Pfizer

Pleasant 40-year-old male comes in the emergency room with concern related to allergic reaction. Patient had received his COVID-19 vaccination approximate 60 minutes ago, at approximate 45 minutes after vaccination he developed flank pain left greater than right rated a 3 out of 10 extending down to his thighs he also noted a scratchy type sensation in the back of his throat feeling as if he needed to frequently clear his throat. The symptoms have been ongoing now for the past 15 to 30 minutes with no increasing or change in symptoms. Has never had allergic reaction in the past, unsure of previous Covid 19 infection though he describes in February of last year having upper respiratory illness which time he lost his sense of taste and smell. Currently denies any fevers, chills, nausea or vomiting. Denies any diarrhea. Denies cough or shortness of breath. Denies any swelling of the lips, face, eyes or nose. Denies any rash. Upon presentation emergency room patient was seen, evaluated, treated following standards of care given. Given patient's presenting symptoms and the recent COVID-19 vaccination will treat patient as adverse allergic reaction. Patient was given 50 mg of Benadryl IV, 20 mg of Pepcid IV, 10 mg of Zyrtec p.o. and 125 Solu-Medrol IV. Patient was observed in the emergency room for minimum of 2 hours, with complete resolution of symptoms. Patient was discharged home on Zyrtec to take 10 mg by mouth daily as well as Pepcid 20 mg by mouth twice daily for minimum of next 14 days, prednisone 20 mg 1 by mouth daily x5 days. Patient was given a prescription for EpiPen should his symptoms return or progress, recommend he call 911 and return immediately. Risks and warnings were discussed in detail, all questions were answered, patient verbalized understanding agreement plan of care.

Lymphadenopathy/Enlarged Lymph node; This is a spontaneous report from a contactable physician. A 40-year-old male patient received bnt162b2 (BNT162B2 reported as Pfizer-Biontech Covid-19 Vaccine and also reported as Covid Vaccine; unknown lot number and expiration date), via an unspecified route of administration left deltoid (reported as once by injection on the left deltoid) on 18Dec2020 at a single dose for covid-19 vaccination. The patient has no medical history and concomitant medications. The physician reported that he got the COVID Vaccine on 18Dec2020 and he got Lymphadenopathy as a possible side effect of the vaccine. It was recently (03Jan2021), he noticed an enlarged lymph node (Lymph node is on left supraclavicular, so above the clavicle on the left side). It could be unrelated, but he was told to call and report it. He would like to know were there patients in the clinical trial who got lymphadenopathy (which part of the body). He did not received treatment. He knows that lymphadenopathy was reported in the study. The reported considered the event as non-serious. The outcome of the event was not recovered. Information on the lot/batch number has been requested.

Per reporter: "I received the COVID vaccine on 12/29/2020 (first dose). The first couple days I had a really sore left arm, but didn?t feel any ?side effects? until about Wednesday, 1/6 (about a week later). I remember waking up to a sore left side of my upper body. The left side of my neck, chest, arm, and lymph node (under my left arm) felt weird. It was until about Saturday night, 1/9, that I felt my left under arm lymph node noticeably swollen. I had a bad headache and loss of energy, and overall feeling unwell. No fever or night sweats to report. I was absent from work on 1/11 and 1/12, as a result. 1/13 was my first day back and feel better. The swollen left lymph node is no longer present, but still slightly tired. I did not seek Medical Care for my symptoms.

Swollen Lymph Nords; This is a spontaneous report from a contactable consumer (patient). A 40-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EL3246, via an unspecified route of administration at left arm on 08Jan2021 12:00 at single dose for COVID-19 immunization. Facility type vaccine was at military base. The patient medical history was not reported. Concomitant drugs was none. No other vaccine in four weeks or other medications in two weeks. The patient experienced swollen lymph nodes on 09Jan2021 15:00. No treatment received, no COVID prior vaccination and COVID was not tested post vaccination. The outcome of the event was unknown.

Left axillary lymph node keeps swelling several days after the vaccination. And connected lymphatic vessels are also swelling. I was wondering if I would avoid the second shot when the lymph node still swells.

general ache/pains, headache woke me up ~3:30am. movement hurt, pain progressed, headaches got worse, never went away. nausea, fever throughout the day, general tiredness and increased join point all day. swollen glands in arm pits. headache pain completely impaired daily activity. Tylenol in the afternoon for fever, dramamine for nausea Effects lasted 24 hours... headaches persisted 5+days

Reports he has been diagnosed with Guillain Barre syndrome. Symptoms started with 2 fingers tingling 1/11/21. Progressively increasing in severity. Now has numb fingers and toes. Initiating IV therapy 1/22/21.

Progressive Burning of fingers and toes followed by worsening tingling and hyperasthesia . Notable Symptoms started 48 hrs post second dose of covid 19 vaccination , worsened over the next 7-10 days. Basic metabolic lab work done. Seen by neurology on 1/21/2021. Started on IV therapy on 1/22/2021. Ongoing transfusion treatment in an outpatient setting

Guillain Barre syndrome/Symptoms started with 2 fingers tingling; This is a spontaneous report from a contactable nurse reporting for a patient. A 40-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK4176), via intramuscular on 09Jan2021 at single dose in left arm for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EJ1685), via intramuscular on 22Dec2020 at single dose in left arm at the age of 39-year-old for COVID-19 immunization. Reported he was diagnosed with Guillain Barre syndrome. Symptoms started with 2 fingers tingling on 11Jan2021. Progressively increasing in severity. Now had numb fingers and toes. Initiating IV therapy on 22Jan2021. The adverse event result in Doctor or other healthcare professional office/clinic visit. The outcome of the event was unknown.; Sender's Comments: As an individual case report there is not enough evidence to establish a causal relationship with the suspect vaccine. Currently there is no clear biological plausibility between the vaccine use and the even onset. More information such as complete medical history and concomitant medications are needed for fully medical assessment. 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.

Mild headache; injection site swollen and sore. Swollen lymph node on left side of neck with mild tenderness.

tiredness; headache; muscle pain; chills; injection site swelling; feeling unwell; swollen lymph nodes - Moderate-severe (Left axillary lymphadenopathy); injection site pain; This is a spontaneous report from a contactable physician (patient). A 40-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection. lot number: EL3249), via an unspecified route of administration on 21Jan2021 at a single dose on left arm for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior to vaccination. No vaccines received 4 weeks prior to vaccination. The patient experienced injection site pain on 21Jan2021. On 22Jan2021 (24 hours after vaccination), patient experienced tiredness, headache, muscle pain, chills, injection site swelling, feeling unwell and swollen lymph nodes - moderate-severe (left axillary lymphadenopathy). All occurred for a duration of 24 hours, except for event swollen lymph nodes - Moderate-severe (Left axillary lymphadenopathy) in which reported duration was 48 + hours. The patient was treated with ibuprofen for the events. The patient was not tested for COVID-19 post vaccination. The patient has not recovered from the events.

Within 5 minutes of getting the shot on 2/6 I felt pain in the upper arm that moved down to forearm into left pinky. At approximately 3 pm arm started to hurt at the injection site. Iced for the next 36 hours until the swelling went down. On 2/7/21 at 10 pm started feeling like sickness was starting. On 2/8/21 was lethargic with body aches, headache, dry cough, and temperature up to 101.5 degrees F. Took 325 mg of Tylenol every 6 hrs. 2/9/21 up dose of Tylenol to 500 mg every 6 hrs as fever increased. Experienced night sweating and severe joint pain in hips, lower back, and along the upper spine. Fever broke at approximately 7 pm 2/9/21. Joint pain continues through 2/10/21

I had practically no side effects from shot #1....shot #2 was different. Starting about 6-8hrs after injection I started to feel lethargic. By 10hrs, I started with varying chills/sweats that lasted all night, injection site soreness, and soreness in left breast area. The next day I was extremely exhausted and had trouble staying awake. Muscle aches in both shoulders and neck. Also had varying fever from 100 up to 104.1 throughout the day. At 36hrs after injection. I took 2 Advil to help with the muscle aches...nothing taken to this point. 48hrs After injection some energy returned, but still lethargic throughout the day, and occasion fever between 100-101. During shower, I noticed swelling under my left armpit, not present on the right side. At 60hrs after injection, fever gone, energy returned...lingering soreness of left shoulder and breast area and swelling under left armpit remains. At no point did I have any breathing or lung issues...but otherwise it felt like I had a bad flu (minus the coughing/wheezing) for 2 days.

under my lymph nodes are very painful; right arm was sore for first 2 days/under my right arm are very painful; This is a spontaneous report from a contactable consumer (patient himself). A 40-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EN5318), via an unspecified route of administration in right arm on 12Feb2021 13:45 at single dose for COVID-19 immunisation. The patient's medical history included COVID-19 from an unspecified date in Nov2020 (diagnosed with COVID 19 at the end of November 2020 but tested negative since from Dec onwards 2020). Concomitant medication included finasteride at 1 mg (within 2 weeks of vaccination). 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. The patient has not been tested for COVID-19 since the vaccination. It was reported that, my right arm was sore for first 2 days on an unspecified date in Feb2021, however since Monday (15Feb2021 06:00 AM) under my lymph nodes, under my right arm are very painful. The events were considered as non-serious by the consumer. The patient did not receive treatment for the adverse events. The outcome of the events was not recovered.

Severe fever blister outbreak consisting of 5 sores developing simultaneously. Very atypical for me. Not sure of anything else that it could be connected to.

Within a day and a half swelling of the face, especially around eyes. Rashes on face at brow and cheeks with flaking skin, in addition to hive on forearms. The following morning, today, it has become much more severe.

Starting at 8pm on vaccination day I got loopy and disoriented, and had a hard time speaking intelligibly. I also had trouble with balance and fine motor skills. Had some personality changes too: became very moody with erratic mood swings. The next day I slept all day because of exhaustion and aches. When I woke up on Wednesday (36hrs later) I was literally screaming in pain because of how bad my arm and shoulder hurt. It hurt to move it, and hurt not to move it. It was excruciating and ibuprofen didn't seem to help at all. Throughout Wednesday I could hardly move my left arm. Getting dressed or washing my hair was very difficult and very painful. I was also still very uncoordinated. My left armpits lymph nodes were so swollen that (1) it filled in my entire armpit so there was no more pit, just a very soft bulge, and (2) the fluid extended all the way to my chest and it looked like I had one breast and one pec.

Started having swelling to left axillary lymph nodes and pain to left collar bone and left axillary area (pain and lymph nodes are still swollen) Fever, chills, body aches, fatigue, headache x 4 days

2 days post vaccine small hard lump under chin developed. 4 days post vaccine lump / lymph nodes severely enlarged the size of a racquetball and area around chin and neck severely swollen. Developed chills, fever, fatigue, body aches, shortness of breath, vomiting, painful to swallow. Due to pain from swelling was administered Percocet, Fentanyl, Ketorolac, and Morphine, 2 COVID test were negative. Due to difficulty breathing issues admitted through ER to hospital critical care unit 9 days post vaccine. Hospital stay 4 days 3/27/21 thru 3/30/21. On 4/7/2021 still have hard swelling in neck and under chin area

shortness of breath; 2 days post vaccine small hard lump under chin developed.; 4 days post vaccine lump / lymph nodes severely enlarged the size of a racquet ball and area around chin and neck severely swollen; chills; fever; fatigue; body aches; vomiting; painful to swallow; This is a spontaneous report from a contactable Other-HCP (patient). A 40-year-old male patient received second dose of BNT162B2 (BNT162B2, Solution for injection, Lot number: EN6206, Expiration date was not provided) via unspecified route of administration at left arm on 18Mar2021 09:30 at single dose for COVID-19 immunisation. The patient medical history included type 1 diabetes and Sulfa drugs. Concomitant medications included insulin human (HUMULIN R), insulin human injection, isophane (HUMULIN N) and sildenafil. Historical vaccine included first dose of BNT162B2 (lot number: EN6202) via unspecified route of administration on right arm on 25Feb2021 12:30 PM for COVID-19 immunisation. If other vaccine in four weeks and Covid prior vaccination reported as no. Patient tested Covid post vaccination. On 20Mar2021 09:00, 2 days post vaccine small hard lump under chin developed. 4 days post vaccine lump/lymph nodes severely enlarged the size of a racquet ball and area around chin and neck severely swollen. The subject developed chills, fever, fatigue, body aches, shortness of breath, vomiting, painful to swallow. Due to pain from swelling Percocet , Fentanyl, Ketorolac, and Morphine were administered. It is also reported that the subject received antibiotics for the adverse events. 2 COVID test were negative. Due to difficulty breathing issues the subject was admitted through ER to hospital critical care unit for 9 days post vaccine. The subject was still in hospital 11 days post vaccine. The patient underwent lab test procedure included Nasal Swab (SARS-CoV-2 test): Negative on 26Mar2021 and Negative on 27Mar2021. The outcome of the events was not recovered.; Sender's Comments: Assuming a plausible drug-events temporal association, the company cannot completely exclude a causal association between the reported, serious dyspnea and BNT162B2 administration. The impacts 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.

4/10/21, Swollen/ sore lymph nodes left arm pit. 4/12/21, Trouble swallowing food. Flare up of EoE 4/13/21, Dizziness, low grade headache, tingling of skin on face and hands. Elevated response to seasonal and food allergies . Ongoing 4/15/21, Swollen/ sore lymph nodes right arm pit.

My lips became extremely red and swollen a couple of hours after the shot. I think there was some other minor face swelling around the nose, but the lips were the main issue. I took Benadryl for a few days and the lips were back to normal in about a week.

My leg was numb; Felt swollen from my right leg.; This is a spontaneous report from a contactable consumer. A 40-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Er8727), via an unspecified route of administration in Left Arm on 26Mar2021 04:30 PM as single dose for covid-19 immunization. Medical history included allergy to fish. The patient's concomitant medications were not reported. On 26Mar2021, 04:45 pm the patient reported his leg was numb and felt swollen from my right leg. Until he took a Benadryl, the feeling in leg came back after hour. The outcome of event was recovered on an unknown date in 2021. Information on the lot/batch number has been requested.

Received shot in right arm on Saturday . On Sunday night I noticed a baseball sized lump under right arm below arm pit. Feels tender to touch but not excrutiating pain

Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Systemic: Shakiness-Mild

Swollen lymph nodes under injection arm, injection site swelling and redness, fatigue, dizziness, lightheadedness, nausea, joint pains

Developed severe abdominal cramps on my left side around 7 p.m. on Wednesday, April 28. Cramps were intermittent and in varying degrees of intensity. Cramps continued through Friday, April 30 with varying intensity. Attempted to treat with Tylenol and GasX. Starting around 10:30 a.m. on Saturday May, 1, the pain in my left side increased in intensity and was not waning. After consulting with a telehealth practitioner, I went to the emergency room and was quickly admitted. My blood and urine were tested, along with CT scans of my body. The CT scan revealed that blood was no longer reaching two parts of my left kidney and I was diagnosed with a arterial thrombosis. I was fully admitted to the hospital and a heparin drip was immediately started.

Had seizures and ended up in emergency room; Had seizures and ended up in emergency room; scar in left arm/scar in his left arm before he had a seizure; 'he could feel a bump, it was like a bump in there. So, it was between his armpit his heart where he felt the bubble; This is a spontaneous report from a contactable consumer (parent). A 40-year-old male patient received the second dose of BNT162B2 (lot number and expiry date were not reported), via an unspecified route of administration, administered in left arm on 14Apr2021 (at the age of 40-year-old) as single dose indicated to prevent from Corona virus (Covid-19 Immunization). Medical history included seizures and gout. The patient's concomitant medications included unspecified medication for seizures. The patient previously received the first dose of BNT162B2 (lot number: ER8730) on 24Mar2021 for Covid-19 Immunization. The patient got the second Pfizer shot later this month, left the office, 45 minutes later (on 14Apr2021) he had seizures and ended up in emergency room. He has had small seizures but they are not back to back, of and on throughout the years and now we are saying that maybe COVID Vaccine shot is what provoked him to, what made him had seizures. Reporter stated, even though he has had seizures in the past like it could be 2, 3 years apart for one. But the shot it caused him to have another seizure, but he is not going to continue to have seizures, as he is on medication (unspecified medication) right now. But the medication is on, if they take him off it, he could have multiple seizures constantly (name of medication not clarified further). Also on 14Apr2021, the patient also had a scar in left arm, it is another symptom he had. He had the scar in his left arm before he had a seizure, he said over here between his heart and his arm felt like a (incomplete sentence), now they don't know if he had a one scar or what it says but he says that 'he could feel a bump, it was like a bump in there. So, it was between his armpit his heart where he felt the bubble' (not clarified further). The patient underwent laboratory test which included: blood work, a urine sample and they did a CAT scan to see knowing the problem in his brain, all on 14Apr2021 with unknown result. The day of the test was on the 14th, it would have been on a Wednesday. It was the same day that he got the second shot. So, he had these test done on 14Apr (14Apr2021). Reporter confirmed of getting the test results on Thursday, so did not have the details. Therapeutic measures were taken as a result of seizures which included Levetiracetam 500 mg tablet, he takes one tablet twice a day, so he takes two tablets a day. This was ordered by his doctor in emergency room. The outcome of the events was unknown. Information on the lot/batch number has been requested.

Site: Pain at Injection Site-Severe, Systemic: Body Aches Generalized-Severe, Systemic: Confusion-Severe, Systemic: Diarrhea-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: vivid dreams-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Joint Pain-Severe, Systemic: Lymph Node Swelling-Medium, Systemic: Nausea-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Systemic: Weakness-Mild, Additional Details: general feeling of increased inflammation of joint pain

I was vaccinated on Friday 5/7/2021. I got a low fever on the same night and the day after. On Sunday morning 5/9/2021, I feel my inner lap parts are itchy. During the day, I found some rashes here and there over my body. Some rashes are swelling bumps. They are itches. I found my head skin under my hairs are itchy too. It was getting worse throughout the whole day.

HCP indicated tracheitis; Less of a passageway; Fair amount of coughing/Dry cough; Swelling in the neck area; Fatigue; Is there any correlation between the delated anaphylaxis and ingredient?; Throat tightening with difficulty breathing; Throat tightening with difficulty breathing; This is a spontaneous report received from a contactable consumer (reported for himself). A 40-years-old male patient received first dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot Number: EW0164) administered in left deltoid via an unknown route of administration on 16Apr2021 at 12:50 pm as 1st dose single for COVID-19 immunization. It was reported that that he received the vaccine in his left arm, the bicep muscle, or above the bicep. He states the muscle on the shoulder area. Patient states that asthma was in the lungs and chest. He has had mild intermittent asthma and gets it 4 times a year. There was no prior Vaccinations, no adverse events within 4 weeks. Medical history included asthma (patient was diagnosed 30 years ago), allergic to shellfish. The patient's concomitant medications were not reported. On 16Apr2021 patient experienced is there any correlation between the delated anaphylaxis and ingredient, throat tightening with difficulty breathing (Throat tightness and dyspnea), less of a passageway, fair amount of coughing/dry cough swelling in the neck area and fatigue. On 19Apr2021 at 10:15 HCP indicated tracheitis. The patient states that he got the vaccine on 16Apr2021 at 12:50 pm and isn't sure exactly when the swelling started because he got a little fatigued. Patient states that it was about 3-5 hours after and at a certain point he noticed it. It was reported that a half an hour to an hour later patient throat started to tighten, it gets triggered by certain stimuli, steam and vocalization, and rubbing the area. patient states that he could reproduce the issue if he rubs the area, the frequency has decreased, and in that case, it has improved. It was reported that patient was diagnosed with tracheitis on 19Apr2021 at 10:15 and it was still ongoing, or the effects of it are. Patient states that what he feels in the front of his throat near the trachea and up a little further was inflammation. Patient gets the symptoms of the tightening of the throat, and it is inflamed there is less area to breath. Patient states that his understanding of the tightening of the throat and dry cough are all symptoms of the tracheitis. It was reported that the first symptom experienced after the injection (at least 2-3 -4 hours), patient had fatigue first then probably a half an hour to an hour later the swelling started. patient believes the fatigue has gone away, but not 100 percent sure. patient states that there are times he has felt fatigue and is not 100 percent of the cause. patient states that if he does feel fatigue, he assumes it because of the tracheitis. patient states that these events happen when he needs to get area in his throat, and it might cause the fatigue. patient states that the coughing is parallel with the throat tightening, when he wants to open his airway or pass way the coughing seems to occur. Patient states he gets relief or a more open passageway and the coughing reflex or coughing bouts are less, when he gets the tightness of the throat or the inflammation he sort of goes into coughing. The outcome of the event for hcp indicated tracheitis was not recovered and unknown for the other events, whereas the outcome of the event fatigue was recovered. Follow up were needed, further information has been requested. 07May2021: Follow-up spontaneous report received from a contactable consumer. No new information was reported.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021524696 Pfizer

40 y/o M with no PMHx, non smoker, takes Finasteride 1 mg for hair growth, nonsmoker, received first Pfizer COVID-19 vaccine on 4/12/21 to left deltoid (had mild soreness x 2 days, without other sx) presented to ED 4/15/21. Presented to ED 4/20/21 with L calf pain x 4 days starting around the evening of 4/15 and into 4/16. Initially attributed symptoms to a muscle strain given pt bikes 25 miles a day and lifts/frequent exercise- was able to exercise on 4/16 but stopped after that to try to rest the leg. Has been applying ice and taking Aleve with no relief. Shortly after, noticed new swelling in the calf and this morning noted that swelling had also spread to the front of his shin. Denied numbness, tingling, weakness in the leg. Was advised by a family member who is radiologist to present to ED for further evaluation. Found on exam to have left calf swelling, Ultrasound Doppler with extensive deep venous thrombosis of the left lower extremity from the level of the posterior tibial extending proximally to the common femoral vein with areas of both occlusive and nonocclusive thrombus. Evaluated by interventional radiology, deemed no need for intervention. Initially treated with lovenox and then discharged from the ED on apixaban 5mg daily. Symptoms resolved in days after and as of 5/18 remains on apixaban symptom-free.

Pfizer-BioNTech COVID-19 Vaccine EUA: patient presented to urgent care reporting shortness of breath, cough, and chest pain. Transferred to emergency department then admitted to current facility for a management of new onset heart failure with possible etiologies of myocarditis or sarcoid. Also found to have LV thrombus, anemia, and lymphadenopathy. Patient initiated on medications to manage heart failure and anemia and anticoagulated. Patient improved and discharged to home medically stable.

LYMPH NODE ON LEFT SIDE OF NECK SWOLLEN, TENDER TO TOUCH. HAS BEEN 19 DAYS, PT WONDERING WHEN IT WILL SUBSIDE AND IF HE SHOULD GET THE SECOND VACCINE OF THE SERIES OF 2.

Immediate nausea, hot flash and heart palpitations at time of injection, soreness for 3 days, and on the 4th day I had a general feeling of malaise, which worsened until I developed a fever. Severe fatigue and constant fever as high as 105 for three days, and finally went to the ER. Immediately treated for sepsis. Full blood panel, blood cultures, x-ray and CT scan. Also ran some additional cultures for respiratory pathogens. The Dr?s had a tough time determining what it was. They saw a very small area which they called pneumonia, however, I?ve had pneumonia and this was not what it was. Final discharge paperwork stated Systemic Inflammatory Response Syndrome.

Patient has a normal resting heart rate of approximately 60-65 bpm. The day after receiving the Pfizer covid vaccine, heart rate dropped to 25 bpm, and patient passed out. Heart rate remained between 30-40 bpm for approximately 1 1/2 hours. Patient continued to experience a low heart rate of approximately 45-50 bpm for a week, as well as swollen lymph nodes and mild chest pain. As the swollen lymph nodes resolved over the week, patient's resting heart rate started to get back to the normal 60-65 bpm. Patient reported to internal medicine clinic on May 7, 2021. Blood test performed on May 8, 2021 - results normal. Echocardiogram and halter monitor performed on May 24, 2021 - results normal. Cardiology visit on June 2, 2021. Cardiology suspected possible myocarditis, vagus nerve stimulation, and/or allergic reaction as result of first dose of vaccine.

Painful lymphnode in left armpit; This is a spontaneous report from a contactable other hcp. A 40-years-old male patient received BNT162B2, (COMIRNATY, solution for injection; Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 04Mar2021 10:00 AM as 2nd dose, single for covid-19 immunisation. The patient medical history was not reported. No other vaccine in four weeks. Patient has COVID prior vaccination. Patient has not COVID tested post vaccination. No Known allergies. Concomitant medication included omeprazole (OMEPRAZOLE) taken for an unspecified indication, start and stop date were not reported. The patient experienced painful lymphnode in left armpit on 05Mar2021. Outcome of the event was recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained .

Noticeable but relatively minor pain and swelling in armpit of same arm vaccine received; minor pain in shoulder and pectoral muscle same side. Armpit pain 3/10, other pain 1/10

the right arm pit is more swollen than the left arm pit. He says there are no bumps in the arm pit, just swelling./swollen and there is little bumps present.; Concerned about the inflammation; That evening he had pain in his arms; and body aches which today have resolved; This is a spontaneous report from a contactable consumer (patient) reported for himself for the 1st Dose administered. A 40-years-old male patient received bnt162b2 (BNT162B2, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in Arm Right on 13Jun2021 as 1ST DOSE, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced the right arm pit is more swollen than the left arm pit and said there are no bumps in the arm pit, just swelling. swollen and there is little bumps present. (swelling on 15Jun2021 with outcome of not recovered , that evening he had pain in his arms on 13Jun2021 with outcome of recovered , and body aches which today have resolved on 13Jun2021 with outcome of recovered , concerned about the inflammation on 15Jun2021 with outcome of not recovered.

At 6:00, hives appeared on my body, left covid arm broke out first in hives. Left hand became very swollen, and got worse through the night. The next day hand was still swollen.

I got the vaccine shot on a Thursday, and woke up the next Friday morning feeling strong tingles on my face, weird sensations, & some swelling of lymph nodes had started. i thought i might be having a minor reaction, or it felt like i might. Saturday morning i woke up w' some bumps & inflammation w' a painful red sore on my nose bridge next to my right eye. i almost went to urgent care Saturday night but talked myself out of it, then Sunday woke up & had more inflammation & swelling, tenderness, & pain & discomfort. i went to my doctor on Monday as it felt intolerable & was getting worse, i told him about getting the vaccine, reporting it felt like my immune system was confused or something, he said there were some vaccine reactions, that it was possible for it to affect people differently, that it was rare, that he didn't know, but he said it looked like shingles was attacking me & referred me to the Eye Institute to see Dr, who tested me even as my eye was swelling shut. There was a danger it could get in the eye. Prescribed Acyclovir antiviral. My condition kept worsening but i kept taking the antivirals & eventually responded well to them. It hurt everywhere, & the pain was indescribable, at almost every level. It was excruciating. i was fighting off the attack by the 3rd week & could open my eye, but was still in a lot of pain, had to rest almost all the time, could barely eat & speak for weeks, or go outside in the sun for more than a couple minutes, because of the brightness etc. & was overall incapacitated for about 5 weeks. It was completely disabling. The doctors were very impressed w' how intense the condition was, & showed me to all the students at the Eye Institute. They were pleased w' how well i have been healing up. My immune system feels strong too. It was just brutal but i am recovering now, thankfully. i still feel prolonged effects though, w' even some pain at times during the day, or if i am active then i feel like i have to rest. i am just really thankful it doesn't hurt like that now. There is probably gonna be some permanent scarring because of the damage to my face from the nervous system inflammation, as my face is heavily scarred now because of the attack, i could maybeget plastic surgery for the scarring on the right side of my face.

Under arm pain; Noticeable swelling under armpit when palpated; received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6206) via unspecified route of administration in left arm on 05Mar2021 at 18:00 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. The patient medical history was 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 did not receive any other vaccines within 4 weeks prior vaccination. The patient received other medications (unspecified) within two weeks of the vaccination. On 09Mar2021 at 08:30, the patient experienced under arm pain that occurred few days after the vaccination, went away and came back, for total of almost two weeks now. The patient noticed swelling under armpit when palpated. The events not resulted 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 events. The clinical outcome of the events under arm pain and swelling under armpit when palpated was not recovered. No follow-up attempts are needed. No further information is expected.

Client received 2nd COVID vaccine on 05/10/2021 at 3pm, 3 days later adverse reaction began of swollen lymph nodes. Two weeks later the swelling went away. The injection site took a month to heal from having swelling. At this time client report he is having weird reactions to bug bites that is causing him to take up to one week to heal from the bites. Client lymph nodes have again began to swell under both armpits, they feel tender to touch. Client has not seen a medical provider for adverse reaction.

Following my second Pfizer dose on on 4/2/21 I began having a strong burning pain in my right forearm and wrist area. I perceived this initially to be carpal tunnel and it started on 4/5/21. I self treated with ibuprofen for a few days with no improvement, then saw my PCP on 4/9. My PCP thought this to be tenosynivitis, and prescribed Methylprednislone. The steroid treatment helped for the first few days but then the pain quickly spread to my right leg in the thigh area. Same type of pain, burning and intense. I was able to walk, but with a slight limp. I saw my PCP again on 4/15 to discuss the new symptoms. He began researching possible conditions and also ordered some blood tests for common auto-immune diseases (Uric Acid, C-Reactive Protein, CMP, ANA). Everything returned normal except for C-Reactive (value- 50+). To be sure it wasn?t a case of septic arthritis, I was placed on an antibiotic on 4/17 (Keflex) for 7 days. The Keflex did not help and actually gave me a slight fever (100.1) and I missed work on 4/19,20,21. I started to improve on 4/16 but the symptoms were still present. As a followup, my PCP ordered a more comprehensive blood panel to be reviewed at my next appointment on 4/30. The following blood tests were ordered: TSH 3rd Gen Blood, CBC, CMP (BAMP, TP ALB TBIL,ALK, AST, ALT), and LIPID Panel. On PCP appointment on 4/30, my symptoms continued to present in legs and right arm. All values from blood tests were normal. He ordered a lower back xray, which was scheduled for 5/11. At this point, my PCP referred me to a rheumetologist as he had exhausted his options. Unfortunately, the earliest rheumatology available was 5/18. On 5/18 appointment with rheumatology resulted in more tests: Parvovirus B19, Rheumatoid Factor, Serum Protein Electrophoresis, Urine PRotein/Creatinine Ratio, Immunoglobulin Assay-Blood, Immunofixation Procedure Blood, ASO- Blood, CPK Blood, Cyclic Citrullinated Peptide Antb, Hep B Surface AG, Hep C AB- Blood, Microalbumin urine random. All tests read as negative or normal except ASO. Rheumetologist referred me to Infectious Disease for further testing on 5/26, which resulted in the following blood tests: Ehrlichia Chaffeensis AB IGG, DNASE B Antibody, HLA Typing A B C Single - Blood, Legionnella -Blood, Prostate Specific Antigen, Unrinanalysis with Microscopic, Chlamydia and GC RNA AMP, Upper respiratory throat culture. He also ordered an ECG, a chest XRAY (PA and Lateral), CT scan of the pelvis. On 6/4 at a followup appointment, he ordered Crypto AG and C-Reactive Protein. At this point, CRP value was 180.74. I worked my last day of work on 5/14 as the pain became too intense to manage. As the week progressed, I slowly lost my ability to walk and care for myself. I could walk only 10-15 feet at a time, and doing so would cause a severe flare-up of pain in my legs. I was mostly bedridden for 2 weeks starting on 5/20 and was only getting up very minimally. I needed a wheelchair for transport to my appointments on 5/25, 5/26, 6/2, 6/3. By 6/4, I was barely able to walk to that appointment, but the office is very small so I was able to make a short distance. My rheumetologist, having reviewed all my normal test results ordered an EMG on my legs and right arm and also an MRI on my lumbar and cervical. EMG conducted on 6/24 and revealed some nerve damage and signs of neuropathy in my legs; and also carpal tunnel in the right wrist. MRI Lumbar (6/25) revealed some common lower back issues, but nothing affecting the nerves that may be the cause of my symptoms. MRI Cervical (7/12) completed but yet to be analyzed. As of today, July 12, I?m feeling much improved over how I felt in early June. I can walk a short distance of ? mile without needing a break. I have lost muscle tone and need to work on getting my strength back. My right arm has minimal pain but will flareup with heavy computer usage. However, for the past 2 weeks, my left arm (which has been symptom free since April) now has a similar burning pain that starts at the funnybone of the elbow and runs up to my wrist. The pain comes and goes but is sometimes very intense and can be debilitating. It is hard for me to open some doors with this hand or even hold a heavy cup of water. As a previously healthy person, and having done exhaustive testing, myself and my PCP believe I had a rare and negative reaction to the vaccine.

Have songs playing in my head; Unwanted thoughts; Sleeplessness; Swollen glands; This is a spontaneous report from a contactable consumer, the patient. A 40-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 31Mar2021 at 22:30 (at the age of 40-year-old ) as a single dose for COVID-19 immunisation. Medical history included epilepsy. Concomitant medication included lamotrigine (LAMICTAL) taken from an unknown date for an unknown indication. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via an unspecified route of administration on 10Mar2021 at 23:45 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 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. On 01Apr2021 at 22:45, the patient experienced sleeplessness, unwanted thoughts, swollen glands and had songs playing in his head (thinking abnormal). The patient did not receive any treatment for the reported events. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. The clinical outcome of the event sleeplessness, unwanted thoughts, swollen glands and thinking abnormal were not recovered at the time of this report. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Had a swollen spot underarm or armpit; It's painful and I'm not able to bring my arms down or move my arm; Swollen spot on armpit, painful and he is not able to bring his arm down or move his arm.; Swollen spot on armpit, painful and he is not able to bring his arm down or move his arm.; This is a spontaneous report from a contactable consumer. A 40-year- old (age at vaccination) male consumer (patient) reported that he Weight (kg): 107.95, Height (cm): 175 received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, cvoid-19 manufacturer; unspecified, UPC number, expiry date; unknown NDC number; unknown, Reason for no lot number: of COVID-19 Vaccine: Other: LOT#: consumer stated, "I don't have that information now.") via an intramuscular route of administration on 15Jun2021 at 16:00 at dose 2, single in arm left for covid-19 immunisation. Patient's medical history included diabetes, high blood pressure (dates unspecified). Historical vaccine included BNT162B2 via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. No reaction on previous exposure to Vaccine. Concomitant medication included SITAGLIPTIN (Januvia) for diabetes. Consumer received the second dose of the Pfizer-BioNTech COVID-19 Vaccine and had a swollen spot underarm or armpit on 17Jun2021. Reporter seriousness; unspecified. "It's painful and I'm not able to bring my arms down or move my arm." He is asking if this is a normal side effect, how long it will last, and for any recommendations on how to treat it and the pain. Response: Provided response per internal document. Also stated that it may be a swollen lymph node but referred him to a doctor or HCP. Transferring agent stated, "I have here a patient with me, who experienced the side effect with the Pfizer COVID vaccine. So the patient is 40 years old, he got the 2nd dose or the 2nd shot and experienced a swollen spot on his armpit, and this would be in the left arm, he noticed that it's painful and he is not able to bring his arm down or move his arm." When paraphrased the concern with consumer, consumer stated, "Yes." Mailing address, consumer stated, "No." Email address, consumer stated, "No, that I do not want to share that." When probed for the date of vaccination: consumer stated, "It was on Wednesday last week, Tuesday the 15Jun2021)." When probed, when did consumer started experiencing the adverse event: consumer stated, "48 hours after."Other medication: consumer stated, "It's Januvia (not alpha spelled, Further clarification unknown), I don't know the spelling of it." Indication, consumer stated, "For diabetes and blood pressure." Dose of Januvia: consumer stated, "No, actually I don't." Consumer further stated, "I have a question, is Pfizer gonna call me back, check up on me or they have gonna recommendation for me.'' Treatment for swollen spot: consumer stated, "No." When probed if condition is still persisting, consumer stated, "Yes." When probe if condition is improved or worsened, consumer stated, "It's exactly the same, no improvement." Anatomical site: consumer stated, "Left." Route of administration: consumer stated, "Intramuscular." Time of vaccination: consumer stated, "4 o' clock in the afternoon." Facility name: consumer stated, "No, I don't have that information." When probed if consumer underwent for any other vaccination 4 weeks prior to the 1st COVID shot: consumer stated, "No."Reassurance : consumer stated, "No, that's okay, I just want Pfizer to follow up." The outcome of events was not recovered. Information on lot/batch number has been requested.

I have metal in my right shoulder, whole right arm went numb for half a day and was week. Metal in my left foot, whole left let=g is swollen and hurts, saw 3 doctors and they didn't know what to do, one doctor gave me Ibuprofen

2nd vaccine in Friday morning. At night and Saturday whole day staff having bodyache, headache, fever 100.5. Sunday morning a lot better but found a lump in armpit. This morning feeling better no symptom except the lump in armpit which is almost gone but feeling another lump in neck. All lumps happen to be in left side. Got shot on left arm. Called to advise nurse and told to call PCP, which he hasn't called yet.

Left axillary lymphadenopathy pain and swelling extending into the left pectoral muscle.; Left axillary lymphadenopathy pain and swelling extending into the left pectoral muscle.; Left axillary lymphadenopathy pain and swelling extending into the left pectoral muscle.; Left axillary lymphadenopathy pain and swelling extending into the left pectoral muscle.; Date of start of drug: 06Jan2021; Date of start of drug: 06Jan2021; This is a spontaneous report from a contactable Other healthcare professional (patient). A 41-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EJ1685), via an unspecified route of administration on 06Jan2021 09:00 in left arm at single dose for covid-19 immunization. There were no medical history, known allergies or concomitant medications in two weeks. There was no other vaccine in four weeks. The patient previously took the first dose of bnt162b2 on 19Dec2020 12:00 PM in left arm (Batch/lot number: EJ1685) for COVID-19 immunization. The patient experienced left axillary lymphadenopathy pain and swelling extending into the left pectoral muscle on 07Jan2021 07:00. The patient underwent lab tests and procedures which included Covid antibody blood test: negative on 23Dec2020. The events did not resulted in emergency room or physician visit. The events was reported as non-serious. There was no treatment for left axillary lymphadenopathy pain and swelling extending into the left pectoral muscle. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of left axillary lymphadenopathy pain and swelling extending into the left pectoral muscle were not resolved.

Developed DVT in left leg from groin to ankle. Diagnosed on 01/29/2021. Pain, swelling, and difficulty walking lead to emergency room visit, admission to hospital for 2 days.

Shooting pain down left arm, Swollen Lymph node in neck, slight fever, hand pain between ring and middle fingers, Tylenol , appointment with PCP

Trouble breathing with chest pressure; Trouble breathing with chest pressure; Rash on face with swollen fingers; Rash on face with swollen fingers; This is a spontaneous report from a contactable consumer (patient). A 41-years-old male patient received first dose of BNT162B2 (Lot number: 9264), via an unspecified route of administration on 31Jan2021 10:15 at single dose in the left arm for covid-19 immunisation. Medical history included hypertension and penicillin allergy. The patient's concomitant medications were not reported. On 03Feb2021 09:30, the patient experienced rash on face with swollen fingers and trouble breathing with chest pressure. The events result in Emergency room/department or urgent care. The patient did not receive any treatment for the events. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient underwent lab tests and procedures which included Nasal Swab: negative on 03Feb2021. The outcome of the events was recovering. The following information on the lot/batch number has been requested.

Woke up a few days later with terrible lower back pain. I do not recall injuring my back the days prior. I have had back pain before over the years from my job. However, this pain was the worst its been and lasted more than 2 weeks. I saw a chiropractor to help with the symptoms. They have gotten much better, but are still there. I also noticed that my right and left index finger were swollen and stiff in the knuckle closet to my hand.

9 min. after vaccine, both hands began to swell. VS 148/110, HR 110, SO2 98% @ 11AM VS BP 146/114, HR 114, OSat 98% 10:58 AM 25 mg Benadryl per PCP 11:49 AM 25 mg Benadryl given

Swelling at injection site and swelling of hands. Next day migraine, vertigo and rash on right leg. The vertigo has consisted and the rash has spread throughout my whole right leg and now on my left leg.

Second Pfizer COVID vaccine given 2/12/2021. Developed symptoms one day after 2nd Pfizer vaccination with headache, body aches, chills, followed by abdominal pain, vomiting and diarrhea over the next 3 days, then became confused per wife so he came to ED for evaluation on 3/16/2021 and evaluated by me. Also had black stools and vomiting blood. Diagnoses: Septic shock, Gastrointestinal Bleeding with severe blood loss, Hepatitis with Hepatic Encephalopathy, Liver cirrhosis. Admitted to hospital 2/16/2021-discharged 2/21/2021. Since symptoms developed day after vaccination, I am compelled to report.

Pt's wife reports "he had a fever and swollen lymph nodes in his jaw and elbow. the injection site arm was tender to touch"

The patient is a 41 yo male with a history of seasonal allergic rhinitis who experienced DVT and PE temporally related to Pfizer BioNTech COVID vaccine dose #2 receipt. He is a Service Member and reported high levels of baseline activity, including running 10 miles each Saturday. He received vaccine #1 25 JAN 21 (EN5318) without AE. He received dose #2 on 16 FEB 21, (EN6200). He experienced no immediate symptoms suggestive of IgE event. On day 1 he reports feeling cold, mild fatigue but no other symptoms. On day 2 he was baseline. On day 3 he noted numbness, tightness and discomfort to his right calf. On day 4 (Saturday), his usual long run day, he experienced dyspnea and lightheadedness after running 20-30 feet. He states he noted tightness in his calf and instead walked the track while his wife completed her run. He rested day 5. Day 6 he noted significant edema to his calf, which he describes as double normal in size, and iced it. Day 7, he tried to schedule with PCP and based on triage was sent to ER. ER diagnosed R DVT and bilateral PE's. He was admitted overnight, started anticoagulation therapy. He saw hematology, and the workup was negative for other causes.

Patient received vaccine on Thursday. Did not start experiencing adverse reactions until Sunday morning. Patient had swollen lymph nodes from neck to ear canal with fever and pain. He also had hives above the left eye on the eyelid and eye was red and itchy. He also experienced a headache and low grade fever. These reactions have not resolved (as of Monday), however, they are slightly improving.

Patient is 41 years old, male. Alert, oriented X3, clear speech, able to answer to the questions. Underlying medical conditions include Down Syndrome, high cholesterol, and asthma. History of allergic reaction to bethanechol ? swelling, no anaphylactic shock. Denied having allergies to food, other vaccines, or components of COVID-19 vaccine. Patient was tested positive for COVID- 19 in December 2020, was hospitalized for 11 days but was not admitted to ICU or intubated. At 11:50 am, patient received first dose of Pfizer, lot number EW0150, expired on 07/2021 on right deltoid, given by RN. At 12:08, while waiting in observation area, patient reported of tingling and swelling in right hand. EMTs and RN responded. Vial signs were taken every 5 minutes. At 12:08, BP 121/82, Sp02 at 95% room air, HR 110bpm; skin was warm to touch, normal skin color on face and lower extremities. At 12:13 pm, BP 123/82 sitting, HR 107 bpm, 2+, RR 22 res/minute, unlabored, patient was moved to anti-gravity chair. Per sister, patient hasn?t eaten anything this morning. Water and cookies were offered, patient ingested 250 ml and 100% of cookies, patient stated ?I?m feeling a lot better, no more tingling?. Upon assessment, noted significant decreased swelling on right hand, normal skin color, capillary refill <3s bilaterally. At 12:24 pm, BP 121/80, SpO2 92%, RR 20 res/min, unlabored, no acute distress noted. At 12: 28, BP 121/79, HR 104, strong, RR 20 res/min, unlabored, SpO2 95%. At 12:34 pm, BP 121/78, SpO2 95%, HR 102 bpm, RR 20 res/min, unlabored, patient ingested 250 ml of water, denied any discomfort. Patient?s education was provided to patient and his sister, they verbalized understanding. At 12:45 pm, patient left facility, he was accompanied by family members and EMT to their car. Patient was able to walk without assistance, gait was balance.

A small rash approximately 2 cm in diameter appeared on my right anterior thigh about 4 inches above the knee. It started off red and mildly itchy with significant warmth compared to the surrounding area. A day or two later a similar rash appeared on my left wrist and posterior forearm that presented as raised bumps but was similarly itchy. Another day later a similar rash appeared on my right posterior forearm. I then decided to contact a telehealth provider who reviewed via video and decided to prescribe over-the-counter anti-histamine (zyrtec) and a topical ointment of mupirocin. I continued to take the zyrtec and applied the ointment but over the last several days the rash on my leg has increased in size to 20cm x 15 cm with noticeable swelling, itchiness and mild aching pain. Another noteworthy symptom is the area of the original rash on my thigh deepened in color and is now scaly and less itchy.

Tingling in feet and lower calf muscle a few hours after injection. Some calf swelling and light throbbing two days later, continued tingling in feet (pins and needles) now on day 4 after injection and unresolved. Tingling increases after physical activity. Swelling has subsided on day 4. Treated only with rest, compression socks, and keep legs raised when possible, so far. Some swelling of the lymph nodes in groin area.

Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Lymph Node Swelling-Mild, Additional Details: patient felt like his throat was itchy and felt flushed and sweating. he had no other apparent symptoms, we gave him a benadryl and he appeared to be fine

Severe muscle aches and joint pain; shakes and chills; intense night sweats; and large mass under left arm (injection arm). All started the morning after the second dose, and lasted until the following morning. The mass in my armpit is still present and is slightly sore to the touch.

Headache, diarehhia, fatigue, muscle and joint pain, swollen lymph nodes (arm pit on side of injection), chest pain

swollen lymph node behind the jaw on the right side. became noticeable a week after vaccine shot. condition progressed for ~3 days and persists now (a week after first noticed) I have not talked to healthcare professional about this as this is listed as known side effect of COVID vaccine.

Major symptom experienced is severe swelling and pain in right armpit, i.e. lymphedema. Lymphnoid is swollen and painful for 5-7 days shot. Fatigue and overall achiness.

Anaphylaxis treated with EpiPen, Steroids & Benadryl It began as a hives on 04/16 around 8 PM, the morning of 04/17 I had swelling in my eyes, lips and tongue, Along with difficulty swallowing. I was treated with epinephrine on 04/17 around 1 pm and then again on 0/18 around 11 am.

I developed full anaphylaxis within 30 minutes of receiving my Covid-19 vaccine.; dizziness; nausea; inability to swallow; mouth going dry; unable to speak; This is a spontaneous report from a contactable consumer (patient). A 41-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 16Jan2021 12:00 (Lot Number: el3248) as single dose (at the age of 41-years-old) for covid-19 immunisation. Medical history included Heart disease, hyperlipidaemia, hypertension, pituitary adenoma. It was reported that patient received concomitant medications in two weeks prior to the vaccination, no details reported. Patient did not receive other vaccine in four weeks prior to the COVID vaccine. Patient stated that he developed full anaphylaxis within 30 minutes of receiving his Covid-19 vaccine on 16Jan2021 (Adverse event start time reported as 12:00 P.M.). It started with dizziness, then nausea, then inability to swallow and mouth going dry, finally unable to speak. Events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Life threatening illness (immediate risk of death from the event). Patient was treated for the events with epinephrine (EPIPEN) on site by emergency medical services (EMS) and transport to hospital. The patient was not diagnosed with COVID-19 prior to vaccination and had been tested for COVID-19 post vaccination. The patient underwent laboratory tests and procedures which included sars-cov-2 test (Nasal Swab) negative on 11Feb2021. Patient had no known allergies other than the Covid-19 vaccine. Patient recovered from the events on unknown date.

Swollen Lymph node (under right armpit); Fever (up to at least 102); Muscle Aches; Fatigue; Headache (mild); This is a spontaneous report from a contactable consumer (patient). A 41-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 06Apr2021 11:30 (Lot Number: EP-6955) at SINGLE DOSE in Arm Right for covid-19 immunisation. The patient medical history and the concomitant medications were not reported. The patient previously received first dose of bnt162b2 in Arm Right on 18Mar2021 11:00 (Lot Number: EP-6955) as SINGLE DOSE for covid-19 immunisation. The patient experienced Fever (up to at least 102), Muscle Aches, Fatigue, Headache (mild), Swollen Lymph node (under right armpit) from 06Apr2021 11:45 PM. The outcome was Recovering. No treatment received. No covid prior vaccination. No covid tested post vaccination. The events were assessed non-serious. Facility where the most recent COVID-19 vaccine was administered was Other. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No follow up attempts are possible. No further information is expected.

Difficulty breathing and chest pain. Elevated CRP. ON STEROIDS NOW. Suspect potential heart (or peri) inflammation.

PT CALLED STATING LUMP ,BRUISING ON LEFT INNER THIGH. PT NOTICED BRUISING HAS BEEN INCREASING. WE RECOMMENDED TO GO TO ER OR CONVENIENT CARE TO EVALUATE .

Joint aches Dry mouth Soar throat Bump under armpits (right side) Back pain Shivering Tiredness Hedache

Patient presented to ER with flu sx that began after vaccine. Pt reports a constant fever (102 F PTA), constant generalized myalgias and a constant HA that all began on onset. He also reports multiple intermittent diarrhea episodes since onset. Pt c/o constant and non-radiating left foot pain with associated swelling that began yesterday. Left foot pain noted to be gout in ER.

Since my 2nd dose of my Covid shot, I experienced an inflamed lymph node in my left armpit. It lasted about a week and eventually passed. But since that event, I have been experiencing sharp pains on the left side of my body (arms, legs, buttocks), such as shocks, tingling, and numbness in my extremities. If I lift my left arm up, I get the sensation the arm and hand is falling alseep. But it's not the normal falling asleep sensation, more of a shocking pain running to my hands. My buttocks/back thigh area is constantly cramping up.

Rare Diagnosis of Ramsay Hunt Syndrome (Shingles in the inner & outer of the left ear & throat) aka Herpes Zoster Oticus. Bedridden, Extreme fatigue, weight loss, weakness, body aches, pain in throat & ear, lymphodema, severe virtigo, tonsillitis, and permanent hearing lose.

I received the first vaccine without a single side effect. However, the evening after receiving my second dose, I began to get chills, a fever of 101.7, and night sweats. The next morning I woke up to two rashes on my chest. I continued to experience chills, a fever of 102, and the rash now covers my entire body, including my face. The rash is painful, itchy, and bumpy. This is day two. I have swollen lymph nodes in my neck. The urgent care I saw today told me to watch my throat to make sure it doesn't close up.

My brother started with some swelling in the legs/feet, followed by chest pains that led him into a heart attack, followed by cardiac arrest. He was shocked back to life where he lay in a coma. His kidneys stopped functioning followed by his lungs and liver?he was kept alive on life support and dialysis, he died after having 4 more heart attacks back to back on June 4, 2021.

1.Swollen right lymph node, can be seen in a mirror. intense pain right side of neck. Right ear, pain hearing is effected, sometime hear pulse in ear other times ringing. , very bad headache. 2. hard to swallow anything, mouth producing saliva at a rapid rate. 3. nothing over the counter is helping with the fever or body aches, they come and go thru the day/night. 4. body aches/ joints hurt . 5. breathing thru nose hurts right lymph node area. 6. hard to talk. 7. when seeping /lying down, fell like i am chocking on by own Silvia.

Severe swelling of lymph node in left arm pit and minor swelling in other lymph nodes; Severe fatigue; This is a spontaneous report from a contactable consumer (patient). A 41-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot number: EW0176, Expiration date was not reported), via an unspecified route of administration (administered on the left arm) on 15May2021 17:30 (at the age of 41-years-old) as 2nd dose, single dose for COVID-19 immunisation. The patient's medical history was not reported. The patient has no other medications received within 2 weeks of vaccination. Prior to vaccination, the patient has not been diagnosed with COVID-19. The patient didn't receive any other vaccines within 4 weeks prior to COVID vaccine. The patient was previously vaccinated with the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot number: EW0170, Expiration date was not reported), via an unspecified route of administration (administered on the right arm) on 24Apr2021 17:15 (at the age of 41-years-old) for COVID-19 immunisation. The patient experienced severe fatigue on 16May2021 07:00 and severe swelling of lymph node in left arm pit and minor swelling in other lymph nodes on 17May2021 07:00. The events were assessed as non-serious. No treatment was received for the events. Since the vaccination the patient has not been tested for COVID-19. The outcome of the events was recovering.

Pain in both arms and hands. Numb fingertips. Feels like what i would expect carpel tunnel syndrome to feel like. FIngers constantly swollen and tingly. Can't bend fingers at night or when i first wake up. Nothing takes the discomfort or pain away.

I have had NONSTOP ringing in my left ear since April 19th. I have sporadically experienced ringing in my Right ear as well but not nearly to the extent I have in my left ear. I also experienced frequent, daily headaches for about the first month or so after the shot. I also experienced neck/right shoulder stiffness for about 3 weeks following the shot. I continue to wake up on a daily basis with a feeling in my head and ears like I've been listening to loud music or been in a loud sporting event for several hours (on top of the still nonstop/constant ringing in my left ear that will not go away). I have also experienced swelling in my feet and ankles anytime i'm active for an extended period of time

after 2nd dose, severe flu like symptoms for 24-48 hours. After that long lasting issue of knee inflammation and temple region vain inflammation. CRP level is was high in recent blood work.

Pt reports lymph node swelling to left side of neck began 5 days after initial dose of Pfizer vaccine (3/25/2021); reports node was firm and "Pistachio size, swelling to a Pecan size." Pt reports muscle pain, and bilateral lower extremities "extremely hot and sweaty." "extreme fatigue and weakness." Pt was seen by his primary provider at local HCF and was prescribed "2 rounds of antibiotics, Zithromycin and steroid." Dr. also had an ultrasound at another HCF which he reports showed lymph note "reactive and inflamed." Pt continued to follow up with medical provider and waited 3 months to received Pfizer booster vaccine (6/23/2021), which he did receive and subsequently reports reaction is "worse." He reports left side of neck lymph node swelled to "Pecan size" and this time left under arm lymph node palpable "pea size" and he became "loopy;" "not fully present" described it as driving as in a fog "dissociated." Extreme fatigue and weakness continue. Pt reports he then again saw his primary medical provider and was prescribed more antibiotics (Rocefin I.M.) and steroids. He is being referred to an ENT MD and infectious disease MD for follow up. Pt reports he tested multiple times in the past for COVID-19 via rapid testing (No PCR confirmatory test done), he reports he never tested positive for COVID-19 but reports he had all the symptoms including loss of taste and smell back in July 2020.

Fatigue, ache, Extreme swelling of the lips. 4 occurrences so far covering all 4 quadrants randomly. Numbness, tingling, itchy sensation. Last episode involved swelling of the cheek and eye on same side as lip. Chest and back tightness

Dx: Angioedema, pruritus Tx: Prednizone, Clairitin, ice Results: Swelling not going down with treatment, itching is now gone.

Day 1-2 post injection: Severe body aches (whole body - hurt to even try to pick up cell phone), visibly swollen left armpit painful to touch and with arm movement, severe rigors, fever ~101, rapid temperature changes (burning up to freezing), sweating, headache, nauseousness, dizziness, exhaustion/low energy, no appetite, brain fog Day 3: above started to slowly subside Majority of symptoms have gone away. Still get nauseous and dizzy at some point every day. Low energy, lethargic still, no real appetite, still have brain fog.

10 days after the second dose experienced high fever, hives and angioedema according to pcp. swelling was in my face and salivary glands, fever much worse at night.; 10 days after the second dose experienced high fever, hives and angioedema according to pcp. swelling was in my face and salivary glands, fever much worse at night.; 10 days after the second dose experienced high fever, hives and angioedema according to pcp. swelling was in my face and salivary glands, fever much worse at night.; 10 days after the second dose experienced high fever, hives and angioedema according to pcp. swelling was in my face and salivary glands, fever much worse at night.; 10 days after the second dose experienced high fever, hives and angioedema according to pcp. swelling was in my face and salivary glands, fever much worse at night.; This is a spontaneous report from a non-contactable consumer (patient). A 41-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0196), second dose via an unspecified route of administration, administered in left arm on an unspecified date in Jun2021 at 09:30 (at the age of 41-year-old), as a single for COVID-19 immunisation at pharmacy or drug store. No relevant medical history and concurrent conditions. No known allergies were reported. The patient's concomitant medications were not reported. Historical vaccine given to patient was bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0187), first dose via an unspecified route of administration, administered in left arm on an unspecified date in May2021 at 09:30 (at the age of 41-year-old), as a single for COVID-19 immunisation at pharmacy or drug store. No relevant past drug history. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not diagnose with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. Reported Event: 10 days after the second dose on 27Jun2021 at 02:00 the patient experienced high fever, hives, and angioedema according to pcp. swelling was in my face and salivary glands, fever much worse at night. No treatment was received for the event. The events had not resulted in for death, life-threatening, prolonged hospitalisation, disabling/incapacitating or Congenital anomaly/birth defect. The reporter reported events as non-serious. Adverse events result in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 28Jun2021 (Nasal Swab). The outcome of events was reported as resolving and outcome of the event high fever was reported as not resolved. No follow-up attempts are possible. No further information is expected.

Started with shoulder and armpit aches (~15 hours after receiving the shot). Progressed into strong pain in the shoulder and armpit. These symptoms kept me up all night. Then progressed into large golf-ball-size swelling in the left armpit which lasted several days. I took ibuprofen for the swelling, but didn't seem to do much. After a few days, the swelling started to reduce.

Swelling in calves; Tingling/pins and needles in feet and lower calves; Swollen lymph nodes; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 8734) via an unspecified route of administration in the left arm on 29Mar2021 at 18:15 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Medical history included meniere's disease and anxiety. The patient did not have any allergies to food, medications, or other products. Concomitant medication included hydrochlorothiazide, triamterene (TRIAMTERENE HCTZ). 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 29Mar2021 at 22:00, 4 hours after injection, the patient started feeling tingling in feet (pins and needles) and lower calves, the patient had swelling in calves two days later on 31Mar2021. Swelling subsided but tingling in feet persisted a week later. It was accompanied with swollen lymph nodes in groin area on an unknown date in Mar2021. Tingling increased with physical activity such as walking or temperature changes (hot shower etc). The events resulted in doctor or other healthcare professional office or clinic visit. The patient did not receive any treatment for the events. The clinical outcome of the event swelling in calves (calf swelling) was recovered on an unknown date in 2021. The clinical outcome of the events swollen lymph nodes and tingling in feet and lower claves were not recovered at the time of this report. No follow-up attempts are needed. No further information is expected.

Allergic edema; Hearing loss; swelling at injection site after covid vaccination; vertigo; swelling of hand; high blood pressure; rash on legs; This is a solicited report FACILITATED COLLECT based on the information received by Pfizer from biopharmaceutical company (MFR Control No. # 21K-163-3802407-00) from a non-contactable consumer (patient) A 41-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 single intramuscular on 04Mar2021 (Batch/Lot number was not reported) at age of 41 years for covid-19 immunisation; adalimumab (HUMIRA), via subcutaneous from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at 40 mg (40 mg,1 in 7 D) for ankylosing spondylitis . Medical history included asthma from an unknown date and unknown if ongoing. Concomitant medication(s) included omalizumab (XOLAIR) taken for an unspecified indication, start and stop date were not reported. The patient experienced hearing loss (medically significant) on Mar2021 with outcome of not recovered , swelling at injection site after covid vaccination (non-serious) on Mar2021 with outcome of recovering , vertigo (non-serious) on Mar2021 with outcome of not recovered , swelling of hand (non-serious) on Mar2021 with outcome of recovering , high blood pressure (non-serious) on Mar2021 with outcome of recovering , rash on legs (non-serious) on Mar2021 with outcome of unknown , allergy caused eye to swell (coded as allergic oedema) (non-serious) on an unspecified date with outcome of recovering. The patient underwent lab tests and procedures which included blood pressure measurement: blood pressure measurement: high on 2021 . The clinical course was reported as follows: The patient had a relevant medical history of asthma.On an unknown date, the patient experienced allergy caused eye to swell. In March 2021, the patient experienced hearing loss, swelling at injection site after Covid vaccination, vertigo, swelling of hand, high blood pressure and rash on legs. Pfizer BioNTech Covid-19 vaccine was also considered suspect.It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On 04Mar2021, patient received first dose COVID-19 Vaccine manufactured by Pfizer. On 04Mar2021, after taking Covid vaccine patient had swelling at the injection site, high blood pressure, hand swelling, rash on legs, hearing loss and vertigo. He had an allergy that caused eye to swell.The action taken with Humira was unknown The reporter stated that there is no reasonable possibility that the events are related to HUMIRA .While for Pfizer Biontech Covid-19 Vaccine reporter's causality was reported as probable for Hearing loss and vertigo and unknown for the other events. AbbVie's causality for all events vs Humira was reported as follows: No reasonable possibility The reporter's assessment of the causal relationship of all the events except for hearing loss and vertigo with the Pfizer 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 No follow up attempts are possible. Information about lot/batch number cannot be obtained; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events deafness, vaccination site swelling, vertigo, peripheral swelling, hypertension, rash, and allergic edema and the suspect drugs. 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.

A small triangular patch was still swollen under my left eye; a racing heart; severe headache.; Dizzy moments,; feelings of clumsiness; Chills; pain in right knee; pain in left shoulder; mouth and left side of face felt numb; mouth and left side of face started swelling; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE: Lot Number: ER8737) via an unspecified route of administration in the arm left on 03Apr2021 at 09:15 (at the age of 41-year-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism and general allergies. Patient had birch allergy (as child) and had reactions (fever) after vaccines as a young child. The patient did not have any concomitant medications. 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 09:45, the patient experienced numbness, swelling face, dizziness, clumsiness, chills, pain in knee and pain in shoulder and at 3:00 he experienced severe headache. On 04Apr2021, the patient experienced a racing heart and on 05Apr2021, the patient experienced eye swelling. 30 minutes after the vaccine, the patient noticed his mouth and left side of face felt numb and started to swell as he was driving. The sensation felt similar to dental work. It seemed to improve after 1-2 hours (went for a walk and started to do yard work). General numbness and swelling lasted all day. On day 2, a small triangular patch was still swollen under his left eye. In the night (of day1) he woke up at 3:00 with a racing heart and severe headache and had a restless night thereafter (which is highly uncommon). Heart beat went back to normal after waking up and walking outside. Other less severe and persistent symptoms included dizzy moments, feelings of clumsiness (fell playing sports with son, missed a stair), chills, pain in right knee, pain in left shoulder, 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. The clinical outcome of the event headache, dizziness, clumsiness, chills, pain in knee, pain in shoulder and eye swelling was recovering at the time of this report. The clinical outcome of the event numbness and swelling face was recovered on 03Apr2021 and racing heart recovered on 04Apr2021. No follow-up attempts are needed. No further information is expected.

Herpes virus onset and flare up with Bell's Palsy; inflammation of cranial nerve 7; Herpes virus onset and flare up with Bell's Palsy; inflammation of cranial nerve 7; Herpes virus onset and flare up with Bell's Palsy; inflammation of cranial nerve 7; This is a spontaneous report from a contactable other hcp. A 41-years-old male patient received second dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported) via intramuscular route of administration in Arm Left on 04Apr2021 12:00(age at vaccination:41 Years) as DOSE 2, SINGLE for COVID-19 immunization. Patient didn't received other vaccines within 4 weeks prior to vaccination and patient didn't received within 2 weeks prior to vaccination. Medical history included gluten sensitivity from an unknown date and unknown if ongoing, food allergy was corn and dairy allergy from an unknown date and unknown if ongoing, papilloma viral infection from an unknown date and unknown if ongoing, epidermolysis bullosa from an unknown date and unknown if ongoing. Concomitant medication were not reported. The patient previously received first dose of bnt162b2(BNT162B2, Solution for injection, lot no: unknown) via intramuscular route of the administration in Arm left on 14Mar2021 12:00 (age at vaccination:41 Years) as DOSE 1, SINGLE for COVID-19 immunization. The patient experienced herpes virus onset and flare up with bell's palsy; inflammation of cranial nerve 7 on 07Jul2021. The Patient didn't had COVID-19 prior to vaccination patient was tested to COVID-19 to post vaccination. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 25May2021 Nasal Swab. Patient had disability for the events. Therapeutic measures were taken as a result of herpes virus onset and flare up with bell's palsy; inflammation of cranial nerve 7 was antivirals and steroids. The outcome of the events bell's palsy, cranial nerve infection, herpes virus infection was recovering. Information on the lot/batch number has been requested.; Sender's Comments: Based on the description given in the narrative, there is reasonable possibility of causal association between the events Bell's palsy, Cranial Nerve Palsy, Herpes Viru infection and the suspect BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer drug 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.

Migraine for 2 days since few ours after the shot and left lymph nodes tenderness and swollen. The migraine is gone after 2 days but the lymph nodes still swollen and tender. I never any reaction so ever and I very healthy person.

Swelling in left armpit and it is painful; Continues mild pain and feels heavy/left arm is feeling heavy; Swelling in left armpit and it is painful; soreness at the left arm where took vaccine; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0179) via an unspecified route of administration in the left arm on 02May2021 at 08:30 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Patient medical history was provided as no. Patient past drug history was provided as no. The patient did not receive any medication within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the left arm on 11Apr2021 at 08:30 (at the age of 41-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 COVID vaccine. On 03May2021 at 11:00, the patient experienced swelling in left armpit and it was painful. The patient also stated that left arm was heavy and there was soreness at the left arm where the patient had vaccine. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events swelling in left armpit, it was painful/armpit pain, and left arm was heavy and there was soreness at the left arm were not recovered at the time of this report. No follow-up attempts are needed. No further information is expected.

abnormally enlarged bilateral (left greater than right) painful axillary lymph nodes; abnormally enlarged bilateral (left greater than right) painful axillary lymph nodes; This is a spontaneous report from a contactable physician (patient). A 42-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number EL3246) via an unspecified route of administration on left arm on 08Jan2021 07:30 at a single dose for covid-19 immunization. The patient got allergies to fluoroquinolones and dairy (milk protein allergy). Prior to vaccination, the patient did not diagnose with COVID 19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included famotidine and cetirizine hydrochloride (ZYRTEC). The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number EH9899) on left arm on 19Dec2020 01:30 PM for covid-19 immunization. The patient experienced abnormally enlarged bilateral (left greater than right) painful axillary lymph nodes on 10Jan2021 16:00. It began about 48hrs after 2nd shot and still persisted to 5 days later. The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient has not been tested for COVID 19. The patient received Ibuprofen to treat the events. The outcome of the events was not recovered.

He feels tense and he there's a bump on the nerves on between his neck and shoulder, and when you press on it hurts.

Minor swollen lymph nodes were first observed on day 3 pm at the patient?s neck same side as the injection (left arm). Since then severe swollen lymph nodes have been developing on multiple areas from shoulder, along the neck, to face/back of ear, same side (left) of the shot. Sizes of some areas are more than 1 square inch. Other symptoms including, migrate, mild fever and fatigue.

Per Client received first COVID 19 vaccine on 1/23/2021 and had mild symptoms, fatigue and arm soreness. Per Client after receiving the second COVID 19 vaccine on 2/12/2021 started having symptoms of swollen, painful and tender Lymphnode in left armpit area, on 2/14/2021 at 0830. Per Client having difficulty lowering left arm completely. Client also C/O having sever achy pain over the left Trapezius muscle, makingit difficulty to drive. Per Client has been taking Ibuprofen for pain and placed a called to PCP for follow up only. Per Client pain listed above has not resolved as of today.

Severe Anaphylaxis onset at 3:00am. Epinephrine administered at home. Transported to ER. BP 80/40 at admission. 2nd Epinephrine administered at ER. IV fluids. BP recovered and discharged at 7:30am. Prescribed Prednisone 20mg, Famotidine 20mg, and Cetirizine 10mg.

swelling; red spots; tenderness on my right big toe and the toe next to it; This is a spontaneous report from a contactable consumer (patient). A 42-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Lot #: EL3247) via an unspecified route of administration on 19Jan2021 (at the age of 42-years-old) as a single dose for COVID-19 immunization. Medical history was reported as none. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not have any known allergies. The patient did not receive any other medications within two weeks prior to the vaccination and did not receive any other vaccines within four weeks prior to the vaccination. On 30Jan2021 the patient experienced swelling, red spots and tenderness on my right big toe and the toe next to it. The clinical course was reported as follows: "two weeks after my COVID-19 vaccination I noticed swelling, red spots, and tenderness on my right big toe and the toe next to it. I visited my podiatrist who recommended NSAIDs for a week. Today, my sister in law who is a nurse said it looked like COVID toes. When I googled an image of COVID toes, the spots looked identical to my own." The adverse events required a physician office visit. The patient received treatment for the events which included NSAIDs. The clinical outcomes of the events swelling, red spots and tenderness on my right big toe and the toe next to it were all not recovered/not resolved. It was also reported that since the vaccination, the patient had not been tested for COVID-19.

Severe muscle/joint pain/swelling in the middle of my left foot. Unable to walk in the morning. Slowly relieved over the next 36 hours. Soreness at injection site. Relieved within 24 hrs of injection.

Intense flu symptoms for three days, to include fever chills, aches, swelling of face and neck. Subsequent to flu, low oxygen rates of 82-91, low resting heart rate of 48-54, extreme exhaustion, swelling of face and neck. General weakness.

Swollen, painful to touch, lymph node - cervical - left side - just above clavicle. I have not sought treatment, but wanted to report.

Started was a very cramped stomach and then the rest followed. Whole body turned red including eyes. Upset stomach with vomiting and diarrhea. Body was shaking and didn?t have a fever. Skin felt like it was burning whole body felt swollen. Started around 2:30am with the cramping. It woke me up. Once I got up everything came so fast. Was rushed to hospital where I was admitted very quickly. I was blacking out on the drive there and blacked out while in their care. This was from one dose of Pfizer vaccine for Covid. I was put on a GI, Allergy, and steroid medications. I was hooked up to an IV and 3 drugs were injected. I passed out numerous times but was discharged at 5am.

fever (over 101), chills, muscle aches, swelling in left armpit, headaches lasted about 2 days. swelling in armpit and headaches lasted another day

Has urticarial swelling of upper face, periorbital areas and upper back; no wheezing or throat swelling

I got my 2nd shot on March 26th. On Monday March 29th 6:00pm, my elbows started to itch and develop hives/rashes. Then my knees and then foot and hands by the night. It was burning and itching and it swelled up a little. Oddly the itchiness and redness goes away and then comes. Taking Allegra does help but its not making the symptoms go away.

Lymph node in neck became swollen and painful. Mild fever for at least 2 days. Injection site became a red knot that hurt to touch. Injection site was swollen and turned to a large bruise. Lymph node under left arm swollen. Fatigue.

Two Enlarged lymph nodes above the collar bone and neck on the same side as the vaccine occurred (right). Noticed the first enlarged lymph node above my collar bone approx. 3 weeks after my first shot. 24 hours After my second shot that same node enlarged further and I noticed an additional enlarged lymph node approximately 1 inc above the first.

SWOLLEN LYMPH NODE/KNOT UNDER LEFT ARM. IT APPEARED SEVERAL DAYS AFTER INJECTION. SORE TO THE TOUCH.

I had a strange feeling in the left side of my face that I wasn't sure if it was a reaction or not. It happened within the first 15 minutes but did not last more than 30 minutes. I did not experience anything else until the first evening when my arm was very sore. The next day my arm was more sore and I had a mild circular red mark around the injection site and the arm was much harder on that side. I also felt a little in my back and neck. By the second day in the evening the only thing I felt was pain in the arm which eventually traveled into my armpit by day 3. It wasn't until day 5 that all the pain was completely gone. I may have experienced fatigue the first two days also.

Pfizer-BioNTech COVID-19 Vaccine EUA: patient presents to emergency department (ED) from urgent care (UC) reporting six days of vomiting, fatigue, shortness of breath, dizziness, constipation, and polyuria starting one day after receiving vaccination. Initial vital signs blood pressure 127/96 mmHg, heart rate 119 beats per minute, temperature 35.9 degrees Celsius, respiratory rate 18 breaths per minute, oxygen saturation 97% on room air. Patient diagnosed with new adult-onset diabetes, diabetic ketoacidosis, and acute kidney injury and admitted to the hospital. Administered intravenous fluids and insulin with improvement in symptoms and lab values. Currently hospitalized.

Approximately one week after my second dose my right leg began swelling. For three weeks after the swelling began it would get better than get worse. On Tuesday, March 30, 2021 my entire leg swelled to twice its normal size at which time I went to the emergency room and a blood clot was diagnosed in my right leg. I completed a multitude of tests and bloodwork with a hematologist and there are no factors or reasons they can identify as to why I developed a blood clot.

Joints became sore and right foot very tight the night following shot (4/3/2021). Pain continued to build following day (4/3/2021 aka Easter). By 9:30 PM on the night of 4/3 the large right toe had swollen and was unable to move. By the morning of 4/4/2021 no pressure could be placed on the right foot without extreme pain. Pain reached highest pain by 4/7/2021 and has slowly tapered but remains. Swelling has reduced to point where a lose shoe can be placed over foot and some walking can occur with effort. Joint pain continues in shoulders, knees and hips. I become winded after walking only a few hundred feet. (typically jog 2 miles/day and walk an additional 5 miles)

anaphylaxis. throat closing, tongue tingling, couldn't breathe within a few minutes of injection epipen and Benadryl given on site, sent to hospital for observation, treatment with allergy medications and steroids for five days after. Observed in hospital for four hours. Advised by primary care doctor not to get second dose or any other covid vaccines due to reaction.

Patient started 2 days after vaccine with shortness of breath and fever/chills. He says he was unable to get out of bed for 24 hours. He said the rest of the week he didn't feel quite right. A week after the vaccine he started with red capillary veins popping up all over his legs. By Saturday his legs were purple and swollen. He has multiple tests run at the hospital. They doctor believes it is vasculitis that has resulted from patient getting the covid vaccine.

All symptoms ongoing and have not stopped Bi-lateral tinnitus (high pitched ringing) Ear Ache both ears Swollen Lymph glands in neck Fatigue Body Aches

Headache. Neck Pain. Drowsy. Fatigue. Lump under right arm pit. Consistent Coughing. Runny Nose. Sneezing.

Right axillary lymphadenopathy still present. Right arm pain still present. Bilateral hand rash still present.

Swelling in left armpit lymph node.Swelling and water retention in surrounding area; 1st dose administered on 28Jan2021 and 2nd dose administered on 14Feb2021; This is a spontaneous report from a contactable consumer (patient). A 42-years-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL9264, expiry date was unknown) via an unknown route in the left arm on 14Feb2021, at 07:45 AM, (at the age of 42 years) as a single dose for COVID-19 immunisation. Patient did not have medical history. The patient had no allergies. Concomitant medications included curcuma longa rhizome, piper nigrum fruit (TURMERIC) and chondroitin (within 2 weeks of the vaccination). Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL9262, expiry date was unknown) via an unknown route in the left arm on 28Jan2021 at 05:00 PM (at the age of 41 years) as a single dose for COVID-19 immunization. On 02Feb2021, the patient had covid test (covid test type post vaccination: Nasal Swab) and result was negative. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 15Feb2021 at 04:00 AM the patient experienced swelling in left armpit lymph node, swelling and water retention in surrounding area. Patient did not receive any treatment for the adverse event. 1st dose administered on 28Jan2021 and 2nd dose administered on 14Feb2021 to patient, which is Inappropriate schedule of vaccine administered. The outcome of the event swelling in left armpit lymph node, swelling and water retention in surrounding area was recovering. Information about batch number has been requested.

3 hours after injection, felt like hands, arms, and legs were swelling (but they weren't), and had a total brain fog, felt like I was either on drugs or had alzheimers. Paced around my house and backyard in a fog, confused, not clear of thought. Had a hard time spelling words in emails. Symptoms went away within 45-60 minutes and did not return. Since that time felt a little tired but nothing serious. Today I feel completely normal.

Patient presenting with axillary lymphadenopathy of the left armpit that started either 4/16/2021 or 4/17/2021

Swollen/painful lymph node in left groin - started day 3 (4/16), lasted 10 days, still 10% swollen/no pain as of day 22 (5/5). Rash (mild/light pink) around left groin lymph node, creates a semi-circle perimeter 4 inch radius from lymph node - started day 10 (4/23), still persists as of day 22 (5/5)

Delayed Inguinal lymph swelling that then had a warm rash covering inguinal area and crease on same side(ipsilateral) as the given upper arm vaccination. Persisting rash still after 3 weeks and 2nd dose NOT GIVEN.

Joint pain in shoulder; It felt like bursitis when he had it before on another part of his shoulder; his arm was paralyzed and was hurting a lot/arm was painful; It is a sharp, burning, stabbing pain; Arm was paralyzed; Muscle pain at the deltoid/intense muscle pain" in the deltoid muscle; Injection was too low/Injection point was a little lower than expected; he had shoulder pain; This is a spontaneous report from a contactable consumer. A 42-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration on 16Apr2021 (Batch/Lot number was not reported) as SINGLE DOSE (at age of 42 year old )for covid-19 immunisation. Medical history included he's had bursitis previously and that the symptoms lasted 6 weeks to 6 months (reported both lengths of time, unsure which is correct duration). The patient's concomitant medications were not reported. On 16Apr2021, the patient experienced he had shoulder pain and the injection was too low/Injection point was a little lower than expected. On 17Apr2021, the patient experienced muscle pain at the deltoid/intense muscle pain in the deltoid muscle. On 20Apr2021, the patient experienced arm was paralyzed , Joint pain in shoulder, It felt like bursitis when he had it before on another part of his shoulder, his arm was paralyzed and was hurting a lot/arm was painful, It is a sharp, burning, stabbing pain.Outcome of the events Muscle pain at the deltoid/intense muscle pain" in the deltoid muscle, Joint pain in shoulder, his arm was paralyzed and was hurting a lot/arm was painful, he had shoulder pain was not recovered. Outcome of Arm was paralyzed, Injection was too low/Injection point was a little lower than expected, It felt like bursitis when he had it before on another part of his shoulder, It is a sharp, burning, stabbing pain was unknown. Information about lot/batch number has been requested.

Almost 3 weeks ago I received my 2nd Pfizer vaccination for COVID. I had some swelling in my armpit. A hard bump also appeared between my right leg and crotch. My armpit feels 100%, but the bump has not gone away. Concerned, I wanted to get it checked out. I set up an appointment for the earliest possible, 6-29-2021.

Presented to ED on 5/10/2021 with abdominal pain, nausea, vomiting, marked leukocytosis of 30K with left shift. Admission screening PCR for COVID-19 Positive. No known history of COVID-19 in the past, no known contact with a person positive for COVID-19

Guillian-Barre syndrome; This is a spontaneous report received from a contactable consumer (patient). A 42-year-old male patient received first dose of BNT162B2 (Lot Number: EP6955) via an unspecified route of administration, administered in left arm on 24Mar2021 at 15:30 at age of 42-year-old as single dose, and second dose of BNT162B2 (Lot Number: ER8735) via an unspecified route of administration, administered in left arm on 15Apr2021 at 15:30 at age of 42-year-old as single dose for covid-19 immunisation. Medical history was not reported. There were none other medications in two weeks, no other medications in four weeks. No COVID prior vaccination, no COVID tested post vaccination. The patient experienced guillian-barre syndrome on 19Apr2021 at 06:00. The event resulted in doctor or other healthcare professional office/clinic visit. No treatment received. The outcome of event was recovering. Information on Lot/Batch number was available. Additional information has been requested.

Pt first began to notice left leg "stiffness" after receiving his first COVID vaccine (Phizer) several weeks ago. Pt states that after receiving his 2nd dose on 05/06, he noticed his leg stiffness got significantly worse. He tells me that he tried to "push through the pain" and mow his lawn but had to stop d/t severe cramping of the LLE and pelvis. He states he rested his leg and went to bed, and when he woke up he noticed that his left leg was severely swollen. Pt decided to take 3 days off work to continue to rest the leg, but ultimately came in for evaluation at the suggestion of his coworkers. Pt denies fever, chills, chest pain, or SOB. He denies history of smoking, prior clotting, long car travel, air travel, leg injury, or recent surgery. On exam, the left lower extremity is significantly swollen, erythematous, and hot to the touch. Physical exam otherwise unremarkable. Will admit to the hospitalist service for further medical management. ED Course: Hypertensive with BP 170/93. Initial workup significant for WBC 13, K 3.3, glucose 159. CT chest/a/p with findings suggestive of multiple PE's of the left and right lower lobes as well as extensive LLE DVT extending slightly into the IVC. Trop <0.03. BNP 66. ECG shows sinus tachycardia.

Most, if not all, of my pain from my lower back surgery was gone. 1 week after the shot I started having pain in my left sciatic nerve again. It isn't as bad as it was but definitely painful. The upper back pain has came back and isn't terrible painful but is uncomfortable. Pain in most of my joints: knees, elbow, fingers... Most noticeable in my knees. (I weigh 150 pounds). I have been tired a lot. I did not have any issues with the bells palsy in my face. I received allergy shots for years and stopped getting them when I had surgery. After the surgery, I started getting the allergy shots again, it made me swell and my back pains were increased because of it. So I stopped getting them. So the issue may be that the COVID shot is making me swell.

feet were numb, they felt like they were asleep, which progressed from his feet up his legs to his stomach and chest area, then to arms and hands/ diagnosed with Guillain-Barre syndrome; This is a spontaneous report from a contactable consumer (patient). A 42-year-old male patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, Lot Number: ER8735), via an unspecified route of administration, administered in the left arm on 15Apr2021 at 15:30 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had not received other vaccinations on the same dates as when he got the Pfizer COVID-19 vaccine injections, or in the four weeks prior. The patient also stated that he has not started new medications. The patient previously received the first dose of BNT162B2 on 24Mar2021 (lot number: EP6955) at 15:30 in his left arm for COVID-19 immunization. On 18Apr2021, 3 days after the patient got his second dose his feet were numb, they felt like they were asleep, which progressed from his feet up his legs to his stomach and chest area, then to arms and hands. It has stayed the same since it got to his arms. He says he is probably on day 22 at the time of the report. He says he got to see a neurologist and he was diagnosed with Guillain-Barre syndrome. The patient reported that there has been no treatment and was told that it has to run its course. The patient was not hospitalized for the event. He says he just wanted to report that and that he was also curious if others have been reporting that. He says he has never experienced this before, he was very healthy and never had any symptoms with vaccines before, this is all brand new to him. The outcome of the event was not recovered.

This is not very clear that the Pfizer vaccine is actually the cause of the patient's Cerebral thrombosis, however, we are reporting to VAERS as this is a unique first case where the patient has Dural venous thrombosis within 2 weeks period of getting 2nd dose of Pfizer vaccine. 05/25/2021: CT HEAD/BRAIN W/ IV CONTRAST showed dural venous sinus thrombosis involving the superior sagittal sinus, right transverse, and sigmoid sinuses, extending into the proximal right internal jugular vein.

60 hours after the second injection hives began to appear on hands starting on the thumbs and pointer fingers of both hands. 6 hours later hives spread to cover the whole hands and started above the beltline on the small of the back. 4 hours later hives had spread up the back reaching around the ribs to the chest in lines. 6 hours later the rash was starting on the head, forearms, feet, shins, neck, chest, shoulders, and hands were swollen and painful to open and close. 88 hours after the injection medical attention was sought, the PA recommended use of Benadryl Over the counter capsules taken 1X per day before bed and Claritin capsules taken 1X per day in the morning. as of 6 days after the second vaccine the hives have stopped spreading and the swelling in the hands and feet has gone down. Hives are still present but not as inflamed.

Eye and facial swelling; Eye and facial swelling; This is a spontaneous report from a contactable consumer (patient). A 42-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported) via an unspecified route of administration, administered in Arm Right on 07Mar2021 as FIRST DOSE, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient had not received any other vaccines within 4 weeks of COVID vaccine. The patient previously took clindamycin and experienced drug hypersensitivity. On 07Mar2021 16:30, the patient experienced eye and facial swelling. The patient has not received any treatment for adverse events. The patient was not diagnosed prior and since the vaccination with COVID-19. The outcome of events was not recovered. No follow-up attempts are possible; information about lot/batch number cannot been obtained.

Secondary cellulitis; Onset tightness left forearm with swelling; Onset tightness left forearm with swelling/Left arm circumference 2.5 inch more than right; Shotty lymph nodes; mild left supraclavicular swelling/Axillary swelling/soft tissues swelling; This is a spontaneous report from a contactable physician. A male patient of an unspecified age received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number and expiry date unknown), intramuscular, administered in the left arm on 29Mar2021 as a single dose for COVID-19 immunization. Medical history included allergies to latex and pineapple, seasonal allergies, thrombocytopenia and chronic prostatitis (reported as chr prostatitis) from an unknown date and unknown if ongoing. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included amitriptyline hydrochloride (ELAVIL); marijuana and meloxicam (manufacturer unknown), all taken for an unspecified indication, start and stop date were not reported. The patient previously received the first dose of bnt162b2 on 08Mar2021 (lot number and expiry date unknown), intramuscular on the left arm for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has not been tested for COVID-19. On 19May2021, the patient experienced the onset of tightness left forearm with swelling. The left arm circumference was 2.5 inch more than right with mild left supraclavicular swelling. The patient went to the ER and had an ultrasound of left upper extremity including subclavian and cephalic veins which showed no DVT, MRA showed no arterial clots, CT with contrast showed axillary swelling, shotty lymph nodes, soft tissues swelling, no tumor nor clots. The patient was administered with cefadroxil as he may have secondary cellulitis. The patient had not recovered from the events. Information on the lot/batch number has been requested.; Sender's Comments: The causal association between the event secondary cellulitis ad the suspect drug BNT162B2 cannot be totally excluded based on a temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated a part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory authorities, Ethics committees, and Investigators, as appropriate.

I had an acute anaphylactic reaction to a yellow jacket sting. Within 20 minutes of the sting, my whole body was swollen and airways began to constrict. I received epinephrine, type 1 and 2 antihistamines, and steroids, and the symptoms resolved. I am reporting this because I was stung by a yellow jacket in the same location a year earlier (pre-vaccine) and had no reaction. I had never had an anaphylactic reaction. Clearly, other factors could have caused the new response to what appears to be the same stimulus, but receiving an MRNA vaccine designed to stimulate immune response seems like a suspect worth investigating.

Slow swelling of lymph nodes in neck following by sinus congestion, headaches, and TMJ. Ears became full with fluid and pressure then extreme tinnitus developed. My regular doctor prescribed 2 different antibiotics which had zero effect on tinnitus. It is almost 12 weeks after the tinnitus began and I still have ringing in the ears. It has reduced to 50% over the 3 months. I have never experienced this symptom previously and it has become the worst health event in my life. I have not been exposed to any loud sounds. I have been to see 2 ENTs and they believe the condition is permanent. I had a CT scan completed and it shows there are no issues. I am hoping it is inflammation and will go away over time. I am currently taking Prednisone and hoping it reduces any possible inflammation. The ringing and popping noises in my ears need to stop ASAP.

For 1st vaccine- I experienced first vaccine- one week later I got sick for 15 days, symptoms like I had Covid, body aches, chills. For 2nd vaccine- after one week I experienced had excruciating headaches and shakiness that do not go away. I take Tylenol for pain and as a result have upset stomach. I went to see my PCP who performed exams, lab work, x-rays, CT scan of the head, CT scan of the abdomen and my doctor does not find anything wrong for me. To this day I continue wit the headaches that do not go away. I do not feel well to do my daily living activities and I get anxiety. I feel very tense and frustrated due to my symptoms. I do not have the lot # for my vaccines to provide.

Lymph Node swelling in Armpit and pectoral region of left arm, cause pain discomfort, a large bump, and causing arm to not being able to drop fully to side of torso. Just about 2 weeks to finally be able to move correctly, without pain and discomfort.

Left armpit is swollen (lymph node the size of a small orange) and right armpit also swollen but not as severe as the right.

Site: Pain at Injection Site-Mild, Site: Swelling at Injection Site-Medium, Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Shakiness-Mild, Systemic: Tachycardia-Mild, Additional Details: patient describes shakiness, anxiety, swelling under and around arm, and pain. Reports taking 600 mg ibuprofen on tues and wed (600 mg po bid on Tues and Wed) "went away a bit and came back a little bit"

Myocarditis; Chest pain; high fever; Inflamed lymph nodes; This is a spontaneous report from a contactable other hcp.A male patient of 43 years old received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 26Jan2021 13:00 (Batch/Lot Number: EL3249) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included splenectomy from 1995 to an unknown date, mildly high cholesterol.He gets the Pneumovax because he is immunocompromised and gets kind of sick feeling. He gets it every 5 years and does get a fever afterwards; he got the Flu vaccine in Sep2020 or early Oct2020.he got the Flu vaccine in Sep2020 or early Oct2020.The patient's concomitant medications were not reported. Patient previously received the first dose of bnt162b2 on 05Jan2021 for covid-19 immunization. The patient experienced myocarditis in Mar2021 with outcome of recovered, high fever on 27Jan2021 with outcome of recovered, inflamed lymph nodes on 27Jan2021 with outcome of recovering, chest pain in Mar2021 with outcome of unknown. Stated that he received his 2nd dose on 26Jan2021 and had really inflamed lymph nodes and a very high fever. He didn't have chest pain until 4-6 weeks later; around Mar2021. Stated that his lymph nodes were really inflamed for about 2 months after the 2nd dose. They were so inflamed that he said he had a hard time turning his head. States that the other day he was saying that his lymph nodes were still inflamed. He had a very high fever for about 2 days. States this was concerning because they were told that if he had a high fever he would need antibiotics right away because of his splenectomy. He was having chest pain every night when he laid down, but then it got severe, and normally he doesn't complain of anything. He went to the doctor the next day and had an EKG and blood work. Caller states that she doesn't remember the date this occurred, only that it was probably sometime in Mar2021. States that they weren't worried about anything on the EKG, and he had mildly high cholesterol. His doctor put him on Lipitor and Prilosec OTC, but now they are questioning whether he needs to be on them. Stated that about a month later it came out that myocarditis was a side effect of the vaccine. When they read the symptoms they realized that's what he had because every symptom matched, but at the time the doctor didn't know to be looking for that.Stated that the symptoms have gradually gone away. The patient underwent lab tests and procedures which included blood test: unknown, electrocardiogram: unknown. Therapeutic measures were taken as a result of myocarditis, chest pain. The causality between BNT162B2 and Inflamed lymph nodes, high fever was related.

abrasions to my chest and left leg.; swelling; dramatically decreasedsensitivity to pain.; after receiving the vaccine Ifell; This is a spontaneous report received from a contactable consumer, the patient. A 42-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 01Apr2021 at 12:45 (at the age of 42-year-old) as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were reported as no. The patient had no known allergies. The patient did not receive any other vaccine within four weeks prior to the COVID-19 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 02Apr2021 at 08:00, the patient experienced decreased sensitivity to pain, abrasions to chest, fall and left leg swelling. The patient reported that he experienced dramatically decreased sensitivity to pain and while jogging on morning after receiving the vaccine he fell and suffered abrasions on his chest and left leg. Despite clearly visible abrasions and swelling he experienced no pain at all. 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 event fall, swelling, abrasions to chest and left leg and decreased sensitivity to pain were unknown at the time of this report. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Anaphylaxis Narrative: Pt reported trouble swallowing around 20 minutes into the observation period and was transferred to the treatment area in the vaccine clinic. Vital signs were assessed by a Registered Nurse and a Physician. Oxygen saturation was noted to be 88% on 2 liters of O2 by nasal cannula. Verbal order received at 10:03am from Physician and EpiPen administered to right thigh with improvement of symptoms. She was transferred to the Emergency Department (ED) via stretcher. In the ED, she was re-dosed with an EpiPen secondary to her airway type symptoms. She was reevaluated after 15 minutes and received Solu-Medrol, Pepcid, Benadryl IV, as well as IV fluids. She also received Ativan for her generalized jitteriness and anxiety. She improved and felt significantly better at approximately 11:43am. She was monitored for 3 hours in the ED and was discharged home at 3:34pm in good clinical condition and advised to continue to take Benadryl as needed. She carries and EpiPen on her person and was advised to return immediately if symptoms return.

Around 8pm I began having chills, body aches and SOB that lasted throughout the night. The next day I felt a little better earlier but got very fatigued, had a headache, chills and a large swollen lymph node developed under my left arm and its still there today. And my arm is sore at the injection site.

Injection site pain & swelling on first & second day. Swollen & painful left axillary lymph nodes on 3rd day.

Lymph nodes on left side are swollen. When extending arm upwards (hand above my head), I can see a bump right under my armpit. Bump is probably 3" diameter and approximately .75" in thickness (as thick as my fingers, not as thick as the palm of my hand). It's tender to the touch, but not painful. Lymph nodes on right side do not seem to be affected.

2nd vaccine on Saturday. Sunday, burning feet, leg, thigh. Went to ER to check if it was cause by diabetes, was told its probably not Gulliam Barre. Still having the symptoms. Worsen when laying down, better with movement.

12/20/2020 12/21/2020 Notices lymneos above left clavicle swollen and hard, bruising at the sight location of left arm. Several weeks and present at the second shot .

A few hours after the shot my hands and feet where tingling and felt clammy/ swollen. After work i noticed that my heart rate would increase when walking around and that the heart beat felt heavy. If i was lying down the heart rate would be slightly elevated compared to normal resting heart rate. The heart rate beat felt heavy. I went to bed early and slept through the night. I woke up the next morning and felt fatigued, dizzy, slight body ache and nauseated. no fever, no headache. i tried to take a shower but symptoms got worse. i was unable to go to work that day. I took a few naps during the day and by late afternoon most symptoms where going away. the last symptom was the issue with the hands and feet. Heart rate returned to normal. The next day i was able to return to work.

Patient reported approximately 3 hours post vaccination that they experienced itching on top of their head. Approximately 6 hours post vaccination they reported the appearance of red bumps/hives on chest, upper arms, back, and ankle along with itching in these areas. Patient reported taking a Benadryl and noticed symptoms improved within 30 -45 minutes. The following morning patient reports itching occurred again but subsided after dose of Benadryl. Patient has spoken to two separate physicians about decision to receive second doses.

chills; body aches; low grade temperature; left axilla has become very swollen and painful; left axilla has become very swollen and painful; fluid accumulation in the subcutaneous tissue; This is a spontaneous report from a contactable physician (patient). A 43-year-old male patient received his second dose of bnt162b2 (BNT162B2 reported as Pfizer COVID 19; lot number: EL3247; expiration date: unknown), via an unspecified route of administration left arm on 17Jan2021 09:30 at a single dose for covid-19 immunization. Medical history included known penicillin allergies. The patient was not diagnosed with COVID prior vaccination. The patient's concomitant medications were none. The patient previously took sulfamethoxazole-trimethoprim (BACTRIM) but had allergies. The patient historically vaccine included first dose of bnt162b2 (BNT162B2 reported as Pfizer COVID 19; lot number: EL0140; expiration date: unknown) at the age of 43-year-old via an unspecified route of administration right arm on 29Dec2020 10:00 AM at a single dose for covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and any other medications the patient received within 2 weeks of vaccination. The patient received the vaccine in a hospital but 36 hours after the vaccine (18Jan2021), the patient developed chills, body aches and low-grade temperature. Then 48 hours later, her left axilla has become very swollen and painful. The pain has subsided but remains mild and swelling persists. The area seems to show fluid accumulation in the subcutaneous tissue but no erythema or e/o [evidence of (pending confirmation)] abscess infection noted. It's now been present for 4 days. The patient received treatment which included NSAIDs. The patient had not been COVID tested post vaccination. The outcome of the events was not recovered.

anaphylaxis; This is a spontaneous report from a non-contactable healthcare professional (patient himself). A 43-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration on 28Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced anaphylaxis in Jan2021. The outcome of the event was unknown. No follow up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation and known safety profile of suspect drug. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.

Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Hypertension-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium

Chills/shivers (first day); Mild fever (first day); Lymph node inflammation in neck (on and off since the vaccine); Headache; Arm pain at injection; This is a spontaneous report from a contactable consumer (patient). A 43-year-old male patient received the first dose of BNT162B2 (lot number: EL3247), via an unspecified route of administration in left arm on 19Jan2021 13:00 at single dose for COVID-19 immunisation. The patient medical history was not reported. Concomitant medication included cannabis. The patient experienced chills/shivers (first day), mild fever (first day), lymph node inflammation in neck (on and off since the vaccine), headache, and arm pain at injection on 19Jan2021 16:00. No treatment was received for these events. Outcome of the events was unknown.

Bruising at around insertion point and a growth has appeared between my right arm pit and pectorales major.

fatigue, low grade fever and chills began ~24 hours after the second shot. ~36 hours after second shot right armpit lymph node was visibly swollen and very tender. Swelling went down over the course of 24 hours and was unnoticeable within 48 hours of appearing.

Initially had deltoid pain and swelling for 1 day, improved, then 2 days after vaccine started with swelling and pain over medial elbow. Today still has some swelling in deltoid in addition to pain/swelling in medial elbow. Symptoms also consistent with medial epicondylitis, uncertain if vaccine is contributing.

Noticed enlarged/swollen lymph node near left side collar bone, same side as injection. Noticed approximately one week after injection. Swelling is visible and can also be felt by touch. No other side effects - no pain, no fever, no headaches.

Anaphylaxis at half hour after second shot , had allergic symptoms on following Thursday 3/18 and Thurs 3/25

3/31/2021: Patient was observed post COVID-19 immunization for 30 minutes based on pre-vaccination screening. During the observation period, he experienced an adverse reaction with the following symptoms: Tingling and swelling of face and throat. Tightening sensation to the face including mouth. Sweating, with redness to the face. Mild nonproductive cough. Assessment : Time of assessment 0932am. Alert and oriented. Nurse assessed lung sounds, VS monitored for 30 minutes. Actions taken: assessment of face and mouth, no swelling seen, face is red and he has sweating forehead. Vitals sign taken at 0932 with BP- 185/131, P- 89. R-17 O2- 98% , Benadryl 12.5 mg liquid given po x 1, VS rechecked at 0937, BP - 190/134, P- 84, T- 98.4. R- 18, O2- 98%, Benadryl 12.5 liquid given PO at 0927. EMS on site due to another issue, assessed pts lung sounds and assessed for auditory stridor to neck, patient with slight cough, voices that he is feeling some better, he remains sitting in wheelchair. VS at 0947 , BP- 166/127, P- 82. O2- 98%, VS at 1002- BP_ 154/110, P- 85, O2- 96%. Medications administered: Diphenhydramine (Benadryl) 12.5 ml (25 mg) by mouth. Time: 0932 and 0937. Administered by RN. Disposition:Reports swelling to face and mouth has improved, he is advised to follow up with PCP for elevated BP AND SYMPTOMS ASSOCIATED WITH VACCINE/ Immunizations Administered Name Date Dose VIS Date Route Pfizer COVID-19 Vaccine 3/31/2021 9:08 AM 0.3 mL 12/11/2020 Intramuscular

After a few hours of getting the second shot some fever minor headaches and a stuffy nose feel with no mu us present, pain and swollen area of shot and also all my left side from head to toe started to hurt significantly to the point that a walk to the bathtroom was difficult. A few of the symptoms fade away after a few days but the left side swollen area on my leg still an issue not letting me continue my workouts, went to my doctor got a sonogram doppler no clots were found and they sent me home. Told me to rest and elevate my legs been doing that nothing has changed and a few minor headaches have made a comeback.

Next day fatigue, and brain fog. Within 24 hours noticed swollen lymph node in left armpit and tenderness (same side as shot). Swelling about the the size of a fist. 7 days later swelling remains, but reduced by 1/2 the size. Within 48 hours notices pain and swelling lymph node under right collar bone and tenderness (opposite side of shot). Swelling is minimal, but collar bone discomfort. 6 days later since onset and collar bone discomfort remains.

Face swell and eyes swell shut. Huge bumps all over body and face. I took pics. Throat was also feeling numb

I had a severe anaphylactic reaction; This is a spontaneous report from a contactable consumer, the patient. A 43-years-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration, administered in the left arm on 24Mar2021 at 10:30 as a single dose for COVID-19 immunisation. There was no medical history. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medication included ibuprofen taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 26Mar2021 at 23:15, the patient experienced a severe anaphylactic reaction, with swallowing difficult, hives, significant swelling of the face, very puffy and watery eyes, and significant swelling in the throat and uvula that made breathing and swallowing difficult. The patient went to the emergency room (ER) and received epinephrine, prednisone, and a large dose of intravenous (IV) diphenhydramine (BENADRYL). Clinical outcome of the event severe anaphylactic reaction was recovering. Information on about lot/batch number has been requested.

Office visit on 4/14/21 patient reported swelling in left lower leg that started approximately 4 days prior. Denied pain or warmth, non tender when walking or palpation. Denied recent prolonged travel, shortness of breath.

extreme fatigue; joint pain; muscle pain; nerve pain; hives; large red skin blotches on arm where vaccinated; Swelling in limbs; Headache; head pressure; This is a spontaneous report received from a contactable consumer (patient). A 43-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EW6208), in left arm on 18Mar2021 04:30 PM (at the age of 43-year-old) at single dose for COVID-19 immunization. The patient's medical history included post-traumatic stress disorder (PTSD) and seborrhea. No allergies to medications, food, or other products were reported. Prior to vaccination the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported, no other medications were received by the patient within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 18Mar2021 06:30 PM the patient experienced extreme fatigue, joint pain, muscle pain, nerve pain, hives, large red skin blotches on arm where vaccinated, swelling in limbs, headache and head pressure. The events were reported as serious since resulted in disability or permanent damage. The events resulted in doctor or other healthcare professional office/clinic visit. Treatment was received for the adverse event as steroid pills, ibuprofen, aspercreme rubs and ice pack. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was not resolved.

Fever 101-103.4 / fever chills every day for 6 days. Neck pain with swollen neck lymph nodes x 9 days, Ringing in ears interrupted sleep for 1 month, had decreased some although continues to this day. Malays for 2 weeks. Vomiting for the first 4 days.

Fever overnight following the second injection. Lymph node swelling on left side of head and neck was noticed the first morning along with a burning sensation along the scalp on the left side of head. Lumps formed under hair line on left side of head by second morning after the shot. Lymph nodes still swollen on left side of head and neck. Lumps on left side of head became tender to the touch by third morning after the shot. Sought help at "On Demand Care" on 10th day after Vaccine was given due to pain. The following issue was addressed by CNP: Herpes zoster without complication. Prescribed: acetaminophen, capsaicin and valACYclovir on April 23, 2021.

Injection site pain Extreme fatigue Muscle and joint pain Earache Fever Chills Nausea Weakness Swollen lymph nodes 24 hours of moderate symptoms followed by mild lingering symptoms

Patient reported full body rash and facial swelling after the 15 minute waiting period was complete. 5 days later, patient still has full body rash.

Typical and expected side effects were fatigue for ~24 hours and soreness at the site of injection for ~48 hours. In addition, the morning after the injection I woke up with a bright red face rash and draining on the left nostril, the left eye crusted shut with yellowish drainage, a red blister-like spot on the left lower eyelid, bloodshot eye, and swelling from the eyelid and down into the cheek. The swelling got worse after a couple of days, leading to medical treatment with eye drops and an antibiotic.

Extreme burning sensation on left arm with burning sensation travelling up to left ear Arm was later swelling and difficult to clinch fist Tight tension turning arm Arm had a small scratch from a rose thorn later and became very itchy No muscle soreness in arm

Lymph node swelling in right armpit; Also experienced flu like symptoms; This is a spontaneous report from a contactable consumer reported for himself. A 43-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm right on 28Jan2021 08:45 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included multiple sclerosis (MS) and allergy to eggs, fish and tree nuts. Concomitant medication was received (patient received other medications within 2 weeks). The patient experienced lymph node swelling in right armpit. It was about the size of a half-dollar four days after vaccination. Also experienced flu like symptoms. The events onset on 30Jan2021 at 7:00. No treatment was received. Outcome of the events was not resolved. This case was reported as non-serious. 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.

Shingles. I received the second dose of covid vaccine on Wed, April 28. Three days later, Saturday May 1, I woke up with intense abdominal pain, spanning the entirety of my stomach, and wrapping around my right oblique and kidney area. I had thrown out my back one week prior, assumed this was more muscle pain, and treated it as such. The Monday following, May 3, I went to the chiropractor, still in intense pain, but also with a tingling sensation on the affected area, sensitivity to the touch without pain. I assumed that I had burned myself with the heating pad. Wednesday a rash began to form in the affected area. My pain was nearly gone, I no longer felt muscle tightness, and assumed that the condition was resolving itself, and that the rash was heat rash from the heating pad. Friday the rash was redder and my abdomen showed signs of significant swelling. I still thought this was muscular, that perhaps I had pulled the abdomen, treated with ice and decided to visit Orthopedic urgent care Saturday. Saturday the pain had increased. I went to Urgent care, and was told I have shingles. I asked if the covid vaccine could have caused shingles to flare, was told "theoretically", but thar we do not really know enough to say whether the vaccine contributed, or whether it was coincidence. At home, I read a bit on the covid vaccine qnd shingles, saw what appeared to be anti-vaccer propaganda, but also read about this self-reporting system...so, I thought that I might as well submit my info.

The events have been injection site pain, arm soreness, headaches, dizziness, nausea, diarrheas, swelling, and vomits.

PATIENT RECEIVED PFIZER COVID-19 VACCINE ON 05/20/2021 AND THREE DAYS LATER ON 05/23/2021 PT STARTED NOTICING SWOLLEN LYMPH NODES ALONG THE COLLOR BONE AREA. HE CONTINUED TO MONITOR FOR SEVERAL DAYS AND FOLLOWED UP WITH PT ON 06/02/2021 WHO STATED THAT THE SWELLING WAS STILL APPARENT AND HE MADE AN APPOINTMENT TO SEE THE DOCTOR TO FOLLOW UP WITH THIS ADVERSE EVENT.

Developed right neck swelling/adenopathy which spread to the left. Significant to impair neck mobility. Developed high fevers roughly 12 hours later with rigors. Was seen in the emergency department. Found to be febrile, significantly tachycardic (sinus) . Was given vancomycin, ceftriaxone empirically. Felt ill for the next 48 hours afterwards with weakness, slow to resolve tachycardia and cough. Neck swelling subsided however, right neck lymphadenopathy persisted for well over a month. Was sent home from ED with Bactrim and keflex for coverage of possible neck cellulitis. However, I do not believe it was a cellulitis. Neck was not tender, not indurated nor erythematous. I am a hospitalist and had colleagues take a look as well.

Left foot became swollen the day after first dose then continued to swell with numbness in both feet then by the 5th day my right foot became extremely swollen and i went to medical center. A rash formed I also on my ankle area . I took pictures if needed. Spent 2 night in observation at hospital. Still have numbness and raised skin on my right toe.

A few days after the second shot lymph nodes under arm very very swollen under left arm as large as an apple now several months later lymph nodes are still swollen and resting heart rate is quite high and wife has cystic acne also months after and NEVER had acne previously.

Patient reported he received a dose of the Pfizer COVID vaccine 1 day before onset of increasing firm nontender swelling of the left costochondral junction at the level of the 2nd rib. On exam, this area was nontender and palpated similar to a skeletal prominence but patient endorsed that this was entirely new to him. He felt discomfort deep to the swelling, but this was not worsened by touching the area.

UPPER RESPATORY, SORE THROAT, SWELLING IN THE BACK OF NECK, THRASH ANTIBIOTICS STEROIDS (PREDNAZONR), AUGMENTEN

shortness of breath and chest pain have subsided; Dizziness; swelling underneath my armpit; not feeling well; nausea; This is a spontaneous report from a contactable consumer. This 43-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration on 06Feb2021 (age at the time of vaccination was 43 years) as a single dose for COVID-19 immunization. The patient's medical history included shortness of breath and chest pain. The patient's concomitant medications were not reported. On 06Feb2021, the patient experienced dizziness and it was getting better. On an unspecified date in Feb2021, the patient experienced nausea and was not feeling well. The nausea was getting better. Last night (on the day of reporting), the patient had a little bit of swelling underneath his armpit. The swelling under the arm had improved previous day night. On an unknown date, the patient underwent COVID test and shown negative results. The shortness of breath and chest pain had subsided after the patient got vaccinated. The outcome of the events was recovering. Information about lot/batch number has been requested. Follow-up (11May2021): Follow-up attempts completed. No further information expected.

Fatigued; Lymph nodes swollen under arm pit; This is a spontaneous report received from a contactable other health care professional. A 43-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 01Feb2021 as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 (Lot: unknown) on 11Jan2020 in the Left arm for COVID-19 immunisation. Patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, was the patient did not diagnosed with COVID-19. Since the vaccination, did not patient been tested for COVID-19. The patient experienced extremely fatigued and lymph nodes swollen under arm pit. No treatment was received for the events. The outcome of the events was reported as recovering. Information about lot/batch number has been requested. Follow-up (14May2021): Follow-up attempts completed. No further information expected.

Almost about 1 week after getting second shot of covid-19 vaccine I started feeling weird on right side of my body. Swollen right side of my body specially facial area, which got worse over the period of time. Now main symptoms i am having are tender facial muscles , hoarseness, loss of voice and blurry vision on right side. Symptoms got worse last week.

swollen right armpit; redness around injection site which the skin was hot to the touch; headache; body aches; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199), via an unspecified route of administration in the right arm on 25Mar2021 at 13:30 (at the age of 43-years-old), as a single dose for COVID-19 immunisation. The patient had no medical history. The patient did not have any allergies to medications, food, or other products. Concomitant medication was not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN5318), via an unspecified route of administration in the right arm on 04Mar2021 at 11:30 (at the age of 43-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 4 weeks prior to the COVID vaccine. On 26Mar2021 at 18:00, after the second dose, the patient experienced headache and body aches which started by the evening. On 27Mar2021, the patient experienced swollen right armpit and redness around injection site which the skin was hot to the touch. The patient continued to feel body aches. The patient did not receive any treatment for the adverse events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events headache, body aches, swollen right armpit and redness around injection site were resolved on 28Mar2021. No follow-up attempts are needed. No further information is expected.

Large lump under right armpit; Water retention on torso, down to stomach on right/SHOT SIDE ONLY; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in the right arm on 25Mar2021 at 12:15 (at the age of 43-years-old) as a single dose for Covid-19 immunisation. Medical history was reported as none. The patient had no allergies to medications, food, or other products (as far as patient was aware of). The patient did not receive any concomitant medications within 2 weeks of the vaccine. Prior to 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 COVID vaccine. On 27Mar2021, the patient experienced large lump under right armpit and significant water retention on torso, down to stomach on right and never experienced this before. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not received treatment for the reported events. The clinical outcome of axillary lump and water retention was not recovered at the time of report. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Swollen lymph nodes; This is a spontaneous report from a non-contactable consumer, the patient. A 43-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 31Mar2021 at 10:45 (at the age of 43-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not received any other medications with in 2 weeks of COVID-19 vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration in the left arm on 10Mar2021 at 11:30 as single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks, prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not tested for COVID-19. The patient experienced swollen lymph nodes on 01Apr2021 at 17:00 . The patient did not receive any treatment for the reported event. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event swollen lymph nodes was recovering. No follow-up attempts are needed. No further information is expected.

Site: Pain at Injection Site-Severe, Systemic: fluid pocket under right arm pit-Medium, Systemic: Lymph Node Swelling-Medium

On Saturday and Sunday I had extreme fatigue with a low fever. I had a swollen arm and some minor joint pains. Since then I have suffer from fatigueness everyday with some shoulder pains.

Dizzy, rapid heart beat, nausea, ended of having a ?zombie like episode? according to my 10 year old daughter who was with me. Apparently I fainted but she described me as twitching and having my hands up and my head to the side with my eyes closed. I can remember a repetitive loop that I was experiencing. It was an image that was distorted and I could not control it and I could not get out of it I could hear my daughter but not control my actions. After I came to a few moments later my legs felt tingly and tired and were shaking like they had the chills. Was advised to go to hospital by EMS Still having very achy joints all over my body. Diarrhea, sweats/chills

He began to have lower extremity weakness on Sunday 7/18/21. He went to an outside hospital ER on Sunday due to LE weakness and diagnosed with a heat stroke and discharged home. On 7/20/21, he came to ED and reported the weakness had moved up into his upper extremities. Admitted to the hospital on 7/20/21. He has been unable to stand or use his upper extremities for the past 3 days. On exam he has tremor of the jaw, he reports he does not notice this. He does have sensation intact. Intubated and placed on ventilator on 7/20/21 for respiratory distress. Diagnosed with Guillan-Barre syndrome requiring a trialysis catheter placement acutely for plasmapheresis. Plan plasma exchange 6 times, with treatment every other day. As of today, 7/28/21 patient remains hospitalized.

Left under arm (lymph node) very sore; This is a spontaneous report from a contactable consumer, the patient. A 43-years-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 left arm on 26Apr2021 at 12:00 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included fluvoxamine maleate (LUVOX), lamotrigine (MANUFACTURER UNKNOWN), simvastatin (MANUFACTURER UNKNOWN), lisinopril (MANUFACTURER UNKNOWN) and proto from an unknown date for an unknown indication. The patient previously 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 05Apr2021 at 12:00 (at the age of 43-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 4 weeks prior to the COVID vaccine. On 28Apr2021, the patient experienced left underarm (lymph node) very sore. The clinical outcome of the event left underarm (lymph node) very sore was not recovered at the time of the report. No follow-up attempts are needed; information about the lot number cannot be obtained.

Lymph node in left armpit tender; Swollen Lymph node in left armpit; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration in the left arm on 03Apr2021 at 13:30 (at the age of 43-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history. Patient had no allergies to medications, food, or other products. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) from an unknown date for an unknown indication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202) via an unspecified route of administration in the left arm on 06Mar2021 at 13:30 (at the age of 42-year-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. On 03Apr2021 at 21:30, the patient experienced swollen lymph node in left armpit, which was also tender for a limited time. The events 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 reported events. The clinical outcome of the events of lymph node tenderness and axillary lymph nodes enlarged were recovering at the time of this report. No follow-up attempts are needed. No further information is expected.

swollen lymph node on left jaw; itchy skin; This is a spontaneous report from a contactable other healthcare professional, the patient. A 43-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Er8737) via an unspecified route of administration in the arm left on 02Apr2021 at 16:00 (at the age of 43-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history. Concomitant medications included finasteride (MANUFACTURER UNKNOWN) and minoxidil (MANUFACTURER UNKNOWN) from an unknown date for an unknown indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: En6199) via an unspecified route of administration in the arm left on 12Mar2021 at 16:00 (at the age of 43-year-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 23Apr2021 at 16:00 the patient experienced swollen lymph node on left jaw and itchy skin. The events resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the events swollen lymph node on left jaw and itchy skin was not recovered. No follow-up attempts are needed. No further information is expected.

Client noticed this afternoon when showering that his left armpit region was swollen approximately the size of a tennis ball and tender. Client declines any fever, redness, not warm to the touch either. Client states that he thinks it feels like enlarged lymph node

Swelling noticed in left axilla approximately 18 hrs post injection. Swelling increased to the size of a softball and persisted from 1/8 noon through 1/10 at about 8 pm when I started to notice a decrease. Ice was applied every 2 hours (while awake) for 2 days and ibuprofen was taken 800mg every 6 hours from 1/8am to present (1/12 pm).

right arm became red and swollen and painful. Right arm redness/rash spread to triceps. Denies treatment. Patient states that it resolved on 01/14/21.

right armpit and right collar bone ball half the size of an egg. if you push you can feel 4 marble sized bumps. Pfizer on 1st dose December 30th, second dose January 20th.

s/p vaccination with 2nd Covid Vaccine dose, developed low grade viral type illness with fevers up to 102 with myalgias, fatigue. Began to recover, teh awoke in the morning of 1/16/20 wtih crushing, substernal chest pain. Presented to the emergency department. Was admitted to he hospital - diagnosed with myopericarditis. Stayed in the hospital one night, and discharged the next day.

Pt reports that from day 7-10 (post vaccine) he had a 'cytokine like response" with redness, swelling and pain extending from left shoulder to under arm and chest area. Did not see PCP. Took OTC analgesic, resoled on day 10 post vaccine the response dissipated.

Fever/a temp of 101; feels something is different; intermittent minimal pain especially when he wakes up; Tachycardia; His CRP was up a little at 1.1; Nausea; Shortness of breath; Fatigue; Pain at injection site left shoulder; This is a spontaneous report from a contactable physician reporting for himself. A 44-year-old male patient received the first dose of bnt162b2 (BNT162B2, lot number and expiry date were not reported), via an unspecified route of administration, on 28Dec2020, at a single dose on the left shoulder (arm left) for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient received the first dose of the vaccine on 28Dec2020. Since receiving the vaccine, he has experienced multiple side effects at varying time points: pain at injection site left shoulder (experienced pain first day of receiving vaccine on 28Dec2020 and couple of days after fever (unspecified date) resolved (on an unspecified date); he was currently experiencing intermittent minimal pain especially when he wakes up; feels something is different; fever (experienced 08Jan2021); fatigue (developed 07Jan2021). He went to the ER on 08Jan2021 when he developed fever, nausea and shortness of breath which also resolved that day. When he went to ER, his CRP was up a little at 1.1. His PCR and antigen test was negative at that time (08Jan2021); a retest of PCR done 5 days after sxs started (unclear of time window) was negative. He was concerned that he had the fever many days after the vaccine. HCP was asking if any cases of fever and fatigue reported after 7 days (around the 10 day mark) of receiving the first dose. He stated that he is planning on taking the second dose. The patient is a physician calling about the Pfizer covid vaccine. He received his first dose on 28Dec2020. He had a little bit of pain in his left arm on same day, but it went away. About 10 days later, 07Jan2021, he had fever and fatigue. On 08Jan2021, he went to the ER with a temp of 101. He had tachycardia, nausea and shortness of breath. He was not admitted, stated his fever was controlled and his breathing was better. His oxygen was 100% and everything was ok and he was sent home. In the ER he had xrays and labs and everything was ok, except his CRP was a bit up. In the ER he had an antigen and pcr covid test (08Jan2021) and they both came back negative. About 4 or 5 days after the symptoms started, he had an outpatient repeat pcr test and nucleic acid rapid test (unspecified dates) and they both came back negative. He is on his way to get his second dose and he is asking if the symptoms could be side effects from the vaccine. Outcome the event fever was recovered on an unspecified date. Outcome of nausea and shortness of breath was recovered on 08Jan2021, while outcome of pain at injection site left shoulder was recovered on 28Dec2020. Outcome of the remaining events was unknown. Information about lot/batch number has been requested.

Fever, chills, body aches, lethargy; strong onset approximately 11 hours after injection. Minor pain/redness at injection. Symptoms lasted 3 days, gradually improving after first day. Highest recorded fever ~101F via forehead scanner, but suspect higher the first night (did not record it) based on very strong chills and shivering. Multiple Fever Blisters/Cold sores after 2 days, treated with Abreva. Note there were no symptoms/side effects after first dose (Lot# EL3302, administered 01/08/2021).

Swelling under right armpit near the pectoralis. Soft and tender to the touch. About the size of a chicken egg cut in half lengthwise.

Started at 3:30 pm on 2/26/21 with neck tightness and eye pressure. Approximately around 6:30 pm, experienced lip burning/numbness/swelling and facial swelling and drooping. Went to ER and given IV Benadryl and IV Pepcid. Discharged a few hours later. All symptoms have since resolved.

sore arm; restlessness; Body aches; chills; fatigue; Swollen lymph node under left clavicle; This is a spontaneous report from a contactable consumer (reported for himself). A 44-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot no: 9262), on Left Arm via an unspecified route of administration on 26Jan2021 13:30 at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient previously took first dose of PFIZER-BIONTECH COVID-19 VACCINE (Lot no: 3248) on left arm on 07Jan2021 12:00 PM for Covid-19 immunization. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 26Jan2021 10:00 PM No symptoms besides a sore arm and restlessness for first 12 hours. Body aches, chills, fatigue for following 24 hours. Fatigue for an additional 24 hours. Swollen lymph node under left clavicle starting at 36 hours and still present. Outcome of the events was not recovered.

first covid 19 vaccine received around 2:20 PM on 03/10/2021. He reports minimal edema Rt Axilla around 6AM on 03/11/2021.Increase in size and pain by 1 PM on 03/12/2021 with evaluation per work- Occupational Health Nurse.2-3 cm swollen medial lymph node evaluation. Definitive tenderness @ the site. Tylenol for pain used.

NECK PAIN, GRADUALLY WORSENING OVER 2-3 WEEKS, FEELS LYMPH NODES ARE SWOLLEN IN HIS SUBMANDIBULAR REIGON, ANTERIOR CERVICAL CHAINS, SUPRACLAVICULAR REGIONS.

Burning sensation in injection side shoulder, Swollen/painful lymph node along collar bone 6 days following vaccine

pain in the right TMJ joint But has a sharp pain toward the right forehead, cheek and chin Not a numbness Just a pain Improves when not chewing and opening jaw, feels fine. No fevers or chills Denies any tooth/gum pains. This occurred after taking the covid pfizer shot, 2nd does, didn't really notice Didn't really notice his face was swollen until today. No heat/itch.

Patient came to get his 2nd dose vaccine today 4/21/21 and upon asking him if how his first dose went, he mentioned that he had ringing in his right ear and swollen lymph nodes around his right neck area about 3 days after getting the vaccine. The swollen lymph nodes lasted for a full week and then it went away. He still has ringing in his right ear but is very faint as compared to when he first noticed it.

Patient presents to the ED with chief complaint of swollen lymph nodes in the area of the left clavicle with pain radiating down his left arm.

chill; half face was swelling; fever (99-100F); much stronger pain with the tooth; much stronger pain with the tooth; This is a spontaneous report from a contactable consumer reported for himself. A 44-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in left arm on 24Mar2021 15:45 (Batch/Lot Number: ER8727) as single dose for covid-19 immunisation. Medical history included one tooth with some inflammation and pain. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. None allergies to medications, food, or other products. The patient's concomitant medications were none. The patient experienced much stronger pain with the tooth on 24Mar2021 18:15 with outcome of recovered, half face was swelling on 25Mar2021 (next morning)with outcome of recovered, fever (99-100f) on 25Mar2021 (next morning)with outcome of unknown, chill on unspecified date with outcome of recovered. The chill, swelling and pain last 3-4 days post injection. Therapeutic measures (Advil) were taken as a result of much stronger pain with the tooth. Follow-up attempts have been completed and no further information is expected.

Left side supraclavicular lymphadenopathy. Lymph node swollen, soft and painful, measuring about 1 in wide and 0.7 in high. Sore left arm after administration of the vaccine which resolved without any treatment on the second day after administration.

Swollen lymph node in left armpit/same side as injection. Additional symptoms include fatigue, joint pain, overall aching.

A couple minutes after patient got the first dose of Pfizer vaccine, patient complaint not feeling well, sweating, tongue feeling funny and not able to see. My technicians laid him down on the floor and contacted 911 to send medics. Patient was still alert but later complaint difficulty breathing. Pharmacist notice swelling around pt's neck area and weak pulses. Pharmacist administered an epipen and stayed with patient. A few minutes later, patient symptoms subsided , medics arrived and brought him to the hospital.

Patient is a 44 y/o gentleman with acute renal failure, elevated BNP and LE edema. Pulmonary consulted for medical management. Thrombocytopenia: - plt count stable today, Hgb stable - hematology consulted, appreciate recs: plan to send for serum antibodies to test for drug induced thrombocytopenia for carbamazepine and valproic acid - will hold protonix as possible offender - peripheral smear (Mercy OKC, 5/8/21): macrocytic red blood cells, moderate thrombocytopenia, rare focal platelet clumping present - less likely vaccine induced TCP---usually this is seen with the AstraZenca and Johnson and Johnson vaccine, not in Pfizer vaccine - if plt remains stable, may d/c home with plan for f/u with Dr outpt COVID-19: - case discussed with Health Department, COVID test for variant testing sent 5/6 - for now, will cont care in isolation - patient with positive COVID-19 test - positve COVID-19 test in January 2021, negative COVID-19 screen in April 2021 - pt with no active respiratory sx AMS: unchanged - waxing and waning mental status - improved AMS with improved renal fxn Acute renal failure: improving - Cr: 1.64, cont PO intake LE edema: - unchanged, low albumin levels, need to increase protein intake Chronic systolic heart failure: stable - cont to hold diuresis Disposition: - cont care in COVID unit, Pulmonary to follow Estimated length of stay is 5 day(s).

Right auxiliary edema extending to right pectoral muscle and lymph node swelling; Right auxiliary edema extending to right pectoral muscle and lymph node swelling; This is a spontaneous report from a contactable Pharmacist (patient) A 44-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in Arm Right on 10Feb2021 15:30 (Batch/Lot number was not reported) as second SINGLE DOSE for covid-19 immunisation.Age at vaccination :44 years. The patient received the first dose at age of 44 years on 23Jan2021 at 4:00 p.m . No other vaccine in four weeks .The patient medical history was not reported. Concomitant medication(s) included fish oil (FISH OIL) taken for an unspecified indication, start and stop date were not reported. The patient experienced right auxiliary edema extending to right pectoral muscle and lymph node swelling on 12Feb2021 with outcome of not recovered.No treatment received. No COVID prior vaccination.No COVID tested post vaccination. No follow up attempts are possible, information about lot/batch number cannot be obtained.

I had a 102.5 degree fever off and on for two days; severe body aches; chills; headaches; injection site soreness; redness; skin sensitivity; brain fog; hot flashes; fatigue; swollen lymph nodes (left armpit); This is a spontaneous report from a contactable other hcp. A 44-year-old male patient reported for himself that he received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9268), via an unspecified route of administration, administered in Arm Left on 12Feb2021 14:00 (at the age of 44-year-old) as 2nd dose, single for COVID-19 immunization. Medical history included migraines. Patient had no known allergies. Patient had not covid prior and post vaccination. Concomitant medication(s) included ibuprofen (ADVIL LIQUI GELS); acetaminophen (ACETAMINOPHEN). Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL3247), via an unspecified route of administration, administered in Arm Left on 26Jan2021 02:45 (at the age of 44-year-old) as 1st dose, single for COVID-19 immunization. The patient stated that on 13Feb2021 02:00, he had a 102.5 degree fever off and on for two days, severe body aches, chills, headaches, injection site soreness, redness, skin sensitivity, brain fog, hot flashes, fatigue, and swollen lymph nodes (left armpit). Patient did not received any treatment for the events. The outcome of the events was reported as recovering. Follow-up attempts have been completed and no further information is expected.

Full body rash with swelling and hives and pain in his foot hands torso legs. He was given 100 mg of Benadryl by mouth and partial Medrol pack by family. Then later that day he went to the emergency room and was only treated with Decadron 10 mg and Benadryl 50 mg. He was discharged with a Medrol dose pack. Continues to have hives and pain all over his body.

possible hallucinations; severe chills; severe back spasm; nausea; dizziness; the lymph node under my right arm (the arm that was injected) was swollen to the size of a softball.; This is a spontaneous report from contactable consumer (patient). A 44-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EP7533) via an unspecified route of administration, administered on the right arm on 30Apr2021 09:15 (Batch/Lot Number: EP7533) as unknown, single for COVID-19 immunization. The patient had no medical history. Concomitant medication included ascorbic acid, betacarotene, biotin, boron, calcium, calcium pantothenate, chloride, chromium, colecalciferol, copper, cyanocobalamin, folic acid, iodine, iron, lycopene, magnesium, manganese, molybdenum, nickel, nicotinamide, phosphorus, potassium, pyridoxine hydrochloride, retinol, riboflavin, selenium, silicon dioxide, thiamine, tin, tocopheryl acetate, vanadium, vitamin k nos, zinc (CENTRUM MEN). The patient had severe chills, severe back spasm, nausea, dizziness, possible hallucinations, and the lymph node under my right arm (the arm that was injected) was swollen to the size of a softball on 30Apr2021 07:00 PM. No treatment was received for the events. 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. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has not been tested for COVID-19. Prior to vaccination, the patient was not diagnosed with COVID-19. No known allergies. Outcome of the events was recovering.

3/12/21 persistent pain in the right shoulder since receiving his vaccine in December. History and physical exam are most consistent with post vaccination subacromial bursitis. Given lack of response to conservative therapy, I recommended subacromial bursa injection today. Patient experienced immediate relief following procedure.

1st shot 4/13, no issue with injection site. About a week later had trouble breathing, chest pain, felt like lungs were hurting in my back, weak, tired, couldn't catch my breath when i went upstairs and almost passed out. 2nd shot 5/04, felt pain at injection site (that was expected), that night started to get a bad headache and got worse and worse. Next morning, whole body aching, upper body, lower back, bad headache, Left underarm (lymph) swollen. 2nd day slight headache, neck ache, left underarm swollen. That night had rash on arms, chest, and stomach. 3rd day, nighttime rash arms, chest, stomach. Still red where band aid was over injection site. Over a week later still have redness shape of band aid, Seems I have sensitive skin since the 2nd covid shot. 10 days after 2nd shot I still have redness the shape of the Band Aid on my left arm. Got a red spot on my nose (looks like Rosacea). 4 weeks later, still have a red spot on my nose. I have itchiness between fingers left hand, on my face left side, neck, arms (left wrist, right arm in places) redness on chest, and rashes on back, left buttocks, and itchiness on legs. i noticed that it gets worse at night. As far as i know i did not get the Covid Virus, i did the rapid test and regular test and both were negative. But i was very sick with my stomach and had issues breathing in late 2019 and again early 2020, took medication (antibiotics) both times. I had to write on this form over and over again kept getting frozen with error from the PDF. Even if I hit OK, it keeps popping up and does not let me finish, so I can imagine that lots of people gave up, like I may. Pfizer 4/13/2021 EW0162. After 5pm Pfizer 5/04/2021 EW0170. After 2pm

rash on arms; little restless; noticed how sore his arm was/pain in his arm; trouble sleeping/problems with sleep; felt movements in his chest at times; felt like he had COVID all over again/ if he possibly has COVID-19 again; soreness; heart rate accelerated; some swollen in lymph nodes; This is a spontaneous report from a contactable pharmacist (patient) via a Pfizer sponsored program. A 44-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 22Mar2021 at around 13:00 or 13:30 (at the age of 44 years old) (Lot Number: EP7534, unknown expiration) as 1st dose, single for COVID-19 immunisation. Medical history included COVID-19 in Nov2020; sneezing and runny nose both on 21Mar2021. The patient's concomitant medications were not reported. The patient reported that he received his first dose of Pfizer COVID vaccine on 22Mar2021. He felt fine after receiving the vaccine, but there was little bit rash on arms just afterwards and felt maybe a little restless but felt fine and went for a walk on 22Mar2021. As the night went on, he really noticed how sore his arm was/pain in his arm and when he was sleeping, he had trouble sleeping/problems with sleep (Mar2021) and felt movements in his chest at times (Mar2021). It felt like he had COVID all over again and had chills, soreness, and his smell was kind of gone in Mar2021. He was previously feeling pretty good. He had COVID-19 in Nov2020, and his symptoms feel very similar including loss of sense of smell but no coughing. He had a fever but that has gone away in Mar2021 and he did not take aspirin or anything for it. He also had fatigue, some swollen in lymph nodes, and his heart rate accelerated in Mar2021. He had sneezing and runny nose the day prior to receiving the vaccine. The patient would like to know if his symptoms are related to the vaccine or if he possibly has COVID-19 again. His symptoms are the same as COVID as far as what he can see, and his symptoms are really high. He would like to know if he can still receive the second dose of the vaccine if he has a positive COVID test after the first dose of the vaccine. The patient mentioned that there was very pretty high percentage of people having the symptoms after having the vaccine, kind of virus "causing". The patient asked if he needs to be tested to see if he had the virus before he was vaccinated and to know if these are one of the side effects or one of the symptoms of the virus, and to make sure that these are not actually corona virus. The patient recovered from fever in Mar2021, while unknown outcome for the remaining events. No follow-up attempts are possible. No further information is expected.

Patient who had been infected with COVID19 in December 2020 and received bamlanivimab therapy. After recovery he received his COVID-19 vaccine series 4/1/2021 & 4/22/2021 with Pfizer-BioNTech. Patient then developed headache, chills, fever, body aches, thrombocytopenia, and elevated troponin levels on 5/10 and was admitted to the hospital 5/14. Concern for COVID-19 vaccine induced MIS-A or myocarditis. Patient received IVIG after ruling out other diagnosis and had a good recovery resulting in discharge home.

Tingling hands and feet started same day. Continues off and on for 6 weeks now. Chest pain upon even mild exertion like walking around the block. Lasted for a few weeks. Right arm bone pain severe lasted for about 3 weeks Spine felt swollen near coccyx/sacrum and C7-C6 pain. Feeling of Lower spine swelling and pain started less than 24 hrs. after. Lasted approx 2 weeks. Extreme tiredness lasted 2 weeks Baseball shaped raised area on chest near right arm(vaccinated arm) started perhaps a week in and lasted about a week.

Client came to vaccination site at 1715 for his 2nd Pfizer dose on 06/13/21. After being seated with RN, he expressed concern about receiving his 2nd dose due to the reactions he experienced after receiving his 1st dose. RN requested Lead RN speak with the client regarding his concerns. At 1720 Lead RN spoke to client. Client stated that 1 ½ days after getting his 1st dose, he experienced soreness & tenderness in the axillary area of the left arm. Client stated that 3 days later his axillary area began swelling. The swelling continued below his axillary down the left side of his abdomen and onto the left side of his back. Client stated the pain level was a 4 on a scale of 0-10. He also stated there was no discoloration or redness in any of the areas where he experienced swelling. On day 10 the left side of the client?s neck began to swell. He also started to experience discomfort at the injection site and arm fatigue. Client stated at no time did he experience any trouble breathing, shortness of breath, or chest pain. Client stated he has been dieting and lost 145 lbs. in the last year. He previously had high blood pressure, but no longer does. He also stated the only other underlying conditions he has is a thyroid problem (hypothyroidism), and he is not medication compliant. Over the last 6 months he has only taken his levothyroxine intermittently. In the last 2 months he has not taken any of his levothyroxine until a few days ago. Client takes no other medication, but is allergic to penicillin-based antibiotics. Client stated he gets dizzy, hallucinates, and swells up in various places on his body. However, he does not experience shortness of breath or trouble breathing. Client did not take any medication for the side effects he experienced after receiving his first Pfizer injection or seek medical treatment. Client stated all the swelling began to subside on day 17. Lead RN performed a medical consult with Clinical Care Coordinator who authorized moving forward with administering client a Pfizer 2nd dose in the opposite arm with a 30-minute observation. Prior to RN administering vaccine, Lead RN educated client on normal vs adverse effects of the vaccine. Lead RN confirmed with client that he has access to a HCP for follow-up, if needed. Lead RN also recommended client follow-up with his HCP regarding his hyperthyroid condition. Lead RN instructed client to seek emergency care if he experienced shortness of breath, trouble breathing, or chest pain at any time after leaving the vaccination facility.

Throat/tongue and neck area swelling for about an hour. Anxiety and some dizziness. Problem began about half hour after injection then went away after an hour or so after it began - but my doctor recommended that I do not to get second shot because of this reaction.

Waxing/waning constellation of symptoms that include shortness of breath, chest pain, tachycardia, and fever along with recurrent eosinophilic pleural effusions.

Small, hard mass started 2 days after the 2nd vaccine shot in left breast and turned into a mass the size of a golf ball after 3-4 weeks, that is painful and has not gone down in size.

NOTICE PAIN UNDER ARM PIT. LYMPH NODES; PAIN LIFTING ARM.; NOTICE PAIN UNDER ARM PIT. LYMPH NODES; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN6208) via an unspecified route of administration in left arm on 17Mar2021at 13:15 (at an age of 44-year-old) as a single dose for Covid-19 immunisation. Medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. On 05Mar2021 the patient underwent COVID-19 nasal swab test and the test result was found to be negative. On 19Mar2021 at 17:00, the patient experienced events of pain lifting arm, pain under armpit and lymph nodes pain. The patient did not receive any treatment for the reported events. Events didn't result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events pain lifting arm and pain under armpit were not recovered. No follow-up attempts are possible. No further information is expected

Significant stiffness in finger joints, wrists, both hands. Intermittent swelling of finger joints , especially thumb. Stiffness worse in morning and night. Being treated via physical therapy. On going from 4/2/2021 to present.

Tiredness; swollen lymph node by jaw; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: unknown) via an unspecified route of administration 24Mar2021 at 02:15 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were reported as no. There were no known 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 COVID-19 vaccine. On 24Mar2021 at 19:00, the patient experienced tiredness and swollen lymph node by jaw. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient did not receive treatment for the reported events. The clinical outcome of the events tiredness and swollen lymph node by jaw was recovering at the time of this report. Information about lot/batch number cannot be obtained. No further information is expected.

This is a spontaneous report from a contactable consumer (patient). A 44-year-old male patient received bnt162b2, via an unspecified route of administration, administered in Arm Right on 21Apr2021 (Lot Number: EN6204) as DOSE 1, SINGLE at the age of 44 years old for COVID-19 immunization. Medical history included iodine dye sea salt allergy from an unknown date. Concomitant medications included testosterone taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The facility where the most recent COVID-19 vaccine was administered was in the doctor's office/urgent care. The patient has not been COVID-19 tested since the vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. On 21Apr2021, the patient experienced having blood pressure stayed about 161/110 for 4 days until given steroid shot. Sea salt allergy went from mild to anaphylaxis in 2021. Trip to ER on 29May2021. Two trips to ER in June with abnormal heart beat and breathing issues in 2021. Now having diabetes issues in 2021. Doctors are puzzled that it all started with first Pfizer shot. No blood pressure issue at that time. Blood pressure randomly goes high and pulse will drop as low as 36 bpm in 2021. The events resulted in doctor or other healthcare professional office/clinic visit; and emergency room/department or urgent care. The outcome of the events was not recovered. No treatment given to the patient for the events.

Blood pressure randomly goes high and pulse will drop as low as 36 bpm; Blood pressure randomly goes high and pulse will drop as low as 36 bpm; Now having diabetes issue; Two trips to ER in June with abnormal heart beat and breathing issues; Two trips to ER in June with abnormal heart beat and breathing issues; Having reactions to anything with sodium over 50mg.; Sea salt allergy went from mild to anaphylaxis; This is a spontaneous report from a contactable consumer (patient). A 44-years-old male patient received second dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 12May2021(age at vaccination:44 Years) as single dose for covid-19 immunization. Patient didn't received other vaccination within 4 weeks prior to vaccination. Medical history included iodine allergy from an unknown date and unknown if ongoing, food allergy sea salt allergy from an unknown date and unknown if ongoing. Concomitant medications included testosterone (TESTOSTERONE) taken for an unspecified indication, start and stop date were not reported; diphenhydramine hydrochloride (BENADRYL) taken for an unspecified indication, start and stop date were not reported. Patient was not diagnosed with COVID-19 prior to vaccination and was not tested to COVID-19 to post vaccination. Patient previously received first dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number EN6204) via an unspecified route of administration in Arm Right on 21APR2021 as single dose for covid-19 immunisation. It was reported that blood pressure stayed about 161/110 for 4 days until given steroid shot. Sea salt allergy went from mild to anaphylaxis. Trip to ER on 29May from Turkey with sea salt. Since then having reactions to anything with sodium over 50mg. Went on low sodium diet. Two trips to ER in June with abnormal heart beat and breathing issues. Now having diabetes issues. Doctors are puzzled that it all started with first Pfizer shot. Was given Benadryl shot with second Pfizer shot on 12May2021. No blood pressure issue at that time. Blood pressure randomly goes high and pulse will drop as low as 36 bpm. Patient went for Emergency room and physician office visits for the events. The outcome of the events anaphylactic reaction, diabetes mellitus, heart rate irregular, dyspnoea, hypertension, heart rate decreased, reaction to food additive was not recovered. Information on the lot/batch number has been requested.

12/23/2020 sharp pain left lower breast, chest constriction lasted approx for 2 days on and off. 12/26/2020 swollen left armpit, resolved 01/04/2020. Antibiotic prescription provided.

Rash Rash on face and facial swelling Narrative: Developed a rash the day of the vaccine and then woke up with eye and facial swelling the following day. States he took Benadryl which helped the rash go away, but some of the swelling remains today. States it was difficult to open his eye lids first thing in the morning.

Approximately 2 days after 2nd injection I started developing itchy hands with associated swelling as well. 4 days after injection I developed a rash to feet, legs, groin and parts of torso with associated swelling. No shortness of breath but do have some slight burning to hands and legs with mild pain.

Swollen and painful lymph nodes in left armpit. Swelling lasted 2 days. Pain lasted 3 days. Symptoms were treated with Tylenol, Advil, and propping left arm up with a pillow to prevent pressure on under arm area.

Appendicitis, presenting as periumbilical tenderness at onset (26 hrs after vaccine admin) migrating to RLQ approx 20hrs later (46hrs after vaccine admin) accompanied by fever, chills, sweats, and nausea. Presented to ER that evening and CT confirmed appendicitis (52hrs after vaccine admin). Surgery following day laparoscopic appendectomy (69hrs after vaccine admin). Recovery and clinical improvement over next 8hrs (77hrs after vaccine admin). Discharged following day (96hrs after vaccine admin)

Fever, chills with temperature range between 101.8 - 102.5 F while on acetaminophen to max 24 hour dose; unilateral left axillary and subpectoral adenopathy - easily palpable nodal conglomerate; fever resolved the next day; adenopathy resolved in 5-6 days

coronary spasm; STEMI COVID vaccine induced; slight 1-2/10 substernal chest pain on/off; fever of 101 to 101.7; diffuse severe muscle aches; tachycardia of 110 to 130; painful lymphadenopathy of the ipsilateral axilla and clavicular lymph node (LN); This is a spontaneous report from a contactable physician (patient). A 45-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL0142), via an unspecified route of administration in the left arm on 13Jan2021 at a single dose for COVID-19 immunization. The patient's medical history included benign prostatic hyperplasia (BPH). Concomitant medication included alfuzosin. The patient previously took the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899) in the left arm on 23Dec2020 16:00 at the age of 44 years old for COVID-19 immunization. On 14Jan2021, the patient started having fever of 101 to 101.7, diffuse severe muscle aches, and tachycardia of 110 to 130. Thursday evening (14Jan2021) through Sunday (17Jan2021), the patient also had painful lymphadenopathy of the ipsilateral axilla and clavicular lymph node (LN). Thursday evening (14Jan2021), the patient had slight 1-2/10 substernal chest pain on/off. Friday evening around 23:30 (15Jan2021), the patient had chest pain substernal 7-8/10 that lasted for one hour. The burning sensation was worse with cold air. It resolved with paracetamol (TYLENOL) and ibuprofen. Monday early morning at 04:00 (18Jan2021), the patient experienced STEMI COVID vaccine induced wherein the patient woke up with 10/10 chest pain and shoulder pain which lasted for 30 to 40 minutes and resolved with paracetamol and ibuprofen. The patient also decided to check blood work Monday morning (18Jan2021) while in the hospital. Trop came back 16.28 ng/ml. This is the old trop not high sensitivity. Normal high is 0.30 ng/ml. The patient went to the hospital. ECG showed ST elevation inferior lead. Left heart catheterization was done. The patient have clean coronaries. No evidence of any atherosclerosis. Echocardiogram showed normal EF. No wall motion abnormality. It was concluded that the patient also had coronary spasm. The patient underwent other lab test and procedure which included nasal swab COVID test showed negative on 18Jan2021. Outcome of the lymphadenopathy was recovered on 17Jan2021, of the chest pain was recovered on Jan2021, of the coronary spasm and STEMI was recovering, while of the remaining events was unknown. The events coronary spasm and STEMI resulted in hospitalization and life threatening illness.; Sender's Comments: The reported coronary spasm with chest pain and suspected STEMI were likely related to the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) due to plausible temporal relationship, and no evidence of any atherosclerosis during left heart catheterization. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

approximately 30 minutes after injection of shot, felt dizzy, confusion, face and throat swelling, rapid heart rate, feeling on the verge of passing out. Was driving home at the time and pulled over to call 911. 3 to 4 minutes of very intense reactions, had initial difficulty calling 911 and driving off the road to pull over. Paramedics arrived 10 minutes after the initial call to 911, symptoms had improved greatly after 3 to 4 minutes and after 10 was starting to feel back to normal.

Rash to groin, legs, parts of torso; swelling to hands, feet and legs; This is a spontaneous report received from a contactable nurse (who is also the patient). A 45-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3302, expiry date: unknown), intramuscular in the right arm, on 14Jan2021 07:45, at single dose, for COVID-19 immunization, in the hospital. Medical history included hypertension. The patient has no known allergies. The patient did not have COVID-19 prior to vaccination. Concomitant medication included losartan potassium (COZAAR). Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899, expiry date: unknown), intramuscular in the right arm, for COVID-19 immunization. On 16Jan2021 at 06:00, the patient experienced rash to groin, legs, parts of torso and also swelling to hands, feet and legs. No treatment was given for the events. The patient was not tested for COVID-19 post vaccination. The outcome of the events was unknown.

1. Moderate Pain Site of the Injection (started 12 hours after injection) lasted (4 days) 2. Painful Lymph-nodes : Location Right cervical , Right side supra clavicular and infra clavicular , lasted for 1 week 3. Light headed lasted 2 days 4.nauseas lasted 3 days 5 diarrhea mild lasted 2 days 6. Chills , lasted for 3 days 7 weakness , lasted 10+ days

Profuse sweating followed by headache and numbness to my head. After a few minutes my tongue began to swell followed by my lips and face. Was given 50mg PO Benadryl five minutes later a shot from an EpiPen. Trip to ED via ambulance IV Benadryl and Solu-Medrol was administered. After 3 hrs all swelling was gone and was discharged.

Pt received vaccine on 1/22/21. On 1/31/21 he presented to urgent care with fever and morbiliform rash. He tested negative for the flu and was given empiric oseltamivir. He had persistent fever and was given doxycycline and ceftriaxone by urgent care on 2/2. On 2/4 at urgent care he was noted to be hypotensive and referred to ER. He had findings of cardiogenic shock and intra-aortic balloon pump was placed. He was treated for acute heart failure with improvement in symptoms. He was also treated for pneumonia with piperacillin/tazobactam as well as amoxicillin / clavulanic acid. He was discharged with resolved fever, resolved rash, and improvement in EF based on cardiac MRI. Workup for other viral causes of myocarditis was negative.

large mass under the armpit. possible swollen lymph nodes. muscle pain, fatigue, tingling feeling on the lower lip left hand side,

Went into anaphylactic shock with 5 minutes. Throat started to itch, ears were popping and the left side of my face began to feel pressure. My wife injected me with my EpiPen. Within 10-15 minutes, the symptoms began to recede.

Complaint of "tingling" and "feeling" of edema in lips. Patient subsequently went to the bathroom to see if his lips were swollen and they were not. Paramedic reported that the patient expressed anxiety about injections/needles and this may have contributed to perceived adverse effects. Patient asked for Benadryl and was given 25 mg po x 1.

Fever over 100.8, server body ache, swollen on arm, lump size of fist under my arm, vexation pain , shortness of breath

Right ear pain started on the Wednesday afternoon, two days after Vaccine shot. By Friday evening the ear pain was intense and it had moved below the ear to lymphnode area. Saturday, his ear was really swollen and red. He went to the Urgent Care and they prescribed an antibiotic Cephalexin thinking it could be some sort of ear infection or insect bite. Sunday morning he woke up with his face droopy. We tried to get an appt. with Urgent Care, but they sent us to the ER. The ER did a physical assessment and concluded he had an ear infection and Bells Palsy. The prescribed another antibiotic Doxycycline, an antiviral Famciclovir and a steroid of prednisone. By Monday he was extremely nauseas and had started having vertigo. We went to Urgent Care and they prescribed him Ondansetron for nausea and made the assessment that he had Shingles in his ear. We saw PCP on Wednesday and he assessed that this was a zoster ear infection causing facial paralysis and vertigo, also known as a rare condition called Ramsay Hunt Syndrome and that it was most likely attributed to his Covid vaccine shot and not to get the second vaccine shot. The Dr. took him off the antibiotics and put him on a higher dose of prednisone, a different antiviral (valacyclovir) and Meclizine for vertigo symptoms. He sent referrals for Neurology, ENT and Eye Dr. He saw the Neurologist that Friday and he concurred Ramsay Hunt Syndrome, most likley from Covid Vaccine and do not get the second vaccine shot. The neurologist referred him to Physical Therapy to treat his vestibular issues. He ordered an MRI and some blood work. We are still waiting for the results. We saw an ENT an he had him have a hearing test which showed moderate high frequency hearing loss. The ENT prescribed Gabapentin for the ear and face pain. He started to see a physical therapist this week, he had his MRI on Wednesday and we see the ENT again on Monday. He has no improvement yet, other than the nausea has subsided.

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

Swollen gland in the neck, sore throat (left side), ear pain (left side), and swollen lymph node in armpit (left armpit)

shot occurred on 1 MAR. swollen lymph nodes in the right armpit began to be noticeable around 3 MAR. Pain and inflammation in left arm pit did occur off and over the next two weeks. Blood work and revealed no significant issues. Follow on ultrasound 23 MAR still showed some inflammation and sensitivity. by today, 30 Mar the majority of the swelling is gone and pain has dissipated.

sore arm, brain fog, headache, swollen lymph nodes, pain in brain stem, sore neck, lethargy, diarrhea, bowel discomfort, arthritis flare-up

Day 2 in the evening, noticed pain under left arm and my lymph node was swollen to about an inch high and 3 inches in diameter. It is painful to the touch.

patient called to report that not right after his shot but later that night when he was going to bed his throat started closing up and he couldn't swallow. Pt proceeded to the emergency room where he received treatment for anaphylactic reaction. Patient states he is better now.

Axillary lymphadenitis tender (Swell at armpit) seen on my left hand, where I received my second shot (Pfizer). Consulted my primary care doctor around 10;30 am today and he prescribed antibiotic.

Fever (100.4F), chills, and muscle ache started within 24 hours and lasted for one day. Took Tylenol which eliminate the fever and all the aforementioned issues were resolved. The second day noticed swollen painful lymph nodes on the right side of my collarbone (same side of the injection). The issue is still ongoing. Currently, I am taking Ibuprofen and using warm compression to alleviate pain.

3/28/21 Patient presented to ED w/SOB x 5 days, fever and cough for one day. RA pulse ox 42%. CXR showed bilateral infiltrates. Pt refused intubation and was started on BiPAP w/FiO2 of 100%. Given Remdesivir and Decadron. Was placed in ICU. Also covered with zithromax and rocephin which was stopped after procalcitonin found to be normal. 4/1 Pt was weaned off BiPAP to HFNC 4/3 Pt was weaned off HFNC to 4L per NC. From 4/3-4/5 he had significant improvement. On 4/5 did not require O2 at rest but still had desaturation to 88% with ambulation. The team wanted to keep him an additional night but he demanded D/C. He finished 5 day course of Remdesivir prior to D/C and was to finish 10 course of Decadron after discharge

2 days after my second shot I broke out in Hives and welts down my torso, Arms, and legs. I went to urgent care and they gave me a shot of prednisone and gave me a pack of the same steroid to take over the next 6 days they also prescribed some prescription Claritin and Famotidine.. The following day 4/16/21 around 1130pm I woke up to my face being swollen as well as my tongue. I was taken to the ER where the triage unit gave me epinephrine as well as another steroid to stabilize the swelling as I was having trouble breathing. Once stabilized I was released and took 50 mg of Benadryl every 6 hours as well as the Claritin, famotidine, and the prednisone. I had hives for a few days after and followed up with my primary doctor, but as of today I feel like i am back to normal.

Swollen gland / node in left armpit. Painful to touch, approximately half the size of a golf ball. No treatment yet, except for warm compresses and OTC pain reliever.

Per MD, Pt c/o swelling in the roof of his mouth about 3 minutes after receiving the vaccine. No itching, no SOB. Exam NAD 145/93 P88 O2sat 100%, Lungs CTAB This represents possible angioedema and I recommend that he forego the second dose of Pfizer. Pt provided with 25 mg of benadryl PO x1. He was d/ced home in stable condition. Cancelled 2nd dose and made appointment for Johnson & Johnson vaccine.

fever and malaise began 4/12/21 followed by migratory headaches and myalgia, several days morbilliform rash, brief diarrhea and abdominal pain

Lymph node on right side behind ear swelled up then entire right side of face and ear swelled up to the point I had water blisters on ear eye swollen shut and ear was so swollen couldn?t even put a Q tip in my ear nose swelled all up

Started with break out on scalp, Then lymph Nodes swollen in neck area. then turned into hives break out over entire body.

cold sweat; headache; cramping/spasm; bumps on the side of neck; body aches; Bumps on his head that were also painful; stomach cramps; diarrhea; he threw up several times; nauseous; disorientated; just not feeling good at all; tired; neck pain; felt weird; This is a spontaneous report from a contactable consumer (patient). A 45-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; /Lot Number: ER2613), via an unspecified route of administration, administered in right arm on 04Apr2021 (at the age of 45-years-old) at 14:00 as single dose for covid-19 immunisation. Medical history included COVID: he had gotten diagnosed with COVID back in December or January and twice tested positive for covid and his body had fought it off (as reported). Medical history included also back pain Concomitant medication included diphenhydramine hydrochloride (BENADRYL) taken to sleep, start and stop date were not reported. The patient reported that around the night of vaccination he experienced cold sweat, headache, and cramping for several hours then subside and come back later. Patient had some bumps appear on the side of his neck. He stated that he could not say that's from the shot, something may have bit him. The patient did bump his head a chandelier and went to the ER. He received Ibuprofen for the symptoms. Patient stated that the reported events occurred the same day as his COVID Vaccine and began a couple of hours later and wakes up every night in a cold sweat; stated he was in and out of the emergency room in about an hour and they gave him Ibuprofen 400mg and a of nights had to take two Ibuprofen because his head and body was hurting so bad and he had to take some kind of relief and he does not like taking stuff like that and pain pills make his stomach hurt. Patient stated he did a whole Ibuprofen and did not feel good after that and can't take the Ibuprofen anymore and then took 1-2 Aleve after that and does not like taking pain medication. He stated he was healing with the bumps but had this every day since the Pfizer Vaccine and he was starting to heal but the bumps were still there on the side of his neck and were improving and healing and he had the bumps on his head that were also painful; states the bumps occurred the same day as his Pfizer COVID Vaccine; states he was up in his attic and could have gotten into a spider nest and might have poison in him from the spiders and then went to the hospital emergency room with these issues. States he told the emergency room about the bites and bumps and that he had the Pfizer COVID Vaccine and they gave him the Ibuprofen and sent him home. The patient stated that this was a real concern for him due to the blood clots stuff coming out about how people have different reactions after a vaccine. States he felt like the hospital did not even do anything; he could have hit his head a couple of times on a chandelier; states the emergency took an image of his head and they did not address the bumps or anything else and said his head was not bleeding and gave him Ibuprofen and he did not think you should take Ibuprofen like when you have COVID and they sent him home and nothing was done. Caller states he does not know but when he received the Pfizer COVID vaccine he noticed a patch of bumps in his neck, and his neck got really tight and his neck still hurts on the left side; states he could have gotten bitten by something. The patient reported that after he had the Pfizer COVID vaccine, he was waking up every night with cold sweats, and recently last night had extreme cramps in his stomach area like was crawling around the floor getting away from the pain and is still having abdominal cramps. He ate a burger and had extreme cramps and diarrhea for days and this was after his Pfizer COVID vaccine and he is doing this again with stomach cramps and diarrhea; he can't distinguish what the cramps and diarrhea were from and maybe he ate something bad and is confused about his body; states the cramps are way worse and the diarrhea began after the burger. States the diarrhea is a lot and this time is less diarrhea but more abdominal cramps and he threw up several times last night and did not throw up a lot but was so nauseous and threw up twice a little bit. Patient stated that the reported events were just like when he had covid and after waking up at 12:00 he had body pains and was not able to go back to sleep until 4:00; states he had pretty bad headaches which are ongoing and had had headaches ever since he was diagnosed with COVID, stated it is the same thing also as when he had covid; states with covid he got sick and was up from 12:00 4:00 and had fatigue, had body pain, had headaches and nausea and then it got better and he started sleeping through the night. States the Pfizer COVID shot and it was like the same all over again where he was up from 12:00 4:00, had pain and was disorientated, just not feeling good at all which has gone on since the shot; states there were two nights where he slept through the night and was up in a cold sweat which wakes him up and drenches him head to toe and he has to get out of bed to change clothes and sit there til he is tired again and sometimes goes to sleep in the chair and then sleeps ok. Patient stated he took Benadryl just to sleep through the night and did not and got up once and then went back to sleep. He stated on the left side where the headaches were and he had neck pain and it was kind of the left side and felt weird. The patient stated also that in the emergency room he was given Valium in his arm and also has a knot on the back of his neck and tried to address it with the emergency room and they said it was a spasm and did not seem concerned and it felt hard and not a bump under his skin in his neck and it just felt like maybe a pea sized hard knot and noticed this after his Pfizer COVID Vaccine. Caller stated he actually felt pretty good and was sleeping through the night after he had COVID and felt back to normal and then after his Pfizer COVID vaccine everything went downhill. The outcome of events was unknown. No follow-up attempts are needed. No further information is expected.

Chronic hives that moves around whole body, neck, shoulders, arms, legs, stomach, back, hands, and feet. Itches, red swelling and little raised bumps. Comes and goes. Been a month and hasn't gone away yet.

Anaphylaxis with swollen lips; Anaphylaxis with swollen lips; felt like throat was closing; difficulty breathing, could not take a deep breath; This is a spontaneous report from a contactable consumer (patient). A 45-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 13Apr2021 at 12:00 (Lot Number: ER8B2) as SINGLE DOSE for COVID-19 immunization. Medical history included possible rheumatoid arthritis from an unknown date and allergy to poultry from an unknown date. There were no concomitant medications. No other medications were received by the patient within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. On 13Apr2021 at 23:00, the patient experienced anaphylaxis with swollen lips and reported that he felt like his throat was closing and had difficulty breathing, could not take a deep breath. The patient went to emergency room as well as the physician office for the reported events. As therapeutic measures multiple Intravenous (IVs), oral benadryl and steroids were taken by the patient for the reported events. The outcome was reported as recovered with sequel for the reported events.

Patient reported that he woke up the day after vaccination with a slightly swollen, tender area about 1 inch X 1/2 inch on the inner aspect of his left leg below the knee (lateral calf muscle). Fearing he had a deep vein thrombosis, he called the ER. I took the call and agreed with the need for evaluation. At the ER he was examined by a physician. No radiology or laboratory tests were performed. He was released with a prescription for Motrin, PO, prn. Follow up call to the patient today (36 hours after discovery of painful area and 56 hours after vaccination) the patient reports no improvement and no worsening of the painful area.

From hospital discharge summary: "45 y.o. right-hand-dominant male who presents with few hours of improving left arm heaviness/left hand cramping in the setting of getting his second Pfizer COVID-19 vaccination in his right arm 3 days ago and 3 weeks of mildly increased exercise/intermittent fasting. The patient reports getting his first Pfizer COVID-19 vaccination on April 7, 2021. Reports some mild symptoms afterwards. Around that same time, the patient reports having a checkup with his primary care doctor that was notable for a cholesterol elevation to 200. This prompted him to try and lose weight including intermittent fasting and increase in exercise, especially for exercises and cardio. The patient reports approximately 20 pound weight loss over the past 3 weeks. 3 days ago, the patient reports getting his second Pfizer COVID-19 vaccination in his right arm. Reports fever (maximum 103 Fahrenheit) and mild headache the subsequent 2 days after the vaccine. Last night, the patient went to sleep on his left side at around 8 PM. He woke up at 4 AM with significant left arm heaviness and left hand cramping. He tried to massage his hand with some slight improvement of the symptoms but otherwise the symptoms persisted. Hence, this morning, he called his PCP, who told him to come into the ER for further evaluation. Here, the patient reports improving left arm heaviness/left hand cramping. He also does report family history of heart attack and an uncle at a similar age and massive heart attack of his grandfather in their 60s. He denies fever, anorexia, unexpected weight change, headache, blurry vision, sinus pressure, cough, hemoptysis, orthopnea, PND, SOB, DOE, chest pain, pleurisy, changes in taste/smell, N/V/D, abdominal pain, flank pain, urinary sxs, genital sxs, black stools, incontinence, absence of flatus, calf pain, leg swelling, numbness/tingling, streaking redness/rash/skin changes, easy bruising. Also, deny history of HTN, DM, smoking, prior MI, prior PCI, prior CABG, prior TIA/CVA, or history of PAD. Further, denies recent trauma/fall, history of cancer, blood thinner use, recent drug use, recent travel, sick contacts, family history of connective tissue disease/congenital aortic anomaly, or family history of similar sxs. --- Hospital Course by Problem # Troponinemia (Likely myopericarditis) The patient has a family history notable for MI and CABG in relatives aged 50-70 on his mother's side. The patient notes that most of these family members were heavy smokers and drinkers, which he is not (never-smoker, rare EtOH, never illicit drugs). His symptoms are notable for L arm heaviness/cramping that began around 8pm on 4/30/21 at 9/10 severity and subsequently was 3-4/10 severity on presentation to ED and is 0-1/10 severity at time of admission to the floor; he has no associated numbness, weakness, coolness, or pallor. His symptoms are non-exertional. He denies CP, SOB, lightheadedness, nausea, jaw pain, abdominal pain, fatigue. He noes that he recently got the second COVID shot in the R arm, and had a post-vaccine course notable for Tmax 103 ~3d ago and 101 as recently as yesterday. His EKG was notable for ST-elevation in II/III/aVF and his troponins were elevated 305 -- > 298 -- > 328. Of note, his CRP was elevated at 69. The patients symptoms and findings could certainly be compatible with atypical ACS and, given the low risk of bleeding associated with heparin, he was treated conservatively upon admission with heparin infusion, metoprolol tartrate 6.25mg q6h, atorvastatin 80mg (he received ASA 325mg in the ED). However, given his recent covid vaccination and elevated CRP and reported fevers, this could also be compatible with myocarditis or other inflammatory etiology. TTE on 5/3 demonstrated preserved EF 55% with no WMA. Given reassuring TTE, a cMRI was ordered to assess for myocarditis vs scar tissue from recent ischemic event. Cardiac MRI on 5/5 was notable for finding consistent with myopericarditis (see below). Aspirin and atorvastatin was stopped on discharge. Patient was discharged with metoprolol 25 mg daily."

Started with flu like symptoms, after 3 days my left arm would swell slightly, become red/warm, and itchy at injection site. At 1 week I began feeling extremely worn down, exhausted, short of breath after moving at all, coupled with a slight fever and continuous nausea.

Rash, itching, swelling, pain Diagnosed with Herpes Zoster - Shingles on 05/29/21 at same medical facility Treated with Rx medicine Valacyclovir

On April 7, I received the first Pfizer vaccine, on April 9 my left knee started to hurt, on April 10 I had to go to an urgent care because my left knee hurt and I was limping, on April 11 In April I went to the emergency room because I had a very strong pain in both legs, I could not walk and a severe headache, I also had a fever. On Monday the 11th they operated on my left knee because there was a lot of inflammation, that same day the second knee became inflamed, I was hospitalized from April 11 to 17 with a lot of pain in both legs. On April 21 I continued with a lot of pain and swelling in both legs and even in the ankles there was swelling. A rheumatologist doctor, because of the laboratory tests she conducted, did come to the conclusion that it was reactive arthritis caused by the Pfizer vaccine. Today June 1, 2021, I still have pain in both knees and ankles, especially the right one, both knees and the right ankle are a little swollen, until May 24 I walked with a walker and I did it with too much pain.

-tightness in inner thigh- day or so after first dose -tightness in calf worsened over the course of a couple weeks -swelling and soreness in calf gradually increased until doctor visit -doctor visit and ultrasound found multiple blood clots in mid thigh and calf -doctor prescribed blood thinner -continued swelling and tightness in thigh and calf

Lymph node swelling. It started on his left side then it spread all over; Nausea; Fever; Lymphedema in some areas; believes the vaccine went into his lymph node/lymph system instead of the muscle tissue in his arm; ER doctor believed the caller had a hernia due to the swelling in the lower abdomen; ER doctor believed the caller had a hernia due to the swelling in the lower abdomen; This is a spontaneous report from a contactable consumer, the patient. A 45-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0182; Expiration Date: Aug2021, NDC number: unknown) via an unspecified route of administration, administered in left arm on 19May2021 at 13:00 as 2ND DOSE, SINGLE DOSE for COVID-19 immunization. Medical history included sinus infection in 2011 (for which he visited a doctor 10 years ago to get an antibiotic). Other than that, he was healthy. Patient had no family history. The patient's concomitant medications were not reported. Patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER8735; Expiration Date: 31Jul2021) via an unspecified route of administration, administered in Arm Left on 28Apr2021 13:00 as 1ST DOSE, SINGLE DOSE for COVID-19 immunization. Patient had no problems after first dose. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. 6 hours after vaccine, the left side blew up. About 12 hours after the second shot in the middle of the night, patient had the initial reaction and pretty normal side effects (little nausea and fever). Patient had a lymph node inflammation/swelling, which was severe on his left side including his arm pit, down his side, even down into his groin. The reaction died down after about 2 days but spread to rest of the body. On 28May2021, Friday of last week (about 10 days later), everything just blew up. Every one of his lymph nodes went crazy. So many were down in his groin area, the lymph nodes blew up so badly. It was putting enough pressure in that region, it was cutting off circulation to his manhood. Patient had to go to the hospital around 1:00AM. Patient was diagnosed finally at 04:56 and clarified it to be an emergency room visit. Patient was seen in the ER for about 3-4 hours. He was never actually admitted into the hospital. ER doctor believed that patient had a hernia due to the swelling in the lower abdomen. Patient did not know all the tests that were done in the ER. When patient mentioned the swelling that cut off the circulation to manhood, the ER doctor had them ultrasound his manhood, but the doctor never actually listened to the patient. The doctor basically did not want to hear that there were any problems with the vaccine. Patient felt that administration led to lymph node reaction. Instead of sitting in arm for a couple of days or going into a fatty or muscle tissue, vaccine went into the lymph system and now his lymph system was going crazy. He believed this one time when the person jabbed the COVID vaccine in and squeezed the plunger, it put the product right into a lymph node and all of it right into the lymph system. Patient never had a lymph node problem. Patient still had severe lymph node problems. Patient was getting lymphedema in some areas. The only reaction that was abnormal was the extreme lymph node swelling. Outcome of the events was unknown. Investigation Assessment: Yes

15 - 20 min post vaccine, patient complained of bilateral hand/feet tingling/numbness. Vague heaviness across chest and throat. Feels warm and anxious. Treated with diphenhydramine 25 mg po x 1, diphenhydramine 25 mg IV x 1, Diphenhydramine 50 mg IV x 1 (had developed angioedema/throat swelling). Admitted to hospital and then transferred to another facility.

I have had hives ever since first shot in April and they have not stopped. Flares ups have slowed down, but are very much persistent. Hives cover hands, arms, back, buttocks, chest and feet. I had swollen lymph nodes near base of neck and shoulder blade.

Swelling of lymph nodes for two months, First time treated with Predisone and Naproxin to combat severe pain in back and knee. Recently within the last month Ultrasound performed and I experienced full body pain and weakness. Treated with Augmenton and narco.

extremely congested; right wrist and forearm swollen; red and swollen; allergic reaction to the vaccine/histamine reaction; left side of his face swollen and puffy in lips, chin and cheek; left side of his face swollen and puffy in lips, chin and cheek; left hand swollen and itchy/forearm swollen; left hand swollen and itchy; allergic reaction to the vaccine/histamine reaction; This is a spontaneous report from a contactable consumer (patient). A 45-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 23May2021 12:50 (at age of 45 year old, reported as "was Given: 12:50pm, right before 1:00pm", Batch/Lot number was not reported) as a single dose for covid-19 immunization. The patient not had medical history and family medical history. There were no concomitant medications. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in left arm on 02May2021 12:50 (at age 45 years old, reported as "was Given: 12:50pm, right before 1:00pm", Batch/Lot number was not reported) as single dose for covid-19 immunization. Patient had the second dose of the Pfizer COVID-19 vaccine last Sunday (23May2021). Since then, he thinks he had an allergic reaction to the vaccine. On 26May2021 (Wednesday late morning, early afternoon), he woke up and the left side of his face was all swollen and puffy in the lips, chin and cheek. It started out in the lower cheek and then kind of spread through out the day. It eventually went down to the lower lip on the left side and moved up to the upper lip on the left side. His face was still swollen but to a much less degree. He took Benadryl and it kind of went away and was getting better. His left hand was all swollen and itchy now. It started after but was simultaneous with the face swelling. On 27May2021, he woke up this morning and his right wrist and forearm was swollen. Not really a rash but was red and swollen, and looks like a histamine reaction. Right wrist and forearm swollen was reported as worsened. He had been extremely congested the past 2 days. Was extremely congested with 99 percent blockage. He took Afrin which knocked it out. It was better but he was still very congested. No physician office visited. He was at Urgent Care right now. The outcome of the events "left side of his face swollen and puffy in lips, chin and cheek; extremely congested" was recovering. The outcome of other events was unknown. Information on lot/batch number has been requested.

Head ache; Muscle ache; Malaise; Fever; Chills; Swollen lymph nodes; Runny nose; Sore throat; Coughing up greenish/brown phlegm; Sinus congestion; URI; This is a spontaneous report from a contactable consumer. A 45-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP7534) via an unspecified route of administration, on 17Mar2021, at 11:00, (at the age of 45 years), on left arm, as a single dose for COVID-19 immunisation. Medical history included Crohns, colitis and allergy to gabapentin, Lyrica and pecans. Concomitant medication was not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6202) via an unspecified route of administration, on 24Feb2021, at 11:00, on left arm, 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. On 18Mar2021, at 03:00, the patient experienced head ache, muscle ache, malaise, fever, chills, swollen lymph nodes, runny nose, sinus congestion, sore throat, and cough. These have turned into an upper respiratory tract infection. The patient had sinus phlegm that was green/brown. It had now started to set up in the patients chest and the patient was coughing up greenish/brown phlegm. The treatment received as a result of events included unspecified antibiotics and the events resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of head ache, muscle ache, malaise, fever, chills, swollen lymph nodes, runny nose, sinus congestion, sore throat, upper respiratory track infection, and cough were recovering. No follow-up attempts are needed. No further information is expected.

Site: Swelling at Injection Site-Mild, Additional Details: came for second dose vaccine on 7/5.reported swelling under right armpit area/side of breast that appeared 3 days after receiving first dose and that this has happened to him once in the past as well. Pt went to md for visit and was told it was nothing and gave abx which he didnt take.Swelling noticeable, but does not cause pain/affect his daily activity.RPh asked patient if he wants to get it checked by his pcp before receiving second dose, pt refused and wanted 2nd dose.monitoring 30mins

pain and swelling in arm where hadinjection; pain and swelling in arm where hadinjection; Feeling tired; This is a spontaneous report from a contactable consumer. A 45-year-old male patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: unknown), via an unspecified route of administration in the left arm on 22Mar2021 at 14:00 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure. The patient did not have 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 did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient did not receive any medications within two weeks of COVID-19 vaccine. On 22Mar2021 at 14:00, the patient had experienced pain and swelling in arm where the patient had injection and was feeling tired. The patient did not receive any treatment for the adverse events. Adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. The clinical outcome of the events pain and swelling in arm where had injection and feeling tired was resolved on an unspecified date in Mar2021. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Swollen lymph nodes in neck opposite side of injection; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm right on 01Apr2021 at 10:15 (at the age of 45-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient received unspecified medication within two weeks of vaccination. The patient had no known 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 did not receive any other vaccines within four weeks prior to the vaccination. On 01Apr2021 at 20:00, the patient experienced swollen lymph nodes in neck opposite side of injection. 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 recovered. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Extreme pain and swelling in lymph under right arm; This is a spontaneous report from a contactable consumer, the patient. A 45-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 02Apr2021 at 14:00 (at the age of 45-years-old), as a single dose for COVID-19 immunisation. Medical history included seasonal allergy, asthma and osteoarthritis. The patient was allergic to iodine dye. Concomitant medications included ranitidine hydrochloride (ZANTAC), omeprazole (PRILOSEC), bupropion hydrochloride (WELLBUTRIN), desvenlafaxine succinate monohydrate (PRISTIQ) and gabapentin (MANUFACTURER UNKNOWN), all taken from unknown dates for unknown indications. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 12Mar2021 at 14:00 (at the age of 45-years-old), as a single dose for COVID-19 immunisation. On 03Apr2021 at 09:00, the patient experienced extreme pain and swelling in lymph under right arm. The events 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 experienced. The clinical outcome of the event extreme pain and swelling in lymph under right arm was not resolved at the time of this report. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Some lumps have shown up in veins noticeable in hand veins; Swelling of lymph nodes near throat.; Bothering of lymph nodes near throat; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via an unspecified route of administration in the left arm on 18Mar2021 at 16:15 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient was not allergic to medications, food or other products. The patient did not receive any medications within two weeks prior to the vaccination. The patient did not received any other vaccines within 4 weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 21Mar2021, the patient had some lumps which had shown up in veins noticeable in hand veins and swelling of lymph nodes near throat which was bothering. The patient did not receive any treatment for the events. The clinical outcome of the events some lumps which had shown up in veins noticeable in hand veins and swelling of lymph nodes near throat which was bothering were not resolved at the time of this report. No follow-up attempts are needed. No further information is expected.

He stated he was fine for 20 minutes after the administration, but noticed driving home that the left side of his face felt funny/tingly. He says it progressed that evening to numbness and states his spouse noticed slight swelling to his face. He also complained of pain to his teeth and gums. He voiced concerns about bell's palsy, but stated he didn't notice any asymmetry or paralysis in his face and his symptoms have resolved entirely as of today 1/4. He was never seen or evaluated while he was having symptoms, unfortunately, and was able to continue working. Denied chest pain or difficulty breathing, no rash. He reports self-medicating with prednisone on sat/sun with improvement and as mentioned, is now asymptomatic.

Severe allergic reaction; BP of 170/104; felt like his whole body was on fire; chest tightness; HR elevated at 110bpm; Severe allergic reaction with symptoms that include/ rash all over his body including his throat, chest, and inner legs.; Right side of neck was swollen and sore; Right side of neck was swollen and sore; his neck was stiff to turn; he feels "really weak and tired"; he feels "really weak and tired"; This is a spontaneous report from a contactable other healthcare professional. A 46-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date unknown) via an unspecified route of administration, on 29Dec2020, at a single dose, for COVID-19. The patient's medical history and concomitant medications were not reported. Patient is a 46y/o male certified nursing assistant (CNA). He received his first dose of Pfizer-Biontech Covid19 vaccine, yesterday 29Dec2020. On an unspecified date in Dec2020, patient experienced severe allergic reaction with symptoms that include: felt like his whole body was on fire, chest tightness, BP of 170/104, HR elevated at 110 bpm, rash all over his body including his throat, chest, and inner legs. Right side of neck was swollen and sore. Both sides are swollen, today, and his neck was stiff to turn, he feels "really weak and tired". Patient was taken by ambulance to the emergency room. Patient then asked if he should get the second dose of the vaccine. Outcome of the events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of severe allergic reaction with multiple symptoms cannot be excluded, considering the plausible temporal relationship and the known adverse event profile of the suspect product. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

subject developed hives/itchy bullae over trunk and extremities. over the next few days, despite using diphenhydramine, also had swelling of lips and sensation that his throat was closing. Voice was slightly hoarse. Was seen in clinic and ER. was given steroids.

Fever of 101.7 until 2/1/21 Blood pressure 169/110(with meds taken) Swollen lymph nodes under arm of shot site(to date) Stiffness in said arm Joint pain on left side of shot site

At 1700 01/10/2021, he began to feel numbness in his left lip, like he was given a numbing shot at the dentist. Over the next hour, it traveled superiorly up to his left cheek and to the inferior ear. He had a steroid and antihistamine sent in to the pharmacy and took this once he got home about 1930. Shortly thereafter, he started developing tongue numbness. He woke up in the middle of the night to use the restroom and reports he nearly fell into the bathroom wall due to the intensity of vertigo he was experiencing. The vertigo worsened throughout the day and he is very unsteady on his feet, requiring assistance and support from his wife to ambulate. He is unable to drive and reports exacerbation of dizziness when moving his head side to side. His wife reports he had a fever throughout the night 01/10/2021-01/11/2021. He feels the left eye is dryer and a bit weaker than usual and he has had to administer drops to help keep it moist.

Possible symptom 1: Within approximately a day or two of the shot, I developed a severe and persistent lower abdominal/groin pain. The pain was very pin point in location and lasted for approximately 10 days before easing up. Very small isolated pain severe enough to go to the DR, but I could not afford to on account of my wife having severe unknown abdominal pain and being in the ER and DR multiple times herself (she got the same vaccine an hour before me?). Possible symptom 2: 4-5 days after the shot I developed an isolated and severe pain in a preexisting nodule/mass (lymph node?) located on my mid right thigh, it has never had any sensation before. The pain was persistently severe for approximately 7 days before easing up.

Swollen lymph node under left arm; This is a spontaneous report from a contactable consumer (patient) A 46-years-old male patient received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine, Lot number EL8982, in Hospital, via an unspecified route of administration in right arm, on 18Jan2021 (at 46 years of age) at single dose for COVID-19 immunization. Medical history included seasonal allergy (pollen) and allergy to cats, both from an unknown date. The patient has not been tested for COVID-19 since the vaccination. Concomitant medication included Vitamin D3 and Multi vitamins. On 27Jan2021 the patient experienced swollen lymph node under left arm. No treatment was administered for the event. The patient was recovering from the reported event at the time of the report.

1. Minor headache 2. Moderate pain in left underarm. Minor swelling of lymph node in the same area. I feel discomfort when trying to place my arm against my body. I have to keep arm extended to avoid discomfort.

started with slight pain in left cheek and then had swelling with no pain. started approximately 3 hours after injection.

Shortly after the vaccine confusion and hard time focusing along with fatigue, muscle aches, chills, and swollen glands around his neck,

Inflamed and painful lymph nodes in armpits, on breast bone and on ribs the the same side of body as injection.

I woke up on 1/9/2021 with my lower left leg swollen and red and DR said it could be a superficial blood clot. January 9 - ER - Diagnosed cellulitis - round of Ceflex for a week - things got worse. Since January 9, I've had two other separate ER visits and three rounds of CEFLEX. Was referred to Dermatology - Arrhythmia Nodusem - so now I'm off Ceflex and on a steroid regimen now. I just started it today. It hurts to even touch my skin and it hurts to walk.I'm in a lot of pain. I have no open wounds so no reason for this to happen.

Tiredness, headache, muscle pain, chills, fever, feeling unwell, and swollen lymph nodes. Ongoing for the last 6 days

Left arm lymph nodes are swollen and painful. My entire arm hurts down to my fingers. Diarrhea, body pain and fatigue.

Within an hour of receiving the vaccine I felt a sharp pain shoot down the back of my knee to my heal. I continued to work with the pain. The next day my knee and calf was sizeably larger. I went to the urgent care on March 19, 2021. Then to the Emergency room on March 20, 2021. They performed an ultrasound of my leg and found a blood clot. It is in a superficial vein. Followed up with a vein doctor and will go again in three months for another follow up.

Woke up at 3/29/2021 with severe itching, flat reddened patches on arms, chest, back and legs. I also had and raised reddened (pea to dime sized) hives on my arms, legs and chest. I thought that it was an allergic reaction to several insect bites from being outdors Sunday evening for about an hour. Allegra and Zyrtec didn't help the itching very much, so I've been taking Allegra every 10 hours and Benadryl every 6 hours for the past 48 hours. When the Benadryl wears off the hives return become raised, red and very itchy. I didn't think that it could be from the vaccine because I didn't really have any issues other than local swelling and itching at the ilocal area of the vaccine njection site. I've also been treating the hives with topical Hydrocortisone cream and Benadryl cream.

Patient developed some swelling in neck 22 minutes after vaccination while driving home. He did not seek any immediate medical attention, but gave himself an epinephrine injection several hours later with full resolution of symptoms

Headache, nausea, cloudy thinking, overall body aches, swelling in neck and under arm pit-breast area on arm where shot was given, fatigue not able to sleep, day 5 and symptoms have continued and are getting worse.

Minor outbreak of Herpes Type 1 (cold sore above lip) Treating with Valtrex at time of second dose of vaccine. Valtrex prescribed by primary care doctor?s covering physician

Patient received COVID immunization #1 on 3/17/2021, then on 4/1/2021 he started having right calf pain and swelling. Got worse over the following 3 days so he presented to Urgent care. DVT was identified in UC on bedside ultrasound, started on Eliquis that day.

11:55 p.m. day of vaccine woke up with severe chills, muscle aches heavy breathing. Under my left arm there is swelling and tender to the touch at that location. 22 hours after vaccination chills subsided, however fatigue, achiness, headaches, chills and swelling under left arm still remain. 38 hours after vaccination headache still persists, chills still come and go, swelling under left arm visible along with headaches

Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Additional Details: patient reported rash/itchiness on the chest area post vaccine shot. does not report any other symptoms and no swelling of the mouth areas (face, lips, tongue). no trouble breathing. patient had also picked up allergy medications earlier in the day for an unrelated allergy symptoms of the body. Counseled patient on benadryl and will follow up next day as well. Patient reported okay to drive home and will take benadryl when he arrives at home safely.

He presented with worsening redness and swelling to his left eyelids. States he received second dose of his COVID vaccine on 4/6 and a rash developed on 4/9, then worsening redness and swelling to the area after taking amoxicillin which was prescribed by an urgent care provider. Therefore, he was advised to come to the ER for further evaluation. He denies any fever or chills. Denies any visual disturbances. He is afebrile. White count is 4000, hemoglobin 13, hematocrit 41. He has been started on intravenous antibiotics, Rocephin and vancomycin. He had a CT of his facial bones, which confirmed left preseptal cellulitis without fluid collection or abscess. Blood cultures are currently pending. Preseptal cellulitis of the left eye. No abscess noted on CT. He received COVID-19 vaccine 4/6. He noticed a rash to his left eye on 4/9, then developed redness and swelling. Denies trauma or insect bites. Questionable if this is related as possible delayed reaction to his vaccine. Brand of Covid-19 vaccine is UNKNOWN.

Patient received #2 of Pfizer COVID vaccine on 2/12/2021, reports that 2-2.5 weeks later he had bilateral leg pain + swelling. He was seen in hospital ER on 3/8/2021 and diagnosed with non occlusive dvt in distal fem vein of Right lower extremity

Developed left arm pain and swelling after 1st vaccine in left shoulder. Persisted longer than previous reactions. Found to have blood clot in left brachial vein on 4/15/21 on ultrasound after evaluation by me

Diarrhea came two days after for four days. Sore arm. Head felt numb-ish, tingly on right side and sore shoulder/arm. Then, small bumps on head and headache. Then, five days or later large bumps formed on head. Top of head, then moved to right side of head, lymph nodes and right side of neck swelling. Very severe head ache 7 days later. Emergency call to doctor and doctor visit. Bumps moving and forming in different areas side of vaccine. Face swelling. Throat swelling...all on right side.

Started with dizziness then anaphylaxis like symptoms and lymph node symptoms of tingling lockjaw hard to swallow very difficult to breathe a little bit of chest pains, called EMS and paramedics to took blood oxygen levels, blood pressure which were all normal by then the symptoms had started to subside

very painful swollen lymph node under arm pit, sometime with sharp stabbing pains that radiates through chest

In my left armpit I experienced soreness and swelling. I first experienced this on Sunday, April 19, 2021 around 8am. As of April 22, 2021 I still have the swelling. My lymph node in my left armpit is still tender to the touch.

Patient presented to the ED and was subsequently hospitalized for 3 days on 1/9/2021. On 1/21/2021 he presented to the ED with rash and hypertension. On 1/23/2021 patient presented to the ED and was subsequently hospitalized for 6 days for SIRS.

Fever - 99 degrees F for about day and a half. Chills - about day and a half. Accelerated heart rate & skipped heart beats, i.e. arrhythmia - for about 7 days but improving each day. Terrible, splitting, constant headache - 2 days. Stuffy nose - 1 day. muscle pain, chest, both shoulders, arms - 4 days. Joints pain - 2 days. Pain in the lymph nodes - 2 days. Pain in the lower back around kidneys - 1.5 days. Fatigue - 3 days Nausea and stomach ache - could not eat protein of any kind, only bread and cheese for 4 days.

Lymph node(s) in left armpit were swollen, red and warm to touch. Infection suspected, but not confirmed by laboratory tests. CEFUROXIME 500 mg 2/day for 7 days was prescribed and taken. Swelling and redness of lymph node(s) returned to normal approximately 48 hours later.

This is a spontaneous report from a contactable consumer (patient's fiance). A 46-year-old male patient received the first dose bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 18Apr2021 11:20 (Lot Number: EW0162) (received at the age of 46-years-old) as SINGLE DOSE for COVID-19 immunisation. Medical history included right knee pain. Concomitant medications were not reported. The patient received the Pfizer 1st shot 18Apr2021 11:20 am. On 19Apr2021, at midnight, he had low grade fever then swelling right leg. On the day of the report, 20Apr2021, he had swelling to both legs. The patient had taken ibuprofen as treatment beside propping legs up. The reporter wanted more information on the swelling and if it's related to taking ibuprofen. It was further reported that the patient experienced severe swelling from the knees down to the calves on both legs on 19Apr2021. He also experienced night sweats, fever, lightheadedness and dizziness on 19Apr2021. They want to know if there are any reports regarding the swelling side effects and if it is from the vaccine. The first dose of the vaccine was given 2 days ago (18Apr2021) and the second dose is due on 09May2021. The patient got his first shot on 18Apr2021 about 11:20am. After about 15 hours he developed swelling in one leg, she later clarified this to be his right leg, and now reports that both of his legs are swollen at the time of report (20Apr2021). She noted that patient told her his legs are not painful. She doesn't know if it's a blood clot or if they needed to go to the hospital. She also wanted to know if there is information about this as a side effects or if other people are having this too. She then reported that the patient started experiencing a fever, profuse sweating, and was spacey about 12 hours after the vaccine, a little after midnight 19Apr2021. She doesn't know if the dehydration made it worse. His fever was low-grade 99.8 degrees and lasted 4 and a half to 5 hours and has now resolved. When asked if patient received any treatment for fever, caller said it was so recent, and that was listed as a common side effect that goes away. Reported the patient drank fluids and she kept an eye on him. Leg swelling was about 15 hours after the vaccine, early morning 19Apr2021. She noted that the swelling in the right leg got bigger and didn't go down, but the left leg did. But today the left was more swollen and more prominent today. She further clarified that the patient takes ibuprofen for pre-existing right knee pain. Caller also reported that the patient propped his legs to alleviate the swelling, it has improved some but the swelling did not go away. The adverse events did not require a visit to the physician office or emergency room. Outcome of the event fever was resolved on 19Apr2021 (lasted 4 and a half to 5 hours); outcome of the event "severe swelling from the knees down to the calves on both legs" was not resolved; outcome of the remaining events was unknown.

4/6/21 called PCP office stating ?Patient called stating since his first COVID 19 vaccine he has had wheezing in his lungs, short of breath on exertion and productive cough. Voice also sounds "harsh" per patient. He has used his inhaler and it is not helping.? Nurse recommended Urgent care tonight. Patient agreed. 4/6/21 went to urgent care. CXR no acute airspace process. COVID-19 PCR: neg. Given Prednisone. Sent home 4/13 allergy appointment cancelled. 2nd vaccine 4/20/21 received. Reports difficulty breathing, dizziness and weakness and headache on survey. Calls Nurse triage 4/20/21 and reports extreme fatigue, headache, nausea, vomiting, and chills. Calls Nurse triage phone on 5/6/21 reporting shortness of breath, phlegm and cough. Recommended to go to ED. Went to ED.

Right submandibular lymph node swelling, facial/ear pain (ongoing but getting better-antibiotics given) Right facial numbness/droop diagnosed as Bell?s Palsy right side (ongoing)

Patient received this Pfizer vaccination outside of this clinic, tolerated first dose with no issues, however 3 days after receiving second dose he had the onset of diffuse erythematous rash covering his legs and arms, he also noted a mild sore throat, but no respiratory distress. he did not immediately seek medical attention but reported symptoms to a doctor friend, who advised benadry, and to seek medical attention. He began taking benadryl 50mg q8 hours and symptoms gradually improved, he later sought care through our clinic and was seen 3 weeks after onset of symptoms. He has been taking Benadryl regularly 50mg every 8 hours which has been effective in controlling symptoms but when he misses dose he experiences recurrence of rash.

Symptoms for 4 days...Pt reported rashes that would come and go every 5 to 10 minutes, itching on hands and feet, itching/burning inside lungs, and swelling of jaw.

PT GOT THE VACCINE ELSEWHERE: PT ALSO STATES, THIS IS HIS 2ND DOSE OF pziefer HE STATES HE HAD PAIN ON BOTH LEGS AFTER A COUPLE OF HOURS OF THE VACCINE TODAY HE COMES IN WITH BOTH FEET SWOLLEN AND PAIN

Swollen and painful lymph nodes in left armpit; Swollen and painful lymph nodes in left armpit; This is a spontaneous report from a contactable other hcp (patient).A 46-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot/batch no: EN6199) via an unspecified route of administration in the left arm on 09Mar2021 at 15:00 (at the age of 46-years-old), as 1ST DOSE, SINGLE for COVID-19 immunization. Medical history of the patient was not reported. Concomitant medications included colecalciferol (VITAMIN D 3,50000 IU) taken for an unspecified indication, start and stop date were not reported; omeprazole (PRILOSEC) taken for an unspecified indication, start and stop date were not reported. The patient did not have any allergies to medications, foods or other products. Prior to vaccination, the patient was not diagnosed with COVID-19.Since the vaccination, the patient had tested for COVID-19 as well. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 13Mar2021 at 17:00, the patient experienced swollen and painful lymph nodes in left armpit.The patient did not received any treatment for the events reported.The patient underwent lab tests and procedures which included nasal swab test on 30Jan2021 and the test result was found to be negative. Outcome of the events were reported as recovering at this time of the report. No follow-up attempts are needed. No further information is expected. Follow Up (25May2021): The following information was updated reporter, VAERS Primary Reporter Addl Qualification updated to patient,Age/Units captured as 46 years per event's onset:13Mar2021. relevant medical history none, for both events: Treatment Received captured No Vit D, recoded as VITAMIN D 3, PRILOSEC recoded as PRILOSEC [OMEPRAZOLE] concomitant medication reported.

Doctors appointment on May 18th to address right arm swollen lymph node identified on May 13th. On May 19th I experience the lost of my sense of taste and after my doctor's visit, Steroids and NAC were prescribed. It is now June 7th and I have yet to regain my sense of taste.

blood clot in his leg; swelling in his leg; sore arm; his muscle aches; didn't dilute it and he's received 6 times over the amount; didn't dilute it and he's received 6 times over the amount; Diarrhea; real tired; his blood pressure was real high; breathing problems; This is a spontaneous report received via a Pfizer-sponsored program. A contactable consumer reported that a 46-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot number was not reported) via an unspecified route of administration on 20Apr2021 (at the age of 46-year-old) as 1st dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On 20Apr2021, patient experienced diarrhea, was real tired and his blood pressure was real high. It was also reported that the vaccine wasn't diluted and the patient received 6 times over the amount on 20Apr2021. On an unspecified date, patient had sore arm and his muscles ached. On Apr2021, patient had breathing problems and was treated with breathing treatments three times a day and was put on steriods and inhalers. On May2021, patient had a lab work that confirmed that he had a blood clot in his leg, which has worsened because he has some swelling in his leg, the same leg that they found the blood clot in. The patient was hospitalized for the event blood clot in his leg and was given blood thinners. The patient underwent lab tests and procedures which included CAT scan of head and lungs both with unknown results on May2021. Outcome of the events blood clot in his leg, swelling in his leg and breathing problems was not recovered while outcome of all other events was unknown. Information on the lot/batch number has been requested.

Swollen underarm/lymph node area; Eighteen hours after shot slightly swollen injection site; Extreme tiredness.; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6208) via an unspecified route of administration in the right arm on 16Mar2021 at 9.30AM (at the age of 46-years-old) as a single dose for COVID-19 immunisation. The patient medical history was not provided. Concomitant medications included Ativan (MANUFACTURER UNKNOWN) on unspecified date for unknown indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6200) via an unspecified route of administration in left arm on 23Feb2021 at 03.45PM for COVID-19 immunisation. The patient had not tested positive for COVID-19. The patient experienced extreme tiredness on 16Mar2021 at 03:30 PM, slightly swollen injection site and slightly swollen underarm on 17Mar2021 at 03:30 AM and extremely swollen underarm/lymph node area on 17Mar2021 at 07:30 PM. The patient had not received any treatment for the events. Clinical outcomes of the event extreme tiredness, swollen injection site and swollen underarm were recovering. No follow-up attempts are needed. No further information is expected.

Facial Numbness, partial swelling to nose, upper lip, cheeks ( Dr. Visit Tested for Herpes - Negative Possible Lupus)

Pt also had the TDap vaccine on 4/19/2021 Pt started to have abd pain on 4/22/2021. Pt pain became worse despite treatment and then started to have lower ext wkness and numbess and unable to walk. Pt also had loss of hearing Diagnosed with Guillain Barre syndrome while in the hospital by a neurologist

Left under arm pain; chest (pectoral) pain; Lymphadenothopy.; Developed rash on left side of spine between shoulder blades.; This is a spontaneous report received from a contactable consumer, the patient. A 46-years-old male patient received his second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL9264) via an unspecified route of administration in right arm on 10Mar2021 at 16:00 (at the age of 46 years old) hours as single dose, for COVID-19 immunisation. No known Medical history. The patient did not have any allergies to food, medications, or other products. The patient previously took of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL9262) via an unspecified route of administration in left arm on 10Feb2021 at 16:00 hours as single dose, for COVID-19 immunisation and the events were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. No Concomitant medication. The patient did not receive any other medications or vaccines within 4 weeks prior to the vaccination. On 11Mar2021 at 5:00 hours, the patient experienced Left under arm pain and chest (pectoral) pain, Lymphadenothopy. Developed rash on left side of spine between shoulder blades. It was a painful bumpy rash about the size of a silver dollar. The lymph node issues began within hours of second shot and had not improved in 2 weeks. The events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. The patient did not receive any treatment for events. The clinical outcome of events painful left arm, chest pain, lymphadenopathy and rash were not recovered at the time of this report. No follow-up attempts are needed. No further information is expected.

vertigo; large, painful swollen lymph node under right arm; nausea; headache, severe pain at injection site. No treatment, symptoms occurred over Fourth of July weekend and everyone is closed...

On Tuesday after receiving the shot I started developing a rash throughout my body especially near injection sire. The lymph node under my right armpit was swollen and tender. I let my doctor know and he suggested I take Tylenol for the pain. The Tylenol helped with the tenderness.

I had swelling in my right armpit lymph node and a mild rash that developed on the 4th day. I also developed Bell?s palsy in the right side of my face. I went to the ER where I was prescribed prednisone and valacyclovir. These medications both helped a little. On June 25th the rash got worse, and the doctor prescribed a steroid cream which has helped. The rash has gone away from under my arm, but my lymph node is still swollen. On June 25th the doctor also said my face was more symmetrical, but I still have weakness and pain on my jawline and lip area. The pain is like a nerve pain and still comes and goes but it is not as bad as it was initially.

At 36hrs the swollen of that same area(left armpit - lymph node area)increased a little bit and the pain ismild-moderate.; at 24hrs felt pain (pressure like) in thearmpit (same as shoot - left shoulder)- lymph node area; start to feel flu likesyndrome; at 24hrs felt little bit of fever; muscle ache; Mild pain right after shot and increased to moderate within 12hrs; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old male patient received second dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Lot number: ER2613) via an unspecified route of administration in the left arm on 27Mar2021 at 14:00 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies. Concomitant medications included ascorbic acid vitamin C (MANUFACTURER UNKNOWN), glocosamine (MANUFACTURER UNKNOWN) and condoitrin supplements (MANUFACTURER UNKNOWN) from unknown dates for unspecified indications. The patient previously received first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6204) via an unspecified route of administration in the right arm on 06Mar2021 at 16:00 as a single dose for COVID-19 immunisation. Prior to vaccination patient not diagnosed with covid-19. The patient had not tested for COVID-19 since having the vaccine. On 28Mar2021 at 08:00 the patient experienced mild pain right after shot and increased to moderate within 12hrs. At 24hrs, on 28Mar2021 at 14:00, the patient felt pain (pressure like) in the armpit (same as shoot - left shoulder) - lymph node area also felt a little bit of fever and muscle aches similar to when somebody start to feel flu like syndrome. That fever and muscle discomfort resolved within two hours. At 36hrs, on 29Mar2021, the swollen of that same area (left armpit - lymph node area) increased a little bit and the pain was mild-moderate. The patient received paracetamol (PANADOL) as a therapeutic measure for the event Pyrexia. The clinical outcome of the events pain, lymph node pain, influenza and lymphadenopathy were resolving and pyrexia and myalgia was resolved after 2hrs, at 16:00 on 28Mar2021 at the time of this report. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No follow-up attempts are needed. No further information is expected.

Bells Palsey in the left side of the face. Lasted approximately 2 weeks and still have numbness in my tongue. Prescribed prednisone 60mg for 7 days. Also experienced extremely swollen lymph nodes in my left neck for approximately 4 days.

46 Y male with a PMHx of HTN, HLD, DM, hypoT, stage II NLPHL with concomitant low grade B-cell lymphoma (dx 5/19/21) (5/2021, chemo scheduled later this month) presents with cough and SOB x6 days. 1) COVID Pneumonia, Acute hypoxemic Respiratory failure - Symptom onset on 7/15. COVID positive on 7/16. Pt was fully vaccinated on 4/1/21. Pt presented satting 88%. In the ED, he was put on 2L O2, solumedrol, remdesivir, and offer tocilizumab, which he refused at first. Pt took Tocilizumab at night. Pt now on 12L oxymizer. Offered tocilizumab again and increased methylprednisolone to Q6h. - 12L Oxymizer. Goal SpO2 >92%. Consider ICU evaluation if requiring >40LPM and 60% FiO2 for SpO2 >/= 90% - Self-proning as tolerated for O2 req >3L - Methylprednisolone 125mg IV Q6h for 5 days (7/21 - 7/25) and taper down - Remdesivir 200mg IV x1, followed by 100mg IV daily until clinical improvement or 5 days (7/21 - 7/25 ) - f/u daily LFTs. Hold Remdesivir if ALT >10xULN or CrCl<30 - CRP, D-dimer, LDH, ferritin elevated. Trend QOD - Lovenox 40mg SQ BID and hold for Plt <25k, Fibrinogen <100, active bleeding - Tocilizumab 600mg IV x2 - Tessalon for cough - Encourage IS - Isolyte 500cc x1

Swollen lymph nodes under right arm; This is a spontaneous report from a contactable healthcare professional, the patient. A 46-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0150) via an unspecified route of administration in the right arm on 30Mar2021 (at the age of 46-year-old) as a single dose for COVID-19 immunisation. Medical history included pre-diabetic. The patient had no allergies to medications, food, or other products. Concomitant medication included ibuprofen (ADVIL) since an unknown date for an unknown indication. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6208) via an unspecified route of administration in the right arm on 09Mar2021 at 17:00 (at the age of 46-year-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 COVID-19 vaccine. On 31Mar2021 at 22:30 the patient experienced swollen lymph nodes under the right arm. The adverse 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 under the right arm was not recovered at the time of this report. No follow-up attempts are needed. No further information is expected.

arm became swollen, alot of pain and as the days went by he couldn't go to work due to couldn't raise his arm and was in deep pain

fever; big lump under left armpit; swollen neck left armpit; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration in the arm left on 30Mar2021 at 18:30 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient did not have any allergies to food, medications, or other products. The patient previously the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration in the arm left on 09Mar2021 at 18:15 (at the age of 46-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. On 31Mar2021 at 13:00 the patient experienced fever, big lump under left armpit and swollen neck. The patient did not receive any treatment for the event. Events had not resulted in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events fever, big lump under left armpit and swollen neck left armpit was not recovered at the time of this report. No follow-up attempts are needed. No further information is expected.

PATIENT CALLED PHARMACY TO REPORT FACIAL SWELLING. WAS ADVISED TO TAKE A COUPLE BENADRYL AND GO TO THE EMERGENCY ROOM. HE WAS UPSET AND ACCUSED US OF MAKING HIM TAKE THE VACCINE AND CLAIMED THAT WE SHOULD BE ABLE TO FIX HIS ADVERSE REACTION WITHOUT HIM HAVING TO VISIT THE ER OR COME BACK TO THE PHARMACY. HE CLAIMED THAT HE TOOK 3 BENADRYL AND THAT HE WILL WAIT TO SEE HOW HE FEELS.

if a patient experienced an allergic reaction to the first dose is there anything prophylactically needing to be done when administering the second dose of the Covid vaccine; delayed hyper sensitive reaction; Angioedema; Urticarial rash; This is a spontaneous report from a contactable other hcp. A 47-years-old male patient received first dose of bnt162b2 (BNT162B2), unknown on 18Dec2020 (lot number: EK5730) at SINGLE DOSE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Caller is a Physician Assistant. Caller states that she is calling about the Covid Vaccine. She had a patient received his first dose of the vaccine on Friday 18Dec2020, 3 days later on 21Dec2020 he had an urticarial rash that persisted, The urticarial rash was treated with prednisone and resolved by 27Dec2020, it has not reoccurred. The allergist said it was a delayed hyper sensitive reaction that was Prompted by the immune simulation from the vaccine. The Patient was treated for the urticaria. Caller would like to know if a patient experienced an allergic reaction to the first dose is there anything prophylactically needing to be done when administering the second dose of the Covid vaccine? Caller is very upset and frustrated and stating she wants to speak to someone that is a clinician with the clinical trial team who can give her recommendations for a specific patient. Caller asks if they should do Prophylaxis with antihistamines for the second dose. He did not have anaphylaxis but he had angioedema. Caller states that she did a Vaers report on 22Dec2020, but no one contacted her. He started taking Zyrtec and Vistaril. The Allergist said it was fine and he will still need the 2nd Booster Dose. The Angioedema started on 22Dec2020, it was also treated with prednisone, in addition to being administered Benadryl IM, and Vistaril. The outcome of the event urticarial rash was recovered on 27Dec2020 and Angioedema was recovered on 22Dec2020. No follow-up attempts are needed; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the angioedema and the other reported events due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including serum tryptase level and complement panel, 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 developed left flank pain the day after receiving the vaccination. Workup for kidney stone was negative. Was seen by PCP on 1-11-21 and was given diagnosis of probable shingles due to type and nature of pain. No rash is present. Also lymphadenopathy of left axillary lymph nodes. Was prescribed medication for pain only.

Swollen under arm and a knot/upper part of shoulder and chest area was swollen.; Nauseated; Real dehydrated; Kidneys started hurting and felt like kidneys were overworking; Mouth dry; Kept having to go to the restroom; Kept using restroom and had to pee a lot; He is a little sore, but the pain is not as bad; Pain in kidneys woke him up from sleep.; Arm is still swollen but swelling went down; red spot under his arm that looks irritated; This is a spontaneous report from a contactable consumer (patient). A 47-year-old male patient received bnt162b2 via an unspecified route of administration in upper right arm on 02Jan2021 between 07:00-07:30 at single dose for covid-19 immunization. Medical history: None. There were no concomitant medications. The patient experienced swollen under arm and a knot/upper part of shoulder and chest area was swollen on 03Jan2021 18:00, nauseated, real dehydrated, kidneys started hurting and felt like kidneys were overworking, mouth dry, kept having to go to the restroom; kept using restroom and had to pee a lot, he is a little sore, but the pain is not as bad, pain in kidneys woke him up from sleep all on 03Jan2021. Got COVID Vaccine on Saturday. Was swollen up under arm. Over kidneys, started hurting. Swelling went down. Took Naproxen and Ibuprofen. Mouth was really dry. Felt like kidneys are overworking. Keeps drinking water and going to the restroom. Kidneys started hurting. Received through work. Employed at a mental health and mental retardation school. Arm swollen with a knot. Got off Sunday morning, 03Jan2021. By 18:00, under arm was swollen. Thought he slept wrong or he had an issue with an artery. Under arm and into upper part of shoulder and chest area was swollen. He was nauseated. Felt really dehydrated. Kidneys started hurting. Felt like kidneys were overworking. Felt similar to when he previously had a kidney infection. Knew something wasn't right. Kept using restroom and had to pee a lot. Kept drinking. Kidneys were hurting from 03Jan2021 to yesterday. He is a little sore, but the pain is not as bad. Was drinking water, cranberry juice, and orange juice to flush the COVID vaccine through. Pain in kidneys woke him up from sleep. Is a little swollen. Pain is better than what it was. Between 02:00-03:00 it was done. Swelling was really bad. Start taking Naproxen and Ibuprofen. He was hurting too. Arm is still swollen but swelling went down. There is a red spot under his arm that looks irritated. Supposed to receive second COVID Vaccine on 30Jan2021 but was not going to take it. Clarified he took Naproxen with Ibuprofen in it for the anti-inflammatory. Confirmed he was only referring to one product. Naproxen was just bought from the store. Unable to provide NDC/Lot/Exp because he does not have product at time of call. Formulation: 200mg per pill, took two pills then six hours later took another two for Voluntary; high number of COVID Cases at his work. Scared to take second COVID Vaccine. The patient underwent lab tests and procedures which included Covid Test: unknown results on an unspecified date (He has to take COVID tests twice a week). The outcome of events was unknown. Vaccination Facility Type: which is a mental health and mental retardation school. He has to take COVID tests twice a week. No additional vaccines administered on same date of Pfizer suspect. The event was not required a visit to doctor or other healthcare professional office/clinic or Emergency room/department or urgent care. Prior vaccinations within 4 weeks was none. Adverse event follow prior vaccinations was none. Relevant tests: none. Information about Lot/Batch number has been requested.

2 days after vaccine, left neck spasms and pain. Now developed sternoclavicular synovitis on the left side

R axillary tenderness/lymphadenopathy persisting, now 2 weeks post vaccination; R axillary tenderness/lymphadenopathy persisting, now 2 weeks post vaccination; This is a spontaneous report from a contactable Physician (patient). A 47-years-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in the right arm on 28Dec2020 12:00 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced r axillary tenderness/lymphadenopathy persisting, now 2 weeks post vaccination on 29Dec2020 with outcome of recovering. The patient was not treated due to the events. The patient underwent nasal swab covid test on 04Jan2021 and was negative. The patient did not experienced covid prior to vaccination. Information on the lot/batch number has been requested.

Tennis ball size swelling of lymph notes in Right armpit. Discovered 36 hours after shot. Only other symptom is pain in right arm that required OTC ibuprofen.

Pfizer-BioNTech Covid 19 Vaccine Description 1.26.2021: It first started with swelling hands then tingling in bilateral fingers and hands. That progressed to tingling in feet and toes. The nerves coming into my arm pits were very painful and I couldn't put my arms against my body. Petechia rash on my torso. Numb left lower lip and jaw area, numb right shoulder, numb shins and calfs. when the numb lip began my PCP had me go to the ED for evaluation. All blood work and Electrolytes came back normal. All this lasted over a week and the petechia spots are still on my torso, but seem to be going away.

Starting ~14hrs after injection: moderate headache, full body ache, fatigue, mild swollen neck lymph nodes

Extreme rash all over body. Very red, very itchy. Hands and eyes very swollen. Alternating Benedryl and Claritin to lessen itch and swelling.

onset of dizziness and fatigue 24 hours after vaccine (1/30/2021). 48 hours after vaccine (1/31/2021), developed cough and low grade fever. Symptoms continued to progress with continued cough, fatigue, and generalized weakness with shortness of breath. Had O2 sat of 88% with activity on 2/9/2021 and went to emergency department and was diagnosed with pneumonia. Treatment started for community acquired pneumonia with Amoxicillin and Azithromycin. Patient discharge home from emergency department

Lymphadenopathy on left neck. 800 mgs ibuprophen improved yesterday, today second lymph node inflammation.

Pfizer COVID-19 Vaccine EUA Pt received 1st dose of vaccine 1/9/21 with no initial adverse events. By the end of the day, he developed pain at the injection site, could not move arm, could not lie on left side, could not sleep. Felt pain was at injection site, not joint. Sunday morning patient took naproxen and pain subsided for a while but came back. Swelling went down a bit. On Monday, 1/11/21 pain came back, but pt was able to work through it. Pain was much better than Saturday. On Tuesday, the pain and redness was gone, but pt did still not feel 100%.

I had adverse event to both vaccines, The second was and second dose EL 8982 Both times I had a slight fever. Painful enlarged lymph node in left armpit. Body aches that kept me up at night. And feeling mentally cloudy. Symptoms lasted for 203 days. I called my oncologist on the phone.

Soreness at point of injection, beginning a few hours after shot. Greater swelling/discomfort at approximately 4AM the next morning. Mild fatigue, slight headache, mild swelling at lymph nodes approximately 20 hours after dose.

Swollen face, tongue feels fat, headache behind R ear, facial dropping, slurring words, eye doesn't close all the way. Started Sunday night to the morning went to ER. Did blood test for Lymes. Diagnosed with Right sided BELLS PALSY Gave prednisone and Valtrex in ER and discharged on those meds too.

47 year old Gynecologist with PMH of severe MDD, GERD, asthma, referred to the ED by his PCP, after 5 days of gait instability, and about 4 weeks of altered mental status, confusion, short term memory deficits and malaise. ADEM suspected and extensive infectious, inflammatory and neoplastic workup was initiated. CT brain - reported NAD MRI brain consistent with Acute Diffused Encephalomyelitis and suspected ADEM. MRI cervical spine with evidence of demyelination involving posterior cord. ICU course complicated by new onset of aphasia, partial left frontotemporal seizures, LGIB due to proximal rectal laceration and central diabetes insipidus. Admitted 3/15/21. On 3/17 he developed aphasia with right sided facial droop and stroke alert was called. Later on 3/17 he developed GI bleeding and was taken for emergent colonoscopy, from which no significant conclusions could be made due to lack of preparation and subsequent poor visualization. No foreign body was reported. After he continued to have ongoing bleeding, the patient had a sigmoidoscopy, during which the migrated clip could be removed and two new hemostatic clips were placed. He subsequently developed large volume urine output and nephrology was consulted; the patient was diagnosed with likely diabetes insipidus. On 3/20 acyclovir was discontinued after HSV PCR was negative. High dose solumedrol for ADEM completed 5 day course 3/21. VDRL was non reactive. There were no oligoclonal bands. Solumedrol 1g daily was started 3/24/21: MRI showed L>R patchy enhancement and diffusion abnormalities consistent with ADEM. Repeat MRI showed new restricted diffusion of the left superior cortex, bilateral medial temporal lobes and hippocampi, genu of the corpus collosum, and pericallosal white matter, with ddx including status epilepticus, autoimmune encephalitis and infectious encephalitis including herpes simplex. Completed 5 day course of high dose steroids, 6 days of IVIG and on ongoing PLEX. Neurological improvement noted 3/25

Swollen lymph nodes Migraine headaches Burning in back of left thigh continuously Numbness in left foot

tinnitus: high-frequency hissing/ringing non-stopping, volume - low, more on right ear. wakes me up at night. learned to train my brain to ignore. two weeks after the 1st vaccine shot, hearing another high-frequency ringing on right ear, louder, on and off, needing more effort to handle. other reactions: right after the 1st shot, felt face swelling. these symptoms disappeared 4 hours later. left arm sore for rest of the day, back to normal next day.

Huge lump on right underarm. Used pain medication and cold/hot compress for the pain and sensitivity. Fully recovered after one week.

facial swelling. lower lip and left check swelling. Woke as result of swelling at 4am. took 2 oral benadryl and swelling appeared to stop growing. went back to sleep and woke at 7am with swelling still at same level. started to subside at 10am and by 5pm (the time of this submission) had almost fully subsided.

Mild tingling in the right foot, tachycardia during the first 15 minutes after getting vaccinated. Severe pain and swelling of the left shoulder, tachycardia or change in heart rate, mild swelling of the hands, mild headache, weakness and tiredness for 48 hours after the first 5 hours of getting the vaccine.

tongue and jaw swelling, numbness post vaccination similar to first vaccine. BP 132/99, o2 98%. Given zyrtec PO, symptoms improved. Doctor and EMT on site and released to go home.

Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Allergic: Itch Generalized-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash Generalized-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Abdominal Pain-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Headache-Medium, Systemic: Visual Changes/Disturbances-Medium, Additional Details: complained of heart burn and blood pressure rose

Skin rash on my right arm (I was injected on my left arm). Also hives from the rash in my ear canal. Itchy and swollen but not painful.

Lower left leg pain, swelling and redness 3 days after 2nd dose of Pfizer Covid vaccine. Ultrasound confirmed superficial blood clot from ankle to knee.

My husband's face swelled up. The right side of his face around his nose including his lips. It happened suddenly with no warning. He had been feeling ok but that morning experienced sudden onset of severe pain in his hip. He had taken ibuprofen for the pain a few hours before the swelling in his face happened. He has never had any reactions to ibuprofen. He has no known allergies. Nothing like this has ever happened to him before. The swelling got worse overnight but during the following day the swelling started to go down. By that night it had gone down completely. Now he is fine but his lips look a little bruised, However, now we don't know if he should get the second vaccination which is scheduled on the 30th April. We did not contact a Dr.

Swelling under left arm with some tenderness, chills headache, fatigue. Patient had COVID 6 weeks prior to this presentation. Patient given normal saline IV fluids. Clinical impression is cellulitis. Patient is discharged home from ER and given a prescription for cephalexin

Severe, Acute Inflammatory Demyelinating Polyneuropathy (Guillain-Barré syndrome), with no other antecedent upper respiratory illness or GI illness. First developed extremity paresthesias, followed by rapid onset and progression proximal > distal, upper >lower extremity weakness on 4/6/2021, reaching peak on 2nd day of IVIG (4/13) initially with subtle improvements on his 3rd dose of IVIG (4/14; received total 2g/kg over 5 days) and then rapid worsening since 4/21/2021 to quadriplegia and bulbar weakness, requiring intubation on 4/26. Now on plasmapheresis and still hospitalized.

Approximately two weeks after receiving the vaccine I developed Shingles. My symptoms started as a sore/tender area in the center of my right collarbone and a red bump behind and slightly above my right ear that spread until the right side of my neck and head were covered in a thick set of rashes. It took about five days for the rash to fully develop. I do not have an autoimmune disorder or any other medical condition that would lower my immunity. I have not been under any undue stress nor am I recovering from a recent illness. I am also not immuno-compromised in any way that I am aware. I had a physical in February with no issues identified. I did have chicken pox as a kid.

Pt describes feeling unwell that night, nausea and vomiting next day, general body aches, hypothermic, 3 days later seen in ED, hypotension, septic shock, and DKA/AKI. Also noted to have mild prominence of right oropharyngeal well with normal epiglottis and larynx on CT. There is noted uvular edema of unknown etiology

Slight headache; Right arm was sore where shot was; Little tiredness; Arm swelling after first dose; This is a spontaneous report from a contactable consumer (patient). A 47-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 17Mar2021 10:15 (Batch/Lot Number: EN6198) at the age of 47-years-old as single dose for covid-19 immunization (reported as 'protection for self and others'). Medical history included ongoing Fibroneuropathy, he had it in his feet, started after low back surgery 30 years before in 1991, L5 fractured, had 2 rods and 4 screws into low back, ongoing tremors both arms and hands, mainly left started in high school when first he first noticed, ongoing high blood pressure started in early 2000s, ongoing high cholesterol started in early 2000s, and patient had been on social security disability since 2014 and ongoing. The patient's concomitant medications were not reported. The patient experienced slight headache, right arm was sore where shot was, little tiredness, arm swelling after first dose on 17Mar2021. The outcome of the event headache was recovered on 17Mar2021 with duration of 15 minutes, the outcome of the other events was recovered on 19Mar2021. No follow-up attempts are needed. No further information is expected.

2nd dose lot: 4/21/2021 He reports that after his initial vaccination he developed significant skin rash incorporating mostly the trunk and collar region. He reports this was significantly itchy however tolerable at that time. After his booster he had a significant flare of his skin reaction including severe dermatitis, severe urticaria, severe swelling involving the trunk neck and face which prompted him to be seen in the ER where he was given parenteral steroids as well as oral steroids.

Within 15 minutes began feeling itching on head and neck, told the nurse who checked with me before leaving and they said I could take Benadryl. 45 minutes later experienced painful burning and swollen welts on small of my back in several spots. Largest spot was about 6 inches wide and 3 inches tall, felt warm and rigid and itched after burning sensation ebbed (about an hour). Took Benadryl but didn't seem to change the swelling or itching. Now three days later it is reduced to one spot about an inch in diameter, no longer taking the Benadryl.

Light headed, dizzy night of shot. Went to bed. 400 am fever and shivers for 5 hours. Massive headache. Lymph nodes and testicles swelled. All pounded to my heart beat. Kept taking Tylenol and didn?t seem to matter. Last for 5-6 hours. Massive headache continued...tired but hard to sleep sleep and in zombie like state. Woke up Friday feeling a little better. Went downhill about 5pm Friday. Headache returned. Tired and couldn?t sleep much. Brain in fog. Went to bed. Woke up with headache on Saturday. A wave of fatigue came over Saturday around 3pm. Tried to nap but couldn?t sleep. Persistent dry cough developed Saturday night. Lasted through Sunday. This is all to the best of my recollection.

"Pfizer-BioNTech COVID-19 Vaccine EUA" Received vaccine Thursday evening, Friday evening noticed tightness in right side of face. Saturday morning woke up with right side of face very swollen. Did a video dr appt they advised to visit the ER, ER prescribed antibiotics. Facial swelling has continued to get worse and I have scheduled an appointment with my primary dr today. NO other symptoms just very swollen right side of face with no relief.

pericarditis diagnosed in setting of positional chest pain, minimal EKG changes, trop negative, + leukocytosis

PATIENT HAD A GOLF BALL SIZE LUMP UNDER HIS RIGHT ARMPIT THE NEXT DAY FOLLOWING THE VACCINE, SOUGHT TREATMENT FROM HIS DR 06/02/2021, PATIENT SAID DR PRESCRIBED ANTIBIOTIC AND ULTRASOUND TEST-OUTCOME UNKWON AT THIS TIME.

Patient presented to the ED and was subsequently hospitalized within 6 weeks of receiving COVID vaccination. Diagnosis was severe sepsis with septic shock.

Swollen lymph node under collarbone on left side; This is a spontaneous report from a contactable consumer (patient). A 47-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in arm left on 03Mar2021 at 10:15 (Batch/Lot Number: EL3247) (at the age of 47-years-old) as 1st dose, single dose for COVID-19 immunisation. Medical history included hypertension. Concomitant medication included amlodipine besylate taken for an unspecified indication, start and stop date were not reported. The patient experienced swollen lymph node under collarbone on left side on 07Mar2021 (also reported appeared 4 days post vaccination) and continues through day 7. The patient did not received any treatment for the event. The patient did not have Covid prior to vaccination and had not tested for Covid post vaccination. Outcome of event was recovering. No follow-up attempts are possible. No further information is expected.

tendon inflammation; red dots all over my legs; I could not just walk; on my left leg down I have a bump and it's painful; on my left leg down I have a bump and it's painful; This is a spontaneous report from a contactable consumer or other non hcp. A 47-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 14May2021 (at the age of 47 years old) as 1st dose, single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. No relevant medical history. The patient reported that he got first dose of PFIZER-BIONTECH COVID-19 VACCINE on 14May2021 and was scheduled to get his second dose on 04Jun2021. The patient looking for guidance if he should get a second dose today as he experienced adverse reactions after first dose. On 30May2021, when he woke up in the morning he could not just walk, stated never happened before. His right thigh, right leg completely painful, he got crutches and started to walk. On 31May2021, he went to emergency room, where they did an X- ray and blood tests for blood clots but they did not see any blood clots. They gave him some gel and some muscle relaxants and told him that maybe he had tendon inflammation, but he did not run or he did not even exercise. Now after 4-5 days (Jun2021), cannot walk and now he started walking a little bit, but pain was still there. His thigh was swollen, and he had red dots all over his legs and on his left leg down he had a bump, and it was painful. He also had this red and red dots everywhere. The patient underwent lab tests and procedures which included X- ray and blood tests: did not see any blood clots on 31May2021. The outcome of the events red dots all over my leg, tendon inflammation was unknown, i could not just walk was recovering, on my left leg down i have a bump and it's painful was not recovered.

difficulty walking; headache; chills; aching of bones; tiredness and weakness; tiredness and weakness; loss of weight; loss of appetite; my joints got pain; it's the pain at the injection site; Muscle pain; Fever; Nausea; Feeling unwell; Restless; congestion; dizzy; swollen; constantly using the bathroom, having bowel movements; peeing a lot; can't stand up; I can't get out of the bed; my legs are so weak; I can't even stand now; This is a spontaneous report from a contactable consumer (patient). A 47-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0191), via intramuscular route of administration in right arm on 01Jun2021 at 01:00PM as single dose for covid-19 immunisation. The patients medical history included large prostate, gold stones in 2014, high blood pressure, operation on Gall Bladder (gall stones that were in gall bladder in 2014). Concomitant medication included lisinopril (20 mg, 1xday) for blood pressure measurement. Patient had the Pfizer covid vaccine on 01Jun2021. Patient went to get the Moderna but he got the Pfizer. Nurse told him that everybody was different, and it work in different kind of ways and she said that once he got the vaccination to fight the COVID, it just maintains that. On 03jan2021, Patient did not get out of the bed, he became dizzy, weak, his legs were so weak, lost massive weight (dropped to 145kg/2 pound) and the pain at the injection site, feeling tired, had a headache, got muscle pain, had the chills, joints got pain, bone aches. He had a fever, nausea, congestion, feeling unwell, swollen, was restless and pain to walk. He did not stand up. Took tylenol (spoonful, once a day, orally) for the headache and the fever. Had also been using the bathroom a lot. his most recent weight was 135 after he took the shot at 1:00pm on 01Jun2021. On 22Jun2021 to patient has get the second one but did not feel like taking it. Patient did not had any prior vaccinations within 4 weeks. The outcome of the event cannot stand was unknown and other event was not recovered. Information on Lot/Batch number was available. Additional information has been requested.

tingling in his right pinky/tingling in certain parts of my legs saying "it'll flash then stop/Tingling in my fingers; My arm felt stiff; A loss of sensation stating "I really haven't had any sense of sharp pain; He states that the sensation is more warm or burning; that it was a "swelling/numbing effect".Swell little bit; I could feel things were swelling; He reports that immediately after he received the dose (in his right arm) he "could feel it throughout my body" and that it was a "swelling/numbing effect".; This is a spontaneous report from a contactable consumer or other non hcp (Patient). A 47-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection,Batch/Lot Number: ER8735), via an unspecified route of administration, administered in Arm Right on 12May2021 (Age at time of vaccination 47-years-old) as 1ST DOSE, SINGLE DOSE for covid-19 immunization. The patient medical history was not reported. Patient stated that I took the Ibuprofen because when I first got the shot I could feel things were swelling (further details unknown), I could feel some like, I took pills at the time like a it was swelling like some pain initially and then I heard from other that to prevent the headaches and to prevent the soreness of the arm, to took Ibuprofen, so that I took it as a preventive measure that, I would not get sore but I didn't have any of those, my arm felt stiff but I never felt the pain, and I never feel any headache at the time, like I said, I kind of lost sense of acuteness, loratadine taken for hypersensitivity, start and stop date were not reported. Patient reports that immediately after he received the dose (12May2021) (in his right arm) he "could feel it throughout my body" and that it was a "swelling/numbing effect". He has since been experiencing neurologic symptoms that include: tingling in his right pinky, a loss of sensation stating "I really haven't had any sense of sharp pain. I can feel pressure but can't determine actual point of pressure." He also reports "tingling down [his] left arm while laying down last night" and tingling in certain parts of my legs saying "it'll flash then stop" and is most notable in the calf/shin of his right leg. He states that the sensation is more warm or burning, "not sharp pain" and that it will be a "small burst in a certain area, then go away". On an unknown date Patient also experienced that ,I kind of noticed that I can't feel thing I will say go numb as if kind of feeling through my body,Swell little bit; I could feel things were swelling,I don't have like feeling like touch like when I touch something I feel pressure but I don't have that huge sense of feeling,Tingling in my fingers, its practically I lost my left arm The outcome of events was unknown. Information on the lot/ batch number has been requested.

At Midnight I was going to sleep, I was sweating profusely and could not feel my pulse. When I asked my wife to call 911, I went into the bathroom to change into clothes to get ready to go. I do not remember going to get dressed, I passed out and 911 had arrived and they believed I was in cardiac arrest. I went to the ER, there was a right artery blockage and put in a stint. They also found out I had 8 facial facial fractures due to the fall I had. I was all swelled up in my face so in May I went back for surgery on my face to fix the multiple facial fractures. And now I am back to normal, except I am on blood thinners. The DR could not find anything wrong after follow up, so no one knows why the cardiac happens.

I started feeling a numbing of my feet and lower legs (calves). On the morning of May 31s, I awoke to an excruciating painful calf cramp. In the past, whenever I've had these, they would fade in pain within one or two hours. The pain from this cramp lingered for several days. I soon noticed my feet afterwards becoming swollen and feeling even more numb and for entire days. On June 11, I couldn't fit my feet into my shoes. I put on some loose-fitting sneakers and took myself to the Emergency Room.

Swollen lymph nodes in neck, head, collar bone, shoulder and chest; This is a spontaneous report from a contactable consumer, the patient. A 47-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 18Apr2021 at 10:00(at the age of 47-years-old) as a single dose for COVID-19 immunisation. Medical history included seasonal allergies from an unknown date. Concomitant medication included rosuvastatin (MANUFACTURER UNKNOWN) for unknown indication from 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 COVID-19 vaccine. On 20Apr2021 at 17:00, the patient experienced swollen lymph nodes in neck, head, collar bone, shoulder and chest. Swollen lymph nodes in collar bone and shoulder persisted 11 days later. The event resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the event swollen lymph nodes in neck, head, collar bone, shoulder and chest were not resolved at the time of this report. No follow-up attempts are needed; information about lot number cannot be obtained.

Difficult to sleep; Both feet hurt; Feet were slightly swollen, but not discolored; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old male patient 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 24Apr2021 at 09:00 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. Medical history was reported as none. The patient previously did not receive any medications. Concomitant medications included simvastatin (STATIN) taken for an unknown indication from 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 24Apr2021, Saturday morning, the patient received the shot. On 26Apr2021, Monday night, the patient noticed both his feet hurt. The patient's pain increased on Tuesday and Wednesday (28Apr2021) making it difficult to sleep on Wednesday. On Thursday and Friday, they hurt less but the patient still experienced a little hurt. The patient never had foot pain for any reason in the past, except after a long hike or other extreme exertion. The patient did not do anything unusual to make his feet hurt. On an unknown date in Apr2021, the patient's feet were slightly swollen, but not discolored and they were not sore to the touch. The clinical outcome of the events both feet hurt, making it difficult to sleep and feet were slightly swollen, but not discolored was recovering at the time of this report. No follow-up attempts are needed. No further information is expected.

Morning of 4/6 (4 days after shot), woke to sore throat; Swollen lymph nodes; Joint/muscle aches; Joint/muscle aches; Slight dizziness; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the left arm on 02Apr2021 at 14:30 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. Medical history was reported as none. The patient did not receive any other medicines within two weeks prior to the COVID-19 vaccine. Allergies to medications, food or other products were reported as none. 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 COVID-19 vaccine. On 06Apr2021, at 05:00 in the morning 4 days after the shot the patient woke up with sore throat, swollen lymph nodes, joint/muscle aches, and slight dizziness. The patient had no fever. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of events. The clinical outcome of the events sore throat, swollen lymph nodes, joint aches, muscle aches and dizziness was recovering at the time of this report. No follow-up attempts are needed. No further information is expected.

all joints hurt, right arm swollen from elbow down to fingers, tingle sensation in lower right arm and fingers

Within 10 minutes felt a rush of heat down right arm and tingling in fingers. Then I felt it in the left arm, however the left arm stopped tingling within 24 hours, but my right arm still has the tingling , feels bloated in my hand and my arm feels restless.

swollen lymph nodes under left clavicle; tiredness; pain at the site; This is a spontaneous report from a contactable consumer (patient). A 48-year-old male patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Solution for injection, lot number: EK9231) via an unspecified route of administration on his left arm on 28Dec2020 at a single dose for COVID-19 immunization. The patient had no medical history and no relevant family medical history. There were no concomitant medications. The patient worked at 12-13 different hospitals and around first responders and COVID positive patients. The patient got the first dose of the Pfizer BioNTech COVID vaccine on 28Dec and he has developed adverse events as of 'yesterday'. Reported he was tired and having swollen lymph nodes under the left clavicle, no fever or other symptoms. The patient noticed the swollen lymph nodes on 06Jan2021 when coming out of the shower. Since he worked in the hospital he asked a few Physicians about it. Mentioned he did do something with the (Public health agency name) and signed up and they sent him text messages every day to see how he was feeling the first 7-8 days. He never had symptoms that day except for pain at the site and a little tiredness post day (29Dec2020) of getting vaccine and then nothing after that. The Physicians he spoke to were only to palpate the one lymph node, it was pretty visible. He had none visible or palpated in the neck and they couldn't feel anymore there or anywhere else. He has had some tiredness today also, but no fever or anything else. He did not receive any other vaccines the same day or 4 weeks prior. Has not had any problems with previous vaccines. He was to go back for the second vaccine scheduled on 15Jan, but not sure if he should hold off. He worked with medical Devices, pacemakers, defibrillators, pacemaker devices. He does not take any medications and has not had any bloodwork. Patient was asking what should he do if he still has the swollen lymph nodes when he is due to get the second vaccine. The patient had no relevant tests done. Outcome of the events swollen lymph nodes and tiredness was not recovered, while unknown for the other event.

1/8/21, 1600: Received second dose of COVID-19 vaccine 1/9/21, 1800: Began to feel feverish and achy, and later identified some pruritic lesions beginning to emerge 1/10/21: Developed a crop of raised red pruritic lesions on distal extremities; later noticed visible swelling of the face. Patient did not experience swelling of tongue or respiratory compromise. Patient self-administered Benadryl and a Medrol Dosepak. The lesions expanded to involve torso. 1/11/21: Symptoms subsided, though there was a sensation of recrudescent pruritis at unspecified time. 1/11/21, 1631: Labs ordered; patient CBC and CMP were WNL. Noted that platelets were normal, no eosinophilia, and LFTs were WNL. Positive COVID-19 antibody test. The patient stated he had COVID-19 in November, but no positive test is noted in the patient chart.

On 1/23/21 at approximately 3:30pm I began to develop headaches. Approximately 2-3 hours later I began to feel nauseous and began to vomit. I then was taken to the Emergency Room where I had begun to suffer from an Addisonian Crisis where I was given Stress Dose steroids. The stress does steroids where given through 1/24/21 and medicine for the headaches are still be used to relieve the pain from the headaches. I was released from the hospital the late morning in the late morning of 1/25/21

Peri-oral Angioedema: Mild but obvious angioedema of left lower lip started around 30 hours post-injection on 1/29/21, which subsided overnight and migrated to involve predominantly the right lower lip the following day (1/30/21), which similarly subsided spontaneously over a few hours, followed with very mild (noticeable to patient but less obvious to others) angioedema of the upper lip appearing on morning of 1/31/21, fully resolved by around noon that day and has not recurred.

Hands and feet turned pale blue and were numb to touch 3 days after vaccine. Hands and feet swelled 5 days after vaccine and alternate between normal and swollen (cannot wear rings). Day 7 noticed nerve tingling sensations at random sites (arms, legs, back, hips). Random 'pop-up' welts that subside after 20-30 minutes. Tingling and random swelling inside lips.

bakers cyst behind my right Knee; pain and swelling in my right knee/ calf and ankle/in the right leg/in left hand; pain and swelling in my right knee/ calf and ankle/in the right leg/in left hand; pain and swelling in my right knee/ calf and ankle/in the right leg/in left hand; pain and swelling in my right knee/ calf and ankle/in the right leg/in left hand; This is a spontaneous report from a contactable consumer (patient). A 48-years-old male patient received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 Vaccine, lot number EH9899, via an unspecified route of administration in left arm on 06Jan2021 at 09:00 at single dose for COVID-19 immunization. The patient received vaccination in Doctor's office/urgent care. Medical history included bladder cancer from an unknown date, cancer treatment with tumor vaccine therapy BCG (Bacillus Calmette Guerin) on 23Dec2020, bone spur in right thumb from an unknown date, COVID-19 from an unknown date and drug allergy to amoxicillin/clavulanate potassium (AUGMENTIN). The patient has not been tested for COVID-19 since the vaccination. Concomitant medication included doxycycline. On 08Jan2021 (also reported 3 days after the vaccine) at 05:45 the patient experienced pain and swelling in his right knee/calf and ankle. Pain and swelling in the right knee, calf and ankle continued until 14Jan2021 when the patient went to the urgent care. He was sent to the emergency room with a suspected blood clot and ultrasound proved no clot was in the leg. On 15Jan2021 the patient went to a hematologist and had an additional ultrasound which found a bakers cyst behind his right knee. He continued to have pain and swelling in the right leg and left hand which had already arthritis and he suspected it was an immune response to the vaccine. Rest, ice, compression and elevation were suggested as therapeutic measures to treat the events. The reported events had not resolved yet at the time of the report.

Headache, vertigo, body aches, fever, axillary swelling and pain for 3-4 days immediately following the administration. Headaches and vertigo continued and became sustained leading to an MRI to be done on 2/1/21 resulting in a neurology consult and high doses of prednisone for short term treatment of symptoms. Further lab work revealed elevated ANA levels. Now awaiting a rheumatology consult. Although moderately improved, vertigo and disorientation remains, unable to work.

Swelling under left armpit. Believe swollen lymph node. Sore for about 3 days. Today is one week after vaccine, swelling is still present but no longer hurts.

swelling in left hand, first knuckles of index, middle and ring fingers also swelling in right index finger pain when making a fist in left hand itching in both hands especially between fingers duration: 36 hours before swelling started to subside took one Loratadine 3/9/21 7pm

Directly after the injection there was a tightening of my throat. It did not affect breathing and dissipated over the course of the day. I also had experienced reactive lymphadenopathy, specifically in the left clavicle area. The lymph node protrusion was large enough to been seen with t he naked eye.

Pt presents to ED 2 days after covid vaccine with body aches, low grade fever, fatigue. Also with mild swelling on anterior lower neck. CT scan showed non-specific mild swelling, no sign of infection. Sent home with steroids.

Vomiting. 24hrs Diarrhea 30 hrs Headache Muscle Ache Chills Hives (severe) Nausea Stomach pain Anaphylaxis

Chills, fever, severe body aches, exhaustion and severe axillary lymph node swelling in left armpit. 5 days

Swollen/painful left arm, tingling in left finger tips, fever, chills, pain in left collar bone, random abdominal pains, muscle aches

DURING VACCINE, PATIENT FELT A SHARP TINGLING/SHOOTING PAIN DOWN HIS ARM. PAIN WENT AWAY, BUT HE WAS AWOKEN FROM SLEEP THAT NIGHT FROM THE PAIN. ARM WAS SORE AGAIN IN THE MORNING BUT THAT EVENING FELT AS THOUGH IT WAS SHOOTING AGAIN. PATIENTS WRIST STILL HAS TEMPERATURE SENSITIVITY AND CONSTANT NERVE PAIN, AND PATIENTS ARM IS SWOLLEN TO THE ELBOW.

Swollen lymph nodes under left armpit were severely inflamed when I woke up on Saturday 2/06/2021. 1-2 days later I had severe pain on my Left back- ended up being my brachial plexus nerve. Few days after that I developed numbness and weakness on my left side and pins and needles in my Left index finger. I saw my primary care doctor twice that week. He started me on low dose Prednisone and gabapentin for the pain while sleeping. When the nerve pain/numbness did not subside, I asked for a neurology referral. Two doctors saw me for brachial plexus neuritis. I have had 2 ultrasound guided and one fluoro guided cortisone shots along the nerve. I have also been going to PT 2-3 x/week to regain my strength on the Left side & calm nerve.

Swollen Lymph Node in the left armpit. It felt like a water balloon inside my armpit. I noticed it in the shower on the morning of Saturday, April 10th, 3 days after my second vaccine dose. There is no pain. But it did shift on Sunday and the swelling seemed to be both in my armpit and my left breast. But the swelling was reduced.

1). Fever (100.1) 2). Body ache 3). Lower left Leg moderate pain 4). Right under Arm pit swelling and moderate pain

5 days: Fever, chills, sweats, headache, muscle ache, dizziness, nausea, all-over body rash, all-over body swelling, loss of appetite No injection site problems

Patient presented to ER with left leg swelling, diagnosed with extensive Left leg DVT and extensive bilateral pulmonary emboli

Foot and ankle swelling 4 days after 1st injection, which is ongoing. Visit to vein doctor on 4/15 and diagnosed with blood clot in left ankle. Put on blood thinners and told to wear compression socks.

Leg weakness and numbness, bladder dysfunction. Diagnosed with Gullian Barre after hospitalization 3/17/21.

Shingles. Started with sore throat and headache. Pain intensified on left side only of back of head and throat/neck. Head swollen. Low fever developed. Went to urgent care twice over the weekend. Rules out strept and mono at first visit. Ruled out Covid at 2nd visit. Finally went to Emergency Rrom at hospital and they diagnosed with shingles. Treated with Acyclovir.

Swollen lymph nodes. After about a week after the 2nd vaccine I developed pain in the joints in the back of my head. The pain is now persisting for over a week. No specific treatment except using Voltaren 2.32% gel.

Medical facility gave #2 Pfizer apr 30. today I see on video R arm from shoulder to wrist not quite twice normal size, symmetric swelling, I do not see the site. There is NO pain and ROM is normal shoulder.

48-year-old male healthy presented with increased shortness of breath. He mentioned he had COVID-19 vaccine first dose almost 3 weeks ago then symptoms started of having shortness of breath with swollen upper and lower extremity not improving since it started. One week after vaccine developed generalized swelling in hands and feet up to thighs with firey red rash now on arms and inner thighs, felt warm. No itching. Reports some shortness of breath and chest pain. Treated outpatient with lasix without improvement, therefore required hospitalization for generalized anasarca. CT- pulmonary edema. Urine Protien/Cr ratio 0.16 - nephrotic syndrome unlikely, B/L lower extremity duplex negative for DVT, 2D echo showing normal EF of 60%

Got slight pain in armpit and little swelling found next day of first shot. And that went of couple of days. Next day after second shot, got a lemon sized swelling and pain in under arm - armpit where the shot taken (left hand). Got slight fever but not bad. Still having armpit pain and swelling. But pain is reduced slightly

Fri. Apr. 23, 2021: Within 12 hours of vaccine administration, and in addition to injection site soreness and discomfort, began to notice tenderness above left clavicle, and could feel slight lump or swelling there. Sat. Apr. 24, 2021: -7am-8am. Lump on upper surface and tucked behind left clavicle more noticeable and tender, painful if pressed. Was often irritated and pressed on by seatbelt when driving. -8pm: Lump above and on clavicle a noticeably swollen, firm mass approximately 2cm across, painful to pressure or touch. Apparently a swollen lymph node. Injection site deltoid sore, like ?punch? to arm. From this point on I will not document that further, other than to say the soreness peaked the following day, and lessened to non-issue rapidly after. Sun. Apr. 25, 2021: -8am: Swollen lymph node above left clavicle swollen even more, 2-2.5cm across, constantly sore. Painful when touched or pressed. -12pm: Pain associated with swollen lymph node above left clavicle spread laterally to lateral end of clavicle, and slight swelling to discomfort below lateral end of clavicle, in hollow between pectoral and deltoid muscles. Remained through night. Mon. Apr. 26, 2021: -8am: Lymph node over left clavicle still enlarged and tender, painful to touch or pressure, but not quite as bad as previous day. Irritated by seatbelt when driving. -8pm: Lymph node over left clavicle reduced in size to around 1.5cm across, still firm to touch and painful when pressed. Tue. Apr. 27, 2021: -8am: Lymph node still swollen, about 1-1.5cm across, firm, and painful if pressed. -8pm: Lymph node approximately 1cm across, but still firm, and painful if pressed. Wed. Apr. 28, 2021: -8am: Lymph node above left clavicle remains approximately 1cm in size, firm to touch, but not painful, only some tenderness if pressed. -8pm: Same condition as earlier in day. Thurs. Apr. 29, 2021 through Fri. May 7, 2021: The lymph node above the left clavicle was pain free. It stayed the same size, around 1cm, and is still firm enough to feel and locate by touch. May 7 marked 2 weeks since vaccination dose 1. Please note, patient was diagnosed as Covid-19 positive on Dec. 27 or 28th, 2020, but had a nearly symptom-free run of the disease (slight and short-lived cough, some joint pain 1 day, no fever, no other symptoms).

Patient is a 48-year-old male with patient history significant for CAD, CHF, ICD, HTN, hyperlipidemia, and smoking who presented to the ED yesterday morning with 1 day history of chest pain. Patient described the CP as moderate aching in the substernal area that did not radiate. The pain was intermittent, with each episode lasting 1-2 minutes. The CP was associated with LUE numbness and SOB on exertion. The chest pain and LUE numbness have now resolved. Patient also reports a three week history of RUE swelling. The swelling gradually worsened and is now associated with pain and proximal RUE bruising. RUE pain is rated 5/10. In the ED, patient was found to have NSTEMI and small right lower lobe segmental pulmonary artery embolus. Venous Doppler was positive for occlusive thrombosis in the R subclavian, basilic, and cephalic veins. Patient was started on IV heparin. Patient is scheduled for cardiac cath today. Hematology is consulted regarding PE and RUE DVT. Patient denies personal or family history of blood clots or recent travel. Reports receiving COVID vaccine in LUE approximately three weeks ago. Also admits to being more sedentary recently due to being unemployed. Denies nausea, vomiting, bleeding, bowel changes, fever, or chills. Significant PE findings: RUE edema, firm and tender to palpation, ecchymosis on proximal RUE, distal sensation and active ROM intact

Swelling of right hand. Patient instructed to follow up with PCP if symptoms return/persist or worsen. Stable, released from vaccination site.

Strong shoulder pain started on Sat 4/17 in the early morning that woke me up. Went away by 10a after taking tylenol and having a coffee. Sun 4/18: pain again woke me up and was more severe. Had to get out of bed to move around as pain was pretty bad. Went to urgent care. Found nothing serious (not a heart attack or clots, etc). Referred me to go see my PCP if it did not resolve in a few days. Thu 4/22: went to PCP. Pain had subsided for the most part, but started having reduced range of motion when lifting arm straight forward...could not get past 90 degrees (straight out) without pain and a feeling of physical binding in the joint. Suspected bursitis. Prescribed a steroid pack and muscle relaxer. Sat: 4/24: my son noticed my shoulder blade sticking out when attempting to reach for a glass of water while seated. Decided to make appt with an orthopedic. Fri 4/30: went to orthopedic. Took xray. Found no physical damage, trauma, etc. Noticed winged scapula as reason for lack of range of motion. Prescribed physical therapy. Fir 5/14: still same lack of range of motion and no pain. Went to first PT appt. They took range of motion measurements and agreed I was limited. Tested for other pain or signs of trauma and found none. Prescribed a PT regimen. After my own research combined with symptoms, and no physical trauma as the source. My suspicion is Parsonage Turner Syndrome brought on by the vaccination.

Small painful subcutaneous bump on the bottom of my foot. Although small, it is interrupting my walking. I haven't ever had issues like this before leading me to think the cause may be related to the vaccine. I'm reporting this in case there is some sort of pattern that others may be reporting. I say it's a small chance that it's related to the vaccine, but I wanted to report it since it was so unusual for me. In item 21 below I am checking Dr. visit. Although I have not visited a doctor yet, it looks as if I may have to.

Swelling and pain to left arm from deltoid to fingertips; Swelling and pain to left arm from deltoid to fingertips; This is a spontaneous report from a contactable nurse (patient also). A 48-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number: EL3248) via Intramuscular route of administration, administered in left arm on 03Feb2021 at 08:45 AM as 1st dose single for covid-19 immunisation in hospital. The patient medical history included hypertension. The patient had allergies with eggs. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient not been tested for COVID-19. The patient's concomitant medications included lisinopril, HCTZ and fexofenadine (within 2 weeks). On 03Feb2021, 09:00 AM, the patient experienced swelling and pain to left arm from deltoid to fingertips. The patient did not receive treatment for the adverse event. At the time of this report events outcome was not recovered. Follow-up attempts are completed. No further information is expected.

One week after second shot (5/29/21) I developed fatigue and dull headache along with protruding golf ball size swelling on the left side of my neck. Symptoms continue into today 6/3/21. Tomorrow will be 2 weeks since the second shot.

This is a follow up to a previously filed report.... Conditions continue to worsen. Swollen gland in neck continues, I've begun having fevers (days 16-17 after second vaccine shot), loss of appetite, difficulty opening mouth because something is now going on on my right jaw/ear area. Also, I'm not developing small skin infections on both hands and those are being treated by a dermatologist with topical antibiotic.

Severe pain in right lower back; Severe pain in right lower back; traveled to lower right abdomen; It left a numb feeling behind; The caller thinks he has a rare case of shingles happening; Slight swelling on right side; This is a spontaneous report from a contactable consumer (patient). A 48-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 at the age of 48-year-old, via an unspecified route of administration, administered in left deltoid on 23Apr2021 (Lot Number: EW0171; Expiration Date: 31Aug2021) as 1st dose, single dose for COVID-19 immunisation. Medical history included chronic lymphocytic leukaemia from 2021 and ongoing (states he was diagnosed about 2 months ago) and had shingles once already when he was 20 years old. The patient's concomitant medications were not reported. The patient stated that he had the first dose of the vaccine on 23Apr2021. The patient experienced severe pain in his right lower back on 23Apr2021. He spent 24Apr2021, 25Apr2021, and 26Apr2021 at the hospital in the Emergency Room getting treated for severe pain in his right lower back. He states they ran all kinds of tests, but they could not figure out what was going on. States he was not admitted to the hospital during that time; he was treated for severe pain in his right lower back in the Emergency Room. The patient mentions that his wife also had the vaccine and she had a sore arm and some body soreness, but she wasn't sick or anything like that. He states he was still recovering from severe pain in his right lower back. The pain migrated from his back around to the lower right side of his abdomen on Apr2021. States that it left a numb feeling behind on Apr2021. The patient stated that after reading and after seeing 5 doctors; the patient told his oncologist that he thinks he has a rare case of shingles happening on Apr2021. He thinks it was the very rare kind where you don't have a rash appear. He had shingles once already when he was 20 years old. This time he thinks that was what it was again with no rash, just pain and discomfort. The severe pain in his right lower back was much better than it was. Says his skin looks normal. There was some slight swelling on his right side on Apr2021. The patient states that when it was time for his second dose of the vaccine, he hadn't recovered from the first dose. He did not go get his second dose; states his doctor agreed with that decision. Severe pain in right lower back, traveled to lower right abdomen resulted in emergency room and physician office visit. The patient underwent lab tests and procedures on Apr2021 which included CT scan (they were checking his lymphatic system), MRI and Ultrasound were done at the Emergency Room. The patient stated they found nothing on these tests. The outcome of the event low back pain was recovering and for the rest of the events was unknown.

Lymph nodes in my groining, armpits, chest and back of my head are swollen and painful. Has been going on since March 21

Swollen inner checks; Extreme arm pain; Fatigue; This is a spontaneous report from a contactable consumer (patient). A 48-year-old male patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number and expiration date not reported), via an unspecified route of administration on 11Mar2021 13:00 (at the age of 48-years-old) at 1st dose, single dose in the left arm for COVID-19 immunization. The patient's medical history and concomitant medications were reported as none. The patient has no allergies to medications, foods, or other products. On 11Mar2021 23:00, the patient experienced swollen inner cheeks, extreme arm pain, and fatigue. The patient did not receive any treatment for the events. It was reported that the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine, did not receive any other medications within 2 weeks of vaccination, has not been diagnosed with COVID-19 prior to vaccination, and has not been tested for COVID-19 since the vaccination. Outcome of all the events was reported as recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium

"Cold sore" shingles outbreak in the lip, relatively large several hours after receiving vaccine second dose; "Cold sore" shingles outbreak in the lip, relatively large several hours after receiving vaccine second dose; This is a spontaneous report from a contactable consumer (patient). A 48-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0170, Expiration date: unknown), via unspecified route, administered in left arm on 23Apr2021 09:00 AM (at the age of 48-year-old) as 2ND DOSE, SINGLE DOSE for COVID-19 immunization. Patient previously received the first dose of BNT162B2 on 31Mar2021at 09:00 am (batch/Lot no: ER8734) at left arm for covid 19 immunization. The patient medical history and concomitant medications were not reported. On 23Apr2021 at 18:00, after the vaccination, the patient experienced Cold sore- shingles outbreak in the lip, relatively large several hours after receiving vaccine second dose. Prior and since vaccination patient has not been tested or diagnosed for covid-19. No other vaccines received within 4 weeks to covid vaccine. No treatment received. The outcome of the events was recovering. No follow-up attempts possible. No further information expected.

He left the hospital, he was 211 pounds. Now he is 215 pounds; It may be water weight, may his sodium is high.; It may be water weight, may his sodium is high.; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 48-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection; Batch/Lot Number: EW0170), via an unspecified route of administration, administered in arm left on 30Apr2021 (at the age of 48-year-old) as single dose, for Covid-19 immunization. The patient's medical history and concomitant medications were none. The patient did not administer with additional vaccines on same date of the Pfizer suspect. The patient's historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection; Batch/Lot Number: EW0151), via an unspecified route of administration, administered in arm left on 09Apr2021 around 9:00 to 10:00 (at the age of 48-year-old) as single dose, for Covid-19 immunization and experienced Heart attack. The patient has no idea he had any heart conditions and his wife had gotten the covid vaccine, hence his wife let him know that he was getting it too. He was being pressured by his wife to get vaccine. After the second dose, the patient was starting to put weight back on. On an unspecified date in 2021, whenever he left the hospital, he was 211 pounds and now he was 215 pounds. It might be water weight, and might his sodium was high, but he was starting to increase in weight. The patient underwent lab tests and procedures which included blood sodium: high (increased) , weight: 211 (increased) and weight: 215 (increased) on an unspecified date in 2021.The outcome of the events was unknown. Information on the lot/ batch number has been requested.

Phase 1. Injury (6 APR) Pain during Injection (tip of needle) and immediate flinch/twitch in heart area. Racing heart, Intensity of beat, Severe tinnitus left ear only, adrenaline, Can?t sleep; Symptoms worst when I get into bed Phase 2. (10 APR) Urgent Care Visit: Chest very weak, each day gets worse; inflammation left side of body (chest, hand, face), felt like hole in heart, shortness of breath, numb hand, easy to excite, pain when lean forward; heart out of rhythm; Phase 3: (13 APR) Nighttime rushed by wife to ER due to symptoms of a heart attack couldn?t breathe, numb hands, shivering, heart going berserk, dizzy, aggressive, heart out of rhythm. Did EKG and diagnosed with Arrhythmia and Palpitations Phase 4: 14 APR Condition Stabilizes with bed rest; heart speed and intensity reduces slightly, heart still out of rhythm; ringing in left ear continues; noticed left hand, face, chest all swollen, out of breath walking to mailbox; can?t breathe deeply; Chest begins to bubble, gargle, fizzle when I lay down. Palpitations in throat, legs, need to drink a lot water; can?t sleep due to heart racing then sore and breast bone enlarged; chest tenses up often. Phase 5: Visit to Cardiologist (26 APR) He mentions potential Nerve damage with injection and prescribes Ultrasound. Days later I have second ?ER like? Scare and confirm in my mind this also nerve related. Phase 6: Mid May Start Recovery: Chest still tenses up doing emails, phone, late at work; easily excited; Each night total relaxation; start to feel nerves twitching like electric pulses in left chest; Feels like Electric Pulses/Pain from injection site to location of original twitch in heart area. Lean forward pain/discomfort; Still very weak chest muscles that get painful and sore easily Phase 7: Early June: Ultrasound at Heart Dr. (2 JUN) looks better /normal size. Heartbeat steadier and quiet but palpitations persist (extra heart beats felt in my throat); Overall body feeling stronger but chest muscles still weak and sore after ultrasound experience. Ringing in the left ear is better and milder twitches in chest at night. Teeth sensitive to cold liquids and Numb hands while walking esp 4 June; tense chest at work/home and need to step away and breath; Heart faster; long time to calm after warm/hot bath Currently late June still suffer from muscle weakness especially left chest, left arm where shot went in. Hands are still numb and Heart races when in bed.. Chest also still freezes up during work. Have to focus on breathing calmly. Overall though my condition continues to improve.

2 days after taking 1st dose ofvaccine, patient woke up with a lumpunder his armpit in the arm that wasinjected; Pocket of fluid in the armpit that spread towards the breast area.; This is a spontaneous report from a contactable healthcare professional, the patient. A 48-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 on 10Mar2021 (at the age of 48-years-old), as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Prior to 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 4 weeks prior to the COVID-19 vaccine. On 12Mar2021 (2 days after taking the first dose of vaccine), the patient woke up with a lump under his armpit in the arm that was injected. There was also a pocket of fluid in the armpit that spread towards the breast area. The patient was concerned to take the 2nd dose. The patient did not receive any treatment for the reported events. The events resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of axillary lump and axillary abscess were recovered with sequalae on an unspecified date in Mar2021. Information about lot/batch number cannot be obtained. No further information is expected.

Swelling in Lymph Node by collarbone on Left side next day and still have 5 day later. 4 days after vaccine having flu like symptoms

48 year-old man referred for admission from outpatient echo appointment after finding of large pericardial effusion. Patient's history includes iron-deficiency anemia from hiatal hernia and season allergies. Was in usual state of health until received second Pfizer mRNA Covid-19 vaccine 5/18/21. A few days later developed cough, 'brain fog,' dyspnea. Had remote outpt visit and treated with abx for sinusitis. Covid test was negative 5/28/21. Symptoms worsened and developed swelling of legs and abdomen, worse exertional dyspnea and had to sleep sitting up due to orthopnea. Began on lasix 20 PO BID as outpt with significant improvement in swelling and other symptoms over past week - thinks he lost 20 lbs. Still feels more bloated than usual. Had outpt echo as part of eval and sent to ED. Denies chest pain, palpitations, dizziness. Brain fog is improving. Mildly constipated. No black or bloody stools. No abd pain. PERICARDIAL EFFUSION (6/15/2021) Assessment: echo Large pericardial effusion noted mostly post and no echo evidence of tamponade. Smaller in size. no need for pericardiocentesis Discharge home on lasix 20 mg daily Net neg 5.4 L chest xray looks improved unbale to get thoracentesis due to not enough fluid Vitals stable

Arm just got a little swollen; This is a spontaneous report received from a contactable consumer (patient) via Medical Information Team. A 48-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: ER8736), via an unspecified route of administration in arm left on 21May2021 (at the age of 48-year-old) as single dose for COVID-19 immunisation. The family medical history relevant to AE(s) included cholesterol, high blood pressure and diabetes, really high on his dads' side of the family. The patient's medical history (including any illness at time of vaccination) included ongoing high blood pressure, he had high blood pressure for years, ongoing high cholesterol, he was diagnosed with high cholesterol about 2, maybe 3 years ago and pneumonia, the patient had pneumonia shots and never had any problems. The patient's concomitant medications included lisinopril, 12.5 mg, once daily, for blood pressure and atorvastatin, 40 mg, once daily, for cholesterol. Historical vaccine included Flu shots (FLU VACCINE VII), via an unspecified route of administration on an unspecified date as dose number unknown, single for an unspecified indication (the patient had flu shots). Prior vaccinations (within 4 weeks) were reported as none. The AE(s) following prior vaccinations were reported as none. Additional vaccines administered on same date of the Pfizer suspect was reported as none. It was reported that, the caller was a consumer called in regard to the Pfizer COVID-19 vaccine. Stated that, he had been seeing his doctor for about 3 weeks now and his doctor did not know what to do, so he advised the caller to contact Pfizer. The caller stated that, he got his first dose of the COVID-19 vaccine back on 21May2021 and then 3 weeks later, he came in on 11Jun2021 and got the number two shot. Stated that, the caller was unable to provide the NDC number or expiry date of the COVID-19 vaccine. Stated that, when the patient got the first shot, his arm just got a little swollen on 22May2021, but it was not red. Stated that, his arm did not show any signs of infection or anything, so it was just swollen and after a couple days everything was fine. The AE require a visit to emergency room was reported as no and physician office was reported as yes. The reporter seriousness for the event was reported as unspecified. The outcome of the event was recovered on an unspecified date in May2021. No follow-up attempts are needed. No further information is expected.

Severely bruised arm; Purple and blue size of soft ball have pictures; This is a spontaneous report from contactable consumer, the patient. A 48-years-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown); via unspecified route of administration in left arm on 02Apr2021 at 15:45 (at the age of 48-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 concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient was not diagnosed with COVID-19 prior to the vaccination. Since the vaccination, the patient had not been tested for COVID-19. On 02Apr2021 at 16:00 the patient experienced arm was severely bruised, purple and blue size of soft ball had pictures. No therapeutic measures were taken as a result of reported events. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The clinical outcome of the events severely bruised arm and purple and blue size of soft ball was unknown. No follow-up attempts are needed. information about lot number cannot be obtained.

On the evening of 1/6 patient started to develop flu like symptoms that continued through the morning of 1/7. Patient then begin to develop swelling in the left armpit/axillary region. As of 1/8 swelling was the size of an orange or grapefruit and described as being "almost like subcutaneous swelling." As of 1/8 the swelling could be seen through his shirt and looked like hypertrophy. Patient has taken photos for documentation.

Vaccine given at 07:50 (AM), with no immediate concerns. Within 4-6 hours, soreness at injection site was noted (soreness took 12-18 hours to start after first dose) By 8 hours after vaccination, had generalized "tingling" like a flu prodrome. By 12 hours after vaccination, experienced generalized aches, chills, mild headache and ipsilateral axillary lymphadenitis All symptoms persisted for 48 hours before resolution, except for axillary lymph node pain. Axillary lymphadenitis persisting , but resolving, by 72 hours after vaccination.

Headache, body aches, and large swollen lymph node under left arm. Headache and body aches started about 24 hours post vaccination and resolved after 12 to 18 hours. Swollen lymph node came on about 12 hours post vaccination and continued a good 72 hours. Took 3 doses of acetaminophen 1000mg (one each night at bedtime).

Swollen lymph nodes in armpit, sore arm at injection site, severe great toe joint pain; Swollen lymph nodes in armpit, sore arm at injection site, severe great toe joint pain; Swollen lymph nodes in armpit, sore arm at injection site, severe great toe joint pain; This is a spontaneous report from a non-contactable other healthcare professional. A 49-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were unknown), second dose on 06Jan2021 at 07:30, and first dose on 16Dec2020 at 10:45; both via unspecified route of administration on the right arm at a single dose for immunization. Medical history included asthma. The patient has no allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included diphtheria vaccine toxoid, tetanus vaccine toxoid (TD) on 29Dec2020 at right upper arm. The patient experienced swollen lymph nodes in armpit, sore arm at injection site, and severe great toe joint pain on 06Jan2021 at 21:00. The patient did not receive treatment for the adverse events. Outcome of the events was not recovered. No follow-up attempts are possible. Information on the batch/lot number cannot be obtained. No further information is expected.

prominent lower axillary swelling same side as shoulder injection site; Flu-like symptoms; soreness (other than injection areas including thighs); soreness (other than injection areas including thighs); more severe soreness/generalized soreness (other than injection areas including thighs); more severe soreness including back of shoulder; generalized weakness; This is a spontaneous report from a contactable physician (patient himself). A 49-year-old male patient received a second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK9231; expiry date: unknown) via an unspecified route of administration (right arm), on an unspecified date, at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received chlorhexidine and propylene glycol and experienced allergies. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date unknown) in the left arm on 17Dec2020 at 17:30 for COVID-19 immunization. On 08Jan2021, the patient experienced more severe soreness including back of shoulder, generalized weakness, and generalized soreness (other than injection areas including thighs) beginning at 13:00 following day lasting the rest of the day. On an unspecified date, the patient also had prominent lower axillary swelling same side as shoulder injection site, flu-like symptoms, and focal soreness. The patient received over the counter (OTC) Motrin as treatment for the events. The patient recovered from flu-like symptoms, but has not yet recovered from the remaining events.

left axillary LAD swelling Narrative: Left axillary LAD swelling occurring one day after 2nd dose of covid vaccine, leading to ED visit. No treatment given.

left axillary LAD swelling Narrative: Left axillary LAD swelling occurring one day after 2nd dose of covid vaccine, leading to ED visit. No Treatment given.

Woke up yesterday morning (1/20/21) flu like symptoms. Body ache, headache, stiff joints. Today woke with mass in armpit, injection side, left arm. About golf ball size, soft and squishy to touch. Flu like symptoms are gone. Has followed up with Dr. Currently treating with warm compress and seems to be helping pain

Allergic reaction that occurred 7 days after receiving the first vaccination. Treated for anaphylactic shock at local ER and released. Anaphylactic shock returned within 24 hours causing second visit to the ER. I was then transported to hospital for ICU admission. Body broke out with hives rash for several days followed by severe joint swelling. Remained in ICU 3 days and was released to see Allergist.

3 days after vaccine I developed edema in left hand and wrist, unable to make a tight fist+ swollen left neck supraclavicular lymph nodes+ left side/flank/chest (muscular) tightness. Visited PCP. Clear chest Xray, scheduled arm ultrasound to rule out blood clot

Bump and red rash around it. Started night after second shot. Still theren48 hours later. Painful to touch.

swollen left calf that was DVT, deep vein thrombosis; This is a spontaneous report from a contactable Other Health Professional. A 49-year-old male patient received 2nd dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL3248), via an unspecified route of administration on 11Jan2021 at single dose on left arm for COVID-19 immunisation. Medical history included hypothyroidism and high cholesterol. Patient had no known allergy. No COVID prior vaccination. No COVID tested post vaccination. Historical vaccine included 1st dose of bnt162b2 (lot: EK5730) via intramuscular on 23Dec2020 at 15:30 at single dose on left arm for COVID-19 immunisation. Concomitant medication included levothyroxine and atorvastatin. 1 week after receiving the 2nd dose, patient woke up with a swollen left calf. Ultrasound the same day (19Jan2021) showed that was DVT, deep vein thrombosis. Patient started taking apixaban (ELIQUIS) (blood thinner) the same day. Event resulted in doctor or other healthcare professional office/clinic visit. Outcome of the event was resolving. No follow-up attempts are possible. No further information is expected.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported event cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review 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.

Got the does on the 6th of January around 3:00pm Around 9a on the 7th my skin started to hurt then about about 9:00PM I developed chills Around 2 am the next day I woke up really hot also with chills 5AM 8th I noticed a 10cm soft lump on the left arm pit 22nd Completely resolved

Edema to mid calf with maximum of 1cm indentation. No history of previous episodes of edema. Slowly improved daily until completely gone 3/3/21

Swelling not at injection site. One day after the shot, my right finger swelled up for about 12 hours followed by swelling on the right side of my top and bottom lip. No treatment, just advised to keep an eye on it.

Patient administered COVID-19 vaccine. After waiting for observation patient complained of slight swelling below ear and not difficulty swallowing but "funny". Patient was offered and counseled on Benadryl. He accepted and was given 25mg oral diphenhydramine. Patient was observed for 30 minutes post administration. No further effect or complaints were observed.

Felt swelling in arm, third fourth and fifth finger on right arm became numb, tiny pinpoint red bumps appeared on arms and legs. Right eyebrow and extending down to the right cheekbone feels "puffy"

Had a very strong erection through night most of the morning; Very horrible side effects; very unusual side effects, Was pretty crippling; Lost my voice; Left groin is terribly painful; I go urinate and it would come back; was very really weird; Groin is so tender; Leg is uncomfortable; couldn't walk/Balance was off; I was on the floor; couldn't even make me anything to eat; Lethargic; I pee pretty frequently; Head, the base of head is very uncomfortable; Had sweats last night really strong; Couldn't sleep; Left buttock and all the way down to my toes was extremely painful; Body aches and chills; Glands swollen; Headache; Sick most of the day; This is a spontaneous report from a contactable consumer. A 49-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 19Feb2021 15:00 (Batch/Lot number was not reported) at singe dose for covid-19 immunisation. Medical history included genital herpes, TBI (Traumatic brain injury), chronic laryngitis, low blood pressure, seasonal allergy, appendix taken out, sinus surgeries, no sense of smell, tonsils removed, allergy. It was reported that he got her vaccine (unspecified Vaccine) Friday afternoon at 3 o'clock pm mountain standard time. He was fine on Friday and Saturday, he was horrible, very horrible side effects, that's why he thought he need to call, very unusual side effects he had typical, he was really struggling to talk today. On on 19Feb2021 23:00 he lost my voice, my glands were swollen, body aches he experienced. He got my shot in my left arm, my left buttock and all the way down, all the way to my toes was extremely painful and it cuts through my groin area. My left groin which is terribly painful. patient left buttock, all the way down to the toes extremely painful and that continued into my groin. And he had erection, he had a very strong erection through night, most of the morning. He go urinate and it would come back that was very really weird. That was when he knew it was really weird. And he knew that Pfizer was the one that makes Viagra. And my groin is so tender. When he pee, he pee pretty frequently. He think that was the most unusual side effects. His head, the base of my head was very uncomfortable. He had sweats last night really strong. Today, he woke up, he could not sleep, he went to the bed early. He had no energy today, he was doing a lot (not clarified over the call). He do have a headache today and obviously my voice hasn't come back completely and my leg is uncomfortable, he couldn't walk he was like if he was drunk yesterday, he couldn't, my balance was off. He was on the floor. He couldn't even make me anything to eat. It was pretty crippling that it made me feel like. He was very lethargic and he was sick most of the day. he was just hoping to give you information. He waited for long time on the phone to share experience. I hope this information helps you, I mean the other people if having the same problems or maybe not. Consumer also stated, he cannot locate the card that was given to me. He could not locate today. He was doing my laundry today maybe it is in my pocket. he dig into my pocket, he guess could not find it. They gave me card but he was not sure if he had it. Date when started experiencing the events: Consumer stated, I would say the date of the vaccine 19Feb2021. It probably towards the evening, I would say late at about 11 o'clock. Still experiencing Consumer stated, I am experiencing mild headache. I am experiencing dull pain at the base of my neck. I am experiencing the tenderness in my left groin. I am experiencing a little pain when I pee. I am experiencing a little bit of body aches, chills. I haven't fully gotten my voice back. I feel so sick. The erection has subsided but my penis is painful, it is uncomfortable. For treatment Consumer stated he did today he took this afternoon about maybe 3 pm, he took 4 Ibuprofen. Outcome of the event had a very strong erection through night most of the morning was recovering, outcome of the events lost my voice, left groin is terribly painful, groin is so tender, left buttock and all the way down to my toes was extremely painful, body aches and chills, headache not recovered. Outcome of the other events unknown. Information about lot/batch number has been requested.

My left under is Swollen - Puffy looking like a extra fat - My right underarm is normal - It does not hurt. It is not red or in-f lammed . But when i put my arm straight down against my side i can notice because of it being swollen in that location. I have not reported to my doctor yet.

Patient received 2nd covid vaccine. no reactions to first one. about 15 min after 2nd vaccine, spouse noticed patient with puffy forehead. Patient knocked on clinic door and began to ask question. brought pt into the clinic. noticed mild erythema to forehead, and to bilat arms upper chest and slightly on mid back. at the time no itching or pain or shortness of breath.

Swelling and mild tenderness of lower left axilla; possible lymph node; developed the day after the vaccine which patient states was "injected roughly". Pt describes swelling into left chest; was seen in the ER on 4/3-4/3/21, and seen via video visit with me on 4/5/21.

Sore arm, lasted 2 days. Swollen lymph node in collar bone area on right side. Still ongoing. Back and joint pain lasted 36 hours. Mild chills lasted 48 hours.

On Mon. 4/12/21, around 7:00am, in the shower, I discovered Swelling/Edema (equivalent to a jelly filled-doughnut) in my Right Arm Pit, that was tender to the touch and visually noticeable in terms of protrusion size, with slight discoloration.

I developed a headache within an hour of the shot. The following morning I developed a very swollen lymph node under my right arm pit. This has since migrated down my rib cage. I also experienced nausea, dizziness, headache, and muscle aches the following two days. Those have since subsided. The swollen lymph node under my arm is still with me today.

- Ringing in ears began about 2 hours after the injection and has persisted constantly for last 24 hours and is ongoing (most annoying) - Significantly swollen lymph nodes near injection arm - Low grade fever started around 18 hour point post injection - Headache overnight and until around lunch time - subsided now with Tylenol - Body aches began at 24 hour post injection

Swelling left leg. Femoral vein DVT identified on ultrasound on April 5, 2021 (partially occluded clot). hematologist switched me from Eliquis to starter pack of Xarelto.

Started experiencing some dizziness on March 8th that lasted for approximately 3 weeks. Did get the second dose of the Pfizer vaccine and a week later felt a sort of hot feeling in my head similar to that ballon sensation when first coming down with the flu but nowhere near as intense. The dizziness was worst on March 10th then slowly resolved itself over the next few weeks. It was mild to moderate in intensity, I could feel a continuation of movement after turning my head sideways, it felt like the head was still going. Strange. I was still able to go to work but the effect was noticable. The only variables in my life recently were beginning Humira on Feb 2nd 2021 and getting the series of Pfizer Covid vaccines on Feb 19 and March 12. I did notify my gasteroenterologist because at first I assumed it was the Humira. He said that is not a side effect. On further research I have seen a lot of people reporting vertigo several weeks out after the Covid shots as if the antibody formation produces and inflammatory response in the ear in some patients. Unknown the symptoms are related to the shot or not. I had one outbreak of Meniere's Disease in 2006 and has not recurred. Perhaps the vaccine can cause a recurrance?

1) arm joint pain (not strong) for both dose 1 and dose 2 2) swollen lymph nodes under armpit (left side). For dose 1, I did not feel the pain until one week after I took the shot. It took fours days to disappear. For dose 2, I felt stronger pain at the same place (left armpit) at the night when I took dose 2 shot (4/14/2021). Now 4/16/2021, I am feeling better and predict that it would be gone in days.

Severe pain in foot 1 day after injection. Pain increased about 4 hours after running. Doctor reported bursitis in the left foot heel.

bad chills, fever overnight, severe headache, body aches, shot site pain, and lymph node swelling and soreness

Approximately 10 minutes after vaccine administered patient reported itching on chest and funny feeling down both arms. Both palms had severe redness and welts on them, as well as some minor swelling. Patient was given 50mg of Diphenhydramine capsule and monitored for an additional 45 minutes. At time of leaving pharmacy the redness was still present on palms, but the white welts had gone down quite a bit. Pharmacist recommended patient go straight to urgent care for further treatment. Patient never had any difficulty breathing, speaking or swallowing during event.

Angioedema of right tongue prompting ICU admission. Treated with high dose steroids, Benadryl, epinephrine, FFP, TXA, Pepcid, and protonix with symptom resolution within 24 hours and discharge to home

Patient readmitted on 5/19 who was just discharged on 5/15. Patient initially presented with fever, SOB, lymphadenopathy, diffuse maculopapular rash. He had his first dose of COVID vaccine (Pfizer) on 4/23, and his symptoms began on 4/29. He was itchy all over, but when he developed fever and SOB he came to the ER on 5/2 and was discharged on prednisone. His symptoms continued and so he came back to the ER and was admitted. He had a lymph node biopsy to rule out lymphoma (pathology returned negative for lymphoma). He was treated empirically with ceftriaxone and doxycycline. He tested + for EBV IGG but not IGM. EBV PCR was pending upon discharge. He had a borderline positive lyme serology. He was discharged on doxycycline and steroids with improved symptoms. He returned to the ER with again worsening SOB, night sweats, worsening rash, recurrence of fever. He denies sore throat or any sick contacts. He reports a normal appetite. He was found to be hypotensive and in AKI.

Patient reports to the pharmacy 3 days after receiving the 2nd dose of his Pfizer vaccine, complaining of complete numbness and loss of sensation in both hands along with swelling of right hand. Vaccine was received on the afternoon of 5/29 and patient reports a loss of sensation in both hands beginning that evening. This has continued for 3 days up to today morning (06/01) where patient reports some improvement in degree of swelling of right hand and a return of some feeling in both hands.

The day after receiving the vaccine, some balls appeared in my chest at the level of the clavicle which have presented a lot of pain and inflammation that until today, Tuesday 06-02-2021, has not diminished.

Patient received 0.5 ml instead of 0.3 ml. Patient had no unusual adverse effects, only sore arm and swollen lymph nodes in armpit.

Anaphylactic reaction; skin was on fire; sweating; stomach cramps; throwing up; his arms and saw they were solid red; inflamed; hands swelled up; itchy; sore; sore where injected the Testosterone into left arm.; sore where injected the Testosterone into left arm.; This is a spontaneous report from a contactable consumer (patient). An 49-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 11May2021 16:45 (Lot Number: EW0182; Expiration Date: 31Aug2021) as 1st 0.3 ml single dose at the age of 49-years-old for covid-19 immunisation; testosterone cipionate, via an unspecified route of administration from 2020 (Lot Number: 88945; Expiration Date: 30Sep2021) and ongoing, at 150 mg, 2x/week (150 mg injection bi weekly ) for gonads, low testosterone. The patient medical history included low testosterone, gastrooesophageal reflux disease, COVID in the past (He did not know initially he had it, he had lost of taste and smell). Concomitant medication included dexlansoprazole (DEXILANT) taken for gastrooesophageal reflux disease from an unspecified start date and ongoing. None prior vaccinations (within 4 weeks). No family medical history relevant to AEs. No additional vaccines administered on same date of the pfizer suspect. The patient experienced anaphylactic reaction (medically significant) on 17May2021. Time of onset (24-hour clock): Roughly 18:00. Usually he took the testosterone in the morning, but he forgot. He was wrapping up the day, took the testosterone and by 18:02 he was on the ground, cold. The patient got his vaccination last Tuesday (11May2021). He was also on testosterone for gonadism. He usually administered the vaccine in his shoulders. He took the testosterone bi-weekly. On Monday he administered it his left shoulder and on Thursday it is in his right shoulder. After getting the vaccine he administered testosterone in his right shoulder on Thursday and had no issues. The patient mentioned everyone else who got the COVID Vaccine he knows had sore arm, nausea, but he did not have any of that. On Monday (17May2021) he injected his testosterone into the same arm/location, left arm, where he got the COVID vaccine and had an anaphylactic reaction. He contacted his doctor and went to the emergency room. The patient confirmed he felt like he had recovered completely from the anaphylactic reaction. Caller clarified the anaphylactic reaction. He did the testosterone injection in the same spot he had the COVID injection. Within 5 minutes it was like his skin was on fire. He was sweating, had stomach cramps, and was throwing up. Once he stopped throwing up he looked at his arms and saw they were solid red. They were all inflamed. His legs were inflamed. His hands swelled up. They were red. He had to take his wedding ring off. He was itchy. It was like he was on fire. He was sore, and sore where injected the Testosterone into left arm. He confirmed he had no problems swallowing or breathing. Based on the symptoms he was experiencing he realized these were things listed to be aware of when getting the COVID shot and to seek medical attention for. He went to the ER and they verified it was an anaphylactic reaction. Treatment included: He was given an Epi-Pen. It made him feel like off, like he had too much coffee or something. he was also given Benadryl and some Anti-Inflammatory to calm his body down. Investigations: He had blood drawn at the ER. However, he does not know if was actually tested. He was informed when the nurse drew blood it would be up to the doctor, but he has no knowledge if anything was done. Action taken of testosterone cypionate was dose not changed. Outcome of the events was recovered on 17May2021.

By the second day of ?second shot all of my symptoms from being sick (previously cured by 1st vaccination shot) returned with a vengeance. fatigue, shortness of breath, cough, sinus infection, ear infection, swollen lymph nodes, dizzy spells, fever off and on, muscle and joint pain.

per Spanish interpreter, pt had Pfizer vaccine, the 2nd dose on the 29th foot swollen and has hand tingling sx started on the 31rst, sx still present but improved vaccine given at marlin stadium lot number ew0153 first vaccine on may 8th no reaction

vision was off and even confusion; vision was off and even confusion; dizzy; showed the lymph nodes were inflamed; got hives; arm swelled; This is a spontaneous report from a contactable consumer. A 49-years-old male patient received first dose of BNT162B2 (Formulation: Solution for injection, Batch/Lot Number: ER8735), via an unspecified route of administration, administered in Arm Left on 16May2021 10:00 AM as DOSE 1, SINGLE for COVID-19 immunisation. The patient medical history included drug allergy to penicillin from an unknown date and unknown if ongoing. COVID-19 from an unknown date and unknown if ongoing. The patient concomitant medication included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) and sertraline hydrochloride (ZOLOF) taken for an unspecified indication, start and stop date were not reported. The patient was diagnosed with COVID-19 prior to vaccination and not diagnosed since the vaccination. The patient was not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient received shot on Sunday May 16th at 10 am, slept for 23 or 24 hours and would not eat or drink, second day better but arm swelled and got hives gave Benadryl and missed two day of work went back on Wednesday then on May 23rd, woke up dizzy and vision was off and even confusion, went to ER and started stroke protocol, did all testing including a chest x-ray that showed the lymph nodes were inflamed, kept treating as if a possible stroke, MRI machine down so they admitted and waited for machine next day was released after negative scan. The adverse event result in emergency room/department or urgent care. The patient received treatment with adverse event all testing for stroke protocols. Seriousness criteria was Caused/prolonged hospitalization. Since the vaccination, the patient has not been tested for COVID-19. The patient underwent lab tests and procedures which included chest x-ray: lymph nodes were inflamed on 23May2021, magnetic resonance imaging: negative scan on 23May2021, sars-cov-1 test positive: positive on an unspecified date. On an unspecified date, the events were resolved.

he had bruise sensation on both hand and feet,; faint blueness in his hand; swelling sensation on his hand and down to his feet; Swollen right hand; right bicep pain; This is a spontaneous report from a contactable consumer (Patient, self reported). A 49-years-old male patient received first dose of bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EWD162 Expiry date: Unknown), via an unspecified route of administration, administered in Arm Right on 08Apr2021 13:45 (at the age of 49-years-old) as dose 1, single for covid-19 immunisation. Medical history included asthma, thrombosis, Allergies, multiple sclerosis. Concomitant medications included colecalciferol (VITAMIN D [COLECALCIFEROL]) (vitamin D or multivitamin, as reported). The patient previously took copaxone (glatirarmer acetate) and experienced hypersensitivity. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19, Since the vaccination, patient has not been tested for COVID-19. On 08Apr2021 23:00, the patient experienced swollen right hand, right bicep pain, on unspecified date he had bruise sensation on both hand, feet, faint blueness in his hand and swelling sensation on his hand and down to his feet. No treatment received for Swollen right hand and right bicep pain. The Outcome of events swollen right hand, right bicep pain was not recovered, for other events was unknown. Additional Context: Caller reported that the swelling and pain he reported in the online form is a moving target. Caller reported that it seems to be getting a little worse right now. Caller inquired how long he should wait and what he should receive to treat his AEs. Caller inquired if he should need to seek a physician, does he need to contact his primary care physician or can he go to an urgent care. Caller reported that he is experiencing adverse reactions following the first dose of the Covid-19 vaccine on 08Apr2021. Caller stated that he is looking for advice on where he should go now. Patient stated that he was "sick and tired" of trying to report this situation to Pfizer and that he believed that the Pfizer marketing team does not want to receive these type of reports. Response: Captured his information to make an e-report, attempted to transfer call unsuccessfully. Caller already reported his reaction on the webpage. Product: PFIZER-BIONTECH COVID-19 VACCINE Question: Patient wants to know if he could request for his second dose of the Pfizer COVID-19 vaccine to be half the dose of the first one if he improves his condition by the time he is supposed to receive the second dose, he received the first dose of the Pfizer COVID-19 vaccine on April 8th and is scheduled to receive the second dose on April 29th, he does not want to receive a second full dose because of the adverse reactions that he developed when he received the first dose: he had bruise sensation on both hand and feet, faint blueness in his hand, swelling sensation on his hand and down to his feet that cause a discomfort sensation specially on his left cap, the swelling sensation is primarily on his right side (he received the shot on his right side) his major discomfort is on his left cap, somedays he feels better somedays worst but the side effects wont go away, as an underlying condition he has thrombosis and is very susceptible to medications, he mentioned that in the past other medication (not from Pfizer) "almost kills him". He previously reported this situation he provided a reference number of: 4m2qfn1l and was trying to reach out from this department, call was attempted to be transferred but lines were to busy, caller stated that he made a previous report on the web page and that he did everything that was in his hands to report this situation to Pfizer and that he is sick and tired of trying to report this to Pfizer. During the call he mentioned that for his own safety he might not get the second shot of the vaccine as it might have stronger side effects that the first dose, eh also stated that he forgot to report something the night he received the shot. e transmitting AE duplicate. Caller asked not to be contacted back. Response: Alternative dosing regimens of Pfizer-BioNTech COVID-19 Vaccine have not been evaluated. The decision to implement alternative dosing regimens resides with health authorities; however, we at Pfizer believe that it is critical for health authorities to conduct surveillance on implemented alternative dosing schedules to ensure that vaccines provide the maximum possible protection. Per PI, Dosing and Revised: 06 April 2021. The Pfizer-BioNTech COVID-19 Vaccine is a suspension for intramuscular injection administered as a series of two doses (0.3 mL each) 3 weeks apart. Follow-up attempts completed. No further information expected.

Since vaccination patient has been treated in office for swollen lymph nodes, shingles and DVT right lower extremity

When the pt went to get his 2nd shot he stated that approx 5 days prior his L arm was red, swollen, and bruised

I had swelling of my shoulder and left arm. I also had pain down my neck and fingers in my left arm. This went away in about 4 days. The only remaining symptom was pain in my index finger on my left hand.

headaches, fever, heavy sweats at night, chills (which lasted for 8 days), shortness of breathing, red patches spread over cheeks, neck and body (which started on the 5th day and most visible on the 8th day). Up to today (July 11th), still experiencing shortness of breath, fatigue, lack of focus, and mild coughing

Diffuse Right shoulder and upper arm pain starting 2 weeks and 3 days after second dose of Pfizer vaccine; in addition to Rt axillary lymphadenopathy 2in x 2in, painful, starting 2 weeks and 1 days after second dose of Pfizer vaccine, symptoms are still present, recommended OTC Tylenol as needed and follow up with primary care provider for further evaluation and treatment

Site: Pain at Injection Site-Medium, Systemic: Joint Pain-Medium, Systemic: Lymph Node Swelling-Medium, Additional Details: 1 week and 1 day after second Pfizer COVID19 vaccineat CVS Pharmacy 5254, 7/4/21, noticed pain to entire Rt shoulder and upper arm which waxes and wanes, unable to describe pain, sometimes only occurs on outer right upper arm and other times radiates to shoulder or upper arm, present for 2 weeks and 3 days now, noticed pain and swelling also to Rt axilla on 7/6/21, present for 2 weeks and 1 day now;

Bacterial infection due to unspecified staphylococcus; Joint infection; Difficulty in standing; Postoperative complication; Difficulty in walking; Pain; Swelling; Knee pain; Swelling of R knee; Folliculitis; This is a solicited report based on the information received from a contactable consumer by Pfizer (Mfr. Control No.: 21K-163-3877815-00). A 49-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot number was not reported), dose 1 intramuscular on 14Apr2021 as dose 1, single (at the age of 49 years) for COVID-19 immunisation; adalimumab (HUMIRA), subcutaneous from 2015 (Batch/Lot number was not reported) to 17Jun2021, at 40 mg (40 mg,1 in 2 wk) for hidradenitis, rheumatoid arthritis. The patient had a relevant medical history of Diabetes. Patient had Shellfish allergy manifested by itchy throat and swelling. Non tobacco user. No alcohol use. Concomitant medication(s) included olmesartan (OLMESARTAN) taken for blood pressure abnormal. On an unspecified date in Apr2021, the patient experienced folliculitis. On 18Apr2021, the patient experienced on and off right knee pain and right knee swelling. On an unspecified date in May2021, the patient experienced bacteria culture got positive staph infection to right knee joint. On 14May2021, the patient experienced right knee infection. On 19May2021, the patient experienced could not stand for more than two minutes after surgery/difficulty in standing for number of minutes and walking around, could not stand for more than two minutes after surgery, difficulty in standing for number of minutes and walking around, recurrent pain and recurrent swelling. On 30Jun2021, the bacteria culture got positive staph infection to right knee joint resolved. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On 18Apr2021, patient had pain and swelling to right knee. On 21Apr2021, patient went into the doctor and was diagnosed with staph infection to right knee joint. On 23Apr2021, patient had surgical intervention for knee. Patient had been recovering in the hospital with intravenous antibiotics. On 14May2021, patient started with right knee infection and patient had right knee infection surgery on 21May2021. Patient also mentioned that it was an unknown right knee infection. From 20May2021, patient shared that patient was hospitalized for a week and a half due to right knee infection. On May2021, patient was tested for bacteria culture and got positive for staphylococcus infection. While admitted his physician cleaned and flushed the infection on his right knee. On 30Jun2021, patient added that his infection was gone when patient had another bacteria culture follow up. Patient was also treated with antibiotics for eight weeks and was given hydrocodone for pain. On 23Jun2021, Patient also started physical therapy since patient had difficulty in standing for a number of minutes and walking around. Patient mentioned that patient missed his last Covid-19 vaccine dose because patient was hospitalized. Patient took unrecalled blood pressure medications His Humira was also placed on hold until patient fully recovered from the infection. Primary reporter did not have the lot number information, because the packaging was discarded. The patient underwent lab test which includes Bacteria Culture Test: Positive for Staphylococcus infection on an unspecified date in May2021; Bacteria Culture Test: Normal on 30Jun2021. The outcome of event Staphylococcal infection was recovered on 30Jun2021, for Joint infection was recovered on an unspecified date in 2021, for Difficulty in standing, Difficulty in walking, pain, Swelling was not recovered, for Folliculitis was recovered o an unspecified date in Apr2021, for Knee pain recovering and for Swelling of R knee was unknown. Causality for HUMIRA 40MG/0.4ML(ADALIMUMAB): The reporter's causality for the event(s) of could not stand for more than two minutes after surgery/difficulty in standing for number of minutes and walking around, bacteria culture got positive staph infection to right knee joint, difficulty in standing for number of minutes and walking around, recurrent pain, recurrent swelling and folliculitis with Humira 40mg/0.4ml(Adalimumab) was a reasonable possibility. The reporter's causality for the event(s) of right knee infection, on and off right knee pain, could not stand for more than two minutes after surgery and right knee swelling was not provided. opinion is that there is no reasonable possibility that the events of could not stand for more than two minutes after surgery/difficulty in standing for number of minutes and walking around, on and off right knee pain, could not stand for more than two minutes after surgery, difficulty in standing for number of minutes and walking around, recurrent pain and recurrent swelling are related to HUMIRA 40MG/0.4ML(ADALIMUMAB). Change History: On 09Jun2021, received updates to patient demographics, medical history, event information, reporter opinion of causality, company opinion of causality, company alternative etiology, suspect drug information, concomitant drug information and narrative description. The events of "could not stand for more than two minutes after surgery", "right knee infection" and "could not stand for more than two minutes after surgery" were added. the event of "right knee pain" was amended to "on and off right knee pain". the event of "on and off right knee pain" is now considered serious. On 01Jul2021, received updates to event information, reporter opinion of causality, company opinion of causality, company alternative etiology, suspect drug information, concomitant drug information, treatment drug information, laboratory/diagnostic procedures, narrative description and medical history. The events of "difficulty in standing for number of minutes and walking around", "recurrent pain", "recurrent swelling" and "folliculitis" were added. the event of "could not stand for more than two minutes after surgery" was amended to "could not stand for more than two minutes after surgery/difficulty in standing for number of minutes and walking around". The event of "staph infection to right knee joint" was amended to "Bacteria culture got positive staph infection to right knee joint". No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on the information provided in the narrative, the reported events of Staph infection, arthritis infective, dysstasias, arthralgia, joint swelling, gait disturbance, pain, swelling and folliculitis the suspected vaccine BNT162B2 cannot be completely excluded but also consider the possibility of known medical history of rheumatoid arthritis. However, the event of post procedural complications due to is consider unrelated and mainly due to surgical procedure. 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.

Acute Pericarditis. Patient was admitted from 12/27-12/28/2020 at hospital by cardiology team who strongly felt the acute pericarditis was due to the Pfizer Vaccine (Dr. was senior cardiologist).

Swollen arm pit, puffy, achy, not red or warm. Noticed about 36hrs after that had ache under arm pit. Visually swollen. Took naproxen helped with pain but not swelling.

Malaise, alternating sweats and chills, and 1.5cm left axillary tender lymphadenopathy persisting > 72hrs after vaccination without any evidence of erythema, edema at administration site

1/12/2021 @ 2200hrs - Muscle/body aches, injection site tenderness 1/12/2021 @ 2300hrs - Muscle/body aches, chills 1/13/2021 @ 0300hrs - Muscle/body aches, chills, fever of 99.0, general malaise 1/13/2021 @ 0600hrs - Muscle/body aches, chills, tired, no energy, difficult to get out of bed. Did not go to work. 1/13/2021 @ 1000hrs - Symptoms continued. Advil 600mg PO taken. Allowed sleep from 1030-1230hrs. 1/13/2021 @ 1230hrs - Woke up feeling damp as if having had night sweats. Rested the entire day. 1/14 to 1/15/2021 - Left arm site tenderness with raised hard area at site of injection. Left armpit raised/swollen, appears as lymphadenopathy.

100.4 F temperature; swollen lymph node in armpit of injection arm; This is a spontaneous report from a contactable consumer (patient). A 50-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248), via an unspecified route of administration at right arm on 11Jan2021 at 07:00 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 11Jan2021 at 23:30, The patient experienced 100.4 F temperature and swollen lymph node in armpit of injection arm. The patient outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.

1ST DOSE: 4-5 D AFTER SWALLEN WITH LIMITED ROM ALSO SHOULDERS SLEEPY - ALL RESOLVED IN ABOUT 10 DAYS 2ND DOSE: SAME SX AS AFTER THE 1ST DOSE, BUT MORE SEVERE, MORE JOINTS AND BACK STIFF - IMPROVING BUT NOT COMPLETELY RESOLVED IN 10 DAYS

fever; my lighter weight facial fillers swelled and were painful (around the eyes - not my lip fillers); my lighter weight facial fillers swelled and were painful (around the eyes - not my lip fillers); numbness in both hands; This is a spontaneous report from a contactable pharmacist (patient). A 50-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EK4176, expiration date not reported), intramuscular on the left arm, on 07Jan2021, at 11:30 at a single dose for Covid-19 immunization. The patient has no medical history and no known allergies . There were no concomitant medications. The patient previously took the first vaccine of bnt162b2 on 18Dec2020, at 12:00 PM, Intramuscular, on the Right arm for Covid-19 immunization, he had numbness in his right hand x2 days. On 09Jan2021, following second dose, he has had numbness in both hands x2 days and on 10Jan2021, day 2, he ran a fever and his lighter weight facial fillers swelled and were painful (around the eyes - not my lip fillers). His eyes have a mix of Juvaderm products. It spontaneously resolved after 1 day with a subjective loss in overall volume. Density of the product used seemed to be a factor in the response. He knows this has been reported with the Moderna product, but he does not believe is has been reported with our product. It appears the response may not be product specific, but more specific to the type of vaccine. The patient has no Covid prior vaccination and not covid tested post vaccination. No treatment was received for the events. Outcome of the events was recovered in Jan2020.

After 12 hours I was awoken with painful large swelling and lymphadenopathy in left axillary area. Area swollen caused pain in lateral, external chest area and axillary area with swelling approximately 10 x 6 cm. Area still swollen and painful 48 hours after vaccination on 29 JAN 2021 prompting report.

Painful swollen lymph nodes along left clavicle noticed 2/4/21 at 6pm still present and painful. Swollen lids under eyes (mild) noted on 2/6/21 have now subsided after 2 hours.

Client reports swelling in left armpit, assuming lymph node swelling, on Friday evening (over 48 hours after COVID-19 Vaccine #2 was administered in left deltoid). At time of reporting (2/9/21 at 1100) client reports progression of swelling from left armpit to left side of stomach. Client reports "it looks like [he's] gained about 15 pounds on the left side of my body" from armpit to stomach. Client reports he is having no pain or discomfort, but feels "a noticeable pressure from fluid buildup on left side of body." Client went to see internal medicine physician 2/9/21. Physician was not concerned at current state but instructed client to monitor and call physician if pain occurs or if swelling noticeably worsens. When asked if swelling was worsening each day, client states it is hard to tell due to the shifting of fluid and "maybe settling due to gravity."

left hand swelling. entire hand and fingers. not arm or lymph nodes. just hand. painful and difficult to make a fist and bend fingers

body aches/chills/headache/lymphadenopathy L sided (side of injection) - all resolved except of significant Left axillary lymphadenopathy - swelling was the size of small melon, non-tender, rather uncomfortable. Next day, it got a bit smaller - about size of large fist, but still present, day 4. Post auricular and posterior cervical Left lymph nodes were also enlarged and tender, but not to the same extend.

Patient experienced swelling of the left side of face and mouth after vaccination. Patient taken to ED by EMS.

Patient had a reaction within 2 hours after returning home from the vaccination. Patient had to go to Hospital ER 24 hours later. Angioedema Was put on IV with steroids' and antibiotics to bring down the angioderma

I received the shot around noon on Tues March 16. I was fine until 3am Wed March 17 when I woke up general body soreness and sweats. I had Covid in March 2020 and the feeling was similar without the coughing and much shorter timeframe. That continued until about 3am on Thursday March 18 when I thought I was almost back to normal. When I woke up at 6am I thought I was ok but then I realized I had a lump under my left armpit on my side seemingly like my lymph node is swollen. That continues as I write this at 341pm on Friday March 19. I also developed hives on my right bicep and on my left and right buttocks and left and right hamstrings. this is itchy. I no longer have the soreness, sweating or fatigue but i have the swollen and what seems to be allergic reaction symptoms of hives.

Patient received vaccination at 1:45 PM on 3/16/21. Woke up at 3:00 AM on 3/17/21 with difficulty breathing. Went to ER where he was diagnosed and treated for angioedema secondary to a vaccination. Given IV steroids and benadryl. Discharged home with oral prednisone, hydroxyzine and epi pen. ECG, cardiac enzymes, CT neck negative for any acute process. Patient has a history of stephens johnsons syndrome secondary to taking Bactrim. Followed up with PCP on 3/25/21. All symptoms had fully resolved.

30 minutes after receiving Pfizer COVID vaccine #1 pt reports he became very flushed and hot and fatigued. Itching started later that night. Face felt swollen but no difficulty breathing, swallowing. I saw him the following day via telehealth and he reported generalized redness was improving but not resolved and pruritis persisted but was improving but the hour.

1. Around March 20th, 7 days after the vaccination, felt mild pain between left ear and temple. Pain was more if the head is shaken or if I jump. This pain disappeared on 27th March. 2. On March 26th both the feet are swollen , left foot more than the right. I still feel slight numbness in the feet today on March 28th. 3. On March 27th , around noon, a blood clott showed up on my left palm , it caused intense pain in the arm for 10 minutes before starting to subside itself. I felt a lump in my palm , it was visible in dark color ,about 1 cm in size. I still feel it in my palm today on 28th March.

Thurs: Shot 7pm, no adverse effects Friday: Face very red, allergic/histamine type reaction; begin OTC antihistamines Saturday: Massive facial and genital swelling Sunday: Same, PCP prescribed 4mg Prednisolone; symptoms lessen after 4 hours, most symptoms unnoticeable by 7pm Monday 7am; Less intense, but significant facial swelling, no genital swelling Fatigue during entire episode Antihistamines seem to yield little to no improvement Steroids help but it is now a tennis match overnight

Swollen lymph node in left arm pit; Fever; cough; headache; body aches; chills; This is a spontaneous report from a contactable consumer (patient). A 50-year-old male patient received the second dose of BNT162B2 (Solution for injection, lot number: EL3248, Expiration date; unknown), in the left arm on 08Feb2021, 05:00 AM at single dose for COVID-19 immunization. The patient historical vaccine included first dose BNT162B2 (lot number: EL3248) left arm on 30Jan2021, 05:45 AM at single Covid-19 immunization. The patient's medical history and concomitant medications were not reported. Patient did not have allergies. The patient experienced fever, cough, headache body aches and chills on 08Feb2021 at 12:00 AM. The patient was recovering from the events. On the next day, patient reported swollen lymph node in left arm pit on 09Feb2021 at 05:00 PM, the outcome of event were not recovered. Adverse event resulted in emergency room/department or urgent care. The patient performed ultrasound blood tests and received Motrin prescription for the adverse event another event fever, cough headache, body aches chills on 08Feb2021 at 12:00 AM. Patient did not receive any vaccine in four weeks. and did not have covid prior to vaccination. No follow-up attempts are possible. No further information is expected.

Inflammation of the face, jaw area extending from the left ear to the lower part of the jaw near the neck and to the middle of the cheek

Patient presented to ED with two day history of hives over body. Received treatment for anaphylaxis in ED including Epi-Pen, Pepcid, Benadryl, and Solumedrol. Patient initially hypotensive.

No immediate reaction but 5 days later (April 1) lymph nodes on neck were painful but went away after a day. But nausea and loss of appetite which started 5 days later on April 1 still remain as of today 4/7. It doesn't prevent me from eating or any other problems just definitely not myself. What's even more strange is my desire to drink 7up because of feeling sick. Haven't drank this stuff in over 30 years. But the feeling of nausea triggered past memoires of drinking 7up to feel better.

Pain and swelling in the axillary area. Tylenol used for pain, no relief. Symptoms started sometime yesterday (4/7/21) and have not improved.

Two to three hours after injected, I bit my inner lip several time while eating. My wife said left side of face seem swelling. The next morning has symptoms of Bell's Palsy. Left side of face seem paralysis. As days progress, the symptoms was more obvious. Text doctor on Sunday and Doctor office called on Monday and recommend i go to ER to confirm .

Vaccine administered 9.20am. Fatigue shortly after vaccine was administered - slept most of afternoon. Injection site pain - feels like been punched in arm. Headache in the evening. Night chills and complained of "tight" (not acute) chest pain... but no breathing problems. Morning fever of 101F. Headache, Dizzy, Fatigue, Muscle Pain (esp in legs, asif he had "run a marathon"). He spent most of the day "resting". Evening on day two, we noticed a large bump under his vaccinated arm. Radius about 5cm - larger than what I know swollen lymph nodes to look like - almost looks like a bicep between his armpit and nipple. Tender to touch. Morning of day three (48 hours after vaccine) bump under his arm remains and all other symptoms seem milder.

Fatigue and slight fever lasting 72 hours first onset 24 hours after injection. Swollen lymph node under right collar bone starting 24 hours after injection and lasting 72 hours.

3 days after shot I developed a rash on my neck, torso ,arms and hands. My thumbs where swollen and numb. I developed a fever ranging from 101 to 104.4 for 48 hours. intense body achs.

Severe anaphylactic shock Hives, Rash, etc.. Started 3/29/2021 lasting until 4/15/2021 Still feeling off

Severe allergic reaction anaphylactic shock Hives, rash,swelling, headache, stomach ache, body aches, elevated heart rate, uncontrollable body spasms, loss of appetite

Swelling of facial tissue on right side lower jaw..started morning after injection and still present??have started Benadryl

Patient is here with complaints of left calf pain. Started after returning from city on 4/12. Drove home. Was very sore, treated with aspirin. Helped at first but now pain and swelling have persisted. Did go jogging while on vacation and thought this may have attributed, now more concerned about DVT. Brother with history of blood clots but is a smoker.

Diagnosed as Guillain-Barre syndrome; This is a spontaneous report from a contactable consumer (patient himself). A 50-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 16Feb2021 12:00 (Batch/Lot number was not reported) at the age of 50-year-old as single dose for covid-19 immunisation. The patient was health and had no medical history. The patient had no known allergy. Concomitant medication included finasteride (PROSCAR); lorazepam; hydroxyzine. There was no other vaccine in four weeks. The patient was diagnosed as Guillain-Barre syndrome on 24Feb2021 16:00. The event resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event), disability or permanent damage. The patient was in hospitalization for 8 days. The patient had no COVID prior vaccination and had been tested post vaccination. The patient underwent lab tests and procedures which included covid (blood test): negative on 01Mar2021. Outcome of event was recovered with sequel in 2021. The patient received IVIG Infusion therapy for 5 days for event. Information on the lot/ batch number has been requested.

headache; unable to maintain an erection/ some issues with maintaining an erection; soreness in his arms/ soreness was on both shoulders; real soreness" in his arm where he got the injection/ injection site had pain; developed a "large lymph node under that arm", which he "feels internally"/ lymph node he could feel internally/ internal bone like pain; This is a spontaneous report from a contactable consumer (patient). A 50-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration on 31Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE at the arm right (reported as right shoulder) for covid-19 immunisation (reported as he is trying to avoid serious illness). The patient medical history includes sleep from unknown date and if ongoing. Concomitant medication included zolpidem (reported as generic ambien) taken for sleep, start and stop date were not reported and added that he has been taking it for years but he hasn't taking it since he got the vaccine but thinks he took it the day before. The patient previously took bnt162b2 first dose on 10Mar2021 (roughly two weeks before the second dose) at the left shoulder for covid-19 immunisation. It was reported that the patient had no reaction to the first dose of the Pfizer-BioNTech COVID-19 vaccine, and he received the second dose on 31Mar2021. He explained following the second dose, his first issue was a "headache", then he had "real soreness" in his arm where he got the injection. He added he developed a "large lymph node under that arm", which he "feels internally". He specified he still feels it a week later. He also explained he is "unable to maintain an erection". He described himself as "athletic" and specified not having erectile problem in the past. He asked if his current symptoms have been reported as side effect to the vaccine. It was also added that after the second dose he appeared to have some issues with maintaining an erection on 04Apr2021. It was stated he is fairly active with a muscular build and could be a result after an exercise injury but this did happen after his second shot. Caller states he also had soreness in his arms and an enlarged lymph node under his arm that he could feel with his hand but that went away yesterday (from 01Apr2021 to 07Apr20210). The soreness was on both shoulders but he thinks the soreness on the other shoulder is from lifting weights and the shoulder from the injection site had pain, internal bone like pain (from 01Apr2021 to 07Apr20210). It was stated that the lymph node he could feel internally but didn't protrude through skin and went away yesterday and lasted 6-7 days. It was also reported that the soreness and lymph node went away yesterday and believes everything will get back to normal, he expected soreness to last a couple of days and it lasted a week. The patient stated he took some sleep medication after the second injection. He doesn't remember if it was the night before the injection. He took Ambien, a higher dosage. States maybe issues with maintaining an erection are beginning to improve. It was also stated the soreness and lymph node he noticed it the day after the injection, by the evening of 01Apr2021 and as of yesterday 07Apr2021 evening it feels like its completely back to normal. It was noted for the treatment that he didn't take anything but bought a gripper where he squeezes it and builds strength in his hands to give him some relief. The patient added that he's pretty active, he works out 4-5 days a week, including running. The outcome of the event some issues with maintaining an erection/ unable to maintain an erection was recovering; for the event headache was unknown, for all other events was recovered on 07Apr2021. Information about the Lot/batch number has been requested.

Swelling of lymph node under shoulder that was injected. This swelling is the size of a tangerine and painful. Symptoms are persisting at this point in time which is three days later

The lymph nodes in my neck have swollen. I have been experiencing a very sore throat. It is hard to swallow. I was diagnosed today with strep throat and prescribed amoxicillin-clavulanate to address the strep throat.

I received the Pfizer vaccine on 21 December 2021. On December 27 I developed a fever, cough and was diagnosed with Covid-19. About 14 days later I started to get a rash on hands and feet with burning sensation. I was evaluated and diagnosed with Covid toes. About 1 week later I developed a fever and was evaluated and diagnosed with pneumonia, pulmonary embolism, and a DVT. I continue to get worse to include arthritis in hands, wrists, feet and ankles. I was admitted to the hospital with worsening pneumonia, reactive arthritis and a rash on elbows, knees, hands and feet. I was in the hospital for about 5 days. I have been evaluated by rheumatology, pulmonary and dermatology since. The ongoing theory is I have a reactive arthritis from COVID and may have developed psoriasis/psoriatic arthritis.

Headache and overall mild body aches on the first day post-vaccination. Treated with fluids, ibuprofen, and rest. Resolved after one day. Swelling and tenderness in left underarm lymph node noted two days post-vaccination. Tenderness increased on day three. Managed with fluids and ibuprofen.

Angioedema; Generalized urticaria (hives) all over trunk, arms, buttocks; This is a spontaneous report from a contactable consumer (patient). A 50-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: ER8737; Expiration date was not reported) on the left arm on 06Apr2021 (13:15) as a single dose, with route of administration unspecified, for COVID-19 immunization at the pharmacy/drug store. Medical history included type 2 diabetes, hypertension (HTN) and obesity. Concomitant medications included atenolol, amlodipine, metformin hydrochloride, sitagliptin phosphate monohydrate (JANUMET) and simvastatin. The patient previously took buproprion (WELLBUTIN), and had drug allergy. On 07Apr2021 (14:00), the patient had angioedema and generalized urticaria (hives) all over the trunk, arms and buttocks. The events had resulted into doctor or other healthcare professional office/clinic visit. The patient had received methylprednisolone (MEDROL) as treatment for the reported event. The outcome of the event was not recovered. The patient did not have COVID-19 prior to vaccination, and had not been tested post-vaccination.

8 days post vaccine patient developed rash on left arm that spread to b/l arms and legs. Over the next few days developed increased fatigue, severe joint pain, fever and worsening rash. Was seen in ER on 4/23/2021. Extensive work up showed increased CRP, Eosinophilia, increased LFTs, increased WBC. Skin biopsy was taken and revealed Superficial and deep perivascular and interstitial dermatitis, histiocyte-predominant and with eosinophils. ANA was positive 1:640, Ferritin was elevated. The patient was admitted. . Patient had CT scan of the chest on 4/28/2021 which showed bilateral pulmonary embolism and possible mass in the right side of the liver. Patient was started on anticoagulation. Next day, patient had severe abdominal pain with pain in the right lower quadrant. He as found to have Ogilivie's Syndrome with colon ischemia and peritonitis. Now s/p resection with septic shock. The patient is in the ICU and intubated.

At 17 days, I can see a red mark; I have a scab at the injection site 9 days after vaccination; Cold sore outbreak in the corner of my mouth 6 days after vaccination; couple days after vaccination I noticed my joints felt crunchy, like there was plastic wrap in them.; noticed a small scab there that was still kind of oozing a bit; If I push on the muscle there it's slightly sore; the other arm is not.; This is a spontaneous report from a contactable consumer (patient). A 50-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 06Apr2021 at 13:45 (Lot Number: EW0151) as SINGLE DOSE for covid-19 immunization. Medical history included cold sore outbreak in the corner of mouth from an unknown date (had them before in the same spot, but less than once a year and usually a lot smaller). 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. On 12Apr2021, the patient had cold sore outbreak in the corner of his mouth 6 days after vaccination. On 15Apr2021, the patient had scab / small sore at the injection site 9 days after vaccination. On an unspecified date of Apr2021, about a week after vaccination, the patient noticed a small scab there that was still kind of oozing a bit. The patient also reported that, on an unspecified date in Apr2021, if he pushed on the muscle there it was noticed that the muscle was slightly sore; the other arm was not; couple days after vaccination he noticed his joints felt crunchy, like there was plastic wrap in them. 15 days after vaccination, he still had a scab. At 17 days, on 23Apr2021, he saw a red mark where the scab was formed. No corrective measures were taken by the patient. The outcome was reported as not recovered for the event cold sore mouth, vaccination site scab and recovered on an unspecified date in Apr2021 for a small scab there that was still kind of oozing a bit and unknown for rest of the events. No follow-up attempts are needed. No further information is expected.

I had a swollen upper left side , arm, and chest , severe pain, a uneasy feeling, and sharp or weird throbbing type pain ever so often. After a week of the symptoms getting worse and not stopping I went to the emergency room.

allergic to something in the shot./systemic histamine reaction; swollen lips; lips were flaking, skin flaking; lips were flaking, skin flaking; massive facial angioedema/complete relapse of allergy/angioedema; fatigue; penis redness/penis was also "sheet red" and swollen; penis was also "sheet red" and swollen; itching; very very red face; This is a spontaneous report from a contactable consumer (patient). A 50-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 50-year-old, dose 1 via an unspecified route of administration, administered in right arm on 25Mar2021 19:00 (Lot Number: ER8730; Expiration Date: 31Jul2021) as 1st dose, single for COVID-19 immunisation. Medical history included known allergies to spring pollen, oak birch, and ash. Concomitant medications included cetirizine hydrochloride (ZYRTEC) and levocetirizine dihydrochloride (XYZAL) taken as allergy medication. On 25Mar2021, the patient got the shot, waited 15 minutes, no problems. On 26Mar2021, woke up to a very very red face. On 27Mar2021, massive facial angioedema, fatigue, itching, notable penis redness, his penis was also "sheet red" and swollen. The patient started 4mg prednisolone on 27Mar2021, kept facial swelling and allergies at bay, mostly, but a very close rate to not keeping up. On 02Apr2021, swelling subsided and mostly was getting back to "normal", however lips were flaking, skin flaking. On 04Apr2021-week of, things got better, very swollen lips but everything reasonably in check. On 12Apr2021, the face re-firing red at approx 1pm, slept until 6pm, and complete relapse of allergy/angioedema. Trip to Emergency room (ER), given shot of Kenelog in the arm, released. On 13Apr2021, no improvement, steroids ended 6 days after the patient started taking them, 2nd trip to ER with epinephrine shot, no improvement; blood taken, white blood cell count normal. On 14Apr2021, allergist appointment and he was told that he was allergic to something in the shot triggers pollen allergies, rosacea, etc. 50mg prednisone 5 days, 40mg 5 days, etc. He states that it was a systemic histamine reaction. On 26Apr2021 starts up again, mild, contact me. The patient doesn't know what to do with the second vaccine in general and he had called and they say no on him getting number 2. He was terrified of vaccines now because of his reaction. He also says that he was not hospitalized but he went to the emergency room twice. The patient would like to know if there have been any reports of those who had a similar reaction to this getting the second dose of the vaccine and how they reacted. He states that he has been told that he should not get the second dose but wonders if he were to get another COVID-19 vaccine other than Pfizer, if he would have the same reaction. The event allergic to something in the shot/systemic histamine reaction resulted to doctor or other healthcare professional office/clinic visit. The event massive facial angioedema/ complete relapse of allergy/angioedema resulted to emergency room/department or urgent care. The patient was treated with steroids for the events. The outcome of the event massive facial angioedema/complete relapse of allergy/angioedema was not recovered while for the rest of the events was recovering.

An enlargement showed up on my lower right neck below the Adam's apple. It was painful when chewing or sneezing or pressing it. I put cold compress every night and drank lots of water. It disappeared on the 3rd day.

2 days after my 2nd shot my throat started to hurt and lymph nodes on my neck got very swollen. The issues continue for 10 days at which point I went to urgent care and they prescribed antibiotics. My test for strep throat and mono came back negative.

Admit date: 5/2/2021 Age: 50 y.o. Discharge date: 5/4/2021 Discharged Condition: good Disposition: Home Principal Diagnosis: Acute pancreatitis without infection or necrosis Other Active Diagnoses: Present on Admission: o Acute pancreatitis without infection or necrosis Issues to be Addressed Post Discharge: 1. Referral to GI to review episode of pancreatitis, isolated episode with quick recovery, to review need for further evaluation 2. Follow-up with PCP for discharge follow-up

nurse stated it could possibly be blood clots; Patient is afraid he is going to have a stroke or scared he had one after the COVID-19 Vaccines; blurred vision in right eye that comes and goes; ringing in his left ear; Very fatigued throughout the day, sleeping a lot/tired and sleeps a lot; Very fatigued throughout the day, sleeping a lot/tired and sleeps a lot; Date received First dose: Third Friday in Feb2021/Received second dose on 12Apr2021, six weeks after first dose; Date received First dose: Third Friday in Feb2021/Received second dose on 12Apr2021, six weeks after first dose; Fullness in face; Body aches; Brain fog: At times he can't do the simplest things. He will look at the clock on the wall and says he knows what it is, but can't find the words to say. Cannot carry on a conversation intelligently; Brain fog: At times he can't do the simplest things. He will look at the clock on the wall and says he knows what it is, but can't find the words to say. Cannot carry on a conversation intelligently; Brain fog: At times he can't do the simplest things. He will look at the clock on the wall and says he knows what it is, but can't find the words to say. Cannot carry on a conversation intelligently; headache all over the back of his head/Affecting his balance. In back of head, moves around, sometimes the front; headache all over the back of his head/Affecting his balance. In back of head, moves around, sometimes the front; feeling dizziness/had to stop driving; This is a spontaneous report from a contactable consumer (patient's wife). A 50-years-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 12Apr2021 (may have been in morning) (Batch/Lot Number: Unknown; Pfizer COVID-19 vaccine) as 2ND DOSE, SINGLE for covid-19 immunization, at the age at vaccination of 50 years old. The patient's medical history and concomitant medications were not reported. History and Investigations: Doesn't take any medications. Has no medical conditions, unless age was considered a medical condition. Historical vaccine included first dose of COVID-19 Vaccine reported as on Third Friday in Feb2021 (First dose: between 1430-1530), and experienced AEs: Brain fog; Headache: Thinks in the back of the head, but moved around too, sometimes in the front. Has affected his balance. Dizziness: Had to stop a couple times while driving home from vaccine facility. Aches and pains. All symptoms from the first dose went away within 3-4 days. Caller would say patient recovered completely from symptoms associated with first dose. The patient experienced nurse stated it could possibly be blood clots on an unspecified date with outcome of unknown, patient is afraid he is going to have a stroke or scared he had one after the covid-19 vaccines on an unspecified date with outcome of unknown, brain fog: at times he can't do the simplest things. he will look at the clock on the wall and says he knows what it is, but can't find the words to say. cannot carry on a conversation intelligently on 12Apr2021 with outcome of not recovered, headache all over the back of his head/affecting his balance. in back of head, moves around, sometimes the front on 12Apr2021 with outcome of not recovered, feeling dizziness/had to stop driving on 12Apr2021 with outcome of not recovered, blurred vision in right eye that comes and goes on an unspecified date with outcome of not recovered, ringing in his left ear on an unspecified date with outcome of not recovered, fullness in face on 12Apr2021 with outcome of not recovered, body aches on 12Apr2021 with outcome of not recovered, very fatigued throughout the day, sleeping a lot/tired and sleeps a lot on an unspecified date with outcome of not recovered, date received first dose: third friday in feb2021/received second dose on 12apr2021, six weeks after first dose on an unspecified date with outcome of unknown. Patient was caller's husband. Had both doses and had the same problem. His experience is very bad with the second dose and has had it for a month. Within a day after the first dose, had brain fog, headache, and dizziness where he had to stop driving a couple times. This went away within a few days. Patient and caller were concerned about the second dose. They spoke with patient's doctor and the local Health Department, both said it couldn't be from the vaccine. Patient was advised to get the second dose. Had the same symptoms with second dose, but occurred within an hour of received second dose. Symptoms have continued. Also experiencing blurred vision in right eye that comes and goes. Patient had an appointment with his doctor this week, but the doctor basically didn't look at him. Doctor advised patient to see a neurologist. Another nurse stated it could possibly be blood clots. Caller is trying to find help. Caller wanted to add with the second dose, patient experienced ringing in his left ear, fullness in his face, and headache all over the back of his head. Was feeling dizziness after second dose and had to stop driving. Patient is afraid he is going to have a stroke or scared he had one after the COVID-19 Vaccines. If the COVID-19 Vaccines woke up some other health issues, patient wants to get it taken care of. Received second dose on 12Apr2021, six weeks after first dose. Got second dose at a different location. Second dose COVID-19 Vaccine AEs: Started experiencing symptoms within an hour. Headache: Affecting his balance. In back of head, moves around, sometimes the front. Comes and goes. Brain fog: At times he can't do the simplest things. He will look at the clock on the wall and says he knows what it is, but can't find the words to say. Cannot carry on a conversation intelligently. Dizziness. Blurred vision in right eye: Doesn't know if this started on 12Apr2021 or a couple days after. States as the day goes on and he gets tired, it will worsen. It comes and goes. Ringing in left ear: Began on 12Apr2021 or a few days after. Fullness in face: Stated this comes and goes, but has stayed the same. Documented as provided. Body aches: Comes and goes. Seems to worsen as the day goes on. Very fatigued throughout the day, sleeping a lot: He's tired and sleeps a lot. It was hard for him to get out of bed. Caller stated patient's symptoms worse as the days goes on. Patient never experienced pain at the injection site. Guesses patient received COVID-19 vaccines in his left arm because the county was doing a dive-thru clinic. Since he didn't get out of his car, she believed patient would have received the vaccines in the left arm. The events REQUIRE A VISIT TO Physician office: Doctor doesn't think anything is wrong. ER: Not yet. Is considering going to the ER today. PRIOR VACCINCATIONS WTIHIN 4 WEEKS was None. RELEVANT TESTS: None. Events Clot blood and stroke considered medically significant. Follow up attempts are needed. Information of Lot/Batch number has been requested.

PT RECD 2ND DOSE PFIZER VACCINE ON 5/4/21, HAS BEEN HAVING SWOLLEN LYMPH NODES AND DIFFICULTY BREATHING WHICH CONITNUED FOR THE PAST 2 WEEKS. PT DID NOT SEE MEDICAL CARE, BUT RETURNED BACK TO OC FAIR POD TO RECEIVE MEDICAL CARE. PARAMEDICS ASSESSED PT, VSS, LUNGS CLEAR, WAS OFFERED TRANSPORT TO HOSPITAL BUT REFUSED. HE WILL GO TO HOSPITLA BY HIMSELF.

swollen supraclavicular lymph node on right side where shot was administered. pt said it started about 24 hours after the shot

Low Limb Edema. Legs, ankles, Feet. Went to Urgent Care, admitted to ER, they did blood work and head CT test. Was given Lasix, (diuretic) to reduce water weight in legs. Have had to take 2 rounds of Lasix as swelling continues. Currently not taking Lasix, and swelling seems to be increasing again. Going in for heart echo (resting) Tuesday June 15 to see if myocardial or pericardial inflammation exists, since leg, ankle, foot swelling is a symptom of those.

Pt received vaccine on 6/14 at 2 pm. Pt woke up that night with arm pain but thought it was normal injection site reaction. She woke up 6/14 with a swollen arm, unable to lift or move arm, wit radiating pain to the head, neck, and chest.

Reports onset of "return of Covid symptoms" almost immediately (fever, chills, diarrhea, shortness of breath, loss of taste and smell, jaundice). Followed by extreme symptoms as of May 7th including fever above 104 degrees Fahrenheit. Pt first seen by medical professional on May 11. Patient was hospitalized May 15 and remained hospitalized until June 1 and was treated for multiple infections and sepsis during hospital stay.

Pt received his 1st Pfizer vaccine on 3/31/21 and presented to the emergency room with chest pain on 4/16/21 that was ongoing x 1 week. he also reported some shortness of breath. he reported a cold feeling on the side of his chest as well. he also was feeling his heart racing at times. he denied any recent illness, fever or chills or hx of covid 19 infection, he was evaluated and sent home to follow up with his primary care and cardiology if his chest pain returned. He then received his 2nd pfizer COVID-19 vaccine on 4/21/21 and called the hospital on 6/18/21 reporting that since the second vaccine he was experiencing a weird feeling of coldness to his ears, vertigo and dizziness and has suddenly developed a fixed, hard, kidney bean sized lymph node to the r side of his neck. he now has to have imaging and work up with possible biopsy of the lymph node. He reported he has not felt right since his vaccines were given .

swelling of tongue; difficulty breathing; headache (bad one); numbness in right side; confusion; swelling of face; slurry words; This is a spontaneous report from a contactable other healthcare professional. A 50-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EM9810, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on 10Feb2021 at 09:00 am (age at vaccination was 50 years) as 1st dose, single for COVID-19 immunization. Medical history included asthma. The patient had known allergies to iodine, shrimp and iodide (like the CATSCAN contrast fluid). Prior to vaccination, the patient was diagnosed with COVID-19. Concomitant medications included colecalciferol (VITAMIN D [COLECALCIFEROL]) and One-A-Day Mens over 50 vitamin. The patient previously received first dose of flu shot in upper right arm on 12Jan2021. The facility where the most recent COVID-19 vaccine was administered was Hospital. On 10Feb2021 at 15:00 pm, the patient experienced swelling of tongue, face, confusion, slurry words, difficulty breathing, no pains though, headache (bad one) and numbness in right side. The patient received treatment with DECADRON (steroid) and Diphenhydramine (Benadryl). Since the vaccination, the patient has been tested for COVID-19. The patient underwent Nasal Swab COVID test (COVID Nasal/Nasopharynx COVID test) on 28Feb2021 and the result was negative. The outcome of the events was resolved on an unknown date in 2021. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on a positive temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events. 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.'s friend stating 06/11/2021 after receiving vaccination difficulty breathing, swelling of the face, dizziness/weakness, on/off fever, chills. Edema of both legs (Left more swollen), no seeping. No physician seen.

After first injection a visible swelling of my lymph node in my right neck. I did some online research wwhich lead me to conclude that this side effect was possible in people that had Covid prior to the vaccination. (I tested positive in July of 2020). I also concluded it would go away. I went to my 2nd injection appointment as scheduled and on site I inquired about my (still) swollen lymph node and the nurse assured me it would go away. After my second injection my lymph nodes under both arms became VERY visibly swollen and my neck swelling increased. I spoke with a friend who had a similar issue and he said his went away after 11 days after his second shot. I waited 11 days then went to Urgent Care. The tests performed are listed as well as I can (I lost my test result paper)

the patient reported that after he received his second done he stated experiencing numbness and tingling in his face and his legs feel "funny" and get swollen from time to time

edema to the lower extremities; distended abdomen; allergic reaction; This is a spontaneous report from a contactable consumer or other non hcp (Patient's friend). A 50-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Batch/Lot Number: EW0196 and expiration date was not reported), via an unspecified route of administration on 10Jun2021 (at the age of 50-years-old) as dose 1, single for COVID-19 immunisation. The medical history and concomitant medications were not reported. On 11Jun2021 the patient experienced edema to the lower extremities, distended abdomen and allergic reaction. It was reported that the patient had the vaccine on 10Jun2021 and was due for his second dose in two days, right after the vaccine the following day got a severe reaction which caused edema in his lower extremities and distended abdomen, the reporter asked if the adverse reactions were going to persist and if the patient should get the second dose of the Pfizer BioNTech Covid-19 vaccine. The reporter wanted to see what side effects there were for the vaccine and what they should do and if he should continue to get the next dose which is due in 2 days since the patient had this allergic reaction. The reporter was informed that in general, local side effects, the ones on the arm where the shot was given (such as injection site redness and injection site swelling) were mostly mild-to-moderate in severity and resolved within 1 to 2 days. Side effects that are experienced throughout the rest of body (systemic side effects) including fever and chills were observed with the first 1 to 2 days after vaccination and resolved shortly thereafter. Side effects after second shot may be more intense than the ones experienced after first shot. These side effects are normal signs that body will building protection and should go away within a few days. The vaccination provider or healthcare provider should be called if any side effects are experienced that bother or do not go away. The reporter was informed that not to get the Pfizer-BioNTech COVID-19 Vaccine if one had a severe allergic reaction after a previous dose of the vaccine or if 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. The reporter was asked to speak to a healthcare provider about the risks of the vaccine compared to the risks of potentially not being fully protected against COVID-19 infection. The outcome of all the events was unknown.

Appox mid May 2021 noticed a strage feeling when swallowing and slight enlargement of L lymph node. Lack of other indications decided to give it 2 weeks to resolve. 07 June presented to my PCP, referred to ENT on 10 June. Subsequent biopsy showed Malignant Neoplasm BOT. Referred to specialist.

swelling in right hand.; headache; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ep7533) via an unspecified route of administration in the arm left on 31Mar2021 at 12:30 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history reported as cancer survivor. The patient's allergies to medications, food, or other products were reported as nine. 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 medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Apr2021 at 09:00 the patient experienced swelling in right hand and had headache. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of events. The clinical outcome of events swelling in right hand and headache were resolving at the time of this report. No follow-up attempts are needed. No further information is expected.

Starting 1 week after second dose; ear ringing, just getting better Starting from 3 weeks after second dose to now: swollen hands, feet, ankles, tingling pain along tibia bones, brain fog, joint pain whole body, nuscle weakness and twitching

neck and arm glands were inflamed; had swollen lymph node on the left side of his neck; This is a spontaneous report from a contactable consumer. A 50-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date in Apr2021 (at the age of 50-year-old)(Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included ongoing rheumatoid arthritis. Concomitant medication included etanercept (ENBREL, Solution for injection in pre-filled syringe, lot number: 1125680, expiry date: 31Aug2023) taken for rheumatoid arthritis, start and stop date were not reported. On an unknown date in 2021, the patient stated his neck and arm glands were inflamed, when he was vaccinated with COVID-19 vaccine early this year and resolved. It was further reported on an unknown date in 2021, the patient had swollen lymph node on the left side of his neck. The event outcome was recovered in 2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

I took the first shot, the side of my foot swelled up/ When I got the first shot of Pfizer side of my foot swelled up; This is a spontaneous report from a contactable consumer (patient). A 50-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: solution for injection, Lot Number: EW0167, Expiry date: not reported) via an unspecified route of administration on 30Apr2021 (age at vaccination 50-year-old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included hypertension and kidney transplant from an unknown date and unknown if ongoing. Concomitant medications included tacrolimus (PROGRAF) taken for renal transplant and amlodipine taken for hypertension, start and stop date were not reported. On an unspecified date, patient stated that he was having real bad side effects, so he took the first shot, the side of his foot swelled up. Patient stated that taking Tylenol but its not working. The outcome of the event was unknown.

Dizziness, shortness of breath, swollen hands and fingers, shaky blurred vision. all occurred 2 hours after giving the shot. Patient was given benadryl and felt better in about 1 hour, he went home and the next day came back to work normal

Recipient was seen one day after the 2nd dose of vaccine was received and complained of Headache, Swollen lymph node, and Chills

Large reactive axillary lymphadenopathy; First dose: 17Nov2020, second dose: 07Jan2021; This is a spontaneous report from a contactable healthcare professional. A 51-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685), intramuscular on left arm on 07Jan2021 16:15 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (lot number: EJ165) for COVID-19 immunization on 17Nov2020 18:45 at left arm and tested positive for COVID test/Nasal Swab on 27Dec2020. The patient experienced large reactive axillary lymphadenopathy on 08Jan2021 that resulted in emergency room/department or urgent care. The patient took a CT scan as treatment with unknown results. The outcome of the event was unknown.

he had 102.1 temp; he started not feeling well; chills; ringing in ears/ The ringing was in both ears; body aches; joint aches; fatigue; lymphadenopathy/had swollen lymph nodes like the size of an apple; he was uncomfortable; His eyes were also hurting; The light bothered his eyes; This is a spontaneous report from a contactable Other HCP (patient) and a contactable Nurse (patient's wife). A 51-year-old male patient received the 2nd dose of bnt162b2 (BNT162B2, Batch/lot # EL3246, Expiry Date Apr2021) at single dose at left arm on 11Jan2021 18:00 for Covid-19 immunisation, administered at hospital as being a certified registered nurse anesthetist (CRNA). The patient medical history was none. There were no concomitant medications. The patient received the 1st dose of bnt162b2 (BNT162B2, lot # EK5730, expiry: 31Mar2021) at single dose at left arm on 23Dec2020 for Covid-19 immunisation and he has been fine, no adverse effect occurred. No additional vaccines administered on same date of BNT162B2. The patient experienced lymphadenopathy which is a size of tennis ball under my left armpit /had swollen lymph nodes like the size of an apple in his left arm in the axillary area, where he received the vaccine on 12Jan2021, he started not feeling well on 12Jan2021 around 9.00, he had 102.1 temp Fahrenheit on 12Jan2021 17:00, chills on 12Jan2021, ringing in ears/ the ringing was in both ears on 12Jan2021, body aches on 12Jan2021, joint aches on 12Jan2021, fatigue on 12Jan2021, his eyes were also hurting on an unspecified date in Jan2021, the light bothered his eyes on an unspecified date in Jan2021. The patient underwent lab tests and procedures which included body temperature: 102.1 fahrenheit on 12Jan2021, he was uncomfortable on 12Jan2021, body temperature: 100 and something fahrenheit on 13Jan2021. The outcome of lymphadenopathy/had swollen lymph nodes like the size of an apple was worsened, of he had 102.1 temp, ringing in ears/ the ringing was in both ears was not recovered, he started not feeling well, his eyes were also hurting, light bothered his eyes was unknown, chills, body aches, joint aches, fatigue was recovered on 13Jan2021. Course of events: Around 9AM on 12Jan2021 he started not feeling well. By the time he got home from work he had 102.1 temp Fahrenheit around 5PM. Temp was ongoing. His eyes were also hurting. The light bothered his eyes. He can't put his arm down. His left arm in the axillary area, where he received the vaccine, had swollen lymph nodes like the size of an apple. He had chills, ringing in ears, body aches and joint aches, and fatigue 12Jan2021. He was uncomfortable. The ringing was in both ears. On 13Jan2021 his temp was one hundred and something. What is concerning was the swelling in the armpit in the arm he received the vaccine in. It was very painful. It was starting to radiate up his arm. He did not go to the doctor, since he was relatively healthy. No event required a visit to Emergency Room or Physician Office. The reporting Nurse assessed the events he had 102.1 temp, His left arm in the axillary area, where he received the vaccine, had swollen lymph nodes like the size of an apple as serious as medically significant. The reporting Nurse assessed the events he had 102.1 temp, His left arm in the axillary area, where he received the vaccine, had swollen lymph nodes like the size of an apple, chills, Ringing in ears, body aches and joint aches, and Fatigue as related to BNT162B2.; Sender's Comments: Based on a compatible temporal association and known product safety profile, causality between events lymphadenopathy and fever and BNT162B2 COVID-19 vaccine cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

GI upset, spiked fever after the first shot. Was ten days before I could leave the house. After second shot had flu like symptoms( 2 days after) Had hives and had angioedema event.

Injection site pain started a few hours after 1st dose COVID vaccine and hasn't fully resolved five weeks later. Range of motion is fine. Second dose was given slightly lower and with deltoid pulled out slightly by the vaccinator and wasn't painful. I saw my sports medicine doc yesterday (2/12/21) for routine follow-up to a right rotator cuff tear and had her examine my left shoulder as well. She says her exam of the L shoulder is consistent with bursitis and the history and exam suggest the 1st dose of the COVID vaccine was a bit too deep and at least some of the vaccine got into the bursa. I'm a physician working in public health with occupational exposures to COVID, so I'm concerned whether or not the vaccine will be effective if the first dose was injected deep to the deltoid.

Enlarged lymph node in armpit on side of injection. Became sore and tender for 24hrs then started to resolve. Now 72 hours after injection and continues to improve. Had similar reaction to flu shot in September but not as severe.

swollen lymph node under his left arm; I feel tingling in my arm; I turn my neck to the right side, I feel like little pain on the neck side; This is a spontaneous report from a contactable consumer (patient). A 51-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EK9231) via an unspecified route of administration on 23Jan2021 at a single dose for COVID-19 immunization. Medical history included blood pressure (abnormal) and diabetes. Concomitant medication included lisinopril for blood pressure, amlodipine, atorvastatin and metformin for diabetes. The patient previously received first dose of BNT162B2 on 02Jan2021 for COVID-19 immunization. The patient had his second shot of his COVID 19 vaccine and then the first day was okay but the second day (24Jan2021) was, he had like swollen lymph node under his left arm. And also, he felt tingling in his arm. And when he turned his neck to the right side, he felt like little pain on the neck side. "I don't know if this will go away or what. This is the third day I had the vaccine." Consumer stated, "I took Ibuprofen." The patient underwent lab tests and procedures which included lab on an unspecified date with unknown results (the patient don't have it, his primary care have it). Outcome of the events was not recovered.

Dizziness/felt woozy/light headed; Weakness; vision changed; increased heart rate/heart rate went up slightly; had pressure in his head; pressure in his hands and feet like he could not move his feet; pressure in his hands and feet like he could not move his feet; headache; muscle tightness/muscles tightened in his back and in his calf muscles/tightness in his neck; he felt like he was just not himself; lethargic; lump in his throat; lymph nodes got tight on the same side as the vaccine/lymph node on his left side was tight throughout his neck; cringing in his stomach muscles; kind of like a muscle spasm in his stomach; didn't sleep that well last night; wobbly; back was hurting; muscle pain; This is a spontaneous report received from a contactable consumer (patient). A 51-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EZ9261, expiry date: unknown), via an unspecified route of administration, from 01Feb2021, at single dose, for COVID-19 immunization. Medical history included anemia (anemic), inflammation, acid reflux (esophageal), pain, on blood thinner, high cholesterol, sinus disorder (sinuses), overactive bladder/bladder control, acid reflux, stools hard (to soften stool), nerves, blood pressure high (high bp), car accident, and costochondritis in chest. Concomitant medication included atorvastatin calcium for high cholesterol from an unspecified date and ongoing; docusate sodium to soften stool; famotidine to soften stool from an unspecified date and ongoing; garlic [allium sativum] as blood thinner from Nov2020 (3 months ago) and ongoing, gabapentin for nerves from an unspecified date to an unspecified date and from Nov2020 (got back on this 3 months ago) and ongoing; hydrocodone for pain; iron for anemia from Nov2020 (been taking this for the last 3 months) and ongoing; meloxicam for inflammation, omeprazole (PROTONIX) for acid reflux from an unspecified date and ongoing; tadalafil for overactive bladder/bladder control from an unspecified date and ongoing; vitamin c (ascorbic acid), colecalciferol (VITAMIN D), vitamin b for trying to build up his immune system; ranitidine hydrochloride (ZANTAC) for sinuses; "One a Day Men's" from 2016 and "50+" (as reported, pending clarification). On 01Feb2021, after the shot, the patient experienced dizziness/felt dizzy and had weakness. When he walked to the desk to check out he felt his vision changed and his heart rate went up slightly but it did go down once he sat down but he felt woozy and had pressure in his head and pressure in his hands and feet like he could not move his feet. He was kind of like dizzy and light headed. He walked somewhere to sit down, he stayed 30 minutes and left after and sat 30 minutes in the car and he got a headache and his muscles tightened in his back and in his calf muscles and he felt like he was just not himself. He felt lethargic and felt like his lymph node on his left side was tight throughout his neck. He felt like his lymph node was getting tight and he just sat until he felt like his symptoms had dissipated. He also had lump on his throat. He had stuff going on with his stomach like cringing in his stomach muscles, it was kind of like a muscle spasm in his stomach. He didn't sleep that well last night (01Feb2021) as he felt some symptoms come on again, the tightness in his neck again and when he sat up, he got dizzy and wobbly, his back was hurting, his calf muscle was tight. He felt more muscle pain. He checked his blood pressure and it was good, but he just felt a little dizzy on 02Feb2021. The patient stated that all his symptoms have improved since 01Feb2021. The patient also mentioned that the girl looked really young (referring to the person who administered the vaccine), "maybe she jacked it up, he knows it supposed to be a very little bit, maybe she put more in him than she was supposed to". He went back to his doctor as he wants to come off of some of his medications because he is supposed to have another shot and he want to take the second shot. He wanted to stop taking all the medications around the second shot in case it was his medications that caused it. The patient asked since he had complications with the fist dose, should he still take the second dose. The patient was recovering from the events.

Fever started 2 days after vaccination, followed by shortness of breath, dyspnea, weakness and pain and edema in both legs. edema was traveling up and reached umbilicus. Weakness in both legs. Started to improve with steroids. When steroids were starting to taper, symptoms worsened again. Patient was seen in ED.

The night after receiving the second dose of the Pfizer Covid , the patient developed severe headache, who body myalgias, severe fatigue, and fevers. The next day he also developed pleuritic chest pain and shortness of breath. He described the chest pain as like a heart burning sensation, worse lying down and better sitting up. He documented a fever to 100.8 deg F. By the thord day the fever had resolved but the chest pain persisted, leading him to present to the emergency department. On exam he had BP 113/84, HR 95, RR 18, O2Sat 95% on RA, Temp 97.5 F. His lungs were clear to auscultation. Heart was RRR, S1, S2 WNL without MGR. ABD was soft, without tenderness, masses or HSM.

1st Shot on 2/22/21, no adverse reaction aside from injection side muscle pain. 2nd Shot on 3/15/21, vaccine administered at 15:15EST, after going home, became very tired around 17:30, took nap, woke up at 21:30 with pounding headache and the "chills." Went to bed at that time, took ibuprofen for headache, Slept through morning alarm on TUE 3/16 at 05:15, woke up at 08:45, in to work by 10:30. Left work at 13:30 due to continued headache & body aches, chills, (had to turn a space heart on in my office), hands were cold. Took nap from 16:00 - 19:00. Still had headache, body aches, and chills. Went to bed around 21:15. Woke up on WED 3/17 at 01:30, had the chills, and was shivering, still had head ache. Turned up the thermostat from 70 to 75. Put an extra blanket on the bed. Woke up at 03:30, t-shirt and blanket soaked in sweat. Woke up for day at 05:45. Right underarm swollen, (lymph gland/nodes). Experiencing runny nose, body aches, headache continues.

Patient first reported feeling a tingly/"prickly" feeling down his left arm and left shoulder, we advised patient to stay an extra 30 minutes for closer monitoring. About 15 minutes later his left knuckle began to swell with some redness, patient reported no difficulty breathing and no itching of the throat. Pharmacist decided to give Diphenhydramine 50mg IM after patient consented. The swelling and redness began to subside within 10 minutes. Patient received a ride home from family due to drowsiness from the Diphenhydramine

Shortly after receiving the injection my arm went ice cold all the way to my fingers and warmed up again quickly. On the way home (about an hour later) I noticed numbness and tingling in my hand and that has continued since (11 days as of this report). My upper arm muscle was sore later that evening and by the next day the pain in my upper arm was extreme. I couldn't move my arm without extreme pain. I took some tylenol late in the day and that did help cut down on some of the pain. I also put an ice pack on my upper arm but it didn't help. The pain wasn't as bad the next (3rd) day but it's still significant enough for me to restrict activity with it. There is also a burning sensation off and on as well as itching deep in my arm. My upper arm has also felt like there is a tight band around it (since day 2) although the muscles themselves don't feel like there's any tightness or knots. I took ibuprofen on day 10 and it helped a little but not a whole lot. At this point I also have what feels like swelling or tenderness under my arm near the armpit area. The pain, burning and itching in my upper arm continues as well as the numbness, tingling and pins all up and down my arm to my hand and fingers.

patient stated his arm swelled and hurt the next day. His lips swelled but he could not take Benadryl. He took a Claritin instead

Apparent allergic reaction with face swelling. No recent changes to diet, exposure, or medicines. I plan to see a doctor prior to getting second shot on 4/12.

Patient reported red bumps "breaking out" over both his lower arms. He states that he is experiencing itching along these areas. He also stated he was having slightly worse breathing due to his COPD. Pt states he is also allergic to benadryl. I advised the patient to reach out to his PCP if his condition worsens.

I had hives (itchy and redness on neck, head, and chest and minor face swelling, onset about an hour after injection. No trouble breathing. I took a dose of Benadryl . The symptoms started going away and only lasted 2 to 3 hours.

Within 24 hours I developed chest pain about 2 inches to left of sternum. Within another 24 hours the pain shifted another 2 inches towards my left armpit. Pain can be slight to intense at times requiring me to sit down. Within 24 hours I developed a painful bump in the trapezoid about halfway between neck and shoulder. The bump has gone down now (day 10) but the pain continues. It?s relatively constant throughout the day but gets severe enough towards the evening to stop or minimize the use of my left arm. It seems to be activity related. The more I need to do that day, the worse it is in the evening. Pain in left arm has been as expected but continues at day 10. It is slowly subsiding and is minimal compared to the other two pain locations.

swelling in right hand; infection swelling/ index finger swelling still; pain; This is a spontaneous report from a contactable consumer (Patient). A 51-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9265), at left arm via an unspecified route of administration on 04Feb2021 12:00 (at the age of 51-year-old), as a SINGLE DOSE for COVID-19 immunization. The patient medical history were not reported. The patient had no known allergies. The patient not had COVI-19 prior vaccination; not tested COVID-19 post vaccination. Concomitant medication included Atorvastatin (LIPTOR [ATORVASTATIN CALCIUM]). Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient received Lipitor within 2 weeks of vaccination. Patient not diagnosed COVID-19 prior to vaccination. On 4Feb2021 at 16:00, the patient had swelling in right hand and he stated that he could not index finger swelling still and pain is going away. Patient received antibiotic for event infection swelling and not received any treatment for the pain. At the time of this report event outcome was recovering. No follow-up attempts are needed. No further information is expected.

I was extremely fatigued with muscle soreness especially in my left arm pit. As of 4/18/2021 I noticed a large knot/lymph node in my arm pit and the soreness was constant.

Herpes-type cold sores around mouth and anus and ulcer on tip of tongue. Along with flu-like symptoms including fever, muscle aches, chills, headache, stomach pain, diarrhea, nausea

Day 7, intense headache for no reason that lasted for 3 hours, with chills. 3-4 hours later experienced tingling on lip and within 15 minutes a large cold sore developed on the lip, along with a tender node under chin beneath the sore, leading up to a sore throat. Also noticed the day after both shots I was highly sensitive to the sun and my forehead got discolored blotchy red/brown (similar to a bad sunburn but without the pain) that took a day to mostly go away, but still has hints of it. Cold sore is subsiding but expect it to last at least a week. Haven?t had them in a long time, but recognize it.

I received my 2nd Pfizer dose on 4/23 at 2:40 pm at the Essex fair grounds 24 hrs later my joints were on fire and I have a massive swelling in my left arm pit same arm i received the injection it is very sore and swollen

Reports after the vaccine his arm has become swollen and hard. It will go away, but then it comes back. Today in office it was indurated slightly. Reports on and off flushing and body aches that are new- feels like a toothache

Swollen glands in neck at collarbone, arm pit and groin area upon awaking on day three. All swollen glands were on the side the injection was given, and are visible to the naked eye. Physician advise taking Benadryl and consult them in 24 hours if effects continue. First dose side effects were shaking, rapid heart rate, and lethargic, lasting 2 weeks. These side effects were not present with second vaccine at this time.

he reports discoloration resolved but developed worsening bilateral lower extremity edema; lower extremity pain and swelling; lower extremity pain and swelling; blue toes on both feet; extensive deep vein thrombosis in left lower extremity requiring treatment and thrombectomy; legs were cool to touch; This is a spontaneous report from a contactable physician reporting for a patient. A 51-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular on 02Apr2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation, at 51 years old. Medical history included triplegia, neurogenic bladder, hyperlipidaemia, chronic abdominal pain, type 2 diabetes mellitus, chronic opioid use, known allergies: Latex from an unknown date and unknown if ongoing. No other vaccine in four weeks. No COVID prior vaccination and was not tested for COVID post vaccination. The patient's concomitant medications were not reported. The patient previously took sulfamethoxazole;trimethoprim and experienced allergies to Sulfamethoxazole-trimethoprim. The patient experienced lower extremity pain and swelling, lower extremity pain and swelling, blue toes on both feet, extensive deep vein thrombosis in left lower extremity requiring treatment and thrombectomy, legs were cool to touch on 02Apr2021; and he reported discoloration resolved but developed worsening bilateral lower extremity edema on an unspecified date. Clinical course was reported as follows: The patient presented to the hospital on "4/7" (as reported) with lower extremity pain and swelling. Patient reports received 1st dose on pfizer vaccine on 4/2 (as reported) and immediately noticed blue toes on both feet and legs were cool to touch. He reports discoloration resolved but developed worsening bilateral lower extremity edema. Imaging revealed extensive deep vein thrombosis in left lower extremity requiring treatment and thrombectomy. The patient underwent lab tests and procedures which included sars-cov-2 antibody test: negative on 07Apr2021, and sars-cov-2 antibody test (nasal swab): negative on 13Apr2021. Treatment was received for the events. The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization (Apr2021). Outcome of the events was recovering. Information on the lot number has been requested.

BRIEF OVERVIEW: Bilateral PE Discharge Provider: MD Primary Care Provider at Discharge: NP Admission Date: 4/26/2021 Discharge Date: 4/26/2021 Active Hospital Problems (Diagnosis Date Noted) ? Pulmonary embolism without acute cor pulmonale, unspecified chronicity, unspecified pulmonary embolism type (HCC) 04/26/2021 Resolved Hospital Problems No resolved problems to display. CONSULTS: None INPATIENT PROCEDURES: None DETAILS OF HOSPITAL STAY: Patient is a 51 y.o. male with a past medical history of psoriasis, environmental allergies who presents today with sudden shortness of breath, left side pleuritic chest pain 7/10, worsened with deep inspiration. No recent travel, no family history, no history of malignancies, no immobilization or surgeries. He had his 2nd dose of Pfizer COVID vaccine on April 1. He does not have a history of COVID-19 infection, and COVID-19 PCR test was negative in ER. His blood pressure is a little high at 170 6/83 mm, pulse 76 per minute saturating 96% on room air, troponin less than 6, BNP 16, WBC 12.3,, EKG without any significant ST T-wave changes. CT angiogram of the chest shows nonocclusive thrombi in almost all the lobes, there is no saddle embolus noted. There is no evidence of right heart strain. Echo: The technical quality of the exam was limited due to suboptimal acoustic windows. The left ventricle is normal in size. There is normal left ventricular wall thickness. The left ventricular ejection fraction is 60%. Regional wall motion abnormalities cannot be excluded due to limited visualization. The right ventricular size, thickness, and function are normal. No significant valvular pathology identified with Doppler examination. There was insufficient tricuspid regurgitation envelope detected to calculate right ventricular systolic pressure. Injection of contrast documented no interatrial shunt. There is no comparison study available. He was started on Heparin gtt. And admitted for observation. He required no supplemental oxygen. He was discharged later pm on Eliquis 10 mg bid for 7 days, than 5 mg bid for 3 months. I am questioning did he had COVID-19 vaccine related bilateral PE. His hypercoagulable profile is pending. He has no sign of malignancy, no new symptoms, no weight loss. He had normal colonoscopy 2 yrs ago. He should follow up with his PCP. He was given work excuse from 4/26-5/3/21. She shouldn't take non steroidal anti-inflammatory (Ibuprofen (Motrin), Naproxen, Naprosyn, Voltaren, Relafen ... meds because of blood thinner Eliquis. He can take Tylenol 500 mg 1-2 tabs 3-4x a day as needed. He was also prescribed Lidoderm patch. For HTN he was started on DASH diet and Norvasc 5 mg daily. He should follow up with PCP next week. Also he was instructed to quit smoking.

Patient reports swollen glands, blisters inside nose and mouth, achy body, and pain similar to his past shingle infections. Patient believes he is now having an outbreak of shingles. Patient also reports feeling overall very weak 48 hours after the vaccine.

Within a day of 2nd Pfizer dose (intramuscular, left shoulder) had flu-like symptoms (aching joints, tired, chills, swelling under jawline, metallic taste in mouth) but they disappeared by third day from date of vaccination. By the 10th day after vaccination had developed intense shoulder pain radiating from shoulder to mid-arm (left arm) and upper back (trapezius/neck). Went to local Urgent Care next day and was X-rayed and given the following: Methylprednisolone - 4MG (tapered dosage) ? Shoulder/trapezius muscle pain/inflammation Cyclobenzaprine - 10MG ? Muscle relaxant for shoulder/trapezius muscle pain/inflammation. By end of tapered does still feeling intense ache/throb and pain in same areas.

Pt had localized swelling induration warmth and lymphadenopathy he thought he had a fever but did not check

ED to Hosp-Admission Discharged 2/23/2021 - 2/25/2021 (2 days) Treatment team Costochondritis Principal problem Discharge Summary (Physician Assistant) ? ? Internal Medicine Cosigned by: MD at 2/27/2021 4:06 PM Discharge Summary Hospitalist Medicine Admission Date: 2/23/2021 Length of Stay: 0 Days Discharge Date: 2/25/2021 Admission Diagnosis Hospital Problems POA * (Principal) Costochondritis Yes COVID-19 Yes Problem List Resolved POA Resolved Problems Atypical chest pain 2/25/2021 Yes SIRS (systemic inflammatory response syndrome) (CMS/HCC) 2/25/2021 Yes Hyponatremia 2/25/2021 Yes Dehydration 2/25/2021 Yes Home Or Self Care CODE STATUS: Full Code Active Issues Requiring Follow-up Test Results Pending at Discharge Pending Labs Order Current Status Blood culture x 2 SETS Preliminary result Blood culture x 2 SETS Preliminary result Hospital Course Hospital Course: Please refer to the admitting providers H&P for full history. Patient is a 51-year-old male with a PMHx significant for hemochromatosis, sarcoidosis and morbid obesity who initially presented to the ED for evaluation of chest pain, cough and shortness of breath. On presentation, vitals were mostly unremarkable other than some mild tachycardia and tachypnea. Patient was able to maintain adequate oxygenation on room air but was placed on supplemental oxygen for comfort. Blood work was mostly unremarkable. ABG was not particularly concerning. Troponin was negative x3. Patient underwent chest CTA which showed basilar atelectasis bilaterally and scattered groundglass opacities and scattered borderline size hilar and mediastinal lymph nodes consistent with patient's known sarcoidosis. Patient was treated with supportive care and monitored overnight. He was able to maintain sufficient oxygen levels. On the time my evaluation, patient continues to complain of bilateral rib pain worse with deep breaths consistent with costochondritis. I discussed with the patient that he will need to continue to take NSAIDs on a scheduled basis to help with his discomfort. Additionally I offered to prescribe cough medicine. I discussed possibly discharging the patient on steroids however he states that he makes a point to avoid taking steroids due to his history of hemochromatosis. At this point, patient no longer requires care in the hospital and can be discharged home. Patient is agreeable with the plan and all questions have been answered appropriately.

Patient underarm was inflamed. There is a noticeable swelling under the armpits. Patient was vaccinated in the Deltoid muscle of the right arm.

4/14/2021 I received 2nd Pfizer at 8 am, but around 10 am I started to feel my left leg tighten up. In two days I could not walk. They tried to give me muscle relaxants and pain meds. But It did not cure anything. I have had a low-grade temperature(usually exactly 99.5 but sometimes higher ) for 38 days and does not go away. I felt inflammation and at the hospital, they did a C-Reactive Protein (CRP) and it showed 144 mg/L. I entered the hospital from 5/21/2021 till 5/25/2021. They ran many tests but found no infections. They did possibly find some preexisting condition that I might have had all along. The only problem I have is I was completely healthy per se (even with the preexisting condition that I didn?t know about) right before the vaccine I was able to exercise, able to lift weights, good energy level, and eating properly. I feel like the vaccine is still somehow working in my body even that is not supposed to be the case. I feel like my body is still in a state of hyper inflammation and it killing me.

allergic reaction to the Covid 19 vaccine; nerves in his right wrist are bothering him, feels the nerves moving up and down and his arms, and feeling like the nerves in his right arm were jumping; right hand won't relax, can't bend the fingers on his right hand, can't make a fist with his right hand; like he has no control of his arm; right wrist feels like needles and pins; right hand blew up with inflammation; His fingers on his right hand were swollen, right hand looked like it was going to explode; Like his right arm was agitated, right arm was still very uncomfortable; pain in his hand; This is a spontaneous report from a contactable consumer (patient). A 52-year-old male patient received the second dose of BNT162B2 (PFIZER COVID-19 VACCINE, lot number: EW0164), at the age of 51 years old, in right arm at single dose on 23Apr2021 16:30 for covid-19 immunization. Medical history included sleep apnea, congestive heart failure, high blood pressure and type 2 diabetes, seasonal allergy and covid-19 in May2020. The patient reported he had symptoms of the covid-19 virus in May2020. He had a positive covid-19 virus test and did quarantine. The patient reported he's never been allergic to any kind of medication. Concomitant medications included atenolol 50-25 mg at one tablet a day. The patient didn't know the name of the other medication combined with the atenolol. The patient reported one was for the heart and one was for the blood. He also took medication for seasonal allergies but declined to provide the name. The patient previously received a flu vaccine (NDC/Lot/Expiry: unknown) on 2020 that made him feel bad with a head cold. The patient previously received the first dose of BNT162B2 (lot number: EP7534), at the age of 51 years old, in right arm at single dose on 02Apr2021 16:30 for covid-19 immunization. The patient started having some problems maybe a week after that. He started feeling like the nerves in his right arm were jumping. Like his right arm was agitated. His finger on his right hand were swollen. The patient did get his vaccine in the right arm. He thought his arm was going to bother him after he got the vaccine. The nerves in his right wrist are bothering him. Like he felt the nerves moving up and down and his arms, like he had no control of his arm. His right hand blew up with inflammation. His right hand looked like it was going to explode. His right hand won't relax. On 01May2021 was when he noticed his arm acting funny. He would say that the swelling had gone down from taking the antibiotics but his right arm was still very uncomfortable and he couldn't bend the fingers on his right hand and he couldn't make a fist with his right hand. His right wrist felt like needle and pins. The patient went to the emergency room at a hospital two nights in a row on 04May2021 and 05May2021. The first time he had x-rays done. The second time he had x-rays and a sonogram of his right arm to check for blood clots and he had some blood work done. All of that came back negative. The emergency room doctor asked him what arm did receive BNT162B2 in, he told the doctor his right arm, the doctor told him he's having an allergic reaction to BNT162B2. The emergency room doctor prescribed him an antibiotic to take. He'd already finished the antibiotic and didn't recall the name, the bottle had been thrown away. The patient followed up with his primary care doctor on 13May2021 and was given a prescription for a muscle relaxer and motrin 600 mg to help bring the swelling and pain down in his hand. In the emergency department he had a right arm and right wrist x-ray. The doctor was trying to figure out why his right hand looked like a balloon. The only conclusion the emergency room doctor came up with was that he was having a reaction to BNT162B2. The outcome of events nerve in wrist bothering, felt nerve moving, feeling nerves jumping, right arm agitated, no control of arm, right hand won't relax and couldn't bend fingers was not recovered. The outcome of events hand blew up with inflammation, fingers on right hand swollen, right hand explode and pain in hand was recovering. The outcome of events wrist felt like needles and pins and allergic reaction to vaccine was unknown. No follow-up attempts are needed. No further information is expected.

Patient presented to pharmacy on 5/29/21 with cold sore/blisters around mouth. Lips were also noticeably red. Patient was seeking treatment for Valacyclovir/Acyclovir from pharmacy. Patient says the blisters occurred after he got the vaccination. Instructed patient to see PCP or if urgently needed to go to the emergency room.

Left armpit is swollen and tender; Left armpit is swollen and tender; Is the same side as the injection; Typical soreness where the shot was; This is a spontaneous report received from a contactable consumer or other non hcp. A 51-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch number: ER8731 and Expiry date: Unknown), via an unspecified route of administration, on 24May2021 13:00 as 1st dose, single dose on left arm for Covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient had the shot on typical soreness where the shot and Is the same side as the injection has not really had any side effects until this morning. On the same date he got the shot he had some tenderness at the site. The patient experienced left armpit is swollen and tender and is the same side as the injection on 27May2021. The events assessed as non-serious. The patient initially stated this was subsided, but clarified it was still ongoing even though he initially said he had no side effects until today as well. If he touches it, it was still tender. Outcome of the events Is the same side as the injection and Typical soreness where the shot was resolving while outcome of the remaining events was unknown. Information on Lot/Batch number is available; Further information has been requested

axillary lymphadenopathy/Lymphadenopathy was evident in the left axilla/large lymph nodes; full blown flu like syndrome with headache, body ache and flu like chills, nasal drainage and eyes watery/ congested, nose running like a faucet non stop; sore throat; severe right deltoid pain; arm very tender and swollen; fees like crap and is hard to get out of bed every morning; rhinitic, congested, draining like a faucet; severe pain in left foot and right hand; Has been fatigued and his body aches and he is exhausted.; He couldn't even walk, it was completely painful.; This is a spontaneous report from a contactable physician (patient). A 51-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 04May2021 (at age of 51 years old) (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunisation. Medical history included flu, has gotten the flu before but has never gone on this long. The patient's concomitant medications were not reported. Clinical course as reported: He is a practicing physician who has been providing vaccinations to patients all of his life. He ended up with severe right deltoid pain. It is usually not a problem, he has dealt with this with other shots. By the second or third day, it was very tender and swollen and had axillary lymphadenopathy on the same side he re-ceived the vaccination. It persisted the next day until day 5 or 6. He then started to get worried. He went to the hospital. They did a CT scan which noted there was notable lymphadenopathy. They thought it was a reaction to the Covid vaccination. 2 days later, he went home and he kept taking Motrin and Tylenol on board. Lymphadenopathy was evident in the left axilla, inguinal nodes, and is still there now. On day 7, he went into full blown flu syndrome, had a headache, body aches and flu like chills, the whole thing. Is still a little bit rhinitic and is very congested, and is draining like a faucet. It has all been happening since he got vaccinated. He was told he was either exposed to covid or it is from the vaccination. He went to urgent care yesterday (20May2021) and they did a Covid test which was negative. He hates to point fingers but this fatigue has been overwhelming and is never ending. He called withheld where he got the vaccination. He said the pharmacist has been hearing this from a lot of patients. He reported for 7 days straight the clinical events as they were happening. Nobody has contacted him, they said some-one would be contacting him the next day and he has not heard from anyone. This laid him up for 5 days. The last 4 days, he had severe pain in the left foot, and the right hand. It was out of the blue like someone whacked him with a hammer. He couldn't even walk, it was completely painful. He hasn't worked out since he got the damn shot. In 15 days, he has not gone to the gym. They did an X-ray which didn't say anything. He was in immense pain. They gave him prescription for Prednisone 50mg and he hasn't been able to get to the pharmacy to get it yet but will head over shortly. Has been taking Motrin and Tylenol around the clock. Has been taking antihistamines because his nose has been running like a faucet non stop and he has a sore throat. Sore throat has gotten better in the last 5 days. The pain was really bad. The sore throat has subsided. The nasal drain-age and his eyes are watery are still there. Has been fatigued and his body aches and he is exhausted. The second vaccination is due 25May2021 and he is absolutely not getting the second one. When having other viral syndromes, he has never felt this sick. Has gotten the flu before but has never gone on this long. He is just feeling like crap. Can barely even get out of bed every morning. It is unbelievable. He hasn't had any true positive exposure. Has not been exposed to other family members with Covid/ coronavirus. Have practices strict isolation in their home. They have 5 kids and they did not go near anyone or go to any public places. For this to happen, it has to be because of the vaccine. Nothing else could have caused this. No one else around him has been sick. Is not sure if they are getting a lot of reports. When going on line to the Pfizer vaccine reporting, it took him a while to get a number to contact Pfizer directly. He called (Withheld) and they gave him 2 wrong numbers. It took 4 people to get the number to report this to Pfizer. He thinks there is a lot of under reporting. If he has a deductible, he would like Pfizer to take care of the cost for his ER visit. On 21May2021, reported that Beginning 05/04 when received vaccine, experienced Very large lymph nodes and Flu syndrome. Outcome for events sore throat was recovered on May2021, for other events was unknown. The lot/batch number has been requested.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded The impact of this report on the benefit/risk profile of the Pfizer drug 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.

Peripheral Edema (calves, ankles, and upper feet) within 24 hours after injection. Persistent but declining over the course of three weeks, until the 2nd dose. A repeat of the above occurred within 24 hours of the 2nd dose, same results.

He also reports his right leg and foot started swelling; He also reports his right leg and foot started swelling; Sweating; feels weird; Shaking; Later that day he states his left arm (injection arm) started twitching; he vomited; and his left pinky and ring fingers were numb; right leg blew up; This is a spontaneous report from a contactable consumer (patient). A 51-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot/Batch number: EW0181), via an unspecified route of administration in left arm on 28May2021 as single dose for covid-19 immunization. The patient's medical history included alcohol use stated that all he does was drink some liquor and beer. No medications or surgeries. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Patient stated that after he received his first Pfizer COVID-19 vaccine dose on 28May2021, later that day he states his left arm (injection arm) started twitching, he vomited, and his left pinky and ring fingers were numb, and the patient felt nervous like he was shaking. On 14Jun2021, the patient also stated that he got the shot and the band aid that they cover the injection area with, it was branded in his arm and he got the shot 3 weeks ago and it looks like a band aid is on his arm. He thought it would be gone and it stayed. On an unknown date, the patient reported that his right leg and foot started swelling. The patient's right leg blew up. He reports the band aid to his injection site looks like it "burned" into his arm. He states his right/foot leg swelling and left arm twitching have continued and wants to know if this is a reported side effect. Now after he got the shot his arm has been twitching, he's sweating and vomiting all morning. His right leg blew up and he feels weird. He just doesn't feel like himself. Right after the shot, the patient felt like there's a bunch of fluid. It's ongoing, it has gone down a little bit. It's improved a little, very irritating when it does happen. He can't eat. It won't stay in his stomach and he can't hold water. It has improved but when it happens, he feels terrible. There was no emergency or physician room visit for the events. The clinical outcome for the events was unknown, the other events muscle twitching, and shaking was not recovered. Information on Lot/Batch number was available. Additional information has been requested.

After second dose, had the typical feeling like the flu, but lymph nodes were swollen. The flu symptoms passed, but continued to have problems with lymph nodes. Fatigue set in just after flu symptoms, have never recovered. In June, I started having pain in my upper maxillary. Saw my dentist, who sent me to a dental surgeon. They determined that it was wire from a jaw surgery 30 years ago. They removed the wire, but all of the other wires are giving me pain, and may need to be removed. They had not bothered me prior to the vaccine. Mental health has also declined and not recovered. My medications are now higher than pre vaccine. Fatigue is still a major problem.

On 06/03/21, developed swelling following COVID-19 Pfizer Vaccine and developed VTE L IJ and subclavian vein

Hands Hurt; Swollen Hands/Arms itching, swollen, and red; hives are under his chest, groin, and all over now, but not on his face; itching on his hands like crazy, like he wanted to take his skin off; Arms itching, swollen, and red; This is a spontaneous report from a contactable consumer. A 51-years-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Lot Number and expiry date was not reported) via an unspecified route of administration on 23Apr2021 as a single dose for covid-19 immunisation. Medical history included ongoing splenectomy which was continuing. The patient's concomitant medications were not reported. Historical vaccine included BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection) on 02APR2021 for covid-19 immunisation. On 29Apr2021 20:00 patient experienced swollen hands with, hives are under his chest, groin, and all over now, but not on his face, itching on his hands like crazy, like he wanted to take his skin off, hands hurt, arms itching, swollen, and red, arms itching, swollen, and red, arms itching, swollen, and red. Therapeutic measures were taken(Benadryl three times a day) as a result of swollen hands, hives are under his chest, groin, and all over now, but not on his face, itching on his hands like crazy, like he wanted to take his skin off, hands hurt, arms itching, swollen, and red, arms itching, swollen, and red , arms itching, swollen, and red. Patient did not visited emergency room/physician office due to events. Outcome of the events was recovering. Information on the lot/batch number has been requested. Follow-up (21Jun2021): Follow-up attempts completed. No further information expected.

Household contacts had covid 4/15/21 (PCR+) when pt had cough/fatigue. He got 1st Pfizer dose 5/11/21. 5/24 he develops abdl pain, nausea, vomitting; seen in ED 5/28 w/ WBC cnt 17k CRP 197 but neg CT abdomen. Our ED on 5/31—hypotensive, temp 101.8, pulse 130s, COVID PCR neg, CXR normal. Despite fluids, needed pressors. Next day, still on pressors, new CHF, pulmonary opacities on XR, Echo with severe biventricular hypokinesis(EF 20%). Inflamm markers elevated: WBC 19k , 92% polys, hgb 11, plts 73k, CRP 334 mg/L, COVID spike Ab 1568, COVID NP index 233. Rx with IVIg for MIS x 1 dose, steroids, rapidly improved. On 6/11, 6/24 EF 60%, inflamm markers, CBC normalized. Now well, off steroids. MIS likely due to vac

Swollen face; severe head and body aches; severe head and body aches; fever; chills; muscle weakness; joint pain; This is a spontaneous report received from a contactable consumer (patient). A 51-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EP7534), via unspecified route of administration in left arm on 19Mar2021 12:15 PM (at the age of 51-year-old) as dose 1, single for COVID-19 immunisation. The patient's medical history included anxiety and depression from unspecified date. It was unknown if patient was diagnosed with COVID-19 prior to vaccination. The patient's concomitant medications received within 2 weeks of vaccination included escitalopram oxalate (LEXAPRO) 20 mg, losartan 50 mg, fish oil and beet root, all from unspecified date. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took niacin and he experienced allergy. On 21Mar2021 05:00 AM the patient experienced swollen face, severe head and body aches, fever, chills, muscle weakness and joint pain. Fever and swollen face only occurred for 24 hours (22Mar2021). All other symptoms persisted for 6 days (27Mar2021). The case was reported as non-serious. The events resulted in emergency room (ER)/department or urgent care. Treatment received due to the events included ER visit on 25Mar2021, intravenous (IV) (as reported) and Zofran was given. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was resolved on 22Mar2021 for swollen face and fever and on 22Mar2021 and resolved on 27Mar2021 for all other events.

runny nose; Lymph nodes in my left armpit are sore; diastolic blood pressure has gone up and it is now mostly around 100, and systolic ranges from 130 to 160; diastolic blood pressure has gone up and it is now mostly around 100, and systolic ranges from 130 to 160; I have been generally not feeling well compared to before the vaccination; cough; head congestion; This is a spontaneous report from a contactable consumer. This consumer (patient) reported for himself that a 51-years-old male patient received first dose of BNT162B2 (Pfizer-Biontech COVID-19 Vaccine, solution for injection, batch/lot number: 59267-1000-01/EW0161), via an unspecified route of administration in left arm on 19Apr2021 12:00 (at the age of 51-years-old) as single dose for COVID-19 immunisation at pharmacy or drug store. The patient's medical history and concomitant medications were not reported. The patient neither received other vaccine in four weeks nor other medications in two weeks. He had no known allergies. It was unknown if covid prior vaccination. Not tested covid post vaccination. It was unknown, if the patient was diagnosed with COVID-19 prior to vaccination and since the vaccination, the patient had been not tested for COVID-19. The device date was 02May2021. On 19Apr2021 12:00, the patient experiencing some health issues after taking the first dose of the Pfizer COVID-19 vaccine. Not sure if he should go for the second dose scheduled for 10May21. He took the first dose on 19Apr2021, since 19Apr2021 12:00 (then) he had been generally not feeling well compared to before the vaccination, did experience cough, head congestion, and runny nose. On 19-APR-2021 12:00, lymph nodes in his left armpit were sore, he was vaccinated in the left arm. It was getting better but not his normal self. Typically, when he was physically active his blood pressure stayed under control, but he noticed that his diastolic blood pressure had gone up and it was now mostly around 100, and systolic ranges from 130 to 160 (start date: 19-APR-2021 12:00) whenever he took readings at home after the vaccination. The patent had started taking AMLODIPINE 2.5MG tablet since 01May2021 but it was not helping much (corrective for blood pressure up). No treatment for all other events. The outcome for all the adverse events was unknown. No follow-up attempts are needed. No further information is expected.

Injection site pain; Swollen and tender left armpit lymph nodes; This is a spontaneous report from a contactable consumer, the patient. A 51-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: PAA165969), via unspecified route of administration in the left arm at 15:30 on 22Mar2021 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported and the patient had no known allergies. The concomitant medications were reported as no. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. On 26Mar2021, the patient experienced injection site pain, swollen and tender left armpit lymph nodes. The patient did not receive treatment for the reported events and the events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of events injection site pain, swollen and tender left armpit lymph nodes was not resolved at the time of this report. No follow-up attempts are needed. No further information is expected.

swelling in the lymph nodes in my right arm pit; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old adult male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA vaccine; Lot Number: Er2613) via an unspecified route of administration in the arm right on 29Mar2021 at 16:45 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. Concomitant medications were not reported. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 31Mar2021 at 06:00 the patient experienced swelling in the lymph nodes in right arm pit. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the adverse event. The clinical outcome of swelling in the lymph nodes in right arm pit was unknown at the time of this report. No follow-up attempts are needed. No further information is expected.

LEFT SIDE OF FACE WASSWOLLEN; Headache; Pain; LEFT EYELID DIAGNOSED WITH BLEPHARITIS; GUM AND TEETH PAIN.; GUM AND TEETH PAIN.; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EP6955), in the right arm on 22Mar2021 at 10:30 (at the age 0f 51-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history. The patient did not have allergies to medications, food, or other products. The patient did not receive any other medications within 2 weeks of vaccination. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 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 23Mar2021 at 18:00, the patient experienced face swelling on left side with headache and pain and also diagnosed with blepharitis in left eyelid. The patient had also experienced swelling in upper eyelid and itchy and also gum and teeth pain. The events resulted in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. Therapeutic measures were taken as result of events which included antibiotics and ointment for both eyes. The clinical outcome of the events left side of face swollen, headache, pain, left eyelid diagnosed with blepharitis, gum and teeth pain was resolving at the time of this report. No follow-up attempts are needed. No further information is expected.

Expected symptoms ended within about 24 hours from the shot. But 48 hours after the shot there was massive nerve pain in the (left) shoulder of the shot, the pain radiated throughout deltoid, chest, shoulder, neck on the left side. This nerve pain lasted for about 36 hours and then dissipated (I know it was nerve pain because years ago i experienced something similar in the other shoulder for unrelated reasons). But the shoulder was very sore and weak for 2 full weeks, during which i saw an orthopedist who diagnosed bursitis caused by SIRVA. For weeks afterwards the shoulder felt like it returned to normal . However in the first 2 weeks of June my whole left arm began getting sore and tired. In midjune i noticed that my shoulder was atrophying and the front deltoid was not activating (my biceps was doing all the work). Orthopedist ordered an EMG (June 29), which confirmed axillary nerve damage to anterior deltoid. I?ve been doing physical therapy since mid June and as of today July 25th it is beginning to recover but it could take months to a year and may never fully recover.

Swollen under left armpit that irradiates to my arm, L+ right side of my chest and L+ neck side. It caused pain and discomfort since last night.

Headache, Myalgia, Arthralgia, Angioedema, Nausea Vomiting & HYPOtension Narrative: Extensive >4 days symptoms, lost work time

Fatigue; lymph node swelling; This is a spontaneous report from a contactable nurse. A 52-year-old male patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown) intramuscular from 06Jan2021 10:45 to 06Jan2021 10:45 at single dose for COVID-19 vaccination. Medical history included idiopathic epilepsy. Concomitant medication included carbamazepine. On 06Jan2021 at 17:00, the patient had fatigue two days after as well lymph node swelling in armpit of arm where second dose administered. The patient also stated that with first dose from 15Dec2020 to 15Dec2020 for COVID-19 vaccination, the patient had soreness in his arm with no other symptoms. Outcome of the events was not recovered. Information on the lot/ batch number has been requested.

Extensive periorbital and midface Facial swelling associated with the site of prior dermal fillers (Restylane) placed about 6 months prior

EE woke up on 12/22/2020 experiencing diarrhea, facial flushing and swelling, lip/brow swelling, hands started swelling, edema, redness/rash. Patient was evaluated at local EC and was found to have low BP. EE was treated with Solumedrol, Benadryl, and Pepcid. Patient was discharged home from EC after 2 hours with PO steroids x4 days.

Within 48 hours of receiving the second vaccine I developed severe pain in my left chest wall and arm which was unrelieved with NSAIDS. I also noted left axillary lymphadenopathy. I made an appointment with my pcp who ordered a CT scan

generalized itching, maculopapular rash, lips, face, neck, tongue swelling, difficulty of swallowing, left wrist swelling, generalized weakness, fatigue. 2nd dose of vaccine received on 01/11/21, first was on 12/22/20. Symptoms started on 01/16/21 between 1 and 2 am. First day symptoms were mild resolved after taking allegra and benadryl. On 01/17/21 between 2 and 3 am started again, and got worse, did not improve after taking allerga and zyrtec. Later in the day started on prednisone daily, allegra daily and one dose of benadryl. Symptoms lasted for few more days

Starting the day after the injection he began experiencing arm swelling, stomach cramps and brain fog. He saw his PCP who recommended Benedryl.

Swelling in right armpit. Edemas to about the size of half an orange. Was consistent with a hematoma instead of glandular swelling. Swelling spread out throughout the entire left side over the week until it dissipated. I did take pictures and have them available if so desired.

52-year-old male reports developing multiple HSV simplex lesions around his upper lips within 24 hours of receiving the second Covid 19 vaccine. Patient has had HSV-1 lesions before but never to this extent; patient is otherwise stable and afebrile. He has no radicular pain. Labs are ordered for CBC and a CMP. The vaccine support center was called at approximately 3:35 PM and message left. The vaccine support center was called again on February 26, 2021 at approximately 9:20 AM. Provider spoke with NP for consultation. VAERS CDC report advised. No further action required. Antiviral medication was not offered due to the fact that patient was on day 6 post outbreak and out of the window of opportunity to treat acutely.

Severe aches and pains in every joint. Started the morning after (8:00am), started to abate late afternoon, pain let up early evening, fine by 10:00pm. Took Tylenol. Sunday developed a swollen lymph node in left armpit - about the size of a golf ball. Painful to touch/sleep for 2 days. Lasted approx 10 days. Did nothing, went away on its own.

Twelve hours after first vaccine dose, experienced mild facial swelling, numbness. Resolved 6 hours later without intervention.

within two hours of the second dose, the patient experienced red skin in face and hands, muscle aches and fatigue. After four hours the patient experienced swollen lymph nodes. Although his lymph nodes were swollen on his left and right side, the lymph nodes on the patients left side (same side as the injection) were more swollen and sensitive to the touch. The next day, joint pain and muscle fatigue persisted, the patients also experiences chills and small blemishes on his face and left arm. On the night of 13 March 2021, patients experienced fever of approximately 99.5 degrees Fahrenheit (F). After taking 1000mg of Acetaminophen, the fever was reduced to 89.9 F. Two hours later, patent's temperature rose to 101.5 F. Patent then took 800mg of Ibuprofen. This brought the patient's temperature down to 99.5. Then he went to sleep. The next day 14 March, the patent experienced a sore throat and higher fever. He went to the urgent Clinic for examination.

white blood cell count was very high; death; This is a spontaneous report from a contactable consumer (ex-spouse) via medical information team. A 52-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 on 02Mar2021 at a single dose (at the age of 52-years-old) for COVID-19 immunisation. Medical history included back pain: At some point before the vaccine was administered, he had a telehealth visit for reported back pain. Concomitant medications were not reported. The patient died on 05Mar2021 at his home. The patient received the first dose of COVID vaccine at a hospital on 02Mar2021. The patient was a fairly healthy active 52-year-old. At some point before the vaccine was administered, he had a telehealth visit for reported back pain. He was instructed to get blood work/labs done. A letter was received the day of his death that states his white blood cell count was very high and with it a recommendation that he seek medical attention. She (ex-spouse) reports the autopsy results won't be complete for a few months. The cause of death is unknown. The outcome of white blood cell count was very high was unknown. Information on the lot/ batch number has been requested.; Reported Cause(s) of Death: Death

Legs started itching after 1 day Arms and body started itching day 2 Lymph nodes starting swelling day 2 Itching still remains as does the swollen lymph nodes

Pain at injection site expanded to joints and muscles in all parts of the body. Mild sense of swelling in arms and legs and face, numbness and tingling in extremities. Slight tightness in chest.

On the day after shot, starting at 2am, I ran a fever of 100.3. Headache, soreness, and really tired. Tylenol seemed to keep symptoms at bay, but felt very lethargic, and needed to sleep. By day 2, fever had diminished. But had swollen lymph nodes (lymphodemenopothy) in left arm pit.

Systemic: Allergic: Anaphylaxis-Mild, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Additional Details: Patient had shortness of breath, chest tightness and throat swelling (uncomfortable feeling described by patient). Paramedics took the patient with them. Patient came to the pharmacy 3 hrs later and informed us that he was doing okay and his breathing was better.

arm pain; Also reports joint stiffness around neck and shoulder; Lymphadenopathy-Lymph Node Pain/tenderness on right side- near the axilla, underneath the arm next to the chest; Lymphadenopathy-Lymph node pain around left clavicle; Lymphadenopathy-Lymph node pain around left clavicle; This is a spontaneous report received from a contactable pharmacist (patient himself). A 52-year-old male patient received first dose of BNT162B2 (Solution for injection, Lot Number: EN6205, Expiry date: Jun2021), via intramuscularly to the left arm on 26Feb2021 at single dose for COVID-19 immunization. The patient medical history included Hypertriglyceridaemia ongoing. Concomitant medication included Fenofibrate. The patient previous vaccination included Shingrix used for shingles and experienced with sore arm. The patient lab test included Sar-cov-2 which was negative. Patient reported that he received his first dose of the Pfizer BioNTech covid vaccine on 26Feb2021. He is due for his second dose this Friday 19Mar2021. He is calling because he experienced lymphadenopathy- explains he experienced Lymph node pain/tenderness around his left clavicle. Caller clarified that the injection was on his left side. The pain/tenderness occurred the next day, 27Feb2021 and it was self limiting and it lasted about 5-7 days. He didn't think anything of it, everything else was ok, the arm pain resolved after one day. On 12Mar2021, he developed similar pain on the right side, but it was a more intense pain/tenderness and lasted maybe 4 days. He still experiences it, but less frequently. He is not sure if he is describing it correctly. During the afternoon, it gets a bit more tender. He doesn't feel it in the morning, but by the afternoon he notices the pain/tenderness. He did not know if there were any reports of contralateral lymphadenopathy (lymph node pain). He clarified that there is no redness or lump- he doesn't feel anything, even if he touches it there's no pain, but periodically there will be a shooting tenderness. He feels like it's getting better, but it is still persisting. He clarified that on the right side- he is experiencing pain near the axilla, underneath the arm next to the chest. He is waiting to see if it is improving and doesn't know how long he should wait. He stated that it wasn't that painful on the left side, it was just a little tender; he knew something was different. The pain wasn't always there. Sometimes there's a little pain on the left side still, but not as intense as the right side. The pain is there, it's not worsening but it is not improving. The patient also reports joint stiffness around neck and shoulder and describes discomfort as ongoing intermittent tenderness. The reporter reported events Lymphadenopathy-Lymph node pain around left clavicle, Lymphadenopathy-Lymph Node Pain/tenderness on right side- near the axilla, underneath the arm next to the chest to be serious due to Medically significant. The outcome of events was not recovered. No follow-up attempts needed. No further information expected.; Sender's Comments: Based on the available information, temporal association and known product profile, a possible causal relationship cannot be excluded between the suspect product BNT162B2 and the reported events Lymphadenopathy, Lymph node pain and Tenderness. 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 Day two injection site very sore. Day three I woke up to pain in my left arm pit area, upon inspection noticed a baseball sized swelling in arm pit.

anaphylactic shock Began with neck pain on left side, heavy dry mouth, profuse sweating, saw odd colors and dashboard of car coming at me in design, very cold and light headed, trouble breathing, throat felt swelled, bowels and bladder felt they were going to let loose. went unconscious, - after recovery I had tremors for a few hours such that I could not hold a glass of water, legs felt hot to the touch and ached for several days. Still feel weak and tired.

Swollen lymph node (in arm pit, same side as shot). Diarrhea. Fatigue. Muscle soreness. Mild fever (100F) w/ brain fog.

Patient reports a sensation of tingling at the site of his vaccine. He reported a sensation of swelling, but no swelling was noted on examination. The symptoms lasted about 15 minutes.

Swelling and redness in toes, painful above and below nail bed. Resulted in drying and scarring of skin on two toes.

tremors; legs felt hot; legs felt hot to the touch and ached; weak; tired; anaphylactic shock; went unconscious; neck pain; heavy dry mouth; profuse sweating; saw odd colors and dashboard of car coming at me in design; very cold; light headed; trouble breathing; throat felt swelled; bowels and bladder felt they were going to let loose; bowels and bladder felt they were going to let loose; This is a spontaneous report from a contactable consumer (patient). A 52-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration, administered in arm left on 02Apr2021 at 14:00 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history included known allergies (sometimes seafood and some fresh fruits) from an unknown date and unknown if ongoing. Concomitant medication included lisdexamfetamine mesilate (VYVANSE), lisinopril and lamotrigine (LAMICTAL), all taken for an unspecified indication, start and stop dates were not reported. The patient experienced anaphylactic shock which began with neck pain on left side, heavy dry mouth, profuse sweating, saw odd colors and dashboard of car coming at him in design, very cold and light headed, trouble breathing, throat felt swelled, bowels and bladder felt they were going to let loose. The patient then went unconscious. After recovery, the patient had tremors for a few hours such that he could not hold a glass of water, legs felt hot to the touch and ached for several days. Still feel weak and tired. Reaction began about 18 minutes (also reported as 14:15) after the shot. Therapeutic measures were taken as a result of all events. The outcome of the events was recovering. The events were assessed as serious and life-threatening by the regulatory authority. Information on the lot/batch number has been requested.

Within moments of injection experienced metallic taste in mouth that lasted several days. Day after vaccine experienced fever up to 100.5 (even with 400 mg ibuprofen every 6 hours) that lasted 18 hours. Substantial pain that traveled from shoulder down the left arm. Very large swelling of the lymph node in left arm pit three days after injection. (not recovered from this yet)

headache, body aches, very large swollen lymph nodes under arm (swelling is the size of my fist), racing heart

1) Lymph node swelling under my left arm. Discontinued using deodorant, swelling diminished after approx 3 days. 2) on 4/12 I had a nose bleed ... I don't recall ever having had one before. Some bruising has apeared on my right shin, and I don't recall hitting my shin. After noticing it Sunday 4/18, a second large bruise appeared Monday 4/19.

4 episodes of nausea/vomiting/diarrhea, then found by spouse with altered mental status and nonresponsive/snoring. Taken to Emergency department for stroke evaluation. Ruled out for stroke, intubated for airway protection and cerebral edema with meningeal enhancement observed on CTA. Admitted to ICU.

4/15 immediate post-injection reaction: "Patient evaluated for chest pain after vaccine. Patient with L sided chest pain and back pain immediately after vaccine. Patient had identical reaction after first dose. When patient was laid in bed and given oral hydration, pain resolved. Patient felt confident that this was anxiety as with his first vaccine. VS and exam WNL. 2 lead EKG showed NSR with no clear ST changes. Patient was returned home with wife as driver. " 4/16 reaction: patient contacted PCP with complaints of "Nausea, stomach ache, headache, injection site discomfort, fatigue, some diarrhea." Patient requested something for nausea. Provider prescribed ondansetron. 4/22: patient contacted PCP with complaints that since 2nd dose, he has felt "Fatigue and feet pain with swelling and intermittent numbness . Also since then has not been able to control CBG, in AMs >200, using medications as prescribed." PCP monitoring; no medication treatments.

4/5 - Trip to emergency room, fever 104 to 104.3, headache, backache, neckache (right side), chills, muscle aches, diarrhea, lethargic - first 3 days, then next 4 days - intermittent fever - low grade, muscle aches, very lethargic, and diarrhea. (7 or a few more in total) 4/20/21 - 2nd shot - 36 hours of low grade fever, 100 or less, headache, chills, muscle aches and diarrhea.

Lymph Node under left arm starts to itch/hurt/ left arm pit Lymph Node swollen/itchy, achy; Eyes swollen; some wheezing; tired; Lymph Node under left arm starts to itch/hurt/ left arm pit Lymph Node swollen/itchy, achy; Lymph Node under left arm starts to itch/hurt/ left arm pit Lymph Node swollen/itchy, achy; minor tightness in breathing; Sever chills; fever; extreme fatigue; headache; eye ache; This is a spontaneous report from a contactable consumer. A 52-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 on arm right on 27Jan2021 at single dose for COVID-19 immunization. The patient medical history included Chronic Kidney Disease Stage III, High Blood Pressure, Asthma from an unspecified date and allergies to Penicillin, Levoquin, Erythromycin, Clindamycin from an unspecified 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 Concomitant medications were not reported. Historical vaccines included patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EL3249), via an unspecified route of administration on arm right on 06Jan2021 at single dose for COVID-19 immunization. On 28Jan2021, the patient experienced Sever chills, fever, extreme fatigue, headache, eye ache and got cleared on the same day. On 03Feb Lymph Node under left arm starts to itch/hurt. On 07Feb Eyes swollen (right almost swollen shut); left arm pit Lymph Node swollen/itchy, achy; some wheezing; and tired. Since then: i) swelling in eyes reduces and then swells again, ii) lymph node under left arm still itchy/achy/swollen, iii) at times minor tightness in breathing; and iv) tired.The event resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Therapeutic measures were taken, and treatment included prednisone and EpiPen. The outcome of the events was reported as Not recovered. Follow up (15Feb2021): This follow up report contains no new medically significant safety information. Follow up (17Feb2021): This follow up report contains no new medically significant safety information.

A couple of lymph nodes swollen, one above the clavicle and another one closer to the neck, both on the left side; Touching them feels tender and a little pain; This is a spontaneous report received from a contactable consumer (patient). A 52-years-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 05Apr2021 09:00 AM (Batch/Lot Number: EP6955) as SINGLE DOSE for covid-19 immunisation. Medical history included Seasonal allergies due to pollen and dust mites from an unknown date and unknown if ongoing. Historical vaccine included first dose of BNT162B2 (lot number=Pfizer EL3247) at Left arm on 16Mar2021 for covid-19 immunization. The medication the patient received within 2 weeks of vaccination was Dulcera inhaler for seasonal allergies. The patient experienced a couple of lymph nodes swollen, one above the clavicle and another one closer to the neck, both on the left side on 05Apr2021 with outcome of recovering, touching them feels tender and a little pain on 05Apr2021 with outcome of recovering. The events was non-serious. Reported a couple of lymph nodes swollen, one above the clavicle and another one closer to the neck, both on the left side. Touching them feels tender and a little pain. After 3 days the swollen nodes seem to be fading. No treatment received. No covid prior vaccination. No covid tested post vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No follow-up attempts are needed. No further information is expected.

Side effects: light chills, strong headache (3 days, after now 9 days still coming back briefly), fever (37.8C), muscle pain, body joint pain for 3 days, left arm pain (3 days), sweating (2nd night), fatigue for ~2days, and most importantly: for over 9 days/nights swollen nymph knot under left arm, was as big as a full hand full (like a full bar of soap), has meanwhile improved daily, but I can still sense a small (wallnut size) under the arm now, 9 days after the shot. It's important to inform because the media and the doctors are not reporting how bad and lasting the side effects are and it is important to be transparent to patients what to expect, otherwise trust is eroded and people stop getting vaccinated.

Approximately 4 hours after the shot, my vace and head broke out in with what look like "in grown hairs". The next morning, 4/23, my lymph nodes on the side of my neck, and under the tip of my chin swelled up significantly. Still there... Then the headache started (4/23), and is still ongoing. This is accompanied with major body aches, a very low grade fever, and occasional chills. Today, 4/27 at approximately 6:30pm, I started puking. I'd rather roll the dice with Covid then get a second shot!!!!!!

I broke out in a rash ( chest - neck - arms - legs - back) with extreme itching; I broke out in a rash ( chest - neck - arms - legs - back) with extreme itching; Face was swollen (eyes - lips -ears); Face was swollen (eyes - lips -ears); Face was swollen (eyes - lips -ears); Face was swollen (eyes - lips -ears); This is a spontaneous report from a contactable consumer (patient). A 52-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 15Apr2021 10:00 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. There were no concomitant medications. Facility type vaccine was Pharmacy or Drug Store. There was no other vaccine in four weeks nor other medications in two weeks. The patient broke out in a rash (chest - neck - arms - legs - back) with extreme itching, face was swollen (eyes - lips - ears). Patient went to the hospital and was given IV drip with Benadryl - steroids for treatment. Patient was then sent home but the rash and itching still persist. He then went to my doctor and was given 2 shots of steroids and Prednisone 10mg. The events onset date was reported as 16Apr2021 16:00. The adverse events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Life threatening illness (immediate risk of death from the event). The outcome of events was recovering. Patient had no COVID prior vaccination nor tested COVID post vaccination. No known allergies. Information on the lot/ batch number has been requested.

First vaccine was 3/1/21. 3/2/21 had muscle & joint aches, weakness, low grade temp, swollen lymphoid under arm until 3/3/21. Second vaccine was 3/22/21. Had same symptoms only more severe & higher temp. This time I was sick 4 days & unable to work. I was not better until 3/26/21

fever, chills, joint and muscle aches, night sweats, fatigue, lightheadedness, foggy headedness, - 3 days in a row starting April 8 then subsided and started again a few days later

Swollen red left arm. Diagnosed with blood clots in all his veins in left arm and spent 4 days in hospital on blood thinners and had 2 surgeries to remove them

pt woke up Friday morning (after having had vaccine on Wednesday evening) with R calf pain and swelling. He was sent to ER, where he was diagnosed with DVT

New onset peripheral edema, found to have pericarditis and bilateral pleural effusions without apparent underlying cardiac pathology, infection, or malignancy. Inflammatory markers also elevated.

- fever and chills during overnight hours the past 2 nights after shot, unable to sleep for more than an hour at a time. - headache most of the day on Sunday, headache area more so on top of head and some tingling in head at times. - worse chills overnight the 2nd night, had to change pajamas due to chills and sweating 2nd night. - 2nd shot given in left arm, 2 mornings later (Monday), excessive swelling in left armpit and pec muscle, swelling almost size of baseball and protruding, no bruising or pain, just very tender and uncomfortable, feels tight and can certainly feel skin stretched due to swelling.

Began with 7 hours of deep chills, fevers beginning 10 hrs after shot. Strange metallic smell in nose for one hour. Some tender mild swelling of lymph nodes for next 10 hrs, headache persisted 6hrs, , then mild congestion for 24 hrs. Malaise persisted throughout 24 hours even with bed rest.

On 11/08/20 the client had symptoms of fever up to 103.5 F, chills tachycardia 117 bpm, O2Sat nadir of 85%, respiratory rate 22, development of hypotension with BP 85/55 bpm with weakness, drowsiness, chills, flushed skin, bilateral edema both lower extremities with wheezing and rhonchi throughout both lungs and was sent to a local medical hospital for treatment where he tested positive for COVID and was returned to the psychiatric hospital after a 3 day stay and 2 administrations of remdesivir on 11/09/20 and 11/10/20 improved. The client subsequently received the Pfizer COVID19 vaccinations on 12/29/20 and 01/19/21 from different lot numbers noted above. On 5/16/21 the client began to have respiratory symptoms including temp of 99.5, pulse 103 O2 Sat of 85% with rhonchi responsive to albuterol inhalation and subsequently albuterol nebulizer treatment; however the following day symptoms progressed with weakness, wheezing, cough, shortness of breath, pallor and O2 saturation 77% unresponsive to albuterol nebulizer treatment. He was was transferred to a local medical hospital for treatment of severe respiratory symptoms and tested positive for COVID a second time and after the complete Pfizer COVID19 vaccination series approximately 4 months prior. He is still hospitalized at the medical hospital at the time of this report (2 days).

Clinical Support 3/31/2021. Exposure to SARS-associated coronavirus +1 more. Dx Labs Only. Reason for Visit ED Discharged 4/30/2021 (2 hours) Treatment team. Providers COVID-19 Clinical impression, Fever, Generalized Body, Aches, Chills. Chief Complaint Patient presents with Fever, Generalized Body Aches, Chills. HPI: 52-year-old male with history of diabetes, hypertension, obesity presents the emergency department with gradual onset of moderately severe generalized nasal congestion with associated cough unproductive of sputum and fever, T-max 103.8 at home the patient states began approximately 1 week prior to arrival. The fever worsened today and he decided to be seen at that time. He states he had his first dose of Pfizer COVID-19 vaccine 3 weeks ago. Denies sick contacts, chest pain, shortness of breath, syncope, dizziness, lightheadedness, numbness, focal weakness, abdominal pain, nausea, vomiting or diarrhea, changes in bowel or bladder habits or other complaint. No other signs or symptoms and no treatment prior to arrival. ED Discharged 5/1/2021 - 5/2/2021 (5 hours). Last attending Treatment team COVID-19 +1 more. Clinical impression, Chest Discomfort, Chief complaint. ED Provider Notes. Expand AllCollapse All. HPI. Chief Complaint Patient presents with. Chest Discomfort. Patient History. 52-year-old male with history of asthma, diabetes, heart murmur, hypertension, obesity, sleep apnea and was seen in the emergency department yesterday complaining of generalized nasal congestion, fever and cough and was discharge with a diagnoses of COVID-19 4/30/2021 presents to the emergency department with complaint of chest tightness. The patient states that tonight he developed chest pain which woke him from sleep. He describes the pain as burning. He states the pain is similar to the pain he had when he had a gallbladder attack. He also states the pain is well localized and does not radiate. Initially the pain was 10/10 initially and is currently a 4/10. He took his temperature and states he had a fever of 101.6 and took 1,000 mg of tylenol just prior to arrival. His O2 saturation today has not gone under 90%. Medical History. Past Medical History: Diagnosis Date Asthma 5/29/2017, Diabetes mellitus, Heart murmur, Hypertension, Obesity, Sleep apnea, obstructive. APAP 8-20CM WME AIRVIEW. Surgical History. Past Surgical History: Procedure Laterality Date CARDIAC CATHETERIZATION 03/2004. OTHER SURGICAL HISTORY ear surgery as a baby. STRABISMUS SURGERY repair of congenital strabismus-childhood. Family History. Problem Relation Age of Onset. Hypertension Mother. Diabetes Father. Hypertension Father. Hearing loss Other. Kidney disease Other. Social History. Tobacco Use. Smoking status: Never Smoker. Smokeless tobacco: Never Used Vaping Use. Vaping Use: Never used. Substance Use Topics. Alcohol use: No. Drug use: No. Review of Systems. Constitutional: Positive for fever. Respiratory: Positive for chest tightness. Cardiovascular: Positive for chest pain. All other systems reviewed and are negative. ED to Hosp-Admission. Discharged 5/4/2021 - 5/6/2021 (2 days) Hospital. Last attending Treatment team Acute hypoxemic respiratory failure due to COVID-19. Principal problem. Presenting Problem/History of Present Illness/Reason for Admission. Acute hypoxemic respiratory failure due to COVID-19. Hospital Course. Patient is 52 yo BMI around 40, presents to the hospital with severe sepsis secondary to COVID-19 pneumonia. He was first positive on 04/30, had progressive shortness of breath with weakness and worsening cough. He presented to the hospital originally on 05/04, and desaturated to 85% on room air. He admitted to the medicine service, pulmonology was consulted. Severe sepsis (tachycardia, tachypnea, and fevers with acute hypoxemic respiratory failure) secondary to COVID-19 pneumonia. He was started on dexamethasone IV, and transition to oral dexamethasone. He will continue 7 more days at home to complete 10-day therapy. He was started on remdesivir therapy and received 3-day treatment. Pulmonary consulted, as he was a possible candidate for Actemra, however his inflammatory markers including D-dimer, ferritin, CRP improved, and his oxygen requirements also improved. On discharge, he will continue with oxygen supplementation 2 L with rest, 4 L with activity, 2 L with sleep to be infused into his CPAP therapy. Hyperlipidemia. Continue rosuvastatin 10 mg Monday, Wednesday Friday. Benign essential hypertension. Holding hydrochlorothiazide Continue lisinopril and metoprolol.

I had the shot on the 8th, The first 24 hours I was tired and had some injection site soreness. Day 2 until now I have had numbness in legs and feet. A huge lump appeared a few inches from injection site. My whole body feels swollen and tender. My eyes are swollen and my vision is blurry. It feels like someone is poking my internal organs. I am tired all the time and I have pain in back. I am scheduled for second shot in a week and now I am very afraid that the side effects will be worst after the second shot or possibly permanent.

Numbness/tingling right arm since vaccine. Sweaty palms since vaccine. Chest pain starting 18MAY, shortness of breath associated with it 20MAY, continued chest pain with relief when leaning forward- concern for pericarditis

Joint pain in hands. No history. Continually getting worse now for 6 weeks. Going to seek medical appointment. Swollen lymph nodes under arms for 6 weeks. No history.

feels like there are little tiny baby hands pinching his internal organs throughout his abdomen; Eyes swollen and his vision was diminished; Eyes swollen and his vision was diminished; On his injection arm- 2 inches away from the injection site appeared a size of a gigantic golf ball/A huge lump appeared a few inches from injection site; Numbness from his ankle to his feet and from his knees to his feet/numbness in legs and feet; feels like it's cold and tingly; feels like it's cold and tingly; ringing ears; pressure in his neck to his injection site; back pain/pain in back; vision is blurry; throat was swollen.; Toes locking up; Really dizzy and really lightheaded; Mind has been foggy; Glands were swollen; Arm soreness; Nose is bone dry; tiredness/tired; injection site pain/injection site soreness; This is a spontaneous report from a contactable consumer (patient, self-reported). A 52-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EW0173 and expiry date was not reported), via an unspecified route of administration, in Arm Left, on 08May2021 at 02:38 PM, as a single dose for COVID-19 immunization. The patient did not receive any other vaccine in four weeks. The patient's medical history included Bug bite (happened 5 days prior to 30Apr2021 and regimen of an antibiotic). He was completely done with the rotation for a least 8 days before he got the vaccine. It might have something to do with this. concomitant medication included dicloxacillin (started it on 30Apr2021 and it was for 5 days. He did not know what it did was). The patient reported that on 08May2021, day one, he experienced, tiredness and injection site pain. On day 2, until now side effects which had not gone away. It hadn't gotten worse, but it was not any better. The patient felt like congestion, but his nose was bone dry, like crusty dry. It hurts a little bit because it was so dry and he had arm soreness, nothing out of the ordinary. The arm soreness was just normal injection stuff. At first it was a little tender on the injection spot. It went away after about a day. On 10May2021, the patient felt like there were little, tiny baby hands pinching his internal organs randomly throughout his abdomen. It was not a sharp pain, more like a little squeeze all through his abdomen. It felt like his whole throat was swollen. It was not visually swollen, it more felt like a football in his neck. Stretching it was helping. His toes have been locking up like a pre-clamping. He had numbness from his ankles to his feet for 8 days, and now he has numbness from his knees to his feet. It was not completely numb, but it was not normal. The feeling of baby hands pinching his internal organs started the second day after the vaccine and has stayed consistent. The patient's eyes swollen, and his vision was diminished. Day 2 through today, it felt like his eyes were swollen, his vision was seriously diminished, he had a golf ball sized welt on his arm not at the injection site but 2 inches from it, and he was really dizzy and really lightheaded and almost fainted at the corner store. The feeling like his eyes were swollen started on day 3 after the vaccine. The crease of his eye be-low the eyebrow and on top of the socket got red and puffy and looked like sunburnt skin does. It was at the point that now it feels swollen all the time almost like he had pink eye and his vision has been diminished about 30%. He had a test done yesterday and his vision was 20/25. Some-times he could not even read a text and had to stare at his phone for 10 minutes to make out words. He did not have these issues before. The feeling of his eyes being swollen was a little better in the mornings and about 1300 it gets worse when he gets lightheaded to where was when it started. His vision became diminished about day 3 after the vaccine. It was a little better in the morning, but in the afternoon, it goes to exactly the same as when it started. He noticed the golf ball sized welt on his arm about 3 days ago. The doctor seemed to think a drop of the injection might had travelled from the injection site and his body was creating a defense to it. It was scary to take a shower and then see that. It didn't hurt. It was not painful, but it was a weird foreign entity. The cramping in his toes started probably day 3 and was consistent. The numbness started on day 2 after the vaccine, and up until 3 days ago it was just his ankles and feet. 3 days ago, it got to the point where it was from his knees to his feet. It has gotten worse since it was now travelling up his legs. On his injection arm- 2 inches away from the injection site appeared a size of a gigantic golf ball - when asked with his doctor he said that he thinks that a drop of the vaccine travelled and his body building a reaction to it and it was very abnormal. The patient also had numbness from his ankle to his feet worsened and from his knees to his feet- almost feels like it was cold and tingly. The patient also had dizziness and lightheaded about day 2 after the vaccine and it was the same. It came in waves but was consistent throughout the day. He would be fine then had a wave of dizziness. He has been laying down so much because he was so tired, ringing ears, felt like his glands were swollen, pressure in his neck to his injection site, and back pains. The patient stated that his doctor was only form urgent care. The patient Felt like whole throat was swollen, toes locking up, really lightheaded, mind has been foggy, and arm soreness. The patient had bizarre side effects from the Covid Vaccine for 11 days now. He thought it was the smart thing to report them to Pfizer. He didn't like to give personal information. He declined to give his mailing address or his email address. He hated when asked for race, but he guessed it might be important. He did not have a mailing address, phone number, or email address handy for his physician. He went to Urgent Care yesterday to have it checked and they did an EKG and said he had to be sent by ambulance to the ER. The doctor did bloodwork, and she said everything looked alright and to rest a few more days and keep hydrated. The patient underwent the lab work and procedures which included chest X-ray with unspecified result. He thinks it was on 18May2021. His mind has been foggy with all of that. It was yesterday or the day before. He could not be sure. He has been sleeping so much and was in a complete daze. The fogginess he had the whole time as his other symptoms, and it was the same. He has been eating well and hydrating and taking a multivitamin and Gatorade, all the things' people say to do. He asked if Pfizer has heard of this before. He was panicked it might be chronic, and he worries about the safety of the second shot for him. He was sure many people haven't reacted, but these are freaky side effects. He asked for advice and if Pfizer had heard of this before or if he was some weird anomaly. On his way to get the vaccine he asked 2 people at the city health line if they had taken it and they both said no. He asked 3 other patients and they said they took the Pfizer. One woman said she will take it when they make her. The guy who gave him the shot lied and said he wasn't eligible. It might have been his way of not having to discuss it. The events resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient was not diagnosed with Covid prior vaccination. The patient was tested for Covid post vaccination with Nasal Swab on 18May2021. The outcome of the events was not recovered. Device Date: 23May2021,Additional information has been requested.

Gout. Never had prior. Pain/swelling, inflammation. Steroid pack and Colchicine for treatment. Issue persists at time of this report.

about 2 weeks after the 2nd dose became lethargic, no appetite, sleepy, swelling in feet, painful to walk, hands occasionally also hurt, nausea on/off, diareaha

24 hours: Chills and mild tachycardia (HR 111) 48 hours: Continued mild tachycardia (HR 105-117), tmax 100.2,chilles, headache and bodyaches 72 hours: tmax 102.4, tachycardic (HR 141), hypotensive (low SBP 73), sepsis trigger from MEWS 7 at 0545 on 6/21, procalcitonin increased to 111.66 ng/mL right upper quadrant pain. Blood cultures drawn. 96 hours: ongoing hypotension, lactic acid increased to 4.0. Admit to hospital for pressor support. Suspected cholecystitis w/drain placement. Blood cultures drawn at 72 hours showing GNR. Eventually confirmed as Klebsiella oxytoca

My lymph nodes are swollen pretty bad; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6202) via an unspecified route of administration in the right arm on 03Mar2021 at 12:00 (at the age of 52-years-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8727) via an unspecified route of administration in right arm on 24Mar2021 (at the age of 52-years-old) as single for COVID-19 immunisation. Medical history included asthma and hernia. The patient had a history of allergy to penicillin (MANUFACTURER UNKNOWN) and ibuprofen (MANUFACTURER UNKNOWN). The concomitant medications included omeprazole (MANUFACTURER UNKNOWN) and ciprofloxacin (MANUFACTURER UNKNOWN) for an unknown indication. The patient did not receive any other vaccines within four 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 tested for COVID-19. The patient experienced swollen lymph nodes on 17Mar2021 at 13:15. Therapeutic measure was taken as a result of swollen lymph nodes and included treatment with antibiotics. The adverse events resulted in doctor or other health care professional or clinic visit. The clinical outcome of swollen lymph nodes was not resolved at the time of this report. No follow-up attempts are needed. No further information is expected.

Spoke with patient today. He received the pfizer Covid-19 vaccine from us. The first shot was given on 4/15/21 (ndc: 59267100001, lot: ew0151, exp: 07/31/21; given in left arm/im) and the second shot was on 5/6/21 (ndc: 59267100001, lot er8736, exp: 07/31/21; given in left arm/im). After the second shot, he stated he began to have adverse effects. He says it started with dizziness and feeling underbalanced. The adverse effects continued to worsen to when he would turn his head left or right, he felt like he was in a fog and had to wait for his mind to caught up. And now within the last 2 weeks, he has had swelling on each side of his neck that is worse in the evening. He has checked with his primary care doctor. Patient reports that his doctor has done bloodwork, which was normal other than his cholesterol being elevated and the doctor did a CT scan of his head that has come back normal. Patient is now following up with an ENT. Patient and I called Pfizer today to get information on whether others have reported these same effects with the duration he is experiencing these effects. The reference number given to us by Pfizer was 51k4tadq.

Extreme Arm Soreness Painful axillary lymphadenopathy on side of injection Flu like symptoms (Fever, HA, Muscle aches, malaise, chills) Abdominal cramping

Headache, NauseaVomiting, swollen and painful left axilla and left arm; chills, strange taste in mouth Narrative: 1/5 received vaccine. 1/6 woke up with left arm/axilla swollen and painful, severe headache, nausea, and chills. Also has a strange taste in his mouth. He stayed home from work. 1/7 employee reports fever overnight, chills, and lump under his left arm has enlarged. Advised to see his PCP. 1/8 left axillary lump has decreased from softball size to baseball size. It's still tender. His arm pain has improved. Headache, nausea, and chills have resolved.

swelling of the lymph nodes; fever; right arm injection site pain; aches and pains; chills; This is a spontaneous report from a Pfizer-sponsored program via a contactable consumer (patient). A 53-year-old male patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL0140), intramuscular on 04Jan2021 at 13:00 at single dose in right shoulder for covid-19 prophylaxis. There were no medical history or concomitant medications. The patient experienced fever, right arm injection site pain, aches and pains, and chills on 05Jan2021, swelling of the lymph nodes on 06Jan2021. Event details: On 05Jan2021 in the morning, he started having a fever and chills. He stated that he noticed the injection site pain on the 05Jan2021 and stated that it only hurt at time of reporting if he pushed on it. He stated it did not hurt when he moved his arm around. The patient stated that he noticed the aches and pains on the 05Jan2021 in the morning and it stuck with him throughout the day and was over by the time he went to bed on 05Jan2021. Wednesday 06Jan2021, toward the early morning around 0300 under his arm hurt and the lymph node under his arm was swollen about the size of a baseball. The patient said that his fever was currently 99.5 in Jan2021. The outcome of events fever and swelling of the lymph nodes was not resolved, outcome of right arm injection site pain, aches and pains was resolved in Jan2021, outcome of event chills was unknown.

Adverse event: 2 of 7 people received a more concentrated dose of the vaccine. One vial of two was diluted incorrectly with less Normal Saline than require. This error was not noticed until person mixing vaccine said they were out of vaccine and did not have enough to get 5 dosages of 0.3ml. Two people mixed one vial of vaccine together demonstrating to the other. It appears the person making the error did not notice they did not have 1.8ml of NS but must have had some air and did not realize it. The error was noticed when all the vaccines were given and one person had not completed pulling up the vaccine. So, 2 of 7 patients received the incorrect dose of vaccine and it could not be determined which two received the incorrect dose. Patient report; slightly sore arm, some slight body aches---resolved

-Patient had Mild rash stating to cervical area on 1-12-2021 @ aprox 11AM. AT 1600 rash was rasied & itchy & Facial swelling to Lips, eyes & tongue was noted. Provider notified 50 mg PO BenadryL given with positive effects reaction resolving by 1-13-2021 Resident has never had reactions to any vaccines recieved at any Time.

Sudden onset of dizziness, lightheaded ness, nausea, swollen glands at cervical region, fatigue, body aches; lasting 5 hours. Ongoing gland swelling with meals.

Noticed that a lymph node under his left arm was swollen; This is a spontaneous report from a contactable consumer. A 53-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283, expiration date: 30Apr2021), via an unspecified route of administration on 21Jan2021 at single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient noticed that a lymph node under his left arm was swollen on 22Jan2021. That is the same arm that he got the vaccination. Therapeutic measures included Advil. Outcome of event was not recovered.

looked like pancreatitis; developed increased LFTs; This is a spontaneous report from a contactable physician (patient). A 53-years-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, saoluion ), via an unspecified route of administration on the left arm on 07Jan2021 at 08:00 at a single dose for COVID-19 immunization. Medical history included hyperlipidemia and benign prostatic hyperplasia (BPH). The patient has no known drug allergy (NKDA) and no known food allergy (NKFA). Concomitant medications included duloxetine hydrochloride (CYMBALTA), acetylsalicylic acid (ASPIRIN 81), diphenhydramine hydrochloride (BENADRYL ALLERGY [DIPHENHYDRAMINE HYDROCHLORIDE]), multivitamins [vitamins NOS] (MULTIVITAMINS [VITAMINS NOS]). Prior to vaccination, the patient was not diagnosed with COVID-19. The patient previously received the first dose of BNT162B2 (lot number: eh9899, expiration date: unknown), at the age of 53 years old, on the left arm on 17Dec2020 for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient developed increased liver function tests (LFTs) that looked like pancreatitis on 08Jan2021 at 12:00. Treatment received for the adverse event include addition of PPI. The events resolved with sequel. Information on the lot/batch number has been requested.

This is a spontaneous report from a contactable physician. A 53-year-old male patient received his second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number pfel0410) on his left arm, intramuscular on 04Jan2021 14:30 at a single dose for covid-19 immunization. Medical history included hypertension. The patient's concomitant medications were not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 15Dec2020 (first dose). It was reported that about 1 week after 2nd dose, the patient had diffuse edema of face, hands and legs. After edema resolved, skin on fingertips peeled off; all on 11Jan2021. Labs for kidney, liver and thyroid were checked and everything normal. No treatment was received for the events. The outcome of the events was recovered with sequel.

Patient had 1st dose of pfizer and 45-60 minutes later had anaphylaxis in which an epipen was administered. Patient was taken via ambulance to The hospital

Sharp pain in groin area that would last 1-2 seconds and intermittent on frequency. It seems like it might be where a lymph node is located. Frequency has reduced since day of vaccination

Swollen/Sore lymph node in right armpit (same arm as injection was administered) occurred about 19 hours after injection and lasted until about 36 hours after injection. Physician was NOT contacted. Ibuprofen taken for pain. Condition was resolved with no medical intervention.

Swollen lymph node in arm pit 2 days after shot. 4 days after vaccine, swollen testicle and tube (Epididymis). It has now been 6 days since vaccine and still swollen testicle and tube. Armpit gland swelling has gone away.

On day one: Pain Injection site. Pain eased after 5th day. On day 6 after the vaccine, discomfort on left armpit that progressed to strong Pain on Lymph Nodes (Left armpit). Some swelling but not much. Applying cold compresses. Day 8 after the vaccine, pain continues and not lessens.

Placed follow up called on 4/5/2021 at 1:25pm: Patient reported he is still feeling warm since rcvding 2nd dose on 4/1/2021. Patient also reported on 4/4/2021 there's a sore on the outside of his mouth, and this morning 4/5/2021 the tip of his tongue is red and there is a sore inside his mouth (reporting that there's discomfort inside his mouth when he consume something hard or drink hot beverages). Patient reported on 4/1/2021 in the evening he had high fever (temp 101.9 degree) that occured through Friday morning (4/2/2021), he reported taking Tylenol one time on 4/1/2021 evening and then continued to take Tylenol 3 more times on 4/2/2021. Patient reports that his left armpit is still swollen, and has been swollen for 3 days now, there is pain if pressure is applied to the swollen area. For the swelling in the left armpit patient reported taking Aleve one time on 4/3/2021 but that did seem to help with the swelling. Recommend patient to stay hydrated, and to take Tylenol as need for any fever or pain but not to exceed a dose of 4,000mg per day. Also recommend patient to contact PCP for further evaluation of symptoms. Patient reported will try to get in to see his PCP either 4/5/21 or 4/6/21. Advised will follow up on Wed 4/7/21 after 1pm. Follow up on 4/7/21. Spoke with patient he stated he's feeling a lot better. Fever subsided same day after taking the tylenol. Patient saw PCP on Tuesday 4/6/21 and he was prescribed a steroid. He stated the mouth sores and armpit swelling are 80% better. Patient is overall doing and feeling a lot better. Advised to continue with the medication pcp prescribed and to call if he has any questions or concerns.

2 am sunday morning I woke up with pain in my left wrist and hand. A blood vessel traveling through my hand and about 3 inches up my left arm felt like a rope to the touch with some swelling between my 3rd and 4th fingers. No redness or hot to the touch. Sunday morning at 9am the blood vessel returned to normal. However Sunday night at 830 pm the swelling and pain and rope like feeling of the same vein returned and the area is the same as of now [2pm Monday the 12th of April ].

Headache, neck, shoulder and chest muscle aches started about 20 hours after the shot along with swollen lymph node in left arm pit.

DEVELOPED A RASH/HIVES/SWELLING IN AREA JUST BELOW MY ARMPIT AROUND MY RIGHT PECTORAL MUSCLE. I NOTICED IT WHEN I WOKE UP FRIDAY MORNING, 4/9/21, THE DAY AFTER MY SHOT AND IT STAYED WITH ME UNTIL SOMETIME DURING THE DAY MONDAY, 4/12/21. THE SHOT WAS GIVEN IN MY RIGHT ARM

Patient received 1st COVID vaccine on 3/17. On 3/24, he experience pleuritic chest pain and was admitted to the hospital for pericarditis confirmed by EKG. During this hospitalization, he was incidentally found to have left main stenosis 60-70% on the LHC, requiring PCI. Patient did not have an acute MI - hence Dressler Syndrome was thought to be less likely. He was discharged after a week on 3/30/21 with colchicine and other cardioprotective medications. He received his 2nd vaccine on 4/7/21. On 4/14/21, patient was readmitted for pleuritic chest pain attributed to recurrent pericarditis.

Extreme fatigue; achy muscles; chills; 102 degree fever; inflammation under left arm pit; sore joints; headache; injection site pain; general sick feeling.

6 days after 2nd vaccine: 1. Tinnitus - left ear. No treatment. Disappeared after 12 hours. 2. Sore tongue, lymph nodes, throat. Gradually subsided after 4 days.