Pfizer

Onset of swelling in neck. Reported via phone that he has 2 lumps that began yesterday. He also said he started experiencing an allergic rash on his back. Advised to seek medical care.

Approximately 2 hours post vaccination a heat flash came over my body, co-workers setting around me asked if I was ok as my face was red, cleared about 1 minute later. About 15 minutes later a 2nd heat flash came over my body and cleared about 1 minute later. About 15 minutes later the 3rd heat flash came across my body and cleared about 1 minute later. Approximately 30 minutes later my head was in a fog, I could not focus, thoughts left my mind. When returning to my office my manager asked if I was ok and said my eyes were glossed over and my face was red. All this cleared around 2:30 pm.

Approximately 2 hours after receiving the vaccine I felt a heat flash, people setting in the area asked if I was OK as my face was red. It cleared in approximately a minute. The 2nd heat flash came on about 5 to 10 minutes later and cleared about a minute later. The 3rd heat flash came on about another 5 to 10 minutes, again clearing at about 1 minute. Next I felt like my head was in a fog, found it very hard to focus, and was forgetting what I was doing. I walked over to the office, my supervisor asked if I was ok as she said it looked like my eyes were glazed over, my head was still in a fog. This cleared by 2:30 p.m.

Fever 103+ the night of. Deep fatigue and low grade fever the following day. Large area of pain and inflammation near injection site. About 7 inches by 3 inches. Fever resolved by the evening of the day following administration, fatigue was mostly resolved also. Inflammation and pain at site lasted about 5 to 6 days.

per patient report: broke out with generalized rash with itching 4 hours following initial vaccine, took diphenhydramine and issue was resolved, rash lasted x3 days

1/19 2300- INJECTION SITE DISCOMFORT 1/20 0100- FEELING OF FEVER, BODY ACHES, SORE THROAT 0830- NAUSEA, FATIGUE 1050- TEMP 100.4. TOOK TYLENOL 1000MG @ 0100 AND @1030

Pain in Deltoid Muscle at injection site got progressively worse after injection. Used Tylenol an hour later with minimal affect. Applied Aspercream to site 14 hours later with minimal affect. Never had that kind of Soreness in my arm after a vaccine that continued into the next day.

Elevated blood sugar, unable to get it under control. Right side of skull and face extremely painful, including tongue lips, teeth eye, skin. Some soreness continued after 2 days.

Pt received the 2nd dose of the COVID vaccine on Sunday 1/17/21 and developed a sore arm, but otherwise had no symptoms. By Tuesday 1/19/21, he was having shooting pains through his shoulder and down to his elbow. By late Wednesday, he had started to develop hives on his palm, between his fingers, and up to the elbow. Pt states he has a history of a pinched nerve in his neck and elbow, but this pain is nothing like his usual pain. On 1/22, pt presented to the ED for left uper arm pain and rash. He denied new detergents, foods, clothes, wooded area exposure. Denied decreased ROM in shoulder, but ROM makes his shoulder sore. BP 161/82, otherwise vitals normal. Rash did not apear infectious. No evidence for DVT. Pt received ketorolac 30 mg IM x 1 in ED and was prescribed hydrocodone-APAP 5-325 mg tabs PO Q6h PRN #8. Pt was instructed to follow up with PCP in 1-2 days. By 1/25/21, pt reports the hives have become dark purple, like bruises. He states he has trouble making a fist and is not using his left arm at all - when this writer spoke to him, he said it was "gimpy." Pt stated during the phone call that he was about to call his PCP for a follow up appointment.

Received vaccine at 10:44am. My arm was a little sore almost immediately. Approximately 12:30-1:00pm, I started getting a bit nauseated, pit in my stomach . Lasted until went to bed around 9:00pm. In morning felt fine except my arm felt much more sore at the shot point for about 2-3 hours after I woke up. 10:00am everything is normal.

0900 - Pfizer Shot 1000- noticed eyes looked puffy 1100- rash started on left arm below bicep in the elbow area 1115- rash now showing on right arm in the same area Around 1230 - 1300 seen by EMT - at that time I was given a shot of Epinephrine and IV of Benadryl transported by ambulance to ED to be evaluated for allergic reaction. was released from the ED around 1545 no other treatment needed

Abdominal rash with hives, right arm rash with hives, eye itching, nasal itching, throat swelling sensation

Patient experienced a hive/rash like reaction all over the body around 4 days after the vaccine that progressively worsened. Patient went to to see a doctor on 2/17 and the doctor prescribed hydroxyzine and a cream to help with the hives, which helped lessen the symptoms but was unable to rule out that the reaction was caused by the vaccine. The doctor recommended that the patient still receives the 2nd dose of the vaccine.

After he exercises ever since he received the vaccine, he has been getting exercise induced urticaria that lasts for 1-2 hours and is moderately pruritic. He said he feels as red as a lobster for an hour or two before it goes away.

-Sore muscle around injection site lasting for about 24hours -approximately 24 hours after injection I had muscle, joint and skin aching all over my body that lasted about 7 hours

Swelling in both lower legs and severe rash and itching. Lasted for 2 days. Still experiencing some form of it on day 3. But swelling has subsided and rash is healing.'

Loss of taste; right kidney pain severe; injection site pain; This is a spontaneous report from a contactable consumer (patient). This 60-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; dose 1) via an unspecified route of administration on 25Jan2021 at 10:00 (at the age of 60-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included chronic back pain, scoliosis, kidney stones, 3 double hernias, venous deficiency, fibromyalgia, 2 torn ligaments right foot, diabetes, and diabetic neuropathy. The patient did not receive any other vaccines within four weeks prior to the vaccine. The patient did not have COVID-19 prior to vaccination. The patient received unspecified concomitant medications. The patient previously took morphine from an unknown date for an unspecified indication and experienced allergy. On 25Jan2021 at 10:15 the patient experienced loss of taste, right kidney pain severe, and injection site pain. The patient was not treated for the events. The outcome of the events was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.

Soreness at Injection site Lasted one day. Soreness in both shoulders and both upper legs near groin area till 2:00am heart palpitations started one hour after injections and lasted for 2 1/2 hours.

Mild symtoms. About 25 minutes after receiving injection felt slight inflammation on both cheeks near the nose, also notice splotchiness on cheeks. In addition felt slight itch on inside of both elbows which presented a couple hive-like bumps not previously there. These symptoms continued for about 15 minutes and then began disappearing by the time I reached home. After 45 minutes all adverse reactions were no longer present. No adverse reactions occurred following this except for a sore left arm at injection site. Arm soreness was abating by 9pm on same date and pretty much gone by next morning. No additional medication was taken for for any of the reactions. A cool compress was used on the left arm.

Patient was monitored for 30 minutes after first dose of Pfizer vaccine as he reported rash after taking PO Sulfa medication. Per pt he has had no reaction to flu vaccines in the past. Patient left clinic at 0932 but later returned at 0940 c/o feeling loopy. BP at 0940 180/97 HR 63, Radial Pulse 60, Oxygen saturation 100% RA. BP at 0945 172/96 HR 60 left arm. BP at 0958 left arm 167/82 HR 57. Patient monitored by NP and was advised to follow up with his primary care doctor. Pt reports he had derma filers a few weeks ago. Patient c/o feeling redness and numbing in his cheek bones and feeling loopy. Per pt denied history of hypertension only had 2 cups of coffee this morning. Patient?s husband will pick up patient and take him to Hospital as he was advised to do by his primary care doctor who he spoke with while in clinic. Temperature 97.5 F on forehead. Pt declined feeling any itching. Patient was picked up by husband and he will drive patient to Hospital. BP at 1043 184/94 HR 64 Apical Oxygen saturation 97% RA. Patient denied any itching, stated swelling in cheeks and tingling has improved. NP walked patient out of clinic.

The described waking up around 9pm after going to be early the day after he received the vaccine. He said that his hands burned and itched. He took Benadryl and the symptoms eased after about an hour. He reports he had a similar experience after being exposed to rubella many years ago. At that time the symptoms spread to his whole body.

12-14 HOURS AFTER RECEIVING THE VACCINE PATIENT REPORTS HE DEVELOPED HEADACHE, MUSCLE ACHES, CHILLS, SWEATS, LOSS OF APPETITE. HE ALSO NOTED A RASH ON HIS NECK, FIRST ON THE NECK AND NOW HAS SPREAD TO THE ENTIRE BODY. PATIENT ALSO REPORTS SHORTNESS OF BREATH WHEN LAYING FLAT ON HIS BACK THAT STARTED AT THE SAME TIME.

3-4 days after 2nd dose, large areas of bruising on arms (bilat), torso (all areas) and one on left thigh. Increase of pedal edema from Trace/1+ to 2-3+. Unexplained breaking of all finger nails. No pain or itching (pruritus) associated with bruises. No new meds (Rx or OTC) started during the week prior to first injection to this day. No real symptoms to treat so nothing done. Areas of bruising hace increased but are now starting to fade. No specific treatments done as there was nothing to be done other than to consult my PCP.

Hives/rash on back, stomach, legs and arms. Dr. prescribed Triamcinolone 0.1% cream and an epi pen in case for the second shot

Patient stopped in a few days after vaccine given, injection site had 3 reddish dots near injection site (dots appears horizontally to each other). Also some other subdermal redness in area

Pt complained of lightheadedness , itching which worsened and he became flushed. Progressed to generalized pruritis and redness. BP 117/74, HR70 )2 95% Epi 0.3 IM and Paramedics notified, transported to hosptial

FIRST: An ache at the injection site progressing to a throbbing aching. The peak-pain lasted 18 hours. Icing the area did nothing to reduce the throbbing. SECOND: Progressive Myasthenia Gravis weakening began about 20 hours after the injection. It was escalating toward being a full-blown crisis. I have an emergency stash of Prednisone, and I alerted my Neurologist that I began taking it. Prednisone effect saved me from a full-blown bulbar deficit, which would have required hospitalization. For MG, I've long only needed to take CellCept to be symptom-free. The Pfizer shot IS to blame for the MG exacerbation

Sore arm at injection site that became more sore as time went on. Resolved to little pain inn less than 24 hours.

Upper left side chest discomfort. Pain persisted moderately for 3-4 days, and slowly began fading. By 10 days the pain had almost completely ended. About 19 days after shot I had an unusual bruise appear on my right foot, which was not due to any impact, and has just a little pain

Systemic: Fainting / Unresponsive-Mild, Additional Details: Small laceration on right ear from falling into shelving area. Cleaned and applied pressure by who was first on scene.

The following day after the second shot, I had a fever for 24 hours, lost my sense of taste, injection site pain, weakness/fatigue, chills, swollen lymph nodes/sore throat. 96 hours later (as of this writing) still have diminished sense of taste, swollen lymph nodes/sore throat, quick fatigue.

4 days post vaccination began having "chest or heart pain", later started with painful rash. Diagnosed by provider with shingles on 03/22/2021

1) Cup right ear with hand; Arc described from thumb to little finger, 1/2 -1" depth. Needle sharp jabbing pain, lasts for an instance, yet whole arc "lights up"/pain felt throughout arc. Jabbing every 10-15 secs. Started ~08:00pm 03/03/21 (day after vaccine administered), and continued through the night, till mid-next day 04th. 2) Headache 3/02/21 6pm for the week ( through to 3/9/21) 3) right arm, site vaccine administered, bruised to the touch.

Patient had itchy and red rash on hands Friday evening (03/19/2021). The rash proceeded to get very bad according to the patient on Saturday (03/20/2021). The patient took Benadryl on Saturday, Sunday, and Monday which made the rash better.

Five Day extremely itchy and red eczema-style rash on outside of elbows, almost entirely gone at three weeks.

Rash on front torso, both arms, both legs, groin . Rash on legs severe to point of weeping and cellulitis

numbing of right hand side of face/mouth and right arm. symptoms subsided after about 10-15 minutes but continued to present every few days. I advised when i presented for my 2nd shot and they told me they had other reports of that and that is was fine/safe for me to take the 2nd shot, but to wait in a holding area for 30 minutes after the shot.

Patient developed a rash on the right side of abdomen 3 days after 1st vaccination. Rash has persisted for and not resolved.

Itching and hives on inner arm - same arm as vaccination, but not at vaccination site. No other known exposures to substances that could have caused this reaction. No prior hive reactions. Taking OTC loratadine to allieviate symptoms.

Severe hives outbreak all over the body 4 days after second dose of Pfizer vaccine. Hives started in groin and armpit then expanded to forearms, knees, neck, eyes, hips, back, tailbone area, head, and was severe in the hands and wrists. Also -- The evening and through the night after the second dose (given at 8:35 AM) side effects included headache, chills, fever, muscle aches.

Site: Pain at Injection Site-Medium, Systemic: daughter described it as \"ants crawling under skin\"-Severe

Site: Pain at Injection Site-Mild, Error: Wrong Dose of Vaccine - Too Low, Additional Details: NO aderverse event, only syringe malfunction. vaccine leaked out of Vanish syringe when administered. we re-administered an additional 0.2ml of pfizer covid vaccine. patient reported he has had covid before.

Initially headache, and sore arm at injection site. Only sore on contact and not too bad. Fatigue and loss of muscle strength (I am a hard core cyclist), not detectable during normal activities. A week later it persists. On the fourth evening, I could not stay asleep. As soon as I would drop off I would dream. It would be a violent encounter. I would physically strike out and I would wake up.

Arm pain at injection site started 24hours later lasted 72 hours, Drowsiness started with in hours of injection lasted 48 hours,Sweating,Vomiting ,Dizziness,chills and Rapid heart beat started 48 hours later,sweating and vomiting lasted and hour.Rapid heart beat lasted about 15 min. Took anti nausea medicine for the vomiting and Tylenol & Motrin for arm pain.

Day 1-Chills/Shaking, Body Aches, Dizziness, Itchy Throat, wheezing breathing, difficult walking, extreme fatigue, Abdominal cramping. Day 2-Injection site pain, Nausea, fatigue.Day 3-Nausea,fatigue.Day4-Extreme lower and mid back pain, indigestion, gas, bloating, constipation.Day5-Fatigue lower back pain.Day6-Fatigue,lower back pain.Day7-Fatigue,lower back pain.Day8-Fatigue, Rash appears on torso and back, red bumps and itchy, Fever onset.Day9 Fatigue, Fever, rash itchy red bumps.Day10-Joint pain onset, Knees swollen large, reduced range of motion, hamstrings cramped up. Feet swollen and tingling. Rash over entire torso.Day11-rash abated, knees and legs swollen with limited range.Day12-Cramps hamstrings and knees swollen. Day13-Knees and leg cramps, fatigueDay14-Knees and legs cramped, fatigue.Day15-nausea,fatigue, hives on side and feet.Day16 Migraine onset, severe nausea, high fever, no sleep.Day17- extreme migraine, fatigue, nausea, hives.Day18-migraine,nausea,hivesDay19-Nausea,hives,fatigueDay20patchy hives, fatigue. Fatigue through to April 1, Skipped second dose.

Headache, muscle aches, chills, high fever, rash,, swollen joints, fatigue, minor chest congestion lasting 9 days. Administered Tylenol, Ibuprofen, Mucous DM. Tested negative for Covid 19 on rapid and lab test.

Site: Swelling at Injection Site-Mild, Additional Details: The Pfizer vaccination was reconstituted according to the CDC guidelines and using aseptic technique. After the pfizer vaccine was administered into the left arm deltoid muscle, the surrounding tissue immediately began to swell and form a raised and hardened lump about one inch in diameter. The lump was about 3 degrees warmer than the surrounding tissue. The patient was instructed wait in the observation area for 30 minutes, and inform his physician.

Fatigue, Sore Throat, Chills, Headache, Some Nausea, Soreness at the Injection Site, Fast Palpitations

On March 30th, the first skin rash / bump appeared on my right wrist and was very itchy. It expanded to an area about 1 inch x 2 inches and a week later continues to be itchy. Zyrtec helps reduce the itching (I only take 1/8 of a pill because a whole pill is too strong for me) On April 4, three additional spots about 1/2 inch in diameter appeared on and around my right nipple. Later that day, three other spots about 1/2 inch in diameter appeared on my LEFT shoulder. I got the short in my right arm. The chest and shoulder spots are only slightly itchy. I took pictures - hopefully later in this interview, I will be able to upload them.

4/3/2021, Initial Stinging pain at time of injection 4/3/2021 - 4/5/2021, Pain on the left arm (injection site) extending into my shoulder and down to my wrist. 4/5//2021 - Current, Pain Reduced, but will be setting up an provider appointment. 4/3/2021 - 4/5/2021, Nauseas 4/3/2021 - 4/5/2021, Severe Headache, used Tylenol medication to reduce the pain. 4/5//2021 - Current, Light headache, Using Tylenol for relief

After warm shower & application of about 1 gram, 1% diclofenac gel, noticed mottled/blotchy patch under area of application on lower back. Skin remains mottled in excess of 12 hrs (photos avail).

Itchy, patchy rash developed over the course of first week after injection. Concentrated on upper shoulders, front and back. Some smaller patches on mid to lower back. Rash was active still at the time of second injection (4/2/21, same location, Lot EN6208). As of today, rash still itchy and irritating, but not increasing in intensity. Scratching produces tearing of loose skin and bleeding.

Pain at injection site. Progress to under the arm. Also lymph nodes under arm are noticeable to the touch and water build up on the right under arm chest wall. Some coldness in hand and occasional tingling. Shoulder area feels heavy.

Swelling on the face ( eyes and mouth) the next morning after getting the injection as well as rash all over the body to combat the reaction the patient took 2 benadryls.

I ran a low grade fever (100.1) for approximately one week. I had body aches (separate from the sore injection site for a single day starting 3/20/2021) and some headaches, but no life-threatening issues, nor enough reason to seek professional medical treatment. After the contiguous week was over, I had similar off and on symptoms for the following week, but these symptoms lessened with time.

Pain and itching around lymph nodes under armpits, breast area middle of chest, top of shoulder, upper back; Pain and itching around lymph nodes under armpits, breast area middle of chest, top of shoulder, upper back; Pain and itching around lymph nodes under armpits, breast area middle of chest, top of shoulder, upper back; Pain and itching around lymph nodes under armpits, breast area middle of chest, top of shoulder, upper back; Pain and itching around lymph nodes under armpits, breast area middle of chest, top of shoulder, upper back; Small bumps directly around lymph nodes with intense itching which feels like it's on the inside sometimes; This is a spontaneous report from a contactable consumer. A 60-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EP6955), via an unspecified route of administration, administered in left arm on 18Mar2021 12:00 as single dose for COVID-19 immunization. Medical history included SAPHO syndrome, vasculitis, gout, arthritis, carpal tunnel syndrome, hot peppers and garlic sensitivity, and seasonal rhinitis allergy, all from an unknown date. The patient has no COVID prior vaccination. The patient was not tested for COVID post vaccination. Concomitant medications included ibuprofen; pregabalin (LYRICA); methotrexate; omeprazole; and paracetamol (TYLENOL), all taken for an unspecified indication. The patient previously took Biaxin and Bactrim and experienced allergies. On 20Mar2021, 04:00, the patient experienced pain and itching around lymph nodes under armpits, breast area middle of chest, top of shoulder, and upper back. Onset was intense aching pain two days post injection. Small bumps directly around lymph nodes with intense itching which felt like it's on the inside sometimes was reported. It was a Monday night of 22Apr2021 at 9:55 PM and symptoms were static, not worsening not improving. No treatment was received for the events. The outcome of the events was not recovered.

on the crook of left arm, on the elbow part of the arm part, within 30 minutes, it turned a deep purple-red color and developed a bubble on the top. there was no pain associated with it. it is 4 days later and still visable

Burning upon injection. Numbness at injection site and entire left arm. 100.6 fever. Switch between chills and feverish and sweating. Intense pain under left breast radiating tru to left shoulder blade. 22 hours after injection, vomiting began and lasted the next 14 hours. Appetite is gone. 4th day post shot and all I've consumed is a banana and a yougurt. I has Covid 09/20 and the injection reaction was worse than Covid.

Significant rash over entire body, (torso, arms, legs, back). I am debating whether to go to emergency clinic or see my doctor. Other initial site effects (fever, chills, etc) have dissipated as of this morning.

Severe rash developed on right side of patient: back side of leg, buttocks, inner thigh and groin area. Minor rash on top of right foot. The rashes are red and include blistering. At first, the rashes included itching sensation but at this point the itching is being replaced with sensitivity and pain. Patient had a virtual visit with GP who concluded this was an adverse reaction to the COVID vaccine and prescribed a series of steroids which the patient will begin taking after 2 weeks from the COVID vaccination.

All hair fell out ... body and head since first vaccine . Coincidence?? Not sure , seeing doctors currently .

Blood clot in left leg; first noticed on March 17; swelling and pain bad by March 19, called advice nurse who told me it sounded like a blood clot and told me to go to emergency room.

several red/purple flat spots on the right foot, roughly round shape, 1-1.5 cm in size. Itching sensation.

Arm soreness at injection site and tiredness starting about 12 hours after injection. Arm soreness is a little better today (day after injection), but still feeling quite tired.

injection site pain; extreme tiredness; headache; chills; sweating; feeling unwell; dizziness; This is a spontaneous report from a contactable consumer. A 60-year-old male consumer (Patient himself) reported that he received BNT162B2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection) via unspecified route of administration in arm left on 28MAR2021 11:00 AM (at 60-years-old) as a single dose of administration. Patient medical history included high blood pressure, prostate cancer. No record of allergies to medications, food, or other products. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and patient received within 2 weeks of vaccination. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, has the patient has not been tested for COVID-19. On29Mar2021 3:00, patient experienced injection site pain, extreme tiredness, headache, chills alternating with profuse sweating, feeling unwell, dizziness. No therapeutic measures were taken for the event caused. Outcome of the events was not recovered. No follow-up attempts are possible, information about lot/batch number cannot be obtained.

developed itchy red rash around elbows with swelling and the spreading to for arms, legs at this time, applied hydrocortisone cream 1% several imes a day, rrecieved 8 mg shot of predisone shot on 4-19-2021

Joint pain, muscle aches, flatulence, hands (only) faded or appeared light brown, head ache (nail hammered into the skull pain), back pain, check tightness, and upset stomach.

Face and arms visibly flushed. HX hypertension. No difficulty breathing or tightness in throat. Vital Signs: BP 150/80 HR 72 O2Sat 97% Skin Signs: Warm and dry, Other - Very red and flushed warm to touch Circulation: Cap refill <2sec Respiratory: Breath sound clear bilaterally No increased res. effort Initial treatment: Continue observation. Patient observed to be flushed prior to vaccination. HX of rosacea. Patient states HX of sun exposure prior to clinic. 11:13 AM Vital Signs: BP 138/74 HR 76 Resp. 16-18 O2Sat 95% Possible irregular HR noted while getting BP Skin Signs: Other - Flushed A/Ox4 Circulation: Cap refill >2sec Respiratory: Breath sound clear bilaterally Follow up Treatment: Observation. No increased res. effort. Neg S/S anaphylaxis. 11:19 AM Vital Signs: BP 122/80 HR 78 Resp 14-16 O2Sat: 95% Skin Signs: Warm and dry, Other - Flushed A/Ox4 Circulation: Cap refill <2sec Respiratory: Breath sound clear bilaterally Notes: Vitals at 11:32 AM BP 130/72 HR 81 O2Sat 94% Lung sounds clear bilaterally Resp 16 Patient states no dyspnea upon sitting. Cap refill <1sec No nausea Patient instructed to update son. Released home by self.

I developed a mild case of shingles 2 weeks after my first Pfizer shot (3/30/21). Yesterday I read a news report about research in Israel identifying shingles as a possible side effect to the first Pfizer shot. I also heard several TV news reports about shingles appearing as a side effect to the first Pfizer shot. A link to the news report I found is enclosed.

Rash around injection site. Hard warm lump where needle was inserted and vaccine injected. Approx 1 in by 4 in. Shoulder is sore and feels hot. Painful to touch.

Patient reported the start of a itching hive-like rash on Tuesday night after receiving his Covid vaccine on 4/17/2021. He reports the rash continued to get worse, which prompted him to be seen by me in urgent care on 4/22/2021. He received his first dose of the Pfizer vaccine on 4/17/2021. No obvious anaphylaxis. He had a uticarial rash on bilateral arms and knees. He was tachycardic. He refused ED visit, so I treated with 50 mg of prednisone for 5 days, oral Benadryl 50 mg every 6 hours, Pepcid 10 mg over-the-counter. He reported he would refuse to fill out an adverse event via Vsafe app, which prompted me to file this report.

On the morning after the 2nd injection, about 09:00, I started experiencing flu-like symptoms: muscle aches, then I was feverish and sweated heavily, then I felt lethargic and craved sleep. I slept heavily. I experienced these symptoms for three days, from 4/20/2021 until 4/22/2021. Today is 4/23/2021 -I have muscular soreness in left arm / injection site. I also ache and have a low- grade head-ache.

Had 2nd covid vaccine shot April 8th at 1:15PM. Friday evening started feeing tingling in left arm and skin on stomach. Saturday noticed rash on stomach. Sunday rash had grown. Wend Sunday April 11th to urgent care and was diagnosed with shingles. Was given a 7 day prescription for Valtrex. Two weeks later finally beginning to to see a reduction in the rash and pain.

Shingles outbreak on right upper; This is a spontaneous report from a contactable consumer (patient). A 60-year-old male patient received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number ER 8733) at single dose on 28Mar2021 01:00 PM via an unknown route in left arm for Covid-19 immunization. Medical history included HIV. Patient had no allergies to medications, food, or other products. Concomitant drugs included emtricitabine, tenofovir disoproxil fumarate (TRUVADA) and raltegravir potassium (ISENTRESS). Historical vaccine included 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number ER 6205) on 07Mar2021 01:00 PM in left arm for Covid-19 immunization. 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. Shingles outbreak on right upper in back 2 days (as of 06Apr2021) after 2nd dose (onset date 30Mar2021 04:00 PM). The report was not serious. The adverse event result in Emergency room/department or urgent care. Treatment included valacyclovir 1,000 mg and Acyclovir 800 mg. Outcome of the event was not resolved. Since the vaccination, the patient had not been tested for COVID-19. No follow-up attempts are needed. No further information is expected.

Rash to left side x1.5 weeks- spreading to right side on legs from knee up. COVID shot 4/10 2nd-Pfizer. Rash is red, blotchy, raised, itchy, hot, irritating.

I took the covid 19 vaccine on the 04/05/2021. The following days I started to feel tired and sleepy. Some Rushes started to appear on my buttock and went down to my right leg and also under my foot, making me really difficult to walk. I have been diagnosed with Herpes Zoster (Shingles). I was prescribe with Acyclovir 800MG per 10 days! My covid 19 second dose is due on April 28. I got advised not to take second dose of the vaccine before I get better from the Herpes Zoster.

Injection site soreness, tiredness on 4/27/21. At 2 a.m. on 4/28/21 woke up with chills, sweats, fever of 102, headache, muscle pain, joint pain, nausea, feeling unwell, dizziness, weakness, injection site soreness, somewhat fast heartbeat, shortness of breath. If he talked then short of breath and would cough. About 8 a.m took 1 Tylenol. About 9:30 a.m. had major stomach cramps, barely walk but made to bathroom to throw up. Used cold wash cloth for his fever then after he threw up he ate one piece of toast, took his medications and 1 Tylenol (since he threw up the first one). Heart rate better and breathing better. Went back to bed to go to sleep about 10:30 a.m.

pt says his arm was sore the day after taking the vaccine but now the soreness has spread from the top of his left shoulder down to his fingers. He says it hurts from the skin to the bone. He cannot lay down, he has to sleep sitting upright. he said the pain is constant but is not as bad when he sits up and when he lays down the pain is so bad he has to get back up. He is taking aspirin for his pain.

Immune Thrombocytopenia Purpura; blood blisters in mouth; petechia; platelets were zero; This is a spontaneous report from a contactable consumer. A 60-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) dose 2 via an unspecified route of administration on 19Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE (at the age of 60 years old) for covid-19 immunisation. Medical history included Multiple myeloma status post (s/p) CAR T therapy (Apr2020), on Pomalyst starting from Apr2020 to an unknown date. Concomitant medications included pomalidomide (POMALYST) taken for an unspecified indication from Jan2021 to an unspecified stop date; acyclovir [aciclovir] (ACYCLOVIR [ACICLOVIR]) taken for an unspecified indication, start and stop date were not reported. On 20Mar2021, the patient experienced immune thrombocytopenia purpura, blood blisters in mouth, petechia. In Mar2021, the patient experienced platelets were zero. Clinical course was as follows Immune Thrombocytopenia Purpura- About 24 hours after receiving the 2nd dose of the vaccine, started noticing blood blisters in mouth and petechia in 20Mar2021. Patient went to doctor on 22Mar2021 after 19Mar2021 vaccine and platelets were zero in Mar2021 and prednisone was started. Platelets were still 0 on 24Mar2021, and then was admitted to the hospital and was given steroids, IVIG, and Nplate. Now improvement. Of note, platelets were checked on 18Mar2021 and were 26, and then received 1 bag of platelets and they were not rechecked after. The patient underwent lab tests and procedures which included platelet: zero in Mar2021, platelet: 26 on 18Mar2021, platelet: were still 0 on 24Mar2021, Covid test: negative on unknown. Therapeutic measures were taken as a result of immune thrombocytopenia purpura, blood blisters in mouth, petechia, platelets were zero. Outcome of the events was recovered. Information about Batch/Lot number has been requested.

After first and second night had 101 F fever. Rash started on back as mild faliculitis, now has spread to cover a large portion of his back and to his legs and arms. The rash appeared the 3rd day after the vaccine. Rash is very itchy and burns/stings. PCP gave prednisone - may have helped a little but has now quit responding. Will begin tapering.

4-5 days after first dose of Pfizer COVID19 vaccine developed circular erythematous rash over trunk and arms. Still persistent now 8-10 days later. Mild itching. No fever, chills, sweats, shortness of breath, wheezing.

Muscle pain and rash at injection site, both lasting for 3-4 days. Body and joint aches lasting 1 1/2 days. Feeling of being too warm, tiredness and chills lasting 1 1/2 days. Did not seek treatment since I knew these were normal reactions that would subside. Most of the side effects only lasted a day and a half except for the arm soreness and rash at the injection site which lasted 3-4 days.

rash; "scaly" on his abdomen & legs; it could be shingles; This is a spontaneous report from a contactable consumer (reported for himself). A 60-years-old male patient received second dose of bnt162b2 (BNT162B2, solution for injection, Lot number: not reported) via an unknown route of administration on 11Mar2021 as SINGLE DOSE for covid-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (BNT162B2, solution for injection, Lot number: not reported) via an unknown route of administration on 18Feb2021 as SINGLE DOSE for covid-19 immunization On an unknown date, the patient experienced rash, scaly on his abdomen and legs and it could be shingles. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

flu-like symptoms; Headache; fever / low grade fever after second dose; felt bad all over; face was red; This is a spontaneous report from a contactable consumer. A 60-years-old male consumer (patient) reported for himself that he received second dose of second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EW6170) via an unspecified route of administration in right arm on 19Apr2021 at 13:00 at single dose for COVID-19 immunization. The patient had Covid before Christmas. he was active and gets around. He had friends who had Covid (2020) and he had a bad run with it. The patient's concomitant medications were reported as no. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: ER8730) via an unspecified route of administration in right arm on 29Mar2021 at 09:30 COVID-19 immunization and felt bad. The patient took second dose of Pfizer covid vaccine yesterday i.e. on 19Apr2021 at 13:00. He felt bad after the first. He felt great yesterday until he started feeling bad in the evening. He went to work today, he was feeling better, but now he was experiencing a low grade fever. Caller was asking if he was a slight risk to his coworkers or if he is a potential carrier of the COVID19 virus. He knows there was no live virus in the vaccine. He was just looking for clarification. He felt like he had the flu, felt like crap. He felt bad all over. Last night his wife told him his face was red. He had an infrared thermometer at his desk, he thinks his temperature is 99.5 to 100 tops. He did not take his temperature last night but thinks the fever started last night. He started feeling flu-like at 10:30 today. He was going home after he gets off the phone. Clarified his temperature was 98.8 degrees, but he felt hotter than it reads. His face was 101.8 degrees on his cheek and 100.4 or 101.2 degrees when checking on another area. He took 3 Excedrin this morning for a headache. The outcome of events was unknown. No follow-up attempts are possible; No further information expected.

chest pressure; shingles/rash; itch and rash and tenderness on his rib cage; itch and rash and tenderness on his rib cage; chest pain; This is a spontaneous report from a contactable consumer. This consumer (patient's wife) reported for a 60-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 intramuscular, administered in Arm Left on 10Apr2021 11:00 (Batch/Lot number was not reported) as single dose for covid-19 immunization. Medical history included ongoing Cholesterol. Concomitant medication included ongoing atorvastatin taken for blood cholesterol. Patient investigation assessment was No. The patient developed a rash from 16Apr2021. They figured out in the hospital that it was probably shingles. It had developed even more. They want to give him Valacyclovir. He came down with an itch and rash and tenderness on his rib cage from 16Apr2021. He slept on his chest and had pressure on his chest from 18Apr2021 to 19Apr2021. He went to the hospital to rule out a heart attack. The patients father passed away a long time ago of the heart attack and thought it was that as well. He went to the emergency room and was brought in the hospital under observation status. He was diagnosed with shingles at the hospital from 19Apr2021. They were on the right side. The itching, tenderness and pain got worse on Sunday with chest pain from Apr2021. Patient has not received Valacyclovir yet. The hospital was waiting to give it until after caller speaks with Pfizer. The patient was currently waiting to get the antiviral medication for shingles. The outcome of the event chest pressure was recovered on 19Apr2021, of shingles/rash was not recovered, of other event was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Red marks and severe itching mostly on the palms of my hands. Fades at times. Wakes me up in the middle of night and Im scratching

Looks like shingles, body rash especially forearms and upper thighs. Began about 2-3weeks after 2nd shot and began to spread gradually. Treatment has been applying ointment.

Developed shingles rash on the left arm. Treated with ValACYclovir for 7 days. Total 21 tablets, 1 gm each. Resolved in 3 days after finishing the medicine.

Systemic: Allergic: Rash Generalized-Medium, Additional Details: Patient reported generalized rash during appointment for the 2nd dose. Rash appeared 1 week after the 1st dose. Patient did not seek medical care

Fever running around 102 it spikes to 104.5; Nausea; Bodyache; Vomiting; soreness in my arm where shot was given; rapid heartbeat; Lethargic; This is a spontaneous report received from a contactable consumer (reporting himself). A 60-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: ER8735), via intramuscular in left arm (left upper arm) on 22Apr2021 at 23:30 as a single dose for COVID-19 immunization. Previously, the patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: ER8733), via an unspecified route of administration on 01Apr2021 as a single dose for COVID-19 immunization. The patient's medical history included high blood pressure. The patient's concomitant medication included diltiazem hydrochloride tablet; once a day by mouth for High Blood Pressure, Irbesartan/ Hydrochlorot tablet; 300-12.5 mg; frequency as once in a day and route of administration as orally, daily for High Blood Pressure. Patient stated, I trying to report, I have severe reaction to the Pfizer 2nd Covid shot. On 22Apr2021, the patient experienced fever, running around 102 it spikes to 104.5, nausea, bodyache, vomiting, soreness in my arm where shot was given, rapid heartbeat and lethargic. The patient received Advil 200 mg, took two pills for total 400mg as treatment medication for events. Patient confirmed about taking the shot from the nurse. The outcome was not recovered. No follow-up attempts are needed. No further information was expected.

Within 30-min: Muscle pain across shoulder and arms. Joint pain: shoulders, elbows, fingers, knees, and toes. Mild swelling and redness in hands. Next day; mild swelling of face.

Per Client, received second COVID 19 on 4/22/2021, in the left arm. Client C/O that in 2-3 days started having joint and muscle pain throughout body. On the sixth day, joint and muscle pain worsen, and now for eight days pain is still present. Per Client, by the seventh day, started taking Ibuprofen, now having itchiness throughout body, and very fatigue. Client has not followed up with PCP, but has an appointment already scheduled in two weeks to see PCP. PHN suggested that Client try following up with PCP sooner than two weeks, to go into Urgent care, ER, and with medical emergency to call 911 if needed. Client verbalized understanding information provided.

He has been experiencing pain; Sensitivity on the right side of his gums; This is a spontaneous report from a contactable consumer. A 60-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number: Unknown. Expiration date: Unknown) via unspecified route of administration on an unknown date at SINGLE DOSE for COVID-19 Immunization. The patients medical history and concomitant medications were not reported. He received the Pfizer Covid-19 vaccine last Thursday or Friday of last week and a day or two after he has been experiencing pain and sensitivity on the right side of his gums, which is the same side where they administered the vaccine. The outcome of the event was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Scattered petechial spots in both legs with thrombocytopenia with platelets count of 91000.; Scattered petechial spots in both legs with thrombocytopenia with platelets count of 91000.; This is a spontaneous report from a contactable consumer. A 60-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number ER8737, on 02Apr2021 13:00 at single dose in left arm for COVID-19 immunization. Medical history included myocardial infarction, hyperthyroidism, allergy to Contrast agent. The patient was not diagnosed with COVID-19 Prior to vaccination. The patient had not been tested for COVID-19 Since the vaccination. Concomitant medications included acetylsalicylic acid (ASPIRIN (E.C.)), clopidogrel bisulfate (PLAVIX), atorvastatin, pantoprazole sodium sesquihydrate (CONORAN), sertraline. The patient experienced Scattered petechial spots in both legs with thrombocytopenia with platelets count of 91000 on 13Apr2021. The outcome of the events was unknown.

Patient stated Left Arm was very sore after first Pfizer Covid-19 dose, extending up his neck on the left side. He stated arm was still sore at time for second shot (5/17/2021). Patient opted to have SECOND Covid-19 shot given in RIGHT ARM. He also experienced a couple of days having nausea, vomiting, and diarrhea, concurrently. Patient complained that his Psoriatic Arthritis became aggravated also after the first shot also. Pharmacist askedif he wanted the second Pfizer Covid-19 vaccination and patient stated he did. Pharmacist administered the second shot in the series in the other arm (right) from the first shot (left). Patient was asked to remain for 30 minutes, which he did, then left stating he felt fine.

High fever, Nausea, joint pain, body aches, fatigue, vomiting, red spots all over body. Injury to kidney and liver

Patient had high fever of 101.5 with body aches, headaches, rash all over body for 4days. Injured kidney and liver through lab test

This was for the first COVID shot, A few days afterwards, I got a significant rash on my lower legs and ankles. Rash continued until my second vaccine on 05/03/2021. After I took the second vaccine, the rash subsided on my legs but came back strong on my upper arms, back and neck. I have been taking Benadryl and applying hydrocortisone to treat the itching.

Site: Pain at Injection Site-Mild, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Systemic: Abdominal Pain-Mild

Per triage notes on 4/21/21: Pt had his 2nd COVID vaccine today at 0800. At 0900 developed lip swelling. Took two doses of Benadryl and has now developed chest tightness and throat swelling. Per doctor's notes: Patient is a very pleasant 60-year-old gentleman who comes in for evaluation after a possible allergic reaction today, possibly related to a second dose of Pfizer Covid vaccine that he got at 8 AM this morning. About an hour later he started to feel flushed. He felt like his face was warm and his ears were warm. He started to feel like the inside of his mouth had filled with a rubber ball. His tongue felt full and he started noticed progressively that he felt like he was having difficulty swallowing. States that he never actually had any lip swelling, contrary to the triage note, just felt funny in the interior of his mouth. Did feel like his tongue was slightly swollen, both based on the fact that it felt "thick" when he was talking, and on direct inspection, as well. Took 50 mg of Benadryl around the time that his symptoms started, and lay down to nap for a little while. When he woke up he was still feeling like he was having more difficulty swallowing. He also felt like his face was a little bit puffy, prickly under each eye. He also felt like he had a blotchy rash on his chest and upper back, which his wife corroborates. He felt like his chest was a little bit tight and that something was heavy on his chest, though he was not wheezing or acutely short of breath, per se. Took another 50 mg of Benadryl at about 2:15 PM, and presented to the emergency department for further evaluation. Currently still has a little bit of chest tightness and throat tightness. He feels flushed. Symptoms have not worsened, but they have not completely resolved, either. He has had anaphylaxis in the past and has had to be admitted to the hospital. And this was in relation to taking doxycycline, it sounds like. Patient presented again to the ED on 4/22/21 with the same symptoms. He was admitted with anaphylaxis. Per ED notes, also diagnosed with Angioedema, improved. Likely related to second covid vaccine. Cant rule out secondary to Lisinopril.

Pain at injection site, sore muscles, headaches, painful and swollen lymph node on left side of neck under left ear -- still painful and swollen after 3 months since injection

Very painful left arm pain. location where shot was given there is a lump under the skin. The pain is still going on when raising my are or supporting weight on it. . My Fiancée also had the shot in her arm before I did and her arm as well is having site pain. She had the same shot that I did at pharmacy.

PT REPORTED OF MUSCLE PAIN THAT RADIATED FROM LEFT ARM (WHERE HE WAS GIVEN THE SHOT), TRAVELLING TO LEFT SHOULDER, THEN TO LEFT CHEST MUSCLE. INJECTION OCCURED AT AROUND 1140AM, PT REPORTED PAIN TO PHARMACIST AT 1151AM. WHEN I EXAMINED THE INJECTION SITE, THE AREA DIDN'T LOOK RED OR SWOLLEN. I CHECKED BP AT 1153AM AND IT WAS 152/81. I CHECKED BP AGAIN AT 12:10PM AND IT WAS 155/85. AT 12:10PM, PT WAS STILL REPORTING CHEST MUSCLE PAIN ON THE LEFT SIDE OF HIS TORSO. PT WAS ALERT AND WAS ABLE TO TALK TO ME.AND TELL ME HIS SYMPTOMS. EMT WAS CALLED AT 1214PM. 911 OPERATOR INSTRUCTED ME TO GIVE HIM 4 TABS OF 81MG CHEWABLE ASPIRIN (NDC 00904-4040-73) AT 1231PM. EMT ARRIVED SOON AFTER. PT WAS TAKEN TO HOSPITAL AT AROUND 1245PM.

Fever; chills; headache; muscle aches; joint pain; fatigue; pain in injection area; This is a spontaneous report from a contactable consumer (Patient). A 60-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number and Expiration date was not reported), via an unspecified route of administration, administered in Arm Left on 05Mar2021 12:15, as single dose for COVID-19 immunization. The patient's medical history included hypertension. The patient had COVID-19 prior vaccination. Concomitant medications included chlorthalidone, hydralazine and losartan potassium. On 06Mar2021 08:00 AM, the patient started experiencing fever, chills, headache, muscle aches, joint pain, fatigue and pain in injection area. No treatment was received in response to adverse events. The patient was not COVID tested post vaccination. The outcome of the events was reported as not resolved. No follow-up attempts are possible. Information about lot/batch number cannot be obtained.

urticaria (hives) or drug eruption; urticaria (hives) or drug eruption; disrupting sleep; allergic reaction to COVID vaccine; Severely swollen left hand; rash bounced between hands and feet/ Rash kept moving randomly around all over body; Itchy rash inner left arm/ itchy rashes on left palm; Lump on left arm at injection site; This is a spontaneous report from a contactable consumer (patient). A 60-year-old male patient received second dose of BNT162B2 (Lot Number: EW0153), via an unspecified route of administration, administered in left arm on 13Apr2021 at age of 60-year-old as single dose for covid-19 immunisation. The patient received first dose of BNT162B2 (Lot Number: ER2613), via an unspecified route of administration, administered in left arm on 19Mar2021 at age of 60-year-old as single dose for covid-19 immunisation. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. No any other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. On 15Apr2021 (Day 2), patient had lump on left arm at injection site. On 16Apr2021 (Day 3), itchy rash inner left arm. On 17Apr2021 (Day 4), itchy rashes on left palm. Over next few days rash bounced between hands and feet. On 21Apr2021 (Day 8), patient went to clinic for severely swollen left hand. They almost cut off wedding ring. Tested for Limes Disease. Next major swelling and rash traded between Rt hand, Left foot, Rt foot. At one point left fingertips felt burnt. On 29Apr2021 (Day 16), family doctor told the patient Lyme disease test was negative. Doctor suggested he was having allergic reaction to COVID vaccine. Rash kept moving randomly around all over body, disrupting sleep. Took antihistamines Benadryl, Loratadine and used steroid cream. On 04May2021 (Day 21), dermatologist took skin sample from rash to test. Rash continued. On 19May2021 (Day 36), dermatologist said test suggests urticaria (hives) or drug eruption. Told me to take 4 Loratadine, 2 Benadryl, 1 Pepcid. Rash almost totally disappeared (4 days ago). Supposed to continue regimen for two months. The adverse event resulted in Doctor or other healthcare professional office/ clinic visit, emergency room/ department or urgent care. The outcome of events was recovering. Follow up needed, further information has been requested.

Developed Shingles. Diagnosed by Primary Care provider; This is a spontaneous report from a contactable consumer, the patient. A 60-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number- UNKNOWN) via an unspecified route of administration in left arm on 02Mar2021 at 14:30 (at an age of 60-years-old) as single dose for COVID-19 vaccination. Medical history included heart disease, unspecified from an unknown start date and unknown if continuing. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Patient didnt have any allergies to medications, food, or other products. The patient didnt receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included AVODART, Statins (MANUFACTURER UNKNOWN), Blood pressure medicine (MANUFACTURER UNKNOWN); all taken for unknown indication from an unknown start date and unknown if ongoing. On 10Mar2021, the patient developed Shingles. Adverse event resulted in doctor or other healthcare professional office/clinic visit. Treatment received included famciclovir (MANUFACTURER UNKNOWN) taken for Shingles from an unknown start date. The clinical outcome of Shingles was not recovered. Information about lot/batch number cannot be obtained. No further information is expected.

Sore arm at injection site; This is spontaneous report from a non-contactable consumer, the patient. A 60-years-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch number: Unknown), via an unspecified route of administration and in unspecified anatomical site on 10Mar2021 (at the age of 60-year-old) as a single dose for COVID-19 immunisation. Medical history and Concomitant medications were not reported. Patient was not allergic 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. On an unspecified date in Mar2021, the patient experienced sore arm at injection site. The patient did not receive treatment for the event. The clinical outcome of the event sore arm at injection site was resolving at the time of report. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

arm was sore after receiving the Covid-19 Vaccine; This is a spontaneous report from a contactable consumer. A 60-years-old male consumer (patient) reported for himself that he received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EN6203; NDC number and expiry date were reported as unknown) via an unspecified route of administration on 09Mar2021 in left arm as a single dose for covid-19 immunization. Medical history, other products, investigation assessment and concomitant medications were not reported. On 10Mar2021, in the morning the patient reported that his arm was a little sore after receiving the Covid-19 Vaccine. He received the vaccine in his left arm, and he was left-handed. He also received a flu shot. The patient does not have the physician email address or address to provide, and he was going for a physical tomorrow. He stated that his aunt (96-years-old) got the first dose of vaccine a couple of weeks ago and also got the second dose. She was fine and her arm was not even sore like his arm. The outcome of the event was not recovered. No follow-up attempts are possible. No further information is expected.

At approximately 1102 (15 min after vaccine admin) pt c/o generalized itching without rash, headache and fatigue. Denied any difficulty breathing or swallowing. BP 163/99, HR 65, O2 95%, RR 16 (pt notes baseline hypertension). Attending provider, Dr. (Name), notified of pt's symptoms, bedside assessment performed, 50mg Benadryl IM ordered and given at 1110. At approx. 1120 pt c/o intermittent chest pain, describes as stabbing, and mild difficulty swallowing. BP 186/100, O2 96%, HR 74, RR 16. Provider updated, continued to monitor. At approx. 1125 pt notes increased itching, BP 161/103, HR 59, 02 97%, HR 18. Pt assisted to supine position with HOB elevated. Continued to deny difficulty breathing. Approx 30 min admin of Benadryl pt noted initial improvement of itching, BP 173/93, HR 58, O2 96%, RR 18. After approx. 1 hr after vaccine admin pts states symptoms mostly resolved, bedside assessment performed by Dr. (Name), pt cleared for d/c home.

Severe shoulder pain vax site spreading to other shoulder. Numbness right side of face. Large swelling left shoulder below vaccination site.

Burning sensation started on back of neck - intense sunburn feeling. Later on arms, hands, feet and back. Also pins and needle feeling. Started taking Advil and Benadryl. Helped a little. Moved to Advil and Zyrtec during the day. The intensity varies during the week. To a little sunburn feeling to more intense on other days. Been doing on for two months now.

Commencing approximately 18 hours after the vaccination (which was my second Pfizer vaccine), I developed a rash that started under my arms and on my lower abdomen. Within approximately 4 hours the rash had spread across my chest, up my neck to the chin, around my waist and up the center of my back, and down the insides of my arms. The rash remained inflamed and red, and the skin sensitive, for approximately 72 hours before it began to fade. Within 5 days of beginning, the rash had subsided completely.

Patient hospitalized for cellulitis and possible septic elbow within 6 weeks of receiving COVID vaccination.

1st dose of vaccine administered on 03/25/21 at 1:30 pm. Side effects: 03/25/21-03/28/21 ? pain on the site of injection; nausea. 03/26/21-04/04/21 ? increased tone of facial muscles; tiredness. 04/05/21-04/07/21 ? stomach pain; slight increase in body temperature up to 37.2 C; nausea; vomiting; muscle and joint pain in the belt region. 04/08/21-04/12/21 ? increased maximum body temperatures up to 37.8 C; temperature declined overnight to 36.7-37.2 in the morning and then rising again; change of voice; all other side effects are gone. 04/13/21-04/14/21 ? maximum body temperature decreased to 37.4 C; change of voice. 04/15/21-04/20/21 ? maximum body temperature decreased to 37.2 C; change of voice. 04/20/21 blood test results - inflammation: Erythrocyte Sedimentation Rate (ESR) 56 mm/hr SARS-CoV-2 Antibodies, Spike Protein 15.10 U/mL C-Reactive Protein (CRP) 1.06 mg/dL 04/21/21-05/08/21 ? maximum body temperature decreased to 36.7-37.0 C; change of voice persists; chest pain. Multiple rectal bleedings: 04/30/21, 05/01/21, 05/11/21, 05/12/21, 05/15/21, 05/16/21, 05/21/21, 05/22/21, 06/03/21, 06/04/21(small). Temperature is in the normal range since 05/09/21. 06/01/21 blood test results ? inflammation gone: Erythrocyte Sedimentation Rate (ESR) 10 mm/hr SARS-CoV-2 Antibodies, Spike Protein 10.10 U/mL C-Reactive Protein (CRP) 0.44 mg/dL Looking for suggestion to do or not to do second vaccine administration.

Elbow and ankle joint pain; Skin tenderness; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN 6205) via an unspecified route of administration in the left arm on 07Mar2021 at 12:00 (at an age of 60-year-old) as a single dose for COVID-19 immunisation. The patients medical history included acid reflux, Chronic obstructive pulmonary disease (COPD), Kaposis sarcoma and unspecified allergies. The patient was allergic to nonsteroidal anti-inflammatory drug (NSAID). Concomitant medication included omeprazole (MANUFACTURER UNKNOWN) for an unknown indication. Prior to vaccination, patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Since the vaccination, has the patient was not tested for COVID-19. On 09Mar2021 at 09:00, the patient experienced elbow and ankle joint pain and skin tenderness. 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 elbow and ankle joint pain, skin tenderness was not resolved at the time of this report. No follow-up attempts are needed. No further information is expected.

Injection site pain; This is a spontaneous report from a contactable consumer or other non hcp (reporters father). A 60-years-old male patient received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number unspecified, expiration date unspecified), via an unspecified route of administration on 26Mar2021 as DOSE 1, SINGLE for covid-19 immunization (60 year at the time of vaccination). The patient medical history and concomitant medications were not reported. On 26Mar2021, the patient experienced injection site pain. And the reporter wanted to know if the patient can take Tylenol/ibuprofen. The outcome of the was reported as unknown at the time of report. No follow-up attempts are possible. No information about lot/batch number cannot been obtained.

Extreme muscle pain, chills, headache over right eye, fatigue, nausea, arm soreness at injection x 24 hours

Persistent swelling, hives, anaphylaxis (over 30 days). Able to suppress with prednisone 20mg daily. No long-term solution yet

On June 29, 2021, 47 days after the 2nd injection of Pfizer-BioNTech COVID-19 Vaccine EUA, a sever skin rash or hives occurred over the entire body and has persisted for a week now. Sever swelling of facial tissues, especially the lips and cheeks has required treatment of Prednisone 40 MG per day to reduce swelling, this prescribed by order on July 1, 2021. This has never occurred before in this individual and there has been no other known cause for this condition. There are no known food allergies or other allergies know to cause such a reaction in the history of this patient and no event, insect sting, bite or unusual exposure to any allergen has been found to have occurred.

June 2021- painful left ear lobe, erythema and abscess, treated at home with warm compresses, lanced small abscess, topical triple antibiotic ointment resolved in 1 week June 2021 - 1 week later - painful right ear lobe, erythema and abscess, treated at home with compresses, lanced small abscess, topical triple antibiotic ointment resolved in 1 week. June 2021 - 3 weeks later - redness on right side of neck at the collar line extending from the angle of the mandible to chin associated with a large grape-sized lesion. Treated with warm compresses, 2 weeks of Keflex, currently on Bactrim

A day after the vaccine, I started itching , the itching was localized to arms and soon to my back. Having allergies , I started on my OTC medications to include Hydrocortisone cream . As the days progressed, the rash was over my entire body to include swelling of face and legs.

An evident RASH on the torso, flanks, shoulders, of various sized spots. Sizes of pea size and pencil size and a little larger. They aren?t symmetrical in shape. They are red pink hue and within each rash bump then it looks like a mottled bumpy pattern within each rash-bump. He Still has the rash and it is currently July 11th 2021, as I type this. The rash is worse in the right abdomen than it is elsewhere. The rash is slightly lessened or lightened up on the left abdomen. We?re hoping that it eventually goes away or lessens greatly. It?s Not an totally adverse effect as it is minimal in effecting me, yet I would like to know IF I should attempt to get next year?s vaccine from a different manufacturer in hopes that it?s chemical makeup is slightly different and then it may not, provide a body rash. We have seen pictures of other people online that got same exact abdomen rash, just like mine from their vivid vaccine.

skin irritation.; felt like a pulled muscle under my left rib cage about 1 hour after the shot. Thought I just pulled a muscle some how but the next day I sneezed and the pain was incredible.; I'm in severe pain.; cough; sneeze; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732, Expiration date: Not reported), via an unspecified route of administration, administered in right arm on 26Mar2021 18:30 (at the age of 60-years-old) as DOSE 1, SINGLE for covid-19 immunization. Medical history included diabetes, asthma, glaucoma, tinnitus, Known Allergies: raw apples make my mouth itch. Concomitant medication(s) and received within 2 weeks of vaccination included solifenacin, losartan, tadalafil, atorvastatin. The patient had allergies with raw apples makes mouth itch. The patient had no other vaccine within four weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient filed this information in the initial report but got the vaccine on 26Mar2021 Friday and maybe 1-2 hours after that he thought he pulled a muscle somehow under his ribcage area and the next day on Saturday he still felt it but it was not a big deal. States then he sneezed while he was driving his car and almost crashed and the pain was incredible and was one of the most painful things he has had happen. States he couldn't believe this and then when he went home and bought Salon Pas which are those heat things that heat up and he is using so many of them but they are causing skin irritation. States he went to the emergency room on Monday but according to him people showed no interest and was not quite alarmed of the situation even though they do not know what is it specifically. His physician, prescribed him with the cough syrup because if he coughs or sneezes was when it really really hurts him and hurts more when he sneezes and oxycodone for the pain which he didn't took. He also mentioned that physician requested for a CAT Scan which didn't show anything on the results Normal. He is also scheduled for his second shot tomorrow. The adverse event resulted in emergency room/department or urgent care visit. The patient did not receive any treatment. Outcome of the event skin irritation was unknown, while that for other events was not recovered, at the time of this report. Information about lot/batch number cannot be obtained. No follow-up attempts are needed. No further information is expected.

injection site pain.; fever; entire body joint pain; muscle pain; This is a spontaneous report from a contactable other health care professional, the patient. A 60-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6199) via an unspecified route of administration in the left arm on 25Mar2021 at 19.00 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history included hyperlipidemia. Concomitant medications included simvastatin (MANUFACTURER UNKNOWN) 20mg on every other day for an unknown indication and from an unspecified date. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6200) via an unspecified route of administration in the left arm on 04Mar2021 at 19.00 (at the age of 59-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 had not received any vaccines within four weeks prior to the COVID-19 vaccine. On 26Mar2021 at 15:00, the patient experienced injection site pain, fever, entire body joint and muscle pain. No therapeutic measures were taken as the result of adverse events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care 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 vaccination site pain, fever, body joint pain and muscle pain was resolved on an unknown date in Mar2021. No follow-up attempts are needed. No further information is expected.

Site: Pain at Injection Site-Medium, Additional Details: Patient does not have full mobility of left arm. Cannot lift above head

Shingles flank pain followed by typical left flank rash with resolution over 4 week time course. Neurasthesias resolved over 7 weeks

Patient developed Bell's Palsy, about 2 days after getting his pfizer vaccine. Patient also developed hookworms. Patient has visited several doctors, and had prescriptions for hookworms. Patient is still having pain from rashes, and he state that his sturnum had popped out and the rashes have affected his groins.

Woke up small area of inflamation burning on right index finger. Seems to have developed into a small area of shingles. I had chicken pox as a small child. Affected area has calmed down and skin is peeling mildly and I seem to be recovering.

Small patch of itching that bounced all over body (one single cell at a time), would go away for days at a time.

A few days after my second Covid vaccination I started experiencing fatigue, dizziness and shortness of breath. I also noticed the calf muscle in my lower right leg began to swell. The swelling continued to get worse and about a week later I noticed a significant amount of petechial hemorrhaging in my lower right leg. I started using an ice-pack in an attempt to reduce the swelling. I also sat/lay with my leg up (horizontal) as much as possible. On 6/28 I visited with my primary care doctor to seek help in addressing the swelling. My doctor sent me for an ultrasound which discovered a deep-vein thrombosis (DVT) and a CT scan which highlighted pulmonary embolisms in my lungs. I was admitted to hospital where I was treated with blood thinners; Note: I had my first shot on 4/13/21 and also experienced fatigue, dizziness and shortness of breath, but did not experience any swelling. As a result of feeling unwell I delayed getting my second shot.

three additional spots about 1/2 inch in diameter appeared; skin rash /bump appeared on my right wrist; skin rash / bump appeared on my right wrist and was very itchy; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via an unspecified route of administration in the right arm on 12Mar2021 at 17:00 (at the age of 60-years-old), as a single dose for COVID-19 immunisation. The patient had no medical history and did not take any concomitant medications. 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 4 weeks prior to the COVID vaccine. On 30Mar2021 at 12:00, the patient experienced the first skin rash / bump that appeared on the right wrist and was very itchy. It expanded to an area about 1 inch x 2 inches and a week later continued to be itchy. On 04Apr2021, three additional spots about 1/2 inch in diameter appeared on and around the patients right nipple and later that day, three other spots about 1/2 inch in diameter appeared on his left shoulder. The chest and shoulder spots were only slightly itchy. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken for the events skin rash and itchy rash and included treatment with Zyrtec which helps reduce the itching. The patient reported that he only takes 1/8 of a pill (Zyrtec) because a whole pill was too strong for him. The clinical outcome of the events skin rash / bump that appeared on the right wrist and was very itchy and three additional spots about 1/2 inch in diameter on and around the right nipple and on the left shoulder was recovering at the time of this report. No follow-up attempts are needed. No further information is expected.

Swelling in left arm that has not gone away since vaccination. Location at bottom of bicep. tender and sore

Patient contracted COVID-19 after receiving two COVID-19 vaccine doses (Pfizer series completed on 4/30/21). Patient presented to ED on 7/25 c/o rash on his back, feeling generalized fatigue and weakness for last few days and had tested positive for SARS-CoV-2. Patient remained stable and was discharged from ED on same day. On 7/29 patient returned c/o headache and SOB, he was placed on 3.5L NC and given albuterol neb, acetaminophen and prednisone.

Right side of face tingly, slightly numb. Tingly feeling was gone the next day. Slightly numb feeling lasted at least three or four days. Right arm was sore for four days. Until 12/28, pain in upper right arm would start for no reason, usually in the evening.

itch on inner thighs bilaterally/raising up both groins and onto my flanks/risen up to the level of my ribs and around my back/rose up onto both arms/itching was down to my forearms and hands; developed an itch on my inner thighs bilaterally. Scratching produced raised welts; This is a spontaneous report from a contactable nurse, the patient. A 61-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: EH9899, via intramuscular on 22Dec2020 at 07:00 (at the age of 61 years old) as a single dose in the left arm for COVID-19 vaccination. Medical history was none. Prior to the vaccination, the patient was not diagnosed with COVID-19. No known allergies. Concomitant medication included amoxicillin, unspecified multivitamin, triple omega, turmeric, and ibuprofen all for unknown indications from unknown dates and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The vaccine was given at a hospital. On 23Dec2020 at 20:00 he developed an itch on his inner thighs bilaterally. Scratching produced raised welts. He treated with cortisone cream and went to bed. At about 3AM he woke up with more itching. The itching was raising up both groins and onto his flanks again bilaterally. At 5AM when he got up for work it had risen up to the level of his ribs and around his back with minimal itching on his thighs where it started. As the day progressed the itching rose up onto both arms as the itching subsided in the lower areas. He took a benadryl 25 mg that night to sleep. By the next morning (72 hours post injection) the itching was down to his forearms and hands. These symptoms were mostly resolved at this point with some minor itching of my hands. The clinical outcome of 'developed an itch on my inner thighs bilaterally. Scratching produced raised welts' was recovered, and 'itch on inner thighs bilaterally/raising up both groins and onto my flanks/risen up to the level of my ribs and around my back/rose up onto both arms/itching was down to my forearms and hands' was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.

Myalgia & Diarrhea Narrative: Per employee, 14 hours after vaccination, felt abdominal cramps followed by watery diarrhea and sore left arm (vaccine site). No hx of changes in food prep nor diet 1/1/2021. Denied fever, some sniffles (chronic) diarrhea improving bowel movement mid morning following day

Upper lip swelling on date of vaccination 1/5/21 starting on 1/8/21, developed severe generalized urticaria - still active

The patient reported the development of rash to trunk and neck as well as itching the day after the COVID19 vaccine was given.

headache, chills, injection site pain, feeling unwell, difficulty breathing, dizziness, weakness and imbalance

Mildly feverish evening after vaccine; Soreness and tenderness at left arm injection site; This is a spontaneous report from a contactable physician (patient). A 61-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; second dose (lot number: EL1284, expiry date: unknown) via an unspecified route of administration on 07Jan2021 07:00 at single dose (Left arm) for COVID-19 immunization. Patient took bnt162b2 first dose (lot number: EK5730, expiry date: unknown) on 17Dec2020 07:00 am (Left arm) for COVID-19 immunization. Medical history included known allergies: Sulfa, Hypothyroid, Asthma, Hi Cholesterol. Concomitant medication included cetirizine hydrochloride (ZYRTEC), atorvastatin, levothyroxine. The patient previously took tamiflu and experienced allergies. Facility type vaccine was hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced Mildly feverish evening after vaccine, Soreness and tenderness at left arm injection site on 07Jan2021. The patient took Motrin as treatment. Therapeutic measures were taken as a result of mildly feverish evening after vaccine, soreness and tenderness at left arm injection site. The outcome of the events was recovered on an unspecified date. The events were reported as non-serious.

Developed Herpes Zoster on R chest about one week after second injection. Minor pain, taking ibuprofen only, no antivirals. Shared picture with Doctor and he agreed.

Some injection site soreness; Joint pain; Muscle aches; A little temporary nausea; This is a spontaneous report from a non-contactable consumer. A 61-years-old male patient started to receive received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number FL1284, via an unspecified route of administration on14Jan2021 09:00 at SINGLE DOSE for COVID-19 immunization. Vaccine location: Left arm Medical history included cardiovascular disorder, colitis ulcerative and depression. Concomitant medication included aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]), colecalciferol (D3), fluoxetine (FLUOXETINE), mesalamine (MESALAMINE), rosuvastatin calcium (ROSUVASTIN), ubidecarenone (COQ10 [UBIDECARENONE]). On 14Jan2021 19:00, patient experienced injection site soreness with outcome of recovered, joint pain with outcome of recovered, muscle aches with outcome of recovered and a little temporary nausea with outcome of recovered. The action taken was not applicable. No follow up attempts are possible. No further information is expected.

All residents had been in isolation due to multiple cases of COVID in the facility. Resident voiced no health related complaints. He continued to visit with staff and required moderate assist with toileting. Resident had fall 0130 on 1-15-2021, which resulted in laceration with surgical repair. Resident was noted to change in mental status and respirations on morning of 1-16-2021 during morning blood sugar check. Resident had O2 @1.5l/m via n/c and respirations of 10 with periods of apnea and unresponsive to verbal stimuli. Blood sugar was 583. Resident deceased upon re-check after calling PCP to report status change.

Developed facial shingles, mandibular branch of the trigeminal nerve, right face beginning 1/25/2021. Treatment begun by Dr.(not the administer of the vaccine) includes Valtrex 1gm tid x 10 days; this was begun 1/28/2021. Evaluated by Dr. to r/o eye involvement (negative exam).

Injection site pain, Tiredness, Headache, Muscle cramps & pain, Chills, Joint pain (extreme), Fever, Feeling Unwell.

I was asked to sit down for 15 mins in the observation chair. I started to feel a warm feeling in the arm went back to work.The next day arm was sore at the injection site went away that night. On Friday night started vomiting and diarrhea at the same time.After 3 days following Monday I went to ER stayed 2 wks 12 days with blockage small intestine.

felt like he got the vaccine in his arm again and it was going into his shoulder/ arm felt achy like it was the day he got the shot and the day after; felt like he got the vaccine in his arm again and it was going into his shoulder/ arm felt achy like it was the day he got the shot and the day after; achy arm; This is a spontaneous report from a contactable consumer (patient himself) via Medical Information team a Pfizer-sponsored program, Pfizer First Connect. A 61-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection; batch/lot number and expiration date were unknown), via an unspecified route of administration on the left arm on 12Jan2021 at a single dose for COVID-19 immunization administered at the hospital. The patient received his first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, batch/lot number and expiration date unknown) on 22Dec2020. Relevant medical history included high blood pressure and diabetes; both were diagnosed in 2006 and ongoing conditions and were under control. Concomitant medications included metformin, lisinopril for high blood pressure, and semaglutide (OZEMPIC, injection), which was a once a week injection kind of like "Trulicity" that encourages his body to make more insulin. The patient said that when he got the second dose of the vaccine on 12Jan2021, he got an achy arm and it went away. At the time of the report on 18Jan2021, almost a week later, he felt like he got the vaccine in his arm again and it was going into his shoulder. The patient was asking if it was normal. He was driving at the time of the call. The patient had been a scrub technician (tech) and an endoscopy tech for 20 years. During the first surge, when they shut down the outpatient surgeries, he went and worked as an aide in the COVID ward. He was glad to get the shot. He did what his kids would do when they were young and would get a shot. He took ibuprofen. Later that evening for the achy arm, he took more ibuprofen. The achy arm lasted only a day. He thought he wasn't going to have any side effects at all. It felt like a flu shot. The patient clarified that at the time of the report (18Jan2021), his arm felt achy like it was the day he got the shot and the day after. He got the vaccine as he was in the first bunch in the city and he works in healthcare and the fact that he was over 60 years old. The patient stated he could live through it and he was just curious. The reporter assessed the events as non-serious. The events did not require any visit to an emergency room or a physician office. The patient had no relevant tests. Therapeutic measures were taken as a result of achy arm, which included ibuprofen. The patient recovered from the event "achy arm" on 13Jan2021, while the outcome of the event "felt like he got the vaccine in his arm again and it was going into his shoulder/ arm felt achy like it was the day he got the shot and the day after" was unknown. Information on the batch/lot number has been requested.

hives; anxious; This is a spontaneous report from a contactable other healthcare professional. A 61-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) intramuscular at the right leg on 25Jan2021 (lot number EN5318 and expiry date unknown) at single dose for Covid-19 immunization in a nursing home/senior living facility. Medical history included COVID prior vaccination. The patient's concomitant medications were not reported. The patient had no other vaccine in four weeks. On 25Jan2021, the patient experienced hives and was anxious, the patient was taken to the hospital. The events resulted in emergency room/department or urgent care. The events caused hospitalization on 25Jan2021. The outcome of the events hives and anxious was unknown.; Sender's Comments: Based on the very close temporal association, there was a reasonable possibility that the vaccination with BNT162B2 played a contributory role in triggering the onset of the urticaria and anxiety. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Patient stated that they had quite a bit of pain in his shoulder, had some bruising that spread down his arm, and what looked like red blood vessels visible on his right shoulder. He had no pain for the first injection. This occurred about a month ago, but the patient is still experiencing intermittent pain/soreness on and off.

RECEIVED PFIZER VACCINES ON 01/08/21 & 01/29/21. 02/05/21 SAW PCP IN OFFICE REGARDING NEW RT ARM REDNESS/PAIN. X2 DAYS. DX: CELLULITIS 02/09/21 WENT TO ER TO REPORT WORSENING ARM REDNESS R/T CELLULITIS. REFUSED INPT TREATMENT ABX AND WAS DISCHARGED ON ORAL ABX. 02/12/21 RETURNED TO ER FOR WORSENING ARM CELLULITIS DESPITE ORAL ABX. ADMITTED FOR DX SEPSIS AND CELLULITIS.

Severe rash still 9 days after injection. Got steroid injection 4pmon the 02/13/2021 and have so far taken 4 of 5 pillsof a series of METHY1PREDN Solone 4mg dose pack

Hives, Itchiness, Difficulty Breathing Benadryl and later when difficulty in breathing increased an Epipen Administered Symptoms Reduced, no further issues

the swelling and extreme tenderness of the site of injection; the swelling and extreme tenderness of the site of injection; headache; I couldn't sleep last night because I have headache, thrombing headache and back pain; Nausea; I had like metallic taste; Dizziness; The initial case was missing the following minimum criteria: suspect drug. Upon receipt of follow-up information on 27Jan2021, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable physician. A 61-year-old male patient received his first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EJ1685, expiration date Mar2021) on his left arm, intramuscular on 18Dec2020 at 0.3 mL, single for COVID-19 immunization. Medical history included hypertensive, 2 stents in heart in 2016, Hyperlipidemia, hypothyroidism, coronary artery disease in 2016 and Allergic (Allergic rhinitis + Chronic sinusitis). Concomitant medication included acetylsalicylic acid (ASPIRIN), clopidogrel bisulfate (PLAVIX). It was reported that the patient had swelling and severe tenderness left his arm. He couldn't sleep last night because he had throbbing headache and back pain on 18Dec2020. Initially, he had nausea. Patient stated further stated that Headache and swelling and extreme tenderness of the site of injection, that is the swelling, no redness but the swelling and tender and painful. Initially, he had till now the mild back pain. He patient said she took Tylenol. She also mentioned that initially she had like metallic taste and then disappear. The patient also had dizziness a little bit. The outcome of the event vaccination site swelling, dysgeusia and tenderness was recovered on unspecified dates, headache and back pain was not recovered, recovering for nausea while unknown for the remaining events.

pt noticed a couple days after getting the vax he developed itchy hives on arms and legs that come and go. States he takes Benadryl before he goes to bed. He also had swelling in his lips that come and goes. Pt has not contacted his PCP at this time.

This is a spontaneous report from a contactable consumer (patient). A 61-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration on 02Feb2021 08:45 at single dose for COVID-19 immunization. Medical history included stage 4 prostate cancer. 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. Since the vaccination, the patient has been tested for COVID-19. Concomitant medications were not reported. The patient previously took celecoxib (CELEBREX) and experienced allergies. On 04Feb2021, the patient experienced extreme soreness on side where injection was given, also had malaise and tiredness. The patient underwent lab tests and procedures which included SARS-COV-2 test: unknown results (COVID test result Pending) on 05Feb2021. No treatment was received for the adverse events. Clinical outcome of the events was recovered/resolved with sequel (reported as recovered with lasting effects). Information on the lot/batch number has been requ

Pain in left arm was so strong that I could not roll over to get out of of bed. All other joints and areas in which I have minor aches and pains were very sore. Mind somewhat clouded. Modest temperature, 101. Chills. Like a bad flu, but more pain and less congestion. Strong but not splitting headache. Not like a migraine--not at all as bad. Very minor nose congestion and sore throat. Symptoms all ended by 36 hours after 2nd shot

Shoulder Pain starting 48+ hours after injection. Initial arm soreness went away in less than 24hours. At time of injection the shot was given high on my shoulder and sent pain through my back an up my neck. The shot was administered into my shoulder not my muscle This is problem from the injection not the vaccine. SIRVA type injury

Hospital course 1/31 ? 2/20/21 1/31 in ED pt was at home when children noticed his lips were blue, ems arrived and found him to be 50% on RA, on Non-rebreather pt got to 78%, covid on 01/26 Shortness of Breath 61-year-old male presents with EMS for evaluation of shortness of breath hypoxia. History is limited due to the patient's current clinical condition and so is primarily obtained from EMS. EMS reports that he tested positive for COVID-19 5 days ago. He began developing shortness of breath yesterday and his family called because his lips and fingers were blue today and he appeared short of breath. On EMS arrival he had a room air saturation of less than 50% so he was placed on nonrebreather with improvement in his saturation to 70% and he was transported to the emergency department. Patient does admit to shortness of breath. He denies any chest pain. He is noted to have a cast on his left ankle and said that he broke his left ankle on 23 December but has not had surgery. He denies any new pain or swelling of the leg. In the ED he was placed on 15L nasal cannula and NRB mask with improvement in SPO2 to low 90s. Additional work up revealed troponin of 1.35, lactic acid 5.8, and d-dimer 14.4. He received dexamethasone and was placed on heparin gtt. 1/31 admitted to ICU Acute hypoxic respiratory failure due to COVID-19 vs heart failure vs PE. CXR with bilateral hazy infiltrates more pronounced in the bases and left periphery and suspected multifocal pneumonia. At risk for PE given LLE immobility in the setting of COVID-19 with significantly elevated d-dimer. RISK of CTA outweighs benefit given AKI and iodine allergy. Continue with empiric treatment with heparin gtt. Admitted to ICU with SO2 in 60s-70s on 15L and NRB. Attempted 50L 95% FIO2 high flow and nasal cannula. Given lasix 40mg IV with good diuresis however SPO2 still remained low 80s with RR 40s and PO2 42 so the decision was made to intubate. Oxygenation improved following intubation, with further improvement following recruitment maneuver and increase in PEEP. FIO2 weaned to 90% with SPO2 remaining in mid 90s. Will continue to wean FIO2 as able. ARDS net protocol as much as possible. Consider prone ventilation and/or epoprostenol if unable to improve . VAP Bundle: HOB >30 degrees; Oral care per nursing standard and on DVT/PPI prophylaxis Sedation: Target Richmond Agitation and Sedation Scale (RASS) of 0 to -2 with propofol and fentanyl. Check baseline TG levels. COVID - 19: Convalescent plasma: Not indicated Steroids: Dexamethasone 6 mg / day for 10 days Remdesivir: Not indicated d/t AKI IL-6 inhibitor: Meets criteria for tocilizumab Systemic AC: Heparin gtt. No signs of bleeding (Platelets and Hb stable). Antibiotics: Start 3 and 7 day course of azithromycin and ceftriaxone, respectively. Elevated troponin Suspect demand ischemia d/t hypoxia; EKG does not show any ischemic changes AKI: Suspect d/t hypoxia in the setting of COVID infection. Urine output and electrolytes acceptable. Closed fracture of left ankle Suffered fracture following a fall on ice in December. Cast was placed on 12/30 by SOS. He was due to be re-evaluated this week for possible cast removal. Inhaled epoprostenol started Considered for ECMO but not initiated due to not a candidate Vasopressors required at times Antihypertensive infusion required at times severe hypoxia with position changes switched from heparin drip to enoxaparin prophylaxis 2/20 discharge summary 61 y/o male admitted to Hospital on 1/31 with hypoxia. He was diagnosed with COVID 19 5 days prior to admission, and had worsening respiratory status. He was intubated after arrival, and was on ventilator for the entire intervening time, until he was extubated on 2/20 at the time of transition to Comfort measures only. Prior to developing COVID 19, he had received his first dose of the Pfizer vaccine, as a member of the school system. He had a fractured L ankle after a fall on 12/31/20, and had a cast in place at the time of admission. He received Tocilizumab on 1/31, and underwent several cycles of prone positioning, beginning on 2/2. He completed a course of Decadron, he received Ceftriaxone and azithromycin beginning on admission, and completed a course of these. Anticoagulation with enoxaparin was utilized due to coagulopathy associated with COVID 19. Vasopressor support was required at times, as well as diuresis for fluid management. He required high levels of sedation to maintain ventilator synchrony, and high levels of ventilator support with high oxygen levels throughout his stay. Tracheostomy was being considered, but family decided that since he was not going to have good recovery, withdrawal of support, and allowing death was the appropriate choice for the patient and for them. He was extubated at 2100 on 2/20/2021. Death was pronounced at 2123 on 2/20/2021. Children were at bedside.

sore arm at injection site; tiredness; feeling unwell; loss of appetite; This is a spontaneous report from a contactable other healthcare professional (patient). A 61-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EL3247 and expiration date: unknown), via an unspecified route of administration on 02Feb2021 at 11:30 at a single dose for COVID-19 immunization. Medical history included likely COVID in Apr2020 based on a video call with his physician. Concomitant medications included celecoxib (CELEBREX), gabapentin (NEURONTIN), zinc (ZINC), aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]), ascorbic acid (VIT C), colecalciferol (VIT D3), and cyanocobalamin (VIT B12). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced sore arm at injection site, tiredness, feeling unwell and loss of appetite on 02Feb2021 at 18:00. Prior to vaccination, the patient was not diagnosed with COVID-19, and since the vaccination, the patient has not been tested for COVID-19. The events had not resolved.

Very tender area around injection site developed on second day and resolved about 36 hours later. Noticeable joint pain developed after 24 hours in shoulders, knees and hips. This resolved about 24 hours later. One instance of "Covid toe" developed on the small toe of my right foot about 48 hours after the vaccine. This has not yet resolved.

Headache, sore arm at injection, leg cramps - evening of injection >>> Blood pressure spike to 150/100 on second evening after injection, felt funny, bad sleep <<<

Warm red skin of face arms hands feet. Swelling in feet and hands. Trouble sleeping, anxiety, shaky. Prickly feeling throughout body.

Signs and Symptoms Painful bumpy, crusty, vesicular, and red rashes that looks like shingles. Patient was treated for Shingles.

significant swelling and redness at the injection site with minimal pain; significant swelling and redness at the injection site with minimal pain; significant swelling and redness at the injection site with minimal pain; weakness; Nausea; mild myalgia; general muscle pain and aches; This is a spontaneous report from a contactable physician (patient). A 61-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EK9231, expiry date: not reported), via an unspecified route of administration, on 28Jan2021 09:00 AM at a single dose on the left arm for COVID-19 immunization. The vaccine was administered at a hospital. It was not administered at a military facility. He did not receive any other vaccines within 4 weeks prior to receiving bnt162b2. The patient had no relevant medical history and concomitant medications to report.The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231, expiry date: not reported, NDC number: 59267-1000-1), on 09Jan2021 09:30 AM on the left arm for COVID-19 immunization, at the age of 61-year-old. He experienced myalgia at the injection site/pain at inject site after the first dose on 09Jan2021 and resolved on 12Jan2021. The first and second doses of bnt162b2 had the same lot number. On 28Jan2021, the patient received the second dose of bnt162b2. 24 hours later, on 29Jan2021, he experienced mild aches/pain, nausea/malaise. Three days (42-72hours) after 2nd dose, on 31Jan2021, he experienced "significant redness" and swelling at injection site with minimal pain. He described it as "Out of proportion to what should be expected". The redness and swelling were improving at the time of the report (01Feb2021). He asked if this should be of concern. He also asked if it was possible that the vaccine was given subcutaneously instead of intramuscularly. He developed a good amount of swelling and redness at the injection site. It seemed fine the first day. It took two or more days to develop the swelling. He added that he only had mild myalgia, weakness, and nausea initially on 29Jan2021 after the second dose of the vaccine. Then 48 hours later, he got the large amount of swelling and redness at the injection site. He later clarified he received the first dose of the Pfizer COVID 19 vaccine on 9Jan2021 at 09:30 AM in the left arm. He had some myalgia at the injection site on 09Jan2021 that went away on 12Jan2021. Then he received the second dose of the Pfizer COVID 19 vaccine on 28Jan2021 at 09:00 AM in the left arm. Initially he had no pain. 24 hours later, on 29Jan2021, he had myalgia referring to general muscle pain and aches and nausea that only lasted about two hours. He is mostly concerned now about the significant swelling and redness at the injection site with minimal pain which he noticed 48 to 72 hours after the second dose of the vaccine. He took some Aleve which gave some relief (for significant swelling and redness at the injection site with minimal pain). He asked if this is an expected side effect as it seem out of proportion to him. Outcome of events general muscle pain and aches and weakness was recovered on 30Jan2021. Outcome of event nausea was recovered on 29Jan2021. Outcome of events significant swelling and redness at the injection site with minimal pain was recovering. The reporting physician (patient) assessed the causality between the suspect vaccine and all events as related. He assessed the events "swelling and redness at the injection site with minimal pain" as medically significant (serious), while he assessed the other events as non-serious.; Sender's Comments: Based on temporal association and known product safety profile of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EK9231, expiry date: not reported), the contributory role of the product cannot be totally excluded. The events are known adverse event of the 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.

patient developed erythema at the injection site. he became nauseous and near syncopal. he then complained of chest tightness and DIB. Benadryl and two doses of epi given with no relief of symptoms. No facial swelling, wheezing, drooling, or hypotension. he was talking in sentences.

45 minutes after injection slight lip swelling and swelling in left cheek hei 's and years took 20 Tech and histamine and symptoms subsided in a few hours. *Important, 30 hours after injection the following night at 11:00 p.m. began to experience pronounced generalized Fasciculations - Similar to those I experienced After receiving the 3rd of 5 doses of the rabies vaccine in 2008. Strong , generalized muscular Fasciculations are now persisting 7 weeks after receiving the 1st dose of the Pfizer Covid vaccine.

Gout in my left foot at the base of the big toe has flared up. Some swelling and redness in the area, was warm to the touch when it started. Significant pain and lack of flexibility in the joint. Has persisted for four days.

Cold sweat at 2am Achy all over and especially upper joints Injection site sore Cannot get warm Slight intestinal discomfort

Client stated after receiving his vaccine he had shoulder pain leading from the injection site. Vital signs O2 sat 99%, BP 137/71, HR 78.

The injection site was painful for a couple of days and I had a red splotchy rash on my chest and neck the day after the vaccination

Fever (up to 101.6), body aches, nausea and headache peaking between 12-18 hours after dose, mostly resolved by 30 hours. Nausea, and headache persisted until about 30 hours (took Tylenol Extra Strength at 24 hours). Pain at injection site, could not sleep on that side. Gradually developed and peaked 12-18 hours after dosing. Still slightly sore at 30 hours.

Had shot on 2/17 and presented on 2/22 with significant red, 6cm rash on opposite arm - he had no prior history of eczema or skin condition. Symptoms resolved with topical steroid, but recurred again 3/9

Patient had his first covid vaccine at 1340 and within 10 minutes the patient's neck began to swell, turn red and he felt like he was having trouble breathing. Rapid response called in building, Epi pen administered, Benadryl 50mg IM administered and pt sent to hospital via 911 ambulance at 1418

Systemic: pt had blister at injection site -Severe, Additional Details: pt had hard ball at injection site and then blister appear and blister popped

Low fever 0.5 F above the normal, heart rate increased from 75/min to 110/min. Blood pressure 15 above the normal daily reading. coughs 3 to 4 times. Then, after 30 hours of the shot of vaccine, felt headaches. At that time, heart rate was closed to the normal. But had a couple of coughs. Just felt having a light flu at the beginning and tired. Pain on the shot area in the arm was not a concern. After 60 hours of the shot, feel good. Just report what I had.

I discovered bleeding like bruise; I discovered bleeding like bruise; This is a spontaneous report from a contactable consumer. A 61-year-old male patient received BNT162B2 (BNT162B2) via an unspecified route of administration, administered in Arm Left on 27Feb2021 at 12:00 (Batch/Lot number was not reported) as single dose for covid-19 immunization. Medical history included known allergies: penicillin. The patient's concomitant medications were not reported. The patient reported "I discovered bleeding like bruise in about 1 X 1 inches on my right fore arm" on 04Mar2021 at 14:30. Outcome of the events was unknown. Information about lot/batch number has been requested.

By 2nd day and for one week, had an extreme headache (unlike any migraine). Extreme flu like symptoms for 1 week after vaccination. Reports severe bruising on left arm from collar bone to elbow. "It was black".

Rash / hives developed on the inner left thigh. Itchy, red skin discoloration, small bumps with dime sized hives. Covers about a 9 inch by 3 inch area of skin.

Patient started with pain in his lower back thought it was muscle spasm .Kept working with the pain rash started still didn?t think anything about it March 29 he went to family doctor said it was a muscle spasm gave him muscle pills March 29 he was taken to the emergency room in excruciating pain emergency room doctor did test bloodwork CT scan urine sample came back that he has shingles he has the rash. His wife also had the same shot and she also has rash on her side no pain.Do not know if this has anything to do with the shots but wanted to report us because he never had it before he got the shot or neither did she

Blood Vessels in Right Eye; Eye is extremely red/eye is blood red; had a little soreness to injection site; This is a spontaneous report from a contactable consumer. A 61-years-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 14Mar2021 09:40 (Batch/Lot Number: EN6206; Expiration Date: 30Jun2021) as single dose for covid-19 immunisation. Medical history included ongoing hypertension. Concomitant medications included amlodipine besylate taken for hypertension from an unspecified start date (Started years ago) and ongoing. Patient states he took his Pfizer covid19 vaccine on Sunday morning. When he woke up on Monday morning there were some blood vessels in his right eye and his eye was extremely red. States that while he is uncertain of the exact time that this happened to his eye as he was sleeping; he noticed it Monday morning around 0700 when he woke up and looked in the mirror. States he had a little soreness to injection site, but nothing serious. Outcome of event eye red was not recovered, of others was unknown.

Injection site is sore, my body feel achy. 101.2 temp. It is down to 99.6 at 2:00 pm My joints feel like a dull pain.

Sore upper left arm at injection site has continued to current date. Especially painful in morning when getting up and moving about. Cannot sleep on left side without pain.

he is not getting any sleep; he had a rash and hives all over his body; itching; he had a rash and hives all over his body; sore arm; This is a spontaneous report from a contactable consumer reported for self. This 61-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 26Feb2021 in the morning on Arm right at single dose (Lot # EN6205) for COVID Prevention. Medical history included ongoing leukemia CML from 2013, ongoing chronic lymphocytic leukemia from 2013, prostate cancer, white blood cell count runs high anyway, PSA (prostate specific antigen) last time he had blood work done, was 5.1. Concomitant therapy was none. The patient received the first dose of the Pfizer-BioNtech Covid-19 vaccine on 26Feb2021 in the morning, in the evening (26Feb2021), he had a rash and hives all over his body, he also experienced sore arm. He states that he had itching sooner. He also has leukemia CML, his oncologist told him to receive the vaccine. He would like to know if he should receive the second dose of the vaccine, and get ready for rashes. He broke out in hives and it was really uncomfortable, and he was not getting any sleep. He states that the hives got so bad, it looks like he has alligator skin. He states that he took Benadryl (UPC: 81131 07825, Lot number: P113775, Expiry: Oct2020, he has been using the product since the expiry date) and used Cortisone, and it helped but did not work 100%, but it helped enough he got some sleep. He stated that he felt like it is getting better, but he was taking Benadryl, and when the Benadryl wears off, it starts doing it again, but it was bad at first, like alligator skin, so he does feel like it is improving some. Outcome of the event hives was recovering. Outcome of other events was unknown.

Pain at shot side so that arm not usuable for 12 hrs, chills for a few hours, extreme fatigue (slept twice normal amount) mild headache

Shortly after vaccination within 5 minutes. Patient complained of lips tingling and numbing. Patient was evaluated by EMS. A few hives found on center of chest. IM Benadryl and Pepcid given by EMS. Patient was monitored for 45 minutes and released.

Slight migraine headache, slight nausea, slight soreness on upper arm at injection site. Ibuprofen Lasted 2 days

Dizziness. Noticeable / moderate on 4/5/21 lying in bed and for hours after waking, slight on days prior. On morning after injection there was just some fatigue and soreness at injection site.

significant swelling at and around the site of injection, along with significant pain shortly after time of injection. Subsequent bruising. Bruising continues and has been increasing to this date (4.9.21) and the bicep and shoulder have a generalized swelling.

atrial fib; Short of breath; fatigue; Nausea; Dizziness; Unable to function; discolored; This is a spontaneous report from a contactable consumer(patient himself). A 61-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot/batch number not provided), via an unspecified route of administration, at Right Arm on 24Mar2021 12:30 (at age of 61 years old) at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced Short of breath, atrial fib, fatigue, nausea, discolored, dizziness, unable to function, all on 24Mar2021 14:00. Adverse event result in Emergency room/department or urgent care. No treatment received for the adverse event. The outcome of the events was not recovered. Information on the lot/batch number has been requested.

Outbreak of Shingles Physician prescribed 10days of Gabapentin Valtrex 17 days after shot still have shingles rash

About two weeks after the 1st shot I noticed my facial skin was very itchy. This was a constant thing. Two days after I had the shot shot my face swoll up and was very itchy. I was waking up in the middle of the night several times a night because of the itches and I was going my best no to scratch. i rubbed moisturizer in to my face and later started using some over the counter itching creams that would work for a few hours. I began to realize the itching was worse in places where I had five years ago had Bellafill infected into acne scars and deep wrinkles by a licensed cosmetic surgeon. I like the results and have no issue with the doctor or filler, but this stuff itched terribly. I see on the internet some complaints from others, but I wanted to report that I too have this. As of today, weeks later, it is not as bad, but as I write this I want to itch a place above my right cheek bone that was injected with Bellafill. I thought it was a problem with the Bellafill, I am convinced now it is a side effect of the vaccine. Guess this means it is working to adopt to odd things in my body.

Pfizer-BioNTech COVID-19 Vaccine EUA 2 Days following the vaccine both my Psoriasis (Plaque, Guttate, and Intertriginous) began to flare. It had been in remission for many months prior to this. I also had the usual chills and general malaise.

1 week after the shot my Lymph Node on the left side of my chin started to swell and become painful. AN off share rash also appeared on my left forearm.- The rash has mostly disappeared after 3-4 days. The Lymph Node swelling has reduced, but remains somewhat painful even after 5 days. (Mostly like a sore throat today)

shingles, started in right eye, then right side of face, up to top of head. intense pain, swollen eye lids, lot of bumps/rash Treating with Valacyclovir and Erythromycin for the eyes started 1 month after 2nd Pfizer vaccination.

Joint pains. 1) Left should pain with shooting pain down the arm to the wrist. Occurs infrequently 2) Wrist pain will occur when using the joint. 3) Knee joint pain in both knee - stiffness after sitting or from waking up with difficulty standing 4) Lumbar back pain - have had issues with this area prior

Arm pain at injection site, headache, fever, fatigue. Affects began about 15 hrs. after receiving the shot and lasted about 12 hrs. Experienced the same affects, minus the fever, after the first shot, but this time the affects were more severe then the first time. Did not require or seek medical or doctor assistance, simply stayed hydrated and rested.

Arm pain at injection site, fever, fatigue. Affects began about 18 hrs. after receiving the shot and latest about 12 hrs.

Fever of 101.5, which persisted for 3 days. Headache for two days (04/09 PM thru 04/11) not elevated by 2X Tylenol dose. Pain and swelling at the vaccine sight. Left upper arm swelling and hot (102.4 with digital thermometer. Marked swelling in underarm (arm pit) grossly visible (photos taken) and arm it temp over 102 to 2 days and over 101 for 4 more days (total of 6 days) with notable swelling and elevated temperature in the area. Appears normal at day 8 DPI. This is the most adverse reaction I have ever had to any vaccine in my memory. As I have been working in Asia, I have had several vaccines in my life and in recent years. Never a reaction like this.

Skin on the side of my forearm is hypersensitive and paimful to the touch. It is the same arm as I received teh injection. It first presented after my first dose (03/19/2021 and started to subside. After the second dose the pain and sensitivity increased. It has bee 1 week since second dose.

Starting about 2 weeks after vaccine administration in left deltoid, patient started having a blotchy rash on left inner forearm. It looks like a giant bruise or almost like bleeding under the skin. Dark round circles. No pain, swelling, itchiness, or fluid. No pain on applying pressure to it. Was worried it was a blood clot but we think it is associated with receiving the vaccine as it is only in the left forearm. Patient states that it is "clearing up".

12 days after injection the left arm (injection area) is increasing in muscular pain and losing mobility.

Shingles started on march 9th after second shot of Vaccine. took antiviral medicine for 7 days, still in pain taking Gabapentin for pain

Slight petechiae to face and neck and light headed. BP 118/76. Per wife pt experiences rash like symptoms with each new medication. After observation pt discharged home with wife.

I DEVELOPED RED BLOTCHY SORES / ITCH/ 2 ON LEFT LEG/1 ON RIGHT LEG/ AFTER MORE THAN A WEEK WITH NO RELIEF, I VISITED URGENT CARE (03/29/21) / DR DIAGNOSED WITH SHINGLES. I ALSO EXPERIENCED UNEXPLAINED BACK PAIN WHICH WAS EXPLAINED TO POSSIBLY BE SHINGLES ALSO. TREATED WIT VALACYCLOVIR HCL 1 GM TABLETS FOR 10 DAYS. SORES ARE NOW DRY BUT STILL ITCHY. NOTE: I WAS VACCINATED AGAINST SHINGLES AT THE END OF 2020 ( 2 SHOT DOSE) I HAVE NOT SOUGHT FURTHER MEDICAL ATTENTION AS OF THIS DATE.

Henoch Schonlein Purpura/IgA Vasculitis, with purpuric rash, abdominal pain, diarrhea 1 week post vaccination IV solumedrol followed by 8 week prednisone taper, rapid improvement with steroids after colonoscopy

Patient reports developing itchy raised hives 4-5 days after receiving first dose of vaccination. Hives located on left arm, top of head and back. Improved spontaneously, now has slightly raised areas of skin where hives were located. No longer itchy.

Blistering, wet rashes on legs; Rash and blisters affecting feet; muscle pain has been going on for a while, but it got worse after the Covid-19 vaccine; Fever; Feeling unwell/Wasn't feeling good; Lost a lot of weight; Had to overuse inhaler; joint problems; Couldn't think; Affecting mental health; Blistering, wet rashes on legs; This is a spontaneous report received from a contactable consumer (patient). A 61-year-old-male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number was not reported), via an unspecified route of administration on 09Mar2021 (received at 61-year-old) as single dose for COVID-19 immunization. Medical history included arthritis, overactive immune system, unspecified mental health issues, and ongoing muscle pain. Concomitant medications were unspecified; the patient stated that he is on 4 vials of different medicine, or maybe 5. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number was not reported), on an unspecified date for COVID-19 immunization. The patient reported that he had the Covid-19 vaccine. He reported that he was given a handout sheet that he read after he had the second dose of the Covid-19 vaccine. It was highlighted in yellow that he shouldn't have taken the Covid-19 vaccine with an overactive immune system. He further reported that the second dose of the Covid-19 vaccine is affecting his mental health. His mental health started being affected about 7-8 days after receiving the second dose of the Covid-19 vaccine. He stated that he is getting blistering, wet rashes on his legs again. He would like to see what he can do about this, but he will have to do it by mail. He reported that he has to get pictures taken of himself. He has an appointment tomorrow where he got the Covid-19 vaccine. He stated that he also has to go back to the dermatologist that is taking care of his immune system. He reported that he has lost a lot of weight. He reported that his weight is 147 pounds or maybe 141 pounds. He has lost a lot of weight since receiving the Covid-19 vaccine. He was given an emergency authorization release after he got the second dose of the Covid-19 vaccine. He noticed that he wasn't feeling good right away after getting the Covid-19 vaccine. When his legs started getting a rash and then blisters, his medical provider took pictures. The rash and blisters are affecting his feet too. The rash on his legs appears about 7-8 days after the second dose of the Covid-19 vaccine on 09Mar2021. He reported that what is on his legs started as rash and then turned into blisters. The blisters popped and it's like poison comes out. The fluid from the blisters smells, and that the fluid is ruining his clothes and is going to ruin shoes. The rash got worse the other day, with blisters forming. The blisters have now popped and there's going to be scars. The patient reported that he now has open wounds on his legs that bleed from the popped blisters. He also reported that it felt like all of his arthritis and muscles were affected. He took something for muscle spasms and arthritis, a muscle relaxant, for his back. Everything hit about the same time, 7-8 days after receiving the Covid-19 vaccine on 09Mar2021. The muscle pain has been going on for a while, but it got worse after the Covid-19 vaccine. The patient also experienced joint problems, fever, feeling unwell on an unspecified date, had to overuse inhaler, couldn't think on an unspecified date. Outcome of affecting his mental health was recovering. Outcome of blistering, wet rashes on legs, muscle pain has been going on for a while, but it got worse after the Covid-19 vaccine was not recovered. Outcome of other events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

A flare of psoriasis (plaque, guttate, and intertriginous) and psoriatic arthritis; A flare of psoriasis (plaque, guttate, and intertriginous) and psoriatic arthritis; This is a spontaneous report from a non-contactable consumer (patient). A 61-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot Number: ER8734) via an unspecified route of administration in the right arm on 09Apr2021 at 12:00 (at the age of 61-years-old) as a single dose for COVID-19 immunization. Medial history included HTN (hypertension), high cholesterol, CAD (coronary artery disease), depression, allergic rhinitis, all from unspecified dates and unspecified if ongoing and ongoing psoriasis and psoriatic arthritis from unspecified dates. It was unknown whether the patient was diagnosed with COVID-19 prior to vaccination. The patient had no known allergies. Concomitant medications included apremilast (OTEZLA) taken for psoriasis and psoriatic arthritis from an unspecified date and unspecified if ongoing. It was reported that no other vaccine was received in four weeks prior to the COVID-19 vaccine and it was also reported that another vaccine was reported in two weeks prior to the COVID-19 vaccine. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot Number: ER8730) via an unspecified route of administration in the right arm on 19Mar2021 at 09:00 (at the age of 61-years-old) as a single dose for COVID-19 immunization. On 11Apr2021 the patient experienced a flare of psoriasis (plaque, guttate, and intertriginous) and psoriatic arthritis. The clinical course was reported as follows: "I take Otezla for Psoriasis and Psoriatic Arthritis. I have been well controlled for over a year. On the 3rd day following the vaccine I developed a flare of psoriasis (plaque, guttate, and intertriginous) and psoriatic arthritis." Treatment was not received for the events. The clinical outcomes of the events a flare of psoriasis (plaque, guttate, and intertriginous) and psoriatic arthritis were both recovering/resolving. Since the vaccination, the patient had not been tested for COVID-19. No follow up attempts are possible. No further information is expected.

The day after my second shot toes on both of my feet turned purple and I developed blisters. It largely went away within about 24 hours. One week after the shot, these symptoms have returned, and they are worse. I have blisters on both feet, and I feel like I have some nerve sensitivity.

Post Vaccine patient complained of having an itchy back. Pt transferred to med obs. Pt back appears red with no noticeable rashes/ bumps or hives . Pt reports his skin is no longer itching, and skin remains free from rash. Vitals obtained and monitored. Onsite physician sent patient home with PO Benadryl. Pt instructed by physician to take Benadryl once home if itching returns and to seek medical attention if symptoms were worst. Pt released at 1200 1140 BP 160/93 HR 100 RR 20 SPO2 96 1150 BP 143/90 HR 102 RR 20 SPO2 97 1155 BP 132/95 HR 102 RR 20 SPO2 97

Sunburn-like pain on his back; Sunburn-like pain on his back; Rash on his back / patch-like rash on his back; Itching on his back; Left arm pain; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 61-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included TOZINAMERAN (COVID-19 VACCINE PFIZER) for prophylaxis. Concomitant products included TOZINAMERAN (COVID-19 VACCINE PFIZER). On 3rd March 2021, the patient received the 1st dose of Shingrix. On 8th April 2021, the patient received the 2nd dose of COVID-19 VACCINE PFIZER. On 4th March 2021, 1 days after receiving Shingrix, the patient experienced pain in arm. On 19th April 2021, the patient experienced pain burning, back pain, patchy rash and localised pruritus. The patient was treated with lidocaine, dermatologicals nos (Lotion) and ambiguous medication nos (Cortisone (Nos)). On 8th March 2021, the outcome of the pain in arm was recovered/resolved. On an unknown date, the outcome of the pain burning, back pain, patchy rash and localised pruritus were not recovered/not resolved. It was unknown if the reporter considered the pain in arm, pain burning, back pain, patchy rash and localised pruritus to be related to Shingrix. Additional details were provided as follows: The patient reported for himself. The patient was vaccinated with Shingrix in his left arm. The patient had left arm pain next day after vaccination with Shingrix. On 18th March 2021, the patient was vaccinated with 1st dose of Pfizer Covid vaccine in his right arm. On 8th April 2021, the patient was vaccinated with 2nd dose of Pfizer Covid vaccine in his right arm. On 19th April 2021, 1 days after receiving Pfizer Covid vaccine and 47 days after Shingrix vaccine, the patient experienced Sunburn-like pain, itching and rash on his back. On 26th April 2021, the patient experienced patch-like rash on his back. The patient used over the counter lotions, cortisone, and Lidocaine P. The patient did not receive his second Shingrix vaccination. The patient did not share any information except his name and date of birth. The lot number and expiration date of Shingrix vaccination was not known. The reporter did not share if he received his vaccine at a pharmacy or his Heath Care Professional's office. The reporter did not consent to follow up. It was unknown if the reporter considered the back pain, pain burning, patchy rash and localized pruritus to be related to Pfizer Covid vaccine.

On 4/14/2021 patient developed pain in left shoulder blade with numbness in the front of chest and under left arm and biceps, and broke out rash on Sunday 4/18/2021 and on Monday, 4/19/2021 he developed blisters and he went to Urgent care and was diagnosed with Shingles. He received a prescription for the rash, (Valacyclovir TID x 7 days), but he used Calamine lotion and applied that to the rash which improved. . Went to see his health care provider a week later on 4/26/2021. and received pain medication Tramadol, which was very helpful with reducing the pain. He was advised to get the 2nd dose of Pfizer vaccine on 4/29/2021. As of this date no complaints. He was encouraged to use V-Safe and he is being followed by them at this time.

Per received vaccine on 4/30/21 patient called pharmacy 2 days later on 5/2/21 after receiving shot, stated he has a golf ball size red itchy skin on left palm and also rash inner side of forearm. Patient only feeling itchiness, but otherwise stated feeling OK. We sent a fax to PCP on 5/3/21 @10am and are waiting for a response. Patient will also contact PCP for next steps.

Vaccine injected into right arm too high/too forceful. High level of pain at time of injection in shoulder. Experienced patient in receiving injections, Dr. did not properly identify location markers. Shoulder pain (not arm) still exists. Dr (who administered vaccine) needs to measure twice before injecting.

front of both thighs looked sunburnt, were beet red; front of both thighs looked sunburnt, were beet red; This is a spontaneous report from a contactable consumer (Patient). A 61-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6200, expiry date:30Jun2021) via intramuscular at left arm on 24Feb2021 as single dose for COVID -19 Immunization. Patient medical history included Floxin, Penicillin, Prednisone, lacerated cornea and Bee Stings and allergic to chigger bites. He did have to use Prednisone for a lacerated cornea last year and he had to put drops in his eye, but he doesn't have any leftover or anything to provide for the report. Concomitant medication was not reported. No prior vaccination received within 4weeks. On 24Feb2021 patient experienced front of both thighs looked sunburnt, were beet red and thighs looked totally sunburn. He stated that the sunburn didn't hurt. He had no pain. No treatment was given to the event. Outcome of event was recovered on 25Jan2021. Caller declined to take down the report reference number. No further details were provided or obtained.

after pt received 1st dose of covid vaccine, pt started having increased shortness of breath. he went to see his PCP and his PCP prescribed inhaler for him since his PCP thought it was due to his asthma exacerbation. but the inhaler didn't help. Shortness of breath worsened and pt started to have yellow/white phlegm. he came to ED for further evaluation. he was very hypoxic and tachycardic. per chart, he was noted to be mottled from his lower extremity up to his abdomen. BNP and troponin elevated.

1. Had very itchy rash all over my body. Took Benadryl and itchy level went down. After 4 days, rash went away. 2. Continue to had burning smell since April 20, 2021 (11 days after 2nd shot) to present, especially in the morning, the smell is really intense.

Swelling, cramping, redness, pain, and warmth in left leg. He went to Urgent Care. The ultra sound lady said she saw a small clot. The PA he saw reported the radiologist did not diagnose a clot. The PA cautioned from prescribing any blood thinners for fear of interacting with DM medications (metformin and lisinopril).

Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Chest Tightness / Heaviness / Pain-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Hyperventilation-Medium, Additional Details: patient's husband says pt was admitted to hospital with burning in chest, heart, throat swelling, anxiety and trouble breathing.

Within the first hour my left arm started swelling at the site of the injection. The swelling was well past the band-aid to the point of taking off the band-aid to relieve pressure. Four hours after the vaccination I had begun to have pain in my left shoulder when trying to use my left arm/hand. This pain in my arm is still very high after 5 weeks. The pain is actually worse as I cannot play golf with extra pain in my back swing.

Itchy rash all over body. The Doctor said that it is psoriasis, which I didn?t have prior to the vaccine.

Client received 2nd COVID vaccine of Pfizer (Lot# EW0185 expiration 05/23/2021). RN noticed Client turn red and become flushed to the skin. RN provided supplemental nutrition and fluids. Client accepted. At 1740 RN and PHN responded to this event. At 1741, vital signs are blood pressure 150/90, heart rate 100, oxygen saturation 96%. Client reports anxiety, no dizziness, no headache, no blurred vision, no chest pain. Client reports history of hypertension, takes blood pressure medication every morning (today's morning dose was administered via self at home), takes over the counter aspirin as needed, and no known allergies. At 1745, vital signs are blood pressure 144/88, heart rate 101, oxygen saturation 95%. Client reports no complaints with the 1st dose. Per Client had a very stressful day. The flush reaction of the face happened within 2 minutes of administration. RN educated Client in regards to ED precautions and common adverse effects of COVID vaccine. At 1750, vital signs are blood pressure 140/88, heart rate 90, oxygen saturation 98. Client reports symptoms have resolved and skin tone returned to appropriate coloration to ethnicity. At 1800, vita signs are blood pressure 130/88, heart rate 92, oxygen saturation 97%. At 1801, Client stood up with no complaints. At 1802, Client walked out of facility with a steady gait.

severe psoriasis; Large and small red welts and bumps; Large and small red welts and bumps; It is incredibly itchy; This is a spontaneous report received from a contactable consumer (patient). This 61-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 left arm on 24Mar2021 at 18:15 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Medical history included ulcerative colitis, and penicillin early generation allergy, both from unknown dates and unknown if ongoing. Prior to vaccination the patient was not diagnosed with COVID-19. The patient had no allergies to foods. Concomitant medications included prednisone 5 mg from an unknown date for an unknown indication. Prior to vaccination the patient received azathioprine from an unknown date for an unknown indication and experienced drug allergy; infliximab (REMICADE) from an unknown date for an unknown indication and experienced psoriasis; adalimumab (HUMIRA) from an unknown date for an unknown indication and experienced psoriasis; and received the first dose of BNT162B2 (lot number unknown) on 24Feb2021 at 18:15 (at the age of 60-years-old) for COVID-19 immunisation. The patient had not received any other vaccines in the four weeks prior to the COVID vaccine. The patient reported that on 04Apr2021 he developed severe psoriasis within three weeks of the vaccine; further stating he developed similar reactions to infliximab and adalimumab and generally had received methotrexate to control the reaction. He reported large and small red welts and bumps on his arms, torso and hands, as well as to a lesser extent his face, scalp, buttocks, legs and feet. He reported it was incredibly itchy, similar to poison ivy or bad psoriasis. He reported not having these symptoms prior to the vaccine, that there had been no intervening medicines, and that he had no food allergies. The clinical outcomes of severe psoriasis, large and small red welts and bumps, and it was incredibly itchy were not recovered. It was also reported that since vaccination the patient had not been tested for COVID-19. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Tongue swelling through the night. Did not seek treatment. Went away next morning. Rash area on arms and legs.

a little rash on my arm and it won't stop itching; a little rash on my arm and it won't stop itching; This is a spontaneous report from a contactable consumer reporting for himself. A 61-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration on 10Mar2021 (Batch/Lot Number: EW6208) as a single dose (at the age of 61 years old), and dose 2 via an unspecified route of administration on 31Mar2021 (Batch/Lot Number: ERB731) as a single dose (at the age of 61 years old) for COVID-19 immunisation. Relevant medical history was not provided. Concomitant medication included a lot of unspecified medication. On an unspecified date, the patient experienced a little rash on my arm and it won't stop itching. Therapeutic measures were taken as a result of a little rash on my arm and it won't stop itching included diphenhydramine (BENADRYL). The patient reported that he took diphenhydramine to stop it but it's still right there. The outcome of the event a little rash on my arm and it won't stop itching was not recovered. Information on Lot/Batch number was available. Additional information has been requested.

RASH ON BIL UPPER EXTREMITIES, SOB, CHEST TIGHTNESS, NUMBNESS ONLIPS, 10 MG ZYRTEC GIVEN PO, BENADRYL CREAM APPLIED TOPICALLY TO RASH ON UPPER EXTREMITIES AT 1:10 PM. EXTENDED MONITORING FOR 1 HR WITHI SYMPTOMS LESSENING. VITALS STABLEAT 137/87 BP, HR 76, RR 18, 97% OXYGEN ON ROOM AIR AT 1:50 PM. PATIENT ADVISED TO SEEK ADDITIONAL MEDICAL EVALUATION.

This is a spontaneous report received from a non-contactable consumer. A 61-year-old male patient received first dose of BNT162B2 (COMIRNATY, Solution for Injection, Batch/Lot Number: unknown, Expiration Date: Unknown), via unspecified route of administration on right arm on 07 Mar 2021 for COVID-19 immunization. The patient medical history was not reported. The patient was allergic to strawberries, latex. The patient's concomitant medications were not reported. Patient had no other vaccine in four weeks. The patient had no COVID-19 prior vaccination nor tested post vaccination. On 08 Mar 2021 the patient experienced breaking out in big hives, right shoulder, under right arm, left shoulder. Some hives round, some square, some long and thin after 30 hours of vaccination. The outcome of the event was not recovered. Treatment for the event taken by the patient included hydrocortisone cream as self application. No follow-up attempts are possible. Information about lot/batch number cannot been obtained. No further information is expected.

swollen and red leg; swollen and red leg; blood clot in right leg; Pain in right leg; her husband cannot walk, he is limping; her husband cannot walk, he is limping; This is a spontaneous report from contactable consumers (patient and wife). A 61-year-old male patient received bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE), dose 2 at vaccination age of 61-year-old via an unspecified route of administration on 21Apr2021 13:00 (Lot Number: ER3732; Expiration Date: 30Nov2022) as 2nd dose, single for covid-19 immunisation. Medical history included ongoing high cholesterol and ongoing prostate [having to go to the bathroom frequently] (prostatic disorder). The patient received the first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE) at vaccination age of 61-year-old on 26Mar2021 3:45 pm for covid-19 immunisation. Concomitant medications included (LIPITOR) ongoing since unspecified date (reported as 3 or 4 years ago) for blood cholesterol increased, and tamsulosin on an unspecified therapy dates (reported as he has been taking it for years now) for prostate/having to go to the bathroom frequently (prostatic disorder). The patient did not receive other vaccine in the last four weeks prior to vaccination. The patient received the vaccine from a pharmacy. The patient reported that one week after getting the second vaccine, he had pain in his right leg (28Apr2021). He stated that he did know what was going on, but he continued to work. He added that last Monday (10May2021) it got worse, so he contacted his primary care doctor and he went today (12May2021) because his leg was swollen, red and he had pain. His doctor sent him to the ER (emergency room). The patient mentioned that the ER did a CAT scan on 12May2021 and found that he had a blood clot in his right leg (reported as 10May2021). The patient's wife comes on the line and stated the reason her husband called to report was because it could be from the vaccine, but they are not sure. The wife added that her husband went to the pharmacy to pick up the blood thinner and they told him to report this. She also stated that all the side effects could happen, but he did know the side effects and he just wanted to report because the pharmacy told him to report. She mentioned that her husband started complaining his leg hurt because he has to do yard work. She states that it got worse and worse and she saw his leg get swollen and she was like you need to go to the doctor. The wife mentioned that the leg is more swollen and painful, but is the same, her husband cannot walk, he is limping on an unspecified date in 2021. She stated that her husband has just started taking medication, yesterday and today. The outcome of the event thrombosis leg was not recovered while the outcome of the other events was unknown.

sore in arm shot the next day, slight fever the next day, fatigue the next day, frequent urination the night of vaccination

Pain at inject site; Myalgia at the injection site; This is a spontaneous report from a contactable physician (patient). This 61-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EK9231), via an unspecified route of administration in left arm on 09Jan2021 at 09:30AM as a 1ST DOSE, SINGLE for COVID-19 immunization. The patient had no medical history and family history. The patient's concomitant medications were not reported. The patient did not receive other vaccinations with 4 weeks of COVID-19 vaccine. The patient did not undergo any lab test. On 09Jan2021, the patient experienced injection site pain and myalgia for three days. The patient did not require a visit to physician or ER (emergency room). The outcome of the event was resolved on 12Jan2021. The reporter assessed the events injection site pain and myalgia as related. Follow-up attempts are completed. No further information is expected.

very sore arm at the injection site; very sore arm at the injection site; This is a spontaneous report from a non-contactable consumer(patient). This 61-year-old male patient reported that he received first dose of BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: Unknown, and Expiration date: Unknown), via an unspecified route of administration on 17Jan2021 as 1st dose, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that the patient (frontline worker), received his first dose of the Pfizer COVID vaccine on 17Jan2021. On an unspecified date the patient had a very sore arm at the injection site which he was never had with a vaccine before, and the patient had no side effects except these. The outcome of the events was unknown. No follow up attempts are possible. Information about lot/batch cannot be obtained. No further information is expected.

Significant face and neck swelling; Significant face and neck swelling; redness 20 minutes after injection; This is a spontaneous report received from a contactable consumer, the patient. A 61-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: 59267-1000-01), via an unspecified route administration in the left arm on 12Mar2021 at 17:15 (at the age of 61-years-old), as a single dose for COVID-19 immunisation. Medical history included mild hypertension. Concomitant medications were not reported. The patient was allergic to bee stings. 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. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced face swelling, neck swelling and redness on 12Mar2021 at 17:35. It was reported that events were not anaphylactic and the condition peaked within 1 hour, returned to normal within 4 hours. The reported events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken for the reported events. The clinical outcome of the face swelling, neck swelling and redness was recovered on 12Mar2021. No follow-up attempts are needed. No further information is expected.

Nothing major; slight redness at injection site and a sore arm for 24 hours; Sore arm; This is a spontaneous report from a contactable consumer (patient). A 61-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6195), via an unspecified route of administration on 04Mar2021 12:30 as unknown, single for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient has not had other vaccine in four weeks. The patient has no history of COVID prior vaccination. The patient was not COVID tested post vaccination. The patient experienced nothing major; slight redness at injection site and a sore arm for 24 hours on an unspecified date. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.

Sharp pain at the injection site; This is spontaneous report from a contactable consumer. A 61-year-old male consumer (patient) reported for himself that he received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot number: EW0172) via unspecified route of administration in left arm on 06May2021 13:30 (age at vaccination was 61 years) as 2nd dose single dose for COVID-19 immunization. The patient's medical history included blood pressure, cholesterol and allergic to dogs, cats, horses, ragweed from unspecified dates. The patient's concomitant medication includes hydrochlorothiazide 25mg, amlodipine besilate 10mg, lisinopril 40mg for blood pressure, rosuvastatin 10mg for cholesterol on unspecified dates. Historical vaccine included BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot number: EW0150) dose 1 via unspecified route of administration in left arm on 14Apr2021 13:30 as 1 dose single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On unspecified date, it was reported that, the patient had the first dose of the Pfizer Covid Vaccine on 14Apr2021 and had the second dose on 06May2021, more than 21 days later. After the first dose he had a sore arm, and after the second dose he still has sharp pain at the injection site a month later. Patient comes on the line. He had the first shot and had no reaction whatsoever, not even any pain in his arm until a week and a half or 2 weeks later and it was minor pain. After the second shot he had no allergic reaction and no problems. He got the second dose on 06May2021. Within the last 2 weeks or so every time he moves his arm a certain way, he has a sharp pain in the injection site. Normally there is some soreness that goes away, he is surprised to still have this. He didn't call his doctor because it is too new and they won't know. Second dose sharp pain in the injection site, After the second shot he has the same thing after a month now. Right now, he can extend his arm out. It probably started right after he got the vaccine, but the sharp pain now is what bugs him. He can stand here now and extend his arm out and bend his elbow up and feel a little bit of pain, but nothing major. Every once in a while, it will turn into a sharp pain and he will move a certain way and have sharp pain. It has gotten worse over time. He thought it was something that would fade away over time. He can stand and move his arm every which direction, but he will be doing some work around the house and suddenly have a sharp pain. He can't duplicate the pain right now. The question he is posing is if this is something that is being reported and if it is a concern or not a concern. He realizes it is all new, and that is why he is posing the question. He asks if this is expected or out of the ordinary. The patient's lab test include blood work two weeks after the shot, but it was nothing for his arm. The clinical outcome of the event was reported as not recovered. No follow-up attempts are possible.

I woke up with terrible lower back pain and shooting pains in legs. I had difficulty and extreme pain standing and walking. Doctor's examination revealed inflammation of lower back around spine. X-rays revealed arthritis in lower back and minor disc slippage/bulging, as expected for age. Since no back injury or strain, Doctor diagnosed it as probable immune system going into over-drive due to vaccine and attacking lower back arthritis resulting in inflammation and pinched nerves. Treatment was muscle relaxers for a few days and Physical Therapy for lower back. Cleared sufficiently in 2 weeks to get second dose of vaccine on time, with no problem.

Herpes Zoster - lower back and L inner thigh, duration 3 weeks. Photos taken by patient, reviewed by physican.

Twelve days after receiving the second Pfizer COVID-19 shot I had come down with a case of oral shingles. All of this was on the left side of my face: Swelling of lower lip, swelling of tongue, hardness to tongue, ulcers in mouth and tongue, numbness to lips, tongue, and gums, sensitivity to hot and cold on teeth, redness on face, some small outbreaks of oozing around chin, sensitivity of head, face, neck and shoulders all on that left side.

hives on my stomach, side, arms, thighs; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old adult female patient received her unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: unknown) via an unspecified route of administration in the left arm on 11Mar2021 at 11:15 (at the age of 61-years-old), as a single dose for COVID-19 immunisation. The patients medical history was not reported. The patient had allergies to various antibiotics, shellfish, bees, honey & other medicine additives. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 16Mar2021, the patient experienced hives 4-5 days later, on stomach, side, arms & thighs. The patient received benadryl & prednisone for the adverse events. The clinical outcome of the events hives on stomach, side, arms & thighs were not recovered at the time of this report. Information about lot/batch number cannot be obtained. No further information is expected.

Received the first Pfizer COVID vaccine (ew0161) injected at 4:30PM on 29 April 2021 at the Pharmacy. He became weaker, more tired and sleep afterwards, He developed decreased oral intake. He was unable to recall his name, so family brought him to the ER. In the ER he was noted with significant anemia Hgb 6.5 and thrombocytopenia with platelet of 6. There is question of hemolysis with reticulocyte 8, LDH 1757, total bill 3.8. There is elevated D-dimer and renal function. Hematology consultation was placed for possible TTP versus COVID vaccine induced thrombocytopenia. PT was placed on plasmapheresis and found to have ADAMST13 def. PT received S/p plasmapheresis 11 times PT was placed on plasmapheresis and found to have ADAMST13 def. PT received S/p plasmapheresis 11 times on 4, 5, 6, 8, 9, 10, 11, 12, 13, 17, 19 May 2021. Received Rituximab 375 mg/m2 = 731 mg IV weekly X 4 on 5, 13, 19, 26 May 2021. Completed high dose steroids 1000 mg x 3 days AMS and seizures 2/2 TTP related metabolic encephalopathy(i mproved), Small R parietal subdural hematoma­ likely related to TTP. No focal deficits. Treated for TTP with plasmaphoresis.initially alert but not oriented. Had an episode of seizure, intubated for airway protection Patient was hospitalized for 15 days 4-19 May 2021. He was in ICU for 1 week and 8 days in general ward. He was unconscious for the first week experienced 2 episodes of seizure. He has been comatos since he developed the first episode of seizure on 5/5/21. He developed another episode of seizure after the brain MRI on 5/5/21. PT discharged on 19/5/21 and continued blood works and Ritoximab therapy as out patient. Assessment: TTP, based on his clinical features including altered mental status, fe1er, hemolytic anemia and thrombocytopenia, renal insufficiency, and peripheral smear with 7-8 schistocytes per HPF (5/4/2021). Adam Ts 13 activity <3 Hemolytic anemia, severe thrombocytopenia 212 TTP with AdamTs13 deficiency In setting of hemolytic anemia, thrombocytopenia, AKI and AMS Hgb 6.5, Bili 3.8, LOH 1757, ARC 3.6 significant for hemolytic anemia on adm Peripheral smear showed anisocytosis, microspherocytosis and possible 1 schistocytes Platelet 6, multiple petechiae, no active bleeding, guaiac negative. Received 1U PRBC. Direct Coombs test -ve , Tbili elevated Plasmic score 6 Acute kidney injury 212 TTP vis Prerenal (Resolved) , Hyponatremia (resolved) FENA 0.5 Hematology followup: TTP (THROMBOTIC THROMBOCYTOPENIC PUPURA) 5/14/21 He developed a new ulcer in the mid of tongue. He coughs and sputum is clear. He feels better. Sip plasmapheresis and rituximab infusion yesterday. 5/13/21 He continues improling. Good appetite. He still coughs with blood streak, slightly pinkish sputum. 5/12121 His mental status is back to baseline. He is able to eat regular food and walk inside his room. Clo cough with blood streak, slightly pinkish sputum. 5/10/21 Fully alert and awake, but reported confusion and forgetful episodes. Eating better. Clo tightness in arms 5/9/21 More alert and awake. Started eating. Feeling tired. Clo mild pain at shoulders. Sip 1 unit PRBCs 5/8/2021 Mild improvement. Wife is at bedside. No acute overnight events. Still has intermittent confusion. Surgery re-placed left IJ Shiley for PEX 5/7/2021 He has intermittent confusion and irritation, mixed with short-term of AAO x 3. He pulled out his PEX line and has urinary incontinence. He is NPO and remains sleeping most of time. 5/6/2021 Sip extubated. He appears tired, but arousable, follows commands and carries normal communication with b/I symmetric strength with no motor deficits. Afebrile since last night. 5/5/2021 He developed 1 episode of seizure. Sip Ativan and 1 dose of propofol for intubation. He has been in comatose since then. Brain MRI was performed this afternoon. He developed another episode of seizure after the brain MRI. Sip 1 unit packed RBC 5/4/2021 and 1 unit packed RBC 5/5/2021. He de1.eloped mild bleeding from the bronchial suction and Foley catheter. He de1.eloped fe1.er temperature 101 during the first plasmapheresis. Temperature was 104 about 2 hours after the first plasmapheresis. He has had persistent high fe1.er since then. 5/4/2021 Lab showed WBC 7.1, Hb 6.5, pit 6, MCB 92.1, neut 68%, re!8%, PT 14, PTT 30. 5, D-dimer 2.19, fibrinogen 490, CMP normal except Ca 8.1, Glu 189, BUN 47, Cr 1.57, T bili 3.9, direc!0.9, and AST 56. LOH 1757, TSH 4.828, serum HIV and hepatitis panel negati1.e, COVID-19 Ag, SARS-CoV2 Rapid and Flu Ag negati1.e. 5/5/2021 WBC 21,500, hemoglobin 6.2, platelets 17,000, neutrophils 69%, PT 14.9, PTT 28.3, D-dimer 5.5, glucose of 296, BUN 63, creatinine 2.18, total bilirubin 2.5, albumin 3.6, LOH 891, AST 57, ALT 32, alkaline phosphatase 51. Laboratory results: WBC H 13.2 (MAY 14) H 11.6 (MAY 13) H 13.4 (MAY 12) H 16.8 (MAY 11) ? Hgb L 9.9 (MAY 14) L 11.3 (MAY 13) L 10.8 (MAY 12) L 10.4 (MAY 11) Hct L 30.2 (MAY 14) L 33.3 (MAY 13) L 31.5 (MAY 12) L 31.2 (MAY 11) Pit L 92 (MAY 14) L 58 (MAY 13) L 63 (MAY 12) L 74 (MAY 11) Risk Assessment: Denies Alcohol Use Substance Abuse Risk As sessment: Denies Substance Abuse Tobacco Risk Assessment: Denies Tobacco Use

Constant left deltoid pain and stiffness that moderately limits range of motion of left shoulder; Constant left deltoid pain and stiffness that moderately limits range of motion of left shoulder; Constant left deltoid pain and stiffness that moderately limits range of motion of left shoulder; pain with any and all movement of left arm, pain at rest; This is a spontaneous report from a contactable physician (patient). A 61-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot/Batch number: EL926L, Pfizer NTEC), via intramuscular route of administration in left arm on 01Feb2021 at 10:30 (at the age of 61-years-old) as 2nd dose, single for covid-19 immunization. The most recent COVID-19 vaccine was administered in the public health clinic/veteran's administration facility. The patient medical history was none. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Patient did not receive any other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient previously took naproxen for hypersensitivity and experienced periorbital oedema. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot/Batch number: EL2183, Pfizer NTEC), via intramuscular route of administration in left arm on 11Jan2021 at 14:00 as 1st dose, single for covid-19 immunization. On 02Feb2021 patient experienced constant left deltoid pain and stiffness that moderately limits range of motion of left shoulder, i.e., 40% reduction in range of motion, positive tenderness to palpation, pain with any and all movement of left arm, pain at rest, but no redness or swelling or bruising. Events resulted in disability or permanent damage. Treatment received for the events included NSAID and physical therapy. The clinical outcome for the events was not recovered. Information on Lot/Batch number was available. Additional information has been requested.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events and suspect drug BNT162B2 cannot be excluded The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

I received the Pfizer shot in my left arm. The arm was sore at the shot location for 3 days...On the fourth day around 1:30 in the morning I woke up in a cold sweat and I felt my heart racing and also uneven heart beat. My blood pressure was up to 150/100. Over the next 20 hours this condition subsided and finally went away completely after 20 hours or so.

Headache; Fever; Chills; injection site soreness; Rash on inside of right thigh. Rash on left side of waist on the back side.; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206), via an unspecified route of administration in left arm on 19Mar2021 at 10:30 (61-year-old at the time of vaccination) as a single dose for COVID-19 immunisation. Medical history included cardiac artery disease. The patient had allergy to shrimp. Concomitant medications included atenolol (MANUFACTURE UNKNOWN), PLAVIX and CRESTOR for unknown indications from unknown dates. Patient had not tested positive for COVID-19 since having the vaccine. 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 20Mar2021 at 01:00, the patient experienced headache, fever, chills, injection site soreness, rash on inside of right thigh and rash on left side of waist on the back side. The adverse 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 headache, fever, chills, injection site soreness, rash on inside of right thigh and rash on left side of waist on the back side were not recovered. No follow up attempts are needed. No further information is expected.

Mild soreness at injection site then tired and achy that night. Fine next morning. Traveled to Dr's appointment and went shopping. Upon returning home, as I carried items up 3 steps to porch, I felt my heart begin to race. Thought I was just winded in cool temp. Parked and walked to house, up flight of stairs, drank water and set down. Still my heart was racing. My Watch beeped that I might be in possible A-Fib. Daughter-in-law, an LPN, stopped to pickup our grandchild. Took my pulse, said it was rapid and irregular. Told me to take 4 baby aspirins and get to ER. EKG showed I was in A-Fib , Blood work, tests etc. Admitted to Hospital for 1 1/2 days. Given Diltiszen and shots for blood thinner, IV's. Sent home, Converted to Normal Rhythm in couple of days. Saw Dr. He switched me to Cardeilol and Xarelto. Scheduled Echo of my Heart. Results were clean and fine. Now in Lymes (PLDS) Flareup.

Extreme exhaustion; serious muscle pain; joint pain; Injection site swelling; Injection site redness; This is a spontaneous report from a contactable consumer. A 61-years-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: unknown) via an unspecified route of administration on 22Mar2021 (at the age of 61-years-old), as a single dose for COVID-19 immunisation. Medical history and concomitant medications were unknown. It was unknown if the patient was allergic to any medications, food, or other products. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not tested positive for COVID-19 since the vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: unknown) via an unspecified route of administration on 01Mar2021 (at the age of 61-years-old), as a single dose for COVID-19 immunisation. On 22Mar2021, the patient experienced extreme exhaustion, serious muscle and Joint pain, swelling and redness at the site of injection. It was unknown the patient received treatment for the reported events. The patient was tested for pain scale and the result was 6 on a scale of 1-10. 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 extreme exhaustion, serious muscle and joint pain, swelling and redness at the site of injection were recovered on an unknown date at the time of this report No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Peripheral Neuropathy symptoms; tinnitus/Ringing/buzzing/chirping/humming in both ears; difficulty concentrating; Extreme sensitivity to sound; Vertigo; Dizziness; Earache; Anxiety; Chest pains; Chest stress; Spasms in chest and back; Began to get blur in right eye; Bowel movements changed; Numbness on face: lips, checks, forehead; Muscles have shrunk throughout body; Joints popping; Neck ache; Throat tight; Face and smile have changed; Hair is thinner; Hair gotten gotten more grey since these issues; Feet burning; numbness and tingling sensation in both legs to feet and both arms to hands and extremities; Back aching; muscle weakness; Brain fog; Fatigue - constantly feel like laying down; Difficulty Sleeping through night/Unable to nap throughout day; feet aching in joints; This is a spontaneous report from a contactable consumer. A 61-years-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: EW0150) via an unspecified route of administration, administered in left arm on 30Mar2021 at 14:45 as single dose for COVID-19 immunization. The patient's medical history was not reported. The patient's concomitant medications included finasteride, ascorbic acid, ergocalciferol, folic acid, nicotinamide, panthenol, retinol, riboflavin, thiamine hydrochloride. The patient previously took augmentin s. On 03Apr2021 at 18:00, the patient experienced tinnitus/ringing/buzzing/chirping/humming in both ears, difficulty concentrating, extreme sensitivity to sound, vertigo, dizziness, earache, anxiety, chest pains, chest stress, spasms in chest and back, began to get blur in right eye, bowel movements changed, numbness on face: lips, checks, forehead, muscles have shrunk throughout body, joints popping, neck ache, fatigue - constantly feel like laying down, throat tight, face and smile have changed and hair is thinner. The outcome of the events was not resolved.

I received second shot on 17Apr2021 in left arm as first shot, today is 01Jul2021 and i am STILL HAVING SEVERE PAIN IN THE INJECTION ARM. I have responded to the messages I have received askin; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 62 years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EL3302, Expiration date: unknown), via an unspecified route of administration on 17Apr2021 (at the age of 61-year-old) as dose 2, single for covid-19 immunisation. Medical history included blood pressure abnormal. Concomitant medications included alprazolam (XANAX) taken for an unspecified indication, start and stop date were not reported, blood thinner (unspecified). The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EL3302, Expiration date: unknown), via an unspecified route of administration on 27Mar2021 12:00PM as dose 1, single for covid-19 immunisation. The patient had no allergies.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. On 20Apr2021 02:00, the patient experienced Pain in injection arm. Patient reported that he received second shot on 17apr2021 in left arm as first shot, today is 01jul2021 and he still have severe pain in the injection arm. The event resulted in doctor or other healthcare professional office/clinic visit. No treatment was taken as a result of event. The outcome of the event was not recovered.

Tinnitus (both ears) Major Skin Rashes (very itchy) -lower back, abdomen, Minor Skin Rashes (very itchy) - legs, back of neck.

Swelling and lots of pain in left arm at injection site, radiates up to left side of neck, left inner ear and left side of back of my head. panful headaches, pain in all my bones, vomiting, feverish , extremely tired and in bad mood. Chills and numbness on the left side of my face, including left side of my mouth and left eye making me almost lethargic and extreme bad mood. Light bother me a lot, feel nauseas. I am extremely weak when walking and have to make a great effort to walk since is extremely painful and I don't have much strength. Everything hurts, especially when I walk, I feel very weak.

Approximately two months after second dose of vaccination began to develop rash. Pruritic rash beginning in inguinal crease. Subsequently slowly developed moderately extensive pruritic vessicular rash on trunk. Similar rash slowly developed in a spotty distribution on extremities. After puruitic vessicular phase transformed to maculopapular appearance. Later stages formed on palms and soles of feet.

I was immediately confused about where I was at, when leaving the vaccination site. I immediately felt flush with red splotches on my face. I came home and took a nap just to sleep it off. I woke up with severe tinnitus, a headache, and brain fog. Both the tinnitus and headaches have only gotten worse. The flush feeling, (suspecting higher blood pressure than usual), comes and goes with more frequency as time goes by. The ?brain fog? has been more like brain damage. At first, I just couldn?t think. My ability to think has slowly improved, but it is no where near the same as my abilities prior to the vaccine. My memory has been impaired, both long term and short term. My hand/eye coordination has been impaired. Prior to the vaccine, I didn?t feel my age. After the vaccine I felt like I aged 25 years in a week. I need to figure out what is going on inside my head, and what can be done about it. The degeneration is a serious concern. Both in the severity of the adverse reactions, and in the permanence of the damage. This will be devastating if I?m entering early stages of dementia, decades before the course of natural causes of aging.

Patient had a rash on LEs & abdomen. He described it as painful & itchy. Benadryl & Hydrocortisone cream were administered. He f/u with his PCP.

tired; has no energy; can't think straight; dizziness; he has developed two spots on his right leg where the skin has fell off; two spots on his right leg that the skin fell off and swelling really bad; two spots on his right leg that the skin fell off and swelling really bad; throbbing; bad headache; feels hot and cold; This is a spontaneous report from a contactable consumer (patient). A 61-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 13Jul2021 (at age of 61 years old), (Batch/Lot Number: unknown) as dose 2, single for COVID-19 immunisation. Medical history included two heart attacks, three stent implants, and his lung had separated, also he had tube in his chest. He had to have six bypass open heart surgeries. His first heart attack was at age 55. Patient was taking unspecified concomitant medications. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number unknown, via an unspecified route of administration on 15Jun2021, (at the age of 61 years old), in left arm as single dose for COVID-19 immunization. The patient experienced dizziness and he has developed two spots on his right leg where the skin has fell off and are throbbing and swelling really bad for no reason, had bad headaches and feels hot and cold on 16Jul2021 (Friday). The patient stated he can't think straight right now and also stated he is tired, has headaches, and has no energy. If he gets up and walks around he gets dizzy. The headaches are constant. The patient stated he was calling because his son wants to take him to the ER. The outcome of the events was not recovered.

Hives over much of both the arms and legs as well as on the waist.; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158), via an unspecified route of administration in the left arm on 15Apr2021 at 10:00 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Medical history included high cholesterol. Concomitant medication included simvastatin (SIMVASTATIN) taken for high cholesterol from an unspecified date. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534), via an unspecified route of administration in the left arm on 24Mar2021 at 10:00 (at the age of 61-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-19 vaccination. On 17Apr2021 at 22:00, approximately two and a half days (60 hours) after the second shot, the patient experienced hives over much of both his arms and legs as well as his waist. The patient reported that these continued until the patient took medication to treat the hives. The event resulted in a doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of hives and included treatment with a 6-day prescription of methylprednisolone 4mg. The clinical outcome of the event hives was resolving at the time of this report. No follow-up attempts are needed. No further information is expected.

My upper arm at the area of vaccine site has been sore, throbbing aching with mild pain. Its bearable but not normal and comfortable. I had a scan of my upper are near the shot and they say that my veins look clear. But it don't feel its my vein. It feels like my nerve muscle tissue has been irritated. Something don't feel right

Fever; Chills; Aches; Injection site pain; Headache; Feeling unwell; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via an unspecified route of administration in the left arm on 05Apr2021 at 12:45 (at the age of 61-year-old) as a single dose for COVID-19 immunisation. Medical history included blood pressure high and penicillin allergy. Concomitant medications included rosuvastatin (MANUFACTURER UNKNOWN), hydrochlorothiazide (MANUFACTURER UNKNOWN) and Amlodipine-Benazepril (MANUFACTURER UNKNOWN) on an unknown date for an unknown indication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via an unspecified route of administration in the left arm on 15Mar2021 at 14:00 (at the age of 61-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 06Apr2021 at 01:00, the patient experienced fever, chills, aches, injection site pain, headache and feeling unwell. 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 event. The clinical outcome of the events fever, chills, aches, injection site pain, headache and feeling unwell was not recovered. No follow-up attempts are needed. No further information is expected.

felt a little sick; I got my temperature about 100.2/Fever that I have is 7 days after the vaccine; Had mild body ache; Chills; Usual soreness at the site of injection; Cough; mild sore throat; This is a spontaneous report from a contactable Physician (patient). A 62-year-old male patient received NT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: EL01-40), via an unspecified route of administration on 20Dec2020 09:30 at single dose for COVID-19 immunization. Anatomical Location provided as Left deltoid. Medical history provided as none. Concomitant medication included hydrochlorothiazide, levothyroxine sodium (SYNTHROID). Physician stated, he got his Pfizer vaccine on last Sunday on 20Dec2020 around 9:30 there was usual soreness at the site of injection on 20Dec2020, which was there but no problem. But Monday (21Dec2020) after his vaccine that was Sunday he had and Monday night on 21Dec2020 he had chills he thought these were all just the reaction to the vaccine. Next day on 22Dec2020 he went into work he had mild body ache at work, at about 3:30 he felt a little sick and he got his temperature about 100.2, get home rested, next day on 23Dec2020 he worked from home, did not go so for next four days (from 24Dec2020 to 27Dec2020) he rested at home but his chills and body ache are not going away. They were there, they come and go, he took Tylenol, it went he have mild sore throat, cough on Dec2020. Today on 27Dec2020, the patient just took the temperature 100.7. For Causality assessment: Physician stated, "he didn't know, he was just trying to find out to get to bottom of it. Is it really COVID infection or is it due to side effects as from what he read the reaction shouldn't really last long. It may last probably 3-4 days but this has gone beyond that so he was little concerned and the fever that he had was 7 days after the vaccine." The patient still had chills and body ache which he means they were not going away and now mild fever. When probed for the outcome of, Physician stated, "They are persistent you know some day he had one day which was good but after that in the afternoon in the evening he felt the same thing. Fortunately, he was off for four days it didn't really have much problem, physically it was persistent has not gone away." Therapeutic measures were taken as a result of chills, had mild body ache, felt a little sick, cough, fever, mild sore throat. The outcome of events chills, mild body ache was not recovered. The outcome of the other events was unknown.

Patient stated his arm from his elbow to his shoulder was warm for 1 hour. He also stated he was achy and he had joint aches more then usual.

Patient c/o Itchy rash over his abdomen, shortness of breath, itching inside his throat and feeling as if his throat was mildly closing. Patient received Benadryl 25mg IM, Solu-Medrol 125mg IV and Pepcid 20mg PO. Patient was sent out to ER for further evaluation. Patient returned from ER at 2349 with no new orders. ,No any acute distress reported.

Felt pinched when the vaccine was administered; soreness at the muscle site; little muscle soreness from the vaccine; Postnasal drip in throat; Feeling warm then really hot; Feeling weak; Clammy; sweaty; As if he was going to pass out; almost like a vagal reaction if you got a needle or were scared; vagal reaction but delayed; Heart might have been beating fast; Experience is like the dizziness related in the signs of a severe allergic reaction; Experience is like the dizziness related in the signs of a severe allergic reaction; Anxiety; anxious; This is a spontaneous report from a contactable physician (patient). A 62-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number and Expiration Date were not reported), intramuscular in left deltoid, on 30Dec2020 10:30, at a single dose, for COVID-19 immunization. The patient's medical history included ongoing mild intraocular pressure. The patient's concomitant medication included unspecified eye drops for a mild intraocular pressure. The patient previously took tetanus vaccine and experienced vagal reaction and passed out (in his childhood). The patient's past COVID tests were always negative. On 30Dec2020, the patient received it at a facility where he is a physician on staff, and they started giving it that day. It was administered by a pharmacist who was very clean and professional, and everything was fine. The patient received the COVID-19 vaccine in the left deltoid and felt pinched when the vaccine was administered, and he felt fine. He did not have any immediate reaction. He sat down, then got up and was standing talking to some colleagues, and about 10 to 15 minutes later, they were talking and felt a little postnasal drip in throat. His colleagues said that is what they felt as well. About 10 minutes later, the patient was feeling warm then really hot to the point where he felt the need for cool air. He added feeling weak and clammy as if he was going to pass out. He started to feel weak and warm and almost like a vagal reaction if you got a needle or were scared. It was almost like he felt hot, sweaty, and weak and feeling like he needed to get to a cool place and sit down. The patient's heart might have been beating fast, but he did not check his pulse. The patient went outside where the temperature was in the thirties and cold. The patient broke out in sweat and felt weak. The patient sat down, and it was cold outside, and he felt better. It passed and he felt fine after that. The symptoms lasted 10-15 minutes top, and it was resolved after the peak. The patient had soreness at the muscle site which got better overnight; little muscle soreness from the vaccine. The patient then got better and felt no other symptoms. He looked up the side effects and talked to the pharmacist. He spoke with a pharmacist, who provided the information on the reported adverse reaction of the COVID-19 vaccines and the signs of a severe allergic reaction included in the PI. He is not an allergic type person. He is familiar with those reactions and never had any trouble. He wasn't quite sure if it was related but then said it is probably somewhat related. The patient explained that he doesn't have any of the reported adverse reactions in the PI; but his experience is like the dizziness related in the signs of a severe allergic reaction in the PI, and he did feel that his heartbeat was fast. He is fine now though. The patient asked if his event is related to the vaccine and what is the impact on getting the second dose when reacting to the first. The patient was thinking that this event is a vagal reaction but delayed. He also explained that he was speaking with his colleagues, right after receiving the COVID-19 vaccine, regarding postnasal drip reaction. The patient also wondered if anxiety related to this discussion could have triggered his symptoms. Originally, he thought it was just him. But after talking to colleagues, maybe he was just a little anxious. He did not feel anxious going in. He did not need any intervention. He did not take any diphenhydramine hydrochloride (BENADRYL) or anything. He sat and rested, and it passed. He has been fine since. He needs a second dose in 3 weeks. There is not a lot of information about the side effects. It was not like he got a rash. He did not have any swelling of the tongue or throat. He just wanted to find out about if he should get the second dose. He really wanted to get the second dose. He just wanted to know if this was common or a concern and should he take the second dose. There were a lot of people getting the vaccine and this was not anything that stopped anyone from getting it. He is just trying to make sure and see how likely it was that it was related to the vaccine and how does it affect him getting the second dose. The patient was recovering from "Felt pinched when the vaccine was administered; soreness at the muscle site; little muscle soreness from the vaccine". The outcome of "Postnasal drip in throat" and "Anxiety; anxious" was unknown. The patient recovered from the other events on 30Dec2020. Information about lot number and expiration date for the suspect product will be requested in follow-up attempts.

Rash to Left torso spreading to midline of abdomen and to left side of back. Observing for past 30 hours. Slightly itching and internal hot flashes occasionally

PT received COVID #2 vaccine at 0830 to the left deltoid. Several hours after the vaccine he had arm soreness at injection site, body aches, fatigue, malaise, dizziness and lightheadedness. The symptoms persist the following day at which time pt was evaluated in th employee health clinic. Vitals normal. Neurological exam normal.

Swelling in axilla on same side as vaccine. Vaccine given in deltoid. Swelling in axilla. Does not appear to be infectious; no redness, no temperature. No parasthesia to hand. Parasthesia to site only. Started the day after the vaccination, which was

Have a cut in my leg which is very unusual; Saw a big cut in my feet; I was bleeding from somewhere; It was quite a lot of blood drawing out of my body; This is a spontaneous report from a contactable consumer (patient). A 62-year-old male patient started to receive single dose of BNT162B2 (Solution for injection, batch/lot number and exp date not reported), via an unspecified route of administration on 23Dec2020 09:00 for COVID-19 immunization; and adalimumab (HUMIRA), via an unspecified route of administration from an unspecified date at unspecified dose (injection every other month) for arthritis. Medical history included arthritis, blood pressure (abnormal), and blood cholesterol (abnormal). Concomitant medication included rosuvastatin for blood cholesterol, olmesartan medoxomil, metoprolol succinate (TOPROL XL), and vitamins: ascorbic acid, ergocalciferol, nicotinamide, retinol, riboflavin, thiamine hydrochloride. Patient stated, "The reason I am calling, I have just a concern that something happened to me. I did not pay much attention but now I have read the news one doctor died after getting this COVID Vaccine (Further details were not available over the call) I have a small incident happened to me the day after I received my first dose of the COVID Vaccine. I just wanted to get some information. You know what happened the next day night, in the evening I was taking a shower and all of sudden I was bleeding from somewhere. Lot of blood was coming out while I was toweling my body out. I couldn't find out where the blood is coming from. I checked, it's not from my urine, not from my rectum but it was quite a lot of blood drawing out of my body. Immediately, I called my wife into bathroom, then I squeezed my body then the bleeding stops. It was on 24Dec2020. You know my kids were at home. I don't want them to find it. The bleeding stopped and everything went away. Then I thought maybe it is something related to my GI. I went to my GI doctor yesterday to have a checkup, they don't know anything either but I am due for my second dose for next week Wednesday. Now I had this news about thrombocytopenia on this doctor died (Clarification unknown). So I am just afraid if there is anything related this. Do you have any explanation on how I bleed and where it bleed? It was lot of bleeding even my towel was full of blood." Patient wanted to see if anybody else had similar experience or if he get the second dose and he get the complication again. Patient was a medical technologist. He was doing ultrasounds. He was working in a pediatric hospital. Patient was not prescribed/recommended vaccination. "Nobody recommended it. During my hospital. I am healthcare professional. So everybody in my hospital. I just went there and get it. I didn't ask my doctor." Patient added, "You know everything I read about this case and then you know, I have a cut in my leg which is very unusual. I have never seen that. I don't know how it happened. You know all of sudden oneday I wake up and I saw a big cut in my feet also. So, I am just afraid (onset date not reported)." The action taken in response to the events for adalimumab was unknown. The outcome of the events was unknown. Information about Lot/Batch number is requested.

Patient received her second COVID-19 vaccine. Rapid response called when patient returned to vaccine clinic and reported feeling "funny," itchy, and with a blotchy red rash around her neck. Heart rate noted to be 220/109, SpO2 100% on room air. Heart rate of 85. Emergency department PA notes questionable allergic reaction to the vaccine. Very mild erythema at the base of her beck. Given Benadryl, Solu-Medrrol and Pepcid. Heart rate of 183/95 trended down to 157/90 by the time of discharge.

fever 103.8, shaking chills, extreme fatigue, muscle aches, disorientation, skin extremely sensitive to touch

I got the pfizer covid vaccine on 1/18/21 my initial reactions were slight soreness at injection site and a mild headache for 2 days. I took some ibuprofen for the headache. Prior to the vaccination I have not been ill. When I woke up on Sunday morning , 6 days after my initial injection I have a swollen gland on the left side of my neck about 2 " directly below my ear lobe. The swollen gland is mildly sore. Initially i think the size was about 1.75" by 3/4 ". Now on day 4 after it first presented itself the swelling is slowly going down to about 1"x 1/2 ".

Blood pressure was high; tired from the night before; Itchy; slight headache; little lightheaded; Heart racing; panic attack; Hot flashes; Sweating; Chills; achy/body aches; This is a spontaneous report from a Pfizer sponsored program Pfizer First Connect. A contactable consumer reported for himself, a 62-year-old male patient who received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249), via an unspecified route of administration (reported as by injection) to left arm on 14Jan2021 at 3pm at single dose to prevent COVID/COVID-19 immunization. Medical history included anxiety. Concomitant medications included antidepressants. The patient received his first dose of Pfizer COVID vaccine last 14Jan2021 at 3pm, and everything went well. When he left the place, he had a slight headache. He had to stay there for 15-20 minutes to make sure he had no reaction. He just got a little lightheaded, he didn't think much, and it didn't get worse. The patient took 2 paracetamol (TYLENOL) and forgot about it. It went away for a while. He took the shot at 3 pm and he took paracetamol at 4 pm. Later that night, about 10 pm, everything kicked in. He was sick again at 10:30 pm, or so, the headache was gone for several hours. He was ok between 4 pm and 10 pm. Then about 10 to 10:30 pm, when he went to go to sleep, his heart started racing, like he was having a panic attack, then he started getting hot flashes, sweating, chills, and aching, and this went all night from like 10 pm to 11 to the next morning. He had a doctor's appointment to get his knee examined for an upcoming knee surgery. The patient clarified that he didn't go to the doctor because of the symptoms, he went for his knee. He asked the doctor, before getting examined, and the doctor said he got off easy, as the doctor himself was sick for 3 days. The patient asked the doctor if he could take something to calm down, as his blood pressure was high on 15Jan2021 at 8 am. They had taken his blood pressure to examine his knee, and the doctor said it was alright. He was prescribed with alprazolam (XANAX), and the doctor said it would be fine. The next day, he was tired from the night before. He had no symptoms the next day. After he took alprazolam, he slept fine, he felt better. The hot flashes, heart racing, body aches, and chills were gone, and he read everything as far as symptoms. The heart racing went away about 11 the next morning because he took alprazolam. The patient stated that he forgot to add one more, he had all the symptoms described as side effects, but he also had itching. He had very mild itching and was given cetirizine hydrochloride (ZYRTEC, lot number: OHE2723, expiry date: Feb2022, UPC: 4122053077), it was like 80% gone. Every now and again he has a little itch, but it was bothering him all night that first night. Currently, the patient felt pretty good. He has no symptoms other than the slight itch. He further stated that his second dose is on 04Feb2021. Out of all symptoms, the thing that freaked him out the most was the heart racing, he asked if he could take diphenhydramine hydrochloride (BENADRYL) before the shot. He has been on antidepressants for a while, he has a lot of anxiety, but the day he went in, he felt good, and didn't take alprazolam. He also asked if this have triggered all that heart racing stuff. He was seeking for information if there was anything to do to prepare him better, he knew you have to sit there for 15-20 minutes to see if there was a reaction. The outcome of the event headache and lightheadedness was recovered on 14Jan2021, unknown for blood pressure high and tiredness, recovering for itchy, and recovered on 15Jan2021 at 11 am for all other events.

24-hours after receiving second dose broke out with unilateral right sided rash. Rash extended up and down trunk and right arm. Completely resolved with 1 benadryl

Patient developed a rash starting at ankles and spreading up over legs and torso, also slight cough reportedly got worse, but no wheezing or shortness of breath. Patient was given prednisone course 60mg x 2 days, 50 mg x 2 days, 40 mg x 2 days, 30 mg x 2 days, 20 mg x 2 days, 10 mg x 2 days and will follow up

Pt felt arm soreness 4 hours later than felt fatigued, leg heaviness, arm heaviness, and then felt faint with black spots in eyes and numbness down left extremity. Symptoms are still persisting 5 days later today 2/25/21. PT did not knowingly have COVID prior.

One week following second dose, I experienced a urticarial reaction to a meal. I have never had allergies prior to this type of reaction. Upon allergy testing after this event on 2/19/21, an allergy to shrimp was noted. This report is intended to document a brand new food allergy that occurred one week after receiving second dose of COVID vaccine. Treated with one tablet of Benadryl and reaction subsided thereafter.

Broken bones; Fever 102.2; General weakness; Injection site pain; This is a spontaneous report from a contactable other health professional reported for himself. A 62-year-old male received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 16Feb2021 08:15 on Arm left at single dose (Lot # EL9267) for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No allergies to medications, food, or other products. He experienced Fever 102.2, broken bones, general weakness and injection site pain on 17Feb2021, which were non serious. Tylenol were received for the events. The patient had not been tested for COVID-19. Outcome of the events was recovered.; Sender's Comments: The event broken bones was considered as an intercurrent condition and unrelated to the use of BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Soreness at injection site now on third day. Headache within two hours of injection along with mild fatigue for several hours.

Extremely dizzy when got up during night (2 am). Fell twice. Extremely dizzy when got up during night 2nd time (5 am). Fell once. In the morning (about 7:30) I noticed a rash all over his trunk (small pink spots) As the result of the falls, he hit chin and cut it. Hit left temple and bruised it. Back is very sore and painful. May have cracked rib(s). Currently 2:20 pm on March 14. He is no longer experiencing the dizziness. The rash seems to be clearing up (brownish spots instead of pink spots on trunk). He's resting.

By nightfall on the day of my second dose, I was extremely jaundiced. The following morning, my urine was darker than it has ever been - a dark amber/brown color. These are symptoms that I do experience routinely as someone with CAD. Hemolysis causes these same symptoms, but it seems the vaccine accelerated the hemolysis for some reason. Perhaps it activated complement. Regardless, this event did not last beyond the weekend, and has not been an issue since. I just thought it should be recorded as an adverse event.

Significant (2X normal) swelling in two fingers on right hand with dark red/blue areas 1-1.5cm in diameter.

Difficulty breathing, throat swelling (feels like it is) dizziness and weakness, nausea, feeling unwell, fever headache, tiredness and injection site pain

itching nose and had some swelling/welts nose that he could not see but he could feel. Itchy inflamed and swollen left arm distally 3 days after vaccine had some swelling and itching more proximally on left arm 4 days after had itching and welt right side of jaw. No shortness of breath No tingling of lips or tongue No fevers.

Patient reported feeling a "prickly" feeling on his chest and left arm. Patient said "it feels like I fell into a cactus." Patient also reports his face itching. Denies any other symptoms. No bumps or redness observed. After 10 minutes, the symptoms subsided. Instructed patient to call PCP for new or worsening symptoms.

Mild dull headache began about 18 hours post-vax. Unresponsive to OTC pain relief. About 5 hours later, there was an episode of chills, accompanied by severe shaking. Face and neck became very warm and flushed. After about an hour, the episode ended, and even the long-lasting headache felt better. Have not had any adverse effects that were not known to be occurring in some after the 2nd Pfizer vax.

Hives on the head, neck, torso, extremities, 2 fingers left hand and palm of the right hand, there was swelling, lips, swollen jaw, swollen crotches, it is been 4 days.

Extreme intense muscle pain to shot area, left arm, left shoulder around back to the right shoulder. started on 6th day with max pain on 8th/9th day. pain subsiding on day 10. treated with Advil/Acetaminophen Dual-Action and lidocaine medicated rub.

Initial injection site swelling and pain, resolved with cold pack and movement in 2 days. Lymph node swelling in my clavicular and elbow areas with tenderness to palpation which continues through today. No treatment such a heat has reduced symptoms, although initial pain was worse.

1. First shot, no adverse effect. 2. After the second shot I developed chills, aches and a very slight fever within four to five hours of the shot. Later that night I noticed a decided lack of energy and some arm soreness at the shot site when I touched it. The chills and fever subsided after about two to three hours, but the rest of the symptoms continued until I fell asleep around midnight, which was about 12 hours after getting the shot. The aches, arm soreness and weakness all lasted for about a week afterwards, with the weakness being the last thing to go.

PT (DOB 12/14/1958) received the COVID vaccine (Pfizer dose 1, Lot# EW0150, exp 7/31/2021) at 1525. The client reported feeling dizzy and lightheaded, and his caregiver reported that he was "red and sweaty". EMT alerted the RNs and responded to the client. Upon observation, the EMT observed that the client appeared flushed and diaphoretic. The client was accompanied by his caregiver who reported that the client has a medical history of hypertension, orthostatic hypotension, intellectual disability, schizophrenia, diabetes mellitus 2, and bell's palsy. The client has no allergies and takes the following medications: metformin, lipitor. clozapam, metoprolol, cogentin, iron, prostigmine, and farxiga. At 1530, the EMT obtained a blood pressure of 180/118, with a heart rate of 116, respiratory rate of 22, temperature of 99.1 F and pulse oximeter reading of 94%. At 1536, the client's blood pressure was 172/118, with a heart rate of 116, respiratory rate of 20, and pulse oximeter reading of 95%. At this time, the client stated that he was dizzy and feeling anxious. The client reported that he was feeling dizzy before he was vaccinated but that he "forgot" to tell his caregiver. His caregiver reported that the client had not yet eaten or had anything to drink that day. The client was offered and accepted water. The client and his caregiver deferred Benadryl. Repeat vital signs were obtained at 1542: blood pressure of 166/112, heart rate of 116, respiratory rate of 24, temperature of 99.1 F, and a pulse oximeter reading of 95%. The client practiced deep breathing, denied any difficulty breathing, itching or swelling. At 1550, the client reported no longer feeling anxious or dizzy. At this time, the client's color was improved, he no longer was diaphoretic, and he stated "I'm pretty hungry now." Repeat vital signs were as follows: 156/115, heart rate 108, respiratory rate 20, and pulse oximeter reading of 95%. Client left the facility at 1600 after waiting the recommended 30 minutes from initial symptoms, with symptoms resolved at that time. The client ambulated to his car with a steady gait, escorted by the EMT and his caregiver, and his caregiver drove him home.

Considerable pain developed at injection site 6 hours after injection, then extended to pain in neck and lower back. All persisting 10 hours later, but possibly starting to fade. About 10 hours after injection, faint nausea noted for about 2 hours. No treatment sought or administered. Patient is doing physical activity and excercise, and symptoms seem to be fading.

Bell's Palsy; stroke; Minor injection site soreness; Extreme sleepiness (2 days); This is a spontaneous report received from a contactable consumer (patient). A 62-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN6206), first dose via an unspecified route of administration, administered in right arm on 05Mar2021 07:30 as single dose for covid-19 immunisation. Medical history included high blood pressure (HBP) hypertension, Transient ischaemic attack (TIA) twice, pre-diabetic. Known allergies was none. Concomitant medications received within 2 weeks of vaccination included metformin, atorvastatin, losartan, amlodipine, Aspirin (acetylsalicylic acid). The most recent COVID-19 vaccine was administered at work location. 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. The patient experienced bell's palsy (17 days after vaccination - confirmed via ER visit vice stroke) and stroke (seriousness crietria was medically significant), minor injection site soreness (2days) and extreme sleepiness (2 days); all events on 22Mar2021 17:30. The adverse event result in emergency room/department or urgent care. Treatment was received for all adverse events including Steroid/anti-viral medication 7 days by neurologist. The event outcome for all events was not recovered. Follow-up attempts are needed. Information on batch/lot number was available.

Soreness at injection site beginning approximately 5 hours after COVID-19 vaccination.; This is a spontaneous report from a contactable consumer. A 62-year-old male patient received bnt162b2 (BNT162B2, Lot Number: EL 3247), via an unspecified route of administration on an unspecified date (at the age of 62 years) as a single dose for COVID-19 immunization. The patient's medical history was not reported. The patient's concomitant medications were not reported. The patient experienced soreness at injection site beginning approximately 5 hours after COVID-19 vaccination on an unspecified date with outcome of unknown. Information related to batch/lot number has been requested.

Developed Angioedema/hives on leg about 60 hours after 2nd vaccine and severe Angiodema on face/lips about 85 hours after 2nd vaccine

Patient stated that he experienced itching, swelling of the gums and tongue, and difficulty breathing about an hour and half after receiving vaccine. He reports going to Hospital ER on the Road where he was given Epinephrine, Famotidine, Benadryl, methylprednisone, Albuterol, and Racepinephrine . He was transported to the main hospital for further treatment.

The day after receiving my first dose of the Pfizer vaccine, I noticed a rash had started on the right side of my face and also on the third finger (the one closest to my pinky) on the right hand. The rash grew progressively worse over the course of the week, where now it covers a major portion of my torso, forming two triangle-shaped peaks rising from my hip bones to just below the under-arm, a rash running from my left bicep to the first quarter of my left forearm, on my left wrist, on my right wrist, a patch on my right forearm, a patch down the outside of my right leg, thigh to knee, and a small patch under my left knee.

2 hours after shot, hands were itchy...Minor 6 hours after sot, no change 8 hours after shot, hands were very itchy and feet were beginning to itch. Groin are began to itch 12 hours after shot, itchiness was almost unbearable. The more I rubbed or even touched, the worse it got. Rash on inside of legs in groin area raided and itchy. Applied a topical hydrocortisone cream. Seemed to give a little relief...long enough for me to settle down and not rub. 18 hours after the shot, hands were very swollen. Could not make a half fist. Very sensitive to heat.. Continued to apply Cortizone-10 for temporary relief 21 hours after shot, went to Urgent Care. Received a shot of a steroid and a Benadryl Capsule. 25 hours after shot, hands are still swollen. Developed red blotches on the palms of my hands, Some are perfectly cylindrical about 1 CM in diameter. Groin area still blotchy and raised. Does not itch as much as hands. Waiting for relief......

bulging eyes; Mild allergic reaction; metallic taste in mouth; pounding headache; red ears; face/neck rash; fatigue; dizzy.; Sore arm; This is a spontaneous report from a contactable consumer (patient). A 62-year-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Left Arm on 23Mar2021 12:00 (Batch/Lot number was not reported), at the age of 62-years at vaccination, as SINGLE DOSE for COVID-19 immunization. Medical history included enlarged aorta, high blood pressure, asthma, eggs and corn allergy. Concomitant medication included lisinopril taken for an unspecified indication, start and stop date were not reported; losartan taken for an unspecified indication, start and stop date were not reported; amlodipine taken for an unspecified indication, start and stop date were not reported; budesonide (PULMICORT) taken for an unspecified indication, start and stop date were not reported; cyanocobalamin, ferrous sulfate, folic acid, serine (RESCUE) taken for an unspecified indication, start and stop date were not reported. On 23Mar2021 12:00, the patient experienced mild allergic reaction, started with metallic taste in mouth and pounding headache before leaving (pharmacy name withheld) after 15 min wait period, red ears, face/neck rash, "bulging eyes". No respiratory issues. Subsided after <1 hour but still feeling fatigue and dizzy. The patient also had sore arm. Still thrilled to get it. The outcome of the events was recovering. No treatment was received for the events. Information on the lot/batch number has been requested.

'blood pressure had been up to 180/increase in blood pressure'; he was freezing; he was cold; ''he is usually up at work every day and he hasn't been able to work the last few days''; feels like he can't think'', ''tired; ''he may be getting in for breathing treatments today''; so sick; feels like he can't think'', ''tired; Feeling lousy; Lethargic; Running temperature; Chills; Hives; Anaphylaxis; fell asleep for 16 hours. Caller reported that he doesn't normally sleep for 16 hours; Throat scratching; Eye itching; Bags under eyes; This is a spontaneous report received from a contactable consumer (patient). A 62-year-old male received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection, Batch/Lot number: EN6207), via unspecified route of administration on right arm on 19Mar2021 13:09 as a single dose, for COVID-19 immunization. The patient medical history included Ongoing COPD (about 5 years ago), high blood pressure (about 10 years ago and still ongoing) extensive allergies to food and insect bites. The patient was diagnosed with the allergies when he was a little kid, allergic to penicillin ongoing. Concomitant medications included lisinopril at 20 mg once daily in the morning for high blood pressure and albuterol at 2 pumps in AM and 2 in PM before going to bed for COPD (Chronic obstructive pulmonary disease). The patient previously took historical vaccine ampicillin for infection. On 19Mar2021, the patient experienced, ended up feeling really sick right after the shot. He has a lot of allergies and he was advised to take his Epi-Pen kit and stay an additional 30 minutes past the recommended waiting time after receiving his vaccine. His throat began scratching after getting the shot and lasted for about 3 to 4 hours for which the patient received Benadryl and resolved completely. His eyes were itching and lasted for 24 hours, and bags started to form under his eyes like anaphylactic shock. It was reported that the bags under his eyes would normally stay after anaphylaxis for a day or two. His eyes were still a little puffy at the bottom. He did not saw a rash but started to get hives, the paramedics were called and monitored him for another 30 minutes. The paramedics administered a shot of Benadryl. After the Benadryl was administered, his body and blood pressure started to come down. The paramedics reported that his blood pressure had been up to 180. It was reported that on 19Mar2021, afternoon, when the patient got home, he was sick, laid down and fell asleep for 16 hours. He does not normally sleep for 16 hours. He was unsure if his eyes were itchy in his sleep. Later in the call it was clarified that this might have only lasted 3-4 hours, he was so tired he just went to sleep. It was reported that he was not a sleeper, that he was usually up at work every day and he had not been able to work the last few days. It was reported that he started feeling the side effects of the Covid-19 vaccine at 13:20 on 19Mar2021. On 20Mar2021, he felt lousy ever since he received the COVID-19 vaccine. On the same day, his wife took his temperature, and his temperature was hovering around 100-100.9. He felt lethargic, running a temperature between 100.5 and 100.9 pretty consistent every day. On an unspecified date, his wife took his temperature, and it was 99.9. He felt like his mind was in a fog, intoxicated and he had not felt good since receiving the first dose of the Covid-19 vaccine. It was reported that the mental fog made him felt like he cannot think. The paramedics gave him a test and asked him to add 5+7. The patient answered 14, even though he knew that the answer is 12because he could not think, and he felt punch drunk. He reported that he can concentrate a little more, but he still felt drunk, this was hanging around the same now. It was reported that the paramedics were asking him questions and gave him things to do, addition and subtraction formulas, to keep his mind. He could not finish those formulas and that he told the paramedics that he felt foggy or punch drunk. He spoke with his health care provider at the VA and the provider advised him not to get the second dose of the Covid-19 vaccine. It was reported that the patient was inquired if he had any immunity to Covid-19 without taking the second shot and if he was protected with just the one dose of the Covid-19 vaccine. It was also reported that, the reporter also looked through the list of side effects for Covid-19 vaccine and it was like patient had all of them. The patient experienced chills, he was freezing, and he was cold. The patient had the whole list of them. It reported that he had doctor appointment on Monday, 29Mar2021, and that he may be getting in for breathing treatments today. He was waiting for his insurance to finalize the approval for the breathing treatments in the evening. The outcome of the events throat scratching and eye itching was recovered on 19Mar2021, Outcome of the events bags under eyes and blood pressure had been up to 180/increase in blood pressure were recovering. The outcome of the events feeling lousy, lethargic, running temperature and chills were not recovered. Outcome of the other events was unknown. Information on the lot/batch number has been requested. Information on the lot/batch number has been requested.

5-6 inch oval rash around injection site and some additional spots on left side of chest and back. Treated with 2 Benadryl tablets every four hours, four times a day for 3 days. Receded starting after 3-4, by day 8 still visible but nearly gone. Inflammation of lymph nodes under left armpit. Started on 3rd dat post-vaccine and lasted for 36-48 hours

A few days later I got a few small itchy rashes on my right arm (opposite arm of shot). It looks and feels like poison ivy. And I didn't touch anything outside so.assume it's from the shot. I still have it and treatment doesn't help much.

Continued soreness in injection arm every day since first injection. Near-continuous cognitive befuddlement / inability to think clearly - only have had this before with severe sinus infection / head cold (I'm a practicing degree'ed engineer - very scary to me). Had a bout of "double vision" for approximately a minute - never had this before - another very scary thing. Two days ago experienced "highway hypnosis" - zoned out while driving for 10 minutes - lost time event / can't remember driving the route I did - never had this before - another very scary thing.

A rash developed one week after shot starting on my legs and arms and has spread to my upper legs, chest, back etc.

Started afternoon of Apr 16. 100.2 F fever, chills, aches in joints, tiredness, really sore left arm at injection site. Most symptoms gone by afternoon Apr 17.

I developed a 2? diameter area of raised bumps on my lower forearm, between elbow and wrist, underneath side of forearm. Maybe 40 mini bumps in all. Similar to tall pimples or mini blisters, maybe 1/16 inch tall. It was an itchy rash that lasted for a month or so. I received my second dose of the vaccine three weeks after the first dose and had no adverse affects from the second dose. The rash area has scarred now with dark marks on area on forearm. No other after affects.

Acute pain radiating up the neck on the same side as the injection, beginning 30 minutes after jab and continuing. It has now been almost 9 hours. Soreness where the injection was administered beginning 6 hours after the jab.

Multiple red raised bumps like rash in underarm area. No itching. Lasted about 2 weeks. Nothing since 2nd dose

COVID-19 vaccine (Pfizer dose #2) on 4/13/2021. It was injected too high. The injection was given on the left bursae according to the patient's daughter who filed the complaint and is a nurse who also administers vaccines. He is complaining of neck pain. It could be a side effect or as a result of the poor IM injection placement (SIRVA).

Lymph node swelling in Right Shoulder and axillary regions including edema and increased skin temperature/redness extending from axilla into Right pectoral region with pain/discomfort also. Performed gentle lymph drainage massage to Right trunk/shoulder regions and added Lymph Tone II homeopathic drops 3 times daily, with resulting dissipation of fluid in the pec region and decreased soreness.

Second injection on a Friday. Starting Sunday, 4/18, I have had waxing and waning hives - most pronounced at night but also periodically throughout the day. I also had a swollen lip when I woke Tuesday morning, 4/20/21. The swollen lip returned to normal after about two hours and has not returned. I still have recurring hives that wax and wane throughout the day and at night. I do not consider the hives to be a heavy rash. They are itchy enough today that I took a Benadryl. I would have taken one last night, but I had to drive 3 hours to a funeral today. In addition, following the first vaccination (on 3/26/21), I had a swollen lip that night. I did not consider attributing any of the foregoing symptoms to the vaccine until I read about symptoms at about 2 am this morning. The fact sheet given to me when I got the vaccination really doesn't highlight the potential for a swollen lip or the onset of hives a couple days after the injection. I did not have any immediate reaction to the injection (i.e., none during the 15 minute waiting period following either shot).

On the third day following the second dose, a Visible rash of blotches, about the size of a dime appeared throughout the torso from the lower waist line to the armpit on the front and not sides of the torso. The back was clear at almost clear. The rash as persisted. It is now day 9 following the second dose. The rash seemed to fade o day 5 an 6, the the larger blotches became many smaller ones beginning day 7. There has been no sensitivity to the touch or itching. On day 9 a very mild sense of itch emerged

Severe fatigue; Vaccination site pain; This is a spontaneous report received a contactable consumer, the patient. A 62-year-old adult male received the second dose of intramuscular BNT162b2 (solution for injection; Lot EL3248 expiry information not reported) as a single dose in the right arm on 05Janr2021 (at 62-years-old), for COVID-19 immunisation. Relevant medical history included ongoing Hypertension (HTN; 2013), and ongoing Coronary Artery Disease (CAD; Aug2020) with coronary stent. Concomitant medications included sans indications and posology included ticagrelor (BRILINTA) ongoing rom 30Aug2020; lisinopril; acetylsalicylic acid (ASA) ongoing rom 30Aug2020; ergocalciferol (VIT D); and magnesium ongoing from 01Apr2020. The patient previously received COVID-19 immunisation with the first dose of intramuscular BNT162b2 (Lot EK5730) in the left arm on 16Dec2020. The patient reported that on 05Jan2021 he experienced injection site pain and that same day at 13:00 he developed severe fatigue. Treatment for the events included oral paracetamol (ACETAMINOPHEN) 1000mg from 05Jan2021 through 06Jan2021. The outcome of the events injection site pain, and severe fatigue was recovered on an unspecified date in 2021. No follow-up attempts are possible; No further information expected.

On Friday night I noticed my knees were itching terribly. After about an hour, I noticed little swellings all over my body. Taking 2 Benadryl eliminated the itchiness within 45 minutes. After 48 hours, the itchiness still continues, and the Benadryl continues to eliminate the itching.

Patient complained of itching at injection site. Injection site also swollen. Vital signs stable. Patient given 50 mg of Benadryl. After 30 minutes, patient left with no itching and swelling went down. VS normal.

Shingles on left side of face, on upper lip, interior lip, nose, below left eye. Also left eye is aches, like a pulsating headache. Went to Urgent Care 4/28/2021. Prescription issued, Valacyclovir.

Severe Leg pain (especially calves. Both legs equally) Major Leg swelling Elevated D-Dimer Low platelets Elevated Liver enzymes General Body Aches. Shortness of breath Fever Rash Fatigue / Malaise

a couple days later started getting a rash pretty much/ have rash pretty much all over my whole body; hives; he was up until 1:30am for 3 hours on hold last night and didn't get through and fell asleep; The is a spontaneous report received from contactable consumer (patient). A 62-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: EW0150, NDC number: Unknown, UPC number: Unknown, Expiry Date: Unknown), via an unspecified route of administration at left arm on 31Mar2021 as a single dose for COVID-19 immunisation (everyone is saying he should take it). There was no patient history. There were no AE prior vaccinations. There were no prior vaccinations within 4 weeks. Concomitant medications included allopurinol, atorvastatin, gemfibrozil (patient states he takes these). The patient did not receive any other vaccines within four weeks prior to the vaccination. There were no additional vaccines administered on same date of the Pfizer suspect. Patient stated took the Pfizer-COVID-19 Vaccine on 31Mar2021, last Wednesday around noon, a couple days later Saturday morning he was breaking out with hives and rash. Started getting a rash pretty much all over his whole body. As of today, he has a rash, second dose is scheduled for 20Apr2021, Patient asked have other people reported the rash and gotten second dose. Patient states the rash is over his whole body now and he doesn't know if it is clearing up. States he is taking Benadryl, that he called his doctor and was told to take Benadryl and see what happens. Patient states he has some questions, he is wondering if he should take something else and he is scheduled for his 2nd shot and he needs help with what to do. Patient relays that it seems the rash may be drying up a little and is wondering is he should still get the 2nd shot. Patient relays that the rash started about 48 hours later on 02Apr2021 in the evening, Saturday, Sunday and a little worse yesterday and today he doesn't know if it is drying up but he still has it all over his body. States the card says 0.3mg and believes that is the dose. Patient asking if his healthcare provider is going to know any information as it's a brand-new drug, states he has 3 friends that are doctors and they have all said to call Pfizer. Patient was asking if other people have reported this. Patient states he was up until 1:30 am for 3 hours on hold last night and didn't get through and fell asleep. Report was not related to a study or programme. There was no investigation assessment. The outcome of event was unknown. No Follow-up attempts are needed. No further information is expected.

Patient presents with a potential reaction to the COVID19 vaccine. Patient-reported vague symptoms of some RUE tingling and R-sided facial tingling after RUE injection along with some neck tightness. The patient also reported mild generalized itching without rash, which he felt may be due to seasonal allergies. He requested 50mg oral Benadryl. Oral Benadryl given per request. Returned to baseline with monitoring.

Hives left hand, left cheek bone and then profound fatigue, bad insomnia and restlessness, severe bone pain in right foot and right arm; heart palpitations and fast heart rate with dizziness and nausea; headache; Day 8 started having muscle twitches and cranial/ear buzzing; Day 8 experienced severe malaise and nausea and lightheadness; Day 18 difficulty walking in straight line; muscle twitches with heart palpitations very bad in evening; localized headache at left temple area, stiff neck and shoulders; eye vision blurry with heavy floaters and eye socket pain; extremely vivid dreams

severe cramps in calf's and thighs; cramps as bad as bruises and calf's bruise; This is a spontaneous report received from a contactable consumer (patient). This 62-year- old male patient received his 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number ER8733) at single dose via an unknown route in left arm on 09Apr2021 for Covid-19 immunization. Medical history included anxiety. Concomitant drugs included cariprazine hydrochloride (VRAYLAR), amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), clonazepam for anxiety. Patient had been having severe cramps in calf's and thighs in Apr2021. Patient had a shot on "Friday" and it started "Tuesday" (also reported as "may be 12 or 13Apr") night. Patient had been having cramps as bad as bruises and calf's bruise and the muscles "that are lined". No treatment received. Outcome of the events was unknown. No follow-up attempts are needed. No further information is expected.

This is a spontaneous report from a contactable consumer (patient). A 63-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration (reported as "hypodermic needle"), administered in arm left on 25Mar2021 (Batch/Lot Number: EN6206) at age of 62-years-old as single dose for covid-19 immunization. Medical history included atrial fibrillation from Sep2016 (Diagnosis date: Sep2016). Concomitant medications included diltiazem taken for an unspecified indication, start and stop date were not reported; metoprolol taken for an unspecified indication, start and stop date were not reported; acetylsalicylic acid (ASPIRIN) taken for blood thinner, start and stop date were not reported; pravastatin taken for blood cholesterol, start and stop date were not reported. The patient received first shot on 25Mar2021. On 02Apr2021, the patient got shingles and his foot swelled up, his left side throat swelled up, the patient had shingles in his left arm pit and his left shoulder blade and now the patient do not get shingles. On his left armpit, the patient got a patch of shingles or hurting "roster" (not clarified) and also his left shoulder blade the patient got a patch and the same thing. His left foot swallowed up, it may or may not be related but it had appeared, had all appearances of very bad gout flare up, the patient couldn't walk in his whole foot and lower part was completely swollen, the patient didn't know this was related or not but the time being, the patient can't. The patient would like to report it and want to know. The rash on his body is still has but was subsided now, it was tolerable now. The patient was putting a topical cream on his armpit and shoulder. It was a burn cream, twice a day, it calls for at least twice a day. Outcome of the events was recovering. The patient got his bnt162b2 second shot (LOT#ER8729) on 15Apr2021. No follow-up attempts are needed. No further information is expected.

a bump with fluid, like a chicken pox bump at the site of the shot; a bump with fluid, like a chicken pox bump at the site of the shot; bump broke and fluid came out of it; This is a spontaneous report from a contactable consumer. This contactable consumer (patient) reported that a 62-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8729) at the age of 62-years, via an unspecified route of administration in right shoulder on 12Apr2021 09:30 at single dose for COVID-19 immunization. Medical history and concomitant medications were reported as none. No other vaccinations within four weeks prior to the first administration date of the suspect vaccine. The patient historically received first single dose of BNT162B2 for COVID-19 immunization and had no problems. Patient stated that there was a bump with fluid, like a chicken pox bump at the site of the shot, no other redness. Stated later that night bump broke and fluid came out of it, he put a band-aid on it, it may have a scar later. The events occurred 13Apr2021, no emergency room, no physician office. Outcome of the events was not recovered/not resolved. No follow-up attempts are needed. No further information is expected.

7:45am April 13th, 2021 at hospital I was very excited to finally get the vaccine ...I was given the Pfizer shot in my upper left arm and felt small pain a the site of injection ...In 5 minutes I felt nauseated, very dizzy and weak to the point of falling off the chair ...they gave me two cups of orange juice and a few fig bars in the hopes that I was just having low blood sugar ...I was offered a hospital bed to lay down ...I experienced numbness in my left arm and in both hands ...also across the lower part of my face ...I was at the hospital for over an hour an was unable to return to work ... A few days later I began experiencing high pitch ringing in both ears that has gotten worse to the point of being so loud I can't hear a person talking to me on the phone ...noises around me are extremely painful to my inner ear ...this high pitch sound wont go away and keeps me up all night ...I have been to the hospital several times to see ENT doctors and I have tried many medications to help me sleep with this 24/7 tortuous ringing sound ...I can keep myself busy all day trying to ignore it yet at night it haunts me like a demon ...please contact me with any help you know of to reduce this sound in my ears ...I am extremely desperate for sleep ...

Soreness on the around the shot site; Severe arm pain up where the rotator cuff is; Severe arm pain up where the rotator cuff is; Has not slept due to pain; cannot sleep, the pain wakes him up; Could not use his arm; 50% deficit with the use of his left arm; After the vaccine, he could not lift his arm above his mid face level; Burning and tingling down the left arm; went to his hand and fingertips and progressed to the whole left side of his body including his rib line, hip, leg, and foot; Burning and tingling down the left arm; went to his hand and fingertips and progressed to the whole left side of his body including his rib line, hip, leg, and foot; Nauseous; This is a spontaneous report from a contactable consumer (patient who is a retired paramedic). A 62-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: ER8732), via an unspecified route of administration in left arm, on 30Mar2021 at 01:00 PM (13:00), as first dose, single, for COVID-19 immunization. The patient's medical history included bipolar depression from probably 10 years ago (2011) and ongoing, torn rotator cuff (15 to 20 years ago), and food poisoning in mid-Aug2020 (maybe it was more than that; may get tested to see if he ever had COVID-19). The patient's concomitant medication included vilazodone hydrochloride (VIIBRYD) from 2017 and ongoing (for at least four years) for bipolar depression. The patient has no known allergies. The patient was one of those people who doesn't get sick and he doesn't normally get the flu shot and everyone told him to get this Pfizer vaccine. The patient was not panicking but got the first dose of the Pfizer Vaccine on Tuesday (30Mar2021) around 01:00 PM and saw some things about having soreness on the around the shot site and all of that from that night (30Mar2021). This is going on for three days (from 30Mar2021) with severe arm pain up where the rotator cuff is; if you ever have pulled a rotator cuff it feels like that and he has not slept in almost 3 days due to pain from 30Mar2021. The pain is severe at times that it makes him nauseous (Mar2021). He figured the soreness was normal and later in the evening on 30Mar2021, the pain became an issue when he tried to go to bed that evening. Since the first two nights compared to last night, the soreness is actually improved; every time he tries to sleep with pain as a factor it is not easy. The patient can feel throbbing with his heartbeat and with the circulation there is throbbing pain. The pain was terrible and was throbbing like his heartbeat and similar to like a shoulder rotator cuff injury. For the first two days, on Tuesday (30Mar2021) and Wednesday (31Mar2021) after the vaccine, he could not use his arm or lift his arm above his mid face level. According to the patient, it was like a rotator cuff and he had a torn rotator cuff 15 to 20 years ago and this is the same arm that his torn rotator cuff occurred in; this is very painful and he is comparing it to the torn rotator cuff. In Mar2021, the patient had burning and tingling down the left arm and 3 days no sleep because the pain is worse at night. During the last week (Mar2021), his left leg down to his foot is also tingling and burning. The patient's primary care physician just retired, and he is in the process of finding a new one. The patient had no treatment or physician or emergency room (ER) visit for the reported events because being in the ER field, he can tell right now that it would be a waste of time of the effort to go into the ER as they would do nothing but tell him to take paracetamol (TYLENOL) and that is it. The patient did not like to take paracetamol and hates taking paracetamol. The patient clarified it is generic acetaminophen extra strength (Strength: 500 mg; Lot Number: P119682, Expiration Date: Mar2022, UPC Number: 5084417594) that he has taken (maybe every 6 hours oral) and it does relieve the pain so that is only so good. He does not know if in motion of the course of the day, something happened because at night laying still in bed is when he has pain. The patient did a lot of research before he made this call and the severity of the pain is enough to actually keep him awake for three days. He thought it was severe pain; maybe he should have told them to administer the vaccine in his right arm, but it was administered into his left arm. The only reason he made this call was because he wanted someone to know what he was having which could be just completely normal and he is sure every reaction is different and he expected the soreness because he remembers as a kid having shots. Also, this level of pain he is experiencing is what he wanted to report; imagine having himself going three days without a full night of sleep and he wanted to report this to make sure Pfizer knew this if they were keeping track of numbers of how many people have a similar pain level. The patient also asked if there were other people who called and reported these symptoms and if there is any information or treatment recommendations. As of 08Apr2021, even up to five days after getting the shot, now going on seven days that he has had some pretty severe reactions. The patient called in after 3 nights of getting no sleep. The patient was calling today to see if someone was ever going to call him back and asking will there be a follow up call from someone to see if he's still alive. The patient had some pretty severe reactions and they have actually gotten worse. There also have been new developments. The patient had pain in his arm that pulses along with his heart rate. It is so bad that it kept him up for 3 nights and still wakes him up at night. The pulsing pain in his arm started on the first night and has gradually gotten worse. The pain in the arm that is enough that it keeps him awake at night only starts getting severe when he goes to bed. He has tried sleeping in an upright position and he has tried everything, and nothing seems to alleviate it. The patient took generic acetaminophen which did not work during his last phone call. The patient also tried naproxen sodium (ALEVE) and that doesn't work wither. It was absolutely debilitating at times to where he has a 50% deficit with the use of his left arm (Mar2021). The patient initially reported burning and tingling sensation that was on his left arm and went to his hand and fingertips but now it has progressed to the whole left side of his body including his rib line, hip, leg, and foot. He is a retired paramedic and is pretty sure he is not having a long stroke. The patient feels it is too long to have symptoms from a shot he got. The patient has a lot of friends in the medical field and he's been told even going to a primary care physician, it is kind of gray area when it comes to dealing with COVID-19 vaccines. The patient was having second thoughts about getting the second shot. He had been told he can take NSAIDS over the counter for pain which has not helped him; there is no protocol for diagnosing or treating anything that happens from the shot. People in the medical field have told him there is thin line now to treat side effects because of liability; some doctors won't even get into it, just refer to Pfizer because medical insurance will not cover any services related to COVID-19 vaccine reactions. The patient continues to explain that is why the federal government is the only one that owns the shot due to liability. The patient's main concern is calling and reporting and maybe getting some help in deciding whether or not to get the second dose of the Pfizer COVID-19 vaccine. In his opinion, that is too long to have pain that he cannot sleep, the pain wakes him up. This all happened along with the shot, the same night and there are times where he can't work due to it. The patient asks if anyone is concerned with it and will someone feel bad because he doesn't get the second shot. His main concern is that people are underscoring or even lying about side effects, stating he can't believe he is an isolated case. The patient continued to ask if this is something he's stuck with, or if it is something he would have to deal with from now on from getting this shot. The patient regrets getting the first shot and stated that if he knew then what he would be going through now, he wouldn't have got it. The patient has no sort of history of being a hypochondriac and the feelings he is going through right now are sensations that he has never felt in his life. The patient continues to explain he doesn't even know how to categorize it other than mentally relating it to the shot since it all occurred in line with Mar2021 getting the shot. The patient further commented that if he ran a call with an ambulance right now with a patient telling him what i he was telling the company, he wouldn't even know what to do with them other than getting them comfortable and to a hospital. The patient had not recovered from "Soreness on the around the shot site", "Severe arm pain up where the rotator cuff is", and " Has not slept due to pain; cannot sleep, the pain wakes him up". The outcome of the other events was unknown.

- Instantaneous sharp pain throughout the shoulder region (not experienced during initial vaccination shot, 3 weeks earlier in same shoulder). - Subsequent loss of use of left arm for 2-plus days (any motion caused inflammation to spike in shoulder, centered on one muscle but radiating throughout). - No treatment other than limitation on use of arm, very gradual reintroduction of usability. - Gradual recovery over several weeks. Now 18 days out from second shot, about 98% recovered from shoulder injury.

Patient states he felt some diffuse palpitation did not feel right and wanted to get himself checked. On arrival patient is somewhat anxious has some diffuse skin erythema over the chest wife is not sure if that is at baseline or if its new. Patient denies any shortness of breath states his chest felt funny earlier but has no symptoms at this time. Reported SOB earlier. Patient is having hiccups. Patient has no emesis has no respiratory difficulty denies shortness of breath saturations are 98% on room air with respiratory rate of 20. Patient has no abdominal pain no other rash to the abdomen torso extremities etc. Patient had first vaccination with no allergic reaction. Patient denies any history of allergies to medication. Patient is symptom free and is able to give good history no change in voice no neurological symptoms. Patient treated with diphenhydramine 25mg IV x1, Famotidine 20mg IV x1, Lorazepam 0.5mg IV x1, Methylprednisolone 125mg IV x1; Discharged to home with prescriptions/ OTC for Epinephrine 0.3mg/0.3ml IM, Famotidine 20mg po , Benadryl 25mg po

Rash on arms, hands, legs, feet, and a little bit on chest.; The worst part was that his groin swelled up to about the size of a Cantaloupe.; lost about 60-70 pounds in water weight.; fisrt dose on 20Jan2021/second dose on 06Feb2021; fisrt dose on 20Jan2021/second dose on 06Feb2021; This is a spontaneous report from a contactable consumer(patient). A 62-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in Arm Left on 06Feb2021 15:00 (Lot Number: EL9261) as 2nd dose, single for covid-19 immunisation. Medical history included diabetes, High Blood Pressure, Obese. Concomitant medication included 17 medcations (unspecifed). The patient previously took first dose of bnt162b2 (lot number: EL3249) on 20Jan2021 at age of 61 years old, administered in Left arm, for covid-19 immunisation. The patient previously took lithium. The patient reported rash on arms, hands, legs, feet, and a little bit on chest. The worst part was that his groin swelled up to about the size of a Cantaloupe. He was catheterized in the hospital and over a period of about two weeks he lost about 60-70 pounds in water weight. The adverse events occurred on 07Feb2021. The adverse event resulted in emergency room/department or urgent care. Catheterization and Furosemide were received as treatment for the adverse events. The outcome of events was recovered with sequelae. Follow attempts are needed. Further information is expected.

Developed itching on day of 2nd shot. Then developed rash on chest, back, neck, shoulders, arms. He was treated at Clinic with Keflex and prednisone for Folliculitis & then by his PCP with Doxycycline for bacterial or Pityriasis rosea. Rash & itching continued & he was seen on 5/13/21 & treated with Tetracycline cream & Allegra. Biopsy consistent with Hypersensitivity Reaction. Rash is improving.

5/11/2021 DEVELOPED WHAT HE DESCRIBED AS RED BLOTCHES THAT BECOME MORE PRONOUNCED ON HIS CHEST. HE APPLIED BENADRYL TOPICALLY. ON 5/20/2021, AGAIN DEVELOPED BLOTCHES ON HIS THIGHS AND ALSO STATED THAT THE RIGHT SIDE OF THIS FACE WAS SWOLLEN & FELT LIKE HIS LIPS WERE BRUISED. HE FILLED OUT A VAERS REPORT 525166 ON HIS OWN ON 5/20/2021.

3/26/21 After Pfizer vaccine noticing hives on chest and left arm as well as facial tingling and slightly left eye itchiness. Received 2 dose of Epinephrine during ED visit. 5/13/21 After Janssen vaccine he received at this morning around 8:10 AM. After that he had almost the exact same symptoms with a shooting pain in the left arm and neck some left hand tingling and swelling to the point where he can't get his wedding ring off and a sensation of pressure/tingling/fullness in the left side. Given Benadryl and steroids, initially there is no airway concerns or compromise. However after a period of time, he thought his voice was different. He did sound just slightly raspy, though I did question whether this could be related to dryness from the Benadryl. Regardless given that he did note a change, we opted to go ahead and give a dose of epinephrine, which did resolve his symptoms

Eight days after getting vaccine developed itchy rash in region of right upper side area, under arm pit. This was diagnosed as shingles on 5-31-2021. Acyclovir and Lidocaine cream prescribed to use for 7 days. Second dosage of vaccine rescheduled.

He got his vaccine, within 15 minutes he was staring, and was offered something to drink and some graham crackers and his wife said and the nurse came over to see what was going on, and said that he had an absent seizure, he was not responding to anything. His oxygen was 93, his BP dropped. The nurse was watching his eyes to see if there was any reaction, but there was not. They kept talking to him until he responded and he had no idea of what happened. He has not had any more seizures. He has never had any seizures in the past. He came out of it and they did not take him to the ER. He is fine now. He currently has cellulitis around his eye.

having a pain in my left hand that I took the vaccine and that is more in the muscle, muscle pain and joint pain; having a pain in my left hand that I took the vaccine and that is more in the muscle, muscle pain and joint pain; The pain is increasing it is really getting worse; I cannot eat from my hand at the back, I cannot lift anything; having a pain in my left hand that I took the vaccine and that is more in the muscle, muscle pain and joint pain; This is a spontaneous report from a contactable consumer (patient). A 62-years-old male patient received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER8729 and Expiration Date: 31Jul2021) via intramuscular route in the arm left on 10Apr2021 as 2ND DOSE, SINGLE for COVID-19 immunization. The patient medical history included diabetes and Blood pressure high. The concomitant medications included metformin hydrochloride 1000mg, sitagliptin phosphate monohydrate 50mg (Janumet XR) and Glimepiride 1mg tablet (taking half because diabetes was not that high) taken for diabetes mellitus the morning and in evening and taking for 7 years, lisinopril taken for High blood pressure taking for 3 years, tadalafil; the patient went in surgery in 2020 (start feeling the excursion) So that time the patient was taking medication so would say 3 months and having appointment to continue or discontinue. After that the only thing the patient was taking tadalafil. The patient historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: N6207 and Expiration Date: 31Jul2021) via an unspecified route of administration on 20Mar2021 for COVID-19 immunization and experienced no adverse event and in 2008, flu shot (lot number and expiration date was unknown) for immunization and experienced was sick, got sick and flu or fever or headache (After that did not take the shot again). On 10Apr2021 after the 3 weeks of first dose the patient received second dose of vaccine and waited for like 20 minutes before leaving the facility, the hospital, and like on third day (may be on 13Apr2021) the patient experienced having a pain in my left hand that I took the vaccine and that is more in the muscle, muscle pain and joint pain. The patient reported that, the pain was not that severe and did not have fever, headache and any other side effect at all. It was just the pain 3 days after, and then it did continue to increase and maybe like one week of joint pain because of that injection and it continue. The patient was feeling pain and then by May2021, the pain was like most and stated that I cannot eat from my hand at the back, I cannot lift anything, so that was new problem, the patient cannot lift anything and cannot turn hand at the back. The patient reported, it was not that very severe that I cannot eat and not that harsh, it was just in the joint and in the muscle. The patient reported, the first day and second day was not that much, the third day was when he started really experiencing and one week after he really feel it. The patient reported that, the pain was increasing. The patient was trying to see maybe within 1 week, within 2 week and within one month but now on 02Jun2021, it was really getting worse, and this was his experience. The patient started really feeling it and thought maybe after 2 weeks it will be going to be over, but it continued, so when it continued, he decided to go to the hospital and so they told me that. The patient took Tylenol and then kept taking Tylenol until for one month after it was lie if he was taking Tylenol it not really hurt maybe it was coming back, he cannot lift of his hand at back and cannot lift anything, the pain was not that kind of pain that it why I was taking. The patient reported that, the pain was continued. On 23Feb2021, the patient underwent laboratory tests, it was a general check-up for Diabetes to check it once and see the kidney, the blood pressure, everything the doctor was checking and then the physician said that that they wanted to check his system the blood work, they did find out that he had COVID 19 symptom on it. Physician told it was not positive. The physician told that, the patient has a strong immune system and if he tested positive, he would not feel anything, and physician told everything was excellent. The patient reported that, he took Tylenol 500mg, and that medication he always takes if he has too much pain. The patient reported that, he takes 2 tablets twice a day and sometimes 3 times in a day, sometimes 2 times in a day. The outcome of events was unknown. Information on Lot/Batch number was available. Additional information has been requested.

42 days post immunization, pt still experiencing sore shoulder with a swollen "bump" at injections site

Swollen lymph nodes at jaws; rash on stomach; This is a spontaneous report from a contactable consumer (patient). A 62-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number and expiration date were not reported), via unspecified route of administration in the right arm on 12Mar2021 11:00 AM (at the age of 62-years-old) as first dose, single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. No other vaccine was received by the patient in four weeks. The patient had no COVID prior vaccination and was not tested for COVID post vaccination. On 13Mar2021 13:00 PM, the patient experienced swollen lymph nodes at jaws and rash on stomach. It was unknown if treatment was received for the events. The adverse events resulted in doctor or other healthcare professional office or clinic visit. The outcome of the events was not recovered. No follow-up attempts are possible; information about the batch/lot number cannot be obtained. No further information is expected.

painful left arm/shoulder where shot was administered; painful left arm/shoulder where shot was administered; Hard to lift up arm, nothing noticeable on arm; bloodshot eyes; muscle aches; unable to take full breathes/shortness of breath; minor cough; migraine headache; chills; exhausted; aches; nausea; covid like symptoms; body aches; low energy; This is a spontaneous report from a contactable consumer (patient). A 62-years-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 03May2021 15:30 (Batch/Lot Number: EW0173) as single dose for covid-19 immunisation. The patient medical history was reported as none. Patient had not any known allergies. Patient had not received any other vaccine in four weeks nor received any other medications in two weeks. The patient did not received concomitant. The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: unknown; Expiration date: unknown) via an unspecified route of administration, administered in Arm Left on 05Apr2021 07:30 PM, as single dose for COVID-19 immunization. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. 2nd shot administered on 03May2021 and on 08May2021 09:00 PM six days later developed migraine headache, chills, exhausted, aches, nausea. Chills, migraine, lasted 1 day, night of 08May2021- 09May2021. It was reported that due to lifting weights, vaccine was trapped in the arm/shoulder muscle, released slowly where he developed covid like symptoms 6 days after shot followed by week of covid like symptoms, shortness of breath, body aches, exhausted, low energy. Week of 10May2021 exhausted, bloodshot eyes, muscle aches, unable to take full breathes, developed a minor cough. On 15May2021- 16May2021, painful left arm/shoulder where shot was administered. Hard to lift up arm, nothing noticeable on arm. No treatment was received for the events. The seriousness of events was reported as non serious by the reporter. The outcome of the events chills, migraine were recovered on 09May2021; events painful left arm/shoulder where shot was administered and hard to lift up arm were recovered on 16May2021 and recovering for other events.

Injection site pain; Severe chills; Joint pain; Muscle pain; Low grade fever; This is a spontaneous report received from a non-contactable consumer, the patient. A 62-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6198), via an unspecified route of administration in the left arm on 15Mar2021 at 10:00 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. 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 previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6200), via an unspecified route of administration in the left arm on 25Feb2021, as a single dose for COVID-19 immunisation. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6200), via an unspecified route of administration in the left arm on 25Feb2021, as a single dose for COVID-19 immunisation. On 15Mar2021, the patient experienced injection site pain, low grade fever, severe chills, joint pain and muscle pain. The patient reported injection site pain for 3 days, low grade fever for 2 days, severe chills for 3 hours occurring approximately 14 hours after injection, joint and muscle pain for 2 days. The patient did not receive any treatment for the reported events. The clinical outcome of the events injection site pain, severe chills, fever, joint pain and muscle pain was recovered. No follow-up attempts are needed. No further information is expected.

Coronary artery disease; mild tenderness of the injection site of right deltoid; This is a spontaneous report from a Pfizer sponsored program from a contactable consumer (patient). A 62-year-old male patient received bnt162b2 (reported as Pfizer Covid-19 Vaccine), dose 1 intramuscular, administered in deltoid right on 18May2021 14:00 (Batch/Lot Number: EW0172) as 1st dose, single at the age of 62-year-old for covid-19 immunisation. Medical history included essential thrombocythaemia from May2014 and ongoing (Outpatient at withheld since 2015 for this condition. This is a myeloproliferative disorder where bone marrow makes too many blood platelets. Previously on chemotherapeutic agent hydroxyurea from time of diagnosis May2014 until 29Jun2020. Has not been on any other medication since then except low dose aspirin), chest pain, headache, and nausea from 2021 (all started approximately 4-6 weeks prior to 20May2021). The patient's concomitant medications were not reported. The patient previously took acetylsalicylic acid (ASPIRIN) (reported as Low Dose Aspirin) at 81 mg from May2014 and ongoing for essential thrombocythaemia, hydroxycarbamide (HYDROXYUREA) for essential thrombocythaemia from May2014 to 29Jun2020 (Previously on chemotherapeutic agent hydroxyurea from time of diagnosis May2014 until 29Jun2020). Patient received the first dose of bnt162b2 18May2021. From 20May2021 to 25May2021 he got hospitalized and took a blood thinner for 5 days. He is scheduled to receive the second dose of bnt162b2 on 08Jun2021. He wants to know if he can still get the second dose of bnt162b2 if he took the blood thinner for 5 days when he got hospitalized. Patient clarified that he was administered his first dose of bnt162b2 on 18May2021. He reported having chest pains, headaches and nausea that all started approximately 4-6 weeks prior to 20May2021 which was the date he was admitted to the hospital relative to those events. He specified that these events were ongoing prior to him ever being administered the bnt162b2. He was admitted to the hospital on 20May2021 until discharged on 25May2021. He has had no further episodes of these events, but whether recovered completely or with lasting effects is unknown. Patient is a retired medical laboratory technician, has a degree, has worked in medical labs in the past but is currently retired. Admitted to hospital as cardiac patient with no cardiac history prior to initial onset of these events around 4-6 weeks prior to 20May2021. He was brought to the hospital emergency department via ambulance that he himself called. While hospitalized they recommended surgery to him, he declined surgery, left the hospital and is seeking another opinion. While hospitalized he was administered blood thinner or anti-coagulant Heparin intravenously. He was not sure if he started Heparin on 20May2021 or 21May2021, but thinks it was from 21May2021 to 25May2021. He thinks he was brought to the hospital and admitted somewhere between 22:30 on 20May2021 and 00:00 21May2021; but verified hospitalization repeatedly as starting 20May2021. Patient provided additional details regarding these events: about 4-6 weeks prior to 20May2021 he had been having rather severe headaches, nausea and chest pain-not constantly, but having them. He had been able to function, in other words take care of himself, do business although sometimes a bit difficult and uncomfortable because of those symptoms but got it done. On 20May2021 when this continued he had been pretty busy that day out from about 10:00 or 11:00 until about 21:30. He accomplished everything he wanted to do that day, had eaten a couple of times. He had no headaches that day, had some chest pains, nausea but at end of day when he came home about 21:30 he had the worst chest pain of the day. Because he had been having these types of symptoms: headaches, nausea, chest pain for 4-6 weeks before that, he called ambulance went to local hospital called his primary doctors' office before he did that; and so they agreed he should go so he did. The tests that were performed were amongst many blood tests from CBCs to chemistry to PTT to a PTT because he had been put on heparin particularly. Maybe a lipid profile type test, was given an echocardiogram and an angiogram. Put on a cardiac unit; no prior cardiac history or heart problems prior to this. Regarding results they were saying he had coronary artery disease; that had 3 modes of treatment: anything from medication regimen only to stent to bypass or open heart surgery so that's the sort of testing that was done. He never looked, he's going to get records in the future. He has been a medical lab technologist he knows how to draw the labs; he knows what the purple top for CBC with or without diff is; he knows EDTA ethylenediaminetetraacetic acid is, he knows the light blue top is gonna be sodium citrate for coagulation studies for prothrombin time etc.; he knows the red topper is maybe chemistry; so know those kinds of things, he knows how to perform venipuncture blood sample, finger stick and heel sticks. He had no history of cardiac problems other than what appears to be going on now; never been on anticoagulant before this hospitalization. He does not believe the chest pain, nausea and headaches are attributable to the vaccine; he is not going to say it couldn't be that; but on the surface he does not think the vaccine had anything to do with the events-events were going on before he got the bnt162b2. At the time he got the bnt162b2 he believes he mentioned having essential thrombocytosis and may have mentioned that he was an outpatient at that facility. He also mentioned he had mild tenderness of the injection site of right deltoid; but that is common and expected with any intramuscular injection; he did not notice any other types of side effects he could attribute to the vaccine. The mild tenderness of the injection site of right deltoid onset date and time was immediately or shortly after the time of injection on 18May2021 and only lasted about a day, stopped about 19May2021; event was nothing unusual. Unknown if recovered completely. Product name repeatedly verified by patient. Patient provided additional details from CDC vaccine record card: Vaccine first dose Covid-19 product name/manufacturer lot number: the following information was handwritten into the card by the people who administered the vaccine to him: Pfizer EW0172. Covid-19 vaccination record card. date administered: 18May2021. Facility: withheld-which he later referred to interchangeably as withheld. When he received initial dose on 18May2021, outside of the CDC vaccine record card, he was given future appointment card and a multi-page document all together titled Fact Sheet for Recipients and Caregivers; and in that information, that's how he came to call Pfizer. There's a telephone number inside, on page 5 of this document; in the section titled additional information it says if you have questions visit the website or call telephone number provided below: withheld that's how he got the number to call Pfizer. On page 2 of that same document section: What you should mention to your vaccination provider before you get the Pfizer-BioNTech Covid-19 Vaccine? Tell the vaccination provider about all of your medical conditions, including if you have any allergies, have a fever, have a bleeding disorder or are on a blood thinner, are immunocompromised or are on a medicine that affects your immune system, are pregnant or plan to become pregnant, are breastfeeding, have received another COVID-19 vaccine. What prompted him to call was on and before 18May2021 he had not been hospitalized; he was not having any bleeding disorder or on any blood thinner. He gets the first dose on 18May2021 he is scheduled for second dose on 08Jun2021 about 21 days after the dose at same place; what prompted the call today is, he was hospitalized with chest pains. During that hospital stay was on Heparin. He was not diagnosed with any bleeding disorder. He has no longer been on any blood thinner of any kind since 25May2021. So his question is given the fact that he is scheduled for the second dose, should he still get the second dose of bnt162b2 or not. He does not want to wait until he goes back to the healthcare facility to ask them that question. As far as he knows it now, he is not seeing any other reason he could not get the second dose of bnt162b2 as scheduled. Of course that is considering that nothing else happens in the interim but he does not foresee anything happening. He does not know what time it takes for Heparin to get out of your system, hasn't researched that yet. Heparin: Lots/NDCs/Expiries: Not provided, administered in hospital. Chest pains, nausea, headaches require a visit to emergency room, the patient was hospitalized, from 20May2021 to 25May2021. Patient called in and stated that he received the fact sheet after receiving the 1st dose last 18May2021 and he noticed that there's a certain part in the fact sheet that what you will tell your vaccination center. He mentioned that he is not in a blood thinner when he received the 1st dose and after that he got hospitalized for 5 days from 20May2021 up to 25May2021 and during those days he was in a blood thinner. Now he wants to know since he will be receiving the 2nd dose on 08Jun2021, is he eligible to get the vaccine since from 25May2021 until now he is not in a blood thinner. Patient stated he received the first dose of the bnt162b2 on 18May2021 and he is scheduled to receive his second dose on 08Jun2021. Two days after his first dose, on 20May2021 he was hospitalized, he stated that he was experiencing symptoms even before receiving the vaccine, like headache, nausea and chest pain. He went to the ER on 20May2021 to get evaluated and treated and he stayed in the hospital for 5 days, from 20May2021 to 25May2021. During his hospitalization he was administered IV heparin, he hasn't received any since the got out of the hospital on 25May2021. He is not taking blood thinners currently and he does not have a bleeding disorder, but he read on the Fact Sheet for Recipients and Caregivers to mention the vaccination provider all your medical conditions including if you have a bleeding disorder or are on a blood thinner. Should he receive the second dose of the vaccine as scheduled? Patient stated he is 100% sure his hospitalization is not related to the vaccine since he had the symptoms before. He also stated that he did not experience any side effects after receiving the vaccine and that the hospital staff is aware that he received the first dose of bnt162b2 on 18May2021. The patient was recovered from mild tenderness of the injection site of right deltoid on 19May2021. The outcome of other event was unknown.

As soon as she did the injection I can feel the med going into my arm and it started tinging and I stayed for the 15 mins and then my hand and arm started feeling numb. During the 15 mins I was waiting I ask the guy do this suppose to happen and he said that after the 15 min way, it should go away. An then the next day my hand was still hurting and the next I called my PCP and said, nothing that we can do. An then I waited and I called a doctor friend at Clinic and take Claritin because it was itching and so he said to try calamine lotion. It seemed to help but I would still have the numbing feeling. It felt like nerve damage. So I called Dr. and she gave a prescription for Betamethasone Dipropionate cream USP (Augmented). It has helped but it is still there on my arm. I can only use it for 2 weeks. It has only been a week. So, we will see what happens.

I had pain in my injection site and it has subsided but literally for 4 months from march until early June I had pain at the injection site. I had an acupuncturist come and massage the injection site. I went to my doctor and she took an MRI and my whole left hand tingles. I still have a slight tingle now. I had to get a pain killer because I had to take the MRI and I lay on my left shoulder and I could not move but it was painful so I took the pain killer. As the pain has subsided the tingling has increased. What my doctor said is that I was injected in my rotator cuff.

COVID-19 virus test positive/lost sense of taste and smell but that was it; COVID-19 virus test positive; Vaccination site pain/Sore arm; This is a solicited report from a Pfizer-sponsored program received from a non-contactable consumer (patient) based on information received by Pfizer from(Manufacturer Control number 21K-163-3938265-00). A 62-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular in 2021 (Lot number was not reported) at the age of 62-year-old as single dose and dose 2 via an unspecified route of administration in 2021 (Lot number was not reported) at the age of 62-year-old as single dose for COVID-19 Vaccination; risankizumab (SKYRIZI), via subcutaneous from an unspecified date, at unspecified dose for Moderate to severe chronic plaque psoriasis. The patient medical history and concomitant medications were not reported. The patient experienced vaccination site pain in Jan2021. It was reported that the patient with events of non-serious Covid positive and sore arm after Covid vaccine with risankizumab. There was no reported medical history. On an unknown date, the patient experienced Sore arm after Covid Vaccine. In Jan2021, the patient experienced Covid positive. In 2021, the Covid positive resolved. On an unknown date, Sore arm after Covid vaccine resolved. Covid-19 Vaccine was also considered suspect. In Jan2021, patient had covid positive and lost sense of taste and smell but that was it. In 2021, he took two doses of Pfizer vaccine. His arm was a little sore. They just heard that people that had covid could not get the vaccine because there were antibodies in their bone marrow. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On unknown, patient received 1st dose COVID-19 Vaccine manufactured by Pfizer. The action taken in response to the events for risankizumab was unknown. The outcome of the events was recovered on an unspecified date in 2021. The reporter's causality for the event of Covid positive with Skyrizi(RISANKIZUMAB) was a reasonable possibility. The reporter's causality for the event of Sore arm after Covid vaccine was not provided. The reporter's assessment of the causal relationship of the events with the suspect product BNT162B2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. Information about lot/batch number has been requested.; Sender's Comments: Whatever the efficacy of a product, lack of effect can occur and it is an expected finding. Based on the limited information currently available in this case, this occurrence cannot be excluded. Vaccination site pain is possibly related due to a plausible temporal relationship.

On the left side of the callers face down to his chest, pain and itching and burning and a rash. The caller went to the ER and the doctors gave benadryl and cream and said it was an allergic reaction. there is still a rash, and it is burning and painful.

2 months later I had two insect bites and the second day I had a severe case of hives (I have never had hives before). This lead to anaphylactic shock resulting in low blood pressure and passing out. EMTs administered saline/epinephrine/steroid. Currently Doing follow up for allergies. Stopped taking lisinopril.

Rash on torso (trunk); Chills; Very cold; Nauseated; This is a spontaneous report received from a contactable consumer, the patient. A 62-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: UNKNOWN) via an unspecified route of administration in the left arm on 16Mar2021 at 08:00 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not have allergic history.The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: UNKNOWN) via an unspecified route of administration in the left arm on 24Feb2021 at 09:00 as a single dose for COVID-19 immunisation Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, Concomitant medications included Trazodone 50mg (MANUFACTURER UNKNOWN) 2 tablets per day, Baby asprin (MANUFACTURER UNKNOWN), within 2 weeks of vaccination and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 16Mar2021, the patient experienced chills, cold and nauseated. On 17Mar2021, the patient experienced rash on torso (trunk). Patient stated that after getting the 2nd dose, that evening patient started getting the chills and was very cold and felt like he had the flu. Patient also felt nauseated but did not throw up and took some Tylenol which helped but he did not check his temperature. Patient stated this lasted nearly 48 hours. On day 2 after getting the 2nd vaccine patient began getting a rash on his torso (trunk). It was mainly on the front side of his body but also some on back. The rash was fairly solid and looked like a sun burn. This lasted nearly a week with itching starting at about day 4 lasting about a full week from getting the 2nd dose. Patient was not feeling very well until about day 4 when he started getting energy to do things. At a week after patient pretty much back to normal. The clinical outcome of the events chills, cold, nauseated and rash on torso (trunk) was resolved on an unknown date in Mar2021.Patient has not tested positive for COVID-19 since having the vaccination. Information about lot/batch number cannot be obtained. No further information is expected.

Hard swelling at site of injection; Vaccination site redness; This is a spontaneous report received from a contactable consumer, the patient. A 62-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: EN6204) via an unspecified route of administration in the left arm on 08Mar2021 at 14:00 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. The patient's medical history included allergy to sulfa drugs. The concomitant medications 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. It was reported that the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 20Mar2021, the patient had a 2X2 inch hard red swelling at site of injection (vaccination site swelling and vaccination site erythema), which had appeared about 12 days after first injection. It was reported that it was the first, ever such reaction to a vaccine, either delayed or immediate. The redness began to subside after a few days and there were no other symptoms. The events didn't 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 events. The clinical outcome of the events vaccination site swelling and vaccination site erythema was recovering at the time of this report. No follow-up attempts are needed. No further information is expected.

faint; Soreness at injection site; chills; lethargy; body aches; weakness; Hypotension; This is a spontaneous report from a contactable consumer (patient reported himself). A 62-year-old male patient received his second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EW0178), via an unspecified route of administration, administered in Arm Left on 31May2021 at 10:15 AM (at the age of 62-year-old), as a single for covid-19 immunisation. The patient medical history included Coronary artery disease, CABG (Coronary artery bypass) surgery and hypertension. The patient had no known allergies. The patient received an unspecified concomitant medication within two weeks of vaccination. The patient previously received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EW0179), via an unspecified route of administration, administered in Arm Left on 10May2021at 10:00 AM, as a single for covid-19 immunisation. 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 did not have covid prior vaccination. The patient was not tested for covid-19 Since the vaccination. On 01Jun2021 at 09:00 AM, the patient experienced faint, soreness at injection site, chills, lethargy, body aches, weakness, and hypotension. Hypotension was continued to till the date. The patient visited physician office for the events. The treatment received for the adverse events was none. The patient was not resolved from all the events at the time of this report. Information on Lot/Batch number was available. Additional information has been requested.

INJECTION SITE PAIN & REDNESS, ARM PAIN. TIREDNESS, HEADACHES, MUSCLE + JOINT PAIN. CHILLS, FEVOR, NAUSEA, VOMITING, FEELING OFF/UNWELL.

Started with rash around belly and spread so went to ER. They gave him steroid shot, Benadryl, and one other thing he could t remember. things got worse. Blood pressure got very low, dizzy, nurse couldn?t get a pulse ox reading, fingers turning blue. They thought he was having allergic reaction to shot. Gave him Epipen. He said things got better then

Shortness of breath; Body aches; Pain; Headache; Nausea; Muscle pain; injection site pain; fever; feeling unwell; swelling of throat; weakness.; This is a spontaneous report from a contactable consumer. A male patient of 62 years age received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE LOT number UNKNOWN) On 21Mar2021 16:30 via an unspecified route of administration, on the left arm as a single first dose (at the age of 62 years) for Covid-19 immunization. Patients medical history reports bronchitis, COPD, asthma and oral cancer from 8/01 and operation/recovery/radiation till 11/01. The patient reports allergy to penicillin, nuts. Prior to vaccination patient has was not diagnosed with COVID-19. Since vaccination patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received doxycycline(UNKNOWN MANUFACTURER), metronidazole(UNKNOWN MANUFACTURER), guaifenesin(UNKNOWN MANUFACTURER), aspirin(UNKNOWN MANUFACTURER) within 2 weeks of vaccination. On 22Mar2021 patient reports to have shortness of breath, body aches & pain, headache, nausea/threw-up, muscle pain, injection site pain, fever, feeling unwell, swelling of throat, weakness. The patient also reports to have a compromised immune system due to oral cancer. No treatment was taken as a result of the events shortness of breath, body aches & pain, headache, nausea/threw-up, muscle pain, injection site pain, fever, feeling unwell, swelling of throat, weakness. 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 shortness of breath, body aches & pain, headache, nausea/threw-up, muscle pain, injection site pain, fever, feeling unwell, swelling of throat, weakness was recovering. No follow-up attempts are possible; information about lot number cannot be obtained.

Spoke to patient on the phone on 7/20/21. Patient claims that day of shot, injection site became a red "bullseye" lump/mark. Over the next few weeks up until today, patient claims a rash has continued to spread over his body that is very itchy. Also claims that he is now more sensitive to the sun (vision impaired) & can't physically tolerate being in the heat like he could before the vaccine.

Violently Sick; Throwing up/ Violent vomiting to Biel for 6 hours straight; cannot drink fluids or foods for 12 hours plus.; Chills; Joint pain; barely able to move or walk; Fever/Fevor 101; barely able to move or walk; Muscle pain; Nausea; Feeling unwell; Injection site pain; Tiredness; arm pain; Headache; injection site redness; injection site redness & swelling; He has minor discomfort; Diarrhea; This is a spontaneous report from a contactable consumer (patient). A 62-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: EW0180), via an unspecified route of administration, administered in arm left on 02Jul2021 at 10:30 AM (at the age of 62-year-old) as dose 2, single for COVID-19 immunization. Medical history included valtrex for infection in right eye, known allergies: mold, mildew, blue grass, dust, mites, cockroaches (start - 10 to 15 years). The patient concomitant medication included valaciclovir hydrochloride (VALTREX), allergy shots taken for allergy (patient stated it changes based on vials). Patient did not receive any other vaccine within 4 weeks prior vaccinations. Patient was not diagnosed with COVID prior vaccination. Patient was not tested COVID post vaccination. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: EN6200), via an unspecified route of administration, administered in arm right on 02Jul2021 at 05:45 PM (at the age of 62-year-old) as dose 1, single for COVID-19 immunization. The patient experienced he has minor discomfort, diarrhea on an unspecified date in 2021; injection site pain (the date patient received the vaccine), tiredness, arm pain, feeling unwell (subsided from feeling violently sick yesterday), headache, injection site redness, injection site redness & swelling on 02Jul2021; nausea on 04Jul2021; violently sick (It started at 5am (67 to 68 hours after vaccination). It has mostly subsided, gone away. Patient stated he has recovered with lasting effects because he was so beat up from throwing up) on 05Jul2021 at 05:00 AM, throwing up/ violent vomiting to biel for 6 hours straight (at 5 or 6 am yesterday. It lasted around 6 hours until noon), cannot drink fluids or foods for 12 hours plus, chills (around 5 or 6 am), joint pain (5 to 6 am), barely able to move or walk, fever/fever 101 (5 to 6 am, patient temperatures are normal now), muscle pain (around 5 or 6 am) on 05Jul2021. Adverse events did not result in emergency room, physician office visit. Adverse event: 12 of the 17 listed side effects on fact sheet revised 10May2021. injection site redness and swelling, arm pain. Feeling unwell, off. Joint and muscle pain, barely able to move or walk. Chills & Fevor 101. Violent vomiting to bile for 6 hours straight. cannot drink fluids or foods for 12 hours plus. Patient is calling about the vaccine, stated covid 19. He got the vaccine, his second shot and had a reaction that is on the paperwork. The patient underwent lab tests and procedures which included fever was 101 on 05Jul2021. The patient received tylenol, advil and pepto-bismol as treatment medication for the events joint pain, nausea, headache, fever/fever 101, muscle pain. Outcome of the events violently sick, feeling unwell, he has minor discomfort, diarrhea was unknown; tiredness, arm pain, cannot drink fluids or foods for 12 hours plus, joint pain, headache, injection site redness, muscle pain was recovering; injection site pain, throwing up/ violent vomiting to bile for 6 hours straight was recovered on 05Jul2021; chills, barely able to move or walk, nausea, injection site redness & swelling, fever/fever 101 was recovered on 06Jul2021. Follow-up (PRD/SRD 08Jul2021): Follow-up attempts are completed. No further information is expected.

itchy rash; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old male patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 28Mar2021 at 15:15 (at the age of 62-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient did not receive any vaccination in four weeks. The patient did not receive any other medications in two weeks. The patient did not have any allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 29Mar2021, the patient experienced broken out in an itchy rash since getting the vaccine. The rash was found on part of the face, part of the arm and around hip girdle. The event resulted in doctor or other healthcare professional office/clinic visit. It was unknown if the patient received treatment for the event. The clinical outcome of the event broken out in an itchy rash was not resolved at the time of report. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Since the vaccine: nerve issues including tingling and pain, heart palpitation/racing heart beat, burning in arms and shoulders, anxiety, depression, weakness, dizziness, itchy skin, sun sensitivity, heat sensitivity, brain fog, exhaustion/fatigue, tremors, tight chest

Rash on left side of body; Extreme tiredness; Head aches; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the right arm on 27Apr2021 at 09:45 (at the age of 62-years-old), as a single dose for COVID-19 immunisation. Medical history included high blood pressure and diabetes. The patient did not receive any concomitant medications. The patient previously received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the left arm on 07Apr2021 at 09:45 (at the age of 62-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 4 weeks prior to the COVID vaccine. On 28Apr2021 at 10:00, the patient experienced rash on left side of body, extreme tiredness and headaches. The events resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the events rash on left side of body, extreme tiredness and headaches was not recovered at the time of this report. No follow-up attempts are needed. No further information is expected.

I started having CCU - Cold Contact Urticaria on 4/26 or at least thats when I was exposed to cold and noticed hives; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration in the arm left on 13Apr2021 at 00:00 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. The patient's medical history was reported as none. Concomitant medication included liprosine (MANUFACTURER UNKNOWN). The patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration in the left arm left on 23Mar2021 at 00:00 (at the age of 62-years-old) 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 26Apr2021 at 00:00, the patient experienced CCU - Cold Contact Urticaria on 4/26 or at least that's when he was exposed to cold and noticed hives. The event resulted in doctor or other healthcare professional office/clinic visit. It was unknown whether the patient had received any treatment for the event. The clinical outcome of the event urticaria was not recovered at the time of this report. No follow-up attempts are needed. No further information is expected.

Pinched nerve in neck, knee cap was blown out, pinch nerve in lower back, pinched nerve in neck again causing a shoulder injury. Inflammation of the joints was diagnosed by chiropractor.

I had a very small, left sided C5 dermatome breakout of a rash that appeared to be herpes zoster (shingles). I?ve never had a rash like this before. It?s now been 2+ weeks and is fading, leaving me with mild burning and itching in same area. I went ahead and had 2cd dose on 1/7/21. FYI: I?m an Emergency Physician myself.

Only slight soreness at injection site first day. I was physically working hard out of town with limited sleep for next three days. I began experiencing significant body aches and pains, sneezing and minor congestion. However, activity involved substantial dust as I was sanding a floor. Saturday, January 2, I began having more extensive cold symptoms, coughing and runny nose with continued body aches and pains. I scheduled a covid test on Monday, January 4, scheduled for Wed. January 6th. I received positive results on Friday. January 8. On Saturday, January 8, I began developing increased light headedness and self monitored my blood pressure. It was at 191/107 when I went to Hospital to have it checked. I was released that afternoon.

He has irritation on his arms.; he got the first shot of the covid vaccine he started itching; This is a spontaneous report from a contactable consumer (patient). A 63-years-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in left upper arm on 31Dec2020 at single dose for COVID-19 immunisation, dexlansoprazole (DEXILANT) oral from 2019 (reported as 2 years ago as of 06Jan2021) to an unspecified date at 30 mg capsule once as needed for acid reflux, oxycodone oral from 2020 (reported as 3-4 months ago as of 06Jan2021) to an unspecified date at 10mg tablet once by mouth as needed for chronic pain from two back surgeries that did not go well, omeprazole oral from 2020 (reported as about a year ago as of 06Jan2021) to an unspecified date at 20 mg capsule once by mouth as needed for acid reflux. Medical history included ongoing low white blood cells has had for a couple of years, and two back surgeries. There were no concomitant medications. The patient previously received Flu shots. The patient took his first dose of the COVID Vaccine last Thursday (31Dec2020) and about 10 minutes after he started itching. That day he had previously taken a PPI medication for acid reflux, Dexilant, and some pain medication, Oxycodone. Since then he has been trying to rule out what is going on and what gave him the itching. Now, every time he takes his PPI medication, either Dexilant, or Omeprazole, he itches. This did not happen prior to getting the vaccine. He asks, how long does the COVID Vaccine stay in the system for? He is supposed to get the second dose in 3 weeks, but he does not want the same results. He was asking if it is normal for his to experiencing itching and how long will it occur. He has to take his medications. He does not want issues with his esophagus, but he also does not want to itch. The itching right after he got the vaccine lasted about a day or so and dissipated by Friday. Saturday he did not have it. Then he took a Dexilant that day, on Saturday, for acid reflux, and he itched until the Dexilant was out of his system. Then yesterday, he tried an Omeprazole and he had the same results. He can not even wear a pajama top or anything on his arms cause it makes him itch. He has irritation on his arms on Jan2021. He also has low white blood cells, which he had prior to getting the vaccine. He started Dexilant originally about 2 years ago. He takes it only when he needs it. Has taken it about 3-4 times prior to getting the COVID Vaccine. He started Omeprazole about a year ago. Only takes this as needed, PRN, even thought the doctor said he should not take it as needed. He does not like to take medicine so he tries not to take things. He has taken flu shots in the past, he gets one every year, and has never had an issue with that. He wants to get the second dose of the vaccine, he just does not want to itch. The action taken in response to the event for dexlansoprazole, oxycodone, omeprazole was unknown. Event outcome of itching was recovered on Jan2020, while for other event(s) was unknown. Information about lot/batch number has been requested.

About an hour later, slight headache. Around 2am on 1/12, woke up with hip joint pain. On 1/13 slight injection site pain and continued hip pain, and around 11am had slight nausea that went away. 1/14 still have hip pain.

Progressive symptoms of mild itchyness of skin all over body on first day to painful pin and needles sensation with continued itching over entire body only occuring at night by day 7 . Symptoms are temporarily relieved with zyrtec and famotidine. Symptoms are ongoing and getting progressively worse each night. No rashes are observed so far. Headache and severe dizziness with nausea were experienced on day 4 but only lasting 4 hrs.

Severe join Pain/ all over/ groin pain/ muscle pain/ night cramps/headaches/ injection pain/ feel unwell/ like sinus infection/ fatigue/ fall asleep midday. 3 weeks later. Still have some body pain/ still fatigued/ unwell and headache. Dizzy sometimes. Not my normal/ alert athletic self. Haven?t felt like exercising since took shot.

LOW GRADE FEVER, JOINT AND MUSCLE ACHES, PAIN AT INJECTION SITE, SLEEPINESS FROM LATE EVENING ON 01/07 TO EVENING OF 01/08. ABOUT 22 HRS TOTAL. TOOK EXTRA TYLENOL. ONE PILL TAKEN TWICE DURING REACTION TIME.

rash; developed symptoms of covid on 27Dec / on 30Dec2020 he tested positive for the virus / cough; developed symptoms of covid on 27Dec / on 30Dec2020 he tested positive for the virus / cough; This is a spontaneous report from a contactable consumer (patient). A 63-year-old male patient received the 1st does of bnt162b2 (BNT162B2) at single dose left upper arm on 23Dec2020 for Covid-19 immunisation, administered at hospital. Medical history included ongoing hypertension that began maybe 10 years before and still ongoing, controlled with medication. No family medical history relevant to the events. The concomitant medications included paracetamol (TYLENOL). History of all previous immunization with the Pfizer vaccine considered as suspect was none. No additional vaccines administered on same date of the suspect. The patient had not received any other vaccines within 4 weeks prior to the BNT162B2 vaccine. He has not had reactions to any other vaccines. On 30Dec2020 he tested positive for Covid. His symptoms of covid started 27Dec2020 in the evening sometime probably around 7pm. He experienced cough in Dec2020. No visit to physician office was required. On the 06Jan2021 he went to the emergency room but that was because he was concerned about rash he developed. He thought it was due to the Tylenol he was taking. Relevant tests performed in Ja2021 included: blood work and chest X-ray did when he went in for the rash and they were was fine. He was treated with steroid injection for the rash. The rash cleared up in the next couple days. As of 12Jan2021 the only thing he has cough but he coughs anyway. He still had a cough but it was not atypical for him to have a cough. He was scheduled to receive his second dose on 13Jan2021. He no longer had any Covid symptoms and wanted to know if he could still get the second dose as scheduled. The outcome of event tested positive for the virus and not recovered was unknown, of coughs was not recovered. A Product Complaint was filed. Information on lot/batch number has been requested.

Severe shoulder ache followed by muscle tightness in neck, lasting several hours. On subsequent days muscle pain continued sporadically in neck, mid-back , and chest. Hot/ fLushed feeling accompanied back and chest pain but no elevated temperature was observed. On day 5 the left shoulder pain returned with a vengeance for about 4 hours, centered at the injection site.

The second dose of Covid Vaccine knocked me out completely : headache, fever ,chills and pain at the injection site . Duration of effects: 48 hours

I received a red rash that was on both of my arms three spots: wrist, forearm and armpit area and the base of my neck. It does not itch or bother me.

Shortness of breath started 1/16 in the AM, worse when lying down. .Also had diarrhea and a rash on right lower extremity. Discharged from ED to home. No significant findings found on work up.

One week after the vaccine his left great toe and foot became red, warm and swollen. He had difficulty walking for several days and is still experiencing swelling. He has been using ice, elevation and Motrin.

soreness in left arm; feeling kind of achy; was wanting to run a fever/Very high fever in excess of 102 degrees Fahrenheit; This is a spontaneous report from a contactable consumer (patient). A 63-year-old male patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EJ1686) via an unspecified route of administration on 04Jan2021 at a single dose on the left arm for vaccination. Medical history included ongoing hypothyroidism. Concomitant medication include levothyroxine (manufacturer unknown) from an unspecified date probably 2-3 years ago and ongoing for hypothyroidism. The patient reported that the first dose was administered of the Pfizer COVID-19 Vaccine on 04Jan2021. He had onset of soreness in left arm that day, 14Jan2021 which he recovered completely from by 05Jan2021. He stated that starting maybe 05Jan2021 or 06Jan2021, he had onset of feeling kind of achy and like he was wanting to run a fever. Starting 08Jan2021, he started running a very high fever in excess of 102 degrees Fahrenheit which has been ongoing and persistent since then. He has been taking Tylenol every 6 hours to try to control the high fever but the high fever is just not going away. He was wondering if there is anything he can do because his primary care physician (PCP) can't really help him at the clinic; He was wondering if Pfizer is familiar with this reaction and if there are any recommendations regarding them. He has taken Tylenol to help, but it is not making it go away. He wanted to know if steroids could be used to counteract this side effect. He added that he is supposed to get the second dose 25Jan2021 but he does not plan to get the second dose, at this point he does not want to do that. He was administered the vaccine because his mother lives in an assisted living facility where the vaccine was offered to residents; and because he acts as a sitter at the facility it was offered to him. On 11Jan2021 he went to Urgent Care for these events, and was given a Rapid COVID-19 Test which had negative result. The outcome of the event soreness in left arm was recovered on 05Jan2021, the outcome of the event was wanting to run a fever/very high fever in excess of 102 degrees fahrenheit was not recovered and the outcome of the event feeling kind of achy was unknown.

Fever, soreness at site of vaccine and headache were only present early on and resolved in 48 hours of the vaccine. Then after a few days, these symptoms started (below): PAIN in every joint, large and small, including vertebral spine, shoulders, hips, knees, elbows, hands and feet, fingers and toes, as well as costochondral joints in the ribs; SWELLING and REDNESS in many joints including most of right foot, some of left foot, knees, hips and sacroiliac joints. On and off headache. Slight reduction, but still present after 3 weeks.

pt states he started feeling pain in the left arm about one hour after the vax. He had a little back pain that night but could not get out of bed the next morning. He said it feels like the pain is all over his lower back and in the kidneys. Pt will contact his PCP.

Itching behind knee caps, both legs, ribs under armpits, whole back itching and redness all over body and got really bad itchy when he got home but it went away after a few hours with no treatment.

This was my first COVID-19 vaccine. Second is scheduled for 2 March. Soreness developed at point of injection that evening, but not unusual. I felt pressure in head/neck area and had dry cough that evening. Took Advil PM before going to bed. About 2am that night I started having severe chills. I took temp at 5am and it was 101.7. Took Tylenol and temp went to 99.8 by 7 am. Temp went back up to 101.5 by noon. Had called my workplace medical and they want me to stay out for 3 days due to the reaction.

It felt like there was water in the ear; The right cheek was swollen; lymph nodes were swollen; He felt a pressure in the right ear; It impaired his hearing due to the pressure/trouble hearing; The face felt achy with hives; The face felt achy with hives; This is a spontaneous report from a contactable pharmacist (patient's wife). A 63-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot:EL9262), via an unspecified route of administration injection in the left upper arm on at a single dose on 21Jan2021,10:00 for covid-19 immunization. Relevant medical history included blood pressure (unspecified), diabetes, stomach acidity, lipid lowering all from an unknown date and unknown if ongoing. Ongoing concomitant medications included irbesartan blood pressure, metformin for diabetes, famotidine for stomach acidity, atorvastatin for lipid lowering colecalciferol (vitamin D) for unknown indication. The patient experienced lymph nodes were swollen, felt a pressure in the right ear, felt like there was water in the ear, right cheek was swollen on 21Jan2021 17:00; impaired hearing due to the pressure/trouble hearing, face felt achy with hives on 21Jan2021. The events were mild, thought it would go away by itself. The events did not require a visit to emergency room and physician's office. It was further reported that around 5-6 hours after getting the vaccine, in the evening, he started to have the lymph nodes on the right side of his face swelling. Along with that he had trouble hearing. It was like swimming and lots of water got in the ear and that water could not come out. He also had hives. He had hives under his eye. It was like on his cheek between his eye. It was red and about the size if a finger nail. She would like to speak to someone about him taking the second dose. She wanted to know if there was any concern in him getting the second dose. The issues with trouble hearing is getting better, he is almost back to normal. When he touches his ear it still feels sensitive. The hives is still there, but it is like paler, but still there. It is like weaker at this point . Outcome of the event lymph nodes were swollen, impaired hearing due to the pressure/trouble hearing, face felt achy with hives was recovering, while unknown outcome for the event pressure in the right ear, felt like there was water in the ear, right cheek was swollen was unknown.

Day three mild swollen tongue that lasted 5 hours, day five mild swollen upper right lip that lasted 5 hours, day six moderate swollen left face/cheek that lasted 24 hours, day seven swollen left hand/wrist that was extremely itchy that lasted 24 hours and counting.

Light headedness, 100° temperature, lethargic, pain at injection site, tight muscles across shoulders & neck

Leg pain and bruising; Leg pain and bruising/bruising above both kneecaps and down his legs; Muscle aches; Feet are a little colder than normal; he still aches; This is a spontaneous report from a contactable consumer (patient). A 63-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported), via an unspecified route of administration at the right arm on 13Jan2021 09:00 at single dose for COVID-19 immunization. Medical history included taking blood pressure medicine, medicine for uric acid, stated he takes three medications but did not provide product names. The patient had the first COVID shot on 23Dec2020 at 20:30 at the right arm at the age of 63-year-old and clarified he had no problems after first vaccination. The patient experienced leg pain and bruising which started immediately day after second COVID shot on 14Jan2021. Noticed bruising above both kneecaps and down his legs, which felt like pretty severe flu pain. After a period of time, it didn't' feel right. He didn't see anything like that listed as side effects. Has gotten a little better but was still there. Takes Ibuprofen and it helps a little with the leg pain and bruising. Feet are a little colder than normal and he still aches, also had muscle aches on 14Jan2021 which he never had before. The outcome of the event leg pain and bruising was recovering and unknown for the rest of the events. Information on lot number/batch number has been requested.

Approximately 32 hours after vaccination a rash (purpura) with Urticaria appeared on upper side of left forearm to wrist. Took Benadryl, used Hydrocortisone cream and Calamine lotion. At the time of this report (5th day after vaccine) the rise and itch have substantially subsided for the 1st time. The purpura is starting to burst and leak clear fluid. Estimate 50% improvement from 12 hours ago.

Broke out with hives in the middle of the night 8 days after the injection. Thigh area. Took Benadryl and it was gone in a few hours. Happened second and third night as well....but not as many hives each night

About 13 hours after getting 1st dose of pfizer covid vaccine the patient developed hives like rash on arms and legs. Rash still present, persistent, and worse 6 days later when he was seen in our office. No swelling or respiratory symptoms. Pt advised to take antihistamine and h2 blocker. Pt was referred to an allergist.

After injection, immediately had localized swelling at the site of injection (right deltoid) No complaints of pain, SOA. Ice pack applied. Monitored for 30 min, no complaints at the time of discharge. Left voice mail for him to contact his PCP for 2nd shot recommendations.

Bad itchy rash and severe indigestion. Cardiac surgeon recommended 40 mg Pepcid AC. This reduced the acid build up and I was left with the rash

48 hours after first dose - extreme chills, joint and muscle aches, rash on legs. Felt like symptoms of Covid. (I have never had Covid)

First: Site swelling & pain (about a week - 03/04 to about 03/10/21) Second: Headache, muscle pain, joint pain, tired (started day after - 03/05 to 03/06/21 - about 1-2 days) Third: Serious pain in left arm (mid-upper arm & lower arm down to the hand). Bones hurt, muscles hurt, and joints hurt. Rash on upper and lower left arm. Sensitive to touch and slightly red. Serious diarrhea just after arm started to hurt. (started 03/17/21). Still on-going.

Narrative: 62 yo male who presented to the ED 15 days after receiving 2nd COVID vaccine with complaints of rash to bilateral arms, groin and trunk for x1 week. Pt denied any new detergents, soaps or contact with the environment. There was no oral swelling, SOB, or wheezing upon evaluation. Patient reported that he had taken Benadryl with no relief. He denied prior allergic reactions. No fever, chills, headache, neck pain, chest or abdominal pain, N/V/D or GI or GU complaints upon evaluation. Patient was discharged with Benadryl, pepcid, prednisone and an epi-pen. He was instructed to keep a diary of all food intake, creams, detergets etc inorder to track the cause of the allergic reaction. ED provider assessed that mild allergic reaction should not become serious as it had been already going on for 1 week without progression, albeit comfortable symptoms.

10 minutes after received shot, left arm went numb, then both arms turned blood red. Two hours later had H/A, fever, chills, increased heart rate, 102.8, nauseous, caused UTI. Wife had to help him get into the car due to feeling of illness. No shortness of breath or difficulty breathing

with in 12 hours of the vaccine in the right deltoid, Herpes Zoster (shingles) outbreak t-1/T-2 right dermatome. rash blistering upper anterior chest wall and posterior aspect of upper right back down the right arm (posterior) patient notes he has never gotten his Shingrix vaccine

About 10 minutes after receiving vaccine the patient developed tightness in his throat,anxiety,redness in face and hands and shortness of breath.The patient was given epinephrine 0.3 mg intramuscularly in his left lateral thigh at 11:10 am.The patient responded nicely to the epinephrine and vs at 11:20 were bp 138/68,pulse 102,pulse oximeter 95%.His treatment occurred at the vaccination site. He then was transferred to our local emergency room and was observed for 2 hours.His symptoms abated and he was discharged. He informed us that he had received a moderna vaccine on 01/28/2021 without complications.We learned this after his vaccination.

Passing dizziness at time of inoculation - not reported Painful palpable enlarged gland under left jaw All over body rash - extreme discomfort from itching

lightheaded Vital Signs: B/P: 136-90 HR: 82 Resp: 22 O2Sat:99 Skin Signs: Warn and Dry Circulation: Cap Refill <2 sec Treatment: Lightheaded improving as we speak. Did same with flu shot 4 yrs ago. Stayed an extra 10 mins for observation. Repeat Assessment @ 13:15 Vitals: B/P: 128/88 HR: 78 O2Sat: 94 Discharged self.

Body rash, redness, itching , and peeling Treatment- Steroid creams, Allergy medications, -Outcome to be determined

Injection site pain, fatigue, headache, chills, nausea, upset stomach, feeling unwell, inability to eat Took 2 Tylenol

Site: Pain at Injection Site-Severe, Systemic: Joint Pain-Severe, Additional Details: Patient came to our pharmacy to pick up prescriptions for Diclofenac 50 mg and Norco 5/325, and informed me that ever since he received his Covid vaccine, his right shoulder has been in pain to the point that he could no longer sleep at night. I have called Store 4742 and informed the pharmacist on duty about this report from the patient the same afternoon.

Received vaccination on Saturday night, 3/13/2021. On Tuesday developed headache, fever( highest recorded was 101.2), chills and body aches, with most sever pain left side mid-back. Treated with Tylenol and it lasted about two days. On Friday developed a rash on my right foot, that by Sunday had spread to the other foot, both hands and arms, and around my waist and partially down my legs. Bright red and itchy. Still have splotchy rash two weeks later. Due to get my second shot tomorrow, Saturday, April 3rd.

he just feels bad; white blood cell count is high; both him and his wife have body aches; flare up of an infection in his scrotum; I am crippled and I had not it before; I am sick; he has a rash on his scrotum; I am crippled and I had not it before; I am sick; This is a spontaneous report from a contactable consumer (patient). A 63-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: Not Reported), via an unspecified route of administration on Arm Right on 18Mar2021 at single dose for COVID-19 immunisation. Medical history included spinal injury, an infection in his scrotum, some neurogenic things, white blood cells (his white blood cells and scrotum started prior to him getting the vaccine). There were no concomitant medications. It was reported that, the consumer stated, "my wife and me went to hospital and we got a COVID vaccine first one, we had some, my wife had terrible side effects, I am crippled, and I had not it before in Mar2021, she is ok, but she is just sick, I am sick, but she is very sick and she got bad stuffs (rash)." Caller states that both him and his wife were having some side effects, although his wife was having the worse trouble. Caller states that last night, him and his wife were up all night. Caller was up because his wife was up so sick. Caller states that both him and his wife are sick and disabled, that is why they got the shot. Caller reports that he is retired and disabled because he got hurt at work. Caller states that what he is experiencing, is he just feels bad on 18Mar2021. Caller states that he did previously go to a doctor to do a blood study, the doctor is looking for blood diseases or cancer in the caller, and caller thinks that taking the COVID shot just exposed his weak spots. Caller reports that both him and his wife have body aches. Caller was wondering if there was anything, he can go get over the counter at the pharmacy to help. Caller reports that he cannot call his doctor, because they are all out on Fridays. Caller states that him and his wife are not planning to take the second dose of the product. Caller states that they have a lot of hurricanes where they live. Their house got tore up in one, and they sold it to one of their sons, and the caller and his wife moved out to their beach house for a while. He had an infection in his scrotum, something stung him, and that is what the doctors are looking for in him now, because his white blood cell count is high, and he has a rash on his scrotum in Mar2021. It was infected. Caller states that this infection in his scrotum has flared back up since getting the COVID vaccine yesterday, so caller had thought it went away but he guesses it never went away. Caller confirms that the issues with his white blood cells and scrotum started prior to him getting the vaccine, but the caller thinks that the vaccine was exposing the caller's weak spots, and maybe that is a god send because it is all flared up now, and the caller will be able to tell his doctor that. Caller states that he has been getting high white blood cell count readings since the stuff with his scrotum first started, and that is why his doctor sent him to an Oncologist for all this blood testing, so maybe this will be a b lessing in disguise for the caller, in finding out what is wrong with him. The outcome of the events was reported as unknown. Information about lot/batch number has been requested.

On the right hand between the thumb and the index finger there were itchy bumps under the skin/Subsequently more of the itchy bumps on torso, arm, back, neck and the rash kept building up; Lips were swollen; Right nipple was irritated and the skin around it dried up; This is a spontaneous report from a non-contactable consumer. A 63-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered on left arm on 27Feb2021 16:00 (Batch/Lot number was not reported) at single dose (at the age of 63 years old) for COVID-19 immunisation. Medical history included hypertension, hyperlipidaemia, retinal tears and known allergies: Penicillin. Concomitant medications included ascorbic acid, betacarotene, cupric oxide, manganese sulfate, selenium, tocopheryl acetate, ubidecarenone, zinc oxide (COQ10 [ASCORBIC ACID;BETACAROTENE;CUPRIC OXIDE;MANGANESE SULFATE;SELENIUM;TOCOPHERYL ACETATE;UBIDECARENONE;ZINC OXIDE]), colecalciferol (VITAMIN D [COLECALCIFEROL]), acetylsalicylic acid (BABY ASPIRIN), all taken for an unspecified indication. The patient previously took NIASPAN and experienced known allergies. At 19:30 pm on the day of the vaccination, on the right hand between the thumb and the index finger there were itchy bumps under the skin. Patient assumed it was insect bite. Subsequently more of the itchy bumps on torso, arm, back, neck and the rash kept building up. Patient started taking OTC Benadryl and Claritin on 4-5 days after consultation with PCP. However, reaction continued and the lips were swollen as well. Patient was prescribed steroids 4mg tapering blister pack by a separate physician since the rash had progressed to the chest. Right nipple was irritated and the skin around it dried up. Patient went to a dermatologist on 10Mar2020 and got a biopsy. Condition has not improved. The patient underwent blood test on Mar2021 for COVID and the result was negative. AE resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The outcome of the events were not recovered. Information on the lot/batch number has been requested.

Head ache, irritated sinuses, fatigue, sore muscles, pain at injection site, for 3 days. Treated with acetaminophen on 3rd day.

Immediate swelling at injection site (~0.75" high). 30 hours later experienced extreme shortness of breath with rapid onset wich lasted for 3 hours. Next 3 days extremely tired to the point of barely being able to get out of bed. Following 4 days, very short of breath after climbing one story of household steps. Currently, very low endurance before running out of breath.

1. Peripheral neuropathy in arms and legs, no treatment, perceived same day as getting the vaccine, symptoms continue. 2. Arthritis in neck, shoulders and hips, no treatment other than ibuprofen , perceived same day as getting vaccine, symptoms continue. 3. Metallic taste on tongue and tingling of tongue, no treatment, perceived same day as getting vaccine, symptoms seemed to have subsided. 4. Stomach muscle fatigue, no treatment, perceived same day as getting vaccine, symptoms including burning sensation continue. 5. Itchy head, no treatment, perceived same day as getting vaccine, symptoms have lessened over time. 6. Stuffy head - unable to clear ears, no treatment, perceived same day as getting vaccine, symptoms have lessened over time. 7. Generalized sore muscles, no treatment, perceived on same day as getting vaccine, symptoms continue. 8. Generalized aching joints, no treatment, perceived on same day as getting vaccine, symptoms continue. 9. Enlarged or swollen lymph nodes, no treatment, perceived a few days after getting vaccine, symptoms have lessened over time. 10. Testicular pain, ice pack as needed, perceived a few days after getting vaccine, symptoms continue.

Rash covering the majority of my face when I woke up the next day. No hives and did not itch. Red patches and blotches. Not really bothersome. Got a little better every day until it was hard to see any a week later. Momentary dizziness, also the next day, like a three second flash, when rising from laying flat, laying flat from standing or sitting, or rolling over while laying down. Passes and I can sleep and not notice it unless I am awake enough, and cognizant enough, to notice it when I roll over. Once standing and moving about there is no problem except a feeling, I have seen described as brain fog, of being a little off mentally. Not sharp, but no dizziness. Can maintain normal activity that includes bending over, kneeling down, driving and riding in a car without any dizziness. Have tried eply maneuver, something I can do, but have not had any improvement. Brain fog seems to improve with normal daily movement and I have been trying to avoid my normal caffeine intake.

I am current diabetic and have a recent history (1 year ago) of muscular dystrophy. I use a cane to assist with mobility, and cannot lift my legs far to go up high stairs, nor lift my arms past my chest as a baseline. Later in the evening/middle of the night, after the second shot, I got up around 3:30am to use the rest room and after each step, my knees, legs, hips, and arms gave out, falling forward on my face and head. I had no strength to catch myself from falling, nor could I lift myself at all. Initially, I could not even roll over. It took 10 minutes with help from my wife to roll over, but I remained on the floor. I was on the bathroom floor/snake crawling for 2 hours trying to figure out ways I can get up, but I had no strength at all. After snake crawling to the bedroom, my wife called the paramedics to get me up at 530am, Tuesday April 6th. Later that night of the 6th I did a little better, with help I could sit up in the bed. Overnight I tried to lift up to stand, and barely could stand, but my legs were too shaky, body bruised of course, and weak. April 7th, the next day, I was able to sit up. Later that day I was able to get up to go to the bathroom with my wife?s help and the use of a rolling walker with wheels, brakes and a seat, about 3:50am this morning. I have 35-40% of my strength, and can sit on the side of the bed. I need assistance to the bathroom and I have a ways to go to recover to my baseline.

Soreness at the location of shot, fever, chills accompanied by shaking, bad headache, body aches, general weakness and fatigue. Began about 11 hrs after vaccine was administered.

Patient with subjective itching without visible hives. Zyrtec 10mg PO was given. With serial monitoring, the patient returned to baseline. He was discharged home as his own driver, no drowsiness noted.

Pt came to the ER via ambulance with SOB, difficulty breathing, confusion and combativeness which had gotten worse over the day 4/3/21. He had a rash all over his body.. After the respiratory treatments failed, pt was intubated and transferred to a higher level of care and expired on 4/4/21

The day after vaccination a large lump (orange-sized hematoma) appeared on my lower left leg. Painful when touched. About 3 days later a second lump appeared 2 inches below the first. Area between the two lumps painful. I applied ice and wrapped for another week. After two weeks the second lump was almost gone. First had decreased in size. I went to my physician 2 weeks after the day of the shot.

Increasing 'discomfort' at injection site, headache starting yesterday. Currently running a 101 temp.

Pfizer-BioNTech COVID-19 Vaccine EUA 1. Pain at the injection site - 2 days 2. Tiredness - 2 days The severity level decreased the third day after the second dose.

20 minutes after injection shoulder area started to become number at the injection site. 35 minutes after the injection my neck and face started to become numb. As the numbness traveled from the injection site (left to right) across my neck and face, the numb areas became a "tingling" feeling on face, lips, chin and below the eye. Again traveling from left to right (the injection was in the left arm). Day two the above symptoms have lessened but have not gone away. Starting the same evening of the injection I experienced a progressively worse headache. As of 4/13/2021 I still have some numbness and tingling on the left side of my lower face between my cheek and chin. Headache is going away slowly.

I received the shot around 9am, That evening my left arm was a bit sore as well as my neck muscles. The next day I had several of my old Shingles symptoms return, weird feeling in my left eye, itchy eyebrow muscle, itchy skin on left side. (I had the shingles about 15 years ago, LEFT side, not too bad, mostly itchy, with recurring odd things just mentioned maybe once a year) The the 2nd day I got a weird tingling, buzzing feeling in my left upper back above shoulder blade, like those TENS device electric muscle stimulators. This is similar to my shingles twitches, but different and NEW. Maybe I should have taken the shot in my right arm? I may take the second shot in my right arm.

Breaking out on neck and bald head, pt reports he put hydrocortisone and then later on noticed a saw rash on legs. Pt states his doctor is not open today so I advised he follow up with urgent care.

I developed a hive type rash in several areas of my body. It seemed bilateral, large red areas with welt like bumps. Places included my neck...front and back, front of my chest near my armpits, under my armpits, both sides all over my ribs, my waistband my groin area , several areas of my back, by buttocks, the back of my legs, and the back of my knees. The rash wa extremely itchy and cortisone cream did not help. It kept me up most of the night. It went away in the morning but started up again at about 5pm the next day. That second day was worse covering more areas of my body

Severe vertigo, moderate nausea, minor soreness at injection site the next morning. By 2 pm, down to minor vertigo and moderate headache.

Extreme fatigue initially and high body temperature. All on the same day. Sore arm at injection start.

Approx time frames: 3/10-3/17- soreness and lesions on toes, both feet 3/15-4/1- Purple flushing of toes, numbness, pins and needles 3/20-4/20- Extreme coldness of feet., so much so that it was waking me up at night. 3/22- podiatrist visit- diagnosis chilblains. Prescribed nitro-gel and 325mg aspirin 1x/day for one month took nitro-gel one night- very bad headache, continued aspirin 3/25- took warm bath, felt turbulence in blood vessels of ankle area, toes flushing purple and white. Seemed to improve condition somewhat. 3/29- Second Pfizer 4/4- 4/15- hives and itching all over body 4/12- 4/20 Edema on feet and ankles

allergic reaction; body rash; Blood pressure has gone up; Ears ring a little bit; This is a spontaneous report received from a contactable consumer (patient). A 63-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot number: EP4534) via an intramuscular route of administration in left arm on 28Mar2021 at 10:15 AM (at the age of 63-year-old) as single dose for COVID-19 immunization. Patient medical history included diagnosed allergies, compromised immune status, respiratory illness, genetic / chromosomal abnormalities, endocrine abnormalities, diabetes and obesity. The patient 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 wasn't diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. On 28Mar2021 at 10:15 AM, the patient experienced body rash, blood pressure has gone up and ears ring a little bit, on an unspecified date patient experienced allergic reaction. The events were considered as a non-serious. Therapeutic measures were taken as a result of body rash and treatment included diphenhydramine hydrochloride (BENADRYL). The outcome of the event body rash was reported as not recovered and other events was reported as unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Could not stand; Piercing pain in middle of spine to tailbone; Piercing pain in middle of spine to tailbone; Walking was very difficult; Left arm injection site sore; This is a spontaneous report from a contactable consumer(spouse). A 63-year-old male patient received second dose BNT162B2 (Pfizer BioNTech Covid 19 vaccine, lot number ER8729), intramuscular at Arm Left on 06APR2021 10:45 at the 63 years old at single dose for COVID-19 immunization. The medical history was none. The concomitant medications were none. The Historical Vaccine was BNT162B2 first dose on 16MAR2021 at 63 years old for COVID-19 immunization (Lot ER2613; Injected in left arm given in the muscle).The reporter was calling on behalf of her husband who had the second vaccine yesterday. He had an odd reaction and was not good. He had to go to work after getting the vaccine and was at work for an hour. He could not stand and he is a chef. She had to go pick him up. There was a piercing pain in the middle of his spine to his tailbone. The patient experienced Walking was very difficult and Left arm injection site sore. He has been on the Tylenol which is the protocol. All of the events happened on 06APR2021 12:30. This morning on Day 2, it was not much better. She would like to know if there have been any reports of this and what Pfizer recommends for this. The outcome of the events was unknown. No follow-up attempts are needed. No further information is expected.

he experiences a lot of pain due to his bone cancer/been worse recently/pain has increased; more tired/tiredness; more headaches/headache; slight nausea/light nausea that is not very severe; feels very sick/not feeling well; muscle pain; joint pain; injection site swelling and redness; injection site swelling and redness; swollen lymph nodes; This is a spontaneous report from a contactable consumer (patient). A 63-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 25Mar2021 (at the age of 63 years old) (Batch/Lot number was not reported) as a single dose for COVID-19 immunisation. Medical history included ongoing bone cancer, ongoing pain from bone cancer, and nausea (has had nausea with the cancer). The patient's concomitant medications were not reported. The patient called about COVID-19 vaccine and mentioned that he received the 1st dose of COVID-19 vaccine on 25Mar2021 and experienced side effects not right away but shortly thereafter. He mentioned that he has bone cancer and he experience a lot of pain due to his bone cancer. He does not have an easy life as he experiences a lot of pain due to his bone cancer. He has a lot of pain to begin with because of the cancer that he has and now pain has been worse recently. He does not know if it just the progression of the pain or if it is coming from the injection. The patient confirmed that he experienced lists of side effects of more tired/tiredness, more headaches/headache, muscle pain, joint pain, injection site swelling and redness, slight nausea, feeling unwell, and swollen lymph nodes. He still feels very sick, is in a lot of pain, and not feeling well. He confirmed this list is from the paperwork he was given and adds that the only thing that he feels is light nausea that is not very severe. He added that he has had nausea with the cancer, so this nausea would be very light. But, he also he has a headache and tiredness. The patient added that his pain has increased, and the pain is the worst. The patient did not know how long it will take before feeling side effects from the vaccine or how that works. The patient asked if the side effects is same for everyone or if it is different for everybody. He added that reporting the event is not going to help in finding out where he is going with this. He stated he is at a crossroads, trying to determine if he needs to increase his pain medication since he now has more pain. He understands that Pfizer does not provide medical advice. He states that he was asking Pfizer to see if Pfizer has an understanding of when these side effects might show themselves or when they would and how severe they would come. His second vaccination is due on 15Apr2021. Outcome of the events was unknown. Information on the lot/batch number has been requested.

A large patch of redness at the injection site, getting larger, hot painful at times, I put ice on to ease the pain and swelling and redness, today I noticed just this afternoon my LEFT armpit my Lymph node is VERY LARGE and sore if you feel around it, Also last night I noticed my RIGHT lypmh node just under my RIGHT ear has popped out.

4-3-21- received my first covid 19 shot 4-10-21 went to have foot blister examined- they admitted me and started an IV of Vancomycin which sent me into anaphylaxis and this stopped my heart. I required cpr, defibrillator to get things going again. I was on life support for the better part of 4 days and then finally come back

help knock pain down for joints hurt like heck; a pinching like pins and needles trying to get out on your stomach area, it comes and goes; first time the rash itched underneath; Like a warm, hot forehead, gets warm and then gets hot like running a fever to the touch burning on forehead comes and goes; Like a warm, hot forehead, gets warm and then gets hot like running a fever to the touch burning on forehead comes and goes; Started freezing all over the place, hands are ice cold; Starts effecting different joints in the body, hit the muscle or joint; Starts effecting different joints in the body, hit the muscle or joint; Had a rash on right chest but it wasn't itching, it was just burning, strip of red rash going down left side of neck that went away and another rash started under left armpit; Had a rash on right chest but it wasn't itching, it was just burning, strip of red rash going down left side of neck that went away and another rash started under left armpit; Had a rash on right chest but it wasn't itching, it was just burning, strip of red rash going down left side of neck that went away and another rash started under left armpit; Started freezing all over the place, hands are ice cold; a little pain in the muscle; A paramedic gave vaccine and hit an artery; bleeding underneath skin above injection site, 7 droplets of blood above injection site; When stood up couldn't breath and throat was like closed off; When stood up couldn't breath and throat was like closed off; Severe sharp pain in your head that comes and goes each day to this day; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 63-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Batch/ Lot Number: EN6208 and expiry date not provided) via intravenous, in left arm in shoulder area on 18Mar2021 (at the age of 63-years-old) as a single dose for covid-19 immunisation at hospital. Appointment was for 8:40, told facility he had allergic reactions to allergies. Medical history included patient had life and death lung surgery in 1997, lost bottom lobe on lung, less breathing capacity than normal person. There was no relevant family medical history. Patient was told by family doctor, should get the Covid shot. Concomitant medications were none. Patient did not have prior vaccinations within 4 weeks. No additional vaccines were administered on same date of suspect vaccine. There was no investigation assessment. AE(s) following prior vaccinations: Patient stated it was not like this, usually just sore arm where put needle in, never had blood fly out of arm on rubber glove, or bleeding, after pulled syringe out, kept pressure on arm. Patient has never had anything like that happen. Patient did not provide NDC/lot/expiration for vaccine that made arm sore where put needle in. Never happened again after that. On 18 Mar2021, a paramedic gave vaccine and hit an artery, and injected the vaccine into his blood stream, when stood up patient couldn't breath and throat was like closed off and bleeding underneath skin above injection site, 7 droplets of blood above injection site. Patient still has one today that didn't go away yet. Patient stated that he suggested to the Paramedic that he pull out the needle and put it in the right arm and start over. Paramedic was just staring at the blood coming out underneath the syringe and continued to shoot the first dose Pfizer Covid Vaccine into the blood stream. After a few seconds caller's throat opened back up. States it was freaky. Never had that happen before. Throat opened back up, but scared patient real good. Just happened for a few seconds after standing up, maybe patient stood up too fast and that caused the problem. When patient got home he had blood on his arm and shirt. On 29Mar2021 11th day after first dose Pfizer Covid vaccine, patient experienced like a warm, hot forehead, gets warm and then gets hot like running a fever to the touch burning on forehead comes and goes, also patient started freezing all over the place, hands are ice cold, was wearing long johns two sweatshirts and a winter coat in house to be warm. Patient puts hands in coat pocket to warm up. This is still going on every day, still going on this morning. It started effecting different joints in the body, hit the muscle or joint, joints targeting on and off, still happening every day, No effect on joints yet. Patient hopes does not have anymore.. First symptom started after first dose Pfizer Covid vaccine, for seven days underneath the muscle. It was that 20 minutes one time it showed up. Patient clarifies that this began on the 7th day after receiving the first dose Pfizer Covid Vaccine. Patient had a little pain in the muscle. Felt something in the muscle are for about 20 minutes. It was ongoing and persisting. Also had a rash on right chest but it wasn't itching, it was just burning, strip of red rash going down left side of neck that went away and another rash started under left armpit. It was a pinching on the inside trying to come out through the skin. That's what the rash feels like. Reports this was still coming and going. Clarifies the rash underneath the right arm and on the chest is what patient was referring to. Last night for first time the rash itched underneath patients right arm in the muscle, it started to itch, still hot. It was never itching before but started itching last night, 20Apr2021. Rash came back on right arm between elbow and shoulder in muscle area. Red rash came, felt the pinching like trying to come out from under the skin. Patient went to the bathroom and looked and it was itchy for the first time. Patient didn't want to itch it, rubbed lightly with flat hand so nothing would happen. Improve a little bit, not all over chest like it was, going on in different locations of the body. On 20Apr2021, patient having a symptom from yesterday and today a pinching like pins and needles trying to get out on your stomach area, no rash there but it comes and goes. Patient pushes finger on it and it seems to calm it down a little bit. Reported this was another symptom that was appearing. Patient states he was still having these symptoms. On an unknown date in 2021, patient experienced severe sharp pain in head, he has a stabbing pain in forehead that comes and goes each day to this day. After that started experiencing, never had headaches before, that was a severe sharp in your head that comes and goes each day to this day. Treatment received ibuprofen 300mg once in a while to help knock pain down for joints hurt like heck. Patient doesn't know when he began taking, after symptoms occurred he began taking. Other than that the patient did not take it. Patient was not a big fan of taking medication. No relevant tests were done. Patient visited emergency room in a hospital due to events 01Apr2021. Patient was discharged from emergency room. Pleaded with emergency room to give patient an epi pen to stop the side effects from occurring to get back to normal life and not deal with problem. Emergency room refused to give patient the epi pen, saying the epi pen would give the caller high blood pressure. Patient does not have high blood pressure. Patient thought that would be better than the reactions he was having. Patient stated that gave him a steroid. Patient was hoping there was an anecdote to stop the side effects to not continue going through this problem. Shot was not designed for where it was put, guess have to deal with unless answers. Patient asked what are the long term effects to the brain at end of blood stream? Have any idea? Nobody has answered. Vaccine should have been aborted, not injected into blood stream. Patient underwent EKG (Electrocardiography) in emergency room on 01Apr2021 and result was unknown. Patients second dose was scheduled for 27Apr2021, 41 days after first dose Pfizer, not 21 days. The seriousness for all the events was unspecified. The outcome of event paramedic gave vaccine and hit an artery was unknown and for other events was not resolved. No follow-up attempts are needed. No further information is expected.

small red dots and sever itch starting on chest and shoulders extending down arms and side to include hips and buttock. stopped all antibiotics and started predesone pack

Plus one day: prickly all over; don't touch me feeling similar to the feeling at the beginning of a common cold or herpes outbreak. 600 mg ibuprofen mitigated symptoms Plus two days: rash covering 80% of abdomen

Patient is a pleasant 63-year-old gentleman who came to the hospital originally on 4/10/2021, refer you to the H&P done at that time by Dr. Comes in with a diffuse rash over his torso and his legs. He did get COVID vaccine, his first one (4/1/21 at Imaginetics) about a week to a week and a half before admission. He said shortly thereafter is when his symptoms began. The rash is pruritic. He had no breathing troubles whatsoever. No throat closing or tongue swelling, etc. No mouth lesions and in fact the rash over his torso and his back is pretty minimal, looks more like a sunburn type appearance. In any case, also had a petechial type of purpuric rash on his legs and I did show this to Dermatology who felt that it did look like vasculitis. He was placed on steroids. He did SOLU-MEDROL while here and this was converted to prednisone on discharge for which he will continue with for the next few weeks. Slow taper. Rash had improved over his stay here. His LFTs were also up somewhat as well, but these did improve while he was here and multiple imaging studies were done including ultrasound, CAT scan and abdominal Doppler all were negative for any kind of pathology. Suspect probably these elevated LFTs could have been from vasculitis and that is also improving now with the steroids. He is tolerating diet well. He has no abdominal pain. Okay to be discharged today. We will continue with prednisone taper. Follow with PCP in 1 week. Also know, there is an ANA pending as further workup for vasculitis. We will defer to PCP on follow up for that. 4/21/21 Follow-up with PCP: 63-year-old male here for a hospital follow-up. He was hospitalized for rash suspected to be vasculitis and elevated LFTs-started 2-3 days after his COVID vaccine. Etiology of elevated LFTs unclear. Liver US and CT were negative. Hepatitis, viral testing, and ANA negative. Received his first COVID vaccine on 4/1. Still on prednisone taper for rash. He is feeling better, still somewhat tired. Rash is almost resolved. Current complaints sore on the left side of his tongue for the past 11 days. Initially hurt when he would eat, is better now. Is back at work. Denies abdominal pain nausea, vomiting, stool changes, dark or light stools, yellowing of skin, swelling in abdomen or legs. Does not use tobacco, alcohol, or drugs. No history of liver issues. Normal LFTs 7 months ago. Follow up appt at Allergy/Immunology on 4/29/21: Plan: Patient had a delayed reaction to his 1st dose of Pfizer vaccination that included symptoms of arthralgias, rash as well as elevated liver enzymes. His symptoms don't meet criteria for type 1 IgE mediated reaction so skin testing would not be beneficial. His symptoms required hospitalization and improved with tapered steroid course. His symptoms did not fit DRESS syndrome criteria as he did not have peripheral eosinophilia, fevers, sloughing of skin/oral mucosa or blistering. We discussed how there is not much data or case reports about how to proceed with completing vaccination for COVID. I would recommend he get Johnson & Johnson vaccination since it is a different class of vaccine and he may not have the same reaction but again this is not guaranteed. There is a small chance of clotting with Johnson & Johnson vaccine as well. He should pre-medicate with cetirizine 20 mg po qday for 1 week before vaccination and 2 weeks after. I would also suggest he get a steroid course to have on hand from his PCP in case rash starts again after vaccination. It may be beneficial to have him get lab work several days after vaccination as well (U/A, CBC, CMP) to evaluate for any inflammation.

-abnormal reaction to covid-19 vaccination, states having lip swelling, body swelling, red rash in upper extremities, itching, chest tightness that resolved at the end of the day. -had an adverse reaction to 1st covid vaccine, pfizer, had facial swelling, leg and arm swelling, resolved after 24 hours

He feels like something is stuck in his eyes; eyes were itching; He has a lot of sickness; Left arm warm and pain after second shot; Left arm warm and pain after second shot/ arm was sore; This is a spontaneous report from a contactable consumer (patient). A 63-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: LL3302) via an unspecified route of administration at left arm on 05Feb2021 at 12:00 (63-year-old at time of vaccination), at single dose, for COVID-19 immunization. The patient's medical history included diabetes from 2009 or 2010 and ongoing; high blood pressure from 2009 or 2010 and ongoing; ongoing cirrhosis of the liver (As a little boy at 8 years old he got a cut on his right hand. His Mother took him to the Emergency Department and they gave him blood. All that time he didn't know, until he discovered it at age 32-34. He found out from his primary doctor he had Hepatitis C. His doctor asked if he shot up drugs. He said he did a little pot. He cut the main artery in his wrist); ongoing heart problems (He always felt problems with his heart. It started in 2014 when he went to the Emergency Room for pain in his chest. They checked his heart and found his blood didn't flow to the right. It flowed to the left. The Cardiologist told him sometimes his heart beats and sometime it doesn't. He had 2 veins with blockage, they couldn't do anything and put him on medication for that); prostate cancer From Dec2019 (He had Cancer twice. He was first diagnosed of Prostate Cancer and received Radiation therapy. He had an exam and the Cancer was back. He had surgery for the Prostate Cancer 18Feb2020); COVID-19 (in the past. His wife had COVID-19 and he had COVID with the same symptoms. He lost his taste for 9 days at the end of Dec2020. He got sick after his wife had COVID-19. His wife got better after having COVID-19. He had no appetite, it was pretty bad). Concomitant medications included a lot of medication (Details were not provided). The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: BL3302) via an unspecified route of administration at left arm on 14Jan2021 at 16:30 (62-year-old at time of vaccination), at 0.3ml, single, for COVID-19 immunization and experienced left arm hurt. There were no prior vaccinations within 4 weeks. There were no additional vaccines administered on same date of the Pfizer suspect. History of all previous immunization with the Pfizer vaccine considered as suspect was none. Patient weighs between 158-159 pounds. Patient experienced left arm warm and pain after second shot was from 05Feb2021 to 06Feb2021. Patient states he received the second dose on 05Feb2021 and within 30 minutes he started to feel the shot, it was working up in his head, felt like something was working. It was warm and sore. Patient states a couple hours later he was taking Tylenol because his arm was sore. He applied the muscle rub/muscle wrap the next day and it was better. Patient states the day before reporting he began using eyedrops more than usual and using 5 drops because he feels like something is stuck in his eyes. States it's almost like COVID is in his eyes. In the past month he has been using eye drops more often. He had been using them before the vaccine. His eyes were itching and he would use the drops to flush them out. Patient would like to know if feeling like something is in the eye is something related to the vaccine or a symptom of COVID-19. He has a lot of sickness. Adverse events did not require a visit to emergency room or physician office. The outcome of Left arm warm and pain after second shot was recovered on 06Feb2021; outcome of other events was unknown. No follow-up attempts are needed. No further information is expected.

Within 5 minutes of getting shot, my right forearm and hand tingled, turned red and started swelling. Next, I felt dizzy and light headed. A nurse then placed a BP cuff on me and measured my BP at 185/150. My oxygen level was 98. My face, neck and arms turned very red and my face - cheeks, nose and lips started to swell. They gave me apple juice and crackers. After about 45 minutes, my right arm was normal, the color in my face, neck and arms returned to normal, my BP was 150/90. My cheeks, nose and lips remained swollen. After another hour passed, I felt ok, so I left. I took Zyrtec and then Benadril, but they didn't help. My doctor prescribed prednisone but took me off of it after 3 days as it had no affect. After a week, the swelling in my cheeks and nose subsided, but as of today 5-6-21 my lips are still swollen.

Client received first vaccine on 03/13/2021. Client states woke on 03/29/2021 and noted right hand was swollen with itchy, red raised areas. Client states seen physician on 03/30/2021 and was given an antibiotic and ointment. Client received second vaccine on 04/03/2021 and when he woke on 04/04/2021 he had similar symptoms he had to his right hand to his neck, left armpit, and right calf area; symptoms consist of itchy red raised "bump" areas. Client states the "bumps" are intermittent and last approximately 3 days, but prior to the bump resolving new bump appear each day. Client states right hand symptoms resolved on 05/01/2021.

Pneumonia; Itchy, dry, non-productive cough; Itchy, dry, non-productive cough; Itchy, dry, non-productive cough; This is a spontaneous report from a contactable consumer (reporting for self). A 63-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE),dose 1 via an unspecified route of administration, administered in Left Arm on 03Apr2021 (Batch/Lot Number: ER8732) as SINGLE DOSE (at the age of 63 years) for covid-19 immunisation. Medical history included ongoing chronic obstructive pulmonary disease (diagnosed for a decade), ongoing hypertension (diagnosed for a decade), ongoing type 2 diabetes mellitus (5-6 years ago diagnosed, very well maintained type 2 diabetes), ongoing pneumonia (He has been hospitalized 4 different times for pneumonia. In Dec2020 when he had pneumonia, they did not hospitalize him. He has had pneumonia 5 time since 1982. Concomitant medication included lisinopril (LISINOPRIL) taken for an unspecified indication, start and stop date were not reported. "He gets the flu shot every, and he has had the shingles shot. He also gets the pneumonia vaccine every 2 years." The patient experienced pneumonia (hospitalization) on an unspecified date with outcome of not recovered, itchy, on 08Apr2021 with outcome of unknown, dry cough on 08Apr2021 with outcome of not recovered and non-productive cough on 08Apr2021 with outcome of not recovered. The patient underwent lab tests and procedures which included sars-cov-2 test: unknown results on Oct2020. On 13Apr2021 He reported it to the doctor and he told the patient to skip a dose of Lisinopril that sometimes it can have those symptoms of a deep nonproductive cough. He skipped the medication, and it hasn't gotten better. He thinks it is from the COVID vaccine. At the peak of his cough, he probably had 6 days where he coughed uncontrollably for 24 hours in a day. He still has a cough. Therapeutic measures were taken as a result of pneumonia. The doctor didn't do a chest X-ray or COVID test.

Rash is getting worse; severe rash on lower right leg with blistering and swelling; burning sensation to the touch; burning sensation to the touch; severe rash on lower right leg with blistering and swelling; severe rash on lower right leg with blistering and swelling; extreme chills est 3hrs; body ache all over; nausea; This is a spontaneous report received a contactable consumer, the patient. A 63-year-old adult male received the second dose of BNT162b2 (solution for injection; Lot ER8731 and expiry information not provided) as a single dose via unspecified route in the left arm on 21Apr2021 at 10:15 (at 63-years-old) for COVID-19 immunisation. Relevant medical history included Diabetes and High Blood Pressure. Concomitant medications sans indications, posology and therapy dates included carvedilol; losartan potassium; and levothyroxine sodium. The patient previously received COVID-19 immunisation with the first dose of BNT162b2 (Lot ER8735) in the left arm on 30Mar2021 at 11:45 (at 63-years-old). The patient denied any known allergies or any COVID-19 prior to the vaccine. The patient denied receiving any other vaccine within four weeks prior to this vaccine. On 21Apr2021 at 23:30, reported as twelve hours after receiving the vaccine, the patient began to experience extreme chills est 3 hrs, body aches all over, and nausea. On 22Apr2021 at 10:15, reported as twenty-four hours after receiving the vaccine, the patient developed a severe rash on lower right leg with blistering and swelling. The patient described the rash as going from ankle to knee, and no itchiness just a burning sensation to the touch. The patient reported that he had not yet sought medical attention though planned to go to the emergency room (ER) for the rash as it was getting worse. The patient denied any COVID testing since receiving the vaccine. It was reported unknown if any treatment was received. The outcome of the events extreme chills est 3 hrs, body aches all over, nausea, severe rash on lower right leg with blistering, burning sensation to the touch, and getting worse, was not recovered.

First: April 25~27: Sore Arm, similar to a bruised muscle. Second: April 27 my right forehead just below the hairline and in the right ear area where the top of the ear meets the head, had minor itching and were turning red. On April 28. Hives began on my left arm's lower wrist and in the general area of my right leg's knee. The hives became more numerous in these areas until a general red rash condition was appearing between them as well. By Saturday Morning May 1 the knee and wrist areas were noticeably red like a rash and hives were also appearing with itching below the right knee on the upper half of my shin, above this knee, on my right lower wrist and on my left lower fore arm. My right ear was starting to swell at just the top. I tried putting Gold Bond Medicated Powder on these areas, but it didn't reduce the itching much. Sunday May 2, I called my mom who is a Registered Nurse about this. She advised going to my health care provider to substantiate these symptoms. Monday May 3 I visited my health care provider's office after work and got an appointment for Tuesday at 10:15 from a cancellation. One of their RN's looked at my hives and rashes. New hives had now also formed on my left leg just below the knee on the back side. It was a red string of itching a couple inches long. I called my boss Tuesday so I could take the day off for the appointment and he agreed that I should do this. At the doctor's office, PA-C after extensive questioning and examination said he thought this was an allergic reaction possibly related to the polyethylene content of the vaccination. He further advised that I not get the second shot until I was checked by an allergist. He put in a referral for this. I think I picked up cold-like symptoms (sore throat and cough) from the doctor's office that were minor. Wednesday morning I had much worse symptoms. I was weak, groggy, couldn't think without great effort, was more itchy, and my right knee was starting to ooze. I called my boss at work to take the day off since I was quite sure driving would be risky, and that I would have to leave work early for lack of energy. My right front thigh had a new area of hives along with my right and left fore arms. I started treating all my affected areas with Caladryl topical Analgesic and taking generic Benedryl. I had breakfast and then slept until 2:30 PM, had lunch and slept until evening. By then my forehead and right ear areas had reduced in severity. I had lost (2) days of work. The rest of the week, all my symptoms diminished. As of this writing Sunday May 9, my knee is still tender, sore, and red, and left wrist hives are still pronounced.

has reflux, gas and bloating/gas and acid reflux is worse; has reflux, gas and bloating/gas and acid reflux is worse; has reflux, gas and bloating; he is so tired; hard time breathing from gas/ had a hard time breathing last night; hives on his face on both sides of his cheeks; disturbance on his throat; felt like something was blocking his throat; This is the spontaneous report from a contactable consumer (patient wife). A 63-year-old male (patient) received BNT162B2 (lot number: EW0158) first dose on 14Apr2021 16 15 PM on left arm at single dose for COVID-19 immunisation. Medical history included allergic to milk and beef, gives him hives on his face. Concomitant medications included nasal spray (he doesn't take any other medication). No Prior Vaccinations (within 4 weeks). Consumer asked if her husband can take benadryl before the vaccine. Consumer stated her husband has no known allergies to medications. Caller stated that her husband had the first dose of the Pfizer covid 19 vaccine on 14Apr2021 at about 4:00 pm. Caller stated he ate dinner and then around 8;00 or 8:30 he felt like a disturbance on his throat. Caller stated he could swallow but felt like something was blocking his throat. Caller stated that 1/2 hour later it went away. Caller reported the next day (15Apr2021) he had hives on his face on both sides of his cheeks. He is so tired. Caller stated her husband has reflux, gas and bloating. Hard time breathing from gas. Caller stated her husband had a hard time breathing from gas last night (20Apr2021). Gas and acid reflux is worse on 20Apr2021. Vaccine Administered at Military Facility was no. No event require a visit to: Emergency Room or physician office. The outcome of event disturbance on his throat was recovered on 14Apr2021, hives on his face on both sides of his cheeks recovered on 15Apr2021, gas and acid reflux is worse recovered on 21Apr2021, hard time breathing from gas/ had a hard time breathing last night was recovered on 21Apr2021. The outcome of other event was unknown. No follow-up attempts are needed. No further information is expected.

scabbing; shingles; marking that showed up on the face/sore dried up on his face; allergic reaction; swelling on neck and cheek; swelling on neck and cheek; tooth ache; stuffiness in ear; pain right side of the face; This is a spontaneous report from a contactable consumer (patient). A 63-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN6207), via an unspecified route of administration, administered in arm on 19Mar2021 10:00 (at the age of 63 years old) as 1st dose, single "to get myself vaccinated". Medical history was reported as none. There were no concomitant medications. The patient called about the COVID 19 vaccine, stated that he had side effects that he felt he needed to report and questioned if he needed to know anything before getting the second dose. He stated that he received the first dose on 19Mar2021 and on Sunday (21Mar2021) he began to have symptoms. He stated on Sunday 21Mar2021, he had swelling on his neck and cheek and stuffiness in his ear which he thought might had been a tooth ache or an allergic reaction. He stated that a few days after those symptoms developed he had pain on the right side of his face on 21Mar2021 and markings that showed up on his face on 22Mar2021. Further stated that he went to the urgent care as there was no need to go to the emergency room on 25Mar2021 and was diagnosed with shingles. He began treatment that day for shingles on his right side of his face and it was a seven day course of medication and his last treatment will be finished at the end of that day of the report. He reported that the markings were better and he did not have nerve pain and the sore dried up on his face which was consistent. He went to the doctor on 29Mar2021 just to be on the safe side and the symptoms seemed to be better. He received the next vaccine on 09Apr2021. Further stated he thought it would be good to report his symptoms and see if there was anything Pfizer could tell him. Further stated that the scabbing on unspecified date was getting better. Treatment was valacyclovir. Therapeutic measures were taken as a result of all of the events. The outcome of the event tooth ache and allergic reaction were unknown; pain right side of the face was resolved on 29Mar2021; stuffiness in ear, swelling on neck and cheek were recovered on 31Mar2021; shingles and marking that showed up on the face were recovering.

You gave me shingles thanks alot for the warning. Severe muscle pain entire upper body. Rash from outbreak. Inability to sleep due to not being able to rest for 5 days. Hard to breathe. Worst 5 days ever for a totally healthy person.

DOSE 1 ON MARCH 16, 2021; DOSE 2 ON APRIL 13, 2021; SEVERE PAIN STIFFNESS, TETANUS, ACHES, FATIGUE, MORE PAIN SAME DAY FOLLOWING FIRST INJECTION.... MUMPS-LIKE SYMPTOMS... PAIN FROM INJECTION SITE , UP NECK, BACK OF HEAD... TOTALLY DEBILITATING PAIN WORSE IN EVENINGS AND PAIN "MOVING" FROM ARM TO NECK TO HEAD AND BACK...WORSE AT NIGHT.... SAME SYMPTOMS WITH EACH DOSE... 2 MONTHS NOW! PAIN LASTED 4 WEEKS AND WAS REMITTING AT TIME OF SECOND INJECTION; SEVERE PAIN STIFFNESS, TETANUS, ACHES, FATIGUE, MORE PAIN SAME DAY FOLLOWING SECOND INJECTION (I WAS ALMOST BETTER AND THEN BACK TO WORSE THAN FIRST DOSE! WAY WORSE! PAIN LASTED 4 WEEKS AND IS CONTINUING NOW

PATIENT REPORTED HAVING SEVERE HIVES AFTER INJECTION. THEY DID NOT APPEAR ON SAME DAY, BUT ON ONE OF THE FOLLOWING DAYS (HE COULD NOT SPECIFY). PT REPORTED THEY WENT AWAY AFTER A WEEK AND HE DID NOT "FEEL RIGHT" FOR ABOUT A WEEK AROUND THE HIVES.

testicles swelling; experienced a rash three hours after the vaccine; fever; chills; diarrhea; Malaise; they gave him a quick test that said he had covid; This is a spontaneous report from a contactable consumer (patient). A 63 -year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: unknown) via an unspecified route of administration in left arm on 15Apr2021 at 10:30 (at the age of 63 years old) as single dose for COVID-19 immunization. Patient's medical history included asthma and it was diagnosed years ago. Concomitant medications were not reported. On 15Apr2021, the patient experienced fairly, fever, chills, testicles swelling, and diarrhea, malaise, COVID-19 and rash three hours after the vaccine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient reported symptoms went on for several days and began on 15Apr2021 about three hours after he was administered the 1st dose of the Pfizer COVID vaccine and the symptoms resolved probably 7 days later. Patient do not have prior vaccine side effects. Patient did not require treatment but for one thing he did call to HCP and was sent for a COVID test and it came back negative, and it was the one that takes three days, states patient still did not feel good so that same day patient first COVID test on 23Apr2021 patient went to another COVID test at and they gave him a quick test in that result patient had COVID. Outcome of the events fever, chills, diarrhea, malaise was recovered and testicular swelling, rash, COVID-19 was unknown. Information on the lot/batch number has been requested.

Mild soreness and fever two days . followed by persistent extremr fatigue nausea headache itching, easy bruiising and bleedind Sick for 6 weeks. No improvement

He got his vaccine, immediately where the needle went in he had a bruise and just stayed the same. Then a few days later he started feeling stiffness and pain in his right neck and shoulder area. He did not have any rash, fever or other symptoms. He does still have the swelling at the injection site. He has taken Aleve for the discomfort. He has not called his doctor. He is able to work, but is having the pain in the neck and the shoulder every day.

Soreness and pain, sometimes very sharp, in upper arm in area of injection since receiving first dose. Arm was still sore when second injection was received on 5/5/2021. Upper arm area around injection area is still very sore. Sharp pains are a constant. Pain makes a sound sleep almost impossible at night. Pain disrupts sleep and must put my arm above my head to help lesson the pain. I will be making an appointment to my primary health care provider in near future.

Patient noted petechial rash on his hands on 5/18/21. On 5/19/21, patient woke up and noted a blood blister on inside of his cheek. On the morning of 5/20/21, patient noted many more additional blisters with more petechial rash on his lower legs and arms. Patient called PCP, who ordered CBC. Patient presented to the hospital in the evening of 5/20/21. Patient remains hospitalized. Received high dose IV corticosteroids, IVIG. Now on oral high dose corticosteroids, received vincristine 2 mg and Nplate 10 mcg/kg/dose 5/27/21. Received multiple platelet transfusions. Refractory, no improvement observed as of 5/28/21.

Patient reports week-long, not yet resolved, numbness in fingers, pain in elbow of injected arm. Also ?hard to bend? and injected arm ?darker than other arm?

Patient states he experienced hives bilaterally on his forearms two weeks after receiving first dose of Pfizer vaccine. Patient states symptoms lasted "a few days" and resolved on their own without intervention. Patient did not seek medical care. Patient received dose #2 of Pfizer on 5/28/2021.

Shingles outbreak on left arm from shoulder to wrist. Began 17 days after 2nd dose of vaccine. Rash with pustules.

Total two injections. During time between vaccine injections developed COVID-19 infection subsequently given bamlanivimab infusion. 90 days post infusion given second vaccine injection. As indicated noticed several petechiae developing on both calves.

my left top forearm started itching; purpura; Urticaria/Hives; swelling; This is a spontaneous report from a contactable consumer. A 63-year-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 02Mar2021 10:30 (Batch/Lot Number: EN6200) as 1st dose, single for covid-19 immunization. The patient's medical history included peripheral arterial occlusive disease (PAD), chronic obstructive pulmonary disease (COPD), osteoarthritis (OA) and known allergies to CT contrast dye. Concomitant medications included prednisone; rivaroxaban (XARELTO); rosuvastatin calcium (CRESTOR); aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]) all were taken for an unspecified indication, start and stop date were not reported. The patient previously took Interferon, Ribavirin for 48 weeks then Inf, Riba, Telapriver for 48 weeks between 2009 and 2012 and patient had purpura. The patient previously given Hep C and had leukocytoclastic vasculitis and cryoboluenemia (sp due to Hep C). On 03Mar2021, Wednesday evening at 17:00 approximately 28 hours after vaccination, the patient's left top forearm started itching followed by purpura and urticaria. By midnight it was much worse. Patient used Benedryl itch relief spray and Boudreaux's Butt Paste till he got hydrocortisone cream, calamine lotion and Benadryl tablets in Saturday morning. It was Wednesday night and for the 1st time he was not itching. The itching was gone. The Hives (rise) was gone. The purpura was now bursting and draining clearish. The swelling was all but gone. It was reported that other than the oozing purpura, all is good now. Patient would like to know if he should get the 2nd shot, in different arm. The outcome of the event purpura was recovering and recovered on unknown date from all the other events.

hives that started on his foot and they moved up to his legs and his abdomen.; itching; This is a spontaneous report from a contactable consumer (patient) reporting himself. A 63-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number: EW0179) via an unspecified route of administration in Arm Left on 08May2021 as second dose, single dose for covid-19 immunization. Medical history included, high blood pressure, Allergy, kind of dry eye also have bulging disc at his back, squeezing out to the nerve that why he have to chair, phlebotomy. Patient had took first dose of BNT162B2. Concomitant medication included amlodipine besilate (NORVAS) taken for high blood pressure, atorvastatin (LIPITOR [ATORVASTATIN]), losartan (LOSARTAN), aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]) taken for an for heart, amlodipine (AMLODIPINE), verapamil (VERAPAMIL), hctz (HCTZ), cetirizine hydrochloride (ZYRTEC ALLERGY) taken for hypersensitivity, gabapentin (GABAPENTIN), oxycodone (OXYCODONE),metoprolol succinate (TOPROL XL), ascorbic acid (VITAMIN-C). The patient reported that he received his second dose of the vaccine on 08May2021 and later began noticing hives that started on his foot and they moved up to his legs and his abdomen he saw his primary care physician who prescribed a cream for the itching, but itching hasn't gone away and doesn't know if he should get checked out at the emergency room because the hives are still bothering him or if they will just go away. Upon follow-up (22May2021), event reported as he got reaction almost from this Pfizer vaccine, he was asking should he have to go to emergency room and he got hives popping up different places on his body and it like a really bad. He went to doctor yesterday they said they don't know what is going on, he thought what could be the vaccine, we don't know, past they told me hives is the side effects, then he have been on phone for a last couple of hours, and gotten anywhere, he is not getting anything from doctor or anybody. Last Saturday his foot broke out just once but now just same keep coming all over his body and he took to the doctor they said they don't know where it's coming from, so he think with that part of shot picks it up vaccine what led him to do. He still have concern about hives over his body, it is itching little bit. It was started last sunday on the 16th. This just started after he had the vaccine, he had not it before. Consumer stated, he just want to know if I need to to go to the emergency room, do he need to worry about it. The patient underwent lab tests and procedures which included blood test. Therapeutic measures were taken as a result of itching (pruritus) with Loratadine. The outcome of events was unknown. Follow-up actions are required. Further information requested

light headed; Chills; Nausea; Pain/Soreness at injection site; Tiredness; This is a spontaneous report from a contactable consumer, the patient. A 63-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EN6206,) via an unspecified route of administration in the left arm on 16Mar2021 at 11:30 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. Medical history included heart disease. The patient did not have any allergies to medications, food, or other products. Concomitant medications included Atorvastatin (MANUFACTURER: UNKNOWN) for an unknown indication, Metoprolol (MANUFACTURER: UNKNOWN) for an unknown indication, Lisinopril (MANUFACTURER: UNKNOWN) for an unknown indication and Tamsulosin (FLOMAX) for an unknown indication. Since the vaccination, the patient had not been tested for COVID-19. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 16Mar2021, the patient experienced chills, nausea, pain/soreness at injection site, tiredness and light headed. The clinical outcome of the chills, nausea, pain/soreness at injection site, tiredness and light headed were recovering at the time of report. No follow-up attempts are needed. No further information is expected.

Site: Bruising at Injection Site-Mild, Additional Details: Patient presented green bruise with slight capillary rupture under the skin. Claims started 8 days ago on day of vaccination

Zoster lesions appeared on 6/5/2021 on my left arm...same arm used for both Covid vaccine injections...about six weeks out from second dose. I had prodromal symptoms for few days before rash appeared. As the appearance of the shingles rash occurred on a weekend, I was seen by MD at an Urgent Care Center to get started on antivirals asap. She prescribed Valacyclovir 1gm TID for 7 days orally and Mometasone 0.1% cream topically to lesions BID.

Site: Pain at Injection Site-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Systemic: Numbness (specify: facial area, extremities)-Severe, Additional Details: Injection site still sore 1 month after 2nd shot. Rash still present around injection site. Numbness from left forearm to hand gradually increased over days & weeks & is now completely numb & patient struggles to use hand & grip/pick up things. Hasn't seen MD yet since he's concerned about cost. Said this never happened before.

Pt notes "lump" after first vaccination ~3 weeks ago. No pain, erythema. No systemic signs of infection. PE: 2 cm mobile firm fluid-filled sac upper right arm. Non-tender. Skin pristine. Likely seroma, less likely hematoma, other. OK to vaccinate the other arm. Advised local measures and calling PCP. Advised urgent call with erythema, enlargement, systemic.

Prickles on the surface of both forearms, but only after cycling. Within a few hours after cycling, then the prickles shrink back, and the skin is smoother. I've been treating the skin area with a cream called, Cortizone-10, Ultra Moisturizer. Five times since May 30th I have gone cycling, and all five times after cycling I see the prickles. They look just like the story from this lady, post-vaccine,

I had a rash appear and it was very itchy. Discoloration on my skin at site of the injection. I called doctor, they said I should put a hot towel on it and keep the area clean and it should go away. My arm was sore.

"Pfizer-BioNTech COVID-19 Vaccine EUA" Three days after shot #1, (6-11-2021) I started to get rash-like raised bumps in several locations. Chest, back of right arm, back of left knee, bicep of right arm. Then 5 days and 10 hours, 6-13-2021, 10pm, I got achy, followed by the chills and then a fever. Lasted for 2 hrs, then the fever lasted longer into the night. What concerns me is the rash/bumps in different places and then the delayed symptoms. With this being the 1st shot, I do not think I will fair well with a 2nd shot.

I developed a severe rash on the left side of my chest and left arm. Diagnosed as shingles after a night in the hospital.

broke out with a rash, and it itched. Caller states if he scratched it, it is going to turn into a cut. Stomach, Under his Arms, Between his Legs by his Thighs; really dry.; This is a spontaneous report from a contactable consumer (patient). A 63-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EL3302), via an unspecified route of administration, administered in Arm Right on 03Feb2021 (probably between 12-13:00) as 2ND DOSE, SINGLE DOSE for covid-19 immunisation at Pharmacy. Medical history included, Shingles shot from an unknown date and unknown if ongoing. Family history reported as none and no relevant test performed. The patient's concomitant medications were not reported. History of all previous immunization with the Pfizer vaccine considered as suspect was not available. List all vaccines administered on same date with the Pfizer vaccine considered as suspect reported as none. Patient was not received any other vaccine prior four weeks of vaccination. Patient's historical vaccine include first dose of BNT162B2 (Lot Number / Expiry Date: EL3302), via an unspecified route of administration, administered in Arm Right on 12Jan2021(at the age of 63) for COVID-19 immunization. On Feb2021 the patient experienced broke out with a rash, and it itched. caller states if he scratched it, it is going to turn into a cut. stomach, under his arms, between his legs by his thighs really dry. He stated when they gave him his first vaccine, a whole year and he didn't have no rash or nothing, then after his first vaccine he was normal, but then after his second vaccine, a week later, he broke out with a rash and it is really bad now. caller states maybe it was last month or something. Caller states if Pfizer wants to take pictures of it, they can. Caller states the rash is by his arm pits and between his legs. Caller states it is really bad on his right leg almost by his thigh, the top part of his leg. Caller states it is really dry and now it is starting on the left side of his leg. Caller states it hasn't gotten to his feet or his face. Caller states he has got an apartment, but he is going to be at Friendship Manor for a while for Physical Therapy. Caller states he is not sure of the exact start date. He states it was 1.5 weeks after his second vaccine and it was in February. Caller states it is not getting really bad, it is not going everywhere. Caller states it is only in certain parts of his body and it hasn't stopped. Caller would only answer ongoing. Caller states there are nurses there, and he asked what it was, and they said they didn't know what it is, but the people there put some cream on it, but that isn't working. Caller states he doesn't know the name of the cream, some kind medicine. He states probably prescribed by doctor. Caller states recently he got his Shingles shot like a couple of weeks ago. Nothing happened with it, he is supposed to go back and get another one. Caller states this was recent and his Covid shot was way back in February. Caller states he isn't never had a rash, chicken pox, measles, no nothing. Patient visited to physician's office foe the event. Therapeutic measures were taken as a result of the events. The outcome of the event was reported as not recovered. Follow-up attempts are needed. Further information is expected.

This was after second covid vaccine-rash on arms legs and stomach doctors have tried many treatments nothing has worked; This is a spontaneous report received from a contactable consumer (patient). This 63-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 13Apr2021 12:00 PM at age of 63-year-old as 2nd dose, single for COVID-19 immunisation. Medical history included diabetes and heart stent. No known allergies. No covid prior vaccination. Concomitant medications included apixaban (ELIQUIS), empagliflozin (JARDIANCE), metformin, and clopidogrel bisulfate (PLAVIX). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. This was after second covid vaccine on 16Apr2021 08:00 AM, rash on arms legs and stomach doctors have tried many treatments nothing has worked. Event resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Since the vaccination, has the patient had not been tested for COVID-19. Different prescription creams and prednisone received. Outcome of the event was not recovered. Information about batch/lot number has been requested.

Shingles presented on the morning of June 1. Skin lesion eruptions occurred on my right underarm and in a circular ring around my right chest. I have never had shingles before in my entire life. It's now June 20 and the lesions are starting to recede, however I am experiencing extreme "jabbing" and "searing" discomfort under the skin around my right rib cage and right underarm consistent with the locations of the shingles lesions.

postponed his second dose until they see what is going on and they improve his 02 sat; it will be 35 days this coming Monday since his first vaccine; Tachycardia; Sweating Profusely; Itching at the Injection Site; Very Tired; Low 02 Saturdationg; This is a spontaneous report from a contactable nurse. This contactable nurse reported for 63-year-old male patient (reporter's husband) A 63-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection: Lot number: EWO709), via an unspecified route of administration on 17May2021 as a single dose for COVID-19 immunisation. 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. COVID prior vaccination was none. Historical vaccine included Hepatitis B vaccine. The patient's medical history included allergy, fatty liver, weight loss, Irritation of Nasopharynx, Granuloma (//2020). The caller stated that on May/2021, about less than 2 weeks after receiving the first dose, the patient started to feel very tired and his O2 saturation while resting was 90-93 on room air and with deep breathing he reached 95, but while he was laying down and sleeping it drops below 90. The reporter stated that the patient had no fever and no inflammation except a little itching at the injection site. The reporter also stated that the patient was excessively tired and sleeps every day. Stated that they didn't really pay attention to when tiredness started, but it was around the last week of May. The reporter stated that they had a weight trainer who comes to the house. The patient stated that her husband felt exhausted during the weight training and couldn't do his workout. Caller stated that she has tried to associate it with other things, the low 02 sat and said that it could be something else. It was reported that he has no coughing and no shortness of breath. It was stated that on 27May2021, her husband was really pooped. The reporter stated that she had him walked with the Pulse Ox and they went outside and had him run a little bit and do a little bit of cardio and his heart rate went up to. Caller stated that he was tachy and it stayed for a day after he ran and stated that it was after he ran in the evening and through the following day. Caller stated that he took some Raw Garlic because it helped when he was tachy before. Caller stated that her husband didn't directly complain of the arm side effects, it was more of her asking whether he was having any side effects, and he said just a little itch, no redness or swelling. The reporter stated that he was laughing about the shot, and had no body aches or tears, just itching on the deltoid area for just a few days and as time progressed, he started to feel more tired. Caller stated that the Low O2 Saturation has improved. Caller stated that she had him do the incentive spirometry and it was gradually starting to go up. Caller stated that they haven't checked his sleep tracking devices yet. Caller stated that on the same arm he wears a Garmin and a Fit Bit to make sure he was not going crazy. Caller stated that at night his O2 saturation level dropped to 88 for long periods of time. Caller stated that they ordered a Garmin night sleep tracking device from, towards the first of June. Caller stated that she was checking him with 2 pulse oximeters and then she ordered the Garmin on 01Jun2021. The reporter stated that low O2 saturation started towards the end of May, may be on 28-31 May. The patient had a physician office visit due to the events. Caller stated that they have postponed his second dose until they see what was going on and they wanted to improve his 02 saturation. Caller stated that the patient was able to walk 5 miles 2-3 times a week and did swimming. Caller stated that the patient was concerned about his low 02 saturation. Caller wanted to report this and the doctors did not know what to do with the second vaccine. Caller stated that it will be 35 days this coming (Monday) since his first vaccine. Caller was asking whether the low 02 Saturation can be a side effect of the vaccine. The patient underwent lab tests and procedures which included CT and pulmonary tests done with normal results. The patient o2 saturation level tests with unspecified results. The reporter assessed the events to be related with the suspect product. The outcome of the events was not resolved for fatigue, oxygen saturation decreased, unknown for 35 days this coming Monday since his first vaccine and resolved for other events. Follow-up (17Jun2021)- Follow-up information was received from the same contactable nurse included non-clinical information Information on Lot/Batch number was available. Additional information has been requested.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available.

This is a spontaneous report from a contactable consumer or other non HCP (patient himself). A 63-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0171), dose 2 via an unspecified route of administration, administered in Arm Right on 27Apr2021 (at the age of 63-years-old) as 2nd dose, single for COVID-19 immunization. The patient's medical history included ongoing diabetes mellitus diagnosed decades ago and wasn't feeling good from Dec2020 to an unknown date. The patient's concomitant medications were not reported. The patient took 1 dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EP7534) via an unspecified route of administration, administered in Arm Left on 05Apr2021 at 10:00 AM as 1st dose, single for COVID-19 immunization and no reaction on exposure to vaccine. The patient had no history of previous immunization with the Pfizer vaccine. No additional vaccines administered on same date of the Pfizer suspect. No any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. The patient stated he went to the hospital because he wasn't feeling good in Dec2020 of last year and all the test results were fine, so he got his first vaccine, believes it was, 05Apr2021 for the first dose and 27Apr2021 for the second one. After that, the patient had extreme itching in his body and his liver enzymes are off and he just wanted to report what was going. The itching began after the first shot in Apr2021. He had to go to the hospital one time, and he had to go to the doctor 3 times, they say liver enzymes are off. He has a copy of the test. The patient stated prior to that, they were way higher when he went to the doctor. The patient's blood urea nitrogen (BUN) was 25 high, Aspartate aminotransferase (AST) was 100 high, Alanine aminotransferase (ALT) 176 high, alkaline phosphatase was 318 high, albumin was 3.2 low. He was also lost like 30 pounds. He has been experiencing extremely dizzy. Sometimes he stands up and he feels very dizzy and sometimes he feels strange, he has no other way to explain. He doesn't feel himself. He stated 8 days after the shot, he started feeling bad. It all started all together. The patient stated Pfizer can get that information from the doctor, he doesn't feel so good to keep up with that. The patient stated the extreme itching and extremely dizzy was worsened, that's why he had to go to the emergency room on 11Jun2021. Regarding the liver enzymes were off the patient stated, Pfizer can speak to the doctor. His doctor knows who he was and will give specifics. According to his doctor, the doctor was going to report it wherever it has to be reported to. He doesn't feel good, he was itching, and he doesn't know what to do about it. The event extreme itching and extremely dizzy required emergency room and physician office visit. The outcome of the events extreme itching and extremely dizzy was not recovered. The outcome of the events liver enzymes are off, lost like 30 pounds and he feels strange was unknown.

doesn't feel anything and is unsure if the medication was injected in his body; has a little pain at injection site; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 63-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 13Feb2021 16:30 (age at vaccination was 63 years) (Batch/Lot Number: EL9269) as 2nd dose, single at hospital for covid-19 immunization. The patient medical history was not reported. There were no concomitant medications. On an unspecified date after the vaccination the patient did not felt anything, he did not feel the needle, and was unsure if the medication was injected in his body and he also had a little pain at injection site. Patient did not receive any treatment to events. The outcome of the events was unknown. Follow-up attempts are completed. No further information is expected.

The first day, I was fine. The next day, I was fatigued. Over the weekend, I was very exhausted. I did not have any sweats or anything. Easter weekend, that's when it all hit. I woke up at midnight feeling ice cold to the point that I couldn't get up to get another blanket. I slept pretty much all day the next day. About a week or so later, I started noticed little red bumps on my ankles that itched. It then spread to my knees, elbows, and lower arms. That was towards the middle of April. I kind of ignored it. I began to wonder if I was having a reaction to the shot. I started hearing a ringing in my left ear and I am still experiencing that. My PCP told me to see a dermatologist after looking at the bumps because he didn't know. I saw the dermatologist on May 19, 2021. He told me to take Zyrtec 3xday. My PCP told me to take prednisone and it didn't do anything. I also saw an ENT on June 8, 2021. He did a hearing test and said there was some loss of hearing in my left ear. He put me on an extended period of prednisone. It did not make it go away in my case. I went back to see him about 2 weeks later. He recommended for me to have a cortisone injection into the ear drum or behind the ear drum. I decided not to do that. My PCP concurred with my decision. The red bumps are now sporadic. Every 3 or 4 days they show up. I think whatever is causing it is now moving through my system. I have noticed a change in my eye sight on the left side. I have a scheduled eye doctor appointment on July 6, 2021. I have noticed an all of a sudden difference in the last 6 weeks.

Fever; chills; pain at injection site; headaches; muscle pains; joint pains; nausea; vomiting; feeling unwell; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: ER8730), via an unspecified route of administration on the right arm on 20Mar2021 at 15:00 (at the age of 63-year-old), as an unknown single dose for COVID-19 immunisation. Medical history included hypertension and colon cancer. Concomitant medications were not reported. The patient did not have any allergies to medications, food or other products. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 21Mar2021 at 1300, the patient experienced fever, chills, pain at injection site, headaches, muscle pains, joint pains, nausea, vomiting and feeling unwell. The patient received other medication within two weeks of vaccination. Tylenol and Motrin was taken as therapeutic measures as a result of adverse events. 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 events fever, chills, pain at injection site, headaches, muscle pains, joint pains, nausea, vomiting and feeling unwell was resolved on an unknown date. No follow-up attempts are needed. No further information is expected.

Injection site pain; Upper body muscle crumps/severe pain - most around neck area; Swollen lymph nodes; Headaches/ Any body movement causing head pain; neck pain/ Any body movement causing neck; Tiredness; Felling unwell; Dizziness; weakness; This is a spontaneous report from a contactable consumer, the patient. This report received from a 63-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6200) via an unspecified route of administration in left arm on 11Mar2021 (at the age of 63-years-old) at 11:30 as a single dose for COVID-19 immunisation. The medical history reported that the patient had two ablations, otherwise regular exercise, active living style. The patient had not received any medications within two weeks of vaccine. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination the patient was not diagnosed with COVID-19. The patient had not been tested positive for COVID-19 since having the vaccine. On 13Mar2021, the patient experienced vaccination site pain, upper body muscle crumps mostly around neck area, swollen lymph nodes, severe constant headaches with neck pain, tiredness, felling unwell, dizziness and weakness and any body movement causing neck to head pain. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as results of events and included the treatment with naproxen 500mg, baclofen 10mg. The clinical outcome of the events vaccination site pain, upper body muscle crumps mostly around neck area, swollen lymph nodes, severe constant headaches with neck pain, tiredness, felling unwell, dizziness and weakness and any body movement causing neck to head pain were not resolved at the time of this report. No follow-up attempts are needed. No further information is expected.

- Severe lethargy - Chills - Dehydration - Limited torso flexibility - Rash - Swollen back of neck - Weight loss (20 pounds)

Started with chills/fever spike, loss of touch/feeling in extremities (fingers, toes). These started approx 12 hours after injection. Has now been 2 and a half months. Have issues with anxiety, muscle aches, weakness in legs. Experienced pulled tendon in left arm accompanied by extreme bruising down arm. Developed cancerous lesion on lower lip (squamous cell carcinoma).

Felt like punched in arm; Some soreness and some stiffness at the injection site; stiffness at injection site; This is a spontaneous report from a contactable consumer, the patient. A 63-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 on 24Mar2021 at 16:30 (at the age of 63-year-old), as a single dose for COVID-19 immunisation. Medical history included mild obstructive sleep apnea. Concomitant medication included pravastatin (MANUFACTURER UNKNOWN) 40 mg and omeprazole (MANUFACTURER UNKNOWN) 20 mg daily; both for an unknown indication from unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. On 24Mar2021 at 19:00, the patient experienced like punched in arm, some soreness and some stiffness at injection site. The patient used an ice pack and once taken 800 mg ibuprofen helped reduce this no worse than mild pain or soreness. Moving left arm overhead with a back-and-forth motion also provided relief. 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 felt like punched in arm, sore injection site and injection site stiffness were recovering at the time of this report. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

shingles; This is a spontaneous report from a contactable consumer (patient). A 63-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), intramuscular, administered in the left arm on 19Apr2021 13:30 (batch/lot number ER8729 and expiry date unknown) at 63 years of age as dose 2, single for covid-19 immunization administered in a clinic ( health clinic/ facility). The patient medical history and concomitant medications were none. The patient previously received dose 1 of BNT162B2, intramuscular, administered in the left arm on 29Mar2021 13:00 (batch/lot number ER8732) at 63 years of age for covid-19 immunization. On 16May2021, the patient experienced shingles. The patient informed that he didn't know if the company has any history of this, but he got his second COVID-19 shot and he got shingles after that. The event required visit to emergency room. The event was reported serious as an important medical event. The patient received treatment of acyclovir, gabapentin due to the event. The outcome of the event was not recovered. Follow-up attempts are completed. No further information is expected.

developed severe case of dermatitis on extremities and torso. nothing changed in routines or environment. doctor can't explain why it has occurred. symptome are abating now

Intense Intense pain at site immediately.; then about 18 hours later a severe stinging (like a bee sting) on the instep of left foot that is till happening. Does not respond to Motrin; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: UNKNOWN) in the left arm on 01Apr2021 at 09:00 (at the age of 63-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. Concomitant medications included losartan potassium (LOSARTIN) for unknown indication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: UNKNOWN) in the left arm on 11Mar2021 at 09:00 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID-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 01Apr2021 at 09:00, the patient experienced Intense pain at site immediately then about 18 hours later a severe stinging (like a bee sting) on the instep of left foot that is till happening. Does not respond to Motrin. The patient received ibuprofen (MOTRIN) as treatment for the reported events. The adverse event 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 vaccination site pain and pain in extremity was not recovered at the time of this report. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

10 days after initial vaccine, broke out in raised rash at elbow which then progressed to other arm also at elbow area. Rash progessed slowly down the arm to the wrists on both sides. Rash slowly resolved by the time I received 2nd dose of COVID vaccine. Approximately, 10 days after second vaccine, the rash return but more significantly and became a generalized raised rash covering most of my body from scalp down to toes. After 6 months, rash started to resolve slowly, but now my skin is intolerant of any adhesive dressings which causes welts around the edges of the dressing. I use adhesive drsng for insulin infusion sets and continuous blood glucose monitoring. I am no longer able to tolerate an infusion set longer than 24 hrs, and not able to use CGM sensor for the same reasons.

EE had COVID vaccine at approx 10:20a today. EE reports to EH with rash on abd. and arms. Denies SOB, facial swelling, o2 sats 96%, P 72.BP 116/62. 25 mg Benadryl given at 1350. Released from EH at 3p, EE cont. to deny SOB or other sx. Rash ?less hot?. EE to report to UC or ER if sx worsen.

fever; chills; nausea; headache; fatigue; had a local reaction of a "patch of inflammation, redness, burning sensation- similar to a 2nd degree burn."; had a local reaction of a "patch of inflammation, redness, burning sensation- similar to a 2nd degree burn."; had a local reaction of a "patch of inflammation, redness, burning sensation- similar to a 2nd degree burn."; This is a spontaneous report from a contactable physician (patient). A 64-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot/batch number not reported), via an unspecified route of administration on 19Dec2020 at a single dose for Covid-19 immunization. Medical history included pneumonia from 03Aug2020 to 08Aug2020. Concomitant medications were not reported. Patient had the first COVID-19 vaccine dose on 19Dec2020. Patient said he had a "pretty strong reaction" of fever, chills, nausea, headache, fatigue in Dec2020. Felt ill until day 2, started feeling better on day 3. Patient also had a local reaction of a "patch of inflammation, redness, burning sensation- similar to a 2nd degree burn" in Dec2020. Patient also mentioned he had his blood work last 30Dec2020 and confirmed he has IgG antibodies. Patient then asked "I want to get the second dose, is it okay to get the vaccine?" The outcome of the events 'fever, chills, nausea, headache, fatigue' was recovering while unknown for the other events. Information about Lot/Batch number has been requested.

Myalgia, Diarrhea, pain at injection site Narrative: Myalgia and inection site pain/myalgia and diarrhea by 9pm on date of injection 12/29/20. Myalgias continued for 2 days and resolved by day 3.

shoulder turned black/Shoulder blade and whole shoulder turned black; blistered; This is a spontaneous report from a contactable consumer (patient). A 64-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in deltoid left on 04Jan2021 at single dose for COVID-19 immunization. There were no medical history or concomitant medications. The patient experienced his whole shoulder turned black/ shoulder blade and whole shoulder turned black and is blistering on 05Jan2021 12:00. Caller also took the shingles shot 3 weeks prior to getting the COVID-19 vaccine. Confirmed no testing was done. When he went to the doctor they just peeled the scab off, placed ointment on, bandaged him up. He was also provided with a prescription. The outcome of the events was unknown. Information about Lot/Batch number has been requested.

Headache, Myalgia, injection site pain Narrative: Side effects began the day after Injection: site pain, significant myalgia and arthralgia, could not walk his dogs, rigors without fever, chills-has to take Acetaminophen every 6 hours, frontal headache. States fatigue is "disabling" Has had to take time off of work.

Facial tingling, itching and redness; Facial tingling, itching and redness; Facial tingling, itching and redness; This is a spontaneous report from a contactable nurse (patient). A 64-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), intramuscular in the right arm on 08Jan2021 10:00 at a single dose for COVID-19 immunization. The patient's medical history included mild adrenal insufficiency. Concomitant medication included hydrocortisone to 06Jan2021. The patient previously took lidocaine and experienced allergies to lidocaine and first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. The patient experienced facial tingling, itching and redness on 08Jan2021 10:45. Therapeutic measures were taken as a result of facial tingling, itching and redness and included treatment with self administered chlorpheniramine 12 mg. Outcome of the events was recovered on Jan2021. The events were considered non-serious by the reporter. Information on the lot/batch number has been requested.

I did my Injection Friday 1/15/2021 at 09:00 PM and woke up Saturday feeling unwell, chills and muscle pain all day. Sunday 1/17/2021 I awoke at 6:00 AM with my Right ear swollen at least three times normal size. The ear has visable sores and is extruding a clear liquid all day Sunday 1/17/2021 and today Monday 1/18/2021. I made an appointment for 4:30 PM today with NP

Moderate left arm pain at injection site. Diffuse muscle and joint aches, migratory lasting 36 hours. Headaches,24 hours Increased nasal congestion 24 hours Moderate fatigue 36 hours Insomnia 2 nights Chills for 4 hours beginning 30 hours after injection Low grade fever beginning same time as chills and lasting for next 12 hours terminating with sweats

Hives; This is a spontaneous report from a contactable consumer (patient). A 64-years-old male patient received second dose of bnt162b2 (BNT162B2, lot number: EL3249), via an unspecified route of administration on 16Jan2021 07:00 on Left upper Arm at SINGLE DOSE for covid-19 immunisation. Medical history included Blood pressure, High cholesterol, Asthma. Concomitant medication included losartan for high cholesterol, montelukast for asthma, valsartan for blood pressure. The patient woke-up at 5 AM with hives on 17Jan2021. The event was treated with Benadryl and have the hydrocortisone cream that went away and came back, that went away and came back and came back again in the morning of reporting date, so the consumer didn't know it's related. Investigation Assessment: No. The event outcome was not recovered.

He states that he received the vaccine on 2/20 and three days later developed a red rash on his chest and back that has not completely gone away. He states that on 1/25 he developed nausea and vomiting to the extent that he missed work both of those days - this has resolved.

Started sneezing with watery itchy eyes 4 days after injection. On day 4 woke up with hives on back that has spread to right arm. Rash is small and not raised, but is quite itchy.

Excruciating right glenohumeral (shoulder) joint pain -- no muscle pain, along with greatly restricted range of motion. It is apparent that the hypodermic needle punctured the rotator cuff and bottomed out onto bone ("twinge" felt upon point of full insertion and upon injection). The injection site was too high on the upper arm (just below the subacromial space - I have photos with the location marked). Additionally, the 1-1/2 inch long hypodermic needle was fully inserted without manipulating the muscle to raise its height. The above was confirmed by examination by Doctor. Pain and diminished range of motion still evident, but somewhat subsiding as of 11:00PM 2-15-2021 (55 hours after onset).

Body aches, fever, chills, joint swelling gradually worsened until had to miss work on 2/9/21. Symptoms persisting. Sudden onset dermatomal type skin rash 2/12/21. As of 2/16/21, starting to resolve. Diagnosed as atypical shingles because other than rash, no pain or itching associated with this.

Immediate pain in left arm day of vaccination. Next day pain radiating down left day. Worsting day bay day. 12 days later, unable to walk. Went to hospital 2/15/2021, for inability to walk and radiating pain down both legs. At that time, found out that i possibly diabetic in addition to the pain.

a genitourinary infection (UTI)/diagnosed with a gram negative urinary tract infection; iron level was low at 21. He said a normal iron level for a male is 35; couldn't walk afterwards; Tiredness; another soft tissue injury; Headache; left eye was totally blurry/ one eye blurriness; has severe eye dryness; Injection site pain; Injection site redness; injection site puffiness; stated he noticed at around 2:30PM-3:00PM he had a rash on his hip and back; shingles/ shingles pain; a fever of 100.4 Degree F/Fever; This is a spontaneous report from a contactable pharmacist (patient) reported similar events for two patients. This is the first of two reports. A 64-year-old male patient receive first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246), at same age intramuscular in arm left on 16Jan2021 11:00 at single dose for COVID-19 immunization. Medical history included fallen at work and landed on his left side, hitting his head and left knee, a knot on the left side of his head, bleeding from above his left eyebrow, had a left black eye, all on Nov2020, subarachnoid hemorrhage, cataract surgery, using crutches when he walks, in the hospital from Nov2020 to 17Nov2020, pacemaker implanted while he was in the hospital on Nov2020, he couldn't walk on 19Nov2020, 6 stents, 3 cardiac stents on Oct2020, and chicken pox as a young adult. Concomitant medication included aspirin [acetylsalicylic acid], clopidogrel bisulfate (PLAVIX) from unspecified date to 27Jan2021 for 6 stents, paracetamol (TYLENOL, 500 mg, caplets, NDC Number: 5058044936, Lot Number: SJA066 and Expiration Date: Jul2024). The patient said he received his first COVID-19 Vaccine dose on 16Jan2021. He said at the time he pre-medicated with 2 paracetamol. He said he had read afterwards that it is not recommended to pre-medicate with Tylenol before receiving the COVID-19 Vaccine. On 24Jan2021 he developed a fever of 100.4 Degree F (body temperature). He stated his fever was 8 days after receiving his first COVID-19 Vaccine dose. On 27Jan2021, he was urinating blood/blood clots and was admitted to the hospital and treated for a UTI. He was diagnosed with a genitourinary infection (UTI). He clarified on the morning of 27Jan2021 his urine looked darker than normal. He said he went to physical therapy (PT) on 27Jan2021. He said when he came back from PT, and went to the bathroom, there was blood and blood clots in his urine. He said he called his urologist, and his urologist saw him on 27Jan2021. He said his urologist took a urine sample, and his urine sample was clear and negative for nitrites. He clarified his urologist did a digital prostate exam, and his prostate was fine. He said his urologist wanted him to make an appointment for a cystoscopy, and a CAT scan of his abdomen and pelvis. He said after he got home from the urologist, he went to the bathroom, and again had blood and blood clots in his urine. He went to emergency room. While he was in the Emergency Room, he was set-up on CBI (Continuous Bladder Irrigation). He said the urologist did not seem concerned about the amount of blood in his urine. He clarified he was admitted to the hospital, and had in place for approximately 16 hours. Next day (28Jan2021) he was diagnosed with a gram negative urinary tract infection. He said he was given a daily dose of IV Ceftriaxone 1gram on 29Jan2021 and 30Jan2021. He said he was also given a daily dose on 29Jan2021 and 30Jan2021 of IV Ferrlecit 125mg because his iron level was low at 21. He said a normal iron level for a male is 35. On 31Jan2021 he had injection site pain in his left arm, he said the COVID-19 Vaccine injection site was red and puffy. He said the COVID-19 Vaccine injection site pain, redness, and puffiness resolved on the same day, 31Jan2021. He said his second COVID-19 Vaccine dose was given in the same arm (left) on 06 Feb2021. He stated he asked that the second COVID-19 Vaccine dose be given in the same arm (left) because his left arm is his non-dominant arm. He was discharged from the hospital on 30Jan2021, and was given a prescription to take 1 Levaquin 250mg orally for 3 days starting on 31Jan2021. He said the Levaquin 250mg was dispensed in a pharmacy bottle, and did not have the NDC, Lot, and Expiration Date. He said he was also prescribed oral Feosol 325mg, twice a day, starting on 31Jan2021. He provided the Feosol 325mg, NDC Number: 12451-10-17 (unsure if he provided the correct NDC), Lot Number: 201167, and Expiration Date: Jul2022. At around 2:30-3:00PM on 31Jan2021, he developed a rash on his hip and back, saying the hip and back rash were along the same pathway. He said he spoke to a PA (physician assistant) about his rash. He said on 31Jan2021 he had taken 1 oral dose of the Levaquin 250mg. He said the PA discontinued the oral Levaquin 250mg, and changed his prescription to Macrobid 100mg, twice a day, for 5 days. He said he started the Macrobid 100mg, twice a day, on Monday, 01Feb2021. He said he completed the Macrobid 100mg prescription on Sunday, 07Feb2021, and did not have the Macrobid 100mg NDC, Lot and Expiration Date. He clarified his rash was raised, oozy, and looked weird, like a pimple that came to head. He said he spoke to his dermatologist on a video call Sunday, 31Jan2021. He said his dermatologist told him he had shingles and prescribed Valtrex 1gram, three times a day, for 7-10 days. He stated the Valtrex 1gram was dispensed in a pharmacy bottle. He said he took his first Valtrex 1gram dose on Sunday evening, 31Jan2021, and was still taking the Valtrex 1gram as of today (08Feb2021). He had an appointment to see his dermatologist in person on Wednesday, 03Feb2021, but woke up with a wicked headache that morning, so he took paracetamol and went back to sleep. He said when he woke, he still had headache, and his left eye was totally blurry. He said back in Nov2020 he had fallen at work and landed on his left side, hitting his head and left knee. He said his fall left him with a knot on the left side of his head, and he had bleeding from above his left eyebrow, and had a left black eye. He said he also had a subarachnoid hemorrhage. He said he had a CT scan of his head that showed the subarachnoid hemorrhage was contained, so the doctors wanted to just monitor him. He said he was on Effient at the time and the doctors changed him to Plavix. He said he also was taking Aspirin 81mg. He said he was taken off of Plavix on 27Jan2021 when he was admitted to the hospital for having blood and blood clots in his urine. He said he continues to take the Aspirin 81mg daily. He clarified he has been on compensation since his fall in Nov2020. He said he also had cataract surgery 2 years ago. He said he immediately called his eye doctor, and then went to the hospital Emergency Room because he thought he had a stroke. He said the Emergency room did a CAT scan and CTA of his head, which were both normal. He said a neurologist saw him in the Emergency Room, and said since it was a headache with one eye blurriness, he should see his eye doctor. He said the neurologist told him if he had a headache and both eyes were blurry, it would more likely have been a stroke. He stated when he was discharged from the Emergency Room on 03Feb2020, he went directly to his eye doctor. He said his eye doctor did several tests: field of vision, a sonogram, pictures of his left eye, and a dilation of his eyes. He said he had an eye test where he looked at a half circle and clicked a counter when he saw dots, and another eye test where he stared at something that looked like a hot air balloon, while the eye doctor took measurements. He said the eye doctor also measured his eye pressure, which was normal. He said he was at his eye doctor's office for a good couple of hours. He said his eye doctor told him that he has little white dots on the background area of his eyes that indicates he has severe eye dryness. He said his left eye is much worse than right eye. He said his eye doctor asked him if he took Crack, or Cocaine, or any kind of opioids in the last few weeks. He said he told his doctor he took 1 dose of an opioid on 31Jan2021 because of the shingles pain. He clarified he had a Percocet prescription leftover from his hospitalization in Nov2020. He said he took another dose of the Percocet the week before 31Jan2021 for pain in his knee from the fall he had in Nov2020. He said his eye doctor told him his dry eyes could be caused by the Percocet. He said his eye doctor prescribed lubricating eye drops (Refresh Optive Mega 3, UPC Number: 0023577330, Lot Number: T095, and Expiration Date: Aug2022), that he is to use in both eyes every hour, and an eye ointment in his left eye only at bedtime. He had been using crutches when he walks because of the problem with his right knee since he fell in Nov2020. He said on 06Feb2021, he took a shower, and when he went to get out of the shower, his right leg gave out. He said he didn't fall, but he couldn't walk afterwards. He said he went to the Emergency Room on 06Feb2021, and an x-ray and sonogram were done of his right knee. He said he was told he had another soft tissue injury like he had when he fell back in Nov2020. He said he was given a leg immobilizer to use. He said when he first fell in Nov2020, he originally fell on his left knee. He said he has had PT since being discharged from the hospital on 17Nov2020. He said he also had a pacemaker implanted while he was in the hospital in Nov2020. He said after his discharge from the hospital on 17Nov2020, he went to take shower at home on 18Nov2020 and his left knee gave out. He said he was able to lower himself to the floor in the shower stall, but he couldn't get out of the shower stall. He said he was left sitting on his left leg and he couldn't use his right leg. He said he finally got himself to bed, and iced his right knee because he sat on it for over an hour. He said the next day (19Nov2020), he couldn't walk and had to have an ambulance take him to Emergency Room. He said he hasn't had PT since 27Jan2021, and needs clearance from his doctor before he can restart PT. He said he has been without PT for 2 weeks now. He said on 06Feb2021 he was unable to get a MRI on his knee because he had too much swelling that would have made the MRI imaging cloudy. On 06Feb2021 he was due for his second COVID-19 Vaccine, so before he was discharged from the Emergency Room he was given his second COVID-19 Vaccine dose. He was using the Refresh Optive Mega 3 eye drops constantly now. He said he had no fever, but is more tired than in the past. He said the last couple of days he can sleep for hours, and wake up and feel like he can go right back to sleep. He said he and his cardiologist are concerned because since 27Jan2021, he has only been on Aspirin 81mg. He said he has 3 cardiac stents since Oct2020, and should be on dual therapy. He said he had a CT of his abdomen and pelvis while he was in the hospital. He said he has been off of Plavix since 27Jan2021, and can restart the Plavix until he has a cystoscopy. He wants to know if UTIs in men are common after getting the COVID-19 Vaccine, so he can decide if he should cancel the cystoscopy and restart his Plavix. The second COVID-19 Vaccine Lot number as EL9261 or EI9261. He stated the vaccine lot number was handwritten on his COVID-19 Vaccine immunization card and was difficult to read the handwritten vaccine lot number. The patient underwent lab tests and procedures which included bacterial sepsis: gram negative urinary tract infection on 28Jan2021. Clarified he had no pain, burning, or urgency with the UTI. He said he was told by the hospital he had gram negative rods in his urine, when he was started on the IV Ceftriaxone on 29Jan2021. He stated he has never had a UTI before. Clarified his body temperature is rarely 98.6 degrees, and is normally 98.2 degrees and he had never had shingles before. He said he had chicken pox as a young adult, and he only had 1 spot of chicken pox. He had never had dry eyes before. Reporter seriousness for fever, UTI, injection site pain, injection site redness, injection site puffiness, rash, shingles were medically significant. For other events were unspecified. The outcome of event injection site pain, injection site redness, injection site puffiness was recovered on 31Jan2021, dry eye, tiredness was not recovered, while the outcomes of other events were unknown.; Sender's Comments: Based on the temporal association and the known possible local reaction, a possible contributory role of BNT162B2 to the development of injection site pain, redness, and puffiness cannot be excluded. The other events are considered as due to underlying or intercurrent conditions and unrelated to the use of BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021134924 same reporter/drug, different patient, similar event

Developed shingles around right eye. Symptoms began 4 days post-injection. I had received the Shingrix vaccine x 2 in 2018. I am currently treated by my PCP and ophthalmologist with valacyclovir and gabapentin.

102 fever, swollen lymph nodes underarm ( side of injection), tenderness of swollen area. Skin rash

Hives on upper body - particularly shoulders, chest, back. Severe itching. Prescribed Zyirtce / cetirizine 10 mg in morning; Pepcid or famotidine 20 mg twice daily; Benadryl or diphenhydramine 25 mg nightly (am still taking prescription - one month after injection - as slight symptoms still exist.

Rash all over his body; rash which is red patchy tiny blistery things; rash which is red patchy tiny blistery things; pain of the rash and blisters; Itching; Shoulder pain; This is a spontaneous report from a contactable consumer (patient). A 64-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number: EH9899) solution for injection, via an unspecified route of administration on 21Jan2021 at a single dose for Covid-19 immunization. Medical history was reported as none. There were no concomitant medications. The patient experienced shoulder pain on 22Jan2021; itching started on 23Jan2021; rash all over his body which has worsened, rash which was red patchy tiny blistery things on 24Jan2021. Patient further reported that he had a rash over his entire body. It started as an itch on his legs which developed into more itching which turned into a rash which was red patchy tiny blistery things. Now it was on his arms, back, belly, neck, and legs. He had shoulder pain and it was hurting the day after he got the vaccine on Friday 22Jan2021. Rash started on Sunday 24Jan2021, it was like a chicken pox type rash. It was like red dots that become sensitive and look slightly blistered. Shoulder pain: this was nothing compared to the pain of the rash and blisters (24Jan2021). He had taken off the bandage and was sore. He was not even sure if he was still sore or not because he was only paying attention to everything else. It was overwhelming. Treatment: He called his doctors and they said that he should use Calamine lotion as a temporary soother for itch and rashes. They also told him to take Benadryl and his doctor prescribed Prednisone. Outcome of the event shoulder pain was unknown while the other events was not recovered. No follow-up activities are needed. No further information is expected.

Within 5 minutes felt flushed , high blood pressure and heart rate, body trembling, red skin rashes.

he has cold like symptoms; Stuffed up nose; doesn't feel really good; pain in the site area; slept a lot and was tired; slept a lot and was tired; his stomach is nauseous and queasy; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported that a 64-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration in Jan2021 (also reported as "around 19Jan2021" or "19Jan2021 or 20Jan2021", pending clarification) at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient got his first COVID dose around 19Jan2021 (also reported as "19Jan2021 or 20Jan2021") and now he has cold like symptoms. Stuffed up nose, doesn't feel really good and wanted to know if this part of the COVID vaccine. On the first day, he had pain in the site area, slept a lot and was tired. It has been 10 days since the shot and he had symptoms of a cold and his stomach was nauseous and queasy (also reported as squeezy). The reporter wanted to know if this was a part of the side effects or does she need to call his primary care. She was told about symptoms to watch for within the first seven days and this was well beyond the seven days. The outcome of the events was unknown. Information on the lot/batch number has been requested.

Extreme pain in injection site. Treated with ice and one Tylenol tablet. Pain mostly gone by next morning.

The day after receiving the COVID injection I started experiencing shooting pain and tingling in left arm, then a day or two later experienced a burning sensation in lower left arm. The pain in left arm significantly increased over the next few days and on Friday evening developed blisters in the palm of left hand. On Saturday, March 6, 2020 was diagnosed with Shingles potentially caused from the COVID vaccine.

Moderate to severe injection site pain starting 12 hours after vaccine resolved after being present another 12 hours

Patient called to inform me that she had a reaction to vaccine. Vaccinated on 3/5/21 with Pfizer #2. Reported arm swelling, redness below the site of administration. Reports the redness and swelling progressed and raised up to the size of an "orange" on 3/8/21. Pt sought medical treatment at local emergency room on 3/8/21 and was diagnosed with cellulitis. Rcvd ABX for treatment and pt reports treatment is responding well. Pt also reports she experienced "welts" and "redness" "rash-like" to the face and neck after vaccination.

An hour after the vaccination I started getting a rash and itching on my body for more than a week and it only went away with benadryl

Minor soreness in left shoulder around site of injection. Began today approximately 18 hours after injection.

Very mild allergic reaction. Slight swelling of lips, redness of palms. Symptoms dissipated completely within six hours.

Arm soreness at injection site Temp 102 F for 48 hrs Severe shaking chills, rigors for 48 hrs Headache 72 hrs Severe myalgias for 72 hrs Joint pain 72 hrs Sweats, particularly at night for 72 hrs Fatigue for 96 hrs Took multiple doses of Tylenol 1000mg over course of 72 hrs.

Terrible cramps diarrhea nausea vomiting constipation a high fever of a 103 or more Muscle aches sore skin joint ache Worse than the flu

I received the vaccine on Friday the 12th. On Sunday the 14th I noticed that I had a sort of "wound" in my left lower back. It was causing me some pain when the tip of my backpack touched the area. On Tuesday the 16th I visited the doctor who gave me the news that I had shingles. He discovered that it was actually spreading a little bit more around the original that I saw on Sunday. I'm already on medication for that.

Had minor pain at injection site beginning 4 hrs after ijection, resolved after 24 hrs. No other side effects until 7 days late (19 Mar). Moderate chills, moderate fatigue, moderate headache began 7 days after first injection, persisting with little change now 80 hrs after onset. One instance diarrhea 60 hrs after first injection. No fever. No joint pain or swelling. Have consulted PC nurse who advises I report this, and self-quarantine while await PCR results. I will report to ER if symptoms significantly worsen, otherwise will check back with PC physician Monday 22 Mar.

Hives and rashes on both arms, inner and outer side of both thighs, torso, underarm, both shoulders, lower and upper back.

Injection site soreness x 3 days, Myalgias and fever (99.2 -100) for three-four days, headaches, fatigue, arthralgias.

Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: initial dizziness, loss of consiousness for roughly 30-60 seconds, body rigidity before waking up-Severe, Systemic: Flushed / Sweating-Mild, Systemic: Weakness-Medium, Additional Details: 4-5 minutes after vaccinating patient he reported feeling dizzy, when accessing patient he became unresponsive and breathing became louder, he became pale and lost consciousness. 911 was called. His face began turning red and with the help of 2 individuals we lowered him to the floor, his arms became rigid for abotu 5 seconds, and upon trying to wake him/checking for vital signs, he came to and was aware of where he was and that he had just got a vaccine. he did not recall the event post dizzine

Please include ?Pfizer-BioNTech COVID-19 Vaccine EUA? in the first line of box #18 of the report form. Mild pain around injection site (dose #1 & dose #2) and mild diarrhea approximately 14 hours after dose #2 injection only. Diarrhea persisted approximately 30 hours.

day after vacc #1 Pt. developed Atrial flutter, hx Afib for 20 years, over last1-2 years no problems after ablation, only one episode of Atrial flutter during suspected Covid +in Aug, 2020 Current Atrial flutter event required conversion, 4 days later develped slight rash around pelvic area, very local read article it is nano partilcles of polyethelene glycol causing issue. not questioning taking second vacc.

Felt fine initially. About 4 hours later got very light-headed and fainted while walking to rest room - resulted in 7 stitches (head laceration) and 2 broken ribs from fall. A "vaccident". I was taken to the ER for treatment and spent 2 nights in the hospital. Over the next 8 or so hours I experienced fatigue, chills/shakes, nausea (threw up 3-4 times), and fainted a second time (while lying down).

Got a rash and bumps all over body to include a shingles breakout on left leg. Still have a rash and shingles 12 days later. Also seem to have slight headaches throughout the day

broke out in hives 7 days later totally covering body. severe itching and controlled with Benedryl. On day two, lower lip swelled. No problems with breathing.

63yoM with PMH Anxiety, Depression, GERD, Arthritis here for evaluation of rash x 2 days. Pruitic in some spots. Started on L wrist yesterday. Awoke with red spots on face today. Got 2nd COVID19 vaccine (pfizer, with Norton) 48 hours ago. Called hotline and they advised coming for evaluation. Has applied no therapies. Took a single benadryl last night for pruritis. Denies chest pain, dyspnea, wheezing, dizziness. Did yard work 4 days ago and history of contact derm to plants, otherwise no prior history of rash like this.

Severe Headache, Mild Fever (99.2 F), Body Aches, Chills, minor red rash at injection site, pain in Rt arm at injection site. Started around 3 pm on 3/28/21 and progressed until oral administration of 200 mg of Ibuprofen along with oral administration of 500 mg of Acetaminophen at 4 pm. Another 500 mg of Acetaminophen administered at 8 pm.

Anaphylaxis, dizziness, flush, itching, nausea, headache, heart racing, difficulty breathing. Gave me EpiPen. Was in ER for 4 hours after. Took antihistamine every 6 hours for 3 days.

After a few hours, pain at vaccination site. Not very painful, though. Sore and red throat on the left side. Shot was given in my left arm.

Had slightly red,slightly itchy,sore area at the injection site about as big around as a silver dollar.Using my other hand to rub that spot,I could feel a lump deep under the skin,about the same size.Those symptoms seemed to worsen over about 3days then started tapering off.On the morning of day 7 (today) the redness & soreness has seemingly diminished and only a very slight noticeable lump remains & I expect that will soon go away also.Was only annoying & not bad enough to cause me any alarm.Friends told me it was"Covid Arm"(vaccine arm), & it was happening in some patients, esp.those that had already recovered from the virus.I had tested positive for Covid-19 in early December and recovered about 3 wks later.

rash developed on the inner bicep of the OPPOSITE arm of the injection. Treated with cream. Rash was gone 3 days later.

Patient received dose 1 of the COVID vaccine (Lot EW0150, exp 7/2021) at 11am. At 1106 he reported to PHN that he had itiching at he injection site stating it felt similar to a mosquito bite. EMT came over to assist PHN with the assessment. At 1112, vital signs: blood pressure 154/102, O2 98%, pulse 67, respiration 18. Medication includes Vimpat 200mg daily. Medical condition includes epilepsy. No known allergies. At 1120, PHN offered Benadryl but patient declined. Patient reported his symptoms had resolved. Vital signs at 1120: blood pressure 164/106, pulse 74, O2 98%, respirations 16. Patient reported that his blood pressure has been running 160s/100s and he was seen by his neurologist recently. PHN requested that patient stay until 30min after symptoms first noted, patient reported he wanted to leave. PHN advised patient to notify provider and when to call ED.

a few hours after getting vaccinated, I got a HUGE migraine headache, nausea and later a rash on my face. I couldn't lay down, had to keep my head elevated. It last almost two day. I felt brain fog for 4-5 days.

Initial shot had no pain on day one. Sore Arm at injection site on day 2 & 3. Feeling chills (feeling cold) in 75 degree weather with blankets on. Night sweats and chills in bed. Insomnia has lasted 3 weeks (sleep about 4-4.5 hours and CANNOT go back to sleep). ZERO History of insomnia before vaccine.

1 week after dose 1 of Pfizer Covid-1 vaccine, I developed a case of shingles. I had chicken pox when I was young, but had not experienced any symptoms of it as an adult until after the Pfizer shot.

Developed sroeness at injection site; nocturnal nasal congestion; This is a spontaneous report from a contactable pharmacist. A 64-year-old male patient received bnt162b2 (BNT162B2, solution for injection, Lot #;EL3247), dose 1 via an unspecified route of administration, administered in Arm Right on 17Feb2021 11:45 as SINGLE DOSE for covid-19 immunisation. Medical history included blood cholesterol increased from an unknown date and unknown if ongoing, vasomotor rhinitis from an unknown date and unknown if ongoing, benign prostatic hyperplasia from an unknown date and unknown if ongoing, dry eye from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On 17Feb2021 18:30, the patient experienced developed sroeness at injection site, nocturnal nasal congestion. The action taken in response to the event for bnt162b2 was not applicable. Therapeutic measures were taken as a result of developed sroeness at injection site (vaccination site pain), nocturnal nasal congestion (nasal congestion). The outcome of the event was recovering.

Patient stated he had a red face and it was puffy about 1.5 hours after vaccination. Patient was able to take some Benadryl and 2nd doses was fine.

Got the vaccine, he was fine while he was there, the following day his arm starting itching, and then had a big rash about 3" x 3" immediately after the vaccine. The swelling did not go down, he went to see his doctor and she gave him a steroid shot and some Pepcid, Zybek OTC to take. These are still itchy as of 4/7/21, but trying to dry up and scaly. He has been putting ointment and peroxide on the area.

This is a spontaneous report from a contactable consumer. A 64-year-old male patient received the second dose of the BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number unknown, Expiration Date: unknown),via an unspecified route of administration on Arm Right On 02Feb2021 01:00 at single dose for COVID-19 immunization. The patient historic vaccine include second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number unknown, Expiration Date: unknown), via an unspecified route of administration, On Jan2021at single dose for COVID-19 immunization. concomitant medication was not reported. On 04Feb2021 patient experienced swelling under armpit a little larger than an egg, fluid went into his chest and back, red blotches on chest and back, event recovered on 06Feb2021. On 07Feb2021 patient experienced swelling in face primarily around the eyes(ongoing), face was as red as a beet as if he had a sunburn (ongoing). Patient took treatment Benadryl. The first dose was 21 days exactly prior to the second Vaccination. Vaccination Facility Type at Hospital. The outcome of swelling under armpit a little larger than an egg, fluid went into his chest and back, red blotches on chest and back, event was recovered on 06Feb2021 and red as a beet as if he had a sunburn, event eye swelling, erythema Recovering. Information on the lot/batch number has been requested.

Soreness in Right Shoulder at site of vaccine. Soreness all over body. Fatigue and very tired after 8 hours of sleep.

CLIENT REPORTS THAT HE WOKE UP 4/4/21 WITH PAIN IN HIS RIGHT KNEE AND SWELLING IN HIS RIGHT CALF, WHICH HAS INCREASED FROM HIS RIGHT KNEE DOWN TO THIS DAY. HE ALSO HAS NOTICED IT IS WARM TO THE TOUCH TODAY. CLIENT CALLED HEALTH DEPT TODAY TO REPORT THIS SYMPTOMS. PUBLIC HEALTH NURSE CALLED CLIENT FOR INFORMATIION AND ADVISED HIM TO SEE A MEDICAL PROVIDER TODAY REGARDING HIS SWOLLEN AND PAINFUL R LEG/CALF. CLIENT AGREEABLE. CLIENT STATES HE HAS APPOINTMENT TODAY AT 2:45 WITH A PROVIDER.

left shoulder was still sore where he got the shot; Headache; This is a spontaneous report received from a contactable consumer, the patient. A 64-years-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE),via an unspecified route of administration in the left arm on 09Mar2021 11:00 (Batch/Lot Number: unknown; expiration date: unknown; NDC number: unknown) (at the age of 64-years-old) as a single dose for COVID-19 immunisation. Medical history included the patient had occasionally headaches and took acetaminophen, aspirin and caffeine off and on as needed for headaches. Concomitant medications were not reported. On 09Mar2021, shortly after when he was leaving and driving, he started getting a headache and he took two acetaminophen, aspirin and caffeine (EXCEDRIN) at lunch time. His head started hurting about half an hour after the vaccination. The headache kind of went away after the lunch. On an unspecified date, the patient stated that left shoulder was still sore where he got the shot. The outcome of event, headache was recovered on 09Mar2021 as the headache was gone and the outcome of event, left shoulder was still sore where he got the shot was not recovered. The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow up.

Splotchy noncontiguous light red rash located in the inside of both legs starting on the lower end of the calf muscle at roughly the same distance from the ankle, and progress up to the inside of the Knee. The rash does not hurt or itch. The rash has been present for about 3 weeks, but in the last few days I've noticed that the rash has now slowly progressed past the knee now in the inside of the lower left thigh. I'm also seeing a more recent light rash forming above the right knee on the lower thigh. (NOTE EXTRA INFO IN BOX 9, and 12: Erectile Dysfunction & Sildenafil - 1 tab 50 mg is taken as needed. Last does were March 28, and March 29th.

Hives and rashes on both arms, inner and outer side of both thighs, torso, underarm, both shoulders, lower and upper back.

Noticed around 13:30 hours: Swelling and moderate pain around injection site, slight headache; Noticed around 14:30 hours: numbness in forehead, nose & cheeks; drowsiness; Noticed around 16:00 hours: pounding headache requiring ingestion of Tylenol, fatigue; Noticed around 18:30 hours: aches & pain in joints, primarily ankles, knees, fingers, wrists, elbows, and shoulders; Noticed around 03:30 following morning: cramps in right calf muscle lasting for approximately two (2) minutes. As of 04/16/2021 at around 10:54: slight headache, some fatigue, aches & pain in joints still exist but diminishing with worst pain area in knees, elbows, and wrists.

Two reactions, one severe, one moderate. Moderate: My arm starting hurting three days after the first shot, a dull pain at the site of the jab. The dull pain has not gone away. I can feel it right now as I type this. Severe: One week after the first shot, my varicose vein problems re-emerged. I had vein surgery in 2018, and my problems vanished until the first shot. My calf muscle swelled and became very painful; my lower leg was covered with black and blue bruises; my varicose veins reappeared. These problems diminished slowly throughout February. I saw a specialist at the Vein Clinic in March, who determined that I needed additional surgery this summer. My leg has almost returned to normal, but I have intermittent heaviness in the calf muscle and pain in the quads, like a weaker version of what I had before the first vein surgery in 2018. Additional comments: I had a bout of powerful fatigue following the first shot. I slept 14 hours straight the day after getting it. For the second shot, the fatigue was less severe, coming in waves. However, I felt weak for more than two months, which I noticed since I go to the gum regularly. My strength has still not returned to where it was previously.

Tested Positive on January 6th, 2021 Bad headache, I hurt all over just like when I had the Covid Virus, Joints were the most painful, My body had hives on all places I was able to see, Eyes were very red with red rings around the outside of my eyes and eye lids, Nausea, my skin had a red look and there were red lines on my arms and legs, Every vein on my limbs were very pronounced, I had a "restless" arm and leg" vibrations and I had to get up and walk to make the feelings stop. I fought against the symptoms.

Pain in left arm (injection site), right upper arm muscle (less pain than left arm), left and right upper chest between collar bone and shoulders, chills all night with headache and tossing and turning, swollen lymph nodes behind both ears with an ear ache in right ear, profuse sweating, fever and temperature but not checked until 16 April around 9:00 AM. Read 100.4; 10:30 AM Read 100.6; continued going down from there. 17 April 7:00AM temperature read 97.1.

Experiencing chills, fever over 101 degrees, soreness and redness just above left leg ankle area. Also soreness/ pain in upper inside thigh area Just took 3 ibupropen about 11 am

Site: Pain at Injection Site-Medium, Systemic: Body Aches Generalized-Medium, Systemic: Felt \"unwell\" for 4 days-Medium, Error: Incorrect Reconstitution, Additional Details: Patient states that his right arm feels weaker than normal and is impacting him at this job.

Severe Shingles on left side of face affecting, ear, nose, eye, nose & side/top of head. Treated with Acyclovir 800mg 5x, Gabapentine 300mg 3x, Prednisone 20mg 1x for 5 days

8 to 12 hours after my first COVID-19 shot on 3/11, the outside of my left (non dominant ) wrist started to hurt. I had not injured or overused it. It has never hurt without a reason before. It has continued to hurt ever since (47 days). That was the only side effect I had other than a sore upper left arm (several days). Nothing changed after my second shot (lot #EP7533) on 4/11 (just a sore upper left arm again for several days). The pain has spread to the inside/underside of my wrist in the last week or so.

Hardening of surface artery after both first and second dose in arm vaccination was given. Some pain at outset.

He got the vaccine on a Friday, and felt sore after. On Monday he still felt pain on his back, but thought it was because of the vaccine. He also felt warm and itchy on his back and under arm as well. It started as a small patch that looked like a rash, and was very painful and itchy. By the end of the week he decided to go to the doctor because he couldn?t take the pin anymore and it was spreading and blistering. He was given Ibuprofen, and acyclovir ointment. The second visit on April 5th they gave him Gabapentin 100 mg.

I was diagnosed with Shingles on the 19th-20th of April, but also developed the rash a day of two prior to going to the doctor. I was placed on acyclovir and finished the first 7 day course. My doctor prescribed a second dose of acyclovir.

Dizzy spells when in bed. every night for 6 nights since injection. Have been drinking more fluids, checking blood pressure- but normal readings only. Rash in armpit on left arm. suddenly appeared 24 hours after injection. I have been treating with overcounter hydrocortisone 1%.

felt pain at injection site; dry mouth; feeling cold; dry eyes; rapid pulse; his breathing changed'; states it was hard to breathe; felt like he had fever; This is a spontaneous report from a contactable consumer (patient). This 64-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose on 04Apr2021 for COVID-19 immunization. Medical history and concomitant medication were not reported. Patient stated after injection, felt pain at injection site and felt like he had fever; fever lasted 2 days (as reported). Patient also added immediately after receiving the shot, he had a 'rapid pulse and his breathing changed' on 04Apr2021; stated it was hard to breathe. Patient stated he calmed himself and he was ok. Patient reported 2 weeks later after the first dose, he reported shortness of breath, dry mouth, feeling cold and dry eyes (unclear timing/onset). Patient stated these were ongoing currently. Patient was asking if these could be side effects. Patient also reported that he cannot take medications; he had allergies to medication (did not specify). Patient asked should he delay second dose given he had ongoing side effects from the first dose. The outcome of events was reported as unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

I have been suffering fron a Pfizer vaccine reaction for about a month and it does not seem to go away. I went to the doctor a week after the Pfizer 2nd dose and he told me to take Benadryl. I did and it went away for a few days but it came back after a week. I have had hives on my chest and underarms for about two weks now. Today, I have a hives again and my upper lip is swollen. Where should I go for something like this? I was vaccinated at CVS with my second dose about a month ago. I am 64 and I think I had an anaphilactic reaction to shrimp about 38 years ago. Thank you,

Client report receiving second COVID vaccine on 05/08/21 at 10:00 am and having an adverse reaction of hives on Monday 05/10/21 about 02:00 am. Client received first COVID vaccine on 04/10/21 without an adverse reaction. This adverse reaction from the second vaccine consist of hives on his buttock, armpits, back of head, back and front of legs. The hives are itchy in a couple of spots. They are not painful or tender. No other symptoms. Client has taken Benadryl, at this time but is not sure how helpful it has been as of yet.

Minimal local discomfort at injection site; This is a spontaneous report received from contactable consumer (patient). A 64-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: Unknown), via an unspecified route of administration on an unspecified date at a single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. Patient stated that he experienced minimal local discomfort at injection site following his Covid-19 vaccination on an unspecified date. The outcome of the event was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

shingles; This is a spontaneous report from a contactable physician. A 64-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 16Mar2021 (Batch/Lot number was not reported) as 1st dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On 22Mar2021, 6 days after the Covid 19 vaccine, the patient developed shingles. Physician doesn't think it was related to the Covid 19 vaccine. Physician prescribed the patient with valaciclovir (VALTREX) and a cream as the shingles were extensive on the patient's abdominal wall. The patient's next dose was on 06Apr2021 and physician was asking if it's ok for the patient to proceed in getting the second Covid 19 vaccine on that day or does the vaccine need to be delayed and if it needs to be delayed how long can it be delayed. Physician doesn't think it's a reaction, she just wants to know how long she can delay the patient getting the second Covid 19 vaccine. The patient developed the shingles on 22Mar2021 but the patient didn't see the doctor until today so he's had the shingles about 10 days. Does the patient go ahead and get the second dose or delay. Physician would like to know how many days you can delay getting the second Covid 19 vaccine. Physician doesn't think the rash is from the Covid 19 vaccine she thinks it's just a coincidence. Patient was in the office exam room. Physician would just like the question answered as the patient in the office. No further information was provided or obtained. Outcome of the event was unknown. No follow-up attempts are completed; information about lot/batch number cannot be obtained.; Sender's Comments: Event represents an intercurrent medical condition and unrelated to BNT162B2 .

pt developed generalized papular/drug rush 2 days after vaccine on all extremities and trunk. this eventually started to resolve after about 3 weeks and a course of prednisone. on 5/6 he developed shortness of breath/chest pressure worse on exertion. he was hospitalized with a negative cardiac workup (telemetry, trops, nuclear stress test) negative chest XR and negative CTA chest for PE. VS remained stable throughout. some improvement now with prednisone. unclear if related to his vaccine but pt feels it was.

Breaking out in a "Chicken Pox" like rash over a large portion of my body. Legs, arms, and torso. Extremely itchy and often painful.

I have a red itchy painful rash in my arm and head. I used clobesol ointment but there is no effect. I took acetaminophen and the itch from my arm goes away for a few hours but the itch from my head continues to bother me. On my head I tried the clobesol and it's good for less than an an hour. when it start to itch again, I washed my head with just water then tried Vicks Vaporub to freshen the head and the itch will go away for awhile.

Shingles. Active for about 1 month. Acyclovir 3/day x 7 days, prednisone, Augmentin 2/day x 10 days. Headache, earache, jaw pain, scalp pain, lesions from top of head to chin on left side of face, general fatigue

out-of breath; 1-1/2 days after injection began as rash on lower middle back-(looked like a picture of measles)-spread throughout entire body except for face/head over the next few days; moved into lungs-pressure; burning; This is a spontaneous report from a contactable consumer. A 64-year-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Right on 21Apr2021 14:30 (Batch/Lot Number: ER8731) as 2nd dose, single (at the age of 64 years) for covid-19 immunisation. The patient's medical history included high blood pressure from an unknown date and unknown if ongoing. The patient has not had Covid-19 prior to vaccination. The patient has no known allergies. Concomitant medications included lisinopril; diltiazem; and cholestyramine, all taken for an unspecified indication, start and stop date were not reported. The patient received the first dose, an unspecified route of administration, administered in Arm Right on 31Mar2021 11:30 (Batch/Lot Number: ER8737) for covid-19 immunization. On 23Apr2021 at 7:30, 1-1/2 days after injection began as rash on lower middle back-(looked like a picture of measles)-spread throughout entire body except for face/head over the next few days Despite treatment/testing at hospital has moved into lungs-pressure, burning and out of breath. It was reported that the events resulted to doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, and Hospitalization for 1 day. The had testing and breathing med as treatment for the events. The patient underwent lab tests and procedures which included sars-cov-2 test (covid): negative on 07May2021 via nasal swab. The outcome of the events was recovering.

Rash, inner thigh, both legs; This is a spontaneous report from a contactable consumer (patient). A 64-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 20Feb2021 at 10:30 (at the age of 64 years old) (Lot Number: EL9267, unknown expiration) as 1st dose, single for COVID-19 immunisation. Medical history included pre-diabetic and high cholesterol. No known allergies. Concomitant medications included rosuvastatin and metformin. The patient experienced rash, inner thigh, both legs on 20Feb2021 at 20:00. The patient did not receive treatment for the event. The patient has no COVID prior to vaccination and was not tested for COVID post vaccination. No other vaccine in four weeks. The patient had not yet recovered from the event. Follow-up attempts are completed. No further information is expected.

Severe rash, red scales dry patches on skin, red chicken pox like spots all over body, legs, arms, stomach and back

He got his vaccine, he had the localized pain for a day or two. Then about the 3rd day he noticed the pain was still there and when he holds the phone for a long time talking he starts feeling the pain. Also when he's laying down on the left arm after a while it starts hurting and he has to turn over to get rid of the pain, and this happens all the time and when he's laying down every night he has the pain. He cannot hold his phone in his left hand for a long time due to the pain. The pain is localized around the injection site itself. He has a friend that is having the exact same symptoms as well. He has not taken anything for the pain/reaction or called his doctor. This has been going on for almost 2 months and wonders if he has a blockage in that arm. This pain wakes him up at night and he has to switch locations in order to get rid of the pain.

Body rash on foot 4/3/2021 Edema/fluid in lungs 5/7/2021 Kidney Failure w dialysis 5/16/2021 CRRT & ECMO 5/28/2021

Hives inside inner legs, inner arms, wrists, chest; lumps on lips; This is a spontaneous report from a contactable consumer (patient). A 64-year-old male patient received second dose of BNT162B2 (Lot Number: EP7533), via an unspecified route of administration, administered in Arm Right on 02Apr2021 at 10: 00 AM at age of 64-year-old as single dose for covid-19 immunisation. Medical history included benign prostate hyperplasia, anaphilactic reaction to shrimp 40 years ago (in 1981). The patient received first dose of BNT162B2 (Lot Number: EN6207), via an unspecified route of administration, administered in Arm Right on 12Mar2021 at 09: 00 AM at age of 64-year-old as single dose for covid-19 immunisation. Concomitant medication included tadalafil taken for benign prostatic hyperplasia. Facility where the most recent COVID-19 vaccine was administered was pharmacy or drug store. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The adverse event result in Doctor or other healthcare professional office/clinic visit. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. On 10Apr2021 at 07:00, one week after patient's second dose, patient had Hives inside inner legs, inner arms, wrists, chest, and lumps on lips. Patient went to dr. twice and was advised to take Benadryl. The patient did and then they subsided. They started again after stopping the Benadryl. The rection started. If the patient stopped fexofenadine (ALLEGRA), he was taking the hives come back. The outcome of events was not recovered. Further information has been requested.

injection site was painful and uncomfortable; fatigue/feeling of tiredness; nausea; chills; hot; pain in his arm of injection; This is a spontaneous report from a contactable consumer or other non hcp. A 64-years-old elderly male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot:Unknown),via an unspecified route of administration on 11May2021 as second dose, Single Dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient historical vaccine was bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE),via an unspecified route of administration as 1st Dose, Single Dose for COVID-19 immunization Within 6-7 hours, on 11May2021,the patient experienced fatigue, nausea, chills, hot, feeling of tiredness, pain in his arm of injection ,injection site was painful and uncomfortable. The events resolved within 48 to 72 hours except for the arm pain which was still persisting. The outcome for the event pain in extremity was not recovered/not resolved, vaccination site pain was unknown and rest of the events was recovered/resolved. No follow-up attempts are needed. No further information is expected.

Arm hurts where shot was administered. (Like muscle pain). Two days later, tiredness and occasional light stomach ache. Four days later, slight back pain on both sides like punched kidneys that continued for a week. Rash developed on ankles of both feet that has continued till present. (applying Hydrocortisone with slight success) Have an appointment with dermatologist 6/17. Joints started aching all over with 2 areas (left Ankle and right elbow) continues to have pain. These were areas that had old injuries but had no prior pain before the vaccine 2nd shot.

Had no decent sleep for the last few nights; His mouth wide open which then makes him dehydrated of course; His mouth wide open which then makes him dehydrated of course; Moving so slow and had lower back and thigh tightness; shoulder aches like someone took a bat and hit it/ feels like he was 80 years old/ it looks like it is something with air in his bloodstream; Has no energy and the pain is like it is hitting a nerve where he barely can pick up 5 pounds; Has no energy and the pain is like it is hitting a nerve where he barely can pick up 5 pounds; Has no energy and the pain is like it is hitting a nerve where he barely can pick up 5 pounds; Had intense pain and soreness to his upper body, shoulder blades, and neck area, biceps and triceps/it hurts from his elbow down to his shoulder and it aches; Had intense pain and soreness to his upper body, shoulder blades, and neck area, biceps and triceps/his shoulder area on the right side is a little bit in pain; Had intense pain and soreness to his upper body, shoulder blades, and neck area, biceps and triceps; He is sore and tight on his upper body like his chest, both arms, his shoulder blades, biceps, triceps, lower neck muscles and on his shoulder blades behind him; He is sore and tight on his upper body like his chest, both arms, his shoulder blades, biceps, triceps, lower neck muscles and on his shoulder blades behind him; he has some pain and there was pain in his triceps, he also has pain between those muscles, it hurts, and It was maybe where he had the COVID vaccine; He is sore and tight on his upper body like his chest, both arms, his shoulder blades, biceps, triceps, lower neck muscles and on his shoulder blades behind him; He is sore and tight on his upper body like his chest, both arms, his shoulder blades, biceps, triceps, lower neck muscles and on his shoulder blades behind him; He is sore and tight on his upper body like his chest, both arms, his shoulder blades, biceps, triceps, lower neck muscles and on his shoulder blades behind him; He rotates his head and looks around, neck pops frequently; This is a spontaneous report from a contactable consumer (Patient). A 64-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), second dose via an unspecified route of administration on 17May2021 (at the age of 64-year-old, Batch/Lot Number: EW0177) as a single dose for COVID-19 immunisation. Medical history included was walking pneumonia twice and other than that just a typical flu. The patient races dirt bikes so he was tough. Also, he had carpel tunnel from his job, and he had left over pain pills from that, and he had been taking them to help reduce the pain since he cannot really do anything about his side effects. Concomitant medication included pain pills, no other products reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), first dose via an unspecified route of administration on 26Apr2021 (Batch/Lot Number: EW0162) as a single dose for COVID-19 immunisation and on an unspecified date in Apr2021, experienced muscle stiffness and soreness that was in left arm and around his buttocks and his thighs and reported felt soreness for a few days afterward. This report is not related to study or programme. It was reported that, honestly, he wishes he never got it because he cannot do anything. He was on the fence about getting it since we are at the end of the pandemic and the hospitals are not as overwhelmed anymore. Everyone thinks that he was still in his 50's, he was very healthy, and he has no medical or health issues and he works out all the time, which was why he was so concerned about why it was affecting him like this. He has had his second dose of the COVID vaccine, and he wanted to report what was going on with his body. It was reported that, then he got the 2nd dose and within a day or two he was sore, and he was at the 11th day of experiencing this. He was sore and tight on his upper body like his chest, both arms, his shoulder blades, biceps, triceps, lower neck muscles and on his shoulder blades behind him. He had his 2nd dose not last Monday but the Monday before that. It did dissipate during the day. He jokingly said it was like the Pfizer vaccine retreats and hides during the day. Because of this he has had no decent sleep for the last few nights. His shoulder aches like someone took a bat and hit it. It feels like that on his left arm too but a little less pain. He was a side body sleeper, and he cannot sleep on his side because of this so then he ends up sleeping on his back with his mouth wide open which then makes him dehydrated of course. he has no energy, and the pain was like it was hitting a nerve where he barely can pick up 5 pounds. This was an extending issue and he just wanted to report and see if anyone else has had this before. The hospital said that they have not had anyone else report this before. It was slowly dissipating but he did not understand why it reinforces itself in the evening. Yesterday, he had to go service a customer and he was moving so slow and had lower back and thigh tightness. His upper body was sore and tight so when he got home, he was walking around trying to get his blood flowing and stretching some but then in the middle of the night those reserves came out and he gets attacked. The stiffness, soreness and pain were all concentrated mostly on his upper body. Also, his neck pops and he has never had that happen before. He looked it up and it looks like it was something with air in his bloodstream or something and when he rotates his head and looks around it makes a pop sound, and it has been doing it ever since his 2nd shot. He says this started probably on 18May2021 right after the vaccine. The patient clarified that for the side effects after his second dose that began soon after the COVID vaccine and he states that it was like all hell broke loose. This has gotten a little bit better but not a lot. Maybe 10% better or maybe 15% better. As he was sitting there his shoulder area on the right side was a little bit in pain. He feels like he was 80 years old, he was walking slow, and his body was stiff. No further details provided on the pain pills. He says he was flexing his bicep and he has some pain and there was pain in his triceps. He also has pain between those muscles, it hurts. It was maybe where he had the COVID vaccine. He also has this same pain on the left side except his bicep doesn't hurt but his tricep does and it hurts from his elbow down to his shoulder and it aches. On a scale of 1-10 his pain was at a 3-4 but at night it was worse. The patient and health care professional consent to be contacted was reported as yes. Investigation assessment was reported as no. The outcome of the events Sleep deficit, oral disorder, dehydration, hypokinesia, feeling abnormal was unknown and for all other events recovering. Information on Lot/Batch number was available. Additional information has been requested.

Site: Redness at Injection Site-Mild, Additional Details: About 5 min. after immunization, pt fainted, pt had pulse and breathing but high BP 180/89; paramedic were called & pt was take to ER. Per pt wife, he had history of fainting with injwection & blood tests. Also he has cardiovaculary disease and pacemaker. I recieved all these info after pt. faining; if I was informed prior; I would have recommended pt to recieve vaccination at hospital location.

Vaccine was administered in right arm. Experienced mild pain for about 24 hours; I did experience itching on my lower back, buttocks, and back of both legs for about 36 hours. No rash but a moderate itching sensation; This is a spontaneous report from a contactable consumer (patient). A 64-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection) via unspecified route of administration, administered in arm right on 04Mar2021 at 12:45 (PM) (at the age of 64-year-old) as 1st dose, single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously took flu vaccination (annual flu vaccination) and experienced mild pain. No other vaccine in four weeks and no treatment received. No covid prior vaccination and did not tested covid post vaccination. The patient known allergies were none. The patient got vaccine in right arm and experienced mild pain on an unspecified date Mar2021 (for about 24 hours) similar to that of the annual flu vaccination, itching on his lower back, buttocks, and back of both legs for about 36 hours. No rash but a moderate itching sensation. Outcome of the event was recovered on an unknown date in 2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Swelling & rash on left side of face affecting left ear, temple, cheek, nose, left eye & upper lip. 1 week Predisone, but symptoms remained severe for at least 4 weeks. Now, 7 weeks later I still have numbness on left side of my nose with a lot of itching feeling in nostrils, temple, cheek & left eye. Still taking 3x Gabapentine 300mg, Amitriptyline 10 mg & eye drops/ointment Neomycin & Polymyxin B Sulfates & Dexamethasone Ophthalmic. I have not had my Shingles vaccine but plan on getting it in about 3 months

After my second dose, I experienced fatigue and fever but my symptoms only lasted 4 days. I now have a white mark on my skin that is inflamed, located on my left forearm radiating to my left hand. I do not know how I got it and my PCP sent me medication to my home address, where I am to take this pill orally to help decrease my inflammation. I did not have this mark before receiving my Pfizer vaccine and this is very concerning to me.

Approximately 3 1/2 weeks after vaccine- increasing neck pain on right, enlarged lymph node right axilla, then pain in wrists, right > left, painful to do pushups or turn lids, red and swollen. LN resolved with zpack. Still some pain in wrists and swelling in fingers, pain in right side neck.

Both arms broke out with a rash of little fine bumps; This is a spontaneous report received from a contactable consumer, the patient. A 64-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in the left arm on 27Feb2021 at 02:15 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. Medical history included diabetes. 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 medications were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 10Mar2021 at 00:00, the patient's both arms broke out with a rash of little fine bumps. The patient did not receive any treatment for the event both arms broke out with a rash of little fine bumps. The clinical outcome of the event both arms broke out with a rash of fine bumps was not resolved at the time of the report. Information about lot/batch number cannot be obtained. No further information is expected.

This is a spontaneous report received from a contactable consumer, the patient. A 64-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER2613) via an unspecified route of administration in the left arm on 20Mar2021 at 15:00 (at the age of 64-years-old), as single dose for COVID-19 immunisation. The patient medical history included depression, GERD, PTSD, mild seasonal and dust allergies, rosacea, mild asthma, cancer survivor (15 years), and allergy to sulfa drugs. Concomitant medications were not reported. 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 vaccination. Since the vaccination, the patient had not been tested for COVID-19. On 20Mar2021 at 20:00, the patient experienced mild soreness in his left arm at injection point, fatigue, body aches. Arm pain noticed about 5 hours after inoculation. He awoke the next morning with aches and fatigue, about 18 hours after injection. Therapeutic measure were not taken as a result of the events. The clinical outcome of soreness in left arm at injection point, fatigue, body aches was resolving. No follow-up attempts are needed. No further information is expected.

sore arm where vaccine was injected,; This is a spontaneous report received from a contactable consumer, the patient. A 64-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 left arm on 06Mar2021 at 00:00 (at the age of 64-years-old), as a single dose, for COVID-19 immunisation. Medical history and concomitant medication were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 06Mar2021, at 12.00am the patient experienced sore arm where vaccine was injected which lasted about 7days. No therapeutic measures were taken as a result of adverse event. The clinical outcome of the event vaccination site pain was resolved on an unknown date in Mar2021. No follow-up attempts are needed. No further information is expected.

left arm injection site was very sore to the touch.; fever of 101 the first night; severe body aches; This is a spontaneous report from a contactable consumer. A 64-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: EN6204) via an unspecified route of administration in the left arm on 17Mar2021 at 14.30 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism and non-alcoholic steatohepatitis (NASH). The concomitant medications included levothyroxine sodium (SYNTHROID), gabapentin (MANUFACTURER UNKNOWN) and atorvastatin (MANUFACTURER UNKNOWN) for 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 24Feb2021 at 15.30 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any vaccination 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 been not tested for COVID-19. On 17Mar2021 at 19.30, the patient experienced severe body aches, fever of 101 the first night and on 18Mar2021, experienced vaccination site sore. Patient took Advil but fever stayed over 99. Second day patient had fever and body aches continued. On the second night fever went to 101.9 and patient had continued body aches. Advil was continued as directed and fever with Advil was 100. On the third day morning, the fever had subsided and on 20Mar2021 at 10:00 the patient was like normal and able to work. Treatment was taken for the events, severe body aches, fever, vaccination site sore with ADVIL. 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 severe body aches, fever and vaccination site sore was resolved on 20Mar2021. No follow-up attempts are possible. No further information is expected.

Shingles advanced to eye. IV Acyclovair- Emergency admitted to hospital for one week. No resolution.

Pain around injection site; stiff shoulder; left muscle sore; This is a spontaneous report from a contactable consumer (patient himself). A 64-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: en6198), via an unspecified route of administration in the left arm on 23Mar2021 at 14:00 (at the age of 64-year-old) as dose 2, single for COVID-19 immunisation. The patient medical history was not reported. The patient previously received bnt162b2 (lot number: er2613) on 22Mar2021 administration on left arm as dose 1, single for COVID-19 immunisation. The patient received other medications within 2 weeks of vaccination. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 23Mar2021, 08:00 AM, the patient experienced pain around injection site, stiff shoulder, left muscle sore. The patient did not receive any treatment for the events. The outcome of the events was reported as recovering. No follow-up attempts are needed. No further information is expected.

got tired; On 01Jul I got one the size of a silver dollar (hematoma). It does not hurt and I did not bump ag; have been getting these like blood bleed under my skin on my arm; blood bleeds under his skin on his arm; began getting red spots (like a blood spot) on my arm. On July 1st I got one the size of a silver dollar (hematoma). It does not hurt and I did not bump ag; This is a spontaneous report from a contactable consumer or other non hcp. A 64-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Right on 04May2021 (at the age of 64 years old) (Batch/Lot Number: EW0167) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient has no known allergies. The patient was not diagnosed with COVID-19 prior to the vaccination and has not been tested for COVID-19 since the vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Previously the patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on 09Apr2021 at 13:00 (at the age of 64 years old) (Batch/Lot Number: EW0153) as single dose for COVID-19 immunisation. It was reported that after receiving the Pfizer Covid vaccine the patient on 13May2021, the patient began getting red spots (like a blood spot) on arm. On 01Jul2021 he got one the size of a silver dollar (hematoma). It did not hurt and did not bump against anything. He would like to know if this a side effect of the Covid vaccine. Have others reported this symptom, How many? The patient was not on any blood thinners and a very healthy adult male. He has become large, blood bleeds under his skin on his arm; this has happened 4 times now. It was reported that last Thursday he couldn't go to his work, got tired. The patient was a very healthy old man and ever since he got the vaccine, he started to have this, under the skin bleed and spots, red spots and bleed on arms. The adverse event resulted in Doctor or other healthcare professional office or clinic visit on 12Jul2021 and received treatment. The outcome of the events was not recovered and fatigue was unknown.

This form fails to ask about the second dose of the Pfizer COVID-19 vaccine. My 2nd dose was given on 1/11/2021, Lot No, EK4176, IM, left arm. About 2 weeks after my second dose of the Pfizer vaccine, I developed what has been called "COVID toes," tender, burning, numb, toes with splotchy areas of redness. This waxed over a few weeks and then waned. It was minimal by 6 weeks, and resolved completely in the following weeks.

Headache; injection site pain; loss of balance; mental fog; congestion; breathing difficulty; lethargy; This is a spontaneous report from a contactable consumer, the patient. A 64-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 arm left on 02Apr2021 at 08:15 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. Medical history included COPD and COVID-19. Concomitant medications included atorvastatin calcium (LIPITOR) and fluticasone propionate, salmeterol xinafoate (ADVAIR) both for an unknown indication and from an unknown date. The patient previously received levaquin for an unknown indication and experienced drug allergy. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 02Apr2021 at 16:00, the patient experienced headache, injection site pain, loss of balance, mental fog, congestion, breathing difficulty and lethargy. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department, or urgent care. No therapeutic measures were taken as a result of events. The clinical outcomes of the events headache, injection site pain, loss of balance, mental fog, congestion, breathing difficulty and lethargy were not recovered at the time of this report. No follow-up attempts are needed. No further information is expected.

Severe hives (weeping), onset 48-hours post-injection. Lasted 11-days.; This is a spontaneous report from a contactable consumer, the patient. A 64-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 right arm on 29Mar2021 at 15:00 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. Medical history included sulfonamide allergy. Concomitant medications included lisinopril (MANUFACTURER UNKNOWN), and omeprazole (MANUFACTURER UNKNOWN) from an unknown date for an unspecified indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 31Mar2021 at 14:00 the patient experienced Severe hives (weeping), onset 48-hours post-injection. The patient did not receive any treatment for the event. 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 hives was recovering. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Red rash at point of injection; Red rash at point of injection; This is a spontaneous report from a contactable consumer, the patient. A 64-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 05Apr2021 at 11:30 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not receive any other medications within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 08Apr2021, the patient experienced red rash at point of injection( vaccination site rash; vaccination site erythema). Therapeutic measures were not reported. The clinical outcome of the event red rash at point of injection was resolved on an unknown date in 2021. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

injection site pain; facial swelling; fever; joint pain; chills; aches; feeling unwell; This is a spontaneous report from a contactable physician who reported for himself. A 65-year-old male patient received the first single dose of BNT162B2 (Pfizer/ BioNTech Covid-19 vaccine) at left arm at 05:00 PM 02Jan2021 for Covid-19 immunization in his workplace clinic. The patient had a medical history of controlled hypertension. The patient had no known allergies to medications, food, or other products. Concomitant medications included telmisartan for blood pressure. The patient had not received other vaccines within four weeks. Commencing exactly 24 hours after vaccine received, on 03Jan2021, the patient developed facial swelling, fever chills aches joint pain feeling unwell, injection site pain lasting for 18 hours. The patient had not received treatment. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. All the events resolved. The patient considered that the events were non-serious. Information on batch/lot number was requested.

Cheek swelling; Periorbital swelling/swelling around his eyes; feeling wiped out; Muscle pain; Joint pain; Chills; Fever; General malaise; low grade headache; Sweating; injection site pain; This is a spontaneous report from a contactable physician (patient). A 65-year-old male patient received bnt162b2 (BNT162B2) at single dose at left deltoid on 02Jan2021 17:00 for covid-19 immunisation, administered an injection team that is part of the local hospital system. Medical history included controlled hypertension and he has been taking the blood pressure medicine for a long time. The concomitant medications included unspecified medicines for controlled hypertension. History of all previous immunization with the Pfizer vaccine was none. The patient had not received any other vaccines within 4 weeks prior to the BNT162B2 vaccine. No additional vaccines administered on same date of the BNT162B2 vaccine. On 02Jan2021 the patient experienced injection site pain. On 03Jan2021 the patient experienced cheek swelling, periorbital swelling/swelling around his eyes, feeling wiped out, muscle pain, joint pain, chills, fever, general malaise, low grade headache, sweating. No event did require a visit to Emergency Room or Physician Office. No relevant tests performed. Therapeutic measures were taken as a result of chills, fever, general malaise, low grade headache, sweating. Course of events: He said initially he had no adverse events after receiving the COVID-19 Vaccine, except injection site pain. He said he thought the injection site pain could be from the COVID-19 Vaccine being viscous, and didn't think anything else about the injection site pain. On 03Jan2021 he started to experience some. He stated he did not normally take vaccines, like the flu vaccine. He said he has been a podiatrist for 39 years, and realized the importance of getting the vaccine to protect his patients. He then developed chills, muscle pain, fever, and general malaise. He said he experienced every side effect listed on the received COVID-19 Vaccine paperwork, except he had no lymphadenopathy. He said all the side effects he experienced appeared 24 hours to the minute from when he received the COVID-19 Vaccine. On 03Jan2021, he had swelling in his cheeks and around his eyes. He did not get sick often. He said he had a rough night on 03Jan2021 and on 03Jan2021 he still felt wiped out. Treatment: he took 2 Tylenol 325mg at the start of the side effects, and then took another 2 Tylenol 325mg at 2:00AM. He said he woke up soaking wet with chills and sweats. He said his fever broke, but he did not know how high his fever was. He took from a fresh bottle of Tylenol 325mg. The outcome of injection site pain, cheek swelling, periorbital swelling/swelling around his eyes, feeling wiped out, muscle pain, joint pain, general malaise was recovering, of chills, fever, sweating was recovered in Jan2021, of low grade headache was not recovered. The reporter considered there was a reasonable possibility that all events were related to bnt162b2 vaccine. He was scheduled to receive another COVID-19 Vaccine injection in 3 weeks. Information about lot/batch number has been requested.

Arm was sore at the injection site; This is spontaneous report from a contactable consumer (patient). A 65-year-old male patient received of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) first dose on 18Dec2020 at 10:30 A.M (lot number: EK5730) and second dose on 08Jan2021 at 10:15 (lot number: EL0140); both taken via unspecified routes of administration, in the left arm, at single doses, for COVID-19 immunization. The patient has no relevant medical history and has no known allergies. Concomitant medication included rosuvastatin calcium (SUVASTATIN). The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in the facility. On 18Dec2020, at 15:00, the patient's arm was sore at the injection site. On 08Jan2021, at 16:00, the patient's arm was sore at the injection site. The patient did not receive treatment for the event. Outcome of the event was recovered.

Really nothing -- a little pain in left arm, where shot was administered. The same feeling -- not quite pain -- that I had with the very first flu shot I received over 35 years ago!

"pretty big" right arm swelling; flu-like symptoms the day after vaccination; vesicle formation on his one big toe; Herpes Whitlow; This is a spontaneous report from a contactable HCP reported for self. This 65-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown) via unspecified route of administration on 09Jan2021 at single dose for COVID-19 immunization. The patient medical history and concomitant mediations was not provided. The patient experienced reported "pretty big" right arm swelling, and flu-like symptoms the day after vaccination (10Jan2021), both of which have resolved. He is asking about the incidence of what he described as "Herpes Whitlow" vesicle formation on his one big toe. The patient stated that it could be from beginning to run after a couple week hiatus. The patient stated he had been running which he hadn't been doing for a week or two. He has reviewed the literature and can find nothing. The outcome of events swelling in the right arm, and flu-like symptoms was resolved. The outcome of other events was unknown. Information on the Lot/batch number has been requested.

The injection site started hurting at 1/23/21 at 10:00 PM Around 1:00 Am on 1/24/21 I started feeling fatigue. All day 1/24/21 I felt some fatigue, but not as bad as first shut. Around 6:00 Pm on 1/24/21 huge sweat came on me I became very hot, then few minutes later, it all disappeared, then I felt good, no more side effects.

He described having a lump in his throat as well as hives and itching 1 hr after his first vaccine. Then, had taken Benadryl and sx were self limited. For the 2nd vaccine, he premedicated with Benadryl with a plan to observe 30 min. Approx 23 min after injection, developed L arm burning and redness. He developed a lump in his throat. BP 137/90, HR 71, SpO2 97%. He was directed to the ER where he received Benadryl, Solumedrol, Pepcid and was discharged home.

He woke up with nausea, headache, very sore injection site, fever of 101. He couldn't move his left arm up higher than his waist. He took Ibuprofen OTC, rested, felt ok by evening. Next day, no side effects remained.

About 25 minutes after vaccine a pain started at the injection site and went to left shoulder and up the left side of my neck. I had a lot of pain for about 10 minutes. Most of the pain went away about 10 minutes after it started.

I had an ongoing localized skin rash on left leg and right hand at time of covid vaccination. Approximately 2 day after shot I had single bumps/ rash on back of neck, arms and face. I have been treating with Zyrtec and Hydrocortisone Cream.

injection site pain, headache, muscle pain, chills, joint pain, and nausea. Started 0300 02 Feb 21, ended 1000 02 Feb 21.

Pfizer-BioNTech COVID-19 Vaccine EUA Monday February 1, 2021 Injection in left shoulder was at 1 PM Monday. First noted slight pain at injection site about 12 hours after injection. Tuesday February 2, 2021 Shoulder pain at injection site increased to moderate level, slightly more than fall flu shot . Noted some body and joint aches. Wednesday February 3, 2021 First noted left lymph node under left arm (armpit area) was swollen approximately 43 hours after injection of vaccine after waking up on Wednesday morning. Shoulder pain at injection site is still considered to be moderate.

A couple hours after receiving vaccine, bumped back of deltoid and noticed had a painful boil. The boil wasn't at the vaccination site. Hasn't subsided over 2 weeks. Hasn't tried any other remedies. Hasn't tried anything to improve it. No pus so hasn't tried to pop it.

He c/o of infected tooth on 01/23/21, antibiotics began Swelling in both hand began on 01/30/21. Resident c/o of itching in arm. Antibiotics discontinued, benedryl given as needed. Symptoms resolved 02/02/21

a mild rash on my forearms and front of my legs; numb tongue; This is a spontaneous report from a contactable consumer (patient). A 65-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 18Jan2021 14:30 at a single dose for covid-19 immunisation. Medical history included mild hypertension, elevated cholesterol, allergy to sulfa, allergy to gluten and celiac disease. The patient's concomitant medications were not reported. On 18Jan2021 15:30, patient experienced mild rash on his forearms and front of his legs which was treated with diphenhydramine (BENADRYL) tablet. The patient also experienced numb tongue on 18Jan2021 15:30 with no treatment received. Outcome of event "mild rash on my forearms and front of my legs" was unknown while for the event "numb tongue" was not recovered. Information on the Lot/Batch number has been requested.

About 2 hours after receiving the vaccine, patient had mild itching on upper chest, scalp, neck and eyes. Took 25 mg of Benadryl and I hour later, symptoms resolved. 10 hours later, itching returned and patient took another 25 mg of Benadryl. He noted small blanching palm-sized rash on upper sternum and had mild erythema on his neck. These symptoms eventually resolved.

Injection at approximately noon on 2/4/21. Began feeling poorly with flu like symptoms about 11 PM Fitful Sleep.Extreme soreness at injection site. Awoke with fever (100.7), joint pain, nausea, lethargy. Took 400 mg of ibuprofen. Took "Nyquil" the next evening to help with symptoms. Fitful sleep and extreme sweating. Awoke Saturday feeling a bit better. Temperature (98.6) Rested all day. Better sleep Saturday night. Did not take any medication. Some sweating overnight. Awoke Sunday feeling better. Still not 100 percent Temperature 97.4.

Slight pain and tenderness the first 24 hours then a mild itching sensation began the following day and through this submission on 2/8/2021. There is no redness or apparent rash, but the injection site is still tender.

face got very red; Fever; got a cough; Chills; little aches; slightly productive cough; This is a spontaneous report from a contactable consumer (patient) from a Pfizer Sponsored Program Pfizer . A 65-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 14Jan2021 at single dose for covid-19 immunization. The patient medical history included Exposure to SARS-CoV-2 and concomitant medications were not reported. The patient received the Pfizer COVID-19 vaccine on Thursday 14Jan2021. He felt great after receiving the injection, then got a cough and fever. On 18Jan2021 and 19Jan2021 he was around someone who was positive for COVID-19. On Friday 22Jan2021 he reported having chills, no fever, body aches and a slightly productive cough. On Sunday 24Jan2021 he checked his temperature and it was 99.5 F. He he took two tylenol and he had not had a fever since that time. Between Friday 22Jan2021 and today (25Jan2021) he had multiple (4) COVID-19 tests that all returned negative. He went to the doctor yesterday morning (24Jan2021) and started on steroids and an antibiotic. He was also reporting that his face was red this morning (25Jan2021) when he woke up. He wanted to know if he continued to be negative for COVID and these were side effects from the vaccine can he still received the second dose of the Pfizer COVID-19 vaccine. He was told by someone that if take a 'Regeneron Infusion for COVID' then he would have to wait 90 days to receive the next dose of vaccine, he asked was that true? He wanted to know if it's possible to have side effects a week after receiving the first dose of the Pfizer COVID-19 vaccine. He asked "Let's say I end up testing positive for COVID, do I still get the second dose of the vaccine? Let's say I do have COVID-19 that means I would have antibodies from that and then I would have antibodies from the first dose of the vaccine so would that mean that I'm covered and protected from COVID then?" He had taken a few Covid tests and all come back negative. Caller was wondering if this was just his body reacting to the vaccine. On 18Jan2021 and 19Jan2021 he came into contact with someone with Covid and on 22Jan2021 he took the Covid test. He said that he had chills that night 22Jan2021 and the next day 23Jan2021. He was told by the doctor to get the PCR test. He took the test in the morning and it tested negative 23Jan2021. That night he had someone came by his house and he took the test at 18:00 and took the test again at 20:00 at his doctors office. He said that all of the tests were negative. He said that he was testing so much so he could take the cocktail. The doctor prescribed Doxycycline Hyclate to take twice a day and prescribed Dexamethasone 6mg. He stated that his symptoms chills on Friday and Saturday and he had the start of a cough. He said that he had little aches on Saturday, but they were gone later that day. On Sunday morning (24Jan2021), he was prescribed these 2 things and by 11:00 had a fever of 99.5. The cough was not bad, and he had no aches. He took 2 Tylenol. He said that he took his temperature from 16:00 24Jan2021 Sunday until now, and he had no fever anymore. He would feel a little something in his cough, but it was getting better he said probably because of the medications. He stated that he got tested for strep, but had not received the results. He said that today his face got very red and it was red for about 1.5 hours, but was fine now. He said that he wanted to know, Does the vaccine have some of the antibodies working at this moment? Due for his second dose 04Feb2021, if keeps testing Negative and the symptoms didn't come back does he still get the vaccine on 04Feb2021? If he does have Covid and has no symptoms does he take his vaccine on 04Feb021? If he tests positive and takes the Regeneron cocktail, does he have to postpone the the 2nd dose for 90 days? The outcome of events was unknown. information about lot/batch number has been requested.

Pt is s/p liver transplant in May 2012 on chronic immunosuppression medication. He received first dose of Covid vaccine on 1/29/2021. On routine labs on 2/5/2021, LFTs were significantly elevated from baseline - ALT 123 (27), AST 66 (21), Alkaline Phosphate 242 (127), Total bilirubin 2.8 (0.3), Direct bilirubin 1.9 (<0.2). He did report new full body itching the day before. As a result of elevated labs, the patient presented to the emergency room due to concerns for biliary obstruction versus graft rejection. Repeat liver function tests were still elevated, although slightly better. Abdominal US was normal, no signs of dilatation or obstruction with patent vasculature. Pt was admitted to the inpatient transplant unit overnight and labs repeated on 2/6 showed continued improvement. With this, pt was continued on the same immunosuppressive med regimen and discharged home with close outpatient transplant follow-up.

lower back muscle twitching; At 20Jan2021 04:30 woke up with his left lower back muscle twitching; back and neck stiffness; soreness in left arm (injection arm); This is a spontaneous report from a contactable physician (patient). A 65-year-old male patient received first dose BNT162B2 (Pfizer BioNTech Covid 19 vaccine, lot number EL8982), via an unspecified route of administration at Arm Left on 19Jan2021 08:45 at the 65 years old at single dose for COVID-19 immunization. The medical history and concomitant medications were not reported. At 19Jan2021 13:45 the patient experienced soreness in left arm (injection arm) and took 800 mg Motrin. At 19Jan2021 20:00 developed back and neck stiffness. Took another dose of Motrin. At 20Jan2021 04:30 woke up with his left lower back muscle twitching. He felt back asleep and woke up at 20Jan2021 8:00 will all symptoms resolved. The outcome of the events soreness in left arm, back and neck stiffness, lower back muscle twitching was recovered on 20Jan2021 08:00, the event woke up was recovered on 20Jan2021.

marginal pain 3 inches below the injection site/arm sore; This is a spontaneous report from a contactable Other Health Professional (patient). A 65-year-old male patient received 1st dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: FL9263), intramuscularly on 22Jan2021 at single dose for COVID-19 immunisation. Medical history included type 2 diabetes. Concomitant medication included metformin for type 2 diabetes and rosuvastatin for unknown indication. Patient reported marginal pain 3 inches below the injection site as his only side effect. His arm was sore, a little late last night. Maybe later last night (22Jan2021), so maybe 8 hours after the injection. Patient meant the injection was painless. Patient stated, "A little bit. It's not that bad, it's better, it is improved." Treatment included "Ice pack". His second dose was scheduled for 19Feb2021, 4 weeks after the first dose. Patient had COVID-19 test on unknown date and was negative. Outcome of the event was resolving.

arms were sore; feels unwell; Tiredness; chills; this morning about 8 am I was running a fever 101.5; muscle ache; joint pain/joint aches; severe injection site pain; swelling and redness in left arm at injection site; swelling and redness in left arm at injection site; This is a spontaneous report received from a contactable consumer (patient). A 65-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247, expiration date listed on the card was either 03May2021 or 31May2021), intramuscularly in left arm on 24Jan2021 13:30 at 0.3 ml single for COVID-19 immunization. Medical history included COVID from Jun2020. Concomitant medications were none. Patient received the first dose of the vaccine, initially before bed he noticed his arms were sore, about 2 a.m., his arm was so sore it woke him up when he rolled over on it. It hurt throughout the night, he started to get chills, just like when he had COVID earlier in the year and this morning about 8 a.m. he was running a fever 101.5, muscle ache and joint pain. He felt exactly how he felt, when running a fever. He was experiencing 8 of the 12 side effects, none of the allergic reactions only fever, joint aches. He was experiencing about 90% of the side effects listed on page 3 the paperwork he received. He was not having any breathing issues. He had severe injection site pain on 24Jan2021, it literally felt like he had surgery on his left arm. Since he woke up this morning around 6 a.m. he had been experiencing tiredness, muscle pain, chills, joint pain, and he had a fever of 101.5 all on 25Jan2021. He had swelling and redness in his left arm at injection site on 24Jan2021. He didn't feel any lymph node swelling and he was not sick. He felt unwell. He felt like he twisted his shoulder, he went to bed and he woke up shivering like he had the COVID virus. He had the COVID virus back in Jun2020. The injection site arm pain was severe in the middle of night, and woke him up in the middle of the night. When he rolled over, he explained that he used both arms to help get out of bed and he could barely get up to go to the restroom. He was wrapped up so the chills were pretty good, when he woke up they were racking chills (which he also experienced these type of chills when he had the COVID virus). No treatment was received. He needed a magnifying glass and to get in the light to see the lot number on the card he was given. He took a boatload of drugs. Reported the details about his medications could be obtained from this hcp. He did not know them off the top of his head. Outcome of events arms were sore and felt unwell was unknown and of other events was not resolved.

On day seven after receiving the vaccination, a rash appeared on the back of the neck that progressed around the entire neck by day eight. On day nine rash appeared on the back of both arms and significant left arm pain distal to the injection site accompanied by inflammation. The inflammation appears to be present all over.

Arm was sore the next day on the 9th after the 2nd vaccine but starting on the 3rd and 4th day the soreness increased and certain movement and particular simple movements had sharp pain in the shot area. It hurts to lift arm. It feels like I tore something at the vaccination area.

02/07/2021- AM have abundance of floaters in right eye, not had previously. Later in day had some nausea, headaches and extreme soreness at swelling site but those 3 issues went away after a few hours. That evening I started getting what I will call "Lightening Bolts" flashing along the outer right edge of my right eye when I moved my head side to side. 02/08 & 09/2021- "Lightening Bolts were constant and I went to hospital.

2 inch x 2.5 inch bruise around the injection site. Darker bruise at the actual site (1 inch x 1.75 inches) and fanning outward, lighter in color. Minor discomfort only on the day after injection. Sleepy for a couple of days, but feeling fine. No pain there now. I wouldn't have noticed it if I hadn't looked. The only concern is that it has been 6 days since the injection.

pt anxious has flushed feeling; face red; has previous anxiety observed for 15 minutes; pt says he has ipipen and will go to er if symptoms worsen or still present in24 hrs. insisted on leaving.

Had minor itching/ pins and needles feeling sporadically at different locations of my body starting about 1 hour after vaccine injection. Pins and needles feeling grew less and less each day. All symptoms gone by day 6 after vaccine injection. As a side note, my last flu shot was about 8 years ago and I had the same symptoms after the shot.

Intermittent soreness in area of the vaccination, Moved arm in circular motions for relief. Soreness completely gone after 24 hours.

Finger nail size welts/rash on both thighs and forearms. appears during night and was itchy. Applied hydrocortisone cream at night and in morning. Took 1 Benadryl after about 14 hours after onset. Mostly disappeared by 3 PM

Sore arm at injection sight begging about 4 hours after injection continuing till day 3, Diarrhea beginning day 3 about 4:30 Am continuing into the afternoon. Diarrhea not severe, but prevented me from leaving the house to perform scheduled activities.

24 hours later - low grade fever, body aches, rash, itching, fatigue Ever since. (Today is the tenth day since the shot)

muscle soreness throughout body and at injection site, lethargy, slight headache - appears to be resolved after 1 day.

Nothing serious. Just an fyi. After shot my remaining shingles rash developed an increased sensitivity like a bad sunburn feeling. Tylenol works. Just wanted cdc to know a possible reaction sympton

Left shoulder injection site sore and tender. Stiff-tightness associated with movement. Hot shower directed at injection site reduced symptoms. Symptoms remain 48 hours after injection. I run at night, usually 3 miles or more. 7 hours after injection no problem running. 31 hours after injection running was much more difficult, similar to fatigue.

Slight soreness in left arm around and just below the point of injection. This went away around 6PM on Tuesday, the day after the injection. For about 2 hours around 10PM until I went to sleep on Monday night (the night of the injection), I had a slight fever but it was only slight. I had a more intense fever (though for only 30 minutes) the evening that I had my flu shot last October when I visited my doctor for a check up, so I would definitely categorize the fever from the COVID-19 shot as very slight. It was gone when I woke up in the morning. After I woke up, I was a bit nauseous, but it was so slight (and I have not been nauseous for well over a year) that it took me awhile to actually recognize it as being nauseous. This lasted for 15-20 minutes and then it disappeared. On Wednesday morning, my heart went into an irregular heartbeat that felt different than what I feel when it goes into an irregular heartbeat. I have no idea if there is any relation between receiving the vaccine and getting an irregular heartbeat but I thought I should report it. I have recovered from all symptoms from the vaccination except the irregular heartbeat. I put down as "unknown" if I have recovered from the adverse events as I don't know if going into an irregular heartbeat was in any way related to the vaccination.

2 erythematous nodules of flank; ipsilateral side of injection. initially tender, has been slowly improving. no drainage. Has a central punctum/scab.

Patient woke up at 10:00PM, out of a sound sleep, having an acute asthma attack and generalized itching. No rash. Used Albuterol inhaler twice, 5 minutes apart, and took Prednisone 20 mg orally. Within 60-90 minutes, symptoms completely resolved and did not reoccur. He did not seek medical attention at the time of this reaction, but called this office on 3/11/2021 so that the reaction could be documented. That prompted today's office visit and the completion of this VAERS form. Patient does have monthly allergy injections, but last injection was on 2/23/2021.

Three days after the second Pfizer vaccine, the patient developed generalized urticaria. This has slowly improved since it began, but the rash is still present.

This could be purely a coincidence, but 18 days ( on 03/07/2012) after my first injection on 02/17/2021 I started having some pain, burning and tingling under and around my right arm. Note the first injection was in the left arm. I saw my doctor 2 days later for a normally scheduled appointment. He said he thought I had aggravated a nerve and that i should get a Shingles vaccine as soon as I could after I finished the Covid Vaccine. I received the second dose on 03/11/2012 and then the day on 03/12/2021 i began breaking out with Shingles. Again this is probably purely a coincidence but I thought I should report it just in case.

First Dose: No arm soreness, but...extreme muscle, joint, neck, throat, headache, screaming ear noise, and body tension, and very sick...8 DAYS following the first injection. No fever, and vitals were OK. 800 mg Ibuprofen and Norco did not ease the pain. It was unbearable. Was tested for Covid and Strep, and both came back negative. I called my Primary Care physician and the local ER. All they said to do was to hydrate. Went to urgent cacre...no help. Lingering fatigue for another week. Finally after two weeks, the symptoms subsided. Second Dose. Same kind of pain on second day, but seems to be subsiding...so far. But, my injection site is very sore, swollen, and red. Does not seem to be getting better 5 days out.

COVID arm: macular-papular rash on anterior of L lore arm and ant tp elbow, tender sc nodules at injection site

Pt received vaccine and when needle pulled began bleeding small amount. Pressure held. Escorted to observ.ation. Noted on arrival to observation to have large hematoma around puncture site, Pressure held x 5 min. Ice pack applied. Upon questioning, stated that he took ASA daily. Held for 30 min observation. Advised to seek further advice from primary care physician. On final inspection, swelling had subsided. No redness noted

Sore arm at injection site for a couple of days. Developed a light red rash on the shoulder of the injection site 2 days after injection. Developed a ping pong ball size swelling under the right armpit 2 days after injection. Currently at day 8 and the rash and swelling have not yet subsided. There is some tenderness of the swelling if compressed by the arm in specific motions.

A couple of days after the vaccine, back muscle (upper back, left side- the same arm of vaccination) started hurting. Since then, the pain is constantly there BUT it moves to various locations, only on the left side, sometimes in muscles, sometimes in shoulder joint and often at the site of vaccination. The pain, while it moves around, is only at one location, often in addition to the vaccination site. Thus it can be in left shoulder joint and the site. Or it could be the site and at the shoulder- neck joint. Never has the pain migrated to the right side and is confined to the left arm, shoulder, upper back area. Naturally the pain dulls upon taking a couple of Tylenol?s or Advil?s but otherwise has been there no -stop for about two weeks, shortly after the vaccination. Avery slight swelling can be felt at the injection site.

Red bumps now in groups of 2-3 on my chest, back, arms, and legs. More accumulation 8 days later.; This is a spontaneous report from a contactable consumer, the patient. A 65-year-old male patient received the second dose of BNT162b2 ((PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot Number: Unknown), via an unspecified route of administration, in the left arm on 12Feb2021 (at the age of 65-years-old) for COVID19-immunization. The patient medical history included allergies to sulfa (sulfonamide antibiotics), and levofloxacin. 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's concomitant medications included: ibuprofen (ADVIL), paracetamol (TYLENOL), multivitamin, turmeric, and krill oil. The patient previously received the first dose of BNT162b2 on 22Jan2021 (Lot Number: Unknown; at the age of 65-year-old) for COVID-19 immunisation. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 13Feb2021, the patient experienced red bumps now in groups of 2-3 on my chest, back, arms, and legs. more accumulation 8 days later. No treatment was received for the adverse event. The patient had not recovered from the event, red bumps now in groups of 2-3 on my chest, back, arms, and legs. more accumulation 8 days later.

Extreme heat of head flushed , itching of chest and arms, rapid heart beat,, extreme nausea, coughing

Starting 4 days after second shot, I developed extensive rashes on multiple areas of my body. The rashes appear to be controlled by Benadryl. Also started taking Prednisone on 3/22/2021 at 12:30 PM. At this point (1:00 PM) I have taken 5 doses of Prednisone 10 mg each. The rashes subside within 2 hours of taking 2 tablets of Benadryl, but reappear around 5 hours of taking Benadryl. Rashes typically on same body parts, but in different areas. Rashes still present today.

After about 5 min of receiving his second Pfizer vaccine, pt suddenly developed generalized raise erythematous rash on arms legs, back . Hx: In anticipation onset of anaphylaxis, after appearance of rash on lt arm, pt put on stretcher , undressed immediately, and generalized rash noted. none pruritic. v/s and sat NORMAL. airway NORMAL. lungs clear. given pt's very concerning rash but lack of indication of impending anaphylaxis, given 50mg po benadryl. rescue called for trans and observation in ER where given 30mg prednisone po and monitored. was observed in ER and discharged after 2 hrs observation. 24 hrs later, pt continues to do well. Dx : acute allergic reaction to pfizer vaccine.

I don't know if it's related to vaccination or not, but I got an earache in left ear 3-days after vaccination. Ear and Face were swollen, warm to touch, painful and could not hear. I am still having difficulty hearing in that ear (3-25-2021), sounds like liquid in that ear. I called a tele doc service on Sunday, 02/14/2021, they prescribed Amoxicillin -Clav. Temperature and swelling went away, still having difficulty hearing in that ear.

injection site pain, headache, left ear ache, sore left eye. Ongoing on second day. Took 1 aspirin. Still have swollen lymph gland from first shot 3 weeks ago.

Developed widespread body-rash and/or hives eleven-days post COV-19 vaccination. Did not relate this to the vaccine at first due to time passed since the first shot. Treatment for rash is ongoing at the time of this report.

Relapse of Cellulitis, I have had Cellulitis twice before in the same leg, left. Hospitalized the first time, second time a course of Linezolid 600mg 10 days. On a course again finishing 02 Apr 2021

Infection after hernia surgery; respiratory infection; swelling was from the trauma of the procedure; pain; aggravates the arthritis; aggravates the psoriasis; stress; Felt like he was getting a cold; Little cough/He was not coughing up green or red, just light brown; Tired; This is a spontaneous report from a contactable consumer (patient). A 65-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), at same age, via an unspecified route of administration, administered in arm left on 09Feb2021 13:00 (Batch/Lot Number: EH9899) as single dose for covid-19 immunisation. Medical history included ongoing bronchitis chronic, pneumonia, ongoing back issues, which has been suffering from back issues for 20 years, ongoing psoriatic arthritis, ongoing psoriasis, liver transplant from 29Oct2013 to an unknown date, muscle spasms, heart rate, depression, anxiety attacks, blood pressure and hernia. Concomitant medication included amlodipine for blood pressure and ongoing and he began taking years ago, carvedilol for heart rate and ongoing that he began taking over 10 years ago and stated that it is to keep his heart rate between 70 and 80 beats per minute; pravastatin and ongoing that he began taking about 5 years ago; sertraline hydrochloride (ZOLOFT) for antidepression and ongoing that he has been taking for 2 or 3 years; alprazolam (XANAX) for anxiety attacks and ongoing that he has been taking for over 10 years; cyclobenzaprine hydrochloride (FLEXERIL [CYCLOBENZAPRINE HYDROCHLORIDE]) for he didn't cramp up and ongoing that he has been taking for 5-10 years; mycophenolate and everolimus both from 2013 and ongoing for anti-rejection since his liver transplant in 2013. While providing concomitant medications he mentioned details about a historical medication. He was on bupropion hydrochloride (WELLBUTRIN), but was switched to Zoloft. He was switched because he had built a resistance to the bupropion hydrochloride and had to move up in the class. The patient experienced tired on 10Feb2021, felt like he was getting a cold on Mar2021, little cough on Mar2021. The patient was hospitalized for infection after hernia surgery (infection) from 22Feb2021 to 24Feb2021. For chronic bronchitis, patient stated that he was never really diagnosed, that it's just like having a cough all the time. It felt like his lungs are not big enough for his body and that he got winded quickly. He was strong and could do manual labor, even after the liver transplant, but that he has noticed the last couple of years that the cold felt like it's freezing his skeleton. He has had pneumonia 3 times altogether. He was unable to specify dates but he knew that he had it post-transplant in 2013. There isn't a test for psoriatic arthritis so he was unable to provide a diagnosis date. He had been experiencing this for the last 10 years. He was diagnosed with psoriasis when he was 25. He had his first shot done, clarified as the Pfizer Covid-19 vaccine. He was supposed to go back to get his second dose of the Covid-19 vaccine but was hospitalized briefly after hernia surgery with complications and got an infection. Therefore, he didn't make his appointment. Patient stated that his second dose of the Covid-19 vaccine is now scheduled for 21Mar2021 but he would like to schedule it for somewhere closer. He was a liver transplant patient and that the hospital where he received the transplant likes to keep things in house. After the hernia surgery he couldn't drive or sit down because it was uncomfortable and that the jostling of the car was too much. Patient reported that he would see his physician who recently retired once a month for a prescription for pain meds that he needs for back issues, psoriatic arthritis, and scar tissue from being operated on 4 times. He has had about 10 Covid tests. It made people feel more comfortable when he shows them the negative results. He has been stressed over waiting for the Covid test, that the stress then aggravates the psoriasis which aggravates the arthritis. After the vaccine he clarified he did not feel right. He said that he didn't feel sick, just wasn't 100%. He was tired and felt like he was getting a cold after receiving his first dose of the Covid-19 vaccine. Which he did, he had a cold/cough. He felt tired the next day and only for a couple of days after. He confirmed the tired feeling has resolved completely. Patient stated that he thought the hernia surgery was already scheduled, and stated that the liver clinic called him and said that he had to come in a certain day at a certain time. He received the first dose of the Pfizer Covid-19 vaccine 4 days before surgery. For infection after hernia surgery, patient reported that he couldn't remember the hospital dates but that he was admitted for 2 days and received IV antibiotics. He was hospitalized on 22Feb2021 or 24Feb2021. His doctor had told him that the swelling was from the trauma of the procedure. For little cough and felt like he was getting a cold, patient reported that he had been on oral antibiotics after his surgery and his doctor increased the dosage to help with the respiratory infection, it was a cough. Feeling like getting a cold started like a week ago. He was not coughing up green or red, just light brown. Patient unable to provide NDC number or expiration date as they were not listed on his card. He was a liver transplant patient so he's on immunosuppressants. He stated that he is 65 and if he gets Covid he's a dead pigeon and that he doesn't see himself surviving the pulmonary aspect. Mentioned he has had pneumonia a few times in his life, post transplant, and has bronchitis. Patient stated that Micophenylate/ Everlimus were actually poison that fool body into thinking that's liver. Caller stated that they lower immune system so didn't fight it. He got more colds and if he got a cut on hand it would get infected. Patient stated that he had labs done and a CT scan and labs when he was hospitalized for the infection after his hernia surgery and that everything came back normal. He was just having pain. Vaccine administered was not at facility and vaccination facility type was hospital. Nonadditional administered vaccines. No AEs require a visit to emergency room but physician office was required. He went to the doctor for the little cough that he experienced. He was hospitalized for the infection following his hernia surgery. Patient hospitalized for 2 days was the hospital stay. No prior vaccinations within 4 weeks and no ae following prior vaccinations. The outcome of event tired was recovered on unspecified date in 2021 (as reported), the outcomes of events felt like he was getting a cold and little cough were recovering, while other events were unknown.

Immunization 3/29/2021 COVID Vaccine Clinic Need for vaccination +1 more Dx Referred by MD Reason for Visit Progress Notes APRN (Nurse Practitioner) ? ? Family Medicine Cosigned by: MD at 3/30/2021 8:12 AM Expand AllCollapse All COVID VACCINE CLINIC 3/29/2021 Patient: (name) DOB: (date) Date: 3/29/2021 MRN: (number) Subjective Patient is a 65 y.o. male who was seen at the COVID Vaccine Clinic today for his second dose of the COVID 19 vaccination. He was given the Pfizer vaccination in the left deltoid muscle. During his 15 minute waiting period after the injection, the patient began to experience shortness of breath as he was walking out to the front. He reports no issues with the vaccine as he was waiting. He denied rash, hives, welts, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, lightheadedness, dizziness, facial swelling, lip swelling and tongue swelling. This provider was notified of patient reaction and he was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to blood pressure abnormality , chest pain, rapid progression of symptoms and respiratory distress. Pmh: hx of iron deficient anemia. He just stopped taking his iron supplements on Saturday after being on it for 10 days. He also was taking Diflucan and had some "adverse reaction" of nausea and sleeping issues. Denies hx of heart or lung disease, not on any inhalers or medications for these. Past Medical History: Diagnosis Date ? Fatigue, unspecified type 2/7/2017 ? Impotence of organic origin Impotence, Organic; NG PMH ? Obstructive sleep apnea ? Osteoarthritis ? Unspecified essential hypertension Hypertension; NG PMH ALLERGY REVIEW OF SYSTEMS: Patient complains of shortness of breath Patient denies chills, fever, malaise/fatigue, facial swelling, sore throat, frequent throat clearing, eyes watering, eyes itching, cough, chest tightness, wheezing, rash, hives, itching of skin, vomiting, abdominal pain, muscle aches, joint pain, dizziness and headaches Previous Reactions: none Objective Vitals Vitals: 03/29/21 1035 BP: 138/58 Pulse: (!) 102 SpO2: 92% Physical Exam Vitals reviewed. Constitutional: General: He is not in acute distress. Appearance: He is not ill-appearing or diaphoretic. HENT: Mouth/Throat: Mouth: Mucous membranes are moist. Pharynx: Oropharynx is clear. Eyes: Extraocular Movements: Extraocular movements intact. Conjunctiva/sclera: Conjunctivae normal. Pupils: Pupils are equal, round, and reactive to light. Cardiovascular: Rate and Rhythm: Regular rhythm. Tachycardia present. Heart sounds: Normal heart sounds. Comments: HR improved with rest down to 90 Pulmonary: Effort: Pulmonary effort is normal. Breath sounds: Normal breath sounds and air entry. Comments: Speaking full sentences. Skin: General: Skin is warm. Coloration: Skin is not pale. Findings: No rash. Neurological: General: No focal deficit present. Mental Status: He is alert and oriented to person, place, and time. Psychiatric: Mood and Affect: Mood normal. Thought Content: Thought content normal. Judgment: Judgment normal. Assessment/Plan Treatment included: no therapy Follow up response to treatment: excellent. Patient discharge: Stable to go home and follow up with PCP. Differential Diagnosis: Systemic reaction (headache, itching, tachycardia, hypoglycemia, hypotension, generalized rash) Pt with improvement/resolution of sob with rest. I suspect sob related to iron deficiency. Recommend that he monitor breathing at home . If symptoms return or Worsen, seek care in ED. Certainly to follow up with pcp accordingly for management of his iron levels. Pt voiced appreciation and denies any other questions or concerns. (name), APRN Electronically Signed 3/29/2021 10:42 AM

Patient c/o dizziness, blurred vision. Skin hot to touch. Vital signs: 11:25am 130/76 81 18; 11:26am 120/82 80 18; 11:31am 130/79 75 18 O2 96% Temp. 97.2 11:41am 127/72 69 18 O2 97%; 11:48AM 130/90; 11:55am 132/84 70 18 O2 98%

day 7 queasy stomach after eating breakfast, lasted all day. Day 10 intense itching all over skin, continued for duration. Day 12 Diarrhea 10-20 minutes apart for 5 days. GI tract slowed or stopped for 48 hrs, continued eating, Vomited @ 48 hours and diarrhea again for 2 days, GI tract slowed for 2 days, Vomited and Diarrhea for 8 hours, GI tract slowed, when the full feeling was there this time I fasted and exercised until there was pressure relieved by constipated bowel movement. My GI tract seems to be flipping from purging and slow down. The itchy skin subsided more or less as the GI tract stopped purging. as of April 5 my GI tract seems to have settled into a mild constipated state, not it?s normal.

1 vial of undiluted Pfizer-BioNTech Covid-19 Vaccine was administered to the patient. Patient was assess 30 minutes later, denies allergic reaction. A follow up call an hour later, to inform the patient of 1 vial undiluted vaccine given to the patient, denies pain or allergic reaction, Patient was told to go to the Hospital if not feeling well. Another follow up call 2x in the afternoon and patient denies allergic reaction. Another follow up call 4/7/21 AM and PM, patient still denies allergic reaction to the Covid vaccine but sour to the injected site.

Extreme fatigue, sleeplessness, body aches, sore arm where vaccination given. Lasted three days so far. Some relief with Tylenol

Small red bumps on left arm the first day on Sunday the April 3rd. Then on Next day slight swollen red bumps covering chest and abdomen and right arm. Then next day after taking Benadryl more red bumps on face and neck slightly swollen. No problem breathing or other symptoms. It is the 8th of April still taking Benadryl and bumps haven?t gone away. Did call Dr. office and spoke with pharmacist. We?re told to take Benadryl. If not better by tomorrow will go to urgent Care.

Pain at injection site; lightheadedness/dizzy; lethargic; This is a spontaneous report from a contactable consumer (patient). A 65-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Right on 25Mar2021 12:15 (Batch/Lot Number: UNKNOWN) at the age of 65-years-old as single dose for covid-19 immunisation. The COVID-19 vaccine was administered at Public Health Clinic. Medical history included Peanut oil allergy. Concomitant medications included lisinopril taken for an unspecified indication, start and stop date were not reported; rosuvastatin taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient took the first dose of bnt162b2 for covid-19 immunization on 04Mar2021 12:15 PM at Left arm. The patient experienced pain at injection site, lightheadedness/dizzy, lethargic on 26Mar2021 10:30. No treatment received for the events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the events recovering. Information on the lot/batch number has been requested.

Headache; body ache; fever; soreness at site of injection; This is a spontaneous report from a contactable consumer. A 65-years-old male patient received first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection) via an unspecified route of administration in Arm Left on 20Feb2021 at 11:30 (Lot Number: EN6203) as single dose for covid-19 immunisation. Medical history and concomitant medications were not reported. On 20Feb2021 at 17:00, the patient experienced headache, body ache, fever, soreness at site of injection. Patient did not test for covid post vaccination and did not received Other medications in two weeks, other vaccine in four weeks. The patient was recovering from the events. No follow-up attempts are needed. Further information not expected.

Whole body rash with itchy bumps started 2 weeks after the second vaccine shot. Ointments and creams mitigate the itch for a few hours. Rash continues to this day.

patient had swelling at the injection site. patient was given ice pack. The patient swelling went down. Patient left smiling. Patient wanted second covid vaccination.

Rash. Initially in right arm. Later extended through legs chest and back; This is a spontaneous report from a contactable consumer (Patient). A 65-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in Arm Right on 20Feb2021 14:30 (At the age of 65-year-old) as single dose for covid-19 immunisation. Medical history included HTA, cholesterol. No allergies reported. The patient's concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, was the patient was not diagnosed with COVID-19. Since the vaccination, has the patient been tot been tested for COVID-19. On 20Feb2021 16:30, the patient experienced rash, initially in right arm. later extended through legs chest and back. Seriousness criteria reported as non-serious. Therapeutic measures were taken which included Allegra. The outcome of event was recovering. Information on the lot/batch number has been requested.

Soreness in injection site shoulder; slight body aches; headache; Felt like a cold coming on.; This is a spontaneous report from a contactable consumer (patient) via COVAES. A 65-years-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EP6955), via an unspecified route of administration on arm left on 27Mar2021 at 11:30 am as single dose for COVID-19 immunisation. Medical history included hypertension, depression and attention deficit hyperactivity disorder (ADD). Concomitant medications the patient received within 2 weeks of vaccination included venlafaxine; losartan; amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) and hydrochlorothiazide. Previously, he had first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6202), via an unspecified route of administration, in arm left on 06Mar2021 at 02:00 pm as single dose for COVID-19 immunisation. On 27Mar2021, he received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at 11:30. The patient experienced soreness in injection site shoulder on, slight body aches, headache and felt like a cold coming on at 03:00 pm on 27Mar2021. No treatment was received for the reported events. Outcome of all events was recovered. No follow-up attempts are needed. No further information is expected.

Zoster like lesions on Left Low back and Left Anterior and lateral thigh. mildly pruritic and mildly uncomfortable. no other systemic symptoms

While in monitoring room client noticed red blotches on arms. No other signs or symptoms noted. b/p 168/98 patient reported that it would be high before b/p was taken, stated he has high blood pressure. PSO2 97 % pulse 59. Skin pink warm and dry. Respirations even and unlabored. Client monitored until 2pm, stated he was going to see his friend who is an ER doctor for a follow up. Informed to seek medical attention if any other symptoms or shortness of breath occurred at any time.

About a month after my second Pfizer Covid-19 vaccine I experienced an episode of hives. Since then, I have had four other hives events. My skin turns very red, my skin feels hot internally, and it is somewhat itchy. It resolves itself after 45-75 minutes. It does happen after I eat something. But, I have not been able to determine which if any food is the cause. And all of the foods that I'm consuming I have for quite some time. For example, I have been eating dark chocolate almost daily for many years without a problem. Last week, I hadn't eaten for several hours. When I returned to my car , I ate a small piece of dark chocolate, and soon after I experienced a hives event. I have never ever had hives in my life so I am assuming that it is an immune response resulting from the vaccine.

Red splotchy rash and arm sore, area with rash irritated and sore. Began 2 days post injection. has continued on 4/20/2021

bad psoriasis; This is a spontaneous report from a contactable consumer (patient). A 65-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 06Feb2021 at 01:30 AM as single dose for COVID-19 immunization in Health Clinic. Medical history included allergies to mushrooms. The patient's concomitant medications were not reported. No other vaccine in four weeks. No other medications in two weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. On 10Feb2021 at 02:00 AM patient experienced bad psoriasis and received treatment. The event resulted in Doctor or other healthcare professional office/clinic visit, disability or permanent damage. Post to vaccination, patient was not tested for COVID-19. Outcome of the event was not recovered. No follow-up attempts are possible. No further information is expected.

Per pt's caregiver, he had chills, hives, itching, fatigue, swollen joints, an irregular EKG and PVC (premature vascular contractions). The irregular EKG & PVC is what I wanted to report since this is not considered typical with the Pfizer vaccine.

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

Sore arm, headache, and fatigue starting 6 hour after shot and lasting about 30 hours. Bilateral rash and itching on chest and upper back starting one day after shot

Fever up to 102 degrees; muscle pain all over; Chills; sweats; Headache; tiredness; feeling unwell; injection site soreness; This is a spontaneous report from a contactable consumer (Patient). A 65-year-old male patient received a first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EN 62 OV, expiry date 30Jun2021) at right arm via an unspecified route of administration, on 20Feb2021, 11:45 at SINGLE DOSE for COVID-19 immunization. Patient was diagnosed with COVID-19 Prior to receiving vaccination. The concomitant medications were not reported. On 21Feb2021, the patient experienced fever up to 102 degrees, muscle pain all over, chills, sweats, headache, injection site soreness, tiredness, feeling unwell. Since the vaccination, the patient not been tested for COVID-19. It was reported that the patient not received treatment for the events. At the time of this report event outcome was recovering.

itching at injection site; swelling at injection site; injection site warm to touch; This is a spontaneous report from a contactable consumer (patient). A 65-year-old male patient received bnt162b2 (BNT162B2 Formulation: Solution for injection, Batch/Lot number: EN6198, Expiry Date: 30Jun2021), on left arm at the age of 65, dose 2 via an unspecified route of administration on 20Feb2021 as single dose, dose 1 (Lot EL9266, Expiry: 31May2021) via an unspecified route of administration on 30Jan2021 as single dose for covid-19 immunization. Vaccination Facility was Physician Office Hospital. Medical history included diabetes for which patient takes unspecified high blood pressure medication. Concomitant medication was Januvia for diabetes. On 23Feb2021 the patient experienced itching at injection site, swelling at injection site, injection site warm to touch. It was reported should he seek further treatment or advice. The adverse events does not require physician office visit and emergency room visit. The patient did not receive any other vaccines within 4 weeks prior to the covid-19 vaccine. Patient was not administered any vaccine on same date of the suspect. Outcome of reaction/event at the time of last observation was not recovered/not resolved.

ADR covid vaccine monitoring documentation. Patient seen in the ED 4/25/21 diagnosed with shingles. PT documented to have painful rash at the back of the neck noted to be shingles. The patient indicated they received first dose of Pfizer COVID-19 vaccine Lot EW0158 on 4/21/21 (3 days prior to arrival).

I know that it is common for your arm to be sore for a day or two, but my arm was very sore for at least two weeks and it is now 4 weeks and 2 days since the shot and my arm is still somewhat sore.

fever; Aches and pains all over body; Right arm soreness at injection site; Severe chills; too tired and too chilled; This is a spontaneous report from a contactable consumer (patient) via Medical information team. A male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EW0158, Expiration date: 31Jul2021), via an unspecified route of administration in right arm on 13Apr2021 at 10:45 at single dose for COVID-19 immunization. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: ER2613, Expiration date: 31Jul2021), via intramuscular route of administration in left arm on 23Mar2021 at 11:45 am as single dose for COVID-19 immunization. The patient's medical history included diagnosed on Jul2016, colonoscopy on 07Apr2021. Patient had no family history. The patient concomitant medications included supplements. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Patient had no additional vaccines administered on same date of the suspect vaccine. The patient stated he had no reaction to the first dose of the vaccine and after the second dose on tuesday (13Apr2021 at 21:00) and had chills when he went to bed that night. He went to bed that night with severe chills. On 14Apr2021 at 09:00, the next morning, he had a fever of 101 and aches and pains all over his body. Earlier, about a half hour before shot, he had a COVID test because he had a procedure today to give birth to a kidney stone which was cancelled due to fever aches and pains. He previously had COVID test and they all came ack negative. The procedure had to be cancelled. Today, he went back in to get another COVID test. He will know results within a couple of hours or before tomorrow whether it comes back positive or not. He does not believe the vaccine gave him COVID, but will find out when the test is tomorrow. He asked if the second dose is the same as the first dose. He said he has been reading and it is essentially the same but depends on the person that dilutes it and the temperature it is at. After verbal response he stated the second shot was definitely building a strong immune response. It was reported that first shot primes the immune system, helping it recognize the virus, and the second shot strengthens the immune response. Chills were gone by wednesday gone but still had a fever and aches and pains. He was too tired and too chilled to take his temperature tuesday night. He has a hazardous material thermometer. He called his urologist that night and said he may need to reschedule procedure tomorrow which is today. The fever improved during day but at night it crept back up to 101 and this morning is 98. His pulse ox is 98%. This morning other than feeling stiff for sleeping 16 hours, he has a couple of aches and pains this morning, but they are gone now. He was diagnosed with this kidney stone for 4 years. It is a bladder stone and his urologist said it is a nuisance stone. Once he got where insurance would cover it, he said lets take care of it. It was diagnosed Jul2016 and it was prescheduled to get it removed. Patient had a colonoscopy that was prescheduled. It was 15 years since he had one. He kind of wondered if the doses are different. He wanted to know if the second dose was a little more powerful. He takes supplements but does not think any would be relevant. Taking same supplement with first dose. The patient underwent lab tests and procedures which included SARS-CoV-2 test: negative on 23Sep2020, 05Apr2021 before Colonoscopy and last test was 13Apr2021 two days prior to when he was going to have kidney stone removed. He had an additional one done today and does not have results yet. The outcome of the event fever was recovering, too tired was unknown and rest all events was recovered on 2021. No follow-up attempts are needed. No further information is expected.

Developed a severe case of shingles on my right side a day or two after receiving the second Pfizer exam. The pain, etc., has lasted for over a month although things have subsided significantly over the past week. I am a strong advocate for vaccinations and understand this may be a coincidence, but the timing does seem a bit suspicious and that's why I am reporting it.

Shingles outbreak 17 days after 2nd dose. Never had shingles before. Did have the old single dose shingles vaccine ago

I felt burning sensation as I was being injected with the 2nd dose of the Pfizer vaccine. I noticed that, the strength of the burning sensation corresponded to the amount being injected into my arm. I asked the person administering the shit, whose name I was told , why did it burn and didn?t burn when I had the first dose of the same vaccine? Her answer while she was smiling: ?it is the alcohol I rubbed prior to the injection. Her answer didn?t make sense to me since the burning I felt was not at the same level but rather depended on how much vaccine was being injected. As such it is either the vaccine that caused the burning or the method of injection used, not the claimed ?alcohol? . The burning dissipated minutes afterwards, and so far I do not show any other symptoms., I do however feel concerned if what I was injected with caused the burning sensation I felt.

On about April 28 give or take a day, I noticed a small red soar like an irritated ugly mean sore not open but threatening like. I got the vaccine in the right arm but these are all in the left lower middle arm. Then two more. This went on for a week and then I started to put rubbing alcohol and in the last 3 days I put Antiseptic Iodine solution 10% Now today I have about four more, total about 7 or 8. They are redish and appear to have flesh raw like around the middle. They are about 1/16 to 1/8 inch in size. It is scary and they dont go away and nothing seems to help get rid of them. I dont know if I should get the 2nd vaccine as is to be done this friday.

I broke out whit little bumps; I am itchy all over; Last night it was so bad it was burning; This is a spontaneous report from a contactable consumer (patient). A 65-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Formulation: Solution for injection) via an unspecified route of administration as single dose for covid-19 immunisation. Medical history included covid-19, patient had Covid back in December at Christmas time. Concomitant medication was not reported. On an unspecified date the patient experienced broke out with little bumps and experienced itchy all over, and last night it was so bad it was burning. Second dose was scheduled on 15, patient stated it is not contraindicated to receive the second dose based on his reaction. Therapeutic measures were taken by taking Benadryl which helping a little bit. The outcome of the events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

severe pain at injection site; shallow breathing; This is a spontaneous report from a contactable consumer (patient). A 65-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch/Lot Number: E13302), via an unspecified route of administration, administered in left arm on 10Feb2021 at 10:00 (at the age of 65-years-old) as single dose for COVID-19 immunisation. The facility type vaccine was hospital. The patient did not received other vaccine in four weeks. Medical history included cancer, COPD and penicillin allergy. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medications included clopidogrel bisulfate (PLAVIX), metoprolol, atorvastatin and gabapentin, all taken for an unspecified indication, start and stop date were not reported. On 10Feb2021 the patient experienced severe pain at injection site and shallow breathing. The patient did not receive treatment for events. The outcome of events was not recovered.

Fainting,pain,itching,fatigue,headache,nausea, Lost of smell, short term memory off and on,; Fainting,pain,itching,fatigue,headache,nausea, Lost of smell, short term memory off and on,; Fainting,pain,itching,fatigue,headache,nausea, Lost of smell, short term memory off and on,; Fainting,pain,itching,fatigue,headache,nausea, Lost of smell, short term memory off and on,; Fainting,pain,itching,fatigue,headache,nausea, Lost of smell, short term memory off and on,; Fainting,pain,itching,fatigue,headache,nausea, Lost of smell, short term memory off and on,; Fainting,pain,itching,fatigue,headache,nausea, Lost of smell, short term memory off and on,; Fainting,pain,itching,fatigue,headache,nausea, Lost of smell, short term memory off and on,; This is a spontaneous report from a contactable consumer (patient). A 65-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 29Apr2021 12:45 PM at the age of 65-years-old (Batch/Lot Number: Unknown) as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included Herniated discs L4,L5,S1,C4,C5C6C7, type 2 diabetes from an unknown date. Concomitant medications included apixaban (ELIQUIS); dipyridamole (METROPOLYN) and bupropion, all taken for an unspecified indication, start and stop date were not reported. The patient previously took lidocaine and experienced allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 29Apr2021 01:15 PM, the patient experienced Fainting, pain, itching, fatigue, headache, nausea, Lost of smell, short term memory off and on. It was unknown if treatment received. The outcome of the events was resolving. Information on the lot/batch number has been requested.

massive itching; There is resolutions till date its painfull itching sleep interupted.; red rashes all over body and face swollen/red rashes erruptions.; face swollen/worsen with swelling; This is a spontaneous report from a contactable consumer (patient). A 65-year-old male patient received he second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot Number: ER8731), via an unspecified route of administration at the age of 65-year-old at arm Left on 14Apr2021 14:30 at single dose for COVID-19 immunization. Medical history was reported as no illness ever before, Prior to vaccination, the patient wasn't diagnosed with COVID-19. Concomitant medications were not reported. There were no other medications the patient received within 2 weeks of vaccination. The patient previously received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number: EP7534) at the age of 65-year-old at left arm on 26Mar2021 01:15 PM for COVID-19 immunisation. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Facility where the most recent COVID-19 vaccine was administered in pharmacy or drug store. Since the vaccination, the patient hasn't been tested for COVID-19. In 8 hours of receiving vaccin second shot on Friday (as reported) red rashes all over body and face swollen on 14Apr2021. Went to Urgent care on Saturday (as reported) the hospital on Sunday (as reported) as situation worsen with swelling and massive itching and red rashes erruptions on 17Apr2021 12:00. There was resolutions till date its painfull itching sleep interrupted on 17Apr2021 12:00, over two weeks now. The patient was hospitalized for one day for events. The adverse event result in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The patient received treatment (steroid intravenous then oral till date) for the adverse event. The outcome of events was not recovered.

Left arm swelling with hive; Left arm swelling with hive; left hand fingers numb; Fever; headache; Right Arm tingling; This is a spontaneous report from a contactable consumer reporting for himself. A 65-years-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 11Feb2021 14:00 (Batch/Lot Number: EL9267) at the age of 65 years as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included colectomy Colon resection 14 years ago. The patient's concomitant medications were not reported. On 11Feb2021 22:00 the patient experienced left arm swelling with hive, left hand fingers numb, fever, headache, right arm tingling all with outcome of not recovered. Therapeutic treatment: Tylenol. No follow up attempts are possible. No further information is expected.

Patient received vaccine on tuesday 5/4. Patient developed a rash surrounding both ankles. Patient and wife dismissed this as possible side effect of vaccine. The patient had difficulty breathing and dismissed it as a panic attack on 5/10. Symptoms continued for several days, went to walk-in clinic on Wednesday 5/12 for tests and inconclusive. Thursday 5/13 the patient continued to experience these symptoms and elevated pain, tightness and cramping in legs and went to the ER where he was diagnosed with bilateral pulmonary emboli. Patient was admitted for 2 days and treated for clots. Upon discharge the patient was instructed to discontiue meloxicam, carbidopa/levodopa and started on eliquis for 6 months. After 6 months the patient will follow-up with a hemotologist.

itching; having a rash; This is a spontaneous report from a contactable 65-year-old male consumer reported for himself that he received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number; unknown, unable to locate or read the details) via an unspecified route of administration on 25Jan2021 at 02:00 pm at 1st dose, single on left arm for covid-19 immunisation. Patient was 6years-old at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered was reported as Doctor's office/urgent care. Patient's medical history was not reported; Allergies to medications, food, or other products was reported as none that i am aware of. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Patient's concomitant medications (other medications the patient received within 2 weeks of vaccination) included atorvastatin, metformin and lisinopril (dates, indication and dosage unspecified). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced itching and having a rash starting on 25Jan2021. The reported events were not considered as serious and did not fall under any seriousness criteria. No treatment was received for the adverse events. On follow-up received on 16Apr2021, it was reported that the lot/batch number is not available despite the follow-up attempts made. The outcome of events was not recovered. Follow-up attempts have been completed and no further information is expected.

Rash on upper right arm and shoulder( Opposite injection Site).; Muscle pain; This is a spontaneous report from a contactable consumer, the patient. A 65-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration on his left arm on 05Mar2021 at 15:15 (at the age of 65-years-old), as a single dose for COVID-19 immunisation. Medical history included peripheral arterial disease (PAD), chronic obstructive pulmonary disease (COPD) and hypertension. Concomitant medications included atorvastatin (MANUFACTURER UNKNOWN), clopidogrel (MANUFACTURER UNKNOWN), lisinopril (MANUFACTURER UNKNOWN), and metoprolol (MANUFACTURER UNKNOWN); all for unknown indications form unknown dates and unknown if ongoing. Patient was allergic to pseudoephedrine hydrochloride (SUDAFED). 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. One week after vaccination on 12Mar2021 at 06:00, the patient experienced rash on upper right arm and shoulder (opposite the vaccination site). It started as muscle pain, which was not itchy. It was just uncomfortable muscular pain. He did not receive treatment for the events. The clinical outcomes of the rash and muscular pain were not recovered at the time of report. No follow-up attempts are needed. No further information is expected.

Pfizer-BIONTECH COVID-19 vaccine EUA . I broke out in a fast spreading rash that started out as a few small spots on my arms and legs and 8 hours later it completely covered my arms, legs, and waist. I called a nurse who told me I was having a allergic reaction and to go to the emergency room where I was given steroids to clear up the rash. Two days later the rash was gone.

Achy body; Soreness at injection site; This is a spontaneous report from a contactable consumer (patient himself). A 65-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3248), via an unspecified route of administration on 26Jan2021 at 09:00 am on the right arm as unknown, single for COVID-19 immunization. Patient's medical history included Stroke, Allergy to Lisinopril and Latex allergy at an unspecified date. Patient's concomitant medications were not reported. 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, the patient had not been tested for COVID-19. Concomitant medications include Aspirin (325mg), Atorvistatin, Flomax and Famotadine at an unspecified start and stop date. On 27Jan2021 at 10:00 pm, the patient experienced Soreness at injection site after 36 hours of vaccination and 48 hours post injection experienced achy body. Patient confirmed that he had no fever. Treatment was received with Tylenol. The outcome of the events was recovered. Follow-up attempts are completed. No further information is expected.

Covid arm. red blotchy arm on arm that had shot; This is a spontaneous report from a non-contactable consumer (patient). A 65-year-old male patient received BNT162B2 (PFIZER COVID-19 VACCINE, lot number: unknown), at the age of 65 years old, at single dose on 15May2021 13:45 for covid-19 immunisation. The patient had no known allergies. The patient was not diagnosed with covid-19 prior to vaccination. The patient experienced covid arm, red blotchy arm on arm that had shot on an unspecified date. The patient had not been tested for covid-19 since the vaccination. No treatment was received. The outcome of events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

5-10 minutes after injection, I noticed a small, itchy bump on my forehead-it feels like a tiny hive; the itching mostly subsided after an hour or so.I had no definite symptoms, but did feel a bit of rash around same time; This is a spontaneous report from a contactable consumer (patient). This 65-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, Batch/Lot Number: EN6199), via an unspecified route of administration, in left arm on 07Mar2021 18:30 (at the age 65 years) as single dose for covid-19 immunisation. Medical history included irritable bowel syndrome, possible pityriasis lichenoides, respiratory allergy (many respiratory allergies, some of them severe), skin tests for food allergies (had strong reactions to many food, sunclear whether those are allergies), ragweed allergy (treated for years & a few times had strong reactions to those shots (not anaphylaxis)). Concomitant medications included montelukast; budesonide (NASOCORT) and cetirizine. It was reported that 5-10 minutes after injection, on 07Mar2021 18:45 patient noticed a small, itchy bump on my forehead -it felt like a tiny hive. The itching mostly subsided after an hour or so. Patient had no other definite symptoms but did feel a bit of a rush (maybe like feel when he take sudafed) around the same time. The clinical outcome of the events was resolved on an unknown date. No follow-up attempts are possible. No further information is expected.

Rash on eyelids and arms after 2nd Pfizer COVID vaccine; Rash on eyelids and arms after 2nd Pfizer COVID vaccine; This is a spontaneous report from a contactable consumer via Pfizer sales representative. This consumer (patient's friend) reported for a 65-year-old-male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Solution for injection, Lot number: not reported), dose2 via unspecified route of administration, on an unspecified date (at the age of 65-years-old) as single dose for COVID-19 immunization. Patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Solution for injection, Lot number: not reported), via unspecified route of administration, on an unspecified date, at a single dose for COVID-19 immunization. The patient's medical history included leukemia as a child and had not had a reaction to a vaccine before. Patient's concomitant medications were not reported. On an unspecified date, the patient experienced rash on eyelids and arms after 2nd Pfizer COVID vaccine. He had been to allergist who provided a steroid cream for arm and said not to put on eyelids. The reporter stated that this occurred close to 3 months ago and still has not resolved. He has a dermatologist appointment on 03Jun2021. The outcome of events was not recovered. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Skin rash over right upper thigh and buttocks; This is a spontaneous report from a contactable male consumer (patient). A 65-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EN6200, and Expiration date: Unknown), via an unspecified route of administration, administered in right arm on 23Feb2021 10:30 (at the age of 65-year-old) as 1st dose, single for COVID-19 immunization at public health clinic/veterans administration facility. The patient medical history was not reported. The concomitant medications included atenolol (ATENOLOL), simvastatin (SIMVASTATIN, lisinopril (LISINOPRIL), and hydrochlorothiazide (HYDROCHLOROTHIAZIDE). The patient had no allergies. 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 27Feb2021 14:00, the patient experienced skin rash over right upper thigh and buttocks. The patient did not receive any treatment for the event. The outcome of the event was not resolved. No follow-up attempts are needed. No further information is expected.

Site soreness; Generalized muscle soreness; This is a spontaneous reporter from a contactable consumer. A 65-year-old male consumer (patient) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EN6201) via an unspecified route of administration on 04Mar2021 at 01:15 PM (age at vaccination: 65 years ) on left arm at single dose for COVID-19 immunization. The patient's medical history included hypersensitivity(allergies) to sulfa drugs. 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. It was reported that patient received other unspecified vaccine in four weeks but did not receive other medications in two weeks. On 05Mar2021, the patient experienced site soreness and generalized muscle soreness. No treatment was received for the events. The outcome of events was resolving. No follow-up attempts were possible. No further information was expected.

immune system was messed up and weak/overreacting immune system; could not go half way without sitting down; started having flaking to the hair and leg; immune system was messed up and weak; he stated that his eyes were getting worse; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer or other non hcp (patient) of 65-years-old male patient received BNT162B2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, formulation; solution for injection, lot number/Expiration date: not reported) via an unspecified route of administration, administered in Arm Left on 15Mar2021 (Age at Time of Vaccination, 65 years) at Afternoon as 2ND DOSE, SINGLE DOSE for covid-19 immunisation. patient took Covid Vaccine As soon as he could get it, 65 years and up. Medical history included hair texture abnormal from an unknown date and unknown if ongoing, rash macular from an unknown date and unknown if ongoing , psoriasis from an unknown date and unknown if ongoing , eye disorder from an unknown date and unknown if ongoing Scalia which affected eyes , ongoing diabetes mellitus Started 2 Years Ago , gastroenteritis viral from an unknown date and unknown if ongoing , skin disorder from an unknown date and unknown if ongoing , immune system disorder from an unknown date and unknown if ongoing. Concomitant medication included prednisone (PREDNISONE) taken for eye disorder, start and stop date were not reported. Patient stated that he started taking the steroid, Prednisone after the first vaccine and had the second vaccine before he was finished with the Prednisone, he was taking 80mg and then as it became the month after that they reduced it and weaned him off the steroid. No Additional Vaccines Administered on Same Date of the Pfizer Suspect. Family Medical History Relevant to AE was None. Relevant Tests were None. No medications were taken within 4 weeks, Prior to Vaccinations. No prior vaccinations following AE. Consumer said that before he received the 1st dose of the Pfizer-BioNTech Covid-19 Vaccine, he had a skin disorder which included flakiness of the hair, red blotches on his face, and psoriasis on both of his legs. He also said he had scalia, which affected his eyes. He said both of his eye doctors told him that his condition was because of an overacting immune system. He said his condition was getting worse every month. With that, he was given steroids which helped clear up his skin disorder and patient received historical vaccine bnt162b2 on 08feb2021 for covid-19 immunisation. However, he said he received the 2nd dose even before he was finished with his steroid medication. On Mar2021, the patient said at the time he received his 2nd dose, his immune system was "messed up" and weak. He added that he could not go half-way without sitting down. Patient said it took a while for him to build back his immune system but said that it was fine now. Patient said he had this skin disorder before he received either dose of the vaccine and he had no adverse events from the vaccine, his arm didn't even hurt. He wanted to make sure that he still had an immune response to the vaccine, since his immune system was so screwed up and it took so long for him to get healed up. Caller also clarified that the vaccine did not make his skin disorder worse. Caller states with his immune system so screwed up the way it was, the eye doctor said was sounded like an over-active immune system and so doctor gave him steroids and it cleared up the disorder within 2 weeks, well not completely but it was better. Patient had a skin disorders before receiving the vaccine, after receiving both doses his skin disorder started getting worse. He started having flaking to the hair and leg and also, he stated that his eyes were getting worse. The Doctor he saw have told him that it was because he had an overactive immune system. Now he was confused and wanted to know if he had immunity over Covid-19 or if the vaccine even worked since he had an overactive immune system and wanted to know if the vaccine was still effective on him. Patient stated he went to the clinic for his primary care, stated Pfizer can contact them but they are going to deny it because one time he had the stomach virus and they told him to take a test and the test came back negative. Patient was not admitted to Emergency Room or Physician Office. Outcome of the events was unknown. Follow-up (28Mar2021): This is a follow up-spontaneous report from a contactable consumer. New information included suspect details, Concomitant medication, Clinical information. Follow-up (28May2021): This is a follow-up spontaneous report from a Pfizer sponsored program. New information included confirmation of emergency room and physician room visit. Further information requested.

lost a few pounds; Stomach pain; Vomited; Loss of appetite; Feels like he is in a fog; Twitching in left ankle; Injection site pain left arm; feeling very unwell; Headache; very tired; Feverish; Chills; This is a spontaneous report from a contactable consumer (patient). A 65-years-old male patient received first dose of bnt162b2 (Pfizer-BioNTech Covid-19 Vaccine, Formulation: Solution for injection, Lot number: EW0177), via intramuscular route, in left arm on 27May2021 at 16:25 (at age of 65 years) as 1ST DOSE, SINGLE DOSE for covid-19 immunisation. Medical history included cancer (family medical history), cholesterol, blood pressure and heart attack from an unknown date and his father had heart attack in his 50's but he chain smokes. AE(s) following prior vaccinations: When he was 16, he got the flu shot and got severely sick. The patient concomitant medications were not reported. Patient received the first shot on 27May2021. The next day on 28May2021, he had all the symptoms such as injection site pain, very tired, headache, chills, Feverish, feeling very unwell. The next day on 29May2021, it seemed like he was fine. Now, ever since then, all he wanted to do was lay down. He doesn't feel well. He had stomach pain. He was kind of in a fog. He just wanted to lay in bed. He did vomit one time. He had loss of appetite. He wanted to know if someone could provide advice, that he should get second dose or not. He lost a few pounds in the last week. He was still in a fog. Injection site pain went away the following day. Other than having stomach pain, he doesn't feel that bad. The headache lasted 3 days. Therapeutic measures were taken as a result of headache. He has been on Tylenol. Stomach pain was not as bad as it was for 4 days. He was feeling feverish though. Regarding loss of appetite, he did eat something for breakfast, but that was it. The foggy feeling lasted until 02 Jun 2021 (yesterday as reported) and improved on 03Jun2021 (today as reported). All of symptoms kicked in on 29 May 2021. He added that in his left ankle, he does not know how to describe it. It was not like an electric shock but a twitching. It only lasted one day and went away. The injection did not hurt and did not hit bone. He feels sure it was given in the muscle. He took blood pressure medication and never had any reaction. He did not think it was relevant. His cholesterol and blood pressure were good now. He had a test for his heart a couple of years ago. The doctor said one of his arteries for his age looks like it was pretty normal, but one had a build-up in it. The case was assessed as non-serious. Outcome of events Muscle twitching, Feeling abnormal, Decreased appetite, Vomiting, Pyrexia, Fatigue and Malaise was recovering while outcome of Abdominal pain upper was not recovered and unknown for weight decreased. Patient was recovered from Vaccination site pain and Headache on an unknown date and Chills on 29May2021.

Some soreness in arm; heat around injection; This is a spontaneous report from a contactable consumer (patient). A 65-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number and expiry date were not reported) via unspecified route of administration in left arm on 08Mar2021 at 07:45 as single dose for COVID-19 immunisation. Medical history included pre-COPD (chronic obstructive pulmonary disease), allergy to penicillin, dairy and seasonal pollen. Concomitant medication included allopurinol, tiotropium bromide (SPIRIVA), rosuvastatin. Patient did not receive other vaccine in four weeks of vaccination. Patient did not receive any other medications in two weeks of vaccination. On 08Mar2021 at 11:00 patient experienced some soreness in arm and heat around injection site. No treatment received for adverse events. Patient was not diagnosed with COVID, prior vaccination. Patient had not been tested for COVID, post vaccination. The outcome of event was recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Rash over body Went to Dermologist for Predizone 20 mg, Hydroxyzine 50og and lotion Closetosac Waited on phone for aver a hour; This is a spontaneous report from a contactable consumer (patient himself). A 65-years-old male patient received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EM9810),via an unspecified route of administration in left arm on 27Feb2021 13:30 as a single dose for COVID-19 immunization and the patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EL9265),via an unspecified route of administration, administered in left arm on 01Feb2021 01:30 as 1st Dose, single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had no known allergies. 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 was not tested for COVID-19 since the vaccination. The patient did not receive any other medications within 2 weeks prior. On an unknown date, the patient experienced rash over body went to dermologist for predizone 20 mg, hydroxyzine 50og and lotion closetosac waited on phone for aver an hour. Therapeutic measures were taken as a result predizone 20 mg, hydroxyzine 50og and lotion closetosac. The outcome for the events was not recovered. No follow-up attempts are possible. No further information is expected. Follow-Up (15Jun2021): Follow-up attempts are completed. No further information is expected.

Rash on Elbows and Knees.; This is a spontaneous report from a contactable consumer. A 65-years-old-male patient received dose 1 as single of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6201,) (at the age of 65-years-old) on 23Feb2021 and 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6207) on 17Mar2021 at 03:30 PM, both doses via an unspecified route of administration into left arm for COVID-19 immunisation. Medical history of the patient includes bladder cancer, renal cell carcinoma, heart disease and chronic kidney disease from an unknown date. No concomitant medications were reported. The patient had an allergy towards Egg yolk. Prior to vaccination and since the vaccination the patient had not been diagnosed with COVID-19. The patient experienced rash on elbows and knees on 07Mar2021.The outcome of the event patient was not resolved. No follow-up attempts are possible, no further information is expected.

Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Additional Details: Patient said they experienced redness, swelling, and itching of the face, specifically around the eyes, which began the same day as the COVID-19 vaccine administration. The patient said they were "OK" and did not have to go to the hospital, however, they made an appointment to follow up with their doctor.

right lower extremity swelling and redness. He had an outpatient venous duplex of his RLE done earlier in the day and was referred to the ED due to extensive DVT. Heparin Drip

itchy rash; Redness on my face; This is a spontaneous report received from a contactable consumer, the patient. A 65-year-old male patient received unknown single dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot no: Ep6955) via unspecified route of administration on the left arm on 17Mar2021 at 15:15, for COVID-19 immunisation. No medical history and the patient concomitant medications were not reported and he had no known allergies. Prior to vaccination, patient was not diagnosed with COVID-19 and since the vaccination the patient was not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 18Mar2021, at 12:30 the patient had itchy rash on the wrist about 30 hours after the vaccination, the rash spread overnight and itching felt worst and also the patient developed redness on the face. Treatment medications for the events included the use of BENADRYL. Also, it was reported that the redness on face improved after taking half a pill of Benadryl. The clinical outcome of itchy rash was not recovered and redness in the face was recovering at the time of this report. No follow-up attempts are needed. No further information is expected.

can't really sleep; injection site pain to his right arm; pain at the top of his arm going down his arm/ the whole arm itself just hurts; pain at the top of his arm going down his arm/ arm hurts/when he turn had pain up his armpit; when he turns his neck to the right he has pain up his armpit; This is a spontaneous report from a two contactable consumer (patient and his wife). A 65-year-old male patient received bnt162b2 (Pfizer-Biontech COVID-19 Vaccine, Batch/Lot Number: unspecified), via an unspecified route of administration on 30Jan2021 (age at the time of vaccine 65-year-old) as 1st dose, 0.3 mL, single dose on right arm for COVID-19 immunisation. The patient's medical history was not reported. Concomitant medications were not specified but taking for blood pressure unspecified medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No additional vaccines administered on same date of the pfizer suspect. On 01Feb2021, the patient experienced pain at the top of his arm going down his arm/ the whole arm itself just hurts/when he turns his neck to the right, he had pain up his armpit. On an unspecified date, the patient could not really sleep and had injection site pain on his right arm had kept him awake. The patient stated he was calling about the Pfizer BioNTech COVID19 vaccine and stated he had been having a reaction of side effects and asking how long the side effects could last. The patient stated that for the first couple of days after getting the vaccine he had nothing and then the pain started a little bit on Monday and then on Tuesday the pain got a little worse; stated that last night the pain was beginning to keep him up from sleep. The patient stated all the adverse events are ongoing. The patient's wife stated the indication for which the patient received the vaccine was they are trying to be safe, and the patient's HCP called him and asked the patient if he wanted to take the shot. The patient's wife stated they both received the vaccine. The patient stated he was given paperwork down at the site location where he got the shot but was given the paperwork after he was administered the shot and the paperwork was a list of side effects; stated if he had seen the list of side effects before, he was administered the shot, he probably would not have taken the shot. The patient's wife stated the patient received no testing or treatment for the reported events. The patient did not visit emergency room. The outcome of the events was not recovered. Follow-up attempts completed. No further information expected.

Only slight injection site pain for first shot. With the 2nd shot, I had pain at injection site that radiated into my shoulder 8-15 hours after initial injection. Noticed swollen lymph glands in armpit of vaccinated arm after 24 hrs. All these particular symptoms disappeared after 36-48 hrs. Along with these symptoms I began to have very loud tinnitus which I have suffered from for years but nothing to this volume. Approximately 11 days after the 2nd dose I came home from working a short day and after a meal began to feel like my blood pressure was up because my head felt pressured and I could tell my heart was racing. Checked my blood pressure and it was at rest 140/105 w/ 96 bpm. I am not on any bp meds because I have never been prone to high blood pressure. Bp prior to this occurrence has always been in the 117-120/76-80 range with a bpm of around 64-70. Chest pain radiate from front to back to front and stayed that way until I went to emergency room 3 days later believing I may have had a heart attack. I was administered an EKG, had blood serum tests and a CT scan - all of which were normal and or showing no signs of a heart attack. I was kept overnight for observation with blood being drawn middle of the night and vitals being monitored. The morning of the next day I was administered a stress test which I apparently passed no problem.

So, I started to have some epidermis outbreaks about a week after the second vaccine. Shortly, after that I had a poison ivy reaction, but this reaction was different in which it started to go, which is odd for poison ivy. I was having an overaction to certain irritants as well. I also would have an abnormal amount of warts that were showing up. I have a lot of epidermis outbreaks. I also have had terrible joint pains also which started a week after the second dose. I was not able to lift things or do normal activates. I am still having trouble with my joints.

initial shot on 2/26/2021....rash developed by 3/6/2021 by 3/9/2021 had painful lump in left breast... rash comes and goes... second shot on 3/18/2021... rash comes and goes... 0n 4/24/2021 had an ischemic stroke...

This is a spontaneous report from a contactable consumer, patient. A 65-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: En6198) via an unspecified route of administration on 02Mar2021 (at the age of 65-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Patient had no known allergies to medications, food or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other unspecified medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.The patient experienced itchy arm, itchy and watery eye on an unknown date in Mar2021.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 itchy arm and watery eye. The clinical outcome of itchy and watery eye was recovered on an unknown date in Mar2021. No follow-up attempts are needed. No further information is expected.

Exhausion; back ache; lightheaded; injection site pain; This is a spontaneous report from a contactable consumer or other non health care professional (patient himself). A 65-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EM9809), via an unspecified route of administration , administered in right deltoid on 05Feb2021 08:45 (at the age of 65-years-old) as a unknown dose, number, single for COVID-19 immunisation. Medical history included hypertension from an unknown date and unknown if ongoing, high cholesterol from an unknown date and unknown if ongoing. Concomitant medications included received within 2 weeks valsartan taken for an unspecified indication, start and stop date were not reported; furosemide taken for an unspecified indication, start and stop date were not reported; rosuvastatin taken for an unspecified indication, start and stop date were not reported; aspirin [acetylsalicylic acid] (ASPIRIN) taken for an unspecified indication, start and stop date were not reported; amlodipine besilate (CCB) taken for an unspecified indication, start and stop date were not reported. The patient had no allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No other vaccines within 4 weeks prior to the COVID vaccine. On 06Feb2021, the patient experienced exhausion, back ache, lightheaded, injection site pain. The patient did not receive any treatment for the adverse event. Seriousness of the case reported as No. The outcome of events was not recovered. Follow-up attempts completed. No further information expected.