Date/Time: 8-MAR-2021 11:30 AM/15-JAN-2021 02:00 PM; Fever; Arm Pain; Body Aches; Left Under Arm Lymph Node Swelling and Pain; Left Under Arm Lymph Node Swelling and Pain; This is a spontaneous report from a non-contactable consumer (patient). This 35-year-old male patient received dose 2 of BNT162B2 (PFIZER BIONTECH COVID-19 MRNA VACCINE; lot number EL9264) via an unspecified route of administration on 08Mar2021 at 11:30 (at the age of 35-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. The patient had not been diagnosed with COVID-19 prior to vaccination. The patient previously received dose 1 of BNT162B2 (lot number EL9263) on 15Jan2021 at 14:00 (at the age of 34-years-old) as a single dose in the left arm for COVID-19 immunization. On 09Mar2021 after dose 2 of BNT162B2, the patient experienced fever, arm pain, body aches, and left underarm lymph node swelling and pain. The events were reported as non-serious. The patient was not hospitalized for the events. The patient was treated for the events with acetaminophen (TYLENOL) from an unspecified date. The outcomes of fever, arm pain, body aches, and left underarm lymph node swelling and pain were recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19. No follow-up attempts are possible. No further information is expected.

Reactivation of herpes virus a week after the second shot. I had not been diagnosed before this, but my Wife has. I remember having an initial outbreak 12 years ago, but hadn?t had an outbreak since until after getting this vaccine.

left calf pain , swelling and redness, patient reports stating one week prior to being seen in the clinic on 19April2021, Patient was diagnosed with acute Embolism and Thrombosis of left popliteal Vein and started on Eliquis

On Day 1 of second dose 4/21 - Felt weakness and light-headed with slight muscle pain near the site On Day 2 - 4/22 - Severe muscle pain full-body, head ache and low energy On Day 3 0 4/23 - Reduced muscle pain through out body, Head ache consistent, and now developed swollen lymph node on right side with pain felt in right ear and throat when swallowing

Site: Redness at Injection Site-Mild, Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Chills-Severe, Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Fever-Medium, Systemic: Urinated in the event of fainting-Medium, Systemic: Flushed / Sweating-Severe, Systemic: Shakiness-Severe, Systemic: Visual Changes/Disturbances-Severe, Systemic: Weakness-Severe

Pfizer-BioNTech COVID-19 Vaccine EUA: three days after vaccination patient presents to emergency department (ED) reporting sudden onset severe chest pain, emesis, numbness/tingling of arms, and nausea. Initial vital signs: pulse = 90 beats per minute, blood pressure 142/100 mmHg, oxygen saturation 95% on room air. Patient admitted for management of NSTEMI: differential includes myocarditis.

Acute, severe, transient substernal chest pain. Pain lasted 30-45 minutes at a time. Pt. had EKG changes consistent with pericarditis and elevated troponin. Coronary arteries were clear on Left heart catheterization, but patient had EF of 40-45% One recurrence of pain 17 hours after initial onset, otherwise asymptomatic. EKG, TTE, and Cardiac MRI concerning for myopericarditis.

Onset of acute febrile illness 4/23/21 with upper respiratory sx, headache, cervical lymphadenopathy, myalgia. This progressed to severe sx with malaise/lightheadedness, and he was admitted to a local hospital with a diagnosis of septic shock and possible L neck cellulitis. Transferred again to other hospital where he had refractory shock and EF < 15% with global hypkinesis, and finally xferred on 4/28/21 to other hospital. Had PEA arrest in (second hospital) and in transit - resuscitated and placed emergently on ECMO. Overall, picture appears more consistent with viral myocarditis. He has recovered systolic function and is off ECMO and extubated currently.

Roughly 30 minutes after receiving the shot, I developed a small rash on my forearm, on the same arm that I got the shot in. It was not itchy and only slightly raised in a couple spots.

Swollen , painful lymph nodes with reddening at node location. Body aches. Raised heart rate. Headache. Muscle pain. Injection site rash.

Herpes 2 flare-up/outbreak on lower back (belt line) within 2 hours of injection into arm. Flare-ups typically happen 6-18 months. Previous flare-up was 1-2 days after first covid vaccination on 4/21/21.

Epstein Mono virus positive; freezing cold and could not get warm; Heat intolerance; Tongue discoloration; Sore throat; Lost 20 pounds; Swollen lymph nodes; Anxiety causing him to not sleep; constant pressure on his neck; he could barely hear; Trouble swallowing; Breathing was becoming a concern; Anxiety-like symptoms; Pain on right side of neck; Tightness in throat; Right ear plugged; Pretty severe chills; Swollen neck; General fatigue and malaise; General fatigue and malaise; This is a spontaneous report from a contactable consumer (patient). A 35-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 21Jan2021 12:00 (at 35 years old) (Batch/Lot Number: EL9263) as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included ongoing food allergy. The patient's concomitant medications were not reported. After receiving the Covid Vaccine on 21Jan2021, the caller has experienced a lot of adverse side effects that he's dealing with now almost 3 and a half months later. He has seen numerous doctors as well as specialists. He has a long list of symptoms that occurred at onset. What he is dealing with now is a swollen neck (onset date 21Jan2021), a sore throat (onset date 21Jan2021), tongue discoloration, and just general fatigue (onset date 21Jan2021) and malaise (onset date 21Jan2021). Prior to the shot he was physically healthy. He was running about 20 miles a week. Then he got the shot and his health declined significantly and he is still recovering. When this occurred, caller weighed 165 pounds, and now he weighs 145 pounds. He lost 20 pounds. These events happened after the first dose of the vaccine. He got his vaccine at around noon on 21Jan2021, and by that evening at around 2000 he had a tightness in his throat, felt like his right ear was plugged up, then had pain on the right side of his neck. It all coincided with the same side as the vaccine, which he had in his right arm. He also experienced some pretty severe chills. His throat still feels swollen, probably because of his swollen lymph nodes. Some days it is better and some days it is worse. It is causing constant pressure on his neck. He is not sure if he noticed the swollen lymph nodes the same day as the shot or shortly after.Patient does not currently have neck pain. He should probably mention it started probably a few weeks after the onset of his symptoms. He does not know when it went away. He was getting swollen lymph nodes on his left side as well, and his throat became sore on the left side as well. It went away maybe a few weeks ago. He is not sure when the swollen lymph nodes or the sore throat started. His right ear was plugged and then it affected his left ear and it got plugged up as well. It was to the point where he could barely hear. It was almost like an ear infection when it is completely plugged and there is pressure behind the ear drum. 2 weeks after his right side it started on the left side. It has subsided by this time, but it has not completely gone away, but it is not as bad. Patietnt had the chills for 3 weeks, but they weren't as severe as the first night. He was just freezing cold and could not get warm. After that night he was still having issues feeling warm and had to keep his bedroom at like 80 degrees constantly. It probably continued for about a month. He doesn't have chills now, however it evolved into more of a heat intolerance. Whenever he feels to warm he feels more tired and not well overall. It is really odd. It is more heat intolerance he feels is going on. After the first few months it started then he had the opposite. He had a problem getting warm, then after the first month he didn't tolerate heat too well. He is not sure when the tongue discoloration first started, but he noticed it about a month and a half ago. The general fatigue and malaise started at the beginning with everything else. He did not have the second dose of the vaccine. Caller believes the doctors ran a CBC. He had a complete panel done a few times and nothing concerning presented or stood out to the doctors. They did an ultrasound on the left side of his abdomen to make sure he had no spleen enlargement, and that came back normal. They ran thyroid panels and those came back normal. One thing that came back abnormal that explains more of this but the timing is odd with the vaccine is he came back positive for Mono. He started seeing an ENT specialist, and he believes that getting the vaccine could have caused his immune system to freak out considering his history with allergies. It could have caused the Epstein Mono virus already present to become reactivated. That was kind of his theory on why this could have occurred. All the events caused a visit to Emergency Room. He went to the ER about a week, exactly a week after he had the vaccine that day. He was having trouble swallowing (onset date 28Jan2021) as well as his breathing was becoming a concern (onset date 28Jan2021) for him. He also was just having what felt like anxiety-like symptoms (onset date 28Jan2021), and he has no history of anxiety. If he got the vaccine on 21Jan2021 then this happened around 28Jan2021. He did have another ER visit about a week after that one as well. He started to have severe symptoms similar to the first time he went. He is still having a little bit of an issue swallowing. He attributes that to the swelling in his lymph nodes and neck possibly affecting that. His breathing he does not have problems with so much now. He has more of a constant discomfort in his neck, though it is not affecting his breathing at this point. As far as general anxiety he still has that and it does cause issues. It is causing him to not sleep as a result. His swallowing is better. His breathing was the most severe of the symptoms. Maybe after the first month it began to become less of an issue. He couldn't say exactly when it went away. It probably went away as a result of the swelling subsiding. To be honest he is not sure. Doctors put the caller on numerous medications as well as a medicine that he continued with. He doesn't know if his anxiety is better as a result of the medicine helping or if it would be the same if he went off of it. He is not sure. He has had trouble sleeping since this all began. It has been a little better. It could be a result of the medicine that helped. He is really unsure if he was not on the medicine how it would be. Patient visited a Physician Office for all events.No other vaccinations within four weeks prior to the first administration date of the suspect vaccine. No AE(s) following prior vaccinations. The outcome of the events Throat tightness,Sensation of block in ear,Swallowing difficult,Anxiety, Sleep difficult,Hearing reduced was recovering; chills,Swollen lymph nodes,Neck pain,Sore throat was recovered; Tongue discoloration, heat intolerance,Fatigue,Malaise was not recovered; other events was unknown.

Shingles; swollen lymph nodes; This is a spontaneous report from a non-contactable consumer (Patient). A 35-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 19Feb2021 (Lot Number: EN6201), (age at vaccination 35-year-old) as first dose, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not tested for covid post vaccination. On 23Feb2021, the patient experienced shingles, swollen lymph nodes. Therapeutic measures were taken as a result of shingles, swollen lymph nodes as antiviral (Valtrex). Patient did not experienced covid prior to vaccination. The outcome of events were recovering. No follow-up attempts are possible. No further information is expected.

The lymph nodes along my neck are swollen; This is a spontaneous report from a contactable pharmacist (patient). A 35-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: EL3246) on 11Jan2021 15:00 (at the age of 35-year-old) via an unspecified route of administration, administered in arm left as 2ND DOSE, SINGLE for COVID-19 immunization. Medical history included none. Patient had no allergies. Patient had COVID prior vaccination. Patient's concomitant medications were not reported. Patient has not received any other vaccine in four weeks. Patient did not receive any other medications in two weeks. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: EL0140) on 21Dec2020 15:00 (at the age of 35-year-old) via an unspecified route of administration, administered in arm left as 1ST DOSE, SINGLE for COVID-19 immunization. On 18Jan2021 12:00, the patient's lymph nodes along the neck were swollen. Patient did not receive any treatment for the adverse event. The patient underwent lab tests and procedures which included Nasal swab (PCR): negative on 23Jan2021. Outcome of the event was not recovered. Follow-up attempts are completed. No further information is expected.

Pt had vaccine on 7/8 and had a seizure on 7/13. He was at work and was found with blood on his ear and a mark on his face. He had no memory of the incident. Last seizure was at least 7 months prior.

DX: Myocarditis Onset of S/S 06/02/2021 S/S:Dyspnea on exertion, Fever/chills,Tachypnea Found to have acute basilar ischemic stroke, taken for emergent thrombectomy, but experienced progressive edema and ultimately tonsillar herniation. 35 year old man with medical history notable for likely untreated hypertension and tobacco use disorder who presented with reported fever, confusion, shortness of breath, and facial swelling, initially treated for allergic reaction/angioedema without effect, progressed to respiratory failure, found to have acute basilar ischemic stroke, taken for emergent thrombectomy, but experienced progressive edema and ultimately tonsillar herniation resulting in death. Regarding cardiac picture, patient with abnormal ECG, mildly reduced EF on echo (though could be due to untreated hypertension or to respiratory failure/critical illness), borderline troponin (need to check reference range). ED note initially mentions concern for myocarditis due to vaccine causing heart failure and subsequent respiratory failure, but appears this piece was written prior to MRI showing basilar stroke. Death note has myocarditis listed as a cause of death (among many), though a bit unclear if this was intentionally listed or just reflects a list of all hospital problems. Also had a CT of his head which showed scattered foci of gas within intraorbital soft tissues along with mild proptosis; unclear etiology for this (perhaps a fall with facial injuries prior to arriving at hospital?) Awaiting additional physician notes/imaging reports.

Morning after receiving the second Covid shot started experiencing debilitating head and face pain on the left side, it was tender to touch. After several weeks of the constant pain, I went to see my a doctor. My doctor ordered an MRI and referred me to a neurologist. My neurologist reviewed the MRI and said it was normal. She suggested it may be trigeminal neuralgia and prescribed Carbamazepine 100 Mg Chewable Tablet. I then missed a week of work.

Swollen armpit a day after receiving the 2nd shot.; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 01May2021 at 12:45 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. Medical history included mo. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the right arm on 03Apr2021 at 12:45 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 02May2021, the patient experienced a swollen armpit a day after he received the second shot. The clinical outcome of the event swollen armpit was resolving at the time of this report. No follow-up attempts are needed; information about lot number cannot be obtained.

Severe debilitating chills. Worse than any previous infection experienced. Unable to move. Mildly improved with Motrin. Had low grade 100.3 F fever. Weakness aches lymphadenopathy. Severity of symptoms of reduced from severe to mild in just over 48 hours.

Symptoms began on 01/10/2021 around 3:30-4:00 AM PST. I had body aches for 2 days. I woke up on 01/11/2021 with soreness in my right arm pit. I woke up today, 01/12/2021 and had pain and swelling in my right arm pit. I went to my employer's employee health services and was checked out by a provider. I was told that he didn't see anything, and he minimized my symptoms. He didn't seem like he wanted to evaluate me from the time he walked in the exam room. He told me "what do you want us to do? It looks normal." He then went on to tell them he's not going to give me time off for work aside from today. I did not ask for any time off once during the evaluation. I recheck my arm pit when I got home, and noticed the swelling is approx. 3"x 3"s. It was not hard to see when I rechecked. I have noticeable pain the swollen area as well. The swelling is visible when I extend my right arm all the way up above my head. I attempted to tell the employee health provider this, but he preferred to check in a manner that does not show the swelling. I am slightly muscular and when my arm is down, you can only feel soft tissue. Employee health gave me Ibuprofen to treat my Sx's. I called my primary physician's office and am waiting for a call back to be either scheduled for an evaluation or receive medical advice.

I have my armpit swollen; This is a spontaneous report from a contactable consumer (patient). A 36-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number EJ1484), via an unspecified route of administration on 04Jan2021 at SINGLE DOSE for COVID-19 immunization. Medical history and concomitant medications were not reported. It was mentioned that the patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number: EH9899) as COVID-19 immunization and had no secondary effects. It was mentioned that with the second dose that was on 04Jan2021, he had armpit swollen (noted in Jan2021) but it doesn't hurt or anything but its swollen. Outcome of the event was unknown.

Muscle pain; Dizzy; face swelling; Dry heaving; Neck swelling; hip pain, soreness, and his back and shoulders are sore as well, joint achiness; hip pain, soreness, and his back and shoulders are sore as well; hip pain, soreness, and his back and shoulders are sore as well.; brachial plexus origin there was a sharp stabbing pain shooting down; rash was all over his body, but mostly on his back; drowsy; injection sight swelling in his arm; he did kind of feel like something was sitting on his chest; This is a spontaneous report from a contactable consumer. This 36-year-old male consumer received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EK9231), via an unspecified route of administration on 05Jan2021 at single dose for COVID-19 immunisation. Medical history included pre-existing back injury that caused neuropathy, damaged nerves, and chronic sciatica, all in 2009. There were no concomitant medications. On 05Jan2021, the consumer experienced muscle pain, joint achiness which got painful. He was dizzy. His girlfriend noticed a rash on his body. It was welted, but not itchy. His face and neck swelled up. He was dry heaving and couldn't throw up. He was given diphenhydramine hydrochloride (BENADRYL) and steroid shots in the ER. About 4.5 hours after the vaccine, the same day was when it all came on. At 8 o'clock, it got worse. The consumer had hip pain, soreness, and his back and shoulders are sore as well. He was dizzy and drowsy. At 11pm that night, his face was swollen and his neck was swollen. The rash was all over his body, but mostly on his back. He had injection sight swelling in his arm. At his brachial plexus origin there was a sharp stabbing pain shooting down his arm. It did go away. He recovered completely. That stabbing pain lasted from the 5th-6th. He has hip pain, soreness, and his back and shoulders were sore as well. They are ongoing, but improving. He has taken diphenhydramine hydrochloride (BENADRYL) and ibuprofen (MOTRIN). He has not had a fever. His neck still has a little swelling. He didn't have difficulty breathing. But he did kind of feel like something was sitting on his chest. He received a steroid. The consumer had to go to the ER visit. He was there over night from 05Jan2021 to 06Jan2021. The consumer went to get a free COVID test, and they had the vaccine available. The outcome of the event dizzy, face swelling, dry heaving, brachial plexus origin there was a sharp stabbing pain shooting down his arm was recovered on 06Jan2021. The outcome of muscle pain, neck swelling, hip pain, soreness, and his back and shoulders are sore as well, joint achiness was recovering. The outcome of other events was unknown.

On 1/13/21 at about 1100 I felt a swollen lymph node in neck just above the midclavicular line. It is painful and feels hot to the touch. I currently put ice on node.

Large R axillary adenopathy . Present approximately 24 hours. Currently stable. Outcome to be determined.

Swelling of underarm lymph nodes of left arm. First noticed tenderness under arm on post vaccination day 1. Swelling noticeable on day 2 (Friday 1/15/21). Swelling still present as of 1/21/21, though reduced and no longer tender.

High fever (102); chills; lymphadenopathy; headache; This is a spontaneous report from a non-contactable physician. A 36-year-old male patient received the 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK4176 and expiry date: unknown), via an unspecified route of administration on 11Jan2021 07:00 at a single dose for COVID-19 immunization. The 1st dose was received on 21Dec2020 07:00. The patient's medical history and concomitant medications were not reported. The patient experienced high fever (102), chills, lymphadenopathy, headache on 11Jan2021. Outcome of the events was unknown. Patient was not diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. No follow-up attempts are possible. No further information is expected.

Swollen lymph nodes behind collar bone; This is a spontaneous report from a contactable consumer (patient). A 36-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3249), via an unspecified route of administration on 23Jan2021 13:00 at a single dose on right arm for COVID-19 immunization. The patient's medical history was not reported. The patient was not diagnosed with COVID-19 prior to vaccination. No known allergies. Concomitant medications included fish oil, ibuprofen, and niacin. The patient previously received first dose of BNT162B2 on 02Jan2021 at 1:00 PM on right arm (lot number: EK9231) for COVID-19 immunization. No other vaccines received four weeks prior to vaccination. The patient experienced swollen lymph nodes behind collar bone on 24Jan2021 18:00. It was unknown if treatment was received for the event. The patient has not been tested for COVID-19 post vaccination. The patient was recovering from the event.

- Tender, mobile and swollen axillary lymph node (ongoing) - ice and advil seem to help a little - Burning and stinging sensations in the right axilla (ongoing) - ice and avoiding contact between lateral chest and right upper arm seems to help a little - Intermittent paresthesias in the right axilla and chest wall (ongoing)

48 hrs after receiving first dose of Pfizer Covid 19 vaccine I started to feel tension type headaches that were moderate but sometimes can be severe and disabling. These headaches persist daily since the first dose of the vaccine. I still have them today. Duration has been almost two months. No other associated neurologic symptoms at this moment. I dont have any past medical history and never had issues with headaches before. Contacted neurologyst with specialty in headaches for treatment. Labs and MRI without contrast are within normal limits. I used a series of NSAIDS to see if it helped the pain without success. Also did the Botox treatment, which improved headaches but didnt resolve symptoms.

Swelling of forearm by 60%; muscle spasms in pectorial muscle; This is a spontaneous report from a contactable consumer. A 36-years-old male patient received BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine), lot number=EL3247, via an unspecified route of administration in the left arm, on 22Jan2021 at 08:45 (at the age of 36 years-old) as a single dose for COVID-19 immunization. The vaccination was administered at a doctors office/urgent care. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included lisdexamfetamine mesilate (VYVANSE) received within 2 weeks of vaccination. On 23Jan2021 at 0800, the patient experienced swelling of forearm by 60%, and muscle spasms in pectoral muscle. The patient was not hospitalized for the event nor received treatment. The clinical outcome of the events was not recovered. Since the vaccination, the patient has not been tested for COVID-19.

Please reference separately submitted MIS-A form. He had sore throat, high fever, diarrhea, deteriorating in to multisystem failure and apparent acute myocarditis, notably with relative initial sparing of the lungs. He suffered cardiac arrest in radiology after developing aphasia and was transferred to Hospital after cannulation for VA ECMO; he died there 2/8/21.

swollen lymph node in his neck, left side, above the collar bone.; This is a spontaneous report from a non-contactable consumer (patient). A 36-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EN5318), via an unspecified route of administration in left arm on 27Jan2021 at a single dose for COVID-19 immunization. The patient's medical history was not reported. The patient did not have Covid prior vaccination. Concomitant medications included anthrax vaccine (ANTHRAX) in Dec2020. The patient previously received the first dose of BNT162B2 (Lot number EL1284) on 06Jan2021 in left arm. The patient experienced swollen lymph node in his neck, left side, above the collar bone on 30Jan2021 06:00. The patient underwent lab tests and procedures which included Covid-19 RT-PCR test (Nasal Swab): negative on 06Feb2021 post vaccination. No treatment was received for the event. The outcome of the event was not recovered. No follow up attempts are possible. No further information is expected.

Vaccine given 3:50 pm. Facial swollen and rash 30 minutes after injection. Two Benadryl were taken at home. Drove to urgent care for treatment, and they advised to go to ER. Upon arrival to ER, started having chest pain and mouth/tongue were starting to swell (5:30). Was admitted to ER around 5:45. Full work up was done in ER. Was given two albuterol nebulizer treatments, Pepcid, soul-medrol and nitroglycerin ointment. Was admitted at hospital around 12:05 am to a telemetry unit to rule out cardiac etiology. Nuclear stress test read negative for inducible ischemia. Overnight telemetry monitoring revealed no tachyon bradycardia arrhythmias. Patient was discharged on 3/18/2021 and advised to contact Pfizer and CDC in regards to reaction

Pfizer COVID-19 Vaccination Lot # ER8730, Exp: 07/31/21 (Diluent Lot # 6020334, Exp: 11/30/22) given in left Deltoid at 1835, patient observed for 15 minutes then left with wife. Patient called back at 1905, stating that his left hand was swelling up and he was feeling a bit lightheaded. NP returned call at 19:15, and patient was instructed to have his wife drive him to the ER. NP called ER to give report to attending/charge nurse. While NP was still on hold, patient arrived in ER- charge nurse stated that patient was already being seen by a provider when report was given.

4/2/21 Patient calling and states he received the 1st covid vaccine, Pfizer, on the 3-29-21 at 12:07 pm. The patient is having left side rib pain with left axillary pain that travels down the chest. Pain also in the left arm in the injection with shoulder pain all the way down to the elbow. The left hand and the left foot feel cold and tingling. The left sinus cavity feels cold with numbness. The side of the neck feels swollen, unsure. My heart is racing?weakness on the left side of the body. The patient had covid previously. The patient went to ED 4/2/21- diagnosis of Paresthesia of left arm and leg.

The lymph nodes in my left underarm became very enlarged and very sore and painful for 5-6 days. I also had flu like symptoms and severe night sweats while asleep.

About an hour after receiving vaccine I had the following take place: Flush skin, sweating (no fever), stiffened muscles in neck and shoulders, tingling / stiff tounge, and enlarged lymph nodes in neck. Started taking over the counter benadryl (every 4 hours) until I could get in to see my doctor. Flush skin and sweating subsided, but stiffened muscles and swollen lymph nodes persist.

fever, chills, dizziness for the last 2 days, swollen lymph node on left side of neck near collar bone, mild swelling at injection site and itching.

On 1/23/2021 I started feeling nauseas, had headaches, & muscle pain. It lasted all Saturday, all Sunday. On Monday 1/25/2021 I vomited 12 times within 1 hour. I called where I got the vaccine the nurse advise me to go to the ER. I went to the ER I got there with abdominal pain from the vomiting. They said I was dehydrated & they right away started me with IV fluids. They did blood work, abdominal CT scan, & a chest x-ray, My white blood count came back elevated. They said to follow up with my doctor.

Major swelling in both feet, ankles, and calves. Swelling subsided after a few days, but there is still pain in the toes and ankles whenever I sit down

Events: swollen lymph nodes (lymphadenopathy) under arms. lymph nodes are swollen, red, and tender/painful. Painful lymph nodes are uncomfortable when trying to sleep. Some fatigue and tiredness. Low injection site pain. Treatment: None. No pain relievers or NSAIDs Outcomes: swollen lymph nodes increased in pain through the week after the 2nd dose. Lymph nodes remain swollen, but pain seems to be slightly reduced after a week.

Over the days following my first shot on 3-20-2021, I noticed an increased skin sensitivity to irritants including fragrances and lotions that I normally use. Small hives and mild itchiness on the skin began to develop around 4-1-2021. In the days following the second shot on 4-10-2021, the allergic sensitivity to any substance put on the skin became increasingly severe, especially on the left arm where the shot was administered. The left arm became swollen up to 2 times it's normal size by 04-14-2021 even after no more cosmetics or foreign substances were being applied to the skin. Hives appeared on other parts of the body but nowhere as severe as the left arm. The left arm skin was inflamed , itchy and painful. Swelling became so severe that doctors found it necessary to presribe topical and oral steroids (prednisone). Oral steroids were effective at reducing inflammation.

On the 3rd day after shot, swollen lymph node and jaw pain on the same side as injection. Swelling went down after a few days. 8 days after injection, pinched nerve or muscle strain type pain in left side of neck/collarbone and stiff neck and pain. 2 weeks later now, still have pain, it's getting better but has no gone away completely.

Hard clot under the left armpit. Pretty big on the 2nd day after2nd Pfizer COVID19 vaccine on April 17th. Aches if using left hand to push something. On 4/25/2021, clot is getting smaller, however, not disappeared yet. If I squeeze the hard spot/clot, still feel aches. If I squeeze same spot on the right arm, no pain can be felt. I will continue closely monitor by myself to see if it will disappear ultimately.

Looked like he was in sepsis; thrombus occluding his IMV protruding into part of the SMV; Thrombocytopenia; Bacteremia with E. Coli; Unable to tolerate diet; Abdominal pain; Nausea; Vomiting; Muscle aches; Chills; Fever; This is a spontaneous report from a contactable physician. A 36-year-old male patient received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, on 06Apr2021 at 10:00, at the age of 36 years old, for COVID-19 immunization. The patient's medical history included diverticulitis ongoing since 05Nov2018. Concomitant drugs included escitalopram oxalate (LEXAPRO) ongoing since an unspecified date. There were no other vaccinations 4 weeks prior to receiving BNT162b2. Two days after vaccination, on 08Apr2021, the patient developed nausea, vomiting, muscle aches, chills, and fever. The patient continued to have these symptoms and then developed abdominal pain on 11Apr2021, so the patient went to ER. Nausea, vomiting, muscle aches, chills, fever, and abdominal pain were reported as medically significant events. A CT of the abdomen and pelvis was performed on 11Apr2021, which seemed at that time to reveal only uncomplicated diverticulitis. Therefore, the patient was sent home with oral antibiotics. Then, the patient presented back to ER on 14Apr2021: the patient couldn't tolerate his diet and was experiencing worsening of abdominal pain. Another CT of abdomen and pelvis was therefore done on 14Apr2021, which this time revealed a thrombus occluding his IMV protruding into part of the SMV and the portal vein. In light of this finding, on 14Apr2021 the medical staff retroactively looked at the patient's CT scan from 11Apr2021 and they found that the thrombus was already present but less evident than on 14Apr2021. The patient also looked like he was in sepsis, so the medical team was performing a full septic work-up and the patient was hospitalized on 14Apr2021. The patient was terrified, and the medical staff were ruling out acute mesenteric ischemia. On 14Apr2021, blood work showed thrombocytopenia, and a bacteria blood test showed bacteremia with E. Coli. The event thrombus was reported as serious since medically significant, life threatening, and requiring hospitalization. No information regarding seriousness was provided for thrombocytopenia and bacteremia. Treatment with heparin drip was started (ongoing at the time of the reporting) and the patient improved. However, the reporter stated that at the time of the last reporting, all of the patient's symptoms were ongoing, that all of the patient's symptoms had worsened. At the time of the last reporting the patient was in the ICU. The patient had not recovered from the all reported events. The reporter did not know if the reported events were related to BNT162b2, however she added that diverticulitis could also cause all the patient's side effects. Information on the lot/ batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the thrombosis, sepsis and other reported events due to temporal relationship. However, the reported events may possibly represent intercurrent medical conditions in this patient. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including MRI of abdomen and vascular angiogram, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Pt began experiencing pectoralis pain, pectoralis and axillary lymphadenopathy on the same side as vaccine administration.

Swollen underarm and collar bone lymph node; appendicitis; This is a spontaneous report from a contactable consumer reporting for himself. A 36-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EW0161/expiration date: not provided), via an unspecified route of administration, on 31Mar2021 (at the age of 36 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number ER8734/expiration date: not provided), via an unspecified route of administration, on 31Mar2021 at 1:30pm (at the age of 36 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION. Relevant medical history was not provided. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication (other medications taken in two weeks) were none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 22Apr2021 at 3:00pm, the patient experienced swollen underarm and collar bone lymph node and appendicitis. The events required an emergency room visit and the patient was admitted to the hospital. The patient received treatment for these events swollen underarm and collar bone lymph node and appendicitis which included an appendectomy. The outcome of the events swollen underarm and collar bone lymph node and appendicitis was recovering. Since the vaccination, the patient has been tested for COVID-19, test type nasal swab on 24Apr2021 with result negative.

Body aches, low grade head ache, 102 fever, swollen and tender lymph node in left armpit. Lasting over 24hrs

Thrombosis; Vericose veins; Swollen, bulged nerves around left hand palm and fingers/The same symptoms noticed on right foot; Nerves are in black darkened color and the palm fingers, knuckle areas; the palm, fingers, knuckle areas had moderate pain. The same symptoms noticed on right foot.; the palm, fingers, knuckle areas had moderate pain; sensitive to touch; This is a spontaneous report from a contactable consumer(patient). The 36-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 24Apr2021 14:45 (Lot Number: EN6205) as first dose, single for covid-19 immunization. Medical history included none. He had not known allergies to food or medications, no illlness history. Concomitant medications included minerals nos, vitamins nos (CENTRUM A TO ZINC) adutls vitamin, miconazole nitrate (LOTRIMIN AF ANTIFUNGAL) topical cream. The patient experienced one hour after first dose of vaccine shot at left arm shoulder, he saw swollen, bulged nerves around left hand palm and fingers. Nerves were in black darkened color and the palm, fingers, knuckle areas had moderate pain. The same symptoms noticed on right foot. The affected areas on both palm, fingers, foot area have dark patch areas with moderate pain. After 32 hours, he saw swollen nerve back of left leg thigh area with deep pain. It was sensitive to touch. It looked like thrombosis or vericose veins not sure about it. He reached out to doctor office and they said to wait for another day to see if he can recover. whereas he still have the darkened black nerve with pain in the affected areas. Events occurred on 24Apr2021 16:00 which was resulted in doctor or other healthcare professional office/clinic visit. There was unknown if treatment received. Outcome of events was not recovered. There was no covid prior vaccination and post vaccination.

Pain at injection site began within 30 minutes, peaked second day post injection. Pain under left arm (lymph nodes) began 2 days after injection, continued 4 days after injection. Fatigue peaked one day after injection, significantly lessened 2 days after injection.

Chills, fever, fatigue. Arm is swollen and sore. Legs are sore. Have spent the last two days trying to sleep. Cannot decide if I am hot or cold.

The current adverse even is prolonged pain deep within the injection site, as well as shoulder pain and fatigue in left arm. The pain has persisted for almost a month, and has not subsided. I also experienced a swollen lymphnode under left arm, which lasted about two weeks after the 2nd injection.

4-18-21 woke up with N/V/neck pain and stiffness which subsided over the next couple of days. Patient treated the symptoms with Acetaminophen 1g twice daily as needed. with some relief. 5-3-2021 am Patient was unable to move his neck and was in pain. He went to immediate care center He was given a dose of Solumedrol and a Medrol pack. He was informed that he had swollen lymph nodes in his neck and follow up with his primary

hallucinations; very sick; unable to move/unable to get out of bed; pain throughout my entire body; Vomiting; swelling; lost of appetite for 2 days; This is a spontaneous report from a non-contactable consumer (patient). A 36-year-old male patient received the second dose of BNT162B2 (PFIZER COVID-19 VACCINE, lot number: EW0182), at the age of 36 years old, in left arm on 20May2021 10:15 at single dose for covid-19 immunisation. The patient medical history was none. The patient had no known allergies. The patient was not diagnosed with covid-19 prior to vaccination. The patient did not receive any other medications within 2 weeks of vaccination. The patient previously received the first dose of BNT162B2 (lot number: EW0170), at the age of 36 years old, in left arm on 29Apr2021 10:15 at single dose for covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to vaccination. The patient became very sick, unable to move, unable to get out of bed, incredible pain throughout his entire body, vomiting, swelling, hallucinations and lost of appetite for 2 days on 20May2021 23:00. The patient had not been tested for covid-19 since the vaccination. The treatment for events was unknown. The outcome of events was recovering. No follow-up attempts are possible. No further information is expected.

5/9/21 - Pain on right toe, noticeable when walking and tender to touch. Gait affected. 5/11/21 - Pain worsened to the point of being unable to sleep. Right toe pain sensitive to slightest touch and flex, impairing normal walking. 5/11 - 5/19 - Pain and swelling to right foot persisting, necessitating MD visit. Unable to bear weight to foot. 5/20 - Improvement of symptoms

Was fine before the COVID19 vaccine shot. After 15 minutes of observation, I experienced a runny nose which I was told was fine. About an hour later, I experienced slight swelling under my left eye and cheek. A few minutes after, my throat began to have a scratchy feeling and a slight wheezing which was concerning. As soon as I experienced this feeling, I took one Benadryl immediately. After about a half an hour, the swelling under my eye and cheek gradually went down, my runny nose stopped after a few minutes , and my throat itching stopped after about 15 to 20 minutes. I felt fine afterwards.

At approximately 6pm I experienced chest tightening and pain above my heart. When taking deep breaths the pain became more sharp. The pain lasted about 3 days, gradually decreasing each day. At the time I attributed it to stress, as the day and recently I have experienced stress at work. I did not seek medical attention as it improved over time, and has not returned. I decided to report when hearing about the heart inflammation reports, and this was about 1.5 weeks after my 2nd dose. Symptoms do overlap with stress (what I originally attributed to) and what I have read are symptoms of hear inflammation. My adverse events that followed my 2nd vaccine (minor fever, aches, headaches, swollen lymph nodes, etc) only onset about 20 hours post vaccine, and lingered longer than most people that I know.

swelling was increased and spread; very minor pain in the axial area under the arm of the injection site; some minor swelling in that area; fatigue; Minor pain at the injection site; This is a spontaneous report from a contactable consumer (patient). A 36-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9269 and Expiration Date not reported) via an unspecified route of administration, administered in left arm on 05Feb2021 09:30 (at the age of 36 years old) as dose 2, single for COVID-19 immunisation at workplace clinic. The patient medical history included asthma and patient had no known allergies. The patient concomitant medication in two weeks included fluticasone; salmeterol 113/14 inhaler. The patient historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL0142 and Expiration Date not reported) via an unspecified route of administration, administered in right arm on 15Jan2021 13:00 (at the age of 36 years old) as dose 1, single for COVID-19 immunisation. The patient did not receive other vaccine in four weeks. The patient did not had covid prior to vaccination. The patient was not tested for COVID post vaccination. Reportedly, after receiving the second vaccine at 9:30 am on 05Feb2021, the patient experienced some fatigue in the evening and minor pain at the injection site. Around 05:00 the morning of the 06Feb2021, the patient noted some very minor pain in the axial area under the arm of the injection site that seemed to stem from some minor swelling in that area. On 08Feb2021, the swelling was increased and spread. The patient did not receive treatment for events. The outcome of events was not resolved. Follow-up attempts completed. No further information expected.

I've developed IGE Receptor Antibody. Starts with pain in body, and usually a wide-spread hive outbreak. Daily GI issues, and swelling in face in some instances.

Pt. states received 2nd Phizer 07/07/2021 07/09/2021 Body ache, fatigue after 3 days different parts of the body started to swell (under arm pit, behind ear) Ear pain intense 07/13/2021 Primary visited (continue Ibuprofen) Follow Up 07/15/2021

"PMH htn who c/o n/v/d and flu like symptoms. Patient received first dose of pfizer vaccine 12/23/20 at 3pm. A few hours later started having epigastric pain to his back with numerous episodes of n/v nbnb. +chills and myalgias. Denies having any prior adverse reactions to vaccines. Denies any nsaid or etoh use. Denies any abd surgeries. Took 12mg zofran, about 4mg which were IV w/o relief. Denies any itching or rash or hx pancreatitis or anaphylaxis. +mild sob. "

Around 2am on 1/19/20, developed really bad chills. No fever. Had to use 5 blankets to keep warm and quit from having chills. Tylenol helped too. 1/19/20 during the day, tired and sore all over. Sore under same arm as inject- feels like swollen lymph node. Injection site is red, sore and hot on 1/19 and 1/20.

Pain on axillary region and swelling of ganglia on left supraclavicular region. Pain scale 7/10. Symptoms started 1/19/2021.

Chills, fever Tmax 101.4, body aches, fatigue, headache, began 15hours after injection. Worse the next day, and includes ongoing fever now in the 99s on Tylenol/IBU, sore throat with swollen lymph nodes promimal to tonsils. Began taking Tylenol AM day after injection then added IBU mild control of symptoms. Missing two days of work as a result.

29th Friday January 2021-Body aches, HA, aches-real bad in his bones, runny nose, muscle aches, congestion-no sleep Saturday 310th January-Lymph Noes-rt armpit-enlarged-rt neck nodes swollen also, he felt warm all over Sunday 31st January 2021-Very fatigued, BA, muscle cramps, a little congestion Today 1 February 2021-Body aches, taking motrin for his discomforts Reminded if his symptoms get worst-go to the ER, Go to his PCM also if he gets worse-talk to his supervisor if he needs to take off from work

Lymphangitis of left underarm, swollen out to size of softball; administration date=16Jan2021/ 31Dec2020; This is a spontaneous report from a contactable other HCP(patient). A 37-year-old male patient received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EK4176), via an unspecified route of administration at left arm on 16Jan2021 16:45 at single dose for COVID-19 immunization. Medical history included gastrooesophageal reflux disease(GERD), insomnia. There was no Known allergies. Concomitant medication included zolpidem tartrate (AMBIEN), pantoprazole sodium sesquihydrate (PROTONIX). There was no other vaccine in four weeks. Patient previously first dose BNT162B2(lot number=EK5730) on 31Dec2020, 19:00 at Left arm at single dose for COVID-19 immunization. The patient experienced Lymphangitis of left underarm, swollen out to size of softball on 18Jan2021 10:00, occupational health advised to get seen,went to Emergency room, urgent care recommended paracetamol (TYLENOL)for swelling and no anti-inflammatories that may hinder the immune process. Treatment paracetamol was received. Outcome of the event was recovering. There was no covid tested post vaccination.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported "Lymphangitis of left underarm, swollen out to size of softball" and the administration of COVID 19 vaccine, BNT162B2, based on the reasonable temporal association and lacking alternative explanations. 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 RA, IEC, as appropriate.

Vaccine administered 2/4@1030. Small grape sized lump noted to left armpit 2/5@0800. By noon, lump had increased in size. The lump was the size of the palm of my hand. It is painful to touch. No redness or erythema noted. Taking Tylenol and Motrin

Lightheaded/dizziness; Feeling warm; Uncomfortable tingling sensations that started in my fingers and moved up my arms; Uncomfortable tingling sensations that started in my fingers and moved up my arms; Feeling quite unwell; Strong flu symptoms; Felt very hot/cold; Intense aching; Muscle soreness all over; Inflamed lymph nodes (esp in neck); Some nausea; Internal temp (taken under tongue) was also very low, about 95 degrees; This is a spontaneous report from a contactable consumer (patient). A 37-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3302; Expiration date was not reported) on 20Jan2021 (14:30) at a single dose on the left arm, with route of administration unspecified, for COVID-19 immunization. The patient's medical history was not reported. Concomitant medications included naproxen sodium (ALEVE) and cannabidiol (CBD OIL). On 20Jan2021 (14:45), after the vaccination, the patient became lightheaded/dizziness; had started feeling warm; and had uncomfortable tingling sensations that started in the fingers and moved up to the arms. On 20Jan2021, about an hour or two after the vaccination, the patient had begun feeling quite unwell; had strong flu symptoms; was feeling very hot/cold; had intense aching; muscle soreness all over; inflamed lymph nodes (especially in the neck); some nausea; and internal temperature (taken under the tongue) was very low at about 95 degrees. The patient had received treatment for the reported events; blood pressure was taken; and he was given water. The adverse events had required doctor or other healthcare professional office/clinic visit. The outcome of the events, 'lightheaded/dizziness', 'feeling warm', 'uncomfortable tingling sensations that started in the fingers and moved up to the arms', 'feeling quite unwell', 'strong flu symptoms', 'feeling very hot/cold', 'intense aching', 'muscle soreness all over', 'inflamed lymph nodes (especially in the neck)', 'nausea' and 'internal temperature (taken under the tongue) was very low at about 95 degrees', was recovering. The patient was not diagnosed with COVID-19 prior to vaccination, and had not been tested since the vaccination.

Patient had localized reaction in left deltoid with bruising and swelling and left anterior chest wall swelling. Day 6 after vaccination Patient had new onset of genital warts on day 2 following vaccination

Fever from 100 to 103 for 12 hours, Aches, Swollen Lymph nodes armpit and neck area (2 days), headaches (1day), and chills (1 day)

Second dose of Pfizer vaccine was given 1/10/2021 around 9:30 AM. I woke up at around 6:30 AM on 1/13/2021 feeling well. While I was changing, I noticed a diffuse maculopapular rash on my torso back thighs and upper arms. The rash was very pruritic. I took some Benadryl which did not seem to help the itchiness and made me sleepy. By Thursday, most of the rash on the torso was gone, but the rash had spread more to my forearms, lower legs, feet and hands. There was some mild edema of the hands, I had some mild fatigue, and temperature check was slightly elevated around 99 degrees F. By Friday, most of the rash was gone and I had some remaining itchiness of feet and hands. Saturday I was back to normal.

Swollen lymph node in left arm pit pain 3/10; Swollen lymph node in left arm pit pain 3/10; This is a spontaneous report from a contactable consumer (patient). A 37-year-old male patient received his second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=El9264), via an unspecified route of administration on left arm on 05Feb2021 15:00 (at age of 37 years old) at single dose for COVID-19 immunization. The patient medical history was not reported. There were no concomitant medications. The patient previously received his first dose of BNT162B2 (lot number=El3302) on left arm on 15Jan2021 01:00 PM for COVID-19 immunization. The patient experienced swollen lymph node in left arm pit pain 3/10 on 06Feb2021. The outcome of events was not recovered.

Swollen lymph node right groin started about 6-8 hrs after vaccination. Over next 48 hours below that lymph node down to the right knee increasingly red, swollen rash, pain. ER visit diagnosis Lymphangitis. Treated with IV antibiotics then released 7am 12 March. Treatment with clindamycin(450mg) 3x daily for next 7 days. Rest and elevate leg. 12 hours after treatment began, feeling better not well yet. Swollen lymph node appears to be mostly gone and painful swollen rash has been reduced.

Pt with chest tightness after vaccine with throat itching and fullness. Gave Benadryl IM wth symptoms not getting better with pt looking pale . Gave Epinephrine IM with 911 called . Anaphylaxis like reaction

Received injection at approx. 10:30am. Waited at vaccination site for approx. 30 minutes with no reaction. At approx. 11:10am (40 minutes after injection) I started to feel tightness in my chest and developed moderate wheezing. I immediately took two puffs of my albuterol sulfate HFA inhaler. The wheezing stopped after I used the inhaler. I did not need to use my epi injector but it was definitely anaphylaxis based on prior experience. I did not report this to the vaccination site as I had already left. It is now 12:45pm and I feel fine.

I had a stage 1b malignant melanoma lesion removed from my right shoulder in 2014 and had completed all required follow-up. About a week after receiving the first dose (left arm), I noticed a small marble-sized lump in my right armpit. The lump continued to grow rapidly and I went to the doctor, after a biopsy and scans it was confirmed to be metastatic melanoma, most likely a recurrence from the 2014 melanoma. I received the second dose on 18 February (left arm) and noticed the lump in my right armpit grew much faster and I had a reaction (swollen nodes) in my left armpit as well. The melanoma is limited to my right armpit. We are reporting the event because of the timing of the melanoma recurrence in conjunction with the vaccination and because the National Institutes of Health is investigating the biopsy/pathology of the tumor in the right axilla as there are features they have never seen before in melanoma.

Swelling and pain in the armpit Rec'd warm compress or NSAIDS Lymphadenopathy usually resolves within 10 days; see MD if persists or worsens

Within 10-15 mins of shot patient said he felt dizzy and "couldn't see" lips tingly tongue "feels huge"

The melanoma is limited to my right armpit and the timing of the melanoma recurrence in conjunction with the vaccination; noticed the lump in my right armpit grew much faster and I had a reaction (swollen nodes) in my left armpit as well; This is a spontaneous report from a contactable consumer (patient). A 37-years-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 18Feb2021 (Batch/Lot Number: EN9810) as single dose for covid-19 immunisation. Medical history included stage 1b melanoma from 2014 to an unknown date , skin lesion removal in 2014. The patient's concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 for COVID-19 immunisation on 29Jan2021 13:00 on left arm and experienced small marble-sized lump in right armpit. The patient stated that, "I had a stage 1b malignant melanoma lesion removed from my right shoulder in 2014 and had completed all required follow-up. About a week after receiving the first dose (left arm), I noticed a small marble-sized lump in my right armpit. The lump continued to grow rapidly and I went to the doctor, after a biopsy and scans it was confirmed to be metastatic melanoma, most likely a recurrence from the 2014 melanoma. I received the second dose on 18 February (left arm) and noticed the lump in my right armpit grew much faster and I had a reaction (swollen nodes) in my left armpit as well. The melanoma is limited to my right armpit. We are reporting the event because of the timing of the melanoma recurrence in conjunction with the vaccination and because the (institute name withheld) is investigating the biopsy/pathology of the tumor in the right axilla as there are features they have never seen before in melanoma." The adverse event result in Doctor or other healthcare professional office/clinic visit. Therapeutic measures taken as a result of the events included Immunotherapy. No allergies to medications, food, or other products. 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 did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The outcome of the events was not resolved.

Pt is a 37 year old male that presents to the emergency room with complaints of pretty quick onset of swelling to his bilateral cheeks and upper lip that began just after his COVID vaccine today. He received his COVID vaccine about an hour prior to arrival to ED. He denies any tongue swelling, throat swelling, difficulty swallowing or shortness of breath. He has never had anything like this happen before. Since onset, it does not seem to have gotten worse.

Pfizer 1st dose 3/16/21 (lot # EL 9266) on LD??Pfizer 2nd dose 4/6/21 (lot # ER8729) on LD??On 4/9/21, a 37-year-old male, with a history of Alport syndrome with kidney transplant, presented to urgent care with some left anterior lower leg pains. About 6 months ago, he had a small, pea-sized mobile lump in the area, and it did not bother him. About 3 days ago, that little mass disappeared, and in its place, he had some pain, a slightly larger lump/swelling, and significant tenderness. He said the pain was severe when he put weight on his leg or puts pressure on the lump. It was suspected that he had a ganglion cyst that ruptured, and x-ray of the tibia/fibula was performed to evaluate for any bony abnormality. It was not sure if this is a vaccine related incident. Report for record keeping.

Anaphylaxis; drooling; This is a spontaneous report from a non-contactable health care professional. A 37-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: EP7533, Expiration date: Not reported), via an unspecified route of administration on 08Apr2021 as a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that patient had facial/throat swelling after the 15 min waiting period while driving home. No medical treatment, self-resolved with Benadryl at home, Differential Diagnosis: Anaphylaxis (dyspnea, stridor, drooling, tongue swelling). The patient underwent lab tests and procedures which includes patient Vital parameters results included: BP (138/89), HR (81), O2 (96%) at 11:45 am and BP (141/89), HR (68), O2 (97%) at 12:04.. Treatment included: Antihistamines, Epinephrine and IM steroids. Pre-treatment with Benadryl, Pepcid, and Zyrtec. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. ; Sender's Comments: The event anaphylaxis and drooling was considered related to suspect drug based on strong temporal association and known safety profile of the drug. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.

left-sided enlarged axillary lymph nodes, had a subjective fever which was not measured, chills, body aches, fatigue, left arm soreness, headaches, and some sharp chest pain x1 episode, started 20APR2021 warranting ED visit, mostly resolved other than fatigue and dyspnea on exertion by clinic visit 21APR2021

Pt called on 4/20/21 at 10:20am complaining of face swelling on the left side only mostly under the eyes and part of the cheek since Saturday after getting 1st dose Pfizer Vaccine on 4/16/21. Pt stated using warm and cold compression but swelling did not go away. Advised pt to go to the ED

Rash on back (T4/T5) with some pain and discomfort. Wife (MD) thinks it may be a Zoster infection. Swollen lymph node on right armpit.

Day 1: left arm hurting, headache, dizzy, eyes hurting, tired Day 2: left arm hurting, tired, legs were weak, feeling not well in general Day 3 - day 7: left arm hurting, got a lump under my armpit (it hurts and bothers), I have a tingling sensation (left arm to my finges, my left chest, my left back), I feel like when you apply Bengay (hot and cold), it feels like this freeze sensation where heart goes, I feel like a pinch on my back. I get trouble breathing (like anxiety, but it's not). I feel my arm tingles like when you're on top of it and it's "asleep". I'm super scared because these are "known" effects, but it's been 7 days now. Also, I'm super scared because I've heard second dose is when you actually feel sick... if this is the first one, will it get worse on the second one? is it recommended to get second one?

Hives and Swelling of hands, face and arms. Treatment was an epi pen and 60mg of prednisone to be taken daily for 5 days.

Watering eyes/recurrent eyes watery; Runny nose/recurrent runny nose; Drop in blood pressure; Seasonal allergy; Postural orthostatic tachycardia syndrome; tachycardia syndrome; Psoriasis flare-up/flare off of psoriasis/Psoriasis flare-up/Psoriasis flare-up -Worsened; Scalp swelling/ scalp swelling - Worsened/swollen scalp; Knee swelling; Psoriatic arthritis aggravated/-Worsened/flare off of psoriatic arthritis; Itchy scalp/Itchy scalp -Worsened/Localised itching -Worsened/itch on back, arms, knees; Local swelling / Local swelling -Worsened/swollen back; Scalp pain/Scalp pain Worsened/painful scalp; Pain back/Pain back - worsened/painful back; Painful arm/Painful arm - worsened; Painful knee/Painful knee Worsened; Swollen arm /Swollen arm -worsened; This is a non-interventional study report based on the information received by Pfizer (Mfr Control No. 21K-163-3740568-00) received from a contactable consumer (patient). A 37 yearsold male patient received bnt162b2 (BNT162B2), dose 1 intramuscular on 25Mar2021 (at the age of 37 years old) (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous from 2017 (Batch/Lot number was not reported) to 25Mar2021, at unknown dose weekly[1 in 2 wk] for Moderate to Severe Chronic Plaque Psoriasis . Medical history included non tobacco, abstains from alcohol, Klippel feil syndrome, spinal fusion surgery, seasonal allergy, postural orthostatic tachycardia syndrome from 2017 to an unknown date , blood pressure decreased from 2017 to an unknown date. The patient concomitant medications were not reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The patient experienced psoriatic arthritis aggravated/-worsened/ flare off of psoriatic arthritis (medically significant) on 25Mar2021, postural orthostatic tachycardia syndrome on an unspecified date, tachycardia syndrome on an unspecified date. psoriasis flare up/ Psoriasis flare up -Worsened on 25Mar2021, scalp swelling/ scalp swelling - worsened/ painful scalp on 25Mar2021, knee swelling on 25Mar2021, watering eyes/recurrent eyes watery on an unspecified date, runny nose/recurrent runny nose on an unspecified date, drop in blood pressure on an unspecified date, seasonal allergy on an unspecified date, itchy scalp/itchy scalp -worsened/localised itching -worsened/ itch on back, arms, knees on 25Mar2021, local swelling / local swelling -worsened/ swollen back on 25Mar2021, scalp pain/scalp pain worsened/painful scalp on 25Mar2021, pain back/pain back - worsened/ painful back 25Mar2021, painful arm/painful arm - worsened on 25Mar2021,painful knee/painful knee worsened on 25Mar2021, swollen arm /swollen arm -worsened on 25Mar2021, psoriasis flare-up/psoriasis flare-up -worsened on 25Mar2021. The patient underwent lab tests and procedures which included blood pressure measurement: drop on 2017 blood test: normal o an unspecified date, magnetic resonance imaging: normal on 2018, x-ray: normal on 2008. The action taken in response to the event for adalimumab was permanently withdrawn on 25Mar2021(also reported as dose not changed). The clinical outcome of the event Psoriatic arthritis aggravated, Psoriasis flare-up, Scalp swelling, Knee swelling, Itchy scalp, Local swelling , Scalp pain, Painful arm, Knee pain, Swollen arm, Psoriasis flare-up was not recovered, while Postural orthostatic tachycardia syndrome, tachycardia syndrome, Watering eyes, Runny nose, Drop in blood pressure recovered, and the remaining events was unknown. Causality for Humira (Adalimumab) the reporter's causality for the event(s) of postural orthostatic tachycardia syndrome, swollen scalp, swollen knee, recurrent eyes watery, recurrent runny nose, blood pressure drop, seasonal allergies, itch on scalp, itch on back, arms, knees, swollen back, flare off of psoriasis, flare off of psoriatic arthritis, painful scalp, painful back, painful arms, painful knees, swollen arm and recurrent congestion with humira (adalimumab) was no reasonable possibility. The reporter assessment of the causal relationship of the (enter the event term) with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. Information on the lot/batch number has been requested.; Sender's Comments: Based on the available information, the reported events are attributed to underlying or intercurrent medical conditions which were unlikely related to BNT162B2 vaccine.

syncope episode/ lightheaded after 10 minutes of vaccination, slightly diaphonic, pale, swelling to head. water and crackers for the patient BP 100/55, 55, 100% Feeling better then d/c to home

After almost a week after getting my first shot, I started noticing cold sores in mouth which are still present (Been more than a month now). After my second dose on 4/21/2021, I started seeing weird acne on my nose. Also seeing some acne on my back and some on my stomach. The acne seems to be self healing but causes lot of skin irritation/itching. Also, just one week before 5/17/2021, I started noticing that I have several inflammations/sores under foreskin on my penis and some pus around the back of the penis's head. This is causing excessive itching on my penis and causing discomfort during sleep. I am uncircumcised adult.

Ridiculously tired, exhausted; Swollen lymph node, neck and underarm, in varying sizes; Painful lymph nodes, under arm and neck, lymphadenopathy; This is a spontaneous report from a contactable consumer (patient). A 37-years-old male patient received BNT162B2 (Pfizer-Biontech COVID-19 mRNA vaccine, formulation: solution for injection; Lot Number: ER8737, expiration date: unknown), dose 1 via an unspecified route of administration in arm left on 31Mar2021 at 13:30 as 1st dose, single; dose 2 via an unspecified route of administration in arm right on 28Apr2021 at 13:30 (Lot Number: EW0171) as 2nd dose, single (at the age of 37-years-old) for COVID-19 immunization. Medical history included ongoing smoker (patient stated probably started smoking 10 years ago and describes himself as a mild smoker, clarified as less than a half of pack or so, a day). The patient's concomitant medications were not reported. Patient had no prior vaccination and had no AE following prior vaccinations. Patient had no family history. On 23Apr2021 at 17:00, 2.5 to 3 weeks later, after first dose the patient experienced swollen lymph node, neck and underarm, in varying sizes; painful lymph nodes, under arm and neck, lymphadenopathy and patient was Ridiculously tired, exhausted. Patient reported that he had a lymph node on his neck that was the size of an egg and a cluster, more prominent and was getting larger; lymph node in his armpit was about an inch by an inch, he had a node off to the side of a larger node, that was the size of a nickel, and appeared similar to a marble under his skin. Patient stated that in first week he slept a lot, but then the tiredness may be lessened and still exhausted and takes a random nap. Painful nodes have worsened until 26Apr2021. Caller stated that he had seen multiple doctors, including an Urgent Care, and his sister is a doctor. He went to an ear, nose and throat doctor last week and the doctor was scheduling him for a biopsy of the lymph node, and it was assumed that this was a side effect of the vaccine. Patient went to the emergency room on 28Apr2021 for swollen and painful lymph nodes. Events continued after his second vaccine, on 28Apr2021. The patient underwent lab tests and procedures which included computerised tomogram on 29Apr2021: The largest lymph node, measuring 2.3cm by 3.1 cm. Patient also had blood work. Therapeutic measures were taken as a result of painful lymph nodes, under arm and neck, lymphadenopathy with Advil and Tylenol have been effective, but he can tell when the medication is wearing off, and it was time for the next dose. The outcome of Fatigue was unknown and other events were not recovered. Follow up needed, further information has been requested.

Swollen lymph node, neck and underarm, in varying sizes; Painful lymph nodes, under arm and neck, lymphadenopathy; Ridiculously tired, exhausted; This is a spontaneous report from a contactable consumer (patient). A 37-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection; Lot Number: ER8737, expiration date: unknown), dose 1 via an unspecified route of administration in Arm Left on 31Mar2021 at 13:30 as 1ST DOSE, SINGLE; dose 2 via an unspecified route of administration in Arm Right on 28Apr2021 at 13:30 (Lot Number: EW0171) as 2ND DOSE, SINGLE (at the age of 37-years-old) for COVID-19 immunization. Medical history included ongoing smoker (patient stated probably started smoking 10 years ago and describes himself as a mild smoker, clarified as less than a half of pack or so, a day). The patient's concomitant medications were not reported. Patient had no prior vaccination and had no AE following prior vaccinations. Patient had no family history. On 23Apr2021 at 17:00, 2.5 to 3 weeks later, after first dose the patient experienced swollen lymph node, neck and underarm, in varying sizes; painful lymph nodes, under arm and neck, lymphadenopathy and patient was Ridiculously tired, exhausted. Patient reported that he had a lymph node on his neck that was the size of an egg and a cluster, more prominent and was getting larger; lymph node in his armpit was about an inch by an inch, he had a node off to the side of a larger node, that was the size of a nickel, and appeared similar to a marble under his skin. Patient stated that in first week he slept a lot, but then the tiredness may be lessened and still exhausted and takes a random nap. Painful nodes have worsened until 26Apr2021. Caller stated that he had seen multiple doctors, including an Urgent Care, and his sister is a doctor. He went to an ear, nose and throat doctor last week and the doctor was scheduling him for a biopsy of the lymph node, and it was assumed that this was a side effect of the vaccine. Patient went to the emergency room on 28Apr2021 for swollen and painful lymph nodes. Events continued after his second vaccine, on 28Apr2021. The patient underwent lab tests and procedures which included computerised tomogram on 29Apr2021: The largest lymph node, measuring 2.3cm by 3.1 cm. Patient also had blood work. Therapeutic measures were taken as a result of painful lymph nodes, under arm and neck, lymphadenopathy with Advil and Tylenol have been effective, but he can tell when the medication is wearing off, and it was time for the next dose. The outcome of Fatigue was unknown and other events were not recovered. Follow up needed, further information has been requested.

Systemic: Allergic: Anaphylaxis-Medium, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Severe, Additional Details: He had blurred vision, sweating a lot and dizzeness

I received my second dose of the Pfizer / BioNTech COVID-19 vaccine on Tuesday, May 18, 2021 at 1:53pm EDT. Many of the "typical" or "expected" side effects commenced about 12 hours later, including chills, night sweats, a slight fever (99.5), and headache and lethargy the following day. Nothing was particularly off-putting until the afternoon of Wednesday, May 19, 2021, when I noticed small red spots on my legs and feet. A Google search suggested petechiae and enough cause for me to go to a nearby urgent care clinic. The petechiae were present on both legs and feet (and eventually a few spots on my hands), though a little more pronounced on the left side (with one noteworthy cluster on my left leg). I had no apparent gum bleeding or bruising (maybe one bruise, but the urgent care doctor thought it was there beforehand). The doctor at the urgent care clinic confirmed petechiae and ran stat blood work for return that night. At ~9pm EDT on Wednesday, May 19, 2021, I received a phone call from the urgent care's centralized lab informing me that my platelet count was 2 (10^3/uL) -- dangerously low, with risk of spontaneous bleeding and in the worst case scenario brain hemorrhage -- and my PTT was 55.6 seconds. They told me to report to an emergency room immediately, the nearest of Medical Center. The diagnosis was eventually Immune Thrombocytopenia (ITP). Every physician I've encountered has felt that the occurrence one-day post-vaccination points to the vaccine as the cause. (For what it's worth, I do not think any of the doctors or nurses I encountered had never seen a platelet count so low. Most of them said as much.) My discharge papers officially note as the diagnoses: petechiae, thrombocytopenia, and adverse effect of vaccine. I have included details related to my platelet count, treatment course, and other figures below (and am happy to provide corroborating information where appropriate). The doctors did not run any d-dimers, PF4 HIT ELISA, or fibrinogen tests, and no imaging was performed, presumably because I did not present with any signs of simultaneous clotting (e.g., TTP or VITT). They've also told me that my haptoglobin and hemoglobin levels were normal (see below), which I am told helps support the notion that there was / is no clotting or "red blood cell breakdown." Search terms: decreased platelet count, immune thrombocytopenia, ITP, severely low platelet count, low platelets, petechiae, idiopathic thrombocytopenic purpura, immune thrombocytopenic purpura, vaccine-induced immune thrombocytopenia, vaccine-induced ITP

He got his vaccine, and was okay. The next day was tired, drowsiness and missed a day of work, and was able to work after that. He was supposed to get his 2nd vaccine on 5/21/21 and had to go out of town and was going to get it when he got back. The next day 5/23/21 at 12:00 AM his throat began to swell up and gradually it moved from his throat to his chest area. He went to the ER on 5/23/21 in Hospital and they looked at his throat, gave him a steroid shot and some antibiotics and sent him home. The next morning he drove back to home and continued taking the antibiotics that they prescribed and his throat kept swelling more and more. On Tuesday 5/25 at 1:00 PM he went to the ER and sat there 8 hours without being seen and decided to leave. The next morning 5/26/21 he went to an UC and they sent him to an ER at Hospital and from there he was sent to another ER by ambulance to have emergency throat surgery. He had surgery on 5/27/21 at the Hospital where he had an abscess on the inside of his throat that caused his throat to swell. He had swollen lymph nodes and to release the pressure and fluid in his throat as his neck and chest were swelled up. He was discharged on 5/31/21. He is now recovering from the surgery and getting better. He lost 30# as he was not able to eat and did not have an appetite until he came home and eating a little bit better now. He goes back to his doctor on 6/15/21 to get the stitches removed from his neck.

pt called in about getting second dose saying he had shortness of breath for a week, facial swelling and was concerned about second dose. we had not had this reported to us at an earlier date and pt did not report

Inflamed lymph nodes on the side of the injection site. Took naproxen for swelling and pain. Naproxen helps but lymph nodes will swell if not taking it. I have had a cancer screening and that was clean. The doctor thinks the response to the vaccine may have caused this response. At this point my lymph nodes will swell and hurt and then go normal. This happens a few times a day.

E87.1 - Hypo-osmolality and hyponatremia R65.10 - Systemic inflammatory response syndrome (sirs) of non-infectious origin without acute organ dysfunction D69.6 - Thrombocytopenia, unspecified J18.9 - Atypical pneumonia

Swelling of the lymph node of my left clavicle and the lymph node in my left axillary area. The swelling of the lymph nodes resolved in about 1 week. I had what felt like a build up of fluid around my heart and inflammation of my heart, which I believe to have been pericarditis and myocarditis. The heart inflammation resolved in approximately 2 weeks. Flu like symptoms for a 8 hour period about 24 hours after my second vaccination.

Four days following first dose, sudden numbness developed followed by weakness in right leg. Initially attributed to peroneal neuropathy and did not seek medical help. Second dose was received and left foot numbness developed followed by weakness. Symptoms ascended to knees the next few days and was admitted to the hospital. MRI's, x-rays, blood work, lumbar puncture were performed. Treated with 4 days of IVIG. EMG performed to diagnose with Guillain-Barre Syndrome.

In the left arm pit area, where he put deodorant, was painful; He felt pain in his left chest muscle; His left chest felt swollen when he touched it; He had a little pain in his left arm on Saturday, between 2:00PM-3:00PM; This is a spontaneous report from a contactable consumer. A 37-year male consumer (patient) received Bnt162b2 (BNT162B2; Formulation: Solution for injection), dose 2 via unknown route of administration, administered in arm left on 01May2021 as SINGLE DOSE for COVID-19 immunization, and Bnt162b2 (BNT162B2; Formulation: Solution for injection, Lot Number: ER8733) dose 1 Intramuscularly, administered in arm left on 03Apr2021 as SINGLE DOSE for COVID-19 immunization. Patient was 37 years old age at time of vaccination. The patient's medical history was not reported. The patient's concomitant medications were not reported. No emergency room, and physician office visit required. . It was reported that he received his second COVID-19 Vaccine on Saturday, 01May2021, and was still having pain in his (left) arm and (left) chest (muscle). He said his employer told him after 3 days, he had to get a notification from his doctor for why he was sick. He said the clinic he went to said the could not give him the notification his employer was looking for because their clinic didnt provide the COVID-19 Vaccine. He said he had to go back to work tomorrow, and he was not ready to go back to work tomorrow. Caller asked if there was anyway Pfizer could give him a letter to give to his employer for the pain he had in his (left) arm and (left) chest (muscle). Caller was advised that Pfizer was the manufacturer of the COVID-19 Vaccine and did not provide medical advice or services. The caller was offered transferred to Pfizer Medical Information for further assistance. Reporter Type: Stated he worked for Company as a delivery guy, and put together beds. Reported he had a little pain in his left arm on Saturday, between 14:00PM-15:00PM. He said he fell asleep, and woke up on Sunday (02May2021), and his chest felt swollen. He clarified he felt pain in his left chest muscle, and that the pain was all in the left chest muscle and his left armpit. He said he didnt have any pain on the inside, but he could tell the left chest muscle felt swollen when he touched it. He said he really did not have any pain in his left arm anymore, but in the left arm pit area, where he put deodorant, was painful. He said after a couple days his left chest muscle and left armpit were getting better, but he was not ready to go back to work and put hospital beds together. He said on Saturday morning (01May2021) he exercised and did not know if that had anything to do with the pain he was experiencing. Reported he does not have a doctor at this time. Adverse Event (AE) Details: Reported he received his second COVID-19 Vaccine on Saturday, 01May2021, and was still having pain in his left arm, and left chest muscle. He said he had a little pain in his left arm on Saturday, between 14:00PM-15:00PM. He said he fell asleep, and woke up on Sunday (02May2021), and his left chest felt swollen. He said he felt pain in his left chest muscle, and that the pain was all in the left chest muscle and his left armpit. He said he didnt have any pain on the inside, but he could tell the left chest muscle felt swollen when he touched it. He said he really didnt have any pain in his left arm, but in the left arm pit area, where he put deodorant was painful. He said after a couple days his left chest muscle and left armpit were getting better, No follow-up attempts are needed. No further information is expected.

my arm pits were slightly swollen; similar itching sensation and the itching has returned and is limited to my thighs & knees, and forearms & elbow; This is a spontaneous report from a contactable consumer(patient). This consumer reported similar events for two doses. This is the second of two reports, for second dose. A 37-years-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number and expiration date were not reported) via an unspecified route of administration at the left arm on 18May2021 12:30 ( at the age of 37-years-old ) at single dose for covid-19 immunisation. The patient medical history was not reported. the patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included lansoprazole taken for an unspecified indication, start and stop date were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot Number and expiration date were not reported) via an unspecified route of administration at the left arm on 27Apr2021 12:30 (at the age of 37-years-old) at single dose for covid-19 immunisation. After the first dose the patient had an itching sensation in the arms and legs that eventually went away; no rash/hives. The patient previously took omeprazole and experienced allergies to omeprazole. After the second dose on 18May2021 12:45 the patient had a similar itching sensation that also went away, and the arm pits were slightly swollen for a few days afterwards. The itching has returned and is limited to the thighs & knees, and forearms & elbow. No treatment was received for the events. The patient had not been tested for COVID-19 since the vaccination. The outcome of the events was not recovered. The report was reported as non-serious. Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021753984 same patient, same reporter, different dose, similar events

mild fever, chills, fatigue, moderate lower back muscle pain for up to 3 days, inflammed lymph nodes in both armpits.; mild fever, chills, fatigue, moderate lower back muscle pain for up to 3 days, inflammed lymph nodes in both armpits.; mild fever, chills, fatigue, moderate lower back muscle pain for up to 3 days, inflammed lymph nodes in both armpits.; mild fever, chills, fatigue, moderate lower back muscle pain for up to 3 days, inflammed lymph nodes in both armpits.; mild fever, chills, fatigue, moderate lower back muscle pain for up to 3 days, inflammed lymph nodes in both armpits.; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ew0172) via an unspecified route of administration in the left arm on 30Apr2021 at 16:30 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. The patient medical history and past drug history was reported as no. The patient did not receive any other medications within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ew0151) via an unspecified route of administration in the left arm on 09Apr2021 at 10:30 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with 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 vaccination. On 30Apr2021 at 18:00, the patient experienced mild fever, chills, fatigue, moderate lower back muscle pain for up to three days and inflammed lymph nodes in both armpits. The clinical outcome of the events mild fever, chills, fatigue, moderate lower back muscle pain for up to three days was resolved on 03May2021 and of inflammed lymph nodes was not resolved at the time of this report. No follow-up attempts are needed. No further information is expected.

7 hours after vaccine, felt fatigued with muscle aches. 15 hours after vaccine, worsening muscle aches with nausea. 20 hours, peak of muscle pain, nerve pain, nausea, and pressure in eyes. at 20 hours, Tylenol and Benadryl were taken. At 40 hours post vaccine, reaction subsided with new symptom of left axillary lymph node enlargement and tenderness. Axillary lymph nodes normal 72 hours post vaccine.

On 1/14/2020 at 6:00 PM feels face, eyes, mouth, and nose swollen. He took one Benadryl 25 MG, then at 5:00 PM at the moment he feels well. This is notified to the Medical Director.

Fever of 101 for 24 hours, fatigue for 24 hours, left arm lymph node extremely swollen under armpit of injection site arm.

16-40 hours post injection: joint pain/body aches, mid-grade fever, chills, lack of energy, tired. 38+ hours post injection: swelling lymph node in arm pit of arm where injection was administered.

I am a physician myself and would like to report the following adverse event: - 2nd dose of Pfizer COVID 19 vaccine received on 1/8/21 - 1/9/21 Had body aches, chills, no fever, fatigue - relieved with Tylenol and ibuprofen and all resolved by 1/10. - On the night of 1/12/21, after an intense gym workout, I was unable to lay flat in bed. I had sudden onset SOB, chest tightness, audible upper airway wheezing. Symptoms persisted and worsened through the night prompting me to drive to the Emergency Dept.

possible zoster 1 week after getting first COVID vaccine. Cluster of blisters/lesions on left side of scalp and a few on forehead, hyperesthesia, pain, malaise, swollen/painful lymph node behind left ear. No Eye involvement. Treated with Valacyclovir, now resolved.

Anaphylactic reaction (flushing, erythema of skin on arms, chest, and neck, tachycardia, diaphoresis, AMS, weakness); received 0.3mcg epi (Epi-pen) in right thigh after being placed on a litter. EMS contacted. Patient improved prior to EMS arrival and was evacuated for further eval and treatment.

Loss of appetite; Axillary lymph nodes swollen and tender; Axillary lymph nodes swollen and tender; Chills; Headache; Body aches; Nausea; Fatigue; Fever at 102.0; This is a spontaneous report from a contactable nurse (patient). A 38-year-old male patient received the second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: ECL284), via an unspecified route of administration in left arm, on 06Jan2021 at 08:00, at a single dose, for COVID-19 immunization. The patient's medical history included allergies to penicillin (PCN). The patient's concomitant medications included valaciclovir, zinc, ergocalciferol (VIT D), and an unspecified multivitamin. The patient previously took the first dose of BNT162B2 (Lot Number: EH9899) on 16Dec2020 (10 AM in left arm) for COVID-19 immunization. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not administered with other vaccine in four weeks. The COVID-19 vaccine was administered in a hospital. On 06Jan2021 at 08:30 PM (around 12 hours later), the patient experienced chills, headache, body aches, nausea, fatigue, and fever at 102.0. Symptoms went on for three days. Fever after initial fever was low grade fever. At day 3 (09Jan2021), left axillary lymph nodes swollen and tender. Some lingering fatigue and loss of appetite 6 days post vaccine (12Jan2021). No treatment was received for the adverse events. Post-vaccination, the patient has not been tested for COVID-19. At the time of reporting, the patient recovered from the events in Jan2021.

Just a little swoleness under my right arm, possibly lymph nodes. Upper arm at injection site is also sore.

No history of severe allergic reactions. Observed for 15 minutes following vaccine injection. Felt fine at that point so I was told that I could leave. About 10-15 minutes after leaving (about 25-30 minutes after vaccine injection), I started to feel tingling in the bottom half of my face (most noticeable in the bottom lip and chin area), slight swelling on back sides of tongue, and slight swelling of area under chin at the top of the throat (right side only). I could still breathe, drink, and talk normally. Although symptoms did not seem to be intensifying, I decided to seek care at a nearby urgent care out of caution. I arrived at the urgent care about 10 minutes after the onset of symptoms (about 45 minutes after vaccine injection). Provider evaluated me, administered pepcid and a Benadryl shot, and notified me that if I went into anaphylactic shock that they would administer an epipen and call an ambulance. Vitals were normal and remained normal throughout observation. Symptoms began to abate about 15 minutes after Benadryl injection. Tongue swelling abated first about 15 minutes after Benadryl injection. Active tingling in the chin abated about 30 minutes after Benadryl injection, although light numbness remained. Swelling under chin abated about 45 minutes after Benadryl injection. Provider or staff checked on me every 15-20 minutes. Provider released me from observation after about 2 hours. At that point all symptoms had abated with the exception of slight numbness on bottom half of face, which persisted for several more hours.

systematic allergic reaction that is still on going; Exactly two weeks after taking the first shot my body broke out in systematic rash; welts with swelling of face.; welts with swelling of face.; This is a spontaneous report from a contactable Other HCP (patient himself). A 38-year-old male patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Solution for injection, lot no. EH9899, expiration date not reported) intramuscular on left arm on 28Dec2020 at a single dose, then second dose (lot no. EK9231, expiry date not reported), intramuscular on right arm on 18Jan2021 at a single dose for covid-19 immunization. Medical history included known allergies: penicillin. (no major history of allergic reactions except penicillin as a baby). The patient's concomitant medications were not reported. The patient reported that on 11Jan2021 15:00 (03:00 PM) "exactly two weeks after taking the first shot, my body broke out in systematic rash and welts with swelling of face. My doctor thought two weeks was two long of a delay for the reaction to be from the vaccine. My doctor thought it might have been some antibiotics I had been on and they gave me prednisone. The prednisone cleared up the reaction before the second shot. I received the second shot (on 18Jan2021 with lot no. EK9231, intramuscular on right arm) and within two hours I had an even worse systematic allergic reaction that is still on going as of today 04Feb2021. The Prednisone is not clearing up the reaction. I am going to have to take short term disability." The adverse events resulted to patient had clinic visit, disability or permanent damage. Patient took prednisone, famotidine, hydroxyzine, and XANAX (because of the prednisone) as treatments. The vaccine was given in the hospital. No other vaccines were given in four weeks. Outcome of the events was not recovered.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported allergic reaction manifested with "systematic rash and welts with swelling of face" and the administration of the COVID-19 vaccine, BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.

1/8 vaccination Almost 72 hours later, fatigue, itching in a few spots, I saw hives/welts on couple different areas on upper arms, upper thighs. Very big and itchy. I took some Claritin. Those welts continued to grow and spread; Upper inner arms, flanks, inner thighs. Continued throughout the night *took pictures of welts Took some Benadryl at night. Woke up; symptoms still there and extended even more to include hands. I went to work. I wasn't feeling ill but uncomfortable. Took some more antihistamines. It got worse thru the day. No SOB. 1/12 noon Different kind of rash, petechia in appearance.; shins. My knees, ankles, feet were starting to swell. Hives had gone from the thighs and up, But below, shins to feet, were swelling. 1/13 I woke up to a lacy rash over all extremities. Bruising on shins. Knees, hands and feet still swollen. Started Oral steroid. By noon that day, pretty much everything had cleared up. Six day course treatment, no symptoms came back. No fever. No SOB. I did miss work the 1/13 as it was at its worse.

Starting in the evening the day following my vaccinations, my left toe, then foot began to swell and ache. The pain continued to increase over the next 12 hours. I believe I have gout. I will be seeking medical treatment on Monday, March 22.

Around 11pm I had fever and body aches that lasted 2 days and ever since then I have had major fatigue to the point that I cannot be on my feet for more than an hour. The lymph nodes under my right arm are severely swollen.

Fever 101.2, lips, nose and facial swelling; Fever 101.2, lips, nose and facial swelling; nose swelling; Fever 101.2, lips, nose and facial swelling; This 38- year-old male consumer (patient) reported for himself, received the second dose BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE lot EL9264 ), via an unspecified route of administration, on 25Feb2021 at 01:00 PM (at the age of 38-years-old) as a single dose for COVID-19 immunization, in left arm. The facility where COVID-19 vaccine was administered was at a Hospital. She has had no other vaccines in the past 4 weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Historical Vaccine included first dose of BNT162B2 on 04Feb2021 at 1:00PM for COVID-19 immunization, lot number EN5318, in left arm. Medical history and concomitant medications were not reported. The patient had no known allergies. On 26Feb2021, she experienced fever 101.2, lips, nose and facial swelling and was hospitalized 3 days. She went to Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Treatment received included: prednisone, potassium, zyrtex, famotadine. Covid PCR test negative (04Mar2021). The outcome of the events fever 101.2, lips, nose and facial swelling was recovering. It was reported that since the vaccination, the patient had not been tested for COVID-19.

Swollen left foot accompanied by pain Started roughly 10 hours after receiving the vaccine shot. Has persisted for 3 days so far Taking ibuprofen and cold foot bath to control swelling. Difficulty walking

After getting my second shot, the following day4/7/21, I had a 99.5 fever for about 10hrs eventually going away. On Saturday, 4/10/21 I started noticing hive on my upper arms, upper legs and forearms. Took claritan and they disappeared after 4 hours. That night at 9pm they started to show up in different places. In the morning they were on my forearms, knees, body. I took more claritan and went on a 12 mile hike. As I hiked they got worse and then, about 2pm they had disappeared significantly from knees and forearms. Took a shower at the house around 4 and saw hives all along torso, shoulders and upper arms. Took 2 Benadryl?s around 5 and it all seemed to disappear. In the morning, 4/12/21, went to work and saw that hives were only on my hands, and my hands were now swollen too. Perhaps too much sun on my hands, didn?t sunblock them well. Took another Benadryl at 6am, no effect. At work put Benadryl cream on hands, no effect. At noon, took a claritan no effect. Hives never left hands today. At end of day, some hives traveling up forearms. Took a Benadryl and crashed for the night. Hands still have hives and swollen. Palms swollen.

Left armpit lymph-node got Swollen day after the second dose of Pfizer vaccine and continues to stay swollen.

I received the shot on 05Feb. About 4-5 days later I noticed a small bump on my collar bone. On the same side of the shot I received.; This is a spontaneous report from a contactable consumer (self reported). A 38-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch number and expiry date was not reported) via an unspecified route of administration in left arm on 05Feb2021 14:00 as single dose for covid-19 immunisation. Medical history and concomitant medications were not reported. No Known allergies. No other vaccine in four weeks. No other medications in two weeks. No covid prior vaccination. No covid tested post vaccination. On 09Feb2021 at 12:00 am, About 4-5 days later he noticed a small bump on his collar bone on the same side of the shot he received assessed as non-serious. AE resulted in doctor or other healthcare professional office/clinic visit. No treatment received. The outcome of the event was not recovered.

passing out/ passed out; fainted; Vomited all over self; Blood pressure: Low, experiencing hypotension; Lethargy; Pains in legs; Pain in lymph nodes on left side; Migraine headache/ headache; Felt unwell; This is a spontaneous report from a contactable consumer (patient). A 38-year-old male patient received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Lot Number: ER8732, expiration date: 31Jul2021) via an unspecified route of administration, administered on the left arm on 30Mar2021 09:00 at a single dose for COVID-19 immunisation. Medical history included ongoing asthma, thyroid cancer, thyroid removed, rhinitis, allergic to eggs (ongoing). Concomitant medications included calcium since they took out part of parathyroid, levothyroxine for Thyroid removed and calcitriol taken for Better absorption of calcium; and all were ongoing. The patient previously received Tetanus shot on an unspecified date in 2021 (3 weeks to a month prior to getting the first dose of the Covid-19 vaccine) with no adverse events. Patient was calling to report adverse side effects that he experienced 2 days ago on 07Apr2021 after having the first dose of the Pfizer Covid-19 vaccine. He said that on 07Apr2021, he was taken ill in an ambulance after passing out and vomiting all over himself and his wife. His wife may have saved his life by keeping him from falling down when he fainted. He was taken in an ambulance to the emergency room after he passed out. He said that it was an unpleasant experience as he had to strip down all of his clothes because they had vomit all over them and change in front of the paramedics before being placed on a stretcher and taken to the emergency room. While in the emergency room, he had a CT scan, bloodwork, and checked body movement by having him follow a finger and various other regular tests. He mentioned that the emergency room physician determined that in likelihood, the reason that he passed out and vomited on himself was a side effect from the Pfizer vaccination. He talked to his physician yesterday. His physician explained to him that because of his health background, what happened following the first dose of the Covid-19 vaccine, and due to the severity of things, the physician believed that it wouldn't be a good idea for the caller to get the second dose of the Covid-19 vaccine given his reaction. The physician stated that it was up to him whether or not he got the second dose of the Covid-19 vaccine. He had his first dose of the Covid-19 vaccine on 30Mar2021. He began to feel unwell the following day of the Covid-19 vaccine (31Mar2021), experiencing lethargy, pains in his legs and migraine headache. He reported that he got progressively worse and thought he was having a thyroid issue. He reported that the physicians in the emergency room couldn't really determine what the cause of the fainting episode could be as all lab work and the CT scan came back normal. The emergency room physician thought that the caller experienced the fainting episode and vomiting due to the Covid-19 vaccine. He experienced a headache and pain in his lymph nodes on the left side. He took Tylenol and was ok. The next day, 31Mar2021, he didn't feel too well but was ok. He reported that for a few more days following 01Apr2021, he felt not too bad. He didn't have a temperature or a fever and didn't think he was suffering from any specific flu like symptoms. The facility where the vaccine was administered was in a Medical Facility, outpatient hospital like a walk-in center. The event passing out resulted in Emergency room visit. The patient underwent lab tests and procedures on 07Apr2021 which included, potassium levels: normal, blood pressure: low, experiencing hypotension, thyroid levels were normal, CT scan normal and checked for diabetes: negative. Outcome of the events lethargy, pain in legs and migraine headache was recovering, pain in lymph nodes on left side recovered on 31Mar2021 while unknown for the other events.

Tinnitus - significantly increased Brief total failures of hearing in left ear, twice, on the evening of April 21st Swelling in hands - April 26th so swollen was unable to bend right index finger fully Manual dexterity affected - difficulty working with small parts Swelling in ankles and feet - difficulty getting shoes on

Immediately after given the shot my lymph nodes began to swell. I am having difficulty swallowing, eating, speaking, and my salivary glands are creating an enormous amount of spit. I am in a great deal of pain and fatigue. I have taken ibuprofen but it only helps for a couple of hours. It is day 5 since the shot and it does not seem to be going away. If symptoms persist I will not take the second dose of covid.

Rash, starting on lower back and stomach, along with some swelling throughout the body, starting at approximately 8 pm on 4/16. Benedryl (25 mg) was taken at approximately 9 pm. Redness and swelling continued on 4/17, with the redness, swelling, and itching spreading throughout the body. More Benedryl (25 mg) was taken at approximately 6 pm. Symptoms continued, though to a lesser degree on 4/18. Redness and itchiness had disappeared by 4/19, with swelling going away by 4/21.

Developed hives on arms and upper body in the afternoon of 05/03. By evening, I had a rash all over with the exception of hands, feet, and face. Took two benadryl in the evening as well as one Zyrtec. The welts and swelling on arms had subsided by morning (still visible though) but was stronger on legs. Developed swelling in hands and arm overnight as well. Taking more benadryl today and monitoring to see if further treatment is needed.

Patient reported swollen lymph nodes in his throat several days after second shot. It is mild and ongoing, and will follow-up is worsens or doesn't go away.

I noticed, there is like a ball on my armpit, it's swollen and it's painful.; I noticed, there is like a ball on my armpit, it's swollen and it's painful.; I noticed, there is like a ball on my armpit, it's swollen and it's painful.; This is a spontaneous report from a contactable consumer or other non hcp. A 38-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: Unknown) via an unspecified route of administration on an unspecified date (At the age of 38-years-old) as single dose for COVID-19 immunization. The patient medical history was reported as none. The patient's concomitant medication was reported as No, just Vitamins, start and stop dates were unspecified. When probed for the concern, patient stated he received second vaccine, (today is Thursday) on Tuesday patient noticed, there was a ball like on his armpit, it's swollen and it was painful. Patient inquired whether that was normal. Regarding the lot number, the reporter stated that, he took the card home, does not have it with him. Patient stated that there were No Lab test and no Treatment was received. Patient reported he noticed it this morning(as reported), he kind of felt something but this morning it's really swollen. The outcome of the events was reported as an unknown. Information about lot and batch number was requested. Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.

Experienced: 1) left deltoid muscle pain, 2) heightened joint sensitivity in feet, knees, shoulders, and wrists (all bilateral), 3) left underarm lymphadenopathy the size of a fist

Patient reported swelling in his face as well as fever blisters on his body approximately 4 days after his vaccination. Patient reported he went to the ER and received treatment there with steroids and antihistamines, as well as was given a prescription for the same thing to take for a few days after. Event was reported by the ER to the CDC when they were aware, and patient informed us at the site he was vaccinated on 5/20/21 of this reaction

Patient received first dose of Pfizer vaccine and waited 30 minutes after. About 28 minutes later developed itching to forearms and swelling in hands. EMT gave IV Benadryl and patient became dizzy- transported to ED

On day 2 or 3 of getting the shot, I started feeling a burning sensation in my chest and what felt like my heart. It was about 3 or 4 out of 10 on the pain scale. I also had intermittent tingling sensations, mostly on my cheek to the left of my nose, but also tingling in locations around my body which happened only a couple of times. My heart beat rapidly. It was similar to the heart palpitations I get when I eat certain foods. It also felt as if my heart was constrained, as if its outer layers were less flexible than usual. When the symptoms showed up I started following a fairly aggressive anti-inflammatory diet, mainly wheat/cereal and Advil. I spent most of the time lying in bed facing up, in order to minimize strain on my heart. I had trouble laying on my side, since my chest/heart was sensitive to pressure. I also believe I was more acutely aware of the distribution of blood throughout my body, and laying on my side felt similar to being upside down in that blood was pooling heavily at the bottom, but I may be misremembering the sensation. I don't know if I had shortness of breath, since I took care to avoid exertion. Since my heart was beating like crazy, exertion of any kind seemed like a really bad idea. The symptoms did not change in severity for a couple days. On day 4 or 5 of getting the shot, I felt slightly feverish for about a 10 minute period. During this time, I noticed the burning sensation weakening slightly, and I began feeling a soreness on my chest near my left shoulder, which I believe is a lymph node area. Each day after, the symptoms and my heart calmed down little by little. ---- On day 9, I went to the emergency room since I still had heart palpitations and the burning sensation at about a 1/10 pain level. Just sitting upright caused my heart to go into overdrive. The hospital did not find anything out of the ordinary. I was given MAALOX, but the burning sensation was too faint to know if there was any improvement as a result. Their best theory is that I had costochondritis. ---- On day 11, after eating dinner I started getting "chronic hiccups". These last anywhere from 10 minutes to a couple of hours without stopping. I am not sure whether food or drinks cause them. They are short/acute hiccups and happen at an interval of about 10-15 seconds. I have no history of such a thing. ---- Today is day 12. The symptoms are noticeably better since I visited the hospital, but the burning sensation is still present around what feels like my heart and the hiccups aren't stopping. My best theory is that I may have had an infection by the time I got the vaccine. Maybe I had an infection, not necessarily COVID but some related virus, that was kept in check below an immune response threshold until the vaccine came along and led to the immune system burning the whole infection down.

right now what is swollen more and more is at the base of his neck, that lump, on his low throat. Caller states its hurting; right now what is swollen more and more is at the base of his neck, that lump, on his low throat. Caller states its hurting; little lump on the base of his neck where his chest starts; arm was swollen/feels like a swollen tendon; unable to raise his arm because of the pain; pain on the injection site on the arm; dizziness; mild diarrhea; This is a spontaneous report received from contactable consumer (patient). A 38-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number and Expiration Date not reported), via unspecified route on left arm on 22May2021 at 11:00 as for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. On 22May2021, two to three hours after receiving the covid vaccine, the patient had some of the side effects marked on product information such as dizziness mild diarrhea. On 23May2021, the patient had pain on the injection site on the arm, arm was swollen/ felt like a swollen tendon and was unable to raise his arm because of the pain. It was stated it just hurts a little in the area where they put the vaccine, but not like yesterday. On 24May2021, when he woke up, the patient had little lump on the base of his neck where his chest started. It was stated right now what was swollen more and more was at the base of his neck, that lump, on his low throat and stated it was hurting, it was not going away, it just started today. It was also stated that the lump was just persisting, it just hurted when he bended down or presses it, it just hurted. Now he reported that he had a lump in his left bone that goes down from his shoulder to his throat and that felt like a swollen tendon, he also mentioned that he can't lift his arm due to discomfort, he had an appointment with his chiropractor today. The outcome of the events arm was swollen, unable to raise his arm because of the pain, little lump on the base of his neck where his chest starts, pain on the injection site, unable to raise his arm because of the pain on the arm, right now what is swollen more and more is at the base of his neck, that lump, on his low throat and it was hurting was not resolved. The outcome of the events mild diarrhea and dizziness was resolved on 22May2021. Information on the lot/batch number has been requested.

Chest pain, SOB, DOE Pt presented to hospital - transferred to university hospital - underwent LHC which was clean - Troponin rose to 2.23 - ESR, CRP elevated - active chest pain, EKG w/ diffuse ST elevation - myopericarditis - Cardiac MRI - colchicine/ibuprophen - developed NSVT, required beta blockade

After 2nd dose of the vaccine presented swelling of the Rt hand that still continues and also persistent pain on both knees.

4/18/21 pfizer shot in left arm. 8 hours later nausea, heart race, dizzy. go to sleep. wake normal. no more symptoms for 10 days. Day 10, arm pain returns at the injection site. Day 20 arm pain has spread in size and pain, i cancel the second shot. elbow and wrist become inflamed, tight, pain restricted. become sick for 5 days, headaches exhausted. prescribed 40mg prednisone for 5 days. first day it took the swelling down, then swelling came right back 2nd day. pinky and ring finder go numb, paresthesia/paresis. nerve pain in forearm to hand. ulnar nerve at first then all fingers. arm injection pain throbbing. rash shows up on stomach (now at 3.5 to 4 weeks since shot) cannot grasp a cup, weakness and numbness in hand. At this time its confined to the injection arm. Over the next week nerve pain and numbness spread to left side of face, both arms, hands, fingers, legs, feet, toes. physical therapist confirms elbow lymph node on injection arm swelling, hands turning red extreme pain and swelling, loss of feeling. nerve pain in the entire body, nerve and muscle spasms in all parts of body. Fingers and does burning at the tips feel like a string is cutting off circulation. Visibly red. Around the 4 week mark, fully unable to lift legs or arms, left half of face numb, zap/jots seizure like hitting my body. go to ER seemingly becoming paralyzed, within hours strength of legs returns but with numb feet/toes. no diagnosis other than peripheral neuropathy. neck begins to swell, hurts to swallow, throat closing. trying to sleep, throat closed, wake up, completely unable to open throat cant breath. throat episodes lasted about 5 days and resolved. complete insomnia and 24/7tinitus. any attempt to sleep or become tired results in heavy body zaps like hooked to a tenz unit. can't use hands or type, arm to hand seized nerves, feel like shrunken or contracted nerves. PCP prescribes benzos to sleep. this allows some sleep with waking every hour. over the following weeks symptoms seem to improve slowly but still debilitating. today at week 8+ since one shot only, I am able to type again, but with nerve pain and numbness in all fingers. loud tinnitus, numbness in all limbs, episodes of extreme debilitating muscle fatigue come in waves, almost unable to stand agonizing muscle fatigue and nerve zapping. These full body muscle episodes only seem to come in waves of 24 hours, then seem to feel recovering, only to relapse again. injection site pain seems to have wrapped around to the bicep 24/7 pain. unsure if this is nerve or muscle. 3 ER visits, PCP visits, blood tests, no help. I cannot work, constant nerve firing muscle spasms and nerve pain and episodes of weakness so bad you cannot sit without agonizing pain. I am disabled from this and still searching for help

Patient is a very pleasant 38-year-old male with no significant past medical history other than a BMI of 37 and a past history of COVID-19 infection in February 2021 which was asymptomatic with no sequela after he was required to test after his wife tested positive .he is on no medications prior to arrival, he smokes an occasional cigar and drinks alcohol only occasionally who presented to the emergency room on 6/6/21 With a chief complaint of difficulty breathing, fever, malaise and significant left-sided chest pain that have been ongoing since May 23 slowly worsening. He denied any recent travel any recent illness any recent sick contacts. He denied any illicit drug use over-the-counter supplement use .patient reported he received his first Pfizer Covid vaccine on 5/17/2021 and a few days after began to feel congestion with mild coughing which progressed. He initially thought he may be having allergies and took some Claritin without relief. As the week went on he developed increasing shortness of breath and cough and also developed a fever. He went to the well now urgent care on June 3 and was told he may have pulled a muscle and was sent home. He returned back to our emergency room in the early morning of 6/4 complaining of again of left-sided chest pain radiating into his ribs with associated shortness of breath worse with inspiration associated with coughing but no hemoptysis. At that time he had no complaints of fever or chills. He works at a hardware store and thought perhaps he may have strained himself lifting heavy boxes of flooring. During that ER visit he was hypotensive and tachycardic with respirations of 30. CTA of the chest did not show any pulmonary emboli but showed inflammatory changes in the left side in the lingula consistent with possible acute community-acquired pneumonia. He was given Toradol and morphine and was discharged home on oral antibiotics. His EKG at that time showed sinus tachycardia the ST segments were normal. He was afebrile. He returned back to the emergency room the morning of 6/5 with complaints of worsening left-sided chest pain worsening shortness of breath and worsening fatigue. He reported any movement he develops a cough and he cannot lie flat as he develops significant chest pain which is relieved with sitting up. He had been taking some ibuprofen with minimal improvement. He also reported some nausea and fatigue. He had a fever at home of 102 °F just before coming to the hospital but arrived afebrile. Patient admitted to having COVID-19 infection in February when his wife tested positive. He was asymptomatic other than a headache for 1 day and recovered without any incident. In the ER he was again tachycardic but was afebrile. His blood pressure was 137/81 his O2 sat was 97% on room air. He however was quite tachypneic with respirations of 35 at times at rest. Lab work revealed a white blood cell count of 13.2 with significant elevations of his erythrocyte sedimentation rate and CRP at 75 and 20.8 respectively. Covid testing was negative. Repeat chest imaging reveals a large left pleural effusion and atelectasis with no pulmonary edema. CT scan of the chest revealed no pulmonary emboli but now reveals right middle lobe and bibasilar infiltrates suspicious for an infectious or inflammatory process. EKG revealed sinus tachycardia but no ST changes were apparent. Was clinically dehydrated with an elevated specific gravity positive nitrites but 0-9 white blood cells on urinalysis. Troponin at 0-hour was low -3 1 hour was -3 with no change in his delta. BNP was normal at 14 lactic acid was normal at 1.1. Procalcitonin was normal at 0.60 and lipase was normal at 21 with a normal CMP. He was subsequently admitted to the hospitalist service. In the emergency room he was given Rocephin and azithromycin. The following day his condition worsened with continued fever and increasing shortness of breath. . ESR was worsened from 75 to 82 and cardiac crp now >200. A stat echo was ordered and his case was reviewed with the cardiologist. there was concern for possible myo/pericarditis so pt was started on colchicine and ibuprofen tid and the decision was made to transfer the patient to a larger tertiary care facility. stat echo showed normal ef and no sign pericardial effusion. He was transferred to another hospital where he was followed by cardiology and pulmonology. He ultimately underwent thorocentesis but the fluid reaccumulated so a chest tube/drain was placed. He was treated for a peripneumonic effusion. cultures and cytology were ultimately negative. acid fast bacilli was negative, blood cultures were negative. covid 19 pcr testing was negative x 2. He was discharged home on 6/11/2021 with instructions to continue augmentin bid for 4 more weeks with close follow up with pulmonary and repeat chest x ray in 1 month,

The heart rate was 245; A blood clot in the caller's neck; It was thought he might have lymphoma; Felt like he had a golf ball in his left arm/that little golf ball in his arm started traveling to his whole body- his back, his chest, legs, calves; Sweating; Didn't feel too great; Breathing was off/trouble breathing; Throat was hurting/sore throat; Neck was swollen; This is a spontaneous report from a contactable consumer. This consumer (patient) reported for himself that: A 38-year-old male patient received first dose of BNT162B2 (Solution for injection; Lot number: ER8131 or ER8231 and Expiration date were not reported) via an unspecified route of administration, administered in left arm on 18Apr2021 (at the age of 38-year-old) as first dose, single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 18Apr2021, he went to get the Covid shot through name withheld which Pfizer sponsors and it was done at name withheld. He went there and took the shot. He was told to wait 15 minutes and then left. When he got to car, immediately he felt like he had a golf ball in his left arm. The next couple of days, that little golf ball in his arm started traveling to his whole body. He felt it in his back, his chest, he felt it in his legs. Literally, in the next 3 days, he felt it literally travel through his whole body. He felt it in his calves, it was crazy also mentioned they felt sore or like ball in the arm. He started sweating and didn't feel too great. He thought it was standard side effects and didn't think much of it. A couple of days past by and then Thursday morning, he woke up and his breathing was very off. He clarifies his throat was hurting. He thought it was a sore throat and took some cough medicine and cough drops. Then the next day, it wasn't going away and was still hurting, wasn't getting any better. His breathing was very rough. If he was just standing still like laying down, then felt okay. But if went to move or do something it was very difficult. Again, expecting these symptoms, some people have said these symptoms and he didn't' think much of it. The next morning patient woke up and breathing felt fine. His neck was swollen. He thought maybe he had a sore throat or something. He was taking cough drops to soothe his throat the following day, the throat was still hurting, and it was the same. The patient called the doctor and did a telehealth. The patient told the doctor when he received the first dose Pfizer Covid Vaccine and all his symptoms. The doctor said it is a little unpredictable, nothing the doctor hasn't heard. He went to the doctor office the next day and was hooking to a nebulizer for breathing and prescribed an asthma pump. The doctor thought patient had Lymphoma in the neck. The doctor wanted to go the following day for an ultrasound. He went to the ultrasound and they checked the neck and immediately there were red flags. His heart rate was checked, and the heart rate was 245. The patient was hospitalized from 27Apr2021 to 08May2021. The minute they saw heart rate and started putting intravenous and received treatment to low down heart rate. The heart rate went down to 170 or 165. He had x-rays and a CAT scan done. He had fluids in his heart and fluid in the lung and a blood clot in neck. He had a hole cut open on left side to lungs and the lungs were drained. He went back to the ICU, they ran another CAT scan and X-ray and gave the medication. He does not know if this medication was antibiotics or what the medication was. The CDC received this information because the patient case was so rare. When the CAT scan and X-rays were run again, the fluid is right back up in the lungs. Then he was taken to surgery for the heart. An incision was cut from where itches is to back on the side, a very big incision. The heart was gone into to cut a little piece around the heart. Something was cut out so the heart could drain, and fluid could get out of the heart. While all of this is happening, he wasn't getting any better, was getting worse. The patient health deteriorated, breathing was about 10 percent and was hooked up to a breathing machine. He was sedated at that time and not awake anymore. The machine was keeping him alive. Now, every day for basically five days he was asleep and not knowing what was going on and was tested for Leukemia, cancer, and A to Z every disease you can think of to try to find common ground. Everything came back negative; nothing was wrong with the caller. He was given this or that medication every day and was sedated for about 5 days. Every day of the sedation was getting worse. He was dying and time was ticking. On the 5th day, everything was getting worse. The woman kicked everyone out of the room and went into his mouthpiece on the ventilator that was keeping the alive doing the breathing for the patient. The woman pulled something out of his lung. The woman started pumping him with steroids. What the woman took out of his lung stopped the fluid from going in. The fluid wouldn't fill back up in the lung. Once the woman started giving the steroids, the steroids killed the Pfizer Covid Vaccine. The steroids reversed the Pfizer Covid Vaccine. He was started breathing on his own again. After a couple of hours, the patient finally woke up. The patient is now recovered and has been home the past few weeks on a whole bunch of medication. He is on blood thinners, steroids, and stomach stuff. The outcome of the events was unknown. Information on Lot/Batch number was available. Additional information has been requested.

Significant left supraclavicular and cervical lymphadenopathy; Supraclavicular lymphadenopathy; This is a spontaneous report received from a non-contactable physician, the patient. A 38-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in the left arm on 23Jan2021 (at the age of 38-years-old) and a second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 23Feb2021, as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not have any allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with 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 vaccine or any other medication within two weeks of the vaccination. On 06Feb021, the patient experienced significant left supraclavicular and cervical lymphadenopathy. The adverse events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken for the events left supraclavicular and cervical lymphadenopathy which included ultrasound and biopsy. The clinical outcome of the events left supraclavicular and cervical lymphadenopathy was resolved. No follow-up attempts are possible. No further information is expected.

2 days after taking the second dose on my left arm I got a lump under my arm pit; administration_date=21/May/2021; dose_number=1/other_vaccine_same_date_vaccine_d; This is a spontaneous report from a contactable consumer. A 38-year-old male patient reported for himself. This patient reported for himself that a 38-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 vaccine, Formulation: Solution for injection, Batch/Lot number: 59267-1000-1/EW0217), via an unspecified route of administration, administered in Left arm on 21May2021 (38-year-old at the time of vaccination) as dose 2, single and first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 vaccine, Formulation: Solution for injection, Batch/Lot number: 59267-1000-1/EW0183), via unspecified route in right arm on 21May2021 13:30 (38-year-old at the time of vaccination) as dose 1, single for covid-19 immunisation. The COVID-19 vaccine was administered at hospital facility. Patient had no medical history. Patient had no known allergies. Concomitant medication(s) included zolpidem (ZOLPIDEM) 10mg. The patient was not diagnosed with COVID-19 prior to vaccination. The patient not received any other vaccines within 4 weeks prior to the COVID vaccine. On 21May2021, the patient received 2 doses of vaccine on 21May2021 (same date). On 16Jun2021 19:00, after taking the second dose on left arm he got a lump under my arm pit. Patient was not received treatment for events. Since the vaccination, patient has been not tested for COVID-19. The clinical outcome of event 2 days after taking the second dose on her left arm she got a lump under her arm pit was not recovered and other event was unknown. No follow-up attempts are possible. No further information is expected.

My arm is hard, swollen and tender and it's not getting any better; My arm is hard, swollen and tender and it's not getting any better; My arm is hard, swollen and tender and it's not getting any better; This is a spontaneous report received from a contactable consumer or other non hcp (patient). A 38-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: EW0187) via an unspecified route of administration on 17Jun2021 at 16:00 (age at vaccination 38years old) as single dose for covid-19 immunisation. The patient medical history and concomitant medications was not reported. The patient did not take any other medical condition. The patient did not take any other vaccine after covid vaccine. The patient previously received BNT162B2 dose 1 on 27May2021 16:00 AM (at 38 years of age) (Batch/Lot number: EW0185) via unspecified route of administration for COVID-19 immunisation. The patient experienced arm was hard, swollen, and tender and it was not getting any better on 18Jun2021. The patient did not receive any treatment for the events. The clinical outcome of the event was not recovered. Information on Lot/Batch number was available. Additional information has been requested.

Noticed next day (July 3 ) a lump has formed on top of my left shoulder (Bursa Area). 2nd Dose was taken on July 2.

Heart pain worse lying down and on exertion- stayed propped up; Can't think well; Brain fog; Chest pains and discomfort; Chest pains and discomfort/ felt like a elephant on chest; Reduced ability to ambulate due to chest pain; Tachycardia; Had fever (102 f); My arm was more swollen than the time before; The pain was more delayed than the time before/pain over hours spread across my upper back into my right arm and chest and back; Chest back pain worse with movement; Could not stand for two days due to pulse getting even higher standing.; Could not stand for two days due to pulse getting even higher standing.; Entire upper torso hurt.; Felt short of breath/ it hurt to breathe in; it hurt to breathe in; had to use urinals from bed because pulse; This is a spontaneous report from a contactable consumer (patient). A 38-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in left arm on 10Jun2021 15:30 (at age of 38 years old, Lot Number: EW0180) as a single dose for covid-19 immunization. The patient medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included lorazepam, diazepam, paroxetine, bisoprolol. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in right arm on 20May2021 12:15 PM (at age of 38 years old, Lot Number: EW0167) as a single dose for covid-19 immunization. The patient experienced brain fog and chest pains and discomfort, reduced ability to ambulate due to chest pain, tachycardia, had fever (102 f). After receiving the vaccine on 10Jun2021 22:00, the patient arm was more swollen than the time before and the pain was more delayed than the time before. This time the injection pain over hours spread across my upper back into he right arm and chest and back. He had tachycardia and had to increased beta blocker (bisoprolol). Could not stand for two days due to pulse getting even higher standing. Temp of 102. Entire upper torso hurt. Heart pain worse lying down and on exertion-stayed propped up. Chest back pain worse with movement. Felt short of breath. Thought had caught COVID while getting vaccine tested three times, was negative each time. Chest pain and tachycardia slowly improving, but brain fog has been impossible. Can't think well. Having moment of clarity now which was why writing now. It hurt to breathe in, felt like elephant on chest, had to use urinals from bed because pulse. The events result in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Treatment received included Increased bisoprolol dosage for tachycardia. Since the vaccination, the patient had been tested for COVID-19. Nasal Swab, Pixel by on 15Jun2021 was Negative. The outcome of the events " Chest pain and tachycardia" was recovering, for event " Can't think well, Brain fog" was not recovered. The outcome of other events was unknown.

Patient received 2nd dose of Pfizer Covid vaccine on 07-12-21 at 0930. Presented to Health Dept on 07-13-21 and reported that he noticed his left axcillary area was swollen around 0830 on the morning of 07-13-21 approximately 24 hours after receiving 2nd dose of Covid vaccine. Nurse noted that left axcillary area was swollen on the inner area closest to chest and directly in the arm pit area. No erythema present on 07-13-21, was slightly tender to touch. Encouraged to use anti-inflammatory meds, watch area, and to seek medical attention if symptoms persisted or becomes worse.

C/O Right ear pain for about 5 months, intermittently. Does have swollen pre-auricular lymp node. Ear pain and swelling occur since COVID 19 vaccine in January. lasts up to one week at a time, then subsides for about 1 week or more. Pain located in right jaw, right ear canal and up into the right scalp. Pain is aching, not sharp pain. Sometimes throbbing pain. Sometimes right sided headache. Denies photophobia or phonophobia. No history of ear pain or headaches. no swimming. no ear drainage. Denies fevers, chills or night sweats. No weight loss. Feeling of fullness, no hearling loss. Took amoxacillin 1000 mg BID x 2 weeks when symtpoms began several months ago. Then doxycycline 100 mg BID x 2 weeks. No improvemen tin symptoms. Pain not effected by opening or closing mouth. Cleaned ear 1 week prior to MD appointment with a Q tip and there was brownish green liquid on the q tip.

During the week he complianed about chest pain, but we didn't pay any attention. On Saturday morning he was ok, went out and when he cema back he laid down. In the afternoon i woke him up and he had a fever of 102.2, blood pressure 157/96, he was shaking and desoriented. I called 911, in the ER he continue like tat. The doctor did some labs and came out negative, everything they did came out negative, he has seazures the next day and was sent to ICU. He was intubated for 4 days. The doctors said that it was a brain infection but all the test results are negative. The doctors at first thought that it was either menigitis or encephalitis, all the test were negative . His final diagnosis was Sepsis, unspecified organism. He still recovering and does not have any recolection of what happened to him.

experienced swelling of the face and eyes on 24Dec2020. The swelling has progressed since 24Dec2020.; experienced swelling of the face and eyes on 24Dec2020. The swelling has progressed since 24Dec2020.; This is a spontaneous report from a contactable nurse. A 39-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EJ1685, expiry date not reported), via an unspecified route of administration on the left arm at a single dose on 21Dec2020 14:30 for COVID-19 immunization. Medical history was not reported. Concomitant medications included multivitamins (unspecified). The patient experienced swelling of the face and eyes on 24Dec2020 at 22:00. The swelling has progressed since 24Dec2020. No therapeutic measure was taken as a result of the event. Clinical outcome of the events was not recovered. No follow-up attempts are possible. No further information is expected.

Swelling under my armpit.....black and blue....tender to touch...noticeably different than my right armpit in terms of swelling

Painful and enlarged left axillary lymphadenopathy; Painful and enlarged left axillary lymphadenopathy; This is a spontaneous report from a contactable physician. A 39-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number EK5730, via an unspecified route of administration on 21Dec2020 08:15 at a [SINCLE DOSE] and (lot number EK9231),via an unspecified route of administration on 08Jan2021 10:30 at a [SINCLE DOSE] for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously took aspirin (e.c.) and experienced drug hypersensitivity. On 09Jan2021, the patient experienced painful and enlarged left axillary lymphadenopathy. The outcome of the event was not recovered.

Atypical ramsay hunt symdrome on right side. Vertigo started on 7JAN, tinnitus and hearing changes on 8 JAN, vertigo worsening 7-10 JAN, leading to significant headache, nausea and vomiting with complete PO intolerance, leading to ER visit on 13 JAN for fluid rehydration, medications (anti-vertigo, anti-nausea, steroids). CT Head unremarkable, CT soft tissue neck showed lymphadenopathy along with inflammation of right parotid consistent with acute parotitis. CXR normal. Labs relatively normal. Physical exam demonstrated vesicular lesions on right external ear and canal consistent with Ramsay Hunt syndrome. ENT evaluated and concurred. Audiology testing on 13 JAN demonstrated right mild-moderate sensorineural hearing loss. Patient discharged with Valtrex, PO prednisone, antivert.

"Pfizer-BioNTech COVID-19 Vaccine EUA" Pt with hx of herditary angioedema. About 10 minutes after getting vaccine, started to get thirsty. By 30 minutes patient started experiencing numbness and tingling in fingers, then the face, tongue, and lips started to swell. At that time patient took own supply of famotidine 10 mg, diphenhydramine 25 mg, and prednisone 20 mg. Symptoms resolved after about 45 minutes.

Angioedema and hives. Occurred ~50 hr after second dose. Treated with steroid injection at urgent care.

Anaphylaxis of face, neck and lymph nodes. Noted with pictures Fever Nausea Body aches Oxygen levels into the low 90s Dizziness Fatigue Eyes not staying aligned with each other. Noted in pictures

redness, pain to right arm, hive like rash on right side of neck and right cheek 2 days after vaccination without dyspnea, angioedema, other rash location, nausea, lightheadedness. prescribed cetirizine and famotidine

excruciating pain on the left side my face; rash and swelling on the left side of my face; rash and swelling on the left side of my face; swelling of tongue; tingling in the face and tongue; tingling in the face and tongue; This is a spontaneous report from a contactable consumer (patient). A 39-year-old male patient received the first dose of bnt162b2 (BNT162B2, lot number: el3247, expiry date: not reported), via an unspecified route of administration on 18Jan2021 03:45 PM at a single dose on the left arm for COVID-19 immunization. The most recent COVID-19 vaccine was administered at a hospital. 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. Medical history was none. The patient had no known allergies to medications, food, or other products. The patient had no concomitant medications. On 26Jan2021 06:00 AM, the patient experienced "excruciating pain on the left side my face and then noticed a rash and swelling on the left side of my face and swelling of tongue. Also tingling in the face and tongue." Therapeutic measures received as a result of adverse events included prescribed medication. Adverse events resulted into doctor or other healthcare professional office/clinic visit, emergency room/ department or urgent care. Outcome of the events was not recovered. The reporter assessed the events as non-serious. Since the vaccination, the patient has not been tested for COVID-19.

presenting to the emergency department via car for evaluation of Herpes Zoster to the left side of the patient's face. The patient was evaluated at Urgent Care yesterday and sent by the NP. Patient reports three days of rash to the left side of his face with redness and swelling. The patient initially thought the rash was acne due to his face mask. There is intermittent pain to the area which is rated 10/10 severity at its worst. The patient has been unable to sleep the past two days due to the pain. Pain is worse with cold weather and at night with increased clenching of his jaw and grinding of his teeth. He was prescribed Valtrex at Urgent Care and took one dose just PTA to the ED. There is concern given a bump just lateral to the patient's left eye. The patient received his first COVID-19 vaccination on 01/18/2021 and explains that the Urgent Care provider believes this may be an adverse reaction.

Vaccine administered 2021-02-26. Blister cluster formed on right eyebrow near temple on 2021-02-27. Lymph node swelling/tenderness and further inflammation of blister site noted on 2021-02-28. Teledoc called on 2021-03-01, Bactrim DS and Mupirocin 2% ointment for diagnosis of impetigo. In-person appointment with Dr on 2021-03-03 for second opinion. Resulting diagnosis is shingles outbreak near right eye.

Site: Redness at Injection Site-Severe, Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Fainting / Unresponsive-Severe

lymphadenopathy, left armpit. Treated with alternating warm and cold compresses every 30 min, and 400mg Ibuprofen, every 6 hours as needed for pain.

Within an hour of the shot, started feeling dizzy. Intense fatigue and full body aches set in within 3 hours. Facial numbness and left-side facial drooping began within 8 hours. Low fever, chills, heavy heart beat, and intermittent cramps of the abdomen and on the left side (between hip and rib cage) began within 18 hours. Swollen lymph nodes in the neck and constipation began within 48 hours. At ~4 days since the first shot, the facial numbness, heavy heart beat, and fatigue persisted, though the drooping became less prominent and the other symptoms have largely resolved. At ~2 weeks since the first shot, the facial numbness has been constant, but varying in intensity, and the left-side facial drooping has returned multiple times.

The patient fell down on the floor about less than 5 min after vaccinated (while waiting for the 15min observation period), hit his head on the shelf. After turned him over, his eyes were half closed, unconscious, non-responsive and were not breathing properly. Administered an epi-pen 0.3mg, the patient woke up immediately. Also called 911, EMS came and he was able to get up and walk.

left-side facial drooping began within 8 hours; feeling dizzy; ntense fatigue; full body aches; Facial numbness; Low fever; chills; heavy heart beat; intermittent cramps of the abdomen and on the left side (between hip and rib cage); Swollen lymph nodes in the neck; constipation; This is a spontaneous report from a contactable consumer (patient). A 39-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in left arm on 11Mar2021 12:15 (lot number: EN6208) as single dose at the age of 39 years old for COVID-19 immunisation. Medical history included allergies: minor reaction to iodine CT contrast. Concomitant medications included fish oil, turmeric [curcuma longa rhizome] (TURMERIC), and xantofyl (LUTEIN); all taken for an unspecified indication, start and stop date were not reported. The patient previously took iodine and experienced allergies (minor reaction to iodine CT contrast). On 11Mar2021 12:45 PM, within an hour of the shot, the patient started feeling dizzy. Intense fatigue and full body aches set in within 3 hours. Facial numbness and left-side facial drooping began within 8 hours. Low fever, chills, heavy heartbeat, and intermittent cramps of the abdomen and on the left side (between hip and rib cage) began within 18 hours. Swollen lymph nodes in the neck and constipation began within 48 hours. Facial numbness, heavy heartbeat, and fatigue persist, though drooping has become less pronounced and the other symptoms have largely resolved at 100 hours since the first shot. Seeking guidance on whether further medical help should be sought (did nurse line call with insurance company) and whether the booster shot should be administered. The AEs resulted in doctor or other healthcare professional office/clinic visit. No treatment was given for the adverse events. The patient has not been tested for COVID post vaccination. The patient was not diagnosed with COVID prior to vaccination. No other vaccines received four weeks prior to COVID vaccination. Outcome of the events was recovered with sequelae.

A baseball size lump develop under my left armpit 24 hours after my second dose. The lump is still present after 3 days.

Swelling, fever, chills, cough beginning approx 12 hours post vaccine and continuing up to time of report (57 hours post vaccine)

At 1730 same day of vaccine, patient began feeling itching in bottom of feet. Spread to itching arms. At 3am next morning, patient noticed wrists/hands/fingers swelling. 4/14/21 afternoon, reported pain in heels, ball of feet. 4/15/21 reports increased swelling wrists/hands/fingers as well as swelling in forearms, ankle, bottom of feet.

Around Monday the 12th after receiving the vaccine my lymph nodes on the rise side of my head and face were very swollen. The 13th I started to notice bumps on my head, and face. 14th weds felt ill and warm, woke up with a fever. Got tested for covid the morning of the 15th. Went to urgent care that afternoon and was diagnosed with shingles on my face, eyelid, and scalp. Prescribed valtrax for 7 days started the 15th, gabapentin a day later for the pain, 400 mg advil, 1000 mg Tylenol. Lesions are now healing.

Shot administered 4/23/21 at 5:35 PM 4/24/21 - 10 AM - lethargy 4/24/21 - 12 PM - muscle aches and headache and extreme fatigue (lasted throughout day) 4/25/21 - 9 AM - left arm pit lymph node swollen

Left leg DVT. I am a nephrologist practicing in my area. 10 days or so after receiving Pfizer vaccine I started noticing left leg swelling and some redness. I didn't pay attention to it because I thought this could be a muscle or tendon issues because of my exercise. But the swelling did not go away, however, it decreased overtime with leg elevation, etc but when I checked my leg I found out that I have a DVT. I am a healthy 39 ( when I received the vaccine but I am 40 now). I don't smoke. No family history. I am on a blood thinner now. I need to report this as I think that it is important to be reported. I read in the news that a 40 year-old man was diagnosed with DVT after Pfizer vaccine Please call or email if you need further info

Following morning (Thur) after receiving the vaccine, started feeling numbness on my face and swelling. Called my primary care Dr. to report symptoms. She advised I go to urgent care. I went to urgent care and they checked my blood glucose levels, EKG to check my heart was beating correctly. Urgent care advised I go to ER to get further evaluation done. I went to ER where they evaluated me. Advised this is an allergic reaction to the vaccine and to monitor. The following day (Fri) still felt slight swelling/numbness. Symptoms became worse in the evening called nurse line to explain swelling on my lip and face. Advised to take benadryl then go to ER. I went to ER in another location. ER Dr. advised this is an allergic reaction to the vaccine.

Swollen lymph node in left arm pit (the size of a ping pong ball). Fever of 102.5F with chills, headache, joint and muscle ache.

lymph nodes left arm pit swollen and hard tender to touch. Woke up from sleep. Last at least 3 days has gone down but still tender.

Lymph nodes in armpit of injected arm were swolen and painful for 3 days. Pain successfully managed by 400mg Ibuprofen twice per day.

Patient called to report a bump in his armpit on the same arm he received his vaccine on. Patient reports pain only when he presses on the bump, but no issues other than that. RPH told patient to self monitor and call back if symptoms worsen.

Helped someone move their household possessions two days prior to adverse effect, so wasn't sure if related. Observed a burning sensation in upper right pectoral major that moved through right armpit at boundary between biceps brachii and right deltoid. Felt tight during arm movements sway from torso and over head, bringing medium severity burning and tugging sensations under skin. Suspected lymph node irritation from 1st Pfizer shot or damage from moving heavy furniture. After 3-4 days the irritation in right pectoral ceased and burning and tight sensation in deltoid area lessened by approximately 50%. Today as I write this there is little of this persisting - only noticeable in right deltoid area when moving right arm to the most extreme limits of its possible positions, such as above and behind head. This produces a minor burning and tugging sensation in the right deltoid area which encourages slow and careful movement to this extreme position.

blood in stool; muslce pain; a lymph nodes on the left hand side of my neck; This is a spontaneous report from a contactable consumer. A 39-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Left Arm on Apr2021 (vaccine taken at 13:00) (Batch/Lot number was not reported) as SINGLE DOSE (at the age of 39 years) for covid-19 immunisation. Medical history was none. There are no known allergies. The patient did not have COVID prior to vaccination. It is unknown if patient was Covid tested post vaccination. The patient's concomitant medications were not reported. The patient experienced blood in stool (medically significant) on 09Apr2021 01:00 with outcome of not recovered and muscle pain on 09Apr2021 01:00 with outcome of not recovered. The patient noted "a lymph nodes on the left hand side of my neck" on 09Apr2021 01:00 with outcome of not recovered. Therapeutic measures were taken as a result of blood in stool, muslce pain and "a lymph nodes on the left hand side of my neck". The patient was seen in the physicians office. Treatment included pain medication and antibiotics. It was unknown if the patient had any other vaccines in four weeks besides COVID-19 vaccine. Information about lot/batch number has been requested.

Had COVID-19 in July 2019. Afternoon of the second day after my first dose of Pfizer vaccine, developed minor chills/fatigue. Arm soreness persisted for several days, including swollen lymph node in my left armpit.

This is a spontaneous report from a contactable consumer (patient). A 39-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot Number: EL9262), via an unspecified route of administration, administered in arm right on 26 Jan 2021,15:00 at single for COVID-19 immunization (at the age of 39 years). Medical history included known allergies of Pollen, cats. The patient's concomitant medications were not reported. No covid prior to vaccination and no covid tested post vaccination. On 26Jan2021, the patient had severe swelling of arm, fever, headaches and flu like symptoms. No treatment given for all events. Outcome for all events was not recovered. No follow up attempts are possible. No further information is expected.

Patient recently diagnosed with DVT and was taking enoxaparin 80mg subq q12h. Presented to ED after receiving vaccination with increased swelling and redness in RLE. worsening of DVT on imaging.

Pain and burning to back of neck and scalp began on 5.11.2021. Visit to urgent care on 5.14.2021 and prescribed medication for muscle pain (flexeril and motrin) and antibiotic (augmentin) due to enlarged lymph node behind ear and clavicle area. Rash developed to the left side of neck on the evening of 5.15.2021. Returned to Urgent Care on 5.16.2021 and started on Valtrex for shingles. Shingles rash worsened over the following days spreading up on left side of scalp, left side of neck, and down to left shoulder, left side of chest. Rash began to receed on 5.20.2021. On date of report 5.56.2021 slight rash remains to base/back of neck and onto scalp. Pain and burning remain, worsened by pressure/touch and heat.

On 2/17/2021 I received my first dose of Pfizer Vaccination in my left arm. On 2/26/2021, I woke up with a swollen neck and a golf ball sized mass near my lymph node on the left side of my neck. I immediately went to an Urgent Care, who prescribed antibiotics and had an Ultrasound conducted on 3/1/2021, with inconclusive results. On 3/18/2021, I had a MRI of my neck, which resulted in the neck mass being possible malignancy and metastasis (cancer). On 3/28/2021, was admitted to hospital due to neck mass increase in size and symptoms getting worse. CT scan also stated the neck mass as possible malignancy, head and chest were negative. 3/29/2021, hospital conducted an IR biopsy, which resulted in negative for malignancy. 3/30/2021, I was released from hospital. On 4/2/2021, I went to the Emergency Room due to symptoms getting worse. 4/2/2021, had a CT conducted that stated possible malignancy and had a scope of my throat with negative results. On 4/5/2021, hospital conducted an IR Biopsy which resulted negative for malignancy, however favoring inflammation and an abscess. On 4/15/2021, symptoms got worse and fluid was able to be drawn from the neck and sent to the lab, with negative results. On 5/3/2021, surgery was conducted to remove the lymph node and the mass in the neck. Neck Mass was biopsied, was negative for malignancy and negative for infection. On 5/13/2021, hospital Infectious Disease Division, stated the COVID Vaccine could have triggered an immune response, which contributed the issues I was having. On 5/17/2021, Infectious Disease Division conducted more test and blood work for various infections, which all had negative results.

Painful bilateral axillary lymphadenopathy, CBC normal, ESR 43, CRP 7.1, improved quickly with a few days of high dose ibuprofen.

Initially developed a few itchy hives on my right outer calf on 5/13. It became widespread from my knee to my ankle by 5/16. On 5/17 smaller itchy bumps had spread to my stomach and chest and I was evaluated by PCP, who directed me to take Zyrtec and apply Eucerin. By 5/19 smaller itchy bumps had spread to my arms, and my right ankle and foot had started swelling. PCP prescribed a course of antibiotics as a precaution. By 5/21 rash had spread to my back and continued in all other locations. On 5/21 dermatologist prescribed oral steroids (prednisone) and topical triamcinolone. Swelling in leg subsided after a few days. Itching was reduced but still present through to June 1.

This is a 39 year old male presents to clinic for follow up on COVID19 vaccine allergic reaction. Patient received the first dosage in the right deltoid on 12MAR21. About 22 hours later, noticed right-side neck swelling and discomfort. The next day 14MAR21, noticed right ear pain and jaw pain. On 15Mar21, noticed right jaw pain/paresthesia and difficulty opening his mouth. No dyspnea. Went to ER on 15Mar21, observed, treated with Ibuprofen/Tylenol. 3weeks later, he went to the Block arena, was told get the second dose at the Tripler just in case of reaction, that he should be near the ER. Spoke with an Allergist (at the COVID screening tent). He still had some numbness on his jaw. Was told to wait until symptoms clearance before the second shot. Symptoms cleared by 2 weeks later. On 5/21/2021, he went to Covid tent. Was told not to get the second shot. He went to the facility. He seen the medical officer explained the situation. He received the second shot on his right deltoid. He was observed for 30 min and did fine. The next day, he had swelling of the right side of the neck for 4-5 days. Subsided by 5th day. He did not have ear or the jaw pain. Symptoms subsided and he felt normal. No concerns at this point. No chest pain, dyspnea. He can exercise without symptoms.

Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Additional Details: Patient reported throat closure about 9 hours after Pfizer COVID injection. He did not seek medical treatment and it resolved. He called it an anaphylactic reaction. I did not administer the second dose of Pfizer vaccine as a precaution. I told him to seek advice from his doctor and if he chooses to get the second dose, he should get it at a medical facility or doctor's office.

ADVERSE EVENT: BURSITIS OF THE SHOULDER TREATMENT: 4/28/21 CHIROPRACTOR OFFICE VISIT, 5/3/21 CHIRORPACTOR OFFICE VISIT, 5/5/21 CHIROPRACTOR OFFICE VISIT, 5/7 CHIROPRACTOR OFFICE VISIT, 5/8/21 URGENT CARE OFFICE VISIT, 5/14/21 PRIMARY CARE OFFICE VISIT, 5/17/21 CHIROPRACTOR OFFICE VISIT, 5/18/21 ORTHOPEDIC SURGEON OFFICE VISIT, 5/19/21 CHIROPRACTOR OFFICE VISIT, 5/20/21 PHYSICAL THERAPY OFFICE VISIT, 5/24/21 CHIROPACTOR OFFICE VISIT, 5/25/21 PHYSICAL THERAPY OFFICE VISIT, 5/26/21 CHIROPRACTOR OFFICE VISIT, 5/28/21 PHYSICAL THERAPY OFFICE VISIT, 5/31/21 CHIROPRACTOR OFICE VISIT, 6/1/21 PHYSICAL THERAPY OFFICE VISIT, 6/2/21 CHIROPRACTOR OFFICE VISIT, 6/3/21 PHYSICAL THERAPY OFFICE VISIT. OUTCOME: UNKNOWN SYMPTOMS: SHOULDER PAIN, BACK MUSCLE/BONE PAIN, CHEST MUSCLE/BONE PAIN, LIMITED MOBILITY. SYMPTOMS STARTED 4/1/21 AND HAVE PERSISTED THRU TODAY'S DATE.

Day 1: Within 1 hour of shot, feelings of delirium and low-grade fever (99 F), posterior neck pain and stiffness. 4 hours after shot, arm pain (significantly less than with first dose). Chills. Joint pain (fingers, knees, hips). Mild headache. After 8 hours, chills and fever subsided, but hot; sweaty. General fatigue. At 12 hours, worsening but intermittent finger, hand and knee tenderness. Clamminess, sweats, intolerance to both heat and cold. Eye sensitivity. Day 2: Severe body aches. Mild asthma exacerbation (effectively alleviated with albuterol sulfate inhalation). Severe fatigue. Description was, "like having just gotten out of a pool, but whole body instead of just swimsuit being wet." Light sensitivity/aversion with dull headache. Difficulty concentrating. Elbow joint paint. Fever. Day 3: Significantly reduced headache, fever and body "heaviness." Pain in legs and elbows improved or eliminated. Gastric and esophageal inflammation. Diarrhea; stomach bloating; nausea; gas; gastritis. Mild. Esophageal and splenic discomfort (upper-left quadrant tenderness). "Brain fog" persists. Better than previous day. Forgetfulness. Insomnia. Day 4: Significantly reduced symptoms. Pain virtually gone. Gastric symptoms persist, but reduced. Somnolence. Day 5 - 7: Complete improvement, however notable axial (underarm) lymph swelling and tenderness. Day 7 - 14: Resolution of all symptoms, mild lymph swelling persists. Day 17: Lymph swelling resolved.

4 days after the covid-19 vaccine 2nd dose, I have severe pain started in the left back neck. The pain started from the neck and goes up to back left head, head above the ear and left ear. Left part of neck becomes stiff. The head pain is burning. If someone touches the pain points in the head, I don't have a pressing pain but still have a burning pain. Initially though it was due to a sleeping position(pillow) change. But as day progressed, pain increased and saw left armpit swelled. Went to a walking clinic and Dr. said it is due to muscular pain and asked me to take over-the counter pain killer. I took the pain killer and pain reduced but when I stopped the medication, pain reappeared. I also found a pattern in the pain. Neck stiffness and pain starts at around 2:00 pm and it increases to 8/9 at around 3:00 to 3:30. The pain at peak is extreme pulsive burning pain and automatically reduces at around 4:30 pm to level 2/3. This happens every day. I always have pain of 2/3 during the throughout the day. Revisited the Same walk-in clinic and other Dr. said, It might be possibly linked to the Vaccine and they have few more similar cases reported. She prescribed me the Muscle relaxer and steroid and suggested me to contact my PCP for few blood work. I didn't take any of them before contacting my PCP. PCP ordered some blood work and CTScan. Suggested me to take muscle relaxer and not to take Steroid as It will reduce the vaccine effect. The Blood and CTScan report came normal. She also referred me to Neurologist. Neurologist also looked at report and said, everything looks normal. I took muscle relaxer. Neck stiffness and head pain is reduced but I still have pain. It repeats at the same time interval and in same manner

swelling on face around eye, shingles-like rash, Persistent, intense itch on other areas including genitals but no visible rash.

The lot number for the first dose of vaccine was taken on 04/06/2021is: EW0153, and the lot number for the second dose of vaccine that was taken on 04/25/2021 is: EW0162. He started swelling really bad, and the mortician said all of his organs were very swollen. He was in terrible mental condition, he couldn't think. He had so much swelling that his feet were blue. He was so swollen in his brain he couldn't make basic cognitive decisions. His chest was so swollen his chest was up to almost double his normal size. He was under severe mental strain to the point that it took him 14 hours to make a 10 hour drive. He was dealing with maratil strain and shot himself on 05/20/2021.

Swollen lymph nodes under armpit of injection; dull headache; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old male patient received the second dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA Vaccine; Lot number: ek873c), via an unspecified route of administration in the left arm on 30Mar2021 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma and high cholesterol. The patient did not have any allergies to medications, food, or other products. The patient did not receive any medications within two weeks of vaccination. The patient previously received first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA Vaccine; Lot number: ENGZ06), via an unspecified route of administration in the left arm on 09Mar2021 at 10:00 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID-19 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 31Mar2021 at 15:00, +30hrs after second shot, the patient experienced swollen lymph nodes under armpit of injection site and dull headache. The patient did not receive any treatment for the reported events. The adverse 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 swollen lymph nodes under armpit of injection site and dull headache was not recovered at the time of this report. No follow-up attempts are needed. No further information is expected.

1st Dose: Headaches, swollen lymph nodes 2nd Dose: Fatigue, body aches. Chest pains bad enough I went to the ER, 2 days later I went back to the ER because I my eye swelled shut, and my neck swelled up, and I had severe pain when I tried to swallow.

Felt a strange sensation in left neck, faceand sinus; Tonsils are sore; feel a strange sensation in my left neck, face and sinus.; This is a spontaneous report from a contactable consumer, the patient. A 39-years-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the arm right on 02Apr2021 at 12:45 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to nuts of all kinds and swimming fish (not shellfish) allergy. Patient received other medications in two weeks which included paracetamol (TYLENOL), guaifenesin (MUCINEX), ibuprofen (ADVIL), paracetamol; acetylsalicylic acid; caffeine (EXCEDERINE) all from an unknown date for an unspecified indication. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 02Apr2021 at 13:30, the patient experienced a strange sensation in his left neck, face and sinus. It was subtle. More alarming was that his tonsils were soar. And this had gotten progressively worse as the day had gone on. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Clinical outcome of neck strange feeling, lymph node pain, feeling strange was not recovered at the time of reporting. No follow-up attempts are needed. No further information is expected.

7 DAYS POST-ADMINISTRATION, HALF OF PT'S FACE WAS SWOLLEN WITH NO SENSATION. EXPERIENCED SUDDEN SHARP HEADACHES, CHEST PAIN

This is a spontaneous report from a contactable healthcare professional, the patient. A 39-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735) via an unspecified route of administration in the left arm on 30Mar2021 at 10:15 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was not allergic to medications, food or other products. The patient previously took the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration in the left arm on 09Mar2021 at 10:15 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 25Mar2021, the patient underwent a Nasal Swab test (colour anterior nares PCR Test) and the result was found to be Negative. On 01Apr2021 at 18:30, the patient experienced Axillary adenopathy - swollen lymph tissue across left underarm. The patient did not receive any treatment for the reported event. The event did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. The clinical outcome for the event axillary adenopathy was recovering at the time of the report. No follow-up attempts are needed. No further information is expected.

Pt reported delayed onset of adverse reaction: 39 y/o hispanic male pt with NKA to food and drugs received first dose of Pfizer EW0377 on 06/17/21 reported difficulty breathing and ?I felt like my face was swollen.? Symptoms started 24hr post vaccination and lasts x2 days. Second dose was held upon visit on 07/15/21. Pt denies neck swelling, pt did not go to the hospital and ?I just got better after 2 days.

Swollen lymph nodes (very painful); Red, swollen, raised rash at injection site; Red, swollen, raised rash at injection site; Red, swollen, raised rash at injection site; Fatigue; Deep sweat; elevated heart rate; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0171) via an unspecified route of administration in the arm left on 30Apr2021 at 08:00 (at the age of 39-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included sambucus nigra (ELDERBERRY), allium sativum, ganoderma lucidum, lentinus edodes, hericium erinaceus, inonotus obliquus (MUSHROOM IMMUNE SUPPORT), benzalkonium chloride, sodium chloride (ALIVE) and multiv; all from unknown date for unspecified indication. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via an unspecified route of administration in the arm left on 10Apr2021 at 08:00 (at the age of 39-year-old) as a single dose for COVID-19 immunisation and Penicillin on unknown date for unknown indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01May2021 at 01:30, the patient experienced swollen lymph nodes (very painful), red, swollen, raised rash at injection site, fatigue, deep sweat and elevated heart rate. The clinical outcome of the events swollen lymph nodes (very painful), red, swollen, raised rash at injection site, fatigue, deep sweat and elevated heart rate was not resolved. No follow-up attempts are needed. No further information is expected.

Retaining water; Legs are swollen, feel heavy, ache.; Legs are swollen, feel heavy, ache.; Legs are swollen, feel heavy, ache.; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration in the arm left on 26Apr2021 at 12:15 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. The patient's medical history was reported as none. It was unknown whether the patient had any known allergies. Concomitant medications included multivitamin (MANUFACTURER UNKNOWN), glucosamine (MANUFACTURER UNKNOWN) and testosterone supplement (MANUFACTURER UNKNOWN), all were taken for unknown indication on an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 27Apr2021 at 00:00, the patient experienced retaining water, legs swollen, feel heavy and ache. It was unknown whether the adverse event resulted in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. It was unknown whether the patient had received any treatment for the reported events. The clinical outcome of the events retaining water, legs swollen, feel heavy and ache was not resolved at the time of this report. No follow-up attempts are needed. No further information is expected.